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The randomized controlled trial has become the standard basis for the evaluation of new therapeutic agents and procedures (and for measuring the protective efficacy of new vaccines or for assessing the value of screening procedures). Patients, who have met the criteria for eligibility and have agreed to participate in the trial, are allocated on a random basis to the alternative therapies under consideration. In order to avoid possible bias in the handling or assessment of these groups, a double blind procedure is preferred; the therapy given is not known to those who administer it, to those who assess the course of the disease thereafter, nor to the patients themselves. There is an extensive literature on clinical trials covering their logic and history, modern developments and the many complex, often controversial, issues that such trials have provoked. Not all issues have been fully resolved but by and large the principle, the practice and the ethical concerns of clinical trials are worked out and firmly established.

Abstract Background Male involvement in various health practices is recognized as an important factor in improving maternal and child health outcomes. Male involvement interventions involve men in a variety of ways, at varying levels of inclusion and use a range of outcome measures. There is little agreement on how male involvement should be measured and some authors contend that male involvement may actually be detrimental to women's empowerment and autonomy. Few studies explore the realities, perceptions, determinants and efficacy of male involvement in newborn care, especially in African contexts. Methods Birth narratives of recent mothers (n = 25), in-depth interviews with recent fathers (n = 12) and two focus group discussions with fathers (n = 22) were conducted during the formative research phase of a community-based newborn care trial. Secondary analysis of this qualitative data identified emergent themes and established overall associations related to male involvement, newborn care and household roles in a rural African setting. Results Data revealed that gender dictates many of the perceptions and politics surrounding newborn care in this context. The influence of mother-in-laws and generational power dynamics were also identified as significant. Women alone perform almost all tasks related to newborn care whereas men take on the traditional responsibilities of economic providers and decision makers, especially concerning their wives' and children's health. Most men were interested in being more involved in newborn care but identified barriers to increased involvement, many of which related to gendered and generational divisions of labour and space. Conclusions Men defined involvement in a variety of ways, even if they were not physically involved in carrying out newborn care tasks. Some participant comments revealed potential risks of increasing male involvement suggesting that male involvement alone should not be an outcome in future interventions. Rather, the effect of male involvement on women's autonomy, the dynamics of senior women's influence and power and the real impact on health outcomes should be considered in intervention design and implementation. Any male involvement intervention should integrate a detailed understanding of context and strategies to include men in maternal and child health should be mutually empowering for both women and men.

BACKGROUND: Male involvement in various health practices is recognized as an important factor in improving maternal and child health outcomes. Male involvement interventions involve men in a variety of ways, at varying levels of inclusion and use a range of outcome measures. There is little agreement on how male involvement should be measured and some authors contend that male involvement may actually be detrimental to women's empowerment and autonomy. Few studies explore the realities, perceptions, determinants and efficacy of male involvement in newborn care, especially in African contexts. METHODS: Birth narratives of recent mothers (n = 25), in-depth interviews with recent fathers (n = 12) and two focus group discussions with fathers (n = 22) were conducted during the formative research phase of a community-based newborn care trial. Secondary analysis of this qualitative data identified emergent themes and established overall associations related to male involvement, newborn care and household roles in a rural African setting. RESULTS: Data revealed that gender dictates many of the perceptions and politics surrounding newborn care in this context. The influence of mother-in-laws and generational power dynamics were also identified as significant. Women alone perform almost all tasks related to newborn care whereas men take on the traditional responsibilities of economic providers and decision makers, especially concerning their wives' and children's health. Most men were interested in being more involved in newborn care but identified barriers to increased involvement, many of which related to gendered and generational divisions of labour and space. CONCLUSIONS: Men defined involvement in a variety of ways, even if they were not physically involved in carrying out newborn care tasks. Some participant comments revealed potential risks of increasing male involvement suggesting that male involvement alone should not be an outcome in future interventions. Rather, the effect of male involvement on women's autonomy, the dynamics of senior women's influence and power and the real impact on health outcomes should be considered in intervention design and implementation. Any male involvement intervention should integrate a detailed understanding of context and strategies to include men in maternal and child health should be mutually empowering for both women and men.

