Effectiveness of motivational interviewing on medication adherence for the prevention of recurrent stroke or transient ischemic attack: Systematic review of randomized controlled trials.

BACKGROUND AND PURPOSE: This systematic review examines the effectiveness of motivational interviewing (MI) on medication adherence for preventing recurrent stroke and transient ischemic attack (TIA). METHODS: MEDLINE (via PubMed), CINAHL, PsycINFO, CENTRAL, and ClinicalTrials.gov were searched from inception to 12 June 2023. Randomized controlled trials comparing MI with usual care or interventions without MI in participants with any stroke type were identified and summarized descriptively. Primary outcome was medication adherence. Secondary outcomes were quality of life (QoL) and different clinical outcomes. We assessed risk of bias with RoB 2 (revised Cochrane risk-of-bias tool) and intervention complexity with the iCAT_SR (intervention Complexity Assessment Tool for Systematic Reviews). RESULTS: We screened 691 records for eligibility and included four studies published in five articles. The studies included a total of 2751 participants, and three were multicentric. Three studies had a high risk of bias, and interventions varied in complexity. Two studies found significantly improved medication adherence, one at 9 (96.9% vs. 88.2%, risk ratio = 1.098, 95% confidence interval = 1.03-1.17) and one at 12 months (97.0% vs. 95.0%, p = 0.026), but not at other time points, whereas two other studies reported no significant changes. No significant differences were found in QoL or clinical outcomes. CONCLUSIONS: Evidence on MI appears inconclusive for improving medication adherence for recurrent stroke and TIA prevention, with no benefits on QoL and clinical outcomes. There is a need for robustly designed studies and process evaluations of MI as a complex intervention for people with stroke. REGISTRATION: PROSPERO (CRD42023433284).

Use of indwelling urinary catheters in nursing home residents: results from a cross-sectional study in 21 German nursing homes.

BACKGROUND: Indwelling urinary catheters often lead to complications such as symptomatic urinary tract infections. In nursing home residents, catheter prevalence is high, but prevalence differences by sociodemographic characteristics, comorbidities, and health services use have rarely been investigated. The purpose of this work was to describe the use of indwelling urinary catheters in nursing home residents and to examine whether catheter use is associated with individual characteristics. METHODS: Cross-sectional data of the "Inappropriate Medication in patients with REnal insufficiency in Nursing homes" (IMREN) study conducted in 21 German nursing homes between October 2014 and April 2015 were analyzed. For all residents of the involved care units, nurses of the participating institutions completed an anonymous questionnaire including the Modified Rankin Scale to assess physical impairments. The proportion of nursing home residents with indwelling urinary catheter was determined. Associations between catheter use and individual characteristics were investigated via cluster-adjusted multivariable logistic regression. RESULTS: Of 852 residents (76.5% female; mean age 83.5 years), 13.4% had an indwelling urinary catheter. The adjusted odds ratios for catheter use for men vs. women was 2.86 (95% confidence interval 1.82-4.50). For residents with "moderate" disability vs. those with "no to slight" disability it was 3.27 (1.36-7.85), for individuals with "moderately severe" disability vs. the reference group it was 9.03 (3.40-23.97), and for those with "severe" disability vs. the reference group it was 26.73 (8.60-83.14). For residents who had been hospitalized within the last 12 months vs. those without a hospitalization it was 1.97 (1.01-3.87). For age, dementia, overweight/obesity, other indwelling devices, and long-term medications no significant associations were found. CONCLUSIONS: Male nursing home residents, residents with a higher degree of physical impairment, and those who had been hospitalized within the last 12 months were more likely to use an indwelling urinary catheter than their counterparts. Data on circumstances of and indications for catheters, catheter types, and duration of catheterization are needed to evaluate the appropriateness of catheter use in nursing home residents and the need for interventions.

Measuring patients' medical treatment preferences in advance care planning: development and validation of the Treat-Me-ACP instrument - a secondary analysis of a cluster-randomized controlled trial.

