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[This corrects the article DOI: 10.1371/journal.pone.0272077.]. Copyright: © 2023 Szlamka et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

There are increasing efforts to scale up services globally for families raising children with developmental disabilities (DDs). Existing interventions, often developed in high income, Western settings, need substantial adaptation before they can be implemented in different contexts. The aim of this study was to explore perspectives on the role that context plays in the adaptation and implementation of interventions targeting caregivers of children with DDs across settings. The study question was applied to the Caregiver Skills Training (CST) programme of the World Health Organization specifically, as well as to stakeholder experiences with caregiver interventions more broadly. Two focus group discussions (FGDs; n = 15 participants) and 25 individual semi-structured interviews were conducted. Participants were caregivers of children with DDs and professionals involved in adapting or implementing the CST across five continents and different income settings. Data were analysed thematically. Four main themes were developed: 1) Setting the scene for adaptations; 2) Integrating an intervention into local public services; 3) Understanding the reality of caregivers; 4) Challenges of sustaining an intervention. Informants thought that contextual adaptations were key for the intervention to fit in locally, even more so than cultural factors. The socio-economic context of caregivers, including poverty, was highlighted as heavily affecting service access and engagement with the intervention. Competing health priorities other than DDs, financial constraints, and management of long-term collaborations were identified as barriers. This study validates the notion that attention to contextual factors is an essential part of the adaptation of caregiver interventions for children with DDs, by providing perspectives from different geographical regions. We recommend a stronger policy and research focus on contextual adaptations of interventions and addressing unmet socio-economic needs

OBJECTIVE: To explore hospital-level care for pre-eclampsia in Ethiopia, considering the perspectives of those affected and healthcare providers, in order to understand barriers and facilitators to early detection, care escalation and appropriate management. SETTING: A primary and a general hospital in southern Ethiopia. PARTICIPANTS: Women with lived experience of pre-eclampsia care in the hospital, families of women deceased due to pre-eclampsia, midwives, doctors, integrated emergency surgical officers and healthcare managers. RESULTS: This study identified numerous systemic barriers to provision of quality, person-centred care for pre-eclampsia in hospitals. Individual staff efforts to respond to maternal emergencies were undermined by a lack of consistency in availability of resources and support. The ways in which policies were applied exacerbated inequities in care. Staff improvised as a means of managing with limited material or human resources and knowledge. Social hierarchies and punitive cultures challenged adequacy of communication with women, documentation of care given and supportive environments for quality improvement. CONCLUSIONS: Quality care for pre-eclampsia requires organisational change to create a safe space for learning and improvement, alongside efforts to offer patient-centred care and ensure providers are equipped with knowledge, resources and support to adhere to evidence-based practice.

Background: The available care for people with psychosis in South Africa is inadequate to support personal recovery. Group peer support interventions are a promising approach to foster recovery, but little is known about the preferences of service users, or the practical application of this care model, in low- and middle-income countries (LMIC). This study aims to assess the acceptability and feasibility of integrating peer-led recovery groups for people with psychosis and their caregivers in South Africa into existing systems of care, and to determine key parameters in preparation for a definitive trial. Methods: The study is set in Nelson Mandela Bay Metropolitan district of the Eastern Cape Province, South Africa. The design is an individually randomised parallel group feasibility trial comparing recovery groups in addition to treatment as usual (TAU) with TAU alone in a 1:1 allocation ratio. We aim to recruit 100 isiXhosa-speaking people with psychosis and 100 linked caregivers. TAU comprises anti-psychotic medication-focused outpatient care. The intervention arm will comprise seven recovery groups, including service users and caregiver participants. Recovery groups will be delivered in two phases: a 2-month phase facilitated by an auxiliary social worker, then a 3-month peer-led phase. We will use mixed methods to evaluate the process and outcomes of the study. Intervention acceptability and feasibility (primary outcomes) will be assessed at 5 months post-intervention start using qualitative data collected from service users, caregivers, and auxiliary social workers, along with quantitative process indicators. Facilitator competence will be assessed with the GroupACT observational rating tool. Trial procedures will be assessed, including recruitment and retention rates, contamination, and validity of quantitative outcome measures. To explore potential effectiveness, quantitative outcome data (functioning, unmet needs, personal recovery, internalised stigma, hea

