Medical Research Council Guidelines Research Articles

Process evaluation of a Structured E-parenting Support (STEPS) in the OPTIMA randomised controlled trial: a protocol.

Structured E-parenting Support (STEPS) is a digital application (app) designed to help parents manage behaviour of their children who are referred to mental health services and are waiting for an assessment or treatment. STEPS is currently being evaluated in the Online Parent Training for the Initial Management of Attention-Deficit/Hyperactivity Disorder randomised controlled trial. Alongside the examination of STEPS' clinical and cost-effectiveness, we are conducting a process evaluation to better understand the contextual factors that may influence study outcomes. The purpose of this protocol is to describe the aims, objectives and methodology of the process evaluation prior to it taking place to add to the fidelity and rigour of the trial process and outcomes. Our goal is to adapt STEPS to optimise its benefits in future applications. In line with the Medical Research Council guidelines for evaluating complex interventions, the process evaluation will adopt a mixed method design using qualitative data collected from clinicians and parent interviews and app usage data from participants assigned to the intervention arm. Qualitative data from semistructured interviews and free text box responses included in trial questionnaires will be analysed thematically using framework analysis to better understand how parents use STEPS, how it works and key factors that could aid or hinder its effective implementation in routine clinical practice. The application for ethical approval for the study was submitted to the North West-Liverpool Central Research Ethics Committee and received a favourable opinion on further information on 26 November 2021, reference number 21/NW/0319. The process evaluation aims to explore how a digital app might support parents in managing their child's behaviour. Implications for policy and research will be explored and the clinical implications of offering the app to a wider audience to address the lack of support to parents as highlighted in this paper. We plan to publish findings in international, peer-reviewed journals as well as present at conferences. The trial has been prospectively registered on 18 November 2021; ISRCTN816523503. https://www.isrctn.com/ISRCTN16523503.

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?

What and how do different stakeholders contribute to intervention development? A mixed methods study.

Background: UK Medical Research Council guidelines recommend end-user involvement in intervention development. There is limited evidence on the contributions of different end-users to this process. The aim of this Study Within A Trial (SWAT) was to identify and compare contributions from two groups of end-users - people with diabetes' (PWD) and healthcare professionals' (HCPs), during consensus meetings to inform an intervention to improve retinopathy screening uptake. Methods: A mixed method, explanatory sequential design comprising a survey and three semi-structured consensus meetings was used. PWD were randomly assigned to a PWD only or combined meeting. HCPs attended a HCP only or combined meeting, based on availability. In the survey, participants rated intervention proposals on acceptability and feasibility. Survey results informed the meeting topic guide. Transcripts were analysed deductively to compare feedback on intervention proposals, suggestions for new content, and contributions to the final intervention. Results: Overall, 13 PWD and 17 HCPs completed the survey, and 16 PWD and 15 HCPs attended meetings. For 31 of the 39 intervention proposals in the survey, there were differences (≥10%) between the proportion of HCPs and PWD who rated proposals as acceptable and/or feasible. End-user groups shared and unique concerns about proposals; both were concerned about informing but not scaring people when communicating risk, while concerns about resources were mostly unique to HCPs and concerns about privacy were mostly unique to PWD. Fewer suggestions for new intervention content from the combined meeting were integrated into the final intervention as they were not feasible for implementation in general practice. Participants contributed four new behaviour change techniques not present in the original proposals: goal setting (outcome), restructuring the physical environment, material incentive (behaviour) and punishment. Conclusions: Preferences for intervention content may differ across end-user groups, with feedback varying depending on whether end-users are involved simultaneously or separately.

Group antenatal care (gANC) for Somali-speaking women in Sweden – a process evaluation

BackgroundLanguage supported group antenatal care (gANC) for Somali-born women was implemented in a Swedish public ANC clinic. The women were offered seven 60-min sessions, facilitated by midwives and starting with a presentation of a selected topic, with an additional 15-min individual appointment before or after. The aim of this study was to assess the feasibility for participants and midwives of implementing The Hooyo (“mother” in Somali) gANC intervention, including implementation, mechanisms of impact and contextual factors.MethodsA process evaluation was performed, using The Medical Research Council (MRC) guidelines for evaluating complex interventions as a framework. A range of qualitative and quantitative data sources were used including observations (n = 9), complementary, 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).ResultsLanguage-supported gANC offered more comprehensive ANC that seemed to correspond to existing needs of the participants and could address 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 knowledge and cultural understanding among midwives, thus contributing to more women-centred care. The intervention was not successful at involving partners in ANC.ConclusionsThe Hooyo gANC intervention was acceptable to the Somali women and to midwives, but did not lead to greater participation by fathers-to-be. The main mechanisms of impact were more comprehensive ANC and enhanced mutual cultural understanding. The position of women was strengthened in the groups, 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.Trial registrationThe study was registered in ClinicalTrials.gov (Identifier: NCT03879200).

Implementation of a Health Promotion Practice Using Individually Targeted Lifestyle Interventions in Primary Health Care: Protocol for the "Act in Time" Mixed Methods Process Evaluation Study.

