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Sample records for patient-reported pregnancy outcome

  1. Patient-Reported Disease Activity and Adverse Pregnancy Outcomes in Systemic Lupus Erythematosus and Rheumatoid Arthritis.

    Science.gov (United States)

    Harris, Nathaniel; Eudy, Amanda; Clowse, Megan

    2018-06-15

    While increased rheumatic disease activity during pregnancy has been associated with adverse pregnancy outcomes, this activity is typically assessed by the physician. Little is known, however, about the association between patient-reported measures of disease activity and pregnancy outcomes. Univariate and multivariable regression models were used to assess the relationship between patient and physician-reported measures of disease activity and adverse pregnancy outcomes in 225 patients with lupus or rheumatoid arthritis (RA) enrolled in a prospective registry at a single academic center from 2008-2016. In women with RA, patient-reported disease activity is associated with preterm birth (OR 5.9 (1.5-23.9)), and gestational age (beta -1.5 weeks (-2.6, -0.4 weeks)). The physician assessment of disease activity also predicted preterm (OR 2.1 (1.2-3.5)), small for gestational age births (OR 1.8 (1.03-3.1), and gestational age in weeks (beta -0.6 weeks (-0.9, -0.02 weeks)). On the other hand, SLE patient-reported disease activity measures, including the HAQ, pain or global health measures, are not associated with adverse pregnancy outcomes. However, physician measures of SLE disease activity are associated with preterm birth (OR 2.9 (1.-6.3)), cesarean delivery (OR 2.3 (1.0-5.3)), and preeclampsia (OR 2.8 (1.3-6.3)). The results do not appear to be driven by lupus nephritis or antiphospholipid syndrome. For women with RA, patient-reported measures of disease activity may be useful adjuncts to physician-reported measures in identifying pregnancies at greater risk. In contrast, in SLE, no patient-reported measures were associated with adverse outcomes while physician measures of disease activity helped predict several adverse pregnancy outcomes. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  2. 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....

  3. Development of a patient-reported outcome

    DEFF Research Database (Denmark)

    Juul, Tina; Søgaard, Karen; Roos, Ewa M.

    2015-01-01

    removed from the original 69. A multidimensional questionnaire, divided into five subscales, was developed from the remaining 34 items: mobility; symptoms; sleep disturbance; everyday activity and pain; and participation in everyday life. Exploratory factor analysis supported a 5-subscale structure......OBJECTIVE: To develop a patient-reported outcome evaluating the impact of neck pain. The results of item generation and reduction and subscale structure in support of the content and construct validity of the measure are reported. METHODS: Items were generated from the literature and through focus...

  4. Patient-reported Outcomes in Cystic Fibrosis

    OpenAIRE

    Goss, Christopher H.; Quittner, Alexandra L.

    2007-01-01

    Over the past 20 years, there has been tremendous progress in the area of patient-reported outcomes (PROs). A PRO instrument is defined as any measure of a patient's health status that is elicited directly from the patient and assesses how the patient “feels or functions with respect to his or her health condition.” The advances seen in clinical research regarding PROs has been mirrored in research in cystic fibrosis (CF). A large number of instruments have been used for both therapeutic and ...

  5. Patient reported outcomes in hip arthroplasty registries.

    Science.gov (United States)

    Paulsen, Aksel

    2014-05-01

    -retest). I found that the translated PRO had good feasibility, an excellent response rate, no floor effect, but a high ceiling effect (as was expected with our postoperative patients) and few patients missed too many items to calculate a sum score. The translated PRO had high test-retest reliability and very high internal consistency, and appears to be a valid and reliable tool for outcome studies on THA patients in a hip registry setting. The MCII and PASS study included 1,335 patients, and I estimated that one year after THA, an improvement of 38-55% from mean baseline PRO score and absolute follow-up scores of 57-91% of the maximum score correspond to a minimal important improvement and acceptable symptom state, respectively.

  6. Patient reported outcomes: looking beyond the label claim

    Directory of Open Access Journals (Sweden)

    Doward Lynda C

    2010-08-01

    Full Text Available Abstract The use of patient reported outcome scales in clinical trials conducted by the pharmaceutical industry has become more widespread in recent years. The use of such outcomes is particularly common for products developed to treat chronic, disabling conditions where the intention is not to cure but to ameliorate symptoms, facilitate functioning or, ultimately, to improve quality of life. In such cases, patient reported evidence is increasingly viewed as an essential complement to traditional clinical evidence for establishing a product's competitive advantage in the marketplace. In a commercial setting, the value of patient reported outcomes is viewed largely in terms of their potential for securing a labelling claim in the USA or inclusion in the summary of product characteristics in Europe. Although, the publication of the recent US Food and Drug Administration guidance makes it difficult for companies to make claims in the USA beyond symptom improvements, the value of these outcomes goes beyond satisfying requirements for a label claim. The European regulatory authorities, payers both in the US and Europe, clinicians and patients all play a part in determining both the availability and the pricing of medicinal products and all have an interest in patient-reported data that go beyond just symptoms. The purpose of the current paper is to highlight the potential added value of patient reported outcome data currently collected and held by the industry for these groups.

  7. 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

  8. Outcome of teenage pregnancy.

    Directory of Open Access Journals (Sweden)

    Bhalerao A

    1990-07-01

    Full Text Available Two hundred consecutive cases up to 19 years of age admitted for confinement at The Nowrosjee Wadia Maternity Hospital, Bombay, were studied. Out of these 200 girls, 6 were unmarried, 51 were anaemic, 20 had toxaemia of pregnancy. Six girls (43% in the age group 15-17 years delivered prematurely as compared to only 26 girls (14% in the age group of 17-19 years. This difference is statistically significant. Also, only, 4 girls (29% in the age group of 15-17 years had full term normal delivery as compared to 113 girls (61% in the age group of 17-19 years signifying that the outcome of pregnancy becomes worst in girls below the age of 17 years. Ten babies (71% of mothers in the age group of 15-17 years were LBW as compared to 75 babies (44% of mothers in the age group of 17-19 years signifying that the incidence of LBW babies is inversely proportional to maternal age. Teenage pregnant girls needed more attention for prevention and treatment of preeclampsia eclampsia, anaemia, prematurity and LBW.

  9. Periodontal Disease and Pregnancy Outcomes

    OpenAIRE

    Babalola, Dolapo A.; Omole, Folashade

    2010-01-01

    An increasing number of studies are confirming an association between periodontal disease (PD) and adverse outcomes in pregnancy. PD places pregnant women at greater risk for preterm birth than alcohol consumption or smoking. This underscores the importance of offering dental screening to women who are pregnant or contemplating pregnancy and the need for physicians who provide obstetric care to be aware of the possible connection between poor dental health and poor pregnancy outcomes.

  10. Periodontal Disease and Pregnancy Outcomes

    Directory of Open Access Journals (Sweden)

    Dolapo A. Babalola

    2010-01-01

    Full Text Available An increasing number of studies are confirming an association between periodontal disease (PD and adverse outcomes in pregnancy. PD places pregnant women at greater risk for preterm birth than alcohol consumption or smoking. This underscores the importance of offering dental screening to women who are pregnant or contemplating pregnancy and the need for physicians who provide obstetric care to be aware of the possible connection between poor dental health and poor pregnancy outcomes.

  11. 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.

  12. Patient-reported outcomes in borderline personality disorder

    Science.gov (United States)

    Hasler, Gregor; Hopwood, Christopher J.; Jacob, Gitta A.; Brändle, Laura S.; Schulte-Vels, Thomas

    2014-01-01

    Patient-reported outcome (PRO) refers to measures that emphasize the subjective view of patients about their health-related conditions and behaviors. Typically, PROs include self-report questionnaires and clinical interviews. Defining PROs for borderline personality disorder (BPD) is particularly challenging given the disorder's high symptomatic heterogeneity, high comorbidity with other psychiatric conditions, highly fluctuating symptoms, weak correlations between symptoms and functional outcomes, and lack of valid and reliable experimental measures to complement self-report data. Here, we provide an overview of currently used BPD outcome measures and discuss them from clinical, psychometric, experimental, and patient perspectives. In addition, we review the most promising leads to improve BPD PROs, including the DSM-5 Section III, the Recovery Approach, Ecological Momentary Assessments, and novel experimental measures of social functioning that are associated with functional and social outcomes. PMID:25152662

  13. 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

  14. Pregnancy outcome following myomectomy.

    Science.gov (United States)

    Begum, N; Anwary, S A; Alfazzaman, M; Sultana, P; Banu, J; Deeba, F; Mahzabin, Z; Nahar, K N

    2015-01-01

    In developing countries, abdominal myomectomy is still a modality of treatment for large and symptomatic uterine fibroid in women who wish to retain their fertility and preserve uterus. In order to assess the outcome of pregnancies after myomectomy, a prospective observational study was carried out in the Department of Obstetrics and Gynaecology, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh, from July 1999 and June 2011. Study included 40 married women of reproductive age, suffering either from primary or secondary subfertility, and who had uterine fibroid and strongly wished to conceive shortly after myomectomy using microsurgical procedure with no existence of other male and female subfertility factor. These women were followed up at 3, 6, 12 and 24 month intervals over telephone and outdoor visits. Data were recorded on preformed questionnaires. Post myomectomy hysterosalpingography was done at about 16 weeks after myomectomy. Patients were advised to try for pregnancy after 16 weeks of operation. Maximum number of women belonged to age group 31-35 years (n=14, 35%); primary subfertility was 67.5% and secondary 32.5%; in maximum number of cases duration of subfertility was 2-5 years (n=22, 55%); type of fibroid were solitary (52.5%) and multiple (47.5%); type of myoma were intramural (75%), submucous (2.5%) and combined (22.5%); location of myoma were fundal (5%), anterior wall (25%), posterior wall (20%) and combined (50%); diameter of removed myoma were 8-10(20%) and >10cm (10%); uterine size before myomectomy were (in weeks) 25 (2.5%). Hysterosalpingography was done in 16(40%) cases, and the findings were both tube patent (62.5%), unilateral tubal block (31.2%) and bilateral tubal block (6.2%). Menorrhagia after myomectomy was present only in 5% cases. After uterine myomectomy, 14(35%) women conceived, common time interval between myomectomy and conception was 1-2 years (42.9%), conception was spontaneous in 71.4%. Out of 14 who

  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. Patient-reported outcomes (PROs) in chronic urticaria

    DEFF Research Database (Denmark)

    Moestrup, Kristian; Ghazanfar, Misbah N.; Thomsen, Simon F.

    2017-01-01

    Chronic urticaria is an itching skin disease which persists for more than 6 weeks. Chronic urticaria has great impact on the daily life of the patient, and the fluctuating nature of the symptoms complicates the monitoring and treatment of the disease. Currently, there are no reliable biomarkers...... to identify and measure disease activity in chronic spontaneous urticaria. Consequently, use of patient-reported outcomes (PROs) is crucial when evaluating and monitoring different aspects of chronic urticaria such as disease activity/severity, disease control, and quality of life. We present an overview...... of seven different PROs used in chronic urticaria and highlight their strengths, limitations, and use in clinical practice and research....

  17. 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...

  18. Early pregnancy azathioprine use and pregnancy outcomes.

    LENUS (Irish Health Repository)

    Cleary, Brian J

    2012-02-01

    BACKGROUND: Azathioprine (AZA) is used during pregnancy by women with inflammatory bowel disease (IBD), other autoimmune disorders, malignancy, and organ transplantation. Previous studies have demonstrated potential risks. METHODS: The Swedish Medical Birth Register was used to identify 476 women who reported the use of AZA in early pregnancy. The effect of AZA exposure on pregnancy outcomes was studied after adjustment for maternal characteristics that could act as confounders. RESULTS: The most common indication for AZA use was IBD. The rate of congenital malformations was 6.2% in the AZA group and 4.7% among all infants born (adjusted OR: 1.41, 95% CI: 0.98-2.04). An association between early pregnancy AZA exposure and ventricular\\/atrial septal defects was found (adjusted OR: 3.18, 95% CI: 1.45-6.04). Exposed infants were also more likely to be preterm, to weigh <2500 gm, and to be small for gestational age compared to all infants born. This effect remained for preterm birth and low birth weight when infants of women with IBD but without AZA exposure were used as a comparison group. A trend toward an increased risk of congenital malformations was found among infants of women with IBD using AZA compared to women with IBD not using AZA (adjusted OR: 1.42, 95% CI: 0.93-2.18). CONCLUSIONS: Infants exposed to AZA in early pregnancy may be at a moderately increased risk of congenital malformations, specifically ventricular\\/atrial septal defects. There is also an increased risk of growth restriction and preterm delivery. These associations may be confounded by the severity of maternal illness.

  19. Collecting Patient Reported Outcomes in the Wild: Opportunities and Challenges.

    Science.gov (United States)

    Cabitza, Federico; Dui, Linda Greta

    2018-01-01

    Collecting Patient Reported Outcomes (PROs) is generally seen as an effective way to assess the efficacy and appropriateness of medical interventions, from the patients' perspective. In 2016 the Galeazzi Orthopaedic Institute established a digitized program of PROs collection from spine, hip and knee surgery patients. In this work, we re-port the findings from the data analysis of the responses collected so far about the complementarity of PROs with respect to the data reported by the clinicians, and about the main biases that can undermine their validity and reliability. Although PROs collection is recognized as being far more complex than just asking the patients "how they feel" on a regular basis and it entails costs and devoted electronic platforms, we advocate their further diffusion for the assessment of health technology and clinical procedures.

  20. 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...

  1. 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.

  2. Physical violence during pregnancy and pregnancy outcomes in Ghana

    NARCIS (Netherlands)

    Pool, Michelle Sharon; Otupiri, Easmon; Owusu-Dabo, Ellis; de Jonge, Ank; Agyemang, Charles

    2014-01-01

    In pregnancy, violence can have serious health consequences that could affect both mother and child. In Ghana there are limited data on this subject. We sought to assess the relationship between physical violence during pregnancy and pregnancy outcomes (early pregnancy loss, perinatal mortality and

  3. Physical violence during pregnancy and pregnancy outcomes in Ghana

    NARCIS (Netherlands)

    Pool, M.S.; Otupiri, E.; Owusu-Dabo, E.; de Jonge, J.; Agyemang, C.

    2014-01-01

    Background: In pregnancy, violence can have serious health consequences that could affect both mother and child. In Ghana there are limited data on this subject. We sought to assess the relationship between physical violence during pregnancy and pregnancy outcomes (early pregnancy loss, perinatal

  4. Thyroid dysfunction and pregnancy outcomes

    Directory of Open Access Journals (Sweden)

    Sima Nazarpour

    2015-07-01

    Full Text Available Background: Pregnancy has a huge impact on the thyroid function in both healthy women and those that have thyroid dysfunction. The prevalence of thyroid dysfunction in pregnant women is relatively high. Objective: The objective of this review was to increase awareness and to provide a review on adverse effect of thyroid dysfunction including hyperthyroidism, hypothyroidism and thyroid autoimmune positivity on pregnancy outcomes. Materials and Methods: In this review, Medline, Embase and the Cochrane Library were searched with appropriate keywords for relevant English manuscript. We used a variety of studies, including randomized clinical trials, cohort (prospective and retrospective, case-control and case reports. Those studies on thyroid disorders among non-pregnant women and articles without adequate quality were excluded. Results: Overt hyperthyroidism and hypothyroidism has several adverse effects on pregnancy outcomes. Overt hyperthyroidism was associated with miscarriage, stillbirth, preterm delivery, intrauterine growth retardation, low birth weight, preeclampsia and fetal thyroid dysfunction. Overt hypothyroidism was associated with abortion, anemia, pregnancy-induced hypertension, preeclampsia, placental abruption, postpartum hemorrhage, premature birth, low birth weight, intrauterine fetal death, increased neonatal respiratory distress and infant neuro developmental dysfunction. However the adverse effect of subclinical hypothyroidism, and thyroid antibody positivity on pregnancy outcomes was not clear. While some studies demonstrated higher chance of placental abruption, preterm birth, miscarriage, gestational hypertension, fetal distress, severe preeclampsia and neonatal distress and diabetes in pregnant women with subclinical hypothyroidism or thyroid autoimmunity; the other ones have not reported these adverse effects. Conclusion: While the impacts of overt thyroid dysfunction on feto-maternal morbidities have been clearly

  5. Cognitive reserve and patient-reported outcomes in multiple sclerosis.

    Science.gov (United States)

    Schwartz, Carolyn E; Snook, Erin; Quaranto, Brian; Benedict, Ralph H B; Vollmer, Timothy

    2013-01-01

    Adaptation and compensation in the face of changing pathology may be better understood by considering the concept of cognitive reserve, which may protect against disability in multiple sclerosis (MS). The present work investigates the relationship between cognitive reserve and demographic characteristics, health behaviors, and patient-reported outcomes (PROs). Cross-sectional data (n=1142) were drawn from the North American Research Committee on MS (NARCOMS) Registry, from whom additional survey data were collected. Cognitive reserve was measured using the Stern and Sole-Padulles measures, the O*NET occupational classification system, and the Godin Leisure-Time Exercise Questionnaire. PROs were assessed using generic (SF -12v2, Perceived Deficits Questionnaire, Ryff Psychological Well-Being, Diener Satisfaction with Life Scale) and disease-specific (Patient-Determined Disease Steps, Performance Scales) measures. Psychometric analysis created unidimensional cognitive reserve subscales. Regression models examined relationships between cognitive reserve, demographic characteristics, and PROs. The cognitive reserve measures assessed distinct but related constructs. Individuals with high cognitive reserve were more likely to report lower levels of perceived disability and perceived cognitive deficits, and higher levels of physical health, mental health, and well-being. Both active and passive reserve are associated with better outcomes, independent of demographic factors, and these associations apply to both generic and disease-specific outcomes. This expanded measurement of cognitive reserve captures both the passive and active aspects of the construct, and there is a consistent and substantial relationship with PROs. Individuals with high passive and/or active reserve are healthier and experience higher levels of well-being.

  6. Clinical and patient reported outcomes of bleaching effectiveness.

    Science.gov (United States)

    Klaric Sever, Eva; Budimir, Zrinka; Cerovac, Matea; Stambuk, Mario; Par, Matej; Negovetic Vranic, Dubravka; Tarle, Zrinka

    2018-01-01

    The objective of this study is to evaluate clinical and patient reported outcomes of different bleaching products. Thirty participants were randomly divided into three bleaching groups (n = 10). Bleaching was performed with high concentrations of hydrogen peroxide (HP) - Boost (40%) and Dash (30%), and with prefabricated splints Bite&White (6% HP). Tooth colour was measured before, immediately after, and 1 and 6 months after the bleaching by using classical shade guide and spectrophotometer. Tooth hypersensitivity was self-rated by patients on the Wong-Baker's face scale. Patient satisfaction was evaluated on a 7-point Likert-type scales that measured perceived performance and importance of different characteristics of bleaching treatment. All products were effective in teeth colour change (ΔE > 3.3), which was significantly higher for Boost (p = .016) and Dash (p = .024) than Bite&White treatment. Perception of hypersensitivity was the highest in Boost group, followed by Dash and Bite&White treatment. Most of the patients were satisfied with final tooth colour, length and comfort during treatment, but were dissatisfied with the stability of bleached tooth colour. Materials with the higher concentrations of bleaching agent demonstrated greater bleaching effectiveness than at-home bleaching product, but also a greater hypersensitivity. Lengthening the treatment process, but achieving a more stable tooth colour may improve the perceived value of a bleaching service.

  7. Does CPAP Affect Patient-Reported Voice Outcomes?

    Science.gov (United States)

    Hartke, Vance; Gillespie, Amanda; Smith, Libby J; Soose, Ryan J

    2018-04-01

    Upper aerodigestive tract symptoms are common in patients with obstructive sleep apnea (OSA). It remains unclear whether continuous positive airway pressure (CPAP) improves or worsens these otolaryngology symptoms. As therapy-related side effects limit CPAP adherence, this study aimed to determine if CPAP negatively affects voice, sinonasal, and reflux symptoms of the upper airway. Case series with planned data collection was performed at an academic otolaryngology sleep center. Newly diagnosed patients with OSA were evaluated before and 6 months after initiating CPAP therapy. Data collected included CPAP data download, Reflux Symptom Index (RSI), Epworth Sleepiness Scale (ESS), Voice Handicap Index 10 (VHI-10), Sino-Nasal Questionnaire (SNQ), and oral dryness visual analog scale (VAS). For the 11 CPAP-adherent participants, the RSI significantly improved with CPAP (mean RSI, 22.0-9.5; P = .002); however, the VAS, VHI-10, and SNQ did not change after 6 months of CPAP therapy. In a small sample size, patient-reported voice outcomes (VHI-10) and other upper aerodigestive tract symptoms did not worsen with CPAP; rather, CPAP therapy was associated with a reduction in reflux symptoms.

  8. Patient Compliance With Electronic Patient Reported Outcomes Following Shoulder Arthroscopy.

    Science.gov (United States)

    Makhni, Eric C; Higgins, John D; Hamamoto, Jason T; Cole, Brian J; Romeo, Anthony A; Verma, Nikhil N

    2017-11-01

    To determine the patient compliance in completing electronically administered patient-reported outcome (PRO) scores following shoulder arthroscopy, and to determine if dedicated research assistants improve patient compliance. Patients undergoing arthroscopic shoulder surgery from January 1, 2014, to December 31, 2014, were prospectively enrolled into an electronic data collection system with retrospective review of compliance data. A total of 143 patients were included in this study; 406 patients were excluded (for any or all of the following reasons, such as incomplete follow-up, inaccessibility to the order sets, and inability to complete the order sets). All patients were assigned an order set of PROs through an electronic reporting system, with order sets to be completed prior to surgery, as well as 6 and 12 months postoperatively. Compliance rates of form completion were documented. Patients who underwent arthroscopic anterior and/or posterior stabilization were excluded. The average age of the patients was 53.1 years, ranging from 20 to 83. Compliance of form completion was highest preoperatively (76%), and then dropped subsequently at 6 months postoperatively (57%) and 12 months postoperatively (45%). Use of research assistants improved compliance by approximately 20% at each time point. No differences were found according to patient gender and age group. Of those completing forms, a majority completed forms at home or elsewhere prior to returning to the office for the clinic visit. Electronic administration of PRO may decrease the amount of time required in the office setting for PRO completion by patients. This may be mutually beneficial to providers and patients. It is unclear if an electronic system improves patient compliance in voluntary completion PRO. Compliance rates at final follow-up remain a concern if data are to be used for establishing quality or outcome metrics. Level IV, case series. Copyright © 2017 Arthroscopy Association of North

  9. Inter-pregnancy interval and pregnancy outcomes among HIV ...

    African Journals Online (AJOL)

    owner

    Abstract Background: Both short and long inter-pregnancy intervals have been associated with higher risk of adverse pregnancy outcomes. More so, short inter- pregnancy interval among HIV- positive women implies higher birth rate and subsequently a higher number of neonates exposed to HIV and potentially at.

  10. 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.

  11. Patient-reported outcomes, patient-reported information: from randomized controlled trials to the social web and beyond.

    Science.gov (United States)

    Baldwin, Mike; Spong, Andrew; Doward, Lynda; Gnanasakthy, Ari

    2011-01-01

    Internet communication is developing. Social networking sites enable patients to publish and receive communications very easily. Many stakeholders, including patients, are using these media to find new ways to make sense of diseases, to find and discuss treatments, and to give support to patients and their caregivers. We argue for a new definition of patient-reported information (PRI), which differs from the usual patient-reported outcomes (PRO). These new emergent data from the social web have important implications for decision making, at both an individual and a population level. We discuss new emergent technologies that will help aggregate this information and discuss how this will be assessed alongside the use of PROs in randomized controlled trials and how these new emergent data will be one facet of changing the relationship between the various stakeholders in achieving better co-created health.

  12. Psychometric properties of patient-reported outcome measures for hip arthroscopic surgery

    DEFF Research Database (Denmark)

    Kemp, Joanne L; Collins, Natalie J; Roos, Ewa M.

    2013-01-01

    Patient-reported outcomes (PROs) are considered the gold standard when evaluating outcomes in a surgical population. While the psychometric properties of some PROs have been tested, the properties of newer PROs in patients undergoing hip arthroscopic surgery remain somewhat unknown.......Patient-reported outcomes (PROs) are considered the gold standard when evaluating outcomes in a surgical population. While the psychometric properties of some PROs have been tested, the properties of newer PROs in patients undergoing hip arthroscopic surgery remain somewhat unknown....

  13. Fetomaternal outcome in triplet pregnancy

    International Nuclear Information System (INIS)

    Mazhar, S.B.; Furukh, T; Rahim, F.

    2008-01-01

    To determine maternal outcome as antenatal and postnatal complications and neonatal outcome as birth weight, morbidity and mortality in triplet gestation. All the patients with triplet pregnancy beyond 28 weeks gestation, who delivered at the study place during above period were included in the study. The primary outcome measures were frequency of maternal complications and neonatal birth, weight and morbidity. Secondary outcome measures included the frequency of assisted conception in the studied cohart. Eighteen women had triplet pregnancy beyond 28 weeks. Nine were booked, 6 non-booked and 3 of them were referred. Mean duration of gestation was 237.8 days (33.8 weeks). The antenatal complications were preterm delivery in 50%, hypertension in 50%, anemia in 44.4% and obstetric cholestasis in 5.6%. Eight patients (44.4%) suffered postpartum hemorrhage. One patient had peripartum hysterectomy and later expired in intensive care unit after three weeks. Maternal mortality ratio was 5.6%. Fifty five percent women had induction of ovulation with Clomiphene, while none had In Vitro Fertilization (IVF) or Intracytoplasmic Insemination (ICSI) or received gonadotrophins. Fifteen sets of triplets were delivered abdominally. Mean birth weights of 1st, 2nd and 3rd triplet were 1651, 1640 and 1443 grams respectively. Five sets of triplets (27.8%) had more than 25% discordance for birth weight. The mean Apgar scores of the babies at 1 and 10 minutes after birth were 6.0 and 8.0, 5.6 and 7.5; and 5.2 and 7.0 respectively. Of the 54 infants, 18 required Neonatal Intensive Care Unit (NICU) admission and 14 were admitted in nursery. Two died shortly after birth. Total perinatal mortalities were 13 including 4 cases of intra-uterine demise. Three babies suffered from jaundice, 7 had sepsis and 8 had respiratory distress syndrome. Triplet gestation had a high rate of fetomaternal complications. Majority had history of assisted conception. (author)

  14. Inter-pregnancy interval and pregnancy outcomes among HIV ...

    African Journals Online (AJOL)

    Background: Both short and long inter-pregnancy intervals have been associated with higher risk of adverse pregnancy outcomes. More so, short interpregnancy interval among HIVpositive women implies higher birth rate and subsequently a higher number of neonates exposed to HIV and potentially at r i s k o f mo t h e r ...

  15. Using patient-reported outcomes in schizophrenia: the Scottish Schizophrenia Outcomes Study.

    Science.gov (United States)

    Hunter, Robert; Cameron, Rosie; Norrie, John

    2009-02-01

    The primary aim of the Scottish Schizophrenia Outcomes Study (SSOS) was to assess the feasibility and utility of routinely collecting outcome data in everyday clinical settings. Data were collected over three years in the Scottish National Health Service (NHS). There were two secondary aims of SSOS: first, to compare data from patient-rated, objective, and clinician-rated outcomes, and second, to describe trends in outcome data and service use across Scotland over the three years of the study (2002-2005). This study used a naturalistic, longitudinal, observational cohort design. A representative sample of 1,015 persons with ICD-10 F20-F29 diagnoses (schizophrenia, schizotypal disorders, or delusional disorders) was assessed annually using the clinician-rated measure, the Health of the Nation Outcome Scale (HoNOS), and the patient-reported assessment, the Avon Mental Health Measure (Avon). Objective outcomes data and information on services and interventions were collected. Data were analyzed with regression modeling. Of the 1,015 persons recruited, 78% of the cohort (N=789) completed the study. Over the study period, significant decreases were seen in the number of hospitalizations, incidence of attempted suicide and self-harm, and civil detentions. Avon scores indicated significant improvement on all subscales (behavior, social, access, and mental health) and on the total score. However, HoNOS scores on the behavior and symptom subscales did not change, scores on the impairment subscale increased significantly (indicating increased levels of impairment), and scores on the social subscale decreased significantly (indicating improved social functioning). This study has demonstrated that it is feasible within the Scottish NHS to routinely collect meaningful outcomes data in schizophrenia. Patient-reported assessments were also successfully collected and used in care plans. This model shows that it is possible to incorporate patient-reported assessments into routine

  16. Pregnancy outcome in inflammatory bowel disease

    DEFF Research Database (Denmark)

    Bortoli, A; Pedersen, N; Duricova, D

    2011-01-01

    Inflammatory bowel disease (IBD) frequently affects women during their reproductive years. Pregnancy outcome in women with IBD is well described, particularly in retrospective studies.......Inflammatory bowel disease (IBD) frequently affects women during their reproductive years. Pregnancy outcome in women with IBD is well described, particularly in retrospective 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. Heterotopic pregnancy - outcome and management

    International Nuclear Information System (INIS)

    Zahoor, S.; Hussain, M.; Yasmin, H.; Noorani, K.J.

    2004-01-01

    A case of heterotopic pregnancy is reported that presented with 7 weeks of amenorrhea, lower abdominal pain and spotting per vaginum. Ultrasound showed an intra-uterine gestational sac as well as right-sided ruptured tubal pregnancy. Emergency laparotomy and right salpingectomy was performed. Subsequent ongoing alive intra-uterine pregnancy was delivered by vaginal route at term. (author)

  19. Patient-reported outcome after fast-track knee arthroplasty

    DEFF Research Database (Denmark)

    Larsen, Kristian; Hansen, Torben B; Søballe, Kjeld

    2012-01-01

    PURPOSE: The purpose of this study was to describe patient-related functional outcomes after fast-track total knee arthroplasty and unicompartmental knee arthroplasty. Furthermore, we wanted to assess physical areas where an additional need for rehabilitation could be identified, and finally, we...

  20. Patient-reported outcomes for total hip and knee arthroplasty

    DEFF Research Database (Denmark)

    Collins, Natalie J; Roos, Ewa M.

    2012-01-01

    Although the effectiveness of THA and TKA as interventions for end-stage degenerative joint disease has been well established, the use of instruments that measure outcome from the patient's perspective are relatively poorly investigated. Considering the increasing prevalence, associated risks, an...

  1. 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....

  2. Pregnancy Outcomes Among Patients With Vasculitis

    Science.gov (United States)

    Clowse, Megan E. B.; Richeson, Rachel L.; Pieper, Carl; Merkel, Peter A.

    2015-01-01

    Objective Pregnancy outcomes of patients with vasculitis are unknown, but are of great concern to patients and physicians. Through an online survey, this study assessed pregnancy outcomes among patients with vasculitis. Methods Participants in the Vasculitis Clinical Research Consortium Patient Contact Registry were invited to respond to an anonymous, internet-based survey that included questions about pregnancy outcomes, the timing of pregnancy relative to a diagnosis of vasculitis, and medication use. Results A total of 350 women and 113 men completed the survey. After a diagnosis of vasculitis, 74 pregnancies were reported by women and 18 conceptions were reported by men. The rate of pregnancy loss was higher among women who conceived after a diagnosis of vasculitis compared to those who conceived prior to diagnosis (33.8% versus 22.4%; P = 0.04). Among women, the rate of preterm births increased significantly for pregnancies conceived after a diagnosis of vasculitis relative to those conceived before diagnosis (23.3% versus 11.4%; P = 0.03). Only 18% of women reported worsening of vasculitis during pregnancy, but those who experienced increased vasculitis activity were more likely to deliver preterm. Exposure to cyclophosphamide or prednisone did not appear to impact pregnancy outcomes; however, the number of pregnancies among women taking these medications was small. Among the pregnancies conceived by men with vasculitis, the timing of diagnosis had no significant effect on the rate of pregnancy loss. Conclusion Women who conceived after a diagnosis of vasculitis had a higher rate of pregnancy loss than those who conceived prior to diagnosis. Vasculitis did not worsen during the majority of pregnancies conceived after diagnosis. PMID:23401494

  3. Patient-Reported Outcomes in Weight Loss and Body Contouring Surgery

    DEFF Research Database (Denmark)

    Poulsen, Lotte; Klassen, Anne; Rose, Michael

    2017-01-01

    BACKGROUND: Health-related quality of life and satisfaction with appearance are important outcomes in bariatric and body contouring surgery. To investigate these outcomes, scientifically sound and clinically meaningful patient-reported outcome instruments are needed. The authors measured health-r...

  4. [Outcome Quality in Medical Rehabilitation: Relationship Between "Patient-Reported Outcomes" (PROs) and Social Security Contributions].

    Science.gov (United States)

    Nübling, R; Kaluscha, R; Krischak, G; Kriz, D; Martin, H; Müller, G; Renzland, J; Reuss-Borst, M; Schmidt, J; Kaiser, U; Toepler, E

    2017-02-01

    Aim of the Study The outcome quality of medical rehabilitation is evaluated often by "Patient Reported Outcomes" (PROs). It is examined to what extent these PROs are corresponding with "hard" or "objective" outcomes such as payments of contributions to social insurance. Methods The "rehabilitation QM outcome study" includes self-reports of patients as well as data from the Rehabilitation Statistics Database (RSD) of the German pension insurance Baden-Wurttemberg. The sample for the question posed includes N=2 947 insured who were treated in 2011 in 21 clinics of the "health quality network" and who were either employed or unemployed at the time of the rehabilitation application (e. g. the workforce or labour force group, response rate: 55%). The sample turned out widely representative for the population of the insured persons. Results PROs and payment of contributions to pension insurance clearly correspond. In the year after the rehabilitation improved vs. not improved rehabilitees differed clearly with regard to their payments of contributions. Conclusions The results support the validity of PROs. For a comprehensive depiction of the outcome quality of rehabilitation PROs and payments of contributions should be considered supplementary. © Georg Thieme Verlag KG Stuttgart · New York.

  5. Fathers' occupation and pregnancy outcome

    International Nuclear Information System (INIS)

    McDonald, A.D.; McDonald, J.C.; Armstrong, B.; Cherry, N.M.; Nolin, A.D.; Robert, D.

    1989-01-01

    Findings from a survey of 56,067 women in Montreal on maternal occupation and pregnancy outcome have been reported. Paternal occupation recorded in the same survey was analysed for spontaneous abortion in 24 occupational groups retaining the six main sectors of maternal occupation and allowing, by means of logistic regression, for seven potentially confounding variables. In only one of the 24 fathers' occupational groups was there a statistically significant excess of spontaneous abortions-mechanics, repairers, and certain assemblers (O/E = 1.10, 90% CI = 1.02-1.20); subdivision of this group suggested that this excess was mainly attributable to the large group of motor vehicle mechanics (O/E = 1.17). No significant excess of known chromosomally determined defects was found in any of the 24 occupational groups. An association of developmental defects was found with food and beverage processing (18 defects observed compared with 8.02 expected; p < 0.05); however, there was no specificity in type of food, beverage, or congenital defect, and no obvious explanatory mechanism. (author)

  6. 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.

  7. Maternal Dietary Patterns and Pregnancy Outcome

    Science.gov (United States)

    Chen, Xuyang; Zhao, Diqi; Mao, Xun; Xia, Yinyin; Baker, Philip N.; Zhang, Hua

    2016-01-01

    Maternal nutritional status during pregnancy will affect the outcomes for the mother and the baby. Many analyses of the relationship between diet and outcome are often based on a single or a few food items or nutrients. However, foods are not consumed in isolation and dietary patterns can be used to assess the whole diet consumed. The use of dietary pattern analysis to understand nutritional intake and pregnancy outcome is becoming more and more popular. Many published studies have showed the association between maternal dietary patterns and pregnancy outcome. This review examined articles about the relationship between maternal dietary patterns and pregnancy outcome. As a modifiable factor, dietary patterns may be more applicable to clinical and pregnant health interventions. PMID:27338455

  8. Yoga & Cancer Interventions: A Review of the Clinical Significance of Patient Reported Outcomes for Cancer Survivors

    Directory of Open Access Journals (Sweden)

    S. Nicole Culos-Reed

    2012-01-01

    Full Text Available Limited research suggests yoga may be a viable gentle physical activity option with a variety of health-related quality of life, psychosocial and symptom management benefits. The purpose of this review was to determine the clinical significance of patient-reported outcomes from yoga interventions conducted with cancer survivors. A total of 25 published yoga intervention studies for cancer survivors from 2004–2011 had patient-reported outcomes, including quality of life, psychosocial or symptom measures. Thirteen of these studies met the necessary criteria to assess clinical significance. Clinical significance for each of the outcomes of interest was examined based on 1 standard error of the measurement, 0.5 standard deviation, and relative comparative effect sizes and their respective confidence intervals. This review describes in detail these patient-reported outcomes, how they were obtained, their relative clinical significance and implications for both clinical and research settings. Overall, clinically significant changes in patient-reported outcomes suggest that yoga interventions hold promise for improving cancer survivors' well-being. This research overview provides new directions for examining how clinical significance can provide a unique context for describing changes in patient-reported outcomes from yoga interventions. Researchers are encouraged to employ indices of clinical significance in the interpretation and discussion of results from yoga studies.

  9. Subsequent pregnancy outcome after previous foetal death

    NARCIS (Netherlands)

    Nijkamp, J. W.; Korteweg, F. J.; Holm, J. P.; Timmer, A.; Erwich, J. J. H. M.; van Pampus, M. G.

    Objective: A history of foetal death is a risk factor for complications and foetal death in subsequent pregnancies as most previous risk factors remain present and an underlying cause of death may recur. The purpose of this study was to evaluate subsequent pregnancy outcome after foetal death and to

  10. Maternal use of cannabis and pregnancy outcome.

    Science.gov (United States)

    Fergusson, David M; Horwood, L John; Northstone, Kate

    2002-01-01

    To document the prevalence of cannabis use in a large sample of British women studied during pregnancy, to determine the association between cannabis use and social and lifestyle factors and assess any independent effects on pregnancy outcome. Self-completed questionnaire on use of cannabis before and during pregnancy. Over 12,000 women expecting singletons at 18 to 20 weeks of gestation who were enrolled in the Avon Longitudinal Study of Pregnancy and Childhood. Any association with the use of cannabis before and during pregnancy with pregnancy outcome was examined, taking into account potentially confounding factors including maternal social background and other substance use during pregnancy. Late fetal and perinatal death, special care admission of the newborn infant, birthweight, birth length and head circumference. Five percent of mothers reported smoking cannabis before and/or during pregnancy; they were younger, of lower parity, better educated and more likely to use alcohol, cigarettes, coffee, tea and hard drugs. Cannabis use during pregnancy was unrelated to risk of perinatal death or need for special care, but, the babies of women who used cannabis at least once per week before and throughout pregnancy were 216 g lighter than those of non-users, had significantly shorter birth lengths and smaller head circumferences. After adjustment for confounding factors, the association between cannabis use and birthweight failed to be statistically significant (P = 0.056) and was clearly non-linear: the adjusted mean birthweights for babies of women using cannabis at least once per week before and throughout pregnancy were 90 g lighter than the offspring of other women. No significant adjusted effects were seen for birth length and head circumference. The results of this study suggest that the use of cannabis during pregnancy was not associated with increased risk of perinatal mortality or morbidity in this sample. However, frequent and regular use of cannabis

  11. Early patient-reported outcomes versus objective function after total hip and knee arthroplasty

    DEFF Research Database (Denmark)

    Luna, I E; Kehlet, H; Peterson, B

    2017-01-01

    AIMS: The purpose of this study was to assess early physical function after total hip or knee arthroplasty (THA/TKA), and the correlation between patient-reported outcome measures, physical performance and actual physical activity (measured by actigraphy). PATIENTS AND METHODS: A total of 80...... patients aged 55 to 80 years undergoing THA or TKA for osteoarthritis were included in this prospective cohort study. The main outcome measure was change in patient reported hip or knee injury and osteoarthritis outcome score (HOOS/KOOS) from pre-operatively until post-operative day 13 (THA) or 20 (TKA...

  12. Impact of antiretroviral therapy on pregnancy outcomes

    African Journals Online (AJOL)

    However, there are mixed data regarding the impact of ART on pregnancy outcomes. .... to point out that the use of illicit drugs, alcohol abuse and cigarette ... Carceller A, Ferreira E, Alloul S, Lapointe N. Lack of effect on prematurity, birth.

  13. Patient reported outcomes in pediatric oncology practice: suggestions for future usage by parents and pediatric oncologists

    NARCIS (Netherlands)

    Schepers, S. A.; Engelen, V. E.; Haverman, L.; Caron, H. N.; Hoogerbrugge, P. M.; Kaspers, G. J. L.; Egeler, R. M.; Grootenhuis, M. A.

    2014-01-01

    Several studies in adults have shown patient reported outcomes (PROs) to be effective in enhancing patient-physician communication and discussion of Health Related Quality of Life outcomes. Although less studied, positive results have been demonstrated in children. A PRO-intervention needs to be

  14. mHealth and big data will bring meaning and value to patient-reported outcomes.

    Science.gov (United States)

    Weiler, Anne

    2016-01-01

    The intersection of widespread mobile adoption, cloud computing and healthcare will enable patient-reported outcomes to be used to personalize care, draw insights and shorten the cycle from research to clinical implementation. Today, patient-reported outcomes are largely collected as part of a regulatory shift to value-based or bundled care. When patients are able to record their experiences in real-time and combine them with passive data collection from sensors and mobile devices, this information can inform better care for each patient and contribute to the growing body of health data that can be used to draw insights for all patients. This paper explores the current limitations of patient reported outcomes and how mobile health and big data analysis unlocks their potential as a valuable tool to deliver care.

  15. AMCP Partnership Forum: Improving Quality, Value, and Outcomes with Patient-Reported Outcomes.

    Science.gov (United States)

    2018-03-01

    Patient-reported outcomes (PROs), which provide a direct measure of a patient's health status or treatment preferences, represent a key component of the shift toward patient-centered health care. PROs can measure the state of a patient's disease-specific and overall health throughout the care continuum, enabling them to have a variety of uses for key health care stakeholders. Currently, PROs are used in drug development, aligning patient and clinician goals in care, quality-of-care measures, and coverage and reimbursement decisions. While there have been significant strides by key health care stakeholders to further the development and use of PROs, there are a number of challenges limiting more widespread use. In light of these current challenges and the potential for PROs to improve health care quality and value, on October 19, 2017, the Academy of Managed Care Pharmacy convened a forum of key stakeholders representing patients, payers, providers, government, and pharmaceutical companies to discuss and identify solutions to the current challenges and barriers to further use of PROs. These discussions informed the development of participants' ideal future state in which PROs maximize the goals of all health care stakeholders and the actionable steps required to make the future state a reality. While stakeholders shared unique perspectives throughout the forum, they had consensus on 2 overarching issues: the importance of PROs in defining value, improving patient care, and implementing value-based payment models and the need for strong organizational and operational systems to achieve optimal adoption and use. Participants identified several key challenges in PRO use and adoption: achieving a representative patient population, inclusion of PRO data in medication labels, the necessity for both standardized and customizable PROs, and operational and organizational barriers to collecting and analyzing PROs. To overcome these challenges, participants recommended that

  16. PATIENT-REPORTED OUTCOMES (PROs): PUTTING THE PATIENT PERSPECTIVE IN PATIENT-CENTERED OUTCOMES RESEARCH

    Science.gov (United States)

    Snyder, Claire F.; Jensen, Roxanne E.; Segal, Jodi B.; Wu, Albert W.

    2013-01-01

    Patient-centered outcomes research (PCOR) aims to improve care quality and patient outcomes by providing information that patients, clinicians, and family members need regarding treatment alternatives, and emphasizing patient input to inform the research process. PCOR capitalizes on available data sources and generates new evidence to provide timely and relevant information and can be conducted using prospective data collection, disease registries, electronic medical records, aggregated results from prior research, and administrative claims. Given PCOR’s emphasis on the patient perspective, methods to incorporate patient-reported outcomes (PROs) are critical. PROs are defined by the U.S. Food & Drug Administration as “Any report coming directly from patients… about a health condition and its treatment.” However, PROs have not routinely been collected in a way that facilitates their use in PCOR. Electronic medical records, disease registries, and administrative data have only rarely collected, or been linked to, PROs. Recent technological developments facilitate the electronic collection of PROs and linkage of PRO data, offering new opportunities for putting the patient perspective in PCOR. This paper describes the importance of and methods for using PROs for PCOR. We (1) define PROs; (2) identify how PROs can be used in PCOR, and the critical role of electronic data methods for facilitating the use of PRO data in PCOR; (3) outline the challenges and key unanswered questions that need to be addressed for the routine use of PROs in PCOR; and (4) discuss policy and research interventions to accelerate the integration of PROs with clinical data. PMID:23774513

  17. Pregnancy outcome in elderly primigravidae

    African Journals Online (AJOL)

    shobha

    139-41. 3. Chloe V, Fretts R. Pregnancy and advanced maternal age. In: Studd J, Lintan S, Chervena KF editors Progress in Obstetrics and Gynaecology. 17th ed. Philadelphia: Elsevier publishers; 2006. P. 113-24. 4. Center for Disease Control.

  18. 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

  19. Bipolar Disorder in Pregnancy: A Review of Pregnancy Outcomes.

    Science.gov (United States)

    Scrandis, Debra A

    2017-11-01

    Women with bipolar disorder may benefit from continuation of their medications during pregnancy, but there may be risks to the fetus associated with some of these medications. This article examines the evidence relating to the effect of bipolar disorder and pharmacologic treatments for bipolar disorder on pregnancy outcomes. MEDLINE, CINAHL, ProQuest Dissertation & Theses, and the Cochrane Database of Systematic Reviews were searched for English-language studies published between 2000 and 2017, excluding case reports and integrative reviews. Twenty articles that met inclusion criteria were included in this review. Women with bipolar disorder have a higher risk for pregnancy complications and congenital abnormalities than do women without bipolar disorder. In addition, illness relapse can occur if psychotropic medications are discontinued. There are limited data to recommend discontinuing lithium, lamotrigine, or carbamazepine during pregnancy. Valproic acid is not recommended during pregnancy due to increased odds of neural tube defects associated with its use. Atypical antipsychotics are used more frequently during pregnancy, with mixed evidence regarding an association between these agents and congenital malformations or preterm birth. The knowledge of benefits and risks of bipolar disorder and its treatment can help women and health care providers make individualized decisions. Prenatal care providers can discuss the evidence about safety of medications used to treat bipolar disorder with women in collaboration with their mental health care providers. In addition, women being treated for bipolar disorder require close monitoring for depressive and manic/hypomanic episodes that impact pregnancy outcomes. © 2017 by the American College of Nurse-Midwives.

  20. Pregnancy Outcomes After Myomectomy With Polytetrafluoroethylene Placement

    OpenAIRE

    Eaton, Jennifer L.; Milad, Magdy P.

    2014-01-01

    Background and Objectives: The aim of this study was to report preliminary data on pregnancy outcomes after myomectomy with placement of an expanded polytetrafluoroethylene adhesion barrier membrane. Methods: In this retrospective case series, 68 women who underwent myomectomy with expanded polytetrafluoroethylene membrane placement between January 1, 2003, and December 31, 2009, were identified. Of these women, 15 subsequently had documented pregnancies and were included in the final dataset...

  1. A hierarchy of patient-reported outcomes for meta-analysis of knee osteoarthritis trials

    DEFF Research Database (Denmark)

    Juhl, Carsten; Lund, Hans; Roos, Ewa M

    2012-01-01

    Objectives. To develop a prioritised list based on responsiveness for extracting patient-reported outcomes (PROs) measuring pain and disability for performing meta-analyses in knee osteoarthritis (OA). Methods. A systematic search was conducted in 20 highest impact factor general and rheumatology...

  2. 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...

  3. Overcoming barriers to implementing patient-reported outcomes in an electronic health record: a case report.

    Science.gov (United States)

    Harle, Christopher A; Listhaus, Alyson; Covarrubias, Constanza M; Schmidt, Siegfried Of; Mackey, Sean; Carek, Peter J; Fillingim, Roger B; Hurley, Robert W

    2016-01-01

    In this case report, the authors describe the implementation of a system for collecting patient-reported outcomes and integrating results in an electronic health record. The objective was to identify lessons learned in overcoming barriers to collecting and integrating patient-reported outcomes in an electronic health record. The authors analyzed qualitative data in 42 documents collected from system development meetings, written feedback from users, and clinical observations with practice staff, providers, and patients. Guided by the Unified Theory on the Adoption and Use of Information Technology, 5 emergent themes were identified. Two barriers emerged: (i) uncertain clinical benefit and (ii) time, work flow, and effort constraints. Three facilitators emerged: (iii) process automation, (iv) usable system interfaces, and (v) collecting patient-reported outcomes for the right patient at the right time. For electronic health record-integrated patient-reported outcomes to succeed as useful clinical tools, system designers must ensure the clinical relevance of the information being collected while minimizing provider, staff, and patient burden. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  4. Patient reported outcomes in chronic skin diseases: eHealth applications for clinical practice

    NARCIS (Netherlands)

    van Cranenburgh, O.D.

    2016-01-01

    The overall aim of this thesis was to examine and integrate patient reported outcomes (PROs) in dermatological care. In part I, we specifically examined health-related quality of life (HRQoL), treatment satisfaction, and experiences with care in patients with chronic skin diseases. Our results

  5. 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

  6. Improving a newly developed patient-reported outcome for thyroid patients, using cognitive interviewing

    DEFF Research Database (Denmark)

    Watt, Torquil; Rasmussen, Ase Krogh; Groenvold, Mogens

    2008-01-01

    Objective To improve a newly developed patient-reported outcome measure for thyroid patients using cognitive interviewing. Methods Thirty-one interviews using immediate retrospective and expansive probing were conducted among patients with non-toxic goiter (n = 4), nodular toxic goiter (n = 5) Gr...

  7. 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

  8. 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

  9. The case for an international patient-reported outcomes measurement information system (PROMIS®) initiative

    NARCIS (Netherlands)

    Alonso, J.; Bartlett, S.J.; Rose, M.; Aaronson, N.K.; Chaplin, J.; Efficace, F.; Leplège, A.; Aiping, L.U.; Tulsky, D.S.; Raat, H.; Ravens-Sieberer, U.; Revicki, D.; Terwee, C.B.; Valderas, J.M.; Cella, D.; Forrest, C.B.

    2013-01-01

    Patient-reported outcomes (PROs) play an increasingly important role in clinical practice and research. Modern psychometric methods such as item response theory (IRT) enable the creation of item banks that support fixed-length forms as well as computerized adaptive testing (CAT), often resulting in

  10. The case for an international patient-reported outcomes measurement information system (PROMIS®) initiative

    NARCIS (Netherlands)

    J. Alonso (Jordi); S.J. Bartlett (Susan); M. Rose (Matthias); N.K. Aaronson (Neil); J.E. Chaplin (John); F. Efficace (Fabio); A. Leplège (Alain); A. LU (Aiping); D.S. Tulsky (David); H. Raat (Hein); U. Ravens-Sieberer (Ulrike); D. Revicki (Dennis); C.B. Terwee (Caroline); J.M. Valderas (Jose); D. Cella (David); C.B. Forrest (Christopher)

    2013-01-01

    textabstractPatient-reported outcomes (PROs) play an increasingly important role in clinical practice and research. Modern psychometric methods such as item response theory (IRT) enable the creation of item banks that support fixed-length forms as well as computerized adaptive testing (CAT), often

  11. Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials

    DEFF Research Database (Denmark)

    Bottomley, Andrew; Pe, Madeline; Sloan, Jeff

    2016-01-01

    Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are anal......Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures...... are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient......-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established. This consortium, directed by the European Organisation for Research and Treatment of Cancer (EORTC), was convened to provide recommendations on how to standardise the analysis of HRQOL and other patient-reported outcomes...

  12. 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

  13. Patient reported outcomes in patients undergoing arthroscopic partial meniscectomy for traumatic or degenerative meniscal tears

    DEFF Research Database (Denmark)

    Thorlund, Jonas Bloch; Englund, Martin; Christensen, Robin

    2017-01-01

    orthopaedic departments in the Region of Southern Denmark. Participants were recruited between 1 February 2013 and 31 January 2014, and at one of the original four hospitals from 1 February 2014 to 31 January 2015. PARTICIPANTS: Individuals selected from Knee Arthroscopy Cohort Southern Denmark, aged 18...... on knee pathology. Patient reported outcomes were recorded via online questionnaires. MAIN OUTCOME MEASURES: Primary outcome was the average between-group difference in change on four of five subscales of the knee injury and osteoarthritis outcome score (KOOS). The four subscales covered pain, symptoms...

  14. Optimal timing of periodontal disease treatment for prevention of adverse pregnancy outcomes: before or during pregnancy?

    Science.gov (United States)

    Xiong, Xu; Buekens, Pierre; Goldenberg, Robert L; Offenbacher, Steven; Qian, Xu

    2011-08-01

    Several large randomized controlled clinical trials failed to find that standard periodontal therapy during pregnancy reduces the incidence of adverse pregnancy outcomes (eg, preterm birth and low birthweight). However, treating periodontal disease during pregnancy may be too late to reduce the inflammation that is related to the adverse pregnancy outcomes. Moreover, periodontal treatment during pregnancy can cause bacteremia, which itself may initiate the pathway leading to the adverse pregnancy outcomes. Finally, the periodontal treatments provided during pregnancy are not always effective in preventing the progression of periodontal disease during pregnancy. Pregnancy may not be an appropriate period for periodontal intervention(s). We hypothesize that periodontal treatment before pregnancy may reduce the rates of adverse pregnancy outcomes. Future randomized controlled trials are needed to test if treating periodontal disease in the prepregnancy period reduces the rate of adverse pregnancy outcomes. Copyright © 2011 Mosby, Inc. All rights reserved.

  15. Education attainment is associated with patient-reported outcomes: findings from the Swedish Hip Arthroplasty Register.

    Science.gov (United States)

    Greene, Meridith E; Rolfson, Ola; Nemes, Szilard; Gordon, Max; Malchau, Henrik; Garellick, Göran

    2014-06-01

    Age, sex, and medical comorbidities may be associated with differences in patient-reported outcome scores after THA. Highest level of education may be a surrogate for socioeconomic status, but the degree to which this is associated with patient-reported outcomes after THA is not known. We investigated the national Swedish Hip Arthroplasty Register for the association of education attainment on patient-reported outcomes 1 year after THA; specifically, we evaluated level of education attainment against health-related quality of life (HRQoL), pain reduction, and satisfaction with treatment 1 year after THA. All THAs for osteoarthritis performed from 2005 through 2007 with complete patient-reported outcome measures (representing 49% of the THAs performed for this diagnosis) were selected from the Swedish Hip Arthroplasty Register. These cases were merged with national databases containing education attainment, marital status, and comorbidities (n = 11,464; mean age of patients, 64 years). The patient-reported outcome measure protocol included the HRQoL measure EuroQol five-dimension scale (EQ-5D), a VAS for pain, the Charnley classification survey, and a VAS addressing THA satisfaction. Linear regression analyses determined the association of preoperative patient factors with patient-reported outcomes. High education attainment was associated with higher HRQoL (EQ-5D index ß(high) = 0.03 ± 0.01; EQ VAS ß(high) = 2.6 ± 0.5) after THA, whereas those with low and medium education were at risk for lower HRQoL. High education was associated with less pain after treatment (ß(high) = -3.3 ± 0.05). Individuals with low or medium education were at risk for less satisfaction with THA (p education to a greater extent. Identification of patients who will benefit most from THA and educating those at risk for poorer outcomes, like patients with low and medium education, ultimately may improve patient satisfaction, HRQoL, pain, and the cost utility of THA. Level III

  16. Pregnancy outcome in Norway after Chernobyl

    International Nuclear Information System (INIS)

    Irgens, L.M.; Lie, R.T.; Ulstein, M.; Skeie Jensen, T.; Skjaerven, R.; Sivertsen, F.; Reitan, J.B.; Strand, F.; Strand, T.; Egil Skjeldestad, F.

    1991-01-01

    Pregnancy outcome has been studied in terms of legal abortions, early spontaneous abortions and total number of pregnancies (in an ad hoc study covering 6 counties) as well as various perinatal health problems (on the basis of routinely recorded data for epidemiological surveillance from the Medical Birth Registry of Norway). Apparently, no effects were observed in terms of an increased occurrence of legal abortions, while spontaneous abortions increased from 2.4% of all pregnancies during the last 12 months before the accident to 3% after the accident. At the same time, the total number of pregnancies somewhat decreased. Based on monthly measurements in each municipality of external and internal (food-based) doses, dose-response associations were assessed for a number of perinatal health problems. No associations were observed

  17. Perinatal outcomes in pregnancy with asthma.

    Science.gov (United States)

    Syed, Rashid Zaheer; Zubairi, Ali Bin Sarwar; Zafar, Muhammad Ahsan; Qureshi, Rahat

    2008-09-01

    To examine the relationship between asthmatic pregnancies and selected maternal and neonatal outcomes in a representative cohort. A retrospective cohort study was conducted at the Aga Khan University Hospital during the year 2004. A random selection was made of 65 asthmatic and 63 non-asthmatic singleton births. The neonatal outcomes studied were birth weight, premature birth and Apgar scores at 1 and 5 minutes. The maternal outcomes studied were number of hospital admissions, and number of documented UTI during the studied pregnancy and past history of abortions and stillbirths. The mean age of asthmatics and nonasthmatics were 28.0 +/- 4.9 years and 27.7 +/- 3.6 years respectively. The average parity among asthmatic women was 2.97 while that in controls was 2.57 (p UTIs and hospital admissions. Asthmatic pregnancies are more likely to result in abortion, premature delivery and low birth weight babies. The asthmatic pregnancies were also linked with higher rates of maternal UTI. Thcrefore a more vigilant monitoring is required in asthmatic pregnancies.

  18. TEENAGE PREGNANCY AND ITS OBSTETRIC OUTCOME

    Directory of Open Access Journals (Sweden)

    Kudupudi Subba Rao

    2017-02-01

    Full Text Available BACKGROUND Teenage pregnancy is upcoming as one of the most important social and public health problem all over the world. In the present study, we have evaluated the maternal and foetal outcomes of teenage pregnancy in a tertiary teaching hospital over a period of one year. The objective of the study is to evaluate the maternal, foetal and neonatal outcomes of teenage pregnancy in a tertiary care teaching hospital. MATERIALS AND METHODS A retrospective study was undertaken for a period of one year at KIMS, a tertiary care teaching hospital in a rural area, where on an average 3000 deliveries per year take place. Data was retrieved from hospital records. All teenage mothers aged 13-19 years were included in the study. RESULTS In this study, 626 (18.79% cases of teenage mothers were recorded out of 3330 antenatal cases. Majority of teenagers were primigravida (79.23% and multigravida 20.76%. Antenatal care was nil or inadequate in 32% of cases. Majority of the mothers were of low socioeconomic status. Complications like pregnancy-induced hypertension (11.5%, premature onset of labour (5.75%, anaemia (23.64%, others like gestational diabetes mellitus, etc. (2.56% were noted. 25.88% underwent lower segment caesarean section, the most common indication was cephalopelvic disproportion (45.68%. 5% of babies delivered to teenage mothers had higher risk of low Apgar at 5 minutes. Neonatal morbidities like asphyxia, jaundice, respiratory distress were recorded in 14% of neonates and babies were more prone to neonatal intensive care unit admissions. CONCLUSION Teenage pregnancy was associated with high risk of pregnancy-induced hypertension, eclampsia, premature onset of labour and foetal deaths. High risk of neonatal morbidity and mortality were also seen. Adequate antenatal care reduces the adverse pregnancy outcome in these mothers.

  19. Postoperative weight bearing and patient reported outcomes at one year following tibial plateau fractures.

    Science.gov (United States)

    Thewlis, Dominic; Fraysse, Francois; Callary, Stuart A; Verghese, Viju Daniel; Jones, Claire F; Findlay, David M; Atkins, Gerald J; Rickman, Mark; Solomon, Lucian B

    2017-07-01

    Tibial plateau fractures are complex and the current evidence for postoperative rehabilitation is weak, especially related to the recommended postoperative weight bearing. The primary aim of this study was to investigate if loading in the first 12 weeks of recovery is associated with patient reported outcome measures at 26 and 52 weeks postoperative. We hypothesized that there would be no association between loading and patient reported outcome measures. Seventeen patients, with a minimum of 52-week follow-up following fragment-specific open reduction and internal fixation for tibial plateau fracture, were selected for this retrospective analysis. Postoperatively, patients were advised to load their limb to a maximum of 20kg during the first 6 weeks. Loading data were collected during walking using force platforms. A ratio of limb loading (affected to unaffected) was calculated at 2, 6 and 12 weeks postoperative. Knee Injury and Osteoarthritis Scores were collected at 6, 12, 26 and 52 weeks postoperative. The association between loading ratios and patient reported outcomes were investigated. Compliance with weight bearing recommendations and changes in the patient reported outcome measures are described. Fracture reduction and migration were assessed on plain radiographs. No fractures demonstrated any measurable postoperative migration at 52 weeks. Significant improvements were seen in all patient reported outcome measures over the first 52 weeks, despite poor adherence to postoperative weight bearing restrictions. There were no associations between weight bearing ratio and patient reported outcomes at 52 weeks postoperative. Significant associations were identified between the loading ratio at 2 weeks and knee-related quality of life at six months (R 2 =0.392), and between the loading ratio at 6 weeks combined with injury severity and knee-related quality of life at 26 weeks (R 2 =0.441). In summary, weight bearing as tolerated does not negatively affect the

  20. Impact of antiretroviral therapy on pregnancy outcomes

    Directory of Open Access Journals (Sweden)

    C D Aniji

    2013-11-01

    Objective. To examine the impact of ART on pregnancy outcome according to the timing of initiation of treatment. Methods. A retrospective cohort study was conducted among women delivering at a tertiary hospital from 1 October 2008 to 31 March 2009. Results. A total of 245 mothers were receiving ART: 76 mothers (31% started ART pre-conception and 169 mothers (69% started ART after the first trimester. No significant differences were observed in the rates of preterm delivery and low birth weight (LBW between the pre- and post-conception groups (21% v. 24% and 21% v. 25%, respectively. Conclusion. In this cohort of women receiving ART in pregnancy, timing of ART initiation did not have any adverse effect on the measured pregnancy outcomes such as preterm delivery and LBW.

