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Background Current approaches to identifying drug-drug interactions (DDIs), include safety studies during drug development and post-marketing surveillance after approval, offer important opportunities to identify potential safety issues, but are unable to provide complete set of all possible DDIs. Thus, the drug discovery researchers and healthcare professionals might not be fully aware of potentially dangerous DDIs. Predicting potential drug-drug interaction helps reduce unanticipated drug interactions and drug development costs and optimizes the drug design process. Methods for prediction of DDIs have the tendency to report high accuracy but still have little impact on translational research due to systematic biases induced by networked/paired data. In this work, we aimed to present realistic evaluation settings to predict DDIs using knowledge graph embeddings. We propose a simple disjoint cross-validation scheme to evaluate drug-drug interaction predictions for the scenarios where the drugs have no known DDIs. Results We designed different evaluation settings to accurately assess the performance for predicting DDIs. The settings for disjoint cross-validation produced lower performance scores, as expected, but still were good at predicting the drug interactions. We have applied Logistic Regression, Naive Bayes and Random Forest on DrugBank knowledge graph with the 10-fold traditional cross validation using RDF2Vec, TransE and TransD. RDF2Vec with Skip-Gram generally surpasses other embedding methods. We also tested RDF2Vec on various drug knowledge graphs such as DrugBank, PharmGKB and KEGG to predict unknown drug-drug interactions. The performance was not enhanced significantly when an integrated knowledge graph including these three datasets was used. Conclusion We showed that the knowledge embeddings are powerful predictors and comparable to current state-of-the-art methods for inferring new DDIs. We addressed the evaluation biases by introducing drug-wise and pairwise disjoint test classes. Although the performance scores for drug-wise and pairwise disjoint seem to be low, the results can be considered to be realistic in predicting the interactions for drugs with limited interaction information.

Background Diabetes-related lower extremity complications such as diabetic foot ulcer (DFU) are a global disability burden. Treatment and care for patients with DFU call for a multisectoral approach that incorporates interdisciplinary care pathways. We aimed to explore the interplay between patients with DFU and healthcare professionals in cross-sectoral settings that address treatment and care and to determine “ what works, for whom, and under what circumstances ”. Method The study was designed as a realistic evaluation. The data were generated from September 2022 to March 2023 and drew upon approximately 60 h of participant observation of 14 patients during the treatment and care of DFUs in their homes (primary care) and/or at outpatient clinics (wound specialist clinics in a hospital setting) in a Danish cross-sectoral setting. The Standards for Reporting Qualitative Research (SRQR) were applied in this study. Results We identified three illuminating themes that described the interplay between patients with DFU and related healthcare professionals representing both primary and secondary health care systems: (1) humour is a relationship-enhancing element between nurses and patients; (2) support from patients’ coping strategies promotes patient-centeredness and collaboration; and (3) patients and professionals occupy unnegotiated identity roles. Conclusion Our study led to a refined programme theory developed through the realistic evaluation process that allows us to propose an answer to the problem of “what works, for whom, and under what circumstances”. The interplay between patients with DFU and healthcare professionals in a cross-sectoral setting for treatment and care is characterised by the use of humour as a relation-enhancing element and by improving support for patient coping strategies, which encourages healthcare professionals to promote health literacy. Future research should examine strategies for negotiating identity roles between patients with DFU and healthcare professionals to enhance collaboration, patient health literacy, and health promotion in cross-sectoral healthcare settings.

