Outpatient parenteral antimicrobial therapy (OPAT) in Germany: insights and clinical outcomes from the K-APAT cohort study.

PURPOSE: Outpatient parenteral antimicrobial therapy (OPAT) offers several key advantages, including enhanced patient quality of life, reduced healthcare costs, and a potential reduction of nosocomial infections. It is acknowledged for its safety and effectiveness. This study provides the first systematic clinical data for Germany, where OPAT has not yet been widely adopted. The aim is to establish a foundational reference point for further research and integration of OPAT into the German healthcare system. METHODS: This prospective observational study descriptively analyses data obtained from a cohort of patients receiving OPAT. Both in- and outpatients from all medical specialties could be recruited. Patients administered the anti-infective medications themselves at home using elastomeric pumps. RESULTS: 77 patients received OPAT, with a median duration of 15 days and saving 1782 inpatient days. The most frequently treated entities were orthopaedic infections (n = 20, 26%), S. aureus bloodstream infection (n = 16, 21%) and infectious endocarditis (n = 11, 14%). The most frequently applied drugs were flucloxacillin (n = 18, 23%), penicillin G (n = 13, 17%) and ceftriaxone (n = 10; 13%). Only 5% of patients (n = 4) reported to have missed more than one outpatient dose (max. 3 per patient). Only one catheter-related adverse event required medical intervention, and there were no catheter-related infections. CONCLUSION: The study demonstrates that OPAT can be safely conducted in Germany. In preparation for its broader implementation, crucial next steps include creating medical guidelines, fostering interdisciplinary and inter-sectoral communication, as well as creating financial and structural regulations that facilitate and encourage the adoption of OPAT. TRIAL REGISTRATION NUMBER: NCT04002453.

Lactation support in neonatal intensive care units in Germany from the mothers' perspective - a mixed-method study of the current status and needs.

BACKGROUND: Establishing successful lactation in mothers of very low birth weight (VLBW, <1500g) infants requires structured lactation support. Little is known about mothers' perspectives on lactation support in German neonatal intensive care units (NICUs). METHODS: This paper features a convergent mixed-method approach that includes a retrospective, cross-sectional questionnaire and interview data to showcase mothers' perceptions of lactation support in NICUs. Content analysis of the interviews (n = 12) and a descriptive analysis of quantitative data (n = 533) were performed to illustrate the current status and need for lactation support in German NICUs. RESULTS: The results show that lactation support in German NICUs is often inadequate and does not comply with recommendations based on the existing literature to encourage pumping and breastfeeding in mothers. The data imply that even if lactation is successfully initiated in most cases, it is often not maintained over time, which may be due to a lack of personal support and consistent information. CONCLUSION: The overall structures and institutional guidelines for lactation support should be encouraged to promote nutrition with mother´s own milk in German NICUs.

Pressure to provide milk among mothers of very low birth weight infants: an explorative study.

