Barnaby Reeves

• University of Bristol

Objectives Despite being a common side effect of stoma surgery, little is known about the health-related quality-of-life (HRQoL) impact of parastomal hernia (PSH). We studied the association between HRQoL and self-reported PSH using data from the large CIPHER prospective cohort study of patients living with a stoma. Methods Over 12 months, HRQoL w...

Purpose The Outcome Monitoring After Cardiac Surgery (OMACS) cohort study was set-up with the aim of establishing a rich source of biological samples and health status data from patients who undergo cardiac surgery. The objectives were to use these data to inform the design of new clinical studies and to provide samples and data to answer research...

Agre-related macular degeneration

Background Barth syndrome is a rare, life-threatening X-linked recessive mitochondrial disorder of lipid metabolism primarily affecting males. Previous research suggests that bezafibrate may ameliorate cellular lipid abnormalities and reduce cardiac dysfunction in an animal model. Objectives Estimate the effect of bezafibrate on clinical, biochemi...

Introduction Low back pain (LBP) is the leading global cause of disability. Patients with moderate to severe LBP who respond positively to a diagnostic medial nerve branch block can be offered radiofrequency denervation (RFD). However, high-quality evidence on the effectiveness of RFD is lacking. Methods and analysis RADICAL (RADIofrequenCy denerv...

This study formed part of a diagnostic test accuracy study to quantify the ability of three index home monitoring (HM) tests (one paper-based and two digital tests) to identify reactivation in Neovascular age-related macular degeneration (nAMD). The aim of the study was to investigate views about acceptability and explore adherence to weekly HM. Se...

Background Most neovascular age-related macular degeneration treatments involve long-term follow-up of disease activity. Home monitoring would reduce the burden on patients and those they depend on for transport, and release clinic appointments for other patients. The study aimed to evaluate three home-monitoring tests for patients to use to detect...

Background Neovascular age-related macular degeneration (nAMD) is a leading cause of blindness. The first-line therapy is anti-vascular endothelial growth factor (anti-VEGF) agents delivered by intravitreal injection. Ionising radiation mitigates key pathogenic processes underlying nAMD, and therefore has therapeutic potential. STAR aimed to assess...

Introduction The trial hypothesized that minimally invasive extra-corporeal circulation (MiECC) reduces the risk of serious adverse events (SAEs) after cardiac surgery operations requiring extra-corporeal circulation without circulatory arrest. Methods This is a multicentre, international randomized controlled trial across fourteen cardiac surgery...

Importance Most neovascular age-related macular degeneration (nAMD) treatments involve long-term follow-up of disease activity. Home-monitoring would reduce the burden on patients and their caregivers and release clinic capacity. Objective To evaluate 3 vision home-monitoring tests for patients to use to detect active nAMD compared with diagnosing...

Objectives Remote monitoring of health has the potential to reduce the burden to patients of face-to-face appointments and make healthcare more efficient. Apps are available for patients to self-monitor vision at home, for example, to detect reactivation of age-related macular degeneration (AMD). Describing the challenges when implementing apps for...

Purpose To describe inequalities in the Monitoring for Neovascular Age-related Macular Degeneration Reactivation at Home (MONARCH) diagnostic test accuracy study for: recruitment; participants’ ability to self-test; and adherence to testing using digital applications during follow-up. Methods Home-monitoring vision tests included two tests impleme...

Introduction Adalimumab is an effective treatment for autoimmune non-infectious uveitis (ANIU), but it is currently only funded for a minority of patients with ANIU in the UK as it is restricted by the National Institute for Health and Care Excellence guidance. Ophthalmologists believe that adalimumab may be effective in a wider range of patients....

Objectives Bariatric surgery is an effective treatment for severe obesity that leads to significant physical health improvements. Few studies have prospectively described the short-term impact of surgery on mental health using standardised case-finding measures for anxiety or depressive disorders. This study describes the prevalence and short-term...

Aim The aim was to develop and pilot a patient‐reported outcome measure (PROM) to assess symptoms of parastomal hernia (PSH). Methods Standard questionnaire development was undertaken (phases 1–3). An initial list of questionnaire domains was identified from validated colorectal cancer PROMs and from semi‐structured interviews with patients with a...

Objective This paper reports the study design, participant characteristics, and recruitment results of By‐Band‐Sleeve, which investigated the clinical and cost‐effectiveness of gastric bypass, gastric banding, and sleeve gastrectomy in adults with severe obesity in the UK. Methods A pragmatic open adaptive noninferiority trial with 3‐year follow‐u...

