WorldWideScience

Sample records for outcome measures proms

  1. Patient reported outcome measures (PROMs)

    DEFF Research Database (Denmark)

    Bech, Per; Austin, Stephen Fitzgerald; Lau, Marianne Engelbrecht

    2018-01-01

    INTRODUCTION: Patient-reported outcome measures (PROMs) for anxiety and depressive disorders are an important aspect of measurement-based care. AIM: The aim of the study was to perform a clinimetric analysis of two PROMs scales in patents with depression and anxiety. METHODS: Patients completed...... recruited from two Danish mental health centers with anxiety or depression. The standardization of the SCL-10 and WHO-5 by T-scores indicated that a T-score of 65 corresponding to being moderately in need of treatment and a T-score of 75 to be severely in need of treatment. The coefficient of alpha...... with anxiety or depression undergoing psychotherapy treatment....

  2. An introduction to patient-reported outcome measures (PROMs) in physiotherapy

    NARCIS (Netherlands)

    Kyte, D.G.; Calvert, M.; Wees, P.J. van der; Hove, R. Ten; Tolan, S.; Hill, J.C.

    2015-01-01

    The use of patient-reported outcome measures (PROMs) is set to rise in physiotherapy. PROMs provide additional 'patient-centred' data which is unique in capturing the patient's own opinion on the impact of their disease or disorder, and its treatment, on their life. Thus, PROMs are increasingly used

  3. An introduction to patient-reported outcome measures (PROMs) in physiotherapy.

    Science.gov (United States)

    Kyte, D G; Calvert, M; van der Wees, P J; ten Hove, R; Tolan, S; Hill, J C

    2015-06-01

    The use of patient-reported outcome measures (PROMs) is set to rise in physiotherapy. PROMs provide additional 'patient-centred' data which is unique in capturing the patient's own opinion on the impact of their disease or disorder, and its treatment, on their life. Thus, PROMs are increasingly used by clinicians to guide routine patient care, or for the purposes of audit, and are already firmly embedded in clinical research. This article seeks to summarise the key aspects of PROM use for physiotherapists, both in routine clinical practice and in the research setting, and highlights recent developments in the field. Generic and condition-specific PROMs are defined and examples of commonly used measures are provided. The selection of appropriate PROMs, and their effective use in the clinical and research settings is discussed. Finally, existing barriers to PROM use in practice are identified and recent physiotherapy PROM initiatives, led by the Royal Dutch Society for Physical Therapy are explored. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  4. Creating guidance for the use of patient reported outcome measures (PROMS) in clinical palliatieve care.

    NARCIS (Netherlands)

    Vliet, L.M. van; Harding, R.; Bausewein, C.; Payne, S.; Higginson, I.J.

    2014-01-01

    Introduction: Routine use of Patient Reported Outcome Measures (PROMs) in clinical practice can influence care but is not always achieved. One reason for this seems to be a lack of guidance on how to use PROMs in palliative care practice. This project aimed to provide such guidance. Aim(s) and

  5. A systematic review of patient reported outcome measures (PROMs) used in child and adolescent burn research.

    Science.gov (United States)

    Griffiths, C; Armstrong-James, L; White, P; Rumsey, N; Pleat, J; Harcourt, D

    2015-03-01

    Patient reported outcome measures (PROMs) can identify important information about patient needs and therapeutic progress. The aim of this review was to identify the PROMs that are being used in child and adolescent burn care and to determine the quality of such scales. Computerised and manual bibliographic searches of Medline, Social Sciences Index, Cinahl, Psychinfo, Psycharticles, AMED, and HAPI, were used to identify English-language articles using English-language PROMs from January 2001 to March 2013. The psychometric quality of the PROMs was assessed. 23 studies met the entry criteria and identified 32 different PROMs (31 generic, 1 burns-specific). Overall, the psychometric quality of the PROMs was low; only two generic scales (the Perceived Stigmatisation Questionnaire and the Social Comfort Scale) and only one burns-specific scale (the Children Burn Outcomes Questionnaire for children aged 5-18) had psychometric evidence relevant to this population. The majority of PROMs did not have psychometric evidence for their use with child or adolescent burn patients. To appropriately identify the needs and treatment progress of child and adolescent burn patients, new burns-specific PROMs need to be developed and validated to reflect issues that are of importance to this population. Crown Copyright © 2014. Published by Elsevier Ltd. All rights reserved.

  6. Application of validity theory and methodology to patient-reported outcome measures (PROMs): building an argument for validity.

    Science.gov (United States)

    Hawkins, Melanie; Elsworth, Gerald R; Osborne, Richard H

    2018-07-01

    Data from subjective patient-reported outcome measures (PROMs) are now being used in the health sector to make or support decisions about individuals, groups and populations. Contemporary validity theorists define validity not as a statistical property of the test but as the extent to which empirical evidence supports the interpretation of test scores for an intended use. However, validity testing theory and methodology are rarely evident in the PROM validation literature. Application of this theory and methodology would provide structure for comprehensive validation planning to support improved PROM development and sound arguments for the validity of PROM score interpretation and use in each new context. This paper proposes the application of contemporary validity theory and methodology to PROM validity testing. The validity testing principles will be applied to a hypothetical case study with a focus on the interpretation and use of scores from a translated PROM that measures health literacy (the Health Literacy Questionnaire or HLQ). Although robust psychometric properties of a PROM are a pre-condition to its use, a PROM's validity lies in the sound argument that a network of empirical evidence supports the intended interpretation and use of PROM scores for decision making in a particular context. The health sector is yet to apply contemporary theory and methodology to PROM development and validation. The theoretical and methodological processes in this paper are offered as an advancement of the theory and practice of PROM validity testing in the health sector.

  7. The PU-PROM: A patient-reported outcome measure for peptic ulcer disease.

    Science.gov (United States)

    Liu, Na; Lv, Jing; Liu, Jinchun; Zhang, Yanbo

    2017-12-01

    Patient-reported outcome measure (PROM) conceived to enable description of treatment-related effects, from the patient perspective, bring the potential to improve in clinical research, and to provide patients with accurate information. Therefore, the aim of this study was to develop a patient-centred peptic ulcer patient-reported outcome measure (PU-PROM) and evaluate its reliability, validity, differential item functioning (DIF) and feasibility. To develop a conceptual framework and item pool for the PU-PROM, we performed a literature review and consulted other measures created in China and other countries. Beyond that, we interviewed 10 patients with peptic ulcers, and consulted six key experts to ensure that all germane parameters were included. In the first item selection phase, classical test theory and item response theory were used to select and adjust items to shape the preliminary measure completed by 130 patients and 50 controls. In the next phase, the measure was evaluated used the same methods with 492 patients and 124 controls. Finally, we used the same population in the second item reselection to assess the reliability, validity, DIF and feasibility of the final measure. The final peptic ulcer PRO measure comprised four domains (physiology, psychology, society and treatment), with 11 subdomains, and 54 items. The Cronbach's α coefficient of each subdomain for the measure was >0.800. Confirmatory factory analysis indicated that the construct validity fulfilled expectations. Model fit indices, such as RMR, RMSEA, NFI, NNFI, CFI and IFI, showed acceptable fit. The measure showed a good response rate. The peptic ulcer PRO measure had good reliability, validity, DIF and feasibility, and can be used as a clinical research evaluation instrument with patients with peptic ulcers to assess their condition focus on treatment. This measure may also be applied in other health areas, especially in clinical trials of new drugs, and may be helpful in clinical

  8. Patient-reported outcome measures (PROMs) for assessing perceived listening effort in hearing loss: protocol for a systematic review

    Science.gov (United States)

    Rapport, Frances L; Boisvert, Isabelle; McMahon, Catherine M; Hutchings, Hayley A

    2017-01-01

    Introduction In the UK, it is estimated that a disabling hearing loss (HL) affects 1 in 6 people. HL has functional, economic and social-emotional consequences for affected individuals. Intervention for HL focuses on improving access to the auditory signal using hearing aids or cochlear implants. However, even if sounds are audible and speech is understood, individuals with HL often report increased effort when listening. Listening effort (LE) may be measured using self-reported measures such as patient-reported outcome measures (PROMs). PROMs are validated questionnaires completed by patients to measure their perceptions of their own functional status and well-being. When selecting a PROM for use in research or clinical practice, it is necessary to appraise the evidence of a PROM’s acceptability to patients, validity, responsiveness and reliability. Methods and analysis A systematic review of studies evaluating the measurement properties of PROMs available to measure LE in HL will be undertaken. MEDLINE, EMBASE, CINAHL, PsychINFO and Web of Science will be searched electronically. Reference lists of included studies, key journals and the grey literature will be hand-searched to identify further studies for inclusion. Two reviewers will independently complete title, abstract and full-text screening to determine study eligibility. Data on the characteristics of each study and each PROM will be extracted. Methodological quality of the included studies will be appraised using the COnsensus-based Standards for the selection of health Measurement INstruments, the quality of included PROMs appraised and the credibility of the evidence assessed. A narrative synthesis will summarise extracted data. Ethics and dissemination Ethical permission is not required, as this study uses data from published research. Dissemination will be through publication in peer-reviewed journals, conference presentations and the lead author’s doctoral dissertation. Findings may inform the

  9. Proceedings of Patient Reported Outcome Measure?s (PROMs) Conference Sheffield 2016: advances in patient reported outcomes research

    OpenAIRE

    Croudace, Tim; Brazier, John; Gutacker, Nils; Street, Andrew; Robotham, Dan; Waterman, Samantha; Rose, Diana; Satkunanathan, Safarina; Wykes, Til; Nasr, Nasrin; Enderby, Pamela; Carlton, Jill; Rowen, Donna; Elliott, Jackie; Brazier, John

    2016-01-01

    Table of contents S1 Using computerized adaptive testing Tim Croudace S2 Well-being: what is it, how does it compare to health and what are the implications of using it to inform health policy John Brazier O1 “Am I going to get better?”—Using PROMs to inform patients about the likely benefit of surgery Nils Gutacker, Andrew Street O2 Identifying Patient Reported Outcome Measures for an electronic Personal Health Record Dan Robotham, Samantha Waterman, Diana Rose, Safarina Satkunanathan, Til W...

  10. Patient reported outcome measures (PROMs) following forward planned field-in field IMRT: Results from the Cambridge Breast IMRT trial

    International Nuclear Information System (INIS)

    Mukesh, Mukesh B.; Qian, Wendi; Wilkinson, Jennifer S.; Dorling, Leila; Barnett, Gillian C.; Moody, Anne M.; Wilson, Charles; Twyman, Nicola; Burnet, Neil G.; Wishart, Gordon C.; Coles, Charlotte E.

    2014-01-01

    Background: The use of intensity-modulated radiotherapy (IMRT) in breast cancer reduces clinician-assessed breast tissue toxicity including fibrosis, telangectasia and sub-optimal cosmesis. Patient reported outcome measures (PROMs) are also important as they provide the patient’s perspective. This longitudinal study reports on (a) the effect of forward planned field-in-field IMRT (∼simple IMRT) on PROMs compared to standard RT at 5 years after RT, (b) factors affecting PROMs at 5 years after RT and (c) the trend of PROMs over 5 years of follow up. Methods: PROMs were assessed at baseline (pre-RT), 6, 24 and 60 months after completion of RT using global health (EORTC QLQ C30) and 4 breast symptom questions (BR23). Also, 4 breast RT-specific questions were included at 6, 24 and 60 months: change in skin appearance, firmness to touch, reduction in breast size and overall change in breast appearance since RT. The benefits of simple IMRT over standard RT at 5 years after RT were assessed using standard t-test for global health and logistic regression analysis for breast symptom questions and breast RT-specific questions. Clinical factors affecting PROMs at 5 years were investigated using a multivariate analysis. A repeated mixed model was applied to explore the trend over time for each of PROMs. Results: (89%) 727/815, 84%, 81% and 61% patients completed questionnaires at baseline, 6, 24 and 60 months respectively. Patients reported worse toxicity for all four BR23 breast symptoms at 6 months, which then improved over time (p < 0.0001). They also reported improvement in skin appearance and breast hardness over time (p < 0.0001), with no significant change for breast shrinkage (p = 0.47) and overall breast appearance (p = 0.13). At 5 years, PROMs assessments did not demonstrate a benefit for simple IMRT over standard radiotherapy. Large breast volume, young age, baseline surgical cosmesis and post-operative infection were the most important variables to affect PROMs

  11. Measurement properties of patient-reported outcome measures (PROMs) used in adult patients with chronic kidney disease: a systematic review protocol.

    Science.gov (United States)

    Aiyegbusi, Olalekan Lee; Kyte, Derek; Cockwell, Paul; Marshall, Tom; Keeley, Thomas; Gheorghe, Adrian; Calvert, Melanie

    2016-10-12

    Chronic kidney disease (CKD) is associated with symptoms that can significantly reduce the quality of life (QoL) of patients. Patient-reported outcome measures (PROMs) may facilitate the assessment of the impact of disease and treatment on the QoL, from a patient perspective. PROMs can be used in research and routine clinical practice. A systematic review of studies evaluating the measurement properties of PROMs in adults with CKD will be conducted. MEDLINE, EMBASE, PsycINFO and CINAHL Plus will be systematically searched from inception. Hand searching of reference lists and citations of included studies will be carried out. 2 reviewers will independently screen the titles and abstracts of all the studies retrieved during the systematic search to determine their eligibility. The COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) checklist will be used to appraise the methodological quality of the selected studies following the full-text review. Data on the study population, questionnaire characteristics and measurement properties will be extracted from the selected papers. Finally, a narrative synthesis of extracted data will be undertaken. Ethical permissions are not required for this study as data from published research articles will be used. Findings will be disseminated through publication in a peer-reviewed journal and presented at conferences. This systematic review will provide a comprehensive assessment of the measurement properties of PROMs currently available for use in adult patients with CKD and present evidence which may inform the selection of measures for use in research and clinical practice. CRD42016035554. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  12. Proceedings of Patient Reported Outcome Measure’s (PROMs) Conference Oxford 2017: Advances in Patient Reported Outcomes Research

    NARCIS (Netherlands)

    Velikova, Galina; Valderas, Jose M.; Potter, Caroline; Batchelder, Laurie; A’Court, Christine; Baker, Matthew; Bostock, Jennifer; Coulter, Angela; Fitzpatrick, Ray; Forder, Julien; Fox, Diane; Geneen, Louise; Gibbons, Elizabeth; Jenkinson, Crispin; Jones, Karen; Kelly, Laura; Peters, Michele; Mulhern, Brendan; Labeit, Alexander; Rowen, Donna; Meadows, Keith; Elliott, Jackie; Brazier, John E.; Knowles, Emma; Keetharuth, Anju; Brazier, John E.; Connell, Janice; Carlton, Jill; Buck, Lizzie Taylor; Ricketts, Thomas; Barkham, Michael; Goswami, Pushpendra; Salek, Sam; Ionova, Tatyana; Oliva, Esther; Fielding, Adele K.; Karakantza, Marina; Al-Ismail, Saad; Collins, Graham P.; McConnell, Stewart; Langton, Catherine; Jennings, Daniel M.; Else, Roger; Kell, Jonathan; Ward, Helen; Day, Sophie; Lumley, Elizabeth; Phillips, Patrick; Duncan, Rosie; Buckley-Woods, Helen; Aber, Ahmed; Jones, Gerogina; Michaels, Jonathan; Porter, Ian; Gangannagaripalli, Jaheeda; Davey, Antoinette; Ricci-Cabello, Ignacio; Haywood, Kirstie; Hansen, Stine Thestrup; Valderas, Jose; Roberts, Deb; Gumber, Anil; Podmore, Bélène; Hutchings, Andrew; van der Meulen, Jan; Aggarwal, Ajay; Konan, Sujith; Price, Andrew; Jackson, William; Bottomley, Nick; Philiips, Michael; Knightley-Day, Toby; Beard, David; Gibbons, Elizabeth; Fitzpatrick, Ray; Greenhalgh, Joanne; Gooding, Kate; Gibbons, Elizabeth; Valderas, Chema; Wright, Judy; Dalkin, Sonia; Meads, David; Black, Nick; Fawkes, Carol; Froud, Robert; Carnes, Dawn; Price, Andrew; Cook, Jonathan; Dakin, Helen; Smith, James; Kang, Sujin; Beard, David; Griffiths, Catrin; Guest, Ella; Harcourt, Diana; Murphy, Mairead; Hollinghurst, Sandra; Salisbury, Chris; Carlton, Jill; Elliott, Jackie; Rowen, Donna; Gao, Anqi; Price, Andrew; Beard, David; Lemanska, Agnieszka; Chen, Tao; Dearnaley, David P.; Jena, Rajesh; Sydes, Matthew; Faithfull, Sara; Ades, A. E.; Kounali, Daphne; Lu, Guobing; Rombach, Ines; Gray, Alastair; Jenkinson, Crispin; Rivero-Arias, Oliver; Holch, Patricia; Holmes, Marie; Rodgers, Zoe; Dickinson, Sarah; Clayton, Beverly; Davidson, Susan; Routledge, Jacqui; Glennon, Julia; Henry, Ann M.; Franks, Kevin; Velikova, Galina; Maguire, Roma; McCann, Lisa; Young, Teresa; Armes, Jo; Harris, Jenny; Miaskowski, Christine; Kotronoulas, Grigorios; Miller, Morven; Ream, Emma; Patiraki, Elizabeth; Geiger, Alexander; Berg, Geir V.; Flowerday, Adrian; Donnan, Peter; McCrone, Paul; Apostolidis, Kathi; Fox, Patricia; Furlong, Eileen; Kearney, Nora; Gibbons, Chris; Fischer, Felix; Gibbons, Chris; Coste, Joel; Martinez, Jose Valderas; Rose, Matthias; Leplege, Alain; Shingler, Sarah; Aldhouse, Natalie; Al-Zubeidi, Tamara; Trigg, Andrew; Kitchen, Helen; Davey, Antoinette; Porter, Ian; Green, Colin; Valderas, Jose M.; Coast, Joanna; Smith, Sarah; Hendriks, Jolijn; Black, Nick; Shah, Koonal; Rivero-Arias, Oliver; Ramos-Goni, Juan-Manuel; Kreimeier, Simone; Herdman, Mike; Devlin, Nancy; Finch, Aureliano Paolo; Brazier, John E.; Mukuria, Clara; Zamora, Bernarda; Parkin, David; Feng, Yan; Bateman, Andrew; Herdman, Mike; Devlin, Nancy; Patton, Thomas; Gutacker, Nils; Shah, Koonal

    2017-01-01

    The proceedings contain 36 papers. The topics discussed include: using patient reported outcome measures (PROMs) in cancer care; validation of the long-term conditions questionnaire (LTCQ) in a diverse sample of health and social care users in England; the national institutes of health

  13. PROMs for pain in adult cancer patients: a systematic review of measurement properties.

    Science.gov (United States)

    Abahussin, Asma A; West, Robert M; Wong, David C; Ziegler, Lucy E

    2018-05-17

    Pain is one of the most devastating symptoms for cancer patients. One-third of patients who experience pain do not receive effective treatment. A key barrier to effective pain management is lack of routine measurement and monitoring of pain. Patient-Reported Outcome Measures (PROMs) are recommended for measuring cancer pain. However, evidence to guide the selection of the most appropriate measure to identify and monitor cancer pain is limited. A systematic review of measurement properties of PROMs for pain in cancer patients is needed to identify the best validated measure for adoption to an electronic platform. Systematically review measurement properties of PROMs used for adult cancer patients to measure pain and, as a secondary goal, investigate the evidence of validated mobile health (mHealth) applications used to measure pain (registration number: CRD42017065575). Medline, EMBASE and CINAHL were systematically searched in March 2018 for studies examining measurement properties for PROMs for pain in adult cancer patients. Both of the methodological quality of the studies and their results were appraised using the COSMIN checklist and specific measurement properties criteria respectively. Sixteen studies evaluating eight instruments were included. No studies using a PROM in a mHealth application were identified. The methodological quality of the measurement properties ranged between poor and fair. No instrument showed strong positive evidence for all the evaluated measurement properties. Based on the available evidence, the Brief Pain Inventory-Short Form (BPI-SF) had the strongest evidence to support its selection for the measurement of cancer pain. The BPI-SF was the best performing measure across all proprieties evaluated through COSMIN. Better quality validation studies of PROMs for cancer pain are needed to explore the full range of measurement properties. Utilising mHealth applications for measuring pain for cancer patients is an innovative approach worth

  14. Proceedings of Patient Reported Outcome Measure’s (PROMs Conference Sheffield 2016: advances in patient reported outcomes research

    Directory of Open Access Journals (Sweden)

    Tim Croudace

    2016-10-01

    Full Text Available Table of contents S1 Using computerized adaptive testing Tim Croudace S2 Well-being: what is it, how does it compare to health and what are the implications of using it to inform health policy John Brazier O1 “Am I going to get better?”—Using PROMs to inform patients about the likely benefit of surgery Nils Gutacker, Andrew Street O2 Identifying Patient Reported Outcome Measures for an electronic Personal Health Record Dan Robotham, Samantha Waterman, Diana Rose, Safarina Satkunanathan, Til Wykes O3 Examining the change process over time qualitatively: transformative learning and response shift Nasrin Nasr, Pamela Enderby O4 Developing a PROM to evaluate self-management in diabetes (HASMID: giving patients a voice Jill Carlton, Donna Rowen, Jackie Elliott, John Brazier, Katherine Stevens, Hasan Basarir, Alex Labeit O5 Development of the Primary Care Outcomes Questionnaire (PCOQ Mairead Murphy, Sandra Hollinghurst, Chris Salisbury O6 Developing the PKEX score- a multimodal assessment tool for patients with shoulder problems Dominic Marley, James Wilson, Amy Barrat, Bibhas Roy O7 Applying multiple imputation to multi-item patient reported outcome measures: advantages and disadvantages of imputing at the item, sub-scale or score level Ines Rombach, Órlaith Burke, Crispin Jenkinson, Alastair Gray, Oliver Rivero-Arias O8 Integrating Patient Reported Outcome Measures (PROMs into routine primary care for patients with multimorbidity: a feasibility study Ian Porter, Jaheeda Gangannagaripalli, Charlotte Bramwell, Jose M. Valderas O9 eRAPID: electronic self-report and management of adverse-events for pelvic radiotherapy (RT patients Patricia Holch, Susan Davidson, Jacki Routledge, Ann Henry, Kevin Franks, Alex Gilbert, Kate Absolom & Galina Velikova O10 Patient reported outcomes (PROMs based recommendation in clinical guidance for the management of chronic conditions in the United Kingdom Ian Porter, Jose M.Valderas O11 Cross-sectional and

  15. Measuring Patient-Reported Outcomes: Key Metrics in Reconstructive Surgery.

    Science.gov (United States)

    Voineskos, Sophocles H; Nelson, Jonas A; Klassen, Anne F; Pusic, Andrea L

    2018-01-29

    Satisfaction and improved quality of life are among the most important outcomes for patients undergoing plastic and reconstructive surgery for a variety of diseases and conditions. Patient-reported outcome measures (PROMs) are essential tools for evaluating the benefits of newly developed surgical techniques. Modern PROMs are being developed with new psychometric approaches, such as Rasch Measurement Theory, and their measurement properties (validity, reliability, responsiveness) are rigorously tested. These advances have resulted in the availability of PROMs that provide clinically meaningful data and effectively measure functional as well as psychosocial outcomes. This article guides the reader through the steps of creating a PROM and highlights the potential research and clinical uses of such instruments. Limitations of PROMs and anticipated future directions in this field are discussed.

  16. Cross-cultural adaptation and measurement properties of generic and cancer-related patient-reported outcome measures (PROMs) for use with cancer patients in Brazil: a systematic review.

    Science.gov (United States)

    Albach, Carlos Augusto; Wagland, Richard; Hunt, Katherine J

    2018-04-01

    This systematic review (1) identifies the current generic and cancer-related patient-reported outcome measures (PROMs) that have been cross-culturally adapted to Brazilian Portuguese and applied to cancer patients and (2) critically evaluates their cross-cultural adaptation (CCA) and measurement properties. Seven databases were searched for articles regarding the translation and evaluation of measurement properties of generic and cancer-related PROMs cross-culturally adapted to Brazilian Portuguese that are applied in adult (≥18 years old) cancer patients. The methodological quality of included studies was assessed using the COSMIN checklist. The bibliographic search retrieved 1674 hits, of which seven studies analysing eight instruments were included in this review. Data on the interpretability of scores were poorly reported. Overall, the quality of the CCA process was inconsistent throughout the studies. None of the included studies performed a cross-cultural validation. The evidence concerning the quality of measurement properties is limited by poor or fair methodological quality. Moreover, limited information regarding measurement properties was provided within the included papers. This review aids the selection process of Brazilian Portuguese PROMs for use in cancer patients. After acknowledging the methodological caveats and strengths of each tool, our opinion is that for quality of life and symptoms assessment the adapted FACT-G version and the ESAS could be recommended, respectively. Future research should rely on the already accepted standards of CCA and validation studies.

  17. Patient-reported outcome measures in arthroplasty registries

    DEFF Research Database (Denmark)

    Rolfson, Ola; Eresian Chenok, Kate; Bohm, Eric

    2016-01-01

    survey (SF-12) or the similar Veterans RAND 12-item health survey (VR-12). The most common specific PROMs were the Hip disability and Osteoarthritis Outcome Score (HOOS), the Knee injury and Osteoarthritis Outcome Score (KOOS), the Oxford Hip Score (OHS), the Oxford Knee Score (OKS), the Western Ontario...... of PROMs for hip and knee arthroplasty in registries worldwide. The 2 main types of PROMs include generic (general health) PROMs, which provide a measure of general health for any health state, and specific PROMs, which focus on specific symptoms, diseases, organs, body regions, or body functions...... all elective hip or knee arthroplasty patients and 6 registries collected PROMs for sample populations; 1 other registry had planned but had not started collection of PROMs. The most common generic instruments used were the EuroQol 5 dimension health outcome survey (EQ-5D) and the Short Form 12 health...

  18. Enhancing rigour in the validation of patient reported outcome measures (PROMs: bridging linguistic and psychometric testing

    Directory of Open Access Journals (Sweden)

    Roberts Gwerfyl

    2012-06-01

    Full Text Available Abstract Background A strong consensus exists for a systematic approach to linguistic validation of patient reported outcome measures (PROMs and discrete methods for assessing their psychometric properties. Despite the need for robust evidence of the appropriateness of measures, transition from linguistic to psychometric validation is poorly documented or evidenced. This paper demonstrates the importance of linking linguistic and psychometric testing through a purposeful stage which bridges the gap between translation and large-scale validation. Findings Evidence is drawn from a study to develop a Welsh language version of the Beck Depression Inventory-II (BDI-II and investigate its psychometric properties. The BDI-II was translated into Welsh then administered to Welsh-speaking university students (n = 115 and patients with depression (n = 37 concurrent with the English BDI-II, and alongside other established depression and quality of life measures. A Welsh version of the BDI-II was produced that, on administration, showed conceptual equivalence with the original measure; high internal consistency reliability (Cronbach’s alpha = 0.90; 0.96; item homogeneity; adequate correlation with the English BDI-II (r = 0.96; 0.94 and additional measures; and a two-factor structure with one overriding dimension. Nevertheless, in the student sample, the Welsh version showed a significantly lower overall mean than the English (p = 0.002; and significant differences in six mean item scores. This prompted a review and refinement of the translated measure. Conclusions Exploring potential sources of bias in translated measures represents a critical step in the translation-validation process, which until now has been largely underutilised. This paper offers important findings that inform advanced methods of cross-cultural validation of PROMs.

  19. Using Patient Reported Outcomes Measures to Promote Integrated Care

    Directory of Open Access Journals (Sweden)

    Marcel G. M. Olde Rikkert

    2018-04-01

    Full Text Available Introduction: Patient reported outcome measures (PROMs have been introduced as standardised outcomes, but have not been implemented widely for disease targeted pathways of care, nor for geriatric patients who prefer functional performance and quality of life. Discussion: We describe innovative multipurpose implementation of PROMs as evidenced by two best practices of PROMs application in geriatric and physiotherapy practice. We show that PROMs can show meaningful outcomes in older subjects’ patient journeys, which can at the same time serve individuals and groups of both patients and professionals. Key lesson: PROMs can deliver generic outcomes relevant for older patients, may improve patient-physician relationship, quality of care and prediction of future outcomes in geriatric care, if they are valid, reliable and responsive, but still short and simple. A precondition to make the hard tip from research to practice is that PROMs are carefully positioned in the clinical encounters and in electronic health records.

  20. Measuring outcomes in adult spinal deformity surgery: a systematic review to identify current strengths, weaknesses and gaps in patient-reported outcome measures.

    Science.gov (United States)

    Faraj, Sayf S A; van Hooff, Miranda L; Holewijn, Roderick M; Polly, David W; Haanstra, Tsjitske M; de Kleuver, Marinus

    2017-08-01

    Adult spinal deformity (ASD) causes severe disability, reduces overall quality of life, and results in a substantial societal burden of disease. As healthcare is becoming more value based, and to facilitate global benchmarking, it is critical to identify and standardize patient-reported outcome measures (PROMs). This study aims to identify the current strengths, weaknesses, and gaps in PROMs used for ASD. Studies were included following a systematic search in multiple bibliographic databases between 2000 and 2015. PROMs were extracted and linked to the outcome domains of WHO's International Classification of Functioning and Health (ICF) framework. Subsequently, the clinimetric quality of identified PROMs was evaluated. The literature search identified 144 papers that met the inclusion criteria, and nine frequently used PROMs were identified. These covered 29 ICF outcome domains, which could be grouped into three of the four main ICF chapters: body function (n = 7), activity and participation (n = 19), environmental factors (n = 3), and body structure (n = 0). A low quantity (n = 3) of papers was identified that studied the clinimetric quality of PROMs. The Scoliosis Research Society (SRS)-22 has the highest level of clinimetric quality for ASD. Outcome domains related to mobility and pain were well represented. We identified a gap in current outcome measures regarding neurological and pulmonary function. In addition, no outcome domains were measured in the ICF chapter body structure. These results will serve as a foundation for the process of seeking international consensus on a standard set of outcome domains, accompanied PROMs and contributing factors to be used in future clinical trials and spine registries.

  1. An Independent Psychometric Evaluation of the PROMS Measure of Music Perception Skills.

    Science.gov (United States)

    Kunert, Richard; Willems, Roel M; Hagoort, Peter

    2016-01-01

    The Profile of Music Perception Skills (PROMS) is a recently developed measure of perceptual music skills which has been shown to have promising psychometric properties. In this paper we extend the evaluation of its brief version to three kinds of validity using an individual difference approach. The brief PROMS displays good discriminant validity with working memory, given that it does not correlate with backward digit span (r = .04). Moreover, it shows promising criterion validity (association with musical training (r = .45), musicianship status (r = .48), and self-rated musical talent (r = .51)). Finally, its convergent validity, i.e. relation to an unrelated measure of music perception skills, was assessed by correlating the brief PROMS to harmonic closure judgment accuracy. Two independent samples point to good convergent validity of the brief PROMS (r = .36; r = .40). The same association is still significant in one of the samples when including self-reported music skill in a partial correlation (rpartial = .30; rpartial = .17). Overall, the results show that the brief version of the PROMS displays a very good pattern of construct validity. Especially its tuning subtest stands out as a valuable part for music skill evaluations in Western samples. We conclude by briefly discussing the choice faced by music cognition researchers between different musical aptitude measures of which the brief PROMS is a well evaluated example.

  2. Evaluation of measurement properties of self-administered PROMs aimed at patients with non-specific shoulder pain and "activity limitations": a systematic review.

    Science.gov (United States)

    Thoomes-de Graaf, M; Scholten-Peeters, G G M; Schellingerhout, J M; Bourne, A M; Buchbinder, R; Koehorst, M; Terwee, C B; Verhagen, A P

    2016-09-01

    To critically appraise and compare the measurement properties of self-administered patient-reported outcome measures (PROMs) focussing on the shoulder, assessing "activity limitations." Systematic review. The study population had to consist of patients with shoulder pain. We excluded postoperative patients or patients with generic diseases. The methodological quality of the selected studies and the results of the measurement properties were critically appraised and rated using the COSMIN checklist. Out of a total of 3427 unique hits, 31 articles, evaluating 7 different questionnaires, were included. The SPADI is the most frequently evaluated PROM and its measurement properties seem adequate apart from a lack of information regarding its measurement error and content validity. For English, Norwegian and Turkish users, we recommend to use the SPADI. Dutch users could use either the SDQ or the SST. In German, we recommend the DASH. In Tamil, Slovene, Spanish and the Danish languages, the evaluated PROMs were not yet of acceptable validity. None of these PROMs showed strong positive evidence for all measurement properties. We propose to develop a new shoulder PROM focused on activity limitations, taking new knowledge and techniques into account.

  3. Using Patient-Reported Outcome Measures (PROMs) to promote quality of care and safety in the management of patients with Advanced Chronic Kidney disease (PRO-trACK project): a mixed-methods project protocol.

    Science.gov (United States)

    Aiyegbusi, Olalekan Lee; Kyte, Derek; Cockwell, Paul; Marshall, Tom; Dutton, Mary; Slade, Anita; Marklew, Neil; Price, Gary; Verdi, Rav; Waters, Judi; Sharpe, Keeley; Calvert, Melanie

    2017-06-30

    Advanced chronic kidney disease (CKD) has a major effect on the quality of life and health status of patients and requires accurate and responsive management. The use of electronic patient-reported outcome measures (ePROMs) could assist patients with advanced pre-dialysis CKD, and the clinicians responsible for their care, by identifying important changes in symptom burden in real time. We report the protocol for 'Using Patient-Reported Outcome measures (PROMs) to promote quality of care and safety in the management of patients with Advanced Chronic Kidney Disease' (PRO-trACK) project, which will explore the feasibility and validity of an ePROM system for use in patients with advanced CKD. The project will use a mixed-methods approach in three studies: (1) usability testing of the ePROM system involving up to 30 patients and focusing on acceptability and technical performance/stability; (2) ascertaining the views of patient and clinician stakeholders on the optimal use and administration of the CKD ePROM system-this will involve qualitative face-to-face/telephone interviewing with up to 30 patients or until saturation is achieved, focus groups with up to 15 clinical staff, management and IT team members; (3) psychometric assessment of the system, within a cohort of at least 180 patients with advanced CKD, to establish the measurement properties of the ePROM. This project was approved by the West Midlands Edgbaston Research Ethics Committee (Reference 17/WM/0010) and received Health Research Authority (HRA) approval on 24 February 2017.The findings from this project will be provided to clinicians at the Department of Renal Medicine, Queen Elizabeth Hospitals, Birmingham (QEHB), NHS England, presented at conferences and to the Kidney Patients' Association, British Kidney Patient Association and the British Renal Society. Articles based on the findings will be written and submitted for publication in peer-reviewed journals. © Article author(s) (or their employer

  4. Measurement properties of patient reported outcome measures for spondyloarthritis: A systematic review.

    Science.gov (United States)

    Png, Kelly; Kwan, Yu Heng; Leung, Ying Ying; Phang, Jie Kie; Lau, Jia Qi; Lim, Ka Keat; Chew, Eng Hui; Low, Lian Leng; Tan, Chuen Seng; Thumboo, Julian; Fong, Warren; Østbye, Truls

    2018-03-21

    This systematic review aimed to identify studies investigating measurement properties of patient reported outcome measures (PROMs) for spondyloarthritis (SpA), and to evaluate their methodological quality and level of evidence relating to the measurement properties of PROMs. This systematic review was guided by the preferred reporting items for systematic review and meta-analysis (PRISMA). Articles published before 30 June 2017 were retrieved from PubMed ® , Embase ® , and PsychINFO ® (Ovid). Methodological quality and level of evidence were evaluated according to recommendations from the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN). We identified 60 unique PROMs from 125 studies in 39 countries. Twenty-one PROMs were validated for two or more SpA subtypes. The literature examined hypothesis testing (82.4%) most frequently followed by reliability (60.0%). A percentage of 77.7% and 42.7% of studies that assessed PROMs for hypothesis testing and reliability, respectively had "fair" or better methodological quality. Among the PROMs identified, 41.7% were studied in ankylosing spondylitis (AS) only and 23.3% were studied in psoriatic arthritis (PsA) only. The more extensively assessed PROMs included the ankylosing spondylitis quality of life (ASQoL) and bath ankylosing spondylitis functional index (BASFI) for ankylosing spondylitis, and the psoriatic arthritis quality of life questionnaire (VITACORA-19) for psoriatic arthritis. This study identified 60 unique PROMs through a systematic review and synthesized evidence of the measurement properties of the PROMs. There is a lack of validation of PROMs for use across SpA subtypes. Future studies may consider validating PROMs for use across different SpA subtypes. Copyright © 2018 Elsevier Inc. All rights reserved.

  5. A new anti-microbial combination prolongs the latency period, reduces acute histologic chorioamnionitis as well as funisitis, and improves neonatal outcomes in preterm PROM.

    Science.gov (United States)

    Lee, JoonHo; Romero, Roberto; Kim, Sun Min; Chaemsaithong, Piya; Park, Chan-Wook; Park, Joong Shin; Jun, Jong Kwan; Yoon, Bo Hyun

    2016-03-01

    Antibiotic administration is a standard practice in preterm premature rupture of membranes (PROM). Specific anti-microbial agents often include ampicillin and/or erythromycin. Anaerobes and genital mycoplasmas are frequently involved in preterm PROM, but are not adequately covered by antibiotics routinely used in clinical practice. Our objective was to compare outcomes of PROM treated with standard antibiotic administration versus a new combination more effective against these bacteria. A retrospective study compared perinatal outcomes in 314 patients with PROM 23 ng/mL). (1) Patients treated with regimen 2 had a longer median antibiotic-to-delivery interval than those with regimen 1 [median (interquartile range) 23 d (10-51 d) versus 12 d (5-52 d), p acute histologic chorioamnionitis (50.5% versus 66.7%, p hemorrhage (IVH) and cerebral palsy (CP) were significantly lower in patients allocated to regimen 2 than regimen 1 (IVH: 2.1% versus 19.0%, p acute histologic chorioamnionitis/funisitis, and improved neonatal outcomes in patients with preterm PROM. These findings suggest that the combination of anti-microbial agents (ceftriaxone, clarithromycin, and metronidazole) may improve perinatal outcome in preterm PROM.

  6. Patient-reported outcome measures in arthroplasty registries

    DEFF Research Database (Denmark)

    Rolfson, Ola; Bohm, Eric; Franklin, Patricia

    2016-01-01

    The International Society of Arthroplasty Registries (ISAR) Patient-Reported Outcome Measures (PROMs) Working Group have evaluated and recommended best practices in the selection, administration, and interpretation of PROMs for hip and knee arthroplasty registries. The 2 generic PROMs in common use...... are the Short Form health surveys (SF-36 or SF-12) and EuroQol 5-dimension (EQ-5D). The Working Group recommends that registries should choose specific PROMs that have been appropriately developed with good measurement properties for arthroplasty patients. The Working Group recommend the use of a 1-item pain...... should consider the absolute level of pain, function, and general health status as well as improvement, missing data, approaches to analysis and case-mix adjustment, minimal clinically important difference, and minimal detectable change. The Working Group recommends data collection immediately before...

  7. Patient-reported outcome measures versus inertial performance-based outcome measures: A prospective study in patients undergoing primary total knee arthroplasty.

    Science.gov (United States)

    Bolink, S A A N; Grimm, B; Heyligers, I C

    2015-12-01

    Outcome assessment of total knee arthroplasty (TKA) by subjective patient reported outcome measures (PROMs) may not fully capture the functional (dis-)abilities of relevance. Objective performance-based outcome measures could provide distinct information. An ambulant inertial measurement unit (IMU) allows kinematic assessment of physical performance and could potentially be used for routine follow-up. To investigate the responsiveness of IMU measures in patients following TKA and compare outcomes with conventional PROMs. Patients with end stage knee OA (n=20, m/f=7/13; age=67.4 standard deviation 7.7 years) were measured preoperatively and one year postoperatively. IMU measures were derived during gait, sit-stand transfers and block step-up transfers. PROMs were assessed by using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Knee Society Score (KSS). Responsiveness was calculated by the effect size, correlations were calculated with Spearman's rho correlation coefficient. One year after TKA, patients performed significantly better at gait, sit-to-stand transfers and block step-up transfers. Measures of time and kinematic IMU measures demonstrated significant improvements postoperatively for each performance-based test. The largest improvement was found in block step-up transfers (effect size=0.56-1.20). WOMAC function score and KSS function score demonstrated moderate correlations (Spearman's rho=0.45-0.74) with some of the physical performance-based measures pre- and postoperatively. To characterize the changes in physical function after TKA, PROMs could be supplemented by performance-based measures, assessing function during different activities and allowing kinematic characterization with an ambulant IMU. Copyright © 2015 Elsevier B.V. All rights reserved.

  8. Measuring Quality and Outcomes in Sports Medicine.

    Science.gov (United States)

    Ruzbarsky, Joseph J; Marom, Niv; Marx, Robert G

    2018-07-01

    Patient-reported outcome measures (PROMs) are objective metrics critical to evaluating outcomes throughout orthopedic surgery. New instruments continue to emerge, increasing the breadth of information required for those intending to use these measures for research or clinical care. Although earlier metrics were developed using the principles of classic test theory, newer instruments constructed using item response theory are amenable to computer-adaptive testing and may change the way these instruments are administered. This article aims to define the psychometric properties that are important to understand when using all PROMs and to review the most widely used instruments in sports medicine. Copyright © 2018 Elsevier Inc. All rights reserved.

  9. How Do We Value Postoperative Recovery?: A Systematic Review of the Measurement Properties of Patient-reported Outcomes After Abdominal Surgery.

    Science.gov (United States)

    Fiore, Julio F; Figueiredo, Sabrina; Balvardi, Saba; Lee, Lawrence; Nauche, Bénédicte; Landry, Tara; Mayo, Nancy E; Feldman, Liane S

    2018-04-01

    To appraise the level of evidence supporting the measurement properties of patient-reported outcome measures (PROMs) in the context of postoperative recovery after abdominal surgery. There is growing interest in using PROMs to support value-based care in abdominal surgery; however, to draw valid conclusions regarding patient-reported outcomes data, PROMs with robust measurement properties are required. Eight databases (MEDLINE, EMBASE, Biosis, PsycINFO, The Cochrane Library, CINAHL, Scopus, Web of Science) were searched for studies focused on the measurement properties of PROMs in the context of recovery after abdominal surgery. The methodological quality of individual studies was evaluated using the consensus-based COSMIN checklist. Evidence supporting the measurement properties of each PROM was synthetized according to standardized criteria and compared against the International Society of Quality of Life Research minimum standards for the selection of PROMs for outcomes research. We identified 35 studies evaluating 22 PROMs [12 focused on nonspecific surgical populations (55%), 4 focused on abdominal surgery (18%), and 6 generic PROMs (27%)]. The great majority of the studies (74%) received only poor or fair quality ratings. Measurement properties of PROMs were predominantly supported by limited or unknown evidence. None of the PROMs fulfilled International Society of Quality of Life Research's minimum standards, hindering specific recommendations. There is very limited evidence supporting the measurement properties of existing PROMs used in the context of recovery after abdominal surgery. This precludes the use of these PROMs to support value-based surgical care. Further research is required to bridge this major knowledge gap. International Prospective Register of Systematic Reviews (PROSPERO): CRD42014014349.

  10. A systematic review of measurement properties of patient reported outcome measures in psoriatic arthritis

    DEFF Research Database (Denmark)

    Højgaard, Pil; Klokker, Louise; Orbai, Ana Maria

    2018-01-01

    Background: An updated psoriatic arthritis (PsA) core outcome set (COS) for randomized controlled trials (RCTs) was endorsed at the Outcome Measures in Rheumatology (OMERACT) meeting in 2016. Objectives: To synthesize the evidence on measurement properties of patient reported outcome measures...... (PROMs) for PsA and thereby contribute to development of a PsA core outcome measurement set (COMS) as described by the OMERACT Filter 2.0. Methods: A systematic literature search was performed in EMBASE, MEDLINE and PsycINFO on Jan 1, 2017 to identify full-text articles with an aim of assessing...... the measurement properties of PROMs in PsA. Two independent reviewers rated the quality of studies using the COnsensus based standards for the Selection of health Measurement INstruments (COSMIN) checklist, and performed a qualitative evidence synthesis. Results: Fifty-five studies were included in the systematic...

  11. The impact of patient-reported outcome measures in clinical practice for pain: a systematic review.

    Science.gov (United States)

    Holmes, Michelle M; Lewith, George; Newell, David; Field, Jonathan; Bishop, Felicity L

    2017-02-01

    Patient-reported outcome measures (PROMs) have increasingly been incorporated into clinical practice. Research suggests that PROMs could be viewed as active components of complex interventions and may affect the process and outcome of care. This systematic review examines PROMs in the context of treatment for non-malignant pain. An electronic search on: MEDLINE, EMBASE, PsycINFO, PsycARTICLES, Cochrane Library and Web of Science identified relevant papers (February 2015). The inclusion criteria were: focused on implementing PROMs into clinical practice, adults, and primary data studies. Critical interpretive synthesis was used to synthesise qualitative and quantitative findings into a theoretical argument. Thirteen eligible studies were identified. Synthesis suggested that PROMs may be included in the initial consultation to assess patients and for shared decision-making regarding patient care. During the course of treatment, PROMs can be used to track progress, evaluate treatment, and change the course of care; using PROMs may also influence the therapeutic relationship. Post-treatment, using PROMs might directly influence other outcomes such as pain and patient satisfaction. However, although studies have investigated these areas, evidence is weak and inconclusive. Due to the poor quality, lack of generalisability and heterogeneity of these studies, it is not possible to provide a comprehensive understanding of how PROMs may impact clinical treatment of non-malignant pain. The literature suggests that PROMs enable pain assessment, decision-making, the therapeutic relationship, evaluation of treatment and may influence outcomes. Further research is needed to provide better evidence as to whether PROMs do indeed have any effects on these domains.

  12. Patient Reported Outcome Measure of Spiritual Care as Delivered by Chaplains.

    Science.gov (United States)

    Snowden, Austyn; Telfer, Iain

    2017-01-01

    Chaplains are employed by health organizations around the world to support patients in recognizing and addressing their spiritual needs. There is currently no generalizable measure of the impact of these interventions and so the clinical and strategic worth of chaplaincy is difficult to articulate. This article introduces the Scottish PROM, an original five-item patient reported outcome measure constructed specifically to address this gap. It describes the validation process from its conceptual grounding in the spiritual care literature through face and content validity cycles. It shows that the Scottish PROM is internally consistent and unidimensional. Responses to the Scottish PROM show strong convergent validity with responses to the Warwick and Edinburgh Mental Well-Being Scale, a generic well-being scale often used as a proxy for spiritual well-being. In summary, the Scottish PROM is fit for purpose. It measures the outcomes of spiritual care as delivered by chaplains in this study. This novel project introduces an essential and original breakthrough; the possibility of generalizable international chaplaincy research.

  13. The importance of patient-reported outcome measures in reconstructive urology.

    Science.gov (United States)

    Jackson, Matthew J; N'Dow, James; Pickard, Rob

    2010-11-01

    Patient-reported outcome measures (PROMs) are now recognised as the most appropriate instruments to assess the effectiveness of healthcare interventions from the patient's perspective. The purpose of this review was to identify recent publications describing the use of PROMs following reconstructive urological surgery. A wide systematic search identified only three original articles published in the last 2 years that prospectively assessed effectiveness using a patient-completed condition-specific or generic health-related quality of life (HRQoL) instrument. These publications illustrate the need to administer PROMs at a postoperative interval relevant to the anticipated recovery phase of individual procedures. They also highlight the difference in responsiveness of generic HRQoL instruments to symptomatic improvement between straightforward conditions such as pelviureteric junction obstruction and complex multidimensional conditions such as meningomyelocele. PROMs uptake and awareness is increasing in reconstructive urology but more work is required to demonstrate the effectiveness of surgical procedures for patients and healthcare funders alike. Healthcare policy-makers now rely on these measures to determine whether specific treatments are worth financing and to compare outcomes between institutions.

  14. Translating patient reported outcome measures: methodological issues explored using cognitive interviewing with three rheumatoid arthritis measures in six European languages

    NARCIS (Netherlands)

    Hewlett, Sarah E.; Nicklin, Joanna; Bode, Christina; Carmona, Loretto; Dures, Emma; Engelbrecht, Matthias; Hagel, Sofia; Kirwan, John R.; Molto, Anna; Redondo, Marta; Gossec, Laure

    2016-01-01

    Objective. Cross-cultural translation of patient-reported outcome measures (PROMs) is a lengthy process, often performed professionally. Cognitive interviewing assesses patient comprehension of PROMs. The objective was to evaluate the usefulness of cognitive interviewing to assess translations and

  15. What is the value of the routine use of patient-reported outcome measures toward improvement of patient outcomes, processes of care, and health service outcomes in cancer care? A systematic review of controlled trials.

    Science.gov (United States)

    Kotronoulas, Grigorios; Kearney, Nora; Maguire, Roma; Harrow, Alison; Di Domenico, David; Croy, Suzanne; MacGillivray, Stephen

    2014-05-10

    The systematic use of patient-reported outcome measures (PROMs) has been advocated as an effective way to standardize cancer practice. Yet, the question of whether PROMs can lead to actual improvements in the quality of patient care remains under debate. This review examined whether inclusion of PROM in routine clinical practice is associated with improvements in patient outcomes, processes of care, and health service outcomes during active anticancer treatment. A systematic review of five electronic databases (Medline, EMBASE, CINAHL [Cumulative Index to Nursing and Allied Health Literature], PsycINFO, and Psychology and Behavioral Sciences Collection [PBSC]) was conducted from database inception to May 2012 to locate randomized and nonrandomized controlled trials of patients receiving active anticancer treatment or supportive care irrespective of type of cancer. Based on prespecified eligibility criteria, we included 26 articles that reported on 24 unique controlled trials. Wide variability in the design and use of interventions delivered, outcomes evaluated, and cancer- and modality-specific context was apparent. Health service outcomes were only scarcely included as end points. Overall, the number of statistically significant findings were limited and PROMs' intervention effect sizes were predominantly small-to-moderate. The routine use of PROMs increases the frequency of discussion of patient outcomes during consultations. In some studies, PROMs are associated with improved symptom control, increased supportive care measures, and patient satisfaction. Additional effort is required to ensure patient adherence, as well as additional support to clinicians who will respond to patient concerns and issues, with clear system guidelines in place to guide their responses. More research is required to support PROM cost-benefit in terms of patient safety, clinician burden, and health services usage.

  16. Readability Level of Spanish-Language Patient-Reported Outcome Measures in Audiology and Otolaryngology

    Science.gov (United States)

    Coco, Laura; Colina, Sonia; Atcherson, Samuel R.

    2017-01-01

    Purpose The purpose of this study was to examine the readability level of the Spanish versions of several audiology- and otolaryngology-related patient-reported outcome measures (PROMs) and include a readability analysis of 2 translation approaches when available—the published version and a “functionalist” version—using a team-based collaborative approach including community members. Method Readability levels were calculated using the Fry Graph adapted for Spanish, as well as the Fernandez-Huerta and the Spaulding formulae for several commonly used audiology- and otolaryngology-related PROMs. Results Readability calculations agreed with previous studies analyzing audiology-related PROMs in English and demonstrated many Spanish-language PROMs were beyond the 5th grade reading level suggested for health-related materials written for the average population. In addition, the functionalist versions of the PROMs yielded lower grade-level (improved) readability levels than the published versions. Conclusion Our results suggest many of the Spanish-language PROMs evaluated here are beyond the recommended readability levels and may be influenced by the approach to translation. Moreover, improved readability may be possible using a functionalist approach to translation. Future analysis of the suitability of outcome measures and the quality of their translations should move beyond readability and include an evaluation of the individual's comprehension of the written text. PMID:28892821

  17. A systematic review of measurement properties of patient reported outcome measures in psoriatic arthritis: A GRAPPA-OMERACT initiative.

    Science.gov (United States)

    Højgaard, Pil; Klokker, Louise; Orbai, Ana-Maria; Holmsted, Kim; Bartels, Else M; Leung, Ying Ying; Goel, Niti; de Wit, Maarten; Gladman, Dafna D; Mease, Philip; Dreyer, Lene; Kristensen, Lars E; FitzGerald, Oliver; Tillett, William; Gossec, Laure; Helliwell, Philip; Strand, Vibeke; Ogdie, Alexis; Terwee, Caroline B; Christensen, Robin

    2018-04-01

    An updated psoriatic arthritis (PsA) core outcome set (COS) for randomized controlled trials (RCTs) was endorsed at the Outcome Measures in Rheumatology (OMERACT) meeting in 2016. To synthesize the evidence on measurement properties of patient reported outcome measures (PROMs) for PsA and thereby contribute to development of a PsA core outcome measurement set (COMS) as described by the OMERACT Filter 2.0. A systematic literature search was performed in EMBASE, MEDLINE and PsycINFO on Jan 1, 2017 to identify full-text articles with an aim of assessing the measurement properties of PROMs in PsA. Two independent reviewers rated the quality of studies using the COnsensus based standards for the Selection of health Measurement INstruments (COSMIN) checklist, and performed a qualitative evidence synthesis. Fifty-five studies were included in the systematic review. Forty-four instruments and a total of 89 scales were analyzed. PROMs measuring COS domains with at least fair quality evidence for good validity and reliability (and no evidence for poor properties) included the Stockerau Activity Score for PsA (German), Psoriasis Symptom Inventory, visual analogue scale for Patient Global, 36 Item Short Form Health Survey Physical Function subscale, Health Assessment Questionnaire Disability Index, Bath Ankylosing Spondylitis Functional Index, PsA Impact of Disease questionnaire, PsA Quality of Life questionnaire, VITACORA-19, Functional Assessment of Chronic Illness Therapy Fatigue scale and Social Role Participation Questionnaire. At least one PROM with some evidence for aspects of validity and reliability was available for six of the eight mandatory domains of the PsA COS. Copyright © 2018 Elsevier Inc. All rights reserved.

  18. PROM and Labour Effects on Urinary Metabolome: A Pilot Study

    Directory of Open Access Journals (Sweden)

    Alessandra Meloni

    2018-01-01

    Full Text Available Since pathologies and complications occurring during pregnancy and/or during labour may cause adverse outcomes for both newborns and mothers, there is a growing interest in metabolomic applications on pregnancy investigation. In fact, metabolomics has proved to be an efficient strategy for the description of several perinatal conditions. In particular, this study focuses on premature rupture of membranes (PROM in pregnancy at term. For this project, urine samples were collected at three different clinical conditions: out of labour before PROM occurrence (Ph1, out of labour with PROM (Ph2, and during labour with PROM (Ph3. GC-MS analysis, followed by univariate and multivariate statistical analysis, was able to discriminate among the different classes, highlighting the metabolites most involved in the discrimination.

  19. PROM and Labour Effects on Urinary Metabolome: A Pilot Study

    Science.gov (United States)

    Meloni, Alessandra; Palmas, Francesco; Mereu, Rossella; Deiana, Sara Francesca; Fais, Maria Francesca; Mussap, Michele; Ragusa, Antonio; Pintus, Roberta; Fanos, Vassilios; Melis, Gian Benedetto

    2018-01-01

    Since pathologies and complications occurring during pregnancy and/or during labour may cause adverse outcomes for both newborns and mothers, there is a growing interest in metabolomic applications on pregnancy investigation. In fact, metabolomics has proved to be an efficient strategy for the description of several perinatal conditions. In particular, this study focuses on premature rupture of membranes (PROM) in pregnancy at term. For this project, urine samples were collected at three different clinical conditions: out of labour before PROM occurrence (Ph1), out of labour with PROM (Ph2), and during labour with PROM (Ph3). GC-MS analysis, followed by univariate and multivariate statistical analysis, was able to discriminate among the different classes, highlighting the metabolites most involved in the discrimination. PMID:29511388

  20. Added Value of Patient-Reported Outcome Measures in Stroke Clinical Practice.

    Science.gov (United States)

    Katzan, Irene L; Thompson, Nicolas R; Lapin, Brittany; Uchino, Ken

    2017-07-21

    There is uncertainty regarding the clinical utility of the data obtained from patient-reported outcome measures (PROMs) for patient care. We evaluated the incremental information obtained by PROMs compared to the clinician-reported modified Rankin Scale (mRS). This was an observational study of 3283 ischemic stroke patients seen in a cerebrovascular clinic from September 14, 2012 to June 16, 2015 who completed the routinely collected PROMs: Stroke Impact Scale-16 (SIS-16), EQ-5D, Patient Health Questionnaire-9, PROMIS Physical Function, and PROMIS fatigue. The amount of variation in the PROMs explained by mRS was determined using r 2 after adjustment for age and level of stroke impairment. The proportion with meaningful change was calculated for patients with ≥2 visits. Concordance with change in the other scales and the ability to discriminate changes in health state as measured by c-statistic was evaluated for mRS versus SIS-16. Correlation between PROMs and mRS was highest for SIS-16 ( r =-0.64, P measures. PROMs provide additional valuable information compared to the mRS alone in stroke patients seen in the ambulatory setting. SIS-16 may have a better ability to identify change than mRS in health status of relevance to the patient. PROMs may be a useful addition to mRS in the assessment of health status in clinical practice. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

  1. [Dutch-language patient-reported outcome measures for foot and ankle injuries; a systematic review].

    Science.gov (United States)

    Weel, Hanneke; Zwiers, Ruben; Sierevelt, Inger N; Haverkamp, Daniel; van Dijk, C Niek; Kerkhoffs, Gino M M J

    2015-01-01

    To investigate which valid and reliable patient-reported outcome measures (PROMs) are available for foot and ankle disorders in the Dutch population, and which of these is the most suitable for uniform use. Systematic review. PubMed, Embase and Google Scholar were systematically searched for relevant articles; subsequently two researchers screened first the title and the abstract, and then the full article within a selection of these articles. Studies that described a validation process for foot- and ankle-PROMs in a Dutch population were included. Data on measurement characteristics and translation procedure were extracted, and methodological quality of the studies was assessed using the COSMIN checklist. ('COSMIN' stands for 'Consensus-based standards for the selection of health status measurement instruments'.) Two general foot- and ankle-PROMs in the Dutch language were validated: the Foot and Ankle Outcome Score (FAOS) and the Foot and Ankle Ability Measurement (FAAM); two foot-PROMs: the Manchester Foot Pain and Disability Index (MFPDI) and the 5-point Foot Function Index (FFI-5pt) were also validated. There were also two disorder-specific PROMs available in Dutch: the Victorian Institute of Sports Assessment-Achilles (VISA-A) for Achilles tendinopathies and the Foot Impact Scale for Rheumatoid Arthritis (FIS-RA) for rheumatoid arthritis patients. The FAOS and the FFI-5pt showed the strongest evidence for having good measurement characteristics. Currently, we regard the FAOS as the most appropriate foot- and ankle-PROM for general foot and ankle problems. Further studies of higher methodological quality are, however, required to draw firmer conclusions.

  2. Patient-reported outcome measures for patients with meniscal tears: a systematic review of measurement properties and evaluation with the COSMIN checklist

    Science.gov (United States)

    Middleton, Robert; Beard, David J; Price, Andrew J; Hopewell, Sally

    2017-01-01

    Objective Meniscal tears occur frequently in the population and the most common surgical treatment, arthroscopic partial meniscectomy, is performed in approximately two million cases worldwide each year. The purpose of this systematic review is to summarise and critically appraise the evidence for the use of patient-reported outcome measures (PROMs) in patients with meniscal tears. Design A systematic review was undertaken. Data on reported measurement properties were extracted and the quality of the studies appraised according to Consensus-based Standards for the Selection of Health Measurement Instruments. Data sources A search of MEDLINE, Embase, AMED and PsycINFO, unlimited by language or publication date (last search 20 February 2017). Eligibility criteria for selecting studies Development and validation studies reporting the measurement properties of PROMs in patients with meniscal tears were included. Results 11 studies and 10 PROMs were included. The overall quality of studies was poor. For measurement of symptoms and functional status, there is only very limited evidence supporting the selection of either the Lysholm Knee Scale, International Knee Documentation Committee Subjective Knee Form or the Dutch version of the Knee injury and Osteoarthritis Outcome Score. For measuring health-related quality of life, only limited evidence supports the selection of the Western Ontario Meniscal Evaluation Tool (WOMET). Of all the PROMs evaluated, WOMET has the strongest evidence for content validity. Conclusion For patients with meniscal tears, there is poor quality and incomplete evidence regarding the validity of the currently available PROMs. Further research is required to ensure these PROMs truly reflect the symptoms, function and quality of life of patients with meniscal tears. PROSPERO registration number CRD42017056847. PMID:29030413

  3. An independent psychometric evaluation of the PROMS measure of music perception skills

    NARCIS (Netherlands)

    Kunert, R.; Willems, R.M.; Hagoort, P.

    2016-01-01

    The Profile of Music Perception Skills (PROMS) is a recently developed measure of perceptual music skills which has been shown to have promising psychometric properties. In this paper we extend the evaluation of its brief version to three kinds of validity using an individual difference approach.

  4. Patient reported outcome measures in male incontinence surgery.

    Science.gov (United States)

    Tran, M G B; Yip, J; Uveili, K; Biers, S M; Thiruchelvam, N

    2014-10-01

    Patient reported outcome measures (PROMs) were used to evaluate outcomes of the artificial urinary sphincter (AUS) and the AdVance™ (American Medical Systems, Minnetonka, MN, US) male sling system (AVMS) for the symptomatic management of male stress urinary incontinence. All male patients with stress urinary incontinence referred to our specialist clinic over a two-year period completed the ICIQ-UI SF (International Consultation on Incontinence Questionnaire on Urinary Incontinence Short Form) and the ICIQ-MLUTS LF (International Consultation on Incontinence Questionnaire on Male Lower Urinary Tract Symptoms Long Form) at consultation as well as at subsequent follow-up appointments. The Wilcoxon signed-rank test for non-parametric paired data was used for pre and postoperative comparisons. The chi-squared test was used for categorical variables. Thirty-seven patients (forty surgical cases) completed a preoperative and at least one follow-up questionnaire. There was a statistically significant improvement in PROMs postoperatively, regardless of mode of surgery (p25) had greater improvement with an AUS than with the AVMS (p<0.01). This prospective study shows that completion and collection of PROMs as part of routine clinical practice is achievable and useful in the assessment of male stress incontinence surgery. PROMs are important instruments to assess effectiveness of healthcare intervention and they are useful adjuncts in surgical studies.

  5. Using patient reported outcome measures in health services: A qualitative study on including people with low literacy skills and learning disabilities

    NARCIS (Netherlands)

    Jahagirdar, D.; Kroll, T.; Ritchie, K.; Wyke, S.

    2012-01-01

    ABSTRACT: BACKGROUND: Patient reported outcome measures (PROMs) are self-report measures of health status increasingly promoted for use in healthcare quality improvement. However people with low literacy skills or learning disabilities may find PROMs hard to complete. Our study investigated

  6. Outcomes important to burns patients during scar management and how they compare to the concepts captured in burn-specific patient reported outcome measures.

    Science.gov (United States)

    Jones, Laura L; Calvert, Melanie; Moiemen, Naiem; Deeks, Jonathan J; Bishop, Jonathan; Kinghorn, Philip; Mathers, Jonathan

    2017-12-01

    Pressure garment therapy (PGT) is an established treatment for the prevention and treatment of hypertrophic scarring; however, there is limited evidence for its effectiveness. Burn survivors often experience multiple issues many of which are not adequately captured in current PGT trial measures. To assess the effectiveness of PGT it is important to understand what outcomes matter to patients and to consider whether patient-reported outcome measures (PROMs) can be used to ascertain the effect of treatments on patients' health-related quality of life. This study aimed to (a) understand the priorities and perspectives of adult burns patients and the parents of burns patients who have experienced PGT via in-depth qualitative data, and (b) compare these with the concepts captured within burn-specific PROMs. We undertook 40 semi-structured interviews with adults and parents of paediatric and adolescent burns patients who had experienced PGT to explore their priorities and perspectives on scar management. Interviews were audio-recorded, transcribed and thematically analysed. The outcomes interpreted within the interview data were then mapped against the concepts captured within burn-specific PROMs currently in the literature. Eight core outcome domains were identified as important to adult patients and parents: (1) scar characteristics and appearance, (2) movement and function, (3) scar sensation, (4) psychological distress, adjustments and a sense of normality, (5) body image and confidence, (6) engagement in activities, (7) impact on relationships, and (8) treatment burden. The outcome domains presented reflect a complex holistic patient experience of scar management and treatments such as PGT. Some currently available PROMs do capture the concepts described here, although none assess psychological adjustments and attainment of a sense of normality following burn injury. The routine use of PROMs that represent patient experience and their relative contribution to trial

  7. Toward Ensuring Health Equity: Readability and Cultural Equivalence of OMERACT Patient-reported Outcome Measures.

    Science.gov (United States)

    Petkovic, Jennifer; Epstein, Jonathan; Buchbinder, Rachelle; Welch, Vivian; Rader, Tamara; Lyddiatt, Anne; Clerehan, Rosemary; Christensen, Robin; Boonen, Annelies; Goel, Niti; Maxwell, Lara J; Toupin-April, Karine; De Wit, Maarten; Barton, Jennifer; Flurey, Caroline; Jull, Janet; Barnabe, Cheryl; Sreih, Antoine G; Campbell, Willemina; Pohl, Christoph; Duruöz, Mehmet Tuncay; Singh, Jasvinder A; Tugwell, Peter S; Guillemin, Francis

    2015-12-01

    The goal of the Outcome Measures in Rheumatology (OMERACT) 12 (2014) equity working group was to determine whether and how comprehensibility of patient-reported outcome measures (PROM) should be assessed, to ensure suitability for people with low literacy and differing cultures. The English, Dutch, French, and Turkish Health Assessment Questionnaires and English and French Osteoarthritis Knee and Hip Quality of Life questionnaires were evaluated by applying 3 readability formulas: Flesch Reading Ease, Flesch-Kincaid grade level, and Simple Measure of Gobbledygook; and a new tool, the Evaluative Linguistic Framework for Questionnaires, developed to assess text quality of questionnaires. We also considered a study assessing cross-cultural adaptation with/without back-translation and/or expert committee. The results of this preconference work were presented to the equity working group participants to gain their perspectives on the importance of comprehensibility and cross-cultural adaptation for PROM. Thirty-one OMERACT delegates attended the equity session. Twenty-six participants agreed that PROM should be assessed for comprehensibility and for use of suitable methods (4 abstained, 1 no). Twenty-two participants agreed that cultural equivalency of PROM should be assessed and suitable methods used (7 abstained, 2 no). Special interest group participants identified challenges with cross-cultural adaptation including resources required, and suggested patient involvement for improving translation and adaptation. Future work will include consensus exercises on what methods are required to ensure PROM are appropriate for people with low literacy and different cultures.

  8. Perspectives of patients and professionals on the use of patient reported outcome measures in primary care

    DEFF Research Database (Denmark)

    Porter, Ian; Gangannagaripalli, Jaheeda; Davey, Antoinette

    2017-01-01

    /or healthcare professional’s perspectives on the clinical utility of using PROMs in clinical practice. Results: 19 studies met the inclusion criteria (4 after 2012), 11 of which were conducted in the UK, reporting on the views of professionals (8), patients (5), and both (7). The majority of studies (12...... communication it was also noted that they undermined the human element of consultations, along with professional intuition and judgement. Burden on GP time was also noted. Conclusions: Patients and professionals highlighted a number of benefits of using PROMs in clinical practice, particularly in terms......A71 Perspectives of patients and professionals on the use of patient-reported outcome measures in primary care: a systematic review of qualitative studies Background: Although the use of patient-reported outcome measures (PROMs) in healthcare settings has increased substantially over recent years...

  9. Patient Satisfaction with Collection of Patient-Reported Outcome Measures in Routine Care.

    Science.gov (United States)

    Recinos, Pablo F; Dunphy, Cheryl J; Thompson, Nicolas; Schuschu, Jesse; Urchek, John L; Katzan, Irene L

    2017-02-01

    Systematic collection of patient-reported outcome measures (PROMs) during ambulatory clinic visits can enhance communication between patient and provider, and provide the ability to evaluate outcomes of care. Little is known about patient satisfaction of PROM data collection in routine clinical care. To evaluate patient reaction to the routine collection of PROMs in the ambulatory setting. Before all ambulatory clinic visits at our neurological institute, patients electronically complete health status questionnaires. We administered an 8-question patient satisfaction survey to a sample of patients seen across the institute after their clinical visit. Of 343 patients approached, 323 agreed to participate. The majority responded that the questionnaire system was easy to use, was an appropriate length, and benefited their care overall (strongly agree or agree = 92.3%, 87.6%, and 77.3%, respectively). Provider review of the PROMs with the patient during the clinic visit was associated with significantly higher positive responses to all questions, even those regarding logistical aspects of the collection process. There were significant age and race differences in response to perceived benefit: those in the Black/other race category had a markedly lower probability of viewing the process favorably with increasing age. Systematic collection of PROMs via an electronic questionnaire appears to be well accepted by patients. A minority of patients did not feel the questionnaire content applied to their appointment or that the system was a beneficial feature of the clinical practice. The provider can significantly improve the patient's perception of PROM collection and the patient-physician encounter by reviewing the questionnaire results with the patient.

  10. A Systematic Review of Measurement Properties of Patient-Reported Outcome Measures Used in Patients Undergoing Total Knee Arthroplasty.

    Science.gov (United States)

    Gagnier, Joel J; Mullins, Megan; Huang, Hsiaomin; Marinac-Dabic, Danica; Ghambaryan, Anna; Eloff, Benjamin; Mirza, Faisal; Bayona, Manuel

    2017-05-01

    While clinical research on total knee arthroplasty (TKA) outcomes is prevalent in the literature, studies often have poor methodological and reporting quality. A high-quality patient-reported outcome instrument is reliable, valid, and responsive. Many studies evaluate these properties, but none have done so with a systematic and accepted method. The objectives of this study were to identify patient-reported outcome measures (PROMs) for TKA, and to critically appraise, compare, and summarize their psychometric properties using accepted methods. MEDLINE, EMBASE, SCOPUS, Web of Science, PsycINFO, and SPORTDiscus were systematically searched for articles with the following inclusion criteria: publication before December 2014, English language, non-generic PRO, and evaluation in the TKA population. Methodological quality and evidence of psychometric properties were assessed with the COnsensus-based standards for the selection of health Status Measurement INstruments (COSMIN) checklist and criteria for psychometric evidence proposed by the COSMIN group and Terwee et al. One-hundred fifteen studies on 32 PROMs were included in this review. Only the Work, Osteoarthritis or joint-Replacement Questionnaire, the Oxford Knee Score, and the Western Ontario and McMaster Universities Arthritis Index had 4 or more properties with positive evidence. Most TKA PROMs have limited evidence for their psychometric properties. Although not all the properties were studied, the Work, Osteoarthritis or joint-Replacement Questionnaire, with the highest overall ratings, could be a useful PROM for evaluating patients undergoing TKA. The methods and reporting of this literature can improve by following accepted guidelines. Published by Elsevier Inc.

  11. Is it too early to move to full electronic PROM data collection?: A randomized controlled trial comparing PROM's after hallux valgus captured by e-mail, traditional mail and telephone.

    Science.gov (United States)

    Palmen, Leonieke N; Schrier, Joost C M; Scholten, Ruben; Jansen, Justus H W; Koëter, Sander

    2016-03-01

    Patient reported outcome measures (PROM's) after hallux valgus surgery are used to rate the effectiveness as perceived by the patient. The interpretability of these PROM's is highly dependent on participation rate. Data capture method may be an important factor contributing to the response rate. We investigated the effect on response rate of traditional paper mail, telephone and e-mail PROM's after hallux valgus surgery. All consecutive patients operated between January and September 2013, were identified. Included patients were randomized by envelope in three groups: traditional pen and paper mail, e-mail and telephone. They were asked to fill in a FFI and EQ-5D. Two weeks later non-responders were sent a reminder. Of the 73 included patients, 25 were approached by mail, 24 by e-mail and 24 patients by telephone. The response rate on traditional mail was highest (88%), while response on e-mail was lowest (33%). Response rate on telephone was also high (79%). Response rate on traditional mail and telephone was significantly higher (pmail. Though electronic data collection has enormous potential, this study shows that e-mail yields unacceptable low response rates. It is too early to replace traditional pen-and-paper PROM's by electronic questionnaires. Copyright © 2015 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved.

  12. Patient-Reported Outcome Measures for Use in Clinical Trials and Clinical Practice in Inflammatory Bowel Diseases: A Systematic Review.

    Science.gov (United States)

    de Jong, Marin J; Huibregtse, Roxanne; Masclee, Ad A M; Jonkers, Daisy M A E; Pierik, Marie J

    2018-05-01

    Mucosal inflammation must be carefully monitored to improve the long-term outcomes of patients with inflammatory bowel diseases (IBD). Patient-reported outcome measures (PROMs) are used increasingly to monitor disease activity in clinical practice and as endpoints in clinical trials. We performed a systematic review to provide an overview of the available PROMs on IBD activity and to evaluate their diagnostic value. A systematic search of the PubMed, Medline, Cochrane library, and Embase databases using defined keywords, identified 973 articles. These were screened by 2 independent reviewers, and 37 articles on development or validation of PROMs to assess IBD activity were identified for further analysis. Based on the recommendations of the Food and Drug Administration (FDA), the following measurement properties were evaluated: content, construct, and criterion validity; reliability; and responsiveness to change. In addition, data on ease of use in clinical practice were collected. Seventeen articles presenting 20 different PROMs were included the final analysis, although none met all the FDA-recommended criteria. Only 2 PROMs (patient-reported Harvey Bradshaw Index and Simple Clinical Colitis Activity Index scores) reported patient involvement during its development. Only 6 PROMs (patient-reported global assessment, patient assessment of disease activity, mobile health index for Crohn's disease, mobile health index for ulcerative colitis, patient-reported outcome derived from the Mayo score, and the 6-point Mayo score) were validated as markers of IBD activity, using findings from endoscopy as the reference standard; these PROMs identified patients with mucosal inflammation with area under the curve values of 0.63-0.82. The mobile health index for CD and UC scores had the best measurement properties for use in clinical practice and in clinical trials. In a systematic review, we identified more than 20 PROMS that have been developed and tested for their ability to

  13. The Role of Patient-Reported Outcome Measures in Value-Based Payment Reform.

    Science.gov (United States)

    Squitieri, Lee; Bozic, Kevin J; Pusic, Andrea L

    2017-06-01

    The U.S. health care system is currently experiencing profound change. Pressure to improve the quality of patient care and control costs have caused a rapid shift from traditional volume-driven fee-for-service reimbursement to value-based payment models. Under the 2015 Medicare Access and Children's Health Insurance Program Reauthorization Act, providers will be evaluated on the basis of quality and cost efficiency and ultimately receive adjusted reimbursement as per their performance. Although current performance metrics do not incorporate patient-reported outcome measures (PROMs), many wonder whether and how PROMs will eventually fit into value-based payment reform. On November 17, 2016, the second annual Patient-Reported Outcomes in Healthcare Conference brought together international stakeholders across all health care disciplines to discuss the potential role of PROs in value-based health care reform. The purpose of this article was to summarize the findings from this conference in the context of recent literature and guidelines to inform implementation of PROs in value-based payment models. Recommendations for evaluating key perspectives and measurement goals are made to facilitate appropriate use of PROMs to best benefit and amplify the voice of our patients. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  14. Readability of Orthopaedic Patient-reported Outcome Measures: Is There a Fundamental Failure to Communicate?

    Science.gov (United States)

    Perez, Jorge L; Mosher, Zachary A; Watson, Shawna L; Sheppard, Evan D; Brabston, Eugene W; McGwin, Gerald; Ponce, Brent A

    2017-08-01

    Patient-reported outcome measures (PROMs) are increasingly used to quantify patients' perceptions of functional ability. The American Medical Association and NIH suggest patient materials be written at or below 6th to 8th grade reading levels, respectively, yet one recent study asserts that few PROMs comply with these recommendations, and suggests that the majority of PROMs are written at too high of a reading level for self-administered patient use. Notably, this study was limited in its use of only one readability algorithm, although there is no commonly accepted, standard readability algorithm for healthcare-related materials. Our study, using multiple readability equations and heeding equal weight to each, hopes to yield a broader, all-encompassing estimate of readability, thereby offering a more accurate assessment of the readability of orthopaedic PROMS. (1) What proportion of orthopaedic-related PROMs and orthopaedic-related portions of the NIH Patient Reported Outcomes Measurement Information System (PROMIS ® ) are written at or below the 6th and 8th grade levels? (2) Is there a correlation between the number of questions in the PROM and reading level? (3) Using systematic edits based on guidelines from the Centers for Medicare and Medicaid Services, what proportion of PROMs achieved American Medical Association and NIH-recommended reading levels? Eighty-six (86) independent, orthopaedic and general wellness PROMs, drawn from commonly referenced orthopaedic websites and prior studies, were chosen for analysis. Additionally, owing to their increasing use in orthopaedics, four relevant short forms, and 11 adult, physical health question banks from the PROMIS ® , were included for analysis. All documents were analyzed for reading grade levels using 19 unique readability algorithms. Descriptive statistics were performed using SPSS Version 22.0. The majority of the independent PROMs (64 of 86; 74%) were written at or below the 6th grade level, with 81 of 86

  15. Systematic literature review of patient-reported outcome measures used in assessment and measurement of sleep disorders in chronic obstructive pulmonary disease.

    Science.gov (United States)

    Garrow, Adam P; Yorke, Janelle; Khan, Naimat; Vestbo, Jørgen; Singh, Dave; Tyson, Sarah

    2015-01-01

    Sleep problems are common in patients with chronic obstructive pulmonary disease (COPD), but the validity of patient-reported outcome measures (PROMs) that measure sleep dysfunction has not been evaluated. We have reviewed the literature to identify disease-specific and non-disease-specific sleep PROMs that have been validated for use in COPD patients. The review also examined the psychometric properties of identified sleep outcome measures and extracted point and variability estimates of sleep instruments used in COPD studies. The online EMBASE, MEDLINE, PsycINFO, and SCOPUS databases for all years to May 2014 were used to source articles for the review. The review was performed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Criteria from the Medical Outcomes Trust Scientific Advisory Committee guidelines were used to evaluate the psychometric properties of all sleep PROMs identified. One COPD-specific and six non-COPD-specific sleep outcome measures were identified and 44 papers met the review selection criteria. We only identified one instrument, the COPD and Asthma Sleep Impact Scale, which was developed specifically for use in COPD populations. Ninety percent of the identified studies used one of two non-disease-specific sleep scales, ie, the Pittsburgh Sleep Quality Index and/or the Epworth Sleep Scale, although neither has been tested for reliability or validity in people with COPD. The results highlight a need for existing non-disease-specific instruments to be validated in COPD populations and also a need for new disease-specific measures to assess the impact of sleep problems in COPD.

  16. Electronic capture of patient-reported and clinician-reported outcome measures in an elective orthopaedic setting: a retrospective cohort analysis.

    Science.gov (United States)

    Malhotra, Karan; Buraimoh, Olatunbosun; Thornton, James; Cullen, Nicholas; Singh, Dishan; Goldberg, Andrew J

    2016-06-20

    To determine whether an entirely electronic system can be used to capture both patient-reported outcomes (electronic Patient-Reported Outcome Measures, ePROMs) as well as clinician-validated diagnostic and complexity data in an elective surgical orthopaedic outpatient setting. To examine patients' experience of this system and factors impacting their experience. Retrospective analysis of prospectively collected data. Single centre series. Outpatient clinics at an elective foot and ankle unit in the UK. All new adult patients attending elective orthopaedic outpatient clinics over a 32-month period. All patients were invited to complete ePROMs prior to attending their outpatient appointment. At their appointment, those patients who had not completed ePROMs were offered the opportunity to complete it on a tablet device with technical support. Matched diagnostic and complexity data were captured by the treating consultant during the appointment. Capture rates of patient-reported and clinician-reported data. All information and technology (IT) failures, language and disability barriers were captured. Patients were asked to rate their experience of using ePROMs. The scoring systems used included EQ-5D-5L, the Manchester-Oxford Foot Questionnaire (MOxFQ) and the Visual Analogue Scale (VAS) pain score. Out of 2534 new patients, 2176 (85.9%) completed ePROMs, of whom 1090 (50.09%) completed ePROMs at home/work prior to their appointment. 31.5% used a mobile (smartphone/tablet) device. Clinician-reported data were captured on 2491 patients (98.3%). The mean patient experience score of using Patient-Reported Outcome Measures (PROMs) was 8.55±1.85 out of 10 and 666 patients (30.61%) left comments. Of patients leaving comments, 214 (32.13%) felt ePROMs did not adequately capture their symptoms and these patients had significantly lower patient experience scores (ptechnology into a service improvement programme. Excellent capture rates of ePROMs and clinician

  17. Assessing participation in the ACL injured population: Selecting a patient reported outcome measure on the basis of measurement properties.

    Science.gov (United States)

    Letchford, Robert; Sparkes, Valerie; van Deursen, Robert W M

    2015-06-01

    A return to pre injury activity participation remains a common but often elusive goal following ACL injury. Investigations to improve our understanding of participation restrictions are limited by inconsistent use of insufficiently investigated measurement tools. The aim of this study was to follow the consensus based standards for the selection of health measurement instruments (COSMIN) guideline to provide a comparative evaluation of four patient reported outcomes (PROMs) on the basis of measurement properties. This will inform recommendations for measuring participation of ACL injured subjects, particularly in the United Kingdom (UK) National Health Service (NHS). Thirteen criteria were compiled from the COSMIN guideline. These included reliability, measurement error, content validity, construct validity, responsiveness and interpretability. Data from 51 subjects collected as part of a longitudinal observational study of recovery over the first year following ACLR was used in the analysis. Of the thirteen criteria, the required standard was met in 11 for Tegner, 11 for International Knee Documentation Committee (IKDC), 6 for Cincinnati Sports Activity Scale (CSAS) and 6 for Marx. The two weaknesses identified for the Tegner are more easily compensated for during interpretation than those in the IKDC; for this reason the Tegner is the recommended PROM. The Tegner activity rating scale performed consistently well in respect of all measurement properties in this sample, with clear benefits over the other PROMs. The measurement properties presented should be used to inform implementation and interpretation of this outcome measure in clinical practice and research. Level II prospective study. Copyright © 2015 Elsevier B.V. All rights reserved.

  18. Patient-reported outcome measures for chronic obstructive pulmonary disease : the exclusion of people with low literacy skills and learning disabilities

    NARCIS (Netherlands)

    Jahagirdar, D.; Kroll, T.; Ritchie, K.; Wyke, S.

