Medical Research Council Framework Research Articles

Prevention of physical restraints in the acute care setting (PROTECT): study protocol for a cluster-randomised controlled pilot study

IntroductionPhysical restraints (PR) are regularly used in acute care settings, although evidence for their effectiveness and safety (eg, for prevention of falls) is lacking. Their use is associated with adverse...

‘C’mon, let’s talk: a pilot study of mental health literacy program for Filipino migrant domestic workers in the United Kingdom

PurposeThis pilot study of a culturally adapted online mental health literacy (MHL) program called ‘Tara, Usap Tayo!’ (C’mon, Let’s Talk) aims to assess the acceptability, appropriateness, feasibility, and potential effectiveness in improving the help-seeking behavior of Filipino migrant domestic workers in the United Kingdom (UK).MethodsUsing mixed methods, we conducted a non-randomized single-group study of the online MHL program with 21 participants. The development of this intervention was guided by the Medical Research Council Framework for developing complex interventions and utilized Heim & Kohrt’s (2019) framework for cultural adaptation. Content materials from the WHO Mental Health Gap Action Program (mhGAP), WHO Problem Management Plus (PM +) and Adult Improving Access to Psychological Therapies (IAPT) were modified and translated into the Filipino language. The MHL program was delivered online in three sessions for two hours each session. Data were collected at three time points: (T1) pretest; (T2) posttest; and (3) follow-up test. Quantitative data on participants’ attitudes towards help-seeking and level of mental health literacy as outcome measures of potential intervention effectiveness were collected at T1, T2 and T3, while focus group discussions (FGDs) to assess participants’ feedback on the acceptability, feasibility, and appropriateness of the online MHL program were conducted immediately at T2. Data analysis was done using a thematic approach for qualitative data from the FGDs and descriptive statistics and repeated-measures ANOVA were used to assess the difference in the T1, T2, and T3 tests. Both quantitative and qualitative results were then integrated and triangulated to answer the research questions.ResultsThe online MHL program is generally acceptable, appropriate, and feasible for use among Filipino migrant domestic workers. Preliminary findings lend support for its possible effectiveness in improving mental health literacy and help-seeking propensity. The cultural adaptation made in the content, form, and delivery methods of the intervention was acceptable and feasible for this target subcultural group.ConclusionBy improving their mental health literacy and help-seeking propensity, this online MHL program has the potential to provide support to the mental health and well-being of Filipino migrant domestic workers in the UK. Further feasibility study or large-scale randomized controlled trial is needed to confirm the preliminary findings of this study.

Development of an evidence‑based, theory‑driven, and culturally appropriate character strengths-based intervention for breast cancer patients, following the Medical Research Council Framework.

To design and develop a complex, evidence‑based, theory‑driven, and culturally appropriate character strengths-based intervention (CSI) for breast cancer patients, following the Medical Research Council (MRC) framework. From 2018 September to 2020 November, a complex intervention perspective was adopted. The rationale, methods, and processes employed in carrying out the study were reported. The acceptability and feasibility of intervention program were evaluated as a part of subsequent pilot study. Based on piloting, a refined and optimized definitive intervention was obtained. The development of the intervention is an iterative process involving input from three key stakeholders: experts, medical staff, and patient representatives. The systematic review revealed CSIs were effective and the selected theory served as a guide and indicated theory-inspired modifications. A representative team of breast cancer patients and oncology nurses collaboratively developed and tailored the intervention content and format with attention to the acceptability and feasibility. Five main strategies, including peripheral, evidential, linguistic, constituent-involving, and sociocultural strategies, were used to achieve and strengthen the cultural appropriateness. After the pilot phase, several refinements were made on the CSI program, such as editorial changes in the booklet or alternative suggestions for difficult strengths-based activities (e.g., outdoor activities). All participants not only expressed satisfaction with the program in process evaluation, but also reported perceived benefits such as enjoyable and sociable experience, better well-being, and increased confidence. Consideration of the MRC framework, theory guidance, and suggestions from stakeholders during intervention development can optimize uptake and sustainability in the clinical setting. It is recommended that randomized controlled trial be used in future studies to assess the intervention, the process and the mechanisms of the intervention. Our approach may offer implications for the design and implementation of similar initiatives to support cancer patients. ClinicalTrials.gov Register Identifier: NCT04219267, 07/01/2020, retrospectively registered.

