CONSORT at the 2009 Peer Review Congress

The 6th International Congress on Peer Review and Biomedical Publication was held on September 10th to 12th, 2009 in Vancouver. As there was a strong presence of reporting issues in the programme, members of the CONSORT Group presented some recent work in plenary and poster sessions.

On behalf of her colleagues, Sally Hopewell presented on a longitudinal study of PubMed-indexed articles aimed to assess whether quality of reporting of randomized trials has improved following publication of the revised CONSORT Statement in 2001.

They examined all primary reports of randomized trials indexed in PubMed in December 2000 (n = 519) and December 2006 (n = 616). Compared to 2001, more articles reported details of the primary outcome (RR, 1.18; 95% CI, 1.04-1.33), power calculation (RR, 1.66; 95% CI, 1.401.95), random sequence generation (RR, 1.62; 95% CI, 1.32-1.97), and allocation concealment (RR, 1.40; 95% CI, 1.11-1.76) in 2006. There was no significant difference in reporting of who was blinded (RR, 0.91; 95% CI, 0.75-1.10). In 2006, 28% of reports included a CONSORT flow diagram, and 61% gave the funding source. Also, very few reported details of trial registration (9%) or access to the trial protocol (1%). Sally noted that despite some progress in reporting of methodological details in recent years, there remains considerable room for improvement.

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Sally Hopewell also presented on a survey of the impact of CONSORT for reporting abstracts of randomized trials in high-impact journals. 

A total of 284 abstracts from 5 high-impact journals were assessed independently by 2 authors using the CONSORT for Abstracts checklist.  

Although most abstracts reported some items recommended by the CONSORT for Abstracts guidelines "“ such as participant eligibility, interventions, objectives, primary outcome "“ other items recommended by were poorly reported. Of 284 abstracts, allocation concealment was only reported in 13 (5%), sequence generation was included in only 7 (2%), specific details on who was blinded was found in only 12 (4%), trial design was described in only 65 (23%), funding source was only disclosed in 3 (1%), harms was mentioned in only 119 (42%), and number of participants randomized was explained in only 137 (48%). Interestingly, there were substantial differences in the median proportion of CONSORT items reported across journals perhaps reflecting different editorial policies. It was concluded that abstracts of randomized trials fail to meet a number of recommendations in the CONSORT for Abstracts guidelines.

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A poster about David Moher's survey of citations of the CONSORT Statement and explanatory paper was also presented.  The study set out to examine when, where, and why the CONSORT Statement is cited. Through Web of Science, 497 articles published in 2007 were identified as citing the CONSORT Statement 2001, CONSORT 2001 explanatory paper, CONSORT for Harms extension and/or CONSORT for Cluster Trials extension. 

The CONSORT papers were most commonly cited in medical or health specialty journals and most commonly cited in reports of RCTs or systematic reviews in this sample of reports. The CONSORT Statement was cited 414 times in 337 articles. It was most commonly cited once (n=291; 70%), although one paper cited it 14 times. The CONSORT explanation and elaboration paper was cited 138 times in 95 articles, and like the Statement, was most commonly cited once (n=71; 55%).  The CONSORT for harms and cluster papers were cited in 20 and 42 journals respectively, and most commonly cited once (n=28; 88% for harms; and n=50; 100% for cluster). Fify-seven articles cited more than one CONSORT paper. Most reports cite CONSORT appropriately, such as to help the reporting of a RCT, and to help generate items for data extraction from reports of RCTs. Some reports cite CONSORT inappropriately, such as a quality assessment instrument as part of the systematic review process. This cross-sectional study is part of a larger effort to fully understand the impact of CONSORT.

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