Decision Coaching for Healthy Women With BRCA1/2 Pathogenic Variants­Findings of the Randomized Controlled EDCP-BRCA Trial.

BACKGROUND: Women with BRCA1/2 pathogenic variants (PVs) have a choice of preventive options. To help these women decide for themselves, we developed and implemented a decision coaching (DC) program and evaluated it for congruence between the participants' desired and actual roles in decision-making. METHODS: Healthy BRCA1/2 PV carriers (from 25 to 60 years of age) were recruited at six centers in Germany. Those returning baseline T1-questionnaires were randomly assigned to the intervention group (IG) or the control group (CG). The IG attended a nurse-led DC program. The primary outcome was congruence between the participants' desired and actual roles in decision-making. The secondary outcomes included an active role, satisfaction, decisional conflict, and knowledge. Follow-up data were obtained by questionnaire at 12 weeks (T2) and 6 months (T3). RESULTS: Of the 413 women who were recruited, 389 returned baseline T1 questionnaires. At T2, the IG and CG groups did not differ significantly in congruence between their desired and actual roles in decision-making (0.12 [95% confidence interval -0.03; 0.28], p=0.128), with a slightly higher congruence in the CG. Women in both groups were more active at T2 than their stated preference at T1, with a notably higher percentage in the IG (IG: 40%, CG: 24.4%; [-25.1; -6.1]). IG participants were more satisfied with the role that they had assumed and had less decisional conflict and greater knowledge. CONCLUSION: These findings imply that this DC program can help women with BRCA1/2 PVs participate actively in decision-making with regard to preventive measures.

Health economic evaluation of blended collaborative care for older multimorbid heart failure patients: study protocol.

BACKGROUND: Integrated care, in particular the 'Blended Collaborative Care (BCC)' strategy, may have the potential to improve health-related quality of life (HRQoL) in multimorbid patients with heart failure (HF) and psychosocial burden at no or low additional cost. The ESCAPE trial is a randomised controlled trial for the evaluation of a BCC approach in five European countries. For the economic evaluation of alongside this trial, the four main objectives were: (i) to document the costs of delivering the intervention, (ii) to assess the running costs across study sites, (iii) to evaluate short-term cost-effectiveness and cost-utility compared to providers' usual care, and (iv) to examine the budgetary implications. METHODS: The trial-based economic analyses will include cross-country cost-effectiveness and cost-utility assessments from a payer perspective. The cost-utility analysis will calculate quality-adjusted life years (QALYs) using the EQ-5D-5L and national value sets. Cost-effectiveness will include the cost per hospital admission avoided and the cost per depression-free days (DFD). Resource use will be measured from different sources, including electronic medical health records, standardised questionnaires, patient receipts and a care manager survey. Uncertainty will be addressed using bootstrapping. DISCUSSION: The various methods and approaches used for data acquisition should provide insights into the potential benefits and cost-effectiveness of a BCC intervention. Providing the economic evaluation of ESCAPE will contribute to a country-based structural and organisational planning of BCC (e.g., the number of patients that may benefit, how many care managers are needed). Improved care is expected to enhance health-related quality of life at little or no extra cost. TRIAL REGISTRATION: The study follows CHEERS2022 and is registered at the German Clinical Trials Register (DRKS00025120).

Predictors of knowledge and knowledge gain after decision aid use among women with BRCA1/2 pathogenic variants.

OBJECTIVE: To identify factors contributing to baseline knowledge in women with BRCA1/2 pathogenic variants (PVs) and knowledge gain after decision aid (DA) use. METHODS: Women with PVs in BRCA1 or BRCA2 genes were randomly assigned to an intervention group (IG) receiving DAs or a control group (CG). Of the total sample, 417 completed the baseline survey and were included in this analysis. Two multiple regression analyses were conducted: baseline data on socio-demographic, medical, decision-related and psychological variables were used to identify predictors for (1) baseline knowledge within the total group and (2) knowledge gain within the IG after DA use three months post study inclusion. RESULTS: At baseline, higher education status, no breast cancer history, and lower decisional conflict related to higher knowledge within the total group. After DA use within the IG, higher baseline scores for decisional conflict predicted higher knowledge gain, and higher baseline scores for depression and intrusion predicted lower knowledge gain. CONCLUSIONS: This study identified predictors of baseline knowledge and knowledge gain after DA use in women with BRCA1/2 PVs. PRACTICE IMPLICATIONS: Awareness of facilitating and hindering factors on these women's knowledge can improve understanding of their health literacy and enable further targeted support interventions.

