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To estimate the disease and economic burden of pertussis amongst hospitalised infants in India. Multicentric hospital-based surveillance study. Hospitalised infants with clinical suspicion of pertussis based on predefined criteria. Proportion of infants with laboratory-confirmed pertussis, economic burden of pertussis amongst hospitalised infants. 693 clinically suspected infants were recruited of which 32 (4.62%) infants had laboratory-confirmed pertussis. Progressive cough with post-tussive emesis (50%) and pneumonia (34%) were the common clinical presentations; apnea in young infants was significantly associated with pertussis. Infants with pertussis were more likely to be younger (median age 102.5 days vs. 157 days) and born preterm (42.9% vs 24.5%). Almost 30% infants with pertussis had not received vaccine for pertussis with 50% of these infants aged less than 2 months. Pertussis was associated with higher costs of hospitalisation, pharmacy and loss of working days by caregivers as compared to non-pertussis cases. Younger infants, those born preterm and those inadequately immunised against pertussis are at higher risk of pertussis infection. Timely childhood immunisation and introduction of maternal immunisation for pertussis can help in reducing the disease burden.

Currently, a major curricular reform in the form of competency-based medical education (CBME) curriculum is being rolled out across all medical colleges in India. However, it is important to find out and address the concerns of faculty regarding various aspects of this new curriculum.To analyze the concerns of the faculty members of medical colleges in India in response to the changes emerging from the adoption and implementation of the new curriculum through the concerns-based adoption model by applying the stages of concern (SoC) questionnaire.A multicentric, cross-sectional quantitative study involving faculty members currently working in medical colleges and with more than 2 years of teaching experience was conducted using SoC questionnaire (SoCQ). The questionnaire was delivered as Google Form.Of the 744 faculty participants, 41.1% (306) of faculty belonged to the 31-40 years age group followed by the 41-50 years age group (267, 35.9%). Respondents rated their level of concern differently among the seven SoC - percentile scores were highest in Stage 0- awareness (94) and least in Stage 4- consequences (59). An appreciably higher percentile scores were seen at the consequences stage (63 vs. 54), collaboration stage (80 vs. 68), and refocusing stage (77 vs. 69) in those faculty members who were trained in curriculum implementation support program (CISP) compared to the untrained group. However; the SoCQ profiles of CISP trained and untrained faculty were very much similar. SoCQ profiles of holders of advanced training in medical education and non-holders were also the same.Almost after 2 years of well-planned introduction of the CBME curriculum in India, the generalized faculty profile is still suggestive of interested but non-user type for the adoption of CBME. However; compared to untrained faculty, CISP trained faculty is more concerned about the impact of CBME on students, collaborating with colleagues for its proper implementation and exploring more benefits from the implementation of CBME, indicating that more hand-holding is required for faculty development beyond CISP.

Background Vaccination is considered as the most cost effective method for preventing infectious diseases. Low grade fever is a known adverse effect of vaccination. In India, it is a common clinical practice to prescribe paracetamol either prophylactically or therapeutically to manage fever. Some studies have shown that paracetamol interferes with antibody responses following immunization. This manuscript reports the outcome of a post hoc analysis of data from a clinical trial of a pentavalent vaccine in Indian infants where paracetamol was not used or was used either as prophylaxis or for treatment of fever. Methods Pre and post vaccine antibody levels against Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus influenzae type B were assessed in no paracetamol and paracetamol groups. The paracetamol group was further divided into prophylactic and treatment groups. Results Similar rates of seroprotection/seroresponse for anti-D, anti-T, anti-wP, anti-PT, anti-HBs and anti-PRP were observed in all the groups. There was no clear tendency for difference in percentage seroprotection/seroresponse and geometric mean (GM) titers in any of the groups. Conclusion The study found no evidence that paracetamol usage either as prophylactic or for treatment impact immunological responses to DTwP-HepB-Hib combination vaccine. [Clinical trial registry of India (study registration number CTRI/2012/08/002872 )].

