Cost-Utility Analysis of the Caresyntax Platform to Identify Patients at Risk of Surgical Site Infection Undergoing Colorectal Surgery.

BACKGROUND: Surgical site infections (SSIs) account for up to 18% of all healthcare-associated infections (HAIs). The Caresyntax data-driven surgery platform incorporates the most common risk factors for SSI, to identify high-risk surgical patients before they leave the operating theatre and treat them prophylactically with negative pressure wound therapy (NPWT). An economic analysis was performed to assess the costs and health outcomes associated with introduction of the technology in the English healthcare setting. METHODS: A hybrid decision tree/Markov model was developed to reflect the treatment pathways that patients undergoing colorectal surgery would typically follow, both over the short term (30-day hospital setting) and long term (lifetime). The analysis considered implementation of Caresyntax's platform-based SSI predictive algorithm in the hospital setting, compared with standard of care, from an English National Health Service (NHS) perspective. The base-case analysis presents results in terms of cost per quality-adjusted life-year (QALY) gained, as well as operational impact. RESULTS: The base-case analysis indicates that the intervention leads to a cost saving of £55.52m across the total NHS colorectal surgery patient population in 1 year. In addition, the intervention has a 98.36% probability of being cost effective over a lifetime horizon. The intervention results in the avoidance of 19,744 SSI events, as well 191,911 excess hospital bed days saved. CONCLUSION: Caresyntax's platform-based SSI predictive algorithm has the potential to result in cost savings and improved patient quality of life. Additionally, operational gains for the healthcare provider, including reduced infection rates and hospital bed days saved, have been shown through the economic modeling.

Cost-Effectiveness Analysis of Intravascular Targeted Temperature Management after Cardiac Arrest in England.

BACKGROUND: Targeted temperature management (TTM) has been shown to improve neurological outcomes and survival in patients resuscitated from cardiac arrest; however, the cost effectiveness of multiple TTM methods is not well studied. OBJECTIVE: This study aimed to evaluate the cost effectiveness of intravascular temperature management (IVTM) using Thermogard XP compared with surface cooling methods after cardiac arrest in the England from the perspectives of the UK national health service and Personal Social Services. METHODS: We developed a multi-state Markov model that evaluated IVTM (Thermogard XP) compared with surface cooling using two different devices (Blanketrol III and Arctic Sun 5000) over a short-term and lifetime time horizon. Model input parameters were obtained from the literature and local databases. We assumed a hypothetical cohort of 1000 patients who required TTM after cardiac arrest per year in the England. The outcomes were costs (in £, year 2019 values) and quality-adjusted life-years (QALYs), discounted at 3.5% annually. Deterministic and probabilistic sensitivity analyses were undertaken to examine the effect of alternative assumptions and uncertainty in model parameters on the results. RESULTS: The cost-effectiveness analysis determined that Thermogard XP resulted in direct cost savings of £2339 and £2925 (per patient) compared with Blanketrol III and Arctic Sun 5000, respectively, and a gain of 0.98 QALYs over the patient lifetime. The probabilistic sensitivity analysis demonstrated that the probability of Thermogard XP being cost saving would be 69.2% and 65.3% versus the Arctic Sun 5000 and Blanketrol III, respectively. CONCLUSION: Implementation of IVTM using Thermogard XP can lead to cost savings and improved patient quality of life versus surface cooling methods.

DyeVert Contrast Reduction System Use in Patients Undergoing Coronary and/or Peripheral Angiography: A Systematic Literature Review and Meta-Analysis.

Background: 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. Methods: 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. Results: 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%, P < 0.001), reduced CMV/baseline renal function ratios (Hedges's g, -0.56; 95% CI, -0.70 to -0.42, P < 0.001) and percentage of cases exceeding the maximum CMV threshold (risk difference -0.31, 95% CI, -0.48 to -0.13, P < 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%; P = 0.03), relative risk 0.60 (95% CI, 0.40-0.90; P = 0.01) with a pooled estimate of the number needed to treat with the DyeVert System to avoid 1 CA-AKI event of 20. Conclusion: 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.

Cost-Effectiveness Analysis of a Medial Meniscus Replacement Prosthesis for the Treatment of Patients with Medial Compartment Pain in the United Kingdom.

BACKGROUND: The most common intra-articular knee injury is a meniscal tear, which commonly occurs secondary to trauma following twisting or hyperflexion. Treatment options for meniscal tears can either be surgical or non-surgical, and range from rest, exercise, bracing and physical therapy to surgical intervention, including meniscal repair and partial meniscectomy. In patients with persistent pain following loss of meniscus tissue, treatment can include partial replacement or meniscal allograft transplantation. The NUsurface® prosthesis has been developed as a treatment option for patients experiencing persistent knee pain post medial meniscus (MM) surgery. OBJECTIVE: The aim of this study was to assess the cost effectiveness of MM replacement using NUsurface for the treatment of patients with medial compartment pain following previous partial medial meniscectomy, from a UK health service perspective. METHODS: An economic decision-analytic model was developed to assess the cost per quality-adjusted life-year (QALY) gained associated with the introduction of MM replacement using NUsurface compared with non-surgical standard of care, over a lifetime time horizon. The model structure was primarily informed by a previous clinical trial (VENUS) and was developed based on the clinical pathways typically followed by patients with this condition, with treatment pathways and probabilities of clinical progression adjusted depending on whether patients were receiving the intervention or undergoing current practice. A hypothetical cohort of adult patients (mean age of 50 years) was modelled, with clinical data sourced from the VENUS study as well as relevant UK literature. Both deterministic and probabilistic sensitivity analyses were carried out to explore uncertainty in the model results. RESULTS: The base-case probabilistic results indicate that MM replacement using NUsurface is likely to be cost effective across a range of willingness-to-pay (WTP) thresholds (95% probability of being cost effective at the National Institute for Health and Care Excellence (NICE)-recommended £20,000 WTP threshold). Although per-patient costs increase, QALYs are also gained, with the incremental cost per QALY (probabilistic value = £5011) being below £20,000. Deterministic sensitivity analyses indicate that the parameters that have the greatest impact on results are the failure rate in the control group (current practice), utility scores, and the cost of undergoing MM replacement using NUsurface. CONCLUSIONS: Based on the analysis presented, MM replacement with the NUsurface prosthetic implant is likely to be a cost-effective use of UK health care service resources compared with current standard care.

