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Sample records for patient-reported outcome questionnaires

  1. 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

  2. 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.

  3. The OnyCOE-t™ questionnaire: responsiveness and clinical meaningfulness of a patient-reported outcomes questionnaire for toenail onychomycosis

    Directory of Open Access Journals (Sweden)

    Kianifard Farid

    2006-08-01

    Full Text Available Abstract Background This research was conducted to confirm the validity and reliability and to assess the responsiveness and clinical meaningfulness of the OnyCOE-t™, a questionnaire specifically designed to measure patient-reported outcomes (PRO associated with toenail onychomycosis. Methods 504 patients with toenail onychomycosis randomized to receive 12 weeks of terbinafine 250 mg/day with or without target toenail debridement in the IRON-CLAD® trial completed the OnyCOE-t™ at baseline, weeks 6, 12, 24, and 48. The OnyCOE-t™ is composed of 6 multi-item scales and 1 single-item scale. These include a 7-item Toenail Symptom assessment, which comprises both Symptom Frequency and Symptom Bothersomeness scales; an 8-item Appearance Problems scale; a 7-item Physical Activities Problems scale; a 1-item Overall Problem scale; a 7-item Stigma scale; and a 3-item Treatment Satisfaction scale. In total, 33 toenail onychomycosis-specific items are included in the OnyCOE-t™. Clinical data, in particular the percent clearing of mycotic involvement in the target toenail, and OnyCOE-t™ responses were used to evaluate the questionnaire's reliability, validity, responsiveness, and the minimally clinical important difference (MCID. Results The OnyCOE-t™ was shown to be reliable and valid. Construct validity and known groups validity were acceptable. Internal consistency reliability of multi-item scales was demonstrated by Cronbach's alpha > .84. Responsiveness was good, with the Treatment Satisfaction, Symptom Frequency, Overall Problem, and Appearance Problem scales demonstrating the most responsiveness (Guyatt's statistic of 1.72, 1.31, 1.13, and 1.11, respectively. MCID was evaluated for three different clinical measures, and indicated that approximately an 8.5-point change (on a 0 to 100 scale was clinically meaningful based on a 25% improvement in target nail clearing. Conclusion The OnyCOE-t™ questionnaire is a unique, toenail-specific PRO

  4. 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...

  5. 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.

  6. 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 observational study (N = 40), and the scores produced by each were found to be reliable, construct valid, and able to distinguish among clinically distinct groups. The HSSA and HSIA are content-valid, HS-specific, PRO questionnaires with demonstrated ability to generate reliable, valid scores when administered to patients with HS in a research setting.

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

    Science.gov (United States)

    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

    2008-10-16

    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. 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 using Internet focus groups (IFGs). IFGs were conducted with German (n = 26) and US (n = 28) sufferers of oily skin. Questionnaire items were generated using coded transcript data from the focus groups. Cognitive debriefing was conducted online with 42 participants and face to face with an additional five participants to assess the comprehension of the items. There were equal numbers of male and female participants; mean age was 35.4 (SD 9.3) years. On average, participants had had oily skin for 15.2 years, and 74% (n = 40) reported having mild-moderate acne. Participants reported using visual, tactile and sensory (feel without touching their face) methods to evaluate the severity of facial oiliness. Oily facial skin had both an emotional and social impact, and was associated with feelings of unattractiveness, self-consciousness, embarrassment, irritation and frustration. Items were generated for a measure of oily skin severity (Oily Skin Self-Assessment Scale) and a measure of the impact of oily skin on emotional well-being (Oily Skin Impact Scale). Cognitive debriefing resulted in minor changes to the draft items and confirmed their face and content validity. The research provides insight into the experience of having oily skin and illustrates significant difficulties associated with the condition. Item content was developed for early versions of two PRO measures of the symptoms and emotional impact of oily facial skin. The psychometric validation of these measures reported elsewhere.

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

    Directory of Open Access Journals (Sweden)

    Draelos Zoe

    2008-10-01

    Full Text Available 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 using Internet focus groups (IFGs. IFGs were conducted with German (n = 26 and US (n = 28 sufferers of oily skin. Questionnaire items were generated using coded transcript data from the focus groups. Cognitive debriefing was conducted online with 42 participants and face to face with an additional five participants to assess the comprehension of the items. Results There were equal numbers of male and female participants; mean age was 35.4 (SD 9.3 years. On average, participants had had oily skin for 15.2 years, and 74% (n = 40 reported having mild-moderate acne. Participants reported using visual, tactile and sensory (feel without touching their face methods to evaluate the severity of facial oiliness. Oily facial skin had both an emotional and social impact, and was associated with feelings of unattractiveness, self-consciousness, embarrassment, irritation and frustration. Items were generated for a measure of oily skin severity (Oily Skin Self-Assessment Scale and a measure of the impact of oily skin on emotional well-being (Oily Skin Impact Scale. Cognitive debriefing resulted in minor changes to the draft items and confirmed their face and content validity. Conclusion The research provides insight into the experience of having oily skin and illustrates significant difficulties associated with the condition. Item content was developed for early versions of two PRO measures of the symptoms and emotional impact of oily facial skin. The psychometric validation of

  9. Relative performance of commonly used physical function questionnaires in rheumatoid arthritis and a patient-reported outcomes measurement information system computerized adaptive test

    NARCIS (Netherlands)

    Oude Voshaar, Antonius H.; ten Klooster, Peter M.; Glas, Cornelis A.W.; Vonkeman, Harald Erwin; Krishnan, Eswar; van de Laar, Mart A F J

    2014-01-01

    OBJECTIVE: To evaluate and compare the measurement precision and sensitivity to change of the Health Assessment Questionnaire disability index (HAQ DI), the Short Form 36 physical functioning scale (PF-10), and simulated Patient-Reported Outcomes Measurement Information System (PROMIS) physical

  10. 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...

  11. 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.

  12. Patient-reported outcome (PRO) questionnaires for men who have radical surgery for prostate cancer: a conceptual review of existing instruments.

    Science.gov (United States)

    Protopapa, Evangelia; van der Meulen, Jan; Moore, Caroline M; Smith, Sarah C

    2017-10-01

    To critically review conceptual frameworks for available patient-reported outcome (PRO) questionnaires in men having radical prostatectomy (RP), psychometrically evaluate each questionnaire, and identify whether each is appropriate for use at the level of the individual patient. We searched PubMed, the Reports and Publications database of the University of Oxford Patient-Reported Outcomes Measurement Group and the website of the International Consortium for Health Outcomes Measurement (ICHOM) for psychometric reviews of prostate cancer-specific PRO questionnaires. From these we identified relevant questionnaires and critically appraised the conceptual content, guided by the Wilson and Cleary framework and psychometric properties, using well established criteria. The searches found four reviews and one recommendation paper. We identified seven prostate cancer-specific PROs: the Expanded Prostate Cancer Index Composite-26 (EPIC-26), Expanded Prostate Cancer Index Composite-50 (EPIC-50), University of California-Los Angeles Prostate Cancer Index (UCLA-PCI), Functional Assessment of Cancer Therapy - Prostate Cancer Subscale (FACT-P PCS), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - prostate specific 25-item (EORTC QLQ-PR25), Prostate Cancer - Quality of Life (PC-QoL), and Symptom Tracking and Reporting (STAR). Six out of seven measures purported to measure health-related quality of life (HRQL), but items focused strongly on urinary and sexual symptoms/functioning. The remaining questionnaire (STAR) claimed to assess functional recovery after RP. The psychometric evidence for these questionnaires was incomplete and variable in quality; none had evidence that they were appropriate for use with individual patients. Several questionnaires provide the basis of measures of urinary and/or sexual symptoms/functioning. Further work should explore other aspects of HRQL that are important for men having RP. Further psychometric work

  13. The importance of rating scale design in the measurement of patient-reported outcomes using questionnaires or item banks.

    Science.gov (United States)

    Khadka, Jyoti; McAlinden, Colm; Gothwal, Vijaya K; Lamoureux, Ecosse L; Pesudovs, Konrad

    2012-06-26

    To investigate the effect of rating scale designs (question formats and response categories) on item difficulty calibrations and assess the impact that rating scale differences have on overall vision-related activity limitation (VRAL) scores. Sixteen existing patient-reported outcome instruments (PROs) suitable for cataract assessment, with different rating scales, were self-administered by patients on a cataract surgery waiting list. A total of 226 VRAL items from these PROs in their native rating scales were included in an item bank and calibrated using Rasch analysis. Fifteen item/content areas (e.g., reading newspapers) appearing in at least three different PROs were identified. Within each content area, item calibrations were compared and their range calculated. Similarly, five PROs having at least three items in common with the Visual Function (VF-14) were compared in terms of average item measures. A total of 614 patients (mean age ± SD, 74.1 ± 9.4 years) participated. Items with the same content varied in their calibration by as much as two logits; "reading the small print" had the largest range (1.99 logits) followed by "watching TV" (1.60). Compared with the VF-14 (0.00 logits), the rating scale of the Visual Disability Assessment (1.13 logits) produced the most difficult items and the Cataract Symptom Scale (0.24 logits) produced the least difficult items. The VRAL item bank was suboptimally targeted to the ability level of the participants (2.00 logits). Rating scale designs have a significant effect on item calibrations. Therefore, constructing item banks from existing items in their native formats carries risks to face validity and transmission of problems inherent in existing instruments, such as poor targeting.

  14. The development and validation of a multidimensional sum-scaling questionnaire to measure patient-reported outcomes in acute respiratory tract infections in primary care: the Acute Respiratory Tract Infection Questionnaire: ARTIQ

    DEFF Research Database (Denmark)

    Aabenhus, R.; Thorsen, H.; Siersma, V.

    2013-01-01

    OBJECTIVE: Patient-reported outcomes are seldom validated measures in clinical trials of acute respiratory tract infections (ARTIs) in primary care. We developed and validated a patient-reported outcome sum-scaling measure to assess the severity and functional impacts of ARTIs. METHODS: Qualitative...... interviews and field testing among adults with an ARTI were conducted to ascertain a high degree of face and content validity of the questionnaire. Subsequently, a draft version of the Acute Respiratory Tract Infection Questionnaire (ARTIQ) was statistically validated by using the partial credit Rasch model......, sum-scaling questionnaire with high face and content validity and adequate psychometric properties for assessing severity and functional impacts from ARTIs in adults is available to clinical trials and audits in primary care....

  15. Development and content validity testing of a patient-reported outcomes questionnaire for the assessment of hereditary angioedema in observational studies.

    Science.gov (United States)

    Bonner, Nicola; Abetz-Webb, Linda; Renault, Lydie; Caballero, Teresa; Longhurst, Hilary; Maurer, Marcus; Christiansen, Sandra; Zuraw, Bruce

    2015-07-01

    Hereditary Angioedema (HAE), a rare genetic disease, manifests as intermittent, painful attacks of angioedema. Attacks vary in frequency and severity and include skin, abdominal and life-threatening laryngeal swellings. This study aimed to develop a patient reported outcome (PRO) tool for the assessment of HAE attacks, including their management and impact on patients' lives, for use in clinical studies, or by physicians in general practice. The results of open-ended face to face concept elicitation interviews with HAE patients in Argentina (n = 10) and the US (n = 33) were used to develop the first draft questionnaire of the HAE patient reported outcomes questionnaire (HAE PRO). Subsequently, in-depth cognitive debriefing interviews were performed with HAE patients in the UK (n = 10), Brazil (n = 10), Germany (n = 11) and France (n = 12). Following input from eight multinational clinical experts further cognitive interviews were conducted in the US (n = 12) and Germany (n = 12). Patients who experienced abdominal, cutaneous or laryngeal attacks of varying severity levels were included in all rounds of interviews. Across the rounds of interviews patients discussed their HAE attack symptoms, impacts and treatments. Cognitive debriefing interviews explored patient understanding and relevance of questionnaire items. All interviews were conducted face to face following a pre-defined semi-structured interview guide in the patient's native language. Patients reported a variety of HAE symptoms, attack triggers, warning signs, attack impacts and treatment options which were used to develop the HAE PRO. The HAE PRO was revised and refined following input from patients and clinical experts. The final 18-item HAE PRO provides an assessment of the HAE attack experience including symptoms, impacts, treatment requirements, healthcare resource use and loss of productivity caused by HAE attacks. Patient and expert input has contributed to the

  16. The development and validation of a multidimensional sum-scaling questionnaire to measure patient-reported outcomes in acute respiratory tract infections in primary care: the acute respiratory tract infection questionnaire.

    Science.gov (United States)

    Aabenhus, Rune; Thorsen, Hanne; Siersma, Volkert; Brodersen, John

    2013-01-01

    Patient-reported outcomes are seldom validated measures in clinical trials of acute respiratory tract infections (ARTIs) in primary care. We developed and validated a patient-reported outcome sum-scaling measure to assess the severity and functional impacts of ARTIs. Qualitative interviews and field testing among adults with an ARTI were conducted to ascertain a high degree of face and content validity of the questionnaire. Subsequently, a draft version of the Acute Respiratory Tract Infection Questionnaire (ARTIQ) was statistically validated by using the partial credit Rasch model to test dimensionality, objectivity, and reliability of items. Test of known groups' validity was conducted by comparing participants with and without an ARTI. The final version of the ARTIQ consisted of 38 items covering five dimensions (Physical-upper, Physical-lower, Psychological, Sleep, and Medicine) and five single items. All final dimensions were confirmed to fit the Rasch model, thus enabling sum-scaling of responses. The ARTIQ scores in participants with an ARTI were significantly higher than in those without ARTI (known groups' validity). A self-administered, multidimensional, sum-scaling questionnaire with high face and content validity and adequate psychometric properties for assessing severity and functional impacts from ARTIs in adults is available to clinical trials and audits in primary care. Copyright © 2013, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc.

  17. 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....

  18. Content Validity of the Hypogonadism Impact of Symptoms Questionnaire (HIS-Q): A Patient-Reported Outcome Measure to Evaluate Symptoms of Hypogonadism.

    Science.gov (United States)

    Gelhorn, Heather L; Vernon, Margaret K; Stewart, Katie D; Miller, Michael G; Brod, Meryl; Althof, Stanley E; DeRogatis, Leonard R; Dobs, Adrian; Seftel, Allen D; Revicki, Dennis A

    2016-04-01

    Hypogonadism, or low testosterone, is a common disorder. There are currently no patient-reported outcome (PRO) instruments designed to comprehensively evaluate the symptoms of hypogonadism and to detect changes in these symptoms in response to treatment. The purpose of this study was to develop a PRO instrument, the Hypogonadism Impact of Symptoms Questionnaire (HIS-Q) and to assess its content validity. A literature review, expert clinician input, and qualitative concept elicitation with 39 male hypogonadism patients (four focus groups: n = 25; individual interviews: n = 14; mean age 52.3 ± 14.3 years) from the USA were used to develop the draft HIS-Q. Subsequent cognitive interviews (n = 29; mean age 51.5 ± 15.4 years) were used to evaluate content validity. Emergent discussion with participants yielded symptoms within the sexual, physical, energy, sleep, cognition, and mood domains. Low libido and tiredness were most commonly reported. The initial version of the HIS-Q includes 53 items that were consistently understood by the participants, who found the instrument to be relevant to their experiences with hypogonadism and comprehensive in the content coverage of symptoms. The HIS-Q is a comprehensive PRO measure of hypogonadism symptom severity in males. Its design elements, including the response options and recall period, were suitable, and content validity was confirmed.

  19. 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...

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

    Directory of Open Access Journals (Sweden)

    Yasser El Miedany

    2016-01-01

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

  1. Patients’ attitudes and perceptions of two health-related quality-of-life questionnaires used to collect patient-reported outcome measures in the English National Health Service: A qualitative study of patients undergoing cardiac interventions

    Directory of Open Access Journals (Sweden)

    Bashir M Matata

    2013-09-01

    Full Text Available Objectives: To explore patients’ views on the EuroQol-5D and Coronary Revascularisation Outcome Questionnaire, tools currently used for collecting patient-reported outcome measures in the English National Health Service. The key questions were as follows: (1 whether patients consider them sensitive enough to detect change in their health after cardiovascular disease interventions and (2 whether they consider the health-related quality-of-life questions as meaningful. Methods: Data were collected on patients’ views using focus groups. We held four focus groups selecting participants on the basis of their baseline and follow-up EuroQol-5D scores. Data were analysed using framework analysis and grounded theory. Results: Focus group participants confirmed that they had derived substantial health benefits from their cardiac interventions despite the lack of measurable effects on the EuroQol-5D scores. Participants felt that the EuroQol-5D questionnaire was limited because of the following reasons: Their health fluctuates from day to day. They had difficulty assessing their general health status on the visual analogue scale. They felt that the Coronary Revascularisation Outcome Questionnaire was limited because of the following reasons: They did not understand the clinical terms used. The impact of tiredness on their quality of life was not captured. They were unable to distinguish between the effects of their heart condition and other health issues. Additionally, neither questionnaire considers the adjustments people have made to their domestic arrangements to improve their health-related quality of life. Conclusion: This study provides evidence that the two questionnaires do not capture some aspects of health that patients consider important. Furthermore, the presence of co-morbidities masks the symptoms relating to the heart disease and the effect of their cardiac interventions. Future work on patient-reported outcome measures should consider

  2. Imputation by the mean score should be avoided when validating a Patient Reported Outcomes questionnaire by a Rasch model in presence of informative missing data

    LENUS (Irish Health Repository)

    Hardouin, Jean-Benoit

    2011-07-14

    Abstract Background Nowadays, more and more clinical scales consisting in responses given by the patients to some items (Patient Reported Outcomes - PRO), are validated with models based on Item Response Theory, and more specifically, with a Rasch model. In the validation sample, presence of missing data is frequent. The aim of this paper is to compare sixteen methods for handling the missing data (mainly based on simple imputation) in the context of psychometric validation of PRO by a Rasch model. The main indexes used for validation by a Rasch model are compared. Methods A simulation study was performed allowing to consider several cases, notably the possibility for the missing values to be informative or not and the rate of missing data. Results Several imputations methods produce bias on psychometrical indexes (generally, the imputation methods artificially improve the psychometric qualities of the scale). In particular, this is the case with the method based on the Personal Mean Score (PMS) which is the most commonly used imputation method in practice. Conclusions Several imputation methods should be avoided, in particular PMS imputation. From a general point of view, it is important to use an imputation method that considers both the ability of the patient (measured for example by his\\/her score), and the difficulty of the item (measured for example by its rate of favourable responses). Another recommendation is to always consider the addition of a random process in the imputation method, because such a process allows reducing the bias. Last, the analysis realized without imputation of the missing data (available case analyses) is an interesting alternative to the simple imputation in this context.

  3. Development of the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT®) questionnaire: a new patient-reported outcome instrument for PAH.

    Science.gov (United States)

    McCollister, Deborah; Shaffer, Shannon; Badesch, David B; Filusch, Arthur; Hunsche, Elke; Schüler, René; Wiklund, Ingela; Peacock, Andrew

    2016-06-14

    Regulators and clinical experts increasingly recognize the importance of incorporating patient-reported outcomes (PROs) in clinical studies of therapies for pulmonary arterial hypertension (PAH). No PAH-specific instruments have been developed to date in accordance with the 2009 FDA guidance for the development of PROs as endpoints in clinical trials. A qualitative research study was conducted to develop a new instrument assessing PAH symptoms and their impacts following the FDA PRO guidance. A cross-sectional study was conducted at 5 centers in the US in symptomatic PAH patients aged 18-80 years. Concept elicitation was based on 5 focus group discussions, after which saturation of emergent concepts was reached. A PRO instrument for PAH symptoms and their impacts was drafted. To assess the appropriateness of items, instructions, response options, and recall periods, 2 rounds of one-on-one cognitive interviews were conducted, with instrument revisions following each round. Additional interviews tested the usability of an electronic version (ePRO). PRO development considered input from an international Steering Committee, and translatability and lexibility assessments. Focus groups comprised 25 patients (5 per group); 20 additional patients participated in cognitive interviews (10 per round); and 10 participated in usability interviews. Participants had a mean ± SD age of 53.1 ± 15.8 years, were predominantly female (93 %), and were diverse in race/ethnicity, WHO functional class (FC I/II: 56 %, III/IV: 44 %), and PAH etiology (idiopathic: 56 %, familial: 2 %, associated: 42 %). The draft PRO instrument (PAH-SYMPACT®) was found to be clear, comprehensive, and relevant to PAH patients in cognitive interviews. Items were organized in a draft conceptual framework with 16 symptom items in 4 domains (respiratory symptoms, tiredness, cardiovascular symptoms, other symptoms) and 25 impact items in 5 domains (physical activities, daily activities, social

  4. Patient-Reported Outcomes Assessed by the CAMPHOR Questionnaire Predict Clinical Deterioration in Idiopathic Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension

    Science.gov (United States)

    McCabe, Colm; Bennett, Maxine; Doughty, Natalie; MacKenzie Ross, Robert; Sharples, Linda

    2013-01-01

    Background: The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) is a disease-specific assessment tool used for the evaluation and follow-up of patients with pulmonary hypertension (PH). We describe a novel use for this questionnaire in its potential to predict clinical deterioration (CD) in two patient cohorts with subtypes of PH, idiopathic pulmonary arterial hypertension (IPAH), and chronic thromboembolic pulmonary hypertension (CTEPH) during an 8-year period. Methods: We retrospectively analyzed CAMPHOR scores obtained at baseline and at follow-up visits in patients under the care of our unit over an 8-year period to assess CD and survival, as well as 6-min walk distance (6MWD) and New York Heart Association (NYHA) class. Results: Using Cox regression, we demonstrated a significant predictive effect of CD from total CAMPHOR scores at study enrollment in IPAH and CTEPH (hazard ratios, 1.03 [95% CI, 1.01-1.05] and 1.04 [95% CI, 1.02-1.06] per unit score increase, respectively), as well as from CAMPHOR subscales as independent predictors. This predictive effect is diluted after adjusting for the prognostic effect of 6MWD and NYHA class. Repeated CAMPHOR assessment over time appears not to add predictive value of CD to that obtained at diagnosis, although it still informs physicians of important changes in self-reported symptoms. Conclusions: When emphasis is placed on the evaluation of patient perceptions, CAMPHOR may represent an alternative method of estimating the likelihood of CD. PMID:23430021

  5. Worse patient-reported outcome after lateral approach than after anterior and posterolateral approach in primary hip arthroplasty. A cross-sectional questionnaire study of 1,476 patients 1-3 years after surgery.

    Science.gov (United States)

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

    2014-09-01

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

  6. 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

  7. Development and validation of the impact of dry eye on everyday life (IDEEL) questionnaire, a patient-reported outcomes (PRO) measure for the assessment of the burden of dry eye on patients.

    Science.gov (United States)

    Abetz, Linda; Rajagopalan, Krithika; Mertzanis, Polyxane; Begley, Carolyn; Barnes, Rod; Chalmers, Robin

    2011-12-08

    To develop and validate a comprehensive patient-reported outcomes instrument focusing on the impact of dry eye on everyday life (IDEEL). Development and validation of the IDEEL occurred in four phases: 1) focus groups with 45 dry eye patients to develop a draft instrument, 2) item generation, 3) pilot study to assess content validity in 16 patients and 4) psychometric validation in 210 subjects: 130 with non-Sjögren's keratoconjunctivitis sicca, 32 with Sjögren's syndrome and 48 controls, and subsequent item reduction. Focus groups identified symptoms and the associated bother, the impact of dry eye on daily life and the patients' satisfaction with their treatment as the central concepts in patients' experience of dry eye. Qualitative analysis indicated that saturation was achieved for these concepts and yielded an initial 112-item draft instrument. Patients understood the questionnaire and found the items to be relevant indicating content validity. Patient input, item descriptive statistics and factor analysis identified 55 items that could be deleted. The final 57-item IDEEL assesses dry eye impact constituting 3 modules: dry eye symptom-bother, dry eye impact on daily life comprising impact on daily activities, emotional impact, impact on work, and dry eye treatment satisfaction comprising satisfaction with treatment effectiveness and treatment-related bother/inconvenience. The psychometric analysis results indicated that the IDEEL met the criteria for item discriminant validity, internal consistency reliability, test-retest reliability and floor/ceiling effects. As expected, the correlations between IDEEL and the Dry Eye Questionnaire (a habitual symptom questionnaire) were higher than between IDEEL and Short-Form-36 and EuroQoL-5D, indicating concurrent validity. The IDEEL is a reliable, valid and comprehensive questionnaire relevant to issues that are specific to dry eye patients, and meets current FDA patient-reported outcomes guidelines. The use of this

  8. 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 ...

  9. 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.

  10. 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

  11. Identifying patient-centred recommendations for improving patient safety in General Practices in England: a qualitative content analysis of free-text responses using the Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) questionnaire.

    Science.gov (United States)

    Ricci-Cabello, Ignacio; Saletti-Cuesta, Lorena; Slight, Sarah P; Valderas, Jose M

    2017-10-01

    There is a growing interest in identifying strategies to achieve safer primary health-care provision. However, most of the research conducted so far in this area relies on information supplied by health-care providers, and limited attention has been paid to patients' perspectives. To explore patients' experiences and perceptions of patient safety in English general practices with the aim of eliciting patient-centred recommendations for improving patient safety. The Patient Reported Experiences and Outcomes of Safety in Primary Care questionnaire was sent to a random sample of 6736 primary care users registered in 45 English practices. We conducted a qualitative content analysis of responses to seven open-ended items addressing patients' experiences of safety problems, lessons learnt as a result of such experiences and recommendations for safer health care. A total of 1244 (18.4%) participants returned completed questionnaires. Of those, 678 (54.5%) responded to at least one open-ended question. Two main themes emerged as follows: (i) experiences of safety problems and (ii) good practices and recommendations to improve patient safety in primary care. Most frequent experiences of safety problems were related to appointments, coordination between providers, tests, medication and diagnosis. Patients' responses to these problems included increased patient activation (eg speaking up about concerns with their health care) and avoidance of unnecessary health care. Recommendations for safer health care included improvements in patient-centred communication, continuity of care, timely appointments, technical quality of care, active monitoring, teamwork, health records and practice environment. This study identified a number of patient-centred recommendations for improving patient safety in English general practices. © 2017 The Authors Health Expectations Published by John Wiley & Sons Ltd.

  12. 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

  13. 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.

  14. Development of a patient-reported outcome

    DEFF Research Database (Denmark)

    Sørensen, Tina Juul; 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...

  15. Patient reported outcomes in hip arthroplasty registries.

    Science.gov (United States)

    Paulsen, Aksel

    2014-05-01

    PROs are used increasingly in orthopedics and in joint registries, but still many aspects of use in this area have not been examined in depth. To be able to introduce PROs in the DHR in a scientific fashion, my studies were warranted; the feasibility of four often used PROs (OHS, HOOS, EQ-5D and SF-12) was examined in a registry context. Having the PROs in the target language is an absolute necessity, so I translated, cross-culturally adapted and validated a Danish language version of an often used PRO (OHS), since this PRO had no properly developed Danish language version. To minimize data loss and to maximize the data quality I validated our data capture procedure, an up to date AFP system, by comparing scannable, paper-based PROs, with manual single-key- and double-key entered data. To help further registry-PRO studies, I calculated the number of patients needed to discriminate between subgroups of age, sex, diagnosis, and prosthesis type for each of four often used PROs (OHS, HOOS, EQ-5D and SF-12), and to simplify the clinical interpretation of PRO scores and PRO change scores in PRO studies, I estimated MCII and PASS for two often used PROs (EQ-5D and HOOS). The feasibility study included 5,747 THA patients registered in the DHR, and I found only minor differences between the disease-specific and the generic PROs regarding ceiling and floor effects as well as discarded items. The HOOS, the OHS, the SF-12, and the EQ-5D are all appropriate PROs for administration in a hip registry. I found that group sizes from 51 to 1,566 were needed for subgroup analysis, depending on descriptive factors and choice of PRO. The AFP study included 200 THA patients (398 PROs, 4,875 items and 21,887 data fields), and gave excellent results provided use of highly structured questionnaires. OMR performed equally as well as manual double-key entering, and better than single-key entering. The PRO translation and validation study included 2,278 patients (and 212 patients for the test

  16. Development of a patient-reported questionnaire for collecting toxicity data following prostate brachytherapy

    International Nuclear Information System (INIS)

    Farnell, Damian J.J.; Mandall, Paula; Anandadas, Carmel; Routledge, Jaqueline; Burns, Meriel P.; Logue, John P.; Wylie, James P.; Swindell, Ric; Livsey, Jac; West, Catharine M.L.; Davidson, Susan E.

