Skip to main content

Table 1 Proportion of reporting of 24 data items in a total of 264 randomized clinical trials in polycystic ovary syndrome by publication period (pre- and post-CONSORT and combined)*

From: Quality of reporting of randomized controlled trials in polycystic ovary syndrome

Data items

Combined

1990-2008

(n = 264)†

Pre-CONSORT

1990-1995

(n = 27)

Post-CONSORT

1996-2008

(n = 237)

Odds Ratio and 95% confidence intervals¥

P-value‡

TITLE/ABSTRACT

     

1. Randomized in title/abstract

0.84 (222)

0.78 (21)

0.85 (201)

1.60(0.60, 4.23)

0.4

INTRODUCTION

     

2. Scientific background in introduction

0.89 (234)

0.89 (24)

0.89 (210)

0.97(0.27, 3.45)

0.99

METHODS

     

3. Eligibility criteria for participants

0.67(176)

0.19 (5)

0.72 (171)

11.40(4.14, 31.35)

<0.01

4. Precise details of the interventions in each arm

0.99 (261)

1.00 (27)

0.99 (234)

1.22(0.06, 24.21)

0.99

5. Objectives

0.96 (254)

0.85 (23)

0.97 (231)

6.70(1.76, 25.46)

0.01

6. End-points

0.65 (171)

0.22 (6)

0.7 (165)

8.02(3.11, 20.71)

<0.01

7. Sample size

0.30 (80)

0.15 (4)

0.32 (76)

2.71(0.91, 8.12)

0.08

8. Method of randomization (sequence generation)

0.56 (148)

0.30 (8)

0.59 (140)

3.43(1.44, 8.15)

<0.01

9. Allocation concealment

0.39 (104)

0.07 (2)

0.43 (102)

9.44(2.19, 40.49)

<0.01

10. Implementation of randomization

0.21 (56)

0.00 (0)

0.24 (56)

17.12(1.03, 285.19)

<0.01

11. Blinding (masking)

0.45 (120)

0.37 (10)

0.46 (110)

1.47(0.65, 3.35)

0.42

12. Statistical methods

0.95 (252)

0.89 (24)

0.96 (228)

3.17(0.80, 12.50)

0.11

RESULTS

     

13. Participant flow

0.625 (165)

0.22 (6)

0.67 (159)

7.13(2.77, 18.39)

<0.01

14. Periods: a. Recruitment

0.37 (98)

0.04 (1)

0.41 (97)

18.01(2.40, 134.99)

<0.01

   b. Follow-up

0.32 (85)

0.04 (1)

0.35 (84)

14.27(1.90, 107.07)

<0.01

15. Baseline data

0.80 (212)

0.52 (14)

0.84 (198)

4.71(2.06, 10.80)

<0.01

16. "Intention-to-treat" analysis

0.125 (33)

0.00 (0)

0.14 (33)

9.01(0.54, 151.26)

0.03

17. a. Outcomes and

0.99 (262)

1.00 (27)

0.99 (235)

1.71(0.08, 36.60)

0.99

   b. Estimation of effects

0.54 (143)

0.44 (12)

0.55 (131)

1.54(0.69, 3.44)

0.31

18. Ancillary analyses

0.39 (103)

0.15 (4)

0.42 (99)

4.13(1.38, 12.30)

0.01

19. Adverse events

0.50 (132)

0.33 (9)

0.52 (123)

2.16(0.93, 5.00)

0.1

DISCUSSION

     

20. Interpretation of the results

0.98 (260)

1.00 (27)

0.98 (233)

0.94(0.05, 18.00)

0.99

21. Generalizability

0.92 (243)

0.89 (24)

0.92 (219)

1.52(0.42, 5.54)

0.46

22. Overall evidence

0.90 (237)

0.81 (22)

0.91 (215)

2.22(0.77, 6.45)

0.17

  1. * CONSORT = Consolidated Standards of Reporting Trials.
  2. † The percentage of articles reporting the CONSORT item.
  3. ¥ Odds ratio of reporting an item at post-CONSORT period relative to pre-CONSORT.
  4. ‡ P-values from Fisher's exact test for testing the association between reporting an item and publication period.