CONSORT Items | n | % | Lower 95% CI | Upper 95% CI | N |
---|---|---|---|---|---|
Title and Abstract | |||||
1a. Identification as a pilot or feasibility randomized trial in the title | 52 | 60.5% | 49.9% | 70.3% | 86 |
1b. Structured summary of pilot trial design, methods, results, and conclusions (for specific guidance see CONSORT abstract extension for pilot trials) | 79 | 91.9% | 84.7% | 96.3% | 86 |
Introduction | |||||
2a. Scientific background and explanation of rationale for future definitive trial, and reasons for randomized pilot trial | 23 | 26.7% | 18.3% | 36.8% | 86 |
2b. Specific objectives or research questions for pilot trial | 84 | 97.7% | 92.7% | 99.5% | 86 |
Methods | |||||
Trial design | |||||
3a. Description of pilot trial design (such as parallel, factorial) including allocation ratio | 36 | 41.9% | 31.8% | 52.4% | 86 |
3b. Important changes to methods after pilot trial commencement (such as eligibility criteria), with reasons | 5 | 5.8% | 2.3% | 12.3% | 86 |
Participants | |||||
4a. Eligibility criteria for participants | 80 | 93.0% | 86.2% | 97.0% | 86 |
4b. Settings and locations where the data were collected | 57 | 66.3% | 55.9% | 75.6% | 86 |
4c. How participants were identified and consented | 58 | 67.4% | 57.1% | 76.6% | 86 |
Interventions | |||||
5. The interventions for each group with sufficient details to allow replication, including how and when they were actually administered | 74 | 86.0% | 77.6% | 92.1% | 86 |
Outcome measurement | |||||
6a. Completely defined prespecified assessments or measurements to address each pilot trial objective specified in 2b, including how and when they were assessed | 79 | 91.9% | 84.7% | 96.3% | 86 |
6b. Any changes to pilot trial assessments or measurements after the pilot trial commenced, with reasons | 3 | 3.5% | 1.0% | 9.0% | 86 |
6c. If applicable, prespecified criteria used to judge whether, or how, to proceed with future definitive trial* | 7 | 9.0% | 4.1% | 16.8% | 78 |
Sample size | |||||
7a. Rationale for numbers in the pilot trial | 24 | 27.9% | 19.3% | 38.0% | 86 |
7b. When applicable, explanation of any interim analyses and stopping guidelines* | 3 | 7.9% | 2.3% | 19.6% | 38 |
Randomization | |||||
8a. Method used to generate the random allocation sequence | 30 | 34.9% | 25.4% | 45.3% | 86 |
8b. Type of randomization(s); details of any restriction (such as blocking and block size) | 24 | 27.90% | 19.3% | 38.0% | 86 |
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 | 22 | 25.60% | 17.3% | 35.5% | 86 |
Implementation | |||||
10. Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions | 16 | 18.60% | 11.5% | 27.8% | 86 |
Blinding | |||||
11a. If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how* | 33 | 43.40% | 32.7% | 54.6% | 76 |
11b. If relevant, description of the similarity of interventions* | 20 | 71.40% | 53.2% | 85.5% | 28 |
Statistical methods | |||||
12. Methods used to address each pilot trial objective whether qualitative or quantitative | 84 | 97.70% | 92.7% | 99.5% | 86 |
Results | |||||
Participant flow | |||||
13a. For each group, the numbers of participants who were approached and/or assessed for eligibility, randomly assigned, received intended treatment, and were assessed for each objective | 62 | 72.10% | 62.0% | 80.7% | 86 |
13b. For each group, losses and exclusions after randomization, together with reasons | 66 | 76.70% | 67.0% | 84.7% | 86 |
Recruitment | |||||
14a. Dates defining the periods of recruitment and follow-up | 37 | 43.00% | 32.9% | 53.6% | 86 |
14b. Why the pilot trial ended or was stopped | 8 | 9.30% | 4.5% | 16.8% | 86 |
Baseline data | |||||
15. A table showing baseline demographic and clinical characteristics for each group | 72 | 83.70% | 74.9% | 90.4% | 86 |
Numbers analyzed | |||||
16. For each objective, number of participants (denominator) included in each analysis. If relevant, these numbers should be by randomized group | 39 | 45.30% | 35.1% | 55.9% | 86 |
Outcomes and estimation | |||||
17. For each objective, results including expressions of uncertainty (such as 95% confidence interval) for any estimates. If relevant, these results should be by randomized group | 70 | 81.40% | 72.2% | 88.5% | 86 |
Ancillary analyses | |||||
18. Results of any other analyses performed that could be used to inform the future definitive trial* | 13 | 21.30% | 12.5% | 32.8% | 61 |
Harms | |||||
19. All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) | 48 | 55.80% | 45.3% | 66.0% | 86 |
19a. If relevant, other important unintended consequences* | 19 | 27.90% | 18.4% | 39.4% | 68 |
Discussion | |||||
Limitations | |||||
20. Pilot trial limitations, addressing sources of potential bias and remaining uncertainty about feasibility | 63 | 73.30% | 63.2% | 81.7% | 86 |
Generalisability | |||||
21. Generalisability (applicability) of pilot trial methods and findings to future definitive trial and other studies | 38 | 44.20% | 34.0% | 54.7% | 86 |
Interpretation | |||||
22. Interpretation consistent with pilot trial objectives and findings, balancing potential benefits and harms, and considering other relevant evidence | 84 | 97.70% | 92.7% | 99.5% | 86 |
22a. Implications for progression from pilot to future definitive trial, including any proposed amendments | 14 | 16.30% | 9.6% | 25.1% | 86 |
Other information: Registration | |||||
23. Registration number for pilot trial and name of trial registry | 27 | 31.40% | 22.3% | 41.7% | 86 |
Protocol | |||||
24. Where the pilot trial protocol can be accessed, if available | 7 | 8.10% | 3.7% | 15.3% | 86 |
Funding | |||||
25. Sources of funding and other support (such as supply of drugs), role of funders | 61 | 70.90% | 60.8% | 79.7% | 86 |
26. Ethical approval or approval by research review committee, confirmed with reference number | 53 | 61.60% | 51.1% | 71.4% | 86 |