Summary Background Although structured psychological treatments are recommended as first-line interventions for depression, only a small fraction of people globally receive these treatments because ...of poor access in routine primary care. We assessed the effectiveness and cost-effectiveness of a brief psychological treatment (Healthy Activity Program HAP) for delivery by lay counsellors to patients with moderately severe to severe depression in primary health-care settings. Methods In this randomised controlled trial, we recruited participants aged 18–65 years scoring more than 14 on the Patient Health Questionnaire 9 (PHQ-9) indicating moderately severe to severe depression from ten primary health centres in Goa, India. Pregnant women or patients who needed urgent medical attention or were unable to communicate clearly were not eligible. Participants were randomly allocated (1:1) to enhanced usual care (EUC) alone or EUC combined with HAP in randomly sized blocks (block size four to six two to four for men), stratified by primary health centre and sex, and allocation was concealed with use of sequential numbered opaque envelopes. Physicians providing EUC were masked. Primary outcomes were depression symptom severity on the Beck Depression Inventory version II and remission from depression (PHQ-9 score of <10) at 3 months in the intention-to-treat population, assessed by masked field researchers. Secondary outcomes were disability, days unable to work, behavioural activation, suicidal thoughts or attempts, intimate partner violence, and resource use and costs of illness. We assessed serious adverse events in the per-protocol population. This trial is registered with the ISRCTN registry, number ISRCTN95149997. Findings Between Oct 28, 2013, and July 29, 2015, we enrolled and randomly allocated 495 participants (247 50% to the EUC plus HAP group two of whom were subsequently excluded because of protocol violations and 248 50% to the EUC alone group), of whom 466 (95%) completed the 3 month primary outcome assessment (230 49% in the EUC plus HAP group and 236 51% in the EUC alone group). Participants in the EUC plus HAP group had significantly lower symptom severity (Beck Depression Inventory version II in EUC plus HAP group 19·99 SD 15·70 vs 27·52 13·26 in EUC alone group; adjusted mean difference −7·57 95% CI −10·27 to −4·86; p<0·0001) and higher remission (147 64% of 230 had a PHQ-9 score of <10 in the HAP plus EUC group vs 91 39% of 236 in the EUC alone group; adjusted prevalence ratio 1·61 1·34–1·93) than did those in the EUC alone group. EUC plus HAP showed better results than did EUC alone for the secondary outcomes of disability (adjusted mean difference −2·73 –4·39 to −1·06; p=0·001), days out of work (−2·29 –3·84 to −0·73; p=0·004), intimate partner physical violence in women (0·53 0·29–0·96; p=0·04), behavioural activation (2·17 1·34–3·00; p<0·0001), and suicidal thoughts or attempts (0·61 0·45–0·83; p=0·001). The incremental cost per quality-adjusted life-year gained was $9333 (95% CI 3862–28 169; 2015 international dollars), with an 87% chance of being cost-effective in the study setting. Serious adverse events were infrequent and similar between groups (nine 4% in the EUC plus HAP group vs ten 4% in the EUC alone group; p=1·00). Interpretation HAP delivered by lay counsellors plus EUC was better than EUC alone was for patients with moderately severe to severe depression in routine primary care in Goa, India. HAP was readily accepted by this previously untreated population and was cost-effective in this setting. HAP could be a key strategy to reduce the treatment gap for depressive disorders, the leading mental health disorder worldwide. Funding Wellcome Trust.
To carry out an economic evaluation of a task-shifting intervention for the treatment of depressive and anxiety disorders in primary-care settings in Goa, India.
Cost-utility and cost-effectiveness ...analyses based on generalized linear models were performed within a trial set in 24 public and private primary-care facilities. Subjects were randomly assigned to an intervention or a control arm. Eligible subjects in the intervention arm were given psycho-education, case management, interpersonal psychotherapy and/or antidepressants by lay health workers. Subjects in the control arm were treated by physicians. The use of health-care resources, the disability of each subject and degree of psychiatric morbidity, as measured by the Revised Clinical Interview Schedule, were determined at 2, 6 and 12 months.
