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.

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.

[General practitioners' perspectives on the perceived effectiveness of the disease management programs for type 2 diabetes and coronary heart disease: Results of a focus group study]. / Die wahrgenommene Effektivität der Disease Management Programme für Diabetes mellitus Typ 2 und Koronare Herzkrankheit aus Sicht von Hausärzt*innen ­ Ergebnisse einer Fokusgruppenstudie.

BACKGROUND: The majority of patients in disease management programs (DMPs) for type 2 diabetes (T2DM) and coronary heart disease (CHD) in Germany are enrolled by their general practitioner (GP). The aim of this study was, in the context of upcoming DMP expansions, to elicit GPs' current experiences and opinions regarding the perceived effectiveness and acceptance of the DMPs T2DM and CHD, as well as to determine beneficial and hindering aspects of the implementation of these programs from a GP's perspective. METHODS: In August and September 2020, 20 GPs of teaching practices of the University Hospital Cologne with experiences in DMPs were interviewed in semi-structured focus group discussions. Their expectations, attitudes and opinions regarding the DMPs T2DM and CHD were evaluated and analyzed according to the content-structuring qualitative content analysis by Kuckartz. RESULTS: The DMP T2DM was rated as generally positive by the respondents due to the structured treatment including regular foot and eye examinations, close patient contacts and perceptions of improved health outcomes. The DMP CHD was rated more negatively by the respondents because of a high and partly unnecessary documentation workload and limited therapeutic freedom, leading to a perceived ineffectiveness for patients' health outcomes. Thus, there was a discrepancy in the perceived effectiveness of the examined DMPs, causing a lower acceptance of the DMP CHD. Therefore, some of the respondents tended to enroll fewer patients into the DMP CHD or to drop out of the DMP CHD. DISCUSSION: In order to increase the acceptance and sustainability of DMPs some elements of the DMP CHD as well as the remuneration and the documentation need to be reconsidered. Additionally, future studies on the acceptance of DMPs should differentiate between different DMPs in order to generate valid results.

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.

Patient Portals as Facilitators of Engagement in Patients With Diabetes and Chronic Heart Disease: Scoping Review of Usage and Usability.

BACKGROUND: Patient portals have the potential to improve care for chronically ill patients by engaging them in their treatment. These platforms can work, for example, as a standalone self-management intervention or a tethered link to treatment providers in routine care. Many different types of portals are available for different patient groups, providing various features. OBJECTIVE: This scoping review aims to summarize the current literature on patient portals for patients with diabetes mellitus and chronic heart disease regarding usage behavior and usability. METHODS: We conducted this review according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement for scoping reviews. We performed database searches using PubMed, PsycInfo, and CINAHL, as well as additional searches in reviews and reference lists. We restricted our search to 2010. Qualitative and quantitative studies, and studies using both approaches that analyzed usage behavior or usability of patient portals were eligible. We mapped portal features according to broad thematic categories and summarized the results of the included studies separately according to outcome and research design. RESULTS: After screening, we finally included 85 studies. Most studies were about patients with diabetes, included patients younger than 65 years, and were conducted in the United States. Portal features were categorized into educational/general information, reminder, monitoring, interactivity, personal health information, electronic/personal health record, and communication. Portals mostly provided educational, monitoring, and communication-related features. Studies reported on usage behavior including associated variables, usability dimensions, and suggestions for improvement. Various ways of reporting usage frequency were identified. A noticeable decline in portal usage over time was reported frequently. Age was most frequently studied in association with portal use, followed by gender, education, and eHealth literacy. Younger age and higher education were often associated with higher portal use. In two-thirds of studies reporting on portal usability, the portals were rated as user friendly and comprehensible, although measurement and reporting were heterogeneous. Portals were considered helpful for self-management through positive influences on motivation, health awareness, and behavioral changes. Helpful features for self-management were educational/general information and monitoring. Barriers to portal use were general (eg, aspects of design or general usability), related to specific situations during portal use (eg, login procedure), or not portal specific (eg, user skills and preferences). Frequent themes were aspects of design, usability, and technology. Suggestions for improvement were mainly related to technical issues and need for support. CONCLUSIONS: The current state of research emphasizes the importance of involving patients in the development and evaluation of patient portals. The consideration of various research designs in a scoping review is helpful for a deeper understanding of usage behavior and usability. Future research should focus on the role of disease burden, and usage behavior and usability among older patients.

