Joanne Gray

Evaluating the Clinical Effectiveness and Cost-effectiveness of Foot Orthoses in the Treatment of Plantar Heel Pain A Feasibility Study

This study evaluated the clinical effectiveness and cost-effectiveness of two different types of foot orthoses used to treat plantar heel pain. Forty-eight patients were randomly assigned to receive either a functional or an accommodative orthosis. General (EuroQol) and specific (Foot Health Status Questionnaire) health-status measures were used. Data were also collected using economic questionnaires relating to National Health Service costs for podiatry, other health-service costs, and patient costs. Data were measured at baseline and at 4- and 8-week intervals. Thirty-five patients completed the study. The results demonstrated a significant decrease in foot pain and a significant increase in foot function with the functional foot orthoses over the 8-week trial. The accommodative foot orthoses demonstrated a significant reduction in foot pain only at 4 weeks. The cost-effectiveness analysis demonstrated that functional orthoses, although initially more expensive, result in a better quality of life. Use of functional orthoses resulted in an increased cost of pound 17.99 (32.74 dollars) per patient, leading to an incremental cost per quality-adjusted life year of pound 1,650 (3,003 dollars) for functional orthoses.

Ablative therapy for people with localised prostate cancer: a systematic review and economic evaluation.

BACKGROUND For people with localised prostate cancer, active treatments are effective but have significant side effects. Minimally invasive treatments that destroy (or ablate) either the entire gland or the part of the prostate with cancer may be as effective and cause less side effects at an acceptable cost. Such therapies include cryotherapy, high-intensity focused ultrasound (HIFU) and brachytherapy, among others. OBJECTIVES This study aimed to determine the relative clinical effectiveness and cost-effectiveness of ablative therapies compared with radical prostatectomy (RP), external beam radiotherapy (EBRT) and active surveillance (AS) for primary treatment of localised prostate cancer, and compared with RP for salvage treatment of localised prostate cancer which has recurred after initial treatment with EBRT. DATA SOURCES MEDLINE (1946 to March week 3, 2013), MEDLINE In-Process & Other Non-Indexed Citations (29 March 2013), EMBASE (1974 to week 13, 2013), Bioscience Information Service (BIOSIS) (1956 to 1 April 2013), Science Citation Index (1970 to 1 April 2013), Cochrane Central Register of Controlled Trials (CENTRAL) (issue 3, 2013), Cochrane Database of Systematic Reviews (CDSR) (issue 3, 2013), Database of Abstracts of Reviews of Effects (DARE) (inception to March 2013) and Health Technology Assessment (HTA) (inception to March 2013) databases were searched. Costs were obtained from NHS sources. REVIEW METHODS Evidence was drawn from randomised controlled trials (RCTs) and non-RCTs, and from case series for the ablative procedures only, in people with localised prostate cancer. For primary therapy, the ablative therapies were cryotherapy, HIFU, brachytherapy and other ablative therapies. The comparators were AS, RP and EBRT. For salvage therapy, the ablative therapies were cryotherapy and HIFU. The comparator was RP. Outcomes were cancer related, adverse effects (functional and procedural) and quality of life. Two reviewers extracted data and carried out quality assessment. Meta-analysis used a Bayesian indirect mixed-treatment comparison. Data were incorporated into an individual simulation Markov model to estimate cost-effectiveness. RESULTS The searches identified 121 studies for inclusion in the review of patients undergoing primary treatment and nine studies for the review of salvage treatment. Cryotherapy [3995 patients; 14 case series, 1 RCT and 4 non-randomised comparative studies (NRCSs)], HIFU (4000 patients; 20 case series, 1 NRCS) and brachytherapy (26,129 patients; 2 RCTs, 38 NRCSs) studies provided limited data for meta-analyses. All studies were considered at high risk of bias. There was no robust evidence that mortality (4-year survival 93% for cryotherapy, 99% for HIFU, 91% for EBRT) or other cancer-specific outcomes differed between treatments. For functional and quality-of-life outcomes, the paucity of data prevented any definitive conclusions from being made, although data on incontinence rates and erectile dysfunction for all ablative procedures were generally numerically lower than for non-ablative procedures. The safety profiles were comparable with existing treatments. Studies reporting the use of focal cryotherapy suggested that incontinence rates may be better than for whole-gland treatment. Data on AS, salvage treatment and other ablative therapies were too limited. The cost-effectiveness analysis confirmed the uncertainty from the clinical review and that there is no technology which appears superior, on the basis of current evidence, in terms of average cost-effectiveness. The probabilistic sensitivity analyses suggest that a number of ablative techniques are worthy of further research. LIMITATIONS The main limitations were the quantity and quality of the data available on cancer-related outcomes and dysfunction. CONCLUSIONS The findings indicate that there is insufficient evidence to form any clear recommendations on the use of ablative therapies in order to influence current clinical practice. Research efforts in the use of ablative therapies in the management of prostate cancer should now be concentrated on the performance of RCTs and the generation of standardised outcomes. STUDY REGISTRATION This study is registered as PROSPERO CRD42012002461. FUNDING The National Institute for Health Research Health Technology Assessment programme.

