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Background\ud Randomised controlled trials (RCTs) are widely used for establishing evidence of the effectiveness of interventions, yet public health interventions are often complex, posing specific challenges for RCTs. Although there is increasing recognition that qualitative methods can and should be integrated into RCTs, few frameworks and practical guidance highlight which qualitative methods should be integrated and for what purposes. As a result, qualitative methods are often poorly or haphazardly integrated into existing trials, and researchers rely heavily on interviews and focus group discussions. To improve current practice, we propose a framework for innovative qualitative research methods that can help address the challenges of RCTs for complex public health interventions.\ud \ud Methods\ud We used a stepped approach to develop a practical framework for researchers. This consisted of (1) a systematic review of the innovative qualitative methods mentioned in the health literature, (2) in-depth interviews with 23 academics from different methodological backgrounds working on RCTs of public health interventions in 11 different countries, and (3) a framework development and group consensus-building process.\ud \ud Results\ud The findings are presented in accordance with the CONSORT (Consolidated Standards of Reporting Trials) Statement categories for ease of use. We identify the main challenges of RCTs for public health interventions alongside each of the CONSORT categories, and potential innovative qualitative methods that overcome each challenge are listed as part of a Framework for the Integration of Innovative Qualitative Methods into RCTs of Complex Health Interventions. Innovative qualitative methods described in the interviews include rapid ethnographic appraisals, document analysis, diary methods, interactive voice responses and short message service, community mapping, spiral walks, pair interviews and visual participatory analysis.\ud \ud Conclusions\ud The findings of this study point to the usefulness of observational and participatory methods for trials of complex public health interventions, offering a novel contribution to the broader literature about the need for mixed methods approaches. Integrating a diverse toolkit of qualitative methods can enable appropriate adjustments to the intervention or process (or both) of data collection during RCTs, which in turn can create more sustainable and effective interventions. However, such integration will require a cultural shift towards the adoption of method-neutral research approaches, transdisciplinary collaborations, and publishing regimes.

Background:Socioeconomic inequalities in neonatal mortality are substantial in many developing countries. Little is known about how to address this problem. Trials in Asia and Africa have shown strong impacts on neonatal mortality of a participatory learning and action intervention with women's groups. Whether this intervention also reduces mortality inequalities remains unknown. We describe the equity impact of this women's groups intervention on the neonatal mortality rate (NMR) across socioeconomic strata. Methods:We conducted a meta-analysis of all four participatory women's group interventions that were shown to be highly effective in cluster randomized trials in India, Nepal, Bangladesh and Malawi. We estimated intervention effects on NMR and health behaviours for lower and higher socioeconomic strata using random effects logistic regression analysis. Differences in effect between strata were tested. Results:Analysis of 69120 live births and 2505 neonatal deaths shows that the intervention strongly reduced the NMR in lower (50-63% reduction depending on the measure of socioeconomic position used) and higher (35-44%) socioeconomic strata. The intervention did not show evidence of 'elite-capture': among the most marginalized populations, the NMR in intervention areas was 63% lower [95% confidence interval (CI) 48-74%] than in control areas, compared with 35% (95% CI: 15-50%) lower among the less marginalized in the last trial year ( P -value for difference between most/less marginalized: 0.009). The intervention strongly improved home care practices, with no systematic socioeconomic differences in effect. Conclusions:Participatory women's groups with high population coverage benefit the survival chances of newborns from all socioeconomic strata, and perhaps especially those born into the most deprived households.

