Evaluation Of Complex Interventions Research Articles

Development and validation of the physical exercise program “Active Mums” for postpartum recovery: application of the CReDECI-2 guidelines

Postpartum physical activity is a public health issue. Reporting on the quality of exercise interventions designs must be ensured in view of the reproducibility and successful implementation of such studies. The objective was to develop and preliminary validate a physical exercise program for postpartum recovery, aiming to promote physical fitness and health of the new mothers. The study was carried out through the three stages of development, piloting, and evaluation. The Consensus on Exercise Reporting Template (CERT) was used to describe the postpartum exercise program. The Criteria for Reporting the Development and Evaluation of Complex Interventions in Healthcare (CReDECI2) was followed to develop and preliminary validate the program. A tailored postpartum exercise program was developed based on evidence-based international recommendations to be implemented by qualified exercise professionals. A pilot intervention of 16 weeks was carried out, engaging a group of postpartum women. The viability of the program was subsequently evaluated by all participants. The present work provided guidance to develop a study protocol with a larger sample in order to prove the effectiveness of a supervised postpartum exercise program on selected parameters of health.

Protocol for process evaluation of ARTEMIS cluster randomised controlled trial: an intervention for management of depression and suicide among adolescents living in slums in India

IntroductionThere are around 250 million adolescents (10–19 years) in India. The prevalence of mental health-related morbidity among adolescents in India is approximately 7.3%. Vulnerable subpopulations among adolescents such as those...

Process evaluation of a Structured E-parenting Support (STEPS) in the OPTIMA randomised controlled trial: a protocol.

Structured E-parenting Support (STEPS) is a digital application (app) designed to help parents manage behaviour of their children who are referred to mental health services and are waiting for an assessment or treatment. STEPS is currently being evaluated in the Online Parent Training for the Initial Management of Attention-Deficit/Hyperactivity Disorder randomised controlled trial. Alongside the examination of STEPS' clinical and cost-effectiveness, we are conducting a process evaluation to better understand the contextual factors that may influence study outcomes. The purpose of this protocol is to describe the aims, objectives and methodology of the process evaluation prior to it taking place to add to the fidelity and rigour of the trial process and outcomes. Our goal is to adapt STEPS to optimise its benefits in future applications. In line with the Medical Research Council guidelines for evaluating complex interventions, the process evaluation will adopt a mixed method design using qualitative data collected from clinicians and parent interviews and app usage data from participants assigned to the intervention arm. Qualitative data from semistructured interviews and free text box responses included in trial questionnaires will be analysed thematically using framework analysis to better understand how parents use STEPS, how it works and key factors that could aid or hinder its effective implementation in routine clinical practice. The application for ethical approval for the study was submitted to the North West-Liverpool Central Research Ethics Committee and received a favourable opinion on further information on 26 November 2021, reference number 21/NW/0319. The process evaluation aims to explore how a digital app might support parents in managing their child's behaviour. Implications for policy and research will be explored and the clinical implications of offering the app to a wider audience to address the lack of support to parents as highlighted in this paper. We plan to publish findings in international, peer-reviewed journals as well as present at conferences. The trial has been prospectively registered on 18 November 2021; ISRCTN816523503. https://www.isrctn.com/ISRCTN16523503.

Development of a program theory for osteoporosis patient education in Denmark: a qualitative study based on realist evaluation

BackgroundOsteoporosis patient education is offered in many countries worldwide. When evaluating complex interventions like these, it is important to understand how and why the intervention leads to effects. This study aimed to develop a program theory of osteoporosis patient education in Danish municipalities with a focus on examining the mechanisms of change i.e. what is about the programs that generate change.MethodsThe program theory was developed in an iterative process. The initial draft was based on a previous published systematic review, and subsequently the draft was continually refined based on findings from observations (10 h during osteoporosis patient education) and interviews (individual interviews with six employees in municipalities and three health professionals at hospitals, as well as four focus group interviews with participants in patient education (in total 27 informants)). The transcribed interviews were analyzed using thematic analysis and with inspiration from realist evaluation the mechanisms as well as the contextual factors and outcomes were examined.ResultsBased on this qualitative study we developed a program theory of osteoporosis patient education and identified four mechanisms: motivation, recognizability, reassurance, and peer reflection. For each mechanism we examined how contextual factors activated the mechanism as well as which outcomes were achieved. For instance, the participants’ motivation is activated when they meet in groups, and thereafter outcomes such as more physical activity may be achieved. Recognizability is activated by the participants’ course of disease, which may lead to better ergonomic habits. Reassurance may result in more physical activity, and this mechanism is activated in newly diagnosed participants without previous fractures. Peer reflection is activated when the participants meet in groups, and the outcome healthier diet may be achieved.ConclusionsWe developed a program theory and examined how and why osteoporosis patient education is likely to be effective. Understanding these prerequisites is important for future implementation and evaluation of osteoporosis patient education.

