Introduction of case-based learning aided by WhatsApp messenger in pathology teaching for medical students.

Aims: The present study was carried out for comparative evaluation of case-based learning (CBL) aided with WhatsApp and didactic lectures (DL) while teaching a pathology topic to second-year medical students. In addition, the acceptability of WhatsApp as an aid to CBL was assessed. Material and Methods: After obtaining informed consent, 70 second-year Bachelor of Medicine and Bachelor of Surgery (MBBS) students were exposed to six sessions of CBL aided by case scenarios for one set of topics of anemia posted on WhatsApp groups. This was followed by six sessions of DL for separate set of topics in anemia. The multiple-choice questions (MCQ) test scores obtained pre and postintervention, of CBL and DL sessions, were compared to paired t-test (within the groups) and Student's t-test (between the groups). Categorical data were analyzed using Chi-square (χ2) test. Student's self-administered questionnaires and focus group discussions (FGDs) were used to collect student perceptions and analyzed quantitatively, as well as qualitatively. Results: The mean MCQ scores obtained postintervention in CBL topics were significantly higher compared to DL (22.78 ± 2.99 vs 17.78 ± 3.35; P < 0.001). Students perceived that CBL enhanced their curiosity; hence, the acquired knowledge through various resources was retained better. It enhanced their analytical skills and interest in learning pathology. In FGDs, the students appreciated the use of WhatsApp as an aid to CBL for its ease of sharing scenario-related additional information and prior discussions among themselves in chat groups at their convenience. Conclusion: CBL aided by WhatsApp helped students acquire knowledge, discuss and learn actively, score more, and retain better than DL. Using WhatsApp as a platform helped them to interact at their ease and seek guidance from their mentors without resistance and hesitation.

Effect of oropharyngeal colostrum therapy in the prevention of necrotising enterocolitis among very low birthweight neonates: A meta-analysis of randomised controlled trials.

BACKGROUND: Necrotising enterocolitis (NEC) is one of the most common life-threatening emergencies of the gastrointestinal tract in preterm neonates. The present study aimed to determine the efficacy of oropharyngeal colostrum with respect to reducing NEC in preterm neonates. METHODS: A literature search was conducted for various randomised control trials by searching the Cochrane Central Register of Controlled Trials, PubMed, EMBASE and ongoing clinical trials. Randomised or quasi-randomised trials comparing oropharyngeal colostrum versus placebo in neonates (birthweight ≤ 1500 g or gestational age ≤ 32 weeks) were included in the review. The methodological quality of each trial was independently reviewed by the authors. For categorical and continuous variables, typical estimates for relative risk and typical estimates for weighted mean difference were calculated, respectively. A random effect model was assumed for meta-analysis. RESULTS: In total, four eligible trials were included in the review. Oropharyngeal colostrum therapy was not associated with a statistically significant reduction in the incidence of NEC stage ≥2 [typical relative risk (RR) = 0.64; 95% confidence interval (CI) = 0.27-1.49], mortality from any cause (typical RR = 0.86; 95% CI = 0.15-4.80) and time to reach full feed [typical weighted mean difference (WMD) = -3.26; 95% CI = -8.87 to 2.35]. Duration of hospital stay was significantly less in the control group (typical WMD = 9.77; 95% CI = 3.96-15.59). CONCLUSIONS: The current evidence is insufficient for recommending oropharyngeal colostrum as a routine clinical practice in the prevention of NEC. We emphasise the need for large randomised controlled trials with an adequate sample size and validated clinical outcomes in preterm neonates.

Evaluation of biliary complications on magnetic resonance cholangiopancreatography and comparison with direct cholangiography after living-donor liver transplantation.

AIM: To evaluate the imaging characteristics of biliary complications following liver transplantation on magnetic resonance cholangiopancreatography (MRCP) and its diagnostic accuracy in comparison with direct cholangiography. MATERIAL AND METHODS: In this prospective study, 34 patients being evaluated for possible biliary complications after living-donor liver transplantation (LDLT) with abnormal MRCP findings were followed up for information regarding direct cholangiography either endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) within 7 days of MRCP. Twenty-nine patients underwent ERCP and five patients underwent PTC. RESULTS: Compared to findings at direct cholangiography, MRCP presented 96.9% sensitivity, 96.9% positive predictive value, and 94.1% accuracy for the detection of biliary complications. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy for detection of anastomotic strictures, biliary leak, and biliary stone or sludge on MRCP was found to be 100%, 84.6%, 91.3%, 100% and 94.1%; 72.7%, 95.7%, 88.9%, 88% and 88.2%; 80%, 100%, 100%, 96.7% and 97.1%, respectively. CONCLUSION: MRCP is a reliable non-invasive technique to evaluate the biliary complications following LDLT. MRCP should be the imaging method of choice for diagnosis in this setting and direct cholangiography should be reserved for cases that need therapeutic interventions.