  1. Fetomaternal Outcome with Hepatitis E in Pregnancy

    International Nuclear Information System (INIS)

    Yasmeen, T.; Hashmi, H.A.; Taj, A.

    2013-01-01

    Objective: To assess the maternal morbidity and mortality and fetal outcome with hepatitis E (HEV) in pregnancy. Study Design: Cross-sectional study. Place and Duration of Study: Liaquat National Hospital, Karachi, from May 2008 to April 2010. Methodology: Thirty patients admitted at Gynae Ward with serologically proven HEV in pregnancy were included in the study. All these patients were followed during their hospital stay with liver function tests and coagulation profile. Maternal morbidity and mortality and fetal outcome were recorded. Results: Maximum maternal morbidities were noted in patients who presented in 3rd trimester, both clinically and derangement of haematological and biochemical tests. Out of 30 patients, 08 patients expired with maternal mortality rate of 29.3% and rest were discharged safely. Perinatal mortality rate was 30.3 per 1000 live births. Conclusion: Hepatitis E runs a fulminant course during pregnancy with very high mortality rate especially during third trimester and postpartum period. (author)

  2. Pregnancy outcome of systemic lupus erythematosus in relation to lupus activity before and during pregnancy

    Directory of Open Access Journals (Sweden)

    Ming-Jie Yang

    2015-04-01

    Conclusion: In order to reduce the incidence of pregnancy complication, especially preterm delivery, and to gain good pregnancy outcome, good preparation before conception and good control of the disease during pregnancy are mandatory.

  3. 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.

  4. 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.

  5. Pregnancy outcomes after chemotherapy for trophoblastic neoplasia.

    Science.gov (United States)

    Garcia, Mila Trementosa; Lin, Lawrence Hsu; Fushida, Koji; Francisco, Rossana Pulcineli Vieira; Zugaib, Marcelo

    2016-12-01

    The successful development of chemotherapy enabled a fertilitysparing treatment for patients with trophoblastic neoplasia. After disease remission, the outcome of a subsequent pregnancy becomes a great concern for these women. To analyze existing studies in the literature that describe the reproductive outcomes of patients with trophoblastic neoplasia treated with chemotherapy. Systematic review was performed searching for articles on Medline/ Pubmed, Lilacs and Cochrane Library databases, using the terms "gestational trophoblastic disease" and "pregnancy outcome". A total of 18 articles were included. No evidence of decreased fertility after chemotherapy for trophoblastic neoplasia was observed. The abortion rates in patients who conceived within 6 months after chemotherapy was higher compared to those who waited longer. Some studies showed increased rates of stillbirth and repeat hydatidiform moles. Only one work showed increased congenital abnormalities. The pregnancies conceived after chemotherapy for trophoblastic neoplasia should be followed with clinical surveillance due to higher rates of some pregnancy complications. However, studies in the literature provide reassuring data about reproductive outcomes of these patients.

  6. Adolescent smoking in pregnancy and birth outcomes

    NARCIS (Netherlands)

    Delpisheh, Ali; Attia, Eman; Drammond, Sandra; Brabin, Bernard J.

    2006-01-01

    INTRODUCTION: Cigarette smoking amongst pregnant adolescents is a preventable risk factor associated with low birthweight ( <2,500 g), preterm birth ( <37 weeks) and infant mortality. The aim of this study was to compare birth outcomes of adolescents who smoke during pregnancy with those who do not

  7. Rationale for Using Social Media to Collect Patient-Reported Outcomes in Patients with Celiac Disease.

    Science.gov (United States)

    Park, Kt; Harris, Merissa; Khavari, Nasim; Khosla, Chaitan

    2014-02-01

    Patients with celiac disease (CD) are increasingly interconnected through social media, exchanging patient experiences and health-tracking information between individuals through various web-based platforms. Social media represents potentially unique communication interface between gastroenterologists and active social media users - especially young adults and adolescents with celiac disease-regarding adherence to the strict gluten-free diet, gastrointestinal symptoms, and meaningful discussion about disease management. Yet, various social media platforms may be underutilized for research purposes to collect patient-reported outcomes data. In this commentary, we summarize the scientific rationale and potential for future growth of social media in patient-reported outcomes research, focusing on college freshmen with celiac disease as a case study and provide overview of the methodological approach. Finally, we discuss how social media may impact patient care in the future through increasing mobile technology use.

  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. Pregnancy outcome after fetal reduction in women with a dichorionic twin pregnancy

    NARCIS (Netherlands)

    van de Mheen, L.; Everwijn, S. M. P.; Knapen, M. F. C. M.; Haak, M. C.; Engels, M. A. J.; Manten, G. T. R.; Zondervan, H. A.; Wirjosoekarto, S. A. M.; van Vugt, J. M. G.; Erwich, J. J. H. M.; Bilardo, C. M.; van Pampus, M. G.; de Groot, C. J. M.; Mol, B. W. J.; Pajkrt, E.

    STUDY QUESTION: What are the pregnancy outcomes for women with a twin pregnancy that is reduced to a singleton pregnancy? summary answer: Fetal reduction of a twin pregnancy significantly improves gestational age at birth and neonatal birthweight, however at an increased risk of pregnancy loss and

  10. Pregnancy outcome after fetal reduction in women with a dichorionic twin pregnancy

    NARCIS (Netherlands)

    van de Mheen, L; Everwijn, S M P; Knapen, M F C M; Haak, M C; Engels, M A J; Manten, G T R; Zondervan, H A; Wirjosoekarto, S A M; van Vugt, J M G; Erwich, J J H M; Bilardo, C M; van Pampus, M G; de Groot, C J M; Mol, B W J; Pajkrt, E

    STUDY QUESTION: What are the pregnancy outcomes for women with a twin pregnancy that is reduced to a singleton pregnancy? SUMMARY ANSWER: Fetal reduction of a twin pregnancy significantly improves gestational age at birth and neonatal birthweight, however at an increased risk of pregnancy loss and

  11. Patient-reported outcomes in adult survivors with single-ventricle physiology

    DEFF Research Database (Denmark)

    Overgaard, Dorthe; Schrader, Anne-Marie; Lisby, Karen H

    2011-01-01

    Objectives: Data on patient-reported outcomes (PROs) in patients with single-ventricle physiology (SVP) are scarce. We sought (1) to describe the perceived health status, quality of life, symptoms of anxiety and depression, and sense of coherence in adult survivors with SVP, (2) to compare PROs a...... of perceived health and quality of life. For patients in Ability Index class II and III, PROs were poorer. Conclusions: PROs in patients with SVP are generally good....

  12. Development of a patient-reported outcome instrument for patients with lumbar radicular pain

    OpenAIRE

    Ibsen, Charlotte; Schiøttz-Christensen, Berit; Handberg, Charlotte; Nielsen, Claus Vinther; Hørder, Mogens; Maribo, Thomas

    2017-01-01

    Background Low back pain (LBP) is the leading cause to years lived with disability. 10–20% of patients with LBP experience radicular pain (lumbar radiculopathy). Patient-reported outcomes (PROs) play an important role in advancing patient-centered health care. Although patient involvement is essential to develop valid patient-centred PRO instruments patients are not always involved. The International Classification of Functioning, Disability and Health (ICF) are proposed to facilitate consist...

  13. 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...

  14. Obstetric and perinatal outcome of multiple pregnancy

    International Nuclear Information System (INIS)

    Qazi, G.

    2011-01-01

    To determine the obstetric and perinatal outcome in multiple pregnancies at a teaching hospital. The analysis included data on all women between 20 and 35 years of age with 24 completed weeks gestation having multiple pregnancies during the study period after applying the exclusion criteria. The data retrieved from the hospital-based maternal health medical records included demographic details, complications of pregnancy, and maternal and neonatal outcomes. The data was expressed as frequencies, percentages, mean and standard deviation. Normal distribution of continuous variables was determined by Shapiro Wilk test. The differences in the mean birth weight of the first and second twin were compared by student's t-test considering a p-value less than 0.05 as statistically significant. There were a total of 161 multiple pregnancies with the overall incidence of 37.1 per 1,000 births (3.2%) during the study period. One hundred and twenty two cases had the inclusion criteria applicable. There were 9 triplets among these of whom seven were received as intrauterine death and the other two were lost to follow-up. The four leading maternal adverse outcomes were anemia (74.6%), preterm delivery (31%), pregnancy - induced hypertension (30%) and preterm premature rupture of membranes (26.2%). Median gestational age at delivery was 37 weeks. Most common route of delivery was caesarean section (53.3%). Most common neonatal complication was low birth weight. Prematurity was the most common cause of neonatal death. Multiple pregnancy have high maternal and neonatal complications, especially preterm delivery that increases risk of significant neonatal morbidity and mortality. (author)

  15. 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 .

  16. Maternal periodontal disease, pregnancy, and neonatal outcomes.

    Science.gov (United States)

    Dasanayake, Ananda P; Gennaro, Susan; Hendricks-Muñoz, Karen D; Chhun, Nok

    2008-01-01

    The purpose of this article is to review the current literature on the association between maternal periodontal disease and poor pregnancy and neonatal outcomes and outline the role nurses can play in improving the oral health of pregnant women. Maternal periodontal disease is linked to preterm birth, low birthweight, and preterm low birthweight, but treatment of periodontal disease during pregnancy has been shown to be safe and effective. Nurses, nurse practitioners, and nurse-midwives are in a position to educate pregnant women on the benefits of good oral health and identify and refer women who are in need of dental care for treatment.

  17. Pregnancy outcomes after chemotherapy for trophoblastic neoplasia

    Directory of Open Access Journals (Sweden)

    MILA TREMENTOSA GARCIA

    Full Text Available SUMMARY Introduction The successful development of chemotherapy enabled a fertilitysparing treatment for patients with trophoblastic neoplasia. After disease remission, the outcome of a subsequent pregnancy becomes a great concern for these women. Objective To analyze existing studies in the literature that describe the reproductive outcomes of patients with trophoblastic neoplasia treated with chemotherapy. Method Systematic review was performed searching for articles on Medline/ Pubmed, Lilacs and Cochrane Library databases, using the terms “gestational trophoblastic disease” and “pregnancy outcome”. Results A total of 18 articles were included. No evidence of decreased fertility after chemotherapy for trophoblastic neoplasia was observed. The abortion rates in patients who conceived within 6 months after chemotherapy was higher compared to those who waited longer. Some studies showed increased rates of stillbirth and repeat hydatidiform moles. Only one work showed increased congenital abnormalities. Conclusion The pregnancies conceived after chemotherapy for trophoblastic neoplasia should be followed with clinical surveillance due to higher rates of some pregnancy complications. However, studies in the literature provide reassuring data about reproductive outcomes of these patients.

  18. Pregnancy outcome in type 1 diabetic women with microalbuminuria

    DEFF Research Database (Denmark)

    Ekbom, P; Damm, P; Feldt-Rasmussen, B

    2001-01-01

    To determine the influence of microalbuminuria on pregnancy outcome in women with type 1 diabetes.......To determine the influence of microalbuminuria on pregnancy outcome in women with type 1 diabetes....

  19. 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

  20. 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...

  1. Admission Test and Pregnancy Outcome

    Directory of Open Access Journals (Sweden)

    Setareh Akhavan

    2017-07-01

    Full Text Available Background: The admission test (AT has been carried out for many years, but there are still debates about the prognostic value of the test. Therefore, we aimed to examine the value of the AT in predicting the adverse outcome in neonates. Methods: In this cross-sectional study, 425 pregnant women with normal vaginal delivery were studied between2009 and 2014at Vali-e-Asr Hospital. Based on the results, the women were divided into 2groups of normal and abnormal ATs. All the patients were followed up until the birth of their baby, when the status of mother and neonate was determined. The main outcomes of the study were cesarean rate, neonatal intensive care unit (NICU admission, fetus demise, neonatal acidosis, and Apgar score. The independent t-test, chi-square test, Fisher exact test, and logistic regression were used for statistical analysis. The data were analyzed using SPSS (version 17. Results: Of 425 pregnant women studied, 142 (33.4% had abnormal ATs with a mean age of 29 (±4.5 years. Multivariate analysis showed that an abnormal AT was able to predict the incidence of cesarean section, intrauterine growth restriction, turned cord, and Apgar<7, but it could not predict neonatal death and hypoxia. Conclusion: The AT was shown to be a useful screening test with risk factors such as oligohydramnios, bloody amniotic fluid, meconium amniotic fluid, intrauterine growth restriction, and turned cord. Additionally, the test was also able to predict NICU admission and the need for cesarean section, but it could not predict the occurrence of neonatal death.

  2. Montreal Accord on Patient-Reported Outcomes (PROs) use series - Paper 8: patient-reported outcomes in electronic health records can inform clinical and policy decisions.

    Science.gov (United States)

    Ahmed, Sara; Ware, Patrick; Gardner, William; Witter, James; Bingham, Clifton O; Kairy, Dahlia; Bartlett, Susan J

    2017-09-01

    Given that the goal of health care systems is to improve and maintain the health of the populations they serve, the indicators of performance must include outcomes that are meaningful to patients. The growth of health technologies provides an unprecedented opportunity to integrate the patient voice into clinical care by linking electronic health records (EHRs) to patient-reported outcome (PRO) data collection. However, PRO data must be relevant, meaningful, and actionable for those who will have to invest the time and effort to collect it. In this study, we highlight opportunities to integrate PRO data collection into EHRs. We consider how stakeholder perspectives should influence the selection of PROs and ways to enhance engagement in and commitment to PRO implementation. We propose a research and policy agenda to address unanswered questions and facilitate the widespread adoption of PRO data collection into EHRs. Building a learning health care system that gathers PRO data in ways that can inform individual patient care, quality improvement, and comparative effectiveness research has the potential to accelerate the application of new evidence and knowledge to patient care. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. Patient-Reported Outcomes in Patients with Chronic Kidney Disease and Kidney Transplant—Part 1

    Directory of Open Access Journals (Sweden)

    Evan Tang

    2018-01-01

    Full Text Available Chronic kidney disease (CKD is a complex medical condition that is associated with several comorbidities and requires comprehensive medical management. Given the chronic nature of the condition, its frequent association with psychosocial distress, and its very significant symptom burden, the subjective patient experience is key toward understanding the true impact of CKD on the patients’ life. Patient-reported outcome measures are important tools that can be used to support patient-centered care and patient engagement during the complex management of patients with CKD. The routine collection and use of patient-reported outcomes (PROs in clinical practice may improve quality of care and outcomes, and may provide useful data to understand the disease from both an individual and a population perspective. Many tools used to measure PROs focus on assessing health-related quality of life, which is significantly impaired among patients with CKD. Health-related quality of life, in addition to being an important outcome itself, is associated with clinical outcomes such as health care use and mortality. In Part 1 of this review, we provide an overview of PROs and implications of their use in the context of CKD. In Part 2, we will review the selection of appropriate measures and the relevant domains of interest for patients with CKD.

  4. Persistent ovarian masses and pregnancy outcomes.

    Science.gov (United States)

    Goh, William A; Rincon, Monica; Bohrer, Justin; Tolosa, Jorge E; Sohaey, Roya; Riaño, Rene; Davis, James; Zalud, Ivica

    2013-07-01

    To determine if persistent ovarian masses in pregnancy are associated with increased adverse outcomes. This is a retrospective cohort of 126 pregnant women with a persistent ovarian mass measuring 5 cm or greater who delivered at two university hospitals between 2001 and 2009. Maternal outcomes included gestational age (GA) at diagnosis, delivery and surgery as well as miscarriage, preterm birth (PTB), ovarian torsion and hospital admission for pain. Neonatal outcomes included birth weight, respiratory distress syndrome (RDS), intra-ventricular hemorrhage (IVH), death and sepsis. A total of 1225 ovarian masses were identified (4.9%) in 24,868 patients. A persistent ovarian mass was found in 0.7%. Average GA at diagnosis was 17.8 weeks. Miscarriage rate was 3.3%. Average GA at delivery was 37.9 weeks. Of the patients, 8.5% had ovarian torsion, 10.3% had admission for pain and 9.3% had PTBs. The mean cesarean delivery rate was 46.3%. The average neonatal weight was 3273 g. There was one neonatal death in this cohort. The rate of RDS was 2.8%, IVH 0.9% and neonatal sepsis 1.9%. The most common surgical pathologic diagnosis was dermoids (37.6%). No overt malignancies were seen. A persistent ovarian mass in pregnancy does not confer an increased risk of adverse pregnancy outcomes.

  5. Outcomes in type 1 diabetic pregnancies

    DEFF Research Database (Denmark)

    Jensen, Dorte Møller; Damm, Peter; Moelsted-Pedersen, Lars

    2004-01-01

    OBJECTIVE: The aim of this study was to compare pregnancy outcomes in type 1 diabetic pregnancies with the background population. RESEARCH DESIGN AND METHODS: This nationwide prospective multicenter study took place in eight Danish centers treating pregnant women with type 1 diabetes during 1993...... mortality rate was 3.1% in type 1 diabetic pregnancies compared with 0.75% in the background population (RR 4.1 [95% CI 2.9-5.6]), and the stillbirth rate was 2.1% compared with 0.45 (4.7 [3.2-7.0]). The congenital malformation rate was 5.0% in the study population and 2.8% (1.7 [1.3-2.2]) in the background......, daily self-monitoring was associated with a reduction in serious adverse outcomes. The caesarean section rate was 55.9 and 12.6%, respectively, and the risk of preterm delivery was 41.7 and 6.0%, respectively. CONCLUSIONS: Type 1 diabetic pregnancies are still complicated by considerably higher rates...

  6. Pregnancy outcome in women with endometriosis achieving pregnancy with IVF.

    Science.gov (United States)

    Benaglia, Laura; Candotti, Giorgio; Papaleo, Enrico; Pagliardini, Luca; Leonardi, Marta; Reschini, Marco; Quaranta, Lavinia; Munaretto, Maria; Viganò, Paola; Candiani, Massimo; Vercellini, Paolo; Somigliana, Edgardo

    2016-12-01

    Are women with endometriosis who conceive with IVF at increased risk of preterm birth? Women with endometriosis who conceive with IVF do not face an increased risk of preterm birth. The eutopic endometrium of women with endometriosis has been repeatedly shown to present molecular and cellular alterations. On this basis, it has been hypothesized that pregnancy outcome may be altered in affected women. However, to date, available evidence from epidemiological studies is scanty and conflicting. Data tended to be partly consistent only for an increased risk of preterm birth and placenta previa. Retrospective matched case-control study of women achieving an IVF singleton pregnancy progressing beyond 12 weeks' gestation. Women achieving IVF singleton pregnancies that progressed beyond 12 weeks' gestation at two infertility units were reviewed. Cases were women with a history of surgery for endometriosis and/or with a sonographic diagnosis of the disease at the time of the IVF cycle. Controls were women without current or past evidence of endometriosis who were matched to cases by age (± 6 months), type of cycle (fresh or frozen cycle) and study period. Male factor and unexplained infertility were the most common diagnoses in the control group. Two hundred and thirty-nine women with endometriosis and 239 controls were selected. The main outcome of the study was the rate of preterm birth (birth IVF pregnancies only, and specific data from properly designed studies are required to support any inference for natural pregnancies. The results of our study suggest that women with endometriosis conceiving with IVF can be reassured regarding the risk of preterm birth. The observed association with placenta previa requires further investigation and may open a new avenue of research. No external funding was used for this study. None of the authors have any conflict of interest to declare. © The Author 2016. Published by Oxford University Press on behalf of the European Society

  7. 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...

  8. Patient-Reported Outcome questionnaires for hip arthroscopy: a systematic review of the psychometric evidence

    Science.gov (United States)

    2011-01-01

    Background Hip arthroscopies are often used in the treatment of intra-articular hip injuries. Patient-reported outcomes (PRO) are an important parameter in evaluating treatment. It is unclear which PRO questionnaires are specifically available for hip arthroscopy patients. The aim of this systematic review was to investigate which PRO questionnaires are valid and reliable in the evaluation of patients undergoing hip arthroscopy. Methods A search was conducted in Pubmed, Medline, CINAHL, the Cochrane Library, Pedro, EMBASE and Web of Science from 1931 to October 2010. Studies assessing the quality of PRO questionnaires in the evaluation of patients undergoing hip arthroscopy were included. The quality of the questionnaires was evaluated by the psychometric properties of the outcome measures. The quality of the articles investigating the questionnaires was assessed by the COSMIN list. Results Five articles identified three questionnaires; the Modified Harris Hip Score (MHHS), the Nonarthritic Hip Score (NAHS) and the Hip Outcome Score (HOS). The NAHS scored best on the content validity, whereas the HOS scored best on agreement, internal consistency, reliability and responsiveness. The quality of the articles describing the HOS scored highest. The NAHS is the best quality questionnaire. The articles describing the HOS are the best quality articles. Conclusions This systematic review shows that there is no conclusive evidence for the use of a single patient-reported outcome questionnaire in the evaluation of patients undergoing hip arthroscopy. Based on available psychometric evidence we recommend using a combination of the NAHS and the HOS for patients undergoing hip arthroscopy. PMID:21619610

  9. TEENAGE PREGNANCY: DEMOGRAPHICS, MATERNAL AND FOETAL OUTCOME

    Directory of Open Access Journals (Sweden)

    Radhika Gollapudi

    2016-08-01

    Full Text Available BACKGROUND Pregnancy though is a physiological event in a woman’s life, it has its own associated complications. In teenage pregnancies, the physical and emotional state of stress coupled with biological immaturity leads to adverse effect both on the health of the mother and the foetus. METHODS This study is a clinical prospective study analysing the demographics, maternal health issues and the foetal outcome in teenage pregnancies. The study was conducted over a period of one year at a government tertiary care center. Pregnant women in the age group of 13-19 years who delivered during the study period were included in the study group. All pregnant women over 20 years of age who delivered during the same period were taken as control group. Women who had medical disorders complicating pregnancy were excluded from the study. Anaemia, pregnancy induced hypertension, antepartum haemorrhage and mode of delivery were the maternal outcomes that were noted. Intrauterine growth retardation, prematurity, low birth weight, APGAR score were analysed with respect to the foetus. RESULTS In this study, the total number of pregnant women who delivered during the study period were 4782, 536 were teenage mothers, constituting 11.2% of the total pregnancies. Of the 536 teenage mothers, 69.78% belonged to the rural areas and 71.64% were found to have inadequate antenatal visits to the hospital. The mean age of teenage pregnancy was 17.18 years. Incidence of anaemia was 44.2% in comparison, the control group had an incidence of 33.02%. In our study, incidence of Pregnancy induced hypertension was 18.64% in teenage mothers and 10.6% in non-teenage mothers. The incidence of Antepartum Haemorrhage in our study was 8.94% in teenage mothers. Incidence of lower segment caesarean section was 22.76% in the teenage group as compared to 14.57% in the non-teenage group. In our study, 13.05% of teenage mothers had preterm deliveries as compared to 6.40% of non-teenage mothers

  10. Outcome of pregnancy complicated by threatened abortion.

    Science.gov (United States)

    Dongol, A; Mool, S; Tiwari, P

    2011-01-01

    Threatened abortion is the most common complication in the first half of pregnancy. Most of these pregnancies continue to term with or without treatment. Spontaneous abortion occurs in less than 30% of these women. Threatened abortion had been shown to be associated with increased incidence of antepartum haemorrhage, preterm labour and intra uterine growth retardation. This study was to asses the outcome of threatened abortion following treatment. This prospective study was carried out in Dhulikhel Hospital - Kathmandu University Hospital from January 2009 till May 2010. Total 70 cases of threatened abortion were selected, managed with complete bed rest till 48 hrs of cessation of bleeding, folic acid supplementation, uterine sedative, and hormonal treatment till 28 weeks of gestation. Ultrasonogram was performed for diagnosis and to detect the presence of subchorionic hematoma. Patients were followed up until spontaneous abortion or up to delivery of the fetus. The measures used for the analysis were maternal age, parity, gestational age at the time of presentation, previous abortions, presence of subchorionic hematoma, complete abortion, continuation of pregnancy, antepartum hemorrhage, intrauterine growth retardation and intrauterine death of fetus. Out of 70 cases subchorionic haematoma was found in 30 (42.9%) cases. There were 12 (17.1%) patients who spontaneously aborted after diagnosis of threatened abortion during hospital stay, 5 (7.1%) aborted on subsequent visits while 53 (75.8%) continued pregnancy till term. Among those who continued pregnancy intrauterine growth retardation was seen in 7 (13.2%), antepartum hemorrhage in 4 (7.5%), preterm premature rupture of membrane in 3 (5.66%) and IUD in 3 (5.66%). Spontaneous abortion was found more in cases with subchorionic hematoma of size more than 20 cm2. In cases of threatened abortion with or without the presence of subchorionic hematoma, prognostic outcome is better following treatment with bed rest

  11. Perinatal Outcomes in Advanced Age Pregnancies

    Directory of Open Access Journals (Sweden)

    Ertuğrul Yılmaz

    2016-06-01

    Full Text Available Objective: The aim of this study is to evaluate the impact of advanced maternal age on pregnancy outcomes Methods: A retrospective analysis of 951 birth registry records of Zeynep Kamil Hospital, were analyzed between Janu­ary 2003 and December 2007. Study group was made up of women ≥40 years old and control group was made up of women younger than 40 years. Results: Mean maternal age was 41.48 years in the study group and 26.41 years in the control group. Mean gesta­tional age at the time of delivery is 37.73 weeks in study group and 38.10 weeks in the control group. There was no statistical difference in terms of preterm delivery, multiple pregnancy, fetal anomaly, IUGR, superimpose preeclampsia oligohidramnios, presentation anomaly and placenta previa rates between the study and control groups. Incidence of preeclampsia (p=0.041, Chronic hypertension (p=0.001, GDM (p= 0.003,is found to be higher in study group. Cesar­ean birth rate is higher (p<0.05 and hospitalization time is longer in study group (p=0.001. 1st minute and 5th minute APGAR scores of the study group (6.99±2, 8.27±2 was lower than the 1st minute and 5th Minutes APGAR scores of the control group (7.38±1.6, 8.58±1.7. Neonatal intensive care unit administration rate is seen also higher in study group (p<0.01. Conclusion: Advanced maternal age was related to increased pregnancy complications and poor perinatal outcome. Preeclampsia, GDM, chronic hypertension is seen more common in advanced age pregnancies. Neonatal intensive care administration is higher and APGAR scores are lower; cesarean delivery was performed more common, and hospitaliza­tion time was longer in advanced age pregnancies. J Clin Exp Invest 2016; 7 (2: 157-162

  12. Montreal Accord on Patient-Reported Outcomes (PROs) use series - Paper 9: anonymization and ethics considerations for capturing and sharing patient reported outcomes.

    Science.gov (United States)

    Arbuckle, Luk; Moher, Ester; Bartlett, Susan J; Ahmed, Sara; El Emam, Khaled

    2017-09-01

    Patient-reported outcomes (PROs) are collected with consent for care; however, using the data for any other purpose requires consent for that additional purpose, or the anonymization of the data. Collecting explicit consent to use this data for secondary purposes, before the patient completes a PRO, can also bias the responses. We consider the ethical and security issues related to the collection of data at the point of care or in the population and the aggregation and integration of PRO data with administrative databases to facilitate decision making and comparative effectiveness research. In this article, we describe risk-based anonymization, taking the context of the data release into account, so that we may consider the degree by which the release is considered anonymized. We also consider the ethical use of anonymized data, the anonymization of free-form text, and the secure linking data sets without sharing any personal information. Many good standards and best practices exist for the sharing of health data and could be used as a baseline in the development of a national PRO initiative. Copyright © 2017 Elsevier Inc. All rights reserved.

  13. Montreal Accord on Patient-Reported Outcomes (PROs) use series - Paper 3: patient-reported outcomes can facilitate shared decision-making and guide self-management.

    Science.gov (United States)

    Noonan, Vanessa K; Lyddiatt, Anne; Ware, Patrick; Jaglal, Susan B; Riopelle, Richard J; Bingham, Clifton O; Figueiredo, Sabrina; Sawatzky, Richard; Santana, Maria; Bartlett, Susan J; Ahmed, Sara

    2017-09-01

    There is a shift toward making health care patient centered, whereby patients are part of medical decision-making and take responsibility for managing their health. Patient-reported outcomes (PROs) capture the patient voice and can be used to engage patients in medical decision-making. The objective of this paper is to present important factors from patients', clinicians', researchers', and decision-makers' perspectives that influence successful adoption of PROs in clinical practice. Factors recommended in this paper were informed by a patient partner. Based on themes arising from the Montreal Accord proceedings, we describe factors that influence the adoption of PROs and how PROs can have a positive effect by enhancing communication and providing opportunities to engage patients, carers, and clinicians in care. Consideration of patient factors (e.g., health literacy), family support and networks (e.g., peer-support networks), technology (e.g., e-health), and health care system factors (e.g., resources to implement PROs) is necessary to ensure PROs are successfully adopted. PRO evaluation plans most likely to succeed over the long term are those incorporating PROs identified by patients as necessary for self-management and that coincide with providers' needs for collaboratively developing treatment plans with patients and families. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. Pregnancy outcome in women with polycystic ovary syndrome

    OpenAIRE

    Nivedhitha V. S.; Sankareswari R.

    2015-01-01

    Background: To compare the pregnancy outcome in polycystic ovary syndrome (PCOS) women with normal women and to study the incidence of pregnancy complications like spontaneous abortions, preterm labour, gestational diabetes, gestational hypertension, preeclampsia, pregnancy and neonatal outcome in women with PCOS. Methods: Prospective comparative study done on 160 pregnant women to compare the pregnancy outcome in PCOS and normal women. All patients were subjected to detailed history, gen...

  15. Laparoscopic Heller Myotomy vs Per Oral Endoscopic Myotomy: Patient-Reported Outcomes at a Single Institution.

    Science.gov (United States)

    Hanna, Andrew N; Datta, Jashodeep; Ginzberg, Sara; Dasher, Kevin; Ginsberg, Gregory G; Dempsey, Daniel T

    2018-04-01

    Although laparoscopic Heller myotomy (LHM) has been the standard of care for achalasia, per oral endoscopic myotomy (POEM) has gained popularity as a viable alternative. This retrospective study aimed to compare patient-reported outcomes between LHM and POEM in a consecutive series of achalasia patients with more than 1 year of follow-up. We reviewed demographic and procedure-related data for patients who underwent either LHM or POEM for achalasia between January 2011 and May 2016. Phone interviews were conducted assessing post-procedure achalasia symptoms via the Eckardt score and achalasia severity questionnaire (ASQ). Demographics, disease factors, and survey results were compared between LHM and POEM patients using univariate analysis. Significant predictors of procedure failure were analyzed using univariate and multivariate analysis. There were no serious complications in 110 consecutive patients who underwent LHM or POEM during the study period, and 96 (87%) patients completed phone surveys. There was a nonsignificant trend toward better patient-reported outcomes with POEM. There were significant differences in patient characteristics including sex, achalasia type, mean residual lower esophageal pressure (rLESP), and follow-up time. The only univariate predictors of an unsatisfactory Eckardt score or ASQ were longer follow-up and lower rLESP, with follow-up length being the only predictor on multivariate analysis. There were significant demographic and clinical differences in patient selection for POEM vs LHM in our group. Although the 2 procedures have similar patient-reported effectiveness, subjective outcomes seem to decline as a result of time rather than procedure type. Copyright © 2018 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

  16. Pregnancy outcomes after assisted human reproduction.

    Science.gov (United States)

    Okun, Nanette; Sierra, Sony

    2014-01-01

    To review the effect of assisted human reproduction (AHR) on perinatal outcomes, to identify areas requiring further research with regard to birth outcomes and AHR, and to provide guidelines to optimize obstetrical management and counselling of prospective Canadian parents. This document compares perinatal outcomes of different types of AHR pregnancies with each other and with those of spontaneously conceived pregnancies. Clinicians will be better informed about the adverse outcomes that have been documented in association with AHR, including obstetrical complications, adverse perinatal outcomes, multiple gestations, structural congenital abnormalities, chromosomal abnormalities, and imprinting disorders. Published literature was retrieved through searches of MEDLINE and the Cochrane Library from January 2005 to December 2012 using appropriate controlled vocabulary and key words (assisted reproduction, assisted reproductive technology, ovulation induction, intracytoplasmic sperm injection, embryo transfer, and in vitro fertilization). Results were not restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies; studies of all designs published in English from January 2005 to December 2012 were reviewed, and additional publications were identified from the bibliographies of these articles. Searches were updated on a regular basis and incorporated in the guideline to August 2013. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table 1). Summary Statements 1. There is increasing evidence that infertility or subfertility is an

  17. 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.

  18. Obstetric and perinatal outcome of teenage pregnancy.

    Science.gov (United States)

    Suwal, A

    2012-01-01

    Adolescents are at higher risk during childbirth than women between 20 to 25 years. Adolescent childbearing initiates a syndrome of failure: failure to complete one's education; failure in limiting family size; failure to establish a vocation and become independent. This study was done to find out the obstetric and perinatal outcome of teenage pregnancy along with factors contributing to teenage pregnancy. A prospective, cross sectional study was carried out in College of Medical Sciences Teaching Hospital (CMSTH), Bharatpur during the period for two years from September 2008 to August 2010. Pregnant girls ≤19 years admitted to labour ward were taken for the study. Cases planned for abortion and MTP were also taken. One hundred cases of pregnant teenagers were admitted in CMSTH during a period of two years. Incidence was 6.85%. In our study, most of the teenagers were unbooked, from low socioeconomic status and with no or inadequate education. They had little knowledge about contraception and less number of teenagers used temporary means of contraception. Because of our social custom of early marriage, most of the teenage mothers were married. All these factors were correlated with teenage pregnancy in present study. This study failed to show any statistically significant difference in the incidence of anaemia, LBW babies, preterm delivery, hypertensive disorder of pregnancy, mode of delivery in different ages of teenage mothers. However, there was significant difference in the incidence of perinatal death in different ages of teenage mothers indicating that perinatal deaths were more in younger teenagers.

  19. 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.

  20. Development of a patient-reported outcome instrument for patients with lumbar radicular pain

    DEFF Research Database (Denmark)

    Ibsen, Charlotte; Schiøttz-Christensen, Berit; Handberg, Charlotte

    and ICF Rehabilitation Set. Items in the ICF-PRO are developed within methods and terminology of The Patient-Reported Outcomes Measurement Information System (PROMIS®). The development process contains five phases (figure 1). Results This poster presents preliminary results from phase 1-3. 89...... the focus group identified three themes: 'Simplicity', 'Application' and 'Individuality' representing elements of most importance for the patients toward a patient centered consultation (figure 2). Conclusions We found that ‘Simplicity’, ‘Application’ and ‘Individuality’ was essential to patients to lead...

  1. Feasibility of 4 patient-reported outcome measures in a registry setting

    DEFF Research Database (Denmark)

    Paulsen, Aksel; Pedersen, Alma Becic; Overgaard, Søren

    2012-01-01

    Background and purpose Feasibility is an important parameter when choosing which patient-reported outcomes (PRO) to use in a study. We assessed the feasibility of PROs in a hip registry setting. Methods Primary total hip arthroplasty (THA) patients (n = 5,747) who had been operated on 1-2, 5.......1% to 46%, respectively. Missing items ranged from 1.2% to 3.4%, and 0.8-4.3% required manual validation (p analysis, depending on descriptive factor and choice of PRO. Interpretation All 4 PROs fulfilled...

  2. Case-mix & patients' reports of outcome in Independent Sector Treatment Centres: Comparison with NHS providers.

    Science.gov (United States)

    Browne, John; Jamieson, Liz; Lewsey, Jim; van der Meulen, Jan; Copley, Lynn; Black, Nick

    2008-04-09

    There has been considerable concern expressed about the outcomes achieved in Independent Sector Treatment Centres (ISTCs) introduced in England since 2003. Our aim was to compare the case-mix and patients' reported outcomes of surgery in ISTCs and in NHS providers. Prospective cohort study of 769 patients treated in six ISTCs and 1895 treated in 20 NHS providers (acute hospitals and treatment centres) in England during 2006-07. Participants underwent one of three day surgery procedures (inguinal hernia repair, varicose vein surgery, cataract extraction) or hip or knee replacement. Change in patient-reported health status and health related quality of life (measured using a disease-specific and a generic (EQ-5D) instrument) was assessed either 3-months (day surgery) or 6-months (hip/knee) after surgery. In addition patient-reported post-operative complications and an overall assessment of success of surgery were collected. Outcome measures were adjusted (using multivariable regression) for patient characteristics (disease severity, duration of symptoms, age, sex, socioeconomic status, general health, previous similar surgery, comorbidity). Post-operative response rates varied by procedure (73%-88%) and were similar for those treated in ISTCs and NHS facilities. Patients treated in ISTCs were healthier, were less likely to have any comorbidity and, for those undergoing cataract surgery or joint replacement, their primary condition was less severe. Those undergoing hernia repair or joint replacement were less likely to have had similar surgery before. When adjustment was made for pre-operative characteristics, patients undergoing cataract surgery or hip replacement in ISTCs achieved a slightly greater improvement in functional status and quality of life than those treated in NHS facilities, while the opposite was true of patients undergoing hernia repair. No significant differences were found for the two other procedures. Patients treated in ISTCs were less likely to

  3. Are validated patient-reported outcomes used on children in pediatric otolaryngology? A systematic review.

    Science.gov (United States)

    Wong, Kevin; Piraquive, Jacquelyn; Troiano, Chelsea A; Sulibhavi, Anita; Grundfast, Kenneth M; Levi, Jessica R

    2018-02-01

    Review the pediatric otolaryngology literature to 1) identify studies in which children completed patient-reported outcome (PRO) measures and 2) appraise the psychometric quality and validity of these PROs as they apply to pediatrics. In October 2016, a systematic review was performed by two reviewers on PubMed/MEDLINE and EMBASE for all otolaryngology-related studies that utilized PROs in children. Inclusion criteria included articles that required children (ageotolaryngology and some studies utilized PROs that were not validated or not validated for use in this age group. Future efforts to design and validate more instruments may be warranted. Copyright © 2017. Published by Elsevier B.V.

  4. Patient-Reported Outcomes and Fatigue in Patients with Chronic Hepatitis C Infection.

    Science.gov (United States)

    Golabi, Pegah; Sayiner, Mehmet; Bush, Haley; Gerber, Lynn H; Younossi, Zobair M

    2017-08-01

    Fatigue is a common symptom. Diagnosis is difficult. Fatigue is often a complex symptom. In the recent years, fatigue has gained considerable amount of attention. It has 2 major types, central and peripheral, which may occur together or alone. Although fatigue has many strong relations with depression and sleep disorders, it is a separate entity. For the diagnosis of fatigue, self-reports and patient-reported outcomes are highly valuable tools because these methods can reflect patients' perceptions. Treating the underlying disease with newly developed direct-acting antivirals often improves the perceived fatigue. Healthy lifestyle changes are the cornerstone of the treatment. Copyright © 2017 Elsevier Inc. All rights reserved.

  5. Resistance training during pregnancy and perinatal outcomes.

    Science.gov (United States)

    White, Erin; Pivarnik, Jim; Pfeiffer, Karin

    2014-08-01

    Approximately 10% of women engage in resistance training during pregnancy; however there is limited research on this activity. The purpose of this study was to examine associations between resistance training and adverse outcomes. Women completed an online survey and recalled their exercise habits during each trimester of their most recent pregnancy within the previous 5 years. Women also reported pregnancy and birth outcomes. Participants were then categorized into 3 groups based on leisure-time exercise: 1) Resistance + aerobic training (RTAE), 2) Aerobic exercise only (AE), and 3) no exercise (NE). 284 women completed the survey. Women in the RTAE group resistance trained on average 2.9 days/ week for 27.3 minutes/session. The prevalences of hypertensive disorders (HD) and gestational diabetes mellitus (GDM) were significantly lower in the RTAE group when compared with the grouping of AE + NE women. Prepregnancy body mass index (BMI) was the strongest factor related to both GDM and HD. There was no difference in the risk of preterm labor, mode of delivery, or gestational age at delivery by exercise status. Our results suggest that women can safely engage in aerobic exercise and resistance training for muscular endurance 3 days/week for 30 minutes throughout gestation.

  6. Periodontal treatment outcomes during pregnancy and postpartum.

    Science.gov (United States)

    Moreira, Carlos Heitor Cunha; Weidlich, Patrícia; Fiorini, Tiago; da Rocha, José Mariano; Musskopf, Marta Liliana; Susin, Cristiano; Oppermann, Rui Vicente; Rösing, Cassiano Kuchenbecker

    2015-09-01

    This study was conducted to compare periodontal therapy outcomes during pregnancy and after delivery. One hundred nine pregnant women up to the 20th gestational week (GW) were randomized into two groups: the test group (comprehensive periodontal therapy during pregnancy) and the control group (comprehensive periodontal therapy after delivery). Periodontal examinations comprised plaque index (PI), gingival index (GI), periodontal probing depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), and gingival crevicular fluid (GCF) volume. After baseline examination, women in the test group received periodontal treatment up to the 24th GW. The final examination was performed at the 26th to the 28th GW. Women in the control group were treated 30 days after delivery and reexamined 30 days after treatment. Periodontal therapy significantly reduced periodontal inflammation in both groups. The mean percentage of sites with BOP was reduced from 49.14 % (±22.49) to 11.10 % (±7.84) and from 45.71 % (±17.86) to 8.07 % (±5.21) in the test and control groups, respectively (p = 0.95). No statistically significant differences were observed between groups concerning PI, GI, PPD, CAL, and GCF. The reduction in mean percentage of sites with BOP stratified for initial PPD ≥4 mm was higher in the control group (p pregnancy do not interfere in treatment outcomes in women with widespread gingival inflammation and limited periodontal destruction. The role of these hormonal changes in pregnant women with different disease patterns remains uncertain. Periodontal health can be reestablished irrespective of the hormonal challenge that takes place during pregnancy.

  7. 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.

  8. Periodontal treatment for preventing adverse pregnancy outcomes

    DEFF Research Database (Denmark)

    Schwendicke, Falk; Karimbux, Nadeem; Allareddy, Veerasathpurush

    2015-01-01

    OBJECTIVES: Periodontal treatment might reduce adverse pregnancy outcomes. The efficacy of periodontal treatment to prevent preterm birth, low birth weight, and perinatal mortality was evaluated using meta-analysis and trial sequential analysis. METHODS: An existing systematic review was updated...... risk of random errors. RESULTS: Thirteen randomized clinical trials evaluating 6283 pregnant women were meta-analyzed. Four and nine trials had low and high risk of bias, respectively. Overall, periodontal treatment had no significant effect on preterm birth (odds ratio [95% confidence interval] 0.......79 [0.57-1.10]) or low birth weight (0.69 [0.43-1.13]). Trial sequential analysis demonstrated that futility was not reached for any of the outcomes. For populations with moderate occurrence (periodontal treatment was not efficacious for any of the outcomes...

  9. Pregnancy outcomes and surgical management of pregnancy complicated by appendicitis: obstetrician view

    OpenAIRE

    Şimşek, Deniz; Turan, Özgür Deniz; Ergenoğlu, Ahmet Mete; Sezer, Taylan Özgür; Şahin, Çağdaş; Demir, Halit Batuhan

    2015-01-01

    Objective: To evaluate the pregnancy outcomes of patients who underwent appendectomy during pregnancy. Materials and Methods: Patients who underwent appendectomy between years 2010 and 2014 were retrospectively evaluated. All patients’ pregnancy outcomes were followed-up by using university registry system and telephone interview. Patients were evaluated regarding age, gestational age, clinical and laboratory examinations, imaging studies, mean time interval between emergenc...

  10. Pregnancy Outcomes and Surgical Management of Pregnancy Complicated By Appendicitis: Obstetrician View

    OpenAIRE

    Deniz Şimşek; Özgür Deniz Turan; Ahmet Mete Ergenoğlu; Halit Batuhan Demir; Taylan Özgür Sezer; Çağdaş Şahin

    2015-01-01

    Objective: To evaluate the pregnancy outcomes of patients who underwent appendectomy during pregnancy. Materials and Methods: Patients who underwent appendectomy between years 2010 and 2014 were retrospectively evaluated. All patients’ pregnancy outcomes were followed-up by using university registry system and telephone interview. Patients were evaluated regarding age, gestational age, clinical and laboratory examinations, imaging studies, mean time interval between emergency department an...

  11. 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

  12. Patient-Reported Esthetic and Functional Outcomes of Primary Total Laparoscopic Intestinal Vaginoplasty in Transgender Women With Penoscrotal Hypoplasia

    NARCIS (Netherlands)

    Bouman, M.B.; Sluis, W.B. van der; Woudenberg Hamstra, L.E. van; Buncamper, M.E.; Kreukels, B.P.; Meijerink, W.J.H.J.; Mullender, M.G.

    2016-01-01

    INTRODUCTION: Puberty-suppressing hormonal treatment may result in penoscrotal hypoplasia in transgender women, making standard penile inversion vaginoplasty not feasible. For these patients, intestinal vaginoplasty is a surgical alternative, but knowledge on patient-reported postoperative outcomes

  13. Frequency of hepatitis C in pregnancy and pregnancy outcome

    International Nuclear Information System (INIS)

    Jaffery, T.; Tariq, N.; Ayub, R.; Yawar, A.

    2005-01-01

    Objective: To determine the frequency of HCV infections in pregnant women, to find out the risk factors of HCV infection in pregnant women and to compare pregnancy outcome of the sero-positive women with sero-negative women. Design: Case-control study. Place and Duration of Study: Shifa International Hospital, Islamabad, from June 2001 to May 2002. Patients and Methods: Study was conducted on 947 booked pregnant women who were screened for HCV antibodies during antenatal consultation and were admitted for delivery in labor room. At the time of admission in labor ward, medical records of all patients were reviewed for anti HCV antibody testing and the presence of risk factors for HCV infection. Previous vaginal deliveries with episiotomy, previous surgeries, blood transfusions, and D and C for abortion or dysfunctional uterine bleeding were taken as independent variables. The obstetric outcome variables studied were: completed weeks of gestation by mother, birth weight and apgar score of newborns. The risk factors under study and the outcome variables were compared among HCV positive and negative women through a case-control study and measures of association calculated. Results: The proportion of HCV sero-positively among pregnant woman in our study was 3.27%. Among all the risk factors under study, previous surgery was found to have a significant association with HCV positive status of women (p=0.001). Other variables did not have significant association with HCV positive status in our study. There was no statistical difference in the mean birth weight of newborns (p=0.94), mean Apgar score of newborns (p=0.73) and mean gestational period among HCV positive cases and controls (p=0.47). Conclusion: Prevalence of hepatitis C in pregnant women was 3.27%. Past history of surgical procedures was the most important factor for transmission of hepatitis C virus infection. No adverse effect on pregnancy outcome was observed in terms of gestational age, Apgar score and baby

  14. 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

  15. 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

  16. OMERACT Endorsement of Patient-reported Outcome Instruments in Antineutrophil Cytoplasmic Antibody–associated Vasculitis

    Science.gov (United States)

    Robson, Joanna C.; Tomasson, Gunnar; Milman, Nataliya; Ashdown, Sue; Boonen, Annelies; Casey, George C.; Cronholm, Peter F.; Cuthbertson, David; Dawson, Jill; Direskeneli, Haner; Easley, Ebony; Kermani, Tanaz A.; Farrar, John T.; Gebhart, Don; Lanier, Georgia; Luqmani, Raashid A.; Mahr, Alfred; McAlear, Carol A.; Peck, Jacqueline; Shea, Beverley; Shea, Judy A.; Sreih, Antoine G.; Tugwell, Peter S.; Merkel, Peter A.

    2018-01-01

    Objective The antineutrophil cytoplasmic antibody–associated vasculitides (AAV) are multiorgan diseases. Patients with AAV report impairment in their health-related quality of life (HRQOL) and have different priorities regarding disease assessment compared with physicians. The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group previously received endorsement for a core set of domains in AAV. Two approaches to measure patient-reported outcomes (PRO) were presented at OMERACT 2016. Methods A novel 5-step tool was used to facilitate assessment of the instruments by delegates: the OMERACT Filter 2.0 Instrument Selection Algorithm, with a red-amber-green checklist of questions, including (1) good match with domain (face and content validity), (2) feasibility, (3) do numeric scores make sense (construct validity)?, (4) overall ratings of discrimination, and (5) can individual thresholds of meaning be defined? Delegates gave an overall endorsement. Three generic Patient-Reported Outcomes Measurement Information System (PROMIS) instruments (fatigue, physical functioning, and pain interference) and a disease-specific PRO, the AAV-PRO (6 domains related to symptoms and HRQOL), were presented. Results OMERACT delegates endorsed the use of the PROMIS instruments for fatigue, physical functioning, and pain interference (87.6% overall endorsement) and the disease-specific AAV-PRO instrument (89.4% overall endorsement). Conclusion The OMERACT Vasculitis Working Group gained endorsement by OMERACT for use of the PROMIS and the AAV-PRO in clinical trials of vasculitis. These instruments are complementary to each other. The PROMIS and the AAV-PRO need further work to assess their utility in longitudinal settings, including their ability to discriminate between treatments of varying efficacy in the setting of a randomized controlled trial. PMID:28864650

  17. Beyond FEV1 in COPD: a review of patient-reported outcomes and their measurement

    Directory of Open Access Journals (Sweden)

    Jones P

    2012-10-01

    Full Text Available Paul Jones,1 Marc Miravitlles,2 Thys van der Molen,3 Karoly Kulich41Division of Clinical Science, University of London, London, UK; 2Institut d'Investigacions Biomèdiques August Pi i Sunyer, Hospital Clínic, Ciber de Enfermedades Respiratorias, Barcelona, Spain; 3Department of Primary Care, University Medical Centre Groningen, Groningen, The Netherlands; 4Novartis Pharma AG, Basel, SwitzerlandAbstract: Patients with chronic obstructive pulmonary disease (COPD present with a variety of symptoms and pathological consequences. Although primarily viewed as a respiratory disease, COPD has both pulmonary and extrapulmonary effects, which have an impact on many aspects of physical, emotional, and mental well-being. Traditional assessment of COPD relies heavily on measuring lung function, specifically forced expiratory volume in 1 second (FEV1. However, the evidence suggests that FEV1 is a relatively poor correlate of symptoms such as breathlessness and the impact of COPD on daily life. Furthermore, many consequences of the disease, including anxiety and depression and the ability to perform daily activities, can only be described and reported reliably by the patient. Thus, in order to provide a comprehensive view of the effects of interventions in clinical trials, it is essential that spirometry is accompanied by assessments using patient-reported outcome (PRO instruments. We provide an overview of patient-reported outcome concepts in COPD, such as breathlessness, physical functioning, and health status, and evaluate the tools used for measuring these concepts. Particular attention is given to the newly developed instruments emerging in response to recent regulatory guidelines for the development and use of PROs in clinical trials. We conclude that although data from the development and validation of these new PRO instruments are emerging, to build the body of evidence that supports the use of a new instrument takes many years. Furthermore, new

  18. The oral microbiome and adverse pregnancy outcomes

    Directory of Open Access Journals (Sweden)

    Cobb CM

    2017-08-01

    Full Text Available Charles M Cobb,1 Patricia J Kelly,2 Karen B Williams,3 Shilpa Babbar,4 Mubashir Angolkar,5 Richard J Derman6 1Department of Periodontics, School of Dentistry, 2Department of Public Health Nursing, School of Nursing and Health Studies, 3Department of Biomedical & Health Informatics, School of Medicine, University of Missouri-Kansas City, Kansas City, MO, 4Department of Obstetrics, Gynecology & Women’s Health, Division of Maternal & Fetal Medicine, School of Medicine, Saint Louis University, St Louis, MO, USA; 5Department of Public Health, Jawaharlal Nehru Medical College (JNMC, KLE University, Karnataka, India; 6Department of Obstetrics & Gynecology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA Abstract: Significant evidence supports an association between periodontal pathogenic bacteria and preterm birth and preeclampsia. The virulence properties assigned to specific oral pathogenic bacteria, for example, Fusobacterium nucleatum, Porphyromonas gingivalis, Filifactor alocis, Campylobacter rectus, and others, render them as potential collaborators in adverse outcomes of pregnancy. Several pathways have been suggested for this association: 1 hematogenous spread (bacteremia of periodontal pathogens; 2 hematogenous spread of multiple mediators of inflammation that are generated by the host and/or fetal immune response to pathogenic bacteria; and 3 the possibility of oral microbial pathogen transmission, with subsequent colonization, in the vaginal microbiome resulting from sexual practices. As periodontal disease is, for the most part, preventable, the medical and dental public health communities can address intervention strategies to control oral inflammatory disease, lessen the systemic inflammatory burden, and ultimately reduce the potential for adverse pregnancy outcomes. This article reviews the oral, vaginal, and placental microbiomes, considers their potential impact on preterm labor, and the future

  19. Substance abuse during pregnancy: effect on pregnancy outcomes.

    Science.gov (United States)

    Pinto, S M; Dodd, S; Walkinshaw, S A; Siney, C; Kakkar, P; Mousa, H A

    2010-06-01

    To determine the contribution of drug use to maternal and perinatal complications, controlling for social confounders. This is a retrospective cohort study of 247 drug-using women and 741 controls over a 4-year period from 1997 to 2000. Cases were identified from the drug dependency register. Three controls for each woman with substance abuse were selected from the delivery suite records, with calliper matching by year of delivery (any control patient who delivered within 6 months before or after the date of delivery of a drug-using woman was considered as a potential match) and district of residence (post code). The primary outcomes of interest were preterm birth, abruption, pre-eclampsia, intrauterine growth restriction and low birth weight. There were statistically significantly more preterm births amongst drug-using women (relative risk (RR) 2.5, 95% confidence interval (CI) 1.6-3.8), with preterm births complicating 25% of births amongst drug users. The incidence of low birth weight was 30.8% amongst drug-using women compared to 8% in control women (RR 3.6, CI 2.4-5.4), and the incidence of growth restriction was 25%, significantly higher than the control group (RR 3.82, CI 2.4-6.1). The risk of abruption was also higher (RR 2.74, CI 1.1-7.0). Of note is the extremely low incidence of pre-eclampsia among drug users, even after controlling for the confounder effects of parity and smoking. Despite multidisciplinary co-ordinated antenatal care, women with substance abuse during pregnancy are at significant risk of adverse obstetric and perinatal outcome, controlling for social confounders. A limitation of the study is that the sample size was not large enough to clearly assess individual drugs. This is the first study to highlight low incidence of pre-eclampsia among drug users over and above the effect of smoking. Further research is needed to elucidate the underlying biological reason for the lack of pre-eclampsia in women with substance abuse during pregnancy

  20. Life after endometrial cancer: A systematic review of patient-reported outcomes.

    Science.gov (United States)

    Shisler, Robert; Sinnott, Jennifer A; Wang, Vivian; Hebert, Courtney; Salani, Ritu; Felix, Ashley S

    2018-02-01

    Women with endometrial cancer (EC) are the second largest population of female cancer survivors in the United States. However, the outcomes of EC survivors, from the patient perspective, are not well-understood. Therefore, we conducted a systematic review of patient-reported outcomes (PROs) following an EC diagnosis. We searched MEDLINE, EMBASE, Scopus, CINAHL, and reference lists to identify published observational studies that examined PROs among women with EC. Reviewers independently reviewed eligible full-text study articles and conducted data extraction. We qualitatively summarized included articles according to exposures [e.g. body mass index (BMI), treatment, etc.] or specific PROs (e.g. sexual function). Of 1722 unique studies, 102 full-text articles were reviewed, of which a total of 27 studies fulfilled the inclusion criteria. The most commonly used PRO questionnaires were the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) (n=9), Short Form 36 Questionnaire (SF-36, n=8), the Functional Assessment of Cancer Therapy-General (FACT-G, n=5), and the Female Sexual Function Index (FSFI, n=4). Obesity was associated with lower quality of life (QOL) and physical functioning. Treatment type affected several outcomes. Laparoscopy generally resulted in better QOL outcomes than laparotomy. Likewise, vaginal brachytherapy was associated with better outcomes compared to external beam radiation. Sexual function outcomes were dependent on age, time since diagnosis, and having consulted a physician before engaging in sexual activities. In addition, a physical activity intervention was associated with improved sexual interest but not sexual function. Our review provides insight into the experience of EC survivors from the patient perspective. Factors that contribute to QOL, such as pain, fatigue, emotional and social functioning, should be monitored following an EC diagnosis. Copyright © 2017 Elsevier Inc

  1. Adverse pregnancy outcomes following syphilis treatment in pregnancy in the UK.

    Science.gov (United States)

    Wallace, Harriet E; Isitt, Catherine E; Broomhall, Harriet M; Perry, Alison E; Wilson, Janet D

    2016-10-01

    Syphilis infection in pregnancy is known to cause a number of severe adverse pregnancy outcomes, including second-trimester miscarriage, stillbirth, very pre-term delivery and neonatal death, in addition to congenital syphilis. A retrospective review of women with positive syphilis serology and a pregnancy outcome between 2005 and 2012 in Leeds, UK, was performed. In all, 57 cases of positive syphilis serology in pregnancy were identified: 24 with untreated syphilis treated in the current pregnancy (Group 1); seven with reported but unconfirmed prior treatment who were retreated (Group 2); and 26 adequately treated prior to pregnancy (Group 3). The rate of severe adverse pregnancy outcomes in Group 1 at 21% was significantly higher than the 0% outcome of Group 3 (p = 0.02). The severe adverse pregnancy outcomes were two second-trimester miscarriages, two pre-term births at 25 and 28 weeks and one stillbirth at 32 weeks. There were no cases of term congenital syphilis or term neonatal death, but we observed high rates of other adverse pregnancy outcomes despite treatment during pregnancy. Rapid referral for treatment is needed before 18 weeks in order to minimise adverse pregnancy outcomes. © The Author(s) 2016.

  2. 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.

  3. Development of a patient-reported outcome instrument for patients with lumbar radicular pain

    DEFF Research Database (Denmark)

    Ibsen, Charlotte; Schiøttz-Christensen, Berit; Nielsen, Claus Vinther

    Background: Low back pain (LBP) is the leading contributor to years lived with disability. It is a complex biopsychosocial phenomenon where complete differential diagnosis and assessment is difficult and needs to be comprehensive. Therefore a biopsychosocial approach is recommended. Substantial...... pain. Methods: The development of the PRO will be based on ICF Comprehensive Core Set for Low Back Pain and Rehabilitation Set and existing items from the The Patient-Reported Outcomes Measurement Information System (PROMIS®). The development process will be divided into five steps: 1. Linking PROMIS....... Conclusion(s) : A PRO instrument is developed to systematise and qualify the description on functioning among patients with lumbar radicular pain. The development process is in progress and next step is to engage patients and clinicians in the development process.  Implications : With development of this PRO...

  4. Emerging good practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) measures.

    Science.gov (United States)

    Acquadro, Catherine; Patrick, Donald L; Eremenco, Sonya; Martin, Mona L; Kuliś, Dagmara; Correia, Helena; Conway, Katrin

    2017-01-01

    This paper presents emerging Good Practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) Measures. The ISOQOL Translation and Cultural Adaptation Special Interest Group (TCA-SIG) undertook the review of several TA approaches, with the collaboration of organizations who are involved in conducting TA, and members of the TCA-SIG. The effort led to agreement by the writing group on Good Practices for 1) the terminology to be used in referring to translatability process, 2) the best definition of TA, 3) the methodology that is recommended at each step of the process, 4) the persons involved in TA, 5) the timing of assessment, 6) the review criteria for TA, and 7) the recommendations to be made at the end of the TA process. With input from the TCA-SIG membership and in consultation with experts in the field, these emerging good practices can guide the future use of TA in the development of PROs.

  5. Patient reported outcomes in patients undergoing arthroscopic partial meniscectomy for traumatic or degenerative meniscal tears

    DEFF Research Database (Denmark)

    Thorlund, Jonas Bloch; Englund, Martin; Christensen, Robin

    2017-01-01

    OBJECTIVES: To compare patient reported outcomes from before surgery to 52 weeks after surgery between individuals undergoing arthroscopic partial meniscectomy for traumatic meniscal tears and those for degenerative meniscal tears. DESIGN: Comparative prospective cohort study. SETTING: Four public......-55, and undergoing arthroscopic partial meniscectomy for a traumatic or degenerative meniscal tear (defined by a combination of age and symptom onset). INTERVENTIONS: Both participant groups underwent arthroscopic partial meniscectomy for a meniscal tear, with operating surgeons recording relevant information......% women) with a traumatic or degenerative meniscal tear (n=141, mean age 38.7 years (standard deviation 10.9); n=256, 46.6 years (6.4); respectively) were included in the main analysis. At 52 weeks after arthroscopic partial meniscectomy, 55 (14%) patients were lost to follow-up. Statistically...

  6. Patient-reported outcome and risk of revision after shoulder replacement for osteoarthritis

    DEFF Research Database (Denmark)

    Rasmussen, Jeppe V; Polk, Anne; Brorson, Stig

    2014-01-01

    PURPOSE: We used patient-reported outcome and risk of revision to compare hemiarthroplasty (HA) with total shoulder arthroplasty (TSA) and stemmed hemiarthroplasty (SHA) with resurfacing hemiarthroplasty (RHA) in patients with glenohumeral osteoarthritis. PATIENTS AND METHODS: We included all...... of presentation, the raw scores were converted to a percentage of the maximum score. Revision rates were calculated by checking reported revisions to the DSR until December 2011. WOOS and risk of revision were adjusted for age, sex, previous surgery, and type of osteoarthritis. RESULTS: There were 113 TSAs...... and 1096 HAs (837 RHAs and 259 SHAs). Patients treated with TSA generally had a better WOOS, exceeding the predefined minimal clinically important difference, at 1 year (mean difference 10, p

  7. Operation for recurrent cystocele with anterior colporrhaphy or non-absorbable mesh: patient reported outcomes

    DEFF Research Database (Denmark)

    Nüssler, Emil Karl; Greisen, Susanne; Kesmodel, Ulrik Schiøler

    2013-01-01

    Abstract INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare patient reported outcomes and complications after repair of recurrent anterior vaginal wall prolapse in routine health care settings using standard anterior colporrhaphy or non-absorbable mesh. METHODS: The study is based...... on prospective data from the Swedish National Register for Gynaecological Surgery. 286 women were operated on for recurrent anterior vaginal wall prolapse in 2008-2010; 157 women had an anterior colporrhaphy and 129 were operated on with a non-absorbable mesh. Pre-, and perioperative data were collected from...... (0.6 %) in the anterior colporrhaphy group (p = 0.58). The infection rate was higher after mesh (8.5 %) than after anterior colporrhaphy (2.5 %; OR 3.19 ; 1.07-14.25). CONCLUSION: Implantation of synthetic mesh during operation for recurrent cystocele more than doubled the cure rate, whereas...

