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Additional file 5: Supplementary Table 4. Multivariable logistic regression analysis of factors associated with timely initiation of breastfeeding (recall of the first days of life) among children aged 0–12 months. Supplementary Table 5. Multivariable logistic regression analysis of factors associated with colostrum feeding (recall of the first days of life) among children aged 0–12 months. Supplementary Table 6. Multivariable logistic regression analysis of factors associated with no pre-lacteal feeding (recall of the first days of life) among children aged 0–12 months. Supplementary Table 7. Multivariable logistic regression analysis of factors associated with exclusive breastfeeding in past 24 hours before survey among children aged 0–5 months. Supplementary Table 8. Multivariable logistic regression analysis of factors associated with timing of the introduction of solid, semi-solid or soft foods among children aged 7–59 months. Supplementary Table 9. Multivariable logistic regression analysis of factors associated with minimum dietary diversity among children aged 7–59 months. Supplementary Table 10. Multivariable logistic regression analysis of factors associated with consumption of animal foods among children aged 7–59 months. Supplementary Table 11. Multivariable logistic regression analysis of factors associated with consumption of fruits and vegetables among children aged 7–59 months.

Additional file 2: Supplementary Table 1. A summary of indicators available from each of 6-week questionnaire and the follow-up survey sample.

Additional file 1.

Additional file 3: Supplementary Table 2. The timing of the data collection for each of the IYCF indicators and the age range.

Additional file 4: Supplementary Table 3. Definition and categorisation of potential explanatory variables used in the study.

Additional file 1: Supplementary Figure 1. Flow chart of study participants. Supplementary Figure 2. Multivariable modelling procedure. Supplementary Figure 3. Complementary feeding practices in the past 24-hours by age when children were 7 to 59 months. Supplementary Figure 4. Percentage of children aged 7 to 59 months who experienced types of learning activities with different caregivers *other adults refers to maternal and paternal grandparents. Supplementary Figure 5. Early childhood index score by gender and wealth index when children were 36 -59 months.

Additional file 5: Supplementary Table 4. Socio-demographic characteristics of the FGD participants (ASHAs).

Additional file 3: Supplementary Table 2. Final coding structure for qualitative analysis.

Additional file 4: Supplementary Table 3. Socio-demographic characteristics of the FGD participants (women who had recently given birth).

Additional file 2: Supplementary Table 1. Focus group discussion tools with women who recently gave birth and ASHAs.

Additional file 1: Supplementary Figure 1. Intended programme pathway from ASHA home visits to perinatal health outcomes.

Additional file 1. Intervention theory of change.

Additional file 1: Table S1. Comparison of the characteristics of women who participated in both baseline and endline surveys.

Additional file 3. Trial outcomes and detailed questionnaire items.

Additional file 4. SPIRIT 2013 checklist.

Background Maternal and child undernutrition have adverse consequences for pregnancy outcomes and child morbidity and mortality, and they are associated with low educational attainment, economic productivity as an adult, and human wellbeing. ‘Nutrition-sensitive’ agriculture programs could tackle the underlying causes of undernutrition. Methods/design This study is a four-arm cluster randomised controlled trial in Odisha, India. Interventions are as follows: (1) an agricultural extension platform of women’s groups viewing and discussing videos on nutrition-sensitive agriculture (NSA) practices, and follow-up visits to women at home to encourage the adoption of new practices shown in the videos; (2) women’s groups viewing and discussing videos on NSA and nutrition-specific practices, with follow-up visits; and (3) women’s groups viewing and discussing videos on NSA and nutrition-specific practices combined with a cycle of Participatory Learning and Action meetings, with follow-up visits. All arms, including the control, receive basic nutrition training from government community frontline workers. Primary outcomes, assessed at baseline and 32 months after the start of the interventions, are (1) percentage of children aged 6–23 months consuming ≥ 4 out of 7 food groups per day and (2) mean body mass index (BMI) (kg/m2) of non-pregnant, non-postpartum (gave birth > 42 days ago) mothers or female primary caregivers of children aged 0–23 months. Secondary outcomes are percentage of mothers consuming ≥ 5 out of 10 food groups per day and percentage of children’s weight-for-height z-score 70%) proportion of Scheduled Tribe or Scheduled Caste (disadvantaged) households. A process evaluation will assess the quality of implementation and mechanisms behind the intervention effects. A cost-consequence analysis will compare incremental costs and outcomes of the interventions. Discussion This trial will contribute evidence on the impacts of NSA extension through participatory, low-cost, video-based approaches on maternal and child nutrition and on whether integration with nutrition-specific goals and enhanced participatory approaches can increase these impacts. Trial registration ISRCTN , ISRCTN65922679. Registered on 21 December 2016. Electronic supplementary material The online version of this article (10.1186/s13063-018-2521-y) contains supplementary material, which is available to authorized users.

