Facelift Randomized Controlled Trials Compliance With CONSORT Checklist: A Systematic Review

COMPLIANCE OF RANDOMIZED CLINICAL TRIALS ON DENTAL CARIES PREVENTION METHODS WITH THE CONSORT STATEMENT: A SYSTEMATIC REVIEW

Recommendations for Reporting of Clinical Research Studies

Assessment of the reporting quality of randomized controlled trials related to the pharmacotherapy of COVID-19 based on the CONSORT 2010 checklist: a systematic review

The objective of this study was to determine adherence to the 2010 Consolidated Standards of Reporting Trials (CONSORT) standards for reported randomized controlled trials (RCTs) assessing immunosuppressive medications in the kidney transplant population between 2007 and 2013. The study period was divided into two arms, 2007-2010 and 2010-2013. RCTs were extracted from 3 major databases, and adherence to CONSORT 2010 was evaluated using the CONSORT score. Of the 540 RCTs extracted, 110 were selected for the study, comprising 55 RCTs for each study period. The median CONSORT score was 17. Significant differences between the scores were detected for the periods 2007-2010 and 2010-2013 (p < 0.02). No difference in scores was detected when comparing the RCTs involving induction and maintenance therapy (H statistic = 171.5 and p = 2.8). Regression analysis revealed that the year of publication exhibited a significant relationship with the CONSORT score, but no relationship was observed between the year of publication and the number of authors, the impact factor of the journal or the country of publication. Despite recent improvements, significant underreporting of CONSORT items for randomization, allocation concealment, blinding and maintenance, changes of trial protocol, trial registration and accessibility of the full trial protocol was detected.

ObjectivesTo assess the reporting quality of randomisation and allocation methods in occupational health and safety (OHS) trials in relation to Consolidated Standards of Reporting Trials (CONSORT) requirements of journals, risk...

BackgroundHeart failure with preserved ejection fraction (HFpEF) causes significant cardiovascular morbidity and mortality. Current consensus guidelines reflect the neutral results from randomised controlled trials (RCTs). Adequate trial reporting is a...

The Consolidated Standards of Reporting Trials (CONSORT) statement was developed to improve the reporting quality of randomized controlled trials (RCTs). Our primary aim was to assess to what extent reports of RCTs in solid organ transplantation adhere to the 2010 CONSORT statement. Secondly, we investigated the relationship between CONSORT adherence, methodological quality and some other factors. We included 290 RCTs that were published between 2007 and 2009. We examined to what extent trial reports complied with 30 items of the CONSORT statement. Methodological quality was evaluated using the Jadad scale plus allocation concealment and whether data analysis was by randomized group (intention to treat). On average, trial reports addressed 47% of the CONSORT items. Forty-three per cent of RCTs was considered to be of good quality according to Jadad scale, and the items allocation concealment and data analysis were satisfied in approximately one-third of trials. Good quality RCTs reported on more CONSORT items than poor quality trials. The methodological quality and adherence to the CONSORT statement of RCTs published in journals that endorse the CONSORT statement was superior to those in journals without CONSORT endorsement. Overall compliance with the CONSORT statement and the methodological quality of RCTs in organ transplantation remains unsatisfactory.

Randomized control trials (RCTs) serve as evidentiary support for recommendations underpinning clinical practice guidelines (CPGs) with the goal of optimizing patient care. A knowledge gap exists within scientific literature when evaluating the quality of RCTs used as evidence in the American Academy of Orthopaedic Surgery (AAOS) pediatric CPGs. We aim to evaluate the reporting quality and risk of bias in RCTs underlying AAOS Pediatric CPG recommendations. We located all AAOS Pediatric CPGs. We then extracted all RCTs from the CPG reference sections. All included RCTs were evaluated using the Consolidated Standards of Reporting Trials (CONSORT) checklist and Cochrane Collaboration risk of bias assessment tool (RoB 2.0). Descriptive statistics were recorded, and bivariate analysis was used to account for variance in CONSORT scores. A Mann-Whitney U test was completed to compare CONSORT studies published before and after 2010. Three CPGs and 23 RCTs met inclusion criteria. Mean CONSORT adherence was 69.8% (21.6/31). The lowest adhered to CONSORT items were 10, 23, and 24, while items 2a, 13a, and 18 displayed the highest adherence. Ten RCTs (43.5%, 10/23) had "low" risk of bias, 5 RCTs (21.7%, 5/23) were of "some concerns," and 8 RCTs (34.8%, 8/23) received a "high" designation for risk of bias. There were no statistically significant associations in the bivariate regression analysis or Mann-Whitney U test. Our results suggest that CONSORT adherence within RCTs used as evidence in AAOS Pediatric CPGs is substandard-relying on evidence that, in some cases, is >20 years old. Many of the RCTs cited as supporting evidence have a "high" risk of bias. Altogether, these CPGs may need to be updated or expanded to include more recent evidence relevant to pediatric orthopaedic surgery.

The CONSORT-SPI 2018 extension: a new guideline for reporting social and psychological intervention trials.

Acknowledging the importance of study design in the organization and quality of manuscripts

Reporting is critical for establishing the value of randomized controlled trials (RCTs). This study evaluated the adherence of bariatric surgery RCT reporting to the CONsolidated Standards Of Reporting Trials (CONSORT) statement 2010 and its 2017 extension for non-pharmacologic treatments (NPT extension). We identified all RCTs comparing bariatric surgery with conservational therapy or alternative bariatric surgery up to June 30, 2020. Reporting quality was assessed using criteria developed from the CONSORT statement and the NPT extension and scored as a percentage. The factors associated with reporting quality were explored by univariate and multivariate analysis. In total, 102 RCTs of bariatric surgery were included. The median scores according to the CONSORT statement and NPT extension were 63.3 and 26.8 of a maximum possible 100, respectively. Two-thirds of NPT extension items were reported in less than 25% of the RCTs. The median score improved over time for the CONSORT statement but not the NPT extension. A higher CONSORT score was associated with publication in core clinical journals, protocol registration, and funding. No factors associated with the NPT extension score were identified. Substantial efforts are warranted from authors, journals, registration platforms, and funders to overcome the flaws in the reporting of bariatric surgery RCTs.

