Consolidated Standards For Reporting Of Trials Statement Research Articles

Quality reporting of randomized controlled trials on SGLT2 inhibitors for heart failure: a comprehensive assessment

Randomised controlled trials (RCTs) provide clinicians with the best evidence of the effectiveness of an intervention, and complete and transparent trial reports help to critically assess and use trial results. The objective of our study was to assess the quality of reporting in RCTs of sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for heart failure (HF) and identify factors associated with improved reporting quality. Two researchers conducted a comprehensive search in four databases (PubMed, Web of Science, EMBASE, and Cochrane). The quality of each report was assessed using a 25-point Overall Quality Score (OQS) based on the guidelines provided in the 2010 Consolidated Standards for Reporting of Trials (CONSORT) statement. We included a total of 58 relevant RCTs. The median OQS in the 2010 CONSORT statement was 15 (range 7.5–24). The missing items were primarily found in the 'Methods' and 'Results' sections of the 2010 CONSORT statement. Multivariate regression modeling revealed that a more recent publication year, high impact factor, and large sample size were significant predictors of OQS improvement. The findings suggest that the overall quality of reported RCTs of SGLT2 inhibitors in HF is unsatisfactory, which reduces their potential usefulness.

Reporting quality of RCTs of acupuncture for vascular dementia

To evaluate the reporting quality of randomized controlled trials (RCTs) of acupuncture for vascular dementia. The RCTs of acupuncture for vascular dementia were systematically retrieved from the Cochrane Library, PubMed, EMbase, CNKI, SinoMed, VIP and Wanfang databases from the date of establishment to October 31, 2018. The reporting quality of RCT was evaluated based on the internationally-recognized Consolidated Standards for Reporting of Trials (CONSORT) statement and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA). A total of 33 RCTs were included. According to the CONSORT statement, 12 items had a reporting rate of 0%, including important changes to methods after trial commencement, sample size, blind method, trial registry, etc.; 5 items had a reporting rate of below 10%, including trial design, type of randomization, random allocation sequence, randomization implementation and participant flow. The reporting rate was 36.36% for baseline data and 57.58% for randomization sequence generation. According to the STRICTA statement, the reporting rate was 21.21% for description of acupuncture depth, 60.61% for description of acupuncture response, 27.27% for description of additional intervention details and 0% for qualification of acupuncturists, respectively. At present, the reporting quality of RCTs of acupuncture for vascular dementia is generally low. In the future, the RCTs of acupuncture for vascular dementia should be normatively reported according to the CONSORT statement and STRICTA statement.

Reporting quality of randomized controlled trials of acupuncture for cancer pain

Based on the internationally-recognized Consolidated Standards for Reporting of Trials (CONSORT) statement and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA), the reported quality of randomized controlled trials (RCTs) of acupuncture for cancer pain during last 10 years were evaluated. The RCTs of acupuncture for cancer pain were searched by computer. The English databases included PubMed and EMbase while the Chinese databases included CNKI, Wanfang, VIP and SinoMed. The publication date of the literature was from March 2009 to March 2019. As a result, 22 Chinese RCTs and 13 English RCTs were included. According to the CONSORT statement, among the Chinese studies, 1 RCT reported primary and secondary outcomes, 8 RCTs reported randomization, none of RCTs reported allocation concealment and blind method, and 4 RCTs reported baseline data; among the English studies, 8 RCTs reported primary and secondary outcomes, 8 RCTs reported randomization, 6 RCTs reported described allocation concealment, 7 RCTs reported blind method, and 13 RCTs reported baseline data. According to the STRICTA statement, among the Chinese studies, 17 RCTs reported the name of acupoints, 6 RCTs reported depth of insertion, 17 RCTs reported acupuncture response sought, and none of RCTs reported the qualifications of acupuncturists; among the English studies, 12 RCTs reported the name of acupoints, 7 RCTs reported depth of insertion, 8 RCTs reported acupuncture response sought, and 7 RCTs reported the qualifications of acupuncturists. The Chinese RCTs have more detailed description of acupuncture intervention and theory, but not enough attention is paid to methodological description such as randomization, blindness, data analysis. On the other hand, the English RCTs have better description of methodology, but the description of theory and details of acupuncture is relatively weak. It is concluded that more efforts were needed to further improve the clinical trial design according to the CONSORT statement and STRICTA statement to improve the quality of clinical evidence.

