Introduction patient-reported outcome measures (PROMs) are instruments used to measure outcomes and experiences of healthcare from the patient perspective. The specific methodology used to develop a PROM should be communicated to establish the quality of the instrument. This mixed methods protocol describes the development of a cross-cultural, internationally applicable PROM for hand conditions, the HAND-Q.
Methods and analysis The multiphase approach used for this study has been previously used with the development of other PROMs by our team (eg, BODY-Q, BREAST-Q, CLEFT-Q, FACE-Q). In Phase I, we establish what important concepts matter to patients with hand conditions. A conceptual framework is developed from a systematic review of existing PROMs in the field and an extensive international qualitative study. Interpretive description is the qualitative approach used. Item generation is based on the qualitative data. The preliminary scales will be created for each theme identified in the conceptual framework. These scales will be refined by cognitive debriefing interviews with participants and expert input. Phase II involves a large international sample of patients with varied hand conditions completing the field-test version of the HAND-Q. The scales will be refined using the modern psychometric approach of Rasch Measurement Theory. Analysis will result in a shortened set of clinically meaningful and scientifically robust HAND-Q scales.
Ethics and dissemination This study is coordinated at Flinders University (Adelaide, Australia) where it has ethics board approval for phase I and phase II. Findings will be published in peer-reviewed journals and presented at local, national and international conferences.
- patient reported outcome measures
- qualitative research
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Contributors KS prepared the manuscript with the oversight of NRD, GIB, PAG, DL and AK. AK, ALP and SJC developed the methodology used for the development of the HAND-Q and guided the content of the protocol. All authors reviewed the protocol manuscript and gave valuable feedback to the paper.
Funding This work has received funding from the Australasian Foundation for Plastic Surgery Plastic & Reconstructive Surgery (PRS) Research Scholarship and the Royal Australasian College of Surgeons, Foundation for Surgery Small Project Grant. The authors have no financial interest to declare in relation to the content of this article. The article processing charge was paid from the PRS Research Scholarship.
Competing interests None declared.
Ethics approval This international study is coordinated from Flinders University where the Southern Adelaide Clinical Human Research Ethics Committee has approved phase I and II.
Provenance and peer review Not commissioned; externally peer reviewed.
Patient consent for publication Not required.
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