Cost-effectiveness of posterior versus anterior surgery for cervical radiculopathy: results from a multicentre randomised non-inferiority trial (FACET).

PURPOSE: For cervical nerve root compression, anterior cervical discectomy with fusion (anterior surgery) or posterior foraminotomy (posterior surgery) are safe and effective options. Posterior surgery might have a more beneficial economic profile compared to anterior surgery. The purpose of this study was to analyse if posterior surgery is cost-effective compared to anterior surgery. METHODS: An economic evaluation was performed as part of a multicentre, noninferiority randomised clinical trial (Foraminotomy ACDF Cost-effectiveness Trial) with a follow-up of 2 years. Primary outcomes were cost-effectiveness based on arm pain (Visual Analogue Scale (VAS; 0-100)) and cost-utility (quality adjusted life years (QALYs)). Missing values were estimated with multiple imputations and bootstrap simulations were used to obtain confidence intervals (CIs). RESULTS: In total, 265 patients were randomised and 243 included in the analyses. The pooled mean decrease in VAS arm at 2-year follow-up was 44.2 in the posterior and 40.0 in the anterior group (mean difference, 4.2; 95% CI, - 4.7 to 12.9). Pooled mean QALYs were 1.58 (posterior) and 1.56 (anterior) (mean difference, 0.02; 95% CI, - 0.05 to 0.08). Societal costs were €28,046 for posterior and €30,086 for the anterior group, with lower health care costs for posterior (€12,248) versus anterior (€16,055). Bootstrapped results demonstrated similar effectiveness between groups with in general lower costs associated with posterior surgery. CONCLUSION: In patients with cervical radiculopathy, arm pain and QALYs were similar between posterior and anterior surgery. Posterior surgery was associated with lower costs and is therefore likely to be cost-effective compared with anterior surgery.

Mammographic breast density and the risk of breast cancer: A systematic review and meta-analysis.

OBJECTIVES: Mammographic density is a well-defined risk factor for breast cancer and having extremely dense breast tissue is associated with a one-to six-fold increased risk of breast cancer. However, it is questioned whether this increased risk estimate is applicable to current breast density classification methods. Therefore, the aim of this study was to further investigate and clarify the association between mammographic density and breast cancer risk based on current literature. METHODS: Medline, Embase and Web of Science were systematically searched for articles published since 2013, that used BI-RADS lexicon 5th edition and incorporated data on digital mammography. Crude and maximally confounder-adjusted data were pooled in odds ratios (ORs) using random-effects models. Heterogeneity regarding breast cancer risks were investigated using I2 statistic, stratified and sensitivity analyses. RESULTS: Nine observational studies were included. Having extremely dense breast tissue (BI-RADS density D) resulted in a 2.11-fold (95% CI 1.84-2.42) increased breast cancer risk compared to having scattered dense breast tissue (BI-RADS density B). Sensitivity analysis showed that when only using data that had adjusted for age and BMI, the breast cancer risk was 1.83-fold (95% CI 1.52-2.21) increased. Both results were statistically significant and homogenous. CONCLUSIONS: Mammographic breast density BI-RADS D is associated with an approximately two-fold increased risk of breast cancer compared to having BI-RADS density B in general population women. This is a novel and lower risk estimate compared to previously reported and might be explained due to the use of digital mammography and BI-RADS lexicon 5th edition.

Cost-effectiveness and budget impact of a lifestyle intervention to improve cardiometabolic health in patients with severe mental illness.

Introduction: This study assessed the cost-effectiveness and budget impact of a lifestyle intervention to improve cardiometabolic health in severe mentally ill (SMI) patients in the LION trial. Methods: Patients (n = 244) were randomized to receive either care-as-usual or a lifestyle intervention in which mental health nurses coached patients in changing their lifestyle by using a web tool. Costs and quality of life were assessed at baseline and at 6 and 12 months. Incremental costs per centimeter waist circumference (WC) lost and per Quality-Adjusted Life Year (QALY) gained were assessed. Budget impact was estimated based on three intervention-uptake scenarios using a societal and a third-party payer perspective. Results: Costs and reduction in WC were higher in the intervention (n = 114) than in the control (n = 94) group after 12 months, although not statistically significant, resulting in €1,370 per cm WC lost. QALYs did not differ between the groups, resulting in a low probability of the intervention being cost-effective in cost/QALY gained. The budget impact analysis showed that for a reasonable participation of 43%, total costs were around €81 million over 5 years, or on average €16 million annually (societal perspective). Conclusions: The intervention is not cost-effective at 12 months and the budget impact over 5 years is substantial. Possibly, 12 months was too short to implement the intervention, improve cardiometabolic health, and reduce care costs. Therefore, the incentive for this intervention cannot be found in short-term financial advantages. However, there may be benefits associated with lifestyle interventions in the long term that remain unclear.

