Table 2 Adherence of papers to CONSORT Harms 2022 checklist by study and item. 1 = adequately reported, 0 = inadequately or not reported at all.
From: Side-effects of mdma-assisted psychotherapy: a systematic review and meta-analysis
CONSORT item | Study | Adherence of trials, n (%) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
Bouso 2011 | Danforth 2018 | Mitchell 2021 | Mitchell 2023 | Mithoefer 2018 | Mithoefer 2011 | Oehen 2013 | Ot’alora 2018 | |||
Title and abstract | Item 1b: Structured summary of trial design, methods, results of outcomes of benefits and harms, and conclusions (for specific guidance see CONSORT for abstracts). | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 7/8 (88%) |
Introduction | Item 2b: Specific objectives or hypotheses for outcomes of benefits and harms. | 1 | 1 | 1 | 0 | 1 | 1 | 1 | 0 | 6/8 (75%) |
Methods | Item 6a: Completely defined prespecified primary and secondary outcomes, for both benefits and harms, including how and when they were assessed. | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 3/8 (38%) |
Item 6b: Any changes to trial outcomes after the trial commenced, with reasons. | 1 | n/a | n/a | n/a | n/a | n/a | n/a | n/a | 1/1 (100%) | |
Item 6c: Describe if and how non-prespecified outcomes of benefits and harms were identified, including any selection criteria, if applicable. | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | |
Item 11a: If done, who was blinded after assignment to interventions (eg, participants, care providers, those assessing outcomes of benefits and harms) and how. | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 7/8 (88%) | |
Item 12a: Statistical methods used to compare groups for primary and secondary outcomes of both benefits and harms. | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 2/8 (25%) | |
Results | Item 13a: For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for outcomes of benefits and harms. | 0 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 6/8 (75%) |
Item 14a: Dates defining the periods of recruitment and follow-up for outcomes of benefits and harms. | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 1 | 6/8 (75%) | |
Item 16: For each group, number of participants (denominator) included in each analysis of outcomes of benefits and harms and whether the analysis was by original assigned groups and if any exclusions were made. | 0 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 6/8 (75%) | |
Item 17a: For each primary and secondary outcomes of benefits and harms, results for each group, and the estimated effect size and its 0precision (such as 95% confidence intervals). | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0/8 (0%) | |
It0em 17a2: For outcomes omitted from the trial report (benefits and harms), provide rationale for not reporting and indicate where the data on omitted outcomes can be accessed. | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1/8 (13%) | |
Item 17b: Presentation of both absolute and relative effect sizes is recommended for outcomes of benefits and harms. | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0/8 (0%) | |
Item 17c: Report zero events if no harms were observed. | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1/8 (13%) | |
Item 18: Results of any other analyses performed for outcomes of benefits and harms, including subgroup analyses and adjusted analyses, distinguishing prespecified from exploratory. | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | |
Discussion | Item 20: Trial limitations, addressing sources of potential bias related to the approach to collecting or reporting data on harms, imprecision, and, if relevant, multiplicity or selection of analyses. | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 2/8 (25%) |
Other information | Item 24: Where the full trial protocol and other relevant documents can be accessed, including additional data on harms. | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 7/8 (88%) |
Total | 7 | 8 | 8 | 9 | 7 | 6 | 3 | 7 | ||
Adherence (%) | 47 | 57 | 57 | 64 | 50 | 43 | 21 | 50 | ||
