CONSORT Items Research Articles

Are CONSORT checklists submitted by authors adequately reflecting what information is actually reported in published papers?

BackgroundCompulsory submission of a checklist from the relevant reporting guideline is one of the most widespread journal requirements aiming to improve completeness of reporting. However, the current suboptimal levels of adherence to reporting guidelines observed in the literature may indicate that this journal policy is not having a significant effect.FindingsWe explored whether authors provided the appropriate CONSORT checklist extension for their study and whether there were inconsistencies between what authors claimed on the submitted checklist and what was actually reported in the published paper. We randomly selected 12 randomized trials from three journals that provide the originally submitted checklist and analyzed six core CONSORT items. Only one paper used the appropriate checklist extension and had no inconsistencies between what was claimed in the submitted checklist and what was reported in the published paper.ConclusionJournals should take further actions to take full advantage of the requirement for the submission of fulfilled CONSORT checklists, thus ensuring that these checklists reflect what is reported in the manuscript.

Effect of Camellia sinensis plant on decreasing the level of halitosis: A systematic review

Tea is the second most consumed beverage. Polyphenolic catechins of green tea have a number of beneficial effects in oral cavity. This study aims to evaluate the clinical effects of green tea on halitosis through a systematic review of available literature. All available randomized, clinical trials - with a relevant subject that met the inclusion criteria - were included by searching PubMed, Cochrane, ProQuest, and Google Scholar, and Scopus databases. To score the selected articles, 27 items of CONSORT 2010 checklist were considered. Each article was reviewed by all the authors. Searching the PubMed database yielded 42 articles, 2 of which met the inclusion criteria. None of the 12 articles were obtained through Cochrane library, and 85 articles retrieved from ProQuest database met the inclusion criteria. Three hundred and five articles were obtained from Google Scholar, three of which fulfilled the inclusion criteria. Two articles were omitted because they were duplicated, and the rest were excluded. Searching the Scopus database yielded 270 articles, 2 of which met the inclusion criteria, but they were also duplicated. Finally, two studies were selected according to the inclusion criteria of the study. In both of the included articles, the early effect of green tea use was statistically significant in comparison with baseline. One of the studies showed the long-term effect of green tea mouthwash. Green tea can reduce halitosis through rinsing and antimicrobial effect.

Adherence to CONSORT Items in Randomized Controlled Trials of Integrative Medicine for Colorectal Cancer Published in Chinese Journals

The majority of studies of integrative treatment for colorectal cancer (CRC) have been published in Chinese journals. These studies indicate potential benefits, but concerns have been raised over the quality of trials published in Chinese journals. The CONSORT statement provides a guide for study reporting that has been endorsed by more than 400 international journals. Previous studies have used the CONSORT checklist to assess the quality of randomized controlled trials (RCTs). This study focused on RCTs of integrative and traditional medicine for CRC published in Chinese journals and assessed: (1) the overall quality of reporting with a focus on methodological aspects; (2) change over time; and (3) the influence of study funding, level of institution conducting the trial, rank of the journal, and the length of the article. Searches of seven databases identified RCTs. Quality was assessed using CONSORT 2010 with adaptations to facilitate scoring. Additional codes were added for publication year, hospital rank, report length, and status of the journal. Scores of each checklist item, total scores, and scores for eight items associated with RCT methodology were calculated. Eighty-one studies were included in the main analyses. The RCT methodology subgroup scores were significantly higher in studies: with public funding, conducted by authors from university hospitals, published in higher ranked journals, and in longer articles. Few Chinese journals mention CONSORT in their author guidelines. In these RCTs on CRC better reporting of RCT methodology was associated with ranking of the journal as "core," public funding of the RCT, and first or correspondent author from a university hospital but the quality of reporting had not significantly improved in 15 years. As the volume of scientific information produced in China grows, it is imperative that there is growth in the quality of this information.

In veterinary trials reporting and communication regarding randomisation procedures is suboptimal

To evaluate randomisation mechanisms in the veterinary literature, all trials defined as ‘randomised’ were extracted from five leading veterinary journals for the year 2013. Three blinded investigators evaluated (1) if...