    2010-01-01

    Purpose: To improve a questionnaire used to collect patient-reported outcomes from patients with early stage prostate cancer treated with brachytherapy. A secondary aim was to adapt the Late Effects of Normal Tissue (LENT) subjective toxicity questionnaire for use to collect Common Terminology Criteria for Adverse Events (CTCAE) data, the current preferred platform for assessing radiation toxicity. Materials and methods: Three hundred and seventy-seven patients were treated with permanent iodine-125 seed implant brachytherapy for early prostate cancer. Toxicity data were collected before and at nine time points post-treatment (0-36 months). Compliance rates for patients completing individual items and item-subsection correlation coefficients were calculated. A factor analysis was carried out to analyse responses to the questionnaire and identify less informative questions, which could be removed. Cronbach's α coefficient was used to measure reliability. Results: Two thousand one hundred and eighty-eight questionnaires were analysed. There was poor compliance for questions specifically relating to operations and bowel medication. We found that the division of the questionnaire into subsections based on anatomical site was reasonable and that certain items could be safely removed. The high mean value for Cronbach's α across all questionnaires (0.752; 95% CI: 0.726-0.779) indicated that the questionnaire was reliable. Fifteen of the 44 questions were removed from the original questionnaires. Questions on urinary incontinence severity, management of urinary and bowel incontinence, effects of reduced flow of urine and the effects of symptoms on activity of daily living and change in sexual function were required to adapt the LENT subjective questionnaire for use to collect CTCAE data. Conclusions: A questionnaire, validated over 6 years to collect LENT subjective data were adapted and is a reliable approach for collecting CTCAE data after prostate brachytherapy.

  17. 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.

  18. 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.

  19. Patient-reported physical activity questionnaires: A systematic review of content and format

    Science.gov (United States)

    2012-01-01

    Background Many patients with chronic illness are limited in their physical activities. This systematic review evaluates the content and format of patient-reported outcome (PRO) questionnaires that measure physical activity in elderly and chronically ill populations. Methods Questionnaires were identified by a systematic literature search of electronic databases (Medline, Embase, PsychINFO & CINAHL), hand searches (reference sections and PROQOLID database) and expert input. A qualitative analysis was conducted to assess the content and format of the questionnaires and a Venn diagram was produced to illustrate this. Each stage of the review process was conducted by at least two independent reviewers. Results 104 questionnaires fulfilled our criteria. From these, 182 physical activity domains and 1965 items were extracted. Initial qualitative analysis of the domains found 11 categories. Further synthesis of the domains found 4 broad categories: 'physical activity related to general activities and mobility', 'physical activity related to activities of daily living', 'physical activity related to work, social or leisure time activities', and '(disease-specific) symptoms related to physical activity'. The Venn diagram showed that no questionnaires covered all 4 categories and that the '(disease-specific) symptoms related to physical activity' category was often not combined with the other categories. Conclusions A large number of questionnaires with a broad range of physical activity content were identified. Although the content could be broadly organised, there was no consensus on the content and format of physical activity PRO questionnaires in elderly and chronically ill populations. Nevertheless, this systematic review will help investigators to select a physical activity PRO questionnaire that best serves their research question and context. PMID:22414164

  20. 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.

  1. 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.

  2. 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.

  3. Development and Initial Validation of a Patient-Reported Adverse Drug Event Questionnaire

    NARCIS (Netherlands)

    de Vries, Sieta T.; Mol, Peter G. M.; de Zeeuw, Dick; Haaijer-Ruskamp, Flora M.; Denig, Petra

    2013-01-01

    Background Direct patient reporting of adverse drug events (ADEs) is relevant for the evaluation of drug safety. To collect such data in clinical trials and postmarketing studies, a valid questionnaire is needed that can measure all possible ADEs experienced by patients. Objective Our aim was to

  4. The validity of a patient-reported adverse drug event questionnaire using different recall periods

    NARCIS (Netherlands)

    de Vries, Sieta T; Haaijer-Ruskamp, Flora M; de Zeeuw, Dick; Denig, Petra

    2014-01-01

    PURPOSE: To assess the validity of a patient-reported adverse drug events (ADEs) questionnaire with a 3-month or 4-week recall period. METHODS: Patients receiving at least one oral glucose-lowering drug were asked to report potential ADEs they experienced related to any drug in a daily diary for a

  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

    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...

  6. 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.

  7. 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.

  8. 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....

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

    OpenAIRE

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

    2016-01-01

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

  10. Patient-reported 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. 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.

  12. 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...

  13. 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...

  14. 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...

  15. 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.

  16. 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.

  17. 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

  18. 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.

  19. 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.

  20. Development and validation of a patient-reported questionnaire assessing systemic therapy induced diarrhea in oncology patients.

    Science.gov (United States)

    Lui, Michelle; Gallo-Hershberg, Daniela; DeAngelis, Carlo

    2017-12-22

    Systemic therapy-induced diarrhea (STID) is a common side effect experienced by more than half of cancer patients. Despite STID-associated complications and poorer quality of life (QoL), no validated assessment tools exist to accurately assess STID occurrence and severity to guide clinical management. Therefore, we developed and validated a patient-reported questionnaire (STIDAT). The STIDAT was developed using the FDA iterative process for patient-reported outcomes. A literature search uncovered potential items and questions for questionnaire construction used by oncology clinicians to develop questions for the preliminary instrument. The instrument was evaluated on its face validity and content validity by patient interviews. Repetitive, similar and different themes uncovered from patient interviews were implemented to revise the instrument to the version used for validation. Patients starting high-risk STID treatments were monitored using the STIDAT, bowel diaries and EORTC QLQ-C30. The STIDAT was evaluated for construct validity using exploratory factor analysis (EFA) using minimal residual method with Promax rotation, reliability and consistency. A weighted scoring system was developed and a receiver-operating characteristic (ROC) curve evaluated the tool's ability to detect STID occurrence. Median scores and variability were analysed to determine how well it differentiates between diarrhea severities. A post-hoc analysis determined how diarrhea severity impacted QoL of cancer patients. Patients defined diarrhea based on presence of watery stool. The STIDAT assessed patient's perception of having diarrhea, daily number of bowel movements, daily number of diarrhea episodes, antidiarrheal medication use, the presence of urgency, abdominal pain, abdominal spasms or fecal incontinence, patient's perception of diarrhea severity, and QoL. These dimensions were sorted into four clusters using EFA - patient's perception of diarrhea, frequency of diarrhea, fecal

  1. 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.

  2. Patient-reported questionnaires in MS rehabilitation: responsiveness and minimal important difference of the multiple sclerosis questionnaire for physiotherapists (MSQPT).

    Science.gov (United States)

    van der Maas, Nico Arie

    2017-03-16

    The Multiple Sclerosis Questionnaire for Physical Therapists (MSQPT) is a patient-rated outcome questionnaire for evaluating the rehabilitation of persons with multiple sclerosis (MS). Responsiveness was evaluated, and minimal important difference (MID) estimates were calculated to provide thresholds for clinical change for four items, three sections and the total score of the MSQPT. This multicentre study used a combined distribution- and anchor-based approach with multiple anchors and multiple rating of change questions. Responsiveness was evaluated using effect size, standardized response mean (SRM), modified SRM and relative efficiency. For distribution-based MID estimates, 0.2 and 0.33 standard deviations (SD), standard error of measurement (SEM) and minimal detectable change were used . Triangulation of anchor- and distribution-based MID estimates provided a range of MID values for each of the four items, the three sections and the total score of the MSQPT. The MID values were tested for their sensitivity and specificity for amelioration and deterioration for each of the four items, the three sections and the total score of the MSQPT. The MID values of each item and section and of the total score with the best sensitivity and specificity were selected as thresholds for clinical change. The outcome measures were the MSQPT, Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HAQUAMS), rating of change questionnaires, Expanded Disability Status Scale, 6-metre timed walking test, Berg Balance Scale and 6-minute walking test. The effect size ranged from 0.46 to 1.49. The SRM data showed comparable results. The modified SRM ranged from 0.00 to 0.60. Anchor-based MID estimates were very low and were comparable with SD- and SEM-based estimates. The MSQPT was more responsive than the HAQUAMS in detecting improvement but less responsive in finding deterioration. The best MID estimates of the items, sections and total score, expressed in percentage of their

  3. 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.

  4. 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

  5. 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....

  6. Questionnaires for Measuring Refractive Surgery Outcomes.

    Science.gov (United States)

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

    2017-06-01

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

  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. 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...

  9. Patient-reported symptom questionnaires in laryngeal cancer: voice, speech and swallowing.

    Science.gov (United States)

    Rinkel, R N P M; Verdonck-de Leeuw, I M; van den Brakel, N; de Bree, R; Eerenstein, S E J; Aaronson, N; Leemans, C R

    2014-08-01

    To validate questionnaires on voice, speech, and swallowing among laryngeal cancer patients, to assess the need for and use of rehabilitation services, and to determine the association between voice, speech, and swallowing problems, and quality of life and distress. Laryngeal cancer patients at least three months post-treatment completed the VHI (voice), SHI (speech), SWAL-QOL (swallowing), EORTC QLQ-C30, QLQ-HN35, HADS, and study-specific questions on rehabilitation. Eighty-eight patients and 110 healthy controls participated. Cut off scores of 15, 6, and 14 were defined for the VHI, SHI, and SWAL-QOL (sensitivity > 90%; specificity > 80%). Based on these scores, 56% of the patients reported voice, 63% speech, and 54% swallowing problems. VHI, SHI, and SWAL-QOL scores were associated significantly with quality of life (EORTC QLQ-C30 global quality of life scale) (r = .43 (VHI and SHI) and r = .46 (SWAL-QOL)) and distress (r = .50 (VHI and SHI) and r = .58 (SWAL-QOL)). In retrospect, 32% of the patients indicated the need for rehabilitation at time of treatment, and 81% of these patients availed themselves of such services. Post-treatment, 8% of the patients expressed a need for rehabilitation, and 20% of these patients actually made use of such services. Psychometric characteristics of the VHI, SHI, and SWAL-QOL in laryngeal cancer patients are good. The prevalence of voice, speech, and swallowing problems is high, and clearly related to quality of life and distress. Although higher during than after treatment, the perceived need for and use of rehabilitation services is limited. Copyright © 2014 Elsevier Ltd. All rights reserved.

  10. 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.

  11. 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.

  12. 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

  13. 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.

  14. 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...

  15. 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

  16. 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...

  17. 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...

  18. 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....

  19. 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...

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

    Directory of Open Access Journals (Sweden)

    Jones P

    2012-10-01

    instruments do not necessarily have better discriminative or evaluative properties than older instruments. The development of new PRO tools, however, is crucial, not only to ensure that key COPD concepts are being reliably measured but also that the relevant treatment effects are being captured in clinical trials. In turn, this will help us to understand better the patient's experience of the disease.Keywords: patient-reported outcomes, chronic obstructive pulmonary disease, health-related quality of life, questionnaire development, dyspnea, exacerbations

  1. [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.

  2. 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

  3. 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.

  4. 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

  5. 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...

  6. 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

  7. 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

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. 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

  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. 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.

  15. 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

  16. 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.

  17. 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

  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. 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.

  20. 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.

  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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...

  6. 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...

  7. 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.

  8. 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

  9. 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

  10. 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...

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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...

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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.

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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...

  6. 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....

  7. 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...

  8. 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...

  9. 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 .

  10. 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

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

    Science.gov (United States)

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

    2018-04-01

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

  12. 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.

  13. 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.

  14. 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.

  15. 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...

  16. 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

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  1. 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.

  2. 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...

  3. 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...

  4. 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

  5. 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.

  6. 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.

  7. A description of the severity of equestrian-related injuries (ERIs) using clinical parameters and patient-reported outcomes.

    Science.gov (United States)

    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.

  8. 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.

  9. 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

  10. 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.

  11. 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.

  12. 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.

  13. 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

  14. 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

  15. Pixel or Paper? Validation of a Mobile Technology for Collecting Patient-Reported Outcomes in Rheumatoid Arthritis.

    Science.gov (United States)

    Epis, Oscar Massimiliano; Casu, Cinzia; Belloli, Laura; Schito, Emanuela; Filippini, Davide; Muscarà, Marina; Gentile, Maria Giovanna; Perez Cagnone, Paula Carina; Venerelli, Chiara; Sonnati, Massimo; Schiavetti, Irene; Bruschi, Eleonora

    2016-11-16

    In the management of chronic disease, new models for telemonitoring of patients combined with the choice of electronic patient-reported outcomes (ePRO) are being encouraged, with a clear improvement of both patients' and parents' quality of life. An Italian study demonstrated that ePRO were welcome in patients with rheumatoid arthritis (RA), with excellent matching data. The aim of this study is to evaluate the level of agreement between electronic and paper-and-pencil questionnaire responses. This is an observational prospective study. Patients were randomly assigned to first complete the questionnaire by paper and pencil and then by tablet or in the opposite order. The questionnaire consisted of 3 independent self-assessment visual rating scales (Visual Analog Scale, Global Health score, Patient Global Assessment of Disease Activity) commonly used in different adult patients, including those with rheumatic diseases. A total of 185 consecutive RA patients were admitted to hospital and were enrolled and completed the questionnaire both on paper and on electronic versions. For all the evaluated items, the intrarater degree of agreement between 2 approaches was found to be excellent (intraclass correlation coefficient>0.75, P<.001). An electronic questionnaire is uploaded in a dedicated Web-based tool that could implement a telemonitoring system aimed at improving the follow-up of RA patients. High intrarater reliability between paper and electronic methods of data collection encourage the use of a new digital app with consequent benefit for the overall health care system. ©Oscar Massimiliano Epis, Cinzia Casu, Laura Belloli, Emanuela Schito, Davide Filippini, Marina Muscarà, Maria Giovanna Gentile, Paula Carina Perez Cagnone, Chiara Venerelli, Massimo Sonnati, Irene Schiavetti, Eleonora Bruschi. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 16.11.2016.

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  1. 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.

  2. 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...

  3. 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.

  4. 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...

  5. 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

  6. 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...

  7. 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.

  8. 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...

  9. 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

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

    Science.gov (United States)

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

    2015-08-01

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

  11. 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.

  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. 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

  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

    2016-08-01

    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

  17. 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.

  18. 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

  19. 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

  20. 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.

  1. 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.

  2. 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

  3. 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.

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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

  10. Patient-reported outcome instruments that evaluate adherence behaviours in adults with asthma: A systematic review of measurement properties.

    Science.gov (United States)

    Gagné, Myriam; Boulet, Louis-Philippe; Pérez, Norma; Moisan, Jocelyne

    2018-04-30

    To systematically identify the measurement properties of patient-reported outcome instruments (PROs) that evaluate adherence to inhaled maintenance medication in adults with asthma. We conducted a systematic review of six databases. Two reviewers independently included studies on the measurement properties of PROs that evaluated adherence in asthmatic participants aged ≥18 years. Based on the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN), the reviewers (1) extracted data on internal consistency, reliability, measurement error, content validity, structural validity, hypotheses testing, cross-cultural validity, criterion validity, and responsiveness; (2) assessed the methodological quality of the included studies; (3) assessed the quality of the measurement properties (positive or negative); and (4) summarised the level of evidence (limited, moderate, or strong). We screened 6,068 records and included 15 studies (14 PROs). No studies evaluated measurement error or responsiveness. Based on methodological and measurement property quality assessments, we found limited positive evidence of: (a) internal consistency of the Adherence Questionnaire, Refined Medication Adherence Reason Scale (MAR-Scale), Medication Adherence Report Scale for Asthma (MARS-A), and Test of the Adherence to Inhalers (TAI); (b) reliability of the TAI; and (c) structural validity of the Adherence Questionnaire, MAR-Scale, MARS-A, and TAI. We also found limited negative evidence of: (d) hypotheses testing of Adherence Questionnaire; (e) reliability of the MARS-A; and (f) criterion validity of the MARS-A and TAI. Our results highlighted the need to conduct further high-quality studies that will positively evaluate the reliability, validity, and responsiveness of the available PROs. This article is protected by copyright. All rights reserved.

  11. 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

  12. The Computer-based Health Evaluation Software (CHES: a software for electronic patient-reported outcome monitoring

    Directory of Open Access Journals (Sweden)

    Holzner Bernhard

    2012-11-01

    Full Text Available Abstract Background Patient-reported Outcomes (PROs capturing e.g., quality of life, fatigue, depression, medication side-effects or disease symptoms, have become important outcome parameters in medical research and daily clinical practice. Electronic PRO data capture (ePRO with software packages to administer questionnaires, storing data, and presenting results has facilitated PRO assessment in hospital settings. Compared to conventional paper-pencil versions of PRO instruments, ePRO is more economical with regard to staff resources and time, and allows immediate presentation of results to the medical staff. The objective of our project was to develop software (CHES – Computer-based Health Evaluation System for ePRO in hospital settings and at home with a special focus on the presentation of individual patient’s results. Methods Following the Extreme Programming development approach architecture was not fixed up-front, but was done in close, continuous collaboration with software end users (medical staff, researchers and patients to meet their specific demands. Developed features include sophisticated, longitudinal charts linking patients’ PRO data to clinical characteristics and to PRO scores from reference populations, a web-interface for questionnaire administration, and a tool for convenient creating and editing of questionnaires. Results By 2012 CHES has been implemented at various institutions in Austria, Germany, Switzerland, and the UK and about 5000 patients participated in ePRO (with around 15000 assessments in total. Data entry is done by the patients themselves via tablet PCs with a study nurse or an intern approaching patients and supervising questionnaire completion. Discussion During the last decade several software packages for ePRO have emerged for different purposes. Whereas commercial products are available primarily for ePRO in clinical trials, academic projects have focused on data collection and presentation in daily

  13. 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.

  14. 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.

  15. 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

  16. 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.

  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. 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.

  20. 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.

  1. 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.

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

    Science.gov (United States)

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

    2018-07-01

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

  3. 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.

  4. Development and content validity of a patient reported outcomes measure to assess symptoms of major depressive disorder

    Directory of Open Access Journals (Sweden)

    Lasch Kathryn

    2012-04-01

    Full Text Available Abstract Background Although many symptoms of Major Depressive Disorder (MDD are assessed through patient-report, there are currently no patient-reported outcome (PRO instruments that incorporate documented evidence of patient input in PRO instrument development. A review of existing PROs used in MDD suggested the need to conduct qualitative research with patients with MDD to better understand their experience of MDD and develop an evaluative instrument with content validity. The aim of this study was to develop a disease-specific questionnaire to assess symptoms important and relevant to adult MDD patients. Methods The questionnaire development involved qualitative interviews for concept elicitation, instrument development, and cognitive interviews to support content validity. For concept elicitation, ten MDD severity-specific focus group interviews with thirty-eight patients having clinician-confirmed diagnoses of MDD were conducted in January 2009. A semi-structured discussion guide was used to elicit patients' spontaneous descriptions of MDD symptoms. Verbatim transcripts of focus groups were coded and analyzed to develop a conceptual framework to describe MDD. A PRO instrument was developed by operationalizing concepts elicited in the conceptual framework. Cognitive interviews were carried out in patients (n = 20 to refine and test the content validity of the instrument in terms of item relevance and comprehension, instructions, recall period, and response categories. Results Concept elicitation focus groups identified thirty-five unique concepts falling into several domains: i emotional, ii cognitive, iii motivation, iv work, v sleep, vi appetite, vii social, viii activities of daily living, ix tired/fatigue, x body pain, and xi suicidality. Concept saturation, the point at which no new relevant information emerges in later interviews, was achieved for each of the concepts. Based on the qualitative findings, the PRO instrument developed

  5. 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.

  6. 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.

  7. 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.

  8. [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.

  9. 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.

  10. 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

  11. 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%.

  12. Validation of Patient-Reported Outcomes Measurement Information System Short Forms for Use in Childhood-Onset Systemic Lupus Erythematosus.

    Science.gov (United States)

    Jones, Jordan T; Carle, Adam C; Wootton, Janet; Liberio, Brianna; Lee, Jiha; Schanberg, Laura E; Ying, Jun; Morgan DeWitt, Esi; Brunner, Hermine I

    2017-01-01

    To validate the pediatric Patient-Reported Outcomes Measurement Information System short forms (PROMIS-SFs) in childhood-onset systemic lupus erythematosus (SLE) in a clinical setting. At 3 study visits, childhood-onset SLE patients completed the PROMIS-SFs (anger, anxiety, depressive symptoms, fatigue, physical function-mobility, physical function-upper extremity, pain interference, and peer relationships) using the PROMIS assessment center, and health-related quality of life (HRQoL) legacy measures (Pediatric Quality of Life Inventory, Childhood Health Assessment Questionnaire, Simple Measure of Impact of Lupus Erythematosus in Youngsters [SMILEY], and visual analog scales [VAS] of pain and well-being). Physicians rated childhood-onset SLE activity on a VAS and completed the Systemic Lupus Erythematosus Disease Activity Index 2000. Using a global rating scale of change (GRC) between study visits, physicians rated change of childhood-onset SLE activity (GRC-MD1: better/same/worse) and change of patient overall health (GRC-MD2: better/same/worse). Questionnaire scores were compared in support of validity and responsiveness to change (external standards: GRC-MD1, GRC-MD2). In this population-based cohort (n = 100) with a mean age of 15.8 years (range 10-20 years), the PROMIS-SFs were completed in less than 5 minutes in a clinical setting. The PROMIS-SF scores correlated at least moderately (Pearson's r ≥ 0.5) with those of legacy HRQoL measures, except for the SMILEY. Measures of childhood-onset SLE activity did not correlate with the PROMIS-SFs. Responsiveness to change of the PROMIS-SFs was supported by path, mixed-model, and correlation analyses. To assess HRQoL in childhood-onset SLE, the PROMIS-SFs demonstrated feasibility, internal consistency, construct validity, and responsiveness to change in a clinical setting. © 2016, American College of Rheumatology.

  13. Clinical and patient-reported outcomes of bilateral implantation of a +2.5 diopter multifocal intraocular lens.

    Science.gov (United States)

    Maxwell, Andrew; Holland, Edward; Cibik, Lisa; Fakadej, Anna; Foster, Gary; Grosinger, Les; Moyes, Andrew; Nielsen, Stephen; Silverstein, Steven; Toyos, Melissa; Weinstein, Arthur; Hartzell, Scott

    2017-01-01

    To assess the effectiveness and safety of a multifocal intraocular lens (IOL) with +2.5 diopter (D) additional power compared with a monofocal IOL. Fifteen sites in the United States. Prospective randomized patient- and observer-masked clinical trial. Randomized patients received multifocal or monofocal IOLs bilaterally. Visual acuity (33 cm, 40 cm, 53 cm, 60 cm, 4 m) was measured; safety was assessed through adverse event rates. Patient-reported visual outcomes were evaluated using the Visual Tasks questionnaire. The frequency and severity of visual disturbances were evaluated using the Assessment of Photic Phenomena and Lens EffectS questionnaire. The multifocal IOL (n = 155) provided better corrected distance visual acuity at 53 cm than the monofocal IOL (n = 165) (0.322 versus 0.512 logMAR; between-group difference, -0.190 logMAR; P < .0001) and 40 cm but not at 4 m. Ocular adverse event rates were less than 3.84% in both groups. Serious adverse event rates were comparable between the 2 IOL types. Patients with multifocal IOLs reported less difficulty with near tasks (with and without correction) and intermediate tasks (without correction). Difficulty with extended-intermediate and distance tasks was similar between groups. The most frequently reported self-rated severe phenomena were halos, starbursts, and glare. Most patients (monofocal ≥72%; multifocal ≥73%) reported never experiencing blurred, distorted, or double vision. The +2.5 D multifocal IOL provided better vision at 40 cm and 53 cm and similar vision at 4 m compared with the monofocal IOL. Safety profiles and visual phenomena were comparable between groups. Copyright © 2017 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

  14. Does routinely collected patient-reported outcome data represent the actual case-mix of elective coronary revascularization patients?

    Science.gov (United States)

    Oinasmaa, Salla; Heiskanen, Jari; Hartikainen, Juha; Hippeläinen, Mikko; Miettinen, Heikki; Martikainen, Janne; Roine, Risto P; Tolppanen, Anna-Maija

    2018-04-01

    Patient-reported outcomes (PROs) are valuable for effectiveness evaluation, but it is unknown whether the patient views obtained represent the actual case mix. We studied the representativeness of the responses obtained to a routinely administered health-related quality of life (HRQoL) questionnaire in a cardiology unit. Elective coronary artery bypass grafting (CABG; n = 404) and percutaneous coronary intervention (PCI; n = 738) patients operated during June 2012 to August 2014 in the Heart Center, Kuopio University Hospital. The characteristics of the patients with a baseline (n = 260 and 290 for CABG and PCI, respectively) or both baseline and follow-up HRQoL measurements (n = 203 and 189 for CABG and PCI, respectively) were compared with those who did not respond (n = 144 and 448 for CABG and PCI). Baseline questionnaires were less likely obtained from older CABG patients (odds ratio 0.51, 95% confidence interval 0.28-0.91) and those with more severe disease (0.20, 0.05-0.79). Among PCI patients, women (0.64, 0.45-0.91), smokers (0.74, 0.53-1.04), and those with more severe disease (0.26, 0.13-0.52) or more hospital days were underrepresented. Routinely collected PROs in cardiac patients may be biased towards younger and healthier patients. This needs to be recognized when evaluating the representativeness of such data. The routine collection of these data should be adequately resourced.

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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....

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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

  7. 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.

  8. 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

  9. 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.

  10. [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.

  11. 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

  12. 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.

  13. 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.

  14. 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.

  15. 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

  16. 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.

  17. 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

  18. 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

  19. An Examination of the "Interpersonalness" of the Outcome Questionnaire

    Science.gov (United States)

    Hess, Timothy R.; Rohlfing, Jessica E.; Hardy, Amanda O.; Glidden-Tracey, Cynthia; Tracey, Terence J. G.

    2010-01-01

    This study examined whether the Outcome Questionnaire-45 (OQ) and its subscales assessed unique interpersonal distress. The Inventory of Interpersonal Problems (IIP) was used to assess discriminant validity for unique interpersonal distress. Participants (N = 121) were recruited from a southwestern university counselor training center. Significant…

  20. 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.

  1. 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

  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. Psychometric validation of the dysmenorrhea daily diary (DysDD): a patient-reported outcome for dysmenorrhea.

    Science.gov (United States)

    Nguyen, Allison M; Arbuckle, Rob; Korver, Tjeerd; Chen, Fang; Taylor, Beverley; Turnbull, Alice; Norquist, Josephine M

    2017-08-01

    The objective of this study was to evaluate the psychometric properties of the Dysmenorrhea Daily Diary (DysDD), an electronic patient-reported outcome, in a sample of 355 women with primary dysmenorrhea enrolled in a phase IIb, multicenter, randomized, partially blinded, placebo-controlled trial for treatment of dysmenorrhea. Subjects completed the DysDD over three menstrual cycles, one pre-treatment baseline cycle and two treatment cycles. The DysDD was administered alongside the Menstrual Distress Questionnaire (MDQ), the Short-Form 36 Version 2.0 (SF-36v2), and a Global Assessment of Change (GAC). Item response distributions, test-retest reliability, concurrent and known groups validity, responsiveness, and minimally important difference (MID) were evaluated for the DysDD. As expected, item response distributions varied throughout the menstrual period for all items, with the response scales fully utilized. Within-cycle test-retest reliability was adequate (weighted kappa: 0.5-0.7), although between-cycle test-retest was poor (weighted kappa: 0.1-0.5), most likely due to the highly variable nature of dysmenorrhea between cycles rather than limitations of the measure. Correlations with the MDQ and SF-36v2 were low-moderate, but in the predicted direction, supporting concurrent validity. There were significant differences in DysDD scores across severity groups based on pain medication use. The DysDD was responsive to changes in patients' dysmenorrhea with significantly different changes in scores between change groups (p dysmenorrhea.

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

    Science.gov (United States)

    Chen, Michael; Mangubat, Erwin; Ouyang, Bichun

    2016-01-01

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

  10. Development and validation of a primary sclerosing cholangitis-specific patient-reported outcomes instrument: The PSC PRO.

