The cost-effectiveness of the SPHERE intervention for the secondary prevention of coronary heart disease

Objectives: The Secondary Prevention of Heart disEase in geneRal practicE (SPHERE) trial has recently reported. This study examines the cost-effectiveness of the SPHERE intervention in both healthcare systems on the island of Ireland. Methods: Incremental cost-effectiveness analysis. A probabilistic model was developed to combine within-trial and beyond-trial impacts of treatment to estimate the lifetime costs and benefits of two secondary prevention strategies: Intervention - tailored practice and patient care plans; and Control - standardized usual care. Results: The intervention strategy resulted in mean cost savings per patient of 512.77 (95 percent confidence interval [CI], 1086.46-91.98) and an increase in mean quality-adjusted life-years (QALYs) per patient of 0.0051 (95 percent CI, 0.0101-0.0200), when compared with the control strategy. The probability of the intervention being cost-effective was 94 percent if decision makers are willing to pay €45,000 per additional QALY. Conclusions: Decision makers in both settings must determine whether the level of evidence presented is sufficient to justify the adoption of the SPHERE intervention in clinical practice. Copyright © Cambridge University Press 2010.

Quality of life and healthcare utilisation in cystic fibrosis:A multicentre UK study

The aim of our study was to discover the health status and healthcare utilisation associated with pulmonary exacerbations in cystic fibrosis (CF) and chronic Pseudomonas aeruginosa infection.

Patients with CF from five UK CF centres attended two visits, 8–12 weeks apart. They were classified at visit 1 as being in one of the three health states: no current pulmonary exacerbation; “mild” (no hospitalisation) pulmonary exacerbation; and “severe” (hospitalisation) pulmonary exacerbation. All patients completed the Cystic Fibrosis Questionnaire-Revised (CFQ-R) and EuroQol (EQ-5D) and a clinical form, and forced expiratory volume in 1 s (FEV1) was measured at visits 1 and 2. Annual healthcare utilisation data were collected.

94 patients of mean±sd age 28.5±8.2 yrs and FEV1 58.7±26.8% were recruited. 60 patients had no pulmonary exacerbation, 15 had a mild and 19 had a severe pulmonary exacerbation at visit 1. EQ-5D and CFQ-R data showed that the worse the exacerbation, the poorer the health-related quality of life (HRQoL). There were strong relationships between the CFQ-R and EQ-5D domain scores. The mean rate of pulmonary exacerbations per patient per year was 3.6 (1.5 in hospital and 2.2 at home). The mean length of stay per hospital pulmonary exacerbation was 9 days.

As exacerbation status worsens, patients experience worse HRQoL. There is a significant healthcare burden associated with treatment of pulmonary exacerbation and long-term prophylaxis.

Quality of life in men receiving radiotherapy and neo-adjuvant androgen deprivation for prostate cancer:Results from a prospective longitudinal study

Aim. To report a study measuring the quality of life and side effects in men receiving radiotherapy and hormone ablation for prostate cancer up to 1year after treatment. Background. Prostate cancer incidence is increasing with the result that more men are living longer with the disease and the side effects of treatment. It is important to know the effects this has on their quality of life. Design. Survey. Method. Between September 2006-September 2007, all men who were about to undergo radical conformal radiotherapy ± neo-adjuvant androgen deprivation for localized prostate cancer were invited to participate in the study; 149 men were recruited. They completed the European Organization on Research and Treatment of Cancer quality of life questionnaire C-30 and Prostate Cancer module PR25 at four time-points. Results. At 4-6weeks after radiotherapy, participants experienced the biggest relative decline in global quality of life, social, physical, and role functioning and an increase in treatment side effects. At 6months postradiotherapy the majority of men experienced an improvement in their side effects. However, a minority of men were experiencing severe side effects of radiotherapy at 1year post-treatment. Single men and men who had a low quality of life prior to radiotherapy, reported a lower quality of life at 1year after treatment in comparison to married men. Conclusion. Men with prostate cancer suffer limitations due to the symptoms they experience and disruption to their quality of life. It is essential that nurses develop and deliver follow-up care which is flexible and appropriate to the individual needs of these men. © 2012 Blackwell Publishing Ltd.

