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Primary angle-closure glaucoma is a leading cause of irreversible blindness worldwide. In early-stage disease, intraocular pressure is raised without visual loss. Because the crystalline lens has a major mechanistic role, lens extraction might be a useful initial treatment. From Jan 8, 2009, to Dec 28, 2011, we enrolled patients from 30 hospital eye services in five countries. Randomisation was done by a web-based application. Patients were assigned to undergo clear-lens extraction or receive standard care with laser peripheral iridotomy and topical medical treatment. Eligible patients were aged 50 years or older, did not have cataracts, and had newly diagnosed primary angle closure with intraocular pressure 30 mm Hg or greater or primary angle-closure glaucoma. The co-primary endpoints were patient-reported health status, intraocular pressure, and incremental cost-effectiveness ratio per quality-adjusted life-year gained 36 months after treatment. Analysis was by intention to treat. This study is registered, number ISRCTN44464607. Of 419 participants enrolled, 155 had primary angle closure and 263 primary angle-closure glaucoma. 208 were assigned to clear-lens extraction and 211 to standard care, of whom 351 (84%) had complete data on health status and 366 (87%) on intraocular pressure. The mean health status score (0·87 [SD 0·12]), assessed with the European Quality of Life-5 Dimensions questionnaire, was 0·052 higher (95% CI 0·015–0·088, p=0·005) and mean intraocular pressure (16·6 [SD 3·5] mm Hg) 1·18 mm Hg lower (95% CI –1·99 to –0·38, p=0·004) after clear-lens extraction than after standard care. The incremental cost-effectiveness ratio was £14 284 for initial lens extraction versus standard care. Irreversible loss of vision occurred in one participant who underwent clear-lens extraction and three who received standard care. No patients had serious adverse events. Clear-lens extraction showed greater efficacy and was more cost-effective than laser peripheral iridotomy, and should be considered as an option for first-line treatment. Medical Research Council.

The aim of this study was to estimate the economic burden of diabetes mellitus (DM) in Iran from 2009 to 2030. A Markov micro-simulation (MM) model was developed to predict the DM population size and associated economic burden. Age- and sex-specific prevalence and incidence of diagnosed and undiagnosed DM were derived from national health surveys. A systematic review was performed to identify the cost of diabetes in Iran and the mean annual direct and indirect costs of patients with DM were estimated using a random-effect Bayesian meta-analysis. Face, internal, cross and predictive validity of the MM model were assessed by consulting an expert group, performing sensitivity analysis (SA) and comparing model results with published literature and national survey reports. Sensitivity analysis was also performed to explore the effect of uncertainty in the model. We estimated 3.78 million cases of DM (2.74 million diagnosed and 1.04 million undiagnosed) in Iran in 2009. This number is expected to rise to 9.24 million cases (6.73 million diagnosed and 2.50 million undiagnosed) by 2030. The mean annual direct and indirect costs of patients with DM in 2009 were US$ 556 (posterior standard deviation, 221) and US$ 689 (619), respectively. Total estimated annual cost of DM was $3.64 (2009 US$) billion (including US$1.71 billion direct and US$1.93 billion indirect costs) in 2009 and is predicted to increase to $9.0 (in 2009 US$) billion (including US$4.2 billion direct and US$4.8 billion indirect costs) by 2030. The economic burden of DM in Iran is predicted to increase markedly in the coming decades. Identification and implementation of effective strategies to prevent and manage DM should be considered as a public health priority.