167: CRITICALLY APPRAISE OF THE REPORTING QUALITY OF RANDOMIZED CONTROLLED TRIALS ARTICLES IN THE FIELD OF DIABETES IN MEDICAL GUIDELINES IN IRAN

Background and aims:To determine the quality of randomized controlled clinical trial reports in diabetes research in Iran and their presence in domestic and foreign credible guidelines which can imply whether...

Methodological Quality of Randomized Clinical Trials of Respiratory Physiotherapy in Coronary Artery Bypass Grafting Patients in the Intensive Care Unit: a Systematic Review.

ObjectiveTo assess methodological quality of the randomized controlled trials of physiotherapy in patients undergoing coronary artery bypass grafting in the intensive care unit.MethodsThe studies published until May 2015, in MEDLINE, Cochrane and PEDro were included. The primary outcome extracted was proper filling of the Cochrane Collaboration's tool's items and the secondary was suitability to the requirements of the CONSORT Statement and its extension.ResultsFrom 807 studies identified, 39 were included. Most at CONSORT items showed a better adequacy after the statement's publication. Studies with positive outcomes presented better methodological quality.ConclusionThe methodological quality of the studies has been improving over the years. However, many aspects can still be better designed.

Impact of a web-based tool (WebCONSORT) to improve the reporting of randomised trials: results of a randomised controlled trial.

BackgroundThe CONSORT Statement is an evidence-informed guideline for reporting randomised controlled trials. A number of extensions have been developed that specify additional information to report for more complex trials. The aim of this study was to evaluate the impact of using a simple web-based tool (WebCONSORT, which incorporates a number of different CONSORT extensions) on the completeness of reporting of randomised trials published in biomedical publications.MethodsWe conducted a parallel group randomised trial. Journals which endorsed the CONSORT Statement (i.e. referred to it in the Instruction to Authors) but do not actively implement it (i.e. require authors to submit a completed CONSORT checklist) were invited to participate. Authors of randomised trials were requested by the editor to use the web-based tool at the manuscript revision stage. Authors registering to use the tool were randomised (centralised computer generated) to WebCONSORT or control. In the WebCONSORT group, they had access to a tool allowing them to combine the different CONSORT extensions relevant to their trial and generate a customised checklist and flow diagram that they must submit to the editor. In the control group, authors had only access to a CONSORT flow diagram generator. Authors, journal editors, and outcome assessors were blinded to the allocation. The primary outcome was the proportion of CONSORT items (main and extensions) reported in each article post revision.ResultsA total of 46 journals actively recruited authors into the trial (25 March 2013 to 22 September 2015); 324 author manuscripts were randomised (WebCONSORT n = 166; control n = 158), of which 197 were reports of randomised trials (n = 94; n = 103). Over a third (39%; n = 127) of registered manuscripts were excluded from the analysis, mainly because the reported study was not a randomised trial. Of those included in the analysis, the most common CONSORT extensions selected were non-pharmacologic (n = 43; n = 50), pragmatic (n = 20; n = 16) and cluster (n = 10; n = 9). In a quarter of manuscripts, authors either wrongly selected an extension or failed to select the right extension when registering their manuscript on the WebCONSORT study site. Overall, there was no important difference in the overall mean score between WebCONSORT (mean score 0.51) and control (0.47) in the proportion of CONSORT and CONSORT extension items reported pertaining to a given study (mean difference, 0.04; 95% CI −0.02 to 0.10).ConclusionsThis study failed to show a beneficial effect of a customised web-based CONSORT checklist to help authors prepare more complete trial reports. However, the exclusion of a large number of inappropriately registered manuscripts meant we had less precision than anticipated to detect a difference. Better education is needed, earlier in the publication process, for both authors and journal editorial staff on when and how to implement CONSORT and, in particular, CONSORT-related extensions.Trial registrationClinicalTrials.gov: NCT01891448 [registered 24 May 2013].

Systematic review finds major deficiencies in sample size methodology and reporting for stepped-wedge cluster randomised trials

BackgroundStepped-wedge cluster randomised trials (SW-CRT) are increasingly being used in health policy and services research, but unless they are conducted and reported to the highest methodological standards, they are unlikely...

