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Aims: To investigate what it is about community-based perinatal mental health peer support from trained volunteers that works, for whom, in what circumstances, in what respects, and why; and build a change model that includes positive and negative mechanisms and outcomes., Methods: Realist evaluation methods based on semi-structured interviews were used to create a change model for a third sector programme in England., Results: Mothers who received peer support ( n  = 20), peer support volunteers ( n  = 27), and programme staff ( n  = 9) were interviewed. Positive impact on mothers was primarily based on feeling understood and accepted, social comparison (including normalisation, hope, and gaining perspective) and sharing non-directive information from experiential knowledge. Negative impact on mothers was based on negative social comparison, or absence of key peer support mechanisms. Mothers were affected in different ways, depending on individual contexts: their backgrounds, personalities, social situations, resources, experiences, beliefs, and needs. Some different mechanisms were present in one-to-one and group situations. All participants considered the benefits of peer support to greatly outweigh the risks., Conclusion: Individual contextual factors affect the multiple mechanisms through which mental health peer support can improve mothers' emotional wellbeing and social participation. Peer support has potential risks as well as benefits, which can be mitigated. Programmes could use this understanding of how contexts and mechanisms interact to produce peer support outcomes to improve training for peer support volunteers and to design future evaluations that take into account diversity of peer support experience.

Objective: Behaviour Change Communication (BCC) intervention programmes often lack documentation of successful processes. This manuscript aims to describe the development of Program Impact Pathway (PIP) using Theory of Change (ToC) approach for a mHealth BCC intervention titled 'Mobile Solutions Aiding Knowledge for Health Improvement (M-SAKHI)' aimed at reducing stunting in infants at 18 months of age., Design: The PIP was developed using ToC to design the intervention and plan its implementation. Literature review and data from previous pilots helped to identify health service gaps that needed to be addressed by the PIP of this intervention., Setting: M-SAKHI was implemented in 244 villages under governance of forty primary health centres of Nagpur and Bhandara districts of eastern Maharashtra in central India., Participants: The study investigators and the public health stakeholders participated in developing the PIP. M-SAKHI evaluation study recruited 2501 pregnant women who were followed up through delivery until their infants were 18 months old., Results: The PIP was developed, and it identified the following pathways for the final impact: (1) improving maternal and infant nutrition, (2) early recognition of maternal and infant danger signs, (3) improving access and utilisation to healthcare services, (4) improving hygiene, sanitation and immunisation practices, and (5) improving implementation and service delivery of community health workers through their training, monitoring and supervision in real time., Conclusion: This paper will illustrate the significance of development of PIP for M-SAKHI. It can aid other community-based programmes to design their PIP for nutrition-based BCC interventions.

Purpose: Community inclusion in research may increase the quality and relevance of research, but doing so in an equitable way is complex. Novel approaches used to build engagement with historically marginalized communities in other sectors may have relevance in the clinical research sector., Method: To address long-standing gaps and challenges, a stakeholder group was convened to develop a theory of change (ToC), a structured method for obtaining input from stakeholders to enhance the design, conduct, and dissemination of research. The stakeholder group, comprised of Black residents within a metropolitan area, followed a structured monthly meeting schedule for 12 months to produce an outcome map, a model that formally defines aspects of research and engagement for this community., Results: Stakeholders reported significant improvements in trust in and engagement with research over the 12-month period, but not changes in health empowerment (individual, organizational, or community level). Through this convening process, a ToC and outcome map were developed with the focus of building bidirectional relationships between groups identifying as Black, Indigenous, and People of Color (BIPOC) and researchers in Boston, MA. Additionally, the group developed a community ownership model and guidelines for researchers to adhere to when utilizing the ToC and outcome map with BIPOC communities., Conclusion: Co-ownership of models to develop bidirectional relationships between researchers and community members, such as the ToC and outcome map, may advance and further the value and reach of community-based participatory research while increasing levels of trust and engagement in research., Competing Interests: The authors declare none., (© The Author(s) 2024.)

Background: Mental health in the workplace is a growing concern for enterprises and policy makers. MENTUPP is a multi-level mental health intervention implemented in small and medium size enterprises from three work sectors in nine countries. This pilot study aimed to evaluate the feasibility, delivery, and instruments for the MENTUPP intervention to inform the planning of a clustered randomized controlled trial., Methods: We administered items from the Copenhagen Psychosocial Questionnaire and the Danish Work Environment Cohort Study measuring psychosocial workplace factors. The questionnaire was answered by 382 participants at baseline, of which 98 participants also answered after six months at follow-up. We calculated mean scores of 19 psychosocial factors at baseline and conducted repeated measures ANOVAs to assess differences in eight psychosocial factors at follow-up. We also examined whether outcomes differed between work sectors and job positions at follow-up., Results: The construction sector and workers with no or a lower leadership role reported more negative working environment factors at baseline. We observed a statistically significant decline in social support from colleagues and social community at work, and a marginally significant decline in justice at work. For the rest of the constructs, we did not observe statistically significant changes., Conclusions: We found significant differences in psychosocial work environment factors among work sectors and job positions at baseline. Contrary to our hypotheses, three psychosocial work environment factors decreased at follow-up. Possible explanations are the utilization of specific psychosocial factors as resources to cope with psychosocial stressors, high participant expectations that were not met by the intervention, insufficient time for structural changes, or the intervention prompting critical evaluations of the work environment. These findings will inform the design and implementation of the forthcoming clustered randomized controlled trial, where they will also be further investigated to validate their significance., (© 2024. The Author(s).)

In response to China's incentive for "connotative development" in doctoral education, universities are actively fostering creative and innovative PhD candidates with enhanced research productivity and superior educational quality. A Chinese university, aligning with this objective, has initiated significant reforms in its doctoral admission methods, introducing a new type of student and altering the proportion of existing ones. Recognizing the complexity and uncertainty inherent in the doctoral admission process, this theory-based study employs a Theory of Change framework to systematically evaluate the immediate, intermediate, and long-term outcomes of this university's interventions. It assesses the transformative impact of these changes by integrating secondary data with qualitative insights, including focus group discussions with twelve students and semi-structured interviews with three supervisors. The study reveals that while this university has made substantial progress in achieving short-term goals, these reforms have not uniformly benefited all student categories, presenting distinct challenges and opportunities for stakeholders. Consequently, it advocates for diversifying the student composition and emphasizes inclusive pedagogical strategies to facilitate high-quality doctoral education. Importantly, this research extends beyond this university, promoting a balanced mix of student profiles and a holistic approach to shaping effective policies and practices within doctoral admission, essential for navigating global competition., Competing Interests: Declaration of Competing Interest None., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

In Ghana, a severe mental healthcare gap of 95-98% exists due to limited services. Ghana Somubi Dwumadie set out to address this by developing district mental healthcare plans (DMHPs) in three demonstration districts. Following the Programme for Improving Mental Healthcare model, district mental health operations teams were formed and used Theory of Change (ToC) to develop DMHPs. Key elements included training non-specialist health workers and enrolling individuals in relevant healthcare programmes. Evaluation methods included routine data, health facility surveys, and qualitative analysis within the ToC framework. Results showed improved integration of mental health services, enhanced case management through training, and increased service utilisation, shown through 691 service user enrollments. However, there was limited commitment of new resources and no significant improvement in primary care workers' capacity to detect priority mental health conditions. The study concludes that DMHPs, implemented with an integrated approach, can improve mental health service utilisation, contingent on committed leadership, resource availability, and stakeholder engagement., (© 2024. The Author(s).)