Nurse-led vs. usual-care for atrial fibrillation.

BACKGROUND: Nurse-led integrated care is expected to improve outcome of patients with atrial fibrillation compared with usual-care provided by a medical specialist. METHODS AND RESULTS: We randomized 1375 patients with atrial fibrillation (64 ± 10 years, 44% women, 57% had CHA2DS2-VASc ≥ 2) to receive nurse-led care or usual-care. Nurse-led care was provided by specialized nurses using a decision-support tool, in consultation with the cardiologist. The primary endpoint was a composite of cardiovascular death and cardiovascular hospital admissions. Of 671 nurse-led care patients, 543 (81%) received anticoagulation in full accordance with the guidelines against 559 of 683 (82%) usual-care patients. The cumulative adherence to guidelines-based recommendations was 61% under nurse-led care and 26% under usual-care. Over 37 months of follow-up, the primary endpoint occurred in 164 of 671 patients (9.7% per year) under nurse-led care and in 192 of 683 patients (11.6% per year) under usual-care [hazard ratio (HR) 0.85, 95% confidence interval (CI) 0.69 to 1.04, P = 0.12]. There were 124 vs. 161 hospitalizations for arrhythmia events (7.0% and 9.4% per year), and 14 vs. 22 for heart failure (0.7% and 1.1% per year), respectively. Results were not consistent in a pre-specified subgroup analysis by centre experience, with a HR of 0.52 (95% CI 0.37-to 0.71) in four experienced centres and of 1.24 (95% CI 0.94-1.63) in four less experienced centres (P for interaction <0.001). CONCLUSION: Our trial failed to show that nurse-led care was superior to usual-care. The data suggest that nurse-led care by an experienced team could be clinically beneficial (ClinicalTrials.gov NCT01740037). TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT01740037).

Group schema-focused therapy enriched with psychomotor therapy versus treatment as usual for older adults with cluster B and/or C personality disorders: a randomized trial.

BACKGROUND: Several types of psychotherapy have been proven successful in the treatment of personality disorders in younger age groups, however studies among older patients are lacking. We developed a group schema-focused therapy (SFT) enriched with psychomotor therapy (PMT) for older adults with cluster B and/or C personality disorders. This paper describes the design of a randomized controlled trial (RCT). We will evaluate the (cost-)effectiveness of this therapy protocol in specialized mental health care. We hypothesize that our treatment program is cost-effective and superior to treatment as usual (TAU) in reducing psychological distress and improving quality of life in older adults treated to specialized mental healthcare. METHODS: A multicenter RCT with a one-year follow-up comparing group schema-focused therapy enriched with psychomotor therapy (group SFT + PMT) and TAU for adults aged 60 years and older who suffer from either a cluster B and/or C personality disorder. The primary outcome is general psychological distress measured with the 53-item Brief Symptom Inventory. Secondary outcomes are the Schema Mode Inventory (118-item version) and the Young Schema Questionnaire. Cost-effectiveness analysis will be performed from a societal perspective with the EuroQol five dimensions questionnaire and structured cost-interviews. DISCUSSION: This study will add to the knowledge of psychotherapy in later life. The study specifically contributes to the evidence on (cost-) effectiveness of group SFT enriched with PMT adapted to the needs of for older adults with cluster b and/or c personality. TRIAL REGISTRATION: Netherlands Trial Register NTR 6621 . Registered on 20 August 2017.

Cost-Effectiveness of Scaling Up Modern Family Planning Interventions in Low- and Middle-Income Countries: An Economic Modeling Analysis in Indonesia and Uganda.

