Fidelity Of Delivery Research Articles

Stroke rehabilitation is essential, yet many stroke survivors receive insufficient therapy, particularly for arm function. The 2023 UK National Stroke Guidelines recommend ongoing rehabilitation, but resource constraints limit therapy intensity. Digital interventions, such as OnTrack-a wearable system co-designed with stroke survivors, carers and therapists-offer a scalable self-management solution for rehabilitation. This study evaluates the feasibility of implementing OnTrack within NHS stroke services and informs a future RCT. A two-arm, parallel-group randomised feasibility trial conducted across three NHS sites. Stroke survivors (n = 30) with arm weakness within 12months post-stroke were randomised 1:1 to receive either OnTrack plus usual care or usual care alone. The primary outcome was the recruitment rate. Secondary feasibility outcomes included retention, adherence, and intervention fidelity. Secondary clinical measures assessed arm function (MAL-14), self-efficacy (SSEQ), quality of life (EQ-5D-5L), and usability (SUS). A process evaluation explored intervention fidelity and implementation experiences. A preliminary economic evaluation examined data collection feasibility using the Client Service Receipt Inventory (CSRI) and a per-patient costing of the OnTrack intervention. Thirty participants out of a target of 42 (71.4%) were randomised, with 24/30 (80%) retained at 12weeks. Intervention adherence was high with participants engaging with OnTrack an average of 6.3days per week (90.7%). Fidelity of intervention delivery was modest (53.9%), highlighting areas for therapist training improvements. Trends suggested improvements in arm function and self-efficacy across groups. The preliminary economic evaluation confirmed the feasibility of data collection using CSRI, though limitations in accuracy and completeness were identified. A per-patient costing of the OnTrack intervention was achieved. Apparent cost differences between groups, identified through a preliminary cost-consequence analysis, were influenced by an unbalanced distribution of reported service use and should be interpreted with caution. UPBEAT demonstrated the feasibility of delivering OnTrack in NHS stroke services, with strong retention and adherence. Findings support the potential for a future full-scale RCT, with refinements needed in recruitment procedures, therapist training, and economic data collection methods. Digital self-management tools like OnTrack may offer a scalable approach to increasing rehabilitation intensity, addressing gaps in stroke recovery pathways. UPBEAT Feasibility Trial, IRAS: 323576, CPMS: 59352. Approved by London Surrey REC on 14/12/2023.

Assessing fidelity is essential to understanding the effectiveness of behavioural interventions, yet reporting often lacks detail and consistency. This study developed and applied a fidelity checklist to evaluate both training and treatment delivery in a school-based health education intervention. This is one of the first applications of The Behaviour Change Technique Ontology to inform the development of a fidelity checklist. The checklist was created for the 11 for Health (11fH) intervention-an intervention shown to be effective in improving health for youth. Two fidelity checklists were developed, one for health education sessions and one for football sessions. The checklists comprised 24 behaviour change techniques (BCTs) identified in the intervention manual and intervention components identified by intervention creators. Training fidelity and treatment delivery were coded by three independent raters through 8 h of video observations of the training and 10 video observations of 45 min each of the delivery of the 11fH sessions using the checklists. Kappa coefficients indicated moderate to substantial observer agreement. The fidelity of training was 98.9% and the fidelity of delivery was 77.5%. Fidelity was high for items such as 'Instruct how to perform a behaviour' and 'Student inclusion', whereas the BCTs 'Inform about emotional and social consequences' and 'Substitute one behaviour with another' were delivered with lower fidelity. We provide a template of how to develop and evaluate aspects of fidelity that can be used in similar health education interventions, thereby enhancing both their evaluation and implementation.

