Women's participation in microfinance-based self-help groups (SHGs) and the resultant social capital may provide a basis to address the gap in health attainment for poor women and their children. We investigated the effect of combining a health program designed to improve health behaviours and outcomes with a microfinance-based SHG program.A mixed method study was conducted among 34 villages selected from three blocks or district subdivisions of India; one in Gujarat, two in Karnataka.A set of 17 villages representing new health program areas were pair-matched with 17 comparison villages. Two rounds of surveys were conducted with a total of 472 respondents, followed by 17 key informant interviews and 17 focus group discussions.Compared to a matched comparison group, women in SHGs that received the health program had higher odds of delivering their babies in an institution , feeding colostrum to their newborn , and having a toilet at home . However, while the change was in the expected direction, there was no statistically significant reduction in diarrhoea among children in the intervention community , and the hypothesis that the health program would result in decreased out-pocket expenditures on treatment was not supported.Our study found evidence that health programs implemented with microfinance-based SHGs is associated with improved health behaviours. With broad population coverage of SHGs and the social capital produced by their activities, microfinance-based SHGs may provide an avenue for addressing the health needs of poor women. •Combining a health program with SHGs is associated with an improvement in key health behaviours in the study population.•However, the program led to no significant improvement in diarrhoea among children, and no effect on spending on treatment.•The structure of SHGs and duration of association played a role in promoting trust between members and the host organization.•Working with SHGs provides a basis for addressing the gap in health attainment for women and their children. Self-help groups (SHGs), usually comprising 10–20 individuals (predominantly women) and organized to save money and obtain microfinance, are an important initiative that provide access to capital and promote livelihoods among the rural poor in India. These SHGs are promoted extensively through government and non-government organizations and were estimated to reach 93 million members in 2012.In a previous study in India, we found that the presence of an SHG in a village was associated with improved maternal and child health knowledge and practice.11However, despite this evidence, using these mechanisms to address the health needs of the poor does not appear to be a high priority for health planners in India. And while India has large programs – both government and non-government organized – to promote microfinance schemes to poor women, there is limited evidence on the role of health programs attached to microfinance-based SHGs in improving health outcomes of the poor. This paper reports on the findings from a field study designed to investigate whether combining a health program with a microfinance-based SHG program improves health behaviours and outcomes.To assess the effect of combining a health program with a microfinance-based SHG program, a difference-in-difference analysis was conducted through two rounds of surveys to collect baseline and one-year follow-up data from intervention and matched comparison group. The quantitative field study was conducted during 2012 and 2013, followed by a qualitative investigation of the contextual factors and challenges associated with the health program. The study was conducted among 34 villages selected from three blocks or district subdivisions of India: Dahegam in Gujarat, Udupi and Gadag in Karnataka.Jana Jagruthi or public awareness program and included health awareness sessions at routine credit group meetings, home visits by a village health worker, the promotion of low cost sanitary latrines, and Sampoorna Suraksha, an insurance scheme with health cover. For the health insurance, an annual contribution of Rs. 190 (US $3) was collected from each member, providing protection for up to Rs. 5000 (US $83) in medical expenses per year.Women in these villages had access to microfinance programs from two organizations: the Self Employed Women's Association (SEWA) in Gujarat, and the Shri Kshetra Dharamstala Rural Development Project (SKDRDP) in Karnataka. Both organizations provided a health program for member groups. In the case of SEWA, the health programs were organized as member-owned cooperatives, and included primary health care delivered through stationery and mobile health camps, health education and training, and the production and marketing of traditional medicines. The SEWA health program was supported by funding from philanthropic organizations. SEWA also offered insurance schemes that included health cover for its members. The health package covered hospitalisation costs up to Rs. 2000 (US $33) annually for an individual, with options for family coverage up to Rs. 25,000 (US $416) per year, against payment of an annual premium. Health and hygiene programs at SKDRDP started as a These health programs were available to some, but not all, program areas of the two organizations. At the start of this study, half of the participating villages were identified for roll out of the health program – the intervention villages. For the purpose of this study, we selected matched comparison villages from the same block. The comparison villages were from the microfinance program areas with no health program. Village pairs were matched on four criteria: population size, SHG membership, location in the same block but not with a common boundary. The matching exercise was carried out primarily by the program managers from the participating organizations. To test the validity of the matching process, before the start of the health program we conducted a survey of the intervention and comparison villages to collect information regarding key socio-economic characteristics. These characteristics were compared to evaluate the effectiveness of the matching process.Improving the health of mothers and children by improving the quality of sanitation and reducing financial burden due to illness were priority issues common to both organisations. Hence, five indicators were selected to assess the benefit of combining a health program with SHGs: diarrhoea among children, institutional delivery of babies, colostrum feeding to newborns, having a toilet at home, and money spent on treatment. These indicators were selected in consultation with the respective program managers of the two organizations.The survey questions were defined in the following ways: diarrhoea in the youngest child less than two years old, and occurring in the two weeks preceding the survey; institutional delivery and feeding colostrum to newborn babies (for the youngest child less than two years old during the baseline survey and less than one year during the follow-up survey). The variable for money spent on treatment was an aggregate of four questions related to different types of medical expenditure and was asked for each family member.Changes in episodes of diarrhoea in children is a sensitive indicator of health program effectiveness in the short-term.Two rounds of the survey were conducted with 472 respondents: 219 from the intervention villages, and 253 from the comparison villages. Baseline data were collected before the roll out of the health program, and the follow-up survey was conducted with the same respondents after 12 months. The inclusion criteria at the time of the baseline survey were women of reproductive age having a child aged less than two years. An equal number of respondents were recruited from intervention and comparison villages. A list of SHG members in the intervention and comparison villages was made available by the participating organizations. Based on the list, we firstly identified eligible houses in each village. Based on the calculated sample size, we then selected households proportionate to size using systematic random sampling.Face to face interviews were conducted with the respondents. A questionnaire was used to collect socio-economic information, general health status, and key indicators. Questions related to socio-economic variables were the same as those used in the District Level Household Survey – phase III,Responses from the three blocks were aggregated to perform the analysis. Disaggregated analysis by study sites was deemed inappropriate as sample sizes were too small if each of the two groups were analysed separately. The analysis followed two steps. A test of equality on the study variables was performed on the baseline survey data to assess the validity of the village matching process. This was done through chi square value of pooled estimates for intervention and comparison groups, and Wilcoxon equality of medians test where median value is reported.A difference-in-difference analysis was performed to assess the additional impact of the health program, controlling for the baseline measures. The following explains our analysis:Let intervention group Then The regression equation then can be written as:Y is the outcome of interest (five outcome variables), A takes the value one if respondent i from block j were from an intervention area , T takes the value one if survey is conducted at the time of the one year follow-up period, X is a vector for control variables. The regression coefficient of interest is the interaction of intervention group and follow-up period, referred to as β3. This model assumes a common trend across the intervention and comparison groups, that is, in absence of the health program, the unobserved differences between the intervention and comparison groups would be same over time. As both the intervention and comparison group are matched at baseline, and are from the same block, assuming a common trend across the groups is reasonable.Binary logistic regressions were performed on the binary outcome variables: institutional delivery, childhood diarrhoea, toilet at home and feeding colostrum to newborns. Adjusted odds ratios, with 95% confidence intervals, were reported as increased or decreased odds of the occurrence of an event. For the continuous outcome variable, money spent on treatment, a two-part model was applied: first, respondents who had no expenditure on treatment in the previous month were identified, and then a linear regression was performed among those respondents who had spent money on treatment in the previous month. Per capita monthly expenditure on treatment was calculated by dividing the total expenditure on treatment by the number of family members in the household. Monetary values are reported in US$ with one US$ corresponding to 60 Indian Rupees.All regression equations were controlled for respondents education, types of house , and monthly household expenditure. The three blocks included in the study have different socio-economic status which may