Table 2.
Reporting quality of 2,447 included trials based on the CONSORT and CONSORT for NPT items
| Section/topic | Item number and description | Item present, n (%) |
|---|---|---|
| Title and abstract | 1a. Identification as a randomised trial in the title | 656 (26.8) |
| 1b. Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) | 2420 (98.9) | |
| 1b NPT. When applicable, report eligibility criteria for centers where the intervention is performed and for care providers | 1395 (57.0) | |
| 1b NPT. Report any important changes to the intervention delivered from what was planned | 543 (22.2) | |
| Introduction | ||
| Background and objectives | 2a. Scientific background and explanation of rationale | 2364 (96.7) |
| 2b. Specific objectives or hypotheses | 2395 (97.9) | |
| Methods | ||
| Trial design | 3a. Description of trial design (such as parallel, factorial) including allocation ratio | 77 (3.1) |
| 3a NPT. When applicable, how care providers were allocated to each trial group | 945 (38.6) | |
| 3b. Important changes to methods after trial commencement (such as eligibility criteria), with reasons | 1676 (68.5) | |
| Participants | 4a. Eligibility criteria for participants | 2400 (98.1) |
| 4a NPT. When applicable, eligibility criteria for centers and for care providers | 52 (2.1) | |
| 4b. Settings and locations where the data were collected | 2431 (99.3) | |
| Interventions | 5. Interventions for each group with sufficient details to allow replication, including how and when they were actually administered | See Table 3 |
| 5a NPT. Precise details of both the experimental treatment and comparator | See Table 3 | |
| 5b NPT. Description of the different components of the interventions and, when applicable, description of the procedure for tailoring the interventions to individual participants. | See Table 3 | |
| 5c NPT. Details of whether and how the interventions were standardized. | 943 (38.5) | |
| 5d NPT. Details of whether and how adherence of care providers to the protocol was assessed or enhanced | 121 (4.9) | |
| 5e NPT. Details of whether and how adherence of participants to interventions was assessed or enhanced | 7 (0.3) | |
| Outcomes | 6a. Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed | 1431 (58.5) |
| 6b. Any changes to trial outcomes after the trial commenced, with reasons | 4 (0.2) | |
| Sample size | 7a. How sample size was determined | 844 (34.5) |
| 7a NPT. When applicable, details of whether and how the clustering by care providers or centers was addressed | 3 (0.1) | |
| 7b. When applicable, explanation of any interim analyses and stopping guidelines | 10 (0.4) | |
| Sequence generation | 8a. Method used to generate the random allocation sequence | 652 (26.6) |
| 8b. Type of randomisation; details of any restriction (such as blocking and block size) | 78 (3.2) | |
| Allocation concealment mechanism | 9. Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned | 74 (3.0) |
| Implementation | 10. Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions | 46 (1.9) |
| Blinding | 11a. If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how | 2343 (95.7) |
| 11a NPT. If done, who was blinded after assignment to interventions (e.g., participants, care providers, those administering co-interventions, those assessing outcomes) and how | 27 (1.1) | |
| 11b. If relevant, description of the similarity of interventions | 23 (0.9) | |
| 11c NPT. If blinding was not possible, description of any attempts to limit bias | 12 (0.5) | |
| Statistical methods | 12a. Statistical methods used to compare groups for primary and secondary outcomes | 2373 (97.0) |
| 12a NPT. When applicable, details of whether and how the clustering by care providers or centers was addressed | 1 (0.04) | |
| 12b. Methods for additional analyses, such as subgroup analyses and adjusted analyses | 10 (0.4) | |
| Results | ||
| Participant flow (a diagram is strongly recommended) | 13a. For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome | 2440 (99.7) |
| 13a NPT. The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider or in each center | 3 (0.1) | |
| 13b. For each group, losses and exclusions after randomisation, together with reasons | 2441 (99.8) | |
| 13c NPT. For each group, the delay between randomization and the initiation of the intervention | 2 (0.1) | |
| Recruitment | 14a. Dates defining the periods of recruitment and follow-up | 2376 (97.1) |
| 14b. Why the trial ended or was stopped | 2367 (96.7) | |
| Baseline data | 15. A table showing baseline demographic and clinical characteristics for each group | 324 (13.2) |
| 15 NPT. When applicable, a description of care providers (case volume, qualification, expertise, etc.) and centers (volume) in each group | 4 (0.2) | |
| Numbers analysed | 16. For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups | 2336 (95.5) |
| Outcomes and estimation | 17a. For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) | 2319 (94.8) |
| 17b. For binary outcomes, presentation of both absolute and relative effect sizes is recommended | 2183 (89.2) | |
| Ancillary analyses | 18. Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory | 8 (0.3) |
| Harms | 19. All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) | 148 (6.0) |
| Discussion | ||
| Limitations | 20. Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses | 117 (4.8) |
| 20 NPT. In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care providers or centers in each group | 10 (0.4) | |
| Generalisability | 21. Generalisability (external validity, applicability) of the trial findings | 2185 (89.3) |
| 21 NPT. Generalizability (external validity) of the trial findings according to the intervention, comparators, patients, and care providers and centers involved in the trial | 3 (0.1) | |
| Interpretation | 22. Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence | 2308 (94.3) |
| Other information | ||
| Registration | 23. Registration number and name of trial registry | 57 (2.3) |
| Protocol | 24. Where the full trial protocol can be accessed, if available | 38 (1.6) |
| Funding | 25. Sources of funding and other support (such as supply of drugs), role of funders | 495 (20.2) |