BACKGROUND: Pump-dependent mothers of very low birth weight (VLBW, < 1500g) infants experience specific challenges achieving sufficient milk supply in the neonatal intensive care unit (NICU) and are therefore less frequently able to achieve (exclusive) breast milk feeding. Stress due to the limitations on participating in the infant's care may contribute to this problem. Some explorative studies suggest that pressure to provide milk may be an additional stressor in mothers. However, the type of pressure to provide milk perceived by mothers of VLBW infants has rarely been examined. METHODS: A retrospective and anonymous questionnaire was conducted with mothers of VLBW infants aged 6 to 24 months at the time of data collection. Quantitative data and written comments were used to examine the mothers' perceptions. Descriptive and bivariate tests (Spearman´s rho, Pearson's chi2) were performed to show correlations between pressure to provide breast milk, parental stress (PSS:NICU: role alteration subscale), milk volume, and maternal factors. Pressure to provide milk was measured through two self-developed single items to differentiate between internal and external pressures. RESULTS: Data of n = 533 mothers of VLBW infants was analysed. More than 70% of the mothers agreed that they pressured themselves to provide milk for their infant. In contrast, 34% of the mothers agreed that they felt pressure from outside to provide milk. Higher milk volume 14 days post-partum was significantly correlated with higher internal (Spearman´s rho = 0.2017, p = 0.000) and higher external pressure to provide milk (Spearman´s rho = 0.2991; p = 0.000). Higher PSS:NICU parental role alteration scores were significantly correlated with more internal (Spearman´s rho = -0.2865, p = 0.000) and more external pressure to provide milk (Spearman´s rho = -0.1478; p = 0.002). Milk volume 14 days post-partum and the PSS:NICU were not significantly correlated (Spearman´s rho = -0.0190; p = 0.701). Qualitative analyses highlighted these results and enhanced the bidirectional relationships between maternal pressure to provide milk and milk volume. CONCLUSIONS: Especially internal pressure to provide milk is perceived by many mothers, being mutually dependent on milk supply and parental stress. Pressure to provide milk may be an important factor to decrease maternal stress in the NICU and, therefore, lead to more positive pumping and breastfeeding experiences. More research and validated instruments are needed to adequately measure pressure to provide milk with its different psychological, social, and environmental dimensions.

Achieving sufficient milk supply supports mothers to cope with premature birth.

AIM: To explore whether and how expressing breast milk is perceived as helpful in coping with negative emotions due to premature birth by mothers of very low birth weight (VLBW) infants. METHODS: Qualitative interviews and a retrospective cross-sectional questionnaire with mothers of VLBW infants were conducted and analysed using an exploratory sequential mixed-method design. Hypotheses were built using qualitative content analysis and quantitatively tested using multivariate regression analysis. RESULTS: Interviews with 12 mothers and questionnaires of 518 mothers were analysed. Coping with prematurity by expressing milk was seen as a way to maintain the caregiving role for the mothers, where three relevant factors arouse: making up for what happened, providing the best for their infant and fear of low milk supply. Quantitative analysis showed that mothers with a high milk supply (Coef. = 1.1, p < 0.000) and more feelings of guilt due to premature birth (Coef. = -0.1; p = 0.015) perceived expressing breast milk significantly more as a resource for coping. CONCLUSION: This study adds knowledge on how expressing breast milk for their VLBW infant may support mothers in coping with premature birth, by revealing the association with milk supply and feelings of guilt due to premature birth.

Exploring patients' perspectives: a mixed methods study on Outpatient Parenteral Antimicrobial Therapy (OPAT) experiences.

BACKGROUND: Outpatient Parenteral Antimicrobial Therapy (OPAT), an alternative to inpatient intravenous antibiotic therapy, has shown benefits in international studies such as increased patient satisfaction. Because OPAT has been used only sporadically in Germany so far, no structured results on patients' experiences and concerns regarding OPAT have yet been available. This study therefore aims to explore the experiences of OPAT patients in a pilot region in Germany. METHODS: This is an observational study in a German pilot region, including a survey of 58 patients on their experiences with OPAT, and in-depth interviews with 12 patients (explanatory-sequential mixed-methods design). RESULTS: Patients reported that they were satisfied with OPAT. That a hospital discharge was possible and anti-infective therapy could be continued in the home environment was rated as being particularly positive. In the beginning, many patients in the interviews were unsure about being able to administer the antibiotic therapy at home on their own. However, healthcare providers (doctors and pharmacy service provider staff) were able to allay these concerns. Patients appreciated regular contact with care providers. There were suggestions for improvement, particularly concerning the organization of the weekly check-up appointments and the provision of information about OPAT. CONCLUSIONS: Patients were generally satisfied with OPAT. However, the treatment structures in Germany still need to be expanded to ensure comprehensive and high-quality OPAT care. TRIAL REGISTRATION: NCT04002453, https://www. CLINICALTRIALS: gov/ , (registration date: 2019-06-21).

