Home-based management of neonatal sepsis: 23 years of sustained implementation and effectiveness in rural Gadchiroli, India, 1996-2019.

INTRODUCTION: Although hospitalisation remains the preferred management for neonatal sepsis, it is often not possible in resource-limited settings. The Home-Based Newborn Care (HBNC) study in Gadchiroli, India (1995-1998) was the first trial to demonstrate that neonatal sepsis can be managed in the community. HBNC continues to operate in Gadchiroli. In 2015, WHO recommended community-based management of neonatal sepsis when hospitalisation is not feasible but called for implementation research. We studied the implementation and effectiveness of home-based management of neonatal sepsis over 23 years in Gadchiroli. METHODS: In this cohort study (1996-2019), community health workers (CHWs) visited neonates at home in 39 villages in Gadchiroli, India. CHWs screened, diagnosed sepsis and offered home-based antibiotic treatment if hospitalisation was refused. We evaluated the implementation outcomes of coverage, diagnostic fidelity and adoption. We assessed the association between treatment type and odds of neonatal death using mixed effects logistic regression. Time trends were analysed using the Mann-Kendall test. RESULTS: CHWs screened 93.8% (17 700/18 874) of neonates (coverage) and correctly diagnosed 89% (1051/1177) of sepsis episodes (diagnostic fidelity). Home-based management was preferred by 88.4% (929/1051) of parents (adoption), with 5.6 percent of total neonates receiving antibioties at home. Compared with neonates treated at home, the adjusted odds of death was 5.27 (95% CI 1.91 to 14.58) times higher when parents refused all treatment, 2.17 (95% CI 1.07 to 4.41) times higher when CHWs missed the diagnosis and 5.45 (95% CI 2.74 to 10.87) times higher when parents accepted hospital referral. Implementation outcomes remained consistent over 23 years (coverage p=0.57; fidelity p=0.57; adoption p=0.26; mortality p=0.71). The rate of facility births increased (p<0.01) and the sepsis incidence decreased (p<0.05) over 23 years. CONCLUSION: Implementation of home-based management of neonatal sepsis was sustainable and effective over 23 years. During this period, the need for home-based management in Gadchiroli is declining. Home-based management is advised where sepsis remains a major cause of neonatal mortality and hospital access is limited.

Epidemiology of pain in back and extremities in rural population: A community-based estimation of age- and sex-specific prevalence, distribution, duration and intensity of pain, number of painful sites and seasonality of pain during twelve months in rural Gadchiroli, India.

BACKGROUND: Population-based estimates of the burden of pain in back and extremities (PBE) by sex, age, intensity, seasonality and site are lacking from rural India. METHODS: Two villages were randomly selected from a cluster of 39 villages in Gadchiroli district in India. All residents'≥20 years of age were surveyed in January 2010 by trained surveyors by making household visits. Information on PBE in the 12 months prior to survey was obtained using a structured, pretested questionnaire. RESULTS: The 12-month period prevalence of PBE was 75% (95% confidence interval CI = 72.54-77.73) in men and 91% (95% CI = 88.66-92.13) in women. The prevalence of PBE in the participants >50 years was 94% while that in the age group 20 to 50 years was 79% (P < 0.05). The site with the highest prevalence of pain was low back (women 80%, men 59%). The mean number of painful sites per person was 5.42 (95% CI = 5.17-5.67) in women, 3.68 (95% CI = 3.45-3.90) in men, 3.89 (95% CI = 3.71-4.07) in participants aged 20 to 50 years and 6.48 (95% CI = 6.11-6.85) in those >50 years. Among participants across the age and sex groups, the prevalence of mild pain was higher than severe pain at all the anatomical sites. Among various seasons, the highest prevalence of pain was in the rainy season (14%). CONCLUSION: The prevalence and the number of painful sites were higher among women and in those >50 years of age. The public health interventions for PBE need to focus on these two high risk groups.

