Discussion
This study demonstrates the sustained implementation and clinical effectiveness of home-based management of neonatal sepsis over a 23-year period in rural Gadchiroli, India. Specially, CHWs correctly diagnosed 89.3% of sepsis cases (figure 2) and there was persistent parental adoption (>78%) of home-based antibiotic therapy (figure 3). Moreover, neonates treated at home had a significantly lower adjusted odds of death compared with all other treatment types (figure 4 and online supplemental appendix D) with no reported injection complications. However, the reduced coverage in the last two time epochs and the declining incidence of sepsis highlight the decreasing need for home-based management of sepsis as the rate of health facility births and access to hospitalisation have increased over time (figure 1).
At its foundation, sustainability is the ongoing implementation of an intervention beyond its trial period with continuation of the desired outcomes while allowing for some degree of adaptation.16 Multiple elements of SEARCH’s home-based management of neonatal sepsis might have contributed to its sustainability. First, SEARCH has maintained local acceptance since its inception through ongoing efforts to secure community involvement and buy-in. Second, the choice of using women who reside within the community and are available everyday as CHWs was a crucial factor in achieving the high coverage rate. The overall high coverage rate and quality of care provided by the CHW were maintained through a motivated and skilled human resource with refresher training, regular field supervision and performance-based remuneration. Finally, SEARCH’s HBNC programme has benefited from long-term funding granted by national and international philanthropic sources, including the MacArthur Foundation, the Bill and Melinda Gates Foundation and the Tata Trusts.
As the pioneer of home-based management of neonatal sepsis,4 SEARCH has the unique advantage of the longest continuous experience and data on procedures and outcomes. To our knowledge, this is the first report of long-term sustainability of home-based management of neonatal sepsis. Since the 2015 release of WHO’s guidelines for community-based management of sepsis in young infants,11 there has been preliminary implementation research in sub-Saharan and South Asian countries to assess local feasibility and adoption.17–26 Similar to our findings, most sites found that the vast majority of families refused referral to a health facility but agreed to outpatient antibiotic therapy.17 20 21 26 The ability of primary healthcare workers to correctly identify sepsis and adhere to management protocols varied greatly by site,17–26 opening the opportunity for collaboration and education between sites as well as the need for ongoing local adaptation. Of note, families at the majority of sites in other studies needed to bring their child to a primary health centre daily to be assessed and receive injections as opposed to SEARCH’s programme in Gadchiroli in which all management was provided at home. In addition, the WHO diagnostic criteria and antibiotic regimen differ slightly from those used by SEARCH, which were developed based on analysis of local efficacy prior to publication of the WHO guidelines.5 11
Interestingly, compared with neonates who received home-based treatment, the adjusted odds of mortality was more than 5 times higher for neonates whose parents accepted hospital referral (online supplemental appendix D). We believe that hospital referral was associated with higher risk of death for two reasons. First, neonates who were referred to a hospital had a more severe illness presentation, placing them at higher risk for mortality. Second, home-based treatment has the crucial advantage of ensuring prompt treatment with antibiotics after a diagnosis of sepsis is made. When neonates are referred to hospital, there is often a delay in accessing treatment and some may never receive antibiotics.
A concern that has been raised about community-based management of neonatal sepsis is the potential for indiscriminate usage of antibiotics leading to antimicrobial resistance.27 However, in the current study only 5.2% (929/17 700) of all births seen by CHWs received home-based antibiotics. This rate is not very dissimilar to the 3.1% of all infants <3 months of age in the USA who were hospitalised for sepsis treatment from 1988 to 2006.28 In the current study, only 22 neonates were incorrectly diagnosed and treated for sepsis (false positives), and all of these episodes occurred prior to the year 2000. In addition, there were no injection-related complication in the >10 000 injections that were administered. Finally, the fact that the mortality in treated neonates did not rise over the 23-year study period indirectly suggests that antimicrobial resistance is not an emerging problem in our population. Together, these results confirm that rational usage of oral and injectable antibiotics by CHWs is possible with a strict diagnostic definition and high-quality training and supervision.
