BACKGROUND: Returning to work after long-term sick leave can be challenging, particularly in small- and medium-sized enterprises (SMEs) where support may be limited. Recognizing the responsibilities and challenges of SME employers, a web-based intervention (hereafter the SME tool) has been developed. The SME tool aims to enhance the employer\'s intention and ability to support the sick-listed employee. Based on the Self-Determination Theory, it is hypothesized that this intention is enhanced by intervening in the employer\'s autonomy, competences, and relatedness targeted at, e.g., communication with sick-listed employee, involvement of other stakeholders, and practical support. This is achieved by means of providing templates, communication videos, and information on legislation. This article describes the design of an effect and process evaluation of the SME tool.
METHODS: A randomized controlled trial (RCT) with a 6-month follow-up will be conducted with a parallel-group design with two arms: an intervention group and a control group. Sick-listed employees (≤ 8 weeks) of SMEs (≤ 250 employees) at risk of long-term sick leave and their employers will be recruited and randomly allocated as a dyad (1:1). Employers randomized to the intervention group receive unlimited access to the SME tool, while those in the control group will receive care as usual. The primary outcome is the satisfaction of the employee with the return to work (RTW) support provided by their employer. Secondary outcomes include social support, work performance, and quality of work life at the employee level and self-efficacy in providing RTW support at the employer level. Outcomes will be assessed using questionnaires at baseline and 1, 3, and 6 months of follow-up. Process evaluation measures include, e.g., recruitment and use of and perceived usefulness of the SME tool. Additionally, semi-structured interviews with employers, employees, and occupational physicians will explore the interpretation of the RCT results and strategies for the national implementation of the SME tool.
CONCLUSIONS: The SME tool is hypothesized to be valuable in addition to usual care helping employers to effectively support the RTW of their long-term sick-listed employees, by improving the employers\' intention and ability to support.
BACKGROUND: ClinicalTrials.gov, NCT06330415. Registered on February 14, 2024.

BACKGROUND: Comprehensive sexuality education (CSE) is critical in addressing negative sexual and reproductive health (SRH) outcomes among adolescents. Yet in many low- and middle-income countries (LMICs) including Zambia, little is known about the impact, realities of CSE implementation, the quality of teaching and the comprehensiveness of the content covered.
METHODS: Our approach was informed by a process evaluation incorporating recommendations by the European Expert Group guidance on evaluating sexuality education programmes and the Medical Research Council (MRC) guidelines on process evaluation. The development process and quality of CSE implementation were assessed using eight and six quality criteria respectively. In-depth interviews (IDIs), focus group discussions (FGDs), document analysis and classroom observation were employed to assess contextual factors, implementation process and mechanisms of impact of CSE. In-depth interviews (50) and focus group discussions (2) with seven pupils in each group were conducted among 64 purposefully selected participants. The sample comprised pupils (35), parents (4) and teachers (17) from nine secondary schools (four peri-urban, four urban and one rural), policymakers (4), and religious leaders (4). We employed deductive content analysis to analyse the data.
RESULTS: Contextual factors that influenced the implementation of CSE included: (1) piecemeal funding for the CSE programme; (2) lack of monitoring programmes in schools; (3) lack of community engagement; (4) religious and socio-cultural barriers; (5) lack of skills and competency to teach CSE; and (6) insufficient time allocation for CSE. The assessment of the quality of the development of CSE revealed: (1) a lack of sexual diversity; (2) no meaningful participation of pupils in programme implementation; (3) a lack of stakeholder engagement during programme implementation; (4)  lack of gender sensitivity; and (5) lack of human rights approach. Assessment of the quality of the implementation of CSE revealed: (1) no evidence of skill-based CSE teaching; (2) no linkage between CSE and SRH services in the communities; and (3) a lack of incorporation of multiple delivery methods during CSE teaching. The mechanisms of impact of CSE were related to the acceptability and positive changes in pupils\' SRH practices.
CONCLUSIONS: The complex influences of contextual factors during CSE implementation highlight the need for contextual analysis during the interventional design. Co-creation of the CSE programme through stakeholder participation could reduce social opposition and enable a culturally sensitive CSE. Comprehensive teacher training, a guiding curriculum as well as setting of appropriate monitoring tools and indicators are likely to enhance the quality of CSE implementation.

