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Aim: Sacral neuromodulation (SNM) is a minimally invasive treatment option for functional constipation. Evidence regarding its effectiveness is contradictory, driven by heterogeneous study populations and designs. The aim of this study was to assess the effectiveness, safety and cost‐effectiveness of SNM in children and adults with refractory idiopathic slow‐transit constipation (STC). Method: OVID Medline, OVID Embase, Cochrane Library, the KSR Evidence Database, the NHS Economic Evaluation Database and the International HTA Database were searched up to 25 May 2023. For effectiveness outcomes, randomized controlled trials (RCTs) were selected. For safety outcomes, all study designs were selected. For cost‐effectiveness outcomes, trial‐ and model‐based economic evaluations were selected for review. Study selection, risk of bias and quality assessment, and data extraction were independently performed by two reviewers. For the intervention 'sacral neuromodulation' effectiveness outcomes included defaecation frequency and constipation severity. Safety and cost‐effectiveness outcomes were, respectively, adverse events and incremental cost‐effectiveness ratios. Results: Of 1390 records reviewed, 67 studies were selected for full‐text screening. For effectiveness, one cross‐over and one parallel‐group RCT was included, showing contradictory results. Eleven studies on safety were included (four RCTs, three prospective cohort studies and four retrospective cohort studies). Overall infection rates varied between 0% and 22%, whereas reoperation rates varied between 0% and 29%. One trial‐based economic evaluation was included, which concluded that SNM was not cost‐effective compared with personalized conservative treatment at a time horizon of 6 months. The review findings are limited by the small number of available studies and the heterogeneity in terms of study populations, definitions of refractory idiopathic STC and study designs. Conclusion: Evidence for the (cost‐)effectiveness of SNM in children and adults with refractory idiopathic STC is inconclusive. Reoperation rates of up to 29% were reported. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the cost‐effectiveness of Descemet Membrane Endothelial Keratoplasy (DMEK) versus Ultrathin Descemet Stripping Automated Endothelial Keratoplasty (UT‐DSAEK). Methods: A cost‐effectiveness analysis using data from a multicenter randomized clinical trial was performed. The time horizon was 12 months postoperatively. Patients with Fuchs' endothelial dystrophy were randomized to DMEK (n = 29) or UT‐DSAEK (n = 24). Relevant resources from healthcare and societal perspectives were included in the cost analysis. Quality‐Adjusted Life Years (QALYs) were determined using the Health Utilities Index Mark 3 (HUI3) and the EuroQol EQ‐5D‐5L questionnaires. The main outcome was the incremental cost‐effectiveness ratio (ICER; incremental societal costs per QALY). Results: Societal costs averaged €8851 (US$11 406) for DMEK and €8320 (US$10 722) for UT‐DSAEK. Higher costs in the DMEK group were mainly caused by higher rebubbling and regraft rates (21% and 7%, vs. 4% and 0% in the UT‐DSAEK group). HUI3 QALYs were 0.70 (DMEK) and 0.79 (UT‐DSAEK). EQ‐5D‐5L QALYs were 0.83 (DMEK) and 0.86 (UT‐DSAEK). The ICER indicated DMEK was dominated by UT‐DSAEK in both analyses. The cost‐effectiveness probability for DMEK ranged from 21% to 5% (HUI3 QALYs) and 27%–14% (EQ‐5D‐5L QALYs), assuming the maximum acceptable ICER ranged from €2500 to €80.000 (US$3222–US$103 093) per QALY. Conclusion: The base case cost‐effectiveness analysis favoured UT‐DSAEK over DMEK, as costs of DMEK were higher while QALYs were lower. Further studies are required to assess long‐term rebubbling and regraft rates and graft survival. [ABSTRACT FROM AUTHOR]

Background: Trabeculectomy is the "gold standard" initial surgical procedure for open-angle glaucoma worldwide. During the last decade, the introduction of less invasive procedures, including new bleb-forming surgery such as the MicroShunt, has altered the approach of glaucoma management. At present, there is insufficient evidence comparing the effectiveness between these procedures nor versus trabeculectomy. Furthermore, there is no data available on patient impact and cost-effectiveness. This study aims to address this gap in evidence and establish whether MicroShunt implantation is non-inferior compared to trabeculectomy with regard to effectiveness and whether it is cost-effective. Methods: A multicentre, non-inferiority, randomised controlled trial (RCT) studying open-angle glaucoma with an indication for surgery will be conducted. Patients with previous ocular surgery except for phacoemulsification are excluded, as are patients with ocular comorbidity compromising the visual field or requiring a combined procedure. After informed consent is obtained, patients will be randomly allocated to the intervention, a PRESERFLO™ MicroShunt implantation, or the control group, trabeculectomy, using block randomisation (blocks of 2, 4 or 6 patients). In total, 124 patients will be randomised in a 1:1 ratio, stratified by centre. The primary endpoint will be intraocular pressure (IOP) one year after surgery. Secondary outcomes include IOP-lowering medication use, treatment failure, visual acuity, visual field progression, additional interventions, adverse events, patient-reported outcome measures (PROMs), and cost-effectiveness. Study outcomes will be measured up to 12 months postoperatively. Discussion: This study protocol describes the design of a multicentre non-inferiority randomised controlled trial. To this date, cost-effectiveness studies evaluating the MicroShunt have not been undertaken. This multicentre RCT will provide more insight into whether MicroShunt implantation is non-inferior compared to standard trabeculectomy regarding postoperative IOP and whether MicroShunt implantation is cost-effective. Trial registration: ClinicalTrials.gov, Identifier: NCT03931564, Registered 30 April 2019. [ABSTRACT FROM AUTHOR]

