From: Quality of reporting of randomized controlled trials in polycystic ovary syndrome
Data items | Combined 1990-2008 (n = 142) †| Pre-CONSORT 1990-1995 (n = 10) | Post-CONSORT 1996-2008 (n = 132) | Odds Ratio and 95% confidence intervals¥ | P-value‡ |
---|---|---|---|---|---|
TITLE/ABSTRACT | Â | Â | Â | Â | Â |
1. Randomized in title/abstract | 0.80(114) | 0.80(8) | 0.80(106) | 1.02(0.20, 5.09) | 0.99 |
INTRODUCTION | Â | Â | Â | Â | Â |
2. Scientific background in introduction | 0.89(126) | 0.80(8) | 0.89(118) | 2.11(0.41, 10.92) | 0.31 |
METHODS | Â | Â | Â | Â | Â |
3. Eligibility criteria for participants | 0.70(100) | 0.30(3) | 0.73(97) | 6.47(1.58, 26.40) | 0.01 |
4. Precise details of the interventions in each arm | 0.99(141) | 1.00(10) | 0.99(131) | 4.17(0.16, 108.94) | 0.99 |
5. Objectives | 0.96(136) | 0.90(9) | 0.96(127) | 2.82(0.30, 26.80) | 0.36 |
6. End-points | 0.66(94) | 0.30(3) | 0.69(91) | 5.18(1.27, 21.04) | 0.03 |
7. Sample size | 0.24(34) | 0.20(2) | 0.24(32) | 1.28(0.26, 6.34) | 0.99 |
8. Method of randomization (sequence generation) | 0.51(72) | 0.20(2) | 0.53(70) | 4.52(0.92, 22.07) | 0.05 |
9. Allocation concealment | 0.31(44) | 0.10(1) | 0.33(43) | 4.35(0.53, 35.43) | 0.17 |
10. Implementation of randomization | 0.20(28) | 0.00(0) | 0.21(28) | 5.73(0.33, 100.73) | 0.21 |
11. Blinding (masking) | 0.49(70) | 0.20(2) | 0.52(68) | 4.25(0.87, 20.77) | 0.09 |
12. Statistical methods | 0.96(136) | 0.90(9) | 0.96(127) | 2.82(0.30, 26.80) | 0.36 |
RESULTS | Â | Â | Â | Â | Â |
13. Participant flow | 0.65(92) | 0.00(0) | 0.70(92) | 47.96(2.74, 838.36) | <0.01 |
14. Periods: a. Recruitment | 0.25(36) | 0.00(0) | 0.27(36) | 7.94(0.45, 139.05) | 0.07 |
   b. Follow-up | 0.37(53) | 0.10(1) | 0.39(52) | 5.85(0.72, 47.55) | 0.09 |
15. Baseline data | 0.87(123) | 0.60(6) | 0.89(117) | 5.20(1.32, 20.56) | 0.03 |
16. "Intention-to-treat" analysis | 0.11(15) | 0.00(0) | 0.11(15) | 2.77(0.15, 49.65) | 0.61 |
17. a. Outcomes and | 0.99(141) | 1.00(10) | 0.99(131) | 4.17(0.16, 108.94) | 0.99 |
   b. Estimation of effects | 0.62(88) | 0.50(5) | 0.63(83) | 1.69(0.47, 6.15) | 0.51 |
18. Ancillary analyses | 0.36(51) | 0.20(2) | 0.37(49) | 2.36(0.48, 11.57) | 0.33 |
19. Adverse events | 0.51(72) | 0.50(5) | 0.51(67) | 1.03(0.28, 3.37) | 0.99 |
DISCUSSION | Â | Â | Â | Â | Â |
20. Interpretation of the results | 0.99(140) | 1.00(10) | 0.98(130) | 2.49(0.11, 55.22) | 0.99 |
21. Generalizability | 0.92(130) | 0.80(8) | 0.92(122) | 3.05(0.57, 16.34) | 0.21 |
22. Overall evidence | 0.87(124) | 0.60(6) | 0.89(118) | 5.62(1.41, 22.36) | 0.02 |