Efficacy and tolerability of treatment with single doses of diethylcarbamazine (DEC) and DEC plus albendazole (ABZ) for three consecutive years in lymphatic filariasis: a field study in India.

Lymphatic filariasis (LF) affects 73 countries, causes morbidity and impedes socioeconomic development. We had found no difference in safety and micro (Mf) and macro filarial action of single-dose diethylcarbamazine (DEC) and DEC + albendazole (ABZ) in an F01 study done in India (year 2000). There was a programmatic need to evaluate safety and efficacy of multiple annual treatments (F02). Subjects (155) from the F01 study, meeting inclusion-exclusion criteria, were enrolled in F02 and treated with further two annual doses of DEC or DEC + ABZ. Efficacy was evaluated for Mf positivity by peripheral smear (PS) and nucleopore (NP) filter, circulating filarial antigen (CFA) and filarial dance sign (FDS) positivity and Mf count at yearly follow-up. Safety was assessed for 5 days after drug administration. Total of 139 subjects evaluated for efficacy (69 DEC and 70 DEC + ABZ group). Mf positivity prevalence declined progressively by 95% (PS), 66% (NP), and 95% (PS) and 86% (NP); CFA positivity prevalence declined by 15% and 9%; FDS by 100% each; Mf count declined by 75.5 and 76.9% with three annual treatment of DEC and DEC + ABZ, respectively. Addition of ABZ did not show any advantage over DEC given as three annual rounds for LF. DEC and DEC + ABZ were well tolerated. There was no correlation between result of CFA and FDS, (both claimed to be indicative of adult worm). Analysis of published studies and our data indicate that macrofilaricidal effect of DEC/DEC + ABZ may be seen in children and not adults, with three or more annual dosing.

Perceptions of nonsurgical permanent contraception among potential users, providers, and influencers in Wardha district and New Delhi, India: Exploratory research.

BACKGROUND: New permanent contraceptive methods are in development, including nonsurgical permanent contraception (NSPC). OBJECTIVE: In the present study, perceptions of NSPC in India among married women, married men, mothers-in-law, providers, and health advocates in Eastern Maharashtra (Wardha district) and New Delhi were examined. METHODS: We conducted semi-structured interviews with 40 married women and 20 mothers-in-law; surveys with 150 married men; and focus group discussions with obstetrics/gynecology providers and advocates. Transcripts were coded and analyzed using a grounded theory approach, where emerging themes are analyzed during the data collection period. RESULTS: The majority of female respondents expressed support of permanent contraception and interest in NSPC, stating the importance of avoiding surgery and minimizing recovery time. They expressed concerns about safety and efficacy; many felt that a confirmation test would be necessary regardless of the failure rate. Most male respondents were supportive of female permanent contraception (PC) and preferred NSPC to a surgical method, as long as it was safe and effective. Providers were interested in NSPC yet had specific concerns about safety, efficacy, cost, uptake, and government pressure. They also had concerns that a nonsurgical approach could undermine the inherent seriousness of choosing PC. Advocates were interested in NSPC but had concerns about safety and potential misuse in the Indian context. CONCLUSION: Although perceptions of NSPC were varied, all study populations indicated interest in NSPC. Concerns about safety, efficacy, appropriate patient counseling, and ethics emerged from the present study and should be considered as NSPC methods continue to be developed.

Dual c-Jun N-terminal kinase-cyclin D1 and extracellular signal-related kinase-c-Jun disjunction in human melanoma.

