|
| Paper section & topic | Item | Reporting criterion | Numbera (%) |
|
| Title & Abstract | 1-1 | Does the title identify the report as a RCT? | 20 (65) |
| 1-2 | Does the abstract have a structured format? | 27 (87) |
| Introduction | 2 | Do authors provide the scientific background and the scientific rationale for their report? | 31 (100) |
| Background | | | |
| Methods | 3-1 | Are eligibility (inclusion and/or exclusion) criteria provided? | 31 (100) |
| Participants | 3-2 | Do authors describe settings where the data were collected? | 9 (29) |
| Interventionsb | 4 | Are the precise details of interventions described?b | 7 (23) |
| Objectives | 5 | Are study objectives or hypotheses specified? | 29 (94) |
| Outcomes | 6-1 | Are outcome variables clearly defined? | 28 (90) |
| 6-2 | Are any particular methods used to enhance the quality of the measurements? | 13 (42) |
| Sample size | 7-1 | Do authors explain how the sample size was determined? | 13 (42) |
| 7-2 | Is attrition taken into account in the sample size calculation? | 7 (54)c |
| Randomization: Sequence generation | 8-1 | Is there a description of the method used to generate the random allocation sequence? | 15 (48) |
| 8-2 | Is there any restriction of randomization provided? | 14 (45) |
| Randomization: Allocation concealment | 9-1 | Is the method used to implement the random allocation sequence described? | 5 (16) |
| 9-2 | Do authors clarify whether the sequence was concealed until interventions were assigned? | 9 (29) |
| Randomization: Implementation | 10-1 | Do authors report who generated the allocation sequence? | 8 (26) |
| 10-2 | Do authors report who enrolled participants? | 7 (23) |
| 10-3 | Do authors report who assigned participants to their groups? | 7 (23) |
| Blinding (Masking) | 11 | Do author report whether or not outcome assessors were blinded to group assignment? | 14 (45) |
| Statistical methods | 12 | Is there a description of the statistical methods used to compare groups for outcome variables? | 29 (94) |
| Results | 13-1 | Is there a diagram showing participant flow in the trial? | 15 (48) |
| Participant flow | 13-2 | Do authors report the numbers of participants randomly assigned? | 20 (65) |
| 13-3 | Do authors report the numbers of participants receiving intended treatment? | 12 (40) |
| 13-4 | Do authors report the numbers of participants completing the study protocol? | 23 (74) |
| 13-5 | Do authors report the numbers of participants analyzed for the primary outcome? | 16 (52) |
| Recruitment | 14-1 | Is the period of recruitment defined including starting and ending dates? | 7 (23) |
| 14-2 | Is the period of follow-up defined including starting and ending dates? | 3 (10) |
| Baseline data | 15 | Are baseline demographic and clinical characteristics of each group presented? | 28 (90) |
| Numbers analyzed | 16-1 | Do authors report the numbers of participants in each group included in each analysis? | 19 (61) |
| 16-2 | Do author state that whether the analysis was by “intention-to-treat”? | 12 (39) |
| 16-3 | Are the results presented in absolute numbers? | 23 (77) |
| Outcomes and estimation | 17-1 | Is there a summary of results for each group? | 28 (90) |
| 17-2 | For each outcome variable, is the estimated effect size reported? | 26 (84) |
| 17-3 | For each outcome variable, is the effect size's precision (e.g., 95% confidence interval) reported? | 24 (77) |
| Ancillary analyses | 18 | Do authors report any other analyses performed including subgroup analyses and adjusted analyses, indicating those pre-specified and those exploratory? (e.g., adjusted P, post hoc or a posteriori) | 10 (32) |
| Adverse events | 19 | Is there any information on adverse events in each intervention group provided? | 12 (39) |
| Discussion | 20-1 | Do authors address study hypotheses/objectives in their interpretation of the results? | 30 (97) |
| Interpretation | 20-2 | Do authors describe sources of potential bias or imprecision in their interpretation of the results? | 26 (84) |
| Generalizability | 21 | Do authors discuss the generalizability (external validity) of the trial findings? | 14 (45) |
| Overall evidence | 22 | Do authors discuss the results in the context of current evidence? | 17 (58) |
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