Evidence-based treatment and healthcare policy decision making rests on information collected in research studies. Health outcome measurements are only as good as the outcome measurement instruments (OMIs) used to make them. Yet, the use of OMIs with poor or unknown quality is widespread in clinical research, hindering therapy development. While appraisal tools for the selection of the most suitable OMIs have been developed by the COnsensus based Standards for the selection of health Measurement INstruments (COSMIN) initiative, key information is often missing in published systematic reviews. To ensure measurements are valid, reliable, patient-centered, and comparable across research studies and health systems, complete reporting of OMI appraisal is essential. However, there was no consensus on what constitutes complete and sufficient reporting.
To address this issue, we assembled an international group of experts to develop an evidence-informed and consensus-based reporting guideline: PRISMA-COSMIN for OMIs. Our team included OMI developers, measurement experts, systematic reviewers, OMI users such as doctors and researchers, checklist developers, and users of knowledge generated by OMIs including patients. The new checklist, developed using cutting edge research methods, was tested across various health disciplines and OMI systematic reviews. The checklist is freely available worldwide and will have a global impact by teaching researchers how to report their systematic reviews on OMIs appropriately, so that measurements made are useful, correct, and meaningful. Our work will improve the quality of systematic reviews of OMIs and contribute towards reducing research waste, informing health decisions, and ultimately improving patient and health system outcomes.
The PRISMA-COSMIN for OMIs guideline has been endorsed for use by academic journals and are published open access in four journals: Quality of Life Research, Journal of Clinical Epidemiology, Health and Quality of Life Outcomes, Journal of Patient-Reported Outcomes. Links to all four publications are available under the “Publications” tab below.
Various resources, such as the downloadable checklist and tip sheets are freely accessible:
- The full guideline and downloadable checklists (in PDF and Word) are under the tab, “The PRISMA-COSMIN for OMIs Guideline and Checklists (Download)”
- The tip sheets for each reporting item are under the tab, “Tip Sheets for Systematic Review Authors”
- Tip sheets for Patients are under the tab, “Tip Sheets for Patients”
PRISMA-COSMIN for OMIs End of Project Meeting, June 28-29, 2023. Front row, from left: David Moher, Wieneke Mokkink, Ellen Elsman, Catherine Hofstetter, Martin Offringa. Back row, from left: Andrea Tricco, Krystle Amog, Dorcas Beaton, Joel Gagnier, Caroline Terwee, Ami Baba, Maureen Smith.
We were awarded a three-year CIHR Project Grant to develop PRISMA-COSMIN for OMIs. A study protocol outlining the methods for developing, piloting, and disseminating the PRISMA-COSMIN for OMIs guideline has been published open access in the journal “Systematic Reviews”. We have finalized a three-round Delphi study and organized a hybrid workgroup meeting to agree on the wording and inclusion of reporting items that had no consensus yet. Writing teams have drafted the Explanation & Elaboration (E&E) texts for each reporting item. We have pilot tested the checklists and E&E documents with authors of systematic reviews of OMIs. We also held a two-day end-of-project meeting to finalize the PRISMA-COSMIN for OMIs guideline. In order to encourage its wide dissemination the guideline is co-published open access in Health and Quality of Life Outcomes, Journal of Clinical Epidemiology, Journal of Patient-reported Outcomes, and Quality of Life Research. A blueprint with 17 recommendations on how to integrate patient and public involvement in the development of reporting guidelines has been published as well. With the publication of all materials, the project is finalized.
The guideline is published open access in several journals:
PRISMA-COSMIN for OMIs 2024 is a stand-alone extension of PRISMA 2020, specifically intended for reporting systematic reviews of OMIs where at least one measurement property of at least one OMI is evaluated. PRISMA-COSMIN for OMIs 2024 is intended for all systematic reviews of OMIs, conducted with any methodology or tools; it does not specifically apply to systematic reviews conducted with the methodology or tools from the COSMIN initiative. PRISMA-COSMIN for OMIs 2024 consists of a checklist, a flow diagram, and an Explanation & Elaboration (E&E) document.