  8. Utilization of patient-reported outcomes as a step towards collaborative medicine.

    Science.gov (United States)

    Blackwell, Laura S; Marciel, Kristen K; Quittner, Alexandra L

    2013-09-01

    Patient-reported outcomes (PROs) have been successfully developed for a variety of chronic respiratory diseases, such as asthma and cystic fibrosis (CF). They have recently been used to evaluate the efficacy of new medications and assess current patient functioning. Although regulatory bodies have favored PROs that measures symptoms, other domains of functioning, such as treatment burden, should be considered. This review examines current guidelines for the development and application of PROs in clinical trials, describes methods for selecting appropriate measures for paediatric populations, and presents a model incorporating PROs into clinical practice. Guidance on interpretation of these measures and graphic presentation of results are illustrated. PROs can serve as the link between the health care provider and patient to foster collaborative and personalized medicine. This model promotes greater patient responsibility, facilitates communication with providers, encourages shared decision-making, and enhances adherence. Published by Elsevier Ltd.

  9. Intercentre variance in patient reported outcomes is lower than objective rheumatoid arthritis activity measures

    DEFF Research Database (Denmark)

    Khan, Nasim Ahmed; Spencer, Horace Jack; Nikiphorou, Elena

    2017-01-01

    Objective: To assess intercentre variability in the ACR core set measures, DAS28 based on three variables (DAS28v3) and Routine Assessment of Patient Index Data 3 in a multinational study. Methods: Seven thousand and twenty-three patients were recruited (84 centres; 30 countries) using a standard...... built to adjust for the remaining ACR core set measure (for each ACR core set measure or each composite index), socio-demographics and medical characteristics. ANOVA and analysis of covariance models yielded similar results, and ANOVA tables were used to present variance attributable to recruiting...... centre. Results: The proportion of variances attributable to recruiting centre was lower for patient reported outcomes (PROs: pain, HAQ, patient global) compared with objective measures (joint counts, ESR, physician global) in all models. In the full model, variance in PROs attributable to recruiting...

  10. Case-mix & patients' reports of outcome in Independent Sector Treatment Centres: Comparison with NHS providers

    Directory of Open Access Journals (Sweden)

    van der Meulen Jan

    2008-04-01

    Full Text Available Abstract Background There has been considerable concern expressed about the outcomes achieved in Independent Sector Treatment Centres (ISTCs introduced in England since 2003. Our aim was to compare the case-mix and patients' reported outcomes of surgery in ISTCs and in NHS providers. Methods Prospective cohort study of 769 patients treated in six ISTCs and 1895 treated in 20 NHS providers (acute hospitals and treatment centres in England during 2006–07. Participants underwent one of three day surgery procedures (inguinal hernia repair, varicose vein surgery, cataract extraction or hip or knee replacement. Change in patient-reported health status and health related quality of life (measured using a disease-specific and a generic (EQ-5D instrument was assessed either 3-months (day surgery or 6-months (hip/knee after surgery. In addition patient-reported post-operative complications and an overall assessment of success of surgery were collected. Outcome measures were adjusted (using multivariable regression for patient characteristics (disease severity, duration of symptoms, age, sex, socioeconomic status, general health, previous similar surgery, comorbidity. Results Post-operative response rates varied by procedure (73%–88% and were similar for those treated in ISTCs and NHS facilities. Patients treated in ISTCs were healthier, were less likely to have any comorbidity and, for those undergoing cataract surgery or joint replacement, their primary condition was less severe. Those undergoing hernia repair or joint replacement were less likely to have had similar surgery before. When adjustment was made for pre-operative characteristics, patients undergoing cataract surgery or hip replacement in ISTCs achieved a slightly greater improvement in functional status and quality of life than those treated in NHS facilities, while the opposite was true of patients undergoing hernia repair. No significant differences were found for the two other

  11. Patient-reported outcomes in insomnia: development of a conceptual framework and endpoint model.

    Science.gov (United States)

    Kleinman, Leah; Buysse, Daniel J; Harding, Gale; Lichstein, Kenneth; Kalsekar, Anupama; Roth, Thomas

    2013-01-01

    This article describes qualitative research conducted with patients with clinical diagnoses of insomnia and focuses on the development of a conceptual framework and endpoint model that identifies a hierarchy and interrelationships of potential outcomes in insomnia research. Focus groups were convened to discuss how patients experience insomnia and to generate items for patient-reported questionnaires on insomnia and associated daytime consequences. Results for the focus group produced two conceptual frameworks: one for sleep and one for daytime impairment. Each conceptual framework consists of hypothesized domains and items in each domain based on patient language taken from the focus group. These item pools may ultimately serve as a basis to develop new questionnaires to assess insomnia.

  12. Patient-Reported Outcome and Quality of Life Instruments Database (PROQOLID: Frequently asked questions

    Directory of Open Access Journals (Sweden)

    Perrier Laure-Lou

    2005-03-01

    Full Text Available Abstract The exponential development of Patient-Reported Outcomes (PRO measures in clinical research has led to the creation of the Patient-Reported Outcome and Quality of Life Instruments Database (PROQOLID to facilitate the selection process of PRO measures in clinical research. The project was initiated by Mapi Research Trust in Lyon, France. Initially called QOLID (Quality of Life Instruments Database, the project's purpose was to provide all those involved in health care evaluation with a comprehensive and unique source of information on PRO and HRQOL measures available through the Internet. PROQOLID currently describes more than 470 PRO instruments in a structured format. It is available in two levels, non-subscribers and subscribers, at http://www.proqolid.org. The first level is free of charge and contains 14 categories of basic useful information on the instruments (e.g. author, objective, original language, list of existing translations, etc.. The second level provides significantly more information about the instruments. It includes review copies of over 350 original instruments, 120 user manuals and 350 translations. Most are available in PDF format. This level is only accessible to annual subscribers. PROQOLID is updated in close collaboration with the instruments' authors on a regular basis. Fifty or more new instruments are added to the database annually. Today, all of the major pharmaceutical companies, prestigious institutions (such as the FDA, the NIH's National Cancer Institute, the U.S. Veterans Administration, dozens of universities, public institutions and researchers subscribe to PROQOLID on a yearly basis. More than 800 users per day routinely visit the database.

  13. Mining telemonitored physiological data and patient-reported outcomes of congestive heart failure patients.

    Science.gov (United States)

    Mlakar, Miha; Puddu, Paolo Emilio; Somrak, Maja; Bonfiglio, Silvio; Luštrek, Mitja

    2018-01-01

    This paper addresses patient-reported outcomes (PROs) and telemonitoring in congestive heart failure (CHF), both increasingly important topics. The interest in CHF trials is shifting from hard end-points such as hospitalization and mortality, to softer end-points such health-related quality of life. However, the relation of these softer end-points to objective parameters is not well studied. Telemonitoring is suitable for collecting both patient-reported outcomes and objective parameters. Most telemonitoring studies, however, do not take full advantage of the available sensor technology and intelligent data analysis. The Chiron clinical observational study was performed among 24 CHF patients (17 men and 7 women, age 62.9 ± 9.4 years, 15 NYHA class II and 9 class III, 10 of ishaemic, aetiology, 6 dilated, 2 valvular, and 6 of multiple aetiologies or cardiomyopathy) in Italy and UK. A large number of physiological and ambient parameters were collected by wearable and other devices, together with PROs describing how well the patients felt, over 1,086 days of observation. The resulting data were mined for relations between the objective parameters and the PROs. The objective parameters (humidity, ambient temperature, blood pressure, SpO2, and sweeting intensity) could predict the PROs with accuracies up to 86% and AUC up to 0.83, making this the first report providing evidence for ambient and physiological parameters to be objectively related to PROs in CHF patients. We also analyzed the relations in the predictive models, gaining some insights into what affects the feeling of health, which was also generally not attempted in previous investigations. The paper strongly points to the possibility of using PROs as primary end-points in future trials.

  14. 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

  15. Study protocol: patient reported outcomes for bladder management strategies in spinal cord injury.

    Science.gov (United States)

    Patel, Darshan P; Lenherr, Sara M; Stoffel, John T; Elliott, Sean P; Welk, Blayne; Presson, Angela P; Jha, Amitabh; Rosenbluth, Jeffrey; Myers, Jeremy B

    2017-10-10

    The majority of spinal cord injury (SCI) patients have urinary issues, such as incontinence, retention, and frequency. These problems place a significant burden on patients' physical health and quality of life (QoL). There are a wide variety of bladder management strategies available to patients with no clear guidelines on appropriate selection. Inappropriate bladder management can cause hospitalizations and serious complications, such as urosepsis and renal failure. Patients believe that both independence and ability to carry out daily activities are just as important as physical health in selecting the right bladder-management strategy but little is known about patient's QoL with different bladder managements. Our study's aim is to assess patient reported QoL measures with various bladder managements after SCI. This manuscript describes the approach, study design and common data elements for our central study. This is a multi-institutional prospective cohort study comparing three different bladder-management strategies (clean intermittent catheterization, indwelling catheters, and surgery). Information collected from participants includes demographics, past medical and surgical history, injury characteristics, current and past bladder management, and SCI /bladder-related complications. Patient reported outcomes and QoL questionnaires were administered at enrollment and every 3 months for 1 year. Aims of this study protocol are: (1) to assess baseline QoL differences between the three different bladder-management strategies; (2) determine QoL impact when those using either form of catheter management undergo a surgery over the 1 year of follow-up among patients eligible for surgery; (3) assess the effects of changes in bladder management and complications on QoL over a 1-year longitudinal follow-up. By providing information about patient-reported outcomes associated with different bladder management strategies after SCI, and the impact of bladder management

  16. Financial Hardship and Patient-Reported Outcomes after Hematopoietic Cell Transplantation

    Science.gov (United States)

    Abel, Gregory A.; Albelda, Randy; Khera, Nandita; Hahn, Theresa; Salas Coronado, Diana Y.; Odejide, Oreofe O.; Bona, Kira; Tucker-Seeley, Reginald; Soiffer, Robert

    2016-01-01

    Although hematopoietic cell transplantation (HCT) is the only curative therapy for many advanced hematologic cancers, little is known about the financial hardship experienced by HCT patients, nor the association of hardship with patient-reported outcomes. We mailed a 43-item survey to adult patients approximately 180 days post first autologous or allogeneic HCT at three high-volume centers. We assessed decreases in household income, difficulty with HCT-related costs such as need to relocate or travel, and two types of hardship: “hardship_1” (reporting one or two of the following: dissatisfaction with present finances, difficulty meeting monthly bill payments, or not having enough money at the end of the month), and “hardship_2” (reporting all three). Patient-reported stress was measured with the Perceived Stress Scale (PSS-4), and seven-point scales were provided for perceptions of overall quality of life (QOL) and health. 325 of 499 surveys (65.1%) were received. The median days since HCT was 173; 47% underwent an allogeneic HCT, 60% were male, 51% were > 60 years old, and 92% were white. Overall, 46% reported income decline post-HCT, 56% reported “hardship_1” and 15% “hardship 2.” In multivariable models controlling for income, those reporting difficulty paying for HCT-related costs were more likely to report financial hardship (OR 6.9 [3.8, 12.3]). “Hardship_1” was associated with QOL below the median (OR 2.9 [1.7, 4.9]), health status below the median (OR 2.2 [1.3, 3.6]), and stress above the median (OR 2.1 [1.3, 3.5]). In this sizable cohort of HCT patients, financial hardship was prevalent, and associated with worse QOL and higher levels of perceived stress. Interventions to address patient financial hardship—especially those that ameliorate HCT-specific costs—are likely to improve patient-reported outcomes. PMID:27184627

  17. Financial Hardship and Patient-Reported Outcomes after Hematopoietic Cell Transplantation.

    Science.gov (United States)

    Abel, Gregory A; Albelda, Randy; Khera, Nandita; Hahn, Theresa; Salas Coronado, Diana Y; Odejide, Oreofe O; Bona, Kira; Tucker-Seeley, Reginald; Soiffer, Robert

    2016-08-01

    Although hematopoietic cell transplantation (HCT) is the only curative therapy for many advanced hematologic cancers, little is known about the financial hardship experienced by HCT patients nor the association of hardship with patient-reported outcomes. We mailed a 43-item survey to adult patients approximately 180 days after their first autologous or allogeneic HCT at 3 high-volume centers. We assessed decreases in household income; difficulty with HCT-related costs, such as need to relocate or travel; and 2 types of hardship: hardship_1 (reporting 1 or 2 of the following: dissatisfaction with present finances, difficulty meeting monthly bill payments, or not having enough money at the end of the month) and "hardship_2" (reporting all 3). Patient-reported stress was measured with the Perceived Stress Scale-4, and 7-point scales were provided for perceptions of overall quality of life (QOL) and health. In total, 325 of 499 surveys (65.1%) were received. The median days since HCT was 173; 47% underwent an allogeneic HCT, 60% were male, 51% were > 60 years old, and 92% were white. Overall, 46% reported income decline after HCT, 56% reported hardship_1, and 15% reported hardship_2. In multivariable models controlling for income, those reporting difficulty paying for HCT-related costs were more likely to report financial hardship (odds ratio, 6.9; 95% confidence interval, 3.8 to 12.3). Hardship_1 was associated with QOL below the median (odds ratio, 2.9; 95% confidence interval, 1.7 to 4.9), health status below the median (odds ratio, 2.2; 95% confidence interval, 1.3 to 3.6), and stress above the median (odds ratio, 2.1; 95% confidence interval, 1.3 to 3.5). In this sizable cohort of HCT patients, financial hardship was prevalent and associated with worse QOL and higher levels of perceived stress. Interventions to address patient financial hardship-especially those that ameliorate HCT-specific costs-are likely to improve patient-reported outcomes. Copyright © 2016

  18. 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.

  19. Pregnancy outcome and complications in women with spina bifida.

    Science.gov (United States)

    Arata, M; Grover, S; Dunne, K; Bryan, D

    2000-09-01

    To describe the antenatal complications, mode of delivery and outcome of pregnancy in women with spina bifida. Case series of women known to have attended the spina bifida clinic at the Royal Children's Hospital. Medical records, postal questionnaire and telephone interview were utilized to collect data on the effect of pregnancy on the health of women and the effect of spina bifida on pregnancy outcome. Of 207 women born between 1945 and 1975, 23 reported having a pregnancy, and 17 who had completed pregnancies agreed to participate. The 17 women had a total of 29 pregnancies, with 23 pregnancies progressing to births. Fourteen of 17 women had antenatal admissions, with wheelchair-dependent women requiring more-frequent and longer admissions. Recurrent urinary infections in pregnancy occurred in women with a prior history of urinary infections; stomal problems occurred but were not serious; mobility was reduced for two women during pregnancy, with full recovery afterwards; and preexisting pressure sores worsened during pregnancy. Vaginal deliveries occurred in one in five pregnancies of women who were wheelchair dependent and in ten of eighteen pregnancies in independently mobile women, including seven of eight pregnancies of independently mobile women without ileal conduits. Cesarean sections were accompanied by postoperative complications in 10 women. Women with spina bifida who become pregnant generally have a positive outcome, with relatively low complication rates.

  20. Obstetric outcome of teenage pregnancies at a tertiary hospital in ...

    African Journals Online (AJOL)

    Context: Maternal age, parity, and socioeconomic class are important determinants of obstetric outcome of pregnancy. Teenage pregnancy constitutes a high risk pregnancy with complications arising from a combination of physiological, anatomical, and socioeconomic factors. Objective: The objective was to determine the ...

  1. Outcome of Pregnancy in Patients with Systemic Lupus Erythematosus

    Directory of Open Access Journals (Sweden)

    Chiong-Hee Wong

    2006-06-01

    Conclusion: Pregnancy is relatively safe in women with SLE in remission but should be considered as a high-risk pregnancy. APS is associated with poor pregnancy outcome. The patient needs to cooperate with obstetricians and physicians for optimal disease control and detailed monitoring throughout the gestation.

  2. Teenage Pregnancy and Perinatal Outcomes: Experience from ...

    African Journals Online (AJOL)

    Context: Teenage pregnancy is known as a risk factor for preterm birth, low birth weight and perinatal deaths, thus considered public health problem. In South Africa, most teenage pregnancy is found within the context of unstable relationship and unplanned or unwanted pregnancies. A high rate of teenage pregnancy is ...

  3. Patient-Reported Outcomes and Total Health Care Expenditure in Prediction of Patient Satisfaction: Results From a National Study

    Science.gov (United States)

    Zhang, Weiping; Chen, Wei; Bounsanga, Jerry; Cheng, Christine; Franklin, Jeremy D; Crum, Anthony B; Voss, Maren W; Hon, Shirley D

    2015-01-01

    Background Health care quality is often linked to patient satisfaction. Yet, there is a lack of national studies examining the relationship between patient satisfaction, patient-reported outcomes, and medical expenditure. Objective The aim of this study is to examine the contribution of physical health, mental health, general health, and total health care expenditures to patient satisfaction using a longitudinal, nationally representative sample. Methods Using data from the 2010-2011 Medical Expenditure Panel Survey, analyses were conducted to predict patient satisfaction from patient-reported outcomes and total health care expenditures. The study sample consisted of adult participants (N=10,157), with sampling weights representative of 233.26 million people in the United States. Results The results indicated that patient-reported outcomes and total health care expenditure were associated with patient satisfaction such that higher physical and mental function, higher general health status, and higher total health care expenditure were associated with higher patient satisfaction. Conclusions We found that patient-reported outcomes and total health care expenditure had a significant relationship with patient satisfaction. As more emphasis is placed on health care value and quality, this area of research will become increasingly needed and critical questions should be asked about what we value in health care and whether we can find a balance between patient satisfaction, outcomes, and expenditures. Future research should apply big data analytics to investigate whether there is a differential effect of patient-reported outcomes and medical expenditures on patient satisfaction across different medical specialties. PMID:27227131

  4. Patient-Reported Outcomes and Total Health Care Expenditure in Prediction of Patient Satisfaction: Results From a National Study.

    Science.gov (United States)

    Hung, Man; Zhang, Weiping; Chen, Wei; Bounsanga, Jerry; Cheng, Christine; Franklin, Jeremy D; Crum, Anthony B; Voss, Maren W; Hon, Shirley D

    2015-01-01

    Health care quality is often linked to patient satisfaction. Yet, there is a lack of national studies examining the relationship between patient satisfaction, patient-reported outcomes, and medical expenditure. The aim of this study is to examine the contribution of physical health, mental health, general health, and total health care expenditures to patient satisfaction using a longitudinal, nationally representative sample. Using data from the 2010-2011 Medical Expenditure Panel Survey, analyses were conducted to predict patient satisfaction from patient-reported outcomes and total health care expenditures. The study sample consisted of adult participants (N=10,157), with sampling weights representative of 233.26 million people in the United States. The results indicated that patient-reported outcomes and total health care expenditure were associated with patient satisfaction such that higher physical and mental function, higher general health status, and higher total health care expenditure were associated with higher patient satisfaction. We found that patient-reported outcomes and total health care expenditure had a significant relationship with patient satisfaction. As more emphasis is placed on health care value and quality, this area of research will become increasingly needed and critical questions should be asked about what we value in health care and whether we can find a balance between patient satisfaction, outcomes, and expenditures. Future research should apply big data analytics to investigate whether there is a differential effect of patient-reported outcomes and medical expenditures on patient satisfaction across different medical specialties.

  5. Pregnancy outcome in patients with pityriasis rosea.

    Science.gov (United States)

    Drago, Francesco; Broccolo, Francesco; Zaccaria, Elisa; Malnati, Mauro; Cocuzza, Clementina; Lusso, Paolo; Rebora, Alfredo

    2008-05-01

    The effect of pityriasis rosea (PR) on the outcome of pregnancy has not been previously reported. We sought to investigate the possible impact of PR in pregnant women. In all, 38 women who developed PR during pregnancy were observed. In one of them, who developed PR at 10 weeks' gestation and aborted 2 weeks later, plasma, peripheral blood mononuclear cells, maternal skin, and placental and embryonic tissues were studied by quantitative calibrated real-time polymerase chain reaction for human herpesviruses (HHV)-6 and -7. Controls included plasma from 36 healthy blood donors, plasma and paraffin-embedded tissue sections from 12 patients with other dermatitides, and from placental and embryonic tissues from one woman who presented with a 19-week intrauterine fetal death. Of the 38 women, 9 had a premature delivery and 5 miscarried. In particular, 62% of the women who developed PR within 15 weeks' gestation aborted. Neonatal hypotonia, weak motility, and hyporeactivity were noted in 6 cases. In the patient studied in detail, HHV-6 DNA was detected in plasma, peripheral blood mononuclear cells, skin, and placenta and embryonic tissues, whereas HHV-7 DNA was absent. HHV-6 p41 antigen was detected by immunohistochemistry in skin lesions, placenta, and embryonic tissues. No herpesvirus DNA was detected in plasma and tissues from control subjects. This is a case series study with a small number of patients. PR may be associated with an active HHV-6 infection. In pregnancy, PR may foreshadow premature delivery with neonatal hypotonia and even fetal demise especially if it develops within 15 weeks' gestation.

  6. Risk of Adverse Pregnancy Outcomes at Advanced Maternal Age

    DEFF Research Database (Denmark)

    Frederiksen, Line Elmerdahl; Ernst, Andreas; Brix, Nis

    2018-01-01

    prediction chart showed that advanced maternal age, use of assisted reproductive technology, nulliparous pregnancy, smoking during pregnancy, and obesity increased the absolute predictive risk of an adverse pregnancy outcome. CONCLUSION: Women older than 40 years have a higher risk of chromosomal......OBJECTIVE: To study the possible associations between advanced maternal age and risk of selected adverse pregnancy outcomes. METHODS: The study used a nationwide cohort of 369,516 singleton pregnancies in Denmark followed from 11-14 weeks of gestation to delivery or termination of pregnancy....... Pregnant women aged 35 years or older were divided into two advanced maternal age groups, 35-39 years and 40 years or older, and compared with pregnant women aged 20-34 years. Adverse pregnancy outcomes were chromosomal abnormalities, congenital malformations, miscarriage, stillbirth, and birth before 34...

  7. All together now: findings from a PCORI workshop to align patient-reported outcomes in the electronic health record.

    Science.gov (United States)

    Jensen, Roxanne E; Snyder, Claire F; Basch, Ethan; Frank, Lori; Wu, Albert W

    2016-11-01

    In recent years, patient-reported outcomes have become increasingly collected and integrated into electronic health records. However, there are few cross-cutting recommendations and limited guidance available in this rapidly developing research area. Our goal is to report key findings from a 2013 Patient-Centered Outcomes Research Institute workshop on this topic and a summary of actions that followed from the workshop, and present resulting recommendations that address patient, clinical and research/quality improvement barriers to regular use. These findings provide actionable guidance across research and practice settings to promote and sustain widespread adoption of patient-reported outcomes across patient populations, healthcare settings and electronic health record systems.

  8. Maternal Periodontitis, Preeclampsia and Adverse Pregnancy Outcomes

    Directory of Open Access Journals (Sweden)

    Pourandokht Afshari

    2013-07-01

    Full Text Available Background and Aim: Preeclampsia is a considerable problem of pregnancy. Endothelial dysfunction and placental hypoxia are the current hypothesis of preeclampsia. Chronic inflammation, including periodontitis may provoke systemic maternal and placental pro-inflammatory endothelial dysfunction, which represent a significant risk factor for diseases of vascular origin. So this study was carried out to evaluate the possible relationship between periodontitis and preeclampsia. Methods: A total of 360 pregnant women were included, corresponding to 180 pregnant women with mild or sever periodotitis in one group and 180 pregnant women with periodontal health in the other group. Periodontitis was determined by the sum of all pockets with pocket probing depth (PPD ≥4mm and bleeding on probing. periodontal health was defined as the absence of PPD≥ 4mm. Then two groups evaluated to determine the presence of preeclampsia. After delivery, Child weight at birth and gestational age was also evaluated. Chi square and t test analysis were used to analyze the data. Results: There was statistically significant difference between two groups in presence of preeclampsia (p=0.003. Women who had a worse periodontal condition were at higher risk for preeclampsia. In addition, birth weight and gestational age was statistically lower in the case group than the control group (p < 0.001. Conclusion: The results indicate that the presence and severity of peridontitis increase the risk for occurrence of preeclampsia and adverse pregnancy outcomes.

  9. The association between HIV (treatment), pregnancy serum lipid concentrations and pregnancy outcomes : a systematic review

    NARCIS (Netherlands)

    Harmsen, Marissa J; Browne, Joyce L; Venter, Francois; Klipstein-Grobusch, Kerstin; Rijken, Marcus J

    2017-01-01

    BACKGROUND: Observed adverse effects of antiretroviral therapy (ART) on the lipid profile could be of significance in pregnancy. This systematic review aims to summarize studies that investigated the association between HIV, ART and serum lipids during pregnancy and adverse pregnancy outcomes.

  10. Association of Velopharyngeal Insufficiency With Quality of Life and Patient-Reported Outcomes After Speech Surgery.

    Science.gov (United States)

    Bhuskute, Aditi; Skirko, Jonathan R; Roth, Christina; Bayoumi, Ahmed; Durbin-Johnson, Blythe; Tollefson, Travis T

    2017-09-01

    Patients with cleft palate and other causes of velopharyngeal insufficiency (VPI) suffer adverse effects on social interactions and communication. Measurement of these patient-reported outcomes is needed to help guide surgical and nonsurgical care. To further validate the VPI Effects on Life Outcomes (VELO) instrument, measure the change in quality of life (QOL) after speech surgery, and test the association of change in speech with change in QOL. Prospective descriptive cohort including children and young adults undergoing speech surgery for VPI in a tertiary academic center. Participants completed the validated VELO instrument before and after surgical treatment. The main outcome measures were preoperative and postoperative VELO scores and the perceptual speech assessment of speech intelligibility. The VELO scores are divided into subscale domains. Changes in VELO after surgery were analyzed using linear regression models. VELO scores were analyzed as a function of speech intelligibility adjusting for age and cleft type. The correlation between speech intelligibility rating and VELO scores was estimated using the polyserial correlation. Twenty-nine patients (13 males and 16 females) were included. Mean (SD) age was 7.9 (4.1) years (range, 4-20 years). Pharyngeal flap was used in 14 (48%) cases, Furlow palatoplasty in 12 (41%), and sphincter pharyngoplasty in 1 (3%). The mean (SD) preoperative speech intelligibility rating was 1.71 (1.08), which decreased postoperatively to 0.79 (0.93) in 24 patients who completed protocol (P Speech Intelligibility was correlated with preoperative and postoperative total VELO score (P speech intelligibility. Speech surgery improves VPI-specific quality of life. We confirmed validation in a population of untreated patients with VPI and included pharyngeal flap surgery, which had not previously been included in validation studies. The VELO instrument provides patient-specific outcomes, which allows a broader understanding of the

  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 outcomes in European spondyloarthritis patients: a systematic review of the literature

    Directory of Open Access Journals (Sweden)

    Torre-Alonso JC

    2018-05-01

    Full Text Available Juan Carlos Torre-Alonso,1 Rubén Queiro,2 Marta Comellas,3 Luís Lizán,3,4 Carles Blanch5 1Rheumatology Department, Faculty of Medicine and Health Sciences, University of Oviedo, Hospital Monte Naranco, Oviedo, Spain; 2Rheumatology Division, Hospital Universitario Central de Asturias (HUCA, Oviedo, Spain; 3Outcomes 10, Castellón de la Plana, Spain; 4Medicine Department, Jaime I University, Castellón de la Plana, Spain; 5Health Economics & Market Access, Novartis Pharmaceuticals, Barcelona, Spain Objective: This review aims to summarize the current literature on patient-reported outcomes (PROs in spondyloarthritis (SpA. Patients and methods: We performed a systematic literature review to identify studies (original articles and narrative and systematic reviews regarding PROs (health-related quality of life [HRQoL], satisfaction, preferences, adherence/compliance, and persistence in SpA patients published in the European Union through December 2016. International databases (Medline/PubMed, Cochrane Library, ISI Web of Knowledge, Scopus were searched using keywords in English. The methodological quality of the studies was assessed using the Oxford Centre for Evidence-Based Medicine criteria. Results: A total of 26 publications met the inclusion criteria. Generally, studies indicated that SpA has a negative impact on patients’ HRQoL. In patients with ankylosing spondylitis, physical domains were more affected than emotional ones, whereas for psoriatic arthritis, both physical and psychological factors were strongly affected by the disease. Data indicated that biological agents (BAs greatly contributed to improvement in HRQoL in both ankylosing spondylitis and psoriatic arthritis patients. Findings on compliance with BAs were heterogeneous. However, persistence rates exceeded 50% irrespective of the BA administered. Results on preferences indicated that most SpA patients prefer being involved in decisions regarding their treatment and that

  13. Patient-reported outcome 2 years after lung transplantation: does the underlying diagnosis matter?

    Directory of Open Access Journals (Sweden)

    Ghosh S

    2012-11-01

    Full Text Available Maria Jose Santana,1 David Feeny,2 Sunita Ghosh,3 Dale C Lien41Faculty of Medicine, University of Calgary, Calgary, Alberta, Canada; 2Kaiser Permanente Center for Health Research, Portland, OR, USA; 3Cross Cancer Center, University of Alberta, Edmonton, Alberta, Canada; 4University of Alberta Hospital, Edmonton, Alberta, CanadaPurpose: Transplantation has the potential to produce profound effects on survival and health-related quality of life (HRQL. The inclusion of the patient’s perspective may play an important role in the assessment of the effectiveness of lung transplantation. Patient perspectives are assessed by patient-reported outcome measures, including HRQL measures. We describe how patients’ HRQL among different diagnosis groups can be used by clinicians to monitor and evaluate the outcomes associated with transplantation.Methods: Consecutive lung transplant recipients attending the lung transplant outpatient clinic in a tertiary institution completed the 15-item Health Utilities Index (HUI questionnaire on a touchscreen computer. The results were available to clinicians at every patient visit. The HUI3 covers a range of severity and comorbidities in eight dimensions of health status. Overall HUI3 scores are on a scale in which dead = 0.00 and perfect health = 1.00; disability categories range from no disability = 1 to severe disability <0.70. Single-attribute and overall HUI3 scores were used to compare patients’ HRQL among different diagnosis groups. Random-effect models with time since transplant as a random variable and age, gender, underlying diagnoses, infections, and broncholitis obliterans syndrome as fixed variables were built to identify determinants of health status at 2-years posttransplantation.Results: Two hundred and fourteen lung transplant recipients of whom 61% were male with a mean age of 52 (19–75 years were included in the study. Chronic obstructive pulmonary disease and cystic fibrosis patients displayed

  14. Quality of life and urolithiasis: the patient - reported outcomes measurement information system (PROMIS

    Directory of Open Access Journals (Sweden)

    Nishant Patel

    Full Text Available ABSTRACT Background: With a high rate of recurrence, urolithiasis is a chronic disease that impacts quality of life. The Patient Reported Outcomes Measurement Information System is an NIH validated questionnaire to assess patient quality of life. We evaluated the impact of urolithiasis on quality of life using the NIH-sponsored PROMIS-43 questionnaire. Materials and Methods: Patients reporting to the kidney stone clinic were interviewed to collect information on stone history and demographic information and were asked to complete the PROMIS-43 questionnaire. Quality of life scores were analyzed using gender and age matched groups for the general US population. Statistical comparisons were made based on demographic information and patient stone history. Statistical significance was P<0.05. Results: 103 patients completed the survey. 36% of respondents were male, the average age of the group was 52 years old, with 58% primary income earners, and 35% primary caregivers. 7% had never passed a stone or had a procedure while 17% passed 10 or more stones in their lifetime. Overall, pain and physical function were worse in patients with urolithiasis. Primary income earners had better quality of life while primary caregivers and those with other chronic medical conditions were worse. Patients on dietary and medical therapy had better quality of life scores. Conclusions: Urolithiasis patients subjectively have worse pain and physical function than the general population. The impact of pain on quality of life was greatest in those patients who had more stone episodes, underscoring the importance of preventive measures. Stone prevention measures improve quality of life.

  15. 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

  16. Systematic collection of patient reported outcome research data: A checklist for clinical research professionals.

    Science.gov (United States)

    Wehrlen, Leslie; Krumlauf, Mike; Ness, Elizabeth; Maloof, Damiana; Bevans, Margaret

    2016-05-01

    Understanding the human experience is no longer an outcome explored strictly by social and behavioral researchers. Increasingly, biomedical researchers are also including patient reported outcomes (PROs) in their clinical research studies not only due to calls for increased patient engagement in research but also healthcare. Collecting PROs in clinical research studies offers a lens into the patient's unique perspective providing important information to industry sponsors and the FDA. Approximately 30% of trials include PROs as primary or secondary endpoints and a quarter of FDA new drug, device and biologic applications include PRO data to support labeling claims. In this paper PRO, represents any information obtained directly from the patient or their proxy, without interpretation by another individual to ascertain their health, evaluate symptoms or conditions and extends the reference of PRO, as defined by the FDA, to include other sources such as patient diaries. Consumers and clinicians consistently report that PRO data are valued, and can aide when deciding between treatment options; therefore an integral part of clinical research. However, little guidance exists for clinical research professionals (CRPs) responsible for collecting PRO data on the best practices to ensure quality data collection so that an accurate assessment of the patient's view is collected. Therefore the purpose of this work was to develop and validate a checklist to guide quality collection of PRO data. The checklist synthesizes best practices from published literature and expert opinions addressing practical and methodological challenges CRPs often encounter when collecting PRO data in research settings. Published by Elsevier Inc.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  1. Major malformation risk, pregnancy outcomes, and neurodevelopmental outcomes associated with metformin use during pregnancy.

    Science.gov (United States)

    Andrade, Chittaranjan

    2016-04-01

    There are several reasons why metformin treatment may be considered for women in neuropsychiatric practice. These include prevention or attenuation of antipsychotic-associated weight gain, prevention or treatment of gestational diabetes mellitus (GDM), treatment of type 2 diabetes mellitus, and improvement of conception chances and pregnancy outcomes in the presence of polycystic ovarian disease (PCOD). This article examines the benefits and risks associated with metformin use during pregnancy. The available data suggest that metformin exposure during the first trimester is not associated with major congenital malformations; that metformin reduces the risk of early pregnancy loss, preeclampsia, preterm delivery, and GDM in women with PCOD; that metformin is associated with at least comparable benefits relative to insulin treatment in women with mild GDM; and that neurodevelopmental outcomes at age 1.5-2.5 years are comparable after gestational exposure to metformin and insulin. Whereas study designs were not always ideal and sample sizes were mostly small to modest, the study findings are more encouraging than discouraging and can guide shared decision-making in women who are receiving or may need metformin during pregnancy. © Copyright 2016 Physicians Postgraduate Press, Inc.

  2. Payer Perspectives on Patient-Reported Outcomes in Health Care Decision Making: Oncology Examples.

    Science.gov (United States)

    Brogan, Andrew P; DeMuro, Carla; Barrett, Amy M; D'Alessio, Denise; Bal, Vasudha; Hogue, Susan L

    2017-02-01

    Health authorities and payers increasingly recognize the importance of patient perspectives and patient-reported outcomes (PROs) in health care decision making. However, given the broad variety of PRO endpoints included in clinical programs and variations in the timing of PRO data collection and country-specific needs, the role of PRO data in reimbursement decisions requires characterization. To (a) determine the effect of PRO data on market access and reimbursement decisions for oncology products in multiple markets and (b) assess the effect of PRO data collected after clinical progression on payer decision making. A 3-part assessment (targeted literature review, qualitative one-on-one interviews, and online survey) was undertaken. Published literature was identified through searches in PubMed/MEDLINE and Embase. In addition, a targeted search was conducted of health technology assessment (HTA) agency websites in the United States, the United Kingdom, France, and Germany. Qualitative one-on-one interviews were conducted with 16 payers from the RTI Health Solutions global advisory panel in 14 markets (Australia, Brazil, France, Germany, Italy, South Korea, Netherlands, Poland, Spain, Sweden, Taiwan, Turkey, the United Kingdom, and the United States [n = 3]). Of the 200 payers and payer advisors from the global advisory panel invited to participate in the online survey, 20 respondents (China, France, Germany, Spain [n = 2], Taiwan, the United Kingdom, and the United States [n = 13]) completed the survey, and 6 respondents (Australia, South Korea, and the United States [n = 4]) partially completed the survey. Reviews of the literature and publicly available HTAs and reimbursement decisions suggested that HTA bodies and payers have varying experience with and confidence in PRO data. Payers participating in the survey indicated that PRO data may be especially influential in oncology compared with other therapeutic areas. Payers surveyed offered little differentiation

  3. Association between periodontal disease and pregnancy outcomes.

    Science.gov (United States)

    Soroye, M; Ayanbadejo, P; Savage, K; Oluwole, A

    2015-12-01

    To evaluate the association between periodontal disease and pregnancy outcomes like preterm birth and low birth weight. Interviewer-administered questionnaires were completed by the subjects who attended the antenatal clinic of the Lagos University Teaching Hospital, Lagos. Information obtained included; maternal age, gestational age, marital status, educational status, occupation and expected date of delivery. After delivery, the questionnaire was completed with baby's weight at birth and the actual date of delivery. Clinical assessment of the periodontium was done using Oral Hygiene Index (OHI) and Community Periodontal Index of Treatment Needs (CPITN). Participants were divided into three groups: Test, Control I and Control II groups. Scaling and polishing were done for all patients with periodontal disease before (Test group) and after delivery (Control I). All Control II participants (those without periodontal disease) were given Oral hygiene instructions. Descriptive and comparative analyses were done using Epi info version 2008. Four hundred and fifty women received the questionnaire but the response rate was 94%, giving an actual sample size of 423 participants. Maternal age range was between 18 and 34 years with mean age of 29.67 (± 3.37). Gestational age at the point of recruitment was between 10 weeks and 26 weeks with mean of 23.34 (± 4.05). The prevalence of periodontal disease among the study group was 33.38%. About 71% of the participants attained tertiary level of education; only 0.7% had no formal education. There was 9.9% use of alcohol among the participants. The mean oral hygiene score for the participants was 1.94 (± 1.31). The prevalences for preterm deliveries, low birth weight and spontaneous abortion were 12.5%, 12.1% and 1.42% respectively. This study confirms periodontal disease as a probable risk for adverse pregnancy outcomes such as preterm delivery and low birth weight. Therefore, health workers should be encouraged to promote good

  4. Outcomes in type 1 diabetic pregnancies: a nationwide, population-based study

    DEFF Research Database (Denmark)

    Jensen, Dorte; Damm, Peter; Moelsted-Pedersen, Lars

    2004-01-01

    The aim of this study was to compare pregnancy outcomes in type 1 diabetic pregnancies with the background population.......The aim of this study was to compare pregnancy outcomes in type 1 diabetic pregnancies with the background population....

  5. Patient-reported allergies predict postoperative outcomes and psychosomatic markers following spine surgery.

    Science.gov (United States)

    Xiong, David D; Ye, Wenda; Xiao, Roy; Miller, Jacob A; Mroz, Thomas E; Steinmetz, Michael P; Nagel, Sean J; Machado, Andre G

    2018-05-22

    Prior studies have shown that patient-reported allergies can be prognostic of poorer postoperative outcomes. To investigate the correlation between self-reported allergies and outcomes after cervical or lumbar spine surgery. Retrospective cohort study at a single tertiary-care institution. All patients undergoing cervical or lumbar spine surgery from 2009-2014. The primary outcome measure was change in the EuroQol-5 Dimensions (EQ-5D) following surgery. Secondary outcomes included change in the Pain Disability Questionnaire (PDQ) and Patient Health Questionnaire-9 (PHQ-9), achieving the minimal clinically important difference (MCID) in these measures, as well as cost of admission. Prior to and following surgery, EQ-5D, PDQ, and PHQ-9 were recorded for patients with available data. Paired student's t-tests were used to compare change in these measures following surgery. Multivariable linear and logistic regression were used to assess the relationship between the log transformation of the total number of allergies and outcomes. 592 cervical patients and 4,465 lumbar patients were included. The median number of reported allergies was two. The EQ-5D index increased from 0.539 to 0.703 for cervical patients and from 0.530 to 0.676 for lumbar patients (pallergies predicted significantly higher odds of achieving the PDQ MCID (OR = 2.09, 95% CI 1.05-4.15, p=0.02 for cervical patients; OR = 1.30, 95% CI 1.03-1.68, p=0.03 for lumbar patients). However, this relationship was not durable for patients with follow-up exceeding 1 year. The log transformation of number of allergies for lumbar patients predicted significantly increased cost of admission (β=$3,597, pallergies correlate with subjective improvement in pain and disability following spine surgery and may serve as a marker of postoperative outcomes. The relationship between allergies and PDQ improvement may be secondary to the short-term expectation-actuality discrepancy, as this relationship was not durable beyond 1

  6. Outcome of pregnancy in the Grandmultipara in Enugu, Nigeria ...

    African Journals Online (AJOL)

    Non-use of antenatal services and delay in referral worsen pregnancy outcome. Formal education, campaign against large families, reduction in childhood mortalities and improvement in use of family planning will reduce its incidence while use of hospital services will improve pregnancy outcome. Early referral, team work ...

  7. 6. Outcomes and Factors Associated with Adolescent Pregnancies ...

    African Journals Online (AJOL)

    user

    ABSTRACT. Objectives: These were to determine obstetric outcomes associated with adolescent pregnancies and those of older women at the UTH, identify factors associated with and compare the obstetric outcomes between the two age groups with determining the scale of adolescent pregnancy. Materials and methods: ...

  8. Poor pregnancy outcome in women with type 2 diabetes

    DEFF Research Database (Denmark)

    Clausen, Tine Dalsgaard; Mathiesen, Elisabeth Reinhardt; Ekbom, Pia

    2005-01-01

    To evaluate the perinatal outcome and the frequency of maternal complications in pregnancies of women with type 2 diabetes during 1996-2001.......To evaluate the perinatal outcome and the frequency of maternal complications in pregnancies of women with type 2 diabetes during 1996-2001....

  9. Are patient-reported outcomes predictive of patient satisfaction 5 years after anterior cervical spine surgery?

    Science.gov (United States)

    Schroeder, Gregory D; Coric, Dom; Kim, Han Jo; Albert, Todd J; Radcliff, Kris E

    2017-07-01

    Patient satisfaction is becoming an increasing common proxy for surgical quality; however, the correlation between patient satisfaction and surgical outcomes 2 and 5 years after anterior cervical surgery has not been evaluated. The study aimed to determine if patient satisfaction is predicted by improvement in patient-reported outcomes (PRO) 2 and 5 years after anterior cervical spine surgery. This is a retrospective analysis of prospectively collected data. The sample included patients enrolled in the Food and Drug Administration investigational device exemption clinical trial comparing total disc replacement with Mobi-C cervical artificial disc and anterior cervical discectomy and fusion. The outcome measures were visual analog scale (VAS) neck pain score, Neck Disability Index (NDI), and Short-Form 12-Item scores, as well as patient satisfaction. Receiver operating characteristic curves were used to determine if improvement in different PRO metrics can accurately identify patient satisfaction. Additionally, a logistic regression analysis was performed on the results at 24 months and 60 months to identify independent predictors of patient satisfaction. This research was supported by LDR (Zimmer Biomet) 13785 Research Boulevard - Suite 200 Austin, TX 78750. Data were available for 512 patients at 60 months. At 24 months postoperatively, NDI score improvement (area under the curve [AUC]=0.806), absolute NDI score (AUC=0.823), and absolute VAS neck pain score (AUC=0.808) were all excellent predictors of patient satisfaction. At 60 months postoperatively, NDI score improvement (AUC=0.815), absolute NDI score (AUC=0.839), VAS neck pain score improvement (AUC=0.803), and absolute VAS neck pain score (AUC=0.861) were all excellent predictors of patient satisfaction. In patients undergoing one- and two-level anterior cervical spine surgery, between 2 and 5 years postoperatively, patient satisfaction is significantly predicted by PROs, including the VAS neck score and the

  10. 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

  11. β-Blocker treatment during pregnancy and adverse pregnancy outcomes

    DEFF Research Database (Denmark)

    Petersen, Kasper Meidahl; Jimenez-Solem, Espen; Andersen, Jon Traerup

    2012-01-01

    To investigate the association between exposure to β-blockers during pregnancy and the risk of being born small for gestational age (SGA), preterm birth and perinatal mortality in a nationwide cohort.......To investigate the association between exposure to β-blockers during pregnancy and the risk of being born small for gestational age (SGA), preterm birth and perinatal mortality in a nationwide cohort....

  12. Pregnancy outcome following gestational exposure to azithromycin

    Directory of Open Access Journals (Sweden)

    Woodland C Cindy

    2006-05-01

    Full Text Available Abstract Background Azithromycin is an azalide antibiotic with an extensive range of indications and has become a common treatment option due to its convenient dosing regimen and therapeutic advantages. Human studies addressing gestational use of azithromycin have primarily focused on antibiotic efficacy rather than fetal safety. Our primary objective was to evaluate the possibility of teratogenic risk following gestational exposure to azithromycin. Methods There were 3 groups of pregnant women enrolled in our study: 1 women who took azithromycin. 2 women exposed to non-teratogenic antibiotics for similar indications, and 3 women exposed to non-teratogenic agents. They were matched for gestational age at time of call, maternal age, cigarette and alcohol consumption. Rates of major malformations and other endpoints of interest were compared among the three groups. Results Pregnancy outcome of 123 women in each group was ascertained. There were no statistically significant differences among the three groups in the rates of major malformations; 3.4% (exposed versus 2.3% (disease matched and 3.4% (non teratogen or any other endpoints that were examined. In the azithromycin group, 88 (71.6% women took the drug during the first trimester Conclusion Results suggest that gestational exposure to azithromycin is not associated with an increase in the rate of major malformations above the baseline of 1–3%. Our data adds to previous research showing that macrolide antibiotics, as a group, are generally safe in pregnancy and provides an evidence-based option for health professionals caring for populations with chlamydia.

  13. Interviewing to develop Patient-Reported Outcome (PRO) measures for clinical research: eliciting patients’ experience

    Science.gov (United States)

    2014-01-01

    Patient-reported outcome (PRO) measures must provide evidence that their development followed a rigorous process for ensuring their content validity. To this end, the collection of data is performed through qualitative interviews that allow for the elicitation of in-depth spontaneous reports of the patients’ experiences with their condition and/or its treatment. This paper provides a review of qualitative research applied to PRO measure development. A clear definition of what is a qualitative research interview is given as well as information about the form and content of qualitative interviews required for developing PRO measures. Particular attention is paid to the description of interviewing approaches (e.g., semi-structured and in-depth interviews, individual vs. focus group interviews). Information about how to get prepared for a qualitative interview is provided with the description of how to develop discussion guides for exploratory or cognitive interviews. Interviewing patients to obtain knowledge regarding their illness experience requires interpersonal and communication skills to facilitate patients’ expression. Those skills are described in details, as well as the skills needed to facilitate focus groups and to interview children, adolescents and the elderly. Special attention is also given to quality assurance and interview training. The paper ends on ethical considerations since interviewing for the development of PROs is performed in a context of illness and vulnerability. Therefore, it is all the more important that, in addition to soliciting informed consent, respectful interactions be ensured throughout the interview process. PMID:24499454

  14. Use of Diabetes Treatment Satisfaction Questionnaire in Diabetes Care: Importance of Patient-Reported Outcomes

    Directory of Open Access Journals (Sweden)

    Yoshifumi Saisho

    2018-05-01

    Full Text Available The efficacy of diabetes treatment should not be evaluated solely by HbA1c levels as they should also focus on patient-reported outcomes (PROs, such as patient satisfaction, wellbeing and quality of life. The Diabetes Treatment Satisfaction Questionnaire (DTSQ has been developed to assess patient satisfaction with diabetes treatment. DTSQ has been translated into more than 100 languages and is widely used in many countries, since it is relatively easy to answer and is used for both patients with and without medical therapy. Novel therapeutic options, such as insulin analogs, incretin-based therapy and sodium-glucose cotransporter 2 (SGLT2 inhibitors, have been shown to improve patient satisfaction using DTSQ for assessments. DTSQ is not only used for comparisons between different medications or treatment strategies, but also can be used to assess the quality of diabetes care in clinical settings. This is important as an improvement in treatment satisfaction may enhance patients’ self-efficacy and adherence to therapy, leading to the achievement of long-term stable glycemic control and reduced risk of diabetic complications. In this review, we summarize the current topics in DTSQ, introducing our own experience, and discuss the role of PROs in diabetes treatment.

  15. The Influence of Obesity on Patient Reported Outcomes following Total Knee Replacement

    Directory of Open Access Journals (Sweden)

    Vandana Ayyar

    2012-01-01

    Full Text Available This study retrospectively analysed the effects of obesity as described by Body Mass Index (BMI on patient reported outcomes following total knee replacement. Participants (105 females and 66 males who had undergone surgery under the care of a single surgeon were included in the review and were grouped according to their preoperative BMI into nonobese ( kg/m2, ( obese ( kg/m2 (. Oxford Knee Score (OKS and Short Form 12 scores (SF12 were taken preoperatively and 6 and 12 months after surgery to analyse differences between groups in the absolute scores as well as changes from before to after surgery. Preoperatively, the obese group had a significantly poorer OKS compared to non obese (44.7 versus 41.2, . There were no statistically significant group effects on follow-up or change scores of the OKS and SF12. Correlations coefficients between BMI and follow-up and change scores were low (. There were no significant differences in the number of complications and revisions (local wound infection, 6.7% non obese, 11% obese, postoperative systemic complication, 8% non obese, 12% obese, revision, 4% nonobese, 3% obese. In conclusion, our findings indicate similar degrees of benefits from the surgery irrespective of patient BMI.

  16. Analyzing differences between patient and proxy on Patient Reported Outcomes in multiple sclerosis.

    Science.gov (United States)

    Sonder, Judith M; Holman, Rebecca; Knol, Dirk L; Bosma, Libertje V A E; Polman, Chris H; Uitdehaag, Bernard M J

    2013-11-15

    Proxy respondents, partners of multiple sclerosis (MS) patients, can provide valuable information on the MS patients' disease. In an earlier publication we found relatively good agreement on patient reported outcomes (PROs) measuring physical impact and functioning, but we found large differences on (neuro)psychological scales. We aim to identify patient and proxy related variables explaining differences between patients' and proxies' ratings on five PROs. We report on data from 175 MS patients and proxy respondents. Regression analyses were performed, using as dependent variable the mean differences on five scales: Physical and Psychological scale of the Multiple Sclerosis Impact Scale (MSIS-29), the Multiple Sclerosis Walking Scale (MSWS), Guy's Neurological Disability Scale (GNDS) and the Multiple Sclerosis Neuropsychological Screening Questionnaire (MSNQ). The independent variables were patient, proxy and disease related variables. Caregiver strain was significantly related to differences between patient and proxy scores for all five PROs. A higher level of patient anxiety on the HADS was linked to larger differences on all PROs except the GNDS. In addition, cognitive functioning, proxy depression, walking ability, proxy gender and MS related disability were contributing to the discrepancies. We found several patient and proxy factors that may contribute to discrepancies between patient and proxy scores on MS PROs. The most important factor is caregiver burden. © 2013 Elsevier B.V. All rights reserved.

  17. Collecting, Integrating, and Disseminating Patient-Reported Outcomes for Research in a Learning Healthcare System.

    Science.gov (United States)

    Harle, Christopher A; Lipori, Gloria; Hurley, Robert W

    2016-01-01

    Advances in health policy, research, and information technology have converged to increase the electronic collection and use of patient-reported outcomes (PROs). Therefore, it is important to share lessons learned in implementing PROs in research information systems. The purpose of this case study is to describe a novel information system for electronic PROs and lessons learned in implementing that system to support research in an academic health center. The system incorporates freely available and commercial software and involves clinical and research workflows that support the collection, transformation, and research use of PRO data. The software and processes that comprise the system serve three main functions, (i) collecting electronic PROs in clinical care, (ii) integrating PRO data with non-patient generated clinical data, and (iii) disseminating data to researchers through the institution's research informatics infrastructure, including the i2b2 (Informatics for Integrating Biology and the Bedside) system. Our successful design and implementation was driven by three overarching strategies. First, we selected and implemented multiple interfaced technologies to support PRO collection, management, and research use. Second, we aimed to use standardized approaches to measuring PROs, sending PROs between systems, and disseminating PROs. Finally, we focused on using technologies and processes that aligned with existing clinical research information management strategies within our organization. These experiences and lessons may help future implementers and researchers enhance the scale and sustainable use of systems for research use of PROs.

  18. 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.

  19. 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

  20. Electronic Patient Reported Outcomes in Paediatric Oncology - Applying Mobile and Near Field Communication Technology.

    Science.gov (United States)

    Duregger, Katharina; Hayn, Dieter; Nitzlnader, Michael; Kropf, Martin; Falgenhauer, Markus; Ladenstein, Ruth; Schreier, Günter

    2016-01-01

    Electronic Patient Reported Outcomes (ePRO) gathered using telemonitoring solutions might be a valuable source of information in rare cancer research. The objective of this paper was to develop a concept and implement a prototype for introducing ePRO into the existing neuroblastoma research network by applying Near Field Communication and mobile technology. For physicians, an application was developed for registering patients within the research network and providing patients with an ID card and a PIN for authentication when transmitting telemonitoring data to the Electronic Data Capture system OpenClinica. For patients, a previously developed telemonitoring system was extended by a Simple Object Access Protocol (SOAP) interface for transmitting nine different health parameters and toxicities. The concept was fully implemented on the front-end side. The developed application for physicians was prototypically implemented and the mobile application of the telemonitoring system was successfully connected to OpenClinica. Future work will focus on the implementation of the back-end features.

  1. Standards for Clinical Trials in Male and Female Sexual Dysfunction: II. Patient-Reported Outcome Measures.

    Science.gov (United States)

    Fisher, William A; Gruenwald, Ilan; Jannini, Emmanuele A; Lev-Sagie, Ahinoam; Lowenstein, Lior; Pyke, Robert E; Reisman, Yakov; Revicki, Dennis A; Rubio-Aurioles, Eusebio

    2016-12-01

    The second article in this series, Standards for Clinical Trials in Male and Female Sexual Dysfunction, focuses on measurement of patient-reported outcomes (PROs). Together with the design of appropriate phase I to phase IV clinical trials, the development, validation, choice, and implementation of valid PRO measurements-the focus of the present article-form the foundation of research on treatments for male and female sexual dysfunctions. PRO measurements are assessments of any aspect of a patient's health status that come directly from the patient (ie, without the interpretation of the patient's responses by a physician or anyone else). PROs are essential for assessing male and female sexual dysfunction and treatment response, including symptom frequency and severity, personal distress, satisfaction, and other measurements of sexual and general health-related quality of life. Although there are some relatively objective measurements of sexual dysfunction (ie, intravaginal ejaculatory latency time, frequency of sexual activity, etc), these measurements do not comprehensively assess the occurrence and extent of sexual dysfunction or treatment on the patient's symptoms, functioning, and well-being. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient's perspective. Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

  2. 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.

  3. Pragmatic characteristics of patient-reported outcome measures are important for use in clinical practice.

    Science.gov (United States)

    Kroenke, Kurt; Monahan, Patrick O; Kean, Jacob

    2015-09-01

    Measures for assessing patient-reported outcomes (PROs) that may have initially been developed for research are increasingly being recommended for use in clinical practice as well. Although psychometric rigor is essential, this article focuses on pragmatic characteristics of PROs that may enhance uptake into clinical practice. Three sources were drawn on in identifying pragmatic criteria for PROs: (1) selected literature review including recommendations by other expert groups; (2) key features of several model public domain PROs; and (3) the authors' experience in developing practical PROs. Eight characteristics of a practical PRO include: (1) actionability (i.e., scores guide diagnostic or therapeutic actions/decision making); (2) appropriateness for the relevant clinical setting; (3) universality (i.e., for screening, severity assessment, and monitoring across multiple conditions); (4) self-administration; (5) item features (number of items and bundling issues); (6) response options (option number and dimensions, uniform vs. varying options, time frame, intervals between options); (7) scoring (simplicity and interpretability); and (8) accessibility (nonproprietary, downloadable, available in different languages and for vulnerable groups, and incorporated into electronic health records). Balancing psychometric and pragmatic factors in the development of PROs is important for accelerating the incorporation of PROs into clinical practice. Published by Elsevier Inc.

  4. Prolonged pregnancy: Methods, Causal Determinants and Outcome

    DEFF Research Database (Denmark)

    Olesen, Annette Wind

    Summary Prolonged pregnancy, defined as a pregnancy with a gestational length of 294 days or more, is a frequent condition. It is associated with an increased risk of fetal and maternal complications. Little is known about the aetiology of prolonged pregnancy. The aims of the thesis were 1......) to study the incidence of prolonged pregnancy as a function of methods for determining gestational age; 2) to determine the risk of obstetrical and fetal complications in prolonged pregnancy; 3) to validate the self-reported gestational age in the National Birth Cohort; 4) to determine whether...... the risk of recurrence of prolonged pregnancy as a function of change in male partner and social conditions (IV). The National Birth Cohort provided data for the study on prenatal risk indicators of prolonged pregnancy in a follow-up design (V). The self-reported gestational ages from this database...

  5. Periodontal disease and pregnancy outcomes: time to move on?

    Science.gov (United States)

    Srinivas, Sindhu K; Parry, Samuel

    2012-02-01

    Maternal periodontal disease is a highly prevalent condition that has been studied extensively in relation to adverse pregnancy outcomes, including preterm delivery, preeclampsia, and low birth weight. Investigators speculate that hematogenous transport of bacteria and/or pro-inflammatory mediators from sites of periodontal infection into the placenta, fetal membranes, and amniotic cavity induces pathological processes that lead to these adverse outcomes. Preliminary observational studies supported this hypothesis, but more recent work by our group and others do not demonstrate an increased risk of adverse pregnancy outcomes among women with periodontal disease, and most randomized trials fail to demonstrate improved perinatal outcomes following treatment of periodontal disease in pregnancy.

  6. Symptom recovery after thoracic surgery: Measuring patient-reported outcomes with the MD Anderson Symptom Inventory.

    Science.gov (United States)

    Fagundes, Christopher P; Shi, Qiuling; Vaporciyan, Ara A; Rice, David C; Popat, Keyuri U; Cleeland, Charles S; Wang, Xin Shelley

    2015-09-01

    Measuring patient-reported outcomes (PROs) has become increasingly important for assessing quality of care and guiding patient management. However, PROs have yet to be integrated with traditional clinical outcomes (such as length of hospital stay), to evaluate perioperative care. This study aimed to use longitudinal PRO assessments to define the postoperative symptom recovery trajectory in patients undergoing thoracic surgery for lung cancer. Newly diagnosed patients (N = 60) with stage I or II non-small cell lung cancer who underwent either standard open thoracotomy or video-assisted thoracoscopic surgery lobectomy reported multiple symptoms from before surgery to 3 months after surgery, using the MD Anderson Symptom Inventory. We conducted Kaplan-Meier analyses to determine when symptoms returned to presurgical levels and to mild-severity levels during recovery. The most-severe postoperative symptoms were fatigue, pain, shortness of breath, disturbed sleep, and drowsiness. The median time to return to mild symptom severity for these 5 symptoms was shorter than the time to return to baseline severity, with fatigue taking longer. Recovery from pain occurred more quickly for patients who underwent lobectomy versus thoracotomy (8 vs 18 days, respectively; P = .022). Patients who had poor preoperative performance status or comorbidities reported higher postoperative pain (all P < .05). Assessing symptoms from the patient's perspective throughout the postoperative recovery period is an effective strategy for evaluating perioperative care. This study demonstrates that the MD Anderson Symptom Inventory is a sensitive tool for detecting symptomatic recovery, with an expected relationship among surgery type, preoperative performance status, and comorbid conditions. Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

  7. 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.

  8. Patient-Reported Outcomes in Latin America: Implementation in Research and Role in Emerging HTA Systems.

    Science.gov (United States)

    Winnette, Randall; Zárate, Victor; Machnicki, Gerardo; DeMuro, Carla; Gawlicki, Mary; Gnanasakthy, Ari

    2015-12-01

    Patient-reported outcomes (PROs) are increasingly used to demonstrate the value of interventions and support health technology assessment (HTA). The objective of this work was to analyze trends regarding PROs in Latin America (LatAm), highlight challenges in the application of PROs in this region, and suggest solutions. A team of researchers with expertise in PROs conducted a nonsystematic PubMed literature search pertaining to the use of PROs in LatAm. The experts also drew on their experience working with PROs to assess the application of PROs in LatAm. The literature search yielded more than 4000 publications, with an increasing publication rate in recent years. PROs are being used in LatAm in various study types: instrument validation, phase III international clinical trials, health service research. A large Inter-American Development Bank study demonstrates the growing importance of PROs in the region. The growth in local value sets for the EuroQol five-dimensional questionnaire in LatAm reflects the regional emergence of HTA systems. Operational challenges relate to ensuring the use of good-quality questionnaires that, at a minimum, have undergone appropriate cultural adaptation and ideally have established psychometric properties. PROs are increasingly important in LatAm. Future efforts should aim to strengthen the operational and research infrastructure around PROs in the region. Innovation should be encouraged, including studying alternative methods of eliciting health utilities for economic evaluation. A wider scope around PRO uses for decision making by HTA bodies is an international trend with potential positive prospects in LatAm. Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  9. Effect of an Immersive Preoperative Virtual Reality Experience on Patient Reported Outcomes: A Randomized Controlled Trial.