[Digital Transformation of Healthcare: A Delphi Study of the Working Groups Digital Health and Validation and Linkage of Secondary Data of the German Network for Health Services Research (DNVF)]. / Digitale Transformation des Gesundheitswesens ­ eine Delphi-Studie der Arbeitsgruppen Digital Health und Validierung und Linkage von Sekundärdaten des Deutschen Netzwerk Versorgungsforschung (DNVF).

AIM OF THE STUDY: The digital transformation in healthcare is also of fundamental importance for healthcare research. For this reason, experts should agree on, prioritize and identify key topics for a medium-term strategy of the German Network for Health Services Research and classify the general development of digital health in the context of health services research. METHODS: Between April and September 2018, the working groups "Digital Health" and "Validation and Linkage of Secondary Data" of the German Network for Health Services Research were asked to submit their expertise online using the methodological approach of a Delphi study. For this purpose, a multi-stage modified Delphi method with quantitative and qualitative approaches was chosen. Initially, a list of theses was drawn from the network's published position papers on digital health applications and medical apps. A total of 131 statements were formulated. The final survey instrument included questions on the biographical background of the participants, 42 developed items (33 statements and 8 open-ended questions), and one free-text field to add further aspects. Items were evaluated with a five-point Likert scale. A statement was accepted if the agreement rate was 75% or higher. RESULTS: Of the 110 potential participants, 50 (46%) took part in the first round and 39 (36%) in the second round of the Delphi survey. In the first round, there was a clear result for 24 of 33 statements. There were 20 statements "agreed with" and four "disagreed with." Nine statements were between 60 and 75% and were presented to the participants again for evaluation in the second round. In round two, of these nine statements, four statements were "agreed with" and five statements were "disagreed with." Digital Health Literacy" emerged as a particular focus in this Delphi study. CONCLUSION: In this Delphi study, experts were involved in selecting and prioritizing possible topics for the Digital Health working group and assessing future developments in digital health in the context of health services research. The results reflect both the expectations and interests of the members and are largely consistent with the recommendations of the report "Digitalization for Health" made by the expert council for assessing developments in the health sector.

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.

How Can Cardiac Rehabilitation Promote Health Literacy? Results from a Qualitative Study in Cardiac Inpatients.

After acute care of a cardiac event, cardiac rehabilitation helps future disease management. Patients with low health literacy have been shown to have fewer knowledge gains from rehabilitation and higher all-cause mortality after acute cardiac events. Cardiac rehabilitation may be the best channel to target population with low health literacy, yet research on this topic is limited. Consequently, the main aim of the current study was to identify patient perceptions about the health literacy domains that are needed for successful rehabilitation of patients attending German cardiac rehabilitation clinics after an acute cardiac event. Five focus group interviews with 25 inpatients (80% male, 20% female) were conducted at a cardiac rehabilitation clinic in Germany. Patients were eligible to participate if they had sufficient understanding of the German language and had no other debilitating diseases. Patients identified five domains of health literacy for rehabilitation success: knowledge about their health condition; being able to find and evaluate health-related information, being able to make plans and sticking to them, assumption of responsibility over one's health and the ability to ask for and receive support. The results give an important insight into what patients perceive as important components of their cardiac rehabilitation, which can provide the basis for developing the health literacy of patients and how cardiac rehabilitation clinics respond to the recovery needs of their patients.

A pragmatic randomised controlled trial referring to a Personalised Self-management SUPport Programme (P-SUP) for persons enrolled in a disease management programme for type 2 diabetes mellitus and/or for coronary heart disease.

