A comprehensive quality analysis of randomized controlled clinical trials of Asian ginseng and American ginseng based on the CONSORT guideline.
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SUBMITTER: Chen W
PROVIDER: S-EPMC8753457 | biostudies-literature |
REPOSITORIES: biostudies-literature
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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: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: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:BACKGROUND:A considerable amount of randomized controlled trials (RCTs) have been published on statins and/or fibrates for diabetic retinopathy, a clinical condition associated with high social and economic burden. Adherence to the CONSORT statement items is imperative to ensure transparency and reproducibility in clinical research. The aim of this study is to assess the reporting quality and the adherence to CONSORT of RCTs assessing statins and/or fibrates for diabetic retinopathy. METHODS:We conducted a critical appraisal study at Discipline of Evidence-based Medicine, Escola Paulista de Medicina, Universidade Federal de São Paulo (Unifesp). A sensitive literature search was performed to identify all relevant RCTs, with no time or language limits. Two authors independently evaluated the reporting quality of the selected RCTs using the CONSORT statement as a standard. RESULTS:Thirteen reports of RCTs were included in this study. The adherence of the reports to CONSORT items ranged from 24% to 68%. The median score was 11 (interquartile range (IQR) 8 to 13). When analyzed separately, the methods sections of the reports had a median of three items (IQR 2 to 4) judged adherent to the methods items of CONSORT (items 3 to 12). The most underreported items were those related to trial design, title and abstract, allocation concealment, implementation of the randomization sequence, and blinding. Other important items, such as the one related to the description of the inclusion criteria, also had low adherence. CONCLUSIONS:The overall adherence to the CONSORT checklist items was poor, especially in the items related to the methods section. RCT reports on statins and/or fibrates for diabetic retinopathy must be optimized to avoid reporting biases and to improve transparency and reproducibility.
| S-EPMC6916100 | 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 evaluate the reporting quality of randomized controlled trial (RCT) abstracts regarding patients with coronavirus disease 2019 (COVID-19) and to analyze the factors influencing the quality.MethodsThe PubMed, Embase, Web of Science, and Cochrane Library databases were searched to collect RCTs on patients with COVID-19. The retrieval time was from inception to December 1, 2020. The CONSORT statement for abstracts was used to evaluate the reporting quality of RCT abstracts.ResultsA total of 53 RCT abstracts were included. The CONSORT statement for abstracts showed that the average reporting rate of all items was 50.2%. The items with a lower reporting quality were mainly the trial design and the details of randomization and blinding (<10%). The mean overall adherence score across all studies was 8.68 ± 2.69 (range 4-13.5). Multivariate linear regression analysis showed that the higher reporting scores were associated with higher journal impact factor (P < 0.01), international collaboration (P = 0.04), and structured abstract format (P < 0.01).ConclusionsAlthough many RCTs on patients with COVID-19 have been published in different journals, the overall quality of reporting in 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.
| S-EPMC8736283 | biostudies-literature
Project description:BackgroundThe main objectives of this study were to identify the number of randomized controlled trials (RCTs) including a patient-reported outcome (PRO) endpoint across a wide range of cancer specialties and to evaluate the completeness of PRO reporting according to the Consolidated Standards of Reporting Trials (CONSORT) PRO extension.MethodsRCTs with a PRO endpoint that had been performed across several cancer specialties and published between 2004 and 2013 were considered. Studies were evaluated on the basis of previously defined criteria, including the CONSORT PRO extension and the Cochrane Collaboration's tool for assessing the risk of bias of RCTs. Analyses were also conducted by the type of PRO endpoint (primary vs secondary) and by the cancer disease site.ResultsA total of 56,696 potentially eligible records were scrutinized, and 557 RCTs with a PRO evaluation, enrolling 254,677 patients overall, were identified. PROs were most frequently used in RCTs of breast (n = 123), lung (n = 85), and colorectal cancer (n = 66). Overall, PROs were secondary endpoints in 421 RCTs (76%). Four of 6 evaluated CONSORT PRO items were documented in less than 50% of the RCTs. The level of reporting was higher in RCTs with a PRO as a primary endpoint. The presence of a supplementary report was the only statistically significant factor associated with greater completeness of reporting for both RCTs with PROs as primary endpoints (β = .19, P = .001) and RCTs with PROs as secondary endpoints (β = .30, P < .001).ConclusionsImplementation of the CONSORT PRO extension is equally important across all cancer specialties. Its use can also contribute to revealing the robust PRO design of some studies, which might be obscured by poor outcome reporting.
| S-EPMC4755292 | 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:ObjectiveChinese patent medicine (CPM) has been widely used to treat eczema in mainland China for decades. This study aims to investigate circulating CPM for eczema in mainland China and to evaluate the reporting quality of randomized controlled trials (RCTs) of them by using the CONSORT-CHM formulas 2017 (Consolidated Standards of Reporting Trials for Chinese herbal medicine formulas 2017).MethodsCirculating CPM with the indication for eczema was selected by searching three drug databases and confirmed by contacting the manufacturers. RCTs for the treatment of eczema with CPM were selected in four Chinese literature databases and four English literature databases from their inception to August 31, 2019. The reporting quality of included RCTs was assessed based on the CONSORT-CHM formulas 2017. A univariate analysis was conducted to identify the factors associated with the reporting quality.ResultsA total of 70 circulating CPMs had the indication for eczema. Among them, 21 CPMs with 144 RCTs reached the eligible criteria. The mean overall quality score (OQS) of 144 RCTs was 19.85 ± 2.73, which was much less than the maximum score of 38. Of the 38 items, 12 items were reported in over 70% of the trials, 6 items were reported in 50%-70% of the trials, and 16 items were reported in less than 50% of the trials. Publication after 2015 (P < 0.001) and the first author from a university hospital (P=0.010) were associated with the better reporting quality.ConclusionThere are a lot of circulating CPMs with the indication for eczema in mainland China, but both the quantity and the reporting quality of RCTs regarding those CPMs are suboptimal. It is necessary that authors and journal editors learn and adhere to the CONSORT-CHM formulas 2017 to enhance the reporting quality of RCTs for the treatment of eczema with CPM.
| S-EPMC7512083 | biostudies-literature
Project description:Randomized controlled trials (RCTs) of surgical interventions are often more difficult to conduct, and their quality may lag behind other trials.To compare quality domains in trials of surgical interventions, to a previously reported control sample of general medical trials from December 2006.MEDLINE, EMBASE and CENTRAL were searched in May 2009.English language, full text RCTs, performed on humans that compared a surgical intervention to any other intervention.Records were ordered according to their date of publication. The most recently published trials were assessed first, until the required sample of 400 trials was obtained. The search and data collection were piloted by three authors, and was thereafter collected by one author. Data was checked.Although most quality domains were poorly reported, surgical trials compared favourably to general medical trials. Surgical trials were 24% more likely to have an adequate method of random sequence generation, and 71% more likely to have an adequate method of allocation concealment. However, blinding was 40% less likely to be adequate in surgical trials, and sources of funding were 33% less likely to be reported.A single author collected most data. Data was checked and this resulted in few changes.Reporting of most quality domains in surgical intervention trials was better than general medical trials. Blinding was less likely due to the difficulty in conducting sham surgical trials, and reporting of sources of support should improve with adherence to reporting guidelines.
| S-EPMC5936696 | biostudies-other