BACKGROUND: POINCARE-2 trial aimed to assess the effectiveness of a strategy designed to tackle fluid overload through daily weighing and subsequent administration of treatments in critically ill patients. Even in highly standardized care settings, such as intensive care units, effectiveness of such a complex intervention depends on its actual efficacy but also on the extent of its implementation. Using a process evaluation, we aimed to provide understanding of the implementation, context, and mechanisms of change of POINCARE-2 strategy during the trial, to gain insight on its effectiveness and inform the decision regarding the dissemination of the intervention.
METHODS: We conducted a mixed-method process evaluation following the Medical Research Council guideline. Both quantitative data derived from the trial, and qualitative data from semi-structured interviews with professionals were used to explain implementation, mechanisms of change of the POINCARE-2 strategy, as well as contextual factors potentially influencing implementation of the strategy.
RESULTS: Score of actual exposure to the strategy ranged from 29.1 to 68.2% during the control period, and from 61.9 to 92.3% during the intervention period, suggesting both potential contamination and suboptimal fidelity to the strategy. Lack of appropriate weighing devices, lack of human resources dedicated to research, pre-trial rooted prescription habits, and anticipated knowledge of the strategy have been identified as the main barriers to optimal implementation of the strategy in the trial context.
CONCLUSIONS: Both contamination and suboptimal fidelity to POINCARE-2 strategy raised concerns about a potential bias towards the null of intention-to-treat (ITT) analyses. However, optimal fidelity seemed reachable. Consequently, a clinical strategy should not be rejected solely on the basis of the negativity of ITT analyses\' results. Our findings showed that, even in highly standardized care conditions, the implementation of clinical strategies may be hindered by numerous contextual factors, which demonstrates the critical importance of assessing the viability of an intervention, prior to any evaluation of its effectiveness.
BACKGROUND: Number NCT02765009.

BACKGROUND: Stepping Stones Triple P (SSTP) is a complex parent-mediated intervention aimed to reduce behaviours that challenge in children with moderate to severe intellectual disabilities, aged 30-59 months.
METHODS: To formulate a comprehensive understanding of SSTP implementation in the UK, we conducted a process evaluation collecting stakeholder views and considering intervention fidelity, dose, reach, delivery adaptations, and acceptability.
RESULTS: Fidelity and quality of delivery ratings were high. Parents perceived SSTP as valuable, reporting increased parental confidence and understanding of the child\'s behaviours. However, only 30% of families received an adequate dose of the intervention. Parents who only received treatment as usual described feeling abandoned by current services. Service managers emphasised the importance of availability of resources and therapist training for successful intervention delivery.
CONCLUSIONS: SSTP supports effective management of early-onset behaviours that challenge. Further work is needed to ensure equitable access to the intervention across health and social care services.
BACKGROUND: NCT03086876 - https://www.
RESULTS: gov/ct2/show/NCT03086876?term=Hassiotis+Angela&draw=1&rank=1.

BACKGROUND: The Assessment of Burden of Chronic Conditions (ABCC-)tool is developed to facilitate a personalized approach to care in the patient-healthcare provider (HCP) conversation based on shared decision-making and individualized care plans. An effectiveness study highlighted its effect on the perceived quality of care and patient activation. Successful implementation of novel interventions necessitates an understanding of the user\'s actual application, user experiences and an evaluation of implementation outcomes. This study aims to evaluate the implementation of the ABCC-tool by HCPs in Dutch primary care.
METHODS: This study is the process evaluation of a larger type 1 effectiveness-implementation hybrid trial. Semi-structured interviews with HCPs, who were interventionists in the hybrid trial, were held at three and twelve months after they started using the ABCC-tool. The Reach-Effectiveness-Adoption-Implementation-Maintenance (RE-AIM) framework was used to evaluate implementation outcomes. The Implementation domain was further strengthened with an evaluation of implementation fidelity using Carroll\'s framework. Inductive coding and thematic analysis were applied to identify relevant participant experiences and implementation outcomes within the RE-AIM framework.
RESULTS: Seventeen HCPs (1 general practitioner, 16 practice nurses) participated in the study, representing 39% of potentially eligible participants. Most HCPs applied the tool after finishing their own routines instead of how it is intended to be used, namely from the beginning of the consultation. HCPs reached 2-6 patients. The ABCC-tool was initially adopted, but twelve HCPs stopped using the tool due to COVID-19 related cancellation of consultations. High fidelity was found for applying the questionnaire and visualization. Low fidelity was present for applying shared decision-making, formulating care goals and monitoring progress. HCPs indicated that maintaning the ABCC-tool depended on accompanying training and implementation support.
CONCLUSIONS: HCPs applied the ABCC-tool critically different from intended, potentially diminishing its benefits and ease of use. This evaluation stresses the need for a tailored implementation plan that includes more detailed training and guidance on how and when to use the ABCC-tool.

