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Sabine Ettinger,1 Michal Stanak,1 Piotr Szymański,2 Claudia Wild,1 Romana Tandara Haček,3 Darija Erčević,3 Renata Grenković,3 Gregor Goetz,1 Mirjana Huić3 1Ludwig Boltzmann Institute for Health Technology Assessment, Vienna, Austria; 2Institute of Cardiology, Warsaw, Poland; 3Department for Development, Research, and Health Technology Assessment, Agency for Quality and Accreditation in Health Care and Social Welfare, Zagreb, CroatiaAlthough we clearly outlined our answers in our previous letter,1 we are pleased to clarify further any remaining open issues. There might be diverse views with regard to comparators of the wearable cardioverter defibrillator (WCD). We would like to refer the readers to our previous answer,1 where we explained our rationale for choosing the implantable cardioverter defibrillator as one of the comparators. It was selected based on broad indications stated in the CE mark and after discussions with clinicians. Furthermore, in this case, a change of the comparator, ie, the implantable cardioverter defibrillator, would not have led to a different result or conclusion.View the original paper by Ettinger and colleagues.Two previous letters have been published Sperzel et al Sperzel et al

Sabine Ettinger,1 Michal Stanak,1 Piotr Szymański,2 Claudia Wild,1 Romana Tandara Haček,3 Darija Erčević,3 Renata Grenković,3 Mirjana Huić3 1Ludwig Boltzmann Institute for Health Technology Assessment, Vienna, Austria; 2Institute of Cardiology, Warsaw, Poland; 3Department for Development, Research and Health Technology Assessment, Agency for Quality and Accreditation in Health Care and Social Welfare, Zagreb, Croatia Aim: To summarize the evidence on clinical effectiveness and safety of wearable cardioverter defibrillator (WCD) therapy for primary and secondary prevention of sudden cardiac arrest in patients at risk. Methods: We performed a systematic literature search in databases including MEDLINE via OVID, Embase, the Cochrane Library, and CRD (DARE, NHS-EED, HTA). The evidence obtained was summarized according to GRADE methodology. A health technology assessment (HTA) was conducted using the HTA Core Model® for rapid relative effectiveness assessment. Primary outcomes for the clinical effectiveness domain were all-cause and disease-specific mortality. Outcomes for the safety domain were adverse events (AEs) and serious adverse events (SAEs). A focus group with cardiac disease patients was conducted to evaluate ethical, organizational, patient, social, and legal aspects of the WCD use. Results: No randomized- or non-randomized controlled trials were identified. Non-comparative studies (n=5) reported AEs including skin rash/itching (6%), false alarms (14%), and palpitations/light-headedness/fainting (9%) and discontinuation due to comfort/lifestyle issues (16–22%), and SAEs including inappropriate shocks (0–2%), unsuccessful shocks (0–0.7%), and death (0–0.3%). The focus group results reported that experiencing a sense of security is crucial to patients and that the WCD is not considered an option for weeks or even months due to expected restrictions in living a “normal” life. Conclusion: The WCD appears to be relatively safe for short-to-medium term, but the quality of existing evidence is very low. AEs and SAEs need to be more appropriately reported in order to further evaluate the safety of the device. High-quality comparative evidence and well-described disease groups are required to assess the effectiveness of the WCD and to determine which patient groups may benefit most from the intervention. Keywords: sudden cardiac arrest, ventricular tachycardia, ventricular fibrillation, cardioverter defibrillator, external, wearable, patient involvement

There are several risk prediction models for screen-detected breast cancer but to the best of our knowledge, none for predicting risk from the interval cancer in breast cancer screening. The challenge for developing such a model was that the risk factors for both cancers appear to be similar, but the effects of interval cancer on women's health are more severe due to its higher biological aggressiveness. Our model is based on risk factors identified in the female population in the Republic of Croatia. Anonymized data from 472,395 women who participated in the National Program for Early Detection of Breast Cancer during the first three cycles of the program (October 2006-May 2014) were used. Cancer data from the Breast Cancer Screening Registry were linked by the data linkage method with data from the Cancer Registry of the Republic of Croatia. A total of 789 women with interval cancer and 3,530 women with screen-detected cancer were identified. Multivariate logistic regression in R was used to model the difference between participants with screen-detected cancer and those with interval cancer, using the general linear model (glm) function. The variables used for the analysis were selected using the all subset regression analysis method. The criterion of the least complexity parameter, the Cp-Mallows index, was chosen. Three variables were found to be statistically significant in the model: breast tissue density (p=0.038), hormone replacement therapy (p=0.034), and a first-degree family history of breast cancer (p<0.001). The resulting model has a discriminant accuracy of 0.658 (95% CI 0.602-0.713). Although our model has poorer predictor reliability, its advantage is that it is based on real-world data and that the criteria for interval cancer were strictly followed. It is best suited for use in the Croatian population of women because we have identified the available risk factors for the development of interval cancer in our population, but with knowledge of a specific epidemiological environment, it can be more widely applied. The model can be used to make recommendations for individual screening participants. The variables of breast tissue density and first-degree family history of breast cancer increase the likelihood of interval cancer and indicate an increased risk of detecting interval cancer between mammograms. Consequently, individualized risk screening should be considered (modification of screening interval or additional screening by magnetic resonance or ultrasound). According to the model, hormone replacement therapy is positively related to screen-detected cancer, and participants who use hormone replacement therapy must be medically monitored due to the increased risk of screen-detected cancer. In addition, participants in the screening program who use hormone replacement therapy and have a higher density of breast tissue should be encouraged to have more frequent mammograms.

Aim: To develop pragmatic recommendations for Central and Eastern European (CEE) policymakers about transferability assessment of integrated care models established in higher income European Union (EU) countries., Methods: Draft recommendations were developed based on Horizon 2020-funded SELFIE project deliverables related to 17 promising integrated care models for multimorbid patients throughout Europe, as well as on an online survey among CEE stakeholders on the relevance of implementation barriers. Draft recommendations were discussed at the SELFIE transferability workshop and finalized together with 22 experts from 12 CEE countries., Results: Thirteen transferability recommendations are provided in three areas. Feasibility of local implementation covers the identification and prioritization of implementation barriers and proposals for potential solutions. Performance measurement of potentially transferable models focuses on the selection of models with proven benefits and assurance of performance monitoring. Transferability of financing methods for integrated care explores the relevance of financing methodologies and planning of adequate initial and long-term financing., Conclusions: Implementation of international integrated care models cannot be recommended without evidence on its local feasibility or scientifically sound and locally relevant performance assessment in the country of origin. However, if the original financing method is not transferable to the target region, development of a locally relevant alternative financing method can be considered.