Supporting Error Management and Safety Climate in Ambulatory Care Practices: The CIRSforte Study.

BACKGROUND: To improve patient safety, it is important that healthcare facilities learn from critical incidents. Tools such as reporting and learning systems and team meetings structure error management and promote learning from incidents. To enhance error management in ambulatory care practices, it is important to promote a climate of safety and ensure personnel share views on safety policies and procedures. In contrast to the hospital sector, little research has been dedicated to developing feasible approaches to supporting error management and safety climate in ambulatory care. In this study, we developed, implemented, and evaluated a multicomponent intervention to address how error management and safety climate can be improved in ambulatory care practices. METHODS: In a prospective 1-group pretest-posttest implementation study, we sought to encourage teams in German ambulatory practices to use proven methods such as guidelines, workshops, e-learning, (online) meetings, and e-mail newsletters. A pretest-posttest questionnaire was used to evaluate level and strength of safety climate and psychological behavioral determinants for systematic error management. Using 3 short surveys, we also assessed the state of error management in the participating practices. In semistructured interviews, we asked participants for their views on our intervention measures. RESULTS: Overall, 184 ambulatory care practices nationwide agreed to participate. Level of safety climate and safety climate strength (rwg) improved significantly. Of psychological behavioral determinants, significant improvements could be seen in "action/coping planning" and "action control." Seventy-six percent of practices implemented a new reporting and learning system or modified their existing system. The exchange of information between practices also increased over time. Interviews showed that the introductory workshop and provided materials such as report forms or instructions for team meetings were regarded as helpful. CONCLUSIONS: A significant improvement in safety climate level and strength, as well as participants' knowledge of how to analyze critical incidents, derive preventive measures and develop concrete plans suggest that it is important to train practice teams, to provide practical tips and tools, and to facilitate the exchange of information between practices. Future randomized and controlled intervention trials should confirm the effectiveness of our multicomponent intervention.Trial registration: Retrospectively registered on 18. November 2019 in German Clinical Trials Register No. DRKS00019053.

[17 years of the critical incident reporting and learning system "jeder-fehler-zaehlt.de" for primary care: Analysis of reports]. / 17 Jahre hausärztliches Fehlerberichts- und Lernsystem "jeder-fehler-zaehlt.de" ­ Analyse des Berichtsbestandes.

BACKGROUND: The topic of patient safety has been a subject of much discussion since the end of the last millennium. Ensuring patient safety is a central challenge in health care. An important tool to raise awareness for and learn from adverse events and thus promote patient safety are error-reporting and learning systems (Critical Incident Reporting System = CIRS). METHODS: More than 17 years after its establishment, the CIRS "jeder-fehler-zaehlt.de" (JFZ) for German primary care has undergone a revision in terms of content and technology. The revised web-based system can be used for reporting as well as for classifying and analyzing incident reports. During this process, a descriptive analysis of the current report inventory was carried out, with a focus on serious medication errors. This included all 781 valid incident reports received between September 2004 and December 2021. RESULTS: In 576 of the 781 reports (73.8%), the GP practice was directly involved in the critical incident. Among error types, process errors predominated (79.8% of the classifications, 99.1% of the reports) compared with knowledge and skills errors (20.2% of the classifications, 39.7% of the reports). Communication errors (63.0%) were the most common contributing factor to critical incidents, followed by flaws in tasks and measures (39.7%). Serious and permanent patient harm was rarely reported (8.3% of the reports), whereas temporary patient harm was more common (40.3% of the reports). Incident reports about medication errors with at least serious patient harm included, in particular, substances that affected blood clotting, corticosteroids, and opiates. DISCUSSION: Our results complement the rates that are reported internationally for error types, patient harm, and contributing factors. Serious but preventable adverse events, so-called never events, are frequently associated with the medication process in both JFZ reports and the literature. CONCLUSION: Critical incident reporting systems cannot provide accurate information about the frequency of errors in health care, but they can offer important insights into, for example, serious medication errors. Therefore, they offer both employees and healthcare institutions an opportunity for individual and institutional learning.

The German version of the mHealth App Usability Questionnaire (GER-MAUQ): Translation and validation study in patients with cardiovascular disease.

