Rotavirus is the most common cause of moderate-to-severe infant diarrhoea in developing countries... more Rotavirus is the most common cause of moderate-to-severe infant diarrhoea in developing countries, resulting in enormous morbidity, mortality, and economic burden. A bovine-human reassortant pentavalent rotavirus vaccine (BRV-PV) targeting the globally most common strains was developed in India and tested in a randomized, double-blind, placebo-controlled end-point driven Phase III efficacy clinical trial implemented at six sites across India. Infants 6 to 8 weeks of age were randomized (1:1) to receive three oral doses of BRV-PV or placebo at 6, 10, and 14 weeks of age along with routine vaccines. Home visit surveillance was conducted to detect severe rotavirus gastroenteritis (SRVGE) and safety outcomes until the children reached two years of age. A total of 3749 infants received BRV-PV while 3751 received placebo. At the time of the primary end-point (when the minimum number of cases needed for analysis were accrued) the vaccine efficacy against SRVGE was 36% (95% CI 11.7, 53.6, p = 0.0067) in the per protocol (PP) analysis, and 41.9% (95% CI 21.1, 57.3, p = 0.0005) in the intent to treat (ITT) analysis. Vaccine efficacy over the entire follow-up period (until children reached two years of age) was 39.5% (95% CI 26.7, 50, p < 0.0001) in the PP analysis and 38.8% (95% CI, 26.4, 49, p < 0.0001) in the ITT analysis. Vaccine efficacy against the very severe rotavirus cases (VSRVGE, Vesikari score ! 16) was 60.5% (95% CI 17.7, 81, p = 0.0131) at the time of the primary analysis and 54.7% (95% CI 29.7, 70.8, p = 0.0004) for the complete follow-period in the PP population. The incidence of solicited, unsolicited, and serious adverse events were similar in both the vaccine and placebo groups. Likewise, the number of intussusceptions and deaths were similar between both groups. Thus, BRV-PV is an effective, well tolerated and safe vaccine in Indian infants. (Trial registration: Clinical Trials.Gov [NCT 02133690] and Clinical Trial Registry of India [CTRI/2013/05/003667]).
Indian journal of community medicine : official publication of Indian Association of Preventive & Social Medicine
Preface With changing global and health environment, discipline of Community Medicine (CM) needs ... more Preface With changing global and health environment, discipline of Community Medicine (CM) needs to be made more relevant to India’s need. This declaration is prepared to provide much-needed direction to the discipline and aims at strengthening the teaching of CM by creating better understanding of the discipline, its roles, scope, and functions of CM specialist; to the undergraduate and postgraduate students as well as the faculty of CM. It also aims to build the capacity of the CM department of medical colleges. This declaration is first in the series of activities planned by the Indian Association of Preventive and Social Medicine (IAPSM) core committee in this direction.
Objective To determine the clinical manifestations, risk factors, treatment modalities and matern... more Objective To determine the clinical manifestations, risk factors, treatment modalities and maternal outcomes in pregnant women with lab-confirmed COVID-19 and compare it with COVID-19 negative pregnant women in same age group. Design Multicentric case-control study. Data sources Ambispective primary data collection through paper-based forms from 20 tertiary care centres across India between April and November 2020. Study population All pregnant women reporting to the centres with a lab-confirmed COVID-19 positive result matched with controls. Data quality Dedicated research officers extracted hospital records, using modified WHO Case Record Forms (CRF) and verified for completeness and accuracy. Statistical analysis Data converted to excel files and statistical analyses done using STATA 16 (StataCorp, TX, USA). Odds ratios (ORs) with 95% confidence intervals (CI) estimated using unconditional logistic regression. Results A total of 76,264 women delivered across 20 centres during the...
BACKGROUND Low-and-Middle income countries are facing the emerging burden of chronic non-communic... more BACKGROUND Low-and-Middle income countries are facing the emerging burden of chronic non-communicable diseases (NCDs). Apart from high costs to the health system, NCDs also afflict high out of pocket expenditure. The risk factors for NCDs are initiated at an early age. The key to the control of the global epidemic of NCDs is primary prevention based on comprehensive community-based programs. OBJECTIVE To develop, implement and evaluate the effect of a participatory health promotion initiative utilizing the existing mechanism of Village Health Nutrition and Sanitation Committees (VHNSCs), Women’s Self-help Groups (SHGs) and Schools on modifiable risk factors for NCDs among young people (10-30 years). METHODS The proposed type II hybrid effectiveness/ implementation cluster randomized field trial will be conducted in the catchment area of four Primary Health Centers (PHCs) in Wardha district of India each representing one arm of the study. Each of the four PHCs will be randomly alloca...
