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.

Are people interested in receiving advice from their general practitioner on how to protect their health during heatwaves? A survey of the German population.

OBJECTIVE: Climate change increases the frequency, intensity and length of heatwaves, which puts a particular strain on the health of vulnerable population groups. General practitioners (GPs) could reach these people and provide advice on protective health behaviour against heat. Data is lacking on whether and what topic of GP advice people are interested in, and whether specific person characteristics are associated with such interests. DESIGN: Cross-sectional, nationwide, face-to-face household survey, conducted during winter 2022/2023. SETTING: Germany. PARTICIPANTS: Population-based sample of 4212 respondents (aged 14-96 years), selected by using multistratified random sampling (50%) combined with multiquota sampling (50%). MAIN OUTCOME MEASURE: Interest in receiving GP advice on health protection during heatwaves (yes/no), and the topic people find most important (advice on drinking behaviour, nutrition, cooling, cooling rooms, physical activity or medication management). Associations between predefined person characteristics and the likelihood of interest were estimated using adjusted logistic regressions. RESULTS: A total of 4020 respondents had GP contact and provided data on the outcome measure. Of these, 23% (95% CI=22% to 25%) expressed interest in GP advice. The likelihood of expressing interest was positively associated with being female, older age (particularly those aged 75+ years: 38% were interested), having a lower level of educational attainment, having a migration background, living in a more urban area, and living in a single-person household. It was negatively associated with increasing income. Advice on medication management received highest interest (25%). CONCLUSIONS: During winter season 2022/2023, around one quarter of the German population with GP contact-and around 40% of those aged 75+ years-was estimated to have a stated interest in receiving GP advice on protective health behaviour during heatwaves, especially on medication management. Climate change is creating new demands for healthcare provision in general practice. This study provides initial relevant information for research and practice aiming to address these demands.

Requirements analysis for an AI-based clinical decision support system for general practitioners: a user-centered design process.

BACKGROUND: As the first point of contact for patients with health issues, general practitioners (GPs) are frequently confronted with patients presenting with non-specific symptoms of unclear origin. This can result in delayed, prolonged or false diagnoses. To accelerate and improve the diagnosis of diseases, clinical decision support systems would appear to be an appropriate tool. The objective of the project 'Smart physician portal for patients with unclear disease' (SATURN) is to employ a user-centered design process based on the requirements analysis presented in this paper to develop an artificial Intelligence (AI)-based diagnosis support system that specifically addresses the needs of German GPs. METHODS: Requirements analysis for a GP-specific diagnosis support system was conducted in an iterative process with five GPs. First, interviews were conducted to analyze current workflows and the use of digital applications in cases of diagnostic uncertainty (as-is situation). Second, we focused on collecting and prioritizing tasks to be performed by an ideal smart physician portal (to-be situation) in a workshop. We then developed a task model with corresponding user requirements. RESULTS: Numerous GP-specific user requirements were identified concerning the tasks and subtasks: performing data entry (open system, enter patient data), reviewing results (receiving and evaluating results), discussing results (with patients and colleagues), scheduling further diagnostic procedures, referring to specialists (select, contact, make appointments), and case closure. Suggested features particularly concerned the process of screening and assessing results: e.g., the system should focus more on atypical patterns of common diseases than on rare diseases only, display probabilities of differential diagnoses, ensure sources and results are transparent, and mark diagnoses that have already been ruled out. Moreover, establishing a means of using the platform to communicate with colleagues and transferring patient data directly from electronic patient records to the system was strongly recommended. CONCLUSIONS: Essential user requirements to be considered in the development and design of a diagnosis system for primary care could be derived from the analysis. They form the basis for mockup-development and system engineering.

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.

Providing an interactive undergraduate elective on safety culture online - concept and evaluation.

BACKGROUND: The COVID-19 pandemic has made it more difficult to maintain high quality in medical education. As online formats are often considered unsuitable, interactive workshops and seminars have particularly often been postponed or cancelled. To meet the challenge, we converted an existing interactive undergraduate elective on safety culture into an online event. In this article, we describe the conceptualization and evaluation of the elective. METHODS: The learning objectives of the safety culture elective remained unchanged, but the teaching methods were thoroughly revised and adapted to suit an online setting. The online elective was offered as a synchronous two-day course in winter semester 2020/21 during the "second wave" of the COVID-19 pandemic in Germany. At the end of each day, participating students evaluated the elective by completing an online survey. Items were rated on a six-point Likert scale. We used SPSS for data analysis. RESULTS: Twenty medical undergraduates completed the elective and rated it extremely positively (1.1 ± 0.2). Students regard safety culture as very important and felt the learning objectives had been achieved. Moreover, they were very satisfied with the design and content of the elective, and especially with interactive elements like role-play. Around 55% of participants would recommend continuing to offer the online elective after the pandemic. CONCLUSIONS: It makes sense to offer undergraduate medical students online elective courses on safety culture, especially during a pandemic. The elective described here can serve as a best practice example of how to teach safety culture to undergraduates, especially when physical presence is unfeasible. Electives requiring a high degree of interaction can also function well online.

