Process evaluation and its application in clinical research of acupuncture: preliminary considerations. / è¿‡ç¨‹è¯„ä»·åŠå ¶åœ¨é’ˆåˆºä¸´åºŠç ”ç©¶ä¸­åº”ç”¨çš„æ€è€ƒä¸Žå»ºè®®.

As an important supplementary approach to randomized controlled trial, process evaluation(PE) aims to evaluate implementation of complex intervention and contextual factors associated with variation in outcomes, in order to explain the observed results in a comprehensive manner. However, PE has not been well applied in the clinical research of acupuncture. Based on existing literature, this paper summarized the main methodological frameworks of PE, as well as the status-quo of its application in acupuncture research. Meanwhile, it explored the research perspectives and implementation factors that were potentially relevant to PE in parallel with acupuncture trials. In addition, the paper put forward preliminary considerations on key contents corresponding to each step during the development of PE for acupuncture trials, in order to provide useful reference and innovative pathway for future studies that strive for comprehensive evaluation of acupuncture's effect.

Process evaluation of the 'Lafiyan Yara' project on enhancing access to HIV testing services using existing community structures in Nigeria.

BACKGROUND: The Lafiyan Yara Project aimed to increase demand for HIV counselling, testing, treatment, and prevention services among pregnant women and children in Taraba State, Nigeria. Implemented from 2019 to 2021, the project utilized existing community structures, including traditional birth attendants, village health workers, and patent and proprietary medicine vendors, for mobilization. This study assessed the project's activities, contributors, relevance, effectiveness, and efficiency. METHODS: The process evaluation was conducted using focus group discussions and key informant interviews with beneficiaries, community leaders, project staff, health facility personnel, and government officials. Data analysis employed framework analysis. RESULTS: The Lafiyan Yara project was reported to have achieved notable successes, including increased HIV testing rates among children and pregnant women, improved linkage to care services, reduced mother-to-child transmission of HIV, increased HIV/AIDS awareness and knowledge, and enhanced community engagement and support. Challenges identified included insufficient funding for community mobilizers, training needs for health workers, and inadequate availability of test kits at health facilities. Confidentiality and stigma issues arose during community mobilizations. A key lesson learned was the importance of a comprehensive HIV care approach, emphasizing testing and ensuring support for individuals testing positive. CONCLUSIONS: The project's approach of leveraging community structures to create demand for HIV services among women and children proved effective, provided proper linkage to care for those testing positive. Addressing stigma and involving husbands/fathers in the community approach are crucial for improving outcomes. TRIAL REGISTRATION: IPHOAU/12/1384.

Effectiveness of group arts therapies (art therapy, dance movement therapy and music therapy) compared to group counselling for diagnostically heterogeneous psychiatric community patients: study protocol for a randomised controlled trial in mental health services (the ERA study).

BACKGROUND: Arts therapies are widely but inconsistently provided in community mental health. Whilst they are appealing to patients, evidence for their effectiveness is mixed. Trials to date have been limited to one art-form or diagnosis. Patients may hold strong preferences for or against an art-form whilst group therapies rely on heterogeneity to provide a range of learning experiences. This study will test whether manualised group arts therapies (art therapy, dance movement therapy and music therapy) are effective in reducing psychological distress for diagnostically heterogeneous patients in community mental health compared to active group counselling control. METHODS: A pragmatic multi-centre 2-arm randomised controlled superiority trial with health economic evaluation and nested process evaluation. Adults aged ≥ 18, living in the community with a primary diagnosis of psychosis, mood, or anxiety disorder will be invited to participate and provide written informed consent. Participants are eligible if they score ≥ 1.65 on the Global Severity Index of the Brief Symptom Inventory. Those eligible will view videos of arts therapies and be asked for their preference. Participants are randomised to either their preferred type of group arts therapy or counselling. Groups will run twice per week in a community venue for 20 weeks. Our primary outcome is symptom distress at the end of intervention. Secondary outcomes include observer-rated symptoms, social situation and quality of life. Data will be collected at baseline, post-intervention and 6 and 12 months post-intervention. Outcome assessors and trial statisticians will be blinded. Analysis will be intention-to-treat. Economic evaluation will assess the cost-effectiveness of group arts therapies. A nested process evaluation will consist of treatment fidelity analysis, exploratory analysis of group process measures and qualitative interviews with participants and therapists. DISCUSSION: This will be the first trial to account for patient preferences and diagnostic heterogeneity in group arts therapies. As with all group therapies, there are a number of logistical challenges to which we have had to further adapt due to the COVID-19 pandemic. Overall, the study will provide evidence as to whether there is an additive benefit or not to the use of the arts in group therapy in community mental health care. TRIAL REGISTRATION: ISRCTN, ISRCTN88805048 . Registered on 12 September 2018.