Towards more robust evaluation of policies and programmes in education: identifying challenges in evaluating DEIS and Reading Recovery

ABSTRACT In recent years, countries including the UK and USA have seen advancements in the use of Randomised Controlled Trials in education, progress that has not been mirrored in Ireland. Ireland does not have a strong tradition of using experimental or quasi-experimental evaluation designs for monitoring and evaluation of education policy despite well-articulated commitments to the latter activities. An example is the evaluation of the Delivering Equality of Opportunity in Schools (DEIS) programme where little is known about the causal impact of DEIS on student outcomes, despite considerable State investment over almost 20 years. There appears to have been comparatively little critical review of the literacy and numeracy programmes offered to DEIS schools, with those included at the outset largely still on offer. Here, we draw on the wider literature on the evaluation of complex interventions and consider what lessons may be learned for Ireland, illustrating challenges and opportunities by focusing on DEIS and Reading Recovery (a literacy support programme widely used in DEIS schools). We advocate for greater use of experimental designs where feasible and appropriate; further gathering of comparable measures of achievement at pupil level to facilitate monitoring; and detailed consideration of quasi-experimental methods that can support causal conclusions.

Study protocol for a systems evaluation of an infant mental health service: Integration of 'Little Minds Matter' into the early years system.

Infant Mental Health relates to how well a child develops socially and emotionally from birth to age three. There is a well-established link between parent-infant relationship quality, Infant Mental Health, and longer-term social and emotional development there is a lack of evidence-based interventions that support the parent-infant relationship and/or protect against poor Infant Mental Health. Little Minds Matter is a specialist Infant Mental Health service developed in Bradford (UK) to support parent-infant relationships by providing training and consultation for professionals and direct clinical work to families. The successful implementation of this intervention depends upon how well it becomes embedded within, or integrated into, the early years system. For the purposes of this study, the early years system includes health, social and education services that support child health and development from conception to primary school entry at age five. This study protocol aims to apply a systems approach to evaluate this service and provide a perspective on the process of embedding a complex service within a healthcare system. Multiple methods will be used to investigate embeddedness within the wider early years system. Routinely collected quantitative data about the service will be used to develop a system map showing interaction with related services. Qualitative data will be collected at two time points through interviews with individuals involved in the design and provision of the service, and professionals working within the early years system. Framework analysis will be used to analyse the data inductively and deductively within a systems approach. The findings from this study will provide evidence to inform the ongoing implementation of the service for providers and commissioning bodies. Exploring the application of a systems approach in this clinical context will have application more broadly for researchers evaluating complex interventions and services within a wider system.

The development of a novel sexual health promotion intervention for young people with mental ill-health: the PROSPEct project

BackgroundYoung people with mental ill-health experience higher rates of high-risk sexual behaviour, have poorer sexual health outcomes, and lower satisfaction with their sexual wellbeing compared to their peers. Ensuring good sexual health in this cohort is a public health concern, but best practice intervention in the area remains under-researched. This study aimed to co-design a novel intervention to address the sexual health needs of young people with mental ill-health to test its effectiveness in a future trial undertaken in youth mental health services in Melbourne, Australia.MethodsWe followed the 2022 Medical Research Council (MRC) guidelines for developing and evaluating complex interventions. This involved synthesising evidence from the ‘top down’ (published evidence) and ‘bottom up’ (stakeholder views). We combined systematic review findings with data elicited from qualitative interviews and focus groups with young people, carers, and clinicians and identified critical cultural issues to inform the development of our intervention.ResultsExisting evidence in the field of sexual health in youth mental health was limited but suggested the need to address sexual wellbeing as a concept broader than an absence of negative health outcomes. The Information-Motivation-Belief (IMB) model was chosen as the theoretical Framework on which to base the intervention. Interviews/focus groups were conducted with 29 stakeholders (18 clinicians, three carers, and eight young people). Synthesis of the evidence gathered resulted in the co-design of a novel intervention consisting of an initial consultation and four 60-90-minute sessions delivered individually by a young ‘sex-positive’ clinician with additional training in sexual health. Barriers and supports to intervention success were also identified.ConclusionsUsing the MRC Framework has guided the co-design of a potentially promising intervention that addresses the sexual health needs of young people with mental ill-health. The next step is to test the intervention in a one-arm feasibility trial.

