ObjectivesVisual impairment and blindness (VI&B) cause a considerable and increasing economic burden in all high-income countries due to population ageing. Thus, we conducted a review of the literature to better understand all relevant costs associated with VI&B and to develop a multiperspective overview.DesignSystematic review: Two independent reviewers searched the relevant literature and assessed the studies for inclusion and exclusion criteria as well as quality.Eligibility criteria for included studiesInterventional, non-interventional and cost of illness studies, conducted prior to May 2012, investigating direct and indirect costs as well as intangible effects related to visual impairment and blindness were included.MethodsWe followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement approach to identify the relevant studies. A meta-analysis was not performed due to the variability of the reported cost categories and varying definition of visual impairment.ResultsA total of 22 studies were included. Hospitalisation and use of medical services around diagnosis and treatment at the onset of VI&B were the largest contributor to direct medical costs. The mean annual expenses per patient were found to be US$ purchasing power parities (PPP) 12 175–14 029 for moderate visual impairment, US$ PPP 13 154–16 321 for severe visual impairment and US$ PPP 14 882–24 180 for blindness, almost twofold the costs for non-blind patients. Informal care was the major contributor to other direct costs, with the time spent by caregivers increasing from 5.8 h/week (or US$ PPP 263) for persons with vision >20/32 up to 94.1 h/week (or US$ PPP 55 062) for persons with vision ≤20/250. VI&B caused considerable indirect costs due to productivity losses, premature mortality and dead-weight losses.ConclusionsVI&B cause a considerable economic burden for affected persons, their caregivers and society at large, which increases with the degree of visual impairment. This review provides insight into the distribution of costs and the economic impact of VI&B.
Background Women with BRCA1/2 mutations are at high risk to develop breast and ovarian cancer. To support these women to participate in shared decision-making, structured nurse-led decision coaching combined with an evidence-based decision aid may be employed. In preparation of the interprofessional randomized controlled trial to evaluate a decision coaching program to support preventive decisions of healthy female BRCA 1/2 gene mutation carriers (EDCP-BRCA), we adapted and piloted an existing training program for specialized nurses and included elements from an existing physician communication training. Methods The training was adapted according to the six-step-approach for medical curriculum development. The educational design is based on experience- and problem-based learning. Subsequently, we conducted a qualitative pilot study. Nurses were recruited from six German centers for familial breast and ovarian cancer. The acceptability and feasibility were assessed by structured class observations, field notes and participants’ feedback. Data were analyzed using qualitative content analysis. The training was revised according to the results. Due to the COVID-19 pandemic, the patient intervention was adapted as a virtual coaching and a brief additional training for nurses was added. Results The training consists of two modules (2 + 1 day) that teach competences in evidence-based medicine and patient information, (risk) communication and decision coaching. One pilot test was conducted with six nurses of which three were specialized and experienced in patient counselling. A final set of eight main categories was derived from the data: framework conditions; interaction; schedule, transparency of goals, content, methods, materials and practical relevance and feasibility. Overall, the training was feasible and comprehensible. Decision coaching materials were awkward to handle and decision coaching role plays were set too short. Therefore, materials will be sent out in advance and the training was extended. Conclusions Specialized nurses are rarely available and nurse-led counselling is not routinely implemented in the centers of familial breast and ovarian cancer. However, training of less qualified nurses seems feasible. Decision coaching in a virtual format seems to be a promising approach. Further research is needed to evaluate its feasibility, acceptability and effectiveness. Trial registration The main trial is registered under DRKS-ID: DRKS00015527.
Background: Female BRCA mutation carriers have an increased lifetime risk for breast and ovarian cancer compared to the general population. Women who carry this mutation have several options to deal with their cancer risk, such as risk-reducing surgeries or intensified breast cancer screening. Previous research has shown that preferences in this scenario are highly dependent on affected women's personalities and value systems. To support these women in the decision-making process, a structured decision support consisting of decision coaching combined with a decision aid might be helpful. Methods/design: A randomized controlled trial will be conducted in order to compare usual care with structured decision support alongside usual care. The decision support program entails nurse-led decision coaching as well as an evidence-based patient decision aid. Nurses are qualified by a 4-day training program in informed decisionmaking and decision coaching. Six centers for Familial Breast and Ovarian Cancer in Germany will be included in the study, with a planned sample size of 398 women. The primary outcome is the congruence between the preferred and the actual played role in the decision-making process as measured by the Control Preferences Scale. It is hypothesized that the structured decision support will enable women to play the preferred role in the decision-making process. Secondary outcomes include the knowledge and attitudes about preventive options, decisional conflict, depression and anxiety, coping self-efficacy, impact of event, and self-concept. A process evaluation will accompany the study. Discussion: The EDCP-BRCA study is the first study to implement and evaluate decision coaching combined with a decision aid for healthy BRCA mutation carriers worldwide. Trial registration {2a}: DRKS-ID: DRKS00015527. Registered 30 October 2019.
