Rapid qualitative analysis of recruitment obstacles in the FORVAD (Posterior Cervical Foraminotomy surgery versus Anterior Cervical Discectomy surgery in the treatment of cervical brachialgia) randomised, controlled trial.

BACKGROUND: The number of surgical trials is increasing but such trials can be complex to deliver and pose specific challenges. A multi-centre, Phase III, RCT comparing Posterior Cervical Foraminotomy versus Anterior Cervical Discectomy and Fusion in the Treatment of Cervical Brachialgia (FORVAD Trial) was unable to recruit to target. A rapid qualitative study was conducted during trial closedown to understand the experiences of healthcare professionals who participated in the FORVAD Trial, with the aim of informing future research in this area. METHODS: Semi-structured interviews were conducted with 18 healthcare professionals who had participated in the FORVAD Trial. Interviews explored participants' experiences of the FORVAD trial. A rapid qualitative analysis was conducted, informed by Normalisation Process Theory. RESULTS: Four main themes were generated in the data analysis: (1) individual vs. community equipoise; (2) trial set-up and delivery; (3) identifying and approaching patients; and (4) timing of randomisation. The objectives of the FORVAD trial made sense to participants and they supported the idea that there was clinical or collective equipoise regarding the two FORVAD interventions; however, many surgeons had treatment preferences and lacked individual equipoise. The site which had most recruitment success had adopted a more structured process for identification and recruitment of patients, whereas other sites that adopted more "ad hoc" screening strategies struggled to identify patients. Randomisation on the day of surgery caused both medico-legal and practical concerns at some sites. CONCLUSIONS: Organisation and implementation of a surgical trial in neurosurgery is complex and presents many challenges. Sites often reported low recruitment and discussed the logistical issues of conducting a complex surgical RCT. Future trials in neurosurgery may need to offer more flexibility and time during set-up to maximise opportunities for larger recruitment numbers. Rapid qualitative analysis informed by Normalisation Process Theory was able to quickly identify key issues with trial implementation so rapid qualitative analysis may be a useful approach for teams conducting qualitative research in trials. TRIAL REGISTRATION: ISRCTN, ISRCTN reference: 10,133,661. Registered 23rd November 2018.

Implementing workplace health promotion in nursing - A process evaluation in different care settings.

OBJECTIVE: Workplace health promotion (WHP) in Germany is receiving increasing support from health insurance funds. Nevertheless, there is hardly any knowledge on the process of how health outcomes are achieved, especially in nursing. The aim of the study was to find out how and what can be implemented in different care settings and to examine the reactions and interactions of the participants under routine conditions. METHODS: Guided by a logic model, a holistic WHP approach was implemented in four acute care hospitals, seven inpatient care facilities and four outpatient care services from April 2021 to October 2022. Data on realized WHP interventions, participant assessment and topics of work design was collected and analyzed descriptively. RESULTS: The realized WHP interventions were adapted depending on the content and context. Mainly short relaxation interventions were delivered or those with an event character were received by participants. The highest participation rate of planned participants was achieved in team building training. Participants predominantly assessed WHP interventions as useful, the quality as (very) good and were generally (very) satisfied with the intervention components. For work design topics, intentions for the design of work organization were mainly documented in action plans. CONCLUSION: Cooperation with practitioners in research should be continued as a contribution to quality development. This could provide suggestions as to which content adjustments lead to greater acceptance by the target group in a specific context. TRIAL REGISTRATION: The project was registered in the German Clinical Trial Register (DRKS00024961, 2021/04/09).

Enabling AI in Radiology: Evaluation of an AI Deployment Process.

Artificial intelligence (AI) is expected to transform healthcare systems and make them more sustainable. Despite the increased availability of AI tools for disease detection, evidence of their impact on healthcare organisations and patient care remains limited. Drawing on previous research underscoring the need for comprehensive evaluations of real-world AI deployments, this paper explores the challenges and opportunities encountered while procuring and implementing AI solutions for radiology. The paper aims to contribute to a better understanding of the complexities surrounding AI deployments in real-world clinical settings through a process evaluation study.