    Science.gov (United States)

    Younossi, Zobair M; Afendy, Arian; Stepanova, Maria; Racila, Andrei; Nader, Fatema; Gomel, Rachel; Safer, Ricky; Lenderking, William R; Skalicky, Anne; Kleinman, Leah; Myers, Robert P; Subramanian, G Mani; McHutchison, John G; Levy, Cynthia; Bowlus, Christopher L; Kowdley, Kris; Muir, Andrew J

    2017-11-20

    Primary sclerosing cholangitis (PSC) is a chronic liver disease associated with inflammation and biliary fibrosis that leads to cholangitis, cirrhosis, and impaired quality of life. Our objective was to develop and validate a PSC-specific patient-reported outcome (PRO) instrument. We developed a 42-item PSC PRO instrument that contains two modules (Symptoms and Impact of Symptoms) and conducted an external validation. Reliability and validity were evaluated using clinical data and a battery of other validated instruments. Test-retest reliability was assessed in a subgroup of patients who repeated the PSC PRO after the first administration. One hundred two PSC subjects (44 ± 13 years; 32% male, 74% employed, 39% with cirrhosis, 14% with a history of decompensated cirrhosis, 38% history of depression, and 68% with inflammatory bowel disease [IBD]) completed PSC PRO and other PRO instruments (Short Form 36 V2 [SF-36], Chronic Liver Disease Questionnaire [CLDQ], Primary Biliary Cholangitis - 40 [PBC-40], and five dimensions [5-D Itch]). PSC PRO demonstrated excellent internal consistency (Cronbach alphas, 0.84-0.94) and discriminant validity (41 of 42 items had the highest correlations with their own domains). There were good correlations between PSC PRO domains and relevant domains of SF-36, CLDQ, and PBC-40 (R = 0.69-0.90; all P 0.05). Test-retest reliability was assessed in 53 subjects who repeated PSC PRO within a median (interquartile range) of 37 (27-47) days. There was excellent reliability for most domains with intraclass correlations (0.71-0.88; all P < 0.001). PSC PRO is a self-administered disease-specific instrument developed according to U.S. Food and Drug Administration guidelines. This preliminary validation study suggests good psychometric properties. Further validation of the instrument in a larger and more diverse sample of PSC patients is needed. (Hepatology 2017). © 2017 by the American Association for the Study of Liver Diseases.

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

    Science.gov (United States)

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

    2017-01-01

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

  12. Comparison of patient-reported outcomes between immediately and conventionally loaded mandibular two-implant overdentures: A preliminary study.

    Science.gov (United States)

    Omura, Yuri; Kanazawa, Manabu; Sato, Daisuke; Kasugai, Shohei; Minakuchi, Shunsuke

    2016-07-01

    The aim of this preliminary study is to compare patient-reported outcomes between immediately and conventionally loaded mandibular two-implant overdentures retained by magnetic attachments. Nineteen participants with edentulous mandibles were randomly assigned into either an immediate loading group (immediate group) or a conventional loading group (conventional group). Each participant received 2 implants in the inter-foraminal region by means of flapless surgery. Prostheses in the immediate and conventional groups were loaded using magnetic attachments on the same day as implant placement or 3 months after surgery, respectively. All participants completed questionnaires (the Japanese version of the Oral Health Impact Profile for edentulous [OHIP-EDENT-J], the patient's denture assessment [PDA], and general satisfaction) before implant placement (baseline) and 1, 2, 3, 4, 5, 6, and 12 months after surgery. The median differences between baseline and each monthly score were compared using the Mann-Whitney U test. The differences in median and 95% confidence interval between two groups were analyzed. The immediate group showed slightly lower OHIP-EDENT-J summary score at 1 and 3 months than the conventional group (P=0.09). In the lower denture domain of PDA, the immediate group showed a statistically higher score at 3 months (P=0.04). There was no statistically significant difference in general satisfaction between the two groups. Based on this preliminary study, immediate loading of mandibular two-implant overdentures with magnetic attachments tends to improve oral health-related quality of life and patient assessment earlier than observed with a conventional loading protocol. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  13. Psychometric Characteristics of a Patient Reported Outcome Measure on Ego-Integrity and Despair among Cancer Patients.

    Directory of Open Access Journals (Sweden)

    Gitta Kleijn

    Full Text Available To evaluate psychometric characteristics of a questionnaire (the Northwestern Ego-integrity Scale (NEIS on ego-integrity (the experience of wholeness and meaning in life, even in spite of negative experiences and despair (the experience of regret about the life one has led, and feelings of sadness, failure and hopelessness among cancer patients.Cancer patients (n = 164 completed patient reported outcome measures on ego-integrity and despair (NEIS, psychological distress, anxiety and depression (Hospital Anxiety and Depression Scale (HADS, and quality of life (EORTC QLQ-C30 (cancer survivors, n = 57 or EORTC QLQ-C15-PAL (advanced cancer patients, n = 107. Confirmatory Factor Analysis was used to assess construct validity. Cronbach's alpha was used to assess internal consistency. Convergent validity was tested based on a priori defined hypotheses: a higher level of ego-integrity was expected to be related to a higher level of quality of life, and lower levels of distress, depression and anxiety; a higher level of despair was expected to be related to a lower level of quality of life, and higher levels of distress, depression and anxiety.The majority of all items (94.5% of the NEIS were completed by patients and single item missing rate was below 2%. The two subscales, labeled as Ego-integrity (5 items and Despair (4 items had acceptable internal consistency (Cronbach's alpha .72 and .61, respectively. The Ego-integrity subscale was not significantly associated with quality of life, distress, anxiety, or depression. The Despair subscale correlated significantly (p <.001 with quality of life (r = -.29, distress (r = .44, anxiety (r = .47 and depression (r = .32.The NEIS has good psychometric characteristics to assess ego-integrity and despair among cancer patients.

  14. Patients' perception of postoperative pain management: validation of the International Pain Outcomes (IPO) questionnaire.

    Science.gov (United States)

    Rothaug, Judith; Zaslansky, Ruth; Schwenkglenks, Matthias; Komann, Marcus; Allvin, Renée; Backström, Ragnar; Brill, Silviu; Buchholz, Ingo; Engel, Christoph; Fletcher, Dominique; Fodor, Lucian; Funk, Peter; Gerbershagen, Hans J; Gordon, Debra B; Konrad, Christoph; Kopf, Andreas; Leykin, Yigal; Pogatzki-Zahn, Esther; Puig, Margarita; Rawal, Narinder; Taylor, Rod S; Ullrich, Kristin; Volk, Thomas; Yahiaoui-Doktor, Maryam; Meissner, Winfried

    2013-11-01

    PAIN OUT is a European Commission-funded project aiming at improving postoperative pain management. It combines a registry that can be useful for quality improvement and research using treatment and patient-reported outcome measures. The core of the project is a patient questionnaire-the International Pain Outcomes questionnaire-that comprises key patient-level outcomes of postoperative pain management, including pain intensity, physical and emotional functional interference, side effects, and perceptions of care. Its psychometric quality after translation and adaptation to European patients is the subject of this validation study. The questionnaire was administered to 9,727 patients in 10 languages in 8 European countries and Israel. Construct validity was assessed using factor analysis. Discriminant validity assessment used Mann-Whitney U tests to detect mean group differences between 2 surgical disciplines. Internal consistency reliability was calculated as Cronbach's alpha. Factor analysis resulted in a 3-factor structure explaining 53.6% of variance. Cronbach's alpha at overall scale level was high (.86), and for the 3 subscales was low, moderate, or high (range, .53-.89). Significant mean group differences between general and orthopedic surgery patients confirmed discriminant validity. The psychometric quality of the International Pain Outcomes questionnaire can be regarded as satisfactory. The International Pain Outcomes questionnaire provides an instrument for postoperative pain assessment and improvement of quality of care, which demonstrated good psychometric quality when translated into a variety of languages in a large European and Israeli patient population. This measure provides the basis for the first comprehensive postoperative pain registry in Europe and other countries. Copyright © 2013. Published by Elsevier Inc.

  15. Cultural adaptation: translatability assessment and linguistic validation of the patient-reported outcome instrument for irritable bowel syndrome with diarrhea

    Directory of Open Access Journals (Sweden)

    Delgado-Herrera L

    2016-06-01

    Full Text Available Leticia Delgado-Herrera,1 Kathryn Lasch,2 Ana Popielnicki,3 Akito Nishida,4 Rob Arbuckle,5 Benjamin Banderas,6 Susan Zentner,1 Ingrid Gagainis,1 Bernhardt Zeiher1 1Astellas Pharma Global Development, Northbrook, IL, 2Pharmerit International, Newton, MA, USA; 3TransPerfect, Linguistic Validation Group, Boston, MA, USA; 4Development Project Management, Astellas Pharma Inc, Tokyo, Japan; 5Patient-Centered Outcomes Adelphi Values, Bollington, UK; 6Patient-Centered Outcomes Adelphi Values, Boston, MA, USA Background and objective: Following a 2009 US Food and Drug Administration guidance, a new patient-reported outcome (PRO instrument was developed to support end points in multinational clinical trials assessing irritable bowel syndrome with diarrhea (IBS-D symptom severity. Our objective was to assess the translatability of the IBS-D PRO instrument into ten languages, and subsequently perform a cultural adaptation/linguistic validation of the questionnaire into Japanese and US Spanish. Materials and methods: Translatability assessments of the US English version of the IBS-D PRO were performed by experienced PRO translators who were native speakers of each target language and currently residing in target-language countries. Languages were Chinese (People’s Republic of China, Dutch (the Netherlands, French (Belgium, German (Germany, Japanese (Japan, Polish (Poland, Portuguese (Brazil, Russian (Russia, Spanish (Mexico, and Spanish (US. The project team assessed the instrument to identify potential linguistic and/or cultural adaptation issues. After the issues identified were resolved, the instrument was translated into Spanish (US and Japanese through a process of two forward translations, one reconciled translation, and one backward translation. The project team reviewed the translated versions before the instruments were evaluated by cognitive debriefing interviews with samples of five Spanish (US and five Japanese IBS-D patients. Results

  16. Implementing patient-reported outcome measures in palliative care clinical practice: a systematic review of facilitators and barriers.

    Science.gov (United States)

    Antunes, Bárbara; Harding, Richard; Higginson, Irene J

    2014-02-01

    Many patient-reported outcome measures have been developed in the past two decades, playing an increasingly important role in palliative care. However, their routine use in practice has been slow and difficult to implement. To systematically identify facilitators and barriers to the implementation of patient-reported outcome measures in different palliative care settings for routine practice, and to generate evidence-based recommendations, to inform the implementation process in clinical practice. Systematic literature review and narrative synthesis. Medline, PsycInfo, Cumulative Index to Nursing and Allied Health Literature, Embase and British Nursing Index were systematically searched from 1985. Hand searching of reference lists for all included articles and relevant review articles was performed. A total of 3863 articles were screened. Of these, 31 articles met the inclusion criteria. First, data were integrated in the main themes: facilitators, barriers and lessons learned. Second, each main theme was grouped into either five or six categories. Finally, recommendations for implementation on outcome measures at management, health-care professional and patient levels were generated for three different points in time: preparation, implementation and assessment/improvement. Successful implementation of patient-reported outcome measures should be tailored by identifying and addressing potential barriers according to setting. Having a coordinator throughout the implementation process seems to be key. Ongoing cognitive and emotional processes of each individual should be taken into consideration during changes. The educational component prior to the implementation is crucial. This could promote ownership and correct use of the measure by clinicians, potentially improving practice and the quality of care provided through patient-reported outcome measure data use in clinical decision-making.

  17. Patient-Reported Outcome Coordinator Did Not Improve Quality of Life Assessment Response Rates: A Report from the Children's Oncology Group.

    Directory of Open Access Journals (Sweden)

    Donna Johnston

    Full Text Available Health related quality of life (HRQL assessments during therapy for pediatric cancer provide valuable information to better understand the patient experience. Our objective was to determine the impact of a patient-reported outcome (PRO coordinator on HRQL questionnaire completion rates during a pediatric acute myeloid leukemia (AML trial.AAML1031 is a multicenter Children's Oncology Group therapeutic trial for de novo AML with a secondary aim to assess HRQL of children and adolescents treated with chemotherapy and hematopoietic stem cell transplantation (HSCT. Parents/guardians are the primary respondents and four questionnaires are administered at eight time points. The questionnaires are the PedsQL 4.0 Generic Core Scales, PedsQL 3.0 Acute Cancer Module, PedsQL Multidimensional Fatigue Scale, and the Pediatric Inventory for Parents. To improve response rates, a central PRO coordinator was instituted and reminded sites about upcoming and delinquent questionnaires. The proportion of HRQL questionnaires completed were compared prior to, and following institution of the PRO coordinator. This analysis evaluated the first five assessment time points.There were231 families who consented to participate in the HRQL aim. Overall response rates for all questionnaires were 73-83%. At time point 1, within 14 days of chemotherapy initiation, post-PRO coordinator completion rates were significantly higher for three of four questionnaires. However, the effect was not sustained and at time point 4, one month following last chemotherapy or HSCT, completion rates were significantly lower post-PRO coordinator for all four questionnaires.Addition of a central PRO coordinator did not result in sustained improvement in HRQL questionnaire completion rates. Efforts to improve response rates must consider other strategies.

  18. 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....

  19. 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...

  20. 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.

  1. 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...

  2. Development and validation of a novel patient-reported treatment satisfaction measure for hyperfunctional facial lines: facial line satisfaction questionnaire.

    Science.gov (United States)

    Pompilus, Farrah; Burgess, Somali; Hudgens, Stacie; Banderas, Benjamin; Daniels, Selena

    2015-12-01

    Facial lines or wrinkles are among the most visible signs of aging, and minimally invasive cosmetic procedures are becoming increasingly popular. The aim of this study was to develop and validate the Facial Line Satisfaction Questionnaire (FLSQ) for use in adults with upper facial lines (UFL). A literature review, concept elicitation interviews (n = 33), and cognitive debriefing interviews (n = 23) of adults with UFL were conducted to develop the FLSQ. The FLSQ comprises Baseline and Follow-up versions and was field-tested with 150 subjects in a US observational study designed to assess its psychometric performance. Analyses included acceptability (item and scale distribution [i.e. missingness, floor, and ceiling effects]), reliability, and validity (including concurrent validity). In total, 69 concepts were elicited during patient interviews. Following cognitive debriefing interviews, the FLSQ-Baseline version included 11 items and the Follow-up version included 13 items. Response rates for the FLSQ were 100% and 73% at baseline and follow-up, respectively; no items had excessive missing data. Questionnaire scale scores were normally distributed. Most domain scores demonstrated good internal consistency reliability (Cronbach's α ≥ 0.70). Most items within their respective domains exhibited good convergent (item-scale correlations > 0.40) and discriminant (items had higher correlation with their hypothesized scales than other scales) validity. Concurrent validity correlation coefficients of the FLSQ domain scores with the associated concurrent measures were acceptable (range: r = 0.40-0.70). Six FLSQ items demonstrated reliability and validity as stand-alone items outside their domains. The FLSQ is a valid questionnaire for assessing treatment expectations, satisfaction, impact, and preference in adults with UFL. © 2015 The Authors. Journal of Cosmetic Dermatology Published by Wiley Periodicals, Inc.

  3. A new internet-based tool for reporting and analysing patient-reported outcomes and the feasibility of repeated data collection from patients with myeloproliferative neoplasms.

    Science.gov (United States)

    Brochmann, Nana; Zwisler, Ann-Dorthe; Kjerholt, Mette; Flachs, Esben Meulengracht; Hasselbalch, Hans Carl; Andersen, Christen Lykkegaard

    2016-04-01

    An Internet-based tool for reporting and analysing patient-reported outcomes (PROs) has been developed. The tool enables merging PROs with blood test results and allows for computation of treatment responses. Data may be visualized by graphical analysis and may be exported for downstream statistical processing. The aim of this study was to investigate, whether patients with myeloproliferative neoplasms (MPNs) were willing and able to use the tool and fill out questionnaires regularly. Participants were recruited from the outpatient clinic at the Department of Haematology, Roskilde University Hospital, Denmark. Validated questionnaires that were used were European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, Myeloproliferative Neoplasm Symptom Assessment Form, Brief Fatigue Inventory and Short Form 36 Health Survey. Questionnaires were filled out ≥ 6 months online or on paper according to participant preference. Regularity of questionnaire submission was investigated, and participant acceptance was evaluated by focus-group interviews. Of 135 invited patients, 118 (87 %) accepted participation. One hundred and seven participants (91 %) preferred to use the Internet-based tool. Of the 118 enrolled participants, 104 (88 %) submitted PROs regularly ≥ 6 months. The focus-group interviews revealed that the Internet-based tool was well accepted. The Internet-based approach and regular collection of PROs are well accepted with a high participation rate, persistency and adherence in a population of MPN patients. The plasticity of the platform allows for adaptation to patients with other medical conditions.

  4. 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

  5. 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.

  6. Patient-Reported Outcomes following Breast Conservation Therapy and Barriers to Referral for Partial Breast Reconstruction.

    Science.gov (United States)

    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.

  7. 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.

  8. 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

  9. Patient-reported outcomes of therapy with two brands of ibuprofen

    Directory of Open Access Journals (Sweden)

    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.

  10. 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

  11. A prospective study of the feasibility and acceptability of a Web-based, electronic patient-reported outcome system in assessing patient recovery after major gynecologic cancer surgery.

    Science.gov (United States)

    Andikyan, Vaagn; Rezk, Youssef; Einstein, M Heather; Gualtiere, Gina; Leitao, Mario M; Sonoda, Yukio; Abu-Rustum, Nadeem R; Barakat, Richard R; Basch, Ethan M; Chi, Dennis S

    2012-11-01

    The purposes of this study are to evaluate the feasibility of capturing patient-reported outcomes (PROs) electronically and to identify the most common distressing symptoms in women recovering from major gynecologic cancer surgery. This was a prospective, single-arm pilot study. Eligible participants included those scheduled for a laparotomy for presumed or known gynecologic malignancy. Patients completed a Web-based "STAR" (Symptom Tracking and Reporting for Patients) questionnaire once preoperatively and weekly during the 6-week postoperative period. The questionnaire consisted of the patient adaptation of the NCI CTCAE 3.0 and EORTC QLQ-C30 3.0. When a patient submitted a response that was concerning, an automated email alert was sent to the clinician. The patient's assessment of STAR's usefulness was measured via an exit survey. Forty-nine patients completed the study. The procedures included the following: hysterectomy±staging (67%), resection of tumor (22%), salpingo-oophorectomy (6%), and other (4%). Most patients (82%) completed at least 4 sessions in STAR. The CTC generated 43 alerts. These alerts resulted in 25 telephone contacts with patients, 2 ER referrals, one new appointment, and one pharmaceutical prescription. The 3 most common patient-reported symptoms generating an alert were as follows: poor performance status (19%), nausea (18%), and fatigue (17%). Most patients found STAR useful (80%) and would recommend it to others (85%). Application of a Web-based, electronic STAR system is feasible in the postoperative period, highly accepted by patients, and warrants further study. Poor performance status, nausea, and fatigue were the most common distressing patient-reported symptoms. Copyright © 2012 Elsevier Inc. All rights reserved.

  12. 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...

  13. 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

  14. Patient-reported outcomes in adults with congenital heart disease: Inter-country variation, standard of living and healthcare system factors.

    Science.gov (United States)

    Moons, Philip; Kovacs, Adrienne H; Luyckx, Koen; Thomet, Corina; Budts, Werner; Enomoto, Junko; Sluman, Maayke A; Yang, Hsiao-Ling; Jackson, Jamie L; Khairy, Paul; Cook, Stephen C; Subramanyan, Raghavan; Alday, Luis; Eriksen, Katrine; Dellborg, Mikael; Berghammer, Malin; Johansson, Bengt; Mackie, Andrew S; Menahem, Samuel; Caruana, Maryanne; Veldtman, Gruschen; Soufi, Alexandra; Fernandes, Susan M; White, Kamila; Callus, Edward; Kutty, Shelby; Van Bulck, Liesbet; Apers, Silke

    2018-01-15

    Geographical differences in patient-reported outcomes (PROs) of adults with congenital heart disease (ConHD) have been observed, but are poorly understood. We aimed to: (1) investigate inter-country variation in PROs in adults with ConHD; (2) identify patient-related predictors of PROs; and (3) explore standard of living and healthcare system characteristics as predictors of PROs. Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease - International Study (APPROACH-IS) was a cross-sectional, observational study, in which 4028 patients from 15 countries in 5 continents were enrolled. Self-report questionnaires were administered: patient-reported health (12-item Short Form Health Survey; EuroQOL-5D Visual Analog Scale); psychological functioning (Hospital Anxiety and Depression Scale); health behaviors (Health Behavior Scale-Congenital Heart Disease) and quality of life (Linear Analog Scale for quality of life; Satisfaction With Life Scale). A composite PRO score was calculated. Standard of living was expressed as Gross Domestic Product per capita and Human Development Index. Healthcare systems were operationalized as the total health expenditure per capita and the overall health system performance. Substantial inter-country variation in PROs was observed, with Switzerland having the highest composite PRO score (81.0) and India the lowest (71.3). Functional class, age, and unemployment status were patient-related factors that independently and consistently predicted PROs. Standard of living and healthcare system characteristics predicted PROs above and beyond patient characteristics. This international collaboration allowed us to determine that PROs in ConHD vary as a function of patient-related factors as well as the countries in which patients live. Copyright © 2017 Elsevier B.V. All rights reserved.

  15. 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.

  16. 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...

  17. 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.

  18. Patient-reported outcomes at hospital discharge from Heart Centres, a national cross-sectional survey with a register-based follow-up

    DEFF Research Database (Denmark)

    Berg, Selina Kikkenborg; Svanholm, Jette; Lauberg, Astrid

    2014-01-01

    Introduction: Patient reported health status, which includes symptom burden, functional status and quality of life, is an important measure of health. Differences in health status between diagnostic groups within cardiology have only been sparsely investigated. These outcomes may predict morbidity...... in national registers. The following instruments are used: SF-12, Hospital Anxiety and Depression Scale, EQ-5D, Brief Illness Perception Questionnaire (B-IPQ), HeartQoL and Edmonton Symptom Assessment Scale. The following variables are collected from national registers: action diagnosis, procedures......, comorbidity, length of hospital stay, type of hospitalisation, visits to general practitioners and other agents in primary healthcare, dispensed prescription medication, vital status and cause of death. Labour market affiliation, sick leave, early retirement pension, educational degree and income...

  19. Patient-reported outcomes instruments: bridging the gap between international copyright laws and common practice for developers and users--a case example.

    Science.gov (United States)

    Anfray, Caroline

    2009-12-01

    Copyright laws are intended to protect the rights of authors in their literary, scientific, and artistic works. The recent controversy about the standardized version of the Asthma Quality of Life Questionnaire between Elizabeth Juniper and Eirini Grammatopoulou et al. is an example of the difficulties inherent to copyright faced by developers and users of patient-reported outcome (PRO) instruments. This brief communication presents the basics of international copyright laws (i.e., the Berne Convention), the facts behind the controversy, and our analysis of the case based on our experience as a distributing center of PRO instruments. We conclude that better communication between developers and users would prevent most unfortunate complications and misunderstandings.

  20. 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...

  1. 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.

  2. 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.

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

    Science.gov (United States)

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

    2016-06-20

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

  4. 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

  5. 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

  6. Thalamic Functional Connectivity in Mild Traumatic Brain Injury: Longitudinal Associations With Patient-Reported Outcomes and Neuropsychological Tests.

    Science.gov (United States)

    Banks, Sarah D; Coronado, Rogelio A; Clemons, Lori R; Abraham, Christine M; Pruthi, Sumit; Conrad, Benjamin N; Morgan, Victoria L; Guillamondegui, Oscar D; Archer, Kristin R

    2016-08-01

    (1) To examine differences in patient-reported outcomes, neuropsychological tests, and thalamic functional connectivity (FC) between patients with mild traumatic brain injury (mTBI) and individuals without mTBI and (2) to determine longitudinal associations between changes in these measures. Prospective observational case-control study. Academic medical center. A sample (N=24) of 13 patients with mTBI (mean age, 39.3±14.0y; 4 women [31%]) and 11 age- and sex-matched controls without mTBI (mean age, 37.6±13.3y; 4 women [36%]). Not applicable. Resting state FC (3T magnetic resonance imaging scanner) was examined between the thalamus and the default mode network, dorsal attention network, and frontoparietal control network. Patient-reported outcomes included pain (Brief Pain Inventory), depressive symptoms (Patient Health Questionnaire-9), posttraumatic stress disorder ([PTSD] Checklist - Civilian Version), and postconcussive symptoms (Rivermead Post-Concussion Symptoms Questionnaire). Neuropsychological tests included the Delis-Kaplan Executive Function System Tower test, Trails B, and Hotel Task. Assessments occurred at 6 weeks and 4 months after hospitalization in patients with mTBI and at a single visit for controls. Student t tests found increased pain, depressive symptoms, PTSD symptoms, and postconcussive symptoms; decreased performance on Trails B; increased FC between the thalamus and the default mode network; and decreased FC between the thalamus and the dorsal attention network and between the thalamus and the frontoparietal control network in patients with mTBI as compared with controls. The Spearman correlation coefficient indicated that increased FC between the thalamus and the dorsal attention network from baseline to 4 months was associated with decreased pain and postconcussive symptoms (corrected P<.05). Findings suggest that alterations in thalamic FC occur after mTBI, and improvements in pain and postconcussive symptoms are correlated with

  7. Impact of gastrointestinal events on patient-reported outcomes in Asia-Pacific women with osteoporosis: baseline results of the MUSIC OS-AP study.

    Science.gov (United States)

    Modi, A; Ebeling, P R; Lee, M S; Min, Y K; Mithal, A; Yang, X; Baidya, S; Sen, S; Sajjan, S

    2017-12-01

    The purpose of this study was to describe the impact of gastrointestinal events on patient-reported outcomes and health care resource use among Asia-Pacific women with postmenopausal osteoporosis. The results of this study show that gastrointestinal events decreased adherence, treatment satisfaction, and quality of life in Asia-Pacific women with postmenopausal osteoporosis. This study aimed to describe the impact of gastrointestinal (GI) events on patient-reported outcomes and health care resource use among Asia-Pacific women with postmenopausal osteoporosis. The MUSIC OS-AP study included an observational cohort study of postmenopausal women with osteoporosis. Women were classified as untreated or treated, with treated patients further classified as new or experienced users. Adherence was measured by the Adherence Evaluation of Osteoporosis treatment (ADEOS) questionnaire, treatment satisfaction by the Osteoporosis Patient Satisfaction Questionnaire (OPSAT) while general health-related and osteoporosis-specific quality of life were measured by the European Quality of Life-5 Dimensions (EQ-5D) questionnaire and the Osteoporosis Assessment Questionnaire (OPAQ), respectively. The association of GI events with these outcomes was determined by covariate-adjusted regression analysis of least squares mean differences in the scores of treated patients with and without GI events. Resource utilization was measured as the number of physician visits over the past 3 months, and multivariate regression analysis was used to assess the association of GI events with the likelihood of a visit. The GI event profile, quality of life scores, and resource use were numerically similar in untreated and treated women. The rate of adherence among treated women was higher in experienced than in new users. As indicated by mean scores, experienced users had better quality of life and slightly higher treatment satisfaction and fewer physician visits than new users. Except for adherence in

  8. 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.

  9. 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

  10. Quality of life: patient-reported outcomes after total replacement of the temporomandibular joint.

    Science.gov (United States)

    Kunjur, J; Niziol, R; Matthews, N S

    2016-09-01

    Since publication of the UK guidelines on total replacement of the temporomandibular joint (TMJ) in 2008 by the British Association of Oral and Maxillofacial Surgeons (BAOMS), pain scores, mouth opening, and diet have been used as markers of success. We have looked at quality of life (QoL) as another. We analysed the data from a single surgeon on patients who had had joints replaced and devised a questionnaire to find out about the subjective, functional, psychological, and social aspects of TMJ disease. A total of 18 patients who had the same operation were included (mean (range) age 50 (33 - 73) years, mean (range) follow up 30 (18 - 48) months). Jaw function and facial aesthetics had improved, and patients needed less analgesia. Overall, they reported a better QoL with improvements in mood and social interaction, and the activities of daily life were easier. The NHS uses QoL questionnaires to measure success in fields such as orthopaedic surgery, but currently we know of no nationally accepted questionnaire that measures success after total replacement of the TMJ. Copyright © 2016 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  11. 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

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

    Science.gov (United States)

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

    2018-05-01

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

  13. 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.