OBJECTIVES: The aim was to estimate the long-term cost-effectiveness of improved family planning interventions to reduce the unmet need in low- and middle-income countries, with Indonesia and Uganda as reference cases. METHODS: The analysis was performed using a Markov decision analytic model, where current situation and several scenarios to reduce the unmet need were incorporated as the comparative strategies. Country-specific evidence was synthesized from the demographic and health survey and published studies. The model simulated the sexual and reproductive health experience of women in the reproductive age range over a time horizon of women's reproductive years, from the healthcare payer perspective. Modeled outcomes included clinical events, costs and incremental cost-effectiveness ratios (ICERs) expressed as cost per disability-adjusted life year (DALY) averted. Deterministic and probabilistic sensitivity analyses were conducted to assess the impact of parameter uncertainty on modeled outcomes. RESULTS: In the hypothetical cohort of 100,000 women, scenarios to reduce the unmet need for family planning would result in savings within a range of US$230,600-US$895,100 and US$564,400-US$1,865,900 in Indonesia and Uganda, respectively. The interventions would avert an estimated 1859-3780 and 3705-12,230 DALYs in Indonesia and Uganda, respectively. The results of our analysis indicate that scaling up family planning dominates the current situation in all scenarios in both countries, with lower costs and fewer DALYs. These results were robust in sensitivity analyses. CONCLUSION: Scaling up family planning interventions could improve women's health outcomes substantially and be cost-effective or even cost saving across a range of scenarios compared to the current situation.

Cost-utility analysis of high-dose treatment for intermediate-susceptible, dose-dependent tuberculosis patients.

SETTING: We proposed to: 1) introduce an intermediate-susceptible, dose-dependent (ISDD) category for Mycobacterium tuberculosis infection; and 2) treat patients with M. tuberculosis infection in this category with a high dose of rifampicin (RMP) and isoniazid (INH). OBJECTIVE: To examine the impact of our strategy on quality-adjusted life-years (QALY) and costs in a low-income country with a high prevalence of multidrug-resistant tuberculosis (MDR-TB) (Belarus) and a high-income, low MDR-TB prevalence country (The Netherlands). DESIGN: A Markov model comprising 14 health states was used to simulate treatment outcomes and costs accrued over 5 years for a hypothetical cohort of 10 000 patients. One-way sensitivity analysis, probabilistic sensitivity analysis and a scenario analysis were also performed. RESULTS: Our strategy was shown to be cost-effective for Belarus, but not for the Netherlands. At a willingness-to-pay of 50 000 euros per QALY, the probability of our strategy being cost-effective was 50% for the Netherlands and 57% for Belarus. CONCLUSION: The study shows that our strategy could be cost-effective and more efficacious. However, more studies are needed on the outcomes of using higher doses of INH and RMP.

Study protocol for a randomised controlled multicentre study: the Foraminotomy ACDF Cost-Effectiveness Trial (FACET) in patients with cervical radiculopathy.

INTRODUCTION: Cervical radiculopathy due to discogenic or spondylotic stenosis of the neuroforamen can be surgically treated by an anterior discectomy with fusion (ACDF) or a posterior foraminotomy (FOR). Most surgeons prefer ACDF, although there are indications that FOR is as effective as ACDF, has a lower complication rate and is less expensive. A head-to-head comparison of the 2 surgical techniques in a randomised controlled trial has not yet been performed. The study objectives of the Foraminotomy ACDF Cost-Effectiveness Trial (FACET) study are to compare clinical outcomes, complication rates and cost-effectiveness of FOR to ACDF. METHODS AND ANALYSIS: The FACET study is a prospective randomised controlled trial conducted in 7 medical centres in the Netherlands. The follow-up period is 2 years. The main inclusion criterion is a radiculopathy of the C4, C5, C6 or C7 nerve root, due to a single-level isolated cervical foraminal stenosis caused by a soft disc and/or osteophytic component, requiring operative decompression. A sample size of 308 patients is required to test the hypothesis of clinical non-inferiority of FOR versus ACDF. Primary outcomes are: 'operative success', the measured decrease in radiculopathy assessed by the visual analogue scale and 'patient success', assessed by the modified Odom's criteria. Secondary outcomes are: Work Ability Index (single-item WAI), quality of life (EuroQol 5 Dimensions 5 level Survey, EQ-5D-5L), Neck Disability Index (NDI) and complications. An economic evaluation will assess cost-effectiveness. In addition, a budget impact analysis will be performed. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Institutional Ethics Committee of the University Medical Center Groningen. Results of this study will be disseminated through national and international papers. The participants and relevant patient support groups will be informed about the results of the study. TRIAL REGISTRATION NUMBER: NTR5536, pre-results.

