Abstract
Background:
Systematic error undermines the internal validity of randomized controlled trials (RCTs). Elucidating how risk of bias (RoB) domains distort effect estimates strengthens evidence trustworthiness. Low back pain (LBP) research provides a representative field for this investigation, with spinal manipulative therapy (SMT) serving as a widely utilized intervention.
Objective:
To explore the association between risk of bias domains and effect estimates of SMT treatment in LBP trials.
Methods:
RCTs from the Cochrane systematic reviews which have examined the effect of SMT for acute and chronic LBP will be included. The Cochrane RoB 2 tool will be used. The influence of RoB domains on effect estimates for pain intensity and physical functioning will be explored through univariable and multivariable meta-regression models. Models will be adjusted for confounders identified through a directed acyclic graph, including sample size, trial registration, country income level, and comparator type, while exploring interactions.
Significance:
This study builds upon research in exercise therapy, investigating whether the association between RoB and effect estimates is consistent across other non-pharmacological LBP interventions. Findings may help refine the application of GRADE on SMT, and improve evidence synthesis and decision-making for researchers and policymakers.
Keywords:
Effect sizes; Low back pain; Meta-epidemiological study; Randomized controlled trials; Risk of bias; Spinal manipulative therapy.
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