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Sample records for patient-reported outcomes measurement

  1. Patient reported outcome measures in neurogenic bladder

    PubMed Central

    Clark, Roderick

    2016-01-01

    Many interventions for neurogenic bladder patients are directed towards improving quality of life (QOL). Patient reported outcome measures (PROMs) are the primary method of evaluating QOL, and they provide an important quantification of symptoms which can’t be measured objectively. Our goal was to review general measurement principles, and identify and discuss PROMs relevant to neurogenic bladder patients. We identify two recent reviews of the state of the literature and updated the results with an additional Medline search up to September 1, 2015. Using the previous identified reviews, and our updated literature review, we identified 16 PROMs which are used for the assessment of QOL and symptoms in neurogenic bladder patients. Several are specifically designed for neurogenic bladder patients, such as the Qualiveen (for neurogenic bladder related QOL), and the Neurogenic Bladder Symptom Score (NBSS) (for neurogenic bladder symptoms). We also highlight general QOL measures for patients with multiple sclerosis (MS) and spinal cord injury (SCI) which include questions about bladder symptoms, and incontinence PROMs which are commonly used, but not specifically designed for neurogenic bladder patients. It is essential for clinicians and researchers with an interest in neurogenic bladder to be aware of the current PROMs, and to have a basic understanding of the principals of measurement in order to select the most appropriate one for their purpose. PMID:26904409

  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.

  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 in arthroplasty registries.

    PubMed

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

    2016-07-01

    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).

  5. Patient-Reported Outcome Measures for Hand and Wrist Trauma

    PubMed Central

    Dacombe, Peter Jonathan; Amirfeyz, Rouin; Davis, Tim

    2016-01-01

    Background: Patient-reported outcome measures (PROMs) are important tools for assessing outcomes following injuries to the hand and wrist. Many commonly used PROMs have no evidence of reliability, validity, and responsiveness in a hand and wrist trauma population. This systematic review examines the PROMs used in the assessment of hand and wrist trauma patients, and the evidence for reliability, validity, and responsiveness of each measure in this population. Methods: A systematic review of Pubmed, Medline, and CINAHL searching for randomized controlled trials of patients with traumatic injuries to the hand and wrist was carried out to identify the PROMs. For each identified PROM, evidence of reliability, validity, and responsiveness was identified using a further systematic review of the Pubmed, Medline, CINAHL, and reverse citation trail audit procedure. Results: The PROM used most often was the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire; the Patient-Rated Wrist Evaluation (PRWE), Gartland and Werley score, Michigan Hand Outcomes score, Mayo Wrist Score, and Short Form 36 were also commonly used. Only the DASH and PRWE have evidence of reliability, validity, and responsiveness in patients with traumatic injuries to the hand and wrist; other measures either have incomplete evidence or evidence gathered in a nontraumatic population. Conclusions: The DASH and PRWE both have evidence of reliability, validity, and responsiveness in a hand and wrist trauma population. Other PROMs used to assess hand and wrist trauma patients do not. This should be considered when selecting a PROM for patients with traumatic hand and wrist pathology. PMID:27418884

  6. The Patient-Reported Outcomes Measurement Information System (PROMIS)

    PubMed Central

    Cella, David; Yount, Susan; Rothrock, Nan; Gershon, Richard; Cook, Karon; Reeve, Bryce; Ader, Deborah; Fries, James F.; Bruce, Bonnie; Rose, Mattias

    2010-01-01

    Background The National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Roadmap initiative (www.nihpromis.org) is a 5-year cooperative group program of research designed to develop, validate, and standardize item banks to measure patient-reported outcomes (PROs) relevant across common medical conditions. In this article, we will summarize the organization and scientific activity of the PROMIS network during its first 2 years. Design The network consists of 6 primary research sites (PRSs), a statistical coordinating center (SCC), and NIH research scientists. Governed by a steering committee, the network is organized into functional subcommittees and working groups. In the first year, we created an item library and activated 3 interacting protocols: Domain Mapping, Archival Data Analysis, and Qualitative Item Review (QIR). In the second year, we developed and initiated testing of item banks covering 5 broad domains of self-reported health. Results The domain mapping process is built on the World Health Organization (WHO) framework of physical, mental, and social health. From this framework, pain, fatigue, emotional distress, physical functioning, social role participation, and global health perceptions were selected for the first wave of testing. Item response theory (IRT)-based analysis of 11 large datasets supplemented and informed item-level qualitative review of nearly 7000 items from available PRO measures in the item library. Items were selected for rewriting or creation with further detailed review before the first round of testing in the general population and target patient populations. Conclusions The NIH PROMIS network derived a consensus-based framework for self-reported health, systematically reviewed available instruments and datasets that address the initial PROMIS domains. Qualitative item research led to the first wave of network testing which began in the second year. PMID:17443116

  7. 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

  8. Patient-reported outcome measures for asthma: a systematic review

    PubMed Central

    Worth, Allison; Hammersley, Victoria; Knibb, Rebecca; Flokstra-de-Blok, Bertine; DunnGalvin, Audrey; Walker, Samantha; Dubois, Anthony E J; Sheikh, Aziz

    2014-01-01

    Background: Patient-reported outcome measures (PROMs) are measures of the outcome of treatment(s) reported directly by the patient or carer. There is increasing international policy interest in using these to assess the impact of clinical care. Aims: To identify suitably validated PROMs for asthma and examine their potential for use in clinical settings. Methods: We systematically searched MEDLINE, EMBASE and Web of Science databases from 1990 onwards to identify PROMs for asthma. These were critically appraised, then narratively synthesised. We also identified the generic PROMs commonly used alongside asthma-specific PROMs. Results: We identified 68 PROMs for asthma, 13 of which were selected through screening as being adequately developed to warrant full-quality appraisal: 8 for adults, 4 for children and 1 for a child’s caregiver. The PROMs found to be sufficiently well validated to offer promise for use in clinical settings were the Asthma Quality of Life Questionnaire (AQLQ) and mini-AQLQ for adults, and Pediatric Asthma Quality of Life Questionnaire for children. Rhinasthma was considered promising in simultaneously assessing the impact of asthma and rhinitis in those with coexistent disease. We identified 28 generic PROMs commonly used in conjunction with asthma-specific instruments. Conclusions: We identified asthma PROMs that offer the greatest potential for use in clinical settings. Further work is needed to assess whether these are fit-for-purpose for use in clinical practice with individual patients. In particular, there is a need to ensure these are validated for use in clinical settings, acceptable to patients, caregivers and clinicians, and yield meaningful outcomes. PMID:24964767

  9. 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

  10. Assessing patient reported outcome measures: A practical guide for gastroenterologists

    PubMed Central

    Hutchings, Hayley A; Williams, John G

    2014-01-01

    Gastrointestinal illnesses cause physical, emotional and social impact on patients. Patient reported outcome measures (PROMs) are increasingly used in clinical decision-making, clinical research and approval of new therapies. In the last decade, there has been a rapid increase in the number of PROMs in gastroenterology and, therefore, the choice between which of these PROMs to use can be difficult. Not all PROM instruments currently used in research and clinical practice in gastroenterology have gone through a rigorous development methodology. New drugs and therapies will not have access to the market if the PROMs used in their clinical trials are not validated according to the guidelines of the international agencies. Therefore, it is important to know the required properties of PROMs when choosing or evaluating a drug or a clinical intervention. This paper reviews the current literature on how to assess the validity and reliability of PROMs. It summarises the required properties into a practical guide for gastroenterologists to use in assessing an instrument for use in clinical practice or research. PMID:25452841

  11. Patient-Reported Outcomes Measurement Information System Tools for Collecting Patient-Reported Outcomes in Children With Juvenile Arthritis.

    PubMed

    Brandon, Timothy G; Becker, Brandon D; Bevans, Katherine B; Weiss, Pamela F

    2017-03-01

    To evaluate the precision and construct validity of pediatric Patient-Reported Outcomes Measurement Information System (PROMIS) instruments in a population of juvenile idiopathic arthritis (JIA) patients and parent proxies. A convenience sample of JIA patients and parents of JIA patients completed PROMIS instruments for 8 domains: anger, anxiety, depressive symptoms, fatigue, mobility, pain interference, peer relationships, and upper-extremity function. Short form and computerized adaptive test (CAT) scores were derived from item bank responses. Raw scores were translated to standardized T scores with corresponding SEs. Discrimination between inactive versus active disease was evaluated as an indicator of each measure's construct validity. SEs were plotted to evaluate each instrument's relative precision. Patient-parent concordance was assessed using intraclass correlations (ICCs). A total of 228 patients and 223 parents participated, providing 71-78 responses per domain. Patient- and parent-reported anger, fatigue, mobility, and pain interference scores significantly differed between those with inactive and active disease. Anxiety, depressive symptoms, and peer relationships differed by disease activity levels for parent-report only. Short forms and CATs provided comparable reliability to the full item banks across the full range of each outcome. Patient-parent agreement ranged from ICC 0.3 to 0.8. CATs did not reduce the number of items for any domain compared to the short form. Precision and discriminatory abilities of PROMIS instruments depend on health domain and report type (self-report versus parent proxy-report) for children with JIA. Varying levels of patient-parent concordance reinforces the importance of considering both perspectives in comprehensive health outcomes assessments. © 2016, American College of Rheumatology.

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

    PubMed

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

    2014-12-01

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

  13. Patient Reported Outcomes Measurement Information System (PROMIS) in the upper extremity: the future of outcomes reporting?

    PubMed

    Makhni, Eric C; Meadows, Molly; Hamamoto, Jason T; Higgins, John D; Romeo, Anthony A; Verma, Nikhil N

    2017-02-01

    Patient reported outcomes (PROs) serve an integral role in clinical research by helping to determine the impact of clinical care as experienced by the patient. With recent initiatives in health care policy and pay for performance, outcome reporting is now recognized as a policy-driven requirement in addition to a clinical research tool. For outcome measures to satisfy these regulatory requirements and provide value in understanding disease outcomes, they must be responsive and efficient. Recent research has uncovered certain concerns regarding traditional PROs in patients with upper extremity disability and injury. These include lack of consensus regarding selection of PROs for a given diagnoses, inconsistent techniques of administration of the same PROs, and the administrative burden to patients and providers of completing these forms. To address these limitations, emphasis has been placed on streamlining the outcomes reporting process, and, as a result, the National Institutes of Health (NIH) created the Patient Reported Outcomes Measurement Information System (PROMIS). PROMIS forms were created to comprehensively and efficiently measure outcomes across multiple disease states, including orthopedics. These tools exist in computer adaptive testing and short forms with the intention of more efficiently measuring outcomes compared with legacy PROs. The goals of this review are to highlight the main components of PROMIS reporting tools and identify recent use of the scores in the upper extremity literature. The review will also highlight the research and health policy potentials and limitations of implementing PROMIS into everyday orthopedic practice. Copyright © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

  14. Meaningful health outcomes for paediatric neurodisability: Stakeholder prioritisation and appropriateness of patient reported outcome measures.

    PubMed

    Morris, Christopher; Janssens, Astrid; Shilling, Valerie; Allard, Amanda; Fellowes, Andrew; Tomlinson, Richard; Williams, Jane; Thompson Coon, Jo; Rogers, Morwenna; Beresford, Bryony; Green, Colin; Jenkinson, Crispin; Tennant, Alan; Logan, Stuart

    2015-06-25

    Health services are increasingly focused on measuring and monitoring outcomes, particularly those that reflect patients' priorities. To be meaningful, outcomes measured should be valued by patients and carers, be consistent with what health professionals seek to achieve, and be robust in terms of measurement properties. The aim of this study was (i) to seek a shared vision between families and clinicians regarding key aspects of health as outcomes, beyond mortality and morbidity, for children with neurodisability, and (ii) to appraise which multidimensional patient reported outcome measures (PROMs) could be used to assess salient health domains. Relevant outcomes were identified from (i) qualitative research with children and young people with neurodisability and parent carers, (ii) Delphi survey with health professionals, and (iii) systematic review of PROMs. The International Classification of Functioning Disability and Health provided a common language to code aspects of health. A subset of stakeholders participated in a prioritisation meeting incorporating a Q-sorting task to discuss and rank aspects of health. A total of 33 pertinent aspects of health were identified. Fifteen stakeholders from the qualitative and Delphi studies participated in the prioritisation meeting: 3 young people, 5 parent carers, and 7 health professionals. Aspects of health that emerged as more important for families and targets for health professionals were: communication, emotional wellbeing, pain, sleep, mobility, self-care, independence, mental health, community and social life, behaviour, toileting and safety. Whilst available PROMs measure many aspects of health in the ICF, no single PROM captures all the key domains prioritised as for children and young people with neurodisability. The paucity of scales for assessing communication was notable. We propose a core suite of key outcome domains for children with neurodisability that could be used in evaluative research, audit and as

  15. Single-joint outcome measures: preliminary validation of patient-reported outcomes and physical examination.

    PubMed

    Heald, Alison E; Fudman, Edward J; Anklesaria, Pervin; Mease, Philip J

    2010-05-01

    To assess the validity, responsiveness, and reliability of single-joint outcome measures for determining target joint (TJ) response in patients with inflammatory arthritis. Patient-reported outcomes (PRO), consisting of responses to single questions about TJ global status on a 100-mm visual analog scale (VAS; TJ global score), function on a 100-mm VAS (TJ function score), and pain on a 5-point Likert scale (TJ pain score) were piloted in 66 inflammatory arthritis subjects in a phase 1/2 clinical study of an intraarticular gene transfer agent and compared to physical examination measures (TJ swelling, TJ tenderness) and validated function questionnaires (Disabilities of the Arm, Shoulder and Hand scale, Rheumatoid Arthritis Outcome Score, and the Health Assessment Questionnaire). Construct validity was assessed by evaluating the correlation between the single-joint outcome measures and validated function questionnaires using Spearman's rank correlation. Responsiveness or sensitivity to change was assessed through calculating effect size and standardized response means (SRM). Reliability of physical examination measures was assessed by determining interobserver agreement. The single-joint PRO were highly correlated with each other and correlated well with validated functional measures. The TJ global score exhibited modest effect size and modest SRM that correlated well with the patient's assessment of response on a 100-mm VAS. Physical examination measures exhibited high interrater reliability, but correlated less well with validated functional measures and the patient's assessment of response. Single-joint PRO, particularly the TJ global score, are simple to administer and demonstrate construct validity and responsiveness in patients with inflammatory arthritis. (ClinicalTrials.gov identifier NCT00126724).

  16. Voice-Related Patient-Reported Outcome Measures: A Systematic Review of Instrument Development and Validation

    ERIC Educational Resources Information Center

    Francis, David O.; Daniero, James J.; Hovis, Kristen L.; Sathe, Nila; Jacobson, Barbara; Penson, David F.; Feurer, Irene D.; McPheeters, Melissa L.

    2017-01-01

    Purpose: The purpose of this study was to perform a comprehensive systematic review of the literature on voice-related patient-reported outcome (PRO) measures in adults and to evaluate each instrument for the presence of important measurement properties. Method: MEDLINE, the Cumulative Index of Nursing and Allied Health Literature, and the Health…

  17. Voice-Related Patient-Reported Outcome Measures: A Systematic Review of Instrument Development and Validation

    ERIC Educational Resources Information Center

    Francis, David O.; Daniero, James J.; Hovis, Kristen L.; Sathe, Nila; Jacobson, Barbara; Penson, David F.; Feurer, Irene D.; McPheeters, Melissa L.

    2017-01-01

    Purpose: The purpose of this study was to perform a comprehensive systematic review of the literature on voice-related patient-reported outcome (PRO) measures in adults and to evaluate each instrument for the presence of important measurement properties. Method: MEDLINE, the Cumulative Index of Nursing and Allied Health Literature, and the Health…

  18. Measure once, cut twice--adding patient-reported outcome measures to the electronic health record for comparative effectiveness research.

    PubMed

    Wu, Albert W; Kharrazi, Hadi; Boulware, L Ebony; Snyder, Claire F

    2013-08-01

    This article presents the current state of patient-reported outcome measures and explains new opportunities for leveraging the recent adoption of electronic health records to expand the application of patient-reported outcomes in both clinical care and comparative effectiveness research. Historic developments of patient-reported outcome, electronic health record, and comparative effectiveness research are analyzed in two dimensions: patient centeredness and digitization. We pose the question, "What needs to be standardized around the collection of patient-reported outcomes in electronic health records for comparative effectiveness research?" We identified three converging trends: the progression of patient-reported outcomes toward greater patient centeredness and electronic adaptation; the evolution of electronic health records into personalized and fully digitized solutions; and the shift toward patient-oriented comparative effectiveness research. Related to this convergence, we propose an architecture for patient-reported outcome standardization that could serve as a first step toward a more comprehensive integration of patient-reported outcomes with electronic health record for both practice and research. The science of patient-reported outcome measurement has matured sufficiently to be integrated routinely into electronic health records and other electronic health solutions to collect data on an ongoing basis for clinical care and comparative effectiveness research. Further efforts and ideally coordinated efforts from various stakeholders are needed to refine the details of the proposed framework for standardization. Copyright © 2013 Elsevier Inc. All rights reserved.

  19. 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

  20. Patient-reported outcome measures in burning mouth syndrome - a review of the literature.

    PubMed

    Ni Riordain, R; McCreary, C

    2013-04-01

    Oral Diseases (2013) 19, 230-235 This review aims to investigate the patient-reported outcomes currently used in the burning mouth syndrome literature and to explore whether any standardisation of such measures has taken place. Electronic databases were searched for all types of burning mouth syndrome studies using patient-reported outcome measures. Studies were selected by predefined inclusion criteria. Copies of the papers obtained were thoroughly reviewed. A study-specific data extraction form was used, allowing papers to be reviewed in a standardised manner. The initial literature search yielded a total of 173 citations, 43 of which were deemed suitable for inclusion in this study. Symptom severity and symptomatic relief were reported as a patient-reported outcome measure in 40 of the studies and quantified most commonly using a visual analogue scale. Quality of life was reported in 13 studies included in this review. Depression and/or anxiety was reported in 14 of the studies. As is evident from the variety of questionnaires and instruments used in the evaluation of the impact of burning mouth syndrome on patients' lives, no standardisation of patient outcomes has yet been achieved.

  1. Systematic review of patient-reported outcome measures for functional performance in the lower limb.

    PubMed

    Ashford, Stephen; Brown, Susan; Turner-Stokes, Lynne

    2015-01-01

    To identify psychometrically evaluated patient-reported outcome measures reflective of 'real-life' function (active and passive) for application following focal rehabilitation interventions in the lower limb after stroke or brain injury. A literature search conducted in MEDLINE, CINAHL, Embase, Web of Science, PubMed, National Health Service National Research Register, MRC Clinical Trials directory, Database of Abstracts of Reviews of Effects (DARE), Google Scholar and the Cochrane Database of Systematic Reviews. Interventional study designs using patient-reported outcome measures for outcome evaluation meeting the review objective. Evaluation of the psychometric properties used the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) process, by two independent reviewers reaching consensus, with adjudication by a third reviewer. One-hundred and thirteen studies were identified following initial review of the abstracts, yielding 12 outcome measures. Eight measures were identified, which were relevant to real life functional performance. These were the Brain Injury Community Rehabilitation Outcome, Climbing Stairs Questionnaire, Human Activity Profile, Lower Extremity Functional Scale, Nottingham Extended ADL Index, Rivermead Mobility Index (RMI), Sickness Impact Profile, Stroke Impact Scale. All measures addressed active function, with none evaluating passive function. The RMI met most psychometric criteria, but may have a ceiling effect for high functioning patients.

  2. 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.

  3. Longitudinal evaluation of Patient Reported Outcomes Measurement Information Systems (PROMIS) measures in pediatric chronic pain

    PubMed Central

    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

    2015-01-01

    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 seven 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. PROMIS measures were administered at the initial visit and two follow-up visits at an outpatient chronic pain clinic (CPC; N=82) and at an intensive amplified pain day-treatment program (AMP; 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 AMP 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 seven 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. PMID:26447704

  4. Challenges and Opportunities in Using Patient-reported Outcomes in Quality Measurement in Rheumatology.

    PubMed

    Wahl, Elizabeth R; Yazdany, Jinoos

    2016-05-01

    Use of patient-reported outcome measures (PROs) in rheumatology research is widespread, but use of PRO data to evaluate the quality of rheumatologic care delivered is less well established. This article reviews the use of PROs in assessing health care quality, and highlights challenges and opportunities specific to their use in rheumatology quality measurement. It first explores other countries' experiences collecting and evaluating national PRO data to assess quality of care. It describes the current use of PROs as quality measures in rheumatology, and frames an agenda for future work supporting development of meaningful quality measures based on PROs.

  5. Challenges and Opportunities in Using Patient-Reported Outcomes in Quality Measurement in Rheumatology

    PubMed Central

    Wahl, Elizabeth; Yazdany, Jinoos

    2016-01-01

    Summary Use of Patient-reported outcome measures (PROs) in rheumatology research is widespread, but use of PRO data to evaluate the quality of rheumatologic care delivered is less well established. This article reviews the use of PROs in assessing healthcare quality, and highlights challenges and opportunities specific to their use in rheumatology quality measurement. We first explore other countries’ experiences collecting and evaluating national PRO data to assess quality of care. We describe the current use of PROs as quality measures in rheumatology, and frame an agenda for future work supporting development of meaningful quality measures based on PROs. PMID:27133495

  6. Methods for Developing Patient-Reported Outcome-Based Performance Measures (PRO-PMs).

    PubMed

    Basch, Ethan; Spertus, John; Dudley, R Adams; Wu, Albert; Chuahan, Cynthia; Cohen, Perry; Smith, Mary Lou; Black, Nick; Crawford, Amaris; Christensen, Keri; Blake, Kathleen; Goertz, Christine

    2015-06-01

    To recommend methods for assessing quality of care via patient-reported outcome-based performance measures (PRO-PMs) of symptoms, functional status, and quality of life. A Technical Expert Panel was assembled by the American Medical Association-convened Physician Consortium for Performance Improvement. An environmental scan and structured literature review were conducted to identify quality programs that integrate PRO-PMs. Key methodological considerations in the design, implementation, and analysis of these PRO-PM data were systematically identified. Recommended methods for addressing each identified consideration were developed on the basis of published patient-reported outcome (PRO) standards and refined through public comment. Literature review focused on programs using PROs to assess performance and on PRO guidance documents. Thirteen PRO programs and 10 guidance documents were identified. Nine best practices were developed, including the following: provide a rationale for measuring the outcome and for using a PRO-PM; describe the context of use; select a measure that is meaningful to patients with adequate psychometric properties; provide evidence of the measure's sensitivity to differences in care; address missing data and risk adjustment; and provide a framework for implementation, interpretation, dissemination, and continuous refinement. Methods for integrating PROs into performance measurement are available. Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  7. Patient reported outcomes measures in neurogenic bladder and bowel: A systematic review of the current literature.

    PubMed

    Patel, Darshan P; Elliott, Sean P; Stoffel, John T; Brant, William O; Hotaling, James M; Myers, Jeremy B

    2016-01-01

    To describe existing bladder and bowel specific quality of life (QoL) measurement tools, QoL in patients with multiple sclerosis (MS), spinal cord injury (SCI), Parkinson's Disease (PD), stroke, or spina bifida (SB) affected by bladder or bowel dysfunction, and the impact of specific bladder and bowel management on QoL. We performed a systematic review in PubMed/Medline databases in accordance with the PRISMA statement for English publications between January 1, 2000 and January 1, 2014. Articles were first screened based on their abstract and select full-text articles were then reviewed for eligibility. Articles with no QoL or PROM assessing urinary or bowel dysfunction were excluded. Risk of bias assessment included randomization, incomplete outcomes data, selective outcomes reporting, and other biases. All articles were graded using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system as per the Cochrane Handbook for Systematic Reviews of Interventions. The most common QoL measurement tool for urinary and bowel dysfunction was the Medical Outcomes Study SF-36. Twelve (24%) studies used only non-validated QoL questionnaires. Only three urinary or bowel specific QoL measures were found: the Qualiveen questionnaire, the FICQoL, and the QoL-BM. Several studies identified instances were clinical and patient-reported outcomes were inconsistent particularly with indwelling urinary catheter usage and reconstructive surgery. Additionally, certain clinical outcomes surrogates commonly used as primary outcomes measures may not correlate with the patient reported outcomes (PRO). Current PRO measures (PROM) and QoL assessments are heterogeneous and several inconsistencies in clinical and PRO for various management options exist. Standardized PROM will help identify optimal bladder and bowel management for patients with neurologic conditions. © 2014 Wiley Periodicals, Inc.

  8. 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

  9. 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.

  10. Patient-reported Outcome Measurement for Patients With Total Knee Arthroplasty.

    PubMed

    Lyman, Stephen; Yin, Kaitlyn L

    2017-02-01

    Total knee arthroplasty is a large contributor to Medicare costs. In an effort to lower costs and improve outcomes, the Centers for Medicaid and Medicare Services has implemented the Comprehensive Care for Joint Replacement model, which incentivizes surgeons to submit both general health and joint-specific patient-reported outcome measures (PROMs). However, in addition to using PROMs for reporting purposes, surgeons should also consider incorporating PROMs into clinical practice. Currently, PROMs are not widely implemented in the clinical setting despite their value in measuring factors such as patients' expectations and mental state, which impact outcomes. Furthermore, as technology improves, PROM collection will become faster and more efficient. The information collected by PROMs can inform treatment decisions and facilitate communication between the surgeon and the patient.

  11. Extending basic principles of measurement models to the design and validation of Patient Reported Outcomes.

    PubMed

    Atkinson, Mark J; Lennox, Richard D

    2006-09-22

    A recently published article by the Scientific Advisory Committee of the Medical Outcomes Trust presents guidelines for selecting and evaluating health status and health-related quality of life measures used in health outcomes research. In their article, they propose a number of validation and performance criteria with which to evaluate such self-report measures. We provide an alternate, yet complementary, perspective by extending the types of measurement models which are available to the instrument designer. During psychometric development or selection of a Patient Reported Outcome measure it is necessary to determine which, of the five types of measurement models, the measure is based on; 1) a Multiple Effect Indicator model, 2) a Multiple Cause Indicator model, 3) a Single Item Effect Indicator model, 4) a Single Item Cause Indicator model, or 5) a Mixed Multiple Indicator model. Specification of the measurement model has a major influence on decisions about item and scale design, the appropriate application of statistical validation methods, and the suitability of the resulting measure for a particular use in clinical and population-based outcomes research activities.

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

    PubMed

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

    2017-06-01

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

  13. Validation of the Vitiligo Noticeability Scale: a patient-reported outcome measure of vitiligo treatment success.

    PubMed

    Batchelor, J M; Tan, W; Tour, S; Yong, A; Montgomery, A A; Thomas, K S

    2016-02-01

    Patient-reported outcome measures are rarely used in vitiligo trials. The Vitiligo Noticeability Scale (VNS) is a new patient-reported outcome measure assessing how 'noticeable' vitiligo patches are after treatment. The noticeability of vitiligo after treatment is an important indicator of treatment success from the patient's perspective. To evaluate the construct validity, acceptability and interpretability of the VNS. Clinicians (n = 33) and patients with vitiligo (n = 101) examined 39 image pairs, each depicting a vitiligo lesion pre- and post-treatment. Using an online questionnaire, respondents gave a global assessment of treatment success and a VNS score for treatment response. Clinicians also estimated percentage repigmentation of lesions (< 25%; 25-50%; 51-75%; > 75%). Treatment success was defined as 'yes' on global assessment, a VNS score of 4 or 5, and > 75% repigmentation. Agreement between respondents and the different scales was assessed using kappa (κ) statistics. Vitiligo Noticeability Scale scores were associated with both patient- and clinician-reported global treatment success (κ = 0·54 and κ = 0·47, respectively). Percentage repigmentation showed a weaker association with patient- and clinician-reported global treatment success (κ = 0·39 and κ = 0·29, respectively). VNS scores of 4 or 5 can be interpreted as representing treatment success. Images depicting post-treatment hyperpigmentation were less likely to be rated as successful. The VNS is a valid patient-reported measure of vitiligo treatment success. Further validation of the VNS is required, using larger sets of clinical pre- and post-treatment images, affecting a wider range of anatomical sites. © 2015 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

  14. Methods for interpreting change over time in patient-reported outcome measures.

    PubMed

    Wyrwich, K W; Norquist, J M; Lenderking, W R; Acaster, S

    2013-04-01

    Interpretation guidelines are needed for patient-reported outcome (PRO) measures' change scores to evaluate efficacy of an intervention and to communicate PRO results to regulators, patients, physicians, and providers. The 2009 Food and Drug Administration (FDA) Guidance for Industry Patient-Reported Outcomes (PRO) Measures: Use in Medical Product Development to Support Labeling Claims (hereafter referred to as the final FDA PRO Guidance) provides some recommendations for the interpretation of change in PRO scores as evidence of treatment efficacy. This article reviews the evolution of the methods and the terminology used to describe and aid in the communication of meaningful PRO change score thresholds. Anchor- and distribution-based methods have played important roles, and the FDA has recently stressed the importance of cross-sectional patient global assessments of concept as anchor-based methods for estimation of the responder definition, which describes an individual-level treatment benefit. The final FDA PRO Guidance proposes the cumulative distribution function (CDF) of responses as a useful method to depict the effect of treatments across the study population. While CDFs serve an important role, they should not be a replacement for the careful investigation of a PRO's relevant responder definition using anchor-based methods and providing stakeholders with a relevant threshold for the interpretation of change over time.

  15. Item banking: a generational change in patient-reported outcome measurement.

    PubMed

    Pesudovs, Konrad

    2010-04-01

    Patient-reported outcomes are traditionally measured with questionnaires and many have been developed to measure Vision-Related Activity Limitation (VRAL; visual disability or visual functioning), Symptoms, and Quality Of Life (QOL). These vary in quality and can be classified as First or Second Generation instruments. First generation instruments are characterized by simple summary scoring of ordinal responses, which precludes interval measurement. This problem is solved in second generation instruments where Rasch analysis is used to optimize psychometric properties. However, second generation instruments retain limitations; difficulties in comparing scores across instruments, limited applicability to populations and inability to adapt to change. A third generation approach to patient-reported outcomes measurement, item banking, can solve these problems. The aim of this project was to use Rasch analysis to calibrate all items from all instruments to form VRAL, Symptoms, and QOL Item Banks. Six hundred twenty-four people on the waiting list for cataract surgery were recruited. Each participant completed, by self-administration, a number of the 19 instruments. A total of 353 items were calibrated using Rasch analysis (Winsteps v3.67). The psychometric properties of each item bank were optimized; items fitting the Rasch model were retained (Infit and Outfit range, 0.50 to 1.50). Items were sorted into the three traits; 226 tapped VRAL, 22 symptoms, and 60 QOL. Satisfactory measurement of each latent trait occurred with person separation of 8.11 for VRAL, 2.33 for Symptoms, and 3.20 for QOL. Rasch estimates of item difficulty were highly stable with an average standard error of 0.11 logits. Item banks for the measurement of the latent traits of VRAL, symptoms, and QOL have been formed. New items can be added to enable evolution of measurement. Item banking facilitates accurate and precise measurement through computer adaptive testing. This approach provides common

  16. Measuring patient-reported outcomes: moving beyond misplaced common sense to hard science

    PubMed Central

    2011-01-01

    Interest in the patient's views of his or her illness and treatment has increased dramatically. However, our ability to appropriately measure such issues lags far behind the level of interest and need. Too often such measurement is considered to be a simple and trivial activity that merely requires the application of common sense. However, good quality measurement of patient-reported outcomes is a complex activity requiring considerable expertise and experience. This review considers the most important issues related to such measurement in the context of chronic disease and details how instruments should be developed, validated and adapted for use in additional languages. While there is often consensus on how best to undertake these activities, there is generally little evidence to support such accord. The present article questions these orthodox views and suggests alternative approaches that have been shown to be effective. PMID:21756344

  17. When Using Patient-Reported Outcomes in Clinical Practice, the Measure Matters: A Randomized Controlled Trial

    PubMed Central

    Snyder, Claire F.; Herman, Joseph M.; White, Sharon M.; Luber, Brandon S.; Blackford, Amanda L.; Carducci, Michael A.; Wu, Albert W.

    2014-01-01

    Background: Patient-reported outcome (PRO) measures are increasingly being used in clinical practice to inform individual patient management, but evidence is needed on which PROs are best suited for clinical use. Methods: This controlled trial randomly assigned patients with breast and prostate cancer undergoing treatment to complete one of three PRO measures: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30), Supportive Care Needs Survey-Short Form (SCNS-SF34), or six domains from the Patient-Reported Outcomes Measurement Information System (PROMIS). Patients completed the PRO measures before clinic visits, and the results were provided to both the patient and clinician. At treatment completion, patients and clinicians completed brief feedback forms on the intervention's usefulness and value. Exit interviews were conducted with patients (at end of treatment) and clinicians (at end of study). The primary outcome was the proportion of patients in each arm who either strongly agreed or agreed to all feedback form items. Results: Of 294 eligible patients invited to participate, 224 (76%) enrolled (median age 66 years, 78% white, 72% prostate). Of the 181 patients (81%) who completed at least one feedback form item, participants in the QLQ-C30 study arm were most likely to strongly agree/agree to all items (74%) followed by PROMIS (61%) and SCNS-SF34 (52%; P = .03). Of the 116 participants (52%) who completed all feedback form items, the results were similar: 82% for the QLQ-C30, 62% for PROMIS, and 56% for SCNS-SF34 (P = .05). Clinicians did not prefer one questionnaire over the others. Conclusion: These results suggest that, when using PROs in clinical practice for patient management, the measure matters in terms of usefulness to patients. PMID:24986113

  18. Patient reported outcome measures of quality of end-of-life care: A systematic review.

    PubMed

    Kearns, Tara; Cornally, Nicola; Molloy, William

    2017-02-01

    End-of-life (EoL) care(1) is increasingly used as a generic term in preference to palliative care or terminal care, particularly with reference to individuals with chronic disease, who are resident in community and long-term care (LTC) settings. This review evaluates studies based on patient reported outcome measures (PROMS) of quality of EoL care across all health-care settings. From 1041 citations, 12 studies were extracted by searches conducted in EBSCO, Scopus, Web of Science, PubMed, Cochrane, Open Grey and Google Scholar databases. At present, the evidence base for EoL care is founded on cancer care. This review highlights the paucity of studies that evaluate quality of EoL care for patients with chronic disease outside the established cancer-acute care paradigm, particularly in LTC. This review highlights the absence of any PROMs for the estimated 60% of patients in LTC with cognitive impairment. Patient-reported outcomes (PROs) are critical to understanding how EoL care services and practices affect patients' health and EoL experience. PROMs describe the quality of care from the patient's perspective and add balance to existing clinical or proxy-derived knowledge on the quality of care and services provided.

  19. Modern perspectives of measurement validation emphasize justification of inferences based on patient-reported outcome scores: seventh paper in a series on patient reported outcomes.

    PubMed

    Sawatzky, Richard; Chan, Eric K H; Zumbo, Bruno D; Ahmed, Sara; Bartlett, Susan J; Bingham, Clifton O; Gardner, William; Jutai, Jeffrey; Kuspinar, Ayse; Sajobi, Tolulope; Lix, Lisa M

    2016-12-18

    Obtaining the patient's view about the outcome of care is an essential component of patient-centered care. Many patient-reported outcome (PRO) instruments for different purposes have been developed since the 1960s. Measurement validation is fundamental in the development, evaluation, and use of PRO instruments. This paper provides a review of modern perspectives of measurement validation in relation to the followings three questions as applied to PROs: (1) What evidence is needed to warrant comparisons between groups and individuals? (2) What evidence is needed to warrant comparisons over time? and (3) What are the value implications, including personal and societal consequences, of using PRO scores? Measurement validation is an ongoing process that involves the accumulation of evidence regarding the justification of inferences, actions, and decisions based on measurement scores. These include inferences pertaining to comparisons between groups and comparisons over time as well as consideration of value implications of using PRO scores. Personal and societal consequences must be examined as part of a comprehensive approach to measurement validation. The answers to these three questions are fundamental to the the validity of different types of inferences, actions, and decisions made on PRO scores in health research, health care administration, and clinical practice. Copyright © 2016 Elsevier Inc. All rights reserved.

  20. 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.

  1. Patient-Reported Outcome Measures-What Data Do We Really Need?

    PubMed

    Lyman, Stephen; Hidaka, Chisa

    2016-06-01

    The Center for Medicaid and Medicare Services has recently announced the inclusion of several patient-reported outcome measures (PROMs), including the abbreviated Hip Disability and Osteoarthritis Outcome Score and Knee Injury and Osteoarthritis Outcome Score for joint replacement (HOOS, JR and KOOS, JR) for the purpose of quality assessment in total hip and total knee replacement (THR and TKR). Historically, Center for Medicaid and Medicare Services and other agencies have used measures of process (eg, % vaccinated) or adverse events (eg, infection rates, readmission rates) for quality assessment. However, the use of PROMs has become a priority based on stated goals by the National Quality Strategy and Institute of Medicine for a more patient-centered approach. Here, we review several general health and joint-specific PROMs, which have been extensively used in research to assess treatment efficacy and discuss their relevance to the new criteria for quality assessment, particularly for THR and TKR. Although we expect HOOS, JR and KOOS, JR to yield much useful information in the near term, these surveys are likely an interim solution. In the future, we anticipate that novel measurement platforms, such as wearable technologies or patient-specific surveys, may open new and exciting avenues of research to discover which types of data-perhaps not previously available-best represent patient quality of life and satisfaction after THR, TKR, or other orthopedic procedures. Copyright © 2016 Elsevier Inc. All rights reserved.

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

    PubMed Central

    Daniero, James J.; Hovis, Kristen L.; Sathe, Nila; Jacobson, Barbara; Penson, David F.; Feurer, Irene D.; McPheeters, Melissa L.

    2017-01-01

    Purpose The purpose of this study was to perform a comprehensive systematic review of the literature on voice-related patient-reported outcome (PRO) measures in adults and to evaluate each instrument for the presence of important measurement properties. Method MEDLINE, the Cumulative Index of Nursing and Allied Health Literature, and the Health and Psychosocial Instrument databases were searched using relevant vocabulary terms and key terms related to PRO measures and voice. Inclusion and exclusion criteria were developed in consultation with an expert panel. Three independent investigators assessed study methodology using criteria developed a priori. Measurement properties were examined and entered into evidence tables. Results A total of 3,744 studies assessing voice-related constructs were identified. This list was narrowed to 32 PRO measures on the basis of predetermined inclusion and exclusion criteria. Questionnaire measurement properties varied widely. Important thematic deficiencies were apparent: (a) lack of patient involvement in the item development process, (b) lack of robust construct validity, and (c) lack of clear interpretability and scaling. Conclusions PRO measures are a principal means of evaluating treatment effectiveness in voice-related conditions. Despite their prominence, available PRO measures have disparate methodological rigor. Care must be taken to understand the psychometric and measurement properties and the applicability of PRO measures before advocating for their use in clinical or research applications. PMID:28030869

  3. Minimal Clinically Important Difference of Patient Reported Outcome Measures of Lower Extremity Injuries in Orthopedics

    PubMed Central

    Çelik, Derya; Çoban, Özge; Kılıçoğlu, Önder

    2017-01-01

    Purpose: MCID scores for outcome measures are frequently used evidence-based guides to gage meaningful changes. To conduct a systematic review of the quality and content of the the minimal clinically important difference (MCID) relating to 16 patient-rated outcome measures (PROM) used in lower extremity. Methods: We conducted a systematic literature review on articles reporting MCID in lower extremity outcome measures and orthopedics from January 1, 1980, to May 10, 2016. We evaluated MCID of the 16 patient reported outcome measures (PROM) which were Harris Hip Score (HHS), Oxford Hip Score (OHS), Hip Outcome Score (HOS), Hip Disability and Osteoarthritis Outcome Score (HOOS), The International Knee Documentation Committee Subjective Knee Form (IKDC), The Lysholm Scale, The Western Ontario Meniscal Evaluation Tool (WOMET), The Anterior Cruciate Ligament Quality of Life Questionnaire (ACL-QOL), The Lower Extremity Functional Scale (LEFS), The Western Ontario and Mcmaster Universities Index (WOMAC), Knee İnjury And Osteoarthritis Outcome Score (KOOS), Oxford Knee Score (OKS), Kujala Anterior Knee Pain Scale, The Victorian Institute of Sports Assessment Patellar Tendinosis (Jumper’s Knee) (VİSA-P), Tegner Activity Rating Scale, Marx Activity Rating Scale, Foot And Ankle Outcome Score (FAOS), The Foot Function Index (FFI), Foot And Ankle Ability Measure (FAAM), The Foot And Ankle Disability Index Score and Sports Module, Achill Tendon Total Rupture Score(ATRS), The Victorian İnstitute Of Sports Assesment Achilles Questionnaire(VİSA-A), American Orthopaedic Foot and Ankle Society (AOFAS). A search of the PubMed/MEDLINE, PEDro and Cochrane Cen¬tral Register of Controlled Trials and Web of Science databases from the date of inception to May 1, 2016 was conducted. The terms “minimal clinically important difference,” “minimal clinically important change”, “minimal clinically important improvement” “were combined with one of the PROM as mentioned above

  4. 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

  5. Systematic review: patient-reported outcome measures in coeliac disease for regulatory submissions.

    PubMed

    Canestaro, W J; Edwards, T C; Patrick, D L

    2016-08-01

    New therapeutics are moving into phase 3 clinical trials for the treatment of coeliac disease, a condition with no established therapies other than gluten-free diet. These trials will require a meaningful, validated and fit for purpose patient-reported outcome measure (PROM) to quantify the symptomatic improvement of patients. To evaluate existing PROMs for suitability in a Food and Drug Administration (FDA) approval trial for a coeliac disease therapeutic. We performed a systematic search in five online databases (MedLine, EmBase, Web of Science, CENTRAL, CINAHL) for studies that enrolled patients with coeliac disease and used PROMs. Studies included in this review had to measure some PROM concept, be patient administered and based upon a previously validated instrument with published measurement properties. Our literature search identified 2706 unique records of which 199 ultimately qualified for abstraction. The majority of PROMs used in studies of coeliac disease was generic and did not measure numerous symptoms or concerns of interest to patients. Four PROMs were found to contain appropriate content for use in an FDA trial: the coeliac disease-specific modification of the Gastrointestinal Symptoms Rating Scale (CeD-GSRS), Psychological General Well-Being Index (PGWB), the Celiac Disease Symptom Diary (CDSD) and the Celiac Disease Patient Reported Outcome (CeD-PRO). The GSRS and PGWB are most often used together and are two of the most extensively used measures in coeliac disease. The CDSD and CeD-PRO were developed exclusively for trials in coeliac disease but have much less published information on their measurement properties. While we did not find PROMs that currently meet the stated expectations of the FDA for regulatory purposes, four PROMs (CeD-GSRS, PGWB, CDSD and CeD-PRO) appear to contain appropriate content and with modest additional validation work could meet scientific standards for valid and sensitive measures of disease and treatment outcome

  6. Measuring patient-reported outcomes in facial aesthetic patients: development of the FACE-Q.

    PubMed

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

    2010-08-01

    To support the development of new techniques and technology in facial aesthetics, sophisticated ways of measuring outcomes are needed. The objective of this study was to develop the content of a set of patient-reported outcome (PRO) scales for use with facial aesthetic patients. A literature review, patient interviews, and input from experts working with facial aesthetic patients were used to develop a conceptual framework for the outcomes deemed important to facial aesthetic patients and to construct items and a set of preliminary PRO scales. The conceptual framework includes the following themes: satisfaction with facial appearance; health-related quality of life; recovery, early life impact, and adverse effects; and satisfaction with process of care. Separate scales were developed for all parts of the face (e.g., nose, ears, forehead, cheeks, etc.) rather than for particular facial procedures. This new PRO instrument, called the FACE-Q, contains multiple independently scoreable scales with preoperative and postoperative versions. Once psychometric evaluation is completed, the FACE-Q will provide researchers and physicians with the necessary tools to measure the impact and effectiveness of facial aesthetic procedures from the patients' perspective. The FACE-Q has the potential to support advocacy, quality metrics, and an evidence-based approach to facial aesthetic practice. (c) Thieme Medical Publishers.

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

    PubMed Central

    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. PMID:24013090

  8. Application of Patient-Reported Outcomes Measurement Information System to chronic pelvic pain.

    PubMed

    Fenton, Bradford W; Palmieri, Patrick; Diantonio, Gina; Vongruenigen, Vivian

    2011-01-01

    To apply the Patient-Reported Outcomes Measurement Information System (PROMIS) recently developed by the National Institutes of Health in patients with chronic pelvic pain. Secondary objectives included evaluation of individual pain categories and of the effect of the occurrence of myofascial abdominal wall and pelvic floor muscle pain. Retrospective study (Canadian Task Force classification III). Chronic pelvic pain multidisciplinary referral center. A total of 149 consecutive patients with chronic pelvic pain provided evaluable results. As part of a comprehensive evaluation, patients were assigned diagnoses based on standard criteria, and completed the 96-item short-form PROMIS. Pain-related and global PROMIS scores were significantly worse than in the reference population (p <.05). The presence of myofascial pain was also associated with worse PROMIS scores. Chronic pelvic pain is associated with impaired quality of life regardless of the diagnosis, including myofascial pain. Copyright © 2011 AAGL. Published by Elsevier Inc. All rights reserved.

  9. Development of the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptom Scales

    PubMed Central

    Spiegel, Brennan M.R.; Hays, Ron D.; Bolus, Roger; Melmed, Gil Y.; Chang, Lin; Whitman, Cynthia; Khanna, Puja P.; Paz, Sylvia H.; Hays, Tonya; Reise, Steve; Khanna, Dinesh

    2014-01-01

    OBJECTIVES The National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS®) is a standardized set of patient-reported outcomes (PROs) that cover physical, mental, and social health. The aim of this study was to develop the NIH PROMIS gastrointestinal (GI) symptom measures. METHODS We first conducted a systematic literature review to develop a broad conceptual model of GI symptoms. We complemented the review with 12 focus groups including 102 GI patients. We developed PROMIS items based on the literature and input from the focus groups followed by cognitive debriefing in 28 patients. We administered the items to diverse GI patients (irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), systemic sclerosis (SSc), and other common GI disorders) and a census-based US general population (GP) control sample. We created scales based on confirmatory factor analyses and item response theory modeling, and evaluated the scales for reliability and validity. RESULTS A total of 102 items were developed and administered to 865 patients with GI conditions and 1,177 GP participants. Factor analyses provided support for eight scales: gastroesophageal reflux (13 items), disrupted swallowing (7 items), diarrhea (5 items), bowel incontinence/soilage (4 items), nausea and vomiting (4 items), constipation (9 items), belly pain (6 items), and gas/bloat/flatulence (12 items). The scales correlated significantly with both generic and disease-targeted legacy instruments, and demonstrate evidence of reliability. CONCLUSIONS Using the NIH PROMIS framework, we developed eight GI symptom scales that can now be used for clinical care and research across the full range of GI disorders. PMID:25199473

  10. Patient-reported outcome measures in pediatric epilepsy: a content analysis using World Health Organization definitions.

    PubMed

    Sadeghi, Salva; Fayed, Nora; Ronen, Gabriel M

    2014-09-01

    Patient-reported outcome (PRO) measures that assess the effect of epilepsy on children's lives include the concepts of health, health-related quality of life (HRQOL), and quality of life (QOL). They also contain varied health and health-related content. Our objectives were to identify what generic and epilepsy-specific PRO instruments are used in childhood epilepsy research and to make explicit their conceptual approach and biopsychosocial content. MEDLINE, EMBASE, and PsycINFO were searched from 2001 to 2011 for PRO measures used in pediatric epilepsy. Measures were analyzed on an item-by-item basis according to World Health Organization (WHO) definitions of QOL and the International Classification of Functioning, Disability and Health for Children and Youth (ICF-CY) biopsychosocial health framework to distinguish the conceptual approach within each measure. The health content analysis coded each item according to specific ICF-CY components of body function, activity and participation, environment, or personal factors to determine the health content for each measure. Three generic and 13 epilepsy-specific PRO measures were identified; 10 of 16 measures utilized a biopsychosocial health approach rather than an HRQOL or QOL approach. Content analysis showed that in 11 of 16 measures, >25% of the items represented participation and activity components of the ICF-CY, whereas a high proportion of environment items were found in only one epilepsy-specific measure. This comprehensive review provides information aiding clinicians and researchers in the selection of the appropriate PRO instruments for children with epilepsy on the basis of content. Most epilepsy-specific and generic PROs use a biopsychosocial health approach as opposed to a subjective HRQOL/QOL approach to measurement. Clinicians and researchers must be aware of these concepts and content when intending to measure outcomes validly. Wiley Periodicals, Inc. © 2014 International League Against Epilepsy.

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

    PubMed

    Snowden, Austyn; Telfer, Iain

    2017-01-01

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

  12. 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

  13. Patient-reported outcomes in multiple sclerosis: a systematic comparison of available measures.

    PubMed

    Khurana, V; Sharma, H; Afroz, N; Callan, A; Medin, J

    2017-09-01

    Multiple patient-reported outcomes (PROs) are currently being used in multiple sclerosis (MS) but their application is inconsistent and guidance on the appropriateness of each tool is lacking. The objective of our study was to identify MS-specific PROs and systematically to assess the development process and the reliability and validity of various instruments. A systematic literature search was conducted on multiple data sources, including MEDLINE, Embase (using the Ovid platform) and Google Scholar, from 1996 to March 2015. Search terms included combinations of MS, PROs and quality of life. Randomized controlled trials or observational studies conducted on patients with MS and published in English were included. In addition, the PROQOLID database was explored. The MS-specific PROs were systematically assessed using the Evaluating the Measurement of Patient-Reported Outcomes tool. In total, 8094 articles were screened and 405 PROs were identified from 1102 relevant articles. PROs were classified into MS-specific (n = 82) and non-MS-specific (n = 323). The results for the eight PROs that are most commonly used in MS clinical trials are presented here. For these eight PROs, the overall summary scores ranged between 50.1 and 68.7. The Multiple Sclerosis Impact Scale-29 had the best overall mean score (68.7), followed by the Leeds Multiple Sclerosis Quality of Life (67.0). This is the first study to provide a standardized assessment of all PROs for MS. There is a lack of data on content validity for PROs used in MS research, which indicates the need for a robust instrument in MS developed according to the US Food and Drug Administration guidelines. © 2017 EAN.

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

    PubMed

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

    2016-12-01

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

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

    PubMed

    Patel, Nishant; Brown, Robert D; Sarkissian, Carl; De, Shubha; Monga, Manoj

    2017-08-08

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

  16. Using the Patient Reported Outcomes Measurement Information System to Evaluate Psychosocial Functioning among Children with Craniofacial Anomalies.