BACKGROUND: Type 2 diabetes mellitus (T2DM) and coronary heart disease (CHD) are two chronic diseases that cause a tremendous burden. To reduce this burden, several programmes for optimising the care for these diseases have been developed. In Germany, so-called disease management programmes (DMPs), which combine components of Disease Management and the Chronic Care Model, are applied. These DMPs have proven effective. Nevertheless, there are opportunities for improvement. Current DMPs rarely address self-management of the disease, make no use of peer support, and provide no special assistance for persons with low health literacy and/or low patient activation. The study protocol presented here is for the evaluation of a programme that addresses these possible shortcomings and can be combined with current German DMPs for T2DM and CHD. This programme consists of four components: 1) Meetings of peer support groups 2) Personalised telephone-based health coaching for patients with low literacy and/or low patient activation 3) Personalised patient feedback 4) A browser-based web portal METHODS: Study participants will be adults enrolled in a DMP for T2DM and/or CHD and living in North Rhine-Westphalia, a state of the Federal Republic of Germany. Study participants will be recruited with the assistance of their general practitioners by the end of June 2021. Evaluation will be performed as a pragmatic randomised controlled trial with one intervention group and one waiting control group. The intervention group will receive the intervention for 18 months. During this time, the waiting control group will continue with usual care and the usual measures of their DMPs. After 18 months, the waiting control group will also receive a shortened intervention. The primary outcome is number of hospital days. In addition, the effects on self-reported health-state, physical activity, nutrition, and eight different psychological variables will be investigated. Differences between values at month 18 and at the beginning will be compared to judge the effectiveness of the intervention. DISCUSSION: If the intervention proves effective, it may be included into the DMPs for T2DM and CHD. TRIAL REGISTRATION: The study was registered in the German Clinical Trials Registry (Deutsches Register Klinischer Studien (DRKS)) in early 2019 under the number 00020592. This registry has been affiliated with the WHO Clinical Trials Network ( https://www.drks.de/drks_web/setLocale_EN.do ) since 2008. It is based on the WHO template, but contains some additional categories for which information has to be given ( https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields ). A release and subsequent number assignment only take place when information for all categories has been given.

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.

Development of decision aids for female BRCA1 and BRCA2 mutation carriers in Germany to support preference-sensitive decision-making.

BACKGROUND: Women with pathogenic BRCA1 and BRCA2 mutations possess a high risk of developing breast and ovarian cancer. They face difficult choices when considering preventive options. This study presents the development process of the first decision aids to support this complex decision-making process in the German healthcare system. METHODS: A six-step development process based on the International Patient Decision Aid Standards was used, including a systematic literature review of existing decision aids, a topical medical literature review, preparation of the decision aids, focus group discussions with women with BRCA1/2 mutations, internal and external reviews by clinical and self-help experts, and user tests. All reviews were followed by iterative revisions. RESULTS: No existing decision aids were transferable to the German setting. The medical research revealed a need to develop separate decision aids for women with BRCA1/2 mutations (A) without a history of cancer (previvors) and (B) with a history of unilateral breast cancer (survivors). The focus group discussions confirmed a high level of approval for the decision aids from both target groups. Additionally, previvors requested more information on risk-reducing breast surgery, risk-reducing removal of both ovaries and Fallopian tubes, and psychological aspects; survivors especially wanted more information on breast cancer on the affected side (e.g. biological parameters, treatment, and risk of recurrence). CONCLUSIONS: In a structured process, two target-group-specific DAs for previvors/survivors with BRCA1/2 mutations were developed to support decision-making on risk-adapted preventive options. These patient-oriented tools offer an important addition to existing specialist medical care in Germany.

[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.

TeDia - A Telemedicine-Based Treatment Model for Inpatient and Interprofessional Diabetes Care.