To achieve universal health coverage, health system strengthening (HSS) is required to support the of delivery of high-quality care. The aim of the National Institute for Health Research Global Research Unit on HeAlth System StrEngThening in Sub-Saharan Africa (ASSET) is to address this need in a four-year programme, with three healthcare platforms involving eight work-packages. Key to effective health system strengthening (HSS) is the pre-implementation phase of research where efforts focus on applying participatory methods to embed the research programme within the existing health system. To conceptualise the approach, we provide an overview of the key methods applied across work-package to address this important phase of research conducted between 2017 and 2021.Work-packages are being undertaken in publicly funded health systems in rural and urban areas in Ethiopia, Sierra Leone, South Africa, and Zimbabwe. Stakeholders including patients and their caregivers, community representatives, clinicians, managers, administrators, and policymakers are the main research participants.In each work-package, initial activities engage stakeholders and build relationships to ensure co-production and ownership of HSSIs. A mixed-methods approach is then applied to understand and address determinants of high-quality care delivery. Methods such as situation analysis, cross-sectional surveys, interviews and focus group discussions are adopted to each work-package aim and context. At the end of the pre-implementation phase, findings are disseminated using focus group discussions and participatory Theory of Change workshops where stakeholders from each work package use findings to select HSSIs and develop a programme theory.ASSET places a strong emphasis of the pre-implementation phase in order to provide an in-depth and systematic diagnosis of the existing heath system functioning, needs for strengthening and stakeholder engagement. This common approach will inform the design and ev

Pre-eclampsia, a complex and multi-system disorder specific to pregnancy, is a leading cause of preventable maternal and perinatal deaths in low-resource settings. Early detection and appropriate intervention with management of hypertension, prevention of eclampsia and timely delivery are effective at reducing mortality and morbidity. Outcomes can be greatly improved with the provision and uptake of good quality care. Cultural contexts of maternal care, social practices and expectations around pregnancy and childbirth profoundly shape understanding and prioritisation when it comes to seeking out care. Few studies have addressed health education specifically targeting pre-eclampsia in low resource settings. The existing literature has limited descriptions of contextual barriers to care or of the intervention development processes employed. More engaging, holistic approaches to pre-eclampsia education for women and families that recognise the challenges they face and that support a shared understanding of the disorder, are needed. We describe our experience of developing a Theory of Change (ToC) as part of the co-production of educational resources for pre-eclampsia in Haiti and Zimbabwe.

Background: Evidence-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. Methods: We 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. Results: In 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 m

Acute services for mental health crises are very important to service users and their supporters, and consume a substantial share of mental health resources in many countries. However, acute care is often unpopular and sometimes coercive, and the evidence on which models are best for patient experience and outcomes remains surprisingly limited, in part reflecting challenges in conducting studies with people in crisis. Evidence on best ap-proaches to initial assessment and immediate management is particularly lacking, but some innovative models involving extended assessment, brief interventions, and diversifying settings and strategies for providing support are potentially helpful. Acute wards continue to be central in the intensive treatment phase following a crisis, but new approaches need to be developed, evaluated and implemented to reducing coercion, addressing trauma, diversifying treatments and the inpatient workforce, and making decision-making and care collaborative. Intensive home treatment services, acute day units, and community crisis services have supporting evidence in diverting some service users from hospital admission: a greater understanding of how best to implement them in a wide range of contexts and what works best for which service users would be valuable. Approaches to crisis management in the voluntary sector are more flexible and informal: such services have potential to complement and provide valuable learning for statutory sector services, especially for groups who tend to be underserved or disengaged. Such approaches often involve staff with personal experience of mental health crises, who have important potential roles in improving quality of acute care across sectors. Large gaps exist in many low- and middle-income countries, fuelled by poor access to quality mental health care. Responses need to build on a foundation of existing community responses and contextually relevant evidence. The necessity of moving outside formal systems in lo

