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.

End-of-life care in German and Dutch nursing homes: a cross-sectional study on nursing home staff's perspective in 2022.

BACKGROUND: As society ages, the need for nursing home care is steadily increasing and end-of-life care of nursing home residents has become increasingly more important. End-of-life care differs between Germany and the neighbouring Netherlands. For example, a much higher proportion of German compared to Dutch nursing home residents is hospitalized at the end of life. Therefore, the aim of this study was to evaluate end-of-life care in German and Dutch nursing homes. METHODS: In this cross-sectional study, a postal survey was sent to 600 randomly selected German and Dutch nursing homes each and addressed to the nursing staff management. Participants were asked to estimate the percentage of nursing home residents whose wishes for emergency situations (e.g. cardiopulmonary resuscitation) are known and to indicate whether facilities offer advanced care planning (ACP). They were also asked to estimate whether general practitioners (GPs)/elder care physicians (ECPs) and nursing home staff are usually well trained for end-of-life care. Finally, participants were asked to estimate the proportion of nursing home residents who die in hospital rather than in the nursing home and to rate overall end-of-life care provision. RESULTS: A total of 301 questionnaires were included in the analysis; 199 from German and 102 from Dutch nursing homes (response 33.2% and 17.0%). German participants estimated that 20.5% of residents die in the hospital in contrast to the Dutch estimation of 5.9%. In German nursing homes, ACP is offered less often (39.2% in Germany, 75.0% in the Netherlands) and significantly fewer wishes for emergency situations of residents were known than in Dutch nursing homes. GPs were considered less well-trained for end-of-life care in Germany. The most important measures to improve end-of-life care were comparable in both countries. CONCLUSION: Differences in (the delivery and knowledge of) end-of-life care between Germany and the Netherlands could be observed in this study. These could be due to structural differences (ECPs available 24/7 in the majority of Dutch nursing homes) and cultural differences (more discussion on quality of life versus life-sustaining treatments in the Netherlands). Due to these differences, a country-specific approach is necessary to improve end-of-life care.

Differences in emergency department visits and hospitalization between German and Dutch nursing home residents: a cross-national survey.

PURPOSE: Assessing and comparing German and Dutch nursing home perspectives on residents' hospital transfers. METHODS: Cross-sectional study among German and Dutch nursing homes. Two surveys were conducted in May 2022, each among 600 randomly selected nursing homes in Germany and the Netherlands. The questionnaires were identical for both countries. The responses were compared between the German and Dutch participants. RESULTS: We received 199 German (response: 33.2%) and 102 Dutch questionnaires (response: 17.0%). German nursing homes estimated the proportion of transfers to hospital during 1 year to be higher than in Dutch facilities (emergency department visits: 26.5% vs. 7.9%, p < 0.0001; hospital admissions: 29.5% vs. 10.5%, p < 0.0001). In German nursing homes, the proportion of transfers to hospital where the decision was made by the referring physician was lower than in the Dutch facilities (58.8% vs. 88.8%, p < 0.0001). More German nursing homes agreed that nursing home residents are transferred to the hospital too frequently (24.5% vs. 10.8%, p = 0.0069). German nursing homes were much more likely than Dutch facilities to believe that there was no alternative to transfer to a hospital when a nursing home resident had a fall (66.3% vs. 12.8%, p < 0.0001). CONCLUSION: German nursing home residents are transferred to hospital more frequently than Dutch residents. This can probably be explained by differences in the care provided in the facilities. Future studies should, therefore, look more closely at these two systems and examine the extent to which more intensive outpatient care can avoid transfers to hospital.

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).

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.

Comparison of medical care needs and actual care in German and Dutch nursing home residents: A cross-sectional study conducted in neighboring European countries.