BACKGROUND: Activity of both c-Jun and cyclin D1 is deemed critical for melanoma cell proliferation. This functionality is corroborated by frequently elevated expression and activity of these proteins in human melanomas. Correspondingly, alleviating c-Jun and cyclin D1 function is vital to the success of antimelanoma therapeutics. OBJECTIVES: To understand the role of the c-Jun N-terminal kinase (JNK) signalling pathway in melanoma cell proliferation and survival. METHODS: The effect of JNK inhibitors SP600125 and JNK-IN-8 on the proliferation and survival of genetically highly representative human melanoma cell lines was studied in assays of proliferation and apoptosis. Changes in c-Jun and cyclin D1 protein and mRNA levels in response to JNK and mitogen-activated protein kinase kinase (MEK) inhibition were investigated through immunoblotting and quantitative reverse-transcription polymerase chain reaction. The effects of JNK and MEK inhibitors on cell-cycle distribution were assessed by flow cytometry. RESULTS: We demonstrate the requirement of JNK signalling in melanoma cell proliferation and survival. While JNK inhibition suppressed the expression and activity of c-Jun, it failed to suppress cyclin D1 levels. Consistently with its inability to downregulate cyclin D1, JNK inhibition failed to induce G1 arrest. In contrast, the blockade of MEK-extracellular signal-regulated kinase (ERK) signalling, although unable to suppress c-Jun activity and expression, paradoxically abated cyclin D1 levels and triggered G1 arrest. This previously unreported dual disconnect between JNK-cyclin D1 and ERK-c-Jun levels was confirmed by concomitant JNK and BRAF inhibition, which suppressed both c-Jun and cyclin D1 levels and exhibited a heightened antiproliferative response. CONCLUSIONS: Dual disjunction between JNK-cyclin D1 and ERK-c-Jun signalling forms the basis for further investigation of combined JNK and MAPK signalling blockade as a more effective therapeutic approach in human melanoma.

Seropersistence of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine): 6-month follow-up of a randomized, controlled, observer-blind, phase 2/3 immuno-bridging study in Indian adults.

AZD1222 (ChAdOx1 nCoV-19) is a replication-deficient adenoviral vectored coronavirus disease-19 (COVID-19) vaccine that is manufactured as SII-ChAdOx1 nCoV-19 by the Serum Institute of India Pvt Ltd following technology transfer from Oxford University/AstraZeneca. The non-inferiority of SII-ChAdOx1 nCoV-19 with AZD1222 was previously demonstrated in an observer-blind, phase 2/3 immuno-bridging study (trial registration: CTRI/2020/08/027170). In this analysis of immunogenicity and safety data 6 months post first vaccination (Day 180), 1,601 participants were randomized 3:1 to SII-ChAdOx1 nCoV-19 or AZD1222 (immunogenicity/reactogenicity cohort n = 401) and 3:1 to SII-ChAdOx1 nCoV-19 or placebo (safety cohort n = 1,200). Immunogenicity was measured by anti-severe acute respiratory syndrome coronavirus 2 spike (anti-S) binding immunoglobulin G and neutralizing antibody (nAb) titers. A decline in anti-S titers was observed in both vaccine groups, albeit with a greater decline in SII-ChAdOx1 nCoV-19 vaccinees (geometric mean titer [GMT] ratio [95% confidence interval (CI) of SII-ChAdOx1 nCoV-19 to AZD1222]: 0.60 [0.41-0.87]). Consistent similar decreases in nAb titers were observed between vaccine groups (GMT ratio [95% CI]: 0.88 [0.44-1.73]). No cases of severe COVID-19 were reported following vaccination, while one case was observed in the placebo group. No causally related serious adverse events were reported through 180 days. No thromboembolic or autoimmune adverse events of special interest were reported. Collectively, these data illustrate that SII-ChAdOx1 nCoV-19 maintained a high level of immunogenicity 6 months post-vaccination. SII-ChAdOx1 nCoV-19 was safe and well tolerated.

SCOPE: Surveillance of COVID-19 in pregnancy- results of a multicentric ambispective case-control study on clinical presentation and maternal outcomes in India between April to November 2020.

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 study period. Data of 3723 COVID positive pregnant women and 3744 age-matched controls was analyzed. Of the positive cases 56·9% were asymptomatic. Antenatal complications like preeclampsia and abruptio placentae were seen more among the cases. Induction and caesarean delivery rates were also higher among Covid positive women. Pre-existing maternal co-morbidities increased need for supportive care. There were 34 maternal deaths out of the 3723(0.9%) positive mothers, while covid negative deaths reported from all the centres were 449 of 72,541 (0·6%). CONCLUSION: Covid-19 infection predisposed to adverse maternal outcomes in a large cohort of Covid positive pregnant women as compared to the negative controls.

Nurturing Care Interventions for Realizing the Development Potential of Every Child: From Pilot to Scale Up in Maharashtra.