Health economic consequences of optimal vs. observed guideline adherence of coronary angiography in patients with suspected obstructive stable coronary artery in Germany: a microsimulation model.

AIMS: While the number of patients with stable coronary artery disease (SCAD) is similar across European countries, Germany has the highest per capita volume of coronary angiographies (CA). This study evaluated the health economic consequences of guideline-non-adherent use of CA in patients with SCAD. METHODS AND RESULTS: As part of the ENLIGHT-KHK trial, a prospective observational study, this microsimulation model compared the number of major adverse cardiac events (MACE) and the costs of real-world use of CA with those of (assumed) complete guideline-adherent use (according to the German National Disease Management Guideline 2019). The model considered non-invasive testing, CA, revascularization, MACE (30 days after CA), and medical costs. Model inputs were obtained from the ENLIGHT-KHK trial (i.e. patients' records, a patient questionnaire, and claims data). Incremental cost-effectiveness ratios were calculated by comparing the differences in costs and MACE avoided from the perspective of the Statutory Health Insurance (SHI). Independent on pre-test probability (PTP) of SCAD, complete guideline adherence for usage of CA would result in a slightly lower rate of MACE (-0.0017) and less cost (€-807) per person compared with real-world guideline adherence. While cost savings were shown for moderate and low PTP (€901 and €502, respectively), for a high PTP, a guideline-adherent process results in slightly higher costs (€78) compared with real-world guideline adherence. Sensitivity analyses confirmed the results. CONCLUSION: Our analysis indicates that improving guideline adherence in clinical practice by reducing the amount of CAs in patients with SCAD would lead to cost savings for the German SHI.

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.

Testing a single item screener to support family doctors in identifying patients with limited health literacy: convergent validity of the SILS and the HLS-EU-Q16.

BACKGROUND: Low health literacy (HL) is associated with reduced disease self-management skills, worse health outcomes, an increased number of hospitalizations, more frequent use of the emergency room and less utilization of preventive services. To support patients with low HL it is crucial to identify affected patients. HL is a multidimensional construct, which covers different skills and abilities to make informed health decisions. Validated brief screening tools to assess health-literacy-related skills or abilities in primary care settings are currently not available in German. This study aimed to validate a single item screener developed in the US for the German primary care setting. METHODS: Our study used cross-sectional data from a survey among mainly chronically ill patients (n = 346) conducted in family practices in the state of North Rhine-Westphalia. We explored the convergent validity between a single item literacy screener (SILS) and the HLS-EU-Q16. The SILS measures functional HL by asking patients about their need for help when reading information materials. The HLS-EU-Q16 is a multidimensional HL measure frequently used for research purposes in Germany. Associations between the two instruments were examined using Spearman's correlations and regression analyses. The diagnostic performance of the SILS relative to the HLS-EU-Q16 was assessed using receiver operator curves (ROC). RESULTS: The SILS had a statistically significant correlation with the HLS-EU-Q16 (Spearman ρ: 0.35) and explained 26% of its total variance. Stratified analyses of the convergent validity between both instruments by age, sex, migration background, education level and chronic disease status showed moderate statistically significant correlations in all subgroups (range: 0.223 to 0.428). With an area under the curve of 0.66, the receiver operator curve indicated a satisfactory diagnostic performance of the SILS relative to the HLS-EU-Q16. CONCLUSIONS: The SILS provided an acceptable initial assessment of HL limitations among a heterogeneous population of mainly chronically ill patients in a primary care setting. With only one item, the SILS can be a short and effective tool for routine use in primary care and specialized care settings. Future research should test the SILS in other populations and pilot applications of the SILS in routine care.

Cost-effectiveness of the MitraClip device in German heart failure patients with secondary mitral regurgitation.

