Dwayne Boyers

Systematic reviews of and integrated report on the quantitative, qualitative and economic evidence base for the management of obesity in men

BACKGROUND Obesity increases the risk of many serious illnesses such as coronary heart disease, type 2 diabetes and osteoarthritis. More men than women are overweight or obese in the UK but men are less likely to perceive their weight as a problem and less likely to engage with weight-loss services. OBJECTIVE The aim of this study was to systematically review evidence-based management strategies for treating obesity in men and investigate how to engage men in obesity services by integrating the quantitative, qualitative and health economic evidence base. DATA SOURCES Electronic databases including MEDLINE, EMBASE, PsycINFO, the Cochrane Central Register of Controlled Trials, the Database of Abstracts of Reviews of Effects and the NHS Economic Evaluation Database were searched from inception to January 2012, with a limited update search in July 2012. Subject-specific websites, reference lists and professional health-care and commercial organisations were also consulted. REVIEW METHODS Six systematic reviews were conducted to consider the clinical effectiveness, cost-effectiveness and qualitative evidence on interventions for treating obesity in men, and men in contrast to women, and the effectiveness of interventions to engage men in their weight reduction. Randomised controlled trials (RCTs) with follow-up data of at least 1 year, or any study design and length of follow-up for UK studies, were included. Qualitative and mixed-method studies linked to RCTs and non-randomised intervention studies, and UK-based, men-only qualitative studies not linked to interventions were included. One reviewer extracted data from the included studies and a second reviewer checked data for omissions or inaccuracies. Two reviewers carried out quality assessment. We undertook meta-analysis of quantitative data and a realist approach to integrating the qualitative and quantitative evidence synthesis. RESULTS From a total of 12,764 titles reviewed, 33 RCTs with 12 linked reports, 24 non-randomised reports, five economic evaluations with two linked reports, and 22 qualitative studies were included. Men were more likely than women to benefit if physical activity was part of a weight-loss programme. Reducing diets tended to produce more favourable weight loss than physical activity alone (mean weight change after 1 year from a reducing diet compared with an exercise programme -3.2 kg, 95% CI -4.8 kg to -1.6 kg). The type of reducing diet did not affect long-term weight loss. A reducing diet plus physical activity and behaviour change gave the most effective results. Low-fat reducing diets, some with meal replacements, combined with physical activity and behaviour change training gave the most effective long-term weight change in men [-5.2 kg (standard error 0.2 kg) after 4 years]. Such trials may prevent type 2 diabetes in men and improve erectile dysfunction. Although fewer men joined weight-loss programmes, once recruited they were less likely to drop out than women (difference 11%, 95% CI 8% to 14%). The perception of having a health problem (e.g. being defined as obese by a health professional), the impact of weight loss on health problems and desire to improve personal appearance without looking too thin were motivators for weight loss amongst men. The key components differ from those found for women, with men preferring more factual information on how to lose weight and more emphasis on physical activity programmes. Interventions delivered in social settings were preferred to those delivered in health-care settings. Group-based programmes showed benefits by facilitating support for men with similar health problems, and some individual tailoring of advice assisted weight loss in some studies. Generally, men preferred interventions that were individualised, fact-based and flexible, which used business-like language and which included simple to understand information. Preferences for men-only versus mixed-sex weight-loss group programmes were divided. In terms of context, programmes which were cited in a sporting context where participants have a strong sense of affiliation showed low drop out rates and high satisfaction. Although some men preferred weight-loss programmes delivered in an NHS context, the evidence comparing NHS and commercial programmes for men was unclear. The effect of family and friends on participants in weight-loss programmes was inconsistent in the evidence reviewed - benefits were shown in some cases, but the social role of food in maintaining relationships may also act as a barrier to weight loss. Evidence on the economics of managing obesity in men was limited and heterogeneous. LIMITATIONS The main limitations were the limited quantity and quality of the evidence base and narrow outcome reporting, particularly for men from disadvantaged and minority groups. Few of the studies were undertaken in the UK. CONCLUSIONS Weight reduction for men is best achieved and maintained with the combination of a reducing diet, physical activity advice or a physical activity programme, and behaviour change techniques. Tailoring interventions and settings for men may enhance effectiveness, though further research is needed to better understand the influence of context and content. Future studies should include cost-effectiveness analyses in the UK setting. FUNDING This project was funded by the NIHR Health Technology Assessment programme.