BackgroundWhen implementing multicomponent interventions, fidelity to the intervention is key for reproducible outcomes. This study investigates the main influences on the fidelity (implementation strategy fidelity and intervention delivery fidelity) of the community-based Falls Management Exercise (FaME) programmes in three different areas of England.MethodsFaME classes across Greater Manchester (GM), Devon and the East Midlands (EM) were studied between 2021 and 23 using a mixed-methodological approach. Data sources included interviews, observations of FaME classes, field notes, and communities of practice recordings.ResultsForty interviews were conducted with stakeholders, providers and class attendees. Additionally, twenty-one class observations were conducted. Triangulated quantitative and qualitative data revealed issues with fidelity to the FaME programme, especially in sites with limited oversight roles/structures and limited funding. There was a lack of understanding and clarity of essential components which impacted both implementation strategy and intervention delivery fidelity. The conceptual map developed highlights the importance of mediators of fidelity in relation to implementation and delivery, including: economic influence, organisational influence, oversight roles, fidelity evaluation, participant responsiveness, essential components and knowledge, training and professionalism.ConclusionDespite a recognised need for implementing evidence-based falls prevention programmes, a lack of sufficient funding, formalised oversight roles/structures and understanding of essential intervention components is associated with lower fidelity to the intervention. Unchecked by local monitoring, this can lead to an incremental migration of delivery away from the evidence base. We recommend: (i) providers have clarity on essential intervention components, (ii) standardised fidelity monitoring based on essential components, and (iii) effective local oversight roles and structures.Supplementary InformationThe online version contains supplementary material available at 10.1186/s12913-025-13550-7.

BackgroundThe Engaging Adolescents in Changing Behaviour trial tested the impact of an adolescent diet and physical activity intervention involving: teacher training in Healthy Conversation Skills, a health education module (LifeLab) and a gamified smartphone application (‘the app’). The process evaluation described in this paper examined the implementation, context and mechanisms of impact of the intervention (the core elements of the Medical Research Council guidance on process evaluation of complex interventions), to identify how and why participants did or did not engage with each element of the trial and the intervention.MethodsA mixed-methods approach was employed. 51 interviews with students, teachers and parents from 11 secondary schools were conducted and analysed using thematic analysis. Quantitative data reported numbers of students who attended LifeLab and downloaded and used the app.Results87.9% of eligible students attended LifeLab and 45.7% of eligible students downloaded the app. Students (n=72) and teachers (n=16) had positive experiences of LifeLab and the teacher training, despite the pandemic preventing in-person delivery for some schools. Students engaged in a limited way with the app. Parents (n=11) had positive views of the research but little knowledge of the intervention. Students valued learning about their own health, and teachers were enthusiastic about supporting their students’ health but struggled to find opportunities to do so.ConclusionsSchools are appropriate settings in which to implement health interventions, but the research must benefit teachers and students. Most students did not engage with the app because they were not presented with it in a way that motivated them to use it. Careful consideration of the design of apps is required to encourage students to use them. Parents should be involved in research in ways that are accessible to them.

Newborn units in resource-constrained low-middle-income countries (LMICs) often have high neonatal mortality rates. Programmes to improve care quality often accept understaffing that directly affects care in these settings as a norm, and the effects of improving staff numbers are not studied. To address a major evidence gap, we examined the effects on quality of care of improving nurse staffing in four intermediate-level Kenyan newborn units. We introduced three additional nurses to each of four newborn units. We measured nursing care provision using direct bedside observations with a validated structured checklist before and 6 months after intervention. Our primary outcome, changes in nurse-delivered care, was examined using descriptive analysis and multilevel modelling to adjust for confounding. We also examined the pattern of nursing care delivery and intervention fidelity. We observed a total of 1872 hours of care, over 156 nursing shifts for 290 and 300 babies before and after our intervention, respectively, across our four neonatal units. Our intervention increased the nursing hours per patient per shift observed from 34 to 43 min associated with a 4.7% increase in our primary outcome, nurse-delivered care and an 8.4% increase in delivery of 10 tasks nurses prioritise (adjusted B-coefficient 0.047 (95% CI 0.028 to 0.066) and B-coefficient 0.084 (95% CI 0.053 to 0.115), respectively). Intervention strength was reduced by changes in existing nurses' deployment and an increase in workload. In very high workload settings in LMICs where nurses can only deliver a fraction of nursing care, staffing increases improve care delivery more obviously for high-priority tasks. These findings provide much needed evidence that increasing neonatal nurse staffing in under-resourced newborn units improves care quality.

