Kristina Johnell

Older adults have the highest risk of adverse drug events, yet they are regularly excluded from clinical trials where drug safety is evaluated. Apart from age restrictions in clinical trials, exclusion criteria often involve age-related factors such as co-morbidities and concomitant drug use. In this proposal, we aim to systematically evaluate drug safety in older adults using a wealth of European data. With the ultimate goal of producing real-world evidence that can influence regulatory agencies and improve drug safety in clinical practice.In this five-year project we intend to create an improved workflow for evaluating drug safety in older adults using data sources mapped to the OMOP Common Data Model as part of the European Health Data Evidence Network (EHDEN). The workflow will include a model for prioritization of medications for investigation. The model will target drugs used in regular practice, whereas new drugs will be evaluated as they reach the market. Second, we will contribute to the methodological development for integrating co-morbidities, concomitant drug use and frailty in real-world evidence studies of drug safety from routinely collected data. The analyses can be conducted in any of the Swedish register data sources we have direct access to, or within the ≈200 data partners in EHDEN.The findings will improve drug use in older adults, the part of the population with highest drug use and largest risk for adverse drug events.

Research problem and specific questionsMedications play an important role for the mental health and suicidal behaviour (i.e. suicide and self-harm) among older people. This is however an understudied topic, which we aim to change with the proposed project. We aim to investigate in older adults 1) Medication treatment before and after self-harm

2) Medication patterns before suicide

3) Medications, loneliness and bereavement

and 4) Co-designing prevention of suicidal behaviour and involuntary loneliness.Data and methodThe project combines quantitative analyses of high quality Swedish register data (Aim 1-3) with qualitative focus group interviews with key stakeholders (Aim 4). We will analyse longitudinal data from several Swedish registers of people aged ≥65 years (n≈3.1 million). Results from these analyses will serve as a foundation for the semistructured focus group interviews with key stakeholders, including user organisations, health care and eldercare.Relevance This multidisciplinary project integrates different research approaches and uses participatory designs, with the goal of co-designing preventive interventions for older adults. We will use cutting-edge epidemiological methods based on registers with excellent data quality offering the possibility for long-term follow-up. With these methodological advancements and big high quality data, we will be able to address the shortcomings of previous studies. This project will also identify vulnerable high-risk groups for tailored interventions that could increase health and autonomy in older adults.Our focus on medications in this context is novel and highly relevant. Medication treatment is very common among older adults and, thus, a natural point of intervention and potential identifier of loneliness and suicidal behaviour.Plan for project realisation We will start with the register-based studies (Aim 1-3) and the initiation of a Community Advisory Board of older adults. Based on the findings from Aim 1-3, we will design focus group interviews with key stakeholders (Aim 4). We will actively involve end users and health care and eldercare providers in the project to ensure that all important stakeholders are represented and provide input.Feasibility is ensured by availability of all necessary data in-house, and by the combined high and wide competence in our interdisciplinary team.The budget mainly covers funding for a PhD student and a postdoc for the scientific and outreach activities.