Ulipristal acetate for pre-operative treatment of moderate-to-severe uterine fibroids in women of reproductive age in The Netherlands: cost minimization analysis and budget impact analysis.

OBJECTIVE: Ulipristal acetate has been found to be non-inferior to other pre-operative treatments of uterine fibroids, particularly leuprolide. The objective of this study was to assess the pharmacoeconomic profile of ulipristal acetate compared to leuprolide for the pre-operative treatment of moderate-to-severe uterine fibroids in women of reproductive age in The Netherlands. The analysis was performed and applied within the framework of the ulipristal acetate submission for reimbursement in 2012. METHODS: A decision model was developed to compare the total costs of ulipristal acetate compared to leuprolide, the standard care in The Netherlands. The target population of this study corresponded to the type of patients included in the PEARL II clinical trial; i.e. women of reproductive age requiring pre-operative treatment for uterine fibroids. Sensitivity analysis was implemented to assess uncertainties. Data regarding costs, effects, and other input parameters were obtained from relevant published literatures, the Dutch Healthcare Insurance Board, and expert opinion obtained by means of a panel of experts from several medical centers in The Netherlands. RESULTS: In The Netherlands, the total costs of ulipristal acetate and leuprolide were estimated at €4,216,027 and €4,218,095, respectively. The annual savings of ulipristal acetate were, therefore, estimated at €2,068. The major driver of this cost difference was the cost of administration for leuprolide. Sensitivity analyses showed that ulipristal acetate mostly remained cost-saving over a range of assumptions. The budget impact analysis indicated that the introduction of ulipristal acetate was estimated to result in cost savings in the first 3 years following the introduction. The results of this study were used in the decision on reimbursement of ulipristal acetate according to the Dutch Reference Pricing system in 2012. CONCLUSION: Ulipristal acetate was cost saving compared to leuprolide and has the potential to provide substantial savings on the healthcare budget in The Netherlands.

Cost-effectiveness of embryo transfer strategies: a decision analytic model using long-term costs and consequences of singletons and multiples born as a consequence of IVF.

STUDY QUESTION: What is the cost-effectiveness of elective single embryo transfer (eSET) versus double embryo transfer (DET) strategies from a societal perspective, when applying a time horizon of 1, 5 and 18 years? SUMMARY ANSWER: From a short-term perspective (1 year) it is cost-effective to replace DET with single embryo transfer; however when intermediate- (5 years) and long-term (18 years) costs and consequences are incorporated, DET becomes the most cost-effective strategy, given a ceiling ratio of €20 000 per quality-adjusted life years (QALY) gained. WHAT IS ALREADY KNOWN: According to previous cost-effectiveness research into embryo transfer strategies, DET is considered cost-effective if society is willing to pay around €20 000 for an extra live birth. However, interpretation of those studies is complicated, as those studies fail to incorporate long-term costs and outcomes and used live birth as a measure of effectiveness instead of QALYs. With this outcome, both multiple and singletons were valued as one live birth, whereas costs of all children of a multiple were incorporated. STUDY DESIGN, SIZE, DURATION: A Markov model (cycle length: 1 year; time horizon: 1, 5 and 18 years) was developed comparing a maximum of: (i) three cycles of eSET in all patients; (ii) four cycles of eSET in all patients; (iii) five cycles of eSET in all patients; (iv) three cycles of standard treatment policy (STP), i.e. eSET in women <38 years with a good quality embryo, and DET in all other women; and (v) three cycles of DET in all patients. PARTICIPANTS/MATERIALS, SETTING, METHODS: Expected life years (LYs), child QALYs and costs were estimated for all comparators. Input parameters were derived from a retrospective cohort study, in which hospital resource data were collected (n=580) and a parental questionnaire was sent out (431 respondents). Probabilistic sensitivity analysis (5000 iterations) was performed. MAIN RESULTS AND THE ROLE OF CHANCE: With a time horizon of 18 years, DETx3 is most effective (0.54 live births, 10.2 LYs and 9.8 QALYs) and expensive (€37 871) per couple starting IVF. Three cycles of eSET are least effective (0.43 live births, 7.1 LYs and 6.8 QALYs) and expensive (€25 563). We assumed that society is willing to pay €20 000 per QALY gained. With a time horizon of 1 year, eSETx3 was the most cost-effective embryo transfer strategy with a probability of being cost-effective of 99.9%. With a time horizon of 5 or 18 years, DETx3 was most cost-effective, with probabilities of being cost-effective of 77.3 and 93.2%, respectively. LIMITATIONS, REASONS FOR CAUTION: This is the first study to use QALYs generated by the children in the economic evaluation of embryo transfer strategies. There remains some disagreement on whether QALYs generated by new life should be used in economic evaluations of fertility treatment. A further limitation is that treatment ends when it results in live birth and that only child QALYs were considered as measure of effectiveness. The results for the time horizon of 18 years might be less solid, as the data beyond the age of 8 years are based on extrapolation. WIDER IMPLICATIONS OF THE FINDINGS: The current Markov model indicates that when child QALYs are used as measure of outcome it is not cost-effective on the long term to replace DET with single embryo transfer strategies. However, for a balanced approach, a family-planning perspective would be preferable, including additional treatment cycles for couples who wish to have another child. Furthermore, the analysis should be extended to include QALYs of family members. STUDY FUNDING/COMPETING INTERESTS: This study was supported by a research grant (grant number 80-82310-98-09094) from the Netherlands Organization for Health Research and Development (ZonMw). There are no conflicts of interest in connection with this article. TRIAL REGISTRATION NUMBER: Not applicable.

