Methodology of the health economic evaluation of the Feel4Diabetes-study.

BACKGROUND: The clinical and economic burden of type 2 diabetes mellitus on society is rising. Effective and efficient preventive measures may stop the increasing prevalence, given that type 2 diabetes mellitus is mainly a lifestyle-driven disease. The Feel4Diabetes-study aimed to tackle unhealthy lifestyle (unhealthy diet, lack of physical activity, sedentary behaviour, and excess weight) of families with a child in the first grades of elementary school. These schools were located in regions with a relatively low socio-economic status in Belgium, Bulgaria, Finland, Greece, Hungary and Spain. Special attention was paid to families with a high risk of developing type 2 diabetes mellitus. METHODS: The aim of this paper is to describe the detailed methodology of the intervention's cost-effectiveness analysis. Based on the health economic evaluation of the Toybox-study, both a decision analytic part and a Markov model have been designed to assess the long-term (time horizon of 70 year with one-year cycles) intervention's value for money. Data sources used for the calculation of health state incidences, transition probabilities between health states, health state costs, and health state utilities are listed. Intervention-related costs were collected by questionnaires and diaries, and attributed to either all families or high risk families only. CONCLUSIONS: The optimal use of limited resources is pivotal. The future results of the health economic evaluation of the Feel4Diabetes-study will contribute to the efficient use of those resources.

Burden of skin cancer in Belgium and cost-effectiveness of primary prevention by reducing ultraviolet exposure.

Skin cancer (melanoma- and non-melanoma skin cancer) is one of the most rapidly increasing cancers worldwide. This study analysed the current and future economic burden of skin cancer in Belgium and the cost-effectiveness of primary prevention of skin cancer. A retrospective bottom-up cost-of-illness study was performed, together with a Markov model in order to analyse the cost-effectiveness and the budget impact analysis of primary prevention of skin cancer in Belgium. Total prevalence of skin cancer in Belgium was estimated to triple in the next 20years. The total economic burden of skin cancer in 2014 in Belgium was estimated at €106 million, with a cumulative cost of €3 billion in 2034. The majority of this total cost was due to melanoma (65%). Over a period of 50years, both a sensitisation campaign and a total ban on sunbed use would lead to a gain in quality-adjusted life-years and cost-savings. For every euro invested in the campaign, €3.6 would be saved on the long-term for the healthcare payer. Policy makers and clinicians should promote UV protection strategies, as they were estimated to be dominant strategies.

Self-operated endovaginal telemonitoring versus traditional monitoring of ovarian stimulation in assisted reproduction: an RCT.

STUDY QUESTION: Does self-operated endovaginal telemonitoring (SOET) of the ovarian stimulation phase in IVF/ICSI produce similar laboratory, clinical, patient reported and health-economic results as traditional monitoring (non-SOET)? SUMMARY ANSWER: SOET is not inferior to traditional monitoring (non-SOET). WHAT IS KNOWN ALREADY: Monitoring the follicular phase is needed to adapt gonadotrophin dose, detect threatening hyperstimulation and plan HCG administration. Currently, patients pay visits to care providers, entailing transportation costs and productivity loss. It stresses patients, partners, care providers and the environment. Patients living at great distance from centres have more difficult access to treatment. The logistics and stress during the follicular phase of assisted reproduction treatment (ART) is often an impediment for treatment. STUDY DESIGNS, SIZE, DURATION: The study was a non-inferiority RCT between SOET and non-SOET performed between February 2012 and October 2013. Sample size calculations of number of metaphase II (MII) oocytes (the primary outcome): 81 patients were needed in each study arm for sufficient statistical power. Block randomization was used with allocation concealment through electronic files. The first sonogram was requested after 5 days of stimulation, after that mostly every 2 days and with a daily sonograms at the end. PARTICIPANTS/MATERIALS, SETTINGS, METHODS: Inclusion criteria were age <41 years, undergoing ICSI, no poor response and having two ovaries. We used a small laptop with USB connected vaginal probe and developed a specific web site application. Sonographic training was given to all women at the initiation of a treatment attempt at the centre. The website contained demonstration material consisting of still images and video sequences, as well as written instructions regarding the use of the instrument and probe handling. In total, 185 eligible patients were recruited in four centres: 123 were randomized; 121 completed SOET (n = 59) or non-SOET (n = 62), and 62/185 (33%) eligible patients declined participation for various reasons. MAIN RESULTS AND THE ROLE OF CHANCE: Patient characteristics were comparable. The clinical results showed similar conception rates (P = 0.47) and ongoing pregnancy rates (SOET: 15/59 = 25%; non-SOET: 16/62 = 26%) (P = 1.00) were obtained. Similar numbers of follicles >15 mm diameter at oocyte retrieval (OR), ova at OR, MII oocytes, log2 MII oocytes, embryos available at transfer, top quality embryos and embryos frozen were obtained in the two groups, indicating non-inferiority of SOET monitoring. Regarding patient-reported outcomes, a significantly higher contentedness of patient and partner (P < 0.01), a higher feeling of empowerment, discretion and more active partner participation (P < 0.001) as well as a trend towards less stress (P = 0.06) were observed in the S versus the NS group. In the economic analysis, the use of SOET led to reduced productivity loss, lower transportation costs, and lower sonogram and consultation costs (all P < 0.001 but higher personnel cost than NS). LIMITATIONS, REASONS FOR CAUTION: The study was stopped (no further funding) before full sample size was reached. There were also a few cases of unexpected poor response, leading to a wider SD than anticipated in the power calculation. However, although the study was underpowered for these reasons, non-inferiority of SOET versus non-SOET was demonstrated. WIDER IMPLICATIONS OF THE FINDINGS: Home monitoring using SOET may provide a patient-centred alternative to the standard methods. ART sonograms can be made, and then sent to the care provider for analysis at any appropriate time and from anywhere if an internet connection is available. This approach offers several advantages for patients as well as care providers, including similar results to the traditional methods with less logistical stress and potentially bringing care to patients in poor resource settings. STUDY FUNDING/COMPETING INTERESTS: Supported by an IOF (industrial research fund) of Ghent University (full protocol available at iBiTech) and as a demonstration project of Flanders Care (Flemish Government). There are no conflicts of interest to declare. TRIAL REGISTRATION NUMBER: EC/2011/669 (Ghent University Hospital), B670201112232 (Belgian registration) and NCT01781143 (clinical trials number).

