Cost-effectiveness of a national exercise referral programme for primary care patients in Wales: results of a randomised controlled trial.

BACKGROUND: A recent HTA review concluded that there was a need for RCTs of exercise referral schemes (ERS) for people with a medical diagnosis who might benefit from exercise. Overall, there is still uncertainty as to the cost-effectiveness of ERS. Evaluation of public health interventions places challenges on conventional health economics approaches. This economic evaluation of a national public health intervention addresses this issue of where ERS may be most cost effective through subgroup analysis, particularly important at a time of financial constraint. METHOD: This economic analysis included 798 individuals aged 16 and over (55% of the randomised controlled trial (RCT) sample) with coronary heart disease risk factors and/or mild to moderate anxiety, depression or stress. Individuals were referred by health professionals in a primary care setting to a 16 week national exercise referral scheme (NERS) delivered by qualified exercise professionals in local leisure centres in Wales, UK. Health-related quality of life, health care services use, costs per participant in NERS, and willingness to pay for NERS were measured at 6 and 12 months. RESULTS: The base case analysis assumed a participation cost of £385 per person per year, with a mean difference in QALYs between the two groups of 0.027. The incremental cost-effectiveness ratio was £12,111 per QALY gained. Probabilistic sensitivity analysis demonstrated an 89% probability of NERS being cost-effective at a payer threshold of £30,000 per QALY. When participant payments of £1 and £2 per session were considered, the cost per QALY fell from £12,111 (base case) to £10,926 and £9,741, respectively. Participants with a mental health risk factor alone or in combination with a risk of chronic heart disease generated a lower ICER (£10,276) compared to participants at risk of chronic heart disease only (£13,060). CONCLUSIONS: Results of cost-effectiveness analyses suggest that NERS is cost saving in fully adherent participants. Though full adherence to NERS (62%) was higher for the economics sample than the main sample (44%), results still suggest that NERS can be cost-effective in Wales with respect to existing payer thresholds particularly for participants with mental health and CHD risk factors. TRIAL REGISTRATION: Current Controlled Trials ISRCTN47680448.

An evaluation of the effectiveness and cost effectiveness of the National Exercise Referral Scheme in Wales, UK: a randomised controlled trial of a public health policy initiative.

BACKGROUND: The Wales National Exercise Referral Scheme (NERS) is a 16-week programme including motivational interviewing, goal setting and relapse prevention. METHOD: A pragmatic randomised controlled trial with nested economic evaluation of 2160 inactive participants with coronary heart disease risk (CHD, 1559, 72%), mild to moderate depression, anxiety or stress (79, 4%) or both (522, 24%) randomised to receive (1) NERS or (2) normal care and brief written information. Outcome measures at 12 months included the 7-day physical activity recall, the hospital anxiety and depression scale. RESULTS: Ordinal regression identified increased physical activity among those randomised to NERS compared with those receiving normal care in all participants (OR 1.19, 95% CI 0.99 to 1.43), and among those referred for CHD only (OR 1.29, 95% CI 1.04 to 1.60). For those referred for mental health reason alone, or in combination with CHD, there were significantly lower levels of anxiety (-1.56, [corrected] 95% CI -2.75 to -0.38) and depression (-1.39, [corrected] 95% CI -2.60 to -0.18), but no effect on physical activity. The base-case incremental cost-effectiveness ratio was £12,111 per quality adjusted life year, falling to £9741 if participants were to contribute £2 per session. CONCLUSIONS: NERS was effective in increasing physical activity among those referred for CHD risk only. Among mental health referrals, NERS did not influence physical activity but was associated with reduced anxiety and depression. Effects were dependent on adherence. NERS is likely to be cost effective with respect to prevailing payer thresholds. Trial registration Current Controlled Trials ISRCTN47680448.

FIRE (Facilitating Implementation of Research Evidence): a study protocol.