Cost-effectiveness of internal limiting membrane peeling versus no peeling for patients with an idiopathic full-thickness macular hole:Results from a randomised controlled trial

Aim: To determine whether internal limiting membrane (ILM) peeling is cost-effective compared with no peeling for patients with an idiopathic stage 2 or 3 full-thickness macular hole. Methods: A cost-effectiveness analysis was performed alongside a randomised controlled trial. 141 participants were randomly allocated to receive macular-hole surgery, with either ILM peeling or no peeling. Health-service resource use, costs and quality of life were calculated for each participant. The incremental cost per quality-adjusted life year (QALY) gained was calculated at 6 months. Results: At 6 months, the total costs were on average higher (£424, 95% CI -182 to 1045) in the No Peel arm, primarily owing to the higher reoperation rate in the No Peel arm. The mean additional QALYs from ILM peel at 6 months were 0.002 (95% CI 0.01 to 0.013), adjusting for baseline EQ-5D and other minimisation factors. A mean incremental cost per QALY was not computed, as Peeling was on average less costly and slightly more effective. A stochastic analysis suggested that there was more than a 90% probability that Peeling would be cost-effective at a willingness-to-pay threshold of £20 000 per QALY. Conclusion: Although there is no evidence of a statistically significant difference in either costs or QALYs between macular hole surgery with or without ILM peeling, the balance of probabilities is that ILM Peeling is likely to be a cost-effective option for the treatment of macular holes. Further long-term follow-up data are needed to confirm these findings.

Late-stage, primary open-angle glaucoma in Europe:Social and health care maintenance costs and quality of life of patients from 4 countries

Objective: The purpose of this study was to estimate costs and quality of life (QoL) of late-stage glaucoma patients in 4 European countries. Methods: Retrospective review of medical charts of patients with POAG who were followed in a low-vision or vision rehabilitation center in one of 4 countries for at least 1 year was used to determine patient characteristics, health status, and health care resource use. Visual impairment was measured by best-corrected visual acuity (Snellen score). Patients were also interviewed over the telephone in order to assess their health-related QoL (using EuroQol EQ-5D) and use of resources including: the number of visits to rehabilitation centers, visits to hospital and non-hospital specialists, the use of low-vision devices, medication, tests, and the use of hired home help. The costs associated with resource use were calculated from the perspective of a third-party payer of health and social care based on resource usage and unit costs in each country. Results: Patients undergoing visual rehabilitation in France (n=21), Denmark (n=59), Germany (n=60), and the United Kingdom (n=22) were identified, interviewed and had their medical charts reviewed. Annual maintenance costs of late-stage glaucoma amounted to €830 (±445) on average. Average home help costs were more than 3 times higher. QoL, on average, was 0.65 (±0.28). QoL was positively correlated with the level of visual acuity in the patients' best eye. On the other hand, visual acuity was also positively correlated to health care costs, but negatively correlated to costs of home help. Conclusions: The study was limited by its observational, uncontrolled design. The finding that late-stage glaucoma is associated with higher home help costs than health care maintenance costs suggests that potential savings from a better preventive treatment are to be found for social care payers rather than health care payers. © 2008 Informa UK Ltd All rights reserved.

The clinical effectiveness and cost-effectiveness of screening for open angle glaucoma:A systematic review and economic evaluation