  14. The use of an iPad to collect patient-reported functional outcome measures in hand surgery.

    Science.gov (United States)

    Yaffe, Mark; Goyal, Nitin; Kokmeyer, Daniel; Merrell, Gregory A

    2015-09-01

    The purpose of this study was to evaluate (1) patient preferences regarding iPad and paper-based questionnaires, (2) the efficacy of iPad and paper questionnaires in a hand surgery practice, (3) the influence of questionnaire length on patient preferences and data collection, and (4) patient characteristics associated with a preference for iPad-based questionnaires. Two hundred total patients in a single hand surgery practice were randomly assigned to one of four groups. Each group completed either the Michigan Hand Questionnaire (MHQ) or QuickDASH (QD) using either an iPad or pen and paper. Patient preferences, questionnaire completion and timing, and demographic data were analyzed. The use of an iPad was associated with a statistically stronger preference for the same delivery format in the future compared to paper for the MHQ (93.9 vs 52.1 %, p iPad group found the survey "physically easy" more often compared to the MHQ paper group, while no difference was found among QD groups. Questionnaire timing between iPad and paper groups was similar for the MHQ but statistically longer with the iPad for QD. A significantly higher proportion of patients who preferred the iPad were under the age of 50 compared to those who preferred paper. The addition of an iPad is an efficient and preferable questionnaire format for functional outcome assessment in a hand and upper extremity surgery practice setting. The iPad is particularly preferable for longer outcome questionnaires and for patients under the age of 50.

  15. 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.

  16. Training hospital staff on spiritual care in palliative care influences patient-reported outcomes: Results of a quasi-experimental study.

    Science.gov (United States)

    van de Geer, Joep; Groot, Marieke; Andela, Richtsje; Leget, Carlo; Prins, Jelle; Vissers, Kris; Zock, Hetty

    2017-09-01

    Spiritual care is reported to be important to palliative patients. There is an increasing need for education in spiritual care. To measure the effects of a specific spiritual care training on patients' reports of their perceived care and treatment. A pragmatic controlled trial conducted between February 2014 and March 2015. The intervention was a specific spiritual care training implemented by healthcare chaplains to eight multidisciplinary teams in six hospitals on regular wards in which patients resided in both curative and palliative trajectories. In total, 85 patients were included based on the Dutch translation of the Supportive and Palliative Care Indicators Tool. Data were collected in the intervention and control wards pre- and post-training using questionnaires on physical symptoms, spiritual distress, involvement and attitudes (Spiritual Attitude and Involvement List) and on the perceived focus of healthcare professionals on patients' spiritual needs. All 85 patients had high scores on spiritual themes and involvement. Patients reported that attention to their spiritual needs was very important. We found a significant ( p = 0.008) effect on healthcare professionals' attention to patients' spiritual and existential needs and a significant ( p = 0.020) effect in favour of patients' sleep. No effect on the spiritual distress of patients or their proxies was found. The effects of spiritual care training can be measured using patient-reported outcomes and seemed to indicate a positive effect on the quality of care. Future research should focus on optimizing the spiritual care training to identify the most effective elements and developing strategies to ensure long-term positive effects. This study was registered at the Dutch Trial Register: NTR4559.

  17. 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.

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

    Science.gov (United States)

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

    2013-03-01

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

  19. 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...

  20. Correlation between pain response and improvements in patient-reported outcomes and health-related quality of life in duloxetine-treated patients with diabetic peripheral neuropathic pain

    Directory of Open Access Journals (Sweden)

    Ogawa K

    2015-08-01

    Full Text Available Kei Ogawa,1 Shinji Fujikoshi,2 William Montgomery,3 Levent Alev1 1Medical Science, 2Statistical Science, Eli Lilly Japan K.K., Kobe, Japan; 3Global Patient Outcomes and Real World Evidence, Eli Lilly Australia Pty Ltd, West Ryde, NSW, Australia Objective: We assessed whether quality of life (QoL improvement in duloxetine-treated patients with diabetic peripheral neuropathic pain (DPNP correlates with the extent of pain relief.Methods: Pooled data from three multicountry, double-blind, 12-week, placebo-controlled trials of duloxetine-treated (duloxetine 60 mg once daily; total number =335 patients with DPNP were analyzed. Based on improvement in 24-hour average pain scores, patients were stratified into four groups. Improvement in QoL, which was measured as the change from baseline in two patient-reported health outcome measures (Short Form [SF]-36 and five-dimension version of the EuroQol Questionnaire [EQ-5D], was evaluated and compared among the four groups. Pearson’s correlation coefficient was calculated to assess the correlation between improvement in pain scores and improvement in QoL.Results: The group with more pain improvement generally showed greater mean change from baseline in all of the SF-36 scale scores and on the EQ-5D index. Pearson’s correlation coefficients ranged from 0.114 to 0.401 for the SF-36 scale scores (P<0.05, and it was 0.271 for the EQ-5D (P<0.001.Conclusion: Improvement in pain scores was positively correlated with improvement in QoL and patient-reported outcomes in duloxetine-treated patients. Keywords: diabetic peripheral neuropathic pain, duloxetine, efficacy, function, quality of life

  1. 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.

  2. 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.

  3. 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...

  4. 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

  5. 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.

  6. How bad is bile acid diarrhoea: an online survey of patient-reported symptoms and outcomes.

    Science.gov (United States)

    Bannaga, Ayman; Kelman, Lawrence; O'Connor, Michelle; Pitchford, Claire; Walters, Julian R F; Arasaradnam, Ramesh P

    2017-01-01

    Bile acid diarrhoea (BAD) is an underdiagnosed condition producing diarrhoea, urgency and fear of faecal incontinence. How patients experience these symptoms has not previously been studied. Bile Acid Malabsorption (BAM) Support UK was established in 2015 as a national charity with objectives including to provide details regarding how BAD affects patients, to improve earlier recognition and clinical management. A questionnaire was collected anonymously by BAM Support UK and the Bile Salt Malabsorption Facebook group over 4 weeks at the end of 2015. It comprised 56 questions and aimed to inform patients and clinicians about how BAD affects the respondents. The first 100 responses were analysed. 91% of the respondents reported a diagnosis of BAD. 58% of total respondents diagnosed following a Selenium-homocholic acid taurine scan, 69% were diagnosed by a gastroenterologist, with type 2 and 3 BAD comprising 38% and 37%, respectively, of total respondents. Symptoms had been experienced for more than 5 years before diagnosis in 44% of respondents. Following treatment, usually with bile acid sequestrants, 60% of participants reported improvement of diarrhoea and most reported their mental health has been positively impacted. Just over half of the cohort felt as though their symptoms had been dismissed during clinical consultations and 28% felt their GPs were unaware of BAD. BAD requires more recognition by clinicians to address the current delays in diagnosis. Treatment improves physical and mental symptoms in the majority of participants.

  7. 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.

  8. 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....

  9. Initial report of the cancer Patient-Reported Outcomes Measurement Information System (PROMIS) sexual function committee: review of sexual function measures and domains used in oncology.

    Science.gov (United States)

    Jeffery, Diana D; Tzeng, Janice P; Keefe, Francis J; Porter, Laura S; Hahn, Elizabeth A; Flynn, Kathryn E; Reeve, Bryce B; Weinfurt, Kevin P

    2009-03-15

    For this report, the authors described the initial activities of the Cancer Patient-Reported Outcomes Measurement Information System (PROMIS)-Sexual Function domain group, which is part of the National Institutes of Health Roadmap Initiative to develop brief questionnaires or individually tailored assessments of quality-of-life domains. Presented are a literature review of sexual function measures used in cancer populations and descriptions of the domains found in those measures. By using a consensus-driven approach, an electronic bibliographic search was conducted for articles that were published from 1991 to 2007, and 486 articles were identified for in-depth review. In total, 257 articles reported the administration of a psychometrically evaluated sexual function measure to individuals who were diagnosed with cancer. Apart from the University of California-Los Angeles Prostate Cancer Index, the International Index of Erectile Function, and the Female Sexual Function Index, the 31 identified measures have not been tested widely in cancer populations. Most measures were multidimensional and included domains related to the sexual response cycle and to general sexual satisfaction. The current review supports the need for a flexible, psychometrically robust measure of sexual function for use in oncology settings and strongly justifies the development of the PROMIS-Sexual Function instrument. When the PROMIS-Sexual Function instrument is available publicly, cancer clinicians and researchers will have another measure with which to assess patient-reported sexual function outcomes in addition to the few legacy measures that were identified through this review. Copyright (c) 2009 American Cancer Society.

  10. Using classical test theory, item response theory, and Rasch measurement theory to evaluate patient-reported outcome measures: a comparison of worked examples.

    Science.gov (United States)

    Petrillo, Jennifer; Cano, Stefan J; McLeod, Lori D; Coon, Cheryl D

    2015-01-01

    To provide comparisons and a worked example of item- and scale-level evaluations based on three psychometric methods used in patient-reported outcome development-classical test theory (CTT), item response theory (IRT), and Rasch measurement theory (RMT)-in an analysis of the National Eye Institute Visual Functioning Questionnaire (VFQ-25). Baseline VFQ-25 data from 240 participants with diabetic macular edema from a randomized, double-masked, multicenter clinical trial were used to evaluate the VFQ at the total score level. CTT, RMT, and IRT evaluations were conducted, and results were assessed in a head-to-head comparison. Results were similar across the three methods, with IRT and RMT providing more detailed diagnostic information on how to improve the scale. CTT led to the identification of two problematic items that threaten the validity of the overall scale score, sets of redundant items, and skewed response categories. IRT and RMT additionally identified poor fit for one item, many locally dependent items, poor targeting, and disordering of over half the response categories. Selection of a psychometric approach depends on many factors. Researchers should justify their evaluation method and consider the intended audience. If the instrument is being developed for descriptive purposes and on a restricted budget, a cursory examination of the CTT-based psychometric properties may be all that is possible. In a high-stakes situation, such as the development of a patient-reported outcome instrument for consideration in pharmaceutical labeling, however, a thorough psychometric evaluation including IRT or RMT should be considered, with final item-level decisions made on the basis of both quantitative and qualitative results. Copyright © 2015. Published by Elsevier Inc.

  11. Tofacitinib in Combination With Conventional Disease-Modifying Antirheumatic Drugs in Patients With Active Rheumatoid Arthritis: Patient-Reported Outcomes From a Phase III Randomized Controlled Trial.

    Science.gov (United States)

    Strand, Vibeke; Kremer, Joel M; Gruben, David; Krishnaswami, Sriram; Zwillich, Samuel H; Wallenstein, Gene V

    2017-04-01

    Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We compared patient-reported outcomes (PROs) in patients with RA treated with tofacitinib or placebo in combination with conventional disease-modifying antirheumatic drugs (DMARDs). In a 12-month, phase III randomized controlled trial (ORAL Sync), patients (n = 795) with active RA and previous inadequate response to therapy with ≥1 conventional or biologic DMARD were randomized 4:4:1:1 to tofacitinib 5 mg twice daily (BID), tofacitinib 10 mg BID, placebo advanced to 5 mg BID, or placebo to 10 mg BID, in combination with stable background DMARD therapy. PROs included patient global assessment of arthritis (PtGA), patient assessment of arthritis pain (Pain), physical function (Health Assessment Questionnaire disability index [HAQ DI]), health-related quality of life (Short Form 36 health survey [SF-36]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F]), and sleep (Medical Outcomes Study Sleep [MOS Sleep]). At month 3, statistically significant improvements from baseline versus placebo were reported in PtGA, Pain, HAQ DI, all 8 SF-36 domains, FACIT-F, and MOS Sleep with tofacitinib 10 mg BID, and in PtGA, Pain, HAQ DI, 7 SF-36 domains, FACIT-F, and MOS Sleep with tofacitinib 5 mg BID. Improvements were sustained to month 12. Significantly more tofacitinib-treated patients reported improvements of greater than or equal to the minimum clinically important differences at month 3 versus placebo in all PROs, except the SF-36 role-emotional domain (significant for tofacitinib 10 mg BID). Patients with active RA treated with tofacitinib combined with background conventional DMARD therapy reported sustained, significant, and clinically meaningful improvements in PROs versus placebo. © 2016, The Authors. Arthritis Care & Research published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology.

  12. Development of Patient-reported Outcomes Measure of Pharmaceutical Therapy for Quality of Life (PROMPT-QoL): A novel instrument for medication management.

    Science.gov (United States)

    Sakthong, Phantipa; Suksanga, Phattrapa; Sakulbumrungsil, Rungpetch; Winit-Watjana, Win

    2015-01-01

    Medicines can affect a patient's health-related quality of life (HRQoL), but there exists no standardized HRQoL measure for medication management. To develop the new HRQoL instrument "Patient-reported Outcomes Measure of Pharmaceutical Therapy for Quality of Life" (PROMPT-QoL), and to evaluate its content validity and preliminary psychometrics using a Rasch model. The PROMPT-QoL questionnaire was developed through the concept review, item generation, cognitive interviews, and initial psychometric evaluation. Its first draft was initially tested by Round-1 interviews of 120 adult outpatients taking their medicines at least three months continuously. The final draft with 43 items was then constructed and checked by 10 physicians and 5 pharmacists for the questionnaire importance and content validity. Round-2 interviews in six patient groups with 10 patients of each were conducted to elicit patients' understanding of the questionnaire and assess preliminary psychometrics using the Rasch analysis, including fit statistics, person and item reliabilities. The 43-item PROMPT-QoL comprised 10 domains: General Attitude toward Medication Use, Medicine Information, Disease Information, Medicine Effectiveness, Impacts of Medicines and Side-effects, Psychological Impacts of Medication Use, Convenience, Availability and Accessibility, Therapeutic Relationship with Healthcare Providers, and Overall QoL. Based on the patient interviews and expert review, the questionnaire was considered important, useful, and comprehensive. All items and domains yielded content validity indexes above the acceptable values of 0.80 and 0.90, respectively. In Round 2, thirty-nine problems identified in Group 1 were reduced to two issues in Group 6 after amendments. The Rasch analysis revealed eight items were misfit and two domains were reliable for both personal and item aspects (Medicine Information and Psychological Impacts of Medication Use). The newly developed PROMPT-QoL has favorable content

  13. Validity of patient-reported swallowing and speech outcomes in relation to objectively measured oral function among patients treated for oral or oropharyngeal cancer.

    Science.gov (United States)

    Rinkel, R N P M; Verdonck-de Leeuw, I M; de Bree, R; Aaronson, N K; Leemans, C R

    2015-04-01

    The objective of this study was to test the construct validity of the patient-reported outcomes Swallowing Quality of Life Questionnaire (SWAL-QOL) and Speech Handicap Index (SHI) in relation to objectively measured oral function among patients treated for oral or oropharyngeal cancer. The study sample consisted of patients treated for oral or oropharyngeal cancer. Outcome measures were the SWAL-QOL and the SHI, and the Functional Rehabilitation Outcomes Grade (FROG), a test to measure oral and shoulder function. Spearman's rank correlation coefficient was used to test associations between the SHI and SWAL-QOL scales, and the FROG scales. During a study period of 3 months, 38 patients (21 males, 17 females; mean age 54 years) were included who visited the outpatient clinic for follow-up care 6-155 months after surgical treatment (n = 14) or combined surgery and radiotherapy (n = 24) for oral (n = 21) or oropharyngeal cancer (n = 17). Most SWAL-QOL and SHI scales (except the SWAL-QOL Fatigue scale) correlated significantly with one or more FROG oral function scales. None of the SWAL-QOL and SHI scales correlated significantly with the FROG shoulder function scale. These results support the construct validity of the SWAL-QOL and SHI questionnaires for assessing speech and swallowing problems in daily life that are moderately but significantly related to oral function. A multidimensional assessment protocol is recommended for use in clinical practice and for research purposes for measuring oral function and swallowing- and speech-related problems in daily life among head and neck cancer patients.

  14. Cognitive interviewing methodology in the development of a pediatric item bank: a patient reported outcomes measurement information system (PROMIS study

    Directory of Open Access Journals (Sweden)

    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.

  15. Qualitative approach to patient-reported outcomes in oncology: protocol of a French study.

    Science.gov (United States)

    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

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

    Science.gov (United States)

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

    2013-07-30

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

  17. PROMIS GH (Patient-Reported Outcomes Measurement Information System Global Health) Scale in Stroke: A Validation Study.

    Science.gov (United States)

    Katzan, Irene L; Lapin, Brittany

    2018-01-01

    The International Consortium for Health Outcomes Measurement recently included the 10-item PROMIS GH (Patient-Reported Outcomes Measurement Information System Global Health) scale as part of their recommended Standard Set of Stroke Outcome Measures. Before collection of PROMIS GH is broadly implemented, it is necessary to assess its performance in the stroke population. The objective of this study was to evaluate the psychometric properties of PROMIS GH in patients with ischemic stroke and intracerebral hemorrhage. PROMIS GH and 6 PROMIS domain scales measuring same/similar constructs were electronically collected on 1102 patients with ischemic and hemorrhagic strokes at various stages of recovery from their stroke who were seen in a cerebrovascular clinic from October 12, 2015, through June 2, 2017. Confirmatory factor analysis was performed to evaluate the adequacy of 2-factor structure of component scores. Test-retest reliability and convergent validity of PROMIS GH items and component scores were assessed. Discriminant validity and responsiveness were compared between PROMIS GH and PROMIS domain scales measuring the same or related constructs. Analyses were repeated stratified by stroke subtype and modified Rankin Scale score validity was good with significant correlations between all PROMIS GH items and PROMIS domain scales ( P 0.5) was demonstrated for 8 of the 10 PROMIS GH items. Reliability and validity remained consistent across stroke subtype and disability level (modified Rankin Scale, <2 versus ≥2). PROMIS GH exhibits acceptable performance in patients with stroke. Our findings support International Consortium for Health Outcomes Measurement recommendation to use PROMIS GH as part of the standard set of outcome measures in stroke. © 2017 American Heart Association, Inc.

  18. 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

  19. 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.

  20. Observational study to characterise 24-hour COPD symptoms and their relationship with patient-reported outcomes: results from the ASSESS study.

    Science.gov (United States)

    Miravitlles, Marc; Worth, Heinrich; Soler Cataluña, Juan José; Price, David; De Benedetto, Fernando; Roche, Nicolas; Godtfredsen, Nina Skavlan; van der Molen, Thys; Löfdahl, Claes-Göran; Padullés, Laura; Ribera, Anna

    2014-10-21

    Few studies have investigated the 24-hour symptom profile in patients with COPD or how symptoms during the 24-hour day are inter-related. This observational study assessed the prevalence, severity and relationship between night-time, early morning and daytime COPD symptoms and explored the relationship between 24-hour symptoms and other patient-reported outcomes. The study enrolled patients with stable COPD in clinical practice. Baseline night-time, early morning and daytime symptoms (symptom questionnaire), severity of airflow obstruction (FEV1), dyspnoea (modified Medical Research Council Dyspnoea Scale), health status (COPD Assessment Test), anxiety and depression levels (Hospital Anxiety and Depression Scale), sleep quality (COPD and Asthma Sleep Impact Scale) and physical activity level (sedentary, moderately active or active) were recorded. The full analysis set included 727 patients: 65.8% male, mean ± standard deviation age 67.2 ± 8.8 years, % predicted FEV1 52.8 ± 20.5%. In each part of the 24-hour day, >60% of patients reported experiencing ≥1 symptom in the week before baseline. Symptoms were more common in the early morning and daytime versus night-time (81.4%, 82.7% and 63.0%, respectively). Symptom severity was comparable for each period assessed. Overall, in the week before baseline, 56.7% of patients had symptoms throughout the whole 24-hour day (3 parts of the day); 79.9% had symptoms in ≥2 parts of the 24-hour day. Symptoms during each part of the day were inter-related, irrespective of disease severity (all p < 0.001). Early morning and daytime symptoms were associated with the severity of airflow obstruction (p < 0.05 for both). Night-time, early morning and daytime symptoms were all associated with worse dyspnoea, health status and sleep quality, and higher anxiety and depression levels (all p < 0.001 versus patients without symptoms in each corresponding period). In each part of the 24-hour day, there was also an association between

  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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

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

    Science.gov (United States)

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

    2018-03-01

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

  8. 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.

  9. 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

  10. The colostomy impact score: development and validation of a patient reported outcome measure for rectal cancer patients with a permanent colostomy. A population-based study.

    Science.gov (United States)

    Thyø, A; Emmertsen, K J; Pinkney, T D; Christensen, P; Laurberg, S

    2017-01-01

    The aim was to develop and validate a simple scoring system evaluating the impact of colostomy dysfunction on quality of life (QOL) in patients with a permanent stoma after rectal cancer treatment. In this population-based study, 610 patients with a permanent colostomy after previous rectal cancer treatment during the period 2001-2007 completed two questionnaires: (i) the basic stoma questionnaire consisting of 22 items about stoma function with one anchor question addressing the overall stoma impact on QOL and (ii) the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30. Answers from half of the cohort were used to develop the score and subsequently validated on the remaining half. Logistic regression analyses identified and selected items for the score and multivariate analysis established the score value allocated to each item. The colostomy impact score includes seven items with a total range from 0 to 38 points. A score of ≥ 10 indicates major colostomy impact (Major CI). The score has a sensitivity of 85.7% for detecting patients with significant stoma impact on QOL. Using the EORTC QLQ scales, patients with Major CI experienced significant impairment in their QOL compared to the Minor CI group. This new scoring system appears valid for the assessment of the impact on QOL from having a permanent colostomy in a Danish rectal cancer population. It requires validation in non-Danish populations prior to its acceptance as a valuable patient-reported outcome measure for patients internationally. Colorectal Disease © 2016 The Association of Coloproctology of Great Britain and Ireland.

  11. Introducing the Concept of the Minimally Important Difference to Determine a Clinically Relevant Change on Patient-Reported Outcome Measures in Patients with Intermittent Claudication

    International Nuclear Information System (INIS)

    Conijn, Anne P.; Jonkers, Wilma; Rouwet, Ellen V.; Vahl, Anco C.; Reekers, Jim A.; Koelemay, Mark J. W.

    2015-01-01

    PurposeThe minimally important difference (MID) represents the smallest change in score on patient-reported outcome measures that is relevant to patients. The aim of this study was to introduce the MID for the Vascular Quality of Life Questionnaire (VascuQol) and the walking impairment questionnaire (WIQ) for patients with intermittent claudication (IC).MethodsIn this multicenter study, we recruited 294 patients with IC between July and October 2012. Patients completed the VascuQol, with scores ranging from 1 to 7 (worst to best), and the WIQ, with scores ranging from 0 to 1 (worst to best) at first visit and after 4 months follow-up. In addition, patients answered an anchor-question rating their health status compared to baseline, as being improved, unchanged, or deteriorated. The MID for improvement and deterioration was calculated by an anchor-based approach, and determined with the upper and lower limits of the 95 % confidence interval of the mean change of the group who had not changed according to the anchor-question.ResultsFor the MID analyses of the VascuQol and WIQ, 163 and 134 patients were included, respectively. The MID values for the VascuQol (mean baseline score 4.25) were 0.87 for improvement and 0.23 for deterioration. For the WIQ (mean baseline score 0.39), we found MID values of 0.11 and −0.03 for improvement and deterioration, respectively.ConclusionIn this study, we calculated the MID for the VascuQol and the WIQ. Applying these MID facilitates better interpretation of treatment outcomes and can help to set treatment goals for individual care

  12. Self-Reported Health Experiences of Children Living with Congenital Heart Defects: Including Patient-Reported Outcomes in a National Cohort Study.

    Science.gov (United States)

    Knowles, Rachel Louise; Tadic, Valerija; Hogan, Ailbhe; Bull, Catherine; Rahi, Jugnoo Sangeeta; Dezateux, Carol

    2016-01-01

    and evaluating clinical practice and service provision through seeking patient-reported outcomes in paediatric care.

  13. Introducing the Concept of the Minimally Important Difference to Determine a Clinically Relevant Change on Patient-Reported Outcome Measures in Patients with Intermittent Claudication

    Energy Technology Data Exchange (ETDEWEB)

    Conijn, Anne P., E-mail: a.p.conijn@amc.nl [Academic Medical Center, Departments of Vascular Surgery and Interventional Radiology (Netherlands); Jonkers, Wilma, E-mail: wilma.jonkers@achmea.nl [Achmea Insurances, Division of Health Care (Netherlands); Rouwet, Ellen V., E-mail: e.rouwet@erasmusmc.nl [Erasmus Medical Center, Department of Vascular Surgery (Netherlands); Vahl, Anco C., E-mail: a.c.vahl@olvg.nl [Onze Lieve Vrouwe Gasthuis, Department of Vascular Surgery (Netherlands); Reekers, Jim A., E-mail: j.a.reekers@amc.nl [Academic Medical Center, Department of Radiology (Netherlands); Koelemay, Mark J. W., E-mail: m.j.koelemaij@amc.nl [Academic Medical Center, Department of vascular surgery (Netherlands)

    2015-10-15

    PurposeThe minimally important difference (MID) represents the smallest change in score on patient-reported outcome measures that is relevant to patients. The aim of this study was to introduce the MID for the Vascular Quality of Life Questionnaire (VascuQol) and the walking impairment questionnaire (WIQ) for patients with intermittent claudication (IC).MethodsIn this multicenter study, we recruited 294 patients with IC between July and October 2012. Patients completed the VascuQol, with scores ranging from 1 to 7 (worst to best), and the WIQ, with scores ranging from 0 to 1 (worst to best) at first visit and after 4 months follow-up. In addition, patients answered an anchor-question rating their health status compared to baseline, as being improved, unchanged, or deteriorated. The MID for improvement and deterioration was calculated by an anchor-based approach, and determined with the upper and lower limits of the 95 % confidence interval of the mean change of the group who had not changed according to the anchor-question.ResultsFor the MID analyses of the VascuQol and WIQ, 163 and 134 patients were included, respectively. The MID values for the VascuQol (mean baseline score 4.25) were 0.87 for improvement and 0.23 for deterioration. For the WIQ (mean baseline score 0.39), we found MID values of 0.11 and −0.03 for improvement and deterioration, respectively.ConclusionIn this study, we calculated the MID for the VascuQol and the WIQ. Applying these MID facilitates better interpretation of treatment outcomes and can help to set treatment goals for individual care.

  14. 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

  15. 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

  16. 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

  17. 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...

  18. Correlations between FEV1 and patient-reported outcomes: A pooled analysis of 23 clinical trials in patients with chronic obstructive pulmonary disease.

    Science.gov (United States)

    Donohue, James F; Jones, Paul W; Bartels, Christian; Marvel, Jessica; D'Andrea, Peter; Banerji, Donald; Morris, David G; Patalano, Francesco; Fogel, Robert

    2018-04-01

    In clinical trials of inhaled bronchodilators, chronic obstructive pulmonary disease (COPD) guidelines recommend that patient-reported outcomes (PROs) are assessed alongside lung function. How these endpoints are related is unclear. Pooled longitudinal data from 23 randomised controlled COPD studies were analyzed (N = 23,213). Treatments included long-acting β 2 agonists, long-acting muscarinic antagonists (LABAs or LAMAs) and the LABA/LAMA combination QVA149. Outcome measures were Transition Dyspnoea Index (TDI) and St. George's Respiratory Questionnaire (SGRQ) scores, COPD exacerbation frequency and rescue medication use. Relationships between changes in trough forced expiratory volume in one second (ΔFEV 1 ) and outcomes following treatment were assessed using correlations of data summaries and model-based analysis: generalized linear mixed-effect regression modelling to determine if ΔFEV 1 could predict patient outcomes with different treatments. Mean age was 64 years, 73% were male, and most had moderate (45%) or severe (52%) disease. Statistically significant correlations were observed between ΔFEV 1 and each outcome measure (exacerbations Rs = 0.05; rescue medication, SGRQ, TDI, r = 0.11-0.16; all p < .001). Patients with greater improvements in trough FEV 1 had on average better SGRQ and TDI scores, fewer exacerbations, and used less rescue medication. For SGRQ and TDI scores, minimal clinically important differences were observed over the range of pooled ΔFEV 1 values. Model-based predictions confirmed the treatment effect was partly explained by changes in FEV 1 from baseline with improvements in PROs observed across all treatments when trough FEV 1 improved. Across all endpoints active treatments were better than placebo (p < .0001), and LABA/LAMA treatment resulted in numerically better treatment outcomes than either monocomponent. These data suggest that FEV 1 improvements post-bronchodilation correlate with PRO improvements

  19. Differences in characteristics and patient-reported questionnaire responses in patients who choose non-surgical versus surgical treatment for severe hip osteoarthritis

    DEFF Research Database (Denmark)

    Have, Mads; Overgaard, Søren; Jensen, Carsten

    Background: Preoperative patient characteristics may influence patient choice for participating in RCT’s. Purpose / Aim of Study: This study aimed to compare patient characteristics, level of pain, physical function and joint space width in patients with severe hip osteoarthritis (OA) who accepted...... or refused to participate in a RCT. Materials and Methods: In this prospective cohort study a total of 137 patients with primary hip OA were asked to choose between surgical or non- surgical treatment. We then compared the characteristics of each patient cohort (demographics, pain level and duration......, analgesic use, exercise habits), the radiographic hip OA state and their responses to Hip dysfunction and Osteoarthritis Outcome Score (HOOS, 0-100) and European Quality of Life Scale (EQ-5D-5L) questionnaires. Findings / Results: The between-group HOOS scores were significantly different in three out...

