Showing papers by "Rod S Taylor published in 2022"

Screening trials of spinal cord stimulation for neuropathic pain in England—A budget impact analysis

Abstract: 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 considering a study population that reflects the size and characteristics of a patient population with neuropathic pain in England eligible for SCS. The perspective adopted was that of the NHS with a 5-year time horizon. The base case analysis indicate that a no screening trial strategy would result in cost-savings to the NHS England of £400,000–£500,000 per year. Sensitivity analyses were conducted to evaluate different scenarios. If ≥5% of the eligible neuropathic pain population received a SCS device, cost-savings would be >£2.5 million/year. In contrast, at the lowest assumed cost of a screening trial (£1,950/patient), a screening trial prior to SCS implantation would be cost-saving. The proportion of patients having an unsuccessful screening trial would have to be ≥14.4% for current practice of a screening trial to be cost-saving. The findings from this budget impact analysis support the results of a recent UK multicenter randomized controlled trial (TRIAL-STIM) of a policy for the discontinuation of compulsory SCS screening trials, namely that such a policy would result in considerable cost-savings to healthcare systems.

Informed decision‐making: Statistical methodology for surrogacy evaluation and its role in licensing and reimbursement assessments

Abstract: 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 the theme of statistical support for decision‐making in health technology assessment (HTA). Following the pioneering methodology based on hypothesis testing that Prentice presented in 1989, a host of further methods, both frequentist and Bayesian, have been developed to enable the value of a putative surrogate outcome to be determined. This rich methodological seam has generated practical methods for surrogate evaluation, the most recent of which are based on the principles of information theory and bring together ideas from the causal effects and causal association paradigms. Following our synopsis of statistical methods, we then consider how regulatory authorities (on licensing) and payer and HTA agencies (on reimbursement) use clinical trial evidence based on surrogate outcomes. We review existing HTA surrogate outcome evaluative frameworks. We conclude with recommendations for further steps: (1) prioritisation by regulators and payers of the application of formal surrogate outcome evaluative frameworks, (2) application of formal Bayesian decision‐analytic methods to support reimbursement decisions, and (3) greater utilization of conditional surrogate‐based licensing and reimbursement approvals, with subsequent reassessment of treatments in confirmatory trials based on final patient‐relevant outcomes.

Evaluation of a complex intervention for prisoners with common mental health problems, near to and after release: the Engager randomised controlled trial

Abstract: 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 trial that was conducted in the North West and South West of England (ISRCTN11707331). Men serving a prison sentence of 2 years or less were individually allocated 1:1 to either the intervention (Engager plus usual care) or usual care alone. Engager included psychological and practical support in prison, on release and for 3–5 months in the community. The primary outcome was the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM), 6 months after release. Primary analysis compared groups based on intention-to-treat (ITT). Results In total, 280 men were randomised out of the 396 who were potentially eligible and agreed to participate; 105 did not meet the mental health inclusion criteria. There was no mean difference in the ITT complete case analysis between groups (92 in each arm) for change in the CORE-OM score (1.1, 95% CI –1.1 to 3.2, P = 0.325) or secondary analyses. There were no consistent clinically significant between-group differences for secondary outcomes. Full delivery was not achieved, with 77% (108/140) receiving community-based contact. Conclusions Engager is the first trial of a collaborative care intervention adapted for prison leavers. The intervention was not shown to be effective using standard outcome measures. Further testing of different support strategies for prison with mental health problems is needed.

Long-term effects of cardiac rehabilitation after heart valve surgery - results from the randomised CopenHeartVR trial

Abstract: Abstract 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 health and effect on mortality and readmission rates as prespecified in the original protocol. Methods. A total of 147 participants were included after heart valve surgery and randomly allocated 1:1 to 12-weeks exercise-based CR including a psycho-educational programme (intervention group) or control. Physical capacity was assessed as peak oxygen uptake (VO2 peak) measured by cardiopulmonary exercise testing, mental and physical health by Short Form-36 questionnaire, Hospital Anxiety and Depression Scale, and HeartQol. Mortality and readmission were obtained from hospital records and registers. Groups were compared using mixed regression model analysis and log rank test. Results. No differences in VO2 peak at 12 months or in self-assessed mental and physical health at 24 months (68% vs 75%, p = .120) was found. However, our data demonstrated reduction in readmissions in the intervention group at intermediate time points; after 3, 6 (43% vs 59%, p = .03), and 12 (53% vs 67%, p = .04) months, respectively, but no significant effect at 24 months. Conclusions . Exercise-based CR after heart valve surgery reduces combined readmissions and mortality up to 12 months despite lack of improvement in exercise capacity, physical and mental health long-term. Exercise-based CR can ensure short-term benefits in terms of physical capacity, and lower readmission within a year, but more research is needed to sustain these effects over a longer time period. These considerations should be included in the management of patients after heart valve surgery.

