Assessment of the quality of randomized controlled trials published in Indian Medical Journals from 2020 to 2021: A cross-sectional study

Background: A randomized controlled trial (RCT) is the most valued method for evaluating the drug safety and its efficacy. However, due to incomplete reporting, RCTs may not be a reliable source of information and can lead to false interpretation of outcome. Aim and Objective: The aim of this study was to analyze the completeness in reporting of RCTs published in the Indian medical journals (IMJs) according to the Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist items and to analyze, if there was a variation in the completeness between registered and unregistered trials. Materials and Methods: This was a cross-sectional study conducted in the Department of Pharmacology, Bangalore Medical College and Research Institute. The clinical trials published by the IMJs between January 2020 and August 2021 were accessed online, and its full text versions published were downloaded. Completeness in reporting of the RCTs with respect to different CONSORT checklist domains was recorded. The impact of trial registration and CONSORT endorsement on the completeness of reporting RCTs according to CONSORT checklist was determined. Descriptive statistics was used to assess and summarize the data. Results: The overall completeness of reporting was 82.4%, better than the previous years. Major areas of reporting deficiencies were in the title and abstract, result, and registration domains. Registered trials reported better than unregistered. Conclusions: Endorsement of CONSORT in the journal had no difference in reporting. Although the quality of reporting RCTs in the IMJs has improved, it remains unsatisfactory. Completeness of trial reporting could be improvised by strict implementation of CONSORT guidelines.

Analyzation of expressive elements for clinical RCT of acupuncture and moxibustion:taking peptic ulcer as an example / 中国针灸

To explore the expressive elements for the clinical randomized controlled trials of acupuncture and moxibustion so as to provide reference for them, taking peptic ulcer as an example. Sixty-six papers from 1996 to 2015 were collected in domestic and overseas databases, including China National Knowledge Infrastructure (CNKI), WANFANG, VIP, China Biology Medicine (CBM), PubMed, Web of Science, Sciencedirect, Springer, Wiley. The expression qualities were evaluated according to the Consolidated Standards of Reporting Trials (CONSORT) and the Standards for Reporting Interventions in Clinical Trials of Acupuncture(STRICTA). We consider that the reports are not sound, especially their preface, trial design and intervention.

Impact evaluation of CONSORT and STRICTA guidelines on reporting quality for randomized controlled trials of acupuncture conducted in China / 中国结合医学杂志

<p><b>OBJECTIVE</b>To evaluate and compare the reports' qualities of acupuncture randomized controlled trials (RCTs) conducted in China before and after the implementation of two guidelines, i.e., the Consolidated Standards of Reporting Trials (CONSORT) statement and the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA).</p><p><b>METHODS</b>Proportions of studies that reported CONSORT and STRICTA items were compared for the years before and after implementation of these two guidelines. In addition, the total score of each item's reporting were calculated and reported differences during different date ranges were compared.</p><p><b>RESULTS</b>For CONSORT items (maximum score 8), there was evidence of a slight improvement in reporting between 1994-1995 and 1999-2000 combined (2.5±0.6) and 2004-2005 and 2009-2010 combined (3.0±0.9; difference 0.4, 95% confidence interval, 0.3 to 0.6, P<0.01). For STRICTA items (maximum score 17), there was evidence that a slight improvement in reporting between 1994-1995 and 1999-2000 combined (8.6±2.1) and 2004-2005 and 2009-2010 combined (10.1±1.8; difference 1.5, 95% confidence interval, 1.1 to 1.9, P<0.01).</p><p><b>CONCLUSION</b>Quality of reporting for RCTs of acupuncture treatment conducted in China have generally improved since the introduction of the STRICTA and CONSORT guidelines.</p>

Quality of reporting of randomized controlled trials in ten academic Indian dental journals.

Background: Biased results from poorly reported trials can mislead decision‑making in health care at all levels, from treatment decisions for the individual patient to formulation of national public health policies. Objective: To evaluate the quality of reporting of randomized controlled trials (RCTs) in ten Indian dental journals over the period 2011–2012. Materials and Methods: This study included all RCTs published as full‑text articles reported in ten Indian dental journals over the period from 2011 to 2012. The relevant trials were identified by searching Medline. Hand searching of the journals was also carried out by three of the authors to check if any potential trial was missing. Each article was assessed against the Consolidated Standards of Reporting Trials criteria tool, as described by Schulz et al. (2010). Results: The mean number of criteria present per article was 12.2 (standard deviation [SD] =2.2) and only 5 of 106 articles got total possible score. Most of the articles (69%) did not mention about justification for sample size calculation, 89% of the articles did not mention about allocation concealment, 86% of the articles did not mention about funding and 63% of the articles did not mention about limitations of the study. Conclusion: The quality of reporting of Randomized clinical trials in ten Indian academic journals was poor.

Assessment of the reporting quality of ophthalmic diseases related randomized controlled trials published in SCI journals from mainland China / 中华实验眼科杂志

Background Randomized controlled trial (RCT) can offer high quality of evidence for the medical decisions.Consolidated standards of reporting trials (CONSORT) statement,an international criteria for RCT report,is a guideline and methodology of RCT report.However,the assessment and application of RCT according to CONSORT are dissatisfactory in China.Objective This study was to evaluate the reporting quality of ophthalmic diseases related RCTs published in SCI journals from mainland China and offer a good methodology of RCT report.Methods The RCT literature were searched on PubMed database according to Ophthalmology, Eye and all of their inferior subjective terms,and the published papers were limited in mainland China and before March,2013.Included papers were evaluated independently and checked by two searchers.The methodology and results of all retrieved papers were stratifiedly analyzed by the year of CONSORT published and revised.Results Sixty eligible RCTs were assessed,and the intervention methods were primarily surgery trials (34/60).Forty-four papers presented the comparison study of two groups with the median sample size of 76.0.Only 22％ (13/60) trial reports gave the clear identification of RCT in the title.Majority of papers described trial design,eligibility criteria for participants,detail of interventions and outcome measures.Twelve pieces of articles reported how sample size was determined,and 41 pieces referred settings and locations,but only 6 pieces recorded interim analyses and stopping guidelines.After CONSORT 2010 Statement was published,the proportion of trial reports that included details of the randomization had little improvement (RR=1.06,95％ CI:0.62-1.82).Only 42％ trial reports (25/60) offered a description about blinding method.Conclusions RCT reports related to ophthalmic diseases from mainland China in SCI journals are still flawed with certain shortcomings.Following the guidance of the CONSORT statement can improve the quality of ophthalmic diseases related RCT from mainland China.