[Cost-effectiveness of psychotherapy for personality disorders. A systematic review on economic evaluation studies]. / Kosteneffectiviteit van psychotherapie voor persoonlijkheidsstoornissen; een systematisch literatuuronderzoek van economische evaluatiestudies.

BACKGROUND: So far, there has not been a complete overview of the cost-effectiveness of psychotherapy for patients with a personality disorder.
AIM: To provide an overview of scientific literature on the cost-effectiveness of psychotherapy for patients with a personality disorder.
METHOD: We reviewed the literature systematically, searching the NHS EED, PubMed and PsycINFO databases. We concentrated solely on full economic evaluations of treatments in which all patients had a personality disorder.
RESULTS: Most studies concluded that at least one of the psychotherapeutic treatments investigated was cost-effective. Dialectical behavior therapy was studied the most; schema therapy came next, followed by cognitive behavioural therapy.
CONCLUSION: In general, scientific evidence indicates that psychotherapeutic treatments for patients with personality disorders are cost-effective relative to the comparator treatments. This is important information because it can influence decisions on whether the costs of psychotherapy should be reimbursed.

Cost-effectiveness of supervised exercise therapy compared with endovascular revascularization for intermittent claudication.

BACKGROUND: Current guidelines recommend supervised exercise therapy (SET) as the preferred initial treatment for patients with intermittent claudication. The availability of SET programmes is, however, limited and such programmes are often not reimbursed. Evidence for the long-term cost-effectiveness of SET compared with endovascular revascularization (ER) as primary treatment for intermittent claudication might aid widespread adoption in clinical practice. METHODS: A Markov model was constructed to determine the incremental costs, incremental quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratio of SET versus ER for a hypothetical cohort of patients with newly diagnosed intermittent claudication, from the Dutch healthcare payer's perspective. In the event of primary treatment failure, possible secondary interventions were repeat ER, open revascularization or major amputation. Data sources for model parameters included original data from two RCTs, as well as evidence from the medical literature. The robustness of the results was tested with probabilistic and one-way sensitivity analysis. RESULTS: Considering a 5-year time horizon, probabilistic sensitivity analysis revealed that SET was associated with cost savings compared with ER (-€6412, 95 per cent credibility interval (CrI) -€11 874 to -€1939). The mean difference in effectiveness was -0·07 (95 per cent CrI -0·27 to 0·16) QALYs. ER was associated with an additional €91 600 per QALY gained compared with SET. One-way sensitivity analysis indicated more favourable cost-effectiveness for ER in subsets of patients with low quality-of-life scores at baseline. CONCLUSION: SET is a more cost-effective primary treatment for intermittent claudication than ER. These results support implementation of supervised exercise programmes in clinical practice.

A review of economic evaluation models for cardiac resynchronization therapy with implantable cardioverter defibrillators in patients with heart failure.