22-LB: 24-Month Results for 10-kHz Spinal Cord Stimulation (SCS) in Treating Painful Diabetic Neuropathy (PDN)

Abstract: Background and aims: PDN can lead to severe deterioration in quality of life. While published data demonstrate 10kHz SCS provides substantial refractory pain relief and neurologic improvement for PDN patients1, here we report durability of these outcomes. Methods: Prospective, multicenter, RCT to document the impact of 10kHz SCS on PDN. Participants had PDN symptoms ≥12 months (M) , refractory to medications, lower limb pain intensity ≥5cm (0-10cm visual analog scale [VAS]) , and hemoglobin A1c ≤10%. Patients (N=216) were allocated 1:1 to 10kHz SCS (Nevro Corp.) plus conventional medical management (CMM) or CMM alone with optional crossover at 6 M. Results: The 10kHz SCS patients maintained substantial pain relief from 3 M, averaging 81.9% (95%CI 77.3 - 86.5) decrease at 24 M. At 6 M follow up, 0% of 10kHz SCS participants but 93% of eligible CMM patients elected to crossover. After SCS, both groups reported similar significant improvements in pain, sleep disturbance, and in pain interference with mood and daily activities (see Figure 1) . There were no stimulation-related neurological deficits and 6 total explants (3.9%) , 5 due to procedure-related infections and 1 as a precaution for endocarditis. Conclusions: The largest RCT to date of SCS management of PDN demonstrates safety, durable pain relief and neurologic improvement over 24 months with 10 kHz SCS. E. Petersen: Consultant; Abbott, Biotronik, Boston Scientific Corporation, Medtronic, Nalu, Neuros Medical, Nevro Corp., Presidio, Saluda Medical, Vertos Medical Inc., Research Support; Medtronic, Neuros Medical, Nevro Corp., ReNeuron, Saluda Medical, SPR, Stock/Shareholder; neuro42, SynerFuse. C. Yu: Consultant; Boston Scientific Corporation, Nevro Corp., Research Support; Nevro Corp. A. Nairizi: Consultant; Nevro Corp. D. G. Patterson: Advisory Panel; AIS, Consultant; Pajunk Medical, Other Relationship; Abbott, CornerLoc, Flowonix, Saluda Medical, Vertiflex, Vertos, Vivex Biologics, Research Support; Nevro Corp., Speaker’s Bureau; AbbVie Inc., Lundbeck. V. Galan: None. R. Bundschu: None. N. Mehta: Consultant; Nevro Corp. D. Sayed: Consultant; Nevro Corp. D. Dibenedetto: None. K. A. Sethi: None. P. W. Wu: None. T. G. Stauss: None. C. Argoff: Consultant; Nevro Corp. C. E. Nasr: Advisory Panel; Exelixis, Horizon Therapeutics plc, Neurogastrx, Nevro Corp., Research Support; Siemens. R. Taylor: Consultant; Nevro Corp. D. L. Caraway: Employee; Nevro Corp. J. A. Scowcroft: Research Support; Boston Scientific Corporation, Nevro Corp., Saluda Medical. E. Brooks: Employee; Nevro Corp., Presidio Medical, Stock/Shareholder; Nevro Corp., Presidio Medical. J. L. White: Advisory Panel; Nevro Corp. S. M. Sills: None. K. Amirdelfan: Consultant; Nevro Corp. M. Guirguis: Advisory Panel; Averitas Pharma, Inc., Boston Scientific Corporation, Pacira BioSciences, Inc., Consultant; Avanos Medical, Inc., Nevro Corp., OmniaMed, Saluda Medical. J. Xu: None. Nevro Corp.