Background: Sedentary behaviour and physical inactivity are independent risk factors for sarcopenia for long-term care facility residents. Understanding the components, mechanisms and context of interventions that target change in these risk factors can help optimize sarcopenia management approaches. This study aimed to identify, appraise and synthesize the interventions targeting sedentary behaviour and physical inactivity, construct a Theory of Change logic model, inform complex sarcopenia intervention development and identify areas for improvement., Methods: Eight electronic databases, including Embase and Web of Science, were searched for eligible interventional studies from inception until February 2024. Narrative synthesis was used. The Theory of Change was applied to develop a logic model presenting the synthesized results. A Cochrane risk of bias assessment tool was used for quality appraisal., Results: The study included 21 articles involving 1014 participants, with mean ages ranging from 72.5 to 90.4 years. The proportion of female participants ranged from 8.0% to 100.0%. The applied sarcopenia diagnosis criteria varied, including those of the Asian Working Group for Sarcopenia and the European Working Group on Sarcopenia in Older People. The overall risk of bias in the included studies was moderate. Interventions primarily targeted physical inactivity, with resistance training being the most common intervention type. The reporting of intervention adherence was insufficient (only 11 out of 21 included studies provided adherence reports), and adherence overall and by intervention type was not possible to discern due to inconsistent criteria for high adherence across these studies. Four categories of intervention input were identified: educational resources; exercise equipment and accessories; monitoring and tailoring tools; and motivational strategies. Intervention activities fell into five categories: determining the intervention plan; educating; tailoring; organizing, supervising, assisting and motivating; and monitoring. While sarcopenia-related indicators were commonly used as desired outcomes, intermediate outcomes (i.e., sedentary time and physical activity level) and other long-term outcomes (i.e., economic outcomes) were less considered. Contextual factors affecting intervention use included participant characteristics (i.e., medical condition and education level) and intervention provider characteristics (i.e., trustworthiness)., Conclusions: The findings led to the development of a novel logic model detailing essential components for interventions aimed at managing sarcopenia in long-term care facilities, with a focus on addressing sedentary behaviour and physical inactivity. Future sarcopenia interventions in long-term care facilities should fully attend to sedentary behaviour, enhance adherence to interventions through improved education, monitoring, tailoring and motivation and establish an agreed standard set of outcome measures., (© 2024 The Author(s). Journal of Cachexia, Sarcopenia and Muscle published by Wiley Periodicals LLC.)

Background: In this article we analyzed the extent of the usage of Theories of Change (TOCs) and causal pathways in the evaluation of immunization programs to identify the challenges to generating evidence on how interventions improve immunization., Methods: We analyzed the use of the TOC in impact evaluations (IEs) of immunization interventions published after 2010, and its associated articles. The review includes studies from Evidence Gap Map and Yale review that were conducted in May and March of 2020, respectively. We synthesized data on six domains using NVIVO - program theory, context, assumptions, usage of TOC, use in evaluation, and description causal pathways., Results: Our review included 47 large-scale and 45 small-to medium-scale interventions. Of the included studies, 19% used a TOC, 56% described a causal pathway or used a conceptual diagram with varying degrees of detail, and 25% of the IEs did not provide any information on how their intervention was expected to affect change. Only 19 of the 92 IEs explicitly outlined any assumptions associated with the implementation of the interventions. Forty studies measured the outputs or intermediate outcomes leading to improved immunization coverage., Conclusion: Future implementers and evaluators need to develop clear TOCs that are based on established theory and have clearly articulated the underlying assumptions. Large-scale health system strengthening initiatives implemented by governments, also need to build TOCs and integrate them into their results frameworks. Additionally, there is a need to combine both impact and process evaluations to understand the how context affects the causal pathways., (© 2024. The Author(s).)

Sex and gender are inadequately considered in health and medical research, policy and practice, leading to preventable disparities in health and wellbeing. Several global institutions, journals, and funding bodies have developed policies and guidelines to improve the inclusion of diverse participants and consideration of sex and gender in research design and reporting and the delivery of clinical care. However, according to recent evaluations, these policies have had limited impact on the inclusion of diverse research participants, adequate reporting of sex and gender data and reducing preventable inequities in access to, and quality provision of, healthcare. In Australia, the Sex and Gender Policies in Medical Research (SGPMR) project aims to address sex and gender bias in health and medical research by (i) examining how sex and gender are currently considered in Australian research policy and practice; (ii) working with stakeholders to develop policy interventions; and (iii) understanding the wider impacts, including economic, of improved sex and gender consideration in Australian health and medical research. In this paper we describe the development of a theory of change (ToC) for the SGPMR project. The ToC evolved from a two-stage process consisting of key stakeholder interviews and a consultation event. The ToC aims to identify the pathways to impact from improved consideration of sex and gender in health and medical research, policy and practice, and highlight how key activities and policy levers can lead to improvements in clinical practice and health outcomes. In describing the development of the ToC, we present an entirely novel framework for outlining how sex and gender can be appropriately considered within the confines of health and medical research, policy and practice., (© 2024. The Author(s).)

Engaging young people in health research has been promoted globally. We explored the outcomes of youth advisory group on health and research engagement (YAGHRE) in rural Cambodia. In May 2021, the Mahidol Oxford Tropical Medicine Research Unit (MORU) partnered with a local health centre and a secondary school to establish a youth engagement group. Ten students underwent training and led health engagement activities in schools and communities. Activities were documented as field notes and audio-visual materials which underwent content analysis using theory of change supplemented by iterative discussions with YAGHRE members and stakeholders. Five major outcomes were identified: 1. Increased respect . Engagement activities developed based on input from students and stakeholders may have fostered greater respect. 2. Built trust and relationships . Frequent visits to MORU's laboratory and interactions with researchers appeared to contribute to the building of trust and relationship. 3. Improved health and research literacy . Learning new health and research topics, through participatory activities may have improved literacy; 4. Improved uptake of health and research interventions . Health promotional activities and communication with research participants potentially increased the uptake of interventions; 5. Improved community health . YAGHRE's health promotional interventions may have contributed in enhancing community's health., Competing Interests: No potential conflict of interest was reported by the author(s)., (© 2024 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.)

The primary objective of transdisciplinary research (TDR) is to contribute to the solution of complex 'real-world' problems by integrating heterogeneous knowledge and achieving societal effects. However, establishing a continuous impact orientation during TDR processes remains a challenge, as the necessary tools are not yet sufficiently available. We developed and tested a half-day workshop format for strengthening the impact-oriented project management and research activities of seven TDR projects. Our findings indicate that the reflective impact workshops supported participants in pursuing societal effects systematically. Applying the methodological approach also fosters TDR process qualities such as knowledge integration. Conducted at different project stages, the results can serve as a basis for monitoring and adapting the project design. The reflective approach•includes scientific and non-scientific TDR project team members,•draws on Theory of Change as a conceptual framework and motivates participants to reflect on plausible impact pathways and make implicit assumptions about interlinkages between different forms of societal effects explicit, and•provides results which enable project partners to adjust their project design for greater societal effectiveness., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 The Authors. Published by Elsevier B.V.)

Policy Points Faced with urgent threats to human health and well-being such as climate change, calls among the academic community are getting louder to contribute more effectively to the implementation of the evidence generated by our research into public policy. As interest in knowledge translation (KT) surges, so have a number of anxieties about the field's shortcomings. Our paper is motivated by a call in the literature to render useful advice for those beginning in KT on how to advance impact at a policy level. By integrating knowledge from fields such as political science, moral psychology, and marketing, we suggest that thinking and acting like marketers, lobbyists, movements, and political scientists would help us advance on the quest to bridge the chasm between evidence and policy., (© 2024 The Authors. The Milbank Quarterly published by Wiley Periodicals LLC on behalf of The Milbank Memorial Fund.)

