Complex Interventions Research Articles

Development of a behaviour change intervention for improving physical activity amongst stroke survivors with physical disabilities: a co-design approach

BackgroundStroke survivors face many barriers to physical activity (PA). Solving physical inactivity after stroke requires a “systems-based” approach. We aimed to develop a complex intervention targeted at improving PA after stroke in Singapore using behaviour change theory and a co-design approach involving multiple stakeholders.MethodsWe carried out the intervention development in three phases: i. preparation phase, ii. co-design phase, and iii. intervention refinement phase. During the preparation phase, we conducted surveys (n = 38 stroke survivors, 71 physiotherapists and 35 exercise professionals) and interviews (n = 19 stroke survivors) to understand the factors influencing PA after stroke. The co-design phase consisted of two-co-design workshops held in August 2022 and were attended by 13 stroke survivors and 4 caregivers. Relevant domains of the Theoretical Domains Framework (TDF) and items in the Template for Intervention Description and Replication (TIDieR) checklist guided the discussion topics in the first co-design workshop. Solution prototypes such as exercise videos, arm and leg straps and information resources were shown in the second co-design workshop to gather feedback. In the intervention refinement phase, eight healthcare professionals from various sectors participated in two virtual Zoom meetings in August 2023, and used the Acceptability, Practicability, Effectiveness, Affordability, Spillover effects and Equity (APEASE) grid to rate the active ingredients in the complex intervention by considering the current healthcare landscape in terms of resources and manpower.ResultsStroke survivors and caregivers want a personalised PA program, stroke-specific PA opportunities and information resources, medical clearance, advice and help from healthcare professionals skilled in stroke care, face-to-face sessions at preferred exercise spaces, and access to adaptive equipment. A complex intervention consisting of 21 behaviour change techniques, 6 intervention functions and 8 options was developed.ConclusionsUsing behaviour change theory and a co-design approach involving multiple stakeholders, a complex intervention was developed to target physical inactivity after stroke. The intervention titled MOTIVATE is currently being tested in a type 1 hybrid effectiveness-implementation trial.

Considerations When Designing Inclusive Digital Health Solutions for Older Adults Living With Frailty or Impairments.

This viewpoint is written by authors with industrial, clinical, and academic backgrounds within medical and social sciences. The purpose is to share our experiences with digital health innovation from a sociotechnical perspective. The audience for the viewpoint is innovators, researchers, service designers, and project managers with little or some experience with theory-informed programs, complex interventions, and implementation or reorganization of sociotechnical ecosystems in health care. In digital health innovation projects, barriers related to traditions and cultures among researchers, clinicians, and industry may arise. Moreover, the final digital solutions may not always fit into existing digital ecosystems and may thus require a reorganization of how health care is provided at horizontal and vertical levels. The collaborating researchers have experience working in the field of digital health innovation for more than a decade, and we have developed and used 4 frameworks and models that are particularly relevant for theory-based complex interventions and can be used to inform inclusive co-design of digital health solutions with a sociotechnical perspective. These are (1) the 4E, a matrix to include, engage, empower, and emancipate marginalized people; (2) the GO-TO model, which can be used as a design navigator; (3) the Epital Care Model, to inform infrastructure; and (4) the Readiness and Enablement Index for Health Technology instrument, to stratify service users. From January 2021 to September 2024, we had the opportunity to apply these into practice in 4 living labs located in Denmark, Norway, the Netherlands, and Canada as a part of a European Union-funded project on "Smart Inclusive Living Environments." The goal was to cocreate a digital solution and reorganize health care services to reduce social isolation, increase health literacy, and enhance well-being for older adults living with frailty or impairments. Based on our experiences with the Smart Inclusive Living Environments project, we have formed a proposal for how design guidelines for sociotechnical innovation projects can be structured, backed up with reflections based on our experiences. With that, design guidelines should include three areas: (1) a common vocabulary including theories, frameworks, and models; (2) templates and protocols for methods, including detailed guidelines and templates for the planned development of the technologies; and (3) methods to implement and provide education and training of service users and informal and formal caregivers. In the design process, we emphasize the importance of involving relevant stakeholders in the implementation of the created design guidelines to obtain preparedness in the organizations, as well as including putative service users to ensure the likelihood of adoption. Moreover, it is important to align expectations, have a common understanding of the applied frameworks and methods, and have access to the necessary resources to reach successful results.