To evaluate the immunogenicity and safety of a fully liquid, hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-hepatitis B-Haemophilus influenzae type b (DTaP-IPV- HB-PRP~T) vaccine in Indian infants.Phase III, single-arm study.Two tertiary care hospitals.177 healthy, 6-week-old infants.All participants received hepatitis B vaccine and Oral polio vaccine (OPV) at birth and DTaP-IPV-HB-PRP~T at 6, 10, 14 weeks of age.Serum was analyzed for immune responses to all antigens 1 month post- 3rd dose; safety was assessed for 30 minutes post-vaccination, and for 7 days (solicited reactions) and 30 days (unsolicited events).Seroprotection rates were 100% for anti-HB (10 mIU/mL), anti-PRP (0.15 ug/mL), anti-T (0.01 IU/mL), anti-polio 1, 2, and 3 (8 [1/dil]), and 99.3% for diphtheria (0.01 IU/mL). For the pertussis antigens, vaccine response rate was 93.8% for anti-PT and 99.3% for anti-FHA. 37.9% and 54.6% of participants experienced at least one solicited injection site and systemic reaction, respectively, and 20.3% of participants experienced at least one unsolicited event (none of which was related to the vaccination). Four serious adverse events (including one death) were reported, but none was related to the vaccination.The fully liquid DTaP-IPV-HB-PRP~T vaccine is highly immunogenic in infants in India when administered in a 6, 10, 14 week schedule along with HB and OPV administered at birth, and was well tolerated.

Objective We aim to describe the data collected from India during phase 3 of the International study of asthma and allergy in childhood (ISAAC) study. Prevalence, severity, and population characteristics associated with rhinitis, rhinoconjunctivitis, and eczema were assessed. Methods Children from two age groups (6-7 and 13-14 years) were included in the study as per the ISAAC protocol. The symptoms of allergy and associated features were assessed using a questionnaire. Results The prevalence of allergic rhinitis among the 6-7 years age group was 11.3%, while it was 24.4% in the 13-14 years age group. The prevalence of allergic rhinoconjunctivitis was 3.9% in the 6-7 years age group and 10.9% in the 13-14 years age group. The prevalence of eczema was 2.8% in the 6-7 years age group and 3.7% in the 13-14 years age group. The passage of trucks near home, parental smoking, use of paracetamol, use of antibiotics, cooking with firewood, and television watching were associated with allergic rhinitis, rhinoconjunctivitis, and eczema. Maternal smoking was the strongest of all the associated features for allergic rhinitis, rhinoconjunctivitis, and eczema, especially in the 6-7 years age group (odds ratio: 1.9, 95% CI: 1.5-2.4; odds ratio: 2.9, 95% CI, 2.2-3.9; and odds ratio: 3.5, 95% CI: 2.6-4.8, respectively). Conclusion Allergic conditions like allergic rhinitis, rhinoconjunctivitis, and eczema are prevalent among Indian children and are associated with environmental tobacco smoke, paracetamol use, antibiotic use, television watching, and outdoor and indoor air pollution.

Background: Enuresis affects about 15 to 20% of five year old children, and even up to 2% of young adults. The various treatment modalities used are behavioural therapy, alarm intervention and pharmacological therapy. Current evidences suggest that alarm intervention is preferable to other modalities of treatment. So a study was done to assess the efficacy of alarm interventions in primary monosymptomatic nocturnal enuresis in children. Methods: A prospective study was done on children aged between 5-18 years with primary monosymptomatic nocturnal enuresis on a total of 62 children. An enuresis diary was maintained by parents. All children received alarm intervention for 12 weeks. A child remaining dry for two consecutive weeks was taken as a success. The subjects were followed up for 12 weeks, two or more wet night in 2 weeks period were taken as relapse. If child failed to become dry after 12 weeks of alarm intervention, intervention was continued for maximum of 6 months or till he became dry. Results: Out of 62 children, majority were males and in the age group of 5-7 years. Family history of enuresis was present in 30.65% of children. A total of 74.19 % of subjects achieved dryness while failures were 25.8% and relapse was seen in 23.91 % during follow up. Significant improvement was noticed as early as 2 months after alarm intervention (p 0.00499) but maximum improvement was seen after 5 months (20 week). On follow up 23.91 % children had relapsed but the frequency of wet nights among these also was significantly low (mean wet nights 0.08/week). Even among failures there was a significant decrease in mean number of wet nights (from 4.24 wet nights/week to 1.85 wet nights/week). Conclusions: Alarm treatment was an effective intervention for management of primary monosymptomatic nocturnal enuresis with high success and low relapse rate.

