Psychometric properties of outcome measures for lower-limb absence: A protocol for a systematic review

Abstract

Background: Outcome measures are an important part of clinical practice to assist with the care of individuals with lower-limb absence (LLA). They aid with the devising and evaluation of rehabilitation plans, and guide decisions regarding the provision and funding of prosthetic services worldwide. To date, no outcome measure has been identified as a gold standard for use in individuals with LLA. Furthermore, the large number of outcome measures available has created uncertainty regarding outcome measures that are most appropriate for individuals with LLA. Objective: To critically appraise the existing literature related to the psychometric properties of outcome measures for use in individuals with LLA and provide evidence as to which outcome measures may be most appropriate for this clinical population. Study design: This is a systematic review protocol. Methods: CINAHL, Embase, MEDLINE (PubMed), and PsycINFO databases will be searched using a combination of Medical Subject Headings terms and keywords. Search terms that define the population (people with LLA or amputation), intervention (outcome measures), and outcome (psychometric properties) will be used to identify studies. The reference lists of included studies will be hand-search to identify other pertinent articles, with a further search conducted through Google Scholar to ensure that all studies not yet indexed through MEDLINE are captured. Full-text peer-reviewed journal studies published in English will be included, with no date limit set. Included studies will be appraised using the 2018 and 2020 COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklists. Data extraction and study appraisal will be completed by two authors, with a third author serving as an adjudicator. Quantitative synthesis will be used to summarize characteristics of the included studies, with kappa statistics used to determine agreement between authors for study inclusion and the application of COSMIN. Qualitative synthesis will be conducted to report on both quality of the included studies and psychometric properties of the included outcome measures. Conclusion: This protocol was designed to identify, appraise, and summarize patient-reported and performance-based outcome measures that have been psychometrically tested in people with LLA. Results from this review will be used to guide a consensus process on outcome measure use for people with LLA. Systematic review registration: PROSPERO registry number: CRD42020217820.