Endorsement of CONSORT by Chinese medical journals: a survey of "instruction to authors".

To determine the extent to which Chinese medical (CM) journals incorporate Consolidated Standards for Reporting of Trials (CONSORT) into their "instruction to authors". We reviewed the latest "instruction to authors" of the CM journals in China which indexed by MEDLINE in 2010 or Excerpta Medica Database (EMBASE) in 2012 and extracted all information of CONSORT, International Committee of Medical Journal Editors (ICMJE), other reporting guidelines or clinical trial registration. By reading the instructions to authors and reviewing recent studies published in those journals, those that do not publish clinical trials were excluded. We also contacted each of journals by telephone on contributor's status to ask them whether mentioned CONSORT in their instructions and incorporated it into their editorial and peer-review process. Full-text papers of randomized controlled trials (RCTs, from January 2011 to March 2012) published in the journals which mentioned "CONSORT" in their instructions for authors were downloaded. Seven CM journals were included. Three of these journals mentioned CONSORT in its instructions. By telephone survey, all journals gave responses and all respondents knew CONSORT statement. Three of 7 journals required authors to comply with the CONSORT statement and provide the CONSORT checklist and a flow chart of the trial. The rest 4 journals recommended authors of RCTs to refer to the CONSORT statement. From January 2011 to March 2012, a total of 50 RCTs were obtained from the 3 journals endorsing the CONSORT statement; 17 (17/50, 34%) contained a flow diagram in their manuscript, and none of those RCTs had mentioned the trial registration information. The endorsement of CONSORT by CM journals' "instruction to authors" was not satisfactory. The spread of CONSORT endorsement should be wider in instructing the performance of CM clinical trials in the future. Chinese journals should introduce CONSORT to their authors and require authors to comply with CONSORT when they submit their research.

Assessment of the quality of clinical therapeutic research published in Chinese Journal of Pediatrics

To evaluate the methodological qualities of clinical therapeutic research papers published in Chinese Journal of Pediatrics and find out the weaknesses and defects in the literature of clinical therapeutic research in China. The clinical therapeutic research articles from Chinese Journal of Pediatrics, which were published in the years 1999, 2000, 2001, 2009, 2010 and 2011, were analyzed manually, after dividing into randomized controlled trials (RCT) and non-randomized controlled trials. The methodological quality of RCT articles were evaluated by Consolidated Standards for Reporting of Trials (CONSORT) and Jadad scale, while non-RCT reports were assessed by specific evaluation standard criteria and analytical table. And the group A (1999 - 2001) and group B (2009 - 2011) of the quality documents were compared and analyzed. Seventeen RCTs were included. Based on the items in the CONSORT statement, the reporting quality of sample size determination, demographic baseline, random principle, blinding, lost to follow-up were all lower than 50%. Fourteen (82.4%) in the 17 RCTs mentioned 'eligibility criteria for participants', 11 (64.7%) RCTs mentioned 'details of the interventions', 15 (88.2%) RCTs mentioned 'adverse effects'. Compared with RCT reports in the year of 1999, 2000 and 2001, the methodological qualities of those in 2009, 2010 and 2011 were not improved. In the 17 RCTs, the total score achieved based on the Jadad scale, only 11.8% (2 out of 17) were high-quality trials (≥ 3 points). Analysis of the 28 non-RCTs, which were included and assessed by evaluation criteria and evaluation table, also showed some disadvantages on some key items. The methodological quality of clinical therapeutic research reports should be consistent with the standards of international evaluation, pediatric clinicians should improve know ledge in clinical epidemiology, clinical trial methodology, and improve the quality of research reports.

Randomized trials, systematic reviews, meta-analyses: basic criteria in the world of scientific evidence

Under ordinary circumstances choosing the best treatment for each individual patient is a challenging issue. This choice should be based on three main aspects: the patients' psychopathological status, the clinical experience and the best scientific knowledge available regarding efficacy and safety of each treatment. The approach that integrates these three aspects is known as Evidence Based Medicine (EBM). The aim of this report is to present the main methodological features of what constitutes an evidence base, in order to assist mental health professionals in the compelling world of scientific evidence. We describe randomized controlled trials as a tool for evaluating the efficacy and tolerability of treatments, systematic reviews of randomized trials, and meta-analysis, a statistical technique that allows to calculate a weighted pooled estimate of treatment efficacy and tolerability. Finally we will describe two standardized tools for assessing quality of evidence, the CONSORT (Consolidated Standards for Reporting of Trials) statement and the GRADE (Grading of Recommendations Assessment, Development and Evaluation).

