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 ◽  
...  

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.

2011 ◽  
Vol 29 (9) ◽  
pp. 1204-1209 ◽  
Author(s):  
Maud Toulmonde ◽  
Carine Bellera ◽  
Simone Mathoulin-Pelissier ◽  
Marc Debled ◽  
Binh Bui ◽  
...  

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.


2018 ◽  
Vol 5 (1) ◽  
pp. 21
Author(s):  
Mahmood E. Elrggal ◽  
Morooj Al-Muwallad ◽  
Areej Al-Otaibi ◽  
Jomanah Alsiddik ◽  
Alaa Shahbar ◽  
...  

<p class="abstract"><strong>Background:</strong> Randomized controlled trials are often considered as the gold standard for measuring the effectiveness of an intervention. However, inappropriate or poor reporting in randomized controlled trials can produce biased estimates of treatment effects.<strong> </strong>Clinical trials that do not use the CONSORT statement for reporting their findings will have limited value to the clinicians and researchers due to the risk of bias in their results. This review aims to assess the quality of reporting of randomized controlled trials in <em>Helicobacter pylori</em> associated infections by using the CONSORT 2010 checklist.</p><p class="abstract"><strong>Methods:</strong> All issues of 20 highly ranked gastroenterology journals published from Jan 2011 up to November 2017 were searched. Searches were conducted in November 2017. Randomized controlled trials reporting on <em>Helicobacter pylori</em> associated infections were included in the review.</p><p class="abstract"><strong>Results:</strong> 21 randomized controlled trials published in gastroenterology journals were included in the study. All included studies adequately reported (100%) on items including description of interventions, outcomes assessed, total number of participants analysed, baseline characteristics and results of outcome assessed. However, items including blinding and mechanism of allocation concealment were reported in only 12 randomized controlled trials (50%).<strong> </strong>The maximum and minimum scores and percentage of compliance of included randomised controlled trials were 24 (100%) and 15 (62.5%) respectively.</p><p><strong>Conclusions: </strong>The finding of this review suggests that the overall quality of reporting in the included randomized controlled trials was adequate. However, items including trial design, trial registration and protocol and sample size calculations should be reported adequately in the future randomized controlled trials to improve the quality of reporting and replicability of clinical trials.</p>


PLoS ONE ◽  
2021 ◽  
Vol 16 (9) ◽  
pp. e0257093
Author(s):  
Yuhuan Yin ◽  
Fugui Shi ◽  
Yiyin Zhang ◽  
Xiaoli Zhang ◽  
Jianying Ye ◽  
...  

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.


2016 ◽  
Vol 9 ◽  
pp. 135-139 ◽  
Author(s):  
Dimitrios Rikos ◽  
Efthimios Dardiotis ◽  
Georgios Tsivgoulis ◽  
Elias Zintzaras ◽  
Georgios M. Hadjigeorgiou

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Vânia Mozetic ◽  
Letícia Leonel ◽  
Rafael Leite Pacheco ◽  
Carolina de Oliveira Cruz Latorraca ◽  
Taís Guimarães ◽  
...  

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.


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