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Publications (372)
Cardiac rehabilitation remains the 'Cinderella' of treatments for heart failure. This state-of-the-art review provides a contemporary update on the evidence base, clinical guidance, and status of cardiac rehabilitation delivery for patients with heart failure. Given that cardiac rehabilitation participation results in important improvements in pati...
Evidence suggests that digitally delivered cardiac rehabilitation (CR) is likely to be an effective alternative to centre-based CR. However, there is limited understanding of the behaviour change techniques (BCTs) and intervention characteristics included in digital CR programmes. This systematic review aimed to identify the BCTs and intervention c...
Rehabilitation Enablement in CHronic Heart Failure (REACH-HF) is a home-based cardiac rehabilitation intervention designed for patients with heart failure and their caregivers. We present a pooled analysis of patients > 18 years with a confirmed diagnosis of HF recruited to two REACH-HF randomised controlled trials. Where identified by patients and...
Ageing populations and improved survival, have contributed to a rise in the number of people living with multimorbidity, raising issues related to polypharmacy, treatment burden, competing priorities and poor coordination of care. Self-management programs are increasingly included as an essential component of interventions to improve outcomes in th...
Objectives:
To quantify the impact of a home-based cardiac rehabilitation intervention (Rehabilitation Enablement in Chronic Heart Failure (REACH-HF)) on objectively assessed physical activity (PA) of patients with heart failure (HF) and explore the extent by which patient characteristics are associated with a change in PA.
Design:
Secondary ana...
Aims:
Coronary heart disease is the most common reason for referral to exercise-based cardiac rehabilitation (CR) globally. However, the generalizability of previous meta-analyses of randomized controlled trials (RCTs) is questioned. Therefore, a contemporary updated meta-analysis was undertaken.
Methods and results:
Database and trial registry...
Purpose:
Given that previous reviews on exercise training in pulmonary hypertension (PH) were largely based on a small number of randomized controlled trials (RCT), their conclusions are subject to bias. This review sought to identify the impact of exercise training on functional capacity and health-related quality of life (HRQoL) in PH using adva...
Aims
Alternative models of cardiac rehabilitation (CR) are required to improve CR access and uptake. Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) is a comprehensive home-based rehabilitation and self-management programme, facilitated by trained health professionals, for people with heart failure (HF) and their caregivers. REACH-HF...
Aims. The CopenHeartVR trial found positive effects of cardiac rehabilitation (CR) on physical capacity at 4 months. The long-term effects of CR following valve surgery remains unclear, especially regarding readmission and mortality. Using data from he CopenHeartVR Trial we investigated long-term effects on physical capacity, mental and physical he...
Using a surrogate endpoint as a substitute for a patient-relevant final outcome enables randomised controlled trials (RCTs) to be conducted more efficiently. However, the use of surrogates remains controversial and there is currently no guideline for the reporting of RCTs using surrogate endpoints; therefore, we seek to develop SPIRIT (Standard Pro...
Background
There is a global underutilisation of cardiac rehabilitation in heart failure. Offering alternative modes of delivery, such as home-based programmes, can lead to an increase in uptake. However, adopting this new mode of delivery may be challenging for service providers who predominantly offer centre-based programmes.
Aim
The study aimed...
Background
Despite robust evidence and national guidance recommending cardiac rehabilitation (CR) for heart failure (HF), access remains poor, a situation magnified by COVID-19. The Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) randomised controlled trial demonstrated the clinical and cost-effectiveness of a novel home-based CR self...
Background
Coronary heart disease (CHD) is the most common reason for referral to exercise-based cardiac rehabilitation (CR) globally. However, the generalisability of previous meta-analyses of randomised controlled trials (RCTs) is questioned.
Aim
To undertake a contemporary, updated Cochrane systematic review and meta-analysis of exercise-based...
Background: Intrusive mental imagery is associated with anxiety and mood instability within bipolar disorder and therefore represents a novel treatment target. Imagery Based Emotion Regulation (IBER) is a brief structured psychological intervention developed to enable people to use the skills required to regulate the emotional impact of these image...
Background:
Screening trials before full implantation of a spinal cord stimulation device are recommended by clinical guidelines and regulators, although there is limited evidence for their use. The TRIAL-STIM study showed that a screening trial strategy does not provide superior patient pain outcome at 6-month follow-up compared with not doing a...
Introduction:
Using a surrogate endpoint as a substitute for a primary patient-relevant outcome enables randomised controlled trials (RCTs) to be conducted more efficiently, that is, with shorter time, smaller sample size and lower cost. However, there is currently no consensus-driven guideline for the reporting of RCTs using a surrogate endpoint...