    PubMed

    Shapiro, Danielle N; Waljee, Jennifer; Ranganathan, Kavitha; Buchman, Steven; Warschausky, Seth

    2015-06-01

    Children with craniofacial anomalies are at risk for social exclusion, bullying, and psychological symptoms, all of which are associated with poor developmental and health outcomes. The National Institutes of Health-developed Patient Reported Outcomes Measurement Information System instruments may be useful tools for monitoring psychosocial functioning in clinical settings and for integrating patient and parent perspectives. The current study included 74 children (50 percent male) with craniofacial anomalies recruited through a multidisciplinary clinic. The authors obtained child self-report and parent-proxy ratings of depression, anxiety, and peer relationship quality using National Institutes of Health Patient Reported Outcomes Measurement Information System instruments. The authors compared sample means to Patient Reported Outcomes Measurement Information System instruments norms and analyzed the reliability of parents' and children's reporting of psychosocial variables. All reliability statistics were satisfactory (α values ranging from 0.74 to 0.96) and sample standard deviations were similar to those obtained in a general population, suggesting that Patient Reported Outcomes Measurement Information System instruments are reliable among children with craniofacial anomalies. In general, children and parents did not report unusual levels of psychological distress; however, they did report poorer peer relationship quality relative to normed data, a trend that was particularly pronounced among boys. National Institutes of Health Patient Reported Outcomes Measurement Information System instruments are efficient and accurate tools for monitoring psychosocial adjustment among children with craniofacial anomalies. It may be especially important to monitor social functioning, particularly among boys.

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

    PubMed

    Coco, Laura; Colina, Sonia; Atcherson, Samuel R; Marrone, Nicole

    2017-09-18

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

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

    PubMed

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

    2010-11-01

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

  19. The importance of rating scales in measuring patient-reported outcomes

    PubMed Central

    2012-01-01

    Background A critical component that influences the measurement properties of a patient-reported outcome (PRO) instrument is the rating scale. Yet, there is a lack of general consensus regarding optimal rating scale format, including aspects of question structure, the number and the labels of response categories. This study aims to explore the characteristics of rating scales that function well and those that do not, and thereby develop guidelines for formulating rating scales. Methods Seventeen existing PROs designed to measure vision-related quality of life dimensions were mailed for self-administration, in sets of 10, to patients who were on a waiting list for cataract extraction. These PROs included questions with ratings of difficulty, frequency, severity, and global ratings. Using Rasch analysis, performance of rating scales were assessed by examining hierarchical ordering (indicating categories are distinct from each other and follow a logical transition from lower to higher value), evenness (indicating relative utilization of categories), and range (indicating coverage of the attribute by the rating scale). Results The rating scales with complicated question format, a large number of response categories, or unlabelled categories, tended to be dysfunctional. Rating scales with five or fewer response categories tended to be functional. Most of the rating scales measuring difficulty performed well. The rating scales measuring frequency and severity demonstrated hierarchical ordering but the categories lacked even utilization. Conclusion Developers of PRO instruments should use a simple question format, fewer (four to five) and labelled response categories. PMID:22794788

  20. A systematic review of patient-reported outcome measures for chronic suppurative otitis media.

    PubMed

    Phillips, John S; Yung, Matthew W

    2016-06-01

    The purpose of this review was to systematically appraise the world literature to identify existing patient-reported outcome measures (PROMs) for the assessment of outcomes in patients with chronic suppurative otitis media, to verify the diversity of the individual questionnaire items, to report the methods employed to evaluate the questionnaires, and to identify areas for development in the future. Embase (January 1980-November 2014), MEDLINE (January 1946-November 2014), Cumulative Index to Nursing and Allied Health Literature (January 1981-November 2014), and PsycINFO (January 1806-November 2014). A systematic literature search was independently undertaken by the two authors according to predefined inclusion and exclusion criteria. Nine original articles were identified, which overall outlined the evaluation of four different questionnaires. This systematic appraisal of the world literature has identified four PROM questionnaires for use in patients with chronic suppurative otitis media. All four questionnaires evaluate reliability and validity using different psychometric methods. The Chronic Ear Survey questionnaire has been most broadly evaluated and disseminated. All four questionnaires assess static health status. There are many advantages to developing a dynamic one-hit questionnaire to assess the health status of patients having undergone an intervention for chronic suppurative otitis media. NA Laryngoscope, 126:1458-1463, 2016. © 2015 The American Laryngological, Rhinological and Otological Society, Inc.

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

    PubMed

    Brédart, Anne; Marrel, Alexia; Abetz-Webb, Linda; Lasch, Kathy; Acquadro, Catherine

    2014-02-05

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

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

    PubMed Central

    2014-01-01

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

  3. Assessment of patient-reported outcome measures in the surgical treatment of patients with gastric cancer.

    PubMed

    Straatman, Jennifer; van der Wielen, Nicole; Joosten, Pieter J; Terwee, Caroline B; Cuesta, Miguel A; Jansma, Elise P; van der Peet, Donald L

    2016-05-01

    Gastric cancer is responsible for 10 % of all cancer-related deaths worldwide. With improved operative techniques and neo-adjuvant therapy, survival rates are increasing. Outcomes of interest are shifting to quality of life (QOL), with many different tools available. The aim of this study was to assess which patient-reported outcome measures (PROMs) are used to measure QOL after a gastrectomy for cancer. A comprehensive search was conducted for original articles investigating QOL after gastrectomy. Two authors independently selected relevant articles, conducted clinical appraisal and extracted data (P.J. and J.S.). Out of 3414 articles, 26 studies were included, including a total of 4690 patients. These studies included ten different PROMs, which could be divided into generic, symptom-specific and disease-specific questionnaires. The EORTC and the FACT questionnaires use an oncological overall QOL module and an organ-specific module. Only one validation study regarding the use of the EORTC after surgery for gastric cancer was available, demonstrating good psychometric properties and clinical validity. A great variety of PROMs are being used in the measurement of QOL after surgery for gastric cancer. A questionnaire with a general module along with a disease-specific module for the assessment of QOL seems most desirable, such as the EORTC and the FACT with their specific modules. Both are developed in different treatment modalities, such as in surgical patients. EORTC is the most widely used questionnaire and therefore allows for comparison of new studies to existing data. Future studies are needed to assess content validity in surgical gastric cancer patients.

  4. Measuring the value of treatment to patients: patient-reported outcomes in drug development.

    PubMed

    Willke, Richard J

    2008-02-01

    Patient-reported outcomes (PROs) can be important measures of the impact and value of new drug treatments to patients. Recently, both multisector stakeholder groups and the U.S. Food and Drug Administration have carefully considered and issued guidance on best practices for the use of PROs in measuring treatment impact. When best practices are followed and PRO data are appropriately included in drug development strategy and clinical trials, these data can be part of the evidence submitted for drug approval and included in drug labeling. One study showed that PRO data were included in 30% of a sample of new drug labels and were more concentrated in certain therapeutic areas, such as anti-inflammatory agents, vaccines, gastrointestinal agents, and respiratory and urologic agents. PRO data included in labeling, or generated in a similar scientific manner, may often then be used in other communication vehicles, such as formulary submission dossiers, journal or direct-to-consumer advertisements, publications, or continuing medical education. Meaningful and reliable PRO results regarding the effects of new treatments on how patients feel and function provide useful information to those who must make decisions about the availability and utilization of such treatments.

  5. Fatigue, patient reported outcomes, and objective measurement of physical activity in systemic lupus erythematosus.

    PubMed

    Mahieu, M A; Ahn, G E; Chmiel, J S; Dunlop, D D; Helenowski, I B; Semanik, P; Song, J; Yount, S; Chang, R W; Ramsey-Goldman, R

    2016-10-01

    Fatigue is a common symptom in systemic lupus erythematosus (SLE), and engaging in physical activity may reduce fatigue. We aimed to characterize relationships between fatigue, other health status measures assessed with the Patient Reported Outcomes Measurement Information System (PROMIS) instruments, and accelerometer-based physical activity measurements in patients with SLE. The internal consistency of each PROMIS measure in our SLE sample was also evaluated. This cross-sectional study analyzed 123 adults with SLE. The primary fatigue outcome was Fatigue Severity Scale score. Secondary outcomes were PROMIS standardized T-scores in seven health status domains. Accelerometers were worn for seven days, and mean daily minutes of light, moderate/vigorous, and bouted (10 minutes) moderate/vigorous physical activity were estimated. Cronbach's alpha was determined for each PROMIS measure to assess internal consistency. Relationships between Fatigue Severity Scale, PROMIS, and physical activity were summarized with Spearman partial correlation coefficients (r), adjusted for average daily accelerometer wear time. Mean Fatigue Severity Scale score (4.3, SD 1.6) was consistent with clinically relevant levels of fatigue. Greater daily and bouted moderate/vigorous physical activity minutes correlated with lower Mean Fatigue Severity Scale score (r = -0.20, p = 0.03 and r = -0.30, p = 0.0007, respectively). For PROMIS, bouted moderate/vigorous physical activity minutes correlated with less fatigue (r = -0.20, p = 0.03). PROMIS internal consistency was excellent, with Cronbach's alpha > 0.90 for each domain. Mean PROMIS T-scores for fatigue, pain interference, anxiety, sleep disturbance, sleep-related impairment, and physical function were worse than reported for the general US population. More moderate/vigorous physical activity minutes were associated with less pain interference (r = -0.22, p = 0.01). Both light physical activity and

  6. Patient-reported outcome measures in psoriasis: the good, the bad and the missing!

    PubMed

    Kitchen, H; Cordingley, L; Young, H; Griffiths, C E M; Bundy, C

    2015-01-01

    As a long-term condition, psoriasis demands significant personal and professional input for optimal self-management. Low levels of well-being and high levels of psychological distress in patients with psoriasis are associated with reduced resources for self-care. Patient-reported outcome (PRO) measures can be used to assess physical, social and psychological functioning in order to guide treatment. In this article, we systematically reviewed the development and validation of existing PRO measures. PubMed (Medline), PsycINFO and CINAHL were searched systematically using predefined search terms. The search was limited to articles in the English language relating to human subjects. Articles were selected for full review through explicit inclusion/exclusion criteria. PRO measures were critically reviewed in accordance with the published guidelines and theory on the development and validation of PROs. The search identified 967 abstracts; 71 of these articles met the criteria for full review. In these 71 articles, 45 PRO measures were found: 16 were specific to psoriasis, 21 assessed other dermatological conditions and eight were developed for generic nondermatological health conditions. The review revealed several limitations of the existing measures, including: (i) a composite structure assessing multiple, poorly-defined concepts; (ii) a lack of evidence for face and content validity; (iii) a failure to include both patient and clinician perspectives and requirements and (iv) a lack of evidence regarding the feasibility and acceptability for patients and physicians. No single PRO measure with adequate evidence of validity, reliability and sensitivity to change captures patient well-being in psoriasis. A valid, sensitive, specific and acceptable PRO that assesses the full impact of psoriasis on well-being is needed for the comprehensive clinical management of psoriasis.

  7. Validation of two generic patient-reported outcome measures in patients with type 2 diabetes

    PubMed Central

    Matza, Louis S; Boye, Kristina S; Yurgin, Nicole

    2007-01-01

    Background Prior to using a generic patient-reported outcome measure (PRO), the measure should be validated within the target population. The purpose of the current study was to validate two generic measures in patients with type 2 diabetes. Methods Patients with type 2 diabetes in Scotland and England completed two generic measures: EQ-5D and Psychological General Well-Being Index (PGWB). Two diabetes-specific measures were administered: ADS and DSC-R. Analyses assessed reliability and validity. Results There were 130 participants (53 Scotland; 77 England; 64% male; mean age = 55.7 years). Responses on the EQ-5D and PGWB reflected moderate impairment consistent with previous diabetes samples: mean EQ-5D Index score, 0.75; EQ-5D VAS, 68.8; PGWB global score, 67.9. All scales of the PGWB demonstrated good internal consistency reliability (Cronbach's alpha = 0.77 to 0.97). The EQ-5D and PGWB demonstrated convergent validity through significant correlations with the ADS (r = 0.48 to 0.61), DSC-R scales (r = 0.33 to 0.81 except ophthalmology subscale), and Body Mass Index (r = 0.15 to 0.38). The EQ-5D and PGWB discriminated between groups of patients known to differ in diabetes-related characteristics (e.g., history of hypoglycemia). Conclusion Results support the use of the EQ-5D and PGWB among patients with type 2 diabetes, possibly in combination with condition-specific measures. PMID:17672906

  8. Current status of worldwide use of patient-reported outcome measures (PROMs) in spine care.

    PubMed

    Falavigna, Asdrubal; Dozza, Diego Cassol; Teles, Alisson R; Wong, Chung Chek; Barbagallo, Giuseppe; Brodke, Darrel; Al-Mutair, Abdulaziz; Ghogawala, Zoher; Riew, K Daniel

    2017-09-08

    Patient-reported outcome measures PROMs are the most widely accepted means of measuring outcomes following spine procedures. We sought to determine the current status of worldwide use of PROMs in Latin America (LA), Europe (EU), Asia Pacific (AP), North America (NA), and Middle East (ME) in order to determine the barrier to its full implementation. A questionnaire survey was sent by e-mail to members of AOSpine to evaluate their familiarity and use of PROMs instruments, and to assess the barriers to their use in spine care practice in LA, EU, AP, NA, and ME. A total of 1,634 AOSpine members from LA, EU, AP, NA, and ME answered the electronic questionnaire. The percentage of spine surgeons familiar with the generic health-related quality of life (HRQoL) questionnaire was 71.7%. in addition, 31.9% of respondents did not routinely use any PROMs. The main barriers to implementing PROMs were lack of time to administer the questionnaires (57%) followed by lack of staff to assist in data collection (55%), and the long time to fill out the questionnaires (46%). The routine use of questionnaires was more frequent in NA and EU and less common in LA and ME (p<0.001). We found that 31.9% of spine surgeons do not routinely use the PROMs questionnaire. This appears to occur because of lack of knowledge regarding their importance, absence of reimbursement for this extra work, minimal financial support for clinical research, the cost of implementation and lack of concern among physicians. Copyright © 2017 Elsevier Inc. All rights reserved.

  9. Use of an electronic patient-reported outcome measurement system to improve distress management in oncology

    PubMed Central

    Smith, Sophia K.; Rowe, Krista; Abernethy, Amy P.

    2014-01-01

    Objective Management of patient distress is a critical task in cancer nursing and cancer practice. Here we describe two examples of how an electronic patient-reported outcome (ePRO) measurement system implemented into routine oncology care can practically aid clinical and research tasks related to distress management. Methods Tablet personal computers were used to routinely complete a standardized ePRO review of systems surveys at point of care during every encounter in the Duke Oncology outpatient clinics. Two cases of use implementation are explored: (1) triaging distressed patients for optimal care, and (2) psychosocial program evaluation research. Results Between 2009 and 2011, the ePRO system was used to collect information during 17,338 Duke Oncology patient encounters. The system was used to monitor patients for psychosocial distress employing an electronic clinical decision support algorithm, with 1,952 (11.3%) referrals generated for supportive services. The system was utilized to examine the efficacy of a psychosocial care intervention documenting statistically significant improvements in distress, despair, fatigue, and quality of life (QOL) in 50 breast cancer patients. Significance of results ePRO solutions can guide best practice management of cancer patient distress. Nurses play a key role in implementation and utilization. PMID:24128592

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

    PubMed

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

    2017-09-01

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

  11. Patient reported outcome measures for visual impairment after stroke: a systematic review.

    PubMed

    Hepworth, Lauren R; Rowe, Fiona J; Harper, Robert; Jarvis, Kathryn; Shipman, Tracey; Rodgers, Helen

    2015-09-15

    The aim of this review was to identify patient reported outcome measures (PROMs) for use in research and clinical practice involving individuals with visual impairment following stroke and to evaluate their content validity against quality assessment criteria. A systematic review of the literature was conducted to identify articles related to the development and/or validation of PROMS. We searched scholarly online resources and hand searched journals. Search terms included MESH terms and alternatives relating to PROMs, visual impairments and quality of life. Data were extracted relating to the development and validation of the included instruments. The quality of the development process was assessed using a modified version of a PROM quality assessment tool. A total of 142 PROMs were identified, 34 vision-specific PROMs were relevant and available to be analysed in this review. Quality appraisal identified four highly rated instruments: the National Eye Institute Visual Functional Questionnaire (NEI-VFQ), Activity Inventory (AI), Daily Living Tasks Dependant on Vision (DLTV) and Veterans Affairs Low Visual Function Questionnaire (VA LV VFQ). The four instruments have only been used with either a limited number of stroke survivors or a sub-population within visual impairment following stroke. No instruments were identified which specifically targeted individuals with visual impairment following stroke. Further research is required to identify the items which a population of stroke survivors with visual impairment consider to be of most importance. The validation of a combination of instruments or a new instrument for use with this population is required.

  12. Joint awareness after ACL reconstruction: patient-reported outcomes measured with the Forgotten Joint Score-12.

    PubMed

    Behrend, Henrik; Zdravkovic, Vilijam; Giesinger, Johannes M; Giesinger, Karlmeinrad

    2017-05-01

    To measure joint awareness in patients who have undergone anterior cruciate ligament (ACL) reconstruction and to investigate medium- and long-term results of the procedure. All patients who had undergone ACL reconstruction with the same arthroscopic surgical technique at our institution between 2011 and 2014 (medium-term follow-up group (Group I)) or between 2000 and 2005 (long-term follow-up group (Group II)) were considered for inclusion in the study. A group of healthy controls were recruited to obtain reference values for the FJS-12 (Forgotten Joint Score-12). Propensity score matching was applied to improve comparability of patients and healthy controls in terms of sex and age. Fifty-eight patients of the Group I (mean follow-up 31.5 (SD13.4) months, range 12-54), 57 patients of the Group II (mean follow-up 139 (SD15.2) months, range 120-179), and the healthy control samples (100 individuals) were analysed. Significantly lower FJS-12 was found in both groups (Group I: 71.6 and Group II: 70.1), compared to the two matched control groups (88.1 and 90.0). The concept of joint awareness was successfully applied to evaluate medium- and long-term results of ACL reconstruction. The clinical relevance of this study is that it extends the construct of joint awareness as a patient-reported outcome parameter to ACL reconstruction surgery. Level III.

  13. Relationship of patient-reported outcomes with MRI measures in rheumatoid arthritis.

    PubMed

    Baker, Joshua F; Conaghan, Philip G; Emery, Paul; Baker, Daniel G; Ostergaard, Mikkel

    2017-03-01

    We assessed whether MRI measures of synovitis, osteitis and bone erosion were associated with patient-reported outcomes (PROs) in a longitudinal clinical trial setting among patients with rheumatoid arthritis (RA). This longitudinal cohort of 291 patients with RA was derived from the MRI substudy of the GO-BEFORE randomised controlled trial of golimumab among methotrexate-naïve patients. Correlations between RAMRIS scores (synovitis, osteitis, bone erosion) and physical function (Health Assessment Questionnaire (HAQ)), pain and global patient scores were determined at 0, 12, 24 and 52 weeks. Correlations between interval changes were also assessed. Multivariable regression models using robust generalised estimating equations evaluated associations over all time-points and their relationship to other clinical disease activity measures. Greater synovitis, osteitis and bone erosion scores were positively associated with HAQ at all time-points (all p<0.05) and with pain and patient global scores at 24 and 52 weeks. Over all visits, synovitis was associated with HAQ, pain and patient global scores (p≤0.03) independent of clinical disease activity measures. Improvements in synovitis and bone erosion were also associated with improvements in PROs. Less improvement in synovitis and progression in MRI erosion at 52 weeks were both independently associated with worsening in all PROs at 52 weeks while progression on X-ray was not associated. Similar associations were observed across treatment groups. MRI measures of inflammation and structural damage correlate independently with physical function, pain and patient global assessments. These observations support the validity of MRI biomarkers. NCT00264537; Post-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  14. Patient reported outcome measures for measuring dignity in palliative and end of life care: a scoping review.

    PubMed

    Johnston, Bridget; Flemming, Kate; Narayanasamy, Melanie Jay; Coole, Carolyn; Hardy, Beth

    2017-08-22

    Patient reported outcome measures are frequently used standard questionnaires or tools designed to collect information from patients regarding their health status and care. Their use enables accurate and relevant insight into changes in health, quality of life, and symptom severity to be acquired. The purpose of this scoping review was to identify PROMs that had been subject to rigorous development and were suitable for use in palliative and end of life care for clinical practice and/or research purposes. The review had a specific focus on measures which could be used to assess perceptions of dignity in these contexts. A scoping review of English-language papers published between 2005 and 2015. Searches were devised in conjunction with an information science specialist and were undertaken in Medline; PsycINFO; EMBASE; CINAHL; Social Science Citation Index; ASSIA; CENTRAL; CDSR; DARE; HTA; Oxford PROM Bibliography; PROQOLID, using dignity related terms such as personhood; dignity or dignified; patient-centred care; which were linked (via the Boolean operator "AND") to care-related terms such as terminal care; hospice care; palliative care; end of life. Papers were assessed against inclusion criteria and appraised for quality. The search strategy produced an initial 7845 articles. After three rounds of eligibility assessment, eight articles discussing eight patients reported outcome measures were found to meet the inclusion criteria and were included in the final review. These underwent a thorough critical appraisal process. All seven studies were empirical research focused on the development and testing of a PROM. The eight patient reported outcome measures had all undergone some psychometric testing, and covered dignity aspects suggesting that they could be considered for use for research purposes to assess dignity. There were also indications that some could be implemented into a clinical setting. However, each measure had limitations and scope for further

  15. The Implementation of Patient-Reported Outcome Measures in Yoga Therapy.

    PubMed

    Ross, Alyson; Birdee, Gurjeet; Touchton-Leonard, Katharine; Bevans, Margaret

    2016-09-01

    Yoga therapists are interested in knowing whether their therapeutic interventions are helpful in improving health and wellbeing in their yoga therapy clients. However, few yoga therapists use standardized, reliable, and valid questionnaires to determine the therapeutic effectiveness of their treatments. Patient-reported outcome (PRO) measures are paper or web-based questionnaires used to assess an individual's perceptions of their symptoms and/or quality of life. In 2004, the National Institutes of Health (NIH) launched the PROMIS(®) initiative to standardize and simplify the collection of PROs in research and in clinical practice. The PROMIS(®) initiative launched a multicenter cooperative group that collected and reviewed thousands of PROs, then extensively tested them in over 20,000 research participants. The result was a web-based collection of item banks of the best questions or "items" within three domains of interest: physical, mental, and social health. These item banks are housed in the Assessment Center, a free online resource for collecting PROs.(1) Incorporating PROMIS(®) outcomes into yoga therapy streamlines and optimizes the collection of PROs by enabling access to reliable and valid questionnaires that are easy to read, simple to complete, and are available in multiple languages as well as in both adult and pediatric versions. The use of standardized PROs may improve yoga therapy implementation in healthcare and accelerate translation of clinical research by allowing yoga therapists to conduct indepth symptom assessments using tools that allow for comparisons to other therapeutic clinical and research interventions. The purpose of this paper is to summarize the development of the NIH PROMIS(®) initiative and to provide suggestions for incorporating PRO collection into yoga therapy. Important considerations to consider when implementing PROs into yoga therapy are discussed, including the choice of questionnaires and method of delivery (paper or

  16. The Implementation of Patient-Reported Outcome Measures in Yoga Therapy.

    PubMed

    Ross, Alyson; Birdee, Gurjeet; Touchton-Leonard, Katharine; Bevans, Margaret

    2016-01-01

    Yoga therapists are interested in knowing whether their therapeutic interventions are helpful in improving health and wellbeing in their yoga therapy clients. However, few yoga therapists use standardized, reliable, and valid questionnaires to determine the therapeutic effectiveness of their treatments. Patient-reported outcome (PRO) measures are paper or web-based questionnaires used to assess an individual's perceptions of their symptoms and/or quality of life. In 2004, the National Institutes of Health (NIH) launched the PROMIS(®) initiative to standardize and simplify the collection of PROs in research and in clinical practice. The PROMIS(®) initiative launched a multicenter cooperative group that collected and reviewed thousands of PROs, then extensively tested them in over 20,000 research participants. The result was a web-based collection of item banks of the best questions or "items" within three domains of interest: physical, mental, and social health. These item banks are housed in the Assessment Center, a free online resource for collecting PROs.(1) Incorporating PROMIS(®) outcomes into yoga therapy streamlines and optimizes the collection of PROs by enabling access to reliable and valid questionnaires that are easy to read, simple to complete, and are available in multiple languages as well as in both adult and pediatric versions. The use of standardized PROs may improve yoga therapy implementation in healthcare and accelerate translation of clinical research by allowing yoga therapists to conduct indepth symptom assessments using tools that allow for comparisons to other therapeutic clinical and research interventions. The purpose of this paper is to summarize the development of the NIH PROMIS(®) initiative and to provide suggestions for incorporating PRO collection into yoga therapy. Important considerations to consider when implementing PROs into yoga therapy are discussed, including the choice of questionnaires and method of delivery (paper or

  17. A Review of HIV-Specific Patient-Reported Outcome Measures.

    PubMed

    Engler, Kim; Lessard, David; Lebouché, Bertrand

    2016-09-16

    The use of patient-reported outcome (PRO) measures to provide added feedback to health providers is receiving interest as a means of improving clinical care and patient outcomes, and contributing to more patient-centered care. In human immunodeficiency virus (HIV), while PROs are used in research, their application in clinical practice has been limited despite their potential utility. PRO selection is an important consideration when contemplating their use. As past reviews of PROs in HIV have focused on particular areas (e.g. disability, satisfaction with care), a more comprehensive review could better inform on the available instruments and their scope. This article reviews HIV-specific PROs to produce an inventory and to identify the central concepts targeted over time. Seven databases were searched (HAPI, MEDLINE, PsychINFO, PubMed, EMBASE, CINAHL, Google Scholar), generating 14,794 records for evaluation. From these records, 117 HIV-specific PROs were identified and categorized based on a content analysis of their targeted concept: Health-Related Quality of Life (23; 20 %), ART and Adherence-Related Views and Experiences (19; 16 %), Healthcare-Related Views and Experiences (15; 13 %), Psychological Challenges (12; 10 %), Symptoms (12; 10 %), Psychological Resources (10; 9 %), HIV Self-Management and Self-Care (8; 7 %), HIV-Related Stigma (8; 7 %), Body and Facial Appearance (4; 3 %), Social Support (3; 3 %), Sexual and Reproductive Health (2; 2 %), and Disability (1; 1 %). This review highlights the variety and evolution of HIV-specific PROs, with the arrival of seven categories of PROs only after the advent of highly-active antiretroviral therapy. Our inventory also offers a useful resource. However, the interest of further HIV-specific PRO development should be explored in sexual health, which received little independent attention.

  18. Minimal important differences for fatigue patient reported outcome measures-a systematic review.

    PubMed

    Nordin, Åsa; Taft, Charles; Lundgren-Nilsson, Åsa; Dencker, Anna

    2016-05-26

    Fatigue is the most frequent symptom reported by patients with chronic illnesses. As a subjective experience, fatigue is commonly assessed with patient-reported outcome measures (PROMs). Currently, there are more than 40 generic and disease-specific PROMs for assessing fatigue in use today. The interpretation of changes in PROM scores may be enhanced by estimates of the so-called minimal important difference (MID). MIDs are not fixed attributes of PROMs but rather vary in relation to estimation method, clinical and demographic characteristics of the study group, etc. The purpose of this paper is to compile published MIDs for fatigue PROMs, spanning diagnostic/patient groups and estimation methods, and to provide information relevant for appraising their appropriateness for use in specific clinical trials and in monitoring fatigue in defined patient groups in routine clinical practice. A systematic search of three databases (Scopus, CINAHL and Cochrane) for studies published between January 2000 to April 2015 using fatigue and variations of the term MID, e.g. MCID, MIC, etc. Two authors screened search hits and extracted data independently. Data regarding MIDs, anchors used and study designs were compiled in tables. Included studies (n = 41) reported 60 studies or substudies estimating MID for 28 fatigue scales, subscales or single item measures in a variety of diagnostic groups and study designs. All studies used anchor-based methods, 21/60 measures also included distribution-based methods and 17/60 used triangulation of methods. Both similarities and dissimilarities were seen within the MIDs. Magnitudes of published MIDs for fatigue PROMs vary considerably. Information about the derivation of fatigue MIDs is needed to evaluate their applicability and suitability for use in clinical practice and research.

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

    PubMed

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

    2017-08-01

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

  20. Equivalence of electronic and paper-based patient-reported outcome measures.

    PubMed

    Campbell, Niloufar; Ali, Faraz; Finlay, Andrew Y; Salek, Sam S

    2015-08-01

    Electronic formats (ePROs) of paper-based patient-reported outcomes (PROs) should be validated before they can be reliably used. This review aimed to examine studies investigating measurement equivalence between ePROs and their paper originals to identify methodologies used and to determine the extent of such validation. Three databases (OvidSP, Web of Science and PubMed) were searched using a set of keywords. Results were examined for compliance with inclusion criteria. Articles or abstracts that directly compared screen-based electronic versions of PROs with their validated paper-based originals, with regard to their measurement equivalence, were included. Publications were excluded if the only instruments reported were stand-alone visual analogue scales or interactive voice response formats. Papers published before 2007 were excluded, as a previous meta-analysis examined papers published before this time. Fifty-five studies investigating 79 instruments met the inclusion criteria. 53 % of the 79 instruments studied were condition specific. Several instruments, such as the SF-36, were reported in more than one publication. The most frequently reported formats for ePROs were Web-based versions. In 78 % of the publications, there was evidence of equivalence or comparability between the two formats as judged by study authors. Of the 30 publications that provided preference data, 87 % found that overall participants preferred the electronic format. When examining equivalence between paper and electronic versions of PROs, formats are usually judged by authors to be equivalent. Participants prefer electronic formats. This literature review gives encouragement to the further widespread development and use of ePROs.

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

    PubMed Central

    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

  2. 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

    2013-12-20

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

  3. What is sufficient evidence for the reliability and validity of patient-reported outcome measures?

    PubMed

    Frost, Marlene H; Reeve, Bryce B; Liepa, Astra M; Stauffer, Joseph W; Hays, Ron D

    2007-01-01

    This article focuses on the necessary psychometric properties of a patient-reported outcomes (PROs) measure. Topics include the importance of reliability and validity, psychometric approaches used to provide reliability and validity estimates, the kinds of evidence needed to indicate that a PRO has a sufficient level of reliability and validity, contexts that may affect psychometric properties, methods available to evaluate PRO instruments when the context varies, and types of reliability and validity testing that are appropriate during different phases of clinical trials. Points discussed include the perspective that the psychometric properties of reliability and validity are on a continuum in which the more evidence one has, the greater confidence there is in the value of the PRO data. Construct validity is the type of validity most frequently used with PRO instruments as few "gold standards" exist to allow the use of criterion validity and content validity by itself only provides beginning evidence of validity. Several guidelines are recommended for establishing sufficient evidence of reliability and validity. For clinical trials, a minimum reliability threshold of 0.70 is recommended. Sample sizes for testing should include at least 200 cases and results should be replicated in at least one additional sample. At least one full report on the development of the instrument and one on the use of the instrument are deemed necessary to evaluate the PRO psychometric properties. Psychometric testing ideally occurs before the initiation of Phase III trials. When testing does not occur prior to a Phase III trial, considerable risk is posed in relation to the ability to substantiate the use of the PRO data. Various qualitative (e.g., focus groups, behavioral coding, cognitive interviews) and quantitative approaches (e.g., differential item functioning testing) are useful in evaluating the reliability and validity of PRO instruments.

  4. Patient-Reported Outcomes Measurement Information System in Children with Crohn's Disease.

    PubMed

    Arvanitis, Marina; DeWalt, Darren A; Martin, Christopher F; Long, Millie D; Chen, Wenli; Jaeger, Beth; Sandler, Robert S; Kappelman, Michael D

    2016-07-01

    To assess the criterion validity and responsiveness of Patient-Reported Outcomes Measurement Information System (PROMIS) in a web-based cohort of children with Crohn's disease. We recruited children with Crohn's disease (ages 9-17 years) and their parents from the web-based Crohn's and Colitis Foundation of America Kids and Teens Study cohort. Upon entry into the cohort and 6 months later, children self-reported Crohn's disease activity, health-related quality of life, and PROMIS domains of pain interference, anxiety, depression, fatigue, and peer relationships. Mean PROMIS scores for the 276 participating patients were worse among those with worse self-reported Crohn's disease activity (per Short Crohn's Disease Activity Index, P < .005 for all), Crohn's disease activity in the prior 6 months (per Manitoba Index, P < .01 for all), and health-related quality of life (per IMPACT-35, P < .001 for all). One hundred forty-three patients and their parents completed follow-up questionnaires, 75% of whom reported stable disease activity. Those with improved Crohn's disease activity reported improved PROMIS scores, and those with worsened Crohn's disease activity reported worse PROMIS scores for all domains except anxiety. All participants reported improved anxiety from baseline, but those with stable or worsened Crohn's disease activity reported less improvement (P = .07). PROMIS scores were significantly associated with Crohn's disease activity in a linear and clinically meaningful manner, and responded to change in Crohn's disease activity over a 6-month period. This supports the criterion validity and responsiveness of pediatric PROMIS. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. Patient-reported outcome measures after routine periodontal and implant surgical procedures.

    PubMed

    Tan, Wah Ching; Krishnaswamy, Gita; Ong, Marianne M A; Lang, Niklaus P

    2014-06-01

    To compare patient-reported outcome measures (PROMs) after different dental surgical procedures over a 1-week post-surgical period and in relation to duration of the surgery, and periosteal releasing incisions. To evaluate the prevalence of post-surgical complications. Four hundred and sixty-eight healthy dental patients requiring surgeries, such as crown lengthening (CL), open flap debridement (OFD) and implant installation (IMP) in the National Dental Centre, Singapore (2009-2011), were consecutively recruited. PROMs on bleeding, swelling, pain and bruising were obtained using Visual Analogue Scales (VAS) on days 0, 3, 5 and 7 post-operatively. On the day of surgery, the IMP procedure gave the lowest median VAS for all four PROM parameters. After a week, OFD still had a significantly higher VAS for swelling, pain and bruising. Patients who underwent procedures lasting more than 60 min. had higher VAS for all parameters except bleeding. After considering other important confounders, type of surgery procedure was no longer associated with the VAS score for any of the parameters. Time after surgery, male gender and shorter surgery duration reduced post-operative VAS for one or more of the parameters. Longer surgeon experience helps reduce VAS scores only for bleeding. Prevalence for tenderness to palpation was 11.6%, 8.9% and 12.2% for IMP, CL and OFD, respectively, 1-week post-operatively. Swelling and suppuration occurred rarely. The median VAS scores for all PROM parameters were generally low and reduced to near zero over a week following all three surgical procedures tested. Time after surgery and shorter surgery duration were associated with lower VAS scores in all the PROM parameters in this cohort of patients. Surgery type was not associated significantly with VAS after adjustment with other important confounders. Low prevalences of post-surgical complications were reported. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  6. Whose quality of life? Ethical implications in patient-reported health outcome measurement.

    PubMed

    Hagell, Peter; Reimer, Jan; Nyberg, Per

    2009-06-01

    Patient-reported health status questionnaires intend to assess illness and therapy from the patients' perspective. To provide fair and valid assessments, they should be equally relevant to major subsets of respondents. Furthermore, disease-specific measures are assumed to be perceived as more relevant than generic ones. This study assessed these assumptions among people with Parkinson's disease. Cross-sectional data from 202 people with Parkinson's disease (54% men; mean age, 70) were analyzed regarding patient-rated relevance and predictors of patient-rated poor relevance of two generic [the 36-item Short Form Health Survey (SF-36) and Nottingham Health Profile (NHP)] and one disease-specific [Parkinson's Disease Questionnaire (PDQ-39)] health status questionnaire. There were no differences in relevance ratings across the questionnaires. Poorer overall quality of life [odds ratio (OR), 2.459] and mental health (OR, 1.023) were associated with poorer patient-rated relevance of the SF-36, and higher age was associated with poorer patient-rated relevance of the PDQ-39 (OR, 1.040). No significant predictors were found for the NHP. The PDQ-39 failed to meet the assumption that disease-specific scales are more relevant than generic ones. Nevertheless, the most important implication of this study is an ethical one. Because the relevance of the SF-36 and PDQ-39 is perceived as poorer by those who fare least well and by older people, these scales may not reflect the perspectives of these groups. This challenges bioethical principles and threatens scientific validity. Perceived relevance of patient-centered outcomes needs to be considered, or the voice of vulnerable groups may be silenced, fair inferences prohibited, and opportunities for improved care lost.

  7. 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

  8. A systematic review of patient-reported outcome measures of neuropathy in children, adolescents and young adults

    PubMed Central

    Sung, Lillian; Stark, Daniel; Frazier, A. Lindsay; Rosenberg, Abby R.

    2017-01-01

    Purpose Peripheral neuropathy is an important, yet poorly studied, side effect of pediatric cancer treatment. There are many measures of patient-reported peripheral neuropathy in adults but very few in children. We aimed to systematically review and summarize reliable and valid patient-reported peripheral neuropathy scales used in pediatrics. Methods Four major electronic databases (Medline, Embase, EBSCO Host in Cumulative Index to Nursing and Allied Health Literature, and PsycINFO) were reviewed for studies that measured peripheral neuropathy in pediatric patients. Studies eligible for inclusion were those that described use of any patient-reported scale of peripheral neuropathy among children, adolescents, and young adults with any underlying diagnosis (not limited to cancer). Results From a total of 765 articles retrieved, 5 met eligibility criteria and were included. One was a neuropathy symptom score used in patients with diabetes, and the remaining four were in oncology patients and all were based on the total neuropathy score. All involved objective assessments conducted by trained professionals; none relied purely on patient report. Conclusions There are no validated instruments that consist solely of a patient-reported outcome measure of neuropathy in pediatrics and adolescents. Because the clinical evaluation of neuropathy requires specialized training, it is not generalizable in large studies conducted in many diverse institutions. Future studies should validate adult patient-reported neuropathy scales in pediatric and adolescent populations, or develop novel instruments designed for this population. PMID:27037813

  9. A systematic review of patient-reported outcome measures of neuropathy in children, adolescents and young adults.

    PubMed

    Johnston, Donna L; Sung, Lillian; Stark, Daniel; Frazier, A Lindsay; Rosenberg, Abby R

    2016-09-01

    Peripheral neuropathy is an important, yet poorly studied, side effect of pediatric cancer treatment. There are many measures of patient-reported peripheral neuropathy in adults but very few in children. We aimed to systematically review and summarize reliable and valid patient-reported peripheral neuropathy scales used in pediatrics. Four major electronic databases (Medline, Embase, EBSCO Host in Cumulative Index to Nursing and Allied Health Literature, and PsycINFO) were reviewed for studies that measured peripheral neuropathy in pediatric patients. Studies eligible for inclusion were those that described use of any patient-reported scale of peripheral neuropathy among children, adolescents, and young adults with any underlying diagnosis (not limited to cancer). From a total of 765 articles retrieved, 5 met eligibility criteria and were included. One was a neuropathy symptom score used in patients with diabetes, and the remaining four were in oncology patients and all were based on the total neuropathy score. All involved objective assessments conducted by trained professionals; none relied purely on patient report. There are no validated instruments that consist solely of a patient-reported outcome measure of neuropathy in pediatrics and adolescents. Because the clinical evaluation of neuropathy requires specialized training, it is not generalizable in large studies conducted in many diverse institutions. Future studies should validate adult patient-reported neuropathy scales in pediatric and adolescent populations, or develop novel instruments designed for this population.

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

    PubMed

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

    2017-03-01

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

  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. Correlation of the Patient Reported Outcomes Measurement Information System with legacy outcomes measures in assessment of response to lumbar transforaminal epidural steroid injections.

    PubMed

    Shahgholi, L; Yost, K J; Carter, R E; Geske, J R; Hagen, C E; Amrami, K K; Diehn, F E; Kaufmann, T J; Morris, J M; Murthy, N S; Wald, J T; Thielen, K R; Kallmes, D F; Maus, T P

    2015-03-01

    The Patient Reported Outcomes Measurement Information System is a newly developed outcomes measure promulgated by the National Institutes of Health. This study compares changes in pain and physical function-related measures of this system with changes on the Numeric Rating Pain Scale, Roland Morris Disability Index, and the European Quality of Life scale 5D questionnaire in patients undergoing transformational epidural steroid injections for radicular pain. One hundred ninety-nine patients undergoing transforaminal epidural steroid injections for radicular pain were enrolled in the study. Before the procedure, they rated the intensity of their pain by using the 0-10 Numeric Rating Pain Scale, Roland Morris Disability Index, and European Quality of Life scale 5D questionnaire. Patients completed the Patient Reported Outcomes Measurement Information System Physical Function, Pain Behavior, and Pain Interference short forms before transforaminal epidural steroid injections and at 3 and 6 months. Seventy and 43 subjects replied at 3- and 6-month follow-up. Spearman rank correlations were used to assess the correlation between the instruments. The minimally important differences were calculated for each measurement tool as an indicator of meaningful change. All instruments were responsive in detecting changes at 3- and 6-month follow-up (P < .0001). There was significant correlation between changes in Patient Reported Outcomes Measurement Information System scores and legacy questionnaires from baseline to 3 months (P < .05). There were, however, no significant correlations in changes from 3 to 6 months with any of the instruments. The studied Patient Reported Outcomes Measurement Information System domains offered responsive and correlative psychometric properties compared with legacy instruments in a population of patients undergoing transforaminal epidural steroid injections for radicular pain. © 2015 by American Journal of Neuroradiology.

  13. Application of the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS®) to Mental Health Research

    PubMed Central

    Riley, William T.; Pilkonis, Paul; Cella, David

    2013-01-01

    Background The Patient-Reported Outcomes Measurement Information System (PROMIS) is a National Institutes of Health initiative to develop item banks measuring patient-reported outcomes (PROs) and to create and make available a computerized adaptive testing system (CAT) that allows for efficient and precise assessment of PROs in clinical research and practice. Aims of the Study Based on the presentation from a symposium on “Evidence-based Outcomes in Psychiatry: Updates on Measurement Using Patient-Reported Outcomes (PRO)” at the 2011 American Psychiatry Association Convention, this paper provides an overview of PROMIS and its application to mental health research. Methods The PROMIS methodology for item bank development and testing is described, with a focus on the implications of this work for mental health research. Results Utilizing qualitative item review and state-of-the-art applications of item response theory (IRT), PROMIS investigators have developed, tested, and released item banks measuring physical, mental, and social health components. Ongoing efforts continue to add new item banks and further validate existing banks. Discussion PROMIS provides item banks measuring several domains of interest to mental health researchers including emotional distress, social function, and sleep. PROMIS methodology also provides a rigorous standard for the development of new mental health measures. Implications for Health Care Provision Web-based CAT or administration of short forms derived from PROMIS item banks provide efficient and precise dimensional estimates of clinical outcomes that can be utilized to monitor patient progress and assess quality improvement. Implications for Future Research Use of the dimensional PROMIS metrics (and co-calibration of the PROMIS item banks with existing PROs) will allow comparisons of mental health and related health outcomes across disorders and studies. PMID:22345362

  14. PRECiS (Patient Reported Evaluation of Cognitive State): psychometric evaluation of a new patient reported outcome measure of the impact of stroke.

    PubMed

    Patchick, Emma; Vail, Andy; Wood, Alison; Bowen, Audrey

    2016-12-01

    Determine the psychometric properties of PRECiS (Patient Reported Evaluation of Cognitive State): A new patient-centred, patient reported outcome measure for perceived impact of cognitive problems, developed through qualitative work, systematic review and service user consultation. An observational study exploring acceptability, internal consistency, construct validity, inter-rater reliability and test-retest reliability, with opportunistic qualitative data on sensitivity to change. Home visits in the community. Stroke survivors with self-reported cognitive difficulties and informal carers. The 27 item PRECiS was self-completed with support, and proxy completed by informal carers. We collected descriptive cognitive screening test data, and measures of overall stroke impact, mood and activities of daily living to explore construct validity. Data were collected from 159 (visit 1) and 66 (visit 2) stroke survivors and 86 informal carers. PRECiS showed good acceptability (no missing values or floor/ceiling effects, minimal skewness); high internal consistency (α = 0.94, indicative of potential redundancy); with moderate to strong construct correlations in the directions hypothesised (0.40 to 0.74). An intraclass correlation coefficient of 0.85 indicated good test-retest reliability. Where self-reported change had occurred from visit 1 to 2, PRECiS appeared sensitive. Using carers as proxy respondents is not supported by this analysis (inter-rater ICC = 0.43). PRECiS is a patient-centred, practical and reliable measure assessing perceived impact of cognitive problems from the unique perspective of stroke survivors. © The Author(s) 2015.

  15. 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

  16. Patient-Reported Outcome Measures in Individuals With Chronic Ankle Instability: A Systematic Review

    PubMed Central

    Houston, Megan N.; Hoch, Johanna M.; Hoch, Matthew C.

    2015-01-01

    Context  A comprehensive systematic literature review of the health-related quality-of-life (HRQOL) differences among individuals with chronic ankle instability (CAI), ankle-sprain copers, and healthy control participants has not been conducted. It could provide a better indication of the self-reported deficits that may be present in individuals with CAI. Objective  To systematically summarize the extent to which HRQOL deficits are present in individuals with CAI. Data Sources  We searched for articles in the electronic databases of EBSCO Host and PubMed Central using key words chronic, functional, mechanical, coper, instability, sprains, and patient-assessed. We also performed a hand search of reference lists, authors, and patient-reported outcomes (PROs) of the articles screened for inclusion. Study Selection  Studies were included if they (1) incorporated a PRO as a participant descriptor or as a study outcome to compare adults with CAI to ankle-sprain copers or healthy controls, (2) were written in English, and (3) were published in peer-reviewed journals. Data Extraction  Two authors independently assessed methodologic quality using the modified Downs and Black Index. Articles were filtered into 3 categories based on between-groups comparisons: CAI and copers, CAI and healthy control participants, copers and healthy participants. We calculated Hedges g effect sizes and 95% confidence intervals to examine PRO group differences. Data Synthesis  Of the 124 studies assessed for eligibility, 27 were included. A total of 24 articles compared PROs in individuals with CAI and healthy controls, 7 compared individuals with CAI and copers, and 4 compared copers and healthy controls. Quality scores on the modified Downs and Black Index ranged from 52.9% to 88.2%, with 8 high-, 16 moderate-, and 3 low-quality studies. Overall, we observed moderate to strong evidence that individuals with CAI displayed deficits on generic and region-specific PROs compared with

  17. Patient-Reported Outcome Measures in Individuals With Chronic Ankle Instability: A Systematic Review.

    PubMed

    Houston, Megan N; Hoch, Johanna M; Hoch, Matthew C

    2015-10-01

    A comprehensive systematic literature review of the health-related quality-of-life (HRQOL) differences among individuals with chronic ankle instability (CAI), ankle-sprain copers, and healthy control participants has not been conducted. It could provide a better indication of the self-reported deficits that may be present in individuals with CAI. To systematically summarize the extent to which HRQOL deficits are present in individuals with CAI. We searched for articles in the electronic databases of EBSCO Host and PubMed Central using key words chronic, functional, mechanical, coper, instability, sprains, and patient-assessed. We also performed a hand search of reference lists, authors, and patient-reported outcomes (PROs) of the articles screened for inclusion. Studies were included if they (1) incorporated a PRO as a participant descriptor or as a study outcome to compare adults with CAI to ankle-sprain copers or healthy controls, (2) were written in English, and (3) were published in peer-reviewed journals. Two authors independently assessed methodologic quality using the modified Downs and Black Index. Articles were filtered into 3 categories based on between-groups comparisons: CAI and copers, CAI and healthy control participants, copers and healthy participants. We calculated Hedges g effect sizes and 95% confidence intervals to examine PRO group differences. Of the 124 studies assessed for eligibility, 27 were included. A total of 24 articles compared PROs in individuals with CAI and healthy controls, 7 compared individuals with CAI and copers, and 4 compared copers and healthy controls. Quality scores on the modified Downs and Black Index ranged from 52.9% to 88.2%, with 8 high-, 16 moderate-, and 3 low-quality studies. Overall, we observed moderate to strong evidence that individuals with CAI displayed deficits on generic and region-specific PROs compared with copers and healthy controls. However, evidence that differences exist between copers and healthy

  18. 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

  19. Patient-reported outcome measures for chronic wounds with particular reference to pressure ulcer research: a systematic review.

    PubMed

    Gorecki, Claudia; Nixon, Jane; Lamping, Donna L; Alavi, Yasmene; Brown, Julia M

    2014-01-01

    Pressure ulcers are a major health problem, affect patient psychological, physical and social functioning, and cause significant treatment burden. For comprehensive assessment of the benefits of an intervention, patient-reported evidence of the impact of an intervention on important patient outcomes should be made. We systematically reviewed the quality of life literature on chronic wounds to determine the suitability of generic and chronic wound-specific outcome measures for use in evaluating patient outcomes in pressure ulcer research. A systematic review of the literature. Searches of eight electronic databases from inception until May 2012 were undertaken. Quality of life domains, item content and content relevance were determined for identified outcome measures. The content validity of identified measures was assessed against an empirically derived pressure ulcer-specific conceptual framework. Three generic and 14 chronic wound measures were identified but no pressure ulcer-specific measures. None of the existing measures cover all quality of life domains important in pressure ulcers. One condition-specific measure, the Venous Leg Ulcer Measure, matched most closely conceptually, but failed to represent three important domains and contained items not specific to pressure ulcers. Currently, outcomes important in pressure ulcers are inadequately covered by generic and chronic wound-specific instruments despite similar conceptual models. Highlighted is the need for clear conceptualisation of content as well as determining appropriateness when selecting outcome measures in the future. Copyright © 2013 Elsevier Ltd. All rights reserved.

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

    PubMed

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

    2015-10-01

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

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

    PubMed

    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

    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. Five TBI Model Systems centers across the United States. Adults with TBI. 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. Twenty-two TBI-QOL item banks/scales. 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. 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.

  2. Validation of Patient-Reported Outcomes Measurement Information System Computerized Adaptive Tests Against the Foot and Ankle Outcome Score for 6 Common Foot and Ankle Pathologies.

    PubMed

    Koltsov, Jayme C B; Greenfield, Stephen T; Soukup, Dylan; Do, Huong T; Ellis, Scott J

    2017-08-01

    The field of foot and ankle surgery lacks a widely accepted gold-standard patient-reported outcome instrument. With the changing infrastructure of the medical profession, more efficient patient-reported outcome tools are needed to reduce respondent burden and increase participation while providing consistent and reliable measurement across multiple pathologies and disciplines. The primary purpose of the present study was to validate 3 Patient-Reported Outcomes Measurement Information System computer adaptive tests (CATs) most relevant to the foot and ankle discipline against the Foot and Ankle Outcome Score (FAOS) and the Short Form 12 general health status survey in patients with 6 common foot and ankle pathologies. Patients (n = 240) indicated for operative treatment for 1 of 6 common foot and ankle pathologies completed the CATs, FAOS, and Short Form 12 at their preoperative surgical visits, 1 week subsequently (before surgery), and at 6 months postoperatively. The psychometric properties of the instruments were assessed and compared. The Patient-Reported Outcomes Measurement Information System CATs each took less than 1 minute to complete, whereas the FAOS took 6.5 minutes, and the Short Form 12 took 3 minutes. CAT scores were more normally distributed and had fewer floor and ceiling effects than those on the FAOS, which reached as high as 24%. The CATs were more precise than the FAOS and had similar responsiveness and test-retest reliability. The physical function and mobility CATs correlated strongly with the activities subscale of the FAOS, and the pain interference CAT correlated strongly with the pain subscale of the FAOS. The CATs and FAOS were responsive to changes with operative treatment for 6 common foot and ankle pathologies. The CATs performed as well as or better than the FAOS in all aspects of psychometric validity. The Patient-Reported Outcomes Measurement Information System CATs show tremendous potential for improving the study of patient

  3. Ensuring content validity of patient-reported outcomes: a shadow-test approach to their adaptive measurement.

    PubMed

    Choi, Seung W; van der Linden, Wim J

    2017-07-14

    Most computerized adaptive testing (CAT) applications in patient-reported outcomes (PRO) measurement to date are reliability-centric, with a primary objective of maximizing measurement efficiency. A key concern and a potential threat to validity is that, when left unconstrained, individual CAT administrations could have items with systematically different attributes, e.g., sub-domain coverage. This paper aims to provide a solution to the problem from an optimal test design framework using the shadow-test approach to CAT. Following the approach, a case study was conducted using the PROMIS(®) (Patient-Reported Outcomes Measurement Information System) fatigue item bank both with empirical and simulated response data. Comparisons between CAT administrations without and with the enforcement of content and item pool usage constraints were examined. The unconstrained CAT exhibited a high degree of variation in items selected from different substrata of the item bank. Contrastingly, the shadow-test approach delivered CAT administrations conforming to all specifications with a minimal loss in measurement efficiency. The optimal test design and shadow-test approach to CAT provide a flexible framework for solving complex test-assembly problems with better control of their domain coverage than for the conventional use of CAT in PRO measurement. Applications in a wide array of PRO domains are expected to lead to more controlled and balanced use of CAT in the field.

