Prem Mony

Prospective Study of One Million Deaths in India: Rationale, Design, and Validation Results

Background Over 75% of the annual estimated 9.5 million deaths in India occur in the home, and the large majority of these do not have a certified cause. India and other developing countries urgently need reliable quantification of the causes of death. They also need better epidemiological evidence about the relevance of physical (such as blood pressure and obesity), behavioral (such as smoking, alcohol, HIV-1 risk taking, and immunization history), and biological (such as blood lipids and gene polymorphisms) measurements to the development of disease in individuals or disease rates in populations. We report here on the rationale, design, and implementation of the worlds largest prospective study of the causes and correlates of mortality. Methods and Findings We will monitor nearly 14 million people in 2.4 million nationally representative Indian households (6.3 million people in 1.1 million households in the 1998–2003 sample frame and 7.6 million people in 1.3 million households in the 2004–2014 sample frame) for vital status and, if dead, the causes of death through a well-validated verbal autopsy (VA) instrument. About 300,000 deaths from 1998–2003 and some 700,000 deaths from 2004–2014 are expected; of these about 850,000 will be coded by two physicians to provide causes of death by gender, age, socioeconomic status, and geographical region. Pilot studies will evaluate the addition of physical and biological measurements, specifically dried blood spots. Preliminary results from over 35,000 deaths suggest that VA can ascertain the leading causes of death, reduce the misclassification of causes, and derive the probable underlying cause of death when it has not been reported. VA yields broad classification of the underlying causes in about 90% of deaths before age 70. In old age, however, the proportion of classifiable deaths is lower. By tracking underlying demographic denominators, the study permits quantification of absolute mortality rates. Household case-control, proportional mortality, and nested case-control methods permit quantification of risk factors. Conclusions This study will reliably document not only the underlying cause of child and adult deaths but also key risk factors (behavioral, physical, environmental, and eventually, genetic). It offers a globally replicable model for reliably estimating cause-specific mortality using VA and strengthens Indias flagship mortality monitoring system. Despite the misclassification that is still expected, the new cause-of-death data will be substantially better than that available previously.

Prevalence of a Healthy Lifestyle Among Individuals With Cardiovascular Disease in High-, Middle- and Low-Income Countries The Prospective Urban Rural Epidemiology (PURE) Study

IMPORTANCE Little is known about adoption of healthy lifestyle behaviors among individuals with a coronary heart disease (CHD) or stroke event in communities across a range of countries worldwide. OBJECTIVE To examine the prevalence of avoidance or cessation of smoking, eating a healthy diet, and undertaking regular physical activities by individuals with a CHD or stroke event. DESIGN, SETTING, AND PARTICIPANTS Prospective Urban Rural Epidemiology (PURE) was a large, prospective cohort study that used an epidemiological survey of 153,996 adults, aged 35 to 70 years, from 628 urban and rural communities in 3 high-income countries (HIC), 7 upper-middle-income countries (UMIC), 3 lower-middle-income countries (LMIC), and 4 low-income countries (LIC), who were enrolled between January 2003 and December 2009. MAIN OUTCOME MEASURES Smoking status (current, former, never), level of exercise (low, <600 metabolic equivalent task [MET]-min/wk; moderate, 600-3000 MET-min/wk; high, >3000 MET-min/wk), and diet (classified by the Food Frequency Questionnaire and defined using the Alternative Healthy Eating Index). RESULTS Among 7519 individuals with self-reported CHD (past event: median, 5.0 [interquartile range {IQR}, 2.0-10.0] years ago) or stroke (past event: median, 4.0 [IQR, 2.0-8.0] years ago), 18.5% (95% CI, 17.6%-19.4%) continued to smoke; only 35.1% (95% CI, 29.6%-41.0%) undertook high levels of work- or leisure-related physical activity, and 39.0% (95% CI, 30.0%-48.7%) had healthy diets; 14.3% (95% CI, 11.7%-17.3%) did not undertake any of the 3 healthy lifestyle behaviors and 4.3% (95% CI, 3.1%-5.8%) had all 3. Overall, 52.5% (95% CI, 50.7%-54.3%) quit smoking (by income country classification: 74.9% [95% CI, 71.1%-78.6%] in HIC; 56.5% [95% CI, 53.4%-58.6%] in UMIC; 42.6% [95% CI, 39.6%-45.6%] in LMIC; and 38.1% [95% CI, 33.1%-43.2%] in LIC). Levels of physical activity increased with increasing country income but this trend was not statistically significant. The lowest prevalence of eating healthy diets was in LIC (25.8%; 95% CI, 13.0%-44.8%) compared with LMIC (43.2%; 95% CI, 30.0%-57.4%), UMIC (45.1%, 95% CI, 30.9%-60.1%), and HIC (43.4%, 95% CI, 21.0%-68.7%). CONCLUSION AND RELEVANCE Among a sample of patients with a CHD or stroke event from countries with varying income levels, the prevalence of healthy lifestyle behaviors was low, with even lower levels in poorer countries.