AIM: To evaluate the cost-effectiveness of the MitraClip device (MitraClip) in addition to optimal medical therapy (OMT) in patients with heart failure and secondary mitral regurgitation in Germany. METHODS AND RESULTS: A model-based economic evaluation was performed to estimate the incremental cost per quality-adjusted life-years (QALYs) for patients with a moderate-to-severe or severe secondary mitral regurgitation receiving MitraClip plus OMT compared with OMT alone from the statutory health insurance (SHI) perspective. Transition probabilities, data on survival rates, and hospitalization rates were obtained from the COAPT trial, a randomized-controlled multicenter trial. Data on health utility and costs were taken from published evidence. To assess parameter uncertainty, several deterministic and probabilistic sensitivity analyses were performed. The incremental costs per QALY gained were € 59,728 (costs/incremental life years gained: € 42,360). The results were most sensitive to the transition probabilities and the hospitalization rates. The probabilistic sensitivity analysis showed that the MitraClip strategy was cost-effective with a probability of 80% at a willingness-to-pay threshold of € 67,000/QALY. CONCLUSIONS: Depending on the willingness-to-pay threshold, for patients with heart failure and a moderate-to-severe or severe secondary mitral regurgitation the MitraClip can be cost-effective from the perspective of the German SHI.

Hemodialysis and Peritoneal Dialysis in Germany from a Health Economic View-A Propensity Score Matched Analysis.

BACKGROUND: Hemodialysis (HD) and peritoneal dialysis (PD) are deemed medically equivalent for therapy of end-stage renal disease (ESRD) and reimbursed by the German statutory health insurance (SHI). However, although the home dialysis modality PD is associated with higher patient autonomy than HD, for unknown reasons, PD uptake is low in Germany. Hence, we compared HD with PD regarding health economic outcomes, particularly costs, as potentially relevant factors for the predominance of HD. METHODS: Claims data from two German health insurance funds were analysed in a retrospective cohort study regarding the prevalence of HD and PD in 2013-2016. Propensity score matching created comparable HD and PD groups (n = 436 each). Direct annual health care costs were compared. A sensitivity analysis included a comparison of different matching techniques and consideration of transportation costs. Additionally, hospitalisation and survival were investigated using Poisson regression and Kaplan-Meier curves. RESULTS: Total direct annual average costs were higher for HD (€47,501) than for PD (€46,235), but not significantly (p = 0.557). The additional consideration of transportation costs revealed an annual cost advantage of €7000 for PD. HD and PD differed non-significantly in terms of hospitalisation and survival rates (p = 0.610/p = 0.207). CONCLUSIONS: PD has a slight non-significant cost advantage over HD, especially when considering transportation costs.

Early economic modeling of magnetic resonance image-guided high intensity focused ultrasound compared to radiotherapy for pain palliation of bone metastases.

Introduction: Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU) is a non-invasive treatment option for palliative patients with painful bone metastases. Early evidence suggests that MR-HIFU is associated with similar overall treatment response, but more rapid pain palliation compared to external beam radiotherapy (EBRT). This modelling study aimed to assess the cost-effectiveness of MR-HIFU as an alternative treatment option for painful bone metastases from the perspective of the German Statutory Health Insurance (SHI). Materials and methods: A microsimulation model with lifelong time horizon and one-month cycle length was developed. To calculate the incremental cost-effectiveness ratio (ICER), strategy A (MR-HIFU as first-line treatment or as retreatment option in case of persistent pain or only partial pain relief after EBRT) was compared to strategy B (EBRT alone) for patients with bone metastases due to breast, prostate, or lung cancer. Input parameters used for the model were extracted from the literature. Results were expressed as EUR per quality-adjusted life years (QALYs) and EUR per pain response (i.e., months spent with complete or partial pain response). Deterministic and probabilistic sensitivity analyses (PSA) were performed to test the robustness of results, and a value of information analysis was conducted. Results: Compared to strategy B, strategy A resulted in additional costs (EUR 399) and benefits (0.02 QALYs and 0.95 months with pain response). In the base case, the resulting ICERs (strategy A vs. strategy B) are EUR 19,845/QALY and EUR 421 per pain response. Offering all patients MR-HIFU as first-line treatment would increase the ICER by 50% (31,048 EUR/QALY). PSA showed that at a (hypothetical) willingness to pay of EUR 20,000/QALY, the probability of MR-HIFU being cost-effective was 52%. The expected value of perfect information (EVPI) for the benefit population in Germany is approximately EUR 190 Mio. Conclusion: Although there is considerable uncertainty, the results demonstrate that introducing MR-HIFU as a treatment alternative for painful bone metastases might be cost-effective for the German SHI. The high EVPI indicate that further studies to reduce uncertainty would be worthwhile.