A self-directed co-creation process for developing a care pathway for patients on oral anticancer therapy: A qualitative process evaluation.

PURPOSE: To provide in-depth insight in stakeholders' experiences with the self-directed co-creation of a care pathway for patients treated with oral anticancer drugs, and to identify influencing factors for the success of the co-creation process that are persistent throughout the prior pilot phase and the scale-up phase. METHODS: This qualitative process evaluation was performed in 11 Belgian oncology departments participating in a scale-up project. Semi-structured interviews with local coordinators (n = 13) and members of the project teams (n = 19), responsible for the co-creation of the care pathway, were conducted. Data were thematically analyzed. RESULTS: Despite the external support (including group-level coaching and the use of well-defined supportive tools) to promote self-directedness, the co-creation process was perceived burdensome. Three influencing factors were persistent throughout the pilot and scale-up phase: a) shared leadership among the coordinator, physician and hospital management, b) an intrinsically motivated team driven by additional extrinsic factors, and c) a balance between external support and self-directedness. CONCLUSION: This study shows that the self-directed co-creation of a care pathway is feasible on the condition that important prerequisites are met, including shared leadership and team motivation. More concrete tools, such as a model care pathway, seem needed to increase feasibility of the self-directed co-creation of the care pathway. Yet, these tools should allow tailoring to the specific hospital context. The findings of this study can be useful for further scale-up to other oncology centers, but can also be extrapolated to other healthcare settings.

Evaluation of a community-based integrated care model (CIE) for frail older people in rural Foshan, China: study protocol for a stepped-wedge cluster randomized controlled trial {1}.

BACKGROUND: While community-based eldercare has proven to be effective in qualitative studies, there is limited evidence on the effectiveness of this geriatric care model in rural communities where caring for older people is traditionally the responsibility of family members, but a formal long-term care was recently introduced in China. CIE is a rural community-embedded intervention using multidisciplinary team, to provide evidenced-based integrated care services for frail older people including social care services and allied primary healthcare and community-based rehabilitation services. METHODS: CIE is a prospective stepped-wedge cluster randomized trial conducted at 5 community eldercare centers in rural China. The multifaceted CIE intervention, guided by chronic care model and integrated care model, consists of five components: comprehensive geriatric assessment, individualized care planning, community-based rehabilitation, interdisciplinary case management, and care coordination. The intervention is rolled out in a staggered manner in these clusters of centers at an interval of 1 month. The primary outcomes include functional status, quality of life, and social support. Process evaluation will also be conducted. Generalized linear mixed model is employed for binary outcomes. DISCUSSION: This study is expected to provide important new evidence on clinical effectiveness and implementation process of an integrated care model for frail older people. The CIE model is also unique as the first registered trial implementing a community-based eldercare model using multidisciplinary team to promote individualized social care services integrated with primary healthcare and community-based rehabilitation services for frail older people in rural China, where formal long-term care was recently introduced. TRIAL REGISTRATION {2A}: China Clinical Trials Register ( http://www.chictr.org.cn/historyversionpub.aspx?regno=ChiCTR2200060326 ). May 28th, 2022.

Delivery of index-linked HIV testing for children: learnings from a qualitative process evaluation of the B-GAP study in Zimbabwe.

BACKGROUND: Index-linked HIV testing for children, whereby HIV testing is offered to children of individuals living with HIV, has the potential to identify children living with undiagnosed HIV. The "Bridging the Gap in HIV Testing and Care for Children in Zimbabwe" (B-GAP) study implemented and evaluated the provision of index-linked HIV testing for children aged 2-18 years in Zimbabwe. We conducted a process evaluation to understand the considerations for programmatic delivery and scale-up of this strategy. METHODS: We used implementation documentation to explore experiences of the field teams and project manager who delivered the index-linked testing program, and to describe barriers and facilitators to index-linked testing from their perspectives. Qualitative data were drawn from weekly logs maintained by the field teams, monthly project meeting minutes, the project coordinator's incident reports and WhatsApp group chats between the study team and the coordinator. Data from each of the sources was analysed thematically and synthesised to inform the scale-up of this intervention. RESULTS: Five main themes were identified related to the implementation of the intervention: (1) there was reduced clinic attendance of potentially eligible indexes due to community-based differentiated HIV care delivery and collection of HIV treatment by proxy individuals; (2) some indexes reported that they did not live in the same household as their children, reflecting the high levels of community mobility; (3) there were also thought to be some instances of 'soft refusal'; (4) further, delivery of HIV testing was limited by difficulties faced by indexes in attending health facilities with their children for clinic-based testing, stigma around community-based testing, and the lack of familiarity of indexes with caregiver provided oral HIV testing; (5) and finally, test kit stockouts and inadequate staffing also constrained delivery of index-linked HIV testing. CONCLUSIONS: There was attrition along the index-linked HIV testing cascade of children. While challenges remain at all levels of implementation, programmatic adaptations of index-linked HIV testing approaches to suit patterns of clinic attendance and household structures may strengthen implementation of this strategy. Our findings highlight the need to tailor index-linked HIV testing to subpopulations and contexts to maximise its effectiveness.