BACKGROUND: Advance Care Planning interventions should be evaluated as broadly as possible to gain a holistic understanding of the Advance Care Planning process. However, validated early stage outcome instruments are lacking. Therefore, the Treatment-Preference-Measure-Advance Care Planning (Treat-Me-ACP) instrument was developed and validated as part of the cluster-randomized controlled trial STADPLAN (Study on Advance Care Planning in care-dependent community-dwelling older persons) to assess the effects of Advance Care Planning interventions on patients' medical treatment preferences. METHODS: The design of Treat-Me-ACP is based on the Emanuel Medical Directive and the Life Support Preferences Questionnaires. Using a multi-stage team approach a preliminary version of the Treat-Me-ACP was developed and pre-tested. The pre-tested instrument consists of one global medical care goal-item, five hypothetical scenarios with five hypothetical treatments, and one how would you feel-item within each scenario. A total of five scenario preference scores and five treatment preference scores can be formed. This version was subsequently applied to a subsample of the STADPLAN project (n = 80) to assess patient's preferences at baseline (T0) and at 12-month follow-up (T2). The further validation steps were based on this subsample and included: (1) acceptance by using completion rate and frequencies of missing data, (2) internal consistency by using Cronbach's α to test whether it was possible to create preference scores by scenario and treatment, (3) concurrent validation examining the association between the global medical care goal-item and the preference scores and the association between the how would you feel-items and the scenario preference scores, and (4) responsiveness of the instrument to changes in preferences for life-sustaining treatments by comparing preference scores from T0 to T2 between study groups. RESULTS: Acceptance of the instrument was high. Results of concurrent validation indicate that the five scenarios represent the global medical care goal well. The preference scores showed an average tendency for decreasing preferences for life-sustaining treatments across all scales for the intervention group during study follow-up. CONCLUSIONS: The Treat-Me-ACP can be used to evaluate the dynamics of patients' medical treatment preferences in Advance Care Planning. It has been validated for care-dependent community-dwelling older persons and can be used as an additional outcome measure in evaluating the effectiveness of ACP interventions. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00016886 on 04/06/2019.

Abuse, dependence and withdrawal associated with fentanyl and the role of its (designated) route of administration: an analysis of spontaneous reports from Europe.

PURPOSE: Fentanyl, a highly potent synthetic opioid used in cancer and non-cancer pain, is approved for various routes of administration. In Europe, fentanyl consumption increased substantially in the last decades but information on abuse, dependence and withdrawal associated with fentanyl is scarce, especially with respect to its different formulations. METHODS: We analysed case characteristics of spontaneous reports of suspected fentanyl-associated abuse, dependence or withdrawal from European countries recorded in the EudraVigilance database up to 2018 with respect to the (designated) routes of administration and potential indications. RESULTS: A total of 985 reports were included (mainly from France and Germany) with 43% of cases referring to transdermal fentanyl. Median age was 45 years (48.8% female) and 21.6% had musculoskeletal disorders. Only 12.6% of those using transdermal fentanyl had a cancer diagnosis compared to 40.2% and 26.8% of those using intranasal and oral transmucosal fentanyl, respectively. Depression was common (10.7%) and highest in cases with musculoskeletal disorders (24.9%) as was the use of benzodiazepines. Overall, 39.5% of reports resulted in a prolonged hospital stay and for 23.2% a fatal outcome was recorded. The respective proportions were especially high in cases with musculoskeletal disorders (56.3% with prolonged hospitalisation) and in those using transdermal fentanyl (35.2% fatalities). CONCLUSIONS: In suspected cases of abuse, dependence or withdrawal, fentanyl was mainly used for non-cancer pain indications and most often as transdermal formulations. Depression and prolonged hospitalisations were common, especially in patients with musculoskeletal disorders, indicating a vulnerable patient group and complex treatment situations.

Identification of rheumatoid arthritis in German claims data using different algorithms: Validation by cross-sectional patient-reported survey data.