Background The concept of distributed leadership has been addressed in previous research, but few studies link their analysis to current and comparative empirical studies on processes and conditions enabling or hindering the development of distributed leadership. This specific study aims to identify and analyze mechanisms that enable or hinder the development of distributed leadership among employees in eldercare. Methods This is a case study based on six specific workplaces in eldercare in Sweden in different ways aiming to work toward an organization that emphasizes trust and distribution of power. A realistic evaluation framework was used to understand the different workplace program theories regarding distributed leadership. Key mechanisms and how they interact with contextual factors in each case were analyzed. Comparative analyses were performed, identifying key processes in terms of realizing distributed leadership. Results Analyzing the program theories in the respective cases showed that they have different orientations influenced by different motives for distributed leadership, which also interact with how distributed leadership was manifested and realized. The results point specifically to the importance of the mechanism formalization processes, participatory approaches to implementation, vertical sense-making, and horizontal sense-making for the development of distributed leadership. Conclusions The result points to that regardless of the path for achieving distributed leadership adopted by the various workplaces studied, the common denominator for those succeeding in distributing leadership is the development of a relational agency based on shared visions, a shared understanding of roles, and responsibilities, a learning approach and a dialogue-oriented relationship between management and employees. Another critical aspect is having sufficient resources to make taking on more responsibilities attractive.

Background Evaluation frameworks are relevant to understanding health service providers’ views regarding existing services and possible improvements, but their application to mental health services is limited, particularly in Low Middle-Income Countries. Aim/question To identify a program theory that explains the contextual factors and mechanisms that could enhance mental health service outcomes in Ghana. Method A three-phase approach was followed: initial theory and assumption, analysis, and CMO configuration. Systematic reviews were used to develop a middle-range theory and assumptions in phase 1. A purposive sample of 30 mental health professionals was recruited to participate in in-depth interviews in phase 2. Thematic analysis was used to analyze the qualitative data and further configure the CMO in phase 3. Results The analysis identified five CMO configurations: ripple effects and financing source sustainability; unavailability of modern equipment and logistics to support holistic services; promoting inclusivity and geographical proximity of services; information, sensitization, and awareness encourage mental health quality; and monitoring and evaluation improve mental health service quality. Conclusion This study concludes that government stakeholders should integrate mental health services into the ongoing insurance policy and provide adequate modern equipment and logistics. Moreover, mechanisms and priorities given to vulnerable consumers should be integrated into policies.

Health mediation, similar to health navigation in the United States or Canada, is known by various terms worldwide. In France, health mediation has historically been implemented by civil society organizations to support hard-to-reach populations. Health mediation is increasingly considered by health authorities as a valuable tool for health promotion to reduce health inequalities. However, systematic evaluations of its effects are scarce, making it difficult for decision-makers to generalize health mediation as a health policy. Our study aims to bridge this gap, by framing a research protocol to evaluate a health mediation intervention. The intervention consists of setting up a biweekly mobile booth using an ‘outreach’ approach at the base of a social housing complex in 12 neighborhoods of Seine-Saint-Denis with marked indicators of social deprivation. We chose a realistic evaluation approach and a mixed-methods methodology, which is the best fit for assessing complex interventions such as the one we aim to assess. Realistic evaluation is a relatively new approach, and sharing studies based on this type of epistemological and methodological approach is required. This study aims to contribute to the reflection on and the production of standard tools to ensure that the use of this evaluation approach is improved.