Health Literacy among Pregnant Women in a Lifestyle Intervention Trial.

Health literacy plays a crucial role during pregnancy, influencing the mother's health behavior which in turn affects the unborn child's health. To date, there are only few studies that report on health literacy among pregnant women or even interventions to promote health literacy. GeMuKi (acronym for "Gemeinsam Gesund: Vorsorge plus für Mutter und Kind"-Strengthening health promotion: enhanced check-up visits for mother and child) is a cluster-randomized controlled trial, aimed at improving health literacy in pregnant women by means of a lifestyle intervention in the form of brief counseling. The women in the intervention group receive counseling on lifestyle topics, such as nutrition and physical activity, during their regular prenatal check-ups. The counseling is tailored to the needs of pregnant women. Demographic data is collected at baseline using a paper-based questionnaire. Data on health literacy is collected using the Health Literacy Survey Europe with 16 items (HLS-EU-16) at baseline and the Brief Health Literacy Screener (BHLS) questionnaire at two points during the pregnancy by means of an app, which was developed specifically for the purpose of the project. The results of the study indicate that around 61.9% of the women participating in the GeMuKi study have an adequate level of health literacy at baseline. The regression analyses (general estimating equations) showed no significant effect of the GeMuKi intervention on general health literacy as measured by the BHLS (ß = 0.086, 95% CI [-0.016-0.187]). However, the intervention was significantly positively associated with pregnancy specific knowledge on lifestyle (ß = 0.089, 95% CI [0.024-0.154]). The results of this study indicate that GeMuKi was effective in improving specific pregnancy related knowledge, but did not improve general health literacy.

Evaluation of two evidence-based decision aids for female BRCA1/2 mutation carriers in Germany: study protocol for a randomised controlled parallel-group trial.

BACKGROUND: Women with BRCA1/2 mutations have a higher risk of developing breast and ovarian cancer compared to women of the general population. Various preventive options are available to deal with the increased risk of developing cancer. These include intensified breast cancer screening and risk-reducing bilateral mastectomy and salpingo-oophorectomy. The choice of a preventive option can lead to increased decisional conflict. To support these women in their decision-making process, two evidence-based decision aids were developed in an upstream research process and adapted to the German healthcare context. These will be evaluated within a randomised controlled trial (RCT) in terms of their effects on decision-making, women's level of information and psychological outcome variables. METHODS: A sample of 310 women carrying BRCA1/2 mutations (A) without a history of cancer or (B) with a history of unilateral breast cancer who have received post-test genetic counselling will be enrolled. Upon study consent, women will be randomly assigned to either the intervention or the control group. All participants will receive standard care including a physician's letter summarising the counselling content. After baseline data collection (t0), the intervention group receives the respective decision aid while the control group receives standard care only. The primary outcome variable assessed at a 3-month follow-up (t1) is the change of extent in decisional conflict (measured with the Decisional Conflict Scale). Secondary outcome variables comprise the stage of decision-making, self-reported symptoms of anxiety, depression and stress due to the genetic test result, and knowledge regarding cancer risks and preventive options. At t1, the extent of preparation for decision-making and acceptability of the decision aids will also be examined. Another secondary outcome variable assessed at 6-month follow-up (t2) is the extent of decision regret. DISCUSSION: These will be the first decision aids available for BRCA1/2 mutation carriers in Germany to be evaluated regarding their effectiveness and acceptability in clinical use within an RCT. Subsequently, they are to be integrated into the care concept of the centres of the German Consortium for Hereditary Breast and Ovarian Cancer and the affiliated breast centres. TRIAL REGISTRATION {2A}: DRKS DRKS00015823 . Retrospectively registered on 14 June 2019.