Systematic review of stroke thrombolysis service configuration

Intravenous recombinant tissue plasminogen activator is a highly effective treatment for acute ischemic stroke, but routine provision is challenging. We compared the activity, safety and response times of five service configurations: local services, redirection of selected or all suspected stroke patients by emergency medical services (EMS) to stroke centers and the use of telemedicine with and without secondary transfer to a stroke center. In total, 59 relevant service descriptions were identified. Pooled treatment rates (mean ± standard deviation [SD]) per 100 confirmed stroke patients were: local service design, 2.5 ± 2.5 (n = 21417); EMS redirection of only patients potentially eligible for thrombolysis, 3.9 ± 1.2 (n = 1872); EMS redirection of all suspected stroke patients, 3.8 ± 1.1 (n = 5427); telemedicine with secondary transfer, 6.9 (no pooled SD; n = 749); and telemedicine without secondary transfer, 3.4 (no pooled SD; n = 6610). A comprehensive stroke patient register was completed for only five regional collaborations, resulting in pooled ischemic stroke treatment rates of 5.7 (95% confidence interval: 4.6–6.9; n = 7815) compared with 3.1 (95% confidence interval: 2.1–4.1; n = 31411) for local services. Pooled symptomatic hemorrhage rates were similar for all service designs (range: 3.9–5.1%). Average door–needle times exceeded 60 min in most studies. We conclude that regional collaborations achieve higher rates of thrombolysis than local services working in isolation. Stroke services should continue to publish thrombolysis activity and safety data in a recommended format in order to determine the most suitable configuration for different settings.

First estimates of the potential cost and cost saving of protecting childhood hearing from damage caused by congenital CMV infection

Background Congenital cytomegalovirus (cCMV) is an important cause of childhood deafness, which is modifiable if diagnosed within the first month of life. Targeted screening of infants who do not pass their newborn hearing screening tests in England is a feasible approach to identify and treat cases to improve hearing outcome. Aims To conduct a cost analysis of targeted screening and subsequent treatment for cCMV-related sensorineural hearing loss (SNHL) in an, otherwise, asymptomatic infant, from the perspective of the UK National Health Service (NHS). Methods Using data from the newborn hearing screening programme (NHSP) in England and a recent study of targeted screening for cCMV using salivary swabs within the NHSP, we estimate the cost (in UK pounds (£)) to the NHS. The cost of screening (time, swabs and PCR), assessing, treating and following up cases is calculated. The cost per case of preventing hearing deterioration secondary to cCMV with targeted screening is calculated. Results The cost of identifying, assessing and treating a case of cCMV-related SNHL through targeted cCMV screening is estimated to be £6683. The cost of improving hearing outcome for an infant with cCMV-related SNHL through targeted screening and treatment is estimated at £14 202. Conclusions The costs of targeted screening for cCMV using salivary swabs integrated within NHSP resulted in an estimate of cost per case that compares favourably with other screening programmes. This could be used in future studies to estimate the full economic value in terms of incremental costs and incremental health benefits.

High-intensity interval exercise training before abdominal aortic aneurysm repair (HIT-AAA): protocol for a randomised controlled feasibility trial

Introduction In patients with large abdominal aortic aneurysm (AAA), open surgical or endovascular aneurysm repair procedures are often used to minimise the risk of aneurysm-related rupture and death; however, aneurysm repair itself carries a high risk. Low cardiopulmonary fitness is associated with an increased risk of early post-operative complications and death following elective AAA repair. Therefore, fitness should be enhanced before aneurysm repair. High-intensity interval exercise training (HIT) is a potent, time-efficient strategy for enhancing cardiopulmonary fitness. Here, we describe a feasibility study for a definitive trial of a pre-operative HIT intervention to improve post-operative outcomes in patients undergoing elective AAA repair. Methods and analysis A minimum of 50 patients awaiting elective repair of a 5.5–7.0 cm infrarenal AAA will be allocated by minimisation to HIT or usual care control in a 1:1 ratio. The patients allocated to HIT will complete three hospital-based exercise sessions per week, for 4 weeks. Each session will include 2 or 4 min of high-intensity stationary cycling followed by the same duration of easy cycling or passive recovery, repeated until a total of 16 min of high-intensity exercise is accumulated. Outcomes to be assessed before randomisation and 24–48 h before aneurysm repair include cardiopulmonary fitness, maximum AAA diameter and health-related quality of life. In the post-operative period, we will record destination (ward or critical care unit), organ-specific morbidity, mortality and the durations of critical care and hospital stay. Twelve weeks after the discharge, participants will be interviewed to reassess quality of life and determine post-discharge healthcare utilisation. The costs associated with the exercise intervention and healthcare utilisation will be calculated. Ethics and dissemination Ethics approval was secured through Sunderland Research Ethics Committee. The findings of the trial will be disseminated through peer-reviewed journals, and national and international presentations. Trial registration Current Controlled Trials ISRCTN09433624.