Comparison of the efficacies of loop-mediated isothermal amplification, fluorescence smear microscopy and culture for the diagnosis of tuberculosis.

Background Despite the advent of novel diagnostic techniques, smear microscopy remains as the most practical test available in resource-limited settings for tuberculosis (TB) diagnosis. Due to the low sensitivity of microscopy and the long time required for culture, feasible and accessible rapid diagnostic methods are urgently needed. Loop-mediated Isothermal Amplification (LAMP) is a promising nucleic-acid amplification assay, which could be accessible, cost-effective and more suited for use with unpurified samples. Methodology/Principal Findings In the current study, the objective was to assess the efficacy of a LAMP assay for tuberculosis compared with fluorescence smear microscopy as well as Löwenstein-Jensen (LJ) and Mycobacteria Growth Indicator Tube (MGIT) cultures for the diagnosis of pulmonary tuberculosis using sputum samples. Smear microscopy and culture were performed for decontaminated and concentrated sputum from TB suspects and the LAMP was also performed on these specimens. The LAMP and smear microscopy were compared, in series and in parallel, to culture. LAMP and smear microscopy showed sensitivities of 79.5% and 82.1% respectively and specificities of 93.8% and 96.9% respectively, compared to culture. LAMP and smear in series had sensitivity and specificity of 79.5% and 100.0% respectively. LAMP and smear in parallel had sensitivity and specificity of 82.1% and 90.6% respectively. Conclusions/Significance The overall efficacies of LAMP and fluorescence smear microscopy in the current study were high and broadly similar. LAMP and smear in series had high specificity (100.0%) and can be used as a rule-in test combination. However, the performance of LAMP in smear negative samples was found to be insufficient.

Prevalence and correlates of Herpes Simplex Virus-2 and syphilis infections in the general population in India

Objectives To determine the prevalence and correlates of Herpes Simplex Virus-2 (HSV-2) and syphilis infections in the general population in India. Methods 2456 adults were surveyed in Hyderabad, Bangalore and Chandigarh in India. Socio-demographic and lifestyle characteristics were obtained through a questionnaire, and a dried blood spot (DBS) was collected from all individuals aged 18 years and over; sexual behaviour was collected from those aged 18–49 years. DBS samples were tested for HSV-2 and syphilis serology. The association between HSV-2 and syphilis infections with socio-demographic and behavioural variables was analysed using multivariable logistic regression. Results The prevalence of HSV-2 and syphilis was 10.1% and 1.7%, respectively. Geographic differences in HSV-2 prevalence were significant, while for syphilis it was comparable. Urban–rural differences in prevalence were only seen for syphilis. For both infections, the prevalence between males and females was not significantly different. In males and females, HSV-2 prevalence increased significantly with increasing age; for syphilis, a slight trend was seen only in females. In a multivariable analysis, HSV-2 infection in males and females was associated with site, religion and testing positive for syphilis, in addition to reporting ≥2 lifetime partners in the previous year among males and being ever married or having had sex with a non-regular partner in the last year among females. Conclusions The burden and geographic heterogeneity of HSV-2 and syphilis infections in India are significant. A national household and DBS-based sexually transmitted infection (STI) surveillance system would enable monitoring, especially in relation to the HIV epidemic, and planning of evidence-based prevention and treatment programmes.