Pentavalent combination vaccines are important tools to strengthen the immunization programs in numerous countries throughout the world. A large number of countries have recognized the value of combination vaccines and have introduced whole cell pentavalent vaccines into their immunization programs. A phase III, multi-center, randomized, single blinded study of a fully liquid pentavalent DTwP-HepB-Hib investigational vaccine (Shan5™) was conducted across India in 2 cohorts: 15 toddlers were evaluated for safety and immunogenicity following a single booster dose (Cohort 1) followed by 1085 infants (Cohort 2) evaluated for immunogenicity and safety following 3-dose primary immunization of the investigational vaccine or a locally licensed comparator vaccine (Pentavac SD). Immune consistency analysis among 3 lots of the investigational vaccine, and immune non-inferiority analysis of pooled (3 lots) data of investigational vaccine vs. comparator vaccine were carried out in cohort 2. The vaccines demonstrated comparable safety and immune responses in cohort 1. In cohort 2, equivalent immune consistency among 3 lots was observed for all antigens except whole cell pertussis antigens, where a marginal variation was observed which was linked to the low power of the test and concluded to not have any clinical significance. Immune non-inferiority against the comparator vaccine was demonstrated for all 5 antigens. Safety results were comparable between vaccine groups. This investigational, fully-liquid, whole-cell pertussis (wP) containing new pentavalent vaccine was found to be safe and immunologically non-inferior to the licensed comparator vaccine.

Dengue is a mosquito-borne viral disease that is endemic in India. We evaluated the immunogenicity and safety of recombinant, live-attenuated, tetravalent dengue vaccine (CYD-TDV) in Indian adults. In this observer-blind, randomized, placebo-controlled, Phase II study, adults aged 18-45 years were randomized 2:1 to receive CYD-TDV or placebo at 0, 6 and 12 months in sub-cutaneous administration. Immunogenicity was assessed using a 50% plaque reduction neutralization test (PRNT50) at baseline and 28 days after each study injection. 189 participants were enrolled (CYD-TDV [n = 128]; placebo, [n = 61]). At baseline, seropositivity rates for dengue serotypes 1, 2, 3 and 4 ranged from 77.0% to 86.9%. Seropositivity rates for each serotype increased after each CYD-TDV injection with a more pronounced increase after the first injection. In the CYD-TDV group, geometric mean titres (GMTs) were 2.38 to 6.11-fold higher after the third injection compared with baseline but remained similar to baseline in the placebo group. In the CYD-TDV group, the GMTs were 1.66 to 4.95-fold higher and 9.23 to 24.6-fold higher after the third injection compared with baseline in those who were dengue seropositive and dengue seronegative, respectively. Pain was the most commonly reported solicited injection site reaction after the first injection in both the CYD-TDV (6.3%) and placebo groups (4.9%), but occurred less frequently after subsequent injections. No serious adverse events were vaccine-related, no immediate unsolicited adverse events, and no virologically-confirmed cases of dengue, were reported during the study. The immunogenicity and safety of CYD-TDV was satisfactory in both dengue seropositive and seronegative Indian adults.