Burden of pain in back and extremities in rural population: A community-based estimation of 12-month prevalence, distribution and duration of pain in rural Gadchiroli, India.

BACKGROUND: Population based estimates of the burden of pain in back and extremities (PBE) are lacking from rural India. We estimated this burden, measured as a) 12-month prevalence, b) site specific prevalence c) total number of painful sites per adult, d) severity of pain and e) duration of pain in the rural adult population in Gadchiroli, India, over a period of 12 months. METHODS: This population-based, cross-sectional study was conducted in two villages randomly selected from a cluster of 7 eligible villages in Gadchiroli district of India. All adults ≥20 years in these villages were surveyed by the trained community health workers in January 2010 by making household visits. The data were collected using a structured, pretested questionnaire on the history of pain in back and extremities (PBE) at various anatomical sites and its features during the previous 12 months. RESULTS: Out of 2535 eligible adults in two villages, 2259 (89%) were interviewed, of which 1876 (83%) had an episode of PBE in the preceding 12 months. The period prevalence of pain was 76% in back (including lower back, thoracic and neck) and 71% in the extremities. Highest site specific prevalence was at lower back (70%), knee (46%), neck (44%), leg/calf (39%) and mid-back (39%). The mean number of painful sites per adult was 4.57 (standard deviation (SD) = 4.17). The prevalence of severe pain was 15%. The mean number of painful days due to PBE was 166 days. Female gender (odds ratio (OR) = 2.8, 95% confidence interval (CI) = 2.1-3.6), farming/labour occupation (OR = 1.8, 95% CI = 1.4-2.4), increasing age (more than 60 years OR = 6.3, 95% CI = 3.3-11.9) were significantly associated with the risk of PBE. CONCLUSION: Nearly five out of six adults in rural Gadchiroli suffered from pain in back or extremities during the preceding 12 months. Pain was at multiple sites and was present on a mean 166 days in the year. Female gender, farming / manual labor as occupation and increasing age were the key risk factors identified. The pain in back and extremities emerges as a public health priority in rural communities.

Activity limitation and disability due to pain in back and extremities in rural population: A community-based study during a period of twelve months in rural Gadchiroli, India.

BACKGROUND: Population based estimates of the extent of the activity limitation due to back pain and disability due to musculoskeletal pains are lacking from rural India. We estimated this burden as a) extent of activity limitation due to back pain, b) disability due to musculoskeletal pains, c) grading of the limitation of each activity due to back and musculoskeletal pain in the rural adult population in Gadchiroli, India. METHODS: This population-based, cross-sectional study was conducted in two villages randomly selected from a cluster of 7 eligible villages in Gadchiroli district of India. All adults ≥20 years in these villages were surveyed by the trained community health workers in January 2010. Disability due to back pain was evaluated using newly developed questionnaire for women and men which assessed limitations in the gender-specific daily household and occupational activities in a rural area. Disability due to pain in extremities was assessed using the Health Assessment Questionnaire (HAQ). RESULTS: The total population of the two villages was 3735 out of which 2535 (67.9%) were adults ≥20 years of age and were eligible to participate in the study. Of these, 2259 (89%) were interviewed and 1247 participants (55%) had any pain on the day of the survey. Activity limitation questionnaire was filled for 716 (91.4%) out of 783 patients with back pain. HAQ scale was filled for 524 (85.2%) out of 615 patients with pain in extremities. Among men with back pain, respectively 11%, 19%, 60% and 11% had no, mild, moderate to severe difficulty or were completely unable to perform agrarian work, while among women, respectively 6%, 20%, 69% and 4% had no, mild, moderate to severe difficulty or were completely unable to perform household activities. Based on the HAQ score, respectively 1%, 67%, 18% and 14% of the participants had no, mild, moderate to severe disability or were completely unable to perform the activities. CONCLUSIONS: This community-based study in rural Gadchiroli demonstrates significant mild to moderate disability and activity limitation, due to pain in back and extremities in a population involved in hard manual work, especially agricultural and underlines the need to address the problem through appropriate interventions. The study also employs for the first time an indigenously developed questionnaire to identify activity limitation due to back pain, and demonstrates the method as well as the questionnaire.