  20. Advantages and psychometric validation of proximal intensive assessments of patient-reported outcomes collected in daily life.

    Science.gov (United States)

    Carlson, Eve B; Field, Nigel P; Ruzek, Josef I; Bryant, Richard A; Dalenberg, Constance J; Keane, Terrence M; Spain, David A

    2016-03-01

    Ambulatory assessment data collection methods are increasingly used to study behavior, experiences, and patient-reported outcomes (PROs), such as emotions, cognitions, and symptoms in clinical samples. Data collected close in time at frequent and fixed intervals can assess PROs that are discrete or changing rapidly and provide information about temporal dynamics or mechanisms of change in clinical samples and individuals, but clinical researchers have not yet routinely and systematically investigated the reliability and validity of such measures or their potential added value over conventional measures. The present study provides a comprehensive, systematic evaluation of the psychometrics of several proximal intensive assessment (PIA) measures in a clinical sample and investigates whether PIA appears to assess meaningful differences in phenomena over time. Data were collected on a variety of psychopathology constructs on handheld devices every 4 h for 7 days from 62 adults recently exposed to traumatic injury of themselves or a family member. Data were also collected on standard self-report measures of the same constructs at the time of enrollment, 1 week after enrollment, and 2 months after injury. For all measure scores, results showed good internal consistency across items and within persons over time, provided evidence of convergent, divergent, and construct validity, and showed significant between- and within-subject variability. Results indicate that PIA measures can provide valid measurement of psychopathology in a clinical sample. PIA may be useful to study mechanisms of change in clinical contexts, identify targets for change, and gauge treatment progress.

  1. PATIENT-REPORTED OUTCOMES IN RARE LYSOSOMAL STORAGE DISEASES: KEY INFORMANT INTERVIEWS AND A SYSTEMATIC REVIEW PROTOCOL.

    Science.gov (United States)

    Miller, Patricia A; Mulla, Sohail M; Adams-Webber, Thomasin; Sivji, Yasmin; Guyatt, Gordon H; Johnston, Bradley C

    2016-01-01

    To investigate the use, challenges and opportunities associated with using patient-reported outcomes (PROs) in studies with patients with rare lysosomal storage diseases (LSDs), we conducted interviews with researchers and health technology assessment (HTA) experts, and developed the methods for a systematic review of the literature. The purpose of the review is to identify the psychometrically sound generic and disease-specific PROs used in studies with patients with five LSDs of interest: Fabry, Gaucher (Type I), Niemann-Pick (Type B) and Pompe diseases, and mucopolysaccharidosis (Types I and II). Researchers and HTA experts who responded to an email invitation participated in a telephone interview. We used qualitative content analysis to analyze the anonymized transcripts. We conducted a comprehensive literature search for studies that used PROs to investigate burden of disease or to assess the impact of interventions across the five LSDs of interest. Interviews with seven researchers and six HTA experts representing eight countries revealed five themes. These were: (i) the importance of using psychometrically sound PROs in studies with rare diseases, (ii) the paucity of disease-specific PROs, (iii) the importance of having PRO data for economic analyses, (iv) practical and psychometric limitations of existing PROs, and (v) suggestions for new PROs. The systematic review has been completed. The interviews highlight current challenges and opportunities experienced by researchers and HTA experts involved in work with rare LSDs. The ongoing systematic review will highlight the experience, opportunities, and limitations of PROs in LSDs and provide suggestions for future research.

  2. What are the appropriate methods for analyzing patient-reported outcomes in randomized trials when data are missing?

    Science.gov (United States)

    Hamel, J F; Sebille, V; Le Neel, T; Kubis, G; Boyer, F C; Hardouin, J B

    2017-12-01

    Subjective health measurements using Patient Reported Outcomes (PRO) are increasingly used in randomized trials, particularly for patient groups comparisons. Two main types of analytical strategies can be used for such data: Classical Test Theory (CTT) and Item Response Theory models (IRT). These two strategies display very similar characteristics when data are complete, but in the common case when data are missing, whether IRT or CTT would be the most appropriate remains unknown and was investigated using simulations. We simulated PRO data such as quality of life data. Missing responses to items were simulated as being completely random, depending on an observable covariate or on an unobserved latent trait. The considered CTT-based methods allowed comparing scores using complete-case analysis, personal mean imputations or multiple-imputations based on a two-way procedure. The IRT-based method was the Wald test on a Rasch model including a group covariate. The IRT-based method and the multiple-imputations-based method for CTT displayed the highest observed power and were the only unbiased method whatever the kind of missing data. Online software and Stata® modules compatibles with the innate mi impute suite are provided for performing such analyses. Traditional procedures (listwise deletion and personal mean imputations) should be avoided, due to inevitable problems of biases and lack of power.

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

    Science.gov (United States)

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

    2018-05-17

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

  4. [Reliability and validity of the Chinese version on Comprehensive Scores for Financial Toxicity based on the patient-reported outcome measures].

    Science.gov (United States)

    Yu, H H; Bi, X; Liu, Y Y

    2017-08-10

    Objective: To evaluate the reliability and validity of the Chinese version on comprehensive scores for financial toxicity (COST), based on the patient-reported outcome measures. Methods: A total of 118 cancer patients were face-to-face interviewed by well-trained investigators. Cronbach's α and Pearson correlation coefficient were used to evaluate reliability. Content validity index (CVI) and exploratory factor analysis (EFA) were used to evaluate the content validity and construct validity, respectively. Results: The Cronbach's α coefficient appeared as 0.889 for the whole questionnaire, with the results of test-retest were between 0.77 and 0.98. Scale-content validity index (S-CVI) appeared as 0.82, with item-content validity index (I-CVI) between 0.83 and 1.00. Two components were extracted from the Exploratory factor analysis, with cumulative rate as 68.04% and loading>0.60 on every item. Conclusion: The Chinese version of COST scale showed high reliability and good validity, thus can be applied to assess the financial situation in cancer patients.

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

    Science.gov (United States)

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

    2018-03-01

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

  6. Using R and WinBUGS to fit a generalized partial credit model for developing and evaluating patient-reported outcomes assessments.

    Science.gov (United States)

    Li, Yuelin; Baser, Ray

    2012-08-15

    The US Food and Drug Administration recently announced the final guidelines on the development and validation of patient-reported outcomes (PROs) assessments in drug labeling and clinical trials. This guidance paper may boost the demand for new PRO survey questionnaires. Henceforth, biostatisticians may encounter psychometric methods more frequently, particularly item response theory (IRT) models to guide the shortening of a PRO assessment instrument. This article aims to provide an introduction on the theory and practical analytic skills in fitting a generalized partial credit model (GPCM) in IRT. GPCM theory is explained first, with special attention to a clearer exposition of the formal mathematics than what is typically available in the psychometric literature. Then, a worked example is presented, using self-reported responses taken from the international personality item pool. The worked example contains step-by-step guides on using the statistical languages r and WinBUGS in fitting the GPCM. Finally, the Fisher information function of the GPCM model is derived and used to evaluate, as an illustrative example, the usefulness of assessment items by their information contents. This article aims to encourage biostatisticians to apply IRT models in the re-analysis of existing data and in future research. Copyright © 2012 John Wiley & Sons, Ltd.

  7. Comparing oncoplastic breast conserving surgery with mastectomy and immediate breast reconstruction: Case-matched patient reported outcomes.

    Science.gov (United States)

    Kelsall, Jennett E; McCulley, Stephen J; Brock, Lisa; Akerlund, Malin T E; Macmillan, R Douglas

    2017-10-01

    Oncoplastic breast conserving surgery (OBCS) allows women who may otherwise have mastectomy and immediate reconstruction (MxIR) the choice to conserve their breast yet avoid deformity. We compared the outcome of these options. Two cohorts meeting study criteria were identified from prospectively audited series of women undergoing OBCS or MxIR. After case matching for age, tumour size and date of surgery, stratification by breast size and controlling for radiotherapy; body image scale (BIS) scores of psychosocial function and patient reported outcome measures (PROMs) for breast appearance and return to function were analysed. A total of 567 women (286 treated by OBCS and 281 by MxIR) fulfilled inclusion criteria. Demographics were similar between the two unmatched cohorts, except for radiotherapy, age and tumour size (all p < 0.001). Overall, BIS score (p = 0.002), self-rated breast appearance, return to work and function (all p < 0.001) significantly favoured OBCS. Case-matched women with larger breasts treated by OBCS reported better BIS scores (mean 3.30 vs. 5.37, p = 0.011) and self-rated breast appearance score (p < 0.001) than MxIR, whereas no significant difference was observed for smaller breasts. BIS and appearance favoured OBCS, regardless of whether radiotherapy would have been avoided if treated by MxIR. OBCS offers suitable women the option to avoid MxIR while providing faster recovery. Better psychosocial and self-rated satisfaction with breast appearance is achieved for OBCS in all groups, regardless of the need for radiotherapy, apart from those women with smaller breasts for whom the results are comparable. Copyright © 2017 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

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

    Science.gov (United States)

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

    2015-06-01

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

  9. Phelan-McDermid syndrome data network: Integrating patient reported outcomes with clinical notes and curated genetic reports.

    Science.gov (United States)

    Kothari, Cartik; Wack, Maxime; Hassen-Khodja, Claire; Finan, Sean; Savova, Guergana; O'Boyle, Megan; Bliss, Geraldine; Cornell, Andria; Horn, Elizabeth J; Davis, Rebecca; Jacobs, Jacquelyn; Kohane, Isaac; Avillach, Paul

    2017-09-01

    The heterogeneity of patient phenotype data are an impediment to the research into the origins and progression of neuropsychiatric disorders. This difficulty is compounded in the case of rare disorders such as Phelan-McDermid Syndrome (PMS) by the paucity of patient clinical data. PMS is a rare syndromic genetic cause of autism and intellectual deficiency. In this paper, we describe the Phelan-McDermid Syndrome Data Network (PMS_DN), a platform that facilitates research into phenotype-genotype correlation and progression of PMS by: a) integrating knowledge of patient phenotypes extracted from Patient Reported Outcomes (PRO) data and clinical notes-two heterogeneous, underutilized sources of knowledge about patient phenotypes-with curated genetic information from the same patient cohort and b) making this integrated knowledge, along with a suite of statistical tools, available free of charge to authorized investigators on a Web portal https://pmsdn.hms.harvard.edu. PMS_DN is a Patient Centric Outcomes Research Initiative (PCORI) where patients and their families are involved in all aspects of the management of patient data in driving research into PMS. To foster collaborative research, PMS_DN also makes patient aggregates from this knowledge available to authorized investigators using distributed research networks such as the PCORnet PopMedNet. PMS_DN is hosted on a scalable cloud based environment and complies with all patient data privacy regulations. As of October 31, 2016, PMS_DN integrates high-quality knowledge extracted from the clinical notes of 112 patients and curated genetic reports of 176 patients with preprocessed PRO data from 415 patients. © 2017 The Authors. American Journal of Medical Genetics Part B: Neuropsychiatric Genetics Published by Wiley Periodicals, Inc.

  10. Hybrid surgery-radiosurgery therapy for metastatic epidural spinal cord compression: A prospective evaluation using patient-reported outcomes.

    Science.gov (United States)

    Barzilai, Ori; Amato, Mary-Kate; McLaughlin, Lily; Reiner, Anne S; Ogilvie, Shahiba Q; Lis, Eric; Yamada, Yoshiya; Bilsky, Mark H; Laufer, Ilya

    2018-05-01

    Patient-reported outcomes (PRO) represent an important measure of cancer therapy effect. For patients with metastatic epidural spinal cord compression (MESCC), hybrid therapy using separation surgery and stereotactic radiosurgery preserves neurologic function and provides tumor control. There is currently a paucity of data reporting PRO after such combined modality therapy for MESCC. Delineation of hybrid surgery-radiosurgery therapy effect on PRO validates the hybrid approach as an effective therapy resulting in meaningful symptom relief. Brief Pain Inventory (BPI) and MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP), PROs validated in the cancer population, were prospectively collected. Patients with MESCC who underwent separation surgery followed by stereotactic radiosurgery were included. Separation surgery included a posterolateral approach without extensive cytoreductive tumor excision. A median postoperative radiosurgery dose of 2700 cGy was delivered. The change in PRO 3 months after the hybrid therapy represented the primary study outcome. Preoperative and postoperative evaluations were analyzed using the Wilcoxon signed-rank test for matched pairs. One hundred eleven patients were included. Hybrid therapy resulted in a significant reduction in the BPI items "worst" and "right now" pain ( P < .0001), and in all BPI constructs (severity, interference with daily activities, and pain experience, P < .001). The MDASI-SP demonstrated reduction in spine-specific pain severity and interference with general activity ( P < .001), along with decreased symptom interference ( P < .001). Validated PRO instruments showed that in patients with MESCC, hybrid therapy with separation surgery and radiosurgery results in a significant decrease in pain severity and symptom interference. These prospective data confirm the benefit of hybrid therapy for treatment of MESCC and should facilitate referral of patients with MESCC for surgical evaluation.

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

    Science.gov (United States)

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

    2017-08-01

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

  12. Utilization of Patient-Reported Outcomes to Guide Symptom Management during Stereotactic Body Radiation Therapy for Clinically Localized Prostate Cancer

    Directory of Open Access Journals (Sweden)

    Malika Danner

    2017-10-01

    Full Text Available IntroductionUtilization of patient-reported outcomes (PROs to guide symptom management during radiation therapy is increasing. This study focuses on the use of the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP as a tool to assess urinary and bowel bother during stereotactic body radiation therapy (SBRT and its utility in guiding medical management.MethodsBetween September 2015 and January 2017, 107 patients with clinically localized prostate cancer were treated with 35–36.25 Gy via SBRT in five fractions. PROs were assessed using EPIC-CP 1 h prior to the first fraction and after each subsequent fraction. Symptom management medications were prescribed based on the physician clinical judgment or if patients reported a moderate to big problem. Clinical significance was assessed using a minimally important difference of 1/2 SD from baseline score.ResultsA median baseline EPIC-CP urinary symptom score of 1.5 significantly increased to 3.7 on the day of the final treatment (p < 0.0001. Prior to treatment, 9.3% of men felt that their overall urinary function was a moderate to big problem that increased to 28% by the end of the fifth treatment. A median baseline EPIC-CP bowel symptom score of 0.3 significantly increased to 1.4 on the day of the final treatment (p < 0.0001. Prior to treatment, 1.9% of men felt that their overall bowel function was a moderate to big problem that increased to 3.7% by the end of the fifth treatment. The percentage of patients requiring an increased dose of alpha-antagonist increased to 47% by the end of treatment, and an additional 28% of patients required a short steroid taper to manage moderate to big urinary problems. Similarly, the percentage of patients requiring antidiarrheals reached 12% by the fifth treatment.ConclusionDuring the course of SBRT, an increasing percentage of patients experienced clinically significant symptoms many of which required medical management

  13. Radiation Therapy Versus No Radiation Therapy to the Neo-breast Following Skin-Sparing Mastectomy and Immediate Autologous Free Flap Reconstruction for Breast Cancer: Patient-Reported and Surgical Outcomes at 1 Year-A Mastectomy Reconstruction Outcomes Consortium (MROC) Substudy.

    Science.gov (United States)

    Cooke, Andrew L; Diaz-Abele, Julian; Hayakawa, Tom; Buchel, Ed; Dalke, Kimberly; Lambert, Pascal

    2017-09-01

    To determine whether adjuvant radiation therapy (RT) is associated with adverse patient-reported outcomes and surgical complications 1 year after skin-sparing mastectomy and immediate autologous free flap reconstruction for breast cancer. We compared 24 domains of patient-reported outcome measures 1 year after autologous reconstruction between patients who received adjuvant RT and those who did not. A total of 125 patients who underwent surgery between 2012 and 2015 at our institution were included from the Mastectomy Reconstruction Outcomes Consortium study database. Adjusted multivariate models were created incorporating RT technical data, age, cancer stage, estrogen receptor, chemotherapy, breast size, body mass index, and income to determine whether RT was associated with outcomes. At 1 year after surgery, European Organisation for Research and Treatment of Cancer (EORTC) Breast Cancer-Specific Quality of Life Questionnaire breast symptoms were significantly greater in 64 patients who received RT (8-point difference on 100-point ordinal scale, PBREAST-Q (Post-operative Reconstruction Module), Patient-Report Outcomes Measurement Information System Profile 29, McGill Pain Questionnaire-Short Form (MPQ-SF) score, Generalized Anxiety Disorder Scale, and Patient Health Questionnaire-were not statistically different between groups. Surgical complications were uncommon and did not differ by treatment. RT to the neo-breast compared with no RT following immediate autologous free flap reconstruction for breast cancer is well tolerated at 1 year following surgery despite patients undergoing RT also having a higher cancer stage and more intensive surgical and systemic treatment. Neo-breast symptoms are more common in patients receiving RT by the EORTC Breast Cancer-Specific Quality of Life Questionnaire but not by the BREAST-Q. Patient-reported results at 1 year after surgery suggest RT following immediate autologous free flap breast reconstruction is well tolerated

  14. Patient-reported outcomes and socioeconomic status as predictors of clinical outcomes following hematopoietic stem cell transplantation: A study from the BMT CTN 0902 trial

    Science.gov (United States)

    Knight, Jennifer M; Syrjala, Karen L; Majhail, Navneet S; Martens, Michael; Le-Rademacher, Jennifer; Logan, Brent R; Lee, Stephanie J; Jacobsen, Paul B; Wood, William A; Jim, Heather SL; Wingard, John R; Horowitz, Mary M; Abidi, Muneer H; Fei, Mingwei; Rawls, Laura; Rizzo, J Douglas

    2016-01-01

    This secondary analysis of a large, multi-center Blood and Marrow Transplant Clinical Trials Network (BMT CTN) randomized trial assessed whether patient-reported outcomes (PROs) and socioeconomic status (SES) before hematopoietic stem cell transplantation (HCT) are associated with each other and predictive of clinical outcomes including time to hematopoietic recovery, acute graft-versus-host disease, hospitalization days, and overall survival (OS) among 646 allogeneic and autologous HCT recipients. Pre-transplant Cancer and Treatment Distress (CTXD), Pittsburgh Sleep Quality Index (PSQI), and mental and physical component scores (MCS and PCS) of the SF-36 were correlated with each other and with SES variables. PROs and SES variables were further evaluated as predictors of clinical outcomes, with the PSQI and CTXD evaluated as OS predictors (pincome was related to worse physical functioning (p=.005) and increased distress (p=.008); lack of employment pre-transplant was associated with worse physical functioning (p<.01); unmarried status was associated with worse sleep (p=.003). In this large heterogeneous cohort of HCT recipients, while PROs and SES variables were correlated at baseline, they were not associated with any clinical outcomes. Future research should focus on HCT recipients at greater psychosocial disadvantage. PMID:27565521

  15. Surgery for the correction of hallux valgus: minimum five-year results with a validated patient-reported outcome tool and regression analysis.

    Science.gov (United States)

    Chong, A; Nazarian, N; Chandrananth, J; Tacey, M; Shepherd, D; Tran, P

    2015-02-01

    This study sought to determine the medium-term patient-reported and radiographic outcomes in patients undergoing surgery for hallux valgus. A total of 118 patients (162 feet) underwent surgery for hallux valgus between January 2008 and June 2009. The Manchester-Oxford Foot Questionnaire (MOXFQ), a validated tool for the assessment of outcome after surgery for hallux valgus, was used and patient satisfaction was sought. The medical records and radiographs were reviewed retrospectively. At a mean of 5.2 years (4.7 to 6.0) post-operatively, the median combined MOXFQ score was 7.8 (IQR:0 to 32.8). The median domain scores for pain, walking/standing, and social interaction were 10 (IQR: 0 to 45), 0 (IQR: 0 to 32.1) and 6.3 (IQR: 0 to 25) respectively. A total of 119 procedures (73.9%, in 90 patients) were reported as satisfactory but only 53 feet (32.7%, in 43 patients) were completely asymptomatic. The mean (SD) correction of hallux valgus, intermetatarsal, and distal metatarsal articular angles was 18.5° (8.8°), 5.7° (3.3°), and 16.6° (8.8°), respectively. Multivariable regression analysis identified that an American Association of Anesthesiologists grade of >1 (Incident Rate Ratio (IRR) = 1.67, p-value = 0.011) and recurrent deformity (IRR = 1.77, p-value = 0.003) were associated with significantly worse MOXFQ scores. No correlation was found between the severity of deformity, the type, or degree of surgical correction and the outcome. When using a validated outcome score for the assessment of outcome after surgery for hallux valgus, the long-term results are worse than expected when compared with the short- and mid-term outcomes, with 25.9% of patients dissatisfied at a mean follow-up of 5.2 years. ©2015 The British Editorial Society of Bone & Joint Surgery.

  16. Tofacitinib with conventional synthetic disease-modifying antirheumatic drugs in Chinese patients with rheumatoid arthritis: Patient-reported outcomes from a Phase 3 randomized controlled trial.

    Science.gov (United States)

    Li, Zhanguo; An, Yuan; Su, Houheng; Li, Xiangpei; Xu, Jianhua; Zheng, Yi; Li, Guiye; Kwok, Kenneth; Wang, Lisy; Wu, Qizhe

    2018-02-01

    Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We assess the effect of tofacitinib + conventional synthetic disease-modifying anti rheumatic drugs (csDMARDs) on patient-reported outcomes in Chinese patients with RA and inadequate response to DMARDs. This analysis of data from the Phase 3 study ORAL Sync included Chinese patients randomized 4 : 4 : 1 : 1 to receive tofacitinib 5 mg twice daily, tofacitinib 10 mg twice daily, placebo→tofacitinib 5 mg twice daily, or placebo→tofacitinib 10 mg twice daily, with csDMARDs. Placebo non-responders switched to tofacitinib at 3 months; the remaining placebo patients switched at 6 months. Least squares mean changes from baseline were reported for Health Assessment Questionnaire-Disability Index (HAQ-DI), patient assessment of arthritis pain (Pain), patient global assessment of disease activity (PtGA), physician global assessment of disease activity (PGA), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scores, Short Form 36 (SF-36), and Work Limitations Questionnaire (WLQ), using a mixed-effects model for repeated measures. Overall, 216 patients were included (tofacitinib 5 mg twice daily, n = 86; tofacitinib 10 mg twice daily, n = 86; placebo→tofacitinib 5 mg twice daily, n = 22; placebo→tofacitinib 10 mg twice daily, n = 22). At month 3, tofacitinib elicited significant improvements in HAQ-DI, Pain, PtGA, PGA and SF-36 Physical Component Summary scores. Improvements were generally maintained through 12 months. Tofacitinib 5 and 10 mg twice daily + csDMARDs resulted in improvements in health-related quality of life, physical function and Pain through 12 months in Chinese patients with RA. © 2018 The Authors. International Journal of Rheumatic Diseases published by Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.

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

    Directory of Open Access Journals (Sweden)

    Jahagirdar Deepa

    2012-11-01

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

  18. Development of a Symptom-Based Patient-Reported Outcome Instrument for Functional Dyspepsia: A Preliminary Conceptual Model and an Evaluation of the Adequacy of Existing Instruments.

    Science.gov (United States)

    Taylor, Fiona; Reasner, David S; Carson, Robyn T; Deal, Linda S; Foley, Catherine; Iovin, Ramon; Lundy, J Jason; Pompilus, Farrah; Shields, Alan L; Silberg, Debra G

    2016-10-01

    The aim was to document, from the perspective of the empirical literature, the primary symptoms of functional dyspepsia (FD), evaluate the extent to which existing questionnaires target those symptoms, and, finally, identify any missing evidence that would impact the questionnaires' use in regulated clinical trials to assess treatment efficacy claims intended for product labeling. A literature review was conducted to identify the primary symptoms of FD and existing symptom-based FD patient-reported outcome (PRO) instruments. Following a database search, abstracts were screened and articles were retrieved for review. The primary symptoms of FD were organized into a conceptual model and the PRO instruments were evaluated for conceptual coverage as well as compared against evidentiary requirements presented in the FDA's PRO Guidance for Industry. Fifty-six articles and 16 instruments assessing FD symptoms were reviewed. Concepts listed in the Rome III criteria for FD (n = 7), those assessed by existing FD instruments (n = 34), and symptoms reported by patients in published qualitative research (n = 6) were summarized in the FD conceptual model. Except for vomiting, all of the identified symptoms from the published qualitative research reports were also specified in the Rome III criteria. Only three of the 16 instruments, the Dyspepsia Symptom Severity Index (DSSI), Nepean Dyspepsia Index (NDI), and Short-Form Nepean Dyspepsia Index (SF-NDI), measure all seven FD symptoms defined by the Rome III criteria. Among these three, each utilizes a 2-week recall period and 5-point Likert-type scale, and had evidence of patient involvement in development. Despite their coverage, when these instruments were evaluated in light of regulatory expectations, several issues jeopardized their potential qualification for substantiation of a labeling claim. No existing PRO instruments that measured all seven symptoms adhered to the regulatory principles necessary to support product

  19. Impact of depressive symptoms on subjective well-being: the importance of patient-reported outcomes in schizophrenia

    Directory of Open Access Journals (Sweden)

    Haro JM

    2011-09-01

    when discriminating between depressive severity levels (0.84, followed by emotional regulation (0.80, social integration (0.78, physical functioning and self-control (0.77, and mental functioning (0.73. Total SWN-K and its five subscales showed a significant linear trend against CDSS severity levels (P < 0.001.Conclusion: The presence of moderate to severe depressive symptoms was relatively high, and correlated inversely with patients’ subjective well-being. Routine assessment of patient-reported measures in patients with schizophrenia might reduce potential discrepancy between patient and physician assessment, increase therapeutic alliance, and improve outcome.Keywords: schizophrenia, subjective well-being, patient-reported outcome, depressive symptoms 

  20. Feasibility and acceptability of electronic symptom surveillance with clinician feedback using the Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) in Danish prostate cancer patients

    DEFF Research Database (Denmark)

    Bæksted, Christina; Pappot, Helle; Nissen, Aase

    2017-01-01

    -CTCAE questionnaire on tablet computers using AmbuFlex software at each treatment visit in the outpatient clinic. In total, 22 symptomatic toxicities (41 PRO-CTCAE items), corresponding to the symptomatic adverse-events profile associated with the regimens commonly used for prostate cancer treatment (Docetaxel......Background: The aim was to examine the feasibility, acceptability and clinical utility of electronic symptom surveillance with clinician feedback using a subset of items drawn from the Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a cancer...

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

    DEFF Research Database (Denmark)

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

    2016-01-01

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

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

    Science.gov (United States)

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

    2017-12-01

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

  3. Establishment of a Web-based System for Collection of Patient-reported Outcomes After Radical Prostatectomy in a Statewide Quality Improvement Collaborative.

    Science.gov (United States)

    Lucas, Steven M; Kim, Tae-Kyung; Ghani, Khurshid R; Miller, David C; Linsell, Susan; Starr, Jay; Peabody, James O; Hurley, Patrick; Montie, James; Cher, Michael L

    2017-09-01

    To report on the establishment of a unified, electronic patient-reported outcome (PRO) infrastructure and pilot results from the first 5 practices enrolled in the web-based collection system developed by the Michigan Urological Surgery Improvement Collaborative. Eligible patients were those undergoing radical prostatectomy of 5 academic and community practices. PRO was obtained using a validated 21-item web-based questionnaire, regarding urinary function, erection function, and sexual interest and satisfaction. Data were collected preoperatively, at 3 months, and 6 months postoperatively. Patients were provided a link via email to complete the surveys. Perioperative and PRO data were analyzed as reports for individual patients and summary performance reports for individual surgeons. Among 773 eligible patients, 688 (89%) were enrolled preoperatively. Survey completion rate was 88%, 84%, and 90% preoperatively, at 3 months, and 6 months. Electronic completion rates preoperatively, at 3 months, and 6 months were 70%, 70%, and 68%, respectively. Mean urinary function scores were 18.3, 14.3, and 16.6 (good function ≥ 17), whereas mean erection scores were 18.7, 7.3, and 9.1 (good erection score ≥ 22) before surgery, at 3 months, and 6 months. Variation was noted for erectile function among the practices. Collection of electronic PRO via this unified, web-based format was successful and provided results that reflect expected recovery and identify opportunities for improvement. This will be extended to more practices statewide to improve outcomes after radical prostatectomy. Copyright © 2017 Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2016-12-01

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

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

    Science.gov (United States)

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

    2014-03-01

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

  6. Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST).

