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 | Â | Â | Â | Â | Â |
1. Randomized in title/abstract | 0.84 (222) | 0.78 (21) | 0.85 (201) | 1.60(0.60, 4.23) | 0.4 |
INTRODUCTION | Â | Â | Â | Â | Â |
2. Scientific background in introduction | 0.89 (234) | 0.89 (24) | 0.89 (210) | 0.97(0.27, 3.45) | 0.99 |
METHODS | Â | Â | Â | Â | Â |
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 | Â | Â | Â | Â | Â |
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 | Â | Â | Â | Â | Â |
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 |