Promoting the health of vulnerable populations: Three steps towards a systems-based re-orientation of public health intervention research.

This paper proposes a novel framework for the development of interventions in vulnerable populations. The framework combines a complex systems lens with syndemic theory. Whereas funding bodies, research organizations and reporting guidelines tend to encourage intervention research that (i) focuses on singular and predefined health outcomes, (ii) searches for generalizable cause-effect relationships, and (iii) aims to identify universally effective interventions, the paper suggests that a different direction is needed for addressing health inequities: We need to (i) start with exploratory analysis of population-level data, and (ii) invest in contextualized in-depth knowledge of the complex dynamics that produce health inequities in specific populations and settings, while we (iii) work with stakeholders at multiple levels to create change within systems.

Early access to antiretroviral therapy versus standard of care among HIV-positive participants in Eswatini in the public health sector: the MaxART stepped-wedge randomized controlled trial.

INTRODUCTION: The WHO recommends antiretroviral treatment (ART) for all HIV-positive patients regardless of CD4 count or disease stage, referred to as "Early Access to ART for All" (EAAA). The health systems effects of EAAA implementation are unknown. This trial was implemented in a government-managed public health system with the aim to examine the "real world" impact of EAAA on care retention and viral suppression. METHODS: In this stepped-wedge randomized controlled trial, 14 public sector health facilities in Eswatini were paired and randomly assigned to stepwise transition from standard of care (SoC) to EAAA. ART-naïve participants ≥18 years who were not pregnant or breastfeeding were eligible for enrolment. We used Cox proportional hazard models with censoring at clinic transition to estimate the effects of EAAA on retention in care and retention and viral suppression combined. RESULTS: Between September 2014 and August 2017, 3405 participants were enrolled. In SoC and EAAA respectively, 12-month HIV care retention rates were 80% (95% CI: 77 to 83) and 86% (95% CI: 83 to 88). The 12-month combined retention and viral suppression endpoint rates were 44% (95% CI: 40 to 48) under SoC compared to 80% (95% CI: 77 to 83) under EAAA. EAAA increased both retention (HR: 1·60, 95% CI: 1·15 to 2·21, p = 0.005) and retention and viral suppression combined (HR: 4.88, 95% CI: 2.96 to 8.05, p < 0.001). We also identified significant gaps in current health systems ability to provide viral load (VL) monitoring with 80% participants in SoC and 66% in EAAA having a missing VL at last contact. CONCLUSIONS: The observed improvement in retention in care and on the combined retention and viral suppression provides an important co-benefit of EAAA to HIV-positive adults themselves, at least in the short term. Our results from this "real world" health systems trial strongly support EAAA for Eswatini and countries with similar HIV epidemics and health systems. VL monitoring needs to be scaled up for appropriate care management.

Care use and its intensity in children with complex problems are related to varying child and family factors: A follow-up study.

BACKGROUND: There is little evidence on the child and family factors that affect the intensity of care use by children with complex problems. We therefore wished to identify changes in these factors associated with changes in care service use and its intensity, for care use in general and psychosocial care in particular. METHODS: Parents of 272 children with problems in several life domains completed questionnaires at baseline (response 69.1%) and after 12 months. Negative binominal Hurdle analyses enabled us to distinguish between using care services (yes/ no) and its intensity, i.e. number of contacts when using care. RESULTS: Change in care use was more likely if the burden of adverse life events (ALE) decreased (odds ratio, OR = 0.94, 95% confidence interval, CI = 0.90-0.99) and if parenting concerns increased (OR = 1.29, CI = 1.11-1.51). Psychosocial care use became more likely for school-age children (vs. pre-school) (OR = 1.99, CI = 1.09-3.63) if ALE decreased (OR = 0.93, CI = 0.89-0.97) and if parenting concerns increased (OR = 1.26, CI = 1.10-1.45). Intensity of use (>0 contacts) of any care decreased when ALE decreased (relative risk, RR = 0.95, CI = 0.92-0.98) and when psychosocial problems became less severe (RR = 0.38, CI = 0.20-0.73). Intensity of psychosocial care also decreased when severe psychosocial problems became less severe (RR = 0.39, CI = 0.18-0.84). CONCLUSIONS: Changes in care-service use (vs. no use) and its intensity (>0 contacts) are explained by background characteristics and changes in a child's problems. Care use is related to factors other than changes in its intensity, indicating that care use and its intensity have different drivers. ALE in particular contribute to intensity of any care use.

Community resources support adherence to treatment for childhood cancer in El Salvador.

OBJECTIVE: In order to reduce nonadherence and treatment abandonment of children with cancer in El Salvador, institutions located nearby the patients' homes were involved to provide support. Methodological approach: Health clinics and municipality offices in the patients' communities were asked to assist families who were not promptly located after missing hospital appointments, or those whose financial limitations were likely to impede continuation of treatment. Data was collected about the number of contacted institutions, the nature of help provided, staff's time investments, and parents' perceptions about the intervention. FINDINGS: Local institutions (133 from 206 contacts) conducted home visits (83), and/or provided parents with money (55) or transportation (60). Parents found this support essential for continuing the treatment but they also encountered challenges regarding local institutions' inconsistencies. Nonadherence and abandonment decreased. IMPLICATIONS: Economic burden was reduced on both the families and the hospital. Involvement of external institutions might become regular practice to support families of children with cancer.