    2013-01-01

    BACKGROUND: Patient-reported outcome measures (PROMs) are intended to reflect outcomes relevant to patients. They are increasingly used for healthcare quality improvement. To produce valid measures, patients should be involved in the development process but it is unclear whether this usually

  19. Development and validation of a patient-reported outcome measure for stroke patients.

    Science.gov (United States)

    Luo, Yanhong; Yang, Jie; Zhang, Yanbo

    2015-05-08

    Family support and patient satisfaction with treatment are crucial for aiding in the recovery from stroke. However, current validated stroke-specific questionnaires may not adequately capture the impact of these two variables on patients undergoing clinical trials of new drugs. Therefore, the aim of this study was to develop and evaluate a new stroke patient-reported outcome measure (Stroke-PROM) instrument for capturing more comprehensive effects of stroke on patients participating in clinical trials of new drugs. A conceptual framework and a pool of items for the preliminary Stroke-PROM were generated by consulting the relevant literature and other questionnaires created in China and other countries, and interviewing 20 patients and 4 experts to ensure that all germane parameters were included. During the first item-selection phase, classical test theory and item response theory were applied to an initial scale completed by 133 patients with stroke. During the item-revaluation phase, classical test theory and item response theory were used again, this time with 475 patients with stroke and 104 healthy participants. During the scale assessment phase, confirmatory factor analysis was applied to the final scale of the Stroke-PROM using the same study population as in the second item-selection phase. Reliability, validity, responsiveness and feasibility of the final scale were tested. The final scale of Stroke-PROM contained 46 items describing four domains (physiology, psychology, society and treatment). These four domains were subdivided into 10 subdomains. Cronbach's α coefficients for the four domains ranged from 0.861 to 0.908. Confirmatory factor analysis supported the validity of the final scale, and the model fit index satisfied the criterion. Differences in the Stroke-PROM mean scores were significant between patients with stroke and healthy participants in nine subdomains (P < 0.001), indicating that the scale showed good responsiveness. The Stroke-PROM

  20. Measurement properties of patient-reported outcome measures (PROMS) in Patellofemoral Pain Syndrome: a systematic review.

    Science.gov (United States)

    Green, Andrew; Liles, Clive; Rushton, Alison; Kyte, Derek G

    2014-12-01

    This systematic review investigated the measurement properties of disease-specific patient-reported outcome measures used in Patellofemoral Pain Syndrome. Two independent reviewers conducted a systematic search of key databases (MEDLINE, EMBASE, AMED, CINHAL+ and the Cochrane Library from inception to August 2013) to identify relevant studies. A third reviewer mediated in the event of disagreement. Methodological quality was evaluated using the validated COSMIN (Consensus-based Standards for the Selection of Health Measurement Instruments) tool. Data synthesis across studies determined the level of evidence for each patient-reported outcome measure. The search strategy returned 2177 citations. Following the eligibility review phase, seven studies, evaluating twelve different patient-reported outcome measures, met inclusion criteria. A 'moderate' level of evidence supported the structural validity of several measures: the Flandry Questionnaire, Anterior Knee Pain Scale, Functional Index Questionnaire, Eng and Pierrynowski Questionnaire and Visual Analogue Scales for 'usual' and 'worst' pain. In addition, there was a 'Limited' level of evidence supporting the test-retest reliability and validity (cross-cultural, hypothesis testing) of the Persian version of the Anterior Knee Pain Scale. Other measurement properties were evaluated with poor methodological quality, and many properties were not evaluated in any of the included papers. Current disease-specific outcome measures for Patellofemoral Pain Syndrome require further investigation. Future studies should evaluate all important measurement properties, utilising an appropriate framework such as COSMIN to guide study design, to facilitate optimal methodological quality. Copyright © 2014 Elsevier Ltd. All rights reserved.

  1. Combining Clinical Information and Patient Reported Outcome Measures in Orthopaedic Surgery and Sports Medicine

    NARCIS (Netherlands)

    Kampen, D.A. van

    2013-01-01

    In this thesis we investigated the use of clinical information and Patient Reported Outcome Measures (PROMs) for patient evaluation in orthopaedic surgery and sports medicine. In the first part, we showed that the Dutch version of the Simple Shoulder Test (SST) is a valid and reliable

  2. Using patient reported outcome measures in health services: A qualitative study on including people with low literacy skills and learning disabilities

    Directory of Open Access Journals (Sweden)

    Jahagirdar Deepa

    2012-11-01

    Full Text Available Abstract Background Patient reported outcome measures (PROMs are self-report measures of health status increasingly promoted for use in healthcare quality improvement. However people with low literacy skills or learning disabilities may find PROMs hard to complete. Our study investigated stakeholder views on the accessibility and use of PROMs to develop suggestions for more inclusive practice. Methods Taking PROMs recommended for chronic obstructive pulmonary disease (COPD as an example, we conducted 8 interviews with people with low literacy skills and/or learning disabilities, and 4 focus groups with 20 health professionals and people with COPD. Discussions covered the format and delivery of PROMs using the EQ-5D and St George Respiratory Questionnaire as prompts. Thematic framework analysis focused on three main themes: Accessibility, Ease of Use, and Contextual factors. Results Accessibility included issues concerning the questionnaire format, and suggestions for improvement included larger font sizes and more white space. Ease of Use included discussion about PROMs’ administration. While health professionals suggested PROMs could be completed in waiting rooms, patients preferred settings with more privacy and where they could access help from people they know. Contextual Factors included other challenges and wider issues associated with completing PROMs. While health professionals highlighted difficulties created by the system in managing patients with low literacy/learning disabilities, patient participants stressed that understanding the purpose of PROMs was important to reduce intimidation. Conclusions Adjusting PROMs’ format, giving an explicit choice of where patients can complete them, and clearly conveying PROMs’ purpose and benefit to patients may help to prevent inequality when using PROMs in health services.

  3. A systematic review of generic multidimensional patient-reported outcome measures for children, part II: evaluation of psychometric performance of English-language versions in a general population.

    Science.gov (United States)

    Janssens, Astrid; Rogers, Morwenna; Thompson Coon, Jo; Allen, Karen; Green, Colin; Jenkinson, Crispin; Tennant, Alan; Logan, Stuart; Morris, Christopher

    2015-03-01

    The objectives of this systematic review were 1) to identify studies that assess the psychometric performance of the English-language version of 35 generic multidimensional patient-reported outcome measures (PROMs) for children and young people in general populations and evaluate their quality and 2) to summarize the psychometric properties of each PROM. MEDLINE, EMBASE, and PsycINFO were searched. The methodological quality of the articles was assessed using the COnsensus-based Standards for selection of health Measurement INstruments checklist. For each PROM, extracted evidence of content validity, construct validity, internal consistency, test-retest reliability, proxy reliability, responsiveness, and precision was judged against standardized reference criteria. We found no evidence for 14 PROMs. For the remaining 21 PROMs, 90 studies were identified. The methodological quality of most studies was fair. Quality was generally rated higher in more recent studies. Not reporting how missing data were handled was the most common reason for downgrading the quality. None of the 21 PROMs has had all psychometric properties evaluated; data on construct validity and internal consistency were most frequently reported. Overall, consistent positive findings for at least five psychometric properties were found for Child Health and Illness Profile, Healthy Pathways, KIDSCREEN, and Multi-dimensional Student Life Satisfaction Scale. None of the PROMs had been evaluated for responsiveness to detect change in general populations. Further well-designed studies with transparent reporting of methods and results are required. Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  4. The Cervical Dystonia Impact Profile (CDIP-58: Can a Rasch developed patient reported outcome measure satisfy traditional psychometric criteria?

    Directory of Open Access Journals (Sweden)

    Bhatia Kailash P

    2008-08-01

    Full Text Available Abstract Background The United States Food and Drug Administration (FDA are currently producing guidelines for the scientific adequacy of patient reported outcome measures (PROMs in clinical trials, which will have implications for the selection of scales used in future clinical trials. In this study, we examine how the Cervical Dystonia Impact Profile (CDIP-58, a rigorous Rasch measurement developed neurologic PROM, stands up to traditional psychometric criteria for three reasons: 1 provide traditional psychometric evidence for the CDIP-58 in line with proposed FDA guidelines; 2 enable researchers and clinicians to compare it with existing dystonia PROMs; and 3 help researchers and clinicians bridge the knowledge gap between old and new methods of reliability and validity testing. Methods We evaluated traditional psychometric properties of data quality, scaling assumptions, targeting, reliability and validity in a group of 391 people with CD. The main outcome measures used were the CDIP-58, Medical Outcome Study Short Form-36, the 28-item General Health Questionnaire, and Hospital and Anxiety and Depression Scale. Results A total of 391 people returned completed questionnaires (corrected response rate 87%. Analyses showed: 1 data quality was high (low missing data ≤ 4%, subscale scores could be computed for > 96% of the sample; 2 item groupings passed tests for scaling assumptions; 3 good targeting (except for the Sleep subscale, ceiling effect = 27%; 4 good reliability (Cronbach's alpha ≥ 0.92, test-retest intraclass correlations ≥ 0.83; and 5 validity was supported. Conclusion This study has shown that new psychometric methods can produce a PROM that stands up to traditional criteria and supports the clinical advantages of Rasch analysis.

  5. Development of a patient-reported outcome measure of recovery after abdominal surgery: a hypothesized conceptual framework.

    Science.gov (United States)

    Alam, Roshni; Figueiredo, Sabrina M; Balvardi, Saba; Nauche, Bénédicte; Landry, Tara; Lee, Lawrence; Mayo, Nancy E; Feldman, Liane S; Fiore, Julio F

    2018-05-17

    We initiated a research program to develop a novel patient-reported outcome measure (PROM) to assess postoperative recovery from the perspective of abdominal surgery patients. In light of FDA recommendations, the first stage of our program aimed to, based on previous literature and expert input, develop a hypothesized conceptual framework portraying the health domains that are potentially relevant to the process of recovery after abdominal surgery. This study was conducted in three phases: (1) systematic review to identify PROMs with measurement properties appraised in the context of recovery after abdominal surgery, (2) content analysis to categorize the health domains covered by the PROMs according to the ICF, and (3) two-round Delphi study to gain expert input regarding which of these health domains are relevant to the process of recovery. Participants were experts in perioperative care identified through two major surgical societies (35 invited). The systematic review identified 19 PROMs covering 66 ICF domains. 23 experts (66%) participated in the Delphi process. After Round 2, experts agreed that 22 health domains (8 body functions, 14 activities and participation) are potentially relevant to the process of recovery after abdominal surgery. These domains were organized into a diagram, representing our hypothesized conceptual framework. This hypothesized conceptual framework is an important first step in our research program and will be further refined based on in-depth qualitative interviews with patients. The sound methodological approach used to derive this framework may be valuable for studies aimed to develop PROMs according to FDA standards.

  6. A systematic review of patient-reported outcome measures in paediatric otolaryngology.

    Science.gov (United States)

    Powell, J; Powell, S; Robson, A

    2018-01-01

    Recently, there has been increased emphasis on the development and application of patient-reported outcome measures. This drive to assess the impact of illness or interventions, from the patient's perspective, has resulted in a greater number of available questionnaires. The importance of selecting an appropriate patient-reported outcome measure is specifically emphasised in the paediatric population. The literature on patient-reported outcome measures used in paediatric otolaryngology was reviewed. A comprehensive literature search was conducted using the databases Medline, Embase, Cumulative Index to Nursing and Allied Health Literature, and PsycInfo, using the terms: 'health assessment questionnaire', 'structured questionnaire', 'questionnaire', 'patient reported outcome measures', 'PROM', 'quality of life' or 'survey', and 'children' or 'otolaryngology'. The search was limited to English-language articles published between 1996 and 2016. The search yielded 656 articles, of which 63 were considered relevant. This included general paediatric patient-reported outcome measures applied to otolaryngology, and paediatric otolaryngology disease-specific patient-reported outcome measures. A large collection of patient-reported outcome measures are described in the paediatric otolaryngology literature. Greater standardisation of the patient-reported outcome measures used in paediatric otolaryngology would assist in pooling of data and increase the validation of tools used.

  7. What is the optimal time point to assess patient-reported recovery after hip and knee replacement? A systematic review and analysis of routinely reported outcome data from the English patient-reported outcome measures programme.

    Science.gov (United States)

    Browne, John Patrick; Bastaki, Hamad; Dawson, Jill

    2013-07-30

    It is unclear if there is a clinically important improvement in the six to 12-month recovery period after hip and knee replacement. This is an obvious gap in the evidence required by patients undergoing these procedures. It is also an issue for the English PROMs (Patient-Reported Outcome Measures) Programme which uses 6-month outcome data to compare the results of hospitals that perform hip and knee replacements. A systematic review of studies reporting the Oxford Hip Score (OHS) or Oxford Knee Score (OKS) at 12 months after surgery was performed. This was compared with six-month outcome data collected for 60, 160 patients within the English PROMs programme. A minimally important difference of one standard error of the measurement, equivalent to 2.7 for the OHS and 2.1 for the OKS, was adopted. Six studies reported OHS data for 10 different groups containing 8,308 patients in total. In eight groups the change scores reported were at least 2.7 points higher than the six-month change observed in the PROMs programme (20.2 points). Nine studies reported OKS data for 13 different groups containing 4,369 patients in total. In eight groups the change scores reported were at least 2.1 points higher than the six-month change observed in the PROMs programme (15.0 points). There is some evidence from this systematic review that clinically important improvement in the Oxford hip and knee scores occurs in the six to 12 month recovery period. This trend is more apparent for hip than knee replacement. Therefore we recommend that the English Department of Health study the impact on hospital comparisons of using 12- rather than six-month outcome data.

  8. Capturing and missing the patient's story through outcome measures: A thematic comparison of patient-generated items in PSYCHLOPS with CORE-OM and PHQ-9.

    Science.gov (United States)

    Sales, Célia Md; Neves, Inês Td; Alves, Paula G; Ashworth, Mark

    2017-11-22

    There is increasing interest in individualized patient-reported outcome measures (I-PROMS), where patients themselves indicate the specific problems they want to address in therapy and these problems are used as items within the outcome measurement tool. This paper examined the extent to which 279 items reported in an I-PROM (PSYCHLOPS) added qualitative information which was not captured by two well-established outcome measures (CORE-OM and PHQ-9). Comparison of items was only conducted for patients scoring above the "caseness" threshold on the standardized measures. 107 patients were participating in therapy within addiction and general psychiatric clinical settings. Almost every patient (95%) reported at least one item whose content was not covered by PHQ-9, and 71% reported at least one item not covered by CORE-OM. Results demonstrate the relevance of individualized outcome assessment for capturing data describing the issues of greatest concern to patients, as nomothetic measures do not always seem to capture the whole story. © 2017 The Authors Health Expectations Published by John Wiley & Sons Ltd.

  9. The Examination of Patient-Reported Outcomes and Postural Control Measures in Patients With and Without a History of ACL Reconstruction: A Case Control Study.

    Science.gov (United States)

    Hoch, Johanna M; Sinnott, Cori W; Robinson, Kendall P; Perkins, William O; Hartman, Jonathan W

    2018-03-01

    There is a lack of literature to support the diagnostic accuracy and cut-off scores of commonly used patient-reported outcome measures (PROMs) and clinician-oriented outcomes such as postural-control assessments (PCAs) when treating post-ACL reconstruction (ACLR) patients. These scores could help tailor treatments, enhance patient-centered care and may identify individuals in need of additional rehabilitation. To determine if differences in 4-PROMs and 3-PCAs exist between post-ACLR and healthy participants, and to determine the diagnostic accuracy and cut-off scores of these outcomes. Case control. Laboratory. A total of 20 post-ACLR and 40 healthy control participants. The participants completed 4-PROMs (the Disablement in the Physically Active Scale [DPA], The Fear-Avoidance Belief Questionnaire [FABQ], the Knee Osteoarthritis Outcomes Score [KOOS] subscales, and the Tampa Scale of Kinesiophobia [TSK-11]) and 3-PCAs (the Balance Error Scoring System [BESS], the modified Star Excursion Balance Test [SEBT], and static balance on an instrumented force plate). Mann-Whitney U tests examined differences between groups. Receiver operating characteristic (ROC) curves were employed to determine sensitivity and specificity. The Area Under the Curve (AUC) was calculated to determine the diagnostic accuracy of each instrument. The Youdin Index was used to determine cut-off scores. Alpha was set a priori at P < 0.05. There were significant differences between groups for all PROMs (P < 0.05). There were no differences in PCAs between groups. The cut-off scores should be interpreted with caution for some instruments, as the scores may not be clinically applicable. Post-ACLR participants have decreased self-reported function and health-related quality of life. The PROMs are capable of discriminating between groups. Clinicians should consider using the cut-off scores in clinical practice. Further use of the instruments to examine detriments after completion of standard

  10. Measurement properties of the most commonly used Foot- and Ankle-Specific Questionnaires: the FFI, FAOS and FAAM. A systematic review

    NARCIS (Netherlands)

    Sierevelt, I. N.; Zwiers, R.; Schats, W.; Haverkamp, D.; Terwee, C. B.; Nolte, P. A.; Kerkhoffs, G. M. M. J.

    2017-01-01

    In the foot and ankle literature, a wide range of patient-reported outcome measures (PROMs) is used, however, consensus as to which PROMs are preferred is lacking. Selection of a PROM is among other reasons, often based on measurement properties without considering the methodological quality of the

  11. C-REACTIVE PROTEIN IN PREMATURE RUPTURE OF MEMBRANE WITH RESPECT TO FETOMATERNAL OUTCOME

    Directory of Open Access Journals (Sweden)

    Ojaswini Patel

    2017-08-01

    Full Text Available BACKGROUND The incidence of PROM is about 10% of all pregnancies and 70% of them occur at term. Most of the Indian studies document an incidence of 7-12% for PROM of which 60-70% occurs at term. Rest of the 30-40% is contributed at preterm. The aim of the study is to study the usefulness of maternal CRP measurements in diagnosis of chorioamnionitis, puerperal endometritis, neonatal infectious morbidities and mortalities among patients with PROM ( both term and preterm. MATERIALS AND METHODS This is a hospital-based cross-sectional observational study where 100 premature rupture of membrane cases were diagnosed and observed for fetomaternal outcome by doing routine clinical, biochemical and serum CRP examinations. RESULTS Maximum number of chorioamnionitis (16% has developed when duration of rupture was for more than 36 hrs. PROM patients with latent period of ≥36 hrs had poorer neonatal outcome; i.e. 54.83% neonatal morbidity and 84.61% neonatal mortality were seen when duration of rupture was more than 36 hrs. 47.36% of CRP positive PROM women had developed chorioamnionitis during the course of delivery or postpartum. 49.12% of CRP positive PROM women had developed preterm delivery. CRP positive PROM women had poorer neonatal outcome; i.e. 82.35% neonatal morbidity and mortality has noted in babies delivered from CRP positive mother. CONCLUSION Careful antenatal monitoring, detection and prompt treatment of infection is necessary. Strict aseptic precautions, appropriate therapy, regular antenatal follow up are important features in the prevention and management of PROM. Evaluation of CRP in blood has helped to predict development of chorioamnionitis and preterm delivery following PROM and also perinatal morbidity and mortality.

  12. Feasibility test of a UK-scalable electronic system for regular collection of patient-reported outcome measures and linkage with clinical cancer registry data: The electronic Patient-reported Outcomes from Cancer Survivors (ePOCS system

    Directory of Open Access Journals (Sweden)

    Velikova Galina

    2011-10-01

    Full Text Available Abstract Background Cancer survivors can face significant physical and psychosocial challenges; there is a need to identify and predict which survivors experience what sorts of difficulties. As highlighted in the UK National Cancer Survivorship Initiative, routine post-diagnostic collection of patient reported outcome measures (PROMs is required; to be most informative, PROMs must be linked and analysed with patients' diagnostic and treatment information. We have designed and built a potentially cost-efficient UK-scalable electronic system for collecting PROMs via the internet, at regular post-diagnostic time-points, for linking these data with patients' clinical data in cancer registries, and for electronically managing the associated patient monitoring and communications; the electronic Patient-reported Outcomes from Cancer Survivors (ePOCS system. This study aims to test the feasibility of the ePOCS system, by running it for 2 years in two Yorkshire NHS Trusts, and using the Northern and Yorkshire Cancer Registry and Information Service. Methods/Design Non-metastatic breast, colorectal and prostate cancer patients (largest survivor groups, within 6 months post-diagnosis, will be recruited from hospitals in the Yorkshire Cancer Network. Participants will be asked to complete PROMS, assessing a range of health-related quality-of-life outcomes, at three time-points up to 15 months post-diagnosis, and subsequently to provide opinion on the ePOCS system via a feedback questionnaire. Feasibility will be examined primarily in terms of patient recruitment and retention rates, the representativeness of participating patients, the quantity and quality of collected PROMs data, patients' feedback, the success and reliability of the underpinning informatics, and the system running costs. If sufficient data are generated during system testing, these will be analysed to assess the health-related quality-of-life outcomes reported by patients, and to explore

  13. Development and Evaluation of an Implementation Strategy for Collecting Data in a National Registry and the Use of Patient-Reported Outcome Measures in Physical Therapist Practices: Quality Improvement Study.

    Science.gov (United States)

    Meerhoff, Guus A; van Dulmen, Simone A; Maas, Marjo J M; Heijblom, Karin; Nijhuis-van der Sanden, Maria W G; Van der Wees, Philip J

    2017-08-01

    In 2013, the Royal Dutch Society for Physical Therapy launched the program "Quality in Motion." This program aims to collect data from electronic health record systems in a registry that is fed back to physical therapists, facilitating quality improvement. The purpose of this study was to describe the development of an implementation strategy for the program and to evaluate the feasibility of building a registry and implementing patient-reported outcome measures (PROMs) in physical therapist practices. A stepwise approach using mixed methods was established in 3 consecutive pilots with 355 physical therapists from 66 practices. Interim results were evaluated using quantitative data from a self-assessment questionnaire and the registry and qualitative data from 21 semistructured interviews with physical therapists. Descriptive statistics and McNemar's symmetry chi-squared test were used to summarize the feasibility of implementing PROMs. PROMs were selected for the 5 most prevalent musculoskeletal conditions in Dutch physical therapist practices. A core component of the implementation strategy was the introduction of knowledge brokers to support physical therapists in establishing the routine use of PROMs in clinical practice and to assist in executing peer assessment workshops. In February 2013, 30.3% of the physical therapist practices delivered 4.4 completed treatment episodes per physical therapist to the registry; this increased to 92.4% in November 2014, delivering 54.1 completed patient episodes per physical therapist. Pre- and posttreatment PROM use increased from 12.2% to 39.5%. It is unclear if the participating physical therapists reflect a representative sample of Dutch therapists. Building a registry and implementing PROMs in physical therapist practices are feasible. The routine use of PROMs needs to increase to ensure valid feedback of outcomes. Using knowledge brokers is promising for implementing the program via peer assessment workshops. © 2017

  14. Measurement properties of the most commonly used Foot- and Ankle-Specific Questionnaires: the FFI, FAOS and FAAM. A systematic review.

    Science.gov (United States)

    Sierevelt, I N; Zwiers, R; Schats, W; Haverkamp, D; Terwee, C B; Nolte, P A; Kerkhoffs, G M M J

    2017-10-12

    In the foot and ankle literature, a wide range of patient-reported outcome measures (PROMs) is used, however, consensus as to which PROMs are preferred is lacking. Selection of a PROM is among other reasons, often based on measurement properties without considering the methodological quality of the studies that evaluate these measurement properties. The aim of current study was first to identify the most frequently used foot and ankle-specific PROMs in recent orthopaedic foot and ankle literature, and second to conduct a systematic review to synthesize and critically appraise the measurement properties of these PROMS. Six PubMed indexed journals focussing on foot and ankle research were screened to identify most commonly used foot and ankle-specific PROMs over a 2 year period (2015-2016). Subsequently, a systematic literature search was performed in PubMed, EMBASE, SPORTDiscus and Scopus to identify relevant studies on their measurement properties. Methodological quality assessment was performed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist, criteria for good measurement properties were applied, and a level of evidence was determined for the measurement properties of each domain of the questionnaires. The three most frequently reported PROMs were the Foot Function Index (FFI), the Foot and Ankle Outcome Score (FAOS) and the Foot and Ankle Activity Measure (FAAM). Among 2046 unique citations, 50 studies were included evaluating these PROMs. Evidence to support the measurement properties of the FFI was mainly lacking due to poor methodological quality. More evidence was available for the measurement properties of the FAOS and the FAAM, but overall evidence supporting all measurement properties is not yet sufficient. The best available evidence retrieved in this review showed that the FAOS and the FAAM are promising outcome measures for evaluation of patients with foot and ankle conditions, but their

  15. Patient-reported outcome measures for patients with cerebral aneurysms acquired via social media: data from a large nationwide sample.

    Science.gov (United States)

    Chen, Michael; Mangubat, Erwin; Ouyang, Bichun

    2016-01-01

    With greater survival rates, patient-reported outcome measures (PROMs) among survivors of ruptured cerebral aneurysm should be an increasing concern among neurointerventionalists. Prior studies were limited in scale and generalizability. Our study aims were to (1) evaluate the validity of cerebral aneurysm PROMs obtained from social media; (2) determine the persistence of PROMs over time; and (3) determine what PROMs still exist in those with no physical impairments. By engaging national brain aneurysm support groups and using an online questionnaire modeled after the generic EQ-5D instrument, we asked respondents to classify their health in five dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 3-point Likert scale. In 2 months we received 604 responses from 46 states in the USA. Our cohort of ruptured aneurysm respondents reported PROMs similar to previously published series. Over time, headache and anxiety improved while depression, level of exercise, and return to work remained unchanged. We found that memory worsened after 2 years. Among those without any physical impairment, rates of 20.6%, 14.9%, 12.6%, and 23% were seen for significant headaches, significant memory loss, significant depression, and sense of life being negatively affected, respectively. Despite this novel study design, we obtained results comparable to prior studies. These results suggest that many patients with ruptured cerebral aneurysms, regardless of whether they are >2 years after the event and/or free of physical impairment, struggle with a poor quality of life. The latency, scale, and low cost of this study design may accelerate future cerebral aneurysm PROM research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  16. Do Patient-Reported Outcome Measures describe functioning in patients with low back pain, using the Brief International Classification of Functioning, Disability and Health Core Set as a reference?

    DEFF Research Database (Denmark)

    Ibsen, Charlotte; Schiøttz-Christensen, Berit; Melchiorsen, Hanne

    2016-01-01

    OBJECTIVE: To link the items in the Patient-Reported Outcome Measures (PROMs): Roland Morris Disability Questionnaire, Short Form 36 (SF-36) and pain scores, to the Brief International Classification of Functioning, Disability and Health (ICF) Core Set for low back pain, and to examine the extent...... Set (34%). A weak correlation was found between the patients' responses and the clinician's assessment. CONCLUSION: The selected PROMs do not cover the prototypical spectrum of problems encountered in patients with low back pain as defined by the Brief ICF Core Set. The clinical assessment of patients...

  17. The Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (PROM) in Septorhinoplasty.

    Science.gov (United States)

    Spiekermann, Christoph; Amler, Susanne; Rudack, Claudia; Stenner, Markus

    2018-06-01

    The patient's satisfaction with the esthetic result is a major criterion of success in septorhinoplasty. However, the idea of esthetic perfection varies greatly and primarily depends on subjective perception. Hence, patient-reported instruments are important and necessary to assess the outcome in septorhinoplasty. To analyze the potential of the visual analog scale (VAS) as a patient-reported outcome measure in septorhinoplasty, the perception of the nasal appearance was assessed by a VAS pre- and postoperatively in 213 patients undergoing septorhinoplasty. Furthermore, in this prospective study, the patients' satisfaction concerning the procedure's result was analyzed using a five-point Likert scale. Females had lower preoperative VAS scores but a higher increase compared to males. Patients with lower initial VAS scores showed a higher improvement in the VAS score postoperatively compared to patients with higher initial VAS scores. Satisfaction with the result depends on the increase in the VAS score value. The VAS scale is a short and comprehensible tool to assess patients' perception of nasal appearance preoperatively and represents an appropriate instrument to assess the esthetic patient-reported outcome in septorhinoplasty.Level of Evidence IV This journal requires that authors assign a level of evidence to each article. For a full description of these evidence-based medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

  18. Results of total joint arthroplasty and joint preserving surgery in younger patients evaluated by alternative outcome measures

    DEFF Research Database (Denmark)

    Klit, Jakob

    2013-01-01

    The utilization of alternative outcome measures in the evaluation of outcome after PAO, TKA, and THA in young adults seem warranted to better understand the patients perception of successful treatment. Due to the lack of focus in contemporary literature on alternative aspects of outcome measurement...... in younger PAO, TKA, and THA patients our aims were, to explore patient satisfaction, fulfillment of expectations, symptoms of depression, the effect on socioeconomic status, and abilities in sex-life in younger PAO, TKA, and THA patients using PROMs. These alternative endpoints were collected in addition...... the surgeon and patient with information, when deciding the right time for surgery. 3. To investigate functional and quality of life aspects after PAO surgery in relation to the effect on the patient’s sex-life, the patient’s ability to participate in sports, the patient’s ability to interact socially...

  19. Development, content validity, and cross-cultural adaptation of a patient-reported outcome measure for real-time symptom assessment in irritable bowel syndrome.

    Science.gov (United States)

    Vork, L; Keszthelyi, D; Mujagic, Z; Kruimel, J W; Leue, C; Pontén, I; Törnblom, H; Simrén, M; Albu-Soda, A; Aziz, Q; Corsetti, M; Holvoet, L; Tack, J; Rao, S S; van Os, J; Quetglas, E G; Drossman, D A; Masclee, A A M

    2018-03-01

    End-of-day questionnaires, which are considered the gold standard for assessing abdominal pain and other gastrointestinal (GI) symptoms in irritable bowel syndrome (IBS), are influenced by recall and ecological bias. The experience sampling method (ESM) is characterized by random and repeated assessments in the natural state and environment of a subject, and herewith overcomes these limitations. This report describes the development of a patient-reported outcome measure (PROM) based on the ESM principle, taking into account content validity and cross-cultural adaptation. Focus group interviews with IBS patients and expert meetings with international experts in the fields of neurogastroenterology & motility and pain were performed in order to select the items for the PROM. Forward-and-back translation and cognitive interviews were performed to adapt the instrument for the use in different countries and to assure on patients' understanding with the final items. Focus group interviews revealed 42 items, categorized into five domains: physical status, defecation, mood and psychological factors, context and environment, and nutrition and drug use. Experts reduced the number of items to 32 and cognitive interviewing after translation resulted in a few slight adjustments regarding linguistic issues, but not regarding content of the items. An ESM-based PROM, suitable for momentary assessment of IBS symptom patterns was developed, taking into account content validity and cross-cultural adaptation. This PROM will be implemented in a specifically designed smartphone application and further validation in a multicenter setting will follow. © 2017 John Wiley & Sons Ltd.

  20. Inter-provider comparison of patient-reported outcomes: developing an adjustment to account for differences in patient case mix.

    Science.gov (United States)

    Nuttall, David; Parkin, David; Devlin, Nancy

    2015-01-01

    This paper describes the development of a methodology for the case-mix adjustment of patient-reported outcome measures (PROMs) data permitting the comparison of outcomes between providers on a like-for-like basis. Statistical models that take account of provider-specific effects form the basis of the proposed case-mix adjustment methodology. Indirect standardisation provides a transparent means of case mix adjusting the PROMs data, which are updated on a monthly basis. Recently published PROMs data for patients undergoing unilateral knee replacement are used to estimate empirical models and to demonstrate the application of the proposed case-mix adjustment methodology in practice. The results are illustrative and are used to highlight a number of theoretical and empirical issues that warrant further exploration. For example, because of differences between PROMs instruments, case-mix adjustment methodologies may require instrument-specific approaches. A number of key assumptions are made in estimating the empirical models, which could be open to challenge. The covariates of post-operative health status could be expanded, and alternative econometric methods could be employed. © 2013 Crown copyright.

  1. Raising the profile of pilot and feasibility studies in relation to the development, evaluation and implementation of patient-reported outcome measures.

    OpenAIRE

    Jones, GL

    2017-01-01

    This editorial introduces a new special series on the pilot and feasibility testing of patient-reported outcome measures (PROMs) in the on-line open access journal Pilot and Feasibility Studies. Pilot and feasibility studies are typically implemented to address issues of uncertainty before undertaking a larger definitive study such as a randomised controlled trial or large scale survey. This editorial considers the role that such pilot and feasibility testing plays in relation to the developm...

  2. Acute histologic chorioamnionitis is a risk factor for adverse neonatal outcome in late preterm birth after preterm premature rupture of membranes.

    Science.gov (United States)

    Lee, Seung Mi; Park, Jeong Woo; Kim, Byoung Jae; Park, Chan-Wook; Park, Joong Shin; Jun, Jong Kwan; Yoon, Bo Hyun

    2013-01-01

    The objective of this study was to determine whether acute histologic chorioamnionitis is associated with adverse neonatal outcomes in late preterm infants who were born after preterm PROM. The relationship between the presence of acute histologic chorioamnionitis and adverse neonatal outcome was examined in patients with preterm PROM who delivered singleton preterm newborns between 34 weeks and 36 6/7 weeks of gestation. Nonparametric statistics were used for data analysis. The frequency of acute histologic chorioamnionitis was 24% in patients with preterm PROM who delivered preterm newborns between 34 weeks and 36 6/7 weeks of gestation. Newborns born to mothers with histologic chorioamnionitis had significantly higher rates of adverse neonatal outcome (74% vs 51%; p<0.005) than those without histologic chorioamnionitis. This relationship remained significant after adjustment for gestational age at preterm PROM, gestational age at delivery, and exposure to antenatal corticosteroids. The presence of acute histologic chorioamnionitis is associated with adverse neonatal outcome in late preterm infants born to mothers with preterm PROM.

  3. Patient-reported outcomes and adult patients' disease experience in the idiopathic inflammatory myopathies. report from the OMERACT 11 Myositis Special Interest Group.

    Science.gov (United States)

    Alexanderson, Helene; Del Grande, Maria; Bingham, Clifton O; Orbai, Ana-Maria; Sarver, Catherine; Clegg-Smith, Katherine; Lundberg, Ingrid E; Song, Yeong Wook; Christopher-Stine, Lisa

    2014-03-01

    The newly formed Outcome Measures in Rheumatology (OMERACT) Myositis Special Interest Group (SIG) was established to examine patient-reported outcome measures (PROM) in myositis. At OMERACT 11, a literature review of PROM used in the idiopathic inflammatory myopathies (IIM) and other neuromuscular conditions was presented. The group examined in more detail 2 PROM more extensively evaluated in patients with IIM, the Myositis Activities Profile, and the McMaster-Toronto Arthritis Patient Preference Disability Questionnaire, through the OMERACT filter of truth, discrimination, and feasibility. Preliminary results from a qualitative study of patients with myositis regarding their symptoms were discussed that emphasized the range of symptoms experienced: pain, physical tightness/stiffness, fatigue, disease effect on emotional life and relationships, and treatment-related side effects. Following discussion of these results and following additional discussions since OMERACT 11, a research agenda was developed. The next step in evaluating PROM in IIM will require additional focus groups with a spectrum of patients with different myositis disease phenotypes and manifestations across a range of disease activity, and from multiple international settings. The group will initially focus on dermatomyositis and polymyositis in adults. Qualitative analysis will facilitate the identification of commonalities and divergent patient-relevant aspects of disease, insights that are critical given the heterogeneous manifestations of these diseases. Based on these qualitative studies, existing myositis PROM can be examined to more thoroughly assess content validity, and will be important to identify gaps in domain measurement that will be required to develop a preliminary core set of patient-relevant domains for IIM.

  4. Durable usage of patient-reported outcome measures in clinical practice to monitor health-related quality of life in head and neck cancer patients.

    Science.gov (United States)

    Duman-Lubberding, S; van Uden-Kraan, C F; Jansen, F; Witte, B I; Eerenstein, S E J; van Weert, S; de Bree, R; Leemans, C R; Verdonck-de Leeuw, I M

    2017-12-01

    To investigate the long-term follow-up (5 years) of implementing patient-reported outcome measures (PROMs) in clinical practice to monitor health-related quality of life (HRQOL) in head and neck cancer (HNC) patients. A mixed method design was used. The usage rate of OncoQuest (a touch screen computer system to monitor HRQOL) and the subsequent nurse consultation was calculated among HNC patients who visited the outpatient clinic for regular follow-up, as well as differences between ever users and never users (sociodemographic and clinical characteristics). The content of the nurse consultation was investigated. Reasons for not using (barriers) or using (facilitators) OncoQuest and the nurse consultation were explored from the perspective of HNC patients, and of head and neck surgeons. Usage rate of OncoQuest was 67% and of the nurse consultation 79%. Usage of OncoQuest was significantly related to tumor subsite and tumor stage. Topics most frequently (>40%) discussed during the nurse consultation were global quality of life (97%), head and neck cancer related symptoms (82%), other physical symptoms such as pain (61%), and psychological problems such as anxiety (44%). Several barriers and facilitators to implement PROMs in clinical practice were reported by both patients and head and neck surgeons. Usage of PROMs in clinical practice and a nurse consultation is durable, even 5 years after the introduction. This study contributes to better insight into long-term follow-up of implementation, thereby guiding future research and projects that aim to implement PROMs in clinical practice to monitor HRQOL among (head and neck) cancer patients.

  5. Should English healthcare providers be penalised for failing to collect patient-reported outcome measures? A retrospective analysis.

    Science.gov (United States)

    Gutacker, Nils; Street, Andrew; Gomes, Manuel; Bojke, Chris

    2015-08-01

    The best practice tariff for hip and knee replacement in the English National Health Service (NHS) rewards providers based on improvements in patient-reported outcome measures (PROMs) collected before and after surgery. Providers only receive a bonus if at least 50% of their patients complete the preoperative questionnaire. We determined how many providers failed to meet this threshold prior to the policy introduction and assessed longitudinal stability of participation rates. Retrospective observational study using data from Hospital Episode Statistics and the national PROM programme from April 2009 to March 2012. We calculated participation rates based on either (a) all PROM records or (b) only those that could be linked to inpatient records; constructed confidence intervals around rates to account for sampling variation; applied precision weighting to allow for volume; and applied risk adjustment. NHS hospitals and private providers in England. NHS patients undergoing elective unilateral hip and knee replacement surgery. Number of providers with participation rates statistically significantly below 50%. Crude rates identified many providers that failed to achieve the 50% threshold but there were substantially fewer after adjusting for uncertainty and precision. While important, risk adjustment required restricting the analysis to linked data. Year-on-year correlation between provider participation rates was moderate. Participation rates have improved over time and only a small number of providers now fall below the threshold, but administering preoperative questionnaires remains problematic in some providers. We recommend that participation rates are based on linked data and take into account sampling variation. © The Royal Society of Medicine.

  6. Patients' Experience of Myositis and Further Validation of a Myositis-specific Patient Reported Outcome Measure - Establishing Core Domains and Expanding Patient Input on Clinical Assessment in Myositis. Report from OMERACT 12.

    Science.gov (United States)

    Regardt, Malin; Basharat, Pari; Christopher-Stine, Lisa; Sarver, Catherine; Björn, Anita; Lundberg, Ingrid E; Wook Song, Yeong; Bingham, Clifton O; Alexanderson, Helene

    2015-12-01

    The Outcome Measures in Rheumatology (OMERACT) myositis working group was established to examine patient-reported outcomes (PRO) as well as to validate patient-reported outcome measures (PROM) in myositis. Qualitative studies using focus group interviews and cognitive debriefing of the myositis-specific Myositis Activities Profile (MAP) were used to explore the experience of adults living with polymyositis (PM) and dermatomyositis (DM). Preliminary results underscore the importance of patient input in the development of PROM to ensure content validity. Results from multicenter focus groups indicate the range of symptoms experienced including pain, fatigue, and impaired cognitive function, which are not currently assessed in myositis. Preliminary cognitive debriefing of the MAP indicated that while content was deemed relevant and important, several activities were not included; and that questionnaire construction and wording may benefit from revision. A research agenda was developed to continue work toward optimizing PRO assessment in myositis with 2 work streams. The first would continue to conduct and analyze focus groups until saturation in the thematic analysis was achieved to develop a framework that encompassed the patient-relevant aspects of myositis. The second would continue cognitive debriefing of the MAP to identify potential areas for revision. There was agreement that further work would be needed for inclusion body myositis and juvenile dermatomyositis, and that the inclusion of additional contributors such as caregivers and individuals from the pharmaceutical/regulatory spheres would be desirable. The currently used PROM do not assess symptoms or the effects of disease that are most important to patients; this emphasizes the necessity of patient involvement. Our work provides concrete examples for PRO identification.

  7. Acute histologic chorioamnionitis is a risk factor for adverse neonatal outcome in late preterm birth after preterm premature rupture of membranes.

    Directory of Open Access Journals (Sweden)

    Seung Mi Lee

    Full Text Available BACKGROUND: The objective of this study was to determine whether acute histologic chorioamnionitis is associated with adverse neonatal outcomes in late preterm infants who were born after preterm PROM. METHODOLOGY/PRINCIPAL FINDINGS: The relationship between the presence of acute histologic chorioamnionitis and adverse neonatal outcome was examined in patients with preterm PROM who delivered singleton preterm newborns between 34 weeks and 36 6/7 weeks of gestation. Nonparametric statistics were used for data analysis. The frequency of acute histologic chorioamnionitis was 24% in patients with preterm PROM who delivered preterm newborns between 34 weeks and 36 6/7 weeks of gestation. Newborns born to mothers with histologic chorioamnionitis had significantly higher rates of adverse neonatal outcome (74% vs 51%; p<0.005 than those without histologic chorioamnionitis. This relationship remained significant after adjustment for gestational age at preterm PROM, gestational age at delivery, and exposure to antenatal corticosteroids. CONCLUSIONS/SIGNIFICANCE: The presence of acute histologic chorioamnionitis is associated with adverse neonatal outcome in late preterm infants born to mothers with preterm PROM.

  8. Translation and Adaptation of the Genetic Counselling Outcome Scale (GCOS-24) for Use in Denmark

    DEFF Research Database (Denmark)

    Diness, Birgitte Rode; Overbeck, Gritt; Hjortshøj, Tina Duelund

    2017-01-01

    Outcome measurement in clinical genetics is challenging. Robust outcome measures are needed to provide evidence to support service development within genetic counseling. The Genetic Counselling Outcome Scale (GCOS-24), a Patient Reported Outcome Measure (PROM), was developed in English...... and validated with clinical genetics patients in the British NHS. This study reports the translation and adaptation of the GCOS-24 for use in Denmark. GCOS-24 was translated and back translated, supervised by an expert committee. Feedback on the first version was collected from genetic counseling patients...

  9. Gait analysis and functional outcome in patients after Lisfranc injury treatment.

    Science.gov (United States)

    van Hoeve, S; Stollenwerck, G; Willems, P; Witlox, M A; Meijer, K; Poeze, M

    2017-07-18

    Lisfranc injuries involve any bony or ligamentous disruption of the tarsometatarsal joint. Outcome results after treatment are mainly evaluated using patient-reported outcome measures (PROM), physical examination and radiographic findings. Less is known about the kinematics during gait. Nineteen patients (19 feet) treated for Lisfranc injury were recruited. Patients with conservative treatment and surgical treatment consisting of open reduction and internal fixation (ORIF) or primary arthrodesis were included. PROM, radiographic findings and gait analysis using the Oxford Foot Model (OFM) were analysed. Results were compared with twenty-one healthy subjects (31 feet). Multivariable logistic regression was used to determine factors influencing outcome. Patients treated for Lisfranc injury had a significantly lower walking speed than healthy subjects (Ppush-off phase (ppush-off phase (β=0.707, p=0.001), stability (β=0.423, p=0.028) and BMI (β=-0.727 p=push-off phase and fracture stability. Copyright © 2017. Published by Elsevier Ltd.

  10. Comparison between the Harris- and Oxford Hip Score to evaluate outcomes one-year after total hip arthroplasty

    NARCIS (Netherlands)

    Weel, Hanneke; Lindeboom, Robert; Kuipers, Sander E.; Vervest, Ton M. J. S.

    2017-01-01

    Harris Hip Score (HHS) is a surgeon administered measurement for assessing hip function before and after total hip arthroplasties (THA). Patient reported outcome measurements (PROMs) such as the Oxford Hip Score (OHS) are increasingly used. HHS was compaired to the OHS assessing whether the HHS can

  11. Self-report measures of prospective memory are reliable but not valid.

    Science.gov (United States)

    Uttl, Bob; Kibreab, Mekale

    2011-03-01

    Are self-report measures of prospective memory (ProM) reliable and valid? To examine this question, 240 undergraduate student volunteers completed several widely used self-report measures of ProM including the Prospective Memory Questionnaire (PMQ), the Prospective and Retrospective Memory Questionnaire (PRMQ), the Comprehensive Assessment of Prospective Memory (CAPM) questionnaire, self-reports of retrospective memory (RetM), objective measures of ProM and RetM, and measures of involvement in activities and events, memory strategies and aids use, personality and verbal intelligence. The results showed that both convergent and divergent validity of ProM self-reports are poor, even though we assessed ProM using a newly developed, reliable continuous measure. Further analyses showed that a substantial proportion of variability in ProM self-report scores was due to verbal intelligence, personality (conscientiousness, neuroticism), activities and event involvement (busyness), and use of memory strategies and aids. ProM self-reports have adequate reliability, but poor validity and should not be interpreted as reflecting ProM ability. (PsycINFO Database Record (c) 2011 APA, all rights reserved).

  12. Development of the measure of ovarian symptoms and treatment concerns: aiming for optimal measurement of patient-reported symptom benefit with chemotherapy for symptomatic ovarian cancer.

    Science.gov (United States)

    King, Madeleine T; Stockler, Martin R; Butow, Phyllis; O'Connell, Rachel; Voysey, Merryn; Oza, Amit M; Gillies, Kim; Donovan, Heidi S; Mercieca-Bebber, Rebecca; Martyn, Julie; Sjoquist, Katrin; Friedlander, Michael L

    2014-06-01

    The aim of this study was to determine the optimal patient-reported outcome measure (PROM) for assessing symptom benefit in trials of palliative chemotherapy for women with symptomatic ovarian cancer. Candidate PROMs were EORTC QLQ-C30 plus ovarian-specific QLQ-OV28, Functional Assessment of Cancer Therapy-Ovarian (FACT-O), FACT Ovarian Symptom Index (FOSI), and gynecologic cancer-specific Symptom Representation Questionnaire. Predefined optimality criteria were inclusion of all symptoms necessary for the specified purpose, recall period covering typical length of palliative chemotherapy, numerical item rating scales, and all necessary symptoms included in a single symptom index. Qualitative and quantitative methods were applied to data from stage 1 of the Gynecologic Cancer Intergroup Symptom Benefit Study to determine the set of necessary symptoms and to objectively assess candidate PROMs against the optimality criteria. Ten necessary symptoms were identified: pain, fatigue, abdominal bloating/discomfort, sleep disturbance, bowel disturbance, nausea and vomiting, shortness of breath, poor appetite, urinary symptoms, and weight changes. Although QLQ-C30 and QLQ-OV28 together cover all these symptoms, they split them into numerous scales, dissipating potential symptom-benefit signal. Conversely, FACT-O does not cover all necessary symptoms and contains many other HRQoL-related items and treatment side effects, diluting potential symptom-benefit signal when summed into scales. Item response scales and composite scoring of all candidate PROMs were suboptimal to our specific purpose. We therefore developed a new PROM, the Measure of Ovarian Symptoms and Treatment (MOST) concerns, to provide optimal measurement for the specified purpose. This article documents the development of the MOST, a new PROM designed to assess patient-reported benefits and burden as end points in clinical trials of palliative chemotherapy for women with symptomatic ovarian cancer. The validity

  13. Amnioinfusion in preterm PROM: effects on amnion and cord histology.

    Science.gov (United States)

    Locatelli, A; Andreani, M; Ghidini, A; Verderio, M; Pizzardi, A; Vergani, P; Salafia, C M

    2008-02-01

    To investigate the effects of transabdominal amnioinfusion (TA) on the histology of amnion (A) and umbilical cord (UC). From a cohort of 56 singleton pregnancies with premature rupture of membranes (PROM) at PROM of 18.7 weeks and at delivery of 26.1 weeks, with a latency of 50 days. Compared with subjects who declined the procedure, TA had a beneficial effect on clinical variables, mediated primarily by a longer latency. TA was not associated with identifiable effects on the histologic features of A or UC. A and UC histology is not significantly affected by exposure to saline solution even for prolonged periods of time.

  14. Protocols for Multimedia Systems : 6th International Conference, PROMS 2001 Enschede, The Netherlands, October 17–19, 2001 Proceedings

    NARCIS (Netherlands)

    van Sinderen, Marten J.; Nieuwenhuis, Lambert J.M.

    2001-01-01

    The goal of the PROMS series of conferences and workshops is to contribute to scientific, strategic, and practical cooperation between research institutes and industrial companies in the area of multimedia protocols. This is also the goal of PROMS 2001. The basic theme of this conference continues

  15. Is the surgical outcome for lumbar disc herniation related to the duration of symptoms?

    DEFF Research Database (Denmark)

    Støttrup, Christian; Ernst, Carsten; Clemmensen, Dorte

    included in a Single-Center Study. Data were prospectively collected in DaneSpine, the Danish National Spine Register. The patient reported outcome measures (PROM) EQ5D, SF36, ODI, VAS-leg and -back were correlated with duration of symptoms. Findings / Results: 832 patients were included in the study...

  16. Outcomes of preterm premature rupture of membranes in twin pregnancies.

    Science.gov (United States)

    Trentacoste, Stephanie V; Jean-Pierre, Claudel; Baergen, Rebecca; Chasen, Stephen T

    2008-08-01

    To describe outcomes in twin pregnancies with preterm premature rupture of membranes (PPROM). Dichorionic twin pregnancies complicated by PPROM at premature rupture of membranes (PROM), latency from PROM to delivery, and infection were examined. In 49 twin pregnancies, the median gestational age at PROM was 31 weeks with a median latency between PROM and delivery of 0 days (interquartile range 0-6). Latency intervals of >or=2 and >or=7 days were achieved by 40.8% and 22.4%, respectively. PPROM at or= 2 days (70.6% vs. 25.0%) and >or=7 days (47.1% vs. 9.4%). There was a significant relationship between latency and clinical and histologic signs of infection. After 30 weeks, most twin pregnancies with PPROM delivered within 2 days. Infection appears to be a consequence rather than a cause of PPROM in most cases.

  17. Promõshlennõje zonõ ohvatil "mjortvõi sezon" / Ain Alvela

    Index Scriptorium Estoniae

    Alvela, Ain, 1967-

    2008-01-01

    Arendajad on tehnoparkide rajamise ooterežiimile pannud - ostjaid jaguks, kuid võimalusi napib. Diagramm: Za pjat let stoimost zemli promõshlennogo naznatshenija võrosla v pjat raz; Tabel: Naiboleje dorogaja zemlja - v promparke Lasnamäe. Kommenteerivad Enn Tosso, Nikolai Pitshugov ja Urmas Ahven

  18. Psychometric validation of the Spanish version of the USS-PROM questionnaire for patients who undergo anterior urethral surgery.

    Science.gov (United States)

    Puche-Sanz, I; Martín-Way, D; Flores-Martín, J; Expósito-Ruiz, M; Vicente-Prados, J; Nogueras-Ocaña, M; Tinaut-Ranera, J; Cózar-Olmo, J M

    2016-06-01

    To translate into Spanish and validate the Urethral Stricture Surgery Patient-Reported Outcome Measure (USS-PROM) questionnaire, assessing its psychometric properties and determining its suitability for clinical use in our community. We also assessed the potential changes in ejaculatory function using the Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD). A systematic translation of the British version was performed. Patients scheduled for anterior urethral stricture surgery between September 2014 and September 2015 were prospectively included in the study. All patients completed the questionnaire before and after the surgery. We conducted an in-depth psychometric study of the questionnaire. We assessed the responses of a total of 40 patients. The questionnaire showed its validity, presenting an excellent negative correlation between the voiding symptom scores and the maximum flow (r=-0.6, P<.001), and also showed significant improvement in the EQ5D-VAS (visual analogue scale) and the time trade-off. For internal consistency, the Cronbach's alpha was 0.701. For the test-retest reliability, the overall intraclass correlation coefficient (ICC) was 0.974, and the ICC for each item separately ranged from 0.799 to 0.980. We observed significant improvement in all items regarding urinary symptoms and health-related quality of life (P<.001), thereby demonstrating the response capacity to changing the questionnaire. There were no significant changes in the MSHQ-EjD. The Spanish version of the USS-PROM questionnaire is a valid instrument for quantifying changes in voiding symptoms and the health-related quality of life of patients undergoing anterior urethral surgery. Copyright © 2016 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

  19. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Patient-Reported Outcomes in an Enhanced Recovery Pathway.

    Science.gov (United States)

    Abola, Ramon E; Bennett-Guerrero, Elliott; Kent, Michael L; Feldman, Liane S; Fiore, Julio F; Shaw, Andrew D; Thacker, Julie K M; Gan, Tong J; Miller, Timothy E; Hedrick, Traci L; McEvoy, Matthew D; Mythen, Michael G; Bergamaschi, Roberto; Gupta, Ruchir; Holubar, Stefan D; Senagore, Anthony J; Wischmeyer, Paul E; Carli, Franco; Evans, David C; Guilbert, Sarah; Kozar, Rosemary; Pryor, Aurora; Thiele, Robert H; Everett, Sotiria; Grocott, Mike

    2017-12-29

    Patient-reported outcomes (PROs) are measures of health status that come directly from the patient. PROs are an underutilized tool in the perioperative setting. Enhanced recovery pathways (ERPs) have primarily focused on traditional measures of health care quality such as complications and hospital length of stay. These measures do not capture postdischarge outcomes that are meaningful to patients such as function or freedom from disability. PROs can be used to facilitate shared decisions between patients and providers before surgery and establish benchmark recovery goals after surgery. PROs can also be utilized in quality improvement initiatives and clinical research studies. An expert panel, the Perioperative Quality Initiative (POQI) workgroup, conducted an extensive literature review to determine best practices for the incorporation of PROs in an ERP. This international group of experienced clinicians from North America and Europe met at Stony Brook, NY, on December 2-3, 2016, to review the evidence supporting the use of PROs in the context of surgical recovery. A modified Delphi method was used to capture the collective expertise of a diverse group to answer clinical questions. During 3 plenary sessions, the POQI PRO subgroup presented clinical questions based on a literature review, presented evidenced-based answers to those questions, and developed recommendations which represented a consensus opinion regarding the use of PROs in the context of an ERP. The POQI workgroup identified key criteria to evaluate patient-reported outcome measures (PROMs) for their incorporation in an ERP. The POQI workgroup agreed on the following recommendations: (1) PROMs in the perioperative setting should be collected in the framework of physical, mental, and social domains. (2) These data should be collected preoperatively at baseline, during the immediate postoperative time period, and after hospital discharge. (3) In the immediate postoperative setting, we recommend using

  20. LABOUR TERMINATION AND PERINATAL OUTCOME IN PREGNANT WOMEN WITH PLACENTA ABRUPTION WITH PPROM AND PROM

    Directory of Open Access Journals (Sweden)

    Ranko Kutlesic

    2007-10-01

    Full Text Available Placenta abruption is an obstetric accident which endangers life and health of both mother and embryo. It is one of the most serious obstetric complications, whose incidence ranges from 4.9-12.9 per 1,000 labours, and according to frequency, it represents the second cause of perinatal death. Retrospective analysis included the interval from 1996 to 2005. Total number of labours was analyzed and it was 32358. In addition, the number of labours complicated by placenta abruption was analyzed, and it was 119 or 0.37%. It analyzed the incidence of placenta abruption according to age of pregnancy and the integrity of embryonic membranes. It is established that there is no statistically significant difference in the incidence of placenta abruption appearing in pregnant women, with and without the disruption of embryonic membranes. The age of pregnant women was also analyzed, and it was found out that the pregnant women with placenta abruption and PPROM were 5 years older than those with placenta abruption without PPROM, and that this difference was very significant. Disruption duration was analyzed as well as the time from the first uterus bleeding to labour. The difference between PPROM and PROM duration was statistically significant, as well as the difference in duration between spontaneous and artificial rupture of embryonic membranes. The way of labour termination was analyzed in pregnant women with verified placenta abruption. In 80% of pregnant women, the labour was terminated by Caesarian section, and only 20% by vaginal labour. Also, the perinatal outcome was analyzed, according to Apgar score in the first and fifth minute. Apgar score showed that out of the total number of abruptions, 7 neonatuses was born dead (11.66%, 13 (21.66% was born in good condition (Apgar score>7, 26 (43.33% was marked with 4-7, while 14 (23.33% was in hard asphyxia (Apgar score 1-5.

  1. Towards Tailored Patient’s Management Approach: Integrating the Modified 2010 ACR Criteria for Fibromyalgia in Multidimensional Patient Reported Outcome Measures Questionnaire

    Directory of Open Access Journals (Sweden)

    Yasser El Miedany

    2016-01-01

    Full Text Available Objectives. To assess the validity, reliability, and responsiveness to change of a patient self-reported questionnaire combining the Widespread Pain Index and the Symptom Severity Score as well as construct outcome measures and comorbidities assessment in fibromyalgia patients. Methods. The PROMs-FM was conceptualized based on frameworks used by the WHO Quality of Life tool and the PROMIS. Initially, cognitive interviews were conducted to identify item pool of questions. Item selection and reduction were achieved based on patients as well as an interdisciplinary group of specialists. Rasch and internal consistency reliability analyses were implemented. The questionnaire included the modified ACR criteria main items (Symptom Severity Score and Widespread Pain Index, in addition to assessment of functional disability, quality of life (QoL, review of the systems, and comorbidities. Every patient completed HAQ and EQ-5D questionnaires. Results. A total of 146 fibromyalgia patients completed the questionnaire. The PROMs-FM questionnaire was reliable as demonstrated by a high standardized alpha (0.886–0.982. Content construct assessment of the functional disability and QoL revealed significant correlation (p<0.01 with both HAQ and EQ-5D. Changes in functional disability and QoL showed significant (p<0.01 variation with diseases activity status in response to therapy. There was higher prevalence of autonomic symptoms, CVS risk, sexual dysfunction, and falling. Conclusions. The developed PROMs-FM questionnaire is a reliable and valid instrument for assessment of fibromyalgia patients. A phased treatment regimen depending on the severity of FMS as well as preferences and comorbidities of the patient is the best approach to tailored patient management.

  2. Outcomes of different bearings in total hip arthroplasty - implant survival, revision causes, and patient-reported outcome

    DEFF Research Database (Denmark)

    Varnum, Claus

    2017-01-01

    ceramic-on-ceramic (CoC) THAs comparing them to those of "standard" metal-on-polyethylene (MoP) THAs. Study II: To compare the six-year revision risk for metal-on-metal (MoM) with that for MoP bearings in cementless stemmed THA, and further to study the revision risk for different designs of stemmed Mo...... for the outcome of THA is the type of bearings. This PhD thesis focuses on the influence of different types of bearings on implant survival, revision causes, PROMs, and noises from THA. The aims of the thesis were: Study I: To examine the revision risk and to investigate the causes of revision of cementless......M THAs and the causes of revision. Study III: To examine the association between CoC, MoM, and MoP bearings and both generic and disease-specific PROMs, and furthermore to examine the incidence and types of noises from the three types of bearings and identify the effect of noises on PROM scores. In study...

  3. The broad-host-range plasmid pSFA231 isolated from petroleum-contaminated sediment represents a new member of the PromA plasmid family.

    Science.gov (United States)

    Li, Xiaobin; Top, Eva M; Wang, Yafei; Brown, Celeste J; Yao, Fei; Yang, Shan; Jiang, Yong; Li, Hui

    2014-01-01

    A self-transmissible broad-host-range (BHR) plasmid pSFA231 was isolated from petroleum-contaminated sediment in Shen-fu wastewater irrigation zone, China, using the triparental mating exogenous plasmid capture method. Based on its complete sequence the plasmid has a size of 41.5 kb and codes for 50 putative open reading frames (orfs), 29 of which represent genes involved in replication, partitioning and transfer functions of the plasmid. Phylogenetic analysis grouped pSFA231 into the newly defined PromA plasmid family, which currently includes five members. Further comparative genomic analysis shows that pSFA231 shares the common backbone regions with the other PromA plasmids, i.e., genes involved in replication, maintenance and control, and conjugative transfer. Nevertheless, phylogenetic divergence was found in specific gene products. We propose to divide the PromA group into two subgroups, PromA-α (pMRAD02, pSB102) and PromA-β (pMOL98, pIPO2T, pSFA231, pTer331), based on the splits network analysis of the RepA protein. Interestingly, a cluster of hypothetical orfs located between parA and traA of pSFA231 shows high similarity with the corresponding regions on pMOL98, pIPO2T, and pTer331, suggesting these hypothetical orfs may represent "essential" plasmid backbone genes for the PromA-β subgroup. Alternatively, they may also be accessory genes that were first acquired and then stayed as the plasmid diverged. Our study increases the available collection of complete genome sequences of BHR plasmids, and since pSFA231 is the only characterized PromA plasmid from China, our findings also enhance our understanding of the genetic diversity of this plasmid group in different parts of the world.

  4. The broad-host-range plasmid pSFA231 isolated from petroleum-contaminated sediment represents a new member of the PromA plasmid family

    Directory of Open Access Journals (Sweden)

    Xiaobin eLi

    2015-01-01

    Full Text Available A self-transmissible broad-host-range (BHR plasmid pSFA231 was isolated from petroleum-contaminated sediment in Shen-fu wastewater irrigation zone, China, using the triparental mating exogenous plasmid capture method. Based on its complete sequence the plasmid has a size of 41.5 kb and codes for 50 putative open reading frames (orfs, 28 of which represent genes involved in replication, partitioning and transfer functions of the plasmid. Phylogenetic analysis grouped pSFA231 into the newly defined PromA plasmid family, which currently includes five members. Further comparative genomic analysis shows that pSFA231 shares the common backbone regions with the other PromA plasmids, i.e., genes involved in replication, maintenance and control, and conjugative transfer. Nevertheless, phylogenetic divergence was found in specific gene products. We propose to divide the PromA group into two subgroups, PromA-α (pMRAD02, pSB102 and PromA-β (pMOL98, pIPO2T, pSFA231, pTer331, based on the splits network analysis of the RepA protein. Interestingly, a cluster of hypothetical orfs located between parA and traA of pSFA231 shows high similarity with the corresponding regions on pMOL98, pIPO2T and pTer331, suggesting these hypothetical orfs may represent ‘‘essential’’ plasmid backbone genes for the PromA-β subgroup. Alternatively, they may also be accessory genes that were first acquired and then stayed as the plasmid diverged. Our study increases the available collection of complete genome sequences of BHR plasmids, and since pSFA231 is the only characterized PromA plasmid from China, our findings also enhance our understanding of the genetic diversity of this plasmid group in different parts of the world.

  5. Dimensionality of the Knee Numeric-Entity Evaluation Score (KNEES-ACL)

    DEFF Research Database (Denmark)

    Comins, J D; Krogsgaard, M R; Kreiner, Svend

    2013-01-01

    The benefit of anterior cruciate ligament (ACL) reconstruction has been questioned based on patient-reported outcome measures (PROMs). Valid interpretation of such results requires confirmation of the psychometric properties of the PROM. Rasch analysis is the gold standard for validation of PROMs...

  6. A PROSPECTIVE STUDY OF FOETOMATERNAL OUTCOME OF THE PATIENT WITH PREMATURE RUPTURE OF MEMBRANES

    Directory of Open Access Journals (Sweden)

    Satyaveer Singh

    2017-12-01

    Full Text Available BACKGROUND Before onset of labour, rupture of membrane is known as Premature rupture of membrane (PROM. PROM is one of the most common complications of pregnancy that has major impact on foetal and maternal outcomes. The aim of the present study was to evaluate the foetomaternal outcome of the patient with premature rupture of membranes, in Department of Obstetrics and Gynaecology, Umaid Hospital, Dr. Sampuranand Medical College, Jodhpur, Rajasthan, India. MATERIALS AND METHODS Randomly 100 cases were studied out during six months of period from Jan. 2016 to June 2016. RESULTS Out of 100 cases it was observed that the mean age of PROM patients was 25 ± 2.59 years with higher incidence in unbooked cases of hospital. Gestational age from 24 weeks to 42 weeks of pregnancy were included in the study. The mode of delivery in 73 patients was vaginal and 27 delivered by LSCS. The implicated risk was found i.e. anaemia (22, UTI (14, lower genital tract infection (8, Cervical stitched (1, malpresentation (5, twin (2 and 48 cases were without any risk factor. CONCLUSION Evaluation of risks of PROM and timely diagnosis is essential to reduce maternal and perinatal morbidity and mortality. Women who experience PROM should be informed that they are at higher risk of a similar complication in a subsequent pregnancy and that early initiation of prenatal care in future pregnancies could reduce the risk of another preterm delivery.

  7. A review of preference-based measures for the assessment of quality of life in children and adolescents with cerebral palsy.

    Science.gov (United States)

    Mpundu-Kaambwa, Christine; Chen, Gang; Huynh, Elisabeth; Russo, Remo; Ratcliffe, Julie

    2018-03-22

    To examine the psychometric properties and suitability for use within the context of cerebral palsy research in children and adolescents of generic preference-based outcome measures (PROMs). Nine electronic databases were searched in this systematic review. The consensus-based standards for the selection of health measurement instruments (COSMIN) checklist were used to measure the psychometric properties of the PROMs. A meta-analysis was used to pool correlation coefficients for convergent validity using the Schmidt-Hunter method. Heterogeneity was assessed using the I-squared statistic (I 2 ). Four preference-based PROMs were identified from eight studies: Health Utilities Index-Mark 2 and 3 (HUI-2 and HUI-3, respectively), the Assessment Quality of Life-4 dimension (AQoL-4D) and the EuroQol-5 dimension 3 level (EQ-5D-3L). Only the HUI system was primarily developed for application with children/adolescents though health-state values for scoring the PROM were elicited from adults. The HUI-3 covered the most relevant constructs though it excludes important modules of health-related quality of life (HRQOL) such as activity limitations and participation restrictions. In terms of psychometric properties, evidence was presented for only five of COSMIN measurement properties: reliability (HUI3), measurement error (HUI-3), content validity (HUI-2 and HUI-3), Hypotheses testing (HUI-3 and AQoL-4D) and criterion validity (HUI-3). No papers reported on internal consistency, structural validity, cross-cultural validity or responsiveness of the preference-based measures in children and adolescents with cerebral palsy. This review highlights the dearth in studies using preference-based PROMs to measure HRQOL associated with cerebral palsy in children and adolescents. The HUI-3 demonstrated the strongest psychometric properties, though it does not cover all dimensions relevant to this population.

  8. An intronic deletion in the PROM1 gene leads to autosomal recessive cone-rod dystrophy.

    Science.gov (United States)

    Eidinger, Osnat; Leibu, Rina; Newman, Hadas; Rizel, Leah; Perlman, Ido; Ben-Yosef, Tamar

    2015-01-01

    To investigate the genetic basis for autosomal recessive cone-rod dystrophy (CRD) in a consanguineous Israeli Jewish family. Patients underwent a detailed ophthalmic evaluation, including eye examination, visual field testing, optical coherence tomography (OCT), and electrophysiological tests, electroretinography (ERG) and visual evoked potential (VEP). Genome-wide homozygosity mapping using a single nucleotide polymorphism (SNP) array was performed to identify homozygous regions shared among two of the affected individuals. Mutation screening of the underlying gene was performed with direct sequencing. In silico and in vitro analyses were used to predict the effect of the identified mutation on splicing. The affected family members are three siblings who have various degrees of progressive visual deterioration, glare, color vision abnormalities, and night vision difficulties. Visual field tests revealed central scotomas of different extension. Cone and rod ERG responses were reduced, with cones more severely affected. Homozygosity mapping revealed several homozygous intervals shared among two of the affected individuals. One included the PROM1 gene. Sequence analysis of the 26 coding exons of PROM1 in one affected individual revealed no mutations in the coding sequence or in intronic splice sites. However, in intron 21, proximate to the intron-exon junction, we observed a homozygous 10 bp deletion between positions -26 and -17 (c.2281-26_-17del). The deletion was linked to a known SNP, c.2281-6C>G. The deletion cosegregated with the disease in the family, and was not detected in public databases or in 101 ethnically-matched control individuals. In silico analysis predicted that this deletion would lead to altered intron 21 splicing. Bioinformatic analysis predicted that a recognition site for the SRSF2 splicing factor is located within the deleted sequence. The in vitro splicing assay demonstrated that c.2281-26_-17del leads to complete exon 22 skipping. A novel

  9. Outcomes in chevron osteotomy for Hallux Valgus in a large cohort.

    Science.gov (United States)

    van Groningen, Bart; van der Steen, M C Marieke; Reijman, Max; Bos, Janneke; Hendriks, Johannes G E

    2016-12-01

    Clinical and radiological related outcomes have been reported for Chevron osteotomy as correction for mild to moderate hallux valgus, but only for relatively small patient series. Moreover, evaluation of the patient's point of view has mostly been conducted by means of more physician-based outcome measures. The goal of this study was to evaluate the effect of the Chevron osteotomy for hallux valgus on patients' daily lives using the Foot and Ankle Outcome Score (FAOS) as a validated and a hallux valgus specific patient reported outcome measure (PROM). Secondary outcome measures were radiological correction, complication rate, and re-operations. All 438 Chevron procedures (336 patients), at two surgical hospital sites in the period between January 2010 and October 2014, were retrospectively evaluated with a follow-up of at least 6 months. Patients were invited to fill in a cross-sectional online FAOS. For the FAOS, a total response of 60% was achieved. The FAOS ranged between 71 and 88 with a follow-up of on average 36 months. Patients with an undercorrection of their hallux valgus (11.6% of the procedures) scored significantly lower on three subscales of the FAOS (range between 61 and 77 versus 72-84). Patients who had a reoperation (12.6% of the procedures) also scored significantly lower on four subscales: 58-100 versus 73-89. Postoperative radiological measurements improved significantly with a mean difference of 6.1 (5.9; 6.4) degrees for the intermetatarsal angle and 13.7 (13.0; 14.5) degrees for the hallux valgus angle. In this large study cohort, Chevron osteotomy for hallux valgus offers good PROM scores on FAOS. These scores were significantly lower in patients with radiological undercorrection or with a reoperation. Results of the FAOS appear to modulate with physician based outcomes and therapeutic incidents. Improvement of outcome may therefore well be possible by increased attention on these surgical details. Copyright © 2016 Elsevier Ltd. All rights

  10. Outcome of Induction and Associated Factors among Term and Post

    African Journals Online (AJOL)

    GB

    354 records ... The purpose of this study was to analyze outcome of induction with ... (PROM), post-term pregnancy, maternal medical ... restriction, iso-immunization), preeclampsia, and .... provides services for approximately 9000 inpatient.

  11. The Prevalence Of Sexually Transmitted Infections On Teen Pregnancies And Their Association To Adverse Pregnancy Outcomes.

    Science.gov (United States)

    Rodriguez Gonzalez, Zaskia M; Leavitt, Karla; Martin, Jose; Benabe, Erika; Romaguera, Josefina; Negrón, Ivette

    2015-01-01

    Based on our population data, the teen pregnancy rate and the prevalence of sexually transmitted infections (STIs) reported during pregnancy are worrisome. STIs appear to pose a threat to pregnancy outcomes including preterm birth (PTB), neonatal low birth weight (NLBW) and premature rupture of membranes (PROM). The objective of this study is to determine the prevalence of STIs in pregnant teens and the association of this variable to adverse pregnancy outcomes. We performed a cross sectional study to assess the prevalence of STIs among pregnant teens during a 4-year period at our institution. Birth outcomes such as gestational age at delivery, PROM and NLBW were analyzed and compared with adults. In the four years of our study, teen pregnancy rate fluctuated from 21.7% in 2010 to 16.8% in 2013. The rate of STIs for adult and teen pregnancies was similar, 21% and 23%, respectively. Chlamydia was the most common STI (67.3%) for both groups. PTB was more prevalent among adults affected with STIs than teens, 13.8% and 11.5%, respectively. NLBW was similar among teens and adults with STIs. PROM complicated 9.1% of teen pregnancies with STIs, compared to 6.7% in adults. There was no significant correlation between the STIs and adverse pregnancy outcomes on teen pregnancies for our population, except for PROM. This age group is associated with a high-risk sexual behavior and poor adherence to treatment. They would benefit from efforts to prevent unintended pregnancies and infectious diseases.

  12. ORACLE--antibiotics for preterm prelabour rupture of the membranes: short-term and long-term outcomes.

    Science.gov (United States)

    Kenyon, S; Taylor, D J; Tarnow-Mordi, W O

    2002-01-01

    Preterm prelabour rupture of the foetal membranes (pPROM) is the most common antecedent of preterm birth and can lead to death, neonatal disease and long-term disability. Previous small trials of antibiotics for pPROM suggested some health benefits for the neonate, but the results were inconclusive. A large, randomized, multicentre trial was undertaken to try to resolve this issue. In total, 4826 women with pPROM were randomized to one of four treatments: 325 mg co-amoxiclav plus 250 mg erythromycin, co-amoxiclav plus erythromycin placebo, erythromycin plus co-amoxiclav placebo, or co-amoxiclav placebo plus erythromycin placebo, four times daily for 10 d or until delivery. The primary outcome measure was a composite of neonatal death, chronic lung disease or major cerebral abnormality on ultrasonography before discharge from hospital. The analysis was undertaken by intention to treat. Indications of short-term respiratory function, chronic lung disease and major neonatal cerebral abnormality were reduced with the prescription of erythromycin. In contrast, the use of co-amoxiclav was associated with a significant increase in the occurrence of neonatal necrotizing enterocolitis. Prophylactic antibiotics can play a role in preterm prelabour rupture of the membranes in reducing infant morbidity.

  13. Evaluation and demonstration of commercialization potential of CCSI tools within gPROMS advanced simulation platform

    Energy Technology Data Exchange (ETDEWEB)

    Lawal, Adekola [Process Systems Enterprise Inc., Cedar Knolls, NJ (United States); Schmal, Pieter [Process Systems Enterprise Inc., Cedar Knolls, NJ (United States); Ramos, Alfredo [Process Systems Enterprise Inc., Cedar Knolls, NJ (United States); Cano, Alejandro [Process Systems Enterprise Inc., Cedar Knolls, NJ (United States); Bhattacharyya, Debangsu [West Virginia Univ., Morgantown, WV (United States); Mebane, David [West Virginia Univ., Morgantown, WV (United States); Sahinidis, Nikolaos [Carnegie Mellon Univ., Pittsburgh, PA (United States); Chowdhury, Ananya [Process Systems Enterprise Inc., Cedar Knolls, NJ (United States); Liu, Xiaohui [Process Systems Enterprise Inc., Cedar Knolls, NJ (United States); Bellinghausen, Stefan [Process Systems Enterprise Inc., Cedar Knolls, NJ (United States)

    2017-05-29

    PSE, in the first phase of the CCSI commercialization project, set out to identify market opportunities for the CCSI tools combined with existing gPROMS platform capabilities and develop a clear technical plan for the proposed commercialization activities.

  14. Development and validation of a condition-specific diary to measure severity, bothersomeness and impact on daily activities for patients with acute urinary tract infection in primary care

    DEFF Research Database (Denmark)

    Holm, Anne; Cordoba, Gloria; Siersma, Volkert

    2017-01-01

    Background: Urinary tract infection (UTI) is a common condition in primary care. Patient-reported outcome measures (PROMs) are crucial in the evaluation of interventions to improve diagnosis, treatment and prognosis of UTI. The aim of this study was to identify an existing condition-specific PROM...... for polytomous items in a cohort of 451 women participating in two studies regarding UTI. Results: No existing PROM fulfilled the inclusion criteria. Content validation resulted in one domain concerning symptom severity (18 items), one concerning bothersomeness (18 items), and one concerning impact on daily...... activities (7 items). Psychometrical validation resulted in four dimensions in each of the first two domains and one dimension in the third domain. Conclusions: Domains were not unidimensional, which meant that we identified dimensions of patient-experienced UTI that differed substantially from those...

  15. The impact of tobacco use on preterm premature rupture of the membranes.

    Science.gov (United States)

    Andres, Robert L; Zhao, Yuan; Klebanoff, Mark A; Hauth, John C; Caritis, Steve N; Carey, J Christopher; Wapner, Ronald J; Iams, Jay D; Leveno, Kenneth J; Miodovnik, Menachem; Sibai, Baha; Van Dorsten, J Peter; Dombrowski, Mitchell P; O'Sullivan, Mary J; Langer, Oded

    2013-03-01

    To determine if tobacco use increases the incidence of preterm premature rupture of the membranes (pPROM) or alters perinatal outcomes after pPROM. This is a secondary analysis of the databases of three completed Eunice Kennedy Shriver National Institute of Child Health and Human Development-supported Maternal Fetal Medicine Units Network studies. Self-reported tobacco exposure data was obtained. Its relationship with the incidence of pPROM and associated neonatal outcome measures were assessed. There was no difference in the incidence of pPROM when comparing nonsmokers to those using tobacco. Although a trend was seen between the incidence of pPROM and the amount smoked, this did not reach statistical significance. Among the patients with pPROM, the use of tobacco was not associated with an increase in perinatal morbidity. Our data do not support a significant relationship between tobacco use and pPROM. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  16. Feasibility of the collection of patient-reported outcomes in an ambulatory neurology clinic.

    Science.gov (United States)

    Moura, Lidia M V R; Schwamm, Eli; Moura Junior, Valdery; Seitz, Michael P; Hsu, John; Cole, Andrew J; Schwamm, Lee H

    2016-12-06

    To determine whether patients could self-report physical and mental health assessments in the waiting room and whether these assessments would be associated with modified Rankin Scale (mRS) and Quality of Life in Epilepsy (QOLIE-10) scores. We offered iPad-based surveys to consecutive adult neurology patients at check-in to collect patient-reported outcome measures (PROMs). We collected demographic and clinical data on 6,075 patients through survey or administrative claims and PROMs from participating patients. We compared demographic characteristics of participants and nonparticipants and tested associations between physical and mental health scores and mRS and QOLIE-10. Of 6,075 patients seen by neurologists during the study period, 2,992 (49.3%) participated in the survey. Compared to nonparticipating patients, participating patients more often were privately insured (53.5% vs 42.7%, p neurology (nonsubspecialty) clinics (53.1% vs 46.6%, p Neurology.

  17. Clinical research in implant dentistry: evaluation of implant-supported restorations, aesthetic and patient-reported outcomes.

    Science.gov (United States)

    Lang, Niklaus P; Zitzmann, Nicola U

    2012-02-01

    The articles discussed in working group 3 dealt with specific aspects of clinical research. In this context, the literature reporting on survival and complication rates of implant-supported or implant-tooth supported restorations in longitudinal studies of at least 5 years were discussed. The second aspect dealt with the evaluation of aesthetic outcomes in clinical studies and the related index systems available. Finally, the third aspect discussed dealt with patient-reported outcome measures (PROMs). A detailed appraisal of the available methodology was presented. © 2012 John Wiley & Sons A/S.

  18. Neonatal and infant outcomes in twin gestations with preterm premature rupture of membranes at 24-31 weeks of gestation.

    Science.gov (United States)

    Mendez-Figueroa, Hector; Dahlke, Joshua D; Viteri, Oscar A; Chauhan, Suneet P; Rouse, Dwight J; Sibai, Baha M; Blackwell, Sean C

    2014-08-01

    To describe the perinatal and infant and early childhood morbidity associated with preterm premature rupture of membranes (PROM) in a cohort of twin pregnancies evaluated prospectively with neonatal follow-up to 2 years of age. This was a secondary analysis of a randomized controlled trial of magnesium sulfate for prevention of cerebral palsy. Inclusion criteria were twin gestation with preterm PROM diagnosed between 24 0/7 and 31 6/7 weeks of gestation and planned expectant management. Latency (time from membrane rupture to delivery) and perinatal outcomes were evaluated by gestational age at membrane rupture. Long-term neonatal outcomes were also analyzed. Among 151 women who met inclusion criteria, the median gestational age at preterm PROM was 28.1 weeks (range 24.1-31.6 weeks). Approximately one-third of women achieved a latency of at least 1 week. Gestational age at preterm PROM (odds ratio [OR] 0.75, 95% confidence interval [CI] 0.63-0.90 for each week after 24 weeks of gestation) and cervical dilation at admission (OR 0.66, 95% CI 0.49-0.90 for each centimeter of dilation) were inversely associated with a latency period of at least 1 week. There were no stillbirths (95% CI 0-1%), but the rate of neonatal mortality was 90 per 1,000 newborns (95% CI 57-112) with a 7.3% cerebral palsy rate among survivors (95% CI 4.4-10.3%). In twin pregnancies, preterm PROM from 24 to 31 weeks of gestation is associated with a neonatal mortality rate of 9.0% and an overall cerebral palsy rate of 7.3%. A longer latency period is associated with less advanced cervical dilation and later gestational age at PROM. LEVEL OF EVIEDENCE: II.

  19. No difference in joint awareness after mobile- and fixed-bearing total knee arthroplasty: 3-year follow-up of a randomized controlled trial.

    Science.gov (United States)

    Schotanus, M G M; Pilot, P; Vos, R; Kort, N P

    2017-12-01

    To compare the patients ability to forget the artificial knee joint in everyday life who were randomized to be operated for mobile- or fixed-bearing total knee arthroplasty (TKA). This single-center randomized controlled trial evaluated the 3-year follow-up of the cemented mobile- and fixed-bearing TKA from the same brand in a series of 41 patients. Clinical examination was during the pre-, 6-week, 6-month, 1-, 2- and 3-year follow-up containing multiple patient-reported outcome measures (PROMs) including the 12-item Forgotten Joint Score (FJS-12) at 3 years. Effect size was calculated for each PROM at 3-year follow-up to quantify the size of the difference between both bearings. At 3-year follow-up, general linear mixed model analysis showed that there were no significant or clinically relevant differences between the two groups for all outcome measures. Calculated effect sizes were small (awareness was slightly lower in patients operated with the MB TKA with comparable improved clinical outcome and PROMs at 3-year follow-up. Measuring joint awareness with the FJS-12 is useful and provides more stringent information at 3-year follow-up compared to other PROMs and should be the PROM of choice at each follow-up after TKA. Level I, randomized controlled trial.

  20. Udvikling og validering af patientrapporterede spørgeskemaer – del 2

    DEFF Research Database (Denmark)

    Willert, Cecilie Balslev; Hölmich, Lisbet Rosenkrantz; Thorborg, Kristian

    2015-01-01

    Test Theory and Item Response Theory, psychometric validation and the measurement properties of a PROM. The latter is based on the COSMIN (consensus-based standards for the selection of health measurement instruments) guidelines, which are developed to assist in development and evaluation of PROMs.......Patient-reported outcome measurements (PROMs) are often questionnaires which provide and rate the patient's point of view in the measurement of subjective clinical phenomena such as pain or quality of life. In the second of two articles we describe field-testing, the psychometric theories Classical...