Clinical patterns and their prevalence among adult population with back pain: A community-based cross-sectional study in rural Gadchiroli, India.

BACKGROUND: Evaluating clinical patterns and their prevalence of back pain, a common problem in rural areas, can help develop treatment strategies to address this leading cause of disability. METHODS: We conducted a population-based study in rural Gadchiroli, India. In this, two-phase study, trained surveyors conducted a door to door survey (Phase 1) to identify individuals with pain in the back and extremities in two villages randomly selected using pre-defined criteria. Those with pain were evaluated by a team of spine surgeons and rheumatologists to diagnose clinical conditions among these patients (Phase 2). RESULTS: Of the 2535 eligible adults, 2259 (89%) were screened, 1247 (55%) reported pain in back and limb and were referred to the specialist clinic. Out of the 906 (73%) participants who attended the clinics, 783 (89%) had back/neck pain. The point prevalence of back/neck pain among adults was 49% (95% confidence interval (CI) = 49%-51%), non-specific low back pain 45% (95% CI = 43.4%-47.5%); non-specific neck pain 21% (95% CI = 18.9-22.4), radiculopathy 12 (95% CI = 10.4-13.1), myelopathy 0.4 (95% CI = 0.1-0.7) and other serious spinal disorders 0.2 (95% CI 0.048-0.45). The prevalence of non-specific back/neck pain and radiculopathy was higher among females. CONCLUSIONS: Non-specific back and neck pain are the commonest diagnoses among those with pain in the back and extremities, followed by radiculopathy. Serious disorders are rare. Given the high prevalence of non-specific back and neck pain, community health workers and physicians working in rural areas need to be trained systematically to manage these conditions.

Decline in the Incidence of Neonatal Sepsis in Rural Gadchiroli, India During the Twenty-one Years (1998-2019) Following the Home-based Neonatal Care Field-trial.

BACKGROUND: Sepsis is a leading cause of neonatal mortality globally. The home-based neonatal care (HBNC) field trial (1995-1998) in rural Gadchiroli demonstrated a reduction in the incidence of neonatal sepsis. The current study examines the trend of neonatal sepsis during the twenty-one years (1998-2019) following the trial's completion. METHODS: We conducted a retrospective cohort study based on the HBNC program data in rural Gadchiroli, India, from April 1998 to March 2019. All live-born neonates who spent all or part of the neonatal period in the 39 study villages and received HBNC were eligible for inclusion. Sepsis was diagnosed during regular home visits by trained village health workers if pre-specified clinical criteria were present. Sepsis incidence was computed for seven 3-year periods. Trend analyses were conducted using the Mann-Kendall test. RESULTS: Of the total 17,289 live births, 16,339 (94.5%) home visited were included. In this cohort, 1069 (65 per 1000 live births) neonates were diagnosed with sepsis. The incidence of neonatal sepsis declined from 111 per 1000 live births in 1998 to 2001 to 19 per 1000 live births in 2016 to 2019, an 82.9% decrease (P < 0.0001), mean 4% decrease per year. The incidence of neonatal sepsis declined for early-onset sepsis (P < 0.0001), late-onset sepsis (P < 0.0001), home births (P = 0.006), facility births (P < 0.0001), preterm neonates (P < 0.0001) and full-term neonates (P < 0.0001). CONCLUSIONS: The incidence of neonatal sepsis in rural Gadchiroli has continued to decline during the past twenty-one years. We hypothesize that the decline is due to the ongoing practice of HBNC, improved socioeconomic conditions, and new governmental health policies.

Control of scabies in a tribal community using mass screening and treatment with oral ivermectin -A cluster randomized controlled trial in Gadchiroli, India.