    Science.gov (United States)

    Bekelis, Kimon; Calnan, Daniel; Simmons, Nathan; MacKenzie, Todd A; Kakoulides, George

    2017-06-01

    To investigate the effect of exposure to a virtual reality (VR) environment preoperatively on patient-reported outcomes for surgical operations. There is a scarcity of well-developed quality improvement initiatives targeting patient satisfaction. We performed a randomized controlled trial of patients undergoing cranial and spinal operations in a tertiary referral center. Patients underwent a 1:1 randomization to an immersive preoperative VR experience or standard preoperative experience stratified on type of operation. The primary outcome measures were the Evaluation du Vecu de l'Anesthesie Generale (EVAN-G) score and the Amsterdam Preoperative Anxiety and Information (APAIS) score, as markers of the patient's experience during the surgical encounter. During the study period, a total of 127 patients (mean age 55.3 years, 41.9% females) underwent randomization. The average EVAN-G score was 84.3 (standard deviation, SD, 6.4) after VR, and 64.3 (SD, 11.7) after standard preoperative experience (difference, 20.0; 95% confidence interval, CI, 16.6-23.3). Exposure to an immersive VR experience also led to higher APAIS score (difference, 29.9; 95% CI, 24.5-35.2). In addition, VR led to lower preoperative VAS stress score (difference, -41.7; 95% CI, -33.1 to -50.2), and higher preoperative VAS preparedness (difference, 32.4; 95% CI, 24.9-39.8), and VAS satisfaction (difference, 33.2; 95% CI, 25.4-41.0) scores. No association was identified with VAS stress score (difference, -1.6; 95% CI, -13.4 to 10.2). In a randomized controlled trial, we demonstrated that patients exposed to preoperative VR had increased satisfaction during the surgical encounter. Harnessing the power of this technology, hospitals can create an immersive environment that minimizes stress, and enhances the perioperative experience.

  10. Delivery of Patient-Reported Outcome Instruments by Automated Mobile Phone Text Messaging.

    Science.gov (United States)

    Anthony, Christopher A; Lawler, Ericka A; Glass, Natalie A; McDonald, Katelyn; Shah, Apurva S

    2017-11-01

    Patient-reported outcome (PRO) instruments allow patients to interpret their health and are integral in evaluating orthopedic treatments and outcomes. The purpose of this study was to define: (1) correlation between PROs collected by automated delivery of text messages on mobile phones compared with paper delivery; and (2) patient use characteristics of a technology platform utilizing automated delivery of text messages on mobile phones. Paper versions of the 12-Item Short Form Health Survey (SF-12) and the short form of the Disabilities of the Arm, Shoulder and Hand (QuickDASH) were completed by patients in orthopedic hand and upper extremity clinics. Over the next 48 hours, the same patients also completed the mobile phone portion of the study outside of the clinic which included text message delivery of the SF-12 and QuickDASH, assigned in a random order. Correlations between paper and text message delivery of the 2 PROs were assessed. Among 72 patients, the intraclass correlation coefficient (ICC) between the written and mobile phone delivery of QuickDASH was 0.91 (95% confidence interval [CI], 0.85-0.95). The ICC between the paper and mobile phone delivery of the SF-12 physical health composite score was 0.88 (95% CI, 0.79-0.93) and 0.86 (95% CI, 0.75-0.92) for the SF-12 mental health composite score. We find that text message delivery using mobile phones permits valid assessment of SF-12 and QuickDASH scores. The findings suggest that software-driven automated delivery of text communication to patients via mobile phones may be a valid method to obtain other PRO scores in orthopedic patients.

  11. [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.

  12. Comparison of CTT and Rasch-based approaches for the analysis of longitudinal Patient Reported Outcomes.

    Science.gov (United States)

    Blanchin, Myriam; Hardouin, Jean-Benoit; Le Neel, Tanguy; Kubis, Gildas; Blanchard, Claire; Mirallié, Eric; Sébille, Véronique

    2011-04-15

    Health sciences frequently deal with Patient Reported Outcomes (PRO) data for the evaluation of concepts, in particular health-related quality of life, which cannot be directly measured and are often called latent variables. Two approaches are commonly used for the analysis of such data: Classical Test Theory (CTT) and Item Response Theory (IRT). Longitudinal data are often collected to analyze the evolution of an outcome over time. The most adequate strategy to analyze longitudinal latent variables, which can be either based on CTT or IRT models, remains to be identified. This strategy must take into account the latent characteristic of what PROs are intended to measure as well as the specificity of longitudinal designs. A simple and widely used IRT model is the Rasch model. The purpose of our study was to compare CTT and Rasch-based approaches to analyze longitudinal PRO data regarding type I error, power, and time effect estimation bias. Four methods were compared: the Score and Mixed models (SM) method based on the CTT approach, the Rasch and Mixed models (RM), the Plausible Values (PV), and the Longitudinal Rasch model (LRM) methods all based on the Rasch model. All methods have shown comparable results in terms of type I error, all close to 5 per cent. LRM and SM methods presented comparable power and unbiased time effect estimations, whereas RM and PV methods showed low power and biased time effect estimations. This suggests that RM and PV methods should be avoided to analyze longitudinal latent variables. Copyright © 2010 John Wiley & Sons, Ltd.

  13. Assessment of Patient-Reported Outcome Instruments to Assess Chronic Low Back Pain.

    Science.gov (United States)

    Ramasamy, Abhilasha; Martin, Mona L; Blum, Steven I; Liedgens, Hiltrud; Argoff, Charles; Freynhagen, Rainer; Wallace, Mark; McCarrier, Kelly P; Bushnell, Donald M; Hatley, Noël V; Patrick, Donald L

    2017-06-01

     To identify patient-reported outcome (PRO) instruments that assess chronic low back pain (cLBP) symptoms (specifically pain qualities) and/or impacts for potential use in cLBP clinical trials to demonstrate treatment benefit and support labeling claims.  Literature review of existing PRO measures.  Publications detailing existing PRO measures for cLBP were identified, reviewed, and summarized. As recommended by the US Food & Drug Administration (FDA) PRO development guidance, standard measurement characteristics were reviewed, including development history, psychometric properties (validity and reliability), ability to detect change, and interpretation of observed changes.  Thirteen instruments were selected and reviewed: Low Back Pain Bothersomeness Scale, Neuropathic Pain Symptom Inventory, PainDETECT, Pain Quality Assessment Scale Revised, Revised Short Form McGill Pain Questionnaire, Low Back Pain Impact Questionnaire, Oswestry Disability Index, Pain Disability Index, Roland-Morris Disability Questionnaire, Brief Pain Inventory and Brief Pain Inventory Short Form, Musculoskeletal Outcomes Data Evaluation and Management System Spine Module, Orebro Musculoskeletal Pain Questionnaire, and the West Haven-Yale Multidimensional Pain Inventory Interference Scale. The instruments varied in the aspects of pain and/or impacts that they assessed, and none of the instruments fulfilled all criteria for use in clinical trials to support labeling claims based on recommendations outlined in the FDA PRO guidance.  There is an unmet need for a validated PRO instrument to evaluate cLBP-related symptoms and impacts for use in clinical trials. © 2017 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  14. Pectus patient information website has improved access to care and patient reported outcomes.

    Science.gov (United States)

    Tikka, Theofano; Webb, Joanne; Agostini, Paula; Kerr, Amy; Mannion, Glenn; Steyn, Richard S; Bishay, Ehab; Kalkat, Maninder S; Rajesh, Pala B; Naidu, Babu

    2016-04-26

    Pectus is the most common congenital disorder. Awareness amongst primary care physicians and the general public is poor. NHS commissioning bodies plan to withdraw funding for this surgery because they deem a lack of sufficient evidence of benefit. The purpose of this study is to assess the effects of introducing a patient information website on referral and activity patterns and on patients reported outcomes. We produced an innovative information website, www.pectus.co.uk , accessible to the general public, providing information about pectus deformities; management options and advice about surgery. Referral patterns and number of cases where studied before and after the introduction of the website in 2010. Patients' satisfaction post-op was assessed using the Brompton's single step questionnaire (SSQ). The website had considerable traffic with 2179 hits in 2012, 4983 in 2013 and 7416 in 2014. This has led to 1421 contacts and 372 email enquiries. These emails have resulted in an increased number of patients who have been assessed and go on to have surgery. We asked 59 pectus excavatum patients who were operated from 2008 to 2014 to complete the SSQ. We received 32 replies. Eighty-four percent (16/19) of patients who visited the website and then underwent surgery, found the website useful. All patients scored satisfactorily in SSQ. Even though those who visited the website tended to be more satisfied with the surgical outcomes this did not reach statistical significance. This group of patients said that would have the operation again given the option compared to 76.9 % of the group who did not visit the website before surgery (p=0.031). Despite the fact that patients who visited the website experienced more post-operative complications were equally or more satisfied with post-operative outcomes. The overall SSQ obtainable score was not different for the two subgroups, being more widespread in the group that did not visit the website. The introduction of a pectus

  15. 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.

  16. Patient-reported outcomes 5 years after laser in situ keratomileusis.

    Science.gov (United States)

    Schallhorn, Steven C; Venter, Jan A; Teenan, David; Hannan, Stephen J; Hettinger, Keith A; Pelouskova, Martina; Schallhorn, Julie M

    2016-06-01

    To assess vision-related, quality-of-life outcomes 5 years after laser in situ keratomileusis (LASIK) and determine factors predictive of patient satisfaction. Optical Express, Glasgow, Scotland. Retrospective case series. Data from patients who had attended a clinical examination 5 years after LASIK were analyzed. All treatments were performed using the Visx Star S4 IR excimer laser. Patient-reported satisfaction, the effect of eyesight on various activities, visual phenomena, and ocular discomfort were evaluated 5 years postoperatively. Multivariate regression analysis was performed to determine factors affecting patient satisfaction. The study comprised 2530 patients (4937 eyes) who had LASIK. The mean age at the time of surgery was 42.4 years ± 12.5 (SD), and the preoperative manifest spherical equivalent ranged from -11.0 diopters (D) to +4.88 D. Five years postoperatively, 79.3% of eyes were within ±0.50 D of emmetropia and 77.7% of eyes achieved monocular uncorrected distance visual acuity (UDVA) and 90.6% of eyes achieved binocular UDVA of 20/20 or better. Of the patients, 91.0% said they were satisfied with their vision and 94.9% did not wear distance correction. Less than 2.0% of patients noticed visual phenomena, even with spectacle correction. Major predictors of patient satisfaction 5 years postoperatively were postoperative binocular UDVA (37.6% variance explained by regression model), visual phenomena (relative contribution of 15.0%), preoperative and postoperative sphere and their interactions (11.6%), and eyesight-related difficulties with various activities such as night driving, outdoor activities, and reading (10.2%). Patient-reported quality-of-life and satisfaction rates remained high 5 years after LASIK. Uncorrected vision was the strongest predictor of satisfaction. Dr. S.C. Schallhorn is a consultant to Abbott Medical Optics, Inc., Zeiss Meditec AG, and Autofocus Inc. and a global medical director for Optical Express. No other

  17. Twin versus singleton pregnancies: the incidence, pregnancy complications, and obstetric outcomes in a Nigerian tertiary hospital.

    Science.gov (United States)

    Obiechina, Nj; Okolie, Ve; Eleje, Gu; Okechukwu, Zc; Anemeje, Oa

    2011-01-01

    Twin pregnancy is associated with more pregnancy complications and poorer pregnancy outcome than singleton pregnancy. Hence periodic review is necessary to improve on the pregnancy outcome. To determine the incidence and compare pregnancy complications and obstetric outcomes of twin pregnancies and singleton pregnancies. The twin pregnancies (study group) that were delivered at Nnamdi Azikiwe University Teaching Hospital (NAUTH), Nnewi, South-East Nigeria from 1st February 2005 to 31st January 2010 were compared with singleton deliveries (control group) that occurred in the same hospital during the same period. A total of 3351 deliveries were conducted during the study period, of which 113 were twin deliveries, giving an incidence of 1:29.6 deliveries. Only 100 case files could be retrieved for analysis. The mean parities for the twins and singletons were 2.7 ± 2.33 weeks and 1.96 ± 1.87 weeks whereas the mean gestational age at delivery for twin and singleton deliveries were 34 ± 5.2 weeks and 38.7 ± 2.4 weeks respectively (P < 0.05). The mean birth weights were 3.14 ± 0.73 kg and 2.3 ± 1.0 kg for singletons and twins respectively (P < 0.05). Hypertensive disorders of pregnancy, cord prolapse, malpresentation, premature rupture of membranes, low Apgar scores, cesarean section rate, and perinatal death were significantly higher in twin pregnancies than in singleton. The incidence of twin pregnancy over the study period was high and was significantly associated with more pregnancy complications and poorer obstetric outcomes. Close antenatal and intrapartum care are needed in order to improve outcome and decrease complications.

  18. 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

  19. Social inequalities in patient-reported outcomes among older multimorbid patients--results of the MultiCare cohort study.

    Science.gov (United States)

    von dem Knesebeck, Olaf; Bickel, Horst; Fuchs, Angela; Gensichen, Jochen; Höfels, Susanne; Riedel-Heller, Steffi G; König, Hans-Helmut; Mergenthal, Karola; Schön, Gerhard; Wegscheider, Karl; Weyerer, Siegfried; Wiese, Birgitt; Scherer, Martin; van den Bussche, Hendrik; Schäfer, Ingmar

    2015-02-07

    In this article three research questions are addressed: (1) Is there an association between socioeconomic status (SES) and patient-reported outcomes in a cohort of multimorbid patients? (2) Does the association vary according to SES indicator used (income, education, occupational position)? (3) Can the association between SES and patient-reported outcomes (self-rated health, health-related quality of life and functional status) be (partly) explained by burden of disease? Analyses are based on the MultiCare Cohort Study, a German multicentre, prospective, observational cohort study of multimorbid patients from general practice. We analysed baseline data and data from the first follow-up after 15 months (N = 2,729). To assess burden of disease we used the patients' morbidity data from standardized general practitioner (GP) interviews based on a list of 46 groups of chronic conditions including the GP's severity rating of each chronic condition ranging from marginal to very severe. In the cross-sectional analyses SES was significantly associated with the patient-reported outcomes at baseline. Associations with income were more consistent and stronger than with education and occupational position. Associations were partly explained (17% to 44%) by burden of disease. In the longitudinal analyses only income (but not education and occupational position) was significantly related to the patient-reported outcomes at follow-up. Associations between income and the outcomes were reduced by 18% to 27% after adjustment for burden of disease. Results indicate social inequalities in self-rated health, functional status and health related quality of life among older multimorbid patients. As associations with education and occupational position were inconsistent, these inequalities were mainly due to income. Inequalities were partly explained by burden of disease. However, even among patients with a similar disease burden, those with a low income were worse off in terms of the

  20. Dichlorodiphenyltrichloroethane (DDT), DDT Metabolites and Pregnancy Outcomes

    Science.gov (United States)

    Kezios, Katrina L.; Liu, Xinhua; Cirillo, Piera M.; Cohn, Barbara A.; Kalantzi, Olga I.; Wang, Yunzhu; Petreas, Myrto X.; Park, June-Soo; Factor-Litvak, Pam

    2012-01-01

    Organochlorine pesticides (OCPs) are persistent endocrine disruptors. OCPs cross the placenta; this prenatal exposure has been associated with adverse pregnancy outcomes. We investigated associations between prenatal exposure to OCPs and gestational age and birth weight in 600 infants born between 1960 and 1963. The primary OCP was 1,1,1-trichloro-2,2-bis(p-chlorophenyl)ethane (p,p′-DDT), its primary metabolite, 1,1′-dichloro-2,2'-bis(p-chlorophenyl)ethylene(p,p′-DDE) and the contaminant, 1,1,1-trichloro-2-(p-chlorophenyl)-2-(o-chlorophenyl)-ethane (o,p′-DDT). Regression analysis indicated that for each natural log unit increase in p,p′-DDT, birth weight increased by 274 grams (95% CI 122, 425) when controlling for p,p′-DDE and o,p′-DDT. At a given level of p,p′-DDT exposure, o,p′-DDT and p,p′-DDE were associated with decreased birth weight. p,p′-DDE was negatively associated with length of gestation, controlling for p,p′-DDT and o,p′-DDT. These findings suggest opposing associations between exposure to p,p′-DDT and p,p′-DDE and birth weight. We did not find evidence to support mediation by maternal thyroid hormone status nor that the association differed by sex. PMID:23142753

  1. The establishment of the GENEQOL consortium to investigate the genetic disposition of patient-reported quality-of-life outcomes

    NARCIS (Netherlands)

    Sprangers, M.A.G.; Sloan, J.A.; Veenhoven, R.; Cleeland, C.S.; Halyard, M.Y.; Abertnethy, A.P.; Baas, F.; Barsevick, A.M.; Bartels, M.; Boomsma, D.I.; Chauhan, C.; Dueck, A.C.; Frost, M.H.; Hall, P.; Klepstad, P.; Martin, N.G.; Miaskowski, C.; Mosing, M.; Movsas, B.; van Noorden, C.J.F.; Patrick, D.L.; Pedersen, N.L.; Ropka, M.E.; Shi, Q.; Shinozaki, G.; Singh, J.A.; Yang, P.; Zwinderman, A.H.

    2009-01-01

    To our knowledge, no comprehensive, interdisciplinary initiatives have been taken to examine the role of genetic variants on patient-reported qualityof-life outcomes. The overall objective of this paper is to describe the establishment of an international and interdisciplinary consortium, the

  2. Development and implementation of a patient reported outcome intervention (QLIC-ON PROfile) in clinical paediatric oncology practice.

    NARCIS (Netherlands)

    Engelen, V.; Haverman, L.; Koopman, H.; Schouten-van Meeteren, N.; Meijer, E.M.M.; Vrijmoet-Wiersma, J.; Dijk, E.M. van; Last, B.; Detmar, S.; Grootenhuis, M.

    2010-01-01

    OBJECTIVE: The use of patient reported outcomes (PRO) in routine clinical practice is becoming increasingly common, but there is limited knowledge about the development and implementation of PRO. The objective of the current paper is to provide a thorough description of the development and

  3. Development and implementation of a patient reported outcome intervention (QLIC-ON PROfile) in clinical paediatric oncology practice

    NARCIS (Netherlands)

    Engelen, V.; Haverman, L.; Koopman, H.; Schouten-van Meeteren, A.Y.N.; Meijer-van den Bergh, E.; Vrijmoet-Wiersma, J.; van Dijk, E.M.; Last, B.F.; Detmar, S.; Grootenhuis, M.

    2010-01-01

    Objective: The use of patient reported outcomes (PRO) in routine clinical practice is becoming increasingly common, but there is limited knowledge about the development and implementation of PRO. The objective of the current paper is to provide a thorough description of the development and

  4. Patient-reported outcomes in Danish implantable cardioverter defibrillator patients with a Sprint Fidelis lead advisory notification

    DEFF Research Database (Denmark)

    Pedersen, Susanne S; Versteeg, Henneke; Nielsen, Jens Cosedis

    2011-01-01

    Few studies have investigated the association between implantable cardioverter defibrillators (ICDs) and lead advisory notifications and patient-reported outcomes (PROs). We examined (i) whether the mode used to inform patients about a device advisory is associated with PROs, and (ii) whether...... patients with a lead subject to a device advisory report poorer PROs than non-advisory controls....

  5. Patient-reported Outcomes after ADM-assisted Implant-based Breast Reconstruction: A Cross-sectional Study

    Directory of Open Access Journals (Sweden)

    Vera L. Negenborn, MD

    2018-02-01

    Conclusion:. There is an increased demand for patient-reported outcome measures in a changing practice to which the opinion of the patient assumes a larger role. With high satisfaction rates, ADM-assisted IBBR is a valuable reconstruction method, provided that complication rates remain low. Hence, it should only be performed in a selected group of women.

  6. Tofacitinib or adalimumab versus placebo: patient-reported outcomes from a phase 3 study of active rheumatoid arthritis

    NARCIS (Netherlands)

    Strand, Vibeke; van Vollenhoven, Ronald F.; Lee, Eun Bong; Fleischmann, Roy; Zwillich, Samuel H.; Gruben, David; Koncz, Tamas; Wilkinson, Bethanie; Wallenstein, Gene

    2016-01-01

    To evaluate effects of tofacitinib or adalimumab on patient-reported outcomes (PROs) in patients with moderate to severe RA and inadequate responses to MTX. In this 12-month, phase 3, randomized controlled trial (ORAL Standard), patients (n = 717) receiving background MTX were randomized to

  7. The establishment of the GENEQOL consortium to investigate the genetic disposition of patient reported quality-of-life outcomes

    NARCIS (Netherlands)

    M.A.G. Sprangers (Mirjam); J.A. Sloan (Jeff); R. Veenhoven (Ruut); C.S. Cleeland (Charles); M.Y. Halyard (Michele); A.P. Abertnethy (Amy); F. Baas (Frank); A.M. Barsevick (Andrea); M. Bartels (Meike); D.I. Boomsma (Dorret); C. Chauhan (Cynthia); A.C. Dueck (Amylou); M.H. Frost (Marlene); P. Hall (Per); P. Klepstad (Pal); N.G. Martin (Nicholas); C. Miaskowski (Christine); M. Mosing (Miriam); B. Movsas (Benjamin); C.J.F. van Noorden (Cornelis); D.L. Patrick (Donald); N.L. Pedersen (Nancy); M.E. Ropka (Mary); Q. Shi (Quiling); G. Shinozaki (Gen); J.A. Singh (Jasvinder); P. Yang (Ping); A.H. Zwinderman (Ailko)

    2009-01-01

    textabstractTo our knowledge, no comprehensive, interdisciplinary initiatives have been taken to examine the role of genetic variants on patient-reported quality-of-life outcomes. The overall objective of this paper is to describe the establishment of an international and interdisciplinary

  8. The establishment of the GENEQOL consortium to investigate the genetic disposition of patient-reported quality-of-life outcomes

    NARCIS (Netherlands)

    Sprangers, Mirjam A. G.; Sloan, Jeff A.; Veenhoven, Ruut; Cleeland, Charles S.; Halyard, Michele Y.; Abertnethy, Amy P.; Baas, Frank; Barsevick, Andrea M.; Bartels, Meike; Boomsma, Dorret I.; Chauhan, Cynthia; Dueck, Amylou C.; Frost, Marlene H.; Hall, Per; Klepstad, Pål; Martin, Nicholas G.; Miaskowski, Christine; Mosing, Miriam; Movsas, Benjamin; van Noorden, Cornelis J. F.; Patrick, Donald L.; Pedersen, Nancy L.; Ropka, Mary E.; Shi, Quiling; Shinozaki, Gen; Singh, Jasvinder A.; Yang, Ping; Zwinderman, Ailko H.

    2009-01-01

    To our knowledge, no comprehensive, interdisciplinary initiatives have been taken to examine the role of genetic variants on patient-reported quality-of-life outcomes. The overall objective of this paper is to describe the establishment of an international and interdisciplinary consortium, the

  9. The patient-physician partnership in asthma: real-world observations associated with clinical and patient-reported outcomes.

    Science.gov (United States)

    Small, M; Vickers, A; Anderson, P; Kay, S

    2010-09-01

    It is hypothesized that a good partnership between asthma patients and their physicians has a direct and positive influence on the patients' clinical and patient-reported outcomes. Conversely, poor partnership has a detrimental effect on clinical and patient-reported outcomes. This paper uses data from a real-world observational study to define partnership through matched physician and patient data and correlate the quality of partnership with observed clinical and patient-reported outcomes. Data were drawn from Adelphi's Respiratory Disease Specific Programme, a cross-sectional study of consulting patients in five European countries undertaken between June and September 2009. A range of clinical and patient-reported outcomes were observed allowing analysis of the partnership between 2251 asthma patients and their physicians. Analysis demonstrates that the better the partnership between patient and physician, the more likely the patient is to have their asthma condition controlled (PPartnership is also associated with lower impact on lifestyle (Ppartnership is a contributory factor in the improvement of asthma treatment, and patient education may lead to improvement in a patient's ability to contribute to this. Device satisfaction is one of the markers of good partnership.

  10. Patient-reported outcomes assessment in chronic hepatitis C treated with sofosbuvir and ribavirin: the VALENCE study

    NARCIS (Netherlands)

    Younossi, Zobair M.; Stepanova, Maria; Zeuzem, Stefan; Dusheiko, Geoffrey; Esteban, Rafael; Hezode, Christophe; Reesink, Hendrik W.; Weiland, Ola; Nader, Fatema; Hunt, Sharon L.

    2014-01-01

    Interferon (IFN) negatively impacts patients' well-being and patient-reported outcomes (PROs). Our aim was to assess PROs during treatment with an IFN-free regimen [sofosbuvir (SOF)+ribavirin (RBV)]. Four PRO questionnaires [Short Form-36 (SF-36), Chronic Liver Disease Questionnaire-HCV (CLDQ-HCV),

  11. Pregnancy and pregnancy outcome in hepatitis C type 1b.

    LENUS (Irish Health Repository)

    Jabeen, T

    2012-02-03

    A large cohort of rhesus-negative women in Ireland were inadvertently infected with hepatitis C virus following exposure to contaminated anti-D immunoglobulin in 1977-8. This major iatrogenic episode was discovered in 1994. We studied 36 women who had been infected after their first pregnancy, and compared them to an age- and parity-matched control group of rhesus-positive women. The presence of hepatitis C antibody was confirmed in all 36 by enzyme-linked immunosorbent assay and by recombinant immunoblot assay, while 26 (72%) of the cohort were HCV-RNA-positive (type 1b) on PCR testing. In the 20 years post-infection, all members of the study group had at least one pregnancy, and mean parity was 3.5. They had a total of 100 pregnancies and 85 of these went to term. There were four premature births, one being a twin pregnancy, and 11 spontaneous miscarriages. One miscarriage occurred in the pregnancy following HCV infection. There were two neonatal deaths due to severe congenital abnormalities in the PCR-positive women. Of the children born to HCV-RNA positive mothers, only one (2.3%) tested positive for the virus. Significant portal fibrosis on liver biopsy was confined to HCV-RNA-positive mothers apart from one single exception in the antibody-positive HCV-RNA-negative group. Comparison with the control group showed no increase in spontaneous miscarriage rate, and no significant difference in obstetric complications; birth weights were similar for the two groups.

  12. High-precision radiotherapy for meningiomas. Long-term results and patient-reported outcome (PRO)

    Energy Technology Data Exchange (ETDEWEB)

    Kessel, Kerstin A.; Fischer, Hanna; Combs, Stephanie E. [Technical University of Munich (TUM), Department of Radiation Oncology, Munich (Germany); Helmholtz Zentrum Muenchen (HMGU), Institute for Innovative Radiotherapy (iRT), Department of Radiation Sciences DRS, Neuherberg (Germany); Oechnser, Markus [Technical University of Munich (TUM), Department of Radiation Oncology, Munich (Germany); Zimmer, Claus [Technical University of Munich (TUM), Department of Neuroradiology, Munich (Germany); Meyer, Bernhard [Technical University of Munich (TUM), Department of Neurosurgery, Munich (Germany)

    2017-11-15

    To evaluate long-term outcome after high-precision radiotherapy (RT) of meningioma patients in terms of survival and side effects. We analyzed 275 meningioma cases: 147 low-grade and 43 high-grade meningiomas (WHO II: n = 40, III: n = 3). In all, 85 patients had no pathologically confirmed histology but were determined as low-grade based on multimodal imaging. Surgery was performed in 183 cases. RT was delivered as either radiosurgery (RS, n = 16), fractionated stereotactic radiotherapy (FSRT, n = 241), or intensity-modulated radiation therapy (IMRT, n = 18). Of 218 patients contacted for patient-reported-outcome (PRO), 207 responded (95%). Median follow-up was 7.2 years. For low-grade meningioma the survival rate (OS) was 97% at 3 years, 85% at 10 years, and 64% at 15 years, for atypical meningioma 91% at 3 years, 62% at 10 years, and 50% at 15 years. Local control rate (PFS) for low-grade meningioma was 91% at 3 years, 87% at 5 years, and 86% at 10 years, for atypical cases 67% at 3 years and 55% at 5 years. Of all, 3.0% of patients reported worsened or new symptoms grade ≥3 during RT and the first 6 months thereafter; 17.5% reported a deterioration after more than 2 years. We found the prognostic factors tumor volume and age significantly influencing OS and PFS. Complemented by PRO, we found long-term low toxicity rates in addition to excellent local control. Thus, due to the beneficial risk-benefit profile of benign and high-risk meningiomas, RT should be performed as adjuvant treatment and should not be postponed until tumor progression. (orig.) [German] Langzeitergebnisse nach Hochpraezisionsstrahlentherapie (RT) von Patienten mit Meningeomen hinsichtlich Ueberleben und Nebenwirkungen. Es wurden 275 Meningeomfaelle untersucht: 145 benigne (WHO I), 40 atypische (WHO II) und 3 anaplastische (WHO III) Meningeome; bei 85 Patienten bestand keine histologische Sicherung. Voroperiert waren 183 Faelle (67 %). Bei 16 Patienten wurde eine Radiochirurgie (RS

  13. Use of patient-reported outcomes in outpatient settings as a means of patient involvement and self-management support

    DEFF Research Database (Denmark)

    Mejdahl, Caroline; Nielsen, Berit Kjærside; Hjøllund, Niels Henrik Ingvar

    2016-01-01

    Rationale, aims and objectives: Patient-reported outcomes (PROs) are being implemented in clinical practice across different healthcare settings with varying purposes. Involving patients in reporting outcomes may increase their attention to symptoms and thereby support their self-management. The ...... to strengthen patient involvement and securing benefit from PROs.......Rationale, aims and objectives: Patient-reported outcomes (PROs) are being implemented in clinical practice across different healthcare settings with varying purposes. Involving patients in reporting outcomes may increase their attention to symptoms and thereby support their self......-management. The aim of the present study was to describe patients’ experiences with a web-based PRO system where patients complete a PRO questionnaire at home or in the outpatient clinic prior to a consultation. Moreover, the study aimed to explore how PROs influenced the interaction between patients and clinicians...

  14. A critical assessment of adverse pregnancy outcome and periodontal disease.

    Science.gov (United States)

    Wimmer, Gernot; Pihlstrom, Bruce L

    2008-09-01

    Pre-term birth is a major cause of infant mortality and morbidity that has considerable societal, medical, and economic costs. The rate of pre-term birth appears to be increasing world-wide and efforts to prevent or reduce its prevalence have been largely unsuccessful. To review the literature for studies investigating periodontal disease as a possible risk factor for pre-term birth and adverse pregnancy outcomes. Variability among studies in definitions of periodontal disease and adverse pregnancy outcomes as well as widespread inadequate control for confounding factors and possible effect modification make it difficult to base meaningful conclusions on published data. However, while there are indications of an association between periodontal disease and increased risk of adverse pregnancy outcome in some populations, there is no conclusive evidence that treating periodontal disease improves birth outcome. Based on a critical qualitative review, available evidence from clinical trials indicates that, although non-surgical mechanical periodontal treatment in the second trimester of pregnancy is safe and effective in reducing signs of maternal periodontal disease, it does not reduce the rate of pre-term birth. Clinical trials currently underway will further clarify the potential role of periodontal therapy in preventing adverse birth outcomes. Regardless of the outcomes of these trials, it is recommended that large, prospective cohort studies be conducted to assess risk for adverse pregnancy outcome in populations with periodontal disease. It is critical that periodontal exposure and adverse birth outcomes be clearly defined and the many potential confounding factors and possible effect modifiers for adverse pregnancy outcome be controlled in these studies. If periodontal disease is associated with higher risk of adverse pregnancy outcome in these specific populations, large multicenter randomized-controlled trials will be needed to determine if prevention or

  15. Impact of daily number of urgency urinary incontinence episodes on overactive bladder patient reported outcomes.

    Science.gov (United States)

    Angulo, J C; Brenes, F J; Lizarraga, I; Rejas, J; Trillo, S; Ochayta, D; Arumi, D

    2016-04-01

    To explore the impact of urgency urinary incontinence (UUI) on well-being in non-institutionalized patients with overactive bladder (OAB) in a community sample. A cross-sectional web-based study was conducted in the general population, including males and females, >18 years of age. Patients with probable OAB were identified using a validated algorithm together with a score ≥8 on the OAB-V8 scale. Presence of coping behavior was considered determinant for the clinical diagnosis of OAB. Individual well-being was determined through a battery of patient-reported outcomes (PRO) measurements including assessment of health-related quality of life (EQ-5D), sleep disturbances (MOS Sleep), and life satisfaction (LISAT-8). Patients were grouped according to the number of daily UUI episodes (UUI severity): 0 (dry OAB),1, 2-3, or ≥4. Multivariate analysis to evaluate factors independently affecting quality of life was undertaken. A total of 396 patients (52.5% women, mean age: 55.3 [11.1] years, OAB-V8 mean score: 14.5 [7.9]) out of 2035 subjects participating from the general population met the criteria for OAB: 203 (51.3%) with 0episodes, 119 (30.1%) with 1, 52 (13.1%) with 2 or 3, and 22 (5.6%) with ≥4 episodes. A statistically significant linear adjusted association was found between number of UUI episodes and PRO scores. Participants with more episodes had poorer health profiles and self-evaluated quality of life, worse life satisfaction, and more sleep disturbances and fewer hours of sleep per night. Number of incontinence episodes was independent factor to affect quality of life using both LISAT-8 and MOS questionnaires. Severity of UUI was significantly associated with poorer individual well-being in subjects with OAB in a community sample in Spain. Copyright © 2015 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

  16. Validation study of the Forgotten Joint Score-12 as a universal patient-reported outcome measure.

    Science.gov (United States)

    Matsumoto, Mikio; Baba, Tomonori; Homma, Yasuhiro; Kobayashi, Hideo; Ochi, Hironori; Yuasa, Takahito; Behrend, Henrik; Kaneko, Kazuo

    2015-10-01

    The Forgotten Joint Score-12 (FJS-12) is for patients to forget their artificial joint and is reportedly a useful patient-reported outcome tool for artificial joints. The purpose of this study was to determine whether the FJS-12 is as useful as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) or the Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire (JHEQ) in Japan. All patients who visited our hospital's hip joint specialists following unilateral THA from August 2013 to July 2014 were evaluated. Medical staff members other than physicians administered three questionnaires. Items evaluated were (1) the reliability of the FJS-12 and (2) correlations between the FJS-12 and the total and subscale scores of the WOMAC or JHEQ. Of 130 patients, 22 were excluded. Cronbach's α coefficient was 0.97 for the FJS-12. The FJS-12 showed a significantly lower score than the WOMAC or JHEQ (p < 0.01). The FJS-12 was moderately correlated with the total WOMAC score (r = 0.522) and its subscale scores for "stiffness" (r = 0.401) and "function" (r = 0.539) and was weakly correlated with the score for "pain" (r = 0.289). The FJS-12 was favorably correlated with the total JHEQ score (r = 0.686) and its subscale scores (r = 0.530-0.643). The FJS-12 was correlated with and showed reliability similar to that of the JHEQ and WOMAC. The FJS-12, which is not affected by culture or lifestyle, may be useful in Japan.

  17. Patient-Reported Outcome (PRO) Consortium translation process: consensus development of updated best practices.

    Science.gov (United States)

    Eremenco, Sonya; Pease, Sheryl; Mann, Sarah; Berry, Pamela

    2017-01-01

    This paper describes the rationale and goals of the Patient-Reported Outcome (PRO) Consortium's instrument translation process. The PRO Consortium has developed a number of novel PRO measures which are in the process of qualification by the U.S. Food and Drug Administration (FDA) for use in clinical trials where endpoints based on these measures would support product labeling claims. Given the importance of FDA qualification of these measures, the PRO Consortium's Process Subcommittee determined that a detailed linguistic validation (LV) process was necessary to ensure that all translations of Consortium-developed PRO measures are performed using a standardized approach with the rigor required to meet regulatory and pharmaceutical industry expectations, as well as having a clearly defined instrument translation process that the translation industry can support. The consensus process involved gathering information about current best practices from 13 translation companies with expertise in LV, consolidating the findings to generate a proposed process, and obtaining iterative feedback from the translation companies and PRO Consortium member firms on the proposed process in two rounds of review in order to update existing principles of good practice in LV and to provide sufficient detail for the translation process to ensure consistency across PRO Consortium measures, sponsors, and translation companies. The consensus development resulted in a 12-step process that outlines universal and country-specific new translation approaches, as well as country-specific adaptations of existing translations. The PRO Consortium translation process will play an important role in maintaining the validity of the data generated through these measures by ensuring that they are translated by qualified linguists following a standardized and rigorous process that reflects best practice.

  18. The Content Validity of a Chemotherapy-Induced Peripheral Neuropathy Patient-Reported Outcome Measure

    Science.gov (United States)

    Lavoie Smith, Ellen M.; Haupt, Rylie; Kelly, James P.; Lee, Deborah; Kanzawa-Lee, Grace; Knoerl, Robert; Bridges, Celia; Alberti, Paola; Prasertsri, Nusara; Donohoe, Clare

    2018-01-01

    Purpose/Objectives To test the content validity of a 16-item version of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire–Chemotherapy-Induced Peripheral Neuropathy (QLQ-CIPN20). Research Approach Cross-sectional, prospective, qualitative design. Setting Six outpatient oncology clinics within the University of Michigan Health System’s comprehensive cancer center in Ann Arbor. Participants 25 adults with multiple myeloma or breast, gynecologic, gastrointestinal, or head and neck malignancies experiencing peripheral neuropathy caused by neurotoxic chemotherapy. Methodologic Approach Cognitive interviewing methodology was used to evaluate the content validity of a 16-item version of the QLQ-CIPN20 instrument. Findings Minor changes were made to three questions to enhance readability. Twelve questions were revised to define unfamiliar terminology, clarify the location of neuropathy, and emphasize important aspects. One question was deleted because of clinical and conceptual redundancy with other items, as well as concerns regarding generalizability and social desirability. Interpretation Cognitive interviewing methodology revealed inconsistencies between patients’ understanding and researchers’ intent, along with points that required clarification to avoid misunderstanding. Implications for Nursing Patients’ interpretations of the instrument’s items were inconsistent with the intended meanings of the questions. One item was dropped and others were revised, resulting in greater consistency in how patients, clinicians, and researchers interpreted the items’ meanings and improving the instrument’s content validity. Following additional revision and psychometric testing, the QLQ-CIPN20 could evolve into a gold-standard CIPN patient-reported outcome measure. PMID:28820525

  19. 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.

  20. 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.

  1. [Development of patient-reported outcome scale for myasthenia gravis: a psychometric test].

    Science.gov (United States)

    Chen, Xin-lin; Liu, Feng-bin; Guo, Li; Liu, Xiao-bin

    2010-02-01

    To investigate the scientificity of patient-reported outcome (PRO) scale for myasthenia gravis (MG), which was used to evaluate the clinical effects of traditional Chinese and Western medicine treatment on MG patients. Psychometric performance of the MG-PRO scale was also expected to be evaluated in this study. A total of 100 MG patients and 100 healthy people were face-to-face interviewed by well-trained investigators, and the data of MG-PRO scale were collected. The classical theory test (CTT) and item response theory (IRT) methods were used to analyze the psychometric performance such as validity, reliability, person separation index (PSI) and differential item functioning (DIF) in the MG-PRO scale. The results of CTT analysis showed that the split-half reliabilities of the MG-PRO scale and each dimension were greater than 0.7. In the analysis of internal consistency of each dimension, the Cronbach's alpha was greater than 0.8. Each facet had greater correlation with its dimension than the other dimensions. Four principal components were extracted by exploratory factor analysis, which represented all dimensions of the scale, and the cumulative variance was 55.54%. The scores of each of the 8 facets between MG patients and healthy people were different (Pdefinition and connotation of quality of life and contains special issues of MG patients as well, and shows good reliability (split-half reliability, Cronbach's alpha), validity (content validity, construct validity, discriminate validity) from the results of CTT, and good psychometric performance from the results of IRT.

  2. Disease burden and patient reported outcomes among patients with moderate to severe psoriasis: an ethnography study

    Directory of Open Access Journals (Sweden)

    Narayanan S

    2014-12-01

    Full Text Available Siva Narayanan,1 Victoria Guyatt,2 Alessandra Franceschetti,3 Emily L Hautamaki1 1Ipsos Healthcare, Columbia, MD, USA; 2Ipsos Ethnography Centre of Excellence (ECE, London, UK; 3Ipsos Healthcare, London, UK Objectives: To assess the impact of psoriasis on health-related quality of life (HRQoL.Methods: An ethnographic study of patients with moderate to severe psoriasis was conducted in the US, France, Germany, Italy, Spain, UK, Brazil, and Canada to explore patients' views on treatment and the impact of psoriasis on HRQoL. Anthropologists and ethnographers spent a minimum of 5.5 hours with each consented patient and filmed their behaviors in everyday situations. Visual data and notes were analyzed to identify HRQoL-related themes.Results: The study included 50 adult patients. Patients described their appearance with disgust and self-loathing. Frustration was expressed due to a perceived lack of control of their lives. Prior to initiation of biologic treatment, daily rituals absorbed a good part of their day, including applying creams, checking one's appearance, and covering the body. Due to a lack of cultural discourse and patient's difficulty in articulating the impact of psoriasis, partners and family did not know how to react nor did they realize the full extent of the problem, and many patients experienced perceived social discrimination due to psoriasis, leaving them with feelings of isolation. Patients established on biologic treatment noticed a significant physical improvement and regained confidence, but psychosocial impacts, including social isolation, remained.Conclusion: This ethnographic study vividly depicted the unarticulated and emotional impact of psoriasis on the everyday lives of patients and presents an effective method of assessing HRQoL in chronic diseases.Keywords: psoriasis, health-related quality of life, ethnography, patient reported outcomes, conceptual model

  3. Reliability of patient-reported outcomes in rheumatoid arthritis patients: an observational prospective study.

    Science.gov (United States)

    Studenic, Paul; Stamm, Tanja; Smolen, Josef S; Aletaha, Daniel

    2016-01-01

    Patient-reported outcomes (PROs) such as pain, patient global assessment (PGA) and fatigue are regularly assessed in RA patients. In the present study, we aimed to explore the reliability and smallest detectable differences (SDDs) of these PROs, and whether the time between assessments has an impact on reliability. Forty RA patients on stable treatment reported the three PROs daily over two subsequent months. We assessed the reliability of these measures by calculating intraclass correlation coefficients (ICCs) and the SDDs for 1-, 7-, 14- and 28-day test-retest intervals. Overall, SDD and ICC were 25 mm and 0.67 for pain, 25 mm and 0.71 for PGA and 30 mm and 0.66 for fatigue, respectively. SDD was higher with longer time period between assessments, ranging from 19 mm (1-day intervals) to 30 mm (28-day intervals) for pain, 19 to 33 mm for PGA, and 26 to 34 mm for fatigue; correspondingly, ICC was smaller with longer intervals, and ranged between the 1- and the 28-day interval from 0.80 to 0.50 for pain, 0.83 to 0.57 for PGA and 0.76 to 0.58 for fatigue. The baseline simplified disease activity index did not have any influence on reliability. Lower baseline PRO scores led to smaller SDDs. Reliability of pain, PGA and fatigue measurements is dependent on the tested time interval and the baseline levels. The relatively high SDDs, even for patients in the lowest tertiles of their PROs, indicate potential issues for assessment of the presence of remission. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  4. Comparative effectiveness studies examining patient-reported outcomes among children with cleft lip and/or palate: a systematic review.

    Science.gov (United States)

    Ranganathan, Kavitha; Vercler, Christian J; Warschausky, Seth A; MacEachern, Mark P; Buchman, Steven R; Waljee, Jennifer F

    2015-01-01

    Health care policy makers are increasingly encouraging comparative effectiveness research. Little is known regarding comparative studies among children with cleft lip and/or palate. Cleft lip and/or palate profoundly influences self-perception and social functioning, and patient-reported outcomes provide a unique perspective on the success of reconstruction. The purpose of this study was to systematically review the literature regarding patient-reported outcomes among patients with cleft lip and/or palate. The authors reviewed articles from MEDLINE, Embase, and PsycInfo that examined the use of patient-reported outcome instruments for cleft lip and/or palate. Studies of patients with cleft lip and/or palate across any age that described the use of patient-completed measures in patient and control populations were included. A research librarian confirmed the search, and two independent, blinded reviewers performed full-text review. The authors identified 1979 articles and selected 30 for inclusion. Forty-two different assessment tools were used to analyze factors such as self-esteem, behavior, and social support. The Strengths and Difficulties Questionnaire was most commonly used (n = 7), followed by the Childhood Experience Questionnaire (n = 5), and the Satisfaction with Appearance survey (n = 4). Barriers to analysis included lack of standardization of survey administration, effect of publication bias, and variations in patient populations between individual studies. Comparative studies of patient-reported outcomes among patients with cleft lip and/or palate are infrequent. Many instruments exist to measure patient-reported outcomes in this population, but no specific standard exists. Identifying efficient and targeted forms of instrument selection and administration will enhance comparative studies among children with cleft lip and/or palate. Diagnostic, III.

  5. Self-efficacy as a predictor of patient-reported outcomes in adults with congenital heart disease.

    Science.gov (United States)

    Thomet, Corina; Moons, Philip; Schwerzmann, Markus; Apers, Silke; Luyckx, Koen; Oechslin, Erwin N; Kovacs, Adrienne H

    2018-04-01

    Self-efficacy is a known predictor of patient-reported outcomes in individuals with acquired diseases. With an overall objective of better understanding patient-reported outcomes in adults with congenital heart disease, this study aimed to: (i) assess self-efficacy in adults with congenital heart disease, (ii) explore potential demographic and medical correlates of self-efficacy and (iii) determine whether self-efficacy explains additional variance in patient-reported outcomes above and beyond known predictors. As part of a large cross-sectional international multi-site study (APPROACH-IS), we enrolled 454 adults (median age 32 years, range: 18-81) with congenital heart disease in two tertiary care centres in Canada and Switzerland. Self-efficacy was measured using the General Self-Efficacy (GSE) scale, which produces a total score ranging from 10 to 40. Variance in the following patient-reported outcomes was assessed: perceived health status, psychological functioning, health behaviours and quality of life. Hierarchical multivariable linear regression analysis was performed. Patients' mean GSE score was 30.1 ± 3.3 (range: 10-40). Lower GSE was associated with female sex ( p = 0.025), not having a job ( p = 0.001) and poorer functional class ( p = 0.048). GSE positively predicted health status and quality of life, and negatively predicted symptoms of anxiety and depression, with an additional explained variance up to 13.6%. No associations between self-efficacy and health behaviours were found. GSE adds considerably to our understanding of patient-reported outcomes in adults with congenital heart disease. Given that self-efficacy is a modifiable psychosocial factor, it may be an important focus for interventions targeting congenital heart disease patients' well-being.

  6. Cluster analysis as a prediction tool for pregnancy outcomes.

    Science.gov (United States)

    Banjari, Ines; Kenjerić, Daniela; Šolić, Krešimir; Mandić, Milena L

    2015-03-01

    Considering specific physiology changes during gestation and thinking of pregnancy as a "critical window", classification of pregnant women at early pregnancy can be considered as crucial. The paper demonstrates the use of a method based on an approach from intelligent data mining, cluster analysis. Cluster analysis method is a statistical method which makes possible to group individuals based on sets of identifying variables. The method was chosen in order to determine possibility for classification of pregnant women at early pregnancy to analyze unknown correlations between different variables so that the certain outcomes could be predicted. 222 pregnant women from two general obstetric offices' were recruited. The main orient was set on characteristics of these pregnant women: their age, pre-pregnancy body mass index (BMI) and haemoglobin value. Cluster analysis gained a 94.1% classification accuracy rate with three branch- es or groups of pregnant women showing statistically significant correlations with pregnancy outcomes. The results are showing that pregnant women both of older age and higher pre-pregnancy BMI have a significantly higher incidence of delivering baby of higher birth weight but they gain significantly less weight during pregnancy. Their babies are also longer, and these women have significantly higher probability for complications during pregnancy (gestosis) and higher probability of induced or caesarean delivery. We can conclude that the cluster analysis method can appropriately classify pregnant women at early pregnancy to predict certain outcomes.

  7. Interpreting patient-reported outcomes from clinical trials in COPD: a discussion

    Directory of Open Access Journals (Sweden)

    Jones PW

    2016-12-01

    Full Text Available Paul W Jones,1,2 Stephen Rennard,3,4 Maggie Tabberer,5 John H Riley,2 Mitra Vahdati-Bolouri,2 Neil C Barnes2,6 1Institute for Infection and Immunity, University of London, London, 2Global Respiratory Franchise, GlaxoSmithKline, Uxbridge, UK; 3Division of Pulmonary, Critical Care, Sleep and Allergy, Nebraska Medical Center, Omaha, NE, USA; 4Clinical Discovery Unit, AstraZeneca, Cambridge, 5Global R&D, GlaxoSmithKline, Uxbridge, 6William Harvey Institute, Bart’s and the London School of Medicine and Dentistry, London, UK Abstract: One of the challenges faced by the practising physician is the interpretation of patient-reported outcomes (PROs in clinical trials and the relevance of such data to their patients. This is especially true when caring for patients with progressive diseases such as COPD. In an attempt to incorporate the patient perspective, many clinical trials now include assessments of PROs. These are formalized methods of capturing patient-centered information. Given the importance of PROs in evaluating the potential utility of an intervention for a patient with COPD, it is important that physicians are able to critically interpret (and critique the results derived from them. Therefore, in this paper, a series of questions is posed for the practising physician to consider when reviewing the treatment effectiveness as assessed by PROs. The focus is on the St George’s Respiratory Questionnaire for worked examples, but the principles apply equally to other symptom-based questionnaires. A number of different ways of presenting PRO data are discussed, including the concept of the minimum clinically important difference, whether there is a ceiling effect to PRO results, and the strengths and weaknesses of responder analyses. Using a worked example, the value of including a placebo arm in a study is illustrated, and the influence of the study on PRO results is considered, in terms of the design, patient withdrawal, and the selection of

  8. Adjunctive naturopathic care for type 2 diabetes: patient-reported and clinical outcomes after one year

    Directory of Open Access Journals (Sweden)

    Bradley Ryan

    2012-04-01

    Full Text Available Abstract Background Several small, uncontrolled studies have found improvements in self-care behaviors and reductions in clinical risk in persons with type 2 diabetes who received care from licensed naturopathic physicians. To extend these findings and determine the feasibility and promise of a randomized clinical trial, we conducted a prospective study to measure the effects of adjunctive naturopathic care (ANC in primary care patients with inadequately controlled type 2 diabetes. Methods Forty patients with type 2 diabetes were invited from a large integrated health care system to receive up to eight ANC visits for up to one year. Participants were required to have hemoglobin A1c (HbA1c values between 7.5-9.5 % and at least one additional cardiovascular risk factor (i.e., hypertension, hyperlipidemia or overweight. Standardized instruments were administered by telephone to collect outcome data on self-care, self-efficacy, diabetes problem areas, perceived stress, motivation, and mood. Changes from baseline scores were calculated at 6- and 12-months after entry into the study. Six and 12-month changes in clinical risk factors (i.e., HbA1c, lipid and blood pressure were calculated for the ANC cohort, and compared to changes in a cohort of 329 eligible, non-participating patients constructed using electronic medical records data. Between-cohort comparisons were adjusted for age, gender, baseline HbA1c, and diabetes medications. Six months was pre-specified as the primary endpoint for outcome assessment. Results Participants made 3.9 ANC visits on average during the year, 78 % of which occurred within six months of entry into the study. At 6-months, significant improvements were found in most patient-reported measures, including glucose testing (P = 0.001, diet (P = 0.001, physical activity (P = 0.02, mood (P = 0.001, self-efficacy (P = 0.0001 and motivation to change lifestyle (P = 0.003. Improvements in glucose testing, mood, self-efficacy and

  9. Non-dystrophic myotonia: prospective study of objective and patient reported outcomes.

    Science.gov (United States)

    Trivedi, Jaya R; Bundy, Brian; Statland, Jeffrey; Salajegheh, Mohammad; Rayan, Dipa Raja; Venance, Shannon L; Wang, Yunxia; Fialho, Doreen; Matthews, Emma; Cleland, James; Gorham, Nina; Herbelin, Laura; Cannon, Stephen; Amato, Anthony; Griggs, Robert C; Hanna, Michael G; Barohn, Richard J

    2013-07-01

    .6% of sodium channel participants, which increased post-cooling to 57.6% in sodium channel mutations. In evaluation of patients with clinical and electrical myotonia, despite considerable phenotypic overlap, the presence of eye closure myotonia, paradoxical myotonia, and an increase in short exercise test sensitivity post-cooling suggest sodium channel mutations. Outcomes designed to measure stiffness or the electrophysiological correlates of stiffness may prove useful for future clinical trials, regardless of underlying mutation, and include patient-reported stiffness, bedside manoeuvres to evaluate myotonia, muscle specific quality of life instruments and short exercise testing.

  10. Training clinicians in how to use patient-reported outcome measures in routine clinical practice.

    Science.gov (United States)

    Santana, Maria J; Haverman, Lotte; Absolom, Kate; Takeuchi, Elena; Feeny, David; Grootenhuis, Martha; Velikova, Galina

    2015-07-01

    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 data. However, as the experience in using those measures increased, it became obvious the clinical value in using individual patient PROs profiles in daily practice to identify/monitor symptoms, evaluate treatment outcomes and support shared decision-making. A key issue limiting successful implementation is clinicians' lack of knowledge on how to effectively utilize PROs data in their clinical encounters. Using a change management theoretical framework, this paper describes the development and implementation of three programs for training clinicians to effectively use PRO data in routine practice. The training programs are in three diverse clinical areas (adult oncology, lung transplant and paediatrics), in three countries with different healthcare systems, thus providing a rare opportunity to pull out common approaches whilst recognizing specific settings. For each program, we describe the clinical and organizational setting, the program planning and development, the content of the training session with supporting material, subsequent monitoring of PROs use and evidence of adoption. The common successful components and practical steps are identified, leading to discussion and future recommendations. The results of the three training programs are described as the implementation. In the oncology program, PRO data have been developed and are currently evaluated; in the lung transplant program, PRO data are used in daily practice and the integration with electronic patient records is under development; and in the paediatric program, PRO data are fully implemented with around 7,600 consultations since the start of the implementation. Adult learning programs teaching clinicians

  11. PRISM, a Patient-Reported Outcome Instrument, Accurately Measures Symptom Change in Refractory Gastroesophageal Reflux Disease.

    Science.gov (United States)

    Fuller, Garth; Bolus, Roger; Whitman, Cynthia; Talley, Jennifer; Erder, M Haim; Joseph, Alain; Silberg, Debra G; Spiegel, Brennan

    2017-03-01

    Most patients with gastroesophageal reflux disease (GERD) experience relief following treatment with proton pump inhibitors (PPIs) (Vakil et al. in Am J Gastroenterol 101:1900-1920, 2006; Everhart and Ruhl in Gastroenterology 136:376-386, 2009). As many as 17-44% of patients, however, exhibit only partial response to therapy. Most extant GERD patient-reported outcome (PRO) instruments fail to meet development best practices as described by the FDA (Talley and Wiklund in Qual Life Res 14:21-33, 2005; Van Pinxteren et al. in Cochrane Database Syst Rev 18:CD002095, 2004; El-Serag et al. in Aliment Pharmacol Ther 32:720-737, 2010). To develop and validate a PRO instrument for clinical trials involving patients with GERD who are PPI partial responders. We prepared a systematic literature review, held patient focus groups, convened an expert panel, and conducted cognitive interviews to establish content validity. Eligible participants took PPI therapy for at least 8 weeks, had undergone an upper endoscopy, and scored at least 8 points on the GerdQ [6]. Qualitative data guided development of 26 draft items. Items were reviewed by expert panels and debriefed with patients. The resulting 21-item instrument underwent psychometric evaluation during a Phase IIB trial. During the trial, confirmatory factor analysis (n = 220) resulted in a four-factor model displaying the highest goodness of fit. All domains had a high inter-item correlation (Cronbach's α > 0.8). Test-retest reliability and convergent validity were strong, with highly significant (p < 0.01) correlations between average weekly PRISM scores and severity anchors and significant (p < 0.05) correlations with anchor subscales. Cumulative distribution functions revealed significant differences between responders and non-responders. Analysis in a clinical trial setting demonstrated strong psychometric properties suggesting validity of PRISM. Developed in line with FDA guidance on PROs, PRISM represents an

  12. Pregnancy incidence and outcomes in women with perinatal HIV infection.

    Science.gov (United States)

    Byrne, Laura; Sconza, Rebecca; Foster, Caroline; Tookey, Pat A; Cortina-Borja, Mario; Thorne, Claire

    2017-07-31

    To estimate the incidence of first pregnancy in women living with perinatally acquired HIV (PHIV) in the United Kingdom and to compare pregnancy management and outcomes with age-matched women with behaviourally acquired HIV (BHIV). The National Study of HIV in Pregnancy and Childhood is a comprehensive, population-based surveillance study that collects demographic and clinical data on all pregnant women living with HIV, their children, and all HIV-infected children in the United Kingdom and Ireland. The incident rate ratio of first pregnancy was calculated for all women of reproductive age who had been reported to the National Study of HIV in Pregnancy and Childhood as vertically infected children. These women and their pregnancies were compared to age-matched pregnant women with BHIV. Of the 630 women with PHIV reported in the United Kingdom as children, 7% (45) went on to have at least one pregnancy, with 70 pregnancies reported. The incident rate ratio of first pregnancy was 13/1000 woman-years. The BHIV comparison group comprised 118 women (184 pregnancies). Women with PHIV were more likely to be on combined antiretroviral therapy at conception and have a lower baseline CD4 cell count (P pregnancy incidence, but those who become pregnant are at risk of detectable viral load near delivery, reflecting their often complex clinical history, adherence, and drug resistance issues.

  13. Incident pregnancy and pregnancy outcomes among HIV-infected women in Uganda and Zimbabwe.

    Science.gov (United States)

    Lancaster, Kathryn E; Kwok, Cynthia; Rinaldi, Anne; Byamugisha, Josaphat; Magwali, Tulani; Nyamapfeni, Prisca; Salata, Robert A; Morrison, Charles S

    2015-12-01

    To describe pregnancy outcomes among HIV-infected women and examine factors associated with live birth among those receiving and not receiving combination antiretroviral therapy (cART). The present analysis included women with HIV from Uganda and Zimbabwe who participated in a prospective cohort study during 2001-2009. Incident pregnancies and pregnancy outcomes were recorded quarterly. The Kaplan-Meier method was used to estimate incident pregnancy probabilities; factors associated with live birth were evaluated by Poisson regression with generalized estimating equations. Among 306 HIV-infected women, there were 160 incident pregnancies (10.1 per 100 women-years). The pregnancy rate was higher among cART-naïve women than among those receiving cART (10.7 vs 5.5 per 100 women-years; P=0.047), and it was higher in Uganda than in Zimbabwe (14.4 vs 7.7 per 100 women-years; Ppregnancy (relative risk 0.8; 95% confidence interval 0.7-1.0). Women not receiving cART have higher pregnancy rates than do those receiving cART, but cART use might not affect the risk of adverse pregnancy outcomes. Timely prenatal care and monitoring of illnesses during pregnancy should be incorporated into treatment services for HIV-infected women. Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

  14. Provincial development of a patient-reported outcome initiative to guide patient care, quality improvement, and research.

    Science.gov (United States)

    Olson, Robert A; Howard, Fuchsia; Lapointe, Vincent; Schellenberg, Devin; Nichol, Alan; Bowering, Gale; Curtis, Susan; Walter, Allison; Brown, Steven; Thompson, Corinne; Bergin, Jackie; Lomas, Sheri; French, John; Halperin, Ross; Tyldesley, Scott; Beckham, Wayne

    2018-01-01

    The BC Cancer Agency Radiotherapy (RT) program started the Prospective Outcomes and Support Initiative (POSI) at all six centres to utilize patient-reported outcomes for immediate clinical care, quality improvement, and research. Patient-reported outcomes were collected at time of computed tomography simulation via tablet and 2 to 4 weeks post-RT via either tablet or over the phone by a registered nurse. From 2013 to 2016, patients were approached on 20,150 attempts by POSI for patients treated with RT for bone metastases (52%), brain metastases (11%), lung cancer (17%), gynecological cancer (16%), head and neck cancer (2%), and other pilots (2%). The accrual rate for all encounters was 85% (n = 17,101), with the accrual rate varying between the lowest and the highest accruing centre from 78% to 89% ( P < .001) and varying by tumour site ( P < .001). Using the POSI database, we have performed research and quality improvement initiatives that have changed practice.

  15. Pregnancy Outcomes in Booked HIV Positive Women Initiating ...

    African Journals Online (AJOL)

    Saharan Africa which bears the highest burden of the disease. To evaluate pregnancy outcomes in booked preg-nant women on Highly Active Antiretroviral Therapy (HAART) at the University of Ilorin Teach-ing Hospital (UITH), Ilorin, Nigeria; ...

  16. ADVERSE PREGNANCY OUTCOMES ASSOCIATED WITH MATERNAL ENALAPRIL ANTIHYPERTENSIVE TREATMENT

    Science.gov (United States)

    Enalapril, one of several antihypertensive drugs that act as angiotensin-converting enzyme (ACE) inhibitors, is often used for treatment of hypertension in women of reproductive age. Adverse birth outcomes following the use of ACE inhibitors, including enalapril, during pregnanc...

  17. Knowledge of outcome of pregnancy and labour among rural ...

    African Journals Online (AJOL)

    Knowledge of outcome of pregnancy and labour among rural pregnant ... and poverty for the teen mother and the child, and has serious consequences for society. ... little or no time for appropriate screening and management of risk factors.

  18. Antenatal care and pregnancy outcome in Ghana, the importance of ...

    African Journals Online (AJOL)

    Antenatal care and pregnancy outcome in Ghana, the importance of women\\'s ... The antenatal characteristics of 503 pregnant women attending maternal and child ... Higher educational level associated with early antenatal care attendance.

  19. A systematic review and development of a classification framework for factors associated with missing patient-reported outcome data.

