Lore Pil

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 Therapeutic Education to Prevent the Development and Progression of Type 2 Diabetes: Systematic Review

Objective: To update current evidence on the cost-effectiveness (CE) of therapeutic education in prediabetes and type 2 diabetes. Research design and methods: A systematic review of economic evaluations of therapeutic education in prediabetes and type 2 diabetes, based on Randomized Controlled Trials (RCTs) and published in 2002 - 2014. The quality of the clinical evidence was appraised through the Cochrane Collaboration’s tool for assessing risk of bias. Economic studies were evaluated through the Consensus Health Economic Criteria List. The Incremental Cost- Effectiveness Ratios (ICERs) of patient education in prediabetes and type 2 diabetes were compared. Results: Out of 2031 identified publications, eight studies on prediabetes and nine on type 2 diabetes met the inclusion criteria. The level of the underlying clinical evidence was overall high in studies on prediabetes and varied in studies on type 2 diabetes. The mean ICER (95% CI) from the perspective of the healthcare system was €18,000 per QALY (range from dominance to €49,700) in prediabetes and €29,700 (range from €9,100 to €50,300) per QALY in type 2 diabetes. General flaws in the economic evaluations were short time horizons, limited uncertainty analysis and a lack of transparency in the modeling methods. Conclusions: The number of economic evaluations of patient education in prediabetes and type 2 diabetes has been growing in the past years. Our review compares the health economic evidence on therapeutic education for both conditions. The findings suggest that offering therapeutic education already in prediabetes stage may be a better value for money than postponing it till after the diagnosis. More robust methodologies in health economic evaluations are essential in further evidence generation.

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.

Establishing a method to estimate the cost-effectiveness of a kindergarten-based, family-involved intervention to prevent obesity in early childhood. The ToyBox-study

Overweight and obesity in children are recognized as a major health problem. The ToyBox‐intervention was developed with the aim of preventing obesity in pre‐schoolers. Because it is increasingly important to inform policy makers not only on the effects of prevention interventions, but also on their costs and cost‐effectiveness, our purpose was to establish a method to estimate the cost‐effectiveness of the ToyBox‐intervention. In order to estimate the long‐term impact of the ToyBox‐intervention on health and societal costs, extrapolations of the intervention effect will be conducted to predict childrens weight status (based on the body mass index) at adult age. Effects of the adult weight status on the prevalence of obesity‐related complications will be modelled through a Markov model, with a total time horizon of 70 years and a cycle length of 1 year. The model will be conducted in six European countries participating in the ToyBox‐intervention, based on country‐specific economic and epidemiological data. This study describes the methodological rationale and implementation of an analytic model to examine the cost‐effectiveness of the ToyBox‐intervention for six European countries, in order to inform decision‐makers on the value for money of this intervention in the prevention of obesity in pre‐schoolers.

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).

Cost-effectiveness and budget impact analysis of a population-based screening program for colorectal cancer

BACKGROUND Colorectal cancer (CRC) is one of the leading causes of cancer mortality in Belgium. In Flanders (Belgium), a population-based screening program with a biennial immunochemical faecal occult blood test (iFOBT) in women and men aged 56-74 has been organised since 2013. This study assessed the cost-effectiveness and budget impact of the colorectal population-based screening program in Flanders (Belgium). METHODS A health economic model was conducted, consisting of a decision tree simulating the screening process and a Markov model, with a time horizon of 20years, simulating natural progression. Predicted mortality and incidence, total costs, and quality-adjusted life-years (QALYs) with and without the screening program were calculated in order to determine the incremental cost-effectiveness ratio of CRC screening. Deterministic and probabilistic sensitivity analyses were conducted, taking into account uncertainty of the model parameters. RESULTS Mortality and incidence were predicted to decrease over 20years. The colorectal screening program in Flanders is found to be cost-effective with an ICER of 1681/QALY (95% CI -1317 to 6601) in males and €4,484/QALY (95% CI -3254 to 18,163). The probability of being cost-effective given a threshold of €35,000/QALY was 100% and 97.3%, respectively. The budget impact analysis showed the extra cost for the health care payer to be limited. CONCLUSION This health economic analysis has shown that despite the possible adverse effects of screening and the extra costs for the health care payer and the patient, the population-based screening program for CRC in Flanders is cost-effective and should therefore be maintained.