COSMIN guideline for systematic reviews of patient-reported outcome measures

Abstract

PurposeSystematic reviews of patient-reported outcome measures (PROMs) differ from reviews of interventions and diagnostic test accuracy studies and are complex. In fact, conducting a review of one or more PROMs comprises of multiple reviews (i.e., one review for each measurement property of each PROM). In the absence of guidance specifically designed for reviews on measurement properties, our aim was to develop a guideline for conducting systematic reviews of PROMs.MethodsBased on literature reviews and expert opinions, and in concordance with existing guidelines, the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) steering committee developed a guideline for systematic reviews of PROMs.ResultsA consecutive ten-step procedure for conducting a systematic review of PROMs is proposed. Steps 1–4 concern preparing and performing the literature search, and selecting relevant studies. Steps 5–8 concern the evaluation of the quality of the eligible studies, the measurement properties, and the interpretability and feasibility aspects. Steps 9 and 10 concern formulating recommendations and reporting the systematic review.ConclusionsThe COSMIN guideline for systematic reviews of PROMs includes methodology to combine the methodological quality of studies on measurement properties with the quality of the PROM itself (i.e., its measurement properties). This enables reviewers to draw transparent conclusions and making evidence-based recommendations on the quality of PROMs, and supports the evidence-based selection of PROMs for use in research and in clinical practice.

Convergent Validity and Responsiveness of the SULCS

“…While this study is in line with COSMIN guidelines, 13 it was not powered a-priori for the analyses reported here, and the modest sample size may limit the conclusions that can be made. Only 20% of the participants were >15 months post-stroke by the end of the study; therefore, the findings here may not be generalizable to patients who are beyond that timeframe.…”

A systematic review of the measurement properties of the European Organisation for Research and Treatment of Cancer In-patient Satisfaction with Care Questionnaire, the EORTC IN-PATSAT32

“…Studies were included that reported original data on cancer patients, and on at least one of the following measurement properties of the IN-PATSAT32 as defined by the COSMIN taxonomy [10–13]: internal consistency, reliability, measurement error, structural validity, hypothesis testing (for construct validity), criterion validity, cross-cultural validity, and responsiveness. Validation studies on other PROMs, which also reported original data on the IN-PATSAT32, were included.…”

“…Second, criteria for good measurement properties were applied to the results of the included studies, following the COSMIN guidelines for systematic reviews of PROMs [13]. Each measurement property in each individual study was rated as sufficient (+), insufficient (−), or indeterminate (?…”

“…Third, we used the modified GRADE approach [13] to rate the quality of the evidence available for the measurement properties of the IN-PATSAT32. This approach takes into account (i) methodological quality, (ii) directness of evidence, (iii) inconsistency of results, and (iv) precision of evidence.…”

“…Evaluating measurement properties requires weighing many variables on both the level of the study and on the level of the PROM. Therefore, the current study used the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria for assessing measurement properties of PROMs [10–13]. …”