Care needs and self-induced measures of women with postpartum pelvic floor disorder- Results of a social media-based survey of 2930 women.

INTRODUCTION: Pelvic floor disorders (PFD) occur in about 40% of women after delivery. Less is known about the intervention and care needs of women with postpartum PFD. The aim of this analysis was to analyze care needs and self-initiated measures to strengthen the pelvic floor in postpartum women in relation to incontinence and sexual dysfunction. Furthermore, influencing factors for self-initiated measures were evaluated. PATIENTS AND METHODS: An anonymous online survey (via LimeSurvey) was conducted between September and October 2022 and distributed via social media (Instagram and Facebook). The survey explicitly addressed mothers with and without pelvic floor disorders up to 5 years postpartum (inclusion criteria). Validated instruments were employed to assess incontinence (ICIQ-SF) and sexual functioning (PISQ-IR: Condition Impact). The questions on the use of services and preventive measures, as well as on the interaction with a gynecologist, were based on self-developed items. RESULTS: In total, 49.4% of the participants of the survey showed symptoms of urinary incontinence (UI). Furthermore, only 40.3% (n = 241) of women were actively asked by their gynecologists for the occurrence of UI or PFD among those who suffered from PFD. Overall, 79.3% of the participants of the survey with UI underwent measures to deal with the complaints. The ICIQ-SF Score was significantly associated with all self-induced measures. High School diplomas and academic degrees were associated with the use of love balls (p < 0.05). CONCLUSION: The results of the study show the unmet needs of postpartum women. PFD should be addressed more frequently in the outpatient setting. Furthermore, more systematic information about the treatment of PFD could help to address unmet information needs and improve interventions.

Expanded nursing roles to promote person-centred care for people with cognitive impairment in acute care (ENROLE-acute): study protocol for a controlled clinical trial, process and economic evaluation.

BACKGROUND: For people with cognitive impairment, hospitalisation is challenging and associated with adverse events as well as negative outcomes resulting in a prolonged hospital stay. Person-centred care can improve the quality of care and the experience of people with cognitive impairment during hospitalisation. However, current care processes in German hospitals are rarely person-centred. To enable successful implementation of person-centred care on hospital wards, change agents within the interprofessional team are key. The aim of this study is to test the feasibility and initial effects of a newly developed complex person-centred care intervention for people with cognitive impairment provided by expanded practice nurses in acute care. METHODS: We will conduct an exploratory non-randomised controlled clinical trial with accompanying process and cost evaluation with three intervention and three control wards at one university hospital. The person-centred care intervention consists of 14 components reflecting the activities of expanded practice nurses within the interprofessional team on the intervention wards. The intervention will be implemented over a six-month period and compared with optimised care on the control wards. We will include people aged 65 years and older with existing cognitive impairment and/or at risk of delirium. The estimated sample size is 720 participants. The primary outcome is length of hospital stay. Secondary outcomes include prevalence of delirium, prevalence of agitation, sleep quality, and person-centred care. We will collect patient level data at six time points (t1 admission, t2 day 3, t3 day 7, t4 day 14, t5 discharge, t6 30 days after discharge). For secondary outcomes at staff level, we will collect data before and after the intervention period. The process evaluation will examine degree and quality of implementation, mechanisms of change, and the context of the complex intervention. The economic evaluation will focus on costs from the hospital's perspective. DISCUSSION: The ENROLE-acute study will provide insights into the effectiveness and underlying processes of a person-centred care intervention for people with cognitive impairment provided by expanded practice nurses on acute hospitals wards. Results may contribute to intervention refinement and evidence-based decision making. TRIAL REGISTRATION: Current controlled trials: ISRCTN81391868. Date of registration: 12/06/2023. URL: https://doi.org/10.1186/ISRCTN81391868.

How does stress affect maternal and paternal perceptions of relationship strain after a preterm birth? Results of a retrospective survey study.