Budget Impact of the Vest™ High Frequency Chest Wall Oscillation System for Managing Airway Clearance in Patients with Complex Neurological Disorders: A US Healthcare Payers' Perspective Analysis.

OBJECTIVE: As a recognized therapy to improve airway clearance, high-frequency chest wall oscillation (HFCWO) is used to manage reduced vital capacity in patients with complex neuromuscular disorders (cNMD). This study aimed to investigate the budget impact of HFCWO versus chest wall physical therapy (CWPT) from a US-commercial payer perspective. METHODS: In combination with a previously developed cost-effectiveness model, a budget impact model was developed to evaluate the incremental budgetary impact associated with introducing a HFCWO device over a 5-year time horizon. The model compared the cost implications associated with the commonly used CWPT procedure, as the current scenario, with a new scenario consisting of 80% of market share for HFCWO. The resource use and costs included in the analyses were costs associated with the HFCWO device (Vest™ System) and its consumables, patient training, and medical services such as hospitalization, medications, emergency room, and outpatient visits. The primary outcome measures included total and incremental budgetary impact per member per year (PMPY). RESULTS: In a hypothetical plan of 1,000,000 members (men: 49.2%), 2099 patients with cNMD were estimated to be eligible to receive airway clearance services over 5 years. The new scenario (HFCWO and CWPT [US$24 PMPY]) was cost-saving compared with the current scenario (CWPT only [$34 PMPY]) with a cost reduction of US$9.46 PMPY. The model estimated a net cost-saving of US$1,594,131 and US$9,591,343 over 1 and 5 years, respectively. CONCLUSION: This study suggests the HFCWO technique to manage the reduction in vital capacity in patients with cNMD would lead to favorable budget impact results.

Cost-effectiveness analysis of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in patients with gastric cancer and peritoneal metastasis.

OBJECTIVE: The aim of this study was to assess the cost-effectiveness of pressurized intraperitoneal aerosol chemotherapy with low-dose cisplatin and doxorubicin (PIPAC C/D) for the treatment of advanced gastric cancer. METHODS: A Partitioned Survival Model followed by state transition Markov model was developed to estimate the costs and effectiveness of the use of PIPAC C/D versus palliative chemotherapy in the UK. The intervention was assessed at two different levels of care, including upfront therapy (PIPAC C/D plus Oxaliplatin in combination with Capecitabine (XELOX) chemotherapy versus first-line chemotherapy alone) and second-line therapy (PIPAC C/D alone versus second-line chemotherapy (ramucirumab monotherapy)). Data from multiple sources, including published literature and UK-based databases, were used to inform the economic model. RESULTS: For the upfront therapy analysis, the estimated total costs in the intervention and comparator arms were £32,606 (SD: £3877) and £17,844 (SD: £920), respectively. PIPAC C/D plus XELOX led to an increase of 0.46 in quality-adjusted life-years (QALYs) gained. The incremental cost per QALY gained was £31,868. For the second-line therapy analysis, the use of PIPAC C/D led to an increase of 0.19 in QALYs and a £21,474 reduction in costs, meaning the intervention was a dominant strategy. CONCLUSIONS: The cost-effectiveness results for the upfront therapy analysis indicate that PIPAC C/D plus chemotherapy is a cost-effective strategy. Additionally, PIPAC C/D alone as a second-line therapy has the potential to reduce costs and improve clinical outcomes for patients with advanced gastric cancer with peritoneal metastasis.

Economic Analysis of the CADScor System for Ruling Out Coronary Artery Disease in England.

BACKGROUND: Coronary artery disease (CAD) is the most common type of heart and circulatory disease and is the leading cause of death worldwide. The current diagnostic pathway can lead to patient complications and is also extremely costly. A new medical device, the CADScor System (Acarix AB), was developed for the acoustic detection of CAD before patients undergo invasive diagnostic procedures. OBJECTIVES: Our objective was to assess the cost utility of the CADScor System for the diagnosis of CAD at an early stage in the diagnostic testing pathway in England. METHODS: A two-part economic model, consisting of a decision tree and Markov model, was developed to consider the cost utility (cost per quality-adjusted life-year [QALY] gained) of introducing the CADScor System for the diagnosis of CAD. The decision tree component explored the short-term costs and diagnostic outcomes associated with introduction of the test compared with the existing testing pathway. A Markov model was developed to explore the longer-term health and economic implications of the condition and original diagnosis, with costs and health effects estimated over different time horizons. Parameter uncertainty was explored in deterministic and probabilistic sensitivity analyses. RESULTS: Base-case results indicated that the CADScor System would result in cost savings (- £131 per patient) and a marginal increase in QALYs (0.00001) over a 1-year time horizon. Probabilistic results indicated that the intervention had a > 99% probability of being cost effective at a willingness-to-pay threshold of £20,000 per QALY gained and 100% probability of being cost saving. Results from the deterministic sensitivity analyses indicated that variations in parameters related to the accuracy and cost of the CADScor System, and the prevalence of CAD, had the greatest impact on the overall results. The overall cost saving was estimated to be over £12.3 million per 100,000 eligible patient population. CONCLUSIONS: The CADScor System is a potentially cost-saving test for the diagnosis of CAD. When initiated before the use of non-invasive cardiac imaging tests such as computed tomography coronary angiography, the test reduced costs to the healthcare service over various time horizons.