Implementation research is a multidisciplinary field that addresses the complex phenomenon of how context influences our ability to deliver evidence-informed healthcare. There is increasing realisation of the importance of applying robust implementation research to scale-up life-saving interventions that meet health-related sustainable development goals. However, the lack of high-quality implementation research is impeding our ability to meet these targets, globally. Within implementation research, theory refers to the proposed hypothesis and/or explanation of how an intervention is expected to interact with the local context and actors to bring about change. Although there is increasing interest in applying theory to understand how and why implementation programmes work in real-world settings, global health actors still tend to favour impact evaluations conducted in controlled environments. This may, in part, be due to the relative novelty as well as methodological complexity of implementation research and the need to draw on divergent disciplines, including epidemiology, implementation science and social sciences. Because of this, implementation research is faced with a particular set of challenges about how to reconcile different ways of thinking and constructing knowledge about healthcare interventions. To help translate some of the ambiguity surrounding how divergent theoretical approaches and methods contribute to implementation research, we draw on our multidisciplinary expertise in the field, particularly in global health. We offer an overview of the different theoretical approaches and describe how they are applied to continuously select, monitor and evaluate implementation strategies throughout the different phases of implementation research. In doing so, we offer a relatively brief, user-focused guide to help global health actors implement and report on evaluation of evidence-based and scalable interventions, programmes and practices.

OBJECTIVES: ASSET (Health System Strengthening in sub-Saharan Africa) is a health system strengthening (HSS) programme involving eight work-packages (ie, a research study that addresses a specific need for HSS) that aims to develop solutions that support high-quality care. Here we present the protocol for the implementation science (IS) theme within ASSET (ASSET-ImplmentER) that aims to understand what HSS interventions work, for whom and how, and how IS methodologies can be adapted to improve the HSS interventions within resource-poor contexts. SETTINGS: Publicly funded health facilities in rural and urban areas in in Ethiopia, South Africa, Sierra Leone, and Zimbabwe. PARTICIPANTS: Research staff including principal investigators, coinvestigators, field staff, PhD students, and research assistants. INTERVENTIONS: Work-packages use a mixed-methods effectiveness-effectiveness hybrid designs. At the end of the pre-implementation phase, a workshop is held whereby the IS theme, jointly with ASSET work-packages apply IS determinant frameworks to research findings to identify factors that influence the effectiveness of delivering evidence-informed care. Determinants are used to select a set of HSS interventions for further evaluation, where work-packages also theorise selective mechanisms.In the piloting and rolling implementation phase, work-packages pilot the HSS interventions. An iterative process then begins involving evaluation, reflection and adaptation. Throughout this phase, IS determinant frameworks are applied to monitor and identify barriers/enablers to implementation. Selective mechanisms of action are also investigated. Implementation outcomes are evaluated using qualitative and quantitative methods. The psychometric properties of outcome measures including acceptability, appropriateness and feasibility are also evaluated. In a final workshop, work-packages come together, to reflect and explore the utility of the selected IS methods and provide suggestions f