Action Against Malnutrition Survey. (PDF 308 kb)

Effects of interventions on children’s weight-for-height, weight-for-age and height-for-age z scores. (PDF 34 kb)

Sample list of video and meeting topics for 7 fortnights of implementation. (PDF 62 kb)

Standard Protocol Items: Recommendations for Interventional Trials checklist. (DOC 121 kb)

Background: In the Peruvian Amazon, historical events of colonization and political marginalization intersect with identities of ethnicity, class and geography in the construction of gender and health inequities. Gender-based inequalities can manifest in poor health outcomes via discriminatory practices, healthcare system imbalances, inequities in health research, and differential exposures and vulnerabilities to diseases. Structural violence is a comprehensive framework to explain the mechanisms by which social forces such as poverty, racism and gender inequity become embodied as individual experiences and health outcomes, and thus may be a useful tool in structuring an intersectional analysis of gender and health inequities in Amazonian Peru. Objective: The aim of this paper is to explore the intersection of gender inequities with other social inequalities in the production of health and disease in Peru’s Amazon using a structural violence approach. Design: Exploratory qualitative research was performed in two Loreto settings – urban Iquitos and the rural Lower Napo River region – between March and November 2015. This included participant observation with prolonged stays in the community, 46 semi-structured individual interviews and three group discussions. Thematic analysis was performed to identify emerging themes related to gender inequalities in health and healthcare and how these intersect with layered social disadvantages in the reproduction of health and illness. We employed a structural violence approach to construct an intersectional analysis of gender and health inequities in Amazonian Peru. Results: Our findings were arranged into five interrelated domains within a gender, structural violence and health model: gender as a symbolic institution, systemic gender-based violence, interpersonal violence, the social determinants of health, and other health outcomes. Each domain represents one aspect of the complex associations between gender, gender inequity and health. Through this model, we were able to explore: gender, health and intersectionality; structural violence; and to highlight particular local gender and health dynamics. Intersecting influences of poverty, ethnicity, geography and gender served as significant barriers to healthcare in both rural and urban settings.

Population Health and Environment (PHE) strategies are argued to improve ecosystem and human health by addressing family size and its effects on natural resource use, food security, and reproductive health. This study investigates men's views on a PHE family planning (FP) programme delivered among the pastoral Samburu tribe in rural northern Kenya. Three focus group discussions and nine semi-structured interviews were conducted with 27 Samburu men. These discussions revealed support for environmentally-sensitised family planning promotion. Men highlighted their dependency on natural resources and challenges faced in providing for large families and maintaining livestock during drought. These practices were said to lead to natural resource exhaustion, environmental degradation, and wildlife dispersal, undermining key economic benefits of environmental and wildlife conservation. Relating family size to the environment is a compelling strategy to improve support for FP among Samburu men. Kenyan policy-makers should consider integrating community-based PHE strategies among underserved pastoral groups living in fragile ecosystems.