  1. Hand-related physical function in rheumatic hand conditions

    DEFF Research Database (Denmark)

    Klokker, Louise; Terwee, Caroline B; Wæhrens, Eva Ejlersen

    2016-01-01

    as well as those items from the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) item bank that are relevant to patients with rheumatic hand conditions. Selection will be based on consensus among reviewers. Content validity of selected items will be established......INTRODUCTION: There is no consensus about what constitutes the most appropriate patient-reported outcome measurement (PROM) instrument for measuring physical function in patients with rheumatic hand conditions. Existing instruments lack psychometric testing and vary in feasibility...... and their psychometric qualities. We aim to develop a PROM instrument to assess hand-related physical function in rheumatic hand conditions. METHODS AND ANALYSIS: We will perform a systematic search to identify existing PROMs to rheumatic hand conditions, and select items relevant for hand-related physical function...

  2. Hand-related physical function in rheumatic hand conditions

    DEFF Research Database (Denmark)

    Klokker, Louise; Terwee, Caroline; Wæhrens, Eva Elisabet Ejlersen

    2016-01-01

    INTRODUCTION: There is no consensus about what constitutes the most appropriate patient-reported outcome measurement (PROM) instrument for measuring physical function in patients with rheumatic hand conditions. Existing instruments lack psychometric testing and vary in feasibility...... and their psychometric qualities. We aim to develop a PROM instrument to assess hand-related physical function in rheumatic hand conditions. METHODS AND ANALYSIS: We will perform a systematic search to identify existing PROMs to rheumatic hand conditions, and select items relevant for hand-related physical function...... as well as those items from the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) item bank that are relevant to patients with rheumatic hand conditions. Selection will be based on consensus among reviewers. Content validity of selected items will be established...

  3. The patellofemoral pain and osteoarthritis subscale of the KOOS (KOOS-PF)

    DEFF Research Database (Denmark)

    Crossley, Kay M; Macri, Erin M; Cowan, Sallie M

    2018-01-01

    with patellofemoral pain and/or osteoarthritis and 14 health and medical clinicians. Item reduction was performed using data from patellofemoral cohorts (n=138). We used the COnsesus-based Standards for the selection of health Measurements INstruments guidelines to evaluate reliability, validity, responsiveness......BACKGROUND: Patellofemoral pain and osteoarthritis are prevalent and associated with substantial pain and functional impairments. Patient-reported outcome measures (PROMs) are recommended for research and clinical use, but no PROMs are specific for patellofemoral osteoarthritis, and existing PROMs...... for patellofemoral pain have methodological limitations. This study aimed to develop a new subscale of the Knee injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF), and evaluate its measurement properties. METHODS: Items were generated using input from 50 patients...

  4. Measurement of prosocial reasoning among Chinese adolescents.

    Science.gov (United States)

    Lai, Frank H Y; Siu, Andrew M H; Chan, Chewtyn C H; Shek, Daniel T L

    2012-01-01

    This study attempted to develop a standardized instrument for assessment of prosocial reasoning in Chinese populations. The Prosocial Reasoning Objective Measure (PROM) was translated, and a two-stage study was conducted to evaluate the psychometric properties of the translated instrument. The content validity, cultural relevance, and reading level of the translated instrument were evaluated by an expert panel. Upon revisions according to the expert opinions, the Chinese PROM demonstrated good content validity, "good-to-very good test-retest" reliability, and internal consistency. However, only partial support to the convergent validity of the Chinese PROM was found. In the first stage of the study (n = 50), the PROM scores had high positive correlations with empathy and negative correlations with personal distress and fantasy. These results were consistent with theoretical expectations, although this is also a concern that empathy had a close-to-unity correlation with PROM score in the small sample study of stage 1. In the second stage of the study (n = 566), the relationship between PROM scores and prosocial behavior appeared to be weak. Results suggest that there were many personal, family, or social factors that were linked to prosocial behavior, and prosocial reasoning might only contribute to a small proportion of variation in prosocial behavior among adolescents.

  5. Measurement of Prosocial Reasoning among Chinese Adolescents

    Directory of Open Access Journals (Sweden)

    Frank H. Y. Lai

    2012-01-01

    Full Text Available This study attempted to develop a standardized instrument for assessment of prosocial reasoning in Chinese populations. The Prosocial Reasoning Objective Measure (PROM was translated, and a two-stage study was conducted to evaluate the psychometric properties of the translated instrument. The content validity, cultural relevance, and reading level of the translated instrument were evaluated by an expert panel. Upon revisions according to the expert opinions, the Chinese PROM demonstrated good content validity, “good-to-very good test-retest” reliability, and internal consistency. However, only partial support to the convergent validity of the Chinese PROM was found. In the first stage of the study (=50, the PROM scores had high positive correlations with empathy and negative correlations with personal distress and fantasy. These results were consistent with theoretical expectations, although this is also a concern that empathy had a close-to-unity correlation with PROM score in the small sample study of stage 1. In the second stage of the study (=566, the relationship between PROM scores and prosocial behavior appeared to be weak. Results suggest that there were many personal, family, or social factors that were linked to prosocial behavior, and prosocial reasoning might only contribute to a small proportion of variation in prosocial behavior among adolescents.

  6. The Cambridge Otology Quality of Life Questionnaire: an otology-specific patient-recorded outcome measure. A paper describing the instrument design and a report of preliminary reliability and validity.

    Science.gov (United States)

    Martin, T P C; Moualed, D; Paul, A; Ronan, N; Tysome, J R; Donnelly, N P; Cook, R; Axon, P R

    2015-04-01

    The Cambridge Otology Quality of Life Questionnaire (COQOL) is a patient-recorded outcome measurement (PROM) designed to quantify the quality of life of patients attending otology clinics. Item-reduction model. A systematically designed long-form version (74 items) was tested with patient focus groups before being presented to adult otology patients (n. 137). Preliminary item analysis tested reliability, reducing the COQOL to 24 questions. This was then presented in conjunction with the SF-36 (V1) questionnaire to a total of 203 patients. Subsequently, these were re-presented at T + 3 months, and patients recorded whether they felt their condition had improved, deteriorated or remained the same. Non-responders were contacted by post. A correlation between COQOL scores and patient perception of change was examined to analyse content validity. Teaching hospital and university psychology department. Adult patients attending otology clinics with a wide range of otological conditions. Item reliability measured by item–total correlation, internal consistency and test– retest reliability. Validity measured by correlation between COQOL scores and patient-reported symptom change. Reliability: the COQOL showed excellent internal consistency at both initial presentation (a = 0.90) and 3 months later (a = 0.93). Validity: One-way analysis of variance showed a significant difference between groups reporting change and those reporting no change in quality of life (F(2, 80) = 5.866, P < 0.01). The COQOL is the first otology-specific PROM. Initial studies demonstrate excellent reliability and encouraging preliminary criterion validity: further studies will allow a deeper validation of the instrument.

  7. Health Equity Considerations for Developing and Reporting Patient-reported Outcomes in Clinical Trials

    DEFF Research Database (Denmark)

    Petkovic, Jennifer; Barton, Jennifer L; Flurey, Caroline

    2017-01-01

    , and (6) consideration of statistical power of subgroup analyses for outcome reporting. CONCLUSION: There is a need to (1) conduct a systematic review to assess how equity and population characteristics have been considered in PROM development and whether these differences influence the ranking...

  8. Expectations of younger patients concerning activities after knee arthroplasty: are we asking the right questions?

    Science.gov (United States)

    Witjes, Suzanne; van Geenen, Rutger C I; Koenraadt, Koen L M; van der Hart, Cor P; Blankevoort, Leendert; Kerkhoffs, Gino M M J; Kuijer, P Paul F M

    2017-02-01

    Indications for total and unicondylar knee arthroplasty (KA) have expanded to younger patients, in which Patient-Reported Outcome Measures (PROMs) often show ceiling effects. This might be due to higher expectations. Our aims were to explore expectations of younger patients concerning activities in daily life, work and leisure time after KA and to assess to what extent PROMs meet and evaluate these activities of importance. Focus groups were performed among osteoarthritis (OA) patients leisure time after KA. Additionally, 28 activities of daily life, 17 of work and 27 of leisure time were depicted from seven PROMS, which were rated on importance, frequency and bother. A total score, representing motivation for surgery, was also calculated. Data saturation was reached after six focus groups including 37 patients. Younger OA patients expect to perform better on 16 activities after KA, including high-impact leisure time activities. From the PROMs, daily life and work activities were rated high in both importance and motivation for surgery, but for leisure time activities importance varied highly between patients. All seven PROMs score activities of importance, but no single PROM incorporates all activities rated important. Younger patients expect to perform better on many activities of daily life, work and leisure time after KA, and often at demanding levels. To measure outcomes of younger patients, we suggest using PROMs that include work and leisure time activities besides daily life activities, in which preferably scored activities can be individualized.

  9. Patient-reported outcomes and aesthetic evaluation of root coverage procedures: a 12-month follow-up of a randomized controlled clinical trial.

    Science.gov (United States)

    Stefanini, Martina; Jepsen, Karin; de Sanctis, Massimo; Baldini, Nicola; Greven, Björn; Heinz, Bernd; Wennström, Jan; Cassel, Björn; Vignoletti, Fabio; Sanz, Mariano; Jepsen, Søren; Zucchelli, Giovanni

    2016-12-01

    To assess patient-reported outcome measures (PROMs), aesthetics and stability of root coverage procedures from a previous 6-month RCT after 1 year. Forty-five patients (90 recessions) had received a coronally advanced flap (CAF = control) only or a xenogeneic collagen matrix in addition (CAF + CMX = test). Visual analogue scales (VAS) and questionnaires were used for PROMs and the root coverage aesthetic score (RES) for professional aesthetic evaluations. VAS scores (patient satisfaction) amounted to 8.58 ± 1.86 (test) versus 8.38 ± 2.46 (control). Six patients preferred CAF + CMX concerning surgical procedure and aesthetics, six preferred CAF and 29 were equally satisfied. RES was 7.85 ± 2.42 for the test group versus 7.34 ± 2.90 for the controls. Root coverage (RC) was 76.28% for test and 75.05% for control defects. The mean increase in keratinized tissue width was higher in test (from 1.97 to 3.02 mm) than in controls (from 2.00 to 2.64 mm) (p = 0.0413). Likewise, test sites showed more gain in gingival thickness (0.52 mm) than control sites (0.27 mm) (p = 0.0023). Compared to 6 months, clinical outcomes were stable. Results for PROMs, RES and RC did not significantly differ between treatment groups. Thickness and width of keratinized tissue were enhanced following CAF + CMX compared to CAF alone. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  10. UK-based prospective cohort study to anglicise and validate the FACE-Q Skin Cancer Module in patients with facial skin cancer undergoing surgical reconstruction: the PROMISCR (Patient-Reported Outcome Measure in Skin Cancer Reconstruction) study.

    Science.gov (United States)

    Dobbs, Thomas; Hutchings, Hayley A; Whitaker, Iain S

    2017-09-24

    Skin cancer is the most common malignancy worldwide, often occurring on the face, where the cosmetic outcome of treatment is paramount. A number of skin cancer-specific patient-reported outcome measures (PROMs) exist, however none adequately consider the difference in type of reconstruction from a patient's point of view. It is the aim of this study to 'anglicise' (to UK English) a recently developed US PROM for facial skin cancer (the FACE-Q Skin Cancer Module) and to validate this UK version of the PROM. The validation will also involve an assessment of the items for relevance to facial reconstruction patients. This will either validate this new measure for the use in clinical care and research of various facial reconstructive options, or provide evidence that a more specific PROM is required. This is a prospective validation study of the FACE-Q Skin Cancer Module in a UK facial skin cancer population with a specific focus on the difference between types of reconstruction. The face and content validity of the FACE-Q questionnaire will initially be assessed by a review process involving patients, skin cancer specialists and methodologists. An assessment of whether questions are relevant and any missing questions will be made. Initial validation will then be carried out by recruiting a cohort of 100 study participants with skin cancer of the face pre-operatively. All eligible patients will be invited to complete the questionnaire preoperatively and postoperatively. Psychometric analysis will be performed to test validity, reliability and responsiveness to change. Subgroup analysis will be performed on patients undergoing different forms of reconstruction postexcision of their skin cancer. This study has been approved by the West Midlands, Edgbaston Research Ethics Committee (Ref 16/WM/0445). All personal data collected will be anonymised and patient-specific data will only be reported in terms of group demographics. Identifiable data collected will include the

  11. Measurement of Prosocial Reasoning among Chinese Adolescents

    OpenAIRE

    Frank H. Y. Lai; Andrew M. H. Siu; Chewtyn C. H. Chan; Daniel T. L. Shek

    2012-01-01

    This study attempted to develop a standardized instrument for assessment of prosocial reasoning in Chinese populations. The Prosocial Reasoning Objective Measure (PROM) was translated, and a two-stage study was conducted to evaluate the psychometric properties of the translated instrument. The content validity, cultural relevance, and reading level of the translated instrument were evaluated by an expert panel. Upon revisions according to the expert opinions, the Chinese PROM demonstrated goo...

  12. Influence of the mental health status on a new measure of objective functional impairment in lumbar degenerative disc disease.

    Science.gov (United States)

    Stienen, Martin N; Smoll, Nicolas R; Joswig, Holger; Snagowski, Jan; Corniola, Marco V; Schaller, Karl; Hildebrandt, Gerhard; Gautschi, Oliver P

    2017-06-01

    The Timed Up and Go (TUG) test has recently been proposed as a simple and standardized measure for objective functional impairment (OFI) in patients with lumbar degenerative disc disease (DDD). The study aimed to explore the relationship between a patient's mental health status and both patient-reported outcome measures (PROMs) and TUG test results. This is a prospective institutional review board-approved two-center study. The sample was composed of 375 consecutive patients scheduled for lumbar spine surgery and a healthy cohort of 110 control subjects. Patients and control subjects were assessed with the TUG test and a comprehensive panel of subjective PROMs of pain intensity (visual analog scale [VAS]), functional impairment (Roland-Morris Disability Index [RMDI]), Oswestry Disability Index [ODI]), as well as health-related quality of life (hrQoL; Euro-Qol [EQ]-5D). Standardized age- and sex-adjusted TUG test T-scores were calculated. The dependent variable was the short-form (SF)-12 mental component summary (MCS) quartiles, and the independent variables were the TUG T-scores and PROMs. Direct and adjusted analyses of covariance were performed to estimate the interaction between the SF-12 MCS quartiles and the independent variables. In patients, there was a significant decrease in the subjective PROMs, notably the VAS back pain (p=.001) and VAS leg pain (p=.035), as well as significant increase in the RMDI (pmental hrQoL on subjective measures of pain, functional impairment, and hrQoL that might lead to bias when evaluating patients with lumbar DDD who suffer from reduced mental hrQoL. The TUG test appears to be a stable instrument and especially helpful in the evaluation of patients with lumbar DDD and mental health problems. Copyright © 2016 Elsevier Inc. All rights reserved.

  13. Periodontal disease and some adverse perinatal outcomes in a cohort of low risk pregnant women

    Directory of Open Access Journals (Sweden)

    Cecatti Jose G

    2010-11-01

    Full Text Available Abstract Objective To evaluate the association of periodontal disease (PD in pregnancy with some adverse perinatal outcomes. Method This cohort study included 327 pregnant women divided in groups with or without PD. Indexes of plaque and gingival bleeding on probing, probing pocket depth, clinical attachment level and gingival recession were evaluated at one periodontal examination below 32 weeks of gestation. The rates of preterm birth (PTB, low birth weight (LBW, small for gestational age (SGA neonates and prelabor rupture of membranes (PROM were evaluated using Risk Ratios (95%CI and Population Attributable Risk Fractions. Results PD was associated with a higher risk of PTB (RRadj. 3.47 95%CI 1.62-7.43, LBW (RRadj. 2.93 95%CI 1.36-6.34 and PROM (RRadj. 2.48 95%CI 1.35-4.56, but not with SGA neonates (RR 2.38 95%CI 0.93 - 6.10. Conclusions PD was a risk factor for PT, LBW and PROM among Brazilian low risk pregnant women.

  14. What is important for you? A qualitative interview study of living with diabetes and experiences of diabetes care to establish a basis for a tailored Patient-Reported Outcome Measure for the Swedish National Diabetes Register.

    Science.gov (United States)

    Svedbo Engström, Maria; Leksell, Janeth; Johansson, Unn-Britt; Gudbjörnsdottir, Soffia

    2016-03-24

    There is a growing emphasis on the perspective of individuals living with diabetes and the need for a more person-centred diabetes care. At present, the Swedish National Diabetes Register (NDR) lacks patient-reported outcome measures (PROMs) based on the perspective of the patient. As a basis for a new PROM, the aim of this study was to describe important aspects in life for adult individuals with diabetes. Semistructured qualitative interviews analysed using content analysis. Hospital-based outpatient clinics and primary healthcare clinics in Sweden. 29 adults with type 1 diabetes mellitus (DM) (n=15) and type 2 DM (n=14). Swedish adults (≥ 18 years) living with type 1 DM or type 2 DM (duration ≥ 5 years) able to describe their situation in Swedish. Purposive sampling generated heterogeneous characteristics. To live a good life with diabetes is demanding for the individual, but experienced barriers can be eased by support from others in the personal sphere, and by professional support from diabetes care. Diabetes care was a crucial resource to nurture the individual's ability and knowledge to manage diabetes, and to facilitate life with diabetes by supplying support, guidance, medical treatment and technical devices tailored to individual needs. The analysis resulted in the overarching theme 'To live a good life with diabetes' constituting the two main categories 'How I feel and how things are going with my diabetes' and 'Support from diabetes care in managing diabetes' including five different categories. Common aspects were identified including the experience of living with diabetes and support from diabetes care. These will be used to establish a basis for a tailored PROM for the NDR. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  15. Can patient-reported measurements of pain be used to improve cancer pain management? A systematic review and meta-analysis.

    Science.gov (United States)

    Adam, Rosalind; Burton, Christopher D; Bond, Christine M; de Bruin, Marijn; Murchie, Peter

    2017-12-01

    Cancer pain is a distressing and complex experience. It is feasible that the systematic collection and feedback of patient-reported outcome measurements (PROMs) relating to pain could enhance cancer pain management. We aimed to conduct a systematic review of interventions in which patient-reported pain data were collected and fed back to patients and/or professionals in order to improve cancer pain control. MEDLINE, EMBASE and CINAHL databases were searched for randomised and non-randomised controlled trials in which patient-reported data were collected and fed back with the intention of improving pain management by adult patients or professionals. We conducted a narrative synthesis. We also conducted a meta-analysis of studies reporting pain intensity. 29 reports from 22 trials of 20 interventions were included. PROM measures were used to alert physicians to poorly controlled pain, to target pain education and to link treatment to management algorithms. Few interventions were underpinned by explicit behavioural theories. Interventions were inconsistently applied or infrequently led to changes in treatment. Narrative synthesis suggested that feedback of PROM data tended to increase discussions between patients and professionals about pain and/or symptoms overall. Meta-analysis of 12 studies showed a reduction in average pain intensity in intervention group participants compared with controls (mean difference=-0.59 (95% CI -0.87 to -0.30)). Interventions that assess and feedback cancer pain data to patients and/or professionals have so far led to modest reductions in cancer pain intensity. Suggestions are given to inform and enhance future PROM feedback interventions. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  16. Integrating patient reported outcomes with clinical cancer registry data: a feasibility study of the electronic Patient-Reported Outcomes From Cancer Survivors (ePOCS) system.

    Science.gov (United States)

    Ashley, Laura; Jones, Helen; Thomas, James; Newsham, Alex; Downing, Amy; Morris, Eva; Brown, Julia; Velikova, Galina; Forman, David; Wright, Penny

    2013-10-25

    Routine measurement of Patient Reported Outcomes (PROs) linked with clinical data across the patient pathway is increasingly important for informing future care planning. The innovative electronic Patient-reported Outcomes from Cancer Survivors (ePOCS) system was developed to integrate PROs, collected online at specified post-diagnostic time-points, with clinical and treatment data in cancer registries. This study tested the technical and clinical feasibility of ePOCS by running the system with a sample of potentially curable breast, colorectal, and prostate cancer patients in their first 15 months post diagnosis. Patients completed questionnaires comprising multiple Patient Reported Outcome Measures (PROMs) via ePOCS within 6 months (T1), and at 9 (T2) and 15 (T3) months, post diagnosis. Feasibility outcomes included system informatics performance, patient recruitment, retention, representativeness and questionnaire completion (response rate), patient feedback, and administration burden involved in running the system. ePOCS ran efficiently with few technical problems. Patient participation was 55.21% (636/1152) overall, although varied by approach mode, and was considerably higher among patients approached face-to-face (61.4%, 490/798) than by telephone (48.8%, 21/43) or letter (41.0%, 125/305). Older and less affluent patients were less likely to join (both Pplanning and for targeting service provision.

  17. MRC ORACLE Children Study. Long term outcomes following prescription of antibiotics to pregnant women with either spontaneous preterm labour or preterm rupture of the membranes

    Directory of Open Access Journals (Sweden)

    Salt Alison

    2008-04-01

    Full Text Available Abstract Background The Medical Research Council (MRC ORACLE trial evaluated the use of co-amoxiclav 375 mg and/or erythromycin 250 mg in women presenting with preterm rupture of membranes (PROM ORACLE I or in spontaneous preterm labour (SPL ORACLE II using a factorial design. The results showed that for women with a singleton baby with PROM the prescription of erythromycin is associated with improvements in short term neonatal outcomes, although co-amoxiclav is associated with prolongation of pregnancy, a significantly higher rate of neonatal necrotising enterocolitis was found in these babies. Prescription of erythromycin is now established practice for women with PROM. For women with SPL antibiotics demonstrated no improvements in short term neonatal outcomes and are not recommended treatment. There is evidence that both these conditions are associated with subclinical infection so perinatal antibiotic administration may reduce the risk of later disabilities, including cerebral palsy, although the risk may be increased through exposure to inflammatory cytokines, so assessment of longer term functional and educational outcomes is appropriate. Methods The MRC ORACLE Children's Study will follow up UK children at age 7 years born to 4809 women with PROM and the 4266 women with SPL enrolled in the earlier ORACLE trials. We will use a parental questionnaire including validated tools to assess disability and behaviour. We will collect the frequency of specific medical conditions: cerebral palsy, epilepsy, respiratory illness including asthma, diabetes, admission to hospital in last year and other diseases, as reported by parents. National standard test results will be collected to assess educational attainment at Key Stage 1 for children in England. Discussion This study is designed to investigate whether or not peripartum antibiotics improve health and disability for children at 7 years of age. Trial registration The ORACLE Trial and Children

  18. MRC ORACLE Children Study. Long term outcomes following prescription of antibiotics to pregnant women with either spontaneous preterm labour or preterm rupture of the membranes.

    Science.gov (United States)

    Kenyon, Sara; Brocklehurst, Peter; Jones, David; Marlow, Neil; Salt, Alison; Taylor, David

    2008-04-24

    The Medical Research Council (MRC) ORACLE trial evaluated the use of co-amoxiclav 375 mg and/or erythromycin 250 mg in women presenting with preterm rupture of membranes (PROM) ORACLE I or in spontaneous preterm labour (SPL) ORACLE II using a factorial design. The results showed that for women with a singleton baby with PROM the prescription of erythromycin is associated with improvements in short term neonatal outcomes, although co-amoxiclav is associated with prolongation of pregnancy, a significantly higher rate of neonatal necrotising enterocolitis was found in these babies. Prescription of erythromycin is now established practice for women with PROM. For women with SPL antibiotics demonstrated no improvements in short term neonatal outcomes and are not recommended treatment. There is evidence that both these conditions are associated with subclinical infection so perinatal antibiotic administration may reduce the risk of later disabilities, including cerebral palsy, although the risk may be increased through exposure to inflammatory cytokines, so assessment of longer term functional and educational outcomes is appropriate. The MRC ORACLE Children's Study will follow up UK children at age 7 years born to 4809 women with PROM and the 4266 women with SPL enrolled in the earlier ORACLE trials. We will use a parental questionnaire including validated tools to assess disability and behaviour. We will collect the frequency of specific medical conditions: cerebral palsy, epilepsy, respiratory illness including asthma, diabetes, admission to hospital in last year and other diseases, as reported by parents. National standard test results will be collected to assess educational attainment at Key Stage 1 for children in England. This study is designed to investigate whether or not peripartum antibiotics improve health and disability for children at 7 years of age. The ORACLE Trial and Children Study is registered in the Current Controlled Trials registry. ISCRTN 52995660.

  19. Využití měr variability pro nominální proměnné ve vícerozměrné statistické analýze

    Czech Academy of Sciences Publication Activity Database

    Řezanková, Hana; Šulc, Z.; Húsek, Dušan

    2016-01-01

    Roč. 12, č. 1 (2016), s. 34-43 ISSN 1336-7420 Grant - others:IGA VŠE(CZ) F4/41/2016 Institutional support: RVO:67985807 Keywords : míry variability * nominální proměnné * vícerozměrná analýza * míry závislosti * míry podobnosti * shluková analýza * rozhodovací stromy * hodnocení klasifikace * variability measures * nominal variables * multivariate analysis * dependence measures * similarity measures * cluster analysis * decision trees * classification evaluation Subject RIV: BB - Applied Statistics, Operational Research http://www.ssds.sk/casopis/archiv/2016/fss0116.pdf

  20. Danish Hip Arthroscopy Registry (DHAR)

    DEFF Research Database (Denmark)

    Lund, Bent; Mygind-Klavsen, Bjarne; Grønbech Nielsen, Torsten

    2017-01-01

    The Danish Hip Arthroscopy Registry (DHAR) was initiated in January 2012 as a web-based prospective registry. The purpose of this study was to evaluate and report the first registry based outcome data of a national population with radiological and clinical femoroacetabular impingement (FAI......) undergoing hip arthroscopic treatment. Our primary hypothesis was that patients undergoing hip arthroscopy would improve significantly in pain, quality of life and sports related outcome measurements in Patient Related Outcome Measures (PROM). Peri-operative data and Patient Reported Outcome Measures (PROM......-5 D demonstrated improvement after 1 and 2 years from 0.66 pre-op to 0.78 at 2 years. HSAS improved significantly from 2.5 to 3.3. Pain score data demonstrated improvement in NRS-rest 39 to 17 and NRS Walk 49 to 22 at follow-up. We conclude that patients with FAI undergoing hip arthroscopy...

  1. Conceptual basis of outcome measures.

    Science.gov (United States)

    Keith, R A

    1995-01-01

    Because of its treatment configuration and the assumption of long-term benefit, rehabilitation has had a continuing interest in the measurement of outcomes. The utility of outcome indicators rests on their conceptual foundations, the technical development of measures and validation research. Some measures, particularly of functional status, have become increasingly sophisticated with the application of psychometric and statistical analysis techniques. Less effort has been devoted to an elaboration of their theoretical basis. A first step is an examination of the assumptions underlying outcome measures, the purpose of this article. Central to an understanding is clarification of definitions of key terms such as outcomes, independence, impairment, disability and handicap. All outcome measures must be seen as part of a social context of norms and expectations. However, most norms in rehabilitation are implied rather than explicit. The assumptions behind several common outcomes are examined with suggestions for ways to increase their utility. The ability of rehabilitation to compete in the current climate, stressing cost-effectiveness, will depend heavily on the robustness of outcome measures.

  2. French translation and cross-cultural adaptation of the Michigan Hand Outcomes Questionnaire and the Brief Michigan Hand Outcomes Questionnaire.

    Science.gov (United States)

    Efanov, J I; Shine, J J; Darwich, R; Besner Morin, C; Arsenault, J; Harris, P G; Danino, A M; Izadpanah, A

    2018-04-01

    Patient-Reported Outcome Measures (PROMs) are important clinical devices for evaluating injuries and surgeries of the hand. However, some of the most widely used questionnaires, such as the MHQ and bMHQ, are currently unavailable in French, which prevents them from being used in the French Canadian province of Quebec as well as in other French-speaking nations. We therefore intend to develop valid and culturally adapted French translations of the afore-mentioned questionnaires. Two independent bilingual translators converted all English questionnaires to French. Two distinct translators then translated the French versions back to English in reverse-blinded fashion. Discrepancies between the original and second English versions were examined by a committee of four bilingual healthcare professionals before final French translations of all documents were produced. Thirty patients bilingual in French and English were then asked to complete the original and French versions of the MHQ and bMHQ. Their answers were compared in order to assess the accuracy of our translation. In light of these findings, revised French versions were produced. French versions of the MHQ and bMHQ questionnaires produced metrological qualities of validity and fidelity with an inter-class correlation superior to 0.90 and a kappa coefficient of 0.81 to 1. Clinical applicability revealed the distribution of scores according to disease process was reproducible between the English and French versions. PROM translation requires a rigorous process in order to achieve strong metrological qualities in both the original and translated versions. We produced French translations of the MHQ and bMHQ by abiding to the Beaton method of cross-cultural adaptation of self-reported measures. Copyright © 2017 SFCM. Published by Elsevier Masson SAS. All rights reserved.

  3. The early development phases of a European Organisation for Research and Treatment of Cancer (EORTC) module to assess patient reported outcomes (PROs) in women undergoing breast reconstruction.

    Science.gov (United States)

    Thomson, H J; Winters, Z E; Brandberg, Y; Didier, F; Blazeby, J M; Mills, J

    2013-03-01

    A comprehensive evaluation of breast reconstruction (BRR) surgery includes measurement of patient reported outcomes (PROs). There is, however, a lack of validated BRR-specific PRO measures (PROMs) that adequately assess relevant issues. This study is developing a European Organisation for Research and Treatment of Cancer (EORTC) questionnaire/module specific for PROs in BRR to supplement the cancer-core and breast cancer EORTC questionnaires, respectively: the QLQ-C30 and QLQ-BR23. Phases I and II of questionnaire development followed EORTC guidelines including a systematic literature review to identify all potential 'issues' (concepts relevant to PROs) and semi-structured interviews with 89 patients and 9 European multi-disciplinary health care professionals (HCPs) (Sweden, Italy and the United Kingdom [UK]). Interviewers asked participants the 'relevance' of outcomes identified in the literature and captured additional 'issues' of importance. The literature search and interviews of patients and HCPs yielded 69 issues relating to BRR operationalised into 31 provisional items (single questions) for the module, which was conceptualised to contain five scales: treatment/surgery related symptoms (affecting the shoulder, arm and reconstructed breast), body image, sexuality, cosmetic outcomes (pertaining to three areas: breast, donor site and nipple) and overall satisfaction. The provisional development of the EORTC BRR module has 31 items addressing issues of importance to patients as well as HCPs. Further international testing is underway as a UK National Cancer Research Network trial to ensure that this PROM will be psychometrically and clinically robust and applicable for use in clinical trials, cohort studies, national audit and clinical practice. Copyright © 2012 Elsevier Ltd. All rights reserved.

  4. Relationship of blood lead levels to obstetric outcome

    Energy Technology Data Exchange (ETDEWEB)

    Angell, N.F.; Lavery, J.P.

    1982-01-01

    Lead represents a significant environmental hazard to pregnant women and their offspring. Exposure to high environmental levels of lead has been associated with spontaneous abortion, premature rupture of fetal membranes (PROM), and preterm delivery. The relationship between lower exposures and obstetric complications is unknown. The concentration of lead in the blood was measured in 635 specimens of umbilical cord blood collected at delivery. No relationship was found between concentrations of lead in cord blood and the incidence of PROM, preterm delivery, preeclampsia, or meconium staining. Maternal and infant capillary blood was collected 24 hours post partum from 154 of these deliveries. The concentrations of lead in the blood did not vary significantly among cord, infant, and maternal samples, and the three measurements were highly correlated. Levels of zinc protoporphyrin (ZnP) were increased in cord blood as compared with mothers' blood, but no concentration-response relationships between the ratio of cord ZnP to maternal ZnP and lead were found.

  5. Antioxidant Vitamin Status in the Serum and Amniotic Fluid of Women with Premature Rupture of the Fetal Membranes.

    Science.gov (United States)

    Barrett, Bridget M.

    The purpose of this study was to examine the status of antioxidant vitamins in women with premature rupture of the fetal membranes. Specimens of blood and amniotic fluid were obtained from 80 pregnant subjects included both smokers and non-smokers during the third trimester. The concentrations of ascorbic acid (ASA), beta -carotene, retinol and alpha -tocopherol in serum and amniotic fluid were determined. The experimental group consisted of those subjects with PROM while the control subjects were those with normal pregnancy. No statistical differences were found between the PROM and control groups in retinol and vitamin E concentrations in amniotic fluid and serum. Serum ASA concentrations of PROM subjects were not different from controls, but the PROM subjects had significantly lower amniotic fluid ASA concentrations. However, in a study with fewer subjects a lower serum ASA concentration in the PROM subjects was observed. The ratio of amniotic fluid ASA concentration to ASA serum concentration was significantly lower in PROM patients than in controls in both studies. This suggests that low levels of ASA in the amniotic fluid, but not in serum is better associated with PROM. A low amniotic fluid concentration of ASA may reflect an inefficient transfer and/or increased fetal utilization. Alterations in ASA concentration in the amniotic fluid may affect the integrity of the chorioamnion leading to PROM. beta -Carotene was not found in the amniotic fluid. Serum beta-carotene levels were significantly lower in the PROM group compared to the control group. Low concentrations of beta-carotene in maternal serum in smokers not only associated with poor maternal outcome (PROM) but also compromised the fetal outcome (decreased birth weight). Maintenance of adequate serum beta-carotene concentration and amniotic fluid ASA in smokers may result in better maternal and fetal outcome. This study demonstrated that nutrition is an important factor in the prevention of PROM.

  6. Transabdominal amnioinfusion in preterm premature rupture of membranes: a randomised controlled trial.

    Science.gov (United States)

    Tranquilli, Andrea Luigi; Giannubilo, Stefano Raffaele; Bezzeccheri, Valeria; Scagnoli, Caterina

    2005-06-01

    To evaluate the role of transabdominal amnioinfusion in improving the perinatal outcomes of pregnancies complicated by preterm premature rupture of membranes (pPROM). A randomised controlled trial. A teaching hospital in Italy, obstetric unit. Population Women with singleton pregnancies complicated by pPROM, between 24 + 0 and 32 + 6 weeks of gestation. Patients were randomised 24 hours after admission to our referral hospital, to expectant management with transabdominal amnioinfusion or expectant management only. The effects of transabdominal amnioinfusion on pPROM-delivery interval and on perinatal outcomes. Of the 65 women with pPROM 34 met the inclusion criteria. Seventeen women were assigned to amnioinfusion (the amnioinfusion group) and the other 17 to expectant management. Compared with the control group (median: 8 days; range: 3-14), the pPROM-delivery period was significantly longer in women who underwent amnioinfusion (median: 21 days; range: 15-29) (P amnioinfusion were less likely to deliver within seven days since pPROM (RR: 0.18; range: 0.04-0.69 95% CI) or within two weeks (RR: 0.46; range: 0.21-1.02 95% CI). In the amnioinfusion group the neonatal survival was significantly higher at each gestational age (P amnioinfusion after pPROM resulted in significant prolongation of pregnancy and better neonatal outcomes.

  7. Five-Year Experience of Vitamin E-Diffused Highly Cross-Linked Polyethylene Wear in Total Hip Arthroplasty Assessed by Radiostereometric Analysis

    DEFF Research Database (Denmark)

    Nebergall, Audrey K; Troelsen, Anders; Rubash, Harry E

    2016-01-01

    BACKGROUND: Vitamin E-diffused highly cross-linked polyethylene (VEPE) was developed to reduce oxidation without compromising mechanical strength. The purpose of this study was to evaluate VEPE in vivo using radiostereometric analysis (RSA) and patient-reported outcome measures (PROMs). METHODS......: Fifty-one hips were enrolled. Each patient received a VEPE liner, a porous titanium shell, and an uncemented stem with a 32-mm cobalt-chrome femoral head. Tantalum beads were inserted into the VEPE to measure femoral head penetration using RSA. RSA radiographs and PROMs were obtained preoperatively...

  8. Outcome measures in inflammatory rheumatic diseases.

    NARCIS (Netherlands)

    Fransen, J.; Riel, P.L.C.M. van

    2009-01-01

    Inflammatory rheumatic diseases are generally multifaceted disorders and, therefore, measurement of multiple outcomes is relevant to most of these diseases. Developments in outcome measures in the rheumatic diseases are promoted by the development of successful treatments. Outcome measurement will

  9. Dutch-Flemish translation of nine pediatric item banks from the Patient-Reported Outcomes Measurement Information System (PROMIS)®.

    Science.gov (United States)

    Haverman, Lotte; Grootenhuis, Martha A; Raat, Hein; van Rossum, Marion A J; van Dulmen-den Broeder, Eline; Hoppenbrouwers, Karel; Correia, Helena; Cella, David; Roorda, Leo D; Terwee, Caroline B

    2016-03-01

    The Patient-Reported Outcomes Measurement Information System (PROMIS(®)) is a new, state-of-the-art assessment system for measuring patient-reported health and well-being of adults and children. It has the potential to be more valid, reliable, and responsive than existing PROMs. The items banks are designed to be self-reported and completed by children aged 8-18 years. The PROMIS items can be administered in short forms or through computerized adaptive testing. This paper describes the translation and cultural adaption of nine PROMIS item banks (151 items) for children in Dutch-Flemish. The translation was performed by FACITtrans using standardized PROMIS methodology and approved by the PROMIS Statistical Center. The translation included four forward translations, two back-translations, three independent reviews (at least two Dutch, one Flemish), and pretesting in 24 children from the Netherlands and Flanders. For some items, it was necessary to have separate translations for Dutch and Flemish: physical function-mobility (three items), anger (one item), pain interference (two items), and asthma impact (one item). Challenges faced in the translation process included scarcity or overabundance of possible translations, unclear item descriptions, constructs broader/smaller in the target language, difficulties in rank ordering items, differences in unit of measurement, irrelevant items, or differences in performance of activities. By addressing these challenges, acceptable translations were obtained for all items. The Dutch-Flemish PROMIS items are linguistically equivalent to the original USA version. Short forms are now available for use, and entire item banks are ready for cross-cultural validation in the Netherlands and Flanders.

  10. Menstrual questionnaires for clinical and research use.

    Science.gov (United States)

    Matteson, Kristen A

    2017-04-01

    Patient-reported outcome measures (PROMs) have the potential to be extremely valuable in the clinical care delivery for women who report heavy menstrual bleeding (HMB). Increasingly, studies on HMB have incorporated PROMs to evaluate the impact of bleeding on quality of life. These measures have included semiquantitative charts and pictograms, questionnaires to assess symptoms and impact on quality of life, and health-related quality of life questionnaires. Recent systematic reviews have highlighted inconsistency of outcome measurement across studies on HMB as a challenge limiting the interpretability of the body of literature and the ability to generate consensus on the relative effectiveness of treatment options. Consequently, research initiatives and international collaborations are working to harmonize outcome measurement. Harmonizing the use of questionnaires in research and clinical care has the potential to improve patient-centered care delivery for women with HMB and improve the generation of patient-focused evidence-based guidelines for the evaluation and treatment of HMB. Copyright © 2016. Published by Elsevier Ltd.

  11. Premature rupture of the membranes at term: time to reevaluate the management.

    Science.gov (United States)

    Sadeh-Mestechkin, Dana; Samara, Nivin; Wiser, Amir; Markovitch, Ofer; Shechter-Maor, Gil; Biron-Shental, Tal

    2016-11-01

    To compare maternal and neonatal outcomes in induced vs. expectant management of term PROM. This retrospective study included patients with term PROM. A total of 325 were enrolled: 213 managed expectantly and 112 induced at admission and matched according to gestational age. Expectant management group patients were allowed to defer labour induction up to 48 h. Primary outcome measures were maternal or foetal signs of infection (chorioamnionitis, early neonatal sepsis or postpartum endometritis) and prolonged maternal hospitalization. Secondary outcome was caesarean delivery rate. All group characteristics were comparable except that expectant management included more nulliparous women. Women managed expectantly had a higher rate of prolonged hospitalization [15 (7 %) vs. 2 (1.8 %); P = 0.043] as an indication of maternal complications, compared to induction management. They also had a higher rate of caesarean delivery [34 (16.4 %) vs. 8 (7.1 %), respectively; P = 0.024]. Adjustment for parity did not change the results. Early neonatal outcomes were similar between groups. Expectant management increases the likelihood of caesarean delivery and prolonged maternal hospitalization. This should be considered when advising patients with term PROM regarding labour induction.

  12. A systematic review of the measurement properties of the Body Image Scale (BIS) in cancer patients.

    Science.gov (United States)

    Melissant, Heleen C; Neijenhuijs, Koen I; Jansen, Femke; Aaronson, Neil K; Groenvold, Mogens; Holzner, Bernhard; Terwee, Caroline B; van Uden-Kraan, Cornelia F; Cuijpers, Pim; Verdonck-de Leeuw, Irma M

    2018-06-01

    Body image is acknowledged as an important aspect of health-related quality of life in cancer patients. The Body Image Scale (BIS) is a patient-reported outcome measure (PROM) to evaluate body image in cancer patients. The aim of this study was to systematically review measurement properties of the BIS among cancer patients. A search in Embase, MEDLINE, PsycINFO, and Web of Science was performed to identify studies that investigated measurement properties of the BIS (Prospero ID 42017057237). Study quality was assessed (excellent, good, fair, poor), and data were extracted and analyzed according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology on structural validity, internal consistency, reliability, measurement error, hypothesis testing for construct validity, and responsiveness. Evidence was categorized into sufficient, insufficient, inconsistent, or indeterminate. Nine studies were included. Evidence was sufficient for structural validity (one factor solution), internal consistency (α = 0.86-0.96), and reliability (r > 0.70); indeterminate for measurement error (information on minimal important change lacked) and responsiveness (increasing body image disturbance in only one study); and inconsistent for hypothesis testing (conflicting results). Quality of the evidence was moderate to low. No studies reported on cross-cultural validity. The BIS is a PROM with good structural validity, internal consistency, and test-retest reliability, but good quality studies on the other measurement properties are needed to optimize evidence. It is recommended to include a wider variety of cancer diagnoses and treatment modalities in these future studies.

  13. 42 CFR 486.318 - Condition: Outcome measures.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Outcome measures. 486.318 Section 486... Organizations Organ Procurement Organization Outcome Requirements § 486.318 Condition: Outcome measures. (a..., territories, or possessions, an OPO must meet all 3 of the following outcome measures: (1) The OPO's donation...

  14. Patient Self-Assessed Passive Range of Motion of the Knee Cannot Replace Health Professional Measurements

    DEFF Research Database (Denmark)

    Borgbjerg, Jens; Madsen, Frank; Odgaard, Anders

    2017-01-01

    The purpose of this study was to investigate whether patients can accurately self-assess their knee passive range of motion (PROM). A picture-based questionnaire for patient self-assessment of knee PROM was developed and posted to patients. The self-assessed PROM from 58 patients was compared...... (≥ 10-degree flexion contracture). Surgeon- and patient-assessed knee PROM showed a mean difference (95% limits of agreement) of -2.1 degrees (-42.5 to 38.3 degrees) for flexion and -8.1 degrees (-28.8 to 12.7 degrees) for extension. The sensitivity of patient self-assessed PROM in identifying knee...

  15. Development of the Knee Numeric-Entity Evaluation Score (KNEES – ACL)

    DEFF Research Database (Denmark)

    Comins, J D; Krogsgaard, M R; Brodersen, J

    2013-01-01

    Patient-related outcome measures (PROMs) are commonly used to gauge treatment effects in patients with anterior cruciate ligament (ACL) deficiency. Valid measures of specific conditions depend on relevant item content. While item content can be derived either from clinicians (face validity) or fr...

  16. Social Connectedness and Perceived Listening Effort in Adult Cochlear Implant Users: A Grounded Theory to Establish Content Validity for a New Patient-Reported Outcome Measure.

    Science.gov (United States)

    Hughes, Sarah E; Hutchings, Hayley A; Rapport, Frances L; McMahon, Catherine M; Boisvert, Isabelle

    2018-02-08

    Individuals with hearing loss often report a need for increased effort when listening, particularly in challenging acoustic environments. Despite audiologists' recognition of the impact of listening effort on individuals' quality of life, there are currently no standardized clinical measures of listening effort, including patient-reported outcome measures (PROMs). To generate items and content for a new PROM, this qualitative study explored the perceptions, understanding, and experiences of listening effort in adults with severe-profound sensorineural hearing loss before and after cochlear implantation. Three focus groups (1 to 3) were conducted. Purposive sampling was used to recruit 17 participants from a cochlear implant (CI) center in the United Kingdom. The participants included adults (n = 15, mean age = 64.1 years, range 42 to 84 years) with acquired severe-profound sensorineural hearing loss who satisfied the UK's national candidacy criteria for cochlear implantation and their normal-hearing significant others (n = 2). Participants were CI candidates who used hearing aids (HAs) and were awaiting CI surgery or CI recipients who used a unilateral CI or a CI and contralateral HA (CI + HA). Data from a pilot focus group conducted with 2 CI recipients were included in the analysis. The data, verbatim transcripts of the focus group proceedings, were analyzed qualitatively using constructivist grounded theory (GT) methodology. A GT of listening effort in cochlear implantation was developed from participants' accounts. The participants provided rich, nuanced descriptions of the complex and multidimensional nature of their listening effort. Interpreting and integrating these descriptions through GT methodology, listening effort was described as the mental energy required to attend to and process the auditory signal, as well as the effort required to adapt to, and compensate for, a hearing loss. Analyses also suggested that listening effort for most participants was

  17. Outcomes of Pregnancies Complicated by Preterm Premature Rupture of Membranes Between 20 and 24 Weeks of Gestation.

    Science.gov (United States)

    Kibel, Mia; Asztalos, Elizabeth; Barrett, Jon; Dunn, Michael S; Tward, Carly; Pittini, Alex; Melamed, Nir

    2016-08-01

    To assess the natural history and contemporary outcomes in pregnancies complicated by previable preterm premature rupture of membranes (PROM). Retrospective study of all women with a singleton or twin pregnancy admitted to a single tertiary referral center who experienced preterm PROM between 20 and 23 6/7 weeks of gestation during 2004-2014 and underwent expectant management. Women electing termination of pregnancy and pregnancies complicated by major fetal anomalies were excluded. Severe neonatal morbidity was defined as a composite of bronchopulmonary dysplasia, severe neurologic injury, or severe retinopathy of prematurity. Long-term follow-up to a corrected age of 18-21 months was available for the majority of surviving neonates. Of the 140 neonates born to women with previable preterm PROM during the study period, 104 were eligible for the study. Overall 51 (49.0%, 95% confidence interval [CI] 39.4-58.6%) newborns survived to discharge, of whom 24 (47.1%, 95% CI 33.4-60.8%) experienced severe neonatal morbidity. The overall rate of long-term morbidity among surviving neonates was 23.3% (95% CI 11.7-34.9%) and was significantly higher among neonates who previously experienced severe neonatal morbidity compared with those who did not (39.1% compared with 10.0%, P=.04). The only two factors that were significantly associated with overall survival and survival without severe neonatal morbidity were gestational age at preterm PROM of 22 weeks or greater (adjusted odds ratio [OR] 12.2, 95% CI 3.3-44.8 and adjusted OR 4.8, 95% CI 1.2-19.3, respectively) and a latency period of greater than 7 days (adjusted OR 10.1, 95% CI 3.2-31.6, and adjusted OR 6.7, 95% CI 2.2-21.0, respectively). Expectant management was associated with maternal risks including placental abruption (17.3%, 95% CI 10.0-24.6%) and sepsis (4.8%, 95% CI 0.7-8.9%). Expectant management in pregnancies complicated by previable preterm PROM between 20 and 23 6/7 weeks of gestation is associated with an

  18. 42 CFR 410.146 - Diabetes outcome measurements.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 2 2010-10-01 2010-10-01 false Diabetes outcome measurements. 410.146 Section 410.146 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Training and Diabetes Outcome Measurements § 410.146 Diabetes outcome measurements. (a) Information...

  19. Prospective memory, retrospective memory, and individual differences in cognitive abilities, personality, and psychopathology.

    Science.gov (United States)

    Uttl, Bob; White, Carmela A; Cnudde, Kelsey; Grant, Laura M

    2018-01-01

    Although individual differences in processing speed, working memory, intelligence, and other cognitive functions were found to explain individual differences in retrospective memory (RetM), much less is known about their relationship with prospective memory (ProM). Moreover, the studies that investigated the relationship between ProM and cognitive functions arrived to contradictory conclusions. The relationship between ProM, personality, and psychopathology is similarly unsettled. Meta-analytic reviews of the relationships of ProM with aging and personality suggest that the contradictory findings may be due to widespread methodological problems plaguing ProM research including the prevalent use of inefficient, unreliable binary measures; widespread ceiling effects; failure to distinguish between various ProM subdomains (e.g., episodic ProM versus vigilance/monitoring); various confounds; and, importantly, small sample sizes, resulting in insufficient statistical power. Accordingly, in a large scale study with nearly 1,200 participants, we investigated the relationship between episodic event-cued ProM, episodic RetM, and fundamental cognitive functions including intelligence, personality, and psychopathology, using reliable continuous measures of episodic event-cued ProM. Our findings show that (a) continuous measures of episodic event-cued ProM were much more reliable than binary measures, (b) episodic event-cued ProM was associated with measures of processing speed, working memory, crystallized and fluid intelligence, as well as RetM, and that such associations were similar for ProM and RetM, (c) personality factors did not improve prediction of neither ProM nor RetM beyond the variance predicted by cognitive ability, (d) symptoms of psychopathology did not improve the prediction of ProM although they slightly improved the prediction of RetM, and (e) participants' sex was not associated with ProM but showed small correlations with RetM. In addition to advancing

  20. The role of decision-making ability in HIV/AIDS: impact on prospective memory.

    Science.gov (United States)

    Coulehan, Kelly; Byrd, Desiree; Arentoft, Alyssa; Monzones, Jennifer; Fuentes, Armando; Fraser, Felicia; Rosario, Ana; Morgello, Susan; Mindt, Monica Rivera

    2014-01-01

    Prospective memory (ProM), a form of episodic memory related to execution of future intentions, is important for everyday functioning. Among persons living with HIV (PLWH), executive dysfunction is implicated in ProM impairments. However, specific subcomponents of executive functioning involved in ProM deficits remain poorly understood. Unlike more "traditional" neurocognitive (NC) measures of executive functioning associated with dorsolateral prefrontal cortex (i.e., conceptual reasoning, abstraction), those associated with medial orbitofrontal/ventromedial prefrontal (mOF/vmP) cortex (i.e., decision making, inhibitory control, goal-oriented behavior) have yet to be examined in ProM. This study characterized ProM ability in a sample of 89 HIV-seropositive adults and examined the unique role of decision-making ability in ProM. Participants completed a standard NC battery, the Iowa Gambling Task (IGT; a decision-making measure), and the Memory for Intentions Screening Test (MIST; a ProM measure). Correlational analyses revealed that both traditional executive functioning measures and the IGT were associated with ProM. Regression analyses revealed that the IGT significantly predicted ProM, even after accounting for NC measures. Among all NC measures, only executive functioning significantly contributed to ProM. Further examination of mOF/vmP-sensitive executive dysfunction within this population is needed as PLWH may require more tailored treatment recommendations due to specific decision-making difficulties that can impact medication management.

  1. The International Dermatology Outcome Measures Group

    DEFF Research Database (Denmark)

    Gottlieb, Alice B; Levin, Adriane A; Armstrong, April W

    2015-01-01

    As quality standards are increasingly in demand throughout medicine, dermatology needs to establish outcome measures to quantify the effectiveness of treatments and providers. The International Dermatology Outcome Measures Group was established to address this need. Beginning with psoriasis...

  2. Measuring outcomes in children's rehabilitation: a decision protocol.

    Science.gov (United States)

    Law, M; King, G; Russell, D; MacKinnon, E; Hurley, P; Murphy, C

    1999-06-01

    To develop and test the feasibility and clinical utility of a computerized self-directed software program designed to enable service providers in children's rehabilitation to make decisions about the most appropriate outcome measures to use in client and program evaluation. A before-and-after design was used to test the feasibility and initial impact of the decision-making outcome software in improving knowledge and use of clinical outcome measures. A children's rehabilitation center in a city of 50,000. All service providers in the children's rehabilitation center. Disciplines represented included early childhood education, occupational therapy, physical therapy, speech and language pathology, audiology, social work, and psychology. Using a conceptual framework based on the International Classification of Impairment, Disability, and Handicap (ICIDH), an outcome measurement decision-making protocol was developed. The decision-making protocol was computerized in an educational software program with an attached database of critically appraised measures. Participants learned about outcome measures through the program and selected outcome measures that met their specifications. The computer software was tested for feasibility in the children's rehabilitation center for 6 months. Knowledge and use of clinical outcome measures were determined before and after the feasibility testing using a survey of all service providers currently at the centre and audits of 30 randomly selected rehabilitation records (at pretest, posttest, and follow-up). Service providers indicated that the outcomes software was easy to follow and believed that the use of the ICIDH framework helped them in making decisions about selecting outcome measures. Results of the survey indicated that there were significant changes in the service providers' level of comfort with selecting measures and knowing what measures were available. Use of outcome measures as identified through the audit did not change

  3. Measurement properties of outcome measures for vitiligo. A systematic review.

    Science.gov (United States)

    Vrijman, Charlotte; Linthorst Homan, May W; Limpens, Jacqueline; van der Veen, Wietze; Wolkerstorfer, Albert; Terwee, Caroline B; Spuls, Phyllis I

    2012-11-01

    OBJECTIVE To summarize and critically appraise the evidence on the measurement properties of clinician-, patient-, and observer-reported outcomes, measuring any construct of interest in patients with all types of vitiligo. DATA SOURCES Electronic databases including PubMed (1948 to July 2011), OVID EMBASE (1980 to July 2011), and CINAHL (EBSCOhost) (1982 to July 2011) were searched. STUDY SELECTION Two authors independently screened all records for eligibility. For inclusion, the study population had to include patients with vitiligo, for which outcome measures were developed or evaluated on their measurement properties. The initial search retrieved 1249 records, of which 14 articles met the inclusion criteria. DATA EXTRACTION Characteristics of the included instruments, study population, and results of the measurement properties were extracted. The Consensus-Based Standards for the Selection of Health Status Measurement Instruments (COSMIN) 4-point checklist, combined with quality criteria for measurement properties, was used to calculate the overall level of evidence per measurement property of each instrument. Independent extraction and assessment was performed by 2 authors. DATA SYNTHESIS Eleven different measurement instruments were identified. Strong evidence was found for a positive internal consistency of the Dermatology Life Quality Index. For other instruments, the evidence of measurement properties was limited or unknown. CONCLUSIONS Recommendations on the use of specific outcome measures for vitiligo should be formulated with caution because current evidence is insufficient owing to a low number of studies with poor methodological quality and unclear clinical relevance. To recommend outcome measures for vitiligo, further research on measurement properties of clinical relevant outcome measures for vitiligo according to COSMIN quality criteria is needed.

  4. Broad-spectrum antibiotics for preterm, prelabour rupture of fetal membranes: the ORACLE I randomised trial. ORACLE Collaborative Group.

    Science.gov (United States)

    Kenyon, S L; Taylor, D J; Tarnow-Mordi, W

    2001-03-31

    Preterm, prelabour rupture of the fetal membranes (pPROM) is the commonest antecedent of preterm birth, and can lead to death, neonatal disease, and long-term disability. Previous small trials of antibiotics for pPROM suggested some health benefits for the neonate, but the results were inconclusive. We did a randomised multicentre trial to try to resolve this issue. 4826 women with pPROM were randomly assigned 250 mg erythromycin (n=1197), 325 mg co-amoxiclav (250 mg amoxicillin plus 125 mg clavulanic acid; n=1212), both (n=1192), or placebo (n=1225) four times daily for 10 days or until delivery. The primary outcome measure was a composite of neonatal death, chronic lung disease, or major cerebral abnormality on ultrasonography before discharge from hospital. Analysis was by intention to treat. Two women were lost to follow-up, and there were 15 protocol violations. Among all 2415 infants born to women allocated erythromycin only or placebo, fewer had the primary composite outcome in the erythromycin group (151 of 1190 [12.7%] vs 186 of 1225 [15.2%], p=0.08) than in the placebo group. Among the 2260 singletons in this comparison, significantly fewer had the composite primary outcome in the erythromycin group (125 of 1111 [11.2%] vs 166 of 1149 [14.4%], p=0.02). Co-amoxiclav only and co-amoxiclav plus erythromycin had no benefit over placebo with regard to this outcome in all infants or in singletons only. Use of erythromycin was also associated with prolongation of pregnancy, reductions in neonatal treatment with surfactant, decreases in oxygen dependence at 28 days of age and older, fewer major cerebral abnormalities on ultrasonography before discharge, and fewer positive blood cultures. Although co-amoxiclav only and co-amoxiclav plus erythromycin were associated with prolongation of pregnancy, they were also associated with a significantly higher rate of neonatal necrotising enterocolitis. Erythromycin for women with pPROM is associated with a range of health

  5. The International Dermatology Outcome Measures Group: formation of patient-centered outcome measures in dermatology.

    Science.gov (United States)

    Gottlieb, Alice B; Levin, Adriane A; Armstrong, April W; Abernethy, April; Duffin, Kristina Callis; Bhushan, Reva; Garg, Amit; Merola, Joseph F; Maccarone, Mara; Christensen, Robin

    2015-02-01

    As quality standards are increasingly in demand throughout medicine, dermatology needs to establish outcome measures to quantify the effectiveness of treatments and providers. The International Dermatology Outcome Measures Group was established to address this need. Beginning with psoriasis, the group aims to create a tool considerate of patients and providers using the input of all relevant stakeholders in assessment of disease severity and response to treatment. Herein, we delineate the procedures through which consensus is being reached and the future directions of the project. Copyright © 2014 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  6. Outcomes and Return to Sport After Revision Anterior Cruciate Ligament Reconstruction in Adolescent Athletes

    Science.gov (United States)

    Saper, Michael; Pearce, Stephanie; Shung, Joseph; Zondervan, Robert; Ostrander, Roger; Andrews, James R.

    2018-01-01

    Background: The number of adolescent anterior cruciate ligament (ACL) injuries is rising with increased participation in higher level athletics at earlier ages. With an increasing number of primary ACL reconstructions (ACLRs) comes a rise in the incidence of revision ACLRs. Purpose: To evaluate the clinical results of revision ACLR across a group of high-level adolescent athletes with at least 2-year follow-up. Study Design: Case series; Level of evidence, 4. Methods: A retrospective review of 21 adolescent athletes (age range, 10-19 years) who underwent revision ACLR with at least 2-year follow-up was conducted. Patient-reported outcome measures (PROMs) included the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, Lysholm knee scoring scale, Tegner activity level scale, and modified Cincinnati Knee Rating System. Return to sport (RTS) and overall patient satisfaction were also assessed. Results: The mean age at the time of surgery was 16.5 years (range, 14-19 years), and the mean follow-up was 46.4 months (range, 24-97 months); 42.9% of patients were female, and 52.4% of patients participated in collision sports. The mean time to failure after primary ACLR was 13.1 ± 8.0 months, and the most common mechanism of failure was noncontact in at least 66.7% of cases. The revision graft type included bone–patellar tendon–bone (BPTB) in 71.4% of cases; 26.7% of BPTB grafts were from the contralateral extremity. Concomitant procedures were performed for intra-articular lesions in 71.4% of patients. The mean patient satisfaction rate was 95.3%. There were 3 cases of a graft reinjury at a mean of 25 months postoperatively. The mean PROM scores were as follows: IKDC, 87.5 ± 12.7; Tegner, 7.2 ± 2.0; Lysholm, 93.7 ± 9.8; and Cincinnati, 93.4 ± 10.0. Of those attempting to RTS, 68.4% of patients successfully returned at the same level of competition. Patients with a lateral compartment chondral injury were less likely to RTS (P < .05

  7. Patient-Reported Outcomes After Radiation Therapy in Men With Prostate Cancer: A Systematic Review of Prognostic Tool Accuracy and Validity

    Energy Technology Data Exchange (ETDEWEB)

    O' Callaghan, Michael E., E-mail: elspeth.raymond@health.sa.gov.au [South Australian Prostate Cancer Clinical Outcomes Collaborative (Australia); Freemasons Foundation Centre for Men' s Health, University of Adelaide (Australia); Urology Unit, Repatriation General Hospital, SA Health, Flinders Centre for Innovation in Cancer (Australia); Raymond, Elspeth [South Australian Prostate Cancer Clinical Outcomes Collaborative (Australia); Campbell, Jared M. [Joanna Briggs Institute, University of Adelaide (Australia); Vincent, Andrew D. [Freemasons Foundation Centre for Men' s Health, University of Adelaide (Australia); Beckmann, Kerri [South Australian Prostate Cancer Clinical Outcomes Collaborative (Australia); Centre for Population Health Research, University of South Australia (Australia); Roder, David [Centre for Population Health Research, University of South Australia (Australia); Evans, Sue; McNeil, John [Epidemiology and Preventative Medicine, Monash University (Australia); Millar, Jeremy [Radiation Oncology, Alfred Health (Australia); Zalcberg, John [Epidemiology and Preventative Medicine, Monash University (Australia); Borg, Martin [South Australian Prostate Cancer Clinical Outcomes Collaborative (Australia); Adelaide Radiotherapy Centre (Australia); Moretti, Kim [South Australian Prostate Cancer Clinical Outcomes Collaborative (Australia); Freemasons Foundation Centre for Men' s Health, University of Adelaide (Australia); Flinders Centre for Innovation in Cancer, Centre for Population Health Research, University of South Australia (Australia); Discipline of Surgery, University of Adelaide (Australia)

    2017-06-01

    Purpose: To identify, through a systematic review, all validated tools used for the prediction of patient-reported outcome measures (PROMs) in patients being treated with radiation therapy for prostate cancer, and provide a comparative summary of accuracy and generalizability. Methods and Materials: PubMed and EMBASE were searched from July 2007. Title/abstract screening, full text review, and critical appraisal were undertaken by 2 reviewers, whereas data extraction was performed by a single reviewer. Eligible articles had to provide a summary measure of accuracy and undertake internal or external validation. Tools were recommended for clinical implementation if they had been externally validated and found to have accuracy ≥70%. Results: The search strategy identified 3839 potential studies, of which 236 progressed to full text review and 22 were included. From these studies, 50 tools predicted gastrointestinal/rectal symptoms, 29 tools predicted genitourinary symptoms, 4 tools predicted erectile dysfunction, and no tools predicted quality of life. For patients treated with external beam radiation therapy, 3 tools could be recommended for the prediction of rectal toxicity, gastrointestinal toxicity, and erectile dysfunction. For patients treated with brachytherapy, 2 tools could be recommended for the prediction of urinary retention and erectile dysfunction. Conclusions: A large number of tools for the prediction of PROMs in prostate cancer patients treated with radiation therapy have been developed. Only a small minority are accurate and have been shown to be generalizable through external validation. This review provides an accessible catalogue of tools that are ready for clinical implementation as well as which should be prioritized for validation.

  8. Development and psychometric properties of the Suicidality : Treatment Occurring in Paediatrics (STOP) Suicidality Assessment Scale (STOP-SAS) in children and adolescents

    NARCIS (Netherlands)

    Flamarique, I.; Santosh, P.; Zuddas, A.; Arango, C.; Purper-Ouakil, D.; Hoekstra, P. J.; Coghill, D.; Schulze, U.; Dittmann, R. W.; Buitelaar, J. K.; Lievesley, K.; Frongia, R.; Llorente, C.; Mendez, I.; Sala, R.; Fiori, F.; Castro-Fornieles, J.

    2016-01-01

    Background: To create a self-reported, internet-based questionnaire for the assessment of suicide risk in children and adolescents. Methods: As part of the EU project `Suicidality: Treatment Occurring in Paediatrics' (STOP project), we developed web-based Patient Reported Outcome Measures (PROMs)

  9. Development and psychometric properties of the Suicidality: Treatment Occurring in Paediatrics (STOP) Suicidality Assessment Scale (STOP-SAS) in children and adolescents

    NARCIS (Netherlands)

    Flamarique, I.; Santosh, P.; Zuddas, A.; Arango, C.; Purper-Ouakil, D.; Hoekstra, P.J.; Coghill, D.; Schulze, U.; Dittmann, R.W.; Buitelaar, J.K.; Lievesley, K.; Frongia, R.; Llorente, C.; Mendez, I.; Sala, R.; Fiori, F.; Castro-Fornieles, J.

    2016-01-01

    BACKGROUND: To create a self-reported, internet-based questionnaire for the assessment of suicide risk in children and adolescents. METHODS: As part of the EU project 'Suicidality: Treatment Occurring in Paediatrics' (STOP project), we developed web-based Patient Reported Outcome Measures (PROMs)

  10. Systematic Review of Treatment Outcome Measures for Vulvodynia.

    Science.gov (United States)

    Sadownik, Leslie A; Yong, Paul J; Smith, Kelly B

    2018-07-01

    To systematically evaluate the literature regarding vulvodynia treatment outcome measures. A systematic literature search on OVID, PubMed, and PsycINFO databases was conducted from inception until May 2016. Studies were included/excluded based on prespecified criteria. Reported outcome measures were organized into 6 core outcome domains recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT): pain; physical functioning, emotional functioning, participant ratings of global improvement and satisfaction with treatment, symptoms and adverse events, and participant disposition. Of the 206 articles identified for full-text screening, 33 met our criteria. One study adhered to all IMMPACT recommendations. The number of outcomes measured per study ranged from 1 to greater than 20. Patient-reported pain outcomes were found in the majority (27/33; 82%) of studies. Pain severity with intercourse was reported by 24 (73%) of 33 studies-9 different scales were used to measure this outcome. Clinician-reported outcomes were present in 14 (42%) of 33 studies. Methods of measuring vestibular sensitivity by "cotton swab" test were different in 8 of 10 studies. Other domains reported included; physical function (8/33 studies; 24%), sexual function (23/33 studies; 70%), and emotional function (13/33 studies; 39%). Symptoms and adverse events were reported by 15 (45%) of 33 studies. One study formally reported participant disposition using all the information recommended by CONSORT. Comparison of clinical trial results in vulvodynia is not possible because of a lack of standard treatment outcome measures. Vulvodynia researchers should apply the IMMPACT criteria to guide the development of a minimum core set of standard outcome measures that measure holistic health.

  11. Health outcome after major trauma: what are we measuring?

    Science.gov (United States)

    Hoffman, Karen; Cole, Elaine; Playford, E Diane; Grill, Eva; Soberg, Helene L; Brohi, Karim

    2014-01-01

    Trauma is a global disease and is among the leading causes of disability in the world. The importance of outcome beyond trauma survival has been recognised over the last decade. Despite this there is no internationally agreed approach for assessment of health outcome and rehabilitation of trauma patients. To systematically examine to what extent outcomes measures evaluate health outcomes in patients with major trauma. MEDLINE, EMBASE, and CINAHL (from 2006-2012) were searched for studies evaluating health outcome after traumatic injuries. Studies of adult patients with injuries involving at least two body areas or organ systems were included. Information on study design, outcome measures used, sample size and outcomes were extracted. The World Health Organisation International Classification of Function, Disability and Health (ICF) were used to evaluate to what extent outcome measures captured health impacts. 34 studies from 755 studies were included in the review. 38 outcome measures were identified. 21 outcome measures were used only once and only five were used in three or more studies. Only 6% of all possible health impacts were captured. Concepts related to activity and participation were the most represented but still only captured 12% of all possible concepts in this domain. Measures performed very poorly in capturing concepts related to body function (5%), functional activities (11%) and environmental factors (2%). Outcome measures used in major trauma capture only a small proportion of health impacts. There is no inclusive classification for measuring disability or health outcome following trauma. The ICF may provide a useful framework for the development of a comprehensive health outcome measure for trauma care.

  12. Health outcome after major trauma: what are we measuring?

    Directory of Open Access Journals (Sweden)

    Karen Hoffman

    Full Text Available Trauma is a global disease and is among the leading causes of disability in the world. The importance of outcome beyond trauma survival has been recognised over the last decade. Despite this there is no internationally agreed approach for assessment of health outcome and rehabilitation of trauma patients.To systematically examine to what extent outcomes measures evaluate health outcomes in patients with major trauma.MEDLINE, EMBASE, and CINAHL (from 2006-2012 were searched for studies evaluating health outcome after traumatic injuries.Studies of adult patients with injuries involving at least two body areas or organ systems were included. Information on study design, outcome measures used, sample size and outcomes were extracted. The World Health Organisation International Classification of Function, Disability and Health (ICF were used to evaluate to what extent outcome measures captured health impacts.34 studies from 755 studies were included in the review. 38 outcome measures were identified. 21 outcome measures were used only once and only five were used in three or more studies. Only 6% of all possible health impacts were captured. Concepts related to activity and participation were the most represented but still only captured 12% of all possible concepts in this domain. Measures performed very poorly in capturing concepts related to body function (5%, functional activities (11% and environmental factors (2%.Outcome measures used in major trauma capture only a small proportion of health impacts. There is no inclusive classification for measuring disability or health outcome following trauma. The ICF may provide a useful framework for the development of a comprehensive health outcome measure for trauma care.

  13. Measuring patient knowledge of asthma: a systematic review of outcome measures.

    NARCIS (Netherlands)

    Pink, J.; Pink, K.; Elwyn, G.

    2009-01-01

    BACKGROUND: Asthma self-management education is a key component of international guidelines. No gold standard patient centred outcome measure exists for asthma knowledge. Our aim was to identify high-quality, validated, and reliable outcome measures suitable for use in either the research or

  14. Nederlandstalige patiëntgerapporteerde uitkomstmaten voor voet- en enkelaandoeningen; Een systematisch overzicht

    NARCIS (Netherlands)

    Weel, Hanneke; Zwiers, Ruben; Sierevelt, Inger N.; Haverkamp, Daniel; van Dijk, C. Niek; Kerkhoffs, Gino M. M. J.

    2015-01-01

    To investigate which valid and reliable patient-reported outcome measures (PROMs) are available for foot and ankle disorders in the Dutch population, and which of these is the most suitable for uniform use. Systematic review. PubMed, Embase and Google Scholar were systematically searched for

  15. Korean Clinic Based Outcome Measure Studies

    OpenAIRE

    Jongbae Park

    2003-01-01

    Background: Evidence based medicine has become main tools for medical practice. However, conducting a highly ranked in the evidence hierarchy pyramid is not easy or feasible at all times and places. There remains a room for descriptive clinical outcome measure studies with admitting the limit of the intepretation. Aims: Presents three Korean clinic based outcome measure studies with a view to encouraging Korean clinicians to conduct similar studies. Methods: Three studies are presented...

  16. Does acupuncture used in nulliparous women reduce time from prelabour rupture of membranes at term to active phase of labour? A randomised controlled trial.

    Science.gov (United States)

    Selmer-Olsen, Tone; Lydersen, Stian; Mørkved, Siv

    2007-01-01

    To assess if acupuncture influences the onset of labour and the need for induction after prelabour rupture of membranes (PROM) in nulliparous women. Further, to investigate a possible effect of acupuncture on the woman's wellbeing. In a randomised controlled trial (RCT), 106 nulliparous women with PROM were allocated to an acupuncture group (AG) or a control group (CG). The outcome measures were time from PROM to onset of active phase of labour, and rate of inductions if labour was absent after 2 days. The women's self-reported wellbeing was registered on a Visual Analogue Scale (VAS). There was no statistically significant difference between the 2 groups regarding time from PROM to active phase (median times in AG versus CG: 15 versus 20.5 h, p=0.34). Additionally, there was no difference between the 2 groups in the need for induction. We found no significant differences in self-reported wellbeing, but the women receiving acupuncture considered their treatment to be more positive than the controls (p=0.003). No adverse effects were reported. Acupuncture treatment used in nulliparas after PROM showed no significant effect in reducing time to active labour or in reducing rate of inductions. There was no change in wellbeing as a result of acupuncture, but it was considered positive to receive this kind of treatment while waiting for labour to begin.

  17. Staff perceptions of using outcome measures in stroke rehabilitation.

    Science.gov (United States)

    Burton, Louisa-Jane; Tyson, Sarah; McGovern, Alison

    2013-05-01

    The use of standardised outcome measures is an integral part of stroke rehabilitation and is widely recommended as good practice. However, little is known about how measures are actually used or their impact. This study aimed to identify current clinical practice; how healthcare professionals working in stroke rehabilitation use outcome measures and their perceptions of the benefits and barriers to use. Eighty-four Health Care Professionals and 12 service managers and commissioners working in stroke services across a large UK county were surveyed by postal questionnaire. Ninety-six percent of clinical respondents used at least one measure, however, less than half used measures regularly during a patient's stay. The mean number of tools used was 3.2 (SD = 1.9). Eighty-one different tools were identified; 16 of which were unpublished and unvalidated. Perceived barriers in using outcome measures in day-to-day clinical practice included lack of resources (time and training) and lack of knowledge of appropriate measures. Benefits identified were to demonstrate the effectiveness of rehabilitation interventions and monitor patients' progress. Although the use of outcome measures is prevalent in clinical practice, there is little consistency in the tools utilised. The term "outcome measures" is used, but staff rarely used the measures at appropriate time points to formally assess and evaluate outcome. The term "measurement tool" more accurately reflects the purposes to which they were put and potential benefits. Further research to overcome the barriers in using standardised measurement tools and evaluate the impact of implementation on clinical practice is needed. • Health professionals working in stroke rehabilitation should work together to agree when and how outcome measures can be most effectively used in their service. • Efforts should be made to ensure that standardised tools are used to measure outcome at set time-points during rehabilitation, in order to

  18. Use of the WOMAC questionnaire in Mumbai and the challenges of translation and cross cultural adaptation.

    Science.gov (United States)

    Gogtay, N J; Thatte, U M; Dasgupta, B; Deshpande, S

    2013-01-01

    Patient-reported outcome measures (PROMs) are disease specific questionnaires that are being increasingly used in clinical practice and research. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), is a widely used PROM in patients with hip or knee osteoarthritis. A validated WOMAC was used by us, and significant challenges were faced in administering it as several questions did not have a cultural connect. Functionally equivalent items in the Indian context had then to be used to complete the score. With greater emphasis today on the use of patient-reported outcome measures, and with data from multi-centric studies being pooled, cross-cultural adaptation becomes very important if the pooled data are to be really relevant. In India, with several languages being spoken, and a significant proportion of the population being illiterate, the physician and/ or the impartial witness must provide considerable explanation without attempting to influence the response. The key to the effective and correct use of PROMs thus lies not just in translation, but also in a stepwise validation of the questionnaire, and modification in the context of the country where it is used. Scores like WOMAC are often primary efficacy endpoints in clinical trials; are gaining greater importance to support label claims; have ethical implications, and directly impact regulatory decision making and thus, eventually, evidence-based practice.

  19. Measuring Learning Outcomes in Auditing Education

    DEFF Research Database (Denmark)

    Holm, Claus; Steenholdt, Niels

    2003-01-01

    The ability to provide sensible measures for learning outcomes in accounting education is under increased scrutiny. In this paper we use a learner perspective in auditing education, which reflects that some students taking accounting classes also are provided with on-the-job training in accounting...... firms. Hence knowledge about learning outcomes for different groups of students is essential information for educators as well as the accounting profession. This paper extends prior research on the role of declarative and procedural knowledge in performing auditing tasks. Measuring learning outcomes......). The study provides evidence, which confirms an interrelationship between declarative and procedural knowledge in auditing, and the findings also suggest that students with auditing experience perform better than students without experience on procedural questions....

  20. Premature rupture of membranes at term: immediate induction of ...

    African Journals Online (AJOL)

    Objective: To compare the maternal outcomes of immediate induction of labor with expectant management in women presenting with premature rupture of membranes (PROM) at term. Methods: One hundred and fifty two women with PROM at term were randomized into either immediate induction of labor with oxytocin or ...

  1. Hepatology may have problems with putative surrogate outcome measures

    DEFF Research Database (Denmark)

    Gluud, Christian; Brok, Jesper; Gong, Yan

    2007-01-01

    A surrogate outcome measure is a laboratory measurement, a physical sign, or another intermediate substitute that is able to predict an intervention's effect on a clinically meaningful outcome. A clinical outcome detects how a patient feels, functions, or survives. Surrogate outcome measures occur...... faster or more often, are cheaper, and/or are less invasively achieved than the clinical outcome. In practice, validation is surprisingly often overlooked, especially if a biologic plausible rationale is proposed. Surrogate outcomes must be validated before use. The first step in validation...... predicts the intervention's effect on the clinical outcome. In hepatology a number of putative surrogate outcomes are used both in clinical research and in clinical practice without having been properly validated. Sustained virological response to interferons and ribavirin in patients with chronic...

  2. Diagnostic performance of placental alpha-microglobulin-1 test in women with prolonged pre-labour rupture of membranes.

    Science.gov (United States)

    Eleje, George Uchenna; Ezugwu, Euzebus Chinonye; Eke, Ahizechukwu Chigoziem; Eleje, Lydia Ijeoma; Ikechebelu, Joseph Ifeanyichukwu; Afiadigwe, Evaristus Anthony; Ezugwu, Frank O; Udigwe, Gerald Okanandu; Okafor, Charles I; Ezeama, Chukwuemeka Okwudili

    2016-01-01

    To determine diagnostic performance of placental alpha-microglobulin-1 (PAMG-1) test compared to conventional clinical assessment (CCA) in women with prolonged pre-labour rupture of membranes (PROM). A double-blind study of women with symptoms and signs of PROM in Nnamdi Azikiwe University Teaching Hospital, Nnewi and University of Nigeria Teaching Hospital, Enugu, in south-east Nigeria using CCA for PROM and PAMG-1 test was done. Women were included if their symptoms, signs or complaints suggestive of PROM was more than 24 h duration. PROM was diagnosed if two out of three methods from CCA (pooling, positive nitrazine test or ferning) were present. Confirmation of PROM was done after delivery using any two of these clinical criteria: delivery in 48 h to 7 days, evidence of chorioamnionitis, membranes obviously ruptured at delivery and adverse perinatal outcomes strongly correlated with prolonged PROM. Accuracy, specificity and sensitivity value for CCA were 72.5, 36.8 and 86.0% lower than for PAMG-1 test which were 95.7, 94.1 and 96.2%. In equivocal cases, PAMG-1 was significantly more accurate than CCA (92.3% versus 38.5%; p < 0.001). This study in women with prolonged PROM, confirms that PAMG-1 test has high diagnostic accuracy irrespective of the duration of PROM before clinical evaluation.

  3. Culturally Sensitive and Environment-Friendly Outcome Measures in

    African Journals Online (AJOL)

    Dr Olaleye

    A systematic review of evidence on culturally sensitive and environment-friendly outcome measures in ..... which included manual grass cutting/hoeing, assuming the Islamic ... who opined that the starting point for any outcome measure is to ...

  4. The relative proportion of preterm births complicated by premature rupture of membranes in multifetal gestations: a population-based study.

    Science.gov (United States)

    Pakrashi, Tarita; Defranco, Emily A

    2013-01-01

    To compare the relative contribution of premature rupture of membranes (PROM) to preterm births in singleton compared with multifetal gestations. A population-based retrospective cohort study of 291,782 nonanomalous live births in the state of Ohio from January 1, 2006, to December 31, 2007, identified through birth certificate data. Frequency of PROM was compared between singleton and multifetal gestations and then stratified by gestational age at birth. Multivariate regression analysis estimated the risk of PROM by plurality in each gestational age group, accounting for influential risk factors. The frequency of PROM increased with increasing plurality of gestation. The relative proportion of preterm birth < 37 weeks complicated by PROM increased with gestational plurality 13.2% singletons, 16.8% twins, 20.0% triplets, 19.6% quadruplets, and 100% for higher-order multiples (p < 0.001). The frequency of PROM increased with earlier gestational age at birth, regardless of plurality. The increased risk of PROM in multifetal gestation persisted even after adjustment for influential concomitant risk factors. The proportion of preterm birth attributable to PROM increases by plurality of gestation, with its most significant contribution in higher-order multiples and at earliest gestational ages when outcomes are the poorest. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  5. Lumbar spinal stenosis: comparison of surgical practice variation and clinical outcome in three national spine registries.

    Science.gov (United States)

    Lønne, Greger; Fritzell, Peter; Hägg, Olle; Nordvall, Dennis; Gerdhem, Paul; Lagerbäck, Tobias; Andersen, Mikkel; Eiskjaer, Søren; Gehrchen, Martin; Jacobs, Wilco; van Hooff, Miranda L; Solberg, Tore K

    2018-05-21

    Decompression surgery for lumbar spinal stenosis (LSS) is the most common spinal procedure in the elderly. To avoid persisting low back pain, adding arthrodesis has been recommended, especially if there is a coexisting degenerative spondylolisthesis. However, this strategy remains controversial, resulting in practice-based variation. The present study aimed to evaluate in a pragmatic study if surgical selection criteria and variation in use of arthrodesis in three Scandinavian countries can be linked to variation in treatment effectiveness. This is an observational study based on a combined cohort from the national spine registries of Norway, Sweden, and Denmark. Patients aged 50 and older operated during 2011-2013 for LSS were included. Patient-Reported Outcome Measures (PROMs): Oswestry Disability Index (ODI) (primary outcome), Numeric Rating Scale (NRS) for leg pain and back pain, and health-related quality of life (Euro-Qol-5D) were reported. Analysis included case-mix adjustment. In addition, we report differences in hospital stay. Analyses of baseline data were done by analysis of variance (ANOVA), chi-square, or logistic regression tests. The comparisons of the mean changes of PROMs at 1-year follow-up between the countries were done by ANOVA (crude) and analysis of covariance (case-mix adjustment). Out of 14,223 included patients, 10,890 (77%) responded at 1-year follow-up. Apart from fewer smokers in Sweden and higher comorbidity rate in Norway, baseline characteristics were similar. The rate of additional fusion surgery (patients without or with spondylolisthesis) was 11% (4%, 47%) in Norway, 21% (9%, 56%) in Sweden, and 28% (15%, 88%) in Denmark. At 1-year follow-up, the mean improvement for ODI (95% confidence interval) was 18 (17-18) in Norway, 17 (17-18) in Sweden, and 18 (17-19) in Denmark. Patients operated with arthrodesis had prolonged hospital stay. Real-life data from three national spine registers showed similar indications for decompression

  6. G-CSF Intrauterine for Thin Endometrium, and Pregnancy Outcome

    Directory of Open Access Journals (Sweden)

    Ensieh Tehraninejad

    2015-10-01

    Full Text Available Objective:To evaluate effects ofG-CSF on a cancelled ART cycle due to thin endometrium.Materials and methods:In a nonrandomized clinical trial from January 2011 to January 2013 in two tertiary university based hospitals fifteen patients undergoing embryo transfer and with the history of cycle cancellation due to thin endometrium were studied. Intrauterine infusion of G-CSF was done on the day of oocyte pick-up or 5 days before embryo transfer. The primary outcome to be measured was an endometrium thickened to at least 6 mm and the secondary outcome was clinical pregnancy rate and consequently take-home baby. All previous cycles were considered as control for each patient.Results:The G-CSF was infused at the day of oocyte retrieval or 5 days before embryo transfer. The endometrial thickness reached from3.593±0.251 mm to 7.120±0.84 mm. The mean age, gravidity, parity, and FSH were 35.13± 9.531 years,3, 1 and32.78± 31.10 mIU/ml, respectively. The clinical pregnancy rate was 20%, and there was one missed abortion, a mother death at 34 weeks, and a preterm labor at 30 weeks due to PROM.Conclusion:G-CSF may increase endometrial thickness in the small group of patients who had no choice except cycle cancellation or surrogacy.