Implementation of digital remote postoperative monitoring in routine practice: a qualitative study of barriers and facilitators.

Remote monitoring can strengthen postoperative care in the community and minimise the burden of complications. However, implementation requires a clear understanding of how to sustainably integrate such complex interventions into existing care pathways. This study aimed to explore perceptions of potential facilitators and barriers to the implementation of digital remote postoperative monitoring from key stakeholders and derive recommendations for an implementable service. A qualitative implementation study was conducted of digital remote postoperative wound monitoring across two UK tertiary care hospitals. All enrolled patients undergoing general surgery, and all staff involved in postoperative care were eligible. Criterion-based purposeful sampling was used to select stakeholders for semi-structured interviews on their perspectives and experiences of digital remote postoperative monitoring. A theory-informed deductive-inductive qualitative analysis was conducted; drawing on normalisation process theory (NPT) to determine facilitators for and barriers to implementation within routine care. There were 28 semi-structured interviews conducted with patients (n = 14) and healthcare professionals (n = 14). Remote postoperative monitoring was perceived to fulfil an unmet need in facilitating the diagnosis and treatment of postoperative complications. Participants perceived clear benefit to both the delivery of health services, and patient outcomes and experience, but some were concerned that this may not be equally shared due to potential issues with accessibility. The COVID-19 pandemic demonstrated telemedicine services are feasible to deliver and acceptable to participants, with examples of nurse-led remote postoperative monitoring currently supported within local care pathways. However, there was a discrepancy between patients' expectations regarding digital health to provide more personalised care, and the capacity of healthcare staff to deliver on these. Without further investment into IT infrastructure and allocation of staff, healthcare staff felt remote postoperative monitoring should be prioritised only for patients at the highest risk of complications. The COVID-19 pandemic has sparked the digital transformation of international health systems, yet the potential of digital health interventions has yet to be realised. The benefits to stakeholders are clear, and if health systems seek to meet governmental policy and patient expectations, there needs to be greater organisational strategy and investment to ensure appropriate deployment and adoption into routine care. NCT05069103.

Obesity in childhood - literature review and educational recommendations

Introduction and purpose Childhood obesity is a major global health concern. The World Health Organization reports that the prevalence of obesity in children and adolescents has increased significantly from 4% in 1975 to over 18% in 2016. The aim of the study is to conduct a comprehensive review of the literature on obesity among children and adolescents, emphasizes the importance of prevention, identification and effective management of childhood obesity. Materials and methods An extensive examination of articles published in scientific journals was carried out through online research platforms PubMed and Google Scholar. We searched articles by entering keywords in appropriate configuration: “childhood obesity”, “pediatric overweight”, “physical activity”, “activity and health”, “diet and obesity", "bariatric surgery" and "obesity medication". State of knowledge Treating childhood obesity requires following a personalized weight loss program, as well as adopting healthy eating habits and lifestyle practices. Improvements in metabolic and anthropometric indices can be achieved through complex interventions including dietary modification and physical activity, behavioral therapy, health promotion education, pharmacological treatment and bariatric surgery A step-by-step approach to managing weight is recommended, considering the child's age, the severity of obesity, and any accompanying health conditions. Dietary interventions focus on promoting a balanced, nutrient-rich diet that is calorie-appropriate for the child's age and gender. Summary Further research is still necessary to develop additional pharmaceutical options, refine surgical techniques, and better understand long-term outcomes in this patient population.To effectively prevent this disease, a comprehensive approach is necessary, considering both education and changes in the social environment.

