Table 2 Reporting of methodological aspect of included studies
From: Reporting of factorial trials of complex interventions in community settings: a systematic review
Year of Publication | 2000-2003 | 2004-2009 | Total | ||||||
|---|---|---|---|---|---|---|---|---|---|
Number of Trials | 27 | 49 | 76 | ||||||
Heading | Subheading | Methodological Descriptor | Frequency | Percent | Frequency | Percent | Frequency | Percent | |
Title and abstract | Phrase "factorial" used | No | 2 | (7) | 4 | (8) | 6 | (8) | |
Yes | 25 | (93) | 45 | (92) | 70 | (92) | |||
Introduction | Background | Rationale for factorial trial established | Efficiency | 3 | (11) | 4 | (8) | 7 | (9) |
Interaction | 0 | (0) | 2 | (4) | 2 | (3) | |||
Both | 4 | (15) | 3 | (6) | 7 | (9) | |||
Not stated | 20 | (74) | 40 | (82) | 60 | (79) | |||
Methods | Design | Number of treatments | 2 × 2 | 24 | (89) | 43 | (88) | 67 | (88) |
Other | 3 | (11) | 6 | (12) | 9 | (12) | |||
Allocation | Units of allocation | Individual only | 20 | (74) | 28 | (57) | 48 | (63) | |
Cluster only | 5 | (19) | 16 | (33) | 21 | (28) | |||
Mixed | 2 | (7) | 5 | (10) | 7 | (9) | |||
Adequate description of randomisation (generation of sequence, execution) | No | 12 | (44) | 24 | (49) | 36 | (47) | ||
Yes | 15 | (56) | 25 | (51) | 40 | (53) | |||
Adequate allocation concealment | No | 1 | (4) | 2 | (4) | 3 | (4) | ||
Yes | 10 | (37) | 21 | (43) | 31 | (41) | |||
Unclear | 16 | (59) | 26 | (53) | 42 | (55) | |||
Sample size | Sample size calculation given | No | 10 | (37) | 13 | (27) | 23 | (30) | |
Yes | 17 | (63) | 36 | (73) | 53 | (70) | |||
If yes, estimates based on analysis: | At the margins | 11 | (65) | 27 | (75) | 38 | (71) | ||
Interaction/Inside the table | 1 | (6) | 4 | (11) | 5 | (10) | |||
Unclear/Inadequate | 5 | (29) | 5 | (14) | 10 | (19) | |||
Statistical methods | Analytical approach | ITT | 14 | (52) | 38 | (78) | 52 | (68) | |
Not explicitly stated | 13 | (48) | 11 | (22) | 24 | (32) | |||
Primary analysis correctly adjusted for design variables/baseline | No | 2 | (7) | 2 | (4) | 4 | (5) | ||
Yes | 22 | (81) | 39 | (80) | 61 | (80) | |||
Unclear | 3 | (11) | 8 | (16) | 11 | (15) | |||
For cluster allocations, appropriate analysis used | No | 2 | (29) | 3 | (14) | 5 | (18) | ||
Yes | 5 | (71) | 17 | (81) | 22 | (79) | |||
Unclear | 0 | (0) | 1 | (5) | 1 | (4) | |||
Results | Participant flow | Reported numbers randomly assigned and followed up | CONSORT diagram | 15 | (56) | 33 | (67) | 48 | (63) |
No diagram but adequate text | 3 | (11) | 2 | (4) | 5 | (7) | |||
Inadequate | 9 | (33) | 14 | (29) | 23 | (31) | |||
Baseline characteristics | Baseline data reported in table for treatment groups | No | 5 | (19) | 7 | (14) | 12 | (16) | |
Yes | 22 | (81) | 42 | (86) | 64 | (84) | |||
If yes, data reported: | At margins | 3 | (14) | 10 | (24) | 13 | (20) | ||
Inside the table | 17 | (77) | 29 | (69) | 46 | (72) | |||
Both | 2 | (9) | 3 | (7) | 5 | (8) | |||
Primary analyses | Descriptive data provided at follow up (eg mean & SD, N & %) | No | 2 | (7) | 7 | (14) | 9 | (12) | |
Yes | 25 | (93) | 42 | (86) | 67 | (88) | |||
If yes, data reported: | At margins | 8 | (32) | 13 | (31) | 21 | (31) | ||
Inside the table | 8 | (32) | 18 | (43) | 26 | (39) | |||
Both | 9 | (36) | 11 | (26) | 20 | (30) | |||
Appropriate between-group estimate(s) | No | 10 | (37) | 6 | (12) | 16 | (21) | ||
Yes | 17 | (63) | 43 | (88) | 60 | (79) | |||
SE or 95% CI reported | No | 12 | (44) | 11 | (22) | 23 | (30) | ||
Yes | 15 | (56) | 38 | (78) | 53 | (70) | |||
Interaction | Results of interaction reported | No | 7 | (26) | 16 | (33) | 23 | (30) | |
Yes | 20 | (74) | 33 | (67) | 53 | (70) | |||
If yes, level of detail reported: | No interaction found/p-value only | 17 | (85) | 22 | (67) | 39 | (74) | ||
Interaction estimate & SE/CI/p-value | 3 | (15) | 11 | (33) | 14 | (26) | |||
Discussion | Interaction | If interaction reported, was it discussed | No | 10 | (50) | 11 | (33) | 21 | (40) |
Yes | 10 | (50) | 22 | (67) | 32 | (60) | |||
Overall interpretation | Appropriate based on data presented | No | 4 | (15) | 0 | (0) | 4 | (5) | |
Yes | 23 | (85) | 49 | (100) | 72 | (95) | |||