BackgroundUkraine has experienced armed conflict since 2014, with significant escalation in 2022. Since then, an estimated 3.7 million people have been internally displaced. Alcohol misuse remains a substantial public health challenge in Ukraine, with high levels of psychological distress among the displaced population. The current study aims to evaluate the effectiveness and cost-effectiveness of a transdiagnostic intervention (CHANGE) to address alcohol misuse and psychological distress through problem-solving therapy and selected behavioural strategies for managing alcohol misuse. We hypothesize that CHANGE, together with enhanced usual care (EUC), will be more effective in increasing the percentage of days abstinent (PDA) than EUC alone.MethodsThis study is a parallel-arm, single-blind, individually randomised controlled trial across Ukraine government-controlled territories. Following informed consent, we will recruit 500 adult war-affected men, randomised 1:1 to EUC and CHANGE, or EUC alone. Inclusion criteria include elevated levels of alcohol use (between 8 and 19, inclusive, on the Alcohol Use Disorder Identification Test); psychological distress (≥ 16 on the Kessler Psychological Distress Scale) and ability to speak Ukrainian or Russian. CHANGE will be delivered over 6 weeks by 14 community-based facilitators, with outcomes assessed at 3 months post-randomisation. The primary outcome for CHANGE is the PDA from alcohol at 3 months, measured using the Timeline Follow Back. Secondary outcomes include percentage days of heavy drinking, alcohol misuse, psychological distress (depression, anxiety, and posttraumatic stress disorder), functional disability, intimate partner violence perpetration and health economics indicators at 3 months. The primary analysis will follow an intention-to-treat approach. A mixed-methods process evaluation will examine facilitator competency, recruitment, retention/completion, appropriateness, dose received, fidelity and feasibility of delivery and acceptability.DiscussionCHANGE is the first intervention aiming to address alcohol misuse and psychological distress in an active conflict setting.Trial registrationISRCTN14881856. Registered on 5th of July 2024.Supplementary InformationThe online version contains supplementary material available at 10.1186/s13063-025-09143-8.

Testing a New Diabetes Adaptive Weight management Network (NewDAWN): A protocol for a randomised controlled trial.

Emerging research has shown that pharmacist-led comprehensive medication management (CMM) can be an effective strategy for controlling hypertension. A synthesis of the evidence on the overall effects of CMM on clinical, quality, and economic outcomes could help inform and contribute to improvements in programming and practice. Presently, such a synthesis is limited in the literature. To address this gap, we conducted a scoping review of CMM effects on these outcomes, organized by 4 domains: therapeutic, humanistic, safety and economic. Using predefined search terms for articles on studies published between 2010 and 2024, we performed a literature search utilizing these terms to search the MEDLINE, Cochrane Library and CINAHL databases. For each of the identified studies, we applied a multi-stage screening process to extract data, chart results, and synthesize findings. The process took into account methodology of study design, patient population involved, CMM implementation, relevance of outcomes to clinical improvement, and factors that were deemed relevant to study selection. In total, 49 experimental, observational, and simulation-based studies were included in the scoping review. The synthesis focused on outcomes most frequently reported and those rigorously evaluated by the studies in the review. They included clinical measures of blood pressure reduction and control, frequency and duration of healthcare visits, and changes in medication therapy regimen and medication adherence. Overall, CMM interventions were found to have significantly favorable effects on systolic blood pressure reduction, hypertension control, and medication changes. Other outcomes, which showed positive effects, included self-reported patient experience and behaviors, emergency department visits, hospitalizations, mortality, and program costs and related savings from implementing a CMM program. Some results, however, were mixed. For example, a number of studies reported outcomes data without significance testing and many generally lacked consistent characterization of their programming and implementation processes. Future research and practice evaluations should include these elements in their documentation. Furthermore, a more consistent approach to implementing CMM in the field may lead to better support of program delivery fidelity, helping to optimize CMM, moving it from demonstrated efficacy to intervention effectiveness in the real world.

