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.

Developing quality indicators for cross-sectoral psycho-oncology in Germany: combining the RAND/UCLA appropriateness method with a Delphi technique.

BACKGROUND: Internationally, the need for appropriately structured, high-quality care in psycho-oncology is more and more recognized and quality-oriented care is to be established. Quality indicators are becoming increasingly important for a systematic development and improvement of the quality of care. The aim of this study was to develop a set of quality indicators for a new form of care, a cross-sectoral psycho-oncological care program in the German health care system. METHODS: The widely established RAND/UCLA Appropriateness Method was combined with a modified Delphi technique. A systematic literature review was conducted to identify existing indicators. All identified indicators were evaluated and rated in a two-round Delphi process. Expert panels embedded in the Delphi process assessed the indicators in terms of relevance, data availability and feasibility. An indicator was accepted by consensus if at least 75% of the ratings corresponded to category 4 or 5 on a five-point Likert scale. RESULTS: Of the 88 potential indicators derived from a systematic literature review and other sources, 29 were deemed relevant in the first Delphi round. After the first expert panel, 28 of the dissented indicators were re-rated and added. Of these 57 indicators, 45 were found to be feasible in terms of data availability by the second round of expert panel. In total, 22 indicators were transferred into a quality report, implemented and tested within the care networks for participatory quality improvement. In the second Delphi round, the embedded indicators were tested for their practicability. The final set includes 16 indicators that were operationalized in care practice and rated by the expert panel as relevant, comprehensible, and suitable for care practice. CONCLUSION: The developed set of quality indicators has proven in practical testing to be a valid quality assurance tool for internal and external quality management. The study findings could contribute to traceable high quality in cross-sectoral psycho-oncology by providing a valid and comprehensive set of quality indicators. TRIAL REGISTRATION: "Entwicklung eines Qualitätsmanagementsystems in der integrierten, sektorenübergreifenden Psychoonkologie-AP "Qualitätsmanagement und Versorgungsmanagement" zur Studie "integrierte, sektorenübergreifende Psychoonkologie (isPO)" a sub-project of the "integrierte, sektorenübergreifende Psychoonkologie (isPO)", was registered in the German Clinical Trials Register (DRKS) (DRKS-ID: DRKS00021515) on 3rd September 2020. The main project was registered on 30th October 2018 (DRKS-ID: DRKS00015326).

Potential role of d-chiro-inositol in reducing oxidative stress in the blood of nonobese women with polycystic ovary syndrome.

d-chiro-Inositol (DCI), an isomer of inositol, possesses antioxidative and endothelial protective properties. Possibly due to a deficiency of insulin mediators, polycystic ovary syndrome (PCOS) is often associated with insulin resistance (IR) and hyperinsulinemia, likely responsible for an elevated production of reactive oxygen species. We investigated oxidative-related alterations of inositol in the blood of women with PCOS before and after treatment with DCI. A total of 38 normal-weight PCOS women were investigated before and after DCI administration (500 mg/day for 12 weeks; n = 38) by evaluating serum testosterone, serum androstenedione, fasting serum insulin, fasting serum glucose, and parameters of IR. From the blood, we determined biomarkers of oxidative stress: superoxide anion radicals, hydrogen peroxide, nitric oxide, and the index of lipid peroxidation. The activity of catalase and superoxide dismutase and the reduced glutathione (GSH) content in the hemolysate were also assessed. Data showed that PCOS patients' plasma underwent oxidative stress, as indicated by the higher level of prooxidants and reduced cytosolic GSH content. DCI treatment significantly improved the metabolic parameters. Also, serum values of testosterone were reduced. In conclusion, PCOS patients suffer from a systemic oxidative stress that induces endothelial dysfunction. Treatment with DCI is effective in reducing hormonal, metabolic, and oxidative abnormalities in PCOS patients by improving IR.

A time-driven activity-based costing approach of magnetic resonance-guided high-intensity focused ultrasound for cancer-induced bone pain.