Although there is growing global momentum behind food systems strategies to improve planetary and human health-including nutrition-there is limited evidence of what types of food systems interventions work. Evaluating these types of interventions is challenging due to their complex and dynamic nature and lack of fit with standard evaluation methods. In this article, we draw on a portfolio of 6 evaluations of food systems interventions in Africa and South Asia that were intended to improve nutrition. We identify key methodological challenges and formulate recommendations to improve the quality of such studies. We highlight 5 challenges: a lack of evidence base to justify the intervention, the dynamic and multifaceted nature of the interventions, addressing attribution, collecting or accessing accurate and timely data, and defining and measuring appropriate outcomes. In addition to more specific guidance, we identify 6 cross-cutting recommendations, including a need to use multiple and diverse methods and flexible designs. We also note that these evaluation challenges present opportunities to develop new methods and highlight several specific needs in this space., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction: Due to advances in treatments, people with haemophilia (PWH) are living longer. They are not as active as the general population due to joint damage and lack confidence to be active due to concerns about further bleeds and pain. There is a need to facilitate healthy aging through promotion of physical activity (PA) and exercise. Changing patient beliefs and increasing physical literacy and confidence to move are thought to be key to helping PWH become more active., Aim: This paper describes the development of an exercise and behaviour change intervention to improve confidence to exercise in PWH., Methods: The 4-stage Medical Research Council framework for complex intervention development was used., Results: Stakeholders included 17 PWH and 7 physiotherapists working in haemophilia. Seven online focus group meetings were held. The final intervention is a hybrid 12-week physiotherapist led progressive exercise programme. Classes are 45 min including Pilates, High intensity interval training and balance elements, together with discussion sessions focusing on PA recommendations, the types and benefits of different exercise styles and the effects of PA, together with the effects of aging for PWH. The COM-B model of behaviour change was used to develop the intervention., Conclusion: Co-design helps to produce an intervention that understands the stakeholders needs. Through this process the intervention developed to incorporate not only increasing PA but also confidence to exercise. The use of behaviour change theory identified the behaviour techniques included in the intervention and aims to increase physical literacy in this population., (© 2024 The Authors. Haemophilia published by John Wiley & Sons Ltd.)

Aim: The aim of this study is to further develop a preliminary framework into a model that can translate mechanisms into output and impact, based on the views of those working in practice and the relations between the mechanisms: a model that can inform practitioners and organizations on what has to be in place to shape a learning and innovating environment in nursing., Background: A Learning and Innovation Network (LIN) is a network of healthcare professionals, students and education representatives who come together to be part of a nursing community to integrate education, research and practice to contribute to quality of care. In a previous study a preliminary framework was developed through a concept analysis based on publications. The preliminary framework describes input, throughput and output factors in a linear model that does not explain what the components entail in practice and how the components work together., Design: Focus groups., Methods: We designed a Theory of Change (ToC) in four phases. This was based on a focus group interview with lecturer practitioners (Phase 1); a first concept ToC based on thematic analysis of the focus group interview (Phase 2); three paired interviews where the ToC was presented to other lecturer practitioners to complement and verify the ToC model (Phase 3); and adjustment of the model based on the feedback of phase 3 (Phase 4)., Results: The developed ToC model describes important preconditions that have to be in place to start a LIN: a shared vision, a facilitating support system and a diversity of participants who are open to change. It describes the mechanisms by which a wide range of activities can lead to an improvement of the quality of care through collaboration between practice, education and research by working, learning, performing practice based research and implementing new methods together., Conclusion: This study gives a comprehensive overview of the concept of the 'Learning and Innovation Network' (LIN); how the activities in the LIN can lead to impact; and under what conditions. Previously published findings supported elements of the ToC model. The overarching ToC model and the detailed appendix offer a theoretical and practice-based model for practitioners, managers and policy makers., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Stakeholder engagement is essential to the design, implementation and evaluation of complex mental health interventions like peer support. Theory of Change (ToC) is commonly used in global health research to help structure and promote stakeholder engagement throughout the project cycle. Stakeholder insights are especially important in the context of a multi-site trial, in which an intervention may need to be adapted for implementation across very different settings while maintaining fidelity to a core model. This paper describes the development of a ToC for a peer support intervention to be delivered to people with severe mental health conditions in five countries as part of the UPSIDES trial., Methods: One hundred thirty-four stakeholders from diverse backgrounds participated in a total of 17 workshops carried out at six UPSIDES implementing sites across high-, middle- and low-income settings (one site each in India, Israel, Uganda and Tanzania; two sites in Germany). The initial ToC maps created by stakeholders at each site were integrated into a cross-site ToC map, which was then revised to incorporate additional insights from the academic literature and updated iteratively through multiple rounds of feedback provided by the implementers., Results: The final ToC map divides the implementation of the UPSIDES peer support intervention into three main stages: preparation, implementation, and sustainability. The map also identifies three levels of actors involved in peer support: individuals (service users and peer support workers), organisations (and their staff members), and the public. In the UPSIDES trial, the ToC map proved especially helpful in characterising and distinguishing between (a) common features of peer support, (b) shared approaches to implementation and (c) informing adaptations to peer support or implementation to account for contextual differences., Conclusions: UPSIDES is the first project to develop a multi-national ToC for a mental health peer support intervention. Stakeholder engagement in the ToC process helped to improve the cultural and contextual appropriateness of a complex intervention and ensure equivalence across sites for the purposes of a multi-site trial. It may serve as a blueprint for implementing similar interventions with a focus on recovery and social inclusion among people with mental ill-health across diverse settings., Trial Registration: ISRCTN26008944 (Registration Date: 30/10/2019)., (© 2024. The Author(s).)

Objective: To adapt an evidence-based psychological intervention for pregnant women experiencing depressive symptoms and intimate partner violence (IPV) in rural Ethiopia., Method: We conducted a desk review of contextual factors in Sodo, Ethiopia, followed by qualitative interviews with 16 pregnant women and 12 antenatal care (ANC) providers. We engaged stakeholders through participatory theory of change (ToC) workshops, to select the intervention and articulate a programme theory. We used "ADAPT" guidance to adapt the intervention to the context, before mapping potential harms in a "dark logic model"., Results: Brief problem-solving therapy developed for South Africa was the most contextually relevant model. We adapted the delivery format (participants prioritised confidentiality and brevity) and training and supervision (addressing IPV). Consensus long-term outcomes in our ToC were ANC providers skilled in detecting and responding to emotional difficulties and IPV, women receiving appropriate support, and emotional difficulties improving. Our dark logic model highlighted the risk of more severe IPV and mental health symptoms not being referred appropriately., Conclusion: Although intervention adaptation is recommended, the process is rarely reported in depth. We comprehensively describe how contextual considerations, stakeholder engagement, programme theory, and adaptation can tailor psychological interventions for the target population in a low-income, rural setting.

Theory of change (ToC) is an approach widely used to guide planning, implementing, and evaluating change initiatives. While there is substantial guidance, there has been little attention on equity within ToC research and practice. We propose and illustrate the metaphor of 'knots' to frame practical and ethical challenges that arise when centering equity within ToC processes. Drawing on our experiences using a ToC approach in two case examples, we identify and illustrate five equity-related knots: (a) clarify root causes, pathways, and success; (b) facilitate participation across power and perspective differences; (c) integrate research evidence and practitioner knowledge; (d) represent complex change visually; and (e) creatively navigate constraints. We show why framing these as knots can help practitioners make wise judgments within the circumstances and close with recommendations for including knots in ToC processes, reporting, and guidance., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

In conflict-affected settings, prevalence of alcohol use disorders (AUDs) can be high. However, limited practical information exists on AUD management in low-income settings. Using a theory of change (ToC) approach, we aimed to identify pathways influencing the implementation and maintenance of a new transdiagnostic psychological intervention ("CHANGE"), targeting both psychological distress and AUDs in humanitarian settings. Three half-day workshops in Uganda engaged 41 stakeholders to develop a ToC map. ToC is a participatory program theory approach aiming to create a visual representation of how and why an intervention leads to specific outcomes. Additionally, five semi-structured interviews were conducted to explore experiences of stakeholders that participated in the ToC workshops. Two necessary pathways influencing the implementation and maintenance of CHANGE were identified: policy impact, and mental health service delivery. Barriers identified included policy gaps, limited recognition of social determinants and the need for integrated follow-up care. Interviewed participants valued ToC's participatory approach and expressed concerns about its adaptability in continuously changing contexts (e.g., humanitarian settings). Our study underscores ToC's value in delineating context-specific outcomes and identifies areas requiring further attention. It emphasizes the importance of early planning and stakeholder engagement for sustainable implementation of psychological interventions in humanitarian settings., Competing Interests: The authors declare that they have no competing interests., (© The Author(s) 2024.)