  4. Measuring cough severity: development and pilot testing of a new seven-item cough severity patient-reported outcome measure.

    PubMed

    Vernon, Margaret; Kline Leidy, Nancy; Nacson, Alise; Nelsen, Linda

    2010-08-01

    Although chronic and subacute cough are clinically problematic and a target of therapeutic interventions, there are no validated cough severity patient-reported outcome (PRO) instruments for comprehensively evaluating cough severity in clinical trials. The Cough Severity Diary (CSD) is a simple, seven-item daily diary developed to meet this need. The objective of this study was to assess preliminary measurement characteristics in a small sample of patients with chronic or subacute cough. Thirty-nine patients (24 chronic; 15 subacute) participated in a two-week prospective pilot study. Patients completed the CSD each evening and validation instruments (cough severity visual analog scale [VAS], Leicester Cough Questionnaire [LCQ], Medical Outcomes Study 36-Item Short Form [SF-36], Work Productivity Index [WPAI], MOS Sleep Scale [MOS-SS]) at baseline, days 8 and 15, and a global rating of change at days 8 and 15. Confirmatory factor analyses supported three severity subscales: frequency (three items), intensity (two items), and disruption (two items) (chi(2) = 10.57 (11)). For the CSD total score, internal consistency (alpha) on day 1 was 0.89, and on day 8 was 0.96; reproducibility (intraclass correlation coefficients [ICC]) was 0.68 on day 1 to day 8 and 0.94 on day 8 to day 15. CSD total scores correlated with the VAS (r = 0.84, p < 0.0001), LCQ total (r =-0.62, p < 0.0001) and subscale scores (r =-0.43, p < 0.01 to -0.60, p < 0.0001), and WPAI subscale scores (r = 0.27 (ns) to 0.51, p < 0.01). No significant relationships with SF-36 or MOS-SS were found. Subacute patients showed significant improvement over time (F = 3.20, p < 0.05). Results suggest that the CSD is ready for further testing in larger naturalistic studies or as an exploratory endpoint in clinical trials of patients with subacute or chronic cough.

  5. Patient empowerment: The need to consider it as a measurable patient-reported outcome for chronic conditions

    PubMed Central

    2012-01-01

    Background Health policy in the UK and elsewhere is prioritising patient empowerment and patient evaluations of healthcare. Patient reported outcome measures now take centre-stage in implementing strategies to increase patient empowerment. This article argues for consideration of patient empowerment itself as a directly measurable patient reported outcome for chronic conditions, highlights some issues in adopting this approach, and outlines a research agenda to enable healthcare evaluation on the basis of patient empowerment. Discussion Patient empowerment is not a well-defined construct. A range of condition-specific and generic patient empowerment questionnaires have been developed; each captures a different construct e.g. personal control, self-efficacy/self-mastery, and each is informed by a different implicit or explicit theoretical framework. This makes it currently problematic to conduct comparative evaluations of healthcare services on the basis of patient empowerment. A case study (clinical genetics) is used to (1) illustrate that patient empowerment can be a valued healthcare outcome, even if patients do not obtain health status benefits, (2) provide a rationale for conducting work necessary to tighten up the patient empowerment construct (3) provide an exemplar to inform design of interventions to increase patient empowerment in chronic disease. Such initiatives could be evaluated on the basis of measurable changes in patient empowerment, if the construct were properly operationalised as a patient reported outcome measure. To facilitate this, research is needed to develop an appropriate and widely applicable generic theoretical framework of patient empowerment to inform (re)development of a generic measure. This research should include developing consensus between patients, clinicians and policymakers about the content and boundaries of the construct before operationalisation. This article also considers a number of issues for society and for healthcare

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

    PubMed Central

    Irwin, Debra E; Varni, James W; Yeatts, Karin; DeWalt, Darren A

    2009-01-01

    Background The evaluation of patient-reported outcomes (PROs) in health care has seen greater use in recent years, and methods to improve the reliability and validity of PRO instruments are advancing. This paper discusses the cognitive interviewing procedures employed by the Patient Reported Outcomes Measurement Information System (PROMIS) pediatrics group for the purpose of developing a dynamic, electronic item bank for field testing with children and adolescents using novel computer technology. The primary objective of this study was to conduct cognitive interviews with children and adolescents to gain feedback on items measuring physical functioning, emotional health, social health, fatigue, pain, and asthma-specific symptoms. Methods A total of 88 cognitive interviews were conducted with 77 children and adolescents across two sites on 318 items. From this initial item bank, 25 items were deleted and 35 were revised and underwent a second round of cognitive interviews. A total of 293 items were retained for field testing. Results Children as young as 8 years of age were able to comprehend the majority of items, response options, directions, recall period, and identify problems with language that was difficult for them to understand. Cognitive interviews indicated issues with item comprehension on several items which led to alternative wording for these items. Conclusion Children ages 8–17 years were able to comprehend most item stems and response options in the present study. Field testing with the resulting items and response options is presently being conducted as part of the PROMIS Pediatric Item Bank development process. PMID:19166601

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

    PubMed

    Irwin, Debra E; Varni, James W; Yeatts, Karin; DeWalt, Darren A

    2009-01-23

    The evaluation of patient-reported outcomes (PROs) in health care has seen greater use in recent years, and methods to improve the reliability and validity of PRO instruments are advancing. This paper discusses the cognitive interviewing procedures employed by the Patient Reported Outcomes Measurement Information System (PROMIS) pediatrics group for the purpose of developing a dynamic, electronic item bank for field testing with children and adolescents using novel computer technology. The primary objective of this study was to conduct cognitive interviews with children and adolescents to gain feedback on items measuring physical functioning, emotional health, social health, fatigue, pain, and asthma-specific symptoms. A total of 88 cognitive interviews were conducted with 77 children and adolescents across two sites on 318 items. From this initial item bank, 25 items were deleted and 35 were revised and underwent a second round of cognitive interviews. A total of 293 items were retained for field testing. Children as young as 8 years of age were able to comprehend the majority of items, response options, directions, recall period, and identify problems with language that was difficult for them to understand. Cognitive interviews indicated issues with item comprehension on several items which led to alternative wording for these items. Children ages 8-17 years were able to comprehend most item stems and response options in the present study. Field testing with the resulting items and response options is presently being conducted as part of the PROMIS Pediatric Item Bank development process.

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

    PubMed Central

    Kyte, Derek; Cockwell, Paul; Marshall, Tom; Gheorghe, Adrian; Keeley, Thomas; Slade, Anita; Calvert, Melanie

    2017-01-01

    Background Patient-reported outcome measures (PROMs) can provide valuable information which may assist with the care of patients with chronic kidney disease (CKD). However, given the large number of measures available, it is unclear which PROMs are suitable for use in research or clinical practice. To address this we comprehensively evaluated studies that assessed the measurement properties of PROMs in adults with CKD. Methods Four databases were searched; reference list and citation searching of included studies was also conducted. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist was used to appraise the methodological quality of the included studies and to inform a best evidence synthesis for each PROM. Results The search strategy retrieved 3,702 titles/abstracts. After 288 duplicates were removed, 3,414 abstracts were screened and 71 full-text articles were retrieved for further review. Of these, 24 full-text articles were excluded as they did not meet the eligibility criteria. Following reference list and citation searching, 19 articles were retrieved bringing the total number of papers included in the final analysis to 66. There was strong evidence supporting internal consistency and moderate evidence supporting construct validity for the Kidney Disease Quality of Life-36 (KDQOL-36) in pre-dialysis patients. In the dialysis population, the KDQOL-Short Form (KDQOL-SF) had strong evidence for internal consistency and structural validity and moderate evidence for test-retest reliability and construct validity while the KDQOL-36 had moderate evidence of internal consistency, test-retest reliability and construct validity. The End Stage Renal Disease-Symptom Checklist Transplantation Module (ESRD-SCLTM) demonstrated strong evidence for internal consistency and moderate evidence for test-retest reliability, structural and construct validity in renal transplant recipients. Conclusions We suggest considering the

  9. Outcomes, health policy, and managed care: relationships between patient-reported outcome measures and clinical measures in outpatients with heart failure.

    PubMed

    Flynn, Kathryn E; Lin, Li; Ellis, Stephen J; Russell, Stuart D; Spertus, John A; Whellan, David J; Piña, Ileana L; Fine, Lawrence J; Schulman, Kevin A; Weinfurt, Kevin P

    2009-10-01

    Patient-reported outcomes are increasingly used to assess the efficacy of new treatments. Understanding relationships between these and clinical measures can facilitate their interpretation. We examined associations between patient-reported measures of health-related quality of life and clinical indicators of disease severity in a large, heterogeneous sample of patients with heart failure. Patient-reported measures, including the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the EuroQol Visual Analog Scale (VAS), and clinical measures, including peak VO(2), 6-minute walk distance, and New York Heart Association (NYHA) class, were assessed at baseline in 2331 patients with heart failure. We used general linear models to regress patient-reported measures on each clinical measure. Final models included for significant sociodemographic variables and 2-way interactions. The KCCQ was correlated with peak VO(2) (r = .21) and 6-minute walk distance (r = .27). The VAS was correlated with peak VO(2) (r = .09) and 6-minute walk distance (r = .11). Using the KCCQ as the response variable, a 1-SD difference in peak Vo(2) (4.7 mL/kg/min) was associated with a 2.86-point difference in the VAS (95% CI, 1.98-3.74) and a 4.75-point difference in the KCCQ (95% CI, 3.78-5.72). A 1-SD difference in 6-minute walk distance (105 m) was associated with a 2.78-point difference in the VAS (95% CI, 1.92-3.64) and a 5.92-point difference in the KCCQ (95% CI, 4.98-6.87); NYHA class III was associated with an 8.26-point lower VAS (95% CI, 6.59-9.93) and a 12.73-point lower KCCQ (95% CI, 10.92-14.53) than NYHA class II. These data may inform deliberations about how to best measure benefits of heart failure interventions, and they generally support the practice of considering a 5-point difference on the KCCQ and a 3-point difference on the VAS to be clinically meaningful.

  10. Outcomes of ptosis surgery assessed using a patient-reported outcome measure: an exploration of time effects.

    PubMed

    Mahroo, Omar A; Hysi, Pirro G; Dey, Sarju; Gavin, Elizabeth A; Hammond, Christopher J; Jones, Carole A

    2014-03-01

    To explore effects of time following ptosis surgery on patient-reported quality-of-life outcomes. The Glasgow Benefit Inventory (GBI), a validated, postinterventional questionnaire was administered to consecutive adults undergoing ptosis surgery on the operating list of one surgeon over a 30-month period. Patients who were not contactable or unable to provide answers were excluded. Mean scores of patients grouped by time since surgery were compared (unpaired t test and Westlake intervals to test equivalence). Of 63 consecutive patients, 50 (79%) were included. Mean age was 63 years. Mean time since surgery was 561 days (range 21-973). There was no significant difference in mean total scores of patients assessed less than 18 months since surgery compared with those assessed later (p=0.544). Distributions of total scores were similar. No significant differences were found for subscores or when patients were divided into three groups according to time after surgery. Multivariate logistic regression revealed no significant effect of time since surgery. Trends were seen with regard to age and type of operation, but did not reach significance. Patient-perceived benefit following ptosis surgery shows stability with time, as assessed using the GBI. Future studies could explore correlations with age and type of surgery.

  11. Validity and Reliability of Patient Reported Outcomes Measurement Information System Computerized Adaptive Tests in Systemic Lupus Erythematosus.

    PubMed

    Kasturi, Shanthini; Szymonifka, Jackie; Burket, Jayme C; Berman, Jessica R; Kirou, Kyriakos A; Levine, Alana B; Sammaritano, Lisa R; Mandl, Lisa A

    2017-07-01

    The aims of this study were to assess the construct validity and the test-retest reliability of Patient Reported Outcomes Measurement Information System (PROMIS) computerized adaptive tests (CAT) in patients with systemic lupus erythematosus (SLE). Adults with SLE completed the Medical Outcomes Study Short Form-36, LupusQoL-US version ("legacy instruments"), and 14 selected PROMIS CAT. Using Spearman correlations, PROMIS CAT were compared with similar domains measured with legacy instruments. CAT were also correlated with the Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) disease activity and the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) scores. Test-retest reliability was evaluated using ICC. There were 204 outpatients with SLE enrolled in the study and 162 completed a retest. PROMIS CAT showed good performance characteristics and moderate to strong correlations with similar domains in the 2 legacy instruments (r = -0.49 to 0.86, p < 0.001). However, correlations between PROMIS CAT and the SELENA-SLEDAI disease activity and SDI were generally weak and statistically insignificant. PROMIS CAT test-retest ICC were good to excellent, ranging from 0.72 to 0.88. To our knowledge, these data are the first to show that PROMIS CAT are valid and reliable for many SLE-relevant domains. Importantly, PROMIS scores did not correlate well with physician-derived measures. This disconnect between objective signs and symptoms and the subjective patient disease experience underscores the crucial need to integrate patient-reported outcomes into clinical care to ensure optimal disease management.

  12. 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…

  13. 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…

  14. Intercentre variance in patient reported outcomes is lower than objective rheumatoid arthritis activity measures: a cross-sectional study.

    PubMed

    Khan, Nasim Ahmed; Spencer, Horace Jack; Nikiphorou, Elena; Naranjo, Antonio; Alten, Rieki; Chirieac, Rodica M; Drosos, Alexandros A; Géher, Pál; Inanc, Nevsun; Kerzberg, Eduardo; Ancuta, Codrina Mihaela; Müller, Rüediger; Ørnbjerg, Lykke; Sokka, Tuulliki

    2017-08-01

    To assess intercentre variability in the ACR core set measures, DAS28 based on three variables (DAS28v3) and Routine Assessment of Patient Index Data 3 in a multinational study. Seven thousand and twenty-three patients were recruited (84 centres; 30 countries) using a standard protocol in the Quantitative Standard Monitoring of Patients with RA study. Analysis of variance (ANOVA) and mixed-effect analysis of covariance models were used to model the relationship between study centre and different patient-reported and physician-reported RA activity measures. These models were built to adjust for the remaining ACR core set measure (for each ACR core set measure or each composite index), socio-demographics and medical characteristics. ANOVA and analysis of covariance models yielded similar results, and ANOVA tables were used to present variance attributable to recruiting centre. The proportion of variances attributable to recruiting centre was lower for patient reported outcomes (PROs: pain, HAQ, patient global) compared with objective measures (joint counts, ESR, physician global) in all models. In the full model, variance in PROs attributable to recruiting centre ranged from 1.53% for patient global to 3.71% for HAQ compared with objective measures that ranged from 5.92% for physician global to 9.25% for ESR; and was lower for Routine Assessment of Patient Index Data 3 (2.6%) compared with DAS28v3 (11.75%). Intercentre variability in PROs is lower than objective measures of RA activity demonstrating that PROs may be more comparable across centres, and the need for standardization of objective measures.

  15. Patient-Reported Outcome Measures for Hand and Wrist Trauma: Is There Sufficient Evidence of Reliability, Validity, and Responsiveness?

    PubMed

    Dacombe, Peter Jonathan; Amirfeyz, Rouin; Davis, Tim

    2016-03-01

    Patient-reported outcome measures (PROMs) are important tools for assessing outcomes following injuries to the hand and wrist. Many commonly used PROMs have no evidence of reliability, validity, and responsiveness in a hand and wrist trauma population. This systematic review examines the PROMs used in the assessment of hand and wrist trauma patients, and the evidence for reliability, validity, and responsiveness of each measure in this population. A systematic review of Pubmed, Medline, and CINAHL searching for randomized controlled trials of patients with traumatic injuries to the hand and wrist was carried out to identify the PROMs. For each identified PROM, evidence of reliability, validity, and responsiveness was identified using a further systematic review of the Pubmed, Medline, CINAHL, and reverse citation trail audit procedure. The PROM used most often was the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire; the Patient-Rated Wrist Evaluation (PRWE), Gartland and Werley score, Michigan Hand Outcomes score, Mayo Wrist Score, and Short Form 36 were also commonly used. Only the DASH and PRWE have evidence of reliability, validity, and responsiveness in patients with traumatic injuries to the hand and wrist; other measures either have incomplete evidence or evidence gathered in a nontraumatic population. The DASH and PRWE both have evidence of reliability, validity, and responsiveness in a hand and wrist trauma population. Other PROMs used to assess hand and wrist trauma patients do not. This should be considered when selecting a PROM for patients with traumatic hand and wrist pathology.

  16. Danish translation of a physical function item bank from the Patient-Reported Outcome Measurement Information System (PROMIS).

    PubMed

    Schnohr, Christina W; Rasmussen, Charlotte L; Langberg, Henning; Bjørner, Jakob B

    2017-01-01

    The Patient-Reported Outcome Measurement Information System (PROMIS) is an assessment system that aims to provide more valid, reliable, responsive, and precise patient-reported outcome (PRO) measures than has been previously available. This paper documents the translation of the Physical Function item bank into Danish. We followed the PROMIS standard procedure, including: 1) two independent translations, 2) back translation, 3) independent reviews of translation quality, and 4) cognitive interviews with a representative sample of the adult population from the municipality of Copenhagen. After each phase, the new information was reviewed and the Danish version of the PROMIS Physical Function items was revised, if warranted. Relatively few problems were related to translation in itself and such problems could be fixed by changes in item wordings to fit the Danish context. Cognitive testing revealed problem of a general issue: annoyance in case of mismatch between respondents' functional level and question difficulty, problems imagining performance on activities that the respondents did not usually do, and uncertainty whether mobility aids (e.g., canes and walkers) should be considered when performing an activity. Solutions to the more general issues would require revisions to the original items. The standard translation methodology was successful in eliminating problems in translation, and pointed to problems of a general issue in some of the original questions, producing translated Danish versions of the PROMIS Physical Functioning items. Translation and validation studies provide a valuable source when revising and improving PROs in a clinical setting or for research. The present paper exemplifies this with experiences from Denmark. The study describes how the use of PROs when measuring physical functioning in a Danish context can be improved-hence improving the items used for research, future trials and in clinical settings.

  17. Development and Validation of Patient-Reported Outcome Measures for Sleep Disturbance and Sleep-Related Impairments

    PubMed Central

    Buysse, Daniel J.; Yu, Lan; Moul, Douglas E.; Germain, Anne; Stover, Angela; Dodds, Nathan E.; Johnston, Kelly L.; Shablesky-Cade, Melissa A.; Pilkonis, Paul A.

    2010-01-01

    Study Objectives: To develop an archive of self-report questions assessing sleep disturbance and sleep-related impairments (SRI), to develop item banks from this archive, and to validate and calibrate the item banks using classic validation techniques and item response theory analyses in a sample of clinical and community participants. Design: Cross-sectional self-report study. Setting: Academic medical center and participant homes. Participants: One thousand nine hundred ninety-three adults recruited from an Internet polling sample and 259 adults recruited from medical, psychiatric, and sleep clinics. Interventions: None. Measurements and Results: This study was part of PROMIS (Patient-Reported Outcomes Information System), a National Institutes of Health Roadmap initiative. Self-report item banks were developed through an iterative process of literature searches, collecting and sorting items, expert content review, qualitative patient research, and pilot testing. Internal consistency, convergent validity, and exploratory and confirmatory factor analysis were examined in the resulting item banks. Factor analyses identified 2 preliminary item banks, sleep disturbance and SRI. Item response theory analyses and expert content review narrowed the item banks to 27 and 16 items, respectively. Validity of the item banks was supported by moderate to high correlations with existing scales and by significant differences in sleep disturbance and SRI scores between participants with and without sleep disorders. Conclusions: The PROMIS sleep disturbance and SRI item banks have excellent measurement properties and may prove to be useful for assessing general aspects of sleep and SRI with various groups of patients and interventions. Citation: Buysse DJ; Yu L; Moul DE; Germain A; Stover A; Dodds NE; Johnston KL; Shablesky-Cade MA; Pilkonis PA. Development and validation of patient-reported outcome measures for sleep disturbance and sleep-related impairments. SLEEP 2010

  18. Hand-related physical function in rheumatic hand conditions: a protocol for developing a patient-reported outcome measurement instrument

    PubMed Central

    Klokker, Louise; Terwee, Caroline B; Wæhrens, Eva Ejlersen; Henriksen, Marius; Nolte, Sandra; Liegl, Gregor; Kloppenburg, Margreet; Westhoven, Rene; Wittoek, Ruth; Kjeken, Ingvild; Haugen, Ida K; Schalet, Ben; Gershon, Richard; Bliddal, Henning

    2016-01-01

    Introduction There is no consensus about what constitutes the most appropriate patient-reported outcome measurement (PROM) instrument for measuring physical function in patients with rheumatic hand conditions. Existing instruments lack psychometric testing and vary in feasibility and their psychometric qualities. We aim to develop a PROM instrument to assess hand-related physical function in rheumatic hand conditions. Methods and analysis We will perform a systematic search to identify existing PROMs to rheumatic hand conditions, and select items relevant for hand-related physical function as well as those items from the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) item bank that are relevant to patients with rheumatic hand conditions. Selection will be based on consensus among reviewers. Content validity of selected items will be established through the use of focus groups. If patients deem necessary, we will develop new items based on the patients' input. We will examine whether it is valid to score all selected and developed items on the same scale as the original items from the PROMIS PF item bank. Our analyses will follow the methods used for calibrating the original PROMIS PF item bank in US samples, which were largely based on the general PROMIS approach. Ethics and dissemination This study will be carried out in accordance with the Helsinki Declaration. Ethics approvals will be obtained where necessary, and signed informed consent will be obtained from all participants. We aim to disseminate the results of the study through publication in international peer-reviewed journals and at international conferences. PMID:27974367

  19. U.S. Dental School Deans' Views on the Value of Patient-Reported Outcome Measures in Dentistry.

    PubMed

    Rosen, Evan B; Donoff, R Bruce; Riedy, Christine A

    2016-06-01

    There has historically been limited development and utilization of patient-reported outcome measures (PROMs) in clinical dentistry. However, in recent years PROMs have been recognized by other health care fields as valuable in the comprehensive assessment of patient outcomes. The aim of this study was to survey deans of U.S. dental schools to better understand their vision for the role of PROMs in the field of dentistry. A 13-question online survey was emailed to the deans of the 64 accredited U.S. dental schools at the time to gather their opinions about the value of patient-reported outcomes in dentistry. The survey consisted of questions in 12 domains such as treatment planning, perceived success/complications of surgery, identification/management of dental pain, psychological and oral function, and insurance payment/reimbursement. Of the 64 deans, 33 responses were received (51.5% response rate), but three surveys were excluded due to incomplete answers, resulting in a final response rate of 46.8%. All respondents reported there was value in utilization of PROMs for understanding a patient's satisfaction of a procedure, a patient's perceived success of dental surgery, identifying dental pain, and managing dental pain. However, there was disagreement among the respondents about utilization of PROMs for the purpose of determining insurance payment and/or reimbursement. Additional steps should be taken to develop clinically appropriate PROMs for dentistry and to determine the appropriate situations in which to use dental PROMs. This study suggests that PROMs should be incorporated into dental school curricula as they will likely play a role in future comprehensive treatment assessment.

  20. Revision rhinoplasty: measurement of patient-reported outcomes and analysis of predictive factors.

    PubMed

    Abbas, Ozan Luay

    2016-01-01

    Considering that revision rhinoplasty is one of the most difficult plastic surgical procedures, evaluating patient satisfaction is fundamental in order to determine success and identify variables that may affect the outcomes. Our first study objective was to determine satisfaction levels in revision patients and to compare results with those obtained in primary rhinoplasty patients. Second, we sought to identify factors that may influence the degree of satisfaction. Satisfaction was evaluated in 54 revision and 54 primary rhinoplasty patients using the rhinoplasty outcome evaluation questionnaire. To identify associated factors, patients were assessed for demographic characteristics, medical history, follow-up time, reason for revision, graft usage, the severity of nasal deformity, and satisfaction with the provided care and information given before the surgery. All revision and primary rhinoplasty patients experienced improvements in satisfaction scores. Although the improvements were higher in primary rhinoplasty patients, the levels obtained in revision patients can be considered high. We found that young and male patients tend to have less satisfaction increment after the surgery. Patients who underwent revision for aesthetic reasons had higher improvements in satisfaction scores when compared to those patients who underwent revision for a combination of aesthetic and functional reasons. The improvement in satisfaction scores in patients who were satisfied with the information given before surgery was higher. Our data suggest that significant patient satisfaction is achieved after revision rhinoplasty and highlight the importance of the informed consent process when planning revision, especially on young and male patients. III.

  1. Addressing Missing Data in Patient-Reported Outcome Measures (PROMS): Implications for the Use of PROMS for Comparing Provider Performance.

    PubMed

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

    2016-05-01

    Patient-reported outcome measures (PROMs) are now routinely collected in the English National Health Service and used to compare and reward hospital performance within a high-powered pay-for-performance scheme. However, PROMs are prone to missing data. For example, hospitals often fail to administer the pre-operative questionnaire at hospital admission, or patients may refuse to participate or fail to return their post-operative questionnaire. A key concern with missing PROMs is that the individuals with complete information tend to be an unrepresentative sample of patients within each provider and inferences based on the complete cases will be misleading. This study proposes a strategy for addressing missing data in the English PROM survey using multiple imputation techniques and investigates its impact on assessing provider performance. We find that inferences about relative provider performance are sensitive to the assumptions made about the reasons for the missing data.

  2. Patient Reported Outcomes and Fibromyalgia

    PubMed Central

    Williams, David A.; Kratz, Anna L.

    2016-01-01

    Fibromyalgia (FM) is classified as a chronic pain condition accompanied by symptoms of fatigue, sleep problems, problems with cognition, negative mood, limited functional status, and the presence of other chronic overlapping pain conditions (COPCs). Comprehensive assessment of all of these components can be challenging. This paper provides an overview of patient-reported approaches that can be taken to assess FM in the contexts of diagnosis, symptom monitoring, phenotyping/characterization, and for purposes of clinical trials. PMID:27133492

  3. Preoperative Performance of the Patient-Reported Outcomes Measurement Information System in Patients With Rotator Cuff Pathology.

    PubMed

    Anthony, Chris A; Glass, Natalie; Hancock, Kyle; Bollier, Matt; Hettrich, Carolyn M; Wolf, Brian R

    2017-10-01

    To evaluate the Patient-Reported Outcomes Measurement Information System upper extremity item bank (PROMIS UE) and physical function computerized adaptive test (PROMIS PF CAT) in patients with rotator cuff (RC) pathology at their preoperative clinic visit. Patient data were collected from January 2015 to September 2015. Patients with a preoperative diagnosis of RC pathology were prospectively enrolled at the time of their surgical indication for RC repair. Each patient was asked to fill out the Western Ontario Rotator Cuff Index (WORC), American Shoulder and Elbow Surgeons Shoulder Assessment Form, Marx Shoulder Activity Scale, Short Form 36 Health Survey Physical Function and General Health (SF-36 PF and GH), EuroQol-5 Dimension (EQ-5D), PROMIS PF CAT, and PROMIS UE. Correlation was defined as excellent (>0.7), excellent-good (0.61-0.7), good (0.4-0.6), and poor (0.2-0.3). Patient data were collected from January 2015 to September 2015. No patients were excluded from participation in the study. In 82 patients with preoperative RC pathology, the PROMIS UE showed excellent correlation with American Shoulder and Elbow Surgeons Shoulder Assessment Form (r = 0.77, P < .01), WORC (r = 0.73, P < .01), and the EQ-5D (r = 0.73, P < .01); there was excellent-good correlation with the SF-36 PF (r = .66, P < .01) and PROMIS PF CAT (r = .70, P < .01). The PROMIS PF CAT showed excellent correlation with the SF-36 PF (r = 0.77, P < .01); there was excellent-good correlation with EQ-5D (r = 0.65, P < .01) and WORC (r = 0.61, P < .01). There were no significant floor or ceiling effects using the PROMIS UE item bank or PROMIS PF CAT. We report that in a patient population with preoperative RC pathology, the PROMIS UE and PROMIS CAT are valid patient-reported outcome alternatives that have high correlation with traditional shoulder and upper extremity patient-reported outcomes. We find a decreased question burden using the PROMIS PF CAT. We find no significant floor or

  4. An experience with the Patient-Reported Outcomes Measurement Information System: pros and cons and unanswered questions.

    PubMed

    Badger, Terry A; Heitkemper, Margaret; Lee, Kathryn A; Bruner, Deborah Watkins

    2014-01-01

    The goal of the Patient-Reported Outcomes Measurement Information System (PROMIS) is to create efficient, reliable, and valid assessments of adult and child health. The nursing science literature in which PROMIS measures are used is rapidly expanding. Investigators have been encouraged to consider the integration of PROMIS measures into both descriptive studies and clinical trials. Doing this has created opportunities and challenges for investigators. This article highlights three projects to show the perspectives of nurse scientists who incorporated PROMIS measures into their research. The first project describes advantages of PROMIS to allow for comparisons of a study population with a national sample and to compliment legacy measures. The second project examines issues in the translation of tools for region-specific Hispanic populations. The third project provides a perspective on the use of PROMIS measures to capture cancer-related fatigue and to develop new components of a sexual function scale. As indicated by these three examples, nurse scientists can contribute an important role in moving the PROMIS initiative forward. Results from these types of projects also move symptom science forward within a more interdisciplinary approach to common measures of interest.

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

    PubMed

    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 Mr

    2014-02-01

    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. 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). 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. 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.

  6. Hyperbaric oxygen therapy for late radiation-induced tissue toxicity: prospectively patient-reported outcome measures in breast cancer patients.

    PubMed

    Teguh, David N; Bol Raap, René; Struikmans, Henk; Verhoef, Cees; Koppert, Linetta B; Koole, Arne; Huang, Yadi; van Hulst, Rob A

    2016-09-29

    This study examines patient reported outcome measures of women undergoing hyperbaric oxygen treatment (HBOT) after breast-conserving therapy. Included were 57 women treated with HBOT for late radiation-induced tissue toxicity (LRITT) referred in the period January 2014-December 2015. HBOT consisted of (on average) 47 sessions. In total, 80 min of 100 % O2 was administered under increased pressure of 2.4 ATA. Quality of life was assessed before and after treatment using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-BR23, and a NRS pain score. Fifty-seven women were available for evaluation before and after treatment. Before HBOT, patients had severe complaints of pain in the arm/shoulder (46 %), swollen arm/hand (14 %), difficulty to raise arm or move it sideways (45 %), pain in the area of the affected breast (67 %), swollen area of the affected breast (45 %), oversensitivity of the affected breast (54 %), and skin problems on/in the area of the affected breast (32 %); post HBOT, severe complaints were still experienced in 17, 7, 22, 15, 13, 15, and 11 % of the women, respectively. Differences were all significant. The NRS pain score improved at least 1 point (range 0-10) in 81 % of the patients (p < 0.05). In these breast cancer patients treated with HBOT for LRITT, the patient-reported outcomes were positive and improvements were observed. HBOT was a well-tolerated treatment for LRITT and its side-effects were both minimal and reversible.

  7. Comparison of Rating Scales in the Development of Patient-Reported Outcome Measures for Children with Eye Disorders.

    PubMed

    Hatt, Sarah R; Leske, David A; Wernimont, Suzanne M; Birch, Eileen E; Holmes, Jonathan M

    2017-03-01

    A rating scale is a critical component of patient-reported outcome instrument design, but the optimal rating scale format for pediatric use has not been investigated. We compared rating scale performance when administering potential questionnaire items to children with eye disorders and their parents. Three commonly used rating scales were evaluated: frequency (never, sometimes, often, always), severity (not at all, a little, some, a lot), and difficulty (not difficult, a little difficult, difficult, very difficult). Ten patient-derived items were formatted for each rating scale, and rating scale testing order was randomized. Both child and parent were asked to comment on any problems with, or a preference for, a particular scale. Any confusion about options or inability to answer was recorded. Twenty-one children, aged 5-17 years, with strabismus, amblyopia, or refractive error were recruited, each with one of their parents. Of the first 10 children, 4 (40%) had problems using the difficulty scale, compared with 1 (10%) using frequency, and none using severity. The difficulty scale was modified, replacing the word "difficult" with "hard." Eleven additional children (plus parents) then completed all 3 questionnaires. No children had problems using any scale. Four (36%) parents had problems using the difficulty ("hard") scale and 1 (9%) with frequency. Regarding preference, 6 (55%) of 11 children and 5 (50%) of 10 parents preferred using the frequency scale. Children and parents found the frequency scale and question format to be the most easily understood. Children and parents also expressed preference for the frequency scale, compared with the difficulty and severity scales. We recommend frequency rating scales for patient-reported outcome measures in pediatric populations.

  8. 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

  9. Responsiveness of three Patient Report Outcome (PRO) measures in patients with hand fractures: A preliminary cohort study.

    PubMed

    Weinstock-Zlotnick, Gwen; Page, Carol; Ghomrawi, Hassan M K; Wolff, Aviva L

    2015-01-01

    Clinical measurement. Few studies describe the responsiveness of functional outcomes measures in patients sustaining hand fractures. 1--To explore the responsiveness of three function-oriented Patient Report Outcome (PRO) measures with a cohort of hand fracture patients. 2--To examine patients' PRO preference. 60 participants with 74 hand fractures at an outpatient hospital-based hand therapy clinic consented to participate in this study. They completed the Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH), Michigan Hand Outcomes Questionnaire (MHQ), and Patient-Rated Wrist/Hand Evaluation (PRWHE) at three trials: T1 (evaluation), T2 (one month later), and T3 (two months later). Participants also identified which PRO they felt best reflected their hand use and which was easiest to complete. Descriptive statistics, analyses of variance (ANOVA), effect size, and standardized response mean (SRM) were employed to describe participants, determine functional change between trials, and examine and compare PRO responsiveness. Questionnaire preference at T1 was reported. Participants demonstrated functional improvement, as measured by the DASH, PRWHE, and MHQ. T1 scores: DASH = 41.85 (SD ± 22.78), MHQ = 50.13 (SD ± 18.36), and PRWHE = 48.18 (SD ± 22.07). T2 scores: DASH = 22.11 (SD ± 18.18), MHQ = 69.89 (SD ± 15.93), and PRWHE = 22.62 (SD ± 18.15). T3 scores: DASH = 17.56 (SD ± 18.01), MHQ = 75.37 (SD ± 19.19), and PRWHE = 22.40 (SD ± 19.04). Each PRO demonstrated significant test score differences between trials (p < .001). Large responsiveness (≥.80) was noted between T1 and T2: (effect size: .98-1.23; SRM: 1.31-1.49) and T1 and T3 (effect size: 1.21-1.54; SRM 1.49-1.84). Smaller responsiveness effects were noted between T2 and T3 (effect size: .35-.64, SRM: .38-.81). No significant differences between questionnaire responsiveness were found. Patients reported PRWHE easiest to complete and MHQ best reflecting their hand use. DASH, MHQ, and PRWHE

  10. 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.

  11. Norfolk QOL-DN: validation of a patient reported outcome measure in transthyretin familial amyloid polyneuropathy.

    PubMed

    Vinik, Etta J; Vinik, Aaron I; Paulson, James F; Merkies, Ingemar S J; Packman, Jeff; Grogan, Donna R; Coelho, Teresa

    2014-06-01

    The Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN) questionnaire is an instrument to assess QOL in diabetic polyneuropathy. The objective of this observational, cross-sectional study in 61 patients with V30M transthyretin familial amyloid polyneuropathy (TTR-FAP) and 16 healthy volunteers was to validate the Norfolk QOL-DN for assessment of QOL in TTR-FAP. Comparisons were conducted to identify the best items to discriminate disease stages and assess which individual Norfolk domains (symptoms, large fiber, small fiber, autonomic, and activities of daily living) would be most affected by disease stage. Analysis of individual items revealed a significant pattern of discrimination among disease stages (p < 0.001). Total QOL scores increased (indicating worsening) with duration of symptoms, with a steeper increase observed earlier in the course of disease. Significant correlations were observed between each Norfolk domain and other measures of neurological function. Limitations include cross-sectional study design, low patient numbers in this rare disease, and the ordinal-based character of the metric used; future areas to explore include item response theory approaches such as Rasch analysis. These results suggest the Norfolk QOL-DN is a reliable indicator of the impact of disease severity on QOL in patients with TTR-FAP. © 2014 Peripheral Nerve Society.

  12. 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

  13. Enhancing patient-reported outcome measurement in research and practice of palliative and end-of-life care.

    PubMed

    Simon, Steffen T; Higginson, Irene J; Harding, Richard; Daveson, Barbara A; Gysels, Marjolein; Deliens, Luc; Echteld, Michael A; Radbruch, Lukas; Toscani, Franco; Krzyzanowski, Dominik M; Costantini, Massimo; Downing, Julia; Ferreira, Pedro L; Benalia, Abdelhamid; Bausewein, Claudia

    2012-07-01

    Patient-reported outcome measurement (PROM) plays an increasing role in palliative and end-of-life (EOL) care but their use in EOL care and research remains varied and inconsistent. We aimed to facilitate pan-European collaboration to improve PROMs in palliative and EOL care and research. The study includes a workshop with experts experienced in using PROMs in clinical care and research from Europe, North America, and Africa. Information from presentations, and plenary and group discussions was analysed using content analysis for extracting the main themes. Thirty-two professionals from 15 countries and eight different professional backgrounds participated in the workshop. The discussion identified: 1) the need for standardisation with improvement of existing PROMs, e.g., with a modular system and an optional item pool; 2) the aspects of further development with a multi-professional approach taking into account cultural sensitivity especially for translated versions; and 3) the need for guidance, training, and resources. An international network for sharing concepts, experiences, and solutions could enhance these steps of further development. PROMs must be based on rigorous scientific methods and respond to patient complexity. Coordinated pan-European collaboration including researchers and clinicians is required to develop and attain quality care and systematic research in outcome measurement in palliative and EOL care.

  14. DEVELOPMENT AND VALIDATION OF 'SURE': A PATIENT REPORTED OUTCOME MEASURE (PROM) FOR RECOVERY FROM DRUG AND ALCOHOL DEPENDENCE.

    PubMed

    Neale, Joanne; Vitoratou, Silia; Finch, Emily; Lennon, Paul; Mitcheson, Luke; Panebianco, Daria; Rose, Diana; Strang, John; Wykes, Til; Marsden, John

    2016-08-01

    Patient Reported Outcome Measures (PROMs) assess health status and health-related quality of life from the patient/service user perspective. Our study aimed to: i. develop a PROM for recovery from drug and alcohol dependence that has good face and content validity, acceptability and usability for people in recovery; ii. evaluate the psychometric properties and factorial structure of the new PROM ('SURE'). Item development included Delphi groups, focus groups, and service user feedback on draft versions of the new measure. A 30-item beta version was completed by 575 service users (461 in person [IP] and 114 online [OL]). Analyses comprised rating scale evaluation, assessment of psychometric properties, factorial structure, and differential item functioning. The beta measure had good face and content validity. Nine items were removed due to low stability, low factor loading, low construct validity or high complexity. The remaining 21 items were re-scaled (Rasch model analyses). Exploratory and confirmatory factor analyses revealed 5 factors: substance use, material resources, outlook on life, self-care, and relationships. The MIMIC model indicated 95% metric invariance across the IP and OL samples, and 100% metric invariance for gender. Internal consistency and test-retest reliability were granted. The 5 factors correlated positively with the corresponding WHOQOL-BREF and ARC subscales and score differences between participant sub-groups confirmed discriminative validity. 'SURE' is a psychometrically valid, quick and easy-to-complete outcome measure, developed with unprecedented input from people in recovery. It can be used alongside, or instead of, existing outcome tools. Copyright © 2016 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

  15. 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

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

    PubMed

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

    2016-01-01

    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). 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. 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. 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.

  17. Inclusion of patient-reported outcome measures in registered clinical trials: Evidence from ClinicalTrials.gov (2007-2013).

    PubMed

    Vodicka, E; Kim, K; Devine, E B; Gnanasakthy, A; Scoggins, J F; Patrick, D L

    2015-07-01

    Patient reported outcomes (PROs) have gained a prominent place in clinical research. Previous estimates suggest that PRO measures are used in 14% of clinical trials. Online registries, such as ClinicalTrials.gov, may be useful in evaluating extent of PRO use. To estimate the proportion of clinical trials using at least one PRO measure and to examine associations between trial characteristics and use of PRO measures. A copy of the ClinicalTrials.gov database was made, containing all data from November 2007 to December 2013. Content was searched for use of PRO measures. Multivariable logistic regression was used to investigate possible associations between trial-level characteristics and use of PRO measures. Of 96,736 registered trials, 26,337 (27%) were identified as using one or more PRO measures. Among oncology trials, 29% (3947/13,584) were identified as using a PRO measure, compared to 27% (22,390/83,152) of non-oncology trials. A greater proportion of trials using PRO measures were more likely to be sponsored by university/research organizations (29%) or the US government (33%), compared to industry (22%); Phase III (35%); non-randomized (32%); and evaluating devices (30%), procedures (31%) or behaviors (50%), compared to drugs (24%). Fewer were FDA-regulated (23%). Evidence suggests that between 2007 and 2013, there has been an increase in the number of trials that use a PRO measure, particularly in oncology trials. With initiatives such as the Patient-Focused Drug Development and FDA PRO Guidance, the trend in the use of PRO measures in clinical research will likely increase further. Copyright © 2015 Elsevier Inc. All rights reserved.

  18. 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.

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

    PubMed

    Deng, Nina; Allison, Jeroan J; Fang, Hua Julia; Ash, Arlene S; Ware, John E

    2013-05-31

    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. 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. 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. 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).

  20. 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

  1. Integrated care pathways for cancer survivors - a role for patient-reported outcome measures and health informatics.

    PubMed

    Warrington, Lorraine; Absolom, Kate; Velikova, Galina

    2015-05-01

    Modern cancer treatments have improved survival rates and changed the nature of cancer care. The acute and long-term physical and psychosocial comorbidities associated with treatment place increasing demands on healthcare services to provide suitable models of follow-up care for the survivor population. We discuss the value and challenges of incorporating patient-reported outcome measures (PROMs) and eHealth interventions into routine follow-up care. We draw on our 15 years' experience of developing electronic systems for capturing patient-reported data in oncology settings, with particular reference to eRAPID a new online symptom reporting system for cancer patients. THE REDESIGN OF HEALTHCARE PATHWAYS: New stratified care pathways have been proposed for cancer survivors with an emphasis on supported self-management and shared care. THE POTENTIAL ROLE OF PROMS IN SURVIVORSHIP CARE PATHWAYS: PROMs can be used to evaluate rehabilitation services, provide epidemiological 'Big Data' and screen patients for physical and psychological morbidities to determine the need for further support. In addition, electronic PROMs systems linked to electronic patient records (EPRs) have the capability to provide tailored self-management advice to individual patients. INTEGRATION OF PROMS INTO CLINICAL PRACTICE: The successful clinical utilisation of PROMs is dependent on a number of components including; choosing appropriate questionnaires, developing evidence-based scoring algorithms, the creation of robust electronic platforms for recording and transferring data into EPRs, and training staff and patients to engage effectively with PROMs. There is increasingly positive evidence for using PROMs and eHealth approaches to support cancer patients' care during treatment. Much of what has been learnt can be applied to cancer survivorship. PROMs integrated into eHealth platforms and with EPR have the potential to play a valuable role in the development of appropriate and sustainable long

  2. Development of a new patient-reported outcome measure for facial acne: the Acne Symptom and Impact Scale (ASIS).

    PubMed

    Alexis, Andrew; Daniels, Selena R; Johnson, Nathan; Pompilus, Farrah; Burgess, Somali Misra; Harper, Julie C

    2014-03-01

    Facial acne has been associated with impaired health-related quality of life, which is an essential patient outcome for evaluating the success of acne treatment. In consideration of the US Food and Drug Administration's (FDA) new recommendations on patient reported outcome (PRO) measures, the objectives of this study were to (1) establish the need for a new PRO measure that assesses facial acne outcomes and satisfies the criteria set forth by the FDA and (2) develop the content of a new facial acne PRO measure appropriate for use in both adolescents and adults as well as adherent to the FDA PRO Guidance. A literature and PRO review, patient interviews (concept elicitation), and input from clinical experts were used to develop a conceptual framework for the outcomes deemed important to facial acne patients, and to construct items for a preliminary PRO measure: the Acne Symptom and Impact Scale (ASIS). Cognitive interviews were conducted to pilot test the ASIS. A review of the literature and PROs revealed that, of the 34 measures identified, no suitable PRO measure for the population of interest was available. The conceptual framework comprised two main themes: symptoms and psychosocial impacts. Concept elicitation interviews included a diverse set of patients (n=48) with facial acne, of various ages: 12-17 years (n=15), 18-25 years (n=20), and 26-50 years (n=13). The most frequently reported symptoms were: pimples, oily skin, scabs/scars/marks, blackheads, acne, and whiteheads. The most frequently reported impacts were impacts on appearance, self-consciousness, annoyance, bothersomeness, mood, social criticism, embarrassment, confidence, and social withdrawal. These reported symptoms and impacts constituted the 15-item draft ASIS. The draft ASIS was modified following the analysis of 20 cognitive interviews, resulting in the current 17-item ASIS. Results from both the concept elicitation and cognitive interviews demonstrated that the ASIS is content valid in both

  3. Validating English- and Spanish-language patient-reported outcome measures in underserved patients with rheumatic disease

    PubMed Central

    2011-01-01

    Introduction Rheumatic diseases are among the most common and debilitating health problems in the United States. These diseases are chronic, can result in severe decrements of physical and psychosocial functioning and affect patients' overall quality of life. A consensus regarding the best patient outcomes to be measured in randomized, controlled trials and prospective natural history studies is essential to provide best estimates of efficacy and safety of interventions across diverse patient populations. Methods Face-to-face English- and Spanish-language cognitive interviews were conducted among urban Hispanic and African American patients with rheumatic disease to develop a questionnaire booklet. Six measures validating patient-reported outcomes were included: the Arthritis Self-Efficacy Scale, the Stanford Health Assessment Questionnaire Disability Index, the Wong-Baker Faces Pain Scale, the Short Acculturation Scale, the Center for Epidemiologic Studies Depression Scale and the Inventory of Complementary and Alternative Medicine Practices. A sample of patients (n = 15) attending the National Institute of Arthritis and Musculoskeletal and Skin Diseases Community Health Center participated in the initial interviews. Revised measures were further tested for reliability in a separate sample of patients (n = 109) upon enrollment at the health center. Results Cognitive interviews provided feedback for questionnaire modifications and methods to enhance content validity and data quality, including discarding redundant questions, providing visual aids and concrete examples when appropriate and increasing the use of racially and ethnically concordant interviewers. The cognitive interviews further elucidated that some contextual assumptions and language usage in the original questionnaires may not have taken each respondent's environmental and sociocultural context into consideration. Internal reliability for previously tested measures remained high (Cronbach's α = 0

  4. Systematic review of patient-reported outcome measures in the surgical treatment of patients with esophageal cancer.

    PubMed

    Straatman, J; Joosten, P J M; Terwee, C B; Cuesta, M A; Jansma, E P; van der Peet, D L

    2016-10-01

    Esophageal cancer is currently the eighth most common cancer worldwide. Improvements in operative techniques and neoadjuvant therapies have led to improved outcomes. Resection of the esophagus carries a high risk of severe complications and has a negative impact on health-related quality of life (QOL). The aim of this study was to assess which patient-reported outcome measures (PROMs) are used to measure QOL after esophagectomy for cancer. A comprehensive search of original articles was conducted investigating QOL after surgery for esophageal carcinoma. Two authors independently selected relevant articles, conducted clinical appraisal, and extracted data (PJ and JS). Out of 5893 articles, 58 studies were included, consisting of 41 prospective and 17 retrospective cohort studies, including a total of 6964 patients. These studies included 11 different PROMs. The existing PROMs could be divided into generic, symptom-specific, and disease-specific questionnaires. The European Organisation for Research and Treatment of Cancer (EORTC) QOL Questionnaire Core 30 (QLQ C-30) along with the EORTC QLQ-OESophagus module OES18 was the most widely used; in 42 and 32 studies, respectively. The EORTC and the Functional Assessment of Cancer Therapy (FACT) questionnaires use an oncological module and an organ-specific module. One validation study was available, which compared the FACT and EORTC, showing moderate to poor correlation between the questionnaires. A great variety of PROMs are being used in the measurement of QOL after surgery for esophageal cancer. A questionnaire with a general module along with a disease-specific module for assessment of QOL of different treatment modalities seem to be the most desirable, such as the EORTC and the FACT with their specific modules (EORTC QLQ-OES18 and FACT-E). Both are developed in different treatment modalities, such as in surgical patients. With regard to reproducibility of current results, the EORTC is recommended. © 2015

  5. 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.

  6. Patient-reported outcome measures in patients with peripheral arterial disease: a systematic review of psychometric properties.

    PubMed

    Poku, Edith; Duncan, Rosie; Keetharuth, Anju; Essat, Munira; Phillips, Patrick; Woods, Helen Buckley; Palfreyman, Simon; Jones, Georgina; Kaltenthaler, Eva; Michaels, Jonathan

    2016-11-24

    Peripheral arterial disease (PAD) is generally associated with considerable morbidity and reduced quality of life. Patient-reported outcome measures (PROMs) provide important information about the burden of disease and impact of treatment in affected patients. The objective of the review was to identify and appraise studies reporting the psychometric evaluation of PROMs administered to a specified population of patients with PAD with a view to recommending suitable PROMs. A systematic review of peer-reviewed English language articles was undertaken to identify primary studies reporting psychometric properties of PROMs in English-speaking patients with various stages of PAD. Comprehensive searches were completed up until January 2015. Study selection, data extraction and quality assessment were undertaken independently by at least two researchers. Findings were presented as tabular and narrative summaries based on accepted guidance. Psychometric evaluation of 6 generic and 7 condition-specific PROMs reported in 14 studies contributed data to the review. The frequently reported measure was the SF-36 (n = 11 studies); others included the Walking Impairment Questionnaire (n = 8 studies), EQ-5D (n = 5 studies) and the Vascular Quality of Life Questionnaire (n = 3 studies). Studies included a diverse PAD population and varied in methodology, including approach to validation of PROMs. Various PROMs have been validated in patients with PAD but no study provided evidence of a full psychometric evaluation in the patient population. Careful selection is required to identify reliable and valid PROMs to use in clinical and research settings.