An Evidence-Based Nurse-Led Intervention to Reduce Diabetes Distress Among Adults With Type 1 Diabetes and Diabetes Distress (REDUCE): Development of a Complex Intervention Using Qualitative Methods Informed by the Medical Research Council Framework.

Diabetes distress refers to the negative emotional reaction to living with the demands of diabetes; it occurs in >40% of adults with type 1 diabetes (T1D). However, no interventions to reduce diabetes distress are specifically designed to be an integral part of diabetes care. This study aims to modify and adapt existing evidence-based methods into a nurse-led group intervention to reduce diabetes distress among adults with T1D and moderate to severe diabetes distress. The overall framework of this study was informed by the initial phase of the Medical Research Council's complex intervention framework that focused on undertaking intervention identification and development to guide the adaptation of the intervention. This study took place at 2 specialized diabetes centers in Denmark from November 2019 to June 2021. A total of 36 adults with T1D participated in 10 parallel workshops. A total of 12 diabetes-specialized nurses were interviewed and participated in 1 cocreation workshop; 12 multidisciplinary specialists, including psychologists, educational specialists, and researchers, participated in 4 cocreation workshops and 14 feedback meetings. Data were analyzed by applying a deductive analytic approach. The intervention included 5 biweekly 2.5-hour small group sessions involving adults with T1D and diabetes distress. Guided by a detailed step-by-step manual, the intervention was delivered by 2 trained diabetes specialist nurses. The intervention material included visual conversation tools covering seven diabetes-specific sources derived from the 28-item Type 1 Diabetes Distress Scale for measuring diabetes distress: (1) powerlessness, (2) self-management, (3) fear of hypoglycemia, (4) food and eating, (5) friends and family, (6) negative social perception, and (7) physician distress. The tools are designed to kick-start awareness and sharing of diabetes-specific challenges and strengths, individual reflections, as well as plenary and peer-to-peer discussions about strategies to manage diabetes distress, providing new perspectives on diabetes worries and strategies to overcome negative emotions. Diabetes specialist nurses expressed a need for a manual with descriptions of methods and detailed guidelines for using the tools. To deliver the intervention, nurses need increased knowledge about diabetes distress, how to support diabetes distress reduction, and training and supervision to improve skills. This co-design study describes the adaptation of a complex intervention with a strong evidence base, including detailed reporting of the theoretical underpinnings and core mechanisms.

Exploring Implementation Processes of a Multicomponent Family Support Intervention in Intensive Care Units (FICUS) Study: A Mixed-Methods Process Evaluation.

To investigate the experience with and progress of the implementation of a Family Support Intervention (FSI) into adult intensive care units (ICUs) as part of the cluster-randomised FICUS trial. A mixed-methods process evaluation using a multiple case study approach guided by the normalisation process theory. This study took place between June 2022 and July 2023 in eight Swiss ICUs randomised to the intervention arm. A tailored implementation strategy was used to introduce the multicomponent FSI, consisting of a new family nursing role and a family care pathway, into interprofessional ICU teams. Participants were 40 ICU key clinical partners. Qualitative data were collected twice, early (3-6 months) and mid-implementation (9-12 months), using small group interviews. A questionnaire with psychometric measures (Acceptability of Intervention Measure, Feasibility of Intervention Measure, Intervention Appropriateness Measure, Normalisation Measure Development Questionnaire) was administered at mid-implementation. RITA pragmatic rapid thematic analysis and descriptive statistics were used to analyse the data. Qualitative and quantitative results were then compared across ICUs (cases). Findings indicated the desired progress of the FSI integration overall and across cases, with high acceptability and appropriateness ratings but only moderate to high feasibility scores. Study-related barriers were noted in all ICUs (i.e., FSI delivery as part of a clinical trial). Implementation barriers included family nurses' limited capacity and clinician's attitudes towards the FSI. Leadership support and interprofessional collaboration were identified as facilitators. Case-based, integrated findings yielded two implementation pathways, namely early and protracted adopters. Implementation barriers were related to the feasibility of FSI delivery within the study context that required a high degree of standardisation and protocol adherence. Implementation progress was shaped by an interprofessional culture of family care, sufficient staff and time resources, and leadership support. The study's findings will inform future implementation of complex health interventions in ICUs. Good reporting of a Mixed-Methods Study (GRAMMS). Within the FICUS trial, a patient and family advisory board with a patient expert, three family members and a patient with own lived experience of critical care collaborate with the research team.

