A retrospective survey of quality of reporting on randomized controlled trials of metformin for polycystic ovary syndrome

Chen, Baoying; Liu, Jian; Zhang, Chun; Li, Minyan

doi:10.1186/1745-6215-15-128

Cited by 11 publications

(15 citation statements)

References 31 publications

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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

127

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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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

127

129

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“…These key methodological items are critical to avoid bias in selection, performance/detection, and attribution. Ultimately, clinical trials with inadequate methodological design can overestimate therapeutic effects [ 47 ]. In order to resolve these problems, more researchers involved in clinical trials must be trained in study design and RCT reporting.…”

Section: Discussionmentioning

confidence: 99%

Assessing the quality of reports about randomized controlled trials of scalp acupuncture combined with another treatment for stroke

You

Cho²,

Kim

et al. 2017

BMC Complement Altern Med

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BackgroundThis study was designed to assess the quality of reporting on randomized controlled trials (RCTs) of scalp acupuncture for the treatment of stroke.MethodsThe following 8 databases were systematically investigated from their inception to December 2015: PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, National Institute of Informatics Scholarly and Academic Information Navigator, National Digital Science Library, Korean Traditional Knowledge Portal, and Korean Studies Information Service System. RCTs utilizing scalp acupuncture as an intervention for stroke were selected, and the quality of reports was assessed based on the Consolidated Standards of Reporting Trials 2010 statement (CONSORT) and Standards for Reporting Interventions in Controlled Trials of Acupuncture 2010 (STRICTA). For each study, the overall quality score (OQS) of 13 CONSORT items, a combined key methodological index score (MIS) of 5 CONSORT items, and the OQS of 17 STRICTA items were measured.ResultsThe original reports of 63 RCTs were ultimately obtained, and the median CONSORT OQS was 7 (minimum 2, maximum 11). Particularly, the items ‘trial design’, ‘sample size’, ‘ancillary analyses’, and ‘harms’ had a positive rate of less than 10%. The median MIS was 1 (minimum 0, maximum 5), with ‘allocation concealment and implementation’ and ‘intent-to-treat analysis (ITT) analysis’ having a positive rate of less than 10%. The median STRICTA OQS was 11 (minimum 6, maximum 14), and only the items ‘sample size’ and ‘intent-to-treat analysis’ were reported, with a positive rate of less than 10%. The mean CONSORT OQS increased by approximately 0.81 for each 5-year period in which manuscripts were published (95% confidence interval: 0.43 to 1.19; p < 0.001). No variable was significantly associated with MIS in the ordinal regression model.ConclusionThe quality of reports on RCTs investigating scalp acupuncture treatment for stroke was moderate to low. Furthermore, reporting of some items was either insufficient or inadequate in the majority of studies. In order to improve and standardize the quality of RCTs investigating scalp acupuncture for stroke, CONSORT and STRICTA guidelines should be utilized more frequently.Electronic supplementary materialThe online version of this article (10.1186/s12906-017-1950-6) contains supplementary material, which is available to authorized users.

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“…Previous scientific work aiming to evaluate the reliability of biomedical research has been limited by data and methodological issues. Data challenges included the time and resources necessary to assess methods and reporting, resulting in the use of small selected samples and/or limited information available for each scientific article evaluated in larger samples 9–28. As a result, it remains unknown what is the overall magnitude of waste due to inadequate methods and reporting in biomedical research and what factors are associated with the use of adequate vs inadequate research methods.…”

Section: Introductionmentioning

confidence: 99%

Trends and predictors of biomedical research quality, 1990–2015: a meta-research study

Catillon

2019

BMJ Open

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ObjectiveTo measure the frequency of adequate methods, inadequate methods and poor reporting in published randomised controlled trials (RCTs) and test potential factors associated with adequacy of methods and reporting.DesignRetrospective analysis of RCTs included in Cochrane reviews. Time series describes the proportion of RCTs using adequate methods, inadequate methods and poor reporting. A multinomial logit model tests potential factors associated with methods and reporting, including funding source, first author affiliation, clinical trial registration status, study novelty, team characteristics, technology and geography.DataRisk of bias assessments for random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data and selective reporting, for each RCT, were mapped to bibliometric and funding data.OutcomesRisk of bias on six methodological dimensions and RCT-level overall assessment of adequate methods, inadequate methods or poor reporting.ResultsThis study analysed 20 571 RCTs. 5.7% of RCTs used adequate methods (N=1173). 59.3% used inadequate methods (N=12 190) and 35.0% were poorly reported (N=7208). The proportion of poorly reported RCTs decreased from 42.5% in 1990 to 30.2% in 2015. The proportion of RCTs using adequate methods increased from 2.6% in 1990 to 10.3% in 2015. The proportion of RCTs using inadequate methods increased from 54.9% in 1990 to 59.5% in 2015. Industry funding, top pharmaceutical company affiliation, trial registration, larger authorship teams, international teams and drug trials were associated with a greater likelihood of using adequate methods. National Institutes of Health funding and university prestige were not.ConclusionEven though reporting has improved since 1990, the proportion of RCTs using inadequate methods is high (59.3%) and increasing, potentially slowing progress and contributing to the reproducibility crisis. Stronger incentives for the use of adequate methods are needed.

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A retrospective survey of quality of reporting on randomized controlled trials of metformin for polycystic ovary syndrome

Cited by 11 publications

References 31 publications

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

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

Assessing the quality of reports about randomized controlled trials of scalp acupuncture combined with another treatment for stroke

Trends and predictors of biomedical research quality, 1990–2015: a meta-research study

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