In order to encourage its wide dissemination, the guideline is published open access in several journals:
- Elsman EBM, Mokkink LB, Terwee CB, Beaton D, Gagnier JJ, Tricco AC, Baba A, Butcher NJ, Smith M, Hofstetter C, Lee Aiyegbusi O, Berardi A, Farmer J, Haywood KL, Krause KR, Markham S, Mayo-Wilson E, Mehdipour A, Ricketts J, Szatmari P, Touma Z, Moher D, Offringa M. Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024. Quality of Life Research (2024), doi: https://doi.org/10.1007/s11136-024-03634-y.
- Elsman EBM, Mokkink LB, Terwee CB, Beaton D, Gagnier JJ, Tricco AC, Baba A, Butcher NJ, Smith M, Hofstetter C, Lee Aiyegbusi O, Berardi A, Farmer J, Haywood KL, Krause KR, Markham S, Mayo-Wilson E, Mehdipour A, Ricketts J, Szatmari P, Touma Z, Moher D, Offringa M. Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024. Journal of Clinical Epidemiology (2024), doi: https://doi.org/10.1016/j.jclinepi.2024.111422.
- Elsman EBM, Mokkink LB, Terwee CB, Beaton D, Gagnier JJ, Tricco AC, Baba A, Butcher NJ, Smith M, Hofstetter C, Lee Aiyegbusi O, Berardi A, Farmer J, Haywood KL, Krause KR, Markham S, Mayo-Wilson E, Mehdipour A, Ricketts J, Szatmari P, Touma Z, Moher D, Offringa M. Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024. Health and Quality of Life Outcomes (2024), doi: https://doi.org/10.1186/s12955-024-02256-9.
- Elsman EBM, Mokkink LB, Terwee CB, Beaton D, Gagnier JJ, Tricco AC, Baba A, Butcher NJ, Smith M, Hofstetter C, Lee Aiyegbusi O, Berardi A, Farmer J, Haywood KL, Krause KR, Markham S, Mayo-Wilson E, Mehdipour A, Ricketts J, Szatmari P, Touma Z, Moher D, Offringa M. Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024. Journal of Patient-Reported Outcomes (2024), doi: https://doi.org/10.1186/s41687-024-00727-7.
Checklist
The checklist for full reports contains 54 (sub)items, addressing the Title, Abstract, Plain language summary, Open science, Introduction, Methods, Results and Discussion sections of an OMI systematic review.
A checklist for abstracts (journal or conference abstracts) contains 13 items.
Explanation & Elaboration
It is strongly recommended that the PRISMA-COSMIN for OMIs checklists are used in conjunction with their respective Explanation & Elaboration (E&E) documents. The E&E documents are intended to enhance the use, understanding and dissemination of PRISMA-COSMIN for OMIs. Through examples and explanations, the meaning and rationale for each checklist item are presented.
Flow diagram
The flow diagram depicts the flow of information through the different phases of an OMI systematic review. It maps out the number of records identified, included and excluded, and the reasons for exclusion.