Feasibility of a complex psychosocial intervention for families with parental cancer: acceptability, suitability, implementability, and perceived support

PurposeThis study aimed to assess the feasibility of a comprehensive psychosocial intervention for families coping with parental cancer.MethodsA quasi-experimental trial with intervention and control group, employing a mixed-methods approach, was conducted. A total of 472 families affected by parental cancer participated. The feasibility of the intervention was evaluated based on study monitoring measures (on-site visits, team supervision meeting observations, case conference observations, best practice workshops, coordinating information exchange between intervention sites, and reviewing intervention documentation), process evaluation (semi-structured interviews, focus group discussion) and survey data. Data analysis involved thematic coding and descriptive statistics.ResultsThe intervention was well-received by the participating families, with a high degree of acceptance observed. The feasibility of the intervention was found to be associated with specific dynamics within each family system and the motivation of the family members. The success of the intervention was described as dependent on the family-centered arrangement of the encounters, including factors such as frequency, duration, and mode, which greatly influenced its overall acceptability.ConclusionThe family-scout intervention demonstrates its feasibility as an effective intervention to reduce the burden experienced by families coping with parental cancer. Psychosocial oncology services should continue to develop and implement family-centered interventions to offer support to families during their cancer journey.Trial registrationClinicalTrials.gov, NCT04186923. Retrospectively registered on 4 December 2019.

Development of a toolkit to help parents/caregivers manage feeding problems in autistic children: A protocol for a realist synthesis and toolkit co-design.

Many autistic children have feeding problems, typically eating a limited range of foods. Feeding problems affect quality of life, health, and development. Research suggests that parents are often unsure when to or whether to seek help. When they do, local provision of help across the UK is often lacking. A toolkit could offer a tailored, accessible, and scalable early intervention to support parents. We aim to develop the blueprint of a toolkit to help parents/caregivers manage feeding problems in their autistic children. Medical Research Council guidance on developing complex interventions informs three successive work packages: Realist review: a literature search and analysis using realist theory of logic to construct programme theory(s) in line with RAMESES (Realist And Meta-narrative Evidence Syntheses: Evolving Standards) guidance.Realist evaluation: interviews of three groups: autistic children, young people and adults (experts), parents/caregivers of autistic children (parents), and professionals who help parents manage feeding problems (professionals) across the UK. Analysis of verbatim interview transcripts using realist theory of logic to refine programme theory(s).Co-design of the toolkit blueprint: behaviour change theory applied to the programme theory(s) will generate candidate components for the online tool. A blueprint (a detailed textual outline) will be co-designed. A participatory research team of experts, parents, and professionals will be involved in each work package. Where consensus is needed it will be reached by asynchronous nominal group technique. A PPI (public and patient involvement) advisory group of experts and parents will ensure the project is relevant, respectful, and accessible. Findings of each step will be disseminated via journal publications, conferences, social media, as well as PPI-co-produced webinars and a dissemination event. On completion, this project will provide the foundation for the subsequent development and refinement of the prototype toolkit.

What is the carbon footprint of academic clinical trials? A study of hotspots in 10 trials

BackgroundClinical trials are fundamental to healthcare, however, they also contribute to anthropogenic climate change. Following previous work to develop and test a method and guidance to calculate the carbon footprint...

What is health services research?

In health services research, the health care of the population is examined under everyday conditions. Scientific questions include medical, patient-oriented, system-, performance- and quality-related as well as health economics topics. In health services research, complex interventions, e.g., treatment concepts with multiple therapy components, and/or across multiple sectors, are often implemented. The design of studies in health services research is based on the research question, the setting, and the available data, which can come from avariety of sources.

