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AIM: 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 fibrillation (AF). METHODS AND RESULT: CENTRAL, MEDLINE, Embase, PsycINFO and CINAHL databases were searched from January 2009 to July 2022 for randomised controlled trials of psychological interventions versus controls in adults with CHD, HF or AF. Twenty-one studies (n = 2591) were assessed using random-effects models. We found psychological interventions reduced depression (standardised mean difference [SMD] -0.36; 95% confidence interval [CI] -0.65 to -0.06; P = 0.02), anxiety (SMD -0.57; 95% CI -0.96 to -0.18; P = 0.004), and improved mental health-related quality of life (HRQoL) (SMD 0.63, 95% CI 0.01 to 1.26; P = 0.05) (follow-up 6-12 months), but not physical health-related quality of life, all-cause mortality or major adverse cardiovascular events compared with controls. High heterogeneity was present across meta-analyses. Meta-regression analysis showed that psychological interventions designed to target anxiety, were more effective than non-targeted interventions. CONCLUSION: This review found that psychological interventions improved depression, anxiety and mental HRQoL, with those targeting anxiety to show most benefit. Given the statistical heterogeneity, the precise magnitude of effects remains uncertain. Increasing use of multifactorial psychological interventions shows promise for incorporating patient needs and preferences. Investigation of those at high risk of poor outcomes, comparison of intervention components and those with AF is warranted.
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BACKGROUND AND OBJECTIVE: The minimum sample size for multistakeholder Delphi surveys remains understudied. Drawing from three large international multistakeholder Delphi surveys, this study aimed to: 1) investigate the effect of increasing sample size on replicability of results; 2) assess whether the level of replicability of results differed with participant characteristics: for example, gender, age, and profession. METHODS: We used data from Delphi surveys to develop guidance for improved reporting of health-care intervention trials: SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) extension for surrogate end points (n = 175, 22 items rated); CONSORT-SPI [CONSORT extension for Social and Psychological Interventions] (n = 333, 77 items rated); and core outcome set for burn care (n = 553, 88 items rated). Resampling with replacement was used to draw random subsamples from the participant data set in each of the three surveys. For each subsample, the median value of all rated survey items was calculated and compared to the medians from the full participant data set. The median number (and interquartile range) of medians replicated was used to calculate the percentage replicability (and variability). High replicability was defined as ≥80% and moderate as 60% and <80% RESULTS: The average median replicability (variability) as a percentage of total number of items rated from the three datasets was 81% (10%) at a sample size of 60. In one of the datasets (CONSORT-SPI), a ≥80% replicability was reached at a sample size of 80. On average, increasing the sample size from 80 to 160 increased the replicability of results by a further 3% and reduced variability by 1%. For subgroup analysis based on participant characteristics (eg, gender, age, professional role), using resampled samples of 20 to 100 showed that a sample size of 20 to 30 resulted to moderate replicability levels of 64% to 77%. CONCLUSION: We found that a minimum sample size of 60-80 participants in multistakeholder Delphi surveys provides a high level of replicability (≥80%) in the results. For Delphi studies limited to individual stakeholder groups (such as researchers, clinicians, patients), a sample size of 20 to 30 per group may be sufficient.