Impact of altering the invitation package on screening participation among never-screeners in the Flemish population-based cancer screening programs.

BACKGROUND: The total coverage of both the Flemish breast cancer and cervical screening program remain suboptimal, with approximately 63% for both. Of all the women invited to the breast cancer screening program, 14.1% never underwent any type of breast cancer screening (any type of mammogram, ultrasound, or clinical breast examination). For the cervical cancer screening, this proportion of 'never-screeners' is 12.1%. We conducted two randomized controlled trials to assess whether various communication and presentation styles in the invitation package, were effective at motivating women who had never participated to attend. METHODS: The study population was limited to never-screeners (women who had never participated in the screening program). The RCT embedded in the breast cancer screening consisted of seven intervention arms and one control arm (all of them included a fixed appointment by letter). The RCT embedded in the cervical cancer screening consisted of three intervention arms and two control arms. In both RCTs, several content and style adaptations were made to the invitation letter, information leaflet, and envelope. RESULTS: None of the intervention arms in either the breast cancer screening or the cervical cancer screening had a statistically significant impact on the participation rate compared to 'usual care' (the regular invitation package used in the screening program). CONCLUSION: Sending adapted invitation packages to never-screeners, from the Flemish breast and cervical cancer screening program, does not seem to be effective in increasing the proportion of women screened. Innovative methods are needed to motivate never-screeners to be screened.

Cost-effectiveness and Budget Effect Analysis of a Population-Based Skin Cancer Screening.

IMPORTANCE: Several epidemiological studies show an alarming global increase in incidence of melanoma and nonmelanoma skin cancer. OBJECTIVES: To examine the cost-effectiveness of 2 population-based skin cancer screening methods and to assess their budget effect and the influence on skin cancer epidemiological findings. DESIGN, SETTING, AND PARTICIPANTS: A Markov model with a latent period of 20 years and a time horizon of 50 years was used to analyze the cost-effectiveness (societal perspective) and budget effect (public health care payer perspective) of 2 population-based skin cancer screening programs in Belgium compared with the absence of a screening program. A health economic analysis was based on a clinical trial performed in 2014 in Belgium. In the economic model, the total Belgian population 18 years or older was assumed to have been invited for the screening program. MAIN OUTCOMES AND MEASURES: The influence of the screening program on skin cancer epidemiological findings and the cost per quality-adjusted life-year (QALY) gained, as well as the budget effect, expressed as the net costs for the health care payer over 50 years. RESULTS: All participants (1668 total-body skin examination [TBSE] and 248 lesion-directed screening [LDS]) were screened by a team of 6 dermatologists from March 14 to 18, 2014, for TSBE and April 22 and 25 to 27, 2014, for LDS. Both screening strategies produced a gain in QALYs, resulting in incremental cost-effectiveness ratios of €33 072 (US $35 475) per QALY in men and €18 687 (US $20 044) per QALY in women for TBSE and €34 836 (US $37 365) per QALY in men and €19 470 (US $20 884) per QALY in women for LDS. With a 1-time screening, a 4.0% decrease in the incidence rates of stage III and IV melanoma was predicted at the population level relative to the comparator. The budget effect analysis demonstrated that during 20 years, a 1-time screening would incur a net cost for the health care payer of almost €36 million (US $38.6 million) for TBSE or just over €6 million (US $6.4 million) for LDS (€4.1 [US $4.40] or €0.7 [US $0.80], respectively, per adult). CONCLUSIONS AND RELEVANCE: These results can be interpreted as cost-effective at a willingness-to-pay threshold in Belgium of €35 000 (US $37 541) per QALY gained. Based on these findings, a 1-time TBSE in the general adult population 18 years or older is the most cost-effective strategy and is predicted to result in a reduction of skin cancer mortality over 20 years and 50 years. The cost-effectiveness for skin cancer screening is higher in women than in men.