have confounded the result. Hence we included the blocks as a categorical variable to control for the block effects.A qualitative study was conducted after the follow-up survey in the intervention villages to understand the contextual factors and challenges associated with the health program. In total, 17 key informant interviews with program managers and village health workers (VHWs), and 17 focus group discussions (FGDs) involving 153 community members were conducted in order to achieve data saturation. Both the FGD and key informant guides were designed to seek information on three themes: community context, group structure and functioning, and contribution of the health program. All interviews were conducted in the local language.pucca house. Respondents from Udupi had better housing, compared to Gadag and Dahegam. The majority of respondents  had access to tap-water, either at their own house or from a near-by public source. Again, respondents from Udupi and Dahegam had better access to tap-water, compared to respondents from Gadag. A quarter of the respondents did not have any formal education. Average monthly household expenditure was US$ 73 for both groups.A description of the socio-economic characteristics of the sample at baseline is presented in The intervention and comparison groups were not significantly different on key socio-economic variables: type of housing, access to piped water, and average monthly household expenditure. This supports the validity of the village matching process.Among the 17 key informants interviewed for the qualitative study, three were program managers (one from each program block) while the rest were village health workers. Additionally, 17 FGDs were conducted with a total of 153 participants. The mean age of the participants was 28 years (range: 25–30) .Compared to the comparison group, SHG members with a health program had higher odds of delivering their babies in an institution, feeding colostrum to newborns, and having a toilet at home after one year of program implementation. However, the SHG plus health program group showed no significant improvement in the incidence of diarrhoea among children and no effect on money spent on treatment. The results were adjusted for pre-program measures, and socio-economic characteristics of the household. The following section discusses the results for each of the five selected indicators.Before implementation of the health program, 76.4% (149/195) of women in the intervention villages, and 80.0% (184/230) of women in the comparison villages reported delivering their most recent baby in an institution. At follow-up, 70 women from the intervention villages, and 93 women from the comparison villages had a delivery experience. The proportion of respondents reporting delivery in an institution during the 12 months preceding the follow-up survey rose in both groups, but significantly more so in the intervention group (from 76.4% to 95.7%) than in the comparison group (from 80.0% to 86.0%). The difference between groups after adjustment for baseline values was significant   suggestiBefore implementation of the health program, 56.3% (103/183) of respondents in the intervention villages, and 59.3% (118/199) of respondents in the comparison villages reported feeding colostrum to their newborns. During the follow-up survey feeding colostrum to newborns was reported for babies born during the 12 months follow-up period: 70 respondents from the intervention villages, and 93 respondents from the comparison villages. There was a larger increase in the proportion of newborns fed colostrum in the intervention group compared to the comparison group; the percentage went up from 56.3% to 77.5% in the intervention group and from 59.3% to 62.0% in the comparison group. There was a statistically significant difference between the intervention and comparison groups at the follow-up period, after adjustment for baseline characteristics  . The stuHaving no toilet is an insult to women. We are forced to defecate in the open field. If males are walking on the road, we have to stand. This is shaming. It was not easy. After attending the sessions on cleanliness and personal hygiene, I decided that for the sake of my two adolescent daughters I needed a small toilet. I had to convince my husband and my in-laws of the need to have a toilet of our own. .Before the start of the health program, 62.6% (137/219) of respondents in the intervention villages and 51.8% (131/253) of respondents in the comparison villages reported having a toilet at home. This is more than the estimate of 46.9% toilet ownership in India as per the 2011 census.This year we had fewer cases of diarrhoea among children, compared to the same period last year. I would count this as a success. We are more aware about how to keep children clean, how to assist growing children, what food should be given, feeding boiled water to small children, etc. She [NGO health worker] advises us to give salt-sugar solution and ORS if any child suffers from diarrhoea. .Before implementation of the health program, 26.0% (57/219) of respondents in the intervention villages, and 25.3% (64/253) of respondents in the comparison villages had a child who suffered from diarrhoea in the preceding two weeks. This fell to 11.0% (24/219) and 12.6% (32/253) at the time of the follow-up survey. The proportion of children suffering from diarrhoea went down in both the intervention and comparison villages. While respondents from villages in the intervention group had 14% lower odds of having a child suffering from diarrhoea in the study reference period compared to those in the comparison villages the difference was not statistically significant  . NeverthAbout 40% of the respondents surveyed at both time points reported no expenditure on treatment for health problems in the previous month. Among respondents who had spent money on treatment, the per capita spending at baseline was higher in the comparison group than in the intervention group (US$ 6.64 in the intervention group compared to US$8.80 in the comparison group). This declined to US$ 3.93 in the intervention group, and to US$ 4.19 in the comparison group. The adjusted estimates suggest that the study hypothesis that the health program would result in a reduction in money spent on treatment is not supported by this result .The qualitative study among the intervention villages focussed on understanding the community context, experience in implementing the health program, and challenges in program implementation. The following section discusses the findings from the qualitative study.Program managers reported that primary health care services in their villages were limited; government health facilities were either not present or, if present, were under-resourced. Moreover, poor health awareness meant that people often resorted to unqualified providers for care, or did not adopt appropriate approaches to prevent diseases. For example, people defecated in the open, women had poor sanitary practices, and traditional beliefs about child care practices were common.They spend their meagre resources on food that barely meets their nutritional requirements. Malnutrition and sickness force them to contain health spending, and they are unable to even seek treatment thereby reducing their family income. This creates a vicious cycle. It is impossible to escape the clutches of poverty. Poor health is one of the biggest contributors to poverty; members needed awareness of good health, appropriate and affordable healthcare options. .Some program managers said that the primary business of a microfinance institution is to lend money to SHG members. This money is meant to develop businesses that can be used to generate income. While investing the borrowed money for business expansion was an important option for self-sufficiency of members, such a mechanism sometimes met with limited success due to illness and lack of health awareness among the SHG members. Loans taken for generating income were being used to meet the cost of treatment for health problems if someone in the house fell sick. Respondents reported that some SHG members were occasionally unable to repay their loans due to illness.Through training we gained knowledge about family planning, diarrhoea among children, immunization, breast feeding, diet of the mother, and how to maintain hygiene within the community. My own beliefs about child care practices have changed as a result of the training. .After our regular [SHG] meeting, we organized a discussion on one topic at a time. Some meetings focused on diarrhoea and cleanliness, some focused on health of girls in our community, while others focused on sanitation. We reinforced the health messages during home visits. .The program was designed around a cadre of VHWs, nominated by the SHGs. The VHWs worked to raise awareness of reproductive and child health, immunization and childcare, hygiene and sanitation; to refer people with danger signs of pregnancy and child health complications; and to promote a health insurance product to cover health-related consultations and treatments. Many VHWs said that the contents of the training sessions challenged some of their own misguided health beliefs, and this learning was subsequently shared during the SHG meetings. Some respondents reported that non-members were also encouraged to participate in the health education sessions:Our group is formed on the principle of cooperation, trust, and respect…By joining the SHG I am happy. Earlier if I asked for Rs. 10 from my husband, I used to get a scolding. After opening accounts with the group, I am also getting interest on my savings. I also got Rs. 50,000 [US $833] as a loan for my daughter’s marriage. .A strong and common theme emerging from the interviews and discussions was trust and solidarity between group members and with their respective organizations. Respondents attributed their trust and confidence with the participating organizations to their origins: one of the organizations is associated with a famous and respected temple trust in Udupi (SKDRDP), while another emerged as a trade union for self employed women (SEWA). Both organizations had been involved with microcredit activities in the study areas for over a decade. Another common theme emerging from the discussions was members' belief that their groups were based on the principles of equality, trust, discipline, respect and helping each other. Members believed that the group leader played a key role in setting up and maintaining the group values and norms.We used to face difficulty in treating water for drinking. The water obtained from the well is not suitable for drinking. SKDRDP supported us in setting up a water treatment plant in our village. Our group now runs the plant. One of us is trained in maintaining the plant. We also sell the water at low-cost in our village. .Over the course of discussions, participants described the ways in which the organizations influenced their daily lives. SHG meetings acted as a platform for discussing issues that