Evaluation of reporting quality of abstracts of randomized controlled trials regarding patients with COVID-19 using the CONSORT statement for abstracts.
Ontology highlight
ABSTRACT: Objective
To evaluate the reporting quality of randomized controlled trial (RCT) abstracts regarding patients with COVID-19 and analyse the influence factors.Methods
PubMed, Embase, Web of Science and the Cochrane Library databases were searched to collect RCTs regarding patients with COVID-19. The retrieval time was from the inception to December 1, 2020. The CONSORT statement for abstracts was used to evaluate the reporting quality of RCT abstracts.Results
53 RCT abstracts were included, the CONSORT statement for abstracts showed that the average reporting rate of all items was 50.24%, the lower reporting quality of items were mainly trial design and the details of randomization and blinding (<10%). Mean overall adherence score across all studies was 8.68±2.69 (ranged: 4-13.5). The multivariate linear regression analysis showed the higher reporting scores were associated with higher journal impact factor (P<0.01), international collaboration (P=0.04) and structured format (P<0.01).Conclusions
Although many RCTs regarding patients with COVID-19 have been published in different journals, the overall reporting quality of the included RCT abstracts was suboptimal, thus diminishing their potential usefulness, and this may mislead clinical decision-making. In order to improve the reporting quality, it is necessary to promote and actively apply the CONSORT statement for abstracts.
SUBMITTER: Yin Y
PROVIDER: S-EPMC8736283 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:ObjectiveTo evaluate the reporting quality of randomized controlled trials (RCTs) regarding patients with COVID-19 and analyse the influence factors.MethodsPubMed, Embase, Web of Science and the Cochrane Library databases were searched to collect RCTs regarding patients with COVID-19. The retrieval time was from the inception to December 1, 2020. The CONSORT 2010 statement was used to evaluate the overall reporting quality of these RCTs.Results53 RCTs were included. The study showed that the average reporting rate for 37 items in CONSORT checklist was 53.85% with mean overall adherence score of 13.02±3.546 (ranged: 7 to 22). The multivariate linear regression analysis showed the overall adherence score to the CONSORT guideline was associated with journal impact factor (P = 0.006), and endorsement of CONSORT statement (P = 0.014).ConclusionAlthough many RCTs of COVID-19 have been published in different journals, the overall reporting quality of these articles was suboptimal, it can not provide valid evidence for clinical decision-making and systematic reviews. Therefore, more journals should endorse the CONSORT statement, authors should strictly follow the relevant provisions of the CONSORT guideline when reporting articles. Future RCTs should particularly focus on improvement of detailed reporting in allocation concealment, blinding and estimation of sample size.
| S-EPMC8460279 | biostudies-literature
Project description:Background:Randomized controlled trials (RCTs) are the cornerstone of modern medical research, and their reporting may not always be optimal. The Consolidated Standards of Reporting Trials (CONSORT) statement is an evidence-based means to improve the quality of RCTs' reporting by providing a checklist of recommended items.The aim of this study was to assess the reporting quality of published RCTs on the restless legs syndrome (RLS), based on a checklist arising from the CONSORT statement. Methods:Medical electronic databases were searched for RCTs involving patients with RLS. Inclusion criteria were follows: articles must have been published in English and RLS patients must have been randomized into a minimum of two treatment cohorts of different medicinal orientations. CONSORT-recommended items were marked as "reported" or "not reported," and an overall CONSORT compliance metric was calculated. Comparisons among different time periods, CONSORT-endorsing and non-endorsing, and different levels of impact factor journals were made. Results:Fifty-four eligible trials, published in 21 different scientific journals, were found. The average CONSORT compliance score was 56.6% (23.68-84.21%). CONSORT-endorsing journals had a mean CONSORT compliance of 58.47%, whereas non-endorsing journals had a mean CONSORT compliance of 50.4%. The median CONSORT compliance for articles published in low- (IF<2), medium- (IF 2-7), and high-ranked (IF>7) journals was 52.63, 56.57, and 59.21%, respectively. Only 14 of the 38 CONSORT items (36.8%) were reported in >75% of the articles. Discussion:This study shows that the reporting of RLS-related RCTs is suboptimal, regardless of the time period, the quality of the publishing journal, and the endorsing or non-endorsing of the CONSORT statement.
