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Sample records for patient-reported outcomes measurement

  1. Choosing a patient-reported outcome measure.

    PubMed

    McClimans, Leah M; Browne, John

    2011-02-01

    There has been much philosophical interest regarding the 'hierarchy of evidence' used to determine which study designs are of most value for reporting on questions of effectiveness, prognosis, and so on. There has been much less philosophical interest in the choice of outcome measures with which the results of, say, an RCT or a cohort study are presented. In this paper, we examine the FDA's recently published guidelines for assessing the psychometric adequacy of patient-reported outcome measures. We focus on their recommendations for demonstrating content validity and also for how researchers should weigh up the sum of psychometric evidence when choosing these measures. We argue that questions regarding judgment and understanding meaning of these measures should play a more central role in determining their adequacy.

  2. Patient-Reported Outcome Measures in Systemic Sclerosis (Scleroderma).

    PubMed

    Pellar, Russell E; Tingey, Theresa M; Pope, Janet Elizabeth

    2016-05-01

    Scleroderma (systemic sclerosis) is a rare autoimmune connective tissue disease that can damage multiple organs and reduce quality of life. Patient-reported outcome measures capture the patient's perspective. Some measures are specific to systemic sclerosis and others are general. Patient-reported outcomes in systemic sclerosis are important to aid in understanding the impact of systemic sclerosis on patients. PMID:27133491

  3. Advances in Patient-Reported Outcomes: The NIH PROMIS® Measures

    PubMed Central

    Broderick, Joan E.; DeWitt, Esi Morgan; Rothrock, Nan; Crane, Paul K.; Forrest, Christopher B.

    2013-01-01

    Patient-reported outcomes (PRO) are questionnaire measures of patients’ symptoms, functioning, and health-related quality of life. They are designed to provide important clinical information that generally cannot be captured with objective medical testing. In 2004, the National Institutes of Health launched a research initiative to improve the clinical research enterprise by developing state-of-the-art PROs. The NIH Patient-Reported Outcomes Measurement System (PROMIS) and Assessment Center are the products of that initiative. Adult, pediatric, and parent-proxy item banks have been developed by using contemporary psychometric methods, yielding rapid, accurate measurements. PROMIS currently provides tools for assessing physical, mental, and social health using short-form and computer-adaptive testing methods. The PROMIS tools are being adopted for use in clinical trials and translational research. They are also being introduced in clinical medicine to assess a broad range of disease outcomes. Recent legislative developments in the United States support greater efforts to include patients’ reports of health experience in order to evaluate treatment outcomes, engage in shared decision-making, and prioritize the focus of treatment. PROs have garnered increased attention by the Food and Drug Administration (FDA) for evaluating drugs and medical devices. Recent calls for comparative effectiveness research favor inclusion of PROs. PROs could also potentially improve quality of care and disease outcomes, provide patient-centered assessment for comparative effectiveness research, and enable a common metric for tracking outcomes across providers and medical systems. PMID:25848562

  4. Patient-reported outcome measures after total knee arthroplasty

    PubMed Central

    Ramkumar, P. N.; Harris, J. D.; Noble, P. C.

    2015-01-01

    Objectives A lack of connection between surgeons and patients in evaluating the outcome of total knee arthroplasty (TKA) has led to the search for the ideal patient-reported outcome measure (PROM) to evaluate these procedures. We hypothesised that the desired psychometric properties of the ideal outcome tool have not been uniformly addressed in studies describing TKA PROMS. Methods A systematic review was conducted investigating one or more facets of patient-reported scores for measuring primary TKA outcome. Studies were analysed by study design, subject demographics, surgical technique, and follow-up adequacy, with the ‘gold standard’ of psychometric properties being systematic development, validity, reliability, and responsiveness. Results A total of 38 articles reported outcomes from 47 different PROMS to 85 541 subjects at 26.3 months (standard deviation 30.8) post-operatively. Of the 38, eight developed new scores, 20 evaluated existing scores, and ten were cross-cultural adaptation of existing scores. Only six of 38 surveyed studies acknowledged all ‘gold standard’ psychometric properties. The most commonly studied PROMS were the Oxford Knee Score, New Knee Society Score, Osteoarthritis Outcome Score, and Western Ontario and McMaster Universities Osteoarthritis Index. Conclusions A single, validated, reliable, and responsive PROM addressing TKA patients’ priorities has not yet been identified. Moreover, a clear definition of a successful procedure remains elusive. Cite this article: Bone Joint Res 2015;4:120–127 PMID:26220999

  5. Patient-reported outcome measures in inflammatory bowel disease

    PubMed Central

    El-Matary, Wael

    2014-01-01

    Patient-reported outcome measures (PROMs) are increasingly used in both research and clinical health settings. With the recent development of United States Food and Drug Administration guidance on PROMs, more attention is being devoted to their role and importance in health care. Several methodological challenges in the development, validation and implementation of PROMs must be resolved to ensure their appropriate utilization and interpretation. The present review discusses recent developments and updates in PROMs, with specific focus on the area of inflammatory bowel disease. PMID:25390615

  6. Patient-reported outcome measures in arthroplasty registries

    PubMed Central

    Eresian Chenok, Kate; Bohm, Eric; Lübbeke, Anne; Denissen, Geke; Dunn, Jennifer; Lyman, Stephen; Franklin, Patricia; Dunbar, Michael; Overgaard, Søren; Garellick, Göran; Dawson, Jill

    2016-01-01

    The International Society of Arthroplasty Registries (ISAR) Steering Committee established the Patient-Reported Outcome Measures (PROMs) Working Group to convene, evaluate, and advise on best practices in the selection, administration, and interpretation of PROMs and to support the adoption and use 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. The establishment of a PROM instrument requires the fulfillment of methodological standards and rigorous testing to ensure that it is valid, reliable, responsive, and acceptable to the intended population. A survey of the 41 ISAR member registries showed that 8 registries administered a PROMs program that covered 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 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 and McMaster Universities Arthritis Index (WOMAC), and the University of California at Los Angeles Activity Score (UCLA). PMID:27168175

  7. Patient-reported outcome measures in arthroplasty registries

    PubMed Central

    Bohm, Eric; Franklin, Patricia; Lyman, Stephen; Denissen, Geke; Dawson, Jill; Dunn, Jennifer; Eresian Chenok, Kate; Dunbar, Michael; Overgaard, Søren; Garellick, Göran; Lübbeke, Anne

    2016-01-01

    Abstract — 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 question (“During the past 4 weeks, how would you describe the pain you usually have in your [right/left] [hip/knee]?”; response: none, very mild, mild, moderate, or severe) and a single-item satisfaction outcome (“How satisfied are you with your [right/left] [hip/knee] replacement?”; response: very unsatisfied, dissatisfied, neutral, satisfied, or very satisfied). Survey logistics include patient instructions, paper- and electronic-based data collection, reminders for follow-up, centralized as opposed to hospital-based follow-up, sample size, patient- or joint-specific evaluation, collection intervals, frequency of response, missing values, and factors in establishing a PROMs registry program. The Working Group recommends including age, sex, diagnosis at joint, general health status preoperatively, and joint pain and function score in case-mix adjustment models. Interpretation and statistical analysis 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 and 1 year after surgery, a threshold of 60% for acceptable frequency of response, documentation of non-responders, and documentation of incomplete or

  8. Measuring patient-reported outcomes in advanced gastric cancer

    PubMed Central

    Xu, Jianming; Evans, TR Jeffry; Coon, Cheryl; Copley-Merriman, Kati; Su, Yun

    2013-01-01

    Background Gastric cancer (GC), one of the most common cancers in the world, is often diagnosed at an advanced stage and associated with a poor prognosis. Quality of life and patient-reported outcomes (PROs) are important considerations when treating GC patients. The aim of this study was to identify existing PRO instruments that would be appropriate for use in GC trials. Methods Data were obtained from a systematic literature review and interviews with clinical experts. A literature search was conducted using OVID (EMBASE and MEDLINE) and yielded 1,008 abstracts; 92 assessed PROs in an advanced GC. Results Key symptoms and functional impacts identified through the literature and expert input included abdominal pain or pain at the site of distant metastases, dysphagia and other symptoms related to eating, and digestive symptoms. The liver and lungs were the most frequent locations of metastases, leading to dyspnea, abdominal fullness, and jaundice. Symptoms related to changes in bowel habits appeared to be more frequent and pronounced in Asian patients, possibly due to the higher prevalence of GC in the body of the stomach in this population. The five most commonly used PRO instruments were identified, but their validity in advanced-stage GC patients remains unclear. Conclusions The symptoms and functional impacts identified here should be confirmed with robust input from advanced-stage GC patients. Optimal measurement of PROs in GC should account for patient burden and possible differences between Asian and non-Asian patients. PMID:24062809

  9. An introduction to patient-reported outcome measures in ophthalmic research

    PubMed Central

    Denniston, A K; Kyte, D; Calvert, M; Burr, J M

    2014-01-01

    Clinical outcomes, such as quantifying the extent of visual field loss by automated perimetry, are valued highly by health professionals, but such measures do not capture the impact of the condition on a patient's life. Patient-reported outcomes describe any report or measure of health reported by the patient, without external interpretation by a clinician or researcher. In this review, we discuss the value of the measures that capture this information (patient-reported outcome measures; PROMs), and why they are important to both the clinician and the researcher. We also consider issues around developing or selecting a PROM for ophthalmic research, the emerging challenges around conducting and reporting PROMs in clinical trials and highlight best practice for their use. Search terms for this review comprised: (1) (patient-reported outcomes OR patient-reported outcome measures) AND (2) randomised controlled trials AND (3) limited to ophthalmic conditions. These terms were expanded as follows: (((‘patients'(MeSH Terms) OR ‘patients'(All Fields) OR ‘patient'(All Fields)) AND (‘research report'(MeSH Terms) OR (‘research'(All Fields) AND ‘report'(All Fields)) OR ‘research report'(All Fields) OR ‘reported'(All Fields)) AND outcomes(All Fields)) OR ((‘patients'(MeSH Terms) OR ‘patients'(All Fields) OR ‘patient'(All Fields)) AND (‘research report'(MeSH Terms) OR (‘research'(All Fields) AND ‘report'(All Fields)) OR ‘research report'(All Fields) OR ‘reported'(All Fields) AND (‘outcome assessment (health care)'(MeSH Terms) OR (‘outcome'(All Fields) AND ‘assessment'(All Fields) AND ‘(health'(All Fields) AND ‘care)'(All Fields)) OR ‘outcome assessment (health care)'(All Fields) OR (‘outcome'(All Fields) AND ‘measures'(All Fields)) OR ‘outcome measures'(All Fields)))) AND (‘randomized controlled trial'(Publication Type) OR ‘randomized controlled trials as topic'(MeSH Terms) OR ‘randomised controlled trials'(All Fields) OR

  10. Longitudinal evaluation of patient-reported outcomes measurement information systems measures in pediatric chronic pain.

    PubMed

    Kashikar-Zuck, Susmita; Carle, Adam; Barnett, Kimberly; Goldschneider, Kenneth R; Sherry, David D; Mara, Constance A; Cunningham, Natoshia; Farrell, Jennifer; Tress, Jenna; DeWitt, Esi Morgan

    2016-02-01

    The Patient-Reported Outcomes Measurement Information System (PROMIS) initiative is a comprehensive strategy by the National Institutes of Health to support the development and validation of precise instruments to assess self-reported health domains across healthy and disease-specific populations. Much progress has been made in instrument development, but there remains a gap in the validation of PROMIS measures for pediatric chronic pain. The purpose of this study was to investigate the construct validity and responsiveness to change of 7 PROMIS domains for the assessment of children (ages: 8-18) with chronic pain--Pain Interference, Fatigue, Anxiety, Depression, Mobility, Upper Extremity Function, and Peer Relationships. The PROMIS measures were administered at the initial visit and 2 follow-up visits at an outpatient chronic pain clinic (CPC; N = 82) and at an intensive amplified musculoskeletal pain day-treatment program (N = 63). Aim 1 examined construct validity of PROMIS measures by comparing them with corresponding "legacy" measures administered as part of usual care in the CPC sample. Aim 2 examined sensitivity to change in both CPC and amplified musculoskeletal pain samples. Longitudinal growth models showed that PROMIS' Pain Interference, Anxiety, Depression, Mobility, Upper Extremity, and Peer Relationship measures and legacy instruments generally performed similarly with slightly steeper slopes of improvement in legacy measures. All 7 PROMIS domains showed responsiveness to change. Results offered initial support for the validity of PROMIS measures in pediatric chronic pain. Further validation with larger and more diverse pediatric pain samples and additional legacy measures would broaden the scope of use of PROMIS in clinical research.

  11. Systematic review of patient-reported outcome measures (PROMs) for assessing disease activity in rheumatoid arthritis

    PubMed Central

    de Jonge, Marieke J; Fransen, Jaap; Kievit, Wietske; van Riel, Piet LCM

    2016-01-01

    Patient assessment of disease activity in rheumatoid arthritis (RA) may be useful in clinical practice, offering a patient-friendly, location independent, and a time-efficient and cost-efficient means of monitoring the disease. The objective of this study was to identify patient-reported outcome measures (PROMs) to assess disease activity in RA and to evaluate the measurement properties of these measures. Systematic literature searches were performed in the PubMed and EMBASE databases to identify articles reporting on clinimetric development or evaluation of PROM-based instruments to monitor disease activity in patients with RA. 2 reviewers independently selected articles for review and assessed their methodological quality based on the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) recommendations. A total of 424 abstracts were retrieved for review. Of these abstracts, 56 were selected for reviewing the full article and 34 articles, presenting 17 different PROMs, were finally included. Identified were: Rheumatoid Arthritis Disease Activity Index (RADAI), RADAI-5, Patient-based Disease Activity Score (PDAS) I & II, Patient-derived Disease Activity Score with 28-joint counts (Pt-DAS28), Patient-derived Simplified Disease Activity Index (Pt-SDAI), Global Arthritis Score (GAS), Patient Activity Score (PAS) I & II, Routine Assessment of Patient Index Data (RAPID) 2–5, Patient Reported Outcome-index (PRO-index) continuous (C) & majority (M), Patient Reported Outcome CLinical ARthritis Activity (PRO-CLARA). The quality of reports varied from poor to good. Typically 5 out of 10 clinimetric domains were covered in the validations of the different instruments. The quality and extent of clinimetric validation varied among PROMs of RA disease activity. The Pt-DAS28, RADAI, RADAI-5 and RAPID 3 had the strongest and most extensive validation. The measurement properties least reported and in need of more evidence were: reliability

  12. Systematic review of patient-reported outcome measures (PROMs) for assessing disease activity in rheumatoid arthritis.

    PubMed

    Hendrikx, Jos; de Jonge, Marieke J; Fransen, Jaap; Kievit, Wietske; van Riel, Piet Lcm

    2016-01-01

    Patient assessment of disease activity in rheumatoid arthritis (RA) may be useful in clinical practice, offering a patient-friendly, location independent, and a time-efficient and cost-efficient means of monitoring the disease. The objective of this study was to identify patient-reported outcome measures (PROMs) to assess disease activity in RA and to evaluate the measurement properties of these measures. Systematic literature searches were performed in the PubMed and EMBASE databases to identify articles reporting on clinimetric development or evaluation of PROM-based instruments to monitor disease activity in patients with RA. 2 reviewers independently selected articles for review and assessed their methodological quality based on the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) recommendations. A total of 424 abstracts were retrieved for review. Of these abstracts, 56 were selected for reviewing the full article and 34 articles, presenting 17 different PROMs, were finally included. Identified were: Rheumatoid Arthritis Disease Activity Index (RADAI), RADAI-5, Patient-based Disease Activity Score (PDAS) I & II, Patient-derived Disease Activity Score with 28-joint counts (Pt-DAS28), Patient-derived Simplified Disease Activity Index (Pt-SDAI), Global Arthritis Score (GAS), Patient Activity Score (PAS) I & II, Routine Assessment of Patient Index Data (RAPID) 2-5, Patient Reported Outcome-index (PRO-index) continuous (C) & majority (M), Patient Reported Outcome CLinical ARthritis Activity (PRO-CLARA). The quality of reports varied from poor to good. Typically 5 out of 10 clinimetric domains were covered in the validations of the different instruments. The quality and extent of clinimetric validation varied among PROMs of RA disease activity. The Pt-DAS28, RADAI, RADAI-5 and RAPID 3 had the strongest and most extensive validation. The measurement properties least reported and in need of more evidence were: reliability

  13. Systematic review of patient-reported outcome measures (PROMs) for assessing disease activity in rheumatoid arthritis

    PubMed Central

    de Jonge, Marieke J; Fransen, Jaap; Kievit, Wietske; van Riel, Piet LCM

    2016-01-01

    Patient assessment of disease activity in rheumatoid arthritis (RA) may be useful in clinical practice, offering a patient-friendly, location independent, and a time-efficient and cost-efficient means of monitoring the disease. The objective of this study was to identify patient-reported outcome measures (PROMs) to assess disease activity in RA and to evaluate the measurement properties of these measures. Systematic literature searches were performed in the PubMed and EMBASE databases to identify articles reporting on clinimetric development or evaluation of PROM-based instruments to monitor disease activity in patients with RA. 2 reviewers independently selected articles for review and assessed their methodological quality based on the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) recommendations. A total of 424 abstracts were retrieved for review. Of these abstracts, 56 were selected for reviewing the full article and 34 articles, presenting 17 different PROMs, were finally included. Identified were: Rheumatoid Arthritis Disease Activity Index (RADAI), RADAI-5, Patient-based Disease Activity Score (PDAS) I & II, Patient-derived Disease Activity Score with 28-joint counts (Pt-DAS28), Patient-derived Simplified Disease Activity Index (Pt-SDAI), Global Arthritis Score (GAS), Patient Activity Score (PAS) I & II, Routine Assessment of Patient Index Data (RAPID) 2–5, Patient Reported Outcome-index (PRO-index) continuous (C) & majority (M), Patient Reported Outcome CLinical ARthritis Activity (PRO-CLARA). The quality of reports varied from poor to good. Typically 5 out of 10 clinimetric domains were covered in the validations of the different instruments. The quality and extent of clinimetric validation varied among PROMs of RA disease activity. The Pt-DAS28, RADAI, RADAI-5 and RAPID 3 had the strongest and most extensive validation. The measurement properties least reported and in need of more evidence were: reliability

  14. The Promise of Patient-Reported Outcomes Measurement Information System-Turning Theory into Reality: A Uniform Approach to Patient-Reported Outcomes Across Rheumatic Diseases.

    PubMed

    Witter, James P

    2016-05-01

    PROMIS, the Patient-Reported Outcomes Measurement Information System, is opening new possibilities to explore and learn how patient (or proxy) self-report of core symptoms and health-related quality of life can meaningfully advance clinical research and patient care. PROMIS leverages Item Response Theory to agnostically assess, across diseases and conditions or clinical settings, numerous universally applicable core "domains" of health (symptoms and functioning) from the patient perspective. Importantly, PROMIS is enabling the testing and adoption of computerized adaptive testing, which holds great potential to minimize patient burden while maximizing accuracy.

  15. Measuring and Predicting Patient Dissatisfaction after Anterior Urethroplasty Using Patient Reported Outcomes Measures

    PubMed Central

    Bertrand, Laura A.; Voelzke, Bryan B.; Elliott, Sean P.; Myers, Jeremy B.; Breyer, Benjamin N.; Vanni, Alex J.; McClung, Christopher D.; Tam, Christopher A.; Warren, Gareth J.; Erickson, Bradley A.

    2016-01-01

    Purpose Subjective measures of success after urethroplasty have become increasingly valuable in postoperative monitoring. We examined patient reported satisfaction following anterior urethroplasty using objective measures as a proxy for success. Materials and Methods Men 18 years old or older with urethral strictures undergoing urethroplasty were prospectively enrolled in a longitudinal, multi-institutional urethroplasty outcomes database. Preoperative and postoperative assessment included questionnaires to assess lower urinary tract symptoms, pain, satisfaction and sexual health. Analyses controlling for stricture recurrence (defined as the inability to traverse the reconstructed urethra with a flexible cystoscope) were performed to determine independent predictors of dissatisfaction. Results At a mean followup of 14 months we found a high 89.4% rate of overall postoperative satisfaction in 433 patients and a high 82.8% rate in those who would have chosen the operation again. Men with cystoscopic recurrence were more likely to report dissatisfaction (OR 4.96, 95% CI 2.07–11.90) and men reporting dissatisfaction had significantly worse uroflowmetry measures (each p <0.02). When controlling for recurrence, multivariate analysis revealed that urethra and bladder pain (OR 1.71, 95% CI 1.05–2.77 and OR 2.74, 95% CI 1.12–6.69, respectively), a postoperative decrease in sexual activity (OR 4.36, 95% CI 2.07–11.90) and persistent lower urinary tract symptoms (eg straining to urinate OR 3.23, 1.74-6.01) were independent predictors of dissatisfaction. Conclusions Overall satisfaction after anterior urethroplasty is high and traditional measures of surgical success strongly correlate with satisfaction. However, independently of the anatomical appearance of the reconstructed urethra, postoperative pain, sexual dysfunction and persistent lower urinary tract symptoms were predictors of patient dissatisfaction. PMID:26907509

  16. When to operate: online patient-reported outcome measures (PROMs) can help decide.

    PubMed

    Reeve, William John Edward; Williams, Daniel H

    2016-01-01

    We present a report on use of a web-based electronic patient-reported outcome measures (ePROMs) system to support decision-making for a patient with an osteoarthritic knee. After being placed on a waiting list for knee arthroplasty, the use of preoperative PROMs allowed the patient and surgical team to review ongoing disability, and, as a result, alter the management plan by deferring surgery. Ongoing clinical review and symptom management has been centred on ePROMs and has been tailored to the specific needs of the individual. PROMs data are increasingly becoming a necessary component of outcome measurement in many surgical areas. Often, these data are available to neither patient nor clinician in a way that prospectively allows meaningful management. This case highlights how ePROMs can directly influence patient care in real time. PMID:27090539

  17. Patient-reported outcomes measurement and management with innovative methodologies and technologies.

    PubMed

    Chang, Chih-Hung

    2007-01-01

    Successful integration of modern psychometrics and advanced informatics in patient-reported outcomes (PRO) measurement and management can potentially maximize the value of health outcomes research and optimize the delivery of quality patient care. Unlike the traditional labor-intensive paper-and-pencil data collection method, item response theory-based computerized adaptive testing methodologies coupled with novel technologies provide an integrated environment to collect, analyze and present ready-to-use PRO data for informed and shared decision-making. This article describes the needs, challenges and solutions for accurate, efficient and cost-effective PRO data acquisition and dissemination means in order to provide critical and timely PRO information necessary to actively support and enhance routine patient care in busy clinical settings.

  18. Development and Validation of the Keele Musculoskeletal Patient Reported Outcome Measure (MSK-PROM)

    PubMed Central

    2015-01-01

    Objective To develop and validate a patient report outcome measure (PROM) for clinical practice that can monitor health status of patients with a range of musculoskeletal (MSK) disorders. Methods Constructs for inclusion in the MSK-PROM were identified from a consensus process involving patients with musculoskeletal conditions, clinicians, purchasers of healthcare services, and primary care researchers. Psychometric properties of the brief tool, including face and construct validity, repeatability and responsiveness were assessed in a sample of patients with musculoskeletal pain consulting physiotherapy services in the United Kingdom (n=425). Results The consensus process identified 10 prioritised domains for monitoring musculoskeletal health status: pain intensity, quality of life, physical capacity, interference with social/leisure activities, emotional well-being, severity of most difficult thing, activities and roles, understanding independence, and overall impact. As the EuroQol (EQ-5D-5L) is a widely adopted PROMs tool and covers the first four domains listed, to reduce patient burden to a minimum the MSK-PROM was designed to capture the remaining six prioritised domains which are not measured by the EQ-5D-5L. The tool demonstrated excellent reliability, construct validity, responsiveness and acceptability to patients and clinicians for use in clinical practice. Conclusion We have validated a brief patient reported outcome measure (MSK-PROM) for use in clinical practice to measure musculoskeletal health status and monitor outcomes over time using domains that are meaningful to patients and sensitive to change. Further work will establish whether the MSK-PROM is useful in other musculoskeletal healthcare settings. PMID:25928807

  19. The measurement of patient-reported outcomes of refractive surgery: the refractive status and vision profile.

    PubMed Central

    Schein, O D

    2000-01-01

    PURPOSE: To develop a questionnaire, the Refractive Status and Vision Profile (RSVP), to assess health-related quality of life associated with refractive error and its correction. METHODS: The published literature on patient report of visual and overall function was reviewed, and the RSVP was self-administered by 550 participants with refractive error. Cross-sectional validation was performed using standard psychometric techniques. The responsiveness of the RSVP to surgical intervention was assessed prospectively in a subset of 176 patients. The principal outcomes measures were scores on the overall RSVP scale (S) and on 8 RSVP subscales (functioning, driving, concern, expectations, symptoms, glare, optical problems, problems with corrective lenses). RESULTS: The RSVP (S) and its subscales demonstrated very good internal consistency (Cronbach's alpha, 0.70-0.93). S and several subscale scores were independently associated with satisfaction with vision and were more correlated with satisfaction with vision than with either visual acuity or refractive error. Higher refractive error was associated with lower scores on S and on 5 subscales. In the prospective surgical cohort, 15% of patients had some worsening in their total RSVP score; however, substantial variation was seen in the individual subscales where worsening ranged from 7% (problems with corrective lenses) to 41% (driving). The effect size (measure of responsiveness) of the RSVP and most of its subscales was very high. Approximately 14% of patients had significant worsening in 3 or more subscales, and this outcome was found to be independently associated with being dissatisfied with vision following surgery (OR, 5.84; 95% CI, 1.88, 8.13). CONCLUSIONS: The RSVP has been validated as a questionnaire that measures patient-reported quality of life related to refractive error and its correction. It is responsive to surgical intervention and provides important information regarding patient outcomes not available

  20. A systematic review of patient-reported outcome instruments measuring sleep dysfunction in adults.

    PubMed

    Devine, Emily Beth; Hakim, Zafar; Green, Jesse

    2005-01-01

    Sleep dysfunction can manifest in several ways, ranging from insomnia to somnolence, and from disrupted sleep to lack of restful sleep. Measuring sleep dysfunction is an area of active research and there exist a number of patient-reported outcome instruments that measure various aspects of sleep dysfunction. However, these instruments have not been evaluated systematically. We used a conceptual model of sleep that included four physical domains of general interest to patients and investigators, and cover the breadth of this disorder: sleep initiation; sleep maintenance; sleep adequacy; and somnolence. We next considered the additional health-related quality-of-life (HR-QOL) domains of psychological and social functioning, progressing along the continuum to include health perceptions and opportunity. We then conducted a literature review to identify instruments and, using criteria developed by the Medical Outcomes Trust Scientific Advisory Committee, evaluated these instruments for their potential use in measuring sleep dysfunction. Twenty-two instruments were identified. Six instruments were found to include the four physical domains defined a priori (Basic Nordic Sleep Questionnaire, Leeds Sleep Evaluation Questionnaire, Medical Outcomes Study - Sleep Problems Measures, Pittsburgh Sleep Diary, Pittsburgh Sleep Quality Index, Self-Rated Sleep Questionnaire and the Sleep Dissatisfaction Questionnaire). Several additional instruments addressed at least some of the domains and thus may be useful for specific purposes. A few instruments addressed overall HR-QOL, but did not include all four domains of interest (Functional Outcomes of Sleep Questionnaire, Quality of Life in Insomniacs and the Sleep-Wake Activity Inventory). Two instruments had undergone extensive psychometric evaluation (Medical Outcomes Study - Sleep Problems Measures and Pittsburgh Sleep Quality Index), with only the latter reporting information about interpretability. Our review indicates that

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

    PubMed

    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.

  2. Implementing patient reported outcome measures (PROMs) in palliative care - users' cry for help

    PubMed Central

    2011-01-01

    Background Patient-reported outcome measurement (PROM) plays an increasingly important role in palliative care. A variety of measures exists and is used in clinical care, audit and research. However, little is known about professionals' views using these measures. The aim of this study is to describe the use and experiences of palliative care professionals with outcome measures. Methods A web-based online survey was conducted in Europe and Africa. Professionals working in clinical care, audit and research in palliative care were invited to the survey via national palliative care associations and various databases. Invitation e-mails were sent with a link to the questionnaire. Results Overall participation rate 42% (663/1592), overall completion rate 59% (392/663). The majority of respondents were female (63.4%), mean age 46 years (SD 9). 68.1% respondents from Europe and 73.3% from Africa had experiences with outcome measures in palliative care. Non-users reported time constraints, burden, lack of training and guidance as main reasons. In clinical care/audit, assessment of patients' situation, monitoring changes and evaluation of services were main reasons for use. Choice of OMs for research was influenced by validity of the instrument in palliative care and comparability with international literature. Main problems were related to patient characteristics, staff, and outcome measures. Participants expressed the need for more guidance and training in the use of PROMs. Conclusions Professionals need more support for the use and implementation of PROMs in clinical practice and research through training and guidance in order to improve patient care. PMID:21507232

  3. Patient-reported outcome measures: an on-line system empowering patient choice.

    PubMed

    Wilson, J; Arshad, F; Nnamoko, N; Whiteman, A; Ring, J; Roy, B

    2014-01-01

    An innovative web-based system was developed to allow patient-reported outcome measures (PROMs) to be easily administered. Stakeholders guided the design and implementation. The software gives patients access to their current and previous scores. This pilot study focused on patients undergoing arthroscopic subacromial decompression, evaluated using the Oxford shoulder score (OSS). Patients showing good improvement in their OSS were offered the choice to return for routine follow-up clinic appointments, or continue rehabilitation, reassured by their improved score. Thirty-six of 117 patients were eligible. Thirty of these (83%) were opted to avoid further clinics. PROMs 2.0 can be used for any medical intervention with a validated PROM. Evolution and refinement is ongoing. Funding has been granted for 12 primary and secondary healthcare trusts to implement PROMs 2.0. Further work is needed to assess economic impact, patient views and satisfaction with the process.

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

    PubMed Central

    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

    2016-01-01

    Objective The goal of the Outcome Measures in Rheumatology (OMERACT) 12 (2014) equity working group was to determine whether and how comprehensibility of patient-reported outcome measures (PROM) should be assessed, to ensure suitability for people with low literacy and differing cultures. Methods The English, Dutch, French, and Turkish Health Assessment Questionnaires and English and French Osteoarthritis Knee and Hip Quality of Life questionnaires were evaluated by applying 3 readability formulas: Flesch Reading Ease, Flesch-Kincaid grade level, and Simple Measure of Gobbledygook; and a new tool, 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. Results 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. Conclusion Future work will include consensus exercises on what methods are required to ensure PROM are appropriate for people with low literacy and different cultures. PMID:26077410

  5. An Introduction to Item Response Theory for Patient-Reported Outcome Measurement

    PubMed Central

    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

  6. Pragmatic Characteristics of Patient-Reported Outcome Measures are Important for Use in Clinical Practice

    PubMed Central

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

    2015-01-01

    Objective 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. While psychometric rigor is essential, this paper focuses on pragmatic characteristics of PROs that may enhance uptake into clinical practice. Methods Three sources were drawn upon 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; 3) the author' experience in developing practical PROs. Results 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, timeframe, intervals between options); 7) scoring (simplicity, interpretability); and 8) accessibility (nonproprietary, downloadable, available in different languages and for vulnerable groups, incorporated into electronic health records) Conclusion Balancing psychometric and pragmatic factors in the development of PROs is important for accelerating the incorporation of PROs into clinical practice. PMID:25962972

  7. Measuring Participation: The Patient-Reported Outcomes Measurement Information System Experience

    PubMed Central

    Bode, Rita K.; Hahn, Elizabeth A.; DeVellis, Robert; Cella, David

    2013-01-01

    Objectives To describe the lessons learned in the initial development of PROMIS social function item banks. Design Development and testing of two item pools within a general population to create item banks that measure ability-to-participate and satisfaction-with-participation in social activities. Setting Administration via the Internet. Participants General population members (N=956) of a national polling organization registry participated; data for 768 and 778 participants used in the analysis. Interventions Not applicable. Main Outcome Measures Measures of ability-to-participate and satisfaction-with-participation in social activities. Results Fifty six items measuring the ability-to-participate were essentially unidimensional but did not fit an IRT model. As a result, item banks were not developed for these items. Of the 56 items measuring satisfaction-with-participation, 14 items measuring social roles and 12 items measuring discretionary activities were unidimensional and met IRT model assumptions. Two 7-item short forms were also developed. Conclusions Four lessons, mostly concerning item content, were learned in the development of banks measuring social function. These lessons led to item revisions that are being tested in subsequent studies. PMID:20801282

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

    PubMed

    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

    2013-01-01

    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 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

  9. Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance.

    PubMed

    Banerjee, Anjan K; Okun, Sally; Edwards, I Ralph; Wicks, Paul; Smith, Meredith Y; Mayall, Stephen J; Flamion, Bruno; Cleeland, Charles; Basch, Ethan

    2013-12-01

    The Patient-Reported Outcomes Safety Event Reporting (PROSPER) Consortium was convened to improve safety reporting by better incorporating the perspective of the patient. PROSPER comprises industry, regulatory authority, academic, private sector and patient representatives who are interested in the area of patient-reported outcomes of adverse events (PRO-AEs). It has developed guidance on PRO-AE data, including the benefits of wider use and approaches for data capture and analysis. Patient-reported outcomes (PROs) encompass the full range of self-reporting, rather than only patient reports collected by clinicians using validated instruments. In recent years, PROs have become increasingly important across the spectrum of healthcare and life sciences. Patient-centred models of care are integrating shared decision making and PROs at the point of care; comparative effectiveness research seeks to include patients as participatory stakeholders; and industry is expanding its involvement with patients and patient groups as part of the drug development process and safety monitoring. Additionally, recent pharmacovigilance legislation from regulatory authorities in the EU and the USA calls for the inclusion of patient-reported information in benefit-risk assessment of pharmaceutical products. For patients, technological advancements have made it easier to be an active participant in one's healthcare. Simplified internet search capabilities, electronic and personal health records, digital mobile devices, and PRO-enabled patient online communities are just a few examples of tools that allow patients to gain increased knowledge about conditions, symptoms, treatment options and side effects. Despite these changes and increased attention on the perceived value of PROs, their full potential has yet to be realised in pharmacovigilance. Current safety reporting and risk assessment processes remain heavily dependent on healthcare professionals, though there are known limitations such

  10. Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance.

    PubMed

    Banerjee, Anjan K; Okun, Sally; Edwards, I Ralph; Wicks, Paul; Smith, Meredith Y; Mayall, Stephen J; Flamion, Bruno; Cleeland, Charles; Basch, Ethan

    2013-12-01

    The Patient-Reported Outcomes Safety Event Reporting (PROSPER) Consortium was convened to improve safety reporting by better incorporating the perspective of the patient. PROSPER comprises industry, regulatory authority, academic, private sector and patient representatives who are interested in the area of patient-reported outcomes of adverse events (PRO-AEs). It has developed guidance on PRO-AE data, including the benefits of wider use and approaches for data capture and analysis. Patient-reported outcomes (PROs) encompass the full range of self-reporting, rather than only patient reports collected by clinicians using validated instruments. In recent years, PROs have become increasingly important across the spectrum of healthcare and life sciences. Patient-centred models of care are integrating shared decision making and PROs at the point of care; comparative effectiveness research seeks to include patients as participatory stakeholders; and industry is expanding its involvement with patients and patient groups as part of the drug development process and safety monitoring. Additionally, recent pharmacovigilance legislation from regulatory authorities in the EU and the USA calls for the inclusion of patient-reported information in benefit-risk assessment of pharmaceutical products. For patients, technological advancements have made it easier to be an active participant in one's healthcare. Simplified internet search capabilities, electronic and personal health records, digital mobile devices, and PRO-enabled patient online communities are just a few examples of tools that allow patients to gain increased knowledge about conditions, symptoms, treatment options and side effects. Despite these changes and increased attention on the perceived value of PROs, their full potential has yet to be realised in pharmacovigilance. Current safety reporting and risk assessment processes remain heavily dependent on healthcare professionals, though there are known limitations such

  11. Item Banks for Measuring Emotional Distress From the Patient-Reported Outcomes Measurement Information System (PROMIS®): Depression, Anxiety, and Anger

    PubMed Central

    Pilkonis, Paul A.; Choi, Seung W.; Reise, Steven P.; Stover, Angela M.; Riley, William T.; Cella, David

    2011-01-01

    The authors report on the development and calibration of item banks for depression, anxiety, and anger as part of the Patient-Reported Outcomes Measurement Information System (PROMIS®). Comprehensive literature searches yielded an initial bank of 1,404 items from 305 instruments. After qualitative item analysis (including focus groups and cognitive interviewing), 168 items (56 for each construct) were written in a first person, past tense format with a 7-day time frame and five response options reflecting frequency. The calibration sample included nearly 15,000 respondents. Final banks of 28, 29, and 29 items were calibrated for depression, anxiety, and anger, respectively, using item response theory. Test information curves showed that the PROMIS item banks provided more information than conventional measures in a range of severity from approximately −1 to +3 standard deviations (with higher scores indicating greater distress). Short forms consisting of seven to eight items provided information comparable to legacy measures containing more items. PMID:21697139

  12. Systematic review of measurement properties of patient-reported outcome measures used in patients undergoing hip and knee arthroplasty

    PubMed Central

    Harris, Kristina; Dawson, Jill; Gibbons, Elizabeth; Lim, Chris R; Beard, David J; Fitzpatrick, Raymond; Price, Andrew J

    2016-01-01

    Objectives To identify patient-reported outcome measures (PROMs) that have been developed and/or used with patients undergoing hip or knee replacement surgery and to provide a shortlist of the most promising generic and condition-specific instruments. Methods A systematic review of the literature was performed to identify measures used in patients undergoing hip and knee replacement and extract and evaluate information on their methodological quality. Results Thirty-two shortlisted measures were reviewed for the quality of their measurement properties. On the basis of the review criteria, the measures with most complete evidence to date are the Oxford Hip Score (OHS) (for patients undergoing hip replacement surgery) and the Oxford Knee Score (OKS), with OKS-Activity and Participation Questionnaire (for patients undergoing knee replacement surgery). Conclusion A large number of these instruments lack essential evidence of their measurement properties (eg, validity, reliability, and responsiveness) in specific populations of patients. Further research is required on almost all of the identified measures. The best-performing condition-specific PROMs were the OKS, OHS, and Western Ontario and McMaster Universities Osteoarthritis Index. The best-performing generic measure was the Short Form 12. Researchers can use the information presented in this review to inform further psychometric studies of the reviewed measures. PMID:27524925

  13. TBI-QOL: Development and Calibration of Item Banks to Measure Patient Reported Outcomes Following Traumatic Brain Injury

    PubMed Central

    Tulsky, David S.; Kisala, Pamela A.; Victorson, David; Carlozzi, Noelle; Bushnik, Tamara; Sherer, Mark; Choi, Seung W.; Heinemann, Allen W.; Chiaravalloti, Nancy; Sander, Angelle M.; Englander, Jeffrey; Hanks, Robin; Kolakowsky-Hayner, Stephanie; Roth, Elliot; Gershon, Richard; Rosenthal, Mitchell; Cella, David

    2016-01-01

    Objective: To use a patient-centered approach or participatory action research design combined with advanced psychometrics to develop a comprehensive patient-reported outcomes (PRO) measurement system specifically for individuals with traumatic brain injury (TBI). This TBI Quality-of-Life (TBI-QOL) measurement system expands the work of other large PRO measurement initiatives, that is, the Patient-Reported Outcomes Measurement Information System and the Neurology Quality-of-Life measurement initiative. Setting: Five TBI Model Systems centers across the United States. Participants: Adults with TBI. Design: Classical and modern test development methodologies were used. Qualitative input was obtained from individuals with TBI, TBI clinicians, and caregivers of individuals with TBI through multiple methods, including focus groups, individual interviews, patient consultation, and cognitive debriefing interviews. Item pools were field tested in a large multisite sample (n = 675) and calibrated using item response theory methods. Main Outcomes Measures: Twenty-two TBI-QOL item banks/scales. Results: The TBI-QOL consists of 20 independent calibrated item banks and 2 uncalibrated scales that measure physical, emotional, cognitive, and social aspects of health-related quality of life. Conclusions: The TBI-QOL measurement system has potential as a common data element in TBI research and to enhance collection of health-related quality-of-life and PRO data in rehabilitation research and clinical settings. PMID:25931184

  14. Patient-reported outcome measures in a population of medically indigent patients with systemic lupus erythematosus in Puerto Rico

    PubMed Central

    Rodríguez-Rivera, Diana V; Rodríguez-Navedo, Yerania; Nieves-Plaza, Mariely; Vilá, Luis M

    2016-01-01

    Objective: To determine patient-reported outcomes measures in indigent patients with systemic lupus erythematosus receiving their healthcare through the Puerto Rico government managed care system and compare these measures with non-indigent patients treated in a private fee-for-service setting. Methods: A cross-sectional study was conducted in a cohort of 98 Puerto Ricans with systemic lupus erythematosus. Patients from the public group (n = 40) were treated in a university-based specialized systemic lupus erythematosus clinic and the private group (n = 58) in a community-based rheumatology practice. Demographic and clinical features and patient-reported outcomes measures per LupusPRO instrument were determined. LupusPRO captures quality-of-life measures in 12 domains. Differences among study groups were examined using chi-square, Fisher’s exact, t-tests, and the Wilcoxon signed-rank test. Results: The mean (standard deviation) age of the study population was 44.9 (12.0) years; 94 (95.9%) were women. Patients in the public setting were younger and were more likely to have renal disease and elevated anti-double-stranded DNA antibodies, and being treated with azathioprine and cyclophosphamide. Patients from the public sector were more likely to have better quality-of-life measures in the LupusPRO domains of pain/vitality and coping. No significant differences were observed for the domains of lupus symptoms, physical health, emotional health, body image, cognition, procreation, lupus medications, desires/goals, social support, and satisfaction with medical care. Conclusion: Despite having a lower socioeconomic status and worse clinical status, systemic lupus erythematosus patients from the public sector had equal or better patient-reported outcomes measures than those treated in the private setting. This favorable outcome may be associated with the comprehensive healthcare received by these patients in a specialized lupus clinic. PMID:27721978

  15. The VVSymQ® instrument: Use of a new patient-reported outcome measure for assessment of varicose vein symptoms

    PubMed Central

    Turner-Bowker, Diane M; Elash, Celeste A; Wright, David

    2015-01-01

    Introduction No existing patient-reported outcome instrument focuses solely on assessment of varicose veins symptoms that are bothersome to patients. Methods The VVSymQ® instrument is a five-item patient-reported outcome that assesses symptoms most important to patients with varicose veins (heaviness, achiness, swelling, throbbing and itching). This paper describes how the VVSymQ® instrument was incorporated into an electronic daily diary to monitor key outcomes over time and capture treatment benefit in two randomized, controlled, phase 3 clinical trials. Results Patients were highly compliant in completing the electronic daily diary, and the VVSymQ® instrument demonstrated ability to detect overall change and ability to detect change that is meaningful to patients. Conclusion The VVSymQ® instrument is a reliable, valid instrument responsive to measuring change in the patient experience of varicose vein symptoms pre- and post-intervention, and is uniquely focused on patient-reported symptoms compared with other widely used questionnaires completed by clinicians. PMID:26183669

  16. Using Patient-Reported Outcome Measures to Capture the Patient's Voice in Research and Care of Juvenile Idiopathic Arthritis.

    PubMed

    Hersh, Aimee O; Salimian, Parissa K; Weitzman, Elissa R

    2016-05-01

    Patient-reported outcome (PRO) measures provide a valuable window into how patients with juvenile idiopathic arthritis and their parents perceive their functioning, quality of life, and medication side effects in the context of their disease and treatment. Momentum behind adoption of PRO measures is increasing as these patient-relevant tools capture information pertinent to taking a patient-centered approach to health care and research. This article reviews the clinical and research utility of obtaining PROs across domains applicable to the experience of juvenile idiopathic arthritis and summarizes available self-report and parent-proxy PRO measures. Current challenges and limitations of PRO usage are discussed. PMID:27133493

  17. Item Banks for Measuring Emotional Distress from the Patient-Reported Outcomes Measurement Information System (PROMIS[R]): Depression, Anxiety, and Anger

    ERIC Educational Resources Information Center

    Pilkonis, Paul A.; Choi, Seung W.; Reise, Steven P.; Stover, Angela M.; Riley, William T.; Cella, David

    2011-01-01

    The authors report on the development and calibration of item banks for depression, anxiety, and anger as part of the Patient-Reported Outcomes Measurement Information System (PROMIS[R]). Comprehensive literature searches yielded an initial bank of 1,404 items from 305 instruments. After qualitative item analysis (including focus groups and…

  18. Methodological issues in measuring patient-reported outcomes: the agenda of the Work Group on Outcomes Assessment.

    PubMed

    Fowler, F J; Cleary, P D; Magaziner, J; Patrick, D L; Benjamin, K L

    1994-07-01

    The primary goal of the Inter-PORT work group on Outcomes Assessment is to foster methodological knowledge about the implications of various measure and design decisions for studies of the outcomes of treatment. A number of key methodological issues currently are unresolved and are in need of further study. These include: 1) the best questions to ask to assess how patients are affected by their treatments; 2) the comparative advantages of various study designs, including prospective cohorts, retrospective studies, and randomized clinical trials; 3) the way data collection decisions, such as mode of data collection and use of proxy respondents, affect study results; and 4) the best way to assess the significance of observed effects from patient, provider, and public policy perspectives. Studies conducted by the Patients Outcomes Research Teams (PORTs) are using diverse designs, measures, and data collection procedures. They provide a unique opportunity to further knowledge about methods of obtaining information about treatment outcomes. Through meetings, conferences, and publications, the Inter-PORT work group on Outcomes Assessment is trying to stimulate analyses aimed at methodological issues summarized in this paper and to ensure that new knowledge about methods is disseminated to a wide audience.

  19. Physiotherapists use of and perspectives on the importance of patient-reported outcome measures for shoulder dysfunction

    PubMed Central

    Michener, Lori A

    2014-01-01

    Background Many patient-reported outcome measures (PROs) for shoulder dysfunctions have acceptable psychometric properties. The present study examined current PRO usage and perceived importance. Methods Delegates at the 2010 International Congress of Shoulder and Elbow Therapists were invited to participate in this cross-sectional observational study. Research Electronic Data Capture (REDCap) web-based tools were used to design an online questionnaire, which was e-mailed to participants. Results Participants (n = 101) reflected an 84% response rate. PRO use was considered ‘extremely’ or ‘very’ important by the majority of clinicians (76%) and researchers (98%). Most commonly used as a primary outcome by clinicians and researchers, respectively, were the Disabilities of the Arm Shoulder Hand Questionnaire (DASH) (40%, 44%) and the Oxford Shoulder Scale (OSS) (36%, 22%) and, as secondary outcomes, the DASH (33%, 28%), OSS (17%, 8%), the Shoulder Pain and Disability Index (SPADI) (8%,18%), and American Shoulder and Elbow Surgeons standardized assessment form (ASES) (8%, 13%). Psychometric properties were rated as ‘extremely’ or ‘very’ important by 86% to 96% of participants. Conclusions The majority of shoulder therapists consider PRO use to be very important and psychometric properties to be critical in PRO selection. The DASH, OSS, SPADI and ASES are most commonly used in clinical practice and research studies. PMID:27582938

  20. Use of patient-reported outcomes to measure symptoms and health related quality of life in the clinic.

    PubMed

    Gilbert, Alexandra; Sebag-Montefiore, David; Davidson, Susan; Velikova, Galina

    2015-03-01

    There is increasing interest in the use of patient-reported outcomes (PROs) in routine practice in cancer care to measure symptoms and health related quality of life (HRQOL). PROs are designed to capture the patient's perspective of their care and treatment, and complement the traditional clinical outcomes of survival and toxicity assessment. Integrating routine collection and feedback of PROs has been found to improve care for patients on both an individual level, through improved communication and management of symptoms, and at an organizational level, by enabling aggregation of data to compare performance. This article reviews the benefits and challenges of introducing patient-reported assessments into routine clinical practice. Methods for choosing a questionnaire; collection and presentation of results; timing and frequency of administration as well as clinician training methods to aid the ability of clinicians to integrate the use of PROs into their own practice are described. Electronic PRO capture and integration with electronic health records seems to provide the most effective method for seamless integration into existing patient care pathways. Case studies from our own practice illustrate the issues raised. Electronic methods enabling immediate collection, scoring and interpretation of the data, as well as real-time data capture, email alert systems and individualized, online self-management advice may enable severe symptoms to be managed in a more timely manner. Evaluation methods are described to establish the effectiveness of the PRO intervention. Engaging stakeholders throughout the process of initial consultation and development, during delivery and evaluation is key to success. Future work needs to focus on the effectiveness of PROs in longer-term follow-up of patients in routine care and the relationship between the PRO severity grading and clinician severity grading using the Common Terminology Criteria of Adverse Events (CTCAE). PMID:25448486

  1. Development of an Online Library of Patient-Reported Outcome Measures in Gastroenterology: The GI-PRO Database

    PubMed Central

    Khanna, Puja; Agarwal, Nikhil; Khanna, Dinesh; Hays, Ron D.; Chang, Lin; Bolus, Roger; Melmed, Gil; Whitman, Cynthia B.; Kaplan, Robert M.; Ogawa, Rikke; Snyder, Bradley; Spiegel, Brennan M.R.

    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 the NIH Patient-Reported Outcome Measurement Information System (PROMIS®), we performed a systematic review to identify English-language GI PROs. We abstracted PRO items and developed an online searchable item database. We categorized symptoms into content “bins” to evaluate a framework for GI symptom reporting. Finally, we assigned a score for the methodological quality of each PRO represented in the published literature (0–20 range; higher indicates better). RESULTS We reviewed 15,697 titles (κ > 0.6 for title and abstract selection), from which we identified 126 PROs. Review of the PROs revealed eight GI symptom “bins”: (i) abdominal pain, (ii) bloat/gas, (iii) diarrhea, (iv) constipation, (v) bowel incontinence/soilage, (vi) heartburn/reflux, (vii) swallowing, and (viii) nausea/vomiting. In addition to these symptoms, the PROs covered four psychosocial domains: (i) behaviors, (ii) cognitions, (iii) emotions, and (iv) psychosocial impact. The quality scores were generally low (mean 8.88±4.19; 0 (min)−20 (max)). In addition, 51% did not include patient input in developing the PRO, and 41% provided no information on score interpretation. CONCLUSIONS GI PROs cover a wide range of biopsychosocial symptoms. Although plentiful, GI PROs are limited by low methodological quality. Our online PRO library (www.researchcore.org/gipro/) can help in selecting PROs for clinical and research purposes. PMID:24343547

  2. Patient-reported outcomes in multiple sclerosis: Relationships among existing scales and the development of a brief measure.

    PubMed

    Chua, Alicia S; Glanz, Bonnie I; Guarino, Anthony J; Cook, Sandra L; Greeke, Emily E; Little, Grace E; Chitnis, Tanuja; Healy, Brian C

    2015-11-01

    Several patient-reported outcome (PRO) measures are commonly used in multiple sclerosis (MS) research, but the relationship among items across measures is uncertain. We proposed to evaluate the associations between items from a standard battery of PRO measures used in MS research and to develop a brief, reliable and valid instrument measure by combining these items into a single measure. Subjects (N = 537) enrolled in CLIMB complete a PRO battery that includes the Center for Epidemiologic Studies Depression Scale, Medical Outcomes Study Modified Social Support Survey, Modified Fatigue Impact Scale and Multiple Sclerosis Quality of Life-54. Subjects were randomly divided into two samples: calibration (n = 269) and validation (n = 268). In the calibration sample, an Exploratory Factor Analysis (EFA) was used to identify latent constructs within the battery. The model constructed based on the EFA was evaluated in the validation sample using Confirmatory Factor Analysis (CFA), and reliability and validity were assessed for the final measure. The EFA in the calibration sample revealed an eight factor solution, and a final model with one second-order factor along with the eight first-order factors provided the best fit. The model combined items from each of the four parent measures, showing important relationships among the parent measures. When the model was fit using the validation sample, the results confirmed the validity and reliability of the model. A brief PRO for MS (BPRO-MS) that combines MS-related psychosocial and quality of life domains can be used to assess overall functioning in mildly disabled MS patients. PMID:26590669

  3. The Use of PROMIS and Assessment Center to Deliver Patient-Reported Outcome Measures in Clinical Research

    PubMed Central

    Gershon, Richard C.; Rothrock, Nan; Hanrahan, Rachel; Bass, Michael; Cella, David

    2013-01-01

    The Patient-Reported Outcomes Measurement Information System (PROMIS) was developed as one of the first projects funded by the NIH Roadmap for Medical Research Initiative to re-engineer the clinical research enterprise. The primary goal of PROMIS is to build item banks and short forms that measure key health outcome domains that are manifested in a variety of chronic diseases which could be used as a “common currency” across research projects. To date, item banks, short forms and computerized adaptive tests (CAT) have been developed for 13 domains with relevance to pediatric and adult subjects. To enable easy delivery of these new instruments, PROMIS built a web-based resource (Assessment Center) for administering CATs and other self-report data, tracking item and instrument development, monitoring accrual, managing data, and storing statistical analysis results. Assessment Center can also be used to deliver custom researcher developed content, and has numerous features that support both simple and complicated accrual designs (branching, multiple arms, multiple time points, etc.). This paper provides an overview of the development of the PROMIS item banks and details Assessment Center functionality. PMID:20847477

  4. Use of SMS and tablet computer improves the electronic collection of elective orthopaedic patient reported outcome measures

    PubMed Central

    Bradley, B; Williams, D

    2014-01-01

    Introduction Electronic patient reported outcome measures (PROMs) enable real time reporting back to the patient and medical team, comparison between similar patient cohorts and long-term cost effective outcome measurement. The primary objective of this three-phase pilot study was to measure uptake using a web-based PROM system following the introduction of two separate process improvements. Methods Eighty consecutive new elective orthopaedic patients in a single surgeon’s practice were recruited for the study. Patients in Group 1 (n=26) received only a letter reminding them to complete a symptom score. Those in Group 2 (n=31) also received a reminder SMS (short message service) message via their mobile or home telephone and those in Group 3 (n=23) also had access to a tablet computer in clinic. Results The mean patient age in Group 1 was 55 years (range: 24–80 years), in Group 2 it was 60 years (range: 23–85 years) and in Group 3 it was 58 years (range: 37–78 years) (p>0.05). Overall, 79% of patients had internet access, and 35% of Group 1, 55% of Group 2 and 74% of Group 3 recorded an electronic PROM score (p=0.02). In Group 3, 94% of patients listed for an operation completed an electronic PROM score (p=0.006). Conclusions Collecting PROM data effectively in everyday clinical practice is challenging. Electronic collection should meet that challenge and improve healthcare delivery but it is in its infancy. This pilot study shows that the combination of an SMS reminder and access to a Wi-Fi enabled tablet computer in the clinic setting enabled 94% of patients listed for an operation to complete a score on a web-based clinical outcomes system. Additional staff training and telephone call reminders may further improve uptake. PMID:24992417

  5. Construct validity of the Patient Reported Outcomes Measurement Information System (PROMIS®) Gastrointestinal Symptom Scales in Systemic Sclerosis

    PubMed Central

    Nagaraja, Vivek; Hays, Ron D.; Khanna, Puja P.; Spiegel, Brennan M.R.; Chang, Lin; Melmed, Gil Y.; Bolus, Roger; Khanna, Dinesh

    2014-01-01

    Objective Gastrointestinal (GI) involvement is common in patients with systemic sclerosis (SSc). The Patient-Reported Outcomes Measurement Information System (PROMIS®) GI Symptom item bank captures upper and lower GI symptoms (reflux, disrupted swallowing, nausea/vomiting, belly pain, gas /bloating /flatulence, diarrhea, constipation, and fecal incontinence). The objective of this study was to evaluate the construct validity of the PROMIS-GI bank in SSc. Methods 167 patients with SSc were administered the PROMIS GI bank and the UCLA Scleroderma Clinical Trials Consortium Gastrointestinal Scale (GIT 2.0) instrument. GIT 2.0 is a multi-item instrument that measures SSc-associated GI symptoms. Product-moment correlations and a multitrait-multimethod analysis of the PROMIS GI scales with the GIT 2.0 symptom scales were used to evaluate convergent and discriminant validity. Results Patients with SSc GI involvement had PROMIS GI scale scores 0.2–0.7 SD worse than US population. Correlations among scales measuring the same domains for the PROMIS GI and GIT 2.0 measures were large, ranging from 0.61 to 0.87 (average r = 0.77). The average correlation between different symptom scales was 0.22, supporting discriminant validity. Conclusion This study provides support for the construct validity of the PROMIS GI scales in SSc. Future research is needed to assess the responsiveness to change of these scales in patients with SSc. PMID:24692332

  6. Minimally important differences for Patient Reported Outcomes Measurement Information System pain interference for individuals with back pain

    PubMed Central

    Amtmann, Dagmar; Kim, Jiseon; Chung, Hyewon; Askew, Robert L; Park, Ryoungsun; Cook, Karon F

    2016-01-01

    Background The minimally important difference (MID) refers to the smallest change that is sufficiently meaningful to carry implications for patients’ care. MIDs are necessary to guide the interpretation of scores. This study estimated MID for the Patient Reported Outcomes Measurement Information System (PROMIS) pain interference (PI). Methods Study instruments were administered to 414 people who participated in two studies that included treatment with low back pain (LBP; n=218) or depression (n=196). Participants with LBP received epidural steroid injections and participants with depression received antidepressants, psychotherapy, or both. MIDs were estimated for the changes in LBP. MIDs were included only if a priori criteria were met (ie, sample size ≥10, Spearman correlation ≥0.3 between anchor measures and PROMIS-PI scores, and effect size range =0.2–0.8). The interquartile range (IQR) of MID estimates was calculated. Results The IQR ranged from 3.5 to 5.5 points. The lower bound estimate of the IQR (3.5) was greater than mean of standard error of measurement (SEM) both at time 1 (SEM =2.3) and at time 2 (SEM =2.5), indicating that the estimate of MID exceeded measurement error. Conclusion Based on our results, researchers and clinicians using PROMIS-PI can assume that change of 3.5 to 5.5 points in comparisons of mean PROMIS-PI scores of people with LBP can be considered meaningful. PMID:27175093

  7. Patient-reported outcome measures in arthroplasty registries Report of the Patient-Reported Outcome Measures Working Group of the International Society of Arthroplasty Registries Part II. Recommendations for selection, administration, and analysis.

    PubMed

    Rolfson, Ola; Bohm, Eric; Franklin, Patricia; Lyman, Stephen; Denissen, Geke; Dawson, Jill; Dunn, Jennifer; Eresian Chenok, Kate; Dunbar, Michael; Overgaard, Søren; Garellick, Göran; Lübbeke, Anne

    2016-07-01

    - 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 question ("During the past 4 weeks, how would you describe the pain you usually have in your [right/left] [hip/knee]?"; response: none, very mild, mild, moderate, or severe) and a single-item satisfaction outcome ("How satisfied are you with your [right/left] [hip/knee] replacement?"; response: very unsatisfied, dissatisfied, neutral, satisfied, or very satisfied). Survey logistics include patient instructions, paper- and electronic-based data collection, reminders for follow-up, centralized as opposed to hospital-based follow-up, sample size, patient- or joint-specific evaluation, collection intervals, frequency of response, missing values, and factors in establishing a PROMs registry program. The Working Group recommends including age, sex, diagnosis at joint, general health status preoperatively, and joint pain and function score in case-mix adjustment models. Interpretation and statistical analysis 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 and 1 year after surgery, a threshold of 60% for acceptable frequency of response, documentation of non-responders, and documentation of incomplete or missing data. PMID

  8. Patient-Reported Outcomes in Cancer Clinical Trials: Measuring Symptomatic Adverse Events With the National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

    PubMed

    Kluetz, Paul G; Chingos, Diana T; Basch, Ethan M; Mitchell, Sandra A

    2016-01-01

    Systematic capture of the patient perspective can inform the development of new cancer therapies. Patient-reported outcomes (PROs) are commonly included in cancer clinical trials; however, there is heterogeneity in the constructs, measures, and analytic approaches that have been used making these endpoints challenging to interpret. There is renewed effort to identify rigorous methods to obtain high-quality and informative PRO data from cancer clinical trials. In this setting, PROs are used to address specific research objectives, and an important objective that spans the product development life cycle is the assessment of safety and tolerability. The U.S. Food and Drug Administration's (FDA) Office of Hematology and Oncology Products (OHOP) has identified symptomatic adverse events (AEs) as a central PRO concept, and a systematic assessment of patient-reported symptomatic AEs can provide data to complement clinician reporting. The National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is being evaluated by multiple stakeholders, including the FDA, and is considered a promising tool to provide a standard yet flexible method to assess symptomatic AEs from the patient perspective. In this article, we briefly review the FDA OHOP's perspective on PROs in cancer trials submitted to the FDA and focus on the assessment of symptomatic AEs using PRO-CTCAE. We conclude by discussing further work that must be done to broaden the use of PRO-CTCAE as a method to provide patient-centered data that can complement existing safety and tolerability assessments across cancer clinical trials. PMID:27249687

  9. Using the bootstrap to establish statistical significance for relative validity comparisons among patient-reported outcome measures

    PubMed Central

    2013-01-01

    Background Relative validity (RV), a ratio of ANOVA F-statistics, is often used to compare the validity of patient-reported outcome (PRO) measures. We used the bootstrap to establish the statistical significance of the RV and to identify key factors affecting its significance. Methods Based on responses from 453 chronic kidney disease (CKD) patients to 16 CKD-specific and generic PRO measures, RVs were computed to determine how well each measure discriminated across clinically-defined groups of patients compared to the most discriminating (reference) measure. Statistical significance of RV was quantified by the 95% bootstrap confidence interval. Simulations examined the effects of sample size, denominator F-statistic, correlation between comparator and reference measures, and number of bootstrap replicates. Results The statistical significance of the RV increased as the magnitude of denominator F-statistic increased or as the correlation between comparator and reference measures increased. A denominator F-statistic of 57 conveyed sufficient power (80%) to detect an RV of 0.6 for two measures correlated at r = 0.7. Larger denominator F-statistics or higher correlations provided greater power. Larger sample size with a fixed denominator F-statistic or more bootstrap replicates (beyond 500) had minimal impact. Conclusions The bootstrap is valuable for establishing the statistical significance of RV estimates. A reasonably large denominator F-statistic (F > 57) is required for adequate power when using the RV to compare the validity of measures with small or moderate correlations (r < 0.7). Substantially greater power can be achieved when comparing measures of a very high correlation (r > 0.9). PMID:23721463

  10. A methodology for successfully producing global translations of patient reported outcome measures for use in multiple countries.

    PubMed

    Two, Rebecca; Verjee-Lorenz, Aneesa; Clayson, Darren; Dalal, Mehul; Grotzinger, Kelly; Younossi, Zobair M

    2010-01-01

    The production of accurate and culturally relevant translations of patient reported outcome (PRO) measures is essential for the success of international clinical trials. Although there are many reports in publication regarding the translation of PRO measures, the techniques used to produce single translations for use in multiple countries (global translations) are not well documented. This article addresses this apparent lack of documentation and presents the methodology used to create global translations of the Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV). The challenges of creating a translation for use in multiple countries are discussed, and the criteria for a global translation project explained. Based on a thorough translation and linguistic validation methodology including a concept elaboration, multiple forward translations, two back translations, reviews by in-country clinicians and the instrument developer, pilot testing in each target country and multiple sets of proofreading, the key concept of the global translation methodology is consistent international harmonization, achieved through the involvement of linguists from each target country at every stage of the process. This methodology enabled the successful resolution of the translation issues encountered, and resulted in consistent translations of the CLDQ-HCV that were linguistically and culturally appropriate for all target countries.

  11. A methodology for successfully producing global translations of patient reported outcome measures for use in multiple countries.

    PubMed

    Two, Rebecca; Verjee-Lorenz, Aneesa; Clayson, Darren; Dalal, Mehul; Grotzinger, Kelly; Younossi, Zobair M

    2010-01-01

    The production of accurate and culturally relevant translations of patient reported outcome (PRO) measures is essential for the success of international clinical trials. Although there are many reports in publication regarding the translation of PRO measures, the techniques used to produce single translations for use in multiple countries (global translations) are not well documented. This article addresses this apparent lack of documentation and presents the methodology used to create global translations of the Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV). The challenges of creating a translation for use in multiple countries are discussed, and the criteria for a global translation project explained. Based on a thorough translation and linguistic validation methodology including a concept elaboration, multiple forward translations, two back translations, reviews by in-country clinicians and the instrument developer, pilot testing in each target country and multiple sets of proofreading, the key concept of the global translation methodology is consistent international harmonization, achieved through the involvement of linguists from each target country at every stage of the process. This methodology enabled the successful resolution of the translation issues encountered, and resulted in consistent translations of the CLDQ-HCV that were linguistically and culturally appropriate for all target countries. PMID:19695006

  12. The level of association between functional performance status measures and patient-reported outcomes in cancer patients: a systematic review

    PubMed Central

    Andreotti, Charissa F.; Roberts, Kailey E.; Saracino, Rebecca M.; Hernandez, Marisol; Basch, Ethan

    2016-01-01

    Purpose The process of assessing patient symptoms and functionality using patient-reported outcomes (PROs) and functional performance status (FPS) is an essential aspect of patient-centered oncology research and care. However, PRO and FPS measures are often employed separately or inconsistently combined. Thus, the purpose of this study was to conduct a systematic review of the level of association between PRO and FPS measures to determine their differential or combined utility. Methods A systematic search was conducted using five databases (1966 to February 2014) to identify studies that described an association between PRO and FPS. Studies were excluded if they were non-cancer specific, did not include adults aged 18 or older, or were review articles. Publications were selected for review by consensus among two authors, with a third author arbitrating as needed. Results A total of 18 studies met inclusion criteria. FPS was primarily assessed by clinicians using the ECOG Performance Status or Karnofsky Performance Status measures. PROs were captured using a variety of measures, with numerous domains assessed (e.g., pain, fatigue, and general health status). Concordance between PROs and FPS measures was widely variable, falling in the low to moderate range (0.09–0.72). Conclusions Despite consistency in the method of capture of PROs or FPS, domain capture varied considerably across reviewed studies. Irrespective of the method of capturing PROs or FPS, the quantified level of association between these two areas was moderate at best, providing evidence that FPS and PRO assessments offer unique information to assist clinicians in their decision-making. PMID:26314706

  13. Item Banks for Alcohol Use from the Patient-Reported Outcomes Measurement Information System (PROMIS): Use, Consequences, and Expectancies

    PubMed Central

    Pilkonis, Paul A.; Yu, Lan; Colditz, Jason; Dodds, Nathan; Johnston, Kelly L.; Maihoefer, Catherine; Stover, Angela M.; Daley, Dennis C.; McCarty, Dennis

    2012-01-01

    Background We report on the development and calibration of item banks for alcohol use, negative and positive consequences of alcohol use, and negative and positive expectancies regarding drinking as part of the Patient-Reported Outcomes Measurement Information System (PROMIS). Methods Comprehensive literature searches yielded an initial bank of more than 5,000 items from over 200 instruments. After qualitative item analysis (including focus groups and cognitive interviewing), 141 items were included in field testing. Items for alcohol use and consequences were written in a first-person, past-tense format with a 30-day time frame and 5 response options reflecting frequency. Items for expectancies were written in a third-person, present-tense format with no time frame specified and 5 response options reflecting intensity. The calibration sample included 1,407 respondents, 1,000 from the general population (ascertained through an internet panel) and 407 from community treatment programs participating in the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN). Results Final banks of 37, 31, 20, 11, and 9 items (108 total items) were calibrated for alcohol use, negative consequences, positive consequences, negative expectancies, and positive expectancies, respectively, using item response theory (IRT). Seven-item static short forms were also developed from each item bank. Conclusions Test information curves showed that the PROMIS item banks provided substantial information in a broad range of severity, making them suitable for treatment, observational, and epidemiological research. PMID:23206377

  14. Reliability of a patient-reported outcome measure in schizophrenia: Results from back-to-back self-ratings.

    PubMed

    Takeuchi, Hiroyoshi; Fervaha, Gagan; Remington, Gary

    2016-10-30

    This study aimed to assess patient's capacity to perform a patient-reported outcome (PRO) measure (i.e., a self-rating scale) and examine its relationship with clinical characteristics including cognition. Fifty patients with schizophrenia were asked to rate the Subjective Well-being under Neuroleptics scale - Short form (SWNS) twice; the second rating was started immediately after they completed the first to minimize the gap between ratings. At the same time, the Positive and Negative Symptoms Scale (PANSS) and Brief Neurocognitive Assessment (BNA) were administered. The correlations between the two ratings for the SWNS total and each item scores were high (rs=0.94 and rs=0.60-0.84, respectively); however, for 16 (80%) of 20 items, 5 or more patients (i.e., ≥10%) demonstrated a>1 point score difference. There was no significant correlation between the SWNS total score difference and any clinical characteristics including age, education duration, illness duration, antipsychotic dose, psychopathology, and cognition. In contrast, the number of items with a>1 point score difference was significantly correlated with disorganized symptoms and overall severity (rs=0.29 for both), as well as working memory and global cognition (rs=-0.41 and rs=-0.40, respectively). These findings suggest that PROs should be interpreted with caution in patients with schizophrenia with prominent disorganization and cognitive impairment. PMID:27543916

  15. Application of patient-reported outcome measures (PROMs) data to estimate cost-effectiveness of hernia surgery in England

    PubMed Central

    Coronini-Cronberg, Sophie; Appleby, John; Thompson, James

    2013-01-01

    Objectives To demonstrate potential uses of nationally collected patient-reported outcome measures (PROMs) data to estimate cost-effectiveness of hernia surgery. Design Cost-utility model populated with national PROMs, National Reference Cost and Hospital Episodes Statistics data. Setting Hospitals in England that provided elective inguinal hernia repair surgery for NHS patients between 1 April 2009 and 31 March 2010. Participants Patients >18 years undergoing NHS-funded elective hernia surgery in English hospitals who completed PROMs questionnaires. Main outcome measures Change in quality-adjusted life year (QALY) following surgery; cost per QALY of surgery by acute provider hospital; health gain and cost per QALY by surgery type received (laparoscopic or open hernia repair). Results The casemix-adjusted, discounted (at 3.5%) and degraded (over 25 years) mean change in QALYs following elective hernia repair surgery is 0.826 (95% CI, 0.793–0.859) compared to a counterfactual of no treatment. Patients undergoing laparoscopic surgery show a significantly greater gain in health-related quality of life (EQ-5D index change, 0.0915; 95% CI, 0.0850–0.0979) with an estimated gain of 0.923 QALYS (95% CI, 0.859–0.988) compared to those having open repair (EQ-5D index change, 0.0806; 95% CI, 0.0771–0.0841) at 0.817 QALYS (95% CI, 0.782–0.852). The average cost of hernia surgery in England is £1554, representing a mean cost per QALY of £1881. The mean cost of laparoscopic and open hernia surgery is equivocal (£1421 vs. £1426 respectively) but laparoscopies appear to offer higher cost-utility at £1540 per QALY, compared to £1746 per QALY for open surgery. Conclusions Routine PROMs data derived from NHS patients could be usefully analyzed to estimate health outcomes and cost-effectiveness of interventions to inform decision-making. This analysis suggests elective hernia surgery offers value-for-money, and laparoscopic repair is more clinically effective and

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

    PubMed Central

    Kleijn, Gitta; Post, Lenneke; Witte, Birgit I.; Bohlmeijer, Ernst T.; Westerhof, Gerben J.; Cuijpers, Pim; Verdonck-de Leeuw, Irma M.