commonly concerned the communities, such as education of children, access to safe drinking water, sanitation, and illness. Respondents also narrated incidents where the organizations provided material assistance to help them solve local issues such as support for setting up a local water treatment plant, constructing toilets at home, and setting up milk dairy cooperatives that were then maintained by SHG members. However, there were larger issues such as improvements in road and drainage infrastructure, issues related with employment and farming that could not be addressed at the SHG level. These issues were raised with the village panchayat  by the SHG leaders and organization representatives.The interviews and FGDs highlighted several challenges encountered by VHWs while delivering the health program. It was difficult to change behaviours that are deeply entrenched in the community. The program design and delivery also presented a challenge in some places.They usually take medicine from a small hut/shop. If they cannot see any change then they go to a qualified doctor. We do constantly remind them to go to a qualified doctor. However, it is usually the head of the family who takes the decision. Also there are superstitions and religious beliefs that stop them from taking care. .In-depth interviews with key informants identified some of the challenges that negatively affected efforts to achieve behaviour change. These included: traditional beliefs about health and illness; relying on unqualified traditional healers as the first point of care resulting in delayed care seeking from the formal health service; and money wasted when seeking care from unqualified health practitioners. On respondent said:The primary recipients of microcredit are women, and hence the health programs were developed with women as the primary target group. While participants believed the women-centric approach has promoted their participation in household decision making and control over resources, they also highlighted instances where control over resources was the cause of tension and intimate partner violence within the family, particularly when males felt that their dominance was being challenged. SHG members called for programs that also involved males in the behaviour change process, particularly related to alcohol and substance abuse, and risky sexual practices.We have a long way to go. Our members have faith in us. However, others doubt our intention. There are ignorance and wide-spread superstitions. Initially we faced difficulties in convincing people to change their behaviours. .VHWs highlighted several programmatic challenges in delivering the health program. Some challenges related to the way they were compensated, while others related to procedural issues. In some instances, the VHWs complained that the honorarium was not sufficient to compensate for the responsibilities associated with the program, while for others motivating the community to change their long held beliefs and behaviours was difficult. One respondent said:There were too many delays in processing the health insurance claims. We come from faraway places. When the delay occurs we have to miss our bus to go back home. .There were also procedural delays in processing SHG members' health insurance claims. This contributed to poor perception of the health insurance product. There were instances of delays in receiving reimbursement after discharge from hospital, as administrative staff at the hospital did not always cooperate in providing the information or documentation required to process the claim. Sometimes the beneficiaries did not carry the required documentation (for example an insurance card) with them to the hospital. This led to delays in authorization of the payment procedure at the hospital. As one respondent reported:However, the program managers also mentioned that, overtime, they had succeeded in overcoming most of the initial hurdles through a system of routine feedback to the VHWs, dialogue with concerned stakeholders, and training. These activities had resulted in members feeling encouraged to increase the frequency and quality of participation in group activities.Program managers and VHWs emphasized the need for more interaction with local health officials to upgrade their own knowledge related to health issues affecting their communities. Some of the critical issues identified for skill building were related to adolescent health issues, sexually transmitted infections, and government programs and schemes operational in their villages.On being asked about future program efforts, program managers stressed the need to promote cleanliness in their villages, work with local authorities to build and maintain drainage systems, and strengthen programs that aimed to stop the practice of open defecation. Participation of males in the programs was listed as another priority area. Additionally, the need to attend to broader development issues such as creating opportunities for employment, and training in vocational skills were highlighted during the course of interviews with the program managers.The findings from this study indicate that compared to a matched comparison group, an intervention combining a health program with microfinance-based SHG activities positively influences some, but not all, health behaviours and outcomes over a one-year follow-up period. Adjusting for baseline measures, and controlling for respondents' education, type of house, monthly household expenditure, and geographical location, being a member of a village with an SHG health program was associated with a higher odds of delivering their most recent baby in an institution, feeding colostrum to their newborn babies, and having a toilet at home, compared to a matched comparison group.The effects observed in our study are consistent with existing evidence. However, most of the existing evidence found changes in a controlled research setting, while our study was in a real-life setting associated with real-life challenges to implementation.The SHG structure emphasizes social cohesion and promotes collective action related to members shared needs. While the health programs in the study villages were new initiatives, both organizations (SEWA and SKDRDP) had implemented microcredit activities in those villages for more than a decade. Long duration of association with the community, SHG structure, and reputation of the organization seems to have played a crucial role in promoting trust for their organization among members. Personal bonds and trust of SEWA members has been documented in several ethnographic studies.24While change occurred in the expected direction, there was no evidence of a statistically significant reduction in diarrhoea among children in the intervention community, and the study hypothesis that the health program would result in a reduction in money spent on treatment was not supported by the results. Possible reasons for this mixed effect could relate to the way the health program was delivered. In the absence of a process evaluation of the health program we have limited information on the program's content, quality, and frequency of delivery across the different sites. An explanation for the lack of success in relation to some indicators could be the fact that the VHWs were inexperienced – being the first year of program implementation, they were new in their role so had not had time to consolidate their knowledge and gain confidence. Time and mentoring may be necessary for VHWs to learn to function effectively in this role and to gain respect for their knowledge. More changes may have been evident with a longer follow-up period. Additionally, our qualitative findings highlighted initial challenges in motivating the community, especially issues with honorarium payments for VHWs, delays in processing health insurance claims, and delays in seeking care from qualified healthcare providers due to traditional beliefs about health and illness. While several of these hurdles were ultimately addressed, a longer period of time would be required to implement the health program in its entirety than was possible in this study. This mixed program effect is, however, not uncommon among completed research on this subject.28Our study found evidence that combining a health program with microfinance-based SHG activities is associated with a significant increase in women delivering their babies in an institution, feeding colostrum to their newborn, and a non-significant increase in having a toilet at home. However, the program did not produce a significant change in the outcome indicator related to diarrhoea among children, and had no effect in reducing money spent on treatment.With broad population coverage, microfinance-based SHGs provide an avenue for increasing universal health coverage and particularly for addressing the health needs of poor women. Our results indicate that further research on this theme is required. There are additional reasons, from a social perspective, for investigating the possible positive impact of these programs. These include the impact of broad population coverage provided by SHGs and the social capital produced by their activities. A key area of future research would be an assessment of cost of adding a health program to SHGs more widely, and an analysis of cost-effectiveness of such an integrated approach. Public health planners stand to benefit from the membership-based structures and social capital that already exist through microfinance-based SHGs. However, such programs should not be viewed as a panacea for government failures. Rather, the SHG-based programs can be seen as complementary to public provisioning of health services, and as a means for increasing awareness about entitlement for public services in the community.Dr. James Hargreaves from the London School of Hygiene and Tropical Medicine provided useful guidance in the study design. Thanks are due to the NGO program managers, village health workers and study participants for sharing their experience.The interview process was explained to respondents in plain and relevant vernacular language. Before initiating the survey, interviews or FGDs, written informed consent was obtained from eligible respondents who were literate. Verbal informed consent was obtained from women who were illiterate, after the purpose and proceedings of the study were explained to them. The research protocol for this study received approval from both the Nossal Institute for Global Health Human Ethics Advisory Group at the University of Melbourne, Australia (Ethics Id: 1239067.1), and the Institutional Ethics Committee of the Public Health Foundation of India, New Delhi, India (TRC-IEC-124/12).The research was supported by a Welcome Trust Capacity Strengthening Strategic Award to the Public Health Foundation of India and a consortium of UK Universities, and a Research Higher Degree grant from the Nossal Institute for Global Health at The University of Melbourne, Australia. The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.None.