Objective: In Germany, only a few standardized evaluation tools for assessing the usability of mobile Health apps exist so far. This study aimed to translate and validate the English patient version for standalone apps of the mHealth App Usability Questionnaire (MAUQ) into a German version. Methods: Following scientific guidelines for translation and cross-cultural adaptation, the patient version for standalone apps was forward and back-translated from English into German by an expert panel. In total, 53 participants who were recruited as part of the beta testing process of the recently developed mHealth app HerzFit, answered the questions of the German version of the MAUQ (GER-MAUQ) and the System Usability Scale. Subsequently, a descriptive as well as a psychometric analysis was performed to test validity and reliability. Results: After conducting three cognitive interviews, five items were modified. The values for Cronbach alpha for the entire questionnaire and the three subscales (0.966, 0.814, 0.910, and 0.909) indicate strong internal consistency. The correlation analysis revealed that the scores of the GER-MAUQ, the subscales and the SUS were strongly correlated with each other. The correlation coefficient of the SUS and the GER-MAUQ overall score was r = 0.854, P < 0.001 and the coefficients of the subscales and the SUS were r = 0.642, P < 0.001; r = 0.866, P < 0.001 and r = 0.643, P < 0.001. Conclusions: We have developed a novel German version of the MAUQ and demonstrated it as a reliable and valid measurement tool for assessing the usability of standalone mHealth apps from the patients' perspective. The GER-MAUQ allows a new form of standardized assessment of usability of mHealth apps for patients with cardiovascular disease in Germany. Further research with a larger sample and other samples is recommended.

Collaborative Ambulatory Orthopaedic Care in Patients with Hip and Knee Osteoarthritis: A Retrospective Comparative Cohort Study on Health Utilisation and Economic Outcomes.

Objective: To evaluate a novel healthcare programme for the treatment of patients with hip and knee osteoarthritis in southern Germany in terms of clinical and health economic outcomes. The study is based on claims data from 2014 to 2017. Methods: We conducted a retrospective comparative cohort study of 9768 patients with hip and knee osteoarthritis, of whom 9231 were enrolled in a collaborative ambulatory orthopaedic care programme (intervention group), and 537 patients received usual orthopaedic care (control group). Key features of the programme are coordinated care, morbidity-adapted reimbursement and extended consultation times. Multivariable analysis was performed to determine effects on health utilisation outcomes. The economic analysis considered annual costs per patient from a healthcare payer perspective, stratified by healthcare service sector. Besides multivariable regression analyses, bootstrapping was used to estimate confidence intervals for predicted mean costs by group. Results: Musculoskeletal-disease-related hospitalisation was much less likely among intervention group patients than control group patients [odds ratio (OR): 0.079; 95% CI: 0.062-0.099]. The number of physiotherapy prescriptions per patient was significantly lower in the intervention group (RR: 0.814; 95% CI: 0.721-0.919), while the likelihood of participation in exercise programmes over one year was significantly higher (OR: 3.126; 95% CI: 1.604-6.094). Enrolment in the programme was associated with significantly higher ambulatory costs (€1048 vs. €925), but costs for inpatient care, including hospital stays, were significantly lower (€1003 vs. €1497 and €928 vs. €1300 respectively). Overall annual cost-savings were €195 per patient. Conclusions: Collaborative ambulatory orthopaedic care was associated with reduced hospitalisation in patients with hip and knee osteoarthritis. Health costs for programme participants were lower overall, despite higher costs for ambulatory care.

[SaxoForN-a transregional primary care research network in Dresden and Frankfurt am Main : Design of a practice-based research infrastructure]. / SaxoForN ­ Transregionales allgemeinmedizinisches Forschungspraxennetz Dresden und Frankfurt am Main : Konzept einer innovativen Forschungspraxeninfrastruktur.