Application of the Medical Research Council guidance for complex interventions in the development of VIeSA, an intervention to support healthy ageing among community-dwelling older adults

BackgroundThe ageing population, coupled with the desire to age-in-place, highlight the need for programs that target health promotion as a means of maintaining functional ability, autonomy, and independence among community-dwelling older adults. This paper describes the development of the VIeSA intervention, which aimed to model a healthy ageing trajectory, including the identification of the necessary tools and methods, that would allow people older people, in partnership with health and social care professionals, to define personal health-related goals and the actions to achieve them. A key element of the intervention development was the creation of a support tool intended to assist this process.MethodsThe UK Medical Research Council (MRC) guidance on developing and evaluating complex interventions was applied in the development of the intervention and of the support tool. A participatory approach was selected, with stakeholders engaged on different occasions to allow the refinement of the intervention and of the support tool. Following the steps and suggested actions in the MRC development phase, the development process was conducted by identifying (1) the evidence base and (2) the theoretical framework and (3) by modelling the process and outcomes of the intervention.ResultsFollowing a literature review on effective interventions for functional ability, draft 1 of the support tool was designed. Focus groups with stakeholders provided feedback on this draft allowing for its refinement in terms of content, language use, and structure (draft 2). A review of the approaches for health promotion delivery led to further additions to the tool (draft 3) and informed the content of the training of health and social care professionals. After their training, professionals provided feedback on the acceptability, appropriateness, and feasibility of different elements of the intervention. Results suggested that no further major refinement to the intervention or support tool was necessary.ConclusionsThe design and development of the VIeSA intervention using the MRC guidance allowed for a clarity of direction, an optimised content in terms of usefulness and accessibility for all concerned stakeholders, and greater opportunities for its implementation and uptake.

Prevention Lab: a predictive model for estimating the impact of prevention interventions in a simulated Italian cohort

BackgroundA large fraction of the disease burden in the Italian population is due to behavioral risk factors. The objective of this work is to provide a tool to estimate the impact of preventive interventions that reduce the exposure to smoking and sedentary lifestyle of the Italian population, with the goal of selecting optimal interventions.MethodsWe construct a Markovian model that simulates the state of each subject of the Italian population. The model predicts the distribution of subjects in each health status and risk factor status for every year of the simulation. Based on this distribution, the model provides a rich output summary, such as the number of incident and prevalent cases for each tracing disease and the Disability Adjusted Life Years (DALY), used to assess the impact of preventive interventions, and how this impact is shaped in time.ResultsThis paper focuses on the methodological aspects of the model. The proposed model is flexible and can be applied to estimate the impact of complex interventions on the two risk factors and adapted to consider different cohorts. We validate the model by simulating the evolution of the Italian population from 2009 to 2017 and comparing the output with historical data. Furthermore, as a case-study, we simulate a counterfactual scenario where both tobacco and sedentary lifestyle are eradicated from the Italian population in 2019 and estimate the impact of such intervention over the following 20 years.ConclusionsWe propose a Markovian model to estimate how interventions on smoking and sedentary lifestyle can affect the reduction of the disease burden, and validate the model on historical data. The model is flexible and allows to extend the analysis to consider more risk factors in future research. However, we are aware that, given the ever-increasing availability of data, it is necessary in the future to increase the complexity of the model, to be closer to reality and to provide decision-making support to the policy-makers.