    2016-01-01

    Purpose 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. Methods 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. Results 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). Conclusion The NEIS has good psychometric characteristics to assess ego-integrity and despair among cancer patients. PMID:27195750

  17. Monitoring rheumatoid arthritis using an algorithm based on patient-reported outcome measures: a first step towards personalised healthcare

    PubMed Central

    Hendrikx, Jos; Fransen, Jaap; van Riel, Piet L C M

    2015-01-01

    Objectives The objective of this proof of concept study was to evaluate alerts generated by a patient-reported outcome measure (PROM)-based algorithm for monitoring patients with rheumatoid arthritis (RA). Methods The algorithm was constructed using an example PROM score of an equally weighted mean of visual analogue scale (VAS) general health, VAS disease activity and VAS pain. Based on the PROM score, red flags are generated in 2 instances: the target level of disease activity is not met; change in disease activity surpasses an early alert threshold. To reduce false alarms, 3 consecutive red flags are needed to trigger an alert to the physician. Time series data from patients included consecutively in the practice-based Nijmegen Early RA cohort were analysed to select an appropriate autoregressive integrated moving average (ARIMA) model. This allowed for advanced interpolation of PROM scores and weekly data evaluation. Alerts were evaluated against disease-modifying antirheumatic drug (DMARD)/biologic medication intensification registered in the cohort. Results Data of 165 patients followed in their second year postdiagnosis were analysed. In 89.8% of 716 visits, the algorithm did not generate an alert and medication was not escalated. Positive predictive value, sensitivity and specificity were 24.6%, 55.6% and 69.7%, respectively. Comparable performance was found when analyses were stratified for baseline Disease Activity Score 28-joint count (DAS28) level. Conclusions When using the algorithm to screen scheduled visits, the overall chance of missing patients in need of medication intensification is low. These findings provide evidence that an off-site monitoring system could aid in optimising the number and timing of face-to-face consultations of patients with their rheumatologists. PMID:26629364

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

    PubMed Central

    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

  19. Gaining the Patient Reported Outcomes Measurement Information System (PROMIS) Perspective in Chronic Kidney Disease: a Midwest Pediatric Nephrology Consortium study

    PubMed Central

    Selewski, David T.; Massengill, Susan F.; Troost, Jonathan P.; Wickman, Larysa; Messer, Kassandra L.; Herreshoff, Emily; Bowers, Corinna; Ferris, Maria E.; Mahan, John D.; Greenbaum, Larry A.; MacHardy, Jackie; Kapur, Gaurav; Chand, Deepa H.; Goebel, Jens; Barletta, Gina Marie; Geary, Denis; Kershaw, David B.; Pan, Cynthia G.; Gbadegesin, Rasheed; Hidalgo, Guillermo; Lane, Jerome C.; Leiser, Jeffrey D.; Song, Peter X.; Thissen, David; Liu, Yang; Gross, Heather E.; DeWalt, Darren A.; Gipson, Debbie S.

    2014-01-01

    Background and Objectives Chronic kidney disease is a persistent chronic health condition commonly seen in pediatric nephrology programs. Our study aims to evaluate the sensitivity of the Patient Reported Outcomes Measurement Information System (PROMIS) pediatric instrument to indicators of disease severity and activity in pediatric chronic kidney disease. Methods This cross sectional study included 233 children 8–17 years old with chronic kidney disease from 16 participating institutions in North America. Disease activity indicators, including hospitalization in the previous 6 months, edema, and number of medications consumed daily, as well as disease severity indicators of kidney function and coexisting medical conditions were captured. PROMIS domains, including depression, anxiety, social-peer relationships, pain interference, fatigue, mobility, and upper extremity function, were administered via web-based questionnaires. Absolute effect sizes (AES) were generated to demonstrate the impact of disease on domain scores. Four children were excluded because of missing GFR estimations. Results 221 of the 229 children included in the final analysis completed the entire PROMIS questionnaire. Unadjusted PROMIS domains were responsive to chronic kidney disease activity indicators and number of coexisting conditions. PROMIS domain scores were worse in the presence of recent hospitalizations (depression AES 0.33, anxiety AES 0.42, pain interference AES 0.46, fatigue AES 0.50, mobility AES 0.49), edema (depression AES 0.50, anxiety AES 0.60, pain interference AES 0.77, mobility AES 0.54) and coexisting medical conditions (social peer-relationships AES 0.66, fatigue AES 0.83, mobility AES 0.60, upper extremity function AES 0.48). Conclusions The PROMIS pediatric domains of depression, anxiety, social-peer relationships, pain interference, and mobility were sensitive to the clinical status of children with chronic kidney disease in this multi-center cross sectional study

  20. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance.

    PubMed

    2006-10-11

    This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling (see appendix point 1). It does not address the use of PRO instruments for purposes beyond evaluation of claims made about a drug or medical product in its labeling. By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their endpoint discussions with the FDA during the product development process, streamline the FDA's review of PRO endpoint adequacy, and provide optimal information about the patient's perspective of treatment benefit at the time of product approval. A PRO is a measurement of any aspect of a patient's health status that comes directly from the patient (i.e., without the interpretation of the patient's responses by a physician or anyone else). In clinical trials, a PRO instrument can be used to measure the impact of an intervention on one or more aspects of patients' health status, hereafter referred to as PRO concepts, ranging from the purely symptomatic (response of a headache) to more complex concepts (e.g., ability to carry out activities of daily living), to extremely complex concepts such as quality of life, which is widely understood to be a multidomain concept with physical, psychological, and social components. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient perspective. For this data to be meaningful, however, there should be evidence that the PRO instrument effectively measures the particular concept that is studied. Generally, findings measured by PRO instruments may be used to support claims in approved product labeling if the claims are derived from adequate and well-controlled investigations that use PRO instruments that reliably

  1. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance

    PubMed Central

    2006-01-01

    This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling (see appendix point 1). It does not address the use of PRO instruments for purposes beyond evaluation of claims made about a drug or medical product in its labeling. By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their endpoint discussions with the FDA during the product development process, streamline the FDA's review of PRO endpoint adequacy, and provide optimal information about the patient's perspective of treatment benefit at the time of product approval. A PRO is a measurement of any aspect of a patient's health status that comes directly from the patient (i.e., without the interpretation of the patient's responses by a physician or anyone else). In clinical trials, a PRO instrument can be used to measure the impact of an intervention on one or more aspects of patients' health status, hereafter referred to as PRO concepts, ranging from the purely symptomatic (response of a headache) to more complex concepts (e.g., ability to carry out activities of daily living), to extremely complex concepts such as quality of life, which is widely understood to be a multidomain concept with physical, psychological, and social components. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient perspective. For this data to be meaningful, however, there should be evidence that the PRO instrument effectively measures the particular concept that is studied. Generally, findings measured by PRO instruments may be used to support claims in approved product labeling if the claims are derived from adequate and well-controlled investigations that use PRO instruments that reliably

  2. Radiotherapy in implant-based immediate breast reconstruction: risk factors, surgical outcomes, and patient-reported outcome measures in a large Swedish multicenter cohort.

    PubMed

    Eriksson, Max; Anveden, Lotta; Celebioglu, Fuat; Dahlberg, Kristina; Meldahl, Ingrid; Lagergren, Jakob; Eriksen, Catharina; de Boniface, Jana

    2013-12-01

    The purpose of this large cohort study was to analyze the effects of prior and postoperative radiotherapy (RT) on surgical outcomes and patient-reported outcome measures (PROMs) in implant-based immediate breast reconstruction (IBR). All breast cancer patients (n = 725, of whom 29 had bilateral IBR) operated with implant-based IBR at four Stockholm hospitals from 2007 to 2011 were included. The median follow-up was 43 months. Three groups were compared: no RT (n = 386), prior RT (n = 64), and postoperative RT (n = 304). Outcomes were IBR failure (implant loss with or without secondary autologous reconstruction), unplanned reoperations, and PROMs, as measured by the BreastQ(®) questionnaire. IBR failure occurred in 22/386 (6 %) of non-irradiated cases, 16/64 (25 %) after prior and 45/304 (15 %) after postoperative RT (p < 0.001). Failure risk was higher after prior than postoperative RT (HR 9.28 vs. 3.08). Further risk factors were high BMI, less surgeon reconstructive experience, and postoperative infection, while the use of permanent implants lowered the risk of IBR failure. The estimated 5 years IBR failure rate was 10.4 % for non-irradiated, 28.2 % for previously and 25.2 % for postoperatively irradiated patients (p < 0.001). At least one unplanned reoperation occurred in 169/384 of non-irradiated (44 %), 42/64 (66 %) of previously, and 180/303 (59 %) of postoperatively irradiated breasts (p < 0.001). Further contributing factors were the use of one-stage expander and permanent implants, less surgeon reconstructive experience, and smoking. RT significantly impaired scores on all scales of the BreastQ(®). However, a clear majority of women in all groups would choose IBR again. Implant-based IBR remains a feasible option for women undergoing mastectomy as patient satisfaction levels are high. After prior RT, however, autologous alternatives should be considered.

  3. Can we agree on patient-reported outcome measures for assessing hematopoietic cell transplantation patients? A study from the CIBMTR and BMT CTN.

    PubMed

    Shaw, B E; Lee, S J; Horowitz, M M; Wood, W A; Rizzo, J D; Flynn, K E

    2016-09-01

    Much research into the impact of hematopoietic cell transplantation (HCT) on recipients' symptoms, functioning and health-related quality of life uses diverse patient-reported outcome (PRO) measures. Robust conclusions regarding PROs in HCT patients are constrained by methodological issues, including the use of multiple different and noncomparable assessment measures. We reviewed 114 publications addressing PROs in HCT patients. Although three multi-item measures were most frequently used (FACT-BMT, n=28; European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30, n=26; and SF-36, n=26), 25 additional measures were used in more than one study. Another 50 measures were used in single studies. Over 50% of studies used more than one measure. We recommend that the field agrees upon a set of measures to address the core domains important to patients, to reduce heterogeneity and allow comparisons across studies and between different populations. Measures should be available in a free and easily accessible manner internationally. We discuss the relative benefits of the National Institutes of Health-supported Patient-Reported Outcomes Measurement Information System (PROMIS) system to achieve these goals. To further address these issues, the Blood and Marrow Transplant Clinical Trials Network has recently created a task force to implement PROMIS measures alongside traditional PRO measures in future clinical trials. Robust comparisons between measures in this setting may allow for the development of a standard for HCT patients. PMID:27159181

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

    PubMed Central

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

    2016-01-01

    Objectives 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. Design Retrospective analysis of prospectively collected data. Setting Single centre series. Outpatient clinics at an elective foot and ankle unit in the UK. Participants All new adult patients attending elective orthopaedic outpatient clinics over a 32-month period. Interventions 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. Outcome measures 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. Results 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 (p<0.001). Conclusions This study

  5. Patient-reported outcomes in obsessive-compulsive disorder.

    PubMed

    Subramaniam, Mythily; Soh, Pauline; Ong, Clarissa; Esmond Seow, Lee Seng; Picco, Louisa; Vaingankar, Janhavi Ajit; Chong, Siow Ann

    2014-06-01

    The purpose of the article was to provide an overview of patient-reported outcomes (PROs) and related measures that have been examined in the context of obsessive-compulsive disorder (OCD). The current review focused on patient-reported outcome measures (PROMs) that evaluated three broad outcome domains: functioning, health-related quality of life (HRQoL), and OCD-related symptoms. The present review ultimately included a total of 155 unique articles and 22 PROMs. An examination of the PROs revealed that OCD patients tend to suffer from significant functional disability, and report lower HRQoL than controls. OCD patients report greater symptom severity than patients with other mental disorders and evidence indicates that PROMs are sensitive to change and may be even better than clinician-rated measures at predicting treatment outcomes. Nonetheless, it should be noted that the measures reviewed lacked patient input in their development. Future research on PROMs must involve patient perspectives and include rigorous psychometric evaluation of these measures.

  6. Patient-reported outcomes in obsessive-compulsive disorder

    PubMed Central

    Subramaniam, Mythily; Soh, Pauline; Ong, Clarissa; Esmond Seow, Lee Seng; Picco, Louisa; Vaingankar, Janhavi Ajit; Chong, Siow Ann

    2014-01-01

    The purpose of the article was to provide an overview of patient-reported outcomes (PROs) and related measures that have been examined in the context of obsessive-compulsive disorder (OCD). The current review focused on patient-reported outcome measures (PROMs) that evaluated three broad outcome domains: functioning, health-related quality of life (HRQoL), and OCD-related symptoms. The present review ultimately included a total of 155 unique articles and 22 PROMs. An examination of the PROs revealed that OCD patients tend to suffer from significant functional disability, and report lower HRQoL than controls. OCD patients report greater symptom severity than patients with other mental disorders and evidence indicates that PROMs are sensitive to change and may be even better than clinician-rated measures at predicting treatment outcomes. Nonetheless, it should be noted that the measures reviewed lacked patient input in their development. Future research on PROMs must involve patient perspectives and include rigorous psychometric evaluation of these measures. PMID:25152661

  7. How to routinely collect data on patient-reported outcome and experience measures in renal registries in Europe: an expert consensus meeting.

    PubMed

    Breckenridge, Kate; Bekker, Hillary L; Gibbons, Elizabeth; van der Veer, Sabine N; Abbott, Denise; Briançon, Serge; Cullen, Ron; Garneata, Liliana; Jager, Kitty J; Lønning, Kjersti; Metcalfe, Wendy; Morton, Rachael L; Murtagh, Fliss E M; Prutz, Karl; Robertson, Susan; Rychlik, Ivan; Schon, Steffan; Sharp, Linda; Speyer, Elodie; Tentori, Francesca; Caskey, Fergus J

    2015-10-01

    Despite the potential for patient-reported outcome measures (PROMs) and experience measures (PREMs) to enhance understanding of patient experiences and outcomes they have not, to date, been widely incorporated into renal registry datasets. This report summarizes the main points learned from an ERA-EDTA QUEST-funded consensus meeting on how to routinely collect PROMs and PREMs in renal registries in Europe. In preparation for the meeting, we surveyed all European renal registries to establish current or planned efforts to collect PROMs/PREMs. A systematic review of the literature was performed. Publications reporting barriers and/or facilitators to PROMs/PREMs collection by registries were identified and a narrative synthesis undertaken. A group of renal registry representatives, PROMs/PREMs experts and patient representatives then met to (i) share any experience renal registries in Europe have in this area; (ii) establish how patient-reported data might be collected by understanding how registries currently collect routine data and how patient-reported data is collected in other settings; (iii) harmonize the future collection of patient-reported data by renal registries in Europe by agreeing upon preferred instruments and (iv) to identify the barriers to routine collection of patient-reported data in renal registries in Europe. In total, 23 of the 45 European renal registries responded to the survey. Two reported experience in collecting PROMs and three stated that they were actively exploring ways to do so. The systematic review identified 157 potentially relevant articles of which 9 met the inclusion criteria and were analysed for barriers and facilitators to routine PROM/PREM collection. Thirteen themes were identified and mapped to a three-stage framework around establishing the need, setting up and maintaining the routine collection of PROMs/PREMs. At the consensus meeting some PROMs instruments were agreed for routine renal registry collection (the generic SF

  8. Initial Adult Health Item Banks and First Wave Testing of the Patient-Reported Outcomes Measurement Information System (PROMIS™) Network: 2005–2008

    PubMed Central

    Cella, David; Riley, William; Stone, Arthur; Rothrock, Nan; Reeve, Bryce; Yount, Susan; Amtmann, Dagmar; Bode, Rita; Buysse, Daniel; Choi, Seung; Cook, Karon; DeVellis, Robert; DeWalt, Darren; Fries, James F.; Gershon, Richard; Hahn, Elizabeth A.; Lai, Jin-Shei; Pilkonis, Paul; Revicki, Dennis; Rose, Matthias; Weinfurt, Kevin; Hays, Ron

    2010-01-01

    Objective Patient-reported outcomes (PROs) are essential when evaluating many new treatments in health care, yet current measures have been limited by a lack of precision, standardization and comparability of scores across studies and diseases. The Patient-Reported Outcomes Measurement Information System (PROMIS™) provides item banks that offer the potential for PRO measurement that is efficient (minimizes item number without compromising reliability) flexible (enables optional use of interchangeable items), and precise (has minimal error in estimate) measurement of commonly-studied PROs. We report results from the first large-scale testing of PROMIS items. Study Design and Setting Fourteen item pools were tested in the U.S. general population and clinical groups using an online panel and clinic recruitment. A scale-setting sub-sample was created reflecting demographics proportional to the 2000 U.S. census. Results Using item response theory (graded response model), 11 item banks were calibrated on a sample of 21,133, measuring components of self-reported physical, mental and social health, along with a 10-item global health scale. Short forms from each bank were developed and compared to the overall bank as well as with other well-validated and widely accepted (“legacy”) measures. All item banks demonstrated good reliability across the majority of the score distributions. Construct validity was supported by moderate to strong correlations with legacy measures. Conclusion PROMIS item banks and their short forms provide evidence they are reliable and precise measures of generic symptoms and functional reports comparable to legacy instruments. Further testing will continue to validate and test PROMIS items and banks in diverse clinical populations. PMID:20685078

  9. Patient-reported outcomes in borderline personality disorder.

    PubMed

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

    2014-06-01

    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.

  10. Patient-reported outcomes in borderline personality disorder

    PubMed Central

    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. Feasibility of Using the Patient-Reported Outcomes Measurement Information System in Academic Health Centers: Case Series Design on Pain Reduction After Chiropractic Care

    PubMed Central

    Burke, Jeanmarie R.

    2014-01-01

    Objective The purpose of this study was to test the utility of Patient-Reported Outcomes Measurement Information System (PROMIS) as a resource for collecting data on patient-reported outcomes (PRO) within academic health centers at a chiropractic college; and, to describe changes in PRO following pragmatic chiropractic care incorporating instrument-assisted soft tissue mobilization (IASTM) on pain symptoms. Methods This was a pre-post intervention design without a control group (case series) involving 25 patients (14 females and 11 males; 40.5 ± 16.39 years, range 20-70 years) who completed their chiropractic care and their baseline and post-treatment pain assessments. The pragmatic chiropractic care intervention included both spinal manipulation and IASTM to treat pain symptoms. PRO’s were collected using PROMIS to measure pain behavior, pain interference and pain intensity. Results The average pre-post assessment interval was 33 ± 22.5 days (95% CI, 23-42 days). The durations of treatments ranged from one week to 10 weeks. The median number of IASTM treatments was six. Pre-post decreases in T-scores for pain behavior and pain interference were 55.5 to 48.4 and 57.7 to 48.4, respectively (P < .05). Only 12 patients had a baseline T-score for pain intensity greater than 50. The pre-post decrease in pain intensity T-scores for these 12 patients was from 53.4 to 40.9. Conclusion Within the limitations of a case series design, these data provide initial evidence on the utility of PROMIS instruments for clinical and research outcomes in chiropractic patients. PMID:25225465

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

    PubMed Central

    El Miedany, Yasser; El Gaafary, Maha; Youssef, Sally; Ahmed, Ihab

    2016-01-01

    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. PMID:27190648

  13. [Portuguese-language cultural adaptation of the Items Banks of Anxiety and Depression of the Patient-Reported Outcomes Measurement Information System (PROMIS)].

    PubMed

    Castro, Natália Fontes Caputo de; Rezende, Carlos Henrique Alves de; Mendonça, Tânia Maria da Silva; Silva, Carlos Henrique Martins da; Pinto, Rogério de Melo Costa

    2014-04-01

    The Patient-Reported Outcome Measurement Information System (PROMIS), structured in Itens Banks, provides a new tool for evaluating results that apply to various chronic diseases through advanced statistical techniques (TRI) and computerized adaptive testing (CAT). The aim of this study was to culturally adapt the Items Banks of Anxiety and Depression of PROMIS to the Portuguese language. The process followed the recommendations of PROMIS through the advanced translation, reconciliation, back-translation, FACIT review, independent review, finalization, pre-test, and incorporation of the results from the pre-test. The translated version was pre-tested in ten patients, and items 3, 46, and 53 of the Bank of Anxiety and item 46 of the bank of Depression had to be changed. Changes affected equivalence of meaning, and the final version was consistent with the Brazilian population's linguistic and cultural skills. In conclusion, for the Brazilian population the translated version proved semantically and conceptually equivalent to the original.

  14. Patient-reported outcome measure for neuromyelitis optica: pretesting of preliminary instrument and protocol for further development in accordance with international guidelines

    PubMed Central

    Moore, P; Jackson, C; Mutch, K; Methley, A; Pollard, C; Hamid, S; Jacob, A

    2016-01-01

    Objective This study outlines the development of a patient-reported outcome measure (PROM), an instrument to obtain self-reported health status for neuromyeltis optica (NMO), a disabling neurological condition. Design Development was conducted in accordance with international guidance for PROMs including systematic review of existing literature, item generation guided by qualitative interviews, health-related quality of life conceptual framework and clinical expert panel and cognitive interviews with NMO patients. Setting Participants were identified through a national NMO clinic in a tertiary NHS neurosciences service. Participants 15 individuals with NMO participated in cognitive interviews requiring review and ranking of proposed PROM items and qualitative feedback on content, layout and response options. Results Participants endorsed the draft instrument as reflecting their experience of the condition and as being easy to understand. Rating and ranking of item relevance and importance reduced the draft instrument from 106 to 48 items. Participant feedback on overlapping items eliminated a further 2 items and resulted in a preliminary instrument of 46 items. As a direct result of participant feedback ordering of the 10 domains was revised, a 4 option Likert scale was employed and a 4-week recall period for impact of symptoms was selected. Conclusions A 46-item instrument developed in accordance with international PROM development guidelines through literature review, developed by subject matter experts and refined through pretesting examining content validity provides a preliminary measure for assessing patient-report of health status in NMO. Further evaluation is proposed including sensitivity to clinical change, and international contributions to evaluating the measure are encouraged. PMID:27694484

  15. Improving patient reported outcome measures (PROMs) in total knee replacement by changing implant and preserving the infrapatella fatpad: a quality improvement project

    PubMed Central

    Partridge, Thomas; Carluke, Ian; Emmerson, Kevin; Partington, Paul; Reed, Mike

    2016-01-01

    Patient reported outcome measures (PROMs) were introduced in 2009 to allow patient perspectives to potentially influence change and improvement. In collaboration with the national joint registry (NJR), PROMs data has been examined on a national basis to compare surgical factors in total knee replacement (TKR). Initial results demonstrated there were statistically significant differences in Oxford Knee Score (OKS) when using different brands of implant. Preservation of the infrapatella fatpad (IFP) has also been shown improve outcomes. This led Northumbria Healthcare NHS Foundation Trust to make a mass move to the Zimmer Nexgen TKR and later change surgeons' routine practice to preserving the IFP. The PROMs were recorded pre and six months post operation to obtain improvement scores. The baseline improvement in OKS was 14.0. After changing implant to the Zimmer Nexgen in Plan-Do-Study-Act (PDSA) cycle 1 the average improvement score was 16.7. After implementing default preservation of the IFP in PDSA cycle 2 the average OKS improvement score was 17.3. The results from this project demonstrate a significant improvement in local services after implementing changes based on national and local evaluations. This initiative is an excellent example of improvement by evidence based practice and success of the English National Health Service PROMs scheme. PMID:27239301

  16. Validation of the German version of the extended ALS functional rating scale as a patient-reported outcome measure.

    PubMed

    Abdulla, Susanne; Vielhaber, Stefan; Körner, Sonja; Machts, Judith; Heinze, Hans-Jochen; Dengler, Reinhard; Petri, Susanne

    2013-09-01

    The revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) is a well-established rating instrument to assess the functional status of ALS patients. A recent innovation was the addition of three further items designed to improve its sensitivity at lower levels of physical function (ALSFRS-Extension, ALSFRS-EX). Neither the ALSFRS-R nor the ALSFRS-EX has been validated in German yet. The aim of the present study was the validation of the German version of a self-administered form of the ALSFRS-EX. Seventy-six patients participated in the study. Psychometric analysis included reliability assessment and factorial analysis. To evaluate convergent validity, correlations between ALSFRS-EX items and the MRC score, spasticity, tongue movement, pulmonary function, ALSAQ-40 and Borg dyspnoea scales (upright and supine) were performed. Internal consistency as measured by Cronbach's alpha (total scale 0.868, subscales 0.690-0.938) and corrected item to total correlations (all above 0.50) was high. Test-retest reliability assessed by Spearman's rho (0.882-0.972) and Cohen's Kappa (0.63-0.92) was also high. Principal component analysis with varimax rotation yielded a four-factor solution accounting for approximately 79% of the variance. Clinical parameters were strongly correlated with respective items and subscores of the ALSFRS-EX (muscle strength 0.568-0.833 p < 0.01; spasticity -0.236 to -0.376 p < 0.05; tongue movement 0.437-0.818 p < 0.01; pulmonary function 0.485-0.577 p < 0.01). ALSAQ-40 and Borg score correlated highly with the corresponding ALSFRS-EX items. The German self-report version of the ALSFRS-EX possesses very good psychometric properties similar to the original scale including high internal consistency and test-retest reliability as well as excellent convergent validity.

  17. Prevalence of Pain and Analgesic Use in Men With Metastatic Prostate Cancer Using a Patient-Reported Outcome Measure

    PubMed Central

    Autio, Karen A.; Bennett, Antonia V.; Jia, Xiaoyu; Fruscione, Michael; Beer, Tomasz M.; George, Daniel J.; Carducci, Michael A.; Logothetis, Christopher J.; Kane, Robert C.; Sit, Laura; Rogak, Lauren; Morris, Michael J.; Scher, Howard I.; Basch, Ethan M.

    2013-01-01

    Purpose: Contemporary tumor-directed therapies for metastatic castration-resistant prostate cancer (mCRPC) are approved to prolong life, but their effects on symptoms such as pain are less well understood as a result of the lack of analytically valid assessments of pain prevalence and severity, clinically meaningful definitions of therapeutic benefit, and methodologic standards of trial conduct. This study establishes pain characteristics in the mCRPC population using a PRO measure. Materials and Methods: Patients with prostate cancer participated in an anonymous survey at five US comprehensive cancer centers in the Prostate Cancer Clinical Trials Consortium that incorporated the Brief Pain Inventory (BPI), analgesic use, and interference with daily activities. Prevalence and severity of cancer-related pain and analgesic use were tabulated according to castration-resistant status and exposure to docetaxel chemotherapy. Results: Four hundred sixty-one patients with prostate cancer participated, of whom 147 had mCRPC involving bone (61% [89 of 147] docetaxel exposed, 39% [58 of 147] docetaxel naive). Pain of any level was more common among docetaxel-exposed versus docetaxel-naive patients with mCRPC (70% [62 of 89] v 38% [22 of 58], respectively; P < .001). BPI score ≥ 4 was reported by 38% (34 of 89) of docetaxel-pretreated and 24% (14 of 58) of docetaxel-naive patients with mCRPC; 40% of these patients with pain intensity ≥ 4 reported no current narcotic analgesic. Conclusion: Pain prevalence and severity were higher in patients with prior docetaxel exposure. Analgesics were underutilized. These results provide a method for estimating accruals along the disease continuum, and for enabling design of trials appropriately powered to assess pain. PMID:23943897

  18. Mapping the Content of the Patient Reported Outcomes Measurement Information System (PROMIS®) Using the International Classification of Functioning, Health and Disability

    PubMed Central

    Tucker, Carole A; Escorpizo, Reuben; Cieza, Alarcos; Lai, Jin Shei; Stucki, Gerold; Ustun, T. Bedirhan; Kostanjsek, Nenad; Cella, David; Forrest, Christopher B.

    2014-01-01

    Background The Patient Reported Outcomes Measurement Information System (PROMIS®) is a U.S. National Institutes of Health initiative that has produced self-reported item banks for physical, mental, and social health. Objective To describe the content of PROMIS at the item level using the World Health Organization’s International Classification of Functioning, Disability and Health (ICF). Methods All PROMIS adult items (publicly available as of 2012) were assigned to relevant ICF concepts. The content of the PROMIS adult item banks were then described using the mapped ICF code descriptors. Results The 1006 items in the PROMIS instruments could all be mapped to ICF concepts at the second level of classification, with the exception of 3 items of global or general health that mapped across the first-level classification of ICF activity and participation component (d categories). Individual PROMIS item banks mapped from 1 to 5 separate ICF codes indicating one-to-one, one-to-many and many-to-one mappings between PROMIS item banks and ICF second level classification codes. PROMIS supports measurement of the majority of major concepts in the ICF Body Functions (b) and Activity & Participation (d) components using PROMIS item banks or subsets of PROMIS items that could, with care, be used to develop customized instruments. Given the focus of PROMIS is on measurement of person health outcomes, concepts in body structures (s) and some body functions (b), as well as many ICF environmental factor have minimal coverage in PROMIS. Discussion The PROMIS-ICF mapped items provide a basis for users to evaluate the ICF related content of specific PROMIS instruments, and to select PROMIS instruments in ICF based measurement applications. PMID:24760532

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

    SciTech Connect

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

    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.

  20. Capturing Patient-Reported Outcome (PRO) Data Electronically: The Past, Present, and Promise of ePRO Measurement in Clinical Trials.

    PubMed

    Coons, Stephen Joel; Eremenco, Sonya; Lundy, J Jason; O'Donohoe, Paul; O'Gorman, Hannah; Malizia, William

    2015-08-01

    Patient-reported outcomes (PROs) are an important means of evaluating the treatment benefit of new medical products. It is recognized that PRO measures should be used when assessing concepts best known by the patient or best measured from the patient's perspective. As a result, there is growing emphasis on well defined and reliable PRO measures. In addition, advances in technology have significantly increased electronic PRO (ePRO) data collection capabilities and options in clinical trials. The movement from paper-based to ePRO data capture has enhanced the integrity and accuracy of clinical trial data and is encouraged by regulators. A primary distinction in the types of ePRO platforms is between telephone-based interactive voice response systems and screen-based systems. Handheld touchscreen-based devices have become the mainstay for remote (i.e., off-site, unsupervised) PRO data collection in clinical trials. The conventional approach is to provide study subjects with a handheld device with a device-based proprietary software program. However, an emerging alternative for clinical trials is called bring your own device (BYOD). Leveraging study subjects' own Internet-enabled mobile devices for remote PRO data collection (via a downloadable app or a Web-based data collection portal) has become possible due to the widespread use of personal smartphones and tablets. However, there are a number of scientific and operational issues that must be addressed before BYOD can be routinely considered as a practical alternative to conventional ePRO data collection methods. Nevertheless, the future for ePRO data collection is bright and the promise of BYOD opens a new chapter in its evolution.

  1. Assessing severity of illness and outcomes of treatment in children with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME): a systematic review of patient-reported outcome measures (PROMs).

    PubMed

    Haywood, K L; Collin, S M; Crawley, E

    2014-11-01

    Chronic Fatigue Syndrome or Myalgic Encephalomyelitis (CFS/ME) in children is characterized by persistent or recurrent debilitating fatigue which results in a substantial reduction in activity. There is a growing interest in the use of questionnaires, or patient-reported outcome measures (PROMs), to assess how patients function and feel in relation to their health and associated healthcare. However, guidance for PROM selection for children with CFS/ME does not exist. We reviewed the quality and acceptability of PROMs used with children with CFS/ME to inform recommendations for practice. We conducted a systematic review of PROMs completed by children with CFS/ME. The quality of the evaluative studies and the reviewed measures were assessed against recommended criteria using an appraisal framework and the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. We sought evidence of measurement (reliability, validity, responsiveness, interpretability, data quality) and practical properties (acceptability, relevance, feasibility). Sixteen articles were included in the review, providing evidence of reliability and/or validity for 13 PROMs. Of these, five were child-specific (one health-related quality-of-life; four emotional well-being) and eight were not (four emotional well-being, three fatigue-specific; and one generic). All measures had limited evidence of measurement properties and no evidence of practical properties. Recommendations for patient-reported assessment are difficult to make because of limited evidence of the quality and acceptability of PROMs for children with CFS/ME. The appraisal method highlighted significant methodological and quality issues which must be addressed in future research. There is a lack of qualitative evidence describing the outcomes of healthcare that are important to children with CFS/ME, and the relevance or appropriateness of available measures. Future PROM development and evaluation in

  2. [Patient-reported and patient-weighted outcomes in ophthalmology].

    PubMed

    Scheibler, F; Finger, R P; Grosselfinger, R; Dintsios, C-M

    2010-03-01

    Considering patients' values and preferences in comparative effectiveness research (CER) is one of the main challenges in ophthalmology (value-based medicine). This article defines core terms in CER. The concept of patient-relevant (or patient-important) outcomes is distinguished from patient-reported outcomes (PRO) by means of examples in the field of ophthalmology. In order to be able to give a consistant recommendation if an intervention leads to conflicting results for different outcomes (trade-off), a ranking of outcomes will be necessary. Examples of studies in glaucoma patients are provided that demonstrate the possibilities of ranking of outcomes based on patient preferences. PMID:20024566

  3. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation.

    PubMed

    Wild, Diane; Grove, Alyson; Martin, Mona; Eremenco, Sonya; McElroy, Sandra; Verjee-Lorenz, Aneesa; Erikson, Pennifer

    2005-01-01

    In 1999, ISPOR formed the Quality of Life Special Interest group (QoL-SIG)--Translation and Cultural Adaptation group (TCA group) to stimulate discussion on and create guidelines and standards for the translation and cultural adaptation of patient-reported outcome (PRO) measures. After identifying a general lack of consistency in current methods and published guidelines, the TCA group saw a need to develop a holistic perspective that synthesized the full spectrum of published methods. This process resulted in the development of Translation and Cultural Adaptation of Patient Reported Outcomes Measures--Principles of Good Practice (PGP), a report on current methods, and an appraisal of their strengths and weaknesses. The TCA Group undertook a review of evidence from current practice, a review of the literature and existing guidelines, and consideration of the issues facing the pharmaceutical industry, regulators, and the broader outcomes research community. Each approach to translation and cultural adaptation was considered systematically in terms of rationale, components, key actors, and the potential benefits and risks associated with each approach and step. The results of this review were subjected to discussion and challenge within the TCA group, as well as consultation with the outcomes research community at large. Through this review, a consensus emerged on a broad approach, along with a detailed critique of the strengths and weaknesses of the differing methodologies. The results of this review are set out as "Translation and Cultural Adaptation of Patient Reported Outcomes Measures--Principles of Good Practice" and are reported in this document.

  4. 'The patient': at the center of patient-reported outcomes.

    PubMed

    Awad, A George

    2015-01-01

    The recent emphasis of including patient reports in their own care management is reviewed in terms of the factors that contributed to its popularity. The role change of patients as being active participants in their own care as a result of the rising consumerism and advocacy has led to increased pressures for including patients in the therapeutic decision-making process. As consumers of clinical services, their perspectives and attitudes towards health and illness acquired more importance. The rising cost of healthcare has added another dimension in cost containment by empowering patients and sharing responsibility in their recovery, which hopefully can improve outcomes. Challenges in the development and implementation of patient-reported outcomes in psychiatry are reviewed and include the still unresolved subjective/objective dichotomy, identification of the most appropriate and relevant patient-reported outcomes. Few outcomes are identified and include: subjective tolerability of medication, self-reported health-related quality of life, preferences, patients' attitudes towards health and illness, satisfaction with medication and overall satisfaction of quality of care, and functional state, with particular focus on social functioning. PMID:26289737

  5. Yoga & cancer interventions: a review of the clinical significance of patient reported outcomes for cancer survivors.

    PubMed

    Culos-Reed, S Nicole; Mackenzie, Michael J; Sohl, Stephanie J; Jesse, Michelle T; Zahavich, Ashley N Ross; Danhauer, Suzanne C

    2012-01-01

    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. PMID:23125870

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

    PubMed Central

    Culos-Reed, S. Nicole; Mackenzie, Michael J.; Sohl, Stephanie J.; Jesse, Michelle T.; Zahavich, Ashley N. Ross; Danhauer, Suzanne C.

    2012-01-01

    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. PMID:23125870

  7. Patient-reported outcomes in studies of complementary and alternative medicine: problems, solutions, and future directions.

    PubMed

    Eton, David T; Bauer, Brent A; Sood, Amit; Yost, Kathleen J; Sloan, Jeff A

    2011-01-01

    Patient-reported outcome (PRO) measures are frequently used to assess therapeutic efficacy and effectiveness of complementary and alternative medicine (CAM). Although CAM investigators are increasingly making use of valid, self-report instruments to assess patient-relevant outcomes, the sheer number of available instruments poses challenges. Two of the more pressing issues are discussed: the lack of guidance for selecting measures and the limited attention paid to the clinical meaningfulness of PRO results. Solutions are offered that may support selection and standardization of outcome measures for future CAM studies. This includes testing of tools from the National Institutes of Health's Patient-Reported Outcomes Measurement Information System (PROMIS). Increased standardization of outcome measurement in CAM studies will allow for more cross-study comparisons and facilitate the statistical pooling of results, ultimately leading to a more informative evidence base.

  8. Capturing and Incorporating Patient-Reported Outcomes into Clinical Trials: Practical Considerations for Clinicians.

    PubMed

    Botero, Juliana Perez; Thanarajasingam, Gita; Warsame, Rahma

    2016-10-01

    Patient centeredness as the focus of healthcare delivery requires the incorporation of patient-reported outcomes into clinical trials. Clearly defining measurable outcomes as well as selecting the most appropriate validated collection tool to use is imperative for success. Creating and validating one's own instrument is also possible, albeit more cumbersome. Meticulous data collection to avoid missing data is key, as is limiting the number of data collection points to prevent survey fatigue and using electronic systems to facilitate data gathering and analysis. Working in a multidisciplinary team that includes statisticians with expertise in patient reported outcomes is essential to navigate the complexities of statistical analysis of these variables. Use of available and emerging technologies for data collection and analysis as well as data sharing will greatly facilitate the process of incorporating patient-reported outcomes into trials and routine clinical practice. PMID:27525737

  9. Mediators of Atherosclerosis in South Asians Living in America: Use of Web-Based Methods for Follow-Up and Collection of Patient-Reported Outcome Measures

    PubMed Central

    Puri-Taneja, Ankita; Victorson, David E; Dave, Swapna S; Kanaya, Alka M; Huffman, Mark D

    2016-01-01

    Background A key challenge for longitudinal cohort studies is follow-up and retention of study participants. Participant follow-up in longitudinal cohort studies is costly and time-consuming for research staff and participants. Objective This study determined the feasibility and costs of using Web-based technologies for follow-up and collection of patient-reported outcomes in the Mediators of Atherosclerosis in South Asians Living in America (MASALA) study. Methods The MASALA study is a community-based cohort of 906 South Asians in the United States. Since the baseline in-person visits (2010-2013), a yearly telephone follow-up survey was used to assess participants’ health status and incidence of cardiovascular disease. A Web-based version of the follow-up survey was developed using the REDCap (Research Electronic Data Capture) Web app. Participants from the Chicago field center who were due for their annual follow-up and who had a valid email address were sent an email link to a secure online portal where they could complete the survey. Telephone follow-up was used with nonresponders. Results A link to the Web survey was emailed to 285 participants (February to October 2014) and the overall completion rate was 47.7% (136/285). One-third of participants who were unresponsive (n=36) to annual telephone follow-up completed the Web survey. Web responders were younger, more likely to be married, and to have higher education and income compared (P<.05) to telephone-only responders. Web survey development involved 240 hours of research staff time. Since launching, the Web-based survey has required 3 hours per week of staff time. Conclusions Although electronic follow-up will not be a panacea for cohort operations, it will serve as an adjunctive strategy to telephonic follow-up for maximizing cohort retention with lower costs. PMID:27278905

  10. Athletic groin pain (part 1): a prospective anatomical diagnosis of 382 patients—clinical findings, MRI findings and patient-reported outcome measures at baseline

    PubMed Central

    Falvey, É C; King, E; Kinsella, S; Franklyn-Miller, A

    2016-01-01

    Background Athletic groin pain remains a common field-based team sports time-loss injury. There are few reports of non-surgically managed cohorts with athletic groin pain. Aim To describe clinical presentation/examination, MRI findings and patient-reported outcome (PRO) scores for an athletic groin pain cohort. Methods All patients had a history including demographics, injury duration, sport played and standardised clinical examination. All patients underwent MRI and PRO score to assess recovery. A clinical diagnosis of the injured anatomical structure was made based on these findings. Statistical assessment of the reliability of accepted standard investigations undertaken in making an anatomical diagnosis was performed. Result 382 consecutive athletic groin pain patients, all male, enrolled. Median time in pain at presentation was (IQR) 36 (16–75) weeks. Most (91%) played field-based ball-sports. Injury to the pubic aponeurosis (PA) 240 (62.8%) was the most common diagnosis. This was followed by injuries to the hip in 81 (21.2%) and adductors in 56 (14.7%) cases. The adductor squeeze test (90° hip flexion) was sensitive (85.4%) but not specific for the pubic aponeurosis and adductor pathology (negative likelihood ratio 1.95). Analysed in series, positive MRI findings and tenderness of the pubic aponeurosis had a 92.8% post-test probability. Conclusions In this largest cohort of patients with athletic groin pain combining clinical and MRI diagnostics there was a 63% prevalence of PA injury. The adductor squeeze test was sensitive for athletic groin pain, but not specific individual pathologies. MRI improved diagnostic post-test probability. No hernia or incipient hernia was diagnosed. Clinical trial registration number NCT02437942. PMID:26626272

  11. Sleep-Wake Functioning Along the Cancer Continuum: Focus Group Results From the Patient-Reported Outcomes Measurement Information System (PROMIS™)

    PubMed Central

    Flynn, Kathryn E.; Shelby, Rebecca A.; Mitchell, Sandra A.; Fawzy, Maria R.; Hardy, N. Chantelle; Husain, Aatif M.; Keefe, Francis J.; Krystal, Andrew D.; Porter, Laura S.; Reeve, Bryce B.; Weinfurt, Kevin P.

    2009-01-01

    Objective Cancer and its treatments disturb sleep-wake functioning; however, there is little information available on the characteristics and consequences of sleep problems associated with cancer. As part of an effort to improve measurement of sleep-wake functioning, we explored the scope of difficulties with sleep in a diverse group of patients diagnosed with cancer. Methods We conducted 10 focus groups with patients recruited from the Duke University tumor registry and oncology/hematology clinics. Separate groups were held with patients scheduled to begin or currently undergoing treatment for breast, prostate, lung, colorectal, hematological, and other cancer types and with patients who were in posttreatment follow-up. The content of the focus group discussions was transcribed and analyzed for major themes by independent coders. Results Participants reported causes of sleep disturbance common in other populations, such as pain and restless legs, but they also reported causes that may be unique to cancer populations, including abnormal dreams, anxiety about cancer diagnosis and recurrence, night sweats, and problems with sleep positioning. Many participants felt that sleep problems reduced their productivity, concentration, social interactions, and overall quality of life. Many also shared beliefs about the increased importance of sleep when fighting cancer. Conclusions The findings underscore the need for interventions that minimize the negative impact of cancer and its treatments on sleep. This study will inform efforts now underway to develop a patient-reported measure of sleep-wake functioning that reflects the breadth of concepts considered important by patients with cancer. PMID:20013938

  12. Determining the non-inferiority margin for patient reported outcomes.

    PubMed

    Gerlinger, Christoph; Schmelter, Thomas

    2011-01-01

    One of the cornerstones of any non-inferiority trial is the choice of the non-inferiority margin delta. This threshold of clinical relevance is very difficult to determine, and in practice, delta is often "negotiated" between the sponsor of the trial and the regulatory agencies. However, for patient reported, or more precisely patient observed outcomes, the patients' minimal clinically important difference (MCID) can be determined empirically by relating the treatment effect, for example, a change on a 100-mm visual analogue scale, to the patient's satisfaction with the change. This MCID can then be used to define delta. We used an anchor-based approach with non-parametric discriminant analysis and ROC analysis and a distribution-based approach with Norman's half standard deviation rule to determine delta in three examples endometriosis-related pelvic pain measured on a 100-mm visual analogue scale, facial acne measured by lesion counts, and hot flush counts. For each of these examples, all three methods yielded quite similar results. In two of the cases, the empirically derived MCIDs were smaller or similar of deltas used before in non-inferiority trials, and in the third case, the empirically derived MCID was used to derive a responder definition that was accepted by the FDA. In conclusion, for patient-observed endpoints, the delta can be derived empirically. In our view, this is a better approach than that of asking the clinician for a "nice round number" for delta, such as 10, 50%, π, e, or i. PMID:21932298

  13. Patient-Reported Outcome Measures (PROMS) in patients undergoing heart valve surgery: why should we measure them and which instruments should we use?

    PubMed Central

    Holmes, Charlotte; Briffa, Norman

    2016-01-01

    Objective As the population ages, the incidence of heart valve disease (HVD) is increasing. The aim of treatment is to improve prognosis and quality of life. Standard surgical treatment is being superseded by new catheter-based treatments, many of which are as yet unproven. The need for appropriate instruments to measure quality of life in patients receiving treatment for HVD has therefore never been greater. Methods In this prospective observational study, a generic instrument, Euroqol, and a disease-specific one (Minnesota Living with Heart Failure Questionnaire—MLHFQ) were, for the first time, formally tested before and after surgery in 84 patients with HVD who completed their treatment. Patients were interviewed on the night before surgery and 6–12 weeks after being discharged. Instruments were tested for validity, reliability, responsiveness, sensitivity and interpretability. Results Both Euroqol and MLHFQ registered significant improvements in patients' health. Tests for validity were significantly positive for both Euroqol and MLHFQ. Tests for reliability and responsiveness were very positive for MLHFQ, less so for EQ-5D. There was a moderate ceiling effect in the postoperative Index scores of Euroqol and a moderate floor effect in MLHFQ. Conclusions Both instruments together performed very well in assessing the health of patients undergoing surgical treatment of HVD. As the incidence of HVD increases and therapeutic options increase, measurement of PROMS using these two instruments should become a matter of routine. PMID:27175284

  14. Outcome Measure Development.

    PubMed

    Mohtadi, Nicholas G

    2016-01-01

    Measuring patient-reported outcomes is the current method for conducting clinical research. Creating a new outcome measure is an exhaustive process that should be carefully monitored and concentrated on only important and common conditions. The evaluation of an existing outcome measure should involve assessing its internal consistency, reliability, floor and ceiling effects, validity, and ability to measure clinically meaningful change. The most important characteristic of a patient-reported outcome is that it is developed with direct input from its target patient population. Item generation and reduction is the most critical step in the development process because it "guarantees" that patients have communicated what is important to them and represents content validity. Outcome measures should not change; rather, they should demonstrate responsiveness by being reproducible and reliable if a patient's clinical condition is stable or reflect differences if a patient's clinical condition varies. Validation is an iterative process and requires patients from different settings and circumstances. PMID:27049222

  15. The Importance of Hand Appearance as a Patient-Reported Outcome in Hand Surgery

    PubMed Central

    Johnson, Shepard P.; Sebastin, Sandeep J.; Rehim, Shady A.

    2015-01-01

    Summary: Hand appearance is meaningful to patients because hands are an essential part of human interactions, communication, and social integration. Recent literature indicates that hand aesthetics is an important, measurable patient-reported outcome. In hand surgery, several outcome instruments exist that accurately measure functional outcomes, but aesthetics is often overlooked or imprecisely measured. This makes comparison of disease burden and effectiveness of therapies, as they pertain to aesthetics, difficult. This special topic article outlines the aesthetic features of the hand, how literature is evaluating the appearance of the hand in outcomes research, and proposes a novel approach to assessing hand aesthetics. PMID:26893977

  16. Is Real-Time Feedback of Burn-Specific Patient-Reported Outcome Measures in Clinical Settings Practical and Useful? A Pilot Study Implementing the Young Adult Burn Outcome Questionnaire.

    PubMed

    Ryan, Colleen M; Lee, Austin F; Kazis, Lewis E; Shapiro, Gabriel D; Schneider, Jeffrey C; Goverman, Jeremy; Fagan, Shawn P; Wang, Chao; Kim, Julia; Sheridan, Robert L; Tompkins, Ronald G

    2016-01-01

    Long-term follow-up care of survivors after burn injuries can potentially be improved by the application of patient-reported outcome measures (PROMs). PROMs can inform clinical decision-making and foster communication between the patient and provider. There are no previous reports using real-time, burn-specific PROMs in clinical practice to track and benchmark burn recovery over time. This study examines the feasibility of a computerized, burn-specific PROM, the Young Adult Burn Outcome Questionnaire (YABOQ), with real-time benchmarking feedback in a burn outpatient practice. The YABOQ was redesigned for formatting and presentation purposes using images and transcribed to a computerized format. The redesigned questionnaire was administered to young adult burn survivors (ages 19-30 years, 1-24 months from injury) via an ipad platform in the office before outpatient visits. A report including recovery curves benchmarked to a nonburned relatively healthy age-matched population and to patients with similar injuries was produced for the domains of physical function and social function limited by appearance. A copy of the domain reports as well as a complete copy of the patient's responses to all domain questions was provided for use during the clinical visit. Patients and clinicians completed satisfaction surveys at the conclusion of the visit. Free-text responses, included in the satisfaction surveys, were treated as qualitative data adding contextual information about the assessment of feasibility. Eleven patients and their providers completed the study for 12 clinical visits. All patients found the ipad survey and report "easy" or "very easy" to use. In nine instances, patients "agreed" or "strongly agreed" that it helped them communicate their situation to their doctor/nurse practitioner. Patients "agreed" or "strongly agreed" that the report helped them understand their course of recovery in 10 visits. In 11 visits, the patients "agreed" or "strongly agreed" that

  17. Is Real-Time Feedback of Burn-Specific Patient-Reported Outcome Measures in Clinical Settings Practical and Useful? A Pilot Study Implementing the Young Adult Burn Outcome Questionnaire.

    PubMed

    Ryan, Colleen M; Lee, Austin F; Kazis, Lewis E; Shapiro, Gabriel D; Schneider, Jeffrey C; Goverman, Jeremy; Fagan, Shawn P; Wang, Chao; Kim, Julia; Sheridan, Robert L; Tompkins, Ronald G

    2016-01-01

    Long-term follow-up care of survivors after burn injuries can potentially be improved by the application of patient-reported outcome measures (PROMs). PROMs can inform clinical decision-making and foster communication between the patient and provider. There are no previous reports using real-time, burn-specific PROMs in clinical practice to track and benchmark burn recovery over time. This study examines the feasibility of a computerized, burn-specific PROM, the Young Adult Burn Outcome Questionnaire (YABOQ), with real-time benchmarking feedback in a burn outpatient practice. The YABOQ was redesigned for formatting and presentation purposes using images and transcribed to a computerized format. The redesigned questionnaire was administered to young adult burn survivors (ages 19-30 years, 1-24 months from injury) via an ipad platform in the office before outpatient visits. A report including recovery curves benchmarked to a nonburned relatively healthy age-matched population and to patients with similar injuries was produced for the domains of physical function and social function limited by appearance. A copy of the domain reports as well as a complete copy of the patient's responses to all domain questions was provided for use during the clinical visit. Patients and clinicians completed satisfaction surveys at the conclusion of the visit. Free-text responses, included in the satisfaction surveys, were treated as qualitative data adding contextual information about the assessment of feasibility. Eleven patients and their providers completed the study for 12 clinical visits. All patients found the ipad survey and report "easy" or "very easy" to use. In nine instances, patients "agreed" or "strongly agreed" that it helped them communicate their situation to their doctor/nurse practitioner. Patients "agreed" or "strongly agreed" that the report helped them understand their course of recovery in 10 visits. In 11 visits, the patients "agreed" or "strongly agreed" that

  18. A randomized controlled trial of patient-reported outcomes with tai chi exercise in Parkinson's disease.

    PubMed

    Li, Fuzhong; Harmer, Peter; Liu, Yu; Eckstrom, Elizabeth; Fitzgerald, Kathleen; Stock, Ronald; Chou, Li-Shan

    2014-04-01

    A previous randomized, controlled trial of tai chi showed improvements in objectively measured balance and other motor-related outcomes in patients with Parkinson's disease. This study evaluated whether patient-reported outcomes could be improved through exercise interventions and whether improvements were associated with clinical outcomes and exercise adherence. In a secondary analysis of the tai chi trial, patient-reported and clinical outcomes and exercise adherence measures were compared between tai chi and resistance training and between tai chi and stretching exercise. Patient-reported outcome measures were perceptions of health-related benefits resulting from participation, assessed by the Parkinson's Disease Questionnaire (PDQ-8) and Vitality Plus Scale (VPS). Clinical outcome measures included motor symptoms, assessed by a modified Unified Parkinson's Disease Rating Scale-Motor Examination (UPDRS-ME) and a 50-foot speed walk. Information on continuing exercise after the structured interventions were terminated was obtained at a 3-month postintervention follow-up. Tai chi participants reported significantly better improvement in the PDQ-8 (-5.77 points, P = 0.014) than did resistance training participants and in PDQ-8 (-9.56 points, P < 0.001) and VPS (2.80 points, P = 0.003) than did stretching participants. For tai chi, patient-reported improvement in the PDQ-8 and VPS was significantly correlated with their clinical outcomes of UPDRS-ME and a 50-foot walk, but these correlations were not statistically different from those shown for resistance training or stretching. However, patient-reported outcomes from tai chi training were associated with greater probability of continued exercise behavior than were either clinical outcomes or patient-reported outcomes from resistance training or stretching. Tai chi improved patient-reported perceptions of health-related benefits, which were found to be associated with a greater probability of exercise

  19. A Randomized Controlled Trial of Patient-Reported Outcomes With Tai Chi Exercise in Parkinson's Disease

    PubMed Central

    Li, Fuzhong; Harmer, Peter; Liu, Yu; Eckstrom, Elizabeth; Fitzgerald, Kathleen; Stock, Ronald; Chou, Li-Shan

    2014-01-01

    A previous randomized, controlled trial of tai chi showed improvements in objectively measured balance and other motor-related outcomes in patients with Parkinson's disease. This study evaluated whether patient-reported outcomes could be improved through exercise interventions and whether improvements were associated with clinical outcomes and exercise adherence. In a secondary analysis of the tai chi trial, patient-reported and clinical outcomes and exercise adherence measures were compared between tai chi and resistance training and between tai chi and stretching exercise. Patient-reported outcome measures were perceptions of health-related benefits resulting from participation, assessed by the Parkinson's Disease Questionnaire (PDQ-8) and Vitality Plus Scale (VPS). Clinical outcome measures included motor symptoms, assessed by a modified Unified Parkinson's Disease Rating Scale–Motor Examination (UPDRS-ME) and a 50-foot speed walk. Information on continuing exercise after the structured interventions were terminated was obtained at a 3-month postintervention follow-up. Tai chi participants reported significantly better improvement in the PDQ-8 (−5.77 points, P = 0.014) than did resistance training participants and in PDQ-8 (−9.56 points, P < 0.001) and VPS (2.80 points, P = 0.003) than did stretching participants. For tai chi, patient-reported improvement in the PDQ-8 and VPS was significantly correlated with their clinical outcomes of UPDRS-ME and a 50-foot walk, but these correlations were not statistically different from those shown for resistance training or stretching. However, patient-reported outcomes from tai chi training were associated with greater probability of continued exercise behavior than were either clinical outcomes or patient-reported outcomes from resistance training or stretching. Tai chi improved patient-reported perceptions of health-related benefits, which were found to be associated with a greater probability of exercise

  20. Electronic patient-reported outcome systems in oncology clinical practice.

    PubMed

    Bennett, Antonia V; Jensen, Roxanne E; Basch, Ethan

    2012-01-01

    Patient-reported outcome (PRO) questionnaires assess topics a patient can report about his or her own health. This includes symptoms (eg, nausea, fatigue, diarrhea, pain, or frequent urination), physical functioning (eg, difficulty climbing stairs or difficulty fastening buttons), and mental health (eg, anxiety, fear, or worry). Electronic PRO (ePRO) systems are used in oncology clinical care because of 1) their ability to enhance clinical care by flagging important symptoms and saving clinicians time; 2) the availability of standardized methods for creating and implementing PROs in clinics; and 3) the existence of user-friendly platforms for patient self-reporting like tablet computers and automated telephone surveys. Many ePRO systems can provide actionable links to clinical care such as summary reports in a patient's electronic medical record and real-time e-mail alerts to providers when patients report acute needs. This review presents 5 examples of ePRO systems currently in use in oncology practice. These systems support multiple clinical activities, including assessment of symptoms and toxicities related to chemotherapy and radiation, postoperative surveillance, and symptom management during palliative care and hospice. Patient self-reporting is possible both at clinical visits and between visits over the Internet or by telephone. The implementation of an ePRO system requires significant resources and expertise, as well as user training. ePRO systems enable regular monitoring of patient symptoms, function, and needs, and can enhance the efficiency and quality of care as well as communication with patients.

  1. Application of Bother in patient reported outcomes instruments across cultures

    PubMed Central

    2014-01-01

    Background The objective of this study was to determine the applicability of the term bother, as used in Patient Reported Outcomes (PRO) instruments that will be translated into foreign languages from English for the United States. Bother is versatile in English for the U.S., in that it can describe negative mental states and physical sensations, as well as social disturbances. Bother has many different meanings across cultures, due to this versatility. Alternatives for bother were explored for future PRO instrument development. Methods A PRO instrument used to evaluate the degree of bother resulting from psoriasis was analyzed. This disease can negatively impact patients physically, emotionally and socially. Translations of bother were analyzed to determine its meaning when translated into other languages. Cognitive debriefing was conducted on psoriasis patients with the instrument containing bother. Following cognitive debriefing, a questionnaire was distributed to linguists and cognitive debriefing subjects to collect definitions of bother in each target language, and detail any difficulty with translation. To establish alternatives to bother and demonstrate the breakdown of concepts within bother, translations of the Dermatology Quality of Life Index (DLQI) were analyzed. This instrument was selected for its focus on psoriasis and use of terminology that lacks the ambiguity of bother. Results An analysis of back-translations revealed that bother yielded a back-translation that was conceptually different from the source 20% of the time (5/26). Analysis of alternative terminology found in the DLQI revealed much greater conceptual equivalence when translated into other languages. Conclusion When developing the wording of PRO instruments, the terminology chosen should be applicable across languages to allow for international pooling and comparison of data. While all linguists and subjects of cognitive debriefing understood bother to have a negative connotation, a

  2. Evaluating and Quantifying User and Carer Involvement in Mental Health Care Planning (EQUIP): Co-Development of a New Patient-Reported Outcome Measure

    PubMed Central

    2016-01-01

    International and national health policy seeks to increase service user and carer involvement in mental health care planning, but suitable user-centred tools to assess the success of these initiatives are not yet available. The current study describes the development of a new reliable and valid, interval-scaled service-user and carer reported outcome measure for quantifying user/carer involvement in mental health care planning. Psychometric development reduced a 70-item item bank to a short form questionnaire using a combination of Classical Test, Mokken and Rasch Analyses. Test-retest reliability was calculated using t-tests of interval level scores between baseline and 2–4 week follow-up. Items were worded to be relevant to both service users and carers. Nine items were removed following cognitive debriefing with a service user and carer advisory group. An iterative process of item removal reduced the remaining 61 items to a final 14-item scale. The final scale has acceptable scalability (Ho = .69), reliability (alpha = .92), fit to the Rasch model (χ2(70) = 97.25, p = .02), and no differential item functioning or locally dependent items. Scores remained stable over the 4 week follow-up period, indicating good test-retest reliability. The ‘Evaluating the Quality of User and Carer Involvement in Care Planning (EQUIP)’ scale displays excellent psychometric properties and is capable of unidimensional linear measurement. The scale is short, user and carer-centred and will be of direct benefit to clinicians, services, auditors and researchers wishing to quantify levels of user and carer involvement in care planning. PMID:26963252

  3. Patient reported outcomes in the assessment of premature ejaculation.

    PubMed

    Althof, Stanley E

    2016-08-01

    The term 'Patient Reported Outcome', abbreviated as PRO, was introduced by the US Food and Drug Administration (FDA) which proposed guidance on the development and validation of PROs. Previously PROs were known as self-report diaries, event-logs, self-administered questionnaires, and clinician administered rating scales. PROs seek to capture the subjective perceptions of patients and/or partner's related to their specific symptoms, degree of bother, efficacy of a medication or psychotherapy intervention, and quality of life issues related to a specific condition. This article reviews the essential psychometric and regulatory agency requirements in the development of PROs. The constructs of reliability, various forms of validity, sensitivity, and specificity as well as concerns with translating a PRO into a different language are reviewed. Three PROs, the Premature Ejaculation Profile (PEP), the Index of Premature Ejaculation (IPE) and the Premature Ejaculation Diagnostic Tool (PEDT) all used in the assessment of premature ejaculation (PE) are discussed. These questionnaires meet or exceed all the psychometric requirements and have been employed in clinical trials and observational studies of men with PE. The article concludes on discussing some of the limitations of PRO use and recommendations for the future. PMID:27652219

  4. Designing of Intelligent Multilingual Patient Reported Outcome System (IMPROS)

    PubMed Central

    Pourasghar, Faramarz; Partovi, Yeganeh

    2015-01-01

    Background: By self-reporting outcome procedure the patients themselves record disease symptoms outside medical centers and then report them to medical staff in specific periods of time. One of the self-reporting methods is the application of interactive voice response (IVR), in which some pre-designed questions in the form of voice tracks would be played and then the caller responses the questions by pressing phone’s keypad bottoms. Aim: The present research explains the main framework of such system designing according to IVR technology that is for the first time designed and administered in Iran. Methods: Interactive Voice Response system was composed by two main parts of hardware and software. Hardware section includes one or several digital phone lines, a modem card with voice playing capability and a PC. IVR software on the other hand, acts as an intelligent control center, records call information and controls incoming data. Results: One of the main features of the system is its capability to be administered in common PCs, utilizing simple and cheap modems, high speed to take responses and it’s appropriateness to low literate patients. The system is applicable for monitoring chronic diseases, cancer and also in psychological diseases and can be suitable for taking care of elders and Children who require long term cares. Other features include user-friendly, decrease in direct and indirect costs of disease treatment and enjoying from high level of security to access patients’ profiles. Conclusions: Intelligent multilingual patient reported outcome system (IMPROS) by controlling diseases gives the opportunity to patients to have more participation during treatment and it improves mutual interaction between patient and medical staff. Moreover it increases the quality of medical services, Additional to empowering patients and their followers. PMID:26635441

  5. Comparison of Provider-Assessed and Patient-Reported Outcome Measures of Acute Skin Toxicity During a Phase III Trial of Mometasone Cream Versus Placebo During Breast Radiotherapy: The North Central Cancer Treatment Group (N06C4)

    SciTech Connect

    Neben-Wittich, Michelle A.; Atherton, Pamela J.; Schwartz, David J.; Sloan, Jeff A.; Griffin, Patricia C.; Deming, Richard L.; Anders, Jon C.; Loprinzi, Charles L.; Burger, Kelli N.; Martenson, James A.; Miller, Robert C.

    2011-10-01

    Purpose: Considerable interobserver variability exists among providers and between providers and patients when measuring subjective symptoms. In the recently published Phase III N06C4 trial of mometasone cream vs. placebo to prevent radiation dermatitis, the primary provider-assessed (PA) endpoint, using the Common Toxicity Criteria for Adverse Events (CTCAE), was negative. However, prospectively planned secondary analyses of patient-reported outcomes (PROs), using the Skindex-16 and Skin Toxicity Assessment Tool (STAT), were positive. This study assesses the relationship between PA outcomes and PROs. Methods and Materials: Pearson correlation coefficients were calculated to compare the three tools. Statistical correlations were defined as follows: <0.5, mild; 0.5-0.7, moderate; and >0.7, strong. Results: CTCAE dermatitis moderately correlated with STAT erythema, and CTCAE pruritus strongly correlated with STAT itching. CTCAE pruritus had a moderate correlation with Skindex-16 itching. Comparing the 2 PRO tools, Skindex-16 itching correlated moderately with STAT itching. Skindex-16 burning, hurting, irritation, and persistence all showed the strongest correlation with STAT burning; they showed moderate correlations with STAT itching and tenderness. Conclusions: The PRO Skindex-16 correlated well with the PRO portions of STAT, but neither tool correlated well with CTCAE. PROs delineated a wider spectrum of toxicity than PA measures and provided more information on rash, redness, pruritus, and annoyance measures compared with CTCAE findings of rash and pruritus. PROs may provide a more complete measure of patient experience than single-symptom, PA endpoints in clinical trials assessing radiation skin toxicity.