A scoping review of mHealth monitoring of pediatric bronchial asthma before and during COVID-19 pandemic.

Mobile (m) Health technology is well-suited for Remote Patient Monitoring (RPM) in a patient's habitual environment. In recent years there have been fast-paced developments in mHealth-enabled pediatric RPM, especially during the COVID-19 pandemic, necessitating evidence synthesis. To this end, we conducted a scoping review of clinical trials that had utilized mHealth-enabled RPM of pediatric asthma. MEDLINE, Embase and Web of Science were searched from September 1, 2016 through August 31, 2021. Our scoping review identified 25 publications that utilized synchronous and asynchronous mHealth-enabled RPM in pediatric asthma, either involving mobile applications or via individual devices. The last three years has seen the development of evidence-based, multidisciplinary, and participatory mHealth interventions. The quality of the studies has been improving, such that 40% of included study reports were randomized controlled trials. In conclusion, there exists high-quality evidence on mHealth-enabled RPM in pediatric asthma, warranting future systematic reviews and/or meta-analyses of the benefits of such RPM.

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.

Patient Safety and the COVID-19 Pandemic in Germany: A Repeated Population-Based Cross-Sectional Survey.

The coronavirus (COVID-19) has presented Germany with major challenges and has led to concerns about patient safety. We conducted an observational, population-based, nationwide, repeated cross-sectional survey on patient safety in Germany in 2019, 2020, and 2021. Each of the three samples consisted of 1000 randomly recruited adults. Self-reported data via computer-assisted telephone interviews were taken from TK Monitor of Patient Safety. Perceptions, experience, and knowledge relating to patient safety were assessed. The majority of respondents considered medical treatment to involve risks to patient safety. This proportion decreased during the pandemic. The majority also had a high degree of self-efficacy regarding the prevention of medical errors, whereby the percentage that felt well informed with regard to patient safety rose throughout the pandemic. The proportion of persons that suspected they had in the past experienced an error in their treatment remained steady at one third as well as the reported errors. In 2020, 65% of respondents thought health communication with service providers (e.g., extent and comprehensibility of information) remained unchanged during the pandemic, while 35% reported that medical appointments had been cancelled or postponed. This study is the first to assess patient safety from a general population perspective during the coronavirus pandemic in Germany. COVID-19 had a positive impact on perceived patient safety but no impact on suspected and reported errors. Self-efficacy with regard to medical error prevention steadily increased in the general population, and people considered themselves well informed.

Everyday lives of middle-aged persons living with multimorbidity: protocol of a mixed-methods systematic review.

INTRODUCTION: Multimorbidity is the simultaneous occurrence of several (chronic) diseases. Persons living with multimorbidity not only have complex care needs, but the burden of care often has a negative impact on their family lives, leisure time and professional activities. The aim of this project is to systematically review the literature to assess how multimorbidity affects the everyday lives of middle-aged persons, and to find out what abilities and resources help in the development of coping strategies to overcome the challenges of living with it. METHODS AND ANALYSIS: We will systematically search for studies reporting on the everyday life experiences of middle-aged persons (30-60 years) with multimorbidity (≥2 chronic conditions) in MEDLINE, CINAHL, PsycINFO, Social Sciences Citation Index, Social Sciences Citation Index Expanded, PSYNDEX and The Cochrane Library from inception. We will include all primary studies that use quantitative, qualitative and mixed methodologies, irrespective of publication date/study setting.Two independent reviewers will screen titles/abstracts/full texts, extract data from the selected studies and present evidence in terms of study/population characteristics, data collection method and the phenomenon of interest, that is, everyday life experiences of middle-aged persons with multimorbidity. Risk of bias will be independently assessed by two reviewers using the Mixed Methods Appraisal Tool. We will use a convergent integrated approach on qualitative/quantitative studies, whereby information will be synthesised narratively and, if possible, quantitatively. ETHICS AND DISSEMINATION: Ethical approval is not required due to the nature of the proposed systematic review. Results from this research will be disseminated at relevant (inter)national conferences and via publication in peer-reviewed journals. PROSPERO REGISTRATION NUMBER: CRD42021226699.

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).

Implementation and use of mHealth home telemonitoring in adults with acute COVID-19 infection: a scoping review protocol.

