Trends in the quality of abstracts of articles describing randomized controlled cancer trials (RCTs) from 1975–2004

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6541-6541
Author(s):  
D. W. Cescon ◽  
C. M. Booth ◽  
L. Wang ◽  
I. F. Tannock ◽  
M. K. Krzyzanowska

6541 Background: Busy oncologists may rely on abstracts to obtain most of their information from published reports. Here we evaluate the quality of abstracts in articles reporting RCTs, and whether quality of reporting has changed over time. Methods: Reports of RCTs evaluating systemic therapy for breast, colorectal and non-small cell lung cancer published 1975–2004 in 6 major journals were identified. The quality of abstracts was evaluated using a scale which awards 1 point for full and 1/2 point for partial reporting of each of 6 items: study rationale, statement of primary endpoint, description of intervention, treatment effect size, P-values or confidence intervals (CI), and toxicity. The scale was a modification of one previously developed to assess quality of reporting of conference abstracts. Trends in the reporting of individual items and composite scores were evaluated over three 10-year periods (1975–84, 1985–94, 1995–2004) using descriptive statistics. Results: Of 326 eligible articles, 319 had an abstract. Unstructured abstracts were common before 1994 ( Table ). The minimum and maximum quality scores assigned were 0.5 and 6/6. Median quality scores improved significantly with time (from 2.5 to 4.5/6, P < .001), as did inclusion of each of the individual items (P < .001). In the most recent 10-year period, three variables were adequately reported in less than half of abstracts (primary endpoint 38.0%, rationale 38.6%, toxicity 40.4%). Since the publication of the revised CONSORT statement in 2001, reporting of these items has improved (58.2%, 47.8%, 44.8% for 2002–2004). Conclusions: Quality of abstracts for published RCTs has improved over time, but deficiencies still exist. Items requiring improved reporting include identification of the primary endpoint, description of rationale, and a summary of toxicity. No significant financial relationships to disclose. [Table: see text]

2012 ◽  
Vol 30 (2) ◽  
pp. 210-216 ◽  
Author(s):  
Benoit You ◽  
Hui K. Gan ◽  
Gregory Pond ◽  
Eric X. Chen

Purpose To improve the quality of reporting of randomized clinical trials (RCTs), international registries for RCTs and guidelines for primary end point (PEP) analysis were established. The objectives of this systematic review were to evaluate concordance of PEP between publication and the corresponding registry and to assess intrapublication consistency in PEP reporting. Methods All adult oncology RCTs in solid tumors published in 10 journals between 2005 and 2009 were reviewed. Registration information was extracted from international trial registries. Results A total 366 RCTs were identified. Trial registration was found for 215 trials, and the rate increased from 43% in 2005 to 82% in 2009 (P < .001). There were 134 RCTs with clearly defined PEPs in registry, with the rate increasing from 15% to 67% (P < .001). PEP differed between registration and final publication in 14% trials with clearly defined PEPs. Reporting issues in methodology were found in 15% of RCTs, mainly because of inadequate reporting of PEP or sample size calculation. Problems with the interpretation of trial results were found in 22% publications, mostly resulting from negative superiority studies being interpreted as showing equivalence. Conclusion The rates of trial registration and of trials with clearly defined PEPs have improved over time; however, 14% of these trials reported a different PEP in the final publication. Intrapublication inconsistencies in PEP reporting are frequent. Our findings highlight the need for investigators, peer reviewers, and readers to exercise increased awareness and scrutiny of reporting outcomes of oncology RCTs.


2018 ◽  
Vol 5 (1) ◽  
pp. 21
Author(s):  
Mahmood E. Elrggal ◽  
Morooj Al-Muwallad ◽  
Areej Al-Otaibi ◽  
Jomanah Alsiddik ◽  
Alaa Shahbar ◽  
...  

<p class="abstract"><strong>Background:</strong> Randomized controlled trials are often considered as the gold standard for measuring the effectiveness of an intervention. However, inappropriate or poor reporting in randomized controlled trials can produce biased estimates of treatment effects.<strong> </strong>Clinical trials that do not use the CONSORT statement for reporting their findings will have limited value to the clinicians and researchers due to the risk of bias in their results. This review aims to assess the quality of reporting of randomized controlled trials in <em>Helicobacter pylori</em> associated infections by using the CONSORT 2010 checklist.</p><p class="abstract"><strong>Methods:</strong> All issues of 20 highly ranked gastroenterology journals published from Jan 2011 up to November 2017 were searched. Searches were conducted in November 2017. Randomized controlled trials reporting on <em>Helicobacter pylori</em> associated infections were included in the review.</p><p class="abstract"><strong>Results:</strong> 21 randomized controlled trials published in gastroenterology journals were included in the study. All included studies adequately reported (100%) on items including description of interventions, outcomes assessed, total number of participants analysed, baseline characteristics and results of outcome assessed. However, items including blinding and mechanism of allocation concealment were reported in only 12 randomized controlled trials (50%).<strong> </strong>The maximum and minimum scores and percentage of compliance of included randomised controlled trials were 24 (100%) and 15 (62.5%) respectively.</p><p><strong>Conclusions: </strong>The finding of this review suggests that the overall quality of reporting in the included randomized controlled trials was adequate. However, items including trial design, trial registration and protocol and sample size calculations should be reported adequately in the future randomized controlled trials to improve the quality of reporting and replicability of clinical trials.</p>


Vaccines ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 770
Author(s):  
Veranyuy D. Ngah ◽  
Akhona V. Mazingisa ◽  
Moleen Zunza ◽  
Charles S. Wiysonge

The statement on Consolidated Standards of Reporting Trials (CONSORT) ensures transparency in the reporting of randomized trials. However, it is unclear if the statement has led to improvement in the quality of reporting of tuberculosis (TB) vaccine trials. We explored the quality of reporting of TB vaccine trials according to the latest version of the CONSORT statement, released in 2010. We searched PubMed and the Cochrane Central Register of Controlled Trials in August 2019. We conducted screening, study selection, and data extraction in duplicate; and resolved differences through discussion. We assessed reporting to be adequate if trials reported at least 75% of the CONSORT 2010 items. We conducted a trend analysis to assess if there was improvement in reporting over time. We also used logistic regression to assess factors associated with adequate reporting. We included 124 trials in the analyses. The mean proportion of adherence was 67.3% (95% confidence interval 64.4% to 70.1%), with only 46 (37%) trials having adequate reporting. There was a significant improvement in the quality of reporting over time (p < 0.0001). Trials published in journals with impact factors between 10 and 20 were more likely to have adequate reporting (odds ratio 9.4; 95% confidence interval 1.30 to 67.8), compared to lower-impact-factor journals. Despite advances over time, the reporting of TB vaccine trials is still inadequate and requires improvement.


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