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Table 2 Proportion of reporting of CONSORT items in randomised controlled trials in periods pre- (1990–1994) and post-CONSORT (2004–2008)

From: Improvement of quality of reporting in randomised controlled trials to prevent hypotension after spinal anaesthesia for caesarean section

Data items

Combined

Pre-CONSORT

Post-CONSORT

Odds ratio (95% CI)

p value

Title and abstract

Randomised

1.0 (37)

1.0 (13)

1.0 (24)

 

1.0

Introduction

Scientific background

1.0 (37)

1.0 (13)

1.0 (24)

 

1.0

Eligibility criteria for participants

1.0 (37)

1.0 (13)

1.0 (24)

 

1.0

Details of Intervention

1.0 (37)

1.0 (13)

1.0 (24)

 

1.0

Objectives

1.0 (37)

1.0 (13)

1.0 (24)

 

1.0

Endpoints

0.89 (33)

0.77 (10)

0.96 (23)

6.9 (0.69; 74.51)

0.115

Sample size

0.54 (20)

0.23 (3)

0.71 (17)

8.1 (1.70; 38.58)

0.007

Methods of randomization

0.70 (26)

0.38 (5)

0.88 (21)

11.2 (2.11; 58.37)

0.003

Allocation concealment

0.57 (21)

0.38 (5)

0.67 (16)

3.2 (1.17; 8.74)

0.096

Implementation of randomization

0.41 (15)

0.08 (1)

0.58 (14)

16.8 (1.87; 150.73)

0.003

Blinding

0.65 (24)

0.31(4)

0.8 (20)

11.25 (2.29; 55.35)

0.0023

Statistical methods

0.89 (33)

0.69 (9)

1.0 (24)

 

0.011

Results

Participant flow

0.91 (34)

0.77 (10)

1.0 (24)

 

0.037

Recruitment + follow-up

0.51 (19)

0.61 (8)

0.46 (11)

0.53 (0.13; 2.10)

0.895

Baseline data

0.95 (35)

0.85 (11)

1.0 (24)

 

0.12

Intention-to-treat analysis

0.92 (34)

0.76 (10)

1.0 (24)

 

0.037

Outcome and estimation

0.95 (35)

0.85 (11)

1.0 (24)

 

0.12

Ancillary analysis

0.29 (11)

0.15 (2)

0.38 (9)

3.3 (0.59; 18.40)

0.15

Adverse effects

0.81 (30)

0.92 (12)

0.75 (18)

0.25 (0.03; 2.34)

0.9

Discussion

Interpretation of results

0.95 (35)

0.84 (11)

1.0 (24)

 

0.12

Generalizability

0.86 (32)

0.69 (9)

0.96 (23)

10.22 (1.00; 104.0)

0.042

Overall evidence

0.95 (35)

0.85 (11)

1.0 (24)

 

0.12

  1. CI confidence interval