The influence of bias in randomized controlled trials on rehabilitation intervention effect estimates: what we have learned from meta-epidemiological studies

Abstract

This study aimed to synthesize evidence from studies that addressed the influence of bias domains in randomized controlled trials on rehabilitation intervention effect estimates and discuss how these findings can maximize the trustworthiness of an RCT in rehabilitation. We screened studies about the influence of bias on rehabilitation intervention effect estimates published until June 2023. The characteristics and results of the included studies were categorized based on methodological characteristics and summarized narratively. We included seven studies with data on 227,806 RCT participants. Our findings showed that rehabilitation intervention effect estimates are likely exaggerated in trials with inadequate/unclear sequence generation and allocation concealment when using continuous outcomes. The influence of blinding was inconsistent and different from the rest of medical science, as meta-epidemiological studies showed overestimation, underestimation, or neutral associations for different types of blinding on rehabilitation treatment effect estimates. Still, it showed a more consistent pattern when looking at patient-reported outcomes. The impact of attrition bias and intention to treat has been analyzed only in two studies with inconsistent results. The risk of reporting bias seems to be associated with overestimation of treatment effects. Bias domains can influence rehabilitation treatment effects in different directions. The evidence is mixed and inconclusive due to the poor methodological quality of RCTs and the limited number and quality of studies looking at the influence of bias and treatment effects in rehabilitation. Further studies about the influence of bias in RCTs on rehabilitation intervention effect estimates are needed.

Current and Future Challenges for Rehabilitation for Inflammatory Arthritis

“…Overall, due to the abovementioned challenges, clinical trials in rehabilitation are prone to the introduction of various sources of bias [ 55 ]. A number of bias domains, including blinding, can result in either underestimation or overestimation of treatment effects, although the precise impact of bias in RCTs in rehabilitation is difficult to determine [ 55 ].…”

“…Overall, due to the abovementioned challenges, clinical trials in rehabilitation are prone to the introduction of various sources of bias [ 55 ]. A number of bias domains, including blinding, can result in either underestimation or overestimation of treatment effects, although the precise impact of bias in RCTs in rehabilitation is difficult to determine [ 55 ]. Nevertheless, it is very much recommended for researchers in rehabilitation to adhere to the appropriate guidelines for this particular research area, in particular the Consolidated Standards of Reporting Trials (CONSORT) Extension for nonpharmacological trials [ 56 , 57 ] and the previously mentioned TIDIER template [ 49 ].…”