  7. 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.

  8. An Electronic Patient-Reported Outcome Measures System in UK Chiropractic Practices: A Feasibility Study of Routine Collection of Outcomes and Costs.

    PubMed

    Newell, Dave; Diment, Emily; Bolton, Jenni E

    2016-01-01

    The purpose of this study was to test the feasibility of collecting valid and widely used health outcomes, including information concerning cost of care, using a Web-based patient-driven patient-reported outcome measure (PROM) collection process within a cohort of UK chiropractic practices. A Web-based PROM system (Care Response) was used. Patients with low back and neck pain were recruited from a group of chiropractic practices located in the United Kingdom. Information collected included demographic data, generic and condition-specific PROMs at the initial consultation and 90 days later, patient-reported experience measures, and additional health seeking to estimate costs of care. A group of 33 clinics provided information from a total of 1895 patients who completed baseline questionnaires with 844 (45%) completing the measures at 90-day follow-up. Subsequent outcomes suggest that more than 70% of patients improved over the course of treatment regardless of the outcome used. Using the baseline as a virtual counterfactual with respect to follow-up, we calculated quality-adjusted life years and the cost thereof resulting in a mean quality-adjusted life years gained of 0.8 with an average cost of £895 per quality-adjusted life year. Routine collection of PROMs, including information about cost, is feasible and can be achieved using an online system within a clinical practice environment. We describe a Web-based collection system and discuss the choice of measures leading to a comprehensive understanding of outcomes and costs in routine practice. Copyright © 2016 National University of Health Sciences. Published by Elsevier Inc. All rights reserved.

  9. Cross-cultural validation of a disease-specific patient-reported outcome measure for systemic lupus erythematosus in Canada.

    PubMed

    Bourré-Tessier, Josiane; Clarke, Ann E; Mikolaitis-Preuss, Rachel A; Kosinski, Mark; Bernatsky, Sasha; Block, Joel A; Jolly, Meenakshi

    2013-08-01

    The LupusPRO, a disease-targeted patient-reported outcome measure, was developed and validated in US patients with systemic lupus erythematosus (SLE). We report the results of the cross-cultural validation study of the English version of the LupusPRO among patients in Canada with SLE. The LupusPRO was administered to English-speaking Canadian patients with SLE. Demographic, clinical, and serological characteristics were obtained, and the Medical Outcomes Study Short Form-36 (SF-36) and LupusPRO were administered. Disease activity was ascertained using the Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) and the Lupus Foundation of America definition of flare (Yes/No). Damage was assessed using the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI). Physician disease activity and damage assessments were also ascertained using visual analog scales. A mail-back LupusPRO form was completed within 2-3 days of the index visit. Items tested were internal consistency reliability (ICR), test-retest reliability (TRT), convergent and discriminant validity (against corresponding domains of the SF-36), criterion validity (against disease activity or health status), and known-groups validity. Participants were 123 Canadian patients with SLE (94% women); mean age was 47.7 (SD 14.8) years. The median (interquartile range) SELENA-SLEDAI and SDI were 4 (6) and 1 (3), respectively. The ICR of the LupusPRO domains ranged from 0.60 to 0.93, while the TRT range was 0.62-0.95. Measures observed were convergent and discriminant validity with corresponding domains of SF-36, criterion validity, and known-groups validity against disease activity, damage, and health status. Confirmatory factor analysis showed a good fit. The LupusPRO has fair psychometric properties among Canadian patients with SLE, and prospective studies to establish minimally important

  10. Impact of certolizumab pegol on patient-reported outcomes in rheumatoid arthritis and correlation with clinical measures of disease activity.

    PubMed

    Pope, Janet; Bingham, Clifton O; Fleischmann, Roy M; Dougados, Maxime; Massarotti, Elena M; Wollenhaupt, Jürgen; Duncan, Benjamin; Coteur, Geoffroy; Weinblatt, Michael E

    2015-11-27

    The effect of certolizumab pegol (CZP) on patient-reported outcomes (PROs) was investigated in 1063 patients with rheumatoid arthritis (RA) from the REALISTIC trial (double-blind, placebo-controlled to week 12, open-label to week 28; randomized 4:1 [CZP:placebo]). Correlations between PROs and RA signs and symptoms, and the relative efficacy of these measures, were examined. Adults with RA and an inadequate response to at least one disease-modifying antirheumatic drug were enrolled. PROs assessed included physical function (using the Health Assessment Questionnaire-Disability Index), pain, fatigue, sleep disturbance, Patient Global Assessment of Disease Activity (PtGA), Routine Assessment of Patient Index Data 3 (RAPID3), and Rheumatoid Arthritis Disease Activity Index (RADAI). Early significant and clinically meaningful improvements in all PROs were observed to week 12 with CZP vs. placebo and were maintained to the end of the trial (week 28). At week 12, up to one-third more CZP patients showed improvements compared with placebo that were greater than or equal to the minimal clinically important difference (MCID) in fatigue, sleep problems, pain, PtGA, RADAI, and RAPID3. The changes in PROs were correlated with clinical measures of disease activity, including the Disease Activity Score in 28 joints using C-reactive protein as well as tender and swollen joint counts. Rapid improvements in PROs were seen in patients with RA treated with CZP. The magnitude of improvement exceeded the MCID in multiple domains and demonstrated that CZP improves aspects of health-related quality of life that are meaningful to patients and superior to placebo. PROs provide information complementary to clinical outcomes in assessment of treatment benefits. ClinicalTrials.gov identifier: NCT00717236 . Registered on 15 July 2008.

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

    PubMed

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

    2017-01-01

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

  12. Cognitive Interviewing in the Evaluation of Fatigue Items: Results from the Patient-Reported Outcomes Measurement Information System (PROMIS)

    PubMed Central

    Christodoulou, Christopher; Junghaenel, Doerte U.; DeWalt, Darren A.; Rothrock, Nan; Stone, Arthur A.

    2010-01-01

    Objectives Cognitive Interviewing (CI) is a technique increasingly used to obtain respondent feedback on potential items during questionnaire development. No standard guidelines exist by which to incorporate CI feedback in deciding to retain, revise, or eliminate potential items. We used CI in developing fatigue items for the National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Roadmap initiative. Our aims were to describe the CI process, formally evaluate the utility of decisions made on the basis of CI, and offer suggestions for future research. Methods Participants were 22 patients with a diverse range of chronic health conditions. During CI, each participant provided feedback on a series of items. We then reviewed the CI data and decided whether to retain, revise, or eliminate each potential item. Following this, we developed or adopted three quantitative methods to compare retained versus eliminated items. Results Retained items raised fewer serious concerns, were less likely to be viewed as non-applicable, and were less likely to display problems with clarity or to make incorrect assumptions about respondents. Conclusions CI was useful in developing the PROMIS fatigue items and the methods used to judge CI for the present item set may be useful for future investigations. PMID:18850327

  13. 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.

  14. Content Validity of Patient-Reported Outcomes Measurement Information System (PROMIS) Items in the Context of HIV Clinical Care

    PubMed Central

    Edwards, Todd C.; Fredericksen, Rob J.; Crane, Heidi M.; Crane, Paul K.; Kitahata, Mari M.; Matthews, William C.; Mayer, Kenneth H.; Morales, Leo S.; Mugavero, Michael J.; Solorio, Rosa; Yang, Frances M.; Patrick, Donald L.

    2015-01-01

    Purpose To assess content validity and patient and provider prioritization of Patient Reported Outcomes Measurement Information System (PROMIS) Depression, Anxiety, Fatigue, and Alcohol Use items in the context of clinical care for people living with HIV (PLWH), and to develop and assess new items as needed. Methods We conducted concept elicitation interviews (n=161), item pool matching, prioritization focus groups (n=227 participants), and cognitive interviews (n=48) with English-speaking (~75%) and Spanish-speaking (~25%) PLWH from clinical sites in Seattle, San Diego, Birmingham, and Boston. For each domain we also conducted item review and prioritization with two HIV provider panels of 3 to 8 members each. Results Among items most highly prioritized by PLWH and providers were those that included information regarding personal impacts of the concept being assessed, in addition to severity level. Items that addressed impact were considered most actionable for clinical care. We developed additional items addressing this. For depression we developed items related to suicide and other forms of self-harm, and for all domains we developed items addressing impacts PLWH and/or providers indicated were particularly relevant to clinical care. Across the 4 domains, 16 new items were retained for further psychometric testing. Conclusion PLWH and providers had priorities for what they believed providers should know to provide optimal care for PLWH. Incorporation of these priorities into clinical assessments used in clinical care of PLWH may facilitate patient-centered care. PMID:26245710

  15. Development and psychometric evaluation of a new patient-reported outcome instrument measuring the functional impact of insomnia.

    PubMed

    Bell, Christopher; McLeod, Lori D; Nelson, Lauren M; Fehnel, Sheri E; Zografos, Laurie J; Bowers, Brian

    2011-11-01

    The objective of this study was to develop and validate a patient-reported outcome instrument to comprehensively assess the consequences of inadequate sleep for use in insomnia-related studies. To inform item development, relevant constructs were identified through patient focus groups, literature review, and expert input. Following a translatability assessment for United States (US) English, US Spanish, and French, the draft items were refined through iterative sets of patient interviews in the United States and France. Psychometric properties were evaluated using patient responses from a validation study including 432 participants with either a diagnosis of primary insomnia or no history of insomnia. Psychometric analyses supported item reduction from 38 to 26 items, yielding a unidimensional scale and preserving the original content (mood, tiredness/energy, memory/concentration, motivation, daily performance, social interaction, sexual functioning). Evidence of internal consistency (coefficient α = 0.97), convergent validity, and known-groups validity also was documented. The Sleep Functional Impact Scale (SFIS) is a psychometrically sound measure targeting the impact of insomnia on patient functioning. When administered with a sleep diary, this instrument has the ability to provide a more comprehensive assessment of treatment response in clinical studies.

  16. Development and validation of patient-reported outcome measures for sleep disturbance and sleep-related impairments.

    PubMed

    Buysse, Daniel J; Yu, Lan; Moul, Douglas E; Germain, Anne; Stover, Angela; Dodds, Nathan E; Johnston, Kelly L; Shablesky-Cade, Melissa A; Pilkonis, Paul A

    2010-06-01

    To develop an archive of self-report questions assessing sleep disturbance and sleep-related impairments (SRI), to develop item banks from this archive, and to validate and calibrate the item banks using classic validation techniques and item response theory analyses in a sample of clinical and community participants. Cross-sectional self-report study. Academic medical center and participant homes. One thousand nine hundred ninety-three adults recruited from an Internet polling sample and 259 adults recruited from medical, psychiatric, and sleep clinics. None. This study was part of PROMIS (Patient-Reported Outcomes Information System), a National Institutes of Health Roadmap initiative. Self-report item banks were developed through an iterative process of literature searches, collecting and sorting items, expert content review, qualitative patient research, and pilot testing. Internal consistency, convergent validity, and exploratory and confirmatory factor analysis were examined in the resulting item banks. Factor analyses identified 2 preliminary item banks, sleep disturbance and SRI. Item response theory analyses and expert content review narrowed the item banks to 27 and 16 items, respectively. Validity of the item banks was supported by moderate to high correlations with existing scales and by significant differences in sleep disturbance and SRI scores between participants with and without sleep disorders. The PROMIS sleep disturbance and SRI item banks have excellent measurement properties and may prove to be useful for assessing general aspects of sleep and SRI with various groups of patients and interventions.

  17. Evaluation of Gastrointestinal Patient Reported Outcomes Measurement Information System (GI-PROMIS) Symptom Scales in Subjects With Inflammatory Bowel Diseases.

    PubMed

    Kochar, Bharati; Martin, Christopher F; Kappelman, Michael D; Spiegel, Brennan M; Chen, Wenli; Sandler, Robert S; Long, Millie D

    2017-08-29

    Patient reported outcomes (PROs) are important treatment endpoints in inflammatory bowel diseases (IBD). We evaluated the gastrointestinal (GI) PRO Measurement Information System (PROMIS) in IBD subjects. Crohn's and Colitis Foundation of America's Partners is an Internet-based cohort of IBD subjects. Participants complete surveys, including demographics, disease characteristics, PROMIS domains, disease activity (short Crohn's disease activity index or simple clinical colitis activity index) and quality of life (QoL) indices. In a nested cross-sectional study, we used univariate and bivariate analyses to assess associations between 8 GI-PROMIS domains (reflux, swallowing, diarrhea, nausea, belly pain, gas, incontinence, and constipation) and QoL and disease activity indices. The study included 2,378 Crohn's Disease (CD) and 1,455 ulcerative colitis (UC) respondents with a median age of 41 years. Median disease duration was 11 years for CD subjects and 8 years for UC subjects; 57% of CD subjects and 42% of UC subjects were in remission. Among symptomatic CD subjects, those with active CD reported significantly worse symptoms on all 8 domains than those in remission. The same was observed for UC subjects with the exception of disrupted swallowing. IBD subjects with worse QoL reported significantly worse symptoms on all 8 domains compared to those with better QoL. In IBD subjects experiencing GI symptoms, GI-PROMIS domains were strongly associated with disease activity and QoL indices. GI-PROMIS holds potential as PRO measures in IBD and correlates with other validated indices in this population.Am J Gastroenterol advance online publication, 29 August 2017; doi:10.1038/ajg.2017.240.

  18. Integrating Patient-Reported Outcome Measures into Routine Cancer Care: Cancer Patients’ and Clinicians’ Perceptions of Acceptability and Value

    PubMed Central

    Stover, Angela; Irwin, Debra E.; Chen, Ronald C.; Chera, Bhishamjit S.; Mayer, Deborah K.; Muss, Hyman B.; Rosenstein, Donald L.; Shea, Thomas C.; Wood, William A.; Lyons, Jessica C.; Reeve, Bryce B.

    2015-01-01

    Introduction: Despite growing interest in integrating patient-reported outcome (PRO) measures of symptoms and functional status into routine cancer care, little attention has been paid to patients’ and clinicians’ perceptions of acceptability and value. Methods: A two-phase qualitative study was conducted to develop a web-based PRO screening system with 21 items assessing symptoms (e.g., nausea) and functional status. Phase 1 involved cognitive interviews with 35 cancer outpatients (n=9 breast chemotherapy, radiation for prostate (n=8) or head and neck cancer (n=10), and n=8 bone marrow transplant [BMT]). In Phase 2, we evaluated the acceptability and perceived value of reviewing a PRO measure during real-time clinical encounters with 39 additional outpatients (n=10 breast, n=9 head and neck, n=10 prostate, n=10 BMT) and 12 clinicians (n=3 breast, n=2 head and neck, n=4 prostate, n=3 BMT). At least 20% of patients were ≥60 years, African American, or ≤ high school. Results: Patients felt that their PRO summary of symptoms and functional status was helpful in discussing health issues with clinicians (92%), wanted to review their results with clinicians during future visits (82%), and would recommend it to other patients (87%). Clinicians found the PRO summary to be easy to interpret (83%), most helpful for documenting the Review of Symptoms (92%), and would recommend it to future patients (92%). Over 90% of clinicians reported that consultation time did not increase. Conclusion: Both cancer patients and clinicians reported that discussing a PRO summary of symptoms and functional status during an outpatient visit was useful, acceptable, and feasible. PMID:26557724

  19. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008.

    PubMed

    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

    2010-11-01

    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 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. Fourteen item pools were tested in the U.S. general population and clinical groups using an online panel and clinic recruitment. A scale-setting subsample was created reflecting demographics proportional to the 2000 U.S. census. 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 with the overall bank and with other well-validated and widely accepted ("legacy") measures. All item banks demonstrated good reliability across most of the score distributions. Construct validity was supported by moderate to strong correlations with legacy measures. PROMIS item banks and their short forms provide evidence that 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. Copyright © 2010 Elsevier Inc. All rights reserved.

  20. John Charnley Award: Preoperative Patient-reported Outcome Measures Predict Clinically Meaningful Improvement in Function After THA.

    PubMed

    Berliner, Jonathan L; Brodke, Dane J; Chan, Vanessa; SooHoo, Nelson F; Bozic, Kevin J

    2016-02-01

    Despite the overall effectiveness of total hip arthroplasty (THA), a subset of patients remain dissatisfied with their results because of persistent pain or functional limitations. It is therefore important to develop predictive tools capable of identifying patients at risk for poor outcomes before surgery. The purpose of this study was to use preoperative patient-reported outcome measure (PROM) scores to predict which patients undergoing THA are most likely to experience a clinically meaningful change in functional outcome 1 year after surgery. A retrospective cohort study design was used to evaluate preoperative and 1-year postoperative SF-12 version 2 (SF12v2) and Hip Disability and Osteoarthritis Outcome Score (HOOS) scores from 537 selected patients who underwent primary unilateral THA. Minimum clinically important differences (MCIDs) were calculated using a distribution-based method. A receiver operating characteristic analysis was used to calculate threshold values, defined as the levels at which substantial changes occurred, and their predictive ability. MCID values for HOOS and SF12v2 physical component summary (PCS) scores were calculated to be 9.1 and 4.6, respectively. We analyzed the effect of SF12v2 mental component summary (MCS) scores, which measure mental and emotional health, on SF12v2 PCS and HOOS threshold values. Threshold values for preoperative HOOS and PCS scores were a maximum of 51.0 (area under the curve [AUC], 0.74; p < 0.001) and 32.5 (AUC, 0.62; p < 0.001), respectively. As preoperative mental and emotional health improved, which was reflected by a higher MCS score, HOOS and PCS threshold values also increased. When preoperative mental and emotional health were taken into account, both HOOS and PCS threshold values' predictive ability improved (AUCs increased to 0.77 and 0.69, respectively). We identified PROM threshold values that predict clinically meaningful improvements in functional outcome after THA. Patients with a higher level

  1. 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

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

    PubMed

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

    2016-01-01

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

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

    PubMed

    Chen, Michael; Mangubat, Erwin; Ouyang, Bichun

    2016-01-01

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

  4. Responsiveness to Change and Minimally Important Differences of the Patient-Reported Outcomes Measurement Information System Gastrointestinal Symptoms Scales.

    PubMed

    Khanna, Dinesh; Hays, Ron D; Shreiner, Andrew B; Melmed, Gil Y; Chang, Lin; Khanna, Puja P; Bolus, Roger; Whitman, Cynthia; Paz, Sylvia H; Hays, Tonya; Reise, Steven P; Spiegel, Brennan

    2017-05-01

    The NIH-sponsored Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal (GI) Symptoms scales were developed to assess patients' GI symptoms in clinical settings. To assess responsiveness to change and provide minimally important difference (MID) estimates for the PROMIS GI Symptoms scales. A sample of 256 GI outpatients self-administered the eight PROMIS GI Symptoms scales (gastroesophageal reflux, disrupted swallowing, diarrhea, bowel incontinence/soilage, nausea and vomiting, constipation, belly pain, and gas/bloating/flatulence) at two visits. Patient self-reported and physician-reported assessments of the subjects' overall GI condition were employed as change anchors. In addition, we prospectively assessed change at both visits using a GI-symptom anchor, the Gastrointestinal Symptom Rating Scale (GSRS). Responsiveness to change was assessed using F-statistics. The minimally changed group was those somewhat better or somewhat worse on the retrospective anchors and changing by one category on the modified GSRS (e.g., from slight to mild discomfort to moderate to moderately severe discomfort). Responsiveness to change was statistically significant for 6 of 8 PROMIS scales using the self-report GI anchor, 3 of 8 scales using the physician-reported anchor, and 5 of 5 scales using the corresponding GSRS scales as anchors. The MID estimates for scales for improvement and worsening were about 0.5-0.6 SD using the GSRS anchor and generally larger in magnitude than the change for the "about the same" group. The responsiveness and MID estimates provided here for the PROMIS GI Symptoms scales can aid in scale score interpretation in clinical trials and observational studies.

  5. 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

  6. Engaging Patients as Partners in Developing Patient-Reported Outcome Measures in Cancer-A Review of the Literature.

    PubMed

    Camuso, Natasha; Bajaj, Prerna; Dudgeon, Deborah; Mitera, Gunita

    2016-08-01

    Tools to collect patient-reported outcome measures (PROMs) are frequently used in the healthcare setting to collect information that is most meaningful to patients. Due to discordance among how patients and healthcare providers rank symptoms that are considered most meaningful to the patient, engagement of patients in the development of PROMs is extremely important. This review aimed to identify studies that described how patients are involved in the item generation stage of cancer-specific PROM tools developed for cancer patients. A literature search was conducted using keywords relevant to PROMs, cancer, and patient engagement. A manual search of relevant reference lists was also conducted. Inclusion criteria stipulated that publications must describe patient engagement in the item generation stage of development of cancer-specific PROM tools. Results were excluded if they were duplicate findings or non-English. The initial search yielded 230 publications. After removal of duplicates and review of publications, 6 were deemed relevant. Fourteen additional publications were retrieved through a manual search of references from relevant publications. A total of 13 unique PROM tools that included patient input in item generation were identified. The most common method of patient engagement was through qualitative interviews or focus groups. Despite recommendations from international groups and the emphasized importance of incorporating patient feedback in all stages of development of PROMs, few unique tools have incorporated patient input in item generation of cancer-specific tools. Moving forward, a framework of best practices on how to best engage patients in developing PROMs is warranted to support high-quality patient-centered care.

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

    PubMed

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

    2012-06-26

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

  8. Psychometric properties of Patient Reported Outcome Measures (PROMs) in patients diagnosed with Acute Respiratory Distress Syndrome (ARDS).

    PubMed

    Shah, Hiral Anil; Dritsaki, Melina; Pink, Joshua; Petrou, Stavros

    2016-01-27

    The aim of this study was to assess the psychometric properties of the EQ-5D-3 L, the SF-12 v2 and its preference based derivative the SF-6D, and the St Georges Respiratory Questionnaire (SGRQ), in patients diagnosed with Acute Respiratory Distress Syndrome (ARDS). Data from the Oscillation in ARDS (OSCAR) randomised unblinded clinical trial of 795 patients diagnosed with ARDS provided the foundation of this secondary psychometric analysis. The three source patient reported outcome measures (PROMs) (EQ-5D-3 L, SF-12 and SGRQ) were collected at both 6 and 12 months post randomisation. All measures were tested for acceptability, reliability, internal consistency, validity and responsiveness. Data from responders at 6 months was used to test for acceptability, reliability, known groups validity and internal responsiveness. Data from patients who responded at both 6 and 12 months was used to test for convergent validity and external responsiveness. Rates of response at both 6 and 12 months post randomisation were 89.88 % for the EQ-5D-3 L, 77.38 % for the SF-6D, 71.43 % for both the physical and mental components of the SF-12 and 38.10 % for the SGRQ. All measures had a Cronbach's Alpha statistic higher than 0.7. For known group's validity, there was no difference in mean summary or utility scores between known groups for all PROMs with minimal effect sizes. All three source measures showed strong convergent and discriminant validity. There was consistent evidence that the SF-6D is an empirically valid and efficient alternative to the EQ-5D-3 L. The EQ-5D-3 L and SGRQ were more responsive compared to the SF-12 and SF-6D with the EQ-5D-3 L generating greater effect sizes than the SGRQ. The PROMs explored in this study displayed varying psychometric properties in the context of ARDS. Further research should focus on shortening the SGRQ whilst still maintaining its psychometric properties and mapping between the SGRQ and preference-based measures for future application

  9. 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

  10. Design and methodology of SNAP-1: a Sprint National Anaesthesia Project to measure patient reported outcome after anaesthesia.

    PubMed

    Moonesinghe, Suneetha Ramani; Walker, Eleanor Mary Kate; Bell, Madeline

    2015-01-01

    Patient satisfaction is an important metric of health-care quality. Accidental awareness under general anaesthesia (AAGA) is a serious complication of anaesthesia care which may go unrecognised in the immediate perioperative period but leads to long-term psychological harm for affected patients. The SNAP-1 study aimed to measure patient satisfaction with anaesthesia care and the incidence of AAGA, reported on direct questioning within 24 h of surgery, in a large multicentre cohort. A secondary aim of SNAP-1 was to test the effectiveness of a new network of Quality Audit and Research Coordinators in NHS anaesthetic departments, to achieve widespread study participation and high patient recruitment rates. This manuscript describes the study methodology. SNAP-1 was a prospective observational cohort study. The study protocol was approved by the National Research Ethics Service. All UK NHS hospitals with anaesthetic departments were invited to participate. Adult patients undergoing any type of non-obstetric surgery were recruited in participating hospitals on 13th and 14th May 2014. Demographic data were collected by anaesthetists providing perioperative care. Patients were then approached within 24 h of surgery to complete two questionnaires-the Bauer patient satisfaction questionnaire (to measure patient reported outcome) and the modified Brice questionnaire (to detect possible accidental awareness). Completion of postoperative questionnaires was taken as evidence of implied consent. Results were recorded on a standard patient case report form, and local investigators entered anonymised data into an electronic database for later analysis by the core research team. Preliminary analyses indicate that over 15,000 patients were recruited across the UK, making SNAP-1 the largest NIHR portfolio-adopted study in anaesthesia to date. Both descriptive and analytic epidemiological analyses will be used to answer specific questions about the patient perception of anaesthesia

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

    PubMed

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

    2014-06-26

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

  12. The Munich Knee Questionnaire: Development and Validation of a New Patient-Reported Outcome Measurement Tool for Knee Disorders.

    PubMed

    Beirer, Marc; Fiedler, Nico; Huber, Stephan; Schmitt-Sody, Marcus; Lorenz, Stephan; Biberthaler, Peter; Kirchhoff, Chlodwig

    2015-08-01

    To develop and validate an all-purpose patient-reported outcome questionnaire for a patient-based follow-up examination regarding knee disorders. Each scale of the Knee Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score, Lysholm knee score, Western Ontario Meniscal Evaluation Tool (WOMET) score, and Tegner score was analyzed, and after matching of the general topics, the dedicated items underwent a fusion to the final Munich Knee Questionnaire (MKQ) item and a score comprising 33 items was created. In a prospective clinical study, we evaluated validity, reliability, and responsiveness in 152 physical active patients (75 women and 77 men; mean age, 47 years) with traumatic as well as degenerative knee disorders. Test-retest reliability was substantial, with intraclass correlation coefficients of at least 0.91. Construct validity and responsiveness were confirmed by correlation coefficients of 0.78 to 0.86 (P = .01) and 0.41 to 0.71, respectively. Correlation coefficients of the original scores (KOOS, IKDC, Lysholm, WOMET, and Tegner) and the scores calculated from the MKQ were between 0.80 and 0.91 (P = .01). The MKQ is a reliable and valid patient-reported outcome questionnaire for assessing knee function. It seems to enable the calculation of the original items of the KOOS, IKDC score, Lysholm knee score, WOMET score, and Tegner score. The MKQ facilitates the comparison of treatment results in knee disorders and allows the evaluation of treatment efficacy. Identified inadequate treatment concepts could be eliminated, leading to increased patient satisfaction and optimized quality of health care. Copyright © 2015 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

  13. 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

  14. 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

  15. Can Preoperative Patient-reported Outcome Measures Be Used to Predict Meaningful Improvement in Function After TKA?

    PubMed

    Berliner, Jonathan L; Brodke, Dane J; Chan, Vanessa; SooHoo, Nelson F; Bozic, Kevin J

    2017-01-01

    Despite the overall effectiveness of total knee arthroplasty (TKA), a subset of patients do not experience expected improvements in pain, physical function, and quality of life as documented by patient-reported outcome measures (PROMs), which assess a patient's physical and emotional health and pain. It is therefore important to develop preoperative tools capable of identifying patients unlikely to improve by a clinically important margin after surgery. The purpose of this study was to determine if an association exists between preoperative PROM scores and patients' likelihood of experiencing a clinically meaningful change in function 1 year after TKA. A retrospective study design was used to evaluate preoperative and 1-year postoperative Knee injury and Osteoarthritis Outcome Score (KOOS) and SF-12 version 2 (SF12v2) scores from 562 patients who underwent primary unilateral TKA. This cohort represented 75% of the 750 patients who underwent surgery during that time period; a total of 188 others (25%) either did not complete PROM scores at the designated times or were lost to follow-up. Minimum clinically important differences (MCIDs) were calculated for each PROM using a distribution-based method and were used to define meaningful clinical improvement. MCID values for KOOS and SF12v2 physical component summary (PCS) scores were calculated to be 10 and 5, respectively. A receiver operating characteristic analysis was used to determine threshold values for preoperative KOOS and SF12v2 PCS scores and their respective predictive abilities. Threshold values defined the point after which the likelihood of clinically meaningful improvement began to diminish. Multivariate regression was used to control for the effect of preoperative mental and emotional health, patient attributes quantified by SF12v2 mental component summary (MCS) scores, on patients' likelihood of experiencing meaningful improvement in function after surgery. Threshold values for preoperative KOOS and SF

  16. Pulmonary symptoms measured by the national institutes of health lung score predict overall survival, nonrelapse mortality, and patient-reported outcomes in chronic graft-versus-host disease.

    PubMed

    Palmer, Jeanne; Williams, Kirsten; Inamoto, Yoshihiro; Chai, Xiaoyu; Martin, Paul J; Tomas, Linus Santo; Cutler, Corey; Weisdorf, Daniel; Kurland, Brenda F; Carpenter, Paul A; Pidala, Joseph; Pavletic, Steven Z; Wood, William; Jacobsohn, David; Arai, Sally; Arora, Mukta; Jagasia, Madan; Vogelsang, Georgia B; Lee, Stephanie J

    2014-03-01

    The 2005 National Institutes of Health (NIH) Consensus Conference recommended assessment of lung function in patients with chronic graft-versus-host disease (GVHD) by both pulmonary function tests (PFTs) and assessment of pulmonary symptoms. We tested whether pulmonary measures were associated with nonrelapse mortality (NRM), overall survival (OS), and patient-reported outcomes (PRO). Clinician and patient-reported data were collected serially in a prospective, multicenter, observational study. Available PFT data were abstracted. Cox regression models were fit for outcomes using a time-varying covariate model for lung function measures and adjusting for patient and transplantation characteristics and nonlung chronic GVHD severity. A total of 1591 visits (496 patients) were used in this analysis. The NIH symptom-based lung score was associated with NRM (P = .02), OS (P = .02), patient-reported symptoms (P < .001) and functional status (P < .001). Worsening of NIH symptom-based lung score over time was associated with higher NRM and lower survival. All other measures were not associated with OS or NRM; although, some were associated with patient-reported lung symptoms. In conclusion, the NIH symptom-based lung symptom score of 0 to 3 is associated with NRM, OS, and PRO measures in patients with chronic GVHD. Worsening of the NIH symptom-based lung score was associated with increased mortality.

  17. Assessment of Disability Related to Femoroacetabular Impingement Syndrome by Use of the Patient-Reported Outcome Measure Information System (PROMIS) and Objective Measures of Physical Performance.

    PubMed

    Sheean, Andrew J; Schmitz, Matthew R; Ward, Catherine L; Barrow, Aaron E; Tennent, David J; Roach, Christopher J; Burns, Travis C; Wilken, Jason M

    2017-09-01

    The National Institutes of Health (NIH)-sponsored Patient-Reported Outcomes Measurement System (PROMIS) has been described as a valuable tool for characterizing outcomes among patients with specific musculoskeletal conditions. Additionally, previously proposed objective measures of physical performance among patients with nonarthritic hip abnormalities are costly and not practically incorporated into routine clinical practice. (1) To determine the ability of the PROMIS to differentiate between patients with femoroacetabular impingement (FAI) and asymptomatic controls, (2) to determine the effect of FAI on subjects' completion of timed physical performance measures, and (3) to determine whether associations exist between established patient-reported outcome (PRO) measures and subjects' completion of physical performance measures. Cross-sectional study; Level of evidence, 3. Twenty-two asymptomatic controls (CON group) and 20 patients with FAI completed multiple activities to assess physical ability: self-selected walking velocity (SSWV), timed stair ascent (TSA), four-square step test (FSST), and sit-to-stand five times test (STS5). All subjects also underwent a battery of PRO questionnaires: Visual Analog Scale for Pain (VAS), Modified Harris Hip Score (mHHS), International Hip Outcome Tool (iHOT-33), Hip Disability and Osteoarthritis Outcome Score (HOOS), and PROMIS. Descriptive analyses were performed and comparisons between groups were made by use of paired t tests with Bonferroni-Holm correction. Spearman's rank correlation coefficients were used to determine associations between physical performance measures and PRO. The magnitude of differences between groups for each measured variable was calculated by use of Cohen's d. Significant differences between CON and FAI groups were observed for all hip-specific PRO measures (CON vs FAI for all; HOOS 99.2 vs 42.8, P < .001, iHOT-33 99.0 vs 26.6, P < .001, mHHS 99.6 vs 62.2, P < .001). Similarly, PROMIS scores were

  18. Patient reported outcomes in benign multiple sclerosis.

    PubMed

    Hviid, Line E; Healy, Brian C; Rintell, David J; Chitnis, Tanuja; Weiner, Howard L; Glanz, Bonnie I

    2011-07-01

    Benign MS patients have a mild course of disease and show no or minimal accumulation of disability over time. Little is known about the patient reported outcomes (PROs) in benign MS. The objective of the study was to compare PROs in benign MS patients and patients with similar disease duration or disability status, and to investigate how the definition of benign MS affected this outcome. Two groups of Benign MS patients (disease duration ≥15 years, Expanded Disability Status Scale [EDSS] score ≤1.5 [Benign-1.5], or ≤3.0 [Benign-3]) were compared with four other MS groups: disease duration ≥15 years, EDSS score >3.0 (Late-MS); disease duration <15 years, and EDSS score ≤1.5 (Low-EDSS-1.5), or ≤3.0 (Low-EDSS-3); disease duration ≤5 years (Early-MS). PROs included measures of QOL, fatigue, depression, and social support. Cognitive function was also assessed. Both benign groups had better PROs than Late MS patients on all measures (p < 0.05). QOL, depression, and fatigue were significantly different between Benign-1.5 and Early-MS groups (p < 0.01). Benign-1.5 had higher mental health QOL than Low EDSS-1.5, but was otherwise similar. Benign-3 patients had worse depression than Early-MS (p < 0.01), and worse cognition compared with Low-EDSS-3 (p = 0.033). Benign-1.5 had higher QOL and lower fatigue (p < 0.005) than Benign-2-3, and showed a marginally significant difference in cognitive functioning (p = 0.055). Patients with benign MS had better PROs than other groups of MS patients, suggesting that both disease duration and disability influence PROs. The study also showed a difference in PROs based on the way benign MS was defined.

  19. Systematic review of systemic sclerosis-specific instruments for the EULAR Outcome Measures Library: An evolutional database model of validated patient-reported outcomes.

    PubMed

    Ingegnoli, Francesca; Carmona, Loreto; Castrejon, Isabel

    2017-04-01

    The EULAR Outcome Measures Library (OML) is a freely available database of validated patient-reported outcomes (PROs). The aim of this study was to provide a comprehensive review of validated PROs specifically developed for systemic sclerosis (SSc) to feed the EULAR OML. A sensitive search was developed in Medline and Embase to identify all validation studies, cohort studies, reviews, or meta-analyses in which the objective were the development or validation of specific PROs evaluating organ involvement, disease activity or damage in SSc. A reviewer screened title and abstracts, selected the studies, and collected data concerning validation using ad hoc forms based on the COSMIN checklist. From 13,140 articles captured, 74 met the predefined criteria. After excluding two instruments as they were unavailable in English the selected 23 studies provided information on seven SSc-specific PROs on different SSc domains: burden of illness (symptom burden index), functional status (Scleroderma Assessment Questionnaire), functional ability (scleroderma Functional Score), Raynaud's phenomenon (Raynaud's condition score), mouth involvement (Mouth Handicap in SSc), gastro-intestinal involvement (University of California Los Angeles-Scleroderma Clinical Trial Consortium Gastro-Intestinal tract 2.0), and skin involvement (skin self-assessment). Each of them is partially validated and has different psychometric requirements. Seven SSc-specific PROs have a minimum validation and were included in the EULAR OML. Further development in the area of disease-specific PROs in SSc is warranted. Copyright © 2017 Elsevier Inc. All rights reserved.

  20. Physical function metric over measure: An illustration with the Patient-Reported Outcomes Measurement Information System (PROMIS) and the Functional Assessment of Cancer Therapy (FACT).

    PubMed

    Kaat, Aaron J; Schalet, Benjamin D; Rutsohn, Joshua; Jensen, Roxanne E; Cella, David

    2017-09-08

    Measuring patient-reported outcomes (PROs) is becoming an integral component of quality improvement initiatives, clinical care, and research studies in cancer, including comparative effectiveness research. However, the number of PROs limits comparability across studies. Herein, the authors attempted to link the Functional Assessment of Cancer Therapy-General Physical Well-Being (FACT-G PWB) subscale with the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) calibrated item bank. The also sought to augment a subset of the conceptually most similar FACT-G PWB items with PROMIS PF items to improve the linking. Baseline data from 5506 participants in the Measuring Your Health (MY-Health) study were used to identify the optimal items for linking FACT-G PWB with PROMIS PF. A mixed methods approach identified the optimal items for creating the 5-item FACT/PROMIS-PF5 scale. Both the linked and augmented relationships were cross-validated using the follow-up MY-Health data. A 5-item FACT-G PWB item subset was found to be optimal for linking with PROMIS PF. In addition, a 2-item subset, including only items that were conceptually very similar to the PROMIS item bank content, were augmented with 3 PROMIS PF items. This new FACT/PROMIS-PF5 provided superior score recovery. The PROMIS PF metric allows for the evaluation of the extent to which similar questionnaires can be linked and therefore expressed on the same metric. These results allow for the aggregation of existing data and provide an optimal measure for future studies wishing to use the FACT yet also report on the PROMIS PF metric. Cancer 2017. © 2017 American Cancer Society. © 2017 American Cancer Society.

  1. Feedback on the FDA's February 2006 draft guidance on Patient Reported Outcome (PRO) measures from a developer of PRO measures.

    PubMed

    Bradley, Clare

    2006-10-09

    I believe that the FDA guidelines have already had an impact in encouraging good practice in the use of PROs. There are, however, important improvements that need to be made to the guidelines, particularly in the use of health status and quality of life terminology. It is essential to distinguish between health status and quality of life and to use both terms. Nothing is to be gained and a great deal will be lost if the term quality of life (which has been misused as an umbrella term in the past) is abandoned and replaced with the term health status. Patients want us to consider their quality of life as well as their health. To abandon the term would be to forget about their quality of life and focus only on their health. Patients are well able to tell us what quality of life means to them and to rate the impact of a condition on their quality of life if we use individualised quality of life measures and individualised condition-specific quality of life measures to allow them to do so. Although my experience with PRO measures would support many of the recommendations in the guidelines there are others that I would not fully agree with or would contradict on the basis of my own research evidence. I have provided references to that research and hope that the FDA will feel able to do the same when they finalize their guidelines.

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

    PubMed

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

    2015-01-01

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

  3. The development of a patient-reported outcome measure for assessing nighttime symptoms of chronic obstructive pulmonary disease

    PubMed Central

    2013-01-01

    Background The assessment of symptoms of chronic obstructive pulmonary disease (COPD) is important for monitoring and managing the disease and for evaluating outcomes of interventions. COPD patients experience symptoms during the day and night, and symptoms experienced at night often disturb sleep. The aim of this paper is to describe methods used to develop a patient-reported outcome (PRO) instrument for evaluating nighttime symptoms of COPD, and to document evidence for the content validity of the instrument. Methods Literature review and clinician interviews were conducted to inform discussion guides to explore patients’ nighttime COPD symptom experience. Data from focus groups with COPD patients was used to develop a conceptual framework and the content of a new PRO instrument. Patient understanding of the new instrument was assessed via cognitive interviews with COPD patients. Results The literature review confirmed that there is no instrument with evidence of content validity currently available to assess nighttime symptoms of COPD. Additionally, the literature review and clinician interviews suggested the need to understand patients’ experience of specific symptoms in order to evaluate nighttime symptoms of COPD. Analyses of patient focus group data (N = 27) supported saturation of concepts and aided in development of a conceptual framework. Items were generated using patients’ terminology to collect data on concepts in the framework including the occurrence and severity of COPD symptoms, use of rescue medication at night, and nocturnal awakening. Response options were chosen to reflect concepts that were salient to patients. Subsequent cognitive interviewing with ten COPD patients demonstrated that the items, response options, recall period, and instructions were understandable, relevant, and interpreted as intended. Conclusions A new PRO instrument, the Nighttime Symptoms of COPD Instrument (NiSCI), was developed with documented evidence of content

  4. The relationship between spinopelvic measurements and patient-reported outcome scores in patients with multiple myeloma of the spine.

    PubMed

    Yu, H M; Malhotra, K; Butler, J S; Patel, A; Sewell, M D; Li, Y Z; Molloy, S

    2016-09-01

    Patients with multiple myeloma (MM) develop deposits in the spine which may lead to vertebral compression fractures (VCFs). Our aim was to establish which spinopelvic parameters are associated with the greatest disability in patients with spinal myeloma and VCFs. We performed a retrospective cross-sectional review of 148 consecutive patients (87 male, 61 female) with spinal myeloma and analysed correlations between spinopelvic parameters and patient-reported outcome scores. The mean age of the patients was 65.5 years (37 to 91) and the mean number of vertebrae involved was 3.7 (1 to 15). The thoracolumbar region was most commonly affected (109 patients, 73.6%), and was the site of most posterior vertebral wall defects (47 patients, 31.8%). Poorer Oswestry Disability Index scores correlated with an increased sagittal vertical axis (p = 0.006), an increased number of VCFs (p = 0.035) and sternal involvement (p = 0.012). Poorer EuroQol visual analogue scale scores correlated with posterior vertebral wall defects in the thoracolumbar region (p = 0.012). The sagittal vertical axis increased with the number of fractures and kyphosis in the thoracolumbar (p = 0.009) and lumbar (p < 0.001) regions. In MM, patients with VCFs have poorer clinical scores at presentation in the presence of sagittal imbalance. Outcome is particularly affected by multiple fractures in the thoracolumbar and lumbar regions and by failure to prevent kyphosis. Patients with MM should be screened for spinal lesions early. Cite this article: Bone Joint J 2016;98-B:1234-9. ©2016 The British Editorial Society of Bone & Joint Surgery.

  5. The development of a patient-reported outcome measure for assessing nighttime symptoms of chronic obstructive pulmonary disease.

    PubMed

    Hareendran, Asha; Palsgrove, Andrew C; Mocarski, Michelle; Schaefer, Michael L; Setyawan, Juliana; Carson, Robyn; Make, Barry

    2013-06-25

    The assessment of symptoms of chronic obstructive pulmonary disease (COPD) is important for monitoring and managing the disease and for evaluating outcomes of interventions. COPD patients experience symptoms during the day and night, and symptoms experienced at night often disturb sleep. The aim of this paper is to describe methods used to develop a patient-reported outcome (PRO) instrument for evaluating nighttime symptoms of COPD, and to document evidence for the content validity of the instrument. Literature review and clinician interviews were conducted to inform discussion guides to explore patients' nighttime COPD symptom experience. Data from focus groups with COPD patients was used to develop a conceptual framework and the content of a new PRO instrument. Patient understanding of the new instrument was assessed via cognitive interviews with COPD patients. The literature review confirmed that there is no instrument with evidence of content validity currently available to assess nighttime symptoms of COPD. Additionally, the literature review and clinician interviews suggested the need to understand patients' experience of specific symptoms in order to evaluate nighttime symptoms of COPD. Analyses of patient focus group data (N = 27) supported saturation of concepts and aided in development of a conceptual framework. Items were generated using patients' terminology to collect data on concepts in the framework including the occurrence and severity of COPD symptoms, use of rescue medication at night, and nocturnal awakening. Response options were chosen to reflect concepts that were salient to patients. Subsequent cognitive interviewing with ten COPD patients demonstrated that the items, response options, recall period, and instructions were understandable, relevant, and interpreted as intended. A new PRO instrument, the Nighttime Symptoms of COPD Instrument (NiSCI), was developed with documented evidence of content validity. The NiSCI is ready for empirical

  6. Comparability of the Patient-Reported Outcomes Measurement Information System Pediatric short form symptom measures across culture: examination between Chinese and American children with cancer.

    PubMed

    Liu, Yanyan; Yuan, Changrong; Wang, Jichuan; Brown, Jeanne Geiger; Zhou, Fen; Zhao, Xiufang; Shen, Min; Hinds, Pamela S

    2016-10-01

    Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric forms measure symptoms and function of pediatric patients experiencing chronic disease by using the same measures. Comparability is one of the most important purposes of the PROMIS initiative. This study aimed to test the factorial structures of four symptom measures (i.e., Anxiety, Depression, Fatigue, and Pain Interference) in the original English and the Chinese versions and examine the measurement invariance of the measures across two cultures. Four PROMIS Pediatric measures were used to assess symptoms, respectively, in Chinese (n = 232) and American (n = 200) children and adolescents (8-17 years old) in treatment for cancer or in survivorship. The categorical confirmatory factor analysis (CCFA) model was used to examine factorial structures, and multigroup CCFA was applied to test measurement invariance of these measures between the Chinese and American samples. The CCFA models of the four PROMIS Pediatric symptom measures fit the data well for both the Chinese and American children and adolescents. Minor partial measurement invariance was identified. Factor means and factor variances of the four PROMIS measures were not significantly different between the two populations. Our results provide evidence that the four PROMIS Pediatric symptom measures have valid factorial structures and a statistical property of measurement invariance across American and Chinese children and adolescents with cancer. This means that the items of these measures were interpreted in a conceptually similar manner by two groups. They could be readily used for meaningful cross-cultural comparisons involving pediatric oncology patients in these two countries.

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

    PubMed

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

    2015-01-01

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

  8. Transperineal prostate biopsies for diagnosis of prostate cancer are well tolerated: a prospective study using patient-reported outcome measures

    PubMed Central

    Wadhwa, Karan; Carmona-Echeveria, Lina; Kuru, Timur; Gaziev, Gabriele; Serrao, Eva; Parashar, Deepak; Frey, Julia; Dimov, Ivailo; Seidenader, Jonas; Acher, Pete; Muir, Gordon; Doble, Andrew; Gnanapragasam, Vincent; Hadaschik, Boris; Kastner, Christof

    2017-01-01

    We aimed to determine short-term patient-reported outcomes in men having general anesthetic transperineal (TP) prostate biopsies. A prospective cohort study was performed in men having a diagnostic TP biopsy. This was done using a validated and adapted questionnaire immediately post-biopsy and at follow-up of between 7 and 14 days across three tertiary referral hospitals with a response rate of 51.6%. Immediately after biopsy 43/201 (21.4%) of men felt light-headed, syncopal, or suffered syncope. Fifty-three percent of men felt discomfort after biopsy (with 95% scoring <5 in a 0–10 scale). Twelve out of 196 men (6.1%) felt pain immediately after the procedure. Despite a high incidence of symptoms (e.g., up to 75% had some hematuria, 47% suffered some pain), it was not a moderate or serious problem for most, apart from hemoejaculate which 31 men suffered. Eleven men needed catheterization (5.5%). There were no inpatient admissions due to complications (hematuria, sepsis). On repeat questioning at a later time point, only 25/199 (12.6%) of men said repeat biopsy would be a significant problem despite a significant and marked reduction in erectile function after the procedure. From this study, we conclude that TP biopsy is well tolerated with similar side effect profiles and attitudes of men to repeat biopsy to men having TRUS biopsies. These data allow informed counseling of men prior to TP biopsy and a benchmark for tolerability with local anesthetic TP biopsies being developed for clinical use. PMID:26924279

  9. Quality of life of pediatric oncology patients: Do patient-reported outcome instruments measure what matters to patients?

    PubMed

    Anthony, Samantha J; Selkirk, Enid; Sung, Lillian; Klaassen, Robert J; Dix, David; Klassen, Anne F

    2017-02-01

    The assessment of quality of life (QOL) is key within pediatric oncology and requires a clearly defined construct of QOL. The purpose of our study was: (1) to conduct a qualitative study to inform the theoretical underpinnings of QOL and (2) to determine the appropriateness of patient-reported outcome (PRO) instruments to assess and evaluate QOL in pediatric cancer patients and survivors. The study used an interpretative description approach. Children diagnosed with childhood cancer, aged 8-18 years, were recruited from four Canadian hospitals. Semi-structured interviews were completed, transcribed verbatim and coded through methods of constant comparison. In-depth analysis facilitated a comparison between emerging themes and the content of commonly used PRO instruments. Thirty-seven children (19 females; 51 %) participated. The mean age was 13 years, and 19 (51 %) participants were post-treatment. Participant experiences reflected notions of positive and negative duality, including: maintaining physical functioning but longing for the ability to participate in activities; experiencing a new level of intimacy with family and friends amidst isolation; and developing positivity amidst anger, sadness and lingering worry. Analysis showed that existing PRO instruments are missing concerns specific to this population and contain content not reflective of the QOL experiences of childhood cancer patients and survivors. Our research highlights important problems with content validity of existing PRO scales, indicating that the tools we have to date have limited utility in research and clinical practice. The development of a new PRO instrument should be considered to ensure that content validity is achieved.

  10. Overview of Classical Test Theory and Item Response Theory for Quantitative Assessment of Items in Developing Patient-Reported Outcome Measures

    PubMed Central

    Cappelleri, Joseph C.; Lundy, J. Jason; Hays, Ron D.

    2014-01-01

    Introduction The U.S. Food and Drug Administration’s patient-reported outcome (PRO) guidance document defines content validity as “the extent to which the instrument measures the concept of interest” (FDA, 2009, p. 12). “Construct validity is now generally viewed as a unifying form of validity for psychological measurements, subsuming both content and criterion validity” (Strauss & Smith, 2009, p. 7). Hence both qualitative and quantitative information are essential in evaluating the validity of measures. Methods We review classical test theory and item response theory approaches to evaluating PRO measures including frequency of responses to each category of the items in a multi-item scale, the distribution of scale scores, floor and ceiling effects, the relationship between item response options and the total score, and the extent to which hypothesized “difficulty” (severity) order of items is represented by observed responses. Conclusion Classical test theory and item response theory can be useful in providing a quantitative assessment of items and scales during the content validity phase of patient-reported outcome measures. Depending on the particular type of measure and the specific circumstances, either one or both approaches should be considered to help maximize the content validity of PRO measures. PMID:24811753

  11. Patient-reported outcomes in gastroenterology: clinical and research applications.

    PubMed

    Spiegel, Brennan M R

    2013-04-01

    Patient-generated reports, also known as Patient-Reported Outcomes (PROs), capture the patients' illness experience in a structured format and may help bridge the gap between patients and providers. PROs measure any aspect of patient-reported health (e.g., physical, emotional or social symptoms) and can help to direct care and improve clinical outcomes. When clinicians systematically collect patient-reported data in the right place at the right time, PRO measurement can effectively aid in detection and management of conditions, improve satisfaction with care and enhance the patient-provider relationship. This review article summarizes the latest approaches to PRO measuring for clinical trials and clinical practice, with a focus on use of PROs in gastroenterology.