Availability and Distribution of Emergency Obstetric Care Services in Karnataka State, South India: Access and Equity Considerations

Background As part of efforts to reduce maternal deaths in Karnataka state, India, there has been a concerted effort to increase institutional deliveries. However, little is known about the quality of care in these healthcare facilities. We investigated the availability and distribution of emergency obstetric care (EmOC) services in eight northern districts of Karnataka state in south India. Methods & Findings We undertook a cross-sectional study of 444 government and 422 private health facilities, functional 24-hours-a-day 7-days-a-week. EmOC availability and distribution were evaluated for 8 districts and 42 taluks (sub-districts) during the year 2010, based on a combination of self-reporting, record review and direct observation. Overall, the availability of EmOC services at the sub-state level [EmOC = 5.9/500,000; comprehensive EmOC (CEmOC) = 4.5/500,000 and basic EmOC (BEmOC) = 1.4/500,000] was seen to meet the benchmark. These services however were largely located in the private sector (90% of CEmOC and 70% of BemOC facilities). Thirty six percent of private facilities and six percent of government facilities were EmOC centres. Although half of eight districts had a sufficient number of EmOC facilities and all eight districts had a sufficient number of CEmOC facilities, only two-fifths of the 42 taluks had a sufficient number of EmOC facilities. With the private facilities being largely located in select towns only, the ‘non-headquarter’ taluks and ‘backward’ taluks suffered from a marked lack of coverage of these services. Spatial mapping further helped identify the clustering of a large number of contiguous taluks without adequate government EmOC facilities in northeastern Karnataka. Conclusions In conclusion, disaggregating information on emergency obstetric care service availability at district and subdistrict levels is critical for health policy and planning in the Indian setting. Reducing maternal deaths will require greater attention by the government in addressing inequities in the distribution of emergency obstetric care services.

Assessment of facility readiness and provider preparedness for dealing with postpartum haemorrhage and pre-eclampsia/eclampsia in public and private health facilities of northern Karnataka, India: a cross-sectional study

BackgroundThe maternal mortality ratio in India has been declining over the past decade, but remains unacceptably high at 212 per 100,000 live births. Postpartum haemorrhage (PPH) and pre- eclampsia/eclampsia contribute to 40% of all maternal deaths. We assessed facility readiness and provider preparedness to deal with these two maternal complications in public and private health facilities of northern Karnataka state, south India.MethodsWe undertook a cross-sectional study of 131 primary health centres (PHCs) and 148 higher referral facilities (74 public and 74 private) in eight districts of the region. Facility infrastructure and providers’ knowledge related to screening and management of complications were assessed using facility checklists and test cases, respectively. We also attempted an audit of case sheets to assess provider practice in the management of complications. Chi square tests were used for comparing proportions.Results84.5% and 62.9% of all facilities had atleast one doctor and three nurses, respectively; only 13% of higher facilities had specialists. Magnesium sulphate, the drug of choice to control convulsions in eclampsia was available in 18% of PHCs, 48% of higher public facilities and 70% of private facilities. In response to the test case on eclampsia, 54.1% and 65.1% of providers would administer anti-hypertensives and magnesium sulphate, respectively; 24% would administer oxygen and only 18% would monitor for magnesium sulphate toxicity. For the test case on PPH, only 37.7% of the providers would assess for uterine tone, and 40% correctly defined early PPH. Specialists were better informed than the other cadres, and the differences were statistically significant. We experienced generally poor response rates for audits due to non-availability and non-maintenance of case sheets.ConclusionsAddressing gaps in facility readiness and provider competencies for emergency obstetric care, alongside improving coverage of institutional deliveries, is critical to improve maternal outcomes. It is necessary to strengthen providers’ clinical and problem solving skills through capacity building initiatives beyond pre-service training, such as through onsite mentoring and supportive supervision programs. This should be backed by a health systems response to streamline staffing and supply chains in order to improve the quality of emergency obstetric care.

