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Table 3 Quality of reporting of SW-CRCTs (N = 39)

From: Stepped wedge cluster randomized controlled trial designs: a review of reporting quality and design features

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)  
  1. Indicators listed in bold are those contained in the CONSORT extension to CRCTs. Indicators listed in italics are those contained in the chosen subset of 10 key criteria. The two criteria marked with a * are out of 25 records rather than 39, since secondary outcomes were not present in every trial. An overall median raw mark, and median raw mark on the CONSORT criteria are consequently not calculable