Article type
Year
Abstract
Background: the number of randomized controlled trials (RCTs) in manual therapy (MT) has increased exponentially. However, the quality of the reports remains heterogeneous.
Objectives: to describe the reports of the information necessary for the interpretation of the results in RCTs in MT and to compare the RCTs' reports before and after the publication of CONSORT standards for non-pharmacological clinical trials.
Methods: we conducted a methodological review, with an exhaustive search strategy in PubMed and CENTRAL in the area of MT published between the year 2000 and 2015. From the total number of articles found, we took a random sample of 100 trials that met the eligibility criteria (RCT design, MT intervention, English language); 50 trials published before and 50 published after the development of CONSORT standards. We designed and piloted a data extraction form. For each RCT we identified the primary variable, which had to be differentiated from the rest of the variables. If this was not an explicit statement, we considered the variable used for the calculation of the sample size, or the first reported in the results section. The information collected for each RCT was: hypothesis declaration, sample size calculation, report of patients lost to follow-up, clinical relevance threshold, estimated effect size reported for each group and for comparison between groups. The comparison between pre- and post-CONSORT was done using the Chi2 test.
Results: 42% of the trials explicitly declared the study hypothesis and 40% the primary variable. 54% of the trials did not calculate the sample size. 76% of the trials made a complete report of the losses. 56% reported the estimated effect size for each group and 26% the comparative measure between groups (including the estimated effect size and its precision). Only 46% of the trials declared a threshold of clinical relevance for any of the results. There were no significant differences when comparing the trials before and after CONSORT (P > 0.05).
Conclusions: currently, there is an important deficit in reporting the information necessary for a correct interpretation of the results in RCTs in MT, despite the recommendations published by CONSORT. Improvements in reporting are necessary to generate advances in physiotherapy practice.
Patient or healthcare consumer involvement: trials with poor methodological quality are more likely to provide biased estimates of treatment effects. The importance of precision in the reporting of results allows researchers to learn from colleagues' mistakes, replicate positive findings and facilitate a clear understanding of the implications for clinical practice.
Objectives: to describe the reports of the information necessary for the interpretation of the results in RCTs in MT and to compare the RCTs' reports before and after the publication of CONSORT standards for non-pharmacological clinical trials.
Methods: we conducted a methodological review, with an exhaustive search strategy in PubMed and CENTRAL in the area of MT published between the year 2000 and 2015. From the total number of articles found, we took a random sample of 100 trials that met the eligibility criteria (RCT design, MT intervention, English language); 50 trials published before and 50 published after the development of CONSORT standards. We designed and piloted a data extraction form. For each RCT we identified the primary variable, which had to be differentiated from the rest of the variables. If this was not an explicit statement, we considered the variable used for the calculation of the sample size, or the first reported in the results section. The information collected for each RCT was: hypothesis declaration, sample size calculation, report of patients lost to follow-up, clinical relevance threshold, estimated effect size reported for each group and for comparison between groups. The comparison between pre- and post-CONSORT was done using the Chi2 test.
Results: 42% of the trials explicitly declared the study hypothesis and 40% the primary variable. 54% of the trials did not calculate the sample size. 76% of the trials made a complete report of the losses. 56% reported the estimated effect size for each group and 26% the comparative measure between groups (including the estimated effect size and its precision). Only 46% of the trials declared a threshold of clinical relevance for any of the results. There were no significant differences when comparing the trials before and after CONSORT (P > 0.05).
Conclusions: currently, there is an important deficit in reporting the information necessary for a correct interpretation of the results in RCTs in MT, despite the recommendations published by CONSORT. Improvements in reporting are necessary to generate advances in physiotherapy practice.
Patient or healthcare consumer involvement: trials with poor methodological quality are more likely to provide biased estimates of treatment effects. The importance of precision in the reporting of results allows researchers to learn from colleagues' mistakes, replicate positive findings and facilitate a clear understanding of the implications for clinical practice.
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