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Biomarcadores , Lista de Verificación , Ensayos Clínicos Controlados Aleatorios como Asunto , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Biomarcadores/sangre , Proyectos de Investigación/normas , Protocolos de Ensayos Clínicos como AsuntoRESUMEN
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 to identify MLTCs clusters in different age groups in three cohorts: Secure Anonymised Information Linkage Databank (SAIL) (n = 1,825,289), UK Biobank (n = 502,363), and the UK Household Longitudinal Study (UKHLS) (n = 49,186). Incidence rate ratios (IRR) for MLTC clusters were computed for: all-cause mortality, hospitalisations, and general practice (GP) use over 10 years, using <2 MLTCs as reference. Information on health outcomes and service use were extracted for a ten year follow up period (between 01st Jan 2010 and 31st Dec 2019 for UK Biobank and UKHLS, and between 01st Jan 2011 and 31st Dec 2020 for SAIL). Findings: Clustering MLTCs produced largely similar results across different age groups and cohorts. MLTC clusters had distinct associations with health outcomes and service use after accounting for LTC counts, in fully adjusted models. The largest associations with mortality, hospitalisations and GP use in SAIL were observed for the "Pain+" cluster in the age-group 18-36 years (mortality IRR = 4.47, hospitalisation IRR = 1.84; GP use IRR = 2.87) and the "Hypertension, Diabetes & Heart disease" cluster in the age-group 37-54 years (mortality IRR = 4.52, hospitalisation IRR = 1.53, GP use IRR = 2.36). In UK Biobank, the "Cancer, Thyroid disease & Rheumatoid arthritis" cluster in the age group 37-54 years had the largest association with mortality (IRR = 2.47). Cardiometabolic clusters across all age groups, pain/mental health clusters in younger groups, and cancer and pulmonary related clusters in older age groups had higher risk for all outcomes. In UKHLS, MLTC clusters were not significantly associated with higher risk of adverse outcomes, except for the hospitalisation in the age-group 18-36 years. Interpretation: Personalising care around MLTC clusters that have higher risk of adverse outcomes may have important implications for practice (in relation to secondary prevention), policy (with allocation of health care resources), and research (intervention development and targeting), for people living with MLTCs. Funding: This study was funded by the National Institute for Health and Care Research (NIHR; Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (multimorbidity)-NIHR202020).
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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 to October 2023 for SRs assessing health outcomes (mortality, hospitalisation, exercise capacity, disability, frailty, health-related quality of life (HRQoL), and physical activity) related to exercise-based interventions in adults (aged >18 years) diagnosed with one of 45 LTCs. Methodological quality was assessed using AMSTAR-2. International Prospective Resister of Systematic Reviews (PROSPERO) ID: CRD42022319214. Findings: Forty-two SRs plus three supplementary RCTs were included, providing 990 RCTs in 936,825 people across 39 LTCs. No evidence was identified for six LTCs. Predominant outcome domains were HRQoL (82% of SRs/RCTs) and exercise capacity (66%); whereas disability, mortality, physical activity, and hospitalisation were less frequently reported (≤25%). Evidence supporting exercise-based interventions was identified in 25 LTCs, was unclear for 13 LTCs, and for one LTC suggested no effect. No SRs considered multimorbidity in the delivery of exercise. Methodological quality varied: critically-low (33%), low (26%), moderate (26%), and high (12%). Interpretation: Exercise-based interventions improve HRQoL and exercise capacity across numerous LTCs. Key evidence gaps included limited mortality and hospitalisation data and consideration of multimorbidity impact on exercise-based interventions. Funding: This study was funded by the National Institute for Health and Care Research (NIHR; Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (multimorbidity)-NIHR202020).