Continuous Monitoring of Respiratory Rate with Wearable Sensor in Patients Admitted to Hospital with Pneumonia Compared with Intermittent Nurse-Led Monitoring in the United Kingdom: A Cost-Utility Analysis.

BACKGROUND: Respiratory rate (RR) is one of the most important physiologic measures for predicting patients' deterioration of clinical condition and final prognosis. In several studies, RR has been the most important predictor of patients' prognoses. OBJECTIVES: The objective of this study was to conduct a cost-utility analysis to estimate the cost and effectiveness of automatic respiratory rate monitoring (ARRM) with a non-invasive sensor (RespiraSense™) plus intermittent nurse-led RR monitoring (ARRM strategy) compared with intermittent nurse-led RR monitoring (IM strategy) in patients admitted to hospital in the UK with pneumonia. METHODS: A decision analytic model was developed based on a hypothetical cohort of patients who were admitted to hospital with pneumonia. After admission, the patients could be monitored with either ARRM or IM strategies. The outcomes of interest included total costs and total effectiveness of each strategy, including length of stay (LoS) in hospital, LoS in intensive care unit, quality-adjusted life-years (QALYs), deaths, and incremental cost per QALY gained. An incremental cost of £20,000 or less per QALY gained was considered cost effective. A lifetime time horizon (38 years) was used to capture the long-term benefits. Probabilistic and deterministic sensitivity analyses were performed. RESULTS: Total costs of patient care in ARRM and IM strategies were £1986.9 million and £2079.4 million, respectively. Total incremental QALYs lived were 3548 higher in the intervention arm (ARRM), meaning that the ARRM strategy was dominant (i.e., less costly [£92.6 million less] and more effective). The results were stable in probabilistic and most of the deterministic sensitivity analyses. Results from threshold analysis indicated that a minimum of 7 and 10% improvement in percentage of early detection of respiratory compromise is required for ARRM to become cost effective and cost saving, respectively. CONCLUSIONS: Our results indicate that ARRM using RespiraSense, in addition to intermittent nurse-led monitoring of RR, in patients admitted to the hospital with pneumonia could be a cost-saving and cost-effective intervention if the minimum clinical thresholds are met.

Cost-utility analysis of normothermic liver perfusion with the OrganOx metra compared to static cold storage in the United Kingdom.

BACKGROUND: Rising numbers of patients on the liver transplant waiting list has led to the utilization of organs from higher-risk donors that are more likely to be discarded and are prone to post-transplant complications. Storage and transportation of these livers at low temperatures can cause damage. OrganOx metra is a portable device intended to preserve and maintain the donated liver in normothermic conditions for up to 24 h prior to transplantation. OBJECTIVE: To evaluate the cost-utility of normothermic machine perfusion with OrganOx metra in liver transplantation compared to the current practice of static cold storage (SCS). METHODS: A de novo decision analytic model (a decision tree along with a Markov model), based on current treatment pathways, was developed to estimate the costs and outcomes. Results from a randomized clinical trial and national standard sources were used to inform the model. Costs were estimated from the National Health Service and Personal Social Services perspective. Deterministic and probabilistic sensitivity analyses (PSA) were conducted to explore uncertainty surrounding input parameters. RESULTS: Over a lifetime time horizon, liver transplantation with OrganOx metra was more costly and more effective than the current practice of static cold storage. The total costs per patient were £37,370 vs £46,711, and the total effectiveness per patient was 9.09 QALYs vs 10.27 QALYs for SCS and OrganOx metra groups, respectively. The estimated ICER was £7,876 per each QALY gained. Results from the PSA showed that use of OrganOx metra has 99% probability of being cost-effective at a £20,000 willingness-to-pay threshold. OrganOx metra led to the utilization of 54 additional livers with patients experiencing lower rates of early allograft dysfunction and adverse events. CONCLUSIONS: Use of OrganOx metra for the perfusion and transportation of livers prior to transplantation is a cost-effective strategy. KEY POINTS FOR DECISION MAKERS Introduction of OrganOx metra into NHS could increase the utilisation of donated livers with patients experiencing lower rates of early allograft dysfunction and adverse events, compared with current practice. Results of the economic analysis indicate that the OrganOx metra is highly likely to be cost-effective and result in improved patient outcomes.

Economic analysis of Electrical Muscle Stimulator with Multipath technology for the treatment of stress urinary incontinence: a UK-based cost-utility analysis.

Background: Stress urinary incontinence (SUI) is a debilitating and highly prevalent condition in the UK. The condition is associated with a significant economic burden for affected patients and society. Current treatment options for SUI include minimally invasive therapies, medication and surgical intervention for the most serious cases. Electrical Muscle Stimulator with Multipath technology is a recently developed device for the treatment of SUI that relies on neuromuscular external electrical stimulation (NEES) technology. The clinical efficacy of the device has been proven in previous studies, but existing evidence surrounding its economic viability is limited.Objectives: To assess the cost-utility of the Electrical Muscle Stimulator with Multipath technology Therapy device for the treatment of SUI amongst women in a UK setting.Methods: An economic model was developed to consider the cost-utility (cost per quality-adjusted life-year [QALY] gained) of Electrical Muscle Stimulator with Multipath technology compared with current practice. A Markov model was developed, with costs and health effects estimated over the lifetime of the patient in the base-case analysis. The model was developed to reflect the treatment pathways typically followed by patients with SUI in the UK. Parameter uncertainty was explored in deterministic and probabilistic sensitivity analyses.Results: Base-case results indicate that Electrical Muscle Stimulator with Multipath technology results in cost savings and QALY gains over the patient's lifetime. In the "cure" analysis, the intervention is £250 less costly and leads to a 0.03 QALY gain per patient, while in the "improvement analysis", the intervention is £327 less costly and leads to a 0.13 QALY gain per patient. Results from the probabilistic sensitivity analyses show that the likelihood of Electrical Muscle Stimulator with Multipath technology being cost-effective is greater than 74% across all willingness-to-pay thresholds in the two analyses presented.Conclusions: Electrical Muscle Stimulator with Multipath technology is a potentially cost-effective treatment option for patients with SUI who have failed first-line treatment. It could reduce costs to the health care service and improve quality-of-life for selected patients over their lifetime.

