Mike Clarke's research while affiliated with Royal Victoria Regional Health Centre and other places

Publications (526)

Article
Background At the 2015 REWARD/EQUATOR conference on research waste, the late Doug Altman revealed that his only regret about his 1994 BMJ paper ‘The scandal of poor medical research’ was that he used the word ‘poor’ rather than ‘bad’. But how much research is bad? And what would improve things? Main text We focus on randomised trials and look at s...
Article
Natural environments, such as parks, woodlands and lakes, have positive impacts on health and wellbeing. Urban Green and Blue Spaces (UGBS), and the activities that take place in them, can significantly influence the health outcomes of all communities, and reduce health inequalities. Improving access and quality of UGBS needs understanding of the r...
Article
Full-text available
Background 300 million operations and procedures are performed annually across the world, all of which require a patient’s informed consent. No standardised measure of the consent process exists in current clinical practice. We aimed to define a core outcome set for informed consent for therapy. Methods The core outcome set was developed in accord...
Article
Purpose Determine clinical-effectiveness, safety, and cost-effectiveness of subthreshold micropulse laser (SML), compared with standard laser (SL), for diabetic macular edema (DME) with central retinal thickness (CRT) <400μ. Design Pragmatic, multicenter, allocation-concealed, double-masked, randomized, non-inferiority trial. Participants Adults...
Article
Full-text available
Background The need to engage boys in gender-transformative relationships and sexuality education (RSE) to reduce adolescent pregnancy is endorsed by WHO. We aimed to test an intervention which used a gender-transformative approach to engage adolescents in RSE to prevent unprotected sex. Methods This cluster-randomised trial with process and econo...
Article
Objective: To review evidence about the uptake of core outcome sets (COS). A COS is an agreed standardized set of outcomes that should be measured and reported, as a minimum, in all clinical trials in a specific area of health or health care. Study design and setting: This article provides an analysis of what is known about the uptake of COS in...
Article
Introduction: A core outcome set (COS) is a minimal list of consensus outcomes that should be used in all intervention research in a specific domain. COS enhance the ability to undertake meaningful comparisons and to understand the benefits or harms of different treatments. A first step in developing a COS is to identify outcomes that have been use...
Article
Full-text available
Background: Telecare is a health service that involves the home installation of a number of information technology support systems for individuals with complex needs, such as people with reduced mobility or disabilities and the elderly. It involves the use of sensors in patients' homes to detect events, such as smoke in the kitchen, a front door le...
Article
Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows:. To compare the effects of antimicrobial sutures versus standard sutures for the prevention of SSI. Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Article
Full-text available
Objectives To determine the feasibility, implementation and outcomes of an Anticipatory Care Planning (ACP) intervention in primary care to assist older adults at risk of functional decline by developing a personalized support plan. Design Feasibility cluster randomized control trial. Setting and participants Eight primary care practices (four in...
Article
Background: Cochrane systematic reviews (CSRs) have a section ‘Implications for research’ where authors make suggestions for improving future research. The authors of the present study assessed the prevalence and time dynamics of different recommendations in the CSRs about anesthesia and pain. Methods: The authors included all CSRs published by the...
Article
Full-text available
Background Mesenchymal stromal cells (MSCs) may be of benefit in ARDS due to immunomodulatory and reparative properties. This trial investigates a novel CD362 enriched umbilical cord derived MSC product (REALIST ORBCEL-C), produced to Good Manufacturing Practice standards, in patients with moderate to severe ARDS due to COVID-19 and ARDS due to oth...
Article
Topic This systematic review and meta-analysis summarizes existing evidence to establish whether vision impairment, ocular morbidity and their treatment are associated with depression and anxiety in children. Clinical Relevance Understanding and quantifying these associations support early detection and management of mental health symptoms in chil...
Article
Objective To evaluate the impact of co-publication on the citation of Cochrane evidence. Study Design and Setting This was a retrospective cohort study including Cochrane reviews published up to 31 December 2015 and their citing up to 11 July 2021, identified from the Web of Science Core Collection database. Results A total of 101 co-published an...
Article
Full-text available
Objective: To examine the comparative efficacy and safety of cognitive enhancers by patient characteristics for managing Alzheimer's dementia (AD). Design: Systematic review and individual patient data (IPD) network meta-analysis (NMA) based on our previously published systematic review and aggregate data NMA. Data sources: MEDLINE, Embase, Co...