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OBJECTIVE: Short-term outcomes of deep brain stimulation of the anterior nucleus of the thalamus (ANT-DBS) were reported for people with drug-resistant focal epilepsy (PwE). Because long-term data are still scarce, the Medtronic Registry for Epilepsy (MORE) evaluated clinical routine application of ANT-DBS. METHODS: In this multicenter registry, PwE with ANT-DBS were followed up for safety, efficacy, and battery longevity. Follow-up ended after 5 years or upon study closure. Clinical characteristics and stimulation settings were compared between PwE with no benefit, improvers, and responders, that is, PwE with average monthly seizure frequency reduction rates of ≥50%. RESULTS: Of 170 eligible PwE, 104, 62, and 49 completed the 3-, 4-, and 5-year follow-up, respectively. Most discontinuations (68%) were due to planned study closure as follow-up beyond 2 years was optional. The 5-year follow-up cohort had a median seizure frequency reduction from 16 per month at baseline to 7.9 per month at 5-year follow-up (p < .001), with most-pronounced effects on focal-to-bilateral tonic-clonic seizures (n = 15, 77% reduction, p = .008). At last follow-up (median 3.5 years), 41% (69/170) of PwE were responders. Unifocal epilepsy (p = .035) and a negative history of epilepsy surgery (p = .002) were associated with larger average monthly seizure frequency reductions. Stimulation settings did not differ between response groups. In 179 implanted PwE, DBS-related adverse events (AEs, n = 225) and serious AEs (n = 75) included deterioration in epilepsy or seizure frequency/severity/type (33; 14 serious), memory/cognitive impairment (29; 3 serious), and depression (13; 4 serious). Five deaths occurred (none were ANT-DBS related). Most AEs (76.3%) manifested within the first 2 years after implantation. Activa PC depletion (n = 37) occurred on average after 45 months. SIGNIFICANCE: MORE provides further evidence for the long-term application of ANT-DBS in clinical routine practice. Although clinical benefits increased over time, side effects occurred mainly during the first 2 years. Identified outcome modifiers can help inform PwE selection and management.
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Núcleos Talámicos Anteriores , Estimulación Encefálica Profunda , Epilepsia Refractaria , Sistema de Registros , Humanos , Estimulación Encefálica Profunda/métodos , Estimulación Encefálica Profunda/efectos adversos , Femenino , Masculino , Adulto , Persona de Mediana Edad , Epilepsia Refractaria/terapia , Resultado del Tratamiento , Europa (Continente)/epidemiología , Adulto Joven , Estudios de Seguimiento , Adolescente , AncianoRESUMEN
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 countries (LMICs). Bibliographic databases were searched from 2000 to October 2022. This review involved five stages: (i) definition of the research question(s); (ii) identifying relevant studies; (iii) study selection; (iv) data charting; and (v) data synthesis. Extraction included an assessment of the: rationale for adaptation; stages and levels of adaptation; use of theoretical frameworks, and quality of reporting using a checklist based on the 2021 ADAPT guidance. Twenty-five studies were included from across 21 LTCs and a range of complex interventions. The majority (16 studies) focused on macro (national or international) level interventions. The rationale for adaptation included intervention transfer across geographical settings [high-income country (HIC) to LMIC: six studies, one HIC to another: eight studies, one LMIC to another: two studies], or transfer across socio-economic/racial groups (five studies), or transfer between different health settings within a single country (one study). Overall, studies were judged to be of moderate reporting quality (median score 23, maximum 46), and typically focused on early stages of adaptation (identification and development) with limited outcome evaluation or implementation assessment of the adapted version of the intervention. Improved reporting of the adaptation for complex interventions targeted at LTCs is needed. Development of future adaptation methods guidance needs to consider the needs and priorities of the LMIC context.
Limited finance and human capacity may reduce access to new treatments for people with long-term conditions. This is especially true in low- and middle-income countries. One solution is to transfer treatments developed in one place for use in other areas. This paper provides a current summary of international research on adapting treatments. We used a checklist to assess study reporting quality, based on published advice. Our findings showed the need for better conduct and reporting of adaptation. Future guidance should consider the specific needs of low- and middle-income countries.