OBJECTIVES: Cardiac resynchronization therapy with a biventricular pacemaker (CRT-P) is an effective treatment for dyssynchronous heart failure (DHF). Adding an implantable cardioverter defibrillator (CRT-D) may further reduce the risk of sudden cardiac death (SCD). However, if the majority of patients do not require shock therapy, the cost-effectiveness ratio of CRT-D compared to CRT-P may be high. The objective of this study was to systematically review decision models evaluating the cost-effectiveness of CRT-D for patients with DHF, compare the structure and inputs of these models and identify the main factors influencing the ICERs for CRT-D. METHODS: A comprehensive search strategy of Medline (Ovid), Embase (Ovid) and EconLit identified eight cost-effectiveness models evaluating CRT-D against optimal pharmacological therapy (OPT) and/or CRT-P. RESULTS: The selected economic studies differed in terms of model structure, treatment path, time horizons, and sources of efficacy data. CRT-D was found cost-effective when compared to OPT but its cost-effectiveness became questionable when compared to CRT-P. CONCLUSIONS: Cost-effectiveness of CRT-D may increase depending on improvement of all-cause mortality rates and HF mortality rates in patients who receive CRT-D, costs of the device, and battery life. In particular, future studies need to investigate longer-term mortality rates and identify CRT-P patients that will gain the most, in terms of life expectancy, from being treated with a CRT-D.

Methodological considerations in service use assessment for children and youth with mental health conditions; issues for economic evaluation.

Economic evaluations are increasingly used in decision-making. Accurate measurement of service use is critical to economic evaluation. This qualitative study, based on expert interviews, aims to identify best approaches to service use measurement for child mental health conditions, and to identify problems in current methods. Results suggest considerable agreement on strengths (e.g., availability of accurate instruments to measure service use) and weaknesses, (e.g., lack of unit prices for services outside the health sector) or alternative approaches to service use measurement. Experts also identified some unresolved problems, for example the lack of uniform definitions for some mental health services.

Rapid fetal fibronectin testing to predict preterm birth in women with symptoms of premature labour: a systematic review and cost analysis.

BACKGROUND: Premature birth is defined as birth of before 37 completed weeks' gestation. Not all pregnant women showing symptoms of preterm labour will go on to deliver before 37 weeks' gestation. Hence, addition of fetal fibronectin (fFN) testing to the diagnostic workup of women with suspected preterm labour may help to identify those women who do not require active management, and thus avoid unnecessary interventions, hospitalisations and associated costs. OBJECTIVE: To assess the clinical effectiveness and cost-effectiveness of rapid fFN testing in predicting preterm birth (PTB) in symptomatic women. DATA SOURCES: Bibliographic databases (including EMBASE, Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials) were searched from 2000 to September/November 2011. Trial registers were also searched. REVIEW METHODS: Systematic review methods followed published guidance; we assessed clinical effectiveness and updated a previous systematic review of test accuracy. Risk of bias was assessed using the Cochrane tool (randomised controlled trials; RCTs) and a modification of QUADAS-2 (diagnostic test accuracy studies; DTAs). Summary risk ratios or weighted mean difference were calculated using random-effects models. Summary sensitivity and specificity used a bivariate summary receiver operating characteristic model. Heterogeneity was investigated using subgroup and sensitivity analyses. Health economic analysis focused on cost consequences. The time horizon was hospital admission for observation. A main structural assumption was that, compared with usual care, fFN testing doesn't increase adverse events or negative pregnancy outcomes. RESULTS: Five RCTs and 15 new DTAs were identified. No RCT reported significant effects of fFN testing on maternal or neonatal outcomes. One study reported a subgroup analysis of women with negative fFN test observed > 6 hours, which showed a reduction in length of hospital stay where results were known to clinicians. Combining data from new studies and the previous systematic review, the pooled estimates of sensitivity and specificity were: 76.7% and 82.7% for delivery within 7-10 days of testing; 69.1% and 84.4% for delivery < 34 weeks' gestation; and 60.8% and 82.3% for delivery < 37 weeks' gestation. Estimates were similar across all subgroups sensitivity analyses. The base-case cost analysis resulted in a cost saving of £23.87 for fFN testing compared with usual care. The fFN testing was cost-neutral at an approximate cost of £45. Probabilistic sensitivity analysis gave an incremental cost (saving) of -£25.59 (97.5% confidence interval -£304.96 to £240.06), indicating substantial uncertainty. Sensitivity analyses indicated that admission rate had the largest impact on results. CONCLUSIONS: Fetal fibronectin testing has moderate accuracy for predicting PTB. The main potential role is likely to be reducing health-care resource usage by identifying women not requiring intervention. Evidence from RCTs suggests that fFN does not increase adverse outcomes and may reduce resource use. The base-case analysis showed a modest cost difference in favour of fFN testing, which is largely dependent on whether or not fFN testing reduces hospital admission. Currently, there are no high-quality studies and the existing trials were generally underpowered. Hence, there is a need for high-quality adequately powered trials using appropriate study designs to confirm the findings presented. STUDY REGISTRATION: PROSPERO 2011:CRD42011001468. Available from www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42011001468. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Cost-effectiveness analysis of sacral neuromodulation for faecal incontinence in The Netherlands.