INTRODUCTION: mHealth refers to digital technologies that, via smartphones, mobile apps and specialised digital sensors, yield real-time assessments of patient's health status. In the context of the COVID-19 pandemic, these technologies enable remote patient monitoring, with the benefit of timely recognition of disease progression to convalescence, deterioration or postacute sequelae. This should enable appropriate medical interventions and facilitate recovery. Various barriers, both at patient and technology levels, have been reported, hindering implementation and use of mHealth telemonitoring. As systematised and synthesised evidence in this area is lacking, we developed this protocol for a scoping review on mHealth home telemonitoring of acute COVID-19. METHODS AND ANALYSIS: We compiled a search strategy following the PICO (Population, Intervention, Comparator, Outcome) and PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses recommendation for Scoping Reviews) guidelines. MEDLINE, Embase and Web of Science will be searched from 1 March 2020 to 31 August 2021. Following the title and abstract screening, we will identify, systematise and synthesise the available knowledge. Based on pilot searches, we preview three themes for descriptive evidence synthesis. The first theme relates to implementation and use of mHealth telemonitoring, including reported barriers. The second theme covers the interactions of the telemonitoring team within and between different levels of the healthcare system. The third theme addresses how this telemonitoring warrants the continuity of care, also during disease transition into deterioration or postacute sequelae. ETHICS AND DISSEMINATION: The studied evidence is in the public domain, therefore, no specific ethics approval is required. Evidence dissemination will be via peer-reviewed publications, conference presentations and reports to the policy makers.

[Patient perspectives on patient safety: Results of a population-based survey in Germany]. / Subjektive Informiertheit von Patient*innen zum Thema Patientensicherheit: Ergebnisse einer Bevölkerungsbefragung in Deutschland.

INTRODUCTION: The growing number of people with multimorbidity and polypharmacy in Germany has led to increasing complexity in health care and risks to patient safety. A high priority should therefore be placed on identifying and preventing avoidable adverse events. The patient perspective plays an important role in improving patient safety. In this study, we conducted a representative, population-based survey of knowledge, perceptions and experiences of patient safety, especially of subjectively experienced errors in health care. Our aim was, in particular, to assess patient safety from the patients' point of view, and to analyze differences in assessments of risk and preventability between persons that felt well or poorly informed about patient safety topics. METHODS: In 2019, computer-assisted telephone interviews were conducted nationwide as part of the "TK-Monitor Patient Safety" project. Recruitment was carried out by using multistage selection and forming a stratified random sample. Adults (18 years and older) with sufficient knowledge of German were included. The survey was conducted using a structured guideline containing 21 questions concerning perceptions and experiences of patient safety, and 12 questions on sociodemographic factors. The results were analyzed both descriptively and using inferential statistical methods. RESULTS: Of a total of 1,000 respondents (51% female), approx. half (52%) were gainfully employed, and 57% rated their state of health as "very good" or "good". The patients regarded data protection, medication errors, hospital infections and diagnostic (un)certainty as of major relevance to patient safety. Overall, 55% of the respondents rated their knowledge of patient safety as "very good" or "good". The results showed that subjective knowledge was negatively associated with important outcome parameters such as having experience of medication errors or suspecting errors had been made in a medical examination or treatment. Patients that considered themselves well-informed also reckoned they could contribute towards increasing safety in health care. DISCUSSION: The respondents considered diagnostic uncertainty to be one of the greatest risks to their person. This shows that they recognized a need for further information and felt this need was inadequately satisfied in the German research landscape. With regard to the correlation between subjective knowledge and outcome parameters, it is also necessary to analyze whether the respondents' subjective knowledge reflects their actual knowledge, as this would be necessary for preventive measures to be effective. This question will be the subject of further studies. CONCLUSION: The patient perspective is an important addition to the study of the safety of medical care in Germany. Factors influencing subjective knowledge should be investigated. Furthermore, regular surveys would be desirable in order to gain greater insight into the topic.

"I must, and I can live with that": a thematic analysis of patients' perspectives on polypharmacy and a digital decision support system for GPs.

BACKGROUND: To investigate patients' perspectives on polypharmacy and the use of a digital decision support system to assist general practitioners (GPs) in performing medication reviews. METHODS: Qualitative interviews with patients or informal caregivers recruited from participants in a cluster-randomized controlled clinical trial (cRCT). The interviews were transcribed verbatim and analyzed using thematic analysis. RESULTS: We conducted 13 interviews and identified the following seven themes: the patients successfully integrated medication use in their everyday lives, used medication plans, had both good and bad personal experiences with their drugs, regarded their healthcare providers as the main source of medication-related information, discussed medication changes with their GPs, had trusting relationships with them, and viewed the use of digital decision support tools for medication reviews positively. No unwanted adverse effects were reported. CONCLUSIONS: Despite drug-related problems, patients appeared to cope well with their medications. They also trusted their GPs, despite acknowledging polypharmacy to be a complex field for them. The use of a digital support system was appreciated and linked to the hope that reasons for selecting specific medication regimens would become more comprehensible. Further research with a more diverse sampling might add more patient perspectives. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03430336 . Registered on February 6, 2018.