Objective. To find out awareness of mothers about newborn danger signs and their health care seek... more Objective. To find out awareness of mothers about newborn danger signs and their health care seeking behavior for sick newborns in the peri urban field practice area of Urban Health Centre in Wardha. Methods. Triangulated study of quantitative (survey) and qualitative (mapping, pair-wise ranking exercise) methods were undertaken. 72 identified mothers of children (0-11 months) in social mapping exercise were interviewed by trained social workers using pre-designed and pre-tested questionnaire and by paying house to house visits. The structured questionnaire covered information on newborn danger signs, health care seeking and socio-demographic information. The data was analyzed by using Epi_info software package. A pair-wise ranking exercise for assessment of preferred health care facility for sick newborn was undertaken with the group of purposively selected mothers. Results. Out of 72 mothers, 29 (40.3%), 16 (22.2%) and 10 (13.9%) identified difficulty in breathing, poor sucking and lethargy/unconsciousness as newborn danger signs respectively. Only 7(9.7%) and 2 (2.8%) identified convulsion and hypothermia as newborn danger signs respectively. About 27 (37.5%) babies were sick during newborn period. About 11(15.3%) and 8 (11.1%) were reported to have poor sucking and difficulty in breathing respectively. All sick newborns with danger signs were taken to the doctor and only two mothers consulted faith healer for treatment. Conclusion. Considering the poor awareness of mothers regarding newborn danger signs, there is need for raising awareness building which required for early recognition and prompt treatment. Apart from strengthening government health facilities, the capacity of intermediate non government health care providers should be developed for newborn care.
A B S T R A C T Background and Objectives: Mahatma Gandhi Institute of Medical Sciences (MGIMS), ... more A B S T R A C T Background and Objectives: Mahatma Gandhi Institute of Medical Sciences (MGIMS), Sewagram, India's first rural medical institute, has been implementing its community-based public health teaching with the aim of building a physician workforce for the rural poor. For the past four decades, the MGIMS has organized and run the Re-orientation of Medical Education
Objectives: To assess the effect of the probiotic VSL#3 in prevention of neonatal sepsis in low b... more Objectives: To assess the effect of the probiotic VSL#3 in prevention of neonatal sepsis in low birthweight (LBW) infants. Design: Randomised, double-blind, placebo-controlled trial. Setting: Community setting in rural India. Participants: LBW infants aged 3-7 days. Interventions: Infants were randomised to receive probiotic (VSL#3, 10 billion colony-forming units (cfu)) or placebo for 30 days, and were followed up for 2 months. Main outcome measure: Possible serious bacterial infection (PSBI) as per the Integrated Management of Neonatal Childhood Illnesses algorithm, as diagnosed by fieldworkers/physicians. Results: 668 infants were randomised to VSL#3 and 672 to placebo. By intention-to-treat analysis, the risk of PSBI among infants in the overall population of LBW infants was not statistically significant (RR 0.79 (95% CI 0.56 to 1.03)). Probiotics reduced median days of hospitalisation (6 days vs 3 days in probiotics) (p=0.018) but not the risk of hospitalisation (RR 0.66 (95% CI 0.42 to 1.04). The onset of PSBI in 10% of infants occurred on the 40th day in the probiotics arm versus the 25th day in the control arm (p=0.063). Conclusions: Daily supplementation of LBW infants with probiotics VSL#3 (10 billion cfu) for 30 days led to a non-significant 21% reduction in risk of neonatal sepsis. A larger study with sufficient power and a more specific primary end point is warranted to confirm the preventive effect of VSL#3 on neonatal sepsis in LBW infants.