Summary Background Around 30% of the world's stunted children live in India. The Government of India has proposed a new cadre of community-based workers to improve nutrition in 200 districts. We aimed to find out the effect of such a worker carrying out home visits and participatory group meetings on children's linear growth. Methods We did a cluster-randomised controlled trial in two adjoining districts of Jharkhand and Odisha, India. 120 clusters (around 1000 people each) were randomly allocated to intervention or control using a lottery. Randomisation took place in July, 2013, and was stratified by district and number of hamlets per cluster (0, 1–2, or ≥3), resulting in six strata. In each intervention cluster, a worker carried out one home visit in the third trimester of pregnancy, monthly visits to children younger than 2 years to support feeding, hygiene, care, and stimulation, as well as monthly women's group meetings to promote individual and community action for nutrition. Participants were pregnant women identified and recruited in the study clusters and their children. We excluded stillbirths and neonatal deaths, infants whose mothers died, those with congenital abnormalities, multiple births, and mother and infant pairs who migrated out of the study area permanently during the trial period. Data collectors visited each woman in pregnancy, within 72 h of her baby's birth, and at 3, 6, 9, 12, and 18 months after birth. The primary outcome was children's length-for-age Z score at 18 months of age. Analyses were by intention to treat. Due to the nature of the intervention, participants and the intervention team were not masked to allocation. Data collectors and the data manager were masked to allocation. The trial is registered as ISCRTN (51505201) and with the Clinical Trials Registry of India (number 2014/06/004664). Results Between Oct 1, 2013, and Dec 31, 2015, we recruited 5781 pregnant women. 3001 infants were born to pregnant women recruited between Oct 1, 2013, and Feb 10, 2015, and were therefore eligible for follow-up (1460 assigned to intervention; 1541 assigned to control). Three groups of children could not be included in the final analysis: 147 migrated out of the study area (67 in intervention clusters; 80 in control clusters), 77 died after the neonatal period and before 18 months (31 in intervention clusters; 46 in control clusters), and seven had implausible length-for-age Z scores (

INTRODUCTION: Undernutrition affects ∼165 million children globally and contributes up to 45% of all child deaths. India has the highest proportion of global undernutrition-related morbidity and mortality. This protocol describes the planned economic evaluation of a community-based intervention to improve growth in children under 2 years of age in two rural districts of eastern India. The intervention is being evaluated through a cluster-randomised controlled trial (cRCT, the CARING trial). METHODS AND ANALYSIS: A cost-effectiveness and cost-utility analysis nested within a cRCT will be conducted from a societal perspective, measuring programme, provider, household and societal costs. Programme costs will be collected prospectively from project accounts using a standardised tool. These will be supplemented with time sheets and key informant interviews to inform the allocation of joint costs. Direct and indirect costs incurred by providers will be collected using key informant interviews and time use surveys. Direct and indirect household costs will be collected prospectively, using time use and consumption surveys. Incremental cost-effectiveness ratios (ICERs) will be calculated for the primary outcome measure, that is, cases of stunting prevented, and other outcomes such as cases of wasting prevented, cases of infant mortality averted, life years saved and disability-adjusted life years (DALYs) averted. Sensitivity analyses will be conducted to assess the robustness of results. ETHICS AND DISSEMINATION: There is a shortage of robust evidence regarding the cost-effectiveness of strategies to improve early child growth. As this economic evaluation is nested within a large scale, cRCT, it will contribute to understanding the fiscal space for investment in early child growth, and the relative (in)efficiency of prioritising resources to this intervention over others to prevent stunting in this and other comparable contexts. The protocol has all necessary ethical approvals and the findings will be disseminated within academia and the wider policy sphere. TRIAL REGISTRATION NUMBER: ISRCTN51505201; pre-results.

BACKGROUND: In a stepped wedge, cluster randomised trial, clusters receive the intervention at different time points, and the order in which they received it is randomised. Previous systematic reviews of stepped wedge trials have documented a steady rise in their use between 1987 and 2010, which was attributed to the design's perceived logistical and analytical advantages. However, the interventions included in these systematic reviews were often poorly reported and did not adequately describe the analysis and/or methodology used. Since 2010, a number of additional stepped wedge trials have been published. This article aims to update previous systematic reviews, and consider what interventions were tested and the rationale given for using a stepped wedge design. METHODS: We searched PubMed, PsychINFO, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Web of Science, the Cochrane Library and the Current Controlled Trials Register for articles published between January 2010 and May 2014. We considered stepped wedge randomised controlled trials in all fields of research. We independently extracted data from retrieved articles and reviewed them. Interventions were then coded using the functions specified by the Behaviour Change Wheel, and for behaviour change techniques using a validated taxonomy. RESULTS: Our review identified 37 stepped wedge trials, reported in 10 articles presenting trial results, one conference abstract, 21 protocol or study design articles and five trial registrations. These were mostly conducted in developed countries (n = 30), and within healthcare organisations (n = 28). A total of 33 of the interventions were educationally based, with the most commonly used behaviour change techniques being 'instruction on how to perform a behaviour' (n = 32) and 'persuasive source' (n = 25). Authors gave a wide range of reasons for the use of the stepped wedge trial design, including ethical considerations, logistical, financial and methodological. The adequacy of reporting varied across studies: many did not provide sufficient detail regarding the methodology or calculation of the required sample size. CONCLUSIONS: The popularity of stepped wedge trials has increased since 2010, predominantly in high-income countries. However, there is a need for further guidance on their reporting and analysis.