  6. Is the use of antidepressants associated with patient-reported outcomes following total hip replacement surgery?

    PubMed

    Greene, Meridith E; Rolfson, Ola; Gordon, Max; Annerbrink, Kristina; Malchau, Henrik; Garellick, Göran

    2016-10-01

    Background and purpose - Patients with anxiety and/or depression tend to report less pain reduction and less satisfaction with surgical treatment. We hypothesized that the use of antidepressants would be correlated to patient-reported outcomes (PROs) 1 year after total hip replacement (THR), where increased dosage or discontinuation would be associated with worse outcomes. Patients and methods - THR cases with pre- and postoperative patient-reported outcome measures (PROMs) were selected from the Swedish Hip Arthroplasty Register (n = 9,092; women: n = 5,106). The PROMs were EQ-5D, visual analog scale (VAS) for pain, Charnley class, and VAS for satisfaction after surgery. These cases were merged with a national database of prescription purchases to determine the prevalence of antidepressant purchases. Regression analyses were performed where PROs were dependent variables and sex, age, Charnley class, preoperative pain, preoperative health-related quality of life (HRQoL), patient-reported anxiety/depression, and antidepressant use were independent variables. Results - Antidepressants were used by 10% of the cases (n = 943). Patients using antidepressants had poorer HRQoL and higher levels of pain before and after surgery and they experienced less satisfaction. Preoperative antidepressant use was independently associated with PROs 1 year after THR regardless of patient-reported anxiety/depression. Interpretation - Antidepressant usage before surgery was associated with reduced PROs after THR. Cases at risk of poorer outcomes may be identified through review of the patient's medical record. Clinicians are encouraged to screen for antidepressant use preoperatively, because their use may be associated with PROs after THR. PMID:27482877

  7. Patient-reported outcomes in post-traumatic stress disorder Part I: Focus on psychological treatment

    PubMed Central

    d'Ardenne, Patricia; Heke, Sarah

    2014-01-01

    Since 2000, patient reports have contributed significantly to the widening diagnostic criteria for post-traumatic stress disorder, notably with the inclusion of complex, repeated, and indirect threat to people who develop symptoms. This paper describes and explains why patient reports matter, through worldwide mental health users' movements and the human rights movement. It looks at 46 recent patient-reported outcomes of preferred psychological treatments in clinical research and practice, and compares them with clinician-reported outcomes, using rating scales that diagnose and measure therapeutic gains. Attention is given to one qualitative study of survivors of the London bombings as an example of patients' personal traumatic experiences. Understanding patients' views and their limitations can help increase success in trauma-focused therapy outcomes, particularly where patients fail to engage with or complete treatment, where they doubt the validity of the treatment, or do not see it as culturally appropriate, or fear of revisiting the past. Specific recommendations are made for a more collaborative approach with patients in psychiatric and community care and clinical research. PMID:25152659

  8. Patient-reported outcomes in post-traumatic stress disorder. Part I: focus on psychological treatment.

    PubMed

    d'Ardenne, Patricia; Heke, Sarah

    2014-06-01

    Since 2000, patient reports have contributed significantly to the widening diagnostic criteria for post-traumatic stress disorder, notably with the inclusion of complex, repeated, and indirect threat to people who develop symptoms. This paper describes and explains why patient reports matter, through worldwide mental health users' movements and the human rights movement. It looks at 46 recent patient-reported outcomes of preferred psychological treatments in clinical research and practice, and compares them with clinician-reported outcomes, using rating scales that diagnose and measure therapeutic gains. Attention is given to one qualitative study of survivors of the London bombings as an example of patients' personal traumatic experiences. Understanding patients' views and their limitations can help increase success in trauma-focused therapy outcomes, particularly where patients fail to engage with or complete treatment, where they doubt the validity of the treatment, or do not see it as culturally appropriate, or fear of revisiting the past. Specific recommendations are made for a more collaborative approach with patients in psychiatric and community care and clinical research.

  9. Quality of life as patient-reported outcomes: principles of assessment.

    PubMed

    Bullinger, Monika; Quitmann, Julia

    2014-06-01

    Assessing quality of life (QoL) as a patient-reported outcome in adult psychiatry poses challenges in terms of concepts, methods, and applications in research and practice. This review will outline conceptually the construct of QoL, its dimensionality, and its representation across patient groups. Methodological challenges are examined, along with principles of QoL instrument development and testing, as well as across cultures. Application of instruments in epidemiological, clinical health economics, and health services research is reviewed based on pertinent literature. Validated measures for depression, psychosis, and anxiety disorders are available in adult psychiatry, and are increasingly used in research. Still, targeted measures are lacking for many mental health conditions and only rarely are tools applied in the practice context. Progress has been made in the development of instruments that are now ready for implementation. The information to be gained is valuable for identifying patient-reported needs for and benefits of treatment.

  10. Quality of life as patient-reported outcomes: principles of assessment

    PubMed Central

    Bullinger, Monika; Quitmann, Julia

    2014-01-01

    Assessing quality of life (QoL) as a patient-reported outcome in adult psychiatry poses challenges in terms of concepts, methods, and applications in research and practice. This review will outline conceptually the construct of QoL, its dimensionality, and its representation across patient groups. Methodological challenges are examined, along with principles of QoL instrument development and testing, as well as across cultures. Application of instruments in epidemiological, clinical health economics, and health services research is reviewed based on pertinent literature. Validated measures for depression, psychosis, and anxiety disorders are available in adult psychiatry, and are increasingly used in research. Still, targeted measures are lacking for many mental health conditions and only rarely are tools applied in the practice context. Progress has been made in the development of instruments that are now ready for implementation. The information to be gained is valuable for identifying patient-reported needs for and benefits of treatment. PMID:25152653

  11. Functional Performance Testing and Patient Reported Outcomes following ACL Reconstruction: A Systematic Scoping Review.

    PubMed

    Almangoush, Adel; Herrington, Lee

    2014-01-01

    Objective. A systematic scoping review of the literature to identify functional performance tests and patient reported outcomes for patients who undergo anterior cruciate ligament (ACL) reconstruction and rehabilitation that are used in clinical practice and research during the last decade. Methods. A literature search was conducted. Electronic databases used included Medline, PubMed, Cochrane Library, EMBASE, CINAHL, SPORTDiscus, PEDro, and AMED. The inclusion criteria were English language, publication between April 2004 and April 2014, and primary ACL reconstruction with objective and/or subjective outcomes used. Two authors screened the selected papers for title, abstract, and full-text in accordance with predefined inclusion and exclusion criteria. The methodological quality of all papers was assessed by a checklist of the Critical Appraisal Skills Programme (CASP). Results. A total of 16 papers were included with full-text. Different authors used different study designs for functional performance testing which led to different outcomes that could not be compared. All papers used a measurement for quantity of functional performance except one study which used both quantity and quality outcomes. Several functional performance tests and patient reported outcomes were identified in this review. Conclusion. No extensive research has been carried out over the past 10 years to measure the quality of functional performance testing and control stability of patients following ACL reconstruction. However this study found that the measurement of functional performance following ACL reconstruction consisting of a one-leg hop for a set distance or a combination of different hops using limb symmetry index (LSI) was a main outcome parameter of several studies. A more extensive series of tests is suggested to measure both the quantitative and qualitative aspects of functional performance after the ACL reconstruction. The KOOS and the IKDC questionnaires are both measures that

  12. Functional Performance Testing and Patient Reported Outcomes following ACL Reconstruction: A Systematic Scoping Review

    PubMed Central

    Herrington, Lee

    2014-01-01

    Objective. A systematic scoping review of the literature to identify functional performance tests and patient reported outcomes for patients who undergo anterior cruciate ligament (ACL) reconstruction and rehabilitation that are used in clinical practice and research during the last decade. Methods. A literature search was conducted. Electronic databases used included Medline, PubMed, Cochrane Library, EMBASE, CINAHL, SPORTDiscus, PEDro, and AMED. The inclusion criteria were English language, publication between April 2004 and April 2014, and primary ACL reconstruction with objective and/or subjective outcomes used. Two authors screened the selected papers for title, abstract, and full-text in accordance with predefined inclusion and exclusion criteria. The methodological quality of all papers was assessed by a checklist of the Critical Appraisal Skills Programme (CASP). Results. A total of 16 papers were included with full-text. Different authors used different study designs for functional performance testing which led to different outcomes that could not be compared. All papers used a measurement for quantity of functional performance except one study which used both quantity and quality outcomes. Several functional performance tests and patient reported outcomes were identified in this review. Conclusion. No extensive research has been carried out over the past 10 years to measure the quality of functional performance testing and control stability of patients following ACL reconstruction. However this study found that the measurement of functional performance following ACL reconstruction consisting of a one-leg hop for a set distance or a combination of different hops using limb symmetry index (LSI) was a main outcome parameter of several studies. A more extensive series of tests is suggested to measure both the quantitative and qualitative aspects of functional performance after the ACL reconstruction. The KOOS and the IKDC questionnaires are both measures that

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

    PubMed

    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.

  14. Patient-reported outcomes in stuttering treatment: conceptual framework.

    PubMed

    Franic, Duska M; Bothe, Anne K

    2008-04-01

    Evaluation of: Yaruss JS, Quesal RW. Overall Assessment of the Speaker's Experience of Stuttering (OASES): documenting multiple outcomes in stuttering treatment. J. Fluency Disord. 31(2), 90-115 (2006) [1] . These authors presented the first complete instrument intended to measure the impact of stuttering in adults who stutter (Overall Assessment of the Speaker's Experience of Stuttering; [OASES]). OASES is a 100-item self-report metric with four sections: general information, reactions to stuttering, communication in daily situations and quality of life. Its conceptual framework includes historic views of the influence of emotional and cognitive variables on stuttering; the WHO's International Classification of Impairments, Disabilities and Handicaps (ICIDH); and the WHO's International Classification of Functioning, Disability and Health (ICF). However, both this conceptual framework and the psychometric data presented to support the OASES are problematic in ways that clinicians and researchers in areas well-beyond stuttering may find informative as they consider their own applications.

  15. Rose-colored answers: Neuropsychological deficits and patient-reported outcomes after stroke

    PubMed Central

    Barrett, Anna M.

    2010-01-01

    Patient-reported, subjective outcomes are promoted as a standard for ethical, valid studies in many neurological disorders. Such outcomes are considered potentially more sensitive and specific to important therapeutic effects, and may be more linked to disability and disease-related life losses than conventional assessments of impairment (e.g. ability to walk, performance on language tests, serological or radiological indices). Self-report is invaluable to identify social and emotional consequences of brain injury: depression, changes in intimate and family relationships, social role and community participation losses. However, common stroke-related neuropsychological deficits are likely to confound subjective stroke outcome measures. The scientific community focused on stroke-related health outcomes may arrive at significantly underestimated patient reports of stroke-related disability, caused by a failure to adjust for the effect on self-report of spatial neglect, deficits of magnitude estimation, pathologic alteration of self-awareness, and alteration in distributed cortical systems supporting emotional semantics and abstraction. PMID:20543455

  16. Impact of natalizumab on patient-reported outcomes in multiple sclerosis: a longitudinal study

    PubMed Central

    2012-01-01

    Background Natalizumab (Tysabri, Biogen Idec and Elan Pharmaceuticals) significantly reduces the relapse rate and disability progression, and improves health-related quality of life (HRQoL), in patients with relapsing-remitting multiple sclerosis. We investigated the impact of natalizumab on patient-reported outcomes (PROs) in a real-world setting. Methods PRO data were collected from patients enrolled in a longitudinal real-world study using validated measures administered as surveys before the patients initiated natalizumab treatment and after the 3rd, 6th, and 12th monthly infusion. HRQoL, ability to carry out daily activities, disability level, and impact on cognitive functioning and fatigue were assessed. Results A total of 333 patients completed 12 months of assessments. After 12 months of natalizumab treatment, 69% to 88% of patients reported a positive outcome (either an improvement or no further decline) in all PRO measures assessed. Significant improvements in general and disease-specific HRQoL were observed after three infusions, both with physical (p < .01) and psychological (p < .001) measures, and were sustained after 12 infusions (all p < .001). The impact of multiple sclerosis on cognitive functioning and fatigue was significantly reduced (both p < .001 after 3 and 12 infusions). Conclusions PRO measures were improved with natalizumab in a real-world setting. The improvements were observed as early as after 3 months and sustained over a 12-month period. The improvements in PROs show that, in clinical practice, the clinical benefits of natalizumab are translated into patient-reported benefits. PMID:23270428

  17. A Comparison of Magnetic Resonance Imaging Muscle Fat Content in the Lumbar Paraspinal Muscles with Patient-Reported Outcome Measures in Patients with Lumbar Degenerative Disk Disease and Focal Disk Prolapse.

    PubMed

    Bhadresha, Ashwin; Lawrence, Owen John; McCarthy, Michael J H

    2016-06-01

    Study Design Retrospective study. Objectives To assess the fatty atrophy of the lumbar paraspinal muscles (LPMs) as determined using magnetic resonance imaging in patients with lumbar degenerative disk disease (DDD) and focal disk herniation and to determine if fatty atrophy is associated with patient-reported outcome measures (PROMS). Methods One hundred sixty-five patients with lumbar DDD were identified from a PROMS database of >1,500 patients. These patients were divided into two study groups: DDD alone (n = 58) and DDD with disk herniation (n = 107). A grid was randomly applied to the axial scans at the L3-L4, L4-L5, and L5-S1 levels. The muscle-to-fat ratio of the LPMs was recorded and compared with PROMS data. Subcutaneous fat thickness at each level was also measured. Results This study found no difference in the muscle-to-fat ratio between the DDD and disk herniation groups. There was no association between the muscle-to-fat ratio and PROMS data in either group. There was significantly more subcutaneous fat at all levels in the DDD group as compared with the disk prolapse group. In DDD and disk prolapses, subcutaneous fat was thicker in women (p = 0.013 and 0.001). In patients with DDD, more subcutaneous fat was associated with disability (p < 0.001). Muscle content of erector spinae and multifidus negatively correlated with increasing age in both groups at the L3-L4 level. Conclusions Muscle fat content in the LPM does not appear to relate to PROMS. Muscle content decreases with age. Those with low back pain (DDD) have greater subcutaneous fat thickness. PMID:27190744

  18. A Comparison of Magnetic Resonance Imaging Muscle Fat Content in the Lumbar Paraspinal Muscles with Patient-Reported Outcome Measures in Patients with Lumbar Degenerative Disk Disease and Focal Disk Prolapse.

    PubMed

    Bhadresha, Ashwin; Lawrence, Owen John; McCarthy, Michael J H

    2016-06-01

    Study Design Retrospective study. Objectives To assess the fatty atrophy of the lumbar paraspinal muscles (LPMs) as determined using magnetic resonance imaging in patients with lumbar degenerative disk disease (DDD) and focal disk herniation and to determine if fatty atrophy is associated with patient-reported outcome measures (PROMS). Methods One hundred sixty-five patients with lumbar DDD were identified from a PROMS database of >1,500 patients. These patients were divided into two study groups: DDD alone (n = 58) and DDD with disk herniation (n = 107). A grid was randomly applied to the axial scans at the L3-L4, L4-L5, and L5-S1 levels. The muscle-to-fat ratio of the LPMs was recorded and compared with PROMS data. Subcutaneous fat thickness at each level was also measured. Results This study found no difference in the muscle-to-fat ratio between the DDD and disk herniation groups. There was no association between the muscle-to-fat ratio and PROMS data in either group. There was significantly more subcutaneous fat at all levels in the DDD group as compared with the disk prolapse group. In DDD and disk prolapses, subcutaneous fat was thicker in women (p = 0.013 and 0.001). In patients with DDD, more subcutaneous fat was associated with disability (p < 0.001). Muscle content of erector spinae and multifidus negatively correlated with increasing age in both groups at the L3-L4 level. Conclusions Muscle fat content in the LPM does not appear to relate to PROMS. Muscle content decreases with age. Those with low back pain (DDD) have greater subcutaneous fat thickness.

  19. A Comparison of Magnetic Resonance Imaging Muscle Fat Content in the Lumbar Paraspinal Muscles with Patient-Reported Outcome Measures in Patients with Lumbar Degenerative Disk Disease and Focal Disk Prolapse

    PubMed Central

    Bhadresha, Ashwin; Lawrence, Owen John; McCarthy, Michael J. H.

    2016-01-01

    Study Design Retrospective study. Objectives To assess the fatty atrophy of the lumbar paraspinal muscles (LPMs) as determined using magnetic resonance imaging in patients with lumbar degenerative disk disease (DDD) and focal disk herniation and to determine if fatty atrophy is associated with patient-reported outcome measures (PROMS). Methods One hundred sixty-five patients with lumbar DDD were identified from a PROMS database of >1,500 patients. These patients were divided into two study groups: DDD alone (n = 58) and DDD with disk herniation (n = 107). A grid was randomly applied to the axial scans at the L3–L4, L4–L5, and L5–S1 levels. The muscle-to-fat ratio of the LPMs was recorded and compared with PROMS data. Subcutaneous fat thickness at each level was also measured. Results This study found no difference in the muscle-to-fat ratio between the DDD and disk herniation groups. There was no association between the muscle-to-fat ratio and PROMS data in either group. There was significantly more subcutaneous fat at all levels in the DDD group as compared with the disk prolapse group. In DDD and disk prolapses, subcutaneous fat was thicker in women (p = 0.013 and 0.001). In patients with DDD, more subcutaneous fat was associated with disability (p < 0.001). Muscle content of erector spinae and multifidus negatively correlated with increasing age in both groups at the L3–L4 level. Conclusions Muscle fat content in the LPM does not appear to relate to PROMS. Muscle content decreases with age. Those with low back pain (DDD) have greater subcutaneous fat thickness. PMID:27190744

  20. The Association Between Patient-Reported and Objective Oral Anticancer Medication Adherence Measures: A Systematic Review

    PubMed Central

    Atkinson, Thomas M.; Rodríguez, Vivian M.; Gordon, Mallorie; Avildsen, Isabelle K.; Emanu, Jessica C.; Jewell, Sarah T.; Anselmi, Kimberly A.; Ginex, Pamela K.

    2016-01-01

    Problem Identification Oral anticancer medication (OAM) use has been steadily increasing, leading to several patient benefits. A notable challenge for nurses is accurate monitoring of patient OAM regimens because nonadherence is associated with poor health outcomes and decreased survival. Currently, no gold standard measure of OAM adherence exists. The authors conducted a systematic review of the association between objective and patient-reported measures of OAM adherence. Literature Search A systematic electronic literature search was conducted using PubMed, EMBASE, Scopus, PsycINFO®, Cochrane Library, Web of Science, and CINAHL® databases through November 2014. Data Evaluation Articles were independently reviewed to determine whether they included an original characterization of the level of association between objective and patient-reported measures of OAM adherence. Synthesis From a total of 11,135 articles retrieved, eight studies met inclusion criteria. Objective adherence was primarily assessed using pill counts or Medication Event Monitoring System (MEMSCap™). Patient-reported adherence was most commonly assessed using study-specific questionnaires. Significant positive correlations were observed between objective and patient-reported adherence across most studies, with three studies reporting higher rates of adherence via patient reporting. Conclusions Despite variation in the OAMs and measures used, patient-reported adherence rates were equal to or higher than objective adherence measures across studies. Social desirability bias may be a concern; however, given the significant concordance observed, using patient-reported methods in future studies of OAM adherence may be justified. Implications for Nursing This review provides evidence to support nursing use of patient-reported measures to accurately monitor OAM adherence and potentially improve the quality of patient–provider communication. PMID:27541550

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

    PubMed Central

    Johansson, Unn-Britt; Gudbjörnsdottir, Soffia

    2016-01-01

    Objectives There is a growing emphasis on the perspective of individuals living with diabetes and the need for a more person-centred diabetes care. At present, the Swedish National Diabetes Register (NDR) lacks patient-reported outcome measures (PROMs) based on the perspective of the patient. As a basis for a new PROM, the aim of this study was to describe important aspects in life for adult individuals with diabetes. Design Semistructured qualitative interviews analysed using content analysis. Setting Hospital-based outpatient clinics and primary healthcare clinics in Sweden. Participants 29 adults with type 1 diabetes mellitus (DM) (n=15) and type 2 DM (n=14). Inclusion criteria: Swedish adults (≥18 years) living with type 1 DM or type 2 DM (duration ≥5 years) able to describe their situation in Swedish. Purposive sampling generated heterogeneous characteristics. Results To live a good life with diabetes is demanding for the individual, but experienced barriers can be eased by support from others in the personal sphere, and by professional support from diabetes care. Diabetes care was a crucial resource to nurture the individual's ability and knowledge to manage diabetes, and to facilitate life with diabetes by supplying support, guidance, medical treatment and technical devices tailored to individual needs. The analysis resulted in the overarching theme ‘To live a good life with diabetes’ constituting the two main categories ‘How I feel and how things are going with my diabetes’ and ‘Support from diabetes care in managing diabetes’ including five different categories. Conclusions Common aspects were identified including the experience of living with diabetes and support from diabetes care. These will be used to establish a basis for a tailored PROM for the NDR. PMID:27013595

  2. Patient reported outcomes in the assessment of premature ejaculation

    PubMed Central

    2016-01-01

    The term ‘Patient Reported Outcome’, abbreviated as PRO, was introduced by the US Food and Drug Administration (FDA) which proposed guidance on the development and validation of PROs. Previously PROs were known as self-report diaries, event-logs, self-administered questionnaires, and clinician administered rating scales. PROs seek to capture the subjective perceptions of patients and/or partner’s related to their specific symptoms, degree of bother, efficacy of a medication or psychotherapy intervention, and quality of life issues related to a specific condition. This article reviews the essential psychometric and regulatory agency requirements in the development of PROs. The constructs of reliability, various forms of validity, sensitivity, and specificity as well as concerns with translating a PRO into a different language are reviewed. Three PROs, the Premature Ejaculation Profile (PEP), the Index of Premature Ejaculation (IPE) and the Premature Ejaculation Diagnostic Tool (PEDT) all used in the assessment of premature ejaculation (PE) are discussed. These questionnaires meet or exceed all the psychometric requirements and have been employed in clinical trials and observational studies of men with PE. The article concludes on discussing some of the limitations of PRO use and recommendations for the future.

  3. Patient reported outcomes in the assessment of premature ejaculation

    PubMed Central

    2016-01-01

    The term ‘Patient Reported Outcome’, abbreviated as PRO, was introduced by the US Food and Drug Administration (FDA) which proposed guidance on the development and validation of PROs. Previously PROs were known as self-report diaries, event-logs, self-administered questionnaires, and clinician administered rating scales. PROs seek to capture the subjective perceptions of patients and/or partner’s related to their specific symptoms, degree of bother, efficacy of a medication or psychotherapy intervention, and quality of life issues related to a specific condition. This article reviews the essential psychometric and regulatory agency requirements in the development of PROs. The constructs of reliability, various forms of validity, sensitivity, and specificity as well as concerns with translating a PRO into a different language are reviewed. Three PROs, the Premature Ejaculation Profile (PEP), the Index of Premature Ejaculation (IPE) and the Premature Ejaculation Diagnostic Tool (PEDT) all used in the assessment of premature ejaculation (PE) are discussed. These questionnaires meet or exceed all the psychometric requirements and have been employed in clinical trials and observational studies of men with PE. The article concludes on discussing some of the limitations of PRO use and recommendations for the future. PMID:27652219

  4. Patient-reported outcomes to support medical product labeling claims: FDA perspective.

    PubMed

    Patrick, Donald L; Burke, Laurie B; Powers, John H; Scott, Jane A; Rock, Edwin P; Dawisha, Sahar; O'Neill, Robert; Kennedy, Dianne L

    2007-01-01

    This article concerns development and use of patient-reported outcomes (PROs) in clinical trials to evaluate medical products. A PRO is any report coming directly from patients, without interpretation by physicians or others, about how they function or feel in relation to a health condition and its therapy. PRO instruments are used to measure these patient reports. PROs provide a unique perspective on medical therapy, because some effects of a health condition and its therapy are known only to patients. Properly developed and evaluated PRO instruments also have the potential to provide more sensitive and specific measurements of the effects of medical therapies, thereby increasing the efficiency of clinical trials that attempt to measure the meaningful treatment benefits of those therapies. Poorly developed and evaluated instruments may provide misleading conclusions or data that cannot be used to support product labeling claims. We review selected major challenges from Food and Drug Administration's perspective in using PRO instruments, measures, and end points to support treatment benefit claims in product labeling. These challenges highlight the need for sponsors to formulate desired labeling claim(s) prospectively, to acquire and document information needed to support these claim(s), and to identify existing instruments or develop new and more appropriate PRO instruments for evaluating treatment benefit in the defined population in which they will seek claims.

  5. US FDA patient-reported outcome guidance: great expectations and unintended consequences.

    PubMed

    Fehnel, Sheri; DeMuro, Carla; McLeod, Lori; Coon, Cheryl; Gnanasakthy, Ari

    2013-08-01

    Release of the US FDA patient-reported outcome (PRO) guidance raised expectations within the pharmaceutical industry for the use of PRO measures in support of labeling claims. The FDA developed the guidance with admirable intent, and the recommendations within this document are based on sound scientific principles. However, implementation of the guidance has been somewhat inconsistent within the Study Endpoints and Label Development (SEALD) and across the various FDA-reviewing divisions. Industry and regulatory bodies need to work toward gaining common ground to best support registration of treatments that could extend patients' lives, reduce symptoms, and/or improve health-related quality of life. PROs are valuable tools in communicating these messages, and realistic implementation of the FDA PRO Guidance may truly facilitate this process.

  6. Patient-reported outcomes as end points in clinical trials in rheumatoid arthritis

    PubMed Central

    Gossec, Laure; Dougados, Maxime; Dixon, William

    2015-01-01

    There is a growing interest in patient-reported outcomes (PROs) in rheumatology, which goes with a global trend for more ‘patient-centred care’. This review considers the use of PROs in trials, including their strengths and limitations. In rheumatoid arthritis (RA) trials, the most frequently used PROs to assess treatments include pain, patient global assessment, assessment of functional status, but also health-related quality of life and less commonly fatigue. Other aspects of importance for patients, such as sleep, psychological well-being or ability to cope, are rarely assessed. PROs as outcome measures in RA trials have strengths as well as limitations. PROs have face validity, they are reproducible and sensitive to change and they bring additional information beyond joint counts or acute phase reactants. However, their predictive validity for later outcomes has been little explored, some PROs show redundancy (they bring similar information) and, due to the apparently moderate link between some PROs such as fatigue and the disease process, the use of some PROs to inform treatment choices has been questioned. We suggest the choice of PROs for trials depends on the study objective and on the viewpoint of the stakeholder. There needs to be agreed prioritisation across all stakeholders about what is most important to collect in a trial, which is why a prioritisation and selection process is necessary. Trials in RA will continue to include PROs and their interpretation will become easier as our knowledge progresses. PMID:26509052

  7. Patient-reported outcomes as end points in clinical trials in rheumatoid arthritis.

    PubMed

    Gossec, Laure; Dougados, Maxime; Dixon, William

    2015-01-01

    There is a growing interest in patient-reported outcomes (PROs) in rheumatology, which goes with a global trend for more 'patient-centred care'. This review considers the use of PROs in trials, including their strengths and limitations. In rheumatoid arthritis (RA) trials, the most frequently used PROs to assess treatments include pain, patient global assessment, assessment of functional status, but also health-related quality of life and less commonly fatigue. Other aspects of importance for patients, such as sleep, psychological well-being or ability to cope, are rarely assessed. PROs as outcome measures in RA trials have strengths as well as limitations. PROs have face validity, they are reproducible and sensitive to change and they bring additional information beyond joint counts or acute phase reactants. However, their predictive validity for later outcomes has been little explored, some PROs show redundancy (they bring similar information) and, due to the apparently moderate link between some PROs such as fatigue and the disease process, the use of some PROs to inform treatment choices has been questioned. We suggest the choice of PROs for trials depends on the study objective and on the viewpoint of the stakeholder. There needs to be agreed prioritisation across all stakeholders about what is most important to collect in a trial, which is why a prioritisation and selection process is necessary. Trials in RA will continue to include PROs and their interpretation will become easier as our knowledge progresses. PMID:26509052

  8. A Systematic Review of Patient-reported Outcomes in Randomized Controlled Trials of Unplanned General Surgery.

    PubMed

    Stevens, Daniel J; Blencowe, Natalie S; McElnay, Philip J; Macefield, Rhiannon C; Savović, Jelena; Avery, Kerry N L; Blazeby, Jane M

    2016-02-01

    Unplanned general surgery represents a major workload and requires comprehensive evaluation with appropriate outcomes. This study aimed to summarize current reporting of patient-reported outcomes (PROs) in randomized clinical trials (RCTs) in unplanned general surgery. A systematic review identified RCTs reporting PROs in the commonest six areas of unplanned general surgery. Details of the PRO measures were examined using the CONSORT extension for PRO reporting in RCTs. Extracted information about each PRO domain included the reporting of baseline PROs, rationale for PRO selection and whether PRO findings were used in conjunction with clinical outcomes to inform treatment recommendations. The internal validity of included studies was assessed using the Cochrane risk of bias tool. 12,519 abstracts were screened and 20 RCTs containing data from 2037 patients included. Included studies used 14 separate PRO measures covering 35 different health domains. A visual analogue assessment of pain was most frequently reported (n = 13). Reporting of baseline PRO data was uncommon (11/35 PRO domains). The rationale for PRO data collection and a PRO-specific hypothesis were provided for 9 (25.7 %) and 5 (14.3 %) domains, respectively. Seventeen RCTs (85.0 %) used the PRO data alongside clinical outcomes to inform treatment recommendations. Of the 116 risk of bias assessments, 77 (66.0 %) were judged as high or unclear. There is a lack of well designed, and conducted RCTs in unplanned general surgery that include PROs. Future work to define relevant PROs and methods for optimal assessment are needed to inform health care decision-making.

  9. A Systematic Review of Patient-reported Outcomes in Randomized Controlled Trials of Unplanned General Surgery.

    PubMed

    Stevens, Daniel J; Blencowe, Natalie S; McElnay, Philip J; Macefield, Rhiannon C; Savović, Jelena; Avery, Kerry N L; Blazeby, Jane M

    2016-02-01

    Unplanned general surgery represents a major workload and requires comprehensive evaluation with appropriate outcomes. This study aimed to summarize current reporting of patient-reported outcomes (PROs) in randomized clinical trials (RCTs) in unplanned general surgery. A systematic review identified RCTs reporting PROs in the commonest six areas of unplanned general surgery. Details of the PRO measures were examined using the CONSORT extension for PRO reporting in RCTs. Extracted information about each PRO domain included the reporting of baseline PROs, rationale for PRO selection and whether PRO findings were used in conjunction with clinical outcomes to inform treatment recommendations. The internal validity of included studies was assessed using the Cochrane risk of bias tool. 12,519 abstracts were screened and 20 RCTs containing data from 2037 patients included. Included studies used 14 separate PRO measures covering 35 different health domains. A visual analogue assessment of pain was most frequently reported (n = 13). Reporting of baseline PRO data was uncommon (11/35 PRO domains). The rationale for PRO data collection and a PRO-specific hypothesis were provided for 9 (25.7 %) and 5 (14.3 %) domains, respectively. Seventeen RCTs (85.0 %) used the PRO data alongside clinical outcomes to inform treatment recommendations. Of the 116 risk of bias assessments, 77 (66.0 %) were judged as high or unclear. There is a lack of well designed, and conducted RCTs in unplanned general surgery that include PROs. Future work to define relevant PROs and methods for optimal assessment are needed to inform health care decision-making. PMID:26573174

  10. Patient-Reported Outcomes in Male and Female Collegiate Soccer Players During an Athletic Season

    PubMed Central

    Hoch, Johanna M.; Druvenga, Beth; Ferguson, Brittany A.; Houston, Megan N.; Hoch, Matthew C.

    2015-01-01

    Context  Clinicians are urged to document patient-based outcomes during rehabilitation to measure health-related quality of life (HRQOL) from the patient's perspective. It is unclear how scores on patient-reported outcome instruments (PROs) vary over the course of an athletic season because of normal athletic participation. Objective  Our primary purpose was to evaluate the effect of administration time point on HRQOL during an athletic season. Secondary purposes were to determine test-retest reliability and minimal detectable change scores of 3 PROs commonly used in clinical practice and if a relationship exists between generic and region-specific outcome instruments. Design  Cross-sectional study. Setting  Athletic facility. Patients or Other Participants  Twenty-three collegiate soccer athletes (11 men, 12 women). Main Outcome Measure(s)  At 5 time points over a spring season, we administered the Disablement in the Physically Active Scale (DPA), Foot and Ankle Ability Measure-Sport, and Knee Injury and Osteoarthritis Outcome Score (KOOS). Results  Time effects were observed for the DPA (P = .011) and KOOS Quality of Life subscale (P = .027). However, the differences between individual time points did not surpass the minimal detectable change for the DPA, and no post hoc analyses were significant for the KOOS-Quality of Life subscale. Test-retest reliability was moderate for the KOOS-Pain subscale (intraclass correlation coefficient = 0.71) and good for the remaining KOOS subscales, DPA, and Foot and Ankle Ability Measure-Sport (intraclass correlation coefficients > 0.79). The DPA and KOOS-Sport subscale demonstrated a significant moderate relationship (P = .018). Conclusions  Athletic participation during a nontraditional, spring soccer season did not affect HRQOL. All 3 PROs were reliable and could be used clinically to monitor changes in health status throughout an athletic season. Our results demonstrate that significant deviations in scores

  11. The importance of patient-reported outcomes: a call for their comprehensive integration in cardiovascular clinical trials.

    PubMed

    Anker, Stefan D; Agewall, Stefan; Borggrefe, Martin; Calvert, Melanie; Jaime Caro, J; Cowie, Martin R; Ford, Ian; Paty, Jean A; Riley, Jillian P; Swedberg, Karl; Tavazzi, Luigi; Wiklund, Ingela; Kirchhof, Paulus

    2014-08-01

    Patient-reported outcomes (PROs), such as symptoms, health-related quality of life (HRQOL), or patient perceived health status, are reported directly by the patient and are powerful tools to inform patients, clinicians, and policy-makers about morbidity and 'patient suffering', especially in chronic diseases. Patient-reported outcomes provide information on the patient experience and can be the target of therapeutic intervention. Patient-reported outcomes can improve the quality of patient care by creating a holistic approach to clinical decision-making; however, PROs are not routinely used as key outcome measures in major cardiovascular clinical trials. Thus, limited information is available on the impact of cardiovascular therapeutics on PROs to guide patient-level clinical decision-making or policy-level decision-making. Cardiovascular clinical research should shift its focus to include PROs when evaluating the efficacy of therapeutic interventions, and PRO assessments should be scientifically rigorous. The European Society of Cardiology and other professional societies can take action to influence the uptake of PRO data in the research and clinical communities. This process of integrating PRO data into comprehensive efficacy evaluations will ultimately improve the quality of care for patients across the spectrum of cardiovascular disease.

  12. Patient-reported outcomes as primary end points in clinical trials of inflammatory bowel disease.

    PubMed

    Williet, Nicolas; Sandborn, William J; Peyrin-Biroulet, Laurent

    2014-08-01

    The Food and Drug Administration (FDA) is moving from the Crohn's Disease Activity Index to patient-reported outcomes (PROs) and objective measures of disease, such as findings from endoscopy. PROs will become an important aspect of assessing activity of inflammatory bowel disease (IBD) and for labeling specific drugs for this disease. PROs always have been considered in the management of patients with rheumatoid arthritis or multiple sclerosis, and have included measurements of quality of life, disability, or fatigue. Several disease-specific scales have been developed to assess these PROs and commonly are used in clinical trials. Outcomes reported by patients in clinical trials of IBD initially focused on quality of life, measured by the Short-Form 36 questionnaire or disease-specific scales such as the Inflammatory Bowel Disease Questionnaire or its shorter version. Recently considered factors include fatigue, depression and anxiety, and work productivity, as measured by the Functional Assessment Chronic Illness Therapy-Fatigue, the Hospital Anxiety Depression, and the Work Productivity Activity Impairment Questionnaire, respectively. However, few data are available on how treatment affects these factors in patients with IBD. Although disability generally is recognized in patients with IBD, it is not measured. The international IBD disability index currently is being validated. None of the PROs currently used in IBD were developed according to FDA guidance for PRO development. PROs will be a major primary end point of future trials. FDA guidance is needed to develop additional PROs for IBD that can be incorporated into trials, to better compare patients' experience with different therapies. PMID:24534550

  13. Patient-Reported Outcomes in Metastatic Breast Cancer: A Review of Industry-Sponsored Clinical Trials

    PubMed Central

    Krohe, Meaghan; Hao, Yanni; Lamoureux, Roger E.; Galipeau, Nina; Globe, Denise; Foley, Catherine; Mazar, Iyar; Solomon, Jeffrey; Shields, Alan L.

    2016-01-01

    INTRODUCTION Patient-reported outcome (PRO) measures serve to capture vital patient information not otherwise obtained by primary study endpoints. This paper examines how PROs are utilized as endpoints in industry-sponsored metastatic breast cancer clinical trials. METHODS A search was conducted in the clinicaltrials.gov web site for trials involving common treatments for metastatic breast cancer. Thirty-eight clinical trials were identified which included a PRO endpoint in the study, and data were extracted and summarized. RESULTS Overall, 17 unique PRO questionnaires and 14 concepts of measurement were identified as secondary or exploratory endpoints. The Functional Assessment of Cancer Therapy—Breast was the most frequently utilized questionnaire, commonly implemented to assess quality of life. The EORTC QLQ-C30 was also frequently used to measure quality of life or pain. CONCLUSION This review shares insights into the role of PROs in trials for metastatic breast cancer from which treatment developers and other stakeholders can enhance successful implementation of the patient voice into future trials. PMID:27441001

  14. Patient-Reported Outcomes Are Changing the Landscape in Oncology Care: Challenges and Opportunities for Payers

    PubMed Central

    Zagadailov, Erin; Fine, Michael; Shields, Alan

    2013-01-01

    Background A patient-reported outcome (PRO) is a subjective report that comes from a patient without interpretation by a clinician. Because of the increasingly significant role of PROs in the development and evaluation of new medicines, the US Food and Drug Administration (FDA) issued a formal guidance to describe how PRO instruments will be reviewed and evaluated with respect to claims in approved medical product labeling. Meanwhile, PROs continue to appear in oncology clinical trials more frequently; however, it is unclear how payers and policymakers can use PRO data in the context of decision-making for cancer treatments. Objective The objective of this article is to discuss the challenges and opportunities of incorporating oncology-related PRO data into payer decision-making. Discussion Payer concerns with PRO instruments are often related to issues regarding measurement, relevance, quality, and interpretability of PROs. Payers may dismiss PROs that do not independently predict improved outcomes. The FDA guidance released in 2009 demonstrates, as evidenced by the case of ruxolitinib, how PRO questionnaires can be generated in a relevant, trustworthy, and meaningful way, which provides an opportunity for payers and policy decision makers to focus on how to use PRO data in their decision-making. This is particularly relevant in oncology, where a recent and sizable number of clinical trials include PRO measures. Conclusion As an increasing number of oncology medications enter the market with product labeling claims that contain PRO data, payers will need to better familiarize themselves with the opportunities associated with PRO questionnaires when making coverage decisions. PRO measures will continue to provide valuable information regarding the risk–benefit profile of novel agents. As such, PRO measures may provide evidence that should be considered in payers' decisions and discussions; however, the formal role of PROs and the pertinence of PROs in decision

  15. Patient Expectations and Patient-Reported Outcomes in Surgery: A Systematic Review

    PubMed Central

    Waljee, Jennifer; McGlinn, Evan P.; Sears, Erika Davis; Chung, Kevin C.

    2014-01-01

    Background Recent events in healthcare reform have brought national attention to integrating patient experiences and expectations into quality metrics. Few studies have comprehensively evaluated the effect of patient expectations on patient-reported outcomes (PROs) following surgery. The purpose of this study is to systematically review the available literature describing the relationship between patient expectations and postoperative PROs. Methods We performed a search of the literature published prior to November 1, 2012. Articles were included in the review if 1) primary data were presented 2) patient expectations regarding a surgical procedure were measured 3) PROs were measured, and 4) the relationship between patient expectations and PROs was specifically examined. PROs were categorized into five subgroups: satisfaction, quality of life (QOL), disability, mood disorder, and pain. We examined each study to determine the relationship between patient expectations and PROs as well as study quality. Results From the initial literature search yielding 1,708 studies, 60 articles were included. Fulfillment of expectations was associated with improved PROs among 24 studies. Positive expectations were correlated with improved PROs for 28 (47%) studies, and poorer PROs for 9 (15%) studies. Eighteen studies reported that fulfillment of expectations was correlated with improved patient satisfaction, and 10 studies identified that positive expectations were correlated with improved postoperative QOL. Finally, patients with positive preoperative expectations reported less pain (8 studies) and disability (15 studies) compared with patients with negative preoperative expectations. Conclusions Patient expectations are inconsistently correlated with PROs following surgery, and there is no accepted method to capture perioperative expectations. Future efforts to rigorously measure expectations and explore their influence on postoperative outcomes can inform clinicians and policy

  16. The Impact of Waiting Time on Health Gains from Surgery: Evidence from a National Patient-reported Outcome Dataset.

    PubMed

    Nikolova, Silviya; Harrison, Mark; Sutton, Matt

    2016-08-01

    Reducing waiting times has been a major focus of the English National Health Service for many years, but little is known about the impact on health outcomes. The collection of data on patient-reported outcome measures for all patients undergoing four large-volume procedures facilitates analysis of the impact of waiting times on patient outcomes. The availability of patient-reported outcome measures before and after surgery allows us to estimate the impact of waiting times on the effectiveness of treatment, controlling for pre-surgery health and the endogeneity of waiting times caused by prioritisation with respect to pre-intervention health. We find that waiting time has a negative and statistically significant impact on the health gain from hip and knee replacement surgery and no impact on the effectiveness of varicose vein and hernia surgery. The magnitude of this effect at patient level is small, 0.1% of the outcome measure range for each additional week of waiting. However, the value of this effect is substantially larger than existing estimates of the disutility experienced during the waiting period. The health losses associated with an additional week of waiting for annual populations of hip and knee replacement patients are worth £11.1m and £11.5m, respectively. Copyright © 2015 John Wiley & Sons, Ltd. PMID:26013773

  17. The Impact of Waiting Time on Health Gains from Surgery: Evidence from a National Patient-reported Outcome Dataset.

    PubMed

    Nikolova, Silviya; Harrison, Mark; Sutton, Matt

    2016-08-01

    Reducing waiting times has been a major focus of the English National Health Service for many years, but little is known about the impact on health outcomes. The collection of data on patient-reported outcome measures for all patients undergoing four large-volume procedures facilitates analysis of the impact of waiting times on patient outcomes. The availability of patient-reported outcome measures before and after surgery allows us to estimate the impact of waiting times on the effectiveness of treatment, controlling for pre-surgery health and the endogeneity of waiting times caused by prioritisation with respect to pre-intervention health. We find that waiting time has a negative and statistically significant impact on the health gain from hip and knee replacement surgery and no impact on the effectiveness of varicose vein and hernia surgery. The magnitude of this effect at patient level is small, 0.1% of the outcome measure range for each additional week of waiting. However, the value of this effect is substantially larger than existing estimates of the disutility experienced during the waiting period. The health losses associated with an additional week of waiting for annual populations of hip and knee replacement patients are worth £11.1m and £11.5m, respectively. Copyright © 2015 John Wiley & Sons, Ltd.

  18. Usefulness of Patients-Reported Outcomes in Rheumatoid Arthritis Focus Group

    PubMed Central

    Amaya-Amaya, Jenny; Botello-Corzo, Diana; Calixto, Omar-Javier; Calderón-Rojas, Rolando; Domínguez, Aura-Maria; Cruz-Tapias, Paola; Montoya-Ortiz, Gladis; Mantilla, Ruben-Dario; Anaya, Juan-Manuel; Rojas-Villarraga, Adriana

    2012-01-01

    Objective. Patient-reported outcomes (PROs) have become an essential part of the assessment of patients with rheumatoid arthritis (RA). We aimed to evaluate the agreement and correlation between PROs and the physician's measurements. Methods. This was a cross-sectional analytical study in which 135 patients with RA were clinically evaluated during two different sessions of focus group interviews. Rheumatologist recorded 28 swollen (SJCs) and tender joint counts (TJCs). The patients filled out the PROs instruments (MDHAQ, RADAI, RAPID3, 4, and 5 and self-report articular index (SAI) diagram for pain and joint swelling). DAS28 was calculated (C-reactive protein). An adjusted multiple lineal regression model was done (DAS28 as dependent variable). Results. Highly significant agreements were found between SJC and TJC registered by the physician and patient. There was moderate correlation between DAS28 with patient SJC (r = 0.52), patient TJC (r = 0.55), RADAI (r = 0.56), RAPID3 (r = 0.52), RAPID4 (r = 0.56), RAPID5 (r = 0.66), and VAS-Global (r = 0.51). Likewise, we found moderate to high correlations between CDAI and SDAI with all variable measurements done by the patients. The resulting predictive equation was DAS28(CRP) = 2.02 + 0.037 × RAPID4 + 0.042× patient SJC. Conclusion. PROs applied in focus groups interview are a useful tool for managing patients with RA regardless of gender, educational level, and duration of disease. PMID:23097701

  19. Patient-reported outcomes and considerations in the management of COPD: focus on aclidinium.

    PubMed

    Lopez-Campos, Jose Luis; Calero, Carmen; Lopez-Ramirez, Cecilia; Asensio-Cruz, Maria Isabel; Márquez-Martín, Eduardo; Ortega-Ruiz, Francisco

    2015-01-01

    Chronic obstructive pulmonary disease (COPD) is a complex heterogeneous disease, in which several factors combine to give the final clinical expression. Both early and more recent studies have shown that forced expiratory volume in one second (FEV1), despite being an extremely important parameter to predict the progression of the disease, is a poor surrogate marker for symptoms perception. Accordingly, patient-reported outcomes (PROs) have gained popularity as a measure of the impact of treatment from the patients' perspective, since they represent the individuals' perception of their health status, beyond any physiological limitations. Several such PROs, therefore, are currently included in multidimensional COPD evaluation. This multidimensional approach helps identify different patient types and individualize, up to a certain point, pharmacological treatment. In this multidimensional approach it is important to highlight the importance of long-acting bronchodilators in COPD treatment strategies. Long-acting bronchodilators are cost-effective and have been shown to achieve the greatest functional and clinical improvements in COPD. As a result, long-acting bronchodilators are now the main pharmacological treatment for COPD at all stages of the disease. Until recently, tiotropium was the leading bronchodilator for the treatment of COPD. The clinical development of this medication, unprecedented in inhaled therapy, involved tens of thousands of patients and yielded consistent outcomes in terms of lung function, symptoms, quality of life, exacerbations, and prognosis. However, new long-acting bronchodilators have recently been developed or are currently under development. In this review, we evaluate the effects of aclidinium bromide, a novel long-acting bronchodilator, on PROs in COPD. Aclidinium is a novel long-acting muscarinic antagonist with a good safety profile for the treatment of COPD, and has proven efficacy in both objective functional measurements and PROs

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

    PubMed Central

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

    2016-01-01

    Introduction: 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. Case Description: 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. Strategies: 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. Conclusion: These experiences and lessons may help future implementers and researchers enhance the scale and sustainable use of systems for research use of PROs. PMID:27563683

  1. Patient-reported outcomes and the evolution of adverse event reporting in oncology.

    PubMed

    Trotti, Andy; Colevas, A Dimitrios; Setser, Ann; Basch, Ethan

    2007-11-10

    Adverse event (AE) reporting in oncology has evolved from informal descriptions to a highly systematized process. The Common Terminology Criteria for Adverse Events (CTCAE) is the predominant system for describing the severity of AEs commonly encountered in oncology clinical trials. CTCAE clinical descriptors have been developed empirically during more than 30 years of use. The method of data collection is clinician based. Limitations of the CTC system include potential for incomplete reporting and limited guidance on data analysis and presentation methods. The Medical Dictionary for Regulatory Activities (MedDRA) is a comprehensive medical terminology system used for regulatory reporting and drug labeling. MedDRA does not provide for severity ranking of AEs. CTC-based data presentations are the primary method of AE data reporting used in scientific journals and oncology meetings. Patient-reported outcome instruments (PROs) cover the subjective domain of AEs. Exploratory work suggests PROs can be used with a high degree of patient engagement and compliance. Additional studies are needed to determine how PROs can be used to complement current AE reporting systems. Potential models for integrating PROs into AE reporting are described in this review. AE reporting methods will continue to evolve in response to changing therapies and growing interest in measuring the impact of cancer treatment on health status. Although integration of PROs into AE reporting may ultimately improve the comprehensiveness and quality of collected data, it may also increase the administrative burden and cost of conducting trials. Therefore, care must be used when developing health outcomes and safety data collection plans. PMID:17991931

  2. Patient-Reported Outcome Assessments as Endpoints in Studies in Infectious Diseases.

    PubMed

    Powers, John H; Howard, Kellee; Saretsky, Todd; Clifford, Sarah; Hoffmann, Steve; Llorens, Lily; Talbot, George

    2016-08-15

    The goal of administering medical interventions is to help patients live longer or live better. In keeping with this goal, there has been increasing interest in taking the "voice" of the patient into account during the development process, specifically in the evaluation of treatment benefits of medical interventions, and use of patient-centered outcome data to justify reimbursement. Patient-reported outcomes (PROs) are outcome assessments (OAs) used to define endpoints that can provide direct evidence of treatment benefit on how patients feel or function. When PROs are appropriately developed, they can increase the efficiency and clinical relevance of clinical trials. Several PROs have been developed for OA in specific infectious diseases indications, and more are under development. PROs also hold promise for use in evaluating adherence, adverse effects, satisfaction with care, and routine clinical practice. PMID:27481954

  3. Regression models for patient-reported measures having ordered categories recorded on multiple occasions

    PubMed Central

    Preisser, J. S.; Phillips, C.; Perin, J.; Schwartz, T. A.

    2011-01-01

    Objectives The article reviews proportional and partial proportional odds regression for ordered categorical outcomes, such as patient-reported measures, that are frequently used in clinical research in dentistry. Methods The proportional odds regression model for ordinal data is a generalization of ordinary logistic regression for dichotomous responses. When the proportional odds assumption holds for some but not all of the covariates, the lesser known partial proportional odds model is shown to provide a useful extension. Results The ordinal data models are illustrated for the analysis of repeated ordinal outcomes to determine whether the burden associated with sensory alteration following a bilateral sagittal split osteotomy procedure differed for those patients who were given opening exercises only following surgery and those who received sensory retraining exercises in conjunction with standard opening exercises. Conclusions Proportional and partial proportional odds models are broadly applicable to the analysis of cross-sectional and longitudinal ordinal data in dental research. PMID:21070317

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

    PubMed

    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. PMID:23771340

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

    PubMed Central

    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.

    2013-01-01

    .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. PMID:23771340

  6. Web-based patient-reported outcomes in drug safety and risk management: challenges and opportunities?

    PubMed

    Banerjee, Anjan K; Ingate, Simon

    2012-06-01

    Patient-reported outcomes (PROs) from web-based sources are becoming increasingly important, providing opportunities for industry and regulators to understand the benefits and risks of medicines in a real-world context. Although some guidance exists for the use of adverse event (AE) reports from company-sponsored social network sites, this does not cover non-company-sponsored sites. Additionally, there are concerns about the validity of data from social media sources. Techniques for the collection, analysis and reporting of safety data from patients should be defined, and guidelines agreed, to cover PROs and patient-reported adverse drug-related events from more organized sources of patient outcomes. This review considers drivers for web-based PRO adoption in drug safety, the current regulatory framework and potential methodologies, and concludes that there is an urgent unmet need for guidelines on web-based PRO AEs. Stakeholders for the development of any such guidance should include industry, patients, regulators, academic groups and prescribers. PMID:22551007

  7. Programmatic assessment of a university-based implant training program using patient-reported outcomes.

    PubMed

    Al-Sabbagh, Mohanad; Jenkins, Diane W; de Leeuw, Reny; Nihill, Patricia; Robinson, Fonda G; Thomas, Mark V

    2014-11-01

    The University of Kentucky College of Dentistry (UKCD) established an implant training program that provides training in the use of a single implant system, evidence-based diagnostic and treatment protocols (standardized work practices), and a total quality management system (Implant Quality Assurance Program). The aim of this study was to assess the programmatic effectiveness of the UKCD implant training program by reporting the success and survival of implants placed, using patient-reported outcomes and comparing them to previously established benchmarks. A total of 415 patients (963 implants) were interviewed, approximately 50 percent of all qualified patients. The implant survival rate was 97 percent, and 88 percent of the implants were considered successful (as determined by patient-centric criteria). These outcomes were consistent with the program's previously established benchmarks of 90 percent. These results suggest that work standardization (in the form of specific treatment protocols) and the use of a formal, incremental learning system can result in positive patient outcomes. Clinical outcomes should be monitored in academic dental settings as part of clinical process improvement, and these outcomes can provide a means of assessing the effectiveness of the training program.

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

    PubMed Central

    2012-01-01

    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 motivation to change

  9. Patient-reported outcomes of parenteral somatostatin analogue injections in 195 patients with acromegaly

    PubMed Central

    Strasburger, Christian J; Karavitaki, Niki; Störmann, Sylvère; Trainer, Peter J; Kreitschmann-Andermahr, Ilonka; Droste, Michael; Korbonits, Márta; Feldmann, Berit; Zopf, Kathrin; Sanderson, Violet Fazal; Schwicker, David; Gelbaum, Dana; Haviv, Asi; Bidlingmaier, Martin; Biermasz, Nienke R

    2016-01-01

    Background Long-acting somatostatin analogues delivered parenterally are the most widely used medical treatment in acromegaly. This patient-reported outcomes survey was designed to assess the impact of chronic injections on subjects with acromegaly. Methods The survey was conducted in nine pituitary centres in Germany, UK and The Netherlands. The questionnaire was developed by endocrinologists and covered aspects of acromegaly symptoms, injection-related manifestations, emotional and daily life impact, treatment satisfaction and unmet medical needs. Results In total, 195 patients participated, of which 112 (57%) were on octreotide (Sandostatin LAR) and 83 (43%) on lanreotide (Somatuline Depot). The majority (>70%) of patients reported acromegaly symptoms despite treatment. A total of 52% of patients reported that their symptoms worsen towards the end of the dosing interval. Administration site pain lasting up to a week following injection was the most frequently reported injection-related symptom (70% of patients). Other injection site reactions included nodules (38%), swelling (28%), bruising (16%), scar tissue (8%) and inflammation (7%). Injection burden was similar between octreotide and lanreotide. Only a minority of patients received injections at home (17%) and 5% were self-injecting. Over a third of patients indicated a feeling of loss of independence due to the injections, and 16% reported repeated work loss days. Despite the physical, emotional and daily life impact of injections, patients were satisfied with their treatment, yet reported that modifications that would offer major improvement over current care would be ‘avoiding injections’ and ‘better symptom control’. Conclusion Lifelong injections of long-acting somatostatin analogues have significant burden on the functioning, well-being and daily lives of patients with acromegaly. PMID:26744896

  10. Considerations for Developing Interfaces for Collecting Patient-Reported Outcomes That Allow the Inclusion of Individuals With Disabilities

    PubMed Central

    Harniss, Mark; Amtmann, Dagmar; Cook, Debbie; Johnson, Kurt

    2010-01-01

    PROMIS (Patient-Reported Outcome Measurement Information System) is developing a set of tools for collecting patient reported outcomes, including computerized adaptive testing that can be administered using different modes, such as computers or phones. The user interfaces for these tools will be designed using the principles of universal design to ensure that it is accessible to all users, including those with disabilities. We review the rationale for making health assessment instruments accessible to users with disabilities, briefly review the standards and guidelines that exist to support developers in the creation of user interfaces with accessibility in mind, and describe the usability and accessibility testing PROMIS will conduct with content experts and users with and without disabilities. Finally, we discuss threats to validity and reliability presented by universal design principles. We argue that the social and practical benefits of interfaces designed to include a broad range of potential users, including those with disabilities, seem to outweigh the need for standardization. Suggestions for future research are also included. PMID:17443119

  11. The rationale for patient-reported outcomes surveillance in cancer and a reproducible method for achieving it.

    PubMed

    Smith, Tenbroeck G; Castro, Kathleen M; Troeschel, Alyssa N; Arora, Neeraj K; Lipscomb, Joseph; Jones, Shelton M; Treiman, Katherine A; Hobbs, Connie; McCabe, Ryan M; Clauser, Steven B

    2016-02-01

    Patient-reported outcomes (PROs) measure quality of life, symptoms, patient functioning, and patient perceptions of care; they are essential for gaining a full understanding of cancer care and the impact of cancer on people's lives. Repeatedly captured facility-level and/or population-level PROs (PRO surveillance) could play an important role in quality monitoring and improvement, benchmarking, advocacy, policy making, and research. This article describes the rationale for PRO surveillance and the methods of the Patient Reported Outcomes Symptoms and Side Effects Study (PROSSES), which is the first PRO study to use the American College of Surgeons Commission on Cancer's Rapid Quality Reporting System to identify patients and manage study data flow. The American Cancer Society, the National Cancer Institute, the Commission on Cancer, and RTI International collaborated on PROSSES. PROSSES was conducted at 17 cancer programs that participated in the National Cancer Institute Community Cancer Centers Program among patients diagnosed with locoregional breast or colon cancer. The methods piloted in PROSSES were successful as demonstrated by high eligibility (93%) and response (61%) rates. Differences in clinical and demographic characteristics between respondents and nonrespondents were mostly negligible, with the exception that non-white individuals were somewhat less likely to respond. These methods were consistent across cancer centers and reproducible over time. If repeated and expanded, they could provide PRO surveillance data from patients with cancer on a national scale.

  12. Patient-reported outcomes before and after treatment of major depressive disorder.

    PubMed

    IsHak, Waguih William; Mirocha, James; Pi, Sarah; Tobia, Gabriel; Becker, Bret; Peselow, Eric D; Cohen, Robert M

    2014-06-01

    Patient reported outcomes (PROs) of quality of life (QoL), functioning, and depressive symptom severity are important in assessing the burden of illness of major depressive disorder (MDD) and to evaluate the impact of treatment. We sought to provide a detailed analysis of PROs before and after treatment of MDD from the large Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study. This analysis examines PROs before and after treatment in the second level of STAR*D. The complete data on QoL, functioning, and depressive symptom severity, were analyzed for each STAR*D level 2 treatment. PROs of QoL, functioning, and depressive symptom severity showed substantial impairments after failing a selective serotonin reuptake inhibitor trial using citalopram (level 1). The seven therapeutic options in level 2 had positive statistically (P values) and clinically (Cohen's standardized differences [Cohen's d]) significant impact on QoL, functioning, depressive symptom severity, and reduction in calculated burden of illness. There were no statistically significant differences between the interventions. However, a substantial proportion of patients still suffered from patient-reported QoL and functioning impairment after treatment, an effect that was more pronounced in nonremitters. PROs are crucial in understanding the impact of MDD and in examining the effects of treatment interventions, both in research and clinical settings.

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

    PubMed Central

    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

  14. The BODY-Q: A Patient-Reported Outcome Instrument for Weight Loss and Body Contouring Treatments

    PubMed Central

    Cano, Stefan J.; Alderman, Amy; Soldin, Mark; Thoma, Achilles; Robson, Sam; Kaur, Manraj; Papas, Athanasios; Van Laeken, Nancy; Taylor, Valerie H.; Pusic, Andrea L.

    2016-01-01

    Background: Body contouring performed for cosmetic purposes, or after weight loss, has the potential to improve body image and health-related quality of life (HRQL). The BODY-Q is a new patient-reported outcome (PRO) instrument designed to measure patient perceptions of weight loss and/or body contouring. In this article, we describe the psychometric properties of the BODY-Q scales after an international field-test. Methods: Weight loss and body contouring patients from Canada, United States, and United Kingdom were recruited between November 2013 and February 2015. Data were collected using an iPad directly into a web-based application or a questionnaire booklet. Rasch measurement theory analysis was used for item reduction and to examine reliability, validity, and ability to detect change. Results: The sample included 403 weight loss and 331 body contouring patients. Most BODY-Q items had ordered thresholds (134/138) and good item fit. Scale reliability was acceptable, ie, Person separation index >0.70 for 16 scales, Cronbach α ≥0.90 for 18 of 18 scales, and Test–retest ≥0.87 for 17 of 18 scales. Appearance and HRQL scores were lower in participants with more obesity-related symptoms, higher body mass index, and more excess skin and in those pre- versus postoperative body contouring. The 134 weight loss patients who completed the BODY-Q twice, either 6 weeks (weight loss/nonsurgical body contouring program) or 6 months (bariatric program) later, improved significantly on 7 appearance and 4 HRQL scales. Conclusion: The BODY-Q is a clinically meaningful and scientifically sound patient-reported outcome instrument that can be used to measure outcomes in patients who undergo weight loss and/or body contouring. PMID:27200241

  15. Implementation of an ODM and HL7 Compliant Electronic Patient-Reported Outcome System.

    PubMed

    Soto-Rey, Iñaki; Dugas, Martin; Storck, Michael

    2016-01-01

    Interoperability is one of the biggest issues in health informatics despite of the huge effort invested to solve it. Clinical Data Interchange Standards Consortium (CDISC) and Health Level 7 (HL7) are two of the most recognized institutions working on this field. Several systems are becoming compliant with their standards; however, the process to accomplish it is not always straightforward. In this manuscript, we present the successful implementation of the CDISC ODM and HL7 import and export functions for "MoPat", a web-based multi-language electronic patient-reported outcomes system. The system has been evaluated and tested and is currently being used for clinical study and routine data collection, including more than 10.000 patient encounters. PMID:27577417

  16. Patient-reported outcomes of brentuximab vedotin in Hodgkin lymphoma and anaplastic large-cell lymphoma

    PubMed Central

    Chen, Robert; Allibone, Suzanne; Bartlett, Nancy L; Brice, Pauline; Chen, Andy; Pose, Katrina; Rich, Lynn; Bonthapally, Vijay; Garfin, Phillip M; Fanale, Michelle

    2016-01-01

    Background Patients with relapsed/refractory (R/R) Hodgkin lymphoma (HL) or R/R systemic anaplastic large-cell lymphoma (sALCL) treated with brentuximab vedotin (BV) experienced high remission rates in two Phase II trials. With increased response rates and survival times, patient-reported outcomes (PROs) and health-related quality of life (HRQoL) are becoming increasingly important and can help inform treatment decisions to enhance care of cancer patients. Objective The objective was to qualitatively assess HRQoL in long-term survivors treated with BV. Methods An eight-question survey assessing PRO-related aspects was developed and fielded to a subset of patients with HL or sALCL who remained in long-term follow-up after completing BV treatment in the two pivotal studies. Results The survey was completed by 25 of 38 patients (12 with HL, 13 with sALCL). The majority of patients reported that their energy level, outlook on life, difficulties with daily activities, ability to participate in physical activities, and overall HRQoL improved compared to those before BV treatment. Limitations Small sample size and lack of a baseline questionnaire or validated assessment instrument limit broad applicability of these findings to large populations of patients with HL or sALCL. Conclusion This is the first report of BV PRO data in R/R HL and sALCL. Given the patients’ poor prognostic outcomes before stem cell transplant, these encouraging results warrant formal evaluation of PRO end points in BV trials. PMID:27103829

  17. The Establishment of the GENEQOL Consortium to Investigate the Genetic Disposition of Patient-Reported Quality-of-Life Outcomes

    PubMed Central

    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.

    2010-01-01

    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 GENEQOL Consortium, which intends to investigate the genetic disposition of patient-reported quality-of-life outcomes. We have identified five primary patient-reported quality-of-life outcomes as initial targets: negative psychological affect, positive psychological affect, self-rated physical health, pain, and fatigue. The first tangible objective of the GENEQOL Consortium is to develop a list of potential biological pathways, genes and genetic variants involved in these quality-of-life outcomes, by reviewing current genetic knowledge. The second objective is to design a research agenda to investigate and validate those genes and genetic variants of patient-reported quality-of-life outcomes, by creating large datasets. During its first meeting, the Consortium has discussed draft summary documents addressing these questions for each patient-reported quality-of-life outcome. A summary of the primary pathways and robust findings of the genetic variants involved is presented here. The research agenda outlines possible research objectives and approaches to examine these and new quality-of-life domains. Intriguing questions arising from this endeavor are discussed. Insight into the genetic versus environmental components of patient-reported quality-of-life outcomes will ultimately allow us to explore new pathways for improving patient care. If we can identify patients who are susceptible to poor quality of life, we will be able to better target specific clinical interventions to enhance their quality of life and treatment outcomes. PMID:19456223

  18. Patient-Reported Outcomes in Oncology Drug Labeling in the United States: A Framework for Navigating Early Challenges

    PubMed Central

    Shields, Alan L.; Hao, Yanni; Krohe, Meaghan; Yaworsky, Andrew; Mazar, Iyar; Foley, Catherine; Mehmed, Faisal; Globe, Denise

    2016-01-01

    Background Despite an increased use of patient-reported outcomes (PROs) in oncology clinical trials, integrating the patient perspective into drug approval decisions and documentation has been challenging. Objectives To review important regulatory and measurement terminology, and to provide oncology outcomes researchers and those involved with building oncology programs with tools to plan PRO data collection, particularly in relation to drug efficacy claims for drug labeling in the United States. Discussion When contemplating a PRO measurement strategy for oncology clinical trials, outcomes researchers are challenged in several ways. First, given multiple stakeholders, researchers must communicate with their scientific, commercial, and regulatory colleagues using often misunderstood terms, such as “label,” “claim,” “end point,” “outcome,” and “concept.” Second, because stakeholders do not always have access to data from early-stage clinical trials and do not contribute to the target drug's profile in early development, researchers are often unable to address the most important question in building a measurement strategy: What do we want to say about our drug? To overcome these challenges, researchers can systematically develop an end point model to facilitate communication among drug development stakeholders using a common language and to link the building blocks of a PRO measurement strategy, including claims, concepts, questionnaires, and end points. We developed a model that characterizes a disease by its proximal signs and/or symptoms and increasingly distal health outcomes to provide researchers potential measurement concepts that can be instrumental in selecting PRO questionnaires for use in studies. Conclusion PRO data collected in clinical trials should be used in drug development to evaluate the drug's efficacy; it is encouraging that US regulators are willing to work with drug sponsors to overcome the challenges associated with the

  19. Patient-Reported Outcomes in Oncology Drug Labeling in the United States: A Framework for Navigating Early Challenges

    PubMed Central

    Shields, Alan L.; Hao, Yanni; Krohe, Meaghan; Yaworsky, Andrew; Mazar, Iyar; Foley, Catherine; Mehmed, Faisal; Globe, Denise

    2016-01-01

    Background Despite an increased use of patient-reported outcomes (PROs) in oncology clinical trials, integrating the patient perspective into drug approval decisions and documentation has been challenging. Objectives To review important regulatory and measurement terminology, and to provide oncology outcomes researchers and those involved with building oncology programs with tools to plan PRO data collection, particularly in relation to drug efficacy claims for drug labeling in the United States. Discussion When contemplating a PRO measurement strategy for oncology clinical trials, outcomes researchers are challenged in several ways. First, given multiple stakeholders, researchers must communicate with their scientific, commercial, and regulatory colleagues using often misunderstood terms, such as “label,” “claim,” “end point,” “outcome,” and “concept.” Second, because stakeholders do not always have access to data from early-stage clinical trials and do not contribute to the target drug's profile in early development, researchers are often unable to address the most important question in building a measurement strategy: What do we want to say about our drug? To overcome these challenges, researchers can systematically develop an end point model to facilitate communication among drug development stakeholders using a common language and to link the building blocks of a PRO measurement strategy, including claims, concepts, questionnaires, and end points. We developed a model that characterizes a disease by its proximal signs and/or symptoms and increasingly distal health outcomes to provide researchers potential measurement concepts that can be instrumental in selecting PRO questionnaires for use in studies. Conclusion PRO data collected in clinical trials should be used in drug development to evaluate the drug's efficacy; it is encouraging that US regulators are willing to work with drug sponsors to overcome the challenges associated with the

  20. Development and psychometric evaluation of the FACE-Q satisfaction with appearance scale: a new patient-reported outcome instrument for facial aesthetics patients.

