Rod Taylor

University of Exeter | UoE · Peninsula College of Medicine and Dentistry

Background Physical rehabilitation may improve health and wellbeing outcomes for some adults living with long COVID. However, individuals living with pre-existing multiple long-term conditions (MLTCs) and long COVID may have additional rehabilitation challenges. This scoping review aims to identify the available evidence describing physical rehabil...

Background Frailty is of increasing interest in trials, either as a target of intervention, as an outcome or as a potential treatment modifier. However, frailty measurement is often highly variable. This scoping review assessed how frailty is quantified in randomised controlled trials (RCTs), in what context and for what purposes. Methods We searc...

Background The Consolidated Standards of Reporting Trials (CONSORT) statement has improved the quality of reporting of randomised trials. Extensions to the CONSORT statement are often needed to address specific issues of trial reporting, including those relevant to particular types of interventions. Methodological and reporting deficiencies in clin...

Background The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement has improved the quality of reporting of randomised trial protocols. Extensions to the SPIRIT statement are needed to address specific issues of trial protocol reporting, including those relevant to particular types of interventions. Methodological...

Introduction Chronic pain is a personal experience influenced by multiple biopsychosocial factors. Using a pain intensity measure alone to assess the effectiveness of a chronic pain intervention fails to fully evaluate its impact on the multifaceted chronic pain experience. The holistic minimal clinically important difference (MCID) is a composite...

Background The SENZA-PDN study evaluated high-frequency 10-kHz spinal cord stimulation (SCS) for the treatment of painful diabetic neuropathy (PDN). Over 24 months, 10-kHz SCS provided sustained pain relief and improved health-related quality of life. This report presents additional outcomes from the SENZA-PDN study, focusing on diabetes-related pa...

During the past century, there have been major developments in the medical and surgical treatment of cardiovascular disease (CVD). These advancements have resulted in more people surviving initial events and having reduced length of stay in hospital; consequently, there is an increasing number of people in need of ongoing and lifelong cardiovascula...

Background: Atrial fibrillation (AF), the most prevalent cardiac arrhythmia, disrupts the heart's rhythm through numerous small re-entry circuits in the atrial tissue, leading to irregular atrial contractions. The condition poses significant health risks, including increased stroke risk, heart failure, and reduced quality of life. Given the comple...

Aims Depression and anxiety occur frequently in individuals with cardiovascular disease and are associated with poor prognosis. This Cochrane systematic review and meta-analysis assessed the effectiveness of psychological interventions on psychological and clinical outcomes in adults with coronary heart disease (CHD), heart failure (HF) or atrial f...

Randomised controlled trials often use surrogate endpoints to substitute for a target outcome (an outcome of direct interest and relevance to trial participants, clinicians, and other stakeholders—eg, all cause mortality) to improve efficiency (through shortened duration of follow-up, reduced sample size, and lower research costs), and for ethical...

Randomised controlled trials commonly use surrogate endpoints to substitute for a target outcome (outcome of direct interest and relevance to trial participants, clinicians, and other stakeholders—eg, all cause mortality) to improve their efficiency (through shorter trial duration, reduced sample size, and thus lower research costs), or for ethical...

Background It remains unclear how to meaningfully classify people living with multimorbidity (multiple long-term conditions (MLTCs)), beyond counting the number of conditions. This paper aims to identify clusters of MLTCs in different age groups and associated risks of adverse health outcomes and service use. Methods Latent class analysis was used...

Adaptation seeks to transfer and implement healthcare interventions developed and evaluated in one context to another. The aim of this scoping review was to understand current approaches to the adaptation of complex interventions for people with long-term conditions (LTCs) and to identify issues for studies performed in low- and middle-income count...

Importance Surrogate markers are increasingly used as primary end points in clinical trials supporting drug approvals. Objective To systematically summarize the evidence from meta-analyses, systematic reviews and meta-analyses, and pooled analyses (hereafter, meta-analyses) of clinical trials examining the strength of association between treatment...

Background: Depression and anxiety occur frequently (with reported prevalence rates of around 40%) in individuals with coronary heart disease (CHD), heart failure (HF) or atrial fibrillation (AF) and are associated with a poor prognosis, such as decreased health-related quality of life (HRQoL), and increased morbidity and mortality. Psychological...

Introduction: Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM) is a research programme that seeks to develop and evaluate a comprehensive exercise-based rehabilitation intervention designed for people with multimorbidity, the presence of multiple long-term conditions (MLTCs). This paper describes the pro...

INTRODUCTION Approximately 25% of people with diabetes experience painful diabetic neuropathy (PDN), but conventional medical management (CMM) is ineffective for many patients. We previously presented partial study results showing that high-frequency (10 kHz) spinal cord stimulation (SCS) provides substantial symptom relief. Here we report full stu...

Background Almost half of the global population face significant challenges from long-term conditions (LTCs) resulting in substantive health and socioeconomic burden. Exercise is a potentially key intervention in effective LTC management. Methods In this overview of systematic reviews (SRs), we searched six electronic databases from January 2000 t...

Aims Adapting interventions with an existing evidence base offers a more efficient approach than developing a new intervention. The aim of this study was to describe the process of adapting a home-based cardiac rehabilitation (CR) programme (REACH-HF) intervention originally developed in the UK for people with heart failure (HF) to the Danish healt...

