The quality of reporting of trial abstracts is suboptimal: Survey of major general medical journals (original) (raw)
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Background The extended Consolidated Standards of Reporting Trials (CONSORT) Statement for Abstracts was developed to improve the quality of reports of randomized controlled trials (RCTs) because readers often base their assessment of a trial solely on the abstract. To date, few data exist regarding whether it has achieved this goal. We evaluated the extent of adherence to the CONSORT for Abstract statement for quality of reports on RCT abstracts by four high-impact general medical journals. Methods A descriptive analysis of published RCT abstracts in The New England Journal of Medicine (NEJM), The Lancet, The Journal of American Medical Association (JAMA), and the British Medical Journal (BMJ) in the year 2010 was conducted by two reviewers, independently extracting data from a MEDLINE/PubMed search. Results We identified 271 potential RCT abstracts meeting our inclusion criteria. More than half of the abstracts identified the study as randomized in the title (58.7%; 159/271), reported the specific objective/hypothesis (72.7%; 197/271), described participant eligibility criteria with settings for data collection (60.9%; 165/271), detailed the interventions for both groups (90.8%; 246/271), and clearly defined the primary outcome (94.8%; 257/271). However, the methodological quality domains were inadequately reported: allocation concealment (11.8%; 32/271) and details of blinding (21.0%; 57/271). Reporting the primary outcome results for each group was done in 84.1% (228/271). Almost all of the abstracts reported trial registration (99.3%; 269/271), whereas reports of funding and of harm or side effects from the interventions were found in only 47.6% (129/271) and 42.8% (116/271) of the abstracts, respectively. Conclusions These findings show inconsistencies and non-adherence to the CONSORT for abstract guidelines, especially in the methodological quality domains. Improvements in the quality of RCT reports can be expected by adhering to existing standards and guidelines as expressed by the CONSORT group.
Neurourology and Urodynamics, 2005
The quality of randomised controlled trials (RCTs) is associated with bias. Thus, reports of RCTs must have enough detail of key elements of quality to enable them to be interpreted properly. This study examines the quality of abstracts of RCTs reported at the ICS meeting in Heidelberg in 2002, using the CONSORT statement as the gold standard. Materials and Methods: All of the abstracts accepted for the meeting at Heidelberg were read to identify reports of RCTs. Copies of these were printed and examined to see whether they complied with the 22 items in the CONSORT statement. As these were all abstracts the ¢rst CONSORT item was changed so that to comply the title had to say it was a randomised trial. Each item was scored as not met, partially met, met. Results: Fifty-three reports of RCTs were found. Five of these were podium presentations, 14 discussion posters, and 34 non-discussion posters. Most reports did not comply with many of the items in the CONSORT statement, lacking particularly in technical details of the methods (only one study clearly reported hidden allocation to groups), and how the results were presented (only two studies fully reported results). Only 2/53 of the abstracts complied fully with more than 10 of the items, and 30/53 did not comply at all with 10 or more. Conclusions: The quality of reporting of studies at ICS is so poor that it is di⁄cult to interpret the results. Reporting was particularly poor on the details of the randomisation and the numeric results.