BACKGROUND: Co-creation is seen as a way to ensure all relevant needs and perspectives are included and to increase its potential for beneficial effects and uptake process evaluation is crucial. However, existing process evaluation frameworks have been built on practices characterised by top-down developed and implemented interventions and may be limited in capturing essential elements of co-creation. This study aims to provide a review of studies planning and/or conducting a process evaluation of public health interventions adopting a co-creation approach and aims to derive assessed process evaluation components, used frameworks and insights into formative and/or participatory evaluation.
METHODS: We searched for studies on Scopus and the Health CASCADE Co-Creation Database. Co-authors performed a concept-mapping exercise to create a set of overarching dimensions for clustering the identified process evaluation components.
RESULTS: 54 studies were included. Conceptualisation of process evaluation included in studies concerned intervention implementation, outcome evaluation, mechanisms of impact, context and the co-creation process. 22 studies (40%) referenced ten existing process evaluation or evaluation frameworks and most referenced were the frameworks developed by Moore et al (14%), Saunders et al (5%), Steckler and Linnan (5%) and Nielsen and Randall (5%).38 process evaluation components were identified, with a focus on participation (48%), context (40%), the experience of co-creators (29%), impact (29%), satisfaction (25%) and fidelity (24%).13 studies (24%) conducted formative evaluation, 37 (68%) conducted summative evaluation and 2 studies (3%) conducted participatory evaluation.
CONCLUSIONS: The broad spectrum of process evaluation components addressed in co-creation studies, covering both the evaluation of the co-creation process and the intervention implementation, highlights the need for a process evaluation tailored to co-creation studies. This work provides an overview of process evaluation components, clustered in dimensions and reflections which researchers and practitioners can use to plan a process evaluation of a co-creation process and intervention.

BACKGROUND: Combination prevention interventions, when integrated with community-based support, have been shown to be particularly beneficial to adolescent and young peoples\' sexual and reproductive health. Between 2020 and 2022, the Africa Health Research Institute in rural South Africa conducted a 2 × 2 randomised factorial trial among young people aged 16-29 years old (Isisekelo Sempilo) to evaluate whether integrated HIV and sexual and reproductive health (HIV/SRH) with or without peer support will optimise delivery of HIV prevention and care. Using mixed methods, we conducted a process evaluation to provide insights to and describe the implementation of a community-based peer-led HIV care and prevention intervention targeting adolescents and young people.
METHODS: The process evaluation was conducted in accordance with the Medical Research Council guidelines using quantitative and qualitative approaches. Self-completed surveys and clinic and programmatic data were used to quantify the uptake of each component of the intervention and to understand intervention fidelity and reach. In-depth individual interviews were used to understand intervention experiences. Baseline sociodemographic factors were summarised for each trial arm, and proportions of participants who accepted and actively engaged in various components of the intervention as well as those who successfully linked to care were calculated. Qualitative data were thematically analysed.
RESULTS: The intervention was feasible and acceptable to young people and intervention implementing teams. In particular, the STI testing and SRH components of the intervention were popular. The main challenges with the peer support implementation were due to fidelity, mainly because of the COVID-19 pandemic. The study found that it was important to incorporate familial support into interventions for young people\'s sexual health. Moreover, it was found that psychological and social support was an essential component to combination HIV prevention packages for young people.
CONCLUSIONS: The results demonstrated that peer-led community-based care that integrates SRH services with HIV is a versatile model to decentralise health and social care. The family could be a platform to target restrictive gender and sexual norms, by challenging not only attitudes and behaviours related to gender among young people but also the gendered structures that surround them.

