Abstract
BackgroundInadequate reporting undermines findings of randomized controlled trials (RCTs). This study assessed and compared articles published in high-impact general medical and specialized journals.MethodsReports of RCTs published in high-impact general and specialized medical journals were identified through a search of MEDLINE from January to March of 1995, 2000, 2005, and 2010. Articles that provided original data on adult patients diagnosed with chronic conditions were included in the study. Data on trial characteristics, reporting of allocation concealment, quality score, and the presence of a trial flow diagram were extracted independently by two reviewers, and discrepancies were resolved by consensus or independent adjudication. Descriptive statistics were used for quantitative variables. Comparisons between general medical and specialized journals, and trends over time were performed using Chi-square tests.ResultsReports of 284 trials were analyzed. There was a significantly higher proportion of RCTs published with adequate reporting of allocation concealment (p = 0.003), presentation of a trial flow diagram (p<0.0001) and high quality scores (p = 0.038) over time. Trials published in general medical journals had higher quality scores than those in specialized journals (p = 0.001), reported adequate allocation concealment more often (p = 0.013), and presented a trial flow diagram more often (p<0.001).InterpretationWe found significant improvements in reporting quality of RCTs published in high-impact factor journals over the last fifteen years. These improvements are likely attributed to concerted international efforts to improve reporting quality such as CONSORT. There is still much room for improvement, especially among specialized journals.
Highlights
Since its publication in 1996, the Consolidated Standards of Reporting Trials (CONSORT) statement has been endorsed by over 400 journals worldwide, is available in seven different languages, and is viewed through its website more than 100,000 times each year. [1], [2]. Despite this high level of endorsement and dissemination, studies have suggested that inadequate reporting is still highly prevalent, even among journals that have endorsed the CONSORT statement calling for the evaluation of the impact of such reporting guidelines over a long period of time. [3], [4] Research suggests that reporting quality varies according to the type of journal, with randomized controlled trials (RCTs) published in general journals having higher reported quality than those in specialized journals
Trials published in general medical journals had higher quality scores than those in specialized journals (55.5% vs. 35.2% had high quality scores, respectively, with p = 0.001), reported adequate concealment of allocation more often (50.4% vs. 35.8%, p = 0.013), and included a trial participant flow diagram more often (57.1% vs. 32.1%, p,0.001) (Table 1)
There were significant improvements in reporting of allocation concealment (32.3% in 1995, 31.9% in 2000, 42.1% in 2005, and 58.4% in 2010, p = 0.003) and presentation of a trial flow diagram (6.5% in 1995, 29.0% in 2000, 42.1% in 2005, and 84.4% in 2010, p,0.001) with the largest improvements occurring between 2005 and 2010 (Figure 2)
Summary
Since its publication in 1996, the Consolidated Standards of Reporting Trials (CONSORT) statement has been endorsed by over 400 journals worldwide, is available in seven different languages, and is viewed through its website more than 100,000 times each year. [1], [2].Despite this high level of endorsement and dissemination, studies have suggested that inadequate reporting is still highly prevalent, even among journals that have endorsed the CONSORT statement calling for the evaluation of the impact of such reporting guidelines over a long period of time. [3], [4] Research suggests that reporting quality varies according to the type of journal, with RCTs published in general journals having higher reported quality than those in specialized journals. [5] This study was designed to assess the quality of reports of RCTs evaluating interventions for chronic diseases that were published from 1995 to 2010 in high-impact journals that claim to have adopted the CONSORT statement.The study only focuses on the quality of the reports of RCTs, not the quality of the RCTs as a whole, because the latter is likely an impossible undertaking. [1], [2] Despite this high level of endorsement and dissemination, studies have suggested that inadequate reporting is still highly prevalent, even among journals that have endorsed the CONSORT statement calling for the evaluation of the impact of such reporting guidelines over a long period of time. [3], [4] Research suggests that reporting quality varies according to the type of journal, with RCTs published in general journals having higher reported quality than those in specialized journals. [5] This study was designed to assess the quality of reports of RCTs evaluating interventions for chronic diseases that were published from 1995 to 2010 in high-impact journals that claim to have adopted the CONSORT statement. This study assessed and compared articles published in high-impact general medical and specialized journals
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