AIM: Strain on couple relationships is associated with a lower well-being. As premature birth is known to pose stress to parents, this study explores whether interparental relationship strain comes to pass within mothers and fathers during their infant's stay in a neonatal intensive care unit. METHODS: A retrospective cross-sectional survey was conducted with parents who experienced a preterm birth (September to December 2020). Linear regression was used to analyse associations between stress and relationship strain. RESULTS: The study included 437 mothers and 301 fathers. Fathers experienced lower relationship strain (M = 2.49, SD = 1.00) than mothers (M = 3.37, SD = 1.04). Overall, a significant association between relationship strain and stress due to the infant's behaviour and appearance was found for mothers (ß = 0.16, p = 0.02) and fathers, with a significantly higher association for fathers (ß = 0.27, p ≤ 0.002). With regard to parental role alterations, only mothers showed a significant association (ß = 0.21, p ≤ 0.001). CONCLUSION: Although mothers showed higher levels of stress and relationship strain, stress may also have an impact on fathers. Therefore, research should focus on stress prevention measures to meet both maternal and paternal needs.

Factors associated with the closure of obstetric units in German hospitals and its effects on accessibility.

BACKGROUND: An increase in regionalization of obstetric services is being observed worldwide. This study investigated factors associated with the closure of obstetric units in hospitals in Germany and aimed to examine the effect of obstetric unit closure on accessibility of obstetric care. METHODS: Secondary data of all German hospital sites with an obstetrics department were analyzed for 2014 and 2019. Backward stepwise regression was performed to identify factors associated with obstetrics department closure. Subsequently, the driving times to a hospital site with an obstetrics department were mapped, and different scenarios resulting from further regionalization were modelled. RESULTS: Of 747 hospital sites with an obstetrics department in 2014, 85 obstetrics departments closed down by 2019. The annual number of live births in a hospital site (OR = 0.995; 95% CI = 0.993-0.996), the minimal travel time between two hospital sites with an obstetrics department (OR = 0.95; 95% CI = 0.915-0.985), the availability of a pediatrics department (OR = 0.357; 95% CI = 0.126-0.863), and population density (low vs. medium OR = 0.24; 95% CI = 0.09-0.648, low vs. high OR = 0.251; 95% CI = 0.077-0.822) were observed to be factors significantly associated with the closure of obstetrics departments. Areas in which driving times to the next hospital site with an obstetrics department exceeded the 30 and 40 min threshold slightly increased from 2014 to 2019. Scenarios in which only hospital sites with a pediatrics department or hospital sites with an annual birth volume of ≥ 600 were considered resulted in large areas in which the driving times would exceed the 30 and 40 min threshold. CONCLUSION: Close distances between hospital sites and the absence of a pediatrics department at the hospital site associate with the closure of obstetrics departments. Despite the closures, good accessibility is maintained for most areas in Germany. Although regionalization may ensure high-quality care and efficiency, further regionalization in obstetrics will have an impact on accessibility.

Gynaecologists' perceptions of outpatient gynaecologic and obstetric care in Germany during the COVID-19 pandemic.

The measures taken to contain the COVID-19 pandemic had a major impact on society, affecting medical care as well as the utilization of medical services. We aimed to identify pandemic-related changes in gynaecologic/obstetric care through the personal experience of practitioners in the outpatient sector in Germany. Three consecutive anonymous online surveys of practising gynaecologists were conducted during the pandemic (07-09/2020, 11-12/2020 and 09-11/2021). Appointment management, medical supply and patients' demand as well as concomitant circumstances were queried. Data from 860 (393, 262 and 205 from the first, second and third surveys, respectively) respondents were analysed. At the peak of the first COVID-19 wave, more than 50% of the gynaecologists surveyed had cancelled cancer screening appointments. There was a significant association between fear of self-infection and cancellation of cancer screening appointments (p = 0.006). An increase in domestic violence was reported by 13%, an increase in obesity by 67% and more advanced tumours due to delayed screening by 24% of respondents. Primary gynaecological oncological prevention was reduced in supply and demand during the COVID-19 pandemic, and this shortfall should be addressed in future similar situations. Prenatal care has been offered continuously since the start of the pandemic in Germany.