Process evaluation of a randomised controlled trial intervention designed to improve rehabilitation services for Aboriginal Australians after brain injury: the Healing Right Way Trial.

BACKGROUND: Healing Right Way (HRW) aimed to improve health outcomes for Aboriginal Australians with stroke or traumatic brain injury by facilitating system-level access to culturally secure rehabilitation services. Using a stepped-wedge randomised controlled trial (RCT) design (ACTRN12618000139279, 30/01/2018), a two-pronged intervention was introduced in four rural and four urban hospitals, comprising 1.Cultural security training (CST) for staff and 2.Training/employment of Aboriginal Brain Injury Coordinators (ABIC) to support Aboriginal patients for 6-months post-injury. Three-quarters of recruited patients lived rurally. The main outcome measure was quality-of-life, with secondary outcomes including functional measures, minimum processes of care (MPC); number rehabilitation occasions of service received, and improved hospital experience. Assessments were undertaken at baseline, 12- and 26-weeks post-injury. Only MPCs and hospital experience were found to improve among intervention patients. We report on the process evaluation aiming to support interpretation and translation of results. METHODS: Using mixed methods, the evaluation design was informed by the Consolidated Framework for Implementation Research. Data sources included minutes, project logs, surveys, semi-structured interviews, and observations. Four evaluation questions provided a basis for systematic determination of the quality of the trial. Findings from separate sources were combined to synthesise the emerging themes that addressed the evaluation questions. Three components were considered separately: the trial process, CST and ABIC. RESULTS: The complex HRW trial was implemented to a satisfactory level despite challenging setting factors, particularly rural-urban system dynamics. Patient recruitment constraints could not be overcome. The vulnerability of stepped-wedge designs to time effects influenced recruitment and trial results, due to COVID. Despite relatively high follow-up, including to rural/remote areas, data points were reduced. The lack of culturally appropriate assessment tools influenced the quality/completeness of assessment data. The ABIC role was deemed feasible and well-received. The CST involved complex logistics, but rated highly although online components were often incomplete. Project management was responsive to staff, patients and setting factors. CONCLUSIONS: Despite mostly equivocal results, the ABIC role was feasible within mainstream hospitals and the CST was highly valued. Learnings will help build robust state-wide models of culturally secure rehabilitation for Aboriginal people after brain injury, including MPC, workforce, training and follow-up.

Process evaluation of an mHealth-based school education program to reduce salt intake scaling up in China (EduSaltS): a mixed methods study using the RE-AIM framework.

BACKGROUND: An mHealth-based school health education platform (EduSaltS) was promoted in real-world China to reduce salt intake among children and their families. This progress evaluation explores its implementation process and influencing factors using mixed methods. METHODS: The mixed-methods process evaluation employed the RE-AIM framework. Quantitative data were collected from a management website monitoring 54,435 third-grade students across two cities. Questionnaire surveys (n = 27,542) assessed pre- and post-education effectiveness. Mixed-effects models were used to control cluster effects. Qualitative interviews (23 individuals and 8 focus groups) identified program performance, facilitators, and barriers. Findings were triangulated using the RE-AIM framework. RESULTS: The program achieved 100% participation among all the third-grade classes of the 208 invited primary schools, with a 97.7% registration rate among all the 54,435 families, indicating high "Reach." Qualitative interviews revealed positive engagement from children and parents through the "small hands leading big hands" strategy. The high completion rate of 84.9% for each health cloud lesson and the significant improvement in salt reduction knowledge and behaviors scores from 75.0 (95%CI: 74.7-75.3) to 80.9 (95%CI: 80.6-81.2) out of 100 demonstrated the "Effect" of EduSaltS. The program's "Adoption" and "Implementation" were supported by attractive materials, reduced workload via auto-delivered lessons/activities and performance evaluation, and high fidelity to recommended activities, with medians 3.0 (IQR: 2.0-8.0)/class and 9.0 (IQR: 5.0-14.0)/school. Stable course completion rates (79.4%-93.4%) over one year indicated promising "Maintenance." Apart from the facilitating features praised by the interviewees, government support was the basis for the scaling up of EduSaltS. Barriers included the lack of smartphone skills among some parents and competing priorities for schools. Unhealthy off-campus environments, such as excessive use of salt in pre-packaged and restaurant foods, also hindered salt reduction efforts. The program's scalability was evident through its integration into existing health education, engagement of local governments and adaptation across various mobile devices. CONCLUSIONS: The mHealth-based school health education program is scalable and effective for public salt reduction in China. Identified barriers and facilitators can inform future health program scale-ups. The program's successful implementation demonstrates its potential for broader application in public health initiatives aimed at reducing dietary salt intake.