Objectives: To assess whether open angle glaucoma (OAG) screening meets the UK National Screening Committee criteria, to compare screening strategies with case finding, to estimate test parameters, to model estimates of cost and cost-effectiveness, and to identify areas for future research. Data sources: Major electronic databases were searched up to December 2005. Review methods: Screening strategies were developed by wide consultation. Markov submodels were developed to represent screening strategies. Parameter estimates were determined by systematic reviews of epidemiology, economic evaluations of screening, and effectiveness (test accuracy, screening and treatment). Tailored highly sensitive electronic searches were undertaken. Results: Most potential screening tests reviewed had an estimated specificity of 85% or higher. No test was clearly most accurate, with only a few, heterogeneous studies for each test. No randomised controlled trials (RCTs) of screening were identified. Based on two treatment RCTs, early treatment reduces the risk of progression. Extrapolating from this, and assuming accelerated progression with advancing disease severity, without treatment the mean time to blindness in at least one eye was approximately 23 years, compared to 35 years with treatment. Prevalence would have to be about 3-4% in 40 year olds with a screening interval of 10 years to approach cost-effectiveness. It is predicted that screening might be cost-effective in a 50-year-old cohort at a prevalence of 4% with a 10-year screening interval. General population screening at any age, thus, appears not to be cost-effective. Selective screening of groups with higher prevalence (family history, black ethnicity) might be worthwhile, although this would only cover 6% of the population. Extension to include other at-risk cohorts (e.g. myopia and diabetes) would include 37% of the general population, but the prevalence is then too low for screening to be considered cost-effective. Screening using a test with initial automated classification followed by assessment by a specialised optometrist, for test positives, was more cost-effective than initial specialised optometric assessment. The cost-effectiveness of the screening programme was highly sensitive to the perspective on costs (NHS or societal). In the base-case model, the NHS costs of visual impairment were estimated as £669. If annual societal costs were £8800, then screening might be considered cost-effective for a 40-year-old cohort with 1% OAG prevalence assuming a willingness to pay of £30,000 per quality-adjusted life-year. Of lesser importance were changes to estimates of attendance for sight tests, incidence of OAG, rate of progression and utility values for each stage of OAG severity. Cost-effectiveness was not particularly sensitive to the accuracy of screening tests within the ranges observed. However, a highly specific test is required to reduce large numbers of false-positive referrals. The findings that population screening is unlikely to be cost-effective are based on an economic model whose parameter estimates have considerable uncertainty, in particular, if rate of progression and/or costs of visual impairment are higher than estimated then screening could be cost-effective. Conclusions: While population screening is not cost-effective, the targeted screening of high-risk groups may be. Procedures for identifying those at risk, for quality assuring the programme, as well as adequate service provision for those screened positive would all be needed. Glaucoma detection can be improved by increasing attendance for eye examination, and improving the performance of current testing by either refining practice or adding in a technology-based first assessment, the latter being the more cost-effective option. This has implications for any future organisational changes in community eye-care services. Further research should aim to develop and provide quality data to populate the economic model, by conducting a feasibility study of interventions to improve detection, by obtaining further data on costs of blindness, risk of progression and health outcomes, and by conducting an RCT of interventions to improve the uptake of glaucoma testing. © Queen's Printer and Controller of HMSO 2007. All rights reserved.

Lung stereotactic body radiation therapy (SBRT) delivered over 4 or 11days: A comparison of acute toxicity and quality of life.

Abstract
PURPOSE:
The optimal duration over which lung SBRT should be delivered is unknown. We conducted a randomized pilot study in patients treated with four fractions of lung SBRT delivered over 4 or over 11days.
METHODS:
Patients with a peripheral solitary lung tumor (NSCLC or pulmonary metastasis) ?5cm were eligible. For NSCLC lung tumors ?3cm, a dose of 48Gy in 4 fractions was used, otherwise 52Gy in 4 fractions was delivered. Patients were randomized to receive treatment over 4 consecutive days or over 11days. The primary end-point was acute grade ?2 toxicity. Secondary end-points included quality of life (QOL) assessed using the EORTC QLQ-C30 and QLQ-LC13 questionnaires.
RESULTS:
Fifty four patients were enrolled. More patients in the 11day group had respiratory symptoms at baseline. 55.6% patients treated over 4days and 33.3% of patients treated over 11days experienced acute grade ?2 toxicity (p=0.085). Dyspnea, fatigue and coughing domains were worse in the 11day group at baseline. At 1 and 4months, more patients in the 4day group experienced a clinically meaningful worsening in the dyspnea QOL domain compared to the 11day group (44.5% vs 15.4%, p=0.02; 38.5% vs 12.0%, p=0.03, respectively). However, raw QOL scores were not different at these time-points between treatment groups.
CONCLUSIONS:
Grade 2 or higher acute toxicity was more common in the 4day group, approaching statistical significance. More patients treated on 4 consecutive days reported a clinically meaningful increase in dyspnea, although interpretation of these results is challenging due to baseline imbalance between treatment groups. Larger studies are required to validate these results.