    Science.gov (United States)

    de Souza, Jonas A; Yap, Bonnie J; Wroblewski, Kristen; Blinder, Victoria; Araújo, Fabiana S; Hlubocky, Fay J; Nicholas, Lauren H; O'Connor, Jeremy M; Brockstein, Bruce; Ratain, Mark J; Daugherty, Christopher K; Cella, David

    2017-02-01

    Cancer and its treatment lead to increased financial distress for patients. To the authors' knowledge, to date, no standardized patient-reported outcome measure has been validated to assess this distress. Patients with AJCC Stage IV solid tumors receiving chemotherapy for at least 2 months were recruited. Financial toxicity was measured by the COmprehensive Score for financial Toxicity (COST) measure. The authors collected data regarding patient characteristics, clinical trial participation, health care use, willingness to discuss costs, psychological distress (Brief Profile of Mood States [POMS]), and health-related quality of life (HRQOL) as measured by the Functional Assessment of Cancer Therapy: General (FACT-G) and the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaires. Test-retest reliability, internal consistency, and validity of the COST measure were assessed using standard-scale construction techniques. Associations between the resulting factors and other variables were assessed using multivariable analyses. A total of 375 patients with advanced cancer were approached, 233 of whom (62.1%) agreed to participate. The COST measure demonstrated high internal consistency and test-retest reliability. Factor analyses revealed a coherent, single, latent variable (financial toxicity). COST values were found to be correlated with income (correlation coefficient [r] = 0.28; Pfinancial toxicity were race (P = .04), employment status (Pcosts was not found to be associated with the degree of financial distress (P = .49). The COST measure demonstrated reliability and validity in measuring financial toxicity. Its correlation with HRQOL indicates that financial toxicity is a clinically relevant patient-centered outcome. Cancer 2017;123:476-484. © 2016 American Cancer Society. © 2016 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.

  7. Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease - International Study (APPROACH-IS): rationale, design, and methods

    NARCIS (Netherlands)

    Apers, Silke; Kovacs, Adrienne H.; Luyckx, Koen; Alday, Luis; Berghammer, Malin; Budts, Werner; Callus, Edward; Caruana, Maryanne; Chidambarathanu, Shanthi; Cook, Stephen C.; Dellborg, Mikael; Enomoto, Junko; Eriksen, Katrine; Fernandes, Susan M.; Jackson, Jamie L.; Johansson, Bengt; Khairy, Paul; Kutty, Shelby; Menahem, Samuel; Rempel, Gwen; Sluman, Maayke A.; Soufi, Alexandra; Thomet, Corina; Veldtman, Gruschen; Wang, Jou-Kou; White, Kamila; Moons, Philip; Maisuls, Héctor; Cabrera, Marcelo; Eaton, Sarah; Larion, Ruth; FengWang, Qi; van Deyk, Kristien; Goossens, Eva; Rassart, Jessica; Mackie, Andrew; Ballantyne, Ross; Rankin, Kathryn; Norris, Colleen; Taylor, Dylan; Vondermuhll, Isabelle; Windram, Jonathan; Heggie, Pamela; Lasiuk, Gerri; Proietti, Anna; Dore, Annie; Mercier, Lise-Andrée; Mongeon, François-Pierre; Marcotte, François; Mulder, Barbara

    2015-01-01

    Data on patient-reported outcomes (PROs) in adults with congenital heart disease (CHD) are inconsistent and vary across the world. Better understanding of PROs and their differences across cultural and geographic barriers can best be accomplished via international studies using uniform research

  8. Cross-cultural validity of the thyroid-specific quality-of-life patient-reported outcome measure, ThyPRO

    NARCIS (Netherlands)

    Watt, T.; Barbesino, G.; Bjorner, J.B.; Bonnema, S.J.; Bukvic, B.; Drummond, R.; Groenvold, M.; Hegedus, L.; Kantzer, V.; Lasch, K.E.; Marcocci, C.; Mishra, A.; Netea-Maier, R.T.; Ekker, M.; Paunovic, I.; Quinn, T.J.; Rasmussen, A.K.; Russell, A.; Sabaretnam, M.; Smit, J.W.; Torring, O.; Zivaljevic, V.; Feldt-Rasmussen, U.

    2015-01-01

    BACKGROUND AND PURPOSE: Thyroid diseases are common and often affect quality of life (QoL). No cross-culturally validated patient-reported outcome measuring thyroid-related QoL is available. The purpose of the present study was to test the cross-cultural validity of the newly developed

  9. Patient-reported outcomes in adults with congenital heart disease: Inter-country variation, standard of living and healthcare system factors

    NARCIS (Netherlands)

    Moons, Philip; Kovacs, Adrienne H.; Luyckx, Koen; Thomet, Corina; Budts, Werner; Enomoto, Junko; Sluman, Maayke A.; Yang, Hsiao-Ling; Jackson, Jamie L.; Khairy, Paul; Cook, Stephen C.; Subramanyan, Raghavan; Alday, Luis; Eriksen, Katrine; Dellborg, Mikael; Berghammer, Malin; Johansson, Bengt; Mackie, Andrew S.; Menahem, Samuel; Caruana, Maryanne; Veldtman, Gruschen; Soufi, Alexandra; Fernandes, Susan M.; White, Kamila; Callus, Edward; Kutty, Shelby; van Bulck, Liesbet; Apers, Silke

    2018-01-01

    Aims: Geographical differences in patient-reported outcomes (PROs) of adults with congenital heart disease (ConHD) have been observed, but are poorly understood. We aimed to: (1) investigate inter-country variation in PROs in adults with ConHD; (2) identify patient-related predictors of PROs; and

  10. A new internet-based tool for reporting and analysing patient-reported outcomes and the feasibility of repeated data collection from patients with myeloproliferative neoplasms

    DEFF Research Database (Denmark)

    Brochmann, Nana; Zwisler, Ann-Dorthe; Kjerholt, Mette

    2016-01-01

    PURPOSE: An Internet-based tool for reporting and analysing patient-reported outcomes (PROs) has been developed. The tool enables merging PROs with blood test results and allows for computation of treatment responses. Data may be visualized by graphical analysis and may be exported for downstream...

  11. Individual Prognosis of Symptom Burden and Functioning in Chronic Diseases: A Generic Method Based on Patient-Reported Outcome (PRO) Measures

    DEFF Research Database (Denmark)

    Hjollund, Niels Henrik Ingvar

    2017-01-01

    BACKGROUND: Information to the patient about the long-term prognosis of symptom burden and functioning is an integrated part of clinical practice, but relies mostly on the clinician’s personal experience. Relevant prognostic models based on patient-reported outcome (PRO) data with repeated measur...

  12. Patient reported outcomes following stereotactic ablative radiotherapy or surgery for stage IA non-small-cell lung cancer : Results from the ROSEL multicenter randomized trial

    NARCIS (Netherlands)

    Louie, Alexander V.; van Werkhoven, Erik; Chen, Hanbo; Smit, Egbert F.; Paul, Marinus A.; Widder, Joachim; Groen, Harry J. M.; van den Borne, Ben E. E. M.; De Jaeger, Katrien; Slotman, Ben J.; Senan, Suresh

    2015-01-01

    We report quality of life and indirect costs from patient reported outcomes from the ROSEL randomized control trial comparing stereotactic ablative radiotherapy (SABR, also known as stereotactic body radiotherapy or SBRT) versus surgical resection for medically operable stage IA non-small cell lung

  13. Epoetin alfa improves anemia and anemia-related, patient-reported outcomes in patients with breast cancer receiving myelotoxic chemotherapy: Results of a european, multicenter, randomized, controlled trial

    NARCIS (Netherlands)

    P. Pronzato (Paolo); E. Cortesi (Enrico); C.C.D. van der Rijt (Carin); A. Bols (Alain); J.A. Moreno-Nogueira (José); C.F. de Oliveira; P. Barrett-Lee (Peter); P.J. Ostler (Peter); R. Rosso (Ricardo)

    2010-01-01

    textabstractPurpose. To evaluate the effects of epoetin alfa on patient- reported outcomes (PROs) in patients with breast cancer receiving myelotoxic chemotherapy. Materials and Methods. Women with hemoglobin concentrations ≤12.0 g/dl and an Eastern Cooperative Oncology Group performance status

  14. Healthcare Professionals' Preferences and Perceived Barriers for Routine Assessment of Patient-Reported Outcomes in Pediatric Oncology Practice: Moving Toward International Processes of Change

    NARCIS (Netherlands)

    Schepers, Sasja A.; Haverman, Lotte; Zadeh, Sima; Grootenhuis, Martha A.; Wiener, Lori

    2016-01-01

    Using patient-reported outcomes (PROs) in clinical practice has been shown to enhance detection of health-related quality of life problems and satisfaction with care in children with cancer. This study seeks to identify which PRO information healthcare professionals (HCPs) find useful and what the

  15. Quality of data entry using single entry, double entry and automated forms processing--an example based on a study of patient-reported outcomes

    DEFF Research Database (Denmark)

    Paulsen, Aksel; Overgaard, Søren; Lauritsen, Jens Martin

    2012-01-01

    The clinical and scientific usage of patient-reported outcome measures is increasing in the health services. Often paper forms are used. Manual double entry of data is defined as the definitive gold standard for transferring data to an electronic format, but the process is laborious. Automated...

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

    NARCIS (Netherlands)

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

    2012-01-01

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

  17. Scientific imperatives, clinical implications, and theoretical underpinnings for the investigation of the relationship between genetic variables and patient-reported quality-of-life outcomes

    NARCIS (Netherlands)

    Sprangers, Mirjam A. G.; Sloan, Jeff A.; Barsevick, Andrea; Chauhan, Cynthia; Dueck, Amylou C.; Raat, Hein; Shi, Quiling; van Noorden, Cornelis J. F.; Abernethy, Amy P.; Baas, Frank; Barsevick, Andrea M.; Bartels, Meike; Boomsma, Dorret I.; Bottomley, Andrew; Brundage, Michael; Cella, David; Cleeland, Charles S.; Coens, Corneel; Frost, Marlene H.; Hall, Per; Halyard, Michele Y.; Klepstad, Pål; Martin, Nicholas G.; Miaskowski, Christine; Mosing, Miriam; Movsas, Benjamin; Oliveira, Joao R.; Ordoñana, Juan; Patrick, Donald L.; Pedersen, Nancy L.; Reeve, Bryce; Ropka, Mary E.; Shinozaki, Gen; Singh, Jasvinder A.; Swaab, Dick; Veenhoven, Ruut; Wagner, Gert; Yang, Ping; Zwinderman, Ailko H.

    2010-01-01

    Objectives There is emerging evidence for a genetic basis of patient-reported quality-of-life (QOL) outcomes that can ultimately be incorporated into clinical research and practice. Objectives are (1) to provide arguments for the timeliness of investigating the genetic basis of QOL given the

  18. Development of the Flu-PRO: a patient-reported outcome (PRO) instrument to evaluate symptoms of influenza.

    Science.gov (United States)

    Powers, John H; Guerrero, M Lourdes; Leidy, Nancy Kline; Fairchok, Mary P; Rosenberg, Alice; Hernández, Andrés; Stringer, Sonja; Schofield, Christina; Rodríguez-Zulueta, Patricia; Kim, Katherine; Danaher, Patrick J; Ortega-Gallegos, Hilda; Bacci, Elizabeth Dansie; Stepp, Nathaniel; Galindo-Fraga, Arturo; St Clair, Kristina; Rajnik, Michael; McDonough, Erin A; Ridoré, Michelande; Arnold, John C; Millar, Eugene V; Ruiz-Palacios, Guillermo M

    2016-01-05

    To develop content validity of a comprehensive patient-reported outcome (PRO) measure following current best scientific methodology to standardize assessment of influenza (flu) symptoms in clinical research. Stage I (Concept Elicitation): 1:1 telephone interviews with influenza-positive adults (≥18 years) in the US and Mexico within 7 days of diagnosis. Participants described symptom type, character, severity, and duration. Content analysis identified themes and developed the draft Flu-PRO instrument. Stage II (Cognitive Interviewing): The Flu-PRO was administered to a unique set of influenza-positive adults within 14 days of diagnosis; telephone interviews addressed completeness, respondent interpretation of items and ease of use. Samples: Stage I: N = 46 adults (16 US, 30 Mexico); mean (SD) age: 38 (19), 39 (14) years; % female: 56%, 73%; race: 69% White, 97% Mestizo. Stage II: N = 34 adults (12 US, 22 Mexico); age: 37 (14), 39 (11) years; % female: 50%, 50%; race: 58% White, 100% Mestizo. Symptoms identified by >50%: coughing, weak or tired, throat symptoms, congestion, headache, weakness, sweating, chills, general discomfort, runny nose, chest (trouble breathing), difficulty sleeping, and body aches or pains. No new content was uncovered during Stage II; participants easily understood the instrument. Results show the 37-item Flu-PRO is a content valid measure of influenza symptoms in adults with a confirmed diagnosis of influenza. Research is underway to evaluate the suitability of the instrument for children and adolescents. This work can form the basis for future quantitative tests of reliability, validity, and responsiveness to evaluate the measurement properties of Flu-PRO for use in clinical trials and epidemiology studies.

  19. Content Validity of Patient-Reported Outcome Instruments used with Pediatric Patients with Facial Differences: A Systematic Review.

    Science.gov (United States)

    Wickert, Natasha M; Wong Riff, Karen W Y; Mansour, Mark; Forrest, Christopher R; Goodacre, Timothy E E; Pusic, Andrea L; Klassen, Anne F

    2018-01-01

    Objective The aim of this systematic review was to identify patient-reported outcome (PRO) instruments used in research with children/youth with conditions associated with facial differences to identify the health concepts measured. Design MEDLINE, EMBASE, CINAHL, and PsycINFO were searched from 2004 to 2016 to identify PRO instruments used in acne vulgaris, birthmarks, burns, ear anomalies, facial asymmetries, and facial paralysis patients. We performed a content analysis whereby the items were coded to identify concepts and categorized as positive or negative content or phrasing. Results A total of 7,835 articles were screened; 6 generic and 11 condition-specific PRO instruments were used in 96 publications. Condition-specific instruments were for acne (four), oral health (two), dermatology (one), facial asymmetries (two), microtia (one), and burns (one). The PRO instruments provided 554 items (295 generic; 259 condition specific) that were sorted into 4 domains, 11 subdomains, and 91 health concepts. The most common domain was psychological (n = 224 items). Of the identified items, 76% had negative content or phrasing (e.g., "Because of the way my face looks I wish I had never been born"). Given the small number of items measuring facial appearance (n = 19) and function (n = 22), the PRO instruments reviewed lacked content validity for patients whose condition impacted facial function and/or appearance. Conclusions Treatments can change facial appearance and function. This review draws attention to a problem with content validity in existing PRO instruments. Our team is now developing a new PRO instrument called FACE-Q Kids to address this problem.

  20. Measuring IBS patient reported outcomes with an abdominal pain numeric rating scale: results from the proof cohort

    Science.gov (United States)

    SPIEGEL, B.; BOLUS, R.; HARRIS, L. A.; LUCAK, S.; NALIBOFF, B.; ESRAILIAN, E.; CHEY, W. D.; LEMBO, A.; KARSAN, H.; TILLISCH, K.; TALLEY, J.; MAYER, E.; CHANG, L.

    2009-01-01

    Background Controversy exists about how to effectively measure patient reported outcomes in IBS clinical trials. Pain numeric rating scales (NRS) are widely used in the non-IBS pain literature. The FDA has proposed using the NRS in IBS. Aim To test the psychometrics of an abdominal pain NRS in IBS. Methods We analyzed data from a longitudinal cohort of Rome III IBS subjects. At entry, subjects completed a 10-point NRS, bowel symptoms, IBS severity measurements (IBSSS, FBDSI), health related quality of life indices (IBS-QOL, EQ5D), and the worker productivity activity index (WPAI). We repeated assessments at 3 months along with a response scale to calculate the minimal clinically important difference (MCID). Results There were 277 subjects (82% women; age=42±15) at baseline and 90 at 3 months. The NRS correlated cross-sectionally with IBSSS (r=0.60; p<0.0011), FBDSI (r=0.49; p<0.0001), IBS-QOL (r=0.43; p<0.0001), EQ5D (r=0.48; p<0.0001), presenteeism (r=0.39; p<0.0001), absenteeism (r=0.17; p=0.04), and distension (r=0.46; p<0.0001), but not stool frequency or form. The MCID was 2.2 points, correlating with a 29.5% reduction over time. Conclusions An abdominal pain NRS exhibits excellent validity and can be readily interpreted with an MCID in patients with IBS. These data support the use of the NRS in IBS clinical trials. PMID:19751360

  1. Retrospective study of the effect of disease progression on patient reported outcomes in HER-2 negative metastatic breast cancer patients

    Directory of Open Access Journals (Sweden)

    Yu Elaine

    2011-06-01

    Full Text Available Abstract Background This retrospective study evaluated the impact of disease progression and of specific sites of metastasis on patient reported outcomes (PROs that assess symptom burden and health related quality of life (HRQoL in women with metastatic breast cancer (mBC. Methods HER-2 negative mBC patients (n = 102 were enrolled from 7 U.S. community oncology practices. Demographic, disease and treatment characteristics were abstracted from electronic medical records and linked to archived Patient Care Monitor (PCM assessments. The PCM is a self-report measure of symptom burden and HRQoL administered as part of routine care in participating practices. Linear mixed models were used to examine change in PCM scores over time. Results Mean age was 57 years, with 72% of patients Caucasian, and 25% African American. Median time from mBC diagnosis to first disease progression was 8.8 months. Metastasis to bone (60%, lung (28% and liver (26% predominated at initial metastatic diagnosis. Results showed that PCM items assessing fatigue, physical pain and trouble sleeping were sensitive to either general effects of disease progression or to effects associated with specific sites of metastasis. Progression of disease was also associated with modest but significant worsening of General Physical Symptoms, Treatment Side Effects, Acute Distress and Impaired Performance index scores. In addition, there were marked detrimental effects of liver metastasis on Treatment Side Effects, and of brain metastasis on Acute Distress. Conclusions Disease progression has a detrimental impact on cancer-related symptoms. Delaying disease progression may have a positive impact on patients' HRQoL.

  2. An Item Bank for Abuse of Prescription Pain Medication 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; Hilton, Thomas F; Daley, Dennis C; Patkar, Ashwin A; McCarty, Dennis

    2017-08-01

    There is a need to monitor patients receiving prescription opioids to detect possible signs of abuse. To address this need, we developed and calibrated an item bank for severity of abuse of prescription pain medication as part of the Patient-Reported Outcomes Measurement Information System (PROMIS ® ). Comprehensive literature searches yielded an initial bank of 5,310 items relevant to substance use and abuse, including abuse of prescription pain medication, from over 80 unique instruments. After qualitative item analysis (i.e., focus groups, cognitive interviewing, expert review, and item revision), 25 items for abuse of prescribed pain medication were included in field testing. Items were written in a first-person, past-tense format, with a three-month time frame and five response options reflecting frequency or severity. The calibration sample included 448 respondents, 367 from the general population (ascertained through an internet panel) and 81 from community treatment programs participating in the National Drug Abuse Treatment Clinical Trials Network. A final bank of 22 items was calibrated using the two-parameter graded response model from item response theory. A seven-item static short form was also developed. The test information curve showed that the PROMIS ® item bank for abuse of prescription pain medication provided substantial information in a broad range of severity. The initial psychometric characteristics of the item bank support its use as a computerized adaptive test or short form, with either version providing a brief, precise, and efficient measure relevant to both clinical and community samples. © 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  3. Patient-reported outcome (PRO assessment in clinical trials: a systematic review of guidance for trial protocol writers.

    Directory of Open Access Journals (Sweden)

    Melanie Calvert

    Full Text Available Evidence suggests there are inconsistencies in patient-reported outcome (PRO assessment and reporting in clinical trials, which may limit the use of these data to inform patient care. For trials with a PRO endpoint, routine inclusion of key PRO information in the protocol may help improve trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. The aim of this review was to summarize the current PRO-specific guidance for clinical trial protocol developers.We searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013 for PRO-specific guidance regarding trial protocol development. Further guidance documents were identified via Google, Google scholar, requests to members of the UK Clinical Research Collaboration registered clinical trials units and international experts. Two independent investigators undertook title/abstract screening, full text review and data extraction, with a third involved in the event of disagreement. 21,175 citations were screened and 54 met the inclusion criteria. Guidance documents were difficult to access: electronic database searches identified just 8 documents, with the remaining 46 sourced elsewhere (5 from citation tracking, 27 from hand searching, 7 from the grey literature review and 7 from experts. 162 unique PRO-specific protocol recommendations were extracted from included documents. A further 10 PRO recommendations were identified relating to supporting trial documentation. Only 5/162 (3% recommendations appeared in ≥50% of guidance documents reviewed, indicating a lack of consistency.PRO-specific protocol guidelines were difficult to access, lacked consistency and may be challenging to implement in practice. There is a need to develop easily accessible consensus-driven PRO protocol guidance. Guidance should be aimed at ensuring key PRO information is routinely included in

  4. Cross-cultural validation of a disease-specific patient-reported outcome measure for lupus in Philippines.

    Science.gov (United States)

    Navarra, S V; Tanangunan, R M D V; Mikolaitis-Preuss, R A; Kosinski, M; Block, J A; Jolly, M

    2013-03-01

    LupusPRO is a disease-targeted patient-reported outcome measure that was developed and validated among US patients with systemic lupus erythematosus (SLE). We report the cross-cultural validation results of the LupusPRO English-language version among Filipino SLE patients. The 43-item LupusPRO was pretested in 15 SLE individuals, then administered to 106 SLE patients, along with short-form SF36 and the EQ5D visual analogue scale. A mail/drop-back LupusPRO and change in health status item survey were returned within two to three days. Demographics, clinical and serological characteristics, disease activity and damage measured by PGA, SELENA-SLEDAI, LFA Flare, and SLICC-ACR SLE damage index (SDI) were collected. Internal consistency reliability (ICR), test-retest reliability (TRT), convergent validity (corresponding SF36 domains) and criterion validity (against general health and disease activity measures) were tested. Reported p values are two tailed. A total of 121 Filipino SLE subjects (95% women, median age 31.0 ± 16 years) with at least a high school level of English instruction participated. Median (IQR) PGA, SLEDAI and SDI were 0.0 (1.0), 2.0 (10) and 0 (1), respectively. ICR exceeded 0.7 for all domains except the lupus symptoms domain. TRT was greater than 0.85 for all LupusPRO domains. Convergent and criterion validity were observed against corresponding SF36 domains and disease activity measures. The tool was well received by patients. Confirmatory factor analysis showed good fit. English LupusPRO has fair psychometric properties among SLE patients in the Philippines, and is now available for inclusion in clinical trials and longitudinal studies to test responsiveness to change.

  5. Reliability and validity of the Health Outcomes Burn Questionnaire for infants and children in The Netherlands

    NARCIS (Netherlands)

    van Baar, M. E.; Essink-Bot, M. L.; Oen, I. M. M. H.; Dokter, J.; Boxma, H.; Hinson, M. I.; van Loey, N. E. E.; Faber, A. W.; van Beeck, E. F.

    2006-01-01

    The Health Outcomes Burn Questionnaire (HOBQ) is a self-administered questionnaire to monitor outcome after burns in young children. This study aimed to assess feasibility, reliability and validity of the Dutch version of the HOBQ. The HOBQ was adapted into Dutch and tested in a population of

  6. Comparison of paper and electronic surveys for measuring patient-reported outcomes after anterior cruciate ligament reconstruction.

    Science.gov (United States)

    Bojcic, Jamie L; Sue, Valerie M; Huon, Tomy S; Maletis, Gregory B; Inacio, Maria C S

    2014-01-01

    This study compared response rates of paper and electronic versions of the Knee injury Osteoarthritis and Outcome Score questionnaire and examined the characteristics of patients who responded to each survey method. A total of 1486 patients registered by the Kaiser Permanente Anterior Cruciate Ligament Reconstruction Registry between 2005 and 2010 were included in this study. Response rates by survey modality for the overall cohort, by the specific time periods, and by age and sex at time of anterior cruciate ligament reconstruction were compared using χ(2) tests or the Fisher exact test when appropriate. Independent Student t tests were used to compare the Knee injury Osteoarthritis and Outcome Scores of survey respondents. The overall survey response rate was 42%. The 36% response rate in the electronic-survey group was significantly higher than the 22% response rate in the paper-survey group (p survey produced higher response rates, it is not sufficient alone to replace the traditional paper version among this Kaiser Permanente population.

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

    Science.gov (United States)

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

    2015-12-01

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

  8. Patient-reported outcome measures for systemic lupus erythematosus clinical trials: a review of content validity, face validity and psychometric performance.

    Science.gov (United States)

    Holloway, Laura; Humphrey, Louise; Heron, Louise; Pilling, Claire; Kitchen, Helen; Højbjerre, Lise; Strandberg-Larsen, Martin; Hansen, Brian Bekker

    2014-07-22

    Despite overall progress in treatment of autoimmune diseases, patients with systemic lupus erythematosus (SLE) experience many inflammatory symptoms representing an unmet medical need. This study aimed to create a conceptual model of the humanistic and economic burden of SLE, and review the patient-reported outcomes (PROs) used to measure such concepts in SLE clinical trials. A conceptual model for SLE was developed from structured review of published articles from 2007 to August 2013 identified from literature databases (MEDLINE, EMBASE, PsycINFO, EconLit) plus other sources (PROLabels, FDA/EMA websites, Clinicaltrials.gov). PROs targeting key symptoms/impacts were identified from the literature. They were reviewed in the context of available guidance and assessed for face and content validity and psychometric properties to determine appropriateness for use in SLE trials. The conceptual model identified fatigue, pain, cognition, daily activities, emotional well-being, physical/social functioning and work productivity as key SLE concepts. Of the 68 articles reviewed, 38 reported PRO data. From these and the other sources, 15 PROs were selected for review, including SLE-specific health-related quality of life (HRQoL) measures (n = 5), work productivity (n = 1), and generic measures of fatigue (n = 3), pain (n = 2), depression (n = 2) and HRQoL (n = 2). The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue), Brief Pain Inventory (BPI-SF) and LupusQoL demonstrated the strongest face validity, conceptual coverage and psychometric properties measuring key concepts in the conceptual model. All PROs reviewed, except for three Lupus-specific measures, lacked qualitative SLE patient involvement during development. The Hospital Anxiety and Depression Scale (HADS), Short Form [36 item] Health Survey version 2 (SF-36v2), EuroQoL 5-dimensions (EQ-5D-3L and EQ-5D-5L) and Work Productivity and Activity Impairment Questionnaire: Lupus (WPAI

  9. Patient-reported outcome measures for systemic lupus erythematosus clinical trials: a review of content validity, face validity and psychometric performance

    Science.gov (United States)

    2014-01-01

    Background Despite overall progress in treatment of autoimmune diseases, patients with systemic lupus erythematosus (SLE) experience many inflammatory symptoms representing an unmet medical need. This study aimed to create a conceptual model of the humanistic and economic burden of SLE, and review the patient-reported outcomes (PROs) used to measure such concepts in SLE clinical trials. Methods A conceptual model for SLE was developed from structured review of published articles from 2007 to August 2013 identified from literature databases (MEDLINE, EMBASE, PsycINFO, EconLit) plus other sources (PROLabels, FDA/EMA websites, Clinicaltrials.gov). PROs targeting key symptoms/impacts were identified from the literature. They were reviewed in the context of available guidance and assessed for face and content validity and psychometric properties to determine appropriateness for use in SLE trials. Results The conceptual model identified fatigue, pain, cognition, daily activities, emotional well-being, physical/social functioning and work productivity as key SLE concepts. Of the 68 articles reviewed, 38 reported PRO data. From these and the other sources, 15 PROs were selected for review, including SLE-specific health-related quality of life (HRQoL) measures (n = 5), work productivity (n = 1), and generic measures of fatigue (n = 3), pain (n = 2), depression (n = 2) and HRQoL (n = 2). The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue), Brief Pain Inventory (BPI-SF) and LupusQoL demonstrated the strongest face validity, conceptual coverage and psychometric properties measuring key concepts in the conceptual model. All PROs reviewed, except for three Lupus-specific measures, lacked qualitative SLE patient involvement during development. The Hospital Anxiety and Depression Scale (HADS), Short Form [36 item] Health Survey version 2 (SF-36v2), EuroQoL 5-dimensions (EQ-5D-3L and EQ-5D-5L) and Work Productivity and

  10. Validity, Reliability And Responsiveness Of Patient-Reported Outcome Questionnaires When Assessing Hip And Groin Disability: A Systematic Review

    DEFF Research Database (Denmark)

    Thorborg, Kristian; Roos, Ewa; Bartels, Else Marie

    2010-01-01

    disability based on a systematic review of evidence of validity, reliability and responsiveness of these instruments. Methods MEDLINE, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, PsycINFO, SportsDiscus and Web of Science were all searched up to January 2009. Two reviewers independently...