The project 'Quality Decision-making by women and providers' (QUALI-DEC) combines four non-clinical interventions to promote informed decision-making surrounding mode of birth, improve women's birth experiences, and reduce caesarean sections among low-risk women. QUALI-DEC is currently being implemented in 32 healthcare facilities across Argentina, Burkina Faso, Thailand, and Viet Nam. In this paper, we detail implementation processes and the planned process evaluation, which aims to assess how and for whom QUALI-DEC worked, the mechanisms of change and their interactions with context and setting; adaptations to intervention and implementation strategies, feasibility of scaling-up, and cost-effectiveness of the intervention. We developed a project theory of change illustrating how QUALI-DEC might lead to impact. The theory of change, together with on the ground observations of implementation processes, guided the process evaluation strategy including what research questions and perspectives to prioritise. Main data sources will include: 1) regular monitoring visits in healthcare facilities, 2) quantitative process and output indicators, 3) a before and after cross-sectional survey among post-partum women, 4) qualitative interviews with all opinion leaders, and 5) qualitative interviews with postpartum women and health workers in two healthcare facilities per country, as part of a case study approach. We foresee that the QUALI-DEC process evaluation will generate valuable information that will improve interpretation of the effectiveness evaluation. At the policy level, we anticipate that important lessons and methodological insights will be drawn, with application to other settings and stakeholders looking to implement complex interventions aiming to improve maternal and newborn health and wellbeing. Trial registration : ISRCTN67214403.

Background: Improved approaches for chronic pain management are a clinical and research priority for people with haemophilia (PWH). Involving people with lived experience in the design of a complex rehabilitation intervention strengthens the credibility and plausibility of the intervention, particularly in relation to rare disorders. Here we describe using a 'Theory of Change' (ToC) dialogue-based stakeholder process to create a programme theory for a telerehabilitation intervention., Methods: An online workshop was convened and stakeholders received a briefing document in advance. Five stakeholders took part (3 PWH and 2 physiotherapists). At the workshop the group first agreed the overall aim of the intervention. Discussions then identified the resources, activities, barriers and enablers needed to achieve this outcome. All discussions were recorded and annotated by the workshop moderator. Behaviour change techniques were mapped for inclusion in the theory., Results: A programme theory and narrative report were produced. All stakeholders reviewed these for clarity and to ensure a true reflection of the workshop discussions. Agreement was based on how meaningful, well-defined, do-able, plausible, credible, and testable each component was. Stakeholders highlighted the importance of issues unique to PWH. Key components included the need for physiotherapists to be knowledgeable of the condition, a range of exercises that were inclusive of all abilities, and the need for people to feel safe and supported whilst taking part., Conclusions: Co-developed theory based approaches to intervention design offer an inclusive and transparent way to develop novel and meaningful interventions for people with complex health conditions. The ToC is wholly transparent in its design and content. Together with the identified behaviour change techniques, the theory informs the protocol for a feasibility study evaluating a telerehabilitation intervention. Importantly, it allows the opportunity to revise, adapt and improve the programme theory for further implementation and evaluation., (© 2023. The Author(s).)

Background: Maternal mortality remains stubbornly high in Ghana. Current national efforts are focused on improving the quality of care offered in health facilities. Obstetric triage is one intervention that has been proposed to improve the timeliness and appropriateness of care, two key elements of quality. In this study, we describe and evaluate a theory-based implementation approach to introduce obstetric triage into Tema General Hospital, a high-volume maternity hospital in Greater Accra, that blends concepts from implementation science and quality improvement. This implementation project was a first attempt to scale this intervention into a new facility, following initial development in the Greater Accra Regional Hospital (formerly Ridge Hospital) in Accra., Methods: This was a retrospective mixed-methods evaluation of two stages of implementation: active implementation and sustainment. We triangulated monitoring data captured during active implementation with clinical outcome data (timeliness of first assessment, accuracy of diagnosis, and appropriateness of care plan) from direct observation or patient obstetric triage assessment forms at baseline, at the completion of the active implementation stage, and following a 12-month "washout" period with no contact between hospital staff and the purveyor organization. Finally, we assessed embeddedness of the new triage procedures using the NoMad, a quantitative assessment of constructs from normalization process theory (NPT)., Results: Patient waiting time decreased substantially during the study. At baseline, the median arrival-to-assessment waiting time was 70.5 min (IQR: 30.0-443.0 min). Waiting time decreased to 6.0 min (IQR: 3.0-15.0 min) following active implementation and to 5.0 min (IQR: 2.0-10.0 min) during the sustainment period. Accuracy of diagnosis was high at the end of active implementation (75.7% correct) and improved during the sustainment period (to 77.9%). The appropriateness of care plans also improved during the sustainment period (from 66.0 to 78.9%). Per NoMad data, hospital staff generally perceive obstetric triage to be well integrated into the facility., Conclusions: This theory-based implementation approach proved to be successful in introducing a novel obstetric triage concept to a busy high-volume hospital, despite resource constraints and a short implementation window. Results proved long-lasting, suggesting this approach has high potential for engendering sustainability in other facilities as well. Our approach will be useful to other initiatives that aim to utilize program data to create and test implementation theories., (© 2023. The Author(s).)

Background: Common challenges in the youth mental health system include low access, poor uptake, poor adherence, and limited overall effectiveness. Digital technologies offer promise, yet challenges in real-world integration and uptake persist. Moderated Online Social Therapy (MOST) aims to overcome these problems by integrating a comprehensive digital platform into existing youth mental health services. Theory of change (ToC) frameworks can help articulate how and why complex interventions work and what conditions are required for success., Objective: The objective of this study is to create a ToC for MOST to explain how it works, why it works, who benefits and how, and what conditions are required for its success., Methods: We used a multimethod approach to construct a ToC for MOST. The synthesis aimed to assess the real-world impact of MOST, a digital platform designed to enhance face-to-face youth mental health services, and to guide its iterative refinement. Data were gathered from 2 completed and 4 ongoing randomized controlled trials, 11 pilot studies, and over 1000 co-design sessions using MOST. Additionally, published qualitative findings from diverse clinical contexts and a review of related digital mental health literature were included. The study culminated in an updated ToC framework informed by expert feedback. The final ToC was produced in both narrative and table form and captured components common in program logic and ToC frameworks., Results: The MOST ToC captured several assumptions about digital mental health adoption, including factors such as the readiness of young people and service providers to embrace digital platforms. External considerations included high service demand and a potential lack of infrastructure to support integration. Young people and service providers face several challenges and pain points MOST seeks to address, such as limited accessibility, high demand, poor engagement, and a lack of personalized support. Self-determination theory, transdiagnostic psychological treatment approaches, and evidence-based implementation theories and their associated mechanisms are drawn upon to frame the intervention components that make up the platform. Platform usage data are captured and linked to short-, medium-, and long-term intended outcomes, such as reductions in mental health symptoms, improvements in functioning and quality of life, reductions in hospital visits, and reduced overall mental health care costs., Conclusions: The MOST ToC serves as a strategic framework for refining MOST over time. The creation of the ToC helped guide the development of therapeutic content personalization, user engagement enhancement, and clinician adoption through specialized implementation frameworks. While powerful, the ToC approach has its limitations, such as a lack of standardized methodology and the amount of resourcing required for its development. Nonetheless, it provides an invaluable roadmap for iterative development, evaluation, and scaling of MOST and offers a replicable model for other digital health interventions aiming for targeted, evidence-based impact., (©Shane Cross, Jennifer Nicholas, Shaminka Mangelsdorf, Lee Valentine, Simon Baker, Patrick McGorry, John Gleeson, Mario Alvarez-Jimenez. Originally published in JMIR Formative Research (https://formative.jmir.org), 03.11.2023.)

