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Sensitivity analysis will be used to investigate the robustness of the findings. This protocol has been devised using the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2015 checklist.
Formal ethics is not required as primary data will not be collected. The findings of this study will be disseminated through a peer-reviewed publication and conference presentations.
CRD42020190637.
CRD42020190637.
To find effective and safe treatments for COVID-19, the WHO recommended to systemically evaluate experimental therapeutics in collaborative randomised clinical trials. As COVID-19 was spreading in Europe, the French national institute for Health and Medical Research (Inserm) established a transdisciplinary team to develop a multi-arm randomised controlled trial named DisCoVeRy. The objective of the trial is to evaluate the clinical efficacy and safety of different investigational re-purposed therapeutics relative to Standard of Care (SoC) in patients hospitalised with COVID-19.
DisCoVeRy is a phase III, open-label, adaptive, controlled, multicentre clinical trial in which hospitalised patients with COVID-19 in need of oxygen therapy are randomised between five arms (1) a control group managed with SoC and four therapeutic arms with re-purposed antiviral agents (2) remdesivir + SoC, (3) lopinavir/ritonavir + SoC, (4) lopinavir/ritonavir associated with interferon (IFN)-β-1a + SoC and (5) hydroxychloroquine + SoC. The primary endpoint is the clinical status at Day 15 on the 7-point ordinal scale of the WHO Master Protocol (V.3.0, 3 March 2020). This trial involves patients hospitalised in conventional departments or intensive care units both from academic or non-academic hospitals throughout Europe. A sample size of 3100 patients (620 patients per arm) is targeted. This trial has begun on 22 March 2020. Since 5 April 2020, DisCoVeRy has been an add-on trial of the Solidarity consortium of trials conducted by the WHO in Europe and worldwide. On 8 June 2020, 754 patients have been included.
Inserm is the sponsor of DisCoVeRy. click here Ethical approval has been obtained from the institutional review board on 13 March 2020 (20.03.06.51744) and from the French National Agency for Medicines and Health Products (ANSM) on 9 March 2020. Results will be submitted for publication in peer-reviewed journals.
NCT04315948 Eudra-CT 2020-000936-23.
NCT04315948 Eudra-CT 2020-000936-23.
To explore the views of commissioners, service development leads, service managers and senior staff in selected dementia services on increasing the role of primary care in postdiagnostic support for people with dementia.
Qualitative semi-structured telephone interviews and a focus group.
Participants were drawn from National Health Service (NHS) Clinical Commissioning Groups, social care commissioning and a range of dementia services across primary care, secondary mental healthcare, social care and the third sector. All participants were based in England or Wales.
61 professionals, comprising 25 commissioners or service development leads; 25 service managers; and 11 team leads or senior staff.
Participants had varied views on whether a primary care-based approach for postdiagnostic support for people with dementia and their families was appropriate, achievable and/or desirable. Potential benefits of a task-shifted approach were continuity and a more holistic approach to care; familiarity for both patanding and consensus over what postdiagnostic support means in the context of dementia. We will be undertaking such research in the next phase of our programme.
Nicotine replacement therapy (NRT) has proven effective for smoking cessation in clinical trials, however it was found less effective in population-based studies, potentially due to inconsistent or incorrect use of NRT. The aim of this paper is to describe a systematic review protocol to evaluate level of adherence to NRT; the discrepancy of adherence to NRT in clinical and population-based studies and degree of association between level of adherence and success of smoking cessation.
Literature search will use five databases (Medline, Scopus, Embase, CINAHL and PsycINFO). Studies will be appraised for methodological quality using National Institutes of Health Quality Assessment Tool. To reduce heterogeneity, we will analyse clinical trials and population-based studies separately; pooled analyses will be done among studies that used similar measurements. Heterogeneity of studies will be assessed by Higgins' I
statistical test. When studies are adequately homogeneous, results will be pooled using random-effects model with proportion and ORs with 95% CIs and p values for each outcome. We will explain sources of heterogeneity by subgroup analysis or sensitivity analysis. Funnel plots and Egger's regression asymmetry test with p<0.05 will be used as a cut-off point to affirm presence of statistically significant publication bias. Statistical analyses will be carried out using Stata V.16 software. Only studies reporting a valid strategy to control for reverse causality will be included.
This review will provide evidence to support the importance of adherence on rate of smoking cessation and level of adherence to NRT. The findings will be used to inform smoking cessation interventions, researchers and policymakers.
As a systematic literature review, this protocol does not require ethics approval. Research outcomes will be presented at relevant conferences and findings will be published in a relevant peer-reviewed journal.
CRD42020176749.
CRD42020176749.Although cannabis-based products for medicinal use are now legal in the UK, it is still challenging for patients to gain access, and only very few National Health Service prescriptions have been written to date. This paper attempts to make sense of why the UK lags behind so many other countries which also have legalised medical cannabis. From consulting with parents and patients, prescribers, pharmacists and decision-makers it seems that there are a series of distinct barriers to prescribing that need to be overcome in order to improve patient access to medical cannabis in the UK. These include concerns about the perceived lack of scientific evidence. To alleviate these concerns, we highlight the importance of patient-centred approaches including patient-reported outcomes, pharmacoepidemiology and n=1 trials, which can contribute to the development of the evidence base for medical cannabis. We hope that this paper will help policymakers and prescribers understand the challenges to prescribing and so help them develop approaches to overcome the current situation which is detrimental to patients.
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