[Research Data Center on Health - Vision for Further Development from the Research Perspective]. / Forschungsdatenzentrum Gesundheit ­ Vision für eine Weiterentwicklung aus Sicht der Forschung.

The German research data center for health will provide claims data of statutory health insurances. The data center was set up at the medical regulatory body BfArM pursuant to the German data transparency regulation (DaTraV). The data provided by the center will cover about 90% of the German population, supporting research on healthcare issues, including questions of care supply, demand and the (mis-)match of both. These data support the development of recommendations for evidence-based healthcare. The legal framework for the center (including §§ 303a-f of Book V of the Social Security Code and two subsequent ordinances) leaves a considerable degree of freedom when it comes to organisational and procedural aspects of the center's operation. The present paper addresses these degrees of freedom. From the point of view of researchers, ten statements show the potential of the data center and provide ideas for its further and sustainable development.

Evolution of advanced practice nursing in acute care in Germany: A cross-sectional study of nurses' scope of practice.

AIM: To describe activities and professional characteristics of nurses in expanded roles in acute care in Germany and achieve a greater understanding of the current situation of advanced practice nursing. BACKGROUND: Advanced practice nursing plays an important role in meeting increased demands in healthcare and promoting high-quality care. INTRODUCTION: In Germany, advanced practice nursing is still at an early stage with a lack of studies describing the scope of practice of nurses in expanded roles. METHODS: We conducted a cross-sectional-study using a paper-and-pencil questionnaire. In a nationwide convenience sample, we surveyed nurses with an academic degree, who work in an acute care hospital and take over expanded roles in direct patient care. Reporting followed the STROBE checklist. RESULTS: Of 108 eligible nurses, 84 (77%) completed the survey. The majority had a Master's degree (63.1%) and the average work experience was 18.2 years. Participants carried out activities in all the domains that were queried (direct clinical practice, guidance and coaching, consultation, leadership and research) with differences within and between domains. Foci were on direct clinical practice and coaching and guidance. DISCUSSION: In Germany, qualifications are nearing the international standard of advanced practice nursing. Results suggest that participants partly undertake activities within the scope of registered nurses' practice that do not correspond fully to their formal qualifications. CONCLUSION AND IMPLICATIONS FOR NURSING AND/OR HEALTH POLICY: In order to foster the role development of expanded practice nurses in Germany, political efforts are needed in terms of training (e.g. specific Master's programmes), funding of corresponding positions in practice and control mechanisms (e.g. professional registration).

Work climate in pandemic times: which burdens do German physicians in primary care report?

BACKGROUND: In Germany, general practitioners (GPs) provide basic and primary care in the ambulatory sector and refer patients to other specialists when necessary. Often, GPs present the first point of contact for patients in the German healthcare system. During the COVID-19 pandemic, GPs and other medical specialists in the ambulatory setting suddenly were confronted with unprecedented challenges. OBJECTIVE: To answer the following research questions: How did COVID-19-related challenges affect the work climate? Do physicians with deteriorated work climate simultaneously report a worsened provision of patient care? Which challenges were the most burdening? METHODS: In the course of the project COVID-GAMS more than 18 000 physicians of various specialties had been invited to a quantitative cross-sectional online survey (in Summer 2020). Analyses were conducted separately for the groups of GPs and other medical specialists. Group differences were analysed statistically and burdening factors were identified. RESULTS: 1703 participants were included in the analysis. 22.2% of GPs (other medical specialists: 19.9%) stated, their work climate had deteriorated. Physicians with a deteriorated work climate showed a tendency towards poorer personal provision of patient care (M = 3.75, SD = 0.98 versus M = 3.93, SD = 0.99) compared to unchanged or improved work climate. The lack of protective material in March/April 2020, changes in practice management and possible economic impacts on the practice were the most burdening factors reported by GPs. CONCLUSION: GPs who reported a negative impact on the work climate in the course of the first pandemic lockdown also tend to see own deficits in the provision of patient care.