Understanding Determinants of Pregnant Women's Knowledge of Lifestyle-Related Risk Factors: A Cross-Sectional Study.

Research indicates that a woman's lifestyle during pregnancy influences her child's health and development. Therefore, women need to possess sufficient knowledge regarding the elements of a healthy lifestyle during pregnancy. To date, there has been little research on the assessment of lifestyle knowledge of pregnant women in the perinatal healthcare setting. This study describes the development and application of a knowledge-based questionnaire for pregnancy to be used in a lifestyle intervention trial conducted in Germany. Within the trial, pregnant women receive counselling on lifestyle topics. These topics are based on the German initiative 'Healthy Start-Young Family Network' (GiL), which provides evidence-based recommendations regarding diet and lifestyle before and during pregnancy. These serve as a basis for health professionals who provide counselling on healthy lifestyle choices during the antenatal period. The questionnaire consists of eight items, each of which can be answered using 'Yes', 'No' or 'Don't know'. The pregnant women who completed the questionnaire at baseline around the twelfth week of gestation were recruited within the host trial from gynaecological practices in Germany. Demographic variables and the respondents' answers to the questionnaire were analysed using descriptive statistics and regression analyses. Descriptive statistics show that more than 85% of participants answered the majority of questions (n = 5) correctly. Questions on whether tap water is safe and the normal range for gestational weight gain (GWG) were answered correctly by about 62% and 74% of the women, respectively, and the question on whether it is beneficial to obtain information on breastfeeding at an early stage was answered correctly by about 29%. The results of the regression analyses indicate that age, gestational week, education and income are positive predictors for answering the questionnaire correctly. Nullipara and migration background are predictors for answering the questions incorrectly. This study indicates that there are gaps in women's knowledge regarding lifestyle during pregnancy. Particular focus on certain topics, such as breastfeeding and normal GWG ranges, is still required during counselling. Our analysis shows that migration background is a predictor of insufficient knowledge and incorrect answers to the questions. Women with such backgrounds require special attention during antenatal counselling in order to cater to their needs and the gaps in their knowledge.

A cross-sectional analysis of health literacy: patient- versus family doctor-reported and associations with self-efficacy and chronic disease.

BACKGROUND: Adequate health literacy (HL) levels contribute to good health outcomes and successful disease self-management in patients with chronic disease. Hence, it is essential that family doctors recognize patients with inadequate HL in need of additional support. This study had two aims: (1) to assess and compare patient self-reported versus family doctor-rated HL estimates, and (2) to explore associations between patient-reported HL, self-efficacy and chronic diseases. METHODS: Participants in this cross-sectional survey were recruited through general practices in North Rhine-Westphalia, Germany. Patient self-reported HL was measured using the European Health Literacy Survey-16. Family doctor-rated HL was measured with an adapted version of this instrument. Using crosstabulations patient-reported and family doctor-rated HL estimates were compared for 346 patient-family doctor pairs. Associations between HL, self-efficacy and chronic disease were investigated using regression analyses. RESULTS: Patient-reported and family doctor-rated HL estimates were concordant in 38% of all cases. On average family doctors rated their patients' HL lower than patients rated their own HL. The lower average family doctor ratings were more pronounced when patients were older, male and had more than one chronic disease. Female family doctors rated HL of male patients lower than their male colleagues. Patient reported HL had a significant positive association with self-efficacy. Mediation analysis provided support that self-efficacy acts as mediator between HL and the number of chronic diseases. CONCLUSIONS: Our study findings indicate a significant discrepancy between patients' self-reported HL and externally rated HL by family doctors. A more systematic utilization of HL screeners might help reduce this discrepancy. At the same time, consideration should be given to enhancing communication training for family doctors and addressing critical HL skills in patient education.

Early Referral to Nephrological Care and the Uptake of Peritoneal Dialysis. An Analysis of German Claims Data.