Establishing primary care research networks (PCRNs) makes it easier to conduct clinical trials and health services research in a general-practice setting. Since February 2020, the German Federal Ministry of Education and Research (BMBF) has sponsored the development of six PCRNs and a coordination unit throughout Germany, with the aim of setting up a sustainable outpatient research infrastructure to raise the quantity and quality of primary care.The present article describes the design of a PCRN in Dresden and Frankfurt am Main - SaxoForN - and explains its structure and how it operates. The network is a transregional alliance between the two regional PCRNs named "SaxoN" (Dresden/Saxony) and "ForN" (Frankfurt am Main/Hesse), both of which run transregional and local research projects. For this purpose, joint standards and harmonized structures, for example with respect to the data infrastructure, qualifications, participation, and accreditation, were agreed upon and implemented at both sites.A critical success factor will be whether and to what extent the standards and structures, as well as resource planning, can be designed sustainably enough to permit the PCRNs to carry out high-quality research over the long term. To achieve this, the PCRNs will have to attract new practices and build up lasting relationships with them, qualify the research practices in order to standardize processes as far as possible, and regularly document their basic information and healthcare data.

Amitriptyline's anticholinergic adverse drug reactions-A systematic multiple-indication review and meta-analysis.

BACKGROUND: Half the US population uses drugs with anticholinergic properties. Their potential harms may outweigh their benefits. Amitriptyline is among the most frequently prescribed anticholinergic medicinal products, is used for multiple indications, and rated as strongly anticholinergic. Our objective was to explore and quantify (anticholinergic) adverse drug reactions (ADRs) in patients taking amitriptyline vs. placebo in randomized controlled trials (RCTs) involving adults and healthy individuals. METHODS: We searched electronic databases from their inception until 09/2022, and clinical trial registries from their inception until 09/2022. We also performed manual reference searches. Two independent reviewers selected RCTs with ≥100 participants of ≥18 years, that compared amitriptyline (taken orally) versus placebo for all indications. No language restrictions were applied. One reviewer extracted study data, ADRs, and assessed study quality, which two others verified. The primary outcome was frequency of anticholinergic ADRs as a binary outcome (absolute number of patients with/without anticholinergic ADRs) in amitriptyline vs. placebo groups. RESULTS: Twenty-three RCTs (mean dosage 5mg to 300mg amitriptyline/day) and 4217 patients (mean age 40.3 years) were included. The most frequently reported anticholinergic ADRs were dry mouth, drowsiness, somnolence, sedation, fatigue, constitutional, and unspecific anticholinergic ADRs. Random-effects meta-analyses showed anticholinergic ADRs had a higher odd's ratio for amitriptyline versus placebo (OR = 7.41; [95% CI, 4.54 to 12.12]). Non-anticholinergic ADRs were as frequent for amitriptyline as placebo. Meta-regression analysis showed anticholinergic ADRs were not dose-dependent. DISCUSSION: The large OR in our analysis shows that ADRs indicative of anticholinergic activities can be attributed to amitriptyline. The low average age of participants in our study may limit the generalizability of the frequency of anticholinergic ADRs in older patients. A lack of dose-dependency may reflect limited reporting of the daily dosage when the ADRs occurred. The exclusion of small studies (<100 participants) decreased heterogeneity between studies, but may also have reduced our ability to detect rare events. Future studies should focus on older people, as they are more susceptible to anticholinergic ADRs. REGISTRATION: PROSPERO: CRD42020111970.

Anticholinergic burden measures, symptoms, and fall-associated risk in older adults with polypharmacy: Development and validation of a prognostic model.

BACKGROUND: Anticholinergic burden has been associated with adverse outcomes such as falls. To date, no gold standard measure has been identified to assess anticholinergic burden, and no conclusion has been drawn on which of the different measure algorithms best predicts falls in older patients from general practice. This study compared the ability of five measures of anticholinergic burden to predict falls. To account for patients' individual susceptibility to medications, the added predictive value of typical anticholinergic symptoms was further quantified in this context. METHODS AND FINDINGS: To predict falls, models were developed and validated based on logistic regression models created using data from two German cluster-randomized controlled trials. The outcome was defined as "≥ 1 fall" vs. "no fall" within a 6-month follow-up period. Data from the RIME study (n = 1,197) were used in model development, and from PRIMUM (n = 502) for external validation. The models were developed step-wise in order to quantify the predictive ability of anticholinergic burden measures, and anticholinergic symptoms. In the development set, 1,015 patients had complete data and 188 (18.5%) experienced ≥ 1 fall within the 6-month follow-up period. The overall predictive value of the five anticholinergic measures was limited, with neither the employed anticholinergic variable (binary / count / burden), nor dose-dependent or dose-independent measures differing significantly in their ability to predict falls. The highest c-statistic was obtained using the German Anticholinergic Burden Score (0.73), whereby the optimism-corrected c-statistic was 0.71 after interval validation using bootstrapping and 0.63 in the external validation. Previous falls and dizziness / vertigo had the strongest prognostic value in all models. CONCLUSIONS: The ability of anticholinergic burden measures to predict falls does not appear to differ significantly, and the added value they contribute to risk classification in fall-prediction models is limited. Previous falls and dizziness / vertigo contributed most to model performance.

