Uterine artery embolisation or myomectomy for women with uterine fibroids wishing to avoid hysterectomy: a cost-utility analysis of the FEMME trial.

OBJECTIVES: To assess the cost-effectiveness of uterine artery embolisation (UAE) and myomectomy for women with symptomatic uterine fibroids wishing to avoid hysterectomy. DESIGN: Economic evaluation alongside the FEMME randomised controlled trial. SETTING: 29 UK hospitals. POPULATION: Premenopausal women who had symptomatic uterine fibroids amenable to UAE or myomectomy wishing to avoid hysterectomy. 254 women were randomised to UAE (127) and myomectomy (127). METHODS: A within-trial cost-utility analysis was conducted from the perspective of the UK NHS. MAIN OUTCOME MEASURES: Quality-adjusted life years (QALYs) measured using the EuroQoL EQ-5D-3L, combined with costs to estimate cost-effectiveness over 2 and 4 years of follow-up. RESULTS: Over a 2-year time horizon, UAE was associated with higher mean costs (difference £645; 95% CI -1381 to 2580) and lower QALYs (difference -0.09; 95% CI -0.11 to -0.04) when compared with myomectomy. Similar results were observed over the 4-year time horizon. Thus, UAE was dominated by myomectomy. Results of the sensitivity analyses were consistent with the base case results for both years. Over 2 years, UAE was associated with higher costs (difference £456; 95% CI -1823 to 3164) and lower QALYs (difference -0.06; 95% CI -0.11 to -0.02). CONCLUSIONS: Myomectomy is a cost-effective option for the treatment of uterine fibroids. The differences in costs and QALYs are small. Women should be fully informed and have the option to choose between the two procedures. TWEETABLE ABSTRACT: Fully informed women with uterine fibroids should have a choice between uterine artery embolisation or myomectomy.

Bariatric surgery is expensive but improves co-morbidity: 5-year assessment of patients with obesity and type 2 diabetes.

BACKGROUND: Bariatric surgery can be effective in weight reduction and diabetes remission in some patients, but is expensive. The costs of bariatric surgery in patients with obesity and type 2 diabetes mellitus (T2DM) were explored here. METHODS: Population-based retrospectively gathered data on patients with obesity and T2DM from the Hong Kong Hospital Authority (2006-2017) were evaluated. Direct medical costs from baseline up to 60 months were calculated based on the frequency of healthcare service utilization and dispensing of diabetes medication. Charlson Co-morbidity Index (CCI) scores and co-morbidity rates were measured to compare changes in co-morbidities between surgically treated and control groups over 5 years. One-to-five propensity score matching was applied. RESULTS: Overall, 401 eligible surgical patients were matched with 1894 non-surgical patients. Direct medical costs were much higher for surgical than non-surgical patients in the index year (€36 752 and €5788 respectively; P < 0·001) mainly owing to the bariatric procedure. The 5-year cumulative costs incurred by surgical patients were also higher (€54 135 versus €28 603; P < 0·001). Although patients who had bariatric surgery had more visits to outpatient and allied health professionals than those who did not across the 5-year period, surgical patients had shorter length of stay in hospitals than non-surgical patients in year 2-5. Surgical patients had significantly better CCI scores than controls after the baseline measurement (mean 3·82 versus 4·38 at 5 years; P = 0·016). Costs of glucose-lowering medications were similar between two groups, except that surgical patients had significantly lower costs of glucose-lowering medications in year 2 (€973 versus €1395; P = 0.012). CONCLUSION: Bariatric surgery in obese patients with T2DM is expensive, but leads to an improved co-morbidity profile, and reduced length of hospitalization.

The cost of prevalent and incident cardiovascular disease in people with type 2 diabetes in Scotland: data from the Scottish Care Information-Diabetes Collaboration.