Introduction Randomised controlled trials (RCTs) may use surrogate endpoints as substitutes and predictors of patient-relevant/participant-relevant final outcomes
(eg, survival, health-related quality of life). Translation of effects measured on a surrogate endpoint into health benefits for patients/participants is dependent on the validity of the...
Background:
The e-coachER trial aimed to determine whether adding web-based behavioural support to exercise referral schemes (ERS) increased long-term device-measured physical activity (PA) for patients with chronic conditions, compared to ERS alone, within a randomised controlled trial. This study explores the mechanisms of action of the e-coachE...
Coronary artery disease (CAD) is one of the leading causes of mortality and morbidity. Exercise-based cardiac rehabilitation (EBCR) has been shown to improve clinical outcomes in these patients, and yet clinicians are often challenged to prescribe the most effective type of exercise training. Therefore, this systematic review and network meta-analy...
BACKGROUND
Different waveforms of spinal cord stimulation (SCS) have now been evaluated for the management of painful diabetic neuropathy (PDN). However, no direct or indirect comparison between SCS waveforms has been performed to date.
PURPOSE
To conduct a systematic review and network meta-analysis to evaluate the effectiveness of SCS for PDN....
Evidence to inform regulatory, funding and clinical decisions about health interventions should come from well-conducted clinical trials. Despite the challenges associated to their design, conduct and generalizability, randomized controlled trials (RCTs) are typically considered the studies providing the least biased estimates of treatment effects...
Screening trials of spinal cord stimulation (SCS) prior to full implantation of a device are recommended by expert guidelines and international regulators. The current study sought to estimate the budget impact of a screening trial of SCS and the costs or savings of discontinuing the use of a screening trial. A budget impact analysis was performed...
Aims
The role of cardiopulmonary exercise testing (CPET) in predicting major adverse cardiovascular events (MACE) in people with congenital heart disease (ConHD) is unknown. A systematic review with meta-analysis was conducted to report the associations between CPET parameters and MACE in people with ConHD.
Methods and results
Electronic databases...
Background
Many male prisoners have significant mental health problems, including anxiety and depression. High proportions struggle with homelessness and substance misuse.
Aims
This study aims to evaluate whether the Engager intervention improves mental health outcomes following release.
Method
The design is a parallel randomised superiority tria...
Background
Guidelines recommend measuring blood pressure (BP) in both arms, adopting the higher arm readings for diagnosis and management. Data to support this recommendation are lacking. We evaluated associations of higher and lower arm systolic BPs with diagnostic and treatment thresholds, and prognosis in hypertension, using data from the Inter-...
Objectives
Patients who suffer from long-term, neuropathic pain that proves refractory to conventional medical management are high consumers of health care resources and experience poorer physical and mental health than people with other forms of pain. Pharmacologic treatments have adverse effects; nonpharmacologic interventions have limitations. S...
The desire, by patients and society, for faster access to therapies has driven a long tradition of the use of surrogate endpoints in the evaluation of pharmaceuticals and, more recently, biologics and other innovative medical technologies. The consequent need for statistical validation of potential surrogate outcome measures is a prime example on t...
Objectives
This study aimed to identify barriers to, and facilitators of, implementation of the Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) programme within existing cardiac rehabilitation services, and develop and refine the REACH-HF Service Delivery Guide (an implementation guide cocreated with healthcare professionals). REACH-H...
Aim
The benefits of cardiac rehabilitation (CR) after acute coronary syndrome (ACS) are well established. However, the relative benefit of CR in those with comorbidities, including diabetes, is not well understood. This systematic review and meta-analysis examined the benefit of CR on exercise capacity and secondary outcomes in ACS patients with a...
Introduction
Despite evidence that cardiac rehabilitation (CR) and self-care are essential in managing heart failure, and strong national and international guidelines recommending their provision, referral and uptake remains low. Centre-based provision is a known barrier, and the need for flexible models of CR has become more pronounced in the rece...
In the drive toward faster patient access to treatments, health technology assessment (HTA) agencies and payers are increasingly faced with reliance on evidence based on surrogate endpoints, increasing decision uncertainty. Despite the development of a small number of evaluation frameworks, there remains no consensus on the detailed methodology for...
Aim
To achieve effectiveness and reduce inequality in everyday cardiac rehabilitation, this study aims to compare individual patient characteristics along with completion rates to traditional and evolving modes of delivery in cardiac rehabilitation.
Method
Patients were included from the UK National Audit of Cardiac Rehabilitation (NACR) database....
