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COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study.

ABSTRACT: BACKGROUND:Content validity is the most important measurement property of a patient-reported outcome measure (PROM) and the most challenging to assess. Our aims were to: (1) develop standards for evaluating the quality of PROM development; (2) update the original COSMIN standards for assessing the quality of content validity studies of PROMs; (3) develop criteria for what constitutes good content validity of PROMs, and (4) develop a rating system for summarizing the evidence on a PROM's content validity and grading the quality of the evidence in systematic reviews of PROMs. METHODS:An online 4-round Delphi study was performed among 159 experts from 21 countries. Panelists rated the degree to which they (dis)agreed to proposed standards, criteria, and rating issues on 5-point rating scales ('strongly disagree' to 'strongly agree'), and provided arguments for their ratings. RESULTS:Discussion focused on sample size requirements, recording and field notes, transcribing cognitive interviews, and data coding. After four rounds, the required 67% consensus was reached on all standards, criteria, and rating issues. After pilot-testing, the steering committee made some final changes. Ten criteria for good content validity were defined regarding item relevance, appropriateness of response options and recall period, comprehensiveness, and comprehensibility of the PROM. DISCUSSION:The consensus-based COSMIN methodology for content validity is more detailed, standardized, and transparent than earlier published guidelines, including the previous COSMIN standards. This methodology can contribute to the selection and use of high-quality PROMs in research and clinical practice.

SUBMITTER: Terwee CB

PROVIDER: S-EPMC5891557 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study.

Terwee C B CB Prinsen C A C CAC Chiarotto A A Westerman M J MJ Patrick D L DL Alonso J J Bouter L M LM de Vet H C W HCW Mokkink L B LB

Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation 20180317 5

<h4>Background</h4>Content validity is the most important measurement property of a patient-reported outcome measure (PROM) and the most challenging to assess. Our aims were to: (1) develop standards for evaluating the quality of PROM development; (2) update the original COSMIN standards for assessing the quality of content validity studies of PROMs; (3) develop criteria for what constitutes good content validity of PROMs, and (4) develop a rating system for summarizing the evidence on a PROM's ...[more]

PMID: 29550964

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Project description:ImportanceChemotherapy-induced peripheral neuropathy (CIPN) is a substantial adverse effect of anticancer treatments. As such, the assessment of CIPN remains critically important in both research and clinic settings.ObjectiveTo compare the validity of various patient-reported outcome measures (PROMs) with neurophysiological and sensory functional measures as the optimal method of CIPN assessment.Design, setting, and participantsThis cohort study evaluated participants treated with neurotoxic chemotherapy across 2 cohorts using a dual-study design. Participants commencing treatment were assessed prospectively at beginning of neurotoxic treatment, midtreatment, and at the end of treatment. Participants who completed treatment up to 5 years prior were assessed cross-sectionally and completed a single assessment time point. Participants were recruited from oncology centers in Australia from August 2015 to November 2022. Data analysis occurred from February to November 2023.ExposuresNeurotoxic cancer treatment including taxanes, platinums, vinca-alkaloids, proteasome inhibitors, and thalidomide.Main outcomes and measuresCIPN was assessed via PROMs (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC-CIPN20], Functional Assessment of Cancer Therapy/Gynecological Cancer Group Neurotoxicity Questionnaire (FACT/GOG-Ntx), and the patient-reported outcomes version of the Common Terminology Criteria for Adverse Events [PRO-CTCAE]), neurological and neurophysiological assessment (Total Neuropathy Score and sural and tibial compound nerve amplitudes), and sensory measures (Grating orientation, Von Frey monofilament, and 2-point discrimination tasks). Core measurement properties of CIPN outcome measures were evaluated. Convergent and known-groups validity was assessed cross-sectionally following treatment completion, and responsiveness was evaluated prospectively during treatment. Neurological, neurophysiological, and sensory outcome measure scores were compared between those who reported high and low levels of CIPN symptoms using linear regressions.ResultsA total of 1033 participants (median [IQR] age, 61 [50-59] years; 676 female [65.4%]) were recruited to this study, incorporating 1623 assessments. PROMs demonstrated best ability to accurately assess CIPN (convergent validity), especially the PRO-CTCAE composite score (r = 0.85; P < .001) and EORTC-CIPN20 (r = 0.79; P < .001). PROMS also demonstrated the best ability to discriminate between CIPN severity (known-groups validity) and to detect changes at onset of CIPN development (responsiveness), especially for EORTC-CIPN20 (d = 0.67; 95% CI, 0.52-0.83), FACT/GOG-Ntx (d = 0.65; 95% CI, 0.49-0.81) and the PRO-CTCAE (d = 0.83; 95% CI, 0.64-1.02). Other measures did not achieve threshold for convergent validity (α < 0.7). Neurophysiological and sensory measures did not demonstrate acceptable responsiveness. In regression models, neurological, neurophysiological, and sensory outcome measures were significantly impaired in participants who reported high levels of CIPN symptoms compared with those who reported low levels of CIPN symptoms.Conclusions and relevanceIn this cohort study of 1033 cancer patients, PROMs were the only measures to satisfy all 3 core measurement property criteria (convergent validity, known-groups validity, and responsiveness). These findings suggest that adoption of PROMs in clinical practice can equip clinicians with valuable information in assessing CIPN morbidity.