OBJECTIVE: To evaluate different algorithms for the identification of rheumatoid arthritis (RA) in claims data using patient-reported diagnosis as reference. METHODS: Within longitudinal data from a large German statutory health insurance, we selected a random sample of persons with ICD-10 code for RA (M05/M06) in ≥2 quarters in 2013. The sample was stratified for age, sex, and M05/M06. Persons were asked to confirm RA diagnosis (gold standard), which was linked to claims data given consent. Analyses were weighted to represent the total RA population of the database. Positive predictive values (PPVs) and discriminative properties were calculated for different algorithms: ICD-10 code only, additional examination of inflammatory markers, prescription of specific medication, rheumatologist appointment, or combination of these. RESULTS: Of 6193 persons with a claims diagnosis of RA, 3184 responded (51%). Overall, PPV for the ICD-10 code was 81% (95% confidence interval 79%-83%) with 94% (92%-95%) for M05 and 76% (73%-79%) for M06. PPVs increased (with loss of case numbers) if inflammatory markers (82% [80%-84%]), rheumatology visits (85% [82%-87%]) or specific medication (89% [87%-91%]) had been used in addition. Specific medication had the best discriminative properties (diagnostic odds ratio of 3.0) among persons with RA diagnosis. CONCLUSIONS: The ICD-10 codes M05 and (less optimal) M06 have high PPVs and are valuable to identify RA in German claims data. Depending on the respective research question, researchers should use different criteria for identification of RA.

Effects of advance care planning in care dependent community-dwelling older persons (STADPLAN): A cluster-randomised controlled trial.

BACKGROUND: Most randomised controlled trials on advance care planning were conducted in people with advanced, life-limiting illnesses or in institutional settings. There are few studies on its effect in older people living in the community. AIM: To determine the effects of advance care planning in older community dwelling people. DESIGN: The STADPLAN study was a cluster-randomised trial with 12 months follow-up. The complex intervention comprised a 2-days training for nurse facilitators that delivered a formal advance care planning counselling and a written information brochure. Patients in the control group received optimised usual care, that is, provision of a short information brochure. SETTING/PARTICIPANTS: Home care services in three regions of Germany were randomised using concealed allocation. Care dependent clients of participating home care services, aged 60 years or older, and rated to have a life-expectancy of at least 4 weeks were included. Primary outcome was active participation in care at 12 months, assessed by blinded investigators using the Patient Activation Measure (PAM-13). RESULTS: Twenty-seven home care services and 380 patients took part. Three hundred seventy-three patients were included in the primary analysis (n = 206 in the intervention and n = 167 in the control group). There was no statistically significant difference between the intervention and control group with regard to the PAM-13 after 12 months (75.7 vs 78.4; p = 0.13). No differences in quality of life, anxiety and depression, advance care planning engagement, and in proportion of participants with advance directives were found between groups. CONCLUSIONS: The intervention showed no relevant effects on patient activation or quality of life in community dwelling older persons, possibly indicating the need for more tailored interventions. However, results are limited by a lack of statistical power. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00016886.

Implementation, barriers, and recommendations for further development of advance care planning for the last phase of life in nursing homes in Germany (Gut-Leben): protocol for a mixed-methods study.

BACKGROUND: Nursing home entry often marks the transition into the end-of-life. In 2018, Germany legally introduced reimbursement for advance care planning (ACP according to § 132 g SGB V) in nursing homes that applied for ACP approval to improve end-of-life care. The Gut-Leben project aims to evaluate the implementation and barriers of ACP in nursing homes in Germany, with a special focus on the federal state of Lower Saxony, and provide practical recommendations for further development of end-of-life care. METHODS: This mixed-methods study spreads across five work packages (WP) over a three-year period. WP 1 will explore the approval process, implementation, and barriers to ACP in nursing homes. Data will be collected through a national postal survey in a random sample of n = 600. WP 2 will explore whether documented ACP reports are applicable as a data source for research (expecting up to 500 available ACP reports). In WP 3a and 3b, data on the ACP process will be collected in n = 15 approved nursing homes in Lower Saxony over a 12-months period. For WP 3a and WP 3b, data on ACP conversations (n = 600) and on end-of-life care paths (n = 300) will be collected by facilitators and nurses of the respective nursing homes. In WP 4, residents' characteristics upon entry and changes in these characteristics over the length of stay are analyzed, utilizing claims data from the AOK Lower Saxony (expected sample of about 100,000 people entering nursing homes over a 10-years period). WP 5 connects, interprets, and reflects on the findings from WP 1-4 through focus groups and individual interviews with facilitators, nursing staff, residents, relatives, and care providers. Within a participatory approach, a practice advisory board will be set up existing of personal of nursing homes and will be closely involved in the whole research process. DISCUSSION: In summary, the Gut-Leben project provides insight into the implementation and barriers of ACP in nursing homes according to German legislation for the first time, including practitioners' and residents' perspectives. Insights will help the further development of ACP in Germany through practical recommendations based on quantitative and qualitative data.

