Medical Research Council Guidelines Research Articles

The responsiveness and clinical utility of the Australian therapy outcome measure for indigenous clients.

The Australian Therapy Outcome Measure for Indigenous Clients (ATOMIC) is a goal-setting tool designed to measure therapy outcomes with First Australians. It was originally developed and validated for use with First Australian children as a culturally responsive alternative to traditional western outcome measures. This research explored the applicability, responsiveness and clinical utility of the ATOMIC when used with First Australian adults attending an urban health service. Separate parallel studies investigated responsiveness and clinical utility. The first employed quantitative methods to investigate change over time via pre- and post-intervention data. The second employed a qualitative phenomenological approach to determine the clinical utility of the tool. Semi-structured interviews and focus groups were used, respectively, to understand the experience of using the ATOMIC from a client and clinician perspective. Client perspectives on the purpose of the tool and its alignment with their views on health care and therapists' perspective on the ease of use and applicability of the tool to the health service setting were explored. These data were analysed using reflexive thematic analysis. The methodological approach followed National Health and Medical Research Council (NHMRC, 2018) guidelines in considering cultural continuity, reciprocity and equity. This project was initiated and guided by Aboriginal and Torres Strait Islander leaders (the advisory group) as a prioritised need for a robust way of reporting outcomes to complement existing statistical and narrative data within a large community-controlled health service. The advisory group provided high level governance from project conception to conclusion and were involved in yarn-backs about research findings. Responsiveness: Wilcoxon test showed a statistically significant increase (P = 0.00) in ATOMIC scores pre- (mean = 1.8) and post- (mean = 8) intervention. Effect size (Cohen d) was deemed significant calculated at 2.1. Findings included: First Australian clients are adept at self-managing their conditions; the ATOMIC is a clinically useful outcome measure, which reflects this; ATOMIC is an acceptable tool to First Australian clients and clinicians and supports culturally responsive goal setting and occupational therapy practice. The Australian Therapy Outcome Measure for Indigenous Clients (ATOMIC) was created to measure how well therapy works for First Australian children. This research investigates whether it also works with adult First Australians. Two studies were undertaken: a quantitative study to see whether ATOMIC scores changed before and after therapy and a qualitative study, which asked people what they thought about using the ATOMIC. ATOMIC scores went up after therapy, indicating it is sensitive to change, and both clients and therapists liked using the ATOMIC and found it useful. It matched well with how First Australian adults see health care and helped set goals for therapy. The results of the study show that the ATOMIC is helpful for both clients and therapists in understanding how well therapy works and helps to set goals that make sense culturally. This study looked at one health service in one regional area, so more research is needed to establish whether it works elsewhere. Overall, the results indicate the ATOMIC is a promising step towards better therapy for Indigenous Australians.

Development and implementation of a physiotherapy exercise intervention with tailored support for exercise adherence for people with vertebral fragility fractures (OPTIN trial)

ObjectivesThe OsteoPorosis Tailored exercise adherence INtervention (OPTIN) trial is a two-arm, multi-centre randomised controlled trial. It compares the effectiveness of physiotherapy exercise rehabilitation with integrated support for exercise adherence, to physiotherapy exercise rehabilitation alone, for people with vertebral fragility fracture (VFF) and back pain. This paper describes the development of the physiotherapist-led adherence enhanced intervention. MethodsWe used an intervention mapping approach and followed Medical Research Council guidelines for developing complex interventions. We co-created the intervention involving expert clinicians, service managers, researchers, and adults with long-term musculoskeletal conditions, including osteoporosis. We identified a theoretical framework, reviewed the evidence, used a feasibility study, and considered clinical practice and deliverability within UK National Health Service (NHS) outpatient physiotherapy secondary care. Through a collaborative workshop, we refined the intervention, involved patients again and re-tested the intervention. Finally, we manualised the intervention, produced patient and physiotherapist materials and trained physiotherapists for delivery. ResultsThe OPTIN intervention uses a motivational interviewing approach and captures information about patient goals, barriers, and facilitators to exercise. Physiotherapists assess exercise capability, opportunities and motivation and utilise at least three behaviour change approaches, selecting from an intervention toolkit of nine approaches to support exercise behaviour. Ninety minutes of additional physiotherapy are provided to deliver the intervention, integrated within the assessment and six follow-up visits. ConclusionsA theory-informed intervention to support exercise adherence was developed and delivered by physiotherapists trained in the intervention to older adults with VFF and back pain in the intervention arm (n = 63) of the OPTIN trial. Trial Registration numberISRCTN 14465704. Contribution of Paper•Describes the development of an intervention to support adherence to physiotherapy exercise for people with vertebral fragility fracture.•Reports in detail the intervention for replication.