Cost utility analysis of continuous and intermittent versus intermittent vital signs monitoring in patients admitted to surgical wards.

Background: Complications after surgical procedures are common and can lead to a prolonged hospital stay, increased rates of postoperative hospital readmission, and increased mortality. Monitoring vital signs is an effective way to identify patients who are experiencing a deterioration in health. SensiumVitals is wireless system that includes a lightweight, digital patch that monitors vital signs at two minute intervals, and has shown promise in the early identification of patients at high risk of deterioration.Objective: To evaluate the cost-utility of continuous monitoring of vital signs with SensiumVitals in addition to intermittent monitoring compared to the usual care of patients admitted to surgical wards.Methods: A de novo decision analytic model, based on current treatment pathways, was developed to estimate the costs and outcomes. Results from randomised clinical trials and national standard sources were used to inform the model. Costs were estimated from the NHS and PSS perspective. Deterministic and probabilistic sensitivity analyses (PSA) were conducted to explore uncertainty surrounding input parameters.Results: Over a 30-day time horizon, intermittent monitoring in addition to continuous monitoring of vital signs with SensiumVitals was less costly than intermittent vital signs monitoring alone. The total cost per patient was £6,329 versus £5,863 for the comparator and intervention groups respectively and the total effectiveness per patient was 0.057 QALYs in each group. Results from the PSA showed that use of SensiumVitals in addition to intermittent monitoring has 73% probability of being cost-effective at a £20,000 willingness-to-pay threshold and 73% probability of being cost-saving compared to the comparator. Cost savings were driven by reduced costs of hospital readmissions and length of stays in hospital.Conclusions: Use of SensiumVitals as a postoperative intervention for patients on surgical wards is a cost-saving and cost-effective strategy, yielding improvements in recovery with decreased health resource use.Key Points for Decision MakersSensiumVitals has the potential to reduce the length of postoperative hospital stay, readmission rates, and associated costs in postoperative patients.In this study, SensiumVitals has been found to be a cost-saving (dominant) and cost-effective (dominant) intervention for monitoring the vital signs of surgical patients postoperatively.

DyeVert™ PLUS EZ System for Preventing Contrast-Induced Acute Kidney Injury in Patients Undergoing Diagnostic Coronary Angiography and/or Percutaneous Coronary Intervention: A UK-Based Cost-Utility Analysis.

BACKGROUND: Contrast-induced acute kidney injury (CI-AKI) is a complication commonly associated with invasive angiographic procedures and is considered the leading cause of hospital-acquired acute kidney injury. CI-AKI can lead to a prolonged hospital stay, with a substantial economic impact, and increased mortality. The DyeVert™ PLUS EZ system (FDA approved and CE marked) is a device that has been developed to divert a portion of the theoretical injected contrast media volume (CMV), reducing the overall volume of contrast media injected and aortic reflux, and potentially improving long-term health outcomes. OBJECTIVES: To assess the long-term costs and health outcomes associated with the introduction of the DyeVert™ PLUS EZ system into the UK health care service for the prevention of CI-AKI in a cohort of patients with chronic kidney disease (CKD) stage 3-4 undergoing diagnostic coronary angiography (DAG) and/or percutaneous coronary intervention (PCI), and to compare these costs and outcomes with those of the current practice. METHODS: A de novo economic model was developed based on the current pathway of managing patients undergoing DAG and/or PCI and on evidence related to the clinical effectiveness of DyeVert™ in terms of its impact on relevant clinical outcomes and health service resource use. Clinical data used to populate the model were derived from the literature or were based on assumptions informed by expert clinical input. Costs included in the model were from the NHS and personal social services perspective and obtained from the literature and UK-based routine sources. Probabilistic distributions were assigned to the majority of model parameters so that a probabilistic analysis could be undertaken, while deterministic sensitivity analyses were also carried out to explore the impact of key parameter variation on the model results. RESULTS: Base-case results indicate that the intervention leads to cost savings (- £435) and improved effectiveness (+ 0.028 QALYs) over the patient's lifetime compared with current practice. Output from the probabilistic analysis points to a high likelihood of the intervention being cost-effective across presented willingness-to-pay (WTP) thresholds. The overall long-term cost saving for the NHS associated with the introduction of the DyeVert™ PLUS EZ system is over £19.7 million for each annual cohort of patients. The cost savings are mainly driven by a lower risk of subsequent diseases and their associated costs. CONCLUSIONS: The introduction of the DyeVert™ PLUS EZ system has the potential to reduce costs for the health care service and yield improved clinical outcomes for patients with CKD stage 3-4 undergoing angiographic procedures.

Laparoscopic colposuspension for urinary incontinence in women.