An early intervention for adolescent depression targeting emotional mental images and memory specificity: a process evaluation.

We have evaluated a novel early intervention for adolescent depression (age 16-18) in a feasibility randomised controlled trial. This nested process evaluation aimed to understand how this complex intervention worked. We sought to understand participants' views and experiences of receiving and interacting with the intervention to evaluate whether the underpinning theoretical basis of the intervention is justified and whether it contributes to valued outcomes for participants. Twelve participants were invited to take part in semi-structured interviews. Framework analysis was employed to identify important aspects of adolescents' experiences. The active ingredients identified by participants were consistent with and extended our understanding of the theoretical basis of the intervention. Four principle themes were identified: understanding how memory works and being able to remember memories in more detail; processing negative experiences and letting go; imagining positive future events; and understanding and being kinder to myself. The outcomes of the intervention were valued by participants. Six principle themes were identified: improving mood and well-being; reducing impact of negative memories; motivation and goal-directed behaviour; overcoming avoidance and rumination; relationships, communication and being open; and self-understanding and acceptance. A simplified logic model is also proposed to connect the intervention components, active ingredients, and valued outcomes. The findings provide an in-depth understanding of how participants interacted with the intervention and what they derived from it. For example, the findings establish processing negative experiences as a core intervention component, extend it to include letting go of these memories, and highlight that reducing the impact of negative memories is valued by participants. This richer understanding guides further intervention development and future implementation.

"I wouldn't have joined if it wasn't online": understanding older people's engagement with teleyoga classes for fall prevention.

BACKGROUND: Yoga-based exercise is a promising strategy for promoting healthy ageing, with the potential to reduce falls and increase physical, cognitive and psychological wellbeing. Teleyoga (real-time yoga provided via interactive videoconferencing) can deliver yoga programs at scale, potentially reducing costs, increasing convenience, and reaching people who cannot attend studio-based classes. But better understanding of how older people perceive and engage with teleyoga is needed to optimise its design, implementation and promotion. METHODS: This study built on a previous realist process evaluation of the SAGE yoga trial which is testing the effect of a yoga-based exercise program on falls among 700 community-dwelling people aged 60 + years. In this second phase of evaluation we conducted focus groups with participants who had completed the SAGE program online and with the yoga instructors who were delivering it. We also conducted interviews with participants who had withdrawn from the trial. Six program theories developed in the earlier evaluation provided a framework for data analysis, supplemented by inductive coding and an analytical workshop. RESULTS: Participants described physical and psychological benefits from the SAGE teleyoga program. While noting that teleyoga cannot facilitate hands-on correction or the same quality of observation or interaction as studio classes, participants were highly appreciative of their yoga instructors' strategies for optimising visibility, instruction, social connection and therapeutic alliance, and for adapting to constrained home environments. Some participants argued that teleyoga was superior to studio classes due to its accessibility and convenience, its lower exposure to potential embarrassment about physical appearance or capabilities, and a reduced sense of peer competition and distraction. Our program theories applied across studio and online modes of delivery. CONCLUSION: Teleyoga increases accessibility for people in diverse locations and circumstances; it provides a psychologically safer space which combats self-consciousness and unwanted competitiveness; it may enhance embodiment and mindfulness for some; and it has the potential to be offered relatively cheaply at scale which could support free or reduced price classes for people on low incomes and pensions, thereby encouraging a wider population to engage in yoga for healthy ageing and fall prevention.

A Music Therapy Intervention for Refugee Children and Adolescents in Schools: A Process Evaluation Using a Mixed Method Design.

Refugee children and adolescents have often experienced negative or traumatic events, which are associated with stress and mental health problems. A specific music therapy intervention is developed for this group in school settings. The aim of the present study was to set the first steps in the implementation of this intervention. A process evaluation was performed using a mixed method design among refugee children and adolescents (6-17 years) at three different schools in the Netherlands. Interviews were conducted with teachers and music therapists before, at the midpoint, and after the intervention. At these moments, children completed a classroom climate questionnaire and a visual analogue scale on affect. The results indicate that the intervention strengthens the process of social connectedness, resulting in a "sense of belonging". The intervention may stimulate inclusiveness and cultural sensitivity, and may contribute to a safe environment and the ability of teachers to adapt to the specific needs of refugee children. Refugee children and adolescents showed a decrease of negative affect during the intervention. When implementing the intervention in schools, it is important to take into account the initial situation, the prerequisites for the intervention, the professional competence, the experience of music therapists, and the collaboration and communication between the professionals involved.