    PubMed

    Pusic, Andrea L; Klassen, Anne F; Scott, Amie M; Cano, Stefan J

    2013-04-01

    Satisfaction with appearance and improved quality of life are key outcomes for patients undergoing facial aesthetic procedures. The FACE-Q is a new patient-reported outcome (PRO) instrument encompassing a suite of independently functioning scales designed to measure a range of important outcomes for facial aesthetics patients. FACE-Q scales were developed with strict adherence to international guidelines for PRO instrument development. This article describes the development and psychometric evaluation of the core FACE-Q scale, the Satisfaction with Facial Appearance scale. Both modern and traditional psychometric methods were used to confirm that this new 10-item scale is a reliable, valid, and responsive measure.

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

    PubMed

    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. PMID:27002223

  2. A review of the most common patient-reported outcomes in COPD--revisiting current knowledge and estimating future challenges.

    PubMed

    Cazzola, Mario; Hanania, Nicola Alexander; MacNee, William; Rüdell, Katja; Hackford, Claire; Tamimi, Nihad

    2015-01-01

    Patient-reported outcome (PRO) measures that quantify disease impact have become important measures of outcome in COPD research and treatment. The objective of this literature review was to comprehensively evaluate psychometric properties of available PRO instruments and the ability of each of them to characterize pharmaceutical treatment effects from published clinical trial evidence. Identified in this study were several PRO measures, both those that have been used extensively in COPD clinical trials (St George's Respiratory Questionnaire and Chronic Respiratory Questionnaire) and new instruments whose full value is still to be determined. This suggests a great need for more information about the patient experience of treatment benefit, but this also may pose challenges to researchers, clinicians, and other important stakeholders (eg, regulatory agencies, pharmaceutical companies) who develop new treatment entities and payers (including but not limited to health technology assessment agencies such as the National Institute for Health and Care Excellence and the Canadian Agency for Drugs and Technologies in Health). The purpose of this review is to enable researchers and clinicians to gain a broad overview of PRO measures in COPD by summarizing the value and purpose of these measures and by providing sufficient detail for interested audiences to determine which instrument may be the most suitable for evaluating a particular research purpose.

  3. Patient-reported outcomes for US oncology labeling: review and discussion of score interpretation and analysis methods.

    PubMed

    Shields, Alan; Coon, Cheryl; Hao, Yanni; Krohe, Meaghan; Yaworsky, Andrew; Mazar, Iyar; Foley, Catherine; Globe, Denise

    2015-01-01

    This paper describes ways to approach the conceptual and practical challenges associated with interpreting the clinical meaning of scores produced by patient reported outcome (PRO) questionnaires, particularly when used to inform efficacy decisions for regulatory approval for oncology products. Score interpretation estimates are not inherent to PRO questionnaires per se, instead, vary dependent upon sample and study design characteristics. Scores from PRO measures can be interpreted at the individual and group level, and each carries its own set of statistics for evaluating differences. Oncology researchers have a variety of methods and data analytic strategies available to support their score interpretation needs, which should be considered in the context of their a priori knowledge of the target patient population, the hypothesized effects of treatment, the study design and assessment schedule, and the inferences and decisions to be made from the PRO data. PMID:26594897

  4. The Role of Technical Advances in the Adoption and Integration of Patient-Reported Outcomes in Clinical Care

    PubMed Central

    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

  5. [Pelargonium sidoides in acute bronchitis - Health-related quality of life and patient-reported outcome in adults receiving EPs 7630 treatment].

    PubMed

    Matthys, Heinrich; Lizogub, Victor G; Funk, Petra; Malek, Fathi A

    2010-12-01

    Health-related quality of life (HRQL) and patient-reported outcome (PRO) have become important outcome parameters for the evaluation of medical treatment within clinical trials and, furthermore, to evaluate efficiency in clinical practice. We therefore report further exploratory results of an already reported dose-finding study with EPs 7630 tablets, now focussing on HRQL and PRO. A total of 406 adults with acute bronchitis were randomly assigned to one of four parallel treatment groups (placebo, 30 mg, 60 mg or 90 mg EPs 7630 daily). HRQL and PRO were assessed by questionnaires as secondary outcome measures at each study visit or daily in the patient's diary. At day 7, the patient-reported outcome measures were significantly more improved in all the three EPs 7630 groups compared to placebo (EQ-5D and EQ VAS, SF-12: physical score, impact of patient's sickness, duration of activity limitation, patient-reported treatment outcome, satisfaction with treatment). In conclusion, a statistically significant and clinically relevant improvement of HRQL/PRO compared to placebo was shown in all the three EPs 7630 groups.

  6. Why Measure Outcomes?

    PubMed

    Kuhn, John E

    2016-01-01

    The concept of measuring the outcomes of treatment in health care was promoted by Ernest Amory Codman in the early 1900s, but, until recently, his ideas were generally ignored. The forces that have advanced outcome measurement to the forefront of health care include the shift in payers for health care from the patient to large insurance companies or government agencies, the movement toward assessing the care of populations not individuals, and the effort to find value (or cost-effective treatments) amid rising healthcare costs. No ideal method exists to measure outcomes, and the information gathered depends on the reason the outcome information is required. Outcome measures used in research are best able to answer research questions. The methods for assessing physician and hospital performance include process measures, patient-experience measures, structure measures, and measures used to assess the outcomes of treatment. The methods used to assess performance should be validated, be reliable, and reflect a patient's perception of the treatment results. The healthcare industry must measure outcomes to identify which treatments are most effective and provide the most benefit to patients. PMID:27049223

  7. Patient-reported outcomes 3 months after spine surgery: is it an accurate predictor of 12-month outcome in real-world registry platforms?

    PubMed

    Parker, Scott L; Asher, Anthony L; Godil, Saniya S; Devin, Clinton J; McGirt, Matthew J

    2015-12-01

    OBJECT The health care landscape is rapidly shifting to incentivize quality of care rather than quantity of care. Quality and outcomes registry platforms lie at the center of all emerging evidence-driven reform models and will be used to inform decision makers in health care delivery. Obtaining real-world registry outcomes data from patients 12 months after spine surgery remains a challenge. The authors set out to determine whether 3-month patient-reported outcomes accurately predict 12-month outcomes and, hence, whether 3-month measurement systems suffice to identify effective versus noneffective spine care. METHODS All patients undergoing lumbar spine surgery for degenerative disease at a single medical institution over a 2-year period were enrolled in a prospective longitudinal registry. Patient-reported outcome instruments (numeric rating scale [NRS], Oswestry Disability Index [ODI], 12-Item Short Form Health Survey [SF-12], EQ-5D, and the Zung Self-Rating Depression Scale) were recorded prospectively at baseline and at 3 months and 12 months after surgery. Linear regression was performed to determine the independent association of 3- and 12-month outcome. Receiver operating characteristic (ROC) curve analysis was performed to determine whether improvement in general health state (EQ-5D) and disability (ODI) at 3 months accurately predicted improvement and achievement of minimum clinical important difference (MCID) at 12 months. RESULTS A total of 593 patients undergoing elective lumbar surgery were included in the study. There was a significant correlation between 3-month and 12-month EQ-5D (r = 0.71; p < 0.0001) and ODI (r = 0.70; p < 0.0001); however, the authors observed a sizable discrepancy in achievement of a clinically significant improvement (MCID) threshold at 3 versus 12 months on an individual patient level. For postoperative disability (ODI), 11.5% of patients who achieved an MCID threshold at 3 months dropped below this threshold at 12 months; 10

  8. The impact of newer atypical antipsychotics on patient-reported outcomes in schizophrenia.

    PubMed

    Awad, A George; Voruganti, Lakshmi N P

    2013-08-01

    Over the past two decades there has been increasing interest in including patients' self-reports in the management of their illness. Among the many reasons for such recent interest has been a rising consumer movement over the past few decades, which has led patients, their caregivers and their families to press for more meaningful sharing with physicians in the clinical decision-making process, with the clear expectations of better therapies and improved outcomes. Patients as consumers of services, their views, attitudes towards healthcare, as well as their level of satisfaction with care, have become increasingly recognized. The recent interest by the US Food and Drug Administration (FDA), as well as other regulatory agencies, in patient-reported outcomes (PROs) in the process of developing and testing new antipsychotics, has also added more impetus. It is clear that including patients in the decision-making process about the management of their psychiatric conditions also broadens the concept of 'recovery', by empowering patients to be active participants and gives a clear message that successful treatment in schizophrenia is more than a symptomatic improvement, but also includes improved functional status. Additionally, the recent interest in personalized medicine puts the patient in the centre of such development. Since 2004, when we published our review about the impact of new antipsychotics on quality of life in CNS Drugs, a number of newer antipsychotics have been introduced and include ziprasidone, aripiprazole, paliperidone, asenapine, iloperidone and lurasidone. The current review is based on 31 selected publications that cover the years 2004-2012, and deals with the impact of such newer antipsychotics on specific domains of PROs, such as subjective tolerability, quality of life, medication preference, satisfaction and social functioning. Most of the available data deal with ziprasidone, aripiprazole and paliperidone. Though the great majority of the

  9. Impact of genomic testing and patient-reported outcomes on receipt of adjuvant chemotherapy.

    PubMed

    Evans, Chalanda N; Brewer, Noel T; Vadaparampil, Susan T; Boisvert, Marc; Ottaviano, Yvonne; Lee, M Catherine; Isaacs, Claudine; Schwartz, Marc D; O'Neill, Suzanne C

    2016-04-01

    Practice guidelines incorporate genomic tumor profiling, using results such as the Oncotype DX Recurrence Score (RS), to refine recurrence risk estimates for the large proportion of breast cancer patients with early-stage, estrogen receptor-positive disease. We sought to understand the impact of receiving genomic recurrence risk estimates on breast cancer patients' well-being and the impact of these patient-reported outcomes on receipt of adjuvant chemotherapy. Participants were 193 women (mean age 57) newly diagnosed with early-stage breast cancer. Women were interviewed before and 2-3 weeks after receiving the RS result between 2011 and 2015. We assessed subsequent receipt of chemotherapy from chart review. After receiving their RS, perceived pros (t = 4.27, P < .001) and cons (t = 8.54, P < .001) of chemotherapy increased from pre-test to post-test, while perceived risk of breast cancer recurrence decreased (t = 2.90, P = .004). Women with high RS tumors were more likely to receive chemotherapy than women with low RS tumors (88 vs. 5 %, OR 0.01, 0.00-0.02, P < .001). Higher distress (OR 2.19, 95 % CI 1.05-4.57, P < .05) and lower perceived cons of chemotherapy (OR 0.50, 95 % CI 0.26-0.97, P < .05) also predicted receipt of chemotherapy. Distressed patients who saw few downsides of chemotherapy received this treatment. Clinicians should consider these factors when discussing chemotherapy with breast cancer patients. PMID:27059031

  10. Collecting Patient-Reported Outcomes: Lessons from the California Joint Replacement Registry

    PubMed Central

    Chenok, Kate; Teleki, Stephanie; SooHoo, Nelson F.; Huddleston, James; Bozic, Kevin J.

    2015-01-01

    Context: While patient-reported outcomes (PROs) have long been used for research, recent technology advancements make it easier to collect patient feedback and use it for patient care. Despite the promise and appeal of PROs, substantial barriers to widespread adoption remain—including challenges in interpreting privacy regulations, educating patients and physicians about the power that PRO collection can provide to patient-centered care. Case Description: This article describes lessons learned from the California Joint Replacement Registry’s (CJRR) five-year effort to collect PROs from patients undergoing total hip and total knee replacement surgeries. CJRR is a voluntary, multi-institutional registry in California that collects clinical and device information, as well as PROs from patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA) surgeries. Proposed Solutions: The CJRR encountered and developed solutions to overcome several key issues: (1) limitations of electronic PRO collection, (2) challenges in patient recruitment and tracking, (3) challenges in encouraging patients to complete PRO surveys, (4) real and perceived administrative burden to clinic and hospital staff, (5) surgeon engagement, and (6) survey costs. Conclusion: The CJRR’s field experience can inform growing numbers of providers and researchers who seek to more fully understand the impact of care from the patient’s perspective. In addition, the authors believe that these challenges can best be addressed through a combination of policy changes and increased incentives. PMID:26793737

  11. Measurement of Training Outcomes.

    ERIC Educational Resources Information Center

    Bond, Nicholas A., Jr.; Rigney, Joseph W.

    Measurement of training outcomes is a requirement for evaluating new training techniques, but is one that is different to meet. Managers of education and training may have different concepts of what they want, as favorable outcomes, than do the investigators doing the research. Classical statistical and experimental designs assume laboratory rigor…

  12. Measuring Course Learning Outcomes

    ERIC Educational Resources Information Center

    Keshavarz, Mohsen

    2011-01-01

    Accreditation criteria of programs require effective learning outcomes, assessment with documented procedures, tools, results, and actions to close the assessment loop with broad faculty involvement. This article describes a methodology for providing quantitative measurement of a course's learning outcomes. The methodology uses a linkage matrix…

  13. Segmental mobility, disc height and patient-reported outcomes after surgery for degenerative disc disease: a prospective randomised trial comparing disc replacement and multidisciplinary rehabilitation.

    PubMed

    Johnsen, L G; Brinckmann, P; Hellum, C; Rossvoll, I; Leivseth, G

    2013-01-01

    This prospective multicentre study was undertaken to determine segmental movement, disc height and sagittal alignment after total disc replacement (TDR) in the lumbosacral spine and to assess the correlation of biomechanical properties to clinical outcomes.A total of 173 patients with degenerative disc disease and low back pain for more than one year were randomised to receive either TDR or multidisciplinary rehabilitation (MDR). Segmental movement in the sagittal plane and disc height were measured using distortion compensated roentgen analysis (DCRA) comparing radiographs in active flexion and extension. Correlation analysis between the range of movement or disc height and patient-reported outcomes was performed in both groups. After two years, no significant change in movement in the sagittal plane was found in segments with TDR or between the two treatment groups. It remained the same or increased slightly in untreated segments in the TDR group and in this group there was a significant increase in disc height in the operated segments. There was no correlation between segmental movement or disc height and patient-reported outcomes in either group.In this study, insertion of an intervertebral disc prosthesis TDR did not increase movement in the sagittal plane and segmental movement did not correlate with patient-reported outcomes. This suggests that in the lumbar spine the movement preserving properties of TDR are not major determinants of clinical outcomes.

  14. Introduction to patient-reported outcome item banks: issues in minority aging research.

    PubMed

    Templin, Thomas N; Hays, Ron D; Gershon, Richard C; Rothrock, Nan; Jones, Richard N; Teresi, Jeanne A; Stewart, Anita; Weech-Maldonado, Robert; Wallace, Steve

    2013-04-01

    Pre-Conference Workshop in conjunction with the Annual Meeting of the Geriatrics Society of America San Diego Convention Center, San Diego, CA, USA, 14 November 2012 In 2004, the NIH awarded contracts to initiate the development of high-quality psychological and neuropsychological outcome measures for the improved assessment of health-related outcomes. The workshop introduced these measurement development initiatives, the measures created and the NIH-supported resource (Assessment Center) for internet or tablet-based test administration and scoring. Presentations covered item response theory and assessment of test bias, construction of item banks and computerized adaptive testing, and the different ways in which qualitative analyses contribute to the definition of construct domains and the refinement of outcome constructs. The panel discussion included questions about representativeness of samples and the assessment of cultural bias. PMID:23570428

  15. Patient-reported outcomes: pathways to better health, better services, and better societies.

    PubMed

    Black, N; Burke, L; Forrest, C B; Sieberer, U H Ravens; Ahmed, S; Valderas, J M; Bartlett, S J; Alonso, J

    2016-05-01

    While the use of PROs in research is well established, many challenges lie ahead as their use is extended to other applications. There is consensus that health outcome evaluations that include PROs along with clinician-reported outcomes and administrative data are necessary to inform clinical and policy decisions. The initiatives presented in this paper underline evolving recognition that PROs play a unique role in adding the patient perspective alongside clinical (e.g., blood pressure) and organizational (e.g., admission rates) indicators for evaluating the effects of new products, selecting treatments, evaluating quality of care, and monitoring the health of the population. In this paper, we first explore the use of PRO measures to support drug approval and labeling claims. We critically evaluate the evidence and challenges associated with using PRO measures to improve healthcare delivery at individual and population levels. We further discuss the challenges associated with selecting from the abundance of measures available, opportunities afforded by agreeing on common metrics for constructs of interest, and the importance of establishing an evidence base that supports integrating PRO measures across the healthcare system to improve outcomes. We conclude that the integration of PROs as a key end point within individual patient care, healthcare organization and program performance evaluations, and population surveillance will be essential for evaluating whether increased healthcare expenditure is translating into better health outcomes. PMID:26563251

  16. The relationship between pain severity and patient-reported outcomes among patients with chronic low back pain in Japan

    PubMed Central

    Montgomery, William; Vietri, Jeffrey; Shi, Jing; Ogawa, Kei; Kariyasu, Sawako; Alev, Levent; Nakamura, Masaya

    2016-01-01

    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, and more health care provider visits (all P<0.0001). Conclusion The impact of chronic low back pain on health-related quality of life, depression and anxiety symptoms, impairment to work and daily activities, and health care use increases with the severity of pain. Interventions reducing the severity of pain may improve numerous health outcomes even if the pain cannot be eliminated. PMID:27330326

  17. Current Trends in the Use of Patient-Reported Outcome Instruments in Degenerative Cervical Spine Surgery

    PubMed Central

    Ueda, Haruki; Cutler, Holt S.; Guzman, Javier Z.; Cho, Samuel K.

    2015-01-01

    Study Design Bibliometric analysis. Objective To determine trends, frequency, and distribution of patient-reported outcome instruments (PROIs) in degenerative cervical spine surgery literature over the past decade. Methods A search was conducted via PubMed from 2004 to 2013 on five journals (The Journal of Bone and Joint Surgery, The Bone and Joint Journal, The Spine Journal, European Spine Journal, and Spine), which were chosen based on their impact factors and authors' consensus. All abstracts were screened and articles addressing degenerative cervical spine surgery using PROIs were included. Articles were then analyzed for publication date, study design, journal, level of evidence, and PROI trends. Prevalence of PROIs and level of evidence of included articles were analyzed. Results From 19,736 articles published, 241 articles fulfilled our study criteria. Overall, 53 distinct PROIs appeared. The top seven most frequently used PROIs were: Japanese Orthopaedic Association score (104 studies), visual analog scale for pain (100), Neck Disability Index (72), Short Form-36 (38), Nurick score (25), Odom criteria (21), and Oswestry Disability Index (15). Only 11 PROIs were used in 5 or more articles. Thirty-three of the PROIs were appeared in only 1 article. Among the included articles, 16% were of level 1 evidence and 32% were of level 4 evidence. Conclusion Numerous PROIs are currently used in degenerative cervical spine surgery. A consensus on which instruments to use for a given diagnosis or procedure is lacking and may be necessary for better communication and comparison, as well as for the accumulation and analysis of vast clinical data across multiple studies. PMID:27099815

  18. Communicating the results of randomized clinical trials: do patients understand multidimensional patient-reported outcomes?

    PubMed

    McNair, Angus G K; Brookes, Sara T; Davis, Christopher R; Argyropoulos, Miltiadis; Blazeby, Jane M

    2010-02-10

    PURPOSE Evidence suggests that patient-reported outcomes (PROs) from randomized trials in oncology may not influence clinical decision making and patient choice. Reasons for this are currently unclear and little is known about patients' interpretation of PROs. This study assessed patients' understanding of multidimensional PROs in a graphical format. PATIENTS AND METHODS Semistructured interviews in which patients interpreted a series of graphs depicting simple, then multiple different hypothetical PROs associated with two treatments with identical chances of survival were audio recorded. The interviewer and a blinded observer (listening to audio recordings) scored patients' understanding of the graphs. Logistic regression examined the associations between patient understanding of the graphs and clinical and sociodemographic details. Results One hundred thirty-two patients with esophageal and gastric cancer were interviewed and 115 understood the first two graphs depicting different PROs of two treatments (87%; 95% CI,81 to 93). Simultaneous interpretation of adverse and beneficial treatment effects was achieved by 74 (66%; 95% CI, 57 to 75). Graphs showing complex, longitudinal data were correctly interpreted by 97 (73%; 95% CI, 66 to 81) and 108 (81%; 95% CI, 75 to 88), respectively. Univariable analyses demonstrated associations between patient understanding and patient age, educational level, and cancer site (P < or = .02 for all); however, in a multivariable model each of these associations was attenuated. CONCLUSION Most patients understand graphical multidimensional PROs, although a smaller majority were able to interpret more complex, or simultaneous, presentations. Additional work is needed to define methods for communicating clinical and PRO data from trials to allow patients to make informed treatment choices. PMID:20065187

  19. Comparative Effectiveness of Etanercept and Adalimumab in Patient Reported Outcomes and Injection-Related Tolerability

    PubMed Central

    Navarro-Millán, Iris; Herrinton, Lisa J.; Chen, Lang; Harrold, Leslie; Liu, Liyan; Curtis, Jeffrey R.

    2016-01-01

    Objective To describe patient preferences in selecting specific biologics and compare clinical response using patient reported outcomes (PROs) among patients with rheumatoid arthritis (RA) started on different anti-tumor necrosis factor (TNF) therapies. Methods Participants were enrollees in Kaiser Permanente Northern California. Patients with RA who had at least two provider visits and started a new anti-TNF therapy from 10/2010–8/2011, were eligible for participation in this longitudinal study. Using a telephone survey, patient preferences in biologic selection and RAPID3, MDHAQ, and SF-12 scores were collected at baseline and at 6 months. Patient scores rating injection/infusion-site burning and stinging (ISBS) were collected at 6 months. Results In all, 267 patients with RA responded to the baseline survey, of whom 57% preferred an injectable biologic, 22% preferred an infused biologic, and 21% had no preference. Motivation for injectable biologics was convenience (92%) and for infusion therapy was dislike or lack of self-efficacy for self-injection (16%). After 6 months of treatment with anti-TNF, 70% of the 177 patients who answered the ISBS question reported ISBS with the last dose; on a scale of 1 (none) to 10 (worst), 41% of these reported a score of 2–5; and 29% reported a score of 6–10. Adalimumab users experienced 3.2 times (95% confidence interval 1.2–8.6) the level of ISBS that etanercept users experienced. There were no significant differences in RAPID3, MDHAQ, or SF-12 scores between etanercept or adalimumab initiators. Conclusion Convenience and fear of self-injection were important considerations to patients selecting a biologic drug. Although more convenient, adalimumab associated with more ISBS than did etanercept, and this rate was higher than reported in clinical trials. At 6 months, PROs did not differ between etanercept and adalimumab users. PMID:27007811

  20. A Novel Digital Patient-Reported Outcome Platform for Head and Neck Oncology Patients—A Pilot Study

    PubMed Central

    Peltola, Maria K.; Lehikoinen, Joel S.; Sippola, Lauri T.; Saarilahti, Kauko; Mäkitie, Antti A.

    2016-01-01

    INTRODUCTION The patient’s role in toxicity reporting is increasingly acknowledged. There is also a need for developing modern communication methods between the patient and the medical personnel. Furthermore, the increasing number of head and neck cancer (HNC) patients is reflected in the volume of treatment follow-up visits, which remains a challenge for the health care. Electronic patient-reported outcome (ePRO) measures may provide a cost-efficient way to organize follow-up for cancer patients. MATERIALS AND METHODS We tested a novel ePRO application called Kaiku®, which enables real-time, online collection of patient-reported outcomes, such as side effects caused by treatment and quality of life. We conducted a pilot study to assess the suitability of Kaiku® for HNC patients at the Department of Oncology, Helsinki University Hospital, Helsinki, Finland. Patients used Kaiku® during and one month after radiotherapy to report treatment-related side effects and quality of life. Two physicians and a nurse performed the practical electronic communication part of the study. RESULTS Five of the nine patients agreed to participate in the study: three of them had local early-stage larynx cancer (T2N0, T1aN0, and T2N0) and the remaining two patients had early-stage base of tongue cancer (T2N0 and T1N2b). The degree of side effects reported by the patients via Kaiku® ranged from mild to life threatening. The number of outcome data points on patients’ progress was significantly increased, which resulted in a better follow-up and improved communication between the patient and the care team. CONCLUSIONS Kaiku® seems to be a suitable tool to monitor side effects and quality of life during and after radiotherapy among HNC patients. Kaiku® and similar tools could be useful in organizing a cost-effective follow-up process for HNC patients. We recommend conducting a larger study to further assess the impact of an ePRO solution in routine clinical practice. ePRO solutions

  1. Patient-reported outcomes of caries prophylaxis among Swedish caries active adults in a long-term perspective.

    PubMed

    Flink, Håkan; Tegelberg, Åke; Arnetz, Judy; Birkhed, Dowen

    2016-01-01

    The aim of this study was to measure patient-reported outcomes of caries prophylaxis and to compare them with previously documented efforts in dental offices. A questionnaire was mailed to 134 caries active (CA) and 40 caries inactive (CI) adult patients treated at a Swedish public dental service clinic. The overall response rate was 69%. The questionnaire included items regarding patient perceived caries prophylaxis in relation to: 1) treatment and recommendations given by the dental personnel, 2) performed self-care and 3) perceived and expected effects.The responses were studied for their association to clinical data, extracted retrospectively from the patients' dental records.The mean follow up time was > 16 years. Information about caries prophylaxis (p = 0.01) and recommendations for self-care (p = 0.04) were given more often to the CA group than to the CI group. Supplementary examinations and recommendations of self-care risk treatments were more frequent in the CA group (p < 0.001). CA patients also made more frequent extra efforts at home to avoid caries by changing their eating habits (p < 0.001), improving their oral hygiene (p = 0.04) and using extra fluoride (p = 0.001). In the CA group, 60% did not considerthat the extra prophylaxis efforts had made them caries inactive, and 40% were not satisfied with the outcome. Most patients (> 90%) hoped that the outcome of caries prophylactics would be a reduced number of cavities.The patient-perceived experiences of caries prophylaxis-were in concordance with dental records. Both the dentists and the caries active middle-aged Swedish adults were aware of the need for extra prophylaxis.The caries active patients perceived having made extra home care efforts, but had not experienced that they had become free from caries. PMID:27464386

  2. The Impact of Obesity on Patient Reported Outcomes Following Stereotactic Body Radiation Therapy for Prostate Cancer

    PubMed Central

    Cyr, Robyn; Feng, Li Rebekah; Bae, Edward; Danner, Malika T; Ayoob, Marilyn; Yung, Thomas M; Lei, Siyuan; Collins, Brian T; Saligan, Leorey; Simeng, Suy; Kumar, Deepak; Collins, Sean P

    2016-01-01

    Objectives The relationship between obesity (Body Mass Index ­>30 kg/m2) and quality of life (QoL) following prostate cancer (PCa) radiation therapy (RT) is unknown. Excess abdominal fat may compromise the precise delivery of radiation, putting surrounding organs at risk for greater radiation exposure. Stereotactic body radiation therapy (SBRT) utilizes a real-time tracking system that provides updated prostate position information and allows for correction of the therapeutic beam during treatment with high accuracy. In this study, we evaluate the impact of obesity on patient reported outcomes following SBRT for prostate cancer. Materials and methods Between February 2008 and April 2012, 88 obese and 178 non-obese patients with PCa were treated with SBRT at Georgetown University Hospital, Washington, DC. Health-related quality of life (HRQol) was assessed via the expanded prostate cancer index composite (EPIC)-26 at baseline, 6, 12, 18, and 24 months after 5-fraction delivery of 35-36.25 Gy with the CyberKnife. Patients who received androgen deprivation therapy (ADT) were excluded from this analysis due to its known negative impact on HRQoL. Results Pretreatment characteristics of obese and non-obese patient groups were similar except that obese patients had lower total testosterone levels. Urinary and bowel function and bother scores between the two patient cohorts were comparable at baseline and subsequent follow-ups. Sexual function and bother were also similar at baseline between both groups. Bother was defined by displeasure patients may experience from functional decline. At 24 months post-SBRT, obese men experienced borderline clinically significant decrease in sexual function and greater sexual bother compared to non-obese patients. Fatigue was significantly higher in obese patients compared to non-obese patients at 18 months post-SBRT. Conclusions Prostate SBRT affects obese and non-obese patients similarly in total HRQoL scores and majority of its

  3. Patient-reported Outcomes in Asian Patients With Chronic Hepatitis C Treated With Ledipasvir and Sofosbuvir

    PubMed Central

    Younossi, Zobair M.; Stepanova, Maria; Chan, Henry L.Y.; Lee, Mei H.; Yu, Ming-Lung; Dan, Yock Y.; Choi, Moon S.; Henry, Linda

    2016-01-01

    Abstract Prevalence of chronic hepatitis C (CH-C) infection in patients of Asian ancestry ranges between 1% and 20%. Interferon (IFN)- and ribavirin (RBV)-containing regimens for CH-C have a negative impact on patient-reported outcomes (PROs) during treatment. The aim of this study was to assess the impact of IFN-free RBV-free sofosbuvir (SOF)-based regimens on PROs in CH-C patients of Asian ancestry. In this observational retrospective study, the PRO data from 12 multicenter multinational phase 3 clinical trials (2012–2015, conducted in Europe, North America, Australia, and New Zealand) of SOF-based regimens with and without IFN, ledipasvir (LDV), and/or RBV were used. At baseline, during treatment, and post-treatment, patients completed 4 validated PRO questionnaires (SF-36, CLDQ-HCV, FACIT-F, and WPAI:SHP). The resulting PROs in Asian patients were compared across the treatment regimens. Of 4485 of the trials’ participants, 106 patients were of Asian ancestry (55.7% male, 69.8% treatment-naïve, 17.0% cirrhotic). In comparison with other patients, the Asian CH-C cohort was younger, had lower BMI, and lower rates of pre-treatment psychiatric comorbidities (anxiety, depression, sleep disorders) (all P < .05). At baseline, Asian patients also had lower SF-36 physical functioning scores (on average, by −5.6% on a normalized 0–100% PRO scale, P = .001). During treatment, Asian CH-C patients experienced a decline in their PRO scores while receiving IFN and/or RBV-containing regimens (up to −19.6%, P < .001). In contrast, patients receiving LDV/SOF experienced no PRO decrement and improvement of some PRO scores during treatment (+9.0% in general health of SF-36, P = .03). After achieving SVR-12, some of the PRO scores in Asian patients improved regardless of the regimen (up to +9.3%, P < .001). In multivariate analysis of Asian patients, the use of LDV/SOF was independently associated with higher PRO scores during and soon after the end of

  4. Evaluating more naturalistic outcome measures

    PubMed Central

    Bove, Riley; White, Charles C.; Giovannoni, Gavin; Glanz, Bonnie; Golubchikov, Victor; Hujol, Johnny; Jennings, Charles; Langdon, Dawn; Lee, Michelle; Legedza, Anna; Paskavitz, James; Prasad, Sashank; Richert, John; Robbins, Allison; Roberts, Susan; Weiner, Howard; Ramachandran, Ravi; Botfield, Martyn

    2015-01-01

    Objective: In this cohort of individuals with and without multiple sclerosis (MS), we illustrate some of the novel approaches that smartphones provide to monitor patients with chronic neurologic disorders in their natural setting. Methods: Thirty-eight participant pairs (MS and cohabitant) aged 18–55 years participated in the study. Each participant received an Android HTC Sensation 4G smartphone containing a custom application suite of 19 tests capturing participant performance and patient-reported outcomes (PROs). Over 1 year, participants were prompted daily to complete one assigned test. Results: A total of 22 patients with MS and 17 cohabitants completed the entire study. Among patients with MS, low scores on PROs relating to mental and visual function were associated with dropout (p < 0.05). We illustrate several novel features of a smartphone platform. First, fluctuations in MS outcomes (e.g., fatigue) were assessed against an individual's ambient environment by linking responses to meteorological data. Second, both response accuracy and speed for the Ishihara color vision test were captured, highlighting the benefits of both active and passive data collection. Third, a new trait, a person-specific learning curve in neuropsychological testing, was identified using spline analysis. Finally, averaging repeated measures over the study yielded the most robust correlation matrix of the different outcome measures. Conclusions: We report the feasibility of, and barriers to, deploying a smartphone platform to gather useful passive and active performance data at high frequency in an unstructured manner in the field. A smartphone platform may therefore enable large-scale naturalistic studies of patients with MS or other neurologic diseases. PMID:26516627

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

    PubMed Central

    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

    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 these measures

  6. A systematic review of patient-reported measures of burden of treatment in three chronic diseases

    PubMed Central

    Eton, David T; Elraiyah, Tarig A; Yost, Kathleen J; Ridgeway, Jennifer L; Johnson, Anna; Egginton, Jason S; Mullan, Rebecca J; Murad, Mohammad Hassan; Erwin, Patricia J; Montori, Victor M

    2013-01-01

    Background Burden of treatment refers to the workload of health care and its impact on patient functioning and well-being. There are a number of patient-reported measures that assess burden of treatment in single diseases or in specific treatment contexts. A review of such measures could help identify content for a general measure of treatment burden that could be used with patients dealing with multiple chronic conditions. We reviewed the content and psychometric properties of patient-reported measures that assess aspects of treatment burden in three chronic diseases, ie, diabetes, chronic kidney disease, and heart failure. Methods We searched Ovid MEDLINE, Ovid EMBASE, Ovid PsycINFO, and EBSCO CINAHL through November 2011. Abstracts were independently reviewed by two people, with disagreements adjudicated by a third person. Retrieved articles were reviewed to confirm relevance, with patient-reported measures scrutinized to determine consistency with the definition of burden of treatment. Descriptive information and psychometric properties were extracted. Results A total of 5686 abstracts were identified from the database searches. After abstract review, 359 full-text articles were retrieved, of which 76 met our inclusion criteria. An additional 22 articles were identified from the references of included articles. From the 98 studies, 57 patient-reported measures of treatment burden (full measures or components within measures) were identified. Most were multi-item scales (89%) and assessed treatment burden in diabetes (82%). Only 15 measures were developed using direct patient input and had demonstrable evidence of reliability, scale structure, and multiple forms of validity; six of these demonstrated evidence of sensitivity to change. We identified 12 content domains common across measures and disease types. Conclusion Available measures of treatment burden in single diseases can inform derivation of a patient-centered measure of the construct in patients with

  7. Patient-Centered Care and Patient-Reported Measures: Let's Look Before We Leap.

    PubMed

    Miller, Daniel; Steele Gray, Carolyn; Kuluski, Kerry; Cott, Cheryl

    2015-08-01

    This commentary focuses on patient-reported measures as tools to support patient-centered care for patients with multiple chronic conditions (MCCs). We argue that those using patient-reported measures in care management or evaluation of services for MCC patients should do so in recognition of the challenges involved in treating them. MCC patient care is challenging because (1) it is difficult to specify the causes of particular symptoms; (2) assessment of many important symptoms relies on subjective report; and (3) patients require care from a variety of providers. Due to the multiple domains of health affected in single individuals, and the large variation in needs, care that is holistic and individualized (i.e. patient-centered) is appropriate for MCC patients. However, due to the afore-mentioned challenges, it is important to carefully consider what this care entails and how practical contexts shape it. Patient-centered care for MCC patients implies continuous, dialogic patient-provider relationships, and the formulation of coherent and adaptive multi-disciplinary care protocols. We identify two broadly defined contextual influences on the nature and quality of these processes and their outputs: (1) busy practice settings and (2) fragmented information technology. We then identify several consequences that may result from inattention to these contextual influences upon introduction of patient-reported measure applications. To maximize the benefits, and minimize the harms of patient-reported measure use, we encourage policy makers and providers to attend carefully to these and other important contextual factors before, during and after the introduction of patient-reported measure initiatives.

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

    SciTech Connect

    Gilbert, Alexandra; Ziegler, Lucy; Martland, Maisie; Davidson, Susan; Efficace, Fabio; Sebag-Montefiore, David; Velikova, Galina

    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

  9. [Patient evaluation and outcome measures].

    PubMed

    Nieto Pol, Enrique

    2014-01-01

    Both the initial evaluation and follow-up of patients with osteoarthritis require systematic evaluation of the indicators that provide information on the degree of involvement of the disease and allow its quantification. Reliable measures of disease progression help decision-making by clinicians and provide valid information on treatment response and the effectiveness of the distinct therapeutic interventions. The instruments recommended in research, as outcome measures in osteoarthritis, are pain evaluation, assessment of physical function, and self-reported global evaluation. In studies lasting more than 1 year, structural changes are evaluated through simple X-ray. Self-reported quality of life assessment and physician global assessment are also recommended as options. These indicators should be incorporated into routine clinical practice for adequate evaluation and correct follow-up of patients with osteoarthritis. The recommended pain evaluation method for use in clinical practice is the visual analog scale (VAS). The best instrument to evaluate physical function in patients with hip or knee osteoarthritis is the WOMAC scale (Western Ontario and McMaster Universities Osteoarthritis Index). For patient-reported global assessment in routine practice, the recommended scales are VAS or the SF-12 (12-item short-form health survey).

  10. Relationship between clinical and patient-reported outcomes in a phase 3 trial of tofacitinib or MTX in MTX-naïve patients with rheumatoid arthritis

    PubMed Central

    Fleischmann, Roy; Strand, Vibeke; Wilkinson, Bethanie; Kwok, Kenneth; Bananis, Eustratios

    2016-01-01

    Objective To compare the relationship between clinical measures and patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA) treated with tofacitinib or methotrexate (MTX). Methods In a phase 3 randomised controlled trial, patients (N=956) who were MTX-naïve or had received ≤3 doses were randomised and received tofacitinib 5 or 10 mg twice daily or MTX titrated to 20 mg/week. Outcomes included: per cent of patients achieving American College of Rheumatology 70% responses (ACR70), ACR50, low disease activity (LDA) by Simplified Disease Activity Index (SDAI ≤11) and Clinical Disease Activity Index (CDAI ≤10), remission by SDAI (≤3.3) and CDAI (≤2.8), patient-reported Health Assessment Questionnaire-Disability Index (HAQ-DI scores <0.5), pain and global assessment of disease activity. Results At month 6, most patients who achieved LDA/remission by one definition achieved LDA/remission with others; however, discordance between measures was greater with MTX than with tofacitinib. As expected, concordance between CDAI and SDAI responses was high. Overall, patients achieving LDA or ACR50 responses reported less improvement in PROs (HAQ-DI, pain and patient global assessment) compared with clinical measures (tender and swollen joint counts). Conclusions Variability in levels of responses between clinical outcomes and PROs should be considered when setting treat-to-target goals in patients with RA. Trial registration number NCT01039688; Post-results. PMID:27175296

  11. The impact of the new antiviral regimens on patient reported outcomes and health economics of patients with chronic hepatitis C.

    PubMed

    Younossi, Zobair; Henry, Linda

    2014-12-15

    Hepatitis C is an important cause of chronic liver disease worldwide with an estimated 170 million people infected. Hepatitis C virus (HCV)-infected patients are physically and mentally impacted by fatigue, depression and anxiety causing an impairment of health related quality of life (HRQOL), lower worker productivity and other patient reported outcomes (PROs). Although anti-HCV regimens containing first generation direct acting antiviral agents (DAAs) were associated with significant side effects, the second generation DAAs, sofosbuvir (SOF) and simeprevir (SMV), are associated with fewer side effects, better tolerability and high cure rates. Despite these advantages, key stakeholders are currently trying to find ways to best integrate these new therapeutic regimens into the management of patients with chronic hepatitis C for the benefit of all. The purpose of this article is to offer insight into the other key and equally important outcomes (PRO's, HRQOL and cost) which should be considered when assessing the applicability of these new regimens for the care of patients infected with HCV. Our review provides evidence that the new treatment regimens for HCV not only have high efficacy rates but are also associated with better patient reported outcomes and cost per case of HCV cured. Additionally, compared to other medical interventions, these new regimens are cost-effective from a societal perspective.

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

    PubMed

    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.

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

    PubMed Central

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

    2016-01-01

    Objective. To evaluate effects of tofacitinib or adalimumab on patient-reported outcomes (PROs) in patients with moderate to severe RA and inadequate responses to MTX. Methods. 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). Results. 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 < 0.05). Changes from baseline at month 3 with 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. Conclusion. 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. PMID:26929445

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

    PubMed

    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.

  15. Recommended patient-reported core set of symptoms to measure in prostate cancer treatment trials.

    PubMed

    Chen, Ronald C; Chang, Peter; Vetter, Richard J; Lukka, Himansu; Stokes, William A; Sanda, Martin G; Watkins-Bruner, Deborah; Reeve, Bryce B; Sandler, Howard M

    2014-07-01

    The National Cancer Institute (NCI) Symptom Management and Health-Related Quality of Life Steering Committee convened four working groups to recommend core sets of patient-reported outcomes to be routinely incorporated in clinical trials. The Prostate Cancer Working Group included physicians, researchers, and a patient advocate. The group's process included 1) a systematic literature review to determine the prevalence and severity of symptoms, 2) a multistakeholder meeting sponsored by the NCI to review the evidence and build consensus, and 3) a postmeeting expert panel synthesis of findings to finalize recommendations. Five domains were recommended for localized prostate cancer: urinary incontinence, urinary obstruction and irritation, bowel-related symptoms, sexual dysfunction, and hormonal symptoms. Four domains were recommended for advanced prostate cancer: pain, fatigue, mental well-being, and physical well-being. Additional domains for consideration include decisional regret, satisfaction with care, and anxiety related to prostate cancer. These recommendations have been endorsed by the NCI for implementation. PMID:25006192

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

    PubMed Central

    Woo, Jennifer Ai-Lian; Chen, Leonard N.; Wang, Hongkun; Cyr, Robyn A.; Bhattasali, Onita; Kim, Joy S.; Moures, Rudy; Yung, Thomas M.; Lei, Siyuan; Collins, Brian Timothy; Suy, Simeng; Dritschilo, Anatoly; Lynch, John H.; Collins, Sean P.

    2015-01-01

    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 evaluating radiation modalities for early stage prostate cancer is lacking. To aid in clinical trial design, this study presents PROs over a 36-month period following SBRT for clinically localized prostate cancer. Methods: Between February 2008 and September 2010, 174 hormone-naïve patients with clinically localized prostate cancer were treated with 35–36.25 Gy SBRT (CyberKnife, Accuray) delivered in 5 fractions. Patients completed the validated Expanded Prostate Cancer Index Composite (EPIC)-26 questionnaire at baseline and all follow-ups. The proportion of patients developing a clinically significant decline in each EPIC domain score was determined. The minimally important difference (MID) was defined as a change of one-half the standard deviation from the baseline. Per Radiation Therapy Oncology Group (RTOG) 0938, we also examined the patients who experienced a decline in EPIC urinary domain summary score of >2 points (unacceptable toxicity defined as ≥60% of all patients reporting this degree of decline) and EPIC bowel domain summary score of >5 points (unacceptable toxicity defined as >55% of all patients reporting this degree of decline) from baseline to 1 year. Results: A total of 174 patients at a median age of 69 years received SBRT with a minimum follow-up of 36 months. The proportion of patients reporting a clinically significant decline (MID for urinary/bowel are 5.5/4.4) in EPIC urinary/bowel domain scores was 34%/30% at 6 months, 40%/32.2% at 12 months, and 32.8%/21.5% at 36 months. The patients reporting a decrease in the EPIC urinary domain summary score of >2 points was 43.2% (CI: 33.7%, 54.6%) at 6 months, 51.6% (CI: 43.4%, 59.7%) at 12 months, and 41.8% (CI: 33.3%, 50.6%) at 36 months. The

  17. How to measure outcomes of peripheral nerve surgery.

    PubMed

    Wang, Yirong; Sunitha, Malay; Chung, Kevin C

    2013-08-01

    Evaluation of outcomes after peripheral nerve surgeries include several assessment methods that reflect different aspects of recovery, including reinnervation, tactile gnosis, integrated sensory and motor function, pain and discomfort, and neurophysiologic and patient-reported outcomes. This review lists measurements addressing these aspects as well as the advantages and disadvantages of each tool. Because of complexities of neurophysiology, assessment remains a difficult process, which requires researchers to focus on measurements best relevant to specific conditions and research questions. PMID:23895715

  18. How to measure outcomes of peripheral nerve surgery.

    PubMed

    Wang, Yirong; Sunitha, Malay; Chung, Kevin C

    2013-08-01

    Evaluation of outcomes after peripheral nerve surgeries include several assessment methods that reflect different aspects of recovery, including reinnervation, tactile gnosis, integrated sensory and motor function, pain and discomfort, and neurophysiologic and patient-reported outcomes. This review lists measurements addressing these aspects as well as the advantages and disadvantages of each tool. Because of complexities of neurophysiology, assessment remains a difficult process, which requires researchers to focus on measurements best relevant to specific conditions and research questions.

  19. Integrating cancer survivors' experiences into UK cancer registries: design and development of the ePOCS system (electronic Patient-reported Outcomes from Cancer Survivors)

    PubMed Central

    Ashley, L; Jones, H; Thomas, J; Forman, D; Newsham, A; Morris, E; Johnson, O; Velikova, G; Wright, P

    2011-01-01

    Background: Understanding the psychosocial challenges of cancer survivorship, and identifying which patients experience ongoing difficulties, is a key priority. The ePOCS (electronic patient-reported outcomes from cancer survivors) project aims to develop and evaluate a cost-efficient, UK-scalable electronic system for collecting patient-reported outcome measures (PROMs), at regular post-diagnostic timepoints, and linking these with clinical data in cancer registries. Methods: A multidisciplinary team developed the system using agile methods. Design entailed process mapping the system's constituent parts, data flows and involved human activities, and undertaking usability testing. Informatics specialists built new technical components, including a web-based questionnaire tool and tracking database, and established component-connecting data flows. Development challenges were overcome, including patient usability and data linkage and security. Results: We have developed a system in which PROMs are completed online, using a secure questionnaire administration tool, accessed via a public-facing website, and the responses are linked and stored with clinical registry data. Patient monitoring and communications are semiautomated via a tracker database, and patient correspondence is primarily Email-based. The system is currently honed for clinician-led hospital-based patient recruitment. Conclusions: A feasibility test study is underway. Although there are possible challenges to sustaining and scaling up ePOCS, the system has potential to support UK epidemiological PROMs collection and clinical data linkage. PMID:22048035

  20. Provider perceptions of the value of same-day, electronic patient-reported measures for use in clinical HIV care.

    PubMed

    Fredericksen, R J; Tufano, J; Ralston, J; McReynolds, J; Stewart, M; Lober, W B; Mayer, K H; Mathews, W C; Mugavero, M J; Crane, P K; Crane, H M

    2016-11-01

    Strong evidence suggests that patient-reported outcomes (PROs) aid in managing chronic conditions, reduce omissions in care, and improve patient-provider communication. However, provider acceptability of PROs and their use in clinical HIV care is not well known. We interviewed providers (n = 27) from four geographically diverse HIV and community care clinics in the US that have integrated PROs into routine HIV care, querying perceived value, challenges, and use of PRO data. Perceived benefits included the ability of PROs to identify less-observable behaviors and conditions, particularly suicidal ideation, depression, and substance use; usefulness in agenda setting prior to a visit; and reduction of social desirability bias in patient-provider communication. Challenges included initial flow integration issues and ease of interpretation of PRO feedback. Providers value same-day, electronic patient-reported measures for use in clinical HIV care with the condition that PROs are (1) tailored to be the most clinically relevant to their population; (2) well integrated into clinic flow; and (3) easy to interpret, highlighting chief patient concerns and changes over time. PMID:27237187

  1. Provider perceptions of the value of same-day, electronic patient-reported measures for use in clinical HIV care.

    PubMed

    Fredericksen, R J; Tufano, J; Ralston, J; McReynolds, J; Stewart, M; Lober, W B; Mayer, K H; Mathews, W C; Mugavero, M J; Crane, P K; Crane, H M

    2016-11-01

    Strong evidence suggests that patient-reported outcomes (PROs) aid in managing chronic conditions, reduce omissions in care, and improve patient-provider communication. However, provider acceptability of PROs and their use in clinical HIV care is not well known. We interviewed providers (n = 27) from four geographically diverse HIV and community care clinics in the US that have integrated PROs into routine HIV care, querying perceived value, challenges, and use of PRO data. Perceived benefits included the ability of PROs to identify less-observable behaviors and conditions, particularly suicidal ideation, depression, and substance use; usefulness in agenda setting prior to a visit; and reduction of social desirability bias in patient-provider communication. Challenges included initial flow integration issues and ease of interpretation of PRO feedback. Providers value same-day, electronic patient-reported measures for use in clinical HIV care with the condition that PROs are (1) tailored to be the most clinically relevant to their population; (2) well integrated into clinic flow; and (3) easy to interpret, highlighting chief patient concerns and changes over time.

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

    PubMed

    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 < 0.01), satisfaction with lower face and 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. Patient-Reported Outcomes Following Living Kidney Donation: A Single Center Experience

    PubMed Central

    Rodrigue, James R.; Vishnevsky, Tanya; Fleishman, Aaron; Brann, Tracy; Evenson, Amy R.; Pavlakis, Martha; Mandelbrot, Didier A.

    2015-01-01

    This article describes the development and implementation of an initiative at one transplant center to annually assess psychosocial outcomes of living kidney donors. The current analysis focuses on a cohort of adults (n=208) who donated a kidney at BIDMC between September 2005 and August 2012, in which two post-donation annual assessments could be examined. One and two year post-donation surveys were returned by 59% (n=123) and 47% (n=98) of LKDs, respectively. Those who did not complete any survey were more likely to be younger (p=0.001), minority race/ethnicity (p<0.001), and uninsured at the time of donation (p=0.01) compared to those who returned at least one of the two annual surveys. The majority of donors reported no adverse physical or psychosocial consequences of donation, high satisfaction with the donation experience, and no donation decision regret. However, a sizable minority of donors felt more pain intensity than expected and recovery time was much slower than expected, and experienced a clinically significant decline in vitality. We describe how these outcomes are used to inform clinical practice at our transplant center as well as highlight challenges in donor surveillance over time. PMID:26123551

  4. Poor patient-reported outcome after hip replacement, related to poor perception of perioperative information, commoner in immigrants than in non-immigrants.

    PubMed

    Krupic, Ferid; Rolfson, Ola; Nemes, Szilard; Kärrholm, Johan

    2016-06-01

    Background and purpose - In preparing patients for total hip replacement surgery, providing thorough information helps to reduce anxiety, manage postoperative pain, prevent complications, and better engage patients in their rehabilitation. However, patient characteristics may have an influence on the ability to comprehend and assimilate the information given. We investigated differences in patients born in Sweden and those born outside Sweden regarding how they perceived the information given before THR, and if this was associated with different patient-reported outcomes one year after surgery. Patients and methods - From Sahlgrenska University Hospital, we recruited 150 patients born in Sweden and 50 patients born outside Sweden who were to undergo THR. We retrieved routinely collected data from the Swedish Hip Arthroplasty Register including basic demographic variables and patient-reported outcome measures, both preoperatively and at 1-year follow-up. In a separate survey carried out 1-2 weeks after surgery, patients were asked about the information provided in connection with the operation. Results - Patients born outside Sweden more frequently reported that they were poorly informed about possibilities to treat pain and about the operation itself. 1 year after the operation, patients born outside Sweden who, 1-2 weeks after the operation, had reported that they were poorly informed also reported having worse outcomes. Poorer results were found for the questions self-care and anxiety/depression in the EQ-5D questionnaire, pain on a visual analog scale (VAS), EQVAS, and EQ-5D index compared to those patients born in Sweden who had received at least some information of acceptable quality. Interpretation - One quarter of the patients were not satisfied with the information provided before and after THR. These patients more commonly reported perioperative anxiety and they were more often born outside Sweden. Poorly informed patients who had come from countries

  5. Poor patient-reported outcome after hip replacement, related to poor perception of perioperative information, commoner in immigrants than in non-immigrants

    PubMed Central

    Krupic, Ferid; Rolfson, Ola; Nemes, Szilard; Kärrholm, Johan

    2016-01-01

    Background and purpose In preparing patients for total hip replacement surgery, providing thorough information helps to reduce anxiety, manage postoperative pain, prevent complications, and better engage patients in their rehabilitation. However, patient characteristics may have an influence on the ability to comprehend and assimilate the information given. We investigated differences in patients born in Sweden and those born outside Sweden regarding how they perceived the information given before THR, and if this was associated with different patient-reported outcomes one year after surgery. Patients and methods From Sahlgrenska University Hospital, we recruited 150 patients born in Sweden and 50 patients born outside Sweden who were to undergo THR. We retrieved routinely collected data from the Swedish Hip Arthroplasty Register including basic demographic variables and patient-reported outcome measures, both preoperatively and at 1-year follow-up. In a separate survey carried out 1–2 weeks after surgery, patients were asked about the information provided in connection with the operation. Results Patients born outside Sweden more frequently reported that they were poorly informed about possibilities to treat pain and about the operation itself. 1 year after the operation, patients born outside Sweden who, 1–2 weeks after the operation, had reported that they were poorly informed also reported having worse outcomes. Poorer results were found for the questions self-care and anxiety/depression in the EQ-5D questionnaire, pain on a visual analog scale (VAS), EQVAS, and EQ-5D index compared to those patients born in Sweden who had received at least some information of acceptable quality. Interpretation One quarter of the patients were not satisfied with the information provided before and after THR. These patients more commonly reported perioperative anxiety and they were more often born outside Sweden. Poorly informed patients who had come from countries outside

  6. Having a Family Doctor is Associated with Some Better Patient-Reported Outcomes of Primary Care Consultations

    PubMed Central

    Lam, Cindy L. K.; Yu, Esther Y. T.; Lo, Yvonne Y. C.; Wong, Carlos K. H.; Mercer, Stewart M.; Fong, Daniel Y. T.; Lee, Albert; Lam, Tai Pong; Leung, Gabriel M.

    2014-01-01

    Background: Hong Kong (HK) has pluralistic primary care that is provided by a variety of doctors. The aim of our study was to assess patient-reported outcomes of primary care consultations in HK and whether having a family doctor (FD) made any difference. Methods: We interviewed by telephone 3148 subjects from 5174 contacted households (response rate 60.8%) randomly selected from the general population of HK about the experience of their last primary care consultations in September 2007 and April 2008. We compared the patient-reported outcomes (PRO) and patient-centered process of care in those with a FD, those with other types of regular primary care doctors (ORD) and those without any regular primary care doctor (NRD). PRO included patient enablement, global improvement in health, overall satisfaction, and likelihood of recommending their doctors to family and friends. Patient-centered process of care indicators was explanations about the illness, and address of patient’s concerns. Results: One thousand one hundred fifty, 746, and 1157 reported to have FD, ORD, and NRD, respectively. Over 80% of those with FD consulted their usual primary care doctors in the last consultation compared with 27% of those with NRD. Compared with subjects having ORD or NRD, subjects with FD reported being more enabled after the consultation and were more likely to recommend their doctors to family and friends. Subjects with FD and ORD were more likely than those having NRD to report a global improvement in health and satisfaction. FD group was more likely than the other two groups to report receiving an explanation on the diagnosis, nature, and expected course of the illness, and having their concerns addressed. Patient enablement was associated with explanation of diagnosis, nature, and expected course of illness, and address of patient’s concerns. Conclusion: People with a regular FD were more likely to feel being enabled and to experience patient-centered care in consultations

  7. Role of patient-reported outcomes and other efficacy endpoints in the drug approval process in Europe (2008-2012).

    PubMed

    Bansal, Dipika; Bhagat, Anil; Schifano, Fabrizio; Gudala, Kapil

    2015-12-01

    The present study aimed at systematically reviewing the role and extent of patient-reported outcomes (PROs) usage within the package of scientific evidence considered for marketing authorization (MA). All regulatory information published by the European Medicines Agency (EMA) for products authorized between January 2008 and December 2012 and appearing in the European Public Assessment Report (EPAR) database was examined for efficacy endpoints. The endpoints here considered included: PROs, clinician reported outcomes (CROs), and laboratory reported outcomes (LROs). LROs were the most frequently reported endpoints. Out of the 180 products here selected, 99 (55%), 67 (37%), and 30 (17%), respectively, used LROs, CROs and PROs as primary endpoints (PEs). PROs as any endpoints were used in 82 (46%) products. Out of these, PROs were documented as PE in 30 (37%), with 27 (33%) products having used PROs both as primary and non-PEs. PRO usage was most frequently identified with nervous system and antineoplastic agents. During the study period, the use of all the three types of endpoints appeared to be static. Both the regulatory bodies and the industry should ensure complete and clear reporting of all endpoints used, including PROs, to improve transparency. PMID:26031612

  8. Statistical approaches to analyse patient-reported outcomes as response variables: an application to health-related quality of life.

    PubMed

    Arostegui, Inmaculada; Núñez-Antón, Vicente; Quintana, José M

    2012-04-01

    Patient-reported outcomes (PRO) are used as primary endpoints in medical research and their statistical analysis is an important methodological issue. Theoretical assumptions of the selected methodology and interpretation of its results are issues to take into account when selecting an appropriate statistical technique to analyse data. We present eight methods of analysis of a popular PRO tool under different assumptions that lead to different interpretations of the results. All methods were applied to responses obtained from two of the health dimensions of the SF-36 Health Survey. The proposed methods are: multiple linear regression (MLR), with least square and bootstrap estimations, tobit regression, ordinal logistic and probit regressions, beta-binomial regression (BBR), binomial-logit-normal regression (BLNR) and coarsening. Selection of an appropriate model depends not only on its distributional assumptions but also on the continuous or ordinal features of the response and the fact that they are constrained to a bounded interval. The BBR approach renders satisfactory results in a broad number of situations. MLR is not recommended, especially with skewed outcomes. Ordinal methods are only appropriate for outcomes with a few number of categories. Tobit regression is an acceptable option under normality assumptions and in the presence of moderate ceiling or floor effect. The BLNR and coarsening proposals are also acceptable, but only under certain distributional assumptions that are difficult to test a priori. Interpretation of the results is more convenient when using the BBR, BLNR and ordinal logistic regression approaches.

  9. Validating a Patient-Reported Comorbidity Measure with Respect to Quality of Life in End-Stage Renal Disease

    PubMed Central

    Robinski, Maxi; Strich, Franz; Mau, Wilfried; Girndt, Matthias

    2016-01-01

    Purpose Medical record-derived comorbidity measures such as the Charlson Comorbidity Index (CCI) do not predict functional limitations or quality of life (QoL) in the chronically ill. Although these shortcomings are known since the 1980s, they have been largely ignored by the international literature. Recently, QoL has received growing interest as an end-point of interventional trials in Nephrology. The aim of this study is to compare a patient-reported comorbidity measure and the CCI with respect to its validity regarding QoL. Methods The German Self-Administered Comorbidity Questionnaire (SCQ-G) was completed by 780 adult end-stage renal disease-patients recruited from 55 dialysis units throughout Germany. Acceptance was evaluated via response rates. Content validity was examined by comparing the typical comorbidity pattern in dialysis patients and the pattern retrieved from our data. Convergent validity was assessed via kappa statistics. Data was compared to the CCI. Linear associations with QoL were examined (criterion validity). Results The SCQ-G was very well accepted by dialysis patients of all ages (response rate: 99%). Content validity can be interpreted as high (corresponding comorbidity items: 73.7%). Convergent validity was rather weak (.27≤ρ≤.29) but increased when comparing only concordant items (.39≤ρ≤.43). With respect to criterion validity, the SCQ-G performed better than the CCI regarding the correlation with QoL (e.g., SF-12-physical: SCQ-G total score: ρ = -.49 vs. CCI: ρ = -.36). Conclusions The patient-reported measure proved to be more valid than the external assessment when aiming at insights on QoL. Due to the inclusion of subjective limitations, the SCQ-G is more substantial with respect to patient-centered outcomes and might be used as additional measure in clinical trials. PMID:27294867

  10. Similar patient-reported outcomes and performance after total knee arthroplasty with or without patellar resurfacing

    PubMed Central

    Ali, Abdulemir; Lindstrand, Anders; Nilsdotter, Anna; Sundberg, Martin

    2016-01-01

    Background and purpose Knee pain after total knee arthroplasty (TKA) is not uncommon. Patellar retention in TKA is one cause of postoperative knee pain, and may lead to secondary addition of a patellar component. Patellar resurfacing in TKA is controversial. Its use ranges from 2% to 90% worldwide. In this randomized study, we compared the outcome after patellar resurfacing and after no resurfacing. Patients and methods We performed a prospective, randomized study of 74 patients with primary osteoarthritis who underwent a Triathlon CR TKA. The patients were randomized to either patellar resurfacing or no resurfacing. They filled out the VAS pain score and KOOS questionnaires preoperatively, and VAS pain, KOOS, and patient satisfaction 3, 12, and 72 months postoperatively. Physical performance tests were performed preoperatively and 3 months postoperatively. Results We found similar scores for VAS pain, patient satisfaction, and KOOS 5 subscales at 3, 12, and 72 months postoperatively in the 2 groups. Physical performance tests 3 months postoperatively were also similar in the 2 groups. No secondary resurfacing was performed in the group with no resurfacing during the first 72 months Interpretation Patellar resurfacing in primary Triathlon CR TKA is of no advantage regarding pain, physical performance, KOOS 5 subscales, or patient satisfaction compared to no resurfacing. None of the patients were reoperated with secondary addition of a patellar component within 6 years. According to these results, routine patellar resurfacing in primary Triathlon TKA appears to be unnecessary. PMID:27212102

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

    PubMed Central

    Orri, Massimiliano; Sibeoni, Jordan; Labey, Mathilde; Bousquet, Guilhem; Verneuil, Laurence; Revah-Levy, Anne

    2015-01-01

    Introduction 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. Methods and analysis 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. Ethics and dissemination 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

  12. Integrating Patient-Reported Outcomes into Spine Surgical Care through Visual Dashboards: Lessons Learned from Human-Centered Design

    PubMed Central

    Hartzler, Andrea L.; Chaudhuri, Shomir; Fey, Brett C.; Flum, David R.; Lavallee, Danielle

    2015-01-01

    Introduction: The collection of patient-reported outcomes (PROs) draws attention to issues of importance to patients—physical function and quality of life. The integration of PRO data into clinical decisions and discussions with patients requires thoughtful design of user-friendly interfaces that consider user experience and present data in personalized ways to enhance patient care. Whereas most prior work on PROs focuses on capturing data from patients, little research details how to design effective user interfaces that facilitate use of this data in clinical practice. We share lessons learned from engaging health care professionals to inform design of visual dashboards, an emerging type of health information technology (HIT). Methods: We employed human-centered design (HCD) methods to create visual displays of PROs to support patient care and quality improvement. HCD aims to optimize the design of interactive systems through iterative input from representative users who are likely to use the system in the future. Through three major steps, we engaged health care professionals in targeted, iterative design activities to inform the development of a PRO Dashboard that visually displays patient-reported pain and disability outcomes following spine surgery. Findings: Design activities to engage health care administrators, providers, and staff guided our work from design concept to specifications for dashboard implementation. Stakeholder feedback from these health care professionals shaped user interface design features, including predefined overviews that illustrate at-a-glance trends and quarterly snapshots, granular data filters that enable users to dive into detailed PRO analytics, and user-defined views to share and reuse. Feedback also revealed important considerations for quality indicators and privacy-preserving sharing and use of PROs. Conclusion: Our work illustrates a range of engagement methods guided by human-centered principles and design

  13. Complementary and Alternative Medicine use, Patient Reported Outcomes, and Treatment Satisfaction among Men with Localized Prostate Cancer

    PubMed Central

    Ramsey, Scott D.; Zeliadt, Steven B.; Blough, David K.; Fedorenko, Catherine R.; Fairweather, Megan E.; McDermott, Cara L.; Penson, David F.; Van Den Eeden, Stephen K.; Hamilton, Ann S.; Arora, Neeraj K.

    2012-01-01

    Objectives We sought to evaluate the association between complementary and alternative medicine (CAM) use, satisfaction with treatment, and patient-reported outcomes following treatment. Methods The Prostate CAncer Therapy Selection Study (PCATS) prospectively surveyed patients newly diagnosed with localized prostate cancer about their treatment decision making process and outcomes. The PCATS study recruited patients in three geographic areas through hospital-based urology clinics and community urology practices. Results More than 700 patients completed the baseline and follow-up surveys. More than 50% of respondents reported using CAM, 39% if prayer was excluded as a type of CAM. In multivariate analysis, factors related to communication with the treating physician, but not CAM use, were associated with treatment satisfaction. The likelihood of stability or improvement in urinary, bowel, and sexual function at 6 months was related to the choice of primary therapy, but unrelated to CAM use. Conclusions In this prospective observational study, CAM use was highly prevalent but unrelated to treatment satisfaction or changes in functional status. The impact of CAM on these endpoints remains to be established in comparative effectiveness studies. PMID:22546381

  14. A Prospective Study of the Feasibility and Acceptability of a Web-Based, Electronic Patient-Reported Outcomes System in Assessing Patient Recovery after Major Gynecologic Cancer Surgery

    PubMed Central

    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

    2013-01-01

    Purpose 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. Methods 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” (Symptoms 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. Results 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%). Conclusion 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. PMID:22871467

  15. Patient-reported depression measures in cancer: a meta-review.

    PubMed

    Wakefield, Claire E; Butow, Phyllis N; Aaronson, Neil A; Hack, Thomas F; Hulbert-Williams, Nicholas J; Jacobsen, Paul B

    2015-07-01

    The patient-reported depression measures that perform best in oncology settings have not yet been identified. We did a meta-review to integrate the findings of reviews of more than 50 depression measures used in adults with, or recovering from, any type of cancer. We searched Medline, PsycINFO, Embase, and grey literature from 1999 to 2014 to identify 19 reviews representing 372 primary studies. 11 reviews were rated as being of high quality (defined as meeting at least 20 criteria in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement). The Hospital Anxiety Depression Scale (HADS) was the most thoroughly evaluated measure, but was limited by cutpoint variability. The HADS had moderate screening utility indices and was least recommended in advanced cancer or palliative care. The Beck Depression Inventory was more generalisable across cancer types and disease stages, with good indices for screening and case finding. The Center for Epidemiologic Studies Depression Scale was the best-weighted measure in terms of responsiveness. This meta-review provides a comprehensive overview of the strengths and limitations of available depression measures. It can inform the choice of the best measure for specific settings and purposes.

  16. Patient-reported depression measures in cancer: a meta-review.

    PubMed

    Wakefield, Claire E; Butow, Phyllis N; Aaronson, Neil A; Hack, Thomas F; Hulbert-Williams, Nicholas J; Jacobsen, Paul B

    2015-07-01

    The patient-reported depression measures that perform best in oncology settings have not yet been identified. We did a meta-review to integrate the findings of reviews of more than 50 depression measures used in adults with, or recovering from, any type of cancer. We searched Medline, PsycINFO, Embase, and grey literature from 1999 to 2014 to identify 19 reviews representing 372 primary studies. 11 reviews were rated as being of high quality (defined as meeting at least 20 criteria in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement). The Hospital Anxiety Depression Scale (HADS) was the most thoroughly evaluated measure, but was limited by cutpoint variability. The HADS had moderate screening utility indices and was least recommended in advanced cancer or palliative care. The Beck Depression Inventory was more generalisable across cancer types and disease stages, with good indices for screening and case finding. The Center for Epidemiologic Studies Depression Scale was the best-weighted measure in terms of responsiveness. This meta-review provides a comprehensive overview of the strengths and limitations of available depression measures. It can inform the choice of the best measure for specific settings and purposes. PMID:26303561

  17. Obesity effect on a multimodal physiotherapy program for low back pain suffers: patient reported outcome

    PubMed Central

    2013-01-01

    Background Several studies have linked obesity to the increased likelihood of lower back pain, but there are no studies focussing on the effectiveness of a multimodal physiotherapy programme (MPP) in obese subjects who suffer from chronic non-specific lower back pain (CNLBP). The aim of this study was to compare the effectiveness of an MPP in obese (G1) (body mass index (BMI):≥30) and non-obese (G2) (BMI:<30) patients with CNLBP. Methods A quasi-experimental study with pre- and post-intervention evaluations of an MPP (lasting 8 weeks) was conducted on obese and non-obese patients with CNLBP. A total of 53 people were included in the study: G1, composed of 19 patients (10 men and 9 women) with a BMI of 33.75 and a mean age of 52.94 years, and G2, composed of 34 patients (18 men and 16 women) with a mean age of 49.19 years and an average BMI of 25.56. All patients were measured to calculate pre-intervention (baseline) and post-intervention (8 weeks) changes in disability (RMQ) and health related quality of life in physical and mental health component state of SF12 and quality of life (EQ-5D and EQ-VAS). Results Post-intervention, non-obese group shown significant high improve than obese group in disability (RMQ: 4.00), physical component state of SF-12: (-7.26) and quality of life (EQ-VAS.: -10.49). Conclusions In patients with CNLBP, a BMI more than or equal to 30 minimises the effects of an MPP lasting 8 weeks. PMID:23663679

  18. Recommendations for Evaluating and Selecting Appropriately Valued Outcome Measures.

    PubMed

    Hawkins, Richard J

    2016-01-01

    The changing healthcare environment has essentially mandated that outcome scores play an increasing role in orthopaedic research and clinical care. Value is defined as the best outcome at the lowest cost. The reasoning behind the collection of outcome scores can be examined from several perspectives. The process of selecting an appropriate outcome measure involves analyzing its psychometrics in addition to other aspects, such as responsiveness, reliability, validity, and the ability to detect change in a reasonable manner. A minimal clinically important difference measures clinical change, and a minimal detectable change measures statistical change. Orthopaedic surgeons are most interested in minimal clinically important differences because they indicate meaningful clinical changes. Guidelines for selecting appropriately valued outcome measures include the consideration of patient-reported outcomes, proper psychometrics, validated scores, and cost effectiveness.