Cost-effectiveness of tooth replacement strategies for partially dentate elderly: a randomized controlled clinical trial

OBJECTIVE: To conduct a cost-effectiveness analysis comparing two different tooth replacement strategies for partially dentate older patients, namely partial removable dental prostheses (RDP) and functionally orientated treatment based on the shortened dental arch concept (SDA).

METHODS: Ninety-two partially dentate older patients completed a randomized controlled clinical trial. Patients were randomly allocated to two treatment groups: the RDP group and the SDA group. Treatment effect was measured using impact on oral health-related quality of life (OHrQOL), and the costs involved in providing and maintaining care were recorded for all patients. Patients were followed for 12 months after treatment intervention. All treatment was provided by a single operator.

RESULTS: The total cost of achieving the minimally important clinical difference (MID) in OHrQOL for an average patient in the RDP group was €464.64. For the SDA group, the cost of achieving the MID for an average patient was €252.00. The cost-effectiveness ratio was therefore 1:1.84 in favour of SDA treatment.

CONCLUSION: With an increasingly ageing population, many patients will continue to benefit from removable prostheses to replace their missing natural teeth. From a purely economic standpoint, the results from this analysis suggest that the treatment of partially dentate older adults should be focused on functionally orientated treatment because it is simply more cost-effective.

A preliminary report of the cost-effectiveness of tooth replacement strategies for partially dentate elders

OBJECTIVE: To compare the cost-effectiveness of conventional treatment using partial dentures with functionally orientated treatment to replace missing teeth for partially dentate elders using a randomised controlled clinical trial.

BACKGROUND: In many countries, including the Republic of Ireland, the only publically funded treatment option offered to partially dentate older patients is a removable partial denture. However, evidence suggests that these removable prostheses are unpopular with patients and can potentially increase the risk of further dental disease and subsequent tooth loss.

MATERIALS AND METHODS: Fourty-four partially dentate patients aged 65 years and older were recruited. Patients were randomly assigned to the two treatment arms of the study. The conventional treatment group received removable partial dentures to replace all missing natural teeth. The functionally orientated group was restored to a Shortened Dental Arch (SDA) of 10 occluding contacts using resin-bonded bridgework (RBB). The costs associated with each treatment were recorded. Effectiveness was measured in terms of the impact on oral health-related quality of life (OHRQoL) using OHIP-14.

RESULTS: Both groups reported improvements in OHRQoL 1 month after completion of treatment. The conventional treatment group required 8.3 clinic visits as compared to 4.4 visits for the functionally orientated group. The mean total treatment time was 183 min 19 s for the conventional group vs. 124 min 8 s for the functionally orientated group. The average cost of treatment for the conventional group was 487.74 Euros compared to 356.20 Euros for the functional group.

CONCLUSIONS: Functionally orientated treatment was more cost-effective than conventional treatment in terms of treatment effect and opportunity costs to the patients' time.

Metastatic non-small cell lung cancer: a benchmark for quality end-of-life cancer care?

Objectives: To investigate the quality of end-of-life care for patients with metastatic non-small cell lung cancer (NSCLC). Design and participants: Retrospective cohort study of patients from first hospitalisation for metastatic disease until death, using hospital, emergency department and death registration data from Victoria, Australia, between 1 July 2003 and 30 June 2010. Main outcome measures: Emergency department and hospital use; aggressiveness of care including intensive care and chemotherapy in last 30 days; palliative and supportive care provision; and place of death. Results: Metastatic NSCLC patients underwent limited aggressive treatment such as intensive care (5%) and chemotherapy (< 1%) at the end of life; however, high numbers died in acute hospitals (42%) and 61% had a length of stay of greater than 14 days in the last month of life. Although 62% were referred to palliative care services, this occurred late in the illness. In a logistic regression model adjusted for year of metastasis, age, sex, metastatic site and survival, the odds ratio (OR) of dying in an acute hospital bed compared with death at home or in a hospice unit decreased with receipt of palliative care (OR, 0.25; 95% CI, 0.21–0.30) and multimodality supportive care (OR, 0.65; 95% CI, 0.56–0.75). Conclusion: Because early palliative care for patients with metastatic NSCLC is recommended, we propose that this group be considered a benchmark of quality end-of-life care. Future work is required to determine appropriate quality-of-care targets in this and other cancer patient cohorts, with particular focus on the timeliness of palliative care engagement.