Eltrombopag for the treatment of chronic immune or idiopathic thrombocytopenic purpura : A NICE single technology appraisal

The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of eltrombopag (GlaxoSmithKline) to submit evidence for the clinical and cost effectiveness of this drug for the treatment of patients with chronic immune or idiopathic thrombocytopenic purpura (ITP), as part of the their Single Technology Appraisal (STA) process. The Aberdeen Technology Assessment Review (TAR) Group, commissioned to act as the evidence review group (ERG), critically reviewed and supplemented the submitted evidence. This paper describes the company submission, the ERG review and NICE’s subsequent decisions.The ERG critically appraised the clinical and cost-effectiveness evidence submitted by the manufacturer, independently searched for relevant literature, conducted a critical appraisal of the submitted economic models and explored the impact of altering some of the key model assumptions as well as combining relevant sensitivity analyses.Three trials were used to inform the safety and efficacy aspects of this submission; however, one high-quality randomized controlled trial (RAISE study) was the principal source of evidence and was used to inform the economic model. Eltrombopag had greater odds of achieving the primary outcome of a platelet count between 50×10^9/L and 400×10^9/L during the 6-month treatment period than placebo (odds ratio [OR] 8.2, 99% CI 3.6, 18.7). In the eltrombopag group, 50/83 (60%) of non-splenectomized patients and 18/49 (37%) of splenectomized patients achieved this outcome. The median duration of response was 10.9 weeks for eltrombopag (splenectomized 6 and non-splenectomized 13.4) compared with 0 for placebo. Eltrombopag patients required less rescue medication and had lower odds of bleeding events for both the splenectomized and the non-splenectomized patients.For a watch-and-rescue strategy of care, the comparator was placebo and the ERG found that substantial reductions in the cost of eltrombopag are needed before the incremental cost per QALY is less than £30 000. There was significant uncertainty, with the incremental cost-effectiveness ratio (ICER) reported varying from £33 561 to £103 500 per QALY (splenectomized) and £39 657 to £150 245 per QALY (non-splenectomized). All costs are presented in £, year 2008 values, as this was the costing year for the manufacturer’s model. Other than bleeding, no adverse events were modelled. In relation to the long-term treatment model, the ERG questioned the robustness of the use of non-randomized non-comparative data. The base-case results restricting the time horizon to 2 years and prescribing eltrombopag as second-line treatment post-rituximab were found to be favourable towards eltrombopag. As rituximab is not a licensed treatment for ITP, the ERG were concerned that its inclusion may not be reflective of clinical practice. None of the treatment sequences resulted in an ICER approaching the recommended threshold of £30 000 per QALY gained.Eltrombopag appears to be a safe treatment for ITP (although long-term follow-up studies are awaited) and has short-term efficacy. However, NICE found based on the evidence submitted and reviewed that there was no robust evidence on the long-term efficacy or cost effectiveness of eltrombopag and a lack of direct evidence for eltrombopag tested against other relevant comparators.

The FEeding Support Team (FEST) randomised, controlled feasibility trial of proactive and reactive telephone support for breastfeeding women living in disadvantaged areas

Objective To assess the feasibility of implementing a dedicated feeding support team on a postnatal ward and pilot the potential effectiveness and cost-effectiveness of team (proactive) and woman-initiated (reactive) telephone support after discharge. Design Randomised controlled trial embedded within a before-and-after study. Participatory approach and mixed-method process evaluation. Setting A postnatal ward in Scotland. Sample Women living in disadvantaged areas initiating breast feeding. Methods Eligible women were recruited to a before-and-after intervention study, a proportion of whom were independently randomised after hospital discharge to intervention: daily proactive and reactive telephone calls for ≤14 days or control: reactive telephone calls ≤ day 14. Intention-to-treat analysis compared the randomised groups on cases with complete outcomes at follow-up. Main outcome measures Primary outcome: any breast feeding at 6–8 weeks assessed by a telephone call from a researcher blind to group allocation. Secondary outcomes: exclusive breast feeding, satisfaction with care, NHS costs and cost per additional woman breast feeding. Results There was no difference in feeding outcomes for women initiating breast feeding before the intervention (n=413) and after (n=388). 69 women were randomised to telephone support: 35 intervention (32 complete cases) and 34 control (26 complete cases). 22 intervention women compared with 12 control women were giving their baby some breast milk (RR 1.49, 95% CI 0.92 to 2.40) and 17 intervention women compared with eight control women were exclusively breast feeding (RR 1.73, 95% CI 0.88 to 3.37) at 6–8 weeks after birth. The incremental cost of providing proactive calls was £87 per additional woman breast feeding and £91 per additional woman exclusively breast feeding at 6–8 weeks; costs were sensitive to service organisation. Conclusions Proactive telephone care delivered by a dedicated feeding team shows promise as a cost-effective intervention for improving breastfeeding outcomes. Integrating the FEeding Support Team (FEST) intervention into routine postnatal care was feasible. Trial registration number ISRCTN27207603. The study protocol and final report are available on request.