The WHO-UNICEF nurturing care framework (NCF) for early childhood development provides a roadmap for action, focusing on pregnancy and the first three years of life. It emphasizes the need to invest in capacity building and empowerment of service providers, families and communities to create a conducive environment that promotes child development. We describe our experience of implementing nurturing care interventions, beginning with a pilot project in Maharashtra covering a population of 10000 to and scaling it up to a model called Aarambh (the beginning), catering to a population of 1,500,000. Opportunities available within the existing services across multiple sectors were used; Integrated Child Development Services (ICDS) scheme, the health sector, and others. It utilized multiple approaches for promoting NCF within families; home visits by frontline workers (FLWs), mothers' meetings, growth monitoring and promotion sessions, and community-based events as key opportunities. Joint training for FLWs, establishing supervisors of FLWs as their trainers, and an interactive training curriculum were critical elements identified for the success of the model. An environment of appreciation for the FLWs and their supervisors helped build their confidence and helped them own the interventions.

A phase 2/3, participant-blind, observer-blind, randomised, controlled study to assess the safety and immunogenicity of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine) in adults in India.

BACKGROUND: This phase 2/3 immunobridging study evaluated the safety and immunogenicity of the ChAdOx1 nCoV-19 Coronavirus Vaccine (Recombinant) (SII-ChAdOx1 nCoV-19), manufactured in India at the Serum Institute of India Pvt Ltd (SIIPL), following technology transfer from the AstraZeneca. METHODS: This participant-blind, observer-blind study randomised participants 3:1 to SII-ChAdOx1 nCoV-19 or AZD1222 (ChAdOx1 nCoV-19) (immunogenicity/reactogenicity cohort) and 3:1 to SII-ChAdOx1 nCoV-19 or placebo (safety cohort). The study participants were enrolled from 14 hospitals across India between August 25 and October 31, 2020. Two doses of study products were given 4 weeks apart. The primary objectives were to demonstrate non-inferiority of SII-ChAdOx1 nCoV-19 to AZD1222 in terms of geometric mean titre (GMT) ratio of anti-SARS-CoV-2 spike IgG antibodies 28 days after the second dose (defined as lower limit of 95% CI >0·67) and to determine the incidence of serious adverse events (SAEs) causally related to SII-ChAdOx1 nCoV-19. The anti-spike IgG response was assessed using a multiplexed electrochemiluminescence-based immunoassay. Safety follow-up continued until 6 months after first dose. Trial registration: CTRI/2020/08/027170. FINDINGS: 1601 participants were enrolled: 401 to the immunogenicity/reactogenicity cohort and 1200 to the safety cohort. After two doses, seroconversion rates for anti-spike IgG antibodies were more than 98·0% in both the groups. SII-ChAdOx1 nCoV-19 was non-inferior to AZD1222 (GMT ratio 0·98; 95% CI 0·78-1·23). SAEs were reported in ≤ 2·0% participants across the three groups; none were causally related. A total of 34 SARS-CoV-2 infections were reported; of which 6 occurred more than 2 weeks after the second dose; none were severe. INTERPRETATION: SII-ChAdOx1 nCoV-19 has a non-inferior immune response compared to AZD1222 and an acceptable safety/reactogenicity profile. Pharmacovigilance should be maintained to detect any safety signals. FUNDING: SIIPL funded the contract research organisation and laboratory costs, while the site costs were funded by the Indian Council of Medical Research. The study vaccines were supplied by SIIPL and AstraZeneca.

An evaluation of ROME Camp: forgotten innovation in medical education.

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 (ROME) camp for final year medical undergraduates at one of the rural centres of the department of Community Medicine. The objectives of the present study were to learn students' perceptions of the value and effectiveness of various components of the ROME camp and learn the factors they perceive facilitate and inhibit learning. METHODS: A mixed-method research design of quantitative (survey) and qualitative (force field analysis) methods was used. The study participants were all 61 of the final year medical undergraduates participating in the ROME camp in 2008. The quantitative data was analyzed using SPSS software package and summative content analysis of the qualitative data was undertaken. RESULTS: Students were generally very positive about all aspects of the camp and its component parts. The greatest consensus (88.9%, on a 0 to 100% scale) was for the contribution to student learning of the visit to the Primary health centre and Sub-centre, as offering direct exposure and interaction with the village-level service providers. There was poorer consensus for students' involvement with the field-based clinics, as this was felt by some not to contribute significantly to their understanding of socio-economic and environmental factors related to cases (78.8%) and their ability to diagnose health problems in resource poor settings (76.5%). The major strength of the camp was felt to be its exposure visits and hands-on experiences in surveys and interaction with village-level health care providers. Students reported poor interactions with teachers in some educational sessions, including the field-based clinics and classes on theories of national health programs. CONCLUSIONS: The curriculum of the ROME camp was generally well regarded by students, but based on their views it should emphasize interactive theory sessions. The ROME scheme can be revitalized in all medical colleges as it is an effective practical approach for teaching public health principles and practice to medical students.