The accuracy of the Content should not be relied upon and should be independently verified with p... more The accuracy of the Content should not be relied upon and should be independently verified with primary sources of information. Taylor and Francis shall not be liable for any losses, actions, claims, proceedings, demands, costs, expenses, damages, and other liabilities whatsoever or howsoever caused arising directly or indirectly in connection with, in relation to or arising out of the use of the Content. This article may be used for research, teaching, and private study purposes. Any substantial or systematic reproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in any form to anyone is expressly forbidden.
Indian journal of clinical biochemistry : IJCB, 1997
Malaria contributes a most stimulating chapter in the annals of biological parasitism. At present... more Malaria contributes a most stimulating chapter in the annals of biological parasitism. At present the disease is endemic in 91 countries with about 40% of world population at risk. Among all infections malaria continues to be one of the biggest contributors to disease burden in terms of morbidity, suffering and deaths specially in Africa. By lowering the productivity it is closely linked to poverty and contributes significantly to stunting social and economic development.We, in South East Asia, are living in paradoxical situation, on one side we spent large sums and energy to control/eradicate malaria and on the other hand we simultaneously create malariogenic conditions in the process of development efforts eg. irrigation canals, water supply scheme and urbanisation.The disease is endemic in all the seven countries of South East Asia with P.f.% ranging from 2.47% in Nepaa to 55% in Pakistan. In India although the total number of cases are almost static in last 10 years however the ...
Objective: We examined the men's attitudes and perceptions toward the concept of nonsurgical fema... more Objective: We examined the men's attitudes and perceptions toward the concept of nonsurgical female permanent contraception (NSPC), or novel approaches to permanent contraception (PC) that do not require incisions or surgical equipment/hysteroscope. Study design: Cross-sectional survey of married/partnered men in Portland, OR and rural eastern Maharashtra, India. Descriptive analysis was performed. Results: In India (N=150), most men (80%) anticipated their partners would undergo PC in the future, compared to 30% in Portland (N=170). About a third (39.6% in India, 82% in Portland) reported being uncomfortable with PC for partners due to the need for surgery. Most men (85% in India, 82% in Portland) expressed a preference for a hypothetical new method of female NSPC over surgery, if safe and effective. Conclusion: Most men sampled in two diverse settings expressed interest in NSPC for women. Implications: Men's perceptions of new female contraceptive methods are important to the contraceptive development process. Men may find a safe and effective nonsurgical method of permanent female contraception more acceptable than surgical PC.
In India breast feeding in rural areas appears to be shaped by the health beliefs of a community,... more In India breast feeding in rural areas appears to be shaped by the health beliefs of a community, which are further influenced by social, cultural and economic factors. One of such tradition is prelacteal feeding which is widely prevalent since ancient times. The present study was aimed to find out the practice of prelacteal feeding and various factors which influence this practice. The study on analysis showed that 45% (90) mothers gave prelacteal feeds to their newborns in the form of sugar water, gur water or cow's milk. Sugar water was common amongst mothers belonging to nuclear family (49%) whereas gur water was given mostly by joint family mothers (75.70%). Parity and family type had no significant effect on this practice, however the effect of literacy was found to be significantly related to the practice.
Objective: To see the usefulness of verbal autopsy and in assessing the cause of deaths among inf... more Objective: To see the usefulness of verbal autopsy and in assessing the cause of deaths among infants and identify gaps in reporting system in 4 PHCs in India. Methodology: The study incorporated all the infant deaths, which occurred in a one-year period from 2 nd Jan 2004 to 1 st Jan 2005 in Yavatmal district in Maharashtra. This data was compared with the corresponding district data and the gaps in reporting were identified site-wise. Results: Medical certification of cause of death was done in only 12% of deaths. Under reporting was more than 50% in 2 PHCs and the IMR was found to be 59 per 1000 live births in contrast to 38 per 1000, given by the district authorities. Prematurity and LBW contributed for the 47% deaths during the early neonatal period. In post neonatal period mostly infectious causes like ARI contributed for 35% followed by CNS infections (12%). Majority (73%) of the 90 infant deaths were delivered at home and were attended by unskilled personnel (72%). Overall there were 63% deaths which occurred in the early neonatal period, 13% in late neonatal period and 23% in post neonatal period. Conclusions: Verbal autopsy can be used to give information for the health planners to prioritize health services based on the mortality pattern of an area and for collecting information for action at the local level.