Background Integrated knowledge translation (IKT) flows from the premise that knowledge co-produced with decision-makers is more likely to inform subsequent decisions. However, evaluations of manager/policy-maker-focused IKT often concentrate on intermediate outcomes, stopping short of assessing whether research findings have contributed to identifiable organisational action. Such hesitancy may reflect the difficulty of tracing the causes of this distal, multifactorial outcome. This paper elucidates how an approach based on realistic evaluation could advance the field. Main Text Realistic evaluation views outcomes as a joint product of intervention mechanisms and context. Through identification of context–mechanism–outcome configurations, it enables the systematic testing and refinement of ‘mid-range theory’ applicable to diverse interventions that share a similar underlying logic of action. The ‘context-sensitive causal chain’ diagram, a tool adapted from the broader theory-based evaluation literature, offers a useful means of visualising the posited chain from activities to outcomes via mechanisms, and the context factors that facilitate or disrupt each linkage (e.g. activity–mechanism, mechanism–outcome). Drawing on relevant literature, this paper proposes a context-sensitive causal chain by which IKT may generate instrumental use of research findings (i.e. direct use to make a concrete decision) and identifies an existing tool to assess this outcome, then adapts the chain to describe a more subtle, indirect pathway of influence. Key mechanisms include capacity- and relationship-building among researchers and decision-makers, changes in the (perceived) credibility and usability of findings, changes in decision-makers’ beliefs and attitudes, and incorporation of new knowledge in an actual decision. Project-specific context factors may impinge upon each linkage; equally important is the organisation’s absorptive capacity, namely its overall ability to acquire, assimilate and apply knowledge. Given a sufficiently poor decision-making environment, even well-implemented IKT that triggers important mechanisms may fall short of its desired outcomes. Further research may identify additional mechanisms and context factors. Conclusion By investigating ‘what it is about an intervention that works, for whom, under what conditions’, realistic evaluation addresses questions of causality head-on without sacrificing complexity. A realist approach could contribute greatly to our ability to assess – and, ultimately, to increase – the value of IKT.

Project SoL was implemented over a period of four years from 2012–2015 with the aim to promote healthy eating and physical activity among families with children aged 3–8 years, living in selected communities in two Danish municipalities. This was done by applying the supersetting approach to implement complex multi-component interventions in a participatory, coordinated, and integrated manner in childcare centres, schools, and supermarkets in three local communities, as well as in local media during a 19-month period in the Regional Municipality of Bornholm, which served as the intervention site. The matching municipality of Odsherred served as a control site based on its similarity to Bornholm regarding several socio-demographic and health indicators. The present paper describes the design of Project SoL as well as the processes of developing and implementing its complex interventions. Moreover, the theoretical and conceptual framework of the project is described together with its organisational structure, concrete activities, and sustainability measures. The paper discusses some of the key lessons learned related to participatory development and the implementation of a multi-component intervention. The paper concludes that coordinated and integrated health promotion activities that are implemented together with multiple stakeholders and across multiple settings in the local community are much more powerful than individual activities carried out in single settings. The supersetting approach was a useful conceptual framework for developing and implementing a complex multi-component health promotion intervention and for fostering ownership and sustainability of the intervention in the local community. The research and evaluation approach of the project is described in a separate paper (Part 2).

The aim of this study was to explore how a single-room hospital design influenced student nurses’ learning and competence development in clinical practice compared with shared-room accommodation, refining the programme theory: The student nurses’ conditions for learning in single-room hospital design are associated with the values of the patient room as the patient’s home during hospitalisation. It is evident that a hospital design with single-room accommodation influences several parameters for both the patients and staff. Furthermore, studies have shown that the physical as well as the psychological learning environment affects the learning outcome for student nurses. A premise for learning and education is that the physical learning space must promote person-centred and collaborative learning in order for the students to achieve their competence development goals. The study was conducted as a realistic evaluation that compares second and fifth-semester undergraduate nurses’ learning and competence development in clinical practice in shared accommodation (a pre-study) to single-room accommodation (a post-study). In the data generation, we drew on an ethnographically inspired participant observation method. We gathered data during the period 2019–2021, covering the time before and approximately one year after relocation to all single-room accommodation. We undertook 120 h of participant observation for the pre-study and 146 h of participant observation for the post-study. We conclude that the learning environment in a single-room accommodation setting promotes task-oriented practices where the patient is often a mediator of activities related to nursing care. The learning environment in single-room accommodation places increased demands on the students’ ability to reflect on verbal instructions on nursing activities whenever the chance for reflection presents itself. We also conclude that in a single-room accommodation setting, stakeholders must focus on conscious planning and follow-up on the student nurses’ learning and educational activities which must support the students’ competence development. Hence, summing up to a refined programme theory developed through the realistic evaluation process: The student nurse’s conditions for learning in a single-room hospital design are associated with increased demands on the student’s ability to reach out for professional reflection when the chance presents itself. This is because the value of the patient room as the patient’s home during hospitalisation promotes a task-solving approach to nursing with the patient and the patient’s relatives as instructors.