Global mental health (GMH) advocates for access to and the equitable provision of mental health care. Although the treatment gap is a useful construct to measure access and equitability of care, it fails to communicate the real-life consequences of the treatment gap and the urgent need to address care disparities.The aim of this article is to present a perspective on the practical application of the principles of GMH to understand the real-life impact of the treatment gap and the approaches taken to improve treatment coverage in Ethiopia.A case study method is used.Multiple international collaborations undertaken in Ethiopia and facilitated by GMH to improve care, capacity, and the evidence base for increased treatment coverage are described briefly. A series of steps taken at the local and national levels to address the treatment gap are highlighted. The stories of two patients are also presented to illustrate the real-life consequences of the treatment gap and the potential transformational impact of addressing the treatment gap on patients, families, and communities.GMH has a key role to play in addressing the treatment gap, which improves the life of people with mental disorders, their families, and their communities. However, national-level policy support and coordination are essential for any realistic improvement in treatment coverage. The reflections offered through the case examples may have utility in similar low-income settings. Global mental health (GMH) may be defined narrowly as a subset of global health  that advThe implication of this huge treatment gap in LMICs is sobering. Very many people with severe mental illnesses, such as psychosis, are kept in chains and hidden away for years. These patients are often the victims of stigma and discrimination, invariably unproductive, and often physically and mentally abused , 11. SucApplied practically in a LMIC setting like Ethiopia, GMH should provide data to demonstrate the impact of the treatment gap and a contextualised framework or approach to help reduce it. The aim of this article is therefore to illustrate the real-life consequences of the mental health treatment gap in LMICs with a case example from a rural area in Ethiopia, and then to outline positive responses and recent developments at the local (district) and national levels to address the treatment gap – lessons that may have resonance in other low-income settings worldwide. We chose Ethiopia as a case example primarily because we have more intimate knowledge of Ethiopia than other LMICs. But Ethiopia may also typify LMICs in terms of its developing economic status, restructuring, population growth and structure, urbanisation, and health needs.We employed the case study method, which makes use of both quantitative and qualitative approaches. The method is considered ideal when multiple interventions are involved which cannot be readily aggregated and when outcomes are long term and likely to be overdetermined . The casThe following example illustrates the impact that lack of accessible care had for one woman and her family in Ethiopia.Case Example 1: The couple shown in This is a familiar story. In Ethiopia, as in many low-income countries, only a very small percentage of patients, in the order of 5 to 10%, who require care that may be life-saving actually receive it , 16. ThiCoverage can be simply defined as the proportion of people with a given condition who receive appropriate treatment. The following example, the Butajira project , demonstPanel 1The mental health treatment gap has a far-reaching impact on people and society that is not immediately apparent in discussions about global mental health or the treatment gap.Given the complexity of addressing the treatment gap, evidence applicable to the specific context should be sought, as exemplified by the experience in Ethiopia.Integrated services on their own are not adequate. The stepped-care model, which engages the community, integrates mental health care into primary care, and provision of specialist support is important.Community engagement improves demand, supports community integration, and has the potential to improve quality of care.Integrated care has the potential to improve accessibility of care as long as supervisory and quality control mechanisms are in place.Mental health services should provide support to integrated care and provide services linked with the integrated care.Services with specialist capacity to address complex needs should not be neglected.Governments and health ministries should provide leadership in meeting the treatment gap needs as exemplified in Ethiopia.Case Example 2: Mr B is currently the chair of an Idir – a traditional self-help community organisation for supporting members during times of difficulty, such as a death in the family – representing about 160 households. Four years ago, Mr B was a chair of a sub-district administration, where decisions of high impact relating to the residents are made. He is married with nine children, all in school or at work. He has a flourishing farmland, and owns the best house in the neighbourhood. But it was not always this way for Mr B. About 12 years earlier, he had developed a very serious psychotic illness. Because of his assaultive behaviour, he was chained for the better part of 4 years and deserted by his family and neighbours, with the exception of his wife, whom he now praises profusely. He was taken around to all known traditional healing sites in the area to no avail before he was found in chains by Butajira project field workers while the workers were making home visits. He was treated successfully by the project service and has since been well enough to lead not only his own family but also a sub-district of about 1,000 households. He was able to build his fortune and become a highly respected member of society. Mr B has been out of treatment for the past 2 years and attends mental health meetings and trainings to explain his recovery . Trainee psychiatric nurses received 9 months of training that involved a 3-month taught course and 6 months of internship. For the internship, the trainees went back to their regions, established out-patient clinics, and were supervised by psychiatrists from Addis Ababa. The trained psychiatric nurses received periodic refresher courses, and the supervision was eventually phased out when it was believed that the psychiatric nurses could run the programme independently. The consequence was the expansion of specialised mental health services to 58 sites across the country, a major achievement for any service programme.Until 1987, specialist psychiatric services in Ethiopia were centralised in the capital city of Addis Ababa and provided only at the university hospital and the specialised psychiatric hospital . A psychiatric nursing programme was then initiated with the support of the World Health Organization (WHO)   has set Additionally, the financial management system has become more flexible so that the health care facilities and districts themselves have sufficient authority to make the necessary medical supplies and other resources available at the primary care centres.http://www.prime.uct.ac.za), an international research and implementation programme funded by the UK Department for International Development, is now assessing the practical requirements of service integration and scale-up (http://www.affirm.uct.ac.za). Furthermore, the European Commission funded the Emerging mental health systems in low- and middle-income countries (EMERALD) project, putting into place a series of health system strengthening measures designed to train primary care staff in evidence-based interventions on a long-term basis. The project aims to provide universal mental health care coverage across six LMICs, including Ethiopia . Finally, a relatively large-scale project funded by the Grand Challenges Canada, the Biaber project, aims to look at scale-up of psychological interventions, primarily interpersonal therapy in a primary care setting. This study fills an important gap in the scale-up of services in low-income countries.The Mental Health Gap Action Programme (mhGAP) , a WHO-sscale-up . The eviSpecialist care provisions and research capacity are growing in parallel, with input from GMH partners. The Toronto Addis Ababa Psychiatry Project (TAAPP) , which bThis article demonstrates three important issues: 1) the serious personal  consequences of the lack of accessible care (the treatment gap), 2) the life-transforming impact of provision of care, and 3) the potential to expand services to reach the population in need through affordable scale-up of care. The treatment gap, as demonstrated by the two case examples, is not an abstract concept but a concrete issue with a real impact on citizens. It leads to personal and family distress, significant financial cost, loss of human rights and dignity, and exploitation. Because of the structure of the care system, the impact on families is unmitigated and may even affect multiple generations, as exemplified by the first case. The situation faced by the pregnant woman in the first case example also demonstrates that the care of the centralised services is not geared to address complex needs. Often, in the effort to expand integrated care, tertiary services are neglected. It is essential that some services are able to provide complex care. The treatment gap, even with the additional service expansions, remains substantial. If this is extrapolated to the entire country of Ethiopia, millions of people with mental illness and their families endure the consequences of mental illness, as exemplified by these cases. Intellectual debates , 31 oftewww.emerald-project.eu). Ethiopia is also a very good example on what governments should do. The government has demonstrated its commitment to the scale-up of mental health care by providing policy guidance and by supporting scale-up through the mhGAP programme. Addis Ababa University, the leading research institution in the country, has also included mental health as one of the priority areas for research. However, integration alone  cannot be the solution. Specialist capacity for services and research is also essential, as shown in Ethiopia. Moreover, the work requires urgency and diligence on all sides: governments should push for achieving their targets within a set timeframe, health care professionals need to be guided by a sense of public service, and the community should be aware of and support local initiatives as well as demand the care it deserves. The urgency to expand system capacity, care staff capacity, and staff morale and well-being should be taken seriously. Along with integrated care, the pathway to patient care should also include expansion of specialist capacity to enable training, mentoring, supervision, and care. Attention should be paid to patients presenting to general medical settings with complex needs. These patients are likely to require specialist inputs akin to what would be a consultation liaison service in the West. It is safe and essential to fund mental health research and service delivery. Additionally, the focus of the current effort to scale up service is rightly on expanding coverage to the rural population. But cities are rapidly expanding. There is a large movement of population from the countryside to the cities. There seems to be a considerable change in the social fabric of the population, for example in terms of the volume of reliable social networks ; on how local integration should work (PRIME project); and on how system-level integration should look (EMERALD: networks . This is