Background\ud\udThree arguments are usually invoked in favour of stepped wedge cluster randomised controlled trials: the logistic convenience of implementing an intervention in phases, the ethical benefit of providing the intervention to all clusters, and the potential to enhance the social acceptability of cluster randomised controlled trials. Are these alleged benefits real? We explored the logistic, ethical, and political dimensions of stepped wedge trials using case studies of six recent evaluations.\ud\udMethods\ud\udWe identified completed or ongoing stepped wedge evaluations using two systematic reviews. We then purposively selected six with a focus on public health in high, middle, and low-income settings. We interviewed their authors about the logistic, ethical, and social issues faced by their teams. Two authors reviewed interview transcripts, identified emerging issues through qualitative thematic analysis, reflected upon them in the context of the literature, and invited all participants to co-author the manuscript.\ud\udResults\ud\udOur analysis raises three main points. First, the phased implementation of interventions can alleviate problems linked to simultaneous roll-out, but also brings new challenges. Issues to consider include the feasibility of organising intervention activities according to a randomised sequence, estimating time lags in implementation and effects, and accommodating policy changes during the trial period. Second, stepped wedge trials, like parallel cluster trials, require equipoise: without it, randomising participants to a control condition, even for a short time, remains problematic. In stepped wedge trials, equipoise is likely to lie in the degree of effect, effectiveness in a specific operational milieu, and the balance of benefit and harm, including the social value of better evaluation. Third, the strongest arguments for a stepped wedge design are logistic and political rather than ethical. The design is advantageous when simultaneous roll-out is impractical and when it increases the acceptability of using counterfactuals.\ud\udConclusions\ud\udThe logistic convenience of phased implementation is context-dependent, and may be vitiated by the additional requirements of phasing. The potential for stepped wedge trials to enhance the social acceptability of cluster randomised trials is real, but their ethical legitimacy still rests on demonstrating equipoise and its configuration for each research question and setting.

Data extraction form. (DOCX 22 kb)

Further characteristics of studies that adopted a stepped wedge randomised controlled trial design included in the review. (DOCX 34 kb)

Background Perinatal common mental disorders (PCMDs) are a major cause of disability among women and disproportionately affect lower income countries. Interventions to address PCMDs are urgently needed in these settings, and group-based and peer-led approaches are potential strategies to increase access to mental health interventions. Participatory women’s health groups led by local women previously reduced postpartum psychological distress in eastern India. We assessed the effect of a similar intervention on postpartum psychological distress in rural Bangladesh.MethodWe conducted a secondary analysis of data from a cluster-randomised controlled trial with 18 clusters and an estimated population of 532,996. Nine clusters received an intervention comprising monthly meetings during which women’s groups worked through a participatory learning and action cycle to develop strategies for improving women’s and children’s health. There was one group for every 309 individuals in the population, 810 groups in total. Mothers in nine control clusters had access to usual perinatal care. Postpartum psychological distress was measured with the 20-item Self Reporting Questionnaire (SRQ-20) between six and 52 weeks after delivery, during the months of January to April, in 2010 and 2011.ResultsWe analysed outcomes for 6275 mothers. Although the cluster mean SRQ-20 score was lower in the intervention arm (mean 5.2, standard deviation 1.8) compared to control (5.3, 1.2), the difference was not significant (β 1.44, 95% CI 0.28, 3.08).ConclusionsDespite promising results in India, participatory women’s groups focused on women’s and children’s health had no significant effect on postpartum psychological distress in rural Bangladesh.