ObjectivesTo understand feasibility, acceptability and indicators of effectiveness of a shared decision-making (SDM) intervention with patients following an anterior cruciate ligament (ACL) rupture.DesignNon-randomised feasibility study with embedded qualitative interviews.SettingOrthopaedic and physiotherapy service at an acute National Health Service (NHS) Teaching Hospital in the Midlands, UK, between 29 January and 5 June 2024.ParticipantsPatients diagnosed with an ACL rupture following MRI.InterventionDelivery of a SDM intervention which comprised of two components: (1) patient information leaflet and (2) option grid.Outcome measuresThe primary outcome was to determine feasibility for a definitive trial using four outcomes: (1) recruitment rate, (2) fidelity of intervention delivery, (3) acceptability and (4) follow-up questionnaire completion. The secondary outcome was to explore indicators of the intervention’s effectiveness using quantitative data from patient reported outcome measures (acceptability questionnaire and satisfaction with decision scale) and qualitative data from patient and clinician interviews.Results21 patients were approached to take part in the study, 20 were recruited with a mean age of 32.2 (SD 9.7), 40% were female. The recruitment rate was 95.2%, fidelity of intervention 100%, acceptability 94% and follow-up questionnaire completion 100%. The mean overall satisfaction with decision scale score was 24.85/30 (SD 3.82). There were no adverse events. Data from qualitative interviews with patients (n=5) and physiotherapists (n=5) suggested the SDM was acceptable and appeared effective in: (1) supporting decision-making about treatment, (2) conversations between patients and clinicians, (3) improving patient knowledge, (4) providing patients with access to health language and (5) supporting patients to ask questions deemed important to them.ConclusionThe novel SDM intervention is acceptable to both patients and physiotherapists. Indicators of effectiveness explored through quantitative and qualitative data suggest the intervention to be beneficial to decision-making processes for patients and clinicians deciding on treatment following an ACL rupture. All four feasibility outcomes were achieved, indicating a full trial is feasible to run in the NHS.Trial registration numberISRCTN17801081.

ABSTRACT Objectives The Individualized Positive Psychosocial Intervention (IPPI) is an evidence-based program that engages people living with dementia (PLWD) in brief (i.e. 10 minute) one-to-one preference-based activities two times a week. This study evaluated the feasibility of pragmatically implementing a pilot embedded pragmatic clinical trial of the IPPI program in nine nursing homes. Methods Feasibility was defined as the ability of NH communities to establish implementation champions and an implementation team, complete training, identify and enroll eligible residents, match IPPI protocols to residents’ stated preferences, complete an average of two IPPIs per week per resident for 6 months, and complete IPPIs with fidelity. Results Seven NHs completed the project, enrolling a total of 130 eligible residents. Seventy staff were trained. Staff identified preferences, corresponding IPPIs, and a targeted symptom of distress for all enrolled residents. Staff completed an average of 44.71 IPPIs per person (over six months) for those that did not pass away or discharge, with an average of 3.91 days between IPPIs. All staff reached at least 80% intervention delivery fidelity. Conclusions and Clinical Implications The IPPI program is a feasible nonpharmacologic intervention for PLWD that can be implemented with fidelity over time in nursing homes by staff.