Following the local sustainability of a health intervention, the next question is whether the intervention can be scaled-up. Through several partnerships, SEARCH has replicated the comprehensive HBNC to other parts of India with successful reduction in neonatal mortality when the package was delivered by a dedicated health worker in the community.29 However, these health workers in the field trial only administered home-based antibiotic therapy to 40% of the infants with suspected sepsis compared with 88.4% in Gadchiroli, suggesting that additional effort is needed to improve compliance.29
The majority of India’s rural poor receive health services from the Government of India’s National Rural Health Mission (NRHM). The NRHM engages ASHAs who are female CHWs focused primarily on reproductive and child health. In 2011, the NRHM decided to incorporate HBNC and deliver it through ASHAs in rural India.30 Since then, SEARCH, the National Health Systems Resource Centre and state governments have trained nearly 900 000 ASHAs to provide HBNC, including screening, diagnosing and either referring neonates with sepsis or treating with oral co-trimoxazole or amoxicillin when referral is not possible.31 The ASHAs have been deployed in SEARCH’s 39 study villages as well, creating some overlap which may explain the reduction in the screening coverage by SEARCH’s CHWs in the later years (figure 1). The reduced coverage may also be explained by the discontinuity in care caused by the increase in health facility births during the later years.
During the 23-year study period, several other changes occurred in rural India. Since 2006, the national policy increasingly favoured facility-based deliveries. A national scheme called Janani Suraksha Yojana was launched by government which offered cash incentive to mothers as well as ASHAs for facility-based delivery. This resulted in a rapid shift towards institutional delivery as seen in our data as well (figure 1). Moreover, the socioeconomic standard and women’s education improved, maternal and neonatal care practices changed to align with best practices. Most probably due to these changes, coupled with the continued HBNC by SEARCH’s CHWs and ASHAs, the incidence of neonatal sepsis in these 39 villages progressively declined. We have previously reported that the incidence of sepsis declined from 111 per 1000 live births (1998–2001) to 19 per 1000 live births (2016–2019).32 Presummably, facility-based delivery also led to increased identification and treatment of early onset sepsis in the facility. This also might have contributed to the decreasing number of cases of sepsis treated during the study period (table 1).
It is a welcome trend that over the past two decades the need for home-based management of sepsis has substantially reduced, and hopefully, at some time in the future, home-based management of sepsis will no longer be required. Until such time, home-based management should continue to fill the gap for families for whom facility-based care is inaccessible, unaffordable or unacceptable, including those who give birth at a health facility but require community-based follow-up.
A few limitations of our study should be explored. First, the diagnosis of sepsis was based solely on clinical signs without microbiological confirmation. Because clinical signs of neonatal sepsis are non-specific, we might have overestimated the true incidence of bacterial infections. This is an unavoidable limitation in resource-limited settings. In addition, the reduced mortality in treated versus untreated neonates suggests that the benefits of not missing a case of sepsis outweigh the risk of overtreatment. Moreover, even in resource-rich hospitals, the current standard of practice dictates the initiation of antibiotics when there is any clinical suspicion of neonatal sepsis. Second, the diagnosis of sepsis in this study relied on the recording of clinical criteria by CHWs who have significantly less training than physicians or nurses. Nevertheless, a previous study in Gadchiroli demonstrated a 92% concordance between data on neonates recorded by CHWs compared with a visiting physician.33 Finally, our cohort of untreated neonates with sepsis was a non-random, heterogeneous compilation (ie, neonates whose families refused all treatment and neonates whose sepsis diagnoses were missed by the CHW but determined by the computer algorithm), which may have introduced selection bias. The direction of bias is unknown as parents who refused treatment could have assessed their child’s illness as either mild with no need for treatment or hopeless with no expected benefit from treatment. This limitation was not preventable given that it would have been unethical to randomise neonates with sepsis not to receive any treatment. While our comparison between treated and untreated is opportunistic, the protective effect of treatment was apparent even after adjusting for confounders.