Complete data, from all three follow-ups, were collected from 1243 (75.4%) and 938 (81.7%) of the subjects enrolled in the study facilities from the public and private sectors, respectively. Within the public facilities, subjects in the intervention arm showed greater improvement in all the health outcomes investigated than those in the control arm. Time costs were also significantly lower in the intervention arm than in the control arm, whereas health system costs in the two arms were similar. Within the private facilities, however, the effectiveness and costs recorded in the two arms were similar.
Within public primary-care facilities in Goa, the use of lay health workers in the care of subjects with common mental disorders was not only cost-effective but also cost-saving.
Many sub-Saharan countries, including Ghana, have introduced policies to provide free medical care to pregnant women. The impact of these policies, particularly on access to health services among the ...poor, has not been evaluated using rigorous methods, and so the empirical basis for defending these policies is weak. In Ghana, a recent report also cast doubt on the current mechanism of delivering free care--the National Health Insurance Scheme. Longitudinal surveillance data from two randomized controlled trials conducted in the Brong Ahafo Region provided a unique opportunity to assess the impact of Ghana's policies.
We used time-series methods to assess the impact of Ghana's 2005 policy on free delivery care and its 2008 policy on free national health insurance for pregnant women. We estimated their impacts on facility delivery and insurance coverage, and on socioeconomic differentials in these outcomes after controlling for temporal trends and seasonality.
Facility delivery has been increasing significantly over time. The 2005 and 2008 policies were associated with significant jumps in coverage of 2.3% (p = 0.015) and 7.5% (p<0.001), respectively after the policies were introduced. Health insurance coverage also jumped significantly (17.5%, p<0.001) after the 2008 policy. The increases in facility delivery and insurance were greatest among the poorest, leading to a decline in socioeconomic inequality in both outcomes.
Providing free care, particularly through free health insurance, has been effective in increasing facility delivery overall in the Brong Ahafo Region, and especially among the poor. This finding should be considered when evaluating the impact of the National Health Insurance Scheme and in supporting the continuation and expansion of free delivery care.
Mobile health (mHealth) describes the use of portable electronic devices with software applications to provide health services and manage patient information. With approximately 5 billion mobile ...phone users globally, opportunities for mobile technologies to play a formal role in health services, particularly in low- and middle-income countries, are increasingly being recognized. mHealth can also support the performance of health care workers by the dissemination of clinical updates, learning materials, and reminders, particularly in underserved rural locations in low- and middle-income countries where community health workers deliver integrated community case management to children sick with diarrhea, pneumonia, and malaria.
Our aim was to conduct a thematic review of how mHealth projects have approached the intersection of cellular technology and public health in low- and middle-income countries and identify the promising practices and experiences learned, as well as novel and innovative approaches of how mHealth can support community health workers.
In this review, 6 themes of mHealth initiatives were examined using information from peer-reviewed journals, websites, and key reports. Primary mHealth technologies reviewed included mobile phones, personal digital assistants (PDAs) and smartphones, patient monitoring devices, and mobile telemedicine devices. We examined how these tools could be used for education and awareness, data access, and for strengthening health information systems. We also considered how mHealth may support patient monitoring, clinical decision making, and tracking of drugs and supplies. Lessons from mHealth trials and studies were summarized, focusing on low- and middle-income countries and community health workers.
The review revealed that there are very few formal outcome evaluations of mHealth in low-income countries. Although there is vast documentation of project process evaluations, there are few studies demonstrating an impact on clinical outcomes. There is also a lack of mHealth applications and services operating at scale in low- and middle-income countries. The most commonly documented use of mHealth was 1-way text-message and phone reminders to encourage follow-up appointments, healthy behaviors, and data gathering. Innovative mHealth applications for community health workers include the use of mobile phones as job aides, clinical decision support tools, and for data submission and instant feedback on performance.