| S-EPMC6691606 | biostudies-literature
Project description:BACKGROUND:Adequate reporting is crucial in full-text publications but even more so in abstracts because they are the most frequently read part of a publication. In 2008, an extension for abstracts of the Consolidated Standards of Reporting Trials (CONSORT-A) statement was published, defining which items should be reported in abstracts of randomized controlled trials (RCTs). Therefore, we compared the adherence of RCT abstracts to CONSORT-A before and after the publication of CONSORT-A. METHODS:RCTs published in the five surgical journals with the highest impact factor were identified through PubMed for 2005-2007 and 2014-2016. Adherence to 15 CONSORT-A items and two additional items for abstracts of non-pharmacological trials was assessed in duplicate. We compared the overall adherence to CONSORT-A between the two time periods using an unpaired t test and explored adherence to specific items. RESULTS:A total of 192 and 164 surgical RCT abstracts were assessed (2005-2007 and 2014-2016, respectively). In the pre-CONSORT-A phase, the mean score of adequately reported items was 6.14 (95% confidence interval [CI] 5.90-6.38) and 8.11 in the post-CONSORT-A phase (95% CI 7.83-8.39; mean difference 1.97, 95% CI 1.60-2.34; p?<?0.0001). The comparison of individual items indicated a significant improvement in 9 of the 15 items. The three least reported items in the post-CONSORT-A phase were randomization (2.4%), blinding (13.4%), and funding (0.0%). Specific items for non-pharmacological trials were rarely reported (approximately 10%). CONCLUSION:The reporting in abstracts of surgical RCTs has improved after the implementation of CONSORT-A. More importantly, there is still ample room for improvement.
| S-EPMC6722149 | biostudies-literature
Project description:ObjectiveTo explore the methods for improving the reporting quality of randomised controlled trials (RCTs) on acupuncture through evaluating the reporting quality in RCTs of acupuncture for acute herpes zoster by the CONSORT statement and STRICTA guidelines.MethodsEnglish and Chinese databases were searched from database creation until October 2018 and updated to July 2019. The basic characteristics and methodological quality of the literatures included were evaluated based on the CONSORT statement and the STRICTA guidelines. Descriptive statistical analysis was used in this study. The agreement between the two researchers of all items was calculated by Cohen's kappa statistics.ResultsA total of 40 RCTs were included. Based on the CONSORT statement, items "Background," "Randomised" in the title or abstract," "Statistical methods," and "Outcomes and estimation" were good reporting, with positive rates >80%. However, the quality of reporting in items "Sample size," "Allocation concealment," "Implementation," "Blinding," "Flow chart," "Intent-to-treat analysis," "Ancillary analyses," and "Clinical Trials Register" was very poor, with positive rates <10%. Based on the STRICTA guidelines, good reporting existed in items "Acupuncture rational," "Points used," "Needle stimulation," "Needle retention time," "Course of treatment," "Control intervention," and "Treatment frequency," with positive ratings >80%. The reporting quality of items "Numbers of needles inserted," "Depth of insertion," "Responses elicited," and "Practitioner background" was lower, with positive rates <50%. The agreement of most items was judged as moderate, substantial, or good.ConclusionThe reporting quality of RCTs in acupuncture for acute HZ is generally inadequate. It is necessary that researchers and journal editors learn and raise the adoption of the CONSORT statement and STRICTA guidelines to enhance the reporting quality of the RCTs in acupuncture.
| S-EPMC7049440 | biostudies-literature
Project description:BackgroundClear, transparent, and sufficiently detailed abstracts of conferences and journal articles related to randomized controlled trials (RCTs) are important, because readers often base their assessment of a trial solely on information in the abstract. Here, we extend the CONSORT (Consolidated Standards of Reporting Trials) Statement to develop a minimum list of essential items, which authors should consider when reporting the results of a RCT in any journal or conference abstract.Methods and findingsWe generated a list of items from existing quality assessment tools and empirical evidence. A three-round, modified-Delphi process was used to select items. In all, 109 participants were invited to participate in an electronic survey; the response rate was 61%. Survey results were presented at a meeting of the CONSORT Group in Montebello, Canada, January 2007, involving 26 participants, including clinical trialists, statisticians, epidemiologists, and biomedical editors. Checklist items were discussed for eligibility into the final checklist. The checklist was then revised to ensure that it reflected discussions held during and subsequent to the meeting. CONSORT for Abstracts recommends that abstracts relating to RCTs have a structured format. Items should include details of trial objectives; trial design (e.g., method of allocation, blinding/masking); trial participants (i.e., description, numbers randomized, and number analyzed); interventions intended for each randomized group and their impact on primary efficacy outcomes and harms; trial conclusions; trial registration name and number; and source of funding. We recommend the checklist be used in conjunction with this explanatory document, which includes examples of good reporting, rationale, and evidence, when available, for the inclusion of each item.ConclusionsCONSORT for Abstracts aims to improve reporting of abstracts of RCTs published in journal articles and conference proceedings. It will help authors of abstracts of these trials provide the detail and clarity needed by readers wishing to assess a trial's validity and the applicability of its results.