BACKGROUND: Hemodialysis (HD) and peritoneal dialysis (PD) are medically equivalent alternatives for symptomatic therapy of end-stage renal disease (ESRD). An early referral (ER) of patients with chronic kidney disease (CKD) to a nephrological specialist is associated with a higher proportion of patients choosing PD. Germany historically shows a low PD uptake. This article is the first investigation into the impact of ER on the uptake of PD, using a large German claims database. METHODS: Claims data of 4727 incident dialysis patients in 2015 and 2016 were analyzed. Accounting codes for nephrological care and dialysis modalities were identified. Their first documentation was defined as their first encounter with a nephrologist and their first dialysis treatment (HD or PD). ER was determined as receiving nephrological care at least six months before the first dialysis. A multivariate logistic regression model with adjusted odds ratios (AOR) investigates the impact of ER, outpatient dialysis start, age, comorbidities, and sex on the chance for PD. RESULTS: Forty-three percent were referred to the nephrologist six months before their first dialysis (ER). Single tests, as well as the adjusted multivariate logistic regression, highlighted that ER significantly increases the chance for PD. In the multivariate model, the uptake of PD was associated with ER (AOR = 3.05; p < 0.001; 95% CI = 2.16-4.32), outpatient dialysis start (AOR = 0.71; p = 0.044; 95% CI = 0.51-0.99), younger age (AOR = 0.96; p < 0.001; 95% CI = 0.95-0.97), and fewer comorbidities (AOR = 0.85; p < 0.001; 95% CI = 0.44-1.58). CONCLUSIONS: ER of patients with CKD to a nephrologist increases PD uptake. It gives both nephrologists and patients enough time for patient education about different treatment options and can contribute to informed decisions about the dialysis treatment.

Health literacy among pregnant women in a lifestyle intervention trial: protocol for an explorative study on the role of health literacy in the perinatal health service setting.

INTRODUCTION: Pregnancy is a vulnerable period that affects long-term health of pregnant women and their unborn infants. Health literacy plays a crucial role in promoting healthy behaviour and thereby maintaining good health. This study explores the role of health literacy in the GeMuKi (acronym for 'Gemeinsam Gesund: Vorsorge plus für Mutter und Kind'-Strengthening health promotion: enhanced check-up visits for mother and child) Project. It will assess the ability of the GeMuKi lifestyle intervention to positively affect health literacy levels through active participation in preventive counselling. The study also explores associations between health literacy, health outcomes, health service use and effectiveness of the intervention. METHODS AND ANALYSIS: The GeMuKi trial has a hybrid effectiveness-implementation design and is carried out in routine prenatal health service settings in Germany. Women (n=1860) are recruited by their gynaecologist during routine check-up visits before 12 weeks of gestation. Trained healthcare providers carry out counselling using motivational interviewing techniques to positively affect health literacy and lifestyle-related risk factors. Healthcare providers (gynaecologists and midwives) and women jointly agree on Specific, Measurable, Achievable Reasonable, Time-Bound goals. Women will be invited to fill in questionnaires at two time points (at recruitment and 37th-40th week of gestation) using an app. Health literacy is measured using the German version of the Health Literacy Survey-16 and the Brief Health Literacy Screener. Lifestyle is measured with questions on physical activity, nutrition, alcohol and drug use. Health outcomes of both mother and child, including gestational weight gain (GWG) will be documented at each routine visit. Health service use will be assessed using social health insurance claims data. Data analyses will be conducted using IBM SPSS Statistics, version 26.0. These include descriptive statistics, tests and regression models. A mediation model will be conducted to answer the question whether health behaviour mediates the association between health literacy and GWG. ETHICS AND DISSEMINATION: The study was approved by the University Hospital of Cologne Research Ethics Committee (ID: 18-163) and the State Chamber of Physicians in Baden-Wuerttemberg (ID: B-F-2018-100). Study results will be disseminated through (poster) presentations at conferences, publications in peer-reviewed journals and press releases. TRAIL REGISTRATION: German Clinical Trials Register (DRKS00013173). Registered pre-results, 3rd of January 2019, https://www.drks.de.

Health Literacy in Pregnant Women: A Systematic Review.