Parent-administered pediatric tuina for the treatment of attention deficit hyperactivity disorder symptoms: Process evaluation of a pilot randomized controlled trial.

BACKGROUND: A pilot randomized controlled trial (RCT) was conducted in mainland China to examine the feasibility, acceptability, and preliminary effects of parent-administered pediatric tuina on attention deficit hyperactivity disorder (ADHD) symptoms in preschool children. An embedded process evaluation was performed to explore barriers and facilitators in the implementation, identify additional questions, and refine the study design for a future fully powered study. METHODS: The process evaluation comprises the following parts: (a) self-reported questionnaires on parents (n = 43), traditional Chinese medicine (TCM) practitioners (n = 2), outcome assessor (n = 1), and research assistant (n = 1); (b) parent logbook on parent-administered pediatric tuina (n = 32); and (c) focus group interview sessions (n = 15). Accomplishment of the self-report questionnaires was voluntary for all participants and compulsory for research personnel and TCM practitioners. The parent logbook on the intervention was filled out by all participants in the intervention group. Participants of focus group interviews were selected via purposive sampling, and data were analyzed with template analysis. Qualitative findings were summarized in tables, while the mean was calculated to reflect the quantitative findings. RESULTS: Perceived benefits, acceptability of parents and children, and professional support from the research team facilitated the implementation of the intervention. Meanwhile, the TCM pattern identification using online mode may limit the accuracy and lead to parents doubting the precision of the TCM pattern. This limitation was regarded as a major barrier. Parents perceived improvements in terms of children's appetite, sleep quality, and parent-child relationship. Participants were generally satisfied with the settings of parent-administered pediatric tuina and showed satisfactory adherence to the implementation. CONCLUSIONS: Implementation of parent-administered pediatric tuina intervention is feasible and acceptable. The intervention can be refined by improving the TCM pattern identification procedure and adjusting outcome settings in a fully powered study in the future.

School-based mindfulness training in early adolescence: what works, for whom and how in the MYRIAD trial?

BACKGROUND: Preventing mental health problems in early adolescence is a priority. School-based mindfulness training (SBMT) is an approach with mixed evidence. OBJECTIVES: To explore for whom SBMT does/does not work and what influences outcomes. METHODS: The My Resilience in Adolescence was a parallel-group, cluster randomised controlled trial (K=84 secondary schools; n=8376 students, age: 11-13) recruiting schools that provided standard social-emotional learning. Schools were randomised 1:1 to continue this provision (control/teaching as usual (TAU)), and/or to offer SBMT ('.b' (intervention)). Risk of depression, social-emotional-behavioural functioning and well-being were measured at baseline, preintervention, post intervention and 1 year follow-up. Hypothesised moderators, implementation factors and mediators were analysed using mixed effects linear regressions, instrumental variable methods and path analysis. FINDINGS: SBMT versus TAU resulted in worse scores on risk of depression and well-being in students at risk of mental health problems both at post intervention and 1-year follow-up, but differences were small and not clinically relevant. Higher dose and reach were associated with worse social-emotional-behavioural functioning at postintervention. No implementation factors were associated with outcomes at 1-year follow-up. Pregains-postgains in mindfulness skills and executive function predicted better outcomes at 1-year follow-up, but the SBMT was unsuccessful to teach these skills with clinical relevance.SBMT as delivered in this trial is not indicated as a universal intervention. Moreover, it may be contraindicated for students with existing/emerging mental health symptoms. CLINICAL IMPLICATIONS: Universal SBMT is not recommended in this format in early adolescence. Future research should explore social-emotional learning programmes adapted to the unique needs of young people.

A study protocol of the adaptation and evaluation by means of a cluster-RCT of an integrated workplace health promotion program based on a European good practice.