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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 protocol for a randomised trial to assess the feasibility and acceptability of the PERFORM intervention, study design and processes. METHODS AND ANALYSIS: A multicentre, parallel two-group randomised trial with individual 2:1 allocation to the PERFORM exercise-based intervention plus usual care (intervention) or usual care alone (control). The primary outcome of this feasibility trial will be to assess whether prespecified progression criteria (recruitment, retention, intervention adherence) are met to progress to the full randomised trial. The trial will be conducted across three UK sites and 60 people with MLTCs, defined as two or more LTCs, with at least one having evidence of the beneficial effect of exercise. The PERFORM intervention comprises an 8-week (twice a week for 6 weeks and once a week for 2 weeks) supervised rehabilitation programme of personalised exercise training and self-management education delivered by trained healthcare professionals followed by two maintenance sessions. Trial participants will be recruited over a 4.5-month period, and outcomes assessed at baseline (prerandomisation) and 3 months postrandomisation and include health-related quality of life, psychological well-being, symptom burden, frailty, exercise capacity, physical activity, sleep, cognition and serious adverse events. A mixed-methods process evaluation will assess acceptability, feasibility and fidelity of intervention delivery and feasibility of trial processes. An economic evaluation will assess the feasibility of data collection and estimate the costs of the PERFORM intervention. ETHICS AND DISSEMINATION: The trial has been given favourable opinion by the West Midlands, Edgbaston Research Ethics Service (Ref: 23/WM/0057). Participants will be asked to give full, written consent to take part by trained researchers. Findings will be disseminated via journals, presentations and targeted communications to clinicians, commissioners, service users and patients and the public. TRIAL REGISTRATION NUMBER: ISRCTN68786622. PROTOCOL VERSION: 2.0 (16 May 2023).
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Calidad de Vida , Automanejo , Humanos , Estudios de Factibilidad , Terapia por Ejercicio , Ejercicio Físico , Análisis Costo-Beneficio , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como AsuntoRESUMEN
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 interventions are developed and delivered by psychologists or specifically trained healthcare workers and commonly include cognitive behavioural therapies and mindfulness-based stress reduction. They have been shown to reduce depression and anxiety in the general population, though the exact mechanism of action is not well understood. Further, their effects on psychological and clinical outcomes in patients with CHD, HF or AF are unclear. OBJECTIVES: To assess the effects of psychological interventions (alone, or with cardiac rehabilitation or pharmacotherapy, or both) in adults who have a diagnosis of CHD, HF or AF, compared to no psychological intervention, on psychological and clinical outcomes. SEARCH METHODS: We searched the CENTRAL, MEDLINE, Embase, PsycINFO and CINAHL databases from 2009 to July 2022. We also searched three clinical trials registers in September 2020, and checked the reference lists of included studies. No language restrictions were applied. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing psychological interventions with no psychological intervention for a minimum of six months follow-up in adults aged over 18 years with a clinical diagnosis of CHD, HF or AF, with or without depression or anxiety. Studies had to report on either depression or anxiety or both. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were depression and anxiety, and our secondary outcomes of interest were HRQoL mental and physical components, all-cause mortality and major adverse cardiovascular events (MACE). We used GRADE to assess the certainty of evidence for each outcome. MAIN RESULTS: Twenty-one studies (2591 participants) met our inclusion criteria. Sixteen studies included people with CHD, five with HF and none with AF. Study sample sizes ranged from 29 to 430. Twenty and 17 studies reported the primary outcomes of depression and anxiety, respectively. Despite the high heterogeneity and variation, we decided to pool the studies using a random-effects model, recognising that the model does not eliminate heterogeneity and findings should be interpreted cautiously. We found that psychological interventions probably have a moderate effect on reducing depression (standardised mean difference (SMD) -0.36, 95% confidence interval (CI) -0.65 to -0.06; 20 studies, 2531 participants; moderate-certainty evidence) and anxiety (SMD -0.57, 95% CI -0.96 to -0.18; 17 studies, 2235 participants; moderate-certainty evidence), compared to no psychological intervention. Psychological interventions may have little to no effect on HRQoL physical component summary scores (PCS) (SMD 0.48, 95% CI -0.02 to 0.98; 12 studies, 1454 participants; low-certainty evidence), but may have a moderate effect on improving HRQoL mental component summary scores (MCS) (SMD 0.63, 95% CI 0.01 to 1.26; 12 studies, 1454 participants; low-certainty evidence), compared to no psychological intervention. Psychological interventions probably have little to no effect on all-cause mortality (risk ratio (RR) 0.81, 95% CI 0.39 to 1.69; 3 studies, 615 participants; moderate-certainty evidence) and may have little to no effect on MACE (RR 1.22, 95% CI 0.77 to 1.92; 4 studies, 450 participants; low-certainty evidence), compared to no psychological intervention. AUTHORS' CONCLUSIONS: Current evidence suggests that psychological interventions for depression and anxiety probably result in a moderate reduction in depression and anxiety and may result in a moderate improvement in HRQoL MCS, compared to no intervention. However, they may have little to no effect on HRQoL PCS and MACE, and probably do not reduce mortality (all-cause) in adults who have a diagnosis of CHD or HF, compared with no psychological intervention. There was moderate to substantial heterogeneity identified across studies. Thus, evidence of treatment effects on these outcomes warrants careful interpretation. As there were no studies of psychological interventions for patients with AF included in our review, this is a gap that needs to be addressed in future studies, particularly in view of the rapid growth of research on management of AF. Studies investigating cost-effectiveness, return to work and cardiovascular morbidity (revascularisation) are also needed to better understand the benefits of psychological interventions in populations with heart disease.