  7. A systematic review of the measurement properties of the European Organisation for Research and Treatment of Cancer In-patient Satisfaction with Care Questionnaire, the EORTC IN-PATSAT32.

    Science.gov (United States)

    Neijenhuijs, Koen I; Jansen, Femke; Aaronson, Neil K; Brédart, Anne; Groenvold, Mogens; Holzner, Bernhard; Terwee, Caroline B; Cuijpers, Pim; Verdonck-de Leeuw, Irma M

    2018-05-07

    The EORTC IN-PATSAT32 is a patient-reported outcome measure (PROM) to assess cancer patients' satisfaction with in-patient health care. The aim of this study was to investigate whether the initial good measurement properties of the IN-PATSAT32 are confirmed in new studies. Within the scope of a larger systematic review study (Prospero ID 42017057237), a systematic search was performed of Embase, Medline, PsycINFO, and Web of Science for studies that investigated measurement properties of the IN-PATSAT32 up to July 2017. Study quality was assessed, data were extracted, and synthesized according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. Nine studies were included in this review. The evidence on reliability and construct validity were rated as sufficient and of the quality of the evidence as moderate. The evidence on structural validity was rated as insufficient and of low quality. The evidence on internal consistency was indeterminate. Measurement error, responsiveness, criterion validity, and cross-cultural validity were not reported in the included studies. Measurement error could be calculated for two studies and was judged indeterminate. In summary, the IN-PATSAT32 performs as expected with respect to reliability and construct validity. No firm conclusions can be made yet whether the IN-PATSAT32 also performs as well with respect to structural validity and internal consistency. Further research on these measurement properties of the PROM is therefore needed as well as on measurement error, responsiveness, criterion validity, and cross-cultural validity. For future studies, it is recommended to take the COSMIN methodology into account.

  8. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure

    DEFF Research Database (Denmark)

    Roos, Ewa M.; Roos, H P; Lohmander, L S

    1998-01-01

    There is broad consensus that good outcome measures are needed to distinguish interventions that are effective from those that are not. This task requires standardized, patient-centered measures that can be administered at a low cost. We developed a questionnaire to assess short- and long......-term patient-relevant outcomes following knee injury, based on the WOMAC Osteoarthritis Index, a literature review, an expert panel, and a pilot study. The Knee injury and Osteoarthritis Outcome Score (KOOS) is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport...

  9. The Development of NOAA Education Common Outcome Performance Measures (Invited)

    Science.gov (United States)

    Baek, J.

    2013-12-01

    The National Oceanic and Atmospheric Administration (NOAA) Education Council has embarked on an ambitious Monitoring and Evaluation (M&E) project that will allow it to assess education program outcomes and impacts across the agency, line offices, and programs. The purpose of this internal effort is to link outcome measures to program efforts and to evaluate the success of the agency's education programs in meeting the strategic goals. Using an outcome-based evaluation approach, the NOAA Education Council is developing two sets of common outcome performance measures, environmental stewardship and professional development. This presentation will examine the benefits and tradeoffs of common outcome performance measures that collect program results across a portfolio of education programs focused on common outcomes. Common outcome performance measures have a few benefits to our agency and to the climate education field at large. The primary benefit is shared understanding, which comes from our process for writing common outcome performance measures. Without a shared and agreed upon set of definitions for the measure of an outcome, the reported results may not be measuring the same things and would incorrectly indicate levels of performance. Therefore, our writing process relies on a commitment to developing a shared set of definitions based on consensus. We hope that by taking the time to debate and coming to agreement across a diverse set of programs, the strength of our common measures can indicate real progress towards outcomes we care about. An additional benefit is that these common measures can be adopted and adapted by other agencies and organizations that share similar theories of change. The measures are not without their drawbacks, and we do make tradeoffs as part of our process in order to continue making progress. We know that any measure is necessarily a narrow slice of performance. A slice that may not best represent the unique and remarkable contribution

  10. Long-term outcomes five years after selective dorsal rhizotomy

    Directory of Open Access Journals (Sweden)

    Lagergren Jan

    2008-12-01

    Full Text Available Abstract Background Selective dorsal rhizotomy (SDR is a well accepted neurosurgical procedure performed for the relief of spasticity interfering with motor function in children with spastic cerebral palsy (CP. The goal is to improve function, but long-term outcome studies are rare. The aims of this study were to evaluate long-term functional outcomes, safety and side effects during five postoperative years in all children with diplegia undergoing SDR combined with physiotherapy. Methods This study group consisted of 35 children, consecutively operated, with spastic diplegia, of which 26 were Gross Motor Function Classification System (GMFCS levels III–V. Mean age was 4.5 years (range 2.5–6.6. They were all assessed by the same multidisciplinary team at pre- and at 6, 12, 18 months, 3 and 5 years postoperatively. Clinical and demographic data, complications and number of rootlets cut were prospectively registered. Deep tendon reflexes and muscle tone were examined, the latter graded with the modified Ashworth scale. Passive range of motion (PROM was measured with a goniometer. Motor function was classified according to the GMFCS and measured with the Gross Motor Function Measure (GMFM-88 and derived into GMFM-66. Parent's opinions about the children's performance of skills and activities and the amount of caregiver assistance were measured with Pediatric Evaluation Disability Inventory (PEDI. Results The mean proportion of rootlets cut in S2-L2 was 40%. Muscle tone was immediately reduced in adductors, hamstrings and dorsiflexors (p Conclusion SDR is a safe and effective method for reducing spasticity permanently without major negative side effects. In combination with physiotherapy, in a group of carefully selected and systematically followed young children with spastic diplegia, it provides lasting functional benefits over a period of at least five years postoperatively.

  11. Raised Vaginal Fluid Fibronectin Level Indicates Premature Rupture of Membrane

    Directory of Open Access Journals (Sweden)

    Amrita Bhowmik

    2012-07-01

    Full Text Available Background: Premature rupture of membrane (PROM is one of the common complications of pregnancy that has major impact on fetal and neonatal outcome. It is the commonest clinical event where a normal pregnancy becomes suddenly a high-risk one for mother and fetus or neonate. Objective: The study was undertaken to investigate whether raised fibronectin level in vaginal fluid may indicate premature rupture of membrane. Materials and Methods: This cross sectional study was conducted in the department of Obstetrics and Gynecology in Sir Salimullah Medical College & Mitford Hospital, Dhaka during the period of January 2006 to December 2007. A total of 114 pregnant women with gestational age 28th week up to 40th week were included. Sixty were PROM (Group I and 54 were non-PROM (Group II subjects. Fibronectin in vaginal fluid was measured by an immunochemical reaction by nephelometer. Statistical analysis was done by SPSS version 10.0. Results: The PROM patients had significantly higher concentration of fibronectin (225.77 ± 115.18 ng/mL compared to that in non-PROM subjects (8.04 ± 16.17 ng/mL (p < 0.001. Conclusion: It can be concluded that in cases of unequivocal rupture or intactness of the membranes, the result of the fibronectin test corresponds well with the clinical situation. So fibronectin is a sensitive test for detection of amniotic fluid in the vagina.

  12. Korean Clinic Based Outcome Measure Studies

    Directory of Open Access Journals (Sweden)

    Jongbae Park

    2003-02-01

    Full Text Available Background: Evidence based medicine has become main tools for medical practice. However, conducting a highly ranked in the evidence hierarchy pyramid is not easy or feasible at all times and places. There remains a room for descriptive clinical outcome measure studies with admitting the limit of the intepretation. Aims: Presents three Korean clinic based outcome measure studies with a view to encouraging Korean clinicians to conduct similar studies. Methods: Three studies are presented briefly here including 1 Quality of Life of liver cancer patients after 8 Constitutional acupuncture; 2 Developing a Korean version of Measuring yourself Medical Outcome profile (MYMOP; and 3 Survey on 5 Shu points: a pilot In the first study, we have included 4 primary or secondary liver cancer patients collecting their diagnostic X-ray film and clinical data f개m their hospital, and asked them to fill in the European Organization Research and Treatment of Cancer, Quality of Life Questionnaire before the commencement of the treatment. The acupuncture treatment is set up format but not disclosed yet. The translation and developing a Korean version of outcome measures that is Korean clinician friendly has been sought for MYMOP is one of the most appropriate one. The permission was granted, the translation into Korean was done, then back translated into English only based on the Korean translation by the researcher who is bilingual in both languages. The back translation was compared by the original developer of MYMOP and confirmed usable. In order to test the existence of acupoints and meridians through popular forms of Korean acupuncture regimes, we aim at collecting opinions from 101 Korean clinicians that have used those forms. The questions asked include most effective symptoms, 5 Shu points, points those are least likely to use due to either adverse events or the lack of effectiveness, theoretical reasons for the above proposals, proposing outcome measures

  13. Transabdominal amnioinfusion in preterm premature rupture of membranes.

    Science.gov (United States)

    Singla, Anshuja; Yadav, Poonam; Vaid, Neelam B; Suneja, Amita; Faridi, Mohammad M A

    2010-03-01

    To evaluate the effect of transabdominal amnioinfusion on prolongation of pregnancy, and maternal and neonatal outcomes in preterm premature rupture of membranes (pPROM). We conducted a prospective randomized controlled study of women with pPROM during singleton live pregnancy-between 26 and 33+6weeks-whose amniotic fluid index (AFI) was less than the 5th percentile. The study group underwent transabdominal amnioinfusion at admission and then weekly if their AFI fell below the 5th percentile again. The control group received expectant management. The difference in the mean interval from pPROM to delivery between the groups was not statistically significant. Neonatal and maternal outcomes were significantly improved in the study group compared with the control group (fetal distress [10% vs 37%]; early neonatal sepsis [17% vs 63%]; neonatal mortality [17% vs 63%]; spontaneous delivery [83% vs 53%]; and postpartum sepsis [7% vs 33%]). Transabdominal amnioinfusion reduced fetal distress, early neonatal sepsis, and neonatal mortality. In the study group, more participants delivered spontaneously and there were fewer cases of postpartum sepsis, although the pPROM-delivery interval was not increased.

  14. Investigaciones Terapéuticas en la Lepra: Ensayos con “Promín” o “Promanida'”

    Directory of Open Access Journals (Sweden)

    J. Ignacio Chala H.

    1948-07-01

    Full Text Available Con propósitos de observar, comprobar y valorar los resultados del "Promín"  o “Promanida” en la lepra, lo aplicarnos en un grupo de veintisiete enfermos seleccionados con criterio clínico y de investigación terapéutica. Iniciamos el estudio en julio de 1946. Ninguno de estos casos había sido tratado antes con otros medicamentos preconizados contra la enfermedad. Como lo he dicho en varias ocasiones, solamente teniendo esta precaución y seleccionando los pacientes para la investigación, podrá juzgarse científicamente de la eficacia terapéutica que puedan tener en los distintos tipos de lepra, las drogas aconsejadas para tratar esa enfermedad. Prescindimos de aquellos cases en los cuales, por lo avanzado del mal, los organismos no estaban en condiciones de reaccionar favorablemente con ninguna medicación.

  15. Measurement Properties of Outcome Measures for Vitiligo A Systematic Review

    NARCIS (Netherlands)

    Vrijman, C.; Homan, M.W.L.; Limpens, J.; Veen, W.; Wolkerstorfer, A.; Terwee, C.B.; Spuls, P.I.

    2012-01-01

    Objective: To summarize and critically appraise the evidence on the measurement properties of clinician-, patient-, and observer-reported outcomes, measuring any construct of interest in patients with all types of vitiligo. Data Sources: Electronic databases including PubMed (1948 to July 2011),

  16. Measurement properties of outcome measures for vitiligo. A systematic review

    NARCIS (Netherlands)

    Vrijman, Charlotte; Linthorst Homan, May W.; Limpens, Jacqueline; van der Veen, Wietze; Wolkerstorfer, Albert; Terwee, Caroline B.; Spuls, Phyllis I.

    2012-01-01

    OBJECTIVE To summarize and critically appraise the evidence on the measurement properties of clinician-, patient-, and observer-reported outcomes, measuring any construct of interest in patients with all types of vitiligo. DATA SOURCES Electronic databases including PubMed (1948 to July 2011), OVID

  17. Disability outcome measures in multiple sclerosis clinical trials

    DEFF Research Database (Denmark)

    Cohen, Jeffrey A; Reingold, Stephen C; Polman, Chris H

    2012-01-01

    Many of the available disability outcome measures used in clinical trials of multiple sclerosis are insensitive to change over time, inadequately validated, or insensitive to patient-perceived health status or quality of life. Increasing focus on therapies that slow or reverse disability...... recommend practical refinements. Conversely, although substantial data support the multiple sclerosis functional composite as an alternative measure, changes to its component tests and scoring method are needed. Novel approaches, including the use of composite endpoints, patient-reported outcomes...... progression makes it essential to refine existing measures or to develop new tools. Major changes to the expanded disability status scale should be avoided to prevent the loss of acceptance by regulators as a measure for primary outcomes in trials that provide substantial evidence of effectiveness. Rather, we...

  18. Outcome measurements in major trauma--results of a consensus meeting.

    Science.gov (United States)

    Ardolino, A; Sleat, G; Willett, K

    2012-10-01

    The NHS Outcomes Framework for England has identified recovery from major injury as an important clinical area. At present, there are no established outcome indicators. As more patients survive major trauma, outcomes will need to be measured in terms of morbidity and not mortality alone. To make recommendations for a selection of outcome measures that could be integrated into National Clinical Audit data collection and form part of clinical governance requirements for Regional Trauma Networks (RTNs) and measures by which RTNs are held to account by government. Specific focus was given to acute care and rehabilitation for both adults and children. A Multiprofessional, multidisciplinary expert group reviewed the current evidence on outcome measures for major trauma in the adult and children's populations, informed by a systematic review carried out jointly by the Trauma Audit and Research Network (TARN) and the Cochrane Injuries Group. A structured discussion covered functional and quality of life outcome measures as well as patient experience and indicators such as return to work, education and social dependency. For the adult population the group agreed with the in-hospital performance and hospital discharge measures recommended in the TARN and Cochrane systematic review. Concerning longer-term outcome indicators, the group suggested the use of the Glasgow Outcome Scale - Extended (GOS-E) and European Quality of Life 5D (EQ-5D) with consideration to be given to the World Health Organisation Quality of Life survey (WHO-QoL). For patients who had ongoing inpatient rehabilitation needs the group thought the measurement of the Rehabilitation Complexity Scale (RCS) and Functional Independence Measure (FIM) were important in total brain injury and, the American Spinal Injury Association Impairment Scale (ASIA) and Spinal Cord Independence Measure (SCIM) in spinal cord injury. For children the group recommended the use of the King's Outcome Scale for Childhood Head Injury

  19. Factors influencing the use of outcome measures in physical therapy practice.

    Science.gov (United States)

    Wedge, Frances M; Braswell-Christy, Jennifer; Brown, Cynthia J; Foley, Kathleen T; Graham, Cecilia; Shaw, Sharon

    2012-02-01

    Use of outcome measures in physical therapy practice is central to evaluating the effectiveness of treatment interventions, providing accountability and addressing quality of physical therapy programs. There is limited discussion on barriers and facilitators to using outcome measures in physical therapy practice. The purpose of this study was to identify factors that influence a physical therapist when deciding to use outcome measures in clinical practice. Participants were 21 physical therapists, seven each from skilled nursing facilities, outpatient clinics, and inpatient rehabilitation facilities. A grounded theory approach was used for interview and data collection. Common themes were determined from the data and a theory developed to explain the rationale behind physical therapists' decisions to use or not use outcome measures in clinical practice. Three overlapping themes related to (1) concepts of time, (2) knowledge, and (3) facility culture were indentified as factors influencing the use of outcome measures. A fourth encompassing theme, professionalism, identified the value placed on the use of outcome measures in practice. Data revealed that therapists require more information on the outcome measures available, and this information needs to be easily accessible within the workplace. Therapists value information generated by using outcome measures in the clinical setting, but need information on what measures are available and psychometric properties. Information must be easily accessible and measures easy to use. Newer graduates and recent learners have a foundation in the use of outcome measures, but more needs to be done in the clinic and through continuing education to promote increased use and understanding.

  20. Are the patient-rated wrist evaluation (PRWE) and the disabilities of the arm, shoulder and hand (DASH) questionnaire used in distal radial fractures truly valid and reliable?

    Science.gov (United States)

    Krol, R. G.; Bhandari, M.; Goslings, J. C.; Poolman, R. W.; Scholtes, V. A. B.

    2018-01-01

    Objectives The patient-rated wrist evaluation (PRWE) and the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire are patient-reported outcome measures (PROMs) used for clinical and research purposes. Methodological high-quality clinimetric studies that determine the measurement properties of these PROMs when used in patients with a distal radial fracture are lacking. This study aimed to validate the PRWE and DASH in Dutch patients with a displaced distal radial fracture (DRF). Methods The intraclass correlation coefficient (ICC) was used for test-retest reliability, between PROMs completed twice with a two-week interval at six to eight months after DRF. Internal consistency was determined using Cronbach’s α for the dimensions found in the factor analysis. The measurement error was expressed by the smallest detectable change (SDC). A semi-structured interview was conducted between eight and 12 weeks after DRF to assess the content validity. Results A total of 119 patients (mean age 58 years (sd 15)), 74% female, completed PROMs at a mean time of six months (sd 1) post-fracture. One overall meaningful dimension was found for the PRWE and the DASH. Internal consistency was excellent for both PROMs (Cronbach’s α 0.96 (PRWE) and 0.97 (DASH)). Test-retest reliability was good for the PRWE (ICC 0.87) and excellent for the DASH (ICC 0.91). The SDC was 20 for the PRWE and 14 for the DASH. No floor or ceiling effects were found. The content validity was good for both questionnaires. Conclusion The PRWE and DASH are valid and reliable PROMs in assessing function and disability in Dutch patients with a displaced DRF. However, due to the high SDC, the PRWE and DASH are less useful for individual patients with a distal radial fracture in clinical practice. Cite this article: Y. V. Kleinlugtenbelt, R. G. Krol, M. Bhandari, J. C. Goslings, R. W. Poolman, V. A. B. Scholtes. Are the patient-rated wrist evaluation (PRWE) and the disabilities of the arm, shoulder and

  1. The Popularity of Outcome Measures for Hip and Knee Arthroplasties.

    Science.gov (United States)

    Lovelock, Thomas M; Broughton, Nigel S; Williams, Cylie M

    2018-01-01

    The optimal methods of determining outcomes following hip and knee arthroplasty remain controversial. The objectives of this study were to determine the most frequently used outcome measures in randomized controlled trials (RCT) and study protocols registered with clinical trials registries (CTR) on hip and knee arthroplasty. A systematic search strategy was undertaken to identify the outcome measures used in RCT and CTR following joint arthroplasty. Databases searched included Embase, Ovid MEDLINE (including In-Process), Cochrane Central Register of Controlled Trials, CINAHL Plus, clinicaltrials.gov, ISRCTN registry, and ANZCTR. Differences in the use of outcome measures between RCT and CTR were assessed using logistic regression. There were 291 RCT and 113 CTR on hip arthroplasty and 452 RCT and 184 CTR on knee arthroplasty that met the inclusion criteria. The most popular outcome measures were the Harris Hip Score and the Knee Society Score. Multiple outcome measures were used in greater than 50% of the included studies. The Oxford Hip Score, Oxford Knee Score, EuroQol-5D, and Knee Injury and Osteoarthritis Outcome Score (all P < .001) were used in significantly more CTR than RCT. There is a clear preference for the use of the Harris Hip Score and Knee Society Score, contrary to existing international guidelines and reviews on the topic. Both measures require clinician input, which potentially influences their validity and increases their overall administration cost. Some patient-reported outcome measures, such as the Oxford Hip and Knee Scores, EuroQol-5D, and KOOS, appear to be increasing in popularity. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. Triple osteotomy for the correction of severe hallux valgus deformity: Patient reported outcomes and radiological evaluation.

    Science.gov (United States)

    Booth, Sean; Bhosale, Abhijit; Mustafa, Abubakar; Shenoy, Ravi; Pillai, Anand

    2016-08-01

    Symptomatic Hallux valgus can be treated with metatarsal osteotomy combined with proximal phalangeal osteotomy, however this might not be sufficient to treat severe HV deformities. Fifteen feet in eleven female patients treated with double first metatarsal and proximal phalanx osteotomies without lateral release were prospectively studied and outcome measures including radiological angles and validated patient reported outcome scores collected. Mean radiological follow up was 15 months and PROMs data 17 months. Mean hallux valgus and intermetatarsal angles were corrected from 45 to 24.7° and 18.7 to 7.4° respectively. There was an eight degree recurrence of hallux valgus angle. There was no wound problems, non-unions or evidence of avascular necrosis. The EQ-5D descriptive index showed a non-statistically significant improvement. All three elements of the MOxFQ score showed a statistically significant improvement: Forefoot pain (59-26.8), Walking and Stability (49.9-29.6) and Social Interaction (56.4-33.1) CONCLUSION: Triple osteotomy, without a lateral soft tissue release, leads to good radiological and functional outcomes in those with severe hallux valgus deformity. Patients need to be warned of the recovery time and potential for future metalwork removal. The risk of early recurrence suggests that a lateral release should be included in order to maintain a long lasting correction. Copyright © 2016 Elsevier Ltd. All rights reserved.

  3. Measuring Inclusive Education Outcomes in Alberta, Canada

    Science.gov (United States)

    Loreman, Tim

    2014-01-01

    This study details the results of a review of the academic and public sector literature on measuring inclusive education in large systems. It highlights some outcomes drawn from the international literature on inclusion that might be indicative of the presence and quality of inclusive education in an effort to develop a set of outcomes for…

  4. Obstetric and perinatal outcome in induction of labor compared with expectant management for prelabor rupture of the membranes at term

    International Nuclear Information System (INIS)

    Yaqoob, U.; Mushtaq, R.; Mushtaq, M.

    2015-01-01

    To compare the management outcome of induction of labor with expectant management in patients with term pre labor rupture of membranes (PROM). Study Design: Randomized controlled trial. Place and Duration of Study: This study was conducted in the department of Obstetrics and Gynaecology; Combined Military Hospital Rawalpindi from 25th July 2010 to 25th January 2011. Methods: A total of 384 patients were selected for this study, which were divided into two groups by lottery method. Patients in group A were induced with tablet prostaglandin E2 and group B patients were managed expectantly for 24 hours. The outcome of mothers and neonates was recorded on a pre-designed proforma. Results: The mean duration between PROM to onset of active labor in group A was significantly less (8.4 ± 2.3 hours) as compared to group B in which it was (9.6±2.1 hours) (p = 0.000). The mean duration between PROM to delivery in group A was significantly less in group A (17.4 ± 2.0) versus group B (22.2 ± 2.0 hours) (p = 0.000). The spontaneous vaginal delivery (SVD) rate was considerably higher (p=0.056) in group A in which 161 (83.8%) patients delivered by SVD and 31 (16.1%) patients by LSCS. In group B, 146 (76.0%) patients delivered by SVD and 46 (23.9%) patients by LSCS. In group A, 8 (4.1%) patients developed chorioamnionitis and 13 (6.7%) patients in group B (p = 0.262). In group A there were 178 (92.7%) neonates with APGAR score of > 5 at 1 minute in contrast to 173 (90.1%) in group B with (p = 0.363). Similarly in group A at 5 minutes, there were 178 (92.7%) neonates with APGAR score of > 7 and 173 (90.1%) in group B (p = 0.460). There were 9 (4.6%) cases of neonatal sepsis in group A, in comparison with 12 (6.2%) patients in group B (p = 0.501). Conclusion: The mean duration of labor in induced patients was less as compared to patients with expectant management. (author)

  5. Questionnaires for Measuring Refractive Surgery Outcomes.

    Science.gov (United States)

    Kandel, Himal; Khadka, Jyoti; Lundström, Mats; Goggin, Michael; Pesudovs, Konrad

    2017-06-01

    To identify the questionnaires used to assess refractive surgery outcomes, assess the available questionnaires in regard to their psychometric properties, validity, and reliability, and evaluate the performance of the available questionnaires in measuring refractive surgery outcomes. An extensive literature search was done on PubMed, MEDLINE, Scopus, CINAHL, Cochrane, and Web of Science databases to identify articles that described or used at least one questionnaire to assess refractive surgery outcomes. The information on content quality, validity, reliability, responsiveness, and psychometric properties was extracted and analyzed based on an extensive set of quality criteria. Eighty-one articles describing 27 questionnaires (12 refractive error-specific, including 4 refractive surgery-specific, 7 vision-but-non-refractive, and 8 generic) were included in the review. Most articles (56, 69.1%) described refractive error-specific questionnaires. The Quality of Life Impact of Refractive Correction (QIRC), the Quality of Vision (QoV), and the Near Activity Visual Questionnaire (NAVQ) were originally constructed using Rasch analysis; others were developed using the Classical Test Theory. The National Eye Institute Refractive Quality of Life questionnaire was the most frequently used questionnaire, but it does not provide a valid measurement. The QoV, QIRC, and NAVQ are the three best existing questionnaires to assess visual symptoms, quality of life, and activity limitations, respectively. This review identified three superior quality questionnaires for measuring different aspects of quality of life in refractive surgery. Clinicians and researchers should choose a questionnaire based on the concept being measured with superior psychometric properties. [J Refract Surg. 2017;33(6):416-424.]. Copyright 2017, SLACK Incorporated.

  6. Outcomes assessment in rotator cuff pathology: what are we measuring?

    Science.gov (United States)

    Makhni, Eric C; Steinhaus, Michael E; Morrow, Zachary S; Jobin, Charles M; Verma, Nikhil N; Cole, Brian J; Bach, Bernard R

    2015-12-01

    Assessments used to measure outcomes associated with rotator cuff pathology and after repair are varied. This lack of standardization leads to difficulty drawing comparisons across studies. We hypothesize that this variability in patient-reported outcome measures and objective metrics used in rotator cuff studies persists even in high-impact, peer reviewed journals. All studies assessing rotator cuff tear and repair outcomes in 6 orthopedic journals with a high impact factor from January 2010 to December 2014 were reviewed. Cadaveric and animal studies and those without outcomes were excluded. Outcome measures included range of motion (forward elevation, abduction, external rotation, and internal rotation), strength (in the same 4 planes), tendon integrity imaging, patient satisfaction, and functional assessment scores. Of the 156 included studies, 63% documented range of motion measurements, with 18% reporting range of motion in all 4 planes. Only 38% of studies reported quantitative strength measurements. In 65% of studies, tendon integrity was documented with imaging (38% magnetic resonance imaging/magnetic resonance anrhrogram, 31% ultrasound, and 8% computed tomography arthrogram). Finally, functional score reporting varied significantly, with the 5 most frequently reported scores ranging from 16% to 61% in studies, and 15 of the least reported outcomes were each reported in ≤6% of studies. Significant variability exists in outcomes reporting after rotator cuff tear and repair, making comparisons between clinical studies difficult. Creating a uniformly accepted, validated outcomes tool that assesses pain, function, patient satisfaction, and anatomic integrity would enable consistent outcomes assessment after operative and nonoperative management and allow comparisons across the literature. Copyright © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

  7. Prospective memory, personality, and individual differences.

    Science.gov (United States)

    Uttl, Bob; White, Carmela A; Wong Gonzalez, Daniela; McDouall, Joanna; Leonard, Carrie A

    2013-01-01

    A number of studies investigating the relationship between personality and prospective memory (ProM) have appeared during the last decade. However, a review of these studies reveals little consistency in their findings and conclusions. To clarify the relationship between ProM and personality, we conducted two studies: a meta-analysis of prior research investigating the relationships between ProM and personality, and a study with 378 participants examining the relationships between ProM, personality, verbal intelligence, and retrospective memory. Our review of prior research revealed great variability in the measures used to assess ProM, and in the methodological quality of prior research; these two factors may partially explain inconsistent findings in the literature. Overall, the meta-analysis revealed very weak correlations (rs ranging from 0.09 to 0.10) between ProM and three of the Big Five factors: Openness, Conscientiousness, and Agreeableness. Our experimental study showed that ProM performance was related to individual differences such as verbal intelligence as well as to personality factors and that the relationship between ProM and personality factors depends on the ProM subdomain. In combination, the two studies suggest that ProM performance is relatively weakly related to personality factors and more strongly related to individual differences in cognitive factors.

  8. Vliv motorických schopností a antropometrických měr na úspěšnost v závodech u 11 a 12letých hráček tenisu The influence of tennis motor abilities and anthropometric measures on the competition successfulness of 11 and 12 year-old female tennis players

    Directory of Open Access Journals (Sweden)

    Tjaša Filipčič

    2005-02-01

    Full Text Available Soubor 75 mladých hráček tenisu ve věku 11 a 12 let byl zahrnut do výzkumného projektu s cílem zjistit vliv vybraných antropometrických údajů a tenisových motorických dovedností na úspěšnost v soutěžích mladých tenisových hráčů. Vybrané tenisové motorické proměnné zahrnují: sílu svalů paží a ramen, sílu nohou, opakovanou sílu trupu, rychlost pohybu, rychlost střídavého pohybu rukou, ohebnost zad, hbitost a koordinaci ruka – oko. Výsledky regresní analýzy antropometrických měr odhalují statisticky významné spojení s kritérii proměnných (0,36. Skupina predikčních proměnných může vysvětlit 13% rozdílnost kritérií proměnných. To stejné se aplikuje na tenisové motorické proměnné, u kterých je důležitá hodnota poněkud bližší, dosahuje 0,64, zatímco systém prediktorů vysvětluje 41% rozdílnost kritérií proměnných. Tři proměnné z antropometrických měr (obvod lýtka, tělesná váha, břišní kožní řasa vysvětlují kritérium proměnné se statistickou významností. Mezi již výše zmíněné tenisové motorické proměnné patří běh na 2 400 metrů, který se používá pro měření vytrvalosti v běhu, a běh na 5 metrů, který se používá pro meření rychlosti pohybu. A sample of 75 young female tennis players, aged 11 and 12, was included in a research project aimed at establishing the influence of selected anthropometric measures and tennis motor abilities on the competition successfulness of young tennis players. The selected tennis motor variables include: the muscular power of arms and shoulders, elastic power of the legs, repetitive strength of the trunk, speed of movement, speed of alternative movements with the arm, flexibility of the back, agility, and hand-eye coordination. The results of regression analysis of anthropometric measures reveal a statistically significant connection with the criterion variable (0.36. The system of

  9. Culturally Sensitive and Environment-Friendly Outcome Measures in

    African Journals Online (AJOL)

    Dr Olaleye

    to review research studies on outcome measures that were developed for ... A systematic review of evidence on culturally sensitive and environment- ... Various databases including Google Scholar, PEDro and PubMed were accessed to search for relevant empirical ... utilization of disease-specific, patient-centered outcome.

  10. Cross-cultural and construct validity of the Animated Activity Questionnaire

    DEFF Research Database (Denmark)

    Peter, Wilfred F; Cw de Vet, Henrika; Boers, Maarten

    2017-01-01

    OBJECTIVE: The Animated Activity Questionnaire (AAQ) assesses activity limitations in patients with hip/knee osteoarthritis (HKOA), and consisting video animations of which patients choose the animation that best matches their own performance. The AAQ has shown good validity and reliability......, and a Patient Reported Outcome Measure (PROM) and performance-based tests. RESULTS: Data of 1239 patients were available. Compared to Dutch (n=279), none of the 17 items showed DIF in English (n=202), French (n=193), 1 item showed uniform DIF in Spanish (n=99) and Norwegian (n=62), and 2 items showed uniform...... with the cross-cultural validity between these countries. With regard to construct validity, the correlations with PROM (0.74) and performance-based tests (0.36-0.68) were partly as expected (> 0.60). CONCLUSION: The AAQ, an innovative tool to measure activity limitations that can be placed on the continuum...

  11. The patellofemoral pain and osteoarthritis subscale of the KOOS (KOOS-PF): development and validation using the COSMIN checklist.

    Science.gov (United States)

    Crossley, Kay M; Macri, Erin M; Cowan, Sallie M; Collins, Natalie J; Roos, Ewa M

    2017-03-03

    Patellofemoral pain and osteoarthritis are prevalent and associated with substantial pain and functional impairments. Patient-reported outcome measures (PROMs) are recommended for research and clinical use, but no PROMs are specific for patellofemoral osteoarthritis, and existing PROMs for patellofemoral pain have methodological limitations. This study aimed to develop a new subscale of the Knee injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF), and evaluate its measurement properties. Items were generated using input from 50 patients with patellofemoral pain and/or osteoarthritis and 14 health and medical clinicians. Item reduction was performed using data from patellofemoral cohorts (n=138). We used the COnsesus-based Standards for the selection of health Measurements INstruments guidelines to evaluate reliability, validity, responsiveness and interpretability of the final version of KOOS-PF and other KOOS subscales. From an initial 80 generated items, the final subscale included 11 items. KOOS-PF items loaded predominantly on one factor, pain during activities that load the patellofemoral joint. KOOS-PF had good internal consistency (Cronbach's α 0.86) and adequate test-retest reliability (intraclass correlation coefficient 0.86). Hypothesis testing supported convergent, divergent and known-groups validity. Responsiveness was confirmed, with KOOS-PF demonstrating a moderate correlation with Global Rating of Change scores (r 0.52) and large effect size (Cohen's d 0.89). Minimal detectable change was 2.3 (groups) and 16 (individuals), while minimal important change was 16.4. There were no floor or ceiling effects. The 11-item KOOS-PF, developed in consultation with patients and clinicians, demonstrated adequate measurement properties, and is recommended for clinical and research use in patients with patellofemoral pain and osteoarthritis. © Article author(s) (or their employer(s) unless otherwise stated in the text of

  12. Activin A and its regulatory molecules in placenta and fetal membranes of women with preterm premature rupture of the membranes associated with acute chorioamnionitis.

    Science.gov (United States)

    Torricelli, Michela; Voltolini, Chiara; Novembri, Romina; Bocchi, Caterina; Di Tommaso, Mariarosaria; Severi, Filiberto M; Petraglia, Felice

    2012-11-01

    LABELED PROBLEM: To investigate regulation of activin A and related molecules in placenta/fetal membranes from preterm premature rupture of membranes (pPROM) associated with acute chorioamnionitis (ACA). Tissues were obtained from women with spontaneous preterm deliveries (PTD), pPROM without ACA, pPROM with ACA. Activin A, follistatin, and nodal and cripto mRNA were measured by RT-PCR. Activin A mRNA was up-regulated in tissues from pPROM, in presence or absence of HCA, respect to PTD and in pPROM with ACA respect to pPROM without ACA. Follistatin mRNA expression did not differ between the groups. In placenta, nodal mRNA showed the same trend of activin A, while cripto was down-regulated in pPROM with ACA than other groups. Nodal and cripto were not expressed by fetal membranes. The study shows the involvement of activin A pathway in pPROM with ACA. Further studies will focus on its role in placental immune functions. © 2012 John Wiley & Sons A/S.

  13. Survey of methods of facial palsy documentation in use by members of the Sir Charles Bell Society.

    Science.gov (United States)

    Fattah, Adel Y; Gavilan, Javier; Hadlock, Tessa A; Marcus, Jeffrey R; Marres, Henri; Nduka, Charles; Slattery, William H; Snyder-Warwick, Alison K

    2014-10-01

    Facial palsy manifests a broad array of deficits affecting function, form, and psychological well-being. Assessment scales were introduced to standardize and document the features of facial palsy and to facilitate the exchange of information and comparison of outcomes. The aim of this study was to determine which assessment methodologies are currently employed by those involved in the care of patients with facial palsy as a first step toward the development of consensus on the appropriate assessments for this patient population. Online questionnaire. The Sir Charles Bell Society, a group of professionals dedicated to the care of patients with facial palsy, were surveyed to determine the scales used to document facial nerve function, patient reported outcome measures (PROM), and photographic documentation. Fifty-five percent of the membership responded (n = 83). Grading scales were used by 95%, most commonly the House-Brackmann and Sunnybrook scales. PROMs were used by 58%, typically the Facial Clinimetric Evaluation scale or Facial Disability Index. All used photographic recordings, but variability existed among the facial expressions used. Videography was performed by 82%, and mostly involved the same views as still photography; it was also used to document spontaneous movement and speech. Three-dimensional imaging was employed by 18% of respondents. There exists significant heterogeneity in assessments among clinicians, which impedes straightforward comparisons of outcomes following recovery and intervention. Widespread adoption of structured assessments, including scales, PROMs, photography, and videography, will facilitate communication and comparison among those who study the effects of interventions on this population. © 2014 The American Laryngological, Rhinological and Otological Society, Inc.

  14. Headache Night

    Science.gov (United States)

    Maxwell, Lesli A.

    2007-01-01

    The excesses of the modern prom often require principals to play the roles of police, fashion arbiters, and even parents. In the midst of the 2007 junior and senior prom season, school leaders attest to a mounting list of policies, regulations, and security measures they are enforcing for the year's big social event. Indeed, the prom, a…

  15. Outcome Measures for Clinical Trials in Down Syndrome.

    Science.gov (United States)

    Esbensen, Anna J; Hooper, Stephen R; Fidler, Deborah; Hartley, Sigan L; Edgin, Jamie; d'Ardhuy, Xavier Liogier; Capone, George; Conners, Frances A; Mervis, Carolyn B; Abbeduto, Leonard; Rafii, Michael; Krinsky-McHale, Sharon J; Urv, Tiina

    2017-05-01

    Increasingly individuals with intellectual and developmental disabilities, including Down syndrome, are being targeted for clinical trials. However, a challenge exists in effectively evaluating the outcomes of these new pharmacological interventions. Few empirically evaluated, psychometrically sound outcome measures appropriate for use in clinical trials with individuals with Down syndrome have been identified. To address this challenge, the National Institutes of Health (NIH) assembled leading clinicians and scientists to review existing measures and identify those that currently are appropriate for trials; those that may be appropriate after expansion of age range addition of easier items, and/or downward extension of psychometric norms; and areas where new measures need to be developed. This article focuses on measures in the areas of cognition and behavior.

  16. Understanding paediatric rehabilitation therapists' lack of use of outcome measures.

    Science.gov (United States)

    King, Gillian; Wright, Virginia; Russell, Dianne J

    2011-01-01

    Despite widespread educational and promotional efforts, paediatric rehabilitation therapists still do not systematically or routinely use outcome measures. A review of contextual and psychosocial factors affecting therapists' use of outcome measures was performed, incorporating information from past studies of barriers to therapists' use of measures and more recent information about measure use, knowledge brokering and expert practice. This cumulative and contextual overview provided insights into how many therapists may approach practice. Therapists' beliefs in the importance of establishing effective relationships may lead them to place less value on formal measurement, to adopt a less rigorous and more pragmatic approach to ascertaining whether outcomes are achieved, and to avoid measures that may show little improvement. A relational goal-oriented approach to practice is proposed in which therapists adopt a broader facilitative and educational role with families about the importance of the measurement process.

  17. Vaginal Fluid hCG Levels for Detecting Premature Rupture of Membranes

    Directory of Open Access Journals (Sweden)

    T. Artimani

    2004-04-01

    Full Text Available The aim of this study was to determine whether there is any different in hCG levels of vaginal fluids from normal pregnant women, women with confirmed PROM and with suspected PROM. After irrigating the posterior vaginal fornix with 3 ml of sterile saline and procuring vaginal washing , we measured hCG levels. Samples were analyzed from 38 normal pregnant women , 31 women with confirmed PROM , 28 women with suspected PROM. The mean of vaginal fluid hCG levels of normal pregnant women were 11.2 (0.00-98.6 mIu/ml. That of women with PROM was 140.2 (0.5 , 390.1 and that of women with suspected PROM was 21.5 (0.0 , 143.9. Sensivity was 80%, specility 83% , positive predictive value 73.7% , negative predictive value 88.1% , using a cut-value 20. It was concluded that the hCG level in vaginal fluid is a marker of PROM during third trimester.

  18. Measuring Outcomes for Children Late Placed for Adoption.

    Science.gov (United States)

    Rushton, Alan

    1998-01-01

    Describes the selection of outcome measures used by the Maudsley Family Research team to assess outcomes--across a broad range of developmental dimensions--of permanent placement for children and adolescents. Developed a package of instruments to examine child emotional, cognitive, social, and academic development; attachment; and self-esteem, for…

  19. Identifying an outcome measure to assess the impact of Mobility Dogs.

    Science.gov (United States)

    Mudge, Suzie; Rewi, Dallas; Channon, Alexis

    2017-01-01

    Mobility Dogs® trains dogs to work with people with physical disabilities to increase independence, confidence, self-esteem and participation. Mobility Dogs® seeks to critically evaluate and improve its services as it grows. This study aimed to identify and implement a standardised outcome measure into practice at Mobility Dogs®. Based on the Consolidated Framework for Implementation Research and guided by a steering group of key stakeholders, a three-phase approach was developed to identify and assess an outcome measure. The steering group highlighted the organisation's specific needs, selected participation as the assessment domain and identified core utility requirements of the measure. A comprehensive review of evidence was undertaken to identify and rank potential measures according to the specified needs. Of the seven participation outcome measures that met inclusion criteria, the three highest ranked measures were critically evaluated by the steering group to determine suitability against the organisation's needs. The Impact on Participation and Autonomy (IPA) was selected for implementation into practice at Mobility Dogs®. Use of the IPA is an important first step for Mobility Dogs® to test the benefits of trained service dogs. This process could be replicated by other service dog organisations to identify outcome measures to assess their own services. Implications for Rehabilitation Service dogs (such as Mobility Dogs® in New Zealand) assist people living with physical impairments by performing tasks, however there is limited evidence on outcomes. The process for selecting an appropriate outcome measure for Mobility Dogs® involving partnership between Mobility Dogs® personnel and academics was an effective way to steer the project by determining important properties of the measure, before a search of the literature was undertaken. While the IPA was selected as the most appropriate outcome measure for use at Mobility Dogs®, it was the process that

  20. Measuring Learning Outcomes in Auditing Education

    DEFF Research Database (Denmark)

    Holm, Claus; Steenholdt, Niels

    The ability to provide sensible measures for learning outcomes in accounting education is under increased scrutiny. In this paper we use a learner perspective in auditing education, which reflects that some students taking accounting classes also are provided with on-the-job training in accountin...

  1. Exploring the use of tablet computer-based electronic data capture system to assess patient reported measures among patients with chronic kidney disease: a pilot study.

    Science.gov (United States)

    Wong, Dorothy; Cao, Shen; Ford, Heather; Richardson, Candice; Belenko, Dmitri; Tang, Evan; Ugenti, Luca; Warsmann, Eleanor; Sissons, Amanda; Kulandaivelu, Yalinie; Edwards, Nathaniel; Novak, Marta; Li, Madeline; Mucsi, Istvan

    2017-12-06

    Collecting patient reported outcome measures (PROMs) via computer-based electronic data capture system may improve feasibility and facilitate implementation in clinical care. We report our initial experience about the acceptability of touch-screen tablet computer-based, self-administered questionnaires among patients with chronic kidney disease (CKD), including stage 5 CKD treated with renal replacement therapies (RRT) (either dialysis or transplant). We enrolled a convenience sample of patients with stage 4 and 5 CKD (including patients on dialysis or after kidney transplant) in a single-centre, cross-sectional pilot study. Participants completed validated questionnaires programmed on an electronic data capture system (DADOS, Techna Inc., Toronto) on tablet computers. The primary objective was to evaluate the acceptability and feasibility of using tablet-based electronic data capture in patients with CKD. Descriptive statistics, Fischer's exact test and multivariable logistic regression models were used for data analysis. One hundred and twenty one patients (55% male, mean age (± SD) of 58 (±14) years, 49% Caucasian) participated in the study. Ninety-two percent of the respondents indicated that the computer tablet was acceptable and 79% of the participants required no or minimal help for completing the questionnaires. Acceptance of tablets was lower among patients 70 years or older (75% vs. 95%; p = 0.011) and with little previous computer experience (81% vs. 96%; p = 0.05). Furthermore, a greater level of assistance was more frequently required by patients who were older (45% vs. 15%; p = 0.009), had lower level of education (33% vs. 14%; p = 0.027), low health literacy (79% vs. 12%; p = 0.027), and little previous experience with computers (52% vs. 10%; p = 0.027). Tablet computer-based electronic data capture to administer PROMs was acceptable and feasible for most respondents and could therefore be used to systematically assess PROMs

  2. External cephalic version in premature rupture of membranes: a systematic review.

    Science.gov (United States)

    Quist-Nelson, Johanna; Landers, Kathryn; McCurdy, Rebekah; Berghella, Vincenzo

    2017-09-01

    External cephalic version (ECV) increases the likelihood of a vaginal delivery in patients with breech presentation. Our objective was to determine the rate of cephalic vaginal delivery in women undergoing ECV after PROM. We performed a systematic review of all case reports, case series and clinical trials of patients undergoing an ECV after PROM ≥ 24 weeks. Maternal demographics and outcome data were obtained. The primary outcome was rate of cephalic vaginal delivery. Statistical analysis was performed for continuous outcomes by calculating mean and standard deviations for appropriate variables. The systematic review yielded six papers with 13 case reports and no clinical trials of ECV after PROM. The rate of success to cephalic presentation was 46.1% (six of 13 cases), with a subsequent vaginal delivery rate of 23.1% (three of 13 cases). The rate of umbilical cord prolapse was 33.3% (two of six cases). ECV after PROM has been reported in 13 cases in the literature. For the cases reported, 46.1% of ECV were successful in turning to cephalic position, but only 23.1% resulted in a vaginal delivery. There was a 33.3% incidence of umbilical cord prolapse. Given the high rate of umbilical cord prolapse, it would be imperative to offer an ECV in the setting of PROM only at an institution that has the ability to perform the indicated emergent cesarean delivery and only after appropriate counseling.

  3. Issues in the definition and measurement of drinking outcomes in alcoholism treatment research.

    Science.gov (United States)

    Babor, T F; Longabaugh, R; Zweben, A; Fuller, R K; Stout, R L; Anton, R F; Randall, C L

    1994-12-01

    This article reviews methodological and conceptual issues regarding the choice of drinking outcome measures in alcoholism treatment research. The following issues are discussed: Should drinking outcomes be conceptualized in terms of an underlying unitary disorder, or should provision be made for independent outcomes that cover a wide variety of dimensions? Which drinking outcomes are typically measured in treatment evaluation studies and how are they operationalized? What are the empirical associations among drinking outcome measures? If multiple outcomes are measured, which should be given primary importance? Over what period of time should treatment outcome be evaluated? What procedures can be used to detect, correct or prevent the response bias associated with verbal report methods? Because outcome measures need to fit the hypotheses and practical needs of a particular study, it is unlikely that complete standardization can be achieved across all studies. Nevertheless, given the importance of drinking outcomes and the need for economy, two primary dependent measures are recommended: (1) proportion of available drinking days abstinent; and (2) intensity of drinking, as defined by the total amount consumed (in ounces absolute alcohol) during the follow-up period divided by the number of actual drinking days. This article also proposes a strategy that may help to guide the selection of outcome measures in future research.

  4. Transparent meta-analysis: does aging spare prospective memory with focal vs. non-focal cues?

    Directory of Open Access Journals (Sweden)

    Bob Uttl

    Full Text Available BACKGROUND: Prospective memory (ProM is the ability to become aware of a previously-formed plan at the right time and place. For over twenty years, researchers have been debating whether prospective memory declines with aging or whether it is spared by aging and, most recently, whether aging spares prospective memory with focal vs. non-focal cues. Two recent meta-analyses examining these claims did not include all relevant studies and ignored prevalent ceiling effects, age confounds, and did not distinguish between prospective memory subdomains (e.g., ProM proper, vigilance, habitual ProM (see Uttl, 2008, PLoS ONE. The present meta-analysis focuses on the following questions: Does prospective memory decline with aging? Does prospective memory with focal vs. non-focal cues decline with aging? Does the size of age-related declines with focal vs. non-focal cues vary across ProM subdomains? And are age-related declines in ProM smaller than age-related declines in retrospective memory? METHODS AND FINDINGS: A meta-analysis of event-cued ProM using data visualization and modeling, robust count methods, and conventional meta-analysis techniques revealed that first, the size of age-related declines in ProM with both focal and non-focal cues are large. Second, age-related declines in ProM with focal cues are larger in ProM proper and smaller in vigilance. Third, age-related declines in ProM proper with focal cues are as large as age-related declines in recall measures of retrospective memory. CONCLUSIONS: The results are consistent with Craik's (1983 proposal that age-related declines on ProM tasks are generally large, support the distinction between ProM proper vs. vigilance, and directly contradict widespread claims that ProM, with or without focal cues, is spared by aging.

  5. Redefining Outcome Measurement: A Model for Brief Psychotherapy.

    Science.gov (United States)

    McGuinty, Everett; Nelson, John; Carlson, Alain; Crowther, Eric; Bednar, Dina; Foroughe, Mirisse

    2016-05-01

    The zeitgeist for short-term psychotherapy efficacy has fundamentally shifted away from evidence-based practices to include evidence-informed practices, resulting in an equally important paradigm shift in outcome measurement designed to reflect change in this short-term modality. The present article delineates a short-term psychotherapy structure which defines four fundamental stages that all brief therapies may have in common, and are represented through Cognitive Behavioral Therapy, Solution-Focused Brief Therapy, Narrative Therapy, and Emotion-Focused Therapy. These four theoretical approaches were analyzed via a selected literature review through comparing and contrasting specific and common tasks as they relate to the process of psychotherapy and change. Once commonalities were identified within session, they were categorized or grouped into themes or general stages of change within the parameters of a four to six session model of short-term therapy. Commonalities in therapeutic stages of change may more accurately and uniformly measure outcome in short-term work, unlike the symptom-specific psychometric instruments of longer-term psychotherapy. A systematic framework for evaluating the client and clinician adherence to 20 specific tasks for these four short-term therapies is presented through the newly proposed, Brief Task Acquisition Scale (BTAS). It is further proposed that the client-clinicians' adherence to these tasks will track and ultimately increase treatment integrity. Thus, when the client-clinician relationship tracks and evaluates the three pillars of (1) stage/process change, (2) task acquisition, and (3) treatment integrity, the culmination of these efforts presents a new way of more sensitively measuring outcome in short-term psychotherapy. Data collection is suggested as a first step to empirically evaluate the testable hypotheses suggested within this current model. Copyright © 2015 John Wiley & Sons, Ltd. Key Practitioner Message The

  6. THE OUTCOME OF PREGNANCY IN PATIENTS WITH THREATENED ABORTION

    Directory of Open Access Journals (Sweden)

    Prathap

    2015-10-01

    Full Text Available OBJECTIVE: To assess the Outcome of pregnancy in patients with threatened abortion. METHODS: A Prospective observational study was done on 106 pregnant women with threatened abortion. Out comes in the form of antenatal complications, mode of delivery and postnatal co mplications were noted. Analysis of the data was done using SPSS version 13. RESULTS: In the study of 106 patients 18% had spontaneous abortion. Pre - labour rupture of membranes were seen in 20% of patients and 21% had preterm labour. Threatened abortion di d not affect mode of delivery. PPROM, preterm births were more in women presenting with first trimester bleeding; PIH, PROM, and postpartum complications were more in women presenting beyond 20 weeks gestation though statistically not significant. 13.2% of women had heavy bleeding at admission out of which 50% aborted subsequently – significantly higher than the light bleeding group. CONCLUSION: The overall maternal and perinatal outcome in women with threatened abortion is suboptimal. Women with heavy blee ding are more likely to abort than women with light bleeding. Among the prognostic factors, only the amount of bleeding had significant prognostic accuracy

  7. Evaluating complementary and alternative medicine interventions: in search of appropriate patient-centered outcome measures

    Directory of Open Access Journals (Sweden)

    Mallory Devon

    2006-11-01

    Full Text Available Abstract Background Central to the development of a sound evidence base for Complementary and Alternative Medicine (CAM interventions is the need for valid, reliable and relevant outcome measures to assess whether the interventions work. We assessed the specific needs for a database that would cover a wide range of outcomes measures for CAM research and considered a framework for such a database. Methods The study was a survey of CAM researchers, practitioners and students. An online questionnaire was emailed to the members of the Canadian Interdisciplinary Network for CAM Research (IN-CAM and the CAM Education and Research Network of Alberta (CAMera. The majority of survey questions were open-ended and asked about outcome measures currently used, outcome measures' assessment criteria, sources of information, perceived barriers to finding outcome measures and outcome domains of importance. Descriptive quantitative analysis and qualitative content analysis were used. Results One hundred and sixty-four completed surveys were received. Of these, 62 respondents reported using outcome measures in their CAM research and identified 92 different specific outcomes. The most important barriers were the fact that, for many health concepts, outcome measures do not yet exist, as well as issues related to accessibility of instruments. Important outcome domains identified included physical, psychological, social, spiritual, quality of life and holistic measures. Participants also mentioned the importance of individualized measures that assess unique patient-centered outcomes for each research participant, and measures to assess the context of healing and the process of healing. Conclusion We have developed a preliminary framework that includes all components of health-related outcomes. The framework provides a foundation for a larger, comprehensive collection of CAM outcomes. It fits very well in a whole systems perspective, which requires an expanded set of

  8. Ancillary outcome measures for assessment of individuals with cervical spondylotic myelopathy.

    Science.gov (United States)

    Kalsi-Ryan, Sukhvinder; Singh, Anoushka; Massicotte, Eric M; Arnold, Paul M; Brodke, Darrel S; Norvell, Daniel C; Hermsmeyer, Jeffrey T; Fehlings, Michael G

    2013-10-15

    Narrative review. To identify suitable outcome measures that can be used to quantify neurological and functional impairment in the management of cervical spondylotic myelopathy (CSM). CSM is the leading cause of acquired spinal cord disability, causing varying degrees of neurological impairment which impact on independence and quality of life. Because this impairment can have a heterogeneous presentation, a single outcome measure cannot define the broad range of deficits seen in this population. Therefore, it is necessary to define outcome measures that characterize the deficits with greater validity and sensitivity. This review was conducted in 3 stages. Stage I: To evaluate the current use of outcome measures in CSM, PubMed was searched using the name of the outcome measure and the common abbreviation combined with "CSM" or "myelopathy." Stage II: Having identified a lack of appropriate outcome measures, we constructed criteria by which measures appropriate for assessing the various aspects of CSM could be identified. Stage III: A second literature search was then conducted looking at specified outcomes that met these criteria. All literature was reviewed to determine specificity and psychometric properties of outcomes for CSM. Nurick grade, modified Japanese Orthopaedic Association Scale, visual analogue scale (VAS) for pain, Short Form (36) Health Survey (SF-36), and Neck Disability Index were the most commonly cited measures. The Short-Form 36 Health Survey and Myelopathy Disability Index have been validated in the CSM population with multiple studies, whereas the modified Japanese Orthopaedic Association Scale score, Nurick grade, and European Myelopathy Scale each had only one study assessing psychometric characteristics. No validity, reliability, or responsiveness studies were found for the VAS or Neck Disability Index in the CSM population. We recommend that the modified Japanese Orthopaedic Association Scale, Nurick grade, Myelopathy Disability Index

  9. Fetal MRI for prediction of neonatal mortality following preterm premature rupture of the fetal membranes

    International Nuclear Information System (INIS)

    Messerschmidt, Agnes; Sauer, Alexandra; Pollak, Arnold; Pataraia, Anna; Kasprian, Gregor; Weber, Michael; Prayer, Daniela; Helmer, Hanns; Brugger, Peter C.

    2011-01-01

    Lung MRI volumetrics may be valuable for fetal assessment following early preterm premature rupture of the foetal membranes (pPROM). To evaluate the predictive value of MRI lung volumetrics after pPROM. Retrospective cohort study of 40 fetuses after pPROM in a large, tertiary, perinatal referral center. Fetuses underwent MRI lung volumetrics. Estimated lung volume was expressed as percentage of expected lung volume (our own normal references). Primary outcome was neonatal mortality due to respiratory distress before discharge from hospital. Gestational age range was 16-27 weeks. Estimated-to-expected lung volume was 73% in non-survivors and 102% in survivors (P < 0.05). There were no survivors with a lung volume less than 60% of expected. By logistic regression, mortality could be predicted with a sensitivity of 80%, specificity of 86% and accuracy of 85%. Fetal MR lung volumetrics may be useful for predicting mortality due to respiratory distress in children with early gestational pPROM. (orig.)

  10. Fetal MRI for prediction of neonatal mortality following preterm premature rupture of the fetal membranes

    Energy Technology Data Exchange (ETDEWEB)

    Messerschmidt, Agnes; Sauer, Alexandra; Pollak, Arnold [Medical University of Vienna, Department of Pediatrics and Adolescent Medicine, Vienna (Austria); Pataraia, Anna; Kasprian, Gregor; Weber, Michael; Prayer, Daniela [Medical University of Vienna, Department of Radiology, Vienna (Austria); Helmer, Hanns [Medical University of Vienna, Department of Obstetrics and Maternal-Fetal Medicine, Vienna (Austria); Brugger, Peter C. [Medical University of Vienna, Center of Anatomy and Cell Biology, Vienna (Austria)

    2011-11-15

    Lung MRI volumetrics may be valuable for fetal assessment following early preterm premature rupture of the foetal membranes (pPROM). To evaluate the predictive value of MRI lung volumetrics after pPROM. Retrospective cohort study of 40 fetuses after pPROM in a large, tertiary, perinatal referral center. Fetuses underwent MRI lung volumetrics. Estimated lung volume was expressed as percentage of expected lung volume (our own normal references). Primary outcome was neonatal mortality due to respiratory distress before discharge from hospital. Gestational age range was 16-27 weeks. Estimated-to-expected lung volume was 73% in non-survivors and 102% in survivors (P < 0.05). There were no survivors with a lung volume less than 60% of expected. By logistic regression, mortality could be predicted with a sensitivity of 80%, specificity of 86% and accuracy of 85%. Fetal MR lung volumetrics may be useful for predicting mortality due to respiratory distress in children with early gestational pPROM. (orig.)

  11. Patient-Oriented Eczema Measure (POEM), a core instrument to measure symptoms in clinical trials: a Harmonising Outcome Measures for Eczema (HOME) statement

    NARCIS (Netherlands)

    Spuls, P. I.; Gerbens, L. A. A.; Simpson, E.; Apfelbacher, C. J.; Chalmers, J. R.; Thomas, K. S.; Prinsen, C. A. C.; von Kobyletzki, L. B.; Singh, J. A.; Williams, H. C.; Schmitt, J.

    2017-01-01

    The Harmonising Outcome Measures for Eczema (HOME) initiative has defined four core outcome domains for a core outcome set (COS) to be measured in all atopic eczema (AE) trials to ensure cross-trial comparison: clinical signs, symptoms, quality of life and long-term control. The aim of this paper is

  12. Implant Optimisation for Primary Hip Replacement in Patients over 60 Years with Osteoarthritis: A Cohort Study of Clinical Outcomes and Implant Costs Using Data from England and Wales.

    Directory of Open Access Journals (Sweden)

    Simon S Jameson

    Full Text Available Hip replacement is one of the most commonly performed surgical procedures worldwide; hundreds of implant configurations provide options for femoral head size, joint surface material and fixation method with dramatically varying costs. Robust comparative evidence to inform the choice of implant is needed. This retrospective cohort study uses linked national databases from England and Wales to determine the optimal type of replacement for patients over 60 years undergoing hip replacement for osteoarthritis.Implants included were the commonest brand from each of the four types of replacement (cemented, cementless, hybrid and resurfacing; the reference prosthesis was the cemented hip procedure. Patient reported outcome scores (PROMs, costs and risk of repeat (revision surgery were examined. Multivariable analyses included analysis of covariance to assess improvement in PROMs (Oxford hip score, OHS, and EQ5D index (9159 linked episodes and competing risks modelling of implant survival (79,775 procedures. Cost of implants and ancillary equipment were obtained from National Health Service procurement data.EQ5D score improvements (at 6 months were similar for all hip replacement types. In females, revision risk was significantly higher in cementless hip prostheses (hazard ratio, HR = 2.22, p<0.001, when compared to the reference hip. Although improvement in OHS was statistically higher (22.1 versus 20.5, p<0.001 for cementless implants, this small difference is unlikely to be clinically important. In males, revision risk was significantly higher in cementless (HR = 1.95, p = 0.003 and resurfacing implants, HR = 3.46, p<0.001, with no differences in OHS. Material costs were lowest with the reference implant (cemented, range £1103 to £1524 and highest with cementless implants (£1928 to £4285. Limitations include the design of the study, which is intrinsically vulnerable to omitted variables, a paucity of long-term implant survival data (reflecting the

  13. Measuring outcomes in psychiatry: an inpatient model.

    Science.gov (United States)

    Davis, D E; Fong, M L

    1996-02-01

    This article describes a system for measuring outcomes recently implemented in the department of psychiatry of Baptist Memorial Hospital, a 78-bed inpatient and day treatment unit that represents one service line of a large, urban teaching hospital in Memphis. In June 1993 Baptist Hospital began a 15-month pilot test of PsychSentinel, a measurement tool developed by researchers in the Department of Community Medicine at the University of Connecticut. The hospital identified the following four primary goals for this pilot project: provide data for internal hospital program evaluation, provide data for external marketing in a managed care environment, satisfy requirements of the Joint Commission on Accreditation of Health Care Organizations, and generate studies that add to the literature in psychiatry and psychology. PsychSentinel is based on the standardized diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV). The outcome measure assesses the change in the number of symptoms of psychopathology that occurs between admission and discharge from the hospital. Included in the nonproprietary system are risk adjustment factors, as well as access to a national reference database for comparative analysis purposes. Data collection can be done by trained ancillary staff members, with as much or as little direct physician involvement as desired. The system has proven to be both time effective and cost effective, and it provides important outcome information both at the program level and at the clinician level. After the pilot test, the staff at Baptist Memorial Hospital determined that the system met all initial objectives identified and recently adopted the system as an ongoing measure of quality patient care in the department of psychiatry.

  14. Risk factors for decreased range of motion and poor outcomes in open periarticular elbow fractures.

    Science.gov (United States)

    Dickens, Jonathan F; Wilson, Kevin W; Tintle, Scott M; Heckert, Reed; Gordon, Wade T; D'Alleyrand, Jean-Claude G; Potter, Benjamin K

    2015-04-01

    The purpose of this study was to identify risk factors present at the time of injury that predict poor functional outcomes and heterotopic ossification (HO) in open periarticular elbow fractures. We performed a retrospective review of 136 combat-related open elbow fractures from 2003 to 2010. Patient demographics, injury characteristics, treatment variables, and complications were recorded. Functional outcomes were analyzed to determine range of motion (ROM) and Mayo Elbow Performance Score (MEPS). Secondary outcome measures included the development of HO, return to duty, and revision operation. At a median 2.7 years from injury the median MEPS was 67.8 (range 30-100) with an average ulnohumeral arc motion of 89°. Bipolar fractures, with periarticular fractures on both sides of the elbow and at least one side containing intra-articular extension, were independently associated with decreased ulnohumeral motion (p=0.02) and decreased MEPS (pROM included more severe osseous comminution (p=0.001), and increased time to definitive fixation (p=0.03) and HO (p=0.02). More severe soft tissue injury (Gustilo and Anderson fracture type, p=0.02), peripheral nerve injury (p=0.04), and HO (p=0.03) were independently associated with decreased MEPS. HO developed in 65% (89/136) of extremities and was associated with more severe Orthopaedic Trauma Association (OTA) fracture type (p=0.01) and escalating Gustilo and Anderson fracture classification (p=0.049). In the largest series of open elbow fractures, we identified risk factors that portend a poor clinical outcome and decreased ROM. Bipolar elbow fractures, which have not previously been associated with worse results, are particularly prone to decreased ROM and worse outcomes. Prognostic level IV. Published by Elsevier Ltd.

  15. Populations and outcome measures used in ongoing research in sarcopenia.

    Science.gov (United States)

    Peña Ordóñez, Gloria Gabriela; Bustamante Montes, Lilia Patricia; Ramírez Duran, Ninfa; Sánchez Castellano, Carmen; Cruz-Jentoft, Alfonso J

    2017-08-01

    Sarcopenia research may be hampered by the heterogeneity of populations and outcome measures used in clinical studies. The aim of this study was to describe the inclusion/exclusion criteria and outcome measures used in ongoing research in sarcopenia. All active intervention studies registered in the World Health Organization with the keyword sarcopenia were included. Study design, type of intervention, inclusion/exclusion criteria and outcome measures were registered and classified. In April 2014, 151 studies on sarcopenia were registered in the WHO database. One hundred twenty-three were intervention studies. Most trials (94.3 %) were single centre and randomized (93.5 %), 51.2 % were double blind. Nutritional interventions (36.6 %), physical exercise (12.2 %) or both (19.5 %) were the most common interventions tested. Only 54.4 % included subjects of both genders, and 46.3 % had an upper age limit. Definition of the target populations was heterogeneous, with 57.7 % including healthy subjects and none using recent definitions of sarcopenia. Lifestyle and the degree of physical activity of subjects were not described or considered in most cases (79.7 %). Subjects with cardiovascular, neuropsychiatric or metabolic disorders and those with physical disability were usually excluded. Muscle mass and muscle strength were the primary outcome variables in 28.5 and 29.5 % of studies and physical performance in 19.5 %, but only 4.1 % used the three variables used the three of them. An additional 26.8 % used biological outcome variables. Little information and agreement existed in the way muscle and physical performance parameters were measured. We found a large heterogeneity in trial design, definition of populations and outcome measures in present research.

  16. Measuring treatment outcomes in gambling disorders: a systematic review.

    Science.gov (United States)

    Pickering, Dylan; Keen, Brittany; Entwistle, Gavin; Blaszczynski, Alex

    2018-03-01

    Considerable variation of outcome variables used to measure recovery in the gambling treatment literature has precluded effective cross-study evaluations and hindered the development of best-practice treatment methodologies. The aim of this systematic review was to describe current diffuse concepts of recovery in the gambling field by mapping the range of outcomes and measurement strategies used to evaluate treatments, and to identify more commonly accepted indices of recovery. A systematic search of six academic databases for studies evaluating treatments (psychological and pharmacological) for gambling disorders with a minimum 6-month follow-up. Data from eligible studies were tabulated and analysis conducted using a narrative approach. Guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) were adhered to. Thirty-four studies were reviewed systematically (RCTs = 17, comparative designs = 17). Sixty-three different outcome measures were identified: 25 (39.7%) assessed gambling-specific constructs, 36 (57.1%) assessed non-gambling specific constructs, and two instruments were used across both categories (3.2%). Self-report instruments ranged from psychometrically validated to ad-hoc author-designed questionnaires. Units of measurement were inconsistent, particularly in the assessment of gambling behaviour. All studies assessed indices of gambling behaviour and/or symptoms of gambling disorder. Almost all studies (n = 30; 88.2%) included secondary measures relating to psychiatric comorbidities, psychological processes linked to treatment approach, or global functioning and wellbeing. In research on gambling disorders, the incorporation of broader outcome domains that extend beyond disorder-specific symptoms and behaviours suggests a multi-dimensional conceptualization of recovery. Development of a single comprehensive scale to measure all aspects of gambling recovery could help to facilitate uniform reporting practices

  17. Measuring Population Health Outcomes

    OpenAIRE

    Parrish, R. Gibson

    2010-01-01

    An ideal population health outcome metric should reflect a population's dynamic state of physical, mental, and social well-being. Positive health outcomes include being alive; functioning well mentally, physically, and socially; and having a sense of well-being. Negative outcomes include death, loss of function, and lack of well-being. In contrast to these health outcomes, diseases and injuries are intermediate factors that influence the likelihood of achieving a state of health. On the basis...

  18. Psychometric evaluation of self-report outcome measures for prosthetic applications

    OpenAIRE

    Hafner, Brian J.; Morgan, Sara J.; Askew, Robert L.; Salem, Rana

    2016-01-01

    Documentation of clinical outcomes is increasingly expected in delivery of prosthetic services and devices. However, many outcome measures suitable for use in clinical care and research have not been psychometrically tested with prosthesis users. The aim of this study was to determine test-retest reliability, mode-of-administration (MoA) equivalence, standard error of measurement (SEM), and minimal detectable change (MDC) of standardized, self-report instruments that assess constructs of impo...

  19. The International Dermatology Outcome Measures initiative as applied to psoriatic disease outcomes

    DEFF Research Database (Denmark)

    Gottlieb, Alice B; Armstrong, April W; Christensen, Robin

    2014-01-01

    In the United States, access to care is the number one issue facing our patients with dermatological conditions. In part, this is because we do not have outcome measures that are useful in clinical practice and available in databases where payers and governmental agencies can compare the performa...

  20. Using Delphi methodology in the development of a new patient-reported outcome measure for stroke survivors with visual impairment.

    Science.gov (United States)

    Hepworth, Lauren R; Rowe, Fiona J

    2018-02-01

    The aim of this study was to ascertain what items stroke survivors and stroke care professionals think are important when assessing quality of life for stroke survivors with visual impairment for inclusion in the new patient-reported outcome measure. A reactive Delphi process was used in a three-round electronic-based survey. The items presented consisted of 62 items originally sourced from a systematic review of existing vision-related quality of life instruments and stroke survivor interviews, reduced and refined following a ranking exercise and pilot with stroke survivors with visual impairment. Stakeholders (stroke survivors/clinicians) were invited to take part in the process. A consensus definition of ≥70% was decided a priori. Participants were asked to rank importance on a 9-point scale and categorize the items by relevance to types of visual impairment following stroke or not relevant. Analysis of consensus, stability, and agreement was conducted. In total, 113 participants registered for the Delphi survey of which 47 (41.6%) completed all three rounds. Response rates to the three rounds were 78/113 (69.0%), 61/76 (81.3%), and 49/64 (76.6%), respectively. The participants included orthoptists (45.4%), occupational therapists (44.3%), and stroke survivors (10.3%). Consensus was reached on 56.5% of items in the three-round process, all for inclusion. A consensus was reached for 83.8% in the categorization of items. The majority (82.6%) of consensus were for relevant to 'all visual impairment following stroke'; two items were deemed 'not relevant'. The lack of item reduction achieved by this Delphi process highlights the need for additional methods of item reduction in the development of a new PROM for visual impairment following stroke. These results will be considered alongside Rasch analysis to achieve further item reduction. However, the Delphi survey remains important as it provides clinical and patient insight into each item rather than purely relying

  1. Measuring and communicating meaningful outcomes in neonatology: A family perspective.

    Science.gov (United States)

    Janvier, Annie; Farlow, Barbara; Baardsnes, Jason; Pearce, Rebecca; Barrington, Keith J

    2016-12-01

    Medium- and long-term outcomes have been collected and described among survivors of neonatal intensive care units for decades, for a number of purposes: (1) quality control within units, (2) comparisons of outcomes between NICUs, (3) clinical trials (whether an intervention improves outcomes), (4) end-of-life decision-making, (5) to better understand the effects of neonatal conditions and/or interventions on organs and/or long-term health, and finally (6) to better prepare parents for the future. However, the outcomes evaluated have been selected by investigators, based on feasibility, availability, cost, stability, and on what investigators consider to be important. Many of the routinely measured outcomes have major limitations: they may not correlate well with long-term difficulties, they may artificially divide continuous outcomes into dichotomous ones, and may have no clear relationship with quality of life and functioning of children and their families. Several investigations, such as routine term cerebral resonance imaging for preterm infants, have also not yet been shown to improve the outcome of children nor their families. In this article, the most common variables used in neonatology as well as some variables which are rarely measured but may be of equal importance for families are presented. The manner in which these outcomes are communicated to families will be examined, as well as recommendations to optimize communication with parents. Copyright © 2016 Elsevier Inc. All rights reserved.

  2. Relationship outcomes as measurement criteria to assist communication strategists to manage organisational relationships

    Directory of Open Access Journals (Sweden)

    E. Botha

    2011-06-01

    Full Text Available Nonfinancial assets like relationships are increasingly important to managers. Communication managers in particular are focusing on measuring and managing organisational relationships as a means to quantify the return on investment (ROI of public relations and communication strategies. Measuring relationships offers communication managers a way to evaluate its contribution to the organisation. A commonly agreed upon definition of these relationships, however, does not exist. If we consider communication management is a managerial function, it must first refine its instruments of measurement. This study looks at the three-stage model of organisational relationships (relationship antecedents, maintenance strategies and relationship outcomes proposed by Grunig & Huang (2000 to firstly review the development of the model. Secondly, the study takes an in-depth look at each relationship outcomes of trust, commitment, satisfaction and control mutuality. Lastly, we assess the reliability and validity of the use of current relationship outcome measures through a survey of 154 organisational relationships. Previous studies that have utilized these outcomes in the measurement of organisational relationships do not discuss the possible interaction (or relationship among these outcomes. This study contributes to current literature by both providing an improved framework for the measurement of relationship outcomes and hypothesizing about how these outcomes interact with one another. It also discusses the managerial implications of managing relationships through the constant measurement of trust, commitment, satisfaction and control mutuality

  3. Development and psychometric properties of the client's assessment of treatment scale for supported accommodation (CAT-SA).

    Science.gov (United States)

    Sandhu, Sima; Killaspy, Helen; Krotofil, Joanna; McPherson, Peter; Harrison, Isobel; Dowling, Sarah; Arbuthnott, Maurice; Curtis, Sarah; King, Michael; Leavey, Gerard; Shepherd, Geoff; Priebe, Stefan

    2016-02-25

    Patient-Reported Outcome Measures (PROMs) are important for evaluating mental health services. Yet, no specific PROM exists for the large and diverse mental health supported accommodation sector. We aimed to produce and validate a PROM specifically for supported accommodation services, by adapting the Client's Assessment of Treatment Scale (CAT) and assessing its psychometric properties in a large sample. Focus groups with service users in the three main types of mental health supported accommodation services in the United Kingdom (residential care, supported housing and floating outreach) were conducted to adapt the contents of the original CAT items and assess the acceptability of the modified scale (CAT-SA). The CAT-SA was then administered in a survey to service users across England. Internal consistency was assessed using Cronbach's alpha. Convergent validity was tested through correlations with subjective quality of life and satisfaction with accommodation, as measured by the Manchester Short Assessment of Quality of Life (MANSA). All seven original items of the CAT were regarded as relevant to appraisals of mental health supported accommodation services, with only slight modifications to the wording required. In the survey, data were obtained from 618 clients. The internal consistency of the CAT-SA items was 0.89. Mean CAT-SA scores were correlated with the specific accommodation item on the MANSA (r s  = 0.37, p ˂ .001). The content of the CAT-SA has relevance to service users living in mental health supported accommodation. The findings from our large survey show that the CAT-SA is acceptable across different types of supported accommodation and suggest good psychometric properties. The CAT-SA appears a valid and easy to use PROM for service users in mental health supported accommodation services.

  4. High-risk human papillomavirus infection is associated with premature rupture of membranes.

    Science.gov (United States)

    Cho, GeumJoon; Min, Kyung-Jin; Hong, Hye-Ri; Kim, SuhngWook; Hong, Jin-Hwa; Lee, Jae-Kwan; Oh, Min-Jeong; Kim, HaiJoong

    2013-09-06

    Human papillomavirus (HPV) is known to be more prevalent in spontaneous abortions than in elective terminations of pregnancy. More recently, placental infection with HPV was shown to be associated with spontaneous preterm delivery. However, no study has evaluated the prevalence of HPV infection in pregnant Korean females and its association with adverse pregnancy outcomes. We conducted a cross-sectional study of 311 females who gave birth at Korea University Medical Center. Our sample included 45 preterm deliveries, 50 cases of premature rupture of the membranes (PROM), 21 preeclampsia cases, and 8 gestational diabetes mellitus (GDM) patients. We used the Hybrid Capture II system to detect high-risk (HR)-HPV infection at six weeks postpartum. The prevalence of HR-HPV infection was 14.1%. Women with HR-HPV infection had a higher incidence of PROM than those without HR-HPV. HR-HPV infection was associated with an increased risk of PROM (OR, 2.380; 95% CI, 1.103-5.134). The prevalence of preterm delivery, preeclampsia, or GDM was not different between the two groups. We observed a high prevalence of HR-HPV infection in pregnant women. Moreover, HR-HPV infection was associated with a risk of PROM at term. Further studies are needed to evaluate mechanisms by which HR-HPV infection induces PROM.

  5. Outcome measures for adult critical care: a systematic review.

    Science.gov (United States)

    Hayes, J A; Black, N A; Jenkinson, C; Young, J D; Rowan, K M; Daly, K; Ridley, S

    2000-01-01

    1. To identify generic and disease specific measures of impairment, functional status and health-related quality of life that have been used in adult critical care (intensive and high-dependency care) survivors. 2. To review the validity, reliability and responsiveness of the measures in adult critical care survivors. 3. To consider the implications for future policy and to make recommendations for further methodological research. 4. To review what is currently known of the outcome of adult critical care. Searches of electronic databases (MEDLINE, EMBASE, CINAHL, PsycLIT, The Cochrane Library and SIGLE) from 1970 to August 1998. Manual searches of five journals (1985-98) not indexed in electronic databases and relevant conference proceedings (1993-98). Reference lists of six existing reviews, plus snowballing from reference lists of all relevant articles identified. Randomised trials, non-randomised trials (cohort studies) and case series that included data on outcomes after discharge from adult (16 years and over) critical care. If reported, the following data were extracted from each paper: patient characteristics (age, gender, severity of illness, diagnostic category) number of patients eligible for study, follow-up period, number of deaths before follow-up, number and proportion of survivors included in follow-up method of presentation of outcome data - proportion normal as defined by reference values, or aggregate value (e.g. mean or median), or aggregate values plus an indication of variance (e.g. standard deviation or inter-quartile range). Evidence for three measurement properties was sought for each outcome measure that had been used in at least two studies - their validity, reliability and responsiveness in adult critical care. If the authors did not report these aspects explicitly, an attempt was made to use the data provided to provide these measurement properties. For measures that were used in at least ten studies, information on actual reported

  6. Patient profiling can identify patients with adult spinal deformity (ASD) at risk for conversion from nonoperative to surgical treatment: initial steps to reduce ineffective ASD management.

    Science.gov (United States)

    Passias, Peter G; Jalai, Cyrus M; Line, Breton G; Poorman, Gregory W; Scheer, Justin K; Smith, Justin S; Shaffrey, Christopher I; Burton, Douglas C; Fu, Kai-Ming G; Klineberg, Eric O; Hart, Robert A; Schwab, Frank; Lafage, Virginie; Bess, Shay

    2018-02-01

    Non-operative management is a common initial treatment for patients with adult spinal deformity (ASD) despite reported superiority of surgery with regard to outcomes. Ineffective medical care is a large source of resource drain on the health system. Characterization of patients with ASD likely to elect for operative treatment from non-operative management may allow for more efficient patient counseling and cost savings. This study aimed to identify deformity and disability characteristics of patients with ASD who ultimately convert to operative treatment compared with those who remain non-operative and those who initially choose surgery. A retrospective review was carried out. A total of 510 patients with ASD (189 non-operative, 321 operative) with minimum 2-year follow-up comprised the patient sample. Oswestry Disability Index (ODI), Short-Form 36 Health Assessment (SF-36), Scoliosis Research Society questionnaire (SRS-22r), and spinopelvic radiographic alignment were the outcome measures. Demographic, radiographic, and patient-reported outcome measures (PROMs) from a cohort of patients with ASD prospectively enrolled into a multicenter database were evaluated. Patients were divided into three treatment cohorts: Non-operative (NON=initial non-operative treatment and remained non-operative), Operative (OP=initial operative treatment), and Crossover (CROSS=initial non-operative treatment with subsequent conversion to operative treatment). NON and OP groups were propensity score-matched (PSM) to CROSS for baseline demographics (age, body mass index, Charlson Comorbidity Index). Time to crossover was divided into early (1 year). Outcome measures were compared across and within treatment groups at four time points (baseline, 6 weeks, 1 year, and 2 years). Following PSM, 118 patients were included (NON=39, OP=38, CROSS=41). Crossover rate was 21.7% (41/189). Mean time to crossover was 394 days. All groups had similar baseline sagittal alignment, but CROSS had larger

  7. A tool for evaluating the potential for cost-effective outcomes measurement

    Directory of Open Access Journals (Sweden)

    Somasekhar MM

    2012-04-01

    Full Text Available Melinda M Somasekhar1, Alfred Bove2, Chris Rausch1, James Degnan3, Cathy T King1, Arnold Meyer11The Albert J Finestone, MD, Office for Continuing Medical Education, 2Section of Cardiology, Temple University School of Medicine, Philadelphia, PA, USA; 3Measurement and Research Center, Temple University, Philadelphia, PA, USAAbstract: Cost related to higher-level outcomes measurement is often very high. However, the cost burden is felt even more by smaller, less well-funded continuing medical education (CME programs. It is possible to overcome financial and participant-related barriers to measuring Level 6 outcomes, which are patient health outcomes. The Temple University School of Medicine’s Office for Continuing Medical Education developed a sequential tool for attaining cost-effective outcomes measurement for determining the likelihood of a CME intervention to produce significant changes in physician performance. The appropriate selection of the CME topic and specific practice change indictors drive this tool. This tool walks providers through a simple YES or NO decision-making list that guides them toward an accurate prediction of potential programmatic outcomes. Factors considered during the decision-making process include whether: (a the intended change(s will have a substantial impact on current practice; (b the intended practice change(s are well supported by clinical data, specialty organization/government recommendations, expert opinion, etc; (c the potential change(s affects a large population; (d external factors, such as system pressures, media pressures, financial pressures, patient pressures, safety pressures, etc, are driving this intended change in performance; (e there is a strong motivation on the part of physicians to implement the intended change(s; and (f the intended change(s is relatively easy to implement within any system of practice. If each of these questions can be responded to positively, there is a higher likelihood

  8. Cost-effectiveness analysis in severe mental illness : Outcome measures selection

    NARCIS (Netherlands)

    Stant, A. Dennis; Buskens, Erik; Jenner, Jack A.; Wiersma, Durk; TenVergert, Elisabeth M.

    Background: Most economic evaluations conducted in mental healthcare did not include widely recommended preference-based health outcomes like the QALY (Quality-Adjusted Life Years). Instead, studies have mainly been designed as cost-effectiveness analyses that include single outcome measures aimed

  9. Microbial load of umbilical cord blood Ureaplasma species and Mycoplasma hominis in preterm prelabor rupture of membranes.