| S-EPMC2211558 | biostudies-literature
Project description:Randomised Controlled Trials (RCTs) are the preferred study design when comparing therapeutical interventions in medicine. To improve clarity, consistency and transparency of reporting RCTs, the Consolidated Standards of Reporting Trials (CONSORT) statement was developed.(1) To assess the quality of reports and abstracts of RCTs in otorhinolaryngologic literature by using CONSORT checklists, (2) to compare the quality of reports and abstracts of otorhinolaryngologic RCTs between the top 5 general medical journals and top 5 otorhinolaryngologic journals, and (3) to formulate recommendations for authors and editors of otorhinolaryngologic ('ENT') journals.Based on 2012 ISI Web of Knowledge impact factors, the top 5 general medical and ENT journals were selected. On 25 June 2014, using a highly sensitive Cochrane RCT filter and ENT filter, possibly relevant articles since January 1st, 2010 were retrieved and relevant RCTs were selected. We assessed how many CONSORT items were reported adequately in reports and abstracts and compared the two journal types.Otorhinolaryngologic RCTs (n = 15) published in general medical journals reported a mean of 92.1% (95% confidence interval: 89.5%-94.7%) of CONSORT items adequately, whereas RCTs (n = 18) published in ENT journals reported a mean of 71.8% (66.7%-76.8%) adequately (p < 0.001). For abstracts, means of 70.0% (63.7%-76.3%) and 32.3% (26.6-38.0%) were found respectively (p < 0.001). Large differences for specific items exist between the two journal types.The quality of reporting of RCTs in otorhinolaryngologic journals is suboptimal. RCTs published in general medical journals have a higher quality of reporting than RCTs published in ENT journals. We recommend authors to report their trial according to the CONSORT Statement and advise editors to endorse the CONSORT Statement and implement the CONSORT Statement in the editorial process to ensure more adequate reporting of RCTs and their abstracts.
| S-EPMC4368673 | biostudies-literature
Project description:BackgroundRandomized controlled trials (RCTs) represent the best evidence in oncology research. Glioblastoma is the most frequent and deadly primary brain tumor, affecting health-related quality of life. An important end point is patient-reported outcomes (PROs). There are no data regarding how well publications of glioblastoma RCTs report PROs. A specific PRO extension of the Consolidated Standards of Reporting Trials (CONSORT) statement was created to improve the quality of reporting. The aim of this study was to evaluate adherence to the CONSORT-PRO statement in reporting RCTs addressing the treatment of patients with glioblastoma. PRO analysis methodology was explored and criteria associated with higher quality of reporting were investigated.MethodsFrom PubMed/MEDLINE and the Cochrane Library databases, all phase 2 and 3 RCTs related to glioblastoma published between 1995 and 2018 were reviewed according to the CONSORT-PRO statements. An overall quality score on a 0 to 100 scale was defined based on these criteria and factors associated with this score were identified.ResultsForty-four RCTs were identified as relevant according to predefined criteria. The median overall quality score was 26. No difference was observed regarding reporting quality over the years. CONSORT-PRO items concerning data collection and analysis were poorly reported. Thirty-four trials (77%) used longitudinal data. The most frequent statistical method for PROs analysis was the mean change from baseline (63%). Factors associated with improved overall quality score were the presence of a secondary publication dedicated to PROs results, the statement of any targeted dimensions, and when trials reported results using multiple methods.ConclusionDespite the importance of measuring PROs in patients with glioblastoma, employment of the CONSORT-PRO statement is poor in RCTs.