Introduction: Dementia is highly prevalent in older Aboriginal Australians, with several modifiable risk factors. Currently, there is limited evidence on how to prevent cognitive decline in Aboriginal Australians., Methods: Based on our Theory of Change (ToC) framework, we co-developed the Dementia risk management and prevention program for Aboriginal Australians (DAMPAA) aged over 45 years in partnership with Aboriginal community-controlled organizations (ACCOs) and Elders. Qualitative data were collected through ACCO staff workshops, Elders yarning, and governance groups to inform the protocol. Additionally, we conducted a small pilot study., Results: Expected DAMPAA ToC outcomes are: (1) improved daily function, (2) better cardiovascular risk management, (3) falls reduction, (4) improved quality of life, and (5) reduced cognitive decline. Attendance enablers are social interaction, environment, exercise type/level, and logistics., Discussion: Findings suggest that ToC is an effective collaborative approach for co-designing Aboriginal health programs., (© 2023 The Authors. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association.)

Objective: Multicomponent interventions are recommendable to achieve the greatest mental health benefits, but are difficult to evaluate due to their complexity. Defining long-term outcomes, arising from a Theory of Change (ToC) and testing them in a pilot phase, is a useful approach to plan a comprehensive and meaningful evaluation later on. This article reports on the pilot results of an outcome evaluation of a complex mental health intervention and examines whether appropriate evaluation measures and indicators have been selected ahead of a clustered randomised control trial (cRCT)., Methods: The MENTUPP pilot is an evidence-based intervention for Small and Medium Enterprises (SMEs) active in three work sectors and nine countries. Based on our ToC, we selected the MENTUPP long-term outcomes, which are reported in this article, are measured with seven validated scales assessing mental wellbeing, burnout, depression, anxiety, stigma towards depression and anxiety, absenteeism and presenteeism. The pilot MENTUPP intervention assessment took place at baseline and at 6 months follow-up., Results: In total, 25 SMEs were recruited in the MENTUPP pilot and 346 participants completed the validated scales at baseline and 96 at follow-up. Three long-term outcomes significantly improved at follow-up (p < 0.05): mental wellbeing, symptoms of anxiety, and personal stigmatising attitudes towards depression and anxiety., Conclusions: The results of this outcome evaluation suggest that MENTUPP has the potential to strengthen employees' wellbeing and decrease anxiety symptoms and stigmatising attitudes. Additionally, this study demonstrates the utility of conducting pilot workplace interventions to assess whether appropriate measures and indicators have been selected. Based on the results, the intervention and the evaluation strategy have been optimised., (© 2023. The Author(s).)

The purpose of this article is to share a Canadian model called Developing a Compassionate Community (DCC) in which aging, dying, caregiving, and grieving are everyone's responsibility. The model provides a research-informed practice guide for people who choose to adopt a community capacity development approach to developing a compassioante community. Based on 30 years of Canadian research by the author in rural, urban, First Nations communities, and long-term care homes, the DCC model offers a practice theory and practical tool. The model incorporates the principles of community capacity development which are as follows: change is incremental and in phases, but nonlinear and dynamic; the change process takes time; development is essentially about developing people; development builds on existing resources (assets); development cannot be imposed from the outside; and development is ongoing (never-ending). Community capacity development starts with citizens who want to make positive changes in their lives and their community. They become empowered by gaining the knowledge, skills, and resources they need. The community mobilizes around finding solutions rather than discussing problems. Passion propels their action and commitment drives the process. The strategy for change is engaging, empowering, and educating community members to act on their own behalf. It requires mobilizing networks of families, friends, and neighbors across the community, wherever people live, work, or play. Community networks are encouraged to prepare for later life, and for giving and getting help among themselves. This Canadian model offers communities one approach to developing a compassionate community and is a resource for implementing a public health approach to end-of-life care in Canada. The model is also available to be evaluated for its applicability beyond Canada and is designed to be adapted to new contexts if desired., Competing Interests: The author declares that there is no conflict of interest., (© The Author(s), 2023.)

Background: Paramedics are increasingly being called to attend patients dying from advanced incurable conditions. However, confidence to deal with such calls varies, with many feeling relatively unskilled in this aspect of their role. A number of interventions have been piloted to improve their skills in end-of-life care (EoLC) but without a fully specified theoretical model. Theory of Change models can provide theoretical and testable links from intervention activities to proposed long-term outcomes and indicate the areas for assessment of effectiveness. This study aimed to develop an intervention for improving paramedic EoLC for patients in the community., Methods: A Theory of Change approach was used as the overarching theoretical framework for developing an intervention to improve paramedic end-of-life skills. Nine stakeholders - including specialist community paramedics, ambulance call handlers and palliative care specialists - were recruited to five consecutive online workshops, ranging between 60 and 90 min. Each workshop had 2-3 facilitators. Over multiple workshops, stakeholders decided on the desired impact, short- and long-term outcomes, and possible interventions. During and between these workshops a Theory of Change model was created, with the components shared with stakeholders., Results: The stakeholders agreed the desired impact was to provide consistent, holistic, patient-centred, and effective EoLC. Four potential long-term outcomes were suggested: (1) increased use of anticipatory and regular end-of-life medications; (2) reduced end-of-life clinical and medication errors; (3) reduced unnecessary hospitalisations; (4) increased concordance between patient preferred and actual place of death. Key interventions focused on providing immediate information on what to do in such situations including: appraising the situation, developing an algorithm for a treatment plan (including whether or not to convey to hospital) and how to identify ongoing support in the community., Conclusions: A Theory of Change approach was effective at identifying impact, outcomes, and the important features of an end-of-life intervention for paramedics. This study identified the need for paramedics to have immediate access to information and resources to support EoLC, which the workshop stakeholders are now seeking to develop as an intervention., (© 2023. The Author(s).)

Hospital-based violence intervention programs (HVIP) are critical to interrupting the cycle of violence. These interventions are considered "complex" in that they have many mechanisms of change and related outcomes. Few HVIPs clearly identify the underlying mechanisms of intervention and explicitly link those with key outcomes however, limiting the field's ability to know what works best and for whom. To develop a program theory of change for these "complex interventions," a non-linear, robust methodology that is grounded in the lived experience of those delivering and receiving services is needed. To aid researchers, evaluators, students, and program developers, we describe the use of Grounded Theory as a methodology to enhance the development of complex interventions, illuminating a non-linear approach that engages key stakeholders. To illustrate application, we describe a case example of The Antifragility Initiative, a HVIP in Cleveland, Ohio. The development of the program theory of change was conducted in four phases: (1) review of existing program documents, (2) semi-structured interviews with program developers (n = 6), (3) a focus group with program stakeholders (n = 8), and (4) interviews with caregivers and youth (n = 8). Each phase informed the next and culminated in a theoretical narrative and visual model of the Antifragility Initiative. Together, the theoretical narrative and visual model identify the underlying mechanisms that can promote change by the program., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Knowledge of what conservation interventions improve biodiversity outcomes, and in which circumstances, is imperative. Experimental and quasi-experimental methods are increasingly used to establish causal inference and build the evidence base on the effectiveness of interventions, but their ability to provide insight into how and under what conditions an intervention should be implemented to improve biodiversity outcomes faces limitations. A suite of attribution methods that leverage qualitative methods for causal inference is available but underutilized in conversation impact evaluation. This article provides a guide to 5 such qualitative attribution methods: contribution analysis, process tracing, realist evaluation, qualitative comparative analysis, and most significant change. It defines and introduces each method and then illustrates how they could be applied through a case study of community conservancies in Namibia. This guide provides examples of how qualitative attribution methods can advance knowledge of what works, in which contexts, and why in biodiversity conservation., (© 2023 The Authors. Conservation Biology published by Wiley Periodicals LLC on behalf of Society for Conservation Biology.)

