Original Article
The quality of reporting of trial abstracts is suboptimal: Survey of major general medical journals

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Abstract

Objective

To evaluate the quality of reporting of abstracts describing randomized controlled trials (RCTs) published in four major general medical journals.

Study Design and Setting

Systematic survey of published RCT abstracts, with two reviewers independently extracting data. We searched MEDLINE and identified 227 RCT abstracts published in the New England Journal of Medicine (NEJM), Journal of the American Medical Association (JAMA), British Medical Journal (BMJ), and The Lancet in the year 2006.

Results

Most abstracts identified the study as a randomized trial (98.7%), reported the objectives (92.5%), described the population (90.3%), detailed the intervention (81.5%), and defined the primary outcome (71.3%). Methodological quality was poorly reported: one (0.4%) described allocation concealment; 21 (9.3%) clearly specified blinding; 51 (22.5%) described intention-to-treat analysis; and 32 (14.1%) outlined losses to follow-up. Most of the abstracts reported the effect size and the confidence intervals (62.3%), but just half of them reported side effects or harms.

Conclusion

The quality of reporting of RCT abstracts published in main general medical journals is suboptimal. Space limitations notwithstanding, with the recent recommendations from the CONSORT for Abstracts, it is expected that the transparency of abstract reporting can and should improve.

Section snippets

1 Introduction

Randomized controlled trials (RCTs) represent the reference standard to estimate the benefits and harms of preventive and therapeutic interventions [1]. Health care professionals, systematic reviewers, and guideline developers need to critically appraise RCTs to determine their methodological quality (using criteria, such as allocation concealment, blinding, intention-to-treat analysis) and the importance of the results (estimates of benefit and harm, and their precision) [2], [3], [4], [5].

2.1 Design

We conducted a systematic survey of RCT abstracts published in four major medical journals: The New England Journal of Medicine (NEJM), The Lancet, Journal of the American Medical Association (JAMA), and British Medical Journal (BMJ) in the year 2006.

2.2 Eligibility

We included abstracts of RCTs of preventive or therapeutic interventions. We excluded abstracts of other study designs, including observational studies, quasi-randomized trials, economic analyses based on RCTs, editorials, and letters. We also

3 Results

Our search strategy yielded 256 abstracts, from which 29 were excluded (11 observational studies based on RCT data, eight cluster RCTs, three economic analysis, three RCTs of diagnostic tests, three letters, and one quasi-randomized study), as presented in Fig. 1. From the 227 included abstracts, 98.6% presented the results of superiority trials and 1.3% were crossover studies.

4 Discussion

In this systematic survey, we found that all abstracts published in four prominent general medical journals in 2006 were structured (as expected, because it is a formal requirement for all four journals), and almost all identified the study as an RCT, specified the study population, objectives, and trial interventions. On the other hand, methodological quality reporting was insufficient; only one abstract reported on allocation concealment, and a small proportion accurately reported on blinding

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