|
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)
| |