Identifying the Optimal Exercise Prescription for Patients with Coronary Artery Disease Undergoing Cardiac Rehabilitation: Protocol for a Systematic Review and Network Meta-Analysis of Randomized Control Trials

Abstract: 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-analysis (NMA) aims to formally quantify the optimal dose of exercise training interventions to improve exercise capacity and quality of life by undertaking direct and indirect pooled comparisons of randomized controlled trials. A detailed search will be conducted on PubMed/MEDLINE, Cumulative Index to Nursing and Allied Health (CINAHL), EMBASE and Web of Science. Two reviewers will screen the existing literature and assess the quality of the studies. Disagreements will be resolved through consensus. We anticipate that the analysis will include pairwise and Bayesian network meta-analyses. Most of the trials have studied the impact of exercise training comparing one or two modalities. As a result, little evidence exists to support which interventions will be most effective. The current NMA will address this gap in the literature and assist clinicians and cardiac rehabilitation specialists in making an informed decision. Results will be disseminated through peer-reviewed journals. Ethical approval is not applicable, as no research participants will be involved. PROSPERO Registration number: CRD42022262644.

Spinal Cord Stimulation for Neuropathic Pain in England From 2010 to 2020: A Hospital Episode Statistics Analysis.

Abstract: 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 National Health Service in England up to 2020.Hospital Episode Statistics were obtained for patients with neuropathic pain potentially eligible for SCS and patients receiving an SCS-related procedure. Data were retrieved nationally and per region from the years 2010-2011 to 2019-2020.There were 50,288 adults in England attending secondary care with neuropathic pain in 2010-2011, increasing to 66,376 in 2019-2020. The number of patients with neuropathic pain with an SCS procedure increased on a year-to-year basis until 2018-2019. However, less than 1% of people with neuropathic pain received an SCS device with no evidence of an increase over time when considering the background increase in neuropathic pain prevalence.Only a small proportion of patients in England with neuropathic pain potentially eligible for SCS receives this intervention. The recommendation for routine use of SCS for management of neuropathic pain has not resulted in an uptake of SCS over the last decade.

Association Between Levels of Functional Disability and Health-Related Quality of Life With Spinal Cord Stimulation for Chronic Pain.

Abstract: 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 of this study were to 1) investigate the association between functional disability and HRQoL and 2) estimate the utility values associated with levels of functional disability in patients treated with evoked compound action potential (ECAP) spinal cord stimulation (SCS) for chronic pain.Data on functional disability assessed using the Oswestry Disability Index (ODI) and HRQoL (EQ-5D-5L) were collected from 204 patients with an Evoke ECAP-SCS device and followed up to 12 months. SF-6D utility scores also were retrieved for 134 of these patients. Multivariable linear regression models adjusted for baseline utility values and patient demographics were used to compare differences in utility values across ODI categories.Significant improvements in functional disability and HRQoL were observed at three- and 12-month follow-up after SCS. Patients reporting "minimum disability," "moderate disability," "severe disability," and "crippled" had mean EQ-5D scores of 0.82, 0.73, 0.59, and 0.45, respectively. The mean change in EQ-5D score was 0.007 per unit change in total ODI score. The R2 statistic showed a moderate level association (49%-64% of variance in EQ-5D explained by ODI).ECAP-SCS results in significant improvements in functional disability and HRQoL. This study shows that improvement in function of people with chronic pain before and after ECAP-SCS is associated with improvement in HRQoL.

118 Real world implementation of an evidence-based home cardiac rehabilitation programme for people with heart failure and their caregivers: findings from the scot:reach-hf study