BACKGROUND: Research evidence underpins best practice, but is not always used in healthcare. The Promoting Action on Research Implementation in Health Services (PARIHS) framework suggests that the nature of evidence, the context in which it is used, and whether those trying to use evidence are helped (or facilitated) affect the use of evidence. Urinary incontinence has a major effect on quality of life of older people, has a high prevalence, and is a key priority within European health and social care policy. Improving continence care has the potential to improve the quality of life for older people and reduce the costs associated with providing incontinence aids. OBJECTIVES: This study aims to advance understanding about the contribution facilitation can make to implementing research findings into practice via: extending current knowledge of facilitation as a process for translating research evidence into practice; evaluating the feasibility, effectiveness, and cost-effectiveness of two different models of facilitation in promoting the uptake of research evidence on continence management; assessing the impact of contextual factors on the processes and outcomes of implementation; and implementing a pro-active knowledge transfer and dissemination strategy to diffuse study findings to a wide policy and practice community. SETTING AND SAMPLE: Four European countries, each with six long-term nursing care sites (total 24 sites) for people aged 60 years and over with documented urinary incontinence METHODS AND DESIGN: Pragmatic randomised controlled trial with three arms (standard dissemination and two different programmes of facilitation), with embedded process and economic evaluation. The primary outcome is compliance with the continence recommendations. Secondary outcomes include proportion of residents with incontinence, incidence of incontinence-related dermatitis, urinary tract infections, and quality of life. Outcomes are assessed at baseline, then at 6, 12, 18, and 24 months after the start of the facilitation interventions. Detailed contextual and process data are collected throughout, using interviews with staff, residents and next of kin, observations, assessment of context using the Alberta Context Tool, and documentary evidence. A realistic evaluation framework is used to develop explanatory theory about what works for whom in what circumstances. TRIAL REGISTRATION: Current Controlled Trials ISRCTN11598502.

How effective is low vision service provision? A systematic review.

Visual impairment is a large and growing socioeconomic problem. Good evidence on rehabilitation outcomes is required to guide service development and improve the lives of people with sight loss. Of the 478 potentially relevant articles identified, only 58 studies met our liberal inclusion criteria, and of these only 7 were randomized controlled trials. Although the literature is sufficient to confirm that rehabilitation services result in improved clinical and functional ability outcomes, the effects on mood, vision-related quality of life (QoL) and health-related QoL are less clear. There are some good data on the performance of particular types of intervention, but almost no useful data about outcomes in children, those of working age, and other groups. There were no reports on cost effectiveness. Overall, the number of well-designed and adequately reported studies is pitifully small; visual rehabilitation research needs higher quality research. We highlight study design and reporting considerations and suggest a future research agenda.

Enhancing ventilation in homes of children with asthma: pragmatic randomised controlled trial.

BACKGROUND: Few robust studies have tested whether enhancing housing also improves health. AIM: To evaluate the effectiveness of installing ventilation systems, and central heating where necessary, in the homes of children with moderate or severe asthma. DESIGN AND SETTING: Pragmatic randomised controlled trial (RCT) in homes within Wrexham County Borough, Wales, UK. METHOD: A pragmatic RCT was carried out, of a tailored package of housing improvements providing adequate ventilation and temperature, following inspection by a housing officer. One hundred and ninety-two children with asthma aged 5 to 14 years, identified from general practice registers, were randomised to receive this package, either immediately or a year after recruitment. At baseline, and after 4 and 12 months, parents reported their child's asthma-specific and generic quality of life, and days off school. RESULTS: The package improved parent-reported asthma-specific quality of life significantly at both 4 and 12 months. At 12 months, this showed an adjusted mean difference between groups of 7.1 points (95% confidence interval [CI] = 2.8 to 11.4, P= 0.001): a moderate standardised effect size of 0.42. The generic quality-of-life scale showed reported physical problems were significantly reduced at 4 months, but not quite at 12 months, when the mean difference was 4.5 (95% CI = -0.2 to 9.1, P= 0.061). The improvement in psychosocial quality of life at 12 months was not significant, with a mean difference of 2.2 (95% CI = -1.9 to 6.4, P= 0.292). Parent-reported school attendance improved, but not significantly. CONCLUSION: This novel and pragmatic trial, with integrated economic evaluation, found that tailored improvement of the housing of children with moderate to severe asthma significantly increases parent-reported asthma-related quality of life and reduces physical problems. Collaborative housing initiatives have potential to improve health.