Can Automated Imaging for Optic Disc and Retinal Nerve Fiber Layer Analysis Aid Glaucoma Detection

Purpose To compare the diagnostic performance of automated imaging for glaucoma. Design Prospective, direct comparison study. Participants Adults with suspected glaucoma or ocular hypertension referred to hospital eye services in the United Kingdom. Methods We evaluated 4 automated imaging test algorithms: the Heidelberg Retinal Tomography (HRT; Heidelberg Engineering, Heidelberg, Germany) glaucoma probability score (GPS), the HRT Moorfields regression analysis (MRA), scanning laser polarimetry (GDx enhanced corneal compensation; Glaucoma Diagnostics (GDx), Carl Zeiss Meditec, Dublin, CA) nerve fiber indicator (NFI), and Spectralis optical coherence tomography (OCT; Heidelberg Engineering) retinal nerve fiber layer (RNFL) classification. We defined abnormal tests as an automated classification of outside normal limits for HRT and OCT or NFI ≥ 56 (GDx). We conducted a sensitivity analysis, using borderline abnormal image classifications. The reference standard was clinical diagnosis by a masked glaucoma expert including standardized clinical assessment and automated perimetry. We analyzed 1 eye per patient (the one with more advanced disease). We also evaluated the performance according to severity and using a combination of 2 technologies. Main Outcome Measures Sensitivity and specificity, likelihood ratios, diagnostic, odds ratio, and proportion of indeterminate tests. Results We recruited 955 participants, and 943 were included in the analysis. The average age was 60.5 years (standard deviation, 13.8 years); 51.1% were women. Glaucoma was diagnosed in at least 1 eye in 16.8%; 32% of participants had no glaucoma-related findings. The HRT MRA had the highest sensitivity (87.0%; 95% confidence interval [CI], 80.2%–92.1%), but lowest specificity (63.9%; 95% CI, 60.2%–67.4%); GDx had the lowest sensitivity (35.1%; 95% CI, 27.0%–43.8%), but the highest specificity (97.2%; 95% CI, 95.6%–98.3%). The HRT GPS sensitivity was 81.5% (95% CI, 73.9%–87.6%), and specificity was 67.7% (95% CI, 64.2%–71.2%); OCT sensitivity was 76.9% (95% CI, 69.2%–83.4%), and specificity was 78.5% (95% CI, 75.4%–81.4%). Including only eyes with severe glaucoma, sensitivity increased: HRT MRA, HRT GPS, and OCT would miss 5% of eyes, and GDx would miss 21% of eyes. A combination of 2 different tests did not improve the accuracy substantially. Conclusions Automated imaging technologies can aid clinicians in diagnosing glaucoma, but may not replace current strategies because they can miss some cases of severe glaucoma.

The potential value of priority-setting methods in public health investment decisions: qualitative findings from three English local authorities

Abstract This paper reports on an action-oriented research study providing decision support to three local authorities in England on the prioritisation of public health investment and disinvestment decisions. We adopted a political science perspective, using the multiple streams framework to investigate the use of prioritisation tools in public health spending decisions at a time of severe financial constraints. The challenges and implications of their potential use in everyday practice were explored. Twenty-nine interviews were conducted before the targeted decision support occurred and 19 interviews after the decision support had been delivered. Interviews were held with locally elected politicians, officers and public health professionals based within local government, NHS commissioners and the local independent consumer watchdog for health and social care. Targeted workshops with local stakeholders were facilitated in each site by health economist members of the project team. Structured observational notes were recorded during these workshops and integrated with the interview data. Many respondents expressed an interest in prioritisation tools although some scepticism was expressed about their value and impact on decision-making. This paper analyses the enablers and barriers to adopting priority-setting tools in a local government environment that by definition is political. The findings suggest that the adoption of priority-setting tools in decision-making processes in public health poses some significant challenges within local government and that certain enabling factors have to be present.