To explore the factors affecting intra-household food allocation practices to inform the development of interventions to prevent low birth weight in rural plains of Nepal. Qualitative methodology using purposive sampling to explore the barriers and facilitating factors to improved maternal nutrition. Rural Dhanusha District, Nepal. We purposively sampled twenty-five young daughters-in-law from marginalised groups living in extended families and conducted semi-structured interviews with them. We also conducted one focus group discussion with men and one with female community health volunteers who were mothers-in-law. Gender and age hierarchies were important in household decision making. The mother-in-law was responsible for ensuring that a meal was provided to productive household members. The youngest daughter-in-law usually cooked last and ate less than other family members, and showed respect for other family members by cooking only when permitted and deferring to others' choice of food. There were limited opportunities for these women to snack between main meals. Daughters-in-law' movement outside the household was restricted and therefore family members perceived that their nutritional need was less. Poverty affected food choice and families considered cost before nutritional value. It is important to work with the whole household, particularly mothers-in-law, to improve maternal nutrition. We present five barriers to behaviour change: poverty; lack of knowledge about cheap nutritional food, the value of snacking, and cheap nutritional food that does not require cooking; sharing food; lack of self-confidence; and deference to household guardians. We discuss how we have targeted our interventions to develop knowledge, discuss strategies to overcome barriers, engage mothers-in-law, and build the confidence and social support networks of pregnant women.

Household Air Pollution (HAP) from biomass cooking fuels is a major cause of morbidity and mortality in low-income settings worldwide. In Nepal the use of open stoves with solid biomass fuels is the primary method of domestic cooking. To assess patterns of domestic air pollution we performed continuous measurement of carbon monoxide (CO) and particulate Matter (PM2.5) in 12 biomass fuel households in Janakpur, Nepal. We measured kitchen PM2.5 and CO concentrations at one-minute intervals for an approximately 48-h period using the TSI DustTrak II 8530/SidePak AM510 (TSI Inc, St. Paul MN, USA) or EL-USB-CO data logger (Lascar Electronics, Erie PA, USA) respectively. We also obtained information regarding fuel, stove and kitchen characteristics and cooking activity patterns. Household cooking was performed in two daily sessions (median total duration 4 h) with diurnal variability in pollutant concentrations reflecting morning and evening cooking sessions and peak concentrations associated with fire-lighting. We observed a strong linear relationship between PM2.5 measurements obtained by co-located photometric and gravimetric monitoring devices, providing local calibration factors of 4.9 (DustTrak) and 2.7 (SidePak). Overall 48-h average CO and PM2.5 concentrations were 5.4 (SD 4.3) ppm (12 households) and 417.6 (SD 686.4) μg/m(3) (8 households), respectively, with higher average concentrations associated with cooking and heating activities. Overall average PM2.5 concentrations and peak 1-h CO concentrations exceeded WHO Indoor Air Quality Guidelines. Average hourly PM2.5 and CO concentrations were moderately correlated (r = 0.52), suggesting that CO has limited utility as a proxy measure for PM2.5 exposure assessment in this setting. Domestic indoor air quality levels associated with biomass fuel combustion in this region exceed WHO Indoor Air Quality standards and are in the hazardous range for human health.

In 2013, an estimated 2.8 million newborns died and 2.7 million were stillborn. A much greater number suffer from long term impairment associated with preterm birth, intrauterine growth restriction, congenital anomalies, and perinatal or infectious causes. With the approaching deadline for the achievement of the Millennium Development Goals (MDGs) in 2015, there was a need to set the new research priorities on newborns and stillbirth with a focus not only on survival but also on health, growth and development. We therefore carried out a systematic exercise to set newborn health research priorities for 2013-2025.We used adapted Child Health and Nutrition Research Initiative (CHNRI) methods for this prioritization exercise. We identified and approached the 200 most productive researchers and 400 program experts, and 132 of them submitted research questions online. These were collated into a set of 205 research questions, sent for scoring to the 600 identified experts, and were assessed and scored by 91 experts.Nine out of top ten identified priorities were in the domain of research on improving delivery of known interventions, with simplified neonatal resuscitation program and clinical algorithms and improved skills of community health workers leading the list. The top 10 priorities in the domain of development were led by ideas on improved Kangaroo Mother Care at community level, how to improve the accuracy of diagnosis by community health workers, and perinatal audits. The 10 leading priorities for discovery research focused on stable surfactant with novel modes of administration for preterm babies, ability to diagnose fetal distress and novel tocolytic agents to delay or stop preterm labour.These findings will assist both donors and researchers in supporting and conducting research to close the knowledge gaps for reducing neonatal mortality, morbidity and long term impairment. WHO, SNL and other partners will work to generate interest among key national stakeholders, governments, NGOs, and research institutes in these priorities, while encouraging research funders to support them. We will track research funding, relevant requests for proposals and trial registers to monitor if the priorities identified by this exercise are being addressed.