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Fibrilación Atrial , Enfermedad Coronaria , Insuficiencia Cardíaca , Adulto , Humanos , Ansiedad/terapia , Ansiedad/psicología , Fibrilación Atrial/terapia , Depresión/terapia , Depresión/psicología , Insuficiencia Cardíaca/terapia , Intervención Psicosocial , Calidad de VidaRESUMEN
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 effects measured using surrogate markers and clinical outcomes in nononcologic chronic diseases. Data sources: The Food and Drug Administration (FDA) Adult Surrogate Endpoint Table and MEDLINE from inception to March 19, 2023. Study Selection: Three reviewers selected meta-analyses of clinical trials; meta-analyses of observational studies were excluded. Data Extraction and Synthesis: Two reviewers extracted correlation coefficients, coefficients of determination, slopes, effect estimates, or results from meta-regression analyses between surrogate markers and clinical outcomes. Main Outcomes and Measures: Correlation coefficient or coefficient of determination, when reported, was classified as high strength (r ≥ 0.85 or R2 ≥ 0.72); primary findings were otherwise summarized. Results: Thirty-seven surrogate markers listed in FDA's table and used as primary end points in clinical trials across 32 unique nononcologic chronic diseases were included. For 22 (59%) surrogate markers (21 chronic diseases), no eligible meta-analysis was identified. For 15 (41%) surrogate markers (14 chronic diseases), at least 1 meta-analysis was identified, 54 in total (median per surrogate marker, 2.5; IQR, 1.3-6.0); among these, median number of trials and patients meta-analyzed was 18.5 (IQR, 12.0-43.0) and 90â¯056 (IQR, 20â¯109-170â¯014), respectively. The 54 meta-analyses reported 109 unique surrogate marker-clinical outcome pairs: 59 (54%) reported at least 1 r or R2, 10 (17%) of which reported at least 1 classified as high strength, whereas 50 (46%) reported slopes, effect estimates, or results of meta-regression analyses only, 26 (52%) of which reported at least 1 statistically significant result. Conclusions and Relevance: Most surrogate markers used as primary end points in clinical trials to support FDA approval of drugs treating nononcologic chronic diseases lacked high-strength evidence of associations with clinical outcomes from published meta-analyses.
