Bhandari 2012a.

Study characteristics
Methods	Design: cluster‐randomized controlled trial Unit of randomization: catchment areas of 18 primary health centres
Participants	Inclusion criteria: children up to 12 months of age in the catchment areas of the 18 primary health centres included in study Exclusion criteria: none reported
Interventions	Intervention Training lay health workers (existing cadre of ASHAs to provide iCCM for diarrhoea, malaria (in high‐risk areas), pneumonia (ARI) and malnutrition among children aged 0–59 months Recruiting and training other types of health workers (providers at public and private sector health facilities) to provide IMNCI Providing incentives for lay health workers for home visits (Anganwadi workers), women's group meetings (ASHAs) and sick child contacts (ASHAs) Providing iCCM providers with drugs and equipment Implementing simplified IMCI‐adapted clinical guidelines for iCCM providers (ASHAs) Implementing referral of children with severe disease to health facilities Training Anganwadi workers to conduct postnatal home visit Training ASHAs on conducting women's group meetings Implementing women's group meetings Implementing postnatal home visits by Anganwadi workers and convening women's groups by ASHAs based on the training above Training supervisors of lay health workers (Anganwadi workers and ASHAs) on effective supervision Providing supervision to lay health workers (Anganwadi workers and ASHAs); frequency, content and approach of supervision not reported Comparison Usual facility services
Outcomes	Mortality Neonatal mortality (deaths between birth and day 28 of life) and inequity gradient thereof Mortality beyond the first 24 hours of birth (deaths between day 2 and day 28 of life) Infant mortality (deaths between birth and day 365 of life) and inequity gradient thereof Perinatal mortality (stillbirths and deaths between birth and day 7 of life) Postneonatal mortality (deaths between day 29 and day 365 of life) and inequity gradient thereof Nutrition Wasting Stunting Coverage of health services Immunization coverage and inequity gradient thereof Healthy practices by caregiver Newborn care practices and inequity gradient thereof Care seeking behaviour and inequity gradient thereof Complementary feeding and inequity gradient thereof
Notes	Objective: to evaluate the Indian IMNCI programme, which integrates improved treatment of illness for children with home visits for newborn care, inform its scale‐up. Location: catchment areas of 18 primary health centres in a mixed rural/urban environment within the district of Faridabad, Haryana, India with a population of 1.1 million (10,694–72,059 per primary health centre). Funding source: WHO Geneva through a grant from USAID; UNICEF, New Delhi; GLOBVAC Program of the Research Council of Norway through grant No. 183722. The authors reported that WHO and UNICEF staff contributed importantly to the planning, analysis and reporting of the study but the funding bodies had no influence on how the data were collected, analyzed or presented.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "We divided the clusters into three strata containing six clusters each according to their baseline neonatal mortality rate. An independent epidemiologist generated 10 stratified randomisation schemes to allocate the clusters to intervention or control groups. We excluded three of these schemes, which had large differences in neonatal mortality rate, proportion of home births, proportion of mothers who had never been to school, and population size. We selected one of the remaining seven allocation schemes by a computer generated random number." P. 2.
Allocation concealment (selection bias)	Low risk	An independent epidemiologist generated 10 stratified randomization schemes to allocate the clusters to intervention or control groups.
Blinding of participants and personnel (performance bias) All outcomes	High risk	No blinding of participants and personnel. Lay health workers would have known if they received additional training and this may have biased their performance. Allocation was by village and parents may have known that the health workers at their primary health centre had received additional training and this may have biased their care seeking behaviour or responses to questionnaires, or both.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Surveillance teams, research assistants and independent teams conducted data collection per the description below from the study. The study indicated the surveillance teams were blinded. Unclear whether the research assistants or independent teams were blinded. Quote: "Data were collected by a team of 110 study field workers who were not involved with IMNCI implementation. The workers visited the allocated households every month to identify new pregnancies and inquire about the outcome of previously identified pregnancies. All households with live births were visited on day 29 and at ages 3, 6, 9, and 12 months to document the vital status of the infant. The surveillance team comprised workers who resided in or near to the areas allocated to them. The surveillance team was not told the intervention status of the community they were visiting. The follow‐up procedures were identical in all the clusters. A separate team of research assistants interviewed a randomly selected sub‐sample of mothers at 29 days to ascertain newborn care practices and exposure to the intervention. An independent team visited each household with a death as soon as possible to do a verbal autopsy, a technique for ascertaining the probable cause of death used in settings lacking vital registration and medical certification of deaths." P. 3. Despite the above measures, the residual risk of detection bias was unclear. The research assistants and independent teams may not have been blinded. Since the surveillance teams were selected from or near the areas allocated to them, they may have ascertained which arm they were working in through their daily interactions with the population. Similarly, even if blinded, the research assistants and independent teams may have ascertained which arm they were in from interactions with participants.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Quote: "almost all recruited live born infants were followed for the newborn period (97.8%), only 75.4% were followed for six months and 52.6% until the end of infancy". P. 4. Comment: 15,899/29,782 in intervention clusters and 16,055/30,920 had known vital status at 12 months.
Selective reporting (reporting bias)	Low risk	No evidence of selective reporting.
Baseline outcomes similar	Low risk	Baseline outcomes were similar.
Baseline characteristics similar	Unclear risk	There were some differences in baseline characteristics. Quote: "Intervention areas were less accessible, had a lower proportion of births in health facilities, and had families with lower economic status but higher literacy." Comment: these differences would have favoured control areas. The authors reported controlling for these differences in analysis.
Contamination	Low risk	The 18 clusters were contiguous; however, the risk of contamination was likely low, owing to the large size of clusters and the way health service delivery was organized.
Other bias	Low risk	No other apparent source of bias was detected.