INTRODUCTION: The Physiotherapy Evidence Database (PEDro) scale has been widely used to investigate methodological quality in physiotherapy randomised controlled trials; however its validity has not been tested for pharmaceutical trials. The aim of this study was to investigate the validity and inter-rater reliability of the PEDro scale for pharmaceutical trials. The reliability was also examined for the Cochrane Back and Neck (CBN) Group risk of bias tool.
METHODS: This is a secondary analysis of data from a previous study. We considered randomised placebo controlled trials evaluating any pain medication for chronic spinal pain or osteoarthritis. Convergent validity was evaluated by correlating the PEDro score with the summary score of the CBN risk of bias tool. The construct validity was tested using a linear regression analysis to determine the degree to which the total PEDro score is associated with treatment effect sizes, journal impact factor and the summary score for the CBN risk of bias tool. The inter-rater reliability was estimated using the Prevalence and Bias Adjusted Kappa (PABAK) coefficient and 95%CI for the PEDro scale and CBN risk of bias tool.
RESULTS: Fifty-three trials were included, with 91 treatment effect sizes included in the analyses. The correlation between PEDro scale and CBN risk of bias tool was 0.83 (95% CI 0.76 to 0.88) after adjusting for reliability, indicating strong convergence. The PEDro score was inversely associated with effect sizes, significantly associated with the summary score for the CBN risk of bias tool, and not associated with the journal impact factor. The inter-rater reliability for each item of the PEDro scale and CBN risk of bias tool was at least substantial for most items (>0.60). The ICC for the PEDro score was 0.80 (95% CI 0.68 to 0.88), and for the CBN risk of bias tool was 0.81 (95% CI 0.69 to 0.88).
CONCLUSION: There was evidence for the convergent and construct validity for the PEDro scale when used to evaluate methodological quality of pharmacological trials. Both risk of bias tools have acceptably high inter-rater reliability.
BT - J Clin Epidemiol C1 - http://www.ncbi.nlm.nih.gov/pubmed/28288916?dopt=Abstract DO - 10.1016/j.jclinepi.2017.03.002 LA - eng N2 -INTRODUCTION: The Physiotherapy Evidence Database (PEDro) scale has been widely used to investigate methodological quality in physiotherapy randomised controlled trials; however its validity has not been tested for pharmaceutical trials. The aim of this study was to investigate the validity and inter-rater reliability of the PEDro scale for pharmaceutical trials. The reliability was also examined for the Cochrane Back and Neck (CBN) Group risk of bias tool.
METHODS: This is a secondary analysis of data from a previous study. We considered randomised placebo controlled trials evaluating any pain medication for chronic spinal pain or osteoarthritis. Convergent validity was evaluated by correlating the PEDro score with the summary score of the CBN risk of bias tool. The construct validity was tested using a linear regression analysis to determine the degree to which the total PEDro score is associated with treatment effect sizes, journal impact factor and the summary score for the CBN risk of bias tool. The inter-rater reliability was estimated using the Prevalence and Bias Adjusted Kappa (PABAK) coefficient and 95%CI for the PEDro scale and CBN risk of bias tool.
RESULTS: Fifty-three trials were included, with 91 treatment effect sizes included in the analyses. The correlation between PEDro scale and CBN risk of bias tool was 0.83 (95% CI 0.76 to 0.88) after adjusting for reliability, indicating strong convergence. The PEDro score was inversely associated with effect sizes, significantly associated with the summary score for the CBN risk of bias tool, and not associated with the journal impact factor. The inter-rater reliability for each item of the PEDro scale and CBN risk of bias tool was at least substantial for most items (>0.60). The ICC for the PEDro score was 0.80 (95% CI 0.68 to 0.88), and for the CBN risk of bias tool was 0.81 (95% CI 0.69 to 0.88).
CONCLUSION: There was evidence for the convergent and construct validity for the PEDro scale when used to evaluate methodological quality of pharmacological trials. Both risk of bias tools have acceptably high inter-rater reliability.
PY - 2017 T2 - J Clin Epidemiol TI - The PEDro scale had acceptably high convergent validity, construct validity and inter-rater reliability in evaluating methodological quality of pharmaceutical trials. SN - 1878-5921 ER -