    Science.gov (United States)

    Kacerovsky, Marian; Pliskova, Lenka; Menon, Ramkumar; Kutova, Radka; Musilova, Ivana; Maly, Jan; Andrys, Ctirad

    2014-11-01

    To evaluate Ureaplasma species and M. hominis DNA in the umbilical cord blood and its correlation with its microbial load in the amniotic fluid, as a measure of microbial burden in fetal inflammatory response and neonatal outcome in pregnancies complicated by preterm prelabor rupture of membranes (pPROM). A retrospective study of 158 women with singleton pregnancies complicated by pPROM between 24(0/7) and 36(6/7) weeks was conducted. Amniotic fluid was obtained from all women by transabdominal amniocentesis, and umbilical cord blood was obtained by venipuncture from umbilical cords immediately after the delivery of the neonates. The Ureaplasma species and M. hominis DNA was quantitated using absolute quantification techniques. Ureaplasma species and M. hominis DNA was identified in 9% of the umbilical cord blood samples. No correlation between the amniotic fluid and umbilical cord blood microbial load was observed. The presence of Ureaplasma species and M. hominis DNA in the umbilical cord blood had no impact on short-term neonatal morbidity. A high microbial load of genital mycoplasma Ureaplasma species DNA in the umbilical cord in pregnancies complicated by pPROM is not associated with a high fetal inflammatory response and is therefore not associated with serious neonatal morbidity.

  10. Outcome Measurement in Nursing: Imperatives, Ideals, History, and Challenges

    Science.gov (United States)

    Jones, Terry L

    2016-05-31

    Nurses have a social responsibility to evaluate the effect of nursing practice on patient outcomes in the areas of health promotion; injury and illness prevention; and alleviation of suffering. Quality assessment initiatives are hindered by the paucity of available data related to nursing processes and patient outcomes across these three domains of practice. Direct care nurses are integral to self-regulation for the discipline as they are the best source of information about nursing practice and patient outcomes. Evidence supports the assumption that nurses do contribute to prevention of adverse events but there is insufficient evidence to explain how nurses contribute to these and/or other patient outcomes. The purposes of this article are to examine the imperatives, ideal conditions, history, and challenges related to effective outcome measurement in nursing. The article concludes with recommendations for action to move quality assessment forward, such as substantial investment to support adequate documentation of nursing practice and patient outcomes.

  11. A Binomial Test of Group Differences with Correlated Outcome Measures

    Science.gov (United States)

    Onwuegbuzie, Anthony J.; Levin, Joel R.; Ferron, John M.

    2011-01-01

    Building on previous arguments for why educational researchers should not provide effect-size estimates in the face of statistically nonsignificant outcomes (Robinson & Levin, 1997), Onwuegbuzie and Levin (2005) proposed a 3-step statistical approach for assessing group differences when multiple outcome measures are individually analyzed…

  12. Measuring Learning Outcomes. A Learner Perspective in Auditing Education

    DEFF Research Database (Denmark)

    Holm, Claus; Steenholdt, Niels

    2000-01-01

    The ability to provide sensible measures for learning outcomes in accounting education is under increased scrutiny. In this paper we use a learner perspective in auditing education which reflects that some students taking accounting classes also are provided with on-the-job training in accounting...... for students taking a graduate auditing course reflect prior accounting work experience for some students and undergraduate accounting coursework experience for all students. This paper extends prior research on the role of declarative and procedural knowledge in performing auditing tasks. Measuring learning...... suggested by Robert M. Gagné. An instrument was developed to measure differences regarding learning outcomes in the context of an auditing course by posing a broad set of questions testing declarative knowledge and the full range of intellectual skills from discrimination to the use of higher...

  13. Outcome Measurement in the Treatment of Spasmodic Dysphonia: A Systematic Review of the Literature.

    Science.gov (United States)

    Rumbach, Anna; Aiken, Patrick; Novakovic, Daniel

    2018-04-11

    The aim of this review was to systematically identify all available studies reporting outcomes measures to assess treatment outcomes for people with spasmodic dysphonia (SD). Full-text journal articles were identified through searches of PubMed, Embase, CINAHL, and Cochrane databases and hand searching of journals. A total of 4,714 articles were retrieved from searching databases; 1,165 were duplicates. Titles and abstracts of 3,549 were screened, with 171 being selected for full-text review. During full-text review, 101 articles were deemed suitable for inclusion. An additional 24 articles were identified as suitable for inclusion through a hand search of reference lists. Data were extracted from 125 studies. A total of 220 outcome measures were identified. Considered in reference to the World Health Organization International Classification of Functioning, Disability and Health (ICF), the majority of outcomes were measured at a Body Function level (n = 212, 96%). Outcomes that explored communication and participation in everyday life and attitudes toward communication (ie, activity and participation domains) were infrequent (n = 8; 4%). Quality of life, a construct not measured within the ICF, was also captured by four outcome measures. No instruments evaluating communication partners' perspectives or burden/disability were identified. The outcome measures used in SD treatment studies are many and varied. The outcome measures identified predominately measure constructs within the Body Functions component of the ICF. In order to facilitate data synthesis across trials, the development of a core outcome set is recommended. Crown Copyright © 2018. Published by Elsevier Inc. All rights reserved.

  14. Patient-Oriented Eczema Measure (POEM), a core instrument to measure symptoms in clinical trials: a Harmonising Outcome Measures for Eczema (HOME) statement

    OpenAIRE

    Spuls, Ph.I.; Gerbens, L.A.A.; Simpson, E.; Apfelbacher, C.J.; Chalmers, J.R.; Thomas, K.S.; Prinsen, C.A.C.; Kobyletzki, L.B. von; Singh, J.A.; Williams, Hywel C.; Schmitt, J.

    2017-01-01

    Background: The Harmonising Outcome Measures for Eczema (HOME) initiative has defined four core outcome domains for a core outcome set (COS) to be measured in all atopic eczema (AE) trials to ensure cross-trial comparison: clinical signs, symptoms, quality of life and longterm control.\\ud Objectives: The aim of this paper is to report on the consensus process that was used to select the core instrument to consistently assess symptoms in all future AE trials.\\ud Methods: Following the HOME roa...

  15. Associations between nine family dinner frequency measures and child weight, dietary and psychosocial outcomes

    Science.gov (United States)

    Fulkerson, Jayne A.; Friend, Sarah E.; Neumark-Sztainer, Dianne

    2015-01-01

    Background Family meal frequency has been consistently and significantly associated with positive youth dietary and psychosocial outcomes but less consistently associated with weight outcomes. Family meal frequency measurement has varied widely and it is unclear how this variation may impact relationships with youth weight, dietary, and psychosocial outcomes. Objective This study assesses how five parent/caregiver-reported and four child-reported family dinner frequency measures correlate with each other and are associated with health-related outcomes. Design/Participants This secondary, cross-sectional analysis uses baseline, parent/caregiver (n=160) and 8–12 year old child (n=160) data from the Healthy Home Offerings via the Mealtime Environment (HOME) Plus trial (collected 2011–2012). Data were obtained from objective measurements, dietary recall interviews, and psychosocial surveys. Outcome measures Outcomes included child body mass index z-scores (BMIz), fruit, vegetable and sugar-sweetened beverage intake, dietary quality (Healthy Eating Index-2010 [HEI-2010]), family connectedness, and meal conversations. Statistical analyses performed Pearson correlations and general linear models were used to assess associations between family dinner frequency measures and outcomes. Results All family dinner frequency measures had comparable means and were correlated within and across parent/caregiver- and child-reporters (r=0.17–0.94, pdinner frequency measures were significantly associated with BMIz scores and 100% were significantly associated with fruit/vegetable intake and HEI-2010. In adjusted models, most significant associations with dietary and psychosocial outcomes remained but associations with child BMIz remained significant only for parent/caregiver- (β±SE= −0.07±0.03; pdinner frequency measures asking about ‘sitting and eating’ dinner. Conclusions In spite of phrasing variations in family dinner frequency measures (e.g., which family members

  16. Clinical and patient-reported outcomes of zirconia-based implant fixed dental prostheses: Results of a prospective case series 5 years after implant placement.

    Science.gov (United States)

    Spies, Benedikt Christopher; Witkowski, Siegbert; Vach, Kirstin; Kohal, Ralf-Joachim

    2018-01-01

    To evaluate the clinical and patient-reported outcome of all-ceramic zirconia implant supported fixed dental prostheses (FDPs) 5 years after implant installation. Thirteen patients were treated with two terminally placed one-piece zirconia implants for a three-unit FDP each. The FDPs consisted of a CAD/CAM-fabricated zirconia framework over-pressed with a fluor-apatite veneering ceramic and were adhesively cemented. Survival and success were assessed by applying modified US Public Health Service (USPHS) criteria and preparation of Kaplan-Meier (KM) plots. Alpha and Bravo ratings were accepted for success (among others including small area veneer chippings and occlusal roughness), whereas Charlie ratings allowing for intra-oral correction (e.g., polishing) were accepted for survival. Furthermore, patient-reported outcome measures (PROMs) were analyzed with the help of visual analogue scales (VAS). Wilcoxon matched-pairs signed-rank test (USPHS criteria) and linear mixed models (PROMs) were used to evaluate time effects on response variables. All patients were available 61.8 ± 1.1 months after implant installation (53.6 ± 3.1 months after final prosthesis insertion). FDP survival was 100%. Significant incidence of veneer chipping (p = .0096) and occlusal roughness (p = .0019) was observed. Charlie rated extent of both phenomena resulted in a KM success estimate of 38.5% (95% CI: 14.1%-62.8%; seven FDPs with obvious roughness, three of them with extended veneer chipping). Compared with the pre-treatment assessments (30%-81% of satisfaction), all surveys at prosthetic delivery showed significantly improved VAS scores (66%-93%; p ≤ .038), except for speech (p = .341). Concerning function, esthetics and self-esteem, no decrease in satisfaction could be observed until the end of follow-up (90%-96%; p ≥ .057), whereas perception of sense (92%) and speech (95%) increased over time (p ≤ .030). Occurrence of technical complications did not correlate

  17. Network meta-analysis of multiple outcome measures accounting for borrowing of information across outcomes.

    Science.gov (United States)

    Achana, Felix A; Cooper, Nicola J; Bujkiewicz, Sylwia; Hubbard, Stephanie J; Kendrick, Denise; Jones, David R; Sutton, Alex J

    2014-07-21

    Network meta-analysis (NMA) enables simultaneous comparison of multiple treatments while preserving randomisation. When summarising evidence to inform an economic evaluation, it is important that the analysis accurately reflects the dependency structure within the data, as correlations between outcomes may have implication for estimating the net benefit associated with treatment. A multivariate NMA offers a framework for evaluating multiple treatments across multiple outcome measures while accounting for the correlation structure between outcomes. The standard NMA model is extended to multiple outcome settings in two stages. In the first stage, information is borrowed across outcomes as well across studies through modelling the within-study and between-study correlation structure. In the second stage, we make use of the additional assumption that intervention effects are exchangeable between outcomes to predict effect estimates for all outcomes, including effect estimates on outcomes where evidence is either sparse or the treatment had not been considered by any one of the studies included in the analysis. We apply the methods to binary outcome data from a systematic review evaluating the effectiveness of nine home safety interventions on uptake of three poisoning prevention practices (safe storage of medicines, safe storage of other household products, and possession of poison centre control telephone number) in households with children. Analyses are conducted in WinBUGS using Markov Chain Monte Carlo (MCMC) simulations. Univariate and the first stage multivariate models produced broadly similar point estimates of intervention effects but the uncertainty around the multivariate estimates varied depending on the prior distribution specified for the between-study covariance structure. The second stage multivariate analyses produced more precise effect estimates while enabling intervention effects to be predicted for all outcomes, including intervention effects on

  18. Surrogacy assessment using principal stratification when surrogate and outcome measures are multivariate normal.

    Science.gov (United States)

    Conlon, Anna S C; Taylor, Jeremy M G; Elliott, Michael R

    2014-04-01

    In clinical trials, a surrogate outcome variable (S) can be measured before the outcome of interest (T) and may provide early information regarding the treatment (Z) effect on T. Using the principal surrogacy framework introduced by Frangakis and Rubin (2002. Principal stratification in causal inference. Biometrics 58, 21-29), we consider an approach that has a causal interpretation and develop a Bayesian estimation strategy for surrogate validation when the joint distribution of potential surrogate and outcome measures is multivariate normal. From the joint conditional distribution of the potential outcomes of T, given the potential outcomes of S, we propose surrogacy validation measures from this model. As the model is not fully identifiable from the data, we propose some reasonable prior distributions and assumptions that can be placed on weakly identified parameters to aid in estimation. We explore the relationship between our surrogacy measures and the surrogacy measures proposed by Prentice (1989. Surrogate endpoints in clinical trials: definition and operational criteria. Statistics in Medicine 8, 431-440). The method is applied to data from a macular degeneration study and an ovarian cancer study.

  19. Association between maternal urinary chromium and premature rupture of membranes in the Healthy Baby Cohort study in China.

    Science.gov (United States)

    Huang, Sha; Xia, Wei; Li, Yuanyuan; Zhang, Bin; Zhou, Aifen; Zheng, Tongzhang; Qian, Zhengmin; Huang, Zheng; Lu, Shi; Chen, Zhong; Wang, Youjie; Pan, Xinyun; Huo, Wenqian; Jin, Shuna; Jiang, Yangqian; Xu, Shunqing

    2017-11-01

    Chromium exposure from increasing industrial releases has become a threat for pregnant women due to the potential health effects on vulnerable embryos. Previous studies have suggested that maternal chromium exposure is associated with adverse birth outcomes, but no epidemiological research has been conducted to examine the relationship between chromium exposure and premature rupture of membranes (PROM). This study aimed at investigating the association of maternal urinary chromium exposure levels with PROM and was performed with 5408 pregnant women recruited from 2012 to 2014 in the city of Wuhan, China. Maternal urinary chromium collected before labor was adjusted with creatinine, and its association with PROM was evaluated using logistic regression. Each one unit increase in the natural logarithm transformed maternal urinary chromium concentration (μg/g creatinine), an odds ratio (OR) of 1.47 [95% confidence interval (CI): 1.36, 1.58] for PROM was observed. Compared to the lowest tertile of maternal urinary chromium, PROM was positively correlated with increased urinary levels of chromium (adjusted OR = 1.42; 95% CI: 1.09, 1.84 for the medium tertile; adjusted OR = 2.77; 95% CI: 2.18, 3.52 for the highest tertile). Additionally, the association of chromium with PROM appeared to be more significant among male infants (adjusted OR = 3.52; 95% CI: 2.51, 4.94 for the highest tertile) than female infants (adjusted OR = 2.16; 95% CI: 1.52, 3.06 for the highest tertile) (p for interaction = 0.05). Our large birth cohort showed an association between maternal urinary chromium levels and PROM, and the association may differ by infant gender. Further studies from different populations are needed to confirm the observed association. Copyright © 2017 Elsevier Ltd. All rights reserved.

  20. Psychometric validation of patient-reported outcome measures assessing chronic constipation

    Directory of Open Access Journals (Sweden)

    Nelson LM

    2014-09-01

    Full Text Available Lauren M Nelson,1 Valerie SL Williams,1 Sheri E Fehnel,1 Robyn T Carson,2 James MacDougall,3 Mollie J Baird,3 Stavros Tourkodimitris,2 Caroline B Kurtz,3 Jeffrey M Johnston31RTI Health Solutions, Durham, NC, USA; 2Forest Research Institute, Jersey City, NJ, USA; 3Ironwood Pharmaceuticals, Cambridge, MA, USABackground: Measures assessing treatment outcomes in previous CC clinical trials have not met the requirements described in the US Food and Drug Administration's guidance on patient-reported outcomes.Aim: Psychometric analyses using data from one Phase IIb study and two Phase III trials of linaclotide for the treatment of chronic constipation (CC were conducted to document the measurement properties of patient-reported CC Symptom Severity Measures.Study methods: Each study had a multicenter, randomized, double-blind, placebo-controlled, parallel-group design, comparing placebo to four doses of oral linaclotide taken once daily for 4 weeks in the Phase IIb dose-ranging study (n=307 and to two doses of linaclotide taken once daily for 12 weeks in the Phase III trials (n=1,272. The CC Symptom Severity Measures addressing bowel function (Bowel Movement Frequency, Stool Consistency, Straining and abdominal symptoms (Bloating, Abdominal Discomfort, Abdominal Pain were administered daily using interactive voice-response system technology. Intraclass correlations, Pearson correlations, factor analyses, F-tests, and effect sizes were computed.Results: The CC Symptom Severity Measures demonstrated satisfactory test–retest reliability and construct validity. Factor analyses indicated one factor for abdominal symptoms and another for bowel symptoms. Known-groups F-tests substantiated the discriminating ability of the CC Symptom Severity Measures. Responsiveness statistics were moderate to strong, indicating that these measures are capable of detecting change.Conclusion: In large studies of CC patients, linaclotide significantly improved abdominal and

  1. Physical outcome measures for conductive and mixed hearing loss treatment: A systematic review.

    Science.gov (United States)

    Johansson, M L; Tysome, J R; Hill-Feltham, P; Hodgetts, W E; Ostevik, A; McKinnon, B J; Monksfield, P; Sockalingam, R; Wright, T

    2018-05-07

    The number of potential options for rehabilitation of patients with conductive or mixed hearing loss is continually expanding. To be able to inform patients and other stakeholders there is a need to identify and develop patient-centred outcomes for treatment of hearing loss. To identify outcome measures in the physical core area used when reporting the outcome after treatment of conductive and mixed hearing loss in adult patients. Systematic review. Systematic review of literature related to reported physical outcome measures after treatment of mixed or conductive hearing loss without restrictions regarding type of intervention, treatment or device. Any measure reporting the physical outcome after treatment or intervention of mixed or conductive hearing loss was sought and categorised. The physical outcomes measures that had been extracted were then grouped into domains. The literature search resulted in the identification of 1,434 studies, of which 153 were selected for inclusion in the review. The majority (57%) of papers reported results from middle ear surgery, with the remainder reporting results from either bone conduction hearing devices or middle ear implants. Outcomes related to complications were categorised into 17 domains, whereas outcomes related to treatment success was categorised in 22 domains. The importance of these domains to patients and other stakeholders needs to be further explored in order to establish which of these domains are most relevant to interventions for conductive or mixed hearing loss. This will allow us to then assess which outcomes measures are most suitable for inclusion in the core set This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  2. The Aphasia Communication Outcome Measure (ACOM): Dimensionality, Item Bank Calibration, and Initial Validation

    Science.gov (United States)

    Hula, William D.; Doyle, Patrick J.; Stone, Clement A.; Hula, Shannon N. Austermann; Kellough, Stacey; Wambaugh, Julie L.; Ross, Katherine B.; Schumacher, James G.; St. Jacque, Ann

    2015-01-01

    Purpose: The purpose of this study is to investigate the structure and measurement properties of the Aphasia Communication Outcome Measure (ACOM), a patient-reported outcome measure of communicative functioning for persons with aphasia. Method: Three hundred twenty-nine participants with aphasia responded to 177 items asking about communicative…

  3. The National Outcomes Measurement System for Pediatric Speech-Language Pathology

    Science.gov (United States)

    Mullen, Robert; Schooling, Tracy

    2010-01-01

    Purpose: The American Speech-Language-Hearing Association's (ASHA's) National Outcomes Measurement System (NOMS) was developed in the late 1990s. The primary purpose was to serve as a source of data for speech-language pathologists (SLPs) who found themselves called on to provide empirical evidence of the functional outcomes associated with their…

  4. Measuring Outcome in the Treatment of Cocaine Dependence

    Science.gov (United States)

    Crits-Christoph, Paul; Gallop, Robert; Gibbons, Mary Beth Connolly; Sadicario, Jaclyn S.; Woody, George

    2015-01-01

    Background Little in known about the extent to which outcome measures used in studies of the treatment of cocaine dependence are associated with longer-term use and with broader measures of clinical improvement. The current study examined reductions in use, and abstinence-oriented measures, in relation to functioning and longer-term clinical benefits in the treatment of cocaine dependence. Methods Overall drug use, cocaine use, and functioning in a number of addiction-related domains for 487 patients diagnosed with DSM-IV cocaine dependence and treated with one of four psychosocial interventions in the NIDA Cocaine Collaborative Treatment Study were assessed monthly during 6 months of treatment and at 9, 12, 15, and 18 month follow-up. Results Measures of during-treatment reduction in use were moderately correlated with drug and cocaine use measures 12 months, but showed non-significant or small correlations with measures of functioning at 12 months. Highest correlations were evident for abstinence measures (maximum consecutive days abstinence and completely abstinent) during treatment in relation to sustained (3 month) abstinence at 12 months. Latent class analysis of patterns of change over time revealed that most patients initially (months 1 to 4 of treatment) either became abstinent immediately or continued to use every month. Over the couse of follow-up, patients either maintained abstinence or used regularly – intermittent use was less common. Conclusions There were generally small associations between various measures of cocaine use and longer-term clinical benefits, other than abstinence was associated with continued abstinence. No one method of measuring outcome of treatment of cocaine dependence appears superior to others. PMID:26366427

  5. Use of standardized outcome measures in physical therapist practice: perceptions and applications.

    Science.gov (United States)

    Jette, Diane U; Halbert, James; Iverson, Courtney; Miceli, Erin; Shah, Palak

    2009-02-01

    Standardized instruments for measuring patients' activity limitations and participation restrictions have been advocated for use by rehabilitation professionals for many years. The available literature provides few recent reports of the use of these measures by physical therapists in the United States. The primary purpose of this study was to determine: (1) the extent of the use of standardized outcome measures and (2) perceptions regarding their benefits and barriers to their use. A secondary purpose was to examine factors associated with their use among physical therapists in clinical practice. The study used an observational design. A survey questionnaire comprising items regarding the use and perceived benefits and barriers of standardized outcome measures was sent to 1,000 randomly selected members of the American Physical Therapy Association (APTA). Forty-eight percent of participants used standardized outcome measures. The majority of participants (>90%) who used such measures believed that they enhanced communication with patients and helped direct the plan of care. The most frequently reported reasons for not using such measures included length of time for patients to complete them, length of time for clinicians to analyze the data, and difficulty for patients in completing them independently. Use of standardized outcome measures was related to specialty certification status, practice setting, and the age of the majority of patients treated. The limitations included an unvalidated survey for data collection and a sample limited to APTA members. Despite more than a decade of development and testing of standardized outcome measures appropriate for various conditions and practice settings, physical therapists have some distance to go in implementing their use routinely in most clinical settings. Based on the perceived barriers, alterations in practice management strategies and the instruments themselves may be necessary to increase their use.

  6. Are current psychometric tools suitable for measuring outcomes of diabetes education?

    DEFF Research Database (Denmark)

    Eigenmann, C. A.; Colagiuri, R.; Skinner, T. C.

    2009-01-01

    Aims To critically appraise the suitability, validity, reliability, feasibility and sensitivity to change of available psychometric tools for measuring the education outcomes identified in the (Australian) National Consensus on Outcomes and Indicators for Diabetes Patient Education. Methods Poten...

  7. Achieving Minimum Clinically Important Difference in Oxford Knee Score and Short Form-36 Physical Component Summary Is Less Likely with Single-Radius Compared with Multiradius Total Knee Arthroplasty in Asians.

    Science.gov (United States)

    Lee, Wu Chean; Bin Abd Razak, Hamid Rahmatullah; Allen, John Carson; Chong, Hwei Chi; Tan, Hwee Chye Andrew

    2018-04-10

    Single-radius (SR) and multiradius (MR) total knee arthroplasties (TKAs) have produced similar outcomes, albeit most studies originate from Western nations. There are known knee kinematic differences between Western and Asian patients after TKA. The aim of this study is to compare the short-term patient-reported outcome measures (PROMs) of SR-TKA versus MR-TKA in Asians. Registry data of 133 SR-TKA versus 363 MR-TKA by a single surgeon were analyzed. Preoperative and 2-year postoperative range of motion (ROM) and PROMs were compared with Student's t -test and Mann-Whitney U-test. Logistic regression model was used to evaluate the odds of SR-TKA or MR-TKA achieving the minimum clinically important difference (MCID) of studied outcomes. Patients in both groups had similar age (65.7 ± 7.6 vs. 65.8 ± 8.2 years; p  = 0.317), gender proportion (71% females vs. 79% females; p  = 0.119), and ethnic distribution (80% Chinese vs. 84% Chinese; p  = 0.258). Preoperatively, there were no statistically significant differences between both groups for ROM, Knee Society Score (KSS), Oxford Knee Score (OKS), and Short Form (SF)-36 scores. At 2 years, all outcomes were statistically similar or failed to achieve a difference of MCID. Controlling for all preoperative variables, SR-TKA has significantly lower odds of achieving MCID for OKS (odds ratio [OR]: 0.275, 95% confidence interval [CI]: 0.114-0.663; p  = 0.004) and SF-36 Physical Component Summary (PCS) (OR: 0.547; 95% CI: 0.316-0.946; p  = 0.031) compared with MR-TKA. In conclusion, there are no significant differences in the absolute PROMs between SR-TKA and MR-TKA at 2 years following TKA in Asians. However, SR-TKA has significantly lower odds of achieving the MCID for OKS and SF-36 PCS. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  8. A randomized trial of Foley Bulb for Labor Induction in Premature Rupture of Membranes in Nulliparas (FLIP).

    Science.gov (United States)

    Amorosa, Jennifer M H; Stone, Joanne; Factor, Stephanie H; Booker, Whitney; Newland, Meredith; Bianco, Angela

    2017-09-01

    In premature rupture of membranes (PROM), the risk of chorioamnionitis increases with increasing duration of membrane rupture. Decreasing the time from PROM to delivery is associated with lower rates of maternal infection. The American College of Obstetricians and Gynecologists suggests that all women with PROM who do not have a contraindication to vaginal delivery have their labor induced instead of being managed expectantly. Although the use of oxytocin for labor induction has been demonstrated to decrease the time to delivery compared with expectant management, no studies have evaluated the effectiveness of cervical ripening with a Foley bulb to additionally decrease the time to delivery. To determine whether simultaneous use of an intracervical Foley bulb and oxytocin decreases time from induction start to delivery in nulliparous patients with PROM compared with the use of oxytocin alone. A randomized trial was conducted from August 2014 to February 2016 that compared the use of concurrent Foley bulb/oxytocin vs oxytocin alone in nulliparous patients ≥34 weeks' gestational undergoing labor induction for PROM. Our primary outcome was time from induction to delivery. Secondary outcomes were mode of delivery, tachysystole, chorioamnionitis, postpartum hemorrhage, Apgar scores, and admission to the neonatal intensive care unit. A total of 128 women were randomized. Baseline characteristics were similar between groups. We found no difference in induction-to-delivery time between women induced with concurrent Foley bulb/oxytocin vs oxytocin alone (median time 13.0 hours [interquartile 10.7, 16.1] compared with 10.8 hours [interquartile range 7.8, 16.6], respectively, P = .09). There were no significant differences in mode of delivery, rates of postpartum hemorrhage, chorioamnionitis, or epidural use. Both groups had similar rates of tachysystole as well as total oxytocin dose. There were no differences in neonatal birth weight, Apgar scores, cord gases, or

  9. HIP AND GLENOHUMERAL PASSIVE RANGE OF MOTION IN COLLEGIATE SOFTBALL PLAYERS

    Science.gov (United States)

    Plummer, Hillary; Brambeck, Allison

    2016-01-01

    Background and Purpose Range of motion deficits at the hip and glenohumeral joint (GHJ) may contribute to the incidence of injury in softball players. With injury in softball players on the rise, softball related studies in the literature are important. The purpose of this study was to examine hip and GHJ passive range of motion (PROM) patterns in collegiate softball players. Hypothesis It was hypothesized that the position players would exhibit significantly different PROM patterns than pitchers. Additionally, position players would exhibit significantly different side-to-side differences in PROM for both the hip and GHJ compared to pitchers. Study Design Prospective cohort study. Methods Forty-nine collegiate softball players (19.63 ± 1.15 years; 170.88 ± 8.08 cm; 72.96 ± 19.41 kg) participated. Passive hip and GHJ internal (IR) and external rotation (ER) measures were assessed. Glenohumeral PROM was measured with the participants supine with the arm abducted to 90 °. The measurements were recorded when the scapula began to move or a firm capsular end-feel was achieved. The hip was positioned in 90 ° of flexion and passively rotated until a capsular end-feel was achieved. Total PROM was calculated by taking the sum of IR and ER for both the hip and GHJ. Results No significant side-to-side PROM differences were observed in pitchers, at the GHJ or hip joint. Position players throwing side hip IR was significantly greater than the non-throwing side hip (p = 0.002). The non-throwing side hip had significantly greater ER compared to the throwing side hip (p = 0.002). When examining side-to-side differences at the GHJ, IR was significantly greater in the non-throwing shoulder (p = 0.047). No significant differences in total range of motion of the hip and GHJ were observed. Conclusion In the current study, position players displayed side-to-side differences in hip and GHJ IR PROM while no statistically significant differences were

  10. Psychometric evaluation of self-report outcome measures for prosthetic applications.

    Science.gov (United States)

    Hafner, Brian J; Morgan, Sara J; Askew, Robert L; Salem, Rana

    2016-01-01

    Documentation of clinical outcomes is increasingly expected in delivery of prosthetic services and devices. However, many outcome measures suitable for use in clinical care and research have not been psychometrically tested with prosthesis users. The aim of this study was to determine test-retest reliability, mode-of-administration (MoA) equivalence, standard error of measurement (SEM), and minimal detectable change (MDC) of standardized, self-report instruments that assess constructs of importance to people with lower limb loss. Prosthesis users (n = 201) were randomly assigned to groups based on MoA (i.e., paper, electronic, or mixed-mode). Participants completed two surveys 2 to 3 d apart. Instruments included the Prosthetic Limb Users Survey of Mobility, Prosthesis Evaluation Questionnaire-Mobility Subscale, Activities-Specific Balance Confidence Scale, Quality of Life in Neurological Conditions-Applied Cognition/General Concerns, Patient-Reported Outcomes Measurement Information System Profile, and Socket Comfort Score. Intraclass correlation coefficients indicated all instruments are appropriate for group-level comparisons and select instruments are suitable for individual-level applications. Several instruments showed evidence of possible floor and ceiling effects. All were equivalent across MoAs. SEM and MDC were quantified to facilitate interpretation of outcomes and change scores. These results can enhance clinicians' and researchers' ability to select, apply, and interpret scores from instruments administered to prosthesis users.

  11. Measuring social inclusion--a key outcome in global mental health.

    Science.gov (United States)

    Baumgartner, Joy Noel; Burns, Jonathan K

    2014-04-01

    Social inclusion is increasingly recognized as a key outcome for evaluating global mental health programmes and interventions. Whereas social inclusion as an outcome is not a new concept in the field of mental health, its measurement has been hampered by varying definitions, concepts and instruments. To move the field forward, this paper reviews the currently available instruments which measure social inclusion and are reported in the literature, realizing that no single measure will be appropriate for all studies or contexts. A systematic literature search of English language peer-reviewed articles published through February 2013 was undertaken to identify scales specifically developed to measure social inclusion or social/community integration among populations with mental disorders. Five instruments were identified through the search criteria. The scales are discussed in terms of their theoretical underpinnings, domains and/or key items and their potential for use in global settings. Whereas numerous reviewed abstracts discussed mental health and social inclusion or social integration, very few were concerned with direct measurement of the construct. All identified scales were developed in high-income countries with limited attention paid to how the scale could be adapted for cross-cultural use. Social inclusion is increasingly highlighted as a key outcome for global mental health policies and programmes, yet its measurement is underdeveloped. There is need for a global cross-cultural measure that has been developed and tested in diverse settings. However, until that need is met, some of the scales presented here may be amenable to adaptation.

  12. Does the duration of symptoms influence outcome in patients with sciatica undergoing micro-discectomy and decompressions?

    Science.gov (United States)

    Pitsika, Marina; Thomas, Eleanor; Shaheen, Sabeena; Sharma, Himanshu

    2016-04-01

    Early surgical treatment for back and leg pain secondary to disc herniation has been associated with very good outcomes. However, there are conflicting data on the role of surgical treatment in case of prolonged radicular symptomatology. We aimed to evaluate whether the duration of symptoms at presentation affects the subjective outcome. This is a retrospective review of prospectively collected data from a single surgeon including micro-discectomies and lateral recess decompressions in patients younger than 60 years old using patient medical notes, radiology imaging, operation notes, and Patient Reported Outcome Measures (PROMS) including Oswestry Disability Index (ODI), visual analogue scale for back pain and leg pain (VAS-BP and VAS-LP). The final follow-up was carried out through postal questionnaire or telephone consultation. Demographic information, duration of symptoms, type and incidence of complications, length of hospital stay, and follow-up were analyzed. Data were categorized into four subgroups: symptoms 0≥6 months, 6 months≥1 year, 1 year≥2 years, and >2 years. A clinically significant result was an average improvement of 2 or more points in the VAS and of 20% and over in the ODI. The level of statistical significance was 2 years (VAS-LP 4.77±3.61, VAS-BP 3.54±3.43, ODI 28.36±20.93). The length of hospital stay and complication rate was comparable between groups. Average follow-up was 15.69 months. Our study showed significant improvement in patients with symptoms beyond 1 as well as 2 years since onset, and surgery is a viable option in selected patients. Copyright © 2016 Elsevier Inc. All rights reserved.

  13. Analysis And Comments On The Consultative Document: International Framework For Liquidity Risk Measurement, Standards And Monitoring

    OpenAIRE

    Jacques Prefontaine; Jean Desrochers; Lise Godbout

    2010-01-01

    The market turmoil that began in mid-2007 re-emphasized the importance of liquidity to the functioning of financial markets and the banking sector. In December 2009, the Basel Committee on Banking Supervision (BCBS) of the Bank for International Settlements (BIS) released a consultative document entitled: “International Framework for Liquidity Risk Measurement, Standards and Monitoring”. Interested parties were invited to provide written comments by April 16th 2010. Given our interest in prom...

  14. CONSIDER - Core Outcome Set in IAD Research: study protocol for establishing a core set of outcomes and measurements in incontinence-associated dermatitis research.

    Science.gov (United States)

    Van den Bussche, Karen; De Meyer, Dorien; Van Damme, Nele; Kottner, Jan; Beeckman, Dimitri

    2017-10-01

    This study protocol describes the methodology for the development of a core set of outcomes and a core set of measurements for incontinence-associated dermatitis. Incontinence is a widespread disorder with an important impact on quality of life. One of the most common complications is incontinence-associated dermatitis, resulting from chemical and physical irritation of the skin barrier, triggering inflammation and skin damage. Managing incontinence-associated dermatitis is an important challenge for nurses. Several interventions have been assessed in clinical trials, but heterogeneity in study outcomes complicates the comparability and standardization. To overcome this challenge, the development of a core outcome set, a minimum set of outcomes and measurements to be assessed in clinical research, is needed. A project team, International Steering Committee and panelists will be involved to guide the development of the core outcome set. The framework of the Harmonizing Outcomes Measures for Eczema roadmap endorsed by Cochrane Skin Group Core Outcomes Set Initiative, is used to inform the project design. A systematic literature review, interviews to integrate the patients' perspective and a consensus study with healthcare researchers and providers using the Delphi procedure will be performed. The project was approved by the Ethics review Committee (April 2016). This is the first project that will identify a core outcome set of outcomes and measurements for incontinence-associated dermatitis research. A core outcome set will reduce possible reporting bias, allow results comparisons and statistical pooling across trials and strengthen evidence-based practice and decision-making. This project has been registered in the Core Outcome Measures in Effectiveness Trials (COMET) database and is part of the Cochrane Skin Group Core Outcomes Set Initiative (CSG-COUSIN). © 2016 John Wiley & Sons Ltd.

  15. Worse patient-reported outcome after lateral approach than after anterior and posterolateral approach in primary hip arthroplasty

    Science.gov (United States)

    Havelin, Leif I; Furnes, Ove; Baste, Valborg; Nordsletten, Lars; Hovik, Oystein; Dimmen, Sigbjorn

    2014-01-01

    Background The surgical approach in total hip arthroplasty (THA) is often based on surgeon preference and local traditions. The anterior muscle-sparing approach has recently gained popularity in Europe. We tested the hypothesis that patient satisfaction, pain, function, and health-related quality of life (HRQoL) after THA is not related to the surgical approach. Patients 1,476 patients identified through the Norwegian Arthroplasty Register were sent questionnaires 1–3 years after undergoing THA in the period from January 2008 to June 2010. Patient-reported outcome measures (PROMs) included the hip disability osteoarthritis outcome score (HOOS), the Western Ontario and McMaster Universities osteoarthritis index (WOMAC), health-related quality of life (EQ-5D-3L), visual analog scales (VAS) addressing pain and satisfaction, and questions about complications. 1,273 patients completed the questionnaires and were included in the analysis. Results Adjusted HOOS scores for pain, other symptoms, activities of daily living (ADL), sport/recreation, and quality of life were significantly worse (p < 0.001 to p = 0.03) for the lateral approach than for the anterior approach and the posterolateral approach (mean differences: 3.2–5.0). These results were related to more patient-reported limping with the lateral approach than with the anterior and posterolateral approaches (25% vs. 12% and 13%, respectively; p < 0.001). Interpretation Patients operated with the lateral approach reported worse outcomes 1–3 years after THA surgery. Self-reported limping occurred twice as often in patients who underwent THA with a lateral approach than in those who underwent THA with an anterior or posterolateral approach. There were no significant differences in patient-reported outcomes after THA between those who underwent THA with a posterolateral approach and those who underwent THA with an anterior approach. PMID:24954494

  16. Use of the measure your medical outcome profile (MYMOP2 and W-BQ12 (Well-Being outcomes measures to evaluate chiropractic treatment: an observational study

    Directory of Open Access Journals (Sweden)

    Polus Barbara I

    2011-03-01

    Full Text Available Abstract Background The objective was to assess the use of the Measure Yourself Medical Outcome Profile (MYMOP2 and W-BQ12 well-being questionnaire for measuring clinical change associated with a course of chiropractic treatment. Methods Chiropractic care of the patients involved spinal manipulative therapy (SMT, mechanically assisted techniques, soft tissue therapy, and physiological therapeutic devices. Outcome measures used were MYMOP2 and the Well-Being Questionnaire 12 (W-BQ12. Results Statistical and clinical significant changes were demonstrated with W-BQ12 and MYMOP2. Conclusions The study demonstrated that MYMOP2 was responsive to change and may be a useful instrument for assessing clinical changes among chiropractic patients who present with a variety of symptoms and clinical conditions.

  17. Measuring Student Learning Outcomes Using the SALG Instrument

    Science.gov (United States)

    Scholl, Kathleen; Olsen, Heather M.

    2014-01-01

    U.S. higher education institutions are being called to question their central nature, priorities, and functions, with prominent and unprecedented attention being given to accountability and the measurement of student learning outcomes. As higher education evolves in how it assesses student learning and leisure studies and recreation departments…

  18. [Improving care for cleft lip and palate patients: uniform and patient-orientated outcome measures].

    Science.gov (United States)

    Haj, M; de Gier, H H W; van Veen-van der Hoek, M; Versnel, S L; van Adrichem, L N; Wolvius, E B; Hazelzet, J A; Koudstaal, M J

    2018-02-01

    The quality of care for patients with cleft lip and palate is extremely variable across the world. Treatment protocols differ and methods of data registration are not uniform. Improving this care by means of comparative research is challenging. The best treatment programmes can be identified by uniformly registering patient-orientated outcomes and comparing the outcomes with those of other treatment centres. That knowledge can be used to improve one's own care. An international team consisting of specialists and cleft lip and palate patients has developed a set of outcome measures that are considered by patients to be most important. This team is coordinated by the International Consortium of Health Outcomes Measurement (ICHOM). The cleft lip and palate outcome set can be used by all centres worldwide in following up on cleft lip and palate patients. In the Erasmus Medical Centre in Rotterdam, the 'Zorgmonitor Schisis' (Care Monitor Cleft Lip and Palate) has been built, an application in which these outcome measures are collected at fixed times. Implementing this set of outcome measures in other cleft lip and palate treatment centres and using the outcomes as (inter)national benchmarks will result in transparency and the improvement of the treatment of cleft lip and palate worldwide.

  19. Implementation of learning outcome attainment measurement system in aviation engineering higher education

    Science.gov (United States)

    Salleh, I. Mohd; Mat Rani, M.

    2017-12-01

    This paper aims to discuss the effectiveness of the Learning Outcome Attainment Measurement System in assisting Outcome Based Education (OBE) for Aviation Engineering Higher Education in Malaysia. Direct assessments are discussed to show the implementation processes that become a key role in the successful outcome measurement system. A case study presented in this paper involves investigation on the implementation of the system in Aircraft Structure course for Bachelor in Aircraft Engineering Technology program in UniKL-MIAT. The data has been collected for five semesters, starting from July 2014 until July 2016. The study instruments used include the report generated in Learning Outcomes Measurements System (LOAMS) that contains information on the course learning outcomes (CLO) individual and course average performance reports. The report derived from LOAMS is analyzed and the data analysis has revealed that there is a positive significant correlation between the individual performance and the average performance reports. The results for analysis of variance has further revealed that there is a significant difference in OBE grade score among the report. Independent samples F-test results, on the other hand, indicate that the variances of the two populations are unequal.

  20. A tool for evaluating the potential for cost-effective outcomes measurement.

    Science.gov (United States)

    Somasekhar, Melinda M; Bove, Alfred; Rausch, Chris; Degnan, James; King, Cathy T; Meyer, Arnold

    2012-01-01

    Cost related to higher-level outcomes measurement is often very high. However, the cost burden is felt even more by smaller, less well-funded continuing medical education (CME) programs. It is possible to overcome financial and participant-related barriers to measuring Level 6 outcomes, which are patient health outcomes. The Temple University School of Medicine's Office for Continuing Medical Education developed a sequential tool for attaining cost-effective outcomes measurement for determining the likelihood of a CME intervention to produce significant changes in physician performance. The appropriate selection of the CME topic and specific practice change indictors drive this tool. This tool walks providers through a simple YES or NO decision-making list that guides them toward an accurate prediction of potential programmatic outcomes. Factors considered during the decision-making process include whether: (a) the intended change(s) will have a substantial impact on current practice; (b) the intended practice change(s) are well supported by clinical data, specialty organization/government recommendations, expert opinion, etc; (c) the potential change(s) affects a large population; (d) external factors, such as system pressures, media pressures, financial pressures, patient pressures, safety pressures, etc, are driving this intended change in performance; (e) there is a strong motivation on the part of physicians to implement the intended change(s); and (f) the intended change(s) is relatively easy to implement within any system of practice. If each of these questions can be responded to positively, there is a higher likelihood that the intended practice-related change(s) will occur. Such change can be measured using a simpler and less costly methodology.

  1. The art and science of using routine outcome measurement in mental health benchmarking.

    Science.gov (United States)

    McKay, Roderick; Coombs, Tim; Duerden, David

    2014-02-01

    To report and critique the application of routine outcome measurement data when benchmarking Australian mental health services. The experience of the authors as participants and facilitators of benchmarking activities is augmented by a review of the literature regarding mental health benchmarking in Australia. Although the published literature is limited, in practice, routine outcome measures, in particular the Health of the National Outcomes Scales (HoNOS) family of measures, are used in a variety of benchmarking activities. Use in exploring similarities and differences in consumers between services and the outcomes of care are illustrated. This requires the rigour of science in data management and interpretation, supplemented by the art that comes from clinical experience, a desire to reflect on clinical practice and the flexibility to use incomplete data to explore clinical practice. Routine outcome measurement data can be used in a variety of ways to support mental health benchmarking. With the increasing sophistication of information development in mental health, the opportunity to become involved in benchmarking will continue to increase. The techniques used during benchmarking and the insights gathered may prove useful to support reflection on practice by psychiatrists and other senior mental health clinicians.

  2. Prosthetists' perceptions and use of outcome measures in clinical practice: Long-term effects of focused continuing education.

    Science.gov (United States)

    Hafner, Brian J; Spaulding, Susan E; Salem, Rana; Morgan, Sara J; Gaunaurd, Ignacio; Gailey, Robert

    2017-06-01

    Continuing education is intended to facilitate clinicians' skills and knowledge in areas of practice, such as administration and interpretation of outcome measures. To evaluate the long-term effect of continuing education on prosthetists' confidence in administering outcome measures and their perceptions of outcomes measurement in clinical practice. Pretest-posttest survey methods. A total of 66 prosthetists were surveyed before, immediately after, and 2 years after outcomes measurement education and training. Prosthetists were grouped as routine or non-routine outcome measures users, based on experience reported prior to training. On average, prosthetists were just as confident administering measures 1-2 years after continuing education as they were immediately after continuing education. In all, 20% of prosthetists, initially classified as non-routine users, were subsequently classified as routine users at follow-up. Routine and non-routine users' opinions differed on whether outcome measures contributed to efficient patient evaluations (79.3% and 32.4%, respectively). Both routine and non-routine users reported challenges integrating outcome measures into normal clinical routines (20.7% and 45.9%, respectively). Continuing education had a long-term impact on prosthetists' confidence in administering outcome measures and may influence their clinical practices. However, remaining barriers to using standardized measures need to be addressed to keep practitioners current with evolving practice expectations. Clinical relevance Continuing education (CE) had a significant long-term impact on prosthetists' confidence in administering outcome measures and influenced their clinical practices. In all, approximately 20% of prosthetists, who previously were non-routine outcome measure users, became routine users after CE. There remains a need to develop strategies to integrate outcome measurement into routine clinical practice.

  3. Dignity Impact as a Primary Outcome Measure for Dignity Therapy.

    Science.gov (United States)

    Scarton, Lisa; Oh, Sungho; Sylvera, Ashley; Lamonge, Ralph; Yao, Yingwei; Chochinov, Harvey; Fitchett, George; Handzo, George; Emanuel, Linda; Wilkie, Diana

    2018-01-01

    Feasibility of dignity therapy (DT) is well established in palliative care. Evidence of its efficacy, however, has been inconsistent and may stem from DT's primary effects differing from the outcomes measured in previous studies. We proposed that DT effects were in the spiritual domain and created a new outcome measure, Dignity Impact Scale (DIS), from items previously used in a large randomized controlled trial (RCT). The purpose of this secondary analysis study was to examine properties of a new measure of dignity impact. Using the DIS, we conducted reanalysis of posttest data from a large 3-arm, multi-site RCT study. Participants were receiving hospice/palliative care (n = 326, 50.6% female, mean age = 65.1 years, 89.3% white, all with a terminal illness with 6 months or less life expectancy). They had been randomized to standard palliative care (n = 111), client-centered care (n = 107), or DT (n = 108). The 7-item DIS was derived from selected items in a posttest DT Patient Feedback Questionnaire. The DIS had strong internal consistency (α = 0.85). The DT group mean DIS score (21.4 ± 5.0) was significantly higher than the usual care group mean score (17.7 ± 5.5; t = 5.2, df = 216, P death, and life completion tasks. We propose that the DIS be used as the primary outcome measure in evaluating the effects of DT.

  4. Systematic review of tools to measure outcomes for young children with autism spectrum disorder.

    Science.gov (United States)

    McConachie, Helen; Parr, Jeremy R; Glod, Magdalena; Hanratty, Jennifer; Livingstone, Nuala; Oono, Inalegwu P; Robalino, Shannon; Baird, Gillian; Beresford, Bryony; Charman, Tony; Garland, Deborah; Green, Jonathan; Gringras, Paul; Jones, Glenys; Law, James; Le Couteur, Ann S; Macdonald, Geraldine; McColl, Elaine M; Morris, Christopher; Rodgers, Jacqueline; Simonoff, Emily; Terwee, Caroline B; Williams, Katrina

    2015-06-01

    The needs of children with autism spectrum disorder (ASD) are complex and this is reflected in the number and diversity of outcomes assessed and measurement tools used to collect evidence about children's progress. Relevant outcomes include improvement in core ASD impairments, such as communication, social awareness, sensory sensitivities and repetitiveness; skills such as social functioning and play; participation outcomes such as social inclusion; and parent and family impact. To examine the measurement properties of tools used to measure progress and outcomes in children with ASD up to the age of 6 years. To identify outcome areas regarded as important by people with ASD and parents. The MeASURe (Measurement in Autism Spectrum disorder Under Review) research collaboration included ASD experts and review methodologists. We undertook systematic review of tools used in ASD early intervention and observational studies from 1992 to 2013; systematic review, using the COSMIN checklist (Consensus-based Standards for the selection of health Measurement Instruments) of papers addressing the measurement properties of identified tools in children with ASD; and synthesis of evidence and gaps. The review design and process was informed throughout by consultation with stakeholders including parents, young people with ASD, clinicians and researchers. The conceptual framework developed for the review was drawn from the International Classification of Functioning, Disability and Health, including the domains 'Impairments', 'Activity Level Indicators', 'Participation', and 'Family Measures'. In review 1, 10,154 papers were sifted - 3091 by full text - and data extracted from 184; in total, 131 tools were identified, excluding observational coding, study-specific measures and those not in English. In review 2, 2665 papers were sifted and data concerning measurement properties of 57 (43%) tools were extracted from 128 papers. Evidence for the measurement properties of the reviewed

  5. Measure of functional independence dominates discharge outcome prediction after inpatient rehabilitation for stroke.

    Science.gov (United States)

    Brown, Allen W; Therneau, Terry M; Schultz, Billie A; Niewczyk, Paulette M; Granger, Carl V

    2015-04-01

    Identifying clinical data acquired at inpatient rehabilitation admission for stroke that accurately predict key outcomes at discharge could inform the development of customized plans of care to achieve favorable outcomes. The purpose of this analysis was to use a large comprehensive national data set to consider a wide range of clinical elements known at admission to identify those that predict key outcomes at rehabilitation discharge. Sample data were obtained from the Uniform Data System for Medical Rehabilitation data set with the diagnosis of stroke for the years 2005 through 2007. This data set includes demographic, administrative, and medical variables collected at admission and discharge and uses the FIM (functional independence measure) instrument to assess functional independence. Primary outcomes of interest were functional independence measure gain, length of stay, and discharge to home. The sample included 148,367 people (75% white; mean age, 70.6±13.1 years; 97% with ischemic stroke) admitted to inpatient rehabilitation a mean of 8.2±12 days after symptom onset. The total functional independence measure score, the functional independence measure motor subscore, and the case-mix group were equally the strongest predictors for any of the primary outcomes. The most clinically relevant 3-variable model used the functional independence measure motor subscore, age, and walking distance at admission (r(2)=0.107). No important additional effect for any other variable was detected when added to this model. This analysis shows that a measure of functional independence in motor performance and age at rehabilitation hospital admission for stroke are predominant predictors of outcome at discharge in a uniquely large US national data set. © 2015 American Heart Association, Inc.

  6. Measuring what matters to rare disease patients - reflections on the work by the IRDiRC taskforce on patient-centered outcome measures.

    Science.gov (United States)

    Morel, Thomas; Cano, Stefan J

    2017-11-02

    Our ability to evaluate outcomes which genuinely reflect patients' unmet needs, hopes and concerns is of pivotal importance. However, much current clinical research and practice falls short of this objective by selecting outcome measures which do not capture patient value to the fullest. In this Opinion, we discuss Patient-Centered Outcomes Measures (PCOMs), which have the potential to systematically incorporate patient perspectives to measure those outcomes that matter most to patients. We argue for greater multi-stakeholder collaboration to develop PCOMs, with rare disease patients and families at the center. Beyond advancing the science of patient input, PCOMs are powerful tools to translate care or observed treatment benefit into an 'interpretable' measure of patient benefit, and thereby help demonstrate clinical effectiveness. We propose mixed methods psychometric research as the best route to deliver fit-for-purpose PCOMs in rare diseases, as this methodology brings together qualitative and quantitative research methods in tandem with the explicit aim to efficiently utilise data from small samples. And, whether one opts to develop a brand-new PCOM or to select or adapt an existing outcome measure for use in a rare disease, the anchors remain the same: patients, their daily experience of the rare disease, their preferences, core concepts and values. Ultimately, existing value frameworks, registries, and outcomes-based contracts largely fall short of consistently measuring the full range of outcomes that matter to patients. We argue that greater use of PCOMs in rare diseases would enable a fast track to Patient-Centered Care.

  7. A hierarchy of patient-reported outcome measures for meta-analysis of knee osteoarthritis trials

    DEFF Research Database (Denmark)

    Juhl, Carsten Bogh; Lund, Hans; Guyatt, GH

    2010-01-01

    Title A hierarchy of patient-reported outcome measures for meta-analysis of knee osteoarthritis trials: empirical evidence from a survey of high impact journals Objective To develop a prioritized list for extracting patient-reported outcomes (PROs) measuring pain and disability for meta-analyses ......Title A hierarchy of patient-reported outcome measures for meta-analysis of knee osteoarthritis trials: empirical evidence from a survey of high impact journals Objective To develop a prioritized list for extracting patient-reported outcomes (PROs) measuring pain and disability for meta...... composite disability scores. Conclusions As choosing the most favorable PROs from individual trials can overestimate the effect compared to a systematic approach, using a prioritized list as presented in this study is recommended to reduce reviewer's likelihood of biased selection of PROs in meta-analyses....

  8. Functional outcome measures in a surgical model of hip osteoarthritis in dogs.

    Science.gov (United States)

    Little, Dianne; Johnson, Stephen; Hash, Jonathan; Olson, Steven A; Estes, Bradley T; Moutos, Franklin T; Lascelles, B Duncan X; Guilak, Farshid

    2016-12-01

    The hip is one of the most common sites of osteoarthritis in the body, second only to the knee in prevalence. However, current animal models of hip osteoarthritis have not been assessed using many of the functional outcome measures used in orthopaedics, a characteristic that could increase their utility in the evaluation of therapeutic interventions. The canine hip shares similarities with the human hip, and functional outcome measures are well documented in veterinary medicine, providing a baseline for pre-clinical evaluation of therapeutic strategies for the treatment of hip osteoarthritis. The purpose of this study was to evaluate a surgical model of hip osteoarthritis in a large laboratory animal model and to evaluate functional and end-point outcome measures. Seven dogs were subjected to partial surgical debridement of cartilage from one femoral head. Pre- and postoperative pain and functional scores, gait analysis, radiographs, accelerometry, goniometry and limb circumference were evaluated through a 20-week recovery period, followed by histological evaluation of cartilage and synovium. Animals developed histological and radiographic evidence of osteoarthritis, which was correlated with measurable functional impairment. For example, Mankin scores in operated limbs were positively correlated to radiographic scores but negatively correlated to range of motion, limb circumference and 20-week peak vertical force. This study demonstrates that multiple relevant functional outcome measures can be used successfully in a large laboratory animal model of hip osteoarthritis. These measures could be used to evaluate relative efficacy of therapeutic interventions relevant to human clinical care.

  9. An assessment of prospective memory retrieval in women with chronic fatigue syndrome using a virtual-reality environment: an initial study.

    Science.gov (United States)

    Attree, Elizabeth A; Dancey, Christine P; Pope, Alison L

    2009-08-01

    People with chronic fatigue syndrome (CFS) have increased rates of depression, anxiety, and illness intrusiveness; they may also suffer from cognitive problems such as retrospective memory (RM) deficits and concentration difficulties that can stem from diminished information-processing capability. We predicted that this diminished capacity may also lead to deficits in other cognitive functions, such as prospective memory (ProM). Event-, time-, and activity-based ProM was assessed in 11 women with CFS and 12 healthy women using a computer-generated virtual environment (VE). RM was assessed using a free-recall test, and subjective assessment of both ProM and RM was assessed by questionnaire. Groups were equivalent in age and measures of IQ. People with CFS performed slightly worse than healthy controls on both the event- and time-based ProM measures, although these were not statistically significant. However, the CFS group performed significantly worse than the healthy controls on both the free recall-task and on subjective assessment of both RM and ProM. Women with CFS do have some subtle decrements in memory, particularly RM. However, it is possible that the decrements found in the present sample would be greater in real life. Further studies utilizing both healthy controls and illness controls are now needed to ascertain how sensitive the VE measure is and to inform the development of tasks in the VE that place progressively increasing demands on working memory capacity.

  10. Treatment of Phonological Disorder: A Feasibility Study With Focus on Outcome Measures.

    Science.gov (United States)

    Smit, Ann Bosma; Brumbaugh, Klaire Mann; Weltsch, Barbara; Hilgers, Melanie

    2018-02-20

    In a feasibility study for a randomized controlled trial of treatments for phonological disorders conducted over a period of 8 months, we examined 6 clinically relevant outcome measures. We took steps to reduce error variance and to maximize systematic variance. Six children received traditional treatment (Van Riper, 1939), and 7 received expansion points (Smit, 2000), a treatment program with both phonological and traditional elements. Outcome measures, which were applied to both word list and conversational samples, included percentage of consonants correct (PCC; Shriberg & Kwiatkowski, 1982), PCC for late and/or difficult (L/D) consonants and number of L/D consonants acquired. In repeated-measures analyses of variance, all measures showed significant differences from pretreatment to posttreatment, and the word list measures were associated with very high power values. In analyses of covariance for between-groups contrasts, the adjusted expansion points mean exceeded the adjusted traditional treatment mean for every measure; however, no differences reached significance. For the L/D PCC (conversation) measure, the contrast between groups was associated with a large effect size. We recommend that practitioners use outcome measures related to a word list. We recommend that researchers consider using L/D PCC on the basis of conversational samples to detect differences among treatment groups. https://doi.org/10.23641/asha.5872677.

  11. Assessment of sexual difficulties associated with multi-modal treatment for cervical or endometrial cancer: A systematic review of measurement instruments.

    Science.gov (United States)

    White, Isabella D; Sangha, Amrit; Lucas, Grace; Wiseman, Theresa

    2016-12-01

    Practitioners and researchers require an outcome measure that accurately identifies the range of common treatment-induced changes in sexual function and well-being experienced by women after cervical or endometrial cancer. This systematic review critically appraised the measurement properties and clinical utility of instruments validated for the measurement of female sexual dysfunction (FSD) in this clinical population. A bibliographic database search for questionnaire development or validation papers was completed and methodological quality and measurement properties of selected studies rated using the Consensus-based Standards for the selection of health Measurement Instrument (COSMIN) checklist. 738 articles were screened, 13 articles retrieved for full text assessment and 7 studies excluded, resulting in evaluation of 6 papers; 2 QoL and 4 female sexual morbidity measures. Five of the six instruments omitted one or more dimension of female sexual function and only one instrument explicitly measured distress associated with sexual changes as per DSM V (APA 2013) diagnostic criteria. None of the papers reported measurement error, responsiveness data was available for only two instruments, three papers failed to report on criterion validity, and test-retest reliability reporting was inconsistent. Heterosexual penile-vaginal intercourse remains the dominant sexual activity focus for sexual morbidity PROMS terminology and instruments lack explicit reference to solo or non-coital sexual expression or validation in a non-heterosexual sample. Four out of six instruments included mediating treatment or illness items such as vaginal changes, menopause or altered body image. Findings suggest that the Female Sexual Function Index (FSFI) remains the most robust sexual morbidity outcome measure, for research or clinical use, in sexually active women treated for cervical or endometrial cancer. Development of an instrument that measures sexual dysfunction in women who are

  12. Proposed outcome measures for prospective clinical trials in juvenile idiopathic arthritis-associated uveitis

    DEFF Research Database (Denmark)

    Heiligenhaus, Arnd; Foeldvari, Ivan; Edelsten, Clive

    2012-01-01

    To develop a set of core outcome measures for use in randomized controlled trials (RCTs) and longitudinal observational studies in juvenile idiopathic arthritis (JIA)-associated uveitis.......To develop a set of core outcome measures for use in randomized controlled trials (RCTs) and longitudinal observational studies in juvenile idiopathic arthritis (JIA)-associated uveitis....

  13. Toward Ensuring Health Equity

    DEFF Research Database (Denmark)

    Petkovic, Jennifer; Epstein, Jonathan; Buchbinder, Rachelle

    2015-01-01

    , the Evaluative Linguistic Framework for Questionnaires, developed to assess text quality of questionnaires. We also considered a study assessing cross-cultural adaptation with/without back-translation and/or expert committee. The results of this preconference work were presented to the equity working group......OBJECTIVE: The goal of the Outcome Measures in Rheumatology (OMERACT) 12 (2014) equity working group was to determine whether and how comprehensibility of patient-reported outcome measures (PROM) should be assessed, to ensure suitability for people with low literacy and differing cultures. METHODS......: The English, Dutch, French, and Turkish Health Assessment Questionnaires and English and French Osteoarthritis Knee and Hip Quality of Life questionnaires were evaluated by applying 3 readability formulas: Flesch Reading Ease, Flesch-Kincaid grade level, and Simple Measure of Gobbledygook; and a new tool...

  14. Retail price as an outcome measure for the effectiveness of drug law enforcement.

    Science.gov (United States)

    Bright, David A; Ritter, Alison

    2010-09-01

    One outcome measure of law enforcement effectiveness is the reduction in drug consumption which occurs as a result of law enforcement interventions. A theoretical relationship between drug consumption and retail price has promoted the use of retail price as a surrogate measure for consumption. In the current article, retail price is examined as a potential outcome measure for the effectiveness of law enforcement. The predictions regarding the relationship between law enforcement intensity and price are only partially supported by research. Explanations for the disconnect between the drug law enforcement activity and retail price include: rapid adaptation by market players, enforcement swamping, assumptions of rational actors, short-run versus long-run effects, structure of the illicit market, simultaneous changes that affect price in perverse ways, the role of violence in markets, and data limitations. Researchers who use retail price as an outcome measure need to take into account the complex relationship between drug law enforcement interventions and the retail price of illicit drugs. Viable outcome measures which can be used as complements to retail price are worth investigation. Copyright 2009 Elsevier B.V. All rights reserved.

  15. A Systematic Review of Clinical Functional Outcomes After Medial Stabilized Versus Non-Medial Stabilized Total Knee Joint Replacement

    Directory of Open Access Journals (Sweden)

    Tony Young

    2018-04-01

    Full Text Available Background Medial stabilized total knee joint replacement (TKJR construct is designed to closely replicate the kinematics of the knee. Little is known regarding comparison of clinical functional outcomes of patients utilising validated patient reported outcome measures (PROM after medial stabilized TKJR and other construct designs.PurposeTo perform a systematic review of the available literature related to the assessment of clinical functional outcomes following a TKJR employing a medial stabilized construct design.MethodsThe review was performed with a Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA algorithm. The literature search was performed using variouscombinations of keywords. The statistical analysis was completed using Review Manager (RevMan, Version 5.3.ResultsIn the nineteen unique studies identified, there were 2,448 medial stabilized TKJRs implanted in 2,195 participants, there were 1,777 TKJRs with non-medial stabilized design constructs implanted in 1,734 subjects. The final mean Knee Society Score (KSS value in the medial stabilized group was 89.92 compared to 90.76 in the non-medial stabilized group, with the final KSS mean value difference between the two groups was statistically significant and favored the non-medial stabilized group (SMD 0.21; 95% CI: 0.01 to 0.41; p = 004. The mean difference in the final WOMAC values between the two groups was also statistically significant and favored the medial stabilized group (SMD: −0.27; 95% CI: −0.47 to −0.07; p = 0.009. Moderate to high values (I2 of heterogeneity were observed during the statistical comparison of these functional outcomes.ConclusionBased on the small number of studies with appropriate statistical analysis, we are unable to reach a clear conclusion in the clinical performance of medial stabilized knee replacement construct.Level of EvidenceLevel II

  16. Measuring quality of life in cleft lip and palate patients: currently available patient-reported outcomes measures.

    Science.gov (United States)

    Eckstein, Donna A; Wu, Rebecca L; Akinbiyi, Takintope; Silver, Lester; Taub, Peter J

    2011-11-01

    Patient-reported outcomes in cleft lip and palate treatment are critical for patient care. Traditional surgical outcomes focused on objective measures, such as photographs, anatomic measurements, morbidity, and mortality. Although these remain important, they leave many questions unanswered. Surveys that include aesthetics, speech, functionality, self-image, and quality of life provide more thorough outcomes assessment. It is vital that reliable, valid, and comprehensive questionnaires are available to craniofacial surgeons. The authors performed a literature review to identify questionnaires validated in cleft lip and palate patients. Qualifying instruments were assessed for adherence to guidelines for development and validation by the scientific advisory committee and for content. The authors identified 44 measures used in cleft lip and palate studies. After 15 ad hoc questionnaires, eight generic instruments, 11 psychiatric instruments, and one non-English language questionnaire were excluded, nine measures remained. Of these, four were never validated in the cleft population. Analysis revealed one craniofacial-specific measure (Youth Quality of Life-Facial Differences), two voice-related measures (Patient Voice-Related Quality of Life and Cleft Audit Protocol for Speech-Augmented), and two oral health-related measures (Child Oral Health Impact Profile and Child Oral Health Quality of Life). The Youth Quality of Life-Facial Differences, Child Oral Health Impact Profile, and Child Oral Health Quality of Life questionnaires were sufficiently validated. None was created specifically for clefts, resulting in content limitations. There is a lack of comprehensive, valid, and reliable questionnaires for cleft lip and palate surgery. For thorough assessment of satisfaction, further research to develop and validate cleft lip and palate surgery-specific instruments is needed.

  17. Outcome measures and definition of cure in female stress urinary incontinence surgery: a survey of recent publications.

    Science.gov (United States)

    Castillo, Peter A; Espaillat-Rijo, Luis M; Davila, G Willy

    2010-03-01

    Much variability exists in outcome measures used to report success of SUI surgery. We set out to evaluate outcome measures and definitions of cure in SUI surgery studies. Outcome measures, success rates, and definition of cure were analyzed from published series and compared to recommendations by leading authorities. Ninety-one publications were analyzed. Thirty (33%) utilized solely subjective measures, four (4%) utilized only objective measures, and 57 (63%) included both. Sixty-one (67%) used symptom questionnaires, 56 (60%) QOL questionnaires, and six (7%) visual analog scale. Twelve (13%) used voiding diaries and 52 (56%) used self-reporting as an outcome measure. Objective measures: 52 (57%) cough stress test, 37 (41%) urodynamic evaluation, 28 (31%) pad testing and a combination in 33 (36%). Few studies adhered to one set of outcome recommendations. Outcome measures used to evaluate success of anti-incontinence procedures lack consensus and comparability.

  18. Developing a General Outcome Measure Off Growth in Social Skills for Infants and Toddlers

    Science.gov (United States)

    Carta, Judith; Greenwood, Charles; Luze, Gayle; Cline, Gabriel; Kuntz, Susan

    2004-01-01

    Proficiency in social interaction with adults and peers is an important outcome in early childhood. The development of an experimental measure for assessing growth in social skills in children birth to 3 years is described. Based on the general outcome measurement (GOM) approach (e.g., Deno, 1997), the measure is intended for use by early…

  19. Developing a General Outcome Measure of Growth in Social Skills for Infants and Toddlers

    Science.gov (United States)

    Carta, Judith; Greenwood, Charles; Luze, Gayle; Cline, Gabriel; Kuntz, Susan

    2004-01-01

    Proficiency in social interaction with adults and peers is an important outcome in early childhood. The development of an experimental measure for assessing growth in social skills in children birth to 3 years is described. Based on the general outcome measurement (GOM) approach (e.g., Deno, 1997), the measure is intended for use by early…

  20. Development of the FOCUS (Focus on the Outcomes of Communication under Six), a Communication Outcome Measure for Preschool Children

    Science.gov (United States)

    Thomas-Stonell, Nancy L.; Oddson, Bruce; Robertson, Bernadette; Rosenbaum, Peter L.

    2010-01-01

    Aim: Our aim was to develop an outcome measure, called Focus on the Outcomes of Communication Under Six (FOCUS), that captures real-world changes in preschool children's communication. Conceptually grounded in the World Health Organization International Classification of Functioning, Disability and Health framework, the FOCUS items were derived…

  1. Using Cross-Cultural Dimensions Exercises to Improve and Measure Learning Outcomes in International Business Courses

    Science.gov (United States)

    Zainuba, Mohamed; Rahal, Ahmad

    2012-01-01

    This article proposes an approach for using cross-cultural dimensions exercises to improve and measure learning outcomes in international business courses. The following key issues are highlighted: (a) what are the targeted learning outcomes to be assessed, (b) how to measure the accomplishment of these learning outcomes, (c) the input measures…

  2. Goal setting as an outcome measure: A systematic review.

    Science.gov (United States)

    Hurn, Jane; Kneebone, Ian; Cropley, Mark

    2006-09-01

    Goal achievement has been considered to be an important measure of outcome by clinicians working with patients in physical and neurological rehabilitation settings. This systematic review was undertaken to examine the reliability, validity and sensitivity of goal setting and goal attainment scaling approaches when used with working age and older people. To review the reliability, validity and sensitivity of both goal setting and goal attainment scaling when employed as an outcome measure within a physical and neurological working age and older person rehabilitation environment, by examining the research literature covering the 36 years since goal-setting theory was proposed. Data sources included a computer-aided literature search of published studies examining the reliability, validity and sensitivity of goal setting/goal attainment scaling, with further references sourced from articles obtained through this process. There is strong evidence for the reliability, validity and sensitivity of goal attainment scaling. Empirical support was found for the validity of goal setting but research demonstrating its reliability and sensitivity is limited. Goal attainment scaling appears to be a sound measure for use in physical rehabilitation settings with working age and older people. Further work needs to be carried out with goal setting to establish its reliability and sensitivity as a measurement tool.

  3. Measure for measure. Outcome assessment of arthritis treatment in clinical practice

    OpenAIRE

    Gülfe, Anders

    2009-01-01

    Objective: To investigate (i) the performance and agreement between various activity indices and response criteria in TNF-blockade of RA; (ii) the predictive ability of different response criteria and disease activity states regarding continuation of anti-TNF treatment of RA; (iii) Euro-QoL-5-dimensions utility development during TNF blockade of RA, PsA and SpA. Also, (iv) to develop a simple, utility-based outcome measure, the number needed to treat per quality adjusted life year gained (NN...

  4. The effects of intra-articular glucocorticoids and exercise on pain and synovitis assessed on static and dynamic magnetic resonance imaging in knee osteoarthritis

    DEFF Research Database (Denmark)

    Riis, R G C; Henriksen, M; Klokker, L

    2017-01-01

    ) investigate if any of the changes in patient reported outcome measures (PROMs) were associated with changes in MRI-measures of synovitis. DESIGN: We performed a randomized, double-blinded, placebo-controlled clinical trial evaluating the effects of intra-articular corticosteroid vs placebo injections given......-articular corticosteroids over intra-articular saline when combined with an exercise program for reduction of synovitis in KOA. The improvement in pain and function following the intervention with intra-articular corticosteroids/saline and exercise could not be explained by a decrease in synovitis on MRI indicating other...... pain causing/relieving mechanisms in KOA....

  5. The uses of outcome measures within multidisciplinary early childhood intervention services: a systematic review.

    Science.gov (United States)

    Calder, Samuel; Ward, Roslyn; Jones, Megan; Johnston, Jenelle; Claessen, Mary

    2017-07-18

    Purpose of the article: To review the use of outcome measures, across the domains of activity, participation, and environment, within multidisciplinary early childhood intervention services. A systematic literature search was undertaken that included four electronic databases: Medline, CINAHL, EMBASE, and the Cochrane Library and Cochrane Database of Systematic Review. Inclusion criteria were age 0-24 months, having or at risk of a developmental disability, in receipt of multidisciplinary early childhood intervention services, and included outcome measures across all domains of the International Classification of Functioning-Child & Youth (ICF-CY). Only peer-reviewed journal articles were considered. Eligible studies were coded using the Oxford Levels of Evidence. Methodological quality was assessed using the Physiotherapy Evidence Database (PEDro) Scale for randomised controlled trials and the QualSyst for non-randomised control trials. Of the total of 5764 records identified, 10 were considered to meet inclusion criteria. Fourteen outcome measures were identified, addressing the domains of activity, participation, and environment. Of these, eight have been recommended in the early intervention literature. While the methodological quality of the 10 studies varied, these papers make a contribution to the body of research that acknowledges the role of routine and enriched environments. Implications for Rehabilitation Core practice elements of multidisciplinary early childhood intervention services indicate it is necessary to select outcome measures framed within the International Classification of Functioning-Child & Youth to inform clinical decision-making for measuring intervention effectiveness across the domains of activity, participation and environment. Of the identified measures, three (Canadian Occupational Performance Measure, Pediatric Evaluation of Disability Inventory, and Goal Attainment Scaling) are well-established and identified in the literature as

  6. Towards global consensus on outcome measures for atopic eczema research: results of the HOME II meeting.

    Science.gov (United States)

    Schmitt, Jochen; Spuls, Phyllis; Boers, Maarten; Thomas, Kim; Chalmers, Joanne; Roekevisch, Evelien; Schram, Mandy; Allsopp, Richard; Aoki, Valeria; Apfelbacher, Christian; Bruijnzeel-Koomen, Carla; Bruin-Weller, Marjolein; Charman, Carolyn; Cohen, Arnon; Dohil, Magdalene; Flohr, Carsten; Furue, Masutaka; Gieler, Uwe; Hooft, Lotty; Humphreys, Rosemary; Ishii, Henrique Akira; Katayama, Ichiro; Kouwenhoven, Willem; Langan, Sinéad; Lewis-Jones, Sue; Merhand, Stephanie; Murota, Hiroyuki; Murrell, Dedee F; Nankervis, Helen; Ohya, Yukihiro; Oranje, Arnold; Otsuka, Hiromi; Paul, Carle; Rosenbluth, Yael; Saeki, Hidehisa; Schuttelaar, Marie-Louise; Stalder, Jean-Francois; Svensson, Ake; Takaoka, Roberto; Wahlgren, Carl-Fredrik; Weidinger, Stephan; Wollenberg, Andreas; Williams, Hywel

    2012-09-01

    The use of nonstandardized and inadequately validated outcome measures in atopic eczema trials is a major obstacle to practising evidence-based dermatology. The Harmonising Outcome Measures for Eczema (HOME) initiative is an international multiprofessional group dedicated to atopic eczema outcomes research. In June 2011, the HOME initiative conducted a consensus study involving 43 individuals from 10 countries, representing different stakeholders (patients, clinicians, methodologists, pharmaceutical industry) to determine core outcome domains for atopic eczema trials, to define quality criteria for atopic eczema outcome measures and to prioritize topics for atopic eczema outcomes research. Delegates were given evidence-based information, followed by structured group discussion and anonymous consensus voting. Consensus was achieved to include clinical signs, symptoms, long-term control of flares and quality of life into the core set of outcome domains for atopic eczema trials. The HOME initiative strongly recommends including and reporting these core outcome domains as primary or secondary endpoints in all future atopic eczema trials. Measures of these core outcome domains need to be valid, sensitive to change and feasible. Prioritized topics of the HOME initiative are the identification/development of the most appropriate instruments for the four core outcome domains. HOME is open to anyone with an interest in atopic eczema outcomes research. © 2012 John Wiley & Sons A/S.

  7. Heterogeneity of wound outcome measures in RCTs of treatments for VLUs: a systematic review.

    Science.gov (United States)

    Gethin, G; Killeen, F; Devane, D

    2015-05-01

    Venous leg ulcers (VLUs) affect up to 4% of the population aged over 65 years. Outcomes of randomised controlled trials (RCTs) in VLUs are important to guide clinical and resource decision making. Our objective was to identify what endpoints and wound bed outcomes were assessed in RCTs in VLUs; how these were assessed and what reference was made to validity and reliability of methods used. A systematic review of all full text RCTs, published in English, from 1998-2013. Our criteria were met by 102 studies. There were 78 different endpoints recorded, the majority (n=34) related to healing and were evaluated at 12 different times points. Size was the most frequently reported outcome measure (n=99), with photographs, tissue type, exudate, odour and pain also recorded. There was poor reporting of methods used to assess outcomes. Visual analogue scales predominated as a method of assessment, but 95% of studies made no reference to the validity or reliability of assessment methods. Future research in VLUs requires standards for measuring outcomes with acceptable inter-rater reliability and validated measures of patient-reported outcomes.

  8. Functional outcome measures in a surgical model of hip osteoarthritis in dogs

    OpenAIRE

    Little, Dianne; Johnson, Stephen; Hash, Jonathan; Olson, Steven A.; Estes, Bradley T.; Moutos, Franklin T.; Lascelles, B. Duncan X.; Guilak, Farshid

    2016-01-01

    Background The hip is one of the most common sites of osteoarthritis in the body, second only to the knee in prevalence. However, current animal models of hip osteoarthritis have not been assessed using many of the functional outcome measures used in orthopaedics, a characteristic that could increase their utility in the evaluation of therapeutic interventions. The canine hip shares similarities with the human hip, and functional outcome measures are well documented in veterinary medicine, pr...

  9. Characteristics of children with cerebral palsy in the ORACLE children study.

    Science.gov (United States)

    Marlow, Neil; Pike, Katie; Bower, Eva; Brocklehurst, Peter; Jones, David; Kenyon, Sara; Kurinczuk, Jennifer J; Taylor, David; Salt, Alison

    2012-07-01

    We have identified an excess of children with cerebral palsy (CP) born to women who received antibiotic treatment for spontaneous preterm labour (SPL). This nested study investigated the profile of impairment among children with CP in the ORACLE Children Study (OCS), and contrasted outcomes with those in 4Child, a population CP registry. The study group comprised 167 children aged from 7 to 10 years (100 males, 67 females) with CP from the OCS, who were subdivided into a preterm rupture of membranes (PROM) group (87 children) and an SPL group (80 children). The OCS sought follow-up information regarding the health and behaviour of surviving children at 7 years of age in the UK using a parent-report postal questionnaire. Families provided further information to define wider aspects of function and were offered a physiotherapy assessment. The prevalence of CP was higher among children in the OCS than among those in 4Child (standardized morbidity ratios: SPL group, 3.12 [95% confidence interval {CI} 2.47-3.87); PROM group: 1.56 (CI 1.24-1.92)]. The proportion of children with CP born after 32 weeks of gestation was higher in in the SPL group (73%) than in the PROM group (30%); the prevalence of CP was higher in the SPL group than in the PROM group or 4Child. Children with CP in the OCS tended to have similar distributions of neuroimpairment as children in 4Child, but motor impairment and associated vision and hearing problems were found to be less severe. The pattern of CP in both the PROM and the SPL groups was similar, but functional outcomes were milder, compared with children with CP in the general population. However, in these groups the risk of CP was increased independently of gestational age. This is consistent with findings that ongoing inflammatory damage can cause CP. © The Authors. Developmental Medicine & Child Neurology © 2012 Mac Keith Press.

  10. Vertical ground reaction forces in patients after calcaneal trauma surgery.

    Science.gov (United States)

    van Hoeve, S; Verbruggen, J; Willems, P; Meijer, K; Poeze, M

    2017-10-01

    Vertical ground reaction forces (VGRFs) are altered in patients after foot trauma. It is not known if this correlates with ankle kinematics. The aim of this study was to analyze VGRFs in patients after calcaneal trauma and correlate them to patient-reported outcome measures (PROMs), radiographic findings and kinematic analysis, using a multi-segment foot model. In addition, we determined the predictive value of VGRFs to identify patients with altered foot kinematics. Thirteen patients (13 feet) with displaced intra-articular calcaneal fractures, were included an average of two years after trauma surgery. PROMs, radiographic findings on postoperative computed tomography scans, gait analysis using the Oxford foot model and VGRFs were analysed during gait. Results were compared with those of 11 healthy subjects (20 feet). Speed was equal in both groups, with healthy subjects walking at self-selected slow speed (0.94±0.18m/s) and patients after surgery walking at self-selected normal speed (0.94±0.29m/s). ROC curves were used to determine the predictive value. Patients after calcaneal surgery showed a lower minimum force during midstance (p=0.004) and a lower maximum force during toe-off (p=0.011). This parameter correlated significantly with the range of motion in the sagittal plane during the push-off phase (r 0.523, p=0.002), as well as with PROMs and with postoperative residual step-off (r 0.423, p=0.016). Combining these two parameters yielded a cut-off value of 193% (ppush-off correlated significantly with PROMs, range of motion in the sagittal plane during push-off and radiographic postoperative residual step-off in the posterior facet of the calcaneal bone. VGRFs are a valuable screening tool for identifying patients with altered gait patterns. Copyright © 2017 Elsevier B.V. All rights reserved.

  11. [Clinical evaluation of flomoxef in the treatment of chorioamnionitis and changes in the fetal fibronectin level in vaginal secretion].

    Science.gov (United States)

    Chimura, T; Hirayama, T; Oda, T; Saitou, N; Morisaki, N

    1993-02-01

    Flomoxef (FMOX) was administered as an initial treatment for chorioamnionitis complicating possible spontaneous abortion or premature delivery and preterm PROM (premature rupture of the membranes), and the clinical effectiveness of the drug, and the usefulness of fetal fibronectin (FFN) as a diagnostic marker of premature delivery were evaluated. 1. Clinical effects of drip infusion of FMOX (2-4 g/day) with and without tocolysis for the treatment of chorioamnionitis were evaluated in 43 patients with possible spontaneous abortion or premature delivery and those with preterm PROM (n = 43). Changes in the FFN level in the vaginal secretion were also studied in 11 patients. 2. It was possible to prevent premature delivery in 7 (26.9%) of 26 patients, and the latent period of preterm PROM was longer than 8 days in 6 (46.2%) of 13 patients. 3. The FFN level decreased slightly in patients for whom FMOX was effective, and the outcome was satisfactory in those whose FFN levels were less than 200 ng/ml. However, the outcome was poor in those whose FFN levels were higher than 1,000 ng/ml. These findings suggest that changes in the FFN level in the vaginal secretion reflect the clinical course of chorioamnionitis as do changes in CRP.

  12. Psychometric properties of the Spanish version of the Clinical Outcomes in Routine Evaluation – Outcome Measure

    Directory of Open Access Journals (Sweden)

    Trujillo A

    2016-06-01

    Full Text Available Adriana Trujillo,1,2 Guillem Feixas,1,2 Arturo Bados,1 Eugeni García-Grau,1 Marta Salla,1 Joan Carles Medina,1 Adrián Montesano,1,2 José Soriano,3 Leticia Medeiros-Ferreira,4 Josep Cañete,5 Sergi Corbella,6 Antoni Grau,7 Fernando Lana,8 Chris Evans9 1Department of Personality, Assessment and Psychological Treatments, Faculty of Psychology, 2Institute for Brain, Cognition and Behaviour, University of Barcelona, 3Hospital of the Holy Cross and Saint Paul, 4Nou Barris Mental Health Center, Barcelona, 5Hospital of Mataró, Sanitary Consortium of Maresme, Mataró, 6FPCEE, Blanquerna, Universitat Ramon Llull, 7Institute of Eating Disorders, Barcelona, 8MAR Health Park, CAEMIL, Santa Coloma de Gramenet, Spain; 9East London NHS Foundation Trust, NPDDNet, London, UK Objective: The objective of this paper is to assess the reliability and validity of the Spanish translation of the Clinical Outcomes in Routine Evaluation – Outcome Measure, a 34-item self-report questionnaire that measures the client’s status in the domains of Subjective well-being, Problems/Symptoms, Life functioning, and Risk.Method: Six hundred and forty-four adult participants were included in two samples: the clinical sample (n=192 from different mental health and primary care centers; and the nonclinical sample (n=452, which included a student and a community sample.Results: The questionnaire showed good acceptability and internal consistency, appropriate test–retest reliability, and acceptable convergent validity. Strong differentiation between clinical and nonclinical samples was found. As expected, the Risk domain had different characteristics than other domains, but all findings were comparable with the UK referential data. Cutoff scores were calculated for clinical significant change assessment.Conclusion: The Spanish version of the Clinical Outcomes in Routine Evaluation – Outcome Measure showed acceptable psychometric properties, providing support for using the

  13. Psychometrics of the Personal Questionnaire: A client-generated outcome measure.

    Science.gov (United States)

    Elliott, Robert; Wagner, John; Sales, Célia M D; Rodgers, Brian; Alves, Paula; Café, Maria J

    2016-03-01

    We present a range of evidence for the reliability and validity of data generated by the Personal Questionnaire (PQ), a client-generated individualized outcome measure, using 5 data sets from 3 countries. Overall pretherapy mean internal consistency (alpha) across clients was .80, and within-client alphas averaged .77; clients typically had 1 or 2 items that did not vary with the other items. Analyses of temporal structure indicated high levels of between-clients variance (58%), moderate pretherapy test-retest correlation (r = .57), and high session-to-session Lag-1 autocorrelation (.82). Scores on the PQ provided clear evidence of convergence with a range of outcome measures (within-client r = .41). Mean pre-post effects were large (d = 1.25). The results support a revised caseness cutoff of 3.25 and a reliable change index interval of 1.67. We conclude that PQ data meet criteria for evidence-based, norm-referenced measurement of client psychological distress for supporting psychotherapy practice and research. (c) 2016 APA, all rights reserved).