Rotavirus is the most common cause of moderate-to-severe infant diarrhoea in developing countries... more Rotavirus is the most common cause of moderate-to-severe infant diarrhoea in developing countries, resulting in enormous morbidity, mortality, and economic burden. A bovine-human reassortant pentavalent rotavirus vaccine (BRV-PV) targeting the globally most common strains was developed in India and tested in a randomized, double-blind, placebo-controlled end-point driven Phase III efficacy clinical trial implemented at six sites across India. Infants 6 to 8 weeks of age were randomized (1:1) to receive three oral doses of BRV-PV or placebo at 6, 10, and 14 weeks of age along with routine vaccines. Home visit surveillance was conducted to detect severe rotavirus gastroenteritis (SRVGE) and safety outcomes until the children reached two years of age. A total of 3749 infants received BRV-PV while 3751 received placebo. At the time of the primary end-point (when the minimum number of cases needed for analysis were accrued) the vaccine efficacy against SRVGE was 36% (95% CI 11.7, 53.6, p = 0.0067) in the per protocol (PP) analysis, and 41.9% (95% CI 21.1, 57.3, p = 0.0005) in the intent to treat (ITT) analysis. Vaccine efficacy over the entire follow-up period (until children reached two years of age) was 39.5% (95% CI 26.7, 50, p < 0.0001) in the PP analysis and 38.8% (95% CI, 26.4, 49, p < 0.0001) in the ITT analysis. Vaccine efficacy against the very severe rotavirus cases (VSRVGE, Vesikari score ! 16) was 60.5% (95% CI 17.7, 81, p = 0.0131) at the time of the primary analysis and 54.7% (95% CI 29.7, 70.8, p = 0.0004) for the complete follow-period in the PP population. The incidence of solicited, unsolicited, and serious adverse events were similar in both the vaccine and placebo groups. Likewise, the number of intussusceptions and deaths were similar between both groups. Thus, BRV-PV is an effective, well tolerated and safe vaccine in Indian infants. (Trial registration: Clinical Trials.Gov [NCT 02133690] and Clinical Trial Registry of India [CTRI/2013/05/003667]).
Indian journal of community medicine : official publication of Indian Association of Preventive & Social Medicine
Preface With changing global and health environment, discipline of Community Medicine (CM) needs ... more Preface With changing global and health environment, discipline of Community Medicine (CM) needs to be made more relevant to India’s need. This declaration is prepared to provide much-needed direction to the discipline and aims at strengthening the teaching of CM by creating better understanding of the discipline, its roles, scope, and functions of CM specialist; to the undergraduate and postgraduate students as well as the faculty of CM. It also aims to build the capacity of the CM department of medical colleges. This declaration is first in the series of activities planned by the Indian Association of Preventive and Social Medicine (IAPSM) core committee in this direction.
Objective To determine the clinical manifestations, risk factors, treatment modalities and matern... more Objective To determine the clinical manifestations, risk factors, treatment modalities and maternal outcomes in pregnant women with lab-confirmed COVID-19 and compare it with COVID-19 negative pregnant women in same age group. Design Multicentric case-control study. Data sources Ambispective primary data collection through paper-based forms from 20 tertiary care centres across India between April and November 2020. Study population All pregnant women reporting to the centres with a lab-confirmed COVID-19 positive result matched with controls. Data quality Dedicated research officers extracted hospital records, using modified WHO Case Record Forms (CRF) and verified for completeness and accuracy. Statistical analysis Data converted to excel files and statistical analyses done using STATA 16 (StataCorp, TX, USA). Odds ratios (ORs) with 95% confidence intervals (CI) estimated using unconditional logistic regression. Results A total of 76,264 women delivered across 20 centres during the...
BACKGROUND Low-and-Middle income countries are facing the emerging burden of chronic non-communic... more BACKGROUND Low-and-Middle income countries are facing the emerging burden of chronic non-communicable diseases (NCDs). Apart from high costs to the health system, NCDs also afflict high out of pocket expenditure. The risk factors for NCDs are initiated at an early age. The key to the control of the global epidemic of NCDs is primary prevention based on comprehensive community-based programs. OBJECTIVE To develop, implement and evaluate the effect of a participatory health promotion initiative utilizing the existing mechanism of Village Health Nutrition and Sanitation Committees (VHNSCs), Women’s Self-help Groups (SHGs) and Schools on modifiable risk factors for NCDs among young people (10-30 years). METHODS The proposed type II hybrid effectiveness/ implementation cluster randomized field trial will be conducted in the catchment area of four Primary Health Centers (PHCs) in Wardha district of India each representing one arm of the study. Each of the four PHCs will be randomly alloca...