Study protocol for the implementation and evaluation of a digital-robotic-based intervention for nurses and patients in a hospital: a quantitative and qualitative triangulation based on the Medical Research Council (MRC) framework for developing and evaluating complex interventions.

Nurses spend part of their working time on non-nursing tasks. Unnecessary walking distances and the assumption of service activities and other non-care-related tasks take up a lot of space, which reduces the time for direct patient care and demonstrably increases the dissatisfaction of the persons involved. The REsPonSe project aims to relieve nursing staff by using a smartphone app for communication in combination with an autonomous service robot to reduce walking distances and service activities. The technical systems are tested on a nuclear medicine ward and are intended to reduce the radiation exposure of the staff. The aim of this study is to test and evaluate the use and intervention of the technical systems, the acceptance of the users and the change in the utilisation of the nursing service. In addition to findings on usability and manageability, effects on nursing practice, as well as facilitating and inhibiting contextual factors for implementation, will be identified. The Medical Research Council (MRC) Framework for Developing and Evaluating for Complex Interventions was chosen as the theoretical basis. The data collection in the Feasibility and Evaluation phase is a triangulation of quantitative and qualitative methods. Standardised observations are planned to collect data on non-care activities and walking distances, and a survey of utilisation by use of a questionnaire based on the NASA TLX. Qualitative individual interviews with patients and group discussions with nursing staff will be conducted. Statements on the subjective experiences, as well as the evaluation of the use of the digital-robotic system in the clinical setting, will be collected. The descriptive evaluation of the usage and retrieval data will provide information on duration, time, requests, and reduced contact times, as well as error and fault messages. The evaluation study will make it possible to represent a variety of perspectives from different interest groups. The results should contribute to the definition of implementation and evaluation criteria and facilitate the integration of digital-robotic assistance systems in nursing acute inpatient settings. The trial was registered with the German Clinical Trials Register (DRKS) on 16.02.2022: DRKS00028127.

Development of a Psychological Intervention to Improve Depressive Symptoms and Enhance Adherence to Antiretroviral Therapy among Adolescents and Young People Living with HIV in Dar es Salaam Tanzania.

Background: Interventions that simultaneously target depression and antiretroviral therapy (ART) medication adherence are recommended for improving HIV treatment outcomes and quality of life for adolescents living with HIV. However, evidence is scarce on culturally feasible and acceptable interventions that can be implemented for HIV-positive adolescents in Tanzania. We, therefore, developed a manualized brief psychological intervention that utilizes evidence-based strategies to address depression and ART adherence in adolescents living with HIV in Tanzania. Methods: We used the Theory of Change Enhanced Medical Research Council framework (TOCMRC) for developing complex interventions in health care to develop the intervention in five phases. First, the literature was reviewed to identify potential intervention components. Second, we conducted a situational analysis using qualitative interviews with adolescents living with HIV, health care providers, and caregivers. Third, we conducted a mental health expert workshop; and fourth, theory of change workshops with representatives from the Ministry of Health, mental health professionals, HIV implementing partners, adolescents, and healthcare providers. Lastly, we synthesized results to finalize the intervention and a theory of change map showing the causal pathway for how we expect the developed intervention to achieve its impact. Results: Adolescents living with HIV in Tanzania experience several unmet mental health needs ranging from overwhelming depressive symptoms to not feeling understood by healthcare providers who lack mental health knowledge. Participants perceived psychological intervention that utilizes a task-shifting approach to be acceptable and beneficial to addressing those problems. The novel components of the NITUE intervention included incorporating evidence-based intervention components, namely, cognitive-behavioral therapy, motivational interviewing, and problem solving. In addition, caregiver inclusion in the treatment was essential to ensure access to care, compliance, and improved outcomes. Conclusions: A culturally appropriate brief psychological intervention that utilizes a task-shifting approach to address depression and medication adherence for adolescents living with HIV in Dar es Salaam, Tanzania, was developed. The intervention will be piloted for appropriateness, feasibility, and acceptability and will provide material for a future trial to determine its effectiveness.