Introduction: The early years are critical. Early nurturing care can lay the foundation for human capital accumulation with lifelong benefits. Conversely, early adversity undermines brain development, learning and future earning.Slums are among the most challenging places to spend those early years and are difficult places to care for a child. Shifting family and work structures mean that paid, largely informal, childcare seems to be becoming the 'new normal' for many preschool children growing up in rapidly urbanising Africa. However, little is known about the quality of this childcare. Aims: To build a rigorous understanding what childcare strategies are used and why in a typical Nairobi slum, with a particular focus on provision and quality of paid childcare. Through this, to inform evaluation of quality and design and implementation of interventions with the potential to reach some of the most vulnerable children at the most critical time in the life course. Methods and analysis: Mixed methods will be employed. Qualitative research (in-depth interviews and focus group discussions) with parents/carers will explore need for and decision-making about childcare. A household survey (of 480 households) will estimate the use of different childcare strategies by parents/carers and associated parent/carer characteristics. Subsequently, childcare providers will be mapped and surveyed to document and assess quality of current paid childcare. Semistructured observations will augment self-reported quality with observable characteristics/practices. Finally, in-depth interviews and focus group discussions with childcare providers will explore their behaviours and motivations. Qualitative data will be analysed through thematic analysis and triangulation across methods. Quantitative and spatial data will be analysed through epidemiological methods (random effects regression modelling and spatial statistics). Ethics and dissemination: Ethical approval has been granted in the UK and Kenya. Findings will be disseminated through journal publications, community and government stakeholder workshops, policy briefs and social media content.

BACKGROUND AND OBJECTIVE: Common mental disorders (CMD) are a leading global burden of disease. Up to 30% of primary care attenders suffer from these disorders but most do not receive evidence-based drug or psychological treatments. There are no trials of interventions which attempt to integrate these treatments into routine primary care in developing countries. The aims of this trial (the MANAS Project) are to evaluate the clinical and cost-effectiveness of a collaborative stepped-care intervention for the treatment of CMD in India. STUDY DESIGN: A cluster randomized controlled trial will be implemented in the state of Goa, on the west coast of India. Twenty-four primary care facilities, 12 from the government sector and 12 from the private sector, will be enrolled in two consecutive phases. For each sector, facilities will be randomly allocated within strata defined by urban/rural location, population size and presence of a visiting psychiatrist. Facilities will be randomly allocated to receive the collaborative stepped care intervention or the enhanced usual care control intervention. Both arms share two components of the intervention, viz., routine screening, and in the government clinics provision of antidepressants. In addition, the collaborative stepped care arm also provides a range of psychosocial treatments delivered by a specially trained Health Counselor, and supervision by a visiting Psychiatrist. A total of 3600 primary care attenders who are detected to suffer from a CMD based on a validated screening questionnaire will be recruited. The primary outcome is the proportion of subjects who recover from an ICD10 defined CMD at baseline by 6 months. Additional endpoints at 2 and 12 months will assess the speed and sustainability of achieving the primary outcomes. Other outcomes will include recovery from ICD10 defined depression and incidence of ICD-10 among individuals who were sub-threshold cases at baseline. Economic and disability outcomes will be assessed to estimate incremental cost-effectiveness ratios. IMPLICATIONS: This will be the first trial of the effectiveness of a complex intervention aiming to integrate efficacious treatments for CMD into routine primary care in a developing country. If effective, its findings will have relevance to policy makers who wish to scale up treatments for CMD in primary care across the world, but mostly in those countries where specialist mental health services are few. STUDY REGISTRATION: The MANAS project is registered through the National Institutes of Health sponsored clinical trials registry and has been assigned the identifier: NCT00446407.