  19. Recommendations for Evaluating and Selecting Appropriately Valued Outcome Measures.

    PubMed

    Hawkins, Richard J

    2016-01-01

    The changing healthcare environment has essentially mandated that outcome scores play an increasing role in orthopaedic research and clinical care. Value is defined as the best outcome at the lowest cost. The reasoning behind the collection of outcome scores can be examined from several perspectives. The process of selecting an appropriate outcome measure involves analyzing its psychometrics in addition to other aspects, such as responsiveness, reliability, validity, and the ability to detect change in a reasonable manner. A minimal clinically important difference measures clinical change, and a minimal detectable change measures statistical change. Orthopaedic surgeons are most interested in minimal clinically important differences because they indicate meaningful clinical changes. Guidelines for selecting appropriately valued outcome measures include the consideration of patient-reported outcomes, proper psychometrics, validated scores, and cost effectiveness. PMID:27049224

  20. Tofacitinib versus methotrexate in rheumatoid arthritis: patient-reported outcomes from the randomised phase III ORAL Start trial

    PubMed Central

    Strand, Vibeke; Lee, Eun Bong; Fleischmann, Roy; Koncz, Tamas; Zwillich, Samuel H; Gruben, David; Wilkinson, Bethanie; Krishnaswami, Sriram; Wallenstein, Gene

    2016-01-01

    Objectives To compare patient-reported outcomes (PROs) in methotrexate (MTX)-naive patients (defined as no prior treatment or ≤3 doses) receiving tofacitinib versus MTX. Methods In the 24-month, phase III, randomised, controlled, ORAL Start trial (NCT01039688), patients were randomised 2:2:1 to receive tofacitinib 5 mg two times per day (n=373), tofacitinib 10 mg two times per day (n=397) or MTX (n=186). PROs assessed included Patient Global Assessment of disease (PtGA), pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and health-related quality of life (Short Form-36 [SF-36]). Results PROs improved following tofacitinib and MTX treatment: benefits were sustained over 24 months. Patients receiving tofacitinib reported earlier responses which were significantly different between each tofacitinib dose and MTX at month 3 through month 24. At month 6 (primary end point), significant improvements versus MTX were observed in PtGA, pain, HAQ-DI, SF-36 Physical Component Summary (PCS), 5/8 domain scores and FACIT-F with tofacitinib 5 mg two times per day; all PROs, except SF-36 Mental Component Summary Score and Medical Outcomes Survey-Sleep, with tofacitinib 10 mg two times per day. At month 6, the proportion of patients reporting improvements ≥minimum clinically important difference were significant versus MTX with tofacitinib 5 mg two times per day in PtGA and 3/8 SF-36 domains; and with tofacitinib 10 mg two times per day in PtGA, pain, HAQ-DI, SF-36 PCS, 4/8 domains and FACIT-F. Conclusions Patients with rheumatoid arthritis receiving tofacitinib 5 and 10 mg two times per day monotherapy versus MTX reported statistically significant and clinically meaningful improvements in multiple PROs over 24 months; onset of benefit with tofacitinib treatment occurred earlier. Trial registration number NCT01039688. PMID:27752357

  1. Outcome measures of antidepressive therapy.

    PubMed

    Rosenberg, R

    2000-01-01

    A variety of outcome measures assessing antidepressive therapy are available. However, in randomized clinical trials, the Hamilton Rating Scale for Depression (HAM-D) is often the primary outcome measure. Results from factor analysis and Rasch item analysis indicate that the HAM-D is heterogeneous and that the sum of items scores may not be an adequate measure of the severity of depression. A Melancholia Scale of 11 items has been suggested as a more valid measure of the core symptoms of affective syndrome. Other global outcome measures, focusing on health-related quality of life issues and on social functioning as well as macro-economic analyses are also used in depression. Applying stringent and well-documented outcome measures in randomized clinical trials of antidepressants may give the clinician a better indication of the most appropriate drug for treatment of the individual patient.

  2. Can we use social media to support content validity of patient-reported outcome instruments in medical product development?

    PubMed

    Rothman, Margaret; Gnanaskathy, Ari; Wicks, Paul; Papadopoulos, Elektra J

    2015-01-01

    We report a panel designed to open a dialog between pharmaceutical sponsors, regulatory reviewers, and other stakeholders regarding the use of social media to collect data to support the content validity of patient-reported outcome instruments in the context of medical product labeling. Multiple stakeholder perspectives were brought together to better understand the issues encountered in pursuing social media as a form of data collection to support content validity. Presenters represented a pharmaceutical sponsor of clinical trials, a regulatory reviewer from the Food and Drug Administration, and an online data platform provider. Each presenter shared its perspective on the advantages and disadvantages of using social media to collect this type of information. There was consensus that there is great potential for using social media for this purpose. There remain, however, unanswered questions that need to be addressed such as identifying which type of social media is most appropriate for data collection and ensuring that participants are representative of the target population while maintaining the advantages of anonymity provided by online platforms. The use of social media to collect evidence of content validity holds much promise. Clarification of issues that need to be addressed and accumulation of empirical evidence to address these questions are essential to moving forward. PMID:25595228

  3. Can we use social media to support content validity of patient-reported outcome instruments in medical product development?

    PubMed

    Rothman, Margaret; Gnanaskathy, Ari; Wicks, Paul; Papadopoulos, Elektra J

    2015-01-01

    We report a panel designed to open a dialog between pharmaceutical sponsors, regulatory reviewers, and other stakeholders regarding the use of social media to collect data to support the content validity of patient-reported outcome instruments in the context of medical product labeling. Multiple stakeholder perspectives were brought together to better understand the issues encountered in pursuing social media as a form of data collection to support content validity. Presenters represented a pharmaceutical sponsor of clinical trials, a regulatory reviewer from the Food and Drug Administration, and an online data platform provider. Each presenter shared its perspective on the advantages and disadvantages of using social media to collect this type of information. There was consensus that there is great potential for using social media for this purpose. There remain, however, unanswered questions that need to be addressed such as identifying which type of social media is most appropriate for data collection and ensuring that participants are representative of the target population while maintaining the advantages of anonymity provided by online platforms. The use of social media to collect evidence of content validity holds much promise. Clarification of issues that need to be addressed and accumulation of empirical evidence to address these questions are essential to moving forward.

  4. Electronic Patient-Reported Outcomes: The Time Is Ripe for Integration Into Patient Care and Clinical Research.

    PubMed

    Schwartzberg, Lee

    2016-01-01

    In the emerging team-based approach to delivering cancer care, collecting patient-reported outcomes (PROs) provides longitudinal monitoring of treatment adverse effects, disease complications, functional statuses, and psychological states throughout the cancer continuum for all providers to use. Electronic systems offer added capabilities, including easy quantitation of individual symptom items and aggregated scales, standardization, and longitudinal tracking of patient surveys for trend analysis over time. An ideal electronic PRO (ePRO) platform is clinically relevant, validated, and reliable and would offer patient usability. Additionally, it should allow for automated responses to and from patients, have scheduling functionality, and send real-time alerts to site personnel and patients. Clinical interfaces should be easy to read and integrated into the electronic medical record. Multiple ePRO systems, often using electronic tablets, have been created and are beginning to be widely deployed. The Patient Care Monitor is one example of a system that has evolved into a comprehensive patient engagement platform, with a complete review of systems survey and capabilities for mobile health usage. Recent clinical trials have established ePRO systems as an effective method of providing information, which aids improved patient outcomes, including reduced health resource utilization and longer time on therapy. ePROs are also increasingly incorporated into clinical trials, where they can provide more thorough reporting of adverse events than can be captured by alternative methods. Mobile devices have the potential to become the method by which all members of the provider team communicate with patients both at the point-of-care and between clinic visits to optimize care delivery. PMID:27249775

  5. Functional Status Assessment of Patients With COPD: A Systematic Review of Performance-Based Measures and Patient-Reported Measures.

    PubMed

    Liu, Yang; Li, Honghe; Ding, Ning; Wang, Ningning; Wen, Deliang

    2016-05-01

    Presently, there is no recommendation on how to assess functional status of chronic obstructive pulmonary disease (COPD) patients. This study aimed to summarize and systematically evaluate these measures.Studies on measures of COPD patients' functional status published before the end of January 2015 were included using a search filters in PubMed and Web of Science, screening reference lists of all included studies, and cross-checking against some relevant reviews. After title, abstract, and main text screening, the remaining was appraised using the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) 4-point checklist. All measures from these studies were rated according to best-evidence synthesis and the best-rated measures were selected.A total of 6447 records were found and 102 studies were reviewed, suggesting 44 performance-based measures and 14 patient-reported measures. The majority of the studies focused on internal consistency, reliability, and hypothesis testing, but only 21% of them employed good or excellent methodology. Their common weaknesses include lack of checks for unidimensionality, inadequate sample sizes, no prior hypotheses, and improper methods. On average, patient-reported measures perform better than performance-based measures. The best-rated patient-reported measures are functional performance inventory (FPI), functional performance inventory short form (FPI-SF), living with COPD questionnaire (LCOPD), COPD activity rating scale (CARS), University of Cincinnati dyspnea questionnaire (UCDQ), shortness of breath with daily activities (SOBDA), and short-form pulmonary functional status scale (PFSS-11), and the best-rated performance-based measures are exercise testing: 6-minute walk test (6MWT), endurance treadmill test, and usual 4-meter gait speed (usual 4MGS).Further research is needed to evaluate the reliability and validity of performance-based measures since present studies failed to provide convincing

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

    ERIC Educational Resources Information Center

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

    2015-01-01

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

  7. Multi-domain patient reported outcomes of irritable bowel syndrome: exploring person centered perspectives to better understand symptom severity scores

    PubMed Central

    Lackner, Jeffrey M.; Jaccard, James; Baum, Charles

    2012-01-01

    Objectives Patient reported outcomes (PRO) assessing multiple gastrointestinal symptoms are central to characterizing the therapeutic benefit of novel agents for irritable bowel syndrome (IBS). Common approaches that sum or average responses across different illness components must be unidimensional and have small unique variances to avoid aggregation bias and misinterpretation of clinical data. This study sought to evaluate the unidimensionality of the IBS Symptom Severity Scale (IBS-SSS) and to explore person centered cluster analytic methods for characterizing multivariate-based patient profiles. Methods Ninety-eight Rome-diagnosed IBS patients completed the IBS-SSS and a single, global item of symptom severity (UCLA Symptom Severity Scale) at pretreatment baseline of an NIH funded clinical trial. A k-means cluster analyses were performed on participants symptom severity scores. Results The IBS-SSS was not unidimensional. Exploratory cluster analyses revealed four common symptom profiles across five items of the IBS-SSS. One cluster of patients (25%) had elevated scores on pain frequency and bowel dissatisfaction, with less elevated but still high scores on life interference and low pain severity ratings. A second cluster (19%) was characterized by intermediate scores on both pain dimensions, but more elevated scores on bowel dissatisfaction. A third cluster (18%) was elevated across all IBS-SSS sub-components. The fourth and most common cluster (37%) had relatively low scores on all dimensions except bowel dissatisfaction and life interference due to IBS symptoms. Conclusions PRO endpoints and research on IBS more generally relying on multicomponent assessments of symptom severity should take into account the multidimensional structure of symptoms to avoid aggregation bias and to optimize the sensitivity of detecting treatment effects. PMID:23337220

  8. Patient-reported satisfaction and cosmesis outcomes following laparoscopic adrenalectomy: Laparoendoscopic single-site adrenalectomy vs. conventional laparoscopic adrenalectomy

    PubMed Central

    Inoue, Shogo; Ikeda, Kenichiro; Kobayashi, Kanao; Kajiwara, Mitsuru; Teishima, Jun; Matsubara, Akio

    2014-01-01

    Introduction: We evaluate patient-reported satisfaction and cosmesis of laparoendoscopic single-site adrenalectomy (LESS-A) in comparison with that of conventional laparoscopic adrenalectomy (CLA). Methods: A total of 19 and 104 patients who respectively underwent LESS-A and CLA between May 1996 and June 2011 were included in the study. Questionnaires inquiring about scar pain (0: not painful, 10: very painful), satisfaction (0: not satisfied, 10: very satisfied) and cosmesis (0: very unsightly, 10: very beautiful) on the basis of a visual analogue scale were sent to patients postoperatively. Results: The respondents consisted of 11 and 54 patients who underwent LESS-A and CLA, respectively. There was no significant inter-group difference in age, sex, affected side or body mass index. No significant differences were observed in operative time or estimated blood loss. There were also no significant differences in pain (0.67 vs. 0.57, p = 0.393), satisfaction (8.92 vs. 8.46, p = 0.453), or cosmesis score (8.58 vs. 8.00, p = 0.487) between the LESS-A and CLA groups overall. In female patients, the satisfaction score was significantly higher in the LESS-A group than in the CLA group (10.0 vs. 8.72, p = 0.049). In young patients (<50 years old), the satisfaction score was also significantly higher in the LESS-A group than in the CLA group (9.17 vs. 6.38, p = 0.036). Conclusions: Young patients and female patients who had received LESS-A adrenal surgery were more satisfied with the scar outcomes than were the young patients and female patients who had received CLA. We suggest that this patient subset most values the cosmetic benefits of LESS-A. PMID:24454596

  9. Symptoms and Distress in Children With Advanced Cancer: Prospective Patient-Reported Outcomes From the PediQUEST Study

    PubMed Central

    Wolfe, Joanne; Orellana, Liliana; Ullrich, Christina; Cook, E. Francis; Kang, Tammy I.; Rosenberg, Abby; Geyer, Russ; Feudtner, Chris; Dussel, Veronica

    2015-01-01

    Purpose Thousands of children are living with advanced cancer; yet patient-reported outcomes (PROs) have rarely been used to describe their experiences. We aimed to describe symptom distress in 104 children age 2 years or older with advanced cancer enrolled onto the Pediatric Quality of Life and Evaluation of Symptoms Technology (PediQUEST) Study (multisite clinical trial evaluating an electronic PRO system). Methods Symptom data were collected using age- and respondent-adapted versions of the PediQUEST Memorial Symptom Assessment Scale (PQ-MSAS) at most once per week. Clinical and treatment data were obtained from medical records. Individual symptom scores were dichotomized into high/low distress. Determinants of PQ-MSAS scores were explored using linear mixed-effects models. Results During 9 months of follow-up, PQ-MSAS was administered 920 times: 459 times in teens (99% self-report), 249 times in children ages 7 to 12 years (96% child/parent report), and 212 times in those ages 2 to 6 years (parent reports). Common symptoms included pain (48%), fatigue (46%), drowsiness (39%), and irritability (37%); most scores indicated high distress. Among the 73 PQ-MSAS surveys administered in the last 12 weeks of life, pain was highly prevalent (62%; 58% with high distress). Being female, having a brain tumor, experiencing recent disease progression, and receiving moderate- or high-intensity cancer-directed therapy in the prior 10 days were associated with worse PQ-MSAS scores. In the final 12 weeks of life, receiving mild cancer-directed therapy was associated with improved psychological PQ-MSAS scores. Conclusion Children with advanced cancer experience high symptom distress. Strategies to promote intensive symptom management are indicated, especially with disease progression or administration of intensive treatments. PMID:25918277

  10. Standardized Outcome Measurement for Patients With Coronary Artery Disease: Consensus From the International Consortium for Health Outcomes Measurement (ICHOM)

    PubMed Central

    McNamara, Robert L; Spatz, Erica S; Kelley, Thomas A; Stowell, Caleb J; Beltrame, John; Heidenreich, Paul; Tresserras, Ricard; Jernberg, Tomas; Chua, Terrance; Morgan, Louise; Panigrahi, Bishnu; Rosas Ruiz, Alba; Rumsfeld, John S; Sadwin, Lawrence; Schoeberl, Mark; Shahian, David; Weston, Clive; Yeh, Robert; Lewin, Jack

    2015-01-01

    Background Coronary artery disease (CAD) outcomes consistently improve when they are routinely measured and provided back to physicians and hospitals. However, few centers around the world systematically track outcomes, and no global standards exist. Furthermore, patient-centered outcomes and longitudinal outcomes are under-represented in current assessments. Methods and Results The nonprofit International Consortium for Health Outcomes Measurement (ICHOM) convened an international Working Group to define a consensus standard set of outcome measures and risk factors for tracking, comparing, and improving the outcomes of CAD care. Members were drawn from 4 continents and 6 countries. Using a modified Delphi method, the ICHOM Working Group defined who should be tracked, what should be measured, and when such measurements should be performed. The ICHOM CAD consensus measures were designed to be relevant for all patients diagnosed with CAD, including those with acute myocardial infarction, angina, and asymptomatic CAD. Thirteen specific outcomes were chosen, including acute complications occurring within 30 days of acute myocardial infarction, coronary artery bypass grafting surgery, or percutaneous coronary intervention; and longitudinal outcomes for up to 5 years for patient-reported health status (Seattle Angina Questionnaire [SAQ-7], elements of Rose Dyspnea Score, and Patient Health Questionnaire [PHQ-2]), cardiovascular hospital admissions, cardiovascular procedures, renal failure, and mortality. Baseline demographic, cardiovascular disease, and comorbidity information is included to improve the interpretability of comparisons. Conclusions ICHOM recommends that this set of outcomes and other patient information be measured for all patients with CAD. PMID:25991011

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

    PubMed Central

    2012-01-01

    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 clinical practice and

  12. Hypoglycaemic events in patients with type 2 diabetes in the United Kingdom: associations with patient-reported outcomes and self-reported HbA1c

    PubMed Central

    2013-01-01

    Background One possible barrier to effective diabetes self-management is hypoglycaemia associated with diabetes medication. The current study was conducted to characterize hypoglycaemic events among UK patients with type 2 diabetes (T2D) treated with antihyperglycaemic medications, and assess the relationship between experience of hypoglycaemic events and health outcomes, including glycaemic control, health-related quality of life, impairment to work and non-work activities, treatment satisfaction, adherence to treatment, fear of hypoglycaemia, and healthcare resource use. Methods An online survey of 1,329 T2D patients in UK drawn from an opt-in survey panel was conducted in February of 2012 with monthly follow-up questionnaires for five months. Measures included self-reported HbA1c, EQ-5D, Work Productivity and Activity Impairment questionnaire, Diabetes Medication Satisfaction Tool, Morisky medication adherence scale, the Hypoglycaemia Fear Survey (revised), and self-reported healthcare resource use. Comparisons were conducted using t-tests and chi-square tests for continuous and categorical variables, respectively. Results Baseline comparisons showed that worse HbA1c, greater diabetes-related healthcare resource use, greater fear of hypoglycaemia, and impaired health outcomes were associated with experience of hypoglycaemia in the four weeks prior to baseline. Longitudinal results were similar in direction but differences on few measures were significant. Conclusions In real-world UK T2D patients, hypoglycaemia is associated with worse self-reported glycaemic control, behaviours that contribute to worse glycaemic control, and impairment in patient-reported outcomes. PMID:24351086

  13. Patient-Reported Outcomes in Cancer Drug Development and US Regulatory Review: Perspectives From Industry, the Food and Drug Administration, and the Patient.

    PubMed

    Basch, Ethan; Geoghegan, Cindy; Coons, Stephen Joel; Gnanasakthy, Ari; Slagle, Ashley F; Papadopoulos, Elektra J; Kluetz, Paul G

    2015-06-01

    Data reported directly by patients about how they feel and function are rarely included in oncology drug labeling in the United States, in contrast to Europe and to nononcology labeling in the United States, where this practice is more common. Multiple barriers exist, including challenges unique to oncology trials, and industry's concerns regarding cost, logistical complexities, and the Food and Drug Administration's (FDA's) rigorous application of its 2009 guidance on the use of patient-reported outcome (PRO) measures. A panel consisting of representatives of industry, FDA, the PRO Consortium, clinicians, and patients was assembled at a 2014 workshop cosponsored by FDA to identify practical recommendations for overcoming these barriers. Key recommendations included increasing proactive encouragement by FDA to clinical trial sponsors for including PROs in drug development programs; provision of comprehensive PRO plans by sponsors to FDA early in drug development; promotion of an oncology-specific PRO research agenda; development of an approach to existing ("legacy") PRO measures, when appropriate (focused initially on symptoms and functional status); and increased FDA and industry training in PRO methodology. FDA has begun implementing several of these recommendations. PMID:26181187

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

    PubMed Central

    Delgado-Herrera, Leticia; Lasch, Kathryn; Popielnicki, Ana; Nishida, Akito; Arbuckle, Rob; Banderas, Benjamin; Zentner, Susan; Gagainis, Ingrid; Zeiher, Bernhardt

    2016-01-01

    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 Linguistic and cultural adaptation concerns identified during the translatability assessment required minor revisions, mainly the presentation of dates/times and word structure. During the cognitive debriefing interviews, two of five Spanish respondents misunderstood the term “bowel movement” to mean only diarrhea in the Spanish version. Consequently, the term was changed from “movimiento intestinal” to “evacuaciones”. None of the Japanese respondents identified issues with the Japanese version. Conclusion

  15. Body image in idiopathic scoliosis: a comparison study of psychometric properties between four patient-reported outcome instruments

    PubMed Central

    2014-01-01

    Background Four patient-reported outcome (PRO) instruments are commonly used to assess body image in idiopathic scoliosis (IS): the Quality of Life Profile for Spinal Deformities (QLPSD), SRS-22 Self-Image scale, Spinal Appearance Questionnaire (SAQ), and Trunk Appearance Perception Scale (TAPS). The aim of this study is to compare the psychometric properties of these instruments in patients with IS and report the translational/cultural adaptation of the SAQ to Spanish. Methods The four instruments in a Spanish version were administered to 80 patients with IS aged 10 to 40 years old. The sample was stratified according to scoliosis magnitude (less and more than 45º). Analysis was also conducted for age groups. The psychometric properties studied included convergent and divergent construct validity, as well as internal consistency. Convergent validity was evaluated by correlation analysis between the self-image instruments and Cobb angle. Divergent validity was assessed with correlation analysis between PRO scores and SRS-22 dimensions scores such as Function, Pain and Mental Health. Results In the overall sample, each of the PRO instruments demonstrated high internal consistency (QLPSD Body Image, α = 0.80; SRS-22 Self Image, α = 0.78; SAQ, α = 0.89; TAPS, α = 0.87), also both for younger and adult patients subgroups. Correlation with curve magnitude was significant for each of the four scales. However, the correlation was higher for the pictorial scales (SAQ Appearance r = 0.61, TAPS r = - 0.62) than for the textual scales (QLPSD-bi r = 0.36, SRS-22 Self-Image scale r = - 0.41). In the younger group, correlation between Cobb angle and textual scales (QLPSD-bi and SRS-22 Self-Image Scale) was not significant. Body Image scales showed significant correlations with SRS-22 Pain, Function and Mental Health dimensions. Conclusions All four instruments tested have good psychometric properties. Pictorial scales (SAQ Appearance and

  16. A Prospective Study Assessing Complication Rates and Patient-Reported Outcomes in Breast Reconstructions Using a Novel, Deep Dermal Human Acellular Dermal Matrix

    PubMed Central

    Vu, Michael M.; De Oliveira, Gildasio S.; Mayer, Kristen E.; Blough, Jordan T.

    2015-01-01

    Abstract Background: The value proposition of an acellular dermal matrix (ADM) taken from the deep dermis is that the allograft may be more porous, allowing for enhanced integration and revascularization. In turn, this characteristic may attenuate complications related to foreign body reactions, seromas, and infection. However, this is juxtaposed against the potential loss of allograft structural integrity, with subsequent risk of malposition and extrusion. Despite the active use of novel, deep dermal ADMs, the clinical outcomes of this new technology has not been well studied. Methods: This is a prospective study to evaluate surgical and patient-reported outcomes using a deep dermal ADM, FlexHD Pliable. Surgical outcomes and BREAST-Q patient-reported outcomes were evaluated postoperatively at 2- and 6-month time points. Results: Seventy-two breasts (41 patients) underwent reconstruction. Complication rate was 12.5%, including 2 hematomas and 7 flap necroses. One case of flap necrosis led to reconstructive failure. Notably, there were no cases of infection, seroma, or implant extrusion or malposition. Average BREAST-Q scores were satisfaction with outcome (70.13 ± 23.87), satisfaction with breasts (58.53 ± 20.00), psychosocial well being (67.97 ± 20.93), sexual well being (54.11 ± 27.72), and physical well being (70.45 ± 15.44). Two-month postoperative BREAST-Q scores decreased compared with baseline and returned to baseline by 6 months. Postoperative radiation therapy had a negative effect on satisfaction with breasts (P = 0.004) and sexual well being (P = 0.006). Conclusions: Deep dermal ADM is a novel modification of traditional allograft technology. Use of the deep dermal ADM yielded acceptably low complication rates and satisfactory patient-reported outcomes. PMID:26894010

  17. 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)

    PubMed Central

    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

  18. Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).

    PubMed

    Basch, Ethan; Reeve, Bryce B; Mitchell, Sandra A; Clauser, Steven B; Minasian, Lori M; Dueck, Amylou C; Mendoza, Tito R; Hay, Jennifer; Atkinson, Thomas M; Abernethy, Amy P; Bruner, Deborah W; Cleeland, Charles S; Sloan, Jeff A; Chilukuri, Ram; Baumgartner, Paul; Denicoff, Andrea; St Germain, Diane; O'Mara, Ann M; Chen, Alice; Kelaghan, Joseph; Bennett, Antonia V; Sit, Laura; Rogak, Lauren; Barz, Allison; Paul, Diane B; Schrag, Deborah

    2014-09-01

    The standard approach for documenting symptomatic adverse events (AEs) in cancer clinical trials involves investigator reporting using the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE). Because this approach underdetects symptomatic AEs, the NCI issued two contracts to create a patient-reported outcome (PRO) measurement system as a companion to the CTCAE, called the PRO-CTCAE. This Commentary describes development of the PRO-CTCAE by a group of multidisciplinary investigators and patient representatives and provides an overview of qualitative and quantitative studies of its measurement properties. A systematic evaluation of all 790 AEs listed in the CTCAE identified 78 appropriate for patient self-reporting. For each of these, a PRO-CTCAE plain language term in English and one to three items characterizing the frequency, severity, and/or activity interference of the AE were created, rendering a library of 124 PRO-CTCAE items. These items were refined in a cognitive interviewing study among patients on active cancer treatment with diverse educational, racial, and geographic backgrounds. Favorable measurement properties of the items, including construct validity, reliability, responsiveness, and between-mode equivalence, were determined prospectively in a demographically diverse population of patients receiving treatments for many different tumor types. A software platform was built to administer PRO-CTCAE items to clinical trial participants via the internet or telephone interactive voice response and was refined through usability testing. Work is ongoing to translate the PRO-CTCAE into multiple languages and to determine the optimal approach for integrating the PRO-CTCAE into clinical trial workflow and AE analyses. It is envisioned that the PRO-CTCAE will enhance the precision and patient-centeredness of adverse event reporting in cancer clinical research. PMID:25265940

  19. Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).

    PubMed

    Basch, Ethan; Reeve, Bryce B; Mitchell, Sandra A; Clauser, Steven B; Minasian, Lori M; Dueck, Amylou C; Mendoza, Tito R; Hay, Jennifer; Atkinson, Thomas M; Abernethy, Amy P; Bruner, Deborah W; Cleeland, Charles S; Sloan, Jeff A; Chilukuri, Ram; Baumgartner, Paul; Denicoff, Andrea; St Germain, Diane; O'Mara, Ann M; Chen, Alice; Kelaghan, Joseph; Bennett, Antonia V; Sit, Laura; Rogak, Lauren; Barz, Allison; Paul, Diane B; Schrag, Deborah

    2014-09-01

    The standard approach for documenting symptomatic adverse events (AEs) in cancer clinical trials involves investigator reporting using the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE). Because this approach underdetects symptomatic AEs, the NCI issued two contracts to create a patient-reported outcome (PRO) measurement system as a companion to the CTCAE, called the PRO-CTCAE. This Commentary describes development of the PRO-CTCAE by a group of multidisciplinary investigators and patient representatives and provides an overview of qualitative and quantitative studies of its measurement properties. A systematic evaluation of all 790 AEs listed in the CTCAE identified 78 appropriate for patient self-reporting. For each of these, a PRO-CTCAE plain language term in English and one to three items characterizing the frequency, severity, and/or activity interference of the AE were created, rendering a library of 124 PRO-CTCAE items. These items were refined in a cognitive interviewing study among patients on active cancer treatment with diverse educational, racial, and geographic backgrounds. Favorable measurement properties of the items, including construct validity, reliability, responsiveness, and between-mode equivalence, were determined prospectively in a demographically diverse population of patients receiving treatments for many different tumor types. A software platform was built to administer PRO-CTCAE items to clinical trial participants via the internet or telephone interactive voice response and was refined through usability testing. Work is ongoing to translate the PRO-CTCAE into multiple languages and to determine the optimal approach for integrating the PRO-CTCAE into clinical trial workflow and AE analyses. It is envisioned that the PRO-CTCAE will enhance the precision and patient-centeredness of adverse event reporting in cancer clinical research.

  20. Patient-Reported Outcome Results From the Open-Label Phase III AURELIA Trial Evaluating Bevacizumab-Containing Therapy for Platinum-Resistant Ovarian Cancer

    PubMed Central

    Stockler, Martin R.; Hilpert, Felix; Friedlander, Michael; King, Madeleine T.; Wenzel, Lari; Lee, Chee Khoon; Joly, Florence; de Gregorio, Nikolaus; Arranz, José Angel; Mirza, Mansoor Raza; Sorio, Roberto; Freudensprung, Ulrich; Sneller, Vesna; Hales, Gill; Pujade-Lauraine, Eric

    2014-01-01

    Purpose To determine the effects of bevacizumab on patient-reported outcomes (PROs; secondary end point) in the AURELIA trial. Patients and Methods Patients with platinum-resistant ovarian cancer were randomly assigned to chemotherapy alone (CT) or with bevacizumab (BEV-CT). PROs were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Ovarian Cancer Module 28 (EORTC QLQ-OV28) and Functional Assessment of Cancer Therapy–Ovarian Cancer symptom index (FOSI) at baseline and every two or three cycles (8/9 weeks) until disease progression. The primary PRO hypothesis was that more patients receiving BEV-CT than CT would achieve at least a 15% (≥ 15-point) absolute improvement on the QLQ-OV28 abdominal/GI symptom subscale (items 31-36) at week 8/9. Patients with missing week 8/9 questionnaires were included as unimproved. Questionnaires from all assessments until disease progression were analyzed using mixed-model repeated-measures (MMRM) analysis. Sensitivity analyses were used to determine the effects of differing assumptions and methods for missing data. Results Baseline questionnaires were available from 89% of 361 randomly assigned patients. More BEV-CT than CT patients achieved a ≥ 15% improvement in abdominal/GI symptoms at week 8/9 (primary PRO end point, 21.9% v 9.3%; difference, 12.7%; 95% CI, 4.4 to 20.9; P = .002). MMRM analysis covering all time points also favored BEV-CT (difference, 6.4 points; 95% CI, 1.3 to 11.6; P = .015). More BEV-CT than CT patients achieved ≥ 15% improvement in FOSI at week 8/9 (12.2% v 3.1%; difference, 9.0%; 95% CI, 2.9% to 15.2%; P = .003). Sensitivity analyses gave similar results and conclusions. Conclusion Bevacizumab increased the proportion of patients achieving a 15% improvement in patient-reported abdominal/GI symptoms during chemotherapy for platinum-resistant ovarian cancer. PMID:24687829

  1. Developing IntegRATE: a fast and frugal patient-reported measure of integration in health care delivery

    PubMed Central

    Elwyn, Glyn; Thompson, Rachel; John, Roshen; Grande, Stuart W

    2015-01-01

    Background Efforts have been made to measure integration in health care delivery, but few existing instruments have adopted a patient perspective, and none is sufficiently generic and brief for administration at scale. We sought to develop a brief and generic patient-reported measure of integration in health care delivery. Methods Drawing on both existing conceptualisations of integrated care and research on patients’ perspectives, we chose to focus on four distinct domains of integration: information sharing, consistent advice, mutual respect and role clarity. We formulated candidate items and conducted cognitive interviews with end users to further develop and refine the items. We then pilot-tested the measure. Results Four rounds of cognitive interviews were conducted (n = 14) and resulted in a four-item measure that was both relevant and understandable to end users. The pilot administration of the measure (n = 15) further confirmed the relevance and interpretability of items and demonstrated that the measure could be completed in less than one minute. Conclusions This new measure, IntegRATE, represents a patient-reported measure of integration in health care delivery that is conducive to use in both routine performance monitoring and research. The psychometric properties of the measure will be assessed in the next stage of development. PMID:26034467

  2. Patient-Reported Outcomes Following Breast Reconstruction Surgery and Therapeutic Mammoplasty: Prospective Evaluation 1 Year Post-Surgery with BREAST-Q Questionnaire.

    PubMed

    Shekhawat, Laxmi; Busheri, Laleh; Dixit, Santosh; Patel, Chaula; Dhar, Upendra; Koppiker, Chaitanyanand

    2015-12-01

    Breast Cancer (BC) treatment leads to mutilation and destruction of breast shape with negative effects on body image and self-esteem.One of the main goals of reconstructive and oncoplastic breast surgery is to satisfy patients and improve their quality of life (QoL).Therefore, it is important to assess the patient experience post-surgery by means of patient-reported outcome measures (PROMs) that focus on the patient's perception of the surgery and surgical care, as well as psychosocial well-being and physical functioning. The objective of the current study was to identify predictors of patient satisfaction such as breast appearance including implant type in a selective sample of women who underwent breast reconstruction surgery using implants. Participants in this prospective study were women, (age 26-75 years) that were newly diagnosed with breast carcinoma. All consecutive patients who underwent breast reconstruction between January 2013 and October 2014 were asked to complete the BREAST-Q questionnaire 1 year after surgery. 120 patients underwent unilateral breast reconstruction using implant. While 38 patients underwent reconstruction with opposite breast reduction symmertization, 27 patients underwent therapeutic mammoplasty. The response rate for BREAST-Q questionnaire completion was 98 % with 147 out of 150 study participants completed the questionnaire. From the data collected from 147 patients, the responses could be distributed into 4 distinct groups based on the reconstruction outcomes namely "very much satisfied" (93 %) or "definitely and mostly satisfied" (94 %) or "satisfied" with the outcome (88 %) or "definitely agree on having reconstruction rather than the alternative of having no breast "(91 %).The results showed significant improvement in all four areas that were evaluated after surgery namely satisfaction with the appearance of the breasts, psychosocial, sexual and physical well-being. While the reconstruction surgery had an overall

  3. Patient-reported outcomes among patients using exenatide twice daily or insulin in clinical practice in six European countries: the CHOICE prospective observational study

    PubMed Central

    2013-01-01

    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 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 countries. Patients initiated exenatide twice daily (BID) or insulin based on a physician’s clinical judgement. Clinical and PRO data were collected at baseline (injectable therapy initiation) and after approximately 3, 6, 12, 18 and 24 months. The two treatment cohorts had different baseline characteristics; therefore, no statistical comparisons of endpoints between main cohorts were conducted. Results There were 2388 patients eligible for analysis (exenatide BID cohort, n = 1114; insulin cohort, n = 1274). Mean positive changes in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) total score and EuroQoL5-Dimension (EQ-5D) index and visual analogue scale (VAS) scores were observed in both cohorts with most changes observed during the first 6 months after injectable therapy initiation. Patients who experienced weight loss (≥1 kg) at 24 months appeared to have higher mean improvements in IWQOL-Lite total score than did patients with weight gain or no weight change. Patients who met the composite clinical endpoint of glycated haemoglobin (HbA1c) <7.0%, no weight gain (≤1 kg) and no hypoglycaemia generally experienced higher mean improvements in EQ-5D index and VAS scores (compared with patients 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

  4. Tophus measurement as an outcome measure for clinical trials of chronic gout: progress and research priorities.

    PubMed

    Dalbeth, Nicola; McQueen, Fiona M; Singh, Jasvinder A; MacDonald, Patricia A; Edwards, N Lawrence; Schumacher, H Ralph; Simon, Lee S; Stamp, Lisa K; Neogi, Tuhina; Gaffo, Angelo L; Khanna, Puja P; Becker, Michael A; Taylor, William J

    2011-07-01

    Despite the recognition that tophus regression is an important outcome measure in clinical trials of chronic gout, there is no agreed upon method of tophus measurement. A number of methods have been used in clinical trials of chronic gout, from simple physical measurement techniques to more complex advanced imaging methods. This article summarizes methods of tophus measurement and discusses their properties. Physical measurement using Vernier calipers meets most aspects of the Outcome Measures in Rheumatology (OMERACT) filter. Rigorous testing of the complex methods, particularly with respect to reliability and sensitivity to change, is needed to determine the appropriate use of these methods. Further information is also required regarding which method of physical measurement is best for use in future clinical trials. The need to develop and test a patient-reported outcome measure of tophus burden is also highlighted.

  5. Quality of Data Entry Using Single Entry, Double Entry and Automated Forms Processing–An Example Based on a Study of Patient-Reported Outcomes

    PubMed Central

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

    2012-01-01

    Background 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 forms processing may be an alternative, but further validation is warranted. Methods 200 patients were randomly selected from a cohort of 5777 patients who had previously answered two different questionnaires. The questionnaires were scanned using an automated forms processing technique, as well as processed by single and double manual data entry, using the EpiData Entry data entry program. The main outcome measure was the proportion of correctly entered numbers at question, form and study level. Results Manual double-key data entry (error proportion per 1000 fields = 0.046 (95% CI: 0.001–0.258)) performed better than single-key data entry (error proportion per 1000 fields = 0.370 (95% CI: 0.160–0.729), (p = 0.020)). There was no statistical difference between Optical Mark Recognition (error proportion per 1000 fields = 0.046 (95% CI: 0.001–0.258)) and double-key data entry (p = 1.000). With the Intelligent Character Recognition method, there was no statistical difference compared to single-key data entry (error proportion per 1000 fields = 6.734 (95% CI: 0.817–24.113), (p = 0.656)), as well as double-key data entry (error proportion per 1000 fields = 3.367 (95% CI: 0.085–18.616)), (p = 0.319)). Conclusions Automated forms processing is a valid alternative to double manual data entry for highly structured forms containing only check boxes, numerical codes and no dates. Automated forms processing can be superior to single manual data entry through a data entry program, depending on the method chosen. PMID:22493733

  6. Clinical Outcome Measures in Chiari I Malformation.

    PubMed

    Yarbrough, Chester K; Greenberg, Jacob K; Park, Tae Sung

    2015-10-01

    Chiari malformation type 1 (CM-I) is a common and often debilitating neurologic disease. Reliable evaluation of treatments has been hampered by inconsistent use of clinical outcome measures. A variety of outcome measurement tools are available, although few have been validated in CM-I. The recent development of the Chicago Chiari Outcome Scale and the Chiari Symptom Profile provides CM-I-specific instruments to measure outcomes in adults and children, although validation and refinement may be necessary.

  7. Measurement outcomes from hip simulators.

    PubMed

    de Villiers, Danielle; Shelton, Julia C

    2016-05-01

    Simulation of wear in total hip replacements has been recognised as an important factor in determining the likelihood of clinical success. However, accurate measurement of wear can be problematic with factors such as number and morphology of wear particles produced as well as ion release proving more important in the biological response to hip replacements than wear volume or wear rate alone. In this study, hard-on-hard (CoCr alloy, AgCrN coating) and hard-on-soft (CoCr alloy and CrN coating on vitamin E blended highly cross-linked polyethylene) bearing combinations were tested in an orbital hip simulator under standard and some adverse conditions. Gravimetric wear rates were determined for all bearings, with cobalt and where applicable, silver release determined throughout testing. Isolation of wear particles from the lubricating fluid was used to determine the influence of different bearing combinations and wear conditions on particle morphology. It was found that cobalt and silver could be measured in the lubricating fluid even when volumetric wear was not detectable. In hard-on-hard bearings, Pearson's correlation of 0.98 was established between metal release into the lubricating fluid and wear volume. In hard-on-soft bearings, coating the head did not influence the polyethylene wear rates measured under standard conditions but did influence the cobalt release; the diameter influenced both polyethylene wear and cobalt release, and the introduction of adverse testing generated smaller polyethylene particles. While hip simulators can be useful to assess the wear performance of a new material or design, measurement of other outcomes may yield greater insight into the clinical behaviour of the bearings in vivo. PMID:26888886

  8. Outcome measures in inflammatory rheumatic diseases

    PubMed Central

    2009-01-01

    Inflammatory rheumatic diseases are generally multifaceted disorders and, therefore, measurement of multiple outcomes is relevant to most of these diseases. Developments in outcome measures in the rheumatic diseases are promoted by the development of successful treatments. Outcome measurement will increasingly deal with measurement of low levels of disease activity and avoidance of disease consequences. It is an advantage for patient management and knowledge transfer if the same outcomes are used in practice and in trials. Continuous measures of change are generally the most powerful and, therefore, are preferred as primary outcomes in trials. For daily clinical practice, outcome measures should reflect the patients' state and have to be easily derivable. The objective of this review is to describe recent developments in outcome measures for inflammatory rheumatic diseases for trials and clinical practice, with an emphasis on rheumatoid arthritis. PMID:19849821

  9. Response Rates for Patient-Reported Outcomes Using Web-Based Versus Paper Questionnaires: Comparison of Two Invitational Methods in Older Colorectal Cancer Patients

    PubMed Central

    Vissers, Pauline AJ; Mols, Floortje; Thong, Melissa SY; van de Poll-Franse, Lonneke V

    2015-01-01

    Background Improving questionnaire response rates is an everlasting issue for research. Today, the Internet can easily be used to collect data quickly. However, collecting data on the Internet can lead to biased samples because not everyone is able to access or use the Internet. The older population, for example, is much less likely to use the Internet. The Patient-Reported Outcomes Following Initial Treatment and Long-Term Evaluation of Survivorship (PROFILES) registry offers a platform to collect Web-based and paper questionnaires and to try different measures to improve response rates. Objective In this study, our aim was to study the influence of two methods of invitation on the response rate. Our second aim was to examine the preference of questionnaire mode of administration (paper or Web-based) for the older patient in particular. Methods To test these two invitational methods, 3406 colorectal cancer patients between ages 18 and 85 years received an invitation containing an access code for the Web-based questionnaire. They could also request a paper questionnaire with an included reply card (paper-optional group). In contrast, 179 randomly selected colorectal cancer patients received a paper questionnaire with the invitation (paper-included group). They could also choose to fill out the Web-based questionnaire with the included access code. Results Response rates did not differ between the paper-optional and the paper-included groups (73.14%, 2491/3406 and 74.9%, 134/179, P=.57). In the paper-optional group, online response was significantly higher when compared to the paper-included group (41.23%, 1027/2491 vs 12.7%, 17/134, P<.001). The majority of online respondents responded after the first invitation (95.33%, 979/1027), which was significantly higher than the paper respondents (52.19%, 764/1464, P<.001). Respondents aged 70 years and older chose to fill out a paper questionnaire more often (71.0%, 677/954). In the oldest age group (≥80 years), 18

  10. Association between number of prostate biopsies and patient-reported functional outcomes after radical prostatectomy: implications for active surveillance protocols

    PubMed Central

    Anderson, Christopher B.; Tin, Amy L.; Sjoberg, Daniel D.; Mulhall, John P.; Sandhu, Jaspreet; Laudone, Vincent P.; Eastham, James A.; Scardino, Peter T.; Ehdaie, Behfar

    2016-01-01

    Purpose Men with prostate cancer who progress on active surveillance (AS) are subject to multiple prostate biopsies prior to radical prostatectomy (RP). Our objective was to evaluate whether the number of preoperative prostate biopsies affects functional outcomes after RP. Materials and methods We identified men treated with RP at our institution between 2008 and 2011. At 6 and 12 months post-operatively, patients completed questionnaires assessing erectile and urinary function. Men with preoperative incontinence or erectile dysfunction or who did not complete the questionnaire were excluded. Primary outcomes were urinary and erectile function at 12 months postoperatively. We used logistic regression to estimate the impact of number of prostate biopsies on functional outcomes after adjusting for demographic and clinical factors. Results We identified 2,712 men treated with RP between 2008 and 2011. Most men (80%) had 1 preoperative prostate biopsy, 16% had 2, and 4% had at least 3. On adjusted analysis, erectile function at 12 months was not significantly different for men with 2 (OR 1.25; 95% CI 0.90, 1.75) or 3 or more (OR 1.52; 95% CI 0.84, 2.78) biopsies, compared to those with 1. Similarly, urinary function at 12 months was not significantly different for men with 2 (0.84, 95% CI 0.64, 1.10) or 3 or more (0.99, 95% CI 0.60, 1.61) biopsies compared to those with 1. Conclusions We did not find evidence that more preoperative prostate biopsies adversely affected erectile or urinary function at 12 months following RP. PMID:26118438

  11. Treatment adherence and other patient-reported outcomes as cost determinants in multiple sclerosis: a review of the literature

    PubMed Central

    Lizán, Luis; Comellas, Marta; Paz, Silvia; Poveda, José Luis; Meletiche, Dennis M; Polanco, Carlos

    2014-01-01

    Background Treatment adherence is one of the key factors for achieving optimal clinical outcomes. In order to assess costs related to adherence to, and persistence and compliance with, disease-modifying therapies (DMTs) in patients with multiple sclerosis (MS), a narrative review of the literature was performed. Satisfaction with and preference for DMTs and their delivery devices were also assessed, as both can have an influence on patients’ adherence and persistence. Methods Electronic databases (MEDLINE, PubMed, Google Scholar, congress proceedings) were searched to identify publications analyzing MS costs related to adherence, persistence, satisfaction, and preferences for MS treatments. Bibliographic references were hand searched. English or Spanish studies published between January 2007 and January 2013 were selected. Results A total of 398 titles were identified, of which 12 met the inclusion criteria. Six studies evaluated the impact of adherence, persistence, and compliance on treatment costs; four publications analyzed satisfaction with DMTs; and two assessed treatment preferences based on attributes of the delivery device. Increased adherence and persistence were associated with better clinical outcomes, leading to lower relapse risk (odds ratio [OR]: 0.71; 95% confidence interval [CI]: 0.59–0.85) and a decrease in health care resource use, such as MS-related hospitalizations (OR: 0.63; 95% CI: 0.47–0.83) and emergency department visits (OR: 0.80; 95% CI: 0.60–1.07). This reduction in resource use led to a patient/year total cost reduction (excluding DMT costs) of up to 22%. Conclusion This review highlights the importance of ensuring adequate adherence in MS patients through treatments and devices better tailored to patients’ needs that could enhance clinical outcomes and reduce MS costs. Understanding the factors underlying satisfaction and compliance with treatment and patients’ preference for certain therapies could help in the development

  12. Effects of neuromuscular training (NEMEX-TJR) on patient-reported outcomes and physical function in severe primary hip or knee osteoarthritis: a controlled before-and-after study

    PubMed Central

    2013-01-01

    Background The benefits of exercise in mild and moderate knee or hip osteoarthritis (OA) are apparent, but the evidence in severe OA is less clear. We recently reported that neuromuscular training was well tolerated and feasible in patients with severe primary hip or knee OA. The aims of this controlled before-and-after study were to compare baseline status to an age-matched population-based reference group and to examine the effects of neuromuscular training on patient-reported outcomes and physical function in patients with severe primary OA of the hip or knee. Methods 87 patients (60–77 years) with severe primary OA of the hip (n = 38, 55% women) or knee (n = 49, 59% women) awaiting total joint replacement (TJR) had supervised, neuromuscular training (NEMEX-TJR) in groups with individualized level and progression of training. A reference group (n = 43, 53% women) was included for comparison with patients’ data. Assessments included self-reported outcomes (HOOS/KOOS) and measures of physical function (chair stands, number of knee bends/30 sec, knee extensor strength, 20-meter walk test) at baseline and at follow-up before TJR. Analysis of covariance (ANCOVA) was used for comparing patients and references and elucidating influence of demographic factors on change. The paired t-test was used for comparisons within groups. Results At baseline, patients reported worse scores than the references in all HOOS/KOOS subscales (hip 27–47%, knee 14–52%, of reference scores, respectively) and had functional limitations (hip 72–85%, knee 42–85%, of references scores, respectively). NEMEX-TJR (mean 12 weeks (SD 5.6) of training) improved self-reported outcomes (hip 9–29%, knee 7–20%) and physical function (hip 3–18%, knee 5–19%) (p < 0.005). Between 42% and 62% of hip OA patients, and 39% and 61% of knee OA patients, displayed a clinically meaningful improvement (≥15%) in HOOS/KOOS subscales by training. The improvement in HOOS

  13. Incorporating the patient’s voice into electronic health records through patient-reported outcomes as the “review of systems”

    PubMed Central

    Basch, Ethan M

    2015-01-01

    Owing to lack of standardization for eliciting patient symptoms, the limited time available during clinical encounters, and the often-competing priorities of patients and providers, providers may not appreciate the full spectrum of the patient’s symptom experience. Using electronically collected patient-reported outcomes to capture the review of system outside of the clinic visit may not only improve the efficiency, completeness, and accuracy of data collection for the review of system, but also provide the opportunity to operationalize incorporating the patient’s voice into the electronic health record. While the necessary technology is already available, multiple stakeholders, including electronic health record vendors, clinicians, researchers, and professional societies, need to align their interests before this can become a widespread reality. PMID:25614143

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

    PubMed

    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.

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

    PubMed Central

    Diener, Lawrence W.; Nahm, Meredith; Weinfurt, Kevin P.

    2013-01-01

    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 fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies. PMID:20703765

  16. Development and preliminary evaluation of a training workshop for the collection of patient-reported outcome (PRO) interview data by research support staff.

    PubMed

    Atkinson, Thomas M; Hurley, Karen; Bylund, Carma L; Berk, Alexandra; Diminni, Kimberly; Ostroff, Jamie S

    2013-03-01

    This paper describes the development and initial evaluation of a didactic curriculum to prepare research support staff with the core knowledge and skills required to collect patient-reported outcomes (PROs) via interviews. Research support staff members (N = 77) were recruited for eight separate workshops, each consisting of a didactic presentation followed by role-play scenarios with trained actors depicting common scenarios they may encounter as part of patient interaction. Trainees were observed and received feedback on their performance from trained facilitators and peers. In comparison to their pre-training assessment, trainees showed significant improvement in their confidence to conduct a research interview, handle a distressed participant, manage a wandering interview, ask participants sensitive questions, and handle irritated patients. Training research support staff in the effective collection of PROs via patient interviews can improve the confidence of these individuals in interacting with patients, which can ultimately lead to increased accuracy of data collection. PMID:23090591

  17. Harnessing Technology to Improve Clinical Trials: Study of Real-Time Informatics to Collect Data, Toxicities, Image Response Assessments, and Patient-Reported Outcomes in a Phase II Clinical Trial

    PubMed Central

    Pietanza, M. Catherine; Basch, Ethan M.; Lash, Alex; Schwartz, Lawrence H.; Ginsberg, Michelle S.; Zhao, Binsheng; Shouery, Marwan; Shaw, Mary; Rogak, Lauren J.; Wilson, Manda; Gabow, Aaron; Latif, Marcia; Lin, Kai-Hsiung; Wu, Qinfei; Kass, Samantha L.; Miller, Claire P.; Tyson, Leslie; Sumner, Dyana K.; Berkowitz-Hergianto, Alison; Sima, Camelia S.; Kris, Mark G.

    2013-01-01

    Purpose In clinical trials, traditional monitoring methods, paper documentation, and outdated collection systems lead to inaccuracies of study information and inefficiencies in the process. Integrated electronic systems offer an opportunity to collect data in real time. Patients and Methods We created a computer software system to collect 13 patient-reported symptomatic adverse events and patient-reported Karnofsky performance status, semi-automated RECIST measurements, and laboratory data, and we made this information available to investigators in real time at the point of care during a phase II lung cancer trial. We assessed data completeness within 48 hours of each visit. Clinician satisfaction was measured. Results Forty-four patients were enrolled, for 721 total visits. At each visit, patient-reported outcomes (PROs) reflecting toxicity and disease-related symptoms were completed using a dedicated wireless laptop. All PROs were distributed in batch throughout the system within 24 hours of the visit, and abnormal laboratory data were available for review within a median of 6 hours from the time of sample collection. Manual attribution of laboratory toxicities took a median of 1 day from the time they were accessible online. Semi-automated RECIST measurements were available to clinicians online within a median of 2 days from the time of imaging. All clinicians and 88% of data managers felt there was greater accuracy using this system. Conclusion Existing data management systems can be harnessed to enable real-time collection and review of clinical information during trials. This approach facilitates reporting of information closer to the time of events, and improves efficiency, and the ability to make earlier clinical decisions. PMID:23630218

  18. Measuring the General Education Outcomes: Practical Strategies.

    ERIC Educational Resources Information Center

    Peterson, Anne; And Others

    Prepared in an effort to more clearly define and measure general education outcomes at Columbus State Community College, in Ohio, this handbook describes outcomes and associated student behaviors and provides suggestions for assessing the outcomes. Following introductory materials, a list is provided of the college's six general education…

  19. Pelvic Floor Disorders Registry: Study Design and Outcome Measures.

    PubMed

    Weber LeBrun, Emily; Adam, Rony A; Barber, Matthew D; Boyles, Sarah Hamilton; Iglesia, Cheryl B; Lukacz, Emily S; Moalli, Pamela; Moen, Michael D; Richter, Holly E; Subak, Leslee L; Sung, Vivian W; Visco, Anthony G; Bradley, Catherine S

    2016-01-01

    Pelvic floor disorders affect up to 24% of adult women in the United States, and many patients with pelvic organ prolapse (POP) choose to undergo surgical repair to improve their quality of life. While a variety of surgical repair approaches and techniques are utilized, including mesh augmentation, there is limited comparative effectiveness and safety outcome data guiding best practice. In conjunction with device manufacturers, federal regulatory organizations, and professional societies, the American Urogynecologic Society developed the Pelvic Floor Disorders Registry (PFDR) designed to improve the quality of POP surgery by facilitating quality improvement and research on POP treatments. The PFDR will serve as a resource for surgeons interested in benchmarking and outcomes data and as a data repository for Food and Drug Administration-mandated POP surgical device studies. Provider-reported clinical data and patient-reported outcomes will be collected prospectively at baseline and for up to 3 years after treatment. All data elements including measures of success, adverse events, and surgeon characteristics were identified and defined within the context of the anticipated multifunctionality of the registry, and with collaboration from multiple stakeholders. The PFDR will provide a platform to collect high-quality, standardized patient-level data from a variety of nonsurgical (pessary) and surgical treatments of POP and other pelvic floor disorders. Data from this registry may be used to evaluate short- and longer-term treatment outcomes, patient-reported outcomes, and complications, as well as to identify factors associated with treatment success and failure with the overall goal of improving the quality of care for women with these conditions.

  20. Patient-reported outcomes in type 2 diabetes mellitus: patients’ and primary care physicians’ perspectives in the Spanish health care system

    PubMed Central

    Franch-Nadal, Josep; Labrador Barba, Elena; Gómez-García, M Carmen; Buil-Cosiales, Pilar; Millaruelo, José Manuel; Peña, María Luisa Orera

    2015-01-01

    Objective Understanding patients’ and physicians’ perceptions of type 2 diabetes mellitus (T2DM) management and treatment has important implications for diabetes care, allowing the identification of clinical practice issues that could be improved, leading to patients’ better understanding of the illness and, consequently, healthier self-management behaviors. The objective of this study was to identify differences between physicians’ and T2DM patients’ perceptions related to health status, patient-reported outcomes assessments, and T2DM management and treatment, in routine clinical practice in Spain. Methods This was an observational, cross-sectional study including 1,012 T2DM patients and 974 physicians from 47 and 52 Spanish provinces, respectively. An electronic structured self-administered questionnaire containing 17 questions was designed aiming to address both physicians’ and patient’s perceptions on overall T2DM health status and patient-reported outcomes. Results T2DM patients perceived a worse health status (40% reported having a “good” and 38% a “neither good nor bad” health status) compared with physicians’ perceptions (77% thought patients had a “good” health status). Most patients answered being “satisfied” or “neither satisfied nor unsatisfied” with the given information, while physicians considered that patients were “satisfied” or “very satisfied” with the information for self-monitoring blood glucose and treatment administration. Fifty-seven percent of patients reported that medical recommendations were “important”, while 58% of physicians considered it as “very important”. Fifty-three percent of patients perceived that their current T2DM treatment suited their preferences “quite a lot”, and this was lower than the proportion of physicians (69%) that believed this for their patients. Additionally, a lower percentage of patients (53%) than physicians (79%) believed that their treatment improved

  1. Feasibility of Using a Handheld Electronic Device for the Collection of Patient Reported Outcomes Data from Children

    ERIC Educational Resources Information Center

    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…

  2. Body mass index is not a clinically meaningful predictor of patient reported outcomes of primary hip replacement surgery: prospective cohort study

    PubMed Central

    Judge, Andy; Batra, Rajbir N; Thomas, Geraint; Beard, David; Javaid, M Kassim; Murray, David; Dieppe, Paul A; Dreinhoefer, Karsten; Peter-Guenther, Klaus; Field, Richard; Cooper, Cyrus; Arden, Nigel K

    2014-01-01

    Objectives To describe whether body mass index (BMI) is a clinically meaningful predictor of patient reported outcomes following primary total hip replacement (THR) surgery Design Combined data from prospective cohort studies. We obtained information from four cohorts of patients receiving primary THR for osteoarthritis: Exeter Primary Outcomes Study (n=1431); EUROHIP (n=1327); Elective Orthopaedic Centre (n=2832); and St. Helier (n=787). The exposure of interest was pre-operative BMI. Confounding variables included: age, sex, SF-36 mental health, comorbidities, fixed flexion, analgesic use, college education, OA in other joints, expectation of less pain, radiographic K&L grade, ASA grade, years of hip pain. The primary outcome was the Oxford Hip Score (OHS). Regression models describe the association of BMI on outcome adjusting for all confounders. Results For a 5-unit increase in BMI, the attained 12-month OHS decreases by 0.78 points 95%CI (0.27 to 1.28), p-value 0.001. Compared to people of normal BMI (20 to 25), those in the obese class II (BMI 35 to 40) would have a 12-month OHS that is 2.34 points lower. Although statistically significant this effect is small and not clinically meaningful in contrast to the substantial change in OHS seen across all BMI groupings. In obese class II patients achieved a 22.2 point change in OHS following surgery. Conclusions Patients achieved substantial change in OHS after THR across all BMI categories, which greatly outweighs the small difference in attained post-operative score. The findings suggest BMI should not present a barrier to access THR in terms of PROMs. PMID:24418679

  3. Patient reported outcomes for patients who returned to sport compared with those who did not after hip arthroscopy: minimum 2-year follow-up

    PubMed Central

    Domb, Benjamin G.; Dunne, Kevin F.; Martin, Timothy J.; Gui, Chengcheng; Finch, Nathan A.; Vemula, S. Pavan; Redmond, John M.

    2016-01-01

    Previous studies assessed elite athletes’ return to sport (RTS) after hip arthroscopy, but few investigated a cohort including athletes from all levels of sport. This study compared athletes who returned to sport to those who did not, based on four patient-reported outcome (PRO) scores, including the Hip Outcome Score—Sports Specific Subscale (HOS-SSS). Between September 2008 and April 2012, hip arthroscopies were performed on 157 patients (168 hips) who reported playing a sport preoperatively and indicated their level of sports activity post-operatively. Two-year follow-up was available for 148 (94%) amateur and professional athletes with a total of 158 hips. Of these 60 cases (65 hips) did not return to sports (NRTS) and were in the NRTS group. The remaining 88 cases (93 hips) constituted the RTS group. The modified Harris Hip Score, Non-Arthric Hip Score, Hip Outcome-Activities of Daily Living (HOS-ADL), and HOS-SSS were used to assess outcomes. The HOS-SSS was used to assess specific sport-related movement. Both groups demonstrated significant improvement at 2 years post-operatively in visual analog score and four PRO scores (P < 0.001). There was no significant preoperative differences in HOS-SSS scores between groups; however, the RTS group had significantly higher HOS-SSS scores at 1 and 2 years post-surgery. Post-operatively, the RTS group had significantly better ability to jump, land from a jump, stop quickly and perform cutting/lateral movements (P < 0.05). In summary, patients who indicated RTSs demonstrated significantly higher PRO scores and abilities to perform several sport-related movements, compared with patients who did not. PMID:27583148

  4. Patient reported outcomes for patients who returned to sport compared with those who did not after hip arthroscopy: minimum 2-year follow-up.

    PubMed

    Domb, Benjamin G; Dunne, Kevin F; Martin, Timothy J; Gui, Chengcheng; Finch, Nathan A; Vemula, S Pavan; Redmond, John M

    2016-07-01

    Previous studies assessed elite athletes' return to sport (RTS) after hip arthroscopy, but few investigated a cohort including athletes from all levels of sport. This study compared athletes who returned to sport to those who did not, based on four patient-reported outcome (PRO) scores, including the Hip Outcome Score-Sports Specific Subscale (HOS-SSS). Between September 2008 and April 2012, hip arthroscopies were performed on 157 patients (168 hips) who reported playing a sport preoperatively and indicated their level of sports activity post-operatively. Two-year follow-up was available for 148 (94%) amateur and professional athletes with a total of 158 hips. Of these 60 cases (65 hips) did not return to sports (NRTS) and were in the NRTS group. The remaining 88 cases (93 hips) constituted the RTS group. The modified Harris Hip Score, Non-Arthric Hip Score, Hip Outcome-Activities of Daily Living (HOS-ADL), and HOS-SSS were used to assess outcomes. The HOS-SSS was used to assess specific sport-related movement. Both groups demonstrated significant improvement at 2 years post-operatively in visual analog score and four PRO scores (P < 0.001). There was no significant preoperative differences in HOS-SSS scores between groups; however, the RTS group had significantly higher HOS-SSS scores at 1 and 2 years post-surgery. Post-operatively, the RTS group had significantly better ability to jump, land from a jump, stop quickly and perform cutting/lateral movements (P < 0.05). In summary, patients who indicated RTSs demonstrated significantly higher PRO scores and abilities to perform several sport-related movements, compared with patients who did not. PMID:27583148

  5. Item Response Modeling of Presence-Severity Items: Application to Measurement of Patient-Reported Outcomes

    ERIC Educational Resources Information Center

    Liu, Ying; Verkuilen, Jay

    2013-01-01

    The Presence-Severity (P-S) format refers to a compound item structure in which a question is first asked to check the presence of the particular event in question. If the respondent provides an affirmative answer, a follow-up is administered, often about the frequency, density, severity, or impact of the event. Despite the popularity of the P-S…

  6. Enhanced patient reported outcome measurement suitable for head and neck cancer follow-up clinics

    PubMed Central

    2012-01-01

    Background The ‘Worse-Stable-Better’ (W-S-B) question was introduced to capture patient-perceived change in University of Washington Quality of Life (UW-QOL) domains. Methods 202 head and neck cancer patients in remission prospectively completed UW-QOL and Patients Concerns Inventory (PCI). For each UW-QOL domain, patients indicated whether over the last month things had worsened (W), remained stable (S) or were better (B). Results 202 patients at 448 attendances selected 1752 PCI items they wanted to discuss in consultation, and 58% (1024/1752) of these were not covered by the UW-QOL. UW-QOL algorithms highlighted another 440 significant problems that the patient did not want to discuss (i.e. the corresponding items on the PCI were not selected). After making allowance for UW-QOL algorithms to identify 'significant problems' and PCI selection of corresponding issues for discussion there remained clear residual and notable variation in W-S-B responses, in particular to identify patients with significant problems that were getting worse, and patients without significant problems that wanted to discuss issues that were getting worse. Changes in mean UW-QOL scores were notably lower for those getting worse on the W-S-B question, typically by 10 or more units a magnitude that suggests clinically important changes in score. Conclusions The W-S-B question adds little questionnaire burden and could help to better identify patients who might benefit from intervention. The results of this study suggest that the UW-QOL with the W-S-B modification should be used together with the PCI to allow optimal identification of issues for patient-clinician discussion during routine outpatient clinics. PMID:22695251

  7. Patient-Reported Outcomes and Therapeutic Affordances of Social Media: Findings From a Global Online Survey of People With Chronic Pain

    PubMed Central

    Gray, Kathleen; Martin-Sanchez, Fernando; Lopez-Campos, Guillermo

    2015-01-01

    Background Patient-reported outcomes (PROs) from social media use in chronic disease management continue to emerge. While many published articles suggest the potential for social media is positive, there is a lack of robust examination into mediating mechanisms that might help explain social media’s therapeutic value. This study presents findings from a global online survey of people with chronic pain (PWCP) to better understand how they use social media as part of self-management. Objective Our aim is to improve understanding of the various health outcomes reported by PWCP by paying close attention to therapeutic affordances of social media. We wish to examine if demographics of participants underpin health outcomes and whether the concept of therapeutic affordances explains links between social media use and PROs. The goal is for this to help tailor future recommendations for use of social media to meet individuals’ health needs and improve clinical practice of social media use. Methods A total of 231 PWCP took part in a global online survey investigating PROs from social media use. Recruited through various chronic disease entities and social networks, participants provided information on demographics, health/pain status, social media use, therapeutic affordances, and PROs from use. Quantitative analysis was performed on the data using descriptive statistics, cross-tabulation, and cluster analysis. Results The total dataset represented 218 completed surveys. The majority of participants were university educated (67.0%, 146/218) and female (83.9%, 183/218). More than half (58.7%, 128/218) were married/partnered and not working for pay (75.9%, 88/116 of these due to ill health). Fibromyalgia (46.6%, 55/118) and arthritis (27.1%, 32/118) were the most commonly reported conditions causing pain. Participants showed a clear affinity for social network site use (90.0%, 189/210), followed by discussion forums and blogs. PROs were consistent, suggesting that social

  8. Examining the Impact of Patient-Reported Hope for Improvement and Patient Satisfaction with Clinician/Treatment on the Outcome of Major Depressive Disorder Treatment

    PubMed Central

    Vilhauer, Jennice; Kwock, Richard; Wu, Fan; Gohar, Sherif; Collison, Katherine; Thomas, Shannon Nicole; Naghdechi, Lancer; Elashoff, David

    2016-01-01

    Aims This analysis aims at examining if patient-reported variables such as hope for improvement and patient satisfaction with clinician/treatment could influence the outcome major depressive disorder (MDD) treatment, namely depression remission, in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial. Study Design Retrospective cohort study. Place and Duration of Study The STAR*D study was conducted at 18 primary care and 23 psychiatric care settings in the United States from 2001–2007 and was funded by the National Institute of Mental health (NIMH). The analysis contained in this manuscript was conceptualized at the Cedars-Sinai Department of Psychiatry and Behavioral Neurosciences and performed at the UCLA School of Public Health. Methodology Using data from STAR*D, the current study used logistic regression and survival analyses to examine the relationship between depressive symptoms remission and two sets of self-reported factors: Hope for improvement and, Patient satisfaction with treatment/clinician. Results First, more than 90% of STAR*D patients reported having high hope for improvement (agree or strongly agree) and more than 66% endorsed high satisfaction with clinicians and more than 50% expressed high satisfaction with treatments (very or mostly satisfied). Second, hope for improvement was predictive of depression remission (p<0.05). Third, satisfaction with clinician/treatment, did not predict remission. Conclusion This study shows the impact that patients’ subjective hope for improvement can have on predicting depression remission in contrast to satisfaction with clinician/treatment. Future studies should prospectively incorporate patients’ subjective attitudes regarding hope for improvement and satisfaction with clinicians and treatments as mediators and moderators of MDD treatment success. PMID:27294164

  9. The influence of hamstring autograft size on patient reported outcomes and risk of revision following anterior cruciate ligament reconstruction: A MOON cohort study

    PubMed Central

    Mariscalco, Michael W.; Flanigan, David C.; Mitchell, Joshua; Pedroza, Angela D.; Jones, Morgan H.; Andrish, Jack T.; Parker, Richard D.; Kaeding, Christopher C.; Magnussen, Robert A.

