scholarly journals Does a "Level I Evidence" rating imply high quality of reporting in orthopaedic randomised controlled trials?

2006 ◽  
Vol 6 (1) ◽  
Author(s):  
Rudolf W Poolman ◽  
Peter AA Struijs ◽  
Rover Krips ◽  
Inger N Sierevelt ◽  
Kristina H Lutz ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Controlled Trials ◽  
Quality Of Reporting ◽  
High Quality ◽  
Evidence Rating ◽  
Level I ◽  
Randomised Controlled

Improved quality of reporting safety data of medication in paediatric randomised controlled trials

2021 ◽  
pp. archdischild-2020-321197
Author(s):  
Taco Jan Prins ◽  
Corine Rollema ◽  
Eric van Roon ◽  
Tjalling de Vries
Keyword(s):  
Adverse Events ◽  
Randomised Controlled Trials ◽  
Safety Data ◽  
Drug Event ◽  
Controlled Trials ◽  
Quality Of Reporting ◽  
Event Reporting ◽  
The Past ◽  
Randomised Controlled

ObjectiveEvaluating the reporting of safety data of medication in paediatric randomised controlled trials (RCTs) in 2017–2018 compared with our earlier study.DesignLiterature search with a systemic appraisal of adverse drug event reporting.Main outcome measuresQuality of reporting of safety data using Consolidated Standards of Reporting Trials (CONSORT) and Ioannidis scores in paediatric drug RCTs. The CONSORT score consists of nine recommendations of the CONSORT Group issued to improve the quality of reporting adverse events. The Ioannidis score is based on these advices. We considered a CONSORT score of at least 6 and an Ioannidis score of at least 3 as sufficient.ResultsWe reviewed 100 RCTs published in 2017 and 2018. Ninety-four (94%) articles mentioned adverse events compared with 78% in the earlier study. Fifty-seven per cent used a standardised method for reporting adverse events compared with 34% in our earlier study. In 26 of the articles, the expected adverse events were defined, and 27 articles had a preset standardised scale for adverse events. Of these, 62 articles (62%) had a CONSORT score of 6 or higher compared with 18% in 2010. In the present study, 67% had an Ioannidis score of 3 or higher, whereas in the earlier study this was 29%. Both differences are statistically significant (p<0.05).ConclusionsReporting safety data in paediatric RCTs has improved over the past 10 years. However, there is still room for improvement and for further improvement. Authors and editors should give more attention to methods for collecting, reporting and presenting safety data of RCTs in studies and manuscripts.

scholarly journals The quality of reporting of randomised controlled trials in asthma: a systematic review

2013 ◽  
Vol 22 (4) ◽  
pp. 417-424 ◽  
Author(s):  
Chara Ntala ◽  
Panagiota Birmpili ◽  
Allison Worth ◽  
Niall H Anderson ◽  
Aziz Sheikh
Keyword(s):  
Systematic Review ◽  
Randomised Controlled Trials ◽  
Controlled Trials ◽  
Quality Of Reporting ◽  
Randomised Controlled

Assessment of Reporting Quality in Randomised Controlled Trials of Acupuncture for Post-Stroke Rehabilitation Using the Consort Statement and Stricta Guidelines

2017 ◽  
Vol 35 (2) ◽  
pp. 100-106 ◽  
Author(s):  
Jingchun Zeng ◽  
Guohua Lin ◽  
Lixia Li ◽  
Liming Lu ◽  
Chuyun Chen ◽  
...  
Keyword(s):  
Stroke Rehabilitation ◽  
Randomised Controlled Trials ◽  
Reporting Quality ◽  
Consort Statement ◽  
Allocation Concealment ◽  
Controlled Trials ◽  
Quality Of Reporting ◽  
Post Stroke ◽  
Randomised Controlled

Objectives To evaluate the completeness of reporting of randomised controlled trials (RCTs) of acupuncture for post-stroke rehabilitation in order to provide information to facilitate transparent and more complete reporting of acupuncture RCTs in this field. Methods Multiple databases were searched from their inception through September 2015. Quality of reporting for included papers was assessed against a subset of criteria adapted from the Consolidated Standards for Reporting Trials (CONSORT) 2010 statement and the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines. Each item was scored 1 if it was reported, or 0 if it was not clearly stated. Descriptive statistical analysis was performed. Cohen's κ-statistics were calculated to assess agreement between the two reviewers. Results A total of 87 RCTs were included in the full text. Based on CONSORT, good reporting was evident for items “Randomised’ in the title or abstract’, ‘Participants’, ‘Statistical methods’, ‘Recruitment’, ‘Baseline data’, and ‘Outcomes and estimation’, with positive rates >80%. However, the quality of reporting for the items ‘Trial design’, ‘Outcomes’, ‘Sample size’, ‘Allocation concealment’, ‘Implementation’, ‘Blinding’, ‘Flow chart’, ‘Intent-to-treat analysis’, and ‘Ancillary analyses’ was very poor with positive rates <10%. Based on STRICTA, the items ‘Number of needle insertions per subject per session’, ‘Responses sought’, and ‘Needle type’ had poor reporting with positive rates <50%. Substantial agreement was observed for most items and good agreement was observed for some items. Conclusions The reporting quality of RCTs in acupuncture for post-stroke rehabilitation is unsatisfactory and needs improvement.