Personalised exercise therapy and self-management support for people with multimorbidity: Development of the MOBILIZE intervention

BackgroundTo our knowledge, there is no intervention which includes personalised exercise therapy and self-management support for people with multimorbidity, although these interventions may be as effective as for people with single chronic conditions. Therefore, we developed a novel intervention, including personalised exercise therapy and self-management support for people with multimorbidity.MethodsWe followed the Medical Research Council framework and conducted one scoping review, five systematic reviews, two registry-based studies, one qualitative interview study and a mixed-methods feasibility study. Following an iterative approach, together with feedback from people with multimorbidity and relevant stakeholders, we developed the MOBILIZE intervention.ResultsThe intervention included 24 (60 minutes) sessions of personalised exercise therapy and 24 (30 minutes) sessions of self-management support twice a week for 12 weeks, delivered in small groups by specifically trained physiotherapists. The intervention targets physiological, psychosocial, behavioural, and contextual factors to improve health-related quality of life and physical function in people living with multimorbidity.ConclusionsWe developed a personalised exercise therapy and self-management support programme for people with multimorbidity. The intervention will be tested for its safety and effectiveness in a randomised controlled trial.

Gently steering - the mechanism of how motivational interviewing supported walking after hip fracture: A qualitative study.

To explore how older adults perceive motivational interviewing influences their walking and physical activity after hip fracture. Qualitative study using an interpretive description framework. Twenty-four participants aged ≥65 years living in the community after hip fracture were interviewed. Participants had received at least 8 sessions of motivational interviewing via telephone. Semi-structured interviews were transcribed verbatim and coded inductively by two researchers independently. All authors discussed findings and themes observed through the researchers' lens and mapped them to the Medical Research Council's framework for process evaluation. Motivational interviewing was described as a nuanced and subtle intervention that guided participants through their journey of recovery. Three themes described possible mechanisms of how motivational interviewing might work: connection, checking in and confidence. In the context of recovering from hip fracture psychologically and physically, a strong connection with clinicians, along with weekly checking in, were perceived to build participants' confidence to walk after hip fracture. This study provided insight on participant perceptions of how motivational interviewing might work to support walking after hip fracture. The addition of motivational interviewing to rehabilitation is a novel way of building confidence to walk for people recovering from hip fracture.

Development and Validation of an Evidence-Based Breathing Exercise Intervention Protocol for Chronic Pain Management in Breast Cancer Survivors

BackgroundBreathing exercise has been utilized as a promising approach to pain management in cancer survivors. However, the development process of the breathing exercise intervention protocol was rarely reported. AimTo develop an evidence-based breathing exercise intervention protocol for chronic pain management in breast cancer survivors and to provide a detailed account of the intervention development process. MethodsThe study design was guided by the Medical Research Council Framework for Developing and Evaluating Complex Intervention. The breathing exercise intervention development process adopted phase one of the Medical Research Council Framework for Developing and Evaluating Complex Intervention framework. The content validity index was applied to determine the consensus of the appropriateness of the breathing exercise intervention protocol among the panel experts. ResultsThe preliminary breathing exercise intervention protocol was developed based on fight-or-flight theory and vagus nerve theory, and the best available research evidence identified from seven systematic reviews, three clinical trials, and four practice recommendations. The breathing exercise intervention was designed as slow deep pursed-lip breathing with a time ratio of inspiration to expiration 1:2-3. The intensity of the breathing exercise was determined as 3 to 5 sessions a day, 5 minutes per session, for 4 weeks. The content validity of the breathing exercise intervention protocol was excellent as consensus was achieved among all panel experts with both the item-level and scale-level CVIs reaching 1.0. ConclusionsThis study developed an evidence-based breathing exercise intervention protocol for chronic pain management in breast cancer survivors. The protocol is well-supported by the relevant theories, research evidence, practice recommendations, and experts’ consensus.