Using formative process evaluation to improve program implementation and accessibility of competitive group-based physical activity in the TEAM-PA trial.

BACKGROUND: This study demonstrates how formative process evaluation was used to assess implementation and improve dose and fidelity in the Together Everyone Achieves More Physical Activity (TEAM-PA) randomized controlled trial. TEAM-PA uses a randomized group cohort design to evaluate the efficacy of a group-based intervention for increasing physical activity among African American women. METHODS: Intervention groups met for 10 weeks and were co-led by female African American facilitators, with intervention sessions consisting of group feedback, a health curriculum, group-based physical activity games, and group-based goal-setting. Drawing from a multi-theoretical framework, the intervention targeted social affiliation using collaborative and competitive group strategies, including essential elements focused on group-based behavioral skills, peer-to-peer positive communication, collectivism, optimal challenge, social facilitation, and peer to peer challenges. Formative process evaluation was used to monitor reach, dose, and fidelity, and implement feedback and solutions. RESULTS: Across two cohorts, four groups (n = 54) were randomized to the TEAM-PA intervention. On average 84.8% of participants attended each week, which exceeded the a priori criteria. Results from the systematic observations indicated that on average 93% of the dose items were completed in each session and adequate levels of fidelity were achieved at both the facilitator and group-levels. Participants were compliant with wearing the FitBits (6.73 ± 0.42 days/week) and most participants successfully contributed to meeting the group-based goals. The use of open-ended items also revealed the need for additional modifications to the group-based PA games, including allowing for individuals to take breaks, incorporating a broader range of exercises, minimizing activities that required bending/reaching down without assistance, and providing facilitators with additional training for implementing the games. Initial evidence suggests that these changes were successful in increasing participants' comprehension of the games from Cohort 1 (M = 1.83, SD = 0.71) to Cohort 2 (M = 3.33, SD = 0.69). CONCLUSION: Findings from this study demonstrated high levels of reach, dose, and fidelity, while also highlighting strategies for implementing competitive group-based PA games that are accessible across physical fitness levels. Formative process evaluation, including open-ended items and collaborative brainstorming, holds tremendous potential for improving future interventions. TRIAL REGISTRATION: This study was registered on Clinicaltrials.gov (# NCT05519696) on August 22, 2022 prior to the enrollment of the first participant on September 12, 2022 ( https://clinicaltrials.gov/study/NCT05519696?term=NCT05519696&rank=1 ).

Protocol for a pilot cluster randomised controlled trial of PRoGRAM-A (preventing gambling-related harm in adolescents): a secondary school-based social network intervention.