Background While interventions aimed at improving the food habits of people living with diabetes, obesity or hypertension have been implemented and proven effective, we know little about how they produce effects. To develop meaningful programs, it is essential to identify the elements that favor or prohibit successful outcomes and the mechanisms at work. Using a realist approach to evaluation, this study aimed to assess a diet support program offered by a community-based organization in the Greater Paris Region to disadvantaged women living with diabetes, obesity or hypertension. Methods We carried out a qualitative study using observations and semistructured interviews ( n  = 12) with women supported by the organization. The data were analyzed thematically and then cross-sectionally. The intervention-context-actor-mechanism-effect (ICAMO) configuration was used to structure the analysis and identify interactions between the various components. Results We identified three different types of effects: awareness of the importance of a balanced diet (cognitive change), initiation of changes in eating behavior, and significant changes in food habits. The mechanisms that led to these changes were based on empowerment (strengthening knowledge and skills, self-esteem, participation, and critical awareness). We also identified individual contextual factors that either limited changes in eating behavior (lack of financial resources, culinary habits) or facilitated them (having experienced a critical health event, access to a kitchen). Conclusion This study contributes to a better understanding of how support programs for eating behavior change work and can overcome the constraints faced by disadvantaged populations living with a chronic disease. The exploration of ICAMO configurations enables us to identify the intervention’s mechanisms and key characteristics that will be relevant to consider when replicating the program in other contexts or territories.

This study aimed to investigate students' learning journeys across the duration of a new registered nurse degree apprenticeship programme and to develop an understanding of the contextual factors, mechanisms and outcomes involved. Registered nurses are the largest group of healthcare workers globally, but shortages exist. To encourage existing UK healthcare employees into nursing, national investment was made into Registered Nurse Degree Apprenticeships. In 2018 a UK health service organisation and a university collaboration led to development of a nursing degree apprenticeship programme. Research into these novel undergraduate programmes in nursing is lacking, with scarce evidence or understanding of processes and experiences involved in such programmes. An exploratory qualitative design informed by realistic evaluation was employed. Three sequential semi-structured interviews were conducted with an entire cohort (n=8) across the 18-month programme (24 interviews). Focused interviews were also undertaken with practice assessors (n=8) involved in the apprentices' journey. Initial thematic analysis was followed by application of Realist Evaluation principles and a temporal lens to move beyond qualitative description. Analysis identified four interrelated temporal themes, each comprising contextual factors, mechanisms and outcomes acting to inhibit or facilitate transition across the apprenticeship journey: (1) Starting out (Latent Ambition, enhanced motivation and expectations): programme availability and conditions enabled enactment of ambitions to become qualified nurses, preconceived assumptions regarding roles influenced expectations. (2) Initial stages (Identity dissonance, transition to academia, becoming a student nurse) related to changing identity and re-conceptualisation of their role to student nurse, alongside transitioning into higher education. (3) Travelling through (Being an apprentice, social capital, self-efficacy and confidence) facilitated confident integration into placements, although over confidence could be risky. Academic struggles prompted some episodes of emotional dissonance. (4) Moving beyond to become registered nurses (Confidence, empowerment and loyalty in the transition to becoming a nurse) saw apprentices transform, with revised understandings of nursing, increased empowerment and self-efficacy. All expressed gratitude and loyalty for the apprenticeship opportunity, with all securing jobs in their employing organisation. This study is one of the first of its kind, providing detailed insight into processes experienced by students over the duration of a novel apprenticeship programme. Analysis identified several factors that facilitated and inhibited progress in participants' 'learning journeys', mapping context, mechanism, outcome configurations which came into play at various stages. These were influential in successful completion of the programme by all apprentices, resulting in the development of competent Registered Nurses.