Introduction: Stakeholders are increasingly interested in the societal impact of psychosocial interventions in the youth sector, in terms of costs and quality of life, as well as in outcomes research. The aim of this broad consulta- tion was to reach consensus regarding the steps to be undertaken to set a research agenda for the Netherlands Organisation for Health Research and Development (ZonMw) programme. Methods: The broad consultation consisted of an eight-step procedure, including the conceptualization of a consultation document consisting of a scoping review of (mainly) international opinion/methodological literature and an inventory of existing Dutch guidelines and manuals for economic evaluation, a written consultation procedure among a broad range of stakeholders, and a consultation meeting with these stakeholders. Results: In total 21 documents were included in the scoping review. A total of 24 stakeholders participated in the written consultation procedure and 14 stakeholders during the consultation meeting. The methodological issues and challenges, which were ranked in the top 5 by the stakeholders, are (i) outcome measurement, (ii) outcome identification, (iii) cost valuation, (iv) outcome valuation, and (v) time horizon/analytical approach. The existing guidelines and manuals provided guidance for some, but not all, issues and challenges. Discussion and Conclusion: This broad consultation has contributed to a research agenda for the ZonMw programme, which will in the long run lead to the standardization of economic evaluations in this sector in the Netherlands and methodological improvement of economic evaluations in the Dutch youth sector. [ABSTRACT FROM AUTHOR]

Objectives: Differences between country-specific guidelines for economic evaluations complicate the execution of international economic evaluations. The aim of this study was to develop cross-European recommendations for the identification, measurement and valuation of resource use and lost productivity in economic evaluations using a Delphi procedure.Methods: A comprehensive literature search was conducted to identify European guidelines on the execution of economic evaluations or costing studies as part of economic evaluations. Guideline recommendations were extracted by two independent reviewers and formed the basis for the first round of the Delphi study, which was conducted among European health economic experts. During three written rounds, consensus (agreement of 67% or higher) was sought on items concerning the identification, measurement and valuation of costs.Results: Recommendations from 18 guidelines were extracted. Consensus among 26 panellists from 17 European countries was reached on 61 of 68 items. The recommendations from the Delphi study are to adopt a societal perspective, to use patient report for measuring resource use and lost productivity, to value both constructs with use of country-specific standardized/unit costs and to use country-specific discounting rates.Conclusion: This study provides consensus-based cross-European recommendations on how to measure and value resource use and lost productivity in economic evaluations. These recommendations are expected to support researchers, healthcare professionals, and policymakers in executing and appraising economic evaluations performed in international contexts. [ABSTRACT FROM AUTHOR]

Rationale, aims, and objectives Sustainability of innovations is a relatively new concept in health care research and has become an issue of growing interest. The current study explored factors related to the sustainability of 2 multidisciplinary hospital-based programs 3 to 6 years after achieving early implementation success. Method An exploratory qualitative study was conducted into 2 implementation cases, an Enhanced Recovery After Surgery program for colorectal surgery and a short-stay program for breast cancer surgery. Semistructured interviews were held with key persons involved in the care process in 14 hospitals from both cases minimally 3 years after the implementation, between March 2012 and May 2013. The Consolidated Framework for Implementation Research was used to direct the development of the interview guide, during data collection and during analysis. A directed content analysis was performed. Results A total of 21 interviews with 26 individuals were held, 18 regarding the Enhanced Recovery After Surgery case and 8 regarding the short-stay program case. Respondents mentioned the following factors associated with sustainability of the programs: modification and adaptability of the program, cost-effectiveness, institutionalization into existing systems, short communication lines within the multidisciplinary team, an innovative culture, benefits for patients, cosmopolitanism, the existence of external policies and incentives, trust and belief in the program, and spread of the program to other settings. Two factors are not covered by the Consolidated Framework for Implementation Research, ie, modification of the program over the years and spread of the program to other contexts. Conclusions The factors associated with sustainability put forward in both cases were largely the same. Leadership and the implementation project were not mentioned as having influenced the long-term sustainability of the benefits achieved. Sustainability of the innovations is influenced by determinants stemming from all ecological levels of the health care system and demands continuous effort in the postimplementation phase. [ABSTRACT FROM AUTHOR]