Early Surgery versus Initial Conservative Treatment in Patients with Traumatic Intracerebral Hemorrhage (STITCH[Trauma]): The First Randomized Trial.

Abstract Intraparenchymal hemorrhages occur in a proportion of severe traumatic brain injury TBI patients, but the role of surgery in their treatment is unclear. This international multi-center, patient-randomized, parallel-group trial compared early surgery (hematoma evacuation within 12 h of randomization) with initial conservative treatment (subsequent evacuation allowed if deemed necessary). Patients were randomized using an independent randomization service within 48 h of TBI. Patients were eligible if they had no more than two intraparenchymal hemorrhages of 10 mL or more and did not have an extradural or subdural hematoma that required surgery. The primary outcome measure was the traditional dichotomous split of the Glasgow Outcome Scale obtained by postal questionnaires sent directly to patients at 6 months. The trial was halted early by the UK funding agency (NIHR HTA) for failure to recruit sufficient patients from the UK (trial registration: ISRCTN19321911). A total of 170 patients were randomized from 31 of 59 registered centers worldwide. Of 82 patients randomized to early surgery with complete follow-up, 30 (37%) had an unfavorable outcome. Of 85 patients randomized to initial conservative treatment with complete follow-up, 40 (47%) had an unfavorable outcome (odds ratio, 0.65; 95% confidence interval, CI 0.35, 1.21; p=0.17), with an absolute benefit of 10.5% (CI, −4.4–25.3%). There were significantly more deaths in the first 6 months in the initial conservative treatment group (33% vs. 15%; p=0.006). The 10.5% absolute benefit with early surgery was consistent with the initial power calculation. However, with the low sample size resulting from the premature termination, we cannot exclude the possibility that this could be a chance finding. A further trial is required urgently to assess whether this encouraging signal can be confirmed.

Cost-effectiveness of Self-management Methods for the Treatment of Chronic Pain in an Aging Adult Population A Systematic Review of the Literature

Objective:To determine the cost-effectiveness of self-management techniques for older populations (65 and over) with chronic pain and in the absence of such evidence to investigate this question in an aging adult population (average age 60 and over). Methods:Systematic review of randomized controlled trials (RCTs) with cost-effectiveness data and at least 6 months’ follow-up, up to December 2010. Results:No RCT studies reported cost-effectiveness of self-management exclusively in the over 65 age group. Ten RCTs reported participants with an average age of 60 years or over and met all other inclusion criteria. All of these studies measured cost-effectiveness as cost per improvement in primary outcome, 7 of them using the Western Ontario and McMaster Universities Osteoarthritis Index score, of which 6 reported the pain dimension. Six studies reported cost per quality-adjusted life year (QALY)-gained information, with a further 1 reporting EQ-5D. In 7 studies, relative to usual care, self-management was effective, and in the remaining 3 studies, there was no significant difference. Among those reporting cost per QALY-gained results, self-management did not lead to statistically significant QALY gains relative to usual care (with only one exception). Eight studies suggested that the cost of developing and delivering self-management interventions may be partly offset by savings from reduced subsequent health care resource use. Conclusions:Self-management is effective among an aging adult population (mean age over 60) with chronic pain and may be cost-effective when outcomes are measured using the Western Ontario and McMaster Universities Osteoarthritis Index pain score. Cost-effectiveness is less certain when measured using the QALY metric. Uncertainty over conclusions regarding cost-effectiveness exists partly due to lack of information regarding societal willingness to pay for pain improvement. There is a need for large multicentred high-quality RCTs to confirm the findings of this review exclusively among older aged populations, such as those who have already reached the statutory retirement age.