An Early Biopsychosocial Intervention Design for the Prevention of Low Back Pain Chronicity: A Multidisciplinary Empirical Approach.

Comprehensive intervention models for prevention of chronification of low back pain, in which the early identification of holistic risk factors is considered are needed. The aim of this study is to design a tailored biopsychosocial intervention for patients with low back pain to prevent pain chronicity. A multidisciplinary empirical approach. A multidisciplinary team designed a biopsychosocial intervention following an application from the Medical Research Council's complex intervention framework. The methods used included problem identification, identification of the evidence, theory, and needs, examination of the current context and modelling of the theory. Biomechanical, psychological, social and environmental, and lifestyle and personal risk factors were taken into account. The intervention process was introduced in a logic model. The model presents all the required resources, their activities and outputs, as well as the outcomes and impacts of the intervention. The intervention was tailored according to the underlying risk factors for pain chronification in patients with low back pain. A comprehensive tailored intervention may decrease the risk of pain chronicity. Further studies are needed to obtain information on the feasibility, effectiveness and cost-effectiveness of such interventions.

Managing Minds at Work: development of a digital line manager training programme

Abstract Background Mental ill health is the leading cause of sickness absence with high economic burden. Workplace interventions aimed at supporting employers with prevention of mental ill-health in the workforce are urgently required. Managing Minds at Work (MMW) is a digital intervention targeting support for line managers in any work setting to promote better mental health at work through a preventative approach. Objectives To describe the design and development of the MMW digital training programme, prior to feasibility testing. We adopted a collaborative participatory design involving co-design (users as partners) and principles of user-centred design (pilot and usability testing). Agile methodology was used to co-create intervention content with a stakeholder community of practice. Development processes were mapped to core elements of the Medical Research Council (MRC) framework for developing and evaluating complex interventions. Results The program covers five broad areas: (i) promoting self-care techniques among line managers; (ii) designing work to prevent work-related stress; (iii) management competencies to prevent and reduce stress; (iv) having conversations with employees about mental health; (v) building a psychologically safe work environment. Pilot and usability testing (n = 37 surveys) aligned with the Technology Acceptance Model (TAM) demonstrated that MMW was perceived to be useful, relevant, and easy to use by managers across sectors, organization types and sizes. We identified positive impacts on manager attitudes and behavioural intentions related to preventing mental ill-health and promoting good mental well-being at work. Conclusions MMW is a digital training programme for line managers that has been co-created using rigorous development processes and aims to support employers with primary prevention in mental health. The next step is to explore the feasibility and acceptability of this intervention with line managers in diverse employment settings. Key messages

Codevelopment and evaluation of a multicomponent intervention to improve HPV vaccination in France

Abstract Background HPV vaccine coverage (VC) in France has always been lower than in most high-income countries. The French authorities launched in 2018 the PrevHPV national research program aimed at codeveloping with stakeholders and evaluating the impact of a multicomponent intervention to improve HPV VC among French adolescents. Methods We identified three components to address main barriers to HPV vaccination in France: adolescents’ and parents’ education and motivation (component 1); general practitioners (GPs)’ training (component 2); and access to vaccination at school (component 3). We developed the intervention using the UK Medical Research Council framework for developing complex interventions as a guide. We used (i) findings from published evidence; (ii) primary data on knowledge, attitudes, behavior and preferences collected through a mixed methods approach (quantitative/qualitative studies, discrete choice experiment); (iii) the advice of stakeholders (e.g., adolescents, parents, school nurses, GPs) involved in working groups. We will evaluate the effectiveness, efficiency and implementation of the components (applied alone or in combination) through a pragmatic cluster randomized controlled trial. The primary endpoint is the HPV VC (≥ 1 dose) among adolescents aged 11-14 years, 2 months after the end of the intervention, at the municipality level. Results Primary data highlighted the need to improve adolescents, parents and school staff knowledge on HPV and to help GPs communicate with patients on this topic. They provided guidance on the most effective communication contents. For each component, we codeveloped tools with a participatory approach (e.g., eHealth tools for adolescents, a decision aid tool for GPs). The trial will end in June 2022; 90 middle schools (i.e., about 40,000 adolescents) and 46 GPs accepted to participate. Conclusions Should the intervention prove effective, results from the implementation evaluation will help us refine it before scaling it up. Key messages • The PrevHPV study is supported by the French health authorities and conducted by a multidisciplinary consortium to tackle a long-lasting public health concern in France. • It will add to the small number of studies that compared the effectiveness of various strategies to promote HPV vaccination and will provide key results on cost-effectiveness and implementation.