Cost Effectiveness of Tooth Replacement Strategies for Partially Dentate Elders

Objectives: This study aimed to compare the cost effectiveness of conventional treatment using partial dentures with functionally-orientated treatment based on the shortened dental arch concept to replace missing teeth for partially dentate elders.
Methods: 44 partially dentate patients aged 65 years and older were recruited following routine dental assessment at a university dental hospital. Patients consented to and were randomly assigned to the two treatment arms. The conventional treatment group received a removable partial denture to replace all missing natural teeth. The functionally-orientated group were restored to a shortened dental arch of 10 occluding contacts using resin bonded bridgework. The costs associated with each treatment were recorded including laboratory charges, treatment time and opportunity costs. The impact on quality of life (OHRQoL) was measured using the 14-item Oral Health Impact Profile.
Results: Both groups reported improvements in OHRQoL after completion of treatment. For the conventional group, the mean OHIP-14 score decreased from 12.4 pre-operatively to 3.3 post-operatively (p<0.001). In the functionally-orientated group the OHIP-14 score decreased from 11.4 to 1.8 following treatment (p<0.001). On average the conventional treatment group required 8.3 clinic visits as compared to 4.4 visits for the functionally-orientated group. The mean total treatment time was 183 minutes 19 seconds for the conventional group versus 124 minutes 8 seconds for the functionally-orientated group. The conventional treatment group had an average of 6.33 teeth replaced at a laboratory cost of 337.31 Euros. The functionally-orientated group had an average of 2.64 teeth replaced at a laboratory cost of 244.05 Euros.
Conclusions: Restoration to a shortened dental arch using functionally-orientated treatment resulted in a similar improvement in OHRQoL with fewer clinic visits, less operative time and at a lower laboratory cost compared with conventional treatment.

Myeloproliferative neoplasm patient symptom burden and quality of life: evidence of significant impairment compared to controls

The myeloproliferative neoplasms (MPN) including polycythaemia vera (PV), essential thrombocythaemia and primary myelofibrosis (PMF) are rare diseases contributing to significant morbidity. Symptom management is a prime treatment objective but current symptom assessment tools have not been validated compared to the general population. The MPN-symptom assessment form (MPN-SAF), a reliable and validated clinical tool to assess MPN symptom burden, was administered to MPN patients (n = 106) and, for the first time, population controls (n = 124) as part of a UK case–control study. Mean symptom scores were compared between patients and controls adjusting for potential confounders. Mean patient scores were compared to data collected by the Mayo Clinic, USA on 1,446 international MPN patients to determine patient group representativeness. MPN patients had significantly higher mean scores than controls for 25 of the 26 symptoms measured (P < 0.05); fatigue was the most common symptom (92.4% and 78.1%, respectively). Female MPN patients suffered worse symptom burden than male patients (P < 0.001) and substantially worse burden than female controls (P < 0.001). Compared to the Mayo clinic patients, MPN-UK patients reported similar symptom burden but lower satiety (P = 0.046). Patients with PMF reported the worst symptom burden (88.3%); significantly higher than PV patients (P < 0.001). For the first time we report quality of life was worse in MPN-UK patients compared with controls (P < 0.001).

PAlliative Care in chronic Kidney diSease: the PACKS study—quality of life, decision making, costs and impact on carers in people managed without dialysis

BACKGROUND: The number of patients with advanced chronic kidney disease opting for conservative management rather than dialysis is unknown but likely to be growing as increasingly frail patients with advanced renal disease present to renal services. Conservative kidney management includes ongoing medical input and support from a multidisciplinary team. There is limited evidence concerning patient and carer experience of this choice. This study will explore quality of life, symptoms, cognition, frailty, performance decision making, costs and impact on carers in people with advanced chronic kidney disease managed without dialysis and is funded by the National Institute of Health Research in the UK.

