A reporting guideline for systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024

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Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024 - Quality of Life Research

Purpose Although comprehensive and widespread guidelines on how to conduct systematic reviews of outcome measurement instruments (OMIs) exist, for example from the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) initiative, key information is often missing in published reports. This article describes the development of an extension of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guideline: PRISMA-COSMIN for OMIs 2024. Methods The development process followed the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines and included a literature search, expert consultations, a Delphi study, a hybrid workgroup meeting, pilot testing, and an end-of-project meeting, with integrated patient/public involvement. Results From the literature and expert consultation, 49 potentially relevant reporting items were identified. Round 1 of the Delphi study was completed by 103 panelists, whereas round 2 and 3 were completed by 78 panelists. After 3 rounds, agreement (≥ 67%) on inclusion and wording was reached for 44 items. Eleven items without consensus for inclusion and/or wording were discussed at a workgroup meeting attended by 24 participants. Agreement was reached for the inclusion and wording of 10 items, and the deletion of 1 item. Pilot testing with 65 authors of OMI systematic reviews further improved the guideline through minor changes in wording and structure, finalized during the end-of-project meeting. The final checklist to facilitate the reporting of full systematic review reports contains 54 (sub)items addressing the review’s title, abstract, plain language summary, open science, introduction, methods, results, and discussion. Thirteen items pertaining to the title and abstract are also included in a separate abstract checklist, guiding authors in reporting for example conference abstracts. Conclusion PRISMA-COSMIN for OMIs 2024 consists of two checklists (full reports; abstracts), their corresponding explanation and elaboration documents detailing the rationale and examples for each item, and a data flow diagram. PRISMA-COSMIN for OMIs 2024 can improve the reporting of systematic reviews of OMIs, fostering their reproducibility and allowing end-users to appraise the quality of OMIs and select the most appropriate OMI for a specific application. Note In order to encourage its wide dissemination this article is freely accessible on the web sites of the journals: Health and Quality of Life Outcomes; Journal of Clinical Epidemiology; Journal of Patient-Reported Outcomes; Quality of Life Research.

Outcome measurement instruments (OMIs) play a critical role in assessing health outcomes both in clinical practice and in research. Different types of OMIs exist, such as questionnaires or patient-reported outcome measures (PROMs), clinical rating scales or performance-based tests. While there are many OMIs that measure the same outcome domain, selecting the most suitable OMI requires a comprehensive evaluation of the measurement properties, feasibility and interpretability aspects. Such evaluations can be achieved through the conduct of systematic reviews.

Despite various methods available for conducting systematic reviews of OMIs, there is a continuing lack of comprehensive reporting of methods and findings in these reviews’ publications. This incomplete reporting limits reproducibility and hinders the selection of the most appropriate OMI for specific applications. Recognizing this gap, we recently developed a reporting guideline specifically tailored for systematic reviews of OMIs, called PRISMA-COSMIN for OMIs 2024.

New reporting guidance

 To develop PRISMA-COSMIN for OMIs 2024, we adapted the PRISMA 2020 framework by adding new items, modifying existing ones, and ensuring the relevance of all items to systematic reviews of OMIs. This process was an international collaborative effort, and involved a Delphi study, workgroup meetings, and extensive pilot testing. We engaged important partners, including patients and members of the public throughout the development process. As patient and public involvement (PPI) in the development of reporting guidelines is relatively new, we shared our lessons learned in the form of 17 recommendations that future reporting guideline developers can refer to (Figure) in a commentary recently published in Research Involvement and Engagement. Key to the successful integration of patient and public involvement were:

  1. Limiting power imbalances by having a patient on the research team.
  2. Organizing a preparatory meeting for patients and public members to go over key project details and concepts.
  3. Remaining flexible in how patients and public members could contribute.

Figure: 17 steps to meaningful Patient and Public Involvement (PPI) in reporting guideline development

 The impact of PPI on the guideline was evident, as reporting items that may otherwise have been disregarded were included, such as the feasibility and interpretability of OMIs, recommendations on which OMI (not) to use, and the plain language summary. Moreover, suggestions of patients and members of the public for rewording some of the items made the guideline much clearer.

 The resulting PRISMA-COSMIN for OMIs 2024 guideline comprises of a checklist for full systematic review reports and one for abstracts, along with Explanation and Elaboration (E&E) documents. The checklist for full reports contains 54 (sub)items covering various sections of a systematic review report, from the article’s title to the discussion (Table).

Table. PRISMA-COSMIN for outcome measurement instruments 2024 checklist with Abstract items featured

 Tools for authors and reviewers

 PRISMA-COSMIN for OMIs 2024 can be used to guide the reporting of all systematic reviews of OMIs, where at least one measurement property of at least one OMI is evaluated, irrespective of the methodology used to conduct the review. The manuscript detailing the development of PRISMA-COSMIN for OMIs was co-published open access in July 2024 in Health and Quality of Life Outcomes, Journal of Clinical Epidemiology, Journal of Patient-reported Outcomes, and Quality of Life Research. This joint publication underscores the significance of PRISMA-COSMIN for OMIs 2024 to the research community.

 Looking ahead, we anticipate that PRISMA-COSMIN for OMIs 2024 will contribute to enhanced quality and transparency of reporting of systematic reviews of OMIs. It can be used by authors who are drafting their systematic review report, as well as journal editors and peer reviewers to appraise the completeness of reporting. To encourage widespread adoption and implementation, we put in place a comprehensive knowledge translation strategy, including making the guideline available on the websites of the EQUATOR network, PRISMA, and COSMIN. A website dedicated to PRISMA-COSMIN for OMIs 2024 was also created: www.prisma-cosmin.ca. All resources, including the downloadable fillable checklists (in PDF and Word) are available on this website. In addition, we launched an ongoing social media campaign, produced a short explanatory video, one-page tip sheets for each checklist item, and developed patient-focused materials, which all can be found on the website. As of July 2024, authors who register their OMI systematic review in PROSPERO are sent an email alerting them to PRISMA-COSMIN for OMIs 2024. We will evaluate and monitor the implementation of the guideline, and welcome feedback on its use.

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