A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance

The UK Medical Research Council’s widely used guidance for developing and evaluating complex interventions has been replaced by a new framework, commissioned jointly by the Medical Research Council and the National Institute for Health Research, which takes account of recent developments in theory and methods and the need to maximise the efficiency, use, and impact of research.

Study protocol for the Screen-Free Time with Friends Feasibility Trial

BackgroundChildren are spending less leisure time with their friends in person and an increasing amount of time with digital screens. These changes may negatively affect children’s physical and mental health. The Screen-Free Time with Friends Feasibility Trial will test the feasibility, including acceptability and compliance, of an intervention designed to reduce screen media usage and encourage physical interaction with friends during leisure time in 9–11-year-old children.MethodsA non-randomized single-group feasibility trial will be conducted from March to October 2023 including approximately 75 children (aged 9–11 years) and 75 parents (at least 1 per child) from 3 different schools recruited from 3 different municipalities in Denmark. The Screen-Free Time with Friends intervention is a multicomponent intervention targeting families, afterschool clubs, and local communities. It has been developed using a systematic process guided by the Medical Research Council UK’s framework for developing and evaluating complex interventions. With a systems perspective in mind, the intervention and implementation approach has been designed to facilitate adaptation to the specific needs of diverse local communities while maintaining the core components of the intervention.Feasibility and acceptability of the intervention will be assessed during the intervention using process evaluation inspired by the RE-AIM framework including questionnaires and interviews with the municipality project managers, research team members, local ambassadors and stakeholders, parents and school, and afterschool club personnel. In addition, participation, recruitment, retention rate, and compliance to the outcome measurements will be investigated and presented.DiscussionThe trial will investigate the feasibility and acceptability of the Screen-Free Time with Friends intervention, the recruitment strategy, and the planned outcome measurements. This feasibility study will investigate necessary refinements before the implementation of the intervention program in a larger cluster randomized controlled trial to evaluate its impact.Trial registration.ClinicalTrials.gov, ID: NCT05480085. Registered 29 July 2022. https://clinicaltrials.gov/ct2/show/NCT05480085?cond=Screen+free+time+with+friends&draw=2&rank=1

Brain-IT: Targeting the brain using information technology for secondary prevention of mild neurocognitive disorder

Brain-IT: Targeting the brain using information technology for secondary prevention of mild neurocognitive disorder

Development of a Multimodal, Physiotherapist-Led, Vocational Intervention for People with Inflammatory Arthritis and Reduced Work Ability: A Mixed-Methods Design Study.

Work ability of people with rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA) is reduced, but underexamined as a clinical treatment target. The evidence on vocational interventions indicates that delivery by a single healthcare professional (HCP) may be beneficial. Physiotherapist (PT)-led interventions have potential because PTs are most commonly consulted by RA/axSpA patients in the Netherlands. The aim was to develop a PT-led, vocational intervention for people with RA/axSpA and reduced work ability. Mixed-methods design based on the Medical Research Council (MRC) framework for developing and evaluating complex interventions, combining a rapid literature review and six group meetings with: patient representatives (n = 6 and 10), PTs (n = 12), (occupational) HCPs (n = 9), researchers (n = 6) and a feasibility test in patients (n = 4) and PTs (n = 4). An intervention was developed and evaluated. Patient representatives emphasized the importance of PTs' expertise in rheumatic diseases and work ability. The potential for PTs to support patients was confirmed by PTs and HCPs. The feasibility test confirmed adequate feasibility and underlined necessity of training PTs in delivery. The final intervention comprised work-focussed modalities integrated into conventional PT treatment (10-21 sessions over 12 months), including a personalized work-roadmap to guide patients to other professionals, exercise therapy, patient education and optional modalities. A mixed-methods design with stakeholder involvement produced a PT-led, vocational intervention for people with RA/axSpA and reduced work ability, tested for feasibility and ready for effectiveness evaluation.