Several studies in recent years have shown differences in the composition of the gut microbiota in children who are exposed to different conditions before, during, and early after birth. A number of maternal factors are responsible for the establishment and colonization of gut microbiota in infants, such as the conditions surrounding the prenatal period, time and mode of delivery, diet, mother’s age, BMI, smoking status, household milieu, socioeconomic status, breastfeeding and antibiotic use, as well as other environmental factors that have profound effects on the microbiota and on immunoregulation during early life. Early exposures impacting the intestinal microbiota are associated with the development of childhood diseases that may persist to adulthood such as asthma, allergic disorders , chronic immune-mediated inflammatory diseases, type 1 diabetes, obesity, and eczema. This overview highlights some of the exposures during the pre- and postnatal time periods that are key in the colonization and development of the gastrointestinal microbiota of infants as well as some of the diseases or disorders that occur due to the pattern of initial gut colonization.Postnatal maturation of immune regulation is largely driven by exposure to microbes. The gastrointestinal tract is the largest source of microbial exposure, as the human gut microbiome contains up to 10 The following section highlights some of the external factors that affect the initial colonization and establishment of gut microbiota in infants Table .E. coli serotypes were found in both the mouths of babies and in their mothers’ feces immediately after birth. This implies that the proximity of the birth canal and the anus play an important role in the transmission of microbes from the mother to the infant. In addition, bacteria present in the mother’s vagina immediately before birth were reported in the nasopharynxes of over 50% of babies born vaginally  they receive, which could also be stratified by income status, mode of upbringing, or geographical location. The microbiota of children in Burkina Faso was found to be dominated by Bacteroidetes, compared with that of Italians, which was dominated by Firmicutes . Similarylotypes .Bifidobacterium bifidum, Bifidobacterium breve, and Staphylococcus aureus (The influence of the mother on the child’s microbiota is evident during the first year after birth . This efs aureus .Lactobacilli and Bacteroides at 5 weeks of age, all of which are associated with beneficial effects (After birth, environmental, oral, and skin microbes from the mother are mechanically transferred to the newborn in different ways, which may influence the diversity of intestinal microbiota in the neonate. For example, biodiversity in the homes, in the surrounding environment and in family members who have a close or constant contact with the baby have a direct impact on the diversity of microbes that are transferred to the infant –71. In a effects . The motEscherichia coli and Bifidobacteria is associated with higher numbers of CD20 + B cells that express the memory marker CD27 at 4 and 18 months of age (Enterococcus species and Candida albicans, and the probable occurrence of NEC in preterm infants. These findings may not be exclusively due to a disturbed intestinal microbiota because other confounding factors may also be responsible for NEC; however, further investigation will provide useful information on this topic and further clarify the existing discrepancies.Gut microbiota are generally associated with the development and maturation of the immune system . The imms of age . Disrupts of age , 80. Mols of age , 82. Thes of age . A low gs of age . Early-ls of age , 85. Alts of age , 87. Häls of age  reportedLactobacillus johnsonii, which itself can confer airway protection when orally supplemented as a single species (The birth order or family size and the presence or absence of pets have also been implicated in the initial microbial colonization in infants. Over two decades ago, Strachan observed that children who had older siblings were less likely to manifest hay fever as adults, as compared to firstborn children, which could be due to a protective effect of infections brought home by the older siblings . Similar species .Clostridium perfringens in children who developed eczema in the first 2 years of life, whereas a lower abundance of Bifidobacterium was observed in those who developed eczema at 5 years of age. The authors suggested that relative abundance of selective microbial targets might contribute to the subsequent development of eczema in childhood. Studies have also associated gut microbiota with the development of T1D (Selective microbial targets have been associated with infants developing eczema . Yap andt of T1D . For exat of T1D . Converst of T1D . In addit of T1D . Breastft of T1D .The use of antibiotics is generally known to change the gut microbiota. A meta-analysis on antibiotic use in infants reported that wheezing and asthma were related to antibiotic use . In addiLactobacillus acidophilus and Bifidobacterium infantis as well as other probiotics had less cases of NEC and a reduced mortality rate compared to the controls (Several methods can be used to attempt to modify disturbed gut microbiota and many of them have been implicated in the improvement of gut microbiota in early childhood. However, an extensive discussion of the methods used to modify gut microbiota is beyond the scope of this review and only brief highlights on probiotics are included. As defined by the Food and Agriculture Organization/World Health Organization, probiotics are live microorganisms that, when administered in adequate amounts, confer health benefits on the host. The mechanisms by which probiotics exert beneficial effects on the host are currently a main area of focus although this may vary depending on the species or the strain involved. In this case, infants fed with a blend of controls , supportcontrols  argue thcontrols , 98, andcontrols , 100. Focontrols –102.The characteristics of the inherited microbiome are likely very important in understanding offspring health as recent research suggests that aberrant metabolic phenotypes can be directly attributed to intestinal bacterial communities. Here, we have summarized some of the current interactions and associations on early-life exposures that may influence the development and colonization of the gut microbiota in infants and disease conditions that may result due to the nature of colonization. Some studies have already demonstrated the predictive power of the microbiota in enteric diseases while others have actually conducted research and consistently reported similar findings, although discrepancies do exist. In general, a reduction in overall bacterial diversity, a reduced abundance of commensal bacteria, and an increase in abundance of potentially pathogenic bacteria have been associated with immune-related disorders, and in some situations specific bacteria have being involved in the development of allergic reactions in both animal models and human studies. On the other hand, the importance of the gastrointestinal microbiome in defining the immune environment has been demonstrated in a number of studies, indicating that strategies to manipulate gut microbiome membership and function may have far-reaching implications for better health. This, therefore, shows that colonization by a certain subset of microbiota may be a threat or a benefit to the health of the infant during childhood and/or in adulthood. Consequently, future studies should focus on ways of promoting and/or maintaining colonization by the beneficial bacteria in infants who are exposed to compromising situations that encourage colonization by potentially pathogenic phylotypes. Prebiotics and/or probiotics have been suggested to have a promising impact in the prevention and treatment of some immune-related diseases by modulating gut microbiota and regulating host mucosal immune function; however, their efficacy is inconsistent and further studies and the exploration of other treatments are required.Whether the altered microbiome causes the disease or is the disease affecting the microbiome remains an issue of debate. However, for neonates, it is possible to argue that the first colonizers play a major role in the development of the disease because if this is not the case, then why are some disorders/disease conditions more common in infants born via caesarian delivery compared with vaginally delivered infants? Or, why do formula-fed infants more frequently have metabolic disorders as opposed to breast-fed infants? Other questions include why is it that the majority of potentially known pathogenic microbes are found in children exposed to antibiotics, born by cesarean section, or raised under high hygienic conditions, whereas there are more known beneficial microbes in their counterparts? In support of our argument, differences in the composition of the gut microbiota between infants living in countries with a high and a low prevalence of allergy and between healthy and allergic infants, have been reported even very early in life before development of any clinical symptoms of disease , suggestMeta-analyses have substantiated the association between some disease conditions with cesarean section, formula feeding, and use of antibiotics in infants. However, these conditions may result from the impact of differences or changes already observed in the gut microbiota, or they could result from other confounding factors. Advanced molecular microbiology approaches including functional metagenomic analysis may shed more light on factors that affect infant microbial colonization and extend our knowledge on bacterial species that are potentially undesirable or actually beneficial, and that can be considered as potential probiotics for novel formula development in order to closely emulate nature’s models. Future studies should, therefore, focus on functionally characterizing the gut microbiota of children with the aim of identifying some of the metabolic pathways and processes that may be targeted for modulation with beneficial microbiota, and consequently aid in management of the disease conditions that are associated with altered gut microbiota or colonization by potential pathogens.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.


Uganda changed its malaria treatment policy in response to evidence of resistance to commonly used antimalarials. The use of evidence in policy development—also referred to as knowledge translation (KT)—is crucial, especially in resource-limited settings. However, KT processes occur amidst a complex web of stakeholder interactions. Stakeholder involvement in evidence generation and in KT activities is essential. In the present study, we explored how stakeholders impacted the uptake of evidence in the malaria treatment policy change in Uganda.We employed a qualitative case study methodology involving interviews with key informants and review of documents. A timeline of events was developed, which guided the purposive sampling of respondents and identification of relevant documents. Data were analysed using inductive content analysis techniques.Stakeholders played multiple roles in evidence uptake in the malaria treatment policy change. Donors, the Ministry of Health (MoH), service providers, and researchers engaged in the role of evidence generation. The MoH, parliamentarians, and opinion leaders at the national and local levels engaged in dissemination of evidence. The donors, MoH, researchers, and service providers engaged in the uptake of evidence in policy development and implementation. Stakeholders exerted varying levels of support and influence for different reasons. It is noteworthy that all of the influential stakeholders were divided regarding the best antimalarial alternative to adopt.a priori will enhance uptake of evidence in policy development.Our results showed a diverse group of stakeholders who played multiple roles, with varying levels of support and influence on the uptake of evidence in the malaria treatment policy change. For a given KT processes, mapping the relevant stakeholders and devising mechanism for their engagement and for how to resolve conflicts of interest and disagreements The online version of this article (doi:10.1186/s13012-014-0150-8) contains supplementary material, which is available to authorized users. Since 2001, Uganda has changed its malaria treatment policy twice, after efficacy studies demonstrated significant resistance against first-line antimalarials . The useKT processes occur amidst a complex web of interactions between stakeholders, who are hereby defined as individuals who, or institutions which are affected by the policy change, directly influence it, or have an interest in the outcome even when not directly involved . In thisThe available literature highlights several potential roles that stakeholders may play in KT. For example, civil