  12. Translation and linguistic validation of the Pediatric Patient-Reported Outcomes Measurement Information System measures into simplified Chinese using cognitive interviewing methodology.

    PubMed

    Liu, Yanyan; Hinds, Pamela S; Wang, Jichuan; Correia, Helena; Du, Shizheng; Ding, Jian; Gao, Wen Jun; Yuan, Changrong

    2013-01-01

    The Pediatric Patient-Reported Outcomes Measurement Information System (PROMIS) measures were developed using modern measurement theory and tested in a variety of settings to assess the quality of life, function, and symptoms of children and adolescents experiencing a chronic illness and its treatment. Developed in English, this set of measures had not been translated into Chinese. The objective of this study was to develop the Chinese version of the Pediatric PROMIS measures (C-Ped-PROMIS), specifically 8 short forms, and to pretest the translated measures in children and adolescents through cognitive interviewing methodology. The C-Ped-PROMIS was developed following the standard Functional Assessment of Chronic Illness Therapy Translation Methodology. Bilingual teams from the United States and China reviewed the translation to develop a provisional version, which was then pretested with cognitive interview by probing 10 native Chinese-speaking children aged 8 to 17 years in China. The translation was finalized by the bilingual teams. Most items, response options, and instructions were well understood by the children, and some revisions were made to address patient's comments during the cognitive interview. The results indicated that the C-Ped-PROMIS items were semantically and conceptually equivalent to the original. Children aged 8 to 17 years in China were able to comprehend these measures and express their experience and feelings about illness or their life. The C-Ped-PROMIS is available for psychometric validation. Future work will be directed at translating the rest of the item banks, calibrating them and creating a Chinese final version of the short forms.

  13. Cross-cultural adaptation to Portuguese of a measure of satisfaction with participation of the Patient-Reported Outcomes Measurement Information System (PROMIS(r)).

    PubMed

    Silva, Maria Cristina Lima E; Mendonça, Tânia Maria da Silva; da Silva, Carlos Henrique Martins; Pinto, Rogério de Melo Costa

    2015-01-01

    Mental disorders often impair functioning in several areas of life and lead to unhappiness and suffering that may affect health-related quality of life (HRQoL). Satisfaction with participation is an indicator of HRQoL, and its measurement by patients reflects the impact of disease on their social, emotional and professional life. The Patient-Reported Outcomes Measurement Information System (PROMIS(r)) offers an item bank based on item response theory. This system provides efficient, reliable and valid self-report instruments of satisfaction with participation, a measure that is both scarce and useful in the assessment of mental disorder outcomes. To cross-culturally adapt the PROMIS(r) satisfaction with participation item bank to Portuguese. Cross-cultural adaptation followed the Functional Assessment of Chronic Illness Therapy (FACIT) multilingual translation method and was achieved through steps of forward and backward translations, review by bilingual experts (one of them a native of Portugal) and pretesting in a group of 11 adult native Brazilians. Instrument adaptation followed a universal approach to translation, with harmonization across languages. Equivalence of meaning was achieved. As two of the 26 translated items, which asked about leisure and social activities, were not understood by less educated participants, an explanation in parentheses was added to each item, and the problem was solved. All items were appropriate and did not cause embarrassment to the participants. The satisfaction with participation item bank is culturally and linguistically suitable to be used in Brazil. After the pretest is applied in Portugal and in other Portuguese-speaking countries, the same instrument will be ready to be used in multinational studies.

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

    PubMed Central

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

    2016-01-01

    Introduction Chronic kidney disease (CKD) is associated with symptoms that can significantly reduce the quality of life (QoL) of patients. Patient-reported outcome measures (PROMs) may facilitate the assessment of the impact of disease and treatment on the QoL, from a patient perspective. PROMs can be used in research and routine clinical practice. Methods and analysis A systematic review of studies evaluating the measurement properties of PROMs in adults with CKD will be conducted. MEDLINE, EMBASE, PsycINFO and CINAHL Plus will be systematically searched from inception. Hand searching of reference lists and citations of included studies will be carried out. 2 reviewers will independently screen the titles and abstracts of all the studies retrieved during the systematic search to determine their eligibility. The COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) checklist will be used to appraise the methodological quality of the selected studies following the full-text review. Data on the study population, questionnaire characteristics and measurement properties will be extracted from the selected papers. Finally, a narrative synthesis of extracted data will be undertaken. Ethics and dissemination Ethical permissions are not required for this study as data from published research articles will be used. Findings will be disseminated through publication in a peer-reviewed journal and presented at conferences. This systematic review will provide a comprehensive assessment of the measurement properties of PROMs currently available for use in adult patients with CKD and present evidence which may inform the selection of measures for use in research and clinical practice. Trial registration number CRD42016035554. PMID:27733411

  15. 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

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

    PubMed

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

    2017-08-01

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

  17. 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

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

    PubMed Central

    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.

    2015-01-01

    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

  19. Systematic review of cross-cultural adaptations of hip-specific patient-reported outcome measures in Spanish.

    PubMed

    Gómez-Valero, Sara; García-Pérez, Fernando; Flórez-García, Mariano Tomás; Miangolarra-Page, Juan Carlos

    2017-03-16

    The aim of this study was to conduct a systematic review of the quality of the transcultural adaptation procedure and the clinimetric properties of the self-administered hip-disability functional assessment questionnaires adapted for the Spanish population. We searched the MEDLINE, EMBASE, CINAHL and Web of Science databases (from inception until June 2016) to locate all the scales adapted to Spanish and to analyze the different phases of the adaptation process and its psychometric properties. Eight scales were identified, and were grouped into three sections, according to the type of diseases in which they can be used: a) lower limb: Lower Limb Functional Index (LLFI), Lower Extremity Functional Scale (LEFS) and Arthrosis of Membres Inférieurs et Qualité de vie (AMICAL); b) knee and/or hip: Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index, Osteoarthritis Knee and Hip Quality of Life (OAKHQOL) and Hip and Knee Questionnaire (HKQ); and c) specific for hip: Hip Outcome Score (HOS) and International Hip Outcome Tool-33 (iHOT-33). The transcultural adaptation procedure was satisfactory in all cases, albeit somewhat less rigorous for the HKQ and LLFI than for the remaining questionnaires. No study evaluated all the psychometric properties. We currently have 8 hip-disability functional assessment questionnaires adapted to Spanish with satisfactory psychometric properties. We can measure the patient's perceived impact of his or her hip disease by selecting, among the different options, those alternatives that best fit our clinical or research objectives. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.

  20. 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

  1. Sexual Functioning Along the Cancer Continuum: Focus Group Results from the Patient-Reported Outcomes Measurement Information System (PROMIS™)

    PubMed Central

    Flynn, Kathryn E.; Jeffery, Diana D.; Keefe, Francis J.; Porter, Laura S.; Shelby, Rebecca A.; Fawzy, Maria R.; Gosselin, Tracy K.; Reeve, Bryce B.; Weinfurt, Kevin P.

    2010-01-01

    Objective Cancer and treatments for cancer affect specific aspects of sexual functioning and intimacy; however, limited qualitative work has been done in diverse cancer populations. As part of an effort to improve measurement of self-reported sexual functioning, we explored the scope and importance of sexual functioning and intimacy to patients across cancer sites and along the continuum of care. Methods We conducted 16 diagnosis- and sex-specific focus groups with patients recruited from the Duke University tumor registry and oncology/hematology clinics (N=109). A trained note taker produced field notes summarizing the discussions. An independent auditor verified field notes against written transcripts. The content of the discussions was analyzed for major themes by two independent coders. Results Across all cancers, the most commonly discussed cancer- or treatment-related effects on sexual functioning and intimacy were fatigue, treatment-related hair loss, weight gain, and organ loss or scarring. Additional barriers were unique to particular diagnoses, such as shortness of breath in lung cancer, gastrointestinal problems in colorectal cancers, and incontinence in prostate cancer. Sexual functioning and intimacy were considered important to quality of life. While most effects of cancer were considered negative, many participants identified improvements to intimacy after cancer. Conclusion Overall evaluations of satisfaction with sex life did not always correspond to specific aspects of functioning (e.g. erectile dysfunction), presenting a challenge to researchers aiming to measure sexual functioning as an outcome. Health care providers should not assume that level of sexual impairment determines sexual satisfaction and should explore cancer patients’ sexual concerns directly. PMID:20878833

  2. 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

  3. 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.

  4. Patient Reported Outcomes from Sacroiliac Joint Fusion

    PubMed Central

    McGowan, Shane M.; Audley, Brittany N.; Sokunbi, Gbolabo; Puccio, Steven T.

    2017-01-01

    Study Design Retrospective, case series. Purpose The purpose of this study is to determine morbidity, complications, and patient reported outcomes from minimally invasive sacroiliac joint (SIJ) fusion. Overview of Literature Lumbar back pain emanating from the SIJ can be surgically treated via a percutaneous approach in the appropriately selected patient with minimal morbidity and acceptable functional outcomes. Methods Patients diagnosed by >2 physical examination maneuvers and subjective relief from a computed tomography–guided lidocaine-bupivacaine-steroid injection underwent SIJ fusion after failing conservative management with a combination of oral anti-inflammatory medications, physical therapy, and pelvic belt stabilization. Perioperative data collected include estimated blood loss (EBL) and operative time. Oswestry disability index, 12-item short form health survey (SF-12), visual analogue score, and functional status were analyzed. All complications were noted. Results The study cohort of 45 cases (69% female) achieved postoperative survey follow-up at 9.9 and 32.3 months. SF-12 physical component summary statistically improved while all other scores were equivalent. Mean EBL and operative time were 22 mL and 36 minutes, respectively. Initial survey showed that 64% of patients discontinued narcotics (29/45), 71% do not use an assistive device (32/45), and 15.6% do not work due to pain (7/45). 73% of patients stated they would have the surgery again (33/45). For the second survey, 65% of patients discontinued narcotics (26/40), 70% did not use an assistive device (28/40), and 17.5% did not work due to pain (7/40). A history of thoracolumbar instrumentation (16/45) did not significantly affect outcomes. Three complications described by screw malposition with neurologic deficit (6.7%) were treated with screw repositioning (1 case) and removal of a single superior implant (2 cases) with time to revision of 2.2 months. All three ultimately had resolution of

  5. 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

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

    PubMed

    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.

  7. Performance of the Patient-Reported Outcomes Measurement Information System 29-Item Profile in Rheumatoid Arthritis, Osteoarthritis, Fibromyalgia, and Systemic Lupus Erythematosus.

    PubMed

    Katz, Patricia; Pedro, Sofia; Michaud, Kaleb

    2017-09-01

    The Patient-Reported Outcomes Measurement Information System (PROMIS) was developed to improve measurement of patient-reported outcomes. We examined performance of the 29-item PROMIS Profile (PROMIS-29) in persons with rheumatoid arthritis (RA), osteoarthritis (OA), fibromyalgia (FM), and systemic lupus erythematosus (SLE). Participants in the National Data Bank for Rheumatic Diseases completed the PROMIS-29, which includes 4-item forms for 7 PROMIS domains. Scales were scored and converted to T scores. Distributions of scale scores were examined, convergent and known-groups validity was tested, and differences in scores from online versus paper questionnaires were examined. Sample sizes were 4,346 for RA, 727 for OA, 241 for FM, and 240 for SLE. Participants were predominantly female, with a mean disease duration ≥20 years, and were ages ∼60 years. Large ceiling effects occurred for some PROMIS-29 scales. Correlations of PROMIS-29 scores with scales measuring similar constructs ranged from high to moderate for RA, OA, and SLE; correlations for FM were markedly lower for some scales. Consistent patterns of worsening PROMIS-29 scores with increasing disease severity or declining health status were observed. Differences in scores obtained by online versus paper questionnaires ranged from 0.3 to 2.2 points. Results provide guarded support for using the PROMIS-29 in these conditions. The PROMIS-29 4-item static forms appear to identify differences among levels of health and to measure constructs similar to those measured by legacy questionnaires. However, large ceiling effects suggest that measurement may be more precise at the "bad" ends of the scales, which may limit responsiveness, and differences by mode of administration appear to exist. © 2016, American College of Rheumatology.

  8. Outcome selection and role of patient reported outcomes in contemporary cardiovascular trials: systematic review

    PubMed Central

    Malhotra, Aneil; Banning, Adrian P; Jenkinson, Crispin

    2010-01-01

    Objectives To systematically assess the type of outcomes selected and the prevalence of patient reported outcomes in contemporary cardiovascular trials and to quantify any misuse or underuse of patient reported outcomes using a specially developed tool that would allow estimation of the relevance of such outcomes to clinical decision making. Design Systematic review. Data sources Medline and Embase. Study selection Randomised controlled trials of the treatment for or prevention of cardiovascular disease published in 10 leading general medical and cardiology journals from January 2005 to December 2008. Results Primary outcomes were patient important (death, morbidity, or patient reported outcomes) in only 93 of 413 trials (23%, SE 2%), whereas another 92 (22%, SE 2%) combined these outcomes with other less important ones into a composite. Sixty five trials (16%; SE 2%) used at least one instrument to measure patient reported outcomes, mostly in trials where such information would have been important or crucial for clinical decision making (52 trials). Patient reported outcomes were judged to be of little incremental value to a large number of, mostly explanatory, cardiovascular trials (152 trials). However, many trials in which patient reported outcomes would have been important or crucial for clinical decision making did not report such outcomes (122 of 174 trials, 70%). These included several trials that primarily aimed to improve symptoms or functional status, trials that tested interventions with a considerable potential for causing harm (mainly bleeding) that were not meaningfully measured, and trials with composite outcomes that were dominated by outcomes of questionable importance to patients. Conclusions Despite a continued rise in the reporting of patient reported outcomes with no evidence for their misuse in more recent cardiovascular trials, they seem to be still underused once their relevance to clinical decision making has been taken into account. This

  9. 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

  10. Increasing patient preparedness for sacral neuromodulation improves patient reported outcomes despite leaving objective measures of success unchanged.

    PubMed

    Firoozi, Farzeen; Gill, Bradley; Ingber, Michael S; Moore, Courtenay K; Rackley, Raymond R; Goldman, Howard B; Vasavada, Sandip P

    2013-08-01

    We assessed how a group shared appointment influenced patient preparedness for sacral nerve stimulation for refractory overactive bladder and/or urge urinary incontinence. We also evaluated subjective and objective outcomes. Patients considering sacral nerve stimulation were prospectively enrolled and invited to attend a group shared appointment. This 75-minute presentation included a question and answer period with an implanting surgeon and an implanted patient. Control patients received standard office counseling. A patient preparedness questionnaire was completed after the group shared appointment or office counseling. Response to treatment was determined using the postoperative satisfaction questionnaire, Patient Global Impression of Improvement (PGI-I) and voiding diaries. In our study 36 women with a mean ± SD age of 61 ± 15 years underwent sacral nerve stimulation. There was no significant difference in patient demographics between the 19 women who attended the group shared appointment and the 17 controls. Overall preparedness was greater in the shared appointment group (p = 0.043) with better understanding of the purpose of (p = 0.003) and alternatives to (p = 0.043) sacral nerve stimulation. Significantly more women in the shared appointment group than controls felt completely prepared (78.9% vs 29.4%, p = 0.003) and completely satisfied (78.9% vs 35.3%, p = 0.003) with sacral nerve stimulation as well as very much better (68.4% vs 17.6%, p = 0.002) according to the PGI-I. There was no difference between the groups in the number of women with a 50% or greater symptom reduction on voiding diary. Participating in a group shared appointment before sacral nerve stimulation improved patient preparedness and perceived outcomes of treatment, although there was no difference in objective outcomes based on voiding diary. Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  11. [Patient reported outcome monitoring using a tablet PC is suitable for measuring quality of life in patients with gliomas].

    PubMed

    Holzner, Bernhard; Schauer-Maurer, Gabriele; Stockhammer, Guenter; Muigg, Armin; Hutterer, Markus; Giesinger, Johannes

    2011-01-01

    A computer-based tool for the monitoring of patient-related outcomes, the "Computer-based Health Evaluation System" (CHES) was developed at the medical university of Innsbruck. The software-generated graphic QOL profiles were found to be an important tool for screening patients for clinically relevant problems and were successfully used in oncology, geriatrics, psychiatry, and psychosomatics. The authors report their experience with CHES in 34 patients with recurrent gliomas. The computer-based QoL monitoring was repeated in median 5.4 times per patients and found feasible and well accepted by patients and personnel.

  12. Comparison of Paper and Electronic Surveys for Measuring Patient-Reported Outcomes After Anterior Cruciate Ligament Reconstruction

    PubMed Central

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

    2014-01-01

    Objective: This study compared response rates of paper and electronic versions of the Knee injury Osteoarthritis and Outcome Score questionnaire and examined the characteristics of patients who responded to each survey method. Methods: A total of 1486 patients registered by the Kaiser Permanente Anterior Cruciate Ligament Reconstruction Registry between 2005 and 2010 were included in this study. Response rates by survey modality for the overall cohort, by the specific time periods, and by age and sex at time of anterior cruciate ligament reconstruction were compared using χ2 tests or the Fisher exact test when appropriate. Independent Student t tests were used to compare the Knee injury Osteoarthritis and Outcome Scores of survey respondents. Results: The overall survey response rate was 42%. The 36% response rate in the electronic-survey group was significantly higher than the 22% response rate in the paper-survey group (p < 0.001). The electronic response rate was also significantly higher than the paper response rate at all follow-up times (35% vs 25% at 1 year, p = 0.004, 38% vs 20% at 2 years, p < 0.001, and 35% vs 21% at 3 years; p < 0.001) and among all age groups 19 years and older. Conclusion: Although the electronic survey produced higher response rates, it is not sufficient alone to replace the traditional paper version among this Kaiser Permanente population. PMID:25102515

  13. Socioeconomic deprivation and age are barriers to the online collection of patient reported outcome measures in orthopaedic patients

    PubMed Central

    Jenkins, PJ; Sng, S; Brooksbank, K; Brooksbank, AJ

    2016-01-01

    Introduction Questionnaires are used commonly to assess functional outcome and satisfaction in surgical patients. Although these have in the past been administered through written forms, there is increasing interest in the use of new technology to improve the efficiency of collection. The aim of this study was to assess the availability of internet access for a group of orthopaedic patients and the acceptability of online survey completion. Methods A total of 497 patients attending orthopaedic outpatient clinics were surveyed to assess access to the internet and their preferred means for completing follow-up questionnaires. Results Overall, 358 patients (72%) reported having internet access. Lack of access was associated with socioeconomic deprivation and older age. Multivariable regression confirmed increased age and greater deprivation to be independently associated with lack of internet access. Out of the total group, 198 (40%) indicated a preference for assessment of outcomes via email and the internet. Conclusions Internet access was not universal among the patients in our orthopaedic clinic. Reliance on internet collection of PROMs may introduce bias by not including results from patients in older age groups and those from the more deprived socioeconomic groups. PMID:26688398

  14. 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.

  15. 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

  16. Patient-Reported Outcome Measures and Risk Factors in a Quality Registry: A Basis for More Patient-Centered Diabetes Care in Sweden

    PubMed Central

    Borg, Sixten; Palaszewski, Bo; Gerdtham, Ulf-G; Ödegaard, Fredrik; Roos, Pontus; Gudbjörnsdottir, Soffia

    2014-01-01

    Diabetes is one of the chronic diseases that constitute the greatest disease burden in the world. The Swedish National Diabetes Register is an essential part of the diabetes care system. Currently it mainly records clinical outcomes, but here we describe how it has started to collect patient-reported outcome measures, complementing the standard registry data on clinical outcomes as a basis for evaluating diabetes care. Our aims were to develop a questionnaire to measure patient abilities and judgments of their experience of diabetes care, to describe a Swedish diabetes patient sample in terms of their abilities, judgments, and risk factors, and to characterize groups of patients with a need for improvement. Patient abilities and judgments were estimated using item response theory. Analyzing them together with standard risk factors for diabetes comorbidities showed that the different types of data describe different aspects of a patient’s situation. These aspects occasionally overlap, but not in any particularly useful way. They both provide important information to decision makers, and neither is necessarily more relevant than the other. Both should therefore be considered, to achieve a more complete evaluation of diabetes care and to promote person-centered care. PMID:25431875

  17. Patient-reported outcome measures and risk factors in a quality registry: a basis for more patient-centered diabetes care in Sweden.

    PubMed

    Borg, Sixten; Palaszewski, Bo; Gerdtham, Ulf-G; Fredrik, Odegaard; Roos, Pontus; Gudbjörnsdottir, Soffia

    2014-11-26

    Diabetes is one of the chronic diseases that constitute the greatest disease burden in the world. The Swedish National Diabetes Register is an essential part of the diabetes care system. Currently it mainly records clinical outcomes, but here we describe how it has started to collect patient-reported outcome measures, complementing the standard registry data on clinical outcomes as a basis for evaluating diabetes care. Our aims were to develop a questionnaire to measure patient abilities and judgments of their experience of diabetes care, to describe a Swedish diabetes patient sample in terms of their abilities, judgments, and risk factors, and to characterize groups of patients with a need for improvement. Patient abilities and judgments were estimated using item response theory. Analyzing them together with standard risk factors for diabetes comorbidities showed that the different types of data describe different aspects of a patient's situation. These aspects occasionally overlap, but not in any particularly useful way. They both provide important information to decision makers, and neither is necessarily more relevant than the other. Both should therefore be considered, to achieve a more complete evaluation of diabetes care and to promote person-centered care.

  18. [Brazilian-Portuguese translation and cultural adaptation of the sleep and wake disturbances domains of the Patient-Reported-Outcomes Measurement Information System (PROMIS)].

    PubMed

    Silva E Costa, Zilma Maria Severino; Pinto, Rogério de Melo Costa; Mendonça, Tânia Maria da Silva; Silva, Carlos Henrique Martins da

    2014-07-01

    Altered sleep and wakefulness affect individuals' mood, memory, and psychomotor performance and thus directly impact their quality of life. Tools to analyze the quality of these factors should be available for clinical evaluation. This study aimed to translate into Brazilian Portuguese and culturally adapt the Patient-Reported Outcomes Measurement Information System (PROMIS), specifically the sleep and wake disturbances domains. The translation and cultural adaptation processes followed the guidelines proposed by the Functional Assessment of Chronic Illness Therapy (FACIT) organization. The methodology included translation, reconciliation, back-translation, review by PROMIS, review by independent reviewers, pretest, and incorporation of the results into the final version. The Portuguese version of the sleep and wake disturbances domains presents semantic, idiomatic, cultural, and conceptual equivalence with the items in the source language.

  19. [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.

  20. Impact of Adherence to Quality Measures for Localized Prostate Cancer on Patient-reported Health-related Quality of Life Outcomes, Patient Satisfaction, and Treatment-related Complications.

    PubMed

    Sohn, William; Resnick, Matthew J; Greenfield, Sheldon; Kaplan, Sherrie H; Phillips, Sharon; Koyama, Tatsuki; Goodman, Michael; Hamilton, Ann S; Hashibe, Mia; Hoffman, Karen E; Paddock, Lisa E; Stroup, Antoinette M; Wu, Xiao-Cheng; Penson, David F; Barocas, Daniel A

    2016-08-01

    Quality measures used in pay-for-performance systems are intended to address specific quality goals, such as safety, efficiency, effectiveness, timeliness, equity, and patient-centeredness. Given the small number of narrowly focused measures in prostate cancer care, we sought to determine whether adherence to any of the available payer-driven quality measures influences patient-centered outcomes, including health-related quality of life (HRQOL), patient satisfaction, and treatment-related complications. The Comparative Effectiveness Analysis of Surgery and Radiation study is a population-based, prospective cohort study that enrolled 3708 men with clinically localized prostate cancer during 2011 and 2012, of whom 2601 completed the 1-year survey and underwent complete chart abstraction. Compliance with 6 quality indicators endorsed by national consortia was assessed. Multivariable regression was used to determine the relationship between indicator compliance and Expanded Prostate Cancer Index Composite (EPIC-26) instrument summary scores, satisfaction scale scores (service satisfaction scale for cancer care), and treatment-related complications. Overall rates of compliance with these quality measures ranged between 64% and 88%. Three of the 6 measures were weakly associated with 1-year sexual function and bowel function scores (β=-4.6, 1.69, and 2.93, respectively; P≤0.05), whereas the remaining measures had no significant relationship with patient-reported HRQOL outcomes. Satisfaction scores and treatment-related complications were not associated with quality measure compliance. Compliance with available nationally endorsed quality indicators, which were designed to incentivize effective and efficient care, was not associated with clinically important changes in patient-centered outcomes (HRQOL, satisfaction, or complications) within 1-year.

  1. Development of a patient-centred, patient-reported outcome measure (PROM) for post-stroke cognitive rehabilitation: qualitative interviews with stroke survivors to inform design and content.

    PubMed

    Patchick, Emma L; Horne, Maria; Woodward-Nutt, Kate; Vail, Andy; Bowen, Audrey

    2015-12-01

    Improving cognition is service users' top research priority for life after stroke, and future research should include outcomes that they deem important. Patient perspectives on outcomes are collected using patient-reported outcome measures (PROMs). There is currently no patient-centred PROM specific for cognitive rehabilitation trials. Inform PROM development by exploring stroke survivor perspectives on the important, measurable impacts of persisting post-stroke cognitive problems. Qualitative semi-structured interviews in participants' homes. Purposive sample of 16 cognitively impaired stroke survivors at least six months post-stroke. Interviews used a schedule and communication aids developed through patient consultation. Interviews were transcribed verbatim with non-verbal communication recorded using field notes. Data were analysed using a framework approach to find commonalities to shape the focus and content of an outcome measure. Participants identified important impacts of their 'invisible' cognitive problems, outside of other stroke-related impairments. Cognitive problems exacerbated emotional issues and vice versa. Changes in self-identity and social participation were prominent. Impact was not spoken about in terms of frequency but rather in terms of the negative affect associated with problems; terms like 'bothered' and 'frustration' were often used. The results support the development of a PROM specifically designed to address the impact of cognitive problems. It should: include items addressing a comprehensive range of cognitive skills; ask questions about mood, self-identity and social participation; use accessible wording that respondents understand and endorse; measure impact rather than frequency; and explore perceived impact on carers. © 2014 John Wiley & Sons Ltd.

  2. A five year experience of measuring clinical effectiveness in a breast reconstruction service using the BREAST-Q patient reported outcomes measure: A cohort study.

    PubMed

    Dean, Nicola R; Crittenden, Tamara

    2016-11-01

    To assess the clinical effectiveness of breast reconstruction and the utility of the BREAST-Q patient-reported outcomes measure for routine patient care. The BREAST-Q was administered to all patients attending a breast reconstructive service (n = 343) at a University Hospital at each visit. The BREAST-Q was easy to administer in a clinic setting, with a high participation rate (64.2% completing the minimum dataset of three BREAST-Qs). Pre-operatively, women with invasive cancer scored lower than those with DCIS or high-risk status (eg. mean psychosocial well-being scores 51.45 vs 63.74 vs 65.56, p < 0.05). At six months post-mound reconstruction the mean values for immediate and delayed timing of reconstruction were similar, with the change in quality of life from pre-reconstruction to this time-point post-reconstruction being greater in the delayed group (eg. mean improvement in psychosocial well-being scores for immediate 8.90 vs delayed 19.87, p < 0.05). Women with autologous flaps had greater improvements than women with implant-based reconstruction (eg. mean increase in psychosocial well-being scores 20.29 vs 9.58, p < 0.05). Breast reconstruction was highly effective in terms of improving psychosocial (mean pre-op 55.44 vs post-op 71.47, p < 0.001), physical (mean pre-op 69.82 vs post-op 74.78, p < 0.001), and sexual well-being (mean pre-op 38.74 vs post-op 54.17, p < 0.001), as well as satisfaction with breasts (mean pre-op 44.99 vs post-op 64.92, p < 0.001), in this non-selected cohort of patients. Breast reconstruction is highly effective in improving the well-being of women undergoing mastectomy. The BREAST-Q is well suited for clinical effectiveness research and easily incorporated into routine patient care. Crown Copyright © 2016. Published by Elsevier Ltd. All rights reserved.

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2013-01-01

    Patient-reported outcome measures (PROMs) are intended to reflect outcomes relevant to patients. They are increasingly used for healthcare quality improvement. To produce valid measures, patients should be involved in the development process but it is unclear whether this usually includes people with low literacy skills or learning disabilities. This potential exclusion raises concerns about whether these groups will be able to use these measures and participate in quality improvement practices. Taking PROMs for chronic obstructive pulmonary disease (COPD) as an exemplar condition, our review determined the inclusion of people with low literacy skills and learning disabilities in research developing, validating, and using 12 PROMs for COPD patients. The studies included in our review were based on those identified in two existing systematic reviews and our update of this search. People with low literacy skills and/or learning disabilities were excluded from the development of PROMs in two ways: explicitly through the participant eligibility criteria and, more commonly, implicitly through recruitment or administration methods that would require high-level reading and cognitive abilities. None of the studies mentioned efforts to include people with low literacy skills or learning disabilities. Our findings suggest that people with low literacy skills or learning disabilities are left out of the development of PROMs. Given that implicit exclusion was most common, researchers and those who administer PROMs may not even be aware of this problem. Without effort to improve inclusion, unequal quality improvement practices may become embedded in the health system.

  5. Development of a patient reported outcome measure for fatigue in motor neurone disease: the Neurological Fatigue Index (NFI-MND)

    PubMed Central

    2011-01-01

    Background The objective of this research was to develop a disease-specific measure for fatigue in patients with motor neurone disease (MND) by generating data that would fit the Rasch measurement model. Fatigue was defined as reversible motor weakness and whole-body tiredness that was predominantly brought on by muscular exertion and was partially relieved by rest. Methods Qualitative interviews were undertaken to confirm the suitability of a previously identified set of 52 neurological fatigue items as relevant to patients with MND. Patients were recruited from five U.K. MND clinics. Questionnaires were administered during clinic or by post. A sub-sample of patients completed the questionnaire again after 2-4 weeks to assess test-retest validity. Exploratory factor analyses and Rasch analysis were conducted on the item set. Results Qualitative interviews with ten MND patients confirmed the suitability of 52 previously identified neurological fatigue items as relevant to patients with MND. 298 patients consented to completing the initial questionnaire including this item set, with an additional 78 patients completing the questionnaire a second time after 4-6 weeks. Exploratory Factor Analysis identified five potential subscales that could be conceptualised as representing: 'Energy', 'Reversible muscular weakness' (shortened to 'Weakness'), 'Concentration', 'Effects of heat' and 'Rest'. Of the original five factors, two factors 'Energy' and 'Weakness' met the expectations of the Rasch model. A higher order fatigue summary scale, consisting of items from the 'Energy' and 'Weakness' subscales, was found to fit the Rasch model and have acceptable unidimensionality. The two scales and the higher order summary scale were shown to fulfil model expectations, including assumptions of unidimensionality, local independency and an absence of differential item functioning. Conclusions The Neurological Fatigue Index for MND (NFI-MND) is a simple, easy-to-administer fatigue

  6. Measuring Patient Safety in Primary Care: The Development and Validation of the “Patient Reported Experiences and Outcomes of Safety in Primary Care” (PREOS-PC)

    PubMed Central

    Ricci-Cabello, Ignacio; Avery, Anthony J.; Reeves, David; Kadam, Umesh T.; Valderas, Jose M.

    2016-01-01

    PURPOSE We set out to develop and validate a patient-reported instrument for measuring experiences and outcomes related to patient safety in primary care. METHOD The instrument was developed in a multistage process supported by an international expert panel and informed by a systematic review of instruments, a meta-synthesis of qualitative studies, 4 patient focus groups, 18 cognitive interviews, and a pilot study. The trial version of Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) covered 5 domains and 11 scales: practice activation (1 scale); patient activation (1 scale); experiences of patient safety events (1 scale); harm (6 scales); and general perceptions of patient safety (2 scales). The questionnaire was posted to 6,736 patients in 45 practices across England. We used “gold standard” psychometric methods to evaluate its acceptability, reliability, structural and construct validity, and ability to discriminate among practices. RESULTS 1,244 completed questionnaires (18.5%) were returned. Median item-specific response rate was 91.3% (interquartile range 28.0%). No major ceiling or floor effects were observed. All 6 multi-item scales showed high internal consistency (Cronbach’s α 0.75–0.96). Factor analysis, correlation between scales, and known group analyses generally supported structural and construct validity. The scales demonstrated a heterogeneous ability to discriminate between practices. The final version of PREOS-PC consisted of 5 domains, 8 scales, and 58 items. CONCLUSIONS PREOS-PC is a new multi-dimensional patient safety instrument for primary care developed with experts and patients. Initial testing shows its potential for use in primary care, and future developments will further address its use in actual clinical practice. PMID:27184996

  7. Concept Elicitation Phase for the Pediatric Patient-Reported Outcome Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Measure Development

    PubMed Central

    Weaver, Meaghann; Reeve, Bryce; Baker, Justin; Martens, Christa; McFatrich, Molly; Mowbray, Catriona; Palma, Diana; Sung, Lillian; Tomlinson, Deborah; Withycombe, Janice; Hinds, Pamela

    2015-01-01

    Background Symptoms arising from disease or treatment are subjective experiences. Insight into pediatric oncology treatment side effects or symptoms is ideally obtained from direct inquiry to the ill child. A concept elicitation phase in a patient-reported outcome instrument design provides opportunity to elicit children's voices to shape cancer symptom selection and terminology. Methods Symptom data were collected from 96 children with cancer, ages 7-20 years undergoing oncologic treatment at seven pediatric oncology sites in the United States and Canada through semi-structured, one-on-one, voice-recorded interviews. Results The mean number of symptoms reported per child over the prior seven days was 1.49 (range 0-7, median 1, SD 1.56). The most common symptoms across all age groups were: feeling tired or fatigue, nausea or vomiting, aches or pains, and weakness. There was not a statistically significant correlation between self-reported wellness and the number of symptoms reported (r= -0.156, n = 65, p = 0.215) or the number of symptoms reported based on age group or diagnosis type. Forty participants reported experiencing a change in their body in the past week with one-third of these changes unanticipated. Only by directly asking about feelings were emotional symptoms revealed, as 90.6% of interviewees who discussed feelings (n=48/53) did so only in the context of direct questioning on feelings. Adolescents were more likely than younger children to discuss feelings as part of the interview. Conclusion(s) Concept elicitation, from children and adolescents, has the potential to enable researchers to develop age-appropriate, accurately representative patient-reported outcome measures. PMID:26421973

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

    PubMed

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

    2016-03-01

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

  9. 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

  10. Loss to follow-up after total hip replacement: a source of bias in patient reported outcome measures and registry datasets?

    PubMed

    Imam, Mohamed A; Barke, Samuel; Stafford, Giles H; Parkin, David; Field, Richard E

    2014-01-01

    Patient reported outcome measures (PROMs) are used to gauge clinical performance. The PROMs outcome programme at our centre achieves a preoperative data capture rate of 99%. This falls to 90.6%, 89%, 83% and 79% at the six-week, six-month, one-year and two-year time points, respectively. The study aims were to determine factors associated with patients who did not respond to outcome questionnaires following total hip replacement (THR), and the potential implications this may have when assessing patients following THRs. During the first year of the PROMs programme, 1,322 patients underwent unilateral primary THR at our institution. Of these, 1,311 completed preoperative questionnaires. Thirty-eight patients (2.9%) died within two years of surgery and have been excluded. For the remaining 1,273 patients, we identified those who did not return postoperative questionnaires at each of our review time points. Younger age, lower baseline EQ5D and Oxford Hip scores (OHS) were significantly associated with non-response (p<0.001). Patients with lower satisfaction scores, OHS and EQ5D scores, were less likely to respond to subsequent questionnaires. A significant association between non-response and deprivation (p<0.001) was demonstrated. Our findings suggest that the more satisfied patients are over-represented and our reported outcome results are better than they would have been if all patients had responded. This phenomenon may apply to studies where those categorised as "lost to follow-up" represent a subset of patients who have disengaged due to poor outcome or satisfaction.

  11. The Munich Wrist Questionnaire (MWQ) - development and validation of a new patient-reported outcome measurement tool for wrist disorders.

    PubMed

    Beirer, Marc; Serly, Julian; Vester, Helen; Pförringer, Dominik; Crönlein, Moritz; Deiler, Stephan; Biberthaler, Peter; Kirchhoff, Chlodwig

    2016-04-14

    Although self-assessment questionnaires for the wrist joint are numerous, most validation studies focus on a specific pathology and patient collectives. In addition the available questionnaires focus on subjective parameters such as pain, usual and specific activities but the range of motion (ROM) as an essential objective parameter in wrist disorders is rarely considered. Therefore the purpose of the presented study was to develop and validate a new universally applicable self-assessment score, the Munich Wrist Questionnaire (MWQ), which allows for the assessment of subjective as well as objective parameters of the wrist joint. The MWQ consists of 16 items addressing three domains: pain, work and activities of daily living and wrist function including range of motion and grip strength. In a prospective clinical study validity, reliability and responsiveness of the MWQ of physical active patients were evaluated. Validation study included 100 patients (mean age 41 years, SD 16.3 years; range, 18-77 years). Test-retest reliability was substantial, with intraclass correlation coefficients ranging from 0.75 to 0.83 for the three domains. Construct validity and responsiveness were confirmed by correlation coefficients of at least 0.86 for construct validity and for responsiveness ranging from 0.61 to 0.65. The MWQ presents a valid and reliable instrument for a qualitative self-assessment of subjective and objective parameters (e.g. range of motion) of the wrist joint. Quantitative measurement of wrist function may not longer be limited to specific wrist disorders or patient groups. The MWQ seems to allow for a broad application in clinical research and may facilitate the comparison of treatment results in wrist disorders.

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

    PubMed

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

    2015-04-01

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

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

    PubMed

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

    2014-05-10

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

  14. Patient-Reported Outcomes and Fibromyalgia.

    PubMed

    Williams, David A; Kratz, Anna L

    2016-05-01

    Fibromyalgia (FM) is classified as a chronic pain condition accompanied by symptoms of fatigue, sleep problems, problems with cognition, negative mood, limited functional status, and the presence of other chronic overlapping pain conditions. Comprehensive assessment of all of these components can be challenging. This paper provides an overview of patient-reported approaches that can be taken to assess FM in the contexts of diagnosis, symptom monitoring, phenotyping/characterization, and for purposes of clinical trials.

  15. The Examination of Patient-Reported Outcomes and Postural Control Measures in Patients with and without a History of ACL Reconstruction: a Case Control Study.

    PubMed

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

    2017-03-02

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

  16. The routine collection of patient-reported outcome measures (PROMs) for long-term conditions in primary care: a cohort survey

    PubMed Central

    Peters, Michele; Crocker, Helen; Jenkinson, Crispin; Doll, Helen; Fitzpatrick, Ray

    2014-01-01

    Objectives To evaluate the feasibility of using patient-reported outcome measures (PROMs) for long-term conditions (LTCs) in primary care. Design A cohort postal survey conducted from September 2010 to April 2012. Setting Primary care practices (n=33) in London and the North-West of England. Participants 4484 patients with a diagnosis of asthma, chronic obstructive pulmonary disease, diabetes, epilepsy, heart failure or stroke were sent a survey at baseline. Main outcome The main outcome was to evaluate the feasibility of and the recruitment strategies for collecting PROMs data in LTCs by assessing the response rates for the baseline and follow-up surveys. Secondary outcomes were the evaluation of change scores of the EQ-5D index and visual analogue scale (VAS) between baseline and follow-up surveys. Results The baseline survey achieved a response rate of 38.4% (n=1721/4485) and at follow-up 71.5% (n=1136/1589). Response rates varied by LTC. Little change was found in health-related quality of life for the total sample (−0.001 for the EQ-5D index score and 0.12 for the EQ-5D VAS) between patients responding to both the baseline and follow-up surveys. Conclusions The response rate to the baseline survey was similar to that of other general practice surveys. Current UK policy aims to assess health service performance in LTCs by means of using PROMs. It thus would be desirable to improve response rates by making the invitation to self-reports of health-related quality of life more engaging for patients. Results on the EQ-5D score raise questions about optimal indicators for LTCs and appropriate timelines for assessment. PMID:24561495

  17. Concept analysis of the patient reported outcomes measurement information system (PROMIS(®)) and the international classification of functioning, disability and health (ICF).

    PubMed

    Tucker, Carole A; Cieza, Alarcos; Riley, Anne W; Stucki, Gerold; Lai, Jin Shei; Bedirhan Ustun, T; Kostanjsek, Nenad; Riley, William; Cella, David; Forrest, Christopher B

    2014-08-01

    The Patient Reported Outcomes Measurement Information System (PROMIS (®) ) is a US National Institutes of Health initiative that has produced self-report outcome measures, using a framework of physical, mental, and social health defined by the World Health Organization in 1948 (WHO, in Preamble to the Constitution of the World Health Organization as adopted by the International Health Conference, New York, 1948). The World Health Organization's International Classification of Functioning, Disability and Health (ICF) is a comprehensive classification system of health and health-related domains that was put forward in 2001. The purpose of this report is to compare and contrast PROMIS and ICF conceptual frameworks to support mapping of PROMIS instruments to the ICF classification system . We assessed the objectives and the classification schema of the PROMIS and ICF frameworks, followed by content analysis to determine whether PROMIS domain and sub-domain level health concepts can be linked to the ICF classification. Both PROMIS and ICF are relevant to all individuals, irrespective of the presence of health conditions, person characteristics, or environmental factors in which persons live. PROMIS measures are intended to assess a person's experiences of his or her health, functional status, and well-being in multiple domains across physical, mental, and social dimensions. The ICF comprehensively describes human functioning from a biological, individual, and social perspective. The ICF supports classification of health and health-related states such as functioning, but is not a specific measure or assessment of health, per se. PROMIS domains and sub-domain concepts can be meaningfully mapped to ICF concepts. Theoretical and conceptual similarities support the use of PROMIS instruments to operationalize self-reported measurement for many body function, activity and participation ICF concepts, as well as several environmental factor concepts. Differences observed in

  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. Patient reported outcomes and patient empowerment in clinical genetics services.

    PubMed

    McAllister, M; Dearing, A

    2015-08-01

    Evaluation of clinical genetics services (CGS), including genetic counseling and genetic testing, has been problematic. Patient mortality and morbidity are unlikely to be directly improved by interventions offered in CGS. Patient-reported outcomes (PROs) are not routinely measured in CGS evaluation, but this may change as patient-reported outcome measures (PROMs) become a key part of how healthcare services are managed and funded across the world. However, there is no clear consensus about which PROMs are most useful for CGS evaluation. This review summarizes the published research on how PROs from CGS have been measured and how patients may benefit from using those services, with a focus on patient empowerment. Many patient benefits (PROs) identified repeatedly in the research literature can be re-interpreted within a patient empowerment framework. Other important PROs identified include family functioning, social functioning, altruism, sense of purpose, enabling development of future research and treatment/participating in research. Well-validated measures are available to capture (dimensions of) patient empowerment. Although generic measures of family functioning are available, suitable measures capturing social functioning, development of future treatments, and altruism were not identified in this review. Patient empowerment provides one useful approach to measuring PROs from CGS.

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

    PubMed Central

    2014-01-01

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

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

    PubMed

    Watt, Torquil; Barbesino, Giuseppe; Bjorner, Jakob Bue; Bonnema, Steen Joop; Bukvic, Branka; Drummond, Russell; Groenvold, Mogens; Hegedüs, Laszlo; Kantzer, Valeska; Lasch, Kathryn E; Marcocci, Claudio; Mishra, Anjali; Netea-Maier, Romana; Ekker, Merel; Paunovic, Ivan; Quinn, Terence J; Rasmussen, Åse Krogh; Russell, Audrey; Sabaretnam, Mayilvaganan; Smit, Johannes; Törring, Ove; Zivaljevic, Vladan; Feldt-Rasmussen, Ulla

    2015-03-01

    Thyroid diseases are common and often affect quality of life (QoL). No cross-culturally validated patient-reported outcome measuring thyroid-related QoL is available. The purpose of the present study was to test the cross-cultural validity of the newly developed thyroid-related patient-reported outcome ThyPRO, using tests for differential item functioning (DIF) according to language version. The ThyPRO consists of 85 items summarized in 13 multi-item scales and one single item. Scales cover physical and mental symptoms, well-being and function as well as social and daily function and cosmetic concerns. Translation applied standard forward-backward methodology with subsequent cognitive interviews and reviews. Responses (N = 1,810) to the ThyPRO were collected in seven countries: UK (n = 166), The Netherlands (n = 147), Serbia (n = 150), Italy (n = 110), India (n = 148), Denmark (n = 902) and Sweden (n = 187). Translated versions were compared pairwise to the English version by examining uniform and nonuniform DIF, i.e., whether patients from different countries respond differently to a particular item, although they have identical level of the concept measured by the item. Analyses were controlled for thyroid diagnosis. DIF was investigated by ordinal logistic regression, testing for both statistical significance and magnitude (ΔR (2) > 0.02). Scale level was estimated by the sum score, after purification. For twelve of the 84 tested items, DIF was identified in more than one language. Eight of these were small, but four were indicative of possible low translatability. Twenty-one instances of DIF in single languages were identified, indicating potential problems with the particular translation. However, only seven were of a magnitude which could affect scale scores, most of which could be explained by sample differences not controlled for. The ThyPRO has good cross-cultural validity with only minor cross-cultural invariance and is recommended for use in

  2. Associations between a patient reported outcome (PRO) measure of sarcopenia and falls, functional status, and physical performance in older patients with cancer

    PubMed Central

    Gewandter, Jennifer S.; Dale, William; Magnuson, Allison; Pandya, Chintan; Heckler, Charles E.; Lemelman, Tatyana; Roussel, Breton; Ifthikhar, Rafa; Dolan, James; Noyes, Katia; Mohile, Supriya G.

    2015-01-01

    Objective In older patients with cancer, we aimed to investigate associations between a patient-reported outcome measure for sarcopenia (SarcoPRO) and the Short Physical Performance Battery (SPPB), self-reported falls, and limitations in instrumental activities of daily living (IADLs). Materials and Methods Assessments were conducted as part of the initial evaluation of older, often frail, patients with cancer seen in the Specialized Oncology Care and Research in the Elderly (SOCARE) clinic. Univariate associations were evaluated using Spearman’s correlation and Wilcoxon sign ranked tests. Logistic regressions were used to identify associations of clinical factors and SarcoPRO scores or SPPB scores with falls and IADL limitations. Results In total, 174 older patients with cancer were evaluated. A moderate correlation was found between the SarcoPRO and the SPPB (ρ = 0.62). After adjusting for multiple clinical factors, neither the SarcoPRO nor the SPPB were associated with falls. In contrast, both higher SarcoPRO (i.e., worse) and lower SPPB (i.e., worse) scores were associated with limitations in IADLs (Odds ratio for one unit change in predictor: SarcoPRO: 1.06, p<0.0001; SPPB: 0.71, p = 0.003, respectively). Models using the SarcoPRO and SPPB explained similar amounts of variability in association with IADL limitations (AUC: 0.88 vs 0.87, respectively). Conclusions The SarcoPRO was moderately associated with the SPPB, an objective measure of physical performance, and was associated with limitations in IADLs. Thus, older patients with cancer who present with IADL limitations should be screened for sarcopenia. The SarcoPRO shows promise as a measure for screening as well as outcome assessment for research on sarcopenia. PMID:26365897

  3. Ecological Validity and Clinical Utility of Patient-Reported Outcomes Measurement Information System (PROMIS®) instruments for detecting premenstrual symptoms of depression, anger, and fatigue

    PubMed Central

    Junghaenel, Doerte U.; Schneider, Stefan; Stone, Arthur A.; Christodoulou, Christopher; Broderick, Joan E.

