Recommendationsa | |
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1. Conduct a comprehensive review of the literature to identify the MCID. If the RCT is completely novel, use preliminary pilot data to inform the MCID | |
2. Perform a sample size calculation using a delta value that is based on the MCID. If the sample size is not feasible given resource constraints, adjust the delta value to increase the sample size to a value that is still clinically meaningful | |
3. When reporting the results of an RCT ensure the following are reported in the sample size calculation: • Type 1 error (α value)  ○ One- or two-sided p value • Type 2 error (β value)  ○ At least 80% is recommended • Estimated controlled value and justification • Estimated experimental value and justification • Delta value in absolute terms and justification of treatment effect • Explicitly identify primary outcome when multiple outcomes are being investigated | |
4. Calculate and report confidence intervals for the experimental and controlled values as well as the treatment effect | |
5. Interpret the treatment effect and its confidence interval in relation to the MCID and place weight on conclusions based on the precision determined by the confidence interval | |
6. Ensure conclusions reflect the quality of the trial based on the recommendations of the CONSORT Statement |