AIM: To compare costs for three groups of people with type 2 diabetes, those at high risk of future cardiovascular disease, those without cardiovascular disease and those with established cardiovascular disease, and to also compare costs incurred by people with type 2 diabetes with an incident cardiovascular disease event with those who remain incident event-free over a 3-year period. METHODS: Data about people with type 2 diabetes in Scotland were obtained from the Scottish Care Information Diabetes registry. Data linkage was used to retrieve information on healthcare utilization, care home use and deaths. Productivity effects were estimated for those of non-pensionable age. We estimated costs over 12 months (prevalent cardiovascular disease) and 3 years from incident cardiovascular disease event. RESULTS: Mean annual cost per person with established cardiovascular disease was £6900, £3300 for a person at high risk of future cardiovascular disease, and £2500 for a person without cardiovascular disease and not at high risk. In year 1, the cost of an incident cardiovascular disease event was £16 700 compared with £2100 for people without an incident event. Over 2 years, the cumulative costs were £21 500 and £4200, and by year 3, £25 000 and £5900, respectively. CONCLUSIONS: Cardiovascular disease in people with type 2 diabetes places a significant financial burden on healthcare and the wider economy. Our results emphasize the financial consequences of cardiovascular disease prevention strategies.

Centrally inserted external catheters and totally implantable ports for the delivery of chemotherapy: a systematic review and meta-analysis of device-related complications.

PURPOSE: This systematic review and meta-analysis aimed to evaluate the risks of complications (infectious and non-infectious) including the need for device removal associated with centrally inserted external catheters compared with totally implantable ports in patients undergoing chemotherapy. METHODS: Relevant major electronic databases were searched from inception to December 2012. All randomized controlled trials (RCT) and observational studies that compared centrally inserted external catheters with totally implantable ports in patients undergoing chemotherapy were included in the systematic review. Meta-analysis was carried out to estimate the odds ratios of device-associated complications, including infection, non-infectious complications and device removal associated with external catheters relative to implantable ports. RESULTS: Overall, five RCTs and 25 observational studies were included in the study. The studies were heterogeneous, and included adults and children, with different types of cancer, undergoing chemotherapy. Based on the pooled estimates from included studies, external catheters were associated with approximately a three to four-fold increase in the risks of infections, non-infectious complications and device removal compared implantable ports. CONCLUSION: The findings of this study showed that totally implantable ports are superior to external catheters in terms of catheter-associated complications. However, a formal health technology assessment on the clinical and cost-effectiveness of the use of implantable ports compared with external catheters is needed to inform policy makers of the relative value of investing in totally implantable devices compared with external catheters.

Inpatient costs for people with type 1 and type 2 diabetes in Scotland: a study from the Scottish Diabetes Research Network Epidemiology Group.

AIMS/HYPOTHESIS: The rising prevalence of diabetes worldwide has increased interest in the cost of diabetes. Inpatient costs for all people with diabetes in Scotland were investigated. METHODS: The Scottish Care Information-Diabetes Collaboration (SCI-DC), a real-time clinical information system of almost all diagnosed cases of diabetes in Scotland, UK, was linked to data on all hospital admissions for people with diabetes. Inpatient stay costs were estimated using the 2007-2008 Scottish National Tariff. The probability of hospital admission and total annual cost of admissions were estimated in relation to age, sex, type of diabetes, history of vascular admission, HbA(1c), creatinine, body mass index and diabetes duration. RESULTS: In Scotland during 2005-2007, 24,750 people with type 1 and 195,433 people with type 2 diabetes were identified, accounting for approximately 4.3% of the total Scottish population (5.1 million). The estimated total annual cost of admissions for all people diagnosed with type 1 and type 2 diabetes was £26 million and £275 million, respectively, approximately 12% of the total Scottish inpatient expenditure (£2.4 billion). Sex, increasing age, serum creatinine, previous vascular history and HbA(1c) (the latter differentially in type 1 and type 2) were all associated with likelihood and total annual cost of admission. CONCLUSIONS/INTERPRETATION: Diabetes inpatient expenditure accounted for 12% of the total Scottish inpatient expenditure, whilst people with diabetes account for 4.3% of the population. Of the modifiable risk factors, HbA(1c) was the most important driver of cost in type 1 diabetes.

Randomised comparison of uterine artery embolisation (UAE) with surgical treatment in patients with symptomatic uterine fibroids (REST trial): 5-year results.

