| Literature DB >> 24986891 |
Sally Hopewell1, Gary S Collins2, Isabelle Boutron3, Ly-Mee Yu2, Jonathan Cook4, Milensu Shanyinde2, Rose Wharton2, Larissa Shamseer5, Douglas G Altman2.
Abstract
OBJECTIVE: To investigate the effectiveness of open peer review as a mechanism to improve the reporting of randomised trials published in biomedical journals.Entities:
Mesh:
Year: 2014 PMID: 24986891 PMCID: PMC4077234 DOI: 10.1136/bmj.g4145
Source DB: PubMed Journal: BMJ ISSN: 0959-8138

Identification of randomised trials published in BMC-series medical journals from PubMed citations indexed from January to December 2012
General characteristics of randomised trials published in BMC-series medical journals in 2012
| Characteristics | No (%) of manuscripts (n=93) |
|---|---|
| Trial design: | |
| Parallel | 75 (81) |
| Crossover | 7 (7.5) |
| Cluster | 9 (9.5) |
| Other | 2 (2) |
| Intervention: | |
| Drug | 25 (27) |
| Surgery or procedure | 13 (14) |
| Counselling or lifestyle | 35 (38) |
| Other* | 20 (21) |
| Study centres: | |
| Single | 47 (51) |
| Multiple | 30 (32) |
| Unclear | 16 (17) |
| No of study groups | |
| 2 | 75 (81) |
| 3 | 9 (9.5) |
| ≥4 | 9 (9.5) |
| Median No of participants per trial (10th to 90th centile) | 132 (30 to 527) |
*For example, education, equipment.
Details of peer review and numerical changes to manuscripts (n=93). Values are medians (ranges), interquartile ranges unless stated otherwise
| Details of peer review | Results |
|---|---|
| Factors per manuscript: | |
| Median No (range) of peer reviewers | 2 (1-5) |
| Median No (range) of peer review rounds | 2 (1-4) |
| Median No (range) of author responses | 2 (1-7) |
| Median No (range) of submitted versions | 3 (2-8) |
| Words added (range) to final submitted version (%) | 20 (2-88), 12-36 |
| Words deleted (range) from final submitted version (%) | 11 (1-60), 5-21 |
| Time between original and final submitted version (days) | 148 (29-240), 105-204 |
| Time between final submitted and published version (days) | 36 (4-142), 23-54 |
Extent of changes between original and final versions of manuscript (n=93)
| Items | No (%) | ||||
|---|---|---|---|---|---|
| Reported (no change)* | Not reported (no change)† | Added‡ | Subtracted§ | Altered¶ | |
| “Randomised” in title | 71 (76) | 15 (16) | 4 (4) | 3 (3) | 0 |
| Author names | 87 (94) | 0 | 3 (3) | 3 (3) | 0 |
| Abstract: | |||||
| Method of randomisation | 8 (9) | 84 (90) | 1 (1) | 0 | 0 |
| Primary outcome | 22 (24) | 67 (72) | 1 (1) | 0 | 3 (3) |
| No randomised | 28 (30) | 64 (69) | 1 (1) | 0 | 0 |
| No analysed | 14 (15) | 79 (85) | 0 | 0 | 0 |
| Conclusion | 78 (84) | 0 | 0 | 0 | 15 (16) |
| Methods: | |||||
| Sequence generation | 44 (47) | 35 (38) | 11 (12) | 0 | 3 (3) |
| Allocation sequence | 32 (34) | 50 (54) | 9 (10) | 0 | 2 (2) |
| Blinding | 31 (33) | 46 (50) | 11 (12) | 0 | 5 (5) |
| Primary outcome | 47 (51) | 33 (35) | 0 | 0 | 13 (14) |
| Secondary outcomes | 47 (51) | 33 (35) | 2 (2) | 0 | 11 (12) |
| Sample size | 42 (45) | 32 (34) | 9 (10) | 2 (2) | 8 (9) |
| Results: | |||||
| Flow diagram | 52 (56.5) | 25 (27) | 9 (10) | 0 | 6 (6.5) |
| No randomised | 77 (83) | 8 (9) | 6 (6) | 0 | 2 (2) |
| No analysed | 73 (78) | 14 (15) | 5 (5) | 0 | 1 (1) |
| Primary outcome | 33 (35) | 51 (55) | 0 | 0 | 9 (10) |
| Secondary outcomes | 31 (33) | 51 (55) | 3 (3) | 0 | 8 (9) |
| Additional analyses | 9 (10) | 65 (70) | 19 (20) | 0 | |
| Tables (important changes) | 56 (60) | 3 (3) | 17 (18) | 3 (3) | 14 (15) |
| Figures (important changes) | 56 (60) | 15 (16) | 14 (15) | 4 (4) | 4 (4) |
| Harms | 28 (30) | 60 (65) | 2 (2) | 0 | 3 (3) |
| Conclusions | 63 (68) | 0 | 0 | 0 | 30 (32) |
| Other information: | |||||
| Funding | 67 (72) | 15 (16) | 5 (5) | 0 | 4 (4) |
| Trial protocol | 8 (9) | 84 (90) | 1 (1) | 0 | 0 |
| Trial registration | 47 (51) | 21 (23) | 22 (24) | 1 (1) | 2 (2) |
*Item reported in both original and final submitted version of manuscript (no change on wording).
