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Background: The implementation science literature acknowledges a need for engagement of key stakeholders when designing, delivering and evaluating implementation work. To date, the literature reports minimal or focused stakeholder engagement, where stakeholders are engaged in either barrier identification and/or barrier prioritisation. This paper begins to answer calls from the literature for the development of tools and guidance to support comprehensive stakeholder engagement in implementation research and practice. The paper describes the systematic development of the Implementation‐STakeholder Engagement Model (I‐STEM) in the context of an international, large‐scale empirical implementation study (ImpleMentAll) aimed at evaluating the effectiveness of a tailored implementation toolkit. The I‐STEM is a sensitising tool that defines key considerations and activities for undertaking stakeholder engagement activities across an implementation process. Methods: In‐depth, semistructured interviews and observations were conducted with implementers who were tailoring implementation strategies to integrate and embed internet‐based cognitive behavioural therapy (iCBT) services in 12 routine mental health care organisations in nine countries in Europe and Australia. The analytical process was informed by principles of first‐ and third‐generation Grounded Theory, including constant comparative method. Results: We conducted 55 interviews and observed 19 implementation‐related activities (e.g., team meetings and technical support calls). The final outcome of our analysis is expressed in an initial version of the I‐STEM, consisting of five interrelated concepts: engagement objectives, stakeholder mapping, engagement approaches, engagement qualities and engagement outcomes. Engagement objectives are goals that implementers plan to achieve by working with stakeholders in the implementation process. Stakeholder mapping involves identifying a range of organisations, groups or people who may be instrumental in achieving the engagement objectives. Engagement approaches define the type of work that is undertaken with stakeholders to achieve the engagement objectives. Engagement qualities define the logistics of the engagement approach. Lastly, every engagement activity may result in a range of engagement outcomes. Conclusion: The I‐STEM represents potential avenues for substantial stakeholder engagement activity across key phases of an implementation process. It provides a conceptual model for the planning, delivery, evaluation and reporting of stakeholder engagement activities. The I‐STEM is nonprescriptive and highlights the importance of a flexible, iterative approach to stakeholder engagement. It is developmental and will require application and validation across a range of implementation activities. Patient or Public Contribution: Patient contribution to ImpleMentAll trial was facilitated by GAMIAN‐Europe at all stages—from grant development to dissemination. GAMIAN‐Europe brings together a wide variety of patient representation organisations (local, regional and national) from almost all European countries. GAMIAN‐Europe was involved in pilot testing the ItFits‐toolkit and provided their views on the various aspects, including stakeholder engagement. Patients were also represented in the external advisory board providing support and advice on the design, conduct and interpretation of the wider project, including the development of the ItFits‐toolkit. Trial registration: ClinicalTrials.gov NCT03652883. Retrospectively registered on 29 August 2018. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to explore whether positive impacts were sustained and unanticipated ripple effects had occurred four years after the implementation of interventions to improve cross‐cultural communication in primary care. Background: Sustaining the implementation of change using complex interventions is challenging. The EU‐funded "RESTORE" study implemented guidelines and training on cross‐cultural communication in five Primary Care sites in Europe, combining implementation theory (Normalisation Process Theory) with participatory methodology (participatory learning and action—PLA). There were positive impacts on knowledge, skills and clinical routines. Design, setting and participants: Four of the five original sites (England, Ireland, Greece, The Netherlands) were available for this qualitative follow‐up study. The study population (N = 44) was primary healthcare staff and migrants, most of whom had participated in RESTORE. Intervention; main outcome measures: PLA‐style focus groups and interviews explored routine practice during consultations with migrants. Etic cards based on the effects of RESTORE stimulated the discussion. Deductive framework analysis was performed in each country followed by comparative data analysis and synthesis. Results: Changes in knowledge, attitudes and behaviour with regard to consultations with migrants were sustained and migrants felt empowered by their participation in RESTORE. There were ongoing concerns about macro level factors, like the political climate and financial policies, negatively affecting migrant healthcare. Conclusion: There were sustained effects in clinical settings, and additional unanticipated positive ripple effects, due in part, from the participatory approach employed. [ABSTRACT FROM AUTHOR]