BACKGROUND: An integrated workplace health promotion program (WHPP) which targets multiple lifestyle factors at different levels (individual and organizational) is potentially more effective than a single component WHPP. The aim of this study is to describe the protocol of a study to tailor a European good practice of such an integral approach to the Dutch context and to evaluate its effectiveness and implementation. METHODS: This study consists of two components. First, the five steps of the Map of Adaptation Process (MAP) will be followed to tailor the Lombardy WHP to the Dutch context. Both the employers and employees will be actively involved in this process. Second, the effectiveness of the integrated Dutch WHPP will be evaluated in a clustered randomized controlled trial (C-RCT) with measurements at baseline, 6 months and 12 months. Clusters will be composed based on working locations or units - dependent on the organization's structure and randomization within each organization takes place after baseline measurements. Primary outcome will be a combined lifestyle score. Secondary outcomes will be the separate lifestyle behaviors targeted, stress, work-life balance, need for recovery, general health, and well-being. Simultaneously, a process evaluation will be conducted. The study population will consist of employees from multiple organizations in different industry sectors. Organizations in the intervention condition will receive the integrated Dutch WHPP during 12 months, consisting of an implementation plan and a catalogue with activities for multiple lifestyle themes on various domains: 1) screening and support; 2) information and education; 3) adjustments in the social, digital or physical environment; and 4) policy. DISCUSSION: The MAP approach provides an appropriate framework to systematically adapt an existing WHPP to the Dutch context, involving both employers and employees and retaining the core elements, i.e. the catalogue with evidence-based activities on multiple lifestyle themes and domains enabling an integrated approach. The following process and effect evaluation will contribute to further insight in the actual implementation and effectiveness of the integrated WHP approach. TRIAL REGISTRATION: NTR (trialregister.nl ), NL9526. Registered on 3 June 2021.

Parent-administered pediatric Tuina for attention deficit/hyperactivity disorder symptoms in preschool children: A pilot randomized controlled trial embedded with a process evaluation.

BACKGROUND: Beneficial effects of parent-administered pediatric tuina on ADHD in children have been reported in previous studies, but no rigorously designed randomized controlled trials (RCTs) have been conducted on it. OBJECTIVE: To assess the feasibility and preliminary effects of parent-administered pediatric tuina for ADHD symptoms in preschoolers. METHODS: This project was a two-arm, parallel, open-label, pilot RCT. Sixty-four participants were randomized into two groups at a 1:1 ratio. Parents in the parent-administered tuina group (n = 32) attended an online training program on pediatric tuina for ADHD and conduct this intervention on their children at home. Parents in the parent-child interaction group (n = 32) attended an online training about progressive muscle relaxation exercise and carried out parent-child interactive physical activities with their children at home. Both interventions were carried out every other day during a two-month intervention period, with each manipulation for at least 20 min. Feasibility outcomes included recruitment rate, consent rate, participants' adherence, retention rate, and adverse event. Outcomes were assessed at baseline, week 4, and week 8. The primary outcome measure was the Swanson, Nolan, and Pelham parent scale (SNAP); the secondary outcomes included preschool anxiety scale, children's sleep habits questionnaire, and parental stress scale. A mixed-method process evaluation embedded within the outcome evaluation was performed. RESULTS: The recruitment rate was 12.8 per month. The consent rate was 98.5%. Good adherence was shown from the parent logbook. Four participants withdraw from the study. No severe adverse event was reported. For the SNAP total score, both groups showed improvement with moderate within-group effect size (Cohen's d > 0.5, all p < 0.001) and the between-group effect size was minimal (dppc2< 0.2, p > 0.05). Perceived improvements on children's appetite and sleep quality, and parent-child relationship was observed from the qualitative data. CONCLUSIONS: The study design and the parent-administered pediatric tuina intervention were feasible. Parent-administered pediatric tuina provided beneficial effects on improving core hyperactivity/impulsivity symptoms in preschool children. Parents perceived improvements on children's appetite and sleep quality. Further large-scale are warranted.

Contextual factors influencing advance care planning in home care: process evaluation of the cluster-randomised controlled trial STADPLAN.

BACKGROUND: The STADPLAN study is a cluster-randomised controlled trial including 27 home care services in Germany. It assesses the effect of an advance care planning (ACP) intervention delivered by trained nurses to older care-dependent patients. Patients received two ACP conversations and an information brochure. Nurses were educated through a two-day programme and topic guides structuring the conversations. Objectives of the process evaluation were to determine: [1] whether the intervention was implemented as planned, [2] which change mechanisms were observed, [3] whether targeted process outcomes were achieved and [4] in which way contextual factors influenced the implementation process. METHODS: The process evaluation is based on a mixed methods approach following the recommendations of the UK-MRC framework for the development and evaluation of complex interventions. Qualitative and quantitative assessments were developed and analysed guided by a logic model comprising intervention, participants, mechanisms of change and context factors. The results of the main trial will be published elsewhere. RESULTS: Educational programme and topic guides were mostly implemented as planned and resulted in motivation, knowledge, and perceived competencies to facilitate ACP conversations in nurses. Deviances in the performance of ACP conversations indicated patients' varied individual needs, but also obstacles like reluctance of patients and caregivers to participate actively and time constraints of nurse facilitators. Patients and caregivers reported increased awareness of ACP, planning and other activities indicating that targeted process outcomes could be achieved. The relevance of multifaceted contextual factors acting as barriers or facilitators for the engagement in ACP interventions on the individual, organisational and macro level was evident. CONCLUSIONS: The process evaluation elicits obstacles and achievements of the ACP intervention. The logic model organised a plethora of mixed methods data into a holistic picture of multifaceted results. Nurses as ACP facilitators in home care can fulfil a crucial initiating role based on a trusting relationship with their patients. To support older care-dependent people's ACP engagement, access should be simplified. Furthermore, education for nurse facilitators and sufficient resources for service provision are needed. Independent of monetary reimbursement, healthcare providers must respect patients' choice for or against any ACP intervention. ETHICS AND TRIAL REGISTRATION: Approved by the Ethics Committees of Martin Luther University Halle-Wittenberg (Ref.-No. 2019-045), Carl von Ossietzky University Oldenburg (Ref.-No. 2019-024), and University of Lübeck (Ref.-No. 19-080). GERMAN CLINICAL TRIALS REGISTER: DRKS00016886. Registered retrospectively 04/06/2019, first participant included 29/05/2019.

