Evaluation of patient engagement in medicine development: A multi-stakeholder framework with metrics.

BACKGROUND: Patient engagement is becoming more customary in medicine development. However, embedding it in organizational decision-making remains challenging, partly due to lack of agreement on its value and the means to evaluate it. The objective of this project was to develop a monitoring and evaluation framework, with metrics, to demonstrate impact and enhance learning. METHODS: A consortium of five patient groups, 15 biopharmaceutical companies and two academic groups iteratively created a framework in a multi-phase participatory process, including analysis of its application in 24 cases. RESULTS: The framework includes six components, with 87 metrics and 15 context factors distributed among (sub)components: (a) Input: expectations, preparations, resources, representativeness of stakeholders; (b) Activities/process: structure, management, interactions, satisfaction; (c) Learnings and changes; (d) Impacts: research relevance, study ethics and inclusiveness, study quality and efficiency, quality of evidence and uptake of products, empowerment, reputation and trust, embedding of patient engagement; (e) Context: policy, institutional, community, decision-making contextual factors. Case study findings show a wide variation in use of metrics. There is no 'one size fits all' set of metrics appropriate for every initiative or organization. Presented sample sets of metrics can be tailored to individual situations. CONCLUSION: Introducing change into any process is best done when the value of that change is clear. This framework allows participants to select what metrics they value and assess to what extent patient engagement has contributed. PATIENT CONTRIBUTION: Five patient groups were involved in all phases of the study (design, conduct, interpretation of data) and in writing the manuscript.

Does neighbourhood social capital aid in levelling the social gradient in the health and well-being of children and adolescents? A literature review.

BACKGROUND: Although most countries in the European Union are richer and healthier than ever, health inequalities remain an important public health challenge. Health-related problems and premature death have disproportionately been reported in disadvantaged neighbourhoods. Neighbourhood social capital is believed to influence the association between neighbourhood deprivation and health in children and adolescents, making it a potentially interesting concept for policymakers. METHODS: This study aims to review the role of social capital in health inequalities and the social gradient in health and well-being of children and adolescents. A systematic review of published quantitative literature was conducted, focussing on (1) the mediating role of neighbourhood social capital in the relationship between socio-economic status (SES) and health-related outcomes in children and adolescents and (2) the interaction between neighbourhood social capital and socio-economic characteristics in relation to health-related outcomes in children and adolescents. Three electronic databases were searched. Studies executed between 1 January 1990 and 1 September 2011 in Western countries (USA, New Zealand, Australia and Europe) that included a health-related outcome in children or adolescents and a variable that measured neighbourhood social capital were included. RESULTS: Eight studies met the inclusion criteria for the review. The findings are mixed. Only two of five studies confirmed that neighbourhood social capital mediates the association between neighbourhood deprivation and health and well-being in adolescents. Furthermore, two studies found a significant interaction between neighbourhood socio-economic factors and neighbourhood social capital, which indicates that neighbourhood social capital is especially beneficial for children who reside in deprived neighbourhoods. However, two other studies did not find a significant interaction between SES and neighbourhood social capital. Due to the broad range of studied health-related outcomes, the different operationalisations of neighbourhood social capital and the conceptual overlap between measures of SES and social capital in some studies, the factors that explain these differences in findings remain unclear. CONCLUSIONS: Although the findings of this study should be interpreted with caution, the results suggest that neighbourhood social capital might play a role in the health gradient among children and adolescents. However, only two of the included studies were conducted in Europe. Furthermore, some studies focussed on specific populations and minority groups. To formulate relevant European policy recommendations, further European-focussed research on this issue is needed.

Educational level and the quality of life of heart failure patients: a longitudinal study.

BACKGROUND: Lower education in heart failure (HF) patients is associated with high levels of anxiety, limited physical functioning, and an increased risk of hospitalization. We examined whether educational level is related to longitudinal differences in quality of life (QoL) in HF patients. METHODS AND RESULTS: This research is a substudy of the Coordinating study evaluating Outcomes of Advising and Counselling in Heart failure (COACH). QoL of 553 HF patients (mean age 69, 38% female, mean left ventricular ejection fraction 33%) was assessed during their hospitalization and at 4 follow-up measurements after discharge. In total 32% of the patients had very low, 24% low, 32% medium, and 12% high education. Patients with low educational levels reported the worst QoL. Significant differences between educational groups (P < .05) were only reported in physical functioning, social functioning, energy/fatigue, pain, and limitations in role functioning related to emotional problems. Longitudinal results show that a significantly higher proportion of high-educated patients improved in functional limitations related to emotional problems over time compared with lower-educated patients (P < .05). CONCLUSIONS: Patients with low educational levels reported the worst physical and functional condition. High-educated patients improved more than the other patients in functional limitations related to emotional problems over time. Low-educated patients may require different levels of intervention to improve their physical and functional condition.