With partnerships forming between governments, technologists, non-governmental organizations, academia, and industry, there is great potential to improve health services delivery by using mHealth in low- and middle-income countries. As with many other health improvement projects, a key challenge is moving mHealth approaches from pilot projects to national scalable programs while properly engaging health workers and communities in the process. By harnessing the increasing presence of mobile phones among diverse populations, there is promising evidence to suggest that mHealth can be used to deliver increased and enhanced health care services to individuals and communities, while helping to strengthen health systems.
Early childhood development is key to achieving the Sustainable Development Goals and can be negatively influenced by many different adversities including violence in the home, neglect, abuse and ...parental ill-health. We set out to quantify the extent to which multiple adversities are associated with impaired early childhood growth & development.
This was a substudy of the SPRING cluster randomised controlled trial covering the whole population of 120 villages of rural India. We assessed all children born from 18 June 2015 for adversities in the first year of life and summed these to make a total cumulative adversity score, and four subscale scores. We assessed the association of each of these with weight-for-age z-score, length-for-age z-score, and the motor, cognitive and language developmental scales of the Bayley Scales of Infant Development III assessed at 18 months.
We enrolled 1726 children soon after birth and assessed 1273 of these at both 12 and 18 months of age. There were consistent and strongly negative relationships between all measures of childhood adversity and all five child growth & development outcome measures at 18 months of age. For the Bayley motor scale, each additional adversity was associated with a 1.1 point decrease (95%CI -1.3, -0.9); for the cognitive scales this was 0.8 points (95%CI -1.0, -0.6); and for language this was 1.4 points (95%CI -1.9, -1.1). Similarly for growth, each additional adversity was associated with a -0.09 change in weight-for-age z-score (-0.11, -0.06) and -0.12 change in height-for-age z-score (-0.14, -0.09).
Our results are the first from a large population-based study in a low/middle-income country to show that each increase in adversity in multiple domains increases risk to child growth and development at a very early age. There is an urgent need to act to improve these outcomes for young children in LMICs and these findings suggest that Early Childhood programmes should prioritise early childhood adversity because of its impact on developmental inequities from the very start.
To evaluate quality of routine and emergency intrapartum and postnatal care using a health facility assessment, and to estimate "effective coverage" of skilled attendance in Brong Ahafo, Ghana.
We ...conducted an assessment of all 86 health facilities in seven districts in Brong Ahafo. Using performance of key signal functions and the availability of relevant drugs, equipment and trained health professionals, we created composite quality categories in four dimensions: routine delivery care, emergency obstetric care (EmOC), emergency newborn care (EmNC) and non-medical quality. Linking the health facility assessment to surveillance data we estimated "effective coverage" of skilled attendance as the proportion of births in facilities of high quality.
Delivery care was offered in 64/86 facilities; only 3-13% fulfilled our requirements for the highest quality category in any dimension. Quality was lowest in the emergency care dimensions, with 63% and 58% of facilities categorized as "low" or "substandard" for EmOC and EmNC, respectively. This implies performing less than four EmOC or three EmNC signal functions, and/or employing less than two skilled health professionals, and/or that no health professionals were present during our visit. Routine delivery care was "low" or "substandard" in 39% of facilities, meaning 25/64 facilities performed less than six routine signal functions and/or had less than two skilled health professionals and/or less than one midwife. While 68% of births were in health facilities, only 18% were in facilities with "high" or "highest" quality in all dimensions.
Our comprehensive facility assessment showed that quality of routine and emergency intrapartum and postnatal care was generally low in the study region. While coverage with facility delivery was 68%, we estimated "effective coverage" of skilled attendance at 18%, thus revealing a large "quality gap." Effective coverage could be a meaningful indicator of progress towards reducing maternal and newborn mortality.