The psychological consequences of living with coronary heart disease: Are patients' psychological needs served? A mixed-method study in Germany.

INTRODUCTION: This mixed-method study explores psychological needs, access and barriers in coronary heart disease (CHD) patients with and without mental health issues (MHI) within the German healthcare system. METHODS: This study was conducted in three different healthcare settings: two hospitals, two rehabilitation clinics and three cardiology practices in Cologne, Germany. Patients were screened for angiographically documented CHD and other inclusion criteria. In total, 364 CHD patients took part in this study. It consisted of two parts: In the first part, participants filled in a newly developed questionnaire about their psychological needs, access and barriers within the healthcare system and their contact with their doctor in these matters. Then, patients were screened for MHIs with the help of the Hospital Anxiety and Depression Scale (HADS). When a score above seven was scored on the HADS, patients were additionally screened for specific MHIs using the Structured Clinical Interview for DSM-IV Axis I Disorders. In the second part, 20 participants were subsequently interviewed in a semi-structured interview to generate more in-depth findings. RESULTS: The interviews show that CHD patients with and without MHI experienced a cardiac event as life-changing and had an urgent need to talk about CHD with their doctor, mostly the general practitioner (GP). When the GP spoke to the patient shortly after the cardiac event, patients experienced relief and were better able to cope with their illness. Only 9.1% reported being aided in their search for psychotherapeutic treatment or drug treatment (4.1%). CONCLUSION: The needs of CHD patients with and without MHI were not adequately satisfied within our sample. Psychological measures are necessary for sufficient improvement, such as training of doctors in doctor-patient communication (e.g., better support in coping with MHI/CHD), improvements in the procedure (more time for conversations during doctor contacts), and improvement of structural requirements (referring patients faster to psychotherapists). PATIENT OR PUBLIC CONTRIBUTION: We received input from patients during pretests and used the feedback to tailor our questionnaire and the interview guidelines. Afterwards, we disseminated the main results for the patient and public involvement (e.g., public lectures, leaflets for self-help groups, etc.).

Parental preference for webcams in neonatal intensive care units: an indicator of lacking trust?

BACKGROUND: Some neonatal intensive care units offer parents webcam systems for times when they cannot be in the ward. Leaving an infant in the ward can be challenging for parents, and trust in the neonatal healthcare professionals mitigates parents' worries of not knowing how their infant is doing while they are away. If parents lack trust in the neonatal healthcare professionals, they may attempt to compensate by using webcams. In this work, we examine whether an association exists between the parental preference to use a webcam and low trust in physicians and nursing staff. METHODS: In a nationwide, retrospective cross-sectional study, parents of infants with a birth weight below 1500 g were surveyed six to 18 months after their infant's birth. Parents who were not offered a webcam system in the ward were asked whether they would have opted for it. Trust was measured by the Trust in Physician and Trust in Nursing Staff scales. RESULTS: Of the parents who were not offered a webcam, 69% would have chosen to use a webcam if they had been granted the opportunity. The decision for or against a webcam was not significantly associated with either trust in physicians (OR = 0.654, 95% CI = 0.456, 0.937, p = .124) or trust in nursing staff (OR = 1.064, 95% CI = 0.783, 1.446, p = .932). CONCLUSIONS: While the majority of parents surveyed would opt for webcam usage, this preference should not be interpreted as an indicator of lacking trust in neonatal healthcare professionals.

Trust in medical professionals and its influence on the stress experience of parents of premature infants.