[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.

[Routine Practice Data for Health Care Analyses: Part 3 of the Manual]. / Versorgungsnahe Daten für Versorgungsanalysen ­ Teil 3 des Manuals.

Analyses of health and health care (hereafter referred to as "health care analyses") usually aim to make transparent the structures, processes, results and interrelationships of health care and to record the degree to which health care systems and their actors have achieved their goals. Health care-related data are an indispensable source of data for many health care analyses. A prerequisite for the examination of a degree of goal achievement is first of all an agreement on those goals that are to be achieved by the system and its substructures, as well as the identification of the determinants of the achievement of the objectives. Primarily it must be examined how safely, effectively and patient-centred systems, facilities and service providers are operating. It also addresses issues of need, accessibility, utilisation, timeliness, appropriateness, patient safety, coordination, continuity, and health economic efficiency and equity of health care. The results of health care include system services (outputs), on the one hand, and results (outcomes), on the other, whereby the results (patient-reported outcomes) and experiences (patient-reported experiences) reported are of particular importance. Health care analyses answer basic questions of health care research: who does what, when, how, why and with which resources and effects in routine health care. Health care analyses thus provide the necessary findings and key figures to further develop health care in order to improve the quality of health care. The applications range from capacity analyses to following innovations up to the concept of regional and supra-regional monitoring of the quality of care given to the population. Given the progress of digitalisation in Health Care, direct data from the care processes will be increasingly available for health care research. This can support care givers significantly if the findings of the studies are applied precisely and correctly within an adequate methodological frame. This can lead to measurable improved health care quality for patients. Data from the process of health care provision have a high potential. Their use needs the same scientific scrutiny as in all other scientific studies.

Restrictions and their reporting in systematic reviews of effectiveness: an observational study.

BACKGROUND: Restrictions in systematic reviews (SRs) can lead to bias and may affect conclusions. Therefore, it is important to report whether and which restrictions were used. This study aims to examine the use of restrictions regarding language, publication period, and study type, as well as the transparency of reporting in SRs of effectiveness. METHODS: A retrospective observational study was conducted with a random sample of 535 SRs of effectiveness indexed in PubMed between 2000 and 2019. The use of restrictions and their reporting were analysed using descriptive statistics. RESULTS: Of the total 535 SRs included, four out of every ten (41.3%) lacked information on at least one of the three restrictions considered (language, publication period, or study type). Overall, 14.6% of SRs did not provide information on restrictions regarding publication period, 19.1% regarding study type, and 18.3% regarding language. Of all included SRs, language was restricted in 46.4%, and in more than half of the SRs with restricted language (130/248), it was unclear whether the restriction was applied during either the search or the screening process, or both. The restrictions were justified for publication period in 22.2% of the respective SRs (33/149), study type in 6.5% (28/433), and language in 3.2% (8/248). Differences in reporting were found between countries as well as between Cochrane and non-Cochrane reviews. CONCLUSIONS: This study suggests that there is a lack of transparency in reporting on restrictions in SRs. Authors as well as editors and reviewers should be encouraged to improve the reporting and justification of restrictions to increase the transparency of SRs.

Health-Related Quality of Life according to Renal Function: Results from a Nationwide Health Interview and Examination Survey.