scholarly journals Inclusion of older patients with cancer in randomised controlled trials with patient-reported outcomes: a systematic review

2019 ◽  
pp. bmjspcare-2019-001902
Author(s):  
Francesco Sparano ◽  
Neil K Aaronson ◽  
Mirjam A G Sprangers ◽  
Peter Fayers ◽  
Andrea Pusic ◽  
...  
Keyword(s):  
Systematic Review ◽  
Older Patients ◽  
Randomised Controlled Trials ◽  
Patient Reported Outcomes ◽  
Controlled Trials ◽  
High Quality ◽  
Quality Of Life Research ◽  
Patient Reported ◽  
Randomised Controlled

ObjectivesInclusion of patient-reported outcomes (PROs) in cancer randomised controlled trials (RCTs) may be particularly important for older patients. The objectives of this systematic review were to quantify the frequency with which older patients are included in RCTs with PROs and to evaluate the quality of PRO reporting in those trials.MethodsAll RCTs with PRO endpoints, published between January 2004 and February 2019, which included a patient sample with a mean/median age ≥70 years, were considered for this systematic review. The following cancer malignancies were considered: breast, colorectal, lung, prostate, gynaecological and bladder cancer.Quality of PRO reporting was evaluated using the International Society for Quality of Life Research–PRO standards. Studies meeting at least two-thirds of these criteria were considered to have high-quality PRO reporting.ResultsOf 649 RCTs identified with a PRO endpoint, only 72 (11.1%) included older patients. Of these, 35 trials (48.6%) were conducted in patients with metastatic/advanced disease. PROs were primary endpoints in 20 RCTs (27.8%). Overall survival was the most frequently reported clinical outcome in studies of patients with metastatic/advanced cancer (n=28, 80%). One-third of the RCTs (n=24, 33.3%) were considered to have high-quality PRO reporting. Overall, the largest prevalence of RCTs with high-quality PRO reporting was observed in prostate and colorectal cancers.ConclusionsOur review indicates not only that PRO–RCT-based studies in oncology rarely include older patients but also that completeness of PRO reporting of many of them is often suboptimal.

scholarly journals Erratum to: Quality of reporting of randomised controlled trials in chiropractic using the CONSORT checklist

2016 ◽  
Vol 24 (1) ◽  
Author(s):  
Fay Karpouzis ◽  
Rod Bonello ◽  
Mario Pribicevic ◽  
Allan Kalamir ◽  
Benjamin T. Brown
Keyword(s):  
Randomised Controlled Trials ◽  
Controlled Trials ◽  
Quality Of Reporting ◽  
Randomised Controlled

Reporting of Randomised Controlled Trials in Hodgkin’s Lymphoma from 1966 to 2002. A Pre- and after CONSORT Evaluation.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 1336-1336
Author(s):  
Thilo Kober ◽  
Sven Trelle ◽  
Alex Greb ◽  
Nicole Skoetz ◽  
Andreas Engert
Keyword(s):  
Adverse Events ◽  
Confidence Interval ◽  
Randomised Controlled Trials ◽  
Hodgkin’S Lymphoma ◽  
Hodgkin's Lymphoma ◽  
Controlled Trials ◽  
Power Calculation ◽  
Quality Of Reporting ◽  
Randomised Controlled

Abstract Introduction/Background: Health professionals base treatment decisions primarily on scientific findings in the medical literature. Randomised controlled trials (RCTs) are considered the best tool to evaluate the applicability of clinical research but there is overwhelming evidence to indicate that the quality of reporting RCTs is less than optimal. The Consolidated Standards for Reporting Trials (CONSORT) statement was developed to help to improve the quality of reports of RCTs and published in 1996. Methods and Material: Retrospective survey of reports of RCTs in Hodgkin’s lymphoma published in English and German between 1966 and 2002. Evaluation tool was a 14-item questionnaire based on the validated CONSORT checklist. Statistical analysis was performed by chi-square method and Fisher’s exact test where appropriate. Results: The analysis of 243 published full-text articles in 59 journals from early 1966 to the end of 2002 indicates an improvement in the quality of reporting RCTs after CONSORT but this enrichment is not consistent. A highly significant enhancement post CONSORT was observed in 5 out of 14 reporting items (i.e. 35.7%; description of statistics methods, reporting of power calculation, ITT analysis, primary outcomes and 95% confidence interval (P=&lt;.0005 – .002)). A sixth reporting item (adverse events) achieved borderline significance (P=.055). Intention-to-treat was explicitly mentioned in 11.9% (29/243), summary results for each comparative group was 98.4% (239/243) and precision of estimated effect size (95% confidence interval) were provided in 21.8% (53/243) respectively. Adverse events were reported in 77% (187/243), and conflict of interest was declared in 4.5% (11/243). Deviations in the reported versus performed randomised allocation in a subset of reports specifically mentioning ITT analysis (n=29) ranged from 2.5%–15%. Conclusions: Despite years of educational efforts, reporting of randomised clinical trials for Hodgkin’s lymphoma in the scientific literature remains unsatisfactory and requires further concerted action by publishers, journal editors, learned societies and medical schools.

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