INTRODUCTION: The proportion of hospitalized patients with diabetes as a secondary diagnosis increases continuously. Therefore, we have developed a team-based interprofessional and telemedicine-based diabetes management system named TeDia ("Telemedical Diabetology") and implemented it in an inpatient setting. The aim of the retrospective real-world study was to show the clinical impact of TeDia following its implementation. MATERIAL AND METHODS: TeDia is characterized by an interpersonal and telemedicine-based exchange of hospital routine data between specially trained nurses ("diabetes managers") and external diabetologists. It was implemented in three acute hospitals of the Düsseldorf Catholic Hospital Group in Düsseldorf, Germany. Clinical awareness of diabetes, diabetes-related complications and diagnosis-related group (DRG)-based revenues were analyzed using ICD routine coding. Furthermore, the frequency of HbA1c determinations as well as hospitalization days were investigated. RESULTS: Before (2010), during (2012) and after the implementation of TeDia (2014), the number of patients with ICD coding for diabetes, decompensated diabetes, diabetic neuropathy, diabetic nephropathy as well as complicated diabetes increased by +18%, +93%, +101%, +113% and +89%, respectively. Using the same DRG grouper, revenues increased by +53% (from 27 (2013) to 42 (2014) DRG points). Frequency of HbA1c determinations rose by +85%, whereas the time for an average length of stay decreased by -12% (-0, 91 days) in comparison to patients without diabetes. CONCLUSION: TeDia improved clinical awareness for diabetes and its complications. This new treatment model increased revenues and reduced hospital days indicating enhanced treatment quality. Our findings emphasize the necessity of novel technologies in inpatient settings for the improvement of efficacy, safety and efficiency of diabetes care.

Does task delegation to non-physician health professionals improve quality of diabetes care? Results of a scoping review.

OBJECTIVE: As a result of unhealthy lifestyles, reduced numbers of healthcare providers are having to deal with an increasing number of diabetes patients. In light of this shortage of physicians and nursing staff, new concepts of care are needed. The aim of this scoping review is to review the literature and examine the effects of task delegation to non-physician health professionals, with a further emphasis on inter-professional care. RESEARCH DESIGN AND METHODS: Systematic searches were performed using the PubMed, Embase and Google Scholar databases to retrieve papers published between January 1994 and December 2017. Randomised/non-randomised controlled trials and studies with a before/after design that described the delegation of tasks from physicians to non-physicians in diabetes care were included in the search. This review is a subgroup analysis that further assesses all the studies conducted using a team-based approach. RESULTS: A total of 45 studies with 12,092 patients met the inclusion criteria. Most of the interventions were performed in an outpatient setting with type-2 diabetes mellitus patients. The non-physician healthcare professionals involved in the team were nurses, pharmacists, community health workers and dietitians. Most studies showed significant improvements in glycaemic control and high patient satisfaction, while there were no indications that the task delegation affected quality of life scores. CONCLUSIONS: The findings of the review suggest that task delegation can provide equivalent glycaemic control and potentially lead to an improvement in the quality of care. However, this review revealed a lack of clinical endpoints, as well as an inconsistency between the biochemical outcome parameters and the patient-centred outcome parameters. Given the vast differences between the individual healthcare systems used around the world, further high-quality research with an emphasis on long-term outcome effects and the expertise of non-physicians is needed.

[App-controlled feedback devices can support sustainability of weight loss. Multicentre QUANT-study shows additional weight loss and gain of QoL via multiple feedback-devices in OPTIFAST®52-program]. / App-gesteuerte Feedbackgeräte unterstützen Nachhaltigkeit einer Gewichtsreduktion.