AIM: To examine parents' perceptions of stress and their trust in physicians and nursing staff and to investigate whether trust influences the parental perceptions of potential stressors resulting from their infant's hospitalisation in a neonatal intensive care unit. METHODS: Parents of very and extremely low birth weight infants were surveyed in a nationwide retrospective cross-sectional study 6-18 months after their child's birth. Parental stress was measured utilising the PSS:NICU_German/2-scales, and trust was measured by the scales Trust in Physicians and Trust in Nursing Staff. In addition to descriptive analyses, multiple linear regression models were conducted. RESULTS: The change in parents' anticipated roles was assessed as more stressful than their infant's appearance and behaviour. Trust in nursing staff significantly influenced the parental stress level. Although the level of trust in physicians was rated higher than trust in nursing staff, trust in physicians did not yield a significant effect on the parental stress experience. CONCLUSION: Efforts to foster parental trust in nursing staff may reduce the parental stress level and hence enable parents to better cope with the situation. The parental resources unleashed in this way can be employed to enhance parenting.

Driving new technologies in hospitals: association of organizational and personal factors with the readiness of neonatal intensive care unit staff toward webcam implementation.

BACKGROUND: The use of webcam technology in neonatal intensive care units (NICUs) enables parents to see their child when the parents cannot be present at the NICU. The webcam's use has been gaining increasing attention. Lead physicians and lead nursing staff play a key role in the decision of whether to implement webcams. This study investigates factors that are associated with the readiness for the implementation of a webcam system among lead NICU staff. METHODS: A postal survey was conducted among all lead physicians and lead nursing staff in all German NICUs between December 2020 and April 2021 (total N = 416, one lead physician and one lead nursing staff per NICU, N = 208). On the basis of normalization process theory, personal (technology acceptance) and organizational (innovation climate) attributes were chosen to determine their association with the readiness for the implementation of a webcam system. The association of these factors was determined using multiple linear regression models for both lead physicians and lead nurses. RESULTS: Overall, a response rate of 66.59% (n = 277) was achieved. Technology acceptance proved to be a significant factor associated with the readiness for the implementation of a webcam system among lead physicians. Furthermore, staff already working with webcams in their NICUs indicated a significantly higher level of technology acceptance than staff without webcam experience and without any desire to use a webcam in the future. No significant association was found between innovation climate and the readiness for the implementation of a webcam system. CONCLUSIONS: Technology acceptance was identified as a factor associated with the readiness for the implementation of a webcam system. The insights from this study can be used to manage potential barriers regarding the readiness for implementation of webcams in NICUs. TRIAL REGISTRATION: The Neo-CamCare study is registered at the German Clinical Trials Register. DRKS-ID: DRKS00017755 . Date of Registration in DRKS: 25-09-2019.

Conducting a prospective evaluation of the development of a complex psycho-oncological care programme (isPO) in Germany.

BACKGROUND: Evaluating the development phase of a complex intervention programme can be challenging. A prospective evaluation approach is presented based on the example of the new complex psycho-oncological care programme isPO (integrated, cross-sectoral Psycho-Oncology). Prior to programme implementation, we examined (1) if isPO was developed as intended, and (2) if it was relevant and transferable into the newly developed psycho-oncological care networks in North-Rhine Westphalia, Germany. Further, we investigated which implementation facilitators and barriers were anticipated and which implementation strategies were planned by the programme designers (multidisciplinary professionals and cancer supporting organizations who developed the isPO programme components and the networks). METHODS: A mixed-methods approach was applied. Qualitative data were collected by quarterly progress reports, interviews and a focus group with the programme designers. Evaluation criteria for document analyses of the quarterly progress reports were developed and applied. Content analysis was applied for analysing interviews and focus group. Quantitative data were gained from evaluating the programme training for the isPO service providers by short written questionnaires that were analysed descriptively. RESULTS: An implementable prototype of the isPO programme has been developed within 15 months, however no piloting was conducted. The programme's complexity proved to be challenging with regard to coordination and communication of the numerous programme designers. This was intensified by existing interdependencies between the designers. Further, there was little communication and participation between the programme designers and the prospective users (patients and service providers). Due to these challenges, only context-unspecific implementation strategies were planned. CONCLUSION: The required resources for developing a new complex care programme and the need of a mature implementation strategy should be sufficiently addressed. Programmes may benefit from prospective evaluation by gaining insightful knowledge concerning the programme's maturity and anticipating implementation facilitators and barriers. A mixed-methods evaluation design was crucial for achieving profound insight into the development process. TRIAL REGISTRATION: The study has been registered in the German Clinical Trials Register (No. DRKS00015326 ) on 30.10.2018.