The aim of this study was to measure health-related quality of life (HRQoL) in Iranian people with Type 2 Diabetes Mellitus using two different measures and examines which socio-demographic and diabetes-related characteristics are associated with better quality of life based on a nationally distributed sample. A multi-stage cluster sampling method was used to select 3472 subjects as a part of Iranian surveillance of risk factors of non-communicable disease (ISRFNCD). EuroQol-5 Dimensions questionnaire (EQ-5D) and Visual Analog Scale (VAS) were employed to measure HRQoL. Binary logistic and Tobit regression models were used to investigate factors associated with EQ-5D results. The mean age of subjects was 59.4 years (SD = 11.7), 61.3% were female and had 8.08 years (SD = 6.7) known duration of diabetes. The patients reported \"some or extreme problems\" most frequently in Pain/Discomfort (69.3%) and Anxiety/Depression (56.6%) dimensions of EQ-5D. The mean EQ-5D and VAS score were 0.70 (95% CI 0.69-0.71) and 56.8 (95% CI 56.15-57.5) respectively. Female gender, lower education, unemployment, long duration of diabetes, diabetes-related hospitalization in past years and having nephropathy and lower extremity lesions were associated with higher probabilities of reporting \"some or extreme problems\" in most dimensions of EQ-5D in binary logistic regression models. The same factors in addition to retinopathy were significantly associated with lower levels of HRQoL in Tobit regression analysis too. The study findings indicate that patients with diabetes in Iran suffer from relatively poor HRQoL. Therefore much more attention should be paid to main determinants of HRQoL to identify and implement appropriate policies for achieving better management of diabetes and ultimately improving the quality of life of diabetic patients in this region.

Diabetes is a worldwide high prevalence chronic progressive disease that poses a significant challenge to healthcare systems. The aim of this study is to provide a detailed economic burden of diagnosed type 2 diabetes mellitus (T2DM) and its complications in Iran in 2009 year. This is a prevalence-based cost-of-illness study focusing on quantifying direct health care costs by bottom-up approach. Data on inpatient hospital services, outpatient clinic visits, physician services, drugs, laboratory test, education and non-medical cost were collected from two national registries. The human capital approach was used to calculate indirect costs separately in male and female and also among different age groups. The total national cost of diagnosed T2DM in 2009 is estimated at 3.78 billion USA dollars (USD) including 2.04±0.28 billion direct (medical and non-medical) costs and indirect costs of 1.73 million. Average direct and indirect cost per capita was 842.6±102 and 864.8 USD respectively. Complications (48.9%) and drugs (23.8%) were main components of direct cost. The largest components of medical expenditures attributed to diabetes's complications are cardiovascular disease (42.3% of total Complications cost), nephropathy (23%) and ophthalmic complications (14%). Indirect costs include temporarily disability (335.7 million), permanent disability (452.4 million) and reduced productivity due to premature mortality (950.3 million). T2DM is a costly disease in the Iran healthcare system and consume more than 8.69% of total health expenditure. In addition to these quantified costs, T2DM imposes high intangible costs on society in terms of reduced quality of life. Identification of effective new strategies for the control of diabetes and its complications is a public health priority.

BackgroundNon-ST-elevation myocardial infarction (NSTEMI) is the most common type of heart attack in the UK and it is becoming increasingly prevalent among older people. An early invasive treatment strategy may be effective and cost-effective for treating NSTEMI but evidence is currently unclear.ObjectivesTo assess the cost-effectiveness of the early invasive strategy versus medical management in elderly patients with NSTEMI and to provide guidance for future research in this area.MethodsA long-term Markov state transition model was developed. Model inputs were systematically derived from a number of sources most appropriate to a UK relevant analysis, such as published studies and national routine data. Costs were estimated from the perspective of National Health Service and Personal Social Services. The model was developed using TreeAge Pro software. Based on a probabilistic sensitivity analysis, a value of information analysis was carried out to establish the value of decision uncertainty both overall and for specific input parameters.ResultsIn 2017 UK £, the incremental cost-effectiveness ratio of the early invasive strategy was £46 916 for each additional quality-adjusted life-year (QALY) gained, with a probability of being cost-effective of 23% at a cost-effectiveness threshold of £20 000/QALY. There was a considerable decision uncertainty with these results. The value of removing all this uncertainty was up to £1 920 000 annually. Most uncertainty related to clinical effectiveness parameters and the optimal study design to remove this uncertainty would be a randomised controlled trial.ConclusionBased on current evidence, the early invasive strategy is not likely to be cost-effective for elderly patients with NSTEMI. This conclusion should be interpreted with caution mainly due to the absence of NSTEMI-specific data and long-term clinical effectiveness estimates.