Background Pandemics of new and emerging infectious diseases are unpredictable, recurrent events that rapidly threaten global health and security. We aimed to identify public views regarding provision of information and consent to participate in primary and critical care clinical research during a future influenza-like illness pandemic. Methods Descriptive-interpretive qualitative study, using focus groups (n = 10) and semi-structured interviews (n = 16), with 80 members of the public (>18 years) in Belgium, Spain, Poland and the UK. Local qualitative researchers followed a scenario-based topic guide to collect data. Data were transcribed verbatim, translated into English and subject to framework analysis. Results Public understandings of pandemics were shaped by personal factors (illness during the previous H1N1 pandemic, experience of life-threatening illness) and social factors (historical references, media, public health information). Informants appreciated safeguards provided by ethically robust research procedures, but current enrolment procedures were seen as a barrier. They proposed simplified enrolment processes for higher risk research and consent waiver for certain types of low-risk research. Decision making about research participation was influenced by contextual, research and personal factors. Informants generally either carefully weighed up various approaches to research participation or responded instinctively. They supported the principle of using routinely collected, anonymized clinical biological samples for research without explicit consent, but regarded this as less acceptable if researchers were motivated primarily by commercial gain. Conclusions This bottom-up approach to ascertaining public views on pandemic clinical research has identified support for more proportionate research protection procedures for publically funded, low-risk studies. [ABSTRACT FROM AUTHOR]

Background: Subjective survival probabilities (SSPs) are considered relevant in relation to lifestyle as lifestyle improvements may improve health and lower mortality risk. Objective: To study individuals' SSP in a population of elderly (i.e. 60 years and older) from 15 European countries. Methods: Data from the second wave of the Survey of Health, Ageing and Retirement in Europe (SHARE) were used. Individuals were asked about their chances to live up to age [T] or more. These SSPs were related to general characteristics, health and lifestyle. In addition, cross‐country comparisons were made. The validity of the probabilistic elicitation format used for collecting SSPs was also addressed. Results: The average subjective probability of surviving the next 9–15 years was around 57%. Mean SSPs varied significantly across age, with lower means at higher ages. Cross‐country comparisons showed lowest mean in the Czech Republic (42%) and the highest in Denmark (64%). SSPs correlated with socio‐demographic, socio‐economic and also strongly with (objective) health characteristics except for obesity. Smokers reported significantly lower SSPs compared to non‐smokers, but no difference was found between non‐smokers and quitters. Excessive alcohol consumers reported significantly higher SSPs than moderate consumers and abstainers, but this only held for female excessive drinkers. Physical inactivity was negatively associated with SSPs, but this relation was attenuated at higher ages. In this context, important cross‐country differences were found. Conclusions: Subjective survival probabilities are informative and relevant in relation to lifestyle decisions and can be validly obtained in elder people. The results from this study provide interesting implications for health policy, health communication strategies and future research. [ABSTRACT FROM AUTHOR]

Background Inspired by American examples, several European countries are now developing disease management programmes (DMPs) to improve the quality of care for patients with chronic diseases. Recently, questions have been raised whether the disease management approach is appropriate to respond to patient-defined needs. Objective In this article we consider the responsiveness of current European DMPs to patients' needs defined in terms of multimorbidity, functional and participation problems, and self-management. Method Information about existing DMPs was derived from a survey among country-experts. In addition, we made use of international scientific literature. Results Most European DMPs do not have a solid answer yet to the problem of multimorbidity. Methods of linking DMPs, building extra modules to deal with the most prevalent comorbidities and integration of case management principles are introduced. Rehabilitation, psychosocial and reintegration support are not included in all DMPs, and the involvement of the social environment of the patient is uncommon. Interventions tailored to the needs of specific social or cultural patient groups are mostly not available. Few DMPs provide access to individualized patient information to strengthen self-management, including active engagement in decision making. Conclusion To further improve the responsiveness of DMPs to patients' needs, we suggest to monitor 'patient relevant outcomes' that might be based on the ICF-model. To address the needs of patients with multimorbidity, we propose a generic comprehensive model, embedded in primary care. A goal-oriented approach provides the opportunity to prioritize goals that really matter to patients. [ABSTRACT FROM AUTHOR]