Resistant hypertension (rHTN) is defined as blood pressure (BP) of ≥ 140/90 mmHg despite treatment with at least three antihypertensive medications, including a diuretic. Endovascular ultrasound renal denervation (uRDN) aims to control BP alongside conventional BP treatment with antihypertensive medication. This analysis assesses the cost effective...

This invited commentary refers to ‘Psychometric testing of the Care Dependency Scale in patients with heart failure and their caregivers’, by A. Durante et al. https://doi.org/10.1093/eurjcn/zvad117. Heart failure is a chronic condition affecting 1–2% of the general adult population in developed countries.1 Though survival has greatly improved, th...

Background: Cardiovascular disease is the most common cause of death globally. Traditionally, centre-based cardiac rehabilitation programmes are offered to individuals after cardiac events to aid recovery and prevent further cardiac illness. Home-based and technology-supported cardiac rehabilitation programmes have been introduced in an attempt to...

Background and Aims Despite strong evidence, access to exercise‐based cardiac rehabilitation (ExCR) remains low across global healthcare systems. We provide a contemporary update of the Cochrane review randomised trial evidence for ExCR for adults with heart failure (HF) and compare different delivery modes: centre‐based, home‐based (including digi...

Background Interventional trials that evaluate treatment effects using surrogate endpoints have become increasingly common. This paper describes four linked empirical studies and the development of a framework for defining, interpreting and reporting surrogate endpoints in trials.

Background Interventional trials that evaluate treatment effects using surrogate endpoints have become increasingly common. This paper describes four linked empirical studies and the development of a framework for defining, interpreting and reporting surrogate endpoints in trials. Methods As part of developing the CONSORT (Consolidated Standards o...

Background REACH-HF is a comprehensive home-based cardiac rehabilitation (CR) programme for people with heart failure (HF). The 3-day facilitator training has trained over 500 NHS staff across the UK to date. However, to address the NHS Long Term Plan aim of increasing uptake of CR in HF to 85%, more scalable formats of training delivery are requir...

Background The 2018 NICE guideline for chronic heart failure recommends that all eligible patients should receive cardiac rehabilitation, however participation remains less than 10%. The D:REACH-HF intervention, a digitally-adapted version of the clinically effective home-based cardiac rehabilitation programme (Rehabilitation Enablement in Chronic...

Introduction Latent class analysis (LCA) can be used to identify subgroups within populations based on unobserved variables. LCA can be used to explore whether certain long-term conditions (LTC) occur together more frequently than others in patients with multiple-long term conditions. In this manuscript we present findings from applying LCA in thre...

BACKGROUND: Diabetic peripheral neuropathy, a common comorbidity of diabetes, is a neurodegenerative disorder that targets sensory, autonomic, and motor nerves frequently associated with painful diabetic neuropathy (PDN). PDN carries an economic burden as the result of reduced work and productivity. A recent multicenter randomized controlled trial,...

Introduction The evidence for spinal cord stimulation (SCS) has been criticized for the absence of blinded, parallel randomized controlled trials (RCTs) and limited evaluations of the long-term effects of SCS in RCTs. The aim of this study was to determine whether evoked compound action potential (ECAP)-controlled, closed-loop SCS (CL-SCS) is assoc...

Aims: To evaluate the long-term efficacy of high-frequency (10 kHz) spinal cord stimulation (SCS) for treating refractory painful diabetic neuropathy (PDN). Methods: The SENZA-PDN study was a prospective, multicenter, randomized controlled trial that compared conventional medical management (CMM) alone with 10 kHz SCS plus CMM (10 kHz SCS+CMM) i...

Introduction Chronic pain patients may experience impairments in multiple health-related domains. The design and interpretation of clinical trials of chronic pain interventions, however, remains primarily focused on treatment effects on pain intensity. This study investigates a novel, multidimensional holistic treatment response to evoked compound...

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 images...

Cardiovascular disease is a leading cause of death, morbidity, disability, and reduced health-related quality of life, as well as economic burden worldwide, with some 80% of disease burden occurring in the low- and middle-income country (LMIC) settings. With increasing numbers of people living longer with symptomatic disease, the effectiveness and...

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...

Objectives: The effectiveness of Evoke closed-loop spinal cord stimulation (CL-SCS), a novel modality of neurostimulation, has been demonstrated in a randomised controlled trial (RCT). The objective of this cost-utility analysis was to develop a de novo economic model to estimate the cost-effectiveness Evoke CL-SCS when compared to open-loop SCS (...

Background: Globally, cardiovascular diseases (CVD, that is, coronary heart (CHD) and circulatory diseases combined) contribute to 31% of all deaths, more than any other cause. In line with guidance in the UK and globally, cardiac rehabilitation programmes are widely offered to people with heart disease, and include psychosocial, educational, heal...

Objective: To synthesise the current literature on the use of surrogate endpoints, including definitions, acceptability, and limitations of surrogate endpoints, and guidance for their design/reporting, into trial reporting items. Study design and setting: Literature was identified through searching bibliographic databases (until March 1st, 2022)...

Objective The purpose of this British Association for Cardiovascular Prevention and Rehabilitation (BACPR) research priority setting project (PSP) was to identify a top 10 list of priority research questions for cardiovascular prevention and rehabilitation (CVPR). Methods The PSP was facilitated by the BACPR clinical study group (CSG), which integ...

Introduction: The new European Union (EU) Regulations for medical devices (MDs) and health technology assessment (HTA) are welcome developments that will hopefully increase the quality of clinical evidence for MDs and reduce fragmentation in the EU market access process. To fully exploit anticipated benefits, their respective assessment processes...

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...

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...