The United States Department of Agriculture's Gus Schumacher Nutrition Incentive Program (GusNIP) supports nutrition incentive (NI) and produce prescription programs (PPRs). PPRs allow healthcare providers to "prescribe" fruits and vegetables (FVs) to patients experiencing low income and/or chronic disease(s) and who screen positive for food insecurity. We developed a Theory of Change (TOC) that summarizes how and why PPRs work, identifies what the programs hope to achieve, and elucidates the causal pathways necessary to achieve their goals. We created the PPR TOC through an iterative, participatory process that adapted our previously developed GusNIP NI TOC. The participatory process involved food and nutrition security experts, healthcare providers, PPR implementors, and PPR evaluators reviewing the existing NI TOC and suggesting modifications to accurately reflect PPRs. The resulting TOC describes the mechanisms, assumptions, rationale, and underpinnings that lead to successful and equitable outcomes. Modifications of the NI TOC centered around equity and focused on inclusion of healthcare as an additional partner and the importance of health and healthcare utilization as outcomes. The TOC describes how the GusNIP PPR program reaches its goals. This understanding will be useful for PPR developers, implementers, funders, and evaluators for describing the pathways, assumptions, and foundations of successful PPRs.

Introduction: Given the progressive aging of the population, there is an urgent need at the health system level to implement effective models to care for older people (OP). Healthy aging is imperative to reach the Sustainable Development Goals. The World Health Organization (WHO) developed the Integrated Care for Older People (ICOPE) strategy to address this challenge. Implementing ICOPE requires its adaption to a specific context. We propose a pathway for such adaptation through an evaluation of the design of ICOPE; thus, we aim to describe the Theory of Change (ToC) of ICOPE and evaluate it for its implementation in Mexico City., Methods: Based on the WHO and published literature documentation, we drafted an initial ToC for ICOPE. Then, we validated the ToC with experts in ICOPE, after which we evaluated and refined it by discussing the causal pathway, intervention required to activate it, rationale, and assumptions in consecutive workshops with 91 stakeholders and healthcare workers, using the nominal group technique to reach a consensus., Results: The resulting ToC has the potential to contribute to healthy aging by three expected impacts: (1) prevention, reversal, or delaying of the decline of intrinsic capacity (IC) in OP; (2) improvement of the quality of life of OP; and (3) increase of disability-free life expectancy. The ICOPE causal pathway had ten preconditions, including the availability of resources, identifying at-risk individuals, available treatments, and evaluating results., Discussion: We adapted ICOPE to a specific implementation context by evaluating its ToC in a participatory process that allows us to identify challenges and address them, at least in terms of the guidelines to operate the strategy. As ICOPE is an approach for a primary healthcare system, its adoption in a community healthcare program is promising and feasible. Evaluation as a tool could contribute to the design of effective interventions. The evaluation of the design of ICOPE for its implementation contributes to the strength of its potential to improve care for OP. This design for implementing ICOPE has the potential to be applied to similar contexts, for example, in other lower-middle-income countries., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Gutiérrez-Barreto, Sosa-Tinoco, Rojas-Calixto, Deniss-Navarro, Avila-Avila and Gutierrez.)

Issues Addressed: Several national governments are showing interest in policies to promote wellbeing. One common strategy is to devise systems to measure indictors of wellbeing, presuming that governments act on what they measure. This article will argue instead that formation of multisectoral policies to promote psychological wellbeing requires a different kind of theoretical and evidentiary basis., Methods: The article integrates ideas from literature on wellbeing, health in all policies, political science, mental health promotion, and social determinants of health to make a case for place-based policy as the central feature of multi-sectoral policy for psychological wellbeing., Results and Discussion: I argue that the required theoretical foundation for policy action on psychological wellbeing lies with understanding certain basic functions of human social psychology including the role of stress arousal. I then draw on policy theory to propose three steps to translate this theoretical understanding of psychological wellbeing into practicable, multi-sectoral policies. Step one is concerned with adopting a thoroughly revised conception of psychological wellbeing as a policy problem. Step two involves uptake of a theory of change in policy, grounded on recognition of essential social conditions required to promote psychological wellbeing. Proceeding from these, I will argue that a necessary (but not sufficient) third step is to implement place-based strategies involving government-community partnerships, to generate essential conditions for psychological wellbeing on a universal basis. Finally, I examine implications of the proposed approach for current theory and practice in mental health promotion policy., Conclusions: Place-based policy is foundational for effective multi-sectoral policy to promote psychological wellbeing. SO WHAT?: Governments aiming to promote psychological wellbeing should position place-based policy at the centre of their strategies., (© 2023 The Author. Health Promotion Journal of Australia published by John Wiley & Sons Australia, Ltd on behalf of Australian Health Promotion Association.)

Purpose: To create a set of criteria to assess facilitators and barriers to implementation among gender transformative interventions that target very young adolescents (VYAs) across different cultural settings., Methods: Interventionists and researchers involved in the Global Early Adolescent Study created a Theory of Change (ToC) based on summarizing intervention components from five different gender transformative intervention curricula. Embedded within the ToC is a set of criteria labeled, 'Conditions of Success' which were developed to illustrate that change cannot happen unless interventions are implemented successfully. To test the feasibility of these criteria, implementation data collected across the five interventions in Global Early Adolescent Study were mapped onto the 'Conditions for Success' criteria and used to identify common facilitators and barriers to implementation., Results: Using the 'Conditions for Success' criteria, we found that gender transformative interventions targeting VYAs were most challenged in meeting program delivery and facilitation conditions and needed to build more multisectoral support to shift rigid gender norms. Parents and caregivers also needed to be engaged in the program either as a separate target population or as codesigners and implementers for the interventions., Discussion: The Conditions for Success criteria provide a useful framework for assessing facilitators and barriers to implementation among gender transformative interventions for VYAs. Additional research is underway to examine whether interventions that meet more conditions of success result in greater program impact, which will be used to further refine the overall ToC., (Copyright © 2022. Published by Elsevier Inc.)

Background: The implementation of new and complex interventions in mental health settings can be challenging. This paper explores the use of a Theory of Change (ToC) for intervention design and evaluation to increase the likelihood of complex interventions being effective, sustainable, and scalable. Our intervention was developed to enhance the quality of psychological interventions delivered by telephone in primary care mental health services., Methods: A ToC represents how our designed quality improvement intervention targeting changes at service, practitioner, and patient levels was expected to improve engagement in, and the quality of, telephone-delivered psychological therapies. The intervention was evaluated following implementation in a feasibility study within three NHS Talking Therapies services through a qualitative research design incorporating semi-structured interviews and a focus group with key stakeholders (patients, practitioners, and service leads) (N = 15). Data were analysed using the Consolidated Framework for Implementation Research (CFIR) and the ToC was examined and modified accordingly following the findings., Results: CFIR analysis highlighted a set of challenges encountered during the implementation of our service quality improvement telephone intervention that appeared to have weakened the contribution to the change mechanisms set out by the initial ToC. Findings informed changes to the intervention and refinement of the ToC and are expected to increase the likelihood of successful future implementation in a randomised controlled trial., Conclusions: Four key recommendations that could help to optimise implementation of a complex intervention involving different key stakeholder groups in any setting were identified. These include: 1-developing a good understanding of the intervention and its value among those receiving the intervention; 2-maximising engagement from key stakeholders; 3-ensuring clear planning and communication of implementation goals; and 4-encouraging the use of strategies to monitor implementation progress., (© 2023. The Author(s).)