Efficacy and Cost of an Exercise Program for Functionally Impaired Older Patients With Heart Failure A Randomized Controlled Trial

Background—Little is known about the optimum way to deliver exercise to older, functionally impaired patients with heart failure. We tested whether an exercise program tailored to the needs of these patients could improve exercise capacity and quality of life or reduce costs to the National Health Service. Methods and Results—The study design was a parallel-group, single-blind, randomized controlled trial. Patients aged ≥70 years with symptomatic heart failure and left ventricular systolic dysfunction were randomized to either 24 weeks of exercise training or usual care. Six-minute walk distance was the primary outcome; markers of physical function, quality of life, health status, and daily activity were measured at baseline and 8 and 24 weeks. Carer strain and healthcare costs were also recorded. A total of 107 participants were randomized (mean age, 80 years; men, 72 [67%]). Six-minute walk distance did not improve compared to that of the control group at 8 weeks (−16.9 m; 95% CI, −41.8 to 7.9 m; P=0.18) or at 24 weeks (−5.3 m; 95% CI, −32.6 to 22.0 m; P=0.70). For secondary outcomes, only the sit-to-stand test improved significantly at 24 weeks (−6.4 s; 95% CI, −12.2 to 0.6 s; P=0.03); there was no difference in change for the Minnesota Living With Heart Failure score (0.1 points; 95% CI, −0.9 to 1.1 points; P=0.83) at 24 weeks. Carer strain did not decrease at 24 weeks (difference, −0.5 points; 95% CI, −8.3 to 7.3 points; P=0.80), and there was no difference in overall healthcare costs. Conclusions—This exercise intervention did not improve exercise capacity or quality of life in older patients with heart failure and was not cost saving to the National Health Service. Clinical Trial Registration—URL: http://www.controlled-trials.com. Unique identifier: ISRCTN51615566.

Eltrombopag for the treatment of chronic idiopathic (immune) thrombocytopenic purpura (ITP).

This paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of eltrombopag for the treatment of adults with chronic idiopathic (immune) thrombocytopenic purpura (ITP), based on a review of the manufacturers submission (MS) to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal process. ITP is an autoimmune disorder by which antibodies are formed against platelets with annual incidence rates in the UK/USA ranging from 1.13 to 6.62 cases per 100,000 adults. Eltrombopag increases the production of platelets at a rate that outpaces their destruction by the immune system, and has a UK marketing authorisation both for the treatment of adult ITP in splenectomised patients who are refractory to other treatments and as a second-line treatment for adult non-splenectomised patients for whom surgery is contraindicated. Both splenectomised and non-splenectomised patient groups were considered in the analysis. Two economic models were presented, one for a watch-and-rescue treatment scenario and the second for the long-term treatment of patients with more severe ITP. The submissions evidence was sourced from the relatively high-quality RAISE [RAndomized placebo-controlled Idiopathic thrombocytopenic purpura (ITP) Study with Eltrombopag] randomised controlled trial. The study indicated a statistically significant difference in favour of eltrombopag compared with placebo in the odds of achieving the primary outcome of a platelet count of between 50 and 400 × 109/l during the 6-month treatment period (odds ratio 8.2, 99% confidence interval 3.6 to 18.7). In the eltrombopag group, 50/83 (60%) non-splenectomised patients and 18/49 (37%) splenectomised patients achieved this outcome. Median duration of response for all patients was 10.9 weeks (splenectomised patients 6 weeks and non-splenectomised patients 13.4 weeks). Patients treated with eltrombopag required less rescue medication and had lower odds of bleeding events than placebo-treated subjects in both patient groups. In the watch-and-rescue economic model, the ERG found that substantial reductions in the cost of eltrombopag are needed for the incremental cost-effectiveness ratio (ICER) to fall below £ 30,000. Further analyses found that the ICER varied from £33,561 to £ 103,500 per quality-adjusted life-year (QALY) (splenectomised) and from £ 39,657 to £ 150,245 per QALY (non-splenectomised). Other than bleeding, no adverse events were modelled. In relation to the long-term treatment model, the ERG found that using non-randomised non-comparative data may result in biased estimates of unknown magnitude and direction. None of the treatment sequences resulted in an ICER approaching the recommended threshold of £ 30,000. The base-case results, using a 2-year time horizon and prescribing eltrombopag as second-line treatment post rituximab, were found to be favourable towards eltrombopag. In conclusion, based on the MS and additional ERG work, eltrombopag appears to be a safe treatment for ITP (although long-term follow-up studies are awaited) and has short-term efficacy. However, there is no robust evidence on long-term efficacy or cost-effectiveness of eltrombopag, and there is a lack of robust direct evidence on the effectiveness and cost-effectiveness of eltrombopag compared with other relevant comparators. NICE did not recommend eltrombopag for the treatment of chronic ITP within its marketing authorisation for splenectomised or non-splenectomised patients.