BackgroundGroup cognitive stimulation therapy (CST) has been shown to improve cognition and quality of life of people with dementia in multiple trials, but there has been scant research involving people with intellectual disability and dementia. This study aimed to assess the feasibility of conducting a randomised controlled trial of group CST for this population.AimsTo assess the feasibility of participant recruitment and retention, the appropriateness of outcome measures, and the feasibility of group CST (adherence, fidelity, acceptability), as well as the feasibility of collecting data for an economic evaluation.MethodParticipants were recruited from six National Health Service trusts in England and randomised to group CST plus treatment as usual (TAU) or TAU only. Cognition, quality of life, depression, and use of health and social care services were measured at baseline and at 8–9 weeks. Qualitative interviews with participants, carers and facilitators were used to explore facilitators of and barriers to delivery of CST. Trial registration number: ISRCTN88614460.ResultsWe obtained consent from 46 participants, and 34 (73.9%) were randomised: 18 to CST and 16 to TAU. All randomised participants completed follow-up. Completion rates of outcome measures (including health economic measures) were adequate; 75.7% of sessions were delivered, and 56% of participants attended ten or more. Fidelity of delivery was of moderate quality. CST was acceptable to all stakeholders; barriers included travel distance, carer availability and sessions needing further adaptations. The estimated cost per participant of delivering CST was £602.ConclusionsThere were multiple challenges including recruitment issues, a large dropout rate before randomisation and practical issues affecting attendance. These issues would need to be addressed before conducting a larger trial.

Survival after stroke is improving, leading to increased demand on primary care and community services to meet the long-term care needs of people living with stroke. Improving Primary Care After Stroke (IPCAS) is a novel model of primary care for stroke survivors living in the community. IPCAS was a complex intervention, with intervention components aimed at stroke survivors and healthcare professionals. This process evaluation aimed to explore how the intervention was delivered in context and how participants engaged with the intervention. The process evaluation was underpinned by the National Institute of Health's Behaviour Change Consortium fidelity framework. A mixed methods design was used to assess fidelity of design, training, delivery and engagement. Methods included questionnaires, video- and audio-recordings, observations, and interviews with staff and participants. The IPCAS intervention reflected its theoretical underpinnings and was substantially different from usual care. Most components of the intervention were delivered with high or moderate fidelity and training fidelity was high. In particular, the checklist was considered useful. However, other components were less valued, in particular, the direct point of contact service which was hardly used by participants and the local directory of services which had variable take up by healthcare professionals. It was not possible to facilitate communication between primary and secondary care as originally planned. Furthermore, some practices used a GP or healthcare assistant to deliver the reviews, rather than a practice nurse as planned. Several participants did not feel the intervention was relevant for them due to their recovery and the time that had passed since their stroke. This mixed-methods process evaluation provided novel insights into the design, delivery and engagement with a new model of primary care for stroke survivors. Despite high or moderate fidelity for delivery of most components of the intervention and high training fidelity, some components, such as the direct point of contact, were not valued and several participants did not feel the intervention was relevant for them. ClinicalTrials.gov NCT03353519. Registered on November 27, 2017.

There is an urgent need for accessible interventions to facilitate early intervention for young people with borderline personality disorder (BPD) symptoms. Existing evidence-based interventions for adolescent BPD are highly resource-intensive, and few young people with BPD symptoms have access to timely treatment. We adapted a brief psychological treatment for adolescent BPD symptoms previously provided within secondary mental health services for delivery within schools and colleges. This study aimed to assess the feasibility of evaluating the effectiveness and cost-effectiveness of this intervention (BEST (brief education support treatment)) in a future randomised controlled trial (RCT). The feasibility RCT involved 12 schools and colleges. Eligible participants were aged 13-18years and self-reported BPD symptoms above a clinical threshold and a history of repeated self-harm. Over 9months, 32 participants were randomised to receive either the BEST intervention plus treatment as usual (TAU) or TAU alone. Participants were assessed at baseline and 12 and 24weeks. A mixed-methods process evaluation was conducted. Recruitment was slower than anticipated, but participant retention was high (89.5% at 12weeks and 73.7% at 24weeks). Performance of all outcome measures was satisfactory. Fidelity of intervention delivery was high (93.5% adherent), and we did not identify any evidence of contamination of the control arm. The intervention was perceived by staff and young people as beneficial to participants, practitioners and the wider school/college and therefore highly acceptable. The study was disrupted by the closure of schools and colleges in response to the COVID-19 pandemic. This reduced the window for participant recruitment and limited data collection. The intervention was delivered successfully within schools and colleges and was acceptable to staff and young people. The findings provide support for continuing this programme of research and should inform the design of a future evaluation of intervention outcomes. ISRCTN16862589.

