scholarly journals Protocol for a scoping review of post-trial extensions of randomised controlled trials using individually linked administrative and registry data

BMJ Open ◽  
2017 ◽  
Vol 7 (2) ◽  
pp. e013770 ◽  
Author(s):  
Tiffany Fitzpatrick ◽  
Laure Perrier ◽  
Andrea C Tricco ◽  
Sharon E Straus ◽  
Peter Jüni ◽  
...  
Keyword(s):  
Scoping Review ◽  
Randomised Controlled Trials ◽  
Registry Data ◽  
Controlled Trials ◽  
Post Trial ◽  
Randomised Controlled

scholarly journals Rationalisations for women-only randomised controlled trials in conditions that affect both sexes: a scoping review protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e043370
Author(s):  
Ainsley Matthewson ◽  
Olena Bereznyakova ◽  
Brian Dewar ◽  
Alexandra Davis ◽  
Mark Fedyk ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Scoping Review ◽  
Randomised Controlled Trials ◽  
Standard Of Care ◽  
Standards Of Care ◽  
Controlled Trials ◽  
Theory Approach ◽  
Reference Centre ◽  
Cochrane Database ◽  
Randomised Controlled

IntroductionWomen have historically been under-represented in randomised controlled trials (RCTs), including many landmark RCTs that established standards of care. In light of this fact, some modern researchers are calling for replication of earlier landmark trials with women only. This approach is ethically concerning, in that it would require some enrolled women to be deprived of treatments that are currently considered standard of care.ObjectiveIn an attempt to better understand the justification of a women-only approach to designing clinical trials, this study looks to systematically categorise the number of women-only RCTs for conditions that affect both men and women and the reasons given within the medical and philosophical literatures to perform them.MethodologyThis scoping review of the literature will search, screen and select articles based on predetermined inclusion/exclusion criteria, after which a grounded theory approach will be used to synthesise the data. It is expected that there will be a variety of reasons given for why a women-only trial may be justified. Electronic databases that will be searched include MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Clinical Trials Register, Web of Science Proceedings, ClinicalTrials.gov, Philosopher’s Index, Phil Papers, JSTOR, Periodicals Archive Online, Project MUSE and the National Reference Centre for Bioethics.SignificanceThe scope of this study is to determine published rationales used to justify women-only randomised trials, both in the case of new trials and in the repetition of landmark trials.Ethics and disseminationResearch ethics board approval is not required for this study as there is no participant involvement. Results will be published as a stand-alone manuscript and will inform a larger project related to the ethics of a women-only RCT of carotid intervention for women with symptomatic high-grade carotid stenosis.

scholarly journals Statistical methods for the analysis of adverse event data in randomised controlled trials: a scoping review and taxonomy

2020 ◽  
Author(s):  
Rachel Phillips ◽  
Odile Sauzet ◽  
Victoria Cornelius
Keyword(s):  
Statistical Methods ◽  
Scoping Review ◽  
Randomised Controlled Trials ◽  
Effective Means ◽  
Estimation Methods ◽  
Controlled Trials ◽  
Event Data ◽  
Group Sequential ◽  
Group Sequential Methods ◽  
Randomised Controlled

Abstract BackgroundStatistical methods for the analysis of harm outcomes in randomised controlled trials (RCTs) are rarely used, and there is a reliance on simple approaches to display information such as in frequency tables. We aimed to identify whether any statistical methods had been specifically developed to analyse prespecified secondary harm outcomes and non-specific emerging adverse events (AEs).MethodsA scoping review was undertaken to identify articles that proposed original methods or the original application of existing methods for the analysis of AEs that aimed to detect potential adverse drug reactions (ADRs) in phase II-IV parallel controlled group trials. Methods where harm outcomes were the (co)-primary outcome were excluded.Information was extracted on methodological characteristics such as: whether the method required the event to be prespecified or could be used to screen emerging events; and whether it was applied to individual events or the overall AE profile. Each statistical method was appraised and a taxonomy was developed for classification.ResultsForty-four eligible articles proposing 73 individual methods were included. A taxonomy was developed and articles were categorised as: visual summary methods (8 articles proposing 20 methods); hypothesis testing methods (11 articles proposing 16 methods); estimation methods (15 articles proposing 24 methods); or methods that provide decision-making probabilities (10 articles proposing 13 methods). Methods were further classified according to whether they required a prespecified event (9 articles proposing 12 methods), or could be applied to emerging events (35 articles proposing 61 methods); and if they were (group) sequential methods (10 articles proposing 12 methods) or methods to perform final/one analyses (34 articles proposing 61 methods). ConclusionsThis review highlighted that a broad range of methods exist for AE analysis. Immediate implementation of some of these could lead to improved inference for AE data in RCTs. For example, a well-designed graphic can be an effective means to communicate complex AE data and methods appropriate for counts, time-to-event data and that avoid dichotomising continuous outcomes can improve efficiencies in analysis. Previous research has shown that adoption of such methods in the scientific press is limited and that strategies to support change are needed.