In this phase III, open-label, multicenter, and descriptive study in India, children primed with 3 doses (at ages 6, 10, and 14 weeks) of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) were randomized (1:1) to receive a booster dose at 9 to 12 (early booster) or 15 to 18 months old (late booster) in order to evaluate impact of age at booster. We also evaluated a 2-dose catch-up vaccination plus an experimental booster dose in unprimed children age 12 to 18 months. The early booster, late booster, and catch-up vaccinations were administered to 74, 95, and 87 children, respectively; 66, 71, and 81 children, respectively, were included in the immunogenicity according-to-protocol cohort. One month postbooster, for each PHiD-CV serotype, ≥95.2% (early booster) and ≥93.8% (late booster) of the children had antibody concentrations of ≥0.2 μg/ml; ≥96.7% and ≥93.0%, respectively, had opsonophagocytic activity (OPA) titers of ≥8. The postbooster antibody geometric mean concentrations (GMCs) were in similar ranges for early and late boosters; the OPA titers appeared to be lower for most PHiD-CV serotypes (except 6B and 19F) after the early booster. After dose 2 and postbooster, for each PHiD-CV serotype, ≥88.6% and ≥96.3%, respectively, of the catch-up immunogenicity according-to-protocol cohort had antibody concentrations of ≥0.2 μg/ml; ≥71.4% and ≥90.6%, respectively, had OPA titers of ≥8. At least 1 serious adverse event was reported by 2 children in the early booster (skin infection and gastroenteritis) and 1 child in the catch-up group (febrile convulsion and urinary tract infection); all were resolved, and none were considered by the investigators to be vaccine related. PHiD-CV induced robust immune responses regardless of age at booster. Booster vaccination following 2 catch-up doses induced robust immune responses indicative of effective priming and immunological memory. (These studies have been registered at www.clinicaltrials.gov under registration no. NCT01030822 and NCT00814710; a protocol summary is available at www.gsk-clinicalstudyregister.com [study ID 112909]).

Good communication skills are essential for an optimal doctor-patient relationship, and also contribute to improved health outcomes. Although the need for training in communication skills is stated as a requirement in the 1997 Graduate Medical Education Regulations of the Medical Council of India, formal training in these skills has been fragmentary and non-uniform in most Indian curricula. The Vision 2015 document of the Medical Council of India reaffirms the need to include training in communication skills in the MBBS curriculum. Training in communication skills needs approaches which are different from that of teaching other clinical subjects. It is also a challenge to ensure that students not only imbibe the nuances of communication and interpersonal skills, but adhere to them throughout their careers. This article addresses the possible ways of standardizing teaching and assessment of communication skills and integrating them into the existing curriculum.

In India, pneumococcal diseases are major causes of child mortality, and effective vaccines against Streptococcus pneumoniae are needed. This single-blind, randomized study assessed the immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Hemophilus influenzae (NTHi) protein D conjugate vaccine (PHiD-CV) co-administered with DTPw-HBV/Hib in Indian infants as 3-dose primary vaccination course. A total of 360 infants were randomized (2:1) to receive either PHiD-CV co-administered with DTPw-HBV/Hib (PHiD-CV group) or a Hib vaccine co-administered with DTPw-HBV (control group) at 6, 10, and 14 weeks of age. For each vaccine pneumococcal serotype, the percentage of infants in the PHiD-CV group with antibody concentrations ≥ 0.2 µg/mL one month after the third vaccine dose was at least 98.3%, except for serotypes 6B (77.7%) and 23F (89.5%), and opsonophagocytic activity titers ≥ 8 were measured in at least 95.7% of infants, except for serotypes 1 (90.5%) and 6B (84.5%). In addition, all the infants in the PHiD-CV group were seroprotected against diphtheria, tetanus, Hib, and hepatitis B or seropositive for antibodies against pertussis and NTHi protein D (except one infant). Incidences of solicited local and general symptoms were comparable between groups, except for fever (axillary temperature ≥ 37.5°C), which seemed to occur more frequently in the PHiD-CV group. In conclusion, PHiD-CV was shown to be immunogenic and well-tolerated when co-administered with DTPw-HBV/Hib in Indian infants.

