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Specifically, for trials this included randomization, allocation concealment, intention to treat analysis and completeness of follow up.
Small and large trials were compared in methodological qualities including sequence generating, blinding, allocation concealment, intention to treat and sample size calculation.
The data on the methodological quality (allocation concealment, intention to treat analysis and Jadad score) of the trials were collected using a standardized data extraction form.
The internet-based trial of the CAM fulfilled the revised CONSORT statement such as efficient blinding, allocation concealment, intention to treat analysis and flow of participants through the trial.
We assessed trial quality by evaluating randomisation and allocation concealment, intention to treat analysis, blinded assessment of outcome measures, premature stopping of patient enrolment, and reporting about dropouts, but without using a quality score given limitations inherent to such an approach (see web extra table 3).
Six reviewers (BON, CH, DSL, JH, MT and PJG) then recorded the presence or absence of the following elements of critical appraisal: a clear hypothesis, control group, power calculation, randomisation, allocation concealment, intention to treat, blinding (investigator and/or subjects) and sports outcome (subjective or objective) that demonstrates improved performance or recovery.
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The overall methodological quality was adequate with regard to randomisation, allocation concealment, intention-to-treat analysis, and completeness of follow-up.
Future studies should ensure rigorous methodology and reporting, mainly adequate sample size, adequate randomization, allocation concealment, intention-to treat analysis, and blinding of at least outcome assessors [ 50].
The variables considered included, for example, location of the study, setting, study design, blinding assessment, allocation concealment, intention-to-treat analysis, lost to follow-up rates, intervention and control group definitions and study limitations.
The study was designed to be performed using optimised methodological resources such as an online randomisation system that ensures allocation concealment, intention-to-treat analysis of data and blinded adjudication of clinical events, in order to prevent systematic bias.
A specific data extraction form was designed for assessment of quality features of studies, such as randomization, allocation concealment, intention-to-treat principle, similarity of treatment arms according to known prognostic factors, follow up and drop-outs [ 22, 23].
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