scholarly journals Reporting quality and adherence of randomized controlled trials about statins and/or fibrates for diabetic retinopathy to the CONSORT checklist

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Vânia Mozetic ◽  
Letícia Leonel ◽  
Rafael Leite Pacheco ◽  
Carolina de Oliveira Cruz Latorraca ◽  
Taís Guimarães ◽  
...  
Keyword(s):  
Diabetic Retinopathy ◽  
Randomized Controlled Trials ◽  
Reporting Quality ◽  
Consort Statement ◽  
Allocation Concealment ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
The Consort Statement ◽  
The One ◽  
Based Medicine

Abstract 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.

scholarly journals Quality Evaluation of Randomized Controlled Trials of Rhodiola Species: A Systematic Review

2021 ◽  
Vol 2021 ◽  
pp. 1-17
Author(s):  
Xiuzhu Li ◽  
Weijie Chen ◽  
Yingqi Xu ◽  
Zuanji Liang ◽  
Hao Hu ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Reporting Quality ◽  
Consort Statement ◽  
Risk Of Bias ◽  
Cochrane Library ◽  
Controlled Trials ◽  
China National Knowledge Infrastructure ◽  
Randomized Controlled ◽  
The Consort Statement ◽  
The Cochrane Library

Background. Rhodiola is a worldwide used medicinal plant for its various medicinal functions, and the number of randomized controlled trials (RCTs) of Rhodiola is increasing in recent years. This study aims to evaluate the reporting quality and risk of bias of the current RCT reports of different Rhodiola species. Methods. Six databases including Embase, PubMed, Web of Science, the Cochrane Library, ClinicalTrial.gov, and China National Knowledge Infrastructure were searched to identify RCTs that used Rhodiola as a single intervention and were published in English or Chinese from inception to December 2020. The Consolidated Standards of Reporting Trials (CONSORT) 2010 statement was used as the checklist for assessment, and a scoring system was applied to the evaluation of RCTs. Score 0 represents no reporting or inadequate reporting, and score 1 represents adequate reporting. The risk of bias of the included studies was also assessed using the Cochrane Risk of Bias tool. Results. A total of 39 RCTs were included in this study, including 23 RCTs of Rhodiola rosea (R. rosea), 8 RCTs of Rhodiola crenulata (R. crenulata), and 8 RCTs of Rhodiola wallichiana (R. wallichiana). None of the included studies met all the CONSORT statement criteria, and the reporting quality of RCTs of the three Rhodiola species was all generally poor. Based on the risk of bias assessment, the majority of included studies were judged to have an unclear risk of bias in most domains due to inadequate reporting. Conclusions. There is inadequate reporting among the included RCTs of different Rhodiola species, and RCTs of Rhodiola with higher reporting quality and better methodological quality are needed.

scholarly journals Evaluation of reporting quality of randomized controlled trials in patients with COVID-19 using the CONSORT statement

PLoS ONE ◽  
2021 ◽  
Vol 16 (9) ◽  
pp. e0257093
Author(s):  
Yuhuan Yin ◽  
Fugui Shi ◽  
Yiyin Zhang ◽  
Xiaoli Zhang ◽  
Jianying Ye ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Reporting Quality ◽  
Consort Statement ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Multivariate Linear Regression Analysis ◽  
Randomized Controlled ◽  
Adherence Score ◽  
The Consort Statement

Objective To evaluate the reporting quality of randomized controlled trials (RCTs) 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 2010 statement was used to evaluate the overall reporting quality of these RCTs. Results 53 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). Conclusion Although 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.

scholarly journals Methodological reporting quality of randomized controlled trials in three leading sports medicine journals over 10 years

2020 ◽  
Author(s):  
Qian Chen ◽  
Qirong Zhou ◽  
Sihua Pan ◽  
Xin Zhi ◽  
Xiaoqun Li ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Sports Medicine ◽  
Reporting Quality ◽  
Consort Statement ◽  
Allocation Concealment ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Scientific Testing

Abstract Background Randomized controlled trials (RCTs) are the gold standard scientific testing for medical interventions. However, low-quality RCTs may provide misleading evidence. This research elucidated the methodological reporting quality of randomized controlled trials (RCTs) in three sports medicine journals over 10 years following the CONSORT statement. Methods and Findings In this study, we evaluated the methodological reporting quality of RCTs in three major sports medicine journals, including Journal of Science and Medicine in Sport, British Journal of Sports Medicine and Clinical Journal of Sports Medicine from 2008 to 2017. The methodological reporting quality, including the allocation sequence generation, allocation concealment, blinding, type of analysis, handling of dropouts were revealed. Number of patients, funding source, type of intervention and country were retrieved. The methodological reporting quality was descriptively reported. A total of 475 trials were involved and 166 (34.9%) trials reported adequate allocation generation, 124 (26.1%) trials reported adequate allocation concealment, 262(55.2%) trials reported adequate blinding, 122 (25.7%) trials reported type of analysis and 100 (21.1%) trials reported handling of dropouts. Conclusions This study shows that the methodological reporting quality of RCTs in the three major sports medicine journals were unsatisfactory and it can be further improved.

Quality of Randomized Controlled Trials Reporting in the Treatment of Sarcomas

2011 ◽  
Vol 29 (9) ◽  
pp. 1204-1209 ◽  
Author(s):  
Maud Toulmonde ◽  
Carine Bellera ◽  
Simone Mathoulin-Pelissier ◽  
Marc Debled ◽  
Binh Bui ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Reporting Quality ◽  
Consort Statement ◽  
Allocation Concealment ◽  
Quality Score ◽  
Controlled Trials ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Oncology Practice

PurposeRandomized controlled trials (RCTs) represent the best evidence in oncology practice. The aim of this study was to assess the reporting quality of sarcoma RCTs and to identify significant predictors of quality.Patients and MethodsTwo investigators searched MEDLINE for pediatric and adult bone and soft tissue sarcoma RCTs published between January 1988 and December 2008. The quality of each report was assessed by using a 15-point overall reporting quality score based on 15 items from the revised Consolidated Standards of Reporting Trials (CONSORT) statement (overall quality score [OQS] range, 0 to 15 points). Concealment of allocation, appropriate blinding, and analysis according to intention-to-treat principle were assessed separately because of their crucial methodologic importance by using a 3-point key methodologic index score (MIS; range, 0 to 3).ResultsWe retrieved 72 relevant RCTs that included 16,029 patients. The median OQS was 9.5. Allocation concealment, blinding, and analysis by intent to treat were reported only in 21 (29%), nine (12.5%), and 23 (32%) of the 72 RCTs, respectively. The median MIS was 1 with a minimum of 0 and a maximum of 2. On multivariate analysis, publication after 1996 and high impact factor remained independent and significant predictors of improved OQS. The sole variable associated with improved MIS was the publication of chemotherapy-only trials.ConclusionAlthough the overall quality of sarcoma RCTs reporting has improved over time, reporting of key methodologic issues remains poor. This may lead to biased interpretation of sarcoma trial results.

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