ObjectivesStress urinary incontinence (SUI) and stress-predominant mixed urinary incontinence (MUI) are common conditions that can have a negative impact on the quality of life of patients and serious cost implications for healthcare providers. The objective of this study was to assess the cost-effectiveness of nine different surgical interventions for treatment of SUI and stress-predominant MUI from a National Health Service and personal social services perspective in the UK.MethodsA Markov microsimulation model was developed to compare the costs and effectiveness of nine surgical interventions. The model was informed by undertaking a systematic review of clinical effectiveness and network meta-analysis. The main clinical parameters in the model were the cure and incidence rates of complications after different interventions. The outcomes from the model were expressed in terms of cost per quality-adjusted life-years (QALYs) gained. In addition, expected value of perfect information (EVPI) analyses were conducted to quantify the main uncertainties facing decision-makers.ResultsThe base-case results suggest that retropubic mid-urethral sling (retro-MUS) is the most cost-effective surgical intervention over a 10-year and lifetime time horizon. The probabilistic results show that retro-MUS and traditional sling are the interventions with the highest probability of being cost-effective across all willingness-to-pay thresholds over a lifetime time horizon. The value of information analysis results suggest that the largest value appears to be in removing uncertainty around the incidence rates of complications, the relative treatment effectiveness and health utility values.ConclusionsAlthough retro-MUS appears, at this stage, to be a cost-effective intervention, research is needed on possible long-term complications of all surgical treatments to provide reassurance of safety, or earlier warning of unanticipated adverse effects. The value of information analysis supports the need, as a first step, for further research to improve our knowledge of the actual incidence of complications.

Background. Consensus on standardized active surveillance or follow-up care by clinicians is lacking leading to considerable variation in practice across countries. An important structural modelling consideration is that self-examination by patients and their partners can detect melanoma recurrence outside of active surveillance regimes. Objectives. To identify candidate melanoma surveillance strategies for American Joint Committee on Cancer (AJCC) stage I disease and compare them with the current recommended practice in a cost-utility analysis framework. Methods. In consultation with UK clinical experts, a microsimulation model was built in TreeAge Pro 2019 R1.0 (Williamstown, MA, USA) to evaluate surveillance strategies for AJCC stage IA and IB melanoma patients separately. The model incorporated patient behaviors such as self-detection and emergency visits to examine suspicious lesions. A National Health Service (NHS) perspective was taken. Model input parameters were taken from the literature and where data were not available, local expert opinion was sought. Probabilistic sensitivity analysis, one-way sensitivity analysis on pertinent parameters and value of information was performed. Results. In the base-case probabilistic sensitivity analysis, less intensive surveillance strategies for AJCC stage IA and IB had lower total lifetime costs than the current National Institute for Health and Care Excellence (NICE) recommended strategy with similar effectiveness in terms of quality-adjusted life years and thereby likely to be cost-effective. Many strategies had similar effectiveness due to the relatively low chance of recurrence and the high rate of self-detection. Sensitivity and scenario analyses did not change these findings. Conclusions. Our model findings suggest that less resource intensive surveillance may be cost-effective compared with the current NICE surveillance guidelines. However, to advocate convincingly for changes, better evidence is required.

Contrast-associated acute kidney injury (CA-AKI) is an important adverse effect associated with injecting iodinated intra-arterial contrast media (CM) during coronary angiography. The DyeVert™ Contrast Reduction System is a medical device intended to reduce the intra-arterial CM volume (CMV) administered. The aim of this study was to assess DyeVert System clinical effectiveness and safety by implementing a systematic review and meta-analysis of existing evidence. Systematic electronic literature searches were conducted in MEDLINE, Embase, the Cochrane Database of Systematic Reviews, ClinicalTrials.gov, and the International Clinical Trials Registry Platform database. Relevant data were extracted from included studies and meta-analyses were performed to synthesize evidence across studies. The review included 17 eligible studies involving 1,731 DyeVert System cases and 1,387 control cases (without the use of DyeVert). Meta-analyses demonstrated use of the DyeVert System reduced CMV delivered to the patient by 39.27% (95% CI, 36.10-42.48%, < 0.001), reduced CMV/baseline renal function ratios (Hedges's g, -0.56; 95% CI, -0.70 to -0.42, < 0.001) and percentage of cases exceeding the maximum CMV threshold (risk difference -0.31, 95% CI, -0.48 to -0.13, < 0.001) while maintaining adequate image quality in 98% of cases. DyeVert System cases demonstrated lower CA-AKI incidence vs. controls (absolute risk reduction 5.00% (95% CI, 0.40-9.80%; = 0.03), relative risk 0.60 (95% CI, 0.40-0.90; = 0.01) with a pooled estimate of the number needed to treat with the DyeVert System to avoid 1 CA-AKI event of 20. DyeVert System use significantly reduces CMV delivered to the patient, CMV/baseline renal function ratios, and CA-AKI incidence while maintaining image quality. Accordingly, the device may serve as an adjunctive, procedure-based strategy to prevent CA-AKI. Future multi-center studies are needed to further assess effects of minimizing CMV on endpoints such as CA-AKI prevention, incidence of adverse cardiac and renal events, and health care costs.