Background: Despite a high prevalence of antenatal depression in low- and middle-income countries, there is very little evidence for contextually adapted psychological interventions delivered in rural African settings. The aims of this study are (1) to examine the feasibility of procedures for a future fully powered efficacy trial of contextually adapted brief problem solving therapy (PST) for antenatal depression in rural Ethiopia, and (2) to investigate the acceptability, fidelity and feasibility of delivery of PST in routine antenatal care. Methods: Design: A randomised, controlled, feasibility trial and mixed method process evaluation. Participants: Consecutive women attending antenatal clinics in two primary care facilities in rural Ethiopian districts. Eligibility criteria: (1) disabling levels of depressive symptoms (Patient Health Questionnaire (PHQ-9) score of five or more and positive for the 10th disability item); (2) gestational age 12–34 weeks; (3) aged 16 years and above; (4) planning to live in the study area for at least 6 months; (5) no severe medical or psychiatric conditions. Intervention: Four sessions of adapted PST delivered by trained and supervised antenatal care staff over a maximum period of eight weeks. Control: enhanced usual care (EUC). Sample size: n = 50. Randomisation: individual randomisation stratified by intimate partner violence (IPV). Allocation: central phone allocation. Outcome assessors and statistician masked to allocation status. Primary feasibility trial outcome: dropout rate. Primary future efficacy trial outcome: change in PHQ-9 score, assessed 9 weeks after recruitment. Secondary outcomes: anxiety symptoms, trauma symptoms, intimate partner violence, disability, healthcare costs at 9 weeks; postnatal outcomes (perinatal and neonatal complications, onset of breast feeding, child health) assessed 4–6 weeks postnatal. Other trial feasibility indicators: recruitment, number and duration of sessions attended. Audio-recording

BACKGROUND: Pre-eclampsia is a leading cause of preventable maternal and perinatal deaths globally. While health inequities remain stark, removing financial or structural barriers to care does not necessarily improve uptake of life-saving treatment. Building on existing literature elaborating the sociocultural contexts that shape behaviours around pregnancy and childbirth can identify nuanced influences relating to pre-eclampsia care. METHODS: We conducted a cross-cultural comparative study exploring lived experiences and understanding of pre-eclampsia in Ethiopia, Haiti and Zimbabwe. Our primary objective was to examine what local understandings of pre-eclampsia might be shared between these three under-resourced settings despite their considerable sociocultural differences. Between August 2018 and January 2020, we conducted 89 in-depth interviews with individuals and 17 focus group discussions (n = 106). We purposively sampled perinatal women, survivors of pre-eclampsia, families of deceased women, partners, older male and female decision-makers, traditional birth attendants, religious and traditional healers, community health workers and facility-based health professionals. Template analysis was conducted to facilitate cross-country comparison drawing on Social Learning Theory and the Health Belief Model. RESULTS: Survivors of pre-eclampsia spoke of their uncertainty regarding symptoms and diagnosis. A lack of shared language challenged coherence in interpretations of illness related to pre-eclampsia. Across settings, raised blood pressure in pregnancy was often attributed to psychosocial distress and dietary factors, and eclampsia linked to spiritual manifestations. Pluralistic care was driven by attribution of causes, social norms and expectations relating to alternative care and trust in biomedicine across all three settings. Divergence across the contexts centred around nuances in religious or traditional practices relating to maternal health and pregnancy. C

The call for universal health coverage requires the urgent implementation and scale-up of interventions that are known to be effective, in resource-poor settings. Achieving this objective requires high-quality implementation research (IR) that evaluates the complex phenomenon of the influence of context on the ability to effectively deliver evidence-based practice. Nevertheless, IR for global health is failing to apply a robust, theoretically driven approach, leading to ethical concerns associated with research that is not methodologically sound.Inappropriate methods are often used in IR to address and report on context. This may result in a lack in understanding of how to effectively adapt the intervention to the new setting and a lack of clarity in conceptualising whether there is sufficient evidence to generalise findings from previous IR to a new setting, or if a randomised controlled trial (RCT) is needed. Some of the ethical issues arising from this shortcoming include poor-quality research that may needlessly expose vulnerable participants to research that has not been adapted to suit local needs and priorities, and the inappropriate use of RCTs that denies participants in the control arm access to treatment that is effective within the local context.To address these concerns, we propose a complementary approach to clinical equipoise for IR, known as contextual equipoise We discuss challenges in the evaluation of context and also with assessing the certainty of evidence to justify an RCT. Finally, we describe methods that can be applied to improve the evaluation and reporting of context and to help understand if contextual equipoise can be justified or if significant adaptations are required. We hope our analysis offers helpful insight to better understand and ensure that the ethical principle of beneficence is upheld in the real-world contexts of IR in low-resource settings.

