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COSMIN Risk of Bias checklist for systematic reviews of Patient-Reported Outcome Measures.

ABSTRACT: PURPOSE:The original COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist was developed to assess the methodological quality of single studies on measurement properties of Patient-Reported Outcome Measures (PROMs). Now it is our aim to adapt the COSMIN checklist and its four-point rating system into a version exclusively for use in systematic reviews of PROMs, aiming to assess risk of bias of studies on measurement properties. METHODS:For each standard (i.e., a design requirement or preferred statistical method), it was discussed within the COSMIN steering committee if and how it should be adapted. The adapted checklist was pilot-tested to strengthen content validity in a systematic review on the quality of PROMs for patients with hand osteoarthritis. RESULTS:Most important changes were the reordering of the measurement properties to be assessed in a systematic review of PROMs; the deletion of standards that concerned reporting issues and standards that not necessarily lead to biased results; the integration of standards on general requirements for studies on item response theory with standards for specific measurement properties; the recommendation to the review team to specify hypotheses for construct validity and responsiveness in advance, and subsequently the removal of the standards about formulating hypotheses; and the change in the labels of the four-point rating system. CONCLUSIONS:The COSMIN Risk of Bias checklist was developed exclusively for use in systematic reviews of PROMs to distinguish this application from other purposes of assessing the methodological quality of studies on measurement properties, such as guidance for designing or reporting a study on the measurement properties.

SUBMITTER: Mokkink LB

PROVIDER: S-EPMC5891552 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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COSMIN Risk of Bias checklist for systematic reviews of Patient-Reported Outcome Measures.

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

Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation 20171219 5

<h4>Purpose</h4>The original COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist was developed to assess the methodological quality of single studies on measurement properties of Patient-Reported Outcome Measures (PROMs). Now it is our aim to adapt the COSMIN checklist and its four-point rating system into a version exclusively for use in systematic reviews of PROMs, aiming to assess risk of bias of studies on measurement properties.<h4>Methods</h4>Fo ...[more]

PMID: 29260445

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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:Patient-reported outcome measures (PROMs) are important tools used to understand patient-focused outcomes from care. Various PROMs have been developed for patients with bladder cancer (BC), although the disease's heterogeneity makes selection difficult. Accurate measurement of health-related quality of life (HRQL) can only be achieved if the PROM chosen is 'fit for purpose' (i.e. psychometrically sound). Systematic reviews of psychometric properties are useful for selecting the best PROM for a specific purpose. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) developed a checklist to improve the selection of health measurement instruments as part of a review process. Our aims were to undertake a systematic review, using the COSMIN criteria, to assess the quality of studies that report the psychometric properties of PROMs used with people with BC and determine the psychometric quality of these PROMs. An electronic search of seven databases including PubMed, MEDLINE and EMBASE (PROSPERO reference CRD42016051974) was undertaken to identify English language publications, published between January 1990 and September 2017 that evaluated psychometric properties of PROMs used in BC research. Two researchers independently screened abstracts and selected full-text papers. Studies were rated on methodological quality using the COSMIN checklist. Overall, 4663 records were screened and 23 studies, reporting outcomes in 3568 patients, were evaluated using the COSMIN checklist. Most PROMs had limited information reported about their psychometric properties. Studies reporting on the Bladder Cancer Index (BCI) and Functional Assessment of Cancer Therapy Vanderbilt Cystectomy Index (FACT-VCI) provided the most detail and these PROMs could be evaluated on the most COSMIN properties. Based on the available evidence, no existing PROM stands out as the most appropriate to measure HRQL in BC populations. This is due to two factors; (i) the heterogeneity of BC and its treatments (ii) no PROM was evaluated on all COSMIN measurement properties due to a lack of validation studies. We suggest future evaluation of generic, cancer generic and BC-specific PROMs to better understand their application with BC populations and propose strategies to help clinicians and researchers.

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.

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COSMIN Risk of Bias checklist for systematic reviews of Patient-Reported Outcome Measures.

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COSMIN Risk of Bias checklist for systematic reviews of Patient-Reported Outcome Measures.

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