Assessing the quality of reports about randomized controlled trials of acupuncture treatment on mild cognitive impairment.

ObjectiveTo evaluate the reports' qualities which are about randomized controlled trials (RCTs) of acupuncture treatment on Mild Cognitive Impairment (MIC).MethodsNine databases including the Cochrane Central Register of Controlled Trials (CENTRAL,2010), PUBMED (1984-5/2010), EMbase (1984-5/2010), MEDLINE (1984-5/2010), CINAL (1984-5/2010), China National Knowledge Infrastructure (CNKI, 1980-5/2010), China Biomedicine Database disc (CBMdisc, 1980-5/2010), VIP (a full text issues database of China, 1989-5/2010) were searched systematically. Hand search for further references was conducted. Language was limited to Chinese and English. We identified 14 RCTs that used acupuncture as an intervention and assessed the quality of these reports against the Consolidated Standards for Reporting of Trials (CONSORT) statement and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA).ResultsIn regard to the items in the CONSORT statement, 13(92.86%) RCTs described baseline demographic and clinical characteristics in each group. 7 (50.0%) mentioned the method of generating the random sequence, only 2 (14.3%) RCTs had adequate allocation concealment. No RCTs used blinding. RCTs reported the sample size calculation. In regard to the items in STRICTA, 10 (71.43%) mentioned the depths of insertion, 6 (42.86%) reported acupuncture response, 11 (78.57%) mentioned the technique of acupuncture, 12 (85.71%) recorded the time, and only 3 (21.43%) RCTs reported the numbers of needles inserted. No RCTs reported the background of the acupuncture practitioners and professional title of practitioners.ConclusionThe reporting quality of RCTs of acupuncture for mild cognitive impairment was moderate to low. The CONSORT statement and STRICTA should be used to standardize the reporting of RCTs of acupuncture in future.

Current situation on the reporting quality of randomized controlled trials in 5 leading Chinese medical journals

Objective The Consolidated Standards for Reporting of Trials (CONSORT) statement has already proved to be an efficient standard for reporting quality of randomized controlled trials (RCTs). However, most of the Chinese medical journals have not endorsed the CONSORT statement. The current situation about the reporting quality of RCTs in Chinese medical journals is still unclear. The purpose of the study was to evaluate the reporting quality of RCTs on papers published in 5 leading Chinese medical journals. Methods We evaluated 232 original RCT papers using a reporting quality scale based on CONSORT statement from 2001 to 2006 in 5 Chinese medical journals (Journal type 1) without adoption of CONSORT and Chinese Journal of Evidence-based Medicine (Journal type 2) which adopted CONSORT in 2004. We measured the inclusion of 26 items for the reporting quality scale and 6 core items of each RCT report, gave score to each item and calculated the total score obtained in each report and the proportion of reports including individual items. The reporting quality of RCT trials from 2001 to 2003 (pre-adoption period) was compared with that from 2004 to 2006 (post-adoption period). Results The average reporting quality of RCTs was moderate (mean score, 15.18), and the mean score of the 6 core items was low (mean score, 1.09) in 5 leading journals. The difference in the total score and the score of the 6 core items between pre-adoption period (2001–2003) and post-adoption period (2004—2006) was statistically significant ( P=0.003; P=0.000). Interaction between journal type and period was not significant ( F=0.76; P=0.383). We concluded that the change tendency of reporting quality between Journal type 1 and 2 was not different. But as to the core items of sequence concealment and intention-to-treat analysis, the increases were greater for Journal type 2 when evaluated against Journal type 1 ( P=0.038; P=0.016). Conclusion The reporting quality of RCT trials in 5 leading Chinese medical journals is improving. However, the lack of important items in RCT trials remains a serious problem. We recommend the endorsement of the Consolidated Standards for Reporting of Trials statement in Chinese medical journals and the continuing education on evidence-based medicine in China.

