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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)