BACKGROUND: In the UK, recent evidence of young people and gambling indicates a higher prevalence of gambling in comparison to other addictive behaviours. Engaging in gambling-related behaviour at a young age is associated with short and long-term consequences, including financial, emotional, academic, interpersonal, and physical and mental health detriments; otherwise known as gambling-related harms (GRH). Given the unique vulnerability of this younger group, early interventions aimed at delaying or preventing gambling are critical. PRoGRAM-A (Preventing Gambling-Related Harm in Adolescents) is a school-based, social network intervention to protect young people from future GRH, by delaying or preventing gambling experimentation. METHODS: Pilot cluster RCT with an embedded process evaluation and health economic scoping study. PARTICIPANTS: PRoGRAM-A will be delivered in four schools, with two control schools acting as a comparator. All are secondary schools in Scotland. Baseline surveys were conducted with students in S3 (ages 13-14). Follow-up surveys were conducted with the same cohort, six months post-baseline. INTERVENTION: PRoGRAM-A trainers will deliver a 2-day, out-of-school training workshop to Peer supporters. Peer supporters will be nominated by peers among their school year group (S3, age 13-14). Workshops will provide peer supporters with information on four gambling-related topics: (1) what is gambling? (2) gambling and gaming, (3) gambling marketing, (4) identifying harm and reducing risk. Peer supporters will disseminate the information (message diffusion) they have learned among their friends and family over a 10-week period. After the 2-day workshop, PRoGRAM-A trainers will conduct × 3 in-school follow-up sessions with peer supporters to offer support, encouragement, and advice to Peer Supporters as well as monitor and explore the extent of their message diffusion. PRIMARY OUTCOME: The primary outcome of the pilot cluster RCT (cRCT) will be whether progression to a phase III RCT is justified. DISCUSSION: This will be the first pilot cluster RCT (cRCT) of an intervention to prevent gambling-related harms among young people within the UK. If findings indicate feasibility and acceptability, funding will be sought for a phase III RCT of effectiveness. TRIAL REGISTRATION: Researchregistry8699. Registered 21st February 2023.

Group-based pelvic floor muscle training for pregnant women: A randomized controlled feasibility study.

AIM: This study aims to test the feasibility and acceptability of a group-based pelvic floor muscle training for pregnant women in China and facilitate women's adherence to the pelvic floor muscle training programme. BACKGROUND: Urinary incontinence is a prevalent health problem in women worldwide, especially in pregnant women. Supervised pelvic floor muscle training is recommended as the first-line conservative treatment for urinary incontinence. However, the implementation and effectiveness of pelvic floor muscle training are limited by insufficient human resources and low adherence. Group-based interventions may improve people's adherence to interventions by facilitating peer support. However, it has been investigated in a limited number of maternity studies. DESIGN: Feasibility testing randomized controlled trial, accompanied by a mixed methods process evaluation. METHODS: This study was guided by the Medical Research Council framework for complex interventions and the Behaviour Change Wheel guide to developing interventions. A three-phase, mixed-methods design was used in this study. This study reported the feasibility of the group-based pelvic floor muscle training programme. Semi-structured reviews were conducted following the intervention to explore the acceptability of the programme. RESULTS: The study included 48 pregnant women with a recruitment rate of 52.17%. The adherence rate to the training programme was 66.67%. The intervention was positively valued, in particular the support promoting participants' adherence, but additional changes need to be made to the programme for a future trial. CONCLUSIONS: Group-based pelvic floor muscle training programme provides a possible way of delivering pelvic floor muscle training with limited health professionals in China. The study showed promising results concerning the acceptability and feasibility of the intervention, which were well perceived by both pregnant women and the midwife. IMPLICATIONS FOR PATIENT CARE: Group-based pelvic floor muscle training may have the potential of reducing the prevalence of urinary incontinence in pregnant women with insufficient healthcare professionals. IMPACT: This study assessed the feasibility of delivering group-based pelvic floor muscle training in pregnant women in China. The group-based pelvic floor muscle training is acceptable to both pregnant women and the midwife, but integrating online and face-to-face sessions need to be considered. The findings of this study provided evidence for delivering group-based pelvic floor muscle training to pregnant women in China. REPORTING METHOD: The study has adhered to CONSORT guidelines (Table S1) and TIDier checklist (Table S2). PATIENT AND PUBLIC CONTRIBUTION: The patient and public have been invited as stakeholders during the development of the intervention. They worked with healthcare professionals to co-design the group-based pelvic floor muscle training programme. REGISTRATION: The trial was registered on ClinicalTrials.gov (NCT05242809) under the title 'Development and Feasibility Testing of a Group-based PFMT Programme for Antenatal Women in Nanjing City in China'.

Methodology for evaluation of complex school-based health promotion interventions.