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Biomarcadores , Enfermedad Crónica , Aprobación de Drogas , Humanos , Biomarcadores/análisis , Enfermedad Crónica/tratamiento farmacológico , Ensayos Clínicos como Asunto , Metaanálisis como Asunto , Resultado del Tratamiento , Estados Unidos , Aprobación de Drogas/métodosRESUMEN
BACKGROUND: People with heart failure experience substantial disease burden that includes low exercise tolerance, poor health-related quality of life (HRQoL), increased risk of mortality and hospital admission, and high healthcare costs. The previous 2018 Cochrane review reported that exercise-based cardiac rehabilitation (ExCR) compared to no exercise control shows improvement in HRQoL and hospital admission amongst people with heart failure, as well as possible reduction in mortality over the longer term, and that these reductions appear to be consistent across patient and programme characteristics. Limitations noted by the authors of this previous Cochrane review include the following: (1) most trials were undertaken in patients with heart failure with reduced (< 45%) ejection fraction (HFrEF), and women, older people, and those with heart failure with preserved (≥ 45%) ejection fraction (HFpEF) were under-represented; and (2) most trials were undertaken in a hospital or centre-based setting. OBJECTIVES: To assess the effects of ExCR on mortality, hospital admission, and health-related quality of life of adults with heart failure. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO and Web of Science without language restriction on 13 December 2021. We also checked the bibliographies of included studies, identified relevant systematic reviews, and two clinical trials registers. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that compared ExCR interventions (either exercise only or exercise as part of a comprehensive cardiac rehabilitation) with a follow-up of six months or longer versus a no-exercise control (e.g. usual medical care). The study population comprised adults (≥ 18 years) with heart failure - either HFrEF or HFpEF. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were all-cause mortality, mortality due to heart failure, all-cause hospital admissions, heart failure-related hospital admissions, and HRQoL. Secondary outcomes were costs and cost-effectiveness. We used GRADE to assess the certainty of the evidence. MAIN RESULTS: We included 60 trials (8728 participants) with a median of six months' follow-up. For this latest update, we identified 16 new trials (2945 new participants), in addition to the previously identified 44 trials (5783 existing participants). Although the existing evidence base predominantly includes patients with HFrEF, with New York Heart Association (NYHA) classes II and III receiving centre-based ExCR programmes, a growing body of trials includes patients with HFpEF with ExCR undertaken in a home-based setting. All included trials employed a usual care comparator with a formal no-exercise intervention as well as a wide range of active comparators, such as education, psychological intervention, or medical management. The overall risk of bias in the included trials was low or unclear, and we mostly downgraded the certainty of evidence of outcomes upon GRADE assessment. There was no evidence of a difference in the short term (up to 12 months' follow-up) in the pooled risk of all-cause mortality when comparing ExCR versus usual care (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.71 to 1.21; absolute effects 5.0% versus 5.8%; 34 trials, 36 comparisons, 3941 participants; low-certainty evidence). Only a few trials reported information on whether participants died due to heart failure. Participation in ExCR versus usual care likely reduced the risk of all-cause hospital admissions (RR 0.69, 95% CI 0.56 to 0.86; absolute effects 15.9% versus 23.8%; 23 trials, 24 comparisons, 2283 participants; moderate-certainty evidence) and heart failure-related hospital admissions (RR 0.82, 95% CI 0.49 to 1.35; absolute effects 5.6% versus 6.4%; 10 trials; 10 comparisons, 911 participants; moderate-certainty evidence) in the short term. Participation in ExCR likely improved short-term HRQoL as measured by the Minnesota Living with Heart Failure (MLWHF) questionnaire (lower scores indicate better HRQoL and a difference of 5 points or more indicates clinical importance; mean difference (MD) -7.39 points, 95% CI -10.30 to -4.77; 21 trials, 22 comparisons, 2699 participants; moderate-certainty evidence). When pooling HRQoL data measured by any questionnaire/scale, we found that ExCR may improve HRQoL in the short term, but the evidence is very uncertain (33 trials, 37 comparisons, 4769 participants; standardised mean difference (SMD) -0.52, 95% CI -0.70 to -0.34; very-low certainty evidence). ExCR effects appeared to be consistent across different models of ExCR delivery: centre- versus home-based, exercise dose, exercise only versus comprehensive programmes, and aerobic training alone versus aerobic plus resistance programmes. AUTHORS' CONCLUSIONS: This updated Cochrane review provides additional randomised evidence (16 trials) to support the conclusions of the previous 2018 version of the review. Compared to no exercise control, whilst there was no evidence of a difference in all-cause mortality in people with heart failure, ExCR participation likely reduces the risk of all-cause hospital admissions and heart failure-related hospital admissions, and may result in important improvements in HRQoL. Importantly, this updated review provides additional evidence supporting the use of alternative modes of ExCR delivery, including home-based and digitally-supported programmes. Future ExCR trials need to focus on the recruitment of traditionally less represented heart failure patient groups including older patients, women, and those with HFpEF.