Socioeconomic status and the course of quality of life in older patients with coronary heart disease.

BACKGROUND: Previous research suggests that socioeconomic status (SES) might be related to the course of quality of life (QoL) in coronary heart disease (CHD) patients. The authors sought to determine whether there are differences in the course of QoL before and after the incidence of CHD among older persons of differing SES. METHOD: Two hundred two CHD patients were followed up longitudinally using a community-based survey. Data on patients' QoL were collected before the diagnosis and at three follow-up assessments. RESULTS: High SES patients reported better outcomes at the premorbid assessment with fewer depressive feelings and better physical functioning. In physical functioning, similar results were repeated 6 and 12 months after the diagnosis. Additionally, high SES patients showed better role and social functioning 1 year after CHD. A multivariate analysis of variance revealed differential longitudinal pathways in relation to SES in role, social, and physical functioning. CONCLUSION: CHD modulates premorbid differences in depressive feelings. Conversely, high SES leads to better outcomes in all functional domains in the long-term after diagnosis. Postmorbid differences in physical functioning are not directly related to CHD, but rather the reestablishment of a premorbid situation. In contrast, socioeconomic inequalities in social and role functioning are a direct response to the impact of the disease.

A prospective study on educational level and adaptation to cancer, within one year after the diagnosis, in an older population.

Socio-economic status (SES) has often been associated with health disparities and mortality in cancer patients, yet systematic research into the role of SES in the course of the disease is lacking. This prospective study intends to examine the role of SES (i.e. educational level in this study) in psychological and physical adaptation to cancer. Ninety-nine cancer patients were followed from a community-based survey. Pre- and post-morbid data on patients' quality of life (QoL) were available. Adaptation was defined by looking at the level and pattern of scores on QoL scales from pre- to post-disease assessments. Results show some non-significant trends that more high-educated patients managed to adapt completely to cancer in relation to role and physical functioning when compared with low-educated participants. Furthermore, the greater part of high-educated patients who completely adapted in physical functioning achieved this result more rapidly without an initial deterioration. Unexpectedly, these differences were not significant when tested in a regression model. Hence, although there are some indications for differences in adaptation to role and physical functioning between educational groups, we did not find any evidence that proved such a relation. For the group as a whole, it is very interesting to see that based on our operationalization of adaptation, only a small percentage of patients deteriorated from pre- to post-disease assessments.

The mediating role of perceived control on the relationship between socioeconomic status and functional changes in older patients with coronary heart disease.

Using a prospective design, this study examines the mediating effect of perceived control in explaining the predictive role of socioeconomic status (SES) in long-term changes in functional status as a consequence of the occurrence of coronary heart disease (CHD). We followed 221 older CHD patients by using a community-based survey. We collected data on patients' functional status before the onset of disease and 1 year after the diagnosis. Multiple linear regressions show that SES predicts functional changes only in relation to physical functioning. Furthermore, self-efficacy, but not mastery, mediates the predictive role of SES in changes in physical functioning in CHD patients. Self-efficacy is the only aspect of control that mediates the relation between SES and changes in physical functioning. Our findings provide a basis for future interventions in disadvantaged groups of older persons and new theoretical models of recovery processes.

A European multi-language initiative to make the general population aware of independent clinical research: the European Communication on Research Awareness Need project.

BACKGROUND: The ECRAN (European Communication on Research Awareness Needs) project was initiated in 2012, with support from the European Commission, to improve public knowledge about the importance of independent, multinational, clinical trials in Europe. METHODS: Participants in the ECRAN consortium included clinicians and methodologists directly involved in clinical trials; researchers working in partnership with the public and patients; representatives of patients; and experts in science communication. We searched for, and evaluated, relevant existing materials and developed additional materials and tools, making them freely available under a Creative Commons licence. RESULTS: The principal communication materials developed were: 1. A website ( http://ecranproject.eu ) in six languages, including a Media centre section to help journalists to disseminate information about the ECRAN project 2. An animated film about clinical trials, dubbed in the 23 official languages of the European Community, and an interactive tutorial 3. An inventory of resources, available in 23 languages, searchable by topic, author, and media type 4. Two educational games for young people, developed in six languages 5. Testing Treatments interactive in a dozen languages, including five official European Community languages 6. An interactive tutorial slide presentation testing viewers' knowledge about clinical trials CONCLUSIONS: Over a 2-year project, our multidisciplinary and multinational consortium was able to produce, and make freely available in many languages, new materials to promote public knowledge about the importance of independent and international clinical trials. Sustained funding for the ECRAN information platform could help to promote successful recruitment to independent clinical trials supported through the European Clinical Research Infrastructure Network.