OBJECTIVE: Assessing and comparing characteristics of German and Dutch nursing homes, their residents as well as residents' medical care needs and the actual provision of care. METHODS: Two surveys were conducted among 600 randomly selected nursing homes each from Germany and the Netherlands. Questionnaires were mailed in May 2022. Responses were compared between German and Dutch respondents. RESULTS: We received 199 German (response: 33.2%) and 102 Dutch questionnaires (response: 17.0%). Residents' characteristics were comparable in both countries. While German nursing homes rated residents' general medical care needs higher than Dutch facilities (87.9% vs. 78.4%), the reverse was true for dental care needs (81.4% vs. 71.1%). For all 4 medical specialties surveyed, German nursing homes saw a need for treatment more frequently than Dutch facilities, e.g., 48.3% vs. 11.7% for neurology. In addition, Dutch nursing homes significantly more often considered general practitioners/elder care physicians (GPs/ECPs) to be able to cover these needs. The number of GP/ECP contacts per resident per year was similar in both countries (Germany: 26.5; Netherlands: 28.7). Almost all Dutch facilities had permanently employed allied health professionals (e.g. physiotherapists), whereas this was rarely the case in Germany. CONCLUSIONS: We observed large differences in nursing home residents' medical care. It appears that GPs/ECPs in the Netherlands cover needs deemed to require specialist consultations in Germany. Some differences between countries can possibly be explained by system-cultural differences. Future studies should therefore look closely at the process of medical care provision and its quality in nursing homes in both countries.

[Frequency and characteristics of interventions by community paramedics on people in need of care : Analysis of 2,410 deployment protocols for people aged 65+ years]. / Häufigkeit und Charakteristika von Einsätzen der Gemeindenotfallsanitäter bei Pflegebedürftigen : Analyse von 2410 Einsatzprotokollen bei Personen im Alter von 65+ Jahren.

BACKGROUND: The aim of this study was to obtain a differentiated view of interventions delivered by community paramedics (Gemeindenotfallsanitäter, G­NFS) in older people in need of care living in nursing homes and at home. MATERIALS AND METHODS: A retrospective analysis of G­NFS documentation from 2021 with a focus on patients aged ≥65 years was performed. Data were grouped into callouts to nursing homes or private homes. Interventions, urgency, transport, and further recommendations were analyzed descriptively. RESULTS: Of 5,900 G-NFS protocols, 43.0% (n = 2,410) were related to elderly people (mean age 80.8 years, 49.7% female). A total of 20.6% of these callouts involved nursing home residents, 38.4% (n = 926) were homecare patients, and 41% (n = 988) of callouts were to persons who did not rely on care. No specific interventions except advice were given to 48.4% of nursing home residents, and to even 82.1% of those in homecare and 83.7% of those without care needs. About 60% of the G­NFS interventions were classified as non-urgent. Transport was waived for 63.1% of nursing home residents, for 58.1% in homecare, and for 60.6% of persons without care needs. A visit to the emergency department was recommended to 29.4% of nursing home residents, 37.6% of homecare patients, and 33.6% of persons without need of care. Measures related to urine catheters were documented much more often in nursing homes (38.5%) than in patients in homecare (15.1%) or without need of care (9.3%). CONCLUSION: Community paramedics perform primary care tasks and can contribute to a reduction in unnecessary transport. It should be discussed whether the emergency medical service is responsible for such interventions and how older people in need of care can be cared for according to their needs in the future.

Trends in antipsychotic use among children and adolescents in Germany: a study using 2011-2020 nationwide outpatient claims data.