Women who are found to carry a BRCA1/2 pathogenic variant experience psychological distress due to an increased risk of breast and ovarian cancer. They may decide between different preventive options. In this secondary analysis of data collected alongside a larger randomized controlled trial, we are looking at 130 newly found BRCA1/2 pathogenic variant carriers and how their coping self-efficacy immediately after genetic test result disclosure is related to their psychological burden and status of preventive decision making. Participants received the Coping Self-Efficacy Scale, the Hospital Anxiety and Depression Scale, the Impact of Event Scale, the Decisional Conflict Scale, and the Stage of Decision-Making Scale after positive genetic test result disclosure. We found that women with higher coping self-efficacy showed fewer symptoms of anxiety or depression and were less affected by receiving the genetic test result in terms of post-traumatic stress. However, coping self-efficacy had no relationship with any decision-related criteria, such as decisional conflict or stage of decision making. This shows that despite its buffering capacity on psychological burden, possessing coping self-efficacy does not lead to more decisiveness in preference-sensitive decisions.
OBJECTIVES:The use of intravitreal injection of vascular endothelial growth factor inhibitors is an effective treatment for AMD and trials have showed similar clinical effects of bevacizumab and ranibizumab. The aim of this study was to estimate the budget impact for Brazilian Ministry of Health (MoH) recommending ranibizumab instead of bevacizumab for AMD. METHODS: We did a deterministic budget impact analysis, with the MoH perspective, comparing the use of ranibizumab and bevacizumab for wet AMD. The target population was estimated by extrapolating epidemiologic data to the Brazilian population. Data about dosage, administration and fractioning were extracted from literature. Prices were obtained with the Brazilian regulatory agency, applying potential discounting benefits. This analysis did not consider the cost of the fractioning process because it will be assumed by the states and not by the MoH. RESULTS: The considered price of the ranibizumab vial was OBJECTIVES: Psoriasis is a chronic disease that impacts significantly on patients' quality of life (QoL). Biological drugs interfere in the immunologic process that triggers and supports psoriasis and, therefore, prove effective in its treatment. The aim of this study was to perform a cost-utility analysis (CUA) comparing biologic treatments (adalimumab, etanercept, infliximab, and ustekinumab) in Italy. METHODS: A decision tree model previously applied to the UK was adapted for Italy using resource and cost data from the Italian Ministry of Health (Ministero della Salute). Clinical efficacy in the treatment of moderate to severe psoriasis was determined by the Psoriasis Area Criteria and Severity Index (PASI). Relative efficacy of biologic treatments was based on a network meta-analysis of clinical trials. A different level of utility is associated with each level of PASI response. Costs included hospitalization, drug acquisition, administration, and monitoring over a 10-year time horizon. Incremental cost-effectiveness ratios (ICERs) compared with supportive care (no systemic therapy) were expressed as euros/quality-adjusted life year (QALY). One-way sensitivity analyses, where key parameters were changed to alternative plausible values, explored uncertainty in the results. RESULTS: In the base case, adalimumab was found to be the most cost effective compared to supportive care (ICER: €52,583), followed by ustekinumab 90 mg (ICER: €52,846), ustekinumab 45 mg (ICER: €54,997), infliximab (ICER: €56,141), etanercept 50 mg BIW (ICER: €77,611), and etanercept 25 mg BIW (ICER: €78,194). The ICER for ustekinumab 90 mg, ustekinumab 45mg, and infliximab compared to adalimumab were €57,052, €140,445, and €86,794, respectively. Adalimumab remained the most cost-effective over the vast majority of the one-way sensitivity analyses. CONCLUSIONS: The analysis demonstrated that adalimumab is the most costeffective biologic for the treatment of patients affected by moderate to severe psoriasis. OBJECTIVES:Treatment strategies for the prevention of macular oedema (MO) in di...
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