    Science.gov (United States)

    Palmer, Michael J; Mercieca-Bebber, Rebecca; King, Madeleine; Calvert, Melanie; Richardson, Harriet; Brundage, Michael

    2018-02-01

    Missing patient-reported outcome data can lead to biased results, to loss of power to detect between-treatment differences, and to research waste. Awareness of factors may help researchers reduce missing patient-reported outcome data through study design and trial processes. The aim was to construct a Classification Framework of factors associated with missing patient-reported outcome data in the context of comparative studies. The first step in this process was informed by a systematic review. Two databases (MEDLINE and CINAHL) were searched from inception to March 2015 for English articles. Inclusion criteria were (a) relevant to patient-reported outcomes, (b) discussed missing data or compliance in prospective medical studies, and (c) examined predictors or causes of missing data, including reasons identified in actual trial datasets and reported on cover sheets. Two reviewers independently screened titles and abstracts. Discrepancies were discussed with the research team prior to finalizing the list of eligible papers. In completing the systematic review, four particular challenges to synthesizing the extracted information were identified. To address these challenges, operational principles were established by consensus to guide the development of the Classification Framework. A total of 6027 records were screened. In all, 100 papers were eligible and included in the review. Of these, 57% focused on cancer, 23% did not specify disease, and 20% reported for patients with a variety of non-cancer conditions. In total, 40% of the papers offered a descriptive analysis of possible factors associated with missing data, but some papers used other methods. In total, 663 excerpts of text (units), each describing a factor associated with missing patient-reported outcome data, were extracted verbatim. Redundant units were identified and sequestered. Similar units were grouped, and an iterative process of consensus among the investigators was used to reduce these units to a

  20. Teen Pregnancy : Are Pregnancies following an Elective Termination Associated with Increased Risk for Adverse Perinatal Outcomes?

    NARCIS (Netherlands)

    van Veen, Teelkien R.; Haeri, Sina; Baker, Arthur M.

    2015-01-01

    Study Objective: The authors sought to determine whether pregnancies in adolescents following an abortion of pregnancy is associated with an elevated risk for adverse perinatal outcomes. Methods: In a cohort study of all adolescent (younger than 18 years) deliveries over a 4-year period at 1

  1. The outcome of pregnancy after threatened abortion.

    Science.gov (United States)

    Hertz, J B; Heisterberg, L

    1985-01-01

    A prospectively collected group of 93 pregnancies complicated by threatened abortion was carefully monitored throughout pregnancy, during birth and in the perinatal period, and any deviation from a completely uneventful course was registered. Comparison was made with a selected group of 282 non-risk pregnant women. A significant association was found between threatened abortion and the overall number of complications in the second half of pregnancy requiring medical intervention and/or admission to hospital, impending pre-term birth requiring betamimetics, pre-term birth, retention of the placenta, birth weight below 2000 g, light-for-dates infants in case of pre-term birth or birth weight below 2000 g, and hyperbilirubinemia in infants with birth weight below 2000 g. The incidences of perinatal mortality and congenital malformations did not differ significantly from those of the control group. Pregnancies complicated by threatened abortion constitute a risk group requiring careful obstetric and perinatal supervision and follow-up.

  2. Patient-Reported Outcome Measures in Dysphagia: A Systematic Review of Instrument Development and Validation

    Science.gov (United States)

    Patel, Dhyanesh A.; Sharda, Rohit; Hovis, Kristen L.; Nichols, Erin E.; Sathe, Nila; Penson, David F.; Feurer, Irene D.; McPheeters, Melissa L.; Vaezi, Michael F.; Francis, David O.

    2017-01-01

    Objective Patient-reported outcome (PRO) measures are commonly used to capture patient experience with dysphagia and to evaluate treatment effectiveness. Inappropriate application can lead to distorted results in clinical studies. A systematic review of the literature on dysphagia-related PRO measures was performed to 1) identify all currently available measures and 2) to evaluate each for the presence of important measurement properties that would affect their applicability. Design MEDLINE via the PubMed interface, the Cumulative Index of Nursing and Allied Health Literature, and the Health and Psychosocial Instrument database were searched using relevant vocabulary terms and key terms related to PRO measures and dysphagia. Three independent investigators performed abstract and full text reviews. Each study meeting criteria was evaluated using an 18-item checklist developed a priori that assessed multiple domains: 1) conceptual model, 2) content validity, 3) reliability, 4) construct validity, 6) scoring and interpretation, and 7) burden and presentation. Results Of 4950 abstracts reviewed, a total of 34 dysphagia-related PRO measures (publication year 1987 – 2014) met criteria for extraction and analysis. Several PRO measures were of high quality (MADS for achalasia, SWAL-QOL and SSQ for oropharyngeal dysphagia, PROMIS-GI for general dysphagia, EORTC-QLQ-OG25 for esophageal cancer, ROMP-swallowing for Parkinson’s disease, DSQ-EoE for eosinophilic esophagitis, and SOAL for total laryngectomy-related dysphagia). In all, 17 met at least one criterion per domain. Thematic deficiencies in current measures were evident including: 1) direct patient involvement in content development, 2) empirically justified dimensionality, 3) demonstrable responsiveness to change, 4) plan for interpreting missing responses, and 5) literacy level assessment. Conclusion This is the first comprehensive systematic review assessing developmental properties of all available dysphagia

  3. Communicating patient-reported outcome scores using graphic formats: results from a mixed-methods evaluation.

    Science.gov (United States)

    Brundage, Michael D; Smith, Katherine C; Little, Emily A; Bantug, Elissa T; Snyder, Claire F

    2015-10-01

    Patient-reported outcomes (PROs) promote patient-centered care by using PRO research results ("group-level data") to inform decision making and by monitoring individual patient's PROs ("individual-level data") to inform care. We investigated the interpretability of current PRO data presentation formats. This cross-sectional mixed-methods study randomized purposively sampled cancer patients and clinicians to evaluate six group-data or four individual-data formats. A self-directed exercise assessed participants' interpretation accuracy and ratings of ease-of-understanding and usefulness (0 = least to 10 = most) of each format. Semi-structured qualitative interviews explored helpful and confusing format attributes. We reached thematic saturation with 50 patients (44 % < college graduate) and 20 clinicians. For group-level data, patients rated simple line graphs highest for ease-of-understanding and usefulness (median 8.0; 33 % selected for easiest to understand/most useful) and clinicians rated simple line graphs highest for ease-of-understanding and usefulness (median 9.0, 8.5) but most often selected line graphs with confidence limits or norms (30 % for each format for easiest to understand/most useful). Qualitative results support that clinicians value confidence intervals, norms, and p values, but patients find them confusing. For individual-level data, both patients and clinicians rated line graphs highest for ease-of-understanding (median 8.0 patients, 8.5 clinicians) and usefulness (median 8.0, 9.0) and selected them as easiest to understand (50, 70 %) and most useful (62, 80 %). The qualitative interviews supported highlighting scores requiring clinical attention and providing reference values. This study has identified preferences and opportunities for improving on current formats for PRO presentation and will inform development of best practices for PRO presentation. Both patients and clinicians prefer line graphs across group-level data and individual

  4. Patient-reported outcome measures in dysphagia: a systematic review of instrument development and validation.

    Science.gov (United States)

    Patel, D A; Sharda, R; Hovis, K L; Nichols, E E; Sathe, N; Penson, D F; Feurer, I D; McPheeters, M L; Vaezi, M F; Francis, David O

    2017-05-01

    Patient-reported outcome (PRO) measures are commonly used to capture patient experience with dysphagia and to evaluate treatment effectiveness. Inappropriate application can lead to distorted results in clinical studies. A systematic review of the literature on dysphagia-related PRO measures was performed to (1) identify all currently available measures and (2) to evaluate each for the presence of important measurement properties that would affect their applicability. MEDLINE via the PubMed interface, the Cumulative Index of Nursing and Allied Health Literature, and the Health and Psychosocial Instrument database were searched using relevant vocabulary terms and key terms related to PRO measures and dysphagia. Three independent investigators performed abstract and full text reviews. Each study meeting criteria was evaluated using an 18-item checklist developed a priori that assessed multiple domains: (1) conceptual model, (2) content validity, (3) reliability, (4) construct validity, (6) scoring and interpretation, and (7) burden and presentation. Of 4950 abstracts reviewed, a total of 34 dysphagia-related PRO measures (publication year 1987-2014) met criteria for extraction and analysis. Several PRO measures were of high quality (MADS for achalasia, SWAL-QOL and SSQ for oropharyngeal dysphagia, PROMIS-GI for general dysphagia, EORTC-QLQ-OG25 for esophageal cancer, ROMP-swallowing for Parkinson's Disease, DSQ-EoE for eosinophilic esophagitis, and SOAL for total laryngectomy-related dysphagia). In all, 17 met at least one criterion per domain. Thematic deficiencies in current measures were evident including: (1) direct patient involvement in content development, (2) empirically justified dimensionality, (3) demonstrable responsiveness to change, (4) plan for interpreting missing responses, and (5) literacy level assessment. This is the first comprehensive systematic review assessing developmental properties of all available dysphagia-related PRO measures. We

  5. The case for an international patient-reported outcomes measurement information system (PROMIS®) initiative.

    Science.gov (United States)

    Alonso, Jordi; Bartlett, Susan J; Rose, Matthias; Aaronson, Neil K; Chaplin, John E; Efficace, Fabio; Leplège, Alain; Lu, Aiping; Tulsky, David S; Raat, Hein; Ravens-Sieberer, Ulrike; Revicki, Dennis; Terwee, Caroline B; Valderas, Jose M; Cella, David; Forrest, Christopher B

    2013-12-20

    Patient-reported outcomes (PROs) play an increasingly important role in clinical practice and research. Modern psychometric methods such as item response theory (IRT) enable the creation of item banks that support fixed-length forms as well as computerized adaptive testing (CAT), often resulting in improved measurement precision and responsiveness. Here we describe and discuss the case for developing an international core set of PROs building from the US PROMIS® network.PROMIS is a U.S.-based cooperative group of research sites and centers of excellence convened to develop and standardize PRO measures across studies and settings. If extended to a global collaboration, PROMIS has the potential to transform PRO measurement by creating a shared, unifying terminology and metric for reporting of common symptoms and functional life domains. Extending a common set of standardized PRO measures to the international community offers great potential for improving patient-centered research, clinical trials reporting, population monitoring, and health care worldwide. Benefits of such standardization include the possibility of: international syntheses (such as meta-analyses) of research findings; international population monitoring and policy development; health services administrators and planners access to relevant information on the populations they serve; better assessment and monitoring of patients by providers; and improved shared decision making.The goal of the current PROMIS International initiative is to ensure that item banks are translated and culturally adapted for use in adults and children in as many countries as possible. The process includes 3 key steps: translation/cultural adaptation, calibration, and validation. A universal translation, an approach focusing on commonalities, rather than differences across versions developed in regions or countries speaking the same language, is proposed to ensure conceptual equivalence for all items. International item

  6. Measurement and control of bias in patient reported outcomes using multidimensional item response theory.

    Science.gov (United States)

    Dowling, N Maritza; Bolt, Daniel M; Deng, Sien; Li, Chenxi

    2016-05-26

    Patient-reported outcome (PRO) measures play a key role in the advancement of patient-centered care research. The accuracy of inferences, relevance of predictions, and the true nature of the associations made with PRO data depend on the validity of these measures. Errors inherent to self-report measures can seriously bias the estimation of constructs assessed by the scale. A well-documented disadvantage of self-report measures is their sensitivity to response style (RS) effects such as the respondent's tendency to select the extremes of a rating scale. Although the biasing effect of extreme responding on constructs measured by self-reported tools has been widely acknowledged and studied across disciplines, little attention has been given to the development and systematic application of methodologies to assess and control for this effect in PRO measures. We review the methodological approaches that have been proposed to study extreme RS effects (ERS). We applied a multidimensional item response theory model to simultaneously estimate and correct for the impact of ERS on trait estimation in a PRO instrument. Model estimates were used to study the biasing effects of ERS on sum scores for individuals with the same amount of the targeted trait but different levels of ERS. We evaluated the effect of joint estimation of multiple scales and ERS on trait estimates and demonstrated the biasing effects of ERS on these trait estimates when used as explanatory variables. A four-dimensional model accounting for ERS bias provided a better fit to the response data. Increasing levels of ERS showed bias in total scores as a function of trait estimates. The effect of ERS was greater when the pattern of extreme responding was the same across multiple scales modeled jointly. The estimated item category intercepts provided evidence of content independent category selection. Uncorrected trait estimates used as explanatory variables in prediction models showed downward bias. A

  7. The Impact of Participation in Online Cancer Communities on Patient Reported Outcomes: Systematic Review.

    Science.gov (United States)

    van Eenbergen, Mies C; van de Poll-Franse, Lonneke V; Heine, Peter; Mols, Floortje

    2017-09-28

    In recent years, the question of how patients' participating in online communities affects various patient reported outcomes (PROs) has been investigated in several ways. This study aimed to systematically review all relevant literature identified using key search terms, with regard to, first, changes in PROs for cancer patients who participate in online communities and, second, the characteristics of patients who report such effects. A computerized search of the literature via PubMed (MEDLINE), PsycINFO (5 and 4 stars), Cochrane Central Register of Controlled Trials, and ScienceDirect was performed. Last search was conducted in June 2017. Studies with the following terms were included: (cancer patient) and (support group or health communities) and (online or Internet). A total of 21 studies were included and independently assessed by 2 investigators using an 11-item quality checklist. The methodological quality of the selected studies varied: 12 were of high quality, eight were of adequate quality, and only one was of low quality. Most of the respondents were women (about 80%), most with breast cancer; their mean age was 50 years. The patients who were active in online support groups were mostly younger and more highly educated than the nonusers. The investigated PROs included general well-being (ie, mood and health), anxiety, depression, quality of life, posttraumatic growth, and cancer-related concerns. Only marginal effects-that is, PRO improvements-were found; in most cases they were insignificant, and in some cases they were contradictory. The main shortcoming of this kind of study is the lack of methodological instruments for reliable measurements. Furthermore, some patients who participate in online communities or interact with peers via Internet do not expect to measure changes in their PROs. If cancer survivors want to meet other survivors and share information or get support, online communities can be a trustworthy and reliable platform to facilitate

  8. Ebstein's anomaly in pregnancy: maternal and neonatal outcomes.

    Science.gov (United States)

    Chopra, Seema; Suri, Vanita; Aggarwal, Neelam; Rohilla, Meenakshi; Vijayvergiya, Rajesh; Keepanasseril, Anish

    2010-04-01

    Ebstein's anomaly is a rare congenital cardiac abnormality, associated with cyanosis and arrhythmia. Patients often reach childbearing age and pregnant women pose a challenge to the treating physician. We describe the course and outcome of pregnancy in women with Ebstein's anomaly and discuss the related management issues. Analysis of pregnancies in four women with Ebstein's anomaly was carried out in a referral institute in northern India. Data of two women were analyzed retrospectively and the other two women were prospectively followed in their pregnancies during the study period. The course of the pregnancy, disease and perinatal outcome in each woman were analyzed. Four women had eight pregnancies all resulting in vaginal deliveries. There were two premature deliveries. The mean birth weight was 2.54 + or - 0.88 kg. Of the eight babies, six did not have any cardiac anomalies; one was an unexplained neonatal death and for another, no data was available. Pregnancy was well tolerated in two patients, while one had right heart failure during early pregnancy, and one had arrhythmia during labor, which was managed medically; one patient had arrhythmia in the postpartum period, which was managed medically. When a woman with Ebstein's anomaly reaches childbearing age, fertility is not affected, even in cyanotic women. Under close supervision by the woman's obstetrician and cardiologist, the pregnancy outcome is usually favorable.

  9. High risk pregnancy in the workplace. Influencing positive outcomes.

    Science.gov (United States)

    Cannon, R B; Schmidt, J V; Cambardella, B; Browne, S E

    2000-09-01

    Childbearing employees are well served by the occupational health nurse who promotes optimal preconceptual and pregnancy health practices, uses community resources, and maintains current knowledge about high risk pregnancy prevention and care. These broad goals of care can lead to decreased absenteeism, healthier and happier employees, and more positive outcomes of pregnancy. For employees with high risk pregnancies, the role of the occupational health nurse includes, but is not limited to, facilitating awareness with the employer, making suggestions for adjusting working conditions, making frequent assessments of the employee's needs, and communicating with prenatal health care providers. Occupational health nurses should never underestimate their role and potential influence on the mother, and on her significant other, for a positive outcome of her pregnancy.

  10. Pregnancy in infertile PCOD patients. Complications and outcome.

    Science.gov (United States)

    Urman, B; Sarac, E; Dogan, L; Gurgan, T

    1997-08-01

    To evaluate the complications and outcome of pregnancy in women with polycystic ovary disease (PCOD). The course and outcome of 47 singleton pregnancies in women with well-documented PCOD were compared with those in 100 healthy controls. Women with PCOD had a significantly higher body mass index as compared to the control group (P PCOD (P PCOD subjects were compared with lean control subjects, the difference in the incidence of the above complications was still significant (P PCOD subjects were compared with obese controls. Women with PCOD were at increased risk of gestational diabetes and pregnancy-induced hypertension, and this risk appeared to be independent of body mass index.

  11. Positive pregnancy outcomes in Mexican immigrants: what can we learn?

    Science.gov (United States)

    Page, Robin L

    2004-01-01

    To provide an integrated review of the literature of potential explanations for better than expected pregnancy outcomes in Mexican immigrants, focusing on socioeconomics, social support, desirability of pregnancy, nutrition, substance use, religion, acculturation, and prenatal care. Computerized searches of MEDLINE and CINAHL databases, as well as reference lists from published articles on low birth weight and prematurity in immigrants and acculturation in immigrants from January 1989 to December 2002. Search terms were Mexican immigrant women, childbearing, and pregnancy outcome, and only English-language articles were reviewed. Literature was selected from refereed publications in the areas of nursing, medicine, public health, family, and sociology. Data were extracted using keywords pertinent to pregnancy outcome in Mexican immigrants. Despite having many of the risk factors for poor pregnancy outcomes, Mexican immigrants have superior birth outcomes when compared to U.S.-born women. Social support, familism, healthy diet, limited use of cigarettes and alcohol, and religion may play a role in improved outcomes. The superior outcomes diminish with the process of acculturation as the individual adapts to her new culture. Low birth weight and prematurity are public health concerns in the United States. Through further study of the factors that lead to superior birth outcomes among Mexican immigrant women, rates of low birth weight and prematurity in the United States may be reduced.

  12. 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.

  13. Impact of Different Treatment Approaches on Pregnancy Outcomes in 99 Women Treated for Hodgkin Lymphoma

    International Nuclear Information System (INIS)

    De Sanctis, Vitaliana; Filippone, Francesco Romeo; Alfò, Marco; Muni, Roberta; Cavalieri, Elena; Pulsoni, Alessandro; Annechini, Giorgia; Valeriani, Maurizio; Osti, Mattia Falchetto; Minniti, Giuseppe; Enrici, Riccardo Maurizi

    2012-01-01

    Purpose: The aim of this study was to evaluate the pregnancy outcomes in women with Hodgkin lymphoma (HL) diagnosis, treated between 1972 and 1999 at Department of Radiotherapy and Hematology of University “Sapienza” of Roma. Methods and Materials: We retrospectively studied 99 female patients that conceived after treatment for HL. Fifty-nine (59%) were treated with chemotherapy and radiotherapy, 32 (32%) with radiotherapy alone as supradiaphragmatic or as infradiaphragmatic and 8 (8%) patients with chemotherapy alone. Results: Ninety-nine patients reported 145 pregnancies. We observed 132 deliveries (2 of them twin births) after a median of 55 months (range, 14–278 months) from the end of therapy. Twelve women (12%) experienced 13 miscarriages after a median of 50 months (range, 13–120) from the end of therapy. We recorded 9/132 (7%) premature births and 3/134 babies (2%) were underweight at the time of birth. We recorded 2 cases of congenital malformations. No statistical differences were recorded when adverse pregnancy outcomes were analyzed with respect to chemotherapy alone, radiotherapy alone, or combined therapy. Conclusions: No significant associations between pregnancy outcomes and therapeutic approaches were found. In particular, the infradiaphragmatic radiotherapy showed no statistical association with miscarriages, premature birth, and low birth weight at term when compared with other therapeutic approaches.

  14. Development of a Short Version of the Thyroid-Related Patient-Reported Outcome ThyPRO

    DEFF Research Database (Denmark)

    Watt, Torquil; Bjorner, Jakob Bue; Groenvold, Mogens

    2015-01-01

    BACKGROUND: Thyroid diseases affect quality of life (QoL). The Thyroid-Related Patient-Reported Outcome (ThyPRO) is an international comprehensive well-validated patient-reported outcome, measuring thyroid-related QoL. The current version is rather long-85 items. The purpose of the present study...... was to develop an abbreviated version of the ThyPRO, with conserved good measurement properties. METHODS: A cross-sectional (N = 907) and a longitudinal sample (N = 435) of thyroid patients were analyzed. A graded item response theory (IRT) model was fitted to the cross-sectional data. Short-form scales.......89-0.98), and the mean scale levels were similar. CONCLUSIONS: A 39-item version of the ThyPRO, with good measurement properties, was developed and is recommended for clinical use....

  15. Prolonged Pregnancy: Methods, Causal Determinants and Outcome

    DEFF Research Database (Denmark)

    Olesen, Annette Wind

    ) to study the incidence of prolonged pregnancy as a function of methods for determining gestational age; 2) to determine the risk of obstetrical and fetal complications in prolonged pregnancy; 3) to validate the self-reported gestational age in the National Birth Cohort; 4) to determine whether...... an ultrasound scan in the first or second trimester, or menstrual history was best at predicting the day of delivery; 5) to study the risk of recurrence of prolonged pregnancy as a function of change in male partner, social status and municipality; and 6) to detect prenatal risk indicators of prolonged...... of perinatal and obstetrical complications was high in post-term delivery compared to term delivery (OR between 1.2 and 3.1). The risk of perinatal death (OR=1.36 (1.08-1.72)) was also higher in the post-term group (I). The self-reported gestational ages in the National Birth Cohort correlated well with data...

  16. Pregnancy outcome of monochorionic twins: does amnionicity matter?

    Science.gov (United States)

    Dias, Thiran; Contro, Elena; Thilaganathan, Basky; Khan, Hina; Zanardini, Cristina; Mahsud-Dornan, Samina; Bhide, Amar

    2011-12-01

    To compare the fetal loss rate of monochorionic (MC) twin pregnancies according to their amnionicity. A retrospective review of all MC pregnancy outcomes in a tertiary centre. Pregnancy outcomes were compared for monochorionic monoamniotic (MCMA) versus monochorionic diamniotic (MCDA) pregnancies. 29 MCMA and 117 MCDA twin pregnancies were identified. The overall fetal loss rate was significantly higher in MCMA (23/52, 44.2%) compared to MCDA pregnancies (28/233, 12%, Chi squared = 30.03, p fetal survival rate in MCDA twins were significantly higher than in MCMA twins (Log-rank Chi-squared = 27.9, p fetal losses in some MCMA twins. After exclusion of identifiable causes, the difference in fetal survival was not significant in the two groups (Log-rank chi-squared = 0.373, p = .54). The loss rate for MCMA twins is high and occurs mainly due to discordant congenital abnormality, conjoint twins or twin reversed arterial perfusion (TRAP) sequence. Although the fetal loss rate in MCDA is lower than in MCMA pregnancies, the majority of fetal loss in MCDA pregnancies cannot be predicted at the first scan at presentation. The data of this study questions the widespread policy of a difference in the scheduling of elective delivery for MCMA and MCDA twins.

  17. Patient-Reported Allergies Predict Worse Outcomes After Hip and Knee Arthroplasty: Results From a Prospective Cohort Study.

    Science.gov (United States)

    Otero, Jesse E; Graves, Christopher M; Gao, Yubo; Olson, Tyler S; Dickinson, Christopher C; Chalus, Rhonda J; Vittetoe, David A; Goetz, Devon D; Callaghan, John J

    2016-12-01

    Retrospective analyses have demonstrated correlation between patient-reported allergies and negative outcomes after total joint arthroplasty. We sought to validate these observations in a prospective cohort. One hundred forty-four patients undergoing total hip arthroplasty and 302 patients undergoing total knee arthroplasty were prospectively enrolled. Preoperatively, patients listed their allergies and completed the Medical Outcomes Study Short Form 36 (SF-36) and the Charlson Comorbidity Index (CCI) Questionnaire. At a mean of 17 months (range 12-25 months) postoperatively, SF-36, CCI, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) were obtained by telephone survey. Regression analysis was used to determine the strength of correlation between patient age, comorbidity burden, and number of allergies and outcome measurements. In 446 patients, 273 reported at least 1 allergy. The number of allergies reported ranged from 0 to 33. Penicillin or its derivative was the most frequently reported allergy followed by sulfa, environmental allergen, and narcotic pain medication. Patients reporting at least 1 allergy had a significantly lower postoperative SF-36 Physical Component Score compared to those reporting no allergies (51.3 vs 49.4, P = .01). The SF-36 postoperative Mental Component Score was no different between groups. Multivariate regression analysis showed that age and patient reported allergies, but not comorbidities, were independently associated with worse postoperative SF-36 Physical Component Summary (PCS) and WOMAC score. Patients with allergies experienced the same improvement in SF-36 PCS as those without an allergy. Comorbidities did not correlate with patient-reported function postoperatively. Patients who report allergies have lower postoperative outcome scores but may experience the same increment in improvement after total joint arthroplasty. Copyright © 2016 Elsevier Inc. All rights reserved.

  18. Patient experiences with oily skin: The qualitative development of content for two new patient reported outcome questionnaires

    OpenAIRE

    Arbuckle, Robert; Atkinson, Mark J; Clark, Marci; Abetz, Linda; Lohs, Jan; Kuhagen, Ilka; Harness, Jane; Draelos, Zoe; Thiboutot, Diane; Blume-Peytavi, Ulrike; Copley-Merriman, Kati

    2008-01-01

    Abstract Objective To develop the content for two new patient reported outcome (PRO) measures to: a) assess the severity of symptoms; and b) the impact of facial skin oiliness on emotional wellbeing using qualitative data from face to face, and internet focus groups in Germany and the US. Methods Using input from initial treatment satisfaction focus groups (n = 42), a review of relevant literature and expert clinicians (n = 3), a discussion guide was developed to guide qualitative inquiry usi...

  19. Day-to-day measurement of patient-reported outcomes in exacerbations of chronic obstructive pulmonary disease

    Science.gov (United States)

    Kocks, Jan Willem H; van den Berg, Jan Willem K; Kerstjens, Huib AM; Uil, Steven M; Vonk, Judith M; de Jong, Ynze P; Tsiligianni, Ioanna G; van der Molen, Thys

    2013-01-01

    Background Exacerbations of chronic obstructive pulmonary disease (COPD) are a major burden to patients and to society. Little is known about the possible role of day-to-day patient-reported outcomes during an exacerbation. This study aims to describe the day-to-day course of patient-reported health status during exacerbations of COPD and to assess its value in predicting clinical outcomes. Methods Data from two randomized controlled COPD exacerbation trials (n = 210 and n = 45 patients) were used to describe both the feasibility of daily collection of and the day-to-day course of patient-reported outcomes during outpatient treatment or admission to hospital. In addition to clinical parameters, the BORG dyspnea score, the Clinical COPD Questionnaire (CCQ), and the St George’s Respiratory Questionnaire were used in Cox regression models to predict treatment failure, time to next exacerbation, and mortality in the hospital study. Results All patient-reported outcomes showed a distinct pattern of improvement. In the multivariate models, absence of improvement in CCQ symptom score and impaired lung function were independent predictors of treatment failure. Health status and gender predicted time to next exacerbation. Five-year mortality was predicted by age, forced expiratory flow in one second % predicted, smoking status, and CCQ score. In outpatient management of exacerbations, health status was found to be less impaired than in hospitalized patients, while the rate and pattern of recovery was remarkably similar. Conclusion Daily health status measurements were found to predict treatment failure, which could help decision-making for patients hospitalized due to an exacerbation of COPD. PMID:23766644

  20. Development of an online library of patient-reported outcome measures in gastroenterology: The GI-PRO database

    OpenAIRE

    Khanna, P; Agarwal, N; Khanna, D; Hays, RD; Chang, L; Bolus, R; Melmed, G; Whitman, CB; Kaplan, RM; Ogawa, R; Snyder, B; Spiegel, BM

    2014-01-01

    OBJECTIVES:Because gastrointestinal (GI) illnesses can cause physical, emotional, and social distress, patient-reported outcomes (PROs) are used to guide clinical decision making, conduct research, and seek drug approval. It is important to develop a mechanism for identifying, categorizing, and evaluating the over 100 GI PROs that exist. Here we describe a new, National Institutes of Health (NIH)-supported, online PRO clearinghouse-the GI-PRO database.METHODS: Using a protocol developed by th...

  1. Agreement between touch-screen and paper-based patient-reported outcomes for patients with fibromyalgia

    DEFF Research Database (Denmark)

    Wæhrens, Eva Elisabet Ejlersen; Amris, Kirstine; Bartels, Else Marie

    2015-01-01

    OBJECTIVES: To compare data based on computerized and paper versions of health status questionnaires (HSQs) for sampling patient-reported outcomes (PROs) in patients with fibromyalgia (FM). In addition, to examine associations between patient characteristics (age, education, computer experience......) and differences between versions. Finally, to evaluate the acceptability of computer-based questionnaires among patients with FM. METHOD: The study population comprised female patients diagnosed with FM. All patients completed six HSQs: the Fibromyalgia Impact Questionnaire (FIQ), the Major Depression Inventory...

  2. If patient-reported outcome measures are considered key health-care quality indicators, who is excluded from participation?

    Science.gov (United States)

    Kroll, Thilo; Wyke, Sally; Jahagirdar, Deepa; Ritchie, Karen

    2014-10-01

    Patient-reported outcome measures have received increasing attention with regard to ensuring quality improvement across the health service. However, there is a risk that people with disabilities and low literacy are systematically excluded from the development of these measures as well as their application in clinical practice. This editorial highlights some of these risks and the potential consequences of exclusion for these groups. © 2012 John Wiley & Sons Ltd.

  3. Feasibility of using a handheld electronic device for the collection of patient reported outcomes data from children

    OpenAIRE

    Vinney, Lisa A.; Grade, John; Connor, Nadine P.

    2011-01-01

    The manner in which a communication disorder affects health-related quality of life (QOL) in children is not known. Unfortunately, collection of quality of life data via traditional paper measures is labor intensive and has several other limitations, which hinder the investigation of pediatric quality of life in children. Currently, there is not sufficient research regarding the use of electronic devices to collect pediatric patient reported outcomes in order to address such limitations. Thus...

  4. Periodontal disease and adverse pregnancy outcomes.

    Science.gov (United States)

    Shub, Alexis; Swain, Jonathan R; Newnham, John P

    2006-09-01

    Periodontal disease is a common infectious disease in women of reproductive age. The disease is often not diagnosed and in studies of over 10 000 women has been associated with preterm birth, small for gestational age newborns, and preeclampsia. It has been shown in a smaller number of women that treatment of periodontal disease may reduce the rate of preterm birth. The pregnancy complications of periodontal disease may be due to lipopolysaccharide from the periodontal pockets inciting prostaglandin pathways controlling parturition. Three large randomized controlled trials of treatment of periodontal disease are underway and may provide confirmation of the importance of periodontal disease in causing complications of pregnancy.

  5. 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

  6. Setting the vision: applied patient-reported outcomes and smart, connected digital healthcare systems to improve patient-centered outcomes prediction in critical illness.

    Science.gov (United States)

    Wysham, Nicholas G; Abernethy, Amy P; Cox, Christopher E

    2014-10-01

    Prediction models in critical illness are generally limited to short-term mortality and uncommonly include patient-centered outcomes. Current outcome prediction tools are also insensitive to individual context or evolution in healthcare practice, potentially limiting their value over time. Improved prognostication of patient-centered outcomes in critical illness could enhance decision-making quality in the ICU. Patient-reported outcomes have emerged as precise methodological measures of patient-centered variables and have been successfully employed using diverse platforms and technologies, enhancing the value of research in critical illness survivorship and in direct patient care. The learning health system is an emerging ideal characterized by integration of multiple data sources into a smart and interconnected health information technology infrastructure with the goal of rapidly optimizing patient care. We propose a vision of a smart, interconnected learning health system with integrated electronic patient-reported outcomes to optimize patient-centered care, including critical care outcome prediction. A learning health system infrastructure integrating electronic patient-reported outcomes may aid in the management of critical illness-associated conditions and yield tools to improve prognostication of patient-centered outcomes in critical illness.

  7. Periodontal treatment during pregnancy decreases the rate of adverse pregnancy outcome: a controlled clinical trial.

    Science.gov (United States)

    Sant'Ana, Adriana Campos Passanezi; Campos, Marinele R de; Passanezi, Selma Campos; Rezende, Maria Lúcia Rubo de; Greghi, Sebastião Luiz Aguiar; Passanezi, Euloir

    2011-04-01

    The aim of this study was to evaluate the effects of non-surgical treatment of periodontal disease during the second trimester of gestation on adverse pregnancy outcomes. Pregnant patients during the 1st and 2nd trimesters at antenatal care in a Public Health Center were divided into 2 groups: NIG--"no intervention" (n=17) or IG--"intervention" (n=16). IG patients were submitted to a non-surgical periodontal treatment performed by a single periodontist consisting of scaling and root planning (SRP), professional prophylaxis (PROPH) and oral hygiene instruction (OHI). NIG received PROPH and OHI during pregnancy and were referred for treatment after delivery. Periodontal evaluation was performed by a single trained examiner, blinded to periodontal treatment, according to probing depth (PD), clinical attachment level (CAL), plaque index (PI) and sulcular bleeding index (SBI) at baseline and 35 gestational weeks-28 days post-partum. Primary adverse pregnancy outcomes were preterm birth (Periodontal treatment resulted in stabilization of CAL and PI (p>0.05) at IG and worsening of all periodontal parameters at NIG (pperiodontal conditions of IG and NIG were observed at 2nd examination (ppregnancy outcomes was 47.05% in NIG and 6.25% in IG. Periodontal treatment during pregnancy was associated to a decreased risk of developing adverse pregnancy outcomes [OR=13.50; CI: 1.47-123.45; p=0.02]. Periodontal treatment during the second trimester of gestation contributes to decrease adverse pregnancy outcomes.

  8. Inappropriate gestational weight gain among teenage pregnancies: prevalence and pregnancy outcomes

    Directory of Open Access Journals (Sweden)

    Vivatkusol Y

    2017-05-01

    Full Text Available Yada Vivatkusol, Thaovalai Thavaramara, Chadakarn Phaloprakarn Department of Obstetrics and Gynecology, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Bangkok, Thailand Objective: To study the prevalence and pregnancy outcomes of inappropriate gestational weight gain (GWG among teenage pregnant women.Methods: A retrospective descriptive study was conducted on 2,165 teenage pregnant women who attended our antenatal clinic between January 2007 and August 2015. Adverse pregnancy outcomes, including maternal and neonatal outcomes of women with inappropriate GWG, including underweight and overweight, were studied and compared with those of women with appropriate GWG.Results: Complete data of 1,943 women were obtained. Among these women, the mean age was 17.4±1.4 years and mean body mass index at first visit was 19.1±3.0 kg/m2. The prevalence of inappropriate GWG was 61.7%. Underweight women were more likely to experience anemia and preterm delivery, whereas overweight women required more cesarean sections because of cephalopelvic disproportion and preeclampsia, compared to women with appropriate weight gain (all P<0.001. The rates of gestational diabetes mellitus among women who were underweight, overweight, or appropriate weight were not significantly different.Conclusion: More than 60% of teenage pregnancies showed inappropriate GWG. GWG had a significant impact on pregnancy outcomes. Keywords: prevalence, pregnancy outcome, inappropriate gestational weight gain, teenage pregnancy

  9. Obstetrics and perinatal outcomes of dichorionic twin pregnancy following ART compared with spontaneous pregnancy

    Directory of Open Access Journals (Sweden)

    Leila Pourali

    2016-05-01

    Full Text Available Introduction: Regarding to the recent advances in assisted reproductive techniques (ART, twin and multiple pregnancies have increased during past years. Objective: This study was performed to compare obstetrics and perinatal outcomes of dichorionic twin pregnancy following ART with spontaneous pregnancy. Materials and Methods: In this cross-sectional study which was performed in Ghaem Hospital, Mashhad University of Medical Sciences, 107 dichorionic twin pregnancy were enrolled in two groups: spontaneous group (n=96 and ART group (n=31. Basic criteria and obstetrics and neonatal outcomes information including demographic data, gestational age, mode of delivery, pregnancy complications (preeclampsia, gestational diabetes, preterm labor, and intrauterine growth retardation (IUGR, postpartum hemorrhage, neonatal outcomes (weight, first and fifth minuteP PApgar score, Neonatal Intensive Care Unit (NICU admission, mortality, respiratory distress, and icterus were recorded using a questionnaire. Results: Preterm labor, gestational diabetes, and preeclampsia were significantly higher in ART group compared to spontaneous pregnancy group. However, other factors such as anemia, IUGR, postpartum hemorrhage, and intrauterine fetal death (IUFD were not significantly different between groups. There were no significant differences between groups in terms of neonatal outcomes (weight, 1PstP and 5PthP min Apgar score <7, NICU hospitalization, mortality, respiratory distress, and icterus. Conclusion: With regard of significantly higher poor outcomes such as preeclampsia, gestational diabetes and preterm labor in ART group, the couples should be aware of these potential risks before choosing ART.

  10. Fertility and pregnancy outcome in women with systemic sclerosis.

    Science.gov (United States)

    Steen, V D; Medsger, T A

    1999-04-01

    To determine fertility and pregnancy outcome in women with systemic sclerosis (SSc; scleroderma) who had disease onset before age 45 years. All living women with scleroderma who had first been evaluated at the University of Pittsburgh Scleroderma Clinic after January 1, 1972 were sent a detailed self-administered questionnaire in 1986 specifically concerning pregnancy outcomes and infertility. This group was compared with 2 race- and age-matched control groups, one comprising women with rheumatoid arthritis (RA) and one comprising healthy neighborhood women identified by random-digit dialing. We determined the number, history, treatment, and outcome of women who either had never been pregnant or had attempted to become pregnant unsuccessfully for more than 1 year. We also obtained data regarding pregnancy outcomes, including the frequency of miscarriage, premature births, small full-term infants, perinatal deaths, and births of live healthy infants. The study group comprised 214 women with SSc, 167 with RA, and 105 neighborhood controls. There were no significant differences in the overall rates of miscarriage, premature births, small full-term births, or neonatal deaths between the 3 groups. Women with SSc were more likely than those without SSc to have adverse outcomes of pregnancy after the onset of their rheumatic disease, particularly premature births (also seen in RA women after disease onset) and small full-term infants. Although a significantly greater number of women with SSc had never been pregnant, there were no significant differences in the frequency of never having been pregnant or of infertility in the 3 groups after adjustment for contributing factors. This study indicates that women with SSc have acceptable pregnancy outcomes compared with those of women with other rheumatic disease and healthy neighborhood controls. Infertility was not a frequent problem. We believe that there are no excessive pregnancy risks to women with SSc or their infants

  11. Pregnancy Outcome in Cervical Incompetence: Comparison of ...

    African Journals Online (AJOL)

    Context: Cervical incompetence is a major cause of recurrent mid-trimester pregnancy loss and preterm deliveries; it contributes significantly to fetal loss and neonatal morbidity and mortality. Despite its wide use, the effectiveness of cervical cerclage in its management remains unsettled. Objective: To evaluate the ...

  12. 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.

  13. Patient-reported outcomes of catheter-based accelerated partial breast brachytherapy and whole breast irradiation, a single institution experience.

    Science.gov (United States)

    Jethwa, Krishan R; Kahila, Mohamed M; Mara, Kristin C; Harmsen, William S; Routman, David M; Pumper, Geralyn M; Corbin, Kimberly S; Sloan, Jeff A; Ruddy, Kathryn J; Hieken, Tina J; Park, Sean S; Mutter, Robert W

    2018-05-01

    Accelerated partial breast irradiation (APBI) and whole breast irradiation (WBI) are treatment options for early-stage breast cancer. The purpose of this study was to compare patient-reported-outcomes (PRO) between patients receiving multi-channel intra-cavitary brachytherapy APBI or WBI. Between 2012 and 2015, 131 patients with ductal carcinoma in situ (DCIS) or early stage invasive breast cancer were treated with adjuvant APBI (64) or WBI (67) and participated in a PRO questionnaire. The linear analog scale assessment (LASA), harvard breast cosmesis scale (HBCS), PRO-common terminology criteria for adverse events- PRO (PRO-CTCAE), and breast cancer treatment outcome scale (BCTOS) were used to assess quality of life (QoL), pain, fatigue, aesthetic and functional status, and breast cosmesis. Comparisons of PROs were performed using t-tests, Wilcoxon rank-sum, Chi square, Fisher exact test, and regression methods. Median follow-up from completion of radiotherapy and questionnaire completion was 13.3 months. There was no significant difference in QoL, pain, or fatigue severity, as assessed by the LASA, between treatment groups (p > 0.05). No factors were found to be predictive of overall QoL on regression analysis. BCTOS health-related QoL scores were similar between treatment groups (p = 0.52).The majority of APBI and WBI patients reported excellent/good breast cosmesis, 88.5% versus 93.7% (p = 0.37). Skin color change (p = 0.011) and breast elevation (p = 0.01) relative to baseline were more common in the group receiving WBI. APBI and WBI were both associated with favorable patient-reported outcomes in early follow-up. APBI resulted in a lesser degree of patient-reported skin color change and breast elevation relative to baseline.

  14. Pregnancy, Obstetric and Neonatal Outcomes in HIV Positive ...

    African Journals Online (AJOL)

    While the effect of HIV infection on some maternal outcomes is well established, for some others there is conflicting information on possible association with HIV. In this study we investigated pregnancy and neonatal outcome of HIV positive women in large HIV treatment centre over a period of 84 months. They were ...

  15. Obstetric outcome of twin pregnancies in Jos, Nigeria | Mutihir ...

    African Journals Online (AJOL)

    Obstetric outcome of twin pregnancies in Jos, Nigeria. JT Mutihir, VC Pam. Abstract. Objectives: The objectives of the study were to determine the incidence, maternal and foetal outcome of twin delivery in Jos, Nigeria. Methodology: All consecutive twin deliveries between August 2003 and November 2004 were studied.

  16. Periodontal disease and adverse pregnancy outcomes: a systematic review.

    Science.gov (United States)

    Xiong, X; Buekens, P; Fraser, W D; Beck, J; Offenbacher, S

    2006-02-01

    Recent studies suggest that periodontal disease, as a source of subclinical and persistent infection, may induce systemic inflammatory responses that increase the risk of adverse pregnancy outcomes. To examine the existing evidence on the relationship between periodontal disease and adverse pregnancy outcomes. Published studies identified via searches of the MEDLINE, EMBASE, CINAHL, and Current Contents full-text databases. We identified and selected observational studies (i.e. case-control, cross-sectional, and cohort) and nonrandomised controlled studies or randomised controlled trials that examined periodontal disease as a risk factor for adverse pregnancy outcomes. Odds ratios (OR) or risk ratios (RR) were extracted or calculated from the studies' data. We calculated pooled effect size for two clinical controlled trials but not for the observational studies due to the heterogeneity in definitions for periodontal disease and adverse pregnancy outcomes across studies. Twenty-five studies (13 case-control, 9 cohort, and 3 controlled trials) were identified. The studies focused on preterm low birthweight, low birthweight, preterm birth, birthweight by gestational age, miscarriage or pregnancy loss, and pre-eclampsia. Of the chosen studies, 18 suggested an association between periodontal disease and increased risk of adverse pregnancy outcome (ORs ranging from 1.10 to 20.0) and 7 found no evidence of an association (ORs ranging from 0.78 to 2.54). Three clinical trial studies suggest that oral prophylaxis and periodontal treatment can lead to a 57% reduction in preterm low birthweight (pooled RR 0.43; 95% CI 0.24-0.78) and a 50% reduction in preterm births (RR 0.5; 95% CI 0.20-1.30). Periodontal disease may be associated with an increased risk of adverse pregnancy outcome. However, more methodologically rigorous studies are needed for confirmation.

  17. Development of the AOSpine Patient Reported Outcome Spine Trauma (AOSpine PROST) : A universal disease-specific outcome instrument for individuals with traumatic spinal column injury

    NARCIS (Netherlands)

    Sadiqi, Said; Lehr, A. Mechteld; Post, Marcel W.; Dvorak, Marcel F.; Kandziora, Frank; Rajasekaran, S.; Schnake, Klaus J.; Vaccaro, Alexander R.; Oner, F. Cumhur

    To report on the multi-phase process used in developing the AOSpine Patient Reported Outcome Spine Trauma (AOSpine PROST), as well as the results of its application in a pilot study. The International Classification of Functioning, Disability and Health (ICF) methodology was used as the basis for

  18. Successful Pregnancy Outcome In Maternal Crigler Najjar Syndrome Type II

    Directory of Open Access Journals (Sweden)

    Shakuntala PN

    2012-10-01

    Full Text Available Estimated incidence of Crigler-Najjar syndrome(CNS is 1 case per 1,000,000 births(1 million. The overall prevalence of CN syndrome is unknown, with only several hundred people reported to have this disease. It is interestingly very rare to encounter a pregnant adult women with congenital jaundice. Pregnancy in CN type II patients is a diagnostic and a therapeutic challenge because of the high risk of bilirubin encephalopathy with serious neurological damage as life-threatening complications for the fetus. To date 8 pregnancy outcome have been reported from 5 women and we report the6 woman with a successful 9 th pregnancy outcome. We have discussed detail history, presentation and management during pregnancy and care of the new born.

  19. Poor pregnancy outcome in women with type 2 diabetes

    DEFF Research Database (Denmark)

    Clausen, Tine D; Mathiesen, Elisabeth; Ekbom, Pia

    2005-01-01

    . Pregnancy outcome was compared with that of pregnant women with type 1 diabetes during 1996-2000, the background population, and pregnant women with type 2 diabetes during 1980-1992 from the same department. RESULTS: The perinatal mortality in pregnancies complicated by type 2 diabetes (4/61, 6.......6%) was increased four- and ninefold, respectively, and the rate of major congenital malformations (4/60, 6.7%) was more than doubled, although not statistically significant, compared with type 1 diabetic pregnancies and the background population. The glycemic control was similar or better in women with type 2...... diabetes compared with women with type 1 diabetes. Multivariate logistic regression analysis in the pooled group of pregnancies with pregestational diabetes from 1996 to 2001 showed that high HbA(1c) at admission and type 2 diabetes were independently associated with a serious adverse fetal outcome...

  20. NTP Monograph: Developmental Effects and Pregnancy Outcomes Associated With Cancer Chemotherapy Use During Pregnancy.

    Science.gov (United States)

    2013-05-01

    The National Toxicology Program (NTP) Office of Health Assessment and Translation (OHAT) conducted an evaluation of the developmental effects and pregnancy outcomes associated with cancer chemotherapy use during pregnancy in humans. The final NTP monograph was completed in May 2013 (available at http:// ntp.niehs.nih.gov/go/36495). The incidence of cancer during pregnancy has been reported to occur from 17 to 100 per 100,000 pregnant women. Chemotherapy is a common treatment for cancer; however, most chemotherapy agents are classified as known or suspected human teratogens. Cancer chemotherapy use during pregnancy was selected for evaluation by the NTP because of the: (1) paucity of comprehensive reviews on the pregnancy outcomes following cancer chemotherapy use during pregnancy in humans, including the integration of the developmental animal toxicology literature with the observational studies in humans, and (2) growing public interest in the developmental effects of chemotherapy on offspring exposed to cancer chemotherapy during gestation due to the expected incidence of cancer diagnosed during pregnancy as women delay pregnancy to later ages. Of the approximately 110 cancer chemotherapeutic agents currently in use, the NTP monograph includes data on 56 agents used during 1,261 pregnancies for which pregnancy outcomes were documented. Overall, the NTP evaluation found that treatment with chemotherapy for cancer appeared to be associated with: (1) a higher rate of major malformations following exposure during the first trimester compared to exposure in the second and/or third trimester; (2) an increase the rate of stillbirth following exposure in the second and/ or third trimester; abnormally low levels of amniotic fluid (primarily attributable to Trastuzumab); and (3), also data are insufficient, impaired fetal growth and myelosuppression. Treatment with chemotherapy for cancer during pregnancy did not appear to increase spontaneous preterm birth, or impair

  1. Deflation of gastric band balloon in pregnancy for improving outcomes.

    Science.gov (United States)

    Jefferys, Amanda E; Siassakos, Dimitrios; Draycott, Tim; Akande, Valentine A; Fox, Robert

    2013-04-30

    In line with the rise in the prevalence of obesity, an increasing number of women of childbearing age are undergoing laparoscopic adjustable gastric banding (LAGB), resulting in an increasing number of pregnancies with a band in place. Currently, there is no consensus on optimal band management in pregnancy. Some clinicians advocate leaving the band balloon inflated to reduce gestational weight gain and associated adverse perinatal outcomes. However, there are concerns that maintaining balloon inflation during pregnancy might increase the risk of band complications and adversely affect fetal development and/or growth as a result of reduced nutritional intake. To compare maternal and perinatal outcomes for elective gastric band balloon deflation versus intention to maintain balloon inflation during pregnancy. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 September 2012) and the Web of Science database (1940 to September 2012). Randomised-controlled trials comparing elective deflation of the gastric band balloon with intention to maintain balloon inflation in pregnant women who have undergone LAGB. Two review authors independently assessed studies for inclusion. No studies met the criteria for inclusion in the review. To date no randomised controlled trials exist that compare elective deflation of the gastric band balloon in pregnancy versus intention to maintain balloon inflation. Further research is needed to define the optimum management of the gastric band balloon in pregnancy.

  2. Pregnancy outcome in a woman with prune belly syndrome.

    Science.gov (United States)

    Hillman, R Tyler; Garabedian, Matthew James; Wallerstein, Robert J

    2012-11-30

    Prune belly syndrome is a rare congenital syndrome that primarily affects male fetuses. Affected men are universally infertile; however, there is a paucity of information published on the reproductive potential of affected women. Pregnancy outcomes in affected women have not been described in the literature. We describe the case of pregnancy in an affected woman. Her pregnancy progressed without complication. Her fetus had no stigmata of the syndrome. Her labour and delivery were, however, complicated by a prolonged second stage of labour and need for vacuum-assisted vaginal delivery.

  3. Substance use during pregnancy and postnatal outcomes

    DEFF Research Database (Denmark)

    Irner, Tina Birk; Teasdale, Thomas William; Tine, Nielsen

    2012-01-01

    mothers continued to use substances throughout their pregnancies were born at a lower gestational age (Chi-Square = 15.1(2), P alcohol and those with no substance exposure. The same children were more...... pregnancy, as well as their background, and to examine the effect substance use has on gestational age, birth weight, and the development of neonatal abstinence syndrome at birth. A sample of 161 pregnant women and their 163 newborn children were included. The results indicate that the children whose...... vulnerable to the development of neonatal abstinence syndrome at birth (Chi-Square = 51.7(2), P alcohol in utero were at a significant risk of being born with low birth weight (Chi-Square = 8.8(2), P

  4. Fetomaternal Outcome in Triplet and Quadruplet Pregnancies: A Retrospective Study

    Directory of Open Access Journals (Sweden)

    Maasoumeh Mirzamoradi

    2017-06-01

    Full Text Available Background: In recent decades, there has been a dramatic increase in the prevalence of multiple pregnancies. An important reason is the increased use of assisted reproductive techniques for conception. Despite the advances in prenatal care, maternal and neonatal morbidity and mortality caused by multiple pregnancies are still high. Aim: This study aimed to evaluate the fetomaternal complications in higher order multiple pregnancies. Design: The design is a retrospective study. Setting: Triplet and quadruplet pregnancies were investigated in this study. Methods: This study investigated the outcome of triplet and quadruplet pregnancies born alive at the Mahdiyeh hospital, Tehran, Iran from 2006 to 2015. Results: In this study, 111 triplet pregnancies and 24 quadruplet pregnancies were studied, 80% of which resulted from assisted reproductive technology. The average age of pregnancy termination was 31 weeks, the average weight of the first to third neonates was 1400 g and the average weight of the fourth neonate was 700 g. The most common reason for early termination of pregnancy was preterm labor, the most maternal complication was uterine atony and the most common neonatal complication was pre-maturity and then respiratory distress syndrome (RDS. The mean age of mother in triplets’ deliveries was significantly lower than in the quadruplets. The average weight of the first to third neonates, the average of 1st and 5th minutes Apgar score of the first neonates and the average gestational age of termination for the first and second neonates in triplets was significantly higher than in the quadruplets. Hospitalization due to preterm labor in quadruplets’ delivery was significantly higher than in triplets. Conclusion: Higher order multiple pregnancies are associated with higher maternal and neonatal complications. Mothers with such pregnancies needs more care in the prenatal period, during labor and in the postpartum period, and also their

  5. Pregnancy outcome in hyperthyroidism: a case control study.

    Science.gov (United States)

    Aggarawal, Neelam; Suri, Vanita; Singla, Rimpi; Chopra, Seema; Sikka, Pooja; Shah, Viral N; Bhansali, Anil

    2014-01-01

    Data comparing pregnancy outcome in hyperthyroid women with euthyroid women are scarce. Hence, this study was carried out to assess the maternal and fetal outcome in pregnant women with hyperthyroidism to ascertain the effect of disease on pregnancy. This retrospective study was conducted over a period of 28 years. We compared the maternal and fetal outcomes of 208 hyperthyroid women with 403 healthy controls, between women with well-controlled and uncontrolled disease and amongst women diagnosed with hyperthyroidism before and during pregnancy. Maternal outcome: women with hyperthyroidism were at increased risk for preeclampsia (OR = 3.94), intrauterine growth restriction (OR = 2.16), spontaneous preterm labor (OR = 1.73), preterm birth (OR = 1.7), gestational diabetes mellitus (OR = 1.8), and cesarean delivery (OR = 1.47). Hyperthyroid women required induction of labor more frequently (OR = 3.61). Fetal outcome: newborns of hyperthyroid mothers had lower birth weight than normal ones (p = 0.0001). Women with uncontrolled disease had higher odds for still birth (OR = 8.42; 95% CI: 2.01-35.2) and lower birth weight (p = 0.0001). Obstetrical complications were higher in women with hyperthyroidism than normal women. Outcome was worsened by uncontrolled disease. Women with pregestational hyperthyroidism had better outcomes than those diagnosed with it during pregnancy. © 2014 S. Karger AG, Basel.

  6. Patient anxiety and concern as predictors for the perceived quality of treatment and patient reported outcome (PRO) in orthopaedic surgery

    DEFF Research Database (Denmark)

    Bilberg, Randi; Nørgaard, Birgitte; Overgaard, Søren

    2012-01-01

    ABSTRACT: BACKGROUND: Previous studies have shown that patients' anxiety and dissatisfaction are predictors for increased postoperative pain and reduced efficacy of pain treatment. However, it remains to be shown whether patient anxiety and concern are predictors for the perceived quality...... of treatment and patient reported outcome (PRO).The aim of this study is to investigate whether there is a correlation between preoperative anxiety and concern, and the perceived quality of postoperative treatment and outcome. The hypothesis is that anxious and concerned patients are less satisfied...... with treatment and have a poorer outcome.Methods/designThis study is designed as a prospective follow-up study and has the aim of investigating the correlation between patient anxiety and concern, patients[ACUTE ACCENT] perceived quality of treatment and outcome. This correlation will be detected using five...

  7. Relationships between pregnancy outcomes, biochemical markers and pre-pregnancy body mass index.

    Science.gov (United States)

    Han, Y S; Ha, E H; Park, H S; Kim, Y J; Lee, S S

    2011-04-01

    We examined the relationships between pre-pregnancy maternal body mass index (BMI), pregnancy outcomes and biochemical markers. This study was conducted as a cross-sectional analysis. Korean women in their second and third trimesters of pregnancy were recruited at two hospitals in the metropolitan Seoul area. Pre-pregnancy BMI was categorized in four groups according to the Asia-Pacific standard. Fasting blood samples were obtained and analyzed for serum levels of homocysteine, folate and high-sensitivity C-reactive protein (hs-CRP). Concentrations of fetal fibronectin were assessed in the cervix and vagina, and cervical length was measured. Obese subjects had a lower education level and a lower income level than subjects of normal weight. The level of maternal stress was positively associated with pre-pregnancy BMI. Normal weight subjects were more likely to eat breakfast and consume meals of appropriate size than the rest of our sample. In overweight and obese subjects, weight gain during pregnancy was significantly lower than in the underweight and normal subjects. High pre-pregnancy maternal BMI increased the risks of preterm delivery (odds ratio (OR)=2.85, confidence interval (CI)=1.20-6.74), low-birth-weight (LBW) infants (overweight subjects: OR=5.07, CI=1.76-14.63; obese subjects: OR=4.49, CI=1.54-13.13) and macrosomia. In obese subjects, the average serum folate level was significantly lower than in the underweight subjects. In obese subjects, the average serum hs-CRP level was significantly higher than in the rest of our sample. Pregnancy outcomes are influenced by pre-pregnancy BMI. These findings suggest that women can minimize their risks of preterm delivery, LBW and macrosomia by maintaining normal pre-pregnancy BMI.

  8. Periodontal disease and pregnancy outcomes: state-of-the-science.

    Science.gov (United States)

    Xiong, Xu; Buekens, Pierre; Vastardis, Sotirios; Yu, Stell M

    2007-09-01

    To examine the existing evidence on the relationship between periodontal disease and adverse pregnancy outcomes, we conducted a systematic review of studies published up to December 2006. Studies published in full text were identified by searching computerized databases (e.g., MEDLINE, EMBASE). A meta-analysis was performed to pool the effect size of the clinical trials. Forty-four studies were identified (26 case-control studies, 13 cohort studies, and 5 controlled trials). The studies focused on preterm low birth weight, low birth weight, preterm birth, birth weight by gestational age, miscarriage or pregnancy loss, preeclampsia, and gestational diabetes mellitus. Of the chosen studies, 29 suggested an association between periodontal disease and increased risk of adverse pregnancy outcome (odds ratios [ORs] ranging from 1.10 to 20.0) and 15 found no evidence of an association (ORs ranging from 0.78 to 2.54). A meta-analysis of the clinical trials suggested that oral prophylaxis and periodontal treatment may reduce the rate of preterm low birth weight (pooled risk ratio (RR): 0.53, 95% confidence interval [CI]: 0.30-0.95, P 0.05) or low birth weight (pooled RR: 0.86, 95% CI: 0.58%1.29, P > 0.05). The authors conclude that periodontal disease may be associated with increased risk of adverse pregnancy outcomes. More methodologically rigorous studies are needed in this field. Currently, there is insufficient evidence to support the provision of periodontal treatment during pregnancy for the purpose of reducing adverse pregnancy outcomes. Obstetricians & Gynecologists, Family Physicians. After completion of this article, the reader should be able to state that the published literature is not vigorous to clinically link periodontal disease and/or its treatment to specific adverse pregnancy outcomes, and explain that more rigorous studies with world-wide agreed-upon definitions are particularly needed before periodontal disease treatment can be recommended.

  9. Pregnancy outcome and ultraviolet radiation; A systematic review

    Energy Technology Data Exchange (ETDEWEB)

    Megaw, Lauren, E-mail: lauren.megaw@ed.ac.uk [School of Women' s and Infants Health, University of Western Australia, 35 Crawley Ave, Crawley, Perth, Western Australia (Australia); Edinburgh Tommy' s Centre for Reproductive Health, Queen' s Medical Research Institute, University of Edinburgh, 47 Little France Crescent, Edinburgh (United Kingdom); Clemens, Tom, E-mail: Tom.clemens@ed.ac.uk [School of Geosciences, University of Edinburgh, Drummond St, Edinburgh, Midlothian (United Kingdom); Dibben, Chris, E-mail: Chris.dibben@ed.ac.uk [School of Geosciences, University of Edinburgh, Drummond St, Edinburgh, Midlothian (United Kingdom); Weller, Richard, E-mail: Richard.weller@ed.ac.uk [MRC Centre for Inflammation Research, Queen' s Medical Research Institute, University of Edinburgh, 47 Little France Crescent, Edinburgh (United Kingdom); Stock, Sarah, E-mail: Sarah.stock@ed.ac.uk [School of Women' s and Infants Health, University of Western Australia, 35 Crawley Ave, Crawley, Perth, Western Australia (Australia); Edinburgh Tommy' s Centre for Reproductive Health, Queen' s Medical Research Institute, University of Edinburgh, 47 Little France Crescent, Edinburgh (United Kingdom)

    2017-05-15

    Background: Season and vitamin D are indirect and direct correlates of ultraviolet (UV) radiation and are associated with pregnancy outcomes. Further to producing vitamin D, UV has positive effects on cardiovascular and immune health that may support a role for UV directly benefitting pregnancy. Objectives: To investigate the effects of UV exposure on pregnancy; specifically fetal growth, preterm birth and hypertensive complications. Methods: We conducted a systematic review of Medline, EMBASE, DoPHER, Global Health, ProQuest Public Health, AustHealth Informit, SCOPUS and Google Scholar to identify 537 citations, 8 of which are included in this review. This review was registered on PROSPERO and a. narrative synthesis is presented following PRISMA guidance. Results: All studies were observational and assessed at high risk of bias. Higher first trimester UV was associated with and improved fetal growth and increased hypertension in pregnancy. Interpretation is limited by study design and quality. Meta-analysis was precluded by the variety of outcomes and methods. Discussion: The low number of studies and risk of bias limit the validity of any conclusions. Environmental health methodological issues are discussed with consideration given to design and analytical improvements to further address this reproductive environmental health question. Conclusions: The evidence for UV having benefits for pregnancy hypertension and fetal growth is limited by the methodological approaches utilized. Future epidemiological efforts should focus on improving the methods of modeling and linking widely available environmental data to reproductive health outcomes. - Highlights: • Biologically plausible pathways support an association between ultraviolet radiation (UV) and pregnancy outcomes. • This study is the first systematic review of prevailing literature on the relationship between UV and singleton pregnancy outcomes. • It focuses on both substantive findings and the

  10. Pregnancy outcome and ultraviolet radiation; A systematic review

    International Nuclear Information System (INIS)

    Megaw, Lauren; Clemens, Tom; Dibben, Chris; Weller, Richard; Stock, Sarah

    2017-01-01

    Background: Season and vitamin D are indirect and direct correlates of ultraviolet (UV) radiation and are associated with pregnancy outcomes. Further to producing vitamin D, UV has positive effects on cardiovascular and immune health that may support a role for UV directly benefitting pregnancy. Objectives: To investigate the effects of UV exposure on pregnancy; specifically fetal growth, preterm birth and hypertensive complications. Methods: We conducted a systematic review of Medline, EMBASE, DoPHER, Global Health, ProQuest Public Health, AustHealth Informit, SCOPUS and Google Scholar to identify 537 citations, 8 of which are included in this review. This review was registered on PROSPERO and a. narrative synthesis is presented following PRISMA guidance. Results: All studies were observational and assessed at high risk of bias. Higher first trimester UV was associated with and improved fetal growth and increased hypertension in pregnancy. Interpretation is limited by study design and quality. Meta-analysis was precluded by the variety of outcomes and methods. Discussion: The low number of studies and risk of bias limit the validity of any conclusions. Environmental health methodological issues are discussed with consideration given to design and analytical improvements to further address this reproductive environmental health question. Conclusions: The evidence for UV having benefits for pregnancy hypertension and fetal growth is limited by the methodological approaches utilized. Future epidemiological efforts should focus on improving the methods of modeling and linking widely available environmental data to reproductive health outcomes. - Highlights: • Biologically plausible pathways support an association between ultraviolet radiation (UV) and pregnancy outcomes. • This study is the first systematic review of prevailing literature on the relationship between UV and singleton pregnancy outcomes. • It focuses on both substantive findings and the

  11. Exploration, Development, and Validation of Patient-reported Outcomes in Antineutrophil Cytoplasmic Antibody–associated Vasculitis Using the OMERACT Process

    Science.gov (United States)

    Robson, Joanna C.; Milman, Nataliya; Tomasson, Gunnar; Dawson, Jill; Cronholm, Peter F.; Kellom, Katherine; Shea, Judy; Ashdown, Susan; Boers, Maarten; Boonen, Annelies; Casey, George C.; Farrar, John T.; Gebhart, Don; Krischer, Jeffrey; Lanier, Georgia; McAlear, Carol A.; Peck, Jacqueline; Sreih, Antoine G.; Tugwell, Peter; Luqmani, Raashid A.; Merkel, Peter A.