Introduction: We aimed to provide an update on trends in antipsychotic (AP) use among children and adolescents in Germany. Materials and methods: Based on nationwide outpatient claims data from Germany, we conducted a cross-sectional study. For each year from 2011 to 2020, we determined the prevalence of AP use, defined as the proportion of children and adolescents with at least one AP dispensation. We evaluated trends in AP use by age, sex, and AP class (typical vs. atypical). Additionally, we assessed trends in the specialty of AP prescribers and the frequency of psychiatric diagnoses among AP users. Results: Overall, data from more than 12 million children and adolescents were included for each calendar year (2011: 12,488,827; 2020: 13,330,836). From 2011 to 2020, the overall prevalence of pediatric AP use increased from 3.16 to 3.65 per 1,000, due to an increase in use of both typical APs (from 1.16 to 1.35 per 1,000) and atypical APs (from 2.35 to 2.75 per 1,000). The largest increase in AP use was found among 15- to 19-year-old females, with an increase from 3.88 per 1,000 in 2011 to 7.86 per 1,000 in 2020 (+103%), mainly due to rising quetiapine use (from 1.17 to 3.46 per 1,000). Regarding prescribers' specialty, the proportion of APs prescribed by child and adolescent psychiatrists increased during the studied period (2011: 24.8%; 2020: 36.4%), whereas prescriptions by pediatricians (2011: 26.0%; 2020: 19.9%) and general practitioners (2011: 18.0%; 2020: 12.4%) decreased. Risperidone was the most commonly used AP in males, and quetiapine was the leading AP in females, each with the highest prevalence in 15- to 19-year-olds. In male risperidone users in this age group, the most frequent diagnosis was attention-deficit/hyperactivity disorder (50.4%), while in female quetiapine users it was depression (82.0%). Discussion: Use of APs among children and adolescents in Germany has continued to increase over the last decade. The sharp increase in AP use among 15- to 19-year-old females, which is largely due to an increased use of quetiapine, is remarkable. Potential reasons for this increase-e.g., limited access to psychosocial treatments-should be carefully analyzed. Also, the introduction of more restrictive prescribing guidelines might be considered.

Cochrane review abstracts are getting longer, but this has no large impact on the reporting quality.

OBJECTIVE: To evaluate the reporting of abstracts of Cochrane Reviews according to PRISMA-A and to investigate a possible association with the abstract´s length. METHODS: This is a retrospective, observational study based on all Cochrane Reviews indexed in Medline (via PubMed) until November 18, 2022. In the second part, a random sample of 440 abstracts was drawn, in which PRISMA-A adherence was assessed by two independent reviewers. Analyses were stratified by the year of publication and the number of words. RESULTS: Overall, the median number of words of the 15,188 included abstracts was 469 (IQR 389-686 words), steadily increasing from 353 words in 2000 to 838 words in 2022, with less than one percent of the abstracts in 2022 having ≤ 300 words (in 2000: 30.7%). Analyses on PRISMA-A adherence in the random sample showed a mean score of 6.1 out of 12 fully reported items. Stratified by year, PRISMA-A adherence increased, with higher word counts in 2000-2010 and 2011-2015, while there was no difference in PRISMA-A adherence by abstract length in 2016-2022. CONCLUSION: Over the years, abstracts of Cochrane Reviews have become longer, running up to 1000 words. This conflicts with the Cochrane Handbook, which recommends a maximum length of 400 until it was aligned with MECIR in 2019, which has recommended a length of <700 words since 2012 but allows up to 1000 words. It is debatable whether such long abstracts meet the key goals of abstracts of being informative, accurate, appealing, and concise.

Dental care utilization among home care recipients, nursing home residents, and older adults not in need of long-term care: An observational study based on German insurance claims data.

