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Randomised controlled trials (RCTs) which involve cost-effectiveness evaluations rarely use health economic input when undertaking sample size calculations for the trial design; however, in studies undertaken with cost-effectiveness as the primary outcome, sample size calculations should be directly related to the cost-effectiveness result rather than to the effectiveness outcome alone.
For the generation of alerts outcome, sample size was sufficient to include all variables in the multivariate model using alternating logistic regression.
However, no more than 30% of included reports presented the primary and second outcome, sample size calculation and outcome estimation, etc.
Methodological items were use of the term "randomised" in the study title and specification of the primary outcome, sample size calculation, method of random sequence generation and allocation concealment, who was blinded, and how blinding was achieved.
Data extracted for the host trial were aim, setting, disease area, comparators, primary outcome, sample size calculation, inclusion exclusion criteria, sequence generation and allocation concealment, and numbers randomised to each group.
For each outcome: Sample size; missing participants; adjusted/unadjusted effect estimates (RRs/ORs/HRs) and their SEs/CIs; subgroup analyses; covariates (if estimates adjusted for covariates (such as systematic disorders and PS), write them down).
Similar(49)
We evaluated the adequacy of randomization and concealment, blinding, reporting of outcomes, sample size calculation, and disclosure of funding sources.
Based on this study's primary feasibility and preliminary efficacy outcomes, sample size was based on resources available.
Retention trials were often poorly reported without consort diagrams, clear primary outcomes, sample size, sociodemographic composition or power calculations.
Poor reporting existed in terms of "outcomes", "sample size", "outcomes and estimation", "ancillary analyses" with positive rate of less than 30% (Table 1).
Differences between primary and secondary outcomes, sample size and sample size calculations data in http://ClinicalTrials.gov and in the published paper were registered.
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