TY - JOUR
T1 - The interpretation of clinical relevance in randomised clinical trials in patients with chronic low back pain
T2 - protocol for a meta-research study
AU - Innocenti, Tiziano
AU - Schleimer, Tim
AU - Salvioli, Stefano
AU - Giagio, Silvia
AU - Ostelo, Raymond
AU - Chiarotto, Alessandro
N1 - Funding Information: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Publisher Copyright: © 2023 The Author(s)
PY - 2023/1/1
Y1 - 2023/1/1
N2 - Chronic low back pain (cLBP) is one of the leading worldwide causes of disability. The smallest worthwhile effect (SWE) parameter has been proposed to find a threshold of clinical relevance. Specific values of the SWE have been calculated in patients with cLBP for pain intensity, physical functioning and time to recovery for physiotherapy compared with no intervention. Our objectives are 1) To evaluate how authors have interpreted the clinical relevance of the effect of physiotherapy compared to no-intervention on pain, physical functioning and time to recovery; 2) To reinterpret the clinical relevance of these between-group differences based on the available SWE estimates; 3) To evaluate, for descriptive purposes, whether the studies are adequately powered or underpowered considering the published SWE values and a power threshold of 80%. A systematic search in Medline, PEDro, Embase and Cochrane CENTRAL will be conducted. We will search for RCT investigating the effectiveness of physiotherapy as compared to no interventions in people with cLBP. We will compare the authors' interpretation of results for clinical relevance with their results to determine if they meet their a-priori definitions. Then, we will perform a re-interpretation of the between-group differences based on SWE values published for cLBP.
AB - Chronic low back pain (cLBP) is one of the leading worldwide causes of disability. The smallest worthwhile effect (SWE) parameter has been proposed to find a threshold of clinical relevance. Specific values of the SWE have been calculated in patients with cLBP for pain intensity, physical functioning and time to recovery for physiotherapy compared with no intervention. Our objectives are 1) To evaluate how authors have interpreted the clinical relevance of the effect of physiotherapy compared to no-intervention on pain, physical functioning and time to recovery; 2) To reinterpret the clinical relevance of these between-group differences based on the available SWE estimates; 3) To evaluate, for descriptive purposes, whether the studies are adequately powered or underpowered considering the published SWE values and a power threshold of 80%. A systematic search in Medline, PEDro, Embase and Cochrane CENTRAL will be conducted. We will search for RCT investigating the effectiveness of physiotherapy as compared to no interventions in people with cLBP. We will compare the authors' interpretation of results for clinical relevance with their results to determine if they meet their a-priori definitions. Then, we will perform a re-interpretation of the between-group differences based on SWE values published for cLBP.
KW - Clinical relevance
KW - Low back pain
KW - Meta-epidemiology
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U2 - https://doi.org/10.1016/j.mex.2023.102239
DO - https://doi.org/10.1016/j.mex.2023.102239
M3 - Article
C2 - 37305803
SN - 2215-0161
VL - 10
JO - MethodsX
JF - MethodsX
M1 - 102239
ER -