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

BackgroundComprehensive sexuality education (CSE) is critical in addressing negative sexual and reproductive health (SRH) outcomes among adolescents. Yet in many low- and middle-income countries (LMICs) including Zambia, little is known about the impact, realities of CSE implementation, the quality of teaching and the comprehensiveness of the content covered.MethodsOur approach was informed by a process evaluation incorporating recommendations by the European Expert Group guidance on evaluating sexuality education programmes and the Medical Research Council (MRC) guidelines on process evaluation. The development process and quality of CSE implementation were assessed using eight and six quality criteria respectively. In-depth interviews (IDIs), focus group discussions (FGDs), document analysis and classroom observation were employed to assess contextual factors, implementation process and mechanisms of impact of CSE. In-depth interviews (50) and focus group discussions (2) with seven pupils in each group were conducted among 64 purposefully selected participants. The sample comprised pupils (35), parents (4) and teachers (17) from nine secondary schools (four peri-urban, four urban and one rural), policymakers (4), and religious leaders (4). We employed deductive content analysis to analyse the data.ResultsContextual factors that influenced the implementation of CSE included: (1) piecemeal funding for the CSE programme; (2) lack of monitoring programmes in schools; (3) lack of community engagement; (4) religious and socio-cultural barriers; (5) lack of skills and competency to teach CSE; and (6) insufficient time allocation for CSE. The assessment of the quality of the development of CSE revealed: (1) a lack of sexual diversity; (2) no meaningful participation of pupils in programme implementation; (3) a lack of stakeholder engagement during programme implementation; (4) lack of gender sensitivity; and (5) lack of human rights approach. Assessment of the quality of the implementation of CSE revealed: (1) no evidence of skill-based CSE teaching; (2) no linkage between CSE and SRH services in the communities; and (3) a lack of incorporation of multiple delivery methods during CSE teaching. The mechanisms of impact of CSE were related to the acceptability and positive changes in pupils’ SRH practices.ConclusionThe complex influences of contextual factors during CSE implementation highlight the need for contextual analysis during the interventional design. Co-creation of the CSE programme through stakeholder participation could reduce social opposition and enable a culturally sensitive CSE. Comprehensive teacher training, a guiding curriculum as well as setting of appropriate monitoring tools and indicators are likely to enhance the quality of CSE implementation.

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

BackgroundPOINCARE-2 trial aimed to assess the effectiveness of a strategy designed to tackle fluid overload through daily weighing and subsequent administration of treatments in critically ill patients. Even in highly standardized care settings, such as intensive care units, effectiveness of such a complex intervention depends on its actual efficacy but also on the extent of its implementation. Using a process evaluation, we aimed to provide understanding of the implementation, context, and mechanisms of change of POINCARE-2 strategy during the trial, to gain insight on its effectiveness and inform the decision regarding the dissemination of the intervention.MethodsWe conducted a mixed-method process evaluation following the Medical Research Council guideline. Both quantitative data derived from the trial, and qualitative data from semi-structured interviews with professionals were used to explain implementation, mechanisms of change of the POINCARE-2 strategy, as well as contextual factors potentially influencing implementation of the strategy.ResultsScore of actual exposure to the strategy ranged from 29.1 to 68.2% during the control period, and from 61.9 to 92.3% during the intervention period, suggesting both potential contamination and suboptimal fidelity to the strategy. Lack of appropriate weighing devices, lack of human resources dedicated to research, pre-trial rooted prescription habits, and anticipated knowledge of the strategy have been identified as the main barriers to optimal implementation of the strategy in the trial context.ConclusionsBoth contamination and suboptimal fidelity to POINCARE-2 strategy raised concerns about a potential bias towards the null of intention-to-treat (ITT) analyses. However, optimal fidelity seemed reachable. Consequently, a clinical strategy should not be rejected solely on the basis of the negativity of ITT analyses’ results. Our findings showed that, even in highly standardized care conditions, the implementation of clinical strategies may be hindered by numerous contextual factors, which demonstrates the critical importance of assessing the viability of an intervention, prior to any evaluation of its effectiveness.Trial registrationNumber NCT02765009

A mixed methods process evaluation: understanding the implementation and delivery of HIV prevention services integrated within sexual reproductive health (SRH) with or without peer support amongst adolescents and young adults in rural KwaZulu-Natal, South Africa