Summary Background Achievement of global health goals will require assessment of progress not only nationally but also for population subgroups. We aimed to assess how the magnitude of socioeconomic ...inequalities in health changes in relation to different rates of national progress in coverage of interventions for the health of mothers and children. Methods We assessed coverage in low-income and middle-income countries for which two Demographic Health Surveys or Multiple Indicator Cluster Surveys were available. We calculated changes in overall coverage of skilled birth attendants, measles vaccination, and a composite coverage index, and examined coverage of a newly introduced intervention, use of insecticide-treated bednets by children. We stratified coverage data according to asset-based wealth quintiles, and calculated relative and absolute indices of inequality. We adjusted correlation analyses for time between surveys and baseline coverage levels. Findings We included 35 countries with surveys done an average of 9·1 years apart. Pro-rich inequalities were very prevalent. We noted increased coverage of skilled birth attendants, measles vaccination, and the composite index in most countries from the first to the second survey, while inequalities were reduced. Rapid changes in overall coverage were associated with improved equity. These findings were not due to a capping effect associated with limited scope for improvement in rich households. For use of insecticide-treated bednets, coverage was high for the richest households, but countries making rapid progress did almost as well in reaching the poorest groups. National increases in coverage were primarily driven by how rapidly coverage increased in the poorest quintiles. Interpretation Equity should be accounted for when planning the scaling up of interventions and assessing national progress. Funding Bill & Melinda Gates Foundation; World Bank; Governments of Australia, Brazil, Canada, Norway, Sweden, and UK.
The Healthy Activity Programme (HAP), a brief behavioural intervention delivered by lay counsellors, enhanced remission over 3 months among primary care attendees with depression in peri-urban and ...rural settings in India. We evaluated the sustainability of the effects after treatment termination, the cost-effectiveness of HAP over 12 months, and the effects of the hypothesized mediator of activation on clinical outcomes.
Primary care attendees aged 18-65 years screened with moderately severe to severe depression on the Patient Health Questionnaire 9 (PHQ-9) were randomised to either HAP plus enhanced usual care (EUC) (n = 247) or EUC alone (n = 248), of whom 95% completed assessments at 3 months, and 91% at 12 months. Primary outcomes were severity on the Beck Depression Inventory-II (BDI-II) and remission on the PHQ-9. HAP participants maintained the gains they showed at the end of treatment through the 12-month follow-up (difference in mean BDI-II score between 3 and 12 months = -0.34; 95% CI -2.37, 1.69; p = 0.74), with lower symptom severity scores than participants who received EUC alone (adjusted mean difference in BDI-II score = -4.45; 95% CI -7.26, -1.63; p = 0.002) and higher rates of remission (adjusted prevalence ratio aPR = 1.36; 95% CI 1.15, 1.61; p < 0.009). They also fared better on most secondary outcomes, including recovery (aPR = 1.98; 95% CI 1.29, 3.03; p = 0.002), any response over time (aPR = 1.45; 95% CI 1.27, 1.66; p < 0.001), higher likelihood of reporting a minimal clinically important difference (aPR = 1.42; 95% CI 1.17, 1.71; p < 0.001), and lower likelihood of reporting suicidal behaviour (aPR = 0.71; 95% CI 0.51, 1.01; p = 0.06). HAP plus EUC also had a marginal effect on WHO Disability Assessment Schedule score at 12 months (aPR = -1.58; 95% CI -3.33, 0.17; p = 0.08); other outcomes (days unable to work, intimate partner violence toward females) did not statistically significantly differ between the two arms. Economic analyses indicated that HAP plus EUC was dominant over EUC alone, with lower costs and better outcomes; uncertainty analysis showed that from this health system perspective there was a 95% chance of HAP being cost-effective, given a willingness to pay threshold of Intl$16,060-equivalent to GDP per capita in Goa-per quality-adjusted life year gained. Patient-reported behavioural activation level at 3 months mediated the effect of the HAP intervention on the 12-month depression score (β = -2.62; 95% CI -3.28, -1.97; p < 0.001). Serious adverse events were infrequent, and prevalence was similar by arm. We were unable to assess possible episodes of remission and relapse that may have occurred between our outcome assessment time points of 3 and 12 months after randomisation. We did not account for or evaluate the effect of mediators other than behavioural activation.
HAP's superiority over EUC at the end of treatment was largely stable over time and was mediated by patient activation. HAP provides better outcomes at lower costs from a perspective covering publicly funded healthcare services and productivity impacts on patients and their families.