Objectives
Pain score, functional disability, and health-related quality of life (HRQoL) are core outcome domains for chronic pain clinical trials. Although greater levels of pain reduction have been shown to be linked to larger gains in HRQoL, little is known of the association between HRQoL and disability in the setting of chronic pain. The aims...
Background
Atrial Fibrillation (AF) increases thromboembolism and stroke risk; this can be reduced by oral anticoagulation, but only if AF is detected. A portable, point-of-care device, capable of accurately detecting and identifying AF could reduce workload and diagnostic delay by minimising need for follow-up 12-lead electrocardiogram (ECGs).
Ob...
Objectives
Spinal cord stimulation (SCS) is a recognized intervention for the management of chronic neuropathic pain. The United Kingdom National Institute of Health and Care Excellence has recommended SCS as a management option for chronic neuropathic pain since 2008. The aim of this study is to undertake an assessment of SCS uptake across the Nat...
Background
People in prison experience a range of physical and mental health problems. Evaluating the effectiveness and efficiency of prison-based interventions presents a number of methodological challenges. We present a case study of an economic evaluation of a prison-based intervention (“Engager”) to address common mental health problems.
Metho...
Objectives
SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) statements have been shown to improve the quality of reporting of trial protocols and randomized controlled trials. Extensions to the SPIRIT and CONSORT statements specific to certain interventions have the...
Aims
To develop a model to evaluate the cost-effectiveness of 4 mg dibotermin alfa/absorbable collagen sponge (ACS) versus iliac crest bone graft (ICBG) in patients with lumbar degenerative disc disease in the United Kingdom.
Materials & Methods
A Markov decision-analytic model was constructed to calculate costs and quality-adjusted life-years ove...
Objective
This randomised controlled trial (RCT) aimed to investigate the effects of a simple cognitive task intervention on intrusive memories ("flashbacks") and associated symptoms following a traumatic event. Patients presenting to a Swedish emergency department (ED) soon after a traumatic event were randomly allocated (1:1) to the simple cognit...
Aims:
To examine the temporal trends and factors associated with national CR referral and compare the risk of hospital readmission and mortality in those referred for CR versus no referral.
Methods and results:
This cohort study includes all adult patients alive 120 days from incident HF identified by the Danish Heart Failure Register (n = 33,25...
Background:
Coronary heart disease (CHD) is the most common cause of death globally. However, with falling CHD mortality rates, an increasing number of people living with CHD may need support to manage their symptoms and prognosis. Exercise-based cardiac rehabilitation (CR) aims to improve the health and outcomes of people with CHD. This is an upd...
Aim:
The aim of this systematic review was to assess the effectiveness of rehabilitation interventions on the secondary physical, neurological and psychological consequences of cardiac arrest (CA) for adult survivors.
Methods:
A literature search of electronic databases (MEDLINE, Allied and Complementary Medicine Database, Cumulative Index to Nu...
Cardiac rehabilitation is a complex intervention that seeks to improve the functional capacity, wellbeing and health-related quality of life of patients with heart disease. A substantive evidence base supports cardiac rehabilitation as a clinically effective and cost-effective intervention for patients with acute coronary syndrome or heart failure...
Background
A subgroup of those with bipolar spectrum disorders experience ongoing mood fluctuations outside of full episodes. We conducted a randomised, controlled feasibility study of a Dialectical Behavioural Therapy-informed approach for bipolar mood fluctuations (Therapy for Inter-episode mood Variability in Bipolar [ThrIVe-B]). Our study aimed...
Objectives
To assess the effectiveness of cardiac rehabilitation (CR) in low- and middle-income countries (LMICs), given previous reviews have included scant trials from these settings and the great need there.
Methods
Six electronic databases (PubMed, Medline, Embase, CINAHL, Cochrane Library, and APA PsycINFO) were searched from inception-May 20...
Objective
To identify prognostic factors for health outcomes following an eight-week supervised exercise therapy and education program for individuals with knee and hip osteoarthritis (OA) alone or with concomitant hypertension, heart or respiratory disease, diabetes, or depression.
Methods
We included individuals with knee and/or hip OA from the...
Objective: To undertake meta-analysis and compare treatment effects estimated by the intention-to-treat (ITT) method and per-protocol (PP) method in randomised controlled trials (RCTs). PP excludes trial participant who are non-adherence to trial protocol in terms of eligibility, interventions, or outcome assessment.
Study design and setting: Five...
Background:
The impact of exercise-based cardiac rehabilitation (CR) following heart valve surgery is uncertain. We conducted an update of this systematic review and a meta-analysis to assess randomised controlled trial evidence for the use of exercise-based CR following heart valve surgery.
Objectives:
To assess the benefits and harms of exerci...