BackgroundCombination prevention interventions, when integrated with community-based support, have been shown to be particularly beneficial to adolescent and young peoples’ sexual and reproductive health. Between 2020 and 2022, the Africa Health Research Institute in rural South Africa conducted a 2 × 2 randomised factorial trial among young people aged 16–29 years old (Isisekelo Sempilo) to evaluate whether integrated HIV and sexual and reproductive health (HIV/SRH) with or without peer support will optimise delivery of HIV prevention and care. Using mixed methods, we conducted a process evaluation to provide insights to and describe the implementation of a community-based peer-led HIV care and prevention intervention targeting adolescents and young people.MethodsThe process evaluation was conducted in accordance with the Medical Research Council guidelines using quantitative and qualitative approaches. Self-completed surveys and clinic and programmatic data were used to quantify the uptake of each component of the intervention and to understand intervention fidelity and reach. In-depth individual interviews were used to understand intervention experiences. Baseline sociodemographic factors were summarised for each trial arm, and proportions of participants who accepted and actively engaged in various components of the intervention as well as those who successfully linked to care were calculated. Qualitative data were thematically analysed.ResultsThe intervention was feasible and acceptable to young people and intervention implementing teams. In particular, the STI testing and SRH components of the intervention were popular. The main challenges with the peer support implementation were due to fidelity, mainly because of the COVID-19 pandemic. The study found that it was important to incorporate familial support into interventions for young people’s sexual health. Moreover, it was found that psychological and social support was an essential component to combination HIV prevention packages for young people.ConclusionThe results demonstrated that peer-led community-based care that integrates SRH services with HIV is a versatile model to decentralise health and social care. The family could be a platform to target restrictive gender and sexual norms, by challenging not only attitudes and behaviours related to gender among young people but also the gendered structures that surround them.

P-498 Multicentre two-arm randomised controlled trial of Beyond Fertility: A brief face-to-face psychosocial intervention to promote patients’ healthy adjustment when ending unsuccessful fertility treatment

Abstract Study question Is Beyond Fertility effective in ameliorating the negative impact of ending unsuccessful fertility treatment (EoT) on patients’ quality of life? Summary answer Patients allocated to Beyond Fertility (intervention group) reported higher quality of life six months after EoT than patients allocated to care as usual (control group). What is known already Around four in every ten patients end all IVF/ICSI treatment cycles without achieving a live birth (referred as EoT). Recent mixed-methods research indicates 93.3% of patients want to be prepared for and supported through EoT. Two interventions have been proven to improve the wellbeing of people with an unfulfilled wish for children after they proactively started trying to conceive, but, to our knowledge, no intervention focused on preparing and supporting fertility patients through this experience. Following the Medical Research Council guidelines, we developed Beyond Fertility, a face-to-face psychosocial intervention integrating preventive with early-interventive care to ease patients’ adjustment during EoT. Study design, size, duration Multicentre two-arm parallel-group open-label RCT with 1:1 allocation to intervention (Beyond Fertility) or control (usual mental-healthcare at participating clinics, CaU). Beyond Fertility includes seven therapeutic sessions: one (individual/couple) within one month the last IVF/ICSI cycle (preventive care) and six (individual/couple and group) sessions after EoT (early-interventive care). Participants self-reported on quality-of-life one month before their last reimbursed IVF/ICSI cycle (T1, pre-session 1), two weeks (T2, post-session 1) and six months (T4, post-intervention) after cycle ended. Participants/materials, setting, methods Women patients were consecutively screened and invited to participate with their partners at four public fertility centres in Portugal (Dez 2021-Mar 2023). Inclusion criteria were being adults scheduled to initiate their last reimbursed IVF/ICSI cycle within one month. Primary outcome was quality-of-life, self-reported online with FertiQoL (Melo et al., 2012). Linear-mixed-effect models compared changes in quality-of-life from T1 to T2 and T4 in intervention and control groups. Outcome data were reported for modified intention-to-treat (mITT). Main results and the role of chance From 143 eligible women(90.51% eligibility rate), 74(51.75% consent rate) and 41 partners completed T1 assessment(N=115) and were allocated to Beyond Fertility(n=60) or CaU(n=55). Average age was 38 years. Sixty-four percent were women, 62% had university education, 92% were employed, all were in a heterosexual relationship, and 30% had children. Participants were undergoing treatment for around three years. Fourteen(14.14%) achieved a pregnancy in their last reimbursed IVF/ICSI cycle, 34(34.34%) did not achieve a pregnancy and ended treatment (i.e. faced EoT), and 51(51.52%) did not achieve a pregnancy and continued treatment. Among participants who were allocated to Beyond Fertility and faced EoT, eight(44.44%) withdrew from its early-interventive care mainly due to not accepting the group format, and only four(22.22%) received the full intervention due to practicality issues. Among participants who faced EoT, participation rates for Beyond Fertility and CaU groups were 88.89%(n=16) and 100%(n=16) at T2, and 77.78%(n=14) and 93.75%(n=15) at T4, respectively. Among these participants, those allocated to Beyond Fertility had an estimated mean quality-of-life score around 6 points higher than participants allocated to CaU at T2 (β=6.17, p=0.113) and around 9 points higher (almost one standard deviation above the baseline mean of the total sample) at T4 (β=8.95, p=0.035). Limitations, reasons for caution The trial was not blind, and therefore, response bias cannot be ignored. Attrition was slightly higher in the Beyond Fertility than the CaU group, suggesting that mITT may marginally overestimate the effect of Beyond Fertility. Wider implications of the findings Structured psychosocial care that starts during treatment and continues in its aftermath to support patients who end treatment without achieving pregnancy is effective in ameliorating declines in quality-of-life, suggesting it can ease adjustment during this difficult life transition. Benefits may be maximised by tailoring it to patients’ preferred delivery format. Trial registration number ISRCTN Registry ISRCTN85897617