Enhancing ventilation in homes of children with asthma: cost-effectiveness study alongside randomised controlled trial.

BACKGROUND: There has been little rigorous economic analysis of the relationship between asthma and improved housing. AIM: To evaluate the cost-effectiveness of installing ventilation systems, and central heating if necessary, in homes of children with 'moderate' or 'severe' asthma. DESIGN AND SETTING: An incremental cost-effectiveness analysis alongside a pragmatic randomised controlled trial of a tailored package of housing modifications designed to improve ventilation and household heating in homes within Wrexham County Borough, Wales, UK. METHOD: A total of 177 children aged between 5 and 14 years, identified from general practice registers, were studied. Parents reported on the quality of life of their children over a 12-month period. General practices reported on health-service resources used by those children, and their asthma-related prescriptions, over the same period. RESULTS: The tailored package shifted 17% of children in the intervention group from 'severe' to 'moderate' asthma, compared with a 3% shift in the control group. The mean cost of these modifications was £1718 per child treated or £12300 per child shifted from 'severe' to 'moderate'. Healthcare costs over 12 months following randomisation did not differ significantly between intervention and control groups. Bootstrapping gave an incremental cost-effectiveness ratio (ICER) of £234 per point improvement on the 100-point PedsQL™ asthma-specific scale, with 95% confidence interval (CI) = £140 to £590. The ICER fell to £165 (95% CI = £84 to £424) for children with 'severe' asthma. CONCLUSION: This novel and pragmatic trial, with integrated economic evaluation, reported that tailored improvement of the housing of children with moderate to severe asthma is likely to be a cost-effective use of public resources. This is a rare example of evidence for collaboration between local government and the NHS.

Activity Increase Despite Arthritis (AÏDA): phase II randomised controlled trial of an active management booklet for hip and knee osteoarthritis in primary care.

BACKGROUND: The Hip & Knee Book: Helping you cope with osteoarthritis was developed to change disadvantageous beliefs and encourage physical activity in people with hip or knee osteoarthritis. AIM: To assess the feasibility of conducting a definitive randomised controlled trial (RCT) of this evidence-based booklet in people with hip or knee osteoarthritis. DESIGN: Phase II feasibility randomised controlled trial (RCT). METHOD: Computerised searches of patients' record databases identified people with osteoarthritis of the hip or knee, who were invited to participate in the RCT comparing the new booklet with a control booklet. Outcomes were measured at baseline, 1 month, and 3 months, and included: beliefs about hip and knee pain, exercise, and fear avoidance; level of physical activity; and health service use. RESULTS: The trial methods were feasible in terms of recruitment, randomisation, and follow-up, but most participants recruited had longstanding established symptoms. After one and 3 months, there was a small relative improvement in illness, exercise, and fear-avoidance beliefs and physical activity level in The Hip & Knee Book group (n = 59) compared with the control group (n = 60), which provides some proof of principle for using these outcomes in future trials. CONCLUSION: This feasibility study provided proof of principle for testing The Hip & Knee Book in a larger definitive RCT.

Is exercise effective in promoting mental well-being in older age? A systematic review.

BACKGROUND: Promoting the mental well-being of older people has been neglected. AIM: To examine the clinical and cost-effectiveness of exercise and physical activity interventions on mental well-being in people aged 65+. DESIGN: Systematic review, meta-analysis, economic model. METHODS: Reports published in English, identified by searching 25 databases, 11 websites and references lists of systematic reviews. Eligible studies were those with a comparison or control group or offering qualitative evidence; exercise and physical activity interventions for people aged 65 and above living at home, in the community, in supported housing or in residential care homes; including outcome measures of mental well-being, not simply measures of depression or anxiety. Low-quality studies were excluded from the data synthesis. RESULTS: An overall effect of exercise on mental well-being was found (standardised effect size = 0.27; CI = 0.14-0.40). The included interventions were designed for older people, targeted those who are sedentary and delivered in a community setting, primarily through a group-based approach led by trained leaders. As a minimum, the evidence would suggest two exercise sessions per week, each of 45 min duration. There is some indication that exercise can also improve the mental well-being of frail elders. Economic evidence indicated incremental cost-effectiveness ratios (compared with minimal intervention) of pound 7300 and pound 12,100 per quality adjusted life year gained for community-based walking and exercise programmes, respectively. CONCLUSIONS: Mental well-being in later life is modifiable through exercise and physical activity. To generalise the findings, there is a need for more evidence of effectiveness from older people in the UK.