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Rehabilitación Cardiaca , Insuficiencia Cardíaca , Humanos , Rehabilitación Cardiaca/métodos , Ejercicio Físico , Terapia por Ejercicio , Calidad de VidaRESUMEN
AIMS: Adapting interventions with an existing evidence base offers a more efficient approach than development of 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 United Kingdom for people with heart failure (HF) to the Danish health system - the 'DK:REACH-HF' programme. METHODS AND RESULTS: We followed methodological framework for the conduct and reporting of studies adapting interventions, utilizing documentary analysis, qualitative interviews, stakeholder consultations, and mapping of the Danish policy context. Our study found broad support for the REACH-HF intervention as an alternative to existing centre-based CR. We also identified three key areas of adaptation for the Danish context. First, reduce the word-count of the intervention's resources by linking to existing publicly available CR materials. Second, whilst retaining REACH-HF core components, adapt its content and delivery to reflect differences between Denmark and United Kingdom. Thirdly, to develop a digital version of the intervention. CONCLUSION: Using an evidence-based approach, we successfully adapted the REACH-HF intervention to the context of the Danish healthcare setting, maintaining core components of the original intervention, and developing both a paper based and digital version of the programme material. To inform scaled national implementation of the DK:REACH-HF programme, we seek to undertake a pilot study to test the adapted intervention materials feasibility and acceptability to healthcare practitioners, patients, and their caregivers and confirm the positive impact on the outcomes of HF patients and caregivers.
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BACKGROUND: 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 effectiveness of the addition of the Paradise uRDN System compared with standard of care alone in patients with rHTN from the perspective of the United Kingdom (UK) health care system. METHODS: Using RADIANCE-HTN TRIO trial data, we developed a state-transition model. Baseline risk was calculated using Framingham and Prospective Cardiovascular Münster (PROCAM) risk equations to estimate the long-term cardiovascular risks in patients treated with the Paradise uRDN System, based on the observed systolic BP (SBP) reduction following uRDN. Relative risks sourced from a meta-analysis of randomised controlled trials were then used to project cardiovascular events in patients with baseline SBP ('control' patients); utility and mortality inputs and costs were derived from UK data. Costs and outcomes were discounted at 3.5% per annum. Modelled outcomes were validated against trial meta-analyses and the QRISK3 algorithm and real-world evidence of RDN effectiveness. One-way and probabilistic sensitivity analyses were conducted to assess the uncertainty surrounding the model inputs and sensitivity of the model results to changes in parameter inputs. Results were reported as incremental cost-effectiveness ratios (ICERs). RESULTS: A mean reduction in office SBP of 8.5 mmHg with uRDN resulted in an average improvement in both absolute life-years (LYs) and quality-adjusted life-years (QALYs) gained compared with standard of care alone (0.73 LYs and 0.67 QALYs). The overall base-case ICER with uRDN was estimated at £5600 (6500) per QALY gained (95% confidence interval £5463-£5739 [6341-6661]); modelling demonstrated > 99% probability that the ICER is below the £20,000-£30,000 (23,214-34,821) per QALYs gained willingness-to-pay threshold in the UK. Results were consistent across sensitivity analyses and validation checks. CONCLUSIONS: Endovascular ultrasound RDN with the Paradise system offers patients with rHTN, clinicians, and healthcare systems a cost-effective treatment option alongside antihypertensive medication.