Intestinal parasites prevalence and related factors among school children in the rural area of central India.

A cross sectional study was conducted to determine the prevalence of intestinal parasitic infections and its epidemiological correlates among rural Indian school going children and to find out the effect of hygiene education on personal hygiene of school children at village Karanji (Kaji) in Wardha district of central India. Out of 172, 87 (50.6%) boys and 85 (49.4%) girls were examined. The mean age of the school children was 10.37 +/- 2.71. The prevalence of intestinal parasite infection was 7.56%. The prevalence was significantly high among barefoot children (OR = 8.99; 95% CI: 2.14 - 43.49) followed by those having poor hand washing practices (OR = 4.90; 95% CI: 1.30 - 20.01), not using sanitary latrine (OR = 2.49; 95% CI: 0.6 - 11.91)) and dirty untrimmed nails (OR = 1.98; 95% CI: 0.56 - 7.04). One month after hygiene education, there was significant improvement in the key personal hygiene behavior (p < 0.05). The proportion of children having practice of hand washing with soap after defecation significantly improved. Health education on personal hygiene to the school children was effective for behavior change. A multisectoral control approach and hygiene education will help health authorities in strategy of control programs for intestinal parasites among school going children.

Symphytum officinale augments osteogenesis in human bone marrow-derived mesenchymal stem cells in vitro as they differentiate into osteoblasts.

ETHNOPHARMACOLOGICAL RELEVANCE: Mesenchymal stem cells (MSCs) are multipotent stem cells possessing regenerative potential. Symphytum officinale (SO) is a medicinal plant and in homoeopathic literature, believed to accelerate bone healing. AIM OF THE STUDY: This study aimed to determine if homoeopathic doses of SO could augment osteogenesis in MSCs as they differentiate into osteoblasts in vitro. MATERIALS AND METHODS: Bone marrow samples were obtained from patients who underwent bone grafting procedures (n = 15). MSCs were isolated, expanded and characterized by flow cytometry (CD90, CD105). Cytotoxicity of SO was evaluated by MTT assay. Osteogenic differentiation was induced in MSCs with ß-glycerophosphate, ascorbic acid and dexamethasone over 2 weeks. Different homoeopathic doses of SO (MT, 3C, 6C, 12C and 30C) were added to the basic differentiation medium (BDM) and efficiency of MSCs differentiating into osteoblasts were measured by evaluating expression of Osteocalcin using flow cytometry, and alkaline phosphatase activity using ELISA. Gene expression analyses for osteoblast markers (Runx-2, Osteopontin and Osteocalcin) were evaluated in differentiated osteoblasts using qPCR. RESULTS: Flow cytometry (CD90, CD105) detected MSCs isolated from bone marrow (93-98%). MTT assay showed that the selected doses of SO did not induce any cytotoxicity in MSCs (24 hours). The efficiency of osteogenic differentiation (2 weeks) for different doses of Symphytum officinale was determined by flow cytometry (n = 10) for osteoblast marker, Osteocalcin, and most doses of Symphytum officinale enhanced osteogenesis. Interestingly, gene expression analysis for Runx-2 (n = 10), Osteopontin (n = 10), Osteocalcin (n = 10) and alkaline phosphatase activity (n = 8) also showed increased osteogenesis with the addition of Symphytum officinale to BDM, specially mother tincture. CONCLUSIONS: Our findings suggest that homoeopathic dose (specially mother tincture) of Symphytum officinale has the potential to enhance osteogenesis.

Serum elastase inhibitor deficiency and alpha 1-antitrypsin deficiency in patients with obstructive emphysema.

A decreased inhibition of pancreatic elastase has been detected in the serums of six patients with alpha(1)-antitrypsin deficiency. Five have severe clinical and physiological pulmonary emphysema. This observation extends the defect of inhibition by serum to a second, biologically active proteolytic enzyme in this form of familial emphysema.