    2014-01-01

    Objective This study examined the ecological validity and clinical utility of NIH Patient Reported-Outcomes Measurement Information System (PROMIS®) instruments for anger, depression, and fatigue in women with premenstrual symptoms. Methods One-hundred women completed daily diaries and weekly PROMIS assessments over 4 weeks. Weekly assessments were administered through Computerized Adaptive Testing (CAT). Weekly CATs and corresponding daily scores were compared to evaluate ecological validity. To test clinical utility, we examined if CATs could detect changes in symptom levels, if these changes mirrored those obtained from daily scores, and if CATs could identify clinically meaningful premenstrual symptom change. Results PROMIS CAT scores were higher in the pre-menstrual than the baseline (ps < .0001) and post-menstrual (ps < .0001) weeks. The correlations between CATs and aggregated daily scores ranged from .73 to .88 supporting ecological validity. Mean CAT scores showed systematic changes in accordance with the menstrual cycle and the magnitudes of the changes were similar to those obtained from the daily scores. Finally, Receiver Operating Characteristic (ROC) analyses demonstrated the ability of the CATs to discriminate between women with and without clinically meaningful premenstrual symptom change. Conclusions PROMIS CAT instruments for anger, depression, and fatigue demonstrated validity and utility in premenstrual symptom assessment. The results provide encouraging initial evidence of the utility of PROMIS instruments for the measurement of affective premenstrual symptoms. PMID:24630180

  4. Confirmatory Factor Analysis of the Patient-Reported Outcomes Measurement Information System (PROMIS) Adult Domain Framework Using Item Response Theory Scores

    PubMed Central

    Carle, Adam Christopher; Riley, William; Hays, Ron D.; Cella, David

    2016-01-01

    Background To guide measure development, National Institutes of Health (NIH)-supported Patient Reported Outcomes Measurement Information System (PROMIS®) investigators developed a hierarchical domain framework. The framework specifies health domains at multiple levels. The initial PROMIS domain framework specified that physical function and symptoms such as pain and fatigue indicate Physical Health (PH); depression, anxiety, and anger indicate Mental Health (MH); and social role performance and social satisfaction indicate Social Health (SH). We used confirmatory factor analyses (CFA) to evaluate the fit of the hypothesized framework to data collected from a large sample. Methods We used data (n = 14,098) from PROMIS’s wave 1 field test and estimated domain scores using the PROMIS item response theory parameters. We then used CFA to test whether the domains corresponded to the PROMIS domain framework as expected. Results A model corresponding to the domain framework did not provide ideal fit (RMSEA=0.13; CFI=0.92; TLI=0.88; SRMR=0.09). Based on modification indices and EFA, we allowed Fatigue to load on both PH and MH. This model fit the data acceptably (RMSEA=0.08; CFI=0.97; TLI=0.96; SRMR=0.03). Discussion Our findings generally support the PROMIS domain framework. Allowing fatigue to load on both PH and MH improved fit considerably. PMID:26366521

  5. A systematic review of the impact of routine collection of patient reported outcome measures on patients, providers and health organisations in an oncologic setting

    PubMed Central

    2013-01-01

    Background Despite growing interest and urges by leading experts for the routine collection of patient reported outcome (PRO) measures in all general care patients, and in particular cancer patients, there has not been an updated comprehensive review of the evidence regarding the impact of adopting such a strategy on patients, service providers and organisations in an oncologic setting. Methods Based on a critical analysis of the three most recent systematic reviews, the current systematic review developed a six-method strategy in searching and reviewing the most relevant quantitative studies between January 2000 and October 2011 using a set of pre-determined inclusion criteria and theory-based outcome indicators. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system was used to rate the quality and importance of the identified publications, and the synthesis of the evidence was conducted. Results The 27 identified studies showed strong evidence that the well-implemented PROs improved patient-provider communication and patient satisfaction. There was also growing evidence that it improved the monitoring of treatment response and the detection of unrecognised problems. However, there was a weak or non-existent evidence-base regarding the impact on changes to patient management and improved health outcomes, changes to patient health behaviour, the effectiveness of quality improvement of organisations, and on transparency, accountability, public reporting activities, and performance of the health care system. Conclusions Despite the existence of significant gaps in the evidence-base, there is growing evidence in support of routine PRO collection in enabling better and patient-centred care in cancer settings. PMID:23758898

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

    PubMed

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

    2017-02-01

    Cancer and its treatment lead to increased financial distress for patients. To the authors' knowledge, to date, no standardized patient-reported outcome measure has been validated to assess this distress. Patients with AJCC Stage IV solid tumors receiving chemotherapy for at least 2 months were recruited. Financial toxicity was measured by the COmprehensive Score for financial Toxicity (COST) measure. The authors collected data regarding patient characteristics, clinical trial participation, health care use, willingness to discuss costs, psychological distress (Brief Profile of Mood States [POMS]), and health-related quality of life (HRQOL) as measured by the Functional Assessment of Cancer Therapy: General (FACT-G) and the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaires. Test-retest reliability, internal consistency, and validity of the COST measure were assessed using standard-scale construction techniques. Associations between the resulting factors and other variables were assessed using multivariable analyses. A total of 375 patients with advanced cancer were approached, 233 of whom (62.1%) agreed to participate. The COST measure demonstrated high internal consistency and test-retest reliability. Factor analyses revealed a coherent, single, latent variable (financial toxicity). COST values were found to be correlated with income (correlation coefficient [r] = 0.28; P<.001), psychosocial distress (r = -0.26; P<.001), and HRQOL, as measured by the FACT-G (r = 0.42; P<.001) and by the EORTC QOL instruments (r = 0.33; P<.001). Independent factors found to be associated with financial toxicity were race (P = .04), employment status (P<.001), income (P = .003), number of inpatient admissions (P = .01), and psychological distress (P = .003). Willingness to discuss costs was not found to be associated with the degree of financial distress (P = .49). The COST measure demonstrated reliability and

  7. Upper-Extremity and Mobility Subdomains From the Patient-Reported Outcomes Measurement Information System (PROMIS) Adult Physical Functioning Item Bank

    PubMed Central

    Hays, Ron D.; Spritzer, Karen L.; Amtmann, Dagmar; Lai, Jin-Shei; DeWitt, Esi Morgan; Rothrock, Nan; DeWalt, Darren A.; Riley, William T.; Fries, James F.; Krishnan, Eswar

    2013-01-01

    Objective To create upper-extremity and mobility subdomain scores from the Patient-Reported Outcomes Measurement Information System (PROMIS) physical functioning adult item bank. Design Expert reviews were used to identify upper-extremity and mobility items from the PROMIS item bank. Psychometric analyses were conducted to assess empirical support for scoring upper-extremity and mobility subdomains. Setting Data were collected from the U.S. general population and multiple disease groups via self-administered surveys. Participants The sample (N=21,773) included 21,133 English-speaking adults who participated in the PROMIS wave 1 data collection and 640 Spanish-speaking Latino adults recruited separately. Interventions Not applicable. Main Outcome Measures We used English- and Spanish-language data and existing PROMIS item parameters for the physical functioning item bank to estimate upper-extremity and mobility scores. In addition, we fit graded response models to calibrate the upper-extremity items and mobility items separately, compare separate to combined calibrations, and produce subdomain scores. Results After eliminating items because of local dependency, 16 items remained to assess upper extremity and 17 items to assess mobility. The estimated correlation between upper extremity and mobility was .59 using existing PROMIS physical functioning item parameters (r=.60 using parameters calibrated separately for upper-extremity and mobility items). Conclusions Upper-extremity and mobility subdomains shared about 35% of the variance in common, and produced comparable scores whether calibrated separately or together. The identification of the subset of items tapping these 2 aspects of physical functioning and scored using the existing PROMIS parameters provides the option of scoring these subdomains in addition to the overall physical functioning score. PMID:23751290

  8. Development and validation of a patient-reported outcome measure in vitiligo: The Self Assessment Vitiligo Extent Score (SA-VES).

    PubMed

    van Geel, Nanja; Lommerts, Janny E; Bekkenk, Marcel W; Prinsen, Cecilia A C; Eleftheriadou, Viktoria; Taieb, Alain; Picardo, Mauro; Ezzedine, Khaled; Wolkerstorfer, Albert; Speeckaert, Reinhart

    2017-03-01

    The Vitiligo Extent Score (VES) has recently been introduced as a physicians' score for the clinical assessment of the extent of vitiligo, but a good patient self-assessment score is lacking. The objective is to develop and validate a simplified version of the VES as a patient-reported outcome measure (PROM). After extensive pilot testing, patients were asked to score their vitiligo extent twice with an interval of 2 weeks using the Self Assessment Vitiligo Extent Score (SA-VES). The scores were compared with the physicians' evaluation (VES). The SA-VES demonstrated very good test-retest reliability (intraclass correlation = 0.948, 95% confidence interval [CI]: 0.911-0.970) that was not affected by age, skin type, or vitiligo distribution pattern. According to patients, this evaluation method was easy to use (22% very easy; 49% easy; 29% normal) and required <5 minutes in the majority of patients (73%, <5 minutes; 24%, 5-10 minutes; 2%, 10-15 minutes). Comparison of the SA-VES and the VES demonstrated excellent correlation (r = 0.986, P <.001). Few patients had a dark skin type. The results demonstrate excellent reliability of the SA-VES and excellent correlation with its investigator-reported counterpart (VES). This patient-oriented evaluation method provides a useful tool for the assessment of vitiligo extent. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  9. [Portuguese-language translation and cross-cultural adaptation of the Fatigue domain of Patient-Reported-Outcomes Measurement Information System (PROMIS)].

    PubMed

    Alves, Flávio Sérgio Marques; Pinto, Rogério de Melo Costa; Mendonça, Tânia Maria Silva; Silva, Carlos Henrique Martins da

    2014-05-01

    The items bank of the Fatigue domain is part of an American system developed for evaluation of results reported by patients, called Patient-Reported-Outcomes Measurement Information System (PROMIS). This study aimed to translate and cross-culturally adapt this item bank for the Brazilian population, as a promising new tool for evaluating health-related quality of life. The items in this bank were translated using rigorous translation and back-translation protocols. The translated version was pre-tested in twenty Brazilians with a brief cognitive and retrospective interview in order to test the items' conceptual, cultural, and semantic equivalences. In the translation and back-translation process, only three of the 82 items had to be reworded due to the culturally inadequate content. In the pretest, only four items needed to be reworded, but without conceptual and semantic alterations. The results showed that the translated version of this item bank is conceptually, culturally, and semantically equivalent to the original version.

  10. Validation of the depression item bank from the Patient-Reported Outcomes Measurement Information System (PROMIS) in a three-month observational study.

    PubMed

    Pilkonis, Paul A; Yu, Lan; Dodds, Nathan E; Johnston, Kelly L; Maihoefer, Catherine C; Lawrence, Suzanne M

    2014-09-01

    The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap initiative devoted to developing better measurement tools for assessing constructs relevant to the clinical investigation and treatment of all diseases-constructs such as pain, fatigue, emotional distress, sleep, physical functioning, and social participation. Following creation of item banks for these constructs, our priority has been to validate them, most often in short-term observational studies. We report here on a three-month prospective observational study with depressed outpatients in the early stages of a new treatment episode (with assessments at intake, one-month follow-up, and three-month follow-up). The protocol was designed to compare the psychometric properties of the PROMIS depression item bank (administered as a computerized adaptive test, CAT) with two legacy self-report instruments: the Center for Epidemiological Studies Depression scale (CESD; Radloff, 1977) and the Patient Health Questionnaire (PHQ-9; Spitzer et al., 1999). PROMIS depression demonstrated strong convergent validity with the CESD and the PHQ-9 (with correlations in a range from .72 to .84 across all time points), as well as responsiveness to change when characterizing symptom severity in a clinical outpatient sample. Identification of patients as "recovered" varied across the measures, with the PHQ-9 being the most conservative. The use of calibrations based on models from item response theory (IRT) provides advantages for PROMIS depression both psychometrically (creating the possibility of adaptive testing, providing a broader effective range of measurement, and generating greater precision) and practically (these psychometric advantages can be achieved with fewer items-a median of 4 items administered by CAT-resulting in less patient burden). Copyright © 2014 Elsevier Ltd. All rights reserved.

  11. Minimally important differences were estimated for six Patient-Reported Outcomes Measurement Information System-Cancer scales in advanced-stage cancer patients.

    PubMed

    Yost, Kathleen J; Eton, David T; Garcia, Sofia F; Cella, David

    2011-05-01

    We combined anchor- and distribution-based methods to establish minimally important differences (MIDs) for six Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer scales in advanced-stage cancer patients. Participants completed 6 PROMIS-Cancer scales and 23 anchor measures at an initial (n=101) assessment and a follow-up (n=88) assessment 6-12 weeks later. Three a priori criteria were used to identify usable cross-sectional and longitudinal anchor-based MID estimates. The mean standard error of measurement was also computed for each scale. The focus of the analysis was on item response theory-based MIDs estimated on a T-score scale. Raw score MIDs were estimated for comparison purposes. Many cross-sectional (64%) and longitudinal (73%) T-score anchor-based MID estimates were excluded because they did not meet a priori criteria. The following are the recommended T-score MID ranges: 17-item Fatigue (2.5-4.5), 7-item Fatigue (3.0-5.0), 10-item Pain Interference (4.0-6.0), 10-item Physical Functioning (4.0-6.0), 9-item Emotional Distress-Anxiety (3.0-4.5), and 10-item Emotional Distress-Depression (3.0-4.5). Effect sizes corresponding to these MIDs averaged between 0.40 and 0.63. This study is the first to address MIDs for PROMIS measures. Studies are currently being conducted to confirm these MIDs in other patient populations and to determine whether these MIDs vary by patients' level of functioning. Copyright © 2011 Elsevier Inc. All rights reserved.

  12. Tracking patient-reported outcomes in spinal disorders

    PubMed Central

    Nayak, Nikhil R.; Coats, John Mitchell; Abdullah, Kalil G.; Stein, Sherman C.; Malhotra, Neil R.

    2015-01-01

    Background: Patient-reported outcome measures (PROMs) quantify health status from the patient's point of view. While the number of published outcomes studies grows each year, so too has the number of instruments being reported, leading to confusion on which instruments are appropriate to use for various spinal conditions. Methods: A broad search was conducted to identify commonly used PROMs in patients undergoing spinal surgery. We searched PubMed for combinations of terms related to anatomic location and a measure of patient-reported outcome in the title or text. We supplemented the search using the “related articles” feature of PubMed and by manually searching the bibliographies of selected articles. Results: Major categories of PROMs in spine surgery include health-related quality-of-life, pain, and disease-specific disability, for which several different instrument options were identified and detailed. The minimal clinically important difference varies between instruments and differentiates statistical significance from clinical significance. In addition, the accurate estimation of costs has become a challenging but intrinsically linked variable to outcomes as increased attention is paid to the relative value of surgical interventions. Conclusion: While a number of PROMs are available for tracking outcomes in spine surgery, only a handful appear to be widely used. At least one instrument from each category should be measured pre- and post-operatively to quantify treatment effect. In addition, while the primary goal is to select the most appropriate instruments for the patient's condition, one should keep in mind sustainability of efforts with regard to patient and administrative burden. PMID:26605111

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

    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.

  14. Patient Acceptable Symptom State in Knee Osteoarthritis Patients Succeeds Across Different Patient-reported Outcome Measures Assessing Physical Function, But Fails Across Other Dimensions and Rheumatic Diseases.

    PubMed

    Mahler, Elien A M; Boers, Nadine; Bijlsma, Johannes W J; van den Hoogen, Frank H J; den Broeder, Alfons A; van den Ende, Cornelia H M

    2017-08-15

    The aims of this study are (1) to establish the Patient Acceptable Symptom State (PASS) cutoff values of different patient-reported outcome measures (PROM) assessing physical function in patients with knee osteoarthritis (OA), and (2) to assess the influence of sex, age, duration of symptoms, and presence of depressive feelings on being in PASS. Patients fulfilling the clinical American College of Rheumatology knee OA criteria received standardized nonsurgical treatment and completed different questionnaires at baseline and 3 months assessing physical function: Knee Injury and Osteoarthritis Outcome Score, Lequesne Algofunctional Index, Lower Extremity Functional Scale, numerical rating scale, and the physical function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index. PASS values were defined as the 75th percentile of the score of questionnaires for those patients who consider their state acceptable. Of the 161 included patients, 62% were women with a mean age of 59 years (SD 9) and body mass index of 30 kg/m(2) (SD 5). Standardized PASS values (95% CI) for different questionnaires for physical function varied between 48 (44-54) and 54 (50-56). Female patients and patients feeling depressed were found to have a lower probability to be in PASS for physical function, with OR (95% CI) varying from 0.45 (0.23-0.91) to 0.50 (0.26-0.97) and from 0.27 (0.14-0.55) to 0.38 (0.19-0.77), respectively. PASS cutoff values for physical function are robust across different PROM in patients with knee OA. Our results indicate that PASS values are not consistent across dimensions and rheumatic diseases, and that the use of a generic PASS value for patients with OA or even patients with other rheumatic diseases might not be justifiable.

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

    PubMed

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

    2015-10-01

    The 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). In 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. For 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. In 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.

  16. 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.

  17. The feasibility and acceptability of using the Mother-Generated Index (MGI) as a Patient Reported Outcome Measure in a randomised controlled trial of maternity care.

    PubMed

    Symon, Andrew; Downe, Soo; Finlayson, Kenneth William; Knapp, Rebecca; Diggle, Peter

    2015-11-18

    Using patient-reported outcome measures (PROMs) to assess Quality of Life (QoL) is well established, but commonly-used PROM item-sets do not necessarily capture what all respondents consider important. Measuring complex constructs is particularly difficult in randomised controlled trials (RCTs). The Mother-Generated Index (MGI) is a validated antenatal and postnatal QoL instrument in which the variables and scores are completely respondent-driven. This paper reports on the feasibility and acceptability of the MGI in an RCT, and compares the resulting variables and QoL scores with more commonly used instruments. The single-page MGI was included at the end of a ten page questionnaire pack and posted to the RCT participants at baseline (28-32 weeks' gestation) and follow-up (six weeks postnatal). Feasibility and acceptability were assessed by ease of administration, data entry and completion rates. Variables cited by women were analysed thematically. MGI QoL scores were compared with outcomes from the EQ-5D-3 L; Edinburgh Postnatal Depression Scale; Satisfaction With Life Scale; and State Trait Anxiety Inventory. Six hundred and seventy eight pregnant women returned the pack at baseline; 668 completed the MGI (98.5%); 383/400 returns at follow up included a completed MGI (95.7%). Quantitative data were scanned into SPSS using a standard data scanning system, and were largely error-free; qualitative data were entered manually. The variables recorded by participants on the MGI forms incorporated many of those in the comparison instruments, and other outcomes commonly used in intrapartum trials, but they also revealed a wider range of issues affecting their quality of life. These included financial and work-related worries; moving house; and concerns over family illness and pets. The MGI scores demonstrated low-to-moderate correlation with other tools (all r values p < .01). Without face-to-face explanation and at the end of a long questionnaire, the MGI was feasible

  18. Patients' Preference of the Timed Up and Go Test or Patient-Reported Outcome Measures Before and After Surgery for Lumbar Degenerative Disk Disease.

    PubMed

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

    2017-03-01

    The Timed Up and Go (TUG) test, as a measure of objective functional impairment in lumbar degenerative disk disease (DDD), complements patient-reported outcome measures (PROMs) of subjective functional impairment. Prospective 2-center study on consecutive patients scheduled for surgical treatment for lumbar DDD who underwent an objective (TUG test) and subjective (PROMs) functional assessment before and 1 and 3 days after surgery. PROMs included the visual analog scale (VAS), Roland-Morris Disability Index (RMDI), Oswestry Disability Index (ODI), Euro-Qol (EQ-5D), and Short Form 12 (SF-12) questionnaires. On completion of each assessment, patients were asked whether they would prefer performing the TUG test or completing the PROMs questionnaires. A total of 109 of 125 patients (87.2%) completed the assessments. Preoperatively, patients were 2.18 times as likely to prefer the TUG test to the PROMs (odds ratio [OR], 2.18; 95% confidence interval [CI], 1.27-3.75). On postoperative days 1 and 3, patients were 5.79 (OR, 5.79; 95% CI, 3.23-10.37) and 6.33 times as likely to prefer the TUG test to the PROMs, respectively (OR, 6.33; 95% CI, 3.51-11.41). There were no statistical differences in baseline characteristics, TUG t scores, VAS, RMDI, ODI, SF-12, and EQ-5D index between patients preferring either the TUG test or the PROMs questionnaires. The TUG test is preferred over a battery of PROMs by 60%-70% of patients with lumbar DDD not only in the preoperative, but also in the postoperative, setting. High functional disability does not result in avoidance of the TUG test, and repeated assessments lead to higher preference. Copyright © 2016 Elsevier Inc. All rights reserved.

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

    PubMed

    Fischer, H Felix; Rose, Matthias

    2016-10-19

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

  20. Analysis of differential item functioning in the depression item bank from the Patient Reported Outcome Measurement Information System (PROMIS): An item response theory approach

    PubMed Central

    Teresi, Jeanne A.; Ocepek-Welikson, Katja; Kleinman, Marjorie; Eimicke, Joseph P.; Crane, Paul K.; Jones, Richard N.; Lai, Jin-shei; Choi, Seung W.; Hays, Ron D.; Reeve, Bryce B.; Reise, Steven P.; Pilkonis, Paul A.; Cella, David

    2009-01-01

    The aims of this paper are to present findings related to differential item functioning (DIF) in the Patient Reported Outcome Measurement Information System (PROMIS) depression item bank, and to discuss potential threats to the validity of results from studies of DIF. The 32 depression items studied were modified from several widely used instruments. DIF analyses of gender, age and education were performed using a sample of 735 individuals recruited by a survey polling firm. DIF hypotheses were generated by asking content experts to indicate whether or not they expected DIF to be present, and the direction of the DIF with respect to the studied comparison groups. Primary analyses were conducted using the graded item response model (for polytomous, ordered response category data) with likelihood ratio tests of DIF, accompanied by magnitude measures. Sensitivity analyses were performed using other item response models and approaches to DIF detection. Despite some caveats, the items that are recommended for exclusion or for separate calibration were “I felt like crying” and “I had trouble enjoying things that I used to enjoy.” The item, “I felt I had no energy,” was also flagged as evidencing DIF, and recommended for additional review. On the one hand, false DIF detection (Type 1 error) was controlled to the extent possible by ensuring model fit and purification. On the other hand, power for DIF detection might have been compromised by several factors, including sparse data and small sample sizes. Nonetheless, practical and not just statistical significance should be considered. In this case the overall magnitude and impact of DIF was small for the groups studied, although impact was relatively large for some individuals. PMID:20336180

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

    PubMed

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

    2012-11-26

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

  2. Integrating the Use of Patient-Reported Outcomes for Both Clinical Practice and Performance Measurement: Views of Experts from 3 Countries

    PubMed Central

    Van Der Wees, Philip J; Nijhuis-Van Der Sanden, Maria WG; Ayanian, John Z; Black, Nick; Westert, Gert P; Schneider, Eric C

    2014-01-01

    Context Patient-reported outcomes (PROs) can play an important role in patient-centered health care by focusing on the patient's health goals guiding therapeutic decisions. When aggregated, PROs also can be used for other purposes, including comparative effectiveness research, practice improvement, assessment of the performance of clinicians and organizations, and as a metric for value-based payments. The feasibility of integrating the use of PROs for these various purposes on a wide scale has not yet been demonstrated. Our study was conducted to inform policymakers of prudent next steps for implementing PROs in clinical practice and performance measurement programs in order to maximize their impact on the quality of health care. Methods We conducted a qualitative study, interviewing 58 experts and leaders from 37 organizations (response rate: 88%) in the United States, England, and the Netherlands. Respondents included clinical practitioners (n = 30), measure developers (n = 11), and leaders of performance measurement programs (n = 17). We used a qualitative content analysis to assess current strategies for applying PROs in clinical practice and performance measurement and to identify barriers to and facilitators of further implementation. Findings The use of PROs in clinical practice and for performance measurement has developed both separately and in parallel. Experts across the stakeholder spectrum support the collection of PRO data in an integrated manner that would enable using the data for these distinct purposes. We identified 2 main concerns about the feasibility for integrated use of PRO data: the complexity of establishing routine data collection and the tension among stakeholders when using PRO data for different purposes. These contrasting stakeholder views suggested varying interests among clinicians, measure developers, and purchasers of care. Conclusions Data collection approaches that support the use of PROs in health care are underdeveloped, need

  3. The impact of symptomatic knee osteoarthritis on overall gait pattern deviations and its association with performance-based measures and patient-reported outcomes.

    PubMed

    Naili, Josefine E; Esbjörnsson, Anna-Clara; Iversen, Maura D; Schwartz, Michael H; Hedström, Margareta; Häger, Charlotte K; Broström, Eva W

    2017-06-01

    Limited knowledge exists regarding the impact of symptomatic knee osteoarthritis (OA) on the overall gait pattern; and whether gait deviations are associated with performance-based measures (PBMs) and patient-reported outcomes (PROs). This cross-sectional study evaluated overall gait patterns in patients with knee OA using the Gait Deviation Index for kinematics (GDI) and kinetics (GDI-kinetic), and explored associations between gait deviations, PBMs, and PROs. Forty patients with knee OA and 25 age and gender-matched controls underwent three-dimensional gait analysis. Participants performed the Timed Up and Go (TUG), Five Times Sit-to-Stand (5STS), and Single Limb Mini Squat (SLMS) tests and completed a disease-specific PRO. Associations between gait deviations, PBMs, and PROs were assessed by Pearson's correlation and multiple linear regression. Patients with OA demonstrated significantly lower GDI and GDI-kinetic scores of the OA and contralateral limbs compared to controls; with GDI-kinetic scores on the contralateral limb more impacted than the OA limb. On the contralateral limb, GDI-kinetic score significantly correlated with TUG (r=-0.42) and 5STS (r=-0.33), while on the OA limb with TUG (r=-0.68), 5STS (r=-0.38), SLMS (r=-0.38), activities of daily living (r=0.35) and Knee-related Quality of Life (r=0.35). No significant associations existed between kinematic GDI scores, PBMs and PROs. The overall gait pattern, as represented by GDI and GDI-kinetic scores, in patients with symptomatic knee OA is affected both on the painful OA limb and the contralateral limb. The GDI and GDI-kinetic scores provide different information regarding function that is not revealed by PBMs or PROs. Copyright © 2017 Elsevier B.V. All rights reserved.

  4. Patient-Reported Outcomes Measurement Information System Physical Function Item Bank, Version 1.0: Physical Function Assessment for Athletic Patient Populations.

    PubMed

    Madsen, Leif P; Evans, Todd A; Snyder, Kelli R; Docherty, Carrie L

    2016-09-01

    The Patient-Reported Outcomes Measurement Information System (PROMIS) item banks have been validated for general populations, but their application to high-functioning patient populations remains speculative. To examine the measurement properties of the PROMIS physical function item bank, version 1.0, when applied to individuals representing high levels of physical ability. Cross-sectional study. National Collegiate Athletic Association Division I and III collegiate athletic training rooms and intramural events. A heterogeneous sample of 215 adults from Division I or Division III collegiate or recreational sports volunteered for this study. Participants were divided into 4 groups depending on sport activity and injury status: healthy collegiate (HC; 33 men, 37 women; age = 19.7 ± 1.1 years), injured and currently active in sport (IP; 21 men, 29 women; age = 19.9 ± 1.2 years), injured and currently not active in sport (INP; 12 men, 18 women; age = 19.7 ± 1.3 years), and healthy recreational (HR; 47 men, 18 women; age = 20.1 ± 1.4 years). Participants completed 2 assessments: (1) an injury-history questionnaire and (2) the PROMIS physical function item bank, version 1.0, in computer-adaptive form. Mean PROMIS physical function scores were determined for each group. The PROMIS physical function score for the HC group (61.7 ± 6.0) was higher than for the IP (54.9 ± 7.5) and INP (44.1 ± 8.2) groups (P < .001). The IP group had a higher score than the INP group (P < .001). Mean PROMIS scores were not different between the HC and HR participants (mean difference = 1.9, P = .10). The computer-adaptive PROMIS physical function item bank, version 1.0, accurately distinguished injury status in elite-level athletes on a physical function latent trait continuum. Although it was unable to distinguish HC athletes from HR athletes, exposing a possible ceiling effect, it offers potential for use as an outcome instrument for athletic trainers and other sports medicine

  5. Personal factors in systemic sclerosis and their coverage by patient-reported outcome measures. A multicentre European qualitative study and literature review.

    PubMed

    Mattsson, M; Boström, C; Mihai, C; Stöcker, J; Geyh, S; Stummvoll, G; Gard, G; Möller, B; Hesselstrand, R; Sandqvist, G; Draghicescu, O; Gherghe, A M; Voicu, M; Distler, O; Smolen, J S; Stamm, T A

    2015-08-01

    Systemic sclerosis (SSc) is an autoimmune disease where thickening of the skin can lead to reduced body function and limitations in activities. Severe forms can also affect and seriously damage inner organs. Patient-centred rehabilitation emphasises considerations of patients' background, experience and behavior which highlights the need to know if patient-reported outcome measures (PROMs) include such personal factors. To identify and describe personal factors in the experiences of functioning and health of persons with SSc and to examine if and to what extent PROMs in SSc research cover these factors. Data from a qualitative study with focus group interviews were analysed. PROMs in SSc research were identified in a literature review between 2008-2013. Participants were recruited from outpatient clinics at rheumatology department. Sixty-three patients with SSc from four European countries participated. Data from interviews were analysed using a structure of personal factors developed by Geyh et al. Identified PROMs were analysed and linked to main concepts, related to the personal factors, found in the interview data. Nineteen main concepts were related to the area "patterns of experience and behaviour" in the personal factor structure, 16 to "thoughts and beliefs", nine to "feelings", one to "motives" and one to "personal history and biography", respectively. Among the 35 PROMs identified, 15 did not cover any of the identified concepts. Concepts within the area "feelings" were mostly covered by the PROMs. Five of the PROMs covered "patterns of experience and behaviour", while "motives" and "personal history and biography" were not covered at all. Four of the identified PROMs covered concepts within the areas "feelings", "thoughts and beliefs" and "patterns of experience and behaviour" in the same instrument. The Illness Cognition Questionnaire and Illness Behaviour Questionnaire were such PROMs. Patterns of experience and behaviour had the highest number of

  6. A systematic review of the clinical evidence to guide treatment recommendations in breast reconstruction based on patient- reported outcome measures and health-related quality of life.

    PubMed

    Winters, Zoë Ellen; Benson, John R; Pusic, Andrea L

    2010-12-01

    ) and II (n = 11) evidence. While these studies benefited from more robust design, the majority used generic instruments such as 36-item short form (SF-36), which may not be sufficiently sensitive to measure changes consequent to breast reconstruction (ie, effect on body image or psychosocial well-being). Furthermore, these studies were generally underpowered to detect meaningful clinical difference or to permit subgroup analyses. Further limitations included reliance on single center design that may negatively impact generalizability and deficiencies in reporting the number and types of surgical complications, which potentially has an effect on HRQoL outcomes. This systematic review reveals tendency for sound scientific methodology in HRQoL to be undermined by poorly designed and underpowered studies. In the current healthcare environment, patients and providers increasingly seek meaningful data to guide clinical decisions; policy makers are similarly in need of a rigorous patient-centered, comparative effectiveness data to inform national level decision-making. In light of this and the limitations of the existing published data, there is a pressing need for further Level I and II evidence in the form of randomized controlled trials as well as well-designed, multicenter prospective longitudinal studies in breast reconstruction. Such studies should incorporate sensitive and condition-specific patient-report outcome measures, provide adequate sample sizes, and respect established guidelines for rigorous HRQoL methodology.

  7. Feasibility and diagnostic accuracy of the Patient-Reported Outcomes Measurement Information System (PROMIS) item banks for routine surveillance of sleep and fatigue problems in ambulatory cancer care.

    PubMed

    Leung, Yvonne W; Brown, Catherine; Cosio, Andrea Perez; Dobriyal, Aditi; Malik, Noor; Pat, Vivien; Irwin, Margaret; Tomasini, Pascale; Liu, Geoffrey; Howell, Doris

    2016-09-15

    Routine screening for problematic symptoms is emerging as a best practice in cancer systems globally. The objective of this observational study was to assess the feasibility and diagnostic accuracy of Patient-Reported Outcomes Measurement Information System (PROMIS) computerized adaptive testing (CAT) for fatigue and sleep-disturbance items compared with legacy measures in routine ambulatory cancer care. Patients who attended outpatient clinics at the Princess Margaret Cancer Center completed PROMIS CAT item banks and legacy measures (the Functional Assessment of Chronic Illness Therapy [FACIT]-Fatigue scale and the Insomnia Severity Index [ISI]) using tablet computers during clinic visits. The completion rates, patient acceptability, and diagnostic accuracy of PROMIS CAT were evaluated against legacy measures using receiver operating characteristic (ROC) curve analysis. Participants consisted of 336 patients (mean age ± standard deviation, 57.4 ± 15.7 years; 55% females; 75% Caucasian). Over 98% of patients did not find symptom screening was burdensome, although only 65% were willing to complete the survey at every visit. PROMIS CAT scores were significantly correlated with both FACIT-Fatigue scores (r = -0.83) and ISI scores (r = -0.57; p < 0.0001 for all). Areas under the curve (AUC) by ROC analysis for fatigue were 0.946 using the FACIT-Fatigue cutoff ≤30, 0.910 for sleep disturbance, and 0.922 for sleep impairment using the ISI cutoff ≥15. The recommended T-score cut-off for PROMIS CAT Fatigue was 57, Sleep Disturbance was 57, and Sleep Impairment was 57. The current results support the feasibility and accuracy of PROMIS CAT and its potential for use in routine ambulatory cancer care. Future research will assess feedback of these data to clinicians and evaluate effects on earlier identification of and intervention for these problems. Cancer 2016. © 2016 American Cancer Society. Cancer 2016;122:2906-2917. © 2016 American Cancer

  8. Responsiveness and Minimally Important Differences for 4 Patient-Reported Outcomes Measurement Information System Short Forms: Physical Function, Pain Interference, Depression, and Anxiety in Knee Osteoarthritis.

    PubMed

    Lee, Augustine C; Driban, Jeffrey B; Price, Lori Lyn; Harvey, William F; Rodday, Angie Mae; Wang, Chenchen

    2017-09-01

    Patient-Reported Outcomes Measurement Information System (PROMIS) instruments can provide valid, interpretable measures of health status among adults with osteoarthritis (OA). However, their ability to detect meaningful change over time is unknown. We evaluated the responsiveness and minimally important differences (MIDs) for 4 PROMIS Short Forms: Physical Function, Pain Interference, Depression, and Anxiety. We analyzed adults with symptomatic knee OA from our randomized trial comparing Tai Chi and physical therapy. Using baseline and 12-week scores, responsiveness was evaluated according to consensus standards by testing 6 a priori hypotheses of the correlations between PROMIS and legacy change scores. Responsiveness was considered high if ≥5 hypotheses were confirmed, and moderate if 3 or 4 were confirmed. MIDs were evaluated according to prospective change for people achieving previously-established MID on legacy comparators. The lowest and highest MIDs meeting a priori quality criteria formed a MID range for each PROMIS Short Form. Among 165 predominantly female (70%) and white (57%) participants, mean age was 61 years and body mass index was 33. PROMIS Physical Function had 5 confirmed hypotheses and Pain Interference, Depression, and Anxiety had 3 or 4. MID ranges were: Depression = 3.0 to 3.1; Anxiety = 2.3 to 3.4; Physical Function = 1.9 to 2.2; and Pain Interference = 2.35 to 2.4. PROMIS Physical Function has high responsiveness, and Depression, Anxiety, and Pain Interference have moderate responsiveness among adults with knee OA. We established the first MIDs for PROMIS in this population, and provided an important standard of reference to better apply or interpret PROMIS in future trials or clinical practice. This study examined whether PROMIS Short Form instruments (Physical Function, Pain Interference, Depression, and Anxiety) were able to detect change over time among adults with knee OA, and provided minimally important change estimates

  9. Patient reported outcomes in hip arthroplasty registries.

    PubMed

    Paulsen, Aksel

    2014-05-01

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

  10. Patient-reported outcomes in Huntington's disease: Quality of life in neurological disorders (Neuro-QoL) and Huntington's disease health-related quality of life (HDQLIFE) physical function measures.

    PubMed

    Carlozzi, Noelle E; Ready, Rebecca E; Frank, Samuel; Cella, David; Hahn, Elizabeth A; Goodnight, Siera M; Schilling, Stephen G; Boileau, Nicholas R; Dayalu, Praveen

    2017-07-01

    There is a need for patient-reported outcome measures that capture the impact that motor impairments have on health-related quality of life in individuals with Huntington's disease. The objectives of this study were to establish the reliability and validity of new physical functioning patient-reported outcome measures in Huntington's disease. A total of 510 individuals with Huntington's disease completed 2 Quality of Life in Neurological Disorders (Lower Extremity Function and Upper Extremity Function) and 3 Huntington's Disease Health-Related Quality of Life (Chorea, Speech Difficulties, and Swallowing Difficulties) measures. Clinician-rated and generic self-report measures were also administered. Reliabilities for the new patient reported physical functioning measures were excellent (all Cronbach's α > .92). Convergent, discriminant validity and known group validity was supported. The results provide psychometric support for new patient-reported physical functioning measures and the fact that these measures can be used as clinically meaningful endpoints in Huntington's disease research and clinical practice. © 2017 International Parkinson and Movement Disorder Society. © 2017 International Parkinson and Movement Disorder Society.

  11. Correlation of the National Institutes of Health patient reported outcomes measurement information system scales and standard pain and functional outcomes in spine augmentation.

    PubMed

    Shahgholi, L; Yost, K J; Kallmes, D F

    2012-12-01

    The recently developed National Institutes of Health PROMIS initiative provides reliable and valid measures across many health domains. We correlated changes in pain-related PROMIS measures and changes in both an NRS and the RMDI in patients undergoing spine augmentation. Fifty patients, composed of 26 women (40-91 years of age; mean, 72.6 years) and 24 men (42-78 years of age, mean, 67.5 years) were enrolled in the study. They were asked at initial presentation and at 30 days to rate the intensity of their pain in the past 24 hours by using a 0-10 pain NRS as well at the 23-item RMDI. Study subjects also completed 3 different PROMIS short forms, including physical function, pain behavior, and pain interference. The Spearman correlation was used to assess the correlation between the scales. The RCI × 1.96 was calculated for each measurement tool as an indicator of change. All instruments were responsive to detection of change during 1 month (all, P < .0001). Correlations between changes in physical function, pain interference, and pain behavior PROMIS scores and changes in RMDI scores were 0.37, 0.44, and 0.42, respectively. Direction of changes (declines versus improvements) in RMDI and other scales were the same in approximately 60% of patients. All measures evaluated had adequate and comparable psychometric properties. The choice of which measure to use depends on the clinical intent of the intervention.

  12. Longitudinal deteriorations in patient reported outcomes in patients with COPD.

    PubMed

    Oga, Toru; Nishimura, Koichi; Tsukino, Mitsuhiro; Sato, Susumu; Hajiro, Takashi; Mishima, Michiaki

    2007-01-01

    Goals of effective management of patients with chronic obstructive pulmonary disease (COPD) include relieving their symptoms and improving their health status. We examined how such patient reported outcomes would change longitudinally in comparison to physiological outcomes in COPD. One hundred thirty-seven male outpatients with stable COPD were recruited for the study. The subjects health status was evaluated using the St. George's Respiratory Questionnaire (SGRQ) and the Chronic Respiratory Disease Questionnaire (CRQ). Their dyspnoea using the modified Medical Research Council (MRC) scale and their psychological status using the Hospital Anxiety and Depression Scale (HADS) were assessed upon entry and every 6 months thereafter over a 5-year period. Pulmonary function and exercise capacity as evaluated by peak oxygen uptake (VO2) on progressive cycle ergometry were also followed over the same time. Using mixed effects models to estimate the slopes for the changes, scores on the SGRQ, the CRQ, the MRC and the HADS worsened in a statistically significant manner over time. However, changes only weakly correlated with changes in forced expiratory volume in 1s (FEV(1)) and peak (VO2). We demonstrated that although changes in pulmonary function and exercise capacity are well known in patients with COPD, patient reported outcomes such as health status, dyspnoea and psychological status also deteriorated significantly over time. In addition, deteriorations in patient reported outcomes only weakly correlated to changes in physiological indices. To capture the overall deterioration of COPD from the subjective viewpoints of the patients, patient reported outcomes should be followed separately from physiological outcomes.

  13. Initial severity of motor and non-motor disabilities in patients with facial palsy: an assessment using patient-reported outcome measures.

    PubMed

    Volk, Gerd Fabian; Granitzka, Thordis; Kreysa, Helene; Klingner, Carsten M; Guntinas-Lichius, Orlando

    2017-01-01

    Patients with facial palsy (FP) not only suffer from their facial movement disorder, but also from social and psychological disabilities. These can be assessed by patient-reported outcome measures (PROMs) like the quality-of-life Short-Form 36 Item Questionnaire (SF36) or FP-specific instruments like the Facial Clinimetric Evaluation Scale (FaCE) or the Facial Disability Index (FDI). Not much is known about factors influencing PROMs in patients with FP. We identified predictors for baseline SF36, FaCE, and FDI scoring in 256 patients with unilateral peripheral FP using univariate correlation and multivariate linear regression analyses. Mean age was 52 ± 18 years. 153 patients (60 %) were female. 90 patients (31 %) and 176 patients (69 %) were first seen <90 or >90 days after onset, respectively, i.e., with acute or chronic FP. House-Brackmann grading was 3.9 ± 1.4. FaCE subscores varied from 41 ± 28 to 71 ± 26, FDI scores from 65 ± 20 to 70 ± 22, and SF36 domains from 52 ± 20 to 80 ± 24. Older age, female gender, higher House-Brackmann grading, and initial assessment >90 days after onset were independent predictors for lower FaCE subscores and partly for lower FDI subscores (all p < 0.05). Older age and female gender were best predictors for lower results in SF36 domains. Comorbidity was associated with lower SF General health perception and lower SF36 Emotional role (all p < 0.05). Specific PROMs reveal that older and female patients and patients with chronic FP suffer particularly from motor and non-motor disabilities related to FP. Comorbidity unrelated to the FP could additionally impact the quality of life of patients with FP.

  14. Patient-reported outcomes measured by BREAST-Q after implant-based breast reconstruction: A cross-sectional controlled study in Brazilian patients.

    PubMed

    Aguiar, Isabella de Carvalho; Veiga, Daniela Francescato; Marques, Thaline Figueiredo; Novo, Neil Ferreira; Sabino Neto, Miguel; Ferreira, Lydia Masako

    2017-02-01

    The purpose of this study was to assess patient-reported outcomes of breast reconstruction with implants, using the BREAST-Q, in the late postoperative period. A total of 114 women previously operated due to breast cancer, in the late postoperative period (range 6-24 months) were enrolled in this cross-sectional study, and were allocated to either the mastectomy group (MG, n = 57) or reconstruction group (RG, n = 57). Patients in MG and RG, respectively, completed the Brazilian versions of Mastectomy and Reconstruction Modules of the BREAST-Q. The mean age of patients was 46.6 and 44.3 years in MG and RG, respectively. All patients underwent chemotherapy and 6% and 11% of patients underwent radiotherapy in MG and RG, respectively. Patients in the RG reported higher satisfaction with surgical outcome (P < 0.0001). However, no significant between-group differences were found in physical and sexual well-being, or satisfaction with the plastic surgeon, medical team, and office staff. Breast reconstruction with implants increased patient satisfaction with the surgical outcome, but did not influence patients' physical and sexual well-being or their satisfaction with the treatment received. Copyright © 2016 Elsevier Ltd. All rights reserved.

  15. Effect of Secukinumab on Patient-Reported Outcomes in Patients With Active Ankylosing Spondylitis: A Phase III Randomized Trial (MEASURE 1).

    PubMed

    Deodhar, Atul A; Dougados, Maxime; Baeten, Dominique L; Cheng-Chung Wei, James; Geusens, Piet; Readie, Aimee; Richards, Hanno B; Martin, Ruvie; Porter, Brian

    2016-12-01

    To evaluate the effect of secukinumab (interleukin-17A inhibitor) on patient-reported outcomes in patients with active ankylosing spondylitis (AS). In this phase III study, 371 patients were randomized (1:1:1) to receive intravenous (IV) secukinumab 10 mg/kg at baseline and weeks 2 and 4 followed by subcutaneous (SC) secukinumab 150 mg every 4 weeks (IV→150 mg group), or SC secukinumab 75 mg every 4 weeks (IV→75 mg group), or placebo. Patient-reported outcomes included the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), BASDAI criteria for 50% improvement (BASDAI 50), Short Form 36 (SF-36) physical component summary (PCS) score and mental component summary (MCS) score, Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire, Bath Ankylosing Spondylitis Functional Index (BASFI), EuroQol 5-domain (EQ-5D) questionnaire, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and Work Productivity and Activity Impairment-General Health questionnaire (WPAI-GH). At week 16, secukinumab IV→150 mg or IV→75 mg was associated with statistically and clinically significant improvements from baseline versus placebo in the BASDAI (-2.3 for both regimens versus -0.6; P < 0.0001 and P < 0.001, respectively), SF-36 PCS (5.6 for both regimens versus 1.0; P < 0.0001 and P < 0.001, respectively), and ASQoL (-3.6 for both regimens versus -1.0; P < 0.0001 and P < 0.001, respectively). Clinically significant improvements in the SF-36 MCS, BASFI, EQ-5D, and BASDAI 50 were observed with both secukinumab groups versus placebo at week 16; improvements were also observed in the FACIT-F and WPAI-GH. All improvements were sustained through week 52. Our findings indicate that secukinumab provides significant and sustained improvements in patient-reported disease activity and health-related quality of life, and reduces functional impairment, fatigue, and impact of disease on work productivity in patients with active AS. © 2016 The

  16. Patient-Reported Outcomes in Systemic Lupus Erythematosus

    PubMed Central

    Ramsey-Goldman, Rosalind

    2016-01-01

    Successful management of complex conditions such as systemic lupus erythematosus, SLE, and comorbid conditions benefit significantly from patient-reported outcomes (PRO) instruments that validly and precisely measure relevant aspects of health status (e.g., symptoms) and health related quality of life. Measuring health related quality of life and other aspects of health status (e.g., symptoms, functioning) with PROs provides SLE patients with an opportunity to participate in their treatment and to facilitate better communication with the multi-disciplinary team of health professionals involved in their care. Health outcomes research has produced a number of well-validated instruments that can be used across diseases whereas some have been specifically developed for SLE. The use of either a generic and SLE-specific PRO depends on the particular needs of a variety of clinical applications including population monitoring, treatment decision-making in clinical practice, clinical trials research, and for evaluating and comparing the effect of therapies across conditions, therapies, trials and patients in clinical research studies. PMID:27133488

  17. Equivalence of electronic and paper administration of patient-reported outcome measures: a systematic review and meta-analysis of studies conducted between 2007 and 2013.

    PubMed

    Muehlhausen, Willie; Doll, Helen; Quadri, Nuz; Fordham, Bethany; O'Donohoe, Paul; Dogar, Nijda; Wild, Diane J

    2015-10-07

    To conduct a systematic review and meta-analysis of the equivalence between electronic and paper administration of patient reported outcome measures (PROMs) in studies conducted subsequent to those included in Gwaltney et al's 2008 review. A systematic literature review of PROM equivalence studies conducted between 2007 and 2013 identified 1,997 records from which 72 studies met pre-defined inclusion/exclusion criteria. PRO data from each study were extracted, in terms of both correlation coefficients (ICCs, Spearman and Pearson correlations, Kappa statistics) and mean differences (standardized by the standard deviation, SD, and the response scale range). Pooled estimates of correlation and mean difference were estimated. The modifying effects of mode of administration, year of publication, study design, time interval between administrations, mean age of participants and publication type were examined. Four hundred thirty-five individual correlations were extracted, these correlations being highly variable (I2 = 93.8) but showing generally good equivalence, with ICCs ranging from 0.65 to 0.99 and the pooled correlation coefficient being 0.88 (95% CI 0.87 to 0.88). Standardised mean differences for 307 studies were small and less variable (I2 = 33.5) with a pooled standardised mean difference of 0.037 (95% CI 0.031 to 0.042). Average administration mode/platform-specific correlations from 56 studies (61 estimates) had a pooled estimate of 0.88 (95% CI 0.86 to 0.90) and were still highly variable (I2 = 92.1). Similarly, average platform-specific ICCs from 39 studies (42 estimates) had a pooled estimate of 0.90 (95% CI 0.88 to 0.92) with an I2 of 91.5. After excluding 20 studies with outlying correlation coefficients (≥3SD from the mean), the I2 was 54.4, with the equivalence still high, the overall pooled correlation coefficient being 0.88 (95% CI 0.87 to 0.88). Agreement was found to be greater in more recent studies (p < 0.001), in randomized

  18. Use of Patient-Reported Outcome (PRO) Measures at Group and Patient Levels: Experiences From the Generic Integrated PRO System, WestChronic

    PubMed Central

    Larsen, Louise Pape; Biering, Karin; Johnsen, Soren Paaske; Riiskjær, Erik; Schougaard, Liv Marit

    2014-01-01

    Background Patient-reported outcome (PRO) measures may be used at a group level for research and quality improvement and at the individual patient level to support clinical decision making and ensure efficient use of resources. The challenges involved in implementing PRO measures are mostly the same regardless of aims and diagnostic groups and include logistic feasibility, high response rates, robustness, and ability to adapt to the needs of patient groups and settings. If generic PRO systems can adapt to specific needs, advanced technology can be shared between medical specialties and for different aims. Objective We describe methodological, organizational, and practical experiences with a generic PRO system, WestChronic, which is in use among a range of diagnostic groups and for a range of purposes. Methods The WestChronic system supports PRO data collection, with integration of Web and paper PRO questionnaires (mixed-mode) and automated procedures that enable adherence to implementation-specific schedules for the collection of PRO. For analysis, we divided functionalities into four elements: basic PRO data collection and logistics, PRO-based clinical decision support, PRO-based automated decision algorithms, and other forms of communication. While the first element is ubiquitous, the others are optional and only applicable at a patient level. Methodological and organizational experiences were described according to each element. Results WestChronic has, to date, been implemented in 22 PRO projects within 18 diagnostic groups, including cardiology, neurology, rheumatology, nephrology, orthopedic surgery, gynecology, oncology, and psychiatry. The aims of the individual projects included epidemiological research, quality improvement, hospital evaluation, clinical decision support, efficient use of outpatient clinic resources, and screening for side effects and comorbidity. In total 30,174 patients have been included, and 59,232 PRO assessments have been collected

  19. Patient reported outcomes as endpoints in medical research.

    PubMed

    Fairclough, Diane L

    2004-04-01

    This review covers a number of the many design and analytic issues associated with clinical trials that incorporate patient reported outcomes as primary or secondary endpoints. We use a clinical trial designed to evaluate a new therapy for the prevention of migraines to illustrate how endpoints are defined by the objectives of the study, the methods for handling longitudinal assessments with multiple scales or outcomes, and the methods of analysis in the presence of missing data.

  20. Patient-reported outcomes in idiopathic pulmonary fibrosis research.

    PubMed

    Swigris, Jeffrey J; Fairclough, Diane

    2012-08-01

    Patient-reported outcomes (PROs) include questionnaires or surveys that ask patients for their perceptions about things like symptoms they are experiencing or quality of life. For incurable, morbid, life-shortening conditions like idiopathic pulmonary fibrosis (IPF), PROs are particularly germane: They elucidate for clinicians and researchers what it is like for patients to live with such a disease, and they may detect important treatment effects not captured by other metrics (eg, pulmonary physiology). However, a relative paucity of research on PROs in IPF has left significant knowledge gaps in this area and contributed to the timidity investigators have about using PROs as prominent outcomes in IPF drug trials. Additional research on existing instruments is needed to establish or bolster their basic psychometric properties in IPF. When PROs are used as end points in therapeutic trials, analyzing PRO response data can be challenging, but these challenges can be overcome with a transparent, thoughtful, and sophisticated statistical approach. In this article, we discuss some of the basics of PRO assessment, existing knowledge gaps in IPF-related PRO research, and the potential usefulness of using PROs in IPF trials and conclude by offering specific recommendations for an approach to analyzing repeated-measures PRO data from IPF trials.

  1. Patient-Reported Outcomes Measurement Information System (PROMIS) Domain Names and Definitions Revisions: Further Evaluation of Content Validity in IRT-derived Item Banks

    PubMed Central

    Riley, William T.; Rothrock, Nan; Bruce, Bonnie; Christodolou, Christopher; Cook, Karon; Hahn, Elizabeth A.; Cella, David

    2013-01-01

    Purpose Content validity of patient-reported outcomes (PROs) is evaluated primarily during item development, but subsequent psychometric analyses, particularly for item-response theory (IRT)-derived scales, often result in considerable item pruning and potential loss of content. After selecting items for the PROMIS banks based on psychometric and content considerations, we invited external content expert reviews of the degree to which the initial domain names and definitions represented the calibrated item bank content. Methods A minimum of four content experts reviewed each item bank and recommended a domain name and definition based on item content. Domain names and definitions then were revealed to the experts who rated how well these names and definitions fit the bank content and provided recommendations for definition revisions. Results These reviews indicated that the PROMIS domain names and definitions remained generally representative of bank content following item pruning, but modifications to two domain names and minor to moderate revisions of all domain definitions were needed to optimize fit with the item bank content. Conclusions This reevaluation of domain names and definitions following psychometric item pruning, although not previously documented in the literature, appears to be an important procedure for refining conceptual frameworks and further supporting content validity. PMID:20593306

  2. Validation of the National Institutes of Health Patient-Reported Outcomes Measurement Information System Survey as a Quality-of-Life Instrument for Patients with Malignant Brain Tumors and Their Caregivers.

    PubMed

    Romero, Melissa M; Flood, Lisa Sue; Gasiewicz, Nanci K; Rovin, Richard; Conklin, Samantha

    2015-12-01

    At present there is a lack of well-validated surveys used to measure quality of life in patients with malignant brain tumors and their caregivers. The main objective of this pilot study was to validate the National Institutes of Health Patient-Reported Outcomes Measurement Information System (NIH PROMIS) survey for use as a quality-of-life measure in this population. This article presents the rationale for using the NIH PROMIS instrument as a quality-of-life measure for patients with malignant brain tumors and their caregivers.

  3. New measures to capture end of life concerns in Huntington disease: Meaning and Purpose and Concern with Death and Dying from HDQLIFE (a patient reported outcomes measurement system)

    PubMed Central

    Carlozzi, N.E.; Downing, N.R.; McCormack, M.K.; Schilling, S.G.; Perlmutter, J.S.; Hahn, E. A.; Lai, J.-S.; Frank, S.; Quaid, K.A.; Paulsen, J. S.; Cella, D.; Goodnight, S.M.; Miner, J.A.; Nance, M.A.