society organisations (CSOs)—which here are defined as formally organised non-profit groups concerned with public interests —reportedTomlinson et al. point out that the specific composition, roles, and impact of stakeholders in KT are influenced by the context within which KT processes take place and the nature of the policy . For exaThe present study is part of a larger study that seeks to enhance our understanding of how we can improve evidence uptake in health policy development. In our previous work, we explored the roles, relationships, and interactions of key stakeholders involved in KT in Uganda, without specific reference to a piece of evidence or a policy. Nabyonga Orem et al. showed that stakeholders in KT were perceived to play both positive and negative roles, as well as identified the challenges that they had to overcome to effectively play the positive roles Table  30].Tab.Tab30].TIn the present article, we explore how different stakeholders have shaped evidence uptake in relation to malaria treatment policy change in Uganda, with specific assessment of the roles they played and their level of influence and support. Furthermore, we investigated the extent to which the previously identified roles of stakeholders in KT in Uganda  differedThis case study employed qualitative methods to explore how the involved stakeholders impacted evidence uptake in the malaria treatment policy change process. The case study approach was chosen based on the need to understand complex contextual issues . Data weA timeline of key events was drawn based on the review of documents, in consultation with two persons from the WHO and two persons from the MoH who had each held malaria-focused positions for over 10 years. This timeline guided the identification of key milestones, the involved processes, the key documents to be reviewed, and the institutions involved, which subsequently informed the selection of respondents  in charge of medicine procurement and distribution and the National Drug Authority (NDA) in charge of medicine regulation Table .Table 2KIs were interviewed using an in-depth interview guide that comprised open-ended questions designed to elicit the respondents’ perceptions on whether evidence had been used and who the stakeholders were, the roles they played, and their level of interest in and support for evidence uptake in the policy change process. The interview guide was developed by the first author, was reviewed and refined by the research team, and was pretested with two volunteer colleagues in the WHO Uganda office, two technical officers in the MoH, and one researcher from the Makerere University School of Public Health. KIs were contacted by email or telephone and invited to participate in the study. All identified respondents agreed to participate and were interviewed. All interviews were conducted by the first author, in English and face-to-face. The interviews lasted an average of 45 min. During the interviews, the first author made additional notes to record initial findings and impressions that were used to augment the transcribed interviews.The timeline of key events guided the identification of relevant documents to be reviewed. We included a broad range of documents relevant to the case to ascertain the processes involved, the stakeholders, and their roles. All identified documents were retrieved and reviewed. Additional file Interviews were recorded, transcribed verbatim, and entered into MS Word software for editing as the first step towards a “formal” analysis. All interviews and reviewed documents were coded using QRS Nvivo Software Version 10. Content analysis techniques were used to construct emerging categories linked to the research issues . In the Converging issues were again reviewed by the rest of the research team. Where interpretation differed, consensus was achieved through revisiting the raw data and discussions. Where necessary, quotations that best represented emerging issues were slightly edited for flow, while preserving the meaning of the text. The findings from document analysis and from the analysis of KI interviews were integrated throughout the analysis.Informed consent was obtained from all respondents prior to the interviews. Study participants were informed about the purpose of the study and the scope of issues in the in-depth interview guide. Confidentiality was ensured in data management, and only aggregate information without subject identifiers is reported. All data were secured in a safe location accessible only to the study team. Ethical approval was obtained from the Institutional Review Board of the Institute of Tropical Medicine, Antwerp (Belgium) (IRB number IRB/AC/ac/197) and the Uganda National Council for Science and Technology (number SS 2920).the decision to change the malaria treatment policy was based mainly on evidence from efficacy studies, which showed high resistance of plasmodium falciparum to CQ”. Other types of evidence were also used. For example, one research remarked that “communities complained first `I have been taking this medicine for malaria with no improvement”. This was then picked up by the health workers and then by the scientists”. Additional different types of evidence were cited in all 18 documents that were reviewed.We integrated the results from the review of relevant documents and from the interviews with KIs. These findings are presented in three sections, namely, the roles played by the different stakeholders, the stakeholders’ level of support and influence, and other external influences on the uptake of evidence. The respondents reported that evidence informed the malaria treatment policy change, which was supported by the review of documents. For example, documentation of the malaria treatment policy change process in Uganda (MoH 2006) states that “having reached a consensus that the malaria treatment policy needs to change in light of high resistance to the first line anti-malarials, task forces including experts in malaria from the different institutions/agencies were commissioned to work out the policy change and implementation process”. The available documentation further indicated that the different task forces were expected to use available evidence in their deliberation. For example, the report of the supply chain management task force (MoH 2004) stated that “the task force calculated the amount of AL required based on the malaria prevalence, health seeking behaviour, and population growth rate”  in the NMCP who was very clear. Then there were people who were doubtful despite availability of evidence. If the technical programmes were very clear maybe even top management would have been convinced and rallied behind the decision. The technical programmes wavered in their positions and that could have had an influence on top management.” MoH respondent“some researchers did not think we needed to change to ACTs (AL). They were saying this was commercially driven and that other options like AQ and AS would have been more appropriate”. Some respondents felt that some researchers used evidence to exert pressure, as one journalist made the following remark: “there was a man called [Y] who wrote an article in the Lancet criticizing the MoH and WHO for sticking with CQ/SP as the first-line treatment. He was saying `look, you are having CQ/SP and both of them were having high resistance rates; so by combining the two you are not making matters any better’”.Researchers were reportedly very influential because they were highly respected even if they were divided. In terms of the research results, there was a consensus regarding the high levels of resistance to CQ/SP; however, there were arguments among researchers as to what alternative drug was most suitable, given the evidence showing effectiveness of both ACT specifically (AL) and, AQ and AS. A donor respondent remarked that “Others questioned the neutrality of the research community, noting that some of the research teams had been funded by donors who did not support choosing AL as an alternative first-line drug. There were suspicions that the researchers were perhaps being influenced, as shown in the following quote:These researchers were funded by donors, and those particular donors had different views on possible alternative anti-malarials. When these researchers presented their results, there was a lot of disbelief initially. People made statements like `Anyway, if you look for the resistance you will find it’. We were using CQ/SP properly and no one was complaining until efficacy studies started reviewing the data. Then we started saying we have resistance to CQ/SP.” Donor respondent“Donors were also divided. While they were reportedly very influential, they seemed to rally behind the evidence generated from the studies that they supported, as shown in the following quote:I remember some donors were in for AQ and AS, while others were in for AL. So the MoH, as the chair at that time, listened to both sides as they debated. We listened to the pros and cons of the evidence they were giving and at the end we decided to opt for AL, based on the evidence we had and other considerations. Although AQ/AS was more affordable and its efficacy was more than 90%; artemether had an efficacy of 99% and in most areas 100%. We did not want to go through another costly policy change process in the near future so we opted for AL.” MoH respondent“The WHO reportedly had a strong influence on the MoH, as shown in the following quotes:The WHO has the greatest influence on health policy in the world with relation to disease areas like HIV, malaria, etc. So Uganda as a country will often look at the WHO for the decisions that it makes. The WHO has some of the best doctors in the world and they are looking at all of the evidence that is published, and weighing the different evidence to try and make decisions on what makes sense. So countries rely on the decision making ability of the WHO and use that in their own decision making.” Donor respondent“I remember our guidance was that any research that was conducted and funded by the WHO was most credible, because we rely on the WHO’s advice and take the WHO recommendations seriously.” MoH respondent.“the WHO provided technical assistance and each of the five combinations treatments recommended by WHO for the African Region at that time was considered as a possible alternative”  saying children were dying because we are treating them with CQ and not with ACTs. And then of course, there was a lot of push, given that many countries had started to use ACTs.” Researcher respondent“we don’t have systems for managing conflicts of interest. That’s the difference between the MoH and some research institutions like the Uganda National Academy of Health Sciences where I am a member. The first meeting is to prove that no one has a conflict of interest. We always have to sign and agree on the procedure.”In light of these external influences, respondents decried the lack of systems to manage conflicts of interest. A MoH respondent remarked that “Our present results identified a diverse group of stakeholders who played multiple roles and had varying levels of influence and support, which poses a challenge to evidence uptake. Woelk et al. documented similar challenges to evidence uptake in a case regarding efficacy of bed nets, where a diverse group of stakeholders differed in their interpretation and use of evidence, and aligned with different positions based on ideology and commercial interests . The preOur findings showed that donors, CSOs, the MoH, service providers, and researchers engaged in the role of evidence generation. Lack of evidence is a known barrier to KT ,39], wh, wh39], Although the literature has highlighted that CSOs have limited capacity for evidence generation , we founDissemination of evidence was performed by the MoH, parliamentarians, and opinion leaders at the national and local levels. In contrast, the literature highlighted that the media, knowledge brokers, and structures either within or external to the MoH undertake such evidence dissemination ,9]. Thi. Thi9]. …were saying the Global Fund grants should only be used for buying ACTs…”, while the MoH was relying on the Global Fund round 4 to fund implementation of the new policy. Challenges of donor dependency