Mental disorders and utilization of mental health services in newly diagnosed cancer patients: An analysis of German health insurance claims data.

OBJECTIVE: People with cancer are often confronted not only with the burdens of medical treatment but also with psychological strain, which can lead to mental disorders (MD). To date, the prevalence of MD in newly diagnosed cancer patients and their utilization of mental health services (MHS) are mainly estimated through data of primary studies than considering healthcare-related claims data. METHODS: Statutory health insurance claims data of the AOK/KV Hesse from 2011 to 2014 was analyzed. The number of incident cancer patients with MD and the utilization of MHS within the period of the quarter of incident cancer diagnosis and three subsequent quarters were determined. For incident cancer patients with an incident MD, the predictive values of sex, age group, and tumor entity on the documentation of MD diagnosis and utilization were investigated. RESULTS: The 12-month prevalence of MD in incident cancer patients was 31.1% for depression, 11.2% for anxiety disorders, and 9.2% for post-traumatic stress/adjustment disorder (PTSD/AD). Of these, 65.9% received outpatient psychotherapy and 43.0% at least one psychopharmacological drug prescription. Men had a significantly lower chance of receiving an MD diagnosis following cancer. CONCLUSIONS: The prevalence of MD observed was higher for depression and lower for PTSD/AD compared to meta-analyses of clinical trials. Male cancer patients had a lower chance of receiving an MD diagnosis than females, which coincides with existing results.

The role of personal attitudes of control and responsibility for the uptake of peritoneal dialysis- a national survey among dialysis patients.

BACKGROUND: Although most patients are suitable for both hemodialysis (HD) and peritoneal dialysis (PD), there seem to be differences in the outlook of patients who choose one modality over the other. There is currently limited literature about the impact of patients' personal attitudes on the decision for PD or HD. In this study, we tried to find out whether there were differences between patients who were on HD and PD in their desire for control and responsibility for their treatment. METHODS: The data were drawn from a nationwide postal survey of 630 HD and PD patients. Patients' desire for control was measured by scores on the internal locus of control (ILOC) scale. Patients were also asked how important taking responsibility for their dialysis had been for their treatment decision (ITR). Two multivariate logistic regression models, both adjusted for age, were applied to investigate whether there were differences between HD and PD patients in ILOC and ITR. Having one generic measure (ILOC) and one tailored to the dialysis context (ITR) gave the opportunity to investigate if it is a generic personality trait or rather a specific attitude that affects choice of dialysis modality. RESULTS: PD patients were younger and showed higher ILOC and ITR values. Multivariate logistic regression models adjusted for age confirmed the significant influence of ILOC and ITR on the uptake of PD. The odds ratios for being in the PD group were 1.53 for ILOC (p = 0.030; 95% CI 1.04-2.25), 1.49 for ITR (p = 0.019; 95% CI 1.07-2.07), and 0.95 (p = 0.000; 95% CI 0.94-0.97) for age in both models. CONCLUSIONS: Our analysis shows the impact of personal attitudes on the uptake of PD. Participants who generally want to keep control of their lives and take responsibility for their dialysis treatment tended to choose PD. As PD is a home dialysis treatment that requires patients to participate and contribute, it is beneficial if patients' personalities support the treatment procedure. Having two completely different treatment options that suit to different personalities gives us the opportunity to consider the relationship between personal attitudes and choice of dialysis modality. TRIAL REGISTRATION: The MAU-PD study is registered at the German Clinical Trials Register. DRKS-ID: DRKS00012555 . Date of Registration in DRKS: 2018/01/04.