    2016-01-01

    Objective Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is a group of linked multisystem life- and organ-threatening diseases. The Outcome Measures in Rheumatology (OMERACT) vasculitis working group has been at the forefront of outcome development in the field and has achieved OMERACT endorsement of a core set of outcomes for AAV. Patients with AAV report as important some manifestations of disease not routinely collected through physician-completed outcome tools; and they rate common manifestations differently from investigators. The core set includes the domain of patient-reported outcomes (PRO). However, PRO currently used in clinical trials of AAV do not fully characterize patients’ perspectives on their burden of disease. The OMERACT vasculitis working group is addressing the unmet needs for PRO in AAV. Methods Current activities of the working group include (1) evaluating the feasibility and construct validity of instruments within the PROMIS (Patient-Reported Outcome Measurement Information System) to record components of the disease experience among patients with AAV; (2) creating a disease-specific PRO measure for AAV; and (3) applying The International Classification of Functioning, Disability and Health to examine the scope of outcome measures used in AAV. Results The working group has developed a comprehensive research strategy, organized an investigative team, included patient research partners, obtained peer-reviewed funding, and is using a considerable research infrastructure to complete these interrelated projects to develop evidence-based validated outcome instruments that meet the OMERACT filter of truth, discrimination, and feasibility. Conclusion The OMERACT vasculitis working group is on schedule to achieve its goals of developing validated PRO for use in clinical trials of AAV. (First Release September 1 2015; J Rheumatol 2015;42:2204–9; doi:10.3899/jrheum.141143) PMID:26329344

  12. Mental health in early pregnancy is associated with pregnancy outcome in women with pregestational diabetes

    DEFF Research Database (Denmark)

    Callesen, N F; Secher, A L; Cramon, P

    2015-01-01

    -related quality of life, anxiety, depression and locus of control were seen in women delivering large or appropriate for gestational age infants. CONCLUSIONS: Poor mental quality of life and the presence of depressive symptoms in early pregnancy were associated with preterm delivery in women with pregestational......AIM: To explore the role of early pregnancy health-related quality of life, anxiety, depression and locus of control for pregnancy outcome in women with pregestational diabetes. METHODS: This was a cohort study of 148 pregnant women with pregestational diabetes (118 with Type 1 diabetes and 30...... with Type 2 diabetes), who completed three internationally validated questionnaires: the 36-item Short-Form Health Survey, the Hospital Anxiety and Depression Scale and the Multidimensional Health Locus of Control survey at 8 weeks. Selected pregnancy outcomes were preterm delivery (

  13. Urinary tract infection and adverse outcome of pregnancy.

    Science.gov (United States)

    Dimetry, Shaira R; El-Tokhy, Hanan M; Abdo, Nagla M; Ebrahim, Moustafa A; Eissa, Mohammed

    2007-01-01

    Urinary tract infections (UTIs) during pregnancy are among the commonest health problems world wide, specially in developing countries, including Egypt. It has several adverse outcomes not only on the mother but also on the fetus as well.. The aim of this study is to determine the incidence of UTIs during pregnancy, study the main risk factors associated with such infections and find the impact of these infections on some pregnancy outcomes namely the gestational age and birth weight. A follow-up study on 249 pregnant women attending the ante natal care clinic at Zagazig university hospital. They were recruited over a period from 1st of September to 30th of or November, 2005. The outcome could be recorded for 201 of them. Data were collected through a pretested questionnaire, repeated urine analyses and recording of outcome of pregnancy. The study revealed that the incidence of UTIs during pregnancy was 31.3%. The commonest organisms were Klebsiella and E-coli. Several socio-demographic characteristics were found significantly associated with UTIs, age being 30 years and more, illiterates and low educational level, low socio-economic level and those with unsatisfactory personal hygiene and those using underwear clothes other than cotton. Significant associations with UTIs were also found in multigravidae 4th and more, those having more than one child and those who previously suffered UTIs. The only predicting variable with UTIs was low socio-economic level. The study revealed that the probability of delivering premature infants and low birth weights was significantly higher among those who experienced UTIs during pregnancy. Multivariate analysis revealed that UTI was one of the main contributors to pre-mature deliveries. Urinary tract infections with pregnancy still constitute a big problem with high incidence. It has a great impact on pregnancy outcome mainly pre-mature labor. So, the study recommends health education about personal hygiene, repeated urine

  14. Pregnancy Outcomes and Surgical Management of Pregnancy Complicated By Appendicitis: Obstetrician View

    Directory of Open Access Journals (Sweden)

    Deniz Şimşek

    2015-08-01

    Full Text Available Objective: To evaluate the pregnancy outcomes of patients who underwent appendectomy during pregnancy. Materials and Methods: Patients who underwent appendectomy between years 2010 and 2014 were retrospectively evaluated. All patients’ pregnancy outcomes were followed-up by using university registry system and telephone interview. Patients were evaluated regarding age, gestational age, clinical and laboratory examinations, imaging studies, mean time interval between emergency department and operation, mean operative time, pregnancy outcome and pathologic results of the appendix. Results: Thirty-nine patients were included in the study. Sixteen of 39 patients were in the first, 15 of them in the second and 8 of them were in the third trimester of the pregnancy. Three patients underwent laparoscopic appendectomy and the rest underwent laparotomy. In pathologic evaluation of the appendix, seven patients (17% had normal appendix, 4 patients had perforated appendix, one patient had neuro-endocrine tumor and rest of the patients had appendicitis. Two missed abortion occurred after operation, rest of the patients had live birth. Six of them were preterm and 31 had term birth. Twelve patients delivered through vaginal birth and the rest via caesarean section. Twenty patients were in the first half of the pregnancy (group 1 and 19 patients were in the second half of the pregnancy (group 2. There were no significant differences between the groups in operation time and mean time interval between emergency administration and operation. Conclusion: Delayed operation and negative appendectomy can cause adverse pregnancy outcomes. Expectant management in suspected cases may decrease negative appendectomy rates but can also lead to perforation. Computed tomography and MRI ought to be considered if ultrasonography is inconclusive. Tocolytic regimens can be administered to prevent threatened preterm labor. Obstetric indications were valid for delivery mode.

  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. Does continuous use of metformin throughout pregnancy improve pregnancy outcomes in women with polycystic ovarian syndrome?

    Science.gov (United States)

    Nawaz, Fauzia Haq; Khalid, Roha; Naru, Tahira; Rizvi, Javed

    2008-10-01

    Polycystic ovarian syndrome (PCOS) is one of the most common endocrinopathies in women of reproductive age. It is associated with hyperinsulinemia and insulin resistance which is further aggravated during pregnancy. This mechanism has a pivotal role in the development of various complications during pregnancy. In the past few years, metformin, an insulin sensitizer, has been extensively evaluated for induction of ovulation. Its therapeutic use during pregnancy is, however, a recent strategy and is a debatable issue. At present, evidence is inadequate to support the long-term use of insulin-sensitizing agents during pregnancy. It is a challenge for both clinicians and researchers to provide good evidence of the safety of metformin for long-term use and during pregnancy. This study aimed to evaluate pregnancy outcomes in women with PCOS who conceived while on metformin treatment, and continued the medication for a variable length of time during pregnancy. This case-control study was conducted from January 2005 to December 2006 at the antenatal clinics of the Department of Obstetrics and Gynecology, Aga Khan University, Karachi, Pakistan. The sample included 137 infertile women with PCOS; of these, 105 conceived while taking metformin (cases), while 32 conceived spontaneously without metformin (controls). Outcomes were measured in three groups of cases which were formed according to the duration of use of metformin during pregnancy. Comparison was made between these groups and women with PCOS who conceived spontaneously. All 137 women in this study had a confirmed diagnosis of PCOS (Rotterdam criteria). These women were followed up during their course of pregnancy; data forms were completed once they had delivered. Cases were divided into three groups: group A, 40 women who stopped metformin between 4-16 weeks of pregnancy; group B, 20 women who received metformin up until 32 weeks of gestation; and group C; 45 women who continued metformin throughout pregnancy. All

  17. Outcome of pregnancy in survivors of Wilms' tumor

    International Nuclear Information System (INIS)

    Li, F.P.; Gimbrere, K.; Gelber, R.D.; Sallan, S.E.; Flamant, F.; Green, D.M.; Heyn, R.M.; Meadows, A.T.

    1987-01-01

    Outcome of pregnancy was reported by 99 patients who were cured of childhood Wilms' tumor at seven pediatric cancer centers during 1931 to 1979. These patients carried or sired 191 singleton pregnancies of at least 20 weeks in duration. Among the 114 pregnancies in women who had received abdominal radiotherapy for Wilms' tumor, an adverse outcome occurred in 34 (30%). There were 17 perinatal deaths (five in premature low-birth-weight infants) and 17 other low-birth-weight infants. Compared with white women in the United States, the irradiated women had an increased perinatal mortality rate (relative risk, 7.9) and an excess of low-birth-weight infants (relative risk, 4.0). In contrast, an adverse outcome was found in two (3%) of the 77 pregnancies in nonirradiated female patients with Wilms' tumor and wives of male patients. The high risk of adverse pregnancy outcome should be considered in the counseling and prenatal care of women who have received abdominal radiotherapy for Wilms' tumor

  18. Analysis of Pregnancy Outcomes among Interracial Couples in Korea.

    Science.gov (United States)

    Yang, Sun Young; Jung, Un Suk; Hong, Hye Ri; Hwang, Soon Young; Oh, Min Jeong; Kim, Hai Joong; Cho, Geum Joon

    2017-10-01

    Although the prevalence of interracial marriages in Korea is increasing, little is known regarding the pregnancy outcomes of interracial couples. The aim of this study was to investigate the differences in pregnancy outcomes between Korean and interracial Korean-foreign couples. Data for infants born in 2011 and 2012 were obtained from the national birth registry of the Korean Statistical Office. The couples were subdivided into Korean father-Korean mother, Korean father-foreign mother, and foreign father-Korean mother groups. Pregnancy outcomes included neonates with low birth weight ( 4,000 g). In 2010 and 2011, 888,447 Korean father-Korean mother, 36,024 Korean father-foreign mother, and 4,955 foreign father-Korean mother neonates were delivered in Korea. After adjustment for parental age, educational level, parity, gestational age at delivery, and neonatal sex, the birth weights were found to be different between groups, with the highest number of foreign father-Korean mother and lowest number of Korean father-foreign mother pregnancies. Based on multivariate logistic regression analysis, the risk of low and large birth weights was higher in the Korean father-foreign mother and foreign father-Korean mother groups, respectively, compared with that in the Korean father-Korean mother group. There are significant differences in pregnancy outcomes including birth weights between Korean and interracial Korean-foreign couples. © 2017 The Korean Academy of Medical Sciences.

  19. Periodontal treatment during pregnancy decreases the rate of adverse pregnancy outcome: a controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Adriana Campos Passanezi Sant'Ana

    2011-04-01

    Full Text Available OBJECTIVES: The aim of this study was to evaluate the effects of non-surgical treatment of periodontal disease during the second trimester of gestation on adverse pregnancy outcomes. MATERIAL AND METHODS: Pregnant patients during the 1st and 2nd trimesters at antenatal care in a Public Health Center were divided into 2 groups: NIG - "no intervention" (n=17 or IG- "intervention" (n=16. IG patients were submitted to a non-surgical periodontal treatment performed by a single periodontist consisting of scaling and root planning (SRP, professional prophylaxis (PROPH and oral hygiene instruction (OHI. NIG received PROPH and OHI during pregnancy and were referred for treatment after delivery. Periodontal evaluation was performed by a single trained examiner, blinded to periodontal treatment, according to probing depth (PD, clinical attachment level (CAL, plaque index (PI and sulcular bleeding index (SBI at baseline and 35 gestational weeks-28 days post-partum. Primary adverse pregnancy outcomes were preterm birth (0.05 at IG and worsening of all periodontal parameters at NIG (p<0.0001, except for PI. Signifcant differences in periodontal conditions of IG and NIG were observed at 2nd examination (p<0.001. The rate of adverse pregnancy outcomes was 47.05% in NIG and 6.25% in IG. Periodontal treatment during pregnancy was associated to a decreased risk of developing adverse pregnancy outcomes [OR=13.50; CI: 1.47-123.45; p=0.02]. CONCLUSIONS: Periodontal treatment during the second trimester of gestation contributes to decrease adverse pregnancy outcomes.

  20. Patient reported allergies are a risk factor for poor outcomes in total hip and knee arthroplasty.

    Science.gov (United States)

    Graves, Christopher M; Otero, Jesse E; Gao, Yubo; Goetz, Devon D; Willenborg, Melissa D; Callaghan, John J

    2014-09-01

    We evaluated 459 patients undergoing THA or TKA who completed preoperative and postoperative WOMAC and/or SF36 surveys. Medical comorbidities and reported allergies were also recorded. Evaluation of surveys was compared for patients with or without 4 or more reported allergies using statistical methods. Patients with 4 or more reported allergies had less improvement on SF36 Physical Component Score (∆PCS=4.2) than those with 0-3 allergies (∆PCS=10.0, P=0.0002). Regression analysis showed that this change was independent of self-reported comorbidities. Patients reporting 4 or more allergies also had less improvement in WOMAC function (∆F=21.4) than those with 0-3 allergies (∆F = 27.2, P=0.036). Similar nonsignificant trends occurred in SF36 mental and WOMAC pain and stiffness scores. Copyright © 2014 Elsevier Inc. All rights reserved.

  1. Patient-reported outcomes among patients using exenatide twice daily or insulin in clinical practice in six European countries

    DEFF Research Database (Denmark)

    Reaney, Matthew; Mathieu, Chantal; Ostenson, Claes-Göran

    2013-01-01

    who did not meet this endpoint) and Diabetes Health Profile-18 scores (versus the main cohorts). High levels of missing data were observed for all PRO measures in both cohorts compared with those for clinical outcomes. CONCLUSIONS: These data from a clinical practice study support those from clinical...... clinical practice are lacking. We examined PROs in patients initiating injectable treatment in the CHOICE (CHanges to treatment and Outcomes in patients with type 2 diabetes initiating InjeCtablE therapy) study. METHODS: CHOICE was a 24-month, prospective observational study conducted in six European......BACKGROUND: Improvements in the clinical condition of patients with type 2 diabetes are often accompanied by improvements in health-related quality of life and other patient-reported outcomes (PROs), but data assessing injectable treatment initiation from the patient's perspective in routine...

  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. Pregnancy after bariatric surgery: the effect of time-to-conception on pregnancy outcomes.

    Science.gov (United States)

    Yau, Patricia O; Parikh, Manish; Saunders, John K; Chui, Patricia; Zablocki, Tara; Welcome, Akuezunkpa Ude

    2017-11-01

    At our medical center, female patients who have undergone bariatric surgery are advised to defer pregnancy for 2 years after surgery to avoid the following complications and their potential consequences for the fetus: inadequate gestational weight gain, inadequate postsurgical weight loss, hyperemesis gravidarum, nutritional deficiencies, gestational diabetes, and gestational hypertension. To examine the effect of time from surgery to conception on pregnancy course and outcomes in bariatric patients. University. We identified 73 pregnancies in 54 women who became pregnant after undergoing bariatric surgery. Surgery to conception interval was compared between pregnancies that were carried to delivery and 8 pregnancies that resulted in spontaneous abortion. Of 41 pregnancies that were carried to delivery, 26 occurred in women who had undergone surgery less than 2 years before conception, and 15 occurred in women who had undergone surgery greater than 2 years before conception. Gestational age at delivery, number of neonatal intensive care unit admissions, gestational weight gain, hyperemesis gravidarum, nutritional deficiencies, gestational diabetes, and gestational hypertension during pregnancy were compared for the 2 groups. Eight patients who had spontaneous abortion had a significantly shorter time from surgery to conception. There were no significant differences between our 2 groups in rates of preterm deliveries, neonatal intensive care unit admission, gestational weight gain, hyperemesis, nutritional deficiencies, gestational diabetes, or gestational hypertension. Becoming pregnant within the first 2 years after bariatric surgery appears to have no effect on pregnancy course and outcomes. Women who miscarried had a significantly lower mean surgery to conception interval. These results fail to show an increased rate of pregnancy complications during the first 2 years after bariatric surgery. Copyright © 2017 American Society for Bariatric Surgery. Published by

  4. Sex Differences in Patient-Reported Outcomes After Anterior Cruciate Ligament Reconstruction: Data From the Swedish Knee Ligament Register

    DEFF Research Database (Denmark)

    Ageberg, Eva; Forssblad, Magnus; Herbertsson, Pär

    2010-01-01

    BACKGROUND: Female gender is a risk factor for sustaining anterior cruciate ligament (ACL) injury. However, little is known about possible sex differences in patients with ACL injury/reconstruction. PURPOSE: To study sex differences in patient-reported outcomes before and at 1 and 2 years after ACL...... in KOOS and EQ-5D preoperatively, 1 and 2 years postoperatively, and over time. RESULTS: Preoperatively, female patients reported worse scores than male patients in 4 KOOS subscales (pain, symptoms, sport/recreation, quality of life) and EQ-5D, with the largest difference seen in KOOS sport....../recreation (mean difference, 4.7; 95% confidence interval [CI], 3.0-6.3). At 1 year postoperatively, female patients reported worse scores than male patients in KOOS pain (mean difference, 1.4; 95% CI, 0.4-2.4) and KOOS sport/recreation (mean difference, 2.7; 95% CI, 0.9-4.4) and at 2 years postoperatively in KOOS...

  5. Diabetes technology: improving care, improving patient-reported outcomes and preventing complications in young people with Type 1 diabetes.

    Science.gov (United States)

    Prahalad, P; Tanenbaum, M; Hood, K; Maahs, D M

    2018-04-01

    With the evolution of diabetes technology, those living with Type 1 diabetes are given a wider arsenal of tools with which to achieve glycaemic control and improve patient-reported outcomes. Furthermore, the use of these technologies may help reduce the risk of acute complications, such as severe hypoglycaemia and diabetic ketoacidosis, as well as long-term macro- and microvascular complications. In addition, diabetes technology can have a beneficial impact on psychosocial health by reducing the burden of diabetes. Unfortunately, diabetes goals are often unmet and people with Type 1 diabetes too frequently experience acute and long-term complications of this condition, in addition to often having less than ideal psychosocial outcomes. Increasing realization of the importance of patient-reported outcomes is leading to diabetes care delivery becoming more patient-centred. Diabetes technology in the form of medical devices, digital health and big data analytics have the potential to improve clinical care and psychosocial support, resulting in lower rates of acute and chronic complications, decreased burden of diabetes care, and improved quality of life. © 2018 Diabetes UK.

  6. 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.

  7. A RETROSPECTIVE STUDY OF OBSTETRIC OUTCOME IN TEENAGE PREGNANCY AND OLDER PREGNANCIES

    Directory of Open Access Journals (Sweden)

    Anita Valsaladevi

    2017-07-01

    Full Text Available BACKGROUND Younger age pregnancy of the group 18 years to 19 years is characterized by adverse maternal outcomes like anaemia, hypertension, low birth weight babies and intra uterine growth restriction. A comparative retrospective study on the obstetric outcome in teenage mothers and older women was carried out. Data for the study was obtained from a hospital where considerable teenage pregnancy is reported. Evidence obtained in this study regarding antenatal complications and birth weight shows that good antenatal care and support by family and caregivers can bring down the incidence of anaemia and low birth weight babies in teenage pregnancy. The aim of the study is to compare the obstetric outcome of pregnancy in teenagers and older women in a tertiary care hospital. MATERIALS AND METHODS This was a retrospective study conducted in Government Medical College, Manjeri, Malappuram, Kerala, India for a period of three months from March 2017 to May 2017. This is a teaching hospital with annual delivery rate of around 3500. Obstetric outcome of young mothers in the age group 18 -19 years were compared to older women (20-38 years delivering in the same hospital. A total of 843 deliveries were considered, out of which 87 belonged to teenage group. They were compared in terms of social and educational data, age, number of pregnancy, antenatal care, complications, mode of delivery, birth weight, episiotomy and perineal tears. RESULTS The incidence of teenage pregnancy was fairly high. (10.3% Most of them were in their first pregnancy. A significant number of teenage pregnant mothers (72.4% had completed higher secondary education as compared to (27.6% in older women. Contrary to many prior studies, teenage pregnancies showed less anaemia (6.9% versus 12% and lesser incidence of low birth weight babies in comparison to older women. Preterm birth was higher in teenage group (33.1% and incidence of hypertensive disorders and intrauterine growth

  8. Patient-Reported Outcome (PRO) questionnaires for young-aged to middle-aged adults with hip and groin disability

    DEFF Research Database (Denmark)

    Thorborg, K.; Tijssen, M.; Habets, B.

    2015-01-01

    BACKGROUND/AIM: To recommend Patient-Reported Outcome (PRO) questionnaires to measure hip and groin disability in young-aged to middle-aged adults. METHODS: A systematic review was performed in June 2014. The methodological quality of the studies included was determined using the COnsensus......-based Standards for the selection of health Measurement INstruments list (COSMIN) together with standardised evaluations of measurement properties of each PRO. RESULTS: Twenty studies were included. Nine different questionnaires for patients with hip disability, and one for hip and groin disability, were...

  9. 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

  10. Day-to-day measurement of patient-reported outcomes in exacerbations of chronic obstructive pulmonary disease

    Directory of Open Access Journals (Sweden)

    Kocks JWH

    2013-06-01

    Full Text Available Jan Willem H Kocks,1,2 Jan Willem K van den Berg,3 Huib AM Kerstjens,2,4 Steven M Uil,3 Judith M Vonk,2,5 Ynze P de Jong,3 Ioanna G Tsiligianni,1,2 Thys van der Molen1,2 1Department of General Practice, 2Groningen Research Institute for Asthma and COPD, University of Groningen, University Medical Center Groningen, Groningen, 3Department of Pulmonary Diseases, Isala Klinieken, Zwolle, 4Department of Pulmonary Diseases and Tuberculosis, 5Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands Background: Exacerbations of chronic obstructive pulmonary disease (COPD are a major burden to patients and to society. Little is known about the possible role of day-to-day patient-reported outcomes during an exacerbation. This study aims to describe the day-to-day course of patient-reported health status during exacerbations of COPD and to assess its value in predicting clinical outcomes. Methods: Data from two randomized controlled COPD exacerbation trials (n = 210 and n = 45 patients were used to describe both the feasibility of daily collection of and the day-to-day course of patient-reported outcomes during outpatient treatment or admission to hospital. In addition to clinical parameters, the BORG dyspnea score, the Clinical COPD Questionnaire (CCQ, and the St George's Respiratory Questionnaire were used in Cox regression models to predict treatment failure, time to next exacerbation, and mortality in the hospital study. Results: All patient-reported outcomes showed a distinct pattern of improvement. In the multivariate models, absence of improvement in CCQ symptom score and impaired lung function were independent predictors of treatment failure. Health status and gender predicted time to next exacerbation. Five-year mortality was predicted by age, forced expiratory flow in one second % predicted, smoking status, and CCQ score. In outpatient management of exacerbations, health status was found

  11. Feasibility of using a handheld electronic device for the collection of patient reported outcomes data from children.

    Science.gov (United States)

    Vinney, Lisa A; Grade, John D; Connor, Nadine P

    2012-01-01

    The manner in which a communication disorder affects health-related quality of life (QOL) in children is not known. Unfortunately, collection of quality of life data via traditional paper measures is labor intensive and has several other limitations, which hinder the investigation of pediatric quality of life in children. Currently, there is not sufficient research regarding the use of electronic devices to collect pediatric patient reported outcomes in order to address such limitations. Thus, we used a cross-over design to compare responses to a pediatric health quality of life instrument (PedsQL 4.0) delivered using a handheld electronic device to those from a traditional paper form. Respondents were children with (n=9) and without (n=10) a speech or voice disorder. For paper versus the electronic format, we examined time to completion, number of incomplete or inaccurate question responses, intra-rater reliability, ease of use, and child and parent preference. There were no significant differences between children's scores, time to complete the measure, or ratings related to ease of answering questions. The percentage of children who made answering errors or omissions with paper and pencil was significantly greater than the percentage of children who made such errors using the device. This preliminary study demonstrated that use of an electronic device to collect QOL or patient-reported outcomes (PRO) data from children is more efficient than and just as feasible, reliable, and acceptable as using paper forms. The development of hardware and software applications for the collection of QOL and/or PRO data in children with speech disorders is likely warranted. The reader will be able to understand: (1) The potential benefits of using electronic data capture via handheld devices for collecting pediatric patient reported outcomes; (2) The Pediatric Quality of Life Inventory 4.0 is a measure of the perception of general health quality that has distinguished between

  12. Gestational diabetes mellitus: glycemic control during pregnancy and neonatal outcomes of twin and singleton pregnancies.

    Science.gov (United States)

    Guillén-Sacoto, María Augusta; Barquiel, Beatriz; Hillman, Natalia; Burgos, María Ángeles; Herranz, Lucrecia

    2018-04-20

    To assess the impact of glycemic control in gestational on neonatal weight and metabolic complications of twin and singleton pregnancies. An observational, retrospective study to monitor 120 twin and 240 singleton pregnancies in women with GDM. Maternal glycemic parameters during pregnancy (oral glucose tolerance test results, treatment, insulinization rate, mean HbA1c in the third trimester), and neonatal complications and weight were recorded. A higher infant birth weight ratio (IBWR 1.02±0.12 vs. 0.88±0.12, P<.001) and a lower rate of newborns small for gestational age (severe SGA 2.5% vs. 8.3%, P=.012) were seen after singleton pregnancies as compared to twin pregnancies. The rates of newborns large for gestational age (LGA 12.6% vs. 12.5%, P=.989); macrosomic (6.7% vs. 7.5%, P=.777); or small for gestational age (SGA 6.7% vs. 10.8%, P=.175) were similar in both groups. Neonates from twin pregnancies had a higher risk of hypoglycemia (adjusted OR 4.71; 1.38-16.07, P=.013) and polycythemia (adjusted OR 10.05; 1.82-55.42, P=0.008). A linear relationship was seen between third trimester HbA1c levels and IBWR in singleton (r=.199, P=.003), but not in twin pregnancies (r=0.049, P=0.610). Risk of severe SGA, hypoglycemia, and polycythemia was significantly higher in twin pregnancies of women with GDM. Neonatal weight outcomes and metabolic complications in twin pregnancies of women with GDM were not related to glycemic control. Moreover, in our study population, fasting glucose at diagnosis and mean HbA1c in the third trimester showed a linear relationship with higher birth weights in singleton, but not in twin pregnancies. Copyright © 2018 SEEN y SED. Publicado por Elsevier España, S.L.U. All rights reserved.

  13. Does Uterine Fibroid Adversely Affect Obstetric Outcome of Pregnancy?

    Directory of Open Access Journals (Sweden)

    Hend S. Saleh

    2018-01-01

    Full Text Available Background. Fibroid is the most common benign tumor of the uterus and if associated with pregnancy may adversely affect the outcome of pregnancy. Objective of the present study was to assess the obstetric outcome (maternal and fetal in pregnancy with fibroid. Methods. A prospective observational study was performed over a period from May 2015 to August 2017 at Obstetrics and Gynecology Department in Zagazig University Hospitals, Egypt. 64 pregnant patients with >2 cm fibroid were taken in the study. Routine fundamental investigations were done for all. They were followed during antenatal period clinically and scanned by ultrasonogram which was done at booking visit and during subsequent visits to assess the change in the size of the fibroid and other obstetric complications. Maternal age, parity, size of fibroid, complications during pregnancy, and mode of delivery were noted. Results. 64 pregnant patients with uterine fibroids were recruited; 47 of them completed the study to the end. The average age was 31.80±3.27 years, body mass index (BMI [calculated as weight in kilograms divided by the square of height in meters] was 24.67±2.46, primigravida was 23.4%, multigravida was 76.6%, duration of menstrual cycle/day was 29.68±3.10, and duration of menstrual period/day was 6.46±1.12. The percentage of spontaneous conception was 59.57% and 40.43% for using assisted reproductive technology. The results of obstetric outcome were spontaneous abortion in 2%, premature delivery in 27.7%, and delivery at 37–41 weeks of pregnancy in 70.2%. The mode of delivery was vaginal delivery in 15% and cesarean sections in 85%. Also, 34% had threatened miscarriage, 21% had preterm labor, 2% had antepartum bleeding in the form of placenta previa, 4% had abdominal pain needing admission, one of them underwent laparotomy and was diagnosed as red degeneration, 2 (4% had postpartum hemorrhage, and only one needed blood transfusion. Cesarean sections were done in

  14. Association of maternal periodontal health with adverse pregnancy outcome.

    Science.gov (United States)

    Kumar, Ashok; Basra, Minu; Begum, Nargis; Rani, Vigya; Prasad, Sudha; Lamba, Arundeep Kaur; Verma, Mahesh; Agarwal, Sarita; Sharma, Shashi

    2013-01-01

    The present study aims to determine the association of periodontal disease (identified early in pregnancy) and adverse pregnancy outcomes in a North Indian population.   A total of 340 primigravida women, aged 20-35 years with single live pregnancy were recruited at 14-20 weeks period of gestation from the antenatal clinic. These women had undergone periodontal examination at time of recruitment. The pregnancy outcomes were recorded. Out of 340 primigravida women, 147 (43.23%) women had gingivitis and 61 (17.94%) women had periodontitis. Periodontitis was found to be significantly associated with pre-eclampsia, intrauterine growth restriction, preterm delivery, and low birthweight with odds ratios (95% confidence interval) of 7.48 (2.72-22.42), 3.35 (1.20-9.55), 2.72 (1.30-5.68) and 3.03 (1.53-5.97), respectively. The study shows a significant association between periodontitis (but not with gingivitis) and adverse pregnancy outcomes. Maternal periodontitis is associated with an increased risk of pre-eclampsia, intrauterine growth restriction, preterm delivery and low birthweight infants. © 2012 The Authors. Journal of Obstetrics and Gynaecology Research © 2012 Japan Society of Obstetrics and Gynecology.

  15. Composite scores in comparative effectiveness research: counterbalancing parsimony and dimensionality in patient-reported outcomes.

    Science.gov (United States)

    Schwartz, Carolyn E; Patrick, Donald L

    2014-07-01

    When planning a comparative effectiveness study comparing disease-modifying treatments, competing demands influence choice of outcomes. Current practice emphasizes parsimony, although understanding multidimensional treatment impact can help to personalize medical decision-making. We discuss both sides of this 'tug of war'. We discuss the assumptions, advantages and drawbacks of composite scores and multidimensional outcomes. We describe possible solutions to the multiple comparison problem, including conceptual hierarchy distinctions, statistical approaches, 'real-world' benchmarks of effectiveness and subgroup analysis. We conclude that comparative effectiveness research should consider multiple outcome dimensions and compare different approaches that fit the individual context of study objectives.

  16. The usefulness of a mobile device-based system for patient-reported outcomes in a spine outpatient clinic.

    Science.gov (United States)

    Kim, Chi Heon; Chung, Chun Kee; Choi, Yunhee; Shin, HyunJeong; Woo, Ji Won; Kim, Sung-Mi; Lee, Hyuk-Joon

    2016-07-01

    Patient-reported outcomes (PROs) are typically collected using a paper form, but this format is cumbersome to incorporate into outpatient clinic visits as well as in research. Therefore, we developed a mobile device-based system (mobile system) for spinal PRO. We hypothesized that this system may improve the quality of care in an outpatient clinic. This study aimed to analyze the patient-reported efficacy of a mobile system through a survey of patients' responses compared with a paper system. A prospective observational study was carried out. Surveys were conducted for 103 patients who had experience using both the paper and electronic systems in the outpatient clinic. Patient-reported positive response score (PRS) was the outcome measure. The survey included the characteristics of the patients (sex, age, use of smartphone, familiarity with smartphone applications, proficiency of typing with mobile device, site of pain, and education level) and eight questions in four domains: (1) efficacy in the waiting room, (2) efficacy during the clinic visit, (3) overall satisfaction, and (4) opinion about the use of this system. The response to each question was scored from 1 to 5 (1, negative; 5, positive response). The patient-reported PRS was calculated by adding the scores of the 8 questions and converting the total range to 0-100 (60, neutral). The mean PRS of the 8 questions was 79.8 (95% CI, 76.7-83.9). The mean PRS was 78.9 (75.6-82.2) at the waiting room and was 80.5 (77.1-83.9) during the clinic. The PRS for overall satisfaction and use of this system were 83.3 (79.6-87.0) and 77.1 (71.9-82.3), respectively. The use of smartphones and the proficiency of typing were independently significant predictors of PRS with an R(2) value of 0.325. The mobile device-based system improved the patient-reported efficacy in spine outpatient clinics. However, various factors such as the use of smartphones need to be considered when developing and applying mobile systems. Copyright

  17. Maternal dietary intake and pregnancy outcome.

    Science.gov (United States)

    Ferland, Suzanne; O'Brien, Huguette Turgeon

    2003-02-01

    To study the relationship between maternal diet and infant anthropometric measurements in 56 women, aged 28 +/- 5.1 years, with singleton pregnancies. The overall quality of the diet (three 24-hour recalls), including supplementation, was evaluated at 34 +/- 1.3 weeks using a total mean adequacy ratio (TMAR) of 12 nutrients. Specific interviewing techniques were used to minimize social desirability bias. Anthropometric measurements of both parents and maternal lifestyle practices were also obtained. Infant weight, crown-heel length and head circumference were measured 14.6 +/- 4.4 days after birth. Stepwise multiple regression analysis revealed that maternal diet quality (TMAR) was significantly related to infant weight (r = .039, P = .036) and crown-heel length (r = .071, P = .007). Other significant predictors included gestational age, maternal height, sex, smoking and physical activity. Maternal diet was positively associated with infant weight and crown-heel length.

  18. [Obstetric outcome in pregnancy complained with pulmonary hypertension].

    Science.gov (United States)

    Zhu, C X; Xiong, W; Yang, J; Chen, H Q; Niu, G; Wang, Z L

    2017-12-19

    Objective: To identify whether pregnancy outcomes vary by the severity of pulmonary hypertension. Methods: A retrospective study was conducted on 78 cases of pregnancies complained with pulmonary hypertension who delivered in the First Affiliated Hospital, Sun Yat-sen University from 2006 to 2016.The selected cases were divided into three groups according to severity of pulmonary hypertension: mild pulmonary hypertension group (mild PAH group) was defined as a mean pulmonary artery pressure 30-49 mmHg, moderate pulmonary hypertension (moderate PAH group) as mean pulmonary artery pressure 50-69 mmHg and severe pulmonary hypertension (severe PAH group) as mean pulmonary artery pressure 70 mmHg or greater.The clinical features, risk pregnant complication, maternal and neonatal outcomes were described between these three groups.Analysis of variance, Chi-square test was used for statistical analysis. Results: The average age of mild, moderate and severe PAH group were (31±5) years old, (31±5) years old and (27±3) years old, respectively ( P =0.050). The rate of natural fertilization ( P =0.414), parity ( P =0.527) and gestational age ( P =0.165) were similar in these three groups. In 78 pregnancies with pulmonary hypertension, 64.9% of pregnancies in mild PAH group was NYHA Ⅰ, 50.0% of moderate PAH group was NYHA Ⅱ and 54.5% of severe PAH group was NYHA Ⅲ( P pulmonary hypertension.But the severity of pulmonary hypertension affect the type of anesthesia.Close monitoring during pregnancy and timely termination of pregnancy can improve the outcome of pregnancy.

  19. Relationship between Maternal General and Specific-Pregnancy Stress, Anxiety, and Depression Symptoms and Pregnancy Outcome.

    Science.gov (United States)

    Hasanjanzadeh, Parvin; Faramarzi, Mahbobeh

    2017-04-01

    Despite scientific advances in the field of physical problems during pregnancy, the effect of mental problems on the health of pregnant women is still an important issue that needs further research. To determine the association of symptoms of stress, anxiety and depression during pregnancy and there effect on the pregnancy outcome. This was a descriptive correlational study. The population included 200 pregnant women of the urban and rural health centers affiliated with Babol University of Medical Sciences. There were 100 each in second and third trimester. Convenience multi stage cluster sampling was performed. Data collection was received through the Hospital Anxiety Depression Scale (HADS), Pregnancy Distress Questionnaire (PDQ), and Perceived Stress Scale (PSS-14) questionnaires. The correlation results showed a significant difference between variables of depression, stress, and anxiety with birth weight, birth height and head circumference and infants' APGAR score (prelationships on prediction of infant weight (B=-0.324), anxiety on prediction of infant height (B=-0.197), stress on prediction of head circumference (B=-0.350) and depression on prediction of APGAR score (B=-0.323) are effective (pdepression, anxiety and stress in pregnancy, and scheduling to avoid adverse consequences of the pregnancy outcome.

  20. Pregnancy course and outcome in women traveling to developing countries.

    Science.gov (United States)

    Sammour, Rami N; Bahous, Rabia; Grupper, Moti; Ohel, Gonen; Steinlauf, Shmuel; Schwartz, Eli; Potasman, Israel

    2012-01-01

    The issue of travel to developing countries during pregnancy has not been sufficiently studied. The aim of this study is to investigate the rate, course, and outcome of pregnancies in women who traveled to developing countries while pregnant, or became pregnant during such travel. Women visiting two major travel clinics in Israel for consultation within the years 2004 to 2009, who were pregnant or declared an intention of becoming pregnant during travel were contacted. This was followed by a telephone interview by an obstetrician with those women who were actually pregnant. Background characteristics, morbidity during travel, and pregnancy course and outcome were collected. Overall 52,430 travelers' records had been screened. Of these, we identified 49 women who were pregnant during their trip, but 3 declined participation. Of the remaining 46 women, 33 were pregnant at departure, and 13 conceived during travel. The incidence of pregnancy during travel was thus 0.93/1000 travelers. Thirty-three women traveled to East Asia, 8 to South and Central America, 5 to Africa. More than two thirds of women received pretravel vaccinations. Adherence to the World Health Organization recommendations regarding food and drink was high (87%) and travelers' diarrhea occurred in only 11% of women. Five of 22 women traveling to malarious areas had taken antimalarial prophylaxis. Six women required medical therapy during travel. Pregnancy outcome was not different from the normal population except for an unusually low rate of preterm delivery. In this cohort, travel to developing countries was not associated with adverse pregnancy outcome. Larger studies are needed to support these findings. © 2012 International Society of Travel Medicine.

  1. Status epilepticus in pregnancy: Etiology, management, and clinical outcomes.

    Science.gov (United States)

    Rajiv, Keni Ravish; Radhakrishnan, Ashalatha

    2017-11-01

    Status epilepticus (SE) in pregnancy carries significant risk to both mother and fetus. There is limited literature available on SE occurring in pregnancy world-over, with majority being from obstetric centers. All women who developed SE related to pregnancy (gestation, labor, or puerperium) between January 2000 and December 2016 were included in the study. Data were collected from our SE registry, maintained, and archived in the institute. The variables influencing the maternal and fetal outcome were compared using Student's t-test for continuous variables and Fisher's exact test for discrete variables. During the 16-year study period, a total of 348 SE events were recorded in 294 patients. Among these, there were 138 women, of which 17 had SE related to pregnancy. The etiology of SE was remote symptomatic in two and acute symptomatic in 15 patients. The various causes detected after initial evaluation for acute symptomatic SE were eclampsia (n=4), posterior reversible encephalopathy syndrome due to various causes other than eclampsia (n=6), cortical venous thrombosis (n=3), subarachnoid hemorrhage (n=1), and NMDA receptor antibody-mediated encephalitis (n=1).13 of 17 women with SE (76%) had good outcome. Majority of the fetuses had good outcomes, i.e., Category 1 (n=9, 57%). Duration of intensive care unit stay (p=0.029) and Status Epilepticus Severity Score (p=0.0324) at admission, were found to be significantly associated with poor outcomes. In any patient presenting with SE occurring in pregnancy, though eclampsia is presumed to be the most common overall cause; it is relevant to consider other etiologies such as posterior reversible encephalopathy syndrome, cortical venous thrombosis, and autoimmune encephalitis especially in cases presenting with refractory SE. Posterior reversible encephalopathy may occur in pregnancy due to diverse etiologies other than eclampsia. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. What Factors are Predictive of Patient-reported Outcomes? A Prospective Study of 337 Shoulder Arthroplasties.

    Science.gov (United States)

    Matsen, Frederick A; Russ, Stacy M; Vu, Phuong T; Hsu, Jason E; Lucas, Robert M; Comstock, Bryan A

    2016-11-01

    Although shoulder arthroplasties generally are effective in improving patients' comfort and function, the results are variable for reasons that are not well understood. We posed two questions: (1) What factors are associated with better 2-year outcomes after shoulder arthroplasty? (2) What are the sensitivities, specificities, and positive and negative predictive values of a multivariate predictive model for better outcome? Three hundred thirty-nine patients having a shoulder arthroplasty (hemiarthroplasty, arthroplasty for cuff tear arthropathy, ream and run arthroplasty, total shoulder or reverse total shoulder arthroplasty) between August 24, 2010 and December 31, 2012 consented to participate in this prospective study. Two patients were excluded because they were missing baseline variables. Forty-three patients were missing 2-year data. Univariate and multivariate analyses determined the relationship of baseline patient, shoulder, and surgical characteristics to a "better" outcome, defined as an improvement of at least 30% of the maximal possible improvement in the Simple Shoulder Test. The results were used to develop a predictive model, the accuracy of which was tested using a 10-fold cross-validation. After controlling for potentially relevant confounding variables, the multivariate analysis showed that the factors significantly associated with better outcomes were American Society of Anesthesiologists Class I (odds ratio [OR], 1.94; 95% CI, 1.03-3.65; p = 0.041), shoulder problem not related to work (OR, 5.36; 95% CI, 2.15-13.37; p factors listed above. The area under the receiver operating characteristic curve generated from the cross-validated enhanced predictive model was 0.79 (generally values of 0.7 to 0.8 are considered fair and values of 0.8 to 0.9 are considered good). The false-positive fraction and the true-positive fraction depended on the cutoff probability selected (ie, the selected probability above which the prediction would be classified as

  3. 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

  4. Do patient-reported outcomes (PROs have a role in the management of patients with cystic fibrosis?

    Directory of Open Access Journals (Sweden)

    Sam eSalek

    2012-03-01

    Full Text Available Background: Health-related quality of life (HRQoL is a rapidly growing area of expertise and the most commonly used patient-reported outcome (PRO. The impact of CF on HRQoL is liable to be great, making CF patients ideal candidates for the application of HRQoL instruments. The aims of this study were to assess the affect of CF on HRQoL, to ascertain the reliability and validity of the UKSIP and the CFQoL in the adult CF population, and to examine their role in the management of patients. Methods: Seventy participants were recruited from the All Wales Adult Cystic Fibrosis Centre at Llandough Hospital, UK. There were two stages to the study; self-report of the UKSIP and CFQoL in the first stage, and completion of the same two questionnaires seven to ten days later for the second stage. Results: The areas of HRQoL most impaired by CF were employment and concerns regarding the future. The UKSIP and CFQoL showed high internal consistency (rα=0.89-0.93 and test-retest reliability (rs=0.57-0.94, p<0.005 in the CF population. Validity was variable; with the UKSIP showing discrimination across socio-demographic factors, whilst the CFQoL showed increased sensitivity to clinical variables. Many parameters influenced patient-reported HRQoL, with the greatest correlations seen with the Borg score (p<0.005. The use of a HRQoL instrument in CF annual reviews is recommended to provide holistic patient care. The results of this study underpin the value of HRQoL as a patient-reported outcome measure in the management of adult CF.

  5. Tofacitinib or adalimumab versus placebo: patient-reported outcomes from a phase 3 study of active rheumatoid arthritis.

    Science.gov (United States)

    Strand, Vibeke; van Vollenhoven, Ronald F; Lee, Eun Bong; Fleischmann, Roy; Zwillich, Samuel H; Gruben, David; Koncz, Tamas; Wilkinson, Bethanie; Wallenstein, Gene

    2016-06-01

    To evaluate effects of tofacitinib or adalimumab on patient-reported outcomes (PROs) in patients with moderate to severe RA and inadequate responses to MTX. In this 12-month, phase 3, randomized controlled trial (ORAL Standard), patients (n = 717) receiving background MTX were randomized to tofacitinib 5 or 10 mg twice daily (BID), adalimumab 40 mg once every 2 weeks or placebo. PROs included HAQ-Disability Index, Patient Global Assessment of Arthritis, Patient Assessment of Arthritis Pain, health-related quality of life (Short Form-36 [SF-36]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) and sleep (Medical Outcomes Study-Sleep). At month 3, tofacitinib 10 mg BID treatment resulted in significant changes from baseline vs placebo across all PROs, sustained to month 12, with the highest number of patients reporting improvements ⩾minimum clinically important differences vs placebo (P tofacitinib 5 mg BID and adalimumab were similar and statistically significant vs placebo across most PROs, excluding SF-36 Mental Component Score and Social Functioning, Role Emotional, and Mental Health domains, with significantly more patients reporting improvements ⩾minimum clinically important differences. Numbers Needed to Treat were lowest for tofacitinib 10 mg BID and similar between tofacitinib 5 mg BID and adalimumab. Patients with moderate to severe RA and inadequate responses to MTX reported improvements across a broad range of PROs with tofacitinib 5 and 10 mg BID and adalimumab that were significantly superior to placebo. © The Author 2016. Published by Oxford University Press on behalf of the British Society for Rheumatology.

  6. Poor Pregnancy Outcomes among Adolecents in South Nyanza ...

    African Journals Online (AJOL)

    In this paper, we examine factor associated with poor pregnancy outcomes among teenagers in South Nyanza region of Kenya. The analysis is based on a recent WHO funded study on Adolescent safe motherhood in the region, which involved a survey of 1247 adolescents aged 12-19 and in-depth interviews with 39 of the ...

  7. Outcome of pregnancy in women with motorcycle accidents in ...

    African Journals Online (AJOL)

    Three hundred and seventeen pregnant women managed in the maternity section of the University of Teaching Hospital, Calabar as a result of motorcycle accidents were assessed to determine maternal and perinatal complications and outcome of such pregnancies. The incidence of 6.6% of all deliveries was established ...

  8. Pregnancy, Obstetric and Neonatal Outcomes in HIV Positive ...

    African Journals Online (AJOL)

    AJRH Managing Editor

    Keywords: Pregnancy, delivery, HIV, neonate, adverse outcome. Introduction. HIV-1 infection has remained a major public health challenge in sub-Saharan Africa, accounting ... practice have greatly reduced both maternal deaths .... 2010 we reverted back to triple ARV .... between the two groups in the rates of obstetric.

  9. Pregnancy outcome in singleton term breeches from a referral ...

    African Journals Online (AJOL)

    It is recommended that attention should be given to trainee obstetrician in selective external cephalic version at term and also the procedure of AVBD so as to reduce the caesarean section rate and also neonatal morbidity in term breeches in our community. Keywords: Pregnancy outcome, Singleton breech, Vaginal ...

  10. Pregnancy outcome in HIV seropositive women in Abakaliki, Nigeria ...

    African Journals Online (AJOL)

    Objective: To study the seroprevalence and the effect of HIV infection on pregnancy outcome. Methods: From January 2000 to December 2004, 231 HIV seropositve women and 200 HIV seronegative matched groups from Abakaliki, Nigeria were recruited into a prospective study and followed until delivery. Results: The HIV ...

  11. The Impact of Teenage Pregnancy on Maternal and Perinatal Outcome

    Directory of Open Access Journals (Sweden)

    Chaitra Ramachandra

    2016-05-01

    Full Text Available To study the impact of teenage pregnancy on maternal and perinatal outcome. This is a randomized prospective clinical study carried out in the Obstetrics and Gynaecology department, BGS Global Medical College, over a period of one year from January 2015 to December 2015. In study group (Group A included a total of 200 primigravid teenage mothers(age <20 years and the control group included 200 primigavid adult mothers (20- 30years of age . The maternal status, labour progress, delivery characteristics and neonatal outcomes were reviewed and analysed. Proportion of mothers in the study group who delivered vaginally was 61.5% compared to 80.5% in the control group. Instrumental delivery rate, emergency LSCS and elective LSCS rates were higher in the study group (teenage pregnancy compared to the control group. (9.5% Vs 5%, 17% Vs 9.5%, 12% Vs 5% respectively. Anaemia, Premature Rupture of Membranes, Oligohydraminos, Post partum Haemorrhage was found to be higher among teenage mothers when compared to adult mothers. PIH, polyhydraminos were found to be higher in control group than in the study group. In regard to adverse perinatal outcomes, higher risks of intra uterine growth restriction, preterm births, stillbirths, low APGAR scores, NICU admission were higher were higher in the study group compared to the control group. In this study, we found that women with teenage pregnancies were at increased risk for adverse pregnancy outcomes in regard to maternal, foetal and neonatal complications as compared with adult control mothers.

  12. Impact of noise and air pollution on pregnancy outcomes

    NARCIS (Netherlands)

    Gehring, Ulrike; Tamburic, Lillian; Sbihi, Hind; Davies, Hugh W.; Brauer, Michael

    2014-01-01

    Background: Motorized traffic is an important source of both air pollution and community noise. While there is growing evidence for an adverse effect of ambient air pollution on reproductive health, little is known about the association between traffic noise and pregnancy outcomes. Methods: We

  13. Socio-demographic characteristics and pregnancy outcome of ...

    African Journals Online (AJOL)

    Low social class of unbooked women influenced their not booking; this in turn resulted in poorer pregnancy outcome such as higher interventions, obstructed labour, perinatal and maternal mortality. Low education, husbands occupation and social class of unbooked women influenced their not booking; this in turn resulted ...

  14. Trichomonas infection in pregnancy does it affect perinatal outcome ...

    African Journals Online (AJOL)

    Trichomonas infection in pregnancy does it affect perinatal outcome? S.M. Ross, A. van Middelkoop. Abstract. Antenatal patients free of Trichomonas vaginalis vaginal infection were compared with infected patients, half of whom were treated and half left untreated. The treated group was given. benzoyl metronidazole 50 ml ...

  15. Pregnancy outcome in women involved in road traffic accidents

    African Journals Online (AJOL)

    bbshehu

    December, 2002, was undertaken to determine the incidence, type of injury and pregnancy outcome. Results: One hundred and forty nine women ... road traffic accidents.6 Pregnant mothers could also be involved in road traffic accident.6 ... use of helmet lowers the risk of traumatic brain injury. 11 and a case is made for the ...

  16. Outcome of pregnancy related acute kidney injury requiring ...

    African Journals Online (AJOL)

    Background: Pregnancy related acute kidney injury (AKI) severe enough to require dialysis is now rare in developed countries but is still a significant cause of maternal mortality in many resource constrained countries. However, there is scanty information from many sub-Saharan countries about outcomes of patient who ...

  17. Patient-reported outcome after fast-track hip arthroplasty: a prospective cohort study

    Directory of Open Access Journals (Sweden)

    Hansen Torben B

    2010-11-01

    Full Text Available Abstract Background A fast-track intervention with a short preoperative optimization period and short postoperative hospitalization has a potential for reduced convalescence and thereby a reduced need for postoperative rehabilitation. The purpose of this study was to describe patient-related outcomes, the need for additional rehabilitation after a fast-track total hip arthroplasty (THA, and the association between generic and disease specific outcomes. Methods The study consisted of 196 consecutive patients of which none received additional rehabilitation beyond an instructional exercise plan at discharge, which was adjusted at one in-patient visit. The patients filled in 3 questionnaires to measure health-related quality-of-life (HRQOL and hip specific function (EQ-5 D, SF36, and Harris Hip Score (HHS at 2 time points pre- and 2 time points postoperatively. The observed results were compared to normative population data for EQ-5 D, SF36, and HHS. Results 3-months postoperatively patients had reached a HRQOL level of 0.84 (SD, 0.14, which was similar to the population norm (P = 0.33, whereas they exceeded the population norm at 12 months postoperatively (P P P = 0.35. For HHS, patients never reached the population norm within 12 months postoperatively. Generic and disease specific outcomes were strongly associated. Conclusions If HRQOL is considered the primary outcome after THA, the need for additional postoperative rehabilitation for all THA patients following a fast-track intervention is questionable. However, a pre- or early postoperative physical intervention seems relevant if the PF of the population norm should be reached at 3 months. If disease specific outcome is considered the primary outcome after fast-track THA, clear goals for the rehabilitation must be established before patient selection, intervention type and timing of intervention can be made.

  18. Periodontal Disease and Pregnancy Outcomes: Time to Move On?

    OpenAIRE

    Srinivas, Sindhu K.; Parry, Samuel

    2012-01-01

    Maternal periodontal disease is a highly prevalent condition that has been studied extensively in relation to adverse pregnancy outcomes, including preterm delivery, preeclampsia, and low birth weight. Investigators speculate that hematogenous transport of bacteria and/or pro-inflammatory mediators from sites of periodontal infection into the placenta, fetal membranes, and amniotic cavity induces pathological processes that lead to these adverse outcomes. Preliminary observational studies sup...

  19. The association between HIV (treatment), pregnancy serum lipid concentrations and pregnancy outcomes: a systematic review.

    Science.gov (United States)

    Harmsen, Marissa J; Browne, Joyce L; Venter, Francois; Klipstein-Grobusch, Kerstin; Rijken, Marcus J

    2017-07-11

    Observed adverse effects of antiretroviral therapy (ART) on the lipid profile could be of significance in pregnancy. This systematic review aims to summarize studies that investigated the association between HIV, ART and serum lipids during pregnancy and adverse pregnancy outcomes. A systematic search was conducted in five electronic databases to obtain articles that measured serum lipid concentrations or the incidence of dyslipidaemia in HIV-infected pregnant women. Included articles were assessed for quality according to the Cochrane Risk of Bias Tool. The extracted data was analysed through descriptive analysis. Of the 1264 articles screened, 17 articles were included in this review; eleven reported the incidence of dyslipidaemia, and twelve on maternal serum lipid concentrations under the influence of HIV-infection and ART. No articles reported pregnancy outcomes in relation to serum lipids. Articles were of acceptable quality, but heterogenic in methods and study design. Lipid levels in HIV-infected women increased 1.5-3 fold over the trimesters of pregnancy, and remained within the physiological reference range. The percentage of women with dyslipidaemia was variable between the studies [0-88.9%] and highest in the groups on first generation protease inhibitors and for women on ART at conception. This systematic review observed physiologic concentrations of serum lipids for HIV-infected women receiving ART during pregnancy. Serum lipids were increased in users of first generation protease inhibitors and for those on treatment at conception. There was no information available about pregnancy outcomes. Future studies are needed which include HIV-uninfected control groups, control for potential confounders, and overcome limitations associated with included studies.

  20. Importance ratings on patient-reported outcome items for survivorship care: comparison between pediatric cancer survivors, parents, and clinicians.

    Science.gov (United States)

    Jones, Conor M; Baker, Justin N; Keesey, Rachel M; Eliason, Ruth J; Lanctot, Jennifer Q; Clegg, Jennifer L; Mandrell, Belinda N; Ness, Kirsten K; Krull, Kevin R; Srivastava, Deokumar; Forrest, Christopher B; Hudson, Melissa M; Robison, Leslie L; Huang, I-Chan

    2018-04-18

    To compare importance ratings of patient-reported outcomes (PROs) items from the viewpoints of childhood cancer survivors, parents, and clinicians for further developing short-forms to use in survivorship care. 101 cancer survivors, 101 their parents, and 36 clinicians were recruited from St. Jude Children's Research Hospital. Participants were asked to select eight items that they deemed useful for clinical decision making from each of the four Patient-Reported Outcomes Measurement Information System Pediatric item banks. These item banks were pain interference (20 items), fatigue (23 items), psychological stress (19 items), and positive affect (37 items). Compared to survivors, clinicians rated more items across four domains that were statistically different than did parents (23 vs. 13 items). Clinicians rated five items in pain interference domain (ORs 2.33-6.01; p's important but rated three items in psychological stress domain (ORs 0.14-0.42; p's important than did survivors. In contrast, parents rated seven items in positive affect domain (ORs 0.25-0.47; p's important than did survivors. Survivors, parents, and clinicians viewed importance of PRO items for survivorship care differently. These perspectives should be used to assist the development of PROs tools.

  1. 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

  2. Outcome of pregnancy and disease course among women with aplastic anemia treated with immunosuppression

    OpenAIRE

    MCCANN, SHAUN

    2002-01-01

    PUBLISHED Background: Aplastic anemia may develop during pregnancy and sometimes improves spontaneously after delivery. The effects of pregnancy on aplastic anemia after immunosuppressive treatment and of aplastic anemia on the outcome of pregnancy have not been described. Objective: To determine the outcome of pregnancy and the disease course among women with aplastic anemia who received immunosuppressive therapy. Design: Retrospective multicenter study. Setting: Twelve cen...

  3. Patient perspective workshop: moving towards OMERACT guidelines for choosing or developing instruments to measure patient-reported outcomes.

    Science.gov (United States)

    Kirwan, John R; Fries, James F; Hewlett, Sarah E; Osborne, Richard H; Newman, Stanton; Ciciriello, Sabina; van de Laar, Mart A; Dures, Emma; Minnock, Patricia; Heiberg, Turid; Sanderson, Tessa C; Flurey, Caroline A; Leong, Amy L; Montie, Pamela; Richards, Pam

    2011-08-01

    The workshop Choosing or Developing Instruments held at the Outcome Measures in Rheumatology (OMERACT) 10 meeting was designed to help participants think about the underlying methods of instrument development. Conference pre-reading material and 3 brief introductory presentations elaborated the issues, and participants broke into discussion groups before reconvening to share insights, engage in a more general discussion of the issues, and vote on recommendations. Tradeoffs between using current imperfect measures and the long and complex process of developing new instruments were considered, together with the need for rigor in patient-reported outcome (PRO) instrument development. The main considerations for PRO instrument development were listed and a research agenda for action produced. As part of the agenda for action, it is recommended that researchers and patient partners work together to tackle these issues, and that OMERACT bring forward proposals for acceptable instrument development protocols that would meet an enhanced "Truth" statement in the OMERACT Filter.

  4. 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...

  5. Maternal cerebrovascular accidents in pregnancy: incidence and outcomes.

    Science.gov (United States)

    Walsh, Jennifer; Murphy, Cliona; Murray, Aoife; O'Laoide, Risteard; McAuliffe, Fionnuala M

    2010-12-01

    Stroke occurring during pregnancy and the postnatal period is a rare but potentially catastrophic event. The aim of this study was to examine the incidence and outcomes of pregnancies complicated by maternal stroke in a single centre. This is a prospective study of over 35,000 consecutive pregnancies over a four-year period at the National Maternity Hospital in Dublin from 2004 to 2008; in addition we also retrospectively examined all cases of maternal mortality at our institution over a 50-year period from 1959 to 2009. We prospectively identified eight cases of strokes complicating pregnancy and the postnatal period giving an overall incidence of 22.34 per 100,000 pregnancies or 24.74 per 100,000 deliveries. There were no stroke-related mortalities during that time. Retrospective analysis of maternal mortality revealed 102 maternal deaths over a 50-year period, 19 (18.6%) of which were due to cerebrovascular accidents. In conclusion, strokes complicating pregnancy and the puerperium remain a rare event and though there appears to be evidence that the incidence is increasing, the associated maternal mortality appears to be falling.

  6. Stereotactic Body Radiation Therapy for Prostate Cancer: What is the Appropriate Patient-Reported Outcome for Clinical Trial Design?