Shared decision-making and planning end-of-life care for patients with end-stage kidney disease: a protocol for developing and testing a complex intervention

BackgroundInternationally, it has been stressed that advance care planning integrated within kidney services can lead to more patients being involved in decisions for end-of-life care. In Denmark, there is no systematic approach to advance care planning and end-of-life care interventions within kidney services. A shared decision-making intervention for planning end-of-life care may support more effective treatment management between patients with end-stage kidney disease, their relatives and the health professionals. The purpose of this research is to find evidence to design a shared decision-making intervention and test its acceptability to patients with end-stage kidney disease, their relatives, and health professionals in Danish kidney services.MethodsThis research project will be conducted from November 2020 to November 2023 and is structured according to the UK Medical Research Council framework for complex intervention design and evaluation research. The development phase research includes mixed method surveys. First, a systematic literature review synthesising primary empirical evidence of patient-involvement interventions for patients with end-stage kidney disease making end-of-life care decisions will be conducted. Second, interview methods will be carried out with patients with end-stage kidney disease, relatives, and health professionals to identify experiences of involvement in decision-making and decisional needs when planning end-of-life care. Findings will inform the co-design of the shared decision-making intervention using an iterative process with our multiple-stakeholder steering committee. A pilot test across five kidney units assessing if the shared decision-making intervention is acceptable and feasible to patients, relatives, and health professionals providing services to support delivery of care in kidney services.DiscussionThis research will provide evidence informing the content and design of a shared decision-making intervention supporting patient-professional planning of end-of-life care for patients with end-stage kidney disease, and assessing its acceptability and feasibility when integrated within Danish kidney units. This research is the first step to innovating the involvement of patients in end-of-life care planning with kidney professionals.

Development of an intervention (PICASO) to optimise the palliative care capacity of social workers in Flanders: a study protocol based on phase I of the Medical Research Council framework

IntroductionAn important challenge for future palliative care delivery is the growing number of people with palliative care needs compared with the limited qualified professional workforce. Existing but underused professional potential...

Practice Programme for Upright Positions in the Second Stage of Labour: The development of a complex intervention based on the Medical Research Council framework.

This study aimed to develop a Practice Programme for Upright Positions in the Second Stage of Labour to provide a reference for midwifery professionals in the standardized implementation of upright positions in clinical practice. The adoption of upright positions in the second stage of labour is recommended by many international organizations, but upright positions have not been widely used and their implementation varies greatly across studies. The Practice Programme for Upright Positions in the Second Stage of Labour was developed under the guidance of the Medical Research Council framework for developing and evaluating complex interventions and the World Health Organization handbook for guideline development. Four stages were conducted: (1) establishing the intervention development group, (2) identifying a theoretical basis and forming a content framework, (3) evidence retrieval and synthesis and (4) refining and modelling the practice programme. The content framework of the Practice Programme for Upright Positions in the Second Stage of Labour was formed based on the literature review, semi-structured interviews and expert consultation, including indications and contraindications, implementation methods, observations, potential risks and precautions. According to each item, we conducted a series of systematic reviews, and summarized the available best evidence from clinical guidelines, systematic reviews and original studies. Eventually, the Practice Programme for Upright Positions in the Second Stage of Labour was developed, integrating the findings of the iterative evidence reviews and revised by stakeholders. This study first reported the development process of the Practice Programme for Upright Positions in the Second Stage of Labour, characterized by evidence-based, iteratively processed and highly rigorous. The implications may guide researchers to embed the intervention normatively into clinical practice for improving maternal and infant outcomes. The Practice Programme for Upright Positions in the Second Stage of Labour could facilitatesystematic management of labour positions and guide midwives in the successful implementation of upright positions.