    2013-01-01

    Purpose The purpose of this study is to evaluate the effect of graft size on patient-reported outcomes and revision risk following ACL reconstruction. Methods A retrospective chart review of prospectively collected cohort data, 263 of 320 consecutive patients (82.2%) undergoing primary ACL reconstruction with hamstring autograft were evaluated. Graft size, femoral tunnel drilling technique, patient age, sex, and BMI at the time of ACL reconstruction, pre-operative and 2-year post-operative KOOS and IKDC scores, and whether each patient underwent revision ACL reconstruction during the 2 year follow-up period were recorded. Revision was used as a marker for graft failure. The relationship between graft size and patient-reported outcomes was determined by multiple linear regression. The relationship between graft size and risk of revision was determined by dichotomizing graft size at 8mm and stratifying by age. Results After controlling for age, sex, operative side, surgeon, BMI, graft choice, and femoral tunnel drilling technique, a 1 mm increased in graft size was noted to correlate with 3.3-point increase in the KOOS-pain subscale (p = 0.003), a 2.0-point increased in the KOOS activities of daily living subscale (p = 0.034), a 5.2-point increase in the KOOS-sport/recreation function subscale (p = 0.004), and a 3.4-point increase in the subjective IKDC score (p = 0.026). Revision was required in 0 of 64 patients (0.0%) with grafts greater than 8mm in diameter and 14 of 199 patients (7.0%) with 8 mm or smaller grafts (p = 0.037). Among patients age 18 and under, revision was required in 0 of 14 patients (0.0%) with grafts greater than 8mm in diameter and 13 of 71 patients (18.3 %) with 8 mm or smaller grafts. Conclusions Smaller hamstring autograft size is a predictor of poorer KOOS Sport and Recreation function 2 years following primary ACL reconstruction. Larger sample size is required to confirm the relationship between graft size and risk of revision ACL

  10. Outcome measures for traumatic brain injury.

    PubMed

    Shukla, Dhaval; Devi, B Indira; Agrawal, Amit

    2011-07-01

    Traumatic brain injury (TBI) is a major public health problem resulting in death and disabilities of young and productive people. Though the mortality of TBI has decreased substantially in recent years the disability due to TBI has not appreciably reduced. Various outcome scales have been proposed and used to assess disability after TBI. A few, commonly used are Glasgow Outcome Scale (GOS) with or without extended scores, Disability Rating Scale (DRS), Functional Independence Measure (FIM), Community Integration Questionnaire (CIQ), and the Functional Status Examination (FSE). These scales assess disability resulting from physical and cognitive impairments. For patients with good physical recovery a cognitive and neuropsychological outcome measure is required. Such measures include Neurobehavioural Function Inventory and specific neuropsychological tests like Rey Complex Figure for visuoconstruction and memory, Controlled Oral Word Association for verbal fluency, Symbol Digit Modalities (verbal) for sustained attention and Grooved Pegboard for fine motor dexterity. A more holistic and complete outcome measure is Quality of Life (QOL). Disease specific QOL measure for TBI, Quality of Life after Brain Injury (QOLIBRI) has also been recently proposed. The problems with outcome measures include poor operational definitions, lack of sensitivity or low ceiling effects, inability to evaluate patients who cannot report, lack of integration of morbidity and mortality categories, and limited domains of functioning assessed. GOSE-E satisfies most of the criteria of good outcome scale and in combination with neuropsychological tests is a near complete instrument for assessment of outcome after TBI. PMID:21440363

  11. Functional Outcome Measures for Knee Dysfunction Assessment

    PubMed Central

    Keskula, Douglas R.; Duncan, Jewell B.; Davis, Virginia L.; Finley, Paula W.

    1996-01-01

    Maximizing the functional abilities of the individual is the primary objective of any therapeutic intervention. Functional outcome data are valuable to those involved in the care of the athlete because such data provides information that helps facilitate the clinical decision-making process and, therefore, helps insure a safe and efficient return to athletics. Functional outcome measures also provide useful data for assessing therapeutic intervention efficacy. The clinician/researcher must consider various factors when selecting an appropriate outcome measure, such as: the patient population, pathology, specific test parameters, psychometric properties, and practicality of the measure. The primary purpose of this paper is to provide the reader with guidelines for either assessing existing measures or developing new measures of functional outcomes for use in clinical practice and research. PMID:16558382

  12. Measuring Inclusive Education Outcomes in Alberta, Canada

    ERIC Educational Resources Information Center

    Loreman, Tim

    2014-01-01

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

  13. Using R and WinBUGS to fit a Generalized Partial Credit Model for developing and evaluating patient-reported outcomes assessments

    PubMed Central

    Li, Yuelin; Baser, Ray

    2013-01-01

    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 in IRT (GPCM). 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. PMID:22362655

  14. Quality of Patient-Reported Outcome (PRO) Reporting Across Cancer Randomized Controlled Trials According to the CONSORT PRO Extension: A Pooled Analysis of 557 Trials

    PubMed Central

    Efficace, Fabio; Fayers, Peter; Pusic, Andrea; Cemal, Yeliz; Yanagawa, Jane; Jacobs, Marc; la Sala, Andrea; Cafaro, Valentina; Whale, Katie; Rees, Jonathan; Blazeby, Jane

    2016-01-01

    Background The main objectives of this study were to identify the number of randomized controlled trials (RCTs) that have included a patient-reported outcome (PRO) endpoint across a wide range of cancer specialties and to evaluate completeness of PRO reporting according to the CONSORT PRO extension. Methods RCTs with a PRO endpoint, conducted across several cancer specialties and published between 2004 and 2013 were considered. Studies were evaluated based on previously defined criteria, including the CONSORT PRO extension and the Cochrane Collaboration's tool for assessing RCT Risk of Bias. Analyses were also conducted by type of PRO endpoint (primary versus secondary) and by cancer disease site. Results A total of 56,696 potentially eligible records were scrutinized and 557 RCTs with a PRO evaluation, enrolling overall 254,677 patients, were identified. PROs were most frequently used in RCTs of breast (N=123), lung (N=85) and colorectal (N=66) cancer. Overall, PROs were secondary endpoint in 421 (76%) RCTs. Four out of six CONSORT PRO items evaluated were documented in less than 50% of the RCTs. Level of reporting was higher in RCTs with PRO as a primary endpoint. Presence of a supplementary report was the only statistically significant factor associated with greater completeness of reporting for both RCTs with PRO as primary (β=0.19; P=0.001) or secondary endpoint (β=0.30; P<0.001). Conclusion Implementation of the CONSORT PRO extension is equally important across all cancer specialties. Its use can also contribute in revealing the robust PRO design of some studies, which might be obscured by poor outcome reporting. PMID:26079197

  15. Cross-cultural adaptation and linguistic validation of age-group-specific haemophilia patient-reported outcome (PRO) instruments for patients and parents.

    PubMed

    von Mackensen, S; Campos, I G; Acquadro, C; Strandberg-Larsen, M

    2013-03-01

    Currently, haemophilia care aims to provide the best possible quality of life for individuals living with this chronic disease. Many factors are known to influence treatment adherence, including treatment satisfaction. Health-related quality of life (HRQoL) and treatment satisfaction are, therefore, important outcomes in clinical trials and clinical practice. As individuals' perception of their well-being often differs from that of their physician, it is recommended that self-report instruments are used to assess patient-reported outcomes (PROs). The way that the impact of haemophilia is perceived by the patient and their family can be different, so it is important to assess how parents perceive the impact on their children. A series of PRO instruments have been developed, adapted to different age groups and parents of patients with haemophilia. To allow the instruments to be used internationally, culturally adapted and linguistically validated translations have been developed; some instruments have been translated into 61 languages. Here, we report the process used for cultural adaptation of the Haemo-QoL, Haem-A-QoL and Hemo-Sat into 28 languages. Equivalent concepts for 22 items that were difficult to adapt culturally for particular languages were identified and classed as semantic/conceptual (17 items), cultural (three items), idiomatic (one item), and grammatical (one item) problems. This has resulted in linguistically validated versions of these instruments, which can be used to assess HRQoL and treatment satisfaction in clinical trials and clinical practice. They will provide new insights into areas of haemophilia that remain poorly understood today. PMID:23167873

  16. Addressing the “It Is Just Placebo” Pitfall in CAM: Methodology of a Project to Develop Patient-Reported Measures of Nonspecific Factors in Healing

    PubMed Central

    Greco, Carol M.; Glick, Ronald M.; Morone, Natalia E.; Schneider, Michael J.

    2013-01-01

    CAM therapies are often dismissed as “no better than placebo;” however, this belief may be overcome through careful analysis of nonspecific factors in healing. To improve trial methodology, we propose that CAM (and conventional) RCTs should evaluate and adjust for the effects of intrapersonal, interpersonal, and environmental factors on outcomes. However, measurement of these is challenging, and there are no brief, precise instruments that are suitable for widespread use in trials and clinical settings. This paper describes the methodology of a project to develop a set of patient-reported instruments that will quantify the nonspecific or “placebo” effects that are in fact specific and active ingredients in healing. The project uses the rigorous instrument-development methodology of the NIH-PROMIS initiative. The methods include (1) integration of patients' and clinicians' opinions with existing literature; (2) development of relevant items; (3) calibration of items on large samples; (4) classical test theory and modern psychometric methods to select the most useful items; (5) development of computerized adaptive tests (CATs) that maximize information while minimizing patient burden; and (6) initial validation studies. The instruments will have the potential to revolutionize clinical trials in both CAM and conventional medicine through quantifying contextual factors that contribute to healing. PMID:24454501

  17. [Roaming through methodology. XXV. Outcome measures, surrogate outcomes, and intermediate measures].

    PubMed

    Boers, M

    2000-10-01

    Clinical medicine is aimed at decreasing the current or future burden of disease. Disease outcome is best expressed as burden of disease or change thereof, and as such the only true 'outcome measure' in clinical research. However, outcome research is expensive in costs and time expenditure, and sometimes impossible. Therefore study results are often expressed in intermediate measures. These measures tell us something about the disease process and the pathophysiological consequences of the disease and should have a relation with outcome. If this relation is strong, the measure is called 'surrogate outcome'. Intermediate measures and surrogate outcomes have advantages and disadvantages. The reader of clinical trial results first has to decide whether the answer to the study question is relevant in his personal situation. If so, the applicability of a measure can be simply appraised by answering 3 questions: 'Is the measure truthful (relevant, unbiased)?'; 'Does it discriminate between situations that are of interest?'; 'Is the measure feasible in my setting?' PMID:11048558

  18. PATIENT-REPORTED OUTCOMES OF QUALITY OF LIFE, FUNCTIONING, AND DEPRESSIVE SYMPTOM SEVERITY IN MAJOR DEPRESSIVE DISORDER COMORBID WITH PANIC DISORDER BEFORE AND AFTER SSRI TREATMENT IN THE STAR*D TRIAL

    PubMed Central

    IsHak, Waguih William; Mirocha, James; Christensen, Scott; Wu, Fan; Kwock, Richard; Behjat, Joseph; Pi, Sarah; Akopyan, A.; Peselow, Eric D.; Cohen, Robert M.; Elashoff, David

    2014-01-01

    Background Panic disorder (PD) is highly comorbid with major depressive disorder (MDD) with potential impact on patient-reported outcomes of quality of life (QOL), functioning, and depressive symptom severity Methods Using data from the sequenced treatment alternatives to relieve depression (STAR*D) trial, we compared entry and post-SSRI-treatment QOL, functioning, and depressive symptom severity scores in MDD patients with comorbid PD (MDD+PD) to MDD patients without PD (MDDnoPD). We also compared pre- and posttreatment proportions of patients with severe impairments in quality of life and functioning. Results MDD+PD patients experienced significantly lower QOL and functioning and more severe depressive symptoms than MDDnoPD patients at entry. Following treatment with citalopram, both groups showed significant improvements, however, nearly 30–60% of patients still suffered from severe quality of life and functioning impairments. MDD+PD patients exited with lower QOL and functioning than MDDnoPD patients, a difference that became statistically insignificant after adjusting for baseline measures of depressive symptom severity, functioning, and QOL, comorbid anxiety disorders (PTSD, GAD, social, and specific phobias), age, and college education. Conclusions Functional outcomes using QOL and functioning measures should be utilized in treating and researching MDD so that shortfalls in traditional treatment can be identified and additional interventions can be designed to address severe baseline QOL and functioning deficits in MDD comorbid with PD. PMID:23861180

  19. Outcome measures for acute and chronic gout.

    PubMed

    Schumacher, H Ralph; Edwards, Lawrence N; Perez-Ruiz, Fernando; Becker, Michael; Chen, Lan X; Furst, Daniel E; Joseph-Ridge, Nancy; Schlesinger, Naomi; Horowitz, Zeb; Saag, Kenneth; Boice, Judith A; Yamanaka, Hisashi

    2005-12-01

    Gout provides some unique challenges in classification and measurement of outcomes. Our aim was to evaluate criteria for classification and to develop and validate optimal instruments to measure outcomes for acute and chronic gout. A planning committee and interested attendees met to propose classification criteria and domains for outcomes. Seven of the current American Rheumatism Association preliminary criteria for classification were proposed as the best current criteria for acute gouty arthritis, pending further studies. The presence of gout is best established by crystal identification, although this technique has limitations. Five domains for acute gout outcomes and 9 for chronic gout were identified along with proposed instruments for testing and validation. The unique problems of gout evaluation can and will be addressed.

  20. Outcome measures for vulval skin conditions: a systematic review of randomized controlled trials.

    PubMed

    Simpson, R C; Thomas, K S; Murphy, R

    2013-09-01

    Symptoms and signs of vulval skin disorders are common. These conditions can have a considerable impact on quality of life, restricting physical activities and causing difficulty in everyday activities and may also affect social, psychosexual and psychological well-being. There are no standardized measures routinely used to assess the impact of vulval disease on daily life. To report outcome measures used in clinically based randomized controlled trials (RCTs) investigating therapeutic interventions in vulval disease. The Medline, EMBASE and CENTRAL databases were searched to identify RCTs of vulval skin conditions written in English. Studies with laboratory tests or survival rates as the primary outcome, or those investigating menopausal symptoms or infections were excluded. Twenty-eight published RCTs were included. The vulval conditions represented were vulvodynia (n = 14), lichen sclerosus (n = 9), vulval intraepithelial neoplasia (n = 2), vulval pruritus (n = 2) and lichen planus (n = 1). The 28 RCTs measured 25 different outcomes, using 49 different scales. The method of outcome assessment was lacking on nine occasions. Only 21% (six of 28) of included trials had a clearly stated primary outcome. Patient-reported outcomes were more commonly reported than clinician-related outcome measures. The most commonly reported patient-rated outcome measure was a reduction in pain (measured 15 times) and an overall improvement in symptoms using a patient global assessment (measured 11 times). The most commonly reported clinician-rated outcome was an overall assessment of the appearance of affected sites (measured 13 times). There were no agreed standard scales used for the global assessments. Only nine of the recorded outcome measure tools were designed to assess vulval disease or sexual functioning, the remainder were general measures. There is heterogeneity in the outcome measures used when reporting therapeutic interventions in vulval disease. This field of

  1. Efficacy, safety and patient-reported outcomes of combination etanercept and sulfasalazine versus etanercept alone in patients with rheumatoid arthritis: a double-blind randomised 2-year study

    PubMed Central

    Combe, B; Codreanu, C; Fiocco, U; Gaubitz, M; Geusens, P P; Kvien, T K; Pavelka, K; Sambrook, P N; Smolen, J S; Khandker, R; Singh, A; Wajdula, J; Fatenejad, S

    2009-01-01

    Objective: To determine the efficacy and safety of etanercept and etanercept plus sulfasalazine versus sulfasalazine in patients with rheumatoid arthritis (RA) despite sulfasalazine therapy. Methods: Patients were randomly assigned to etanercept (25 mg twice weekly; sulfasalazine was discontinued at baseline), etanercept plus sulfasalazine (unchanged regimen of 2–3 g/day) or sulfasalazine in a double-blind, randomised, 2-year study in adult patients with active RA despite sulfasalazine therapy. Efficacy was assessed using the American College of Rheumatology criteria, disease activity scores (DAS) and patient-reported outcomes (PRO). Results: Demographic variables and baseline disease characteristics were comparable among treatment groups; mean DAS 5.1, 5.2 and 5.1 for etanercept (n  =  103), etanercept plus sulfasalazine (n  =  101) and sulfasalazine (n  =  50), respectively. Withdrawal due to lack of efficacy was highest with sulfasalazine (26 (52%) vs 6 (6%) for either etanercept group, p<0.001). Patients receiving etanercept or etanercept plus sulfasalazine had a more rapid initial response, which was sustained at 2 years, than those receiving sulfasalazine: mean DAS 2.8, 2.5 versus 4.5, respectively (p<0.05); ACR 20 response was achieved by 67%, 77% versus 34% of patients, respectively (p<0.01) Overall, PRO followed a similar pattern; a clinically significant improvement in health assessment questionnaire was achieved by 76%, 78% versus 40% of patients, respectively (p<0.01). Commonly reported adverse events occurring in the etanercept groups were injection site reactions and pharyngitis/laryngitis (p<0.01). Conclusion: Etanercept and etanercept plus sulfasalazine are efficacious for the long-term management of patients with RA. The addition of etanercept or substitution with etanercept should be considered as treatment options for patients not adequately responding to sulfasalazine. PMID:18794178

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

    PubMed Central

    Johnston, Donna; Gerbing, Robert; Alonzo, Todd; Aplenc, Richard; Nagarajan, Rajaram; Schulte, Fiona; Cullen, Patricia; Sung, Lillian

    2015-01-01

    Purpose 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. Methods 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. Results 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. Conclusion 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. PMID:25915772

  3. Design, implementation and reporting strategies to reduce the instance and impact of missing patient-reported outcome (PRO) data: a systematic review

    PubMed Central

    Mercieca-Bebber, Rebecca; Palmer, Michael J; Brundage, Michael; Stockler, Martin R; King, Madeleine T

    2016-01-01

    Objectives Patient-reported outcomes (PROs) provide important information about the impact of treatment from the patients' perspective. However, missing PRO data may compromise the interpretability and value of the findings. We aimed to report: (1) a non-technical summary of problems caused by missing PRO data; and (2) a systematic review by collating strategies to: (A) minimise rates of missing PRO data, and (B) facilitate transparent interpretation and reporting of missing PRO data in clinical research. Our systematic review does not address statistical handling of missing PRO data. Data sources MEDLINE and Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases (inception to 31 March 2015), and citing articles and reference lists from relevant sources. Eligibility criteria English articles providing recommendations for reducing missing PRO data rates, or strategies to facilitate transparent interpretation and reporting of missing PRO data were included. Methods 2 reviewers independently screened articles against eligibility criteria. Discrepancies were resolved with the research team. Recommendations were extracted and coded according to framework synthesis. Results 117 sources (55% discussion papers, 26% original research) met the eligibility criteria. Design and methodological strategies for reducing rates of missing PRO data included: incorporating PRO-specific information into the protocol; carefully designing PRO assessment schedules and defining termination rules; minimising patient burden; appointing a PRO coordinator; PRO-specific training for staff; ensuring PRO studies are adequately resourced; and continuous quality assurance. Strategies for transparent interpretation and reporting of missing PRO data include utilising auxiliary data to inform analysis; transparently reporting baseline PRO scores, rates and reasons for missing data; and methods for handling missing PRO data. Conclusions The instance of missing PRO data and its

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

    PubMed Central

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

    2016-01-01

    optimising participation. We highlight the potential for informing and evaluating clinical practice and service provision through seeking patient-reported outcomes in paediatric care. PMID:27487183

  5. ‘Trial Exegesis’: Methods for Synthesizing Clinical and Patient Reported Outcome (PRO) Data in Trials to Inform Clinical Practice. A Systematic Review

    PubMed Central

    Macefield, Rhiannon C.; Blencowe, Natalie S.; Brookes, Sara T.; Blazeby, Jane M.

    2016-01-01

    Purpose The CONSORT extension for patient reported outcomes (PROs) aims to improve reporting, but guidance on the optimal integration with clinical data is lacking. This study examines in detail the reporting of PROs and clinical data from randomized controlled trials (RCTs) in gastro-intestinal cancer to inform design and reporting of combined PRO and clinical data from trials to improve the ‘take home’ message for clinicians to use in practice. Materials and Methods The case study was undertaken in gastro-intestinal cancer trials. Well-conducted RCTs reporting PROs with validated instruments were identified and categorized into those combining PRO and clinical data in a single paper, or those separating data into linked primary and supplemental papers. Qualitative methods were developed to examine reporting of the critical interpretation of the trial results (trial exegesis) in the papers in relation of the PRO and clinical outcomes and applied to each publication category. Results were used to inform recommendations for practice. Results From 1917 screened abstracts, 49 high quality RCTs were identified reported in 36 combined and 15 linked primary and supplemental papers. In-depth analysis of manuscript text identified three categories for understanding trial exegesis: where authors reported a “detailed”, “general”, or absent PRO rationale and integrated interpretation of clinical and PRO results. A total of 11 (30%) and 6 (16%) combined papers reported “detailed” PRO rationale and integrated interpretation of results although only 2 (14%) and 1 (7%) primary papers achieved the same standard respectively. Supplemental papers provide better information with 11 (73%) and 3 (20%) achieving “detailed” rationale and integrated interpretation of results. Supplemental papers, however, were published a median of 20 months after the primary RCT data in lower impact factor journals (median 16.8 versus 5.2). Conclusion It is recommended that single

  6. Challenges in measuring outcomes for caregivers of people with mental health problems.

    PubMed

    Zendjidjian, Xavier Y; Boyer, Laurent

    2014-06-01

    Patient-reported outcomes (PROs) are increasingly important in health care and mental health research. Furthermore, caregivers become partners in care for patients with mental disorders, and health workers are more attentive to the expectations and needs of caregivers. A number of outcomes for caregivers are measured and used in daily practice in order to promote actions to improve health care systems and progress in research on the impact of mental disorders on their caregivers. This paper proposes an inventory of the different outcomes and different measurement tools used to assess the impact of disorders, raising a number of methodological and conceptual issues that limit the relevance of measurement tools and complicate their use. Finally, we propose some recommendations promoting the development of relevant outcome measures for caregivers and their integration into current systems of care.

  7. Electromyographic and patient-reported outcomes of a computer-guided occlusal adjustment performed on patients suffering from chronic myofascial pain

    PubMed Central

    Dib, Abraham; Sanchez, José-Miguel; López-Valverde, Antonio

    2015-01-01

    Objectives: Muscular hyperactivity is a potential source of symptoms in patients with temporal-mandibular disorders. An adequate occlusal adjustment may relieve such symptoms. This study aims to measure the effect of shortening the protrusive disclusion time (DT) and balancing the center of occlusal forces (COF) on the EMG recordings and assess the pain reported by chronic patients one month after the computer-guided occlusal adjustment. Study Design: The sample studied comprised 34 patients suffering from chronic facial pain in which the EMG activity of both masseters was recorded by electromyography. By selective grinding we alleviated all the occlusal interferences during the mandibular protrusion from the habitual closure position in order to establish an immediate posterior disclusion and an equilibration of the COF. Results: At follow-up 76.5% of the patients reported no facial pain. Moreover, the EMG activity and protrusive DT were significantly reduced, and occlusal and muscular function were significantly more symmetric than at baseline. Conclusions: According to this EMG study, this computer-guided occlusal adjustment is able to reduce the activity of the masseters and the self-reported muscular pain of patients one-month after treatment. Key words:Myofascial pain, occlusal adjustment, electromyography, T-Scan III, occlusal interferences. PMID:25475783

  8. Effect of complications within 90 days on patient-reported outcomes 3 months and 12 months following elective surgery for lumbar degenerative disease.

    PubMed

    Chotai, Silky; Parker, Scott L; Sivaganesan, Ahilan; Sielatycki, J Alex; Asher, Anthony L; McGirt, Matthew J; Devin, Clinton J

    2015-12-01

    OBJECT There is a paradigm shift toward rewarding providers for quality rather than volume. Complications appear to occur at a fairly consistent frequency in large aggregate data sets. Understanding how complications affect long-term patient-reported outcomes (PROs) following degenerative lumbar surgery is vital. The authors hypothesized that 90-day complications would adversely affect long-term PROs. METHODS Nine hundred six consecutive patients undergoing elective surgery for degenerative lumbar disease over a period of 4 years were enrolled into a prospective longitudinal registry. The following PROs were recorded at baseline and 12-month follow-up: Oswestry Disability Index (ODI) score, numeric rating scales for back and leg pain, quality of life (EQ-5D scores), general physical and mental health (SF-12 Physical Component Summary [PCS] and Mental Component Summary [MCS] scores) and responses to the North American Spine Society (NASS) satisfaction questionnaire. Previously published minimum clinically important difference (MCID) threshold were used to define meaningful improvement. Complications were divided into major (surgicalsite infection, hardware failure, new neurological deficit, pulmonary embolism, hematoma and myocardial infarction) and minor (urinary tract infection, pneumonia, and deep venous thrombosis). RESULTS Complications developed within 90 days of surgery in 13% (118) of the patients (major in 12% [108] and minor in 8% [68]). The mean improvement in ODI scores, EQ-5D scores, SF-12 PCS scores, and satisfaction at 3 months after surgery was significantly less in the patients with complications than in those who did not have major complications (ODI: 13.5 ± 21.2 vs 21.7 ± 19, < 0.0001; EQ-5D: 0.17 ± 0.25 vs 0.23 ± 0.23, p = 0.04; SF-12 PCS: 8.6 ± 13.3 vs 13.0 ± 11.9, 0.001; and satisfaction: 76% vs 90%, p = 0.002). At 12 months after surgery, the patients with major complications had higher ODI scores than those without complications (29.1

  9. Effect of complications within 90 days on patient-reported outcomes 3 months and 12 months following elective surgery for lumbar degenerative disease.

    PubMed

    Chotai, Silky; Parker, Scott L; Sivaganesan, Ahilan; Sielatycki, J Alex; Asher, Anthony L; McGirt, Matthew J; Devin, Clinton J

    2015-12-01

    OBJECT There is a paradigm shift toward rewarding providers for quality rather than volume. Complications appear to occur at a fairly consistent frequency in large aggregate data sets. Understanding how complications affect long-term patient-reported outcomes (PROs) following degenerative lumbar surgery is vital. The authors hypothesized that 90-day complications would adversely affect long-term PROs. METHODS Nine hundred six consecutive patients undergoing elective surgery for degenerative lumbar disease over a period of 4 years were enrolled into a prospective longitudinal registry. The following PROs were recorded at baseline and 12-month follow-up: Oswestry Disability Index (ODI) score, numeric rating scales for back and leg pain, quality of life (EQ-5D scores), general physical and mental health (SF-12 Physical Component Summary [PCS] and Mental Component Summary [MCS] scores) and responses to the North American Spine Society (NASS) satisfaction questionnaire. Previously published minimum clinically important difference (MCID) threshold were used to define meaningful improvement. Complications were divided into major (surgicalsite infection, hardware failure, new neurological deficit, pulmonary embolism, hematoma and myocardial infarction) and minor (urinary tract infection, pneumonia, and deep venous thrombosis). RESULTS Complications developed within 90 days of surgery in 13% (118) of the patients (major in 12% [108] and minor in 8% [68]). The mean improvement in ODI scores, EQ-5D scores, SF-12 PCS scores, and satisfaction at 3 months after surgery was significantly less in the patients with complications than in those who did not have major complications (ODI: 13.5 ± 21.2 vs 21.7 ± 19, < 0.0001; EQ-5D: 0.17 ± 0.25 vs 0.23 ± 0.23, p = 0.04; SF-12 PCS: 8.6 ± 13.3 vs 13.0 ± 11.9, 0.001; and satisfaction: 76% vs 90%, p = 0.002). At 12 months after surgery, the patients with major complications had higher ODI scores than those without complications (29.1

  10. Testing Multiple Outcomes in Repeated Measures Designs

    ERIC Educational Resources Information Center

    Lix, Lisa M.; Sajobi, Tolulope

    2010-01-01

    This study investigates procedures for controlling the familywise error rate (FWR) when testing hypotheses about multiple, correlated outcome variables in repeated measures (RM) designs. A content analysis of RM research articles published in 4 psychology journals revealed that 3 quarters of studies tested hypotheses about 2 or more outcome…

  11. General Outcome Measures for Verbal Operants

    ERIC Educational Resources Information Center

    Kubina, Richard M., Jr.; Wolfe, Pamela; Kostewicz, Douglas E.

    2009-01-01

    A general outcome measure (GOM) can be used to show progress towards a long-term goal. GOMs should sample domains of behavior across ages, be sensitive to change over time, be inexpensive and easy to use, and facilitate decision making. Skinner's (1957) analysis of verbal behavior may benefit from the development of GOM. To develop GOM, we…

  12. Patient Reported Outcome (PRO) assessment in epilepsy: a review of epilepsy-specific PROs according to the Food and Drug Administration (FDA) regulatory requirements

    PubMed Central

    2013-01-01

    Despite collection of patient reported outcome (PRO) data in clinical trials of antiepileptic drugs (AEDs), PRO results are not being routinely reported on European Medicines Agency (EMA) and Food and Drug Administration (FDA) product labels. This review aimed to evaluate epilepsy-specific PRO instruments against FDA regulatory standards for supporting label claims. Structured literature searches were conducted in Embase and Medline databases to identify epilepsy-specific PRO instruments. Only instruments that could potentially be impacted by pharmacological treatment, were completed by adults and had evidence of some validation work were selected for review. A total of 26 PROs were reviewed based on criteria developed from the FDA regulatory standards. The ability to meet these criteria was classified as either full, partial or no evidence, whereby partial reflected some evidence but not enough to comprehensively address the FDA regulatory standards. Most instruments provided partial evidence of content validity. Input from clinicians and literature was common although few involved patients in both item generation and cognitive debriefing. Construct validity was predominantly compromised by no evidence of a-priori hypotheses of expected relationships. Evidence for test-retest reliability and internal consistency was available for most PROs although few included complete results regarding all subscales and some failed to reach recommended thresholds. The ability to detect change and interpretation of change were not investigated in most instruments and no PROs had published evidence of a conceptual framework. The study concludes that none of the 26 have the full evidence required by the FDA to support a label claim, and all require further research to support their use as an endpoint. The Subjective Handicap of Epilepsy (SHE) and the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) have the fewest gaps that would need to be addressed through

  13. Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol

    PubMed Central

    Ahmed, Khaled; Kyte, Derek; Keeley, Thomas; Efficace, Fabio; Armes, Jo; Brown, Julia M; Calman, Lynn; Copland, Chris; Gavin, Anna; Glaser, Adam; Greenfield, Diana M; Lanceley, Anne; Taylor, Rachel; Velikova, Galina; Brundage, Michael; Mercieca-Bebber, Rebecca; King, Madeleine T

    2016-01-01

    Introduction Emerging evidence suggests that patient-reported outcome (PRO)-specific information may be omitted in trial protocols and that PRO results are poorly reported, limiting the use of PRO data to inform cancer care. This study aims to evaluate the standards of PRO-specific content in UK cancer trial protocols and their arising publications and to highlight examples of best-practice PRO protocol content and reporting where they occur. The objective of this study is to determine if these early findings are generalisable to UK cancer trials, and if so, how best we can bring about future improvements in clinical trials methodology to enhance the way PROs are assessed, managed and reported. Hypothesis: Trials in which the primary end point is based on a PRO will have more complete PRO protocol and publication components than trials in which PROs are secondary end points. Methods and analysis Completed National Institute for Health Research (NIHR) Portfolio Cancer clinical trials (all cancer specialities/age-groups) will be included if they contain a primary/secondary PRO end point. The NIHR portfolio includes cancer trials, supported by a range of funders, adjudged as high-quality clinical research studies. The sample will be drawn from studies completed between 31 December 2000 and 1 March 2014 (n=1141) to allow sufficient time for completion of the final trial report and publication. Two reviewers will then review the protocols and arising publications of included trials to: (1) determine the completeness of their PRO-specific protocol content; (2) determine the proportion and completeness of PRO reporting in UK Cancer trials and (3) model factors associated with PRO protocol and reporting completeness and with PRO reporting proportion. Ethics and dissemination The study was approved by the ethics committee at University of Birmingham (ERN_15-0311). Trial findings will be disseminated via presentations at local, national and international conferences, peer

  14. Patient Reported Outcome (PRO) assessment in epilepsy: a review of epilepsy-specific PROs according to the Food and Drug Administration (FDA) regulatory requirements.

    PubMed

    Nixon, Annabel; Kerr, Cicely; Breheny, Katie; Wild, Diane

    2013-03-11

    Despite collection of patient reported outcome (PRO) data in clinical trials of antiepileptic drugs (AEDs), PRO results are not being routinely reported on European Medicines Agency (EMA) and Food and Drug Administration (FDA) product labels. This review aimed to evaluate epilepsy-specific PRO instruments against FDA regulatory standards for supporting label claims. Structured literature searches were conducted in Embase and Medline databases to identify epilepsy-specific PRO instruments. Only instruments that could potentially be impacted by pharmacological treatment, were completed by adults and had evidence of some validation work were selected for review. A total of 26 PROs were reviewed based on criteria developed from the FDA regulatory standards. The ability to meet these criteria was classified as either full, partial or no evidence, whereby partial reflected some evidence but not enough to comprehensively address the FDA regulatory standards. Most instruments provided partial evidence of content validity. Input from clinicians and literature was common although few involved patients in both item generation and cognitive debriefing. Construct validity was predominantly compromised by no evidence of a-priori hypotheses of expected relationships. Evidence for test-retest reliability and internal consistency was available for most PROs although few included complete results regarding all subscales and some failed to reach recommended thresholds. The ability to detect change and interpretation of change were not investigated in most instruments and no PROs had published evidence of a conceptual framework. The study concludes that none of the 26 have the full evidence required by the FDA to support a label claim, and all require further research to support their use as an endpoint. The Subjective Handicap of Epilepsy (SHE) and the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) have the fewest gaps that would need to be addressed through

  15. Designing measurements to assess case management outcomes.

    PubMed

    Mateo, M A; Matzke, K; Newton, C

    1998-01-01

    Evaluating outcomes begins with determining the goals of case management. As the emphasis on the delivery of cost-effective patient care increases, comparing outcomes across settings is desirable and essential. A key component to comparing how an organization rates with similar institutions is to identify commonly used measures. Conducting a literature search, benchmarking, participating in initiatives of accrediting bodies, and establishing ways to collect and manage reliable and valid data are vital in laying the groundwork for an organization's ability to join evaluation projects across settings. PMID:9526390

  16. Designing measurements to assess case management outcomes.

    PubMed

    Mateo, Magdalena A; Matzke, Karen; Newton, Cheryl

    2002-01-01

    Evaluating outcomes begins with determining the goals of case management. As the emphasis on the delivery of cost-effective patient care increases, comparing outcomes across settings is desirable and essential. A key component to comparing how an organization rates with similar institutions is to identify commonly used measures. Conducting a literature search, benchmarking, participating in initiatives of accrediting bodies, and establishing ways to collect and manage reliable and valid data are vital in laying the groundwork for an organization's ability to join evaluation projects across settings. PMID:12478228

  17. An International Standard Set of Patient-Centered Outcome Measures After Stroke

    PubMed Central

    Salinas, Joel; Sprinkhuizen, Sara M.; Ackerson, Teri; Bernhardt, Julie; Davie, Charlie; George, Mary G.; Gething, Stephanie; Kelly, Adam G.; Lindsay, Patrice; Liu, Liping; Martins, Sheila C.O.; Morgan, Louise; Norrving, Bo; Ribbers, Gerard M.; Silver, Frank L.; Smith, Eric E.; Williams, Linda S.

    2016-01-01

    Background and Purpose— Value-based health care aims to bring together patients and health systems to maximize the ratio of quality over cost. To enable assessment of healthcare value in stroke management, an international standard set of patient-centered stroke outcome measures was defined for use in a variety of healthcare settings. Methods— A modified Delphi process was implemented with an international expert panel representing patients, advocates, and clinical specialists in stroke outcomes, stroke registers, global health, epidemiology, and rehabilitation to reach consensus on the preferred outcome measures, included populations, and baseline risk adjustment variables. Results— Patients presenting to a hospital with ischemic stroke or intracerebral hemorrhage were selected as the target population for these recommendations, with the inclusion of transient ischemic attacks optional. Outcome categories recommended for assessment were survival and disease control, acute complications, and patient-reported outcomes. Patient-reported outcomes proposed for assessment at 90 days were pain, mood, feeding, selfcare, mobility, communication, cognitive functioning, social participation, ability to return to usual activities, and health-related quality of life, with mobility, feeding, selfcare, and communication also collected at discharge. One instrument was able to collect most patient-reported subdomains (9/16, 56%). Minimum data collection for risk adjustment included patient demographics, premorbid functioning, stroke type and severity, vascular and systemic risk factors, and specific treatment/care-related factors. Conclusions— A consensus stroke measure Standard Set was developed as a simple, pragmatic method to increase the value of stroke care. The set should be validated in practice when used for monitoring and comparisons across different care settings. PMID:26604251

  18. Multi-institutional Prospective Evaluation of Bowel Quality of Life After Prostate External Beam Radiation Therapy Identifies Patient and Treatment Factors Associated With Patient-Reported Outcomes: The PROSTQA Experience

    SciTech Connect

    Hamstra, Daniel A.; Conlon, Anna S.C.; Daignault, Stephanie; Dunn, Rodney L.; Sandler, Howard M.; Hembroff, A. Larry; Zietman, Anthony L.; Kaplan, Irving; Ciezki, Jay; Kuban, Deborah A.; Wei, John T.; Sanda, Martin G.; Michalski, Jeff M.

    2013-07-01

    Purpose: To evaluate patients treated with external beam radiation therapy as part of the multicenter Prostate Cancer Outcomes and Satisfaction with Treatment Quality Assessment (PROSTQA), to identify factors associated with posttreatment patient-reported bowel health-related quality of life (HRQOL). Methods and Materials: Pretreatment characteristics and treatment details among 292 men were evaluated using a general linear mixed model for their association with measured HRQOL by the Expanded Prostate Cancer Index Composite instrument through 2 years after enrollment. Results: Bowel HRQOL had a median score of 100 (interquartile range 91.7-100) pretreatment and 95.8 (interquartile range 83.3-100) at 2 years, representing new moderate/big problems in 11% for urgency, 7% for frequency, 4% for bloody stools, and 8% for an overall bowel problems. Baseline bowel score was the strongest predictor for all 2-year endpoints. In multivariable models, a volume of rectum ≥25% treated to 70 Gy (V70) yielded a clinically significant 9.3-point lower bowel score (95% confidence interval [CI] 16.8-1.7, P=.015) and predicted increased risks for moderate to big fecal incontinence (P=.0008). No other radiation therapy treatment-related variables influenced moderate to big changes in rectal HRQOL. However, on multivariate analyses V70 ≥25% was associated with increases in small, moderate, or big problems with the following: incontinence (3.9-fold; 95% CI 1.1-13.4, P=.03), rectal bleeding (3.6-fold; 95% CI 1.3-10.2, P=.018), and bowel urgency (2.9-fold; 95% CI 1.1-7.6, P=.026). Aspirin use correlated with a clinically significant 4.7-point lower bowel summary score (95% CI 9.0-0.4, P=.03) and an increase in small, moderate, or big problems with bloody stools (2.8-fold; 95% CI 1.2-6.4, P=.018). Intensity modulated radiation therapy was associated with higher radiation therapy doses to the prostate and lower doses to the rectum but did not independently correlate with bowel HRQOL

  19. Toxicities affecting Quality of Life After Chemo-IMRT of Oropharyngeal Cancer: Prospective Study of Patient-Reported, Observer-Rated, and Objective Outcomes

    PubMed Central

    Hunter, Klaudia U; Schipper, Mathew; Feng, Felix Y; Lyden, Teresa; Haxer, Mark; Murdoch-Kinch, Carol-Anne; Cornwall, Benjamin; Lee, Connie SY; Chepeha, Douglas B; Eisbruch, Avraham

    2012-01-01

    Purpose After conventional radiotherapy for head and neck cancer, xerostomia has traditionally been the major effector of patient-reported quality of life (QOL), and recent publications suggest that dysphagia has an even stronger effect. We hypothesized that IMRT aiming to spare the salivary glands and swallowing structures reduced, or eliminated, the effects of these toxicities on QOL. Methods and Materials Prospective longitudinal study: 72 patients with Stage III-IV oropharyngeal cancer treated uniformly with definitive chemo-IMRT sparing the salivary glands and swallowing structures. Overall QOL was assessed by summary scores of the Head Neck QOL (HNQOL) and University of Washington QOL (UWQOL) questionnaires, as well as HNQOL “Overall Bother” question. QOL, observer-rated toxicities (CTCAE v2), and objective evaluations (videofluoroscopy assessing dysphagia and saliva flow rates assessing xerostomia) were recorded pre-therapy through 2 years post-therapy. Correlations between toxicities/objective evaluations and overall QOL were assessed using longitudinal repeated measures of analysis and Pearson correlations. Results All observer-rated toxicities and QOL scores worsened 1-3 months after therapy and improved through 12 months, with minor further improvements through 24 months. At 12 months, dysphagia grades 0-1, 2, and 3, were observed in 95%, 4%, and 1% of patients, respectively. Using all post-therapy observations, observer-rated dysphagia was highly correlated with all overall QOL measures (p<0.0001), while xerostomia, mucosal, and voice toxicities were significantly correlated with some, but not all, overall QOL measures, with lower correlation coefficients than dysphagia. Late overall QOL (≥6 or ≥12 months post-therapy) was primarily associated with observer-rated dysphagia, and to a lesser extent with xerostomia. Videofluoroscopy scores, but not salivary flows, were significantly correlated with some of the overall QOL measures. Conclusion After

  20. Recommended Patient-Reported Core Set of Symptoms to Measure in Head and Neck Cancer Treatment Trials

    PubMed Central

    Eisbruch, Avraham; Murphy, Barbara A.; Ridge, John A.; Gavin, Patrick; Reeve, Bryce B.; Bruner, Deborah Watkins; Movsas, Benjamin

    2014-01-01

    We identified a standard core set of patient-reported symptoms and health-related quality-of-life (HRQOL) domains to be assessed in head and neck (H&N) cancer clinical trials. The core symptom and HRQOL domain scores were used to guide recommendations by a working group of experts as part of a National Cancer Institute Symptom Management and HRQOL Clinical Trials Planning Meeting. A PubMed search was conducted using the search terms of “health-related quality of life” and “head & neck cancer,” limited to publications from January 1, 2000, to December 31, 2010. Fifty-four articles were used to guide the choice of recommendations. Twenty-nine symptoms and nine domains were identified, from which 12 H&N-specific core symptoms and HRQOL domains were recommended: swallowing, oral pain, skin changes, dry mouth, dental health, opening mouth/trismus, taste, excess/thick mucous/saliva, shoulder disability/motion, voice/hoarseness, social domain, and functional domain. This core set of 12 H&N-specific, patient-reported symptoms and HRQOL domains should be assessed in future H&N cancer clinical trials. PMID:25006189

  1. Recommended patient-reported core set of symptoms to measure in head and neck cancer treatment trials.

    PubMed

    Chera, Bhishamjit S; Eisbruch, Avraham; Murphy, Barbara A; Ridge, John A; Gavin, Patrick; Reeve, Bryce B; Bruner, Deborah Watkins; Movsas, Benjamin

    2014-07-01

    We identified a standard core set of patient-reported symptoms and health-related quality-of-life (HRQOL) domains to be assessed in head and neck (H&N) cancer clinical trials. The core symptom and HRQOL domain scores were used to guide recommendations by a working group of experts as part of a National Cancer Institute Symptom Management and HRQOL Clinical Trials Planning Meeting. A PubMed search was conducted using the search terms of "health-related quality of life" and "head & neck cancer," limited to publications from January 1, 2000, to December 31, 2010. Fifty-four articles were used to guide the choice of recommendations. Twenty-nine symptoms and nine domains were identified, from which 12 H&N-specific core symptoms and HRQOL domains were recommended: swallowing, oral pain, skin changes, dry mouth, dental health, opening mouth/trismus, taste, excess/thick mucous/saliva, shoulder disability/motion, voice/hoarseness, social domain, and functional domain. This core set of 12 H&N-specific, patient-reported symptoms and HRQOL domains should be assessed in future H&N cancer clinical trials. PMID:25006189

  2. Models for Measuring Growth and the Measurement of Outcomes.

    ERIC Educational Resources Information Center

    Athey, Irene

    The need for improved measures is particularly acute in reading because, in spite of the magnitude of time and effort which continues to be invested in reading, there is no insurance that the outcome is indeed proportionate to the effort involved. How much of the educational system's performance relative to its own goals is measured by a…

  3. Clinical outcome measures for Cutaneous Lupus Erythematosus

    PubMed Central

    Albrecht, Joerg; Werth, Victoria P.

    2011-01-01

    Cutaneous lupus erythematosus is a clinically heterogeneous group of rare skin diseases that only rarely have been subjected to controlled clinical trials. This may be have been partly due to a lack of suitable validated outcome instruments. Recently the FDA mandated that organ specific trials for lupus erythematosus need to use a combination of different outcome measures. The patient’s condition needs to be assessed in terms of quality of life, the patient’s global response and organ specific instruments that measure activity of the disease as well as damage due to the disease. For the skin the only formally validated and published instrument is currently the Cutaneous Lupus Erythematosis Disease Area and Severity Index (CLASI). This paper discusses the background of the development of the CLASI as well as issues related to its use and interpretation in the context of clinical research of CLE. PMID:20693208

  4. Psychological factors predict adherence to methotrexate in rheumatoid arthritis; findings from a systematic review of rates, predictors and associations with patient-reported and clinical outcomes

    PubMed Central

    Bluett, James; Barton, Anne; Hyrich, Kimme L; Cordingley, Lis; Verstappen, Suzanne M M

    2016-01-01

    Treatment response to methotrexate (MTX) for rheumatoid arthritis (RA) is not universal and non-adherence may partially explain this. The aims of this systematic review were to: (1) summarise existing rates of adherence to MTX, (2) identify predictors of adherence to MTX, and (3) assess the association between non-adherence and patient outcomes. The authors conducted a systematic search of papers published from January 1980 to February 2015 in PubMed, PsycINFO, EMBASE and CINAHL databases. Studies were eligible for inclusion if: (1) MTX was used as monotherapy or in combination with other therapies, (2) MTX was used in an RA or inflammatory polyarthritis population, (3) adherence was defined and measured as the extent to which patients followed their MTX regimen during the period of prescription, and (4) it was an original piece of research. In total, 10 studies met the inclusion criteria and 8 were evaluated as high quality. Rates of adherence ranged from 59% to 107%, and exposed differences in definitions of adherence, study methodologies and sample heterogeneity. A number of potential predictors of MTX adherence were identified; the strongest being related to beliefs in the necessity and efficacy of MTX, absence of low mood, mild disease and MTX monotherapy. Furthermore, 3 studies tested the association of adherence with disease activity as an outcome measure; all 3 found non-adherence associated with poor treatment response. This systematic review shows the importance of adherence to MTX treatment and summarises the associated modifiable factors. PMID:26848403

  5. Revisiting the Surveillance Epidemiology and End Results Cancer Registry and Medicare Health Outcomes Survey (SEER-MHOS) Linked Data Resource for Patient-Reported Outcomes Research in Older Adults with Cancer.

    PubMed

    Kent, Erin E; Malinoff, Rochelle; Rozjabek, Heather M; Ambs, Anita; Clauser, Steven B; Topor, Marie A; Yuan, Gigi; Burroughs, James; Rodgers, Anne B; DeMichele, Kimberly

    2016-01-01

    Researchers and clinicians are increasingly recognizing the value of patient-reported outcome (PRO) data to better characterize people's health and experiences with illness and care. Considering the rising prevalence of cancer in adults aged 65 and older, PRO data are particularly relevant for older adults with cancer, who often require complex cancer care and have additional comorbid conditions. A data linkage between the Surveillance Epidemiology and End Results (SEER) cancer registry and the Medicare Health Outcomes Survey (MHOS) was created through a partnership between the National Cancer Institute and the Centers for Medicare and Medicaid Services that created the opportunity to examine PROs in Medicare Advantage enrollees with and without cancer. The December 2013 linkage of SEER-MHOS data included the linked data for 12 cohorts, bringing the number of individuals in the linked data set to 95,723 with cancer and 1,510,127 without. This article reviews the features of the resource and provides information on some descriptive characteristics of the individuals in the data set (health-related quality of life, body mass index, fall risk management, number of unhealthy days in the past month). Individuals without (n=258,108) and with (n=3,440) cancer (1,311 men with prostate cancer, 982 women with breast cancer, 689 with colorectal cancer, 458 with lung cancer) were included in the current descriptive analysis. Given increasing longevity, advances in effective therapies and earlier detection, and population growth, the number of individuals aged 65 and older with cancer is expected to reach more than 12 million by 2020. SEER-MHOS provides population-level, self-reported, cancer registry-linked data for person-centered surveillance research on this growing population.

  6. Revisiting the Surveillance Epidemiology and End Results Cancer Registry and Medicare Health Outcomes Survey (SEER-MHOS) Linked Data Resource for Patient-Reported Outcomes Research in Older Adults with Cancer.

    PubMed

    Kent, Erin E; Malinoff, Rochelle; Rozjabek, Heather M; Ambs, Anita; Clauser, Steven B; Topor, Marie A; Yuan, Gigi; Burroughs, James; Rodgers, Anne B; DeMichele, Kimberly

    2016-01-01

    Researchers and clinicians are increasingly recognizing the value of patient-reported outcome (PRO) data to better characterize people's health and experiences with illness and care. Considering the rising prevalence of cancer in adults aged 65 and older, PRO data are particularly relevant for older adults with cancer, who often require complex cancer care and have additional comorbid conditions. A data linkage between the Surveillance Epidemiology and End Results (SEER) cancer registry and the Medicare Health Outcomes Survey (MHOS) was created through a partnership between the National Cancer Institute and the Centers for Medicare and Medicaid Services that created the opportunity to examine PROs in Medicare Advantage enrollees with and without cancer. The December 2013 linkage of SEER-MHOS data included the linked data for 12 cohorts, bringing the number of individuals in the linked data set to 95,723 with cancer and 1,510,127 without. This article reviews the features of the resource and provides information on some descriptive characteristics of the individuals in the data set (health-related quality of life, body mass index, fall risk management, number of unhealthy days in the past month). Individuals without (n=258,108) and with (n=3,440) cancer (1,311 men with prostate cancer, 982 women with breast cancer, 689 with colorectal cancer, 458 with lung cancer) were included in the current descriptive analysis. Given increasing longevity, advances in effective therapies and earlier detection, and population growth, the number of individuals aged 65 and older with cancer is expected to reach more than 12 million by 2020. SEER-MHOS provides population-level, self-reported, cancer registry-linked data for person-centered surveillance research on this growing population. PMID:26782871

  7. Understanding the outcomes measures used in Huntington disease pharmacologicaltrials: A systematic review

    PubMed Central

    Carlozzi, Noelle E; Miciura, Angela; Migliore, Nicholas; Dayalu, Praveen

    2014-01-01

    Background The identification of the gene mutation causing Huntington disease has raised hopes for new treatments to ease symptoms and slow functional decline. As such, there has been a push towards designing efficient pharmacological trials (i.e., drug trials), especially with regard to selecting outcomes measures that are both brief and sensitive to changes across the course of the disease, from subtle prodromal changes, to more severe end-stage changes. Objectives Recently, to aid in efficient development of new HD research studies, the National Institute of Neurological Disorders and Stroke (NINDS) published recommendations for measurement selection in HD. While these recommendations are helpful, many of the recommended measures have little published data in HD. As such, we conducted a systematic review of the literature to identify the most common outcomes measures used in HD clinical trials. Methods Major medical databases, including PubMed, Embase, CINAHL, and the Cochrane Central Register of Controlled Trials, were used to identify peer-reviewed journal articles in English from 2001 through April 2013; 151 pharmacological trials were identified. Results The majority of HD clinical trials employed clinician-reported outcomes measures (93%); patient reported outcome measures (11%) and observer reported outcome measures (3%) were used with much less frequency. Conclusions We provide a review of the most commonly used measures across these trials, compare these measures to the clinical recommendations made by the NINDS working groups, and provide recommendations for selecting measures for future clinical trials that meet the Food and Drug Administration standards. PMID:25300328

  8. Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1--eliciting concepts for a new PRO instrument.

    PubMed

    Patrick, Donald L; Burke, Laurie B; Gwaltney, Chad J; Leidy, Nancy Kline; Martin, Mona L; Molsen, Elizabeth; Ring, Lena

    2011-12-01

    The importance of content validity in developing patient reported outcomes (PRO) instruments is stressed by both the US Food and Drug Administration and the European Medicines Agency. Content validity is the extent to which an instrument measures the important aspects of concepts that developers or users purport it to assess. A PRO instrument measures the concepts most significant and relevant to a patient's condition and its treatment. For PRO instruments, items and domains as reflected in the scores of an instrument should be important to the target population and comprehensive with respect to patient concerns. Documentation of target population input in item generation, as well as evaluation of patient understanding through cognitive interviewing, can provide the evidence for content validity. Developing content for, and assessing respondent understanding of, newly developed PRO instruments for medical product evaluation will be discussed in this two-part ISPOR PRO Good Research Practices Task Force Report. Topics include the methods for generating items, documenting item development, coding of qualitative data from item generation, cognitive interviewing, and tracking item development through the various stages of research and preparing this tracking for submission to regulatory agencies. Part 1 covers elicitation of key concepts using qualitative focus groups and/or interviews to inform content and structure of a new PRO instrument. Part 2 covers the instrument development process, the assessment of patient understanding of the draft instrument using cognitive interviews and steps for instrument revision. The two parts are meant to be read together. They are intended to offer suggestions for good practices in planning, executing, and documenting qualitative studies that are used to support the content validity of PRO instruments to be used in medical product evaluation.

  9. Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: part 2--assessing respondent understanding.

    PubMed

    Patrick, Donald L; Burke, Laurie B; Gwaltney, Chad J; Leidy, Nancy Kline; Martin, Mona L; Molsen, Elizabeth; Ring, Lena

    2011-12-01

    The importance of content validity in developing patient reported outcomes (PRO) instruments is stressed by both the US Food and Drug Administration and the European Medicines Agency. Content validity is the extent to which an instrument measures the important aspects of concepts developers or users purport it to assess. A PRO instrument measures the concepts most relevant and important to a patient's condition and its treatment. For PRO instruments, items and domains as reflected in the scores of an instrument should be important to the target population and comprehensive with respect to patient concerns. Documentation of target population input in item generation, as well as evaluation of patient understanding through cognitive interviewing, can provide the evidence for content validity. Part 1 of this task force report covers elicitation of key concepts using qualitative focus groups and/or interviews to inform content and structure of a new PRO instrument. Building on qualitative interviews and focus groups used to elicit concepts, cognitive interviews help developers craft items that can be understood by respondents in the target population and can ultimately confirm that the final instrument is appropriate, comprehensive, and understandable in the target population. Part 2 details: 1) the methods for conducting cognitive interviews that address patient understanding of items, instructions, and response options; and 2) the methods for tracking item development through the various stages of research and preparing this tracking for submission to regulatory agencies. The task force report's two parts are meant to be read together. They are intended to offer suggestions for good practice in planning, executing, and documenting qualitative studies that are used to support the content validity of PRO instruments to be used in medical product evaluation.

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

    PubMed

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

    2015-02-01

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

  11. The primary outcome measure and its importance in clinical trials.

    PubMed

    Andrade, Chittaranjan

    2015-10-01

    The primary outcome measure is the outcome that an investigator considers to be the most important among the many outcomes that are to be examined in the study. The primary outcome needs to be defined at the time the study is designed. There are 2 reasons for this: it reduces the risk of false-positive errors resulting from the statistical testing of many outcomes, and it reduces the risk of a false-negative error by providing the basis for the estimation of the sample size necessary for an adequately powered study. This article discusses the setting of the primary outcome measure, the need for it, the increased risk of false-positive and false-negative errors in secondary outcome results, how to regard articles that do not state the primary outcome, how to interpret results when secondary outcomes are statistically significant but not the primary outcome, and limitations of the concept of a primary outcome measure in clinical trial research.

  12. Assessment of tinnitus: measurement of treatment outcomes.

    PubMed

    Meikle, M B; Stewart, B J; Griest, S E; Martin, W H; Henry, J A; Abrams, H B; McArdle, R; Newman, C W; Sandridge, S A

    2007-01-01

    There is a wide range of assessment techniques for tinnitus, but no consensus has developed concerning how best to measure either the presenting features of tinnitus or the effects of tinnitus treatments. Standardization of reliable and valid tinnitus measures would provide many advantages including improving the uniformity of diagnostic and screening criteria between clinics and facilitating comparison of treatment outcomes obtained at different sites. This chapter attempts to clarify issues involved in developing self-report questionnaires for the assessment of tinnitus. While the tinnitus questionnaires that are currently available provide valuable information on which to base diagnostic and screening decisions, they were not originally developed in such a way as to maximize their sensitivity to treatment-related changes in tinnitus. As a result, their construct validity for measuring treatment benefit has not received appropriate attention. In this paper, special emphasis is devoted to the use of effect sizes as an estimate of the ability of questionnaires (and their individual items) to measure changes associated with treatment. We discuss the criteria relevant to evaluating the effectiveness of a questionnaire for diagnostic purposes vs. for treatment-evaluation purposes, and we present a detailed illustration of how the various criteria have been applied in a recent questionnaire development effort. PMID:17956815

  13. Residual Effects of Sleep Medications Are Commonly Reported and Associated with Impaired Patient-Reported Outcomes among Insomnia Patients in the United States.

    PubMed

    Fitzgerald, Timothy; Vietri, Jeffrey

    2015-01-01

    Study Objective. To measure the association of symptoms attributed to residual effects of sleep medication (e.g., drowsiness, difficulty concentrating, and impaired memory) on self-reported functioning and satisfaction with these medications. Methods. Individuals using prescription medications for insomnia were invited to complete an Internet-based survey. Respondents were compared according to the presence of self-reported residual effects; relationships between severity of these effects and outcomes were modeled using regression. Measures included the Brief Insomnia Questionnaire, Work Productivity and Activity Impairment Questionnaire, and SATMED-Q. Subgroup analyses were conducted with patients aged ≥65 years. Approximately 80% reported experiencing ≥1 residual effect. The severity of residual effects was associated with increased residual effect-related work impairment, including absenteeism (RR = 1.46, p < 0.001), presenteeism (RR = 1.12, p < 0.001), overall work impairment (RR = 1.13, p < 0.001), and nonwork activity impairment (RR = 1.11, p < 0.001). More severe residual symptoms were also associated with increased difficulty in home management (Beta = .31, p < 0.001), ability to work (Beta = .31, p < 0.001), social relationships, (Beta = .32, p < 0.001), close personal relationships (Beta = .30, p < 0.001), and lower medication satisfaction (Beta = -.37, p < 0.001). Conclusions. Individuals using medications for insomnia commonly experience symptoms considered as residual effects, and these symptoms are associated with greater interference of sleep-related problems at work, at home, and with social relationships. PMID:26783470

  14. Patient-Reported Voice and Speech Outcomes After Whole-Neck Intensity Modulated Radiation Therapy and Chemotherapy for Oropharyngeal Cancer: Prospective Longitudinal Study

    SciTech Connect

    Vainshtein, Jeffrey M.; Griffith, Kent A.; Feng, Felix Y.; Vineberg, Karen A.; Chepeha, Douglas B.; Eisbruch, Avraham

    2014-08-01

    Purpose: To describe voice and speech quality changes and their predictors in patients with locally advanced oropharyngeal cancer treated on prospective clinical studies of organ-preserving chemotherapy–intensity modulated radiation therapy (chemo-IMRT). Methods and Materials: Ninety-one patients with stage III/IV oropharyngeal cancer were treated on 2 consecutive prospective studies of definitive chemoradiation using whole-field IMRT from 2003 to 2011. Patient-reported voice and speech quality were longitudinally assessed from before treatment through 24 months using the Communication Domain of the Head and Neck Quality of Life (HNQOL-C) instrument and the Speech question of the University of Washington Quality of Life (UWQOL-S) instrument, respectively. Factors associated with patient-reported voice quality worsening from baseline and speech impairment were assessed. Results: Voice quality decreased maximally at 1 month, with 68% and 41% of patients reporting worse HNQOL-C and UWQOL-S scores compared with before treatment, and improved thereafter, recovering to baseline by 12-18 months on average. In contrast, observer-rated larynx toxicity was rare (7% at 3 months; 5% at 6 months). Among patients with mean glottic larynx (GL) dose ≤20 Gy, >20-30 Gy, >30-40 Gy, >40-50 Gy, and >50 Gy, 10%, 32%, 25%, 30%, and 63%, respectively, reported worse voice quality at 12 months compared with before treatment (P=.011). Results for speech impairment were similar. Glottic larynx dose, N stage, neck dissection, oral cavity dose, and time since chemo-IMRT were univariately associated with either voice worsening or speech impairment. On multivariate analysis, mean GL dose remained independently predictive for both voice quality worsening (8.1%/Gy) and speech impairment (4.3%/Gy). Conclusions: Voice quality worsening and speech impairment after chemo-IMRT for locally advanced oropharyngeal cancer were frequently reported by patients, underrecognized by clinicians, and

  15. 42 CFR 410.146 - Diabetes outcome measurements.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 2 2012-10-01 2012-10-01 false Diabetes outcome measurements. 410.146 Section 410... MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Outpatient Diabetes Self-Management Training and Diabetes Outcome Measurements § 410.146 Diabetes outcome measurements. (a)...

  16. 42 CFR 410.146 - Diabetes outcome measurements.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 2 2011-10-01 2011-10-01 false Diabetes outcome measurements. 410.146 Section 410... MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Outpatient Diabetes Self-Management Training and Diabetes Outcome Measurements § 410.146 Diabetes outcome measurements. (a)...

  17. 42 CFR 410.146 - Diabetes outcome measurements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 2 2010-10-01 2010-10-01 false Diabetes outcome measurements. 410.146 Section 410... MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Outpatient Diabetes Self-Management Training and Diabetes Outcome Measurements § 410.146 Diabetes outcome measurements. (a)...

  18. 42 CFR 410.146 - Diabetes outcome measurements.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 2 2014-10-01 2014-10-01 false Diabetes outcome measurements. 410.146 Section 410... MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Outpatient Diabetes Self-Management Training and Diabetes Outcome Measurements § 410.146 Diabetes outcome measurements. (a)...

  19. 42 CFR 410.146 - Diabetes outcome measurements.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 2 2013-10-01 2013-10-01 false Diabetes outcome measurements. 410.146 Section 410... MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Outpatient Diabetes Self-Management Training and Diabetes Outcome Measurements § 410.146 Diabetes outcome measurements. (a)...

  20. Applying Outcome Measurements: A Guide to Educational Outcome Measurements and Their Uses. Seminar No. 5.

    ERIC Educational Resources Information Center

    Glaser, Ezra

    This guide is essentially designed as a teaching aid for those who would inform planners, officials of educational ministries, school administrators, principals, and teachers about educational outcome measurements. In outline and graphic form, the guide presents topics for discussion in a seminar dealing with the application of outcome…

  1. The Electronic Patient Reported Outcome Tool: Testing Usability and Feasibility of a Mobile App and Portal to Support Care for Patients With Complex Chronic Disease and Disability in Primary Care Settings

    PubMed Central

    Gill, Ashlinder; Khan, Anum Irfan; Hans, Parminder Kaur; Kuluski, Kerry; Cott, Cheryl

    2016-01-01

    Background People experiencing complex chronic disease and disability (CCDD) face some of the greatest challenges of any patient population. Primary care providers find it difficult to manage multiple discordant conditions and symptoms and often complex social challenges experienced by these patients. The electronic Patient Reported Outcome (ePRO) tool is designed to overcome some of these challenges by supporting goal-oriented primary care delivery. Using the tool, patients and providers collaboratively develop health care goals on a portal linked to a mobile device to help patients and providers track progress between visits. Objectives This study tested the usability and feasibility of adopting the ePRO tool into a single interdisciplinary primary health care practice in Toronto, Canada. The Fit between Individuals, Fask, and Technology (FITT) framework was used to guide our assessment and explore whether the ePRO tool is: (1) feasible for adoption in interdisciplinary primary health care practices and (2) usable from both the patient and provider perspectives. This usability pilot is part of a broader user-centered design development strategy. Methods A 4-week pilot study was conducted in which patients and providers used the ePRO tool to develop health-related goals, which patients then monitored using a mobile device. Patients and providers collaboratively set goals using the system during an initial visit and had at least 1 follow-up visit at the end of the pilot to discuss progress. Focus groups and interviews were conducted with patients and providers to capture usability and feasibility measures. Data from the ePRO system were extracted to provide information regarding tool usage. Results Six providers and 11 patients participated in the study; 3 patients dropped out mainly owing to health issues. The remaining 8 patients completed 210 monitoring protocols, equal to over 1300 questions, with patients often answering questions daily. Providers and patients

  2. Measuring patient outcomes in breast augmentation: introducing the BREAST-Q Augmentation module.

    PubMed

    Pusic, Andrea L; Reavey, Patrick L; Klassen, Anne F; Scott, Amie; McCarthy, Colleen; Cano, Stefan J

    2009-01-01

    The Breast-Q Augmentation module is a new and unique questionnaire for measuring patient-reported outcomes following breast augmentation. It has undergone a rigorous development and validation process and is currently the only questionnaire for breast augmentation that meets international and federal standards for questionnaire development. The Breast-Q Augmentation module covers a comprehensive set of concerns of breast augmentation patients, including satisfaction with breasts and impact on quality of life. With its excellent psychometric properties, the Breast-Q Augmentation module can provide clinicians and researchers with a wealth of essential data to improve the field of breast augmentation from the perspectives of both surgeons and patients.