have also been reported in other countries. For instance, Cameroon’s national efforts to coordinate research were undermined . In. In53]. ez-Block  documentThe top management cadre of the MoH that was ultimately responsible for decision making was noted to be a weak and passive supporter, which could be explained by their limited involvement in the research processes. Panisset et al. documented successful experiences in Bangladesh, in which the involvement of the Directorate General of Health Services in the research process enhanced the uptake of zinc for use in diarrhoea management among young children . AnotherThe participation of researchers in the policy development process improved evidence uptake . AlthougIn the majority of countries, implementation of evidence is performed by the MoH, public and private service providers, and CSOs . HoweverIt has been reported that actors play different roles depending on the nature of the policy and their level of interest in a given issue ,27],,, CSOs weIn our present study, some respondents decried the lack of systems to manage conflicts of interest. Boyd and Bero emphasised the importance of identifying and managing conflict of interest in order to improve evidence uptake . The proStakeholders in KT play different roles and exert different levels of influence and support based on the nature of the policy and the evidence under consideration. This raises the need to map relevant stakeholders and to work out mechanisms for their involvement and for how evidence can be utilised by all in an objective manner. Provision of regular updates along research processes and targeted dissemination of evidence beyond in-country stakeholders may enhance inclusiveness and consensus building. Additionally, given the multiple array of stakeholders, there is a need to utilise mechanisms to manage conflict of interest.Our study has several strengths. Firstly, we interviewed a wide array of stakeholders and used multiple data collection methods, which provided a rich data set to use in assessing the roles and influence of stakeholders in evidence uptake. Secondly, the multidisciplinary nature of the research team helped to ensure objectivity in the data analysis and interpretation. Thirdly, interviews were conducted by the first author who is experienced with policy development in Uganda.The study also had several weaknesses. Firstly, recall bias may have impacted the accuracy of the responses, given the timing of the policy process and data collection. However, we noted consistency among the responses, suggesting that perhaps recall bias was not as much of a problem as might be anticipated. Secondly, with the exception of researchers, we considered stakeholders to be organisations/institutions/units. It should be noted that individuals may not necessarily represent the views of the institution in which they work; however, this was not explored in our study. Thirdly, it is possible that the stakeholders’ levels of influence and support in the uptake of evidence in policy could change at the different stages of policy development, but this was also not assessed in our study.Stakeholders played multiple roles in the uptake of evidence in the malaria treatment policy change in Uganda. The donors, MoH, service providers, and researchers engaged in the role of evidence generation. The MoH, parliamentarians, and opinion leaders at the national and local levels engaged in dissemination of evidence. The donors, MoH, researchers, and service providers through representation engaged in the uptake of evidence in policy development and implementation. Stakeholders exerted varying levels of support and influence for different reasons. For example, donors were influential due to their significant financial support, researchers were influential because they commanded respect, and the MoH was influential because the uptake of evidence and subsequent policy implementation heavily depended on them. It is noteworthy that all of the influential actors were divided regarding the best alternative antimalarial to adopt.Our findings suggest that the roles and influence of stakeholders in KT will vary given the nature of the policy and the available evidence. For a given KT process, mapping the relevant stakeholders and devising mechanism for their engagement and for resolving conflicts of interest will enhance the uptake of evidence in policy development. Additionally, structures and systems must be put in place to encourage community participation in research processes and decision making.Additional file 1: Documents reviewed: policies, guidelines, meeting minutes, position papers, research report. Details of milestones and list of documents reviewed. (DOC 52 KB)Additional file 2: Examples of how manifest content and thematic content analyses were performed. (a) Example of how manifest content analysis was performed. Details of how data was analysed to come with categories. (b) Example of how thematic content analysis was performed. Details of how data was analysed to develop themes. (ZIP 16 KB)Authors’ original file for figure 1Authors’ original file for figure 2Below are the links to the authors’ original submitted files for images.


Nonadherence and medication errors are common among patients with complex drug regimens. Apps for smartphones and tablets are effective for improving adherence, but they have not been tested in elderly patients with complex chronic conditions and who typically have less experience with this type of technology.The objective of this study was to design, implement, and evaluate a medication self-management app  for elderly patients taking multiple medications with the intention of improving adherence and safe medication use.A single-blind randomized controlled trial was conducted with a control and an experimental group (N=99) in Spain in 2013. The characteristics of ALICE were specified based on the suggestions of 3 nominal groups with a total of 23 patients and a focus group with 7 professionals. ALICE was designed for Android and iOS to allow for the personalization of prescriptions and medical advice, showing images of each of the medications (the packaging and the medication itself) together with alerts and multiple reminders for each alert. The randomly assigned patients in the control group received oral and written information on the safe use of their medications and the patients in the experimental group used ALICE for 3 months. Pre and post measures included rate of missed doses and medication errors reported by patients, scores from the 4-item Morisky Medication Adherence Scale (MMAS-4), level of independence, self-perceived health status, and biochemical test results. In the experimental group, data were collected on their previous experience with information and communication technologies, their rating of ALICE, and their perception of the level of independence they had achieved. The intergroup intervention effects were calculated by univariate linear models and ANOVA, with the pre to post intervention differences as the dependent variables.P<.001) and reported fewer missed doses of medication (P=.02). ALICE only helped to significantly reduce medication errors in patients with an initially higher rate of errors (P<.001). Patients with no experience with information and communication technologies reported better adherence (P<.001), fewer missed doses (P<.001), and fewer medication errors (P=.02). The mean satisfaction score for ALICE was 8.5 out of 10. In all, 45 of 51 patients (88%) felt that ALICE improved their independence in managing their medications.Data were obtained from 99 patients . Patients in the experimental group obtained better MMAS-4 scores . Chronic disorders are more common among elderly people. In Spain, persons older than 65 years have 3 chronic conditions on average . As manyThe complexity of treatment regimens can lead to an accumulation of medications, confusion because medications look similar , and a lack of coordination between the different levels of care. Patients’ intrinsic factors  have been also cited among the most common causes of nonadherence  and of iImproving treatment adherence is a priority because nonadherence to long-term treatments has a negative impact on the health of patients and leads to unnecessary expenditures ,14,15. TTaking the wrong dose or the wrong medication accounts for 5% of hospital admissions . In SpaiThe participation of patients in their own care ,27 has bUsage of apps for tablets and smartphones  designed to improve adherence has increased exponentially . HoweverThe objective of this study was to design, implement, and evaluate a medication self-management app in Spanish for elderly patients taking multiple medications by using tablets (Android or iOS) to increase adherence to treatment regimens and achieve safer use of drugs.A tablet-based medication self-management app  was designed to help patients to remember to take all their medications at the correct doses, distinguish between drugs to avoid confusions, avoid known potential interactions and common errors in use of the medications, and know how to properly store the medications. ALICE was also designed to remember doctors’ recommendations for healthy habits, such as physical exercise and diet. The app design was based on suggestions extracted from 3 nominal groups with a total of 23 patients and a focus group with 7 professionals (3 physicians and 4 pharmacists). The guide with questions for patients and professionals was drawn up considering the classification of medication errors in the study by Field et al  at the MThe tablet used was selected on the basis of the need for a device with an at least 7-inch easy-to-use touch screen, ensuring that users would only have to follow simple instructions and tap on some icons on the screen. Specifically, the BQ Verne Plus 3G with an liquid-crystal display (LCD) tactile screen was chosen for an Android and an iPad 2 with Wi-Fi and 3G for the iOS.The ALICE app was designed to work with personalized prescriptions and recommendations given to patients, with a function making it possible to store details of all their prescriptions and related instructions, as well as images for each of the medications , and recommendations of the various different doctors seeing the same patient. A second function established a customized system of alerts and reminders for a given alert, to remind patients when to take their medications and to put into practice healthy habits, using the approaches suggested by participants in the nominal groups . Lastly, a third function was to enable monitoring of the level of adherence to the prescriptions and medical advice, the tablet connecting via a wireless or 3G network with the study monitoring system, with the health care provider and with a relative or caregiver when authorized by the patient .When it is time to take a medication, an alarm sounds and the patient accesses the main menu of the app. Displayed is the name of the medication, dose, time, and any warnings of how the patient should take the medication (if applicable). The patient may consult his/her medication anytime. The medication usually is associated with breakfast, lunch, snack, or dinner daily. ALICE follows this normal use. The ALICE app reports medications the patient must take in a day and reports medicines that the patient has forgotten to take that day.Once the tool was designed and before the experimental phase, we assessed its feasibility, verifying that all the app characteristics proposed in the previous phase were included in the design process. For this purpose, 8 elderly patients assessed the user-friendliness of the tool, its degree of intuitiveness, whether the font was sufficiently large, the contrast of the text and images, and the quality of the photographs. Identified problems were the low volume of alerts and a proposal to simplify the system for taking photos of drugs to include images on ALICE. Both problems were solved.The ALICE app has the following features: a user-friendly interface to introduce text and images; various medication reminder alerts and messages for patients, including sounds or flashing and also messages sent to relatives or caregivers; and a complete list for the caregivers of all prescriptions regardless of the