Almost one in five physiotherapy trials excluded people due to lack of language proficiency: A meta-epidemiological study

Abstract

Objectives: The objective of the study was to examine the characteristics of randomized controlled trials (RCTs) evaluating physiotherapy interventions for low back pain (LBP) that specified a language-grounded eligibility criterion and the proportion of people being excluded consequently.

Study design and setting: This is a meta-epidemiological study of RCTs evaluating at least one type of physiotherapy intervention for treatment or prevention of LBP. Records were retrieved from Physiotherapy Evidence Database (PEDro), LILACS, and SciELO from inception to May 2021. We retrieved metadata of each record from PEDro and extracted from included studies: country of recruitment, language-grounded eligibility criterion, and the number of consequent exclusions (if specified).

Results: This study included 2,555 trials. A language-grounded eligibility criterion was specified in 463 trials (18.1%); the proportion was higher in trials conducted in North America and Europe, published after 2000, investigating cognitive and behavioral interventions, and including large sample size. Of these 463 trials, 75 trials (16.2%) reported a total number of 2,152 people being excluded due to lack of language proficiency, equivalent to 12.5% of randomized participants.

Conclusion: Nearly one in five physiotherapy clinical trials on LBP excludes people based on language proficiency, compromising the evidence to manage LBP in minority populations.

Keywords: Country of recruitment; Eligibility criteria; Language proficiency; Low back pain; Physiotherapy; Randomized trials.