BACKGROUND: Laparoscopic colposuspension was one of the first minimal access operations for treating stress urinary incontinence in women, with the presumed advantages of shorter hospital stays and quicker return to normal activities. This Cochrane Review was last updated in 2010. OBJECTIVES: To assess the effects of laparoscopic colposuspension for urinary incontinence in women; and summarise the principal findings of relevant economic evaluations of these interventions. SEARCH METHODS: We searched the Cochrane Incontinence Specialised Register (22 May 2019), which contains trials identified from CENTRAL, MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings. SELECTION CRITERIA: Randomised controlled trials of women with urinary incontinence that included laparoscopic surgery in at least one arm. DATA COLLECTION AND ANALYSIS: We independently extracted data from eligible trials, assessed risk of bias and implemented GRADE. MAIN RESULTS: We included 26 trials involving 2271 women. Thirteen trials (1304 women) compared laparoscopic colposuspension to open colposuspension and nine trials (412 women) to midurethral sling procedures. One trial (161 women) compared laparoscopic colposuspension with one suture to laparoscopic colposuspension with two sutures; and three trials (261 women) compared laparoscopic colposuspension with sutures to laparoscopic colposuspension with mesh and staples. The majority of trials did not follow up participants beyond 18 months. Overall, there was unclear risk of selection, performance and detection bias and generally low risk of attrition and reporting bias. There is little difference between laparoscopic colposuspension using sutures and open colposuspension for subjective cure within 18 months (risk ratio (RR) 1.04, 95% confidence interval (CI) 0.99 to 1.08; 6 trials, 755 women; high-quality evidence). We are uncertain whether laparoscopic colposuspension using mesh and staples is better or worse than open colposuspension for subjective cure within 18 months (RR 0.75, 95% CI 0.61 to 0.93; 3 trials, 362 women; very low-quality evidence) or whether there is a greater risk of repeat continence surgery with laparoscopic colposuspension. Laparoscopic colposuspension may have a lower risk of perioperative complications (RR 0.67, 95% CI 0.47 to 0.94; 11 trials, 1369 women; low-quality evidence). There may be similar or higher rates of bladder perforations with laparoscopic colposuspension (RR 1.72, 95% CI 0.90 to 3.29; 10 trials, 1311 women; moderate-quality evidence). Rates for de novo detrusor overactivity (RR 1.29, 95% CI 0.72 to 2.30; 5 trials, 472 women) and voiding dysfunction (RR 0.81, 95% CI 0.50 to 1.31; 5 trials, 507 women) may be similar but we are uncertain due to the wide confidence interval. Five studies reported on quality of life but we could not synthesise the data. There may be little difference between laparoscopic colposuspension using sutures and tension-free vaginal tape (TVT) for subjective cure within 18 months (RR 1.01, 95% CI 0.88 to 1.16; 4 trials, 256 women; low-quality evidence) or between laparoscopic colposuspension using mesh and staples and TVT (RR 0.71, 95% CI 0.55 to 0.91; 1 trial, 121 women; low-quality evidence). For laparoscopic colposuspension compared with midurethral slings, there may be lower rates of repeat continence surgery (RR 0.40, 95% CI 0.04 to 3.62; 1 trial, 70 women; low-quality evidence) and similar risk of perioperative complications (RR 0.99, 95% CI 0.60 to 1.64; 7 trials, 514 women; low-quality evidence) but we are uncertain due to the wide confidence intervals. There may be little difference in terms of de novo detrusor overactivity (RR 0.80, 95% CI 0.34 to 1.88; 4 trials, 326 women; low-quality evidence); and probably little difference in terms of voiding dysfunction (RR 1.06, 95% CI 0.47 to 2.41; 5 trials, 412 women; moderate-quality evidence) although we are uncertain due to the wide confidence interval. Five studies reported on quality of life but we could not synthesise the data. No studies reported on bladder perforations. Low-quality evidence indicates that there may be higher subjective cure rates within 18 months with two sutures compared to one suture (RR 1.37, 95% CI 1.14 to 1.64; 1 trial, 158 women). Comparing one suture and two sutures, one suture may have lower rates of repeat continence surgery (RR 0.35, 95% CI 0.01 to 8.37; 1 trial, 157 women) and similar risk of perioperative complications (RR 0.88, 95% CI 0.45 to 1.70) but we are uncertain due to the wide 95% CIs. There may be higher rates of voiding dysfunction with one suture compared to two sutures (RR 2.82; 95% CI 0.30 to 26.54; 1 trial, 158 women; low-quality evidence), but we are uncertain due to the wide confidence interval. This trial did not report bladder perforations, de novo detrusor overactivity or quality of life. We are uncertain whether laparoscopic colposuspension with sutures is better or worse for subjective cure within 18 months compared to mesh and staples (RR 1.24, 95% CI 0.96 to 1.59; 2 trials, 180 women; very low-quality evidence) or in terms of repeat continence surgery (RR 0.97, 95% CI 0.06 to 14.91; 1 trial, 69 women; very low-quality evidence). Laparoscopic colposuspension with sutures may increase the number of perioperative complications compared to mesh and staples (RR 1.94, 95% CI 1.09 to 3.48; 3 trials, 260 women; low-quality evidence) but rates of de novo detrusor overactivity may be similar (RR 0.72, 95% CI 0.17 to 3.06; 2 trials, 122 women; low-quality evidence), however, we are uncertain due to the wide confidence interval. None of the studies reported bladder perforations, voiding dysfunction or quality of life. AUTHORS' CONCLUSIONS: The data indicate that, in terms of subjective cure of incontinence within 18 months, there is probably little difference between laparoscopic colposuspension and open colposuspension, or between laparoscopic colposuspension and midurethral sling procedures. Much of the evidence is low quality, meaning that a considerable degree of uncertainty remains about laparoscopic colposuspension. Future trials should recruit adequate numbers, conduct long-term follow-up and measure clinically important outcomes. A brief economic commentary identified three studies. We have not quality-assessed them and they should be interpreted in light of the findings on clinical effectiveness.