Nurse Mentors to Advance Quality Improvement in Primary Health Centers: Lessons From a Pilot Program in Northern Karnataka, India

Trained nurse mentors catalyzed quality improvements in facility-based maternal and newborn care by: (1) encouraging use of self-assessment checklists and team-based problem solving, (2) introducing case sheets to ensure adherence to clinical guidelines, and (3) strengthening clinical skills through on-site demonstrations and bedside teaching. Inadequate leadership and staffing were challenges in some facilities. Some social norms, such as client resistance to referral and to staying 48 hours after delivery, also impact quality and mandate community mobilization efforts. Trained nurse mentors catalyzed quality improvements in facility-based maternal and newborn care by: (1) encouraging use of self-assessment checklists and team-based problem solving, (2) introducing case sheets to ensure adherence to clinical guidelines, and (3) strengthening clinical skills through on-site demonstrations and bedside teaching. Inadequate leadership and staffing were challenges in some facilities. Some social norms, such as client resistance to referral and to staying 48 hours after delivery, also impact quality and mandate community mobilization efforts. High-quality care during labor, delivery, and the postpartum period is critically important since maternal and child morbidity and mortality are linked to complications that arise during these stages. A nurse mentoring program was implemented in northern Karnataka, India, to improve quality of services at primary health centers (PHCs), the lowest level in the public health system that offers basic obstetric care. The intervention, conducted between August 2012 and July 2014, employed 53 full-time nurse mentors and was scaled-up in 385 PHCs in 8 poor rural districts. Each mentor was responsible for 6 to 8 PHCs and conducted roughly 6 mentoring visits per PHC in the first year. This paper reports the results of a qualitative inquiry, conducted between September 2012 and April 2014, assessing the programs successes and challenges from the perspective of mentors and PHC teams. Data were gathered through 13 observations, 9 focus group discussions with mentors, and 25 individual and group interviews with PHC nurses, medical officers, and district health officers. Mentors and PHC staff and leaders reported a number of successes, including development of rapport and trust between mentors and PHC staff, introduction of team-based quality improvement processes, correct and consistent use of a new case sheet to ensure adherence to clinical guidelines, and increases in staff nurses’ knowledge and skills. Overall, nurses in many PHCs reported an increased ability to provide care according to guidelines and to handle maternal and newborn complications, along with improvements in equipment and supplies and referral management. Challenges included high service delivery volumes and/or understaffing at some PHCs, unsupportive or absent PHC leadership, and cultural practices that impacted quality. Comprehensive mentoring can build competence and improve performance by combining on-the-job clinical and technical support, applying quality improvement principles, and promoting team-based problem solving.

Clinico-epidemiological profile of tobacco users attending a tobacco cessation clinic in a teaching hospital in Bangalore city

Background: Tobacco-attributable mortality in India is estimated to be at least 10%. Tobacco cessation is more likely to avert millions of deaths before 2050 than prevention of tobacco use initiation. Objective: To describe the clinico-epidemiological profile of attendees of a tobacco cessation clinic in a teaching hospital in Bangalore city. Materials and Methods: A descriptive study of 189 attendees seen over 2 years in the Tobacco Cessation Clinic of a tertiary-care teaching hospital in Bangalore, with information on socio demographic characteristics, tobacco-use details, nicotine dependence, family/medical history, past quit attempts, baseline stage-of-change, and treatment initiated. Results: Only 5% were ‘walk-in’ patients; 98% of attendees were smokers; 97% were males. The mean (±SD) age of attendees was 48.0 (±14.0) years. Most participants were married (88%), and predominantly urban (69%). About 62% had completed at least 8 years of schooling. Two-thirds of smokers reported high levels of nicotine dependence (Fagerström score >5/10). About 43% of patients had attempted quitting earlier. Four-fifths (79%) of tobacco-users reported a family member using tobacco. Commonly documented comorbidities included: Chronic respiratory disease (44%), hypertension (23%), diabetes (12%), tuberculosis (9%), myocardial infarction (2%), stroke (1%), sexual dysfunction (1%) and cancer (0.5%). About 52% reported concomitant alcohol use. At baseline, patients’ motivational stage was: Precontemplation (14%), contemplation (48%), preparation/action (37%) and maintenance (1%). Treatment modalities started were: Counseling alone (41%), nicotine replacement therapy alone (NRT) (34%), medication alone (13%), and NRT+medication (12%). Conclusions: This is the first study of the baseline profile of patients attending a tobacco cessation clinic located within a chest medicine department in India. Important determinants of outcome have been captured for follow-up and prospective documentation of outcomes.