The UK stand together trial: protocol for a multicentre cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of KiVa to reduce bullying in primary schools.

BACKGROUND: Reducing bullying is a public health priority. KiVa, a school-based anti-bullying programme, is effective in reducing bullying in Finland and requires rigorous testing in other countries, including the UK. This trial aims to test the effectiveness and cost-effectiveness of KiVa in reducing child reported bullying in UK schools compared to usual practice. The trial is currently on-going. Recruitment commenced in October 2019, however due to COVID-19 pandemic and resulting school closures was re-started in October 2020. METHODS: Design: Two-arm pragmatic multicentre cluster randomised controlled trial with an embedded process and cost-effectiveness evaluation. PARTICIPANTS: 116 primary schools from four areas; North Wales, West Midlands, South East and South West England. Outcomes will be assessed at student level (ages 7-11 years; n = approximately 13,000 students). INTERVENTION: KiVa is a whole school programme with universal actions that places a strong emphasis on changing bystander behaviour alongside indicated actions that provide consistent strategies for dealing with incidents of bullying. KiVa will be implemented over one academic year. COMPARATOR: Usual practice. PRIMARY OUTCOME: Student-level bullying-victimisation assessed through self-report using the extensively used and validated Olweus Bully/Victim questionnaire at baseline and 12-month follow-up. SECONDARY OUTCOMES: student-level bullying-perpetration; student mental health and emotional well-being; student level of, and roles in, bullying; school related well-being; school attendance and academic attainment; and teachers' self-efficacy in dealing with bullying, mental well-being, and burnout. SAMPLE SIZE: 116 schools (58 per arm) with an assumed ICC of 0.02 will provide 90% power to identify a relative reduction of 22% with a 5% significance level. RANDOMISATION: recruited schools will be randomised on 1:1 basis stratified by Key-Stage 2 size and free school meal status. Process evaluation: assess implementation fidelity, identify influences on KiVa implementation, and examine intervention mechanisms. Economic evaluation: Self-reported victimisation, Child Health Utility 9D, Client Service Receipt Inventory, frequency of services used, and intervention costs. The health economic analysis will be conducted from a schools and societal perspective. DISCUSSION: This two-arm pragmatic multicentre cluster randomised controlled trial will evaluate the KiVa anti-bullying intervention to generate evidence of the effectiveness, cost-effectiveness and scalability of the programme in the UK. Our integrated process evaluation will assess implementation fidelity, identify influences on KiVa implementation across England and Wales and examine intervention mechanisms. The integrated health economic analysis will be conducted from a schools and societal perspective. Our trial will also provide evidence regarding the programme impact on inequalities by testing whether KiVa is effective across the socio-economic gradient. TRIAL REGISTRATION: Trials ISRCTN 12300853 Date assigned 11/02/2020.

Latent profile analysis as a method for process evaluations: Discovering response subgroups in a mindfulness intervention.