Abstract: 117 Figure 2 Abstracts Heart 2022;108(Suppl 1):A1–A184 A89 on Jne 2, 2023 by gest. P rocted by coright. httpeart.bm jcom / H ert: frst pulished as 10.113artjnl-2022-B C S .18 on 6 Jne 222. D ow nladed fom provision is a known barrier, and the need for flexible models of CR has become more pronounced in the recent pandemic context. In a multicentre randomised controlled trial of the REACH-HF home-based self-management support programme for HFrEF demonstrated its clinical and cost-effectiveness. However, full understanding of its implementation is needed to inform scaled roll-out in a ‘real world’ NHS setting. The SCOT:REACH-HF study aimed to 1) compare outcome improvements with those identified in the RCT, 2) identify facilitators of and barriers to real-world implementation, and 3) estimate of the economic impact of implementation. Methods We conducted a mixed-method implementation study of the delivery of REACH-HF in across NHS Scotland in 2021–22. Health professionals were trained to facilitate delivery of the 12-week programme to people with heart failure and a nominated ‘caregiver’ where applicable. Patient and caregiver outcomes assessed at baseline and four-month follow-up included the Minnesota Living with Heart Failure Questionnaire, EQ-5D-5L, Hospital Anxiety and Depression Scale, Health Literacy Questionnaire, and Caregiver Burden Questionnaire. Qualitative interviews were conducted with key health professionals and stakeholders, and analysis of broader contextual implementation data was also incorporated. Results and Conclusions We recruited 136 people with HFrEF in six health board areas (NHS Ayrshire and Arran, Lanarkshire, Forth Valley, Highland, Orkney and Shetland) serving urban and rural populations. Of those, 124 completed baseline, 113 completed REACH-HF, and 99 completed 4-month follow-up. 47 participants brought caregivers into the study, with 29 of those completing the programme, and 20 completing follow-up. Semi-structured interviews were conducted with 11 trained REACH-HF facilitators, five supporting team members/managers, and four national stakeholders. We will report changes seen in patient and caregiver outcomes following participation in REACH-HF, present barriers and facilitators identified in the qualitative interviews, and discuss implications for the wider implementation and sustainability of the REACHHF programme. Conflict of Interest None 119 WHAT ARE THE EFFECTS OF COVID-19 ON HEART FAILURE ADMISSION RATES AND MORTALITY? Sundas Tahir Masudi, Prince Josiah Joseph, Amna Rahman, Jameela Bahar, Abdullah Abdullah, Kenneth Wong. Dept. of Cardiology, Lancashire Cardiac Centre, Blackpool Teaching Hospitals NHS Foundation Trust, University of Liverpool, Liverpool, MSY L69 7ZX, United Kingdom; Dept. of Cardiology, Lancashire Cardiac Centre, Blackpool Teaching Hospitals NHS Foundation Trust 10.1136/heartjnl-2022-BCS.119 Introduction Near the beginning of the COVID-19 pandemic, a reduction in ST elevation myocardial infarction (STEMI) presentation was reported. We hypothesise that this may lead to a substantial increase in heart failure (HF) admissions and an increase in HF mortality. Methods Consecutive admissions with HF to Blackpool Victoria hospital were categorised into three groups: preCOVID era (defined as 01/08/2019 to 31/01/2020), first COVID wave (01/02/2020 to 31/07/2021) and the third group is second COVID wave (01/08/2021 to 31/01/2021). Inpatient mortality was the primary end point. Patients were followed up for 60 days. Secondary end point was readmissions within 60 days. Results There were 1178 consecutive episodes of admissions with heart failure (first diagnostic position) over 18 months. 140 inpatient deaths occurred (11.8% in-hospital mortality). Three-hundred and forty one consecutive episodes of HF admissions during the 6 months of the preCOVID era were seen. A substantial increase in number of HF presentations was observed in the first wave (422 episodes). During the second wave, this remained high compared with the pre-COVID era415 episodes. In the pre-COVID era, 35/341(10%) died as inpatient. During the first wave, mortality remained 10% (41/422). However, there was statistically significant increase in mortality with the second wave, 64/415 died (15%) [p=0.036 comparing pre-COVID vs second wave; p=0.013 comparing the first and second wave]. In the pre-COVID era, 27% of patients were re-admitted within 60 days. By contrast 24% were admitted within 60 days during the first COVID wave and 19% during the second COVID wave (overall p=0.04). Post-hoc analysis showed there was significantly lower readmission between pre-COVID era and the 2nd wave. (p=0.015) [Table 1]. Conclusion The number of consecutive episodes of HF admissions has increased compared with the pre-COVID era. There were no changes in mortality between the pre-COVID era and the first wave however there was a statistically significant increase in mortality with the second wave. Conflict of Interest None 120 AUTOMATED DEVICE-HEART FAILURE AUDIT TOOLS IDENTIFY HIGH-RISK SUB-OPTIMALLY MANAGED HF PATIENTS Aman Sanghera, Fozia Ahmed, Angela Sharpe, Cameron Ashraf. Manchester Royal Infirmary, Manchester Heart Centre, Oxford Road, Manchester, GTM M13 9WL, United Kingdom; Manchester Royal Infirmary; Medtronic Limited; University of Manchester 10.1136/heartjnl-2022-BCS.120 Introduction Chronic heart failure (HF) guidelines advocate that all patients with HF should undergo clinical assessment, at least 6-monthly for those who are stable, or more frequently if the clinical condition has changed. Despite this, many patients with less than optimally managed HF are not known to specialist HF services. Cardiac implantable electronic devices (CIEDs), often used in the treatment of HF can also be used to identify patients who are unstable or sub-optimally managed. The validated TriageHF algorithm in enabled CIEDs combines multi-parametric data (Table 1) to stratify patients as Abstract 119 Table 1 Abstracts A90 Heart 2022;108(Suppl 1):A1–A184 on Jne 2, 2023 by gest. P rocted by coright. httpeart.bm jcom / H ert: frst pulished as 10.113artjnl-2022-B C S .18 on 6 Jne 222. D ow nladed fom

