Table 2 Details for guideline adherence of the included studies
Number of item | Checklist item | Guideline adherence | ||||
|---|---|---|---|---|---|---|
Overall studies (n = 50) | Subgroups# | |||||
By type of pilot trial | By year of publication | |||||
FDT (n = 12) | NFT (n = 38) | Studies published before 2016 (n = 38) | Studies published after 2016 (n = 12) | |||
Title and abstract | ||||||
 1a | Identification as a pilot or feasibility randomized trial in the title | 47 (94.0) | 11 (91.7) | 36 (94.7) | 36 (94.7) | 11 (91.7) |
 1b | Structured summary of pilot trial design, methods, results, and conclusions (for specific guidance see CONSORT abstract extension for pilot trials) | 37 (74.0) | 9 (75.0) | 28 (73.7) | 27 (71.1) | 10 (83.3) |
Introduction | ||||||
 2a | Scientific background and explanation of rationale for future definitive trial, and reasons for randomized pilot trial | 11 (22.0) | 3 (25.0) | 8 (21.1) | 8 (21.1) | 3 (25.0) |
 2b | Specific objectives or research questions for pilot trial | 9 (18.0) | 3 (25.0) | 6 (18.4) | 8 (15.8) | 1 (8.3) |
Methods | ||||||
 3a | Description of pilot trial design (such as parallel, factorial) including allocation ratio | 35 (70.0) | 8 (66.7) | 27 (71.1) | 26 (68.4) | 9 (75.0) |
 4c | How participants were identified and consented | 39 (78.0) | 9 (75.0) | 30 (79.0) | 29 (76.3) | 10 (83.3) |
 5 | The interventions for each group with sufficient details to allow replication, including how and when they were actually administered | 44 (88.0) | 10 (83.3) | 34 (89.5) | 34 (89.5) | 10 (83.3) |
 6a | Completely defined prespecified assessments or measurements to address each pilot trial objective specified in 2b, including how and when they were assessed | 44 (88.0) | 10 (83.3) | 34 (89.5) | 34 (89.5) | 10 (83.3) |
 6c | If applicable, prespecified criteria used to judge whether, or how, to proceed with future definitive trial | 2 (4.0) | 1 (8.3) | 1 (2.6) | 1 (2.6) | 1 (8.3) |
 7a | Rationale for numbers in the pilot trial | 4 (8.0) | 3 (25.0)* | 1 (2.6)* | 3 (7.9) | 1 (8.3) |
 12a | Methods used to address each pilot trial objective whether qualitative or quantitative | 48 (96.0) | 11 (91.7) | 37 (97.3) | 21 (55.3)* | 12 (100.0)* |
Results | ||||||
 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 | 34 (68.0) | 10 (83.3) | 24 (63.2) | 26 (68.4) | 8 (66.7) |
Discussion | ||||||
 20 | Pilot trial limitations, addressing sources of potential bias, and remaining uncertainty about feasibility | 33 (66.0) | 7 (58.3)* | 13 (34.2)* | 27 (71.1) | 6 (50.0) |
 21 | Generalizability (applicability) of pilot trial methods and findings to future definitive trial and other studies | 9 (18.0) | 3 (25.0) | 6 (15.8) | 7 (18.4) | 2 (16.7) |
 22a | Implications for progression from pilot to future definitive trial, including any proposed amendments | 31 (62.0) | 6 (50.0) | 25 (65.8) | 24 (63.2) | 7 (58.3) |