BACKGROUND: Most studies on health-related quality of life (HRQoL) in chronic kidney disease (CKD) focus on patients with end-stage kidney disease although they represent a small proportion of patients with CKD. We aimed to analyze HRQoL according to glomerular filtration rate (GFR) categories in a population-based sample of adults living in Germany. METHODS: Data from the German health interview and examination survey conducted from 2008 to 2011 were used. Participants with valid interview and examination data aged 40-79 years were included (n = 5,159). Serum creatinine levels were used to calculate estimated GFR via the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. We classified kidney function in GFR categories according to the Kidney Disease Improving Global Outcomes Initiative (KDIGO) guidelines on CKD: G1 (high): ≥90 mL/min/1.73 m2, G2 (normal): 60-89 mL/min/1.73 m2, G3a (mildly decreased): 45-59 mL/min/1.73 m2, G3b (moderately decreased): 30-44 mL/min/1.73 m2, G4/5 (severely decreased/end-stage kidney disease): <30 mL/min/1.73 m2. HRQoL was evaluated with the Short Form Health Survey (SF-36). Different multivariate linear and logistic regression models were used to analyze the association of HRQoL with GFR categories. RESULTS: Overall, 5.9% had a GFR <60 mL/min/1.73 m2 (corresponding to categories G3a, G3b, and G4/5). Compared to category G2 linear regression showed a decline in physical HRQoL in categories G3a (-2.34, p = 0.004), G3b (-5.37, p = 0.009), and G4/5 (-4.82, p = 0.117). No decline in mental HRQoL was detected with increasing GFR categories. Categories G3a to G4/5 were significantly associated with a low perceived general state of health (G3a: odds ratio [OR] = 2.03, p = 0.001; G3b: OR = 3.01, p = 0.009; G4/5: OR = 8.70, p = 0.016) when compared to category G2. CONCLUSION: In a representative sample of adults living in Germany, both physical HRQoL and the perceived general state of health are already significantly reduced in category G3a.

Contextual factors influencing advance care planning in home care: process evaluation of the cluster-randomised controlled trial STADPLAN.

BACKGROUND: The STADPLAN study is a cluster-randomised controlled trial including 27 home care services in Germany. It assesses the effect of an advance care planning (ACP) intervention delivered by trained nurses to older care-dependent patients. Patients received two ACP conversations and an information brochure. Nurses were educated through a two-day programme and topic guides structuring the conversations. Objectives of the process evaluation were to determine: [1] whether the intervention was implemented as planned, [2] which change mechanisms were observed, [3] whether targeted process outcomes were achieved and [4] in which way contextual factors influenced the implementation process. METHODS: The process evaluation is based on a mixed methods approach following the recommendations of the UK-MRC framework for the development and evaluation of complex interventions. Qualitative and quantitative assessments were developed and analysed guided by a logic model comprising intervention, participants, mechanisms of change and context factors. The results of the main trial will be published elsewhere. RESULTS: Educational programme and topic guides were mostly implemented as planned and resulted in motivation, knowledge, and perceived competencies to facilitate ACP conversations in nurses. Deviances in the performance of ACP conversations indicated patients' varied individual needs, but also obstacles like reluctance of patients and caregivers to participate actively and time constraints of nurse facilitators. Patients and caregivers reported increased awareness of ACP, planning and other activities indicating that targeted process outcomes could be achieved. The relevance of multifaceted contextual factors acting as barriers or facilitators for the engagement in ACP interventions on the individual, organisational and macro level was evident. CONCLUSIONS: The process evaluation elicits obstacles and achievements of the ACP intervention. The logic model organised a plethora of mixed methods data into a holistic picture of multifaceted results. Nurses as ACP facilitators in home care can fulfil a crucial initiating role based on a trusting relationship with their patients. To support older care-dependent people's ACP engagement, access should be simplified. Furthermore, education for nurse facilitators and sufficient resources for service provision are needed. Independent of monetary reimbursement, healthcare providers must respect patients' choice for or against any ACP intervention. ETHICS AND TRIAL REGISTRATION: Approved by the Ethics Committees of Martin Luther University Halle-Wittenberg (Ref.-No. 2019-045), Carl von Ossietzky University Oldenburg (Ref.-No. 2019-024), and University of Lübeck (Ref.-No. 19-080). GERMAN CLINICAL TRIALS REGISTER: DRKS00016886. Registered retrospectively 04/06/2019, first participant included 29/05/2019.