Objective. To find out awareness of mothers about newborn danger signs and their health care seek... more Objective. To find out awareness of mothers about newborn danger signs and their health care seeking behavior for sick newborns in the peri urban field practice area of Urban Health Centre in Wardha. Methods. Triangulated study of quantitative (survey) and qualitative (mapping, pair-wise ranking exercise) methods were undertaken. 72 identified mothers of children (0-11 months) in social mapping exercise were interviewed by trained social workers using pre-designed and pre-tested questionnaire and by paying house to house visits. The structured questionnaire covered information on newborn danger signs, health care seeking and socio-demographic information. The data was analyzed by using Epi_info software package. A pair-wise ranking exercise for assessment of preferred health care facility for sick newborn was undertaken with the group of purposively selected mothers. Results. Out of 72 mothers, 29 (40.3%), 16 (22.2%) and 10 (13.9%) identified difficulty in breathing, poor sucking and lethargy/unconsciousness as newborn danger signs respectively. Only 7(9.7%) and 2 (2.8%) identified convulsion and hypothermia as newborn danger signs respectively. About 27 (37.5%) babies were sick during newborn period. About 11(15.3%) and 8 (11.1%) were reported to have poor sucking and difficulty in breathing respectively. All sick newborns with danger signs were taken to the doctor and only two mothers consulted faith healer for treatment. Conclusion. Considering the poor awareness of mothers regarding newborn danger signs, there is need for raising awareness building which required for early recognition and prompt treatment. Apart from strengthening government health facilities, the capacity of intermediate non government health care providers should be developed for newborn care.
A B S T R A C T Background and Objectives: Mahatma Gandhi Institute of Medical Sciences (MGIMS), ... more A B S T R A C T Background and Objectives: Mahatma Gandhi Institute of Medical Sciences (MGIMS), Sewagram, India's first rural medical institute, has been implementing its community-based public health teaching with the aim of building a physician workforce for the rural poor. For the past four decades, the MGIMS has organized and run the Re-orientation of Medical Education
Objectives: To assess the effect of the probiotic VSL#3 in prevention of neonatal sepsis in low b... more Objectives: To assess the effect of the probiotic VSL#3 in prevention of neonatal sepsis in low birthweight (LBW) infants. Design: Randomised, double-blind, placebo-controlled trial. Setting: Community setting in rural India. Participants: LBW infants aged 3-7 days. Interventions: Infants were randomised to receive probiotic (VSL#3, 10 billion colony-forming units (cfu)) or placebo for 30 days, and were followed up for 2 months. Main outcome measure: Possible serious bacterial infection (PSBI) as per the Integrated Management of Neonatal Childhood Illnesses algorithm, as diagnosed by fieldworkers/physicians. Results: 668 infants were randomised to VSL#3 and 672 to placebo. By intention-to-treat analysis, the risk of PSBI among infants in the overall population of LBW infants was not statistically significant (RR 0.79 (95% CI 0.56 to 1.03)). Probiotics reduced median days of hospitalisation (6 days vs 3 days in probiotics) (p=0.018) but not the risk of hospitalisation (RR 0.66 (95% CI 0.42 to 1.04). The onset of PSBI in 10% of infants occurred on the 40th day in the probiotics arm versus the 25th day in the control arm (p=0.063). Conclusions: Daily supplementation of LBW infants with probiotics VSL#3 (10 billion cfu) for 30 days led to a non-significant 21% reduction in risk of neonatal sepsis. A larger study with sufficient power and a more specific primary end point is warranted to confirm the preventive effect of VSL#3 on neonatal sepsis in LBW infants.