Objectives: Intermittent cold blood cardioplegia is commonly used in children whereas intermittent warm blood cardioplegia is widely used in adults. We aimed to compare clinical and biochemical outcomes with these two methods. Methods: A single centre, randomized controlled trial was conducted to compare the effectiveness of warm (≥34°C) versus...

Background/aim Clinical assessment of wounds for surgical site infection (SSI) after hospital discharge is challenging and resource intensive. Remote assessment using digital images may be feasible and expedite SSI diagnosis. Acceptable and accurate methods for this process are needed. This study developed and evaluated the feasibility, acceptabili...

Introduction More than 30 000 cardiac surgery procedures are performed in the UK each year, however, postoperative complications and long-term failure of interventions are common, leading to repeated surgeries. This represents a significant burden on the patient and health service. Routinely, patients are discharged to their general practitioner 6...

Background Myocardial infarction induces elevation of progenitor cells in the circulation, a reparative response inhibited by type-2 diabetes. Objectives Determine if myocardial infarct severity and diabetes interactively influence the migratory activity of CD34+/CXCR4+ progenitor cells and if the migratory test predicts cardiac outcomes. Materia...

Neovascular age-related macular degeneration (nAMD) is a chronic, progressive condition and the commonest cause of visual disability in older adults. This study formed part of a diagnostic test accuracy study to quantify the ability of three index home monitoring (HM) tests (one paper-based and two digital tests) to identify reactivation in nAMD. T...

Objectives To describe the development and application of methods to optimise the design of case report forms (CRFs) for clinical studies evaluating surgical procedures, illustrated with an example of abdominal stoma formation. Design (1) Literature reviews, to identify reported variations in surgical components of stoma formation, were supplement...

Concerns have been expressed about the relationship between reduced levels of health care utilisation and the COVID-19 pandemic. This study aimed to elicit and explore the views of patients with neovascular age-related macular degeneration (nAMD) regarding the COVID-19 pandemic and their ophthalmic care. Semi-structured telephone interviews were co...

Our earlier work has shown inter‑disease and intra‑disease differences in the cardiac proteome between right (RV) and left (LV) ventricles of patients with aortic valve stenosis (AVS) or coronary artery disease (CAD). Whether disease remodeling also affects acute changes occuring in the proteome during surgical intervention is unknown. This study i...

Background When a cardiac arrest occurs, cardiopulmonary resuscitation should be started immediately. However, there is limited evidence about the best approach to airway management during cardiac arrest. Objective The objective was to determine whether or not the i-gel ® (Intersurgical Ltd, Wokingham, UK) supraglottic airway is superior to trache...

Objective/purpose: To describe the frequency of long-term morphological features and their relationships with visual function in participants who exited the inhibition of VEGF in age-related choroidal neovascularization (IVAN: ISRCTN92166560) trial. Design: Multicenter cohort study up to 7 years after enrolment. Participants: Patients enrolled...

Objectives To identify potential confounders and co-interventions systematically to optimise control for confounding for three non-randomized studies of interventions (NRSI) designed to quantify bleeding in populations exposed to different dual antiplatelet therapies (DAPT). Study Design and Setting Systematic review, interviews and surveys with c...

Background Opinions and practices vary around the issue of performing multiple statistical tests in randomised controlled trials (RCTs). We carried out a study to collate information about opinions and practices using a methodological rapid review and a survey, specifically of publicly funded pragmatic RCTs that are not seeking marketing authorisat...

Background Neovascular (wet) age-related macular degeneration (AMD) can be associated with large submacular haemorrhage (SMH). The natural history of SMH is very poor, with typically marked and permanent loss of central vision in the affected eye. Practice surveys indicate varied management approaches including observation, intravitreal anti-vascul...

Purpose: To compare demographics, visual acuity (VA) and retinal morphology between those with and without baseline submacular haemorrhage (SMH) for patients enrolled in the Inhibit VEGF in Age-related Choroidal Neovascularisation trial (IVAN). Design: Secondary analyses of RCT image and clinical data. Methods: Setting: Clinical trial data col...

Background/aims Concerns have been expressed about the relationship between reduced levels of health care utilisation and the COVID-19 pandemic. This study aimed to elicit and explore the views of patients with neovascular age-related macular degeneration (nAMD) regarding the COVID-19 pandemic and their ophthalmic care. Methods Between April 29th a...

Background The use of placebo comparisons for randomised trials assessing the efficacy of surgical interventions is increasingly being considered. However, a placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. Objectives To provide a summary of knowledge on placebo control...