Simulation-based team training for healthcare professionals in pediatric departments: study protocol for a nonrandomized controlled trial

BackgroundHealthcare systems worldwide face challenges related to patient safety, quality of care, and interprofessional collaboration. Simulation-based team training has emerged as a promising approach to address some of these challenges by providing healthcare professionals with a controlled and safe environment to enhance their teamwork and communication skills. The purpose of this study protocol is to describe an intervention using simulation-based team training in pediatric departments.MethodsUsing a parallel-group, non-randomized controlled trial design, a simulation-based team training intervention will be implemented across four pediatric departments in Denmark. Another four pediatric departments will serve as controls. The intervention implies that healthcare professionals engage in simulation-based team training at a higher quantity and frequency than they did previously. Development of the intervention occurred from April 2022 to April 2023. Implementation of the intervention occurs from April 2023 to April 2024. Evaluation of the intervention is planned from April 2024 to April 2025. All simulation activity both before and during the intervention will be registered, making it possible to compare outcomes across time periods (before versus after) and across groups (intervention versus control). To evaluate the effects of the intervention, we will conduct four analyses. Analysis 1 investigates if simulation-based team training is related to sick leave among healthcare professionals. Analysis 2 explores if the simulation intervention has an impact on patient safety culture. Analysis 3 examines if simulation-based team training is associated with the treatment of critically ill newborns. Finally, Analysis 4 conducts a cost-benefit analysis, highlighting the potential return on investment.DiscussionThe implemented simulation-based team training intervention can be defined as a complex intervention. Following the Medical Research Council framework and guidelines, the intervention in this project encompasses feasibility assessment, planning of intervention, implementation of intervention, and rigorous data analysis. Furthermore, the project emphasizes practical considerations such as stakeholder collaboration, facilitator training, and equipment management.Trial registrationRegistered as a clinical trial on clinicaltrials.gov, with the identifier NCT06064045.

Process evaluation of the CO-WORK-CARE model: Collaboration and a person-centred dialogue meeting for patients with common mental disorder in primary health care.

To ensure optimal patient care based on evidence, it is crucial to understand how to implement new methods in practice. However, intervention studies often overlook parts of the implementation process. A comprehensive process evaluation is necessary to understand why interventions succeed or fail in specific contexts and to integrate new knowledge into daily practice. This evaluation examines the full implementation of the Co-Work-Care model in Swedish primary healthcare to identify strengths and weaknesses. This study aimed to evaluate the process of implementing the CO-WORK-CARE model that focuses on close collaboration and the use of a person-centred dialogue meeting in primary healthcare for patients on sick leave due to common mental disorders. The CO-WORK-CARE model emphasises collaboration among the GP, rehabilitation coordinator and care manager, along with person-centred dialogue meetings involving employers. Following UK Medical Research Council guidelines, we conducted a process evaluation. Data from previous studies were reanalysed. We also analysed field notes and meeting notes using Malterud's qualitative method. The evaluation identified key facilitators for model implementation, including regular visits by facilitators and guidance from the research physician. Peer support meetings also bolstered implementation. However, challenges emerged due to conflicts with existing structures and limitations in person-centred dialogue meetings. Adapting the CO-WORK-CARE model to Swedish primary care is feasible and beneficial, with collaboration among the care manager, rehabilitation coordinator and GP and person-centred dialogue meetings. Thorough preparations, ongoing facilitator and peer support and integrated information enhanced implementation efficiency, despite challenges posed by existing structures.

P080 Supporting shared decision-making about osteoporosis medicines: Combining multiple methods to develop the prototype iFraP intervention