OBJECTIVE: To compare the long-term results of uterine artery embolisation (UAE) with surgery for women with symptomatic uterine fibroids. DESIGN: Pragmatic, open, multicentre, randomised trial. SETTING: Twenty-seven participating UK secondary care centres. SAMPLE: Women aged ≥18 years with symptomatic fibroids who were considered to justify surgical treatment. METHODS: In total, 157 women were randomised (in a 2:1 ratio): 106 to UAE and 51 to surgery (hysterectomy 42; myomectomy nine). MAIN OUTCOME MEASURES: Quality of life at 5 years, as assessed by the Short Form General Health Survey (SF-36). Secondary measures included complications, adverse events and the need for further intervention. RESULTS: There were no significant differences between groups in any of the eight components of the SF-36 scores at 5 years (minimum P = 0.45). Symptom score reduction and patient satisfaction with either treatment was very high, with no group difference. Rates of adverse events were similar in both groups (19% embolization and 25% surgery; P = 0.40). The 5-year intervention rate for treatment failure or complications was 32% (UAE arm) and 4% (surgery arm), respectively. The initial cost benefit of UAE over surgery at 12 months was substantially reduced because of subsequent interventions, with treatments being cost neutral at 5 years. CONCLUSIONS: We have found that UAE is a satisfactory alternative to surgery for fibroids. The less invasive nature of UAE needs to be balanced against the need for re-intervention in almost a third of patients. The choice should lie with the informed patient.

A multi-centre retrospective cohort study comparing the efficacy, safety and cost-effectiveness of hysterectomy and uterine artery embolisation for the treatment of symptomatic uterine fibroids. The HOPEFUL study.

OBJECTIVES: To examine and compare the medium-term results of hysterectomy and uterine artery embolisation (UAE) as a treatment for symptomatic uterine fibroids with regard to safety, efficacy, special issues in the UAE group, cost-effectiveness, and women's own perspectives on the treatments. DESIGN: Data were collected locally from patients' hospital records and also from patients themselves by postal questionnaire. Questionnaire data included free-text comments and this qualitative material was analysed using constant comparison. A two-stage probabilistic decision model was designed to estimate UK NHS costs and health outcomes in terms of quality-adjusted life-years (QALYs). SETTING: Eighteen NHS hospital trusts, 17 in England and one in Scotland. PARTICIPANTS: Eligible women (972 UAE, 762 hysterectomies) who had received treatment specifically for symptomatic fibroids were identified. INTERVENTIONS: The UAE patients were treated by experienced interventional radiologists and all received their index UAE prior to the end of 2002, ensuring a minimum 2-year follow-up. The average length of follow-up was 8.6 years for the hysterectomy cohort and 4.6 years for the UAE cohort. MAIN OUTCOME MEASURES: Primary outcome measures were complication rates to assess the comparative safety of the two interventions. Secondary outcome measures related to treatment efficacy including resolution of symptoms and patient-reported satisfaction with treatment. Further efficacy outcome measures obtained in the UAE group included fibroid/uterine size shrinkage and further treatments required for unresolved fibroid symptoms. Data were also gathered on pregnancies post-UAE. RESULTS: Data were available for 1108 women (649 UAE and 459 hysterectomy). Fewer complications were experienced by women in the UAE cohort compared to the hysterectomy cohort: hysterectomy n = 120 (26.1%), UAE n = 114 (17.6%), adjusted odds ratio 0.48 [95% confidence interval (CI) 0.26 to 0.89]. When only the severe/major complications were considered, this odds ratio was reduced to 0.25 (95% CI 0.13 to 0.48). Expected general side-effects of UAE occurred in 32.7% of the UAE cohort, of which 8.9% also experienced complications. Obesity and medical co-morbidity predisposed women to complications, whereas prophylactic antibiotics appeared to protect against both complications and the expected side-effects of UAE. More women in the hysterectomy cohort reported relief from fibroid symptoms (89% versus 80% UAE, p less than 0.0001) and feeling better (81% versus 74% UAE, p less than 0.0001), but only 70% (compared with 86% UAE, p = 0.007) would recommend their treatment to a friend. In the UAE cohort, 18.3% of the women went on to receive one or more further fibroid treatments including hysterectomy (11.2%). After adjusting for differential time of follow-up, the UAE women had up to a 23% (95% CI 19 to 27%) likelihood of requiring further treatment. The free-text data indicated that many women, in both cohorts, felt that their treatment had been a complete success. In the UAE cohort there were several areas where expectations were apparently high and outcome had not fulfilled their expectations. Disappointment was expressed mainly about continuation or return of symptoms or failure to become pregnant. Many continued to have remaining questions about their treatment. The economic analysis indicated that UAE is less expensive than hysterectomy even after further treatments for unresolved or recurrent symptoms are taken into account, with little difference in QALYs between the two treatments. Younger women are exposed to the risk of recurrent fibroids and subsequent additional procedures over a longer period and consequently UAE may no longer be cost-effective. CONCLUSIONS: The study results suggest that both UAE and hysterectomy are safe. No unexpected problems were detected following UAE after a long follow-up period (average 5 years). Complications are less common for UAE than hysterectomy. The cost-effectiveness analysis favours embolisation even after taking account of complications, expected side-effects associated with the procedure and subsequent re-treatments for women with a preference for uterus preservation. It is important to improve the management of expectations following UAE, particularly regarding fertility. The data suggested that fertility and miscarriage rate are consistent with those of age-matched women with fibroids. UAE is an effective treatment for some women with fibroids and our trial supports the National Institute for Health and Clinical Excellence guidance that it should be made available as one of the options for treatment, with a possible reduction in the need for hysterectomy as the first-line treatment. Further research is needed into which women will be treated most successfully by UAE, the best method of achieving effective embolisation, advice for women who desire future fertility, the role of prophylactic antibiotics in UAE, and the effects of HRT use after UAE on recurrence of fibroid symptoms.