    2016-01-01

    Purpose Huntington disease (HD) is an incurable terminal disease. Thus, end of life (EOL) concerns are common in these individuals. A quantitative measure of EOL concerns in HD would enable a better understanding of how these concerns impact health-related quality of life. Therefore, we developed new measures of EOL for use in HD. Methods An EOL item pool of 45 items was field tested in 507 individuals with prodromal or manifest HD. Exploratory and confirmatory factor analyses (EFA and CFA, respectively) were conducted to establish unidimensional item pools. Item response theory (IRT) and differential item functioning analyses were applied to the identified unidimensional item pools to select the final items. Results EFA and CFA supported two separate unidimensional sets of items: Concern with Death and Dying (16 items), and Meaning and Purpose (14 items). IRT and DIF supported the retention of 12 Concern with Death and Dying items and 4 Meaning and Purpose items. IRT data supported the development of both a computer adaptive test (CAT) and a 6-item, static short-form for Concern with Death and Dying. Conclusions The HDQLIFE Concern with Death and Dying CAT and corresponding 6-item short form, and the 4-item calibrated HDQLIFE Meaning and Purpose Scale demonstrate excellent psychometric properties. These new measures have the potential to provide clinically meaningful information about end of life preferences and concerns to clinicians and researchers working with individuals with HD. In addition, these measures may also be relevant and useful for other terminal conditions. PMID:27393121

  4. 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

  5. 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

  6. 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

  7. Research Priorities for Optimal Use of Patient-reported Outcomes in Quality and Outcome Improvement for Total Knee Arthroplasty.

    PubMed

    Franklin, Patricia D

    2017-02-01

    The national Functional and Outcomes Research for Comparative Effectiveness in Total Joint Replacement program routinely collects pre- and postoperative patient-reported outcomes for clinicians to use when making individual patient treatment decisions and monitoring aggregate quality of care and outcomes. When the pre-post gains in pain or function at one site vary from the national norms, the next question is, "how do we improve?" This paper will use the traditional quality management's framework of inputs (patients), processes (clinical care), and outcomes to outline priority research questions to learn how clinicians, hospital managers, and patients can interpret patient-reported outcomes to improve total knee arthroplasty care and outcomes. In summary, research should identify best practices to minimize variation in a patient's health status before surgery, tailor peri-total knee arthroplasty care pathways to match individual patient risks to optimize safe care, and implement patient-reported measures to document optimal outcomes.

  8. Patient-reported outcomes in neurofibromatosis and schwannomatosis clinical trials

    PubMed Central

    Martin, Staci; Merker, Vanessa L.; Gardner, Kathy L.; Hingtgen, Cynthia M.; Tonsgard, James H.; Schorry, Elizabeth K.; Baldwin, Andrea

    2013-01-01

    Objectives: Neurofibromatosis (NF) is a genetic disease with multiple clinical manifestations that can significantly impact quality of life (QOL). Clinical trials should include patient-reported outcomes (PROs) as endpoints to assess treatment effects on various aspects of QOL, but there is no consensus on the selection and use of such measures in NF. This article describes the PRO Working Group of the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) Collaboration, its main goals, methods for identifying appropriate PRO measures for NF clinical trials, and recommendations for assessing pain intensity. Methods: The REiNS PRO group selected core endpoint domains important to assess in NF. The members developed criteria to rate PRO measures, including patient characteristics, psychometric properties, and feasibility, and utilized a systematic process to evaluate PROs for NF clinical trials. Within the subdomain of pain intensity, the group reviewed the Numerical Rating Scale-11 (NRS-11), the Visual Analogue Scale, and the Faces Pain Scale-Revised using this process. Results: Based on the review criteria, each of these pain intensity scales is brief, reliable, valid, and widely used. However, the NRS-11 was given the highest rating for use in NF clinical trials due to recommendations from pain experts and other consensus groups, its extensive use in research, strong psychometric data including sensitivity to change, and excellent feasibility in ages ≥8 years. Conclusions: The systematic review criteria and process are effective for identifying appropriate PRO measures and provide information utilized by the REiNS Collaboration to achieve consensus regarding PROs in NF clinical trials. PMID:24249806

  9. 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

  10. Refining the Pediatric Evaluation of Disability Inventory-Patient-Reported Outcome (PEDI-PRO) item candidates: interpretation of a self-reported outcome measure of functional performance by young people with neurodevelopmental disabilities.

    PubMed

    Kramer, Jessica M; Schwartz, Ariel

    2017-06-05

    This study examined the item interpretability and rating scale use of the Pediatric Evaluation of Disability Inventory-Patient-Reported Outcome (PEDI-PRO) by young people with developmental disabilities. The PEDI-PRO assesses the functional performance of discrete functional tasks in the context of everyday life situations. A two-phase cognitive interview design was implemented with a convenience sample of 37 young people (mean age 19y, SD 2y 5mo; 13 males and 24 females; 68% with intellectual disability) with developmental disabilities. In phase I, 182 item candidates were each reviewed by an average of four young people. In phase II, 103 items were carried forward or revised and each reviewed by an average of seven additional young people. Two raters coded responses for intended item interpretation and performance quality; codes were analysed using descriptive statistics. Qualitative analysis explored young people's self-evaluation process. Items were interpreted as intended by most young people (mean 86%). Young people can use PEDI-PRO response categories appropriately to describe their performance: 94% of positive performance descriptions coincided with a positive response category choice; 73% of negative descriptions coincided with a negative response category choice. Young people interpreted items in a literal manner, and their self-evaluation incorporated the use of supports that facilitate functional performance. The PEDI-PRO's measurement framework appears to support the self-evaluation of functional performance of young people with developmental disabilities. © 2017 Mac Keith Press.

  11. 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.

  12. Using Patient Reported Outcomes in Oncology Clinical Practice.

    PubMed

    Kelleher, Sarah A; Somers, Tamara J; Locklear, Tracie; Crosswell, Alexandra D; Abernethy, Amy P

    2016-10-01

    Patient reported outcomes (PROs) are increasingly being implemented into the care of patients with cancer. The use of a standard set of PROs (e.g., pain) in cancer is becoming established and there is interest in what additional PROs might provide valuable information. The goal of this observational study was to examine how the PROs of self-efficacy for pain and other symptoms assessed at the point of service were associated with pain, symptom severity and distress, and physical and psychosocial functioning in a sample of breast and gastrointestinal patients. We also sought to examine differences in these relationships by cancer type (breast and gastrointestinal) as well as understand differences in self-assessment mode (paper/pencil or electronic tablet). 178 patients with breast (n=65) and gastrointestinal cancer (n = 113) completed the Chronic Pain Self Efficacy Scale, M.D. Anderson Symptom Inventory, and Functional Assessment of Cancer Therapy-General questionnaires. Measures were completed with paper and pencil and electronically using a tablet computer while patients waited for their clinical appointment. Responses from the initial completed questionnaires on both the paper and electronic instruments were analyzed. Patients' self-efficacy scores for pain and other symptoms correlated positively with pain, symptom severity and distress, and physical and psychosocial functioning; patients with lower levels of self-efficacy reported poorer outcomes and functioning overall. The results were independent of cancer type and mode of assessment. No statistically significant differences were found in the PROs when collected by electronic technology versus paper-pencil mode; patients were very satisfied with using the tablet computer to complete the PRO measures. Our results suggest that self-efficacy for pain and symptom management may be a beneficial addition to clinic-based PRO assessment batteries for patients with cancer and other chronic diseases. Existing short

  13. 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

  14. 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

  15. 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

  16. Pre- and postoperative correlation of patient-reported outcome measures with standardized Timed Up and Go (TUG) test results in lumbar degenerative disc disease.

    PubMed

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

    2016-10-01

    The Timed Up and Go (TUG) test is a reliable tool for evaluating objective functional impairment (OFI) in patients with degenerative disc disease before a surgical intervention. The aim of this study is to assess the validity of the TUG test to measure change in function postoperatively. In a prospective two-center study, OFI was assessed by the TUG test in patients scheduled for lumbar spine surgery, as well as 3 days (D3) and 6 weeks (W6) postoperatively. At each time point, the TUG test results were correlated with established subjective measures of pain intensity (visual analogue scale (VAS) for back and leg pain), functional impairment (Oswestry Disability Index (ODI)) and health-related quality of life (HRQoL; Short Form-12 (SF12)). The patient cohort comprised 136 patients with a mean age of 57.7 years; 76 were males, 54 had a microdiscectomy for lumbar disc herniation, 58 a decompression for a lumbar spinal stenosis, 24 had a surgical fusion procedure. The mean OFI t-score was 125.1 before surgery, and as patients improved on the subjective measures in the postoperative interval, the OFI t-score likewise decreased to 118.8 (D3) and 103.4 (W6). The Pearson correlation coefficient (PCC) between the OFI t-score and VAS leg pain was 0.187 preoperatively (p = 0.029) and 0.252 at W6 (p = 0.003). The PCC between OFI t-score and the ODI was 0.324 preoperatively (p < 0.001) and 0.413 at W6 (p < 0.001). The PCC between OFI t-score and physical HRQoL (SF12) was -0.091 preoperatively (p = 0.293) and -0.330 at W6 (p < 0.001). The TUG test is sensitive to change, and reflects the postoperative functional outcome even more exact than preoperatively, as indicated by better correlation coefficients of the OFI t-score with subjective measures of pain intensity, functional impairment and HRQoL.

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

    PubMed

    Gawlicki, Mary C; McKown, Shawn M; Talbert, Matthew J; Brandt, Barbara A

    2014-02-13

    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. 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. 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. 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 large variety of definitions and

  18. 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

  19. Establishing clinical meaning and defining important differences for Patient-Reported Outcomes Measurement Information System (PROMIS(®)) measures in juvenile idiopathic arthritis using standard setting with patients, parents, and providers.

    PubMed

    Morgan, Esi M; Mara, Constance A; Huang, Bin; Barnett, Kimberly; Carle, Adam C; Farrell, Jennifer E; Cook, Karon F

    2017-03-01

    Patient-Reported Outcomes Measurement Information System (PROMIS) measures are used increasingly in clinical care. However, for juvenile idiopathic arthritis (JIA), scores lack a framework for interpretation of clinical severity, and minimally important differences (MID) have not been established, which are necessary to evaluate the importance of change. We identified clinical severity thresholds for pediatric PROMIS measures of mobility, upper extremity function (UE), fatigue, and pain interference working with adolescents with JIA, parents of JIA patients, and clinicians, using a standard setting methodology modified from educational testing. Item parameters were used to develop clinical vignettes across a range of symptom severity. Vignettes were ordered by severity, and panelists identified adjacent vignettes considered to represent upper and lower boundaries separating category cut-points (i.e., from none/mild problems to moderate/severe). To define MIDs, panelists reviewed a full score report for the vignettes and indicated which items would need to change and by how much to represent "just enough improvement to make a difference." For fatigue and UE, cut-points among panels were within 0.5 SD of each other. For mobility and pain interference, cut-scores among panels were more divergent, with parents setting the lowest cut-scores for increasing severity. The size of MIDs varied by stakeholders (parents estimated largest, followed by patients, then clinicians). MIDs also varied by severity classification of the symptom. We estimated clinically relevant severity cut-points and MIDs for PROMIS measures for JIA from the perspectives of multiple stakeholders and found notable differences in perspectives.

  20. The selection of core International Classification of Functioning, Disability, and Health (ICF) categories for patient-reported outcome measurement in spine trauma patients-results of an international consensus process.

    PubMed

    Sadiqi, Said; Lehr, A Mechteld; Post, Marcel W; Jacobs, Wilco C H; Aarabi, Bizhan; Chapman, Jens R; Dunn, Robert N; Dvorak, Marcel F; Fehlings, Michael G; Rajasekaran, S; Vialle, Luiz R; Vaccaro, Alexander R; Oner, F Cumhur

    2016-08-01

    There is no outcome instrument specifically designed and validated for spine trauma patients without complete paralysis, which makes it difficult to compare outcomes of different treatments of the spinal column injury within and between studies. The paper aimed to report on the evidence-based consensus process that resulted in the selection of core International Classification of Functioning, Disability, and Health (ICF) categories, as well as the response scale for use in a universal patient-reported outcome measure for patients with traumatic spinal column injury. The study used a formal decision-making and consensus process. The sample includes patients with a primary diagnosis of traumatic spinal column injury, excluding completely paralyzed and polytrauma patients. The wide array of function and health status of patients with traumatic spinal column injury was explored through the identification of all potentially meaningful ICF categories. A formal decision-making and consensus process integrated evidence from four preparatory studies. Three studies aimed to identify relevant ICF categories from three different perspectives. The research perspective was covered by a systematic literature review identifying outcome measures focusing on the functioning and health of spine trauma patients. The expert perspective was explored through an international web-based survey among spine surgeons from the five AOSpine International world regions. The patient perspective was investigated in an international empirical study. A fourth study investigated various response scales for their potential use in the future universal outcome instrument. This work was supported by AOSpine. AOSpine is a clinical division of the AO Foundation, an independent medically guided non-profit organization. The AOSpine Knowledge Forums are pathology-focused working groups acting on behalf of AOSpine in their domain of scientific expertise. Combining the results of the preparatory studies, the

  1. Convergent Validity of the Patient Reported Outcomes Measurement Information System's (PROMIS) Physical Function Computerized Adaptive Test (PF-CAT) for the Knee and Shoulder Injury Sports Medicine Patient Population

    PubMed Central

    Robins, Richard Judd; Zhang, Yingying; Anderson, Mike B.; Presson, Angela P.; Burks, Robert T.; Greis, Patrick E.

    2015-01-01

    Objectives: The Patient Reported Outcomes Measurement Instrument System (PROMIS) Physical Function Computer Adaptive Test (PF-CAT) has been developed by the National Institutes of Health as a means of providing validated outcomes scores. PF-CAT adapts to patient response by applying different validated questions based on prior responses to generate scores using between 4 to 12 questions, and has been validated in a variety of patient populations to assess physical function. The purpose of our study is to compare patient reported outcomes scores in a sports medicine (shoulder and knee injury) patient population by analyzing convergence validity of PF-CAT to IKDC, SST, ASES, and SANE scores. We also wanted to assess and compare time burden placed on patients in completing these outcomes scores. Methods: All patient visits from April through September 2014 presenting with either knee or shoulder complaints were included from a university-based sports medicine clinic, during which both PF-CAT as well as SANE, SST, and ASES legacy outcomes scores for shoulder injury patients, and SANE and IKDC outcomes scores for knee injury patients were obtained via tablet during the initial part of each visit. A total of 415 shoulder and 450 knee clinical evaluations qualified for inclusion in the study. Spearman correlation was used to evaluate pair-wise agreement among outcomes scores. The total scores from each outcome test and the T-scores from the PF-CAT were used in this correlation analysis. For interpretation, results greater than 0.5-0.69 were considered to have fair correlation, while values greater than 0.7 were considered as having good correlation. Significance was assessed at the 0.05 level. Median and interquartile ranges were used to summarize scores. The minimum score (floor effects) and maximum score (ceiling effects) occurrences were tallied and reported as percentages. A Fishers exact test was used to test for a difference in the number of times floor and ceiling

  2. Post-operative radiographic factors and patient-reported outcome after total hip replacement.

    PubMed

    Wylde, Vikki; Maclean, Angus; Blom, Ashley W

    2012-01-01

    Although total hip replacement (THR) is considered a very successful surgical intervention, a proportion of patients experience persistent pain or disability, and/or dissatisfaction with the outcome of surgery. Our aim was to determine whether post-operative radiographic variables were predictive of patient-reported pain, function and satisfaction after primary THR. At 1-3 years after surgery patients completed the WOMAC Pain scale, WOMAC Function scale and a validated measure of satisfaction with the outcome of surgery. Post-operative radiographs taken prior to discharge were graded for the restoration of offset, restoration of leg length, anteroposterior (AP) alignment of the femoral stem and AP acetabular inclination. Binary logistic regression was used to identify whether radiographic variables were significant predictors of patient-reported outcome scores. Radiographic and patient-reported outcomes data were available for 452 THR patients. No radiographic predictors were found to be significant predictors of patient reported pain, function or satisfaction at 1-3 years after THR. This highlights that patients with continuing problems after THR may benefit from a thorough multidisciplinary assessment to diagnose the underlying cause of the problems.

  3. 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.

  4. Cancer patient-reported outcomes assessment using wireless touch screen tablet computers.

    PubMed

    Stukenborg, G J; Blackhall, L; Harrison, J; Barclay, J S; Dillon, P; Davis, M A; Mallory, M; Read, P

    2014-06-01

    To assess the feasibility of collecting patient-reported outcomes data with wireless touch screen tablet computers in the adult oncology palliative care setting. Patients were provided with tablet computers during scheduled clinic visits and answered online queries about their experience over the past week in the health domains of anxiety, depression, fatigue, pain interference, physical function, instrumental social support, sleep impairment, diarrhea, constipation, nausea, vomiting, anorexia, dyspnea, neuropathy, and spiritual values. Content analysis of patient interviews indicates that wireless touch screen tablet computers are a feasible approach for collecting patient-reported outcome measures by palliative care cancer patients presenting in clinic. Most patients indicated that the questionnaire was easy to answer. However, all but one patient requested some form of assistance, and many reported difficulties attributable to a lack of familiarity with the device, interpretation of certain questions, and wireless connectivity-related issues. This feasibility study demonstrates that tablet computers have the potential to efficiently and reliably collect patient-reported health status measures among palliative care cancer patients presenting in clinics. The use of these devices may lead to substantial improvements by making patient-reported outcomes available for clinical decision-making.

  5. 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.

  6. Patient-Reported Outcomes After Multiligament Knee Injury

    PubMed Central

    Hanley, Jessica M.; Anthony, Christopher A.; DeMik, David; Glass, Natalie; Amendola, Annunziato; Wolf, Brian R.; Bollier, Matthew

    2017-01-01

    Background: Management of the medial collateral ligament (MCL) in the setting of a multiligamentous knee injury (MLKI) represents an area of great controversy. Purpose: Our study was designed to compare long-term patient-reported outcomes (PROs) after MCL repair versus reconstruction in the setting of a multiligamentous injury of the knee. Study Design: Cohort study; Level of evidence, 3. Methods: At a single institution, 68 patients were identified over a 10-year period as having MCL intervention in the setting of MLKI. Of these patients, 34 (50%) were successfully contacted via telephone to collect Lysholm and International Knee Documentation Committee (IKDC) scores. A retrospective chart review of these subjects was also conducted to identify patient and surgical factors affecting PROs. Results: At a mean 6-year follow-up (range, 2-11 years), the mean Lysholm score was 77.4 ± 23.1 and mean IKDC score was 72.6 ± 23.6. Univariate analyses identified time to surgery (P = .005) and MCL reconstruction (P = .001) as risk factors for Lysholm score ≤75. Univariate analyses identified patient age (P = .049), time to surgery (P = .018), and MCL reconstruction (P = .004) as risk factors for IKDC score ≤75. On subsequent multivariate analysis, MCL reconstruction was found to be a predictor of Lysholm or IKDC score of ≤75. Conclusion: Patients undergoing MCL repair in the setting of MLKI generally had higher PROs than those undergoing reconstructions at a mean 6 years of follow-up. Further work is needed to elucidate patient and surgical factors that may influence subjective outcomes after multiligament knee injuries. PMID:28357408

  7. 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

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

    PubMed

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

    2014-06-01

    Age, sex, and medical comorbidities may be associated with differences in patient-reported outcome scores after THA. Highest level of education may be a surrogate for socioeconomic status, but the degree to which this is associated with patient-reported outcomes after THA is not known. We investigated the national Swedish Hip Arthroplasty Register for the association of education attainment on patient-reported outcomes 1 year after THA; specifically, we evaluated level of education attainment against health-related quality of life (HRQoL), pain reduction, and satisfaction with treatment 1 year after THA. All THAs for osteoarthritis performed from 2005 through 2007 with complete patient-reported outcome measures (representing 49% of the THAs performed for this diagnosis) were selected from the Swedish Hip Arthroplasty Register. These cases were merged with national databases containing education attainment, marital status, and comorbidities (n = 11,464; mean age of patients, 64 years). The patient-reported outcome measure protocol included the HRQoL measure EuroQol five-dimension scale (EQ-5D), a VAS for pain, the Charnley classification survey, and a VAS addressing THA satisfaction. Linear regression analyses determined the association of preoperative patient factors with patient-reported outcomes. High education attainment was associated with higher HRQoL (EQ-5D index ß(high) = 0.03 ± 0.01; EQ VAS ß(high) = 2.6 ± 0.5) after THA, whereas those with low and medium education were at risk for lower HRQoL. High education was associated with less pain after treatment (ß(high) = -3.3 ± 0.05). Individuals with low or medium education were at risk for less satisfaction with THA (p < 0.001). Our results suggest clinicians should support patients with low and medium education to a greater extent. Identification of patients who will benefit most from THA and educating those at risk for poorer outcomes, like patients with low and medium education, ultimately may improve

  9. Patient-reported outcomes. How important are they?

    PubMed

    Korolija, D; Wood-Dauphinee, S; Pointner, R

    2007-04-01

    Outcome after surgical treatment has been based predominantly on objective criteria (biomedical model) and has largely ignored, until recently, the expectations, personal feelings, satisfaction, and quality of life of patients (outcomes model). The importance of this derives from considerations that the viewpoints and priorities of patients may not be the same as those of their surgeons. Furthermore, there is often little correlation between symptom severity and disease severity. Measures of quality of life and patient satisfaction are, thus, important in valid assessment of the results of surgical treatment. Global assessment based on both the biomedical and outcomes models constitutes the ideal. Questionnaires designed to measure both quality life (generic and specific) and patient satisfaction with treatment require careful development and validation by appropriate studies.

  10. Integrating patient reported outcome measures and computerized adaptive test estimates on the same common metric: an example from the assessment of activities in rheumatoid arthritis.

    PubMed

    Doğanay Erdoğan, Beyza; Elhan, Atilla Halİl; Kaskatı, Osman Tolga; Öztuna, Derya; Küçükdeveci, Ayşe Adile; Kutlay, Şehim; Tennant, Alan

    2015-07-14

    This study aimed to explore the potential of an inclusive and fully integrated measurement system for the Activities component of the International Classification of Functioning, Disability and Health (ICF), incorporating four classical scales, including the Health Assessment Questionnaire (HAQ), and a Computerized Adaptive Testing (CAT). Three hundred patients with rheumatoid arthritis (RA) answered relevant questions from four questionnaires. Rasch analysis was performed to create an item bank using this item pool. A further 100 RA patients were recruited for a CAT application. Both real and simulated CATs were applied and the agreement between these CAT-based scores and 'paper-pencil' scores was evaluated with intraclass correlation coefficient (ICC). Anchoring strategies were used to obtain a direct translation from the item bank common metric to the HAQ score. Mean age of 300 patients was 52.3 ± 11.7 years; disease duration was 11.3 ± 8.0 years; 74.7% were women. After testing for the assumptions of Rasch analysis, a 28-item Activities item bank was created. The agreement between CAT-based scores and paper-pencil scores were high (ICC = 0.993). Using those HAQ items in the item bank as anchoring items, another Rasch analysis was performed with HAQ-8 scores as separate items together with anchoring items. Finally a conversion table of the item bank common metric to the HAQ scores was created. A fully integrated and inclusive health assessment system, illustrating the Activities component of the ICF, was built to assess RA patients. Raw score to metric conversions and vice versa were available, giving access to the metric by a simple look-up table. © 2015 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.

  11. Physician-assessed and patient-reported outcome measures in chemotherapy-induced sensory peripheral neurotoxicity: two sides of the same coin.

    PubMed

    Alberti, P; Rossi, E; Cornblath, D R; Merkies, I S J; Postma, T J; Frigeni, B; Bruna, J; Velasco, R; Argyriou, A A; Kalofonos, H P; Psimaras, D; Ricard, D; Pace, A; Galiè, E; Briani, C; Dalla Torre, C; Faber, C G; Lalisang, R I; Boogerd, W; Brandsma, D; Koeppen, S; Hense, J; Storey, D; Kerrigan, S; Schenone, A; Fabbri, S; Valsecchi, M G; Cavaletti, G

    2014-01-01

    The different perception and assessment of chemotherapy-induced peripheral neurotoxicity (CIPN) between healthcare providers and patients has not yet been fully addressed, although these two approaches might eventually lead to inconsistent, possibly conflicting interpretation, especially regarding sensory impairment. A cohort of 281 subjects with stable CIPN was evaluated with the National Cancer Institute-Common Toxicity Criteria (NCI-CTC v. 2.0) sensory scale, the clinical Total Neuropathy Score (TNSc©), the modified Inflammatory Neuropathy Cause and Treatment (INCAT) sensory sumscore (mISS) and the European Organization for Research and Treatment of Cancer CIPN specific self-report questionnaire (EORTC QOL-CIPN20). Patients' probability estimates showed that the EORTC QLQ-CIPN20 sensory score was overall more highly related to the NCI-CTC sensory score. However, the vibration perception item of the TNSc had a higher probability to be scored 0 for EORTC QLQ-CIPN20 scores lower than 35, as vibration score 2 for EORTC QLQ-CIPN20 scores between 35 and 50 and as grade 3 or 4 for EORTC QLQ-CIPN20 scores higher than 50. The linear models showed a significant trend between each mISS item and increasing EORTC QLQ-CIPN20 sensory scores. None of the clinical items had a perfect relationship with patients' perception, and most of the discrepancies stood in the intermediate levels of CIPN severity. Our data indicate that to achieve a comprehensive knowledge of CIPN including a reliable assessment of both the severity and the quality of CIPN-related sensory impairment, clinical and PRO measures should be always combined.

  12. Physician-assessed and patient-reported outcome measures in chemotherapy-induced sensory peripheral neurotoxicity: two sides of the same coin

    PubMed Central

    Alberti, P.; Rossi, E.; Cornblath, D. R.; Merkies, I. S. J.; Postma, T. J.; Frigeni, B.; Bruna, J.; Velasco, R.; Argyriou, A. A.; Kalofonos, H. P.; Psimaras, D.; Ricard, D.; Pace, A.; Galiè, E.; Briani, C.; Dalla Torre, C.; Faber, C. G.; Lalisang, R. I.; Boogerd, W.; Brandsma, D.; Koeppen, S.; Hense, J.; Storey, D.; Kerrigan, S.; Schenone, A.; Fabbri, S.; Valsecchi, M. G.; Cavaletti, G.; Cavaletti, G.; Cornblath, D.R.; Merkies, I.S.J.; Postma, T.J.; Valsecchi, M.G; Galimberti, S.; Rossi, E.; Cavaletti, G.; Frigeni, B.; Lanzani, F.; Mattavelli, L.; Piatti, ML.; Alberti, P.; Binda, D.; Bidoli, P..; Cazzaniga, M.; Cortinovis, D.; Bruna, J.; Velasco, R.; Argyriou, AA.; Kalofonos, HP.; Psimaras, D.; Ricard, D.; Pace, A.; Galiè, E.; Briani, C.; Lucchetta, M.; Campagnolo, M.; Dalla Torre, C.; Merkies, ISJ.; Faber, CG.; Merkies, ISJ.; Vanhoutte, EK.; Bakkers, M.; Brouwer, B.; Lalisang, RI.; Boogerd, W.; Brandsma, D.; Koeppen, S.; Hense, J.; Grant, R.; Storey, D.; Kerrigan, S.; Schenone, A.; Reni, L.; Piras, B.; Fabbri, S.; Padua, L.; Granata, G.; Leandri, M.; Ghignotti, I.; Plasmati, R..; Pastorelli, F.; Postma, TJ.; Heimans, JJ.; Eurelings, M.; Meijer, RJ.; Grisold, W.; Lindeck Pozza, E.; Mazzeo, A.; Toscano, A.; Tomasello, C.; Altavilla, G.; Penas Prado, M.; Dominguez Gonzalez, C.; Dorsey, SG.; Brell, JM.

    2014-01-01

    Background The different perception and assessment of chemotherapy-induced peripheral neurotoxicity (CIPN) between healthcare providers and patients has not yet been fully addressed, although these two approaches might eventually lead to inconsistent, possibly conflicting interpretation, especially regarding sensory impairment. Patients and methods A cohort of 281 subjects with stable CIPN was evaluated with the National Cancer Institute—Common Toxicity Criteria (NCI-CTC v. 2.0) sensory scale, the clinical Total Neuropathy Score (TNSc©), the modified Inflammatory Neuropathy Cause and Treatment (INCAT) sensory sumscore (mISS) and the European Organization for Research and Treatment of Cancer CIPN specific self-report questionnaire (EORTC QOL-CIPN20). Results Patients' probability estimates showed that the EORTC QLQ-CIPN20 sensory score was overall more highly related to the NCI-CTC sensory score. However, the vibration perception item of the TNSc had a higher probability to be scored 0 for EORTC QLQ-CIPN20 scores lower than 35, as vibration score 2 for EORTC QLQ-CIPN20 scores between 35 and 50 and as grade 3 or 4 for EORTC QLQ-CIPN20 scores higher than 50. The linear models showed a significant trend between each mISS item and increasing EORTC QLQ-CIPN20 sensory scores. Conclusion None of the clinical items had a perfect relationship with patients' perception, and most of the discrepancies stood in the intermediate levels of CIPN severity. Our data indicate that to achieve a comprehensive knowledge of CIPN including a reliable assessment of both the severity and the quality of CIPN-related sensory impairment, clinical and PRO measures should be always combined. PMID:24256846

  13. Prevalence of swallowing and speech problems in daily life after chemoradiation for head and neck cancer based on cut-off scores of the patient-reported outcome measures SWAL-QOL and SHI.

    PubMed

    Rinkel, Rico N; Verdonck-de Leeuw, Irma M; Doornaert, Patricia; Buter, Jan; de Bree, Remco; Langendijk, Johannes A; Aaronson, Neil K; Leemans, C René

    2016-07-01

    The objective of this study is to assess swallowing and speech outcome after chemoradiation therapy for head and neck cancer, based on the patient-reported outcome measures Swallowing Quality of Life Questionnaire (SWAL-QOL) and Speech Handicap Index (SHI), both provided with cut-off scores. This is a cross-sectional study. Department of Otolaryngology/Head and Neck Surgery of a University Medical Center. Sixty patients, 6 months to 5 years after chemoradiation for head and neck squamous cell carcinoma. Swallowing Quality of Life Questionnaire (SWAL-QOL) and SHI, both validated in Dutch and provided with cut-off scores. Associations were tested between the outcome measures and independent variables (age, gender, tumor stage and site, and radiotherapy technique, time since treatment, comorbidity and food intake). Fifty-two patients returned the SWAL-QOL and 47 the SHI (response rate 87 and 78 %, respectively). Swallowing and speech problems were present in 79 and 55 %, respectively. Normal food intake was noticed in 45, 35 % had a soft diet and 20 % tube feeding. Patients with soft diet and tube feeding reported more swallowing problems compared to patients with normal oral intake. Tumor subsite was significantly associated with swallowing outcome (less problems in larynx/hypopharynx compared to oral/oropharynx). Radiation technique was significantly associated with psychosocial speech problems (less problems in patients treated with IMRT). Swallowing and (to a lesser extent) speech problems in daily life are frequently present after chemoradiation therapy for head and neck cancer. Future prospective studies will give more insight into the course of speech and swallowing problems after chemoradiation and into efficacy of new radiation techniques and swallowing and speech rehabilitation programs.

  14. Development and Feasibility Testing of PROMPT-Care, an eHealth System for Collection and Use of Patient-Reported Outcome Measures for Personalized Treatment and Care: A Study Protocol

    PubMed Central

    Delaney, Geoff P; Arnold, Anthony; Miller, Alexis Andrew; Levesque, Janelle V; Kaadan, Nasreen; Carolan, Martin G; Cook, Nicole; Masters, Kenneth; Tran, Thomas T; Sandell, Tiffany; Durcinoska, Ivana; Gerges, Martha; Avery, Sandra; Ng, Weng; Della-Fiorentina, Stephen; Dhillon, Haryana M; Maher, Ashley

    2016-01-01

    Background Patient-reported outcome (PRO) measures have been used widely to screen for depression, anxiety, and symptoms in cancer patients. Computer-based applications that collect patients’ responses and transfer them to the treating health professional in real time have the potential to improve patient well-being and cancer outcomes. Objective This study will test the feasibility and acceptability of a newly developed eHealth system which facilitates PRO data capture from cancer patients, data linkage and retrieval to support clinical decisions and patient self-management, and data retrieval to support ongoing evaluation and innovative research. Methods The eHealth system is being developed in consultation with 3 overarching content-specific expert advisory groups convened for this project: the clinical advisory group, technical advisory group, and evaluation advisory group. The following work has already been completed during this phase of the study: the Patient-Reported Outcome Measures for Personalized Treatment and Care (PROMPT-Care) eHealth system was developed, patient-reported outcomes were selected (distress, symptoms, unmet needs), algorithms to inform intervention thresholds for clinical and self-management were determined, clinician PRO feedback summary and longitudinal reports were designed, and patient self-management resources were collated. PROsaiq, a custom information technology system, will transfer PRO data in real time into the hospital-based oncology information system to support clinical decision making. The PROMPT-Care system feasibility and acceptability will be assessed through patients completing PROMPT-Care assessments, participating in face-to-face cognitive interviews, and completing evaluation surveys and telephone interviews and oncology staff participating in telephone interviews. Results Over the course of 3 months, the system will be pilot-tested with up to 50 patients receiving treatment or follow-up care and 6 oncology staff

  15. Development and Feasibility Testing of PROMPT-Care, an eHealth System for Collection and Use of Patient-Reported Outcome Measures for Personalized Treatment and Care: A Study Protocol.

    PubMed

    Girgis, Afaf; Delaney, Geoff P; Arnold, Anthony; Miller, Alexis Andrew; Levesque, Janelle V; Kaadan, Nasreen; Carolan, Martin G; Cook, Nicole; Masters, Kenneth; Tran, Thomas T; Sandell, Tiffany; Durcinoska, Ivana; Gerges, Martha; Avery, Sandra; Ng, Weng; Della-Fiorentina, Stephen; Dhillon, Haryana M; Maher, Ashley

    2016-11-24

    Patient-reported outcome (PRO) measures have been used widely to screen for depression, anxiety, and symptoms in cancer patients. Computer-based applications that collect patients' responses and transfer them to the treating health professional in real time have the potential to improve patient well-being and cancer outcomes. This study will test the feasibility and acceptability of a newly developed eHealth system which facilitates PRO data capture from cancer patients, data linkage and retrieval to support clinical decisions and patient self-management, and data retrieval to support ongoing evaluation and innovative research. The eHealth system is being developed in consultation with 3 overarching content-specific expert advisory groups convened for this project: the clinical advisory group, technical advisory group, and evaluation advisory group. The following work has already been completed during this phase of the study: the Patient-Reported Outcome Measures for Personalized Treatment and Care (PROMPT-Care) eHealth system was developed, patient-reported outcomes were selected (distress, symptoms, unmet needs), algorithms to inform intervention thresholds for clinical and self-management were determined, clinician PRO feedback summary and longitudinal reports were designed, and patient self-management resources were collated. PROsaiq, a custom information technology system, will transfer PRO data in real time into the hospital-based oncology information system to support clinical decision making. The PROMPT-Care system feasibility and acceptability will be assessed through patients completing PROMPT-Care assessments, participating in face-to-face cognitive interviews, and completing evaluation surveys and telephone interviews and oncology staff participating in telephone interviews. Over the course of 3 months, the system will be pilot-tested with up to 50 patients receiving treatment or follow-up care and 6 oncology staff at 2 hospitals in New South Wales

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

    PubMed

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

    2017-06-30

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

  17. Enhancing periodontal health through regenerative approaches: a commentary on the need for patient-reported outcomes.

    PubMed

    Inglehart, Marita R

    2015-02-01

    Starting in the 1970s, social scientists have discussed the importance of assessing subjective indicators of well-being and quality of life. Medical researchers followed this line of reasoning since the 1990s, emphasizing the significance of understanding how disease and its treatment affect patients' quality of life. Since the start of the 21(st) century, oral health-related quality of life (OHRQoL) received increasingly more attention. While research concerning the effects of periodontal disease and its surgical and non-surgical treatment on patients' lives has been considered in numerous studies, research including patient-reported outcomes when assessing how periodontal health can be enhanced through regenerative approaches is largely missing. This commentary proposes to consider 1) OHRQoL and 2) patients' treatment satisfaction as patient-reported outcomes in conjunction with objectively measured patient-centered factors, and discusses the value of such an approach.

  18. The Otology Questionnaire Amsterdam: a generic patient reported outcome measure about the severity and impact of ear complaints. A cross-sectional study on the development of this questionnaire.

    PubMed

    Bruinewoud, E M; Kraak, J T; van Leeuwen, L M; Kramer, S E; Merkus, P

    2017-08-03

    Development of the 'Otology Questionnaire Amsterdam' (OQUA), a patient reported outcome measure (PROM), measuring the severity and impact of ear complaints of patients visiting an ENT surgeon. Multicenter, cross-sectional study. Phase 1: qualitative research. In-depth interviews (N = 16) to identify relevant types of ear complaints and to formulate items. Pilot study of the first and second draft of the OQUA (N = 32, N = 39). Phase 2: quantitative research. Field-testing of the OQUA (N = 352). Item reduction based on inter-item correlation, factor analysis and expert opinion. Two secondary and two tertiary ENT clinics. Patients over the age of sixteen visiting an ENT surgeon with an ear complaint. Phase 1: meaning units and frequency of selected descriptions. Phase 2: inter-item correlation, factor loading and Cronbach's Alpha (α). Phase 1: eight relevant types of ear complaints were identified: earache, pressure in ear, hearing loss, tinnitus, otorrhoea, itch, dizziness and loss of taste. Phase 2: factor analysis generated a factor 'impact' (α = 0.913). The current version of the OQUA consists of 34 items, covers eight types of ear complaints and consists of two constructs: complaints and impact. The OQUA is a generic, otologic PROM designed to evaluate the severity of ear complaints and their impact on patients lives. © 2017 The Authors. Clinical Otolaryngology Published by John Wiley & Sons Ltd.

  19. Morning stiffness and other patient-reported outcomes of rheumatoid arthritis in clinical practice.

    PubMed

    Sokka, T

    2011-01-01

    Morning stiffness has been recognized in traditional approaches to assessment of disease activity in rheumatoid arthritis (RA). Although morning stiffness is not specific to RA, changes in morning stiffness for an individual patient are helpful when monitoring health status. Health professionals can ask about morning stiffness but the most accurate and consistent approach to assessment from one visit to the next appears to be a patient self-report questionnaire. However, quantitative measures of patient-reported data are not an integral part of clinical monitoring in most clinics. No single measure is adequate for all individual patients, so quantitative measurement of patient-reported data should include many elements such as pain, functional status, fatigue, sleep, morning stiffness, work capacity, and physical and emotional well-being. In daily clinical practice, patient-reported outcomes can be collected easily using a standard questionnaire that patients can complete with pencil and paper or electronically on a touch screen in the waiting room. The results are then immediately available to the rheumatologists, to facilitate doctor-patient communication to improve the quality of patient care, leading to better patient outcomes.

  20. eHealth System for Collecting and Utilizing Patient Reported Outcome Measures for Personalized Treatment and Care (PROMPT-Care) Among Cancer Patients: Mixed Methods Approach to Evaluate Feasibility and Acceptability.

    PubMed

    Girgis, Afaf; Durcinoska, Ivana; Levesque, Janelle V; Gerges, Martha; Sandell, Tiffany; Arnold, Anthony; Delaney, Geoff P

    2017-10-02

    Despite accumulating evidence indicating that collecting patient-reported outcomes (PROs) and transferring results to the treating health professional in real time has the potential to improve patient well-being and cancer outcomes, this practice is not widespread. The aim of this study was to test the feasibility and acceptability of PROMPT-Care (Patient Reported Outcome Measures for Personalized Treatment and Care), a newly developed electronic health (eHealth) system that facilitates PRO data capture from cancer patients, data linkage and retrieval to support clinical decisions and patient self-management, and data retrieval to support ongoing evaluation and innovative research. We developed an eHealth system in consultation with content-specific expert advisory groups and tested it with patients receiving treatment or follow-up care in two hospitals in New South Wales, Australia, over a 3-month period. Participants were recruited in clinic and completed self-report Web-based assessments either just before their upcoming clinical consultation or every 4 weeks if in follow-up care. A mixed methods approach was used to evaluate feasibility and acceptability of PROMPT-Care; data collected throughout the study informed the accuracy and completeness of data transfer procedures, and extent of missing data was determined from participants' assessments. Patients participated in cognitive interviews while completing their first assessment and completed evaluation surveys and interviews at study-end to assess system acceptability and usefulness of patient self-management resources, and oncology staff were interviewed at study-end to determine the acceptability and perceived usefulness of real-time PRO reporting. A total of 42 patients consented to the study; 7 patients were withdrawn before starting the intervention primarily because of changes in eligibility. Overall, 35 patients (13 on treatment and 22 in follow-up) completed 67 assessments during the study period. Mean

  1. 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.

  2. Strategies to use tablet computers for collection of electronic patient-reported outcomes.

    PubMed

    Schick-Makaroff, Kara; Molzahn, Anita

    2015-01-22

    Mobile devices are increasingly being used for data collection in research. However, many researchers do not have experience in collecting data electronically. Hence, the purpose of this short report was to identify issues that emerged in a study that incorporated electronic capture of patient-reported outcomes in clinical settings, and strategies used to address the issues. The issues pertaining to electronic patient-reported outcome data collection were captured qualitatively during a study on use of electronic patient-reported outcomes in two home dialysis units. Fifty-six patients completed three surveys on tablet computers, including the Kidney Disease Quality of Life-36, the Edmonton Symptom Assessment Scale, and a satisfaction measure. Issues that arose throughout the research process were recorded during ethics reviews, implementation process, and data collection. Four core issues emerged including logistics of technology, security, institutional and financial support, and electronic design. Although use of mobile devices for data collection has many benefits, it also poses new challenges for researchers. Advance consideration of possible issues that emerge in the process, and strategies that can help address these issues, may prevent disruption and enhance validity of findings.

  3. 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

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

    PubMed Central

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

    2016-01-01

    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

  5. 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.

  6. A disease-specific questionnaire for measuring patient-reported outcomes and experiences in the Swedish National Diabetes Register: Development and evaluation of content validity, face validity, and test-retest reliability.

    PubMed

    Svedbo Engström, Maria; Leksell, Janeth; Johansson, Unn-Britt; Eeg-Olofsson, Katarina; Borg, Sixten; Palaszewski, Bo; Gudbjörnsdottir, Soffia

    2017-07-14

    To describe the development and evaluation of the content and face validity and test-retest reliability of a disease-specific questionnaire that measures patient-reported outcomes and experiences for the Swedish National Diabetes Register for adult patients who have type 1 or type 2 diabetes. In this methodological study, a questionnaire was developed over four phases using an iterative process. Expert reviews and cognitive interviews were conducted to evaluate content and face validity, and a postal survey was administered to evaluate test-retest reliability. The expert reviews and cognitive interviews found the disease-specific questionnaire to be understandable, with relevant content and value for diabetes care. An item-level content validity index ranged from 0.6-1.0 and a scale content validity/average ranged from 0.7-1.0. The fourth version, with 33 items, two main parts and seven dimensions, was answered by 972 adults with type 1 and type 2 diabetes (response rate 61%). Weighted Kappa values ranged from 0.31-0.78 for type 1 diabetes and 0.27-0.74 for type 2 diabetes. This study describes the initial development of a disease-specific questionnaire in conjunction with the NDR. Content and face validity were confirmed and test-retest reliability was satisfactory. With the development of this questionnaire, the NDR becomes a clinical tool that contributes to further understanding the perspectives of adult individuals with diabetes. Copyright © 2017 Elsevier B.V. All rights reserved.

  7. Standardizing and personalizing the treat to target (T2T) approach for rheumatoid arthritis using the Patient-Reported Outcomes Measurement Information System (PROMIS): baseline findings on patient-centered treatment priorities.

    PubMed

    Bacalao, Emily J; Greene, George J; Beaumont, Jennifer L; Eisenstein, Amy; Muftic, Azra; Mandelin, Arthur M; Cella, David; Ruderman, Eric M

    2017-08-01

    A treat to target (T2T) approach to management has become the standard of care for patients with rheumatoid arthritis (RA). While consensus T2T recommendations call for patient involvement in the treatment process, the targets commonly used to drive therapeutic decisions involve limited patient input. A pilot study was developed to explore whether the Patient-Reported Outcomes Measurement Information System (PROMIS) could add value to the T2T approach by providing a way to bring patient goals into the process. We report here the baseline data from this study. RA patients from an academic rheumatology practice were recruited to participate in this 1-year study. Patients were asked to complete PROMIS computer-assisted testing at quarterly visits during the year. At baseline, they were asked to identify the PROMIS domain (Pain Interference, Fatigue, Depression, Physical Function, and Social Function) that felt most important to their quality of life. They were then asked to select five representative items from this domain, to be followed through the year. Complete baseline data was available for 119 patients. Most selected Physical Function (39%) or Pain Interference (37%) as their highest priority PROMIS domain. Sixty percent ranked Depression as their lowest priority domain. Younger patients more frequently prioritized Social Function, while older patients more frequently prioritized Fatigue. The incorporation of PROMIS questionnaires into routine clinic visits is a feasible mechanism for incorporating patient preferences into a T2T approach to managing RA.

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

    PubMed

    Ibsen, Charlotte; Schiøttz-Christensen, Berit; Melchiorsen, Hanne; Nielsen, Claus Vinther; Maribo, Thomas

    2016-07-18

    To link the items in the Patient-Reported Outcome Measures (PROMs): Roland Morris Disability Questionnaire, Short Form 36 (SF-36) and pain scores, to the Brief International Classification of Functioning, Disability and Health (ICF) Core Set for low back pain, and to examine the extent to which a clinician's assessment of patients' problems according to the Brief ICF Core Set correlates with the scores of matching items from the PROMs. The PROMs were linked to the Brief ICF Core Set for low back pain. Secondly, a cross-sectional study was conducted including 70 patients with low back pain. The patients completed the PROMs, and the Brief ICF Core Set for low back pain was assessed by a clinician using qualifiers. The items in the PROMs were successfully linked to the ICF. Twelve of the 38 unique ICF categories derived from the PROMs were covered by the Brief ICF Core Set (34%). A weak correlation was found between the patients' responses and the clinician's assessment. The selected PROMs do not cover the prototypical spectrum of problems encountered in patients with low back pain as defined by the Brief ICF Core Set. The clinical assessment of patients' problems according to the Brief ICF Core Set does not correlate with the scores of matching items from the PROMs.

  9. Validation of a Patient-reported Outcome (PRO) Measure and a Clinician-reported Outcome (CRO) Measure to Assess Satisfaction with Pharmacologic Stress Agents for Single-photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI).

    PubMed

    Hudgens, Stacie; Spalding, James; Chaudhari, Paresh

    2016-05-01

    The objective of this study was to develop and validate clinician and patient measures of satisfaction for pharmacologic stress agents (PSAs) used in single-photon emission computed tomography myocardial perfusion imaging procedures. Two questionnaires were developed: the Clinician Satisfaction and Preference Questionnaire (CSPQ) and the Patient Satisfaction and Preference Questionnaire (PSPQ). Items were developed, and the content validity of the questionnaires was ensured by participants' involvement in the item generation (5 clinician and 18 patient face-to-face concept elicitation interviews) and item modification phases (5 clinician and 10 patient face-to-face cognitive debriefing interviews). Psychometric validation of the satisfaction component of the questionnaires was conducted in a sample of 9 clinicians and 90 patients. After initial patient interviews and cognitive interviews, two 8-item instruments were developed with each containing an optional PSA preference question. The PSPQ assessed patients' receptiveness and satisfaction with the PSA that they received. The CSPQ assessed clinicians' satisfaction with the time and ease of PSA preparation, administration, and monitoring of the PSA. The optional preference question in both instruments assesses preference among PSAs. In a multicenter observational study of 88 patients and 9 clinicians, the PSPQ Preparation and Reaction to Agent scales elicited reliability coefficients of 0.90 and 0.87, respectively. In addition, the test-retest reliability was acceptable for all PSPQ scales (intraclass correlation coefficient range, 0.73-0.86). Concurrent validity with the Treatment Satisfaction Questionnaire for Medication (TSQM) indicates low-to-moderate correlations between the Effectiveness, Convenience, and Global Satisfaction scales of the TSQM with the PSPQ Satisfaction with Administration, Satisfaction with Effects, and Overall Satisfaction items (range, 0.46-0.78). Analysis of the CSPQ found that both the

  10. 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.

  11. 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.

  12. Responsiveness and minimally important difference for the patient-reported outcomes measurement information system (PROMIS) 20-item physical functioning short form in a prospective observational study of rheumatoid arthritis.

    PubMed

    Hays, Ron D; Spritzer, Karen L; Fries, James F; Krishnan, Eswar

    2015-01-01

    To estimate responsiveness (sensitivity to change) and minimally important difference (MID) for the Patient-Reported Outcomes Measurement Information System (PROMIS) 20-item physical functioning scale (PROMIS PF-20). The PROMIS PF-20, short form 36 (SF-36) physical functioning scale, and Health Assessment Questionnaire (HAQ) were administered at baseline, and 6 and 12 months later to a sample of 451 persons with rheumatoid arthritis. A retrospective change (anchor) item was administered at the 12-month follow-up. We estimated responsiveness between 12 months and baseline, and between 12 months and 6 months using one-way analysis of variance F-statistics. We estimated the MID for the PROMIS PF-20 using prospective change for people reporting getting 'a little better' or 'a little worse' on the anchor item. F-statistics for prospective change on the PROMIS PF-20, SF-36 and HAQ by the anchor item over 12 and 6 months (in parentheses) were 16.64 (14.98), 12.20 (7.92) and 10.36 (12.90), respectively. The MID for the PROMIS PF-20 was 2 points (about 0.20 of an SD). The PROMIS PF-20 is more responsive than two widely used ('legacy') measures. The MID is a small effect size. The measure can be useful for assessing physical functioning in clinical trials and observational studies. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  13. 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

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

    PubMed

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

    2016-09-01

    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.
. A systematic electronic literature search was conducted using PubMed, EMBASE, Scopus, PsycINFO®, Cochrane Library, Web of Science, and CINAHL® databases through November 2014. 
. 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.
. 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.
. 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. 
. 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.

  15. Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer

    PubMed Central

    Mason, M.; Metcalfe, C.; Walsh, E.; Blazeby, J.M.; Peters, T.J.; Holding, P.; Bonnington, S.; Lennon, T.; Bradshaw, L.; Cooper, D.; Herbert, P.; Howson, J.; Jones, A.; Lyons, N.; Salter, E.; Thompson, P.; Tidball, S.; Blaikie, J.; Gray, C.; Bollina, P.; Catto, J.; Doble, A.; Doherty, A.; Gillatt, D.; Kockelbergh, R.; Kynaston, H.; Paul, A.; Powell, P.; Prescott, S.; Rosario, D.J.; Rowe, E.; Davis, M.; Turner, E.L.; Martin, R.M.

