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Background Non-adherence to evidence based secondary prevention medicines (SPM) by coronary heart disease (CHD) patients limits their expected benefits and may result in a lack of improvement or significant deterioration in health. This study explored self-reported non-adherence to SPM, barriers to adherence, and the perception that patients in West Yorkshire have about their medicines in order to inform practice and improve adherence. Methods In this cross-sectional study a specially designed postal survey (The Heart Medicines Survey) assessed medicines-taking behaviour using the Morisky Medicines Adherence 8 items Scale (MMAS-8), a modified version of the Single Question Scale (SQ), the Adherence Estimator (AE), Beliefs about Medicines Questionnaire(BMQ) and additional questions to explore practical barriers to adherence. Patients were also asked to make any additional comments about their medicines-taking experience. A purposive sample of 696 patients with long established CHD and who were on SPM for at least 3 months was surveyed. Ethical approval was granted by the local ethics committee. Results 503 (72%) patients participated in the survey. 52%, 34% and 11% of patients were prescribed at least four, three and two SPMs respectively. The level of non-adherence to collective SPM was 44%. The AE predicted that 39% of those had an element of intentional non-adherence. The contribution of aspirin, statins, clopidogrel, beta blockers, angiotensin converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs) to overall non-adherence as identified by the SQ scale was 62%, 67%, 7%, 30%, 22% and 5%, respectively. A logistic regression model for overall non-adherence revealed that older age and female gender were associated with less non-adherence (OR = 0.96, 95% CI: 0.94, 0.98; OR = 0.56, 95% CI: 0.34, 0.93; respectively). Specific concern about SPM, having issues with repeat prescriptions and aspirin were associated with more non-adherence (OR = 1.12, 95% CI: 1.07, 1.18; OR = 2.48, 95% CI: 1.26, 4.90, OR = 2.22, 95% CI: 1.18, 4.17). Other variables were associated with intentional and non-intentional non-adherence. 221 (44%) patients elaborated on their medicines-taking behaviour by providing additional comments about the need for patient tailored information and better structured medicines reviews. Conclusions The Medicines Heart Survey was successful in revealing the prevalence of self-reported non-adherence and barriers to adherence in our population. Healthcare professionals should examine specific modifiable barriers to adherence in their population before developing interventions to improve adherence. Conducting frequent structured medicines-reviews, which explore and address patients' concerns about their medicines and healthcare services, and enable them to make suggestions, will better inform practice and may improve adherence.