Quality of reporting randomized controlled trials (RCTs) in diabetes in Iran; a systematic review.

ObjectiveTo determine the quality of randomized controlled clinical trial (RCT) reports in diabetes research in Iran.DesignSystematized review.MethodsWe included RCTs conducted on diabetes mellitus in Iran. Animal studies, educational interventions, and non-randomized trials were excluded. We excluded duplicated publications reporting the same groups of participants and intervention. Two independent reviewers identify all eligible articles specifically designed data extraction form. We searched through international databases; Scopus, ProQuest, EBSCO, Science Direct, Web of Science, Cochrane Library, PubMed; and national databases (In Persian language) such as Magiran, Scientific Information Database (SID) and IranMedex from January 1995 to January of 2013 Two investigators assessed the quality of reporting by CONSORT 2010 (Consolidated Standards of Reporting Trials) checklist statemen.t,. Discrepancies were resolved by third reviewer consulting.ResultsOne hundred and eight five (185) studies were included and appraised. Half of them (55.7 %) were published in Iranian journals. Most (89.7 %) were parallel RCTs, and being performed on type2 diabetic patients (77.8 %). Less than half of the CONSORT items (43.2 %) were reported in studies, totally. The reporting of randomization and blinding were poor. A few studies 15.1 % mentioned the method of random sequence generation and strategy of allocation concealment. And only 34.8 % of trials report how blinding was applied.ConclusionsThe findings of this study show that the quality of RCTs conducted in Iran in diabetes research seems suboptimal and the reporting is also incomplete however an increasing trend of improvement can be seen over time. Therefore, it is suggested Iranian researchers pay much more attention to design and methodological quality in conducting and reporting of diabetes RCTs.Electronic supplementary materialThe online version of this article (doi:10.1186/s40200-016-0258-2) contains supplementary material, which is available to authorized users.

Improving the reporting of randomised pilot and feasibility studies: a consort statement extension

Pilot and feasibility studies underpin much of current health related research, including randomised controlled trials. The number of reports in which authors describe their studies as pilot or feasibility studies is increasing and there is currently a lot of interest in this area. However, in spite of a number of papers that have recommended ways in which the reporting of these studies could be improved, reporting remains poor. Using CONSORT endorsed methodology including a large Delphi study (n=93) and an international consensus meeting (n=26) we have developed a CONSORT extension for randomised pilot and feasibility studies. Much of the existing CONSORT statement for randomised controlled trials does apply to these types of study. However, sometimes the application of the items is different from that in RCTs designed to evaluate the effect of an intervention or therapy and some CONSORT items are not applicable or have needed some alteration. We are currently writing the explanation and elaboration statement for this CONSORT extension. We will present the major issues in reporting these types of randomised studies and use examples to illustrate good and bad practice. This work is part of a larger programme of work on pilot and feasibility studies.

Impact of an online writing aid tool for writing a randomized trial report: the COBWEB (Consort-based WEB tool) randomized controlled trial.

BackgroundIncomplete reporting is a frequent waste in research. Our aim was to evaluate the impact of a writing aid tool (WAT) based on the CONSORT statement and its extension for non-pharmacologic treatments on the completeness of reporting of randomized controlled trials (RCTs).MethodsWe performed a ‘split-manuscript’ RCT with blinded outcome assessment. Participants were masters and doctoral students in public health. They were asked to write, over a 4-hour period, the methods section of a manuscript based on a real RCT protocol, with a different protocol provided to each participant. Methods sections were divided into six different domains: ‘trial design’, ‘randomization’, ‘blinding’, ‘participants’, ‘interventions’, and ‘outcomes’. Participants had to draft all six domains with access to the WAT for a random three of six domains. The random sequence was computer-generated and concealed. For each domain, the WAT comprised reminders of the corresponding CONSORT item(s), bullet points detailing all the key elements to be reported, and examples of good reporting. The control intervention consisted of no reminders. The primary outcome was the mean global score for completeness of reporting (scale 0–10) for all domains written with or without the WAT.ResultsForty-one participants wrote 41 different manuscripts of RCT methods sections, corresponding to 246 domains (six for each of the 41 protocols). All domains were analyzed. For the primary outcome, the mean (SD) global score for completeness of reporting was higher with than without use of the WAT: 7.1 (1.2) versus 5.0 (1.6), with a mean (95 % CI) difference 2.1 (1.5–2.7; P <0.01). Completeness of reporting was significantly higher with the WAT for all domains except for blinding and outcomes.ConclusionUse of the WAT could improve the completeness of manuscripts reporting the results of RCTs.Trial registrationClinicaltrials.gov (http://clinicaltrials.govNCT02127567, registration date first received April 29, 2014)Electronic supplementary materialThe online version of this article (doi:10.1186/s12916-015-0460-y) contains supplementary material, which is available to authorized users.