Background: Low back pain (LBP) is a common health problem and a substantial part of LBP is presumed to be attributable to degeneration of the intervertebral disc. For patients suffering from intractable discogenic LBP, there are few evidence-based effective interventional treatment options available. In 2010, the results of a randomized controlled trial (RCT) were published concerning "intradiscal methylene blue injection" (IMBI), in which this intervention appeared to be very successful in relieving discogenic pain. Therefore, we decided to repeat this study to investigate whether we could replicate the published results. The results of our preliminary feasibility study gave reason to set up an RCT. The aim of this RCT is to evaluate if IMBI is a more effective treatment of discogenic low back pain as an intradiscal placebo intervention, and furthermore, to assess the cost-effectiveness of this intervention.Methods/design: Consecutive discogenic low back pain patients referred to four specialized pain treatment facilities are being screened for eligibility. After a positive standardized provocation discography and informed consent, patients are randomized into two groups. The treatment group receives an intradiscal injection with methylene blue, lidocaine, and contrast, and the control group receives intradiscal isotonic saline with lidocaine and contrast. Main outcome measures are pain at the 6-month follow-up, patient's global impression of change, cost-effectiveness, quality of life, disability, and analgesic intake.Discussion: The importance of this study is emphasized by the fact that for intractable discogenic low back pain patients, evidence-based effective pain treatments are rare. If this study establishes clinical success and cost-effectiveness, IMBI could become the "pain treatment of choice" for a selected group of patients with chronic discogenic low back pain for whom noninvasive treatment options have failed.Trial Registration: National Trial register NTR2547 Registered at 29 September 2010 and 31 March 2014. [ABSTRACT FROM AUTHOR]

Anxiety in children is highly frequent and causes severe dysfunction. Various studies have used screening procedures to identify high-anxious children and offer them indicated prevention, but the cost-effectiveness of these screening procedures in combination with a preventive intervention has never been examined. This study compared four potential strategies in relation to the prevention of child anxiety: (1) a one-time school-based screening which offers a child-focused intervention, (2) the screening and offering of a parent-focused intervention, (3) the screening and differentially offering a child- or parent-focused intervention, depending on whether or not the parents are anxious themselves, and (4) or doing nothing. An economic evaluation from a societal perspective (i.e. including direct healthcare costs, direct non-healthcare costs, indirect costs, and out-of-pocket costs), using a decision-analytic model. The model was based on the real-world 2-year participation rates of screening and intervention, and real-world costs and effects of high- and median-anxious children (aged 8-12) from regular primary schools. Incremental cost-effectiveness ratios were calculated, and several secondary and one-way sensitivity analyses were performed. The strategy of doing nothing and the strategy of screening and differentially offering the child- or parent-focused intervention, depending on parental anxiety levels were both worthwhile, with the latter strategy costing relatively little extra money compared to doing nothing. In conclusion, some evidence for the cost-effectiveness of screening and intervening was found. Screening and offering a parent-focused intervention to children of anxious parents, and a child-focused intervention to children of non-anxious parents, were found to be the most cost-effective approach. [ABSTRACT FROM AUTHOR]

Abstract: In this study, the cost-effectiveness of three indicated anxiety prevention strategies was examined from a societal perspective. Children (aged 8–12) were recruited via primary schools, selecting children scoring as high-anxious on an anxiety screening questionnaire. Participating children and their parents were randomized to a child – a parent-focused, or non-intervention group. All groups completed a diagnostic interview and standardized cost-diaries at pretest, and 1- and 2-year follow-up. Incremental cost-effectiveness ratios per ‘ADIS improved’ child (based on diagnostic information) were calculated and cost-effectiveness acceptability curves and frontiers were plotted. The base-case and most secondary analyses showed it would be cost-effective to offer high-anxious children an intervention, and the parent-focused intervention to be the optimal strategy at lower monetary threshold values than the child-focused intervention and when parents were anxious. The child-focused intervention was dominant when analyses were performed from a healthcare perspective, for boys, and for children of grades 7–8 of primary school. [Copyright &y& Elsevier]