Should weight loss and maintenance programmes be designed differently for men? A systematic review of long-term randomised controlled trials presenting data for men and women: The ROMEO Project

We systematically reviewed the randomised controlled trial (RCT) evidence for long-term (≥12 months) weight management interventions for obese men in contrast to women to help understand whether programmes should be designed differently for men. We searched 11 databases up to October 2014. Twenty-two RCTs reported data separately for men and women in weight loss or weight maintenance interventions. We found men were under-represented in RCTs of weight loss interventions open to both sexes. Men comprised 36% of participants (4771 from 13,305 participants). Despite this, men were 11% (95% CI 8-14%, p<0.001) more likely to be trial completers compared to women. The trials did not report service user consultation and none were designed to investigate whether men and women responded differently to given interventions. Our meta-analysis of 13 trials showed no significant difference in weight loss between men and women, either for weight loss in kg (p=0.90) or percentage weight loss (p=0.78), although men tended to lose more weight with intensive low fat reducing diets, with or without meal replacements, and structured physical activity/exercise programmes than women. Orlistat was less beneficial for men for weight maintenance. Individual support and tailoring appeared more helpful for men than women. We found evidence that men and women respond differently to, and have different preferences for, varying types of weight management programme. We suggest that it is important to understand mens views on weight loss, as this is likely to also improve the uptake and effectiveness of programmes for men.

Elucigene FH20 and LIPOchip for the diagnosis of familial hypercholesterolaemia: a systematic review and economic evaluation