  3. The Effects of as-Needed Nalmefene on Patient-Reported Outcomes and Quality of Life in Relation to a Reduction in Alcohol Consumption in Alcohol-Dependent Patients

    PubMed Central

    François, Clément; Rahhali, Nora; Chalem, Ylana; Sørensen, Per; Luquiens, Amandine; Aubin, Henri-Jean

    2015-01-01

    Background The objective of this article was to investigate the effect of as-needed nalmefene on health-related quality of life (HRQoL) in patients with alcohol dependence, and to relate changes in drinking behavior and status to HRQoL outcomes. Methods This post hoc analysis was conducted on a pooled subgroup of patients with at least a high drinking risk level (men: >60 g/day; women: >40 g/day) who participated in one of two randomized controlled 6-month studies, ESENSE 1 and ESENSE 2. Patients received nalmefene 18 mg or placebo on an as-needed basis, in addition to a motivational and adherence-enhancing intervention (BRENDA). At baseline and after 12 and 24 weeks questionnaires for the Medical Outcomes Study (MOS) 36-item Short-Form Health Survey (SF-36), European Quality of life-5 Dimensions (EQ-5D) and the Drinker Inventory of Consequences (DrInC-2R) were completed. Results The pooled population consisted of 667 patients (nalmefene: 335; placebo: 332), with no notable between-group differences in baseline patient demographics/characteristics. At week 24, nalmefene had a superior effect compared to placebo in improving SF-36 mental component summary scores (mean difference [95% CI], p-value: 3.09 [1.29, 4.89]; p=0.0008), SF-36 physical component summary scores (1.23 [0.15, 2.31]; p=0.026), EQ-5D utility index scores (0.03 [0.00, 0.06]; p=0.045), EQ-5D health state scores (3.46 [0.75, 6.17]; p=0.012), and DrInC-2R scores (-3.22 [-6.12, 0.33]; p=0.029). The improvements in SF-36 mental component summary scores at week 24, and the DrInC-2R total score change from baseline to week 24, were significantly correlated to reductions in heavy drinking days and total alcohol consumption at week 24. Conclusions As-needed nalmefene significantly improved almost all patient-reported HRQoL measures included in SF-36 and EQ-5D compared with placebo. These HRQoL gains were significantly correlated to reduced drinking behavior, as determined by reductions in heavy drinking days

  4. A promising method for identifying cross-cultural differences in patient perspective: the use of Internet-based focus groups for content validation of new Patient Reported Outcome assessments

    PubMed Central

    Atkinson, Mark J; Lohs, Jan; Kuhagen, Ilka; Kaufman, Julie; Bhaidani, Shamsu

    2006-01-01

    Objectives This proof of concept (POC) study was designed to evaluate the use of an Internet-based bulletin board technology to aid parallel cross-cultural development of thematic content for a new set of patient-reported outcome measures (PROs). Methods The POC study, conducted in Germany and the United States, utilized Internet Focus Groups (IFGs) to assure the validity of new PRO items across the two cultures – all items were designed to assess the impact of excess facial oil on individuals' lives. The on-line IFG activities were modeled after traditional face-to-face focus groups and organized by a common 'Topic' Guide designed with input from thought leaders in dermatology and health outcomes research. The two sets of IFGs were professionally moderated in the native language of each country. IFG moderators coded the thematic content of transcripts, and a frequency analysis of code endorsement was used to identify areas of content similarity and difference between the two countries. Based on this information, draft PRO items were designed and a majority (80%) of the original participants returned to rate the relative importance of the newly designed questions. Findings The use of parallel cross-cultural content analysis of IFG transcripts permitted identification of the major content themes in each country as well as exploration of the possible reasons for any observed differences between the countries. Results from coded frequency counts and transcript reviews informed the design and wording of the test questions for the future PRO instrument(s). Subsequent ratings of item importance also deepened our understanding of potential areas of cross-cultural difference, differences that would be explored over the course of future validation studies involving these PROs. Conclusion The use of IFGs for cross-cultural content development received positive reviews from participants and was found to be both cost and time effective. The novel thematic coding methodology

  5. Optimal outcome measures, research priorities, and international cooperation.

    PubMed

    Cox, R; Hyde, M; Gatehouse, S; Noble, W; Dillon, H; Bentler, R; Stephens, D; Arlinger, S; Beck, L; Wilkerson, D; Kramer, S; Kricos, P; Gagné, J P; Bess, F; Hallberg, L

    2000-08-01

    The participants in the Eriksholm Workshop on "Measuring Outcomes in Audiological Rehabilitation Using Hearing Aids" debated three issues that are reported in this article. First, it was agreed that the characteristics of an optimal outcome measure vary as a function of the purpose of the measurement. Potential characteristics of outcome self-report tools for four common goals of outcome measurement are briefly presented to illustrate this point. Second, 10 important research priorities in outcome measurement were identified and ranked. They are presented with brief discussion of the top five. Third, the concept of generating a brief universally applicable outcome measure was endorsed. This brief data set is intended to supplement existing outcome measures and to promote data combination and comparison across different social, cultural, and health-care delivery systems. A set of seven core items is proposed for further study.

  6. 42 CFR 486.318 - Condition: Outcome measures.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... SUPPLIERS Requirements for Certification and Designation and Conditions for Coverage: Organ Procurement Organizations Organ Procurement Organization Outcome Requirements § 486.318 Condition: Outcome measures. (a..., territories, or possessions, an OPO must meet all 3 of the following outcome measures: (1) The OPO's...

  7. Child Outcome Measures in the Study of Child Care Quality

    ERIC Educational Resources Information Center

    Zaslow, Martha; Halle, Tamara; Martin, Laurie; Cabrera, Natasha; Calkins, Julia; Pitzer, Lindsay; Margie, Nancy Geyelin

    2006-01-01

    This article assesses whether there are methodological problems with child outcome measures that may contribute to the small associations between child care quality and child outcomes found in the literature. Outcome measures used in 65 studies of child care quality published between 1979 and December 2005 were examined, taking the previous review…

  8. Efficacy and patient-reported outcomes with dose-intense temozolomide in patients with newly diagnosed pure and mixed anaplastic oligodendroglioma: a phase II multicenter study.

    PubMed

    Ahluwalia, Manmeet S; Xie, Hao; Dahiya, Saurabh; Hashemi-Sadraei, Nooshin; Schiff, David; Fisher, Paul G; Chamberlain, Marc C; Pannullo, Susan; Newton, Herbert B; Brewer, Cathy; Wood, Laura; Prayson, Richard; Elson, Paul; Peereboom, David M

    2015-03-01

    Standard initial therapy for patients with pure and mixed anaplastic oligodendrogliomas (AO/MAO) includes chemotherapy and radiation therapy. Anaplastic oligodendrogliomas with 1p/19q co-deletion are more responsive to chemotherapy. There is concern for potential long-term CNS toxicity of radiation. Hence an approach using chemotherapy initially and reserving radiation for progressive disease is attractive. This multicenter phase II trial included patients with newly diagnosed AO/MAO with central pathology review and 1p/19q assay. Temozolomide was given 150 mg/m(2) days 1-7 and 15-21, every 28 days for 8 cycles. The primary endpoint was progression free survival (PFS). Secondary endpoints included response rate, overall survival (OS), treatment toxicity and health-related quality of life (HRQL). Data from 62 patients enrolled between December 2001 and April 2007 at seven centers were analyzed. Among patients with measurable disease, 8 % achieved complete remission, 56 % had stable disease and 36 % had progression. The median PFS and OS were 27.2 months (95 % CI 11.9-36.3) and 105.8 months (95 % CI 51.5-N/A), respectively. Both 1p loss and 1p/19q co-deletion were positive prognostic factors for PFS (p < 0.001) and OS (p < 0.001); and there was some suggestion that 1p/19q co-deletion also predicted better response to chemotherapy (p = 0.007). Grade 3/4 toxicities were mainly hematological. Significantly improved HRQL in the future uncertainty domain of the brain cancer module was seen after cycle 4 (p < 0.001). This trial achieved outcomes similar to those reported previously. Toxicities from dose-intense temozolomide were manageable. Improvement in at least one HRQL domain increased over time. This trial supports the further study of first-line temozolomide monotherapy as an alternative to radiation therapy for patients with newly diagnosed AO/MAO with 1p 19q co-deleted tumors.

  9. Oncology Section EDGE Task Force on Prostate Cancer: A Systematic Review of Outcome Measures for Health-Related Quality of Life

    PubMed Central

    Harrington, Shana; Lee, Jeannette; Colon, Genevieve; Alappattu, Meryl

    2016-01-01

    Background Health-related quality of life (HRQOL) is multidimensional and subjective, encompassing occupational and physical function, psychological state, social interaction, and somatic sensation. Because of the wide scope of HRQOL and its implications for the medical management of prostate cancer survivors, clinicians and researchers need to know the most reliable and valid measures currently available for addressing this clinical construct in men diagnosed with prostate cancer. Purpose To identify and evaluate patient-reported outcome measures used to assess HRQOL in men diagnosed with prostate cancer and make recommendations for the use of these patient-reported outcome measures in both the research and clinic settings. Methods The literature was systematically reviewed for patient-reported outcome measures used in peer-reviewed, published research to assess HRQOL in men diagnosed with prostate cancer. The goals were to examine the psychometric properties of commonly used HRQOL measures in order to determine their clinical utility. Results The following patient-reported outcome measures are highly recommended by the Task Force to assess HRQOL in men diagnosed with prostate cancer: EORTC QLQ-P25 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire–Prostate 25), EPIC (Expanded Prostate Cancer Index Composite), FACT-P (Functional Assessment of Cancer Therapy–Prostate), UCLA-PCI (UCLA–Prostate Cancer Index), EORTC QLQ-C30 (EORTC Quality of Life Questionnaire–Cancer 30), FACT-G (Functional Assessment of Cancer Therapy–General), and SF (Short-Form) 36, 12, and 8. Conclusions A variety of patient-reported outcome measures have been reported in the literature to assess HRQOL in men diagnosed with prostate cancer. Seven measures were found to have satisfactory psychometric properties, as well as good clinical utility, and are recommended for use by the researchers on this Task Force. PMID:27134804

  10. Linked Patient-Reported Outcomes Data From Patients With Multiple Sclerosis Recruited on an Open Internet Platform to Health Care Claims Databases Identifies a Representative Population for Real-Life Data Analysis in Multiple Sclerosis

    PubMed Central

    Ghodge, Bhaskar; Bonzani, Ian C; Korn, Jonathan R; Medin, Jennie; Saraykar, Tanmay; Sengupta, Souvik; Saini, Deepanshu; Olson, Melvin

    2016-01-01

    Background An enormous amount of information relevant to public health is being generated directly by online communities. Objective To explore the feasibility of creating a dataset that links patient-reported outcomes data, from a Web-based survey of US patients with multiple sclerosis (MS) recruited on open Internet platforms, to health care utilization information from health care claims databases. The dataset was generated by linkage analysis to a broader MS population in the United States using both pharmacy and medical claims data sources. Methods US Facebook users with an interest in MS were alerted to a patient-reported survey by targeted advertisements. Eligibility criteria were diagnosis of MS by a specialist (primary progressive, relapsing-remitting, or secondary progressive), ≥12-month history of disease, age 18-65 years, and commercial health insurance. Participants completed a questionnaire including data on demographic and disease characteristics, current and earlier therapies, relapses, disability, health-related quality of life, and employment status and productivity. A unique anonymous profile was generated for each survey respondent. Each anonymous profile was linked to a number of medical and pharmacy claims datasets in the United States. Linkage rates were assessed and survey respondents’ representativeness was evaluated based on differences in the distribution of characteristics between the linked survey population and the general MS population in the claims databases. Results The advertisement was placed on 1,063,973 Facebook users’ pages generating 68,674 clicks, 3719 survey attempts, and 651 successfully completed surveys, of which 440 could be linked to any of the claims databases for 2014 or 2015 (67.6% linkage rate). Overall, no significant differences were found between patients who were linked and not linked for educational status, ethnicity, current or prior disease-modifying therapy (DMT) treatment, or presence of a relapse in

  11. Supporting Goal-Oriented Primary Health Care for Seniors with Complex Care Needs Using Mobile Technology: Evaluation and Implementation of the Health System Performance Research Network, Bridgepoint Electronic Patient Reported Outcome Tool

    PubMed Central

    Wodchis, Walter P; Upshur, Ross; Cott, Cheryl; McKinstry, Brian; Mercer, Stewart; Palen, Ted E; Ramsay, Tim; Thavorn, Kednapa

    2016-01-01

    Background Older adults experiencing multiple chronic illnesses are at high risk of hospitalization and health decline if they are unable to manage the significant challenges posed by their health conditions. Goal-oriented care approaches can provide better care for these complex patients, but clinicians find the process of ascertaining goals “too complex and too-time consuming,” and goals are often not agreed upon between complex patients and their providers. The electronic patient reported outcomes (ePRO) mobile app and portal offers an innovative approach to creating and monitoring goal-oriented patient-care plans to improve patient self-management and shared decision-making between patients and health care providers. The ePRO tool also supports proactive patient monitoring by the patient, caregiver(s), and health care provider. It was developed with and for older adults with complex care needs as a means to improve their quality of life. Objective Our proposed project will evaluate the use, effectiveness, and value for money of the ePRO tool in a 12-month multicenter, randomized controlled trial in Ontario; targeting individuals 65 or over with two or more chronic conditions that require frequent health care visits to manage their health conditions. Methods Intervention groups using the ePRO tool will be compared with control groups on measures of quality of life, patient experience, and cost-effectiveness. We will also evaluate the implementation of the tool. Results The proposed project presented in this paper will be funded through the Canadian Institute for Health Research (CIHR) eHealth Innovation Partnerships Program (eHIPP) program (CIHR–348362). The expected completion date of the study is November, 2019. Conclusions We anticipate our program of work will support improved quality of life and patient self-management, improved patient-centered primary care delivery, and will encourage the adoption of goal-oriented care approaches across primary

  12. Supporting Goal-Oriented Primary Health Care for Seniors with Complex Care Needs Using Mobile Technology: Evaluation and Implementation of the Health System Performance Research Network, Bridgepoint Electronic Patient Reported Outcome Tool

    PubMed Central

    Wodchis, Walter P; Upshur, Ross; Cott, Cheryl; McKinstry, Brian; Mercer, Stewart; Palen, Ted E; Ramsay, Tim; Thavorn, Kednapa

    2016-01-01

    Background Older adults experiencing multiple chronic illnesses are at high risk of hospitalization and health decline if they are unable to manage the significant challenges posed by their health conditions. Goal-oriented care approaches can provide better care for these complex patients, but clinicians find the process of ascertaining goals “too complex and too-time consuming,” and goals are often not agreed upon between complex patients and their providers. The electronic patient reported outcomes (ePRO) mobile app and portal offers an innovative approach to creating and monitoring goal-oriented patient-care plans to improve patient self-management and shared decision-making between patients and health care providers. The ePRO tool also supports proactive patient monitoring by the patient, caregiver(s), and health care provider. It was developed with and for older adults with complex care needs as a means to improve their quality of life. Objective Our proposed project will evaluate the use, effectiveness, and value for money of the ePRO tool in a 12-month multicenter, randomized controlled trial in Ontario; targeting individuals 65 or over with two or more chronic conditions that require frequent health care visits to manage their health conditions. Methods Intervention groups using the ePRO tool will be compared with control groups on measures of quality of life, patient experience, and cost-effectiveness. We will also evaluate the implementation of the tool. Results The proposed project presented in this paper will be funded through the Canadian Institute for Health Research (CIHR) eHealth Innovation Partnerships Program (eHIPP) program (CIHR–143559). The expected completion date of the study is November, 2019. Conclusions We anticipate our program of work will support improved quality of life and patient self-management, improved patient-centered primary care delivery, and will encourage the adoption of goal-oriented care approaches across primary

  13. Functional outcome measures for NF1-associated optic pathway glioma clinical trials

    PubMed Central

    Avery, Robert A.; Allen, Jeffrey C.; Ardern-Holmes, Simone L.; Bilaniuk, Larissa T.; Ferner, Rosalie E.; Gutmann, David H.; Listernick, Robert; Martin, Staci; Ullrich, Nicole J.; Liu, Grant T.

    2013-01-01

    Objective: The goal of the Response Evaluation in Neurofibromatosis and Schwannomatosis Visual Outcomes Committee is to define the best functional outcome measures for future neurofibromatosis type 1 (NF1)-associated optic pathway glioma (OPG) clinical trials. Methods: The committee considered the components of vision, other ophthalmologic parameters affected by OPG, potential biomarkers of visual function, and quality of life measures to arrive at consensus-based, evidence-driven recommendations for objective and measurable functional endpoints for OPG trials. Results: Visual acuity (VA) assessments using consistent quantitative testing methods are recommended as the main functional outcome measure for NF1-OPG clinical trials. Teller acuity cards are recommended for use as the primary VA endpoint, and HOTV as a secondary endpoint once subjects are old enough to complete it. The optic disc should be assessed for pallor, as this appears to be a contributory variable that may affect the interpretation of VA change over time. Given the importance of capturing patient-reported outcomes in clinical trials, evaluating visual quality of life using the Children's Visual Function Questionnaire as a secondary endpoint is also proposed. Conclusions: The use of these key functional endpoints will be essential for evaluating the efficacy of future OPG clinical trials. PMID:24249802

  14. Comparative Effectiveness of Sphincter-Sparing Surgery versus Abdominoperineal Resection in Rectal Cancer: Patient-Reported Outcomes in National Surgical Adjuvant Breast and Bowel Project Randomized Trial R-04

    PubMed Central

    Russell, Marcia M.; Ganz, Patricia A.; Lopa, Samia; Yothers, Greg; Ko, Clifford Y.; Arora, Amit; Atkins, James N.; Bahary, Nathan; Soori, Gamini; Robertson, John M.; Eakle, Janice; Marchello, Benjamin T.; Wozniak, Timothy F.; Beart, Robert W.; Wolmark, Norman

    2015-01-01

    Objective NSABP R-04 was a randomized controlled trial of neoadjuvant chemoradiotherapy in patients with resectable stage II–III rectal cancer. We hypothesized that patients who underwent abdominoperineal resection (APR) would have a poorer quality of life than those who underwent sphincter-sparing surgery (SSS). Methods To obtain patient-reported outcomes (PROs) we administered two symptom scales at baseline and 1 year postoperatively: the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) and the European Organization for the Research and Treatment of Cancer module for patients with Colorectal Cancer Quality of Life Questionnaire (EORTC QLQ-CR38). Scoring was stratified by non-randomly assigned definitive surgery (APR vs SSS). Analyses controlled for baseline scores and stratification factors: age, gender, stage, intended surgery, and randomly assigned chemoradiotherapy. Results Of 1,608 randomly assigned patients, 987 had data for planned analyses; 62% underwent SSS; 38% underwent APR. FACT-C total and subscale scores were not statistically different by surgery at one year. For the EORTC-QLQ-CR38 functional scales, APR patients reported worse body image (70.3 vs 77.0, P=0.0005) at one year than did SSS patients. Males undergoing APR reported worse sexual enjoyment (43.7 vs 54.7, P=0.02) at one year than did those undergoing SSS. For the EORTC-QLQ-CR38 symptom scale scores, APR patients reported worse micturition symptoms than the SSS group at one year (26.9 vs 21.5, P=0.03). SSS patients reported worse GI tract symptoms than did the APR patients (18.9 vs 15.2, P<0.0001), as well as weight loss (10.1 vs 6.0, P=0.002). Conclusions Symptoms and functional problems were detected at one year by EORTC-QLQ-CR38, reflecting different symptom profiles in patients who underwent APR than those who underwent SSS. Information from these PROs may be useful in counseling patients anticipating surgery for rectal cancer. PMID:24670844

  15. A Review of Outcome Measures in Early Childhood Programs

    ERIC Educational Resources Information Center

    Mannan, Hasheem; Summers, Jean Ann; Turnbull, Ann P.; Poston, Denise J.

    2006-01-01

    The authors undertook a review of measures available for assessing outcomes of early childhood services for children with disabilities and their families. With principles of family-centered practice mandating the inclusion of both family and child outcome measures in effective evaluation plans, the review examined measures with established…

  16. Comparison of Patient-Reported Outcome from Neck-Preserving, Short-Stem Arthroplasty and Resurfacing Arthroplasty in Younger Osteoarthritis Patients

    PubMed Central

    Dettmer, Marius; Pourmoghaddam, Amir; Kreuzer, Stefan W.

    2015-01-01

    Hip resurfacing has been considered a good treatment option for younger, active osteoarthritis patients. However, there are several identified issues concerning risk for neck fractures and issues related to current metal-on-metal implant designs. Neck-preserving short-stem implants have been discussed as a potential alternative, but it is yet unclear which method is better suited for younger adults. We compared hip disability and osteoarthritis outcome scores (HOOS) from a young group of patients (n = 52, age 48.9 ± 6.1 years) who had received hip resurfacing (HR) with a cohort of patients (n = 73, age 48.2 ± 6.6 years) who had received neck-preserving, short-stem implant total hip arthroplasty (THA). Additionally, durations for both types of surgery were compared. HOOS improved significantly preoperatively to last followup (>1 year) in both groups (p < 0.0001, η2 = 0.69); there were no group effects or interactions. Surgery duration was significantly longer for resurfacing (104.4 min ± 17.8) than MiniHip surgery (62.5 min ± 14.8), U = 85.0, p < 0.0001, η2 = 0.56. The neck-preserving short-stem approach may be preferable to resurfacing due to the less challenging surgery, similar outcome, and controversy regarding resurfacing implant designs. PMID:26101669

  17. Health Outcome after Major Trauma: What Are We Measuring?

    PubMed Central

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

    2014-01-01

    Importance Trauma is a global disease and is among the leading causes of disability in the world. The importance of outcome beyond trauma survival has been recognised over the last decade. Despite this there is no internationally agreed approach for assessment of health outcome and rehabilitation of trauma patients. Objective To systematically examine to what extent outcomes measures evaluate health outcomes in patients with major trauma. Data Sources MEDLINE, EMBASE, and CINAHL (from 2006–2012) were searched for studies evaluating health outcome after traumatic injuries. Study selection and data extraction Studies of adult patients with injuries involving at least two body areas or organ systems were included. Information on study design, outcome measures used, sample size and outcomes were extracted. The World Health Organisation International Classification of Function, Disability and Health (ICF) were used to evaluate to what extent outcome measures captured health impacts. Results 34 studies from 755 studies were included in the review. 38 outcome measures were identified. 21 outcome measures were used only once and only five were used in three or more studies. Only 6% of all possible health impacts were captured. Concepts related to activity and participation were the most represented but still only captured 12% of all possible concepts in this domain. Measures performed very poorly in capturing concepts related to body function (5%), functional activities (11%) and environmental factors (2%). Conclusion Outcome measures used in major trauma capture only a small proportion of health impacts. There is no inclusive classification for measuring disability or health outcome following trauma. The ICF may provide a useful framework for the development of a comprehensive health outcome measure for trauma care. PMID:25051353

  18. Can We Convert Between Outcome Measures of Disability for Chronic Low Back Pain?

    PubMed Central

    Morris, Tom; Stallard, Nigel; Underwood, Martin; Patel, Shilpa

    2015-01-01

    Study Design. Retrospective database analysis. Objective. A range of patient-reported outcomes were used to measure disability due to low back pain. There is not a single back pain disability measurement commonly used in all randomized controlled trials. We report here our assessment as to whether different disability measures are sufficiently comparable to allow data pooling across trials. Summary of Background Data. We used individual patient data from a repository of data from back pain trials of therapist-delivered interventions. Methods. We used data from 11 trials (n = 6089 patients) that had at least 2 of the following 7 measurements: Roland-Morris Disability Questionnaire, Chronic Pain Grade disability score, Physical Component Summary of the 12- or 36-Item Short Form Health Survey, Patient Specific Functional Scale, Pain Disability Index, Oswestry Disability Index, and Hannover Functional Ability Questionnaire. Within each trial, the change score between baseline and short-term follow-up was computed for each outcome and this was used to calculate the correlation between the change scores and the Cohen's κ for the 3-level outcome of change score of less than, equal to, and more than zero. It was considered feasible to pool 2 measures if they were at least moderately correlated (correlation >0.5) and have at least moderately similar responsiveness (κ > 0.4). Results. Although all pairs of measures were found to be positively correlated, most correlations were less than 0.5, with only 1 pair of outcomes in 1 trial having a correlation of more than 0.6. All κ statistics were less than 0.4 so that in no cases were the criteria for acceptability of pooling measures satisfied. Conclusion. The lack of agreement between different outcome measures means that pooling of data on these different disability measurements in a meta-analysis is not recommended. Level of Evidence: 2 PMID:25955090

  19. Hypofractionated radiotherapy versus conventionally fractionated radiotherapy for patients with intermediate-risk localised prostate cancer: 2-year patient-reported outcomes of the randomised, non-inferiority, phase 3 CHHiP trial

    PubMed Central

    Wilkins, Anna; Mossop, Helen; Syndikus, Isabel; Khoo, Vincent; Bloomfield, David; Parker, Chris; Logue, John; Scrase, Christopher; Patterson, Helen; Birtle, Alison; Staffurth, John; Malik, Zafar; Panades, Miguel; Eswar, Chinnamani; Graham, John; Russell, Martin; Kirkbride, Peter; O'Sullivan, Joe M; Gao, Annie; Cruickshank, Clare; Griffin, Clare; Dearnaley, David; Hall, Emma

    2015-01-01

    , number ISRCTN97182923. Findings 2100 participants in the CHHiP trial consented to be included in the QoL substudy: 696 assigned to the 74 Gy schedule, 698 assigned to the 60 Gy schedule, and 706 assigned to the 57 Gy schedule. Of these individuals, 1659 (79%) provided data pre-radiotherapy and 1444 (69%) provided data at 24 months after radiotherapy. Median follow-up was 50·0 months (IQR 38·4–64·2) on April 9, 2014, which was the most recent follow-up measurement of all data collected before the QoL data were analysed in September, 2014. Comparison of 74 Gy in 37 fractions, 60 Gy in 20 fractions, and 57 Gy in 19 fractions groups at 2 years showed no overall bowel bother in 269 (66%), 266 (65%), and 282 (65%) men; very small bother in 92 (22%), 91 (22%), and 93 (21%) men; small bother in 26 (6%), 28 (7%), and 38 (9%) men; moderate bother in 19 (5%), 23 (6%), and 21 (5%) men, and severe bother in four (<1%), three (<1%) and three (<1%) men respectively (74 Gy vs 60 Gy, ptrend=0.64, 74 Gy vs 57 Gy, ptrend=0·59). We saw no differences between treatment groups in change of bowel bother score from baseline or pre-radiotherapy to 24 months. Interpretation The incidence of patient-reported bowel symptoms was low and similar between patients in the 74 Gy control group and the hypofractionated groups up to 24 months after radiotherapy. If efficacy outcomes from CHHiP show non-inferiority for hypofractionated treatments, these findings will add to the growing evidence for moderately hypofractionated radiotherapy schedules becoming the standard treatment for localised prostate cancer. Funding Cancer Research UK, Department of Health, and the National Institute for Health Research Cancer Research Network. PMID:26522334

  20. Effect of Gaboxadol on Patient-reported Measures of Sleep and Waking Function in Patients with Primary Insomnia: Results from Two Randomized, Controlled, 3-month Studies

    PubMed Central

    Roth, Thomas; Lines, Christopher; Vandormael, Kristel; Ceesay, Paulette; Anderson, Donald; Snavely, Duane

    2010-01-01

    Objective: To evaluate the efficacy and safety of gaboxadol in the treatment of Primary Insomnia. Methods: Two studies were performed in patients 18 to 65 years of age with Primary Insomnia. After a 7-day single-blind placebo run-in, patients were randomized to double-blind treatment with gaboxadol 15 mg (N = 310), 10 mg (N = 308), or placebo (N = 309) over 3 months in Study 1; and gaboxadol 15 mg (N = 304) or placebo (N = 301) over 12 months in Study 2. Treatment was administered at bedtime. The primary efficacy endpoints in each study were change from baseline in patient-reported total sleep time (sTST) and time to sleep onset (sTSO) at month 3. Safety was assessed primarily by adverse event reports. Results: In Study 1, gaboxadol 15 mg significantly improved sTST (difference vs. placebo of 20.4 min, p < 0.01) and sTSO (difference vs. placebo of −9.8 min, p < 0.05) at 3 months, while gaboxadol 10 mg had no significant effects on these measures. In Study 2, gaboxadol 15 mg showed numerical superiority for improvements on sTST (difference vs. placebo of 14.5 min) and sTSO (difference vs. placebo of −4.9 min) at 3 months, but these differences were not significant. In both studies, there was evidence that the efficacy of gaboxadol was more pronounced in women than men. Gaboxadol was generally well tolerated over 3 months in Study 1, and over 12 months in Study 2. Conclusion: Gaboxadol 15 mg showed variable efficacy on measures of sleep duration and onset at 3 months in adult patients with Primary Insomnia in these studies and appeared to be more effective in women than men. Gaboxadol 10 mg was not effective in these studies. (Clinical trial registration numbers: NCT00103818, NCT00095069) Citation: Roth T; Lines C; Vandormael K; Ceesay P; Anderson D; Snavely D. Effect of gaboxadol on patient-reported measures of sleep and waking function in patients with Primary Insomnia: results from two randomized, controlled, 3-month studies. J Clin Sleep Med 2010

  1. Measuring Program Outcomes: Using Retrospective Pretest Methodology.

    ERIC Educational Resources Information Center

    Pratt, Clara C.; McGuigan, William M.; Katsev, Aphra R.

    2000-01-01

    Used longitudinal data from 307 mothers of firstborn infants participating in a home-visitation, child abuse prevention program in a retrospective pretest methodology. Results shows that when response shift bias was present, the retrospective pretest methodology produced a more legitimate assessment of program outcomes than did the traditional…

  2. Sensitivity of Outcome Measures for Treatments of Generalized Social Phobia.

    ERIC Educational Resources Information Center

    Taylor, Steven; Woody, Sheila; McLean, Peter D.; Koch, William J.

    1997-01-01

    The sensitivity of five measures of outcomes of treatment for generalized social phobia was studied with 60 people diagnosed with generalized social phobia. Outcome measures were completed before and after treatment and three months later, and effect sizes were computed. Results support the usefulness of the Social Phobia and Anxiety Inventory (S.…

  3. Learning Outcomes across Disciplines and Professions: Measurement and Interpretation

    ERIC Educational Resources Information Center

    Caspersen, Joakim; Frølich, Nicoline; Karlsen, Hilde; Aamodt, Per Olaf

    2014-01-01

    Learning outcomes of higher education are a quality tool in a changing higher education landscape but cannot be seen as neutral measures across professions and disciplines. Survey results from graduates and recent graduates indicate that prevailing measures of learning outcomes yield the same result within and across disciplinary and professional…

  4. Clinically Meaningful Differences in Patient-Reported Outcomes With Amifostine in Combination With Chemoradiation for Locally Advanced Non-Small-Cell Lung Cancer: An Analysis of RTOG 9801

    SciTech Connect

    Sarna, Linda Swann, Suzanne; Langer, Corey; Werner-Wasik, Maria; Nicolaou, Nicos; Komaki, Ritsuko; Machtay, Mitchell; Byhardt, Roger; Wasserman, Todd; Movsas, Benjamin

    2008-12-01

    Purpose: The purpose of this study is to analyze changes in quality of life (QOL) and symptoms from pretreatment to 6 weeks posttreatment in a Phase III randomized study (Radiation Therapy Oncology Group 9801) of amifostine (AM) vs. no AM in patients with Stages II-III non-small-cell lung cancer receiving paclitaxel and carboplatin as induction and then concurrently with hyperfractionated radiation therapy (RT). Methods and Materials: One hundred thirty-eight patients with baseline and 6-week posttreatment QOL data were analyzed. There were no significant differences in baseline demographics between those who did and did not have QOL data. The QOL and symptoms were assessed by using the European Organization for Research and Treatment of Cancer (EORTC) Global QOL and Pain subscales and the EORTC-Lung Cancer-13 symptom tool. Clinically relevant changes in QOL were characterized by 10-point differences in individual scores pre/post treatment. A daily diary of patient-rated difficulty swallowing and a weekly physician-rated dysphagia log (using National Cancer Institute Common Toxicity Criteria) were completed during treatment. Weight loss was monitored. Differences in outcomes were examined according to smoking status, alcohol use, and sex. Results: Patients receiving AM reported significantly greater pain reduction after chemoradiation (34% vs. no AM, 21%), less difficulty swallowing during chemoradiation, and less weight loss than patients not receiving AM. However, physician-rated assessments of dysphagia were not significantly different by treatment arm. There were no other significant changes in QOL or symptoms according to treatment arm, smoking status, alcohol use, or sex. Conclusions: Patient evaluations of difficulty swallowing and pain suggest benefits from AM use that are distinct from clinician-rated assessments.

  5. The impact of hypoglycaemia on quality of life and related patient-reported outcomes in Type 2 diabetes: a narrative review.

    PubMed

    Barendse, S; Singh, H; Frier, B M; Speight, J

    2012-03-01

    As a common side effect of insulin treatment for diabetes, hypoglycaemia is a constant threat and can have far-reaching and potentially devastating consequences, including immediate physical injury as well as more pervasive cognitive, behavioural and emotional effects. Moreover, as a significant limiting factor in achieving optimal glycaemic control, exposure to hypoglycaemia can influence diabetes self-management. Although hypoglycaemia is known to occur in Type 2 diabetes, its morbidity and impact on the individual are not well recognized. The aim of the current review is to examine published evidence to achieve a synthesis of the scope and significance of the potential detriment caused by hypoglycaemia to individuals with Type 2 diabetes. The implications of these observations for treatment and research have also been considered. A narrative review was performed of empirical papers published in English since 1966, reporting the effect of hypoglycaemia on quality of life and related outcomes (including generic and diabetes-specific quality of life, emotional well-being and health utilities) in Type 2 diabetes. Research demonstrates the potential impact of hypoglycaemia on the lives of people with Type 2 diabetes, from an association with depressive symptoms and heightened anxiety, to impairment of the ability to drive, work and function in ways that are important for quality of life. Few studies consider hypoglycaemia as an explanatory variable in combination with quality of life or related primary endpoints. As a consequence, there is a pressing need for high-quality research into the overall impact of hypoglycaemia on the lives of people with Type 2 diabetes.

  6. Toxicities Affecting Quality of Life After Chemo-IMRT of Oropharyngeal Cancer: Prospective Study of Patient-Reported, Observer-Rated, and Objective Outcomes

    SciTech Connect

    Hunter, Klaudia U.; Schipper, Matthew; Feng, Felix Y.; Lyden, Teresa; Haxer, Mark; Murdoch-Kinch, Carol-Anne; Cornwall, Benjamin; Lee, Connie S.Y.; Chepeha, Douglas B.; Eisbruch, Avraham

    2013-03-15

    Purpose: To test the hypothesis that intensity modulated radiation therapy (IMRT) aiming to spare the salivary glands and swallowing structures would reduce or eliminate the effects of xerostomia and dysphagia on quality of life (QOL). Methods and Materials: In this prospective, longitudinal study, 72 patients with stage III-IV oropharyngeal cancer were treated uniformly with definitive chemo-IMRT sparing the salivary glands and swallowing structures. Overall QOL was assessed by summary scores of the Head Neck QOL (HNQOL) and University of Washington QOL (UWQOL) questionnaires, as well as the HNQOL “Overall Bother” question. Quality of life, observer-rated toxicities (Common Toxicity Criteria Adverse Effects scale, version 2), and objective evaluations (videofluoroscopy assessing dysphagia and saliva flow rates assessing xerostomia) were recorded from before therapy through 2 years after therapy. Correlations between toxicities/objective evaluations and overall QOL were assessed using longitudinal repeated measures of analysis and Pearson correlations. Results: All observer-rated toxicities and QOL scores worsened 1-3 months after therapy and improved through 12 months, with minor further improvements through 24 months. At 12 months, dysphagia grades 0-1, 2, and 3, were observed in 95%, 4%, and 1% of patients, respectively. Using all posttherapy observations, observer-rated dysphagia was highly correlated with all overall QOL measures (P<.0001), whereas xerostomia and mucosal and voice toxicities were significantly correlated with some, but not all, overall QOL measures, with lower correlation coefficients than dysphagia. Late overall QOL (≥6 or ≥12 months after therapy) was primarily associated with observer-rated dysphagia, and to a lesser extent with xerostomia. Videofluoroscopy scores, but not salivary flows, were significantly correlated with some of the overall QOL measures. Conclusion: After chemo-IMRT, although late dysphagia was on average mild

  7. Patient-reported outcomes in primary care patients with COPD: psychometric properties and usefulness of the Clinical COPD Questionnaire (CCQ). A cross-sectional study

    PubMed Central

    Pommer, Antoinette M; Pouwer, François; Denollet, Johan; Meijer, Jan-Willem; Pop, Victor J

    2014-01-01

    Background: Chronic obstructive pulmonary disease (COPD) is a common disease with considerable consequences for patients’ daily lives. The Clinical COPD Questionnaire (CCQ) was designed to measure these consequences in daily practice. Although the CCQ is widely used, its original structure has never been tested. Aims: This study examines the psychometric properties of the CCQ with regard to its latent structure in a sample of primary care patients with COPD. Methods: Two cross-sectional studies were conducted; in study 1 (N=243) exploratory analyses, including exploratory factor analysis (EFA) and Mokken scale analysis, were performed to explore the latent structure of the CCQ. In study 2 (N=244), confirmatory factor analysis (CFA) was conducted to evaluate the model fit of the structure found in study 1. Results: Both EFA and Mokken scale analysis revealed a structure of two dimensions (‘general impact’ α=0.91 and ‘cough’ α=0.84). This structure, however, was not confirmed in study 2, nor was the original structure. However, subsequently removing items that violated the assumption of a normal response distribution did result in an excellent model fit with two dimensions measuring ‘dyspnoea’ and ‘cough’ (CFA: comparative fit index (CFI) 0.98; normed fit index (NFI) 0.97; root mean squared error of approximation (RMSEA) 0.08 (0.04)). Conclusions: In primary care, factor analyses on the CCQ revealed a two-component structure measuring ‘general impact’, and ‘cough’. A shortened and more specific version of the CCQ could be regarded as a useful instrument to screen for exacerbations by measuring dyspnoea, coughing and producing phlegm. PMID:25030777

  8. Correlations between outcomes of random measurements

    NASA Astrophysics Data System (ADS)

    Tran, Minh Cong; Dakić, Borivoje; Laskowski, Wiesław; Paterek, Tomasz

    2016-10-01

    We recently showed that multipartite correlations between outcomes of random observables detect quantum entanglement in all pure and some mixed states. In this followup article we further develop this approach, derive a maximal amount of such correlations, and show that they are not monotonous under local operations and classical communication. Nevertheless, we demonstrate their usefulness in entanglement detection with a single random observable per party. Finally we study convex-roof extension of the correlations and provide a closed-form necessary and sufficient condition for entanglement in rank-2 mixed states and a witness in general.

  9. Generating Outcome Measurements: Economic and Societal. A Guide to Educational Outcomes Measurements and Their Uses. Seminar No. 4.

    ERIC Educational Resources Information Center

    Mushkin, Selma J.; Billings, Bradley B.

    This guide is essentially designed as a teaching aid for those who would inform planners, officials of educational ministires, school administrators, principals, and teachers about educational outcome measurements. In outline and graphic form, the guide presents topics for discussion in a seminar dealing with generating outcome measurements:…

  10. Collagenase clostridium histolyticum in patients with Dupuytren’s contracture: results from POINT X, an open-label study of clinical and patient-reported outcomes

    PubMed Central

    Arner, M.; Pajardi, G.; Reichert, B.; Szabo, Z.; Masmejean, E. H.; Fores, J.; Chapman, D. S.; Gerber, R. A.; Huard, F.; Seghouani, A.; Szczypa, P. P.

    2015-01-01

    In POINT X, a study designed to reflect clinical practice and patient treatment choices, 254 European patients received open-label collagenase for Dupuytren’s contracture. The most severely affected joint was treated first in 74% of patients. In total, 52%, 41%, 7%, and 1% of patients selected the little, ring, middle, and index finger, respectively; 79% had one or two joints treated. Only 9% of patients (n = 24) received 4 or 5 injections. The mean improvement in total passive extension deficit (TPED) was 34° on day 1, improving further by day 7 to 42°. This secondary improvement was maintained by day 90 and month 6. The mean number of injections/joint was 1.2 for the metacarpophalangeal joint and 1.25 for the proximal interphalangeal joint. Median time to recovery was 4 days; the mean improvement in hand function was clinically relevant as measured by the Unité Rhumatologique des Affections de la Main (URAM) score. In total, 87% and 86% of patients and physicians, respectively, were very satisfied or satisfied with treatment at month 6, although correlation between TPED and patient satisfaction was weak (Spearman −0.18, 95% CI −0.32 to −0.06). Collagenase was well tolerated, with 10 (3.9%) patients experiencing severe adverse events. As a real-world study, the POINT X findings can be generalized to the at-large population. PMID:24470559

  11. Collagenase clostridium histolyticum in patients with Dupuytren's contracture: results from POINT X, an open-label study of clinical and patient-reported outcomes.

    PubMed

    Warwick, D; Arner, M; Pajardi, G; Reichert, B; Szabo, Z; Masmejean, E H; Fores, J; Chapman, D S; Gerber, R A; Huard, F; Seghouani, A; Szczypa, P P

    2015-02-01

    In POINT X, a study designed to reflect clinical practice and patient treatment choices, 254 European patients received open-label collagenase for Dupuytren's contracture. The most severely affected joint was treated first in 74% of patients. In total, 52%, 41%, 7%, and 1% of patients selected the little, ring, middle, and index finger, respectively; 79% had one or two joints treated. Only 9% of patients (n = 24) received 4 or 5 injections. The mean improvement in total passive extension deficit (TPED) was 34° on day 1, improving further by day 7 to 42°. This secondary improvement was maintained by day 90 and month 6. The mean number of injections/joint was 1.2 for the metacarpophalangeal joint and 1.25 for the proximal interphalangeal joint. Median time to recovery was 4 days; the mean improvement in hand function was clinically relevant as measured by the Unité Rhumatologique des Affections de la Main (URAM) score. In total, 87% and 86% of patients and physicians, respectively, were very satisfied or satisfied with treatment at month 6, although correlation between TPED and patient satisfaction was weak (Spearman -0.18, 95% CI -0.32 to -0.06). Collagenase was well tolerated, with 10 (3.9%) patients experiencing severe adverse events. As a real-world study, the POINT X findings can be generalized to the at-large population.

  12. High Level of Agreement between Electronic and Paper Mode of Administration of a Thyroid-Specific Patient-Reported Outcome, ThyPRO

    PubMed Central

    Rasmussen, Sofie Larsen; Rejnmark, Lars; Ebbehøj, Eva; Feldt-Rasmussen, Ulla; Rasmussen, Åse Krogh; Bjorner, Jakob Bue; Watt, Torquil

    2016-01-01

    Introduction and Purpose Use of electronic questionnaires to collect health-related quality-of-life data has evolved as an alternative to paper questionnaires. For the electronic questionnaire to be used interchangeably with the validated paper questionnaire, measurement properties similar to the original must be demonstrated. The aim of the present study was to assess the equivalence between the paper version and the electronic version of the thyroid-related quality-of-life questionnaire ThyPRO. Methods Patients with Graves' hyperthyroidism or autoimmune hypothyroidism in a clinically stable phase were included. The patients were recruited from two endocrine outpatient centers. All patients completed both versions in a randomized test-retest set-up. Scores were compared using intraclass correlation coefficients (ICCs), paired t tests and Bland-Altman plots. Limits of agreement were compared with data from a previous paper-paper test-retest study. Results 104 patients were included. ICCs were generally high for the 13 scales, ranging from 0.76 to 0.95. There was a small but significant difference in the scale score between paper and electronic administration for the Cosmetic complaints scale, but no differences were found for any other scale. Bland-Altman plots showed similar limits of agreement compared to the earlier test-retest study of the paper version of ThyPRO. Conclusion Based on our analyses using ICCs, paired t tests and Bland-Altman plots, we found adequate agreement between the paper and electronic questionnaires. The statistically significant difference in score found in the Cosmetic complaints scale is small and probably clinically insignificant. PMID:27099841

  13. Outcome Measures in Quality of Life.

    PubMed

    Tate, D G; Dijkers, M; Johnson-Greene, L

    1996-01-01

    The concept of quality of life (QOL) represents a new paradigm in rehabilitation research and cSinical care. Three measurement approaches have been used to investigate QOL of individuals: (1) evaluative or subjective, (2) objective, and (3) quality adjusted life year (QALY). QALYs represent the utility approach to measurement with emphasis on value of, desirability of, or preference for conditions or status. When the condition in question isdefined as health, health-related quality of life (HQOL) measures are employed. Very few studies are found in the literature addressing QOL of stroke patients. Among studies reviewed, HQOL measures are often used. A summary of these studies and discussion of limitations associated with QOL measures utilized are provided. PMID:27620148

  14. Measuring Assistive Technology Outcomes in Schools Using Functional Assessment.

    ERIC Educational Resources Information Center

    Silverman, Michelle Kaye; Stratman, Kristine Freiberg; Smith, Roger O.

    2000-01-01

    Activities of Project OATS (Outcomes of Assistive Technology in the Schools) are described, including identification and piloting of existing assessment instruments for use as an outcome measure, examining the validity of the School Function Assessment, and field testing the School Function Assessment-Assistive Technology Version, an adaptation of…

  15. 42 CFR 486.318 - Condition: Outcome measures.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... SUPPLIERS Requirements for Certification and Designation and Conditions for Coverage: Organ Procurement Organizations Organ Procurement Organization Outcome Requirements § 486.318 Condition: Outcome measures. (a... donation rate of eligible donors as a percentage of eligible deaths is no more than 1.5 standard...

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

    NASA Astrophysics Data System (ADS)

    Baek, J.

    2013-12-01

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

  17. Survey and online discussion groups to develop a patient-rated outcome measure on acceptability of treatment response in vitiligo

    PubMed Central

    2014-01-01

    Background Vitiligo is a chronic depigmenting skin disorder which affects around 0.5-1% of the world’s population. The outcome measures used most commonly in trials to judge treatment success focus on repigmentation. Patient-reported outcome measures of treatment success are rarely used, although recommendations have been made for their inclusion in vitiligo trials. This study aimed to evaluate the face validity of a new patient-reported outcome measure of treatment response, for use in future trials and clinical practice. Method An online survey to gather initial views on what constitutes treatment success for people with vitiligo or their parents/carers, followed by online discussion groups with patients to reach consensus on what constitutes treatment success for individuals with vitiligo, and how this can be assessed in the context of trials. Participants were recruited from an existing database of vitiligo patients and through posts on the social network sites Facebook and Twitter. Results A total of 202 survey responses were received, of which 37 were excluded and 165 analysed. Three main themes emerged as important in assessing treatment response: a) the match between vitiligo and normal skin (how well it blends in); b) how noticeable the vitiligo is and c) a reduction in the size of the white patches. The majority of respondents said they would consider 80% or more repigmentation to be a worthwhile treatment response after 9 months of treatment. Three online discussion groups involving 12 participants led to consensus that treatment success is best measured by asking patients how noticeable their vitiligo is after treatment. This was judged to be best answered using a 5-point Likert scale, on which a score of 4 or 5 represents treatment success. Conclusions This study represents the first step in developing a patient reported measure of treatment success in vitiligo trials. Further work is now needed to assess its construct validity and responsiveness to

  18. Validation of electronic systems to collect patient-reported outcome (PRO) data-recommendations for clinical trial teams: report of the ISPOR ePRO systems validation good research practices task force.

    PubMed

    Zbrozek, Arthur; Hebert, Joy; Gogates, Gregory; Thorell, Rod; Dell, Christopher; Molsen, Elizabeth; Craig, Gretchen; Grice, Kenneth; Kern, Scottie; Hines, Sheldon

    2013-06-01

    Outcomes research literature has many examples of high-quality, reliable patient-reported outcome (PRO) data entered directly by electronic means, ePRO, compared to data entered from original results on paper. Clinical trial managers are increasingly using ePRO data collection for PRO-based end points. Regulatory review dictates the rules to follow with ePRO data collection for medical label claims. A critical component for regulatory compliance is evidence of the validation of these electronic data collection systems. Validation of electronic systems is a process versus a focused activity that finishes at a single point in time. Eight steps need to be described and undertaken to qualify the validation of the data collection software in its target environment: requirements definition, design, coding, testing, tracing, user acceptance testing, installation and configuration, and decommissioning. These elements are consistent with recent regulatory guidance for systems validation. This report was written to explain how the validation process works for sponsors, trial teams, and other users of electronic data collection devices responsible for verifying the quality of the data entered into relational databases from such devices. It is a guide on the requirements and documentation needed from a data collection systems provider to demonstrate systems validation. It is a practical source of information for study teams to ensure that ePRO providers are using system validation and implementation processes that will ensure the systems and services: operate reliably when in practical use; produce accurate and complete data and data files; support management control and comply with any existing regulations. Furthermore, this short report will increase user understanding of the requirements for a technology review leading to more informed and balanced recommendations or decisions on electronic data collection methods. PMID:23796281

  19. Validation of electronic systems to collect patient-reported outcome (PRO) data-recommendations for clinical trial teams: report of the ISPOR ePRO systems validation good research practices task force.

    PubMed

    Zbrozek, Arthur; Hebert, Joy; Gogates, Gregory; Thorell, Rod; Dell, Christopher; Molsen, Elizabeth; Craig, Gretchen; Grice, Kenneth; Kern, Scottie; Hines, Sheldon

    2013-06-01

    Outcomes research literature has many examples of high-quality, reliable patient-reported outcome (PRO) data entered directly by electronic means, ePRO, compared to data entered from original results on paper. Clinical trial managers are increasingly using ePRO data collection for PRO-based end points. Regulatory review dictates the rules to follow with ePRO data collection for medical label claims. A critical component for regulatory compliance is evidence of the validation of these electronic data collection systems. Validation of electronic systems is a process versus a focused activity that finishes at a single point in time. Eight steps need to be described and undertaken to qualify the validation of the data collection software in its target environment: requirements definition, design, coding, testing, tracing, user acceptance testing, installation and configuration, and decommissioning. These elements are consistent with recent regulatory guidance for systems validation. This report was written to explain how the validation process works for sponsors, trial teams, and other users of electronic data collection devices responsible for verifying the quality of the data entered into relational databases from such devices. It is a guide on the requirements and documentation needed from a data collection systems provider to demonstrate systems validation. It is a practical source of information for study teams to ensure that ePRO providers are using system validation and implementation processes that will ensure the systems and services: operate reliably when in practical use; produce accurate and complete data and data files; support management control and comply with any existing regulations. Furthermore, this short report will increase user understanding of the requirements for a technology review leading to more informed and balanced recommendations or decisions on electronic data collection methods.

  20. Measuring outcomes in plastic surgery: body image and quality of life in abdominoplasty patients.

    PubMed

    Bolton, Michael A; Pruzinsky, Thomas; Cash, Thomas F; Persing, John A

    2003-08-01

    Abdominoplasty is an increasingly common aesthetic surgery procedure that has yet to be evaluated using the most recently developed and psychometrically sophisticated measures of body image and quality-of-life outcomes. This study prospectively evaluated 30 consecutive female abdominoplasty patients, preoperatively and postoperatively, using measures of body image, psychological investment in appearance, and general psychosocial functioning. One-way repeated-measures (pretest versus posttest) analyses of variance revealed significant positive postsurgical changes on the Appearance Evaluation subscale of the Multidimensional Body-Self Relations Questionnaire. Mean scores for the questionnaire's Body Areas Satisfaction Scale improved postoperatively (p < 0.001). Scores for the Body Exposure and Sexual Relations Questionnaire also improved significantly (p < 0.001) postoperatively. These findings indicate significant improvements in body image outcome, including positive changes in patients' evaluations of their overall appearance, their average body image dissatisfaction, and their experiences of self-consciousness and avoidance of body exposure during sexual activities. As predicted, no changes were seen on any measure of psychological investment in appearance or on patients' reports of general psychosocial functioning (self-esteem, satisfaction with life, or social anxiety). PMID:12900625

  1. Report from the fourth international consensus meeting to harmonize core outcome measures for atopic eczema/dermatitis clinical trials (HOME initiative).

    PubMed

    Chalmers, J R; Simpson, E; Apfelbacher, C J; Thomas, K S; von Kobyletzki, L; Schmitt, J; Singh, J A; Svensson, Å; Williams, H C; Abuabara, K; Aoki, V; Ardeleanu, M; Awici-Rasmussen, M; Barbarot, S; Berents, T L; Block, J; Bragg, A; Burton, T; Bjerring Clemmensen, K K; Creswell-Melville, A; Dinesen, M; Drucker, A; Eckert, L; Flohr, C; Garg, M; Gerbens, L A A; Graff, A L B; Hanifin, J; Heinl, D; Humphreys, R; Ishii, H A; Kataoka, Y; Leshem, Y A; Marquort, B; Massuel, M-A; Merhand, S; Mizutani, H; Murota, H; Murrell, D F; Nakahara, T; Nasr, I; Nograles, K; Ohya, Y; Osterloh, I; Pander, J; Prinsen, C; Purkins, L; Ridd, M; Sach, T; Schuttelaar, M-L A; Shindo, S; Smirnova, J; Sulzer, A; Synnøve Gjerde, E; Takaoka, R; Vestby Talmo, H; Tauber, M; Torchet, F; Volke, A; Wahlgren, C-F; Weidinger, S; Weisshaar, E; Wollenberg, A; Yamaga, K; Zhao, C Y; Spuls, P I

    2016-07-01

    This article is a report of the fourth meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in Malmö, Sweden on 23-24 April 2015 (HOME IV). The aim of the meeting was to achieve consensus over the preferred outcome instruments for measuring patient-reported symptoms and quality of life for the HOME core outcome set for atopic eczema (AE). Following presentations, which included data from systematic reviews, consensus discussions were held in a mixture of whole group and small group discussions. Small groups were allocated a priori to ensure representation of different stakeholders and countries. Decisions were voted on using electronic keypads. For the patient-reported symptoms, the group agreed by vote that itch, sleep loss, dryness, redness/inflamed skin and irritated skin were all considered essential aspects of AE symptoms. Many instruments for capturing patient-reported symptoms were discussed [including the Patient-Oriented SCOring Atopic Dermatitis index, Patient-Oriented Eczema Measure (POEM), Self-Administered Eczema Area and Severity Index, Itch Severity Scale, Atopic Dermatitis Quickscore and the Nottingham Eczema Severity Score] and, by consensus, POEM was selected as the preferred instrument to measure patient-reported symptoms. Further work is needed to determine the reliability and measurement error of POEM. Further work is also required to establish the importance of pain/soreness and the importance of collecting information regarding the intensity of symptoms in addition to their frequency. Much of the discussion on quality of life concerned the Dermatology Life Quality Index and Quality of Life Index for Atopic Dermatitis; however, consensus on a preferred instrument for measuring this domain could not be reached. In summary, POEM is recommended as the HOME core outcome instrument for measuring AE symptoms. PMID:27436240

  2. Outcome Measures for Artificial Pancreas Clinical Trials: A Consensus Report.

    PubMed

    Maahs, David M; Buckingham, Bruce A; Castle, Jessica R; Cinar, Ali; Damiano, Edward R; Dassau, Eyal; DeVries, J Hans; Doyle, Francis J; Griffen, Steven C; Haidar, Ahmad; Heinemann, Lutz; Hovorka, Roman; Jones, Timothy W; Kollman, Craig; Kovatchev, Boris; Levy, Brian L; Nimri, Revital; O'Neal, David N; Philip, Moshe; Renard, Eric; Russell, Steven J; Weinzimer, Stuart A; Zisser, Howard; Lum, John W

    2016-07-01

    Research on and commercial development of the artificial pancreas (AP) continue to progress rapidly, and the AP promises to become a part of clinical care. In this report, members of the JDRF Artificial Pancreas Project Consortium in collaboration with the wider AP community 1) advocate for the use of continuous glucose monitoring glucose metrics as outcome measures in AP trials, in addition to HbA1c, and 2) identify a short set of basic, easily interpreted outcome measures to be reported in AP studies whenever feasible. Consensus on a broader range of measures remains challenging; therefore, reporting of additional metrics is encouraged as appropriate for individual AP studies or study groups. Greater consistency in reporting of basic outcome measures may facilitate the interpretation of study results by investigators, regulatory bodies, health care providers, payers, and patients themselves, thereby accelerating the widespread adoption of AP technology to improve the lives of people with type 1 diabetes. PMID:27330126

  3. Can a future choice affect a past measurement's outcome?

    NASA Astrophysics Data System (ADS)

    Aharonov, Yakir; Cohen, Eliahu; Elitzur, Avshalom C.

    2015-04-01

    An EPR experiment is studied where each particle within the entangled pair undergoes a few weak measurements (WMs) along some pre-set spin orientations, with the outcomes individually recorded. Then the particle undergoes one strong measurement along an orientation chosen at the last moment. Bell-inequality violation is expected between the two final measurements within each EPR pair. At the same time, statistical agreement is expected between these strong measurements and the earlier weak ones performed on that pair. A contradiction seemingly ensues: (i) Bell's theorem forbids spin values to exist prior to the choice of the orientation measured; (ii) A weak measurement is not supposed to determine the outcome of a successive strong one; and indeed (iii) Almost no disentanglement is inflicted by the WMs; and yet (iv) The outcomes of weak measurements statistically agree with those of the strong ones, suggesting the existence of pre-determined values, in contradiction with (i). Although the conflict can be solved by mere mitigation of the above restrictions, the most reasonable resolution seems to be that of the Two-State-Vector Formalism (TSVF), namely, that the choice of the experimenter has been encrypted within the weak measurement's outcomes, even before the experimenters themselves know what their choice will be.

  4. Dietary changes and dietary supplement use, and underlying motives for these habits reported by colorectal cancer survivors of the Patient Reported Outcomes Following Initial Treatment and Long-Term Evaluation of Survivorship (PROFILES) registry.

    PubMed

    Bours, Martijn J; Beijer, Sandra; Winkels, Renate M; van Duijnhoven, Fränzel J; Mols, Floortje; Breedveld-Peters, José J; Kampman, Ellen; Weijenberg, Matty P; van de Poll-Franse, Lonneke V

    2015-07-01

    In the present study, we aimed to describe dietary changes made post-diagnosis and current dietary supplement use by survivors of colorectal cancer (CRC), and explore the underlying motives for these lifestyle habits. Cross-sectional analyses were performed for 1458 stage I-IV CRC survivors of the Patient Reported Outcomes Following Initial Treatment and Long-Term Evaluation of Survivorship (PROFILES) registry, diagnosed between 2000 and 2009. Lifestyle, sociodemographic and clinical information was collected. Prevalence of and motivations for dietary changes and supplement use were assessed. Associations between lifestyle, sociodemographic and clinical variables were analysed by multivariable logistic regression. CRC survivors (57% male) were on average 70 (SD 9) years of age and diagnosed 7 (SD 3) years ago. Dietary changes post-diagnosis were reported by 36% of the survivors and current supplement use by 32%. Motivations for dietary changes were mostly cancer-related (44% reported 'prevention of cancer recurrence' as the main reason), while motivations for supplement use were less frequently related to the cancer experience (38% reported 'to improve health and prevent disease in general' as the main reason). Dietary changes were significantly associated with dietary supplement use (OR 1.5, 95% CI 1.1, 2.1). Survivors who had received dietary advice, were non-smokers, under 65 years of age, and had no stoma were more likely to have changed their diet. Survivors who were female, had multiple co-morbidities, and no overweight or obesity were more likely to use supplements. In conclusion, many CRC survivors alter their diet post-diagnosis and use dietary supplements, in part for different reasons. Insights into motivations behind these lifestyle habits and characteristics of CRC survivors adopting these habits can improve the tailoring of lifestyle counselling strategies.

  5. Are validated outcome measures used in distal radial fractures truly valid?

    PubMed Central

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

    2016-01-01

    Objectives Patient-reported outcome measures (PROMs) are often used to evaluate the outcome of treatment in patients with distal radial fractures. Which PROM to select is often based on assessment of measurement properties, such as validity and reliability. Measurement properties are assessed in clinimetric studies, and results are often reviewed without considering the methodological quality of these studies. Our aim was to systematically review the methodological quality of clinimetric studies that evaluated measurement properties of PROMs used in patients with distal radial fractures, and to make recommendations for the selection of PROMs based on the level of evidence of each individual measurement property. Methods A systematic literature search was performed in PubMed, EMbase, CINAHL and PsycINFO databases to identify relevant clinimetric studies. Two reviewers independently assessed the methodological quality of the studies on measurement properties, using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Level of evidence (strong / moderate / limited / lacking) for each measurement property per PROM was determined by combining the methodological quality and the results of the different clinimetric studies. Results In all, 19 out of 1508 identified unique studies were included, in which 12 PROMs were rated. The Patient-rated wrist evaluation (PRWE) and the Disabilities of Arm, Shoulder and Hand questionnaire (DASH) were evaluated on most measurement properties. The evidence for the PRWE is moderate that its reliability, validity (content and hypothesis testing), and responsiveness are good. The evidence is limited that its internal consistency and cross-cultural validity are good, and its measurement error is acceptable. There is no evidence for its structural and criterion validity. The evidence for the DASH is moderate that its responsiveness is good. The evidence is limited that its reliability and the

  6. Deconstructing race and ethnicity: implications for measurement of health outcomes.

    PubMed

    Manly, Jennifer J

    2006-11-01

    A crucial issue for health researchers is how to measure health and health-related behaviors across racial/ethnic groups. This commentary outlines an approach that involves the deconstruction of race/ethnicity, which clarifies the independent influences of acculturation, quality of education, socioeconomic class, and racial socialization on outcomes of interest. Research on the influence of these variables on health outcomes in general, and cognitive test performance specifically, is presented. This research indicates that when variables such as quality of education, wealth, and perceived racism are taken into account, the effect of race/ethnicity on health outcomes is greatly reduced. In other words, race/ethnicity serves as a proxy for these more meaningful variables, and explicit measurement of these constructs will improve research of health within majority and minority ethnic groups.

  7. A clinically meaningful theory of outcome measures in rehabilitation medicine.

    PubMed

    Massof, Robert W

    2010-01-01

    Comparative effectiveness research in rehabilitation medicine requires the development and validation of clinically meaningful and scientifically rigorous measurements of patient states and theories that explain and predict outcomes of intervention. Patient traits are latent (unobservable) variables that can be measured only by inference from observations of surrogate manifest (observable) variables. In the behavioral sciences, latent variables are analogous to intensive physical variables such as temperature and manifest variables are analogous to extensive physical variables such as distance. Although only one variable at a time can be measured, the variable can have a multidimensional structure that must be understood in order to explain disagreements among different measures of the same variable. The use of Rasch theory to measure latent trait variables can be illustrated with a balance scale metaphor that has randomly added variability in the weights of the objects being measured. Knowledge of the distribution of the randomly added variability provides the theoretical structure for estimating measures from ordinal observation scores (e.g., performance measures or rating scales) using statistical inference. In rehabilitation medicine, the latent variable of primary interest is the patient's functional ability. Functional ability can be estimated from observations of surrogate performance measures (e.g., speed and accuracy) or self-report of the difficulty the patient experiences performing specific activities. A theoretical framework borrowed from project management, called the Activity Breakdown Structure (ABS), guides the choice of activities for assessment, based on the patient's value judgments, to make the observations clinically meaningful. In the case of low vision, the functional ability measure estimated from Rasch analysis of activity difficulty ratings was discovered to be a two-dimensional variable. The two visual function dimensions are independent

  8. Conceptualizing Outcome and Impact Measures for Intelligence Services

    ERIC Educational Resources Information Center

    Gainor, Rhiannon; Bouthillier, France

    2014-01-01

    Introduction: The purpose of this qualitative, exploratory study is to clarify ambiguous concepts in intelligence services literature specifically related to measurement of intelligence outcomes and impact. Method: Face to face interviews were held with five subject experts from various intelligence fields and countries regarding their…

  9. Measuring Student Learning Outcomes Using the SALG Instrument

    ERIC Educational Resources Information Center

    Scholl, Kathleen; Olsen, Heather M.

    2014-01-01

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

  10. The Children's Performance Outcome Measures: Results after Six Months.

    ERIC Educational Resources Information Center

    Massey, Tom; Kershaw, Mary Ann; Armstrong, Mary; Shepard, Jennifer; Wir, Liang

    This report describes the implementation and first 6 months of data collection of the required performance outcome measures for children receiving mental health services in Florida, as required under Florida's 1994 Government Performance and Accountability Act. This summary is of data received from August 1996 to January 1997 and includes data for…

  11. Use of Outcome Measurement by Paediatric AHPs in Northern Ireland

    ERIC Educational Resources Information Center

    Harron, Anita; Titterington, Jill

    2016-01-01

    Background: Professional standards advocate routine use of outcome measurement (OM) in the practice of allied health professionals (AHPs). Historically, OM has focused on impairment and its immediate constraints on activity, while current policy encourages the development and addition of impact-based OM. There appears to be an assumption at this…

  12. Knowledge Retention as a Latent Outcome Measure in Distance Learning.

    ERIC Educational Resources Information Center

    Wisher, Robert A.; Curnow, Christina K.; Seidel, Robert J.

    2001-01-01

    Describes two experiments that investigated the retention of knowledge as a latent measure of learning outcome in video teletraining courses, one for air traffic controllers and one for military training. Discusses the merits of knowledge retention as a construct for examining initial evidence of learning, especially for training related to the…

  13. What Do They Measure? Comparing Three Learning Outcomes Assessments

    ERIC Educational Resources Information Center

    Steedle, Jeffrey; Kugelmass, Heather; Nemeth, Alex

    2010-01-01

    Many postsecondary institutions currently administer standardized tests of general college outcomes; more than a quarter of Association of American Colleges and Universities (AAC&U) member institutions do so. Using standardized tests for accountability purposes has been contentious mainly because these tests do not measure every important outcome…

  14. Psychometric properties of the Spanish version of the Clinical Outcomes in Routine Evaluation – Outcome Measure

    PubMed Central

    Trujillo, Adriana; Feixas, Guillem; Bados, Arturo; García-Grau, Eugeni; Salla, Marta; Medina, Joan Carles; Montesano, Adrián; Soriano, José; Medeiros-Ferreira, Leticia; Cañete, Josep; Corbella, Sergi; Grau, Antoni; Lana, Fernando; Evans, Chris

    2016-01-01

    Objective The objective of this paper is to assess the reliability and validity of the Spanish translation of the Clinical Outcomes in Routine Evaluation – Outcome Measure, a 34-item self-report questionnaire that measures the client’s status in the domains of Subjective well-being, Problems/Symptoms, Life functioning, and Risk. Method Six hundred and forty-four adult participants were included in two samples: the clinical sample (n=192) from different mental health and primary care centers; and the nonclinical sample (n=452), which included a student and a community sample. Results The questionnaire showed good acceptability and internal consistency, appropriate test–retest reliability, and acceptable convergent validity. Strong differentiation between clinical and nonclinical samples was found. As expected, the Risk domain had different characteristics than other domains, but all findings were comparable with the UK referential data. Cutoff scores were calculated for clinical significant change assessment. Conclusion The Spanish version of the Clinical Outcomes in Routine Evaluation – Outcome Measure showed acceptable psychometric properties, providing support for using the questionnaire for monitoring the progress of Spanish-speaking psychotherapy clients. PMID:27382288

  15. Measurement of Outcomes of Upper Limb Reconstructive Surgery for Tetraplegia.

    PubMed

    Sinnott, K Anne; Dunn, Jennifer A; Wangdell, Johanna; Johanson, M Elise; Hall, Andrew S; Post, Marcel W

    2016-06-01

    Reconstructive arm/hand surgery for tetraplegia is performed to improve arm/hand function and therefore personal well-being for individuals who accept such elective surgeries. However, changes at an impairment level do not always translate into functional or quality of life changes. Therefore, multiple outcome tools should be used that incorporate sufficient responsiveness to detect changes in arm/hand function, activity and participation, and quality of life of the individuals involved. This narrative review aims to assist clinicians to choose the most appropriate tools to assess the need for reconstructive surgery and to evaluate its outcomes. Our specific objectives are (1) to describe aspects to consider when choosing a measure and (2) to describe the measures advised by an international therapist consensus group established in 2007. All advised measures are appraised in terms of the underlying construct, administration, and clinical relevance to arm/hand reconstructions. Essentially there are currently no criterion standard measures to evaluate the consequences of reconstructive arm/hand surgery. However, with judicious use of available measures it is possible to ensure the questions asked or tasks completed are relevant to the surgical reconstruction(s) undertaken. Further work in this field is required. This would be best met by immediate collaboration between 2 outcome's tool developers and by analysis of pre- and postoperative data already held in various international sites, which would allow further evaluation of the measures already in use, or components thereof. PMID:27233592

  16. Generating Outcome Measurements: Achievement and Attitudes. A Guide to Educational Outcome Measurements and Their Uses. Seminar No. 3.

    ERIC Educational Resources Information Center

    Mushkin, Selma J.; Billings, Bradley B.

    This guide is essentially designed as a teaching aid for those who would inform planners, officials of educational ministries, school administrators, principals, and teachers about educational outcome measurements. In outline and graphic form, the guide presents topics for discussion in a seminar dealing with how to obtain information on…

  17. Comparison of Physician-Predicted to Measured Low Vision Outcomes

    PubMed Central

    Chan, Tiffany L.; Goldstein, Judith E.; Massof, Robert W.

