From: Quality of reporting of randomized controlled trials in polycystic ovary syndrome
Data items | Combined 1990-2008 (n = 122) †| Pre-CONSORT 1990-1995 (n = 17) | Post-CONSORT 1996-2008 (n = 105) | Odds Ratio and 95% confidence intervals¥ | P-value‡ |
---|---|---|---|---|---|
TITLE/ABSTRACT | Â | Â | Â | Â | Â |
1. Randomized in title/abstract | 0.89(108) | 0.76(13) | 0.90(95) | 2.92(0.80, 10.69) | 0.11 |
INTRODUCTION | Â | Â | Â | Â | Â |
2. Scientific background in introduction | 0.89(108) | 0.94(16) | 0.88(92) | 0.44(0.05, 3.62) | 0.69 |
METHODS | Â | Â | Â | Â | Â |
3. Eligibility criteria for participants | 0.62(76) | 0.12(2) | 0.70(74) | 17.90(3.86, 83.00) | <0.01 |
4. Precise details of the interventions in each arm | 0.98(120) | 1.00(17) | 0.98(103) | 1.18(0.05, 25.70) | 0.99 |
5. Objectives | 0.97(118) | 0.82(14) | 0.99(104) | 22.29(2.17, 229.28) | 0.01 |
6. End-points | 0.63(77) | 0.18(3) | 0.70(74) | 11.14(2.99, 41.52) | <0.01 |
7. Sample size | 0.38(46) | 0.12(2) | 0.42(44) | 5.41(1.18, 24.87) | 0.03 |
8. Method of randomization (sequence generation) | 0.62(76) | 0.35(6) | 0.67(70) | 3.67(1.25, 10.74) | 0.02 |
9. Allocation concealment | 0.49(60) | 0.06(1) | 0.56(59) | 20.52(2.62, 160.49) | <0.01 |
10. Implementation of randomization | 0.23(28) | 0.00(0) | 0.27(28) | 12.87(0.75, 221.13) | 0.01 |
11. Blinding (masking) | 0.41(50) | 0.47(8) | 0.40(42) | 0.75(0.27, 2.10) | 0.61 |
12. Statistical methods | 0.95(116) | 0.88(15) | 0.96(101) | 3.37(0.57, 20.00) | 0.19 |
RESULTS | Â | Â | Â | Â | Â |
13. Participant flow | 0.60(73) | 0.35(6) | 0.64(67) | 3.23(1.11, 9.44) | 0.03 |
14. Periods: a. Recruitment | 0.51(62) | 0.06(1) | 0.58(61) | 22.18(2.84, 173.55) | <0.01 |
   b. Follow-up | 0.26(32) | 0.00(0) | 0.30(32) | 15.48(0.90, 265.24) | 0.01 |
15. Baseline data | 0.73(89) | 0.47(8) | 0.77(81) | 3.80(1.32, 10.91) | 0.02 |
16. "Intention-to-treat" analysis | 0.15(18) | 0.00(0) | 0.17(18) | 7.40(0.43, 128.64) | 0.07 |
17. a. Outcomes and | 0.99(121) | 1.00(17) | 0.99(104) | 1.99(0.08, 50.85) | 0.09 |
   b. Estimation of effects | 0.45(55) | 0.41(7) | 0.46(48) | 1.20(0.43, 3.40) | 0.79 |
18. Ancillary analyses | 0.43(52) | 0.12(2) | 0.48(50) | 6.82(1.48, 31.31) | 0.01 |
19. Adverse events | 0.49(60) | 0.24(4) | 0.53(56) | 3.71(1.14, 12.14) | 0.04 |
DISCUSSION | Â | Â | Â | Â | Â |
20. Interpretation of the results | 0.98(120) | 1.00(17) | 0.98(103) | 1.18(0.05, 25.70) | 0.99 |
21. Generalizability | 0.93(113) | 0.94(16) | 0.92(97) | 0.76(0.09, 6.47) | 0.99 |
22. Overall evidence | 0.93(113) | 0.94(16) | 0.92(97) | 0.76(0.09, 6.47) | 0.99 |