Improving access to school health services as perceived by school professionals.

BACKGROUND: The organisation of health assessments by preventive health services focusing on children's health and educational performance needs to be improved due to evolving health priorities such as mental health problems, reduced budgets and shortages of physicians and nurses. We studied the impact on the school professionals' perception of access to school health services (SHS) when a triage approach was used for population-based health assessments in primary schools. The triage approach involves pre-assessments by SHS assistants, with only those children in need of follow-up being assessed by a physician or nurse. The triage approach was compared with the usual approach in which all children are assessed by physicians and nurses. METHODS: We conducted a cross-sectional study, comparing school professionals' perceptions of the triage and the usual approach to SHS. The randomly selected school professionals completed digital questionnaires about contact frequency, the approachability of SHS and the appropriateness of support from SHS. School care coordinators and teachers were invited to participate in the study, resulting in a response of 444 (35.7%) professionals from schools working with the triage approach and 320 (44.6%) professionals working with the usual approach. RESULTS: Respondents from schools using the triage approach had more contacts with SHS and were more satisfied with the appropriateness of support from SHS than respondents in the approach-as-usual group. No significant differences were found between the two groups in terms of the perceived approachability of SHS. CONCLUSIONS: School professionals were more positive about access to SHS when a triage approach to routine assessments was in place than when the usual approach was used. Countries with similar population-based SHS systems could benefit from a triage approach which gives physicians and nurses more opportunities to attend schools for consultations and assessments of children on demand.

Impact of early initiation versus national standard of care of antiretroviral therapy in Swaziland's public sector health system: study protocol for a stepped-wedge randomized trial.

BACKGROUND: There is robust clinical evidence to support offering early access to antiretroviral treatment (ART) to all HIV-positive individuals, irrespective of disease stage, to both improve patient health outcomes and reduce HIV incidence. However, as the global treatment guidelines shift to meet this evidence, it is still largely unknown if early access to ART for all (also referred to as "treatment as prevention" or "universal test and treat") is a feasible intervention in the resource-limited countries where this approach could have the biggest impact on the course of the HIV epidemics. The MaxART Early Access to ART for All (EAAA) implementation study was designed to determine the feasibility, acceptability, clinical outcomes, affordability, and scalability of offering early antiretroviral treatment to all HIV-positive individuals in Swaziland's public sector health system. METHODS: This is a three-year stepped-wedge randomized design with open enrollment for all adults aged 18 years and older across 14 government-managed health facilities in Swaziland's Hhohho Region. Primary endpoints are retention and viral suppression. Secondary endpoints include ART initiation, adherence, drug resistance, tuberculosis, HIV disease progression, patient satisfaction, and cost per patient per year. Sites are grouped to transition two at a time from the control (standard of care) to intervention (EAAA) stage at each four-month step. This design will result in approximately one half of the total observation time to accrue in the intervention arm and the other half in the control arm. Our estimated enrolment number, which is supported by conservative power calculations, is 4501 patients over the course of the 36-month study period. A multidisciplinary, mixed-methods approach will be adopted to supplement the randomized controlled trial and meet the study aims. Additional study components include implementation science, social science, economic evaluation, and predictive HIV incidence modeling. DISCUSSION: A stepped-wedge randomized design is a causally strong and robust approach to determine if providing antiretroviral treatment for all HIV-positive individuals is a feasible intervention in a resource-limited, public sector health system. We expect our study results to contribute to health policy decisions related to the HIV response in Swaziland and other countries in sub-Saharan Africa. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02909218 . Registered on 10 July 2016.

Child mental health in Sierra Leone: a survey and exploratory qualitative study.

BACKGROUND: This study complements the growing amount of research on the psychosocial impact of war on children in Sierra Leone by examining local perceptions of child mental health, formal and informal care systems, help-seeking behaviour and stigma. METHODS: The study combined: (1) a nationwide survey of mental health care providers, with (2) exploratory qualitative research among service users and providers and other stakeholders concerned with child and adolescent mental health, with a particular emphasis on local explanations and stigma. RESULTS: Formal mental health care services are extremely limited resulting in an estimated treatment gap of over 99.8 %. Local explanations of child mental health problems in Sierra Leone are commonly spiritual or supernatural in nature, and associated with help-seeking from traditional healers or religious institutions. There is a considerable amount of stigma related to mental disorders, which affects children, their caregivers and service providers, and may lead to discrimination and abuse. CONCLUSIONS: Child and Adolescent Mental Health (CAMH) care development in Sierra Leone should cater to the long-term structural effects of war-violence and an Ebola epidemic. Priorities for development include: (1) the strengthening of legal structures and the development of relevant policies that strengthen the health system and specifically include children and adolescents, (2) a clearer local distinction between children with psychiatric, neurological, developmental or psychosocial problems and subsequent channelling into appropriate services (3) supplementary CAMH training for a range of professionals working with children across various sectors, (4) specialist training in CAMH, (5) integration of CAMH care into primary health care, education and the social welfare system, (6) further research on local explanations of child mental disorders and the effect they have on the well-being of the child, and (7) a careful consideration of the role of religious healers as care providers.