A pragmatic randomised controlled trial of the Welsh National Exercise Referral Scheme: protocol for trial and integrated economic and process evaluation.

BACKGROUND: The benefits to health of a physically active lifestyle are well established and there is evidence that a sedentary lifestyle plays a significant role in the onset and progression of chronic disease. Despite a recognised need for effective public health interventions encouraging sedentary people with a medical condition to become more active, there are few rigorous evaluations of their effectiveness. Following NICE guidance, the Welsh national exercise referral scheme was implemented within the context of a pragmatic randomised controlled trial. METHODS/DESIGN: The randomised controlled trial, with nested economic and process evaluations, recruited 2,104 inactive men and women aged 16+ with coronary heart disease (CHD) risk factors and/or mild to moderate depression, anxiety or stress. Participants were recruited from 12 local health boards in Wales and referred directly by health professionals working in a range of health care settings. Consenting participants were randomised to either a 16 week tailored exercise programme run by qualified exercise professionals at community sports centres (intervention), or received an information booklet on physical activity (control). A range of validated measures assessing physical activity, mental health, psycho-social processes and health economics were administered at 6 and 12 months, with the primary 12 month outcome measure being 7 day Physical Activity Recall. The process evaluation explored factors determining the effectiveness or otherwise of the scheme, whilst the economic evaluation determined the relative cost-effectiveness of the scheme in terms of public spending. DISCUSSION: Evaluation of such a large scale national public health intervention presents methodological challenges in terms of trial design and implementation. This study was facilitated by early collaboration with social research and policy colleagues to develop a rigorous design which included an innovative approach to patient referral and trial recruitment, a comprehensive process evaluation examining intervention delivery and an integrated economic evaluation. This will allow a unique insight into the feasibility, effectiveness and cost effectiveness of a national exercise referral scheme for participants with CHD risk factors or mild to moderate anxiety, depression, or stress and provides a potential model for future policy evaluations. TRIAL REGISTRATION: Current Controlled Trials ISRCTN47680448.

Economic evaluation alongside pragmatic randomised trials: developing a standard operating procedure for clinical trials units.

BACKGROUND: There is wide recognition that pragmatic randomised trials are the best vehicle for economic evaluation. This is because trials provide the best chance of ensuring internal validity, not least through the rigorous prospective collection of patient-specific data. Furthermore the marginal cost of collecting economic data alongside clinical data is typically modest. UK Clinical Research Collaboration (UKCRC) does not require a standard operating procedure (SOP) for economic evaluation as a prerequisite for trial unit registration. We judge that such a SOP facilitates the integration of health economics into trials. METHODS: A collaboration between health economists and trialists at Bangor University led to the development of a SOP for economic evaluation alongside pragmatic trials, in addition to the twenty SOPs required by UKCRC for registration, which include randomisation, data management and statistical analysis. RESULTS: Our recent telephone survey suggests that no other UKCRC-registered trials unit currently has an economic SOP. CONCLUSION: We argue that UKCRC should require, from all Trials Units undertaking economic evaluation and seeking registration or re-registration, a SOP for economic evaluation as one of their portfolio of supporting SOPs.

NHS and charitable funding for children and young people with cancer in England and Wales.