ABSTRACTStudies of children at high risk of dyslexia demonstrate that oral language difficulties are a major risk factor for poor reading and that children who enter school with poor language are likely to struggle to become proficient readers. We review findings of studies of oral language intervention against a backdrop of research showing that language skills are the foundation for learning to read. Language screening to identify at‐risk children, followed by language intervention delivered as a “pull‐out” program, can improve oral language skills with positive effects on later reading and behavior in school as rated by teachers. The fidelity of delivery of such programs depends upon educators receiving appropriate training and support during delivery.

National Health Service England piloted a low-calorie diet programme, delivered through total diet replacement and behaviour change support via 1 : 1, group or digital delivery, to improve type 2 diabetes in adults with excess weight. To coproduce a qualitative and economic evaluation of the National Health Service low-calorie diet pilot, integrated with National Health Service data to provide an enhanced understanding of the long-term cost-effectiveness, implementation, equity and transferability across broad and diverse populations. What are the theoretical principles, behaviour change components, content and mode of delivery of the programme, and is it delivered with fidelity to National Health Service specifications? What are the service provider, user and National Health Service staff experiences of the programme? Do sociodemographics influence programme access, uptake, compliance and success? What aspects of the service work and what do not work, for whom, in what context and why? Can the programme be improved to enhance patient experience and address inequities? What are the programme delivery costs, and policy implications for wide-spread adoption? A mixed-methods study underpinned by a realist-informed approach was delivered across five work packages, involving: semistructured interviews with service users (n = 67), National Health Service staff (n = 55), service providers (n = 9); 13 service provider focus groups; and service user surveys (n = 719). Findings were triangulated with clinical data from the National Health Service England's first cohort analysis (n = 7540). Fifty-five per cent of service users who started total diet replacement completed the programme and lost an average of 10.3 kg; 32% of those with data available to measure remission achieved it. Examination of programme mobilisation identified barriers around referral equality and the impact of COVID-19, while effective cross-stakeholder working and communication were key facilitators. Service delivery and fidelity assessments identified a drift in implementation fidelity, alongside variation in the behaviour change content across providers. Perceived barriers to programme uptake and engagement aligned across service providers and users, resulting in key learning on: the importance of person-centred care, service user support needs, improvements to total diet replacement and the social and cultural impact of the programme. Early National Health Service quantitative analyses suggest some socioeconomic variation in programme uptake, completion and outcomes. Insights from the evaluation and National Health Service data were combined to develop the programme theory and underpinning context, mechanisms and outcomes. These were used to develop a list of recommendations to improve the cultural competency of programme delivery, total diet replacement delivery, peer support and address psychological support needs. Cost-effectiveness analyses using short-term follow-up data indicated there is potential for the programme to be cost-effective, but not cost saving. The National Health Service low-calorie diet can provide a clinically effective and potentially cost-effective programme to support weight loss and glycaemic control in adults with type 2 diabetes. However, this evaluation identified areas for improvement in referral equity, uptake and completion, and fidelity of delivery, which have informed the development of the programme, which has now been rolled out nationally. Ongoing programme monitoring and long-term follow-up are now required. The real-world setting limited some data collection and analysis. Future work will focus on the analysis of long-term clinical and cost-effectiveness, and addressing inequalities. This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme as award number NIHR132075.