Total-Body Examination vs Lesion-Directed Skin Cancer Screening.

IMPORTANCE: Skin cancer is the most frequent cancer type. It remains unknown if and how screening programs can be organized in a cost-effective manner. OBJECTIVE: To compare the 2 screening strategies of systematic total-body examination (TBE) and lesion-directed screening (LDS), with a focus on the participation rate, detection rate, anxiety, and cost. DESIGN, SETTING, AND PARTICIPANTS: Population-based cross-sectional screenings by a team of 6 dermatologists were organized in 2 sociodemographically similar regions. The TBE was organized in a community of 9325 inhabitants 18 years and older (Wichelen, East Flanders, Belgium) during a 5-day screening (March 14-18, 2014). The LDS was organized in a sociodemographically comparable community (Nevele, East Flanders, Belgium) of 9484 adult inhabitants during a 4-day screening (April 22 and 25-27, 2014). The first population received a personal invitation for a standard TBE. In the second population, individuals were invited for an LDS if they had a lesion meeting 1 or more of the following criteria: ABCD rule (A, asymmetry; B, borders; C, colors; and D, differential structures), ugly duckling sign, new lesion lasting longer than 4 weeks, or red nonhealing lesions. MAIN OUTCOMES AND MEASURES: In total, 1982 individuals were screened, and 47 skin cancers (2.4%) were histologically confirmed, including 9 melanomas (0.5%), 37 basal cell carcinomas (1.9%), and 1 squamous cell carcinoma or Bowen disease (0.1%). RESULTS: The positive predictive value for all suspicious lesions was 56.6% (47 of 83). The participation rate was 17.9% (1668 of 9325) in the TBE group vs 3.3% (314 of 9484) in the LDS group (P < .01). The skin cancer detection rate per 100 participants did not differ significantly between the 2 groups, with rates of 2.3% (39 of 1668) in the TBE group vs 3.2% (8 of 248) in the LDS group (P = .40). The operational effectiveness per 100 invitees was 0.4% (39 of 9325) in the TBE group vs 0.1% (8 of 9484) in the LDS group (P < .01). In addition, LDS was 5.6 times less time consuming than TBE. Participants in the LDS group had significantly higher baseline anxiety levels compared with participants in the TBE group (3.7 vs 3.3 points on a visual analog scale, P < .01). In screenees without a suspicious lesion, anxiety levels significantly dropped after screening. CONCLUSIONS AND RELEVANCE: Total-body examination yielded a higher absolute number of skin cancers. Lesion-directed screening had a similar detection rate of 3.2% (8 of 248) but was 5.6 times less time consuming. When performed by dermatologists, LDS is an acceptable alternative screening method in health care systems with limited budgets or long waiting lists.

Cost-effectiveness of a helpline for suicide prevention.

We evaluated the cost-effectiveness and budget impact of a suicide helpline in Belgium, consisting of a telephone- and a chat service. An age- and gender-dependent Markov model with a ten-year time horizon and a one-year cycle length was developed, assuming a societal perspective, to predict cumulative costs and quality-adjusted life-years (QALYs) in the helpline users. The model included six transition states: the initial state (at risk), first attempt, re-attempt, follow-up, suicide and death from other causes. Data on the effect of the helpline and costs associated with model states were obtained from the literature. One-way and probabilistic sensitivity analyses were performed to capture uncertainty. In addition, the budget impact of the helpline was analysed. Over ten years, the telephone- as well as the chat service could avoid about 36% of suicides and attempts in this high-risk population. In males, 0.063 QALYs (95% confidence interval, CI 0.030-0.097) and 0.035 QALYs (95%CI -0.026-0.096) were gained by users of the telephone- and chat service respectively. The corresponding values for females were 0.019 QALYs (95%CI -0.015-0.052) and a QALY-neutral result of -0.005 (95%CI -0.071-0.062). There were net societal savings of respectively €2382 (95%CI 1953-2859) and €2282 (95%CI 1855-2758) in male users; €2171 (95%CI 1735-2664) and €2458 (95%CI 1945-3025) in female users. At the population level, an investment of €218,899 saved €1,452,022 for the public health service (national health insurance), mainly due to the telephone service. The analysis predicted that both means of telemedicine for suicide prevention in Flanders are cost-saving, and have a modest effect on QALYs.