Characteristics of randomised controlled trials included in the study
| Characteristic | Accepted by The BMJ n (%) | Rejected by The BMJ n (%) | ||
|---|---|---|---|---|
| Trial design | ||||
| Parallel | 16 | (76) | 17 | (81) |
| Cluster | 4 | (19) | 3 | (14) |
| Cross-over | 0 | (0) | 1 | (5) |
| Factorial | 1 | (5) | 0 | (0) |
| Multicentre/single centre | ||||
| Multicentre | 18 | (86) | 15 | (71) |
| Single centre | 3 | (14) | 6 | (29) |
| Trial sample size | ||||
| <100 | 1 | (5) | 4 | (19) |
| 100–999 | 14 | (67) | 13 | (62) |
| >1000 | 6 | (29) | 4 | (19) |
| Duration of trial (follow-up) | ||||
| <12 months | 8 | (38) | 10 | (48) |
| 12 to 24 months | 12 | (57) | 9 | (43) |
| >24 months | 1 | (5) | 1 | (5) |
| Unclear | 0 | (0) | 1 | (5) |
| Location of lead investigator | ||||
| UK | 10 | (48) | 6 | (29) |
| Rest of Europe | 6 | (29) | 5 | (24) |
| North America | 0 | (0) | 1 | (5) |
| Rest of World | 5 | (24) | 9 | (43) |
| Source of funding | ||||
| Commercial | 0 | (0) | 0 | (0) |
| Non-commercial | 15 | (71) | 18 | (86) |
| Both | 5 | (24) | 3 | (14) |
| Not stated | 1 | (5) | 0 | (0) |
| Trial registration | ||||
| Yes | 21 | (100) | 21 | (100) |
| No | 0 | (0) | 0 | (0) |
| Where was the trial registered | ||||
| Clinical trials.gov | 2 | (10) | 6 | (29) |
| ISRCTN Register | 16 | (76) | 9 | (43) |
| Australian/New Zealand CTR | 1 | (5) | 5 | (24) |
| Dutch Trial Register | 2 | (10) | 0 | (0) |
| UMIN CTR | 0 | (0) | 1 | (5) |
| Prospective/retrospective registered | ||||
| Prospective | 19 | (91) | 10 | (48) |
| Retrospective | 1* | (5) | 10 | (48) |
| Unclear† | 1 | (5) | 1 | (5) |
| Published protocol | ||||
| Yes | 14 | (67) | 11 | (52) |
| No | 7 | (33) | 10 | (48) |
| Where was the protocol published: (n=14 accepted, n=11 rejected) | ||||
| BMC series | 13 | (93) | 10 | (91) |
| Other | 1‡ | (7) | 1§ | (9) |
*Study started March 1999, prior to ICMJE trial registration recommendation.
†Exact date first participant recruited into trial not provided.
‡Published in Contemporary Clinical Trials.
§Published in Journal of Foot and Ankle Research.
BMC, BioMed Central; CTR, Clinical Trial Registry; ICMJE, International Committee of Medical Journal Editors; ISRCTN, International Standard Randomised Controlled Trials Number; UMIN, University Hospital Medical Information Network.