Introduction
The number of out-of-hospital cardiac arrest (OHCA) survivors is increasing. However, there remains limited knowledge on the long-term physical and psychological problems suffered by survivors and their relatives. The aims of the DANCAS (DANish cardiac arrest survivorship) survey are to describe the prevalence of physical and psycholog...
Objectives:
To undertake a detailed healthcare resource use and cost analysis of the SubQStim study, which randomized patients with failed back surgery syndrome (FBSS) with low back pain to receive subcutaneous nerve field stimulation in combination with optimized medical management (treatment) or optimized medical management alone (control).
Mat...
Background
Surrogate endpoints (i.e., intermediate endpoints intended to predict for patient-centered outcomes) are increasingly common. However, little is known about how surrogate evidence is handled in the context of health technology assessment (HTA).
Objectives
1) To map methodologies for the validation of surrogate endpoints and 2) to determ...
Spinal cord stimulation (SCS) has been suggested as a treatment option for patients with painful diabetic neuropathy (PDN). We conducted a systematic review and undertook a meta-analysis on individual patient data from randomised controlled trials (RCTs) to assess the effectiveness of SCS for the management of PDN. Electronic databases were searche...
Background
We will undertake an individual patient data (IPD) meta-analysis to assess the impact of exercise-based cardiac rehabilitation in patients with heart failure with preserved ejection fraction (HFpEF) on mortality and hospitalization and quality of life of exercise-based cardiac rehabilitation according to patient characteristics: age, sex...
Background
Rates of participation in centre (hospital)-cardiac rehabilitation by patients with heart failure are suboptimal. Heart failure has two main phenotypes differing in underlying pathophysiology: heart failure with reduced ejection fraction is characterised by depressed left ventricular systolic function (‘reduced ejection fraction’), where...
Spinal cord stimulation (SCS) is an interventional non-pharmacologic treatment used for chronic pain and other indications. Methods for evaluating the safety and efficacy of SCS have evolved from uncontrolled and retrospective studies to prospective randomized controlled trials (RCTs). While randomization overcomes certain types of bias, additional...
Objectives
Pilot feasibility randomised controlled trial (RCT) for the singing groups for people with aphasia (SPA) intervention to assess: (1) the acceptability and feasibility of participant recruitment, randomisation and allocation concealment; (2) retention rates; (3) variance of continuous outcome measures; (4) outcome measure completion and p...
Intrusive memories are common after trauma, and can cause significant distress. Interventions to prevent/reduce the occurrence of this core clinical feature of posttraumatic stress disorder are needed; they should be easy to deliver, readily disseminated and scalable. A novel one-session intervention by Iyadurai et al. 2018, Molecular Psychiatry, r...
OBJECTIVES
Methodological challenges in the evaluation of medical devices (MDs) may be different for early and late technology adopter countries, as well as the potential health technology assessment (HTA) solutions to tackle them. This study aims to provide guidance to Central and Eastern European (CEE) countries on how to address key challenges o...
Background
Whilst almost 50% of heart failure (HF) patients have preserved ejection fraction (HFpEF), evidence-based treatment options for this patient group remain limited. However, there is growing evidence of the potential value of exercise-based cardiac rehabilitation. This study reports the process evaluation of the Rehabilitation Enablement i...
This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effectiveness of social network and social support interventions to support cardiac rehabilitation and secondary prevention in the management of people with heart disease. As a secondary output of this review, and to assist in conceptualising futur...
Objectives
Spinal cord stimulation (SCS) is an established treatment of chronic neuropathic pain. Although a temporary SCS screening trial is widely used to determine suitability for a permanent implant, its evidence base is limited. The recent TRIAL‐STIM study (a randomized controlled trial at three centers in the United Kingdom) found no evidence...
Introduction
Despite evidence that cardiac rehabilitation (CR) is an essential component of care for people with heart failure, uptake is low. A centre-based format is a known barrier, suggesting that home-based programmes might improve accessibility. The aim of SCOT: Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) is to assess the im...
Objective:
To determine whether adding web-based support (e-coachER) to an exercise referral scheme (ERS) increases objectively assessed physical activity (PA).
Design:
Multicentre trial with participants randomised to usual ERS alone (control) or usual ERS plus e-coachER (intervention).
Setting:
Primary care and ERS in three UK sites from 201...
Background
Congenital heart disease (ConHD) affects approximately 1% of all live births. People with ConHD are living longer due to improved medical intervention and are at risk of developing non‐communicable diseases. Cardiorespiratory fitness (CRF) is reduced in people with ConHD, who deteriorate faster compared to healthy people. CRF is known to...