Changes in the pattern of suicides and suicide attempt admissions in relation to the COVID-19 pandemic.

The consequences of the current COVID-19 pandemic for mental health remain unclear, especially regarding the effects on suicidal behaviors. To assess changes in the pattern of suicide attempt (SA) admissions and completed suicides (CS) in association with the COVID-19 pandemic. As part of a longitudinal study, SA admissions and CS are systematically documented and analyzed in all psychiatric hospitals in Frankfurt/Main (765.000 inhabitants). Number, sociodemographic factors, diagnoses and methods of SA and CS were compared between the periods of March-December 2019 and March-December 2020. The number of CS did not change, while the number of SA significantly decreased. Age, sex, occupational status, and psychiatric diagnoses did not change in SA, whereas the percentage of patients living alone while attempting suicide increased. The rate and number of intoxications as a SA method increased and more people attempted suicide in their own home, which was not observed in CS. Such a shift from public places to home is supported by the weekday of SA, as the rate of SA on weekends was significantly lower during the pandemic, likely because of lockdown measures. Only admissions to psychiatric hospitals were recorded, but not to other institutions. As it seems unlikely that the number of SA decreased while the number of CS remained unchanged, it is conceivable that the number of unreported SA cases increased during the pandemic. Our data suggest that a higher number of SA remained unnoticed during the pandemic because of their location and the use of methods associated with lower lethality.

Strength of Safety Measures Introduced by Medical Practices to Prevent a Recurrence of Patient Safety Incidents: An Observational Study.

OBJECTIVE: The aim of this study was to analyze the strength of safety measures described in incident reports in outpatient care. METHODS: An incident reporting project in German outpatient care included 184 medical practices with differing fields of specialization. The practices were invited to submit anonymous incident reports to the project team 3 times for 17 months. Using a 14-item coding scheme based on international recommendations, we deductively coded the incident reports and safety measures. Safety measures were classified as "strong" (likely to be effective and sustainable), "intermediate" (possibly effective and sustainable), or "weak" (less likely to be effective and sustainable). RESULTS: The practices submitted 245 incident reports. In 160 of them, 243 preventive measures were described, or an average of 1.5 per report. The number of documented measures varied from 1 in 67% to 4 in 5% of them. Four preventive measures (2%) were classified as strong, 37 (15%) as intermediate, and 202 (83%) as weak. The most frequently mentioned measures were "new procedure/policy" (n = 121) and "information/notification/warning" (n = 45). CONCLUSIONS: The study provides examples of critical incidents in medical practices and for the first time examines the strength of ensuing measures introduced in outpatient care. Overall, the proportion of weak measures is (too) high, indicating that practices need more support in identifying strong measures.

Differences in opioid prescription rates between patients with musculoskeletal disorders enrolled in coordinated ambulatory healthcare and patients receiving usual care: a retrospective observational cohort study.

OBJECTIVES: To compare opioid prescription rates between patients enrolled in coordinated ambulatory care and patients receiving usual care. DESIGN: In this retrospective cohort study, we analysed claims data for insured patients with non-specific/specific back pain or osteoarthritis of hip or knee from 2014 to 2017. SETTING: The study was based on administrative data provided by the statutory health insurance fund 'Allgemeine Ortskrankenkasse', in the state of Baden-Wurttemberg, Germany. PARTICIPANTS: The intervention group consisted of patients enrolled in a coordinated ambulatory healthcare model; the control group included patients receiving usual care. Outcomes were overall strong and weak opioid prescriptions. Generalised linear regression models were used to analyse the effect of the intervention. RESULTS: Overall, 46 001 (non-specific 18 787/specific 27 214) patients with back pain and 19 366 patients with osteoarthritis belonged to the intervention group, and 7038 (2803/4235) and 963 patients to the control group, respectively. No significant difference in opioid prescriptions existed between the groups. However, the chance of being prescribed strong opioids was significantly lower in the intervention group (non-specific back pain: Odds Ratio (OR) 0.735, 95% Confidential Interval (CI) 0.563 to 0.960; specific back pain: OR 0.702, 95% CI 0.577 to 0.852; osteoarthritis: OR 0.644, 95% CI 0.464 to 0.892). The chance of being prescribed weak opioids was significantly higher in patients with specific back pain (OR 1.243, 95% CI 1.032 to 1.497) and osteoarthritis (OR 1.493, 95% CI 1.037 to 2.149) in the intervention group. CONCLUSION: Coordinated ambulatory healthcare appears to be associated with a lower prescription rate for strong opioids in patients with chronic musculoskeletal disorders. TRIAL REGISTRATION NUMBER: German Clinical Trials Register (DRKS00017548).

