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Guidelines for the development and validation of patient-reported outcome measures: a scoping review
  1. Andres Jung1,2,
  2. Dimitris Challoumas3,
  3. Larissa Pagels1,
  4. Susan Armijo-Olivo4,5,
  5. Tobias Braun6,7,
  6. Kerstin Luedtke1,8
  1. 1Institute of Health Sciences, Department of Physiotherapy, Pain and Exercise Research Luebeck (P.E.R.L), Universität zu Lübeck, Lübeck, Germany
  2. 2Department of Sport Science and Sport, Friedrich-Alexander Universität Erlangen-Nürnberg, Erlangen, Germany
  3. 3Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK
  4. 4Faculty of Business and Social Sciences, Hochschule Osnabrück, Osnabrück, Germany
  5. 5Faculty of Rehabilitation Medicine, Department of Physical Therapy, Rehabilitation Research Center, University of Alberta, Edmonton, Alberta, Canada
  6. 6Department of Applied Health Sciences, Division of Physiotherapy, Hochschule für Gesundheit Bochum, Bochum, Germany
  7. 7Department of Health, HSD Hochschule Dopfer GmbH, Köln, Germany
  8. 8Center of Brain, Behavior and Metabolism (CBBM), Universität zu Lübeck, Lübeck, Germany
  1. Correspondence to Andres Jung, Institute of Health Sciences, Department of Physiotherapy, Pain and Exercise Research Luebeck (P.E.R.L), Universität zu Lübeck, Lubeck 23562, Germany; andres.jung{at}


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).

  • Methods
  • Health Care Quality, Access, and Evaluation
  • Systematic Reviews as Topic

Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information.

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Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information.

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  • Contributors All authors contributed to the design of the study. AJ and SA-O designed the search strategy and conducted the systematic search. AJ, DC and LP screened titles and abstracts as well as full-text reports. Data extraction was performed by AJ and checked by LP. Data synthesis was performed by AJ and LP. AJ drafted the manuscript. DC, LP, TB, SA-O and KL critically revised the manuscript for important intellectual content. All authors read and approved the final manuscript. AJ is responsible for the overall content as guarantor.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.