App-controlled feedback devices can support sustainability of weight loss. Multicentre QUANT-study shows additional weight loss and gain of QoL via multiple feedback-devices in OPTIFAST®52-program Objective: Are three app-controlled feedback devices, tested against a simple pedometer in a weight reduction program, supporting sustainable therapy success and quality of life (QoL)? Methods: In this multi-centre randomised controlled study adults with obesity (n = 89, m = 46.5 years, women n = 54), achieved high weight loss (from 42.7 kg/m² to 35.2 kg/m²) while completing the first three month of the OPTIFAST®52-program. Thereafter the intervention group (IG) used feedback devices (BIA scale, blood pressure monitor, step counter), the control group a mechanical pedometer without app for another year. Intention-to-treat analysis (ITT) and As-treated analysis (AT) were carried out. Results: Feedback devices had a positive effect on fat-loss and secondary study objectives like QoL, leading to a better sustainability of these improvements. Participants in IG (AT for t2-t0) had improvements for Waist-to-Height-ratio (WHtR) and physically and mentally quality of life. Conclusion: The results are presumably based on an increase in self-efficacy and the experience of control. Future studies should be preceded by a pilot study to analyse acceptance problems.

Impact of the communication and patient hand-off tool SBAR on patient safety: a systematic review.

OBJECTIVES: Communication breakdown is one of the main causes of adverse events in clinical routine, particularly in handover situations. The communication tool SBAR (situation, background, assessment and recommendation) was developed to increase handover quality and is widely assumed to increase patient safety. The objective of this review is to summarise the impact of the implementation of SBAR on patient safety. DESIGN: A systematic review of articles published on SBAR was performed in PUBMED, EMBASE, CINAHL, Cochrane Library and PsycINFO in January 2017. All original research articles on SBAR fulfilling the following eligibility criteria were included: (1) SBAR was implemented into clinical routine, (2) the investigation of SBAR was the primary objective and (3) at least one patient outcome was reported. SETTING: A wide range of settings within primary and secondary care and nursing homes. PARTICIPANTS: A variety of heath professionals including nurses and physicians. PRIMARY AND SECONDARY OUTCOME MEASURES: Aspects of patient safety (patient outcomes) defined as the occurrence or incidence of adverse events. RESULTS: Eight studies with a before-after design and three controlled clinical trials performed in different clinical settings met the inclusion criteria. The objectives of the studies were to improve team communication, patient hand-offs and communication in telephone calls from nurses to physicians. The studies were heterogeneous with regard to study characteristics, especially patient outcomes. In total, 26 different patient outcomes were measured, of which eight were reported to be significantly improved. Eleven were described as improved but no further statistical tests were reported, and six outcomes did not change significantly. Only one study reported a descriptive reduction in patient outcomes. CONCLUSIONS: This review found moderate evidence for improved patient safety through SBAR implementation, especially when used to structure communication over the phone. However, there is a lack of high-quality research on this widely used communication tool. TRIAL REGISTRATION: none.

Hygiene trained nursing staff at wards ­ What can this additional educated nurses achieve? / Hygienebeauftragte in der Pflege auf den Stationen. Erste Erfahrungen zur Einführung im Universitätsklinikum Köln

Background: Hygiene deficits can cause hospital-acquired infections. To meet this public health problem the Robert Koch-Institute advocates the employment of infection control link nurses (ICLN). Aim: This study aimed to evaluate the experiences of ICLNs working in the University Hospital of Cologne. Method: A cross-sectional survey of all ICLNs (n = 64) working at the University Hospital of Cologne was carried out by a self developed questionaire. The data were assessed descriptively. Results: The return rate was 45.3 % (n = 29). The ICLNs were very satisfied with the ICLN training and felt well prepared for their task. The collaboration with other nursing staff, their head nurse and the Department of Hygiene was also positively evaluated. However, only one third of the respondents was satisfied with their working conditions and only half of them indicated feeling that the efforts they made so far were successful. This study also found that, many of the legal intended services were rarely performed. The study identified two barriers to implementation of ICLNs. On the one hand, the release from other routine nursing duties and on the other hand a lack of acceptance of the role by physicians. Conclusions: The task ahead is to find ways to exempt ICLNs from other duties and to involve the physicians more intensely in the implementation of ICLNs.