Aim Optimal airway management during out-of-hospital cardiac arrest (OHCA) is uncertain. Complications from tracheal intubation (TI) may be avoided with supraglottic airway (SGA) devices. The AIRWAYS-2 cluster randomised controlled trial (ISRCTN08256118) compared the i-gel SGA with TI as the initial advanced airway management (AAM) strategy by para...

Background Barth syndrome is a rare, life-threatening, X-linked recessive genetic disease that predominantly affects young males and is caused by abnormal mitochondrial lipid metabolism. Currently, there is no definitive treatment for Barth syndrome other than interventions to ameliorate acute symptoms, such as heart failure, cardiac arrhythmias, n...

Objectives To develop an operational definition of contextual factors (CF) [1]. Methods Based on previously conducted interviews, we presented three CF types in a Delphi survey; Effect Modifying -, Outcome Influencing - and Measurement Affecting CFs. Subsequently, a virtual Special Interest Group (SIG) session was held for in depth discussion of E...

Background In chronic central serous chorioretinopathy, fluid accumulates in the subretinal space and causes permanent vision loss in ≈ 30% of patients. There is no definitive treatment. Previous research suggests that the mineralocorticoid receptor antagonist eplerenone is effective but it is not licensed for chronic central serous chorioretinopat...

Background To assess differences in platelet inhibition during ticagrelor monotherapy (TIC) or dual therapy with ticagrelor and aspirin (TIC+ASP) in patients after percutaneous coronary intervention using a comprehensive panel of functional tests. Methods and Results In a single‐center parallel group, open label, randomized controlled trial, 110 p...

Aim The AIRWAYS-2 cluster randomised controlled trial compared the i-gel supraglottic airway device (SGA) with tracheal intubation (TI) as the first advanced airway management (AAM) strategy used by Emergency Medical Service clinicians (paramedics) treating adult patients with non-traumatic out-of-hospital cardiac arrest (OHCA). It showed no differ...

Introduction Surgical repair of congenital heart defects often requires the use of cardiopulmonary bypass (CPB) and cardioplegic arrest. Cardioplegia is used during cardiac surgery requiring CPB to keep the heart still and to reduce myocardial damage as a result of ischaemia–reperfusion injury. Cold cardioplegia is the prevalent method of myocardia...

Objectives The Outcome Measures in Rheumatology Initiative established the Contextual Factors Working Group to guide the understanding, identification and handling of contextual factors for clinical trials. In clinical research, different uses of the term ‘contextual factors’ exist. This study explores the perspectives of researchers (including cli...

Background: Corticosteroids are routinely given to children undergoing cardiac surgery with cardiopulmonary bypass (CPB) in an attempt to ameliorate the inflammatory response. Their use is still controversial and the decision to administer the intervention can vary by centre and/or by individual doctors within that centre. Objectives: This revie...

Importance When initiating anti–vascular endothelial growth factor (VEGF) treatment for patients with neovascular age-related macular degeneration (nAMD), knowledge of prognostic factors is important for advising patients and guiding treatment. We hypothesized that eyes with greater fluctuation in retinal thickness over time have worse outcomes tha...

Introduction: Despite low mortality, cardiac surgery patients may experience serious life-threatening post-operative complications, often due to extracorporeal circulation and reperfusion. Miniaturised cardiopulmonary bypass (minimally invasive extracorporeal circulation) has been developed aiming to reduce the risk of post-operative complications...

BACKGROUND Barth syndrome is a rare, life-threatening, X-linked recessive genetic disease that predominantly affects young males and is caused by abnormal mitochondrial lipid metabolism. Currently, there is no definitive treatment for Barth syndrome other than interventions to ameliorate acute symptoms, such as heart failure, cardiac arrhythmias, n...

This study aims to quantify the diagnostic test-accuracy of three visual function self-monitoring tests for detection of active disease in patients with neovascular age-related macular degeneration (nAMD) when compared with usual care. An integrated qualitative study will investigate the acceptability of these home-based testing strategies. All con...

Introduction: AIRWAYS-2 was a cluster randomised controlled trial (RCT) comparing the clinical and cost effectiveness of the i-gel supraglottic airway device with tracheal intubation in the initial airway management of out-of-hospital cardiac arrest (OHCA). In order to successfully conduct this clinical trial, it was necessary for research paramed...

Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this Review is to provide a summary of knowledge on placebo controls in surgical trials. A placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challe...

