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      Patient-reported outcome measures in functional dyspepsia: a systematic review and COSMIN analysis

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          Abstract

          Background

          Functional dyspepsia (FD) as a type of disorders of brain-gut interaction (DBGI), patient self-reporting of its symptoms becomes an important component of clinical outcome assessment. We performed a systematic review using Consensus Based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines to identify the best available patient-reported outcome measure (PROM) of FD.

          Methods

          The study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). We searched four databases with no date limit, looking for previously confirmed PROMs for evaluating FD symptoms. An overall rating was then assigned based upon COSMIN guidelines, and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was used to assess the level of evidence for psychometric properties of included PROMs.

          Results

          Thirty articles covering outcome indicators of 24 patient reports were included. The Leuven Postprandial Distress Scale (LPDS) showed adequate content validity and moderate quality evidence of adequate internal consistency to generate an A recommendation.

          Conclusion

          LPDS is currently the most recommended PROM for patient self-reported FD symptoms. However, it fails to assess two important areas of cross-cultural validity/ measurement invariance and measurement error. Future research can be continuously improved on this basis.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s12876-023-02935-9

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          Quality criteria were proposed for measurement properties of health status questionnaires.

          Caroline Terwee, Sandra D M Bot, Michael de Boer … (2007)
          Recently, an increasing number of systematic reviews have been published in which the measurement properties of health status questionnaires are compared. For a meaningful comparison, quality criteria for measurement properties are needed. Our aim was to develop quality criteria for design, methods, and outcomes of studies on the development and evaluation of health status questionnaires. Quality criteria for content validity, internal consistency, criterion validity, construct validity, reproducibility, longitudinal validity, responsiveness, floor and ceiling effects, and interpretability were derived from existing guidelines and consensus within our research group. For each measurement property a criterion was defined for a positive, negative, or indeterminate rating, depending on the design, methods, and outcomes of the validation study. Our criteria make a substantial contribution toward defining explicit quality criteria for measurement properties of health status questionnaires. Our criteria can be used in systematic reviews of health status questionnaires, to detect shortcomings and gaps in knowledge of measurement properties, and to design validation studies. The future challenge will be to refine and complete the criteria and to reach broad consensus, especially on quality criteria for good measurement properties.
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            COSMIN guideline for systematic reviews of patient-reported outcome measures

            C. A. C. Prinsen, L. Mokkink, L Bouter … (2018)
            Purpose Systematic 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. Methods Based 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. Results A 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. Conclusions The 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.
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              COSMIN Risk of Bias checklist for systematic reviews of Patient-Reported Outcome Measures

              L. Mokkink, H. C. W. de Vet, C. A. C. Prinsen … (2017)
              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. Electronic supplementary material The online version of this article (10.1007/s11136-017-1765-4) contains supplementary material, which is available to authorized users.
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                Author and article information

                Contributors
                Hongling Xiao: dingxiyuan303@sina.com
                Journal
                Journal ID (nlm-ta): BMC Gastroenterol
                Journal ID (iso-abbrev): BMC Gastroenterol
                Title: BMC Gastroenterology
                Publisher: BioMed Central (London )
                ISSN (Electronic): 1471-230X
                Publication date (Electronic): 19 September 2023
                Publication date PMC-release: 19 September 2023
                Publication date Collection: 2023
                Volume: 23
                Electronic Location Identifier: 316
                Affiliations
                [1 ]The School of Graduate, Tianjin University of Traditional Chinese Medicine, ( https://ror.org/05dfcz246) Tianjin, China
                [2 ]GRID grid.412538.9, ISNI 0000 0004 0527 0050, Shanghai Tenth People’s Hospital Chongming Branch, ; Shanghai, China
                [3 ]The School of Nursing, Tianjin University of Traditional Chinese Medicine, ( https://ror.org/05dfcz246) Tianjin, China
                Article
                Publisher ID: 2935
                DOI: 10.1186/s12876-023-02935-9
                PMC ID: 10507973
                PubMed ID: 37726672
                SO-VID: 36c5a55d-5b2a-45f2-9aa2-1e81965e90a5
                Copyright © © BioMed Central Ltd., part of Springer Nature 2023
                License:

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                Date received : 20 February 2023
                Date accepted : 26 August 2023
                Categories
                Subject: Research
                Custom metadata
                issue-copyright-statement © BioMed Central Ltd., part of Springer Nature 2023

                ScienceOpen disciplines: Gastroenterology & Hepatology
                Keywords: functional dyspepsia,dyspepsia,patient-reported outcome measure,measurement properties
                Data availability:
                ScienceOpen disciplines: Gastroenterology & Hepatology
                Keywords: functional dyspepsia, dyspepsia, patient-reported outcome measure, measurement properties

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