Abstract Background/Aims Shared decision-making (SDM) is a joint process in which a person and healthcare professional work together to reach decisions about care. The iFraP (Improving uptake of Fracture Prevention drug treatments) intervention comprises computerised decision aid (DA), Fracture Liaison Service (FLS) clinician training package, and information resources to support SDM about osteoporosis medicines. This abstract details our multi-method approach to develop this intervention. Methods Intervention development was underpinned by the Medical Research Council guidelines for development of complex interventions. Four studies guided intervention prototype development, including (1) an evidence synthesis of existing osteoporosis DAs to examine quality and effectiveness; (2) a review of patient information about osteoporosis to evaluate quality and optimal language for talking about osteoporosis; (3) a Delphi consensus survey with patients, carers, and health professionals to gain consensus on intervention content, informed by an evidence review of relevant clinical guidelines and behavioural theories; (4) and focus groups and interviews with patients recently attending FLS, FLS clinicians and general practitioners (GPs) to explore current FLS practice, and barriers and facilitators to change. Expert stakeholders and public contributors informed each sub-study. Results Studies one and two informed design of the iFraP computerised DA. Evidence reviews of existing osteoporosis DAs and patient information found that they did not meet patient needs and identified poor readability, variable quality, and unbalanced and confusing content. Public contributors preferred DAs which were individualised, and together with expert stakeholders, supported the development of understandable explanations of osteoporosis and osteoporosis medicines to include in iFraP resources. Study three identified essential components of the FLS consultation which directly informed DA content. Study four identified the need for complementary iFraP information resources, training, and potential barriers to iFraP DA use. Patients expressed that they did not feel adequately prepared for their FLS consultation, leading to the development of an enhanced leaflet to accompany their FLS appointment letter. Patients, FLS clinicians, and GPs all expressed the need for a patient-friendly individualised summary of the FLS consultation, to facilitate consistent information across services and reinforce FLS messaging. This finding informed development of the iFraP Bone Health Record, an individualised, easy-read PDF print-out of the iFraP DA. FLS clinicians identified training needs relating to communicating risk, involving patients in decisions and clinical decision-making. Barriers to use included concerns that the DA would increase consultation duration, and that SDM may undermine their goal to facilitate medicine adherence. Identified barriers to use and training needs informed the content and delivery of the interactive eLearning and role play session, with consideration of theoretically-informed behaviour change techniques. Conclusion The iFraP complex intervention development work demonstrates the use of multiple methods to develop an evidence-based and theoretically-driven intervention in-preparation for testing. Disclosure L. Bullock: None. J. Fleming: None. E.M. Clark: None. S. Leyland: None. S. Thomas: Grants/research support; ST owns Prescribing Decision Support Ltd that developed the iFraP decision aid. C. Gidlow: None. T.W. O'Neill: Grants/research support; TON is supported by the NIHR Manchester Biomedical Research Centre. C.P. Iglesias-Urrutia: None. A. Hawarden: Grants/research support; AH is funded by a Versus Arthritis Clinical Research Fellowship (reference 22726). F. Manning: None. J. Protheroe: None. J. Lefroy: None. S. Ryan: None. R. Horne: None. C.D. Mallen: Grants/research support; CM is funded by the NIHR Applied Research Collaboration West Midlands and the NIHR School for Primary Care Research. C. Jinks: Grants/research support; CJ is part funded by NIHR Applied Research Collaboration (ARC) West Midlands. Z. Paskins: Consultancies; ZP has received consultancy fees from UCB Pharma. Grants/research support; ZP is funded by the National Institute for Health Research (NIHR) [Clinician Scientist Award (CS-2018-18-ST2-010)/NIHR Academy].

A clinical consensus paper on jejunal tube feeding in children.

Feeding problems are common in children with complex medical problems or acute critical illness and enteral nutrition may be required. In certain situations, gastric tube feeding is poorly tolerated or may not be feasible. When feed intolerance persists despite appropriate adjustments to oral and gastric enteral regimens, jejunal tube feeding can be considered as an option for nutrition support. A multidisciplinary expert working group of the Australasian Society of Parenteral and Enteral Nutrition was convened. They identified topic questions and five key areas of jejunal tube feeding in children. Literatures searches were undertaken on Pubmed, Embase, and Medline for all relevant studies, between January 2000 and September 2022 (n = 103). Studies were assessed using National Health and Medical Research Council guidelines to generate statements, which were discussed as a group, followed by voting on statements using a modified Delphi process to determine consensus. A total of 24 consensus statements were created for five key areas: patient selection, type and selection of feeding tube, complications, clinical use of jejunal tubes, follow-up, and reassessment. Jejunal tube feeding is a safe and effective means of providing nutrition in a select group of pediatric patients with complex medical needs, who are unable to be fed by gastric tube feeding. Appropriate patient selection is important as complications associated with jejunal tube feeding are not uncommon, and although mostly minor, can be significant or require tube reinsertion. All children receiving jejunal tube feeding should have multidisciplinary team assessment and follow-up.