Implementation of an innovative hands-on training to improve adherence to hygiene rules: A feasibility Study.

BACKGROUND: Hospital-acquired infections (HAI) still pose a major problem in inpatient care. The single most important measure for preventing HAIs is to improve adherence to hand hygiene among health care professionals. OBJECTIVE: To assess the feasibility of an innovative hands-on training to improve adherence to hygiene rules under standardized and under real life conditions. DESIGN: Before-after controlled cohort trial to assess the feasibility of implementing an innovative hands-on training to improve hand hygiene adherence. SETTING: Large university hospital in Germany. PARTICIPANTS: Fifty trained nurses from three wards with an average age of 32years (±10.22years) and an average vocational experience of 6.85years (±7.54years). METHODS: The intervention consisted of a hands-on training in the skills lab of the University of Cologne complemented by a 12-week observation period before and after the training on participating wards. The training comprised important skills with respect to hand hygiene, venipuncture, dressing changes of central venous catheters, preparation of IV infusions, and donning of gloves using sterile technique. A communication training was included to enable nurses to enforce hygiene rules in their collaboration with peers and physicians. The intervention was taught in small groups with a wide array of interactive teaching methods. It was evaluated using the objective structured clinical examination (OSCE) format. Observations were conducted by a trained infection control nurse. RESULTS: Before (after) the intervention 622 (612) occasions of hand hygiene were documented. A highly significant improvement in hygiene compliance was observed pre- and post-intervention (64.3% vs. 79.2%; p≤0.0001). The OSCE evaluation showed significant improvements in all subscales. CONCLUSION: The developed and conducted hands-on training seems feasible and is successful in significantly improving adherence to hygiene rules under standardized and real life conditions. Whether the effect is stable over time is subject to further investigation.

Parental views on acute otitis media (AOM) and its therapy in children--results of an exploratory survey in German childcare facilities.

BACKGROUND: Acute otitis media (AOM) is one of the main reasons for medical consultation and antibiotic use during childhood. Although 80% of AOM cases are self-limiting, antibiotic prescription is still high, either for physician- or for parent-related factors. This study aims to identify parental knowledge about, beliefs and attitudes towards, and experiences with AOM and its therapy and thus to gain insights into parents' perspectives within the German health care system. METHODS: An exploratory survey was conducted among German-speaking parents of children aged 2 to 7 years who sent their children to a childcare facility. Childcare facilities were recruited by convenience sampling in different urban and rural sites in Germany, and all parents with children at those facilities were invited to participate. Data were evaluated using descriptive statistical analyses. RESULTS: One-hundred-thirty-eight parents participated. Of those, 75.4% (n = 104) were AOM-experienced and 75.4% (n = 104) had two or more children. Sixty-six percent generally agree that bacteria cause AOM. 20.2% generally agree that viruses cause AOM. 30.5% do not generally agree that viruses cause AOM. Eight percent generally agree that AOM resolves spontaneously, whereas 53.6% do not generally agree. 92.5% generally (45.7%) and partly (42.8%) agree that AOM needs antibiotic treatment. With respect to antibiotic effects, 56.6% generally agree that antibiotics rapidly relieve earache. 60.1% generally agree that antibiotics affect the gastrointestinal tract and 77.5% generally agree that antibiotics possibly become ineffective after frequent use. About 40% generally support and about 40% generally reject a "wait-and-see" strategy for AOM treatment. Parental-reported experiences reveal that antibiotics are by far more often prescribed (70.2%) than actively requested by parents (26.9%). CONCLUSIONS: Parental views on AOM, its therapy, and antibiotic effects reveal uncertainties especially with respect to causes, the natural course of the disease and antibiotic effects on AOM. These results indicate that more evidence-based information is needed if parents' health literacy in the treatment of children with AOM is to be enhanced. The discrepancy between reported parental requests for antibiotics and reported actual prescriptions contradicts the hypothesis of high parental influence on antibiotic use in AOM.