Table 3 Quality of reporting of SW-CRCTs (N = 39)
Heading/subheading | Criterion | Yes (%) | 95% confidence interval (%) |
|---|---|---|---|
Title and abstract | Phrase ‘step wedge’ or ‘stepped wedge’ used | 26 (66.7) | (51.0, 79.4) |
Phrase ‘randomized’ used | 29 (74.4) | (58.9, 85.4) | |
Introduction or methods | Rationale for stepped wedge design given | 25 (64.1) | (48.4, 77.3) |
Rationale for clustering given | 6 (15.4) | (7.2, 29.7) | |
Specific objectives of the trial given | 39 (100.0) | (91.0, 100.0) | |
Diagram of the design provided | 26 (66.7) | (51.0, 79.4) | |
Description of the trial design provided | 36 (92.3) | (79.7, 97.3) | |
Eligibility criteria for clusters provided | 25 (64.1) | (48.4, 77.3) | |
Eligibility criteria for individuals provided | 34 (87.2) | (73.3, 94.4) | |
Settings and locations where data collected adequately described | 39 (100.0) | (91.0, 100.0) | |
Interventions adequately described | 37 (94.9) | (83.1, 98.6) | |
Completely defined primary outcomes | 36 (92.3) | (29.3, 59.0) | |
Completely defined secondary outcomes* | 22 (95.7) | (79.0, 99.2) | |
Justification for sample size provided | 24 (61.5) | (45.9, 75.1) | |
Use or non-use of intracluster correlation coefficient or coefficient of variation stated | 17 (43.6) | (29.3, 59.0) | |
Type-I error rate used stated | 22 (56.4) | (41.0, 70.7) | |
Type-II error rate for design stated | 23 (59.0) | (43.4, 72.9) | |
Method of random allocation used | 23 (59.0) | (43.4, 72.9) | |
Type or randomization used | 36 (92.3) | (29.3, 59.0) | |
Allocation concealment mechanism used | 12 (30.8) | (18.6, 46.4) | |
Who implemented the randomization detailed | 15 (38.5) | (24.9, 54.1) | |
Consent sought from | 31 (79.5) | (64.5, 89.2) | |
Blinding adequately described | 20 (51.3) | (36.2, 66.1) | |
Results | Flow diagram provided | 24 (61.5) | (45.9, 75.1) |
Losses and exclusions detailed | 30 (76.9) | (61.7, 87.4) | |
Dates of the trial provided | 33 (84.6) | (70.3, 92.8) | |
Dates of each time period provided | 14 (35.9) | (22.7, 51.6) | |
Baseline data reported | 33 (84.6) | (70.3, 92.8) | |
Final number of clusters analyzed detailed | 39 (100.0) | (91.0, 100.0) | |
Final number of individuals analyzed detailed | 36 (92.3) | (29.3, 59.0) | |
Final number of steps detailed | 38 (97.4) | (86.8, 99.5) | |
Summary of outcomes provided | 39 (100.0) | (91.0, 100.0) | |
Point estimate and variation estimate of primary outcome measures provided | 32 (82.1) | (67.3, 91.0) | |
Point estimate and variation estimate of secondary outcome measures provided* | 15 (65.2) | (44.9, 81.2) | |
Intention-to-treat analysis used | 16 (41.0) | (27.1, 56.6) | |
Intracluster correlation coefficient or coefficient of variation value reported | 6 (15.4) | (7.2, 29.7) | |
Discussion | Potential harms detailed | 6 (15.4) | (7.2, 29.7) |
Generalizability of results described | 18 (46.2) | (31.6, 61.4) | |
Limitations of the trial described | 38 (97.4) | (86.8, 99.5) | |
Interpretation of the results provided | 39 (100.0) | (91.0, 100.0) | |
Trial registration provided or referenced | 17 (43.6) | (29.3, 59.0) | |
Trial protocol provided or referenced | 14 (35.9) | (22.7, 51.6) | |
Trial funding detailed | 37 (94.9) | (83.1, 98.6) | |
Overall median | – (66.7) |  | |
Boldface median (CONSORT) | – (80.8) |  | |
Italicized median (key) | 26 (66.7) | Â | |