Mike Clarke's research while affiliated with Queen's University Belfast and other places
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Publications (569)
![Fig 2. SANDWICH logic model. Adapted from Blackwood et al., 2022 [14]....](publication/375984427/figure/fig1/AS:11431281207463000@1701192727251/SANDWICH-logic-model-Adapted-from-Blackwood-et-al-2022-14-COMFORT-is-the-name-of_Q320.jpg)
Background
Prolonged mechanical ventilation increases the risk of mortality and morbidity. Optimising sedation and early testing for possible liberation from invasive mechanical ventilation (IMV) has been shown to reduce time on the ventilator. Alongside a multicentre trial of sedation and ventilation weaning, we conducted a mixed method process ev...
Background
The application of artificial intelligence (AI) in the delivery of health care is a promising area, and guidelines, consensus statements, and standards on AI regarding various topics have been developed.
Objective
We performed this study to assess the quality of guidelines, consensus statements, and standards in the field of AI for medi...
Background Core outcome sets (COS) represent agreed-upon sets of outcomes, which are the minimum that should be measured and reported in all trials in specific health areas. Use of COS can reduce outcome heterogeneity, selective outcome reporting, and research waste, and can facilitate evidence syntheses. Despite benefits of using COS, current use...
Introduction
Angle-closure is responsible for half of all glaucoma blindness globally. Patients with suspected glaucoma require assessment of the drainage angle by an experienced clinician. The goal of this study is to evaluate the diagnostic performance and cost-effectiveness of two non-contact tests, anterior segment OCT (Optical Coherence Tomogr...
Background:
The number of patients completing unsupervised home spirometry has recently increased due to more widely available portable technology and the COVID-19 pandemic, despite a lack of solid evidence to support it. This systematic methodology review and meta-analysis explores quantitative differences in unsupervised spirometry compared with...
Background
The need to engage boys in gender-transformative relationships and sexuality education (RSE) to reduce adolescent pregnancy is endorsed by the World Health Organization and the United Nations Educational, Scientific and Cultural Organization.
Objectives
To evaluate the effects of If I Were Jack on the avoidance of unprotected sex and ot...
Topic:
This review summarizes existing evidence on the impact of vision impairment and ocular morbidity and their treatment on children's quality of life (QoL).
Clinical relevance:
Myopia and strabismus are associated with reduced QoL among children. Surgical treatment of strabismus significantly improves affected children's QoL.
Methods:
We c...
Background: The concept of core outcome sets (COS) has been introduced in China for about 10 years. In recent years, some Chinese researchers also committed to developing COS, though the majority of COS are ongoing. However, there were more than 500 published COS for research in the COMET database by 2020. Whether the disease category of ongoing an...
Objectives:
To determine whether early switch to oral antibiotic treatment in adults with neutropenic sepsis at low risk of complications, is non-inferior to switching later.
Methods:
This non-inferiority, parallel group, randomized, open-label clinical trial enrolled UK adults hospitalized with neutropenic sepsis. Participants were randomly ass...
Background
To evaluate the number of citations for Cochrane Methodology Reviews after they have been updated or co-published in another journal, and the effect of co-publishing the review on the co-publishing journal’s impact factor (IF).
Methods
We identified all Cochrane Methodology Reviews published in the Cochrane Database of Systematic Review...
Context:
Delirium is a serious neurocognitive syndrome which is highly prevalent in people approaching the end of life. Existing trials of interventions to prevent or treat delirium in adults receiving palliative care report heterogeneous outcomes.
Objectives:
To undertake an international consensus process to develop a core outcome set for tria...
Rationale:
Mesenchymal stromal cells (MSCs) may modulate inflammation, promoting repair in COVID-19-related Acute Respiratory Distress Syndrome (ARDS).
Objectives:
We investigated safety and efficacy of ORBCEL-C (CD362-enriched, umbilical cord-derived MSCs) in COVID-related ARDS.
Methods:
This multicentre, randomised, double-blind, allocation...
Background
The prioritisation of updating published systematic reviews of interventions is vital to prevent research waste and ensure relevance to stakeholders. The consideration of health equity in reviews is also important to ensure interventions will not exacerbate the existing inequities of the disadvantaged if universally implemented. This stu...
Poor quality diets represent major risk factors for the global burden of disease. Modeling studies indicate a potential for diet-related fiscal and pricing policies (FPs) to improve health. There is real-world evidence (RWE) that such policies can change behavior; however, the evidence regarding health is less clear. We conducted an umbrella review...
Background To evaluate the number of citations for Cochrane Methodology Reviews after they have been updated or co-published in another journal.
Methods We identified all Cochrane Methodology Reviews published in the Cochrane Database of Systematic Reviews (CDSR) before 2018 and searched for any versions co-published in another journal in the Web o...
Unlabelled:
To gain consensus on measurement methods for outcomes (delirium occurrence, severity, time to resolution, mortality, health-related quality of life [HrQoL], emotional distress including anxiety, depression, acute stress, and post-traumatic stress disorder, and cognition) of our Core Outcome Set (COS) for trials of interventions to prev...