METHODS: In this prospective, multicentre, longitudinal study, patients will be recruited in the UK, by renal research nurses, once they have made the decision not to embark on dialysis. Carers will be asked to 'opt-in' with consent from patients. The approach includes longitudinal quantitative surveys of quality of life, symptoms, decision making and costs for patients and quality of life and costs for carers, with questionnaires administered quarterly over 12 months. Additionally, the decision making process will be explored via qualitative interviews with renal physicians/clinical nurse specialists.

DISCUSSION: The study is designed to capture patient and carer profiles when conservative kidney management is implemented, and understand trajectories of care-receiving and care-giving with the aim of optimising palliative care for this population. It will explore the interactions that lead to clinical care decisions and the impact of these decisions on informal carers with the intention of improving clinical outcomes for patients and the experiences of care givers.

Psychosocial interventions to improve quality of life and emotional wellbeing for recently diagnosed cancer patients

BACKGROUND:
A cancer diagnosis may lead to significant psychological distress in up to 75% of cases. There is a lack of clarity about the most effective ways to address this psychological distress.
OBJECTIVES:
To assess the effects of psychosocial interventions to improve quality of life (QoL) and general psychological distress in the 12-month phase following an initial cancer diagnosis.
SEARCH METHODS:
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, Issue 4), MEDLINE, EMBASE, and PsycINFO up to January 2011. We also searched registers of clinical trials, abstracts of scientific meetings and reference lists of included studies. Electronic searches were carried out across all primary sources of peer-reviewed publications using detailed criteria. No language restrictions were imposed.
SELECTION CRITERIA:
Randomised controlled trials of psychosocial interventions involving interpersonal dialogue between a 'trained helper' and individual newly diagnosed cancer patients were selected. Only trials measuring QoL and general psychological distress were included. Trials involving a combination of pharmacological therapy and interpersonal dialogue were excluded, as were trials involving couples, family members or group formats.
DATA COLLECTION AND ANALYSIS:
Trial data were examined and selected by two authors in pairs with mediation from a third author where required. Where possible, outcome data were extracted for combining in a meta-analyses. Continuous outcomes were compared using standardised mean differences and 95% confidence intervals, using a random-effects model. The primary outcome, QoL, was examined in subgroups by outcome measurement, cancer site, theoretical basis for intervention, mode of delivery and discipline of trained helper. The secondary outcome, general psychological distress (including anxiety and depression), was examined according to specified outcome measures.
MAIN RESULTS:
A total of 3309 records were identified, examined and the trials subjected to selection criteria; 30 trials were included in the review. No significant effects were observed for QoL at 6-month follow up (in 9 studies, SMD 0.11; 95% CI -0.00 to 0.22); however, a small improvement in QoL was observed when QoL was measured using cancer-specific measures (in 6 studies, SMD 0.16; 95% CI 0.02 to 0.30). General psychological distress as assessed by 'mood measures' improved also (in 8 studies, SMD - 0.81; 95% CI -1.44 to - 0.18), but no significant effect was observed when measures of depression or anxiety were used to assess distress (in 6 studies, depression SMD 0.12; 95% CI -0.07 to 0.31; in 4 studies, anxiety SMD 0.05; 95% CI -0.13 to 0.22). Psychoeducational and nurse-delivered interventions that were administered face to face and by telephone with breast cancer patients produced small positive significant effects on QoL (in 2 studies, SMD 0.23; 95% CI 0.04 to 0.43).
AUTHORS' CONCLUSIONS:
The significant variation that was observed across participants, mode of delivery, discipline of 'trained helper' and intervention content makes it difficult to arrive at a firm conclusion regarding the effectiveness of psychosocial interventions for cancer patients. It can be tentatively concluded that nurse-delivered interventions comprising information combined with supportive attention may have a beneficial impact on mood in an undifferentiated population of newly diagnosed cancer patients.