Contextual equipoise: a novel concept to inform ethical implications for implementation research in low-income and middle-income countries.

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.

Using a mentorship model to localise the Practical Approach to Care Kit (PACK): from South Africa to Ethiopia.

The Federal Ministry of Health, Ethiopia, recognised the potential of the Practical Approach to Care Kit (PACK) programme to promote integrated, comprehensive and evidence-informed primary care as a means to achieving universal health coverage. Localisation of the PACK guide to become the 'Ethiopian Primary Health Care Clinical Guidelines' (PHCG) was spearheaded by a core team of Ethiopian policy and technical experts, mentored by the Knowledge Translation Unit, University of Cape Town. A research collaboration, ASSET (heAlth Systems StrEngThening in sub-Saharan Africa), has brought together policy-makers from the Ministry of Health and health systems researchers from Ethiopia (Addis Ababa University) and overseas partners for the PACK localisation process, and will develop, implement and evaluate health systems strengthening interventions needed for a successful scale-up of the Ethiopian PHCG. Localisation of PACK for Ethiopia included expanding the guide to include a wider range of infectious diseases and an expanded age range (from 5 to 15 years). Early feedback from front-line primary healthcare (PHC) workers is positive: the guide gives them greater confidence and is easy to understand and use. A training cascade has been initiated, with a view to implementing in 400 PHC facilities in phase 1, followed by scale-up to all 3724 health centres in Ethiopia during 2019. Monitoring and evaluation of the Ministry of Health implementation at scale will be complemented by indepth evaluation by ASSET in demonstration districts. Anticipated challenges include availability of essential medications and laboratory investigations and the need for additional training and supervisory support to deliver care for non-communicable diseases and mental health. The strong leadership from the Ministry of Health of Ethiopia combined with a productive collaboration with health systems research partners can help to ensure that Ethiopian PHCG achieves standardisation of clinical practice at the primary care level and quality healthcare for all.

Feasibility and reliability of the elderly version of the Camberwell Assessment of Needs (CANE): results from the São Paulo Ageing & Health Study.

OBJECTIVE: We set out to assess the feasibility, reliability and convergent validity of the Camberwell Assessment of Needs for the Elderly Scale in older residents of a Brazilian urban elderly population of low socioeconomic status. METHOD: We identified 32 older users of community health services from a population-based catchment area survey. We administered the Brazilian version of the Camberwell Assessment of Needs for the Elderly Scale to the older person and to an informal caregiver, and tape-recorded the assessments. Interviewers made a rating. Tape-recordings were independently co-rated. RESULTS: Items contributing to older person and caregiver reports of needs and unmet needs had a high internal consistency. Inter-rater reliability was excellent for all needs, and fair to good for unmet needs. Older person and caregiver's reports, and interviewer ratings were highly mutually consistent. Convergent validity was supported by associations, as hypothesized, between needs and disability, and needs and dementia. CONCLUSIONS: The Brazilian version of the Camberwell Assessment of Needs for the Elderly Scale is a feasible, reliable and, to the extent assessed, valid assessment of unmet needs in a disadvantaged low and middle income countries setting. Its practical utility as a clinical tool remains to be assessed.

Feasibility and reliability of the elderly version of the Camberwell Assessment of Needs (CANE): results from the São Paulo Ageing & Health Study / Aplicabilidade e confiabilidade da versão para idosos da escala Camberwell de Avaliação de Necessidades (CANE): resultados do São Paulo Ageing & Health Study

OBJECTIVE: We set out to assess the feasibility, reliability and convergent validity of the Camberwell Assessment of Needs for the Elderly Scale in older residents of a Brazilian urban elderly population of low socioeconomic status. METHOD: We identified 32 older users of community health services from a population-based catchment area survey. We administered the Brazilian version of the Camberwell Assessment of Needs for the Elderly Scale to the older person and to an informal caregiver, and tape-recorded the assessments. Interviewers made a rating. Tape-recordings were independently co-rated. RESULTS: Items contributing to older person and caregiver reports of needs and unmet needs had a high internal consistency. Inter-rater reliability was excellent for all needs, and fair to good for unmet needs. Older person and caregiver's reports, and interviewer ratings were highly mutually consistent. Convergent validity was supported by associations, as hypothesized, between needs and disability, and needs and dementia. CONCLUSIONS: The Brazilian version of the Camberwell Assessment of Needs for the Elderly Scale is a feasible, reliable and, to the extent assessed, valid assessment of unmet needs in a disadvantaged low and middle income countries setting. Its practical utility as a clinical tool remains to be assessed.

OBJETIVO: O objetivo deste estudo foi o de avaliar a aplicabilidade, a confiabilidade e a validação convergente da Escala Camberwell de Avaliação de Necessidades em Idosos em uma população de baixa renda residente na cidade de São Paulo. MÉTODO: O estudo incluiu 32 participantes com 65 anos ou mais, usuários de serviços de saúde local que fizeram parte do estudo de levantamento de base populacional. A Escala Camberwell de Avaliação de Necessidades em Idosos foi administrada ao participante e ao seu cuidador, todas as entrevistas foram gravadas. Assistentes de pesquisa pontuaram as entrevistas. As gravações foram pontuadas por um pesquisador independente. RESULTADOS: Itens que contribuíram para a pontuação positiva de necessidades atendidas ou não atendidas pelos participantes e seus cuidadores obtiveram alto coeficientes de consistência interna. Confiabilidade entre examinadores foi excelente para todas as necessidades, e para necessidades não atendidas oscilou entre razoável e boa. As respostas de participantes e cuidadores, e as pontuações dos entrevistadores foram mutuamente consistentes. Validade convergente foi mantida pelas associações entre necessidades e incapacidade, e necessidades e demência. CONCLUSÕES: O estudo de confiabilidade da versão brasileira da Escala Camberwell de Avaliação de Necessidades em Idosos mostrou que a mesma é um instrumento de pesquisa prático, confiável e válido para avaliar necessidades em países em desenvolvimento menos favorecidos.

Mother-child joint activity and behaviour problems of pre-school children.

BACKGROUND: Behaviour problems are common among pre-school children, and a substantial proportion persist, causing significant burden to the family, schools and health services. Relatively little research has addressed the effects of positive parenting on behaviour disorder in pre-school children, particularly in larger population-based studies. METHOD: A cross-sectional postal survey of a representative, population-based sample of 800 mothers of 3 1/2-year-old children living in an outer London Borough was carried out to assess the association between mother-child joint activity and behaviour problems of pre-school children. The response rate was 70%. RESULTS: Lower levels of mother-child joint activity remained independently associated with behaviour problems of pre-school children both on a binary and a continuous scale after adjusting for a wide range of household, maternal and child circumstances. The association between low levels of mother-child joint activities and behaviour problems of the children was stronger in the presence of social problems in the family. CONCLUSION: Possible causal pathways and directions for future research and intervention are discussed.