BACKGROUND: In rural Ethiopia, 72% of women are exposed to lifetime intimate partner violence (IPV); IPV is most prevalent during pregnancy. As well as adversely affecting women's physical and mental health, IPV also increases the risk of child morbidity and mortality associated with maternal depression, thus making antenatal care an important opportunity for intervention. Adapting generic, task-shared, brief psychological interventions for perinatal depression and anxiety to address the needs and experiences of women affected by IPV may improve acceptability to women and feasibility for health workers. This randomised controlled feasibility trial will compare brief problem solving therapy (PST) specifically adapted for pregnant women experiencing IPV (PST-IPV) with standard PST and enhanced usual care to determine the feasibility of a future fully powered randomised controlled trial. METHODS: Seventy-five pregnant women scoring five or more on the Patient Health Questionnaire, endorsing a tenth question about functional impact and reporting past-year IPV, will be recruited from antenatal care clinics in predominantly rural districts in Ethiopia. Consenting participants will be randomised to either four sessions of PST-IPV, four sessions of standard PST or information about sources of support (enhanced usual care) in a three-arm design. The interventions will be delivered by trained, supervised antenatal care staff using a task-sharing model. Assessments will be made at baseline and after 9 weeks by masked outcome assessors and will include measures of depression symptoms (primary outcome), post-traumatic stress, anxiety symptoms, functional impact, past-month IPV and hypothesised mediators (secondary outcomes). A mixed-method process evaluation will determine the feasibility of a future randomised controlled trial, assess the feasibility, acceptability, fidelity and quality of implementation of PST-IPV, generate testable hypotheses about causal mechanisms, and iden

© 2019, © 2019 Informa UK Limited, trading as Taylor & Francis Group. Women’s professional team sport leagues have experienced a dramatic increase, yet research exploring the employment conditions and the perspectives the players involved is relatively sparse. The commencement of an inaugural rugby league competition for women in Australia and New Zealand provided a unique research opportunity to explore physical, sociocultural and organizational conditions and requirements of women athletes, and to identify inclusive management strategies and policies. Forty-nine perspective players for the professional competition were interviewed about their views on the transition of the women’s game from amateur to professional status and the associated management considerations. Two aggregate themes emerged from the interview data analysis: Gender identity and Institutional practice. The interview findings, together with an analysis of other women’s professional team sport enterprise agreements, informed decision making about the league’s size, duration and individual contract inclusions. Further implications for practice and future research are discussed.

The World Health Organization’s Caregiver Skills Training programme for children with developmental disorders or delays teaches caregivers strategies to help them support their child’s development. Ethiopia has a severe lack of services for children with developmental disorders or delays. This study explored the perspectives of Ethiopian caregivers, professionals and other stakeholders to inform adaptation and implementation of the World Health Organization’s Caregiver Skills Training in Ethiopia. Data collection included (1) a consultation and review, comprising stakeholder meetings, review of draft Caregiver Skills Training materials and feedback from Ethiopian Master Trainees and (2) a pre-pilot including quantitative feasibility and acceptability measures and qualitative interviews with caregivers (n = 9) and programme facilitators/observers (n = 5). The consultation participants indicated that the Caregiver Skills Training addresses an urgent need and is relevant to the Ethiopian context. Several adaptations were proposed, including more emphasis on psycho-education, stigma, parental feelings of guilt and expectations of a cure. The adapted Caregiver Skills Training was pre-piloted with excellent participation (100%) and retention (90%) rates. Four themes were developed from the qualitative data: (1) Programme acceptability and relevance, (2) Perceived programme benefits, (3) Challenges and barriers and (4) Suggestions for improvement. The World Health Organization’s Caregiver Skills Training addresses a local need and, with careful adaptations, is feasible and acceptable to be implemented in Ethiopia. These findings may have relevance to low-resource settings worldwide.