Background:
The choice of outcome measure is a critical decision in the design of any clinical trial, but many Phase III clinical trials in critical care fail to detect a difference between the interventions being compared. This may be because the surrogate outcomes used to show beneficial effects in early phase trials (which informed the design o...
Abstract
Background Over recent decades, improvements in healthcare have reduced mortality and morbidity rates in many
conditions. This has resulted, in part, from the identifcation of efective interventions in randomised trials, and in con�ducting such trials, a composite outcome measure (COM) with multiple components will increase event rates, w...
Context:
Poor diet has been implicated in a range of noncommunicable diseases. Fiscal and pricing policies (FPs) may offer a means by which consumption of food and non-alcoholic beverages with links to such diseases can be influenced to improve public health.
Objective:
To examine the acceptability of FPs to reduce diet-related noncommunicable d...
BACKGROUND
The application of artificial intelligence (AI) in the delivery of health care is a promising area, and guidelines, consensus statements, and standards on AI regarding various topics have been developed.
OBJECTIVE
We performed this study to assess the quality of guidelines, consensus statements, and standards in the field of AI for medi...
An ageing population presents significant nutritional challenges, particularly for partially dentate adults. This two-armed pilot randomised controlled trial (RCT) compared habit formation (automaticity) for healthy eating behaviours between control and intervention groups after participation in a habit-based dietary intervention for older adults,...
Background
Involving men and boys as both users and supporters of Family Planning (FP) is now considered essential for optimising maternal and child health outcomes. Evidence on how to engage men and boys to meet FP needs is therefore important.
Objectives
The main objective of this review was to assess the strength of evidence in the area and unc...
Urban green and blue spaces (UGBS) have the potential to make a significant contribution to the United Nation’s Sustainable Development Goals (SDGs). Research shows the need for UGBS to mitigate the adverse environmental impacts of urbanisation and provide equitable access to resources that reduce social and health inequalities. However, no previou...
Objectives
Individual participant data (IPD) from randomised controlled trials (RCTs) can be used in network meta-analysis (NMA) to underpin patient care and are the best analyses to support the development of guidelines about the use of healthcare interventions for a specific condition. However, barriers to IPD retrieval pose a major threat. The a...
Introduction
Primary cam morphology is highly prevalent in many athlete populations, causing debilitating hip osteoarthritis in some. Existing research is mired in confusion partly because stakeholders have not agreed on key primary cam morphology elements or a prioritised research agenda. We aimed to inform a more rigorous, inclusive and evidence-...
Introduction
Primary cam morphology is a mostly benign bony prominence that develops at the femoral head-neck junction of the hip, but it is highly prevalent in many athlete populations. In the small proportion of athletes for whom it is not benign, the resulting hip osteoarthritis can be debilitating. Clinicians, athletes, patients and researchers...
Well-conducted systematic reviews and other evidence syntheses are important in informing policy and practice decisions. It is reasonable to expect that the processes by which reviews are planned, conducted, analysed and reported are informed by up-to-date research evidence. However, many of the decisions taken when ‘doing’ systematic reviews and o...
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...
Background
The National Institute for Health and Care Excellence recommends macular laser to treat diabetic macular oedema with a central retinal subfield thickness of < 400 µm on optical coherence tomography. The DIAMONDS (DIAbetic Macular Oedema aNd Diode Subthreshold micropulse laser) trial compared standard threshold macular laser with subthres...
Objective
To examine the comparative efficacy and complications of long-acting and intermediate-acting insulin for different patient characteristics for type 1 diabetes mellitus (T1DM).
Design
Systematic review and individual patient data (IPD) network meta-analysis (NMA).
Data sources
MEDLINE, EMBASE and the Cochrane Central Register of Controll...
Individual participant data meta-analyses enable detailed checking of data quality and more complex analyses than standard study-level synthesis of summary data based on publications. However, there is limited existing guidance on the specific systematic checks that should be undertaken to confirm and enhance data quality for individual participant...
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...
Aims
There is no standardised measure of the validity of consent. Over 300 million invasive procedures take place globally each year. This study aims to define a core outcome set (COS) for informed consent for therapy.
Methods
A prospective mixed method study was undertaken in line with a published protocol and the COS was developed in accordance...
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...
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...
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...
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...
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...
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...
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.
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...
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...
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...
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...
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...
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...
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...
Background: Core outcome sets (COS) represent agreed-upon sets of outcomes, which are the minimum that should be measured and reported in all trials in specific health areas. Use of COS can reduce outcome heterogeneity, selective outcome reporting, and research waste, and can facilitate evidence syntheses. Despite benefits of using COS, current use...
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 anticip...
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...
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...
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...
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...
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...
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...
Poor reporting of medical and healthcare systematic reviews is a problem from which the sports and exercise medicine, musculoskeletal rehabilitation, and sports science fields are not immune. Transparent, accurate and comprehensive systematic review reporting helps researchers replicate methods, readers understand what was done and why, and clinici...
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...
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...
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...
Background
Cam morphology, a distinct bony morphology of the hip, is prevalent in many athletes, and a risk factor for hip-related pain and osteoarthritis. Secondary cam morphology, due to existing or previous hip disease (eg, Legg-Calve-Perthes disease), is well-described. Cam morphology not clearly associated with a disease is a challenging conce...
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...
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...
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...
