Reliability, Validity, and Responsiveness of Clinical Performance-Based Outcome Measures of Walking for Individuals With Lower Limb Amputations: A Systematic Review.

ABSTRACT

Background: Clinical outcome measures are important to use for individuals with lower limb amputations (LLA) because such individuals require intensive functional gait training before and after being fitted with prostheses. Using standardized instruments throughout the episode of care allows clinicians to objectively monitor patient progress, make evidence-based decisions regarding the plan of care, and communicate results in meaningful ways to patients, payers, and other clinicians. Many clinical outcome measures exist, but not all have been validated and shown to be reliable within this population of interest. Purpose: The aim of this review was to provide a comprehensive overview of the psychometric properties of all current performance-based outcome measures applicable to individuals with lower limb amputations. Data Sources Reviewers searched for articles using the online databases PubMed/MEDLINE and CINAHL. Reviewers also conducted a manual search of the reference list of 1 of the previously published systematic reviews to identify any additional studies not detected with the online database search. Study Selection The 2 reviewers screened titles and abstracts for relevance. The same reviewers obtained and read full-text articles of the potentially relevant studies. Reviewers resolved any discrepancies of the inclusion assessment by further discussion. Data Extraction The reviewers created tables to extract psychometric properties of interest from the included articles. Both reviewers extracted the data from the articles and placed relevant values into a table for each primary outcome measure identified. Data Synthesis: The rigor of study reporting was guided by use of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Checklist. Each reviewer independently read and appraised the included articles, assigning a score to each checklist item. The sum of scores for each item was calculated to appraise the overall quality of reporting of the included articles. Limitations: Review-level limitations included the absence of a third reviewer to settle any disagreements on article inclusion and article appraisal. Additionally, the percentage of reviewer agreement on article appraisal was not determined before disagreements about checklist item satisfaction were resolved. Furthermore, reviewers only extracted data on reliability, validity, and responsiveness; instrument characteristics, such as floor and ceiling effects, are also important. Conclusions: Valid and reliable performance-based clinical measures of ambulation in individuals with LLA were identified. Further research should investigate the minimally clinical, important difference of these clinical measures and address trends in unmet reporting guidelines.