BackgroundThere is growing evidence that noncommunicable diseases (NCDs) can be attributable to unhealthy lifestyle habits. However, there has been little application of this knowledge in primary health care (PHC).ObjectiveThis study aims to evaluate the process and outcomes of a multifaceted implementation strategy for a healthy lifestyle-promoting practice in a PHC setting. This practice is based on national guidelines targeting unhealthy lifestyle habits with a potential risk for NCDs.MethodsA pre-post implementation study design with a control group is used in a PHC setting in central Sweden. The Medical Research Council guidelines for process evaluation of complex interventions will be applied. The implementation process and outcomes will be assessed using a mix of qualitative and quantitative methods. A strategic sample of up to 6 PHC centers will be included as intervention centers, which will receive a 12-month multifaceted implementation strategy. Up to 6 matched PHC centers will serve as controls. Core components in the implementation strategy are external and internal facilitators in line with the integrated-Promoting Action on Research Implementation in Health Services (i-PARIHS) framework and the Astrakan change leadership model. Data will be collected at baseline, during the implementation phase, and 4-6 months after the implementation strategy. Questionnaires will be sent to roughly 500 patients in every PHC center and 200 health care professionals (HCPs) before and after implementation. In addition, purposeful sampling will be used for interviews and focus group discussions with managers, HCPs, patient representatives, and internal and external facilitators. Use of data from medical records and activity logs will be an additional data source.ResultsRecruitment of PHC centers began in March 2021 and ended in Spring 2022. Based on the planned timeline with the 12-month implementation strategy and 4-6-month follow-up, we expect to collect the final data in Summer 2023.ConclusionsThis study will explain implementation process and outcomes using a multifaceted implementation strategy for a healthy lifestyle-promoting practice in a real-world PHC context. The study is expected to provide new knowledge about the role of facilitators and their contribution to implementation outcomes. These findings can guide policy makers, managers, and PHC staff to integrate health promotion and disease prevention in PHC and provide methodological support to facilitators.Trial RegistrationClinicalTrials.gov NCT04799860; https://clinicaltrials.gov/ct2/show/NCT04799860International Registered Report Identifier (IRRID)DERR1-10.2196/37634

Assessing the impact of the 2018 National Health and Medical Research Council polyp surveillance guidelines on compliance with surveillance intervals at two public hospitals.

Several studies have highlighted poor compliance with surveillance colonoscopy guidelines. The National Health and Medical Research Council (NHMRC) guidelines were revised in 2018 and were more complex than the previous iteration (2011). The aim of this study was to determine the impact of 2018 NHMRC polyp surveillance guidelines on compliance with colonoscopy surveillance intervals. A multicentre retrospective clinical audit was conducted between January 2020 and February 2021. Patients awaiting a colonoscopy for polyp surveillance at two public tertiary care hospitals in South Australia were included. Compliance rates of recommended polyp surveillance colonoscopy intervals after implementation of 2018 NHMRC guidelines were compared with 2011 NHMRC guidelines. The projected impact on colonoscopy bookings of the change in guideline intervals was modelled to 5 and 10 years, factoring in differences in compliance. Of 3996 patients awaiting colonoscopy services at two public hospitals in South Australia, 1984 patients (60% male, median age 61 years) were waitlisted for polyp surveillance. Overall compliance with surveillance guidelines was >60%. Implementation of the 2018 NHMRC guidelines significantly reduced compliance from 65.8% (2011 guidelines) to 50.8% (2018) (χ2 <0.001, OR 0.5). Modelling projections to 5 and 10 years demonstrated that application of the 2018 guidelines significantly increases the projected number of colonoscopy bookings per year. The revised 2018 NHMRC guidelines have resulted in significantly poorer compliance post-implementation, possibly due to their increased complexity. This has potential to increase the surveillance colonoscopy waiting list burden.

What and how do different stakeholders contribute to intervention development? A mixed methods study.

Background: UK Medical Research Council guidelines recommend end-user involvement in intervention development. There is limited evidence on the contributions of different end-users to this process. The aim of this Study Within A Trial (SWAT) was to identify and compare contributions from two groups of end-users - people with diabetes' (PWD) and healthcare professionals' (HCPs), during consensus meetings to inform an intervention to improve retinopathy screening uptake. Methods: A mixed method, explanatory sequential design comprising a survey and three semi-structured consensus meetings was used. PWD were randomly assigned to a diabetes only or combined meeting. HCPs attended a HCP only or combined meeting, based on availability. In the survey, participants rated intervention proposals on acceptability and feasibility. Survey results informed the meeting topic guide. Transcripts were analysed deductively to compare feedback on intervention proposals, suggestions for new content, and contributions to the final intervention. Results: Overall, 13 PWD and 17 HCPs completed the survey, and 16 PWD and 15 HCPs attended meetings. For 31 of the 39 intervention proposals in the survey, there were differences (≥10%) between the proportion of HCPs and PWD who rated proposals as acceptable and/or feasible. End-user groups shared and unique concerns about proposals; both were concerned about informing but not scaring people when communicating risk, while concerns about resources were mostly unique to HCPs and concerns about privacy were mostly unique to PWD. Fewer suggestions for new intervention content from the combined meeting were integrated into the final intervention as they were not feasible for implementation in general practice. Participants contributed four new behaviour change techniques not present in the original proposals: goal setting (outcome), restructuring the physical environment, material incentive (behaviour) and punishment. Conclusions: Preferences for intervention content may differ across end-user groups, with feedback varying depending on whether end-users are involved simultaneously or separately.

Reducing exacerbations in children and adults with primary ciliary dyskinesia using erdosteine and/or azithromycin therapy (REPEAT trial): study protocol for a multicentre, double-blind, double-dummy, 2×2 partial factorial, randomised controlled trial

IntroductionPrimary ciliary dyskinesia (PCD) is a rare, progressive, inherited ciliopathic disorder, which is incurable and frequently complicated by the development of bronchiectasis. There are few randomised controlled trials (RCTs) involving...