Article
Full-text available
Objectives To assess the impact on readers’ interpretation of the results reported in an abstract for a hypothetical clinical trial with (1) a statistically significant result (SSR), (2) spin, (3) both an SSR and spin compared with (4) no spin and no SSR. Participants Health students and professionals from universities and health institutions in F...
Article
Full-text available
Background: Daily assessment of patient readiness for liberation from invasive mechanical ventilation can reduce the duration of ventilation. However, there is uncertainty about the effectiveness of this in a paediatric population. Objectives: To determine the effect of a ventilation liberation intervention in critically ill children who are ant...
Article
Background: There is uncertainty about the effects of modifications to trial patient invitation letters on recruitment and retention. However, such documents are important. Methods: A 2x2 factorial design embedded a pair of randomised Studies Within a Trial (SWAT) within a large host trial (CLEAR), to evaluate the effects of including wet-ink signa...
Article
Objective To explore the transparency of reporting primary outcome data within randomised controlled trials (RCTs) in the presence of missing data. Study Design / Setting: A cohort examination of RCTs published in the four major medical journals (NEJM, JAMA, BMJ, Lancet) in 2013 and the first quarter of 2018. Data was extracted on reporting qualit...
Article
Full-text available
Introduction: The purpose of this study is to conduct an overview of Cochrane systematic reviews (SRs) evaluating the effects of maternal positions in childbirth in order to compile existing evidence for relevant research questions that have been addressed by more than one review, to provide a succinct summary of the up-to-date evidence and to ide...
Preprint
Full-text available
Background At the 2015 REWARD/EQUATOR conference on research waste, the late Doug Altman revealed that his only regret about his 1994 BMJ paper ‘The scandal of poor medical research’ was that he used the word ‘poor’ rather than ‘bad’. But how much research is bad? And what would improve things? Main text We focus on randomised trials and look at sc...
Article
Full-text available
Background People with severe mental illness (SMI) are less physically active and more sedentary than healthy controls, contributing to poorer physical health outcomes in this population. There is a need to understand the feasibility and acceptability, and explore the effective components, of health behaviour change interventions targeting physical...
Article
Full-text available
Background Mesenchymal stromal cells (MSCs) may be of benefit in acute respiratory distress syndrome (ARDS) due to immunomodulatory, reparative, and antimicrobial actions. ORBCEL-C is a population of CD362 enriched umbilical cord-derived MSCs. The REALIST phase 1 trial investigated the safety and feasibility of ORBCEL-C in patients with moderate to...
Article
Full-text available
Background: Recently, Coronavirus Disease 2019 (COVID-19), caused by severe acute respiratory syndrome virus 2 (SARS-CoV-2), has affected more than 200 countries and lead to enormous losses. This study systematically reviews the application of Artificial Intelligence (AI) techniques in COVID-19, especially for diagnosis, estimation of epidemic tren...
Article
Full-text available
Importance There is limited evidence on the optimal strategy for liberating infants and children from invasive mechanical ventilation in the pediatric intensive care unit. Objective To determine if a sedation and ventilator liberation protocol intervention reduces the duration of invasive mechanical ventilation in infants and children anticipated...
Article
Full-text available
Background Road traffic injuries are a major public health concern and their prevention requires concerted efforts. We aimed to systematically analyse the current evidence to establish whether any aspects of vision, and particularly interventions to improve vision function, are associated with traffic safety outcomes in low-income and middle-income...
Article
The public and patients can be powerful sensors for shaping and powering healthcare research. They are joining research teams as investigators and collaborators to co-produce evidence for the practical use of interventions in clinical practice. While clinicians and researchers are encouraged by funders and policymakers to involve the public and pat...
Article
Objectives: To assess the reporting quality of abstracts for published randomized controlled trials (RCTs) of interventions for coronavirus disease 2019 (COVID-19), including the use of spin strategies and the level of spin for RCTs with statistically non-significant primary outcomes, and to explore potential predictors for reporting quality and t...
Article
Full-text available
Background Trials of interventions to prevent or treat delirium in adults in an acute hospital setting report heterogeneous outcomes. Our objective was to develop international consensus among key stakeholders for a core outcome set (COS) for future trials of interventions to prevent and/or treat delirium in adults with an acute care hospital admis...