BACKGROUND: Scabies is often endemic in tribal communities and difficult to control. We assessed the efficacy of a community-based intervention using mass screening and treatment with oral ivermectin in controlling scabies. METHODS/ FINDINGS: In this cluster randomised controlled trial, 12 villages were randomly selected from a cluster of 42 tribal villages in Gadchiroli district. In these villages, trained community health workers (CHWs) conducted mass screening for scabies. The diagnosis was confirmed by a physician. Six villages each were randomly allocated to the intervention and usual care arm (control arm). In the intervention arm (population 1184) CHWs provided directly observed oral ivermectin to scabies cases and their household contacts. In the usual care arm (population 1567) scabies cases were referred to the nearest clinic for topical treatment as per the standard practice. The primary outcome was prevalence of scabies two months after the treatment. Secondary outcomes were prevalence of scabies after twelve months of treatment and prevalence of impetigo after two and twelve months of treatment. Outcomes were measured by the team in a similar way as the baseline. The trial was registered with the clinical trial registry of India, number CTRI/2017/01/007704. In the baseline, 2 months and 12 months assessments 92.4%, 96% and 94% of the eligible individuals were screened in intervention villages and 91.4%, 91.3% and 95% in the usual care villages. The prevalence of scabies in the intervention and usual care arm was 8.4% vs 8.1% at the baseline, 2.8% vs 8.8% at two months [adjusted relative risk (ARR) 0.21, 95% CI 0.11-0.38] and 7.3% vs 14.1% (ARR 0.49, 95% CI 0.25-0.98) at twelve months The prevalence of impetigo in the intervention and usual care arm was 1.7% vs 0.6% at baseline, 0.6% vs 1% at two months (ARR 0.55, 95% CI 0.22-1.37) and 0.3% vs 0.7% at 12 months (ARR 0.42, 95% CI 0.06-2.74). Adverse effects due to ivermectin occurred in 12.1% of patients and were mild. CONCLUSIONS: Mass screening and treatment in the community with oral ivermectin delivered by the CHWs is superior to mass screening followed by usual care involving referral to clinic for topical treatment in controlling scabies in this tribal community in Gadchiroli.

Gaps in secondary prevention among stroke survivors in rural Gadchiroli, India: a community-based cross-sectional study.

Background: With epidemiological transition, stroke has emerged as a public health priority in rural India. However, population-level information on secondary prevention of stroke from rural areas of India and other low- and middle-income countries remains exceedingly rare. Methods: In a cross-sectional community-based survey, trained surveyors screened a well-defined population of 74,095 individuals living in 64 villages in Gadchiroli district of India for symptoms of stroke. A trained physician evaluated screen positive patients, diagnosed stroke, measured blood pressure and collected information on prior diagnosis of risk factors and current use of medications using a structured questionnaire. Results: A total of 265 stroke survivors were identified. Prior diagnosis of hypertension was made in 57.4%, diabetes in 9.8%, hyperlipidaemia in 0.4%, ischaemic heart disease in 1.5%. and atrial fibrillation in 1.1%. Blood pressure was uncontrolled (>140/90) in 46% of stroke survivors. Among men 71.2% used tobacco and 30% used alcohol, while among women 38.2% used tobacco and none used alcohol. Only 40.8% of stroke survivors were receiving antihypertensive medications, while 10.6% were on antiplatelet agents and 4.9% were on statins. In a multivariate analysis, age <50 years (OR 0.2, 95% CI 0.1-0.5), male sex (OR 0.2, 95% CI 0.2-0.8) and lower economic status (no assets vs four assets; OR 0.3, 95% CI 0.1-0.9) were associated with lower odds of receiving medications for secondary prevention of stroke. Conclusions: There were significant gaps in secondary prevention of stroke in rural Gadchiroli. Healthcare programmes for secondary prevention of stroke in rural areas will have to ensure that blood pressure is adequately controlled, alcohol and tobacco cessation is promoted and special attention is paid to those who are younger, men and economically weaker.