Background Surgical interventions for the treatment of stress urinary incontinence (SUI) in women are commonly employed following the failure of minimally invasive therapies. Due to the limited information available on the relative cost-effectiveness of available surgeries for treating SUI, a de novo economic analysis was conducted to assess costs and effects of all relevant surgeries. To inform the economic analysis, the objective of this review was to identify and assess the quality of existing economic evaluation studies on different surgical interventions for the treatment of SUI in women. Methods The following databases were searched during the review process: Medical Literature Analysis and Retrieval System Online (MEDLINE), MEDLINE In-Process, Excerpta Medica Database (Embase), National Health Service Economic Evaluation Database (NHS EED), and Health Management Information Consortium and Cost-Effectiveness Analysis Registry (CEA registry). The key criteria for inclusion were that the study population included women with SUI and that the surgical interventions considered were utilised as either a primary or a follow-up surgery. The review included only full economic evaluations. Studies were quality assessed using the Drummond checklist for economic evaluations. No quantitative synthesis of the results by meta-analysis was conducted due to the high methodological heterogeneity. Results Twenty-six economic evaluations were included, of which 13 were model-based analyses. Surgical treatments assessed most frequently were mid-urethral slings and open and laparoscopic colposuspension. There were some differences in the methodological approaches taken, including differences in type of economic analysis, perspective, time horizon, types of resource use, and costs and outcomes that were included in the analysis. The majority of studies conducted a cost-utility analysis from a health system perspective and applied a time horizon of between 1 and 5 years. The cost-effectiveness results suggest that single-incision mini-sling and mid-urethral slings are among the most cost-effective options. Conclusions The review has shown that methods used for the economic evaluation of surgical treatments for SUI vary widely in terms of study design, analysis type, compared alternatives, time horizon, costing methodologies and effect outcomes. Future economic evaluation studies on surgical treatments for SUI may be improved by the application of available guidelines. Systematic review registration Registered in PROSPERO in 2016, CRD42016049339

Background Despite evidence from clinical trials that intravenous (IV) thrombolysis is a cost-effective treatment for selected acute ischaemic stroke patients, there remain large variations in the rate of IV thrombolysis delivery between stroke services. This study is evaluating whether an enhanced care pathway delivered by paramedics (the Paramedic Acute Stroke Treatment Assessment (PASTA)) could increase the number of patients who receive IV thrombolysis treatment. Methods Study design: Cluster randomised trial with economic analysis and parallel process evaluation. Setting: National Health Service ambulance services, emergency departments and hyper-acute stroke units within three geographical regions of England and Wales. Randomisation: Ambulance stations within each region are the units of randomisation. According to station allocation, paramedics based at a station deliver the PASTA pathway (intervention) or continue with standard stroke care (control). Study intervention: The PASTA pathway includes structured pre-hospital information collection, prompted pre-notification, structured handover of information in hospital and assistance with simple tasks during the initial hospital assessment. Study-trained intervention group paramedics deliver this pathway to adults within 4 h of suspected stroke onset. Study control: Standard stroke care according to national and local guidelines for the pre-hospital and hospital assessment of suspected stroke. Participants: Participants enrolled in the study are adults with confirmed stroke who were assessed by a study paramedic within 4 h of symptom onset. Primary outcome: Proportion of participants receiving IV thrombolysis. Sample size: 1297 participants provide 90% power to detect a 10% difference in the proportion of patients receiving IV thrombolysis. Discussion The results from this trial will determine whether an enhanced care pathway delivered by paramedics can increase thrombolysis delivery rates. Trial registration ISRCTN registry, ISRCTN12418919 . Registered on 5 November 2015.