  11. Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension.

    Science.gov (United States)

    Calvert, Melanie; Kyte, Derek; Mercieca-Bebber, Rebecca; Slade, Anita; Chan, An-Wen; King, Madeleine T; Hunn, Amanda; Bottomley, Andrew; Regnault, Antoine; Chan, An-Wen; Ells, Carolyn; O'Connor, Daniel; Revicki, Dennis; Patrick, Donald; Altman, Doug; Basch, Ethan; Velikova, Galina; Price, Gary; Draper, Heather; Blazeby, Jane; Scott, Jane; Coast, Joanna; Norquist, Josephine; Brown, Julia; Haywood, Kirstie; Johnson, Laura Lee; Campbell, Lisa; Frank, Lori; von Hildebrand, Maria; Brundage, Michael; Palmer, Michael; Kluetz, Paul; Stephens, Richard; Golub, Robert M; Mitchell, Sandra; Groves, Trish

    2018-02-06

    Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence to inform shared decision making, labeling claims, clinical guidelines, and health policy; however, the PRO content of clinical trial protocols is often suboptimal. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was published in 2013 and aims to improve the completeness of trial protocols by providing evidence-based recommendations for the minimum set of items to be addressed, but it does not provide PRO-specific guidance. To develop international, consensus-based, PRO-specific protocol guidance (the SPIRIT-PRO Extension). The SPIRIT-PRO Extension was developed following the Enhancing Quality and Transparency of Health Research (EQUATOR) Network's methodological framework for guideline development. This included (1) a systematic review of existing PRO-specific protocol guidance to generate a list of potential PRO-specific protocol items (published in 2014); (2) refinements to the list and removal of duplicate items by the International Society for Quality of Life Research (ISOQOL) Protocol Checklist Taskforce; (3) an international stakeholder survey of clinical trial research personnel, PRO methodologists, health economists, psychometricians, patient advocates, funders, industry representatives, journal editors, policy makers, ethicists, and researchers responsible for evidence synthesis (distributed by 38 international partner organizations in October 2016); (4) an international Delphi exercise (n = 137 invited; October 2016 to February 2017); and (5) consensus meeting (n = 30 invited; May 2017). Prior to voting, consensus meeting participants were informed of the results of the Delphi exercise and given data from structured reviews evaluating the PRO protocol content of 3 defined samples of trial protocols. The systematic review identified 162 PRO-specific protocol recommendations from 54 sources. The ISOQOL Taskforce (n

  12. Reliability of patient-reported outcome instruments in US adults with hemophilia: the Pain, Functional Impairment and Quality of life (P-FiQ study

    Directory of Open Access Journals (Sweden)

    Kempton CL

    2017-09-01

    Full Text Available Christine L Kempton,1 Michael Wang,2 Michael Recht,3 Anne Neff,4 Amy D Shapiro,5 Amit Soni,6 Roshni Kulkarni,7 Tyler W Buckner,2 Katharine Batt,8 Neeraj N Iyer,9 David L Cooper9 1Departments of Pediatrics and Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, GA, USA; 2Hemophilia and Thrombosis Center, University of Colorado School of Medicine, Aurora, CO, USA; 3The Hemophilia Center, Oregon Health & Science University, Portland, OR, USA; 4Hematology and Medical Oncology, Cleveland Clinic, Cleveland, OH, USA; 5Indiana Hemophilia & Thrombosis Center, Indianapolis, IN, USA; 6Center for Inherited Blood Disorders and CHOC Children’s Hospital/UC Irvine, Orange, CA, USA; 7MSU Center for Bleeding and Clotting Disorders, Michigan State University, East Lansing, MI, USA; 8Hematology and Oncology, Wake Forest School of Medicine, Winston-Salem, NC, USA; 9Clinical, Medical and Regulatory Affairs, Novo Nordisk Inc., Plainsboro, NJ, USA Background: Hemophilia is marked by frequent joint bleeding, resulting in pain and functional impairment.Objective: This study aimed to assess the reliability of five patient-reported outcome (PRO instruments in people with hemophilia (PWH in a non-bleeding state.Methods: Adult male PWH of any severity and inhibitor status, with a history of joint pain or bleeding, completed a pain history and five PRO instruments (EQ-5D-5L, Brief Pain Inventory v2 [BPI], International Physical Activity Questionnaire [IPAQ], Short Form 36 Health Survey v2 [SF-36v2], and Hemophilia Activities List [HAL] during their routine comprehensive care visit. Patients were approached to complete the PRO instruments again at the end of their visit while in a similar non-bleeding state. Concordance of individual questionnaire items and correlation between domain scores were assessed using intra-class correlation coefficient (ICC.Results: Participants completing the retest (n=164 had a median age of 33.9 years. Median time for

  13. Qualitative development of a patient-reported outcome symptom measure in diarrhea-predominant irritable bowel syndrome.

    Science.gov (United States)

    Marquis, P; Lasch, K E; Delgado-Herrera, L; Kothari, S; Lembo, A; Lademacher, C; Spears, G; Nishida, A; Tesler, Waldman L; Piault, E; Rosa, K; Zeiher, B

    2014-06-26

    Despite a documented clinical need, no patient reported outcome (PRO) symptom measure meeting current regulatory requirements for clinically relevant end points is available for the evaluation of treatment benefit in diarrhea-predominant IBS (IBS-D). Patients (N=113) with IBS-D participated in five study phases: (1) eight concept elicitation focus groups (N=34), from which a 17-item IBS-D Daily Symptom Diary and four-item IBS-D Symptom Event Log (Diary and Event Log) were developed; (2) one-on-one cognitive interviews (N=11) to assess the instrument's comprehensiveness, understandability, appropriateness, and readability; (3) four data triangulation focus groups (N=32) to confirm the concepts elicited; (4) two hybrid (concept elicitation and cognitive interview) focus groups (N=16); and (5) two iterative sets of one-on-one cognitive interviews (N=20) to further clarify the symptoms of IBS-D and debrief a revised seven-item Diary and four-item Event Log. Of thirty-six concepts initially identified, 22 were excluded because they were not saturated, not clinically relevant, not critical symptoms of IBS-D, considered upper GI symptoms, or too broad or vaguely defined. The remaining concepts were diarrhea, immediate need (urgency), bloating/pressure, frequency of bowel movements, cramps, abdominal/stomach pain, gas, completely emptied bowels/incomplete evacuation, accidents, bubbling in intestines (bowel sounds), rectal burning, stool consistency, rectal spasm, and pain while wiping. The final instrument included a daily diary with separate items for abdominal and stomach pain and an event log with four items completed after each bowel movement as follows: (1) a record of the bowel movement/event and an assessment of (2) severity of immediacy of need/bowel urgency, (3) incomplete evacuation, and (4) stool consistency (evaluated using the newly developed Astellas Stool Form Scale). Based on rounds of interviews and clinical input, items considered secondary or

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

    Science.gov (United States)

    Hepworth, Lauren R; Rowe, Fiona J

    2018-02-01

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

  15. Patient-reported Outcomes in Randomised Controlled Trials of Prostate Cancer: Methodological Quality and Impact on Clinical Decision Making

    Science.gov (United States)

    Efficace, Fabio; Feuerstein, Michael; Fayers, Peter; Cafaro, Valentina; Eastham, James; Pusic, Andrea; Blazeby, Jane

    2014-01-01

    Context Patient-reported outcomes (PRO) data from randomised controlled trials (RCTs) are increasingly used to inform patient-centred care as well as clinical and health policy decisions. Objective The main objective of this study was to investigate the methodological quality of PRO assessment in RCTs of prostate cancer (PCa) and to estimate the likely impact of these studies on clinical decision making. Evidence acquisition A systematic literature search of studies was undertaken on main electronic databases to retrieve articles published between January 2004 and March 2012. RCTs were evaluated on a predetermined extraction form, including (1) basic trial demographics and clinical and PRO characteristics; (2) level of PRO reporting based on the recently published recommendations by the International Society for Quality of Life Research; and (3) bias, assessed using the Cochrane Risk of Bias tool. Studies were systematically analysed to evaluate their relevance for supporting clinical decision making. Evidence synthesis Sixty-five RCTs enrolling a total of 22 071 patients were evaluated, with 31 (48%) in patients with nonmetastatic disease. When a PRO difference between treatments was found, it related in most cases to symptoms only (n = 29, 58%). Although the extent of missing data was generally documented (72% of RCTs), few reported details on statistical handling of this data (18%) and reasons for dropout (35%). Improvements in key methodological aspects over time were found. Thirteen (20%) RCTs were judged as likely to be robust in informing clinical decision making. Higher-quality PRO studies were generally associated with those RCTs that had higher internal validity. Conclusions Including PRO in RCTs of PCa patients is critical for better evaluating the treatment effectiveness of new therapeutic approaches. Marked improvements in PRO quality reporting over time were found, and it is estimated that at least one-fifth of PRO RCTs have provided sufficient

  16. Qualitative Development of a Patient-Reported Outcome Symptom Measure in Diarrhea-Predominant Irritable Bowel Syndrome

    Science.gov (United States)

    Marquis, P; Lasch, K E; Delgado-Herrera, L; Kothari, S; Lembo, A; Lademacher, C; Spears, G; Nishida, A; Tesler, Waldman L; Piault, E; Rosa, K; Zeiher, B

    2014-01-01

    OBJECTIVES: Despite a documented clinical need, no patient reported outcome (PRO) symptom measure meeting current regulatory requirements for clinically relevant end points is available for the evaluation of treatment benefit in diarrhea-predominant IBS (IBS-D). METHODS: Patients (N=113) with IBS-D participated in five study phases: (1) eight concept elicitation focus groups (N=34), from which a 17-item IBS-D Daily Symptom Diary and four-item IBS-D Symptom Event Log (Diary and Event Log) were developed; (2) one-on-one cognitive interviews (N=11) to assess the instrument's comprehensiveness, understandability, appropriateness, and readability; (3) four data triangulation focus groups (N=32) to confirm the concepts elicited; (4) two hybrid (concept elicitation and cognitive interview) focus groups (N=16); and (5) two iterative sets of one-on-one cognitive interviews (N=20) to further clarify the symptoms of IBS-D and debrief a revised seven-item Diary and four-item Event Log. RESULTS: Of thirty-six concepts initially identified, 22 were excluded because they were not saturated, not clinically relevant, not critical symptoms of IBS-D, considered upper GI symptoms, or too broad or vaguely defined. The remaining concepts were diarrhea, immediate need (urgency), bloating/pressure, frequency of bowel movements, cramps, abdominal/stomach pain, gas, completely emptied bowels/incomplete evacuation, accidents, bubbling in intestines (bowel sounds), rectal burning, stool consistency, rectal spasm, and pain while wiping. The final instrument included a daily diary with separate items for abdominal and stomach pain and an event log with four items completed after each bowel movement as follows: (1) a record of the bowel movement/event and an assessment of (2) severity of immediacy of need/bowel urgency, (3) incomplete evacuation, and (4) stool consistency (evaluated using the newly developed Astellas Stool Form Scale). Based on rounds of interviews and clinical input, items

  17. www.common-metrics.org: a web application to estimate scores from different patient-reported outcome measures on a common scale.

    Science.gov (United States)

    Fischer, H Felix; Rose, Matthias

    2016-10-19

    Recently, a growing number of Item-Response Theory (IRT) models has been published, which allow estimation of a common latent variable from data derived by different Patient Reported Outcomes (PROs). When using data from different PROs, direct estimation of the latent variable has some advantages over the use of sum score conversion tables. It requires substantial proficiency in the field of psychometrics to fit such models using contemporary IRT software. We developed a web application ( http://www.common-metrics.org ), which allows estimation of latent variable scores more easily using IRT models calibrating different measures on instrument independent scales. Currently, the application allows estimation using six different IRT models for Depression, Anxiety, and Physical Function. Based on published item parameters, users of the application can directly estimate latent trait estimates using expected a posteriori (EAP) for sum scores as well as for specific response patterns, Bayes modal (MAP), Weighted likelihood estimation (WLE) and Maximum likelihood (ML) methods and under three different prior distributions. The obtained estimates can be downloaded and analyzed using standard statistical software. This application enhances the usability of IRT modeling for researchers by allowing comparison of the latent trait estimates over different PROs, such as the Patient Health Questionnaire Depression (PHQ-9) and Anxiety (GAD-7) scales, the Center of Epidemiologic Studies Depression Scale (CES-D), the Beck Depression Inventory (BDI), PROMIS Anxiety and Depression Short Forms and others. Advantages of this approach include comparability of data derived with different measures and tolerance against missing values. The validity of the underlying models needs to be investigated in the future.

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

    Science.gov (United States)

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

    2016-10-12

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

  19. [Patient reported outcome of tyrosine kinase inhibitor related side effects and their impact on daily life in Chinese patients with chronic myeloid leukemia in the chronic phase].

    Science.gov (United States)

    Yu, L; Wang, H B; Jiang, Q

    2016-11-14

    Objective: To explore the impact of patient reported outcome of tyrosine kinase inhibitor (TKI) related side effects on daily life in Chinese patients with chronic myeloid leukemia (CML) in the chronic phase (CP). Methods: From May to November in 2014, anonymous questionnaires were distributed to adult CML patients who were receiving TKI treatment in China. The impact of TKI-related side effects on daily life were assessed by the score of 1 (no impact) to 5 (high impact) from patient self-report. Results: Data from 731 respondents in the CP who reported the score of the impact of TKI-related side effects on daily life were collected. 407 (56%) were male. The median age was 41 years (range, 18 to 88 years). 560 (77%) started TKI treatment within 1 year after diagnosis. With a median treatment duration of 3 years (range, effects were edema ( n =323, 44% ), fatigue ( n =277, 38% ), gastrointestinal disorders ( n =235, 32% ), skin color changes ( n =142, 19% ), muscle cramps ( n =137, 19% ), rash ( n =105, 14% ), hepatic function abnormalities ( n =91, 12%), weight gain ( n =86, 12%), and cytopenia ( n =59, 8%). Multivariate analyses showed that TKI treatment duration effects on daily life in 218 (30%)respondents (1 score). 375 (51%)respondents reported their daily life were slightly or moderately decreased (2 or 3 score), while 138 (19%) significantly decreased (4 or 5 score). Multivariate analyses showed that female, ≥40 years old, use of generic TKI, TKI treatment duration negative effect on their daily life. When taking TKI related side-effects into considderation, secondary school and below, use of generic TKI, TKI treatment duration negative effect on their daily life. Conclusion: Edema, fatigue, gastrointestinal disorders, rash, skin color changes and hepatic function abnormalities were common TKI-related side effects and influenced CML patients' daily life in China. In addition, female, older age, lower education level, use of generic TKI and shorter TKI

  20. Validity and Reliability of the U.S. National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    Science.gov (United States)

    Dueck, Amylou C.; Mendoza, Tito R.; Mitchell, Sandra A.; Reeve, Bryce B.; Castro, Kathleen M.; Rogak, Lauren J.; Atkinson, Thomas M.; Bennett, Antonia V.; Denicoff, Andrea M.; O'Mara, Ann M.; Li, Yuelin; Clauser, Steven B.; Bryant, Donna M.; Bearden, James D.; Gillis, Theresa A.; Harness, Jay K.; Siegel, Robert D.; Paul, Diane B.; Cleeland, Charles S.; Schrag, Deborah; Sloan, Jeff A.; Abernethy, Amy P.; Bruner, Deborah W.; Minasian, Lori M.; Basch, Ethan

    2016-01-01

    Importance Symptomatic adverse events (AEs) in cancer trials are currently reported by clinicians using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE). To integrate the patient perspective, the NCI developed a patient-reported outcomes version of the CTCAE (PRO-CTCAE) to capture symptomatic AEs directly from patients. Objective To assess the construct validity, test-retest reliability, and responsiveness of PRO-CTCAE items. Design Participants completed PRO-CTCAE items on tablet computers in clinic waiting rooms at two visits 1-6 weeks apart. A subset completed PRO-CTCAE items during an additional visit one business day after the first visit. Setting Nine U.S. cancer centers and community oncology practices. Participants 975 adult cancer patients undergoing outpatient chemotherapy and/or radiation enrolled between January 2011 and February 2012. Eligibility required participants to read English and be without clinically significant cognitive impairment. Main Outcome(s) and Measure(s) Primary comparators were clinician-reported Eastern Cooperative Oncology Group Performance Status (ECOG PS) and the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30). Results 940/975 (96%) and 852/940 (91%) participants completed PRO-CTCAE items at each visit. 938/940 (99.8%) participants (53% female, median age 59, 32% high school education or less, 17% ECOG PS 2-4) reported having at least one symptom. All PRO-CTCAE items had at least one correlation in the expected direction with a QLQ-C30 scale (111/124 P<.05). Stronger correlations were seen between PRO-CTCAE items and conceptually-related QLQ-C30 domains. Scores for 94/124 PRO-CTCAE items were higher in the ECOG PS 2-4 versus 0-1 group (58/124 P<.05). Overall, 119/124 items met at least one construct validity criterion. Test-retest reliability was acceptable for 36/49 pre-specified items (median intra-class correlation coefficient

  1. Clinical and Patient-reported Outcomes in Patients with Psoriatic Arthritis (PsA) by Body Surface Area Affected by Psoriasis: Results from the Corrona PsA/Spondyloarthritis Registry.

    Science.gov (United States)

    Mease, Philip J; Karki, Chitra; Palmer, Jacqueline B; Etzel, Carol J; Kavanaugh, Arthur; Ritchlin, Christopher T; Malley, Wendi; Herrera, Vivian; Tran, Melody; Greenberg, Jeffrey D

    2017-08-01

    Psoriatic arthritis (PsA) is commonly comorbid with psoriasis; the extent of skin lesions is a major contributor to psoriatic disease severity/burden. We evaluated whether extent of skin involvement with psoriasis [body surface area (BSA) > 3% vs ≤ 3%] affects overall clinical and patient-reported outcomes (PRO) in patients with PsA. Using the Corrona PsA/Spondyloarthritis Registry, patient characteristics, disease activity, and PRO at registry enrollment were assessed for patients with PsA aged ≥ 18 years with BSA > 3% versus ≤ 3%. Regression models were used to evaluate associations of BSA level with outcome [modified minimal disease activity (MDA), Health Assessment Questionnaire (HAQ) score, patient-reported pain and fatigue, and the Work Productivity and Activity Impairment questionnaire score]. Adjustments were made for age, sex, race, body mass index, disease duration, and history of biologics, disease-modifying antirheumatic drug, and prednisone use. This analysis included 1240 patients with PsA with known BSA level (n = 451, BSA > 3%; n = 789, BSA ≤ 3%). After adjusting for potential confounding variables, patients with BSA > 3% versus ≤ 3% had greater patient-reported pain and fatigue and higher HAQ scores (p = 2.33 × 10 -8 , p = 0.002, and p = 1.21 × 10 -7 , respectively), were 1.7× more likely not to be in modified MDA (95% CI 1.21-2.41, p = 0.002), and were 2.1× more likely to have overall work impairment (1.37-3.21, p = 0.0001). These Corrona Registry data show that substantial skin involvement (BSA > 3%) is associated with greater PsA disease burden, underscoring the importance of assessing and effectively managing psoriasis in patients with PsA because this may be a contributing factor in PsA severity.

  2. Montreal Accord on Patient-Reported Outcomes (PROs) use series - Paper 6: creating national initiatives to support development and use-the PROMIS example.

    Science.gov (United States)

    Bartlett, Susan J; Witter, James; Cella, David; Ahmed, Sara

    2017-09-01

    Patient-reported outcome (PRO) data are beneficial to a range of stakeholders including patients, clinicians, researchers, national funding and regulatory agencies, health system administrators, and policymakers. Because stakeholders represent diverse groups and needs, it is challenging to reach consensus on how to advance PRO development and harmonize data across settings to enable use for multiple secondary purposes. Collaborative national networks can facilitate the sharing of expertise, resources, and necessary infrastructure; create development, use, and reporting standards; optimize formats to efficiently store and transfer data; and disseminate tools and information for widespread uptake. In the United States, the National Institutes of Health's Patient-Reported Outcomes Measurement Information System offers an example of how collaborators can work across distances to form essential partnerships, create a common vision, and leverage technology to accelerate the development and testing of universal PROs that are broadly applicable across health conditions and settings. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. Cross-cultural validity of the thyroid-specific quality-of-life patient-reported outcome measure, ThyPRO

    DEFF Research Database (Denmark)

    Watt, Torquil; Barbesino, Giuseppe; Bjørner, Jakob

    2015-01-01

    BACKGROUND AND PURPOSE: Thyroid diseases are common and often affect quality of life (QoL). No cross-culturally validated patient-reported outcome measuring thyroid-related QoL is available. The purpose of the present study was to test the cross-cultural validity of the newly developed thyroid......-related patient-reported outcome ThyPRO, using tests for differential item functioning (DIF) according to language version. METHODS: The ThyPRO consists of 85 items summarized in 13 multi-item scales and one single item. Scales cover physical and mental symptoms, well-being and function as well as social...... scale scores, most of which could be explained by sample differences not controlled for. CONCLUSION: The ThyPRO has good cross-cultural validity with only minor cross-cultural invariance and is recommended for use in international multicenter studies....

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

    OpenAIRE

    Jones, GL

    2017-01-01

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

  5. Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the Design and Operation of Multi-center Clinical Trials: a Qualitative Research Study

    OpenAIRE

    Eisenstein, Eric L.; Diener, Lawrence W.; Nahm, Meredith; Weinfurt, Kevin P.

    2010-01-01

    New technologies may be required to integrate the National Institutes of Health’s Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators ...

  6. Rasch-family models are more valuable than score-based approaches for analysing longitudinal patient-reported outcomes with missing data.

    Science.gov (United States)

    de Bock, Élodie; Hardouin, Jean-Benoit; Blanchin, Myriam; Le Neel, Tanguy; Kubis, Gildas; Bonnaud-Antignac, Angélique; Dantan, Étienne; Sébille, Véronique

    2016-10-01

    The objective was to compare classical test theory and Rasch-family models derived from item response theory for the analysis of longitudinal patient-reported outcomes data with possibly informative intermittent missing items. A simulation study was performed in order to assess and compare the performance of classical test theory and Rasch model in terms of bias, control of the type I error and power of the test of time effect. The type I error was controlled for classical test theory and Rasch model whether data were complete or some items were missing. Both methods were unbiased and displayed similar power with complete data. When items were missing, Rasch model remained unbiased and displayed higher power than classical test theory. Rasch model performed better than the classical test theory approach regarding the analysis of longitudinal patient-reported outcomes with possibly informative intermittent missing items mainly for power. This study highlights the interest of Rasch-based models in clinical research and epidemiology for the analysis of incomplete patient-reported outcomes data. © The Author(s) 2013.

  7. Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards.

    Science.gov (United States)

    Bottomley, Andrew; Pe, Madeline; Sloan, Jeff; Basch, Ethan; Bonnetain, Franck; Calvert, Melanie; Campbell, Alicyn; Cleeland, Charles; Cocks, Kim; Collette, Laurence; Dueck, Amylou C; Devlin, Nancy; Flechtner, Hans-Henning; Gotay, Carolyn; Greimel, Eva; Griebsch, Ingolf; Groenvold, Mogens; Hamel, Jean-Francois; King, Madeleine; Kluetz, Paul G; Koller, Michael; Malone, Daniel C; Martinelli, Francesca; Mitchell, Sandra A; Moinpour, Carol M; Musoro, Jammbe; O'Connor, Daniel; Oliver, Kathy; Piault-Louis, Elisabeth; Piccart, Martine; Pimentel, Francisco L; Quinten, Chantal; Reijneveld, Jaap C; Schürmann, Christoph; Smith, Ashley Wilder; Soltys, Katherine M; Taphoorn, Martin J B; Velikova, Galina; Coens, Corneel

    2016-11-01

    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 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 data in cancer randomised trials. This Personal View discusses the reasons why this project was initiated, the rationale for the planned work, and the expected benefits to cancer research, patient and provider decision making, care delivery, and policy making. Copyright © 2016 Elsevier Ltd. All rights reserved.

  8. Association of obesity with patient-reported outcomes in patients with axial spondyloarthritis: a cross-sectional study in an urban Asian population.

    Science.gov (United States)

    Lee, Yi Xuan; Kwan, Yu Heng; Png, Wan Yu; Lim, Ka Keat; Tan, Chuen Seng; Lui, Nai Lee; Chew, Eng Hui; Thumboo, Julian; Østbye, Truls; Fong, Warren

    2017-10-01

    To determine if obesity is associated with poorer patient-reported outcomes (PROs) in patients with axial spondyloarthritis (axSpA), we conducted a cross-sectional study using data of the PRESPOND registry from a tertiary referral center in Singapore between 2011 and 2015. Demographics, clinical, and PRO variables were collected. Patients were divided into three categories: normal (BMI < 23 kg/m 2 ), overweight (23 kg/m 2  ≤ BMI < 27.5 kg/m 2 ) and obese (BMI ≥ 27.5 kg/m 2 ), using Asian BMI classification. The dependent variables are Pain score, Bath Ankylosing Spondylitis Patient Global Score (BAS-G), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Health Assessment Questionnaire (HAQ), and Medical Outcomes Study Short Form 36 version 2 (SF-36). Multivariate regression analyses were performed with these dependent variables and obesity categories, adjusting for confounders. Among 194 patients with axSpA, 32% are overweight while 22% are obese. We found that obese patients had significant poorer pain (β: 11.87, 95%CI 2.13, 21.60) and BAS-G scores (β: 10.18, 95%CI 1.59, 18.76) when compared to normal BMI patients. However, obesity was not associated with BASDAI (β 0.50, 95%CI -0.22, 1.22), BASFI (β 0.08, 95%CI -0.66, 0.81), HAQ (β -0.07, 95%CI -0.21, 0.06), physical component summary (β -0.02, 95%CI -4.47, 4.44), and mental component summary (β -2.85, 95%CI -7.57, 1.88) of SF-36. Obesity was associated with pain score and BAS-G but not with BASDAI, BASFI, HAQ, and SF-36. Further study is needed to examine the causal relationship between obesity and poorer PROs.

  9. Effects of tofacitinib monotherapy on patient-reported outcomes in a randomized phase 3 study of patients with active rheumatoid arthritis and inadequate responses to DMARDs.