Contacts with general practitioners, dentists, and medical specialists among nursing home residents: a cross-sectional study in 44 German nursing homes.

BACKGROUND: Nursing home residents have high medical care needs. Their medical care utilization is, however, lower compared to community-dwelling elderly and varies widely among nursing homes. This study quantified the utilization of general practitioners (GPs), dentists, and medical specialists among nursing homes and residents, and investigated whether dentist utilization is associated with individual and nursing home characteristics. METHODS: Forty-four nursing homes invited 2124 residents to participate in a cross-sectional study. For 10 medical specialties, data on contacts in nursing homes, practices, and by telephone in the last 12 months were assessed at individual and nursing home level. The proportion of nursing homes and residents with any form of contact, and the median number and interquartile range (IQR) of contacts among individuals with contact were determined. Using multilevel logistic regression, associations between the probability of individual dental care utilization and sex, age, LTC grade, years of residence, sponsorship, number of nursing home beds, and transport and medical escort services for consultations at a practice were investigated. RESULTS: The proportion of nursing homes with any form of contact with physicians ranged from 100% for GPs, dentists, and urologists to 76.7% for gynecologists and orthopedists. Among the nursing homes, 442 residents participated (20.8% response). The proportion of residents with any contact varied from 97.8% for GPs, 38.5% for neurologists/psychiatrists, and 32.3% for dentists to 3.0% for gynecologists. Only for GPs, neurologists/psychiatrists, dentists, otorhinolaryngologists, urologists, and dermatologists, the proportion was higher for nursing home contacts than for practice and telephone contacts. Among residents with any contact, the median number of contacts was highest for GPs (11.0 [IQR 7.0-16.0]), urologists (4.0 [IQR 2.0-7.0]), and neurologists/psychiatrists (3.0 [IQR 2.0-5.0]). Dentist utilization varied widely among nursing homes (median odds ratio 2.5) and was associated with higher age. CONCLUSIONS: Almost all residents had regular contact to GPs, but only one third had contact with dentists. Lower proportions with contact were found for medical specialists, except for neurologists/psychiatrists. Reasons for the large variations in dental care utilization among nursing homes should be identified. TRIAL REGISTRATION: DRKS00012383 [2017/12/06].

The influence of obesity on functional outcomes and patient satisfaction 8 weeks after total knee arthroplasty: results of the prospective FInGK study.

OBJECTIVES: To investigate obese versus non-obese subjects´ knee joint function, stiffness, pain, expectations, and outcome satisfaction before and two months after total knee arthroplasty (TKA). METHODS: This study is a secondary analysis of data retrieved via a prospective single-centre cohort study investigating knee joint function and health care services utilization in patients undergoing TKA (FInGK Study). For the primary study, elective TKA patients were consecutively recruited between December 2019 and May 2021. Preoperative expectations, Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC), surgery outcome satisfaction, and sociodemographic variables were assessed via self-reported questionnaires. In the current study, obese (Body Mass Index (BMI) ≥ 30 kg/m²) versus non-obese (BMI < 30 kg/m²) subjects' data were exploratively compared before and two months after TKA. Multivariable logistic regression assessed factors associated with TKA satisfaction two months postoperatively. Linear regression evaluated factors associated with higher WOMAC change two months postoperatively. RESULTS: A total of 241 subjects participated (response: 85.2%). Eighty-seven were non-obese (mean age: 70.7 years, 63.2% female) and 154 were obese (mean age: 67.1 years, 57.8% female). Obese subjects reported inferior pre- and postoperative pain and knee joint function compared to non-obese subjects. Yet, WOMAC scores of obese and non-obese subjects significantly improved from preoperative means of 52.6 and 46.8 to 32.3 and 24.4 after surgery, respectively. The only significant TKA satisfaction predictor was subjects' smoking status. Non-obesity and worse preoperative WOMAC scores were predictive of higher WOMAC change scores after two months. CONCLUSION: Both obese and non-obese subjects reported significant symptom improvements. However, as obese subjects' short-term outcomes were still inferior, more research on TKA rehabilitation measures adapted to the needs of this growing patient group is warranted to maximize their benefits from TKA.