AIM: Sacral neuromodulation (SNM) plays a major part in the algorithm of management of faecal incontinence, but there are limited data on its cost-effectiveness. This study aimed to analyse this and the quality-adjusted life-years (QALYs) associated with two different treatment algorithms. The first (SNM-) included use of an artificial sphincter [dynamic graciloplasty (DGP) (50%) and artificial bowel sphincter (ABS) (50%)]. The second (SNM+) included SNM (80% of cases) and artificial sphincter (DGP 10%; ABS 10%) The incidence of sphincteroplasty was assumed to be equal in both algorithms. METHOD: A Markov model was developed. A hypothetical cohort of patients was run through both strategies of the model. A mailed EuroQoL-5D questionnaire was used to determine health-related quality of life. Costs were reproduced from the Maastricht University Medical Centre prospective faecal incontinence database. The time scale of the analysis was 5 years. RESULTS: The former treatment protocol cost €22,651 per patient and the latter, after the introduction of SNM, cost €16,473 per patient. The former treatment protocol resulted in a success rate of 0.59 after 5 years, whereas with the introduction of SNM this was 0.82. Adhering to the former treatment protocol yielded 4.14 QALYs and implementing the latter produced 4.21 QALYs. CONCLUSION: The study demonstrated that introducing SNM in the surgical management algorithm for faecal incontinence was both more effective and less costly than DGP or ABS without SNM. This justifies adequate funding for SNM for patients with faecal incontinence.

Cost-effectiveness of exercise therapy in patients with intermittent claudication: supervised exercise therapy versus a 'go home and walk' advice.

OBJECTIVES: The Exercise Therapy in Peripheral Arterial Disease (EXITPAD) study has shown supervised exercise therapy (SET) to be more effective regarding walking distance and quality of life than a 'go home and walk' advice (WA) for patients with intermittent claudication. The present study aims to assess the cost-effectiveness of SET versus WA. PATIENTS AND METHODS: Data from the EXITPAD study, a 12-month randomised controlled trial in 304 patients with claudication, was used to study the proportion of costs to walking distance and quality of life. Two different incremental cost-effectiveness ratios (ICERs) were calculated for SET versus WA: costs per extra metre on the treadmill test, and costs per quality-adjusted life year (QALY). QALYs were based on utilities derived from the EuroQoL-5 dimensions (EQ-5D). RESULTS: Mean total costs were higher for SET than for WA (3407 versus 2304 Euros), mainly caused by the costs of exercise therapy. The median walking distance was 620 m for SET and 400 m for WA. QALYs were 0.71 for SET and 0.67 for WA. All differences were statistically significant. The ICER for cost per extra metre on the 12-month treadmill test was € 4.08. For cost per QALY, the ICER was € 28,693. CONCLUSION: At a willingness-to-pay threshold of € 40,000 per QALY, SET likely is a cost-effective therapeutic option for patients with claudication.

Surgical site infections: how high are the costs?

There is an increased interest in prevention of nosocomial infections and in the potential savings in healthcare costs. The aim of this review of recent studies on surgical site infections (SSIs) was to compare methods of cost research and magnitudes of costs due to SSI. The studies reviewed differ greatly with regard to study design and methods for cost calculation. However, healthcare costs for a patient with SSI are, on average, approximately twice the amount of costs for a patient without an SSI.