- PRISMA-COSMIN for OMIs Flow diagram (PowerPoint)
PRISMA-COSMIN for OMIs Tip Sheets for Full Reports:
- Item 1: Title
- Item 2: Abstract
- Item 3: Plain language summary
- Item 4a: Registration and protocol – Registration information
- Item 4b: Registration and protocol – Accession of protocol
- Item 4c: Registration and protocol – Protocol amendments
- Item 5: Support
- Item 6: Competing interests
- Item 7: Availability of data and other materials
- Item 8: Rationale
- Item 9: Objectives
- Item 10: Followed guidelines
- Item 11: Eligibility criteria
- Item 12: Information sources
- Item 13: Search strategy
- Item 14: Selection process
- Item 15: Data collection process
- Item 16: Data items
- Item 17: Study risk of bias assessment
- Item 18: Measurement properties
- Item 19a: Synthesis methods – Eligibility processes
- Item 19b: Synthesis methods – Methods for synthesis
- Item 19c: Synthesis methods – Causes of inconsistency
- Item 19d: Synthesis methods – Sensitivity analyses
- Item 20: Certainty assessment
- Item 21: Formulating recommendations
- Item 22a: Study selection – Results of search and selection
- Item 22b: Study selection – Excluded reports with reasons
- Item 23a: OMI characteristics – Characteristics of OMIs
- Item 23b: OMI characteristics – Interpretability aspects of OMIs
- Item 23c: OMI characteristics – Feasibility aspects of OMIs
- Item 24: Study characteristics
- Item 25: Risk of bias in studies
- Item 26: Results of individual studies
- Item 27a: Results of syntheses – Results of syntheses conducted
- Item 27b: Results of syntheses – Results of causes of inconsistency
- Item 27c: Results of syntheses – Results of sensitivity analyses
- Item 28: Certainty of evidence
- Item 29: Recommendations
- Item 30a: Discussion – Interpretation of results
- Item 30b: Discussion – Limitations of evidence
- Item 30c: Discussion – Limitations of review processes
- Item 30d: Discussion – Implications
PRISMA-COSMIN for OMIs Tip Sheets for Abstracts:
- Item 2.1: Title
- Item 2.2: Funding
- Item 2.3: Registration
- Item 2.4: Objectives
- Item 2.5: Eligibility criteria
- Item 2.6: Information sources
- Item 2.7: Risk of bias
- Item 2.8: Measurement properties
- Item 2.9: Synthesis methods
- Item 2.10: Included studies
- Item 2.11: Synthesis of results
- Item 2.12: Limitations of evidence
- Item 2.13: Interpretation
PRISMA-COSMIN for OMIs Tip Sheets for Patients:
The Research Brief is available for download (PDF)
Please use one of the following publications (open access) when referring to PRISMA-COSMIN for OMIs:
- Elsman EBM, Mokkink LB, Terwee CB, Beaton D, Gagnier JJ, Tricco AC, Baba A, Butcher NJ, Smith M, Hofstetter C, Lee Aiyegbusi O, Berardi A, Farmer J, Haywood KL, Krause KR, Markham S, Mayo-Wilson E, Mehdipour A, Ricketts J, Szatmari P, Touma Z, Moher D, Offringa M. Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024. Quality of Life Research (2024), doi: https://doi.org/10.1007/s11136-024-03634-y.
- Elsman EBM, Mokkink LB, Terwee CB, Beaton D, Gagnier JJ, Tricco AC, Baba A, Butcher NJ, Smith M, Hofstetter C, Lee Aiyegbusi O, Berardi A, Farmer J, Haywood KL, Krause KR, Markham S, Mayo-Wilson E, Mehdipour A, Ricketts J, Szatmari P, Touma Z, Moher D, Offringa M. Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024. Journal of Clinical Epidemiology (2024), doi: https://doi.org/10.1016/j.jclinepi.2024.111422.
- Elsman EBM, Mokkink LB, Terwee CB, Beaton D, Gagnier JJ, Tricco AC, Baba A, Butcher NJ, Smith M, Hofstetter C, Lee Aiyegbusi O, Berardi A, Farmer J, Haywood KL, Krause KR, Markham S, Mayo-Wilson E, Mehdipour A, Ricketts J, Szatmari P, Touma Z, Moher D, Offringa M. Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024. Health and Quality of Life Outcomes (2024), doi: https://doi.org/10.1186/s12955-024-02256-9.
- Elsman EBM, Mokkink LB, Terwee CB, Beaton D, Gagnier JJ, Tricco AC, Baba A, Butcher NJ, Smith M, Hofstetter C, Lee Aiyegbusi O, Berardi A, Farmer J, Haywood KL, Krause KR, Markham S, Mayo-Wilson E, Mehdipour A, Ricketts J, Szatmari P, Touma Z, Moher D, Offringa M. Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024. Journal of Patient-Reported Outcomes (2024), doi: https://doi.org/10.1186/s41687-024-00727-7.
The COSMIN initiative is developing an online course on how to conduct systematic reviews of OMIs. Details will be posted here when available.
This project is funded by Canadian Institutes of Health Research (CIHR).
Logo designed by Matthew Prebeg
Updated August 2024