Process evaluation of school-based high-intensity interval training interventions for children and adolescents: a systematic review and meta-analysis of randomized controlled trials

BackgroundSeveral systematic reviews have been published to investigate the effectiveness of high-intensity interval training (HIIT) in schools. However, there has been limited attention given to understanding the functioning of the intervention processes, which is of paramount importance for interpreting and translating the intervention effectiveness. The aim of this systematic review is to determine the extent to which process evaluation is measured in school-based HIIT interventions and to explore the effects of process evaluation and intervention characteristics on cardiorespiratory fitness (CRF), body composition, muscular strength, and blood pressure.MethodsA comprehensive search was conducted in SPORT Discus (EBSCOhost), Web of Science, Scopus, Medline (Ovid) and Cochrane Central Register of Controlled Trials. The extent to which process evaluation is measured was narratively reported, alongside with the guidance of process evaluation of complex interventions by UK Medical Research Council. Meta-analyses and meta-regressions were conducted to determine the effects of process evaluation and intervention characteristics to the intervention outcomes.ResultsThe literature search identified 77 studies reporting on 45 school-based HIIT interventions. In total, five interventions reported process evaluation in a section or in a separate study, and only one intervention adopted a process evaluation framework. On average, 6 out of 12 process evaluation measures were reported in all interventions. Subgroup analyses did not indicate any beneficial treatment effects for studies with process evaluation group, whereas all pooled data and studies without process evaluation group showed significant improvement for CRF and body composition.ConclusionProcess evaluation is frequently omitted in the literature of school-based HIIT in children and adolescents. Although reporting of process evaluation measures may not directly associate with better intervention outcomes, it allows accurate interpretation of intervention outcomes, thereby enhancing the generalisability and dissemination of the interventions.

Co-design of the EMBED-Care Framework as an intervention to enhance shared decision-making for people affected by dementia and practitioners, comprising holistic assessment, linked with clinical decision support tools: A qualitative study.

Shared decision-making intends to align care provision with individuals' preferences. However, the involvement of people living with dementia in decision-making about their care varies. We aimed to co-design the EMBED-Care Framework, to enhance shared decision-making between people affected by dementia and practitioners. A theory and evidence driven co-design study was conducted, using iterative workshops, informed by a theoretical model of shared decision-making and the EMBED-Care Framework (the intervention) for person-centred holistic palliative dementia care. The intervention incorporates a holistic outcome measure for assessment and review, linked with clinical decision-support tools to support shared decision-making. We drew on the Medical Research Council (MRC) guidance for developing and evaluating complex interventions. Participants included people with dementia of any type, current or bereaved family carers and practitioners. We recruited via established dementia groups and research and clinical networks. Data were analysed using reflexive thematic analysis to explore how and when the intervention could enhance communication and shared decision-making, and the requirements for use, presented as a logic model. Five co-design workshops were undertaken with participants comprising people affected by dementia (n = 18) and practitioners (n = 36). Three themes were generated, comprising: (1) 'knowing the person and personalisation of care', involving the person with dementia and/or family carer identifying the needs of the person using a holistic assessment. (2) 'engaging and considering the perspectives of all involved in decision-making' required listening to the person and the family to understand their priorities, and to manage multiple preferences. (3) 'Training and support activities' to use the Framework through use of animated videos to convey information, such as to understand the outcome measure used to assess symptoms. The intervention developed sought to enhance shared decision-making with individuals affected by dementia and practitioners, through increased shared knowledge of individual priorities and choices for care and treatment. The workshops generated understanding to manage disagreements in determining priorities. Practitioners require face-to-face training on the intervention, and on communication to manage sensitive conversations about symptoms, care and treatment with individuals and their family. The findings informed the construction of a logic model to illustrate how the intervention is intended to work.

Examining the implementation of a community paediatric clinic in a socially disadvantaged Irish community: A retrospective process evaluation.