The development of a novel sexual health promotion intervention for young people with mental ill-health: the PROSPEct project

BackgroundYoung people with mental ill-health experience higher rates of high-risk sexual behaviour, have poorer sexual health outcomes, and lower satisfaction with their sexual wellbeing compared to their peers. Ensuring good sexual health in this cohort is a public health concern, but best practice intervention in the area remains under-researched. This study aimed to co-design a novel intervention to address the sexual health needs of young people with mental ill-health to test its effectiveness in a future trial undertaken in youth mental health services in Melbourne, Australia.MethodsWe followed the 2022 Medical Research Council (MRC) guidelines for developing and evaluating complex interventions. This involved synthesising evidence from the ‘top down’ (published evidence) and ‘bottom up’ (stakeholder views). We combined systematic review findings with data elicited from qualitative interviews and focus groups with young people, carers, and clinicians and identified critical cultural issues to inform the development of our intervention.ResultsExisting evidence in the field of sexual health in youth mental health was limited but suggested the need to address sexual wellbeing as a concept broader than an absence of negative health outcomes. The Information-Motivation-Belief (IMB) model was chosen as the theoretical Framework on which to base the intervention. Interviews/focus groups were conducted with 29 stakeholders (18 clinicians, three carers, and eight young people). Synthesis of the evidence gathered resulted in the co-design of a novel intervention consisting of an initial consultation and four 60-90-minute sessions delivered individually by a young ‘sex-positive’ clinician with additional training in sexual health. Barriers and supports to intervention success were also identified.ConclusionsUsing the MRC Framework has guided the co-design of a potentially promising intervention that addresses the sexual health needs of young people with mental ill-health. The next step is to test the intervention in a one-arm feasibility trial.

Process evaluation of a parent-child communication intervention for adolescent sexual and reproductive health in Uganda

BackgroundPrevious initiatives concerning adolescent sexual and reproductive health (SRH) education in Low-or-Middle Income Countries (LMICs) have been limited by cultural norms and misinformation perpetuated within families. Responding to the paucity of research on the implementation of SRH interventions in LMICs and limited knowledge regarding their mechanisms, this study undertakes a process evaluation of a parent-focused intervention to promote parent-adolescent communication about SRH in Uganda.MethodsThis paper explores the implementation, contextual factors and mechanisms of impact of the intervention, using the Medical Research Council (MRC) guidelines for process evaluations. Implementation was evaluated through indicators of dose, fidelity and adaptations, acceptability and feasibility. The contextual factors and mechanisms of impact were evaluated to refine the intervention’s causal assumptions. Data was collected during April - October 2021 in South-Western Uganda using a mixed-methods approach, including document analysis, intervention observations, interviews, focus group discussions and most significant change stories.ResultsThe acceptability of the intervention was related to its community engagement, the strong rapport with delivery agents, and individual characteristics of participants. Five contextual factors influencing implementation were highlighted; (i) cultural norms, (ii) perceptions about youth SRH, (iii) poverty, (iv) Covid-19 pandemic, and (v) prior research projects in the community. When considering the intervention’s mechanisms of impact, four causal pathways were identified; (i) Awareness of SRH needs helped parents overcome stigma, (ii) Parenting skills training improved SRH communication, (iii) Group learning stimulated shared parenting, and (iv) Group learning improved co-parenting.ConclusionThe paper presented three key learnings and corresponding recommendations for future research. Firstly, implementation success was credited to meaningful community engagement which improved acceptability and uptake. Secondly, the complex influences of contextual factors highlighted the need for contextual analysis in research studies to inform intervention design. Finally, this evaluation recognised the interplay between mechanisms of impact and suggested further research consider such combined impacts when designing intervention content.

Online peer support for people with Young Onset Dementia: development of a Best Practice Guidance

Objective:Peer support can be very valuable for people with Young Onset Dementia (YOD) (diagnosis before the age of 65). People with YOD often experience stigma, putting them at a higher risk of social isolation. In the United Kingdom, availability of age-appropriate, in-person peer support services is inconsistent, and as a result many people may miss out on the potential benefits. Online peer support could be a solution, as it overcomes geographical barriers, and offers a variety of platforms and modes of communication. This study aimed to explore how people with YOD experience online peer support, identify potential barriers to online peer support, and get insights into how online peer support can be optimized. The findings were used to develop a Best Practice Guidance on online peer support for people with YOD, and specific guidelines for facilitators of online peer support groups.Method:This study was conducted between October 2019 and December 2022. It followed the Medical Research Council (MRC) guidelines on complex interventions and focused on the development stage. The study consisted of multiple sub-studies, which all contributed to the Best Practice Guidance. The sub-studies included literature reviews, focus groups, an online survey, and interviews. All participants were people living with YOD.Results:Participants described online peer support as their lifeline which gave them hope and a sense of purpose again, after an often very difficult diagnostic and post-diagnostic period. For people in rural areas or who were unable to travel, online was the only way in which they could connect with their peers. However, many were unaware that online peer support exists, what it entails, and how they could get involved. This indicates a need for better advertisement of and signposting to (online) peer support.Conclusion:Online peer support can be beneficial for people with YOD. The Best Practice Guidance provides people with YOD with evidence-based information on what online peer support entails, facilitators with guidelines on how to optimize online peer support for people with YOD, and healthcare professionals with an opportunity to signpost people with YOD to online peer support.