Background: There is a large burden of psychological distress in low and middle-income countries, and culturally relevant interventions must be developed to address it. This requires an understanding of how distress is experienced. We conducted a qualitative grounded theory study to understand how mothers experience and manage distress in Dhanusha, a low-resource setting in rural Nepal. We also explored how distressed mothers interact with their families and the wider community.Methods: Participants were identified during a cluster-randomised controlled trial in which mothers were screened for psychological distress using the 12-item General Health Questionnaire (GHQ-12). We conducted 22 semi-structured interviews with distressed mothers (GHQ-12 score ≥5) and one with a traditional healer (dhami), as well as 12 focus group discussions with community members. Data were analysed using grounded theory methods and a model was developed to explain psychological distress in this setting.Results: We found that distress was termed tension by participants and mainly described in terms of physical symptoms. Key perceived causes of distress were poor health, lack of sons, and fertility problems. Tension developed in a context of limited autonomy for women and perceived duty towards the family. Distressed mothers discussed several strategies to alleviate tension, including seeking treatment for perceived physical health problems and tension from doctors or dhamis, having repeated pregnancies until a son was delivered, manipulating social circumstances in the household, and deciding to accept their fate. Their ability to implement these strategies depended on whether they were able to negotiate with their in-laws or husbands for resources.Conclusions: Vulnerability, as a consequence of gender and social disadvantage, manifests as psychological distress among mothers in Dhanusha. Screening tools incorporating physical symptoms of tension should be envisaged, along with interventions to address gender inequity, support marital relationships, and improve access to perinatal healthcare.

OBJECTIVES: To describe the prevalence and determinants of births by caesarean section in private and public health facilities in underserved communities in South Asia. DESIGN: Cross-sectional study. SETTING: 81 community-based geographical clusters in four locations in Bangladesh, India and Nepal (three rural, one urban). PARTICIPANTS: 45,327 births occurring in the study areas between 2005 and 2012. OUTCOME MEASURES: Proportion of caesarean section deliveries by location and type of facility; determinants of caesarean section delivery by location. RESULTS: Institutional delivery rates varied widely between settings, from 21% in rural India to 90% in urban India. The proportion of private and charitable facility births delivered by caesarean section was 73% in Bangladesh, 30% in rural Nepal, 18% in urban India and 5% in rural India. The odds of caesarean section were greater in private and charitable health facilities than in public facilities in three of four study locations, even when adjusted for pregnancy and delivery characteristics, maternal characteristics and year of delivery (Bangladesh: adjusted OR (AOR) 5.91, 95% CI 5.15 to 6.78; Nepal: AOR 2.37, 95% CI 1.62 to 3.44; urban India: AOR 1.22, 95% CI 1.09 to 1.38). We found that highly educated women were particularly likely to deliver by caesarean in private facilities in urban India (AOR 2.10; 95% CI 1.61 to 2.75) and also in rural Bangladesh (AOR 11.09, 95% CI 6.28 to 19.57). CONCLUSIONS: Our results lend support to the hypothesis that increased caesarean section rates in these South Asian countries may be driven in part by the private sector. They also suggest that preferences for caesarean delivery may be higher among highly educated women, and that individual-level and provider-level factors interact in driving caesarean rates higher. Rates of caesarean section in the private sector, and their maternal and neonatal health outcomes, require close monitoring.

BACKGROUND: Approximately 1.2 million stillbirths occur in the intrapartum period, and a further 717,000 annual neonatal deaths are caused by intrapartum events, most of which occur in resource poor settings. We aim to test the 'double-hit' hypothesis that maternal infection in the perinatal period predisposes to neurodevelopmental sequelae from an intrapartum asphyxia insult, increasing the likelihood of an early neonatal death compared with asphyxia alone. This is an observational study of singleton newborn infants with signs of intrapartum asphyxia that uses data from three previously conducted cluster randomized controlled trials taking place in rural Bangladesh and India. METHODS: From a population of 81,778 births in 54 community clusters in rural Bangladesh and India, we applied mixed effects logistic regression to data on 3890 singleton infants who had signs of intrapartum asphyxia, of whom 769 (20%) died in the early neonatal period. Poor infant condition at five minutes post-delivery was our proxy measure of intrapartum asphyxia. We had data for two markers of maternal infection: fever up to three days prior to labour, and prolonged rupture of membranes (PROM). Cause-specific verbal autopsy data were used to validate our findings using previously mentioned mixed effect logistic regression methods and the outcome of a neonatal death due to intrapartum asphyxia. RESULTS: Signs of maternal infection as indicated by PROM, combined with intrapartum asphyxia, increased the risk of an early neonatal death relative to intrapartum asphyxia alone (adjusted odds ratio (AOR) 1.28, 95% CI 1.03 - 1.59). Results from cause-specific verbal autopsy data verified our findings where there was a significantly increased odds of a early neonatal death due to intrapartum asphyxia in newborns exposed to both PROM and intrapartum asphyxia (AOR: 1.52, 95% CI 1.15 - 2.02). CONCLUSIONS: Our data support the double-hit hypothesis for signs of maternal infection as indicated by PROM. Interventions for pregnant women with signs of infection, to prevent early neonatal deaths and disability due to asphyxia, should be investigated further in resource-poor populations where the chances of maternal infection are high.