Effectiveness of Onsite Nurse Mentoring in Improving Quality of Institutional Births in the Primary Health Centres of High Priority Districts of Karnataka, South India: A Cluster Randomized Trial

Background In India, although the proportion of institutional births is increasing, there are concerns regarding quality of care. We assessed the effectiveness of a nurse-led onsite mentoring program in improving quality of care of institutional births in 24/7 primary health centres (PHCs that are open 24 hours a day, 7 days a week) of two high priority districts in Karnataka state, South India. Primary outcomes were improved facility readiness and provider preparedness in managing institutional births and associated complications during child birth. Methods All functional 24/7 PHCs in the two districts were included in the study. We used a parallel, cluster randomized trial design in which 54 of 108 facilities received six onsite mentoring visits, along with an initial training update and specially designed case sheets for providers; the control arm received just the initial training update and the case sheets. Pre- and post-intervention surveys were administered in April-2012 and August-2013 using facility audits, provider interviews and case sheet audits. The provider interviews were administered to all staff nurses available at the PHCs and audits were done of all the filled case sheets during the month prior to data collection. In addition, a cost analysis of the intervention was undertaken. Results Between the surveys, we achieved coverage of 100% of facilities and 91.2% of staff nurse interviews. Since the case sheets were newly designed, case-sheet audit data were available only from the end line survey for about 80.2% of all women in the intervention facilities and 57.3% in the control facilities. A higher number of facilities in the intervention arm had all appropriate drugs, equipment and supplies to deal with gestational hypertension (19 vs.3, OR (odds ratio) 9.2, 95% C.I 2.5 to33.6), postpartum haemorrhage (29 vs. 12, OR 3.7, 95% C.I 1.6 to8.3); and obstructed labour (25 vs.9, OR 3.4, 95% CI 1.6 to8.3). The providers in the intervention arm had better knowledge of active management of the third stage of labour (82.4% vs.35.8%, AOR (adjusted odds ratio) 10, 95% C.I 5.5 to 18.2); management of maternal sepsis (73.5% vs. 10.9%, AOR 36.1, 95% C.I 13.6 to 95.9); neonatal resuscitation (48.5% vs.11.7%, AOR 10.7, 95% C.I 4.6 to 25.0) and low birth weight newborn care (58.1% vs. 40.9%, AOR 2.4, 95% C.I 1.2 to 4.7). The case sheet audits revealed that providers in the intervention arm showed greater compliance with the protocols during labour monitoring (77.3% vs. 32.1%, AOR 25.8, 95% C.I 9.6 to 69.4); delivery and immediate post-partum care for mothers (78.6% vs. 31.8%, AOR 22.1, 95% C.I 8.0 to 61.4) and for newborns (73.9% vs. 32.8%, AOR 24.1, 95% C.I 8.1 to 72.0). The cost analysis showed that the intervention cost an additional

Estimation of perinatal mortality rate for institutional births in Rajasthan state, India, using capture-recapture technique.

5.60 overall per delivery. Conclusions The mentoring program successfully improved provider preparedness and facility readiness to deal with institutional births and associated complications. It is feasible to improve the quality of institutional births at a large operational scale, without substantial incremental costs. Trial Registration ClinicalTrials.gov NCT02004912