Effectiveness of evidence-based decision aids for women with pathogenic BRCA1 or BRCA2 variants in the german health care context: results from a randomized controlled trial.

BACKGROUND: Women with pathogenic BRCA1 or BRCA2 variants are at high risk for breast and ovarian cancer. Preventive options include risk-reducing breast and ovarian surgeries and intensified breast surveillance. However, individual decision-making is often associated with decisional conflicts. Two evidence-based decision aids have recently been developed for these women (healthy or with unilateral breast cancer) for the German context to support them in their decision-making process. This study evaluated their effectiveness. METHODS: In a randomized controlled study, women (aged 18-70 years) with pathogenic BRCA1 or BRCA2 variants were randomly assigned 1:1 to the intervention (IG, n = 230) or control (CG, n = 220) group. All participants received usual care. After baseline survey (t0), IG participants additionally received the DAs. Follow-up surveys were at three (t1) and six (t2) months. Primary outcome was decisional conflict at t1. Secondary analyses included decision status, decision regret, knowledge on risks and preventive options, self-reported psychological symptoms, acceptability of DAs, and preparation for decision-making. RESULTS: Of 450 women recruited, 417 completed t0, 398 completed t1 and 386 completed t2. Compared to CG, IG participants had lower decisional conflict scores at t1 (p = 0.049) and t2 (p = 0.006) and higher scores for knowledge (p = 0.004), acceptability (p = 0.000), and preparation for decision-making (p < 0.01). CONCLUSIONS: These DAs can help improve key parameters of decision-making in women with pathogenic BRCA1 and BRCA2 variants and, thus, provide a useful add-on to the current counseling and care concept for these women in Germany. TRIAL REGISTRATION: German Clinical Trials Register, DRKS-ID: DRKS00015823, retrospectively registered 14/06/2019.

Methods for assessing guideline adherence for invasive procedures in the care of chronic coronary artery disease: a scoping review.

OBJECTIVES: In the care of coronary artery disease (CAD), evidence questions the adequate application of guidelines for cardiovascular procedures, particularly coronary angiographies (CA) and myocardial revascularisation. This review aims to examine how care providers' guideline adherence for CA and myocardial revascularisation in the care of chronic CAD was assessed in the literature. DESIGN: Scoping review. DATA SOURCES: PubMed and EMBASE were searched through in June 2021 (rerun in September 2022). ELIGIBILITY CRITERIA: We included studies assessing care providers' adherence to evidence-based guidelines for CA or myocardial revascularisation in the care of chronic CAD. Studies had to list the evaluation of guideline adherence as study objective, describe the evaluation methods used and report the underlying guidelines and recommendations. DATA EXTRACTION AND SYNTHESIS: Two independent reviewers used standardised forms to extract study characteristics, methodological aspects such as data sources and variables, definitions of guideline adherence and quantification methods and the extent of guideline adherence. To elucidate the measurement of guideline adherence, the main steps were described. RESULTS: Twelve studies (311 869 participants) were included, which evaluated guideline adherence by (1) defining guideline adherence, (2) specifying the study population, (3) assigning (classes of) recommendations and (4) quantifying adherence. Thereby, primarily secondary data were used. Studies differed in their definitions of guideline adherence, where six studies each considered only recommendation class I/grade A/strong recommendations as adherent or additionally recommendation classes IIa/IIb. Furthermore, some of the studies reported a priori definitions and allocation rules for the assignment of recommendation classes. Guideline adherence results ranged from 10% for percutaneous coronary intervention with prior heart team discussion to 98% for coronary artery bypass grafting. CONCLUSION: Due to remarkable inconsistencies in the assessment, a cautious interpretation of the guideline adherence results is required. Future efforts should endeavour to establish a consistent understanding of the concept of guideline adherence.

Data on Utility in Cost-Utility Analyses of Genetic Screen-and-Treat Strategies for Breast and Ovarian Cancer.

Genetic screen-and-treat strategies for the risk-reduction of breast cancer (BC) and ovarian cancer (OC) are often evaluated by cost-utility analyses (CUAs). This analysis compares data on health preferences (i.e., utility values) in CUAs of targeted genetic testing for BC and OC. Based on utilities applied in fourteen CUAs, data on utility including related assumptions were extracted for the health states: (i) genetic test, (ii) risk-reducing surgeries, (iii) BC/OC and (iv) post cancer. In addition, information about the sources of utility and the impact on the cost-effectiveness was extracted. Utility for CUAs relied on heterogeneous data and assumptions for all health states. The utility values ranged from 0.68 to 0.97 for risk-reducing surgeries, 0.6 to 0.85 for BC and 0.5 to 0.82 for OC. In two out of nine studies, considering the impact of the test result strongly affected the cost-effectiveness ratio. While in general utilities seem not to affect the cost-utility ratio, in future modeling studies the impact of a positive/negative test on utility should be considered mandatory. Women's health preferences, which may have changed as a result of improved oncologic care and genetic counselling, should be re-evaluated.