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.

Seksueel onaangepast gedrag bij een patiënt met dementie: literatuurreview en casusrapport

2021 ◽  
Author(s):  
C. SEAUX ◽  
K. GOEDSEELS ◽  
J. DE LEPELEIRE
Keyword(s):  
Case Studies ◽  
Randomised Controlled Trials ◽  
Selective Serotonin Reuptake Inhibitors ◽  
Controlled Trials ◽  
Pharmacological Treatments ◽  
Pharmacological Interventions ◽  
Drug Of Choice ◽  
Cochrane Database ◽  
History Of ◽  
Randomised Controlled

Sexually inappropriate behaviour in a patient with dementia: literature review and case report In this paper, the medical history of a 75-year-old man with dementia and sexually inappropriate behaviour (SIB) is described. An overview of the literature regarding the approach and treatment of SIB in persons with dementia was performed. PubMed, Web of Science and the Cochrane database were consulted, and thirteen articles selected. There are no randomised controlled trials available. The literature is limited to case studies and reviews of case studies. Non-pharmacological treatments are perceived to be the first step, although they are rarely studied. There is no consensus regarding a pharmacological approach. However, all studies suggest the paradigm of “start low and go slow”. A variety of drugs have been described. When starting a pharmacological treatment, it is recommended to keep in mind comorbidities and possible side-effects. Selective serotonin reuptake inhibitors (SSRIs) seem to be the preferred first line treatment if the behaviour is not too harmful. If the behaviour is intrusive, anti-androgens seem to be the drug of choice. Further research is needed: a consensus regarding the definition and the development of a screening tool could support randomised controlled trials concerning pharmacological and non-pharmacological interventions. Research concerning ethical dilemmas should, however, not be neglected.

scholarly journals Stability of ARDS subphenotypes over time in two randomised controlled trials

Thorax ◽  
2018 ◽  
Vol 73 (5) ◽  
pp. 439-445 ◽  
Author(s):  
Kevin Delucchi ◽  
Katie R Famous ◽  
Lorraine B Ware ◽  
Polly E Parsons ◽  
B Taylor Thompson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Outcomes ◽  
Randomised Controlled Trials ◽  
Latent Class ◽  
Lung Protective Ventilation ◽  
Controlled Trials ◽  
Transition Analysis ◽  
Class 1 ◽  
Randomised Controlled ◽  
Over Time

RationaleTwo distinct acute respiratory distress syndrome (ARDS) subphenotypes have been identified using data obtained at time of enrolment in clinical trials; it remains unknown if these subphenotypes are durable over time.ObjectiveTo determine the stability of ARDS subphenotypes over time.MethodsSecondary analysis of data from two randomised controlled trials in ARDS, the ARMA trial of lung protective ventilation (n=473; patients randomised to low tidal volumes only) and the ALVEOLI trial of low versus high positive end-expiratory pressure (n=549). Latent class analysis (LCA) and latent transition analysis (LTA) were applied to data from day 0 and day 3, independent of clinical outcomes.Measurements and main resultsIn ALVEOLI, LCA indicated strong evidence of two ARDS latent classes at days 0 and 3; in ARMA, evidence of two classes was stronger at day 0 than at day 3. The clinical and biological features of these two classes were similar to those in our prior work and were largely stable over time, though class 2 demonstrated evidence of progressive organ failures by day 3, compared with class 1. In both LCA and LTA models, the majority of patients (>94%) stayed in the same class from day 0 to day 3. Clinical outcomes were statistically significantly worse in class 2 than class 1 and were more strongly associated with day 3 class assignment.ConclusionsARDS subphenotypes are largely stable over the first 3 days of enrolment in two ARDS Network trials, suggesting that subphenotype identification may be feasible in the context of clinical trials.

scholarly journals Interventions for oropharyngeal dysphagia in acute and critical care: a protocol for a systematic review and meta-analysis

2019 ◽  
Vol 8 (1) ◽  
Author(s):  
Sallyanne Duncan ◽  
Jennifer Mc Gaughey ◽  
Richard Fallis ◽  
Daniel F. McAuley ◽  
Margaret Walshe ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Critical Care ◽  
Acute Care ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Oropharyngeal Dysphagia ◽  
Length Of Hospital Stay ◽  
Controlled Trials ◽  
Randomised Controlled