Background Although several retrospective and non-randomized studies support reduction of migraine frequency and severity after patent foramen ovale (PFO) closure, three randomized controlled trials (RCTs) in this setting have not met their primary efficacy endpoints. In addition, currently there are is no analysis of the quality of RCTs of percutaneous PFO closure for the treatment of migraine. Purpose The present study aims to determine the reporting quality of RCTs focusing on the PFO closure for the treatment of migraine according to the revised CONsolidated Standards Of Reporting Trials (CONSORT) 2010 checklist. Methods Systematic searches of 2 databases (MEDLINE/PubMed and Cochrane library) were conducted. The search strategy identified reports on RCTs involving patients with migraine and PFO who were randomized to transcatheter device closure of PFO or medical treatment in order to investigate the effect of PFO closure for migraine. The primary objective was to establish the mean CONSORT compliance of RCTs of PFO closure for the treatment of migraine and secondary objectives were the calculation of compliance per CONSORT item and effect of CONSORT statement in high-ranked medical journals. Quality of reporting was assessed using a 37-item questionnaire based on the revised CONSORT 2010 checklist. Reporting above 75% of the items was defined as adequate compliance to the CONSORT statement. Results The search identified 3 eligible articles for analysis. The mean compliance was 69.66% ± 4.49%. Among the studies, only 1 RCT (PRIMA Trial) registered a good reporting quality (75% of the CONSORT items), whereas there were no RCTs with a CONSORT compliance less than 50% (Figure 1). Among assessed items, 19 items (51.4%) were reported in all (100%) of the articles. Also, 26 of the 37 items of the checklist (70.3%) were reported in more than half of the studies. The majority of the Results items registered an adequate reporting whereas randomization items were not so sufficiently reported overall (Figure 2). Each one of the RCTs used in the analysis were published in high-ranked medical journals (IF&amp;gt;30). However, none of the studies reported all 37 items achieving 100% CONSORT compliance score. Conclusions Based on the present results, quality of reporting in RCTs focusing on the PFO closure for the treatment of migraine remains suboptimal according to the CONSORT analysis. In this sense, better designed RCTs on the management of migraine by PFO closure are currently needed to guide future clinical practice.Figure 1.Figure 2.

The reporting of methodological factors in randomized controlled trials and the association with a journal policy to promote adherence to the Consolidated Standards of Reporting Trials (CONSORT) checklist

This evidence mapping (EM) and quality assessment of randomized controlled trials (RCTs) in Dental Traumatology (DT) aimed to identify the RCTs, distribute them in different domains and subdomains, analyze their methodological characteristics, and assess their quality. A protocol was developed as per the principles of Global-Evidence-Mapping (EM) and registered in open-sciences-framework. A systematic electronic search was performed in the PubMed, SCOPUS, EMBASE, Web of Science, LILACS, and COCHRANE on September 30, 2025. Grey literature and reference searches were also performed. RCTs with intervention arms with/without a control group, having details of randomization related to any domain of DT, were included after screening of titles, abstracts, and full-text articles. Studies were distributed in domains and subdomains, and data related to demographic and methodological characteristics were extracted and analyzed. Risk of bias (ROB) was assessed using the Cochrane risk-of-bias tool for randomized trials (RoB-2) and details were presented in the form of an abacus EM plot. The study identified 30 RCTs in four domains of DT, with the highest in the therapeutic domain and subdomain of treatment protocols in permanent dentition. Seven studies were published before 2010, nine between 2010 and 2019, and 14 others from 2020 to date. They represented 13 countries, with the highest from China, the United Kingdom, and India. A protocol was registered in 10 studies, and the majority of the studies had not followed Consolidated Standards of Reporting Trials (CONSORT) guidelines. Only three RCTs were found to have a low ROB. The majority of studies exhibited a lack of methodological robustness in defining their hypothesis, sample size estimation, randomization, and statistical evaluation of outcomes. This was the reason for 27 of them being graded as having high ROB or some concerns. The results of this EM may help researchers in identifying the areas for future research and guide them to follow the best practices in the planning and conduct of RCTs.

In the era of evidence-based practice (EBP), randomized controlled trials (RCTs) may provide the best evidence of the efficacy of nursing interventions and yet the quality of Rct reporting in nursing literature has not been evaluated. The purposes of this study were to apply the Consolidated Standards of Reporting Trials (CONSORT) statement to published reports of nursing science, examine how adequately the published reports adhere to the statement, and examine the effect of the adoption of CONSORT on the quality of the Rct published reports. One hundred RCTs from 2002–2005 were identified from four nursing journals. Articles were randomly assigned to four reviewers and the quality of the published reports was evaluated using a modified CONSORT checklist. There was no difference between the four journals in the quality of the published reports of RCTs based on the modified CONSORT checklist employed (F = 1.27, P = 0.29). The quality of reporting of RCTs improved significantly in the only journal, Nursing Research, to adopt the CONSORT statement during the study period (t = -2.70, P = 0.01). Adoption of CONSORT is recommended as it may lead to an overall improvement in quality of reporting of RCTs in nursing journals. The profession may also wish to explore the use or development of standards similar to CONSORT but ones more appropriate for the types of research typical of that published by nurse scientists.