There is a need for careful examination of large volumes of collected (structured and unstructured) information related to school-based evaluation. There is also no published, comprehensive framework/s for evaluating complex interventions in Irish primary schools. The aim of this paper is to outline a methodology for process evaluation of an Irish primary school-based physical activity (PA) and nutrition intervention. Evaluation followed the three themes outlined by the British Medical Research Council: implementation, context, and mechanism of impact that we further divided into six dimensions. Methodological tools included questionnaires, PA logs, reflective journals, write and draw, and semi-structured interviews. We triangulated findings across these multiple tools to assess each dimension. We designed a unique framework to enable comparisons and offer researchers a template for evaluating complex health promotion interventions in primary schools. We present a methodology for evaluating a complex school-based health promotion intervention. The framework we propose integrates process and outcome data. It aims to enhance future result interpretation and facilitate informed comparisons among intervention schools.

The Impact of Implementation Fidelity of a School-Based Multi-Component Smoking Prevention Intervention on Vocational Students' Smoking Behavior: A Cluster-Randomized Controlled Trial.

Preventing young people's cigarette smoking is a major public health priority, and smoking is especially prevalent in vocational schools. Well-enforced comprehensive school tobacco policies accompanied by preventive efforts show potential to reduce smoking, but the implementation process is crucial to achieve the intended effect. We investigate whether and how implementation fidelity of a multi-component smoking prevention intervention impacted student smoking outcomes after 4-5 months among students in Danish vocational education and training (national age range 15-65 years, mean 25.6) and preparatory basic education (national age range 15-25 years, mean 17.6) institutions using questionnaire data from a cluster-RCT. The intervention included a smoke-free school hours policy, educational curriculum, and class competition. We calculated an overall implementation fidelity measure combining staff-reported school-level delivery (fidelity) and student-reported receipt (participation, responsiveness), and used multilevel regression models to analyze associations with smoking outcomes (smoking daily, regularly, and during school hours). We supplemented the analysis with restricted cubic spline regression. Additionally, we stratified the analyses by school types and analyzed associations between implementation fidelity of the separate intervention components and smoking outcomes. High implementation was associated with lower odds of regular smoking (OR: 0.37, 95% CI: 0.18-0.78) and smoking during school hours, but not daily smoking, and these associations varied between the school settings. When analyzed separately, implementation fidelity of the components did not affect the outcomes significantly. Our findings underline the need to support the implementation process of school tobacco policy interventions to ensure the intended effects of reducing students' smoking.

Experiences with implementing advance care planning (ACP-GP) in Belgian general practice in the context of a cluster RCT: a process evaluation using the RE-AIM framework.

BACKGROUND: General practice is often recommended as an ideal setting to initiate advance care planning (ACP), but uptake of ACP in this setting is low. ACP-GP is a complex intervention to facilitate ACP for patients with chronic, life-limiting illness in Belgian general practice. It aims to increase patient ACP engagement and general practitioner (GP) ACP self-efficacy. In a cluster-randomized controlled trial, the intervention was not superior to control in increasing these outcomes. A parallel process evaluation aimed to enhance understanding of how the intervention was implemented, and which factors might have influenced trial results. METHODS: We conducted a mixed-methods process evaluation following the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. Data sources include recruitment and implementation monitoring, questionnaires for patients and GPs, and semi-structured (focus group) interviews with patients and GPs. Questionnaire data were analyzed descriptively. Qualitative data were first analyzed inductively; themes were then assigned deductively to RE-AIM dimensions. RESULTS: Thirty-five GPs and 95 patients were recruited to the trial; GP reach was low. Sixteen GPs and 46 patients provided questionnaire data at 3 months post-baseline; qualitative data were transcribed for 14 GPs and 11 patients. Adoption of intervention components was moderate to good, with the exception of the documentation template for GPs. Interviews revealed varying patient attitudes towards ACP, but patients nonetheless emphasized that conversations made them feel reassured. GPs especially valued a positive framing of ACP. When adopted, the intervention was well-implemented and participant satisfaction was high. However, intention for maintenance was moderate, with GPs raising questions of how to sustainably implement ACP conversations in the future. CONCLUSIONS: Implementing the complex ACP-GP intervention in general practice is feasible, and can be successful. However, the implementation process is challenging and the sustainability is suboptimal. Our findings will guide future research and recommendations for facilitating and implementing ACP in general practice. TRIAL REGISTRATION: ISRCTN12995230; prospectively registered on 19/06/2020.