A complex ePrescribing antimicrobial stewardship-based (ePAMS+) intervention for hospitals: mixed-methods feasibility trial results

BackgroundAntibiotic resistant infections cause over 700,000 deaths worldwide annually. As antimicrobial stewardship (AMS) helps minimise the emergence of antibiotic resistance resulting from inappropriate use of antibiotics in healthcare, we developed ePAMS+ (ePrescribing-based Anti-Microbial Stewardship), an ePrescribing and Medicines Administration (EPMA) system decision-support tool complemented by educational, behavioural and organisational elements.MethodsWe conducted a non-randomised before-and-after feasibility trial, implementing ePAMS+ in two English hospitals using the Cerner Millennium EPMA system. Wards of several specialties were included. Patient participants were blinded to whether ePAMS+ was in use; prescribers were not. A mixed-methods evaluation aimed to establish: acceptability and usability of ePAMS+ and trial processes; feasibility of ePAMS+ implementation and quantitative outcome recording; and a Fidelity Index measuring the extent to which ePAMS+ was delivered as intended. Longitudinal semi-structured interviews of doctors, nurses and pharmacists, alongside non-participant observations, gathered qualitative data; we extracted quantitative prescribing data from the EPMA system. Normal linear modelling of the defined daily dose (DDD) of antibiotic per admission quantified its variability, to inform sample size calculations for a future trial of ePAMS+ effectiveness.ResultsThe research took place during the SARS-CoV-2 pandemic, from April 2021 to November 2022. 60 qualitative interviews were conducted (33 before ePAMS+ implementation, 27 after). 1,958 admissions (1,358 before ePAMS+ implementation; 600 after) included 24,884 antibiotic orders.Qualitative interviews confirmed that some aspects of ePAMS+ , its implementation and training were acceptable, while other features (e.g. enabling combinations of antibiotics to be prescribed) required further development. ePAMS+ uptake was low (28 antibiotic review records from 600 admissions; 0.047 records per admission), preventing full development of a Fidelity Index. Normal linear modelling of antibiotic DDD per admission showed a residual variance of 1.086 (log-transformed scale). Unavailability of indication data prevented measurement of some outcomes (e.g. number of antibiotic courses per indication).ConclusionsThis feasibility trial encountered unforeseen circumstances due to contextual factors and a global pandemic, highlighting the need for careful adaptation of complex intervention implementations to the local setting. We identified key refinements to ePAMS+ to support its wider adoption in clinical practice, requiring further piloting before a confirmatory effectiveness trial.Trial registrationISRCTN Registry ISRCTN13429325, 24 March 2022.

Perineal massage and warm compresses–Implementation study of a complex intervention in health

ObjectivesTo determine the effect of using tailored and multifaceted strategies on the acceptability, appropriateness, feasibility and adoption of a perineal massage and warm compress intervention by midwives in a maternity ward of a tertiary hospital in Portugal. MethodsThe complex intervention in health was developed based on the Medical Research Council framework and guided by the Theory of Change. Tailored and multifaceted strategies, including dissemination, integration and implementing process strategies, were applied. A mixed-methods approach was adopted, with a combination of qualitative (semi-open interviews) and quantitative (surveys, audits and electronic health records) methods. Surveys were applied to assess the acceptability, appropriateness and feasibility of the intervention. In order to evaluate adoption of the intervention, data from interviews were introduced into NVivo Version 10 to perform thematic analysis, and each audit checklist criterion was analysed using McNemar's exact test to determine differences in paired proportion. ResultsThis study found high acceptability (mean±standard deviation 4.28±0.45), high appropriateness (4.32±0.47) and high feasibility (4.26±0.43) of the intervention by midwives. Differences were reported for most topics between interviews conducted before and after implementation of the intervention. Pre-intervention, the midwives reported that the main factor affecting the application of perineal protection techniques was the lack of continuous presence of the midwife. The birth position was the alternative birth position (hands and knees, side-lying, squatting and semi-sitting), avoiding the lithotomy position. Techniques used for perineal protection were warm compresses, hands-on techniques, hands-off techniques and spontaneous pushing; and the reasons given for performing an episiotomy were large (high-birthweight) baby, Kristeller manoeuvre, tense perineum and previous obstetric sphincter injury. Post-intervention, the midwives reported that the presence of a second person increases the safety of professionals and women and improves working relations. The technique used for perineal protection was autonomy to adapt the intervention with perineal massage and warm compresses. A comfortable birth position for woman was used, and the rate of episiotomy reduced (only performed in the case of fetal distress). Regarding audits, significant differences (p < 0.05) were found for all audit criteria (pre- and post-intervention), which means that midwives adopted the intervention into their clinical practice. ConclusionAcceptability, appropriateness, feasibility and adoption of the intervention by midwives were high. Thus, tailored and multifaceted strategies were effective to achieve the implementation outcomes.