Understanding interventions and their implementation is essential for improving community initiatives. Kidscope is a community paediatric development clinic providing free health and developmental assessment and onward referral for children aged zero to six years in an urban area of southern Ireland where many children experience complex needs. Established in 2010, Kidscope developed an inter-disciplinary, multi-agency community team by drawing on the strengths of local services and practitioners to deliver holistic approaches to child health and development. Recent studies examining stakeholder engagement and Kidscope outcomes highlighted the need to examine implementation to better understand the processes and mechanisms of the clinic and how events have affected outcomes. Guided by the UK Medical Research Council Framework for Developing and Evaluating Complex Interventions, this study used a post-hoc qualitative process evaluation study design with multiple data sources; stakeholder perspectives (interviews, focus group, questionnaires) and document analysis (annual reports, meeting minutes, work plans). A diverse set of research questions were developed in conjunction with a Patient and Public Involvement Group. Guiding frameworks supported thematic analysis of primary data, document analysis of secondary data, and triangulation of findings across datasets. Data analysis yielded 17 themes and 18 sub-themes. Successful implementation hinged on developing a coalition of linked practitioners and services whose skills were utilised and enhanced within Kidscope to deliver a high-quality healthcare model to vulnerable children and families. Relational and multi-disciplinary working, innovative approaches to implementation and sustainability, training and education provision, and the accessible community location were among the mechanisms of change resulting in improved child, family, practitioner, and system-level outcomes. External factors such as COVID-19 and deficits in Ireland's disability services posed significant barriers to fidelity. This study provides evidence of the processes, mechanisms, and model of care employed by a community-based paediatric clinic to successfully engage society's most vulnerable families and promote health equity. This study makes an important contribution to the field of implementation research by offering an example of a robust approach to conceptualising and measuring implementation outcomes of community healthcare initiative in a changing, real-world context.

The complex intervention day hospice — a quality-assured study on the implementation, realization, and benefits with model character for Germany (IMPULS) using the example of “Day hospice Adiuvantes”

BackgroundCurrently, a conclusive experience on the uniform implementation and benefits of day hospice structures and interventions is lacking in Germany. The following questions should be clarified: (1) Which structural conditions and interventional measures should be established in day hospices from the point of view of patients, relatives, and specialist staff?; (2) Are the planned structures or interventions feasible and implementable under real conditions and accepted by patients, relatives, and staff?; (3) How can a final implementation and intervention catalog for day hospices be designed?; (4) Is this final catalog of services feasible, reasonable, economical, and effective under everyday conditions in day hospices?MethodsWe planned to perform a multistage investigation, guided by the Medical Research Council Framework for the development and evaluation of complex interventions. In Stage 1, an initial theoretical construct on structures and interventions will be established through an extensive literature and guideline review on day hospices and through qualitative interviews. In a nominal group process, we will create a catalog of offers. In Stage 2, feasibility testing is conducted in a single-day hospice under real-life conditions using quantitative quality indicators and qualitative interviews. Structures and interventions can be adapted here if necessary. In a second nominal group process, a final structure and offer catalog is created, which is then implemented in Stage 3 in the day hospice under investigation and evaluated under real daily conditions through a process and effectiveness test. For this purpose, qualitative and quantitative quality indicators will be used and a comparative cohort of patients who are not cared for in the day hospice – but in the same network structure (oncology–palliative care network Lower Bavaria) – is examined.DiscussionFinally, the initial statements on the reasonable and realizable structures or interventions in day hospices and their benefits in daily real-life conditions as well as possible optimization processes shall be made.Trial registrationThe study was retrospectively registered in the German Clinical Trials Register (DRKS-ID DRKS00031613, registration date April 04, 2023) and the display portal of the Center for Clinical Trials of the University Hospital Regensburg (Z-2022-1734-6, registration date July 01, 2023).