123 Long-Term High-Frequency (10 kHz) Spinal Cord Stimulation in Painful Diabetic Neuropathy - A Randomized Controlled Trial

Abstract: INTRODUCTION: World Health Organization estimates 422 million people with diabetes globally and approximately 20% with painful diabetic neuropathy (PDN). Current treatment options are ineffective for many patients; however, previous results suggest high-frequency (10 kHz) spinal cord stimulation (SCS) relieves pain and may improve sensation in patients with refractory symptoms. METHODS: Randomization of 216 patients assigned 1:1 to 10 kHz SCS (Nevro Corp.) combined with conventional medical management (CMM) or CMM alone. Patients had PDN symptoms ≥12 months, lower limb pain ≥5 cm (10 cm visual analog scale), and hemoglobin A1c ≤10%. Outcomes include pain, interference with daily activities and sleep, and neurological examination. Patients could opt to crossover to the other treatment arm at 6 months. RESULTS: At 6 months, 86% of patients in the 10 kHz SCS group were responders with at least 50% pain relief. They reported reduced pain interference with daily activities and improvements in sleep. None of the patients in the 10 kHz SCS group chose to crossover to CMM at 6 months. Treatment benefits were sustained through 12 months. A majority of patients treated with 10 kHz SCS were noted to have improvement on neurological examination. Participants in the CMM group experienced no change in pain levels, pain interference with daily activities, or sleep quality over 6 months. Eighty-two percent opted to crossover to 10 kHz SCS at 6 months. Results post-crossover were similar to those in patients originally randomized to 10 kHz SCS: 84% responders as well as reduced pain interference with daily activities, improvements in sleep, and a majority with observed improvements on neurological examination. CONCLUSION: This is the largest RCT to-date of SCS management in PDN. Substantial improvements with high-frequency (10kHz) SCS were sustained over 12 months and support this treatment for PDN patients with refractory symptoms.

Systematic Review to Identify Predictors of Treatment Response to Neuromodulation in Patients With Neuropathic Pain-Protocol.

Abstract: 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. Spinal cord stimulation (SCS) is an effective treatment for neuropathic pain, although 30% to 40% of patients fail to achieve acceptable levels of pain relief. There are currently no objective methods to predict the success of SCS to treat neuropathic pain, and therefore, it is important to understand which patient factors may be predictive of a lack of response to SCS, to inform future patient treatment options. This study proposes a protocol for a systematic review and meta-analysis of published studies to examine these predictive factors.Several bibliographic databases will be searched to identify relevant studies published since 2012 that provide data on patient characteristics (eg, age, gender, pain severity) as predictors of SCS outcomes of pain, function, and health-related quality of life. Two independent reviewers will screen citations; data will be extracted after full-text screening. Risk of bias will be assessed using the Quality In Prognosis Studies tool.A formal quantitative synthesis is planned in which data from studies with the same predictive factors are available; this will be considered for pooling into separate meta-analyses. In cases of high heterogeneity or inconsistency in the data, subgroup analysis will be conducted.This study seeks to provide a contemporary review of patient predictors of success of neuromodulation for neuropathic pain. We anticipate that findings may guide the use of neuromodulation in patient subgroups and the design and reporting of future clinical studies in this field.