Background: Nowadays, an increasing number of discrete-choice experiments (DCEs) incorporate cost as an attribute. However, the inclusion of a cost attribute, particularly within collectively funded healthcare systems, can be challenging because health services or goods are generally not traded in a market situation and individuals are not used to paying for a service or a good at the point of consumption. Objective: To examine whether the inclusion of a cost attribute in a DCE results in different preferences regarding a surgical treatment for primary basal cell carcinoma (BCC) compared with a DCE without a cost attribute. Methods: A randomized study was performed in which the impact of a cost attribute on the general public's preferences for a surgical treatment (Mohs micrographic surgery [MMS] or standard excision [SE]) to remove BCC was examined. This was done by comparing the outcomes of two DCEs, one with a cost attribute (DCE_cost) and one without (DCE_nocost). Six attributes (recurrence, re-excision, travel time, surgical time, waiting time for surgical results, costs) and their levels were selected, based on results of a clinical trial, a cost-effectiveness study, a review and a focus group of patients who had recently received treatment for BCC. Outcomes of both DCEs were compared in terms of theoretical validity, relative importance of the attributes and the rank order of preferences. Results: A total of 615 respondents (n = 303 for DCE_nocost; n = 312 for DCE_cost) were interviewed by telephone. This gave an overall response rate of 38%. Respondents in DCE_nocost preferred a surgical treatment with a lower probability of recurrence, lower surgery time, lower waiting time and no risk for a re-excision. Respondents in DCE_cost showed the same preferences, but also preferred a treatment with less travel time and lower costs. Overall, respondents in both DCEs showed the same preference for a surgical treatment: MMS was preferred over SE. Conclusion: Results suggest that, in this population, the inclusion of a cost attribute in a DCE leads to the same preference regarding a surgical treatment to remove BCC as a DCE without a cost attribute. However, further research in different settings is needed to confirm these findings. [ABSTRACT FROM AUTHOR]

Background. Short stay (admission, surgery, and discharge the same day or within 24 hours) following breast cancer surgery is part of an established care protocol but as yet not well implemented in Europe. Alongside a before-after multi-centre implementation study, an economic evaluation was performed exploring the cost-effectiveness of a short stay programme (SSP) versus care as usual (CAU). Material and methods. In the implementation study, 324 patients were included. In the economic evaluation a societal perspective was applied with a six week time horizon. Cost data were obtained from Case Record Forms and cost diaries. Effectiveness was assessed by calculating Quality Adjusted Life Years (QALYs), using the EuroQol-5D. Cost-effectiveness was expressed as the incremental costs per QALY. Results. Mean societal costs decreased by €955,- (95% CI € - 2104,- to €157,-) for patients in SSP (n=127) compared with CAU (n=135). Mean healthcare costs differed €883,- (95% CI € - 1560,- to €870,-) in favour of SSP. The incremental cost-effectiveness ratio could not be calculated due to similar effectiveness for both groups, i.e. the difference in QALYs was zero. The cost-effectiveness acceptability curves showed that the probability that SSP was more cost-effective than CAU was over 90% in the base-case analysis. Discussion. A short stay programme as implemented is cost-effective compared with care as usual. In achieving good and more efficient quality of care, larger scale implementation is warranted. [ABSTRACT FROM AUTHOR]

Background: Preeclampsia and HELLP syndrome may have serious consequences for both mother and fetus. Women who have suffered from preeclampsia or the HELLP syndrome, have an increased risk of developing preeclampsia in a subsequent pregnancy. However, most women will develop no or only minor complications. In this study, we intend to determine cost-effectiveness of recurrence risk guided care versus care as usual in pregnant women with a history of early-onset preeclampsia. Methods/design: We developed a prediction model to estimate the individual risk of recurrence of early-onset preeclampsia and the HELLP syndrome. In a before-after study, pregnant women with preeclampsia or HELLP syndrome in their previous pregnancy receiving care as usual (before introduction of the prediction model) will be compared with women receiving recurrence risk guided care (after introduction of the prediction model). Eligible and pregnant women will be recruited at six university hospitals and seven large non-university tertiary referral hospitals in the Netherlands. The primary outcome measure is the recurrence of early-onset preeclampsia or HELLP syndrome in women allocated to the regular monitoring group. For the economic evaluation, a modelling approach will be used. Costs and effects of recurrence risk guided care with those of care as usual will be compared by means of a decision model. Two incremental cost-effectiveness ratios will be calculated: 1) cost per Quality Adjusted Life Year (mother unit of analysis) and 2) cost per live born child (child unit of analysis). Discussion: This is, to our knowledge, the first study that evaluates prospectively the efficacy of a multivariable prediction rule for recurrent hypertensive disease in pregnancy. Results of this study could either be integrated into the current guideline on Hypertensive Disorders in Pregnancy, or be used to develop a new guideline. [ABSTRACT FROM AUTHOR]