BACKGROUND Familial hypercholesterolemia (FH) is an autosomal dominant genetic condition causing a high risk of coronary heart disease. The prevalence of this disease is about 1 in 500 in the UK, affecting about 120,000 people across the whole of the UK. Current guidelines recommend DNA testing, however, these guidelines are poorly implemented, therefore 102,000 or 85% of this group remain undiagnosed. OBJECTIVES To assess the diagnostic accuracy, effect on patient outcomes and cost-effectiveness of Elucigene FH20 and LIPOchip for the diagnosis of FH. DATA SOURCES Electronic databases including MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, BIOSIS, Science Citation Index, Conference Proceedings Citation Index - Science and Cochrane Controlled Trials Register were searched until January 2011. REVIEW METHODS A systematic review of the literature on diagnostic accuracy was carried out according to standard methods. An economic model was constructed to assess the cost-effectiveness of alternative diagnostic strategies for the confirmation of clinically diagnosed FH in index cases and for the identification and subsequent testing of first-, second- and possibly third-degree biological relatives of the index case. Twelve strategies were evaluated linking diagnostic accuracy to treatment outcomes and hence quality-adjusted life-years (QALYs). Deterministic and probabilistic sensitivity analyses were undertaken to investigate model and parameter uncertainty. RESULTS Fifteen studies were included for diagnostic accuracy; three reported Elucigene FH20, five reported LIPOchip, four reported low-density lipoprotein cholesterol (LDL-C) tests and three reported an age- and gender-specific LDL-C test against a reference standard of comprehensive genetic analysis (CGA). Sensitivity ranged from 44% to 52% for Elucigene FH20 and from 33.3% to 94.5% for various versions of LIPOchip in detecting FH-causing mutations in patients with a clinical diagnosis of FH. For LIPOchip version 10 (designed to detect 189 UK specific mutations), sensitivity would be 78.5% (based on single-centre data - Progenika, personal communication). For all other Elucigene FH20 or LIPOchip studies (apart from one LIPOchip study), specificity could not be calculated as no false-positive results could be derived from the given data. The LDL-C test was generally reported to be highly sensitive but with low specificity. For age- and gender-specific LDL-C cut-offs for cascade testing, sensitivity ranged from 68% to 96%. One UK-based study reported sensitivity of 91% and specificity of 93%. For the cost-effectiveness review, only one study reporting cost-effectiveness of any one of the comparators for this assessment was identified. Pre-screen strategies such as Elucigene FH20 followed by CGA were not cost-effective and were dominated by the single more comprehensive tests (e.g. CGA). Of the non-dominated strategies, Elucigene FH20, LIPOchip platform (Spain) and CGA were all cost-effective with associated incremental cost-effectiveness ratios (ICERs) relative to LDL-C of dominance (test is less costly and more effective), £871 and £1030 per QALY gained respectively. CGA generates the greatest QALY gain and, although other tests have lower ICERs relative to LDL-C, this is at the expense of QALY loss compared with the CGA test. Probabilistic sensitivity analysis shows that CGA is associated with an almost 100% probability of cost-effectiveness at the conventional value of willingness to pay of £20,000 per QALY gain. LIMITATIONS There was much uncertainty regarding the diagnostic accuracy of the included tests, with wide variation in sensitivity across reported studies. A lack of published information for the most recent version of LIPOchip created additional uncertainty, especially in relation to the chips ability to detect copy number changes. For the economic modelling, we aimed to choose the best studies for the base-case sensitivity of the tests; however, a number of informed choices based on clinical expert opinion had to be made in the absence of published studies for a number of other parameters in the modelling. This adds some uncertainty to our results, although it is unlikely that these would be sufficient in magnitude to alter our main results and conclusions. CONCLUSIONS As targeted tests designed to detect a limited number of genetic mutations, Elucigene FH20 and LIPOchip cannot detect all cases of FH, in contrast with CGA. CGA is therefore the most effective test in terms of sensitivity and QALY gain, and is also highly cost-effective with an associated ICER of £1030 per QALY gain relative to current practice (LDL-C). Other tests such as Elucigene FH20 and LIPOchip are also cost-effective; however, because of inferior sensitivity compared with CGA, these tests offer cost savings but at the expense of large QALY losses compared with CGA. Further prospective multicentred studies are required to evaluate the diagnostic accuracy of new and emerging tests for FH with the LDL-C test in patients with a clinical diagnosis based on the Simon Broome criteria. Such studies should verify both test-positive and -negative results against a reference standard of CGA and should include a full economic evaluation. FUNDING The National Institute for Health Research Health Technology Assessment programme.

Efficacy and Cost of an Exercise Program for Functionally Impaired Older Patients With Heart FailureClinical Perspective

Background—Little is known about the optimum way to deliver exercise to older, functionally impaired patients with heart failure. We tested whether an exercise program tailored to the needs of these patients could improve exercise capacity and quality of life or reduce costs to the National Health Service. Methods and Results—The study design was a parallel-group, single-blind, randomized controlled trial. Patients aged ≥70 years with symptomatic heart failure and left ventricular systolic dysfunction were randomized to either 24 weeks of exercise training or usual care. Six-minute walk distance was the primary outcome; markers of physical function, quality of life, health status, and daily activity were measured at baseline and 8 and 24 weeks. Carer strain and healthcare costs were also recorded. A total of 107 participants were randomized (mean age, 80 years; men, 72 [67%]). Six-minute walk distance did not improve compared to that of the control group at 8 weeks (−16.9 m; 95% CI, −41.8 to 7.9 m; P=0.18) or at 24 weeks (−5.3 m; 95% CI, −32.6 to 22.0 m; P=0.70). For secondary outcomes, only the sit-to-stand test improved significantly at 24 weeks (−6.4 s; 95% CI, −12.2 to 0.6 s; P=0.03); there was no difference in change for the Minnesota Living With Heart Failure score (0.1 points; 95% CI, −0.9 to 1.1 points; P=0.83) at 24 weeks. Carer strain did not decrease at 24 weeks (difference, −0.5 points; 95% CI, −8.3 to 7.3 points; P=0.80), and there was no difference in overall healthcare costs. Conclusions—This exercise intervention did not improve exercise capacity or quality of life in older patients with heart failure and was not cost saving to the National Health Service. Clinical Trial Registration—URL: http://www.controlled-trials.com. Unique identifier: ISRCTN51615566.