Group Antenatal Care (gANC) for Somali-speaking women in Sweden – a process evaluation

Abstract Background Language supported group antenatal care (gANC) for Somali-born women was implemented in a Swedish public antenatal care clinic. Seven 60-minute sessions were offered, facilitated by midwives and starting with a presentation of a selected topic, with an additional 15-minute individual appointment before or after. The aim was to assess the feasibility for participants and midwives of implementing language supported gANC, including implementation, mechanisms of impact and contextual factors. Methods The Medical Research Council guidelines for evaluating complex interventions was used as a framework. Both qualitative and quantitative data sources including observations, in-depth and key-informant interviews (women n = 6, midwives n = 4, interpreters and research assistants n = 3) and questionnaire data (women n = 44; midwives n = 8) were used. Results gANC provided more comprehensive ANC and addressed knowledge gaps related to pregnancy, birth and the Swedish health care system. The majority of women thought listening to other pregnant women was valuable (91%), felt comfortable in the group (98%) and supported by the other women (79%), and they said that gANC suited them (79%). The intervention seemed to enhance cultural understanding among midwives, thus contributing to more women-centred care, but was not successful in involving partners. Conclusions Language-supported gANC was acceptable to participants and midwives, but did not lead to greater partner inclusion. Main mechanisms of impact were more comprehensive ANC and enhanced mutual cultural understanding. The position of women was strengthened, and the way in which the midwives expanded their understanding of the participants and their narratives was promising. To be feasible at a large scale, gANC might require further adaptations and the “othering” of women in risk groups should be avoided. Key messages • Group antenatal care seemed to enhance knowledge and cultural understanding among midwives, thus contributing to more women-centred care. • The “othering” of women in risk groups should be avoided.

Supporting Pain Self-Management in Patients With Cancer: App Development Based on a Theoretical and Evidence-Driven Approach.

To inform the development of an intervention, it is essential to have a well-developed theoretical understanding of how an intervention causes change, as stated in the UK Medical Research Council guidelines for developing complex interventions. Theoretical foundations are often ignored in the development of mobile health apps intended to support pain self-management for patients with cancer. This study aims to systematically set a theory- and evidence-driven design for a pain self-management app and specify the app's active features. The Behavior Change Wheel (BCW) framework, a step-by-step theoretical approach to the development of interventions, was adopted to achieve the aim of this study. This started by understanding and identifying sources of behavior that could be targeted to support better pain management. Ultimately, the application of the BCW framework guided the identification of the active contents of the app, which were characterized using the Behavior Change Technique Taxonomy version 1. The theoretical analysis revealed that patients may have deficits in their capability, opportunity, and motivation that prevent them from performing pain self-management. The app needs to use education, persuasion, training, and enablement intervention functions because, based on the analysis, they were found the most likely to address the specified factors. Eighteen behavior change techniques were selected to describe precisely how the intervention functions can be presented to induce the desired change regarding the intervention context. In other words, they were selected to form the active contents of the app, potentially reducing barriers and serving to support patients in the self-management of pain while using the app. This study fully reports the design and development of a pain self-management app underpinned by theory and evidence and intended for patients with cancer. It provides a model example of the BCW framework application for health app development. The work presented in this study is the first systematic theory- and evidence-driven design for a pain app for patients with cancer. This systematic approach can support clarity in evaluating the intervention's underlying mechanisms and support future replication.

Infection prevention and control in computed tomography: creating a national survey

BackgroundInfection prevention and control (IPC) is essential for quality healthcare, with healthcare associated infections (HAI) a known risk to patients requiring medical imaging (MI). To date, few papers have adopted a national approach to understanding or benchmarking the knowledge of, attitudes toward, and practice (KAP) of IPC in the context of MI and no validated surveys or scales are identified in the literature. The Computed Tomography (CT) suite is a unique MI environment where radiographers deliver prescription medicines to patients via intravenous (IV) means through an injector system. This paper describes the development of a survey that informs the use of IPC processes in the CT suite. MethodsStandard Precautions via current national guidelines formed the benchmark of the survey, with a KAP survey used as the framework to explore IPC. The questions and associated responses are developed based on the National Health and Medical Research Council (NHMRC) guidelines, industry/professional protocols and adapted to the equipment and practices commonly used in the CT suite of MI departments by radiographers and nurses. ResultsKey survey development steps are described to include the justification of the benchmarking source, the survey framework and design. Detailed information is given to show the evolution of truth statements and sources, KAP question variations, and rationales for the methodology of question responses. National guidelines are mapped to survey questions and responses and pilot testing reflections are included. ConclusionThis paper reports on the construction of a standardised KAP survey for IPC specific to the CT suite in the Australian healthcare setting. The survey is ready for dissemination amongst MI departments. Documented use will aid validation and reliability as a survey tool to measure and map IPC specifically in relation to IV contrast administration.