CONSORT item reporting quality in the top ten ranked journals of critical care medicine in 2011: a retrospective analysis.

IntroductionReporting randomised controlled trials is a key element in order to disseminate research findings. The CONSORT statement was introduced to improve the reporting quality. We assessed the adherence to the CONSORT statement of randomised controlled trials published 2011 in the top ten ranked journals of critical care medicine (ISI Web of Knowledge 2011, Thomson Reuters, London UK).Methods Design. We performed a retrospective cross sectional data analysis. Setting. This study was executed at the University Hospital of RWTH, Aachen. Participants. We selected the following top ten listed journals according to ISI Web of Knowledge (Thomson Reuters, London, UK) critical care medicine ranking in the year 2011: American Journal of Respiratory and Critical Care Medicine, Critical Care Medicine, Intensive Care Medicine, CHEST, Critical Care, Journal of Neurotrauma, Resuscitation, Pediatric Critical Care Medicine, Shock and Minerva Anestesiologica. Main outcome measures. We screened the online table of contents of each included journal, to identify the randomised controlled trials. The adherence to the items of the CONSORT Checklist in each trial was evaluated. Additionally we correlated the citation frequency of the articles and the impact factor of the respective journal with the amount of reported items per trial.ResultsWe analysed 119 randomised controlled trials and found, 15 years after the implementation of the CONSORT statement, that a median of 61,1% of the checklist-items were reported. Only 55.5% of the articles were identified as randomised trials in their titles. The citation frequency of the trials correlated significantly (rs = 0,433; p<0,001 and r = 0,331; p<0,001) to the CONSORT statement adherence. The impact factor showed also a significant correlation to the CONSORT adherence (r = 0,386; p<0,001).ConclusionThe reporting quality of randomised controlled trials in the field of critical care medicine remains poor and needs considerable improvement.

CONSORT item adherence in top ranked anaesthesiology journals in 2011: a retrospective analysis.

Randomised controlled trials (RCTs) are the gold standard for measuring the efficacy of any medical intervention. The present study assesses the implementation of the CONSORT statement in the top 11 anaesthesiology journals in 2011. We designed this study in order to determine how well authors in the top 11 ranked anaesthesiology journals follow the CONSORT statement's criteria. A retrospective cross-sectional data analysis. The study was performed at the RWTH Aachen University Hospital. Journals included Pain, Anesthesiology, British Journal of Anaesthesia, Regional Anesthesia and Pain Medicine, European Journal of Pain, Anesthesia and Analgesia, Anaesthesia, Minerva Anestesiologica, Canadian Journal of Anesthesia, Journal of Neurosurgical Anesthesiology and the European Journal of Anaesthesiology. All articles in the online table of contents from the top 11 anaesthesiology journals according to the ISI Web of Knowledge were screened for RCTs published in 2011. The RCTs were assessed using the CONSORT checklist. We also analysed the correlation between the number of citations and the adherence to CONSORT items. We evaluated 319 RCTs and found that, more than ten years after the publication of the CONSORT statement, the RCTs satisfied a median of 60.0% of the CONSORT criteria. Only 72.1% of the articles presented clearly defined primary and secondary outcome parameters. The number of citations is only weakly associated with the fulfilment of the CONSORT statement (r = 0.023). Adherence to the CONSORT criteria remains low in top-ranked anaesthesiology journals. We found only a very weak correlation between the number of citations and fulfilment of the requirements of the CONSORT statement.