| S-EPMC8049443 | biostudies-literature
Project description:Reporting quality of randomized controlled trial (RCT) abstracts is important as readers often make their first judgments based on the abstracts. This study aims to assess the reporting quality of psychiatry RCT abstracts published before and after the release of Consolidated Standards of Reporting Trials for Abstracts (CONSORT-A) guidelines.MEDLINE/PubMed search was conducted to identify psychiatric RCTs published during 2005-2007 (pre-CONSORT) and 2012-2014 (post-CONSORT). Two independent reviewers assessed abstracts using a 18-point overall quality score (OQS) based on the CONSORT-A guidelines. Linear regression analysis was conducted to analyze factors associated with reporting quality.Among 1,927 relevant articles, 285 pre-CONSORT and 214 post-CONSORT psychiatric RCT abstracts were included for analysis. The mean OQS improved from 6.9 (range: 3-13; 95% confidence interval (CI): 6.7-7.2) to 8.2 (range: 4-16; 95% CI: 7.8-8.5) after the CONSORT-A guidelines. Despite improvement, methods of randomization, allocation concealment, and funding source remained to be insufficiently reported (<5%) even after the release of CONSORT-A. High-impact general medical journals, multicenter design, positive outcome, and structured abstracts were associated with better reporting quality.The reporting quality in psychiatric RCT abstracts, although improved, remains suboptimal. To improve reporting quality of psychiatry RCT abstracts, greater efforts by both investigators and journal editors are required to enhance better adherence to the CONSORT-A guidelines.
| S-EPMC5678722 | biostudies-literature
Project description:This study aims to assess the completeness of reporting of randomised controlled trials (RCTs) of acupuncture in the Korean literature.Systematic review.We searched 12 Korean databases and 7 Korean journals to identify eligible RCTs of acupuncture published from 1996 to July 2011. We used the Consolidated Standards of Reporting Trials (CONSORT) checklist for parallel RCTs and the revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) to assess the quality of reporting in Korean RCTs. We compared the completeness of reporting of CONSORT and STRICTA items in RCTs published in two time periods (1996-2004 referred to as the early period and 2005-2011 referred to as the late period).We analysed 146 eligible RCTs using the CONSORT statement concerning RCTs of both needling and non-needling acupuncture and the STRICTA guidelines for 90 trials of needling acupuncture. Among the 103 RCTs in the late period, the proportion of RCTs that completely reported the CONSORT items of outcome definition (15.5%), sample size calculation (2.9%), randomisation (56%), allocation concealment (5.8%), implementation of allocation (11.7%), outcome assessor blinding (20.3%), flow of participants (25.2%), number of participants analysed (19.4%), ancillary analyses (0.0%), adverse events (24.3%), generalisability of findings (1.9%) and overall evidence (32.0%) remained small. Among the 61 RCTs of needling acupuncture in the late period, the STRICTA items of setting/context (24.6%) and practitioner background (27.9%) showed incomplete reporting. The completeness of reporting improved over time in several CONSORT and STRICTA items.The completeness of reporting of Korean RCTs of acupuncture was suboptimal according to the CONSORT and revised STRICTA statements. Trial authors and journal editors should use the CONSORT statement and STRICTA guidelines for transparent reporting in Korean RCTs of acupuncture. The endorsement of the CONSORT and revised STRICTA statements in author instructions is also required.
| S-EPMC4120411 | biostudies-other
Project description:Background:The standards for reporting interventions in clinical trials of cupping (STRICTOC), in the form of a checklist and explanations for users, were designed to improve reporting of cupping trials, particularly the interventions, and thereby facilitating their interpretation and replication. Methods:A group of clinical experts, methodologists, epidemiologists, and editors has developed this STRICTOC checklist through a comprehensive process, including registration of this guideline, literature review, solicitation of comments, consensus meeting, revision, and finalization. Results:The STRICTOC checklist includes 6 items and 16 sub-items, namely cupping rationale, details of cupping, treatment regimen, other components of treatment, treatment provider background, and control or comparator interventions. Illustrative examples of each item are also provided. Conclusions:It is intended that the STRICTOC, in conjunction with both the main Consolidated Standards of Reporting Trials (CONSORT) Statement and extension for nonpharmacologic treatment, will raise the reporting quality of clinical trials of cupping.Trial registration We have registered this study on the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network: http://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials/#STRICTOC.
| S-EPMC6995163 | biostudies-literature