Optimizing short-term in-class process evaluation: analyzing the effectiveness of teaching interventions in pharmaceutical education using repeated measures analysis.

BACKGROUND: The assessment of the effectiveness of teaching interventions in enhancing students' understanding of the Pharmaceutical Care Network Europe (PCNE) Classification System is crucial in pharmaceutical education. This is especially true in regions like China, where the integration of the PCNE system into undergraduate teaching is limited, despite its recognized benefits in addressing drug-related problems in clinical pharmacy practice. Therefore, this study aimed to evaluate the effectiveness of teaching interventions in improving students' understanding of the PCNE Classification System in pharmaceutical education. METHODS: Undergraduate pharmacy students participated in a series of sessions focused on the PCNE system, including lectures (t1), case analyses (t2), and practical implementation (t3). The levels of understanding were evaluated using time-course questionnaires. Initially, paired samples t-Tests were used to compare understanding levels between different time points. Subsequently, Repeated Measures Analysis (RMA) was employed. Pearson correlation analysis was conducted to examine the relationship between understanding levels and the usability and likelihood of using the PCNE system, as reported in the questionnaires. RESULTS: The paired samples t-Tests indicated insignificant differences between t2 and t3, suggesting limited improvement following the practical implementation of the PCNE system. However, RMA revealed significant time effects on understanding levels in effective respondents and the focused subgroup without prior experience (random intercept models: all p < 0.001; random slope models: all p < 0.001). These results confirmed the effectiveness of all three teaching interventions. Pearson correlation analysis demonstrated significant positive correlations between understanding levels and the usability and likelihood of using the PCNE system at all examined time points. This finding highlighted the reliability of the understanding levels reported in the questionnaires. The homework scores were used as external calibration standards, providing robust external validation of the questionnaire's validity. CONCLUSION: The implementation of RMA provided robust evidence of the positive impact of time on understanding levels. This affirmed the effectiveness of all teaching interventions in enhancing students' comprehension of the PCNE Classification System. By utilizing RMA, potential errors inherent in common statistical methods, such as t-Tests, were mitigated. This ensured a more comprehensive and accurate assessment of the effectiveness of the teaching interventions.

Implementing the Effective Coach2Move Approach for Community-Dwelling Older Adults with Mobility Limitations in Physical Therapist Practice: A Multi-Methods Process Evaluation.

OBJECTIVE: The aims of this study were to evaluate the adoption of and fidelity to the Coach2Move approach; identify differences between physical therapists with a specialization in geriatrics and physical therapists without a specialization; explore if level of adoption and specialization explain variances in effectiveness; and explore group differences in attitudes and experiences with implementation. METHODS: A multi-methods process evaluation of Coach2Move implementation through 2 education days, 3 peer-assessment meetings, and an adapted electronic health record was performed alongside a cluster randomized stepped-wedge trial comparing regular care physical therapy with Coach2Move. Participants were 36 physical therapists with a specialization (n = 17) and without a specialization (n = 19) who treated 292 community-dwelling older adults. Level of adoption and fidelity were analyzed by comparing pre-implementation scores with scores 1 year later. Coach2Move adoption was measured by e-assessment scores and fidelity through health record indicators. The impact of specialization and adoption on health outcomes was examined using a mixed-model ANOVA. Therapists' attitudes and experiences were collected through a survey based on semi-structured interviews. RESULTS: Mean total indicator scores on the e-assessment (adoption of a Coach2Move mindset) increased from baseline 17% (SD = 5%) to 47% (SD = 9%) at follow-up. Physical therapists with a specialization in geriatrics scored higher than physical therapists without (54% [SD = 6%] vs 41% [SD = 6%]). Mean indicator scores on health records (fidelity) increased from 35% (SD = 12%) at baseline to 47% (SD = 15%) at follow-up. Mean scores of physical therapists with a specialization in geriatrics were higher. Level of adoption and specialization (yes/no) did not explain the variance in effectiveness. Physical therapists identified important facilitators, including tailored education and peer-assessment meetings, while adequate reimbursement for the extra time investment was considered a necessity. Different workflows in practices were perceived as a barrier. CONCLUSION: Implementation led to increased adoption and fidelity of the Coach2Move intervention by physical therapists but shows room for improvement. Attitudes towards the approach and its implementation were positive. Future implementation efforts on adoption could be improved by focusing on a fair compensation structure by third party payers and insurance companies and optimizing organizational and financial context within practices. IMPACT: This study evaluated the implementation of Coach2Move, a clinical reasoning approach designed to increase physical activity and improve self-efficacy in older adults. Overall, the study demonstrates the potential of Coach2Move to be effectively adopted by physical therapists. However, addressing therapist compensation and adapting to practice workflows are important considerations for successful large-scale implementation.