Quality of reporting in infertility journals

To evaluate whether fertility and top gynecology journals indexed in PubMed require the use of reporting guidelines and to identify the percentage of randomized controlled trials (RCTs) published in 2013 that were written following CONSORT guidelines in the top four fertility journals (by their highest impact factor). Cross-sectional study evaluating instructions for authors and RCTs published in fertility journals. Academic institution. None. None. Proportion of instruction-for-authors documents that suggested or required the use of reporting guidelines, and proportion of RCTs published in 2013 that accomplished the CONSORT checklist. In 47% (16/34) of the journals one or more reporting guidelines were mentioned in the instructions for authors' documents. PRISMA and CONSORT were the most commonly mentioned reporting guidelines. None of the analyzed RCTs completed the 25 items of CONSORT guideline. Sequence generation or allocation concealment was not described in 69% of the studies. One-third of the journals did not publish a flowchart, 72% did not show relative and absolute size-effect measures, and 42% did not use measures of imprecision. In the summaries, 42% did not discuss the limitations of the study and 78% did not mention the generalizability of the results. Less than half of the analyzed peer-reviewed journals request the authors to use reporting guidelines. Nevertheless, among the top fertility and gynecology journals, reporting guidelines are widely mentioned. Overall, accomplishment of CONSORT items was suboptimal. Editorial boards, reviewers, and authors should join efforts to improve the quality of reporting.

A survey on the amount of adherence to STARD and CONSORT standards in the abstracts of diagnostic accuracy studies and randomized controlled trials published in International Continence Society abstract book 2011

Purpose : To assess reporting quality of Randomized Controlled Trials (RCTs) and Diagnostic Accuracy Studies (DASs) published in International Continence Society (ICS) abstract book 2011. Methods: Reports of RCTs and DASs published in ICS abstract book 2011 were identified. The proportion of adherence to each item in the Consolidated Standards of Reporting Trials (CONSORT) and STAndards for the Reporting of Diagnostic accuracy studies (STARD) checklists was evaluated for each article abstract by two independent reviewers masked to each other’s results giving one point to each item of the used checklists only if it was clearly defined in the abstract. Results: Out of 287 articles, 67 articles matched our inclusion criteria (37 RCTs and 30 DASs). The mean scores were 10.70 and 15.03 out of 17 and 25 respectively. The highest scored items were items 5 and 15 (INTERVENTION and CONCLUSION) in the CONSORT group (both being reported in 97.3% of articles). In the STARD group, items 2, 3, and 25 (INTRODUCTION, PARTICIPANTS/POPULATION and DISCUSSION) were fully reported. The lowest scored items were item 2 (AUTHORS) in the consort group and item 11 (TEST METHODS/BLINDING) in the diagnostic accuracy group reported in 0% and 13.3% of articles respectively. Conclusions: Our study revealed that the adherence level is moderate in both groups. In a high ranking society like ICS, we do believe that adopting these two tools would improve the reporting quality.

Presentation of continuous outcomes in randomised trials: an observational study

Objective To characterise the percentage of available outcome data being presented in reports of randomised clinical trials with continuous outcome measures, thereby determining the potential for incomplete reporting bias.Design Descriptive...

Effect of editors’ implementation of CONSORT guidelines on the reporting of abstracts in high impact medical journals: interrupted time series analysis

Objective To investigate the effect of the CONSORT for s guidelines, and different editorial policies used by five leading general medical journals to implement the guidelines, on the reporting quality...

Reporting of factorial trials of complex interventions in community settings: a systematic review