Background: Adult patients admitted to intensive care units in the terminal phase experience high symptom burden, increased costs, and diminished quality of dying. There is limited literature on palliative care engagement in ICU, especially in lower-middle-income countries. This study explores a strategy to enhance palliative care engagement in ICU through a stakeholder participatory approach., Methods: Theory of Change approach was used to develop a hypothetical causal pathway for palliative care integration into ICUs in India. Four facilitated workshops and fifteen research team meetings were conducted virtually over three months. Thirteen stakeholders were purposively chosen, and three facilitators conducted the workshops. Data included workshop discussion transcripts, online chat box comments, and team meeting minutes. These were collected, analysed and represented as theory of change map., Results: The desired impact of palliative care integration was good death. Potential long-term outcomes identified were fewer deaths in ICUs, discharge against medical advice, and inappropriate admissions; increased referrals to palliative care; and improved patient and family satisfaction. Twelve preconditions were identified, and eleven key interventions were developed. Five overarching assumptions related to contextual factors influencing the outcomes of interventions., Conclusion: Theory of change framework facilitated the identification of proposed mechanisms and interventions underpinning palliative care integration in ICUs., Competing Interests: Declaration of Competing Interest The Authors declare that there is no conflict of interest., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

This paper argues that assumptions in a theory of change are the causal connections, events, and conditions that need to be realized for the intervention to work. Using an example of an intervention aimed at improving educational outcomes for girls in a conservative region, two kinds of assumptions are discussed: cause-effect assumptions and causal-link assumptions. Implications for the use of theories of change, including their use in setting causality and the utility of evidence in argument for learning about and testing assumptions are also discussed. The need for an explicit description of what is meant by the term 'assumptions' in association with a theory of change is also highlighted., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

This paper focuses on the application of evaluation based on a Theory of Change Approach, including elements of Realistic Evaluation to a transport intervention; the UK's first Workplace Parking Levy (WPL) introduced in 2012 in the City of Nottingham. A WPL places a charge off-street parking provided by employers. The scheme acts as a transport demand management measure with the revenue hypothecated for funding transport improvements. The WPL and the measures that it funds thus form an integrated package aimed at achieving social, economic and environmental benefits. The approach afforded a robust evaluation of the outcomes and impacts of a WPL package of measures. Based on this case study it is able to conclude that this evaluation approach is an appropriate framework for evaluating public sector interventions in general and transport interventions specifically and recommend as to how the methodology may be refined for future transport evaluations., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

This paper used a blended approach that involves multiple techniques to, first, test a set of assumptions around a health behavior change communication intervention theory of change (ToC) and, second, surface some unidentified assumptions involving the local context. The intervention was integrated with women's self-help groups (SHGs) in Uttar Pradesh, India. The key assumption tested in this paper was the linkage between SHG membership, program exposure, and maternal, newborn, and child health practices. Learnings were substantiated through empirical investigations, including structural equation modeling and mediation analysis, as well as 'co-learning' workshops within the community. The workshops aimed to capture and interpret the heterogeneity of local contexts through deep dialogs with the community and program implementers at various levels. Statistical analyses indicated a significant association between the amount of women's program exposure and their health practices. SHG membership was shown to affect maternal health practices; however, it did not have a direct effect on neonatal or child health practices. The 'co-learning' workshops revealed crucial aspects, such as prevailing socio-cultural norms, which prevented pregnant or recently delivered women from participating in SHG meetings. This paper encourages evaluators to work with the community to interpret and co-construct meaning in unpacking the contextual forces that seldom appear in the program ToC., Competing Interests: Declaration of interests None., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

There are no effective intervention studies for people using substances who are at, or near, the end of their lives. The needs of this group of people have been consistently overlooked even within the literature that identifies marginalised groups of people in need of greater recognition in palliative and end-of-life care. The aims of the project were to: (i) determine what a new, co-produced, model of care should look like for people using substances needing palliative and end-of-life care, and (ii) establish whether the new model had the potential to improve people's access to, and experience of, end-of-life care. This paper presents the development of the new approach to care. It was developed using participatory action research principles over a course of online workshops during the COVID-19 pandemic lockdown period in the UK. A theory of change that aims to inform future policy and practice development is presented. While the ambition of the research was stunted by the pandemic, the process of its development and dissemination of the model and its resources has continued. Response from participants highlighted the importance of this work, however, in this new field of policy and practice, preparatory work that engages a wide range of stakeholders is crucial to its success. This relationship building and topic engagement are major parts of implementation before more substantial and sustainable development goals can be met.

Background: India has one of the largest adolescent populations in the world. Yet adolescents, particularly adolescent girls, have limited access to correct sexual and reproductive health information and services. The context in which adolescent girls live is one of gender inequity where they contend with early marriage and early pregnancy and have few opportunities for quality education and labor force participation. The digital revolution has expanded the penetration of mobile phones across India, increasingly being used by adolescent girls. Health interventions are also moving onto digital platforms. Evidence has shown that applications of game elements and game-based learning can be powerful tools in behavior change and health interventions. This provides a unique opportunity, particularly for the private sector, to reach and empower adolescent girls directly with information, products, and services in a private and fun manner., Objective: The objective of this paper is to describe how a design-led Theory of Change (ToC) was formulated for a mobile game app that is not only underpinned by theories of various behavior change models but also identifies variables and triggers for in-game behavioral intentions that can be tracked and measured within the game and validated through a rigorous post-gameplay outcome evaluation., Methods: We describe the use of a multimix methodology to formulate a ToC informing behavioral frameworks and co-design approaches in our proof-of-concept product development journey. This process created a statement of hypothesis and "pathways to impact" with a continuous, cumulative, and iterative design process that included key stakeholders in the production of a smartphone app. With theoretical underpinnings of social behavior and modeling frameworks, systematic research, and other creative methods, we developed a design-led ToC pathway that can delineate complex and multidisciplinary outputs for measuring impact., Results: The statement of hypothesis that emerged posits that "If girls virtually experience the outcomes of choices that they make for their avatar in the mobile game, then they can make informed decisions that direct the course of their own life." Four learning pathways (DISCOVER, PLAY, DECIDE, and ACT) are scaffolded on 3 pillars of evidence, engagement, and evaluation to support the ToC-led framework. It informs decision-making and life outcomes through game-based objectives and in-game triggers that offer direct access to information, products, and services., Conclusions: This approach of using a multimix methodology for identifying varied and multidisciplinary pathways to change is of particular interest to measuring the impact of innovations, especially digital products, that do not necessarily conform with traditional behavioral change models or standard co-design approaches. We also explain the benefits of using iterative and cumulative inputs to integrate ongoing user feedback, while identifying pathways to various impacts, and not limiting it to only the design and development phase., (©Lalita Shankar, Anvita Dixit, Susan Howard. Originally published in JMIR Formative Research (https://formative.jmir.org), 18.04.2023.)

Background: The objective of this scoping review was to map how child health service interventions develop, utilise, and refine theories of change. A Theory of Change (ToC) is a tool for designing, implementing, and evaluating interventions that is being increasingly used by child health practitioners who are aiming to enact change in health services., Methods: A published protocol guided this scoping review. Relevant publications were identified through selected electronic databases and grey literature via a search strategy. The main inclusion criteria were any child health service intervention globally that described their ToC or ToC development process. These were applied by two independent reviewers. Data relevant to the research sub-questions were extracted, charted and discussed., Findings: 38 studies were included in the analysis. This scoping review highlights the disparate and inconsistent use, and reporting of ToCs in the child health service intervention literature., Conclusion: A ToC may be a helpful tool to enact change in a child health service but careful consideration must be undertaken by the child health service regarding how to maximise the benefits of doing a ToC, and how to accurately report it., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Jones, Paterson, English and Nagraj.)