Effect of home-based newborn care on neonatal and infant mortality: a cluster randomised trial in India.

BACKGROUND: Home-based newborn care has been found to reduce neonatal mortality in rural areas. Study evaluated effectiveness of home-based care delivered by specially recruited newborn care workers- Shishu Rakshak (SR) and existing workers- anganwadi workers (AWW) in reducing neonatal and infant mortality rates. METHODS: This three-arm, community-based, cluster randomised trial was conducted in five districts in India. Intervention package consisted of pregnancy surveillance, health education, care at birth, care of normal/low birthweight neonates, identification and treatment of sick neonates and young infants using oral and injectable antibiotics and community mobilisation. The package was similar in both intervention arms-SR and AWW; difference being healthcare provider. The control arm received routine health services from the existing health system. Primary outcomes were neonatal and young infant mortality rates at 'endline' period (2008-2009) assessed by an independent team from January to April 2010 in the study clusters. FINDINGS: A total of 6623, 6852 and 5898 births occurred in the SR, AWW and control arms, respectively, during the endline period; the proportion of facility births were 69.0%, 64.4% and 70.6% in the three arms. Baseline mortality rates were comparable in three arms. During the endline period, the risk of neonatal mortality was 25% lower in the SR arm (adjusted OR 0.75, 95% CI 0.57 to 0.99); the risks of early neonatal mortality, young infant mortality and infant mortality were also lower by 32%, 27%, and 33%, respectively. The risks of neonatal, early neonatal, young infant, infant mortality in the AWW arm were not different from that of the control arm. INTERPRETATION: Home-based care is effective in reducing neonatal and infant mortality rates, when delivered by a dedicated worker, even in settings with high rates of facility births. TRIAL REGISTRATION NUMBER: The study was registered with Clinical Trial Registry of India (CTRI/2011/12/002181).

Stroke Happens Suddenly so It Cannot Be Prevented: A Qualitative Study to Understand Knowledge, Attitudes, and Practices about Stroke in Rural Gadchiroli, Maharashtra, India.

Background Strokes have emerged as one of the leading causes of deaths in rural India but people often remain uninformed about it. This study sought to understand knowledge, attitudes, and healthcare-seeking practices about strokes in rural Gadchiroli, India. Methods A total of 12 focus group discussions were conducted with 34 female and 43 male participants from six villages. Responses were audio recorded, transcribed, coded, and analyzed using inductive method of qualitative data analysis. Results Respondents correctly recognized many symptoms of stroke and were aware of the sudden onset of symptoms. They were unaware of transient ischemic attacks. After stroke, healthcare was sought from private physicians, and physicians in the government run district hospital, or traditional herbal providers depending upon the accessibility, affordability, and perceived effectiveness of the therapy. Most of the respondents thought that stroke is a serious disease associated with disability as well as death and its occurrence in the community is increasing. However, only a few participants could correctly state how stroke occurs and its risk factors. Furthermore, many participants thought that stroke cannot be prevented as it occurs suddenly without any warning. Conclusion Rural people in Gadchiroli were aware of symptoms of stroke but awareness about the etiology and the risk factors was low. Suddenness of symptoms was perceived as a key barrier to taking any preventive action. Understanding such perceptions and addressing them can help improve counseling of patients by physicians and effectiveness of behavioral change communication to prevent stroke in rural areas.

Primary Care 2030: Creating an Enabling Ecosystem for Disruptive Primary Care Models to Achieve Universal Health Coverage in Low- and Middle-Income Countries.