Health literacy plays a crucial role during pregnancy, as the mother's health behavior influences both her own health and that of her child. To the authors' best knowledge, no comprehensive overview on evidence of the health literacy of pregnant women and its impact on health outcomes during pregnancy exists. Therefore, this review aims to assess health literacy levels in pregnant women, whether health literacy is associated with outcomes during pregnancy and whether effective interventions exist to improve the health literacy of pregnant women. A systematic literature search was conducted in PubMed and EBSCO, resulting in 14 studies. The results show mixed levels of health literacy in pregnant women. Limited health literacy is associated with unhealthy behaviors during pregnancy. Mixed health literacy levels can be attributed to the recruitment site, the number of participants and the measurement tool used. Quality assessment reveals that the quality of the included studies is moderate to good. The review revealed that randomized controlled trials and interventions to improve health literacy in pregnant women are rare or do not exist. This is crucial in the light of the mixed health literacy levels found among pregnant women. Healthcare providers play a key role in this context, as pregnant women with limited health literacy rely on them as sources of health information.

Predictive modeling to identify potential participants of a disease management program hypertension.

BACKGROUND: Based on the premise of limited health-care resources, decision-makers pursue to allocate disease management programs (DMP) more targeted. METHODS: Based on routine data from a private health insurance company, a prediction model was developed to estimate the individual risk for future in-patient stays of patients eligible for a DMP Hypertension. The database included anonymous claims data of 38,284 policyholders with a diagnosis in the year 2013. A cutoff point of ≥70% was used for selecting candidates with a risk for future hospitalization. Using a logistic regression model, we estimated the model's prognostic power, the occurrence of clinical events, and the resource use. RESULTS: Overall, the final model shows acceptable prognostic power (detection rate = 64.3%; sensitivity = 68.7%; positive predictive value (PPV) = 64.1%, area under the curve (AUC) = 0.72). The comparison between the selected hypothetical DMP-group with a predicted (LOH) ≥70% showed additional costs of about 69% for the DMP-group compared to insure with a LOH <70%. CONCLUSION: The predictive analytical approach may identify potential DMP participants with a high risk of increased health services utilization and in-patient stays.

Patient-centered care during the last year of life: adaptation and validation of the German PACIC short form for bereaved persons as proxies (PACIC-S9-proxy).

BACKGROUND: Providing patient-centered care (PCC) during the last year of life (LYOL) can be challenging due to the complexity of the patients' medical, social and psychological needs, especially in case of chronic illnesses. Assessing PCC can be helpful in identifying areas for improvements. Since not all patients can be surveyed, a questionnaire for proxy informants was developed in order to retrospectively assess patient-centeredness in care during the whole LYOL. This study aimed to evaluate the feasibility and validity of an adapted version of the German Patient Assessment of Chronic Illness Care (PACIC) for surveying bereaved persons in order to assess PCC during the decedents' LYOL. METHODS: The German PACIC short form (11 items) was adapted to a nine-item version for surveying bereaved persons on the decedent's LYOL (PACIC-S9-Proxy). Items were rated on a five-point Likert scale. The PACIC adaptation and validation was part of a cross-sectional survey in the region of Cologne. Participants were recruited through self-selection and active recruitment by practice partners. Sociodemographic characteristics and missing data were analyzed using descriptive statistics. An exploratory factor analysis was conducted in order to assess the structure of the PACIC-S9-Proxy. Internal consistency was estimated using Cronbach's alpha. RESULTS: Of the 351 informants who participated in the survey, 230 (65.52%) considered their decedent to have suffered from chronic illness prior to death. 193 of these informants (83.91%) completed ≥5 items of the questionnaire and were included in the analysis. The least answered item was item (74.09%) was item 4 (encouragement to group & classes for coping). The most frequently answered item (96.89%) was item 2 (satisfaction with care organization). Informants rated the item" Given a copy of their treatment plan" highest (mean 3.96), whereas "encouragement to get to a specific group or class to cope with the condition" (mean 1.74) was rated lowest. Cronbach's alpha was 0.84. A unidimensional structure of the questionnaire was found (Kaiser-Meyer-Olkin 0.86, Bartlett's test for sphericity p < 0.001), with items' factor loadings ranging from 0.46 to 0.82. CONCLUSIONS: The nine-item questionnaire can be used as efficient tool for assessing PCC during the LYOL retrospectively and by proxies. TRIAL REGISTRATION: The study was registered in the German Clinical Trials Register ( DRKS00011925 ) on 13 June 2017.