Quality of Reports on Randomized Controlled Trials Conducted in Japan: Evaluation of Adherence to the CONSORT Statement

The Consolidated Standards for Reporting of Trials (CONSORT) statement was developed to improve the quality of randomized controlled trial (RCT) reports. We assessed the quality of current Japanese RCT reports by conducting a cross-sectional study to examine the extent to which they adhere to the CONSORT statement. Reports of RCTs conducted in Japan that were published in medical journals between January and March 2004 were sampled from MEDLINE. The proportion of adherence to each item in the CONSORT checklist was evaluated for each report. Additionally, information on ethics reporting and funding sources was collected. A total of 98 RCT reports from Japan were evaluated, and adherence to the CONSORT statement was found to be suboptimal. Only 6 of 29 items in the checklist were described in more than 80% of reports. Adherence to key methodological items of the CONSORT statement was as follows: 23% for sample size determination, 39% for random sequence generation, 17% for allocation concealment, 29% for blinding, 53% for numbers analyzed, and 6% for inclusion of a flow diagram. Adherence to additional items was 82% for ethics committee approval, 92% for receiving informed consent, and 20% for disclosing funding sources. Our study on adherence of recent RCT reports from Japan to the CONSORT statement reveals that there is a significant need for improvement. Further investigation on the quality of RCT reports and ways to improve reporting quality is required.

Chinese authors do need CONSORT: Reporting quality assessment for five leading Chinese medical journals

ObjectiveOnly a few Chinese medical journals have recommended CONSORT in their “Instruction for authors or Guide for authors”. This study aims to evaluate the reporting quality of randomized controlled trials (RCTs) published in the five leading Chinese medical journals indexed by MEDLINE. MethodsWe identified RCTs published from 2004 to January 2007 in five leading Chinese medical journals by searching three important Chinese databases systematically, namely CNKI (China National Knowledge Infrastructure/Chinese Academic Journals full text Database), VIP (a full text database of China) and CBM disc (China Biomedicine Database Disc) and assessed the quality of each RCT by using the Consolidated Standards for Reporting of Trials (CONSORT) and the 5-point Jadad scale. ResultsOne hundred and forty two RCTs were included. Based on the items in the revised CONSORT statement, 130 (91.55%) of the 142 RCTs mentioned “randomization” in the title or abstract, but only 38 (26.76%) RCTs described the method to generate the random sequence; only 6 RCTs had adequate allocation concealment; 24 (17.61%) RCTs mentioned “masking”, but only 7 described the process of masking. Three out of 40 items were reported clearly in all included trials, while five items were not mentioned at all. The quality of RCTs was low as assessed by the Jadad scale and 22 RCTs were high-quality research (≥3 points). ConclusionsThe reporting quality of RCTs published in the five leading Chinese medical journals is low. Chinese journals should adopt the CONSORT statement to improve the reporting quality of Chinese randomized controlled trials.

What is the quality of reporting in weight loss intervention studies? A systematic review of randomized controlled trials

Despite the large number of randomized controlled trials (RCTs) assessing weight loss interventions, no study has assessed the quality of reporting in these trials. To assess the quality of reporting of RCTs of weight loss interventions and to identify predictors of reporting quality. The RCTs assessed were derived from a published systematic review of trials investigating the efficacy of weight loss interventions. For our study, two reviewers independently rated the quality of reporting in these trials, based on the Consolidated Standards for Reporting of Trials (CONSORT) Statement. We describe the quality of reporting using number (percent) of studies satisfying each of the 44 CONSORT criteria. We use generalized estimating equations (GEE) to fit a multivariable regression model to determine factors that are associated with the overall quality reporting score. We assessed 63 RCTs, of which 25 were dietary-lifestyle trials, 22 were pharmacological trials and 16 were behavior-cognitive, exercise-lifestyle, or surgical trials. Less than half (46%) of the trials defined the primary outcome of the study; about 10% provided the description of the method of allocation concealment. Multivariable GEE results showed that the sample size, type of intervention (non-pharmacologic trials having lower scores than pharmacologic trials), and publication time relative to the CONSORT Statement publication in 1996 (publications after 1996 having higher scores) were strong predictors of the quality reporting score. Reporting a statistically significant result on the primary outcome was not significantly associated with the quality score. While the overall quality in reporting seemed to have improved since the publication of the revised CONSORT Statement in 1996, the reporting of some key methodologic aspects, such as clear description of primary outcome and method of allocation concealment, still requires improvements. Factors that are significantly associated with the overall quality reporting score can be used as surrogates in the review of protocols to enhance the quality of the final reports.