Background\ud Verbal autopsy (VA), the process of interviewing a deceased’s family or caregiver about signs and symptoms leading up to death, employs tools that ask a series of closed questions and can include an open narrative where respondents give an unprompted account of events preceding death. The extent to which an individual interviewer, who generally does not interpret the data, affects the quality of this data, and therefore the assigned cause of death, is poorly documented. We aimed to examine inter-interviewer reliability of open narrative and closed question data gathered during VA interviews.\ud \ud Methods\ud During the introduction of VA data collection, as part of a larger study in Mchinji district, Malawi, we conducted partner interviews whereby two interviewers independently recorded open narrative and closed questions during the same interview. Closed questions were collected using a smartphone application (mobile-InterVA) and open narratives using pen and paper. We used mixed methods of analysis to evaluate the differences between recorded responses to open narratives and closed questions, causes of death assigned, and additional information gathered by open narrative.\ud \ud Results\ud Eighteen partner interviews were conducted, with complete data for 11 pairs. Comparing closed questions between interviewers, the median number of differences was 1 (IQR: 0.5–3.5) of an average 65 answered; mean inter-interviewer concordance was 92 % (IQR: 92–99 %). Discrepancies in open narratives were summarized in five categories: demographics, history and care-seeking, diagnoses and symptoms, treatment and cultural. Most discrepancies were seen in the reporting of diagnoses and symptoms (e.g., malaria diagnosis); only one pair demonstrated no clear differences. The average number of clinical symptoms reported was 9 in open narratives and 20 in the closed questions. Open narratives contained additional information on health seeking and social issues surrounding deaths, which closed questions did not gather.\ud \ud Conclusions\ud The information gleaned during open narratives was subject to inter-interviewer variability and contained a limited number of symptom indicators, suggesting that their use for assigning cause of death is questionable. However, they contained rich information on care-seeking, healthcare provision and social factors in the lead-up to death, which may be a valuable source of information for promoting accountable health services.

Background In 2013, an estimated 2.8 million newborns died and 2.7 million were stillborn. A much greater number suffer from long term impairment associated with preterm birth, intrauterine growth restriction, congenital anomalies, and perinatal or infectious causes. With the approaching deadline for the achievement of the Millennium Development Goals (MDGs) in 2015, there was a need to set the new research priorities on newborns and stillbirth with a focus not only on survival but also on health, growth and development. We therefore carried out a systematic exercise to set newborn health research priorities for 2013–2025. Methods We used adapted Child Health and Nutrition Research Initiative (CHNRI) methods for this prioritization exercise. We identified and approached the 200 most productive researchers and 400 program experts, and 132 of them submitted research questions online. These were collated into a set of 205 research questions, sent for scoring to the 600 identified experts, and were assessed and scored by 91 experts. Results Nine out of top ten identified priorities were in the domain of research on improving delivery of known interventions, with simplified neonatal resuscitation program and clinical algorithms and improved skills of community health workers leading the list. The top 10 priorities in the domain of development were led by ideas on improved Kangaroo Mother Care at community level, how to improve the accuracy of diagnosis by community health workers, and perinatal audits. The 10 leading priorities for discovery research focused on stable surfactant with novel modes of administration for preterm babies, ability to diagnose fetal distress and novel tocolytic agents to delay or stop preterm labour. Conclusion These findings will assist both donors and researchers in supporting and conducting research to close the knowledge gaps for reducing neonatal mortality, morbidity and long term impairment. WHO, SNL and other partners will work to generate interest among key national stakeholders, governments, NGOs, and research institutes in these priorities, while encouraging research funders to support them. We will track research funding, relevant requests for proposals and trial registers to monitor if the priorities identified by this exercise are being addressed.