The Implementation of a Doula Grant Program Directed at Families from Economically Vulnerable Backgrounds: A Process Evaluation.

Purpose: The purpose of this study was to evaluate the process and overall feasibility of a doula grant program for expectant families from economically vulnerable backgrounds. Design: A mixed-methods process evaluation framework was utilized to examine program feasibility and focused on constructs related to fidelity, dose delivered/dose received, reach, program satisfaction, and limited efficacy testing. Measures: Evaluation constructs were measured using a program tracking document. Program satisfaction and efficacy were examined through a mixed methodology approach utilizing doula surveys and birthing parent interviews. Analysis: Related to survey data, analysis focused on presenting descriptive counts and percentages related to the number of doulas that participated and clients served. Continuous variables were calculated as means and standard deviations and categorical data as counts and percentages. Qualitative data analyses were conducted using a structured deductive thematic approach. Results: The grant program was successfully implemented over an 18-month period, and the program had a high rate of fidelity to the grant processes developed by a Midwestern-based nonprofit organization. The program was satisfactory to doulas and parents, and the largest barrier was communication. A high incidence of prenatal anxiety among the birthing parents was reported. Thematic findings from the birthing parent interviews included the following: the grant application process was effective and easy, birth doulas were greatly valued, and a financial burden was lifted. Conclusion: This grant process can be replicated by other organizations seeking to fill a gap between doula services and the economically vulnerable.

Implementation of a fluid balance control strategy in critically ill patients: POINCARE-2 trial process evaluation.

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. TRIAL REGISTRATION: Number NCT02765009.

Process evaluation of a parenting intervention for pre-schoolers with intellectual disabilities who display behaviours that challenge in the UK.

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. TRIAL REGISTRATION: NCT03086876 - https://www. CLINICALTRIALS: gov/ct2/show/NCT03086876?term=Hassiotis+Angela&draw=1&rank=1.

The feasibility, acceptability, appropriateness and impact of implementing person-centered communication for prevention of female genital mutilation in antenatal care settings in Guinea, Kenya and Somalia.

BACKGROUND: There is limited evidence on how to engage health workers as advocates in preventing female genital mutilation (FGM). This study assesses the feasibility, acceptability, appropriateness and impact of a person-centered communication (PCC) approach for FGM prevention among antenatal care (ANC) providers in Guinea, Kenya and Somalia. METHODS: Between August 2020 and September 2021, a cluster randomised trial was conducted in 180 ANC clinics in three countries testing an intervention on PCC for FGM prevention. A process evaluation was embedded, comprising in-depth interviews (IDIs) with 18 ANC providers and 18 ANC clients. A qualitative thematic analysis was conducted, guided by themes identified a priori and/or that emerged from the data. RESULTS: ANC providers and clients agreed that the ANC context was a feasible, acceptable and appropriate entry point for FGM prevention counselling. ANC clients were satisfied with how FGM-related information was communicated by providers and viewed them as trusted and effective communicators. Respondents suggested training reinforcement, targeting other cadres of health workers and applying this approach at different service delivery points in health facilities and in the community to increase sustainability and impact. CONCLUSION: These findings can inform the scale up this FGM prevention approach in high prevalence countries.