RATIONALE: Clustering techniques have been used within intervention studies to locate any distinct subgroups among intervention participants. One way in which they have not yet been utilized, but for which there is potential benefit, is in finding different motivational and behavioral response types to a newly introduced behavior. OBJECTIVE: This study aimed to use latent profile analyses (the same as latent class analyses except with continuous indicator variables) to identify 1) types, or classes, in terms of social cognitive responses to a mindfulness intervention, using The Reasoned Action Approach constructs, and 2) longitudinal/change trajectory classes of the target behavior (i.e., mindfulness practice). METHODS: The data derived from a school-based mindfulness intervention (N = 1646) among 12-15 year-olds, conducted in southern Finland from 2014 to 2016. We explored associations between the identified classes and with gender, linguocultural group, and mental health and practice outcomes. RESULTS: Analyses indicated a solution of five latent classes for both social cognition post-intervention-Uncertain but Positive (40.2%), Acceptable but No (18.8%), Indifferent (16.8), Inclined (15.5%), Disinclined (8.6%)-and practice trajectories-Stable Low (52.1%), Decreased from Seldom (25.8%), Decreased from Sometimes (10.7%), Increased from Zero (6.8%), Increased from Seldom (4.6%). The strongest differentiating theoretical construct among the social cognitive classes was a descriptive norm. The classes were characterized by some associations between each other (e.g., "Acceptable but No" and "Stable Low") and with linguocultural groups (e.g., "Inclined" and small language minorities) and mental health (e.g., "Disinclined" and externalization and depressive symptoms), but no specific associations were found by gender. CONCLUSIONS: This study shows how more person-centered analyses can be utilized in process evaluations, which predominantly only make use of variable-centered analyses. This knowledge could suggest ways to tailor universal interventions for subgroups with different receipt profiles and thereby improve intervention acceptability and engagement.

Evaluation of a program for routine implementation of shared decision-making in cancer care: results of a stepped wedge cluster randomized trial.

BACKGROUND: Shared decision-making (SDM) is preferred by many patients in cancer care. However, despite scientific evidence and promotion by health policy makers, SDM implementation in routine health care lags behind. This study aimed to evaluate an empirically and theoretically grounded implementation program for SDM in cancer care. METHODS: In a stepped wedge design, three departments of a comprehensive cancer center sequentially received the implementation program in a randomized order. It included six components: training for health care professionals (HCPs), individual coaching for physicians, patient activation intervention, patient information material/decision aids, revision of quality management documents, and reflection on multidisciplinary team meetings (MDTMs). Outcome evaluation comprised four measurement waves. The primary endpoint was patient-reported SDM uptake using the 9-item Shared Decision Making Questionnaire. Several secondary implementation outcomes were assessed. A mixed-methods process evaluation was conducted to evaluate reach and fidelity. Data were analyzed using mixed linear models, qualitative content analysis, and descriptive statistics. RESULTS: A total of 2,128 patient questionnaires, 559 questionnaires from 408 HCPs, 132 audio recordings of clinical encounters, and 842 case discussions from 66 MDTMs were evaluated. There was no statistically significant improvement in the primary endpoint SDM uptake. Patients in the intervention condition were more likely to experience shared or patient-lead decision-making than in the control condition (d=0.24). HCPs in the intervention condition reported more knowledge about SDM than in the control condition (d = 0.50). In MDTMs the quality of psycho-social information was lower in the intervention than in the control condition (d = - 0.48). Further secondary outcomes did not differ statistically significantly between conditions. All components were implemented in all departments, but reach was limited (e.g., training of 44% of eligible HCPs) and several adaptations occurred (e.g., reduced dose of coaching). CONCLUSIONS: The process evaluation provides possible explanations for the lack of statistically significant effects in the primary and most of the secondary outcomes. Low reach and adaptations, particularly in dose, may explain the results. Other or more intensive approaches are needed for successful department-wide implementation of SDM in routine cancer care. Further research is needed to understand factors influencing implementation of SDM in cancer care. TRIAL REGISTRATION: clinicaltrials.gov, NCT03393351 , registered 8 January 2018.

Process evaluation of integrated West Nile virus surveillance in northern Italy: an example of a One Health approach in public health policy.

West Nile virus (WNV) is endemic in the Po valley area in northern Italy. Regional health authorities have implemented integrated WNV surveillance following a One Health approach, based on collaboration between human, animal and environmental health institutions. We evaluated this integrated WNV surveillance system in Emilia-Romagna, Lombardy and Piedmont regions by means of a process evaluation. We examined the system's implementation fidelity, dose delivered and received, reach, and we identified strengths and weaknesses in the system. Qualitative and semi-quantitative data were obtained from three regional focus groups. Data were discussed in a follow up focus group, where participants suggested recommendations for improving the surveillance system. Inter-institutional and interdisciplinary integration and the creation of a 'community of practice' were identified as key elements for effective surveillance. We identified differences in the degree of interdisciplinary integration in the three regions, likely due to different epidemiological situations and years of experience in surveillance implementation. Greater collaboration and sharing of information, public engagement and economic assessments of the integrated surveillance approach would facilitate its social recognition and guarantee its sustainability through dedicated funding. We demonstrate that a transdisciplinary research approach based on process evaluation has value for designing and fine-tuning integrated health surveillance systems.

A process evaluation of the Mind Your Back trial examining psychologically informed physical treatments for chronic low back pain.