Throughout the last decades, evolving treatment-opportunities provide a better chance of cure and thereby a higher percentage of patients is being treated for chronic disease (Robert Koch Institut, 2016). As treatment-toxicity, side effects and disease-derived symptoms remain high, it has become crucial to assesses parameters reflecting patients’ perspective, instead of solely focusing on illness-centered outcomes such as survival or treatment response. During the last decades, Patient-reported outcomes (PROs) are on the rise throughout research and cancer care as a key component to capture a patient’s perspective. This work illustrates the broad framework that PROs can be conducted in. We gathered experience and pioneered a systematic PRO-assessment in routine outpatient care, which continues to be updated. We identified a suitable PRO-based geriatric screening tool to avoid a time and resource consuming comprehensive geriatric assessment. Furthermore, we explored the beneficial effects of a PRO-based tailored intervention on HRQoL and provided effect-size estimations. Assessing PROs yields many benefits throughout the care pathway (Andreassen et al., 2006; Basch et al., 2016; Kofoed et al., 2012; Velikova et al., 2004; Yang et al., 2018) and was shown to be feasible in different entities and treatment setting (Bennett et al., 2016; M. K. Schuler et al., 2016; Strasser et al., 2016; Warrington et al., 2019). As a strikingly large discordance between patients’ and clinicians’ perception of symptoms exists (Atkinson et al., 2016), PROs can increase the accuracy of detection of adverse events and even predict survival (Efficace et al., 2021). Based on these advantages, the EMA and the FDA advocate the use of PROs as endpoints in cancer research (European Medicines Agency, 2016; U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research et al., 2006). Throughout previous years, methodological progress has been made resulting in elaborated measurement technics such as computerized adaptive testing being applied to PRO-instruments (Petersen et al., 2018, 2020). Clinical usability was increased with development of summary scores, cut-off values and emerging normative data (Giesinger et al., 2016, 2020). Interventions based on PROs are promising (Ishaque et al., 2019; Kotronoulas et al., 2014). Despite this ever increasing body of literature on PRO, a significant number of questions remain unanswered. Firstly, there was scarce knowledge about the benefits of a PRO-based intervention in sarcoma patients as there was limited PRO-data available in this entity. Sarcomas are rare diseases, still accounting for slightly less than 1% of all malignant neoplasia worldwide. The age adjusted incidence ranged from 7.4 per 100.000 men and 6.6 per women in Germany (Ressing et al., 2018). As sarcoma-treatment is improving, side-effects and toxicity remain to occur frequently (Gough et al., 2011; McDonough et al., 2019; Reichardt et al., 2012; Storey et al., 2019; Winnette et al., 2017). Until recently, there was quite limited knowledge about the patient-reported burden in terms of HRQoL, symptoms and psychological distress in patients with STS (Tang et al., 2012). PRO-based interventions yield beneficial effects in different cancer entities. Nevertheless, the effects of a PRO-based intervention in STS-patients was scarcely explored. The YonLife-Study (Publication B, Hentschel et al., 2020) contributes new evidence that a PRO-based intervention yields beneficial effects on HRQoL and suggests a positive, yet non-significant effect on survival. Concerning symptoms, the results of the YonLife-intervention remain far from being encouraging. As effects sizes are available now, RCTs which are powered to a confirmatory purpose could be performed in this population. Secondly, the importance of PROs are emphasized by authorities such as EMA or FDA that emphasize the need to incorporate PRO in scientific studies. Yet during the early 2010s, the actual incorporation of PROs in clinical routine was limited in Germany. We therefore designed and established a routine assessment of PROs (Publication C, (Trautmann, Hentschel et al., 2016) incorporating the automatized calculation, comparison with normative or threshold data and implemented it to our hospital information system. As until recently, feasibility data such for such an intervention is scarce, we collect measures of adherence, required time and barriers reported by staff. For the clinical benefit, the established PRO-assessment is being developed further and expanded to other departments and clinics of our institution. Thirdly, as numbers of geriatric cancer patients rise (Le Saux et al., 2019), older patients continue to be underrepresented in clinical trials (Singh et al., 2017), therefore an immense lack of knowledge on treatment-toxicities and side effects in this population exists. Treatment needs to be adapted to older patients frailty-level, which can be conducted applying a time- and resource consuming Comprehensive Geriatric Assessment (Le Saux et al., 2019). Still, there is no consensus on which domains to include and how to measure them (Hamaker, Jonker, et al., 2012). A geriatric screening can alleviate burden of conducting a whole CGA. Several screening instruments exists, yet there is inconsistent data (Kotzerke et al., 2019; Mohile et al., 2018; Soubeyran et al., 2014) which tool yields the best predictive performance. Our project aimed to compare three of the available screening tools (VES-13, G8, POT/CARG). Being far from having a perfect predictive performance, the POT/CARG occurs to be the screening instrument with a high sensitivity and sufficient negative predictive value. Furthermore, our research supports the increasing evidence that ultra-short-screeners such as ECOG state or age bear only insufficient predictive performance.:1. Introduction 1.1 What are Patient-reported outcomes (PROs)? 1.2 Assessment of PROs 1.2.1 Feasible in clinical routine, improving relevant outcomes 1.2.2 Improving diagnostic accuracy 1.2.3 Supporting drug development 1.2.4 Evolving measurement techniques and standardization 1.3 PRO-based feedback interventions 1.4 PRO-based geriatric screening 1.5 Research needs 1.5.1 Identifying a suitable geriatric screener 1.5.2 Limited PRO-data on Soft-Tissue Sarcoma (STS) patients 1.5.3 Feasibility-research in routine care 1.6 study aims 2. Methods 2.1 Design and Sample of Publication A 2.2 Design and Sample of Publication B 2.3 Design and Sample of Publication C 2.4 Instruments 2.5 Non-PRO-Outcomes 2.5.1 Predictive performance 2.5.2 Survival analysis 2.5.3 Feasibility analysis 2.6 Statistical Analysis 2.6.1 Sample Size Estimation 2.6.2 Non-participation and drop-out analysis 2.6.3 Regression Analyses 2.6.4 Statistical software 2.6.5 Statistical analysis plans 3. Outline of Publications Publication A Publication B Publication C 4. Discussion 4.1 Main findings, integration in existing research and research implications 4.1.1 Geriatric screening tools 4.1.2 PROs in soft tissue sarcoma (STS) 4.1.3 Implementation of PROs into routine care 4.2 Strengths and Limitations 4.2.1 Strengths 4.2.2 Limitations 5. Conclusions 6. Summary 7. References 8. Appendix 8.1 Darstellung des eigenen Beitrags 8.1.1 Darstellung des eigenen Beitrags zur Publikation A 8.1.2 Darstellung des eigenen Beitrags zur Publikation B 8.1.3 Darstellung des eigenen Beitrags zur Publikation C 8.2 Erklärung über die eigenständige Abfassung der Arbeit 8.3 Curriculum Vitae 8.4 Publikationsverzeichnis 8.5 Danksagung

Self-reported health is typically captured as a response to the question, “In general, would you rate your health as excellent, very good, good, fair or poor?” Among community-dwelling older adults (≥65 years), self-reported health decreases as the number of chronic conditions increases. Despite this well-documented relationship, little is known about how other sociodemographic or health-related factors may shape this relationship, what may predict high self-reported health among this population, or how older adults perceive these factors as influencing their perceptions of health. Informed by the Lifecourse Model of Multimorbidity Resilience, the objective of this multimethod research study was to advance understanding of self-reported health among community-dwelling older adults. To this end, four research studies were completed: 1) scoping review of the factors associated with self-reported health, 2) cross-sectional analysis of baseline data from the Canadian Longitudinal Study on Aging to understand the relationship between multimorbidity and self-reported health and the factors that predict high self-reported health; 3) qualitative case study to explore the influence of individual, social, and environmental factors on self-reported health, including multimorbidity resilience, in community-dwelling older adults, and; 4) a multimethod study that brought together all findings in a matrix analysis. From this work, two meta-inferences were generated: 1) the factors that shape self-reported health are multidimensional and complex; and 2) adaptation to health adversity, resulting from experiences acquired over the lifecourse, shape how older adults perceive their health. Findings from this work advance three implications. First, there is a need to use and apply information gained by asking about self-reported health in clinical practice to inform care planning. Second, there is a need for whole person care to guide health and social care policy for older adults. Third, future health research must further explore longitudinal understanding of self-reported health as well as additional qualitative understanding of the differences of those older adults with the well-being paradox. / Dissertation / Doctor of Philosophy (PhD)

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京都大学 / 新制・課程博士 / 博士(医学) / 甲第23790号 / 医博第4836号 / 新制||医||1057(附属図書館) / 京都大学大学院医学研究科医学専攻 / (主査)教授 山本 洋介, 教授 佐藤 俊哉, 教授 柳田 素子 / 学位規則第4条第1項該当 / Doctor of Medical Science / Kyoto University / DFAM