scholarly journals Quality of patient-reported outcome reporting according to the CONSORT statement in randomized controlled trials with glioblastoma patients

2020 ◽  
Author(s):  
Louis Garnier ◽  
Emilie Charton ◽  
Antoine Falcoz ◽  
Sophie Paget-Bailly ◽  
Dewi Vernerey ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Consort Statement ◽  
Quality Score ◽  
Controlled Trials ◽  
Quality Of Reporting ◽  
Factors Associated ◽  
Randomized Controlled ◽  
Patient Reported ◽  
Consort Pro

Abstract Background Randomized 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. Methods From 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. Results Forty-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. Conclusion Despite the importance of measuring PROs in patients with glioblastoma, employment of the CONSORT-PRO statement is poor in RCTs.

scholarly journals Assessment of quality of reporting of Helicobacter pylori related randomized controlled trials: a focus on highly ranked gastroenterology journals

2018 ◽  
Vol 5 (1) ◽  
pp. 21
Author(s):  
Mahmood E. Elrggal ◽  
Morooj Al-Muwallad ◽  
Areej Al-Otaibi ◽  
Jomanah Alsiddik ◽  
Alaa Shahbar ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Helicobacter Pylori ◽  
Randomized Controlled Trials ◽  
Consort Statement ◽  
Allocation Concealment ◽  
Controlled Trials ◽  
Quality Of Reporting ◽  
Randomized Controlled ◽  
Randomised Controlled

<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>

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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