Purpose To describe visual outcomes, frequency of treatment and monitoring visits, and anti-vascular endothelial growth factor drugs used in usual care in participants who exited a trial in which treatment for neovascular age-related macular degeneration (nAMD) was initiated with bevacizumab or ranibizumab. Design Multi-centre cohort study up to 7...

Background: In chronic central serous chorioretinopathy (CSCR), fluid accumulates in the subretinal space. CSCR is a common visually disabling condition that develops in individuals up to 60 years of age, and there is no definitive treatment. Previous research suggests the mineralocorticoid receptor antagonist, eplerenone, is effective for treatin...

Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this paper is to provide a summary of current knowledge on placebo controls in surgical trials. A placebo control is a complex type of comparison group and, although powerful, presents many challenges in a surgica...

Introduction Burn care represents a healthcare and economic burden to patients internationally. Choice of the most clinically effective treatment strategies requires evidence which is best obtained through high-quality randomised controlled trials (RCT). The number of published RCTs of burn care is increasing. However, trial quality and reporting s...

Background: In chronic central serous chorioretinopathy (CSCR), fluid accumulates in the sub-retinal space. It is a common visually disabling condition in individuals of working age. There is no definitive treatment. Previous research suggests the mineralocorticoid receptor antagonist, eplerenone, is effective for treating CSCR but it is not licens...

In the original publication of this article [1], the author noted two corrections after publication.

The revised edition of the Handbook offers the only guide on how to conduct, report and maintain a Cochrane Review. The second edition of The Cochrane Handbook for Systematic Reviews of Interventions contains essential guidance for preparing and maintaining Cochrane Reviews of the effects of health interventions. Designed to be an accessible resou...

Assessment of risk of bias is regarded as an essential component of a systematic review on the effects of an intervention. The most commonly used tool for randomised trials is the Cochrane risk-of-bias tool. We updated the tool to respond to developments in understanding how bias arises in randomised trials, and to address user feedback on and limi...

Background Surgical site infection (SSI) affects up to 20% of people with a primary closed wound after surgery. Wound dressings may reduce SSI. Objective To assess the feasibility of a multicentre randomised controlled trial (RCT) to evaluate the effectiveness and cost-effectiveness of dressing types or no dressing to reduce SSI in primary surgica...

Objective To identify the key drivers of cost-effectiveness for cardiovascular magnetic resonance (CMR) when patients activate the primary percutaneous coronary intervention (PPCI) pathway. Design Economic decision models for two patient subgroups populated from secondary sources, each with a 1 year time horizon from the perspective of the National...

Background Cardiovascular magnetic resonance (CMR) is increasingly used in patients who activate the primary percutaneous coronary intervention (PPCI) pathway to assess heart function. It is uncertain whether having CMR influences patient management or the risk of major adverse cardiovascular events in these patients. Objective To determine whethe...

Background: We determined whether it is feasible to identify important changes in care management resulting from cardiovascular magnetic resonance (CMR) in patients who activate the primary percutaneous coronary intervention (PPCI) pathway from hospital episode data, in order to construct a composite primary outcome (hypothesised to reduce the ris...

Introduction: 'Real world' bleeding in patients exposed to different regimens of dual antiplatelet therapy (DAPT) and triple therapy (TT, DAPT plus an anticoagulant) have a clinical and economic impact but have not been previously quantified. Methods and analysis: We will use linked Clinical Practice Research Datalink (CPRD) and Hospital Episode...

Objectives: This trial was designed and patients were recruited at a time when the benefits of remote ischaemic preconditioning during open-heart surgery were still controversial. We focused on a homogeneous patient population undergoing either isolated aortic valve replacement or coronary artery bypass grafting (CABG) surgery by investigating car...

Introduction Patients with congenital heart disease often need repeated operations throughout life to replace the pulmonary valve. Valve replacement with ‘injectable’ self-expanding valves (which is performed ‘off pump’ without the use of cardiopulmonary bypass, CPB) may result in quicker recovery and lower risk of major complications than valve re...

This study aimed to optimise techniques for whole transcriptome and small RNA analyses on clinical tissue samples from patients with cardiovascular disease. Clinical samples often represent a particular challenge to extracting RNA of sufficient quality for robust RNA sequencing analysis, and due to availability, it is rarely possible to optimise te...