The ABCs of mental health at the university: a multi-level intervention design for promoting mental well-being.

There is an escalating concern for the mental health of university students being recognized as a high-risk group for psychological distress. Despite research emphasizing the need to integrate mental well-being into higher education, existing interventions primarily focus on challenges and support services, leaving a gap in practical insights for promoting mental well-being at the university as a whole. This paper aims to cover the theoretical and methodological foundations for the design and development of a complex multi-level intervention called the ABCs of mental health at the university (ABC-uni). Following the MRC framework for complex interventions, the design and development of a novel complex intervention is described (Phase I). Using the socio-ecological model and incorporating principles from health promotion charters, capacity building, organizational change models, and the principles of the ABCs of mental health a program theory for mental health promotion at the university is proposed. Following this theoretical foundation a logic model outlines the ABC-uni intervention components at structural, community, and individual levels. The components include staff training, campaign materials, a photovoice project, integration of mental well-being literacy into introductory programs, a credit-bearing course, and an online module. Preferably, most of these components are developed and carried out collaboratively with students at the university. As proposed in the logic model expected outcomes encompass heightened awareness, supportive environments, commitment, and accountability, aiming to enhance mental well-being across the entire university. The design and development of the intervention components occur at a Danish public university. This section addresses the strengths and limitations of the design of the ABC-uni intervention. Future research will cover the feasibility phase of each components of the ABC-uni intervention (phase II). The conceptual framework and program theory outlining mental health promotion at the university, along with the detailed description of the intervention components, provides valuable insights for fostering mental well-being in the university community.

A Complex Meta-Regression Model to Identify Effective Features of Interventions From Multi-Arm, Multi-Follow-Up Trials.

Network meta-analysis (NMA) combines evidence from multiple trials to compare the effectiveness of a set of interventions. In many areas of research, interventions are often complex, made up of multiple components or features. This makes it difficult to define a common set of interventions on which to perform the analysis. One approach to this problem is component network meta-analysis (CNMA) which uses a meta-regression framework to define each intervention as a subset of components whose individual effects combine additively. In this article, we are motivated by a systematic review of complex interventions to prevent obesity in children. Due to considerable heterogeneity across the trials, these interventions cannot be expressed as a subset of components but instead are coded against a framework of characteristic features. To analyse these data, we develop a bespoke CNMA-inspired model that allows us to identify the most important features of interventions. We define a meta-regression model with covariates on three levels: intervention, study, and follow-up time, as well as flexible interaction terms. By specifying different regression structures for trials with and without a control arm, we relax the assumption from previous CNMA models that a control arm is the absence of intervention components. Furthermore, we derive a correlation structure that accounts for trials with multiple intervention arms and multiple follow-up times. Although, our model was developed for the specifics of the obesity data set, it has wider applicability to any set of complex interventions that can be coded according to a set of shared features.

Using contribution analysis to assess evaluation capacity outcomes in community organizations

AbstractCommunity organizations face challenges in addressing the needs of their members and beneficiaries, particularly during times of crisis. More than ever, evidence‐informed programming and decision‐making are essential to help organizations “do more with less”; however, community organizations seldom have the individual and organizational evaluation capacity required to conduct and use evaluations to inform decision‐making. This article provides an overview of the evaluation of the LaboEval evaluation capacity building (ECB) intervention, a 5‐year program implemented in 16 organizations. LaboEval brings together direct and indirect individual and organizational ECB activities to enhance evaluation capacity. Contribution analysis (CA) was used as the evaluation approach in this study, assessing the intervention's activities, outputs, outcomes, and assumptions. Data sources include interviews, document reviews, surveys, administrative data, and a literature review. This evaluation contributes to the field by applying CA to a multiyear, multi‐organizational ECB intervention. The findings inform evaluation capacity builders and evaluators interested in CA, showcasing a unique approach to evaluating complex interventions across multiple organizations.