Estimation and Prediction of Avoidable Health Care Costs of Cardiovascular Diseases and Type 2 Diabetes Through Adequate Dairy Food Consumption: A Systematic Review and Micro Simulation Modeling Study.

BACKGROUND: Recent evidence from prospective cohort studies show a relationship between consumption of dairy foods and cardiovascular diseases (CVDs) and type 2 diabetes mellitus (T2DM). This association highlights the importance of dairy foods consumption in prevention of these diseases and also reduction of associated healthcare costs. The aim of this study was to estimate avoidable healthcare costs of CVD and T2D through adequate dairy foods consumption in Iran. METHODS: This was a multistage modelling study. We conducted a systematic literature review in PubMed and EMBASE to identify any association between incidence of CVD and T2DM and dairy foods intake, and also associated relative risks. We obtained age- and sex-specific dairy foods consumption level and healthcare expenditures from national surveys and studies. Patient level simulation Markov models were constructed to predict the disease incidence, patient population size and associated healthcare costs for current and optimal dairy foods consumption at different time horizons (1, 5, 10 and 20 years). All parameters including costs and transition probabilities were defined as statistical distributions in the models, and all analyses were conducted by accounting for first and second order uncertainty. RESULTS: The systematic review results indicated that dairy foods consumption was inversely associated with incidence of T2DM, coronary heart disease (CHD) and stroke. We estimated that the introduction of a diet containing 3 servings of dairy foods per day may produce a $0.43 saving in annual per capita healthcare costs in Iran in the first year due to saving in cost of CVD and T2DM treatment. The estimated savings in per capita healthcare costs were $8.42, $39.97 and $190.25 in 5, 10 and 20-years' time, respectively. Corresponding total aggregated avoidable costs for the entire Iranian population within the study time horizons were $33.83, $661.31, $3,138.21 and $14,934.63 million, respectively. CONCLUSION: Our analysis demonstrated that increasing dairy foods consumption to recommended levels would be associated with reductions in healthcare costs. Further randomized trial studies are required to investigate the effect of dairy foods intake on cost of CVD and T2DM in the population.

Anterior vaginal repair for urinary incontinence in women.

BACKGROUND: Anterior vaginal repair (anterior colporrhaphy) is an operation traditionally used for moderate or severe stress urinary incontinence (SUI) in women. About a third of adult women experience urinary incontinence. SUI imposes significant health and economic burden to the society and the women affected. OBJECTIVES: To determine the effects of anterior vaginal repair (anterior colporrhaphy) on urinary incontinence in comparison with other management options. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Trials Register (searched 1 September 2009) and the reference lists of relevant articles. SELECTION CRITERIA: Randomised or quasi-randomised trials that included anterior vaginal repair for the treatment of urinary incontinence. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed trial quality. Three trial investigators were contacted for additional information. MAIN RESULTS: Ten trials were identified which included 385 women having an anterior vaginal repair and 627 who received comparison interventions.A single small trial provided insufficient evidence to assess anterior vaginal repair in comparison with physical therapy. The performance of anterior repair in comparison with bladder neck needle suspension appeared similar (risk ratio (RR) for failure after one year 1.16, 95% confidence interval (CI) 0.86 to 1.56), but clinically important differences could not be confidently ruled out. No trials compared anterior repair with suburethral sling operations or laparoscopic colposuspensions, or compared alternative vaginal operations.Anterior vaginal repair was less effective than open abdominal retropubic suspension based on patient-reported cure rates in eight trials both in the medium term (failure rate within one to five years after anterior repair 97/259 (38%) versus 57/327 (17%); RR 2.29, 95% confidence Interval (CI) 1.70 to 3.08) and in the long term (after five years, (49/128 (38%) versus 31/145 (21%); RR 2.02, 95% CI 1.36 to 3.01). There was evidence from three of these trials that this was reflected in a need for more repeat operations for incontinence (25/107 (23%) versus 4/164 (2%); RR 8.87, 95% CI 3.28 to 23.94). These findings held, irrespective of the co-existence of prolapse (pelvic relaxation). Although fewer women had a prolapse after anterior repair (RR 0.24, 95% CI 0.12 to 0.47), later prolapse operation appeared to be equally common after vaginal (3%) or abdominal (4%) operation.In respect of the type of open abdominal retropubic suspension, most data related to comparisons of anterior vaginal repair with Burch colposuspension. The few data describing comparison of anterior repair with the Marshall-Marchetti-Krantz procedure were consistent with those for Burch colposuspension. AUTHORS' CONCLUSIONS: There were not enough data to allow comparison of anterior vaginal repair with physical therapy or needle suspension for primary urinary stress incontinence in women. Open abdominal retropubic suspension appeared to be better than anterior vaginal repair judged on subjective cure rates in eight trials, even in women who had prolapse in addition to stress incontinence (six trials). The need for repeat incontinence surgery was also less after the abdominal operation. However, there was not enough information about postoperative complications and morbidity.A Brief Economic Commentary (BEC) identified one study suggesting that vaginoplasty may be more cost-effective compared with tension-free vaginal tape (TVT-O).

Open retropubic colposuspension for urinary incontinence in women.