Community case management to accelerate access to healthcare in Mali: A realist process evaluation nested within a cluster randomised trial.

The Proactive Community Case Management (ProCCM) trial in Mali reinforced the health system across both arms with user fee removal, professional Community Health Workers (CHWs), and upgraded primary health centres (PHCs)-and randomized village-clusters to receive proactive home visits by CHWs (intervention) or fixed site-based services by passive CHWs (control). Across both arms, sick children's 24-hour treatment and pregnant women's four or more antenatal visits doubled, and under-five mortality halved, over three years compared to baseline. In the intervention arm, proactive CHW home visits had modest effects on children's curative and women's antenatal care utilization, but no effect on under-five mortality, compared to the control arm. We aimed to explain these results by examining implementation, mechanisms, and context in both arms. We conducted a process evaluation with a mixed method convergent design that included 79 in-depth interviews with providers and participants over two time-points, surveys with 195 providers, and secondary analyses of clinical data. We embedded realist approaches in novel ways to test, refine, and consolidate theories about how ProCCM worked, generating three context-intervention-actor-mechanism-outcome nodes that unfolded in a cascade. First, removing user fees and deploying professional CHWs in every cluster enabled participants to seek health sector care promptly and created a context of facilitated access. Second, health systems support to all CHWs and PHCs enabled equitable, respectful, quality healthcare, which motivated increased, rapid utilization. Third, proactive CHW home visits facilitated CHWs and participants to deliver and seek care, and build relationships, trust, and expectations, but these mechanisms were also activated in both arms. Addressing multiple structural barriers to care, user fee removal, professional CHWs, and upgraded clinics interacted with providers' and patients' agency to achieve rapid care and child survival in both arms. Proactive home visits expedited or compounded mechanisms that were activated and changed the context across arms.

Process evaluation of comprehensive sexuality education programme in Zambia: a focus on contextual factors, mechanisms of impact, quality of development and implementation process.

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. CONCLUSION: 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.

Acceptability of Four Intervention Components Supporting Medication Adherence in Women with Breast Cancer: a Process Evaluation of a Fractional Factorial Pilot Optimization Trial.

Adjuvant endocrine therapy (AET) reduces mortality in early-stage breast cancer, but adherence is low. We developed a multicomponent intervention to support AET adherence comprising: text messages, information leaflet, acceptance and commitment therapy (ACT), and side-effect website. Guided by the multiphase optimization strategy, the intervention components were tested in the ROSETA pilot optimization trial. Our mixed-methods process evaluation investigated component acceptability. The pilot optimization trial used a 24-1 fractional factorial design. Fifty-two women prescribed AET were randomized to one of eight experimental conditions, containing unique component combinations. An acceptability questionnaire was administered 4 months post-randomization, and semi-structured interviews with 20 participants further explored acceptability. Assessments were guided by four constructs of the theoretical framework of acceptability: affective attitude, burden, perceived effectiveness, and coherence. Quantitative and qualitative findings were triangulated to identify agreements/disagreements. There were high overall acceptability scores (median = 14-15/20, range = 11-20). There was agreement between the qualitative and quantitative findings when triangulated. Most participants "liked" or "strongly liked" all components and reported they required low effort to engage in. Between 50% (leaflet) and 65% (SMS) "agreed" or "strongly agreed," it was clear how each component would help adherence. Perceived effectiveness was mixed, with 35.0% (text messages) to 55.6% (ACT) of participants "agreeing" or "strongly agreeing" that each component would improve their adherence. Interview data provided suggestions for improvements. The four components were acceptable to women with breast cancer and will be refined. Mixed-methods and triangulation were useful methodological approaches and could be applied in other optimization trial process evaluations.