number of doctors involved including a summary of patient adherence behavior.To evaluate ALICE we opted for a single-blind experimental design with 2 groups  and pre and post assessments using a randomized controlled trial (NCT02071498). Patients were randomly assigned to the control or experimental group. The control group was composed of participants who did not use ALICE, and the experimental group was composed of people who used this tool for 3 months. To maintain the blinding and be able to link the pre and post measurements, patients were assigned codes based on their date of birth and initials.We randomly selected 102 patients with a digital medical history from 13 health centers in the health districts of Alicante and Bilbao. We defined the following inclusion criteria for the study: multimorbid patients taking multiple medications, older than 65 years, with a Barthel  score ofMorisky Medication Adherence Scale (MMAS-4), as well as self-perceived health status, the number of doctors seen, whether they used a physical pillbox, and who organized their medication (over the previous 3 months). Additionally, we recorded data on the sociodemographic characteristics of participants, namely sex, age, and civil status. Those in the control group received oral and written information regarding the main risks related to their medications and the most common errors of patients when taking medications. Participants in the experimental group were given a BQ tablet or an iPad with the ALICE app installed and personalized according to the medications they had been prescribed as listed in their medical record. Patients in this group attended individual sessions of up to 2 hours to be shown how to use the app. During the study period, patients from the experimental group had a contact telephone number for any query regarding the use of the tablet or the app.All participating patients completed a questionnaire to assess the rates of missed doses and of medication errors, and adherence to treatment measured by the 4-item Three months later, the measurements made preintervention were repeated and extra information was collected regarding treatment adherence based on the data provided by ALICE (post). Additionally, patients from the experimental group answered a series of questions to ascertain whether they, prior to the study, had experience with using tablets, smartphones, mobile phones, and computers. They were also asked to evaluate ALICE , whether they would recommend the app to relatives, friends, and acquaintances, and their perception of the degree of independence they had achieved because of ALICE.t test. In all cases, we checked that the assumptions of the statistical tests used were met. We considered P<.05 to be statistically significant.To assess the effectiveness of ALICE, we built various univariate linear models. Where there were intergroup differences in preintervention measurements, we performed univariate linear model and ANOVA tests, using as the dependent variables the differences between the pre and post intervention measurements in MMAS-4 scores, self-perceived health status, levels of glycated hemoglobin (HbA1), low-density lipoprotein (LDL) cholesterol, blood pressure, number of medication errors, and missed doses related to medication reported by patients. Allocation to the experimental or control group was considered as the independent variable. In the experimental group, we carried out Pearson correlation analysis between MMAS-4 scores and treatment adherence assessed objectively by the number of alerts that had not been acknowledged or had been acknowledged late (data provided by ALICE). Additionally, to allow for the potential effect of the level of experience of patients with information and communication technology (ICT), we compared the pre and post intervention measurements in the experimental group adjusting for the effect of familiarity with ICTs. We compared the rating of ALICE by patients in the experimental group with and without ICT experience by using the chi-square test and their level of satisfaction with ALICE  by using the Student According to the 23 patients and 7 health professionals that participated in the qualitative research process, the design of the ALICE app had to satisfy the following criteria: it needed be easy to use, have sufficiently large font size, include photographs of the medications, and offer a large variety of alerts to be set to suit the preferences of patients with a menu enabling patients to easily adjust the alerts to be associated with their breakfast, lunch, dinner, and other meals and snacks, or other daily activities occurring at regular times. For each alert, it had to be possible to program up to 5 reminders and include information to avoid confusion between medicines, and advice on how to take the medication and how to store it properly. It was important to include all the medications patients were on regardless of the prescribing doctor and include automatic reminders of other medical recommendations . Further, ALICE had to record the level of treatment adherence, send short message service (SMS) text messages to relatives or caregivers if patients failed to adhere to treatments, and alert a monitoring system in the event of a malfunction. Lastly, ALICE had to provide information about all the medications taken by patients, regardless of the number of prescribing doctors, and send reports on medication alerts that were not acknowledged so that when patients attended appointments, their doctors would know the extent to which they were adhering to treatments prescribed.This study was carried out between June 2012 and May 2013. Data were obtained from 99 patients . Three patients in the control group declined to participate . The chaPatients from the experimental group reported greater treatment adherence (measured using the MMAS-4) and a lower rate of missed doses at the end of the study . SpecifiThe patients in the control and experimental groups had similar levels of glycated hemoglobin and blood pressure and similar self-perceived health status before and after the study. However, the pre-post measurements of cholesterol were statistically different; levels increased by 5% compared to before the study .P=.04). This result showed the positive and significant relationship between the adherence of the MMAS-4 and the information provided by ALICE on the level of patient compliance.A total of 31,383 medication alerts were programmed. Between Monday and Sunday, 3293 (10.49%) alerts were not been dealt with and 2978 (9.49%) were dealt with after the first reminder. The Pearson correlation coefficient between the number of alerts that were not dealt with and the MMAS-4 score was .3  required individual support once they joined the study to solve problems related to the use of ALICE. Most of these  concerned charging the battery and restarting the system .The level of satisfaction with ALICE  was similar in those with some and with no previous ICT experience . The meaTreatment adherence was higher in patients in the experimental group than in the control group. It is important to highlight that the ALICE app helped to solve a common problem in elderly patients; namely, remembering whether they have taken their medication. By using ALICE, the number of errors decreased, although the patients who benefited in this respect were those who previously made the most errors. Our data suggest that ALICE does contribute to reducing systematic errors, but not all medication errors.The self-perceived health status, levels of glycated hemoglobin, and blood pressure remained similar from the beginning to the end of the study, and although cholesterol levels increased, the changes were not clinically relevant. That is, ALICE did not improve the clinical status of patients; however, 3 months may not be long enough to observe differences. It did, however, improve patients’ perception of independence in the management of their medications.Elderly patients with complex drug regimens, even those without previous experience in the use of tablets, smartphones, and computers, or who had never used the Internet, were found to be capable of effectively using an app designed to improve safe medication use. ALICE was designed to cope with attrition of users using these devices. ALICE was used daily and only 1 patient left the study because of a problem with the tablet and not with ALICE.This is one of the few experimental studies assessing the effectiveness of a virtual pillbox for tablets and smartphones targeted to elderly patients with multiple health problems. The design of ALICE took into account the findings of other studies, but was based on the views and preferences of the target patients and the experience of the primary care and pharmacy personnel caring for them. The suggestion to assess the usability during the development of this intervention was also applied . This apTraditional pillboxes improve treatment adherence, but are only useful in the case of solid dosage medications . FurtherThe level of adherence, assessed in 3 different ways , was good in all cases compared to the mean nonadherence figures reported for chronic patients in general  . Further, they can be adapted to the habits and lifestyle of patients, to make it easier and simpler for them to take their medication because it is known that these factors are the main cause of nonadherence. These issues have been taken into account in the design of ALICE and it seems this app does have a beneficial effect on the level of adherence and patients perceive that it improves the way they take their medication.Rates of medication errors are particularly high in patients on multiple medications ,12,27. OMMAS-4 overestimates adherence, yielding higher rates than those obtained from pill counts. This study did not consider medication reconciliation. In some cases, if there has been inappropriate prescribing, following treatment regimens could pose a risk. This app only addresses unintentional nonadherence. In the event of a patient being reluctant or opposed to taking a certain medicine [The small number of participants and the number of months using ALICE affected our ability to detect differences between the group using the ALICE app and the control group  as well as our ability to generalize the results. This type of app does not address the issue of where to store medication at home to have it accessible when it should be taken. The data collected do not include details about the number of drugs to be taken daily. No count was made of pills nor did we use any other system to check if patients actually took any medication after acknowledging the alert. Further, we cannot be sure that they took the correct dose or even the correct drug. We do not know whether ALICE would continue to be effective in the longer term. This is important because a notable reason patients cite for stopping taking medications is the feeling that they are not working for them. There is some evidence that the medicine  (this knMost apps have been designed for patients with less complex health problems and/or experience with ICTs. This study should change the expectations of developers and mobile phone companies, encouraging them to develop apps and devices suited to older patients with multimorbidity who are normally excluded from studies thought to be too complex because such tools could improve the capacity of these individuals to manage their illnesses.Glucose monitors and other devices currently in use in telemedicine programs could have add-ons to help individual patients use their medications more safely. Such devices should not only include alerts for medicines, but also reminders of how to put advice on healthy habits into practice.Further studies on virtual pillboxes for tablets and smartphones could explore whether adherence can be improved by personalization of treatment regimens as suggested by other authors . SpecifiALICE and other similar apps have a broad potential not only for patients, but also for professionals because they can provide useful information about how patients adapt the therapeutic regimen to their lifestyle. Future studies could explore how to improve physician recommendations to increase adherence to treatment based on personalized information.