Reporting quality of trial abstracts-improved yet suboptimal: A systematic review and meta-analysis
Journal of Evidence-Based Medicine, 2018
Objectives: We conducted a systematic review and meta-analysis of literature to determine if the publication of the Consolidated Standards of Reporting Trials (CONSORT) abstract guideline in 2008 was followed by change in reporting quality of randomized controlled trial (RCT) abstracts. Study design and settings: Evaluations were included if they compared reporting quality of RCT abstracts before and after the publication of CONSORT-abstract guideline. The literature search was performed (January 2008 to April 2017) in Medline (Ovid), EMbase, CINAHL plus and Cochrane methodologies register. We assessed study validity with a special validity tool, adapted from a previous Cochrane review. Results: Initial search identified 4142 articles, of which total 10 evaluations including 5184 abstracts were included. Total 22 outcomes related to individual items of CONSORT-abstract guideline were assessed, and 14 showed significant effect sizes favoring CONSORT-abstract guideline. Despite significant effect size, the overall post-CONSORT reporting (PCR) was suboptimal for ten items: title (
Evidence-based abstracts: what research summaries should contain to support evidence-based medicine
International Journal of Evidence-Based Healthcare, 2012
The practice of evidence-based medicine involves the integration of individual clinical expertise with the best available external clinical evidence from the systematic retrieval of the most current literature. Clinicians need to conduct a critical appraisal of the medical articles they access. However, clinicians in developing countries usually lack access to the best resources for evidence-based practice (EBP). The abstracts of 100 of the most recently published randomised controlled trials were used in the present study. These abstracts were critically appraised using a new questionnaire. Questions 1 to 8 were answerable by 38%, 26%, 52%, 23%, 12%, 53%, 36% and 12%, respectively, of the examined summaries. EBP requires better access to medical resources. Therefore, the summaries of relevant studies should be complete and self-sufficient to support EBP. This means a research summary should adequately report the findings of a clinical trial without needing to access the full text.
The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration
Annals of Internal Medicine, 2001
Overwhelming evidence now indicates that the quality of reporting of randomized, controlled trials (RCTs) is less than optimal. Recent methodologic analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which boast the elimination of systematic error as their primary hallmark. Systematic error in RCTs reflects poor science, and poor science threatens proper ethical standards.
PLoS ONE, 2013
Background: Inadequate reporting undermines findings of randomized controlled trials (RCTs). This study assessed and compared articles published in high-impact general medical and specialized journals. Methods: Reports 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 Chisquare tests. Results: Reports 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). Interpretation: We 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.
Journal of the Royal Society of Medicine, 2007
Objective Scientific and ethical justification for new clinical trials requires them to have been designed in the light of scientifically defensible assessments of relevant previous research. Reliable interpretation of the results of new clinical trials entails setting them in the context of updates of the reviews upon which they were deemed scientifically and ethically justifiable. We have shown previously that most reports of randomized trials published in five general medical journals in May 1997 and in May 2001 failed to set their results in the context of the findings from similar research. In the current study, we assess whether there had been progress in this respect in 2005 and also investigate the extent to which reports begin by referring to systematic reviews providing the justification for the new research reported. Design Assessment of the Introduction and Discussion sections in all reports of randomized trials published during May 2005 in five general medical journals. Setting Reports of randomized trials in five general medical journals.
Controlled Clinical Trials, 2002
The "Consolidated Standards of Reporting Trials" (CONSORT) was developed to improve the suboptimal reporting of randomized controlled trials (RCTs). However, little is known about the quality of reporting since this publication. We undertook an observational study to determine the quality of reporting key methodological factors in RCTs since the publication of the CONSORT statement and if a journal policy to promote adherence to the CONSORT checklist was associated with superior reporting. We recorded the reporting of 11 key methodological factors in 105 RCTs from 29 medical journals published subsequent to the CONSORT statement. We examined the quality of reporting in relation to whether a journal was a "CONSORT promoter" as defined by inclusion of the CONSORT checklist in a journal's "information to authors" section or a requirement that authors, manuscript reviewers, or copy editors complete the CONSORT checklist. Multivariate analysis controlled for journal impact factor, study outcome, and time of publication. Six of the 11 methodological factors were reported Ͻ 50% of the time. The number of methodological factors reported was greater in CONSORT promoters than in journals not promoting CONSORT in both unadjusted (6.0 and 5.1, respectively,
Annals of internal medicine
Overwhelming evidence now indicates that the quality of reporting of randomized, controlled trials (RCTs) is less than optimal. Recent methodologic analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which boast the elimination of systematic error as their primary hallmark. Systematic error in RCTs reflects poor science, and poor science threatens proper ethical standards.