Capillary electrophoresis quantification of pig LV biopsy RNA. Bioanalyzer Nano chip quantification of LV biopsy RNA was similar to the spectrophotometry quantification presented in Fig 2A. RNA extracted according to each manufacturer’s protocol, with the addition of a proteinase K digestion in half the samples. n = 3 biopsies/experimental conditio...

miRNA screening in pig plasma RNA. Two randomly selected pig plasma RNA samples were screened for the presence of 7 candidate circulating miRNAs predicted to be conserved between humans and pigs. (TIF)

The top 35 miRNAs detected in human LV biopsy RNA. The expression levels of the top 35 miRNAs in LV biopsies are plotted as log2 normalised counts. For each plotted miRNA, the box indicates the upper (75%) and lower (25%) quartiles of the counts with a straight black line within the box indicating the median. The whiskers of the box indicate counts...

Raw data underlying all data figures are available in the zipped folder “S1_Data.zip” in csv format. (ZIP)

miRNA screening in human plasma RNA. The expression levels in human plasma of the 7 candidate circulating miRNAs from pig plasma. Mean Cq values are expressed after inter-plate calibration. (TIF)

Supplemental methods and results table. An expanded methods section and Table B in S1 File can be found in the online supplement, “supplemental methods and results table.docx”. (DOCX)

Evaluating the effect of biopsy mass on RNA yield and integrity. (A) RNA yield is constant over the range of biopsy masses from 1–6 μg. Linear regression y = −0.0161x + 1.326 (B) For biopsies weighing <1 mg, the yield is no longer constant; non-linear regression, least-squares fit y = 1.503x−0.4715 (C) The RIN remains constant across the range of b...

Comparison of elution volumes for the mirVana protocol. The mirVana protocol recommends elution in 100 μL water; with small tissue samples this can result in a sample too dilute for some downstream applications. Reducing the elution volume to 50 or 30 μL produced a more concentrated preparation without appreciable loss of RNA yield, measured by spe...

Background The research study titled “Cluster randomised trial of the clinical and cost effectiveness of the i-gel supraglottic airway device versus tracheal intubation in the initial airway management of out-of-hospital cardiac arrest (AIRWAYS-2)” is a large-scale study being run in the English emergency medical (ambulance) services (EMS). It comp...

Purpose: To report on the development and progression of macular atrophy (MA) and its relationship with morphologic and functional measures in study and fellow eyes in the Inhibition of vascular endothelial growth factor (VEGF) in Age-related Choroidal Neovascularisation trial. Design: Reading center analysis of data from a randomized controlled...

Objective: To evaluate the impact of the QuinteT Recruitment Intervention (QRI) on recruitment in challenging randomized controlled trials (RCTs) that have applied the intervention. The QRI aims to understand recruitment difficulties and then implements "QRI actions" to address these as recruitment proceeds. Study design and setting: A mixed-met...

Background: Dual antiplatelet therapy (DAPT) is the recommended preventative treatment for secondary ischaemic events, but increases the risk of bleeding, potentially affecting patients' health-related quality-of-life (HRQoL). Varied utility decrements have been used in cost-effectiveness models assessing alternative DAPT regimens, but it is uncle...

Aims: Chronic central serous chorioretinopathy (CSCR) is poorly understood. Fluid accumulates in the subretinal space and retinal pigment epitheliopathy and neurosensory atrophy may develop. Permanent vision loss occurs in approximately one third of cases. There are no effective treatments for CSCR. Recent studies have shown the mineralocorticoid...

Objective: To develop ROBIS, a new tool for assessing the risk of bias in systematic reviews (rather than in primary studies). Study design and setting: We used four-stage approach to develop ROBIS: define the scope, review the evidence base, hold a face-to-face meeting, and refine the tool through piloting. Results: ROBIS is currently aimed a...

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the benefits and harms of prophylactic corticosteroids in children between birth and 18 years of age undergoing cardiac surgery with cardiopulmonary bypass.

Importance The optimal approach to airway management during out-of-hospital cardiac arrest is unknown. Objective To determine whether a supraglottic airway device (SGA) is superior to tracheal intubation (TI) as the initial advanced airway management strategy in adults with nontraumatic out-of-hospital cardiac arrest. Design, Setting, and Partici...

Abstract Background We estimated the effectiveness of serial B-type natriuretic peptide (BNP) blood testing to guide up-titration of medication compared with symptom-guided up-titration of medication in patients with heart failure (HF). Methods Systematic review and meta-analysis of randomised controlled trials (RCTs). We searched: MEDLINE (Ovid) 1...

Objectives To determine whether it is feasible to set up a national registry, linking routinely collected data from hospital information systems (HIS), to investigate the role of cardiovascular magnetic resonance (CMR) in patients who activate the primary percutaneous coronary intervention (PPCI) pathway. Design Feasibility prospective cohort stud...