Indirect Comparison of 10 kHz Spinal Cord Stimulation (SCS) versus Traditional Low-Frequency SCS for the Treatment of Painful Diabetic Neuropathy: A Systematic Review of Randomized Controlled Trials

Abstract: Spinal cord stimulation (SCS) is increasingly used to treat painful diabetic neuropathy (PDN). At the time of a recent meta-analysis in this field, data were only available from randomized controlled trials (RCTs) of traditional low-frequency SCS (LF-SCS). However, outcomes from high-frequency 10 kHz SCS treatment are now available. Our study aimed to systematically review the contemporary evidence for SCS in patients with lower limb pain due to PDN and include an indirect comparison of the high- and low-frequency modalities. We searched the PubMed/CENTRAL databases up to 18 August 2022, for peer-reviewed RCTs of SCS that enrolled PDN patients with lower limb pain symptoms. The quality of the evidence was assessed with the Cochrane Risk of Bias tool. Using SCS treatment arm data from the RCTs, we indirectly compared the absolute treatment effect of 10 kHz SCS and LF-SCS. Results are presented in tables and forest plots. This systematic review was reported according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) 2020 guidelines. Three RCTs met our eligibility criteria, including the recent 10 kHz SCS RCT (N = 216, 90 implanted) and 2 others that examined LF-SCS (N = 36, 17 implanted; N = 60, 37 implanted). Our analysis of 6-month data found clinically meaningful pain relief with each SCS modality. However, significantly greater pain reduction was identified for 10 kHz SCS over LF-SCS: average pain reduction in the 10 kHz SCS cohort was 73.7% compared with 47.5% in the pooled LF-SCS group (p < 0.0001). In the permanent implant subset, the 50% pain reduction responder rate was 83.3% in the 10 kHz SCS cohort versus 63.0% in the pooled LF-SCS group (p = 0.0072). The overall risk of bias of each included RCT was deemed high, mainly due to the absence of patient blinding. Our analysis indicates that paresthesia-free 10 kHz SCS can provide superior pain relief and responder rate over LF-SCS for managing PDN patients refractory to conventional medical management.

6 Exercise-based cardiac rehabilitation for coronary heart disease – an updated cochrane systematic review and meta-analysis

Abstract:

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 CR for CHD.

Methods

Database and trial registry searches were conducted to September 2020, seeking RCTs of exercise-based interventions with ≥6 months’ follow-up, compared with no exercise control for adults with myocardial infarction (MI), angina pectoris, or following coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI). Study outcomes (mortality, recurrent clinical events, health-related quality of life (HRQoL) and cost-effectiveness) were pooled using random-effects meta-analysis. Meta-regression was used to examine effect modification. Study quality was assessed using the Cochrane risk of bias (ROB) tool.

Results

A total of 85 RCTs in 23,430 participants with median 12 months follow-up were included. Overall, exercise-based CR was associated with risk reductions in cardiovascular mortality (RR: 0.74, 95%CI: 0.64 to 0.86, number needed to treat [NNT]: 129), hospitalisations (RR: 0.77, 95%CI: 0.67 to 0.89, NNT: 81), and MI (RR: 0.82, 95%CI: 0.70 to 0.96, NNT: 223). Increased HRQoL with CR participation and cost-effectiveness were demonstrated. There was no evidence for risk reductions in overall mortality (RR: 0.96, 95%CI: 0.89 to 1.04) or CABG (RR: 0.96, 95%CI: 0.80 to 1.15). No differential effects were found across different patient groups, CR delivery models, dose, follow-up, or ROB.

Conclusion

This review confirms participation in exercise-based CR by patients with CHD reduces cardiovascular mortality, recurrent cardiac events, and hospitalisations and provides additional evidence supporting the improvement in HRQoL and the cost-effectiveness of CR.

