Jakobsen et al. | |||
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Criteria | Yes | No | Other (CD, NR, NA)* |
1. Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT? | ☑ | ||
2. Was the method of randomization adequate (i.e., use of randomly generated assignment)? | ☑ | ||
3. Was the treatment allocation concealed (so that assignments could not be predicted)? | ☑ | ||
4. Were study participants and providers blinded to treatment group assignment? | ☑ | ||
5. Were the people assessing the outcomes blinded to the participants’ group assignments? | ☑ | ||
6. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, and comorbid conditions)? | ☑ | ||
7. Was the overall dropout rate from the study at endpoint 20% or lower of the number allocated to treatment? | ☑ | ||
8. Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower? | ☑ | ||
9. Was there high adherence to the intervention protocols for each treatment group? | ☑ | ||
10. Were other interventions avoided or similar in the groups (e.g., similar background treatments)? | ☑ | ||
11. Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants? | ☑ | ||
12. Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power? | ☑ | ||
13. Were outcomes reported or subgroups analyzed pre-specified (i.e., identified before analyses were conducted)? | ☑ | ||
14. Were all randomized participants analyzed in the group to which they were originally assigned, that is, did they use an intention-to-treat analysis? | ☑ |
CD: Cannot determine, NA: Not applicable, NR: Not reported