Introduction: Integrated care is an important strategy for increasing health system performance. Despite its growing significance, detailed evidence on the measurement properties of integrated care instruments remains vague and limited. This article aims to present the Monitoring and Evaluation Framework (M&EF) used in the pilot program of coordinated primary care in Poland. It can serve as an example of Monitoring and Evaluation (M&E) concept for the countries taking their first steps in the care integration implementation or establishing PHC reforms. This article belongs to the series of publications entitled: "Highway to hell or stairway to heaven - evaluating complex integrated care models - lessons from the Primary Healthcare Plus pilot program (PHC Plus) in Poland"., Methods: The M&EF of the PHC Plus was based on the Theory of Change within which a shift was to take place in the following 4 aspects: (1) change in health outcomes among participating patients; (2) change in health care experience among participating patients; (3) change in the fragmentation of care provided for chronic diseases among participating patients; (4) change in overall spending on health services for the patients in the PHC Plus facilities. Data for the M&EF of the PHC Plus came from two main sources: the National Health Fund (national insurer) database and the results survey questionnaires., Results: Based on the established M&EF of PHC Plus it was possible to monitor and evaluate the change in patients' health outcomes, health experience and health literacy, fragmentation of care index, and overall spending on healthcare services offered in the pilot. Some of the analyzes planned could not be carried out due errors in data reporting systems, the lack of data of adequate quality or the pandemic. However, M&E implementation process provided many insightful information supporting broader PHC reform in Poland. Inclusive process of information and data sharing, discussions with the country health stakeholders and solid analytical background allowed for better informed policy making and scaling up the pilot., Conclusion: M&E process was put in place to help identify interventions, processes and approaches that could be scaled up and implemented at the country level. This approach resulted in broader understanding and acceptance of the proposed reforms in the PHC in Poland, following PHC Plus pilot implementation. Tools and approaches available and used to evaluate care integration in the PHC setting may not fully respond to the PHC and care integration system characteristic and country capacity. Therefore, revised M&E approach should be an integral part of the health policy interventions and further development of the PHC. Care integration specific measurement tools should be considered. Integration is a complex, multidimensional concept that requires measurement at multiple levels, including the patient level, the provider (professional) level, organizational and systems level. The M&E system of care integration requires use of multidimensional approach, complexed data systems, but also active sharing process of key findings. A phased approach is recommended to help researchers define clearly where they are in the research process and show progress on the outcomes' achievement. Some simplification of the M&EF used in the PHC Plus is recommended to increase its sustainability without loosing key analytics., Competing Interests: One of the authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Grant for primary healthcare transformation from the Gates Foundation; member of the editorial board of the open access, free publication multisectoral journal Global Health Science and Practice. There are no further competing interests., (Copyright: © 2023 The Author(s).)

To understand the impact of the international Master's programmes offered at the Institute of Development Policy (University of Antwerp), a theory-based evaluation was undertaken. In the first phase, a Theory of Change (ToC) was elaborated, distinguishing between three levels of impact (individual, organisational and societal), four learning dimensions (knowledge, skills, attitudes and networks) and five implicit pathways (change agent, social network, widening access, academic diversity, international understanding). Given the multifaceted and vague nature of the 'impact' concept under study, we selected an international, gender-balanced, multi-sectoral team of alumni researchers who fostered inclusiveness of different perspectives, at the same time capitalising on their depth of understanding, having gone through the study experience themselves. A mixed-methods approach was adopted to validate the ToC, combining a Most Significant Change approach, categorisation and text analysis of 101 alumni impact stories. Our findings demonstrate the importance of the three levels of impact and four learning dimensions in capturing graduate impact. While the impact stories confirmed the dominant 'change agent' pathway, they also hinted at the importance of hybrid complementary configurations of pathways to fully grasp how impact materialises., Competing Interests: Declaration of competing interest None., (Copyright © 2023. Published by Elsevier Ltd.)

Projects and programs have long been the primary instrument for achieving development goals in low- and middle-income countries. One criticism of the project-focused approach is its failure to focus on broader system-level changes. This paper explores how Mayne's COM-B Theory of Change model can enhance the evaluation of how projects and system-level investments can lead to system-level changes, especially in a development context. Using a real-world example, we offer several evaluation questions to initiate thinking about what might be needed to extend the ideas in the COM-B theory of change to facilitate better interrogation of systems-level change efforts., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Understanding the dynamic relationship between service providers and the people who use their services is key to effective evaluation. This paper presents a practical approach to embedded evaluation that can be used by services to interrogate assumptions about relationships. The approach includes a simple framework for developing theories of change that centres relational aspects of the change process. This framework is complemented by a structured approach to surfacing risks and assumptions. Using the example of the evaluation of Future Pathways, a new and ground breaking service provided to people who experienced abuse or neglect as children In Care in Scotland, the paper describes how this approach was used in practice. Focusing in on assumptions identified by the service around trust, the paper describes the process undertaken to interrogate these assumptions through data collection with people using the service and staff. This process led to rich learning to support the development of the service as well as the identification of new elliptical assumptions. The paper concludes by sharing reflections on the learning from this work for the wider evaluation community highlighting the need for evaluators to take a relational approach to interrogating assumptions about relationships., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

This paper highlights how learnings from exploring assumptions can be strengthened by taking an evolutionary approach to theory building and analysis. We discuss theory-driven evaluation applied to a community-based intervention implemented by Dancing With Parkinson's in Toronto, Canada, targeting Parkinson's disease (PD), a neurodegenerative condition affecting movement. A major gap in the literature is understanding the mechanisms by which dance might make a difference in the daily lives of people living with PD. This study was an early exploratory evaluation to better understand mechanisms and short-term outcomes. Conventional thinking generally favors "permanent" over "transitory" changes, and "long-term" over "short-term" effects. Yet, for people living with degenerative conditions (and also people experiencing chronic pain and other chronic symptoms), transitory and short-term changes may be highly valued and welcomed relief. In order to study and link multiple longitudinal events to explore key linkages in the theory of change, we piloted the use of diaries, with brief entries filled out daily by participants. The aim was to better understand the short-term experiences of participants using their daily routines as a means of learning about potential mechanisms, what matters to participants, and to see if small effects could be observed on days when participants danced versus days when they did not dance and also longitudinally over several months. Our initial theoretical stance began with a view of dance as exercise and the well-established benefits of exercise; yet, we explored through the diary data collected, as well as client interviews and literature review, potential other mechanisms of dancing (such as group interaction, touch, stimulation by the music, and esthetics including "feeling lovely"). This paper does not develop a full, comprehensive theory of dance but moves towards a more comprehensive view that locates dance within the routine activities of participants' daily lives. We argue that given the challenges of evaluating complex interventions comprising multiple, interacting components, there is a need for an evolutionary learning process to understand heterogeneities in mechanisms -- what works for whom -- when faced with knowledge incompleteness in the theory of change., Competing Interests: Declarations of interest None., (Copyright © 2023. Published by Elsevier Ltd.)

The papers in this volume grapple with various issues related to the use of theories of change in program evaluation. This introductory paper reviews some of the critical challenges that arise in developing and learning from theory-driven evaluations. These challenges include the relationship between theories of change and ecologies of evidence, the need for epistemic fluency in learning, and coming to terms with the initial incompleteness of knowledge in program mechanisms. The nine papers that follow, which represent a geographically diverse set of evaluations and evaluators (including Scotland, India, Canada, USA), help develop these and other themes. This volume of papers also serves as a celebration of the work of John Mayne, one of the foremost theory-driven evaluators of the last few decades. John passed away in December of 2020. This volume is intended to honor his legacy while also identifying challenging issues that call for further development., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

While the testing of known assumptions in a theory of change is important, so too is the discovery or surfacing of previously unrecognized assumptions. This paper describes and illustrates the surfacing of "elliptical assumptions," which involve the unknown ingredients that are necessary for a program to be effective. Identifying the ingredients of program success is important for several reasons, which include (a) guiding the development of an improved theory of change, which in turn can guide program improvement, and (b) informing efforts to transfer the program to other settings and populations. However, when an observed pattern, such as differential program effects, points to the existence of a previously unidentified but important ingredient, this might be a just-so story, a seemingly compelling but inaccurate account. Accordingly, the testing of previously unidentified elliptical assumptions is recommended and illustrated., Competing Interests: Declarations of Competing interest None., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

This paper is a reflection on how evaluators could approach theories of change through a foresight lens. It explores the role of assumptions and especially anticipatory assumptions in how we design our theories of change. It argues for a more open approach, a transdisciplinary approach to the multiple knowledges we bring to bear. It goes on to argue that if we do not build and use our imaginations to think differently about the future than the past, as evaluators we risk being trapped in findings and recommendations that assume continuity in a highly discontinuous world., (Copyright © 2023. Published by Elsevier Ltd.)