Characteristics and place of death in home care recipients in Germany - an analysis of nationwide health insurance claims data.

BACKGROUND: Most care-dependent people live at home, where they also would prefer to die. Unfortunately, this wish is often not fulfilled. This study aims to investigate place of death of home care recipients, taking characteristics and changes in care settings into account. METHODS: We retrospectively analysed a cohort of all home-care receiving people of a German statutory health insurance who were at least 65 years and who deceased between January 2016 and June 2019. Next to the care need, duration of care, age, sex, and disease, care setting at death and place of death were considered. We examined the characteristics by place of care, the proportion of dying in hospital by care setting and characterised the deceased cohort stratified by their actual place of death. RESULTS: Of 46,207 care-dependent people initially receiving home care, 57.5% died within 3.5 years (n = 26,590; mean age: 86.8; 66.6% female). More than half of those moved to another care setting before death with long-term nursing home care (32.3%) and short-term nursing home care (11.7%) being the most frequent transitions, while 48.1% were still cared for at home. Overall, 36.9% died in hospital and in-hospital deaths were found most often in those still receiving home care (44.7%) as well as care in semi-residential arrangements (43.9%) at the time of death. People who died in hospital were younger (mean age: 85.5 years) and with lower care dependency (low care need: 28.2%) as in all other analysed care settings. CONCLUSION: In Germany, changes in care settings before death occur often. The proportion of in-hospital death is particularly high in the home setting and in semi-residential arrangements. These settings should be considered in interventions aiming to decrease the number of unwished care transitions and hospitalisations at the end of life.

[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.

[Nurses' perspectives on their potential role in advance care planning in home care: A qualitative study]. / Die Sichtweise von Pflegefachpersonen auf ihre mögliche Rolle bei Advance Care Planning in der ambulanten Pflege.

Nurses' perspectives on their potential role in advance care planning in home care: A qualitative study Abstract. Background: Advance Care Planning (ACP) in long-term care in Germany has been identified as a potential area of nurses' responsibility. In the StAdPlan study (DRKS0016886), an ACP intervention in outpatient care was implemented and evaluated: Trained nurses conducted ACP conversations with patients. A comprehensive process evaluation was part of the study. Aim: A partial result of the process evaluation was analysing the perspective of nurses on their potential role as ACP facilitators for outpatients. Methods: Semi-structured interviews with nursing professionals and nursing service managers (n = 42) were carried out prior to the implementation of the ACP intervention. A qualitative content analysis of the recorded interviews was performed. Results: Participants described the importance of ACP in outpatient care, their personal motivation and competence as well as necessary contextual conditions. Nursing professionals are motivated to offer ACP to patients to be able to care for them according to their wishes. For effective ACP conversations, nurse professionals considered in-depth knowledge of ACP, conversational skills and sufficient time resources as necessary. ACP consultations can be a suitable field of action for nurses as they have access and an established relationship of trust with patients. Conclusions: Under certain conditions, nurses' role in offering guidance on ACP in outpatient care was seen as feasible and beneficial. Prerequisites for implementation are financial resources and training for nurses for this service.

[Advance care planning conversations in home care: Intervention development with the Behaviour Change Wheel]. / Beratung zu Advance Care Planning in der ambulanten Pflege.