The exposure of children to air pollution in low resource settings is believed to be high because of the common use of biomass fuels for cooking. We used microenvironment sampling to estimate the respirable fraction of air pollution (particles with median diameter less than 4 μm) to which 7–9 year old children in southern Nepal were exposed. Sampling was conducted for a total 2649 h in 55 households, 8 schools and 8 outdoor locations of rural Dhanusha. We conducted gravimetric and photometric sampling in a subsample of the children in our study in the locations in which they usually resided (bedroom/living room, kitchen, veranda, in school and outdoors), repeated three times over one year. Using time activity information, a 24-hour time weighted average was modeled for all the children in the study. Approximately two-thirds of homes used biomass fuels, with the remainder mostly using gas. The exposure of children to air pollution was very high. The 24-hour time weighted average over the whole year was 168 μg/m3. The non-kitchen related samples tended to show approximately double the concentration in winter than spring/autumn, and four times that of the monsoon season. There was no difference between the exposure of boys and girls. Air pollution in rural households was much higher than the World Health Organization and the National Ambient Air Quality Standards for Nepal recommendations for particulate exposure., Highlights • Air pollution exposure (respirable PM) was estimated for children in Nepal. • Gravimetric and photometric microenvironment sampling was conducted. • Total sampling was repeated three times over a year and totaled over 2500 hours. • The 24-hour time weighted average was 168 µg/m3. • There was substantial variability from season to season and by fuel type. • There was no difference in exposure between boys and girls.

The aim of this report is to describe a health education intervention involving volunteer infant feeding and care counselors being implemented in Mchinji district, Malawi.The intervention was established in January 2004 and involves 72 volunteer infant feeding and care counselors, supervised by 24 government Health Surveillance Assistants, covering 355 villages in Mchinji district. It aims to change the knowledge, attitudes and behaviour of women to promote exclusive breastfeeding and other infant care practices. The main target population are women of child bearing age who are visited at five key points during pregnancy and after birth. Where possible, their partners are also involved. The visits cover exclusive breastfeeding and other important neonatal and infant care practices. Volunteers are provided with an intervention manual and picture book. Resource inputs are low and include training allowances and equipment for counselors and supervisors, and a salary, equipment and materials for a coordinator.It is hypothesized that the counselors will encourage informational and attitudinal change to enhance motivation and risk reduction skills and self-efficacy to promote exclusive breastfeeding and other infant care practices and reduce infant mortality. The impact is being evaluated through a cluster randomised controlled trial and results will be reported in 2012.

Background: Delays in receiving effective care during labor and at birth may be fatal for the mother and fetus, contributing to 2 million annual intrapartum stillbirths and intrapartum-related neonatal deaths each year. Objective: We present a systematic review of strategies to link families and facilities, including community mobilization, financial incentives, emergency referral and transport systems, prenatal risk screening, and maternity waiting homes. Results: There is moderate quality evidence that community mobilization with high levels of community engagement can increase institutional births and significantly reduce perinatal and early neonatal mortality. Meta-analysis showed a doubling of skilled birth attendance and a 36% reduction in early neonatal mortality. However, no data are available on intrapartum-specific outcomes. Evidence is limited, but promising, that financial incentive schemes and community referral/transport systems may increase rates of skilled birth attendance and emergency obstetric care utilization; however, impact on mortality is unknown. Current evidence for maternity waiting homes and risk screening is low quality. Conclusions: Empowering communities is an important strategy to reduce the large burden of intrapartum complications. Innovations are needed to bring the poor closer to obstetric care, such as financial incentives and cell phone technology. New questions need to be asked of "old" strategies such as risk screening and maternity waiting homes. The effect of all of these strategies on maternal and perinatal mortality, particularly intrapartum-related outcomes, requires further evaluation. (C) 2009 Published by Elsevier Ireland Ltd. on behalf of International Federation of Gynecology and Obstetrics.