OBJECTIVE: This study aims to enhance the analysis of healthcare processes by introducing Object-Centric Process Mining (OCPM). By offering a holistic perspective that accounts for the interactions among various objects, OCPM transcends the constraints of conventional patient-centric process mining approaches, ensuring a more detailed and inclusive understanding of healthcare dynamics.
METHODS: We develop a novel method to transform the Observational Medical Outcomes Partnership Common Data Models (OMOP CDM) into Object-Centric Event Logs (OCELs). First, an OMOP CDM4PM is created from the standard OMOP CDM, focusing on data relevant to generating OCEL and addressing healthcare data\'s heterogeneity and standardization challenges. Second, this subset is transformed into OCEL based on specified healthcare criteria, including identifying various object types, clinical activities, and their relationships. The methodology is tested on the MIMIC-IV database to evaluate its effectiveness and utility.
RESULTS: Our proposed method effectively produces OCELs when applied to the MIMIC-IV dataset, allowing for the implementation of OCPM in the healthcare industry. We rigorously evaluate the comprehensiveness and level of abstraction to validate our approach\'s effectiveness. Additionally, we create diverse object-centric process models intricately designed to navigate the complexities inherent in healthcare processes.
CONCLUSIONS: Our approach introduces a novel perspective by integrating multiple viewpoints simultaneously. To the best of our knowledge, this is the inaugural application of OCPM within the healthcare sector, marking a significant advancement in the field.

BACKGROUND: Providing supported self-management for people with asthma can reduce the burden on patients, health services and wider society. Implementation, however, remains poor in routine clinical practice. IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) is a UK-wide cluster randomised implementation trial that aims to test the impact of a whole-systems implementation strategy, embedding supported asthma self-management in primary care compared with usual care. To maximise opportunities for sustainable implementation beyond the trial, it is necessary to understand how and why the IMP2ART trial achieved its clinical and implementation outcomes.
METHODS: A mixed-methods process evaluation nested within the IMP2ART trial will be undertaken to understand how supported self-management was implemented (or not) by primary care practices, to aid interpretation of trial findings and to inform scaling up and sustainability. Data and analysis strategies have been informed by mid-range and programme-level theory. Quantitative data will be collected across all practices to describe practice context, IMP2ART delivery (including fidelity and adaption) and practice response. Case studies undertaken in three to six sites, supplemented by additional interviews with practice staff and stakeholders, will be undertaken to gain an in-depth understanding of the interaction of practice context, delivery, and response. Synthesis, informed by theory, will combine analyses of both qualitative and quantitative data. Finally, implications for the scale up of asthma self-management implementation strategies to other practices in the UK will be explored through workshops with stakeholders.
CONCLUSIONS: This mixed-methods, theoretically informed, process evaluation seeks to provide insights into the delivery and response to a whole-systems approach to the implementation of supported self-management in asthma care in primary care. It is underway at a time of significant change in primary care in the UK. The methods have, therefore, been developed to be adaptable to this changing context and to capture the impact of these changes on the delivery and response to research and implementation processes.

This process evaluation was conducted in parallel to the randomised controlled feasibility trial of NIDUS-Professional, a manualised remote dementia training intervention for homecare workers (HCWs), delivered alongside an individualised intervention for clients living with dementia and their family carers (NIDUS-Family). The process evaluation reports on: (i) intervention reach, dose and fidelity; (ii) contexts influencing agency engagement and (iii) alignment of findings with theoretical assumptions about how the intervention might produce change.
We report proportions of eligible HCWs receiving any intervention (reach), number of sessions attended (dose; attending ≥4/6 main sessions was predefined as adhering), intervention fidelity and adherence of clients and carers to NIDUS-Family (attending all 6-8 planned sessions). We interviewed HCWs, managers, family carers and facilitators. We integrated and thematically analysed, at the homecare agency level, qualitative interview and intervention recording data.
32/141 (23%) of eligible HCWs and 7/42 (17%) of family carers received any intervention; most who did adhered to the intervention (89% and 71%). Intervention fidelity was high. We analysed interviews with 20/44 HCWs, 3/4 managers and 3/7 family carers, as well as intervention recordings involving 32/44 HCWs. All agencies reported structural challenges in supporting intervention delivery. Agencies with greater management buy-in had higher dose and reach. HCWs valued NIDUS-Professional for enabling group reflection and peer support, providing practical, actionable care strategies and increasing their confidence as practitioners.
NIDUS-Professional was valued by HCWs. Agency management, culture and priorities were key barriers to implementation; we discuss how to address these in a future trial.