  14. Comparison of reliability and responsiveness of patient-reported clinical outcome measures in knee osteoarthritis rehabilitation.

    Science.gov (United States)

    Williams, Valerie J; Piva, Sara R; Irrgang, James J; Crossley, Chad; Fitzgerald, G Kelley

    2012-08-01

    Secondary analysis, pretreatment-posttreatment observational study. To compare the reliability and responsiveness of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Knee Outcome Survey activities of daily living subscale (KOS-ADL), and the Lower Extremity Functional Scale (LEFS) in individuals with knee osteoarthritis (OA). The WOMAC is the current standard in patient-reported measures of function in patients with knee OA. The KOS-ADL and LEFS were designed for potential use in patients with knee OA. If the KOS-ADL and LEFS are to be considered viable alternatives to the WOMAC for measuring patient-reported function in individuals with knee OA, they should have measurement properties comparable to the WOMAC. It would also be important to determine whether either of these instruments may be superior to the WOMAC in terms of reliability or responsiveness in this population. Data from 168 subjects with knee OA, who participated in a rehabilitation program, were used in the analyses. Reliability and responsiveness of each outcome measure were estimated at follow-ups of 2, 6, and 12 months. Reliability was estimated by calculating the intraclass correlation coefficient (ICC2,1) for subjects who were unchanged in status from baseline at each follow-up time, based on a global rating of change score. To examine responsiveness, the standard error of the measurement, minimal detectable change, minimal clinically important difference, and the Guyatt responsiveness index were calculated for each outcome measure at each follow-up time. All 3 outcome measures demonstrated reasonable reliability and responsiveness to change. Reliability and responsiveness tended to decrease somewhat with increasing follow-up time. There were no substantial differences between outcome measures for reliability or any of the 3 measures of responsiveness at any follow-up time. The results do not indicate that one outcome measure is more reliable or responsive than

  15. Towards global consensus on outcome measures for atopic eczema research: results of the HOME II meeting

    NARCIS (Netherlands)

    Schmitt, Jochen; Spuls, Phyllis; Boers, Maarten; Thomas, Kim; Chalmers, Joanne; Roekevisch, Evelien; Schram, Mandy; Allsopp, Richard; Aoki, Valeria; Apfelbacher, Christian; Bruijnzeel-Koomen, Carla; Bruin-Weller, Marjolein; Charman, Carolyn; Cohen, Arnon; Dohil, Magdalene; Flohr, Carsten; Furue, Masutaka; Gieler, Uwe; Hooft, Lotty; Humphreys, Rosemary; Ishii, Henrique Akira; Katayama, Ichiro; Kouwenhoven, Willem; Langan, Sinéad; Lewis-Jones, Sue; Merhand, Stephanie; Murota, Hiroyuki; Murrell, Dedee F.; Nankervis, Helen; Ohya, Yukihiro; Oranje, Arnold; Otsuka, Hiromi; Paul, Carle; Rosenbluth, Yael; Saeki, Hidehisa; Schuttelaar, Marie-Louise; Stalder, Jean-Francois; Svensson, Ake; Takaoka, Roberto; Wahlgren, Carl-Fredrik; Weidinger, Stephan; Wollenberg, Andreas; Williams, Hywel

    2012-01-01

    The use of nonstandardized and inadequately validated outcome measures in atopic eczema trials is a major obstacle to practising evidence-based dermatology. The Harmonising Outcome Measures for Eczema (HOME) initiative is an international multiprofessional group dedicated to atopic eczema outcomes

  16. Towards global consensus on outcome measures for atopic eczema research : Results of the HOME II meeting

    NARCIS (Netherlands)

    Schmitt, Jochen; Spuls, Phyllis; Boers, Maarten; Thomas, Kim; Chalmers, Joanne; Roekevisch, Evelien; Schram, Mandy; Allsopp, Richard; Aoki, Valeria; Apfelbacher, Christian; Bruijnzeel-Koomen, Carla; Bruin-Weller, Marjolein; Charman, Carolyn; Cohen, Arnon; Dohil, Magdalene; Flohr, Carsten; Furue, Masutaka; Gieler, Uwe; Hooft, Lotty; Humphreys, Rosemary; Ishii, Henrique Akira; Katayama, Ichiro; Kouwenhoven, Willem; Langan, Sinéad; Lewis-Jones, Sue; Merhand, Stephanie; Murota, Hiroyuki; Murrell, Dedee F; Nankervis, Helen; Ohya, Yukihiro; Oranje, Arnold; Otsuka, Hiromi; Paul, Carle; Rosenbluth, Yael; Saeki, Hidehisa; Schuttelaar, Marie-Louise; Stalder, Jean-Francois; Svensson, Ake; Takaoka, Roberto; Wahlgren, Carl-Fredrik; Weidinger, Stephan; Wollenberg, Andreas; Williams, Hywel

    The use of nonstandardized and inadequately validated outcome measures in atopic eczema trials is a major obstacle to practising evidence-based dermatology. The Harmonising Outcome Measures for Eczema (HOME) initiative is an international multiprofessional group dedicated to atopic eczema outcomes

  17. Comparative study of outcome measures and analysis methods for traumatic brain injury trials.

    Science.gov (United States)

    Alali, Aziz S; Vavrek, Darcy; Barber, Jason; Dikmen, Sureyya; Nathens, Avery B; Temkin, Nancy R

    2015-04-15

    Batteries of functional and cognitive measures have been proposed as alternatives to the Extended Glasgow Outcome Scale (GOSE) as the primary outcome for traumatic brain injury (TBI) trials. We evaluated several approaches to analyzing GOSE and a battery of four functional and cognitive measures. Using data from a randomized trial, we created a "super" dataset of 16,550 subjects from patients with complete data (n=331) and then simulated multiple treatment effects across multiple outcome measures. Patients were sampled with replacement (bootstrapping) to generate 10,000 samples for each treatment effect (n=400 patients/group). The percentage of samples where the null hypothesis was rejected estimates the power. All analytic techniques had appropriate rates of type I error (≤5%). Accounting for baseline prognosis either by using sliding dichotomy for GOSE or using regression-based methods substantially increased the power over the corresponding analysis without accounting for prognosis. Analyzing GOSE using multivariate proportional odds regression or analyzing the four-outcome battery with regression-based adjustments had the highest power, assuming equal treatment effect across all components. Analyzing GOSE using a fixed dichotomy provided the lowest power for both unadjusted and regression-adjusted analyses. We assumed an equal treatment effect for all measures. This may not be true in an actual clinical trial. Accounting for baseline prognosis is critical to attaining high power in Phase III TBI trials. The choice of primary outcome for future trials should be guided by power, the domain of brain function that an intervention is likely to impact, and the feasibility of collecting outcome data.

  18. Positive psychology outcome measures for family caregivers of people living with dementia: a systematic review.

    Science.gov (United States)

    Stansfeld, Jacki; Stoner, Charlotte R; Wenborn, Jennifer; Vernooij-Dassen, Myrra; Moniz-Cook, Esme; Orrell, Martin

    2017-08-01

    Family caregivers of people living with dementia can have both positive and negative experiences of caregiving. Despite this, existing outcome measures predominately focus on negative aspects of caregiving such as burden and depression. This review aimed to evaluate the development and psychometric properties of existing positive psychology measures for family caregivers of people living with dementia to determine their potential utility in research and practice. A systematic review of positive psychology outcome measures for family caregivers of people with dementia was conducted. The databases searched were as follows: PsychINFO, CINAHL, MEDLINE, EMBASE, and PubMed. Scale development papers were subject to a quality assessment to appraise psychometric properties. Twelve positive outcome measures and six validation papers of these scales were identified. The emerging constructs of self-efficacy, spirituality, resilience, rewards, gain, and meaning are in line with positive psychology theory. There are some robust positive measures in existence for family caregivers of people living with dementia. However, lack of reporting of the psychometric properties hindered the quality assessment of some outcome measures identified in this review. Future research should aim to include positive outcome measures in interventional research to facilitate a greater understanding of the positive aspects of caregiving and how these contribute to well-being.

  19. The quality of systematic reviews of health-related outcome measurement instruments.

    Science.gov (United States)

    Terwee, C B; Prinsen, C A C; Ricci Garotti, M G; Suman, A; de Vet, H C W; Mokkink, L B

    2016-04-01

    Systematic reviews of outcome measurement instruments are important tools for the selection of instruments for research and clinical practice. Our aim was to assess the quality of systematic reviews of health-related outcome measurement instruments and to determine whether the quality has improved since our previous study in 2007. A systematic literature search was performed in MEDLINE and EMBASE between July 1, 2013, and June 19, 2014. The quality of the reviews was rated using a study-specific checklist. A total of 102 reviews were included. In many reviews the search strategy was considered not comprehensive; in only 59 % of the reviews a search was performed in EMBASE and in about half of the reviews there was doubt about the comprehensiveness of the search terms used for type of measurement instruments and measurement properties. In 41 % of the reviews, compared to 30 % in our previous study, the methodological quality of the included studies was assessed. In 58 %, compared to 55 %, the quality of the included instruments was assessed. In 42 %, compared to 7 %, a data synthesis was performed in which the results from multiple studies on the same instrument were somehow combined. Despite a clear improvement in the quality of systematic reviews of outcome measurement instruments in comparison with our previous study in 2007, there is still room for improvement with regard to the search strategy, and especially the quality assessment of the included studies and the included instruments, and the data synthesis.

  20. Psychometric properties of carer-reported outcome measures in palliative care: A systematic review

    Science.gov (United States)

    Michels, Charlotte TJ; Boulton, Mary; Adams, Astrid; Wee, Bee; Peters, Michele

    2016-01-01

    Background: Informal carers face many challenges in caring for patients with palliative care needs. Selecting suitable valid and reliable outcome measures to determine the impact of caring and carers’ outcomes is a common problem. Aim: To identify outcome measures used for informal carers looking after patients with palliative care needs, and to evaluate the measures’ psychometric properties. Design: A systematic review was conducted. The studies identified were evaluated by independent reviewers (C.T.J.M., M.B., M.P.). Data regarding study characteristics and psychometric properties of the measures were extracted and evaluated. Good psychometric properties indicate a high-quality measure. Data sources: The search was conducted, unrestricted to publication year, in the following electronic databases: Applied Social Sciences Index and Abstracts, Cumulative Index to Nursing and Allied Health Literature, The Cochrane Library, EMBASE, PubMed, PsycINFO, Social Sciences Citation Index and Sociological Abstracts. Results: Our systematic search revealed 4505 potential relevant studies, of which 112 studies met the inclusion criteria using 38 carer measures for informal carers of patients with palliative care needs. Psychometric properties were reported in only 46% (n = 52) of the studies, in relation to 24 measures. Where psychometric data were reported, the focus was mainly on internal consistency (n = 45, 87%), construct validity (n = 27, 52%) and/or reliability (n = 14, 27%). Of these, 24 measures, only four (17%) had been formally validated in informal carers in palliative care. Conclusion: A broad range of outcome measures have been used for informal carers of patients with palliative care needs. Little formal psychometric testing has been undertaken. Furthermore, development and refinement of measures in this field is required. PMID:26407683

  1. Measuring mental health and wellbeing outcomes for children and adolescents to inform practice and policy: a review of child self-report measures.

    Science.gov (United States)

    Deighton, Jessica; Croudace, Tim; Fonagy, Peter; Brown, Jeb; Patalay, Praveetha; Wolpert, Miranda

    2014-01-01

    There is a growing appetite for mental health and wellbeing outcome measures that can inform clinical practice at individual and service levels, including use for local and national benchmarking. Despite a varied literature on child mental health and wellbeing outcome measures that focus on psychometric properties alone, no reviews exist that appraise the availability of psychometric evidence and suitability for use in routine practice in child and adolescent mental health services (CAMHS) including key implementation issues. This paper aimed to present the findings of the first review that evaluates existing broadband measures of mental health and wellbeing outcomes in terms of these criteria. The following steps were implemented in order to select measures suitable for use in routine practice: literature database searches, consultation with stakeholders, application of inclusion and exclusion criteria, secondary searches and filtering. Subsequently, detailed reviews of the retained measures' psychometric properties and implementation features were carried out. 11 measures were identified as having potential for use in routine practice and meeting most of the key criteria: 1) Achenbach System of Empirically Based Assessment, 2) Beck Youth Inventories, 3) Behavior Assessment System for Children, 4) Behavioral and Emotional Rating Scale, 5) Child Health Questionnaire, 6) Child Symptom Inventories, 7) Health of the National Outcome Scale for Children and Adolescents, 8) Kidscreen, 9) Pediatric Symptom Checklist, 10) Strengths and Difficulties Questionnaire, 11) Youth Outcome Questionnaire. However, all existing measures identified had limitations as well as strengths. Furthermore, none had sufficient psychometric evidence available to demonstrate that they could reliably measure both severity and change over time in key groups. The review suggests a way of rigorously evaluating the growing number of broadband self-report mental health outcome measures against

  2. [Patient evaluation and outcome measures].

    Science.gov (United States)

    Nieto Pol, Enrique

    2014-01-01

    Both the initial evaluation and follow-up of patients with osteoarthritis require systematic evaluation of the indicators that provide information on the degree of involvement of the disease and allow its quantification. Reliable measures of disease progression help decision-making by clinicians and provide valid information on treatment response and the effectiveness of the distinct therapeutic interventions. The instruments recommended in research, as outcome measures in osteoarthritis, are pain evaluation, assessment of physical function, and self-reported global evaluation. In studies lasting more than 1 year, structural changes are evaluated through simple X-ray. Self-reported quality of life assessment and physician global assessment are also recommended as options. These indicators should be incorporated into routine clinical practice for adequate evaluation and correct follow-up of patients with osteoarthritis. The recommended pain evaluation method for use in clinical practice is the visual analog scale (VAS). The best instrument to evaluate physical function in patients with hip or knee osteoarthritis is the WOMAC scale (Western Ontario and McMaster Universities Osteoarthritis Index). For patient-reported global assessment in routine practice, the recommended scales are VAS or the SF-12 (12-item short-form health survey). Copyright © 2014 Elsevier España, S.L. All rights reserved.

  3. Development and validation of MyLifeTracker: a routine outcome measure for youth mental health

    Directory of Open Access Journals (Sweden)

    Kwan B

    2018-04-01

    Full Text Available Benjamin Kwan,1 Debra J Rickwood,1,2 Nic R Telford2 1Faculty of Health, University of Canberra, Bruce, ACT, 2headspace National Youth Mental Health Foundation, Melbourne, VIC, Australia Purpose: Routine outcome measures are now being designed for session-by-session use, with emphasis on clinically meaningful items and sensitivity to change. Despite an increasing mental health service focus for young people aged 12–25 years, there is a lack of outcome measures that are designed to be used across this age group. Consequently, MyLifeTracker (MLT was developed as a brief mental health outcome measure designed for young people for routine use. It consists of the following five items targeting areas of importance to young people: general well-being, day-to-day activities, relationships with friends, relationships with family, and general coping. Participants and methods: The measure was tested with 75,893 young people aged 12–25 years attending headspace centers across Australia for mental health-related issues. Results: MLT showed a robust unidimensional factor structure and appropriate reliability. It exhibited good concurrent validity against well-validated measures of psychological distress, well-being, functioning, and life satisfaction. The measure was further demonstrated to be sensitive to change. Conclusion: MLT provides a psychometrically sound mental health outcome measure for young people. The measure taps into items that are meaningful to young people and provides an additional clinical support tool for clinicians and clients during therapy. The measure is brief and easy to use and has been incorporated into an electronic system that routinely tracks session-by-session change and produces time-series charts for the ease of use and interpretation. Keywords: MyLifeTracker, youth mental health, routine outcome measure, routine outcome monitoring, adolescent and young adult

  4. Engaging the hearts and minds of clinicians in outcome measurement - the UK Rehabilitation Outcomes Collaborative approach.

    Science.gov (United States)

    Turner-Stokes, Lynne; Williams, Heather; Sephton, Keith; Rose, Hilary; Harris, Sarah; Thu, Aung

    2012-01-01

    This article explores the rationale for choosing the instruments included within the UK Rehabilitation Outcomes Collaborative (UKROC) data set. Using one specialist neuro-rehabilitation unit as an exemplar service, it describes an approach to engaging the hearts and minds of clinicians in recording the data. Measures included within a national data set for rehabilitation should be psychometrically robust and feasible to use in routine clinical practice; they should also support clinical decision-making so that clinicians actually want to use them. Learning from other international casemix models and benchmarking data sets, the UKROC team has developed a cluster of measures to inform the development of effective and cost-efficient rehabilitation services. These include measures of (1) "needs" for rehabilitation (complexity), (2) inputs provided to meet those needs (nursing and therapy intervention), and (3) outcome, including the attainment of personal goals as well as gains in functional independence. By integrating the use of the data set measures in everyday clinical practice, we have achieved a very high rate of compliance with data collection. However, staff training and ongoing commitment from senior staff and managers are critical to the maintenance of effort required to provide assurance of data quality in the longer term.

  5. Clinical assessment and patient-reported outcome measures in low-back pain - a survey among primary health care physiotherapists.

    Science.gov (United States)

    Östhols, Sara; Boström, Carina; Rasmussen-Barr, Eva

    2018-05-09

    We aimed to map the physiotherapy practice in Sweden of clinical tests and patient-reported outcome measures in low-back pain (LBP), and to study advantages and barriers in using patient-reported outcome measures. An online survey was mailed to 4934 physiotherapists in primary health care in Sweden. Multiple choice questions investigated the use of clinical tests and patient-reported outcome measures in assessing patients with LBP. Open questions investigating the advantages and barriers to the use of patient-reported outcome measures were analyzed with content analysis. The response rate was 25% (n = 1217). Clinical tests were used "always/often" by >60% of the participants, while most patient-reported outcome measures were used by measures were: the clinical reasoning process, to increase the quality of assessment, to get the patient's voice, education and motivation of patients, and communication with health professionals. Barriers were lack of time and knowledge, administrative aspects, the interaction between physiotherapist and patient and, the applicability and validity of the patient-reported outcome measures. Our findings show that physiotherapists working in primary health care use clinical testing in LBP to a great extent, while various patient-reported outcome measures are used to a low-to-very-low extent. Several barriers to the use of patient-reported outcome measures were reported such as time, knowledge, and administrative issues, while important findings on advantages were to enhance the clinical reasoning process and to educate and motivate the patient. Barriers might be changed through education or organizational change-work. To enhance the use of patient-reported outcome measures and thus person-centered care in low-back pain, recommendation, and education on various patient-reported outcome measures need to be advocated. Implications for rehabilitation To increase the effects of rehabilitation in low-back pain, yellow flags, and other

  6. Prominin-2 expression increases protrusions, decreases caveolae and inhibits Cdc42 dependent fluid phase endocytosis

    Energy Technology Data Exchange (ETDEWEB)

    Singh, Raman Deep, E-mail: Takhter.Ramandeep@mayo.edu; Schroeder, Andreas S.; Scheffer, Luana; Holicky, Eileen L.; Wheatley, Christine L.; Marks, David L., E-mail: Marks.david@mayo.edu; Pagano, Richard E.

    2013-05-10

    Highlights: •Prominin-2 expression induced protrusions that co-localized with lipid raft markers. •Prominin-2 expression decreased caveolae, caveolar endocytosis and increased pCav1. •Prominin-2 expression inhibited fluid phase endocytosis by inactivation of Cdc42. •These endocytic effects can be reversed by adding exogenous cholesterol. •Caveolin1 knockdown restored fluid phase endocytosis in Prominin2 expressing cells. -- Abstract: Background: Membrane protrusions play important roles in biological processes such as cell adhesion, wound healing, migration, and sensing of the external environment. Cell protrusions are a subtype of membrane microdomains composed of cholesterol and sphingolipids, and can be disrupted by cholesterol depletion. Prominins are pentaspan membrane proteins that bind cholesterol and localize to plasma membrane (PM) protrusions. Prominin-1 is of great interest as a marker for stem and cancer cells, while Prominin-2 (Prom2) is reportedly restricted to epithelial cells. Aim: To characterize the effects of Prom-2 expression on PM microdomain organization. Methods: Prom2-fluorescent protein was transfected in human skin fibroblasts (HSF) and Chinese hamster ovary (CHO) cells for PM raft and endocytic studies. Caveolae at PM were visualized using transmission electron microscopy. Cdc42 activation was measured and caveolin-1 knockdown was performed using siRNAs. Results: Prom2 expression in HSF and CHO cells caused extensive Prom2-positive protrusions that co-localized with lipid raft markers. Prom2 expression significantly decreased caveolae at the PM, reduced caveolar endocytosis and increased caveolin-1 phosphorylation. Prom2 expression also inhibited Cdc42-dependent fluid phase endocytosis via decreased Cdc42 activation. Effects on endocytosis were reversed by addition of cholesterol. Knockdown of caveolin-1 by siRNA restored Cdc42 dependent fluid phase endocytosis in Prom2-expressing cells. Conclusions: Prom2 protrusions primarily

  7. Use of continuous glucose monitoring as an outcome measure in clinical trials.

    Science.gov (United States)

    Beck, Roy W; Calhoun, Peter; Kollman, Craig

    2012-10-01

    Although developed to be a management tool for individuals with diabetes, continuous glucose monitoring (CGM) also has potential value for the assessment of outcomes in clinical studies. We evaluated using CGM as such an outcome measure. Data were analyzed from six previously completed inpatient studies in which both CGM (Freestyle Navigator™ [Abbott Diabetes Care, Alameda, CA] or Guardian(®) [Medtronic, Northridge, CA]) and reference glucose measurements were available. The analyses included 97 days of data from 93 participants with type 1 diabetes (age range, 5-57 years; mean, 18 ± 12 years). Mean glucose levels per day were similar for the CGM and reference measurements (median, 148 mg/dL vs. 143 mg/dL, respectively; P = 0.92), and the correlation of the two was high (r = 0.89). Similarly, most glycemia metrics showed no significant differences comparing CGM and reference values, except that the nadir glucose tended to be slightly lower and peak glucose slightly higher with reference measurements than CGM measurements (respective median, 59 mg/dL vs. 66 mg/dL [P = 0.05] and 262 mg/dL vs. 257 mg/dL [P = 0.003]) and glucose variability as measured with the coefficient of variation was slightly lower with CGM than reference measurements (respective median, 31% vs. 35%; Pblood glucose measurements. CGM inaccuracy and underestimation of the extremes of hyperglycemia and hypoglycemia can be accounted for in a clinical trial's study design. Thus, in appropriate settings, CGM can be a very meaningful and feasible outcome measure for clinical trials.

  8. a locally adapted functional outcome measurement score for total

    African Journals Online (AJOL)

    Results and success of total hip arthroplasty are often measured using a functional outcome scoring system. Most current scores were developed in Europe and. North America (1-3). During the evaluation of a Total. Hip Replacement (THR) project in Ouagadougou,. Burkina Faso (4) it was felt that these scores were not.

  9. Framework of outcome measures recommended for use in the evaluation of childhood obesity treatment interventions: the CoOR framework.

    Science.gov (United States)

    Bryant, M; Ashton, L; Nixon, J; Jebb, S; Wright, J; Roberts, K; Brown, J

    2014-12-01

    Consensus is lacking in determining appropriate outcome measures for assessment of childhood obesity treatments. Inconsistency in the use and reporting of such measures impedes comparisons between treatments and limits consideration of effectiveness. This study aimed to produce a framework of recommended outcome measures: the Childhood obesity treatment evaluation Outcomes Review (CoOR) framework. A systematic review including two searches was conducted to identify (1) existing trial outcome measures and (2) manuscripts describing development/evaluation of outcome measures. Outcomes included anthropometry, diet, eating behaviours, physical activity, sedentary time/behaviour, fitness, physiology, environment, psychological well-being and health-related quality of life. Eligible measures were appraised by the internal team using a system developed from international guidelines, followed by appraisal from national external expert collaborators. A total of 25,486 papers were identified through both searches. Eligible search 1 trial papers cited 417 additional papers linked to outcome measures, of which 56 were eligible. A further 297 outcome development/evaluation papers met eligibility criteria from search 2. Combined, these described 191 outcome measures. After internal and external appraisal, 52 measures across 10 outcomes were recommended for inclusion in the CoOR framework. Application of the CoOR framework will ensure greater consistency in choosing robust outcome measures that are appropriate to population characteristics. © 2014 The Authors. Pediatric Obesity © 2014 International Association for the Study of Obesity.

  10. Vaginal microbial flora and outcome of pregnancy.

    Science.gov (United States)

    Donati, Laura; Di Vico, Augusto; Nucci, Marta; Quagliozzi, Lorena; Spagnuolo, Terryann; Labianca, Antonietta; Bracaglia, Marina; Ianniello, Francesca; Caruso, Alessandro; Paradisi, Giancarlo

    2010-04-01

    The vaginal microflora of a healthy asymptomatic woman consists of a wide variety of anaerobic and aerobic bacterial genera and species dominated by the facultative, microaerophilic, anaerobic genus Lactobacillus. The activity of Lactobacillus is essential to protect women from genital infections and to maintain the natural healthy balance of the vaginal flora. Increasing evidence associates abnormalities in vaginal flora during pregnancy with preterm labor and delivery with potential neonatal sequelae due to prematurity and poor perinatal outcome. Although this phenomenon is relatively common, even in populations of women at low risk for adverse events, the pathogenetic mechanism that leads to complications in pregnancy is still poorly understood. This review summarizes the current knowledge and uncertainties in defining alterations of vaginal flora in non-pregnant adult women and during pregnancy, and, in particular, investigates the issue of bacterial vaginosis and aerobic vaginitis. This could help specialists to identify women amenable to treatment during pregnancy leading to the possibility to reduce the preterm birth rate, preterm premature rupture of membranes, chorioamnionitis, neonatal, puerperal and maternal-fetal infectious diseases. Vaginal ecosystem study with the detection of pathogens is a key instrument in the prevention of preterm delivery, pPROM, chorioamnionitis, neonatal, puerperal and maternal-fetal infections.

  11. Goal specificity: a proxy measure for improvements in environmental outcomes in collaborative governance.

    Science.gov (United States)

    Biddle, Jennifer C; Koontz, Tomas M

    2014-12-01

    Collaborative governance critics continually call for evidence to support its prevalent use. As is often the case in environmental policy, environmental outcomes occur at a rate incompatible with political agendas. In addition, a multitude of possibly confounding variables makes it difficult to correlate collaborative governance processes with environmental outcomes. The findings of this study offer empirical evidence that collaborative processes have a measurable, beneficial effect on environmental outcomes. Through the use of a unique paired-waterbody design, our dataset reduced the potential for confounding variables to impact our environmental outcome measurements. The results of a path analysis indicate that the output of setting specific pollutant reduction goals is significantly related to watershed partnerships' level of attainment of their environmental improvement goals. The action of setting specific goals (e.g. percentage of load reductions in pollutant levels) is fostered by sustained participation from partnership members throughout the lifecycle of the collaborative. In addition, this study demonstrates the utility of logic modeling for environmental planning and management, and suggests that the process of setting specific pollutant reduction goals is a useful proxy measure for reporting progress towards improvements in environmental outcomes when long-term environmental data are not available. Copyright © 2014 Elsevier Ltd. All rights reserved.

  12. Ultrasound as an Outcome Measure in Gout. A Validation Process by the OMERACT Ultrasound Working Group

    DEFF Research Database (Denmark)

    Terslev, Lene; Gutierrez, Marwin; Schmidt, Wolfgang A

    2015-01-01

    OBJECTIVE: To summarize the work performed by the Outcome Measures in Rheumatology (OMERACT) Ultrasound (US) Working Group on the validation of US as a potential outcome measure in gout. METHODS: Based on the lack of definitions, highlighted in a recent literature review on US as an outcome tool...

  13. Conservation covenants on private land: issues with measuring and achieving biodiversity outcomes in Australia.

    Science.gov (United States)

    Fitzsimons, James A; Carr, C Ben

    2014-09-01

    Conservation covenants and easements have become essential tools to secure biodiversity outcomes on private land, and to assist in meeting international protection targets. In Australia, the number and spatial area of conservation covenants has grown significantly in the past decade. Yet there has been little research or detailed policy analysis of conservation covenanting in Australia. We sought to determine how conservation covenanting agencies were measuring the biodiversity conservation outcomes achieved on covenanted properties, and factors inhibiting or contributing to measuring these outcomes. In addition, we also investigated the drivers and constraints associated with actually delivering the biodiversity outcomes, drawing on detailed input from covenanting programs. Although all conservation covenanting programs had the broad aim of maintaining or improving biodiversity in their covenants in the long term, the specific stated objectives of conservation covenanting programs varied. Programs undertook monitoring and evaluation in different ways and at different spatial and temporal scales. Thus, it was difficult to determine the extent Australian conservation covenanting agencies were measuring the biodiversity conservation outcomes achieved on covenanted properties on a national scale. Lack of time available to covenantors to undertake management was one of the biggest impediments to achieving biodiversity conservation outcomes. A lack of financial resources and human capital to monitor, knowing what to monitor, inconsistent monitoring methodologies, a lack of benchmark data, and length of time to achieve outcomes were all considered potential barriers to monitoring the biodiversity conservation outcomes of conservation covenants.

  14. Translation of the Ibadan Knee/Hip Osteoarthritis Outcome Measure

    African Journals Online (AJOL)

    Dr Olaleye

    rated by the clinician on five and six (0-5) point ordinal scales. IKHOAM has been ... Igbo translation of Ibadan osteoarthritis outcome measure. 176 .... encourage the use of scales and questionnaires in an .... Validation of a Yoruba translation of the World Health ... Scales: A practical guide to their development and use (1st.

  15. Reliability and validation of the Dutch Achilles tendon Total Rupture Score.

    Science.gov (United States)

    Opdam, K T M; Zwiers, R; Wiegerinck, J I; Kleipool, A E B; Haverlag, R; Goslings, J C; van Dijk, C N

    2018-03-01

    Patient-reported outcome measures (PROMs) have become a cornerstone for the evaluation of the effectiveness of treatment. The Achilles tendon Total Rupture Score (ATRS) is a PROM for outcome and assessment of an Achilles tendon rupture. The aim of this study was to translate the ATRS to Dutch and evaluate its reliability and validity in the Dutch population. A forward-backward translation procedure was performed according to the guidelines of cross-cultural adaptation process. The Dutch ATRS was evaluated for reliability and validity in patients treated for a total Achilles tendon rupture from 1 January 2012 to 31 December 2014 in one teaching hospital and one academic hospital. Reliability was assessed by the intraclass correlation coefficients (ICC), Cronbach's alpha and minimal detectable change (MDC). We assessed construct validity by calculation of Spearman's rho correlation coefficient with domains of the Foot and Ankle Outcome Score (FAOS), Victorian Institute of Sports Assessment-Achilles questionnaire (VISA-A) and Numeric Rating Scale (NRS) for pain in rest and during running. The Dutch ATRS had a good test-retest reliability (ICC = 0.852) and a high internal consistency (Cronbach's alpha = 0.96). MDC was 30.2 at individual level and 3.5 at group level. Construct validity was supported by 75 % of the hypothesized correlations. The Dutch ATRS had a strong correlation with NRS for pain during running (r = -0.746) and all the five subscales of the Dutch FAOS (r = 0.724-0.867). There was a moderate correlation with the VISA-A-NL (r = 0.691) and NRS for pain in rest (r = -0.580). The Dutch ATRS shows an adequate reliability and validity and can be used in the Dutch population for measuring the outcome of treatment of a total Achilles tendon rupture and for research purposes. Diagnostic study, Level I.

  16. Measuring the Effects of Self-Awareness: Construction of the Self-Awareness Outcomes Questionnaire

    Directory of Open Access Journals (Sweden)

    Anna Sutton

    2016-11-01

    Full Text Available Dispositional self-awareness is conceptualized in several different ways, including insight, reflection, rumination and mindfulness, with the latter in particular attracting extensive attention in recent research. While self-awareness is generally associated with positive psychological well-being, these different conceptualizations are also each associated with a range of unique outcomes. This two part, mixed methods study aimed to advance understanding of dispositional self-awareness by developing a questionnaire to measure its outcomes. In Study 1, expert focus groups categorized and extended an initial pool of potential items from previous research. In Study 2, these items were reduced to a 38 item self-report questionnaire with four factors representing three beneficial outcomes (reflective self-development, acceptance and proactivity and one negative outcome (costs. Regression of these outcomes against self-awareness measures revealed that self-reflection and insight predicted beneficial outcomes, rumination predicted reduced benefits and increased costs, and mindfulness predicted both increased proactivity and costs. These studies help to refine the self-awareness concept by identifying the unique outcomes associated with the concepts of self-reflection, insight, reflection, rumination and mindfulness. It can be used in future studies to evaluate and develop awareness-raising techniques to maximize self-awareness benefits while minimizing related costs.

  17. Comparison of Physician-Predicted to Measured Low Vision Outcomes

    Science.gov (United States)

    Chan, Tiffany L.; Goldstein, Judith E.; Massof, Robert W.

    2013-01-01

    Purpose To compare low vision rehabilitation (LVR) physicians’ predictions of the probability of success of LVR to patients’ self-reported outcomes after provision of usual outpatient LVR services; and to determine if patients’ traits influence physician ratings. Methods The Activity Inventory (AI), a self-report visual function questionnaire, was administered pre and post-LVR to 316 low vision patients served by 28 LVR centers that participated in a collaborative observational study. The physical component of the Short Form-36, Geriatric Depression Scale, and Telephone Interview for Cognitive Status were also administered pre-LVR to measure physical capability, depression and cognitive status. Following patient evaluation, 38 LVR physicians estimated the probability of outcome success (POS), using their own criteria. The POS ratings and change in functional ability were used to assess the effects of patients’ baseline traits on predicted outcomes. Results A regression analysis with a hierarchical random effects model showed no relationship between LVR physician POS estimates and AI-based outcomes. In another analysis, Kappa statistics were calculated to determine the probability of agreement between POS and AI-based outcomes for different outcome criteria. Across all comparisons, none of the kappa values were significantly different from 0, which indicates the rate of agreement is equivalent to chance. In an exploratory analysis, hierarchical mixed effects regression models show that POS ratings are associated with information about the patient’s cognitive functioning and the combination of visual acuity and functional ability, as opposed to visual acuity or functional ability alone. Conclusions Physicians’ predictions of LVR outcomes appear to be influenced by knowledge of patients’ cognitive functioning and the combination of visual acuity and functional ability - information physicians acquire from the patient’s history and examination. However

  18. Comparing the responsiveness of functional outcome assessment measures for trauma registries.

    Science.gov (United States)

    Williamson, Owen D; Gabbe, Belinda J; Sutherland, Ann M; Wolfe, Rory; Forbes, Andrew B; Cameron, Peter A

    2011-07-01

    Measuring long-term disability and functional outcomes after major trauma is not standardized across trauma registries. An ideal measure would be responsive to change but not have significant ceiling effects. The aim of this study was to compare the responsiveness of the Glasgow Outcome Scale (GOS), GOS-Extended (GOSE), Functional Independence Measure (FIM), and modified FIM in major trauma patients, with and without significant head injuries. Patients admitted to two adult Level I trauma centers in Victoria, Australia, who survived to discharge from hospital, were aged 15 years to 80 years with a blunt mechanism of injury, and had an estimated Injury Severity Score >15 on admission, were recruited for this prospective study. The instruments were administered at baseline (hospital discharge) and by telephone interview 6 months after injury. Measures of responsiveness, including effect sizes, were calculated. Bootstrapping techniques, and floor and ceiling effects, were used to compare the measures. Two hundred forty-three patients participated, of which 234 patients (96%) completed the study. The GOSE and GOS were the most responsive instruments in this major trauma population with effect sizes of 5.3 and 4.4, respectively. The GOSE had the lowest ceiling effect (17%). The GOSE was the instrument with greatest responsiveness and the lowest ceiling effect in a major trauma population with and without significant head injuries and is recommended for use by trauma registries for monitoring functional outcomes and benchmarking care. The results of this study do not support the use of the modified FIM for this purpose.

  19. Measures of outcome for stimulant trials: ACTTION recommendations and research agenda.

    Science.gov (United States)

    Kiluk, Brian D; Carroll, Kathleen M; Duhig, Amy; Falk, Daniel E; Kampman, Kyle; Lai, Shengan; Litten, Raye Z; McCann, David J; Montoya, Ivan D; Preston, Kenzie L; Skolnick, Phil; Weisner, Constance; Woody, George; Chandler, Redonna; Detke, Michael J; Dunn, Kelly; Dworkin, Robert H; Fertig, Joanne; Gewandter, Jennifer; Moeller, F Gerard; Ramey, Tatiana; Ryan, Megan; Silverman, Kenneth; Strain, Eric C

    2016-01-01

    The development and approval of an efficacious pharmacotherapy for stimulant use disorders has been limited by the lack of a meaningful indicator of treatment success, other than sustained abstinence. In March, 2015, a meeting sponsored by Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) was convened to discuss the current state of the evidence regarding meaningful outcome measures in clinical trials for stimulant use disorders. Attendees included members of academia, funding and regulatory agencies, pharmaceutical companies, and healthcare organizations. The goal was to establish a research agenda for the development of a meaningful outcome measure that may be used as an endpoint in clinical trials for stimulant use disorders. Based on guidelines for the selection of clinical trial endpoints, the lessons learned from prior addiction clinical trials, and the process that led to identification of a meaningful indicator of treatment success for alcohol use disorders, several recommendations for future research were generated. These include a focus on the validation of patient reported outcome measures of functioning, the exploration of patterns of stimulant abstinence that may be associated with physical and/or psychosocial benefits, the role of urine testing for validating self-reported measures of stimulant abstinence, and the operational definitions for reduction-based measures in terms of frequency rather than quantity of stimulant use. These recommendations may be useful for secondary analyses of clinical trial data, and in the design of future clinical trials that may help establish a meaningful indicator of treatment success. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  20. The barriers and facilitators to routine outcome measurement by allied health professionals in practice: a systematic review

    Directory of Open Access Journals (Sweden)

    Duncan Edward AS

    2012-05-01

    Full Text Available Abstract Background Allied Health Professionals today are required, more than ever before, to demonstrate their impact. However, despite at least 20 years of expectation, many services fail to deliver routine outcome measurement in practice. This systematic review investigates what helps and hinders routine outcome measurement of allied health professionals practice. Methods A systematic review protocol was developed comprising: a defined search strategy for PsycINFO, MEDLINE and CINHAL databases and inclusion criteria and systematic procedures for data extraction and quality appraisal. Studies were included if they were published in English and investigated facilitators and/or barriers to routine outcome measurement by allied health professionals. No restrictions were placed on publication type, design, country, or year of publication. Reference lists of included publications were searched to identify additional papers. Descriptive methods were used to synthesise the findings. Results 960 papers were retrieved; 15 met the inclusion criteria. Professional groups represented were Physiotherapy, Occupational Therapy, and Speech and Language Therapy. The included literature varied in quality and design. Facilitators and barriers to routine outcome measurement exist at individual, managerial and organisational levels. Key factors affecting professionals’ use of routine outcome measurement include: professionals’ level of knowledge and confidence about using outcome measures, and the degree of organisational and peer-support professionals received with a view to promoting their work in practice. Conclusions Whilst the importance of routinely measuring outcomes within the allied health professions is well recognised, it has largely failed to be delivered in practice. Factors that influence clinicians’ ability and desire to undertake routine outcome measurement are bi-directional: they can act as either facilitators or barriers. Routine outcome

  1. The patient-specific functional scale: psychometrics, clinimetrics, and application as a clinical outcome measure.

    Science.gov (United States)

    Horn, Katyana Kowalchuk; Jennings, Sophie; Richardson, Gillian; Vliet, Ditte Van; Hefford, Cheryl; Abbott, J Haxby

    2012-01-01

    Systematic review of the literature. To summarize peer-reviewed literature on the reliability, validity, and responsiveness of the Patient-Specific Functional Scale (PSFS), and to identify its use as an outcome measure. Searches were performed of several electronic databases from 1995 to May 2010. Studies included were published articles containing (1) primary research investigating the psychometric and clinimetrics of the PSFS or (2) the implementation of the PSFS as an outcome measure. We assessed the methodological quality of studies included in the first category. Two hundred forty-two articles published from 1994 to May 2010 were identified. Of these, 66 met the inclusion criteria for this review, with 13 reporting the measurement properties of the PSFS, 55 implementing the PSFS as an outcome measure, and 2 doing both of the above. The PSFS was reported to be valid, reliable, and responsive in populations with knee dysfunction, cervical radiculopathy, acute low back pain, mechanical low back pain, and neck dysfunction. The PSFS was found to be reliable and responsive in populations with chronic low back pain. The PSFS was also reported to be valid, reliable, or responsive in individuals with a limited number of acute, subacute, and chronic conditions. This review found that the PSFS is also being used as an outcome measure in many other conditions, despite a lack of published evidence supporting its validity in these conditions. Although the use of the PSFS as an outcome measure is increasing in physiotherapy practice, there are gaps in the research literature regarding its validity, reliability, and responsiveness in many health conditions.

  2. Multiple Measures of Outcome in Assessing a Prison-Based Drug Treatment Program

    Science.gov (United States)

    Prendergast, Michael L.; Hall, Elizabeth A.; Wexler, Harry K.

    2003-01-01

    Evaluations of prison-based drug treatment programs typically focus on one or two dichotomous outcome variables related to recidivism. In contrast, this paper uses multiple measures of outcomes related to crime and drug use to examine the impact of prison treatment. Crime variables included self-report data of time to first illegal activity,…

  3. Stable Fixation of a Cementless, Proximally Coated, Double Wedged, Double Tapered Femoral Stem in Total Hip Arthroplasty

    DEFF Research Database (Denmark)

    Nebergall, Audrey K; Rolfson, Ola; Rubash, Harry E

    2016-01-01

    BACKGROUND: The objective of this 5-year prospective study of 51 hips was to assess migration of a cementless tapered femoral stem using radiostereometric analysis (RSA), plain radiographs (radiolucencies), and patient-reported outcome measures (PROMs). METHODS: Forty-seven patients (51 hips...... year remain stable at 5 years. RSA was the most sensitive method of detection for stems at greater risk for potential future failure. This report adds contributions to the positive results associated with this type of fixation. The results at 5 years showed excellent midterm survivorship in this cohort...

  4. Measuring public health practice and outcomes in chronic disease: a call for coordination.

    Science.gov (United States)

    Porterfield, Deborah S; Rogers, Todd; Glasgow, LaShawn M; Beitsch, Leslie M

    2015-04-01

    A strategic opportunity exists to coordinate public health systems and services researchers' efforts to develop local health department service delivery measures and the efforts of divisions within the Centers for Disease Control and Prevention's National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) to establish outcome indicators for public health practice in chronic disease. Several sets of outcome indicators developed by divisions within NCCDPHP and intended for use by state programs can be tailored to assess outcomes of interventions within smaller geographic areas or intervention settings. Coordination of measurement efforts could potentially allow information to flow from the local to the state to the federal level, enhancing program planning, accountability, and even subsequent funding for public health practice.

  5. Patient-reported outcome measures in burning mouth syndrome - a review of the literature.

    Science.gov (United States)

    Ni Riordain, R; McCreary, C

    2013-04-01

    Oral Diseases (2013) 19, 230-235 This review aims to investigate the patient-reported outcomes currently used in the burning mouth syndrome literature and to explore whether any standardisation of such measures has taken place. Electronic databases were searched for all types of burning mouth syndrome studies using patient-reported outcome measures. Studies were selected by predefined inclusion criteria. Copies of the papers obtained were thoroughly reviewed. A study-specific data extraction form was used, allowing papers to be reviewed in a standardised manner. The initial literature search yielded a total of 173 citations, 43 of which were deemed suitable for inclusion in this study. Symptom severity and symptomatic relief were reported as a patient-reported outcome measure in 40 of the studies and quantified most commonly using a visual analogue scale. Quality of life was reported in 13 studies included in this review. Depression and/or anxiety was reported in 14 of the studies. As is evident from the variety of questionnaires and instruments used in the evaluation of the impact of burning mouth syndrome on patients' lives, no standardisation of patient outcomes has yet been achieved. © 2012 John Wiley & Sons A/S.

  6. Exploring Outcome Measures for Exercise Intervention in People with Parkinson’s Disease

    Directory of Open Access Journals (Sweden)

    L. A. King

    2013-01-01

    Full Text Available Background. It is widely believed that exercise improves mobility in people with Parkinson’s disease (PD. However, it is difficult to determine whether a specific type of exercise is the most effective. The purpose of this study was to determine which outcome measures were sensitive to exercise intervention and to explore the effects of two different exercise programs for improving mobility in patients with PD. Methods. Participants were randomized into either the Agility Boot Camp (ABC or treadmill training; 4x/week for 4 weeks. Outcome measures were grouped by the International Classification of Function/Disability (ICF. To determine the responsiveness to exercise, we calculated the standardized response means. t-tests were used to compare the relative benefits of each exercise program. Results. Four of five variables at the structure/function level changed after exercise: turn duration (P=0.03, stride velocity (P=0.001, peak arm speed (P=0.001, and horizontal trunk ROM during gait (P=0.02. Most measures improved similarly for both interventions. The only variable that detected a difference between groups was postural sway in ABC group (F=4.95; P=0.03. Conclusion. Outcome measures at ICF body structure/function level were most effective at detecting change after exercise and revealing differences in improvement between interventions.

  7. Should we all go to the PROM? The first two years of the British Spine Registry.

    Science.gov (United States)

    Breakwell, L M; Cole, A A; Birch, N; Heywood, C

    2015-07-01

    The effective capture of outcome measures in the healthcare setting can be traced back to Florence Nightingale's investigation of the in-patient mortality of soldiers wounded in the Crimean war in the 1850s. Only relatively recently has the formalised collection of outcomes data into Registries been recognised as valuable in itself. With the advent of surgeon league tables and a move towards value based health care, individuals are being driven to collect, store and interpret data. Following the success of the National Joint Registry, the British Association of Spine Surgeons instituted the British Spine Registry. Since its launch in 2012, over 650 users representing the whole surgical team have registered and during this time, more than 27 000 patients have been entered onto the database. There has been significant publicity regarding the collection of outcome measures after surgery, including patient-reported scores. Over 12 000 forms have been directly entered by patients themselves, with many more entered by the surgical teams. Questions abound: who should have access to the data produced by the Registry and how should they use it? How should the results be reported and in what forum? ©2015 The British Editorial Society of Bone & Joint Surgery.

  8. Does restoration of focal lumbar lordosis for single level degenerative spondylolisthesis result in better patient-reported clinical outcomes? A systematic literature review.

    Science.gov (United States)

    Rhee, Chanseok; Visintini, Sarah; Dunning, Cynthia E; Oxner, William M; Glennie, R Andrew

    2017-10-01

    It is controversial whether the surgical restoration of sagittal balance and spinopelvic angulation in a single level lumbar degenerative spondylolisthesis results in clinical improvements. The purpose of this study to systematically review the available literature to determine whether the surgical correction of malalignment in lumbar degenerative spondylolisthesis correlates with improvements in patient-reported clinical outcomes. Literature searches were performed via Ovid Medline, Embase, CENTRAL and Web of Science using search terms "lumbar," "degenerative/spondylolisthesis" and "surgery/surgical/surgeries/fusion". This resulted in 844 articles and after reviewing the abstracts and full-texts, 13 articles were included for summary and final analysis. There were two Level II articles, four Level III articles and five Level IV articles. Most commonly used patient-reported outcome measures (PROMs) were Oswestery disability index (ODI) and visual analogue scale (VAS). Four articles were included for the final statistical analysis. There was no statistically significant difference between the patient groups who achieved successful surgical correction of malalignment and those who did not for either ODI (mean difference -0.94, CI -8.89-7.00) or VAS (mean difference 1.57, CI -3.16-6.30). Two studies assessed the efficacy of manual reduction of lumbar degenerative spondylolisthesis and their clinical outcomes after the operation, and there was no statistically significant improvement. Overall, the restoration of focal lumbar lordosis and restoration of sagittal balance for single-level lumbar degenerative spondylolisthesis does not seem to yield clinical improvements but well-powered studies on this specific topic is lacking in the current literature. Future well-powered studies are needed for a more definitive conclusion. Copyright © 2017 Elsevier Ltd. All rights reserved.

  9. Do Activity Level Outcome Measures Commonly Used in Neurological Practice Assess Upper-Limb Movement Quality?

    Science.gov (United States)

    Demers, Marika; Levin, Mindy F

    2017-07-01

    Movement is described in terms of task-related end point characteristics in external space and movement quality (joint rotations in body space). Assessment of upper-limb (UL) movement quality can assist therapists in designing effective treatment approaches for retraining lost motor elements and provide more detailed measurements of UL motor improvements over time. To determine the extent to which current activity level outcome measures used in neurological practice assess UL movement quality. Outcome measures assessing arm/hand function at the International Classification of Function activity level recommended by neurological clinical practice guidelines were reviewed. Measures assessing the UL as part of a general mobility assessment, those strictly evaluating body function/structure or participation, and paediatric measures were excluded. In all, 15 activity level outcome measures were identified; 9 measures assess how movement is performed by measuring either end point characteristics or movement quality. However, except for the Reaching Performance Scale for Stroke and the Motor Evaluation Scale for Upper Extremity in Stroke Patients, these measures only account for deficits indirectly by giving a partial score if movements are slower or if the person experiences difficulties. Six outcome measures neither assess any parameters related to movement quality, nor distinguish between improvements resulting from motor compensation or recovery of desired movement strategies. Current activity measures may not distinguish recovery from compensation and adequately track changes in movement quality over time. Movement quality may be incorporated into clinical assessment using observational kinematics with or without low-cost motion tracking technology.

  10. CT Measured Psoas Density Predicts Outcomes After Enterocutaneous Fistula Repair

    Science.gov (United States)

    Lo, Wilson D.; Evans, David C.; Yoo, Taehwan

    2018-01-01

    Background Low muscle mass and quality are associated with poor surgical outcomes. We evaluated CT measured psoas muscle density as a marker of muscle quality and physiologic reserve, and hypothesized that it would predict outcomes after enterocutaneous fistula repair (ECF). Methods We conducted a retrospective cohort study of patients 18 – 90 years old with ECF failing non-operative management requiring elective operative repair at Ohio State University from 2005 – 2016 that received a pre-operative abdomen/pelvis CT with intravenous contrast within 3 months of their operation. Psoas Hounsfield Unit average calculation (HUAC) were measured at the L3 level. 1 year leak rate, 90 day, 1 year, and 3 year mortality, complication risk, length of stay, dependent discharge, and 30 day readmission were compared to HUAC. Results 100 patients met inclusion criteria. Patients were stratified into interquartile (IQR) ranges based on HUAC. The lowest HUAC IQR was our low muscle quality (LMQ) cutoff, and was associated with 1 year leak (OR 3.50, p < 0.01), 1 year (OR 2.95, p < 0.04) and 3 year mortality (OR 3.76, p < 0.01), complication risk (OR 14.61, p < 0.01), and dependent discharge (OR 4.07, p < 0.01) compared to non-LMQ patients. Conclusions Psoas muscle density is a significant predictor of poor outcomes in ECF repair. This readily available measure of physiologic reserve can identify patients with ECF on pre-operative evaluation that have significantly increased risk that may benefit from additional interventions and recovery time to mitigate risk before operative repair. PMID:29505144

  11. Outcome-driven thresholds for home blood pressure measurement: international database of home blood pressure in relation to cardiovascular outcome.

    Science.gov (United States)

    Niiranen, Teemu J; Asayama, Kei; Thijs, Lutgarde; Johansson, Jouni K; Ohkubo, Takayoshi; Kikuya, Masahiro; Boggia, José; Hozawa, Atsushi; Sandoya, Edgardo; Stergiou, George S; Tsuji, Ichiro; Jula, Antti M; Imai, Yutaka; Staessen, Jan A

    2013-01-01

    The lack of outcome-driven operational thresholds limits the clinical application of home blood pressure (BP) measurement. Our objective was to determine an outcome-driven reference frame for home BP measurement. We measured home and clinic BP in 6470 participants (mean age, 59.3 years; 56.9% women; 22.4% on antihypertensive treatment) recruited in Ohasama, Japan (n=2520); Montevideo, Uruguay (n=399); Tsurugaya, Japan (n=811); Didima, Greece (n=665); and nationwide in Finland (n=2075). In multivariable-adjusted analyses of individual subject data, we determined home BP thresholds, which yielded 10-year cardiovascular risks similar to those associated with stages 1 (120/80 mm Hg) and 2 (130/85 mm Hg) prehypertension, and stages 1 (140/90 mm Hg) and 2 (160/100 mm Hg) hypertension on clinic measurement. During 8.3 years of follow-up (median), 716 cardiovascular end points, 294 cardiovascular deaths, 393 strokes, and 336 cardiac events occurred in the whole cohort; in untreated participants these numbers were 414, 158, 225, and 194, respectively. In the whole cohort, outcome-driven systolic/diastolic thresholds for the home BP corresponding with stages 1 and 2 prehypertension and stages 1 and 2 hypertension were 121.4/77.7, 127.4/79.9, 133.4/82.2, and 145.4/86.8 mm Hg; in 5018 untreated participants, these thresholds were 118.5/76.9, 125.2/79.7, 131.9/82.4, and 145.3/87.9 mm Hg, respectively. Rounded thresholds for stages 1 and 2 prehypertension and stages 1 and 2 hypertension amounted to 120/75, 125/80, 130/85, and 145/90 mm Hg, respectively. Population-based outcome-driven thresholds for home BP are slightly lower than those currently proposed in hypertension guidelines. Our current findings could inform guidelines and help clinicians in diagnosing and managing patients.

  12. Spatial cluster detection for repeatedly measured outcomes while accounting for residential history.

    Science.gov (United States)

    Cook, Andrea J; Gold, Diane R; Li, Yi

    2009-10-01

    Spatial cluster detection has become an important methodology in quantifying the effect of hazardous exposures. Previous methods have focused on cross-sectional outcomes that are binary or continuous. There are virtually no spatial cluster detection methods proposed for longitudinal outcomes. This paper proposes a new spatial cluster detection method for repeated outcomes using cumulative geographic residuals. A major advantage of this method is its ability to readily incorporate information on study participants relocation, which most cluster detection statistics cannot. Application of these methods will be illustrated by the Home Allergens and Asthma prospective cohort study analyzing the relationship between environmental exposures and repeated measured outcome, occurrence of wheeze in the last 6 months, while taking into account mobile locations.

  13. Engaging the hearts and minds of clinicians in outcome measurement – the UK rehabilitation outcomes collaborative approach

    Science.gov (United States)

    2012-01-01

    Purpose This article explores the rationale for choosing the instruments included within the UK Rehabilitation Outcomes Collaborative (UKROC) data set. Using one specialist neuro-rehabilitation unit as an exemplar service, it describes an approach to engaging the hearts and minds of clinicians in recording the data. Key messages and implications Measures included within a national data set for rehabilitation should be psychometrically robust and feasible to use in routine clinical practice; they should also support clinical decision-making so that clinicians actually want to use them. Learning from other international casemix models and benchmarking data sets, the UKROC team has developed a cluster of measures to inform the development of effective and cost-efficient rehabilitation services. These include measures of (1) “needs” for rehabilitation (complexity), (2) inputs provided to meet those needs (nursing and therapy intervention), and (3) outcome, including the attainment of personal goals as well as gains in functional independence. Conclusions By integrating the use of the data set measures in everyday clinical practice, we have achieved a very high rate of compliance with data collection. However, staff training and ongoing commitment from senior staff and managers are critical to the maintenance of effort required to provide assurance of data quality in the longer term. PMID:22506959

  14. Treatment of patients with hand osteoarthritis : outcome measures, patient satisfaction, and economic evaluation

    NARCIS (Netherlands)

    Marks, Miriam

    2014-01-01

    The aim of this thesis was to investigate the limitations in daily life, outcome measures, clinical outcomes with the emphasis on patient satisfaction, and economic aspects of the treatment of hand osteoarthritis (OA). Patients with hand OA report severe restrictions in daily life, in particular in

  15. Progress Towards a Core Set of Outcome Measures in Small-vessel Vasculitis. Report from OMERACT 9

    Science.gov (United States)

    MERKEL, PETER A.; HERLYN, KAREN; MAHR, ALFRED D.; NEOGI, TUHINA; SEO, PHILIP; WALSH, MICHAEL; BOERS, MAARTEN; LUQMANI, RAASHID

    2011-01-01

    The past decade has seen a substantial increase in the number and quality of clinical trials of new therapies for vasculitis, including randomized, controlled, multicenter trials that have successfully incorporated measures of disease activity and toxicity. However, because current treatment regimens for severe disease effectively induce initial remission and reduce mortality, future trials will focus on any of several goals including: (a) treatment of mild—moderate disease; (b) prevention of chronic damage; (c) reduction in treatment toxicity; or (d) more subtle differences in remission induction or maintenance. Thus, new trials will require outcome measure instruments that are more precise and are better able to detect effective treatments for different disease states and measure chronic manifestations of disease. The OMERACT Vasculitis Working Group comprises international clinical investigators with expertise in vasculitis who, since 2002, have worked collaboratively to advance the refinement of outcome measures in vasculitis, create new measures to address domains of illness not covered by current research approaches, and harmonize outcome assessment in vasculitis. The focus of the OMERACT group to date has been on outcome measures in small-vessel vasculitis with an overall goal of creating a core set of outcome measures for vasculitis, each of which fulfills the OMERACT filter of truth, discrimination, feasibility, and identifying additional domains requiring further research. This process has been informed by several ongoing projects providing data on outcomes of disease activity, disease-related damage, multidimensional health-related quality of life, and patient-reported ratings of the burden of vasculitis. PMID:19820226

  16. Effect of Ankle Range of Motion (ROM) and Lower-Extremity Muscle Strength on Static Balance Control Ability in Young Adults: A Regression Analysis

    Science.gov (United States)

    Kim, Seong-Gil

    2018-01-01

    Background The purpose of this study was to investigate the effect of ankle ROM and lower-extremity muscle strength on static balance control ability in young adults. Material/Methods This study was conducted with 65 young adults, but 10 young adults dropped out during the measurement, so 55 young adults (male: 19, female: 36) completed the study. Postural sway (length and velocity) was measured with eyes open and closed, and ankle ROM (AROM and PROM of dorsiflexion and plantarflexion) and lower-extremity muscle strength (flexor and extensor of hip, knee, and ankle joint) were measured. Pearson correlation coefficient was used to examine the correlation between variables and static balance ability. Simple linear regression analysis and multiple linear regression analysis were used to examine the effect of variables on static balance ability. Results In correlation analysis, plantarflexion ROM (AROM and PROM) and lower-extremity muscle strength (except hip extensor) were significantly correlated with postural sway (pregression analysis, plantar flexion PROM with eyes open significantly influenced sway length (B=0.681) and sway velocity (B=0.011). Conclusions Lower-extremity muscle strength and ankle plantarflexion ROM influenced static balance control ability, with ankle plantarflexion PROM showing the greatest influence. Therefore, both contractile structures and non-contractile structures should be of interest when considering static balance control ability improvement. PMID:29760375

  17. Aging of intrauterine tissues in spontaneous preterm birth and preterm premature rupture of the membranes: A systematic review of the literature.

    Science.gov (United States)

    Polettini, J; Dutta, E H; Behnia, F; Saade, G R; Torloni, M R; Menon, R

    2015-09-01

    Many adverse pregnancy outcomes (APOs), including spontaneous preterm birth (PTB), are associated with placental dysfunction. Recent clinical and experimental evidences suggest that premature aging of the placenta may be involved in these events. Although placental aging is a well-known concept, the mechanisms of aging during normal pregnancy and premature aging in APOs are still unclear. This review was conducted to assess the knowledge on placental aging related biochemical changes leading to placental dysfunction in PTB and/or preterm premature rupture of membranes (pPROM). We performed a systematic review of studies published over the last 50 years in two electronic databases (Pubmed and Embase) on placental aging and PTB or pPROM. The search yielded 554 citations, 30 relevant studies were selected for full-text review and three were included in the review. Only one study reported oxidative stress-related aging and degenerative changes in human placental membranes and telomere length reduction in fetal cells as part of PTB and/or pPROM mechanisms. Similarly, two animal studies reported findings of decidual senescence and referred to PTB mechanisms. Placental and fetal membrane oxidative damage and telomere reduction are linked to premature aging in PTB and pPROM but the risk factors and biomolecular pathways causing this phenomenon are not established in the literature. However, no biomarkers or clinical indicators of premature aging as a pathology of PTB and pPROM have been reported. We document major knowledge gaps and propose several areas for future research to improve our understanding of premature aging linked to placental dysfunction. Copyright © 2015 Elsevier Ltd. All rights reserved.

  18. No common denominator: a review of outcome measures in IVF RCTs.

    Science.gov (United States)

    Wilkinson, Jack; Roberts, Stephen A; Showell, Marian; Brison, Daniel R; Vail, Andy

    2016-12-01

    Which outcome measures are reported in RCTs for IVF? Many combinations of numerator and denominator are in use, and are often employed in a manner that compromises the validity of the study. The choice of numerator and denominator governs the meaning, relevance and statistical integrity of a study's results. RCTs only provide reliable evidence when outcomes are assessed in the cohort of randomised participants, rather than in the subgroup of patients who completed treatment. Review of outcome measures reported in 142 IVF RCTs published in 2013 or 2014. Trials were identified by searching the Cochrane Gynaecology and Fertility Specialised Register. English-language publications of RCTs reporting clinical or preclinical outcomes in peer-reviewed journals in the period 1 January 2013 to 31 December 2014 were eligible. Reported numerators and denominators were extracted. Where they were reported, we checked to see if live birth rates were calculated correctly using the entire randomised cohort or a later denominator. Over 800 combinations of numerator and denominator were identified (613 in no more than one study). No single outcome measure appeared in the majority of trials. Only 22 (43%) studies reporting live birth presented a calculation including all randomised participants or only excluding protocol violators. A variety of definitions were used for key clinical numerators: for example, a consensus regarding what should constitute an ongoing pregnancy does not appear to exist at present. Several of the included articles may have been secondary publications. Our categorisation scheme was essentially arbitrary, so the frequencies we present should be interpreted with this in mind. The analysis of live birth denominators was post hoc. There is massive diversity in numerator and denominator selection in IVF trials due to its multistage nature, and this causes methodological frailty in the evidence base. The twin spectres of outcome reporting bias and analysis of non

  19. How do aggregated patient-reported outcome measures data stimulate health care improvement? A realist synthesis

    Science.gov (United States)

    Dalkin, Sonia; Gibbons, Elizabeth; Wright, Judy; Valderas, Jose Maria; Meads, David; Black, Nick

    2017-01-01

    Objectives Internationally, there has been considerable debate about the role of data in supporting quality improvement in health care. Our objective was to understand how, why and in what circumstances the feedback of aggregated patient-reported outcome measures data improved patient care. Methods We conducted a realist synthesis. We identified three main programme theories underlying the use of patient-reported outcome measures as a quality improvement strategy and expressed them as nine ‘if then’ propositions. We identified international evidence to test these propositions through searches of electronic databases and citation tracking, and supplemented our synthesis with evidence from similar forms of performance data. We synthesized this evidence through comparing the mechanisms and impact of patient-reported outcome measures and other performance data on quality improvement in different contexts. Results Three programme theories were identified: supporting patient choice, improving accountability and enabling providers to compare their performance with others. Relevant contextual factors were extent of public disclosure, use of financial incentives, perceived credibility of the data and the practicality of the results. Available evidence suggests that patients or their agents rarely use any published performance data when selecting a provider. The perceived motivation behind public reporting is an important determinant of how providers respond. When clinicians perceived that performance indicators were not credible but were incentivized to collect them, gaming or manipulation of data occurred. Outcome data do not provide information on the cause of poor care: providers needed to integrate and interpret patient-reported outcome measures and other outcome data in the context of other data. Lack of timeliness of performance data constrains their impact. Conclusions Although there is only limited research evidence to support some widely held theories of how

  20. Innovating for quality and value: Utilizing national quality improvement programs to identify opportunities for responsible surgical innovation.

    Science.gov (United States)

    Woo, Russell K; Skarsgard, Erik D

    2015-06-01

    Innovation in surgical techniques, technology, and care processes are essential for improving the care and outcomes of surgical patients, including children. The time and cost associated with surgical innovation can be significant, and unless it leads to improvements in outcome at equivalent or lower costs, it adds little or no value from the perspective of the patients, and decreases the overall resources available to our already financially constrained healthcare system. The emergence of a safety and quality mandate in surgery, and the development of the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) allow needs-based surgical care innovation which leads to value-based improvement in care. In addition to general and procedure-specific clinical outcomes, surgeons should consider the measurement of quality from the patients' perspective. To this end, the integration of validated Patient Reported Outcome Measures (PROMs) into actionable, benchmarked institutional outcomes reporting has the potential to facilitate quality improvement in process, treatment and technology that optimizes value for our patients and health system. Copyright © 2015 Elsevier Inc. All rights reserved.

  1. Directly measured secondhand smoke exposure and COPD health outcomes

    Directory of Open Access Journals (Sweden)

    Balmes John

    2006-06-01

    Full Text Available Abstract Background Although personal cigarette smoking is the most important cause and modulator of chronic obstructive pulmonary disease (COPD, secondhand smoke (SHS exposure could influence the course of the disease. Despite the importance of this question, the impact of SHS exposure on COPD health outcomes remains unknown. Methods We used data from two waves of a population-based multiwave U.S. cohort study of adults with COPD. 77 non-smoking respondents with a diagnosis of COPD completed direct SHS monitoring based on urine cotinine and a personal badge that measures nicotine. We evaluated the longitudinal impact of SHS exposure on validated measures of COPD severity, physical health status, quality of life (QOL, and dyspnea measured at one year follow-up. Results The highest level of SHS exposure, as measured by urine cotinine, was cross-sectionally associated with poorer COPD severity (mean score increment 4.7 pts; 95% CI 0.6 to 8.9 and dyspnea (1.0 pts; 95% CI 0.4 to 1.7 after controlling for covariates. In longitudinal analysis, the highest level of baseline cotinine was associated with worse COPD severity (4.7 points; 95% CI -0.1 to 9.4; p = 0.054, disease-specific QOL (2.9 pts; -0.16 to 5.9; p = 0.063, and dyspnea (0.9 pts; 95% CI 0.2 to 1.6 pts; p Conclusion Directly measured SHS exposure appears to adversely influence health outcomes in COPD, independent of personal smoking. Because SHS is a modifiable risk factor, clinicians should assess SHS exposure in their patients and counsel its avoidance. In public health terms, the effects of SHS exposure on this vulnerable subpopulation provide a further rationale for laws prohibiting public smoking.

  2. Patient-reported outcomes (PROs): the significance of using humanistic measures in clinical trial and clinical practice.

    Science.gov (United States)

    Refolo, P; Minacori, R; Mele, V; Sacchini, D; Spagnolo, A G

    2012-10-01

    Patient-reported outcome (PRO) is an "umbrella term" that covers a whole range of potential types of measurement but it is used specifically to refer to all measures quantifying the state of health through the evaluation of outcomes reported by the patient himself/herself. PROs are increasingly seen as complementary to biomedical measures and they are being incorporated more frequently into clinical trials and clinical practice. After considering the cultural background of PROs - that is the well known patient-centered model of medicine -, their historical profile (since 1914, the year of the first outcome measure) and typologies, the paper aims at debating their methodological complexity and implementation into practice. Some clinical trials and therapeutic managements utilizing patient-centered measures will be also analyzed.

  3. Measurement properties of the Health of the Nation Outcome Scales (HoNOS) family of measures: protocol for a systematic review

    Science.gov (United States)

    Harris, Meredith G; Sparti, Claudia; Scheurer, Roman; Coombs, Tim; Pirkis, Jane; Ruud, Torleif; Kisely, Steve; Hanssen-Bauer, Ketil; Siqveland, Johan; Burgess, Philip M

    2018-01-01

    Introduction The Health of the Nation Outcome Scales (HoNOS) for adults, and equivalent measures for children and adolescents and older people, are widely used in clinical practice and research contexts to measure mental health and functional outcomes. Additional HoNOS measures have been developed for special populations and applications. Stakeholders require synthesised information about the measurement properties of these measures to assess whether they are fit for use with intended service settings and populations and to establish performance benchmarks. This planned systematic review will critically appraise evidence on the measurement properties of the HoNOS family of measures. Methods and analysis Journal articles meeting inclusion criteria will be identified via a search of seven electronic databases: MEDLINE via EBSCOhost, PsycINFO via APA PsycNET, Embase via Elsevier, Cumulative Index to Nursing and Allied Health Literature via EBSCOhost, Web of Science via Thomson Reuters, Google Scholar and the Cochrane Library. Variants of ‘Health of the Nation Outcome Scales’ or ‘HoNOS’ will be searched as text words. No restrictions will be placed on setting or language of publication. Reference lists of relevant studies and reviews will be scanned for additional eligible studies. Appraisal of reliability, validity, responsiveness and interpretability will be guided by the COnsensus-based Standards for the selection of health Measurement INstruments checklist. Feasibility/utility will be appraised using definitions and criteria derived from previous reviews. For reliability studies, we will also apply the Guidelines for Reporting Reliability and Agreement Studies to assess quality of reporting. Results will be synthesised narratively, separately for each measure, and by subgroup (eg, treatment setting, rater profession/experience or training) where possible. Meta-analyses will be undertaken where data are adequate. Ethics and dissemination Ethics approval is

  4. Measurement properties of the Health of the Nation Outcome Scales (HoNOS) family of measures: protocol for a systematic review.

    Science.gov (United States)

    Harris, Meredith G; Sparti, Claudia; Scheurer, Roman; Coombs, Tim; Pirkis, Jane; Ruud, Torleif; Kisely, Steve; Hanssen-Bauer, Ketil; Siqveland, Johan; Burgess, Philip M

    2018-04-20

    The Health of the Nation Outcome Scales (HoNOS) for adults, and equivalent measures for children and adolescents and older people, are widely used in clinical practice and research contexts to measure mental health and functional outcomes. Additional HoNOS measures have been developed for special populations and applications. Stakeholders require synthesised information about the measurement properties of these measures to assess whether they are fit for use with intended service settings and populations and to establish performance benchmarks. This planned systematic review will critically appraise evidence on the measurement properties of the HoNOS family of measures. Journal articles meeting inclusion criteria will be identified via a search of seven electronic databases: MEDLINE via EBSCOhost, PsycINFO via APA PsycNET, Embase via Elsevier, Cumulative Index to Nursing and Allied Health Literature via EBSCOhost, Web of Science via Thomson Reuters, Google Scholar and the Cochrane Library. Variants of 'Health of the Nation Outcome Scales' or 'HoNOS' will be searched as text words. No restrictions will be placed on setting or language of publication. Reference lists of relevant studies and reviews will be scanned for additional eligible studies. Appraisal of reliability, validity, responsiveness and interpretability will be guided by the COnsensus-based Standards for the selection of health Measurement INstruments checklist. Feasibility/utility will be appraised using definitions and criteria derived from previous reviews. For reliability studies, we will also apply the Guidelines for Reporting Reliability and Agreement Studies to assess quality of reporting. Results will be synthesised narratively, separately for each measure, and by subgroup (eg, treatment setting, rater profession/experience or training) where possible. Meta-analyses will be undertaken where data are adequate. Ethics approval is not required as no primary data will be collected. Outcomes will be

  5. Alzheimer Disease Biomarkers as Outcome Measures for Clinical Trials in MCI.

    Science.gov (United States)

    Caroli, Anna; Prestia, Annapaola; Wade, Sara; Chen, Kewei; Ayutyanont, Napatkamon; Landau, Susan M; Madison, Cindee M; Haense, Cathleen; Herholz, Karl; Reiman, Eric M; Jagust, William J; Frisoni, Giovanni B

    2015-01-01

    The aim of this study was to compare the performance and power of the best-established diagnostic biological markers as outcome measures for clinical trials in patients with mild cognitive impairment (MCI). Magnetic resonance imaging, F-18 fluorodeoxyglucose positron emission tomography markers, and Alzheimer's Disease Assessment Scale-cognitive subscale were compared in terms of effect size and statistical power over different follow-up periods in 2 MCI groups, selected from Alzheimer's Disease Neuroimaging Initiative data set based on cerebrospinal fluid (abnormal cerebrospinal fluid Aβ1-42 concentration-ABETA+) or magnetic resonance imaging evidence of Alzheimer disease (positivity to hippocampal atrophy-HIPPO+). Biomarkers progression was modeled through mixed effect models. Scaled slope was chosen as measure of effect size. Biomarkers power was estimated using simulation algorithms. Seventy-four ABETA+ and 51 HIPPO+ MCI patients were included in the study. Imaging biomarkers of neurodegeneration, especially MR measurements, showed highest performance. For all biomarkers and both MCI groups, power increased with increasing follow-up time, irrespective of biomarker assessment frequency. These findings provide information about biomarker enrichment and outcome measurements that could be employed to reduce MCI patient samples and treatment duration in future clinical trials.

  6. Mother-to-child transmission of human immunodeficiency virus (HIV) among HIV-infected pregnant women on highly active anti-retroviral therapy with premature rupture of membranes at term.

    Science.gov (United States)

    Eleje, George Uchenna; Edokwe, Emeka Stephen; Ikechebelu, Joseph Ifeanyichukwu; Onubogu, Chinyere Ukamaka; Ugochukwu, Ebele Francesca; Okam, Princeston Chukwuemeka; Ibekwe, Adaobi Maryann

    2018-01-01

    To determine mother-to-child transmission (MTCT) rate and associated risk factors of human immune-deficiency virus (HIV) among HIV-infected pregnant women with term premature rupture of membranes (PROM) in comparison with those without PROM at term. All optimally managed HIV-positive pregnant women of Nnamdi Azikiwe University Teaching Hospital, on highly active anti-retroviral therapy (HAART) who had PROM at term were enrolled. Maternal HIV-1 viral load was not assessed. Follow up was for a minimum of 18 months for evidence of HIV infection. Of the 121 women with PROM at term, 46 (38.0%) were HIV sero-positive, 22/46 (47.8%) of which had their babies followed up till 18 months. The mean latency period was 10.5 ± 5.3 h in PROM group. Apart from duration of PROM (OR = 0.01; 95%CI = 0.00-0.13; p  0.05). Of the 22 (47.8%) babies followed-up in the PROM group and 13 in non-PROM group, none tested positive to HIV, given an MTCT rate of 0%. MTCT rate was 0% following term PROM and in women without PROM. Since maternal HIV-1 viral load was not assessed, we need to be critical while interpreting the findings.

  7. Recommendations for a first Core Outcome Measurement set for complex regional PAin syndrome Clinical sTudies (COMPACT)

    Science.gov (United States)

    Grieve, Sharon; Perez, Roberto SGM; Birklein, Frank; Brunner, Florian; Bruehl, Stephen; Harden R, Norman; Packham, Tara; Gobeil, Francois; Haigh, Richard; Holly, Janet; Terkelsen, Astrid; Davies, Lindsay; Lewis, Jennifer; Thomassen, Ilona; Connett, Robyn; Worth, Tina; Vatine, Jean-Jacques; McCabe, Candida S

    2017-01-01

    Complex Regional Pain Syndrome (CRPS) is a persistent pain condition that remains incompletely understood and challenging to treat. Historically, a wide range of different outcome measures have been used to capture the multidimensional nature of CRPS. This has been a significant limiting factor in the advancement of our understanding of the mechanisms and management of CRPS. In 2013, an international consortium of patients, clinicians, researchers and industry representatives was established, to develop and agree on a minimum core set of standardised outcome measures for use in future CRPS clinical research, including but not limited to clinical trials within adult populations The development of a core measurement set was informed through workshops and supplementary work, using an iterative consensus process. ‘What is the clinical presentation and course of CRPS, and what factors influence it?’ was agreed as the most pertinent research question that our standardised set of patient-reported outcome measures should be selected to answer. The domains encompassing the key concepts necessary to answer the research question were agreed as: pain, disease severity, participation and physical function, emotional and psychological function, self efficacy, catastrophizing and patient's global impression of change. The final core measurement set included the optimum generic or condition-specific patient-reported questionnaire outcome measures, which captured the essence of each domain, and one clinician reported outcome measure to capture the degree of severity of CRPS. The next step is to test the feasibility and acceptability of collecting outcome measure data using the core measurement set in the CRPS population internationally. PMID:28178071

  8. Evaluation of outcome measures for use in clinical practice for adults with musculoskeletal conditions of the knee: a systematic review.

    Science.gov (United States)

    Howe, Tracey E; Dawson, Lesley J; Syme, Grant; Duncan, Louise; Reid, Judith

    2012-04-01

    This systematic review reported on the clinimetric properties of outcome measures for use in clinical practice for adults with musculoskeletal conditions of the knee. A systematic search was performed in Medline, EMBASE, Cinahl and AMED to identify studies examining the clinimetric properties of outcome measures for adults undergoing conservative treatment of ligament injuries, meniscal lesions, patellofemoral pain and osteoarthritis of the knee. Outcomes measures taking less than 20 min to administer and requiring minimal equipment and space were included. Pairs of authors used a checklist to record the characteristics of the outcome measures, their reported clinimetric properties and the demographics of the study populations. The OMERACT filters of 'truth' and 'discrimination' were applied to the data for each outcome measure by an expert panel. Forty-seven studies were included evaluating 37 outcome measures. Ten outcome measures had adequate supporting evidence for 'truth' and 'discrimination': AAOS, AKPS, goniometer measurement, IKDC, KOOS, LEFS, Lysholm, Tegner, WOMAC and WOMET. However none of the outcome measures had been comprehensively tested across all clinimetric properties. Despite the widespread use of some outcome measures in clinical practice and primary research, data on the clinimetric properties were available for only 37 and of these only 10 had adequate supporting evidence for use in this population. However, before a core set of outcome measures can be recommended use in clinical practice, for adults with musculoskeletal conditions of the knee, consensus should be obtained on 'feasibility' in terms of burden on the clinician and the participant. Copyright © 2011 Elsevier Ltd. All rights reserved.

  9. Fatigue is a reliable, sensitive and unique outcome measure in rheumatoid arthritis.

    LENUS (Irish Health Repository)

    Minnock, Patricia

    2009-12-01

    Fatigue is an important symptom in patients with RA. Measurement of fatigue in clinical trials and in clinical practice requires scales that are reproducible, sensitive to change and practical. This study examined the reliability and sensitivity to change of fatigue and its relative independence as an outcome measure in RA.

  10. AFRIMEDIC VOL. 1, NO. 2

    African Journals Online (AJOL)

    Buchi

    Background: Pre-labour rupture of membranes (PROM) at term is often encountered in current obstetric practice. Its management is sometimes controversial. Objectives: This was to determine the incidence, management modalities and pregnancy outcomes of cases of pre-labour rupture of membranes at term in Nnewi, ...

  11. Clinical Outcomes Measures for Assessment of Longevity in the Dental Implant Literature : ORONet Approach

    NARCIS (Netherlands)

    Bassi, Francesco; Carr, Alan B.; Chang, Ting-Ling; Estafanous, Emad; Garrett, Neal R.; Happonen, Risto-Pekka; Koka, Sreenivas; Laine, Juhani; Osswald, Martin; Reintsema, Harry; Rieger, Jana; Roumanas, Eleni; Salinas, Thomas J.; Stanford, Clark M.; Wolfaardt, Johan

    2013-01-01

    The Oral Rehabilitation Outcomes Network (ORONet) Longevity Working Group undertook a search of the literature from 1995 to 2009 on randomized controlled trials related to longevity of osseointegrated implants. Outcomes measures used in these studies were identified and subjected to the OMERACT

  12. Presurgery resting-state local graph-theory measures predict neurocognitive outcomes after brain surgery in temporal lobe epilepsy.

    Science.gov (United States)

    Doucet, Gaelle E; Rider, Robert; Taylor, Nathan; Skidmore, Christopher; Sharan, Ashwini; Sperling, Michael; Tracy, Joseph I

    2015-04-01

    This study determined the ability of resting-state functional connectivity (rsFC) graph-theory measures to predict neurocognitive status postsurgery in patients with temporal lobe epilepsy (TLE) who underwent anterior temporal lobectomy (ATL). A presurgical resting-state functional magnetic resonance imaging (fMRI) condition was collected in 16 left and 16 right TLE patients who underwent ATL. In addition, patients received neuropsychological testing pre- and postsurgery in verbal and nonverbal episodic memory, language, working memory, and attention domains. Regarding the functional data, we investigated three graph-theory properties (local efficiency, distance, and participation), measuring segregation, integration and centrality, respectively. These measures were only computed in regions of functional relevance to the ictal pathology, or the cognitive domain. Linear regression analyses were computed to predict the change in each neurocognitive domain. Our analyses revealed that cognitive outcome was successfully predicted with at least 68% of the variance explained in each model, for both TLE groups. The only model not significantly predictive involved nonverbal episodic memory outcome in right TLE. Measures involving the healthy hippocampus were the most common among the predictors, suggesting that enhanced integration of this structure with the rest of the brain may improve cognitive outcomes. Regardless of TLE group, left inferior frontal regions were the best predictors of language outcome. Working memory outcome was predicted mostly by right-sided regions, in both groups. Overall, the results indicated our integration measure was the most predictive of neurocognitive outcome. In contrast, our segregation measure was the least predictive. This study provides evidence that presurgery rsFC measures may help determine neurocognitive outcomes following ATL. The results have implications for refining our understanding of compensatory reorganization and predicting

  13. Expecting a good quality of life in health: assessing people with diverse diseases and conditions using the WHOQOL‐BREF

    Science.gov (United States)

    Skevington, Suzanne M.; McCrate, Farah M.