    Directory of Open Access Journals (Sweden)

    Jennifer Ai-Lian Woo

    2015-03-01

    Full Text Available Purpose: Stereotactic body radiation therapy (SBRT is increasingly utilized as primary treatment for clinically localized prostate cancer. Consensus regarding the appropriate patient-reported outcome (PRO endpoints for clinical trials for early stage prostate cancer RT is lacking. To aid in trial design, this study presents PROs over 36 months following SBRT for clinically localized prostate cancer. Methods: 174 hormone-naïve patients were treated with 35-36.25 Gy SBRT in 5 fractions. Patients completed the EPIC-26 questionnaire at baseline and all follow-ups; the proportion of patients developing a clinically significant decline in each EPIC domain was determined. The minimally important difference (MID was defined as a change of one-half SD from the baseline. Per RTOG 0938, we examined the percentage of patients who reported decline in EPIC urinary summary score of >2 points and EPIC bowel summary score of >5 points from baseline to one year. Results: 174 patients received SBRT with minimum follow-up of 36 months. The proportion of patients reporting a clinically significant decline in EPIC urinary/bowel scores was 34%/30%, 40%/32.2%, and 32.8%/21.5% at 6, 12, and 36 months. The percentage of patients reporting decline in the EPIC urinary summary score of >2 points was 43.2%, 51.6% and 41.8% at 6, 12, and 36 months. The percentage of patients reporting decline in EPIC bowel domain summary score of >5 points was 29.6% 29% and 22.4% at 6, 12, and 36 months. Conclusion: Our treatment protocol meets the RTOG 0938 criteria for advancing to a Phase III trial compared to conventionally fractionated RT. Between 12-36 months, the proportion of patients reporting decrease in both EPIC urinary and bowel scores declined, suggesting late improvement in these domains. Further investigation is needed to elucidate 1 which domains bear the greatest influence on post-treatment QOL, and 2 at what time point PRO endpoint(s should be assessed.

  7. Anti-prothrombin antibodies are associated with adverse pregnancy outcome.

    Science.gov (United States)

    Marozio, Luca; Curti, Antonella; Botta, Giovanni; Canuto, Emilie M; Salton, Loredana; Tavella, Anna Maria; Benedetto, Chiara

    2011-11-01

    Women with antiphospholipid antibodies (aPL) such as lupus anticoagulant, anticardiolipin antibodies, and anti-β(2) glycoprotein-1 antibodies are at high risk of late pregnancy complications, such as severe pre-eclampsia, placental insufficiency, and fetal loss. It has been observed that aPL consists of a heterogeneous group of antibodies targeting several phospholipid-binding plasma proteins, including also anti-prothrombin (anti-PT), anti-protein S (anti-PS), and anti-protein C (anti-PC) antibodies. Their potential role in late pregnancy complications is not known. The aim of this work was to investigate the association between those autoantibodies and histories for adverse pregnancy outcome. Anti-PT, anti-PS, and anti-PC antibodies were evaluated in 163 patients with previous severe pre-eclampsia, fetal death, and/or placental abruption and in as many women with previous uneventful pregnancies, negative for aPL. The prevalence of anti-PT antibodies was higher in cases than in controls (OR, 95% CI: 10.92, 4.52-26.38). The highest prevalence was observed in subjects with fetal death. Anti-PT antibodies appear to be associated with adverse pregnancy outcome, irrespectively of aPL. © 2011 John Wiley & Sons A/S.

  8. Thrombocytopenia during Pregnancy and Its Outcome – A Prospective Study

    Directory of Open Access Journals (Sweden)

    Pallavi Satish Vishwekar

    2017-01-01

    Full Text Available Background: Thrombocytopenia is second to anemia as the most common hematological abnormality during pregnancy. Accurate etiological diagnosis is essential for optimal therapeutic management and thus can prevent maternal and fetal morbidity and mortality. Aims and Objectives: To determine various etiologies of maternal thrombocytopenia, their complications and fetomaternal outcome compared with normal pregnancy. Material and Methods: A prospective study was carried out in tertiary hospital, 1460 pregnant women who attended the Antenatal clinic regularly were enrolled. All were screened for thrombocytopenia in third trimester (after 28 weeks, women with normal platelet (n=1350 were taken in control group and those with low counts less than 150 x109/L (n=130 were included in study group. Etiology and fetomaternal outcome of thrombocytopenia in third trimester of pregnancy were evaluated and compared. Results: Gestational thrombocytopenia was the commonest etiology (68.46%. Incidence of thrombocytopenia due to severe preeclampsia and Hemolysis, Elevated Liver enzymes, Low Platelet (HELLP syndrome in study group was 18.46% and 7.69% of them had medical cause like malarial or dengue fever. Major causes were Gestational Thrombocytopenia (GT, Idiopathic Thrombocytopenic Purpura (ITP, preeclampsia, HELLP syndrome, malaria, and dengue. Maternal complications due to bleeding tendencies like placental abruption, postpartum hemorrhage were evident in the study population. Fetal complications were significantly higher in study group. Early neonatal thrombocytopenia depended on etiology rather than severity of maternal thrombocytopenia. Conclusions: Outcome of pregnancy with moderate to severe thrombocytopenia depends mainly on the etiology of thrombocytopenia. Adverse outcomes are especially seen with pregnancy complicated by preeclampsia and HELLP syndrome. Fetomaternal outcome is favorable in gestational thrombocytopenia. Thus accurate etiological

  9. Clinical audit of foetomaternal outcome in pregnancies with fibroid uterus

    International Nuclear Information System (INIS)

    Sarwar, I.; Habib, S.; Bibi, A.; Malik, N.; Parveen, Z.

    2012-01-01

    Background: Leiomyoma, myoma, leiomyoma or fibroids are synonymous terms. They may be present in as many as 1 in 5 women over age 35 years. If pregnancy is associated with fibroids, it leads to multiple complications. Objectives of this study were to evaluate the maternal and foetal outcome in women having pregnancy with fibroids in uterus and the complications associated with fibroids during the pregnancy. Methods: This descriptive study was conducted in the Department of Obstetrics and Gynaecology, Ayub Teaching Hospital Abbottabad from March 2009 to March 2010. Data were collected on proforma regarding demographic variables, obstetrical history, mode of delivery, maternal outcome, maternal complications, and foetal outcome. Mean and standard deviation was calculated for age, period of gestation, and obstetrical history. Frequency and percentages was calculated for booking status, maternal outcome, maternal complications and foetal outcome. Results: Thirty patients were included in this study who had pregnancy with fibroid. Normal delivery was achieved in 14 (46.66%) patients. Eight (26.67%) patients had caesarean section and eight (26.67%) had miscarriages. Seven (23.33%) patients had no complications while 8 (26.67%) had miscarriages, 8 (26.67%) had postpartum haemorrhage, 10 (33.33%) had preterm delivery, and 3 patients had ante-partum haemorrhage. Two (10%) patients had premature rupture off membranes and 1 patient (3.33%) had pain abdomen and technical difficulty during caesarean section. There were 12 (40%) healthy babies. Five (16.67%) babies delivered with morbidity but recovered. There were 4 (13.33%) intrauterine deaths and one early neonatal death. Conclusion: Fibroid in pregnancy, especially multiple intramural fibroids and fibroids larger than 10 Cm, cause miscarriage and preterm labour. (author)

  10. Use of the Derriford Appearance Scale 59 to assess patient-reported outcomes in secondary cleft surgery.

    Science.gov (United States)

    Ricketts, Sophie; Regev, Eran; Antonyshyn, Oleh M; Kiss, Alex; Fialkov, Jeffrey A

    2016-01-01

    Secondary rhinoplasty, one of the final procedures in addressing the stigma of the cleft lip and palate (CLP), has both functional and aesthetic objectives. The way in which physicians evaluate outcomes in surgery concerning aesthetics is changing. Well-designed patient-reported outcome measures to assess health-related quality of life improvements attributable to surgery are increasingly being used. The Derriford Appearance Scale 59 (DAS-59) is currently the only available validated patient-reported outcome measure that assesses concern about physical appearance. Twenty patients with CLP presenting between May 2009 and May 2013 for secondary rhinoplasty to Sunnybrook Health Sciences Centre (Toronto, Ontario) were recruited. DAS-59 measures were administered both preoperatively and at least six months after surgery. Pre- and postoperative measures were scored and compared. Item-by-item analysis of the measure was also performed. Total scores for this CLP group indicated greater concern about appearance than the general population. Across all subscales of the measure, there was a reduction in scores after secondary rhinoplasty suggesting less patient concern with appearance and a positive effect of surgery on patient quality of life. Item-by-item analysis suggested relatively few items in the measure were driving overall change in total scores. Comparison of pre- and postoperative scores with the DAS-59 in secondary cleft rhinoplasty suggests there is less concern with appearance after surgery. However, a small number of items within this generic scale contributing to this difference may suggest the need for a more patient specific measure for assessment of surgical outcomes in the cleft population.

  11. Teen Pregnancy: Are Pregnancies following an Elective Termination Associated with Increased Risk for Adverse Perinatal Outcomes?

    Science.gov (United States)

    van Veen, Teelkien R; Haeri, Sina; Baker, Arthur M

    2015-12-01

    The authors sought to determine whether pregnancies in adolescents following an abortion of pregnancy is associated with an elevated risk for adverse perinatal outcomes. In a cohort study of all adolescent (younger than 18 years) deliveries over a 4-year period at 1 institution, we compared nulliparous women with a history of a prior abortion (cases) to those without a spontaneous loss or abortion of pregnancy (referent) for adverse perinatal outcomes, including preterm birth and fetal growth restriction. Of the 654 included nulliparous adolescent deliveries, 102 (16%) had an abortion before the index pregnancy. Compared with the referent group, adolescents with a history of a abortion were older (17.8 ± 0.8 vs 16.7 ± 1.2 years, P = .0001), enrolled earlier for prenatal care (14.4 ± 5.6 vs 17.2 ± 7.6 weeks, P = .0004), along with a higher incidence of African American race (95% vs 88%, P = .05). The groups did not differ with respect to other maternal demographics. Perinatal outcomes, including spontaneous preterm birth, abnormal placentation, birth weight, and gestational age at delivery, did not differ between the 2 groups. Compared with adolescent women who had just delivered and did not have a prior abortion, women who had just delivered and had a previous abortion were more likely to be older at the age of their first pregnancy and more likely to initiate early prenatal care. Thus, having a prior abortion may improve the health of a pregnancy though adverse outcomes do not differ between the 2 groups. Copyright © 2015 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

  12. Prenatal lignan exposures, pregnancy urine estrogen profiles and birth outcomes

    International Nuclear Information System (INIS)

    Tang, Rong; Chen, Minjian; Zhou, Kun; Chen, Daozhen; Yu, Jing; Hu, Weiyue; Song, Ling; Hang, Bo; Wang, Xinru; Xia, Yankai

    2015-01-01

    During pregnancy, human exposure to endogenous estrogens and xenoestrogens (such as lignans) may comprehensively impact the gestational maintenance and fetal growth. We measured the concentrations of 5 lignans and the profile of 13 estrogen metabolites (EMs) in the urine samples of 328 pregnant women and examined their associations with birth outcomes. We found significantly positive associations between gestational age and urinary matairesinol (MAT), enterodiol (END) and enterolactone (ENL), as well as 16-hydroxylation pathway EMs. There were consistently positive relationships between END and the 16-hydroxylation pathway EMs. The positive relationships of MAT, END and ENL exposures with the length of gestation were mainly in the low exposure strata of the levels of these EMs. This study reveals that MAT, END and ENL as well as 16-hydroxylation pathway EMs are associated with birth outcomes, and that there are interactive relationships between lignans and 16-hydroxylation pathway EMs with birth outcomes. - Highlights: • We examined relations between prenatal lignan exposures and birth outcomes. • We examined relations between pregnancy urine estrogen profiles and birth outcomes. • MAT, END and ENL are associated with birth outcomes. • 16-hydroxylation pathway EMs are associated with birth outcomes. • There are interactive relationships between ligans and EMs with birth outcomes. - Prenatal lignan exposures and EM levels were interactively related to birth outcomes

  13. Inappropriate gestational weight gain among teenage pregnancies: prevalence and pregnancy outcomes.

    Science.gov (United States)

    Vivatkusol, Yada; Thavaramara, Thaovalai; Phaloprakarn, Chadakarn

    2017-01-01

    To study the prevalence and pregnancy outcomes of inappropriate gestational weight gain (GWG) among teenage pregnant women. A retrospective descriptive study was conducted on 2,165 teenage pregnant women who attended our antenatal clinic between January 2007 and August 2015. Adverse pregnancy outcomes, including maternal and neonatal outcomes of women with inappropriate GWG, including underweight and overweight, were studied and compared with those of women with appropriate GWG. Complete data of 1,943 women were obtained. Among these women, the mean age was 17.4±1.4 years and mean body mass index at first visit was 19.1±3.0 kg/m 2 . The prevalence of inappropriate GWG was 61.7%. Underweight women were more likely to experience anemia and preterm delivery, whereas overweight women required more cesarean sections because of cephalopelvic disproportion and preeclampsia, compared to women with appropriate weight gain (all P teenage pregnancies showed inappropriate GWG. GWG had a significant impact on pregnancy outcomes.

  14. Oncological Management and Pregnancy Outcomes in Women Diagnosed With Cancer During Pregnancy

    DEFF Research Database (Denmark)

    Verheecke, Magali; Van Calsteren, Kristel; Fruscio, Robert

    2017-01-01

    Aims The effect of the increased awareness of the potential to treat cancer during pregnancy is currently unknown. Therefore we aimed to analyse the oncological management and the obstetrical and neonatal outcomes of patients treated in the last 20 years by members of the International Network...

  15. Association between Intimate Partner Violence during Pregnancy and Adverse Pregnancy Outcomes in Vietnam

    DEFF Research Database (Denmark)

    Thanh Nguyen Hoang; Toan Ngo Van; Gammeltoft, Tine

    2016-01-01

    Background: Violence against pregnant women is an increasing public health concern particularly in low- and middle-income countries. The purpose of this study was to measure the association between intimate partner violence (IPV) during pregnancy and the risk of adverse birth outcomes. Methods: P...

  16. OUTCOME OF PREGNANCIES COMPLICATED BY THREATENED ABORTION IN THE SECOND TRIMESTER OF PREGNANCY - PROSPECTIVE STUDY

    OpenAIRE

    Rajeswary

    2015-01-01

    AIM: To compare the outcome of pregnancies complicated by bleeding per vaginum between 14- 20 weeks with those not complicated by bleeding per vaginum before 20 weeks. To evaluate the potential determinants of outcome such as gestational age at bleeding, number of bleeding episodes, extent of placental separation or sub chorionic bleed, incidence of complications as placenta previa, abruptio placenta, development of gestational hypertension and pre eclampsia, intra uterine gro...

  17. Patient-reported allergies cause inferior outcomes after total knee arthroplasty.

    Science.gov (United States)

    Hinarejos, Pedro; Ferrer, Tulia; Leal, Joan; Torres-Claramunt, Raul; Sánchez-Soler, Juan; Monllau, Joan Carles

    2016-10-01

    The main objective of this study was to analyse the outcomes after total knee arthroplasty (TKA) of a group of patients with at least one self-reported allergy and a group of patients without reported allergies. We hypothesized there is a significant negative influence on clinical outcome scores after TKA in patients with self-reported allergies. Four-hundred and seventy-five patients who had undergone TKA were analysed preoperatively and 1 year after surgery. The WOMAC, KSS and SF-36 scores were obtained. The patients' Yesavage depression questionnaire score was also recorded. The scores of the 330 (69.5 %) patients without self-reported allergies were compared to the scores of the 145 (30.5 %) patients with at least one self-reported allergy in the medical record. Preoperative scores were similar in both groups. The WOMAC post-operative scores (23.6 vs 20.4; p = 0.037) and the KSS-Knee score (91.1 vs 87.6; p = 0.027) were worse in the group of patients with self-reported allergies than in the group without allergies. The scores from the Yesavage depression questionnaire and in the SF-36 were similar in both groups. Patients with at least one self-reported allergy have worse post-operative outcomes in terms of the WOMAC and KSS-Knee scores after TKA than patients without allergies. These poor outcomes do not seem to be related to depression. Therefore, more research is needed to explain them. Reported allergies could be considered a prognostic factor and used when counselling TKA patients. I.

  18. Assessing Patient-Reported Outcomes Following Orthognathic Surgery and Osseous Genioplasty.

    Science.gov (United States)

    Schwitzer, Jonathan A; Albino, Frank P; Mathis, Ryan K; Scott, Amie M; Gamble, Laurie; Baker, Stephen B

    2015-11-01

    Primary outcomes for orthognathic surgery and genioplasty patients include satisfaction with appearance, improved motor function, and enhanced quality of life. The goal of this study was to assess outcomes among patients undergoing these procedures, and to highlight the potential use of FACE-Q instrument for use in patients with dentofacial deformities. A total of 56 patients presenting for orthognathic surgery and/or osseous genioplasty completed the FACE-Q during preoperative and/or at postoperative visits. FACE-Q scores increased following surgery in satisfaction with facial appearance overall (+24.5, P jawline (+40.7, P < 0.01), and in all satisfaction with chin items (profile, prominence, shape, and overall). Patients also demonstrated increased social confidence (+8.9, P = 0.29). There was no improvement in psychologic well-being (-0.8, P = 0.92). All 3 surgical groups of patients experienced gains in satisfaction with appearance following surgery. Patients who underwent orthognathic surgery either alone or in combination with genioplasty demonstrated statistically significant improvements in satisfaction with facial appearance overall (P < 0.01 for both groups), whereas patients who underwent genioplasty alone did not (P = 0.13). In addition, patients who underwent orthognathic surgery combined with genioplasty demonstrated greater improvement in satisfaction with chin than patients who underwent genioplasty alone. In conclusion, patients who underwent orthognathic surgery and/or genioplasty demonstrated improvement in appearance and social confidence. The use of this model supports the successful outcomes possible for patients undergoing these procedures.

  19. Examining the Minimal Important Difference of Patient-reported Outcome Measures for Individuals with Knee Osteoarthritis

    DEFF Research Database (Denmark)

    Mills, Kathryn A G; Naylor, Justine M; Eyles, Jillian P

    2016-01-01

    injury and Osteoarthritis Outcome Score (KOOS). METHODS: Retrospective analysis of prospectively collected data from 272 patients with knee OA undergoing a multidisciplinary nonsurgical management strategy. The magnitude and rate of change as well as the influence of baseline covariates were examined...... for 5 KOOS subscales over 52 weeks. The MID for improving and worsening were investigated using 4 anchor-based methods. RESULTS: Waitlisted for joint replacement and exhibiting unilateral/bilateral symptoms influenced change in KOOS over time. Generally, low correlations between anchors and KOOS change...

  20. Informative value of Patient Reported Outcomes (PRO in Health Technology Assessment (HTA

    Directory of Open Access Journals (Sweden)

    Brettschneider, Christian

    2011-01-01

    Full Text Available Background: “Patient-Reported Outcome” (PRO is used as an umbrella term for different concepts for measuring subjectively perceived health status e. g. as treatment effects. Their common characteristic is, that the appraisal of the health status is reported by the patient himself. In order to describe the informative value of PRO in Health Technology Assessment (HTA first an overview of concepts, classifications and methods of measurement is given. The overview is complemented by an empirical analysis of clinical trials and HTA-reports on rheumatoid arthritis and breast cancer in order to report on type, frequency and consequences of PRO used in these documents. Methods: For both issues systematic reviews of the literature have been performed. The search for methodological literature covers the publication period from 1990 to 2009, the search for clinical trials of rheumatoid arthritis and breast cancer covers the period 2005 to 2009. Both searches were performed in the medical databases of the German Institute of Medical Documentation and Information (DIMDI. The search for HTA-reports and methodological papers of HTA-agencies was performed in the CRD-Databases (CRD = Centre for Reviews and Dissemination and by handsearching the websites of INAHTA member agencies (INAHTA = International Network of Agencies for Health Technology Assessment. For all issues specific inclusion and exclusion criteria were defined. The methodological quality of randomized controlled trials (RCT was assessed by a modified version of the Cochrane Risk of Bias Tool. For the methodological part information extraction from the literature is structured by the report’s chapters, for the empirical part data extraction sheets were constructed. All information is summarized in a qualitative manner. Results: Concerning the methodological issues the literature search retrieved 158 documents (87 documents related to definition or classification, 125 documents related to

  1. 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.

  2. Refractive lens exchange in younger and older presbyopes: comparison of complication rates, 3 months clinical and patient-reported outcomes.

    Science.gov (United States)

    Schallhorn, Steven C; Schallhorn, Julie M; Pelouskova, Martina; Venter, Jan A; Hettinger, Keith A; Hannan, Stephen J; Teenan, David

    2017-01-01

    To compare refractive and visual outcomes, patient satisfaction, and complication rates among different age categories of patients who underwent refractive lens exchange (RLE). A stratified, simple random sample of patients matched on preoperative sphere and cylinder was selected for four age categories: 45-49 years (group A), 50-54 years (group B), 55-59 years (group C), and 60-65 years (group D). Each group contained 320 patients. All patients underwent RLE with a multifocal intraocular lens at least in one eye. Three months postoperative refractive/visual and patient-reported outcomes are presented. The percentage of patients that achieved binocular uncorrected distance visual acuity 20/20 or better was 91.6% (group A), 93.8% (group B), 91.6% (group C), 88.8% (group D), P =0.16. Binocularly, 80.0% of patients in group A, 84.7% in group B, 78.9% in group C, and 77.8% in group D achieved 20/30 or better uncorrected near visual acuity ( P =0.13). The proportion of eyes within 0.50 D of emmetropia was 84.4% in group A, 86.8% in group B, 85.7% in group C, and 85.8% in group D ( P =0.67). There was no statistically significant difference in postoperative satisfaction, visual phenomena, dry eye symptoms, distance or near vision activities. Apart from higher rate of iritis in the age group 50-55 years, there was no statistically significant difference in postoperative complication rates. RLE can be safely performed in younger as well as older presbyopes. No significant difference was found in clinical or patient-reported outcomes.

  3. Outcome of Teenage Pregnancy at a Tertiary Hospital in Abakaliki ...

    African Journals Online (AJOL)

    Background: Teenage pregnancy is a high risk pregnancy associated with obstetric ... These complications are worsened by poverty, ignorance and lack of special ... higher risk of anemia in pregnancy, HIV in pregnancy, malaria in pregnancy, ...

  4. Reported outcomes of 453 pregnancies in patients with Gaucher disease: An analysis from the Gaucher outcome survey.

    Science.gov (United States)

    Lau, Heather; Belmatoug, Nadia; Deegan, Patrick; Goker-Alpan, Ozlem; Schwartz, Ida Vanessa D; Shankar, Suma P; Panahloo, Zoya; Zimran, Ari

    2018-02-01

    Gaucher disease (GD) may worsen during pregnancy, leading to the discussion of continuing treatment during pregnancy. We examined fetal outcomes of pregnancies reported in the Gaucher Outcome Survey, an international GD-specific registry established in 2010. A total of 453 pregnancies were reported. Most pregnancies (336/453, 74.2%) were in women who did not receive GD-specific treatment during pregnancy, while enzyme replacement therapy (ERT) was received during 117/453 (25.8%) pregnancies. No pregnancies exposed to substrate reduction therapy were reported. The percentage of normal outcomes (live birth delivered at term with no congenital abnormalities) was similar in untreated and treated pregnancies (92.9% vs. 91.4%). The percentage of spontaneous abortions in untreated pregnancies was 3.6% (95% CI, 1.9%- 6.2%) compared with 6.9% (95% CI, 3.0%-13.1%) in treated pregnancies (p=0.1866). In women who received velaglucerase alfa <1month prior to conception and/or during pregnancy, 34/36 (94.4%) pregnancies had normal outcomes and 2 (5.6%) ended in spontaneous abortion. Normal outcomes were observed in the 20 pregnancies with velaglucerase alfa exposure starting <1month prior to conception and continuing through all trimesters. These observations, in addition to information in the literature, suggest that continuation of ERT during pregnancy may be appropriate for GD patients. Copyright © 2016 Shire Human Genetic Therapies, Inc. Published by Elsevier Inc. All rights reserved.

  5. Mycoplasma, Ureaplasma, and Adverse Pregnancy Outcomes: A Fresh Look

    Directory of Open Access Journals (Sweden)

    Bryan Larsen

    2010-01-01

    Full Text Available Recent work on the Molicutes that associate with genital tract tissues focuses on four species that may be of interest in potential maternal, fetal, and neonatal infection and in contributing to adverse pregnancy outcomes. Mycoplasma hominis and Ureaplasma urealyticum have historically been the subject of attention, but Mycoplasma genitalis which causes male urethritis in addition to colonizing the female genital tract and the division of Ureaplasma into two species, urealyticum and parvum, has also added new taxonomic clarity. The role of these genital tract inhabitants in infection during pregnancy and their ability to invade and infect placental and fetal tissue is discussed. In particular, the role of some of these organisms in prematurity may be mechanistically related to their ability to induce inflammatory cytokines, thereby triggering pathways leading to preterm labor. A review of this intensifying exploration of the mycoplasmas in relation to pregnancy yields several questions which will be important to examine in future research.

  6. Patient-Reported Esthetic and Functional Outcomes of Primary Total Laparoscopic Intestinal Vaginoplasty in Transgender Women With Penoscrotal Hypoplasia.

    Science.gov (United States)

    Bouman, Mark-Bram; van der Sluis, Wouter B; van Woudenberg Hamstra, Leonora E; Buncamper, Marlon E; Kreukels, Baudewijntje P C; Meijerink, Wilhelmus J H J; Mullender, Margriet G

    2016-09-01

    Puberty-suppressing hormonal treatment may result in penoscrotal hypoplasia in transgender women, making standard penile inversion vaginoplasty not feasible. For these patients, intestinal vaginoplasty is a surgical alternative, but knowledge on patient-reported postoperative outcomes and quality of life is lacking. To assess patient-reported functional and esthetic outcomes, quality of life, satisfaction, and sexual well-being after primary total laparoscopic intestinal vaginoplasty in transgender women. A survey study was performed on transgender women who underwent primary total laparoscopic intestinal vaginoplasty with at least 1 year of clinical follow-up. Thirty-one transgender women completed the questionnaires (median age at time of surgery = 19.1 years, range = 18.3-45.0) after a median clinical follow-up of 2.2 years (range = 0.8-7.5). Consenting women were asked to complete a combined questionnaire of the Subjective Happiness Scale, the Satisfaction With Life Scale, Cantril's Ladder of Life Scale, the Female Sexual Function Index, the Female Genital Self-Imaging Scale, the Amsterdam Hyperactive Pelvic Floor Scale-Women, and a questionnaire addressing postoperative satisfaction. Patient-reported functional and esthetic outcomes and postoperative quality of life. Patients graded their life satisfaction a median of 8.0 (range = 4.0-10.0) on Cantril's Ladder of Life Scale. Patients scored a mean total score of 27.7 ± 5.8 on the Satisfaction With Life Scale, which indicated high satisfaction with life, and a mean total score of 5.6 ± 1.4 on the Subjective Happiness Scale. Functionality was graded a median score of 8.0 of 10 (range = 1.0-10.0) and esthetics a score of 8.0 out of 10 (range = 3.0-10.0). The mean Female Sexual Function Index total score of sexually active transgender women was 26.0 ± 6.8. This group of relatively young transgender women reported satisfactory functional and esthetic results of the neovagina and a good quality of life

  7. On-demand Modafinil Improves Ejaculation Time and Patient-reported Outcomes in Men With Lifelong Premature Ejaculation.

    Science.gov (United States)

    Tuken, Murat; Kiremit, Murat Can; Serefoglu, Ege Can

    2016-08-01

    To evaluate the effects of modafinil on the intravaginal ejaculatory latency time (IELT) and patient-reported outcomes in patients with lifelong premature ejaculation (PE). Treatment-naïve lifelong PE patients were included in this proof-of-concept study. Self-estimated IELTs of the patients were recorded and the Premature Ejaculation Profile (PEP) questionnaire was administered before the initiation of on-demand modafinil 100 mg treatment. At the end of 1 month of treatment, self-estimated IELTs were recorded again, along with posttreatment PEP outcomes. Overall, 55 lifelong PE patients with a mean age of 35.07 ± 7.80 (range: 22-58) years were enrolled. Modafinil treatment modestly increased the mean IELT at the end of 1 month (24.82 ± 16.10 seconds vs 49.82 ± 31.46 seconds, P = .0001). Moreover, at the end of 1 month, patients reported in the PEP questionnaire better control over ejaculation (0.75 ± 0.67 vs 1.35 ± 0.91, P = .0001), improved satisfaction with sexual intercourse (0.98 ± 0.78 vs 1.40 ± 0.85, P = .0001), lesser personal distress (0.42 ± 0.69 vs 0.89 ± 1.01, P = .0001), and reduced interpersonal difficulty (1.69 ± 1.48 vs 1.95 ± 1.47, P = .0001). In an uncontrolled proof-of-concept study of men with treatment-naïve lifelong PE where IELT was self-reported without a stopwatch, modest improvements of both IELT and patient-reported outcome measures were observed. Future controlled clinical trials are necessary to confirm these findings. Copyright © 2016 Elsevier Inc. All rights reserved.

  8. 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

  9. Racial and ethnic variations in one-year clinical and patient-reported outcomes following breast reconstruction.

    Science.gov (United States)

    Berlin, Nicholas L; Momoh, Adeyiza O; Qi, Ji; Hamill, Jennifer B; Kim, Hyungjin M; Pusic, Andrea L; Wilkins, Edwin G

    2017-08-01

    Existing studies evaluating racial and ethnic disparities focus on describing differences in procedure type and the proportion of women who undergo reconstruction following mastectomy. This study seeks to examine racial and ethnic variations in clinical and patient-reported outcomes (PROs) following breast reconstruction. The Mastectomy Reconstruction Outcomes Consortium is an 11 center, prospective cohort study collecting clinical and PROs following autologous and implant-based breast reconstruction. Mixed-effects regression models, weighted to adjust for non-response, were performed to evaluate outcomes at one-year postoperatively. The cohort included 2703 women who underwent breast reconstruction. In multivariable models, Hispanic or Latina patients were less likely to experience any complications and major complications. Black or African-American women reported greater improvements in psychosocial and sexual well-being. Despite differences in pertinent clinical and socioeconomic variables, racial and ethnic minorities experienced equivalent or better outcomes. These findings provide reassurance in the context of numerous racial and ethnic health disparities and build upon our understanding of the delivery of surgical care to women with or at risk for developing breast cancer. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. Pregnancy outcome in undiagnosed gestational diabetes

    International Nuclear Information System (INIS)

    Dehdashtian, M.; Aletayeb, S.M.H.; Kajbaf, T.Z.; Taheri, M.; Aminzadeh, M.

    2012-01-01

    Objective: To investigate the outcomes of macrosomia and compare the risk factors associated with neonatal and maternal complications between mothers with gestational diabetes (GDM) and Non-GDM mothers, and determine whether it is important to screen for GDM before birth. Methodology: We sampled the venous blood of the mothers of 120 macrosomic neonates in the was based on a HbA1c>5.9%. Results: Twenty-three (19%) mothers had an HgbA1c>5.9%. Maternal and neonatal complications mother's age, parity, and BMI, other risk factors for the development of GDM didn't differ significantly between the two groups. Conclusions: The frequency of neonatal and maternal complications associated with the birth macrosonic neonates are significantly different between GDM and non-GDM mothers. Hence, of the universal screening of pregnant women for GDM is not recommended. (author)

  11. Muscle function is associated with future patient-reported outcomes in young adults with ACL injury

    DEFF Research Database (Denmark)

    Flosadottir, Vala; Roos, Ewa M; Ageberg, Eva

    2016-01-01

    performance and worse postural orientation were associated with worse KOOS scores 2 years later (rsp≥0.280, p≤0.045). Worse muscle power was associated with lower future ARS scores (rsp=0.281, p=0.044). CONCLUSIONS: The moderate associations suggest that improving muscle function during rehabilitation could...... and postural orientation 3 years (SD 0.85) after ACL injury. PROs at 3 and 5 years after injury included Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales Function in sport and recreation (KOOS Sport/rec) and Knee-related Quality of life (KOOS QoL), KOOS item Q3 (KOOS Q3), Tegner Activity Scale...... improve present and future PROs....

  12. Impact of rituximab on patient-reported outcomes in patients with rheumatoid arthritis from the US Corrona Registry.

    Science.gov (United States)

    Harrold, Leslie R; John, Ani; Best, Jennie; Zlotnick, Steve; Karki, Chitra; Li, YouFu; Greenberg, Jeffrey D; Kremer, Joel M

    2017-09-01

    To evaluate the impact of rituximab on patient-reported outcomes (PROs) in a US-based observational cohort of patients with rheumatoid arthritis (RA). Patients with active RA, prior exposure to ≥1 tumor necrosis factor inhibitor (TNFi) and who newly initiated rituximab were identified. Changes in PROs were assessed 1 year after rituximab initiation. PRO measures included Clinical Disease Activity Index (CDAI); patient global disease activity, pain and fatigue (visual analog score; 0-100); morning stiffness (hours); modified Health Assessment Questionnaire (mHAQ; 0-3); and EuroQoL EQ-5D. Of the 667 patients who newly initiated rituximab, baseline PRO and clinical measures indicated that patients were substantially impacted by their RA disease and quality of life; 54% of patients had high disease activity. One year after rituximab initiation, 49.0, 47.1, 49.8, and 23.2% of patients reported clinically meaningful improvements in patient global, pain, fatigue, and mHAQ, respectively. Morning stiffness and EuroQol EQ-5D domains improved in 48 and 19-32% of patients, respectively. These real-world registry data demonstrated that patients with long-standing, refractory RA experienced improvements in PROs 1 year after initiating rituximab.

  13. Inflammatory Bowel Disease and Risk of Adverse Pregnancy Outcomes

    Science.gov (United States)

    Boyd, Heather A.; Basit, Saima; Harpsøe, Maria C.; Wohlfahrt, Jan; Jess, Tine

    2015-01-01

    Background and Objectives Existing data on pregnancy complications in inflammatory bowel disease (IBD) are inconsistent. To address these inconsistencies, we investigated potential associations between IBD, IBD-related medication use during pregnancy, and pregnancy loss, pre-eclampsia, preterm delivery, Apgar score, and congenital abnormalities. Methods We conducted a cohort study in >85,000 Danish National Birth Cohort women who were pregnant in the period 1996-2002 and had information on IBD, IBD-related medication use (systemic or local corticosteroids, 5-aminosalicylates), pregnancy outcomes and potential confounders. We evaluated associations between IBD and adverse pregnancy/birth outcomes using Cox regression and log-linear binomial regression. Results IBD was strongly and significantly associated with severe pre-eclampsia, preterm premature rupture of membranes and medically indicated preterm delivery in women using systemic corticosteroids during pregnancy (hazard ratios [HRs] >7). IBD was also associated with premature preterm rupture of membranes in women using local corticosteroid medications (HR 3.30, 95% confidence interval [CI] 1.33-8.20) and with medically indicated preterm delivery (HR 1.91, 95% CI 0.99-3.68) in non-medicated women. Furthermore, IBD was associated with low 5-minute Apgar score in term infants (risk ratio [RR] 2.19, 95% CI 1.03-4.66). Finally, Crohn’s disease (but not ulcerative colitis) was associated with major congenital abnormalities in the offspring (RR 1.85, 95% CI 1.06-3.21). No child with a congenital abnormality born to a woman with IBD was exposed to systemic corticosteroids in utero. Conclusion Women with IBD are at increased risk of severe pre-eclampsia, medically indicated preterm delivery, preterm premature rupture of membranes, and delivering infants with low Apgar score and major congenital malformations. These associations are only partly explained by severe disease as reflected by systemic corticosteroid use

  14. The neonatal outcome in twin versus triplet and quadruplet pregnancies

    Directory of Open Access Journals (Sweden)

    Fatemeh Nasseri

    2009-02-01

    Full Text Available

    • BACKGROUND: To assess the risk of neonatal mortality and morbidity in twin, triplet and quadruplet pregnancies.
    • METHODS: In a retrospective study, the neonatal outcome of all twin, triplet and quadruplet gestations delivered from October 2001 to September 2006 was reviewed. The neonatal outcome of triples and quadruplets was compared with a matched group of twins for gestational age.
    • RESULTS: During a 5-year period, 511 sets of twin pregnancies, 42 sets of triplet and 5 sets of quadruplet pregnancies were studied. The mean of gestational age for twins, triplets and quadruplets were 33.92 ± 3.5 weeks, 30.92 ± 3.8 weeks and 31.60 ± 2.0 weeks, respectively, (P = 0.0001. Triplets and quadruplets weighed less than twins, (P = 0.0001. Neonatal mortality was 13.5% for twins, 26.8% for triplets and 30% for quadruplets. In vitro fertilization, use of ovulation induction agents, and cesarean delivery in the women with triplet and quadruplet were significantly higher than in those with twin pregnancies, (P = 0.0001. The mean age of mothers with triplets and quadruplets was significantly higher than with twins (P = 0.026. There was not a significant difference in respiratory and non-respiratory short outcomes between triplets, quadruplets and twins when matched for gestational age. Apgar score at 1 and 5 minutes was significantly lower in triplets and quadruplets than twins. There was no influence of birth order on neonatal mortality of triplet pregnancy. Neonatal mortality of triplet births was significantly decreased over the 5 years of the study period.
    • CONCLUSIONS: Triplets and quadruplets have a similar neonatal outcome as twins when matched for gestational age. There is no influence of birth on the neonatal mortality of triplet pregnancy. It appears that outcome is mainly dependent on gestational age.
    • KEYWORDS: Neonatal

    • 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

    • Retrospective evaluation of the pregnancy outcomes of women with epilepsy

      Directory of Open Access Journals (Sweden)

      Mert Kazandı

      2010-09-01

      Full Text Available Objective: The purpose of this study was to investigate obstetric and neonatal outcomes and to discuss benefit effects of preconception counseling of women with epilepsy. Design: Retrospective evaluation of the pregnancy outcomes of women with epilepsy, which it was diagnosed by neurologist at Department of Obstetrics and Gynecology, Ege University School of Medicine, İzmir, between january 2004 and november 2009. Data according to demographic, obstetric and neonatal variables were collected retrospectively from the records of 66 pregnants with epilepsy. We also investigated the pregnancy outcomes related to AED using and preconception counseling. Setting: Department of Obstetrics and Gynecology, Ege University School of Medicine, İzmir Patients: 66 pregnants with epilepsy. Results: The mean maternal age was 28,3±6,3. the median gestational age and fetal weight was 38±0,7 weeks and 3027±341 gr at the time of birth, respectively. Fourteen pregnants (%23,1 were borned before 37. gestational weeks. There were no adverse fetal outcomes and major or minor congenital malformations. The preconception counseling ratio was % 57,57 (n: 38 in study group and all of these used antiepileptic drugs during pregnancy. 28 (%42,43 pregnants with epilepsy didn’t applied preconception counseling that 17 cases of them discontinued their medical terapy during first trimester. Epileptic seizures were commonly developed because of leaving AED. Conclusion: The pregnants with epilepsy have some risk according to disease and medical terapy. A good team work is required by experienced obstetrician and neurologist for management. Then, favorable pregnancy outcomes may be obtained as like as general population.

    • Short-term side effects and patient-reported outcomes of bleomycin sclerotherapy in vascular malformations.

      Science.gov (United States)

      Mack, Joana M; Richter, Gresham T; Becton, David; Salem, Omar; Hill, Sarah E M; Crary, Shelley E

      2018-06-01

      Vascular malformations (VM) are congenital lesions that can be debilitating and cause significant aesthetic and functional limitations. The chemotherapeutic agent bleomycin has been utilized as a sclerosant, directly injected percutaneously into the VM. Unfortunately, little is known about the benefits and short-term side effects of bleomycin with intralesional injections. An IRB approved, retrospective chart review was performed on patients with VM who had been treated with intralesional bleomycin. Data included type of VM, number of treatments, total bleomycin dose per m², and adverse effects. A questionnaire was administered to available patients to assess subjective outcomes and side effects. Forty-six patients were treated with 141 procedures of bleomycin sclerotherapy for VM. Patient ages ranged from 1 to 20 years (median age 10 years). The median cumulative bleomycin dose was 16.3 units/m²/person (range of 1.7-97.0 units/m²/person). Sixty-three percent of patients were reached for a questionnaire to assess short-term side effects. Ninety percent of patients surveyed were satisfied to very satisfied with the results from the procedure. About 24% of patients experienced transient nausea, vomiting and/or local hyperpigmentation. Bleomycin sclerotherapy can be an effective treatment of VM with repeat exposure with minor risk of short-term side effects, however, long-term risks are of great concern. Further studies are required to assess systemic absorption and long-term risks. © 2018 Wiley Periodicals, Inc.

    • Outcome of Multifetal Pregnancy Reduction in Women with a Dichorionic Triamniotic Triplet Pregnancy to a Singleton Pregnancy: A Retrospective Nationwide Cohort Study

      NARCIS (Netherlands)

      van de Mheen, L.; Everwijn, S. M. P.; Haak, M. C.; Manten, G. T. R.; Zondervan, H. A.; Knapen, M. F. C. M.; Engels, M. A. J.; Erwich, J. J. H. M.; Coumans, A. B.; van Vugt, J. M. G.; Bilardo, C. M.; van Pampus, M. G.; de Groot, C. J. M.; Mol, B. W. J.; Pajkrt, E.

      2016-01-01

      To study the pregnancy outcomes of women with a dichorionic triamniotic triplet pregnancy that was reduced to a singleton pregnancy and to review the literature. We performed a nationwide retrospective cohort study. We compared time to delivery and perinatal mortality in dichorionic triplet

    • Outcome of Multifetal Pregnancy Reduction in Women with a Dichorionic Triamniotic Triplet Pregnancy to a Singleton Pregnancy : A Retrospective Nationwide Cohort Study

      NARCIS (Netherlands)

      van de Mheen, L.; Everwijn, S. M. P.; Haak, M. C.; Manten, G. T. R.; Zondervan, H. A.; Knapen, M. F. C. M.; Engels, M. A. J.; Erwich, J. J. H. M.; Coumans, A. B.; van Vugt, J. M. G.; Bilardo, C. M.; van Pampus, M. G.; de Groot, C. J. M.; Mol, B. W. J.; Pajkrt, E.

      2016-01-01

      Objective:To study the pregnancy outcomes of women with a dichorionic triamniotic triplet pregnancy that was reduced to a singleton pregnancy and to review the literature. Methods: We performed a nationwide retrospective cohort study. We compared time to delivery and perinatal mortality in

    • Outcome of Multifetal Pregnancy Reduction in Women with a Dichorionic Triamniotic Triplet Pregnancy to a Singleton Pregnancy : A Retrospective Nationwide Cohort Study

      NARCIS (Netherlands)

      Van De Mheen, L.; Everwijn, S. M P; Haak, M. C.; Manten, G. T R; Zondervan, H. A.; Knapen, M. F C M; Engels, M. A J; Erwich, J. J H M; Coumans, A. B.; Van Vugt, J. M G; Bilardo, C. M.; Van Pampus, M. G.; De Groot, C. J M; Mol, B. W J; Pajkrt, E.

      2016-01-01

      Objective: To study the pregnancy outcomes of women with a dichorionic triamniotic triplet pregnancy that was reduced to a singleton pregnancy and to review the literature. Methods: We performed a nationwide retrospective cohort study. We compared time to delivery and perinatal mortality in

  1. A description of the severity of equestrian-related injuries (ERIs) using clinical parameters and patient-reported outcomes.

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    Papachristos, Alexander; Edwards, Elton; Dowrick, Adam; Gosling, Cameron

    2014-09-01

    Despite a number of injury prevention campaigns and interventions, horse riding continues to be a dangerous activity, resulting in more accidents per hour than motorcycling, skiing and football. Injuries are often serious, with one in four patients requiring admission to hospital. This study aims to describe the severity of equestrian-related injuries (ERIs) using both clinical parameters and patient-reported outcomes. A retrospective study of all patients aged ≥18 years admitted to The Alfred Hospital between January 2003 and January 2008 with an ERI was performed. Specific clinical data were extracted from the medical record. In addition, a questionnaire was conducted identifying the details of the accident, the required recovery time and levels of ongoing pain and physical disability. During the study period 172 patients met the inclusion criteria. There were three deaths (2%). Eighty-two patients (48%) suffered head injuries. Forty-one patients (24%) were admitted to the ICU and 31 patients (18%) required mechanical ventilation. On discharge, 41 patients (24%) required transfer to a sub-acute rehabilitation facility. One-hundred-and-twenty-four patients (72%) completed the questionnaire. Thirty-nine respondents (31%) were not wearing a helmet. Among patients injured for more than 6 months, 38 (35%) still experienced moderate or severe pain or disability. Ninety-five patients had returned to work at the time of review, among which 47(50%) required longer than 6 months to recover, and 40 (42%) returned at a reduced capacity. The clinical and patient-reported outcomes of ERIs requiring hospital admission are poor. Persistent pain and disability are common, even up to 5 years post-injury. A large proportion of patients required longer than 6 months to return to work and many return at a reduced capacity. Copyright © 2014 Elsevier Ltd. All rights reserved.

  2. Cognitive interviewing methodology in the development of a pediatric item bank: a patient reported outcomes measurement information system (PROMIS study

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    DeWalt Darren A

    2009-01-01

    Full Text Available Abstract Background The evaluation of patient-reported outcomes (PROs in health care has seen greater use in recent years, and methods to improve the reliability and validity of PRO instruments are advancing. This paper discusses the cognitive interviewing procedures employed by the Patient Reported Outcomes Measurement Information System (PROMIS pediatrics group for the purpose of developing a dynamic, electronic item bank for field testing with children and adolescents using novel computer technology. The primary objective of this study was to conduct cognitive interviews with children and adolescents to gain feedback on items measuring physical functioning, emotional health, social health, fatigue, pain, and asthma-specific symptoms. Methods A total of 88 cognitive interviews were conducted with 77 children and adolescents across two sites on 318 items. From this initial item bank, 25 items were deleted and 35 were revised and underwent a second round of cognitive interviews. A total of 293 items were retained for field testing. Results Children as young as 8 years of age were able to comprehend the majority of items, response options, directions, recall period, and identify problems with language that was difficult for them to understand. Cognitive interviews indicated issues with item comprehension on several items which led to alternative wording for these items. Conclusion Children ages 8–17 years were able to comprehend most item stems and response options in the present study. Field testing with the resulting items and response options is presently being conducted as part of the PROMIS Pediatric Item Bank development process.

  3. Qualitative approach to patient-reported outcomes in oncology: protocol of a French study.

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    Orri, Massimiliano; Sibeoni, Jordan; Labey, Mathilde; Bousquet, Guilhem; Verneuil, Laurence; Revah-Levy, Anne

    2015-07-10

    The past decade has been characterised by movement from a doctor-centred to a patient-centred approach to treatment outcomes, in which doctors try to see the illness through their patients' eyes. Patients, family members and doctors are the three participants in cancer care, but their perspectives about what have been helpful during cancer treatment have never simultaneously and explicitly compared in the same qualitative study. The aim of this study project is to explore patients' perspectives about the care they receive, as well as families' and doctors' perspectives about what have been helpful for the patient. These three points of view will be compared and contrasted in order to analyse the convergences and divergences in these perspectives. This is a national multicentre qualitative study. Participants will be constituted by three different subsamples: (1) patients with cancer (skin, breast, urological and lung cancers), (2) their relatives, and (3) their referring physicians. Recruitment will follow the purposive sample technique, and the final sample size will be determined by data saturation. Data will be collected through open-ended semistructured interviews and independently analysed with NVivo V.10 software by three researchers according to the principles of Interpretative Phenomenological Analysis. The research protocol received approval from the University Paris Descartes review board (IRB number: 20140600001072), and participants will provide written consent. To the best of our knowledge, this is the first study to focus on the simultaneous exploration of the separate points of view of patients, families and doctors about the care received during the cancer care journey. We expect that our findings will help to improve communication and relationships between doctors, patients and families. Comparison of these three points of view will provide information about the convergences and divergences of these perspectives and how to address the needs of all

  4. Patient reported and anatomical outcomes after surgery for pelvic organ prolapse.

    Science.gov (United States)

    El-Azab, Ahmed S; Abd-Elsayed, Alaa A; Imam, Hala M K

    2009-01-01

    Primary aim was to modify Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ) to assess pelvic organ prolapse (POP) in Arabic Muslim women. Secondary aim was to compare functional and anatomical outcomes of POP repair. Questionnaire. A characteristic (prayer) was added to PFIQ. Linguistic validation of questionnaires was then done. Twenty cases were enrolled in a pilot study to test internal consistency and reliability. Subsequent study. Prospective study included women with symptomatic POP >or= stage II. History, examination by POP-Q, and administration of PFDI and PFIQ, were done before and 6 months after surgery. Questionnaire. Internal consistency of added question was good (Cronbach alpha = 0.78). Test-retest reliability of individual PFIQ items was variable. Subsequent Study. Between September 2004 and February 2007, 78 consecutive women were included. Cystocele, rectocele, and no site predominated in 74.4%, 17.9% and 7.7% of cases, respectively. Preoperatively 19.2%, 15.4% and 47.4% reported stress, urge, and mixed incontinence, respectively. Overall and individual urinary symptoms scores improved significantly after surgery. There were significant improvements in individual symptoms of constipation, splint to defecate and losing not well formed stools. Low self-esteem was most negative impact of prolapse on quality of life (QoL) followed by prayer. After surgery 90% of subjects had anatomical cure. After surgery, QoL issues are significantly related to anatomic location of prolapse as determined by POP-Q. Modified PFIQ and PFDI are suitable to assess POP among Muslim women. Postoperatively, many prolapse-related symptoms and QoL significantly improve after surgery on the short term with an anatomic cure rate of 90%.

  5. Patient-Reported Outcomes following Breast Conservation Therapy and Barriers to Referral for Partial Breast Reconstruction.

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    Vrouwe, Sebastian Q; Somogyi, Ron B; Snell, Laura; McMillan, Catherine; Vesprini, Danny; Lipa, Joan E

    2018-01-01

    The purpose of this study was to evaluate the self-reported aesthetic outcome of breast conservation therapy in a generalized sample of patients, and to describe potential barriers to referral for partial breast reconstruction. Consecutive breast conservation therapy patients completing radiotherapy over a 1-year period at a regional cancer center were identified. Eligible patients were contacted by means of mail/e-mail and invited to participate. Participants completed the BREAST-Q breast conservation therapy module along with a questionnaire examining feelings about breast reconstruction. Multiple regression analysis was performed using the satisfaction with breasts scale as the dependent variable. Surveys were completed by 185 of 592 eligible participants (response rate, 31.3 percent; mean age, 61 years) an average of 38 months after lumpectomy. The mean score for the BREAST-Q satisfaction with breasts scale was 59 of 100. Younger age (p = 0.038), lumpectomy reexcision (p = 0.018), and lumpectomy at a nonacademic center (p = 0.026) were significantly associated with lower satisfaction. Bra size, months from lumpectomy, and tumor quadrant/size were not significantly associated with satisfaction (p > 0.05). The most common statements regarding reconstruction were "I don't feel the need for it" (60.0 percent), "I don't like the thought of having breast implants" (22.7 percent), and "I don't want any more surgeon/doctor visits" (22.2 percent). Before lumpectomy, only 1.6 percent had a consultation for reconstruction, and only 22.7 percent were aware of this option. If offered, 33.1 percent of patients would have attended this consultation. There is an unmet demand for partial breast reconstruction, with an opportunity to advocate and increase awareness on behalf of patients undergoing breast conservation therapy.

  6. Patient-reported outcomes of therapy with two brands of ibuprofen

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    Nwidu LL

    2008-09-01

    Full Text Available Objective: To investigate patients’ reported outcome following medication with two brands of 400 mg ibuprofen used to alleviate musculoskeletal pains.Methods: Adult peasant manual laborers (85 who met criteria were randomly assigned to receive either of the brands (A or B. Data on pain alleviation were gathered using the Short-Form McGill Pain Questionnaire (SF-MPQ, Visual Analogue Scale (VAS, Present Pain Intensity (PPI, and Clinical Global Impression of Improvement (CGII scales. Interval data obtained from the two brands were compared using the Students’ t-test at 95% confidence interval.Results: There were 42 participants, mean age=29.2 (SD=1.37 assigned to brand A and 43 (mean age=28.8 SD=1.14 in brand B of ibuprofen 400 mg. Brand B was consistently rated higher than brand A. Scores for medication efficacy were 10.4 (SD=1.65 (brand A and 11.4 (SD=1.68 (brand B; t=2.768, P=0.007. Alleviation of pain symptoms: 10.8 (SD=1.64 and 11.6 (SD=1.72; t = 2.194, P=0.031. Similarly, rated scores on the impact of pain on quality of life were 10.5 (SD=2.00 and 12.1 (SD=1.85; t=3.830, P<0.001. There was a reduction in Present Pain Intensity scores by 32.7% and 34.3% for Brand A and brand B participants respectively. The decrease in Visual Analog pain scale score was 35.9% and 37.3% for brand A and brand B participants respectively. The decrease in SF-MPQ was by 85.1% and 69.9% for the brand A and brand B groups respectively. The clinical global impression of improvement for both groups of patients indicated an improvement rate of 71.4% and 61.9% for brand A and 81.4% and 74.4% for brand B participants. Conclusion: This clinical study infers that though the two brands of ibuprofen 400 mg are legally pharmaceutical equivalent, they are not clinically equivalent. In most of the parameters evaluated, brand B was rated more efficacious than brand A. This explains the patients’ preferences and demand for this brand of ibuprofen in the Nigerian community.

  7. Pre-validation methods for developing a patient reported outcome instrument

    Directory of Open Access Journals (Sweden)

    Castillo Mayret M

    2011-08-01

    Full Text Available Abstract Background Measures that reflect patients' assessment of their health are of increasing importance as outcome measures in randomised controlled trials. The methodological approach used in the pre-validation development of new instruments (item generation, item reduction and question formatting should be robust and transparent. The totality of the content of existing PRO instruments for a specific condition provides a valuable resource (pool of items that can be utilised to develop new instruments. Such 'top down' approaches are common, but the explicit pre-validation methods are often poorly reported. This paper presents a systematic and generalisable 5-step pre-validation PRO instrument methodology. Methods The method is illustrated using the example of the Aberdeen Glaucoma Questionnaire (AGQ. The five steps are: 1 Generation of a pool of items; 2 Item de-duplication (three phases; 3 Item reduction (two phases; 4 Assessment of the remaining items' content coverage against a pre-existing theoretical framework appropriate to the objectives of the instrument and the target population (e.g. ICF; and 5 qualitative exploration of the target populations' views of the new instrument and the items it contains. Results The AGQ 'item pool' contained 725 items. Three de-duplication phases resulted in reduction of 91, 225 and 48 items respectively. The item reduction phases discarded 70 items and 208 items respectively. The draft AGQ contained 83 items with good content coverage. The qualitative exploration ('think aloud' study resulted in removal of a further 15 items and refinement to the wording of others. The resultant draft AGQ contained 68 items. Conclusions This study presents a novel methodology for developing a PRO instrument, based on three sources: literature reporting what is important to patient; theoretically coherent framework; and patients' experience of completing the instrument. By systematically accounting for all items dropped

  8. 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.

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    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.

  9. International Collaboration on Air Pollution and Pregnancy Outcomes (ICAPPO)

    Science.gov (United States)

    Woodruff, Tracey J.; Parker, Jennifer D.; Adams, Kate; Bell, Michelle L.; Gehring, Ulrike; Glinianaia, Svetlana; Ha, Eun-Hee; Jalaludin, Bin; Slama, Rémy

    2010-01-01

    Reviews find a likely adverse effect of air pollution on perinatal outcomes, but variation of findings hinders the ability to incorporate the research into policy. The International Collaboration on Air Pollution and Pregnancy Outcomes (ICAPPO) was formed to better understand relationships between air pollution and adverse birth outcomes through standardized parallel analyses in datasets from different countries. A planning group with 10 members from 6 countries was formed to coordinate the project. Collaboration participants have datasets with air pollution values and birth outcomes. Eighteen research groups with data for approximately 20 locations in Asia, Australia, Europe, North America, and South America are participating, with most participating in an initial pilot study. Datasets generally cover the 1990s. Number of births is generally in the hundreds of thousands, but ranges from around 1,000 to about one million. Almost all participants have some measure of particulate matter, and most have ozone, nitrogen dioxide, sulfur dioxide and carbon monoxide. Strong enthusiasm for participating and a geographically-diverse range of participants should lead to understanding uncertainties about the role of air pollution in perinatal outcomes and provide decision-makers with better tools to account for pregnancy outcomes in air pollution policies. PMID:20644693

  10. Restless Legs Symptoms and Pregnancy and Neonatal Outcomes.

    Science.gov (United States)

    Oyieng'o, D Onentia; Kirwa, Kipruto; Tong, Iris; Martin, Susan; Antonio Rojas-Suarez, José; Bourjeily, Ghada

    2016-02-01

    Restless legs syndrome (RLS) is a commonly occurring neurologic disorder that affects up to one third of women during pregnancy. RLS has been associated with increased sympathetic tone in the nonpregnant population. We examined whether a RLS surrogate is associated with a higher prevalence of pregnancy and neonatal outcomes. Data were analyzed from a cross-sectional survey of 1000 women interviewed soon after delivery by using an RLS surrogate question. Women were asked how frequently (0 = none, 1 = rarely [pregnancy. Clinical charts were reviewed to obtain relevant demographic and clinical data, including the presence of gestational hypertensive disorders and neonatal outcomes at birth. Subjects who "always" experienced RLS were compared with subjects experiencing symptoms less frequently or not at all with respect to prevalence of gestational hypertensive disorder. The mean ([SD]) age, prepregnancy body mass index (BMI), and BMI at delivery were 29.0 (6.1) years, 26.1 (6.2) kg/m(2), and 32.0 (6.3) kg/m(2), respectively. The overall prevalence of the RLS surrogate (jumpy or jerky leg movements) was 35.5% with the following distribution on a Likert scale: score 1 = 6.4%; score 2 = 10.2%; score 3 = 8.1%; and score 4 = 10.8%. Chronic hypertension was present in 2.1%, pregnancy-induced hypertension in 9.5%, and preeclampsia in 4.5% of respondents. Subjects who reported "always" having sensations of jumpy or jerky legs were more likely to have gestational hypertensive disorders compared with those who reported less frequent occurrence of the symptoms. Adjusted odds ratios were 3.74 (95% CI, 1.31-10.72; P = 0.014) for chronic hypertension; 1.26 (95% CI, 0.65-2.46; P = 0.487) for pregnancy-induced hypertension; and 2.15 (95% CI, 0.97-4.75; P = 0.060) for preeclampsia. There was a significant association between leg movement score and neonatal birth weight (coefficient, -149.5 g [95% CI, -276.9 to -22.5]; P = 0.005) and gestational age at birth (-0.7 week [95% CI, -1.1 to

  11. Toward a bioethical issue: induced multiple pregnancies and neonatal outcomes

    Directory of Open Access Journals (Sweden)

    Scorrano Antonio

    2010-11-01

    Full Text Available Abstract Assisted reproductive technology has made great progress during the last three decades. After the initial enthusiasm, many ethical, legal and social issues related to the application of these procedures began to evolve. Multifetal pregnancy and fetal reduction, embryo cryopreservation, preimplantation genetic diagnosis, risks of birth defects and other adverse outcome associated with assisted reproductive technology are issues that have to be addressed building future collaborative studies and continuing the debate on related ethical issues.

  12. 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.

  13. 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

  14. Six Sessions of Anterior-to-Posterior Ankle Joint Mobilizations Improve Patient-Reported Outcomes in Chronic Ankle Instability Patients: A Critically Appraised Topic.

    Science.gov (United States)

    Wikstrom, Erik A; Bagherian, Sajad; Cordero, Nicole B; Song, Kyeongtak

    2018-01-24

    Clinical Scenario: Chronic ankle instability (CAI) is a complex musculoskeletal condition that results in sensorimotor and mechanical alterations. Manual therapies, such as ankle joint mobilizations are known to improve clinician-oriented outcomes like dorsiflexion range of motion but their impact of patient-reported outcomes remains less clear. Focused Clinical Question: Do anterior-to-posterior ankle joint mobilizations improve patient reported outcomes in patients with CAI? Summary of Key Findings: Three studies (2 RCT, 1 Prospective cohort) quantified the effect of at least 2-weeks of anterior-to-posterior ankle joint mobilizations on improving patient reported outcomes immediately after the intervention and at a follow-up assessment. All three studies demonstrated significant improvements in at least one patient-reported outcome immediately after the intervention and at the follow-up assessment. Clinical Bottom Line: At least 2-weeks of ankle joint mobilization improves patient-reported outcomes in patients with CAI and these benefits are retained for at least a week following the termination of the intervention. Strength of Recommendation: Strength of recommendation is an A due to consistent good-quality patient-oriented evidence.

  15. Pregnancy outcome in women with cystic fibrosis-related diabetes.

    Science.gov (United States)

    Reynaud, Quitterie; Poupon-Bourdy, Stéphanie; Rabilloud, Muriel; Al Mufti, Lina; Rousset Jablonski, Christine; Lemonnier, Lydie; Nove-Josserand, Raphaële; Touzet, Sandrine; Durieu, Isabelle

    2017-10-01

    With increasing life expectancy, more women with cystic fibrosis and diabetes mellitus become pregnant. We investigated how pre-gestational diabetes (cystic fibrosis-related diabetes) influenced pregnancy outcome and the clinical status of these women. We analyzed all pregnancies reported to the French cystic fibrosis registry between 2001 and 2012, and compared forced expiratory volume (FEV 1 ) and body mass index before and after pregnancy in women with and without pre-gestational diabetes having a first delivery. A total 249 women delivered 314 infants. Among these, 189 women had a first delivery and 29 of these had pre-gestational diabetes. There was a trend towards a higher rate of assisted conception among diabetic women (53.8%) than non-diabetic women (34.5%, p = 0.06), and the rate of cesarean section was significantly higher in diabetic women (48% vs. 21.4%, p = 0.005). The rate of preterm birth and mean infant birthweight did not differ significantly between diabetic and non-diabetic women. Forced expiratory volume before pregnancy was significantly lower in the diabetic group. The decline in forced expiratory volume and body mass index following pregnancy did not differ between the women with and those without pre-gestational diabetes. Pre-gestational diabetes in women with cystic fibrosis is associated with a higher rate of cesarean section but does not seem to have a clinically significant impact on fetal growth or preterm delivery. The changes in maternal pulmonary and nutritional status following pregnancy in women with cystic fibrosis were not influenced by pre-gestational diabetes. © 2017 Nordic Federation of Societies of Obstetrics and Gynecology.

