Guidelines for the development and validation of patient-reported outcome measures: a scoping review

Jung A, Challoumas D, Pagels L, Armijo-Olivo S, Braun T, Luedtke K (2024)

Publication Type: Journal article

Publication year: 2024

Journal

BMJ Evidence-Based Medicine BMJ Publishing Group

Pages Range: bmjebm-2023-112681

DOI: 10.1136/bmjebm-2023-112681

Abstract

Objective The objectives of this scoping review were to provide an overview of existing guidelines for the development and validation of patient-reported outcome measures (PROMs), review them for comprehensiveness and clarity and provide recommendations for their use based on the goals of the instrument developers.


Design Scoping review.


Methods A literature search was performed in PubMed, Scopus, PsycInfo and Google Scholar up to 2 June 2023 to identify guidelines for the development and validation of PROMs. Screening of records and reports as well as data extraction were performed by two reviewers. To assess the comprehensiveness of the included guidelines, a mapping synthesis was performed and steps to develop and validate a measurement instrument outlined in the included guidelines were mapped to an a priori framework including 20 steps, which was based on the guideline by de Vet et al.


Results A total of 40 guidelines were included. Statistical advice (at least partially) was provided in 98% of the guidelines (39/40) and 88% (35/40) of the guidelines included examples for steps required to develop and validate PROMs. However, 78% (31/40) of the guidelines were not comprehensive and two essential steps in PROM development (‘consideration and elaboration of the measurement model’ and ‘responsiveness’) were not included in 80% and 72% of the guidelines, respectively. Three guidelines included all 20 steps and six included almost all steps (≥90% of steps) for developing and validating a PROM.


Discussion Most guidelines on PROM development and validation do not appear to be comprehensive, and some crucial steps are missing in most guidelines. Nevertheless, for some purposes of PROMs, many guidelines provide helpful advice and support.


Conclusion At least 15 guidelines may be recommended, including three comprehensive guidelines that can be recommended for the development and validation of PROMs for most purposes (eg, to discriminate between subjects with a particular condition and subjects without that condition, to evaluate the effects of treatments (between a pre and post time-points) or to evaluate a status quo).

Authors with CRIS profile

Andres Jung Lehrstuhl für Sportwissenschaft mit dem Schwerpunkt Bewegung und Gesundheit

Involved external institutions

Hochschule Osnabrück DE Germany (DE) Universität zu Lübeck DE Germany (DE) Hochschule für Gesundheit DE Germany (DE) University of Glasgow GB United Kingdom (GB)

How to cite

APA:

Jung, A., Challoumas, D., Pagels, L., Armijo-Olivo, S., Braun, T., & Luedtke, K. (2024). Guidelines for the development and validation of patient-reported outcome measures: a scoping review. BMJ Evidence-Based Medicine, bmjebm-2023-112681. https://doi.org/10.1136/bmjebm-2023-112681

MLA:

Jung, Andres, et al. "Guidelines for the development and validation of patient-reported outcome measures: a scoping review." BMJ Evidence-Based Medicine (2024): bmjebm-2023-112681.

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