Protocol for the mixed-methods development of a concussion-specific health-related quality of life outcome measure based on the international classification of functioning, disability and health

Introduction

Recovery from concussion has traditionally been evaluated by patient-reported symptoms, objective measures such as loss of consciousness, specific dimensions such as depression or fatigue, cognitive status, employment status, level of physical activity and the more complex construct of disability. Increasingly, patient-reported outcome measures of health-related quality of life (HRQOL) are being emphasised as an important end point in patient care, clinical trial and health policy decisions. Currently, no standardised concussion-specific HRQOL outcome measure exists. The process for developing a concussion-specific HRQOL outcome measure based on the international classification of functioning, disability and health is outlined.

Methods and analysis

A multistage, patient-centred approach to developing the outcome measure will integrate evidence from systematic reviews, qualitative research and cognitive interviewing into a self-report questionnaire to guide clinical decision-making. The psychometric properties of the questionnaire will be evaluated to assess the inter-rater reliability and construct validity of the measure in individuals with persistent post-concussion symptoms. To date, the systematic review and the clinical expert interviews within the preparatory phase have been completed and work is progressing on the subsequent phases. It is anticipated that the outcome measure will be ready for psychometric testing in September 2018.

Ethics and dissemination

Ethical approval was granted by the Ottawa Health Science Network Research Ethics Board (Protocol #20170720-01H) on 31 October 2017 to conduct the patient and clinical expert interviews. Ethical approval for psychometric testing of the outcome measure will be sought by the Ottawa Health Science Network Research Ethics Board in Phase II, after the development of the final HRQOL questionnaire. Results will be disseminated through peer-reviewed journals and professional conferences.

PROSPERO registration

Phase I systematic review registration number CRD42017075588 (15 June 2017). Phase II systematic review registration number CRD42017075588 (27 September 2017).

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