[Design and evaluation of a preclinical medical elective titled "Safety culture in healthcare: Every error counts!"] / Konzeption und Evaluation eines vorklinischen medizinischen Wahlpflichtfaches "Sicherheitskultur in der Medizin: Jeder Fehler zählt!".

INTRODUCTION: The World Health Organization has called for more importance to be attached to the subject of patient safety in medical studies. However, teaching staff are unsure when the right time is to include this topic in existing medical school curricula. The aim of this article is to present the learning objectives, design and evaluation of a two-day elective on patient safety offered in the preclinical phase of medical studies at the Faculty of Medicine, University of Frankfurt am Main. To the best of our knowledge, no existing elective on safety culture has been provided at such an early stage of medical studies in Germany. METHODS: After defining learning objectives and teaching methods, the safety culture elective was offered in the winter term 2019/20. Based on a questionnaire, a quantitative and qualitative evaluation of the students' acceptance of the elective was carried out. We also sought to investigate whether group role-play was considered an effective means of communicating the teaching content. Acceptance and rejection of the elective were evaluated on a six-point Likert scale. RESULTS: The resulting elective, consisting of topical input via film, an introductory speech, role-play and discussions, is presented. Nineteen students in the preclinical phase of their medical studies took part. Overall, the quantitative and qualitative evaluation delivered positive results (1.2±0.5), and the topic was perceived to very important. The students considered the didactic implementation and the learning objectives to be very good, and they became acquainted with different sources of error. DISCUSSION: The preclinical elective would appear to be suitable for demonstrating the importance of medical safety to medical students and teaching them how to deal with the topic constructively. It can be viewed as a best-practice example for the development of comparable learning formats at medical faculties. CONCLUSION: The results show that the preclinical phase is a suitable time to illustrate the importance of the subject of patient safety during medical studies.

Development and internal validation of prognostic models to predict negative health outcomes in older patients with multimorbidity and polypharmacy in general practice.

BACKGROUND: Polypharmacy interventions are resource-intensive and should be targeted to those at risk of negative health outcomes. Our aim was to develop and internally validate prognostic models to predict health-related quality of life (HRQoL) and the combined outcome of falls, hospitalisation, institutionalisation and nursing care needs, in older patients with multimorbidity and polypharmacy in general practices. METHODS: Design: two independent data sets, one comprising health insurance claims data (n=592 456), the other data from the PRIoritising MUltimedication in Multimorbidity (PRIMUM) cluster randomised controlled trial (n=502). Population: ≥60 years, ≥5 drugs, ≥3 chronic diseases, excluding dementia. Outcomes: combined outcome of falls, hospitalisation, institutionalisation and nursing care needs (after 6, 9 and 24 months) (claims data); and HRQoL (after 6 and 9 months) (trial data). Predictor variables in both data sets: age, sex, morbidity-related variables (disease count), medication-related variables (European Union-Potentially Inappropriate Medication list (EU-PIM list)) and health service utilisation. Predictor variables exclusively in trial data: additional socio-demographics, morbidity-related variables (Cumulative Illness Rating Scale, depression), Medication Appropriateness Index (MAI), lifestyle, functional status and HRQoL (EuroQol EQ-5D-3L). Analysis: mixed regression models, combined with stepwise variable selection, 10-fold cross validation and sensitivity analyses. RESULTS: Most important predictors of EQ-5D-3L at 6 months in best model (Nagelkerke's R² 0.507) were depressive symptoms (-2.73 (95% CI: -3.56 to -1.91)), MAI (-0.39 (95% CI: -0.7 to -0.08)), baseline EQ-5D-3L (0.55 (95% CI: 0.47 to 0.64)). Models based on claims data and those predicting long-term outcomes based on both data sets produced low R² values. In claims data-based model with highest explanatory power (R²=0.16), previous falls/fall-related injuries, previous hospitalisations, age, number of involved physicians and disease count were most important predictor variables. CONCLUSIONS: Best trial data-based model predicted HRQoL after 6 months well and included parameters of well-being not found in claims. Performance of claims data-based models and models predicting long-term outcomes was relatively weak. For generalisability, future studies should refit models by considering parameters representing well-being and functional status.