BACKGROUND: Urinary incontinence is a common and potentially debilitating problem. Stress urinary, incontinence as the most common type of incontinence, imposes significant health and economic burdens on society and the women affected. Open retropubic colposuspension is a surgical treatment which involves lifting the tissues near the bladder neck and proximal urethra in the area behind the anterior pubic bones to correct deficient urethral closure to correct stress urinary incontinence. OBJECTIVES: The review aimed to determine the effects of open retropubic colposuspension for the treatment of urinary incontinence in women. A secondary aim was to assess the safety of open retropubic colposuspension in terms of adverse events caused by the procedure. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE in process, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 5 May 2015), and the reference lists of relevant articles. We contacted investigators to locate extra studies. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials in women with symptoms or urodynamic diagnoses of stress or mixed urinary incontinence that included open retropubic colposuspension surgery in at least one trial group. DATA COLLECTION AND ANALYSIS: Studies were evaluated for methodological quality or susceptibility to bias and appropriateness for inclusion and data extracted by two of the review authors. Trial data were analysed by intervention. Where appropriate, a summary statistic was calculated. MAIN RESULTS: This review included 55 trials involving a total of 5417 women.Overall cure rates were 68.9% to 88.0% for open retropubic colposuspension. Two small studies suggested lower incontinence rates after open retropubic colposuspension compared with conservative treatment. Similarly, one trial suggested lower incontinence rates after open retropubic colposuspension compared to anticholinergic treatment. Evidence from six trials showed a lower incontinence rate after open retropubic colposuspension than after anterior colporrhaphy. Such benefit was maintained over time (risk ratio (RR) for incontinence 0.46; 95% CI 0.30 to 0.72 before the first year, RR 0.37; 95% CI 0.27 to 0.51 at one to five years, RR 0.49; 95% CI 0.32 to 0.75 in periods beyond five years).Evidence from 22 trials in comparison with suburethral slings (traditional slings or trans-vaginal tape or transobturator tape) found no overall significant difference in incontinence rates in all time periods evaluated (as assessed subjectively RR 0.90; 95% CI 0.69 to 1.18, within one year of treatment, RR 1.18; 95%CI 1.01 to 1.39 between one and five years, RR 1.11; 95% CI 0.97 to 1.27 at five years and more, and as assessed objectively RR 1.24; 95% CI 0.93 to 1.67 within one year of treatment, RR 1.12; 95% CI 0.82 to 1.54 for one to five years follow up, RR 0.70; 95% CI 0.30 to 1.64 at more than five years). However, subgroup analysis of studies comparing traditional slings and open colposuspension showed better effectiveness with traditional slings in the medium and long term (RR 1.35; 95% CI 1.11 to 1.64 from one to five years follow up, RR 1.19; 95% CI 1.03 to 1.37).In comparison with needle suspension, there was a lower incontinence rate after colposuspension in the first year after surgery (RR 0.66; 95% CI 0.42 to 1.03), after the first year (RR 0.56; 95% CI 0.39 to 0.81), and beyond five years (RR 0.32; 95% CI 15 to 0.71).Patient-reported incontinence rates at short, medium and long-term follow-up showed no significant differences between open and laparoscopic retropubic colposuspension, but with wide confidence intervals. In two trials incontinence was less common after the Burch (RR 0.38; 95% CI 0.18 to 0.76) than after the Marshall Marchetti Krantz procedure at one to five year follow-up. There were few data at any other follow-up times.In general, the evidence available does not show a higher morbidity or complication rate with open retropubic colposuspension compared to the other open surgical techniques, although pelvic organ prolapse is more common than after anterior colporrhaphy and sling procedures. Voiding problems are also more common after sling procedures compared to open colposuspension. AUTHORS' CONCLUSIONS: Open retropubic colposuspension is an effective treatment modality for stress urinary incontinence especially in the long term. Within the first year of treatment, the overall continence rate is approximately 85% to 90%. After five years, approximately 70% of women can expect to be dry. Newer minimal access sling procedures look promising in comparison with open colposuspension but their long-term performance is limited and closer monitoring of their adverse event profile must be carried out. Open colposuspension is associated with a higher risk of pelvic organ prolapse compared to sling operations and anterior colporrhaphy, but with a lower risk of voiding dysfunction compared to traditional sling surgery. Laparoscopic colposuspension should allow speedier recovery but its relative safety and long-term effectiveness is not yet known. A Brief Economic Commentary (BEC) identified five studies suggesting that tension-free vaginal tape (TVT) and laparoscopic colposuspension may be more cost-effective compared with open retropubic colposuspension.

Bladder neck needle suspension for urinary incontinence in women.

BACKGROUND: Bladder neck needle suspension is an operation traditionally used for moderate or severe stress urinary incontinence in women. About a third of adult women experience some urinary incontinence, and about a third of these have moderate or severe symptoms. Stress urinary incontinence (SUI) imposes significant health and economic burdens on society and the women affected. OBJECTIVES: To determine the effects of needle suspension on stress or mixed urinary incontinence in comparison with other management options. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE in process, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 12 November 2014), and the reference lists of relevant articles. SELECTION CRITERIA: Randomised or quasi-randomised trials that included needle suspension for the treatment of urinary incontinence. DATA COLLECTION AND ANALYSIS: At least two authors assessed trials and extracted data independently. Two trial investigators provided additional information. MAIN RESULTS: We identified 10 trials, which included 375 women having six different types of needle suspension procedures and 489 who received comparison interventions. Needle suspensions were more likely to fail than open abdominal retropubic suspension. There was a higher subjective failure rate after the first year (91/313 (29%) failed versus 47/297 (16%) failed after open abdominal retropubic suspension). The risk ratio (RR) was 2.00 (95% confidence interval (CI) 1.47 to 2.72), although the difference in peri-operative complications was not significant (17/75 (23%) versus 12/77 (16%); RR 1.44, 95% CI 0.73 to 2.83). There were no significant differences for the other outcome measures. This effect was seen in both women with primary incontinence and women with recurrent incontinence after failed primary operations. Needle suspensions may be as effective as anterior vaginal repair (50/156 (32%) failed after needle suspension versus 64/181 (35%) after anterior repair; RR 0.86, 95% CI 0.64 to 1.16), but there was little information about morbidity. Data for comparison with suburethral slings were inconclusive because they came from a small and atypical population.No trials compared needle suspensions with conservative management, peri-urethral injections, or sham or laparoscopic surgery. AUTHORS' CONCLUSIONS: Bladder neck needle suspension surgery is probably not as good as open abdominal retropubic suspension for the treatment of primary and secondary urodynamic stress incontinence because the cure rates were lower in the trials reviewed. However, the reliability of the evidence was limited by poor quality and small trials. There was not enough information to comment on comparisons with suburethral sling operations. Although cure rates were similar after needle suspension compared with after anterior vaginal repair, the data were insufficient to be reliable and inadequate to compare morbidity. A Brief Economic Commentary (BEC) identified no cost-effectiveness studies comparing bladder neck needle suspension with other surgeries.