OBJECTIVES: To describe and compare dental care utilization (DCU) among home care recipients, nursing home residents, and older adults not in need of long-term care (LTC). METHODS: Using nationwide claims data of 8 German statutory health and LTC insurance funds, proportions of home care recipients (n = 68,137), nursing home residents (n = 21,167), and non-LTC dependents (n = 632,205) aged 65+ years with DCU in 2017 were determined and compared. Associations between DCU and individual characteristics and setting were investigated via multivariable logistic regression. The proportions of individuals with DCU one year before and after transition to (a) home care (n = 23,590) and (b) nursing home care (n = 6,583) were compared. RESULTS: Proportions of home care recipients and nursing home residents with DCU were lower compared to non-LTC dependents (51.9, 53.1, and 73.2%, respectively). Adjusted odds ratios for DCU for home care recipients vs. non-LTC dependents ranged from 0.55 (LTC grades 1/2; 95% confidence interval 0.54-0.56) to 0.38 (LTC grades 4/5; 0.36-0.40). For nursing home residents vs. non-LTC dependents they ranged from 0.69 (3; 0.65-0.72) to 0.67 (4/5; 0.63-0.71). Women, older individuals, those with 0-1 diseases of the Elixhauser comorbidity index, dementia, and those from West Germany were also less likely to utilize dental care than their counterparts. Utilization decreased after transition to home care (60.0 vs. 55.6%) and increased after transition to nursing homes (46.1 vs. 53.5%). CONCLUSIONS: Nursing home residents and especially home care recipients utilized dental care less frequently than older non-LTC dependents. Organizational barriers for dental care utilization and ways to remove them should be investigated. CLINICAL SIGNIFICANCE: Dental care utilization among LTC dependents is low and should be improved in both the home care and nursing home setting.

Prevalence of indwelling urinary catheters in nursing home residents: Systematic review.

BACKGROUND: This systematic review examines the prevalence of indwelling urinary catheters in nursing home residents. METHODS: MEDLINE via PubMed, CINAHL, and EMBASE were searched from inception to 9 August 2022. Cross-sectional studies and longitudinal studies with cross-sectional analyses reporting catheter prevalence in nursing home residents were identified and summarized descriptively. Study quality was assessed using the Joanna Briggs Institute's tool. RESULTS: Sixty-seven studies (92.5 % cross-sectional) were included. The reported number of included residents ranged from 73 to 110,656. The median catheter prevalence was 7.3 % (interquartile range 4.3-10.1 %; n = 65 studies). It was higher in Germany (10.2 % [9.7-12.8 %]; n = 15) than in the United States of America (9.3 % [6.3-11.9 %]; n = 9), United Kingdom (6.9 % [4.8-8.5 %]; n = 7), and Sweden (7.3 % [6.4-7.9 %]; n = 6). Furthermore, it was higher among men (17.0 % [16.0-26.0 %]) than among women (5.3 % [4.0-9.5 %]) (n = 9). Only one study investigated differences by age. The prevalence was higher for transurethral (5.7 % [5.6-7.2 %]; n = 12) than for suprapubic (1.2 % [0.6-2.5 %]; n = 13) catheters. Most catheterized residents were long-term catheterized (n = 6) and had their catheter changed within 3 months (n = 2). Symptomatic urinary tract infections were more common among catheterized than among non-catheterized residents (n = 4). DISCUSSION: Catheter prevalence in nursing home residents varies between studies and countries. Prevalence differences by sex, age, and catheter type as well as duration of catheterization, catheter change intervals, and catheter-associated urinary tract infections are rarely reported because most studies do not primarily focus on catheters. Future studies should focus on the circumstances of urinary catheter use and care in nursing home residents. REGISTRATION AND FUNDING: PROSPERO (29 August 2022; CRD42022354358); no funding.

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.

ADOPT: intrinsic protein disorder prediction through deep bidirectional transformers.

Intrinsically disordered proteins (IDPs) are important for a broad range of biological functions and are involved in many diseases. An understanding of intrinsic disorder is key to develop compounds that target IDPs. Experimental characterization of IDPs is hindered by the very fact that they are highly dynamic. Computational methods that predict disorder from the amino acid sequence have been proposed. Here, we present ADOPT (Attention DisOrder PredicTor), a new predictor of protein disorder. ADOPT is composed of a self-supervised encoder and a supervised disorder predictor. The former is based on a deep bidirectional transformer, which extracts dense residue-level representations from Facebook's Evolutionary Scale Modeling library. The latter uses a database of nuclear magnetic resonance chemical shifts, constructed to ensure balanced amounts of disordered and ordered residues, as a training and a test dataset for protein disorder. ADOPT predicts whether a protein or a specific region is disordered with better performance than the best existing predictors and faster than most other proposed methods (a few seconds per sequence). We identify the features that are relevant for the prediction performance and show that good performance can already be gained with <100 features. ADOPT is available as a stand-alone package at https://github.com/PeptoneLtd/ADOPT and as a web server at https://adopt.peptone.io/.