Project description:BackgroundDysphagia (swallowing difficulty) is one of the most common and debilitating sequelae of head and neck cancer (HNC). Patient-reported outcome measures (PROMs) are a fundamental component of dysphagia outcomes evaluation, as they inform treatment consequences that cannot be captured by objective clinician measures. Many PROMs for dysphagia in HNC are available, but their validity is unclear. As a consequence, the selection of the most appropriate PROM for dysphagia in HNC is complex and often based on the clinician's personal preferences, rather than on valid psychometric properties. This protocol describes a systematic review aiming at (1) identifying PROMs specific to dysphagia symptoms, swallowing functional status, swallowing-related health status, and swallowing-related quality of life in HNC, (2) mapping them to our conceptual framework of dysphagia-related PROs, and (3) appraising their psychometric properties using the Consensus Based Standards for the Selection of Health Measurement Instrument (COSMIN) methodology.MethodsSix electronic databases will be searched from inception to December 2020 for all primary studies in any language and design detailing PROM development, reliability, validity, feasibility, interpretability, and/or cross-cultural adaptation. Eligibility criteria will target PROMs for patients with HNC (≥ 90% of the study sample) with ≥ 20% of their items pertaining to swallowing. Two independent raters will screen abstract and full texts and a third rater will resolve discrepancies. Data will be extracted on study, sample and PROM characteristics, and results of psychometric testing. PROMs will be mapped to our conceptual framework. The methodological quality of included PROMs and their psychometric properties will be appraised using the COSMIN risk of bias checklist and evidence will be summarized using a modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.DiscussionThis systematic review will provide a summary of existing dysphagia-related PROMs for people with HNC and a comprehensive account of their psychometric properties. We will provide recommendations on PROMs selection which will aid healthcare professionals to the most appropriate PROM based on its validity, reliability, feasibility, interpretability and suitability for clinical and research settings. Further recommendations will be made on areas of measurement property requiring further testing.Systematic review registrationPROSPERO registration ID: CRD42021237877.

Project description:BackgroundPatient-reported outcome measures (PROMs) are questionnaires that measure patient outcomes related to quality of life, health, and functioning, and are increasingly used to assess important outcomes from the patient's perspective. For PROMs to contribute to better health and better care, it is vital that their content validity be adequate. This requires patient involvement in various steps of PROM development. PROM developers not only recognize the benefits of patient involvement but also report difficulties in recruiting patients and experience patient involvement as time-consuming, logistically challenging, and expensive.ObjectiveThis study seeks to explore different strategies for disclosing the experiential knowledge of patients, namely through analyzing patient stories on the web and social media. The research questions are as follows: (1) how do bloggers living with a disease experience their health-related quality of life? (2) How are these experiences reflected in the domains and items of PROMs related to their disease?MethodsFirst, a qualitative analysis of blogs written by patients was performed. Second, subthemes and underlying codes resulting from this qualitative analysis were systematically compared with the domains and items in PROMs for the respective diseases that the bloggers write about. Blogs were identified via the Google search engine between December 2019 and May 2021.ResultsBloggers describe a wide range of experiences regarding their physical functioning and health; mental well-being; social network and support; daily life, education, work, and leisure; coping; and self-management. Bloggers also write about their positive and negative experiences with health care delivery, the organization of health care, and health care professionals. In general, patients' experiences as described in blogs were reflected in the domains and items of the PROMs related to their disease. However, except for diabetes mellitus, in all the sets of PROMs, potentially missing topics could be identified. Similarly, with the exception of Parkinson disease, all PROMs address issues that patients did not write about in their blogs and that might therefore be redundant.ConclusionsWeb-based patient stories in the form of blogs reveal how people living with a certain disease experience their health-related quality of life. These stories enable analyses of patients' experiences that can be used to assess the content validity of PROMs. This can be a useful step for researchers who are looking for sets of measuring instruments that match their purposes.