Abstract Background Oropharyngeal dysphagia or swallowing difficulties are common in acute care and critical care, affecting 47% of hospitalised frail elderly, 50% of acute stroke patients and approximately 62% of critically ill patients who have been intubated and mechanically ventilated for prolonged periods. Complications of dysphagia include aspiration leading to chest infection and pneumonia, malnutrition, increased length of hospital stay and re-admission to hospital. To date, most dysphagia interventions in acute care have been tested with acute stroke populations. While intervention studies in critical care have been emerging since 2015, they are limited and so there is much to learn about the type, the delivery and the intensity of treatments in this setting to inform future clinical trials. The aim of this systematic review is to summarise the evidence regarding the relationship between dysphagia interventions and clinically important patient outcomes in acute and critical care settings. Methods We will search MEDLINE, EMBASE, CENTRAL, Web of Science, CINAHL and clinical trial registries from inception to the present. We will include studies conducted with adults in acute care settings such as acute hospital wards or units or intensive care units and critical care settings. Studies will be restricted to randomised controlled trials and quasi-randomised controlled trials comparing a new dysphagia intervention with usual care or another intervention. The main outcomes that will be collected include length of time taken to return to oral intake, change in incidence of aspiration and pneumonia, nutritional status, length of hospital stay and quality of life. Key intervention components such as delivery, intensity, acceptability, fidelity and adverse events associated with such interventions will be collected to inform future clinical trials. Two independent reviewers will assess articles for eligibility, data extraction and quality appraisal. A meta-analysis will be conducted as appropriate. Discussion No systematic review has attempted to summarise the evidence for oropharyngeal dysphagia interventions in acute and critical care. Results of the proposed systematic review will inform practice and the design of future clinical trials. Systematic review registration PROSPERO CRD 42018116849 (http://www.crd.york.ac.uk/PROSPERO/)

50 Tips for Clinical Trialists

2017 ◽  
Vol 19 (1) ◽  
pp. 59-69 ◽  
Author(s):  
Lisa A. Harvey ◽  
Joanne V. Glinsky ◽  
Robert D. Herbert
Keyword(s):  
Clinical Trials ◽  
Randomised Controlled Trials ◽  
Controlled Trials ◽  
Randomised Controlled

This paper presents ‘Tips’ for researchers of brain impairment who are interested in conducting randomised controlled trials. The paper is intended for researchers who are planning to undertake their first trial, but may also be of interest to more experienced trialists or clinicians who want to further their understandings of clinical trials. The Tips include suggestions for how to design, conduct, analyse and report clinical trials.

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 Clinical outcomes and outcome measurement tools reported in randomised controlled trials of treatment for snakebite envenoming: A systematic review

2021 ◽  
Vol 15 (8) ◽  
pp. e0009589
Author(s):  
Michael Abouyannis ◽  
Dinesh Aggarwal ◽  
David G. Lalloo ◽  
Nicholas R. Casewell ◽  
Mainga Hamaluba ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Outcome Measures ◽  
Randomised Controlled Trials ◽  
Core Outcome Set ◽  
Controlled Trials ◽  
Study Protocols ◽  
Outcome Set ◽  
Secondary Analyses ◽  
Randomised Controlled

Background Snakebite is a priority neglected tropical disease and causes a range of complications that vary depending on the snake species. Randomised clinical trials have used varied outcome measures that do not allow results to be compared or combined. In accordance with the Core Outcomes Measurements in Effectiveness Trials (COMET) initiative, this systematic review aims to support the development of a globally relevant core outcome set for snakebite. Methods All randomised controlled trials, secondary analyses of randomised controlled trials and study protocols investigating the efficacy of therapeutics for human snakebite envenoming were eligible for inclusion. Study screening and data extraction were conducted in duplicate by two independent reviewers. All primary and secondary outcome measures were extracted and compiled, as were adverse event outcome measures. Similar outcome measures were grouped into domains. The study was prospectively registered with PROSPERO: CRD42020196160. Results This systematic review included 43 randomised controlled trials, two secondary analyses and 13 study protocols. A total of 382 outcome measures were extracted and, after duplicates were merged, there were 153 unique outcomes. The most frequently used outcome domain (‘venom antigenaemia’) was included in less than one third of the studies. The unique outcomes were classified into 60 outcome domains. Patient-centred outcomes were used in only three of the studies. Discussion Significant heterogeneity in outcome measures exists in snakebite clinical trials. Consensus is needed to select outcome measures that are valid, reliable, patient-centred and feasible. The results of this systematic review strongly support the development of a core outcome set for use in snakebite clinical trials.

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