†Item not reported in either original or final submitted version of manuscript.
‡Item new to final submitted version, was not in original version of manuscript.
§Item removed from final submitted version, was in original version of manuscript.
¶Item in both original and final submitted version of manuscript but wording changed (usually involved giving more detail for a specific item).
Nature of changes requested by peer reviewers (per manuscript) and impact on reporting
| Nature of changes | No (%) | ||||
|---|---|---|---|---|---|
| Manuscripts (n=93) | Positive impact* | No impact on reporting† | No impact on reporting§ | Negative impact¶ | |
| Abstract conclusion | 15 (16) | 14 (93) | 0 | 0 | 1 (7) |
| Trial design (randomisation and blinding) | 29 (31) | 27 (93) | 2 (7) | 0 | 0 |
| Sample size | 30 (32) | 15 (50) | 11 (37) | 0 | 4 (13) |
| Primary and secondary outcomes: methods | 22 (24) | 16 (73) | 3 (13) | 1 (5) | 2 (9) |
| Primary and secondary outcomes: results | 15 (16) | 14 (93) | 0 | 0 | 1 (7) |
| Additional analyses | 20 (22) | 4 (20) | 0 | 1 (5) | 15 (75) |
| Conclusion | 30 (32) | 27 (90) | 0 | 0 | 3 (10) |
*Peer reviewers’ comments judged to have beneficial effect on reporting, and author made change.
†Peer reviewers’ comments judged to have beneficial effect on reporting, and author did not make change.
§Peer reviewers’ comments judged to have harmful effect on reporting, and author did not make change.
¶Peer reviewers’ comments judged to have harmful effect on reporting, and author made change.
Description of peer reviewer (PR) comments (per manuscript), author responses (AU), and impact of reporting
| Item | Positive impact* | No impact† | No impact‡ | Negative impact§ |
|---|---|---|---|---|
| Abstract conclusion | PR: conclusions do not reflect results. AU: toned down conclusion (n=14) | PR: revise conclusions. AU: inflated conclusion not reflecting results (n=1) | ||
| Trial design | PR: no details on randomisation/blinding. AU: added item (n=19). PR: clarify details on randomisation/blinding. AU: gave more detail (n=8) | PR: explain randomisation. AU: added text but did not understand concept (n=2) | ||
| Sample size | PR: no sample size. AU: added item (n=7). PR: justify sample size. AU: gave more detail (n=8) | PR: no sample size. AU: did not response or said did not do one (n=6). PR: small sample size. AU: justified sample size in response but not in manuscript (n=4). PR: small sample size. AU: added to limitations section (n=1) | PR: justify how sample done. AU: deleted sample size (n=2). PR: justify sample size. AU: added post hoc sample size, but was not reported as such in manuscript (n=2) | |
| Primary and secondary outcomes measured | PR: clarify which primary and secondary outcomes. AU: gave more detail (n=5). PR: how measured. AU: gave more detail (n=11) | PR: clarify how primary outcome measured. AU: did not respond (n=3) | PR: change primary outcome. AU: said no as not primary outcome for the study (n=1) | PR: add new secondary outcome. AU: added new outcome in methods (n=2) |
| Primary and secondary outcomes results | PR: clarify results. AU: gave more detail (n=12). PR: no results. AU: added results for secondary outcome (n=2) | PR: add new secondary outcome. AU: added new outcome in results (n=1) | ||
| Additional analyses | PR: clarify analysis. AU: added results for comparison across groups (n=4) | PR: add new additional analyses. AU: said no was not purpose of the study (n=1) | PR: add new additional analyses. AU: added subgroup/sensitivity analysis (n=15) | |
| Conclusion | PR: conclusions do not reflect results. AU: toned down conclusion (n=27) | PR: revise conclusions. AU: inflated conclusion but did not reflect results (n=3) |
*Peer reviewers’ comments judged to have beneficial effect on reporting, and author made change.
†Peer reviewers’ comments judged to have beneficial effect on reporting, and author did not make change.
‡Peer reviewers’ comments judged to have harmful effect on reporting, and author did not make change.
§Peer reviewers’ comments judged to have harmful effect on reporting, and author made change.