OBJECTIVE: To determine resource consumption and total costs for providing magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) treatment to a patient with cancer-induced bone pain (CIBP). METHODS: We conducted a time-driven activity-based costing (TD-ABC) of MR-HIFU treatments for CIBP from a hospital perspective. A European care-pathway (including a macro-, meso-, and micro-level) was designed to incorporate the care-delivery value chain. Time estimates were obtained from medical records and from prospective direct observations. To calculate the capacity cost rate, data from the controlling department of a German university hospital were allocated to the modules of the care pathway. Best- and worst-case scenarios were calculated by applying lower and upper bounds of time measurements. RESULTS: The macro-level care pathway consisted of eight modules (i.e., outpatient consultations, pretreatment imaging, preparation, optimization, sonication, post-treatment, recovery, and anesthesia). The total cost of an MR-HIFU treatment amounted to €5147 per patient. Best- and worst-case scenarios yielded a total cost of €4092 and to €5876. According to cost categories, costs due to equipment accounted for 41% of total costs, followed by costs with personnel (32%), overhead (16%) and materials (11%). CONCLUSION: MR-HIFU is an emerging noninvasive treatment for alleviating CIBP, with increasing evidence on treatment efficacy. This costing study can support MR-HIFU reimbursement negotiations and facilitate the adoption of MR-HIFU as first-line treatment for CIBP. The present TD-ABC model creates the opportunity of benchmarking the provision of MR-HIFU to bone tumor.Key pointsMagnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) is an emerging noninvasive treatment modality for alleviating cancer-induced bone pain (CIBP).From a hospital perspective, the total cost of MR-HIFU amounted to €5147 per treatment.This time-driven activity-based costing model creates the opportunity of benchmarking the provision of MR-HIFU to bone tumor.

Manifestation of an undifferentiated uterine sarcoma in a 51 years old patient and its prognosis: A case report.

INTRODUCTION: Undifferentiated uterine sarcoma is a rare histological subtype of uterine sarcoma. This study aimed to summarize the clinical and pathological presentation of this case. CASE REPORT: A 51-years-old patient was admitted to the clinic because of severe pain in the lower abdomen, and scanty bleeding from the genitals. Gynecological examination revealed an enlarged uterus. Conventional and Doppler transvaginal sonography detected a tumorously altered uterus with a maximum diameter of 20 cm a tumefaction with unclear borders and a diameter of 10 cm, with hyperechoic and hypoechoic fields within the tumefaction, presenting pathological vascularization and reduced values of the (Pulsatile index  ≤ 1) and (Resistance index  ≤ 0.40). Preoperatively, the chest, abdomen, and pelvis were examined. The patient underwent surgery and total abdominal hysterectomy with bilateral salpingo-oophorectomy, and partial omentectomy, with complete removal of the tumor. A pathohistological diagnosis, of undifferentiated uterine sarcoma, was made by excluding other types of uterine sarcomas. At the control examination after completion of chemotherapy, recurrence was ascertained. CONCLUSION: undifferentiated uterine sarcoma is an aggressive malignant tumor that in most cases shows rapid progression of the disease after complete resection of the tumor, with a poor prognosis.

Measuring customer preferences in the German statutory health insurance.

This paper investigates consumer preferences in the German statutory health insurance market. It further aims to test whether preferences differ by age and health status. Evidence is provided by a discrete choice experiment conducted in 2014 using the six most important attributes in sickness fund competition and ten random generated choice sets per participant. Price is found to be the most important attribute followed by additional benefits, managed care programmes, and distance to nearest branch. Other positive attributes of sickness funds are found to balance out a higher price, which would allow a sickness fund to position itself as high quality. However, significant differences in preferences were found between age and health status group. In particular, compromised health is associated with higher preference for illness-related additional benefits and less distance to the lowest branch, but lower preference for a lower price. Based on these differences, a distinct sickness fund offer could be constructed that would allow passive risk selection.

[Disability Pension and Productivity Loss in Schizophrenia - An Empirical Analysis of the Financial Burden in Germany]. / Erwerbsminderung bei Schizophrenie ­ eine empirische Analyse der Folgelasten.

Objective Quantification of the economic burden for society and the German Statutory Pension Insurance due to early retirement in schizophrenia. Methods Based on empirical data of the German Statutory Pension Insurance, productivity losses were calculated using the human capital approach. Results The total expenditures of the German Statutory Pension Insurance due to pension payments for schizophrenic insurants amounted to €â€Š450 million. Total indirect costs due to morbidity and mortality were estimated at €â€Š2,3 million. Average indirect costs per patient ranged between €â€Š17 000 - 28 000, depending on rates for discounting and inflation. Conclusion Regarding substantial economic consequences, preventive measures and therapeutic procedures should aim to prevent reduction in earning capacity and to promote occupational reintegration of schizophrenic patients.

Price elasticities in the German Statutory Health Insurance market before and after the health care reform of 2009.

This paper investigates the change in price elasticity of health insurance choice in Germany after a reform of health insurance contributions. Using a comprehensive data set of all sickness funds between 2004 and 2013, price elasticities are calculated both before and after the reform for the entire market. The general price elasticity is found to be increased more than 4-fold from -0.81 prior to the reform to -3.53 after the reform. By introducing a new kind of health insurance contribution the reform seemingly increased the price elasticity of insured individuals to a more appropriate level under the given market parameters. However, further unintended consequences of the new contribution scheme were massive losses of market share for the more expensive sickness funds and therefore an undivided focus on pricing as the primary competitive element to the detriment of quality.