BackgroundStandards for the reporting of factorial randomised trials remain to be established. We aimed to review the quality of reporting of methodological aspects of published factorial trials of complex interventions in community settings.MethodsWe searched MEDLINE, EMBASE, PsychInfo and the Cochrane Controlled Trials Register to identify factorial randomised trials of complex interventions in community settings from January 2000 to August 2009. We also conducted a citation search of two review papers published in 2003. Data were extracted by two reviewers on 22 items relating to study design, analysis and presentation.ResultsWe identified 5941 unique titles, from which 116 full papers were obtained and 76 were included in the review. The included trials reflected a broad range of target conditions and types of intervention. The median sample size was 400 (interquartile range 191-1001). Most (88%) trials employed a 2 × 2 factorial design. Few trials (21%) explicitly stated the rationale for using a factorial design. Reporting of aspects of design, analysis or presentation specific to factorial trials was variable, but there was no evidence that reporting of these aspects was different for trials published before or after 2003. However, for CONSORT items that apply generally to the reporting of all trials, there was some evidence that later studies were more likely to report employing an intention-to-treat (ITT) approach (78% vs 52%), present appropriate between-group estimates of effect (88% vs 63%), and present standard errors or 95% confidence intervals for such estimates (78% vs 56%). Interactions between interventions and some measure of the precision associated with such effects were reported in only 14 (18%) trials.ConclusionsReports of factorial trials of complex interventions in community settings vary in the amount of information they provide regarding important methodological aspects of design and analysis. This variability supports the extension of CONSORT guidelines to include the specific reporting of factorial trials.

Reporting randomised clinical trials of analgesics after traumatic or orthopaedic surgery is inadequate: a systematic review

BackgroundSeveral randomised clinical trials (RCTs) of analgesics in postoperative pain after traumatic or orthopaedic surgery (TOS) have been published, but no studies have assessed the quality of these reports. We aimed to examine the quality of reporting RCTs on analgesics for postoperative pain after TOS.MethodsReports of RCTs assessing analgesics in postoperative pain after TOS were systematically searched from electronic databases. The quality of reports was assessed using the CONSORT checklist (scoring range from 0 to 22). The quality was considered poor when scoring was 12 or lesser. The publication year and the impact factor of journals were recorded.ResultsA total of 92 reports of RCTs were identified and 69 (75%) scored 12 or lesser in CONSORT checklist (range 5-17). The mean (SD) CONSORT score of all reports was 10.6 (2.7). Missing CONSORT items included primary and secondary outcome measures (11%), the specific objectives and hypothesis definition (12%), the sample size calculation (12%), the dates defining the periods of recruitment (12%), the discussion of external validity of findings (14%), the allocation sequence generation (24%), and the interpretation of potential bias or imprecision of results (25%). There was a little improvement in CONSORT scores over time (r = 0.62; p < 0.001) and with impact factor of journals (r = 0.30; p < 0.001).ConclusionQuality of reporting RCTs on analgesics after TOS is poor. Reporting of those RCTs should be improved according to methodological standard checklists in the next years.

P01-113 - Venlafaxine for the treatment of depression: a meta-analysis of Chinese trials

ObjectivesChinese trials were rarely included in western meta-analyses. This systematic review investigates the efficacy of venlafaxine in the treatment of major depression (MDD) in Chinese populations.MethodsChinese databases (VIP and CNKI) were searched for blinded randomised clinical trials (RCTs) comparing venlafaxine with any other pharmacotherapy and/or placebo. Quality of included studies was assessed with the Jadad scale. Furthermore, fulfilment of the CONSORT items was recorded. Final mean HAM-D scores and response rates were extracted and combined using a fixed-effects model. Subgroup analyses by drug class were performed to assess further differences.Results23 blinded RCTs were included in the analyses. Six compared venlafaxine with selective serotonin reuptake inhibitors (SSRIs), 15 with tricyclic antidepressants (TCAs) and two with tetracyclic antidepressants. The average Jadad score was 2.7 and on average 55% of all CONSORT items were reported. On average, 36 patients were randomised per group. Only three trials included more than 80 patients per group.Mean final HAMD scores were significantly lower in the venlafaxine groups compared to TCA (Hedges’ g 0.14, 95%-CI, 0.01-0.26), but not in comparison to SSRI treated groups (Hedges’ g 0.05, 95%-CI, -0.12-0.21). These findings were confirmed by analyses of response rates. (MH RR Ven vs. TCA: 1.11, 95%-CI, 1.04-1.18, Ven vs. SSRI: 1.01, 95%-CI, 0.93-1.11).ConclusionsThese results suggest that venlafaxine is significantly more effective than TCAs, but not than SSRIs in depressive Chinese populations. However, large high quality trials are needed to verify these findings.