Evaluation of a collaborative ambulatory orthopedic care program for patients with hip and knee osteoarthritis: a comparative observational cohort study.

BACKGROUND: In 2014, the novel orthopedic care program was established by the AOK health insurance fund in southern Germany to improve ambulatory care for patients with musculoskeletal disorders. The program offers extended consultation times, structured collaboration between general practitioners and specialists, as well as a renewed focus on guideline-recommended therapies and patient empowerment. The aim of this study was to assess the impact of the program on health service utilization in patients with hip and knee osteoarthritis (OA). METHODS: This retrospective cohort study, which is based on claims data, evaluated health service utilization in patients with hip and knee OA from 2014 to 2017. The intervention group comprised OA patients enrolled in collaborative ambulatory orthopedic care, and the control group received usual care. The outcomes were participation in exercise interventions, prescription of physical therapy, OA-related hospitalization, and endoprosthetic surgery rates. Generalized linear regression models were used to analyze the effect of the intervention. RESULTS: Claims data for 24,170 patients were analyzed. Data for the 23,042 patients in the intervention group were compared with data for the 1,128 patients in the control group. Participation in exercise interventions (Odds Ratio (OR): 1.781; 95% Confidence Interval (CI): 1.230-2.577; p = 0.0022), and overall prescriptions of physical therapy (Rate Ratio (RR): 1.126; 95% CI: 1.025-1.236; p = 0.0128) were significantly higher in the intervention group. The intervention group had a significantly lower risk of OA -related hospitalization (OR: 0.375; 95% CI: 0.290-0.485; p < 0.0001). Endoprosthetic surgery of the knee was performed in 53.8% of hospitalized patients in the intervention group vs. 57.5% in the control group; 27.7% of hospitalized patients underwent endoprosthetic surgery of the hip in the intervention group versus 37.0% in the control group. CONCLUSIONS: In patients with hip and knee OA, collaborative ambulatory orthopedic care is associated with a lower risk of OA-related hospitalization, higher participation in exercise interventions, and more frequently prescribed physical therapy.

Stakeholder Perspectives on the Development and Implementation of a Polypharmacy Management Program in Germany: Results of a Qualitative Study.

Structured management programs have been developed for single diseases but rarely for patients with multiple medications. We conducted a qualitative study to investigate the views of stakeholders on the development and implementation of a polypharmacy management program in Germany. Overall, we interviewed ten experts in the fields of health policy and clinical practice. Using content analysis, we identified inclusion criteria for the selection of suitable patients, the individual elements that should make up such a program, healthcare providers and stakeholders that should be involved, and factors that may support or hinder the program's implementation. All stakeholders were well aware of polypharmacy-related risks and challenges, as well as the urgent need for change. Intervention strategies should address all levels of care and include all concerned patients, caregivers, healthcare providers and stakeholders, and involved parties should agree on a joint approach.

General practitioner-centred paediatric primary care reduces risk of hospitalisation for mental disorders in children and adolescents with ADHD: findings from a retrospective cohort study.