Risk factors for the prescription of potentially inappropriate medication (PIM) in the elderly : an analysis of sickness fund routine claims data from Germany.

Elderly people are especially prone to suffer adverse drug reactions (ADR). Main reasons for the higher vulnerability of the elderly to ADR are changes in metabolism as i.e. slower renal clearance and polypharmacie which often results from multimorbidity. To prevent ADR careful prescription with special consideration of these aspects is warranted. To help physicians avoid drugs which are especially likely to cause ADR lists have been developed following the consensus method process. For Germany this list is called the PRISCUS list. It was developed based on a literature review, review of international lists such as the American Beers list, and a consensus process based on a Delphi survey. It contains 83 drugs from 18 classes which are classified as potentially inapropriate medication (PIM). It also lists alternatives for each PIM. If a drug is registered with the PRISCUS list this does not mean automatically that it is contraindicated in the elderly but that special caution should be excercised in prescribing the drug, alternatives should be considered and the patient carefully monitored.Prescription rates for PIMs in Germany in the elderly is pretty much stable at around 23% with only a small decline in the past years. Also, more than 5% of all prescriptions in the elderly are PIM prescriptions. Physicians specially trained in geriatrics tend to prescribe less PIMs compared to other physicians.

Efficacy of a long-term secondary prevention programme following inpatient cardiovascular rehabilitation on risk and health-related quality of life in a low-education cohort: a randomized controlled study.

OBJECTIVE: The aim of this study was to evaluate the efficacy of a long-term secondary prevention programme following inpatient cardiovascular rehabilitation on cardiovascular risk and health-related quality of life in a cohort of middle-aged (≤58 years) coronary artery disease (CAD) patients of low educational level compared to usual care. DESIGN AND METHODS: The study included 600 patients with CAD, with 271 in the intervention group (IG) and 329 in the control group (CG). The average age was nearly 50 years in both groups, nearly 90% were male, and 77% had less than 10 years of school education. No significant differences existed between the groups at baseline. Both groups had a 3-week comprehensive cardiovascular inpatient rehabilitation programme at the beginning, the intervention consisted of one further rehabilitation session in hospital after 6 months and regular telephone reminders over a period of 36 months. Analyses were conducted on an intention-to-treat basis. To evaluate the individual risk level, we used the PROCAM score and intima-media thickness (IMT) was measured at the common carotid artery on both sides following international standards. Health-related quality of life was assessed with the EUROQOL and HADS. RESULTS: Patients in the IG showed better 3-year risk profile outcomes. The PROCAM score increased by 3.0 (IG) and by 3.7 (CG) from the beginning to after 3 years (p > 0.05 intention-to-treat). The average IMT increased by 0.04 mm in the CG and was reduced by 0.03 mm in the IG (p = 0.014 for the difference). The IG had a significant improvement in health-related quality of life. Mortality, myocardial infarction, and stroke were not different although 'other cardiac events' (cardiac surgery or intervention) were significantly lower in the IG than the CG patients (p < 0.05). CONCLUSION: This long-term secondary prevention programme with inpatient rehabilitation at the beginning and telephone reminder for a 3-year period was successful. There were significant differences in health-related quality of life between the IG and CG, despite the relatively positive outcomes in the CG. In this low-education (predominantly male), middle-aged cohort, the positive impact on cardiovascular risk was pronounced in the high-risk subgroup (PROCAM 10-year risk 10-40%).

["All of us actually practice EBM!" - Attitudes of German GPs towards evidence-based medicine and clinical guidelines in daily practice: a focus group study]. / "Wir machen doch eigentlich alle EbM!" - Vorstellungen und Haltungen deutscher Hausärzte zu Evidenzbasierter Medizin und Leitlinien im Praxisalltag: Eine qualitative Studie.

BACKGROUND: Implementation of guidelines in general practice is difficult. Do general practitioners (GPs) reject evidence-based medicine (EBM) in general? Which attitudes do GPs have towards EBM and guidelines, and which value do they attach to EBM in daily routine? METHODS: We conducted a qualitative study using five focus groups with 53 GPs. The study was set in the German federal states of Bavaria, Saxony, North Rhine-Westphalia, Hesse and Hamburg. Participants were selected according to area (rural/urban), region (North/South, East/West) and grade of professionalisation. Focus groups were digitally recorded and fully transcribed. Data were analysed in a multidisciplinary team using qualitative content analysis. RESULTS: Most participants felt positive towards EBM. Lack of feasibility was explicitly mentioned: the participants distinguished between "practised" and "true" EBM. Guidelines are often considered unsuitable for general practice. The GPs felt confident that their treatment of patients was evidence-based. CONCLUSIONS: Compared to older studies, German GPs have an increasingly favourable opinion about EBM. In order to enhance the practical application of EBM and guidelines the attitudes of GPs need to be considered.