    2011-01-01

    Abstract Background and objectives  Fulfilling patient expectations is central to defining a good quality of life (QoL) in health. The WHOQOL‐BREF was developed using novel, person‐centred methods and is a generic patient‐reported outcomes measure (PROM). However, without robust psychometric performance, PROMs cannot be relied upon to assess individuals. This study investigated the WHOQOL‐BREF (UK), with this use in mind. Design  Cross sectional with nested repeated measures. Setting and participants  Twenty‐seven disease groups or health conditions and healthy people were recruited at 38 UK sites, in a wide range of settings (n = 4628). Interventions  ‘Treatment as usual’; new and alternative interventions. Outcome measures  WHOQOL‐BREF (UK); SF‐36. Results  Respondent burden was low, as acceptability and feasibility were high. Internal consistency was excellent (0.92) and test–retest reliability good. Distinctive QoL profiles were found for diverse conditions. Musculoskeletal, psychiatric and cardiovascular patients reported the poorest QoL and also improved most during treatment. Overall, QoL was good, and best for healthy groups, supporting discriminant validity. Compared with the SF‐36, WHOQOL physical and psychological domains showed good concurrent validity, although social was weak. Small or moderate effect sizes confirmed responsiveness to change in specified domains for certain conditions and interventions. Age had a small impact on reporting QoL. Discussion and conclusion  The WHOQOL‐BREF is found to be a high quality patient‐centred generic tool suited to individual assessment in clinics, for research, and audit. PMID:21281412

  14. Vision and vision-related outcome measures in multiple sclerosis

    DEFF Research Database (Denmark)

    Balcer, Laura J; Miller, David H; Reingold, Stephen C

    2015-01-01

    Visual impairment is a key manifestation of multiple sclerosis. Acute optic neuritis is a common, often presenting manifestation, but visual deficits and structural loss of retinal axonal and neuronal integrity can occur even without a history of optic neuritis. Interest in vision in multiple...... sclerosis is growing, partially in response to the development of sensitive visual function tests, structural markers such as optical coherence tomography and magnetic resonance imaging, and quality of life measures that give clinical meaning to the structure-function correlations that are unique...... of investigators involved in the development and study of visual outcomes in multiple sclerosis, which had, as its overriding goals, to review the state of the field and identify areas for future research. We review data and principles to help us understand the importance of vision as a model for outcomes...

  15. Initial constructs for patient-centered outcome measures to evaluate brain-computer interfaces.

    Science.gov (United States)

    Andresen, Elena M; Fried-Oken, Melanie; Peters, Betts; Patrick, Donald L

    2016-10-01

    The authors describe preliminary work toward the creation of patient-centered outcome (PCO) measures to evaluate brain-computer interface (BCI) as an assistive technology (AT) for individuals with severe speech and physical impairments (SSPI). In Phase 1, 591 items from 15 existing measures were mapped to the International Classification of Functioning, Disability and Health (ICF). In Phase 2, qualitative interviews were conducted with eight people with SSPI and seven caregivers. Resulting text data were coded in an iterative analysis. Most items (79%) were mapped to the ICF environmental domain; over half (53%) were mapped to more than one domain. The ICF framework was well suited for mapping items related to body functions and structures, but less so for items in other areas, including personal factors. Two constructs emerged from qualitative data: quality of life (QOL) and AT. Component domains and themes were identified for each. Preliminary constructs, domains and themes were generated for future PCO measures relevant to BCI. Existing instruments are sufficient for initial items but do not adequately match the values of people with SSPI and their caregivers. Field methods for interviewing people with SSPI were successful, and support the inclusion of these individuals in PCO research. Implications for Rehabilitation Adapted interview methods allow people with severe speech and physical impairments to participate in patient-centered outcomes research. Patient-centered outcome measures are needed to evaluate the clinical implementation of brain-computer interface as an assistive technology.

  16. Faustmann and the forestry tradition of outcome-based performance measures

    Science.gov (United States)

    Peter J. Ince

    1999-01-01

    The concept of land expectation value developed by Martin Faustmann may serve as a paradigm for outcome-based performance measures in public forest management if the concept of forest equity value is broadened to include social and environmental benefits and costs, and sustainability. However, anticipation and accurate evaluation of all benefits and costs appears to...

  17. Systematic review of tools to measure outcomes for young children with autism spectrum disorder

    NARCIS (Netherlands)

    McConachie, H.; Parr, J.R.; Glod, M.; Hanratty, J.; Livingstone, N.; Oono, I.P.; Robalino, S.; Baird, G.; Beresford, B.; Charman, T.; Garland, D.; Green, J.; Gringras, P.; Jones, G.; Law, J.; Le Couteur, A.S.; Macdonald, G.; McColl, E.M.; Morris, C.; Rodgers, J.; Simonoff, E.; Terwee, C.B.; Williams, K.

    2015-01-01

    Background: The needs of children with autism spectrum disorder (ASD) are complex and this is reflected in the number and diversity of outcomes assessed and measurement tools used to collect evidence about children�s progress. Relevant outcomes include improvement in core ASD impairments, such as

  18. Developing a General Outcome Measure of Growth in Movement for Infants and Toddlers.

    Science.gov (United States)

    Greenwood, Charles R.; Luze, Gayle J.; Cline, Gabriel; Kuntz, Susan; Leitschuh, Carol

    2002-01-01

    The development of an experimental measure for assessing growth in movement in children (ages birth-3) is described. Results from the use of the Movement General Outcome Measurement with 29 infants and toddlers demonstrated the feasibility of the measure. The 6-minute assessment was found reliable in terms of inter-observer agreement. (Contains…

  19. Comparison of umbilical cord interleukin-6 in preterm infants with premature rupture of membranes and intact membranes

    International Nuclear Information System (INIS)

    Gharebaghi, Manizheh M.; Peirovifar, A.; Gharebaghi, Parvin M.

    2008-01-01

    Objective was to compare inflammatory mediators in the cord blood of premature newborn infants with premature rupture of membranes (PROM) and intact membranes. Eighty-nine premature neonates with gestational age of 27-34 weeks that delivered in Ghaem Hospital in Mashhad, Iran from June 2005 to March 2006 were enrolled in a prospective observational study and their umbilical cord plasma was collected at birth. They were allocated into 2 groups (45 patients with PROM and 44 neonates with intact membranes). Interleukin-6 (IL-6) and C-reactive protein (CRP) levels were measured in cord plasma by the enzyme linked immunoassay (ELISA) method. Mean cord plasma IL-6 levels in preterm neonates with PROM was 205.71 pg/ml and in neonates with intact membranes was 33.3 pg/ml for IL-6 (p=0.000). The mean cord blood CRP level in newborns was 10.2 ug/ml, and in those with intact membranes was 1.6 ug/ml and in those with intact membranes was 1.6 ug/ml (p=0.41). Early onset sepsis was more frequent in infants with PROM than premature infants with intact membrane (38% versus 10%, p=0.001). In neonates with PROM, the mean cord blood IL-6 level was significantly higher in septic newborns (414.28 versus 40.44 pg/ml, p=0.000). The premature newborn infants with PROM had increased IL-6 levels in cord blood, which was significantly higher in neonates that developed early onset sepsis. (author)

  20. Can community change be measured for an outcomes-based initiative? A comparative case study of the success by 6 initiative.

    Science.gov (United States)

    Minich, Lisa; Howe, Steven; Langmeyer, Daniel; Corcoran, Kevin

    2006-12-01

    One of the challenges facing nonprofit organizations today is the demand for measurable results. Increasingly, these organizations are focusing less on program outputs and program outcomes in favor of community outcomes or changes demonstrated in the larger community. Success by 6(R) is a popular United Way initiative that emphasizes defining and measuring community outcomes. In this paper, we describe our work with 24 Success by 6(R) initiatives around the country. It is clear that not all of these initiatives are measuring community outcomes. Of those initiatives that are experiencing some success measuring community outcomes, similar measurement strategies are reported. Additionally, our experience suggests several United Way employees express dissatisfaction with the logic model as a framework for defining and measuring community outcomes although no preferred alternative model is identified. Evaluators working with community-wide initiatives must find ways to communicate the differences between program and community outcomes to key stakeholders and funders.

  1. Discrepancies between patient-reported outcome measures when assessing urinary incontinence or pelvic-prolapse surgery

    DEFF Research Database (Denmark)

    Larsen, Michael Due; Lose, Gunnar; Guldberg, Rikke

    2016-01-01

    INTRODUCTION AND HYPOTHESIS: In order to assess the outcome following surgery for urinary incontinence (UI) and pelvic organ prolapse (POP) the importance of patient-reported outcome measures, in addition to the clinical objective measures, has been recognised. The International Consultation...... on Incontinence has initiated the development and evaluation of disease-specific questionnaires (ICIQ) to compare the patient's degree of improvement. Alternatively, the Patient's Global Impression of Improvement (PGI-I score) with an inherent before-after assessment has been widely accepted in recent studies...

  2. An International Standard Set of Patient-Centered Outcome Measures After Stroke

    NARCIS (Netherlands)

    Salinas, J. (Joel); Sprinkhuizen, S.M. (Sara M.); Ackerson, T. (Teri); Bernhardt, J. (Julie); Davie, C. (Charlie); George, M.G. (Mary G.); Gething, S. (Stephanie); Kelly, A.G. (Adam G.); Lindsay, P. (Patrice); Liu, L. (Liping); Martins, S.C.O. (Sheila C.O.); Morgan, L. (Louise); B. Norrving (Bo); Ribbers, G.M. (Gerard M.); Silver, F.L. (Frank L.); Smith, E.E. (Eric E.); Williams, L.S. (Linda S.); Schwamm, L.H. (Lee H.)

    2015-01-01

    markdownabstract__BACKGROUND AND PURPOSE:__ Value-based health care aims to bring together patients and health systems to maximize the ratio of quality over cost. To enable assessment of healthcare value in stroke management, an international standard set of patient-centered stroke outcome measures

  3. Relationship of patient-reported outcomes with MRI measures in rheumatoid arthritis

    DEFF Research Database (Denmark)

    Baker, Joshua F; Conaghan, Philip G.; Emery, Paul

    2017-01-01

    PURPOSE: We assessed whether MRI measures of synovitis, osteitis and bone erosion were associated with patient-reported outcomes (PROs) in a longitudinal clinical trial setting among patients with rheumatoid arthritis (RA). METHODS: This longitudinal cohort of 291 patients with RA was derived from...

  4. Considerations for analysis of time-to-event outcomes measured with error: Bias and correction with SIMEX.

    Science.gov (United States)

    Oh, Eric J; Shepherd, Bryan E; Lumley, Thomas; Shaw, Pamela A

    2018-04-15

    For time-to-event outcomes, a rich literature exists on the bias introduced by covariate measurement error in regression models, such as the Cox model, and methods of analysis to address this bias. By comparison, less attention has been given to understanding the impact or addressing errors in the failure time outcome. For many diseases, the timing of an event of interest (such as progression-free survival or time to AIDS progression) can be difficult to assess or reliant on self-report and therefore prone to measurement error. For linear models, it is well known that random errors in the outcome variable do not bias regression estimates. With nonlinear models, however, even random error or misclassification can introduce bias into estimated parameters. We compare the performance of 2 common regression models, the Cox and Weibull models, in the setting of measurement error in the failure time outcome. We introduce an extension of the SIMEX method to correct for bias in hazard ratio estimates from the Cox model and discuss other analysis options to address measurement error in the response. A formula to estimate the bias induced into the hazard ratio by classical measurement error in the event time for a log-linear survival model is presented. Detailed numerical studies are presented to examine the performance of the proposed SIMEX method under varying levels and parametric forms of the error in the outcome. We further illustrate the method with observational data on HIV outcomes from the Vanderbilt Comprehensive Care Clinic. Copyright © 2017 John Wiley & Sons, Ltd.

  5. A critical appraisal of instruments to measure outcomes of interprofessional education.

    Science.gov (United States)

    Oates, Matthew; Davidson, Megan

    2015-04-01

    Interprofessional education (IPE) is believed to prepare health professional graduates for successful collaborative practice. A range of instruments have been developed to measure the outcomes of IPE. An understanding of the psychometric properties of these instruments is important if they are to be used to measure the effectiveness of IPE. This review set out to identify instruments available to measure outcomes of IPE and collaborative practice in pre-qualification health professional students and to critically appraise the psychometric properties of validity, responsiveness and reliability against contemporary standards for instrument design. Instruments were selected from a pool of extant instruments and subjected to critical appraisal to determine whether they satisfied inclusion criteria. The qualitative and psychometric attributes of the included instruments were appraised using a checklist developed for this review. Nine instruments were critically appraised, including the widely adopted Readiness for Interprofessional Learning Scale (RIPLS) and the Interdisciplinary Education Perception Scale (IEPS). Validity evidence for instruments was predominantly based on test content and internal structure. Ceiling effects and lack of scale width contribute to the inability of some instruments to detect change in variables of interest. Limited reliability data were reported for two instruments. Scale development and scoring protocols were generally reported by instrument developers, but the inconsistent application of scoring protocols for some instruments was apparent. A number of instruments have been developed to measure outcomes of IPE in pre-qualification health professional students. Based on reported validity evidence and reliability data, the psychometric integrity of these instruments is limited. The theoretical test construction paradigm on which instruments have been developed may be contributing to the failure of some instruments to detect change in

  6. Use of and confidence in administering outcome measures among clinical prosthetists: Results from a national survey and mixed-methods training program.

    Science.gov (United States)

    Gaunaurd, Ignacio; Spaulding, Susan E; Amtmann, Dagmar; Salem, Rana; Gailey, Robert; Morgan, Sara J; Hafner, Brian J

    2015-08-01

    Outcome measures can be used in prosthetic practices to evaluate interventions, inform decision making, monitor progress, document outcomes, and justify services. Strategies to enhance prosthetists' ability to use outcome measures are needed to facilitate their adoption in routine practice. To assess prosthetists' use of outcome measures and evaluate the effects of training on their confidence in administering performance-based measures. Cross-sectional and single-group pretest-posttest survey. Seventy-nine certified prosthetists (mean of 16.0 years of clinical experience) were surveyed about their experiences with 20 standardized outcome measures. Prosthetists were formally trained by the investigators to administer the Timed Up and Go and Amputee Mobility Predictor. Prosthetists' confidence in administering the Timed Up and Go and Amputee Mobility Predictor was measured before and after training. The majority of prosthetists (62%) were classified as non-routine outcome measure users. Confidence administering the Timed Up and Go and Amputee Mobility Predictor prior to training was low-to-moderate across the study sample. Training significantly (p measures. Interactive training resulted in a statistically significant increase of prosthetists' confidence in administering the Timed Up and Go and Amputee Mobility Predictor and may facilitate use of outcome measures in clinical practice. Frequency of outcome measure use in the care of persons with limb loss has not been studied. Study results suggest that prosthetists may not regularly use standardized outcome measures and report limited confidence in administering them. Training enhances confidence and may encourage use of outcome measures in clinical practice. © The International Society for Prosthetics and Orthotics 2014.

  7. Birth outcome measures and prenatal exposure to 4-tert-octylphenol

    International Nuclear Information System (INIS)

    Lv, Shenliang; Wu, Chunhua; Lu, Dasheng; Qi, Xiaojuan; Xu, Hao; Guo, Jianqiu; Liang, Weijiu; Chang, XiuLi

    2016-01-01

    Exposure to 4-tert-octylphenol (tOP) has been linked with adverse health outcomes in animals and humans, while epidemiological studies about associations between prenatal exposure to tOP and fetal growth are extremely limited. We measured urinary tOP concentrations in 1100 pregnant women before their delivery, and examined whether tOP levels were associated with birth outcomes, including weight, length, head circumference and ponderal index at birth. tOP could be detected in all samples, and the median uncorrected and creatinine-corrected tOP concentrations were 0.90 μg/L (range from 0.25 to 20.05 μg/L) and 1.33 μg/g creatinine (range from 0.15 to 42.49 μg/g creatinine), respectively. Maternal urinary log-transformed tOP concentrations were significantly negatively associated with adjusted birth weight [β (g) = −126; 95% confidence interval (CI): −197, −55], birth length [β (cm) = −0.53; 95% CI:−0.93, −0.14], and head circumference [β (cm) = −0.30; 95% CI: −0.54, −0.07], respectively. Additionally, considering sex difference, these significant negative associations were also found among male neonates, while only higher maternal tOP concentrations were associated with a significant decrease in birth weight among female neonates. This study suggested significant negative associations between maternal urinary tOP concentrations and neonatal sizes at birth, and they differed by neonatal sex. Further epidemiological studies are required to more fully elaborate the associations between prenatal tOP exposure and birth outcomes. - Highlights: • We measured 4-tert-octylphenol (tOP) in urine from 1100 Chinese pregnant women. • The associations between maternal tOP levels and birth outcomes were investigated. • Prenatal exposure to tOP in the selected area was widespread at higher levels. • Maternal tOP levels were significantly negatively associated with birth sizes. • The associations between tOP and birth outcomes might

  8. Single-case synthesis tools II: Comparing quantitative outcome measures.

    Science.gov (United States)

    Zimmerman, Kathleen N; Pustejovsky, James E; Ledford, Jennifer R; Barton, Erin E; Severini, Katherine E; Lloyd, Blair P

    2018-03-07

    Varying methods for evaluating the outcomes of single case research designs (SCD) are currently used in reviews and meta-analyses of interventions. Quantitative effect size measures are often presented alongside visual analysis conclusions. Six measures across two classes-overlap measures (percentage non-overlapping data, improvement rate difference, and Tau) and parametric within-case effect sizes (standardized mean difference and log response ratio [increasing and decreasing])-were compared to determine if choice of synthesis method within and across classes impacts conclusions regarding effectiveness. The effectiveness of sensory-based interventions (SBI), a commonly used class of treatments for young children, was evaluated. Separately from evaluations of rigor and quality, authors evaluated behavior change between baseline and SBI conditions. SBI were unlikely to result in positive behavior change across all measures except IRD. However, subgroup analyses resulted in variable conclusions, indicating that the choice of measures for SCD meta-analyses can impact conclusions. Suggestions for using the log response ratio in SCD meta-analyses and considerations for understanding variability in SCD meta-analysis conclusions are discussed. Copyright © 2018 Elsevier Ltd. All rights reserved.

  9. Effect of Ankle Range of Motion (ROM) and Lower-Extremity Muscle Strength on Static Balance Control Ability in Young Adults: A Regression Analysis.

    Science.gov (United States)

    Kim, Seong-Gil; Kim, Wan-Soo

    2018-05-15

    BACKGROUND The purpose of this study was to investigate the effect of ankle ROM and lower-extremity muscle strength on static balance control ability in young adults. MATERIAL AND METHODS This study was conducted with 65 young adults, but 10 young adults dropped out during the measurement, so 55 young adults (male: 19, female: 36) completed the study. Postural sway (length and velocity) was measured with eyes open and closed, and ankle ROM (AROM and PROM of dorsiflexion and plantarflexion) and lower-extremity muscle strength (flexor and extensor of hip, knee, and ankle joint) were measured. Pearson correlation coefficient was used to examine the correlation between variables and static balance ability. Simple linear regression analysis and multiple linear regression analysis were used to examine the effect of variables on static balance ability. RESULTS In correlation analysis, plantarflexion ROM (AROM and PROM) and lower-extremity muscle strength (except hip extensor) were significantly correlated with postural sway (psimple correlation analysis, all variables that passed the correlation analysis procedure had significant influence (plinear regression analysis, plantar flexion PROM with eyes open significantly influenced sway length (B=0.681) and sway velocity (B=0.011). CONCLUSIONS Lower-extremity muscle strength and ankle plantarflexion ROM influenced static balance control ability, with ankle plantarflexion PROM showing the greatest influence. Therefore, both contractile structures and non-contractile structures should be of interest when considering static balance control ability improvement.

  10. Relationships between Student, Staff, and Administrative Measures of School Climate and Student Health and Academic Outcomes

    Science.gov (United States)

    Gase, Lauren Nichol; Gomez, Louis M.; Kuo, Tony; Glenn, Beth A.; Inkelas, Moira; Ponce, Ninez A.

    2018-01-01

    BACKGROUND School climate is an integral part of a comprehensive approach to improving the wellbeing of students; however, little is known about the relationships between its different domains and measures. This study examined the relationships between student, staff, and administrative measures of school climate in order to understand the extent to which they were related to each other and student outcomes. METHODS The sample included 33,572 secondary school students from 121 schools in Los Angeles County during the 2014–2015 academic year. A multilevel regression model was constructed to examine the association between the domains and measures of school climate and five outcomes of student wellbeing: depressive symptoms or suicidal ideation, tobacco use, alcohol use, marijuana use, and grades. RESULTS Student, staff, and administrative measures of school climate were weakly correlated. Strong associations were found between student outcomes and student reports of engagement and safety, while school staff reports and administrative measures of school climate showed limited associations with student outcomes. CONCLUSIONS As schools seek to measure and implement interventions aimed at improving school climate, consideration should be given to grounding these efforts in a multi-dimensional conceptualization of climate that values student perspectives and includes elements of both engagement and safety. PMID:28382671

  11. Relationships Among Student, Staff, and Administrative Measures of School Climate and Student Health and Academic Outcomes.

    Science.gov (United States)

    Gase, Lauren N; Gomez, Louis M; Kuo, Tony; Glenn, Beth A; Inkelas, Moira; Ponce, Ninez A

    2017-05-01

    School climate is an integral part of a comprehensive approach to improving the well-being of students; however, little is known about the relationships between its different domains and measures. We examined the relationships between student, staff, and administrative measures of school climate to understand the extent to which they were related to each other and student outcomes. The sample included 33,572 secondary school students from 121 schools in Los Angeles County during the 2014-2015 academic year. A multilevel regression model was constructed to examine the association between the domains and measures of school climate and 5 outcomes of student well-being: depressive symptoms or suicidal ideation, tobacco use, alcohol use, marijuana use, and grades. Student, staff, and administrative measures of school climate were weakly correlated. Strong associations were found between student outcomes and student reports of engagement and safety, while school staff reports and administrative measures of school climate showed limited associations with student outcomes. As schools seek to measure and implement interventions aimed at improving school climate, consideration should be given to grounding these efforts in a multidimensional conceptualization of climate that values student perspectives and includes elements of both engagement and safety. © 2017, American School Health Association.

  12. Comparing oncoplastic breast conserving surgery with mastectomy and immediate breast reconstruction: Case-matched patient reported outcomes.

    Science.gov (United States)

    Kelsall, Jennett E; McCulley, Stephen J; Brock, Lisa; Akerlund, Malin T E; Macmillan, R Douglas

    2017-10-01

    Oncoplastic breast conserving surgery (OBCS) allows women who may otherwise have mastectomy and immediate reconstruction (MxIR) the choice to conserve their breast yet avoid deformity. We compared the outcome of these options. Two cohorts meeting study criteria were identified from prospectively audited series of women undergoing OBCS or MxIR. After case matching for age, tumour size and date of surgery, stratification by breast size and controlling for radiotherapy; body image scale (BIS) scores of psychosocial function and patient reported outcome measures (PROMs) for breast appearance and return to function were analysed. A total of 567 women (286 treated by OBCS and 281 by MxIR) fulfilled inclusion criteria. Demographics were similar between the two unmatched cohorts, except for radiotherapy, age and tumour size (all p < 0.001). Overall, BIS score (p = 0.002), self-rated breast appearance, return to work and function (all p < 0.001) significantly favoured OBCS. Case-matched women with larger breasts treated by OBCS reported better BIS scores (mean 3.30 vs. 5.37, p = 0.011) and self-rated breast appearance score (p < 0.001) than MxIR, whereas no significant difference was observed for smaller breasts. BIS and appearance favoured OBCS, regardless of whether radiotherapy would have been avoided if treated by MxIR. OBCS offers suitable women the option to avoid MxIR while providing faster recovery. Better psychosocial and self-rated satisfaction with breast appearance is achieved for OBCS in all groups, regardless of the need for radiotherapy, apart from those women with smaller breasts for whom the results are comparable. Copyright © 2017 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

  13. Factors affecting planned return to work after trauma: A prospective descriptive qualitative and quantitative study.

    Science.gov (United States)

    Folkard, S S; Bloomfield, T D; Page, P R J; Wilson, D; Ricketts, D M; Rogers, B A

    2016-12-01

    The use of patient reported outcome measures (PROMs) in trauma is limited. The aim of this pilot study is to evaluate qualitative responses and factors affecting planned return to work following significant trauma, for which there is currently a poor evidence base. National ethical approval was obtained for routine prospective PROMs data collection, including EQ-5D, between Sept 2013 and March 2015 for trauma patients admitted to the Sussex Major Trauma Centre (n=92). 84 trauma patients disclosed their intended return to work at discharge. Additional open questions asked 'things done well' and 'things to be improved'. EQ-5D responses were valued using the time trade-off method. Statistical analysis between multiple variables was completed by ANOVA, and with categorical categories by Chi squared analysis. Only 18/68 of patients working at admission anticipated returning to work within 14days post-discharge. The injury severity scores (ISS) of those predicting return to work within two weeks and those predicting return to work longer than two weeks were 14.17 and 13.59, respectively. Increased physicality of work showed a trend towards poorer return to work outcomes, although non-significant in Chi-squared test in groups predicting return in less than or greater than two weeks (4.621, p=0.2017ns). No significant difference was demonstrated in the comparative incomes of patients with different estimated return to work outcomes (ANOVA r 2 =0.001, P=0.9590ns). EQ-5D scores were higher in those predicting return to work within two weeks when compared to greater than two weeks. Qualitative thematic content analysis of open responses was possible for 66/92 of respondents. Prominent positive themes were: care, staff, professionalism, and communication. Prominent negative themes were: food, ward response time, and communication. This pilot study highlights the importance of qualitative PROMs analysis in leading patient-driven improvements in trauma care. We provide standard

  14. Test-Retest Reliability of Dual-Task Outcome Measures in People With Parkinson Disease

    NARCIS (Netherlands)

    Strouwen, C.; Molenaar, E.A.; Keus, S.H.; Munks, L.; Bloem, B.R.; Nieuwboer, A.

    2016-01-01

    BACKGROUND: Dual-task (DT) training is gaining ground as a physical therapy intervention in people with Parkinson disease (PD). Future studies evaluating the effect of such interventions need reliable outcome measures. To date, the test-retest reliability of DT measures in patients with PD remains

  15. Health economics research into supporting carers of people with dementia: A systematic review of outcome measures

    Science.gov (United States)

    2012-01-01

    Advisory bodies, such as the National Institute for Health and Clinical Excellence (NICE) in the UK, advocate using preference based instruments to measure the quality of life (QoL) component of the quality-adjusted life year (QALY). Cost per QALY is used to determine cost-effectiveness, and hence funding, of interventions. QALYs allow policy makers to compare the effects of different interventions across different patient groups. Generic measures may not be sensitive enough to fully capture the QoL effects for certain populations, such as carers, so there is a need to consider additional outcome measures, which are preference based where possible to enable cost-effectiveness analysis to be undertaken. This paper reviews outcome measures commonly used in health services research and health economics research involving carers of people with dementia. An electronic database search was conducted in PubMed, Medline, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, the National Health Service Economic Evaluation Database (NHS EED), Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment database. Studies were eligible for inclusion if they included an outcome measure for carers of people with dementia. 2262 articles were identified. 455 articles describing 361 studies remained after exclusion criteria were applied. 228 outcome measures were extracted from the studies. Measures were categorised into 44 burden measures, 43 mastery measures, 61 mood measures, 32 QoL measures, 27 social support and relationships measures and 21 staff competency and morale measures. The choice of instrument has implications on funding decisions; therefore, researchers need to choose appropriate instruments for the population being measured and the type of intervention undertaken. If an instrument is not sensitive enough to detect changes in certain populations, the effect of an intervention may be underestimated, and hence

  16. The Oxford Participation and Activities Questionnaire: study protocol

    Directory of Open Access Journals (Sweden)

    Morley D

    2013-12-01

    Full Text Available David Morley, Sarah Dummett, Laura Kelly, Jill Dawson, Ray Fitzpatrick, Crispin JenkinsonNuffield Department of Population Health, University of Oxford, Oxford, UKBackground: With an ageing population and increasing demands on health and social care services, there is growing importance attached to the management of long-term conditions, including maximizing the cost-effectiveness of treatments. In line with this, there is increasing emphasis on the need to keep people both active and participating in daily life. Consequently, it is essential that well developed and validated instruments that can meaningfully assess levels of participation and activity are widely available. Current measures, however, are largely focused on disability and rehabilitation, and there is no measure of activity or participation for generic use that fully meets the standards set by regulatory bodies such as the US Food and Drug Administration. Here we detail a protocol for the development and validation of a new patient-reported outcome measure (PROM for assessment of participation and activity in people experiencing a variety of health conditions, ie, the Oxford Participation and Activities Questionnaire (Ox-PAQ. The stages incorporated in its development are entirely in line with current regulations and represent best practice in the development of PROMs.Methods: Development of the Ox-PAQ is theoretically grounded in the World Health Organization International Classification of Functioning, Disability, and Health. The project incorporates a new strategy of engaging with stakeholders from the outset in an attempt to identify those characteristics of PROMs considered most important to a range of potential users. Items will be generated through interviews with patients from a range of conditions. Pretesting of the instrument will be via cognitive interviews and focus groups. A postal survey will be conducted, with data subject to factor and Rasch analysis in order to

  17. PROMIS GH (Patient-Reported Outcomes Measurement Information System Global Health) Scale in Stroke: A Validation Study.

    Science.gov (United States)

    Katzan, Irene L; Lapin, Brittany

    2018-01-01

    The International Consortium for Health Outcomes Measurement recently included the 10-item PROMIS GH (Patient-Reported Outcomes Measurement Information System Global Health) scale as part of their recommended Standard Set of Stroke Outcome Measures. Before collection of PROMIS GH is broadly implemented, it is necessary to assess its performance in the stroke population. The objective of this study was to evaluate the psychometric properties of PROMIS GH in patients with ischemic stroke and intracerebral hemorrhage. PROMIS GH and 6 PROMIS domain scales measuring same/similar constructs were electronically collected on 1102 patients with ischemic and hemorrhagic strokes at various stages of recovery from their stroke who were seen in a cerebrovascular clinic from October 12, 2015, through June 2, 2017. Confirmatory factor analysis was performed to evaluate the adequacy of 2-factor structure of component scores. Test-retest reliability and convergent validity of PROMIS GH items and component scores were assessed. Discriminant validity and responsiveness were compared between PROMIS GH and PROMIS domain scales measuring the same or related constructs. Analyses were repeated stratified by stroke subtype and modified Rankin Scale score validity was good with significant correlations between all PROMIS GH items and PROMIS domain scales ( P 0.5) was demonstrated for 8 of the 10 PROMIS GH items. Reliability and validity remained consistent across stroke subtype and disability level (modified Rankin Scale, <2 versus ≥2). PROMIS GH exhibits acceptable performance in patients with stroke. Our findings support International Consortium for Health Outcomes Measurement recommendation to use PROMIS GH as part of the standard set of outcome measures in stroke. © 2017 American Heart Association, Inc.

  18. Report from the third international consensus meeting to harmonise core outcome measures for atopic eczema/dermatitis clinical trials (HOME)

    Science.gov (United States)

    Chalmers, JR; Schmitt, J; Apfelbacher, C; Dohil, M; Eichenfield, LF; Simpson, EL; Singh, J; Spuls, P; Thomas, KS; Admani, S; Aoki, V; Ardeleanu, M; Barbarot, S; Berger, T; Bergman, JN; Block, J; Borok, N; Burton, T; Chamlin, SL; Deckert, S; DeKlotz, CC; Graff, LB; Hanifin, JM; Hebert, AA; Humphreys, R; Katoh, N; Kisa, RM; Margolis, DJ; Merhand, S; Minnillo, R; Mizutani, H; Nankervis, H; Ohya, Y; Rodgers, P; Schram, ME; Stalder, JF; Svensson, A; Takaoka, R; Teper, A; Tom, WL; von Kobyletzki, L; Weisshaar, E; Zelt, S; Williams, HC

    2014-01-01

    Summary This report provides a summary of the third meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in San Diego, CA, U.S.A., 6–7 April 2013 (HOME III). The meeting addressed the four domains that had previously been agreed should be measured in every eczema clinical trial: clinical signs, patient-reported symptoms, long-term control and quality of life. Formal presentations and nominal group techniques were used at this working meeting, attended by 56 voting participants (31 of whom were dermatologists). Significant progress was made on the domain of clinical signs. Without reference to any named scales, it was agreed that the intensity and extent of erythema, excoriation, oedema/papulation and lichenification should be included in the core outcome measure for the scale to have content validity. The group then discussed a systematic review of all scales measuring the clinical signs of eczema and their measurement properties, followed by a consensus vote on which scale to recommend for inclusion in the core outcome set. Research into the remaining three domains was presented, followed by discussions. The symptoms group and quality of life groups need to systematically identify all available tools and rate the quality of the tools. A definition of long-term control is needed before progress can be made towards recommending a core outcome measure. What's already known about this topic? Many different scales have been used to measure eczema, making it difficult to compare trials in meta-analyses and hampering improvements in clinical practice. HOME core outcome measures must pass the OMERACT (Outcome Measures in Rheumatology) filter of truth (validity), discrimination (sensitivity to change and responsiveness) and feasibility (ease of use, costs, time to perform and interpret). It has been previously agreed as part of the consensus process that four domains should be measured by the core outcomes: clinical signs, patient

  19. Measuring Learning Outcomes. Evolution of Cognitive Skills among Graduate Students in Auditing

    DEFF Research Database (Denmark)

    Holm, Claus; Steenholdt, Niels

    with the knowledge provided in a graduate course the student learns from his prior experiences and stores the important aspects of each experience in memory in accordance with such schemas. The schemas available for students taking a graduate auditing course reflects prior accounting work experience for some...... students and undergraduate accounting coursework experience for all students. This paper extends prior research on the role of declarative and procedural knowledge in performing auditing tasks. Measuring learning outcomes is a complex matter requiring sensible measures for both declarative knowledge...... outcomes in the context of an auditing course by posing a broad set of questions testing declarative knowledge and the full range of intellectual skills from discrimination to the use of higher-order-rules . The paper presents data collected in September 1999 including 34 graduate students representing...

  20. Historical perspective: The pros and cons of conventional outcome measures in Parkinson's disease.

    Science.gov (United States)

    Lim, Shen-Yang; Tan, Ai Huey

    2018-01-01

    Conventional outcome measures (COMs) in Parkinson's disease (PD) refer to rating scales, questionnaires, patient diaries and clinically-based tests that do not require specialized equipment. It is timely at this juncture - as clinicians and researchers begin to grapple with the "invasion" of digital technologies - to review the strengths and weaknesses of these outcome measures. This paper discusses advances (including an enhanced understanding of PD itself, and the development of clinimetrics as a field) that have led to improvements in the COMs used in PD; their strengths and limitations; and factors to consider when selecting and using a measuring instrument. It is envisaged that in the future, a combination of COMs and technology-based objective measures will be utilized, with different methods having their own strengths and weaknesses. Judgement is required on the part of the clinician and researcher in terms of which instrument(s) are appropriate to use, depending on the particular clinical or research setting or question. Copyright © 2017 Elsevier Ltd. All rights reserved.

  1. Outcome measures for oral health based on clinical assessments and claims data: feasibility evaluation in practice.

    Science.gov (United States)

    Hummel, Riët; Bruers, Josef; van der Galiën, Onno; van der Sanden, Wil; van der Heijden, Geert

    2017-10-05

    It is well known that treatment variation exists in oral healthcare, but the consequences for oral health are unknown as the development of outcome measures is still in its infancy. The aim of this study was to identify and develop outcome measures for oral health and explore their performance using health insurance claims records and clinical data from general dental practices. The Dutch healthcare insurance company Achmea collaborated with researchers, oral health experts, and general dental practitioners (GDPs) in a proof of practice study to test the feasibility of measures in general dental practices. A literature search identified previously described outcome measures for oral healthcare. Using a structured approach, identified measures were (i) prioritized, adjusted and added to after discussion and then (ii) tested for feasibility of data collection, their face validity and discriminative validity. Data sources were claims records from Achmea, clinical records from dental practices, and prospective, pre-determined clinical assessment data obtained during routine consultations. In total eight measures (four on dental caries, one on tooth wear, two on periodontal health, one on retreatment) were identified, prioritized and tested. The retreatment measure and three measures for dental caries were found promising as data collection was feasible, they had face validity and discriminative validity. Deployment of these measures demonstrated variation in clinical practices of GDPs. Feedback of this data to GDPs led to vivid discussions on best practices and quality of care. The measure 'tooth wear' was not considered sufficiently responsive; 'changes in periodontal health score' was considered a controversial measure. The available data for the measures 'percentage of 18-year-olds with no tooth decay' and 'improvement in gingival bleeding index at reassessment' was too limited to provide accurate estimates per dental practice. The evaluated measures 'time to first

  2. Questioning the Use of Outcome Measures to Evaluate Principal Preparation Programs

    Science.gov (United States)

    Fuller, Ed; Hollingworth, Liz

    2018-01-01

    Policymakers are proposing the use of outcome measures as indicators of effective principal preparation programs. The three most common metrics recommended are: (1) graduates' effectiveness in improving student achievement test scores, (2) graduate job placement rates, and (3) principal job retention once employed. This article explores the use of…

  3. Reliability and validity study on the Hungarian versions of the oswestry disability index and the Quebec back pain disability scale.

    Science.gov (United States)

    Valasek, Tamás; Varga, Peter Paul; Szövérfi, Zsolt; Kümin, Michelle; Fairbank, Jeremy; Lazary, Aron

    2013-05-01

    Patient-reported outcome measurements (PROMs) are widely used in spine care. The development of reliable and valid National versions of spine-related disability questionnaires is strongly recommended from both the clinical and scientific points-of-view. The aims of this study were to adapt and validate the Oswestry Disability Index (ODI) and the Quebec back pain disability scale (QDS) for use with the Hungarian language. After translating and culturally adapting the ODI and QDS, 133 patients with lumbar degenerative spinal disorder filled in the questionnaire booklet twice within 2 weeks. Subjects completed the Hungarian versions of the two PROMs as well as the WHOQoL-BREF validated as a general life quality questionnaire and Visual Analogue Scale of pain. Internal consistency, reliability and construct validity of the questionnaires were determined, as were the standard error of measurement (SEM) and minimal detectable change (MDC) scores. The Hungarian ODI consisted of one factor that showed good internal consistency (Cronbach-α 0.890). The QDS showed a four-factor structure with Cronbach-α values between 0.788 and 0.917. No significant floor or ceiling effects were observed. The test-retest analysis showed excellent reliability of the Hungarian ODI and QDS. The intraclass correlation coefficients (ICC) were 0.927 and 0.923, respectively. SEM values of 4.8 and 5.2 resulted in a MDC of 13 and 14 points in the Hungarian ODI and QDS, respectively. The correlation coefficient (r) between pain and ODI was 0.680 (p 0.4, p disability measured by the Hungarian ODI and QDS was significantly higher in the surgical subgroup than in non-surgically treated patients (p < 0.001). Translation and cultural adaptation of the ODI and QDS were successful. Hungarian versions of the ODI and QDS proved to be reliable, valid PROMs confirming that they can be used in future clinical and scientific work with Hungarian-speaking spine patients.

  4. Measuring outcomes of communication partner training of health care professionals:

    DEFF Research Database (Denmark)

    Isaksen, Jytte; Jensen, Lise Randrup

    health care, and other communicative exchanges associated with appropriate health care [3]. As a consequence of these challenges in patient-provider communication, implementation of evidence- based methods of communication partner training is becoming increasingly frequent in different health care...... with large groups of trainees, e.g. all staff from a ward. Self-rating questionnaires, however, present another set of issues when used as outcome measures, including the need to examine their content validity, reliability and sensitivity to change [9]. This work appears to be lacking for most...... of the available questionnaires. However, it is important in order to lay the groundwork for future studies, which compare the efficacy and outcome of different methods of implementing conversation partner training in clinical practice. Aims: The overall purpose of this round table is to: 1. provide an overview...

  5. Routine outcome measurement in mental health service consumers: who should provide support for the self-assessments?

    Science.gov (United States)

    Gelkopf, Marc; Pagorek-Eshel, Shira; Trauer, Tom; Roe, David

    2015-06-01

    This study examined whether mental health community service users completed outcome self-reports differently when assessments were supervised by internal vs. external staff. The examination of potential differences between the two has useful implications for mental health systems that take upon themselves the challenge of Routine Outcome Measurement (ROM), as it might impact allocation of public resources and managed care program planning. 73 consumers completed the Manchester Short Assessment of Quality of Life (MANSA), a shortened version of the Recovery Assessment Scale (RAS), and a functioning questionnaire. Questionnaires were administered, once using support provided by internal staff and once using support provided by external professional staff, with a one-month time interval and in random order. A MANOVA Repeated Measures showed no differences in outcomes of quality of life and recovery between internal and external support. Functioning scores were higher for the internal support when the internal assessments were performed first. Overall, except for the differences in functioning assessment, outcome scores were not determined by the supporting agency. This might indicate that when measuring quality of life and recovery, different supporting methods can be used to gather outcome measures and internal staff might be a good default agency to do this. Differences found in functioning assessment are discussed. Copyright © 2015 Elsevier Ltd. All rights reserved.

  6. Results of total joint arthroplasty and joint preserving surgery in younger patients evaluated by alternative outcome measures.

    Science.gov (United States)

    Klit, Jakob

    2014-04-01

    Knee and hip OA is the clinical and pathological outcome of a functional and structural failure of the joint, resulting in pain and physical dysfunction. Despite the similarity in clinical presentation the pathogenesis seems to differ. Where knee OA is associated with obesity and trauma, hip OA is associated with FAI covering three fundamentally different hip deformities, including acetabular dysplasia; all hypothesized to initiates OA development. Where PAO is used worldwide as a joint-preserving procedure in acetabular dysplasia, TKA and THA are the treatment of choice of end stage OA. Traditional main outcomes are clinically objective surgeon-reported endpoints. Patient perceived outcomes are known to differ from these and PROMs are now recommended as the core set of outcomes. When evaluating the outcome in younger patients, this high demanding group can show ceiling-effects of the scores. The overall aim of this thesis was to investigate the consequences of PAO, TKA, and THA in younger patients evaluated by alternative outcomes in relation to satisfaction, fulfillment of expectations, symptoms of depression, the socioeconomic effects, and abilities in sex-life; to improve patient information prior to PAO, TKA and THA surgery. This PhD thesis is based on three studies. Study I is a cross-sectional survey of preserved hip joints with a mean follow-up of ten years after PAO. One hundred patients (121 PAO's) were eligible for inclusion. An inquiry to the National Patient registry identified 36 of PAO's (in 35 patients) being converted to THA. The 61 remaining patients (80 preserved hip joints) were asked to participate in this questionnaire based follow-up. Fifty-five patients (70 preserved hip-joints) accepted and constituted the study population. All patients received a questionnaire concerning aspects of functional ability, patient satisfaction, expectations, and quality of life following PAO. Both Study II and Study III are prospective multicenter cohort

  7. Early Versus Delayed Passive Range of Motion After Rotator Cuff Repair: A Systematic Review and Meta-analysis.

    Science.gov (United States)

    Kluczynski, Melissa A; Nayyar, Samir; Marzo, John M; Bisson, Leslie J

    2015-08-01

    Postoperative rehabilitation has been shown to affect healing of the rotator cuff after surgical repair. However, it is unknown whether an early or delayed rehabilitation protocol is most beneficial for healing. To determine whether early versus delayed passive range of motion (PROM) affects rotator cuff (RC) retear rates after surgery. Systematic review and meta-analysis. A systematic review of the literature published between January 2003 and February 2014 was conducted. Retear rates were compared for early (within 1 week after surgery) versus delayed (3-6 weeks after surgery) PROM using χ(2) or Fisher exact tests as well as relative risks (RR) and 95% CIs. In the first analysis, data from evidence level 1 studies that directly compared early versus delayed PROM were pooled; and in the second analysis, data from level 1 to 4 studies that did not directly compare early versus delayed PROM were pooled. The second analysis was stratified by tear size and repair method. Twenty-eight studies (1729 repairs) were included. The first analysis of level 1 studies did not reveal a significant difference in retear rates for early (13.7%) versus delayed (10.5%) PROM (P = .36; RR = 1.30 [95% CI, 0.74-2.30]). The second analysis revealed that for ≤3 cm tears, the risk of retear was lower for early versus delayed PROM for transosseous (TO) plus single-row anchor (SA) repairs (18.7% vs 28.2%, P = .02; RR = 0.66 [95% CI, 0.47-0.95]). For >5 cm tears, the risk of retear was greater for early versus delayed PROM for double-row anchor (DA) repairs (56.4% vs 20%, P = .002; RR = 2.82 [95% CI, 1.31-6.07]) and for all repair methods combined (52.2% vs 22.6%, P = .01; RR = 2.31 [95% CI, 1.16-4.61]). There were no statistically significant associations for tears measuring 3 cm. Evidence is lacking with regard to the optimal timing of PROM after RC repair; however, this study suggests that tear size may be influential. © 2014 The Author(s).

  8. Core outcome measurement instruments for clinical trials in nonspecific low back pain

    Science.gov (United States)

    Chiarotto, Alessandro; Boers, Maarten; Deyo, Richard A.; Buchbinder, Rachelle; Corbin, Terry P.; Costa, Leonardo O.P.; Foster, Nadine E.; Grotle, Margreth; Koes, Bart W.; Kovacs, Francisco M.; Lin, C.-W. Christine; Maher, Chris G.; Pearson, Adam M.; Peul, Wilco C.; Schoene, Mark L.; Turk, Dennis C.; van Tulder, Maurits W.; Terwee, Caroline B.; Ostelo, Raymond W.

    2018-01-01

    Abstract To standardize outcome reporting in clinical trials of patients with nonspecific low back pain, an international multidisciplinary panel recommended physical functioning, pain intensity, and health-related quality of life (HRQoL) as core outcome domains. Given the lack of a consensus on measurement instruments for these 3 domains in patients with low back pain, this study aimed to generate such consensus. The measurement properties of 17 patient-reported outcome measures for physical functioning, 3 for pain intensity, and 5 for HRQoL were appraised in 3 systematic reviews following the COSMIN methodology. Researchers, clinicians, and patients (n = 207) were invited in a 2-round Delphi survey to generate consensus (≥67% agreement among participants) on which instruments to endorse. Response rates were 44% and 41%, respectively. In round 1, consensus was achieved on the Oswestry Disability Index version 2.1a for physical functioning (78% agreement) and the Numeric Rating Scale (NRS) for pain intensity (75% agreement). No consensus was achieved on any HRQoL instrument, although the Short Form 12 (SF12) approached the consensus threshold (64% agreement). In round 2, a consensus was reached on an NRS version with a 1-week recall period (96% agreement). Various participants requested 1 free-to-use instrument per domain. Considering all issues together, recommendations on core instruments were formulated: Oswestry Disability Index version 2.1a or 24-item Roland-Morris Disability Questionnaire for physical functioning, NRS for pain intensity, and SF12 or 10-item PROMIS Global Health form for HRQoL. Further studies need to fill the evidence gaps on the measurement properties of these and other instruments. PMID:29194127

  9. Serving the Customer – Do Patient Feedback and Questionnaires Improve Quality?

    Science.gov (United States)

    Keshtgar, Asma; D’Cruz, Len

    2017-01-01

    This review article aims to analyse whether patient feedback and questionnaires improve quality of care. It is recognized that patients cannot assess the medical competence of the clinician, yet patient experience provides an insight into the process of care through the patients’ eyes. Patient experience measures are more reliable for use to assess quality than patient satisfaction surveys. It is inappropriate to use patient satisfaction surveys as a basis for remuneration of dentists within the NHS. Patient Reported Outcome Measures (PROMs) have been a successful measure of patient experience in medicine and their introduction to dentistry needs to be considered. Clinical relevance: This article will enable clinicians to understand the importance of patient experience measures as a more reliable way of improving the quality of clinical care than patient satisfaction surveys.

  10. Measuring Longitudinal Student Performance on Student Learning Outcomes in Sustainability Education

    Science.gov (United States)

    Jarchow, Meghann E.; Formisano, Paul; Nordyke, Shane; Sayre, Matthew

    2018-01-01

    Purpose: The purpose of this paper is to describe the student learning outcomes (SLOs) for a sustainability major, evaluate faculty incorporation of the SLOs into the courses in the sustainability major curriculum and measure student performance on the SLOs from entry into the major to the senior capstone course. Design/methodology/approach:…

  11. Development and evaluation of an Individualized Outcome Measure (IOM) for randomized controlled trials in mental health.

    Science.gov (United States)

    Pesola, Francesca; Williams, Julie; Bird, Victoria; Freidl, Marion; Le Boutillier, Clair; Leamy, Mary; Macpherson, Rob; Slade, Mike

    2015-12-01

    Pre-defined, researcher-selected outcomes are routinely used as the clinical end-point in randomized controlled trials (RCTs); however, individualized approaches may be an effective way to assess outcome in mental health research. The present study describes the development and evaluation of the Individualized Outcome Measure (IOM), which is a patient-specific outcome measure to be used for RCTs of complex interventions. IOM was developed using a narrative review, expert consultation and piloting with mental health service users (n = 20). The final version of IOM comprises two components: Goal Attainment (GA) and Personalized Primary Outcome (PPO). For GA, patients identify one relevant goal at baseline and rate its attainment at follow-up. For PPO, patients choose an outcome domain related to their goal from a pre-defined list at baseline, and complete a standardized questionnaire assessing the chosen outcome domain at baseline and follow-up. A feasibility study indicated that IOM had adequate completion (89%) and acceptability (96%) rates in a clinical sample (n = 84). IOM was then evaluated in a RCT (ISRCTN02507940). GA and PPO components were associated with each other and with the trial primary outcome. The use of the PPO component of IOM as the primary outcome could be considered in future RCTs. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

  12. Quantitative outcome measures for systemic sclerosis-related Microangiopathy - Reliability of image acquisition in Nailfold Capillaroscopy.

    Science.gov (United States)

    Dinsdale, Graham; Moore, Tonia; O'Leary, Neil; Berks, Michael; Roberts, Christopher; Manning, Joanne; Allen, John; Anderson, Marina; Cutolo, Maurizio; Hesselstrand, Roger; Howell, Kevin; Pizzorni, Carmen; Smith, Vanessa; Sulli, Alberto; Wildt, Marie; Taylor, Christopher; Murray, Andrea; Herrick, Ariane L

    2017-09-01

    Nailfold capillaroscopic parameters hold increasing promise as outcome measures for clinical trials in systemic sclerosis (SSc). Their inclusion as outcomes would often naturally require capillaroscopy images to be captured at several time points during any one study. Our objective was to assess repeatability of image acquisition (which has been little studied), as well as of measurement. 41 patients (26 with SSc, 15 with primary Raynaud's phenomenon) and 10 healthy controls returned for repeat high-magnification (300×) videocapillaroscopy mosaic imaging of 10 digits one week after initial imaging (as part of a larger study of reliability). Images were assessed in a random order by an expert blinded observer and 4 outcome measures extracted: (1) overall image grade and then (where possible) distal vessel locations were marked, allowing (2) vessel density (across the whole nailfold) to be calculated (3) apex width measurement and (4) giant vessel count. Intra-rater, intra-visit and intra-rater inter-visit (baseline vs. 1week) reliability were examined in 475 and 392 images respectively. A linear, mixed-effects model was used to estimate variance components, from which intra-class correlation coefficients (ICCs) were determined. Intra-visit and inter-visit reliability estimates (ICCs) were (respectively): overall image grade, 0.97 and 0.90; vessel density, 0.92 and 0.65; mean vessel width, 0.91 and 0.79; presence of giant capillary, 0.68 and 0.56. These estimates were conditional on each parameter being measurable. Within-operator image analysis and acquisition are reproducible. Quantitative nailfold capillaroscopy, at least with a single observer, provides reliable outcome measures for clinical studies including randomised controlled trials. Copyright © 2017 Elsevier Inc. All rights reserved.

  13. Measuring intangibles: Managing intangibles for tangible outcomes in research and innovation

    International Nuclear Information System (INIS)

    Carayannis, E.G.

    2004-01-01

    Knowledge sharing is critical to the success and survival of companies in knowledge intensive industries. It is essential to effectively measure knowledge creation and sharing to facilitate good investment decision making in knowledge management initiatives. This paper will focus on the identification of intangible benefits, the cause and effect relationships, and the applicability of existing metrics to these intangibles. The premise is that existing measurements may not apply. The development of new metrics for managing intangible assets to obtain tangible outcomes is a necessity. (author)

  14. Validation of Patient-Reported Outcomes Measurement Information System Computerized Adaptive Tests Against the Foot and Ankle Outcome Score for 6 Common Foot and Ankle Pathologies.

    Science.gov (United States)

    Koltsov, Jayme C B; Greenfield, Stephen T; Soukup, Dylan; Do, Huong T; Ellis, Scott J

    2017-08-01

    The field of foot and ankle surgery lacks a widely accepted gold-standard patient-reported outcome instrument. With the changing infrastructure of the medical profession, more efficient patient-reported outcome tools are needed to reduce respondent burden and increase participation while providing consistent and reliable measurement across multiple pathologies and disciplines. The primary purpose of the present study was to validate 3 Patient-Reported Outcomes Measurement Information System computer adaptive tests (CATs) most relevant to the foot and ankle discipline against the Foot and Ankle Outcome Score (FAOS) and the Short Form 12 general health status survey in patients with 6 common foot and ankle pathologies. Patients (n = 240) indicated for operative treatment for 1 of 6 common foot and ankle pathologies completed the CATs, FAOS, and Short Form 12 at their preoperative surgical visits, 1 week subsequently (before surgery), and at 6 months postoperatively. The psychometric properties of the instruments were assessed and compared. The Patient-Reported Outcomes Measurement Information System CATs each took less than 1 minute to complete, whereas the FAOS took 6.5 minutes, and the Short Form 12 took 3 minutes. CAT scores were more normally distributed and had fewer floor and ceiling effects than those on the FAOS, which reached as high as 24%. The CATs were more precise than the FAOS and had similar responsiveness and test-retest reliability. The physical function and mobility CATs correlated strongly with the activities subscale of the FAOS, and the pain interference CAT correlated strongly with the pain subscale of the FAOS. The CATs and FAOS were responsive to changes with operative treatment for 6 common foot and ankle pathologies. The CATs performed as well as or better than the FAOS in all aspects of psychometric validity. The Patient-Reported Outcomes Measurement Information System CATs show tremendous potential for improving the study of patient

  15. Outcomes Measurement in Voice Disorders: Application of an Acoustic Index of Dysphonia Severity

    Science.gov (United States)

    Awan, Shaheen N.; Roy, Nelson

    2009-01-01

    Purpose: The purpose of this experiment was to assess the ability of an acoustic model composed of both time-based and spectral-based measures to track change following voice disorder treatment and to serve as a possible treatment outcomes measure. Method: A weighted, four-factor acoustic algorithm consisting of shimmer, pitch sigma, the ratio of…

  16. Can we decide which outcomes should be measured in every clinical trial? A scoping review of the existing conceptual frameworks and processes to develop core outcome sets.

    Science.gov (United States)

    Idzerda, Leanne; Rader, Tamara; Tugwell, Peter; Boers, Maarten

    2014-05-01

    The usefulness of randomized control trials to advance clinical care depends upon the outcomes reported, but disagreement on the choice of outcome measures has resulted in inconsistency and the potential for reporting bias. One solution to this problem is the development of a core outcome set: a minimum set of outcome measures deemed critical for clinical decision making. Within rheumatology the Outcome Measures in Rheumatology (OMERACT) initiative has pioneered the development of core outcome sets since 1992. As the number of diseases addressed by OMERACT has increased and its experience in formulating core sets has grown, clarification and update of the conceptual framework and formulation of a more explicit process of area/domain core set development has become necessary. As part of the update process of the OMERACT Filter criteria to version 2, a literature review was undertaken to compare and contrast the OMERACT conceptual framework with others within and outside rheumatology. A scoping search was undertaken to examine the extent, range, and nature of conceptual frameworks for core set outcome selection in health. We searched the following resources: Cochrane Library Methods Group Register; Medline; Embase; PsycInfo; Environmental Studies and Policy Collection; and ABI/INFORM Global. We also conducted a targeted Google search. Five conceptual frameworks were identified: the WHO tripartite definition of health; the 5 Ds (discomfort, disability, drug toxicity, dollar cost, and death); the International Classification of Functioning (ICF); PROMIS (Patient-Reported Outcomes Measurement System); and the Outcomes Hierarchy. Of these, only the 5 Ds and ICF frameworks have been systematically applied in core set development. Outside the area of rheumatology, several core sets were identified; these had been developed through a limited range of consensus-based methods with varying degrees of methodological rigor. None applied a framework to ensure content validity of

  17. Outcome measures and scar aesthetics in minimally invasive video-assisted parathyroidectomy.

    LENUS (Irish Health Repository)

    Casserly, Paula

    2012-02-01

    OBJECTIVES: To compare the scar outcome of video-assisted parathyroidectomy (VAP) with traditional bilateral cervical exploration (BCE) using previously validated scar assessment scales, and to examine the feasibility of introducing VAP into a general otolaryngology-head and neck practice. DESIGN: A retrospective review of medical records from a prospectively obtained database of patients and long-term follow-up of scar analysis. PATIENTS: The records of 60 patients undergoing parathyroidectomy were reviewed: 29 patients underwent VAP and 31 patients underwent an open procedure with BCE. The groups were matched for age and sex. A total of 46 patients were followed up to assess scar outcome. MAIN OUTCOME MEASURES: The primary outcome was a comparison of patient and observer scar satisfaction between VAP and traditional BCE using validated scar assessment tools: the Patient Scar Assessment Scale and the Manchester Scar Scale. The secondary outcomes were to retrospectively evaluate our results with VAP and to assess the suitability of introducing this technique into a general otolaryngology-head and neck practice. RESULTS: The average scar length in the VAP group was 1.7 cm, and the average scar length in the BCE group was 4.3 cm. The patients in the BCE group scored higher than the patients in the VAP group on the Manchester Scar Scale (P < .01) and on the Patient and Observer Scar Scales (P = .02), indicating a worse scar outcome. The mean operative time in the VAP group was 41 minutes compared with 115 minutes in the open procedure BCE group. There was no difference between the 2 groups in terms of postoperative complications. CONCLUSIONS: Video-assisted parathyroidectomy is a safe and feasible procedure in the setting of a general otolaryngology-head and neck practice, with outcomes and complication rates that are comparable to those of traditional bilateral neck exploration. Both patient and observer analysis demonstrated that VAP was associated with a more

  18. Validation of the Focus on the Outcomes of Communication under Six outcome measure

    Science.gov (United States)

    Thomas-Stonell, Nancy; Oddson, Bruce; Robertson, Bernadette; Rosenbaum, Peter

    2013-01-01

    Aim The aim of this study was to establish the construct validity of the Focus on the Outcomes of Communication Under Six (FOCUS©),a tool designed to measure changes in communication skills in preschool children. Method Participating families' children (n=97; 68 males, 29 females; mean age 2y 8mo; SD 1.04y, range 10mo–4y 11mo) were recruited through eight Canadian organizations. The children were on a waiting list for speech and language intervention. Parents completed the Ages and Stages Questionnaire – Social/Emotional (ASQ-SE) and the FOCUS three times: at assessment and at the start and end of treatment. A second sample (n=28; 16 males 12 females) was recruited from another organization to correlate the FOCUS scores with speech, intelligibility and language measures. Second sample participants ranged in age from 3 years 1 month to 4 years 9 months (mean 3y 11mo; SD 0.41y). At the start and end of treatment, children were videotaped to obtain speech and language samples. Parents and speech–language pathologists (SLPs) independently completed the FOCUS tool. SLPs who were blind to the pre/post order of the videotapes analysed the samples. Results The FOCUS measured significantly more change (p<0.01) during treatment than during the waiting list period. It demonstrated both convergent and discriminant validity against the ASQ-SE. The FOCUS change corresponded to change measured by a combination of clinical speech and language measures (κ=0.31, p<0.05). Conclusion The FOCUS shows strong construct validity as a change-detecting instrument. PMID:23461266

  19. Worse patient-reported outcome after lateral approach than after anterior and posterolateral approach in primary hip arthroplasty. A cross-sectional questionnaire study of 1,476 patients 1-3 years after surgery.

    Science.gov (United States)

    Amlie, Einar; Havelin, Leif I; Furnes, Ove; Baste, Valborg; Nordsletten, Lars; Hovik, Oystein; Dimmen, Sigbjorn

    2014-09-01

    The surgical approach in total hip arthroplasty (THA) is often based on surgeon preference and local traditions. The anterior muscle-sparing approach has recently gained popularity in Europe. We tested the hypothesis that patient satisfaction, pain, function, and health-related quality of life (HRQoL) after THA is not related to the surgical approach. 1,476 patients identified through the Norwegian Arthroplasty Register were sent questionnaires 1-3 years after undergoing THA in the period from January 2008 to June 2010. Patient-reported outcome measures (PROMs) included the hip disability osteoarthritis outcome score (HOOS), the Western Ontario and McMaster Universities osteoarthritis index (WOMAC), health-related quality of life (EQ-5D-3L), visual analog scales (VAS) addressing pain and satisfaction, and questions about complications. 1,273 patients completed the questionnaires and were included in the analysis. Adjusted HOOS scores for pain, other symptoms, activities of daily living (ADL), sport/recreation, and quality of life were significantly worse (p < 0.001 to p = 0.03) for the lateral approach than for the anterior approach and the posterolateral approach (mean differences: 3.2-5.0). These results were related to more patient-reported limping with the lateral approach than with the anterior and posterolateral approaches (25% vs. 12% and 13%, respectively; p < 0.001). Patients operated with the lateral approach reported worse outcomes 1-3 years after THA surgery. Self-reported limping occurred twice as often in patients who underwent THA with a lateral approach than in those who underwent THA with an anterior or posterolateral approach. There were no significant differences in patient-reported outcomes after THA between those who underwent THA with a posterolateral approach and those who underwent THA with an anterior approach.

  20. Measuring Learning Outcomes. A Learner Perspective in Auditing Education

    DEFF Research Database (Denmark)

    Holm, Claus; Steenholdt, Niels

    The ability to provide sensible measures for learning outcomes in accounting education is under increased scrutiny. In this paper we use a learner perspective in auditing education which reflects that some students taking accounting classes also are provided with on-the-job training in accounting...... is part of every day life within most accounting firms. Developing a sound on-the-job training environment is pivotal in the recruitment and design of supervision, and in the end for the expected "successrate" in retaining (valuable) employees. Prior research suggests that scripts or schemas provide...

  1. Correlating nerve conduction studies and clinical outcome measures on carpal tunnel syndrome: lessons from a randomized controlled trial

    NARCIS (Netherlands)

    Schrijver, H.M.; Gerritsen, A.A.M.; Strijers, R.L.; Uitdehaag, B.M.J.; Scholten, R.J.P.M.; Vet, de H.C.W.; Bouter, L.M.

    2005-01-01

    0.4) were found between the neurophysiologic and clinical outcome measures after 12 months, and between the changes in these different categories of outcome measures. This study confirms that the parameters of NCS improve significantly after treatment for CTS, but the modest correlations between

  2. Creating a Novel Video Vignette Stroke Preparedness Outcome Measure Using a Community-Based Participatory Approach.

    Science.gov (United States)

    Skolarus, Lesli E; Murphy, Jillian B; Dome, Mackenzie; Zimmerman, Marc A; Bailey, Sarah; Fowlkes, Sophronia; Morgenstern, Lewis B

    2015-07-01

    Evaluating the efficacy of behavioral interventions for rare outcomes is a challenge. One such topic is stroke preparedness, defined as inteventions to increase stroke symptom recognition and behavioral intent to call 911. Current stroke preparedness intermediate outcome measures are centered on written vignettes or open-ended questions and have been shown to poorly reflect actual behavior. Given that stroke identification and action requires aural and visual processing, video vignettes may improve on current measures. This article discusses an approach for creating a novel stroke preparedness video vignette intermediate outcome measure within a community-based participatory research partnership. A total of 20 video vignettes were filmed of which 13 were unambiguous (stroke or not stroke) as determined by stroke experts and had test discrimination among community participants. Acceptable reliability, high satisfaction, and cultural relevance were found among the 14 community respondents. A community-based participatory approach was effective in creating a video vignette intermediate outcome. Future projects should consider obtaining expert and community feedback prior to filming all the video vignettes to improve the proportion of vignettes that are usable. While content validity and preliminary reliability were established, future studies are needed to confirm the reliability and establish construct validity. © 2014 Society for Public Health Education.

  3. Association between changes on the Negative Symptom Assessment scale (NSA-16) and measures of functional outcome in schizophrenia.

    Science.gov (United States)

    Velligan, Dawn I; Alphs, Larry; Lancaster, Scott; Morlock, Robert; Mintz, Jim

    2009-09-30

    We examined whether changes in negative symptoms, as measured by scores on the 16-item Negative Symptom Assessment scale (NSA-16), were associated with changes in functional outcome. A group of 125 stable outpatients with schizophrenia were assessed at baseline and at 6 months using the NSA-16, the Brief Psychiatric Rating Scale, and multiple measures of functional outcome. Baseline adjusted regression coefficients indicated moderate correlations between negative symptoms and functional outcomes when baseline values of both variables were controlled. Results were nearly identical when we controlled for positive symptoms. Cross-lag panel correlations and Structural Equation Modeling were used to examine whether changes in negative symptoms drove changes in functional outcomes over time. Results indicated that negative symptoms drove the changes in the Social and Occupational Functioning Scale (SOFAS) rather than the reverse. Measures of Quality of Life and measures of negative symptoms may be assessing overlapping constructs or changes in both may be driven by a third variable. Negative symptoms were unrelated over time to scores on a performance-based measure of functional capacity. This study indicates that the relationship between negative symptom change and the change in functional outcomes is complex, and points to potential issues in selection of assessments.

  4. Prospective Memory Deficits in Ecstasy Users: Effects of Longer Ongoing Task Delay Interval

    Science.gov (United States)

    WEINBORN, MICHAEL; WOODS, STEVEN PAUL; NULSEN, CLAIRE; PARK, KATHERINE

    2011-01-01

    Ecstasy use has been associated with neurotoxicity and neurocognitive impairment in a variety of domains, including prospective memory (ProM), which involves the delayed execution of a previously encoded intention in response to a specific cue. The present study adopted the multiprocess theory of ProM to evaluate the hypothesis that ecstasy users would evidence differentially impaired ProM on longer versus shorter ongoing task delays. Ecstasy (n = 31) users, high-risk alcohol users (n = 21) and healthy nonusers (n = 31) completed the short (2-min) and long (15-min) delay ProM scales of the Memory for Intentions Screening Test. Results showed a significant group by ProM delay interaction, such that ecstasy users performed comparably to the comparison groups on short-delay trials, but were impaired on long-delay ProM, particularly for time-based cues. Among the ecstasy users, long-delay ProM was positively associated with risky decision-making, but not with retrospective memory or other aspects of executive functions. These findings suggest that ecstasy users may be particularly susceptible to deficits in strategic target monitoring and maintenance of cue-intention pairings over longer ProM delays. Findings are discussed in the context of their potential everyday functioning (e.g., academic, vocational) and treatment implications for ecstasy users. PMID:22047194

  5. Glioblastoma formation from cell population depleted of Prominin1-expressing cells.

    Directory of Open Access Journals (Sweden)

    Kenji Nishide

    2009-08-01

    Full Text Available Prominin1 (Prom1, also known as CD133 in human has been widely used as a marker for cancer stem cells (CSCs, which self-renew and are tumorigenic, in malignant tumors including glioblastoma multiforme (GBM. However, there is other evidence showing that Prom1-negative cancer cells also form tumors in vivo. Thus it remains controversial whether Prom1 is a bona fide marker for CSCs. To verify if Prom1-expressing cells are essential for tumorigenesis, we established a mouse line, whose Prom1-expressing cells can be eliminated conditionally by a Cre-inducible DTA gene on the Prom1 locus together with a tamoxifen-inducible CreER(TM, and generated glioma-initiating cells (GICs-LD by overexpressing both the SV40 Large T antigen and an oncogenic H-Ras(L61 in neural stem cells of the mouse line. We show here that the tamoxifen-treated GICs-LD (GICs-DTA form tumor-spheres in culture and transplantable GBM in vivo. Thus, our studies demonstrate that Prom1-expressing cells are dispensable for gliomagenesis in this mouse model.

  6. Practice Bulletin No. 172: Premature Rupture of Membranes.

    Science.gov (United States)

    2016-10-01

    Preterm delivery occurs in approximately 12% of all births in the United States and is a major factor that contributes to perinatal morbidity and mortality (1, 2). Preterm premature rupture of membranes (PROM) complicates approximately 3% of all pregnancies in the United States (3). The optimal approach to clinical assessment and treatment of women with term and preterm PROM remains controversial. Management hinges on knowledge of gestational age and evaluation of the relative risks of delivery versus the risks of expectant management (eg, infection, abruptio placentae, and umbilical cord accident). The purpose of this document is to review the current understanding of this condition and to provide management guidelines that have been validated by appropriately conducted outcome-based research when available. Additional guidelines on the basis of consensus and expert opinion also are presented.

  7. Theoretical framework and methodological development of common subjective health outcome measures in osteoarthritis: a critical review

    Directory of Open Access Journals (Sweden)

    Johnston Marie

    2007-03-01

    Full Text Available Abstract Subjective measures involving clinician ratings or patient self-assessments have become recognised as an important tool for the assessment of health outcome. The value of a health outcome measure is usually assessed by a psychometric evaluation of its reliability, validity and responsiveness. However, psychometric testing involves an accumulation of evidence and has recognised limitations. It has been suggested that an evaluation of how well a measure has been developed would be a useful additional criteria in assessing the value of a measure. This paper explored the theoretical background and methodological development of subjective health status measures commonly used in osteoarthritis research. Fourteen subjective health outcome measures commonly used in osteoarthritis research were examined. Each measure was explored on the basis of their i theoretical framework (was there a definition of what was being assessed and was it part of a theoretical model? and ii methodological development (what was the scaling strategy, how were the items generated and reduced, what was the response format and what was the scoring method?. Only the AIMS, SF-36 and WHOQOL defined what they were assessing (i.e. the construct of interest and no measure assessed was part of a theoretical model. None of the clinician report measures appeared to have implemented a scaling procedure or described the rationale for the items selected or scoring system. Of the patient self-report measures, the AIMS, MPQ, OXFORD, SF-36, WHOQOL and WOMAC appeared to follow a standard psychometric scaling method. The DRP and EuroQol used alternative scaling methods. The review highlighted the general lack of theoretical framework for both clinician report and patient self-report measures. This review also drew attention to the wide variation in the methodological development of commonly used measures in OA. While, in general the patient self-report measures had good methodological

  8. Family-centred service coordination in childhood health and disability services: the search for meaningful service outcome measures.

    Science.gov (United States)

    Trute, B; Hiebert-Murphy, D; Wright, A

    2008-05-01

    Potential service outcome measures were tested for their utility in the assessment of the quality of 'family centred' service coordination in the provincial network of children's disability services in Manitoba, Canada. This study is based on in-home survey data provided by 103 mothers at 6 and 18 months following assignment of a 'dedicated' service coordinator. Service outcome indicators included measures of parent self-esteem, parenting stress, family functioning and the need for family support resources. Hierarchical regression analyses showed no relationship between level of quality of family-centred service coordination and standardized psychosocial measures of parent and family functioning. However, family centredness of service coordination was found to predict significant reduction in level of family need for psychosocial support resources after 18 months of contact with a service coordinator. Outcome measures that are focused on specific and tangible results of service coordination appear to be of higher utility in service quality assessment than are more global, standardized measures of parent and family functioning.

  9. Neonatal survival after prolonged preterm premature rupture of membranes before 24 weeks of gestation.

    Science.gov (United States)

    Brumbaugh, Jane E; Colaizy, Tarah T; Nuangchamnong, Nina; O'Brien, Emily A; Fleener, Diedre K; Rijhsinghani, Asha; Klein, Jonathan M

    2014-11-01

    To evaluate neonatal survival after prolonged preterm premature rupture of membranes (PROM) in the era of antenatal corticosteroids, surfactant, and inhaled nitric oxide. A single-center retrospective cohort study of neonates born from 2002-2011 after prolonged (1 week or more) preterm (less than 24 weeks of gestation) rupture of membranes was performed. The primary outcome was survival to discharge. Neonates whose membranes ruptured less than 24 hours before delivery (n=116) were matched (2:1) on gestational age at birth, sex, and antenatal corticosteroid exposure with neonates whose membranes ruptured 1 week or more before delivery (n=58). Analysis used conditional logistic regression for categorical data and Wilcoxon signed rank test for continuous data. The prolonged preterm PROM exposed and unexposed cohorts had survival rates of 90% and 95%, respectively, although underpowered to assess the statistical significance (P=.313). Exposed neonates were more likely have pulmonary hypoplasia (26/58 exposed, 1/114 unexposed, Prupture (20.4 weeks exposed, 22.3 weeks unexposed, P=.189), length of rupture (3.7 weeks exposed, 6.4 weeks unexposed, P=.717), and lowest maximal vertical pocket before 24 weeks of gestation (0 cm exposed, 1.4 cm unexposed, P=.114) did not discriminate between survivors and nonsurvivors after exposure to prolonged preterm PROM. With antenatal steroid exposure and aggressive pulmonary management, survival to discharge after prolonged preterm PROM was 90%. Pulmonary morbidities were common. Of note, the data were limited to women who remained pregnant 1 week or longer after rupture of membranes.

  10. Patient value: its nature, measurement, and role in real world evidence studies and outcomes-based reimbursement.

    Science.gov (United States)

    McKenna, Stephen P; Wilburn, Jeanette

    2018-05-01

    The assessment of "patient value" is fundamental to clinical trials, real world evidence studies, and outcomes-based reimbursement schemes. Measures of health-related quality-of-life (HRQoL) are widely used in health research. Such measures are effective in determining the presence or absence of symptoms and functional ability. However, HRQoL measures were not intended, nor designed, to determine the value to patients of alternative health states. Functions have no intrinsic value-they are a means to fulfil human needs. However, needs can be met in a variety of ways, for example by adopting different functions or by the provision of social services. It is possible to analyze all functions in terms of the needs they satisfy. A needs model has been applied in health research since the 1990s. It is concerned with the extent to which human needs are fulfilled in the presence of disease and its treatment. It is argued that this is the major concern of the patient. Needs-based measures are patient-centric and produce a valid unidimensional index of outcome. Consequently, they provide a direct means of measuring patient value. This approach provides the possibility of evaluating health services in terms of the value they provide to consumers and payers. It also has a role to play in real-world evidence studies and outcomes-based reimbursement. It is recommended that greater attention is given in future to the development of patient-reported outcome measures that provide direct assessments of patient value.

  11. Use of outcome measures in pulmonary hypertension clinical trials.

    Science.gov (United States)

    Parikh, Kishan S; Rajagopal, Sudarshan; Arges, Kristine; Ahmad, Tariq; Sivak, Joseph; Kaul, Prashant; Shah, Svati H; Tapson, Victor; Velazquez, Eric J; Douglas, Pamela S; Samad, Zainab

    2015-09-01

    To evaluate the use of surrogate measures in pulmonary hypertension (PH) clinical trials and how it relates to clinical practice. Studies of pulmonary arterial hypertension (PAH) employ a variety of surrogate measures in addition to clinical events because of a small patient population, participant burden, and costs. The use of these measures in PH drug trials is poorly defined. We searched PubMed/MEDLINE/Embase for randomized or prospective cohort PAH clinical treatment trials from 1985 to 2013. Extracted data included intervention, trial duration, study design, patient characteristics, and primary and secondary outcome measures. To compare with clinical practice, we assessed the use of surrogate measures in a clinical sample of patients on PH medications at Duke University Medical Center between 2003 and 2014. Between 1985 and 2013, 126 PAH trials were identified and analyzed. Surrogate measures served as primary endpoints in 119 trials (94.0%). Inclusion of invasive hemodynamics decreased over time (78.6%, 75.0%, 52.2%; P for trend = .02), while functional testing (7.1%, 60.0%, 81.5%; P for trend clinical assessments regularly incorporated serial echocardiography and 6-minute walk distance tests (92% and 95% of patients, respectively) and repeat measurement of invasive hemodynamics (46% of patients). The majority of PAH trials have utilized surrogate measures as primary endpoints. The use of these surrogate endpoints has evolved significantly over time with increasing use of patient-centered endpoints and decreasing or stable use of imaging and invasive measures. In contrast, imaging and invasive measures are commonly used in contemporary clinical practice. Further research is needed to validate and standardize currently used measures. Copyright © 2015 Elsevier Inc. All rights reserved.

  12. Kinematic measures for upper limb robot-assisted therapy following stroke and correlations with clinical outcome measures: A review.

    Science.gov (United States)

    Tran, Vi Do; Dario, Paolo; Mazzoleni, Stefano

    2018-03-01

    This review classifies the kinematic measures used to evaluate post-stroke motor impairment following upper limb robot-assisted rehabilitation and investigates their correlations with clinical outcome measures. An online literature search was carried out in PubMed, MEDLINE, Scopus and IEEE-Xplore databases. Kinematic parameters mentioned in the studies included were categorized into the International Classification of Functioning, Disability and Health (ICF) domains. The correlations between these parameters and the clinical scales were summarized. Forty-nine kinematic parameters were identified from 67 articles involving 1750 patients. The most frequently used parameters were: movement speed, movement accuracy, peak speed, number of speed peaks, and movement distance and duration. According to the ICF domains, 44 kinematic parameters were categorized into Body Functions and Structure, 5 into Activities and no parameters were categorized into Participation and Personal and Environmental Factors. Thirteen articles investigated the correlations between kinematic parameters and clinical outcome measures. Some kinematic measures showed a significant correlation coefficient with clinical scores, but most were weak or moderate. The proposed classification of kinematic measures into ICF domains and their correlations with clinical scales could contribute to identifying the most relevant ones for an integrated assessment of upper limb robot-assisted rehabilitation treatments following stroke. Increasing the assessment frequency by means of kinematic parameters could optimize clinical assessment procedures and enhance the effectiveness of rehabilitation treatments. Copyright © 2018 IPEM. Published by Elsevier Ltd. All rights reserved.

  13. Anastomotic leakage as an outcome measure for quality of colorectal cancer surgery

    NARCIS (Netherlands)

    Snijders, H. S.; Henneman, D.; van Leersum, N. L.; ten Berge, M.; Fiocco, M.; Karsten, T. M.; Havenga, K.; Wiggers, T.; Dekker, J. W.; Tollenaar, R. A. E. M.; Wouters, M. W. J. M.

    Introduction When comparing mortality rates between hospitals to explore hospital performance, there is an important role for adjustment for differences in case-mix. Identifying outcome measures that are less influenced by differences in case-mix may be valuable. The main goal of this study was to

  14. A Comparison of Several Outcome Measures Used to Evaluate a Psychiatric Clerkship.

    Science.gov (United States)

    Cuerdon, Timothy; And Others

    The teaching of interviewing skills is increasingly incorporated into clinical medicine courses in American medical schools, yet the attempts to evaluate the effectiveness of these efforts have been woefully inadequate. Typical outcome measures have included paper and pencil tests of knowledge, preceptor evaluations of clinical performance, and…

  15. CD133 expression in chemo-resistant Ewing sarcoma cells

    Directory of Open Access Journals (Sweden)

    Kovar Heinrich

    2010-03-01

    Full Text Available Abstract Background Some human cancers demonstrate cellular hierarchies in which tumor-initiating cancer stem cells generate progeny cells with reduced tumorigenic potential. This cancer stem cell population is proposed to be a source of therapy-resistant and recurrent disease. Ewing sarcoma family tumors (ESFT are highly aggressive cancers in which drug-resistant, relapsed disease remains a significant clinical problem. Recently, the cell surface protein CD133 was identified as a putative marker of tumor-initiating cells in ESFT. We evaluated ESFT tumors and cell lines to determine if high levels of CD133 are associated with drug resistance. Methods Expression of the CD133-encoding PROM1 gene was determined by RT-PCR in ESFT tumors and cell lines. CD133 protein expression was assessed by western blot, FACS and/or immunostaining. Cell lines were FACS-sorted into CD133+ and CD133- fractions and proliferation, colony formation in soft agar, and in vivo tumorigenicity compared. Chemosensitivity was measured using MTS (3-(4,5-dimethylthiazol-2-yl-5-(3-carboxy-methoxyphenyl-2-(4-sulfophenyl-2H-tetrazolium assays. Results PROM1 expression was either absent or extremely low in most tumors. However, PROM1 was highly over-expressed in 4 of 48 cases. Two of the 4 patients with PROM1 over-expressing tumors rapidly succumbed to primary drug-resistant disease and two are long-term, event-free survivors. The expression of PROM1 in ESFT cell lines was similarly heterogeneous. The frequency of CD133+ cells ranged from 2-99% and, with one exception, no differences in the chemoresistance or tumorigenicity of CD133+ and CD133- cell fractions were detected. Importantly, however, the STA-ET-8.2 cell line was found to retain a cellular hierarchy in which relatively chemo-resistant, tumorigenic CD133+ cells gave rise to relatively chemo-sensitive, less tumorigenic, CD133- progeny. Conclusions Up to 10% of ESFT express high levels of PROM1. In some tumors and cell

  16. Implementing patient-reported outcome measures in palliative care clinical practice: a systematic review of facilitators and barriers.

    Science.gov (United States)

    Antunes, Bárbara; Harding, Richard; Higginson, Irene J

    2014-02-01

    Many patient-reported outcome measures have been developed in the past two decades, playing an increasingly important role in palliative care. However, their routine use in practice has been slow and difficult to implement. To systematically identify facilitators and barriers to the implementation of patient-reported outcome measures in different palliative care settings for routine practice, and to generate evidence-based recommendations, to inform the implementation process in clinical practice. Systematic literature review and narrative synthesis. Medline, PsycInfo, Cumulative Index to Nursing and Allied Health Literature, Embase and British Nursing Index were systematically searched from 1985. Hand searching of reference lists for all included articles and relevant review articles was performed. A total of 3863 articles were screened. Of these, 31 articles met the inclusion criteria. First, data were integrated in the main themes: facilitators, barriers and lessons learned. Second, each main theme was grouped into either five or six categories. Finally, recommendations for implementation on outcome measures at management, health-care professional and patient levels were generated for three different points in time: preparation, implementation and assessment/improvement. Successful implementation of patient-reported outcome measures should be tailored by identifying and addressing potential barriers according to setting. Having a coordinator throughout the implementation process seems to be key. Ongoing cognitive and emotional processes of each individual should be taken into consideration during changes. The educational component prior to the implementation is crucial. This could promote ownership and correct use of the measure by clinicians, potentially improving practice and the quality of care provided through patient-reported outcome measure data use in clinical decision-making.