BACKGROUND: General practitioners (GPs) play an essential role in the sustainable management of attention-deficit/hyperactivity disorder (ADHD). To our knowledge, the healthcare programme described here is the first integrated care programme for paediatric ambulatory care embedded in GP-centred-healthcare in Germany. OBJECTIVES: To compare the health-service-utilisation of patients with ADHD enrolled in a GP-centred-paediatric-primary-care-programme with usual care in terms of disease-related hospitalisation, pharmacotherapy and psychotherapy. METHODS: In 2018, we conducted a retrospective cohort study of 3- to 18-year-old patients with ADHD in Baden-Wuerttemberg, southern Germany. The intervention group (IG) comprised patients enrolled in a GP-centred-paediatric-primary-healthcare-programme and consulted a participating GP for ADHD at least once. GP-centred-paediatric-primary-care provides high continuity of care, facilitated access to specialist care, extended routine examinations and enhanced transition to adult healthcare. Patients in the control group (CG) received usual care, meaning they consulted a non-participating GP for ADHD at least once. Main outcomes were disease-related hospitalisation, pharmacotherapy and psychotherapy. Multivariable logistic regression was performed to compare groups. RESULTS: A total of 2317 patients were included in IG and 4177 patients in CG. Mean age was 8.9 ± 4.4. The risk of mental-disorder-related hospitalisations was lower in IG than CG (odds ratio (OR): 0.666, 95% confidence interval (CI): 0.509-0.871). The prescription rate for stimulants was lower in IG (OR: 0.817; 95% CI: 0.732-0.912). There was no statistically significant difference in the participation rate of patients in cognitive behavioural therapy between groups (OR: 0.752; 95% CI: 0.523-1.080). CONCLUSION: Children and adolescents with ADHD enrolled in GP-centred-paediatric-primary-care are at lower risk of mental-disorder-related hospitalisation and less likely to receive stimulants.

[Similarities and differences in specialized outpatient palliative care for adults, children and adolescents: results from focus group discussions with health care professionals]. / Gemeinsamkeiten und Unterschiede in der spezialisierten ambulanten Palliativversorgung von Erwachsenen sowie Kindern und Jugendlichen: Ergebnisse aus Fokusgruppendiskussionen mit Leistungserbringer*innen.

BACKGROUND: In Germany, people with life-limiting conditions and complex symptoms are eligible for specialized outpatient palliative care (SOPC). Requirements, delivery and goals of SOPC have been laid down by the Federal Joint Committee in a nationwide guideline. The guideline emphasizes the need to consider the special needs of children and adolescents with life-limiting conditions. A specification of these needs has so far been missing. The focus group discussion presented here aimed at investigating similarities and differences between the specialized outpatient palliative care of adults (SOPC for adults) on the one hand, and children and adolescents (SOPPC) on the other hand, from the perspective of health care professionals in order to further define specifics of SOPPC. METHOD: In three focus group discussions a total of 11 nursing and 8 medical professionals from SOPC for adults and SOPPC engaged in face-to-face discussions on the similarities and differences of both care forms. Discussions were designed openly and stimulated with three guiding questions only. Focus group discussions were audio-recorded, transcribed verbatim and analyzed by thematic analysis supported by the software MAXQDA. RESULTS: Within the following six themes, similarities as well as key differences between SOPC and SOPPC were identified: the participants discussed diseases, coverage area and locations, therapy goals, the psychosocial care situation, the role of relatives and end-of-life care. From the participants' perspective different underlying diseases constitute a main difference that causes further differences in the expertise required. Furthermore, SOPC for adults and SOPPC differ in the dimension of areas covered by one team, the number of patients per team and the reasons for SOPC visits. Differences in terminal care and the mourning process within the team became evident. Some similarities existed regarding goal-setting, psychosocial care and the role of relatives, but concrete patterns and the importance of these aspects differed because a particularly complex and emotional communication is required when a child is dying. CONCLUSION: From the perspective of health care professionals, SOPC for adults and SOPPC differ with regard to underlying diseases as well as care patterns such as collaboration with relatives and their need for psychosocial support. Therefore, the care for children, adolescents and young adults with life-limiting conditions and pediatric diseases all over Germany should be delivered within the frame of an independent care structure by teams whose members possess specific pediatric expertise.

Evidence-Based Decision Support for a Structured Care Program on Polypharmacy in Multimorbidity: A Guideline Upgrade Based on a Realist Synthesis.