Working in partnership to reduce re-offending and improve prison leavers’ lives: a process evaluation of a prison leaver pilot project

Prison leavers encounter significant barriers to successfully re-integrating into the community, which can lead to re-offending. Complex interventions which are multi-faceted and involve successful partnerships are needed to meet the distinct health and social needs of this population group. For this study, we conducted a process evaluation of a pilot project, which aimed to offer holistic support to prison leavers through a combination of peer mentoring, sport and physical activity, and signposting, delivered in a community setting. Semi-structured interviews and focus groups were conducted with individuals (n = 14) involved in the delivery and the management of the project to understand how it had been implemented and what factors had influenced the delivery and partnerships involved. Factors that influenced project delivery included safeguarding and risk assessment concerns, lived experience of peer mentors, accessibility of the intervention, and the role of sport and physical activity as a vehicle for community re-integration. Partnership working was influenced by effective information sharing, organizational commitment, building relationships and professional networks, and regular communication between organizations. An intervention involving peer mentoring, sport and physical activity, and signposting, supported by close partnership working, was viewed as a promising approach to support the community re-integration of prison leavers.

Stretchable wireless optoelectronic synergistic patches for effective wound healing

Physiotherapies play a crucial role in noninvasive tissue engineering for wound healing. However, challenges such as the implementation of complex interventions and unsatisfactory treatment outcomes impede widespread application. Here, we proposed a stretchable and wirelessly-powered optoelectronic synergistic patch with a dual-layer serpentine wireless receiver circuit to drive the optoelectronic modulation component. Optimized structure and impedance matching enable the patch to seamlessly attach to irregular skin surfaces and operate robustly over a 30% tensile strain range. Based on Sprague-Dawley rat wound model. The wound closure rate of the optoelectronic synergistic group significantly outperformed both monointervention and blank control groups. Mechanistically, optoelectronic synergistic intervention enhances the secretion of vascular endothelial marker proteins and growth factors, and stabilizes mitochondrial function during oxidative stress. Overall, the scalable amalgamation of flexible electronics, wireless transmission, and synergistic interventions promise to improve wound care.

Perceptions and Experiences of Animal-Assisted Interventions for People Living With Dementia: A Qualitative Evidence Synthesis.

To synthesise stakeholders' experiences and perceptions of animal-assisted intervention (AAI) for people with dementia in community care settings. Qualitative evidence synthesis. We systematically searched Medline, CINAHL, Embase, Scopus, Web of Science, PsycINFO and AgeLine for potentially eligible studies. Thematic synthesis was used to analyse the data from included studies. We assessed the methodological limitations of included studies using an adaptation of the Critical Appraisal Skills Programme checklist and used Confidence in the Evidence from Reviews of Qualitative Research (GRADE-CERQual) tool to assess confidence in review findings. This review is reported using the ENTREQ checklist. We included 14 reports from 11 studies and developed three analytical themes incorporating a gardening analogy: planting-connecting with animals, growing-engaging in AAI and nurturing-making AAI work; and six subthemes: willingness to connect, building relationships, a rich experience, the benefits of AAI, individualised and holistic approach and training and support, with 15 key findings. This review describes people's experiences and perceptions of AAI for people with dementia, and provides recommendations on the development and implementation of AAI, with moderate to high confidence. Nurses need to consider the factors that influence the implementation of AAI identified in this review, to facilitate engagement and long-term impacts while adopting AAI in community care settings. This review may enhance healthcare professionals' understanding of AAI for people with dementia in community care settings. AAI is a complex intervention that can be delivered in varied manner. A multicomponent, flexible and individualised AAI is important. Additional training and education for staff are needed. A man with dementia and his wife who share a love of dogs, advised at each step of the review, providing insights and perspectives and contributing as co-authors.