PTSystematic ReviewEuropean journal of physical and rehabilitation medicine2024

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

Chiara Arienti, Susan Armijo-Olivo, Giorgio Ferriero and 11 others

PMID 38088137

WHAT IT FOUND

Rehabilitation trial quality checks gave mixed answers.

Trials that did not hide who got which treatment, did not blind assessors, omitted key outcomes, or had unclear funding can point to larger effects, but the evidence is too limited to guide practice.

Key findings

01Trials that did not hide how participants were assigned to groups tended to show larger rehabilitation treatment effects, but the difference was not statistically significant.

02Trials using blinded outcome assessors reported smaller muscle strength effects than trials using unblinded assessors, with an effect size difference of -0.80.

03Trials that did not report core outcome measures showed larger pain effect estimates, and this remained associated with larger pain effects after adjustment.

STILL TO COME

How it was doneWhat they foundWhat it means for PTs

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What it does not show

The review found only a small number of rehabilitation studies, and the included studies were exploratory, underpowered, and heterogeneous, so no definitive conclusion could be drawn. The search was narrow and only published English reports were included, so relevant studies may have been missed. The included studies did not assess their own risk of bias, and they included randomized trials of any methodological quality. Definitions of attrition bias and intention-to-treat analysis varied across studies, and one study found overestimation while another found underestimation. Most interventions were physical therapy or exercise, with little information about controls or outcome measurements, limiting generalizability to other rehabilitation interventions. The review did not examine interactions between different biases or other biases such as publication bias and outcome measurement bias. The included studies did not meet recommended sample size standards for adequate power.

Declared interests

The authors certified that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript.

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