  17. The Premature Ejaculation Profile: validation of self-reported outcome measures for research and practice.

    Science.gov (United States)

    Patrick, Donald L; Giuliano, François; Ho, Kai Fai; Gagnon, Dennis D; McNulty, Pauline; Rothman, Margaret

    2009-02-01

    To evaluate the reliability and validity of the Premature Ejaculation Profile (PEP), a self-reported outcome instrument for evaluating domains of PE and its treatment, comprised of four single-item measures, a profile, and an index score. Data were from men participating in observational studies in the USA (PE, 207 men; non-PE, 1380) and Europe (PE, 201; non-PE, 914) and from men with PE (1238) participating in a phase III randomized, placebo-controlled clinical trial of dapoxetine. The PEP contains four measures: perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse, and interpersonal difficulty related to ejaculation, each assessed on five-point response scales. Test-retest reliability, known-groups validity, and ability to detect a patient-reported global impression of change (PGI) in condition were evaluated for the individual PEP measures and a PEP index score (the mean of all four measures). Profile analysis was conducted using multivariate analysis of variance. All PEP measures showed acceptable reliability (intraclass correlation coefficients ranged from 0.66 to 0.83) and mean scores for all measures differed significantly between PE and non-PE groups (P measures. The PEP profiles of men with and without PE differed significantly (P measure for use in monitoring outcomes of men with PE.

  18. DEFINING THE RELEVANT OUTCOME MEASURES IN MEDICAL DEVICE ASSESSMENTS: AN ANALYSIS OF THE DEFINITION PROCESS IN HEALTH TECHNOLOGY ASSESSMENT.

    Science.gov (United States)

    Jacobs, Esther; Antoine, Sunya-Lee; Prediger, Barbara; Neugebauer, Edmund; Eikermann, Michaela

    2017-01-01

    Defining relevant outcome measures for clinical trials on medical devices (MD) is complex, as there is a large variety of potentially relevant outcomes. The chosen outcomes vary widely across clinical trials making the assessment in evidence syntheses very challenging. The objective is to provide an overview on the current common procedures of health technology assessment (HTA) institutions in defining outcome measures in MD trials. In 2012-14, the Web pages of 126 institutions involved in HTA were searched for methodological manuals written in English or German that describe methods for the predefinition process of outcome measures. Additionally, the institutions were contacted by email. Relevant information was extracted. All process steps were performed independently by two reviewers. Twenty-four manuals and ten responses from the email request were included in the analysis. Overall, 88.5 percent of the institutions describe the type of outcomes that should be considered in detail and 84.6 percent agree that the main focus should be on patient relevant outcomes. Specifically related to MD, information could be obtained in 26 percent of the included manuals and email responses. Eleven percent of the institutions report a particular consideration of MD related outcomes. This detailed analysis on common procedures of HTA institutions in the context of defining relevant outcome measures for the assessment of MD shows that standardized procedures for MD from the perspective of HTA institutions are not widespread. This leads to the question if a homogenous approach should be implemented in the field of HTA on MD.

  19. High-density cervical ureaplasma urealyticum colonization in pregnant women

    Directory of Open Access Journals (Sweden)

    Ranđelović Gordana

    2006-01-01

    Full Text Available Background/aim: Ureaplasma urealyticum, a common commensal of the female lower genital tract, has been observed as an important opportunistic pathogen during pregnancy. The aims of this study were to determine the degree of cervical colonization with U. urealyticum in pregnant women with risk pregnancy and in pregnant women with normal term delivery and to evaluate the correlation between high-density cervical U. urealyticum colonization and premature rupture of membranes (PROM as well. Methods. This research was conducted on the samples comprising 130 hospitalized pregnant women with threatening preterm delivery and premature rupture of membranes. The control group consisted of 39 pregnant women with term delivery without PROM. In addition to standard bacteriological examination and performing direct immunofluorescence test to detect Chlamydia trachomatis, cervical swabs were also examined for the presence of U. urealyticum and Mycoplasma hominis by commercially available Mycofast Evolution 2 test (International Microbio, France. Results. The number of findings with isolated high-density U. urealyticum in the target group was 69 (53.08%, while in the control group was 14 (35.90%. Premature rupture of membranes (PROM occurred in 43 (33.08% examinees: 29 were pPROM, and 14 were PROM. The finding of U.urealyticum ≥104 was determined in 25 (58.14% pregnant women with rupture, 17 were pPROM, and 8 were PROM. There was statistically significant difference in the finding of high-density U. urealyticum between the pregnant women with PROM and the control group (χ² = 4.06, p < 0.05. U. urealyticum was predominant bacterial species found in 62.79% of isolates in the PROM cases, while in 32.56% it was isolated alone. Among the 49 pregnant women with preterm delivery, pPROM occurred in 29 (59.18% examinees, and in 70.83% of pregnant women with findings of high-density U. urealyticum pPROM was observed. Conclusion. Cervical colonization with U

  20. An Introduction to Item Response Theory for Patient-Reported Outcome Measurement

    Science.gov (United States)

    Nguyen, Tam H.; Han, Hae-Ra; Kim, Miyong T.

    2015-01-01

    The growing emphasis on patient-centered care has accelerated the demand for high-quality data from patient-reported outcome (PRO) measures. Traditionally, the development and validation of these measures has been guided by classical test theory. However, item response theory (IRT), an alternate measurement framework, offers promise for addressing practical measurement problems found in health-related research that have been difficult to solve through classical methods. This paper introduces foundational concepts in IRT, as well as commonly used models and their assumptions. Existing data on a combined sample (n = 636) of Korean American and Vietnamese American adults who responded to the High Blood Pressure Health Literacy Scale and the Patient Health Questionnaire-9 are used to exemplify typical applications of IRT. These examples illustrate how IRT can be used to improve the development, refinement, and evaluation of PRO measures. Greater use of methods based on this framework can increase the accuracy and efficiency with which PROs are measured. PMID:24403095

  1. Health-related quality of life, visual function and treatment satisfaction following intravitreal dexamethasone implant for diabetic macular edema

    Directory of Open Access Journals (Sweden)

    Ramu J

    2017-03-01

    Full Text Available Jayashree Ramu,1 Irini Chatziralli,1 Yit Yang,2 Geeta Menon,3 Clare Bailey,4 Michael Eckstein,5 Phil Hykin,1 Sobha Sivaprasad1 On behalf of the OZDRY Study Group 1NIHR Moorfields Biomedical Research Centre, London, 2The Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, 3Frimley Health NHS Foundation Trust, Surrey, 4Bristol Eye Hospital, Bristol, 5Brighton and Sussex University Hospital, Brighton, UK Purpose: The aim of this study was to explore and describe quantitatively patient-reported outcome measures (PROMs, ie, health-related quality of life (QoL, visual function and treatment satisfaction, in patients with diabetic macular edema (DME receiving two different regimens of Ozurdex (intravitreal dexamethasone implant. Methods: In this multicenter, prospective study, 100 patients with center-involving refractory DME were randomized 1:1 to either five monthly fixed dosing or optical coherence tomography (OCT-guided pro re nata (PRN regimen of dexamethasone intravitreal implant therapy. The primary outcome was the difference between arms in change in PROMs and health-related QoL from baseline to 12 months, as measured by the Retinopathy-Dependent Quality of Life (RetDQoL questionnaire, Visual Function Questionnaire-25 (VFQ-25 and Retinopathy Treatment Satisfaction Questionnaire (RetTSQ. Results: There was no statistically significant difference in the RetDQoL score and VFQ-25 score at month 12 compared to those at baseline, whereas the total mean RetTSQ score increased significantly at the exit visit. The two treatment arms did not differ significantly regarding the change in PROMs and health-related QoL questionnaires. Logistic regression analysis showed that visual acuity (VA of ≥55 letters, central foveal thickness <300 µm and macular volume <9.2 mm3 at the exit visit (month 12 predicted a higher change in RetTSQ. Conclusion: This study showed that there is a statistically significant improvement in treatment satisfaction, as

  2. A systematic review of studies that aim to determine which outcomes to measure in clinical trials in children.

    Directory of Open Access Journals (Sweden)

    Ian Sinha

    2008-04-01

    Full Text Available In clinical trials the selection of appropriate outcomes is crucial to the assessment of whether one intervention is better than another. Selection of inappropriate outcomes can compromise the utility of a trial. However, the process of selecting the most suitable outcomes to include can be complex. Our aim was to systematically review studies that address the process of selecting outcomes or outcome domains to measure in clinical trials in children.We searched Cochrane databases (no date restrictions in December 2006; and MEDLINE (1950 to 2006, CINAHL (1982 to 2006, and SCOPUS (1966 to 2006 in January 2007 for studies of the selection of outcomes for use in clinical trials in children. We also asked a group of experts in paediatric clinical research to refer us to any other relevant studies. From these articles we extracted data on the clinical condition of interest, description of the method used to select outcomes, the people involved in the selection process, the outcomes selected, and limitations of the method as defined by the authors. The literature search identified 8,889 potentially relevant abstracts. Of these, 70 were retrieved, and 25 were included in the review. These studies described the work of 13 collaborations representing various paediatric specialties including critical care, gastroenterology, haematology, psychiatry, neurology, respiratory paediatrics, rheumatology, neonatal medicine, and dentistry. Two groups utilised the Delphi technique, one used the nominal group technique, and one used both methods to reach a consensus about which outcomes should be measured in clinical trials. Other groups used semistructured discussion, and one group used a questionnaire-based survey. The collaborations involved clinical experts, research experts, and industry representatives. Three groups involved parents of children affected by the particular condition.Very few studies address the appropriate choice of outcomes for clinical research

  3. Outcome measures in studies on the use of oxytocin for the treatment of delay in labour: A systematic review.

    LENUS (Irish Health Repository)

    Begley, Cecily M

    2014-07-01

    to identify primary and secondary outcome measures in randomised trials, and systematic reviews of randomised trials, measuring effectiveness of oxytocin for treatment of delay in the first and second stages of labour, and to identify any positive health-focussed outcomes used.

  4. Student Identification with Business Education Models: Measurement and Relationship to Educational Outcomes

    Science.gov (United States)

    Halbesleben, Jonathon R. B.; Wheeler, Anthony R.

    2009-01-01

    Although management scholars have provided a variety of metaphors to describe the role of students in management courses, researchers have yet to explore students' identification with the models and how they are linked to educational outcomes. This article develops a measurement tool for students' identification with business education models and…

  5. Using theory and evidence to drive measurement of patient, nurse and organizational outcomes of professional nursing practice.

    Science.gov (United States)

    Jeffs, Lianne; Sidani, Souraya; Rose, Donald; Espin, Sherry; Smith, Orla; Martin, Kirsten; Byer, Charlie; Fu, Kaiyan; Ferris, Ella

    2013-04-01

    An evolving body of literature suggests that the implementation of evidence based clinical and professional guidelines and strategies can improve patient care. However, gaps exist in our understanding of the effect of implementation of guidelines on outcomes, particularly patient outcomes. To address this gap, a measurement framework was developed to assess the impact of an organization-wide implementation of two nursing-centric best-practice guidelines on patient, nurse and organizational level outcomes. From an implementation standpoint, we anticipate that our data will show improvements in the following: (i) patient satisfaction scores and safety outcomes; (ii) nurses ability to value and engage in evidence based practice; and (iii) organizational support for evidence-informed nursing care that results in quality patient outcomes. Our measurement framework and multifaceted methodological approach outlined in this paper might serve as a blueprint for other organizations in their efforts to evaluate the impacts associated with implementation of clinical and professional guidelines and best practices. © 2013 Wiley Publishing Asia Pty Ltd.

  6. Outcome-centered antiepileptic therapy: Rate, rhythm and relief.: Implementing AAN Epilepsy Quality Measures in clinical practice.

    Science.gov (United States)

    D'Cruz, O'Neill

    2015-12-01

    Clinicians who manage patients with epilepsy are expected to assess the relevance of clinical trial results to their practice, integrate new treatments into the care algorithm, and implement epilepsy quality measures, with the overall goal of improving patient outcomes. A disease-based clinical framework that helps with choice and combinations of interventions facilitates provision of efficient, cost-effective, and high-quality care. This article addresses the current conceptual framework that informs clinical evaluation of epilepsy, explores gaps between development of treatment options, quality measures and clinical goals, and proposes an outcome-centered approach that bridges these gaps with the aim of improving patient and population-level clinical outcomes in epilepsy. Copyright © 2015 The Author. Published by Elsevier Inc. All rights reserved.

  7. An investigation of outcome expectancies as a predictor of treatment response for combat veterans with PTSD: comparison of clinician, self-report, and biological measures.

    Science.gov (United States)

    Price, Matthew; Maples, Jessica L; Jovanovic, Tanja; Norrholm, Seth D; Heekin, Mary; Rothbaum, Barbara O

    2015-06-01

    Outcome expectancy, or the degree to which a client believes that therapy will result in improvement, is related to improved treatment outcomes for multiple disorders. There is a paucity of research investigating this relation in regards to posttraumatic stress disorder (PTSD). Additionally, the bulk of the research on outcome expectancy and treatment outcomes has relied mostly on self-report outcome measures. The relation between outcome expectancy on self-report measures, clinician-rated measures, and two biological indices (fear-potentiated startle and cortisol reactivity) of PTSD symptoms was explored. The sample included combat veterans (N = 116) treated with virtual reality exposure therapy for PTSD. Results supported a negative association between outcome expectancy and both self-report and clinician-rated symptoms at the conclusion of treatment, but outcome expectancy was related to the magnitude of change during treatment for self-report measures only. Outcome expectancy was unrelated to biological measures of treatment response. These findings suggest that outcome expectancy may be related to patient and clinician perceptions of outcomes, but not biological indices of outcome for PTSD. © 2015 Wiley Periodicals, Inc.

  8. Vision and vision-related outcome measures in multiple sclerosis

    Science.gov (United States)

    Balcer, Laura J.; Miller, David H.; Reingold, Stephen C.

    2015-01-01

    Visual impairment is a key manifestation of multiple sclerosis. Acute optic neuritis is a common, often presenting manifestation, but visual deficits and structural loss of retinal axonal and neuronal integrity can occur even without a history of optic neuritis. Interest in vision in multiple sclerosis is growing, partially in response to the development of sensitive visual function tests, structural markers such as optical coherence tomography and magnetic resonance imaging, and quality of life measures that give clinical meaning to the structure-function correlations that are unique to the afferent visual pathway. Abnormal eye movements also are common in multiple sclerosis, but quantitative assessment methods that can be applied in practice and clinical trials are not readily available. We summarize here a comprehensive literature search and the discussion at a recent international meeting of investigators involved in the development and study of visual outcomes in multiple sclerosis, which had, as its overriding goals, to review the state of the field and identify areas for future research. We review data and principles to help us understand the importance of vision as a model for outcomes assessment in clinical practice and therapeutic trials in multiple sclerosis. PMID:25433914

  9. Large variation in measures used to assess outcomes of opioid dependence treatment: A systematic review of longitudinal observational studies.

    Science.gov (United States)

    Wiessing, Lucas; Ferri, Marica; Darke, Shane; Simon, Roland; Griffiths, Paul

    2017-10-02

    Treatment outcomes for drug users are critical for informing policy and therapeutic practice. The coherence of outcomes, changes and drug use measures from observational studies on opioid use treatment were reviewed. Systematic review of the literature for longitudinal observational studies, from 1980 through November 2015, in all languages, with data on treated opioid users, using Pubmed, the Cochrane Library and additional strategies (e.g. Pubmed function 'related citations' and checking reference lists of eligible studies). Twenty-seven studies were included (11 countries, 85 publications, recruitment 1962-2009). Baseline n was >65 686 and median follow-up 34.5 months (21 studies) or 51.4 person-months (10 studies). Eight outcome domains were identified: 'drug use' (21/27 studies), 'crime' (13), 'health' (13), 'treatment-related' outcomes (16), 'social functioning' (13), 'harms' (8), 'mortality' (13) and 'economic estimates' (2 studies). All studies using drug use outcomes included a binary (abstinence) category in at least one measure. Studies typically reported outcomes on less than half (on average 3.7 or 46%) of the eight outcome domains, while the average was 5.1 (64%) in seven studies initiated since 2000. Wide variation exists in outcome measures found in longitudinal observational studies of treatment of opioid users. This reduces replicability of studies and suggests a lack of common expectations on treatment success. Future studies should consider using all or most of eight outcome domains identified (excluding economic analyses if unfeasible), non-binary measures and amount/value of drugs used and consensus meetings with joint ownership of scientific, treatment and patient communities. © 2017 Australasian Professional Society on Alcohol and other Drugs.

  10. A systematic literature search to identify performance measure outcomes used in clinical studies of racehorses.

    Science.gov (United States)

    Wylie, C E; Newton, J R

    2018-05-01

    Racing performance is often used as a measurable outcome variable in research studies investigating clinical diagnoses or interventions. However, the use of many different performance measures largely precludes conduct of meaningful comparative studies and, to date, those being used have not been collated. To systematically review the veterinary scientific literature for the use of racing performance as a measurable outcome variable in clinical studies of racehorses, collate and identify those most popular, and identify their advantages and disadvantages. Systematic literature search. The search criteria "((racing AND performance) AND (horses OR equidae))" were adapted for both MEDLINE and CAB Abstracts databases. Data were collected in standardised recording forms for binary, categorical and quantitative measures, and the use of performance indices. In total, 217 studies that described racing performance were identified, contributing 117 different performance measures. No one performance measure was used in all studies, despite 90.3% using more than one variable. Data regarding race starts and earnings were used most commonly, with 88.0% and 54.4% of studies including at least one measure of starts and earnings, respectively. Seventeen variables were used 10 times or more, with the top five comprising: 'return to racing', 'number of starts', 'days to first start', 'earnings per period of time' and 'earnings per start'. The search strategies may not have identified all relevant papers, introducing bias to the review. Performance indices have been developed to improve assessment of interventions; however, they are not widely adopted in the scientific literature. Use of the two most commonly identified measures, whether the horse returned to racing and number of starts over a defined period of time, would best facilitate future systematic reviews and meta-analyses in advance of the development of a gold-standard measure of race performance outcome. © 2017 EVJ Ltd.

  11. Variations in Definitions and Outcome Measures in Gastroesophageal Reflux Disease: A Systematic Review

    NARCIS (Netherlands)

    Singendonk, Maartje M. J.; Brink, Anna J.; Steutel, Nina F.; van Etten-Jamaludin, Faridi S.; van Wijk, Michiel P.; Benninga, Marc A.; Tabbers, Merit M.

    2017-01-01

    CONTEXT: Gastroesophageal reflux (GER) is defined as GER disease (GERD) when it leads to troublesome symptoms and/or complications. We hypothesized that definitions and outcome measures in randomized controlled trials (RCTs) on pediatric GERD would be heterogeneous. OBJECTIVES: Systematically assess

  12. Patient empowerment: The need to consider it as a measurable patient-reported outcome for chronic conditions

    Science.gov (United States)

    2012-01-01

    Background Health policy in the UK and elsewhere is prioritising patient empowerment and patient evaluations of healthcare. Patient reported outcome measures now take centre-stage in implementing strategies to increase patient empowerment. This article argues for consideration of patient empowerment itself as a directly measurable patient reported outcome for chronic conditions, highlights some issues in adopting this approach, and outlines a research agenda to enable healthcare evaluation on the basis of patient empowerment. Discussion Patient empowerment is not a well-defined construct. A range of condition-specific and generic patient empowerment questionnaires have been developed; each captures a different construct e.g. personal control, self-efficacy/self-mastery, and each is informed by a different implicit or explicit theoretical framework. This makes it currently problematic to conduct comparative evaluations of healthcare services on the basis of patient empowerment. A case study (clinical genetics) is used to (1) illustrate that patient empowerment can be a valued healthcare outcome, even if patients do not obtain health status benefits, (2) provide a rationale for conducting work necessary to tighten up the patient empowerment construct (3) provide an exemplar to inform design of interventions to increase patient empowerment in chronic disease. Such initiatives could be evaluated on the basis of measurable changes in patient empowerment, if the construct were properly operationalised as a patient reported outcome measure. To facilitate this, research is needed to develop an appropriate and widely applicable generic theoretical framework of patient empowerment to inform (re)development of a generic measure. This research should include developing consensus between patients, clinicians and policymakers about the content and boundaries of the construct before operationalisation. This article also considers a number of issues for society and for healthcare

  13. Event-Based Prospective Memory Is Resistant but Not Immune to Proactive Interference.

    Science.gov (United States)

    Oates, Joyce M; Peynircioglu, Zehra F

    2016-01-01

    Recent evidence suggests that proactive interference (PI) does not hurt event-based prospective memory (ProM) the way it does retrospective memory (RetroM) (Oates, Peynircioglu, & Bates, 2015). We investigated this apparent resistance further. Introduction of a distractor task to ensure we were testing ProM rather than vigilance in Experiment 1 and tripling the number of lists to provide more opportunity for PI buildup in Experiment 2 still did not produce performance decrements. However, when the ProM task was combined with a RetroM task in Experiment 3, a comparable buildup and release was observed also in the ProM task. It appears that event based ProM is indeed somewhat resistant to PI, but this resistance can break down when the ProM task comprises the same stimuli as in an embedded RetroM task. We discuss the results using the ideas of cue overload and distinctiveness as well as shared attentional and working memory resources.

  14. Antibiotics for preterm rupture of membranes.

    Science.gov (United States)

    Kenyon, Sara; Boulvain, Michel; Neilson, James P

    2010-08-04

    Premature birth carries substantial neonatal morbidity and mortality. Subclinical infection is associated with preterm rupture of membranes (PROM). Prophylactic maternal antibiotic therapy might lessen infectious morbidity and delay labour, but could suppress labour without treating underlying infection. To evaluate the immediate and long-term effects of administering antibiotics to women with PROM before 37 weeks, on maternal infectious morbidity, neonatal morbidity and mortality, and longer-term childhood development. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (29 April 2010). Randomised controlled trials comparing antibiotic administration with placebo that reported clinically relevant outcomes were included as were trials of different antibiotics. Trials in which no placebo was used were included for the outcome of perinatal death alone. We extracted data from each report without blinding of either the results or the treatments that women received. We sought unpublished data from a number of authors. We included 22 trials, involving 6800 women and babies.The use of antibiotics following PROM is associated with statistically significant reductions in chorioamnionitis (average risk ratio (RR) 0.66, 95% confidence interval (CI) 0.46 to 0.96, and a reduction in the numbers of babies born within 48 hours (average RR 0.71, 95% CI 0.58 to 0.87) and seven days of randomisation (average RR 0.79, 95% CI 0.71 to 0.89). The following markers of neonatal morbidity were reduced: neonatal infection (RR 0.67, 95% CI 0.52 to 0.85), use of surfactant (RR 0.83, 95% CI 0.72 to 0.96), oxygen therapy (RR 0.88, 95% CI 0.81 to 0.96), and abnormal cerebral ultrasound scan prior to discharge from hospital (RR 0.81, 95% CI 0.68 to 0.98). Co-amoxiclav was associated with an increased risk of neonatal necrotising enterocolitis (RR 4.72, 95% CI 1.57 to 14.23).One study evaluated the children's health at seven years of age (ORACLE Children Study) and found

  15. Outcome Rating Scale and Session Rating Scale in Psychological Practice: Clinical Utility of Ultra-Brief Measures

    Science.gov (United States)

    Campbell, Alistair; Hemsley, Samantha

    2009-01-01

    The validity and reliability of the Outcome Rating Scale (ORS) and the Session Rating Scale (SRS) were evaluated against existing longer measures, including the Outcome Questionnaire-45, Working Alliance Inventory, Depression Anxiety Stress Scale-21, Quality of Life Scale, Rosenberg Self-Esteem Scale and General Self-efficacy Scale. The measures…

  16. Manual for procesorienteret musikterapi med personer med BPD

    DEFF Research Database (Denmark)

    Hannibal, Niels; Pedersen, Inge Nygaard; Bonde, Lars Ole

    2012-01-01

    Denne artikel introducerer et musikterapeutisk behandlingskoncept kaldet: Procesorienteret Musikterapi (PROM). PROM er et forsøg på at formulere en principiel ramme for musikterapi i psykiatrien, som dels tager udgangspunkt i 17 års klinisk erfaring, dels stiler mod at være ”best practice”. PROM ...

  17. Minimum data set to measure rehabilitation needs and health outcome after major trauma: application of an international framework.

    Science.gov (United States)

    Hoffman, Karen P; Playford, Diane E; Grill, Eva; Soberg, Helene L; Brohi, Karim

    2016-06-01

    Measurement of long term health outcome after trauma remains non-standardized and ambiguous which limits national and international comparison of burden of injuries. The World Health Organization (WHO) has recommended the application of the International Classification of Function, Disability and Health (ICF) to measure rehabilitation and health outcome worldwide. No previous poly-trauma studies have applied the ICF comprehensively to evaluate outcome after injury. To apply the ICF categorization in patients with traumatic injuries to identify a minimum data set of important rehabilitation and health outcomes to enable national and international comparison of outcome data. A mixed methods design of patient interviews and an on-line survey. An ethnically diverse urban major trauma center in London. Adult patients with major traumatic injuries (poly-trauma) and international health care professionals (HCPs) working in acute and post-acute major trauma settings. Mixed methods investigated patients and health care professionals (HCPs) perspectives of important rehabilitation and health outcomes. Qualitative patient data and quantitative HCP data were linked to ICF categories. Combined data were refined to identify a minimum data set of important rehabilitation and health outcome categories. Transcribed patient interview data (N.=32) were linked to 234 (64%) second level ICF categories. Two hundred and fourteen HCPs identified 121 from a possible 140 second level ICF categories (86%) as relevant and important. Patients and HCPs strongly agreed on ICF body structures and body functions categories which include temperament, energy and drive, memory, emotions, pain and repair function of the skin. Conversely, patients prioritised domestic tasks, recreation and work compared to HCP priorities of self-care and mobility. Twenty six environmental factors were identified. Patient and HCP data were refined to recommend a 109 possible ICF categories for a minimum data set. The

  18. Challenges and Opportunities in Using Patient-Reported Outcomes in Quality Measurement in Rheumatology

    OpenAIRE

    Wahl, Elizabeth; Yazdany, Jinoos

    2016-01-01

    Use of Patient-reported outcome measures (PROs) in rheumatology research is widespread, but use of PRO data to evaluate the quality of rheumatologic care delivered is less well established. This article reviews the use of PROs in assessing healthcare quality, and highlights challenges and opportunities specific to their use in rheumatology quality measurement. We first explore other countries’ experiences collecting and evaluating national PRO data to assess quality of care. We describe the c...

  19. Term-equivalent functional brain maturational measures predict neurodevelopmental outcomes in premature infants.

    Science.gov (United States)

    El Ters, Nathalie M; Vesoulis, Zachary A; Liao, Steve M; Smyser, Christopher D; Mathur, Amit M

    2018-04-01

    Term equivalent age (TEA) brain MRI identifies preterm infants at risk for adverse neurodevelopmental outcomes. But some infants may experience neurodevelopmental impairments even in the absence of neuroimaging abnormalities. Evaluate the association of TEA amplitude-integrated EEG (aEEG) measures with neurodevelopmental outcomes at 24-36 months corrected age. We performed aEEG recordings and brain MRI at TEA (mean post-menstrual age of 39 (±2) weeks in a cohort of 60 preterm infants born at a mean gestational age of 26 (±2) weeks. Forty-four infants underwent Bayley Scales of Infant Development, 3rd Edition (BSID-III) testing at 24-36 months corrected age. Developmental delay was defined by a score greater than one standard deviation below the mean (neurodevelopmental outcomes was assessed using odds ratio, then adjusted for confounding variables using logistic regression. Infants with developmental delay in any domain had significantly lower values of SEF 90 . Absent cyclicity was more prevalent in infants with cognitive and motor delay. Both left and right SEF 90  neurodevelopmental outcomes. Therefore, a larger study is needed to validate these results in premature infants at low and high risk of brain injury. Copyright © 2018. Published by Elsevier B.V.

  20. Absence of Circadian Rhythms of Preterm Premature Rupture of Membranes and Preterm Placental Abruption

    Science.gov (United States)

    Luque-Fernandez, Miguel Angel; Ananth, Cande V.; Sanchez, Sixto E.; Qiu, Chun-fang; Hernandez-Diaz, Sonia; Valdimarsdottir, Unnur; Gelaye, Bizu; Williams, Michelle A.

    2014-01-01

    Purpose Data regarding circadian rhythm in the onset of spontaneous preterm premature rupture of membranes (PROM) and placental abruption (PA) cases are conflicting. We modeled the time of onset of preterm PROM and PA cases and examined if the circadian profiles varied based on the gestational age at delivery. Methods We used parametric and nonparametric methods, including trigonometric regression in the framework of generalized linear models, to test the presence of circadian rhythms in the time of onset of preterm PROM and PA cases, among 395 women who delivered a singleton between 2009 and 2010 in Lima, Peru. Results We found a diurnal circadian pattern, with a morning peak at 07h:32’ (95%CI:05h:46’ – 09h:18’) among moderate preterm PROM cases (P-value<0.001), and some evidence of a diurnal circadian periodicity among PA cases in term infants (P-value=0.067). However, we did not find evidence of circadian rhythms in the time of onset of extremely or very preterm PROM (P-value=0.259) and preterm PA (P-value=0.224). Conclusions The circadian rhythms of the time of onset of preterm PROM and PA cases varied based on gestational weeks at delivery. While circadian rhythms were presented among moderate preterm PROM and term PA cases, there was no evidence of circadian rhythms among preterm PA and very or extremely preterm PROM cases, underlying other mechanisms associated with the time of onset. PMID:25453346

  1. Methods for interpreting change over time in patient-reported outcome measures.

    Science.gov (United States)

    Wyrwich, K W; Norquist, J M; Lenderking, W R; Acaster, S

    2013-04-01

    Interpretation guidelines are needed for patient-reported outcome (PRO) measures' change scores to evaluate efficacy of an intervention and to communicate PRO results to regulators, patients, physicians, and providers. The 2009 Food and Drug Administration (FDA) Guidance for Industry Patient-Reported Outcomes (PRO) Measures: Use in Medical Product Development to Support Labeling Claims (hereafter referred to as the final FDA PRO Guidance) provides some recommendations for the interpretation of change in PRO scores as evidence of treatment efficacy. This article reviews the evolution of the methods and the terminology used to describe and aid in the communication of meaningful PRO change score thresholds. Anchor- and distribution-based methods have played important roles, and the FDA has recently stressed the importance of cross-sectional patient global assessments of concept as anchor-based methods for estimation of the responder definition, which describes an individual-level treatment benefit. The final FDA PRO Guidance proposes the cumulative distribution function (CDF) of responses as a useful method to depict the effect of treatments across the study population. While CDFs serve an important role, they should not be a replacement for the careful investigation of a PRO's relevant responder definition using anchor-based methods and providing stakeholders with a relevant threshold for the interpretation of change over time.

  2. Capsular Outcomes After Pediatric Cataract Surgery Without Intraocular Lens Implantation: Qualitative Classification and Quantitative Measurement.

    Science.gov (United States)

    Tan, Xuhua; Lin, Haotian; Lin, Zhuoling; Chen, Jingjing; Tang, Xiangchen; Luo, Lixia; Chen, Weirong; Liu, Yizhi

    2016-03-01

    The objective of this study was to investigate capsular outcomes 12 months after pediatric cataract surgery without intraocular lens implantation via qualitative classification and quantitative measurement.This study is a cross-sectional study that was approved by the institutional review board of Zhongshan Ophthalmic Center of Sun Yat-sen University in Guangzhou, China.Digital coaxial retro-illumination photographs of 329 aphakic pediatric eyes were obtained 12 months after pediatric cataract surgery without intraocular lens implantation. Capsule digital coaxial retro-illumination photographs were divided as follows: anterior capsule opening area (ACOA), posterior capsule opening area (PCOA), and posterior capsule opening opacity (PCOO). Capsular outcomes were qualitatively classified into 3 types based on the PCOO: Type I-capsule with mild opacification but no invasion into the capsule opening; Type II-capsule with moderate opacification accompanied by contraction of the ACOA and invasion to the occluding part of the PCOA; and Type III-capsule with severe opacification accompanied by total occlusion of the PCOA. Software was developed to quantitatively measure the ACOA, PCOA, and PCOO using standardized DCRPs. The relationships between the accurate intraoperative anterior and posterior capsulorhexis sizes and the qualitative capsular types were statistically analyzed.The DCRPs of 315 aphakic eyes (95.8%) of 191 children were included. Capsular outcomes were classified into 3 types: Type I-120 eyes (38.1%); Type II-157 eyes (49.8%); Type III-38 eyes (12.1%). The scores of the capsular outcomes were negatively correlated with intraoperative anterior capsulorhexis size (R = -0.572, P PCOA increased in size from Type I to Type II, and the PCOO increased from Type II to Type III (all P < 0.05).Capsular outcomes after pediatric cataract surgery can be qualitatively classified and quantitatively measured by acquisition, division, definition, and user

  3. Pretreatment organ function in patients with advanced head and neck cancer: clinical outcome measures and patients' views

    Directory of Open Access Journals (Sweden)

    Rasch Coen RN

    2009-11-01

    Full Text Available Abstract Background Aim of this study is to thoroughly assess pretreatment organ function in advanced head and neck cancer through various clinical outcome measures and patients' views. Methods A comprehensive, multidimensional assessment was used, that included quality of life, swallowing, mouth opening, and weight changes. Fifty-five patients with stage III-IV disease were entered in this study prior to organ preserving (chemoradiation treatment. Results All patients showed pretreatment abnormalities or problems, identified by one or more of the outcome measures. Most frequent problems concerned swallowing, pain, and weight loss. Interestingly, clinical outcome measures and patients' perception did no always concur. E.g. videofluoroscopy identified aspiration and laryngeal penetration in 18% of the patients, whereas only 7 patients (13% perceived this as problematic; only 2 out of 7 patients with objective trismus actually perceived trismus. Conclusion The assessment identified several problems already pre-treatment, in this patient population. A thorough assessment of both clinical measures and patients' views appears to be necessary to gain insight in all (perceived pre-existing functional and quality of life problems.

  4. Long-Term Survival Prediction for Coronary Artery Bypass Grafting: Validation of the ASCERT Model Compared With The Society of Thoracic Surgeons Predicted Risk of Mortality.

    Science.gov (United States)

    Lancaster, Timothy S; Schill, Matthew R; Greenberg, Jason W; Ruaengsri, Chawannuch; Schuessler, Richard B; Lawton, Jennifer S; Maniar, Hersh S; Pasque, Michael K; Moon, Marc R; Damiano, Ralph J; Melby, Spencer J

    2018-05-01

    The recently developed American College of Cardiology Foundation-Society of Thoracic Surgeons (STS) Collaboration on the Comparative Effectiveness of Revascularization Strategy (ASCERT) Long-Term Survival Probability Calculator is a valuable addition to existing short-term risk-prediction tools for cardiac surgical procedures but has yet to be externally validated. Institutional data of 654 patients aged 65 years or older undergoing isolated coronary artery bypass grafting between 2005 and 2010 were reviewed. Predicted survival probabilities were calculated using the ASCERT model. Survival data were collected using the Social Security Death Index and institutional medical records. Model calibration and discrimination were assessed for the overall sample and for risk-stratified subgroups based on (1) ASCERT 7-year survival probability and (2) the predicted risk of mortality (PROM) from the STS Short-Term Risk Calculator. Logistic regression analysis was performed to evaluate additional perioperative variables contributing to death. Overall survival was 92.1% (569 of 597) at 1 year and 50.5% (164 of 325) at 7 years. Calibration assessment found no significant differences between predicted and actual survival curves for the overall sample or for the risk-stratified subgroups, whether stratified by predicted 7-year survival or by PROM. Discriminative performance was comparable between the ASCERT and PROM models for 7-year survival prediction (p validated for prediction of long-term survival after coronary artery bypass grafting in all risk groups. The widely used STS PROM performed comparably as a predictor of long-term survival. Both tools provide important information for preoperative decision making and patient counseling about potential outcomes after coronary artery bypass grafting. Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  5. Validation of the CMT Pediatric Scale as an outcome measure of disability

    Science.gov (United States)

    Burns, Joshua; Ouvrier, Robert; Estilow, Tim; Shy, Rosemary; Laurá, Matilde; Pallant, Julie F.; Lek, Monkol; Muntoni, Francesco; Reilly, Mary M.; Pareyson, Davide; Acsadi, Gyula; Shy, Michael E.; Finkel, Richard S.

    2012-01-01

    Objective Charcot-Marie-Tooth disease (CMT) is a common heritable peripheral neuropathy. There is no treatment for any form of CMT although clinical trials are increasingly occurring. Patients usually develop symptoms during the first two decades of life but there are no established outcome measures of disease severity or response to treatment. We identified a set of items that represent a range of impairment levels and conducted a series of validation studies to build a patient-centered multi-item rating scale of disability for children with CMT. Methods As part of the Inherited Neuropathies Consortium, patients aged 3–20 years with a variety of CMT types were recruited from the USA, UK, Italy and Australia. Initial development stages involved: definition of the construct, item pool generation, peer review and pilot testing. Based on data from 172 patients, a series of validation studies were conducted, including: item and factor analysis, reliability testing, Rasch modeling and sensitivity analysis. Results Seven areas for measurement were identified (strength, dexterity, sensation, gait, balance, power, endurance), and a psychometrically robust 11-item scale constructed (Charcot-Marie-Tooth disease Pediatric Scale: CMTPedS). Rasch analysis supported the viability of the CMTPedS as a unidimensional measure of disability in children with CMT. It showed good overall model fit, no evidence of misfitting items, no person misfit and it was well targeted for children with CMT. Interpretation The CMTPedS is a well-tolerated outcome measure that can be completed in 25-minutes. It is a reliable, valid and sensitive global measure of disability for children with CMT from the age of 3 years. PMID:22522479

  6. Measurement properties of performance-based outcome measures to assess physical function in young and middle-aged people known to be at high risk of hip and/or knee osteoarthritis

    DEFF Research Database (Denmark)

    Kroman, S L; Roos, Ewa M.; Bennell, K L

    2014-01-01

    To systematically appraise the evidence on measurement properties of performance-based outcome measures to assess physical function in young and middle-aged people known to be at high risk of hip and/or knee osteoarthritis (OA).......To systematically appraise the evidence on measurement properties of performance-based outcome measures to assess physical function in young and middle-aged people known to be at high risk of hip and/or knee osteoarthritis (OA)....

  7. No difference in terms of radiostereometric analysis between fixed- and mobile-bearing total knee arthroplasty: a randomized, single-blind, controlled trial.

    Science.gov (United States)

    Schotanus, M G M; Pilot, P; Kaptein, B L; Draijer, W F; Tilman, P B J; Vos, R; Kort, N P

    2017-09-01

    A concern that arises with any new prosthesis is whether it will achieve satisfactory long-term implant stability. The gold standard of assessing the quality of fixation in a new or relatively new implant is to undertake a randomized controlled trial using radiostereometric analysis. It was hypothesized that both mobile-bearing total knee arthroplasty and fixed-bearing total knee arthroplasty have comparable migration patterns at 2-year follow-up. This study investigated two types of cemented total knee arthroplasty, the mobile- or fixed-bearing variant from the same family with use of radiostereometric analysis. This prospective, patient-blinded, randomized, controlled trial was designed to investigate early migration of the tibia component after two years of follow-up with use of radiostereometric analysis. A total of 50 patients were randomized to receive a mobile- or fixed-bearing TKA from the same family. Patients were evaluated during 2-year follow-up, including radiostereometric analysis, physical and clinical examination and patient reported outcome measures (PROMs). At two-year follow-up, the mean (±SD) maximum total point motion (MTPM) in the fixed-bearing group was 0.82 (±1.16) versus 0.92 mm (±0.64) in the mobile-bearing group (p = n.s) with the largest migration seen during the first 6 weeks (0.45 ± 0.32 vs. 0.54 ± 0.30). The clinical outcome and PROMs significantly improved within each group, not between both groups. Measuring early micromotion is useful for predicting clinical loosening that can lead to revision. The results of this study demonstrate that early migration of the mobile-bearing is similar to that of the fixed-bearing component at two years and was mainly seen in the first weeks after implantation. Randomized, single-blind, controlled trial, Level I.

  8. Choice of outcomes and measurement instruments in randomised trials on eLearning in medical education: a systematic mapping review protocol.

    Science.gov (United States)

    Law, Gloria C; Apfelbacher, Christian; Posadzki, Pawel P; Kemp, Sandra; Tudor Car, Lorainne

    2018-05-17

    There will be a lack of 18 million healthcare workers by 2030. Multiplying the number of well-trained healthcare workers through innovative ways such as eLearning is highly recommended in solving this shortage. However, high heterogeneity of learning outcomes in eLearning systematic reviews reveals a lack of consistency and agreement on core learning outcomes in eLearning for medical education. In addition, there seems to be a lack of validity evidence for measurement instruments used in these trials. This undermines the credibility of these outcome measures and affects the ability to draw accurate and meaningful conclusions. The aim of this research is to address this issue by determining the choice of outcomes, measurement instruments and the prevalence of measurement instruments with validity evidence in randomised trials on eLearning for pre-registration medical education. We will conduct a systematic mapping and review to identify the types of outcomes, the kinds of measurement instruments and the prevalence of validity evidence among measurement instruments in eLearning randomised controlled trials (RCTs) in pre-registration medical education. The search period will be from January 1990 until August 2017. We will consider studies on eLearning for health professionals' education. Two reviewers will extract and manage data independently from the included studies. Data will be analysed and synthesised according to the aim of the review. Appropriate choice of outcomes and measurement tools is essential for ensuring high-quality research in the field of eLearning and eHealth. The results of this study could have positive implications for other eHealth interventions, including (1) improving quality and credibility of eLearning research, (2) enhancing the quality of digital medical education and (3) informing researchers, academics and curriculum developers about the types of outcomes and validity evidence for measurement instruments used in eLearning studies. The

  9. Critical thinking as an educational outcome: an evaluation of current tools of measurement.

    Science.gov (United States)

    Adams, M H; Whitlow, J F; Stover, L M; Johnson, K W

    1996-01-01

    Critical thinking, an outcome criterion of the National League for Nursing and the Council of Baccalaureate and Higher Degree Programs, is an abstract skill difficult to measure. The authors provide a comprehensive review of four instruments designed to measure critical thinking and summarize research in which the tools were used. Analysis of this information will empower nursing faculty members to select a critical-thinking instrument that is individualized to the needs of their respective nursing programs.

  10. Evaluating test-retest reliability in patient-reported outcome measures for older people: A systematic review.

    Science.gov (United States)

    Park, Myung Sook; Kang, Kyung Ja; Jang, Sun Joo; Lee, Joo Yun; Chang, Sun Ju

    2018-03-01

    This study aimed to evaluate the components of test-retest reliability including time interval, sample size, and statistical methods used in patient-reported outcome measures in older people and to provide suggestions on the methodology for calculating test-retest reliability for patient-reported outcomes in older people. This was a systematic literature review. MEDLINE, Embase, CINAHL, and PsycINFO were searched from January 1, 2000 to August 10, 2017 by an information specialist. This systematic review was guided by both the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist and the guideline for systematic review published by the National Evidence-based Healthcare Collaborating Agency in Korea. The methodological quality was assessed by the Consensus-based Standards for the selection of health Measurement Instruments checklist box B. Ninety-five out of 12,641 studies were selected for the analysis. The median time interval for test-retest reliability was 14days, and the ratio of sample size for test-retest reliability to the number of items in each measure ranged from 1:1 to 1:4. The most frequently used statistical methods for continuous scores was intraclass correlation coefficients (ICCs). Among the 63 studies that used ICCs, 21 studies presented models for ICC calculations and 30 studies reported 95% confidence intervals of the ICCs. Additional analyses using 17 studies that reported a strong ICC (>0.09) showed that the mean time interval was 12.88days and the mean ratio of the number of items to sample size was 1:5.37. When researchers plan to assess the test-retest reliability of patient-reported outcome measures for older people, they need to consider an adequate time interval of approximately 13days and the sample size of about 5 times the number of items. Particularly, statistical methods should not only be selected based on the types of scores of the patient-reported outcome measures, but should also be described clearly in

  11. Mapping to Estimate Health-State Utility from Non-Preference-Based Outcome Measures: An ISPOR Good Practices for Outcomes Research Task Force Report.

    Science.gov (United States)

    Wailoo, Allan J; Hernandez-Alava, Monica; Manca, Andrea; Mejia, Aurelio; Ray, Joshua; Crawford, Bruce; Botteman, Marc; Busschbach, Jan

    2017-01-01

    Economic evaluation conducted in terms of cost per quality-adjusted life-year (QALY) provides information that decision makers find useful in many parts of the world. Ideally, clinical studies designed to assess the effectiveness of health technologies would include outcome measures that are directly linked to health utility to calculate QALYs. Often this does not happen, and even when it does, clinical studies may be insufficient for a cost-utility assessment. Mapping can solve this problem. It uses an additional data set to estimate the relationship between outcomes measured in clinical studies and health utility. This bridges the evidence gap between available evidence on the effect of a health technology in one metric and the requirement for decision makers to express it in a different one (QALYs). In 2014, ISPOR established a Good Practices for Outcome Research Task Force for mapping studies. This task force report provides recommendations to analysts undertaking mapping studies, those that use the results in cost-utility analysis, and those that need to critically review such studies. The recommendations cover all areas of mapping practice: the selection of data sets for the mapping estimation, model selection and performance assessment, reporting standards, and the use of results including the appropriate reflection of variability and uncertainty. This report is unique because it takes an international perspective, is comprehensive in its coverage of the aspects of mapping practice, and reflects the current state of the art. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  12. Annual Outcomes With Transcatheter Valve Therapy: From the STS/ACC TVT Registry.

    Science.gov (United States)

    Holmes, David R; Nishimura, Rick A; Grover, Frederick L; Brindis, Ralph G; Carroll, John D; Edwards, Fred H; Peterson, Eric D; Rumsfeld, John S; Shahian, David M; Thourani, Vinod H; Tuzcu, E Murat; Vemulapalli, Sreekanth; Hewitt, Kathleen; Michaels, Joan; Fitzgerald, Susan; Mack, Michael J

    2016-02-01

    The Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry has been a joint initiative of the STS and the ACC in concert with multiple stakeholders. The TVT Registry has important information regarding patient selection, delivery of care, science, education, and research in the field of structural valvular heart disease. This report provides an overview on current U.S. TVT practice and trends. The emphasis is on demographics, in-hospital procedural characteristics, and outcomes of patients having transcatheter aortic valve replacement (TAVR) performed at 348 U.S. centers. The TVT Registry captured 26,414 TAVR procedures as of December 31, 2014. Temporal trends between 2012 and 2013 versus 2014 were compared. Comparison of the 2 time periods reveals that TAVR patients remain elderly (mean age 82 years), with multiple comorbidities, reflected by a high mean STS predicted risk of mortality (STS PROM) for surgical valve replacement (8.34%), were highly symptomatic (New York Heart Association functional class III/IV in 82.5%), frail (slow 5-m walk test in 81.6%), and have poor self-reported health status (median baseline Kansas City Cardiomyopathy Questionnaire score of 39.1). Procedure performance is changing, with an increased use of moderate sedation (from 1.6% to 5.1%) and increase in femoral access using percutaneous techniques (66.8% in 2014). Vascular complication rates are decreasing (from 5.6% to 4.2%), whereas site-reported stroke rates remain stable at 2.2%. The TVT Registry provides important information on characteristics and outcomes of TAVR in contemporary U.S. clinical practice. It can be used to identify trends in practice and opportunities for quality improvement.

  13. Analysis of Traditional versus Three-Dimensional Augmented Curriculum on Anatomical Learning Outcome Measures

    Science.gov (United States)

    Peterson, Diana Coomes; Mlynarczyk, Gregory S.A.

    2016-01-01

    This study examined whether student learning outcome measures are influenced by the addition of three-dimensional and digital teaching tools to a traditional dissection and lecture learning format curricula. The study was performed in a semester long graduate level course that incorporated both gross anatomy and neuroanatomy curricula. Methods…

  14. The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials.

    Science.gov (United States)

    Schmitt, Jochen; Spuls, Phyllis I; Thomas, Kim S; Simpson, Eric; Furue, Masutaka; Deckert, Stefanie; Dohil, Magdalene; Apfelbacher, Christian; Singh, Jasvinder A; Chalmers, Joanne; Williams, Hywel C

    2014-10-01

    The lack of core outcome sets for atopic eczema (AE) is a major obstacle for advancing evidence-based treatment. The global Harmonising Outcome Measures for Eczema (HOME) initiative has already defined clinical signs, symptoms, quality of life, and long-term control of flares as core outcome domains for AE trials. This article deals with the standardization of measurement instruments to assess clinical signs of AE. To resolve the current lack of standardization of the assessment of clinical signs of AE, we followed a structured process of systematic reviews and international consensus sessions to identify 1 core outcome measurement instrument for assessment of clinical signs in all future AE trials. Systematic reviews indicated that from 16 different instruments identified to assess clinical signs of AE, only the Eczema Area and Severity Index (EASI) and the objective Scoring Atopic Dermatitis (SCORAD) index were identified as extensively validated. The EASI has adequate validity, responsiveness, internal consistency, and intraobserver reliability. The objective SCORAD index has adequate validity, responsiveness, and interobserver reliability but unclear intraobserver reliability to measure clinical signs of AE. In an international consensus study, patients, physicians, nurses, methodologists, and pharmaceutical industry representatives agreed that the EASI is the preferred core instrument to measure clinical signs in all future AE trials. All stakeholders involved in designing, reporting, and using clinical trials on AE are asked to comply with this consensus to enable better evidence-based decision making, clearer scientific communication, and improved patient care. Copyright © 2014 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

  15. Excursions out-of-lane versus standard deviation of lateral position as outcome measure of the on-the-road driving test

    NARCIS (Netherlands)

    Verster, Joris C; Roth, Thomas

    BACKGROUND: The traditional outcome measure of the Dutch on-the-road driving test is the standard deviation of lateral position (SDLP), the weaving of the car. This paper explores whether excursions out-of-lane are a suitable additional outcome measure to index driving impairment. METHODS: A

  16. Strategic B2B customer experience management: the importance of outcomes-based measures

    OpenAIRE

    Zolkiewski, Judy; Story, Victoria; Burton, Jamie; Chan, Paul; Gomes, Andre; Hunter-Jones, Philippa; O’Malley, Lisa; Peters, Linda D.; Raddats, Chris; Robinson, William

    2017-01-01

    Purpose\\ud \\ud The purpose of this paper is to critique the adequacy of efforts to capture the complexities of customer experience in a business-to-business (B2B) context using input–output measures. The paper introduces a strategic customer experience management framework to capture the complexity of B2B service interactions and discusses the value of outcomes-based measurement.\\ud Design/methodology/approach\\ud \\ud This is a theoretical paper that reviews extant literature related to B2B cu...

  17. Report from the fourth international consensus meeting to harmonize core outcome measures for atopic eczema/dermatitis clinical trials (HOME initiative)

    NARCIS (Netherlands)

    Chalmers, J. R.; Simpson, E.; Apfelbacher, C. J.; Thomas, K. S.; von Kobyletzki, L.; Schmitt, J.; Singh, J. A.; Svensson, A.; Williams, H. C.; Abuabara, K.; Aoki, V.; Ardeleanu, M.; Awici-Rasmussen, M.; Barbarot, S.; Berents, T. L.; Block, J.; Bragg, A.; Burton, T.; Clemmensen, K. K. Bjerring; Creswell-Melville, A.; Dinesen, M.; Drucker, A.; Eckert, L.; Flohr, C.; Garg, M.; Gerbens, L. A. A.; Graff, A. L. B.; Hanifin, J.; Heinl, D.; Humphreys, R.; Ishii, H. A.; Kataoka, Y.; Leshem, Y. A.; Marquort, B.; Massuel, M. -A.; Merhand, S.; Mizutani, H.; Murota, H.; Murrell, D. F.; Nakahara, T.; Nasr, I.; Nograles, K.; Ohya, Y.; Osterloh, I.; Pander, Jan; Prinsen, C.; Purkins, L.; Ridd, M.; Sach, T.; Schuttelaar, M. -L. A.; Shindo, S.; Smirnova, J.; Sulzer, A.; Gjerde, E. Synnove; Takaoka, R.; Talmo, H. Vestby; Tauber, M.; Torchet, F.; Volke, A.; Wahlgren, C. -F.; Weidinger, S.; Weisshaar, E.; Wollenberg, A.; Yamaga, K.; Zhao, C. Y.; Spuls, P. I.

    This article is a report of the fourth meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in Malmo, Sweden on 23-24 April 2015 (HOME IV). The aim of the meeting was to achieve consensus over the preferred outcome instruments for measuring patient-reported symptoms and

  18. The clinical and microbiological correlates of premature rupture of membranes

    Directory of Open Access Journals (Sweden)

    Karat C

    2006-01-01

    Full Text Available Prematurity is the cause of 85% of neonatal morbidity and mortality. Premature rupture of the membranes (PROM is associated with 30-40% of preterm deliveries. A case-control study conducted between July 2002 and 2003 examined the correlates and risk factors for PROM in Mysore, India. WBCs in vaginal fluid, leucocytes in urine, UTI and infection with E . coli , S . aureus , C. albicans and BV were significantly associated with PROM. BV, E. coli and WBCs in vaginal fluid were independent risk factors. Screening and treatment of BV and E. coli infection in pregnancy may reduce the risk of PROM.

  19. The clinical and microbiological correlates of premature rupture of membranes.

    Science.gov (United States)

    Karat, C; Madhivanan, P; Krupp, K; Poornima, S; Jayanthi, N V; Suguna, J S; Mathai, E

    2006-10-01

    Prematurity is the cause of 85% of neonatal morbidity and mortality. Premature rupture of the membranes (PROM) is associated with 30-40% of preterm deliveries. A case-control study conducted between July 2002 and 2003 examined the correlates and risk factors for PROM in Mysore, India. WBCs in vaginal fluid, leucocytes in urine, UTI and infection with E. coli, S. aureus, C. albicans and BV were significantly associated with PROM. BV, E. coli and WBCs in vaginal fluid were independent risk factors. Screening and treatment of BV and E. coli infection in pregnancy may reduce the risk of PROM.

  20. MANUAL FOR PROCESORIENTERET MUSIKTERAPI MED PERSONER MED BPD.

    Directory of Open Access Journals (Sweden)

    Niels Hannibal

    2010-12-01

    Full Text Available Denne artikel introducerer et musikterapeutisk behandlingskoncept kaldet: Procesorienteret Musikterapi (PROM. PROM er et forsøg på at formulere en principiel ramme for musikterapi i psykiatrien, som dels tager udgangspunkt i 17 års klinisk erfaring, dels stiler mod at være ”best practice”. PROM indeholder beskrivelser af manualens unikke, essentielle men ikke unikke, acceptable og ikke acceptable dele. Den unikke del af PROM skal kunne implementeres til alle målgrupper, mens de øvrige dele af manualen rettes til i forhold til en specifik målgruppe. Denne udgave af PROM er specifikt rettet i mod musikterapi for patienter med personlighedsforstyrrelser. Manualen indgår også som en del af et pilotprojekt, der har til formål at udvikle en protokol for et internationalt RCT projekt med samme målgruppe

  1. Beyond total treatment effects in randomised controlled trials: Baseline measurement of intermediate outcomes needed to reduce confounding in mediation investigations.

    Science.gov (United States)

    Landau, Sabine; Emsley, Richard; Dunn, Graham

    2018-06-01

    Random allocation avoids confounding bias when estimating the average treatment effect. For continuous outcomes measured at post-treatment as well as prior to randomisation (baseline), analyses based on (A) post-treatment outcome alone, (B) change scores over the treatment phase or (C) conditioning on baseline values (analysis of covariance) provide unbiased estimators of the average treatment effect. The decision to include baseline values of the clinical outcome in the analysis is based on precision arguments, with analysis of covariance known to be most precise. Investigators increasingly carry out explanatory analyses to decompose total treatment effects into components that are mediated by an intermediate continuous outcome and a non-mediated part. Traditional mediation analysis might be performed based on (A) post-treatment values of the intermediate and clinical outcomes alone, (B) respective change scores or (C) conditioning on baseline measures of both intermediate and clinical outcomes. Using causal diagrams and Monte Carlo simulation, we investigated the performance of the three competing mediation approaches. We considered a data generating model that included three possible confounding processes involving baseline variables: The first two processes modelled baseline measures of the clinical variable or the intermediate variable as common causes of post-treatment measures of these two variables. The third process allowed the two baseline variables themselves to be correlated due to past common causes. We compared the analysis models implied by the competing mediation approaches with this data generating model to hypothesise likely biases in estimators, and tested these in a simulation study. We applied the methods to a randomised trial of pragmatic rehabilitation in patients with chronic fatigue syndrome, which examined the role of limiting activities as a mediator. Estimates of causal mediation effects derived by approach (A) will be biased if one of

  2. The Oxford Participation and Activities Questionnaire: study protocol.

    Science.gov (United States)

    Morley, David; Dummett, Sarah; Kelly, Laura; Dawson, Jill; Fitzpatrick, Ray; Jenkinson, Crispin

    2013-01-01

    With an ageing population and increasing demands on health and social care services, there is growing importance attached to the management of long-term conditions, including maximizing the cost-effectiveness of treatments. In line with this, there is increasing emphasis on the need to keep people both active and participating in daily life. Consequently, it is essential that well developed and validated instruments that can meaningfully assess levels of participation and activity are widely available. Current measures, however, are largely focused on disability and rehabilitation, and there is no measure of activity or participation for generic use that fully meets the standards set by regulatory bodies such as the US Food and Drug Administration. Here we detail a protocol for the development and validation of a new patient-reported outcome measure (PROM) for assessment of participation and activity in people experiencing a variety of health conditions, ie, the Oxford Participation and Activities Questionnaire (Ox-PAQ). The stages incorporated in its development are entirely in line with current regulations and represent best practice in the development of PROMs. Development of the Ox-PAQ is theoretically grounded in the World Health Organization International Classification of Functioning, Disability, and Health. The project incorporates a new strategy of engaging with stakeholders from the outset in an attempt to identify those characteristics of PROMs considered most important to a range of potential users. Items will be generated through interviews with patients from a range of conditions. Pretesting of the instrument will be via cognitive interviews and focus groups. A postal survey will be conducted, with data subject to factor and Rasch analysis in order to identify appropriate dimensions and redundant items. Reliability will be assessed by Cronbach's alpha and item-total correlations. A second, large-scale postal survey will follow, with the Ox-PAQ being

  3. Objective versus subjective outcome measures of biofeedback: what really matters?

    Science.gov (United States)

    Berry, Amanda; Rudick, Kristen; Richter, Meg; Zderic, Stephen

    2014-08-01

    Clinical epidemiologic studies suggest that once established, voiding dysfunction can become a lifelong condition if not treated correctly early on in life. Biofeedback is one component of a voiding retraining program to help children with voiding dysfunction. Our goal was to compare objective non-invasive urodynamic data obtained during office biofeedback sessions with patient reported voiding symptom scores. Charts of 55 children referred in 2010 for pelvic floor muscle biofeedback therapy for urinary incontinence were retrospectively reviewed. Patients with any anatomic diagnoses were excluded. Forty-seven (86%) females and eight males (14%) with a mean age of 8.2 years made up the cohort. Uroflow curves, voided volumes, and post-void residuals were recorded at each visit and served as objective data. Volumes were normalized as a percentage of expected bladder capacity according to age. The patient reported symptom score and patient reported outcome (improved, no change or worse) served as subjective measures of intervention. The primary referral diagnoses were day and night wetting in 37 (67%) and daytime incontinence in 18 (33%) children. A history of urinary tract infection (UTI) was noted in 32 (64%) patients, and 25% were maintained on antibiotic prophylaxis during the study period. Twenty-nine percent were maintained on anticholinergic medication. Patients attended an average of 2.5 biofeedback sessions. Voided volumes and post void residual volumes were unchanged, 50% of the abnormal uroflow curves normalized over the course of treatment (p biofeedback were rated an improved in 26 (47%), no change in 15 (27%), worse in three (5%) patients, and not rated in 11 patients (21%). Pelvic floor muscle biofeedback is associated with patient-reported improvement in symptoms, reduction in voiding symptom score, and normalization of uroflow curves, but these improvements are not correlated with objective parameters of voided volumes and post-void residual urine

  4. Report from the fourth international consensus meeting to harmonize core outcome measures for atopic eczema/dermatitis clinical trials (HOME initiative)

    NARCIS (Netherlands)

    Chalmers, J. R.; Simpson, E.; Apfelbacher, C. J.; Thomas, K. S.; von Kobyletzki, L.; Schmitt, J.; Singh, J. A.; Svensson, Å; Williams, H. C.; Abuabara, K.; Aoki, V.; Ardeleanu, M.; Awici-Rasmussen, M.; Barbarot, S.; Berents, T. L.; Block, J.; Bragg, A.; Burton, T.; Bjerring Clemmensen, K. K.; Creswell-Melville, A.; Dinesen, M.; Drucker, A.; Eckert, L.; Flohr, C.; Garg, M.; Gerbens, L. A. A.; Graff, A. L. B.; Hanifin, J.; Heinl, D.; Humphreys, R.; Ishii, H. A.; Kataoka, Y.; Leshem, Y. A.; Marquort, B.; Massuel, M.-A.; Merhand, S.; Mizutani, H.; Murota, H.; Murrell, D. F.; Nakahara, T.; Nasr, I.; Nograles, K.; Ohya, Y.; Osterloh, I.; Pander, J.; Prinsen, C.; Purkins, L.; Ridd, M.; Sach, T.; Schuttelaar, M.-L. A.; Shindo, S.; Smirnova, J.; Sulzer, A.; Synnøve Gjerde, E.; Takaoka, R.; Vestby Talmo, H.; Tauber, M.; Torchet, F.; Volke, A.; Wahlgren, C.-F.; Weidinger, S.; Weisshaar, E.; Wollenberg, A.; Yamaga, K.; Zhao, C. Y.; Spuls, P. I.

    2016-01-01

    This article is a report of the fourth meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in Malmö, Sweden on 23-24 April 2015 (HOME IV). The aim of the meeting was to achieve consensus over the preferred outcome instruments for measuring patient-reported symptoms and

  5. Outcomes of total knee arthroplasty in relation to preoperative patient-reported and radiographic measures: data from the osteoarthritis initiative.

    Science.gov (United States)

    Kahn, Timothy L; Soheili, Aydin; Schwarzkopf, Ran

    2013-12-01

    Total knee arthroplasty (TKA) is the preferred surgical treatment for end-stage osteoarthritis. However, substantial numbers of patients still experience poor outcomes. Consequently, it is important to identify which patient characteristics are predictive of outcomes in order to guide clinical decisions. Our hypothesis is that preoperative patient-reported outcome measures and radiographic measures may help to predict TKA outcomes. Using cohort data from the Osteoarthritis Initiative, we studied 172 patients who underwent TKA. For each patient, we compiled pre- and postoperative Western Ontario and McMaster University Arthritis Index (WOMAC) scores. Radiographs were measured for knee joint angles, femorotibial angles, anatomical lateral distal femoral angles, and anatomical medial proximal tibial angles; Kellgren and Lawrence (KL) grades were assigned to each compartment of the knee. All studied measurements were compared to WOMAC outcomes. Preoperative WOMAC disability, pain, and total scores were positively associated with postoperative WOMAC total scores (P = .010, P = .010, and P = .009, respectively) and were associated with improvement in WOMAC total scores (P < .001, P < .001, and P < .001, respectively). For radiographic measurements, preoperative joint angles were positively associated with improvements in postoperative WOMAC total scores (P = .044). Combined KL grades (medial and lateral compartments) were negatively correlated with postoperative WOMAC disability and pain scores (P = .045 and P = .044) and were positively correlated with improvements in WOMAC total scores (P = .001). All preoperative WOMAC scores demonstrated positive associations with postoperative WOMAC scores, while among the preoperative radiographic measurements only combined KL grades and joint angles showed any correlation with postoperative WOMAC scores. Higher preoperative KL grades and joint angles were associated with better (lower) postoperative WOMAC scores, demonstrating an

  6. Comparing contents of outcome measures in cerebral palsy using the International Classification of Functioning (ICF-CY): a systematic review.

    Science.gov (United States)

    Schiariti, Veronica; Klassen, Anne F; Cieza, Alarcos; Sauve, Karen; O'Donnell, Maureen; Armstrong, Robert; Mâsse, Louise C

    2014-01-01

    The International Classification of Functioning children and youth version (ICF-CY) provides a universal framework for defining and classifying functioning and disability in children worldwide. To facilitate the application of the ICF in practice, ICF based-tools like the "ICF Core Sets" are being developed. In the context of the development of the ICF-CY Core Sets for children with Cerebral Palsy (CP), the aims of this study were as follows: to identify and compare the content of outcome measures used in studies of children with CP using the ICF-CY coding system; and to describe the most frequently addressed areas of functioning in those studies. We searched multiple databases likely to capture studies involving children with CP from January 1998 to March 2012. We included all English language articles that studied children aged 2-18 years and described an interventional or observational study. Constructs of the outcome measures identified in studies were linked to the ICF-CY by two trained professionals. We found 231 articles that described 238 outcome measures. The outcome measures contained 2193 concepts that were linked to the ICF-CY and covered 161 independent ICF-CY categories. Out of the 161 categories, 53 (33.5%) were related to body functions, 75 (46%) were related to activities/participation, 26 (16.1%) were related to environmental factors, and 7 (4.3%) were related to body structures. This systematic review provides information about content of measures that may guide researchers and clinicians in their selection of an outcome measure for use in a study and/or clinical practice with children with CP. Copyright © 2013 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.

  7. Report from the fourth international consensus meeting to harmonize core outcome measures for atopic eczema/dermatitis clinical trials (HOME initiative)

    OpenAIRE

    Chalmers, J.R.; Simpson, E.; Apfelbacher, C.J.; Thomas, K.S.; von Kobyletzki, L.; Schmitt, J.; Singh, J.A.; Svensson, Å.; Williams, H.C.; Abuabara, K.; Aoki, V.; Ardeleanu, M.; Awici-Rasmussen, M.; Barbarot, S.; Berents, T.L.

    2016-01-01

    This article is a report of the fourth meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in Malmö, Sweden on 23–24 April 2015 (HOME IV). The aim of the meeting was to achieve consensus over the preferred outcome instruments for measuring patient-reported symptoms and quality of life for the HOME core outcome set for atopic eczema (AE). Following presentations, which included data from systematic reviews, consensus discussions were held in a mixture of whole group a...

  8. Varying the item format improved the range of measurement in patient-reported outcome measures assessing physical function.

    Science.gov (United States)

    Liegl, Gregor; Gandek, Barbara; Fischer, H Felix; Bjorner, Jakob B; Ware, John E; Rose, Matthias; Fries, James F; Nolte, Sandra

    2017-03-21

    Physical function (PF) is a core patient-reported outcome domain in clinical trials in rheumatic diseases. Frequently used PF measures have ceiling effects, leading to large sample size requirements and low sensitivity to change. In most of these instruments, the response category that indicates the highest PF level is the statement that one is able to perform a given physical activity without any limitations or difficulty. This study investigates whether using an item format with an extended response scale, allowing respondents to state that the performance of an activity is easy or very easy, increases the range of precise measurement of self-reported PF. Three five-item PF short forms were constructed from the Patient-Reported Outcomes Measurement Information System (PROMIS®) wave 1 data. All forms included the same physical activities but varied in item stem and response scale: format A ("Are you able to …"; "without any difficulty"/"unable to do"); format B ("Does your health now limit you …"; "not at all"/"cannot do"); format C ("How difficult is it for you to …"; "very easy"/"impossible"). Each short-form item was answered by 2217-2835 subjects. We evaluated unidimensionality and estimated a graded response model for the 15 short-form items and remaining 119 items of the PROMIS PF bank to compare item and test information for the short forms along the PF continuum. We then used simulated data for five groups with different PF levels to illustrate differences in scoring precision between the short forms using different item formats. Sufficient unidimensionality of all short-form items and the original PF item bank was supported. Compared to formats A and B, format C increased the range of reliable measurement by about 0.5 standard deviations on the positive side of the PF continuum of the sample, provided more item information, and was more useful in distinguishing known groups with above-average functioning. Using an item format with an extended

  9. Outcome measures used in clinical studies on neonatal brachial plexus palsy: A systematic literature review using the International Classification of Functioning, Disability and Health.

    Science.gov (United States)

    Sarac, Cigdem; Duijnisveld, Bouke J; van der Weide, Amber; Schoones, Jan W; Malessy, Martijn J A; Nelissen, Rob G H H; Vlieland, Thea P M Vliet

    2015-01-01

    Symptoms of a neonatal brachial plexus palsy (NBPP) can vary widely among individuals and numerous clinical studies have been performed to identify the natural history and to improve treatment. The aim of this study was to identify and describe all outcome measures used in clinical studies on patients with an NBPP and categorize these outcome measures according to the International Classification of Functioning, Disability and Health (ICF). Electronic searches of different databases were carried out. All clinical studies describing one or more outcomes of NBPP were selected. Data on outcome measures was systematically extracted and the contents were analyzed and linked to the ICF. A total of 217 full texts were selected and 59 different outcome measures were identified. The 5 most frequently used outcome measures included range of motion of the shoulder (n= 166 studies, 76%), range of motion of the elbow (n= 87 studies, 40%), the Mallet scale (n= 66 studies, 30%), Magnetic Resonance Imaging (n= 37 studies, 17%) and the Medical Research Council motor grading scale (n= 31 studies, 14%). Assessments related to Body functions and Structures were most frequent, whereas assessments associated with Activities and Participation and Environmental Factors were relatively uncommon. There was a high variability among the outcome measures used, with measures within the ICF component Body Functions being most common. These results underscore the need for the development and usage of outcome measures representing all domains of health status in patients with NBPP.

  10. Training clinicians in how to use patient-reported outcome measures in routine clinical practice

    NARCIS (Netherlands)

    Santana, Maria J.; Haverman, Lotte; Absolom, Kate; Takeuchi, Elena; Feeny, David; Grootenhuis, Martha; Velikova, Galina

    2015-01-01

    Patient-reported outcome measures (PROs) were originally developed for comparing groups of people in clinical trials and population studies, and the results were used to support treatment recommendations or inform health policy, but there was not direct benefit for the participants providing PROs

  11. The Benchmarking Capacity of a General Outcome Measure of Academic Language in Science and Social Studies

    Science.gov (United States)

    Mooney, Paul; Lastrapes, Renée E.

    2016-01-01

    The amount of research evaluating the technical merits of general outcome measures of science and social studies achievement is growing. This study targeted criterion validity for critical content monitoring. Questions addressed the concurrent criterion validity of alternate presentation formats of critical content monitoring and the measure's…

  12. Preoperative cow-side lactatemia measurement predicts negative outcome in Holstein dairy cattle with right abomasal disorders.

    Science.gov (United States)

    Boulay, G; Francoz, D; Doré, E; Dufour, S; Veillette, M; Badillo, M; Bélanger, A-M; Buczinski, S

    2014-01-01

    The objectives of the current study were (1) to determine the gain in prognostic accuracy of preoperative l-lactate concentration (LAC) measured on farm on cows with right displaced abomasum (RDA) or abomasal volvulus (AV) for predicting negative outcome; and (2) to suggest clinically relevant thresholds for such use. A cohort of 102 cows with on-farm surgical diagnostic of RDA or AV was obtained from June 2009 through December 2011. Blood was drawn from coccygeal vessels before surgery and plasma LAC was immediately measured by using a portable clinical analyzer. Dairy producers were interviewed by phone 30 d following surgery and the outcome was determined: a positive outcome if the owner was satisfied of the overall evolution 30 d postoperatively, and a negative outcome if the cow was culled, died, or if the owner reported being unsatisfied 30 d postoperatively. The area under the curve of the receiver operating characteristic curve for LAC was 0.92 and was significantly greater than the area under the curve of the receiver operating characteristic curve of heart rate (HR; 0.77), indicating that LAC, in general, performed better than HR to predict a negative outcome. Furthermore, the ability to predict a negative outcome was significantly improved when LAC measurement was considered in addition to the already available HR data (area under the curve: 0.93 and 95% confidence interval: 0.87, 0.99). Important inflection points of the misclassification cost term function were noted at thresholds of 2 and 6 mmol/L, suggesting the potential utility of these cut-points. The 2 and 6 mmol/L thresholds had a sensitivity, specificity, positive predictive value, and negative predictive value for predicting a negative outcome of 76.2, 82.7, 53.3, and 93.1%, and of 28.6, 97.5, 75, and 84%, respectively. In terms of clinical interpretation, LAC ≤2 mmol/L appeared to be a good indicator of positive outcome and could be used to support a surgical treatment decision. The

  13. Improvement in patient–reported outcomes after group poetry therapy of women with breast cancer

    Directory of Open Access Journals (Sweden)

    Mohammad Ali Gozashti

    2017-07-01

    Full Text Available Background: One of the best ways of achieving the patients’ views and expectations about the effects of a therapeutic or palliative intervention on their quality of life is using PatientReported Outcome Measures (PROMs. Poetry therapy as a psychotherapy intervention has been used for palliation of stressful conditions of several chronic diseases and disabilities. In the present study, we aimed to evaluate the effectiveness of group poetry therapy on the quality of life measures in women with breast cancer.Methods: A total of 30 women with breast cancer, undergoing chemotherapy at a referral center in the north of Iran, participated in the current quasi-experimental before-after study conducted in 2016. The study protocol included eight weekly sessions of group poetry therapy using poems from the great Persian poets. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30 was completed by the patients before beginning group poetry therapy and, twice more, one week and two months after the last session. Items of the questionnaire were manually scored and then analyzed using appropriate statistical tests in IBM SPSS Statistics for Windows, Version 21.0. Armonk, NY: IBM Corp.Results: A total of 28 patients participated in all the group poetry therapy sessions and completed the questionnaire. The mean and standard deviation of age were 45±66. The changes in the score of quality of life from 51.8 to 65.5 and 69 were observed to be significant in the one-week and two-month follow ups (both with P=0.002. Also, changes in symptom score from 34.5 to 23.7 (P=0.01 and functional score from 65.6 to 77.2 (P=0.01 in the two-month follow up were found to be statistically significant.Conclusion: Based on the findings of the study, it can be concluded that group poetry therapy, as a psychotherapy approach, can be used to improve quality of life in breast cancer patients.

  14. Accreditation of Medical Education Programs: Moving From Student Outcomes to Continuous Quality Improvement Measures.

    Science.gov (United States)

    Blouin, Danielle; Tekian, Ara

    2018-03-01

    Accreditation of undergraduate medical education programs aims to ensure the quality of medical education and promote quality improvement, with the ultimate goal of providing optimal patient care. Direct linkages between accreditation and education quality are, however, difficult to establish. The literature examining the impact of accreditation predominantly focuses on student outcomes, such as performances on national examinations. However, student outcomes present challenges with regard to data availability, comparability, and contamination.The true impact of accreditation may well rest in its ability to promote continuous quality improvement (CQI) within medical education programs. The conceptual model grounding this paper suggests accreditation leads medical schools to commit resources to and engage in self-assessment activities that represent best practices of CQI, leading to the development within schools of a culture of CQI. In line with this model, measures of the impact of accreditation on medical schools need to include CQI-related markers. The CQI orientation of organizations can be measured using validated instruments from the business and management fields. Repeated determinations of medical schools' CQI orientation at various points throughout their accreditation cycles could provide additional evidence of the impact of accreditation on medical education. Strong CQI orientation should lead to high-quality medical education and would serve as a proxy marker for the quality of graduates and possibly for the quality of care they provide.It is time to move away from a focus on student outcomes as measures of the impact of accreditation and embrace additional markers, such as indicators of organizational CQI orientation.

  15. Test-Retest Reliability of Dual-Task Outcome Measures in People With Parkinson Disease.

    Science.gov (United States)

    Strouwen, Carolien; Molenaar, Esther A L M; Keus, Samyra H J; Münks, Liesbeth; Bloem, Bastiaan R; Nieuwboer, Alice

    2016-08-01

    Dual-task (DT) training is gaining ground as a physical therapy intervention in people with Parkinson disease (PD). Future studies evaluating the effect of such interventions need reliable outcome measures. To date, the test-retest reliability of DT measures in patients with PD remains largely unknown. The purpose of this study was to assess the reliability of DT outcome measures in patients with PD. A repeated-measures design was used. Patients with PD ("on" medication, Mini-Mental State Examination score ≥24) performed 2 cognitive tasks (ie, backward digit span task and auditory Stroop task) and 1 functional task (ie, mobile phone task) in combination with walking. Tasks were assessed at 2 time points (same hour) with an interval of 6 weeks. Test-retest reliability was assessed for gait while performing each secondary task (DT gait) for both cognitive tasks while walking (DT cognitive) and for the functional task while walking (DT functional). Sixty-two patients with PD (age=39-89 years, Hoehn and Yahr stages II-III) were included in the study. Intraclass correlation coefficients (ICCs) showed excellent reliability for DT gait measures, ranging between .86 and .95 when combined with the digit span task, between .86 and .95 when combined with the auditory Stroop task, and between .72 and .90 when combined with the mobile phone task. The standard error of measurements for DT gait speed varied between 0.06 and 0.08 m/s, leading to minimal detectable changes between 0.16 and 0.22 m/s. With regard to DT cognitive measures, reaction times showed good-to-excellent reliability (digit span task: ICC=.75; auditory Stroop task: ICC=.82). The results cannot be generalized to patients with advanced disease or to other DT measures. In people with PD, DT measures proved to be reliable for use in clinical studies and look promising for use in clinical practice to assess improvements after DT training. Large effects, however, are needed to obtain meaningful effect sizes.

  16. Measuring Outcomes in Adult Weight Loss Studies That Include Diet and Physical Activity: A Systematic Review

    Directory of Open Access Journals (Sweden)

    Rachel A. Millstein

    2014-01-01

    Full Text Available Background. Measuring success of obesity interventions is critical. Several methods measure weight loss outcomes but there is no consensus on best practices. This systematic review evaluates relevant outcomes (weight loss, BMI, % body fat, and fat mass to determine which might be the best indicator(s of success. Methods. Eligible articles described adult weight loss interventions that included diet and physical activity and a measure of weight or BMI change and body composition change. Results. 28 full-text articles met inclusion criteria. Subjects, settings, intervention lengths, and intensities varied. All studies measured body weight (−2.9 to −17.3 kg, 9 studies measured BMI (−1.1 to −5.1 kg/m2, 20 studies measured % body fat (−0.7 to −10.2%, and 22 studies measured fat mass (−0.9 to −14.9 kg. All studies found agreement between weight or BMI and body fat mass or body fat % decreases, though there were discrepancies in degree of significance between measures. Conclusions. Nearly all weight or BMI and body composition measures agreed. Since body fat is the most metabolically harmful tissue type, it may be a more meaningful measure of health change. Future studies should consider primarily measuring % body fat, rather than or in addition to weight or BMI.

  17. The perceived personal control (PPC) questionnaire: reliability and validity in a sample from the United Kingdom.

    Science.gov (United States)

    McAllister, Marion; Wood, Alex M; Dunn, Graham; Shiloh, Shoshana; Todd, Chris

    2012-02-01

    Outcome measures are important assessment tools to evaluate clinical genetics services. Research suggests that perceived personal control (PPC) is an outcome valued by clinical genetics patients and clinicians. The PPC scale was developed in Hebrew to capture three dimensions of PPC: Cognitive, decisional, and behavioral control. This article reports on the first psychometric validation of the English translation of the PPC scale. Previous research has shown that the Hebrew and Dutch translations have good psychometric properties. However, the psychometric properties of the English translation have not been tested, and there is disagreement about the factor structure, with implications for how to score the measure. A total of 395 patients attending a clinical genetics appointment in the United Kingdom completed several measures at baseline, and a further 241 also completed measures at 2-4 weeks follow-up. The English language PPC has (a) a one-factor structure, (b) convergent validity with internal health locus of control (IHLC), satisfaction with life (SWL), depression, and authenticity, (c) high internal consistency (α = 0.83), and (d) sensitivity to change, being able to identify moderate changes in PPC following clinic attendance (Cohen's d = 0.40). These properties suggest the English language PPC measure is a useful tool for both clinical genetics research and for use as a Patient Reported Outcome Measure (PROM) in service evaluation. Copyright © 2011 Wiley Periodicals, Inc.

  18. Evaluating the use of gas discharge visualization to measure massage therapy outcomes

    Science.gov (United States)

    Haun, Jolie; Patel, Nitin; Schwartz, Gary; Ritenbaugh, Cheryl

    2017-01-01

    Background The purpose of this study was to evaluate the short-term effects of massage therapy using gas discharge visualization (GDV), a computerized biophysical electrophoton capture (EPC), in tandem with traditional self-report measures to evaluate the use of GDV measurement to assess the bioenergetic whole-person effects of massage therapy. Methods This study used a single treatment group, pre–post-repeated measures design with a sample of 23 healthy adults. This study utilized a single 50-min full-body relaxation massage with participants. GDV measurement method, an EPC, and traditional paper-based measures evaluating pain, stress, muscle tension, and well-being were used to assess intervention outcomes. Results Significant differences were found between pre- and post-measures of well-being, pain, stress, muscle tension, and GDV parameters. Pearson correlations indicate the GDV measure is correlated with pain and stress, variables that impact the whole person. Conclusions This study demonstrates that GDV parameters may be used to indicate significant bioenergetic change from pre- to post-massage. Findings warrant further investigation with a larger diverse sample size and control group to further explore GDV as a measure of whole-person bioenergetic effects associated with massage. PMID:26087069

  19. [Psychometric properties of Q-DIO, an instrument to measure the quality of documented nursing diagnoses, interventions and outcomes].

    NARCIS (Netherlands)

    Muller-Staub, M.; Lunney, M.; Lavin, M.A.; Needham, I.; Odenbreit, M.; Achterberg, T. van

    2010-01-01

    The instrument Q-DIO was developed in the years 2005 till 2006 to measure the quality of documented nursing diagnoses, interventions, and nursing sensitive patient outcomes. Testing psychometric properties of the Q-DIO (Quality of nursing Diagnoses, Interventions and Outcomes.) was the study aim.

  20. Health-related quality-of-life outcome measures in paediatric palliative care: A systematic review of psychometric properties and feasibility of use

    Science.gov (United States)

    Coombes, Lucy H; Wiseman, Theresa; Lucas, Grace; Sangha, Amrit; Murtagh, Fliss EM

    2016-01-01

    Background: The number of children worldwide requiring palliative care services is increasing due to advances in medical care and technology. The use of outcome measures is important to improve the quality and effectiveness of care. Aim: To systematically identify health-related quality-of-life outcome measures that could be used in paediatric palliative care and examine their feasibility of use and psychometric properties. Design: A systematic literature review and analysis of psychometric properties. Data sources: PsychInfo, Medline and EMBASE were searched from 1 January 1990 to 10 December 2014. Hand searches of the reference list of included studies and relevant reviews were also performed. Results: From 3460 articles, 125 papers were selected for full-text assessment. A total of 41 articles met the eligibility criteria and examined the psychometric properties of 22 health-related quality-of-life measures. Evidence was limited as at least half of the information on psychometric properties per instrument was missing. Measurement error was not analysed in any of the included articles and responsiveness was only analysed in one study. The methodological quality of included studies varied greatly. Conclusion: There is currently no ‘ideal’ outcome assessment measure for use in paediatric palliative care. The domains of generic health-related quality-of-life measures are not relevant to all children receiving palliative care and some domains within disease-specific measures are only relevant for that specific population. Potential solutions include adapting an existing measure or developing more individualized patient-centred outcome and experience measures. Either way, it is important to continue work on outcome measurement in this field. PMID:27247087