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Table 2 Details of adjusted analysis

From: Reporting on covariate adjustment in randomised controlled trials before and after revision of the 2001 CONSORT statement: a literature review

Year of publication

2000

(n = 84)*

2006

(n = 113)*

% difference

(95% CI)

P-value

Performed adjusted analysis on primary outcome†

50 (90.9%)

93 (93.9%)

30.0 (-5.9 to 12.0)

0.5

Reason for adjustment

   

0.4

   Imbalance in covariates

9 (10.7%)

12 (10.6%)

  

   Prognostic covariates

6 (7.1%)

15 (13.3%)

  

   Both

0

3 (2.6%)

  

   Other reasons ‡

3 (3.6%)

4 (3.5%)

  

   Not mentioned

66 (78.6%)

79 (69.9%)

  

Choice of covariates

   

0.5

   All pre-specified

5 (5.9%)

8 (7.1%)

  

   All suggested by data

12 (14.3%)

20 (17.7%)

  

   Combination of pre-specified and post hoc

0

3 (2.6%)

  

   Not mentioned

67 (79.8%)

82 (72.6%)

  

Number of covariates adjusted for §

   

0.02 ||

   1

39 (46.4%)

36 (31.8%)

  

   2

23 (27.4%)

33 (29.2%)

  

   3-5

14 (16.7%)

25 (22.1%)

  

   6-9

2 (2.4%)

12 (10.6%)

  

   Not mentioned

6 (7.1%)

7 (6.2%)

  

Covariate used for adjustment

    

   Outcome assessed at baseline

33/62 (53.2%)

55/81 (67.9%)

14.7 (-1.4 to 30.7)

0.07

   Centre/Country

31/49 (63.3%)

25/61 (41.0%)

-22.3 (-40.6 to -39.9)

0.02

   Assessed after randomisation

9/78 (11.8%)

9/107 (8.4%)

-3.1 (-12.0 to 5.7)

0.5

All stratification factors were adjusted for

11/25 (44.0%)

20/46 (43.5%)

-0.5 (-24.7 to 23.6)

1.0

Explicitly specified nature of analysis

    

   Primary analysis

2

5

  

   Secondary/sensitivity analysis

5

5

  

Type of outcomes

   

0.8

   Binary

13 (15.5%)

19 (16.8%)

  

   Continuous

65 (77.4%)

81 (71.7%)

  

   Ordinal

1 (1.2%)

3 (2.6%)

  

   Time-to-event

5 (5.9%)

10 (8.9%)

  

Adjusted analysis method used was mentioned for specific outcome in the Method section

62/78 ¶(79.5%)

88/109 ¶ (80.7%)

1.2 (-10.4 to 12.9)

0.8

  1. *One adjusted analysis selected per study only
  2. †Number of studies that have specified primary outcomes: Year 2000 = 55 and Year 266 = 99
  3. ‡Year 2000: Clinical relevance (n = 1), significant at 3 weeks after randomisation (n = 1), exploring role of baseline variables (n = 1); Year 2006: Mediated treatment effect on outcome (n = 1), related to compliance/adherence of treatment (n = 2), effect of outcome decline over time (n = 1)
  4. §Year 2000: 6 studies did not report number of covariates; Year 2006: 6 studies did not report number of covariates and 1 stated at least 2 covariates
  5. || Mann-Whitney test
  6. ¶Did not have statistical method section: Year 2000 (n = 6), Year 2006 (n = 5)