ISRCTN registry ISRCTN95149997.
Summary Background Depression and anxiety disorders are common mental disorders worldwide. The MANAS trial aimed to test the effectiveness of an intervention led by lay health counsellors in primary ...care settings to improve outcomes of people with these disorders. Methods In this cluster randomised trial, primary care facilities in Goa, India, were assigned (1:1) by computer-generated randomised sequence to intervention or control (enhanced usual care) groups. All adults who screened positive for common mental disorders were eligible. The collaborative stepped-care intervention offered case management and psychosocial interventions, provided by a trained lay health counsellor, supplemented by antidepressant drugs by the primary care physician and supervision by a mental health specialist. The research assessor was masked. The primary outcome was recovery from common mental disorders as defined by the International Statistical Classification of Diseases and Related Health Problems—10th revision (ICD-10) at 6 months. This study is registered with ClinicalTrials.gov , number NCT00446407. Findings 24 study clusters, with an equal proportion of public and private facilities, were randomised equally between groups. 1160 of 1360 (85%) patients in the intervention group and 1269 of 1436 (88%) in the control group completed the outcome assessment. Patients with ICD-10-confirmed common mental disorders in the intervention group were more likely to have recovered at 6 months than were those in the control group (n=620 65·0% vs 553 52·9%; risk ratio 1·22, 95% CI 1·00–1·47; risk difference=12·1%, 95% CI 1·6%–22·5%). The intervention had strong evidence of an effect in public facility attenders (369 65·9% vs 267 42·5%, risk ratio 1·55, 95% CI 1·02–2·35) but no evidence for an effect in private facility attenders (251 64·1% vs 286 65·9%, risk ratio 0·95, 0·74–1·22). There were three deaths and four suicide attempts in the collaborative stepped-care group and six deaths and six suicide attempts in the enhanced usual care group. None of the deaths were from suicide. Interpretation A trained lay counsellor-led collaborative care intervention can lead to an improvement in recovery from CMD among patients attending public primary care facilities. Funding The Wellcome Trust.
Summary We reviewed interventions that affect maternal and child undernutrition and nutrition-related outcomes. These interventions included promotion of breastfeeding; strategies to promote ...complementary feeding, with or without provision of food supplements; micronutrient interventions; general supportive strategies to improve family and community nutrition; and reduction of disease burden (promotion of handwashing and strategies to reduce the burden of malaria in pregnancy). We showed that although strategies for breastfeeding promotion have a large effect on survival, their effect on stunting is small. In populations with sufficient food, education about complementary feeding increased height-for-age Z score by 0·25 (95% CI 0·01–0·49), whereas provision of food supplements (with or without education) in populations with insufficient food increased the height-for-age Z score by 0·41 (0·05–0·76). Management of severe acute malnutrition according to WHO guidelines reduced the case-fatality rate by 55% (risk ratio 0·45, 0·32–0·62), and recent studies suggest that newer commodities, such as ready-to-use therapeutic foods, can be used to manage severe acute malnutrition in community settings. Effective micronutrient interventions for pregnant women included supplementation with iron folate (which increased haemoglobin at term by 12 g/L, 2·93–21·07) and micronutrients (which reduced the risk of low birthweight at term by 16% (relative risk 0·84, 0·74–0·95). Recommended micronutrient interventions for children included strategies for supplementation of vitamin A (in the neonatal period and late infancy), preventive zinc supplements, iron supplements for children in areas where malaria is not endemic, and universal promotion of iodised salt. We used a cohort model to assess the potential effect of these interventions on mothers and children in the 36 countries that have 90% of children with stunted linear growth. The model showed that existing interventions that were designed to improve nutrition and prevent related disease could reduce stunting at 36 months by 36%; mortality between birth and 36 months by about 25%; and disability-adjusted life-years associated with stunting, severe wasting, intrauterine growth restriction, and micronutrient deficiencies by about 25%. To eliminate stunting in the longer term, these interventions should be supplemented by improvements in the underlying determinants of undernutrition, such as poverty, poor education, disease burden, and lack of women's empowerment.
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