The accuracy of the Content should not be relied upon and should be independently verified with p... more The accuracy of the Content should not be relied upon and should be independently verified with primary sources of information. Taylor and Francis shall not be liable for any losses, actions, claims, proceedings, demands, costs, expenses, damages, and other liabilities whatsoever or howsoever caused arising directly or indirectly in connection with, in relation to or arising out of the use of the Content. This article may be used for research, teaching, and private study purposes. Any substantial or systematic reproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in any form to anyone is expressly forbidden.
Indian journal of clinical biochemistry : IJCB, 1997
Malaria contributes a most stimulating chapter in the annals of biological parasitism. At present... more Malaria contributes a most stimulating chapter in the annals of biological parasitism. At present the disease is endemic in 91 countries with about 40% of world population at risk. Among all infections malaria continues to be one of the biggest contributors to disease burden in terms of morbidity, suffering and deaths specially in Africa. By lowering the productivity it is closely linked to poverty and contributes significantly to stunting social and economic development.We, in South East Asia, are living in paradoxical situation, on one side we spent large sums and energy to control/eradicate malaria and on the other hand we simultaneously create malariogenic conditions in the process of development efforts eg. irrigation canals, water supply scheme and urbanisation.The disease is endemic in all the seven countries of South East Asia with P.f.% ranging from 2.47% in Nepaa to 55% in Pakistan. In India although the total number of cases are almost static in last 10 years however the ...
Objective: We examined the men's attitudes and perceptions toward the concept of nonsurgical fema... more Objective: We examined the men's attitudes and perceptions toward the concept of nonsurgical female permanent contraception (NSPC), or novel approaches to permanent contraception (PC) that do not require incisions or surgical equipment/hysteroscope. Study design: Cross-sectional survey of married/partnered men in Portland, OR and rural eastern Maharashtra, India. Descriptive analysis was performed. Results: In India (N=150), most men (80%) anticipated their partners would undergo PC in the future, compared to 30% in Portland (N=170). About a third (39.6% in India, 82% in Portland) reported being uncomfortable with PC for partners due to the need for surgery. Most men (85% in India, 82% in Portland) expressed a preference for a hypothetical new method of female NSPC over surgery, if safe and effective. Conclusion: Most men sampled in two diverse settings expressed interest in NSPC for women. Implications: Men's perceptions of new female contraceptive methods are important to the contraceptive development process. Men may find a safe and effective nonsurgical method of permanent female contraception more acceptable than surgical PC.
In India breast feeding in rural areas appears to be shaped by the health beliefs of a community,... more In India breast feeding in rural areas appears to be shaped by the health beliefs of a community, which are further influenced by social, cultural and economic factors. One of such tradition is prelacteal feeding which is widely prevalent since ancient times. The present study was aimed to find out the practice of prelacteal feeding and various factors which influence this practice. The study on analysis showed that 45% (90) mothers gave prelacteal feeds to their newborns in the form of sugar water, gur water or cow's milk. Sugar water was common amongst mothers belonging to nuclear family (49%) whereas gur water was given mostly by joint family mothers (75.70%). Parity and family type had no significant effect on this practice, however the effect of literacy was found to be significantly related to the practice.
Objective: To see the usefulness of verbal autopsy and in assessing the cause of deaths among inf... more Objective: To see the usefulness of verbal autopsy and in assessing the cause of deaths among infants and identify gaps in reporting system in 4 PHCs in India. Methodology: The study incorporated all the infant deaths, which occurred in a one-year period from 2 nd Jan 2004 to 1 st Jan 2005 in Yavatmal district in Maharashtra. This data was compared with the corresponding district data and the gaps in reporting were identified site-wise. Results: Medical certification of cause of death was done in only 12% of deaths. Under reporting was more than 50% in 2 PHCs and the IMR was found to be 59 per 1000 live births in contrast to 38 per 1000, given by the district authorities. Prematurity and LBW contributed for the 47% deaths during the early neonatal period. In post neonatal period mostly infectious causes like ARI contributed for 35% followed by CNS infections (12%). Majority (73%) of the 90 infant deaths were delivered at home and were attended by unskilled personnel (72%). Overall there were 63% deaths which occurred in the early neonatal period, 13% in late neonatal period and 23% in post neonatal period. Conclusions: Verbal autopsy can be used to give information for the health planners to prioritize health services based on the mortality pattern of an area and for collecting information for action at the local level.
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Papers by BS Garg