scholarly journals Defining key design elements of registry-based randomised controlled trials: a scoping review

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Bill Karanatsios ◽  
Khic-Houy Prang ◽  
Ebony Verbunt ◽  
Justin M. Yeung ◽  
Margaret Kelaher ◽  
...  
Keyword(s):  
Scoping Review ◽  
Randomised Controlled Trials ◽  
Controlled Trials ◽  
Design Elements ◽  
Randomised Controlled

scholarly journals Hibiscus Tea and Health: A Scoping Review of Scientific Evidence

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Etheridge CJ ◽  
Derbyshire EJ
Keyword(s):  
Oxidative Stress ◽  
Risk Factors ◽  
Systematic Review ◽  
Scoping Review ◽  
Randomised Controlled Trials ◽  
Scientific Evidence ◽  
Controlled Trials ◽  
Hibiscus Sabdariffa ◽  
Pubmed Search ◽  
Randomised Controlled

Over the last few decades, health evidence has been building for hibiscus tea (Hibiscus sabdariffa L. Malvaceae). Previous reviews show promise in relation to reducing cardiovascular risk factors, hypertension and hyperlipidaemia, but broader health perspectives have not been widely considered. Therefore, a scoping review was undertaken to examine the overall health effects of hibiscus tea. A PubMed search was undertaken for metaanalysis (MA) and systematic review papers, human randomised controlled trials (RCT) and laboratory publications investigating inter-relationships between hibiscus tea and health. Twenty-two publications were identified (four systematic/MA papers, nine human RCT controlled trials and nine laboratory publications).Strongest evidence exists in relation to cardiovascular disease, suggesting that drinking 2-3 cups daily (each ≈ 240-250 mL) may improve blood pressure and potentially serve as a preventative or adjunctive therapy against such conditions. Emerging evidence exists for favourable effects on lipid profiles, insulin resistance, oxidative stress and inflammation. Further research using larger and longer human studies is warranted.

scholarly journals Statistical methods for the analysis of adverse event data in randomised controlled trials: a scoping review and taxonomy

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Rachel Phillips ◽  
Odile Sauzet ◽  
Victoria Cornelius
Keyword(s):  
Statistical Methods ◽  
Scoping Review ◽  
Randomised Controlled Trials ◽  
Effective Means ◽  
Estimation Methods ◽  
Controlled Trials ◽  
Event Data ◽  
Group Sequential ◽  
Group Sequential Methods ◽  
Randomised Controlled

Abstract Background Statistical methods for the analysis of harm outcomes in randomised controlled trials (RCTs) are rarely used, and there is a reliance on simple approaches to display information such as in frequency tables. We aimed to identify whether any statistical methods had been specifically developed to analyse prespecified secondary harm outcomes and non-specific emerging adverse events (AEs). Methods A scoping review was undertaken to identify articles that proposed original methods or the original application of existing methods for the analysis of AEs that aimed to detect potential adverse drug reactions (ADRs) in phase II-IV parallel controlled group trials. Methods where harm outcomes were the (co)-primary outcome were excluded. Information was extracted on methodological characteristics such as: whether the method required the event to be prespecified or could be used to screen emerging events; and whether it was applied to individual events or the overall AE profile. Each statistical method was appraised and a taxonomy was developed for classification. Results Forty-four eligible articles proposing 73 individual methods were included. A taxonomy was developed and articles were categorised as: visual summary methods (8 articles proposing 20 methods); hypothesis testing methods (11 articles proposing 16 methods); estimation methods (15 articles proposing 24 methods); or methods that provide decision-making probabilities (10 articles proposing 13 methods). Methods were further classified according to whether they required a prespecified event (9 articles proposing 12 methods), or could be applied to emerging events (35 articles proposing 61 methods); and if they were (group) sequential methods (10 articles proposing 12 methods) or methods to perform final/one analyses (34 articles proposing 61 methods). Conclusions This review highlighted that a broad range of methods exist for AE analysis. Immediate implementation of some of these could lead to improved inference for AE data in RCTs. For example, a well-designed graphic can be an effective means to communicate complex AE data and methods appropriate for counts, time-to-event data and that avoid dichotomising continuous outcomes can improve efficiencies in analysis. Previous research has shown that adoption of such methods in the scientific press is limited and that strategies to support change are needed. Trial registration PROSPERO registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=97442

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