| Objectives |
| 1. Are the objectives of the research adequate, ethical, realistic, and detailed enough for the readers and reviewers to comprehend? |
| 2. Is the research hypothesis stated clearly? |
| Design of the Study |
| 1-1. Are there adequate explanations of the research design parallel, crossover, and factorial design? |
| 1-2. Is the research design suitable for achieving the objectives? Is a concurrent control group used? |
| 2-1. Are the eligibility criteria, inclusion-exclusion criteria, and accessible population specified clearly? |
| 2-2. Does the author state the location, time, and environment of the data collection? |
| 3. Is the sampling method specified? |
| 4. Does the sample adequately represent the study population? (Is there external validity or consideration of external validity?) |
| 5. Are there grounds for statistical power or sample size calculation? |
| 6-1. Is the randomization explained? |
| 6-2. Is the sequence generation method explained? (E.g., whether the application of block or who conducted the sequence generation.) |
| 7. Is the allocation concealment method explained? |
| 8-1. Does the research employ blindness and give explanations? |
| 8-2. Is the blindness acceptable? |
| 9-1. Is an accurate list of variables provided? Are the variables of interest clearly defined? |
| 9-2. Are there explanations of the variables that are rarely used? |
| Commencement of Trial |
| 1-1. Does the paper describe the interventions applied to the compared groups and details them, including the time and method, to the extent that other researchers can reproduce them? |
| 1-2. Is the method used to measure the results clearly explained? |
| 2. Are the differences between the research proposal and the actual result mentioned? |
| 3. Does the paper report the side effects, reactions and harm variables? |
| 4. Is information about the patients who dropped out from the treatment group and the control group included? Is the follow-up rate high? |