The objective of this study was to investigate the cost-effectiveness of family cognitive-behavioral therapy (CBT) compared with individual CBT in children with anxiety disorders. Clinically anxious children (aged 8-18 years) referred for treatment were randomly assigned to family or individual CBT and were assessed pre-treatment, post treatment, and at 3 months and 1 year after treatment. Cost effectiveness ratios were calculated expressing the incremental costs per anxietyfree child and the incremental costs per Quality Adjusted Life Year (QALY) for the referred child. Neither societal costs nor effectiveness were significantly different between individual and family CBT. However, the point estimates of the cost-effectiveness ratios resulted in dominance for individual CBT, indicating that individual CBT is more effective and less costly than family CBT. These results were confirmed by bootstrap analyses and cost-effectiveness acceptability curves. Several secondary and sensitivity analyses showed that the results were robust. It can be concluded that family CBT is not a cost-effective treatment for clinically anxious children, compared with individual CBT. [ABSTRACT FROM AUTHOR]

Background: Schema-focused therapy (SFT) and transference-focused psychotherapy (TFP) for borderline personality disorder were recently compared in a randomised multicentre trial.Aims: To assess the societal cost-effectiveness of SFT v. TFP in treating borderline personality disorder.Method: Costs were assessed by interview. Health-related quality of life was measured using EQ-5D. Outcomes were costs per recovered patient (recovery assessed with the Borderline Personality Disorder Severity Index) and costs per quality-adjusted life-year (QALY).Results: Mean 4-year bootstrapped costs were euro37 826 for SFT and euro46 795 for TFP (95% uncertainty interval for difference -21 775 to 3546); QALYs were 2.15 for SFT and 2.27 for TFP (95% UI -0.51 to 0.28). The percentages of patients who recovered were 52% and 29% respectively. The SFT intervention was less costly and more effective than TFP (dominant), for recovery; it saved euro90 457 for one QALY loss.Conclusions: Despite the initial slight disadvantage in QALYs, there is a high probability that compared with TFP, SFT is a cost-effective treatment for borderline personality disorder. [ABSTRACT FROM AUTHOR]

Background: Non-adherence to antihypertensive drugs is high, and the economic consequences of non-adherence may be substantial. The Medication Events Monitoring System (MEMS), which is a method to improve adherence, has been shown to be a useful tool for the management of adherence problems.Objective: To assess the cost effectiveness of the MEMS compared with usual care in a population of hypertensive patients with poor adherence. The MEMS programme consisted of provision of containers fitted with electronic caps together with adherence training if indicated.Methods: In a randomised controlled trial, 164 hypertensive patients in the experimental strategy and 89 patients in the usual care strategy were followed for 5 months. Patients who had a systolic blood pressure (SBP) > or = 160 mm Hg and/or diastolic BP (DBP) > or = 95 mm Hg despite the use of antihypertensive drugs were eligible. Patients were recruited by a GP, and treatment took place in general practice. In the experimental strategy, electronic monitoring of the intake of antihypertensive drugs was introduced without change of medication. Unsatisfactory adherence was defined as < 85% of days with the number of doses taken as prescribed. In the usual care strategy, antihypertensive treatment was intensified by the addition or change of antihypertensive drugs, if necessary, without provision of an electronic monitor. Outcome parameters included the proportion of patients with normalised blood pressure (NBP) at 5 months and QALYs. Costs were quantified from the healthcare and societal perspective. Non-parametric bootstrap simulations were performed to quantify the uncertainty around the mean estimates and cost-effectiveness acceptability curves were presented. In addition, a number of univariate sensitivity analyses were performed on deterministic variables.Results: At 5 months, 3.1% (95% UI [uncertainty interval] -9.7%, +15.8%) more patients had NBP, and 0.003 (95% UI -0.005, +0.010) more QALYs were generated in the experimental strategy. A statistically significant lower percentage of patients had a dose escalation in the experimental strategy. Irrespective of the ceiling ratio for cost effectiveness, the cost-effectiveness probability was between 75% and 80% for the analysis from the healthcare perspective using proportion of patients with NBP as the outcome parameter. For the analysis from the societal perspective using QALYs as the outcome parameter, this probability was between 45% and 51%.Conclusion: For a time horizon of 5 months, a difference in both cost and effect could not be detected between an adherence-improving programme compared with usual care for hypertensive patients. The probability that the adherence-improving programme is cost effective is at best moderate. Moreover, the cost-effectiveness result is surrounded with considerable uncertainty and large-scale implementation warrants additional research into the economic consequences of this intervention. Patients may benefit from the use of a MEMS monitor in situations where BP targets are not reached because of suspected non-adherence and both patient and GP are reluctant to increase the dose or number of antihypertensive drugs. [ABSTRACT FROM AUTHOR]