Comparison of Patient and Proxy Assessment of Patient-Centeredness in the Care of Coronary Heart Disease: A Cross Sectional Survey Using the PACIC-S11.1.

INTRODUCTION: When making medical care more patient-centered, surveys on patients' and their relatives' experiences can be helpful in identifying opportunities for improvement. In cases where the targeted patients are unable to express their own perspective, for example, due to them being too young or suffering from severe impairments, proxies can serve as substitutes. Proxies are frequently used in care planning and consent. Nevertheless, it is unclear whether patients' assessments of how patient-centered their medical care is are similar to those of their proxies. This study aims to assess the level of consistency between patients' and their proxies' assessments using an adapted version of the Patient Assessment of Chronic Illness Care (PACIC) short form questionnaire. METHODS: In a cross-sectional study, patients with coronary heart disease were recruited at cardiologists' offices, rehabilitation clinics and hospitals. Participants were surveyed with regard to the perceived level of patient-centeredness during their care using an adapted version of the German PACIC short form (PACIC-S11.1). Correlations in the assessments made by each patient and their respective proxy were analyzed. On the level of the patients group and the relatives group differences between mean ratings for each item were compared using paired t-tests. RESULTS: In total, 74 pairs of patients and proxies submitted the completed questionnaire. On the level of the individual patient/proxy pairs, no correlation, or significant but low correlation, was found between the ratings. On the group level, patients' and their proxies' item ratings were similar in the interpretation of averages, but still demonstrated statistically significant differences. Overall, patients rated their care as more patient-centered than their proxies did. CONCLUSION: The study shows that, on the individual level, proxies' ratings do not necessarily reflect the patients' assessment of PCC. On the group level, the assessments of relatives regarding PCC are similar to those of the patients. TRIAL REGISTRATION: German clinical trials register (Deutsches Register Klinischer Studien, DRKS) Registration Number: DRKS00012434 (URL: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00012434).

[Do decision-makers in the German healthcare system misjudge the situation of a branch office? - Motivation of physicians to set up in a GP's practice in the area of the Association of Statutory Health Insurance Physicians North-Rhine]. / Schätzen Entscheider im Gesundheitswesen die Niederlassungssituation falsch ein?

BACKGROUND: The aim of the study was to illustrate motives for a GP's branch from the current point of view by branch (expectations fulfilled) and before branch (motivation). In addition, obstructive or beneficial factors of a branch should be identified. METHODS: Using a mixed-methods approach (focus groups, individual interviews) with the target group were used in the qualitative part of experiences, opinions and motivations for the GP's branch and, after evaluation, a pre-tested questionnaire was used. A full survey of 675 identified GPs from the database of the Association of Statutory Health Insurance Physicians North Rhine was carried out. These had settled in the last 5 years before the survey period (09/2015). The questionnaire sent by post contained 17 questions on settlement motivation and 11 biographical aspects. RESULTS: The number of evaluable data records was 437 (64.7 %). The highest approval values, in the sense of conducive to settlement motivation, were "discontinuation of services in the hospital" (97.2 %) and "being one's own boss" (96.2 %). Rights and duties as a "panel physician" (8.5 %), and the "emergency service for panel physicians/on-call service" (22.7 %) were perceived as more of an obstacle. In terms of fulfilling expectations, the "discontinuation of services" (95.6 %) and the "diversity of age groups to be treated" (88.9 %) emerged. A total of 97 % would settle down again, regardless of the degree to which their wishes were fulfilled, and almost ¾ would only decided to work as family doctors after they had completed their studies. CONCLUSIONS: The fact that escaping from the stationary sector is the main driving force behind the settlement must be thought-provoking. Since this survey approach was not based on specialist groups or the level of training, but on a complete survey of established persons over a five-year period, it can be stated that the current incentive structures of a branch should be rethought due to the age structure of the interviewees.