Evidence-based clinical guidelines generally consider single conditions, and rarely multimorbidity. We developed an evidence-based guideline for a structured care program to manage polypharmacy in multimorbidity by using a realist synthesis to update the German polypharmacy guideline including the following five methods: formal prioritization in focus groups; systematic guideline review of evidence-based multimorbidity/polypharmacy guidelines; evidence search/synthesis and recommendation development; multidisciplinary consent of recommendations; feasibility test of updated guideline. We identified the need for a better description of the target group, decision support, prioritization of medication, consideration of patient preferences and anticholinergic properties, and of healthcare interfaces. We conducted a systematic guideline review of eight guidelines and extracted and synthesized recommendations using the Ariadne principles. We also included 48 systematic reviews. We formulated and agreed upon 34 recommendations for the revised guideline. During the feasibility test, guideline use enabled 57% of GPs to identify problems, leading to medication changes in 49% and self-assessed improvement in 56% of patients. Although 58% of GPs felt that it was too long, 92% recommended it. Polypharmacy should be systematically reviewed at least annually. Patients, family members, and healthcare professionals should monitor and adjust it using prospective process validation, taking into account patient preferences and agreed treatment goals.

Care practices of specialized outpatient pediatric palliative care teams in collaboration with parents: Results of participatory observations.

BACKGROUND: Collaboration between parents and professional care providers is an essential part of pediatric palliative care. As children are embedded in family systems and many of the patients are not able to communicate verbally, their parents are the primary interaction partners for palliative care providers. International standards for pediatric palliative care in Europe state that parents should be supported, acknowledged as the primary carers and involved as partners in all care and decisions. AIM: To find out through which care practices pediatric palliative care teams shape collaboration with parents in everyday care. DESIGN: Ethnographic method of participatory observations. Field notes were analyzed using thematic analysis. SETTING/PARTICIPANTS: Researchers accompanied three pediatric palliative care teams on home visits to eight different families caring for a child with life-limiting conditions. RESULTS: Care practices of palliative care teams were characterized by familiarity, a resource-oriented attitude, empowerment of parents, shared decision-making and support for parents. Palliative care teams not only provided palliative medical treatment for the children, but also developed a trusting care partnership with parents. The teams employed a sensitive and multifaceted communication style in their collaboration with parents. CONCLUSIONS: Care practices in pediatric palliative care require time, communication skills, and a high level of psychosocial competence, to develop a trusting, collaborative relationship with parents. This should be taken into consideration when establishing pediatric palliative care structures, preparing guidelines, training staff, and deciding upon appropriate remuneration.

Characteristics of Critical Incident Reporting Systems in Primary Care: An International Survey.

OBJECTIVE: The aim of the study was to support the development of future critical incident reporting systems (CIRS) in primary care by collecting information on existing systems. Our focus was on processes used to report and analyze incidents, as well as strategies used to overcome difficulties. METHODS: Based on literature from throughout the world, we identified existing CIRS in primary care. We developed a questionnaire and sent it to operators of a purposeful sample of 17 CIRS in primary care. We used cross-case analysis to compare the answers and pinpoint important similarities and differences in the CIRS in our sample. RESULTS: Ten CIRS operators filled out the questionnaire, and 9 systems met our inclusion criteria. The sample of CIRS came from 8 different countries and was rather heterogeneous. The reporting systems invited a broad range of professions to report, with some also including reports by patients. In most cases, reporting was voluntary and conducted via an online reporting form. Reports were analyzed locally, centrally, or both. The various CIRS used interesting ideas to deal with barriers. Some, for example, used confidential reporting modes as a compromise between anonymity and the need for follow-up investigations, whereas others used smartphone applications and call centers to speed up the reporting process. CONCLUSIONS: We found multiple CIRS that have operated in primary care for many years and have received a high number of reports. They were largely developed in accordance with recommendations found in literature. Developers of future systems may find this overview useful.

Specialised outpatient paediatric palliative care team-parent collaboration: narrative interviews with parents.