Currently, there is no consensus regarding the best treatment option in recurrent haemorrhoidal disease (HD), due to a lack of solid evidence. The Napoleon trial aims to provide high-level evidence on the comparative effectiveness and cost-effectiveness of repeat rubber band ligation (RBL) versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent HD. This is a multicentre randomized controlled trial. Patients with recurrent HD grade II and III, ≥18 years of age and who had at least two RBL treatments in the last three years are eligible for inclusion. Exclusion criteria include previous rectal or anal surgery, rectal radiation, pre-existing sphincter injury or otherwise pathologies of the colon and rectum, pregnancy, presence of hypercoagulability disorders, and medically unfit for surgery (ASA > III). Between June 2020 and May 2022, 558 patients will be randomized to receive either: (1) RBL, (2) sutured mucopexy, or (3) haemorrhoidectomy. The primary outcomes are recurrence after 52 weeks and patient-reported symptoms measured by the PROM-HISS. Secondary outcomes are impact on daily life, treatment satisfaction, early and late complication rates, health-related quality of life, costs and cost-effectiveness, and budget impact. Cost-effectiveness will be expressed in societal costs per Quality Adjusted Life Year (QALY) (based on EQ-5D-5L), and healthcare costs per recurrence avoided. The best treatment option for recurrent HD remains unknown. The comparison of three generally accepted treatment strategies in a randomized controlled trial will provide high-level evidence on the most (cost-) effective treatment. ClinicalTrials.gov identifier: NCT04101773 • There is a lack of consensus on the treatment of recurrent haemorrhoidal disease • A randomized controlled trial is the gold standard for effectiveness research • This study aims to provide high-level evidence on the comparative (cost)effectiveness of three generally accepted treatments. [ABSTRACT FROM AUTHOR]

Background: Obstetric health care relies on an adequate antepartum risk selection. Most guidelines used for risk stratification, however, do not assess absolute risks. In 2017, a prediction tool was implemented in a Dutch region. This tool combines first trimester prediction models with obstetric care paths tailored to the individual risk profile, enabling risk-based care.Objective: To assess impact and cost-effectiveness of risk-based care compared to care-as-usual in a general population.Methods: A before-after study was conducted using 2 multicenter prospective cohorts. The first cohort (2013-2015) received care-as-usual; the second cohort (2017-2018) received risk-based care. Health outcomes were (1) a composite of adverse perinatal outcomes and (2) maternal quality-adjusted life-years. Costs were estimated using a health care perspective from conception to 6 weeks after the due date. Mean costs per woman, cost differences between the 2 groups, and incremental cost effectiveness ratios were calculated. Sensitivity analyses were performed to evaluate the robustness of the findings.Results: In total 3425 women were included. In nulliparous women there was a significant reduction of perinatal adverse outcomes among the risk-based care group (adjusted odds ratio, 0.56; 95% confidence interval, 0.32-0.94), but not in multiparous women. Mean costs per pregnant woman were significantly lower for risk-based care (mean difference, -€2766; 95% confidence interval, -€3700 to -€1825). No differences in maternal quality of life, adjusted for baseline health, were observed.Conclusion: In the Netherlands, risk-based care in nulliparous women was associated with improved perinatal outcomes as compared to care-as-usual. Furthermore, risk-based care was cost-effective compared to care-as-usual and resulted in lower health care costs. [ABSTRACT FROM AUTHOR]

In an ageing population, efficiency improvements are required to assure future accessibility of cataract care. We aim to address remaining knowledge gaps by evaluating the safety, effectiveness, and cost-effectiveness of immediate sequential bilateral cataract surgery (ISBCS) versus delayed sequential bilateral cataract surgery (DSBCS). We hypothesised that ISBCS is non-inferior to DSBCS, regarding safety and effectiveness, and being superior in cost-effectiveness. We did a multicentre, non-inferiority, randomised controlled trial, which included participants from ten Dutch hospitals. Eligible participants were 18 years or older, underwent expected uncomplicated surgery, and had no increased risk of endophthalmitis or refractive surprise. Participants were randomly assigned (1:1) to either the ISBCS (intervention) group or DSBCS (conventional procedure) group, using a web-based system stratified by centre and axial length. Participants and outcome assessors were not masked to the treatment groups because of the nature of the intervention. The primary outcome was the proportion of second eyes with a target refractive outcome of 1·0 dioptre (D) or less 4 weeks postoperatively, with a non-inferiority margin of –5% for ISBCS versus DSBCS. For the trial-based economic evaluation, the primary endpoint was the incremental societal costs per quality-adjusted life-year. All analyses were done by a modified intention-to-treat principle. Costs were calculated by multiplying volumes of resource use with unit cost prices and converted to 2020 Euros (€) and US$. This study was registered with ClinicalTrials.gov, number NCT03400124 , and is now closed for recruitment. Between Sept 4, 2018, and July 10, 2020, a total of 865 patients were randomly assigned to either the ISBCS group (427 [49%] patients; 854 eyes) or DSBCS group (438 [51%] patients; 876 eyes). In the modified intention-to-treat analysis, the proportion of second eyes with a target refraction of 1·0 D or less was 97% (404 of 417 patients) in the ISBCS group versus 98% (407 of 417) in the DSBCS group. The percentage difference was –1% (90% CI –3 to 1; p=0·526), thereby establishing non-inferiority for ISBCS compared with DSBCS. Endophthalmitis was not observed or reported in either group. Adverse events were comparable between groups, with only a significant difference in disturbing anisometropia (p=0·0001). Societal costs were €403 (US$507) lower with ISBCS than with DSBCS. The cost-effectiveness probability of ISBCS versus DSBCS was 100% across the willingness-to-pay range of €2500–80 000 (US$3145–100 629) per quality-adjusted life-year. Our results showed non-inferiority of ISBCS versus DSBCS regarding effectiveness outcomes, comparable safety, and superior cost-effectiveness of ISBCS. National cost savings could amount to €27·4 million (US$34·5 million) annually, advocating for ISBCS if strict inclusion criteria are applied. Research grant from The Netherlands Organization for Health Research and Development (ZonMw) and Dutch Ophthalmological Society. [ABSTRACT FROM AUTHOR]

