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COSMIN reporting guideline for studies on measurement properties of patient-reported outcome measures

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Abstract

Purpose

To develop a set of consensus and empirically based reporting recommendations for primary studies of the measurement properties of patient-reported outcome measures (PROMs).

Methods

This study included four phases: 1. Conducting an extensive literature review of recommendations for reporting of studies testing measurement properties of PROMs; 2. Preparing for the Delphi study by identifying experts; 3. Conducting three Delphi rounds aiming for consensus on the item list of recommendations found in phase 1; 4. Developing the COSMIN reporting guideline and user manual.

Results

The literature review resulted in 93 reporting items, included in the first Delphi round. A total of 84 individuals (from 12 countries) agreed to participate in the Delphi study, with 47, 30 and 25 responding in rounds one, two and three, respectively. After three rounds, we achieved consensus on a set of 71 items separated into a set of 35 "common" items (relevant to all studies on measurement properties) and 41 "specific" items (exclusively relevant to one of the nine measurement properties).

Conclusion

Consensus was achieved on a set of 71 items for inclusion in a reporting guideline for studies on measurement properties of PROMs. These items will guide researchers on the necessary information to include in their reports of investigations of measurement properties of PROMs. This guideline will likely improve the completeness of reporting of these important studies.

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Funding

This study was funded by a Methods Grant from the Patient-Centered Outcomes Research Institute.

Author information

Authors and Affiliations

  1. Department of Orthopaedic Surgery, University of Michigan, Ann Arbor, MI, USA

    Joel J. Gagnier & Jianyu Lai

  2. Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor, MI, USA

    Joel J. Gagnier

  3. Department of Epidemiology and Data Science, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, De Boelelaan 1117, Amsterdam, Netherlands

    Lidwine B. Mokkink & Caroline B. Terwee

Authors
  1. Joel J. Gagnier
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  2. Jianyu Lai
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  3. Lidwine B. Mokkink
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  4. Caroline B. Terwee
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Corresponding author

Correspondence to Joel J. Gagnier.

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Conflict of interest

None of the authors has conflict of interest with this research.

Ethical Approval

While all participants agreed to complete the Delphi surveys, formal consent was not sought as this was deemed to be an exempt research by the University of Michigan, Human Subjects study committee. The IRB approval number for this research is HUM00101151.

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Gagnier, J.J., Lai, J., Mokkink, L.B. et al. COSMIN reporting guideline for studies on measurement properties of patient-reported outcome measures. Qual Life Res 30, 2197–2218 (2021). https://doi.org/10.1007/s11136-021-02822-4

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  • DOI: https://doi.org/10.1007/s11136-021-02822-4

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