Validating the MUAC (Mid-upper arm circumference) Cut-off for Detection of Severe Acute Malnutrition in Children Aged 6-59 Months in Rural Maharashtra.

OBJECTIVE: To review the Mid-upper arm circumference (MUAC) cut-off currently being used to identify Severe Acute Malnutrition (SAM) as currently defined using Weight-for-Height. METHODS: Cross-sectional study conducted in 24 villages of a Primary Health Centre in Wardha district of Maharashtra among 2650 children between the ages of 6 to 59 months. RESULTS: For identifying SAM, sensitivity of MUAC was 23.5% and specificity was 99.7% for cut-off <11.5 cm. Using Youden index, best Mid-upper arm circumference cut-off point to identify SAM was <13 cm with sensitivity of 74.5% and specificity of 92.7%. Using Receiver operating characteristics curve, best MUAC cut-off point was 12.8 cm with 74.5% sensitivity and 92.7% specificity. Area under curve was 0.88 (95%CI: 0.85-0.91). CONCLUSION: The current MUAC cut-off of <11.5 cm for detecting SAM needs to be increased to ensure that children, who need referral for management of malnutrition, are not missed.

Immunogenicity and lot-to-lot consistency of a ready to use liquid bovine-human reassortant pentavalent rotavirus vaccine (ROTASIIL - Liquid) in Indian infants.

BACKGROUND: A lyophilized bovine-human rotavirus reassortant pentavalent vaccine (BRV-PV, Rotasiil®) was licensed in 2016. A liquid formulation of this vaccine (LBRV-PV, Rotasiil - Liquid) was subsequently developed and was tested for non-inferiority to Rotasiil® and for lot-to-lot consistency. METHODS: This Phase II/III, open label, randomized study was conducted at seven sites across India from November 2017 to June 2018. Participants were randomized into four arms; Lots A, B, and C of LBRV-PV and Rotasiil® in 1:1:1:1 ratio. Three doses of study vaccines were given at 6, 10, and 14 weeks of age. Blood samples were collected four weeks after the third dose to assess rotavirus IgA antibody levels. Non-inferiority of LBRV-PV to Rotasiil was proven if the lower limit two-sided 95% confidence interval (CI) of geometric mean concentration (GMC) ratio was at least 0.5. Lot-to-lot consistency was proven if 95% CI of the GMC ratios of three lots were between 0.5 and 2. Solicited reactions were collected by using diary cards. RESULTS: Of the 1500 randomized infants, 1436 infants completed the study. The IgA GMC ratio of LBRV-PV to Rotasiil® was 1.19 (95% CI 0.96, 1.48). The corresponding IgA seropositivity rates were 60.41% (57.41, 63.35) and 52.75% (47.48, 57.97). The IgA GMC ratios among the three LBRV-PV lots were: Lot A versus Lot B: 1.34 (1.03, 1.75); Lot A versus Lot C: 1.22 (0.93, 1.60); and Lot B versus Lot C: 0.91 (0.69, 1.19). The 95% CIs for the GMC ratios were between 0.69 and 1.75. The incidence of solicited reactions was comparable across the four arms. Only one serious adverse event of gastroenteritis event in the Rotasiil® group was causally related. CONCLUSION: The immunological non-inferiority of LBRV-PV against Rotasiil® as well as lot-to-lot consistency of LBRV-PV was demonstrated. LBRV-PV had safety profile similar to Rotasiil®. TRIAL REGISTRATION NUMBER: Clinical Trials.Gov [NCT03474055] and Clinical Trial Registry of India [CTRI/2017/10/010104].

Evaluation of WHO haemoglobin colour scale & palmar pallor for screening of anaemia among children (6-35 months) in rural Wardha, India.