Objectives: Our main objective was to compare willingness to accept (WTA) and willingness to pay (WTP) in a discrete choice experiment on hearing aid provision. Additionally, income effect and endowment effect were explored as possible explanations for the disparity between WTA and WTP, and the impact of using a WTA and/or WTP format to elicit monetary valuations on the net benefit of the new organization of hearing aid provision was examined. Methods: Choice sets were based on five attributes: performer of the initial assessment; accuracy of the initial assessment; duration of the pathway; follow-up at the ear, nose, and throat specialist; and costs. Persons with hearing complaints randomly received a WTP (costs defined as extra payment) or WTA (costs defined as discount) version of the experiment. In the versions, except for the cost attribute, all choice sets were equal. Results: The cost coefficient was statistically significantly higher in the WTP format. Marginal WTA was statistically significantly higher than marginal WTP for the attributes accuracy and follow-up. Disparity was higher in the high educational (as proxy for income) group. We did not find proof of an experience endowment effect. Implementing the new intervention would only be recommended when using WTP. Conclusions: WTA exceeds WTP, also in a discrete choice experiment. As this affects monetary valuations, more research on when to use a payment or a discount in the cost attribute is needed before discrete choice results can be used in cost-benefit analyses. [ABSTRACT FROM AUTHOR]

The Risk of Malignancy Index (RMI) is commonly used to diagnose adnexal masses. The aim of the present study was to determine the cost-effectiveness of the RMI compared with subjective assessment (SA) by an expert and the following novel ultrasound models: - Simple rules (SR) added by SA (SR + SA); - SR with inconclusive results diagnosed as malignant (SR + Mal); - Logistic Regression model 2 (LR2); and - Assessment of Different NEoplasias in the adneXa (ADNEX) model. Cost-effectiveness and budget impact analyses were performed from a societal perspective. A decision tree was constructed, and short-term costs and effects were examined in women with adnexal masses. Sensitivity, specificity and the costs of diagnostic strategies were incorporated. Incremental cost-effectiveness ratios were expressed as costs/additional percentage of correctly diagnosed patients. Probabilistic and deterministic sensitivity analyses were performed. Effectiveness was highest for SA (90.7% [95% confidence interval = 77.3–100]), with a cost saving of 5.0% (−€398 per patient [−€1403 to 549]) compared with the RMI. The costs of SR + SA were the lowest (€7180 [6072–8436]), resulting in a cost saving of 9.0% (−€709 per patient [−€1628 to 236]) compared with the RMI, with an effectiveness of 89.6% (75.8–100). SR + SA showed the highest probability of being the most cost-effective when willingness-to-pay was <€350 per additional percentage of correctly diagnosed patients. The RMI had low cost-effectiveness probabilities (<3%) and was inferior to SA, SR + SA and LR2. Budget impact in the Netherlands compared with that of the RMI varied between a cost saving of €4.67 million for SR + SA and additional costs of €3.83 million when implementing ADNEX (cut-off: 10%). The results were robust when tested in sensitivity analyses. Although SA is the best strategy in terms of diagnostic accuracy, SR + SA might be preferred from a cost-effectiveness perspective. [ABSTRACT FROM AUTHOR]