An observational study of patient characteristics associated with the mode of admission to acute stroke services in North East, England

Objective Effective provision of urgent stroke care relies upon admission to hospital by emergency ambulance and may involve pre-hospital redirection. The proportion and characteristics of patients who do not arrive by emergency ambulance and their impact on service efficiency is unclear. To assist in the planning of regional stroke services we examined the volume, characteristics and prognosis of patients according to the mode of presentation to local services. Study design and setting A prospective regional database of consecutive acute stroke admissions was conducted in North East, England between 01/09/10-30/09/11. Case ascertainment and transport mode were checked against hospital coding and ambulance dispatch databases. Results Twelve acute stroke units contributed data for a mean of 10.7 months. 2792/3131 (89%) patients received a diagnosis of stroke within 24 hours of admission: 2002 arrivals by emergency ambulance; 538 by private transport or non-emergency ambulance; 252 unknown mode. Emergency ambulance patients were older (76 vs 69 years), more likely to be from institutional care (10% vs 1%) and experiencing total anterior circulation symptoms (27% vs 6%). Thrombolysis treatment was commoner following emergency admission (11% vs 4%). However patients attending without emergency ambulance had lower inpatient mortality (2% vs 18%), a lower rate of institutionalisation (1% vs 6%) and less need for daily carers (7% vs 16%). 149/155 (96%) of highly dependent patients were admitted by emergency ambulance, but none received thrombolysis. Conclusion Presentations of new stroke without emergency ambulance involvement were not unusual but were associated with a better outcome due to younger age, milder neurological impairment and lower levels of pre-stroke dependency. Most patients with a high level of pre-stroke dependency arrived by emergency ambulance but did not receive thrombolysis. It is important to be aware of easily identifiable demographic groups that differ in their potential to gain from different service configurations.

Clinical effectiveness and cost-effectiveness of foot orthoses for people with established rheumatoid arthritis: an exploratory clinical trial.

Objectives: Foot orthoses are commonly prescribed as an intervention for people with rheumatoid arthritis (RA). Data relating to the cost-effectiveness of foot orthoses in people with RA are limited. The aim was to evaluate the clinical and cost-effectiveness of two types of foot orthoses in people with established RA. Method: A single-blind randomized controlled trial was undertaken to compare custom-made foot orthoses (CMFOs) and simple insoles (SIs) in 41 people with established RA. The Foot Function Index (FFI) was used to measure foot pain, disability, and functional limitation. Costs were estimated from the perspective of the UK National Health Service (NHS), societal (patient and family) perspective, and secondary care resource use in terms of the intervention and staff time. Effects were assessed in terms of health gain expressed as quality-adjusted life years (QALYs). Results: At baseline, 20 participants received a CMFO and 21 participants received an SI. After 16 weeks foot pain improved in both the CMFOs (p = 0.000) and the SIs (p < 0.01). However, disability scores improved for CMFOs (p < 0.001) but not for SIs (p = 0.40). The cost-effectiveness results demonstrated no difference in cost between the arms (CMFOs: £159.10; SIs: £79.10; p = 0.35), with the CMFOs being less effective in terms of cost per QALY gain (p < 0.001). Conclusions: In people with established RA, semi-rigid customized foot orthoses can improve pain and disability scores in comparison to simple insoles. From a cost-effectiveness perspective, the customized foot orthoses were far more expensive to manufacture, with no significant cost per QALY gain.

The ETTAA study protocol: a UK-wide observational study of 'Effective Treatments for Thoracic Aortic Aneurysm'.

Introduction Chronic thoracic aortic aneurysm (CTAA) affecting the arch or descending aorta is an indolent but life-threatening condition with a rising prevalence as the UK population ages. Treatment may be in the form of open surgical repair (OSR) surgery, endovascular stent grafting (ESG) or best medical therapy (BMT). Currently, there is no consensus on the best management strategy, and no UK-specific economic studies that assess outcomes beyond the chosen procedure, but this is required in the context of greater demand for treatment and limited National Health Service (NHS) resources. Methods and analysis This is a prospective, multicentre observational study with statistical and economic modelling of patients with CTAA affecting the arch or descending aorta. We aim to gain an understanding of how treatments are currently chosen, and to determine the clinical effectiveness and cost-effectiveness of the three available treatment strategies (BMT, ESG and OSR). This will be achieved by: (1) following consecutive patients who are referred to the teams collaborating in this proposal and collecting data regarding quality of life (QoL), medical events and hospital stays over a maximum of 5 years; (2) statistical analysis of the comparative effectiveness of the three treatments; and (3) economic modelling of the comparative cost-effectiveness of the three treatments. Primary study outcomes are: aneurysm growth, QoL, freedom from reintervention, freedom from death or permanent neurological injury, incremental cost per quality-adjusted life year gained. Ethics and dissemination The study will generate an evidence base to guide patients and clinicians to determine the indications and timing of treatment, as well as informing healthcare decision-makers about which treatments the NHS should provide. The study has achieved ethical approval and will be disseminated primarily in the form of a Health Technology Assessment monograph at its completion. Trial registration number ISRCTN04044627.