Table 2. Summary of protocol completeness assessment for each sub-item of the SPIRIT# checklist (n=126).
| Item NO. |
No. of protocols assessed as | ||||
|---|---|---|---|---|---|
| Score 2* | Score 1* | Score 0* | N/A* | ||
| Administrative information | |||||
| Title | 1 | 100 (79.4%) | 20 (15.9%) | 6 (4.8%) | 0 |
| Trial registration | 2a | 2 (1.6%) | 23 (18.3%) | 101 (80.2%) | 0 |
| 2b | 1 (0.8%) | 23 (18.3%) | 102 (81.0%) | 0 | |
| Protocol version | 3 | 20 (15.9%) | 16 (12.7%) | 90 (71.4%) | 0 |
| Funding | 4 | 13 (10.3%) | 2 (1.6%) | 111 (88.1%) | 0 |
| Roles and responsibilities | 5a | 29 (23.0%) | 28 (22.2%) | 69 (54.8%) | 0 |
| 5b | 38 (30.2%) | 19 (15.1%) | 69 (54.8%) | 0 | |
| 5c | 2 (1.6%) | 4 (3.2%) | 120 (95.2%) | 0 | |
| 5d | 1 (0.8%) | 2 (1.6%) | 123 (97.6%) | 0 | |
| Introduction | |||||
| Background and rationale | 6a | 96 (76.2%) | 16 (12.7%) | 14 (11.1%) | 0 |
| 6b | 57 (45.2%) | 36 (28.6%) | 31 (24.6%) | 2 (1.6%) | |
| Objectives | 7 | 111 (88.1%) | 7 (5.6%) | 8 (6.3%) | 0 |
| Trial design | 8 | 76 (60.3%) | 23 (18.3%) | 26 (20.6%) | 0 |
| Methods: Participants, interventions, and outcomes | |||||
| Study setting | 9 | 83 (65.9%) | 4 (3.2%) | 39 (31.0%) | 0 |
| Eligibility criteria | 10 | 112 (82.4%) | 8 (6.3%) | 6 (4.8%) | 0 |
| Interventions | 11a | 105 (83.3%) | 11 (8.7%) | 10 (7.9%) | 0 |
| 11b | 29(23.0%) | 9 (7.1%) | 88 (69.8%) | 0 | |
| 11c | 6 (4.8%) | 3 (2.4%) | 117 (92.9%) | 0 | |
| 11d | 5 (4.0%) | 5 (4.0%) | 116 (92.1%) | 0 | |
| Outcomes | 12 | 111 (88.1%) | 12 (9.5%) | 3 (2.4%) | 0 |
| Participant timeline | 13 | 34 (27.0%) | 1 (0.8%) | 91 (72.2%) | 0 |
| Sample size | 14 | 28 (22.2%) | 60 (47.6%) | 38 (30.2%) | 0 |
| Recruitment | 15 | 15 (11.9%) | 29 (23.0%) | 82 (65.1%) | 0 |
| Methods: Assignment of interventions (for controlled trials) | |||||
| Allocation: | |||||
| Sequence generation | 16a | 30 (23.8%) | 21 (16.7%) | 69 (54.8%) | 6(4.8%) |
| Allocation concealment mechanism | 16b | 11 (8.7%) | 15 (11.9%) | 92 (73.0%) | 8(6.3%) |
| Implementation | 16c | 4 (3.2%) | 12 (9.5%) | 103 (81.7%) | 7(5.6%) |
| Blinding | 17a | 20 (15.9%) | 8(6.3%) | 33 (26.2%) | 65 (51.6%) |
| 17b | 6 (4.8%) | 1 (0.8%) | 54 (42.9%) | 65 (51.6%) | |
| Methods: Data collection, management and analysis | |||||
| Data collection methods | 18a | 11 (8.7%) | 31 (24.6%) | 84 (66.7%) | 0 |
| 18b | 3 (2.4%) | 7(5.6%) | 116 (92.1%) | 0 | |
| Data management | 19 | 8 (6.3%) | 4 (3.2%) | 114 (90.5%) | 0 |
| Statistical methods | 20a | 59 (46.8%) | 13 (10.3%) | 54 (42.9%) | 0 |
| 20b | 6(4.8%) | 8 (6.3%) | 112 (88.9%) | 0 | |
| 20c | 3 (2.4%) | 4 (3.2%) | 119 (94.4%) | 0 | |
| Methods: Monitoring | |||||
| Data monitoring | 21a | 6(4.8%) | 2 (1.6%) | 118 (93.7%) | 0 |
| 21b | 3 (2.4%) | 1 (0.8%) | 122 (96.8%) | 0 | |
| Harms | 22 | 33 (26.2%) | 10 (7.9%) | 83 (65.9%) | 0 |
| Auditing | 23 | 1 (0.8%) | 1 (0.8%) | 124 (98.4%) | 0 |
| Ethics and dissemination | |||||
| Research ethics approval | 24 | 61 (48.4%) | 10 (7.9%) | 55 (43.7%) | 0 |
| Protocol amendments | 25 | 10 (7.9%) | 2 (1.6%) | 114 (90.5%) | 0 |
| Consent or assent | 26a | 78 (61.9%) | 9 (7.1%) | 39 (31.0%) | 0 |
| 26b | 1 (0.8%) | 2 (1.6%) | 51 (40.5%) | 72 (57.1%) | |
| Confidentiality | 27 | 14 (11.1%) | 3 (2.4%) | 108 (85.7%) | 0 |
| Declaration of interests | 28 | 1 (0.8%) | 3 (2.4%) | 122 (96.8%) | 0 |
| Access to data | 29 | 7 (5.6%) | 5 (4.0%) | 114 (90.5%) | 0 |
| Ancillary and post-trial care | 30 | 4 (3.2%) | 4 (3.2%) | 118 (93.7%) | 0 |
| Dissemination policy | 31a | 4 (3.2%) | 3 (2.4%) | 119 (94.4%) | 0 |
| 31b | 0 | 2 (1.6%) | 124 (98.4%) | 0 | |
| 31c | 0 | 1 (0.8%) | 125 (99.2%) | 0 | |
| Appendices | |||||
| Informed consent materials | 32 | 3 (2.4%) | 0 | 123 (97.6%) | 0 |
| Biological specimen | 33 | 1 (0.8%) | 0 | 49 (38.9%) | 76(60.3%) |
# SPIRIT: Standard Protocol Items: Recommendations for Intervention Trials. *A score of 2 indicated that all important information was adequately reported in the protocol for that sub-item; a score of 1 indicated that some important information was inadequately reported; a score of 0 indicated that no information related to the sub-item was reported. N/A indicated that the item was not applicable to the specific protocol.