Co-production of a rehabilitation programme for young adult cancer survivors

Introduction: Globally, the focus on user involvement in health research has increased substantially. In Denmark, it is still at an early stage, with individual researchers being met with increasing demands without having much experience, guidance, or good practices to act upon. We are a group of researchers affiliated with User Perspectives and Community-based Interventions at the University of Southern Denmark and the Center for Research with Patients and Relatives (ForSa-P) at the Odense University Hospital. We work with patients and relatives in several aspects of our work – research and teaching; we share our experiences and learning in a joint session.
 This presentation describes a co-creation process of developing a rehabilitation programme for young adult cancer survivors (YACS)
 Background: Because of the cancer and late effects of treatment, YACS face numerous age-specific physical, psychological, existential, and social issues impacting participation in everyday life and decreasing their health-related quality of life (HRQoL). Rehabilitation may improve participation in life roles, leisure activities and work and thus, heighten HRQoL. However, YACS rehabilitation needs are not being adequately met and multicomponent age-specific rehabilitation for YACS is limited.
 Objective: To develop an evidence-based, age-specific, multicomponent, and peer-based rehabilitation programme involving YACS and relevant stakeholders aiming to improve YACS participation in everyday life and their HRQoL.
 Methods: The development process of the programme drawn on the Medical Research Council UK framework for developing and evaluating complex interventions and is inspired by Hawkins et al.’s three-staged framework for co-production. From September 2019 to March 2023, YACS, professionals and researchers co-developed a rehabilitation programme through three stages: 1) Evidence review and stakeholder consultations; 2) Co-production of the intervention by involving users in four workshops, and 3) Articulating the programme theory, developing an intervention manual, recruitment strategy and referral pathways and selecting outcome measures. Key findings from each stage were incorporated into the subsequently stage.
 Results: We developed a comprehensive goal-oriented and peer-based rehabilitation programme called the Young Adults Taking ACtion (YATAC). The programme draws on a person-centered approach, the Social Cognitive Theory, and John Dewey’s learning theory. It consists of nine components delivered by an interdisciplinary team: 1) Need assessment, 2) Goal setting, 3) Everyday life, 4) Physical activity, 5) Psychological issues, 6) Work and education, 7) Sexuality and relationship, 8) Rights and finance, 9) Friends and Family and 10) Peer-to-peer support. Further, outcome measures for the programme were chosen, recruitment strategies were described, and referral pathways were identified. The evaluation showed advantages and disadvantages and future points to pay attention to when participating in a co-production process. 
 Conclusions: A multicomponent rehabilitation programme for YACS was developed involving the preferences and needs of YACS and stakeholders. Using co-production in the whole process of developing the programme will most likely lead to better evaluation and implementation in clinical practice. In addition, the comprehensive description of the development process and the knowledge derived from the process can inform future research of how to involve users in the development of rehabilitation interventions. Next step will be to feasibility test the programme.

A hospital care coordination team intervention for patients with multimorbidity

Objective: To develop and evaluate a hospital care coordination team intervention for patients with multimorbidity and multiple specialists at the outpatient clinic
 Study setting: A middle-large teaching hospital (542 beds) in the Netherlands
 Study design: Practice-based, participatory pilot study with mixed-methods, using the Framework for Developing and Evaluating Complex Interventions. The intervention consisted of an intake, a comprehensive review by a dedicated care coordination team, a consultation to discuss results and two follow-up appointments.
 Data Collection: We included adult patients who had visited seven or more outpatient specialist clinics in 2018. We excluded patients with less than two scheduled hospital appointments or if the potential participant was already receiving coordinated care. We collected quantitative and qualitative data on patient characteristics, number and type of recommendations from the comprehensive review, experiences and short-term outcomes.
 Principal Findings: 250 patients were assessed for eligibility. We excluded 119 patients, 54 of these patients (21,6%) were deceased at the time of assessment and 28 patients (11,2%) had less than two scheduled appointments. Out of 131 invited patients, 28 participants underwent the intake and comprehensive review. The review produced recommendations for at least two out of three categories (medication, involved medical specialists, other) for 21 participants. Patients’ experienced effects of the intervention ranged from very large to no effect. Identified key uncertainties of the intervention were finding the best suited patient population and the minimum of required data that can be collected with feasible effort during regular clinical care.
 Conclusions: The developed hospital care coordination team intervention resulted in mixed outputs and short-term outcomes. We learned that recruitment and selection should be refined to include patients with multimorbidity who might benefit most. Outcomes of research and clinical care should align as much as possible and focus on evaluating the result of care coordination first.

Process evaluation of a primary care-based type 2 diabetes remission project in the North East of England.