Article
Full-text available
Background: There is growing recognition of the need for interventions that effectively involve men and boys to promote family planning behaviours. Evidence suggests that the most effective behavioural interventions in this field are founded on theoretical principles of behaviour change and gender equality. However, there are few evidence synthese...
Article
Full-text available
Background: Rates of adolescent HIV and unintended pregnancy in southern Africa are amongst the highest in the world. Gender-transformative interventions that address underlying gender inequalities and engage both males and females have been emphasised by the World Health Organisation, amongst others, to target prevention. However, few such gender-...
Chapter
This chapter overviews those elements of an individual participant data (IPD) meta-analysis project that differ from a conventional meta-analysis of aggregate data. It describes the advantages and challenges of the IPD approach. IPD meta-analysis projects follow many of the same principles and research processes as conventional systematic reviews a...
Article
Background: Air travel might increase the risk of deep vein thrombosis (DVT). It has been suggested that wearing compression stockings might reduce this risk. This is an update of the review first published in 2006. Objectives: To assess the effects of wearing compression stockings versus not wearing them for preventing DVT in people travelling...
Article
Objectives: Delirium in critically ill adults is highly prevalent and has multiple negative consequences. To-date, trials of interventions to prevent or treat delirium report heterogenous outcomes. To develop international consensus among key stakeholders for a core outcome set for future trials of interventions to prevent and/or treat delirium in...
Article
Full-text available
Aims To provide public health‐related research evidence on types and usage patterns of new psychoactive substances (NPS), developmental pathways into NPS and decision‐making factors for, and associated harms of, NPS use. Design Three‐phase mixed‐methods design, including a latent class analysis (LCA) of the longitudinal Belfast Youth Development S...
Article
Full-text available
Objectives The primary objective of the study is to assess the safety of a single intravenous infusion of Mesenchymal Stromal Cells (MSCs) in patients with Acute Respiratory Distress Syndrome (ARDS) due to COVID-19. Secondary objectives are to determine the effects of MSCs on important clinical outcomes, as described below. Trial design REALIST CO...
Article
Full-text available
Background Advance Care Planning is recommended for people with end-stage kidney disease but evidence is limited. Robust clinical trials are needed to investigate the impact of advance care planning in this population. There is little available data on cost-effectiveness to guide decision makers in allocating resources for advance care planning. Th...
Article
Full-text available
Background: There is considerable actual and potential waste in research. The aim of this paper is to describe how using an Evidence-Based Research approach before conducting a study helps to ensure that the new study truly adds value. Study design and setting: Evidence-Based Research is the use of prior research in a systematic and transparent...
Article
Full-text available
Objective: The aim of our review was to bring together studies that had assessed the uptake of core outcome sets (COS) to explore the level of uptake across different COS and areas of health. Study design and setting: We examined the citations of 337 COS reports to identify studies that had assessed the uptake of a particular COS in randomised c...
Article
Background: There is considerable actual and potential waste in research. Using evidence-based research can ensure the value of a new study. The aim of this paper, the third in a series, is to describe an evidence-based research (EBR) approach to putting research results into context. Study design and setting: Evidence-Based Research is the use...
Article
Full-text available
Objectives: A core outcome set (COS) is an agreed standardised minimum collection of outcomes that should be measured and reported in research in a specific area of health. Cochrane systematic reviews ('reviews') are rigorous reviews on health-related topics conducted under the auspices of Cochrane. This study examines the use of existing COS to i...
Article
Full-text available
Background: Older adults suffering partial tooth loss may need additional intervention strategies other than natural tooth replacement alone to improve their nutritional status. This study aimed to design and develop a habit-based tailored dietary intervention and to assess the feasibility and acceptability of the intervention, in conjunction with...
Article
Full-text available
Background: The World Health Organization declared on March 11, 2020, that the spread of the severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) has escalated from epidemic into pandemic. As the initial outbreak area, China has taken multiple active measures to deal with the epidemic. Updated versions of diagnosis and treatment guideline...
Article
Background: Telecare is a health service that involves the home installation of a number of information technology support systems for individuals with complex needs, such as people with reduced mobility or disabilities and the elderly. It involves the use of sensors in patients' homes to detect events, such as smoke in the kitchen, a front door l...