Background and aims : Growth in children with mental retardation differs from that of normal children, but majority of studies have been performed in western countries and have focused on the early years of life. The purpose of this study therefore was to evaluate the growth pattern of male mentally retarded adolescents from North India and compare it with that of normal male children. Materials and methods : Two hundred institutionalized intellectually disabled (I.Q. less than 70) and two hundred normal male children between 10-20 years of age from North India were selected and the physical growth parameters i.e. height and weight were measured and Body Mass Index (BMI) was calculated in all subjects. The mentally retarded and normal groups of boys were categorized separately on the basis of their age into one-year age groups. The data was then compared between the two groups using 2 sample't' test. Results : The results indicated that the mean height and weight of mentally retarded boys during adolescence was significantly retarded as compared to normal subjects. However, the intellectually disabled and the normal group do not show any significant difference in their body fat during adolescence. The mean height and weight gain of mentally retarded children during adolescence (11-20 years) however did not vary from that of normal children. Conclusions : Thus, the physical growth retardation in children with intellectual disabilities occurs during early childhood i.e. before 11 years of age.

There are very few reports from the developing world on the prevalence of obesity among children even though in developed countries it has reached epidemic proportions. The objective of this study was to determine the prevalence of obesity in pre-adolescent and adolescent children in a developing country (India) using WHO guidelines for defining obesity and overweight. This cross-sectional study was carried out on 2008 school-children aged 9-15 years. Approximately half the subjects belonged to a school attended by children of well to do families while the rest belonged to two schools from middle and lower socio-economic background. Weight and height were taken for all children and the body mass index (BMI) calculated. Children whose BMI was85th percentile for age and sex were defined as overweight. Triceps skin fold thickness (TSFT) was measured for all overweight children and those with TSFT90th percentile for age and sex were defined as obese. The overall prevalence of obesity and overweight was 11.1% and 14.2% respectively. The prevalence of obesity as well as overweight was higher in boys as compared to girls (12.4% vs 9.9%, 15.7% vs 12.9%). Prevalence of obesity decreased significantly with age, from 18.5% at 9 years to 7.6% at 14 years, rising at 15 years to 12.1%. Significantly more children from higher socio-economic status were obese and overweight than those from lower socio-economic status groups. No significant gender difference for obesity prevalence was seen among children from a less privileged background, however, amongst children from affluent families, significantly more boys were obese as compared to girls. Pediatric obesity is an emerging problem in developing countries, especially among higher socio-economic status groups. Significant gender disparity is seen, with boys of affluent background having a higher prevalence.

Background: Growth of mentally retarded children differs from that of normal children. However, the adolescent growth and development of Indian mentally retarded children has not been studied. Aim: This study was conducted to evaluate the physical growth and sexual development of adolescent mentally retarded girls in North Indian population and to compare it with that of normal girls of same age group. Materials and Methods: One hundred mentally retarded (intelligence quotient (IQ) less than 70) and 100 normal girls between 10 and 20 years of age were categorized into 1-year age groups. Their height was measured and the sexual development was assessed based on breast development (BD) and pubic hair growth (PH) stages 1-5 on the basis of Tanner scale. The data was then compared between the two groups using Student's t-test. The mean age of menarche was calculated by applying Probit analysis. Results: The mean height of mentally retarded girls was significantly retarded as compared to normal girls at all ages; however, the mean height gain during 11-20 years was same in both the groups. The mentally retarded girls also showed significant retardation in PH growth at 15-17 years and in BD at 15-16 years of age. Conclusions: The physical growth and sexual development of adolescent mentally retarded girls was retarded as compared to the normal girls. The physical growth retardation occurred during early childhood (before 11 years), however the retardation in sexual maturity occurred during middle adolescence, between 15-17 years of age.