Development of a Psychoeducational Foster Carer Program Using the Medical Research Council (MRC) Framework for Complex Interventions

Foster carers require high quality evidence-based psychoeducational programs to support them in the care of children with complex trauma-related difficulties. However, there is a lack of systematic development of such programs which may explain mixed results. This paper presents a detailed account of the development of a complex intervention. This program was developed to address a practice gap of evidenced-based foster care programs in the Irish context. It aims to improve foster carers' capacity to provide children with trauma-informed care and in turn improve emotional and behavioural difficulties. The framework of the Medical Research Council (MRC) for the development and evaluation of complex interventions was used to develop Fostering Connections: The Trauma-informed Foster Care Programme. A prior narrative review of the evidence base of similar programs was combined with a prior qualitative study. A Stakeholder Group provided expert feedback during the development process. The development of a promising psychoeducational programs for foster carers using the MRC framework is described

Clinical ethics consultations: a scoping review of reported outcomes

BackgroundClinical ethics consultations (CEC) can be complex interventions, involving multiple methods, stakeholders, and competing ethical values. Despite longstanding calls for rigorous evaluation in the field, progress has been limited. The Medical Research Council (MRC) proposed guidelines for evaluating the effectiveness of complex interventions. The evaluation of CEC may benefit from application of the MRC framework to advance the transparency and methodological rigor of this field. A first step is to understand the outcomes measured in evaluations of CEC in healthcare settings.ObjectiveThe primary objective of this review was to identify and map the outcomes reported in primary studies of CEC. The secondary objective was to provide a comprehensive overview of CEC structures, processes, and roles to enhance understanding and to inform standardization.MethodsWe searched electronic databases to identify primary studies of CEC involving patients, substitute decision-makers and/or family members, clinicians, healthcare staff and leaders. Outcomes were mapped across five conceptual domains as identified a priori based on our clinical ethics experience and preliminary literature searches and revised based on our emerging interpretation of the data. These domains included personal factors, process factors, clinical factors, quality, and resource factors.ResultsForty-eight studies were included in the review. Studies were highly heterogeneous and varied considerably regarding format and process of ethical intervention, credentials of interventionist, population of study, outcomes reported, and measures employed. In addition, few studies used validated measurement tools. The top three outcome domains that studies reported on were quality (n = 31), process factors (n = 23), and clinical factors (n = 19). The majority of studies examined multiple outcome domains. All five outcome domains were multidimensional and included a variety of subthemes.ConclusionsThis scoping review represents the initial phase of mapping the outcomes reported in primary studies of CEC and identifying gaps in the evidence. The confirmed lack of standardization represents a hindrance to the provision of high quality intervention and CEC scientific progress. Insights gained can inform the development of a core outcome set to standardize outcome measures in CEC evaluation research and enable scientifically rigorous efficacy trials of CEC.

An interactive web-based programme on relapse management for people with multiple sclerosis (POWER@MS2) - development, feasibility, and pilot testing of a complex intervention.