Project description:Background and objectiveSeveral medication adherence patient-reported outcome measures (MA-PROMs) are available for use in patients with cardiovascular disease (CVD); however, little evidence is available on the most suitable MA-PROM to measure medication adherence in patients with CVD. The aim of this systematic review is to synthesise the measurement properties of MA-PROMs for patients with CVD and identify the most suitable MA-PROM for use in clinical practice or future research in patients with CVD.MethodsAn electronic search of nine databases (PubMed, MEDLINE, CINAHL, ProQuest Health and Medicine, Cochrane Library, PsychInfo, Scopus, Embase, and Web of Science) was conducted to identify studies that have reported on at least one of the measurement properties of MA-PROMs in patients with CVD. The methodological quality of the studies included in the systematic review was evaluated using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist.ResultsA total of 40 MA-PROMs were identified in the 84 included studies. This review found there is a lack of moderate-to-high quality evidence of sufficient content validity for all MA-PROMs for patients with CVDs. Only eight MA-PROMs were classified in COSMIN recommendation category A. They exhibited sufficient content validity with very low-quality evidence, and moderate-to-high quality evidence for sufficient internal consistency. The 28 MA-PROMs that meet the requirements for COSMIN recommendation category 'B' require further validation studies. Four MA-PROMs including Hill-Bone Compliance Medication Scale (HBMS), the five-item Medication Adherence Report Scale (MARS-5), Maastricht Utrecht Adherence in Hypertension (MUAH), and MUAH-16 have insufficient results with high quality evidence for at least one measurement property and consequently are not recommended for use in patients with CVD. Two MA-PROMs (Adherence to Refills and Medications Scale [ARMS] and ARMS-7) are comprehensive and have moderate to high quality evidence for four sufficient measurement properties.ConclusionFrom the eight MA-PROMs in COSMIN recommendation category A, ARMS and ARMS-7 were selected as the most suitable MA-PROMs for use in patients with CVD. They are the most comprehensive with be best quality evidence to support their use in clinical practice and research.

Project description:BackgroundResponsiveness, or sensitivity to clinical change, is important when selecting patient-reported outcome measures (PROMs) for research and clinical applications. This study compares responsiveness of PROMs used in chronic rhinosinusitis (CRS) to inform the future development of a highly responsive instrument that accurately portrays CRS patients' symptom experiences.MethodsAdult CRS patients initiating medical therapy (MT; n = 143) or undergoing endoscopic sinus surgery after failing MT (ESS; n = 123) completed the 22-item Sino-Nasal Outcome Test (SNOT-22), European Position Statement on Rhinosinusitis (EPOS) visual analog scale (VAS), and 29-item Patient-Reported Outcomes Measurement Information System (PROMIS-29) at baseline and 3 months after treatment. Cohen's d and paired t statistics were used to evaluate the responsiveness of each measure.ResultsFifty-two (36.4%) subjects and 42 (34.1%) subjects in the MT and ESS groups, respectively, completed baseline and 3-month questionnaires. Subjects with and without 3-month data were similar with respect to baseline demographics, VAS scores, and SNOT-22 scores (p > 0.05). In MT patients, CRS-specific measures, like VAS (d = -0.58, p < 0.01; t = -1.81, p > 0.05) and SNOT-22 (d = -0.70, p < 0.01; t = -3.29, p < 0.05) scores, were more responsive than PROMIS-29 general health domains (p > 0.05 for Cohen's d). In ESS patients, VAS (d = -1.97; t = -9.63, both p < 0.01) and SNOT-22 (d = -1.56; t = -9.99, both p < 0.01) scores were similarly more responsive, although changes in PROMIS-29 domains of Fatigue (d = -0.82, p = 0.01; t = -4.63, p < 0.01), Sleep Disturbance (d = -0.83; t = -3.77, both p < 0.01), and Pain Intensity (d = -1.0; t = -5.67, both p < 0.01) were significant. All 22 individual SNOT-22 items differed significantly after surgery, whereas only 8 items were consistently responsive after MT.ConclusionsFor both MT and ESS patients, CRS-specific PROMs are more responsive to posttreatment clinical changes than general health measures. Still, the SNOT-22 contains items that likely decrease its overall responsiveness. Our findings also indicate that existing PROMs had a greater response to ESS than MT.

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COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study.

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COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study.

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