International audience

Background Provision of essential newborn care (ENC) can save many newborn lives in poor resource settings but coverage is far from universal and varies by country and place of delivery. Understanding gaps in current coverage and where coverage is good, in different contexts and places of delivery, could make a valuable contribution to the future design of interventions to reduce neonatal mortality. We sought to describe the coverage of essential newborn care practices for births in institutions, at home with a skilled birth attendant, and at home without a skilled birth attendant (SBA) in rural areas of Bangladesh, Nepal, and India. Methods We used data from the control arms of four cluster randomised controlled trials in Bangladesh, Eastern India and from Makwanpur and Dhanusha districts in Nepal, covering periods from 2001 to 2011. We used these data to identify essential newborn care practices as defined by the World Health Organization. Each birth was allocated to one of three delivery types: home birth without an SBA, home birth with an SBA, or institutional delivery. For each study, we calculated the observed proportion of births that received each care practice by delivery type with 95% confidence intervals, adjusted for clustering and, where appropriate, stratification. Results After exclusions, we analysed data for 8939 births from Eastern India, 27 553 births from Bangladesh, 6765 births from Makwanpur and 15 344 births from Dhanusha. Across all study areas, coverage of essential newborn care practices was highest in institutional deliveries, and lowest in home non-SBA deliveries. However, institutional deliveries did not provide universal coverage of the recommended practices, with relatively low coverage (20%-70%) across all study areas for immediate breastfeeding and thermal care. Institutions in Bangladesh had the highest coverage for almost all care practices except thermal care. Across all areas, fewer than 20% of home non-SBA deliveries used a clean delivery kit, the use of plastic gloves was very low and coverage of recommended thermal care was relatively poor. There were large differences between study areas in handwashing, immediate breastfeeding and delayed bathing. Conclusions There remains substantial scope for health facilities to improve thermal care for the newborn and to encourage immediate and exclusive breastfeeding. For unattended home deliveries, increased handwashing, use of clean delivery kits and basic thermal care offer great scope for improvement.

Background In a stepped wedge, cluster randomised trial, clusters receive the intervention at different time points, and the order in which they received it is randomised. Previous systematic reviews of stepped wedge trials have documented a steady rise in their use between 1987 and 2010, which was attributed to the design’s perceived logistical and analytical advantages. However, the interventions included in these systematic reviews were often poorly reported and did not adequately describe the analysis and/or methodology used. Since 2010, a number of additional stepped wedge trials have been published. This article aims to update previous systematic reviews, and consider what interventions were tested and the rationale given for using a stepped wedge design. Methods We searched PubMed, PsychINFO, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Web of Science, the Cochrane Library and the Current Controlled Trials Register for articles published between January 2010 and May 2014. We considered stepped wedge randomised controlled trials in all fields of research. We independently extracted data from retrieved articles and reviewed them. Interventions were then coded using the functions specified by the Behaviour Change Wheel, and for behaviour change techniques using a validated taxonomy. Results Our review identified 37 stepped wedge trials, reported in 10 articles presenting trial results, one conference abstract, 21 protocol or study design articles and five trial registrations. These were mostly conducted in developed countries (n = 30), and within healthcare organisations (n = 28). A total of 33 of the interventions were educationally based, with the most commonly used behaviour change techniques being ‘instruction on how to perform a behaviour’ (n = 32) and ‘persuasive source’ (n = 25). Authors gave a wide range of reasons for the use of the stepped wedge trial design, including ethical considerations, logistical, financial and methodological. The adequacy of reporting varied across studies: many did not provide sufficient detail regarding the methodology or calculation of the required sample size. Conclusions The popularity of stepped wedge trials has increased since 2010, predominantly in high-income countries. However, there is a need for further guidance on their reporting and analysis. Electronic supplementary material The online version of this article (doi:10.1186/s13063-015-0839-2) contains supplementary material, which is available to authorized users.