A type 2 diabetes remission project, Remission in Diabetes (REMI.D), funded by Sport England, was developed by stakeholders based in the North East of England and begun in early 2020. This local delivery pilot sought to tackle health inequalities by working with multiple organisations to demonstrate a way of scaling up an effective type 2 diabetes remission strategy which included both physical activity and dietary components. The intended delivery of the original project was impacted by the COVID-19 pandemic and changes were made to the project delivery in 2022. The aim of this process evaluation was to learn from the reactive decisions taken by stakeholders which altered the REMI.D project in response to the COVID-19 pandemic. Twelve stakeholders (from local authorities, secondary care, universities, NHS England commissioning, Diabetes UK, Sport England, Everyone Active and Active Partnerships) involved in the design and delivery of the intervention took part in a semi-structured interview lasting up to 60 min. Interviews were recorded and transcribed verbatim. Thematic analysis used the pre-determined 'core content' themes from the Medical Research Council and National Institute for Health Research framework for developing and evaluating complex interventions. Three topics for discussion emerged as follows: (a) lack of effective collaboration, (b) perception of change and (c) scalability of the intervention. Hierarchy within the stakeholder group initially hampered collaboration. Change was reactive as a result of the COVID-19 pandemic. Project changes reduced project sustainability and scalability but offered valuable learning about the need for explicit project theory for partnership working, co-production with service users and project flexibility for long-term health behaviour change.

Applying the framework for developing and evaluating complex interventions to increase family communication about hereditary cancer.

Evaluate an intervention to increase family communication (FC) of positive hereditary cancer test results using the Framework for Developing and Evaluating Complex Interventions (FDECI). We developed 'programme theory' during the FDECI development phase by aligning intervention components with behavior change techniques (BCTs) and theoretical factors expected to improve FC. During the feasibility phase, we obtained feedback from 12 stakeholder interviews. Intervention components aligned with a total of 14 unique BCTs for which prior evidence links the BCT to theoretical factors that influence behavior change. Constructive stakeholder feedback included: more information desired, rewording to support autonomy by highlighting options, and improvements to navigation, visuals, and audio. Positive comments included: comprehensiveness of materials, modeling of conversations, and usefulness of the materials for helping a person prepare to share positive test results. The first FDECI phases were helpful for improving the intervention and planning our ongoing effectiveness and future implementation phases. Our application of the FDECI is novel, including plans to test our 'programme theory' using coincidence analysis (CNA) to determine who accesses which intervention materials, how utilizing certain materials impact the aligned theoretical factors, and whether these in turn make a difference in the behavioral outcome.

Psychosis Recovery Orientation in Malawi by Improving Services and Engagement (PROMISE) protocol.

Malawi has a population of around 20 million people and is one of the world's most economically deprived nations. Severe mental illness (largely comprising psychoses and severe mood disorders) is managed by a very small number of staff in four tertiary facilities, aided by clinical officers and nurses in general hospitals and clinics. Given these constraints, psychosis is largely undetected and untreated, with a median duration of untreated psychosis (DUP) of around six years. Our aim is to work with people with lived experience (PWLE), caregivers, local communities and health leaders to develop acceptable and sustainable psychosis detection and management systems to increase psychosis awareness, reduce DUP, and to improve the health and lives of people with psychosis in Malawi. We will use the UK Medical Research Council guidance for developing and evaluating complex interventions, including qualitative work to explore diverse perspectives around psychosis detection, management, and outcomes, augmented by co-design with PWLE, and underpinned by a Theory of Change. Planned deliverables include a readily usable management blueprint encompassing education and community supports, with an integrated care pathway that includes Primary Health Centre clinics and District Mental Health Teams. PWLE and caregivers will be closely involved throughout to ensure that the interventions are shaped by the communities concerned. The effect of the interventions will be assessed with a quasi-experimental sequential implementation in three regions, in terms of DUP reduction, symptom remission, functional recovery and PWLE / caregiver impact, with quality of life as the primary outcome. As the study team is focused on long-term impact, we recognise the importance of having embedded, robust evaluation of the programme as a whole. We will therefore evaluate implementation processes and outcomes, and cost-effectiveness, to demonstrate the value of this approach to the Ministry of Health, and to encourage longer-term adoption across Malawi.