    Science.gov (United States)

    Strand, Vibeke; Kremer, Joel; Wallenstein, Gene; Kanik, Keith S; Connell, Carol; Gruben, David; Zwillich, Samuel H; Fleischmann, Roy

    2015-11-04

    Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. In this 6-month, phase 3, randomized, placebo-controlled trial, 611 patients with inadequate response to disease-modifying anti-rheumatic drugs (DMARD-IR) were randomized 4:4:1:1 to receive: tofacitinib 5 mg BID or tofacitinib 10 mg BID for the duration of the study, or placebo for 3 months followed by tofacitinib 5 mg BID or tofacitinib 10 mg BID. Patient-reported outcomes (PROs) included: Patient Global Assessment of Disease Activity (PtGA); Patient Assessment of Pain (Pain); Health Assessment Questionnaire-Disability Index (HAQ-DI); Medical Outcomes Survey (MOS) Short Form-36 (SF-36); Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F); and MOS Sleep Scale. Time-to-event data (PtGA and Pain) were collected using an interactive voice response system daily diary (baseline through day 14). At month 3, tofacitinib 5 and 10 mg BID demonstrated statistically significant improvements versus placebo in PtGA (both p tofacitinib treatment were rapid in onset and significant improvements were reported at week 2 for PtGA, Pain and HAQ-DI, and differentiation from baseline was seen as early as 3 days after treatment initiation for interactive voice response system (IVRS) PtGA and IVRS Pain. The numbers needed to treat for patients to report changes greater than or equal to the minimum clinically important difference in PtGA, Pain, HAQ-DI, SF-36 Physical Component Summary score and FACIT-F ranged between 4.0-6.1 (5 mg BID) and 3.2-5.0 (10 mg BID). Tofacitinib monotherapy in DMARD-IR patients resulted in statistically significant and clinically meaningful improvements in multiple PROs versus placebo at month 3, with sustained improvements over 6 months. Clinicaltrials.gov registration NCT00814307 , registered 22 December 2008.

  10. The effect of posterior and lateral approach on patient-reported outcome measures and physical function in patients with osteoarthritis, undergoing total hip replacement

    DEFF Research Database (Denmark)

    Rosenlund, Signe; Broeng, Leif; Jensen, Carsten

    2014-01-01

    BACKGROUND: Total hip replacement provides pain relief and improves physical function and quality of life in patients with end-stage hip osteoarthritis. The incidence of hip replacement operations is expected to increase due to the growing elderly population. Overall, the posterior approach...... Outcome Score, subscale of "Physical function Short form" (HOOS-PS) Secondary outcome measures include two other subscales of HOOS ("Pain" and "Hip related Quality of Life"), physical activity level (UCLA activity score), limping (HHS) and general health status (EQ-5D-3L). Explorative outcomes include...... physical function and pain; however, this has not been investigated in a randomised controlled trial with a twelve-month follow-up. We hypothesized that the lateral approach has an inferior outcome in patient-reported outcome compared with the posterior approach after one year. METHODS/DESIGN: The trial...

  11. Patient-reported outcomes from EMILIA, a randomized phase 3 study of trastuzumab emtansine (T-DM1) versus capecitabine and lapatinib in human epidermal growth factor receptor 2-positive locally advanced or metastatic breast cancer.

    Science.gov (United States)

    Welslau, Manfred; Diéras, Veronique; Sohn, Joo-Hyuk; Hurvitz, Sara A; Lalla, Deepa; Fang, Liang; Althaus, Betsy; Guardino, Ellie; Miles, David

    2014-03-01

    This report describes the results of an analysis of patient-reported outcomes from EMILIA (TDM4370g/BO21977), a randomized phase 3 study of the antibody-drug conjugate trastuzumab emtansine (T-DM1) versus capecitabine and lapatinib in human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer. A secondary endpoint of the EMILIA study was time to symptom worsening (time from randomization to the first documentation of a ≥ 5-point decrease from baseline) as measured by the Trial Outcome Index Physical/Functional/Breast (TOI-PFB) subset of the Functional Assessment of Cancer Therapy-Breast questionnaire. Predefined exploratory patient-reported outcome endpoints included proportion of patients with a clinically significant improvement in symptoms (per TOI-PFB) and proportion of patients with diarrhea symptoms (per Diarrhea Assessment Scale). In the T-DM1 arm, 450 of 495 patients had a baseline and ≥ 1 postbaseline TOI-PFB score versus 445 of 496 patients in the capecitabine-plus-lapatinib arm. Time to symptom worsening was delayed in the T-DM1 arm versus the capecitabine-plus-lapatinib arm (7.1 months versus 4.6 months, respectively; hazard ratio = 0.796; P = .0121). In the T-DM1 arm, 55.3% of patients developed clinically significant improvement in symptoms from baseline versus 49.4% in the capecitabine-plus-lapatinib arm (P = .0842). Although similar at baseline, the number of patients reporting diarrhea symptoms increased 1.5- to 2-fold during treatment with capecitabine and lapatinib but remained near baseline levels in the T-DM1 arm. Together with the EMILIA primary data, these results support the concept that T-DM1 has greater efficacy and tolerability than capecitabine plus lapatinib, which may translate into improvements in health-related quality of life. © 2013 American Cancer Society.

  12. Systematic Review of Radiation Therapy Toxicity Reporting in Randomized Controlled Trials of Rectal Cancer: A Comparison of Patient-Reported Outcomes and Clinician Toxicity Reporting

    Energy Technology Data Exchange (ETDEWEB)

    Gilbert, Alexandra, E-mail: a.gilbert@leeds.ac.uk [Leeds Institute of Cancer & Pathology, University of Leeds, Leeds (United Kingdom); Ziegler, Lucy; Martland, Maisie [Leeds Institute of Cancer & Pathology, University of Leeds, Leeds (United Kingdom); Davidson, Susan [The Christie Hospital, Manchester (United Kingdom); Efficace, Fabio [Italian Group for Adult Hematologic Diseases, Rome (Italy); Sebag-Montefiore, David; Velikova, Galina [Leeds Institute of Cancer & Pathology, University of Leeds, Leeds (United Kingdom)

    2015-07-01

    The use of multimodal treatments for rectal cancer has improved cancer-related outcomes but makes monitoring toxicity challenging. Optimizing future radiation therapy regimens requires collection and publication of detailed toxicity data. This review evaluated the quality of toxicity information provided in randomized controlled trials (RCTs) of radiation therapy in rectal cancer and focused on the difference between clinician-reported and patient-reported toxicity. Medline, EMBASE, and the Cochrane Library were searched (January 1995-July 2013) for RCTs reporting late toxicity in patients treated with regimens including preoperative (chemo)radiation therapy. Data on toxicity measures and information on toxicity reported were extracted using Quantitative Analyses of Normal Tissue Effects in the Clinic recommendations. International Society for Quality of Life Research standards on patient-reported outcomes (PROs) were used to evaluate the quality of patient-reported toxicity. Twenty-one RCT publications met inclusion criteria out of 4144 articles screened. All PRO studies reported higher rates of toxicity symptoms than clinician-reported studies and reported on a wider range and milder symptoms. No clinician-reported study published data on sexual dysfunction. Of the clinician-reported studies, 55% grouped toxicity data related to an organ system together (eg “Bowel”), and 45% presented data only on more-severe (grade ≥3) toxicity. In comparison, all toxicity grades were reported in 79% of PRO publications, and all studies (100%) presented individual symptom toxicity data (eg bowel urgency). However, PRO reporting quality was variable. Only 43% of PRO studies presented baseline data, 28% did not use any psychometrically validated instruments, and only 29% of studies described statistical methods for managing missing data. Analysis of these trials highlights the lack of reporting standards for adverse events and reveals the differences between clinician and

  13. Radiofrequency energy delivery to the lower esophageal sphincter improves gastroesophageal reflux patient-reported outcomes in failed laparoscopic Nissen fundoplication cohort.

    Science.gov (United States)

    Noar, Mark; Squires, Patrick; Khan, Sulman

    2017-07-01

    Patients with uncontrollable gastroesophageal reflux disease (GERD) often undergo laparoscopic Nissen fundoplication (LNF); however, long-term there are often recurring symptoms and need for continuous medication use. Refractory LNF patients may receive radiofrequency energy delivery to the lower esophageal sphincter (Stretta) to ameliorate symptoms and medication requirements. The aim was to assess and compare long-term patient-reported outcomes of Stretta in refractory patients with and without previous LNF. We prospectively assessed and compared patient-reported outcomes in 18 refractory LNF patients and 81 standard refractory GERD patients that all underwent Stretta during 10-year follow-up. Patient-reported outcomes measured were GERD-HRQL (health-related quality of life), patient satisfaction scores, and daily medication requirements. The refractory LNF subset demonstrated median improvements in GERD-HRQL, satisfaction, and medication use at all follow-up time points ≥6 months to 10 years, which was significant from a baseline of both on- and off-medications (p  0.05) after Stretta. At 10 years, no significant differences were noted between refractory LNF and standard Stretta subsets regarding medication use (p = 0.088), patient satisfaction (p = 0.573), and GERD-HRQL (p = 0.075). Stretta procedures were completed without difficulty or significant intraoperative or long-term adverse events. Within a small cohort of refractory LNF patients, Stretta resulted in sustained improvement over 10 years with equivalent outcomes to non-LNF standard Stretta patients. Refractory LNF patients are a subpopulation that may be safely, effectively, and robustly aided by Stretta with fewer complications compared to redo of Nissen or chronic medication use.

  14. Prospective evaluation of patient-reported outcomes during treatment with deferasirox or deferoxamine for iron overload in patients with beta-thalassemia.

    Science.gov (United States)

    Cappellini, Maria Domenica; Bejaoui, Mohamed; Agaoglu, Leyla; Porter, John; Coates, Thomas; Jeng, Michael; Lai, Maria Eliana; Mangiagli, Antonio; Strauss, Gabriele; Girot, Robert; Watman, Nora; Ferster, Alina; Loggetto, Sandra; Abish, Sharon; Cario, Holger; Zoumbos, Nicolaos; Vichinsky, Elliott; Opitz, Herbert; Ressayre-Djaffer, Catherine; Abetz, Linda; Rofail, Diana; Baladi, Jean-Francois

    2007-05-01

    Iron chelation therapy (ICT) with deferoxamine (DFO), the current standard for the treatment of iron overload in patients with transfusion-dependent disorders such as beta-thalassemia, requires regular subcutaneous or intravenous infusions. This can lead to reduced quality of life and poor adherence, resulting in increased morbidity and mortality in iron-overloaded patients with beta-thalassemia. Deferasirox is an orally administered iron chelator that has been approved for use in the United States, Switzerland, and other countries. This analysis was conducted to compare patient-reported outcomes (PROs) during receipt of DFO infusions or once-daily oral therapy with deferasirox (ICL670). PROs were prospectively evaluated as part of a randomized, Phase III study comparing the efficacy and safety profile of DFO 20 to 60 mg/kg per day with those of deferasirox 5 to 30 mg/kg per day in patients (age > or =2 years) with beta-thalassemia who were receiving regular transfusions and had a liver iron concentration of > or =2 mg/g dry weight. PRO questionnaires were completed by patients or a parent or legal guardian at baseline, week 4, week 24, and end of study (EOS). Patients assessed their level of satisfaction with study treatment (very satisfied, satisfied, neutral, dissatisfied, or very dissatisfied) and rated its convenience (very convenient, convenient, neutral, inconvenient, or very inconvenient). Time lost from normal activities due to ICT in the previous 4 weeks was recorded using a single global assessment. At week 4, patients who had previous experience with DFO were asked to indicate their preference for treatment (ICT received before the study, ICT received during the study, no preference, or no response) and the reason for that preference. At EOS, all patients were asked if they would be willing to continue using the ICT they had received during the study. All study analyses were performed in all patients who received at least 1 dose of study medication

  15. Development and validation of the quality care questionnaire -palliative care (QCQ-PC): patient-reported assessment of quality of palliative care.

    Science.gov (United States)

    Yun, Young Ho; Kang, Eun Kyo; Lee, Jihye; Choo, Jiyeon; Ryu, Hyewon; Yun, Hye-Min; Kang, Jung Hun; Kim, Tae You; Sim, Jin-Ah; Kim, Yaeji

    2018-03-05

    In this study, we aimed to develop and validate an instrument that could be used by patients with cancer to evaluate their quality of palliative care. Development of the questionnaire followed the four-phase process: item generation and reduction, construction, pilot testing, and field testing. Based on the literature, we constructed a list of items for the quality of palliative care from 104 quality care issues divided into 14 subscales. We constructed scales of 43 items that only the cancer patients were asked to answer. Using relevance and feasibility criteria and pilot testing, we developed a 44-item questionnaire. To assess the sensitivity and validity of the questionnaire, we recruited 220 patients over 18 years of age from three Korean hospitals. Factor analysis of the data and fit statistics process resulted in the 4-factor, 32-item Quality Care Questionnaire-Palliative Care (QCQ-PC), which covers appropriate communication with health care professionals (ten items), discussing value of life and goals of care (nine items), support and counseling for needs of holistic care (seven items), and accessibility and sustainability of care (six items). All subscales and total scores showed a high internal consistency (Cronbach alpha range, 0.89 to 0.97). Multi-trait scaling analysis showed good convergent (0.568-0.995) and discriminant (0.472-0.869) validity. The correlation between the total and subscale scores of QCQ-PC and those of EORTC QLQ-C15-PAL, MQOL, SAT-SF, and DCS was obtained. This study demonstrates that the QCQ-PC can be adopted to assess the quality of care in patients with cancer.

  16. Patient-reported assessment of quality care at end of life: development and validation of Quality Care Questionnaire-End of Life (QCQ-EOL).

    Science.gov (United States)

    Yun, Young Ho; Kim, Soo-Hyun; Lee, Kyoung-Min; Park, Sang Min; Lee, Chang Geol; Choi, Youn Seon; Lee, Won Sup; Kim, Si-Young; Heo, Dae Seog

    2006-09-01

    Our goal was to validate an instrument with which terminally ill patients could evaluate the quality of care they receive at the end of life (EOL). Questionnaire development followed a four-phase process: item generation and reduction, construction, pilot testing, and field-testing. Using relevance and priority criteria and pilot testing, we developed a 16-item questionnaire. Factor analyses of data from 235 patients resulted in the Quality Care Questionnaire-End of Life (QCQ-EOL) covering dignity-conserving care, care by health care professionals, individualised care, and family relationships. All subscales and total scores showed high internal consistency (Cronbach alpha range, 0.73-0.89). The ability of total score and selective subscale scores clearly differentiated patients on the basis of clinical situation, sense of dignity, and general rating of care quality. Correlations of scores between patients and caregivers were substantial. The QCQ-EOL can be adopted to assess the quality of care received by terminally ill patients.

  17. Patient-reported outcomes in patients with overactive bladder treated with mirabegron and tolterodine in a prospective, double-blind, randomized, two-period crossover, multicenter study (PREFER).

    Science.gov (United States)

    Herschorn, Sender; Staskin, David; Tu, Le Mai; Fialkov, Jonathan; Walsh, Terry; Gooch, Katherine; Schermer, Carol R

    2018-04-19

    The PREFER study was an assessment of medication tolerability, treatment preference and symptom improvement during treatment with mirabegron (M) and tolterodine (T) extended release (ER) in patients with overactive bladder (OAB). In this analysis of PREFER, patient-reported outcomes (PROs) were assessed during treatment. PREFER was a two-period, 8-week crossover, double-blind, phase IV study (NCT02138747) of treatment-naïve adults with OAB ≥3 months randomized to 1 of 4 treatment sequences (M/T; T/M; M/M; T/T), separated by a 2-week washout. Tolterodine ER was dosed at 4 mg for 8 weeks and mirabegron was dosed at 25 mg for 4 weeks then increased to 50 mg for the next 4 weeks. At each visit, PROs related to treatment satisfaction, quality of life and symptom bother were assessed using the OAB Satisfaction (OAB-S; 3 independent scales/5 single-item overall assessments), OAB-q (total health-related QoL [HRQoL] and subscales [Sleep, Social, Coping, Concern] and Symptom Bother scale) and Patient Perception of Bladder Condition (PPBC) questionnaires. Responder rates were reported for OAB-q subscales based on a minimal important difference (MID; ≥ 10-point improvement) and OAB-S Medication Tolerability score ≥ 90. In total, 358 randomized patients received ≥1 dose of double-blind study medication and completed ≥1 post-baseline value (OAB-S scale, OAB-q, PPBC): M/T (n = 154), T/M (n = 144), M/M (n = 30) or T/T (n = 30). At end of treatment (EoT), mirabegron and tolterodine ER were associated with similar mean improvements in 7 of the 8 OAB-S scores investigated, OAB-q scales and PPBC. A higher percentage of patients achieved clinically relevant improvements (MID) in OAB-q scales and OAB-S Medication Tolerability score during treatment with mirabegron than tolterodine ER. On average, patients with OAB experienced improvements in treatment satisfaction, HRQoL and symptom bother that were of a similar magnitude during treatment with

  18. Patient reported outcome data following influenza A (H1N1p vaccination in the 2009–2010 season: web-based and telephone evaluation

    Directory of Open Access Journals (Sweden)

    Wade AG

    2011-10-01

    significantly lower risk. H1N1p vaccine was well tolerated by children under 5 years with side effects reported at a similar frequency to that found in the total population.Conclusions: Safety and tolerability data from influenza vaccine recipients including young children (via parents/carers can be effectively collected using an online questionnaire with a telephone option (PROBE. The influenza A (H1N1p vaccine was well tolerated, but was associated with more local short-term reactions than the seasonal influenza vaccine.Keywords: safety, influenza, vaccination, H1N1, patient reported outcomes, side effects

  19. The Gait Deviation Index Is Associated with Hip Muscle Strength and Patient-Reported Outcome in Patients with Severe Hip Osteoarthritis

    DEFF Research Database (Denmark)

    Rosenlund, Signe; Holsgaard-Larsen, Anders; Overgaard, Søren

    2016-01-01

    ) and with severe primary hip osteoarthritis underwent 3-dimensional gait analysis. Mean Gait Deviation Index, pain after walking and maximal isometric hip muscle strength (flexor, extensor, and abductor) were recorded. All patients completed the 'Physical Function Short-form of the Hip disability...... was to investigate associations between Gait Deviation Index as a measure of gait 'quality' and hip muscle strength and between Gait Deviation Index and patient-reported outcomes in patients with primary hip osteoarthritis. METHOD: Forty-seven patients (34 males), aged 61.1 ± 6.7 years, with BMI 27.3 ± 3.4 (kg/m2...... and Osteoarthritis Outcome Score (HOOS-Physical Function) and the Hip disability and Osteoarthritis Outcome Score subscales for pain (HOOS-Pain) and quality-of-life (HOOS-QOL). RESULTS: Mean Gait Deviation Index was positively associated with hip abduction strength (pstrength (p = 0...

  20. The Brief Symptom Inventory and the Outcome Questionnaire-45 in the Assessment of the Outcome Quality of Mental Health Interventions

    Directory of Open Access Journals (Sweden)

    Aureliano Crameri

    2016-01-01

    Full Text Available Self-report questionnaires are economical instruments for routine outcome assessment. In this study, the performance of the German version of the Outcome Questionnaire-45 (OQ-45 and the Brief Symptom Inventory (BSI was evaluated when applied in analysis of the outcome quality of psychiatric and psychotherapeutic interventions. Pre-post data from two inpatient samples (N=5711 and one outpatient sample (N=239 were analyzed. Critical differences (reliable change index and cut-off points between functional and dysfunctional populations were calculated using the Jacobson and Truax method of calculating clinical significance. Overall, the results indicated that the BSI was more accurate than the OQ-45 in correctly classifying patients as clinical subjects. Nonetheless, even with the BSI, about 25% of inpatients with schizophrenia attained a score at admission below the clinical cut-off. Both questionnaires exhibited the highest sensitivity to psychopathology with patients with personality disorders. When considering the differences in the prescores, both questionnaires showed the same sensitivity to change. The advantage of using these self-report measures is observed primarily in assessing outpatient psychotherapy outcome. In an inpatient setting two main problems—namely, the low response rate and the scarce sensitivity to psychopathology with severely ill patients—limit the usability of self-report questionnaires.

  1. A case-control study of the effectiveness of tissue plasminogen activator on 6 month patients--reported outcomes and health care utilization.

    Science.gov (United States)

    Lang, Catherine E; Bland, Marghuretta D; Cheng, Nuo; Corbetta, Maurizio; Lee, Jin-Moo

    2014-01-01

    We examined the benefit of tissue plasminogen activator (tPA), delivered as part of usual stroke management, on patient-reported outcomes and health care utilization. Using a case control design, patients who received tPA as part of usual stroke management were compared with patients who would have received tPA had they arrived to the hospital within the therapeutic time window. Data were collected from surveys 6 months after stroke using standardized patient-reported outcome measures and questions about health care utilization. Demographic and medical data were acquired from hospital records. Patients were matched on stroke severity, age, race, and gender. Matching was done with 1:2 ratio of tPA to controls. Results were compared between groups with 1-tailed tests because of a directionally specific hypothesis in favor of the tPA group. The tPA (n = 78) and control (n = 156) groups were matched across variables, except for stroke severity, which was better in the control group; subsequent analyses controlled for this mismatch. The tPA group reported better physical function, communication, cognitive ability, depressive symptomatology, and quality of life/participation compared with the control group. Fewer people in the tPA group reported skilled nursing facility stays, emergency department visits, and rehospitalizations after their stroke compared with controls. Reports of other postacute services were not different between groups. Although it is known that tPA reduces disability, this is the first study to demonstrate the effectiveness of tPA in improving meaningful, patient-reported outcomes. Thus, use of tPA provides a large benefit to the daily lives of people with ischemic stroke. Copyright © 2014 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  2. A content analysis of peripheral arterial disease patient-reported outcome measures using the International Classification of Functioning, Disability and Health.

    Science.gov (United States)

    Osborne, Candice Lee; Kauvar, David Seth

    2017-10-17

    The purpose of this study was to link, classify and describe the content of peripheral arterial disease (PAD)-specific patient-reported outcome measures using the International Classification of Functioning. The results were then analyzed to determine if these assessments provide clinicians and researchers with a comprehensive understanding of the lived experience of patients with PAD. Each meaningful concept in identified PAD assessments was linked to the International Classification of Functioning, Disability and Health to determine included and excluded content areas. An overall perspective was assigned to each assessment item. Inter-rater reliability was established using a kappa statistic. The body functions component is most frequently addressed overall followed by the activities and participation component. International Classification of Functioning chapter and category distribution vary greatly between assessments and no assessment comprehensively examines community participation and relationships. The majority of the assessment items are of the health status-disability and quality of life perspectives. The results of this study suggest the need for the development of a comprehensive PAD assessment that includes a more even distribution of International Classification of Functioning topics and subtopics. A more comprehensive assessment would better capture the lived experience of this patient population. Implications for Rehabilitation A better understanding of the data collected using the current peripheral arterial disease-specific patient-reported outcome measures may contribute to the development of more comprehensive assessment tools that will ultimately lead to improved patient care. This study contributes to the preliminary foundation for the development of a peripheral arterial disease International Classification of Functioning, Disability and Health Core Set. Clinicians and researchers interested in using peripheral arterial disease

  3. Patient reported outcome measures in women undergoing surgery for urinary incontinence and pelvic organ prolapse in Denmark, 2006-2011

    DEFF Research Database (Denmark)

    Sørensen, Rikke Guldberg; Kesmodel, Ulrik Schiøler; Hansen, Jesper Kjær

    2012-01-01

    surgery for urinary incontinence (UI) or pelvic organ prolapse (POP) from 2006 to 2011. Using frequency of symptoms and a visual analogue scale (VAS) both pre- and postoperatively, their severity of symptoms and quality of life were measured by questionnaires. RESULTS: During the study period, 20...

  4. Patient-Reported Outcomes for Quality of Life Assessment in Atrial Fibrillation: A Systematic Review of Measurement Properties.

    Science.gov (United States)

    Kotecha, Dipak; Ahmed, Amar; Calvert, Melanie; Lencioni, Mauro; Terwee, Caroline B; Lane, Deirdre A

    2016-01-01

    Atrial fibrillation is a large and growing burden across all types of healthcare. Both incidence and prevalence are expected to double in the next 20 years, with huge impact on hospital admissions, costs and patient quality of life. Patient wellbeing determines the management strategy for atrial fibrillation, including the use of rhythm control therapy and the clinical success of heart rate control. Hence, evaluation of quality of life is an emerging and important part of the assessment of patients with atrial fibrillation. Although a number of questionnaires to assess quality of life in atrial fibrillation are available, a comprehensive overview of their measurement properties is lacking. We performed a systematic review of the measurement properties of atrial fibrillation-specific health-related quality of life questionnaires. Methodological quality was assessed using the Consensus based Standards for selection of health Measurement Instruments (COSMIN) checklist, with measurement properties rated for quality against optimal criteria and levels of evidence. We screened 2,216 articles, of which eight articles describing five questionnaires were eligible for inclusion: Atrial Fibrillation 6 (AF6), Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT), Atrial Fibrillation Quality of Life Questionnaire (AFQLQ), Atrial Fibrillation Quality of Life (AFQoL), and Quality of Life in Atrial Fibrillation (QLAF). Good reliability (internal consistency and test-retest reliability) was demonstrated for AF6, AFEQT, AFQLQ and AFQoL. Content, construct and criterion validity were positively rated only in AFEQT. Responsiveness was positively rated only in AFEQT, but with limited evidence. Overall, AFEQT showed strong positive evidence for 2 of 9 measurement properties, compared to one for AFQoL and none for the remaining questionnaires. Given the low ratings for many measurement properties, no single questionnaire can be recommended, although AFEQT performed strongest. Further

  5. Presence of pain on three or more days of the week is associated with worse patient reported outcomes in adults with sickle cell disease

    Directory of Open Access Journals (Sweden)

    Bakshi N

    2018-02-01

    Full Text Available Nitya Bakshi,1,2 Diana Ross,1 Lakshmanan Krishnamurti1,2 1Division of Pediatric Hematology-Oncology-BMT, Department of Pediatrics, Emory University, Atlanta, GA, USA; 2Aflac Cancer and Blood Disorders Center, Children’s Healthcare of Atlanta, Atlanta, GA, USA Abstract: While acute episodic pain is the hallmark of sickle cell disease (SCD, transition to chronic pain is a major cause of morbidity and impaired quality of life. One of the core diagnostic criteria used by Analgesic, Anesthetic, and Addiction Clinical Trial Translations Innovations Opportunities and Networks-American Pain Society Pain Taxonomy (AAPT to define chronic SCD pain is the presence of pain on a “majority of days” in the past 6 months in one or more locations. The frequency characteristic of “majority of days” is adapted from the criteria of 15 days or more per month, used to define chronic migraine, but there are inadequate data to support this cutoff in SCD. Using an existing dataset of adults with SCD who completed patient-reported outcomes of pain interference, physical functioning, anxiety, depression, and fatigue using the National Institutes of Health (NIH patient-reported outcomes measures information system (PROMIS short-form instruments, we examined the association of the presence of pain on 3 or more days per week with patient-reported outcomes of functioning. In unadjusted analyses, presence of pain on 3 or more days a week was associated with higher median PROMIS scores of pain interference, anxiety, and depression. Median PROMIS scores of fatigue and physical function were worse in women compared with men in unadjusted analyses. We did not find any difference in median PROMIS pain scores between adults aged ≤35 years compared with those aged ≥35 years. In linear regression models, after adjustment for age and sex, the presence of pain on 3 or more days a week was found to be associated with worse pain interference and anxiety. These data support

  6. Multinational Prospective Study of Patient-Reported Outcomes After Prostate Radiation Therapy: Detailed Assessment of Rectal Bleeding

    International Nuclear Information System (INIS)

    Lee, Jae Y.; Daignault-Newton, Stephanie; Heath, Gerard; Scarlett, Sarah; Sanda, Martin G.; Chang, Peter; Regan, Meredith M.; Michalski, Jeff M.; Sandler, Howard M.; Feng, Felix Y.; Kuban, Deborah A.; Zietman, Anthony L.; Ciezki, Jay P.; Kaplan, Irving D.; Crociani, Catrina; McLaughlin, William P.; Mantz, Constantine A.; Finkelstein, Steven E.; Suy, Simeng; Collins, Sean P.

    2016-01-01

    Purpose: The new short Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) patient-reported health-related quality of life (HRQOL) tool has removed the rectal bleeding question from the previous much longer version, EPIC-26. Herein, we assess the impact of losing the dedicated rectal bleeding question in 2 independent prospective multicenter cohorts. Methods and Materials: In a prospective multicenter test cohort (n=865), EPIC-26 patient-reported HRQOL data were collected for 2 years after treatment from patients treated with prostate radiation therapy from 2003 to 2011. A second prospective multicenter cohort (n=442) was used for independent validation. A repeated-effects model was used to predict the change from baseline in bowel summary scores from longer EPIC instruments using the change in EPIC-CP bowel summary scores with and without rectal bleeding scores. Results: Two years after radiation therapy, 91% of patients were free of bleeding, and only 2.6% reported bothersome bleeding problems. Correlations between EPIC-26 and EPIC-CP bowel scores were very high (r"2=0.90-0.96) and were statistically improved with the addition of rectal bleeding information (r"2=0.