OBJECTIVE: In Germany, children with life-limiting conditions and complex symptoms are eligible for specialised outpatient palliative care (SOPC). In the federal state of Hesse, SOPC for children (SOPPC) is delivered by teams with paediatric expertise. While burdened by the life-limiting condition of their child, parents must also fulfill their roles as main care providers and decision makers. Collaboration between parents and SOPPC teams is important, as the intermittent care and uncertainty it entails often lasts for several months or years. We explored parents' experiences and their demands of collaboration with SOPPC teams. METHODS: We conducted nine narrative interviews with 13 parents of children and adolescents with life-limiting conditions and used a grounded theory approach to analyse interview data. RESULTS: Parents stressed the importance of paediatric expertise, honesty, psychosocial support, an individualised approach, experience of self-efficacy and the need to be recognised as experts for their children. The narrative interviews showed that collaboration between parents and SOPPC teams was characterised by parents' need for specialised professional assistance and their simultaneous empowerment by SOPPC teams. CONCLUSIONS: Parents' perceptions of what good collaboration with SOPPC teams entails are manifold. To meet these complex needs, SOPPC requires time and specialised expertise.

Effectiveness of the application of an electronic medication management support system in patients with polypharmacy in general practice: a study protocol of cluster-randomised controlled trial (AdAM).

INTRODUCTION: Clinically complex patients often require multiple medications. Polypharmacy is associated with inappropriate prescriptions, which may lead to negative outcomes. Few effective tools are available to help physicians optimise patient medication. This study assesses whether an electronic medication management support system (eMMa) reduces hospitalisation and mortality and improves prescription quality/safety in patients with polypharmacy. METHODS AND ANALYSIS: Planned design: pragmatic, parallel cluster-randomised controlled trial; general practices as randomisation unit; patients as analysis unit. As practice recruitment was poor, we included additional data to our primary endpoint analysis for practices and quarters from October 2017 to March 2021. Since randomisation was performed in waves, final study design corresponds to a stepped-wedge design with open cohort and step-length of one quarter. SCOPE: general practices, Westphalia-Lippe (Germany), caring for BARMER health fund-covered patients. POPULATION: patients (≥18 years) with polypharmacy (≥5 prescriptions). SAMPLE SIZE: initially, 32 patients from each of 539 practices were required for each study arm (17 200 patients/arm), but only 688 practices were randomised after 2 years of recruitment. Design change ensures that 80% power is nonetheless achieved. INTERVENTION: complex intervention eMMa. FOLLOW-UP: at least five quarters/cluster (practice). recruitment: practices recruited/randomised at different times; after follow-up, control group practices may access eMMa. OUTCOMES: primary endpoint is all-cause mortality and hospitalisation; secondary endpoints are number of potentially inappropriate medications, cause-specific hospitalisation preceded by high-risk prescribing and medication underuse. STATISTICAL ANALYSIS: primary and secondary outcomes are measured quarterly at patient level. A generalised linear mixed-effect model and repeated patient measurements are used to consider patient clusters within practices. Time and intervention group are considered fixed factors; variation between practices and patients is fitted as random effects. Intention-to-treat principle is used to analyse primary and key secondary endpoints. ETHICS AND DISSEMINATION: Trial approved by Ethics Commission of North-Rhine Medical Association. Results will be disseminated through workshops, peer-reviewed publications, local and international conferences. TRIAL REGISTRATION: NCT03430336. ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03430336).

Predicting hospital admissions from individual patient data (IPD): an applied example to explore key elements driving external validity.

OBJECTIVE: To explore factors that potentially impact external validation performance while developing and validating a prognostic model for hospital admissions (HAs) in complex older general practice patients. STUDY DESIGN AND SETTING: Using individual participant data from four cluster-randomised trials conducted in the Netherlands and Germany, we used logistic regression to develop a prognostic model to predict all-cause HAs within a 6-month follow-up period. A stratified intercept was used to account for heterogeneity in baseline risk between the studies. The model was validated both internally and by using internal-external cross-validation (IECV). RESULTS: Prior HAs, physical components of the health-related quality of life comorbidity index, and medication-related variables were used in the final model. While achieving moderate discriminatory performance, internal bootstrap validation revealed a pronounced risk of overfitting. The results of the IECV, in which calibration was highly variable even after accounting for between-study heterogeneity, agreed with this finding. Heterogeneity was equally reflected in differing baseline risk, predictor effects and absolute risk predictions. CONCLUSIONS: Predictor effect heterogeneity and differing baseline risk can explain the limited external performance of HA prediction models. With such drivers known, model adjustments in external validation settings (eg, intercept recalibration, complete updating) can be applied more purposefully. TRIAL REGISTRATION NUMBER: PROSPERO id: CRD42018088129.