Background: Psychological interventions for antenatal depression are an integral part of evidence-based care but need to be contextualised for respective sociocultural settings. In this study, we aimed to understand women and healthcare workers' (HCWs) perspectives of antenatal depression, their treatment preferences and potential acceptability and feasibility of psychological interventions in the rural Ethiopian context. Methods: In-depth interviews were conducted with women who had previously scored above the locally validated cut-off (five or more) on the Patient Health Questionnaire during pregnancy (n = 8), primary healthcare workers (HCWs; nurses, midwives and health officers) (n = 8) and community-based health extension workers (n = 7). Translated interview transcripts were analysed using thematic analysis. Results: Women expressed their distress largely through somatic complaints, such as a headache and feeling weak. Facility and community-based HCWs suspected antenatal depression when women reported reduced appetite, sleep problems, difficulty bonding with the baby, or if they refused to breast-feed or were poorly engaged with antenatal care. Both women and HCWs perceived depression as a reaction ("thinking too much") to social adversities such as poverty, marital conflict, perinatal complications and losses. Depressive symptoms and social adversities were often attributed to spiritual causes. Women awaited God's will in isolation at home or talked to neighbours as coping mechanisms. HCWs' motivation to provide help, the availability of integrated primary mental health care and a culture among women of seeking advice were potential facilitators for acceptability of a psychological intervention. Fears of being seen publicly during pregnancy, domestic and farm workload and staff shortages in primary healthcare were potential barriers to acceptability of the intervention. Antenatal care providers such as midwives were considered best placed to deliver interven

Objective: Previous guidelines and planning documents have identified the key role primary care providers play in delivering mental health care, including the recommendation from the WHO that meeting the mental health needs of the population in many low and middle income countries will only be achieved through greater integration of mental health services within general medical settings. This position paper aims to build upon this work and present a global framework for enhancing mental health care delivered within primary care.Methods: This paper synthesizes previous guidelines, empirical data from the literature and experiences of the authors in varied clinical settings to identify core principles and the key elements of successful collaboration, and organizes these into practical guidelines that can be adapted to any setting.Results: The paper proposes a three-step approach. The first is mental health services that any primary care provider can deliver with or without the presence of a mental health professional. Second is practical ways that effective collaboration can enhance this care. The third looks at wider system changes required to support these new roles and how better collaboration can lead to new responses to respond to challenges facing all mental health systems.Conclusions: This simple framework can be applied in any jurisdiction or country to enhance the detection, treatment, and prevention of mental health problems, reinforcing the role of the primary care provider in delivering care and showing how collaborative care can lead to better outcomes for people with mental health and addiction problems.

There is growing interest in non-invasive brain stimulation (NIBS) as a novel treatment option for substance-use disorders (SUDs). Recent momentum stems from a foundation of preclinical neuroscience demonstrating links between neural circuits and drug consuming behavior, as well as recent FDA-approval of NIBS treatments for mental health disorders that share overlapping pathology with SUDs. As with any emerging field, enthusiasm must be tempered by reason; lessons learned from the past should be prudently applied to future therapies. Here, an international ensemble of experts provides an overview of the state of transcranial-electrical (tES) and transcranial-magnetic (TMS) stimulation applied in SUDs. This consensus paper provides a systematic literature review on published data – emphasizing the heterogeneity of methods and outcome measures while suggesting strategies to help bridge knowledge gaps. The goal of this effort is to provide the community with guidelines for best practices in tES/TMS SUD research. We hope this will accelerate the speed at which the community translates basic neuroscience into advanced neuromodulation tools for clinical practice in addiction medicine.