Current guidelines for economic evaluations do not provide specific recommendations for the evaluation of school-based lifestyle interventions. This study examined and discussed the key aspects in the design of economic evaluations on school-based interventions targeting weight-related behaviours among 4-12 year olds. The PubMed and CRD databases (NHS EED) were searched. Grey literature was identified from reference lists and websites of relevant organizations. Full economic evaluations on school-based interventions targeting physical activity, sedentariness, or diet were selected. Key aspects included the objective, audience, intervention, comparator, population, type of analysis, perspective, costs, outcomes, and time horizon. Information was also extracted on measuring and valuing costs and outcomes, linking and extrapolating outcomes, and the maintenance of intervention effects. The 23 included studies reported on cost-effectiveness (CEAs) (N = 12), cost-utility (CUAs) (N = 9), social cost benefit (SCBA) (N = 2), and social return on investment (SROI) (N = 1) analysis. The usual practice comparator was generally not clearly defined. The SROI analysis was the single study that included outcomes in other persons than the child. Healthcare costs (N = 14), productivity costs (N = 4), and costs to the household (N = 3), or education (N = 2) sector were examined. The outcome in trial-based CEAs consisted of a variety of weight-related measures. Seven distinctive models were used to extrapolate health and/or productivity costs. To enhance the usefulness of economic evaluations on school-based lifestyle interventions in allocating public health budgets, transparent reporting on key aspects, broadening the scope of economic evaluations, and standardizing the measurement, valuation, and extrapolation of costs and outcomes should be improved. This study was conducted in Maastricht, the Netherlands. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate cost-effectiveness of penetrating keratoplasty (PK), femtosecond laser-assisted Descemet stripping endothelial keratoplasty (FS-DSEK), and Descemet stripping automated endothelial keratoplasty (DSAEK). Design: Cost-effectiveness analysis based on data from a randomized multicenter clinical trial and a noncomparative prospective study. Methods: Data of 118 patients with corneal endothelial dysfunction were analyzed in the economic evaluation. Forty patients were included in the PK group, 36 in the FS-DSEK group, and 42 in the DSAEK group. The primary incremental cost-effectiveness ratio (ICER) was the incremental costs per clinically improved patient, defined as a patient with a combined effectiveness of both a clinically improved BSCVA (defined as an improvement of at least 2 lines) and a clinically acceptable refractive astigmatism (defined as less than or equal to 3.0 diopters). Analysis was based on a 1-year follow-up period after transplantation. Results: The percentage of treated patients who met the combined effectiveness measures was 52% for DSAEK, 44% for PK, and 43% for FS-DSEK. Mean total costs per patient were €6674 (US$7942), €12 443 (US$14 807), and €7072 (US$8416) in the PK group, FS-DSEK group, and DSAEK group, respectively. FS-DSEK was less effective and more costly compared to both DSAEK and PK. DSAEK was more costly but also more effective compared to PK, resulting in incremental costs of €4975 (US$5920) per additional clinically improved patient. Conclusions: The results of this study show that FS-DSEK was not cost-effective compared to PK and DSAEK. DSAEK, on the other hand, was more costly but also more effective compared to PK. Including societal costs, a longer follow-up period and preparation of the lamellar transplant buttons in a national cornea bank could improve the cost-effectiveness of DSAEK. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the cost effectiveness of deep anterior lamellar keratoplasty (DALK) versus penetrating keratoplasty (PK) in The Netherlands. Design: Cost-effectiveness analysis alongside a randomized, multicenter clinical trial. Methods: Fifty-three patients with corneal stromal pathologic features not affecting the endothelium were included with 28 patients in the DALK group and 25 in the PK group. Quality of life was measured before surgery and 3, 6, and 12 months after surgery. The main outcome measures were incremental cost-effectiveness ratios per clinically improved patient on the 25-item National Eye Institute Visual Functioning Questionnaire and per patient with endothelial cell loss of maximally 20% within the first year. Results: Mean total bootstrapped costs per patient were €7607 (US$10 498) in the DALK group and €6552 (US$9042) in the PK group. The incremental cost-effectiveness ratios were €9977 (US$13 768) per clinically improved patient on the 25-item National Eye Institute Visual Functioning Questionnaire and €6900 (US$9522) per patient with cell loss of maximally 20%. In patients without perforation of the Descemet membrane, the incremental cost-effectiveness ratio was €5250 (US$7245) per patient. Conclusions: This study shows that DALK is more costly and more effective as compared with PK. Results on the 25-item National Eye Institute Visual Functioning Questionnaire were in favor of DALK, and endothelial cell loss in DALK patients remained stable after 6 months, whereas cell loss in PK patients continued. Furthermore, DALK procedures performed without perforation of the Descemet membrane were more effective. However, because it is unknown what society is willing to pay for an additional improved patient, cost effectiveness of DALK within a limited follow-up period of 12 months is unclear. Cost effectiveness of DALK may improve over time because of lower graft failure. [Copyright &y& Elsevier]

The article examines the surgical technique of breast cancer in ultra short stay. During the process, patients filled out questionnaires on quality of life, quality of care and health-related costs and breast cancer nurses. Cost effectiveness of the ultra short stay programme and of the implementation programme were measured. The implementation strategy was based on outcomes of multidisciplinary monthly study groups within each hospital.