Yes / Introduction A key priority for the UK National Health Service and patients is to ensure that medicines are used safely and effectively. However, medication changes are not always optimally communicated and implemented when patients transfer from hospital into community settings. Heart failure is a common reason for admission to hospital. Patients with heart failure have a high burden of morbidity, mortality and complex pharmacotherapeutic regimens. The Improving the Safety and Continuity Of Medicines management at Transitions of care programme comprises a cluster randomised controlled trial which will test the effectiveness of a complex behavioural intervention aimed at improving medications management at the interface between hospitals discharge and community care. We will conduct a rigorous process evaluation to inform interpretation of the trial findings, inform implementation of the intervention on a wider scale and aid dissemination of the intervention. Methods and analysis The process evaluation will be conducted in six purposively selected intervention sites (ie, hospital trusts and associated community pharmacies) using a mixed-methods design. Fidelity and barriers/enablers of implementation of the Medicines at Transitions Intervention (MaTI) will be explored using observation, interviews (20 patients, 40 healthcare professionals), surveys and routine trial data collection on adherence to MaTI. A parallel mixed analysis will be applied. Qualitative data will be thematically analysed using Framework analysis and survey data will be analysed descriptively. Data will be synthesised, triangulated and mapped to the Consolidated Framework for Implementation Research where appropriate. The process evaluation commenced on June 2018 and is due to end on February 2021. Ethics and dissemination Approved by Research Ethics Committee and the UK Health Research Authority REC: 18/YH/0017/IRAS: 231 431. Findings will be disseminated via academic and policy conferences, peer-reviewed publications and social media. Trial registration number ISRCTN66212970.

Background: there is limited research to show that a social intervention such as increasing income improves health, especially as this relates to older people. It is known that poverty is a real problem for many older people in Northern Ireland. One reason for this is that older people often do not claim the financial benefits for which they are entitled. This is a randomised controlled study that sought to investigate the health effects of an increased uptake of social security benefits. Methods: The aims of this study were to find out if an increase in income through the take up of unclaimed financial benefits lead to a significant improvement in the health status of older people and discover if this was maintained over a reasonable period of time. This was a randomised control trial based in the community. Patients were recruited from 11 general practices in South Down, Craigavon, Fermanagh and Tyrone. The intervention consisted of a benefit assessment followed by assistance completing the benefit application. The control group received the assessment but were not give assistance with the application. Instead they were given a list of agencies where help with the application could be found. A range of health, psycho-social and financial outcome was measured. Results: Of the 2180 patients who were sent invitation letters 300 agreed to a benefits assessment. 189 enrolled in the study and 149 were followed up at six months. A total of 89 patients received additional weekly benefits amounting to approximately £3277.19 per annum (£63 per week). A further 13 patients received one off payments totaling £5,731.01. All but two patients received their benefits within three months of assessment. While analysis showed trends suggesting greater improvements in social support and depression scores for the intervention group when compared with the controls the difference were not statistically significant. This is probably due to the following factors. The sample size in this study was small because of problems with the recruitment and screening of patients. More patients in the control group claimed benefits than had been anticipated and as a result it was difficult to detect differences between the two groups. Discussion: Valuable lessons have been leant and modifications to the study methodology have been suggested that will be of use to other researchers attempting to undertake similar studies in the UK.

京都大学 / 新制・論文博士 / 博士(人間健康科学) / 乙第13615号 / 論人健博第15号 / 新制||人健||8(附属図書館) / 京都大学大学院医学研究科人間健康科学系専攻 / (主査)教授 梁 楠, 教授 黒木 裕士, 教授 松田 秀一 / 学位規則第4条第2項該当 / Doctor of Human Health Sciences / Kyoto University / DFAM

Impact evaluations in development interventions has been growing in recent years. The increasing demand for evidence-based outcomes has led to a debate of what methodology is best to evaluate the impact of development interventions. Accordingly, Randomised Controlled Trial (RCT) has been labeled as a gold standard for impact evaluations. The RCT method functions in a unique way, as it removes the selection bias and ensure high validity of a study. The aim of this research study is to critically assess the RCT as an alternative approach for impact assessment in relation to post-conflict countries; whether this claim holds in a conflict-affected environment or that the context-specific factors of post-conflict countries challenge the implementation of an RCT. This study implements mixed method approach by using simple descriptive statistics and semi-structured interview to answer the research questions. The findings of this study indicate that context-specific factors of post-conflict environments pose challenges on the implementation of an RCT.  As a result, these challenges threaten the quality of the RCT method which lies in reliability, internal validity and external validity. The findings also indicate that feasibility of RCT which lies in ethics, logistics and security, cannot be addressed individually, as the feasibility has a direct impact on the quality of the RCT method.

Many Low and Middle Income Countries (LAMICs) still lack sufficient health research capacity to build a local evidence-base with which to inform policy and improve population health. Recognising this, The 2013 World Health Report called for all nations to be producers of health research. To achieve this, new strategies that can develop sustainable locally-led capacity are required. Among the health research capacities needed, ability to conduct clinical trials is important. However, there is no evidence-informed guidance on the best ways to develop locally-led trial capacity. This thesis aims to fill this gap. Three cases-studies using qualitative methods to explore the barriers and enablers to locally-led trial conduct were conducted in Ethiopia, Cameroon and Sri Lanka. Current and potential local trial researchers and health research system stakeholders were recruited. A synthesis of the health research capacity development literature was conducted to compare the case-studies’ findings with wider published perspectives. These data permit an examination of the key issues facing the development of locally-led trial capacity in LAMICs. Barriers and enablers to locally-led trial conduct were found at macro, institutional and individual levels. Although different country research systems, and institutions and individuals within them, were variably successful at conducting trials, the key issues and mechanisms influencing successful trial undertaking were largely similar. Agreement among the case-studies and with the diverse literature suggests that many of the findings will be transferable to other LAMICs, and are also of relevance to other health research methods. A conceptual framework explaining the antecedents and consequences of locally-led trial undertaking in LAMICS is presented. This identifies the following factors as important for supporting locally-led trial undertaking: awareness and appreciation for health research and clinical trials; motivation to conduct clinical trials; availability of human resources with trial knowledge and technical skills; research leadership capabilities; ability to form collaborations, effective teams and acquire resources; trial management dedicated to sustainable capacity development and producing useful research; and system-wide prioritisation of health research. The theories of change presented within this framework are used to develop practical recommendations for development of locally-led trial capacity in LAMICs. These recommendations have four inter-related goals: fostering pro-research cultures in stakeholder institutions; developing trial leaders and staff; providing a facilitative operational environment for trials; and ensuring trial research has an impact. However, to create the will to enact change, advocacy from research champions and conducting trials in a way that benefits local institutions and population health is needed.