    2013-01-01

    Purpose To compare low vision rehabilitation (LVR) physicians’ predictions of the probability of success of LVR to patients’ self-reported outcomes after provision of usual outpatient LVR services; and to determine if patients’ traits influence physician ratings. Methods The Activity Inventory (AI), a self-report visual function questionnaire, was administered pre and post-LVR to 316 low vision patients served by 28 LVR centers that participated in a collaborative observational study. The physical component of the Short Form-36, Geriatric Depression Scale, and Telephone Interview for Cognitive Status were also administered pre-LVR to measure physical capability, depression and cognitive status. Following patient evaluation, 38 LVR physicians estimated the probability of outcome success (POS), using their own criteria. The POS ratings and change in functional ability were used to assess the effects of patients’ baseline traits on predicted outcomes. Results A regression analysis with a hierarchical random effects model showed no relationship between LVR physician POS estimates and AI-based outcomes. In another analysis, Kappa statistics were calculated to determine the probability of agreement between POS and AI-based outcomes for different outcome criteria. Across all comparisons, none of the kappa values were significantly different from 0, which indicates the rate of agreement is equivalent to chance. In an exploratory analysis, hierarchical mixed effects regression models show that POS ratings are associated with information about the patient’s cognitive functioning and the combination of visual acuity and functional ability, as opposed to visual acuity or functional ability alone. Conclusions Physicians’ predictions of LVR outcomes appear to be influenced by knowledge of patients’ cognitive functioning and the combination of visual acuity and functional ability - information physicians acquire from the patient’s history and examination. However

  18. Ultrasound cervical length measurement in prediction of labor induction outcome.

    PubMed

    Kehila, M; Abouda, H S; Sahbi, K; Cheour, H; Chanoufi, M Badis

    2016-05-17

    Induction of labor is one of the most common procedures in modern obstetrics, with an incidence of approximately 20% of all deliveries. Not all of these inductions result in vaginal delivery; some lead to cesarean sections, either for emergency reasons or for failed induction. That's why, It seems necessary to outline strategies for the improvement of the success rate of induced deliveries. Traditionally, the identification of women in whom labor induction is more likely to be successful is based on the Bishop score. However, several studies have shown it to be subjective, with high variation and a poor predictor of the outcome of labor induction. Transvaginal sonography for cervical measurement can be a more objective criterion in assessing the success of labor induction. Many studies have been done recently to compare cervical measurement and Bishop Score in labor induction.This paper reviewed the literature that evaluated sonographic cervical length measurement to predict induction of labor outcome.

  19. Breast Cancer EDGE Task Force Outcomes: Clinical Measures of Pain

    PubMed Central

    Harrington, Shana; Gilchrist, Laura; Sander, Antoinette

    2014-01-01

    Background Pain is one of the most commonly reported impairments after breast cancer treatment affecting anywhere from 16-73% of breast cancer survivors Despite the high reported incidence of pain from cancer and its treatments, the ability to evaluate cancer pain continues to be difficult due to the complexity of the disease and the subjective experience of pain. The Oncology Section Breast Cancer EDGE Task Force was created to evaluate the evidence behind clinical outcome measures of pain in women diagnosed with breast cancer. Methods The authors systematically reviewed the literature for pain outcome measures published in the research involving women diagnosed with breast cancer. The goal was to examine the reported psychometric properties that are reported in the literature in order to determine clinical utility. Results Visual Analog Scale, Numeric Rating Scale, Pressure Pain Threshold, McGill Pain Questionnaire, McGill Pain Questionnaire – Short Form, Brief Pain Inventory and Brief Pain Inventory – Short Form were highly recommended by the Task Force. The Task Force was unable to recommend two measures for use in the breast cancer population at the present time. Conclusions A variety of outcome measures were used to measure pain in women diagnosed with breast cancer. When assessing pain in women with breast cancer, researchers and clinicians need to determine whether a unidimensional or multidimensional tool is most appropriate as well as whether the tool has strong psychometric properties. PMID:25346950

  20. Outcome measures for palliative oxygen therapy: relevance and practical utility.

    PubMed

    Antoniu, Sabina; Mihaltan, Florin

    2014-06-01

    Dyspnea is a common symptom in many advanced malignant and non-malignant diseases and often is refractory to the usual therapies. In such circumstances palliative care approaches are necessary and among them palliative care oxygen therapy can be applied although currently its effectiveness is rather uncertain. Palliative oxygen therapy can be given on either continuous basis or on demand. Often the continuous palliative oxygen therapy is seen as long-term oxygen therapy although their aims are rather different. Palliative oxygen therapy was evaluated in populations with mixed underlying diseases, with outcome measures not only the most appropriate for the setting and therefore these limitations might have influenced the overall perceived therapeutic benefit. Therefore an evaluation of this method in subsets defined based on the etiology and pathogenic mechanisms and with appropriate outcome measures would help to better define the criteria for its indication and would increase its acceptability.

  1. Novel Outcome Measures for Clinical Trials in Cystic Fibrosis

    PubMed Central

    Tiddens, Harm AWM; Puderbach, Michael; Venegas, Jose G; Ratjen, Felix; Donaldson, Scott H; Davis, Stephanie D; Rowe, Steven M; Sagel, Scott D; Higgins, Mark; Waltz, David A

    2015-01-01

    Cystic fibrosis (CF) is a common inherited condition caused by mutations in the gene encoding the CF transmembrane regulator protein. With increased understanding of the molecular mechanisms underlying CF and the development of new therapies there comes the need to develop new outcome measures to assess the disease, its progression and response to treatment. As there are limitations to the current endpoints accepted for regulatory purposes, a workshop to discuss novel endpoints for clinical trials in CF was held in Anaheim, California in November 2011. The pros and cons of novel outcome measures with potential utility for evaluation of novel treatments in CF were critically evaluated. The highlights of the 2011 workshop and subsequent advances in technologies and techniques that could be used to inform the development of clinical trial endpoints are summarized in this review. Pediatr Pulmonol. © 2014 The Authors. Pediatric Pulmonology published by Wiley Periodicals, Inc. PMID:25641878

  2. Measurement outcomes and probability in Everettian quantum mechanics

    NASA Astrophysics Data System (ADS)

    Baker, David J.

    The decision-theoretic account of probability in the Everett or many-worlds interpretation, advanced by David Deutsch and David Wallace, is shown to be circular. Talk of probability in Everett presumes the existence of a preferred basis to identify measurement outcomes for the probabilities to range over. But the existence of a preferred basis can only be established by the process of decoherence, which is itself probabilistic.

  3. Outcome-Driven Thresholds for Home Blood Pressure Measurement

    PubMed Central

    Niiranen, Teemu J.; Asayama, Kei; Thijs, Lutgarde; Johansson, Jouni K.; Ohkubo, Takayoshi; Kikuya, Masahiro; Boggia, José; Hozawa, Atsushi; Sandoya, Edgardo; Stergiou, George S.; Tsuji, Ichiro; Jula, Antti M.; Imai, Yutaka; Staessen, Jan A.

    2013-01-01

    The lack of outcome-driven operational thresholds limits the clinical application of home blood pressure (BP) measurement. Our objective was to determine an outcome-driven reference frame for home BP measurement. We measured home and clinic BP in 6470 participants (mean age, 59.3 years; 56.9% women; 22.4% on antihypertensive treatment) recruited in Ohasama, Japan (n=2520); Montevideo, Uruguay (n=399); Tsurugaya, Japan (n=811); Didima, Greece (n=665); and nationwide in Finland (n=2075). In multivariable-adjusted analyses of individual subject data, we determined home BP thresholds, which yielded 10-year cardiovascular risks similar to those associated with stages 1 (120/80 mm Hg) and 2 (130/85 mm Hg) prehypertension, and stages 1 (140/90 mm Hg) and 2 (160/100 mm Hg) hypertension on clinic measurement. During 8.3 years of follow-up (median), 716 cardiovascular end points, 294 cardiovascular deaths, 393 strokes, and 336 cardiac events occurred in the whole cohort; in untreated participants these numbers were 414, 158, 225, and 194, respectively. In the whole cohort, outcome-driven systolic/diastolic thresholds for the home BP corresponding with stages 1 and 2 prehypertension and stages 1 and 2 hypertension were 121.4/77.7, 127.4/79.9, 133.4/82.2, and 145.4/86.8 mm Hg; in 5018 untreated participants, these thresholds were 118.5/76.9, 125.2/79.7, 131.9/82.4, and 145.3/87.9 mm Hg, respectively. Rounded thresholds for stages 1 and 2 prehypertension and stages 1 and 2 hypertension amounted to 120/75, 125/80, 130/85, and 145/90 mm Hg, respectively. Population-based outcome-driven thresholds for home BP are slightly lower than those currently proposed in hypertension guidelines. Our current findings could inform guidelines and help clinicians in diagnosing and managing patients. PMID:23129700

  4. Defining and measuring outcomes in end-stage dementia.

    PubMed

    Teno, J M; Landrum, K; Lynn, J

    1997-01-01

    Dementia is a life-defining illness that impacts both patients and their loved ones. For dying patients with dementia, there are important and meaningful outcomes that reflect the quality of care. The authors propose 13 domains to examine the quality of care and make the argument that for these patients and their families, measures of satisfaction and patient or family reports of specific events may be the most important markers of the quality of care.

  5. The Daily Activity Report (DAR) a Novel Measure of Functional Outcome for Serious Mental Illness

    PubMed Central

    Velligan, Dawn I.; Mintz, Jim; Sierra, Cynthia; Martin, Mona L.; Fredrick, Megan; Maglinte, Gregory A.; Corey-Lisle, Patricia K.

    2016-01-01

    The assessment of real-world functional outcomes in clinical trials for medications targeting negative symptoms and cognitive impairment is extremely important. We tested the psychometric properties of the Daily Activity Report (DAR), a novel assessment of productive daily activity. We administered the DAR and additional assessments of functional outcome, functional capacity, cognition and symptomatology to 50 individuals with schizophrenia at 2 time points, 1 month apart and to 25 healthy controls. The DAR records a person’s daily activity for 7 consecutive days based upon phone calls made 3 times a day. A total score and scores in 3 domains; instrumental activities (ie, independent living), social and work or school related activities are generated for the DAR. Inter-item consistency was high 0.89–0.94 for each domain and 0.88 overall. Test–retest reliability across 1 month for the total DAR score was 0.67, P < .0001. The total DAR score as well as scores for social activity and nondomestic work/school differed significantly between control and patient participants (P < .0001). DAR domain scores were associated with negative symptoms and functional outcomes, but the primary score related to these measures was the work/school dimension of the DAR. DAR scores were only weakly and nonsignificantly related to positive symptoms. This study provides preliminary support for the reliability and validity of the DAR using interviewer administration. The development of a patient reported version of the DAR using smart phone technology with automatic scoring is the next step. PMID:26712856

  6. Development of indicators for measuring outcomes of water safety plans

    PubMed Central

    Lockhart, Gabriella; Oswald, William E.; Hubbard, Brian; Medlin, Elizabeth; Gelting, Richard J.

    2015-01-01

    Water safety plans (WSPs) are endorsed by the World Health Organization as the most effective method of protecting a water supply. With the increase in WSPs worldwide, several valuable resources have been developed to assist practitioners in the implementation of WSPs, yet there is still a need for a practical and standardized method of evaluating WSP effectiveness. In 2012, the Centers for Disease Control and Prevention (CDC) published a conceptual framework for the evaluation of WSPs, presenting four key outcomes of the WSP process: institutional, operational, financial and policy change. In this paper, we seek to operationalize this conceptual framework by providing a set of simple and practical indicators for assessing WSP outcomes. Using CDC’s WSP framework as a foundation and incorporating various existing performance monitoring indicators for water utilities, we developed a set of approximately 25 indicators of institutional, operational, financial and policy change within the WSP context. These outcome indicators hold great potential for the continued implementation and expansion of WSPs worldwide. Having a defined framework for evaluating a WSP’s effectiveness, along with a set of measurable indicators by which to carry out that evaluation, will help implementers assess key WSP outcomes internally, as well as benchmark their progress against other WSPs in their region and globally. PMID:26361540

  7. Improving Patient Experience and Primary Care Quality for Patients With Complex Chronic Disease Using the Electronic Patient-Reported Outcomes Tool: Adopting Qualitative Methods Into a User-Centered Design Approach

    PubMed Central

    Khan, Anum Irfan; Kuluski, Kerry; McKillop, Ian; Sharpe, Sarah; Bierman, Arlene S; Lyons, Renee F; Cott, Cheryl

    2016-01-01

    Background Many mHealth technologies do not meet the needs of patients with complex chronic disease and disabilities (CCDDs) who are among the highest users of health systems worldwide. Furthermore, many of the development methodologies used in the creation of mHealth and eHealth technologies lack the ability to embrace users with CCDD in the specification process. This paper describes how we adopted and modified development techniques to create the electronic Patient-Reported Outcomes (ePRO) tool, a patient-centered mHealth solution to help improve primary health care for patients experiencing CCDD. Objective This paper describes the design and development approach, specifically the process of incorporating qualitative research methods into user-centered design approaches to create the ePRO tool. Key lessons learned are offered as a guide for other eHealth and mHealth research and technology developers working with complex patient populations and their primary health care providers. Methods Guided by user-centered design principles, interpretive descriptive qualitative research methods were adopted to capture user experiences through interviews and working groups. Consistent with interpretive descriptive methods, an iterative analysis technique was used to generate findings, which were then organized in relation to the tool design and function to help systematically inform modifications to the tool. User feedback captured and analyzed through this method was used to challenge the design and inform the iterative development of the tool. Results Interviews with primary health care providers (n=7) and content experts (n=6), and four focus groups with patients and carers (n=14) along with a PICK analysis—Possible, Implementable, (to be) Challenged, (to be) Killed—guided development of the first prototype. The initial prototype was presented in three design working groups with patients/carers (n=5), providers (n=6), and experts (n=5). Working group findings were

  8. Unconditionally secure bit commitment by transmitting measurement outcomes.

    PubMed

    Kent, Adrian

    2012-09-28

    We propose a new unconditionally secure bit commitment scheme based on Minkowski causality and the properties of quantum information. The receiving party sends a number of randomly chosen Bennett-Brassard 1984 (BB84) qubits to the committer at a given point in space-time. The committer carries out measurements in one of the two BB84 bases, depending on the committed bit value, and transmits the outcomes securely at (or near) light speed in opposite directions to remote agents. These agents unveil the bit by returning the outcomes to adjacent agents of the receiver. The protocol's security relies only on simple properties of quantum information and the impossibility of superluminal signalling. PMID:23030073

  9. Outcome measures and their everyday use in chiropractic practice

    PubMed Central

    Hinton, Paul M.; McLeod, Randall; Broker, Blaine; MacLellan, C. Elizabeth

    2010-01-01

    Objectives: To describe the extent to which chiropractors utilize standardized outcome and various clinical measures to systematically document patients’ baseline health status and responses to treatment, with particular consideration being given towards quantifiable outcome instruments. Study design: Cross-sectional mailed survey. Participants: Registered chiropractors in the province of Saskatchewan. Methods: A survey was mailed to all registrants of the Chiropractors’ Association of Saskatchewan. Respondents graded their frequency of using various standardized pencil-and-paper instruments and functional chiropractic, orthopaedic and neurological tests in the contexts of both the initial intake assessment (‘always,’ ‘commonly,’ ‘occasionally,’ or ‘never’) and the course of subsequent treatment (after ‘each visit,’ after ‘9–12 visits,’ ‘annually,’ when patient ‘not responding,’ on ‘dismissal/discharge,’ ‘never’ or for some ‘other’ reason). Data were tabulated for all item and response category combinations as frequencies and percentages using the total sample size as the denominator. Results: Of 164 registered chiropractors, 62 (38%) returned a completed questionnaire. A pain diagram was the most commonly used subjective outcome measure and was administered routinely (either “always” or “commonly”) by 75% of respondents, at either the initial consultation or during a subsequent visit. Numerical rating and visual analogue scales were less popular (routinely used by 59% and 42% respectively). The majority of respondents (80%) seldom (“occasionally” or “never”) used spine pain-specific disability indices such as the Low Back Revised Oswestry, Neck Disability Index or the Roland-Morris Questionnaire. As well, they did not use standardized psychosocial instruments such as the Beck Depression Index, or general health assessment measures such as the SF-36 or SF-12 questionnaire. Neurological testing was

  10. Relating acoustics and human outcome measures in hospitals

    NASA Astrophysics Data System (ADS)

    Hsu, Timothy Yuan-Ting

    Hospital noise has been an area of concern for medical professionals and researchers for the last century. Researchers have attempted to characterize the soundscape of hospital wards and have made some preliminary links between noise and human outcomes. In the past, most of the research has used traditional acoustic metrics. These traditional metrics, such as average sound level, are readily measured using sound level meters and have been the primary results reported in previous studies. However, it has been shown that these traditional metrics may be insufficient in fully characterizing the wards. The two studies presented here use traditional metrics and nontraditional metrics to define the soundscape of hospital wards. The uncovered links, between both sound level metrics and psychoacoustic metrics and patient physiological measurements, are discussed. Correlations and risk ratios demonstrate the presence and the strength of these relationships. These results demonstrate the relationships between hospital acoustics and patient physiological arousal. Additionally, the effects of adding absorption in a hospital ward are presented. Sound level, sound power, reverberation time and other acoustic metrics are directly affected. The speech intelligibility in these wards is evaluated in order to highlight the temporal nature of speech intelligibility. With both studies combined, both traditional and nontraditional acoustic measures are shown to have statistically significant relationships to both patient and staff outcomes.

  11. Outcome measures for evaluation of treatments for osteonecrosis.

    PubMed

    Jones, Lynne C; Hungerford, Marc W; Khanuja, Harpal S; Hungerford, David S

    2009-04-01

    With the advent of cell-based therapies, biologics, and pharmaceuticals for the potential treatment of osteonecrosis, it is important to conduct evaluations using scientifically accepted outcomes measures. For the treatment of osteonecrosis, most studies have focused on pain relief, surgery, or the need for surgery, disease progression (advancing stage), and change in lesion size. Quantification of imaging techniques continue to gain in sophistication but have not yet been validated for use in clinical trials. Despite recent interest in using biomarkers or genetic markers in the diagnosis and analysis of disease progression, more research is needed to determine the sensitivity and specificity of these techniques with respect to osteonecrosis.

  12. Measuring Outcomes for Young Children and Their Families. Outcome Indicators for Everyday Kids, Everyday Lives: A Vision for Pennsylvania's Children

    ERIC Educational Resources Information Center

    Trivette, Carol M.; Dunst, Carl J.

    2011-01-01

    This monograph includes the final report for a project funded by the Pennsylvania Developmental Disabilities Council for "Measuring Outcomes for Children" (2008 RFP). The goal of the project was to "develop and demonstrate the effectiveness of an instrument designed to measure life outcomes of children with disabilities being…

  13. Selecting Rehabilitation Outcome Measures for People with Multiple Sclerosis

    PubMed Central

    Potter, Kirsten; Allen, Diane D.; Bennett, Susan E.; Brandfass, Kathi G.; Widener, Gail L.; Yorke, Amy M.

    2015-01-01

    Despite the well-known benefits of using standardized outcome measures (OMs) in clinical practice, a variety of barriers interfere with their use. In particular, rehabilitation therapists lack sufficient knowledge in selecting appropriate OMs. The challenge is compounded when working with people with multiple sclerosis (MS) owing to heterogeneity of the patient population and symptom variability in individual patients. To help overcome these barriers, the American Physical Therapy Association appointed the Multiple Sclerosis Outcome Measures Task Force to review and make evidence-based recommendations for OM use in clinical practice, education, and research specific to people with MS. Sixty-three OMs were reviewed based on their clinical utility, psychometric properties, and a consensus evaluation of the appropriateness of use for people with MS. We sought to illustrate use of the recommendations for two cases. The first case involves a 43-year-old man with new-onset problems after an exacerbation. The second case pertains to an outpatient clinic interested in assessing the effectiveness of their MS rehabilitation program. For each case, clinicians identified areas that were important to assess and various factors deemed important for OM selection. Criteria were established and used to assist in OM selection. In both cases, the described processes narrowed the selection of OMs and assisted with choosing the most appropriate ones. The recommendations, in addition to the processes described in these two cases, can be used by clinicians in any setting working with patients with MS across the disability spectrum. PMID:26300704

  14. Intelligent outcome measures in liaison psychiatry: essential even if not desirable

    PubMed Central

    Tadros, George

    2016-01-01

    Service development is guided by outcome measures that inform service commissioners and providers. Those in liaison psychiatry should be encouraged to develop a positive approach that integrates the collection of outcome measures into everyday clinical practice. The Framework for Routine Outcome Measurement in Liaison Psychiatry (FROM-LP) is a very useful tool to measure service quality and clinical effectiveness, using a combination of clinician-rated and patient-rated outcome measures and patient-rated experience measures. However, it does not include measures of cost-effectiveness or training activities. The FROM-LP is a significant step towards developing nationally unified outcome measures. PMID:27512588

  15. Measuring the Outcome of Biomedical Research: A Systematic Literature Review

    PubMed Central

    Thonon, Frédérique; Boulkedid, Rym; Delory, Tristan; Rousseau, Sophie; Saghatchian, Mahasti; van Harten, Wim; O’Neill, Claire; Alberti, Corinne

    2015-01-01

    Background There is an increasing need to evaluate the production and impact of medical research produced by institutions. Many indicators exist, yet we do not have enough information about their relevance. The objective of this systematic review was (1) to identify all the indicators that could be used to measure the output and outcome of medical research carried out in institutions and (2) enlist their methodology, use, positive and negative points. Methodology We have searched 3 databases (Pubmed, Scopus, Web of Science) using the following keywords: [Research outcome* OR research output* OR bibliometric* OR scientometric* OR scientific production] AND [indicator* OR index* OR evaluation OR metrics]. We included articles presenting, discussing or evaluating indicators measuring the scientific production of an institution. The search was conducted by two independent authors using a standardised data extraction form. For each indicator we extracted its definition, calculation, its rationale and its positive and negative points. In order to reduce bias, data extraction and analysis was performed by two independent authors. Findings We included 76 articles. A total of 57 indicators were identified. We have classified those indicators into 6 categories: 9 indicators of research activity, 24 indicators of scientific production and impact, 5 indicators of collaboration, 7 indicators of industrial production, 4 indicators of dissemination, 8 indicators of health service impact. The most widely discussed and described is the h-index with 31 articles discussing it. Discussion The majority of indicators found are bibliometric indicators of scientific production and impact. Several indicators have been developed to improve the h-index. This indicator has also inspired the creation of two indicators to measure industrial production and collaboration. Several articles propose indicators measuring research impact without detailing a methodology for calculating them. Many

  16. Clinical evaluation of a mobile sensor-based gait analysis method for outcome measurement after knee arthroplasty.

    PubMed

    Calliess, Tilman; Bocklage, Raphael; Karkosch, Roman; Marschollek, Michael; Windhagen, Henning; Schulze, Mareike

    2014-08-28

    Clinical scores and motion-capturing gait analysis are today's gold standard for outcome measurement after knee arthroplasty, although they are criticized for bias and their ability to reflect patients' actual quality of life has been questioned. In this context, mobile gait analysis systems have been introduced to overcome some of these limitations. This study used a previously developed mobile gait analysis system comprising three inertial sensor units to evaluate daily activities and sports. The sensors were taped to the lumbosacral junction and the thigh and shank of the affected limb. The annotated raw data was evaluated using our validated proprietary software. Six patients undergoing knee arthroplasty were examined the day before and 12 months after surgery. All patients reported a satisfactory outcome, although four patients still had limitations in their desired activities. In this context, feasible running speed demonstrated a good correlation with reported impairments in sports-related activities. Notably, knee flexion angle while descending stairs and the ability to stop abruptly when running exhibited good correlation with the clinical stability and proprioception of the knee. Moreover, fatigue effects were displayed in some patients. The introduced system appears to be suitable for outcome measurement after knee arthroplasty and has the potential to overcome some of the limitations of stationary gait labs while gathering additional meaningful parameters regarding the force limits of the knee.

  17. Clinical Evaluation of a Mobile Sensor-Based Gait Analysis Method for Outcome Measurement after Knee Arthroplasty

    PubMed Central

    Calliess, Tilman; Bocklage, Raphael; Karkosch, Roman; Marschollek, Michael; Windhagen, Henning; Schulze, Mareike

    2014-01-01

    Clinical scores and motion-capturing gait analysis are today's gold standard for outcome measurement after knee arthroplasty, although they are criticized for bias and their ability to reflect patients' actual quality of life has been questioned. In this context, mobile gait analysis systems have been introduced to overcome some of these limitations. This study used a previously developed mobile gait analysis system comprising three inertial sensor units to evaluate daily activities and sports. The sensors were taped to the lumbosacral junction and the thigh and shank of the affected limb. The annotated raw data was evaluated using our validated proprietary software. Six patients undergoing knee arthroplasty were examined the day before and 12 months after surgery. All patients reported a satisfactory outcome, although four patients still had limitations in their desired activities. In this context, feasible running speed demonstrated a good correlation with reported impairments in sports-related activities. Notably, knee flexion angle while descending stairs and the ability to stop abruptly when running exhibited good correlation with the clinical stability and proprioception of the knee. Moreover, fatigue effects were displayed in some patients. The introduced system appears to be suitable for outcome measurement after knee arthroplasty and has the potential to overcome some of the limitations of stationary gait labs while gathering additional meaningful parameters regarding the force limits of the knee. PMID:25171119

  18. Measurement and determinants of tuberculosis outcome in Karonga District, Malawi.

    PubMed Central

    Glynn, J. R.; Warndorff, D. K.; Fine, P. E.; Munthali, M. M.; Sichone, W.; Pönnighaus, J. M.

    1998-01-01

    Evaluation of disease outcome is central to the assessment of tuberculosis (TB) control programmes. In the study reported in this article we examined the factors influencing the measurement of outcome, survival rates during and after treatment, smear conversion rates, and relapse rates for patients diagnosed with TB in a rural area of Malawi between 1986 and mid-1994. Patients with less certain diagnoses of TB were more likely to die than those with confirmed TB, both among those who were seropositive and those who were seronegative to human immunodeficiency virus (HIV). The mortality rate among smear-positive patients with a separate culture-positive specimen was half that of patients with no such diagnostic confirmation. Patients not registered by the Ministry of Health had much higher mortality and default rates than did registered patients. Among smear-positive patients, HIV serostatus was the most important influence on mortality both during and after treatment (crude hazard ratios (95% confidence intervals) = 5.6 (3.0-10) and 7.7 (3.4-17), resp.), but HIV serostatus did not influence smear conversion rates. The initial degree of smear positivity influenced smear conversion rates, but not mortality rates. No significant predictors of relapse were identified. Unless considerable care is taken to include all TB patients, and to exclude nontuberculous patients, recorded TB outcome statistics are difficult to interpret and may be misleading. In populations with high rates of HIV infection, TB target cure rates of 85% are unrealistic. When new interventions are assessed it cannot be assumed that factors which influence the smear conversion rate will also influence the mortality rate. PMID:9744250

  19. Directly measured second hand smoke exposure and asthma health outcomes

    PubMed Central

    Eisner, M; Klein, J; Hammond, S; Koren, G; Lactao, G; Iribarren, C

    2005-01-01

    Background: Because they have chronic airway inflammation, adults with asthma could have symptomatic exacerbation after exposure to second hand smoke (SHS). Surprisingly, data on the effects of SHS exposure in adults with asthma are quite limited. Most previous epidemiological studies used self-reported SHS exposure which could be biased by inaccurate reporting. In a prospective cohort study of adult non-smokers recently admitted to hospital for asthma, the impact of SHS exposure on asthma health outcomes was examined. Methods: Recent SHS exposure during the previous 7 days was directly measured using a personal nicotine badge (n = 189) and exposure during the previous 3 months was estimated using hair nicotine and cotinine levels (n = 138). Asthma severity and health status were ascertained during telephone interviews, and subsequent admission to hospital for asthma was determined from computerised utilisation databases. Results: Most of the adults with asthma were exposed to SHS, with estimates ranging from 60% to 83% depending on the time frame and methodology. The highest level of recent SHS exposure, as measured by the personal nicotine badge, was related to greater asthma severity (mean score increment for highest tertile of nicotine level 1.56 points; 95% CI 0.18 to 2.95), controlling for sociodemographic covariates and previous smoking history. Moreover, the second and third tertiles of hair nicotine exposure during the previous month were associated with a greater baseline prospective risk of hospital admission for asthma (HR 3.73; 95% CI 1.04 to 13.30 and HR 3.61; 95% CI 1.0 to 12.9, respectively). Conclusions: Directly measured SHS exposure appears to be associated with poorer asthma outcomes. In public health terms, these results support efforts to prohibit smoking in public places. PMID:16192366

  20. Vision and vision-related outcome measures in multiple sclerosis.

    PubMed

    Balcer, Laura J; Miller, David H; Reingold, Stephen C; Cohen, Jeffrey A

    2015-01-01

    Visual impairment is a key manifestation of multiple sclerosis. Acute optic neuritis is a common, often presenting manifestation, but visual deficits and structural loss of retinal axonal and neuronal integrity can occur even without a history of optic neuritis. Interest in vision in multiple sclerosis is growing, partially in response to the development of sensitive visual function tests, structural markers such as optical coherence tomography and magnetic resonance imaging, and quality of life measures that give clinical meaning to the structure-function correlations that are unique to the afferent visual pathway. Abnormal eye movements also are common in multiple sclerosis, but quantitative assessment methods that can be applied in practice and clinical trials are not readily available. We summarize here a comprehensive literature search and the discussion at a recent international meeting of investigators involved in the development and study of visual outcomes in multiple sclerosis, which had, as its overriding goals, to review the state of the field and identify areas for future research. We review data and principles to help us understand the importance of vision as a model for outcomes assessment in clinical practice and therapeutic trials in multiple sclerosis. PMID:25433914

  1. Vision and vision-related outcome measures in multiple sclerosis.

    PubMed

    Balcer, Laura J; Miller, David H; Reingold, Stephen C; Cohen, Jeffrey A

    2015-01-01

    Visual impairment is a key manifestation of multiple sclerosis. Acute optic neuritis is a common, often presenting manifestation, but visual deficits and structural loss of retinal axonal and neuronal integrity can occur even without a history of optic neuritis. Interest in vision in multiple sclerosis is growing, partially in response to the development of sensitive visual function tests, structural markers such as optical coherence tomography and magnetic resonance imaging, and quality of life measures that give clinical meaning to the structure-function correlations that are unique to the afferent visual pathway. Abnormal eye movements also are common in multiple sclerosis, but quantitative assessment methods that can be applied in practice and clinical trials are not readily available. We summarize here a comprehensive literature search and the discussion at a recent international meeting of investigators involved in the development and study of visual outcomes in multiple sclerosis, which had, as its overriding goals, to review the state of the field and identify areas for future research. We review data and principles to help us understand the importance of vision as a model for outcomes assessment in clinical practice and therapeutic trials in multiple sclerosis.

  2. Cost-Outcome Analysis: Measuring Outcomes. Evaluation Guides: Guide Number 4.

    ERIC Educational Resources Information Center

    Smith, Jana K.

    The second of two related pamphlets, this guide describes how to design an outcome study and outlines procedures for collecting outcome data. After an introduction that delineates the purpose of the two-part series, the pamphlet is divided into four major sections. The first section explains how to select a cost-outcome analysis. The next three…

  3. Exploring the Implementation and Use of Outcome Measurement in Practice: A Qualitative Study

    ERIC Educational Resources Information Center

    Skeat, J.; Perry, A.

    2008-01-01

    Background: Outcome measurement is important to clinical practice--yet outcome many speech and language therapists find it difficult to apply measures in practice, and not all clinicians and services have been able to implement and/or use outcome measurement successfully. To date there has been little research to explain why implementation is…

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

    ERIC Educational Resources Information Center

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

    2010-01-01

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

  5. The King's Outcome Scale for Childhood Head Injury and Injury Severity and Outcome Measures in Children with Traumatic Brain Injury

    ERIC Educational Resources Information Center

    Calvert, Sophie; Miller, Helen E.; Curran, Andrew; Hameed, Biju; McCarter, Renee; Edwards, Richard J.; Hunt, Linda; Sharples, Peta Mary

    2008-01-01

    The aim of this study was to relate discharge King's Outcome Scale for Childhood Head Injury (KOSCHI) category to injury severity and detailed outcome measures obtained in the first year post-traumatic brain injury (TBI). We used a prospective cohort study. Eighty-one children with TBI were studied: 29 had severe, 15 moderate, and 37 mild TBI. The…

  6. Outcome measures for clinical drug trials in autism.

    PubMed

    Aman, Michael G; Novotny, Sherie; Samango-Sprouse, Carole; Lecavalier, Luc; Leonard, Elizabeth; Gadow, Kenneth D; King, Bryan H; Pearson, Deborah A; Gernsbacher, Morton Ann; Chez, Michael

    2004-01-01

    This paper identifies instruments and measures that may be appropriate for randomized clinical trials in participants with autism spectrum disorders (ASDs). The Clinical Global Impressions scale was recommended for all randomized clinical trials. At this point, however, there is no "perfect" choice of outcome measure for core features of autism, although we will discuss five measures of potential utility. Several communication instruments are recommended, based in part on suitability across the age range. In trials where the intention is to alter core features of ASDs, adaptive behavior scales are also worthy of consideration. Several "behavior complexes" common to ASDs are identified, and instruments are recommended for assessment of these. Given the prevalence of cognitive impairment in ASDs, it is important to assess any cognitive effects, although cognitive data from ASD randomized clinical trials, thus far, are minimal. Guidance from trials in related pharmacologic areas and behavioral pharmacology may be helpful. We recommend routine elicitation of side effects, height and weight, vital signs, and (in the case of antipsychotics) extrapyramidal side-effects assessment. It is often appropriate to include laboratory tests and assessments for continence and sleep pattern.

  7. Measuring psychotherapy outcomes with the Behavioral Health Measure-20: Efficient and comprehensive.

    PubMed

    Kopta, Mark; Owen, Jesse; Budge, Stephanie

    2015-12-01

    The Behavioral Health Measure-20 (BHM-20; Kopta & Lowry, 2002) through the computer-based CelestHealth System-MH (CHS-MH) has proven to be an effective and efficient instrument for assessing psychotherapy outcomes and providing feedback to psychotherapists. This article describes its features, the psychometric and research support of the measure, as well as its use in clinical training and practice. Additionally, we offer some hopes and possibilities for the future of clinical feedback systems.

  8. Results of a two-year pilot study of clinical outcome measures in collagen VI- and laminin alpha2-related congenital muscular dystrophies.

    PubMed

    Meilleur, Katherine G; Jain, Minal S; Hynan, Linda S; Shieh, Ching-Yi; Kim, Eunice; Waite, Melissa; McGuire, Michelle; Fiorini, Courtney; Glanzman, Allan M; Main, Marion; Rose, Kristy; Duong, Tina; Bendixen, Roxanna; Linton, Melody M; Arveson, Irene C; Nichols, Carmel; Yang, Kelly; Fischbeck, Kenneth H; Wagner, Kathryn R; North, Kathryn; Mankodi, Ami; Grunseich, Christopher; Hartnett, Elizabeth J; Smith, Michaele; Donkervoort, Sandra; Schindler, Alice; Kokkinis, Angela; Leach, Meganne; Foley, A Reghan; Collins, James; Muntoni, Francesco; Rutkowski, Anne; Bönnemann, Carsten G

    2015-01-01

    Potential therapies are currently under development for two congenital muscular dystrophy (CMD) subtypes: collagen VI-related muscular dystrophy (COL6-RD) and laminin alpha 2-related dystrophy (LAMA2-RD). However, appropriate clinical outcome measures to be used in clinical trials have not been validated in CMDs. We conducted a two-year pilot study to evaluate feasibility, reliability, and validity of various outcome measures, particularly the Motor Function Measure 32, in 33 subjects with COL6-RD and LAMA2-RD. In the first year, outcome measures tested included: Motor Function Measure 32 (MFM32), forced vital capacity (FVC) percent predicted sitting, myometry, goniometry, 10-meter walk, Egen Klassification 2, and PedsQL(TM) Generic and Neuromuscular Cores. In the second year, we added the North Star Ambulatory Assessment (NSAA), Hammersmith Functional Motor Scale (HFMS), timed functional tests, Measure of Activity Limitations (ACTIVLIM), Quality of Upper Extremity Skills Test (QUEST), and Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue subscale. The MFM32 showed strong inter-rater (0.92) and internal consistency (0.96) reliabilities. Concurrent validity for the MFM32 was supported by large correlations (range 0.623-0.936) with the following: FVC, NSAA, HFMS, timed functional tests, ACTIVLIM, and QUEST. Significant correlations of the MFM32 were also found with select myometry measurements, mainly of the proximal extremities and domains of the PedsQL(TM) scales focusing on physical health and neuromuscular disease. Goniometry measurements were less reliable. The Motor Function Measure is reliable and valid in the two specific subtypes of CMD evaluated, COL6-RD and LAMA2-RD. The NSAA is useful as a complementary outcome measure in ambulatory individuals. Preliminary concurrent validity of several other clinical outcome measures was also demonstrated for these subtypes. PMID:25307854

  9. Quantifying prosthetic gait deviation using simple outcome measures

    PubMed Central

    Kark, Lauren; Odell, Ross; McIntosh, Andrew S; Simmons, Anne

    2016-01-01

    AIM: To develop a subset of simple outcome measures to quantify prosthetic gait deviation without needing three-dimensional gait analysis (3DGA). METHODS: Eight unilateral, transfemoral amputees and 12 unilateral, transtibial amputees were recruited. Twenty-eight able-bodied controls were recruited. All participants underwent 3DGA, the timed-up-and-go test and the six-minute walk test (6MWT). The lower-limb amputees also completed the Prosthesis Evaluation Questionnaire. Results from 3DGA were summarised using the gait deviation index (GDI), which was subsequently regressed, using stepwise regression, against the other measures. RESULTS: Step-length (SL), self-selected walking speed (SSWS) and the distance walked during the 6MWT (6MWD) were significantly correlated with GDI. The 6MWD was the strongest, single predictor of the GDI, followed by SL and SSWS. The predictive ability of the regression equations were improved following inclusion of self-report data related to mobility and prosthetic utility. CONCLUSION: This study offers a practicable alternative to quantifying kinematic deviation without the need to conduct complete 3DGA. PMID:27335814

  10. Novel mechanisms, treatments, and outcome measures in childhood sleep.

    PubMed

    Colonna, Annalisa; Smith, Anna B; Pal, Deb K; Gringras, Paul

    2015-01-01

    Sleep disorders and sleep of insufficient duration and quality are on the increase due to changes in our lifestyle, particularly in children and adolescents. Sleep disruption is also more common in children with medical conditions, compounding their difficulties. Recent studies have focused on new mechanisms that explain how learning and cognitive performance depend on a good night's sleep. Growing alongside this latest understanding is an innovative new field of non-drug interventions that improve sleep architecture, with resulting cognitive improvements. However, we need to rigorously evaluate such potentially popular and self-administered sleep interventions with equally state-of-the-art outcome measurement tools. Animated hand-held games, that incorporate embedded sleep-dependent learning tasks, promise to offer new robust methods of measuring changes in overnight learning. Portable computing technology has the potential to offer practical, inexpensive and reliable tools to indirectly assess the quality of sleep. They may be adopted in both clinical and educational settings, providing a unique way of monitoring the effect of sleep disruption on learning, leading also to a radical rethink of how we manage chronic diseases. PMID:26029140

  11. Novel mechanisms, treatments, and outcome measures in childhood sleep.

    PubMed

    Colonna, Annalisa; Smith, Anna B; Pal, Deb K; Gringras, Paul

    2015-01-01

    Sleep disorders and sleep of insufficient duration and quality are on the increase due to changes in our lifestyle, particularly in children and adolescents. Sleep disruption is also more common in children with medical conditions, compounding their difficulties. Recent studies have focused on new mechanisms that explain how learning and cognitive performance depend on a good night's sleep. Growing alongside this latest understanding is an innovative new field of non-drug interventions that improve sleep architecture, with resulting cognitive improvements. However, we need to rigorously evaluate such potentially popular and self-administered sleep interventions with equally state-of-the-art outcome measurement tools. Animated hand-held games, that incorporate embedded sleep-dependent learning tasks, promise to offer new robust methods of measuring changes in overnight learning. Portable computing technology has the potential to offer practical, inexpensive and reliable tools to indirectly assess the quality of sleep. They may be adopted in both clinical and educational settings, providing a unique way of monitoring the effect of sleep disruption on learning, leading also to a radical rethink of how we manage chronic diseases.

  12. Novel mechanisms, treatments, and outcome measures in childhood sleep

    PubMed Central

    Colonna, Annalisa; Smith, Anna B.; Pal, Deb K.; Gringras, Paul

    2015-01-01

    Sleep disorders and sleep of insufficient duration and quality are on the increase due to changes in our lifestyle, particularly in children and adolescents. Sleep disruption is also more common in children with medical conditions, compounding their difficulties. Recent studies have focused on new mechanisms that explain how learning and cognitive performance depend on a good night’s sleep. Growing alongside this latest understanding is an innovative new field of non-drug interventions that improve sleep architecture, with resulting cognitive improvements. However, we need to rigorously evaluate such potentially popular and self-administered sleep interventions with equally state-of-the-art outcome measurement tools. Animated hand-held games, that incorporate embedded sleep-dependent learning tasks, promise to offer new robust methods of measuring changes in overnight learning. Portable computing technology has the potential to offer practical, inexpensive and reliable tools to indirectly assess the quality of sleep. They may be adopted in both clinical and educational settings, providing a unique way of monitoring the effect of sleep disruption on learning, leading also to a radical rethink of how we manage chronic diseases. PMID:26029140

  13. An Outcome Measure of Functionality and Pain in Patients with Low Back Disorder: A Validation Study of the Iranian version of Low Back Outcome Score

    PubMed Central

    Nayeb Aghaei, Hossein; Azhari, Shirzad; Shazadi, Sohrab; Khayat Kashany, Hamid; Mohammadi, Hassan Reza; Montazeri, Ali

    2016-01-01

    Study Design Cross-sectional study. Purpose This study aimed to cross-culturally translate and validate the low back outcome score (LBOS) in Iran. Overview of Literature Lumbar disc hernia (LDH) is the most common diagnoses of low back pain and imposes a heavy burden on both individual and society. Instruments measuring patient reported outcomes should satisfy cetain psychometric properties. Methods The translation and cross-cultural adaptation of the original questionnaire was performed using Beaton's guideline. A total of 163 patients with LDH were asked to respond to the questionnaire at three points in time: preoperative and twice within 1-week interval after surgery assessments. The Oswestry disabilty index (ODI) was also completed. The internal consistency, test-retest, convergent validity, and responsiveness to change were assessed. Responsiveness to change also was assessed comparing patients' pre- and postoperative scores. Results The mean age of the cohort was 49.8 years (standard deviation=10.1). The Cronbach's alpha coefficients for the LBOS at preoperative and postoperative assessments ranged from 0.77 to 0.79, indicating good internal consistency. Test-retest reliability as performed by intraclass correlation coefficient was found to be 0.82 (0.62–0.91). The instrument discriminated well between sub-groups of patients who differed in the Finneson-Cooper score. The ODI correlated strongly with the LBOS score, lending support to its good convergent validity (r=––0.83; p<0.001). Further analysis also indicated that the questionnaire was responsive to change (p<0.001). Conclusions The Iranian version of LBOS performed well and the findings suggest that it is a valid measure of back pain treatment evaluation among LDH patients. PMID:27559453

  14. Measuring health-related quality of life outcomes in head and neck reconstruction.

    PubMed

    Albornoz, Claudia R; Pusic, Andrea L; Reavey, Patrick; Scott, Amie M; Klassen, Anne F; Cano, Stefan J; Cordeiro, Peter G; Matros, Evan

    2013-04-01

    A qualitative study was undertaken to understand the impact of omitted health concepts in existing patient-reported outcome (PRO) instruments for health-related quality of life (HR-QOL) evaluation following head and neck (H&N) cancer reconstruction. Twenty-six patients were interviewed. Patients described a broad range of symptoms. Oral competence, rhinorrhea, facial sensation, smile, vision and eye discharge are missing from existing PRO instruments. Altered appearance was a major stressor; both function and appearance changes had a negative psychosocial impact leading to social isolation and embarrassment. This framework is the foundation for development of a more complete PRO instrument, the FACE-Q Oncology. PMID:23506775

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

    ERIC Educational Resources Information Center

    Zainuba, Mohamed; Rahal, Ahmad

    2012-01-01

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

  16. Outcome measures in acute gout: a systematic literature review

    PubMed Central

    Dalbeth, Nicola; Zhong, Cathy S; Grainger, Rebecca; Khanna, Dinesh; Khanna, Puja P; Singh, Jasvinder A; McQueen, Fiona M; Taylor, William J

    2014-01-01

    Objective Five core domains have been endorsed by Outcomes Measures in Rheumatology (OMERACT) for acute gout: pain, joint swelling, joint tenderness, patient global assessment, and activity limitation. The aim of this work was to evaluate instruments for these domains according to the OMERACT filter: truth, feasibility, and discrimination. Methods A systematic search strategy for instruments used to measure the acute gout core domains was formulated. For each method, articles were assessed by two reviewers to summarise information according to the specific components of the OMERACT filter. Results Seventy-seven articles and abstracts met the inclusion criteria. Pain was most frequently reported (76 studies, 20 instruments). The pain instruments used most often were 100mm visual analog scale (VAS) and 5-point Likert scale. Both methods have high feasibility, face and content validity, within- and between-group discrimination. Four-point Likert scales assessing index joint swelling and tenderness have been used in numerous acute gout studies; these instruments are feasible, with high face and content validity, and show within- and between-group discrimination. Five-point patient global assessment of response to treatment (PGART) scales are feasible and valid, and show within- and between-group discrimination. Measures of activity limitations were infrequently reported, and insufficient data were available to make definite assessments of the instruments for this domain. Conclusion Many different instruments have been used to assess the acute gout core domains. Pain VAS and 5-point Likert scales, 4-point Likert scales of index joint swelling and tenderness and 5-point PGART instruments meet the criteria for the OMERACT filter. PMID:24334652

  17. Systematic Review of Outcome Measures Reported in Clinical Canine Osteoarthritis Research

    PubMed Central

    Asher, Lucy; Dean, Rachel S.

    2016-01-01

    Objective To record and categorize the outcome measures used in dogs with naturally occurring osteoarthritis (OA) by systematically reviewing the peer reviewed publications on OA in dogs. Study Design Systematic literature review. Study Population Peer reviewed literature on canine OA. Methods A computer‐based bibliographic search was performed on PubMed and CAB Abstracts in August 2013 to find peer reviewed publications relevant to canine OA. Inclusion and exclusion criteria were applied. The outcome measures reported within each publication were recorded and categorized for comparison. Adequately described outcome measures were assessed for uniqueness and evidence of prior validation. Results Of 3,697 publications identified and screened, 117 were deemed eligible for inclusion. Within eligible publications, outcome measures were used 618 times (median of 4 outcome measures per publication). Outcomes measured were divided into 5 groups containing 65 categories. The most frequently assessed outcomes were lameness assessment with no stated gait/mixed gaits (66 outcomes), radiography (58), and lameness single gait/lateral motion (55). Of 618 outcome measures reported, 491 were assessed for uniqueness and 348 (71%) were unique to a single publication. Ten outcome measures were reported to have been validated. Conclusion Many outcome measures have been used to assess canine OA. There is no consensus on which are the most useful outcomes or by which method they should be assessed. There is a pressing need for agreement on outcomes reporting in canine OA and for validation of outcome measures used for these assessments. Until consensus is reached, we recommend at least one validated outcome measure be used in every clinical study. PMID:27120270

  18. Body composition changes in pregnancy: measurement, predictors and outcomes

    PubMed Central

    Widen, EM; Gallagher, D

    2014-01-01

    Prevalence of overweight and obesity has risen in the United States over the past few decades. Concurrent with this rise in obesity has been an increase in pregravid body mass index and gestational weight gain affecting maternal body composition changes in pregnancy. During pregnancy, many of the assumptions inherent in body composition estimation are violated, particularly the hydration of fat-free mass, and available methods are unable to disentangle maternal composition from fetus and supporting tissues; therefore, estimates of maternal body composition during pregnancy are prone to error. Here we review commonly used and available methods for assessing body composition changes in pregnancy, including: (1) anthropometry, (2) total body water, (3) densitometry, (4) imaging, (5) dual-energy X-ray absorptiometry, (6) bioelectrical impedance and (7) ultrasound. Several of these methods can measure regional changes in adipose tissue; however, most of these methods provide only whole-body estimates of fat and fat-free mass. Consideration is given to factors that may influence changes in maternal body composition, as well as long-term maternal and offspring outcomes. Finally, we provide recommendations for future research in this area. PMID:24667754

  19. Measuring Networking as an Outcome Variable in Undergraduate Research Experiences

    PubMed Central

    Hanauer, David I.; Hatfull, Graham

    2015-01-01

    The aim of this paper is to propose, present, and validate a simple survey instrument to measure student conversational networking. The tool consists of five items that cover personal and professional social networks, and its basic principle is the self-reporting of degrees of conversation, with a range of specific discussion partners. The networking instrument was validated in three studies. The basic psychometric characteristics of the scales were established by conducting a factor analysis and evaluating internal consistency using Cronbach’s alpha. The second study used a known-groups comparison and involved comparing outcomes for networking scales between two different undergraduate laboratory courses (one involving a specific effort to enhance networking). The final study looked at potential relationships between specific networking items and the established psychosocial variable of project ownership through a series of binary logistic regressions. Overall, the data from the three studies indicate that the networking scales have high internal consistency (α = 0.88), consist of a unitary dimension, can significantly differentiate between research experiences with low and high networking designs, and are related to project ownership scales. The ramifications of the networking instrument for student retention, the enhancement of public scientific literacy, and the differentiation of laboratory courses are discussed. PMID:26538387

  20. Measuring Networking as an Outcome Variable in Undergraduate Research Experiences.

    PubMed

    Hanauer, David I; Hatfull, Graham

    2015-01-01

    The aim of this paper is to propose, present, and validate a simple survey instrument to measure student conversational networking. The tool consists of five items that cover personal and professional social networks, and its basic principle is the self-reporting of degrees of conversation, with a range of specific discussion partners. The networking instrument was validated in three studies. The basic psychometric characteristics of the scales were established by conducting a factor analysis and evaluating internal consistency using Cronbach's alpha. The second study used a known-groups comparison and involved comparing outcomes for networking scales between two different undergraduate laboratory courses (one involving a specific effort to enhance networking). The final study looked at potential relationships between specific networking items and the established psychosocial variable of project ownership through a series of binary logistic regressions. Overall, the data from the three studies indicate that the networking scales have high internal consistency (α = 0.88), consist of a unitary dimension, can significantly differentiate between research experiences with low and high networking designs, and are related to project ownership scales. The ramifications of the networking instrument for student retention, the enhancement of public scientific literacy, and the differentiation of laboratory courses are discussed. PMID:26538387

  1. Measuring Networking as an Outcome Variable in Undergraduate Research Experiences.

    PubMed

    Hanauer, David I; Hatfull, Graham

    2015-01-01

    The aim of this paper is to propose, present, and validate a simple survey instrument to measure student conversational networking. The tool consists of five items that cover personal and professional social networks, and its basic principle is the self-reporting of degrees of conversation, with a range of specific discussion partners. The networking instrument was validated in three studies. The basic psychometric characteristics of the scales were established by conducting a factor analysis and evaluating internal consistency using Cronbach's alpha. The second study used a known-groups comparison and involved comparing outcomes for networking scales between two different undergraduate laboratory courses (one involving a specific effort to enhance networking). The final study looked at potential relationships between specific networking items and the established psychosocial variable of project ownership through a series of binary logistic regressions. Overall, the data from the three studies indicate that the networking scales have high internal consistency (α = 0.88), consist of a unitary dimension, can significantly differentiate between research experiences with low and high networking designs, and are related to project ownership scales. The ramifications of the networking instrument for student retention, the enhancement of public scientific literacy, and the differentiation of laboratory courses are discussed.

  2. Accountability in Continuing Education: Measuring Noncredit Student Outcomes.

    ERIC Educational Resources Information Center

    Clagett, Craig A.; McConochie, Daniel D.

    1991-01-01

    Although only Ohio has issued statewide standards for noncredit continuing education and a few other states have looked at such a process, most of the literature on student outcomes focuses exclusively on degree-credit programs. A college, university, or state system might want to assess continuing education outcomes for the following reasons: to…

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

    PubMed

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

    2012-02-01

    Use of outcome measures in physical therapy practice is central to evaluating the effectiveness of treatment interventions, providing accountability and addressing quality of physical therapy programs. There is limited discussion on barriers and facilitators to using outcome measures in physical therapy practice. The purpose of this study was to identify factors that influence a physical therapist when deciding to use outcome measures in clinical practice. Participants were 21 physical therapists, seven each from skilled nursing facilities, outpatient clinics, and inpatient rehabilitation facilities. A grounded theory approach was used for interview and data collection. Common themes were determined from the data and a theory developed to explain the rationale behind physical therapists' decisions to use or not use outcome measures in clinical practice. Three overlapping themes related to (1) concepts of time, (2) knowledge, and (3) facility culture were indentified as factors influencing the use of outcome measures. A fourth encompassing theme, professionalism, identified the value placed on the use of outcome measures in practice. Data revealed that therapists require more information on the outcome measures available, and this information needs to be easily accessible within the workplace. Therapists value information generated by using outcome measures in the clinical setting, but need information on what measures are available and psychometric properties. Information must be easily accessible and measures easy to use. Newer graduates and recent learners have a foundation in the use of outcome measures, but more needs to be done in the clinic and through continuing education to promote increased use and understanding. PMID:21877943

  4. Access to Transplantation and Transplant Outcome Measures (ATTOM): study protocol of a UK wide, in-depth, prospective cohort analysis

    PubMed Central

    Oniscu, Gabriel C; Ravanan, Rommel; Wu, Diana; Gibbons, Andrea; Li, Bernadette; Tomson, Charles; Forsythe, John L; Bradley, Clare; Cairns, John; Dudley, Christopher; Watson, Christopher J E; Bolton, Eleanor M; Draper, Heather; Robb, Matthew; Bradbury, Lisa; Pruthi, Rishi; Metcalfe, Wendy; Fogarty, Damian; Roderick, Paul; Bradley, J Andrew

    2016-01-01

    Introduction There is significant intercentre variability in access to renal transplantation in the UK due to poorly understood factors. The overarching aims of this study are to improve equity of access to kidney and kidney–pancreas transplantation across the UK and to optimise organ allocation to maximise the benefit and cost-effectiveness of transplantation. Methods and analysis 6844 patients aged 18–75 years starting dialysis and/or receiving a transplant together with matched patients active on the transplant list from all 72 UK renal units were recruited between November 2011 and March 2013 and will be followed for at least 3 years. The outcomes of interest include patient survival, access to the transplant list, receipt of a transplant, patient-reported outcome measures (PROMs) including quality of life, treatment satisfaction, well-being and health status on different forms of renal replacement therapy. Sociodemographic and clinical data were prospectively collected from case notes and from interviews with patients and local clinical teams. Qualitative process exploration with clinical staff will help identify unit-specific factors that influence access to renal transplantation. A health economic analysis will explore costs and outcomes associated with alternative approaches to organ allocation. The study will deliver: (1) an understanding of patient and unit-specific factors influencing access to renal transplantation in the UK, informing potential changes to practices and policies to optimise outcomes and reduce intercentre variability; (2) a patient-survival probability model to standardise access to the renal transplant list and (3) an understanding of PROMs and health economic impact of kidney and kidney–pancreas transplantation to inform the development of a more sophisticated and fairer organ allocation algorithm. Ethics and dissemination The protocol has been independently peer reviewed by National Institute for Health Research (NIHR) and

  5. Reliability and Validity of Outcome Expectancy-Related Measures in Physical Education

    ERIC Educational Resources Information Center

    Gao, Zan; Liu, Yuanlong; Lodewyk, Ken; Zhang, Tao; Kosma, Maria

    2011-01-01

    The purpose of this study was to examine the reliability and validity of outcome likelihood, outcome value, and outcome expectancy using data collected from students in secondary school physical education classes. Dependent measures were examined for construct, concurrent, and predictive validity, as well as internal and temporal reliability. The…

  6. Reported Outcome Measures in Degenerative Cervical Myelopathy: A Systematic Review

    PubMed Central

    McHugh, Maire; Elgheriani, Ali; Kolias, Angelos G.; Tetreault, Lindsay A.; Hutchinson, Peter J. A.; Fehlings, Michael G.; Kotter, Mark R. N.

    2016-01-01

    Objective Degenerative cervical myelopathy [DCM] is a disabling and increasingly prevalent group of diseases. Heterogeneous reporting of trial outcomes limits effective inter-study comparison and optimisation of treatment. This is recognised in many fields of healthcare research. The present study aims to assess the heterogeneity of outcome reporting in DCM as the premise for the development of a standardised reporting set. Methods A systematic review of MEDLINE and EMBASE databases, registered with PROSPERO (CRD42015025497) was conducted in accordance with PRISMA guidelines. Full text articles in English, with >50 patients (prospective) or >200 patients (retrospective), reporting outcomes of DCM were eligible. Results 108 studies, assessing 23,876 patients, conducted world-wide, were identified. Reported outcome themes included function (reported by 97, 90% of studies), complications (reported by 56, 52% of studies), quality of life (reported by 31, 29% of studies), pain (reported by 29, 27% of studies) and imaging (reported by 59, 55% of studies). Only 7 (6%) studies considered all of domains in a single publication. All domains showed variability in reporting. Conclusions Significant heterogeneity exists in the reporting of outcomes in DCM. The development of a consensus minimum dataset will facilitate future research synthesis. PMID:27482710

  7. A primer on lower extremity outcome measurement instruments.

    PubMed Central

    Saltzman, C. L.; Mueller, C.; Zwior-Maron, K.; Hoffman, R. D.

    1998-01-01

    Tracing the roots of lower extremity outcome scales is an interesting and somewhat bemusing journey. A large number of different grading methods can be found with limited reliability and/or validity testing. The usefulness of these instruments in the assessment of patient outcomes after lower extremity interventions is worrisome. This article focuses on the most commonly used scales and demonstrates an alarming and incestuous pattern of cross-validation with moderate to weak associations between potentially unreliable and crudely validated original instruments. PMID:9807715

  8. Connecting Stuttering Management and Measurement: V. Deduction and Induction in the Development of Stuttering Treatment Outcome Measures and Stuttering Treatments

    ERIC Educational Resources Information Center

    Onslow, Mark

    2006-01-01

    Background: The development of evidence-based practice, which is increasingly popular in stuttering treatment, is closely linked to the development of outcome measures. Aims: Two approaches to the development of stuttering treatment outcome measures are outlined. The first is the deductive, top-down approach, where the development of specific…

  9. A Preliminary Examination of a General Social Outcome Measure

    ERIC Educational Resources Information Center

    Stichter, Janine Peck; Herzog, Melissa J.; O'Connor, Karen V.; Schmidt, Carla

    2012-01-01

    Individuals with Pervasive Developmental Disorders (PDD) have social competence impairments that can result in negative adult outcomes. Despite considerable research on social skills training, little is available to evaluate these programs. This study describes the development, administration, and utility of a progress-monitoring tool for…

  10. Creating an Assistive Technology Outcomes Measurement System: Validating the Components

    ERIC Educational Resources Information Center

    Edyburn, Dave L.; Smith, Roger O.

    2004-01-01

    The topic of assistive technology (AT) outcomes has only recently received attention in the professional literature. As a result, there is a considerable void in the profession's ability to address contemporary questions about the value and use of AT. The purpose of this article is to highlight the theory, development, and research efforts of the…

  11. Measuring Student Satisfaction from the Student Outcomes Survey. Technical Paper

    ERIC Educational Resources Information Center

    Fieger, Peter

    2012-01-01

    The Student Outcomes Survey is an annual national survey of vocational education and training (VET) students. Since 1995, participants have been asked to rate their satisfaction with different aspects of their training, grouped under three main themes: teaching, assessment, and generic skills and learning experiences. While the composition of the…

  12. PERFORMANCE METRICS: AN OVERVIEW OF ECOLOGICAL "OUTCOME" MEASUREMENT AT EPA

    EPA Science Inventory

    The terms "Accountability" and "Outcome" are becoming ubiquitous in government agencies. The impetus for demonstrating results from government-sponsored research and regulation comes from Congress (e.g., statutes like the Government Performance Results Act of 1993 and reports fro...

  13. Developing a patient-centered outcome measure for complementary and alternative medicine therapies I: defining content and format

    PubMed Central

    2011-01-01

    Background Patients receiving complementary and alternative medicine (CAM) therapies often report shifts in well-being that go beyond resolution of the original presenting symptoms. We undertook a research program to develop and evaluate a patient-centered outcome measure to assess the multidimensional impacts of CAM therapies, utilizing a novel mixed methods approach that relied upon techniques from the fields of anthropology and psychometrics. This tool would have broad applicability, both for CAM practitioners to measure shifts in patients' states following treatments, and conventional clinical trial researchers needing validated outcome measures. The US Food and Drug Administration has highlighted the importance of valid and reliable measurement of patient-reported outcomes in the evaluation of conventional medical products. Here we describe Phase I of our research program, the iterative process of content identification, item development and refinement, and response format selection. Cognitive interviews and psychometric evaluation are reported separately. Methods From a database of patient interviews (n = 177) from six diverse CAM studies, 150 interviews were identified for secondary analysis in which individuals spontaneously discussed unexpected changes associated with CAM. Using ATLAS.ti, we identified common themes and language to inform questionnaire item content and wording. Respondents' language was often richly textured, but item development required a stripping down of language to extract essential meaning and minimize potential comprehension barriers across populations. Through an evocative card sort interview process, we identified those items most widely applicable and covering standard psychometric domains. We developed, pilot-tested, and refined the format, yielding a questionnaire for cognitive interviews and psychometric evaluation. Results The resulting questionnaire contained 18 items, in visual analog scale format, in which each line was

  14. Improving care for depression: performance measures, outcomes and insights from the Health Disparities Collaboratives.

    PubMed

    Cole, Steven; Reims, Kathy; Kershner, Liz; McCombs, Harriet G; Little, Kevin; Ford, Daniel E

    2012-08-01

    This paper reports 10 measures, outcomes, and insights from HRSA Depression Health Disparities Collaboratives, representing attempts to accelerate evidence-based guidelines into practice. The authors analyze interviews with leadership of high-performing centers. Monthly data was submitted on 38,000 patients from 94 centers. Regression analyses were conducted to identify process measures predictive of better outcomes. Results indicated that these 10 measures of care were effective in guiding and quantifying improved outcomes. One measure, early and sustained response (ESR), proved particularly useful as it reflects long term outcomes. Regression analyses identified one process measure (Patient Health Questionnaire Reassessment) strongly associated with improved clinical outcomes (n=37, R2=44%). Interviews identified 18 process changes deemed pivotal for meaningful change. In sum, well-designed approaches utilizing proven improvement methodologies resulted in substantial enhancements in depression care. This approach and these measures, especially ESR and PHQ Reassessment, may improve depression care in other under-served settings.

  15. Possible clinical outcome measures for clinical trials in patients with multiple sclerosis

    PubMed Central

    Goldman, Myla D.; Motl, Robert W.; Rudick, Richard A.

    2010-01-01

    Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease with both clinical and pathological heterogeneity. The complexity of the MS population has offered challenges to the measurement of MS disease progression in therapeutic trials. The current standard clinical outcome measures are relapse rate, Expanded Disability Severity Scale (EDSS), and the MS Functional Composite (MSFC). These measures each have strengths and some weakness. Two additional measures, the six-minute walk and accelerometry, show promise in augmenting current measures. MS therapeutics is a quickly advancing field which requires sensitive clinical outcome measures that can detect small changes in disability that reliably reflect long-term changes in sustained disease progression in a complex population. A single clinical outcome measure of sustained disease progression may remain elusive. Rather, an integration of current and new outcome measures may be most appropriate and utilization of different measures depending on the MS population and stage of the disease may be preferred. PMID:21179614

  16. Nonprofit Organizations and Outcome Measurement: From Tracking Program Activities to Focusing on Frontline Work

    ERIC Educational Resources Information Center

    Benjamin, Lehn M.

    2012-01-01

    Why do we continue to see evidence that nonprofit staff feel like outcome measurement is missing important aspects of their work? Based on an analysis of over 1,000 pages of material in 10 outcome measurement guides and a focused literature review of frontline work in three types of nonprofit organizations, this article shows that existing outcome…

  17. Measures for the Final Common Core of Constructs. The Project on State-Level Child Outcomes.

    ERIC Educational Resources Information Center

    Child Trends, Inc., Washington, DC.

    The Project on State-Level Child Outcomes, a federal project designed to improve the measurement of child outcomes in state welfare evaluations and in other state data systems. This document provides measures for the common core of constructs that state representatives developed at the second national-level meeting of the Project's planning phase.…

  18. RESNA Resource Guide for Assistive Technology Outcomes: Measurement Tools. Volume I.

    ERIC Educational Resources Information Center

    RESNA: Association for the Advancement of Rehabilitation Technology, Arlington, VA.

    This resource guide, the first of three volumes, lays out the fundamentals of outcome measurements for assistive technology. It includes the whys and hows of gathering data so that assistive technology practitioners can integrate outcomes measurement activities in their daily practice. Chapters include: (1) "Concepts and Rationale for…

  19. Predicting Student Outcome Measures Using the ASCA National Model Program Audit

    ERIC Educational Resources Information Center

    Palmer, Lauren E.; Erford, Bradley T.

    2012-01-01

    This study explored the prediction of student outcome variables from the ASCA national model level of program implementation. A total sampling of schools from two suburban school districts was conducted. Outcome variables were measures of math and reading achievement scores, attendance and graduation rates. Such measures play a central role in…

  20. Working Memory and the Observed Effectiveness of Recasts on Different L2 Outcome Measures

    ERIC Educational Resources Information Center

    Revesz, Andrea

    2012-01-01

    This study examined whether the observed effectiveness of recasts is influenced by the type of outcome measure used and whether different aspects of working memory are differentially associated with learners' performance on the various outcome measures. The participants were 90 learners of English as a foreign language, who were randomly assigned…

  1. Predicting stroke outcome using DCE-CT measured blood velocity

    NASA Astrophysics Data System (ADS)

    Oosterbroek, Jaap; Bennink, Edwin; Dankbaar, Jan Willem; Horsch, Alexander D.; Viergever, Max A.; Velthuis, Birgitta K.; de Jong, Hugo W. A. M.

    2015-03-01

    CT plays an important role in the diagnosis of acute stroke patients. Dynamic contrast enhanced CT (DCE-CT) can estimate local tissue perfusion and extent of ischemia. However, hemodynamic information of the large intracranial vessels may also be obtained from DCE-CT data and may contain valuable diagnostic information. We describe a novel method to estimate intravascular blood velocity (IBV) in large cerebral vessels using DCE-CT data, which may be useful to help predict stroke outcome. DCE-CT scans from 34 patients with isolated M1 occlusions were included from a large prospective multi-center cohort study of patients with acute ischemic stroke. Gaussians fitted to the intravascular data yielded the time-to-peak (TTP) and cerebral-blood-volume (CBV). IBV was computed by taking the inverse of the TTP gradient magnitude. Voxels with a CBV of at least 10% of the CBV found in the arterial input function were considered part of a vessel. Mid-sagittal planes were drawn manually and averages of the IBV over all vessel-voxels (arterial and venous) were computed for each hemisphere. Mean-hemisphere IBV differences, mean-hemisphere TTP differences, and hemisphere vessel volume differences were used to differentiate between patients with good and bad outcome (modified Rankin Scale score <3 versus ≥3 at 90 days) using ROC analysis. AUCs from the ROC for IBV, TTP, and vessel volume were 0.80, 0.67 and 0.62 respectively. In conclusion, IBV was found to be a better predictor of patient outcome than the parameters used to compute it and may be a promising new parameter for stroke outcome prediction.