The influence of bias in randomized controlled trials on rehabilitation intervention effect estimates: what we have learned from meta-epidemiological studies.
Citation:
Arienti, C., Armijo-Olivo, S., Ferriero, G., Feys, P., Hoogeboom, T., Kiekens, C., Lazzarini, S. G., Minozzi, S., Negrini, S., Oral, A., Pollini, E., Puljak, L., Todhunter-Brown, A., Walshe, M, The influence of bias in randomized controlled trials on rehabilitation intervention effect estimates: what we have learned from meta-epidemiological studies., European journal of physical and rehabilitation medicine, 2023Download Item:
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.
Author's Homepage:
http://people.tcd.ie/walshema
Author: Walshe, Margaret
Type of material:
Journal ArticleSeries/Report no:
European journal of physical and rehabilitation medicine;Availability:
Full text availableSubject (TCD):
International Development , CLINICAL TRIALS , Evidence based practice , REHABILITATIONDOI:
https://doi.org/10.23736/S1973-9087.23.08310-7Metadata
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