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.
BACKGROUND: ISRCTN, ISRCTN reference: 10,133,661. Registered 23rd November 2018.

OBJECTIVE: 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.
METHODS: 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.
CONCLUSIONS: Group-based pelvic floor muscle training may have the potential of reducing the prevalence of urinary incontinence in pregnant women with insufficient healthcare professionals.
CONCLUSIONS: 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.
UNASSIGNED: The study has adhered to CONSORT guidelines (Table S1) and TIDier checklist (Table S2).
UNASSIGNED: 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.
BACKGROUND: 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\'.

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.
METHODS: 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.
METHODS: 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.
METHODS: The primary outcome of the pilot cluster RCT (cRCT) will be whether progression to a phase III RCT is justified.
CONCLUSIONS: 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.
BACKGROUND: Researchregistry8699. Registered 21st February 2023.

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).
CONCLUSIONS: 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.
BACKGROUND: 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 ).

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.

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.

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.

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.

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.