Advance care planning conversations in home care: Intervention development with the Behaviour Change Wheel Abstract. Background: StAdPlan is a multicenter, cluster-randomized controlled trial aimed to develop and evaluate an advance care planning (ACP) intervention for the German home care setting. Aim: This paper reports the intervention development. Available ACP concepts were reviewed and adapted to the German home care context in terms of staffing and available time resources. Skilled nurses are assigned to raise the awareness on ACP among older care-dependent people and their informal caregivers/relatives through structured conversation and facilitating the use of existing counselling services. Methods: The Behavior Change Wheel (BCW) was applied to the development of the intervention components. Results: The complex intervention addresses care-dependent people aged 65 years and above and their informal caregivers. A two-day training session qualifies nursing professionals to offer guideline-based conversations which take place at least twice at the care-dependent person's home, if possible with the involvement of relatives. An additional information brochure is provided. Conclusions: The application of the BCW model proved to be appropriate for the analysis, description and definition of the specific functions of the intervention. The intervention is prepared for the effectiveness study.

Treatment of post-prostatectomy urinary incontinence and erectile dysfunction: there is insufficient utilisation of care in German cancer survivors.

PURPOSE: Treatment of post-prostatectomy urinary incontinence (UI) and erectile dysfunction (ED) increases quality of life (QoL). Aim of our study was to evaluate the utilisation of care among patients with post-prostatectomy UI and ED in Germany. METHODS: The HAROW study documented treatment of patients with localised prostate cancer (≤ T2c) in Germany. 1260 patients underwent radical prostatectomy (RP). Patients answered validated questionnaires after a median follow-up of 6.3 years. Response rate was 76.8%. RESULTS: Median age at RP was 65 (IQR 60-69) years. 14% (134/936) used more than one pad per day for UI. 25% (26/104, 30 missing) of UI patients underwent surgery to improve continence. Of patients without surgery, 41% (31/75) reported a moderate-to-severe issue concerning their incontinence with worse mental health and QoL. 81% (755/936) patients were unable to have an erection firm enough for sexual intercourse. Of all ED patients, 40% (319/793) used ED treatment regularly or tried it at least once. 49% (243/499) of patients with interest in sex never tried ED treatment. In multivariate analysis, patients not using ED treatments were older (≥ 70 years OR 4.1), and more often had preoperative ED (OR 2.3) and less interest in sex (OR 2.2). Nevertheless, 30% (73/240) of these patients had moderate-to-severe issues with their ED reporting worse mental health and QoL. CONCLUSION: Almost half of the patients without post-prostatectomy UI and ED treatment reported moderate-to-severe issues with a significant decrease in QoL. This indicates an insufficient utilisation of care in Germany.

Global COVID-19 pandemic and reporting behavior - An analysis of the Food and Drug Administration adverse events reporting system.

PURPOSE: To describe the characteristics of adverse event reporting in the United States (US) Food and Drug Administration Adverse Event Reporting System (FAERS) before and after the outbreak of the COVID-19 pandemic. METHODS: We included all FAERS reports from the US and Canada from November 7, 2019 to July 15, 2020 and divided the study period into three equal time intervals (pre-pandemic, first pandemic, second pandemic). We focused on methotrexate, a broadly used drug unrelated to COVID-19, and (hydroxy)chloroquine, another broadly used drug implicated in COVID-19 treatment. Using descriptive statistics, we compared reporting characteristics before and after the COVID-19 outbreak. RESULTS: During the study period, 366 998 cases (60% female, median age: 59 years) were submitted to FAERS. The daily median number of reports (1796 in the pre-pandemic, 1810 in the second pandemic time interval) and other characteristics remained stable. The daily median number of reports for methotrexate decreased from 28 in the pre-pandemic to 15 in the second pandemic time interval, with no considerable differences in other characteristics. The daily median number of reports for (hydroxy)chloroquine increased slightly from 1 in the pre-pandemic to 3 in the second pandemic time interval, while there were also changes in the demographics of cases and an increase in the proportion of cases reported by health professionals. CONCLUSIONS: The overall reporting to FAERS did not change after the outbreak of the COVID-19 pandemic. However, some stimulated reporting was observed for (hydroxy)chloroquine, highlighting the need for caution when conducting pharmacovigilance analyses with substances related to COVID-19.