IntroductionDespite the lack of high-quality evidence regarding its long-term effectiveness, intravenous corticosteroid therapy is recommended as the standard treatment of acute multiple sclerosis relapses in Germany. High financial expenses and the equivalent effectiveness of oral corticosteroid therapy contrast with this trend. There is an urgent need to provide patients with evidence-based and comprehensible information on relapse management and to actively involve patients in relapse treatment decisions. Web-based decision support on relapse management could be an effective measure to empower people with multiple sclerosis making informed treatment decisions.ObjectivesTo develop a web-based programme on relapse management for people with multiple sclerosis and evaluate the feasibility and acceptability of the intervention.MethodsThe study followed the first two phases of the UK Medical Research Council Framework for complex interventions. The first phase involved the development of an interactive web-based programme on relapse management. The second phase focused on the feasibility and pilot testing of the programme with people with multiple sclerosis and experts with a professional background in multiple sclerosis. Data was obtained using questionnaires with closed- and open-ended questions as well as qualitative semi-structured telephone interviews. Quantitative data was analyzed descriptively, whereas qualitative data was clustered by topic.ResultsFeasibility of the intervention programme was tested with 10 people with multiple sclerosis and 10 experts. Feasibility testing indicated good practicability and acceptance of the content. After revision, the programme was piloted with seven people with multiple sclerosis and three experts. The results showed good acceptance in both groups. Based on the feedback, a final revision was performed.ConclusionFeasibility and pilot testing indicated good user-friendliness, acceptance, and practicability of the programme. The programme is currently evaluated in a randomized controlled trial (Registration Number on ClinicalTrials.gov: NCT04233970). It is expected that the programme will have a positive impact on patients' relapse management and strengthen their autonomy and participation.

Leading radiography research to deliver clinical outcomes

Leading radiography research to deliver clinical outcomes

Adapting an intervention of brief problem-solving therapy to improve the health of women with antenatal depressive symptoms in primary healthcare in rural Ethiopia

BackgroundEvidence-based brief psychological interventions are safe and effective for the treatment of antenatal depressive symptoms. However, the adaptation of such interventions for low- and middle-income countries has not been prioritised. This study aimed to select and adapt a brief psychological intervention for women with antenatal depressive symptoms attending primary healthcare (PHC) in rural Ethiopia.MethodsWe employed the Medical Research Council (MRC) framework for the development and evaluation of complex interventions. Alongside this, we used the ADAPT-ITT model of process adaptation and the ecological validity model (EVM) to guide content adaptation. We conducted formative work, comprising a qualitative study, a series of three participatory theories of change workshops and an expert adaptation workshop to assess the needs of the target population and to select an intervention for adaptation. The adaptation process followed a series of steps: (1) training Ethiopian mental health experts in the original South African problem-solving therapy (PST version 0.0) and an initial adaptation workshop leading to PST Version 1.0. (2) Version 1.0 was presented to perinatal women and healthcare professionals in the form of a ‘theatre test’, leading to further adaptations (version 2.0). (3) Local and international stakeholders reviewed version 2.0, leading to version 3.0, which was used to train 12 PHC staff using clinical cases. (4) Finally, feedback about PST version 3.0 and its delivery was obtained from PHC staff.ResultsIn the first step, we modified case examples and terminology from the South African model, introduced an in-session pictorial flipchart for this low literacy setting, and added strategies to facilitate women’s engagement before translating into Amharic. In the second step, adaptations included renaming of the types of problems and inclusion of more exercises to demonstrate proposed coping strategies. In the third step, the components of motivational interviewing were dropped due to cultural incongruence. In the final step, refresher training was delivered as well as additional training on supporting control of women’s emotions to address PHC staff training needs, leading to the final version (version 4.0).ConclusionUsing a series of steps, we have adapted the content and delivery of brief PST to fit the cultural context of this setting. The next step will be to assess the feasibility and acceptability of the intervention and its delivery in antenatal care settings.

Process evaluation of a pragmatic implementation trial to support self-management for the prevention and management of type 2 diabetes in Uganda, South Africa and Sweden in the SMART2D project

IntroductionType 2 diabetes (T2D) and its complications are increasing rapidly. Support for healthy lifestyle and self-management is paramount, but not adequately implemented in health systems. Process evaluations facilitate understanding why...