Preprint
Full-text available
Background: Road traffic injuries are a major public health concern. The burden and road traffic fatality rate are especially high in low-and middle-income countries and the socioeconomic impact is profound. Although many authors have studied the correlation between vision and traffic safety, there is no robust evidence base that could be used in a...
Article
Full-text available
Background: Many randomised trials have serious methodological flaws that fatally undermine their results, which makes the research wasteful. This is of concern for many, including those doing systematic reviews that include trials. Cochrane systematic reviews have a section called ‘ Implications for research ’, which allows authors of the review t...
Article
Full-text available
Background: Major infectious disease outbreaks are a constant threat to human health. Clinical research responses to outbreaks generate evidence to improve outcomes and outbreak control. Experiences from previous epidemics have identified multiple challenges to undertaking timely clinical research responses. This scoping review is a systematic app...
Article
Full-text available
Background As the population of older adults’ increases, the complexity of care required to support those who choose to remain in the community has also increased. Anticipatory Care Planning (ACP) through earlier identification of healthcare needs is evidenced to improve quality of life, decrease the number of aggressive futile interventions, and e...
Article
Clinical research is necessary for an effective response to an emerging infectious disease outbreak. However, research efforts are often hastily organised and done using various research tools, with the result that pooling data across studies is challenging. In response to the needs of the rapidly evolving COVID-19 outbreak, the Clinical Characteri...
Preprint
Full-text available
Background: The World Health Organization declared on 11 March 2020 that the spread of the severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) has escalated from epidemic into pandemic. As the initial outbreak area, China has taken multiple active measures to deal with the epidemic. Updated versions of diagnosis and treatment guideline for...
Preprint
Full-text available
Background: The World Health Organization declared on 11 March 2020 that thespread of the severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) had escalated from epidemic into pandemic. As the initial outbreak area, China has taken multiple active measures to deal with the epidemic. Updated versions of diagnosis and treatment guideline for...
Article
Full-text available
Background: Neutropenic sepsis remains a common treatment complication for patients receiving systemic anti-cancer treatment. The UK National Institute for Health and Care Excellence have not recommended switching from empirical intravenous antibiotics to oral antibiotics within 48 h for patients assessed as low risk for septic complications becau...
Article
Full-text available
Background: Shifts in data sharing policy have increased researchers' access to individual participant data (IPD) from clinical studies. Simultaneously the number of IPD meta-analyses (IPDMAs) is increasing. However, rates of data retrieval have not improved. Our goal was to describe the challenges of retrieving IPD for an IPDMA and provide practi...
Conference Paper
Full-text available
Background As the population of older adults’ increases, the complexity of care required to support those who choose to remain in the community has also increased. Anticipatory Care Planning (ACP) through earlier identification of healthcare needs is evidenced to improve quality of life, decrease the number of aggressive futile interventions, and e...
Preprint
Full-text available
Background: Older adults suffering partial tooth loss may need additional intervention strategies other than natural tooth replacement alone to improve their nutritional status. This study aimed to design and develop a habit-based tailored dietary intervention and to assess the feasibility and acceptability of the intervention, in conjunction with...
Preprint
Full-text available
Background Older adults suffering partial tooth loss may need additional intervention strategies other than oral rehabilitation alone to improve their nutritional status. This study aimed to design and develop a habit-based tailored dietary intervention and to assess the feasibility and acceptability of the intervention, in conjunction with oral re...
Preprint
Full-text available
Background: Older adults suffering partial tooth loss may need additional intervention strategies other than natural tooth replacement alone to improve their nutritional status. This study aimed to design and develop a habit-based tailored dietary intervention and to assess the feasibility and acceptability of the intervention, in conjunction with...
Article
Full-text available
Background: A new type of coronavirus, novel coronavirus (COVID-19), is causing an increasing number of cases of pneumonia and was declared a Public Health Emergency of International Concern by the World Health Organization on 30 January 2020. The virus first appeared in Wuhan, China, in late December 2019, and traditional Chinese herbal medicine...
Article
Background: Many randomised trials have serious methodological flaws that fatally undermine their results, which makes the research wasteful. This is of concern for many, including those doing systematic reviews that include trials. Cochrane systematic reviews all have a section called ‘ Implications for research ’, which allows authors of the revi...