Deprescribing Potentially Inappropriate Preventive Cardiovascular Medication: Barriers and Enablers for Patients and General Practitioners.

BACKGROUND: The use of preventive cardiovascular medication by patients with low cardiovascular disease (CVD) risk is potentially inappropriate. OBJECTIVE: The aim of this study was to identify barriers to and enablers of deprescribing potentially inappropriate preventive cardiovascular medication experienced by patients and general practitioners (GPs). METHODS: A total of 10 GPs participating in the ECSTATIC trial (Evaluating Cessation of STatins and Antihypertensive Treatment In primary Care) audiotaped deprescribing consultations with low-CVD-risk patients. After initial conventional content analysis, 2 researchers separately coded all barriers to and enablers of deprescribing medication using framework analysis. We performed a within-case and cross-case analysis to explore barriers and enablers among both patients and GPs. RESULTS: Patients (n = 49) and GPs (n = 10) expressed barriers and enablers with regard to the appropriateness of the medication and the deprescribing process. A family history for CVD was identified as a barrier to deprescribing medication for both patients and GPs. Patients feared possible consequences of deprescribing and were influenced by the opinion of their GP. Additionally, a presumed disapproving opinion from specialists influenced the GPs' willingness to deprescribe medication. CONCLUSIONS: Patients appreciated discussing their doubts regarding deprescribing potentially inappropriate preventive cardiovascular medication. Furthermore, they acknowledged their GP's expertise and took their opinion toward deprescribing into consideration. The GPs' decisions to deprescribe were influenced by the low CVD risk of the patients, additional risk factors, and the alleged specialist's opinion toward deprescribing. We recommend deprescribing consultations to be patient centered, with GPs addressing relevant themes and probable consequences of deprescribing preventive cardiovascular medication.

Bioethics in practice: Addressing ethically sensitive requests in a Dutch fertility clinic.

This article provides insight into how ethically sensitive requests for the use of assisted reproductive technologies (ARTs) are dealt within the daily practice of a Dutch fertility clinic. The findings presented are part of an ethnographic study conducted in this clinic from September 2003 until April 2005. Information for this article was gathered by attending the multidisciplinary ethics meetings and conversations with clinic staff. By looking at 'bioethics in practice', this article provides insight into the complex and dynamic interplay between particular couples' situations, contextual features, bioethical principles, doctors' subjective feelings and views, and the employment of medical practices. Our study suggests that personal views to a certain extent inform the agenda of the ethics meetings, but in the end neither these views nor bioethical principles fully determine the decisions made. Clinic staff members employ routine medical practices with the intention to carefully resolve ethically sensitive cases. These practices include: collegial consultation, searching for scientific evidence in the literature, obtaining more medical information, offering medical tests, referring couples to other clinics and ensuring informed consent. Rather than examining hypothetical cases, which evoke principles, observations of practices regarding real life cases of which many details are known, allowed us to identify the influence of routine medical practice on ethical decisions. Despite initial concerns from the side of the medical professionals (some of which might be regarded as paternalistic), at the end the reproductive autonomy of most couples seeking ARTs was not jeopardized. The format of the multidisciplinary ethics meetings seems to be promising as it provides a space for clinic staff members to express and reflect on their subjective views and feelings of unease regarding certain requests for ARTs, while at the same time it diminishes the risk that decision making is (too heavily) shaped by these feelings and views.

The guardians' perspective on paediatric cancer treatment in Malawi and factors affecting adherence.

BACKGROUND: Abandonment of paediatric cancer treatment is a common problem in developing countries. Little is known about the guardians' perspective on cancer treatment in these countries, especially the factors that affect adherence. METHODS: Following a pilot study enquiring into the possible causes of abandonment, a problem analysis diagram was drawn which helped to develop the questionnaires. Semi-structured interviews (n = 83) and focus group discussions (n = 8) were held with the guardians of 25 Burkitt lymphoma patients and 7 Wilms tumour patients at different phases of therapy in Malawi. RESULTS: Parents in Malawi are very motivated to continue treatment if they think that it will cure their child. Financial costs are important concerns. Not all tasks at home are assumed by other household members. The diagnosis of cancer was unknown before being told about it in hospital and caused fear of recurrence and death. Guardians are reluctant to ask the health personnel questions. They worry that taking frequent blood samples will weaken their child. The side effects of the chemotherapy are seen as a proof of efficacy. CONCLUSION: It is important to appreciate the guardians' concerns when offering treatment that requires their sustained commitment. It is necessary to provide not only medical treatment, but also travel allowances and adequate nutritional support during long hospital stays to impoverished families. Information should be given proactively.