BACKGROUND & OBJECTIVE: Anaemia is a public health problem in India, particularly in women and children. Clinical diagnosis by health workers may be inaccurate. It is therefore important to evaluate simple methods for diagnosis of anaemia in rural set up with no or minimal laboratory facilities. We carried out this study to evaluate the performance of haemoglobin colour scale and palmar pallor against filter paper cyanmethaemoglobin method as screening methods for anaemia in children 6-35 months of age. METHODS: A total of 772 children between 6-35 months were studied from three primary health centres of Wardha district, central India, by house-to-house visit. The child was examined for presence of palmar pallor and haemoglobin estimated by haemoglobin colour scale (HCS) and filter paper cyanmethaemoglobin method independently by two persons. RESULTS: Haemoglobin colour scale had sensitivity of 89 per cent and specificity of 97 per cent in detecting anaemia in children. Pallor had sensitivity of 73 per cent and specificity of 98 per cent. The predictive values were 99 per cent and 69 per cent for positive and negative HCS result. Similarly, the predictive values were 99 and 48 per cent for positive and negative pallor result. Correct diagnosis of anaemia was 34 and 0.1 times common if HCS test result was positive (Hb < 110.0 g/l) and negative (Hb > 110.0 g/l) for anaemia. INTERPRETATION & CONCLUSION: HCS fulfills the requirement of field test for screening of anaemia in resource poor country. It also has acceptable precision and accuracy and hence can be used in national anaemia control programmes.

Correlates of overweight & obesity among school going children of Wardha city, Central India.

BACKGROUND & OBJECTIVE: Overweight and obesity are important determinants of health leading to adverse metabolic changes and increase the risk of non communicable diseases. Following the increase in adult obesity, the proportion of overweight and obese children and adolescents has also been increasing. Hence, the present study was undertaken to study the magnitude of overweight/obesity and its correlates among school going children of Wardha city in central India and suggest interventions. METHODS: The cross-sectional study was carried out in all the 31 middle-schools (5th to 7th standard) and high-schools (8th to 10th standard) of Wardha city. Probability proportionate to size of population technique (PPS) was used to decide the number of children to be studied from each school, each class and then each section. Systematic random sampling technique was used to select the children from each section. Pre-designed and pre-tested questionnaire was used to elicit the information on family characteristics and individual characteristics. Height and weight was measured and BMI was calculated. Overweight and obesity was assessed by BMI for age. Student who had BMI for age >or=85th and < 95th percentile of reference population were classified as overweight and BMI for age >or=95th percentile of reference population were classified as obese. RESULTS: Overweight and obesity was found to be 3.1 per cent (95% CI: 2.5-3.8%) and 1.2 per cent (95% CI: 0.8-1.8%) respectively; together constitute 4.3 per cent (95% CI: 3.6-5.2%) for overweight/ obesity. Final model of the multivariate logistic regression showed that the important correlates of overweight/obesity were urban residence, father and/or mother involved in service/business, English medium school and child playing outdoor games for less than 30 min. INTERPRETATION & CONCLUSION: The magnitude of overweight/obesity among school going children of Wardha city was found to be 4.3 per cent. Family characteristics play important role in predisposing the children to overweight/obesity and hence the interventions need to be directed towards the families.

Effectiveness of weekly supplementation of iron to control anaemia among adolescent girls of Nashik, Maharashtra, India.

A national nutritional anaemia-control programme in India, focusing on supplementation of iron to pregnant women after the first trimester of pregnancy, failed to make an impact. It is prudent to recommend the correction of iron stores before the woman becomes pregnant. 'Efficacy' of weekly supplementation of iron has been proved to improve iron stores in adolescence in many studies abroad and in India. The objective was to study the 'effectiveness' of a weekly iron-supplementation regimen among urban-slum, rural, and tribal girls of Nashik district, Maharashtra, India. A baseline and the mid-term assessments were done using the cluster-sampling techniques. In each stratum, 30 clusters were identified. Twelve and 10 adolescent girls from each cluster were identified in the baseline and mid-term surveys respectively. The haemoglobin estimation was done using the HemoCue system. Data were analyzed using the Epi Info software (version 6.04). The overall prevalence of anaemia came down significantly to 54.3% from 65.3%. The decline was statistically significant (p<0.001) in tribal girls (48.6% from 68.9%) and among rural girls (51.6% from 62.8%). But the decline was not statistically significant among urban slum girls. Similarly, a significant rise in the mean haemoglobin levels was seen among tribal and rural girls. However, it did not increase significantly among urban slum girls. The programme had performed poorly in urban-slum areas, as the mean number of tablets consumed in urban-slum areas was only 5.6+/-3.3, as against 6.7+/-2.6 tablets in tribal girls and 7.2+/-2.2 tablets in rural girls. Considering the biological and operational feasibility and the effectiveness of the intervention, weekly supplementation of iron to adolescent girls should be universally started to correct the iron stores of a woman before she becomes pregnant.