BACKGROUND: Mobile health (mHealth) describes the use of portable electronic devices with software applications to provide health services and manage patient information. With approximately 5 billion mobile phone users globally, opportunities for mobile technologies to play a formal role in health services, particularly in low- and middle-income countries, are increasingly being recognized. mHealth can also support the performance of health care workers by the dissemination of clinical updates, learning materials, and reminders, particularly in underserved rural locations in low- and middle-income countries where community health workers deliver integrated community case management to children sick with diarrhea, pneumonia, and malaria. OBJECTIVE: Our aim was to conduct a thematic review of how mHealth projects have approached the intersection of cellular technology and public health in low- and middle-income countries and identify the promising practices and experiences learned, as well as novel and innovative approaches of how mHealth can support community health workers. METHODS: In this review, 6 themes of mHealth initiatives were examined using information from peer-reviewed journals, websites, and key reports. Primary mHealth technologies reviewed included mobile phones, personal digital assistants (PDAs) and smartphones, patient monitoring devices, and mobile telemedicine devices. We examined how these tools could be used for education and awareness, data access, and for strengthening health information systems. We also considered how mHealth may support patient monitoring, clinical decision making, and tracking of drugs and supplies. Lessons from mHealth trials and studies were summarized, focusing on low- and middle-income countries and community health workers. RESULTS: The review revealed that there are very few formal outcome evaluations of mHealth in low-income countries. Although there is vast documentation of project process evaluations, there are few studies demonstrating an impact on clinical outcomes. There is also a lack of mHealth applications and services operating at scale in low- and middle-income countries. The most commonly documented use of mHealth was 1-way text-message and phone reminders to encourage follow-up appointments, healthy behaviors, and data gathering. Innovative mHealth applications for community health workers include the use of mobile phones as job aides, clinical decision support tools, and for data submission and instant feedback on performance. CONCLUSIONS: With partnerships forming between governments, technologists, non-governmental organizations, academia, and industry, there is great potential to improve health services delivery by using mHealth in low- and middle-income countries. As with many other health improvement projects, a key challenge is moving mHealth approaches from pilot projects to national scalable programs while properly engaging health workers and communities in the process. By harnessing the increasing presence of mobile phones among diverse populations, there is promising evidence to suggest that mHealth can be used to deliver increased and enhanced health care services to individuals and communities, while helping to strengthen health systems.

India, with a population of more than 1 billion people, has many challenges in improving the health and nutrition of its citizens. Steady declines have been noted in fertility, maternal, infant and child mortalities, and the prevalence of severe manifestations of nutritional deficiencies, but the pace has been slow and falls short of national and Millennium Development Goal targets. The likely explanations include social inequities, disparities in health systems between and within states, and consequences of urbanisation and demographic transition. In 2005, India embarked on the National Rural Health Mission, an extraordinary effort to strengthen the health systems. However, coverage of priority interventions remains insufficient, and the content and quality of existing interventions are suboptimum. Substantial unmet need for contraception remains, adolescent pregnancies are common, and access to safe abortion is inadequate. Increases in the numbers of deliveries in institutions have not been matched by improvements in the quality of intrapartum and neonatal care. Infants and young children do not get the health care they need; access to effective treatment for neonatal illness, diarrhoea, and pneumonia shows little improvement; and the coverage of nutrition programmes is inadequate. Absence of well functioning health systems is indicated by the inadequacies related to planning, financing, human resources, infrastructure, supply systems, governance, information, and monitoring. We provide a case for transformation of health systems through effective stewardship, decentralised planning in districts, a reasoned approach to financing that affects demand for health care, a campaign to create awareness and change health and nutrition behaviour, and revision of programmes for child nutrition on the basis of evidence. This agenda needs political commitment of the highest order and the development of a people's movement.

BACKGROUND: Tackling neonatal mortality is essential for the achievement of the child survival millennium development goal. There are just under 4 million neonatal deaths, accounting for 38% of the 10.8 million deaths among children younger than 5 years of age taking place each year; 99% of these occur in low- and middle-income countries where a large proportion of births take place at home, and where postnatal care for mothers and neonates is either not available or is of poor quality. WHO and UNICEF have issued a joint statement calling for governments to implement "Home visits for the newborn child: a strategy to improve survival", following several studies in South Asia which achieved substantial reductions in neonatal mortality through community-based approaches. However, their feasibility and effectiveness have not yet been evaluated in Africa. The Newhints study aims to do this in Ghana and to develop a feasible and sustainable community-based approach to improve newborn care practices, and by so doing improve neonatal survival. METHODS: Newhints is an integrated intervention package based on extensive formative research, and developed in close collaboration with seven District Health Management Teams (DHMTs) in Brong Ahafo Region. The core component is training the existing community based surveillance volunteers (CBSVs) to identify pregnant women and to conduct two home visits during pregnancy and three in the first week of life to address essential care practices, and to assess and refer very low birth weight and sick babies. CBSVs are supported by a set of materials, regular supervisory visits, incentives, sensitisation activities with TBAs, health facility staff and communities, and providing training for essential newborn care in health facilities.Newhints is being evaluated through a cluster randomised controlled trial, and intention to treat analyses. The clusters are 98 supervisory zones; 49 have been randomised for implementation of the Newhints intervention, with the other 49 acting as controls. Data on neonatal mortality and care practices will be collected from approximately 15,000 babies through surveillance of women of child-bearing age in the 7 districts. Detailed process, cost and cost-effectiveness evaluations are also being carried out. TRIAL REGISTRATION: http://www.clinicaltrials.gov (identifier NCT00623337).