Laparoscopic colposuspension for urinary incontinence in women.

BACKGROUND: Stress urinary incontinence (SUI) imposes significant health and economic burden on society and the women affected. Laparoscopic colposuspension was one of the first minimal access operations for the treatment of women with SUI, with the presumed advantages of avoiding major incisions, shorter hospital stays and quicker return to normal activities. OBJECTIVES: To determine the effects of laparoscopic colposuspension for urinary incontinence in women. SEARCH METHODS: We searched the Cochrane Incontinence Group Trials Register (searched 2 July 2009), and sought additional trials from other sources and by contacting study authors for unpublished data and trials. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials in women with symptomatic or urodynamic diagnosis of stress or mixed incontinence that included laparoscopic surgery as the intervention in at least one arm of the studies. DATA COLLECTION AND ANALYSIS: The review authors evaluated trials for methodological quality and their appropriateness for inclusion in the review. Two review authors extracted data and another cross checked them. Where appropriate, we calculated a summary statistic. MAIN RESULTS: We identified 22 eligible trials. Ten involved the comparison of laparoscopic with open colposuspension. Whilst the women's subjective impression of cure seemed similar for both procedures, in the short- and medium-term follow-up, there was some evidence of poorer results of laparoscopic colposuspension on objective outcomes. The results showed trends towards fewer perioperative complications, less postoperative pain and shorter hospital stay for laparoscopic compared with open colposuspension, however, laparoscopic colposuspension was more costly.Eight studies compared laparoscopic colposuspension with newer 'self-fixing' vaginal slings. There were no significant differences in the reported short- and long-term subjective cure rates of the two procedures but objective cure rates at 18 months favoured slings. We observed no significant differences for postoperative voiding dysfunction and perioperative complications. Laparoscopic colposuspension had a significantly longer operation time and hospital stay. We found significantly higher subjective and objective one-year cure rates for women randomised to two paravaginal sutures compared with one suture in a single trial. Three studies compared sutures with mesh and staples for laparoscopic colposuspension and showed a trend towards favouring the use of sutures. AUTHORS' CONCLUSIONS: Currently available evidence suggests that laparoscopic colposuspension may be as good as open colposuspension at two years post surgery. However, the newer vaginal sling procedures appear to offer even greater benefits, better objective outcomes in the short term and similar subjective outcomes in the longer term. If laparoscopic colposuspension is performed, the use of two paravaginal sutures appears to be the most effective method. The place of laparoscopic colposuspension in clinical practice should become clearer when there are more data available describing long-term results. A brief economic commentary (BEC) identified three studies suggesting that tension-free vaginal tape (TVT) may be more cost-effective compared with laparoscopic colposuspension but laparoscopic colposuspension may be slightly more cost-effective when compared with open colposuspension after 24 months follow-up.

Comparison of health-related quality of life after percutaneous coronary intervention and coronary artery bypass surgery.

BACKGROUND: Health-related quality of life (HRQOL) evaluation is an important measure of the impact of the disease. As more people with coronary heart disease (CHD) live longer, doctors and researchers want to know how they manage in day to day life. It looked like adults with CHD had a decrease QOL. The aim of this study was to comparison of HRQOL of patients who underwent percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) and to assess its main determinants in the whole sample of coronary artery disease (CAD) patients. METHODS: The study was carried out to estimate HRQOL of 109 patients who underwent invasive coronary revascularization [PCI (n = 75) and CABG (n = 34)]. We applied HRQOL after 6 months and 2 years in both groups and scores were compared. The HRQOL data were obtained using MacNew Heart Disease questionnaire with dimensions emotional, physical and social that estimated. Data entry and analysis were performed by SPSS. RESULTS: A total MacNew scale in CABG and PCI group in 6 months after treatment were 45.32 ± 13.75 and 53.52 ± 15.63, respectively (P = 0.010). After 2 years HRQOL mean changed to 51.176 ± 14.80 and 49.55 ± 16.22, respectively, in CABG and PCI group (P = 0.428). Our results in within-group analysis showed total MacNew scale and its subscales were changed significantly after 2 years in CABG and PCI group's scores were detected. We found in the whole sample of CAD patients those who had a higher level of income and education and were not either overweight or obese experienced better HRQOL. CONCLUSION: Our results showed that patients who underwent PCI experienced significantly higher HRQOL in 6 months after revascularization but over 24 months follow-up no difference was observed between the two groups.

Projection of Diabetes Population Size and Associated Economic Burden through 2030 in Iran: Evidence from Micro-Simulation Markov Model and Bayesian Meta-Analysis.

BACKGROUND: The aim of this study was to estimate the economic burden of diabetes mellitus (DM) in Iran from 2009 to 2030. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.