BACKGROUND: In chronic conditions, such as back pain, the use of interventions that address physical, social and psychological aspects within a biopsychosocial framework are encouraged, however, applying this holistic multimodal approach in physical therapy practice (i.e., chiropractic and physiotherapy) is challenging. To explore the problem of delivering a biopsychosocially informed package of care in physical therapy practice a recent randomised control trial (RCT) called 'Mind Your Back' was conducted to evaluate the effectiveness of a combined physical and internet-delivered psychological intervention (psychologically informed physical treatments) compared to standard treatment for improving disability and self-efficacy in people with chronic LBP. The results of the trial indicated no difference between the two intervention groups. Although high-quality RCTs are considered gold standard for effectiveness of interventions, qualitative research methods embedded within a process evaluation framework are also used to reveal other issues and important information that help to explain clinical trial results, and to further the field of digital health interventions research. Therefore, within a process evaluation framework, the aim is to explore participants experiences of the interventions received throughout the Mind Your Back trial which led to a null result. METHODS: In-line with recommendations for a process evaluation this study used in-depth interviews and qualitative thematic analysis with participants of both arms of the trial 5-6 months after study completion. Semi-structured telephone interviews were conducted with twenty-five participants to explore their experiences of taking part in the Mind Your Back trial. Interviews were conducted in November 2017, transcribed verbatim and data analysed thematically. RESULTS: Two main themes were identified: (1) Personalised support and therapeutic alliance are important, and (2) MoodGYM lacked relevant, personalised and tailored support. CONCLUSION: It is important to deliver tailored digital health supports that is personalised and fosters a therapeutic alliance.

Process Evaluation of a Farm-to-WIC Intervention.

BACKGROUND: Despite the promise of farm-to-institution interventions for addressing limited vegetable access as a barrier to intake, programs designed for the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) are lacking. As such, little is known about the implementation of, and mechanisms of action through which, farm-to-WIC interventions affect vegetable intake and participant satisfaction with such programs. OBJECTIVE: To examine whether a farm-to-WIC intervention to promote vegetable intake was implemented as intended, differences between participants who received the intervention relative to those in a usual-care control group in intermediate outcomes of vegetable-related knowledge, attitudes, and behaviors, and secondary outcomes of physical activity and weight status; and participant satisfaction with the intervention. DESIGN: A process evaluation encompassing descriptive and comparative analyses of implementation fidelity logs and survey data collected as part of a pilot study was conducted. PARTICIPANTS/SETTING: The setting was a large, New Jersey-based, urban WIC agency. Recruited between June 3 and August 1, 2019 through 3 of the agency's 17 sites (1 intervention and 2 control sites), participants were 297 primarily Hispanic adults (160 enrolled at the intervention site and 137 at control sites). INTERVENTION: The intervention combined behaviorally focused instruction and handouts with the introduction of a WIC-based farmers' market, field trips to an area farmers' market, telephone coaching and support, and recipe demonstrations and tastings. MAIN OUTCOME MEASURES: Primary outcomes were vegetable intake (measured via self-report and objectively using dermal carotenoids as a biomarker of intake) and the redemption of vouchers provided by WIC for fruit and vegetable purchases at farmers' markets (measured objectively using data provided by WIC). For the process evaluation, logs were used to document program activities. Vegetable-related knowledge, attitudes, and behaviors, physical activity, and satisfaction with the intervention were assessed with participant questionnaires. Weight status was assessed with direct measures of height and weight. Data were collected at baseline and at mid- and post-intervention (3 and 6 months post-baseline, respectively). STATISTICAL ANALYSES PERFORMED: Descriptive statistics were used to characterize implementation fidelity. Associations between intermediate and secondary outcomes and vegetable intake were examined at baseline with Pearson correlations. Post-baseline between-group differences in the outcomes were examined with linear mixed-effects models adjusted for baseline values and covariates. Satisfaction with the intervention was assessed with inferential and thematic analyses. RESULTS: Post-intervention, measures of vegetable intake were higher in the intervention relative to the control study group. Receipt of the intervention was also associated with a greater likelihood of voucher redemption. Nearly all participants (≥94%) received the intervention as intended at the WIC-based farmers' market; smaller percentages completed 1 or more planned trips to the area farmers' market (28%) and telephone coaching and support calls (88%). Although most intermediate and secondary outcomes were associated with measures of vegetable intake at baseline, the variables did not differ between study groups post-intervention. Mean satisfaction ratings were ≥6.8 on a 7-point scale. Recipe demonstrations, learning about vegetables, field trips, and the rapport with staff were liked most about the program. Although adding days and times for field trips was suggested, limited market days and hours of operation limited the ability to do so. CONCLUSIONS: Preliminary data highlight the promise of this well-received intervention. Intermediate outcome findings suggest that other potential intervention mechanisms of action should be considered in future large-scale trials of this program. Broad-scale initiatives are needed to improve access to farmers' markets in underserved communities.