BackgroundPoor mental health among adolescent girls during pregnancy and the year after birth (the perinatal period) has been found to have a significant detrimental effect on girls and their children. The Innovative approaches to adolescent perinatal wellbeing (INSPIRE) project co-designed an intervention (Thriving Mamas) to improve adolescent perinatal mental health in Kenya and Mozambique. The aim of the current study is to pilot test the co-designed intervention to understand how it can be adapted for further testing or scale-up.MethodsA mixed-method, pilot cluster-randomised, effectiveness-implementation Hybrid Type II trial will be conducted among 80 adolescent girls (aged 15–19 years) attending health facilities in Kenya and Mozambique. Girls attending health facilities randomised to the intervention arm will be recruited to receive the intervention in addition to usual care. Girls attending control arm facilities will receive usual care only. Implementation data on feasibility, acceptability, appropriateness, and fidelity of intervention training and delivery will be collected from providers and adolescents. Additional data on provider knowledge, attitudes, and competency will be collected pre- and post-training. Adolescent girls will provide assessments of depression, anxiety, quality of life, social support, parenting competency, and health behaviours before, during, and after delivery of the intervention. At the end of the study, qualitative interviews will be conducted to collect further data on perceptions of the intervention, its implementation, and its impact. Implementation data will be analysed to determine its potential for delivery and success within each context. Individual outcome data analyses will be reported to gain a better understanding of the initial impact of the intervention.DiscussionThe Thriving Mamas intervention addresses the challenges to maintaining positive mental health during the perinatal period. It was co-designed with adolescents and their communities to address local priorities and needs. The results of this study will provide information on its potential for sustainable implementation as well as initial data on its impact on mental health, parenting, and health behaviour outcomes. These results will inform the further refinement of the intervention and implementation strategies as well as the design of a full trial to test their effectiveness.Trial registrationEthical approval for this feasibility study has been obtained in Kenya (Aga Khan University Institutional Scientific and Ethics Review Committee, ref: 2023/ISERC-23 (v2)), Mozambique ( Tete Inter-Institutional Health Bioethics Committee, ref: 24/CIBST/23), and the UK (Psychiatry, Nursing and Midwifery Research Ethics Committee, King’s College London, ref: HR/DP-22/23–37,125). It was registered at Clinicaltrials.gov (NCT06040359) on September 15, 2023 (https://clinicaltrials.gov/study/NCT06040359?intr=Thriving%20mamas&rank=1 ), prior to the beginning of the study.

The MELACARE intervention aimed to evaluate a nurse-led follow-up program incorporating skin self-examination (SSE) education and psychosocial support to address fear of cancer recurrence (FCR) in early-stage melanoma survivors. This study assessed the MELACARE intervention's impact on FCR, psychological well-being, SSE performance, and healthcare usage compared to standard physician-led follow-up. A two-group randomised controlled trial was conducted at Herlev and Gentofte Hospital, Denmark. Participants included 153 patients with surgically treated melanoma (stages IA-IIA). Patients were randomised to either the MELACARE intervention (n = 78) or a control group provided treatment as usual (n = 75). The intervention involved nurse-led sessions focusing on SSE techniques and metacognitive strategies. Outcomes included FCR (primary), distress, anxiety, depression, health-related quality of life (HRQoL), patient activation, and SSE frequency and confidence (secondary) at 6 months. ClinicalTrials.gov (NCT05253872). At 6 months, the mean of the primary outcome FCR was lower in the intervention compared to the control groups, but the difference was not statistically significant (- 0.86 [- 3.34;1.62]). Intervention patients reported higher HRQoL (18% [3;32]) and patient activation (0.43 [0.15;0.71]) as the only significant secondary outcomes. Confidence in SSE was higher in the intervention group, with most performing SSE at recommended intervals. The MELACARE intervention may improve HRQoL and patient activation but did not reduce FCR. High fidelity of delivery and patient adherence highlight its potential utility. The MELACARE approach empowers melanoma survivors through structured SSE education and psychosocial support. Future analyses will investigate long-term safety and efficacy.

Quality of reporting matched interventions for non-specific neck pain in randomised controlled trials and its association with trial outcomes: a secondary analysis of a systematic review.