    2016-01-01

    Background Robust data on patient-reported outcome measures comparing treatments for clinically localized prostate cancer are lacking. We investigated the effects of active monitoring, radical prostatectomy, and radical radiotherapy with hormones on patient-reported outcomes. Methods We compared patient-reported outcomes among 1643 men in the Prostate Testing for Cancer and Treatment (ProtecT) trial who completed questionnaires before diagnosis, at 6 and 12 months after randomization, and annually thereafter. Patients completed validated measures that assessed urinary, bowel, and sexual function and specific effects on quality of life, anxiety and depression, and general health. Cancer-related quality of life was assessed at 5 years. Complete 6-year data were analyzed according to the intention-to-treat principle. Results The rate of questionnaire completion during follow-up was higher than 85% for most measures. Of the three treatments, prostatectomy had the greatest negative effect on sexual function and urinary continence, and although there was some recovery, these outcomes remained worse in the prostatectomy group than in the other groups throughout the trial. The negative effect of radiotherapy on sexual function was greatest at 6 months, but sexual function then recovered somewhat and was stable thereafter; radiotherapy had little effect on urinary continence. Sexual and urinary function declined gradually in the active-monitoring group. Bowel function was worse in the radiotherapy group at 6 months than in the other groups but then recovered somewhat, except for the increasing frequency of bloody stools; bowel function was unchanged in the other groups. Urinary voiding and nocturia were worse in the radiotherapy group at 6 months but then mostly recovered and were similar to the other groups after 12 months. Effects on quality of life mirrored the reported changes in function. No significant differences were observed among the groups in measures of anxiety

  16. Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer.

    PubMed

    Donovan, Jenny L; Hamdy, Freddie C; Lane, J Athene; Mason, Malcolm; Metcalfe, Chris; Walsh, Eleanor; Blazeby, Jane M; Peters, Tim J; Holding, Peter; Bonnington, Susan; Lennon, Teresa; Bradshaw, Lynne; Cooper, Deborah; Herbert, Phillipa; Howson, Joanne; Jones, Amanda; Lyons, Norma; Salter, Elizabeth; Thompson, Pauline; Tidball, Sarah; Blaikie, Jan; Gray, Catherine; Bollina, Prasad; Catto, James; Doble, Andrew; Doherty, Alan; Gillatt, David; Kockelbergh, Roger; Kynaston, Howard; Paul, Alan; Powell, Philip; Prescott, Stephen; Rosario, Derek J; Rowe, Edward; Davis, Michael; Turner, Emma L; Martin, Richard M; Neal, David E

    2016-10-13

    Background Robust data on patient-reported outcome measures comparing treatments for clinically localized prostate cancer are lacking. We investigated the effects of active monitoring, radical prostatectomy, and radical radiotherapy with hormones on patient-reported outcomes. Methods We compared patient-reported outcomes among 1643 men in the Prostate Testing for Cancer and Treatment (ProtecT) trial who completed questionnaires before diagnosis, at 6 and 12 months after randomization, and annually thereafter. Patients completed validated measures that assessed urinary, bowel, and sexual function and specific effects on quality of life, anxiety and depression, and general health. Cancer-related quality of life was assessed at 5 years. Complete 6-year data were analyzed according to the intention-to-treat principle. Results The rate of questionnaire completion during follow-up was higher than 85% for most measures. Of the three treatments, prostatectomy had the greatest negative effect on sexual function and urinary continence, and although there was some recovery, these outcomes remained worse in the prostatectomy group than in the other groups throughout the trial. The negative effect of radiotherapy on sexual function was greatest at 6 months, but sexual function then recovered somewhat and was stable thereafter; radiotherapy had little effect on urinary continence. Sexual and urinary function declined gradually in the active-monitoring group. Bowel function was worse in the radiotherapy group at 6 months than in the other groups but then recovered somewhat, except for the increasing frequency of bloody stools; bowel function was unchanged in the other groups. Urinary voiding and nocturia were worse in the radiotherapy group at 6 months but then mostly recovered and were similar to the other groups after 12 months. Effects on quality of life mirrored the reported changes in function. No significant differences were observed among the groups in measures of anxiety

  17. Heterogeneity in Patient-Reported Outcomes following Low-Intensity Mental Health Interventions: A Multilevel Analysis

    PubMed Central

    Ali, Shehzad; Littlewood, Elizabeth; McMillan, Dean; Delgadillo, Jaime; Miranda, Alfonso; Croudace, Tim; Gilbody, Simon

    2014-01-01

    Background Variability in patient-reported outcomes of psychological treatments has been partly attributed to therapists – a phenomenon commonly known as therapist effects. Meta-analytic reviews reveal wide variation in therapist-attributable variability in psychotherapy outcomes, with most studies reporting therapist effects in the region of 5% to 10% and some finding minimal to no therapist effects. However, all except one study to date have been conducted in high-intensity or mixed intervention groups; therefore, there is scarcity of evidence on therapist effects in brief low-intensity psychological interventions. Objective To examine therapist effects in low-intensity interventions for depression and anxiety in a naturalistic setting. Data and Analysis Session-by-session data on patient-reported outcome measures were available for a cohort of 1,376 primary care psychotherapy patients treated by 38 therapists. Outcome measures included PHQ-9 (sensitive to depression) and GAD-7 (sensitive to general anxiety disorder) measures. Three-level hierarchical linear modelling was employed to estimate therapist-attributable proportion of variance in clinical outcomes. Therapist effects were evaluated using the intra-cluster correlation coefficient (ICC) and Bayesian empirical predictions of therapist random effects. Three sensitivity analyses were conducted: 1) using both treatment completers and non-completers; 2) a sub-sample of cases with baseline scores above the conventional clinical thresholds for PHQ-9 and GAD-7; and 3) a two-level model (using patient-level pre- and post-treatment scores nested within therapists). Results The ICC estimates for all outcome measures were very small, ranging between 0% and 1.3%, although most were statistically significant. The Bayesian empirical predictions showed that therapist random effects were not statistically significantly different from each other. Between patient variability explained most of the variance in outcomes

  18. Evolution of Patient-Reported Outcomes and Their Role in Multiple Sclerosis Clinical Trials.

    PubMed

    Nowinski, Cindy J; Miller, Deborah M; Cella, David

    2017-09-14

    Patient-reported outcomes (PROs) are playing an increasing role in multiple sclerosis (MS) research and practice, and are essential for understanding the effects that MS and MS treatments have on patients' lives. PROs are captured directly from patients and include symptoms, function, health status, and health-related quality of life. In this article, we review different categories (e.g., generic, targeted, preference-based) of PRO measures and considerations in selecting a measure. The PROs included in MS clinical research have evolved over time, as have the measures used to assess them. We describe findings from recent MS clinical trials that included PROs when evaluating Food and Drug Administration-approved disease-modifying therapies (e.g., daclizumab, teriflunomide). Variation in the measures used in these trials makes it difficult to draw any conclusions from the data. We therefore suggest a standardized approach to PRO assessment in MS research and describe 2 generic, National Institutes of Health-supported measurement systems [Neuro-QoL and the Patient-Reported Outcomes Measurement Information System (PROMIS)] that would facilitate such an approach. The use of PROs in MS care and research is expanding beyond clinical trials, as is demonstrated by examples from comparative effectiveness and other patient-centered research. The importance of PRO assessment is expected to continue to grow in the future.

  19. Utilizing Multidimensional Computer Adaptive Testing to Mitigate Burden With Patient Reported Outcomes.

    PubMed

    Bass, Michael; Morris, Scott; Neapolitan, Richard

    Utilization of patient-reported outcome measures (PROs) had been limited by the lack of psychometrically sound measures scored in real-time. The Patient Reported Outcomes Measurement Information System (PROMIS) initiative developed a broad array of high-quality PRO measures. Towards reducing the number of items administered in measuring PROs, PROMIS employs Item Response Theory (IRT) and Computer Adaptive Testing (CAT). By only administering questions targeted to the subject's trait level, CAT has cut testing times in half(1). The IRT/CAT implementation in PROMIS is unidimensional in that there is a separate set of questions administered for each measured trait. However, there are often correlations among traits. Multidimensional IRT (MIRT) and multidimensional CAT (MCAT) provide items concerning several correlated traits, and should ameliorate patient burden. We developed an MIRT model using existing PROMIS item banks for depression and anxiety, developed MCAT software, and compared the efficiency of the MCAT approach to the unidimensional approach. Note: Research reported in this publication was supported in part by the National Library of Medicine of the National Institutes of Health under Award Number R01LM011962.

  20. 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

  1. 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.

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

    PubMed Central

    2011-01-01

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

  3. Mandibular complete denture versus single-implant overdenture: a systematic review of patient-reported outcomes.

    PubMed

    Nogueira, T E; Dias, D R; Leles, C R

    2017-08-14

    The single-implant mandibular overdenture (SIMO) has been proposed as an alternative for edentulous patients who are poorly adapted to their dentures due to low retention and stability of the conventional mandibular complete denture (CD). However, there is a lack of evidence regarding the effectiveness of SIMO, which can be measured by examining patient perception of treatment effects. The aim of this systematic review was to assess the comparative results of CD and SIMO treatments using patient-reported outcome measures. A literature search was carried out in PubMed, Scopus and Cochrane Central databases. The search included studies published up to July 2017. The focus question was: 'Do single-implant mandibular overdentures improve patient-reported outcomes compared to conventional complete dentures in edentulous patients?' Eligible studies were randomised clinical trials (RCT) and prospective studies. After initial screening for eligibility and full-text analysis, 11 studies were included for data extraction and quality assessment (five parallel-group RCTs, two crossover RCTs and four prospective studies). All studies reported marked improvement in satisfaction with the dentures and quality of life measures after SIMO treatment, irrespective of variations in implant treatment protocols and retention systems. Methodological considerations revealed a lack of evidence from RCTs on the comparative effectiveness of the two treatment strategies. Hence, although available evidence suggests considerable improvement in patient-reported outcomes following the insertion of a single implant to retain a mandibular denture, further well-designed comparative studies between SIMO and CD are required to improve the level of evidence and to support the indication of SIMO treatment in routine practice. © 2017 John Wiley & Sons Ltd.

  4. Integrating Patient Reported Outcomes With Clinical Cancer Registry Data: A Feasibility Study of the Electronic Patient-Reported Outcomes From Cancer Survivors (ePOCS) System

    PubMed Central

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

    2013-01-01

    Background Routine measurement of Patient Reported Outcomes (PROs) linked with clinical data across the patient pathway is increasingly important for informing future care planning. The innovative electronic Patient-reported Outcomes from Cancer Survivors (ePOCS) system was developed to integrate PROs, collected online at specified post-diagnostic time-points, with clinical and treatment data in cancer registries. Objective This study tested the technical and clinical feasibility of ePOCS by running the system with a sample of potentially curable breast, colorectal, and prostate cancer patients in their first 15 months post diagnosis. Methods Patients completed questionnaires comprising multiple Patient Reported Outcome Measures (PROMs) via ePOCS within 6 months (T1), and at 9 (T2) and 15 (T3) months, post diagnosis. Feasibility outcomes included system informatics performance, patient recruitment, retention, representativeness and questionnaire completion (response rate), patient feedback, and administration burden involved in running the system. Results ePOCS ran efficiently with few technical problems. Patient participation was 55.21% (636/1152) overall, although varied by approach mode, and was considerably higher among patients approached face-to-face (61.4%, 490/798) than by telephone (48.8%, 21/43) or letter (41.0%, 125/305). Older and less affluent patients were less likely to join (both P<.001). Most non-consenters (71.1%, 234/329) cited information technology reasons (ie, difficulty using a computer). Questionnaires were fully or partially completed by 85.1% (541/636) of invited participants at T1 (80 questions total), 70.0% (442/631) at T2 (102-108 questions), and 66.3% (414/624) at T3 (148-154 questions), and fully completed at all three time-points by 57.6% (344/597) of participants. Reminders (mainly via email) effectively prompted responses. The PROs were successfully linked with cancer registry data for 100% of patients (N=636). Participant feedback

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

    PubMed

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

    2013-10-25

    Routine measurement of Patient Reported Outcomes (PROs) linked with clinical data across the patient pathway is increasingly important for informing future care planning. The innovative electronic Patient-reported Outcomes from Cancer Survivors (ePOCS) system was developed to integrate PROs, collected online at specified post-diagnostic time-points, with clinical and treatment data in cancer registries. This study tested the technical and clinical feasibility of ePOCS by running the system with a sample of potentially curable breast, colorectal, and prostate cancer patients in their first 15 months post diagnosis. Patients completed questionnaires comprising multiple Patient Reported Outcome Measures (PROMs) via ePOCS within 6 months (T1), and at 9 (T2) and 15 (T3) months, post diagnosis. Feasibility outcomes included system informatics performance, patient recruitment, retention, representativeness and questionnaire completion (response rate), patient feedback, and administration burden involved in running the system. ePOCS ran efficiently with few technical problems. Patient participation was 55.21% (636/1152) overall, although varied by approach mode, and was considerably higher among patients approached face-to-face (61.4%, 490/798) than by telephone (48.8%, 21/43) or letter (41.0%, 125/305). Older and less affluent patients were less likely to join (both P<.001). Most non-consenters (71.1%, 234/329) cited information technology reasons (ie, difficulty using a computer). Questionnaires were fully or partially completed by 85.1% (541/636) of invited participants at T1 (80 questions total), 70.0% (442/631) at T2 (102-108 questions), and 66.3% (414/624) at T3 (148-154 questions), and fully completed at all three time-points by 57.6% (344/597) of participants. Reminders (mainly via email) effectively prompted responses. The PROs were successfully linked with cancer registry data for 100% of patients (N=636). Participant feedback was encouraging and positive, with

  6. Evidence-Based Medicine in Otolaryngology, Part 6: Patient-Reported Outcomes in Clinical Practice.

    PubMed

    Carroll, Thomas L; Lee, Stella E; Lindsay, Robin; Locandro, Drew; Randolph, Gregory W; Shin, Jennifer J

    2017-09-01

    The assessment of patient-reported outcome measures (PROMs) in the outpatient setting is gaining momentum in clinical and research venues. Implementing this data capture into one's practice, however, is not a one-size-fits-all venture, and it is critical to determine when, how, and where to include these patient-centered assessments. This installment of the "Evidence-Based Medicine in Otolaryngology" series provides insight into the implementation process and experiences with successful incorporation of PROMs into clinical practice. Specifically, 4 differing clinical scenarios and collection techniques are described, including data acquisition protocols, formats for clinician data usage, and applications of PROM results in clinical and research scenarios.

  7. 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

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

    2016-03-24

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

  8. 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

  9. Patient-reported outcomes with lanreotide Autogel/Depot for carcinoid syndrome: An international observational study.

    PubMed

    Ruszniewski, Philippe; Valle, Juan W; Lombard-Bohas, Catherine; Cuthbertson, Daniel J; Perros, Petros; Holubec, Luboš; Delle Fave, Gianfranco; Smith, Denis; Niccoli, Patricia; Maisonobe, Pascal; Atlan, Philippe; Caplin, Martyn E

    2016-05-01

    Lanreotide Autogel/Depot effectively controls symptoms in patients with carcinoid syndrome associated with neuroendocrine tumours. Data on patient-reported outcomes are sparse. To evaluate the effect of lanreotide on patient-reported outcomes (PROs) with carcinoid syndrome. This was an international, open-label, observational study of adults with neuroendocrine tumours and history of diarrhoea, receiving lanreotide for >3 months for relief of carcinoid syndrome symptoms. The primary PRO measure was satisfaction with diarrhoea control. Secondary PRO measures included severity, change in symptoms and impact on daily life of diarrhoea; and patient satisfaction with flushing control. Of 273 patients enrolled, 76% were 'completely' or 'rather' satisfied with diarrhoea control; 79% reported improvement in diarrhoea with lanreotide. The proportion of patients with 'mild', 'minimal', or 'no diarrhoea' increased from 33% before treatment to 75% during treatment; 75% were unconcerned about the impact of diarrhoea on daily life. Satisfaction with flushing control amongst patients with significant flushing at treatment initiation was 73%. Lanreotide treatment was associated with improvements in symptoms as well as a range of PROs in patients with neuroendocrine tumours and carcinoid syndrome (ClinicalTrials.gov: NCT01234168). Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  10. Effect of Intensive Blood-Pressure Treatment on Patient-Reported Outcomes.

    PubMed

    Berlowitz, Dan R; Foy, Capri G; Kazis, Lewis E; Bolin, Linda P; Conroy, Molly B; Fitzpatrick, Peter; Gure, Tanya R; Kimmel, Paul L; Kirchner, Kent; Morisky, Donald E; Newman, Jill; Olney, Christine; Oparil, Suzanne; Pajewski, Nicholas M; Powell, James; Ramsey, Thomas; Simmons, Debra L; Snyder, Joni; Supiano, Mark A; Weiner, Daniel E; Whittle, Jeff

    2017-08-24

    The previously published results of the Systolic Blood Pressure Intervention Trial showed that among participants with hypertension and an increased cardiovascular risk, but without diabetes, the rates of cardiovascular events were lower among those who were assigned to a target systolic blood pressure of less than 120 mm Hg (intensive treatment) than among those who were assigned to a target of less than 140 mm Hg (standard treatment). Whether such intensive treatment affected patient-reported outcomes was uncertain; those results from the trial are reported here. We randomly assigned 9361 participants with hypertension to a systolic blood-pressure target of less than 120 mm Hg or a target of less than 140 mm Hg. Patient-reported outcome measures included the scores on the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the Veterans RAND 12-Item Health Survey, the Patient Health Questionnaire 9-item depression scale (PHQ-9), patient-reported satisfaction with their blood-pressure care and blood-pressure medications, and adherence to blood-pressure medications. We compared the scores in the intensive-treatment group with those in the standard-treatment group among all participants and among participants stratified according to physical and cognitive function. Participants who received intensive treatment received an average of one additional antihypertensive medication, and the systolic blood pressure was 14.8 mm Hg (95% confidence interval, 14.3 to 15.4) lower in the group that received intensive treatment than in the group that received standard treatment. Mean PCS, MCS, and PHQ-9 scores were relatively stable over a median of 3 years of follow-up, with no significant differences between the two treatment groups. No significant differences between the treatment groups were noted when participants were stratified according to baseline measures of physical or cognitive function. Satisfaction with blood-pressure care was high in both treatment

  11. Joint modeling of multiple longitudinal patient-reported outcomes and survival

    PubMed Central

    Hatfield, Laura A.; Boye, Mark E.; Carlin, Bradley P.

    2011-01-01

    Researchers often include patient-reported outcomes (PROs) in Phase III clinical trials to demonstrate the value of treatment from the patient’s perspective. These data are collected as longitudinal repeated measures and are often censored by occurrence of a clinical event that defines a survival time. Hierarchical Bayesian models having latent individual-level trajectories provide a flexible approach to modeling such multiple outcome types simultaneously. We consider the case of many zeros in the longitudinal data motivating a mixture model, and demonstrate several approaches to modeling multiple longitudinal PROs with survival in a cancer clinical trial. These joint models may enhance Phase III analyses and better inform health care decision makers. PMID:21830926

  12. Feasibility of Frequent Patient-Reported Outcome Surveillance in Patients Undergoing Hematopoietic Cell Transplantation

    PubMed Central

    Wood, William A.; Deal, Allison M.; Abernethy, Amy; Basch, Ethan; Battaglini, Claudio; Kim, Yoon Hie; Whitley, Julia; Shatten, Charlotte; Serody, Jon; Shea, Thomas; Reeve, Bryce B.

    2012-01-01

    Patient-reported outcomes (PROs), including symptoms and health-related quality of life (HRQOL), provide a patient-centered description of hematopoietic cell transplantation (HCT)-related toxicity. These data characterize the patient experience after HCT and may have prognostic usefulness for long-term outcomes after HCT. We conducted a study of 32 patients after HCT (10 autologous HCT recipients, 11 full-intensity conditioning allogeneic HCT recipients, and 11 reduced-intensity conditioning allogeneic HCT recipients) to determine the feasibility of weekly electronic PRO collection from HCT until day (D) + 100. We used questions from the PRO version of the Common Terminology Criteria for Adverse Events to capture symptoms, and the Patient-Reported Outcomes Measurement Information System Global Health scale to measure physical and mental HRQOL. The vast majority (94%) of patients used the electronic PRO system, with only 6% opting for paper-and-pencil only. The median weekly percentage of participants who completed the surveys was 100% in all cohorts through hospital discharge, and remained 100% for the autologous HCT and reduced-intensity allogeneic HCT cohorts through D+100. Patients were satisfied with the electronic system, giving high marks for readability, comfort, and questionnaire length. Symptom severity varied by absolute level and type of symptom across the 3 cohorts, with the full-intensity allogeneic HCT cohort exhibiting the greatest median overall symptom severity, peaking at D+7. Median physical health HRQOL scores decreased with time in the 3 cohorts, and HRQOL was generally correlated with overall symptom severity. Our results demonstrate the feasibility of frequent electronic PROs in the early post-HCT period. Future studies in larger populations to explore predictive models using frequent PRO data for outcomes, including long-term HRQOL and survival, are warranted. PMID:23253558

  13. Incorporating Patient-Reported Outcomes Into Health Care To Engage Patients And Enhance Care.

    PubMed

    Lavallee, Danielle C; Chenok, Kate E; Love, Rebecca M; Petersen, Carolyn; Holve, Erin; Segal, Courtney D; Franklin, Patricia D

    2016-04-01

    The provision of patient-centered care requires a health care environment that fosters engagement between patients and their health care team. One way to encourage patient-centered care is to incorporate patient-reported outcomes into clinical settings. Collecting these outcomes in routine care ensures that important information only the patient can provide is captured. This provides insights into patients' experiences of symptoms, quality of life, and functioning; values and preferences; and goals for health care. Previously embraced in the research realm, patient-reported outcomes have started to play a role in successful shared decision making, which can enhance the safe and effective delivery of health care. We examine the opportunities for using patient-reported outcomes to enhance care delivery and outcomes as health care information needs and technology platforms change. We highlight emerging practices in which patient-reported outcomes provide value to patients and clinicians and improve care delivery. Finally, we examine present and future challenges to maximizing the use of patient-reported outcomes in the clinic.

  14. Patient-reported outcomes in core domain sets for rheumatic diseases.

    PubMed

    van Tuyl, Lilian H D; Boers, Maarten

    2015-12-01

    Patient-reported outcomes (PROs) are abundant in rheumatology and their numbers continue to increase. But which of the available measures are most important? Core outcome sets-including groups of domains and instruments for measuring them-have been defined for many rheumatic diseases, with the aim that all these outcomes should be measured in every clinical trial. The subgroup of PROs included in these core sets is, therefore, undoubtedly important. This Review summarizes the PROs included in core outcome sets developed for use in clinical trials across a wide range of rheumatic diseases. Three PROs are commonly utilized across the majority of rheumatic conditions: pain, physical functioning and the patient global assessment of disease activity. However, additional research is needed to fully understand the role of the patient global assessment of disease activity, to distinguish specific domains within the broad concept of health-related quality of life, and to work towards consensus on the choice between generic and disease-specific instruments in various contexts.

  15. Do Patient-Reported Outcomes Have a Role in the Management of Patients with Cystic Fibrosis?

    PubMed Central

    Salek, M. Sam; Jones, S.; Rezaie, M.; Davies, C.; Mills, R.; Ketchell, R. I.

    2011-01-01

    Background: Health-related quality of life (HRQoL) is a rapidly growing area of expertise and the most commonly used patient-reported outcome (PRO). The impact of cystic fibrosis (CF) on HRQoL is liable to be great, making CF patients ideal candidates for the application of HRQoL instruments. The aims of this study were to assess the affect of CF on HRQoL, to ascertain the reliability and validity of the United Kingdom Sickness Impact Profile (UKSIP) and the Cystic Fibrosis Quality of Life Questionnaire (CFQoL) in the adult CF population, and to examine their role in the management of patients. Methods: Seventy participants were recruited from the All Wales Adult Cystic Fibrosis Centre at Llandough Hospital, UK. There were two stages to the study: self-report of the UKSIP and CFQoL; and completion of the same two questionnaires 7–10 days later. Results: The areas of HRQoL most impaired by CF were employment and concerns regarding the future. The UKSIP and CFQoL showed high internal consistency (rα = 0.89–0.93) and test–retest reliability (rs = 0.57–0.94, p < 0.005) in the CF population. Validity was variable with the UKSIP showing discrimination across socio-demographic factors, whilst the CFQoL showed increased sensitivity to clinical variables. Many parameters influenced patient-reported HRQoL, with the greatest correlations seen with the Borg score (p < 0.005). The use of a HRQoL instrument in CF annual reviews is recommended to provide holistic patient care. The results of this study underpin the value of HRQoL as a patient-reported outcome measure in the management of adult CF. PMID:22416231

  16. Patient-reported outcomes of pain and physical functioning in neurofibromatosis clinical trials.

    PubMed

    Wolters, Pamela L; Martin, Staci; Merker, Vanessa L; Tonsgard, James H; Solomon, Sondra E; Baldwin, Andrea; Bergner, Amanda L; Walsh, Karin; Thompson, Heather L; Gardner, Kathy L; Hingtgen, Cynthia M; Schorry, Elizabeth; Dudley, William N; Franklin, Barbara

    2016-08-16

    Tumors and other disease complications of neurofibromatosis (NF) can cause pain and negatively affect physical functioning. To document the clinical benefit of treatment in NF trials targeting these manifestations, patient-reported outcomes (PROs) assessing pain and physical functioning should be included as study endpoints. Currently, there is no consensus on the selection and use of such measures in the NF population. This article presents the recommendations of the PRO group of the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) International Collaboration for assessing the domains of pain and physical functioning for NF clinical trials. The REiNS PRO group reviewed and rated existing PRO measures assessing pain intensity, pain interference, and physical functioning using their systematic method. Final recommendations are based primarily on 4 main criteria: patient characteristics, item content, psychometric properties, and feasibility for clinical trials. The REiNS PRO group chose the Numeric Rating Scale-11 (≥8 years) to assess pain intensity, the Pain Interference Index (6-24 years) and the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Scale (≥18 years) to evaluate pain interference, and the PROMIS Physical Functioning Scale to measure upper extremity function and mobility (≥5 years) for NF clinical trials. The REiNS Collaboration currently recommends these PRO measures to assess the domains of pain and physical functioning for NF clinical trials; however, further research is needed to evaluate their use in individuals with NF. A final consensus recommendation for the pain interference measure will be disseminated in a future publication based on findings from additional published research. © 2016 American Academy of Neurology.

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

    PubMed

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

    2017-09-24

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

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

    PubMed

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

    2017-09-01

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

  19. Life after prostate cancer diagnosis: protocol for a UK-wide patient-reported outcomes study

    PubMed Central

    Downing, Amy; Wright, Penny; Wagland, Richard; Watson, Eila; Kearney, Therese; Mottram, Rebecca; Allen, Majorie; Cairnduff, Victoria; McSorley, Oonagh; Butcher, Hugh; Hounsome, Luke; Donnelly, Conan; Selby, Peter; Kind, Paul; Cross, William; Catto, James W H; Huws, Dyfed; Brewster, David H; McNair, Emma; Matheson, Lauren; Rivas, Carol; Nayoan, Johana; Horton, Mike; Corner, Jessica; Verne, Julia; Gavin, Anna; Glaser, Adam W

    2016-01-01

    Background Prostate cancer and its treatment may impact physically, psychologically and socially; affecting the health-related quality of life of men and their partners/spouses. The Life After Prostate Cancer Diagnosis (LAPCD) study is a UK-wide patient-reported outcomes study which will generate information to improve the health and well-being of men with prostate cancer. Methods and analysis Postal surveys will be sent to prostate cancer survivors (18–42 months postdiagnosis) in all 4 UK countries (n=∼70 000). Eligible men will be identified and/or verified through cancer registration systems. Men will be surveyed twice, 12 months apart, to explore changes in outcomes over time. Second, separate cohorts will be surveyed once and the design will include evaluation of the acceptability of online survey tools. A comprehensive patient-reported outcome measure has been developed using generic and specific instruments with proven psychometric properties and relevance in national and international studies. The outcome data will be linked with administrative health data (eg, treatment information from hospital data). To ensure detailed understanding of issues of importance, qualitative interviews will be undertaken with a sample of men who complete the survey across the UK (n=∼150) along with a small number of partners/spouses (n=∼30). Ethics and dissemination The study has received the following approvals: Newcastle and North Tyneside 1 Research Ethics Committee (15/NE/0036), Health Research Authority Confidentiality Advisory Group (15/CAG/0110), NHS Scotland Public Benefit and Privacy Panel (0516-0364), Office of Research Ethics Northern Ireland (16/NI/0073) and NHS R&D approval from Wales, Scotland and Northern Ireland. Using traditional and innovative methods, the results will be made available to men and their partners/spouses, the funders, the NHS, social care, voluntary sector organisations and other researchers. PMID:27927667

  20. Framework and guidance for implementing patient-reported outcomes in clinical practice: evidence, challenges and opportunities.

    PubMed

    Porter, Ian; Gonçalves-Bradley, Daniela; Ricci-Cabello, Ignacio; Gibbons, Chris; Gangannagaripalli, Jaheeda; Fitzpatrick, Ray; Black, Nick; Greenhalgh, Joanne; Valderas, Jose M

    2016-08-01

    Patient-reported outcomes (PROs) are reports of the status of a patient's health condition that come directly from the patient. While PRO measures are a well-developed technology with robust standards in research, their use for informing healthcare decisions is still poorly understood. We review relevant examples of their application in the provision of healthcare and examine the challenges associated with implementing PROs in clinical settings. We evaluate evidence for their use and examine barriers to their uptake, and present an evidence-based framework for the successful implementation of PROs in clinical practice. We discuss current and future developments for the use of PROs in clinical practice, such as individualized measurement and computer-adaptive testing.

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

    PubMed Central

    2011-01-01

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

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

    PubMed Central

    Emery, Marie-Pierre; Perrier, Laure-Lou; Acquadro, Catherine

    2005-01-01

    The exponential development of Patient-Reported Outcomes (PRO) measures in clinical research has led to the creation of the Patient-Reported Outcome and Quality of Life Instruments Database (PROQOLID) to facilitate the selection process of PRO measures in clinical research. The project was initiated by Mapi Research Trust in Lyon, France. Initially called QOLID (Quality of Life Instruments Database), the project's purpose was to provide all those involved in health care evaluation with a comprehensive and unique source of information on PRO and HRQOL measures available through the Internet. PROQOLID currently describes more than 470 PRO instruments in a structured format. It is available in two levels, non-subscribers and subscribers, at . The first level is free of charge and contains 14 categories of basic useful information on the instruments (e.g. author, objective, original language, list of existing translations, etc.). The second level provides significantly more information about the instruments. It includes review copies of over 350 original instruments, 120 user manuals and 350 translations. Most are available in PDF format. This level is only accessible to annual subscribers. PROQOLID is updated in close collaboration with the instruments' authors on a regular basis. Fifty or more new instruments are added to the database annually. Today, all of the major pharmaceutical companies, prestigious institutions (such as the FDA, the NIH's National Cancer Institute, the U.S. Veterans Administration), dozens of universities, public institutions and researchers subscribe to PROQOLID on a yearly basis. More than 800 users per day routinely visit the database. PMID:15755325

  3. Advancing the efficiency and efficacy of patient reported outcomes with multivariate computer adaptive testing.

    PubMed

    Morris, Scott; Bass, Mike; Lee, Mirinae; Neapolitan, Richard E

    2017-09-01

    The Patient Reported Outcomes Measurement Information System (PROMIS) initiative developed an array of patient reported outcome (PRO) measures. To reduce the number of questions administered, PROMIS utilizes unidimensional item response theory and unidimensional computer adaptive testing (UCAT), which means a separate set of questions is administered for each measured trait. Multidimensional item response theory (MIRT) and multidimensional computer adaptive testing (MCAT) simultaneously assess correlated traits. The objective was to investigate the extent to which MCAT reduces patient burden relative to UCAT in the case of PROs. One MIRT and 3 unidimensional item response theory models were developed using the related traits anxiety, depression, and anger. Using these models, MCAT and UCAT performance was compared with simulated individuals. Surprisingly, the root mean squared error for both methods increased with the number of items. These results were driven by large errors for individuals with low trait levels. A second analysis focused on individuals aligned with item content. For these individuals, both MCAT and UCAT accuracies improved with additional items. Furthermore, MCAT reduced the test length by 50%. For the PROMIS Emotional Distress banks, neither UCAT nor MCAT provided accurate estimates for individuals at low trait levels. Because the items in these banks were designed to detect clinical levels of distress, there is little information for individuals with low trait values. However, trait estimates for individuals targeted by the banks were accurate and MCAT asked substantially fewer questions. By reducing the number of items administered, MCAT can allow clinicians and researchers to assess a wider range of PROs with less patient burden.

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

    PubMed

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

    2016-12-06

    To determine whether patients could self-report physical and mental health assessments in the waiting room and whether these assessments would be associated with modified Rankin Scale (mRS) and Quality of Life in Epilepsy (QOLIE-10) scores. We offered iPad-based surveys to consecutive adult neurology patients at check-in to collect patient-reported outcome measures (PROMs). We collected demographic and clinical data on 6,075 patients through survey or administrative claims and PROMs from participating patients. We compared demographic characteristics of participants and nonparticipants and tested associations between physical and mental health scores and mRS and QOLIE-10. Of 6,075 patients seen by neurologists during the study period, 2,992 (49.3%) participated in the survey. Compared to nonparticipating patients, participating patients more often were privately insured (53.5% vs 42.7%, p < 0.01), married (51.5% vs 47.9%, p < 0.01), and seen in general neurology (nonsubspecialty) clinics (53.1% vs 46.6%, p < 0.01) and more likely to report English as their preferred language (50.1% vs 38.4%, p < 0.01). Participating patients had a mean physical health T score of 28.7 (SD 15) and mental health T score of 33 (SD 15), which were 3 and 2 SD worse than the average for the US general population, respectively. Mean T scores in every category of the mRS were different from every other category (n = 232, p < 0.01). Patient Reported Outcomes Measurement Information System-10 T scores were linearly associated with QOLIE-10 scores (n = 202, p < 0.01) CONCLUSIONS: Systematic digital collection of PROMs is feasible. Differences among survey participants and nonparticipants highlight the need to develop multilingual measurement tools that may improve collection from vulnerable populations. © 2016 American Academy of Neurology.

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

    PubMed Central

    2016-01-01

    The intersection of widespread mobile adoption, cloud computing and healthcare will enable patient-reported outcomes to be used to personalize care, draw insights and shorten the cycle from research to clinical implementation. Today, patient-reported outcomes are largely collected as part of a regulatory shift to value-based or bundled care. When patients are able to record their experiences in real-time and combine them with passive data collection from sensors and mobile devices, this information can inform better care for each patient and contribute to the growing body of health data that can be used to draw insights for all patients. This paper explores the current limitations of patient reported outcomes and how mobile health and big data analysis unlocks their potential as a valuable tool to deliver care. PMID:28293580

  6. Preoperative Joint Space Width Predicts Patient-Reported Outcomes After Total Hip Arthroplasty in Young Patients.

    PubMed

    Stambough, Jeffrey B; Xiong, Ao; Baca, Geneva R; Wu, Ningying; Callaghan, John J; Clohisy, John C

    2016-02-01

    In a new health care economy, there is an emerging need to understand and quantify predictors of total hip arthroplasty (THA) outcomes. We investigated the association between preoperative radiographic disease (as measured quantitatively by joint space width [JSW]) and patient-reported function, activity, pain, and quality of life after THA. We retrospectively analyzed 146 patients (146 hips) 55 years or younger with a diagnosis of osteoarthritis who underwent cementless THA between January 2009 and December 2010. Preoperative pelvic radiographs were measured by 1 author blinded to clinical outcomes to establish JSW, defined as the shortest distance between the femoral head margin and the superolateral weight-bearing portion of the acetabulum. The JSW value was treated as a continuous variable when applied to statistical modeling. The relationship between the JSW and the improvement of clinical outcome was examined via a general linear modeling approach with adjustments for patients' age, body mass index, and sex. We identified an inverse relationship between preoperative JSW and improvements in functional, activity, pain, and quality of life. We found that, as JSW decreased by 1 mm, the outcome measure improvements were modified Harris Hip Score of 6.3 (p<0.001); SF-12 physical: 2.1 (p=0.027); WOMAC-pain: 4.8 (p=0.01); and UCLA Activity: 0.44 (p=0.02). Our results demonstrate that patients with greater preoperative joint space have less predictable improvement in terms of function, pain relief, and activity. These findings suggest that THA in young patients with a JSW less than 1.5 to 2 mm provides more predictable improvements in pain and functional outcomes. Copyright © 2016 Elsevier Inc. All rights reserved.

  7. The Effect of Physician Continuing Medical Education on Patient-Reported Outcomes for Identifying and Optimally Managing Obstructive Sleep Apnea

    PubMed Central

    Johnson, Sara S.; Castle, Patricia H.; Van Marter, Deborah; Roc, Anne; Neubauer, David; Auerbach, Sanford; DeAguiar, Emma

    2015-01-01

    Study Objective: To evaluate the effect of continuing medical education (CME) activities on patient reported outcomes with regard to (1) screening for excessive sleepiness (ES) and obstructive sleep apnea (OSA) and (2) appropriate referral and treatment. Methods: A total of 725 patients were recruited from 75 providers who either participated or did not participate in Transtheoretical Model (TTM)-based OSA CME activities. Patient reported outcomes from participating (n = 36) and non-participating providers (n = 39) were compared using generalized estimating equations examining random effects of provider as unit of assignment. Results: Patients' reports demonstrate that participating physicians were 1.7 times more likely to initiate discussion of sleep problems than non-participating physicians (t1,411 = 3.71, p = 0.05) and 2.25–2.86 times more likely to administer validated measures for OSA (Epworth Sleepiness Scale and STOP-BANG). Patient reports also indicated that participating clinicians (79.9%) were significantly more likely to recommend seeing a sleep specialist compared to non-participating clinicians (60.7%; t1,348 = 9.1, p < 0.01, OR = 2.6). Furthermore, while 89.4% of participating clinicians recommended a sleep study, only 73.2% of the non-participating physicians recommended one (t1,363 = 11.46, p < 0.001, OR = 3.1). Conclusions: Participation in TTM-based OSA CME activities was associated with improved patient reported outcomes compared to the non-participating clinicians. Citation: Johnson SS, Castle PH, Van Marter D, Roc A, Neubauer D, Auerbach S, DeAguiar E. The effect of physician continuing medical education on patient-reported outcomes for identifying and optimally managing obstructive sleep apnea. J Clin Sleep Med 2015;11(3):197–204. PMID:25845903

  8. Multicenter Analysis of Patient Reported Outcomes Following Artificial Urinary Sphincter Placement for Male Stress Urinary Incontinence.

    PubMed

    Wingate, Jonathan T; Erickson, Bradley A; Murphy, Gregory; Smith, Thomas G; Breyer, Benjamin N; Voelzke, Bryan B

    2017-09-27

    Patient-centered data regarding functional and quality of life improvements after AUS placement is lacking. We analyzed the degree of benefit from AUS placement utilizing the ISI, a validated patient reported outcome measure assessing severity and bother of urinary incontinence and the IIQ-7, a validated patient reported outcome measure assessing the impact and emotional distress of urinary incontinence. We performed a retrospective review from four participating centers in the Trauma and Urologic Reconstruction Network of Surgeons. Data were available for 51 and 45 patients who underwent AUS placement and had preoperative and postoperative ISI and IIQ-7 data, respectively. Mean age was 64.8 years. The median time from surgery to follow-up questionnaires was 8.5 months. Among the ISI, the median preoperative severity and bother scores were 24 (IQR 20, 28.5) and 6 (IQR 4, 7), respectively. The median postoperative severity and bother scores were 10 (IQR 4.5, 17) and 1 (IQR 0, 3), respectively. Improvement for each item of the ISI questionnaire was statistically significant.Among the IIQ-7, the median preoperative impact and distress scores were 9 (IQR 6, 13) and 4 (2, 6), respectively. The median postoperative impact and distress scores were 3 (IQR 0, 7) and 0 (IQR 0, 3). Improvement for each item of the IIQ-7 questionnaire was statistically significant. AUS implantation significantly reduces the severity and bother of stress urinary incontinence symptoms. Longer follow up and development of a PROM targeting male SUI is needed. Copyright © 2017 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

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

    PubMed

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

    2015-01-01

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

  10. Measuring Outcomes.

    ERIC Educational Resources Information Center

    Kirschenmann, Sandy; Lane, Theodore

    2001-01-01

    Describes the California Community Colleges' goal to advance the state's economic growth through quality economic development programs. Discusses the importance of assessment and presents the results of an outcome evaluation, stating that California will collect $1.42 in taxes over the next 10 years for every dollar it spent on economic…

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

    PubMed Central

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

    2013-01-01

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

  12. Advantages and Psychometric Validation of Proximal Intensive Assessments of Patient Reported Outcomes Collected in Daily Life

    PubMed Central

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

    2016-01-01

    Objectives Ambulatory assessment data collection methods are increasingly used to study behavior, experiences, and patient reported outcomes (PROs) such as emotions, cognitions, and symptoms in clinical samples. Data collected close in time at frequent and fixed intervals can assess PROs that are discrete or changing rapidly and provide information about temporal dynamics or mechanisms of change in clinical samples and individuals, but clinical researchers have not yet routinely and systematically investigated the reliability and validity of such measures or their potential added value over conventional measures. The present study provides a comprehensive, systematic evaluation of the psychometrics of several Proximal Intensive Assessment (PIA) measures in a clinical sample and investigates whether PIA appears to assess meaningful differences in phenomena over time. Methods Data was collected on a variety of psychopathology constructs on handheld devices every 4 hours for 7 days from 62 adults recently exposed to traumatic injury of themselves or a family member. Data was also collected on standard self-report measures of the same constructs at the time of enrollment, one week after enrollment, and two months after injury. Results For all measure scores, results showed good internal consistency across items and within persons over time, provided evidence of convergent, divergent, and construct validity, and showed significant between and within-subject variability. Conclusions Results indicate that PIA measures can provide valid measurement of psychopathology in a clinical sample. PIA may be useful to study mechanisms of change in clinical contexts, identify targets for change, and gauge treatment progress. PMID:26567018

  13. Quality of life among patients after bilateral prophylactic mastectomy: A systematic review of patient reported outcomes

    PubMed Central

    Razdan, Shantanu N.; Patel, Vishal; Jewell, Sarah; McCarthy, Colleen M.

    2016-01-01

    Purpose Bilateral prophylactic mastectomy (BPM) is effective in reducing the risk of breast cancer in women with a well-defined family history of breast cancer or in women with BRCA 1 or 2 mutations. Evaluating patient-reported outcomes following BPM are thus essential for evaluating success of BPM from patient’s perspective. Our systematic review aimed to: (1) identify studies describing health-related quality of life (HRQOL) in patients following BPM with or without reconstruction; (2) assess the effect of BPM with or without reconstruction on HRQOL; and, (3) identify predictors of HRQOL post BPM. Methods We performed a systematic review of literature using the PRISMA guidelines. PubMed, Embase, PsycINFO, Web of Science, Scopus and Cochrane databases were searched. Results The initial search resulted in 1082 studies; 22 of these studies fulfilled our inclusion criteria. Post BPM, patients are satisfied with the outcomes and report high psychosocial well-being and positive body image. Sexual well-being and somatosensory function are most negatively affected. Vulnerability, psychological distress and preoperative cancer distress are significant negative predictors of quality of life and body image post BPM. Conclusion There is a paucity of high quality data on outcomes of different HRQOL domains post BPM. Future studies should strive to use validated and breast-specific PRO instruments for measuring HRQOL. This will facilitate shared decision-making by enabling surgeons to provide evidence-based answers to women contemplating BPM. PMID:26577764

  14. Patient-reported outcomes in acute myeloid leukemia: Where are we now?

    PubMed

    Buckley, Sarah A; Kirtane, Kedar; Walter, Roland B; Lee, Stephanie J; Lyman, Gary H

    2017-09-01

    Outcomes for acute myeloid leukemia remain poor, and treatment decisions must consider not just quantity, but also quality of life (QOL). We conducted a systematic review of studies in patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that incorporated patient-reported outcome (PRO) measures. PubMed and PsycINFO were searched for articles published from January 2000 through June 2016. Forty-one were relevant for our review with more published in recent years. There was considerable inter-study heterogeneity in which instruments were used, and many studies employed multiple (often overlapping) instruments. Longitudinal studies in particular suffered from both high attrition rates due to disease-related mortality as well as waning compliance with questionnaire completion. There remain significant challenges to incorporation of PROs into leukemia trials. Despite these limitations, however, well-implemented PROs can provide important information beyond objective response outcomes and highlight areas of focus for clinicians caring for patients and for future research endeavors. Copyright © 2017 Elsevier Ltd. All rights reserved.

  15. 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

  16. Defining a Research Agenda for Patient-Reported Outcomes in Surgery: A Delphi Survey of Stakeholders

    PubMed Central

    Pezold, Michael L.; Pusic, Andrea L.; Cohen, Wess A.; Hollenberg, James P.; Butt, Zeeshan; Flum, David R.; Temple, Larissa K.

    2016-01-01

    Background Identifying timely and important research questions using relevant patient-reported outcomes (PROs) in surgery remains paramount in the current medical climate. The inaugural Patient-Reported Outcomes in Surgery Conference brought together stakeholders in PROs research in surgery, with the aim of creating a research agenda to help determine future directions and advance cross-disciplinary collaboration. Study Design An iterative Web-based interface was used to create a modified Delphi survey. Participation was limited to conference registrants, which included surgeons, PROs researchers, payers, and other stakeholders. In the first round, research items were generated from qualitative review of responses to open-ended prompts. In the second round, items were ranked using a 5-point Likert scale; attendees were also asked to submit any new items. In the final round, the top 30 items and newly submitted items were redistributed for final ranking using a 3-point Likert scale. The top 20 items by mean rating were selected for the research agenda. Results In round one, participants submitted 459 items, which were reduced to 53 distinct items within seven themes of PROs research. A research agenda was formulated after two successive rounds of ranking. The research agenda identified three themes important for future PROs research in surgery: (1) PROs in the decision-making process, (2) integrating PROs into the EHR and, (3) measuring quality in surgery with PROs. Conclusions The PROS Conference research agenda was created using a modified Delphi survey of stakeholders that will help researchers, surgeons, and funders identify crucial areas of future PROs research in surgery. PMID:27437666

  17. Favorable patient reported outcomes after penile plication for wide array of peyronie disease abnormalities.

    PubMed

    Hudak, Steven J; Morey, Allen F; Adibi, Mehrad; Bagrodia, Aditya

    2013-03-01

    We present patient reported outcomes from our 5-year experience using penile plication to correct a wide variety of Peyronie disease malformations. We reviewed the records of all men who underwent penile plication for Peyronie disease, as performed by one of us (AFM). All patients were treated with tunical plication without penile degloving via a 2 cm longitudinal penile incision regardless of curvature severity or erectile function. A concomitant inflatable penile prosthesis was placed in men with refractory erectile dysfunction. A questionnaire was administered to assess the patient perception of postoperative penile curvature, length, rigidity and adequacy for intercourse. Of 154 treated patients 78 (51%) and 65 (42%) had simple (less than 60 degrees) and complex (biplanar curvature, or curvature 60 degrees or greater) malformation, respectively, while 11 (7%) underwent plication plus inflatable penile prosthesis placement. A total of 132 patients responded to the questionnaire a mean 14 months after surgery. Overall, 96% of patients reported curvature improvement after penile plication, 93% reported erection adequate for sexual intercourse and 95% considered that the overall condition improved after surgery. Despite a significant difference in the number of plication sutures (mean 10 vs 7) and curvature angle correction (mean 57 vs 30 degrees, each p <0.005), self-reported outcomes of complex cases were equivalent to those of simple cases. While 84% of patients had no measureable decrease in stretched penile length, 103 of 154 (78%) reported a perceived penile length reduction after surgery. Penile plication without degloving is effective for correcting a wide variety of Peyronie disease malformations. It can be safely combined with inflatable penile prosthesis placement. Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  18. The Cambridge Breast Intensity-modulated Radiotherapy Trial: Comparison of Clinician- versus Patient-reported Outcomes.

    PubMed

    Mukesh, M B; Qian, W; Wah Hak, C C; Wilkinson, J S; Barnett, G C; Moody, A M; Wilson, C; Coles, C E

    2016-06-01

    Breast radiotherapy-associated toxicity is often reported using clinical and photographic assessments. The addition of patient-reported outcome measures (PROMs) is becoming more common. This study investigated the concordance between clinician- and patient-reported outcomes. The Cambridge Breast Intensity-modulated Radiotherapy (IMRT) trial prospectively collected data on clinician assessment and PROMs at 2 and 5 years after breast radiotherapy. Clinician assessment included physical examination and photographic assessment. PROMs included European Organization for Research and Treatment of Cancer (EORTC) BR23 questionnaire and four breast radiotherapy-specific questions. The correlation between patient and clinician scores were analysed on an independent patient basis using percentage agreement, Cohen's kappa coefficient (k) and Bowker's test of symmetry. The analysis was repeated after stratifying patients based on age, baseline Hospital Anxiety and Depression Score (HADS) and baseline body image score. At 2 and 5 years, a weak level of concordance was seen between the clinician-based assessment and PROMS for all the five toxicity end points (k = 0.05-0.21), with individual patient-based agreement of 32.9-78.3% and a highly discordant Bowker's test of symmetry (P < 0.001). The most frequently reported moderate-severe toxicity by patients was change in breast appearance (14% at both 2 and 5 years), whereas it was breast induration (36% and 25% at 2 and 5 years, respectively) by the clinicians. The lack of concordance was not affected by patient's age, baseline HADS and baseline body image score. This study found that moderate-severe toxicity reported by patients is low and the overall concordance between clinicians and patients is low. This could be due to methodological limitations or alternatively reflects the subjective nature of PROMs. Incorporation of a patient's perception on treatment-related toxicity will have important implications for treatment

  19. Ability to perform a single heel-rise is significantly related to patient-reported outcome after Achilles tendon rupture.

    PubMed

    Olsson, N; Karlsson, J; Eriksson, B I; Brorsson, A; Lundberg, M; Silbernagel, K G

    2014-02-01

    This study evaluated the short-term recovery of function after an acute Achilles tendon rupture, measured by a single-legged heel-rise test, with main emphasis on the relation to the patient-reported outcomes and fear of physical activity and movement (kinesiophobia). Eighty-one patients treated surgically or non-surgically with early active rehabilitation after Achilles tendon rupture were included in the study. Patient's ability to perform a single-legged heel-rise, physical activity level, patient-reported symptoms, general health, and kinesiophobia was evaluated 12 weeks after the injury. The heel-rise test showed that 40 out of 81 (49%) patients were unable to perform a single heel-rise 12 weeks after the injury. We found that patients who were able to perform a heel-rise were significantly younger, more often of male gender, reported a lesser degree of symptoms, and also had a higher degree of physical activity at 12 weeks. There was also a significant negative correlation between kinesiophobia and all the patient-reported outcomes and the physical activity level. The heel-rise ability appears to be an important early achievement and reflects the general level of healing, which influences patient-reported outcome and physical activity. Future treatment protocols focusing on regaining strength early after the injury therefore seem to be of great importance. Kinesiophobia needs to be addressed early during the rehabilitation process. © 2012 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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

    PubMed

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

    2016-08-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2017-10-10

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