Uterine artery embolisation or hysterectomy for the treatment of symptomatic uterine fibroids: a cost-utility analysis of the HOPEFUL study.

OBJECTIVES: To evaluate the relative cost-effectiveness of uterine artery embolisation (UAE) and hysterectomy in women with symptomatic uterine fibroids from the perspective of the UK NHS. DESIGN: Cost-utility analysis. SETTING: Eighteen UK NHS hospital trusts. POPULATION OR SAMPLE Women who underwent UAE (n= 649; average follow up of 8.6 years) or hysterectomy (n= 459; average follow up of 4.6 years) for the treatments of symptomatic fibroids. METHODS: A probabilistic decision model was carried out based on data from a large comparative cohort and the literature. The two interventions were evaluated over the time horizon from the initial procedure to menopause. Extensive sensitivity analysis was carried out to test model assumptions and parameter uncertainties. MAIN OUTCOME MEASURES: Costs of procedures and complications and quality of life expressed as quality-adjusted life years (QALYs). RESULTS: Overall, UAE was associated with lower mean cost (2536 pounds sterling versus 3282 pounds sterling) and a small reduction in quality of life (8.203 versus 8.241 QALYs) when compared with hysterectomy. However, when the quality of life associated with the conservation of the uterus was incorporated in the model, UAE was shown to be the dominant strategy--lower costs and greater QALYs. CONCLUSIONS: UAE is a less expensive option to the health service compared with hysterectomy, even when the costs of repeat procedures and associated complications are factored in. The quality of life implications in the short term are also predicted to favour UAE; however, this advantage may be eroded over time as women undergo additional procedures to deal with recurrent fibroids. Given the hysterectomy is the current standard treatment for symptomatic fibroids, offering women UAE as an alternative treatment for fibroids is likely to be highly cost-effective for those women who prefer uterus-conserving treatment.

Screening for thrombophilia in high-risk situations: systematic review and cost-effectiveness analysis. The Thrombosis: Risk and Economic Assessment of Thrombophilia Screening (TREATS) study.