Mindfulness-Based Programs (MBPs) are increasingly being introduced into a range of mainstream contexts such as health care, education, criminal justice, workplace, community settings, and leadership. MBPs are available in some form in every continent, and in some countries have become established as part of standard care in publicly funded health care systems and routinely embedded into school curriculums. Efficacy and effectiveness research demonstrate gold standard evidence in some areas and significant promise in others, and cost-effectiveness evaluations are encouraging. However, understanding how to assess and ensure the fidelity of program delivery is at a germinal stage. Without clear, robust, and coordinated approaches to this issue within the international field, ongoing dissemination and implementation could be compromised by variable standards of teaching skill and adherence to program form. These issues are relevant in practice contexts where approaches to teacher training internationally need to adhere to commonly held principles, understandings, and standards. They are also relevant in research contexts where assessment of intervention fidelity needs to ensure that the variable of the teaching process and curriculum is addressed in the research design and conveyed to readers in the presentation of data. In this special collection, we bring together articles reporting on research and practice on MBP intervention fidelity in teacher training, implementation, and development of governance for the emerging mindfulness-based field. This paper introduces the special collection, summarizes the papers included, and offers an analysis of where we are now as a field and of what steps are needed to further our understanding on these issues. We hope to share current best practice and catalyse new understandings and directions of inquiry that will provide a compass to navigate forward and benefit this promising field.

IntroductionAround 80% of the world’s smokers live in lower-middle income countries and smoking rates in China, Philippines and Indonesia are very high. Evidence suggests that most people begin smoking or become habitual smokers before reaching adulthood. This highlights the need for a smoking prevention intervention focused on young people. ASSIST (A Stop Smoking In Schools Trial) is a ‘peer-led’, school-based smoking prevention intervention, shown to be effective in the UK. The aim of the study is to assess the feasibility of conducting a full-scale effectiveness evaluation of an adapted version of the ASSIST intervention in China, Indonesia or the Philippines. However, due to issues with obtaining relevant approvals, China was removed from the trial with the approval of the funder and Trial Steering Committee, and the study will only be completed in Indonesia and the Philippines.Methods and analysisA feasibility mixed-methods cluster randomised controlled trial in 10 schools (six intervention, four control) in each of the two countries. Participants will be students aged c13–14 in mainstream (‘lower secondary’) schools. In addition to their usual education on smoking, intervention schools will receive the ASSIST intervention which is based on ‘diffusion of innovation’ theory, with new norms and behaviours promoted through: (1) peer modelling by locally influential individuals; and (2) information disseminated by them through their social networks. Control schools will continue with their usual education around smoking prevention.The key outcome of the study is whether prespecified progression criteria relating to recruitment, retention, acceptability and feasibility have been met in order to progress to a larger cluster randomised controlled effectiveness trial in one or more of the countries. A mixed-methods process evaluation will assess acceptability, feasibility and fidelity of intervention delivery, exposure to and reach of the intervention. The feasibility of trial processes including outcome measurement will be assessed. An economic evaluation will estimate the costs of the ASSIST intervention. Statistical analyses will focus on feasibility criteria, and qualitative data will be analysed using a framework approach. Outcomes assessed will include self-reported smoking behaviour (own and that of friends and family); vaping and other forms of nicotine use; smoking-related attitudes and knowledge; smoking norms; self-esteem; self-efficacy; (all at baseline and 7 month follow-up) and exhaled carbon monoxide concentration (at follow-up only).Ethics and disseminationThe trial has been approved by the University of Glasgow College of Medical, Veterinary and Life Sciences (MVLS) Ethics Committee (ref: 200210204), the De La Salle University Research Ethics Review Committee (ref: 2023-012C) and the Medical and Health Research Ethics Committee (MHREC); Faculty of Medicine, Public Health and Nursing; Universitas Gadjah Mada (ref: KE/FK/1205/EC/2022). The trial is sponsored by the University of Glasgow (Head of Research Regulation and Compliance—debra.stuart@glasgow.ac.uk). The sponsor will not have input in data collection, management, analysis and interpretation; write up and submissions for publication.The study findings will be disseminated through peer-reviewed publications in expert journals and conference presentations and targeted communications to schools, policymakers and the public.Trial registration numberISRCTN99140476.