O.6.3-2 Implementation of a systems approach for co-creating actions to promote vocational students’ physical activity and wellbeing

Abstract Purpose Participatory systems approaches are suggested to address the complexity of health promotion in communities but has not been tested and adapted to school settings. The Data-driven Health Promotion at Vocational schools (Data Health) study aims to test and evaluate a systems approach to create collective actions to promote health among students. Three Group Model Building (GMB1-3) sessions were applied at eight vocational schools, with involvement from the local community, to develop a causal loop diagram (CLD), prioritise evidence-informed actions, and develop implementation strategies. This process evaluation aimed to determine if the GMB sessions were implemented as intended across intervention sites. Methods According to the Medical Research Council guidelines, six components were assessed: recruitment, reach, fidelity, dose delivered and received and context. Data included registration and observation notes from the workshops (n = 24) and recorded and transcribed qualitative interviews with the school programme-coordinators (n = 8). All data were analysed thematically. Results At all intervention sites GMB sessions were completed in 2022, with representation of students, school staff and managers, the municipal staff and local community actors. Based on local data, four intervention sites chose to target physical activity and four sites chose wellbeing. At most intervention sites, attendance (reach) from all participant groups fell below expectation. Especially recruitment of school staff (average no. of participants n = 1.75; range 0-3) and managers (average no. of participants n = 0.63; range 0-2) was challenging, with lack of time as the main reason for non-attendance. The expected 'dose' of the GMB sessions was delivered to participants, whereas fidelity, conceptualised as consistency in delivery, was mixed due to contextual circumstances e.g. school size. The school programme coordinators were generally positive about the GMB sessions but indicated mixed opinions about the value of CLDs to guide the discussion in this setting. Conclusions The Data Health study is the first to apply a systems approach to health promotion among vocational students and adapt GMB methodologies to school settings. Understanding the implementation of a systems approach in a school setting provides vital knowledge for researchers and practitioners regarding enablers and barriers of this approach. Funding Sources The Danish Regions, Tværspuljen, Helsefonden.

Evaluating the effectiveness of a multifaceted intervention to reduce low-value care in adults hospitalized following trauma: a protocol for a pragmatic cluster randomized controlled trial

BackgroundWhile simple Audit & Feedback (A&F) has shown modest effectiveness in reducing low-value care, there is a knowledge gap on the effectiveness of multifaceted interventions to support de-implementation efforts. Given the need to make rapid decisions in a context of multiple diagnostic and therapeutic options, trauma is a high-risk setting for low-value care. Furthermore, trauma systems are a favorable setting for de-implementation interventions as they have quality improvement teams with medical leadership, routinely collected clinical data, and performance-linked to accreditation. We aim to evaluate the effectiveness of a multifaceted intervention for reducing low-value clinical practices in acute adult trauma care.MethodsWe will conduct a pragmatic cluster randomized controlled trial (cRCT) embedded in a Canadian provincial quality assurance program. Level I–III trauma centers (n = 30) will be randomized (1:1) to receive simple A&F (control) or a multifaceted intervention (intervention). The intervention, developed using extensive background work and UK Medical Research Council guidelines, includes an A&F report, educational meetings, and facilitation visits. The primary outcome will be the use of low-value initial diagnostic imaging, assessed at the patient level using routinely collected trauma registry data. Secondary outcomes will be low-value specialist consultation, low-value repeat imaging after a patient transfer, unintended consequences, determinants for successful implementation, and incremental cost-effectiveness ratios.DiscussionOn completion of the cRCT, if the intervention is effective and cost-effective, the multifaceted intervention will be integrated into trauma systems across Canada. Medium and long-term benefits may include a reduction in adverse events for patients and an increase in resource availability. The proposed intervention targets a problem identified by stakeholders, is based on extensive background work, was developed using a partnership approach, is low-cost, and is linked to accreditation. There will be no attrition, identification, or recruitment bias as the intervention is mandatory in line with trauma center designation requirements, and all outcomes will be assessed with routinely collected data. However, investigators cannot be blinded to group allocation and there is a possibility of contamination bias that will be minimized by conducting intervention refinement only with participants in the intervention arm.Trial registrationThis protocol has been registered on ClinicalTrials.gov (February 24, 2023, #NCT05744154).

Single-arm, open-labelled, safety and tolerability of intrabronchial and nebulised bacteriophage treatment in children with cystic fibrosis and Pseudomonas aeruginosa

IntroductionCystic fibrosis (CF) is a multisystem condition that is complicated by recurrent pulmonary infections requiring aggressive antibiotic treatment. This predisposes the patient to complications such as sensorineural hearing loss, renal...

Artificial intelligence: Friend or foe?

Artificial intelligence: Friend or foe?