Methodological Reporting Quality of Randomized Controlled Trials in 3 Leading Diabetes Journals From 2011 to 2013 Following CONSORT Statement

Zhai, Xiao; Wang, Yiran; Mu, Qingchun; Chen, Xiao; Huang, Qin; Wang, Qijin; Li, Ming

doi:10.1097/md.0000000000001083

Cited by 22 publications

(16 citation statements)

References 29 publications

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“…The level of compliance varies depending on the CONSORT checklist item with information on participant flow through the study having the highest compliance; however, many checklist items had compliance less than 50%. Similar findings have been reported in current literature across multiple fields—diabetes journals, surgery journals, otorhinolaryngologic journals, and the Korean Journal of Anesthesiology . Our results suggest that compliance has actually decreased since the introduction of CONSORT to TRANSFUSION in checklist items such as blinding and method to generate the random allocation sequence.…”

supporting

confidence: 87%

Evaluation of CONSORT compliance in TRANSFUSION

et al. 2015

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supporting

confidence: 87%

Evaluation of CONSORT compliance in TRANSFUSION

et al. 2015

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“…[17][18][19][20][21][22][23][24][25][26][27][28][29][30] But most have focused on small numbers of trials or specific diseases, journals, or time periods. These studies used various criteria for their assessments, which were frequently not defined.…”

Section: Introductionmentioning

confidence: 99%

Evolution of poor reporting and inadequate methods over time in 20 920 randomised controlled trials included in Cochrane reviews: research on research study

Dechartres

Trinquart

Atal

et al. 2017

BMJ

132

129

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Objective To examine how poor reporting and inadequate methods for key methodological features in randomised controlled trials (RCTs) have changed over the past three decades.Design Mapping of trials included in Cochrane reviews. Data sourcesData from RCTs included in all Cochrane reviews published between March 2011 and September 2014 reporting an evaluation of the Cochrane risk of bias items: sequence generation, allocation concealment, blinding, and incomplete outcome data. Data extractionFor each RCT, we extracted consensus on risk of bias made by the review authors and identified the primary reference to extract publication year and journal. We matched journal names with Journal Citation Reports to get 2014 impact factors. Main outcomes measuresWe considered the proportions of trials rated by review authors at unclear and high risk of bias as surrogates for poor reporting and inadequate methods, respectively. ResultsWe analysed 20 920 RCTs (from 2001 reviews) published in 3136 journals. The proportion of trials with unclear risk of bias was 48.7% for sequence generation and 57.5% for allocation concealment; the proportion of those with high risk of bias was 4.0% and 7.2%, respectively. For blinding and incomplete outcome data, 30.6% and 24.7% of trials were at unclear risk and 33.1% and 17.1% were at high risk, respectively. Higher journal impact factor was associated with a lower proportion of trials at unclear or high risk of bias. The proportion of trials at unclear risk of bias decreased over time, especially for sequence generation, which fell from 69.1% in 1986-1990 to 31.2% in 2011-14 and for allocation concealment (70.1% to 44.6%). After excluding trials at unclear risk of bias, use of inadequate methods also decreased over time: from 14.8% to 4.6% for sequence generation and from 32.7% to 11.6% for allocation concealment.Conclusions Poor reporting and inadequate methods have decreased over time, especially for sequence generation and allocation concealment. But more could be done, especially in lower impact factor journals.

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“…A large systematic review updated in 2012 showed that, despite improvements in the completeness of reporting for 22 of 25 CONSORT checklist items, there are still major reporting deficiencies in some areas [5]. Subsequent reviews and research have confirmed that reporting remains suboptimal in areas such as sample size calculations and consistency between prespecified and reported outcomes [6][7][8][9]. Adherence to the CONSORT statement for Abstracts is also variable and incomplete [10].…”

Section: Introductionmentioning

confidence: 99%

Quality, scope and reporting standards of randomised controlled trials in Irish Health Research: an observational study

Clyne

Boland

Murphy

et al. 2020

Trials

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Background: Despite efforts to improve the accuracy and transparency of the design, conduct, and reporting of randomised controlled trials (RCTs), deficiencies remain. Such deficiencies contribute to significant, avoidable waste of health research investment and impede reproducibility. This study aimed to synthesise and critically analyse changes over time in the conduct and reporting of internationally published evidence on patient and/or population health-oriented RCTs conducted in one country. Methods: This observational study drew on systematic review methods. We searched six databases for published RCTs (database inception to December 2018) where ≥ 80% of participants were recruited in the Republic of Ireland. RCTs of interventions targeted at patients, providers and/or policy makers intended to improve health, healthcare or health research were included. For each study, screening, data extraction and methodological quality appraisal were conducted by one member of the author team. Results: From 17,560 titles and abstracts, 752 unique RCTs were published in 745 papers between 1968 and 2018, with a steady year-on-year increase since 1968. The number of participants was in the range of 2-8628. The majority were parallel design (86%) and classified as treatment evaluation. Of the 418 RCTs published since the introduction of mandatory clinical trial registration by the International Committee of Medical Journal Editors in 2005, 32% (n = 134) provided a trial registration number. This increased to 47% when taking studies published between 2013 and 2018 (n = 232). Since the 1996 publication of the CONSORT statement, 16% of included RCTs made specific reference to a standardised reporting guideline and this increased to 31% for more recent studies published between 2013 and 2018. Overall, 7% (n = 53) of studies referred to a published study protocol, increasing to 20% for studies published between 2013 and 2018. Conclusion: Evidence from this single-country study of RCTs published in the international literature suggests that both the number overall, the number registered and the number referencing reporting guidelines have increased steadily over time. Despite widespread endorsement of reporting standards, reporting of RCTs remains suboptimal in domains such as compliance with the CONSORT statement and prospective trial registration. Researchers, funders and journal editors, nationally and internationally, should continue to focus on improving reporting and examining avoidable waste of health research investment.

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Methodological Reporting Quality of Randomized Controlled Trials in 3 Leading Diabetes Journals From 2011 to 2013 Following CONSORT Statement

Abstract: Supplemental digital content is available in the text

Cited by 22 publications

References 29 publications

Evaluation of CONSORT compliance in TRANSFUSION

Evaluation of CONSORT compliance in TRANSFUSION

Evolution of poor reporting and inadequate methods over time in 20 920 randomised controlled trials included in Cochrane reviews: research on research study

Quality, scope and reporting standards of randomised controlled trials in Irish Health Research: an observational study

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