Involving unpaid carers in a home-based self-management intervention for patients living with heart failure (REACH-HF): a quantitative analysis of the impact on patient and carer outcomes. 18th WFOT Congress

Abstract: with heart failure (HF) upon for support with HF self-management. A meta-analysis indicated no in the outcomes of patients with when involved in self-management to address this with a secondary analysis combining two randomised controlled trials (RCTs) of a home-based self-management intervention:

Performance of the imPulse device for the detection of atrial fibrillation in hospital settings

Abstract: 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 minimizing need for follow-up 12-lead electrocardiogram (ECGs).To assess the diagnostic performance of the Plessey imPulse lead I ECG device compared with a 12-lead ECG in detecting AF.Cross-sectional diagnostic accuracy study. Participants underwent simultaneous 12-lead ECG and imPulse device recordings. The imPulse device reports AF to be "probable," "possible," "unlikely," or "uncontrolled AF unlikely." imPulse and ECG reference results were cross-tabulated; sensitivity, specificity, positive/negative predictive values, and positive/negative likelihood ratios with 95% confidence interval (CI) were estimated based on different imPulse device report categorizations and heart rate subgroups.A total of 217 participants were recruited (mean age 70.2 [standard deviation 12.7]), 56% male, 57% outpatients, 43% inpatients) and 199 were included in analyses. AF was diagnosed on ECG for 41 of 199 (20.6%) participants and reported by imPulse as possible, probable, or uncontrolled AF unlikely present for 49 of 199 (24.6%). Sensitivity and specificity for imPulse detection of possible, probable, or uncontrolled AF unlikely vs unlikely, compared with ECG, were 80.5% (95% CI, 65.1%-91.2%) and 89.9% (84.1%-94.1%), respectively. When probable or uncontrolled AF unlikely were compared vs possible or unlikely AF, sensitivity and specificity were 63.4% (46.9%-77.9%) and 98.1% (94.6%-99.6%), respectively.The imPulse device has moderate sensitivity and good specificity compared with ECG AF detection in a hospital setting.

O052 / #884 10-khz spinal cord stimulation is a durable treatment for painful diabetic neuropathy: long-term multicenter randomized controlled trial results

Abstract: Approximately 6 million US adults are living with painful diabetic neuropathy (PDN) and many find conventional treatments ineffective.1-3 The 6-month published data of the prospective, multicenter, randomized, controlled trial (SENZA-PDN) demonstrated 10 kHz spinal cord stimulation (SCS) substantially relieves pain and may improve sensation in patients with refractory symptoms.4

17 Factors affecting implementation of home-based cardiac rehabilitation programme for patients with heart failure in four NHS sites

Abstract: BackgroundThere 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.AimThe study aimed to evaluate the process of implementation in real-world clinical practice by using data generated at four NHS Beacon Sites from England and Northern Ireland which were setup to offer a novel home-based programme – the REACH-HF programme – to 200 patients.MethodsWe used in-depth semi-structured interviews and an online survey. Interviews were conducted with the Beacon Site staff – these were identified using opportunity and snowball sampling. The online survey was subsequently presented to NHS staff who took part in online REACH-HF training during the COVID-19 pandemic. Normalisation Process Theory was used as a framework to guide data collection and analysis.ResultsWe interviewed 17 healthcare professionals working at the Beacon Sites and 17 survey responses were received (20% response rate). We identified a large number of general barriers and enablers to implementation and a smaller number of site-specific factors. The identified barriers and enablers included a lack of resources, a lack of commissioning, having interest in heart failure and working closely with the heart failure team. Different implementation contexts (urban/rural) and factors outside the healthcare team/system (quality of the REACH-HF training, the COVID-19 pandemic) were observed to negatively or positively impact the implementation process.ConclusionThe identified factors were translated into practical solutions. Following consultation with the Beacon Sites we created the REACH-HF Service Delivery Guide, which is now published on the NICE Shared Learning website. The guide is a useful tool that can be used by cardiac rehabilitation services wishing to introduce the REACH-HF programme into routine NHS practice.

ID:16055 Long-Term High-Frequency (10kHz) Spinal Cord Stimulation in Painful Diabetic Neuropathy - A Randomized Controlled Trial

Abstract: World Health Organization estimates 422 million people with diabetes globally and approximately 20% with painful diabetic neuropathy (PDN). Current treatment options are ineffective for many patients; however, previous results suggest high-frequency (10kHz) spinal cord stimulation (SCS) relieves pain and may improve sensation in patients with refractory symptoms.