OBJECTIVES: To assess the risk of clinical complications associated with thrombophilia in three high-risk patient groups: women using oral oestrogen preparations, women during pregnancy and patients undergoing major orthopaedic surgery. To assess the effectiveness of prophylactic treatments in preventing venous thromboembolism (VTE) and adverse pregnancy outcomes in women with thrombophilia during pregnancy and VTE in patients with thrombophilia, undergoing major orthopaedic surgery. To evaluate the relative cost-effectiveness of universal and selective VTE history-based screening for thrombophilia compared with no screening in the three high-risk patient groups. DATA SOURCES: Electronic databases including MEDLINE, EMBASE, and four other major databases were searched up to June 2003. REVIEW METHODS: In order to assess the risk of clinical complications associated with thrombophilia, a systematic review of the literature on VTE and thrombophilia in women using oral oestrogen preparations and patients undergoing major orthopaedic surgery; and studies of VTE and adverse obstetric complications in women with thrombophilia during pregnancy was carried out. Meta-analysis was used to calculate pooled odds ratios (ORs) associated with individual clinical outcomes, stratified by thrombophilia type and were calculated for each patient group. To assess the effectiveness of prophylaxis, a systematic review was carried out on the use of prophylaxis in the prevention of VTE and pregnancy loss in pregnant women with thrombophilic defects and the use of thromboprophylaxis in the prevention of VTE in patients with thrombophilia undergoing major elective orthopaedic surgery. Relevant data were summarised according to the patient groups and stratified according to the types of prophylaxis. A narrative summary was provided; where appropriate, meta-analysis was conducted. An incremental cost-effectiveness analysis was then carried out, from the perspective of the NHS in the UK. A decision analytical model was developed to simulate the clinical consequences of four thrombophilia screening scenarios. Results from the meta-analyses, information from the literature and results of two Delphi studies of clinical management of VTE and adverse pregnancy complications were incorporated into the model. Only direct health service costs were measured and unit costs for all healthcare resources used were obtained from routinely collected data and the literature. Cost-effectiveness was expressed as incremental cost-effectiveness ratios (ICERs); an estimate of the cost per adverse clinical complication prevented, comparing screening with no screening, were calculated for each patient group. RESULTS: In the review of risk of clinical complications, 81 studies were included, nine for oral oestrogen preparations, 72 for pregnancy and eight for orthopaedic surgery. For oral contraceptive use, significant associations of the risk of VTE were found in women with factor V Leiden (FVL); deficiencies of antithrombin, protein C, or protein S, elevated levels of factor VIIIc; and FVL and prothrombin G20210A. For hormone replacement therapy (HRT), a significant association was found in women with FVL. The highest risk in pregnancy was found for FVL and VTE, in particular, homozygous carriers of this mutation are 34 times more likely to develop VTE in pregnancy than non-carriers. Significant risks for individual thrombophilic defects were also established for early, recurrent and late pregnancy loss; preeclampsia; placental abruption; and intrauterine growth restriction. Significant associations were found between FVL and high factor VIIIc and postoperative VTE following elective hip or knee replacement surgery. Prothrombin G20210A was significantly associated with postoperative pulmonary embolism. However, antithrombin deficiency, MTHFR and hyperhomocysteinaemia were not associated with increased risk of postoperative VTE. In the review of the effectiveness of prophylaxis, based on available data from eight studies, low-dose aspirin and heparin was found to be the most effective in preventing pregnancy loss in thrombophilic women during pregnancy, while aspirin alone was the most effective in preventing minor bleeding. All the studies on thrombophilia and major elective orthopaedic surgery included in the review of risk complications were also used in the review of the effectiveness of thromboprophylaxis. However, there were insufficient data to determine the relative effectiveness of different thromboprophylaxis in preventing VTE in this patient group. For the cost-effectiveness analysis, of all the patient groups evaluated, universal screening of women prior to prescribing HRT was the most cost-effective (ICER pound6824). In contrast, universal screening of women prior to prescribing combined oral contraceptives was the least cost-effective strategy (ICER pound202,402). Selective thrombophilia screening based on previous personal and/or family history of VTE was more cost-effective than universal screening in all the patient groups evaluated. CONCLUSIONS: Thrombophilia is associated with increased risks of VTE in women taking oral oestrogen preparations and patients undergoing major elective orthopaedic surgery, and of VTE and adverse pregnancy outcomes in women with thrombophilia during pregnancy. There is considerable difference in the magnitude of the risks among different patient groups with different thrombophilic defects. In women who are on combined oral contraceptives, the OR of VTE among those who are carriers of the FVL mutation was 15.62 (95% confidence interval 8.66 to 28.15). However, in view of the prevalence of thrombophilia and the low prevalence of VTE in non-users of combined oral contraceptives, the absolute risk remains low. Significant risks for VTE and adverse pregnancy outcomes have been established with individual thrombophilic defects. Thrombophilic defects including FVL, high plasma factor VIIIc levels and prothrombin G20210A are associated with the occurrence of postoperative VTE in elective hip or knee replacement therapy. These associations are observed in patients who were given preoperative thromboprophylaxis and are, therefore, of clinical significance. Universal thrombophilia screening in women prior to prescribing oral oestrogen preparations, in women during pregnancy and in patients undergoing major orthopaedic surgery is not supported by current evidence. The findings from this study show that selective screening based on prior VTE history is more cost-effective than universal screening. Large prospective studies should be undertaken to refine the risks and establish the associations of thrombophilias with VTE among hormone users and in patients undergoing orthopaedic surgery. The relative value of a thrombophilia screening programme to other healthcare programmes needs to be established.