Background: Forty years after Alma Ata, there is renewed commitment to strengthen primary health care as a foundation for achieving universal health coverage, but there is limited consensus on how to build strong primary health care systems to achieve these goals. Methods: We convened a diverse group of global stakeholders for a high-level dialogue on how to create an enabling ecosystem for disruptive primary care innovation. We focused our discussion on four themes: workforce innovation and strengthening; impactful use of data and technology; private sector engagement; and innovative financing mechanisms. Findings: Here, we present a summary of our convening's proceedings, with specific recommendations for strengthening primary health care systems within each of these four domains. Conclusions: In the wake of the Astana Declaration, there is global consensus that high-quality primary health care must be the foundation for universal health coverage. Significant disruptive innovation will be required to realize this goal. We offer our recommendations to the global community to catalyze further discourse and inform policy-making and program development on the path to Health for All by 2030.

Effect of a community-based intervention for cardiovascular risk factor control on stroke mortality in rural Gadchiroli, India: study protocol for a cluster randomised controlled trial.

BACKGROUND: Stroke has emerged as a leading cause of death in rural India. However, well-tested healthcare interventions to reduce stroke mortality in rural under-resourced settings are lacking. The aim of this study is to evaluate the effect of a community-based preventive intervention on stroke mortality in rural Gadchiroli, India. METHODS: The study is a two-arm, parallel group, cluster randomised controlled trial in which 32 villages will be randomised to the intervention and the enhanced usual care (EUC) arm. In the intervention arm, individuals ≥50 years of age will be screened for hypertension, diabetes and stroke by trained Community Health Workers (CHWs). Screened individuals who are positive will be referred to a mobile outreach clinic which will visit the intervention villages periodically. A physician in the clinic will confirm the diagnosis, provide guideline-based treatment and follow up patients. The CHWs will make home visits once a month to ensure medication compliance and counsel patients to reduce salt consumption and quit tobacco and alcohol. In the EUC arm, households will be provided information on the ill effects of tobacco use and steps to quit it. Individuals from both the arms will have access to the government's national programme for the prevention and control of non-communicable diseases, where treatment for hypertension, diabetes and preventive treatment after stroke is available at the nearest primary health centres (PHCs). The intervention will be implemented for 3.5 years. The primary outcome will be a reduction in stroke mortality in the last 2.5 years of the intervention. DISCUSSION: This trial will provide important information regarding the feasibility and effect of a community-based preventive intervention package on stroke mortality in a rural under-resourced setting and can inform India's non-communicable diseases prevention and control programme. If successful, such an intervention can be scaled up in the rural regions of India and other countries. TRIAL REGISTRATION: Clinical Trials Registry of India: CTRI/2015/12/006424. Registered on 8 December 2015.

A prospective study of causes of death in rural Gadchiroli, an underdeveloped district of India (2011-2013).

BACKGROUND: Reliable information on causes of death to understand health priorities is rare from rural underdeveloped regions of India but is needed to direct health care response. This prompted us to study causes of death in a rural region of Gadchiroli, one of the most underdeveloped districts of India. METHODS: Data on causes of death were collected from 86 villages between April 2011 and March 2013 using verbal autopsies. Two physicians independently assigned cause of death using the tenth revision of the International Classification of Disease and disagreement was resolved by a third physician. RESULTS: There were 1599 deaths over 188,308 person years of observation. The crude death rate was 8.5 (95% confidence interval (CI)=8.1-8.9). The five leading causes of death were diseases of the circulatory system (20.8%), with stroke being the leading cause (14.3%), infections and parasitic disorders (18.4%), injuries and other external causes of mortality (10%), peri-natal diseases (6.5%) and diseases of the respiratory system (6.4%). Non-communicable diseases (NCDs) accounted for 38.5%, infections and perinatal diseases for 28.3% and external causes including injuries for 10% of all deaths. CONCLUSIONS: Epidemiological transition with a shift in causes of deaths from communicable to NCDs has occurred even in a rural underdeveloped district like Gadchiroli. Public health system in rural India which focuses on infections and maternal and child health will now need to be strengthened urgently to face the triple challenge of communicable and non-communicable diseases as well as injuries.