Characteristics of effective home-based resistance training in patients with noncommunicable chronic diseases: a systematic scoping review of randomised controlled trials

2020 ◽  
pp. 1-12
Author(s):  
Roseanne E Billany ◽  
Noemi Vadaszy ◽  
Courtney J Lightfoot ◽  
Matthew Pm Graham-Brown ◽  
Alice C Smith ◽  
...  
Keyword(s):  
Resistance Training ◽  
Chronic Diseases ◽  
Scoping Review ◽  
Randomised Controlled Trials ◽  
Controlled Trials ◽  
Home Based ◽  
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 Effects of supplementation with carnosine and other histidine-containing dipeptides on chronic disease risk factors and outcomes: protocol for a systematic review of randomised controlled trials

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e020623 ◽  
Author(s):  
Kirthi Menon ◽  
Aya Mousa ◽  
Barbora de Courten
Keyword(s):  
Risk Factors ◽  
Systematic Review ◽  
Chronic Disease ◽  
Chronic Diseases ◽  
Randomised Controlled Trials ◽  
Disease Risk ◽  
Primary Data ◽  
Controlled Trials ◽  
Chronic Disease Risk ◽  
Randomised Controlled

IntroductionAgeing of populations globally, coupled with the obesity epidemic, has resulted in the rising prevalence of chronic diseases including diabetes, cardiovascular diseases, cancers and neurodegenerative disorders. Prevention of risk factors that contribute to these diseases is key in managing the global burden of chronic diseases. Recent studies suggest that carnosine, a dipeptide with anti-inflammatory, antioxidative and antiglycating properties may have a role in the prevention of chronic diseases; however, no previous reviews have examined the effects of carnosine and other histidine-containing peptides (HCDs) on chronic disease risk factors and outcomes. We aim to conduct a comprehensive systematic review to examine the effects of supplementation with carnosine and other HCDs on chronic disease risk factors and outcomes and to identify relevant knowledge gaps.Methods and analysisElectronic databases including Medline, Cumulative Index of Nursing and Allied Health, Embase and all Evidence-Based Medicine will be systematically searched to identify randomised controlled trials (RCTs) and systematic reviews of RCTs, comparing supplementation with carnosine and/or other HCDs versus placebo, usual care or other pharmacological or non-pharmacological interventions. One reviewer will screen titles and abstracts for eligibility according to prespecified inclusion criteria, after which two independent reviewers will perform data extraction and quality appraisal. Meta-analyses, metaregression and subgroup analyses will be conducted where appropriate.Ethics and disseminationEthics approval is not required as this review does not involve primary data collection. This review will generate level-one evidence regarding the effects of carnosine supplementation on chronic disease risk factors and outcomes and will be disseminated through peer-reviewed publications and at conference meetings to inform future research on the efficacy of carnosine supplementation for the prevention of chronic diseases.PROSPERO registration numberCRD42017075354.

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
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