In 2005 the National Institute for Health and Clinical Excellence Guidance on Cancer Services: Improving Outcomes in Children and Young People with Cancer, identified the need to quantify the substantial contribution made by charities to NHS provision to this group of patients. This article quantifies the contribution in England and Wales. It identifies 51 charities established specifically to assist this patient group, estimates that 340 charities made some financial contribution and 28 organizations administered charitable funds for hospices. The financial contribution to services by charities was estimated to be between pound25 million and pound38 million in 2003, representing between one-third and a half of the total resources directed to the treatment and support of children and young people with cancer in specialist centres across England and Wales. Reliance on the substantial charitable funding of health care in England and Wales raises concerns over government responsibility, and the potential misalignment between NHS priorities and those of the charities.

Cost-utility analysis of osteopathy in primary care: results from a pragmatic randomized controlled trial.

BACKGROUND: Spinal pain is common and costly to health services and society. Management guidelines have encouraged primary care referral for spinal manipulation, but the evidence base is weak. More economic evaluations alongside pragmatic trials have been recommended. OBJECTIVE: Our aim was to assess the cost-utility of a practice-based osteopathy clinic for subacute spinal pain. METHODS: A cost-utility analysis was performed alongside a pragmatic single-centre randomized controlled trial in a primary care osteopathy clinic accepting referrals from 14 neighbouring practices in North West Wales. Patients with back pain of 2-12 weeks duration were randomly allocated to treatment with osteopathy plus usual GP care or usual GP care alone. Costs were measured from a National Health Service (NHS) perspective. All primary and secondary health care interventions recorded in GP notes were collected for the study period. We calculated quality adjusted life year (QALY) gains based on EQ-5D responses from patients in the trial, and then cost per QALY ratios. Confidence intervals (CIs) were estimated using non-parametric bootstrapping. RESULTS: Osteopathy plus usual GP care was more effective but resulted in more health care costs than usual GP care alone. The point estimate of the incremental cost per QALY ratio was 3560 pounds (80% CI 542 pounds-77,100 pounds). Sensitivity analysis examining spine-related costs alone and total costs excluding outliers resulted in lower cost per QALY ratios. CONCLUSION: A primary care osteopathy clinic may be a cost-effective addition to usual GP care, but this conclusion was subject to considerable random error. Rigorous multi-centre studies are needed to assess the generalizability of this approach.

Randomized osteopathic manipulation study (ROMANS): pragmatic trial for spinal pain in primary care.

BACKGROUND: Spinal pain is common and frequently disabling. Management guidelines have encouraged referral from primary care for spinal manipulation. However, the evidence base for these recommendations is weak. More pragmatic trials and economic evaluations have been recommended. OBJECTIVES: Our aim was to assess the effectiveness and health care costs of a practice-based osteopathy clinic for subacute spinal pain. METHODS: A pragmatic randomized controlled trial was carried out in a primary care osteopathy clinic accepting referrals from 14 neighbouring practices in North West Wales. A total of 201 patients with neck or back pain of 2-12 weeks duration were allocated at random between usual GP care and an additional three sessions of osteopathic spinal manipulation. The primary outcome measure was the Extended Aberdeen Spine Pain Scale (EASPS). Secondary measures included SF-12, EuroQol and Short-form McGill Pain Questionnaire. Health care costs were estimated from the records of referring GPs. RESULTS: Outcomes improved more in the osteopathy group than the usual care group. At 2 months, this improvement was significantly greater in EASPS [95% confidence interval (CI) 0.7-9.8] and SF-12 mental score (95% CI 2.7-10.7). At 6 months, this difference was no longer significant for EASPS (95% CI -1.5 to 10.4), but remained significant for SF-12 mental score (95% CI 1.0-9.9). Mean health care costs attributed to spinal pain were significantly greater by 65 UK pounds in the osteopathy group (95% CI 32-155 UK pounds). Though osteopathy also cost 22 UK pounds more in mean total health care cost, this was not significant (95% CI - 159 to 142 UK pounds). CONCLUSION: A primary care osteopathy clinic improved short-term physical and longer term psychological outcomes, at little extra cost. Rigorous multicentre studies are now needed to assess the generalizability of this approach.