  16. Myasthenia gravis and pregnancy: clinical implications and neonatal outcome

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    Estanol Bruno

    2004-11-01

    Full Text Available Abstract Background The myasthenia gravis is twice as common in women as in men and frequently affects young women in the second and third decades of life, overlapping with the childbearing years. Generally, during pregnancy in one third of patients the disease exacerbates, whereas in two thirds it remains clinically unchanged. Complete remission can occur in some patients. Methods To describe the clinical course, delivery and neonatal outcome of 18 pregnant women with the diagnosis of myasthenia gravis. Retrospective chart review of pregnant patients with myasthenia gravis, followed at the National Institute of Perinatology in Mexico City over an 8-year period. Data was abstracted from the medical records on the clinical course during pregnancy, delivery and neonatal outcome. Results From January 1, 1996 to December 31, 2003 18 patients with myasthenia gravis were identified and included in the study. The mean ± SD maternal age was 27.4 ± 4.0 years. During pregnancy 2 women (11% had an improvement in the clinical symptoms of myasthenia gravis, 7 women (39% had clinical worsening of the condition of 9 other patients (50% remained clinically unchanged. Nine patients delivered vaginally, 8 delivered by cesarean section and 1 pregnancy ended in fetal loss. Seventeen infants were born at mean ± SD gestational age of 37.5 ± 3.0 weeks and a mean birth weight of 2710 ± 73 g. Only one infant presented with transient neonatal myasthenia gravis. No congenital anomalies were identified in any of the newborns. Conclusions The clinical course of myasthenia gravis during pregnancy is variable, with a significant proportion of patients experiencing worsening of the clinical symptoms. However, neonatal transient myasthenia was uncommon in our patient population.

  17. Adverse pregnancy outcomes after exposure to methylphenidate or atomoxetine during pregnancy

    Directory of Open Access Journals (Sweden)

    Bro SP

    2015-01-01

    Full Text Available Søren Pauli Bro,1 Maiken Ina Siegismund Kjaersgaard,2 Erik Thorlund Parner,2 Merete Juul Sørensen,3 Jørn Olsen,4 Bodil Hammer Bech,4 Lars Henning Pedersen,4,5 Jakob Christensen,6,7 Mogens Vestergaard11Research Unit and Section for General Practice, Department of Public Health, 2Section for Biostatistics, Department of Public Health, Aarhus University, 3Regional Center for Child and Adolescent Psychiatry, Aarhus University Hospital, 4Section for Epidemiology, Department of Public Health, 5Department of Clinical Medicine – Obstetrics and Gynecology, Aarhus University, 6Department of Clinical Pharmacology, 7Department of Neurology, Aarhus University Hospital, Aarhus, DenmarkObjective: To determine if prenatal exposure to methylphenidate (MPH or atomoxetine (ATX increases the risk of adverse pregnancy outcomes in women with attention deficit/hyperactivity disorder (ADHD.Materials and methods: This was a population-based cohort study of all pregnancies in Denmark from 1997 to 2008. Information on use of ADHD medication, ADHD diagnosis, and pregnancy outcomes was obtained from nationwide registers.Results: We identified 989,932 pregnancies, in which 186 (0.02% women used MPH/ATX and 275 (0.03% women had been diagnosed with ADHD but who did not take MPH/ATX. Our reference pregnancies had no exposure to MPH/ATX and no ADHD diagnosis. Exposure to MPH/ATX was associated with an increased risk of spontaneous abortion (SA; ie, death of an embryo or fetus in the first 22 weeks of gestation (adjusted relative risk [aRR] 1.55, 95% confidence interval [CI] 1.03–2.36. The risk of SA was also increased in pregnancies where the mother had ADHD but did not use MPH/ATX (aRR 1.56, 95% CI 1.11–2.20. The aRR of Apgar scores <10 was increased among exposed women (aRR 2.06, 95% CI 1.11–3.82 but not among unexposed women with ADHD (aRR 0.99, 95% CI 0.48–2.05.Conclusion: MPH/ATX was associated with a higher risk of SA, but our study indicated that it may at

  18. Outcomes of pregnancies complicated by liver cirrhosis, portal hypertension, or esophageal varices.

    Science.gov (United States)

    Puljic, Anela; Salati, Jennifer; Doss, Amy; Caughey, Aaron B

    2016-01-01

    To evaluate pregnancy outcomes in women with liver cirrhosis, portal hypertension, or esophageal varices. We analyzed a retrospective cohort of 2,284,218 pregnancies in 2005-2009 recorded in the California Birth Registry database. Utilizing ICD-9 codes we analyzed the following outcomes for liver cirrhosis, portal hypertension, or esophageal varices in pregnancy: preeclampsia (PET), preterm delivery (PTD; Portal hypertension in pregnancy was associated with PTD, LBW, NND, and PPH. Non-bleeding esophageal varices in pregnancy were not associated with the outcomes assessed in a statistically significant manner. One case of bleeding esophageal varices was observed, resulting in PTD with a LBW infant. There were three cases of concomitant portal hypertension or concomitant esophageal varices with cirrhosis in pregnancy. Pregnancy in women with concomitant liver cirrhosis, portal hypertension, or esophageal varices can be successful. However, pregnancy outcomes are worse and may warrant closer antenatal monitoring and patient counseling. Cirrhosis in pregnancy with concomitant portal hypertension or esophageal varices is rare.

  19. Brucellosis in pregnancy: clinical aspects and obstetric outcomes.

    Science.gov (United States)

    Vilchez, Gustavo; Espinoza, Miguel; D'Onadio, Guery; Saona, Pedro; Gotuzzo, Eduardo

    2015-09-01

    Brucellosis is a zoonosis with high morbidity in humans. This disease has gained interest recently due to its re-emergence and potential for weaponization. Pregnant women with this disease can develop severe complications. Its association with adverse obstetric outcomes is not clearly understood. The objective of this study was to describe the obstetric outcomes of brucellosis in pregnancy. Cases of pregnant women with active brucellosis seen at the Hospital Nacional Cayetano Heredia from 1970 to 2012 were reviewed. Diagnostic criteria were a positive agglutination test and/or positive blood/bone marrow culture. Presentation and outcomes data were collected. The Chi-square test was used for nominal variables. A p-value of brucellosis in 6.4%. The most common treatment was aminoglycosides plus rifampicin (42.2% of cases). Complication rates decreased if treatment was started within 2 weeks of presentation (p brucellosis in pregnancy reported in the literature. Brucella presents adverse obstetric outcomes including fetal and maternal/neonatal death. Cases with unexplained spontaneous abortion should be investigated for brucellosis. Prompt treatment is paramount to decrease the devastating outcomes. Copyright © 2015. Published by Elsevier Ltd.

  20. 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

  1. The relationship between salivary bacterial flora and adverse pregnancy outcomes

    Directory of Open Access Journals (Sweden)

    Sadeghi R

    2011-04-01

    Full Text Available "n 800x600 Normal 0 false false false EN-US X-NONE AR-SA MicrosoftInternetExplorer4 /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-parent:""; mso-padding-alt:0in 5.4pt 0in 5.4pt; mso-para-margin:0in; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:10.0pt; font-family:"Times New Roman","serif";} Background: Many studies have shown that periodontal pathogens are emerging as a risk factor for preterm delivery and low birth weight, but there are few studies about the relationship between other oral bacteria and pregnancy outcomes. The aim of the present study was to determine the relationship between salivary bacteria and pregnancy outcomes."n"nMethods: This cohort study was performed on 300 pregnant women who were recruited from the prenatal clinic of Zeynab Hospital in Tehran during 2009-2010. The patients' demographic and pregnancy data were recorded. Using samplers, saliva samples were collected about one hour after breakfast. Microbial evaluation was performed by counting the bacteria based on their shape and the Gram reaction. The studied bacteria were composed of gram-positive and negative cocci, gram-positive and negative bacilli, spirilla, spirochetes, yeasts, fusiform bacteria and actinomycetes."n"nResults: The data on the bacteriological profile and pregnancy outcome of 243 out of the 300 eligible participants of the study were completed. Five cases (2% had intra uterine fetal death (IUFD while 238 (98% delivered live infants. There was a significant statistical relationship between the mean of gram-negative cocci and IUFD (P=0.04. 10 cases (4.1% of 243, experienced adverse delivery outcomes and 233 cases (95% had normal delivery. The adverse pregnancy outcomes had a significant relationship with the presence of spirochetes in saliva (P<0.05 but this relationship was not

  2. Pregnancy after bariatric surgery: improving outcomes for mother and child

    Directory of Open Access Journals (Sweden)

    González I

    2016-12-01

    Full Text Available Irene González,1 Albert Lecube,2 Miguel Ángel Rubio,3 Pedro Pablo García-Luna4 1Endocrinology and Nutrition Department, Complejo Hospitalario Universitario de Huelva, Huelva, Spain; 2Endocrinology and Nutrition Department, Arnau de Vilanova University Hospital, Lleida Biomedicine Research Institute (IRB-Lleida, CIBER in Diabetes and Associated Metabolic Disorders (CIBERDEM, Lleida University, Lleida, Spain; 3Endocrinology and Nutrition Department, Hospital Clínico San Carlos, IDISSC, Madrid, Spain; 4Endocrinology and Nutrition Department, Hospitales Universitarios Virgen del Rocío, Seville, Spain Abstract: The significant increase in the prevalence of obesity has led to an increase in the number of obese women who become pregnant. In this setting, in recent years, there has been an exponential rise in the number of bariatric procedures, with approximately half of them performed in women of childbearing age, and a remarkable surge in the number of women who become pregnant after having undergone bariatric surgery (BS. These procedures entail the risk of nutritional deficiencies, and nutrition is a crucial aspect during pregnancy. Therefore, knowledge and awareness of the consequences of these techniques on maternal and fetal outcomes is essential. Current evidence suggests a better overall obstetric outcome after BS, in comparison to morbid obese women managed conservatively, with a reduction in the prevalence of gestational diabetes mellitus, pregnancy-associated hypertensive disorders, macrosomia, and congenital defects. However, the risk of potential maternal nutritional deficiencies and newborns small for gestational age cannot be overlooked. Results concerning the incidence of preterm delivery and the number of C-sections are less consistent. In this paper, we review the updated evidence regarding the impact of BS on pregnancy. Keywords: bariatric surgery, pregnancy, maternal and fetal outcomes, gestational diabetes mellitus, small for

  3. Etiology and outcome of acute renal failure in pregnancy.

    Science.gov (United States)

    Hassan, Irfana; Junejo, Abdul Manan; Dawani, Manohar Lal

    2009-11-01

    To determine the etiology and outcome of Acute Renal Failure (ARF) in pregnancy. A case series. Nephrology Department of the Jinnah Postgraduate Medical Centre, Karachi, from August 2007 to July 2008. Pregnant women who were healthy previously and had developed ARF, diagnosed on oliguria (urine output 2 mg%) were included in the study. Percutaneous renal biopsy was performed for delayed recovery, i.e. after three weeks. Patients were followed up for a period of 6 months. Percentages were calculated for qualitative variables i.e. causes of ARF, mortality, morbidity and outcome in form of complete recovery, partial recovery, demise and non-recovery. A total of 43 patients with pregnancy-related ARF were included in the study. The puerperal group comprised 36 patients (83.7%). Haemorrhage was the etiology for ARF in 25 (58.1%), antepartum haemorrhage APH in 8 (18.6%) and postpartum haemorrhage PPH in 16 (37.2%) of patients. In 12 (27.9%), puerperal sepsis was the etiological factor, while 4 (9.3%) patients had DIC on presentation. Pre-eclampsia, eclampsia and HELLP syndrome accounted for 5 (11.6%). While 1 (2.3%) was diagnosed with hemolytic uremic syndrome and another one was diagnosed as ARF secondary to hypotension produced by hyperemesis gravidarum. Renal biopsy was performed in 31 patients showing that 10 had acute cortical necrosis and 21 had acute tubular necrosis. Maternal mortality was 16.2% (n=7). Of the 36 (83.7%) surviving patients, 18 (41.4%) had complete recovery of renal function; 12 (27.9%) had partial recovery; and 6 (13.9%) required chronic dialysis. Pregnancy-related ARF was associated with poor outcome. Antepartum and postpartum haemorrhage were the most common cause of ARF in pregnancy.

  4. Validation of the alcohol use item banks from the Patient-Reported Outcomes Measurement Information System (PROMIS).

    Science.gov (United States)

    Pilkonis, Paul A; Yu, Lan; Dodds, Nathan E; Johnston, Kelly L; Lawrence, Suzanne M; Daley, Dennis C

    2016-04-01

    The Patient-Reported Outcomes Measurement Information System (PROMIS) includes five item banks for alcohol use. There are limited data, however, regarding their validity (e.g., convergent validity, responsiveness to change). To provide such data, we conducted a prospective study with 225 outpatients being treated for substance abuse. Assessments were completed shortly after intake and at 1-month and 3-month follow-ups. The alcohol item banks were administered as computerized adaptive tests (CATs). Fourteen CATs and one six-item short form were also administered from eight other PROMIS domains to generate a comprehensive health status profile. After modeling treatment outcome for the sample as a whole, correlates of outcome from the PROMIS health status profile were examined. For convergent validity, the largest correlation emerged between the PROMIS alcohol use score and the Alcohol Use Disorders Identification Test (r=.79 at intake). Regarding treatment outcome, there were modest changes across the target problem of alcohol use and other domains of the PROMIS health status profile. However, significant heterogeneity was found in initial severity of drinking and in rates of change for both abstinence and severity of drinking during follow-up. This heterogeneity was associated with demographic (e.g., gender) and health-profile (e.g., emotional support, social participation) variables. The results demonstrated the validity of PROMIS CATs, which require only 4-6 items in each domain. This efficiency makes it feasible to use a comprehensive health status profile within the substance use treatment setting, providing important prognostic information regarding abstinence and severity of drinking. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  5. Assessing the impact of a remote digital coaching engagement program on patient-reported outcomes in asthma.

    Science.gov (United States)

    Rasulnia, Mazi; Burton, Billy Stephen; Ginter, Robert P; Wang, Tracy Y; Pleasants, Roy Alton; Green, Cynthia L; Lugogo, Njira

    2017-08-11

    Low adherence and poor outcomes provide opportunity for digital coaching to engage patients with uncontrolled asthma in their care to improve outcomes. To examine the impact of a remote digital coaching program on asthma control and patient experience. We recruited 51 adults with uncontrolled asthma, denoted by albuterol use of >2 times per week and/or exacerbations requiring corticosteroids, and applied a 12-week patient-centered remote digital coaching program using a combination of educational pamphlets, symptom trackers, best peak flow establishment, physical activity, and dietary counseling, as well as coaches who implemented emotional enforcement to motivate disease self-management through telephone, text, and email. Baseline and post-intervention measures were quality of life (QOL), spirometry, Asthma Control Test (ACT), Asthma Symptom Utility Index (ASUI), rescue albuterol use, and exacerbation history. Among 51 patients recruited, 40 completed the study. Eight subjects required assistance reading medical materials. Significant improvements from baseline were observed for Patient-Reported Outcomes Measurement Information System mental status (p = 0.010), body weight, and outpatient exacerbation frequency (p = 0.028). The changes from baseline in ACT (p = 0.005) were statistically significant but did not achieve the pre-specified minimum clinically important difference (MCID), whereas for ASUI, the MCID and statistical significance were achieved. Spirometry and rescue albuterol use were no different. A patient-oriented, remote digital coaching program that utilized trained health coaches and digital materials led to statistically significant improvement in mental status, outpatient exacerbations, body weight, and ASUI. Digital coaching programs may improve some outcomes in adults with uncontrolled asthma.

  6. Which is the most useful patient-reported outcome in femoroacetabular impingement? Test-retest reliability of six questionnaires.

    Science.gov (United States)

    Hinman, Rana S; Dobson, Fiona; Takla, Amir; O'Donnell, John; Bennell, Kim L

    2014-03-01

    The most reliable patient-reported outcomes (PROs) for people with femoroacetabular impingement (FAI) is unknown because there have been no direct comparisons of questionnaires. Thus, the aim was to evaluate the test-retest reliability of six existing PROs in a single cohort of young active people with hip/groin pain consistent with a clinical diagnosis of FAI. Young adults with clinical FAI completed six PRO questionnaires on two occasions, 1-2 weeks apart. The PROs were modified Harris Hip Score, Hip dysfunction and Osteoarthritis Score, Hip Outcome Score, Non-Arthritic Hip Score, International Hip Outcome Tool, Copenhagen Hip and Groin Outcome Score. 30 young adults (mean age 24 years, SD 4 years, range 18-30 years; 15 men) with stable symptoms participated. Intraclass correlation coefficient(3,1) values ranged from 0.73 to 0.93 (95% CI 0.38 to 0.98) indicating that most questionnaires reached minimal reliability benchmarks. Measurement error at the individual level was quite large for most questionnaires (minimal detectable change (MDC95) 12.4-35.6, 95% CI 8.7 to 54.0). In contrast, measurement error at the group level was quite small for most questionnaires (MDC95 2.2-7.3, 95% CI 1.6 to 11). The majority of the questionnaires were reliable and precise enough for use at the group level. Samples of only 23-30 individuals were required to achieve acceptable measurement variation at the group level. Further direct comparisons of these questionnaires are required to assess other measurement properties such as validity, responsiveness and meaningful change in young people with FAI.

  7. 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.

  8. Sickle cell disease in pregnancy: trend and pregnancy outcomes at a tertiary hospital in Tanzania.

    Science.gov (United States)

    Muganyizi, Projestine S; Kidanto, Hussein

    2013-01-01

    SCD in pregnancy is associated with increased adverse fetal and maternal outcomes. In Tanzania where the frequency of sickle cell trait is 13% there has been scanty data on SCD in pregnancy. With progressive improvement in childhood survival the burden of SCD in pregnancy will increase. We analyzed all deliveries at Muhimbili National Hospital (MNH) from 1999 to 2011. Fetal and maternal outcomes of SCD deliveries were compared with non-SCD. Data were analyzed using IBM SPSS statistics version 19. Chi square and Fisher Exact tests were used to compare proportions and the independent t-test for continuous data. To predict risks of adverse effects, odds ratios were determined using multivariate logistic regression. A p-valueMNH during the study period, of which 149 were SCD (incidence of 95 SCD per 100,000 deliveries). The incidence of SCD had increased from 76 per 100,000 deliveries in the 1999-2002 period to over 100 per 100,000 deliveries in recent years. The mean maternal age at delivery was lower in SCD (24.0±5.5 years) than in non-SCD deliveries (26.2±6.0 years), pMNH with increased adverse fetal outcomes and excessive maternal mortality mainly due to infections.

  9. Optimization of IVF pregnancy outcomes with donor spermatozoa.

    Science.gov (United States)

    Wang, Jeff G; Douglas, Nataki C; Prosser, Robert; Kort, Daniel; Choi, Janet M; Sauer, Mark V

    2009-03-01

    To identify risk factors for suboptimal IVF outcomes using insemination with donor spermatozoa and to define a lower threshold that may signal a conversion to fertilization by ICSI rather than insemination. Retrospective, age-matched, case-control study of women undergoing non-donor oocyte IVF cycles using either freshly ejaculated (N=138) or cryopreserved donor spermatozoa (N=69). Associations between method of fertilization, semen sample parameters, and pregnancy rates were analyzed. In vitro fertilization of oocytes with donor spermatozoa by insemination results in equivalent fertilization and pregnancy rates compared to those of freshly ejaculated spermatozoa from men with normal semen analyses when the post-processing motility is greater than or equal to 88%. IVF by insemination with donor spermatozoa when the post-processing motility is less than 88% is associated with a 5-fold reduction in pregnancy rates when compared to those of donor spermatozoa above this motility threshold. When the post-processing donor spermatozoa motility is low, fertilization by ICSI is associated with significantly higher pregnancy rates compared to those of insemination. While ICSI does not need to be categorically instituted when using donor spermatozoa in IVF, patients should be counseled that conversion from insemination to ICSI may be recommended based on low post-processing motility.

  10. The Chernobyl accident - did it affect pregnancy outcomes in Norway?

    International Nuclear Information System (INIS)

    Skjeldestad, F.E.; Munch, J.S.; Madland, T.M.

    1992-01-01

    The outcome of pregnancies in the county of Soer-Troendelag in Norway, during the 27 months preceding and 21 months after the Chernobyl accident has been analysed on the basis of time of conception. The analysis showed a significant decrease in the number of conceptions during the three months immediately after the accident (April - June 1986). This finding can be interpreted to mean fewer ''planned'' conceptions. The Chernobyl accident did not seem to have had any impact on the proportion of conceptions ending as spontaneous abortions or ectopic pregnancies. There was a significant drop in the proportion of pregnancies ending as induced abortions during the year after the accident compared with the year before. However, due to some variation during this year, it is difficult to draw any definite conclusions concerning the impact of the accident on induced abortions in this county. The proportion of pregnancies ending as births increased significantly during the year after the Chernobyl accident compared with the year before. 22 refs., 1 tab

  11. Integrating Patient-Reported Outcomes into Spine Surgical Care through Visual Dashboards: Lessons Learned from Human-Centered Design.

    Science.gov (United States)

    Hartzler, Andrea L; Chaudhuri, Shomir; Fey, Brett C; Flum, David R; Lavallee, Danielle

    2015-01-01

    The collection of patient-reported outcomes (PROs) draws attention to issues of importance to patients-physical function and quality of life. The integration of PRO data into clinical decisions and discussions with patients requires thoughtful design of user-friendly interfaces that consider user experience and present data in personalized ways to enhance patient care. Whereas most prior work on PROs focuses on capturing data from patients, little research details how to design effective user interfaces that facilitate use of this data in clinical practice. We share lessons learned from engaging health care professionals to inform design of visual dashboards, an emerging type of health information technology (HIT). We employed human-centered design (HCD) methods to create visual displays of PROs to support patient care and quality improvement. HCD aims to optimize the design of interactive systems through iterative input from representative users who are likely to use the system in the future. Through three major steps, we engaged health care professionals in targeted, iterative design activities to inform the development of a PRO Dashboard that visually displays patient-reported pain and disability outcomes following spine surgery. Design activities to engage health care administrators, providers, and staff guided our work from design concept to specifications for dashboard implementation. Stakeholder feedback from these health care professionals shaped user interface design features, including predefined overviews that illustrate at-a-glance trends and quarterly snapshots, granular data filters that enable users to dive into detailed PRO analytics, and user-defined views to share and reuse. Feedback also revealed important considerations for quality indicators and privacy-preserving sharing and use of PROs. Our work illustrates a range of engagement methods guided by human-centered principles and design recommendations for optimizing PRO Dashboards for patient

  12. Integrating Patient-Reported Outcomes into Spine Surgical Care through Visual Dashboards: Lessons Learned from Human-Centered Design

    Science.gov (United States)

    Hartzler, Andrea L.; Chaudhuri, Shomir; Fey, Brett C.; Flum, David R.; Lavallee, Danielle

    2015-01-01

    Introduction: The collection of patient-reported outcomes (PROs) draws attention to issues of importance to patients—physical function and quality of life. The integration of PRO data into clinical decisions and discussions with patients requires thoughtful design of user-friendly interfaces that consider user experience and present data in personalized ways to enhance patient care. Whereas most prior work on PROs focuses on capturing data from patients, little research details how to design effective user interfaces that facilitate use of this data in clinical practice. We share lessons learned from engaging health care professionals to inform design of visual dashboards, an emerging type of health information technology (HIT). Methods: We employed human-centered design (HCD) methods to create visual displays of PROs to support patient care and quality improvement. HCD aims to optimize the design of interactive systems through iterative input from representative users who are likely to use the system in the future. Through three major steps, we engaged health care professionals in targeted, iterative design activities to inform the development of a PRO Dashboard that visually displays patient-reported pain and disability outcomes following spine surgery. Findings: Design activities to engage health care administrators, providers, and staff guided our work from design concept to specifications for dashboard implementation. Stakeholder feedback from these health care professionals shaped user interface design features, including predefined overviews that illustrate at-a-glance trends and quarterly snapshots, granular data filters that enable users to dive into detailed PRO analytics, and user-defined views to share and reuse. Feedback also revealed important considerations for quality indicators and privacy-preserving sharing and use of PROs. Conclusion: Our work illustrates a range of engagement methods guided by human-centered principles and design

  13. Refractive lens exchange in younger and older presbyopes: comparison of complication rates, 3 months clinical and patient-reported outcomes

    Directory of Open Access Journals (Sweden)

    Schallhorn SC

    2017-08-01

    Full Text Available Steven C Schallhorn,1–3 Julie M Schallhorn,1 Martina Pelouskova,3 Jan A Venter,3 Keith A Hettinger,3 Stephen J Hannan,3 David Teenan3 1Department of Ophthalmology, University of California, San Francisco, CA, USA; 2Roski Eye Institute, University of Southern California, Los Angeles, CA, USA; 3Optical Express, Glasgow UK Purpose: To compare refractive and visual outcomes, patient satisfaction, and complication rates among different age categories of patients who underwent refractive lens exchange (RLE. Methods: A stratified, simple random sample of patients matched on preoperative sphere and cylinder was selected for four age categories: 45–49 years (group A, 50–54 years (group B, 55–59 years (group C, and 60–65 years (group D. Each group contained 320 patients. All patients underwent RLE with a multifocal intraocular lens at least in one eye. Three months postoperative refractive/visual and patient-reported outcomes are presented. Results: The percentage of patients that achieved binocular uncorrected distance visual acuity 20/20 or better was 91.6% (group A, 93.8% (group B, 91.6% (group C, 88.8% (group D, P=0.16. Binocularly, 80.0% of patients in group A, 84.7% in group B, 78.9% in group C, and 77.8% in group D achieved 20/30 or better uncorrected near visual acuity (P=0.13. The proportion of eyes within 0.50 D of emmetropia was 84.4% in group A, 86.8% in group B, 85.7% in group C, and 85.8% in group D (P=0.67. There was no statistically significant difference in postoperative satisfaction, visual phenomena, dry eye symptoms, distance or near vision activities. Apart from higher rate of iritis in the age group 50–55 years, there was no statistically significant difference in postoperative complication rates. Conclusion: RLE can be safely performed in younger as well as older presbyopes. No significant difference was found in clinical or patient-reported outcomes. Keywords: refractive lens exchange, multifocal IOLs, younger

  14. Risk of adverse pregnancy outcome in women exposed to livestock

    DEFF Research Database (Denmark)

    Nielsen, Stine Yde; Henriksen, T B; Hjøllund, Niels Henrik Ingvar

    2013-01-01

    outcome in women with self-reported occupational or domestic contact with livestock compared to pregnant women without such contact. The Danish National Birth Cohort collected information on pregnancy outcome from 100 418 pregnant women (1996-2002) from which three study populations with occupational and....../or domestic exposure to livestock and a reference group of women with no animal contact was sampled. Outcome measures were miscarriage, very preterm birth (before gestational week 32), preterm birth (before 37 gestational weeks), small for gestational age (SGA), and perinatal death. Adverse reproductive...... outcomes were assessed in four different exposure groups of women with occupational or domestic exposure to livestock with no association found between exposure to livestock and miscarriage, preterm birth, SGA or perinatal death. These findings should diminish general occupational health concerns...

  15. The evaluation of perinatal outcomes in pregnancies complicated with thrombophilias

    Directory of Open Access Journals (Sweden)

    Yusuf Taner Kafadar

    2014-06-01

    Full Text Available Aim: In our study we included pregnant patients diagnosed with thrombophilia and evaluated their follow up by thromboprophylaxy for perinatal outcomes. (pregnancy loss, preclampsia,small for gestational age, preterm labour, venous thrombosis. In addition to our study group we aimed to evaluate a control group with negative thrombophilia screen results and hypothesized similar perinatal outcomes in comparison with the study group. Materials-Methods: Pregnant subjects that applied to Çukurova University Hospital, between June 2010 - February 2012 were recruited in the study. Patients with a positive thrombophilia screen for primary and secondary recurrent pregnancy loss were initiated a thromboprophylaxia protocol in the first trimester and their demographic backgrounds and past obstetric histories were also recorded. In addition to this, the type of thrombophilia and number of thrombophilia defects were also noted and the route of birth and perinatal outcomes were evaluated prospectively. The control group included patients who had a history of recurrent unexplained miscarriages, with a negative thrombophilia screen. Differences between both groups were statistically significant at a p value <0.05. Results: 60 patients diagnosed thrombophilia were included in the study group, while 50 patients with unexplained recurrent miscarriage composed the control group. When the perinatal outcomes were compared; pregnancy loss, development of preeclampsia/eclampsia (p=0.257, small for gestational age birth rate (p=0.619, preterm birth rate (p=0.232 and the incidence of venous thrombosis (p=0.246 did not differ significantly. The cesarean section rate in the study group was 55% and 18% in the study group (p=0.000 and it was statistically significant between both groups. Discussion: Our study discovered similar findings and perinatal outcomes in patients with and without thrombophilia. The only significant difference between both groups was the difference in

  16. 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.

  17. The Role of Technical Advances in the Adoption and Integration of Patient-Reported Outcomes in Clinical Care

    Science.gov (United States)

    Jensen, Roxanne E.; Rothrock, Nan E.; DeWitt, Esi Morgan; Spiegel, Brennan; Tucker, Carole A.; Crane, Heidi M.; Forrest, Christopher B.; Patrick, Donald L.; Fredericksen, Rob; Shulman, Lisa M.; Cella, David; Crane, Paul K.

    2016-01-01

    Background Patient-reported outcomes (PROs) are gaining recognition as key measures for improving the quality of patient care in clinical care settings. Three factors have made the implementation of PROs in clinical care more feasible: increased use of modern measurement methods in PRO design and validation, rapid progression of technology (e.g., touch screen tablets, Internet accessibility, and electronic health records (EHRs)), and greater demand for measurement and monitoring of PROs by regulators, payers, accreditors, and professional organizations. As electronic PRO collection and reporting capabilities have improved, the challenges of collecting PRO data have changed. Objectives To update information on PRO adoption considerations in clinical care, highlighting electronic and technical advances with respect to measure selection, clinical workflow, data infrastructure, and outcomes reporting. Methods Five practical case studies across diverse healthcare settings and patient populations are used to explore how implementation barriers were addressed to promote the successful integration of PRO collection into the clinical workflow. The case studies address selecting and reporting of relevant content, workflow integration, pre-visit screening, effective evaluation, and EHR integration. Conclusions These case studies exemplify elements of well-designed electronic systems, including response automation, tailoring of item selection and reporting algorithms, flexibility of collection location, and integration with patient health care data elements. They also highlight emerging logistical barriers in this area, such as the need for specialized technological and methodological expertise, and design limitations of current electronic data capture systems. PMID:25588135

  18. Technical report: an ePRO patient reported outcome program for the evaluation of patients with irritable bowel syndrome.

    Science.gov (United States)

    Gerson, C D; Gerson, M-J

    2014-02-01

    Patient reported outcome (PRO) is an important healthcare concept that describes patient's participation in their care by self-evaluation, usually in the form of questionnaires. This report describes an unique computerized technique, electronic PRO (ePRO), for following the progress of patients with irritable bowel syndrome (IBS). Patients first completed a series of questionnaires, including questions about their illness history, symptom severity, and, in this application, psychological and relationship issues. The symptom severity and psychological questionnaires were then completed at intervals by the patients on their own computers. The ePRO was constructed to allow scores to be automatically summed and placed on a time-line graph for review at the time of the next office visit. Of the 32 patients who completed the initial set of questionnaires, 20 maintained participation in the program for a 6-month period. Of those 20 patients, median number of submissions was 7.0; median interval between questionnaire submissions was 3.0 weeks, whereas median interval between office visits was 5.9 weeks. On average, questionnaire completion took less than 5 min and was positively experienced by the patients. The ePRO program proved to be technically feasible, clinically useful, and positively experienced by the patients. It provides a focus on a collaborative conversation between physician and patient. It has significant potential as a technique for evaluating outcome in response to various therapies. © 2013 John Wiley & Sons Ltd.

  19. Outcome of Adolescent Pregnancy: A Retrospective Cohort Study

    Directory of Open Access Journals (Sweden)

    S Ozdogan

    2015-05-01

    Full Text Available Objective: The aim of this study is to review the sociodemographic characteristics, maternal, natal and postnatal outcomes of adolescent pregnancy. Subjects and method: The records of all adolescent pregnancies (aged 13–19 years delivered at Sisli Hamidiye Etfal Research and Training Hospital, Istanbul, Turkey, over a period of two years were reviewed. Structured survey was conducted with adolescent mothers over the phone. Results: The incidence of adolescent pregnancy was 7.06%; 91.1% of the cases were reported to be married. Consanguineous marriage was found to be 27.6%. Maternal anaemia was detected in 43.1% of cases. Premature birth rate was 6.3%. The rate of Cesarean section was 31.8%. Adolescent mothers were categorized into two groups: 17 years and below and above 17 years. The maternal, natal and postnatal outcomes were not statistically different between the two groups. Conclusions: Health policies should be revised and improved to take the necessary steps for providing adequate health services for adolescents and for improving prenatal, natal and postnatal care of pregnant adolescents.

  20. Factors predicting the outcome of acute renal failure in pregnancy

    International Nuclear Information System (INIS)

    Khana, N.; Akhtar, F.

    2010-01-01

    To determine the factors predicting renal outcome in patients developing acute renal failure in pregnancy. Study Design: Descriptive cohort study. Place and Duration of Study: Study was conducted at Nephrology Unit of Sindh Institute of Urology and Transplantation, Karachi, from October 2006 to March 2007. Methodology: Patients with acute renal failure due to complications of pregnancy, with normal size of both the kidneys on ultrasound were enrolled, and followed for a period of 60 days or until recovery of renal function. Patient's age and parity, presence of antenatal care, type of complication of pregnancy, foetal outcome and duration of oliguria were compared between patients who remained dialysis dependent and those who recovered renal function. Chi-square/Fisher's exact test and student's t-test, were used for determining the association of categorical and continuous variables with dialysis dependency. Results: The mean age was 29 +- 6 years. Most patients came from rural areas of interior Sindh. Sixty eight percent did not have antenatal checkups. Antepartum haemorrhage (p=0.002) and prolonged duration of oliguria (35 +- 15.7 days, p= < 0.001) were associated with dialysis dependency, which was observed in 50% of the study group. Conclusion: Ante-partum haemorrhage and prolonged oliguria were strong predictors of irreversible renal failure. This highlights the need for early recognition and referral, and the importance of trained birth attendants and antenatal care. (author)

  1. Impact of noise and air pollution on pregnancy outcomes.

    Science.gov (United States)

    Gehring, Ulrike; Tamburic, Lillian; Sbihi, Hind; Davies, Hugh W; Brauer, Michael

    2014-05-01

    Motorized traffic is an important source of both air pollution and community noise. While there is growing evidence for an adverse effect of ambient air pollution on reproductive health, little is known about the association between traffic noise and pregnancy outcomes. We evaluated the impact of residential noise exposure on small size for gestational age, preterm birth, term birth weight, and low birth weight at term in a population-based cohort study, for which we previously reported associations between air pollution and pregnancy outcomes. We also evaluated potential confounding of air pollution effects by noise and vice versa. Linked administrative health data sets were used to identify 68,238 singleton births (1999-2002) in Vancouver, British Columbia, Canada, with complete covariate data (sex, ethnicity, parity, birth month and year, income, and education) and maternal residential history. We estimated exposure to noise with a deterministic model (CadnaA) and exposure to air pollution using temporally adjusted land-use regression models and inverse distance weighting of stationary monitors for the entire pregnancy. Noise exposure was negatively associated with term birth weight (mean difference = -19 [95% confidence interval = -23 to -15] g per 6 dB(A)). In joint air pollution-noise models, associations between noise and term birth weight remained largely unchanged, whereas associations decreased for all air pollutants. Traffic may affect birth weight through exposure to both air pollution and noise.

  2. Maternal and fetal outcomes associated with vagus nerve stimulation during pregnancy

    DEFF Research Database (Denmark)

    Sabers, Anne; Battino, Dina; Bonizzoni, Erminio

    2017-01-01

    OBJECTIVE: To access the effect of vagus nerve stimulation (VNS) on the outcome of pregnancy. METHODS: We used the International Registry of Antiepileptic Drugs and Pregnancy (EURAP) and its network to search for women receiving adjunctive VNS during pregnancy. Data on maternal and fetal outcomes...

  3. OUTCOME OF PREGNANCIES COMPLICATED BY THREATENED ABORTION IN THE SECOND TRIMESTER OF PREGNANCY - PROSPECTIVE STUDY

    Directory of Open Access Journals (Sweden)

    Rajeswary

    2015-11-01

    Full Text Available AIM: To compare the outcome of pregnancies complicated by bleeding per vaginum between 14- 20 weeks with those not complicated by bleeding per vaginum before 20 weeks. To evaluate the potential determinants of outcome such as gestational age at bleeding, number of bleeding episodes, extent of placental separation or sub chorionic bleed, incidence of complications as placenta previa, abruptio placenta, development of gestational hypertension and pre eclampsia, intra uterine growth restriction, and neonatal outcomes as birth weight, mode of delivery, neonatal ICU admission, and congenital anomalies. SETTINGS AND DESIGN: This was a prospective, comparative study, for a duration of one year. STUDY POPULATION: Cases- 100 women admitted in IMCH with first episode of bleeding per vaginum between 14- 20 weeks and continuing their pregnancy after 20 weeks. CONTROLS: 200 uncomplicated pregnancies attending antenatal outpatient clinic which were followed up till delivery. EXCLUSION CRITERIA: 1. Women with history of threatened abortion in first trimester were not included in the study. 2. Subjects age more than 35 years. 3. Previous history of abortion. 4. Any significant medical, surgical or gynecological history. RESULTS: When patients who presented with bleeding pv after completion of 1st trimester were analyzed by USS, a significant number of them had evidence of sub chorionic bleed, heavier the bleed, more the likelihood of presence of sub placental hematoma. There was no significant difference in prevalence of development of hypertensive disorders of pregnancy in both study groups. There was no significant rise in ante partum hemorrhage between cases and controls. Incidence of IUGR, PPROM, PRE TERM LABOR was significantly increased in study group. LSCS rate was not significantly different in both groups. In this study, there was no significant difference in incidence of congenital anomalies in both groups. STUDY AREA: Tertiary health center

  4. Patient-Reported Outcome and Observer-Reported Outcome Assessment in Rare Disease Clinical Trials: An ISPOR COA Emerging Good Practices Task Force Report.

    Science.gov (United States)

    Benjamin, Katy; Vernon, Margaret K; Patrick, Donald L; Perfetto, Eleanor; Nestler-Parr, Sandra; Burke, Laurie

    Rare diseases (RDs) affect a small number of people within a population. About 5000 to 8000 distinct RDs have been identified, with an estimated 6% to 8% of people worldwide suffering from an RD. Approximately 75% of RDs affect children. Frequently, these conditions are heterogeneous; many are progressive. Regulatory incentives have increased orphan drug designations and approvals. To develop emerging good practices for RD outcomes research addressing the challenges inherent in identifying, selecting, developing, adapting, and implementing patient-reported outcome (PRO) and observer-reported outcome (ObsRO) assessments for use in RD clinical trials. This report outlines the challenges and potential solutions in determining clinical outcomes for RD trials. It follows the US Food and Drug Administration Roadmap to Patient-Focused Outcome Measurement in Clinical Trials. The Roadmap consists of three columns: 1) Understanding the Disease or Condition, 2) Conceptualizing Treatment Benefit, and 3) Selecting/Developing the Outcome Measure. Challenges in column 1 include factors such as incomplete natural history data and heterogeneity of disease presentation and patient experience. Solutions include using several information sources, for example, clinical experts and patient advocacy groups, to construct the condition's natural history and understand treatment patterns. Challenges in column 2 include understanding and measuring treatment benefit from the patient's perspective, especially given challenges in defining the context of use such as variations in age or disease severity/progression. Solutions include focusing on common symptoms across patient subgroups, identifying short-term outcomes, and using multiple types of COA instruments to measure the same constructs. Challenges in column 3 center around the small patient population and heterogeneity of the condition or study sample. Few disease-specific instruments for RDs exist. Strategies include adapting existing

  5. The relationship between pain severity and patient-reported outcomes among patients with chronic low back pain in Japan

    Directory of Open Access Journals (Sweden)

    Montgomery W

    2016-06-01

    Full Text Available William Montgomery,1 Jeffrey Vietri,2 Jing Shi,3 Kei Ogawa,4 Sawako Kariyasu,4 Levent Alev,4 Masaya Nakamura5 1Eli Lilly Australia Pty Ltd., Sydney, NSW, Australia; 2Health Outcomes Practice, Kantar Health, Horsham, PA, 3Health Outcomes Practice, Kantar Health, Princeton, NJ, USA; 4Eli Lilly Japan K.K., Kobe, Japan; 5Department of Orthopedic Surgery, Keio University School of Medicine, Tokyo, Japan Objective: The aim of this study was to quantify the impact of pain severity on patient-reported outcomes among individuals diagnosed with chronic low back pain in Japan. Methods: Data were provided by the 2012 Japan National Health and Wellness Survey (N=29,997, a web-based survey of individuals in Japan aged ≥18 years. This analysis included respondents diagnosed with low back pain of ≥3-month duration. Measures included the revised Medical Outcomes Study 36-Item Short-Form Survey Instrument, the Patient Health Questionnaire-9, the Generalized Anxiety Disorder-7 scale, the Work Productivity and Activity Impairment: General Health questionnaire, and self-reported all-cause health care visits (6 months. Generalized linear models were used to assess the relationship between outcomes and severity of pain in the past week as reported on a numeric rating scale ranging from 0 (no pain to 10 (pain as bad as you can imagine, controlling for length of diagnosis, sociodemographics, and general health characteristics. Results: A total of 290 respondents were included in the analysis; mean age was 56 years, 41% were females, and 56% were employed. Pain severity was 3/10 for the first quartile, 5/10 for the median, and 7/10 for the third quartile of this sample. Increasing severity was associated with lower scores for mental and physical component summaries and Short-Form 6D health utility, higher depression (Patient Health Questionnaire-9 and anxiety (Generalized Anxiety Disorder-7 scores, greater absenteeism and presenteeism, greater activity impairment

  6. Perinatal outcome of pregnancies complicated by threatened abortion.

    Science.gov (United States)

    Verma, S K; Premi, H K; Gupta, T V; Thakur, S; Gupta, K B; Randhawa, I

    1994-11-01

    One hundred and two cases of viable pregnancies with threatened abortion were studied in the department of obstetrics and gynaecology, Kamla Nehru Hospital, IG Medical College, Shimla between November 1987 and February 1989 and their perinatal outcome was evaluated. The pregnancies continued beyond 28 weeks in 61.7% of the cases. The incidence of prematurity was 19.0%. The incidence of low birth weight (LBW) babies was 23.8%. Apgar score was less than 7 in 22.3%. The incidence of neonatal complications was 25.3%. There was no perinatal mortality. In a control group of 50 cases, the incidence of prematurity and LBW was 8% and 4% respectively. Apgar score less than 7 was noted in 4% and neonatal complications were observed only in 4% of newborns.

  7. Obstetric outcome with low molecular weight heparin therapy during pregnancy.

    LENUS (Irish Health Repository)

    Donnelly, J

    2012-01-01

    This was a prospective study of women attending a combined haematology\\/obstetric antenatal clinic in the National Maternity Hospital (2002-2008). Obstetric outcome in mothers treated with low molecular weight heparin (LMWH) was compared to the general obstetric population of 2006. There were 133 pregnancies in 105 women. 85 (63.9%) received prophylactic LMWH and 38 (28.6%) received therapeutic LMWH in pregnancy. 10 (7.5%) received postpartum prophylaxis only. The perinatal mortality rate was 7.6\\/1000 births. 14 (11.3%) women delivered preterm which is significantly higher than the hospital population rate (5.7%, p<0.05). Despite significantly higher labour induction rates (50% vs 29.2% p<0.01), there was no difference in CS rates compared to the general hospital population (15.4% vs 18.9%, NS). If carefully managed, these high-risk women can achieve similar vaginal delivery rates as the general obstetric population.

  8. 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.

  9. 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.

  10. Transverse pinning versus intramedullary pinning in fifth metacarpal's neck fractures: A randomized controlled study with patient-reported outcome.

    Science.gov (United States)

    Galal, Sherif; Safwat, Wael

    2017-01-01

    The 5th metacarpal fractures accounts for 38% of all hand fractures given that the neck is the weakest point in metacarpals, so neck fracture is the most common metacarpal fracture. Surgical fixation is also advocated for such fractures to prevent mal-rotation of the little finger which will lead to fingers overlap in a clenched fist. Various methods are available for fixation of such fractures, like intramedullary & transverse pinning. There are very few reports in the literature comparing both techniques. Authors wanted to compare outcomes and complications of transverse pinning versus intramedullary pinning in fifth metacarpal's neck fractures. A single-center, parallel group, prospective, randomized study was conducted at an academic Level 1 Trauma Center from October 2014 to December 2016. A total of 80 patients with 5th metacarpal's neck fractures were randomized to pinning using either transverse pinning (group A) or intramedullary pinning (group B). Patients were assessed clinically on range of motion, patient-reported outcome using the Quick-DASH (Disabilities of the Arm, Shoulder, and Hand) questionnaire & radiographically. Two blinded observers assessed outcomes. At final follow up for each patient (12 months) the statistically significant differences were observed in operative time, the transverse pinning group showed shorter operative time, as well as complication rate as complications were observed only in intramedullary pinning group. No differences were found in range of motion or the Quick -DASH score. Both techniques are equally safe and effective treatment option for 5th metacarpal's neck fractures. The only difference was shorter operative time & less incidence of complications in transverse pinning group. Level II, Therapeutic study.

  11. Pathogenic mechanisms linking periodontal diseases with adverse pregnancy outcomes.

    Science.gov (United States)

    Cetin, I; Pileri, P; Villa, A; Calabrese, S; Ottolenghi, L; Abati, S

    2012-06-01

    In the last 2 decades, a large proportion of studies have focused on the relationship between maternal periodontal disease and poor obstetric outcomes. The aim of the present review is to summarize the current knowledge about human studies on the pathogenetic mechanisms linking periodontal diseases with adverse pregnancy outcomes. A search of the medical literature was conducted using NIH (National Institute of Health) Pubmed through April 2011. Articles were identified with the Medical Subject Heading (MeSH) and free text terms "small for gestational age (SGA)," "preeclampsia," "preterm labor," and "periodontal disease." Experimental human studies have shown that periodontal pathogens may disseminate toward placental and fetal tissues accompanied by an increase in inflammatory mediators in the placenta. As such, new inflammatory reactions within the placental tissues of the pregnant woman may occur, the physiological levels of prostaglandin E(2) (PGE(2)) and tumor necrosis factor-α (TNF-α) in the amniotic fluid may increase and eventually lead to premature delivery. Although many data from clinical trials suggest that periodontal disease may increase the adverse pregnancy outcome, the exact pathogenetic mechanism involved remains controversial. The findings explain the potential link between periodontal infections and adverse pregnancy outcomes. First, periodontal bacteria can directly cause infections both of the uteroplacenta and the fetus; second, systemic inflammatory changes induced by periodontal diseases can activate responses at the maternal-fetal interface. Of note, associative studies have produced different results in different population groups and no conclusive evidence has still been produced for the potential role of preventive periodontal care to reduce the risk factors of preterm birth.

  12. Validation of Patient-Reported Outcomes Measurement Information System (PROMIS) computerized adaptive tests in cervical spine surgery.

    Science.gov (United States)

    Boody, Barrett S; Bhatt, Surabhi; Mazmudar, Aditya S; Hsu, Wellington K; Rothrock, Nan E; Patel, Alpesh A

    2018-03-01

    OBJECTIVE The Patient-Reported Outcomes Measurement Information System (PROMIS), which is funded by the National Institutes of Health, is a set of adaptive, responsive assessment tools that measures patient-reported health status. PROMIS measures have not been validated for surgical patients with cervical spine disorders. The objective of this project is to evaluate the validity (e.g., convergent validity, known-groups validity, responsiveness to change) of PROMIS computer adaptive tests (CATs) for pain behavior, pain interference, and physical function in patients undergoing cervical spine surgery. METHODS The legacy outcome measures Neck Disability Index (NDI) and SF-12 were used as comparisons with PROMIS measures. PROMIS CATs, NDI-10, and SF-12 measures were administered prospectively to 59 consecutive tertiary hospital patients who were treated surgically for degenerative cervical spine disorders. A subscore of NDI-5 was calculated from NDI-10 by eliminating the lifting, headaches, pain intensity, reading, and driving sections and multiplying the final score by 4. Assessments were administered preoperatively (baseline) and postoperatively at 6 weeks and 3 months. Patients presenting for revision surgery, tumor, infection, or trauma were excluded. Participants completed the measures in Assessment Center, an online data collection tool accessed by using a secure login and password on a tablet computer. Subgroup analysis was also performed based on a primary diagnosis of either cervical radiculopathy or cervical myelopathy. RESULTS Convergent validity for PROMIS CATs was supported with multiple statistically significant correlations with the existing legacy measures, NDI and SF-12, at baseline. Furthermore, PROMIS CATs demonstrated known-group validity and identified clinically significant improvements in all measures after surgical intervention. In the cervical radiculopathy and myelopathic cohorts, the PROMIS measures demonstrated similar responsiveness to the

  13. 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

  14. Pregnancy Outcome of Abnormal Nuchal Translucency: A Systematic Review.

    Science.gov (United States)

    Roozbeh, Nasibeh; Azizi, Maryam; Darvish, Leili

    2017-03-01

    Nuchal Translucency (NT) is the sonographic form of subcutaneous gathering of liquid behind the foetal neck in the first trimester of pregnancy. There is association of increased NT with chromosomal and non-chromosomal abnormalities. The purpose of this systemic review was to review the pregnancy outcome of abnormal nuchal translucency. The present systematic review was conducted by searching English language articles from sources such as International Medical Sciences, Medline, Web of science, Scopus, Google Scholar, PubMed, Index Copernicus, DOAJ, EBSCO-CINAHL. Persian articles were searched from Iranmedex and SID sources. Related key words were "outcome", "pregnancy", "abnormal", and "Nuchal Translucency" (NT). All, randomized, descriptive, analytic-descriptive, case control study conducted during 1997-2015 were included. Including duplicate articles, 95 related articles were found. After reviewing article titles, 30 unrelated article and abstracts were removed, and 65 articles were evaluated of which 30 articles were duplicate. Finally 22 articles were selected for final analysis. Exclusion criteria were, case studies and reports and quasi experimental designs. This evaluation has optioned negative relationship between nuchal translucency and pregnancy result. Rate of cardiac, chromosomal and other defects are correlated with increased NT≥2.5mm. Cardiac disease which were associated to the increased NT are heart murmur, systolic organic murmur, Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD), tricuspid valve insufficiency and pulmonary valve insufficiency, Inferior Vena Cava (IVC) and Patent Ductus Arteriosus (PDA). The most common problems that related with increased NT were allergic symptoms. According to this systematic review, increased NT is associated with various foetal defects. To verify the presence of malformations, birth defect consultations with a perinatologist and additional tests are required.

  15. Correlation between pregnancy outcomes and hormone levels in early pregnancy of women with threatened abortion and subchorionic hematoma

    Directory of Open Access Journals (Sweden)

    Xiao-Hua Liu

    2016-02-01

    Full Text Available Objective: To investigate the correlation between pregnancy outcomes and hormone levels in early pregnancy of women with threatened abortion and subchorionic hematoma. Methods: Three groups of subjects (48 cases each were selected including the group of healthy pregnant women (Group C, and the two groups of subchorionic hematoma diagnosed via B-ultrasound examination with and without (Groups A and B positive symptoms of threatened abortion such as abdominal pain, colporrhagia etc. Chemiluminescence analysis was applied to determine serum progesterone and HCG levels of all three groups, and investigate the correlation between variations of such levels and pregnancy outcomes. Results: Statistical significance existed in the differences between serum progesterone and HCG levels of the three groups at 12, 28 and 37 weeks of gestation. In early pregnancy, serum progesterone and β-HCG levels were lower in Group A than Groups B and C, and lower in Group B than Group C. In the second trimester, the serum β-HCG level was higher, while the progesterone level lower in Group A than Groups B and C; the serum β-HCG level higher, while the progesterone level lower in Group B than Group C. And the comparative results in late pregnancy were the same as those of the second trimester. The premature birth rate, abortion rate, fetal death rate were the highest, and the full time delivery rate was the lowest in Group A among all the three groups. Adverse pregnancy outcomes of women with threatened abortion and subchorionic hematoma were closely related to serum progesterone and HCG levels in early gestation. Conclusion: Serum progesterone and HCG levels in early pregnancy of women with threatened abortion and subchorionic hematoma are positively correlated with pregnancy outcomes; the lower such levels of the two early indicators, the higher the incidence of adverse pregnancy outcomes. Therefore, tests of early pregnancy serum progesterone and HCG levels can be

  16. 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...

  17. Platelet Count in First Trimester of Pregnancy as a Predictor of Perinatal Outcome

    Directory of Open Access Journals (Sweden)

    Santiago Garcia-Tizon Larroca

    2017-02-01

    CONCLUSIONS: Maternal and pregnancy factors can poorly predict relevant changes in PLT at the first trimester of gestation. PLT at first trimester of pregnancy might predict adverse perinatal outcome in combination with other markers.

  18. Depression screening and patient outcomes in pregnancy or postpartum : A systematic review

    NARCIS (Netherlands)

    Thombs, Brett D.; Arthurs, Erin; Coronado-Montoya, Stephanie; Roseman, Michelle; Delisle, Vanessa C.; Leavens, Allison; Levis, Brooke; Azoulay, Laurent; Smith, Cheri; Ciofani, Luisa; Coyne, James C.; Feeley, Nancy; Gilbody, Simon; Schinazi, Joy; Stewart, Donna E.; Zelkowitz, Phyllis

    Objective: Clinical practice guidelines disagree on whether health care professionals should screen women for depression during pregnancy or postpartum. The objective of this systematic review was to determine whether depression screening improves depression outcomes among women during pregnancy or

  19. Folic acid supplementation during pregnancy for maternal health and pregnancy outcomes.

    Science.gov (United States)

    Lassi, Zohra S; Salam, Rehana A; Haider, Batool A; Bhutta, Zulfiqar A

    2013-03-28

    During pregnancy, fetal growth causes an increase in the total number of rapidly dividing cells, which leads to increased requirements for folate. Inadequate folate intake leads to a decrease in serum folate concentration, resulting in a decrease in erythrocyte folate concentration, a rise in homocysteine concentration, and megaloblastic changes in the bone marrow and other tissues with rapidly dividing cells To assess the effectiveness of oral folic acid supplementation alone or with other micronutrients versus no folic acid (placebo or same micronutrients but no folic acid) during pregnancy on haematological and biochemical parameters during pregnancy and on pregnancy outcomes. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 December 2012) and we contacted major organisations working in micronutrient supplementation, including UNICEF Nutrition Section, World Health Organization (WHO) Maternal and Reproductive Health, WHO Nutrition Division, and National Center on Birth defects and Developmnetal Disabilities, US Centers for Disease Control and Prevention (CDC). All randomised, cluster-randomised and cross-over controlled trials evaluating supplementation of folic acid alone or with other micronutrients versus no folic acid (placebo or same micronutrients but no folic acid) in pregnancy. Two review authors independently assessed trials for inclusion, assessed risk of bias and extracted data. Data were checked for accuracy. Thirty-one trials involving 17,771 women are included in this review. This review found that folic acid supplementation has no impact on pregnancy outcomes such as preterm birth (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.73 to 1.38; three studies, 2959 participants), and stillbirths/neonatal deaths (RR 1.33, 95% CI 0.96 to 1.85; three studies, 3110 participants). However, improvements were seen in the mean birthweight (mean difference (MD) 135.75, 95% CI 47.85 to 223.68). On the other hand, the review

  20. The use of a patient-reported outcome questionnaire to assess cancer survivorship concerns and psychosocial outcomes among recent survivors.

    Science.gov (United States)

    Palmer, Steven C; Stricker, Carrie T; DeMichele, Angela M; Schapira, Marilyn; Glanz, Karen; Griggs, Jennifer J; Jacobs, Linda A

    2017-08-01

    Survivor distress is well represented in the literature, but less is known about survivors' concerns and how these relate to adaptation. Using a newly designed Survivorship Concern Scale, we examined concerns and their relationship to psychosocial adaptation among recent breast cancer (BC) survivors. One hundred forty-three stage 0-III BC survivors completed an online assessment including the Survivorship Concern Scale (0-3 scale; alpha = 0.91), unmet needs, quality of life (QoL), and anxiety and depressive symptoms within 1 year of end of treatment. Participants were predominately white (76%), middle-aged (51 years), married (70%), and college educated (79%). Eighty-two percent were stage I or II at diagnosis. Mean degree of survivorship concern was moderate (M = 1.75, SD = 0.70) though variable (range = 0.12-3.00). Survivorship concerns were not significantly related to disease, treatment, or demographic variables except income (p = 0.02). Degree of survivorship concern was significantly associated with all indices of psychosocial adaptation: unmet need (r = 0.50), physical and mental QoL (r = -0.32 and r = -0.32, respectively), depressive symptoms (r = 0.21), and anxiety symptoms (r = 0.51; all p psychosocial adaptation. Adequately addressing concerns may be a way to improve psychosocial outcomes early in the survivorship trajectory.

  1. Psychosocial outcomes and counselee satisfaction following genetic counseling for hereditary breast and ovarian cancer: A patient-reported outcome study.

    Science.gov (United States)

    Oberguggenberger, Anne; Sztankay, Monika; Morscher, Raphael Johannes; Sperner-Unterweger, Barbara; Weber, Ingrid; Hubalek, Michael; Kemmler, Georg; Zschocke, Johannes; Martini, Caroline; Egle, Daniel; Dünser, Martina; Gamper, Eva; Meraner, Verena

    2016-10-01

    We investigated the psychosocial consequences of genetic counseling and testing (GCT) for hereditary breast and ovarian cancer (HBOC) at follow-up in a "real-life" sample of counselees at an Austrian tertiary care center. The study cohort included counselees who had undergone genetic counseling for HBOC and completed a follow-up self-report questionnaire battery on psychosocial outcomes (quality of life, psychological distress, satisfaction with counseling and decisions). For comparison of distress, we recruited a reference sample of breast cancer survivors (BCS; n=665) who had not requested GCT in the same setting. Overall, counselees did not exhibit increased levels of anxiety and depression when compared to BCS. No specific follow-up deleterious psychosocial consequences were detected among the former group. Of the 137 counselees, 22.6% and 9.8% experienced clinically relevant levels of anxiety and depression, respectively, at an average follow-up time of 1.8years. However, both anxiety and depression significantly decreased with time and were alike between counselees with and without cancer diagnosis. Follow-up cancer worry seems to be significantly higher among counselees who had not undergone genetic testing or were undecided about it than among counselees who had been tested. Our results strongly support GCT as part of routine care for patients with HBOC. The risk factors of increased distress in specific subgroups of counselees, such as recent cancer diagnosis or uncertainty about testing, warrant further exploration and specific attention in clinical routines. Particularly, the psychological needs of undecided counselees warrant ongoing attention and potential follow-ups. Copyright © 2016 Elsevier Inc. All rights reserved.

  2. Home visits during pregnancy: consequences on pregnancy outcome, use of health services, and women's situations.

    Science.gov (United States)

    Blondel, B; Bréart, G

    1995-08-01

    This review of eight randomized controlled trials assessed two different types of home visits during pregnancy: (1) those offering social support to high-risk women; and (2) those providing medical care to women with complications. In both categories, pregnancy outcome was not improved when women received home visits. The summary odds ratio for preterm delivery (better integration of hospital and home services might allow a more rational use of health services for women with complications. In addition, we need to define more precisely the content of home visits providing social support. For this, further research is required on how emotional support, health education, and advice influence the health of women and infants and mother-child interactions.

  3. Physical violence during pregnancy: maternal complications and birth outcomes.

    Science.gov (United States)

    Cokkinides, V E; Coker, A L; Sanderson, M; Addy, C; Bethea, L

    1999-05-01

    To assess the association between physical violence during the 12 months before delivery and maternal complications and birth outcomes. We used population-based data from 6143 women who delivered live-born infants between 1993 and 1995 in South Carolina. Data on women's physical violence during pregnancy were based on self-reports of "partner-inflicted physical hurt and being involved in a physical fight." Outcome data included maternal antenatal hospitalizations, labor and delivery complications, low birth weights, and preterm births. Odds ratios and 95% confidence intervals were calculated to measure the associations between physical violence, maternal morbidity, and birth outcomes. The prevalence of physical violence was 11.1%. Among women who experienced physical violence, 54% reported having been involved in physical fights only and 46% had been hurt by husbands or partners. In the latter group, 70% also reported having been involved in fighting. Compared with those not reporting physical violence, women who did were more likely to deliver by cesarean and be hospitalized before delivery for maternal complications such as kidney infection, premature labor, and trauma due to falls or blows to the abdomen. Physical violence during the 12 months before delivery is common and is associated with adverse maternal conditions. The findings support the need for research on how to screen for physical violence early in pregnancy and to prevent its consequences.

  4. Development and initial psychometric evaluation of patient-reported outcome questionnaires to evaluate the symptoms and impact of hidradenitis suppurativa.

    Science.gov (United States)

    Kimball, Alexa B; Sundaram, Murali; Banderas, Benjamin; Foley, Catherine; Shields, Alan L

    2018-03-01

    Two patient-reported outcome (PRO) questionnaires, the Hidradenitis Suppurativa Symptom Assessment (HSSA) and Hidradenitis Suppurativa Impact Assessment (HSIA), were developed to measure signs, symptoms and impacts of HS in treatment efficacy studies. In accordance with FDA guidelines and published best practices, four stages of research were conducted to create the questionnaires: concept elicitation, questionnaire construction, content evaluation and psychometric evaluation. Subjects (N = 20) who participated in the concept elicitation stage reported 15 unique HS-related signs and symptoms and 51 impacts. Following this, eight sign and symptom concepts and 21 impacts were selected for construction of the HSSA and HSIA, respectively. During content evaluation, cognitive debriefing interviews with HS subjects (N = 20) confirmed subjects could read, comprehend and meaningfully respond to both questionnaires. Modifications made after this stage of work resulted in a nine-item HSSA and a 17-item HSIA. The HSSA and HSIA were subsequently entered into a US-based