Hospitalization of German and Dutch Nursing Home Residents Depend on Different Long-Term Care Structures: A Systematic Review on Periods of Increased Vulnerability.

OBJECTIVE: To investigate proportions of hospitalized nursing home residents during periods of increased vulnerability, ie, the first 6 months after institutionalization and the last 6 months before death, and comparing the figures between Germany and the Netherlands. DESIGN: Systematic review, registered in PROSPERO (CRD42022312506). SETTING AND PARTICIPANTS: Newly admitted or deceased residents. METHODS: We searched MEDLINE via PubMed, EMBASE, and CINAHL from inception through May 3, 2022. We included all observational studies that reported the proportions of all-cause hospitalizations among German or Dutch nursing home residents during these defined vulnerable periods. Study quality was assessed using the Joanna Briggs Institute's tool. We assessed study and resident characteristics and outcome information and descriptively reported them separately for both countries. RESULTS: We screened 1856 records for eligibility and included 9 studies published in 14 articles (Germany: 8; Netherlands: 6). One study for each country investigated the first 6 months after institutionalization. A total of 10.2% of the Dutch and 42.0% of the German nursing home residents were hospitalized during this time. Overall, 7 studies reported on in-hospital deaths, with proportions ranging from 28.9% to 29.5% for Germany and from 1.0% to 16.3% for the Netherlands. Proportions for hospitalization in the last 30 days of life ranged from 8.0% to 15.7% (Netherlands: n = 2) and from 48.6% to 58.0% (Germany: n = 3). Only German studies assessed the differences by age and sex. Although hospitalizations were less common at older ages, they were more frequent in male residents. CONCLUSIONS AND IMPLICATIONS: During the observed periods, the proportion of nursing homes residents being hospitalized differed greatly between Germany and the Netherlands. The higher figures for Germany can probably be explained by differences in the long-term care systems. There is a lack of research, especially for the first months after institutionalization, and future studies should examine the care processes of nursing home residents following acute events in more detail.

Characteristics and completeness of spontaneous reports by reporter's role in Germany: An analysis of the EudraVigilance database using the example of opioid-associated abuse, dependence, or withdrawal.

Spontaneous reporting is based on the experience of all healthcare professionals (HCPs) but also consumers/non-HCPs and therefore reveals a broad picture of a drug's adverse reactions. Recent studies found substantial differences between reports from these varying sources including the reports' completeness. Using the example of opioid-associated abuse, dependence, or withdrawal, this study analyzed the completeness and characteristics of spontaneous reports from Germany focusing on the reporter. Based on EudraVigilance data, we included all cases of abuse, dependence, or withdrawal associated with opioids indicated for pain therapy and filed from Germany until 2018. Completeness and characteristics were analyzed by a reporter (physician, pharmacist, other HCPs, consumers/non-HCPs) and also by time period to account for other influencing factors. In total, 1721 cases were included, mainly filed by physicians (38.5%) and pharmacists (30.7%). Completeness of demographics varied from 74.5% (other HCPs) to 42.7% (consumers/non-HCPs). Consumers/non-HCPs most often provided any indication/comorbidity (75.2%), whereas this was the case for only 20.2% of pharmacists. Large differences between the reporters were found for almost all characteristics. Other HCPs far more often coded a history of drug abuse, dependence, or withdrawal than other reporters (46.9% vs. 11.6%-24.2%, respectively), and fatal outcomes were also mainly filed by other HCPs (68.1% vs. 14.8%-20.4% by all other reporters). Differences in completeness and characteristics were also observed over time. Studies analyzing spontaneous data should consider potential differences between the various reporting groups in terms of completeness and characteristics. Further, the impact of other influencing factors has to be assessed.

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.