Dataset Information

Intussusception hospitalizations before rotavirus vaccine introduction: Retrospective data from two referral hospitals in Tamil Nadu, India.

ABSTRACT:

Background

The indigenous oral rotavirus vaccine Rotavac® was introduced into the public immunization system in India in 2016 and will be expanded in phases. This data will describe the epidemiology of intussusception in India in absence of rotavirus vaccination and will help in setting up or designing a safety monitoring system.

Methods

Medical records of intussusception cases between 2013 and 2016 in two major referral hospitals in Tamil Nadu, India were reviewed, and data on clinical presentation and management and outcome were collated.

Results

A total of 284 cases of intussusception were diagnosed and managed at the two centers of which 280/284 could be classified as level 1 by the Brighton criteria. Median age at presentation was 8?months (Inter Quartile Range, IQR 6-17.2) with a male to female ratio of 2.1:1. Over half (57.7%) required surgical intervention while the rest underwent non-surgical or conservative management.

Conclusions

Retrospective data from referral hospitals is sufficient to classify cases of intussusception by the Brighton criteria. These baseline data will be useful for monitoring when rotavirus vaccination is introduced.

SUBMITTER: Srinivasan R

PROVIDER: S-EPMC6290388 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Publications

Intussusception hospitalizations before rotavirus vaccine introduction: Retrospective data from two referral hospitals in Tamil Nadu, India.

Srinivasan Rajan R Girish Kumar C P CP Naaraayan Sridevi A SA Jehangir Susan S Thangaraj Jeromie W V JWV Venkatasubramanian S S Kang Gagandeep G

Vaccine 20171202 51

<h4>Background</h4>The indigenous oral rotavirus vaccine Rotavac® was introduced into the public immunization system in India in 2016 and will be expanded in phases. This data will describe the epidemiology of intussusception in India in absence of rotavirus vaccination and will help in setting up or designing a safety monitoring system.<h4>Methods</h4>Medical records of intussusception cases between 2013 and 2016 in two major referral hospitals in Tamil Nadu, India were reviewed, and data on cl ...[more]

PMID: 29199044

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Project description:BACKGROUND:A three-dose, oral rotavirus vaccine (Rotavac) was introduced in the universal immunization program in India in 2016. A prelicensure trial involving 6799 infants was not large enough to detect a small increased risk of intussusception. Postmarketing surveillance data would be useful in assessing whether the risk of intussusception would be similar to the risk seen with different rotavirus vaccines used in other countries. METHODS:We conducted a multicenter, hospital-based, active surveillance study at 27 hospitals in India. Infants meeting the Brighton level 1 criteria of radiologic or surgical confirmation of intussusception were enrolled, and rotavirus vaccination was ascertained by means of vaccination records. The relative incidence (incidence during the risk window vs. all other times) of intussusception among infants 28 to 365 days of age within risk windows of 1 to 7 days, 8 to 21 days, and 1 to 21 days after vaccination was evaluated by means of a self-controlled case-series analysis. For a subgroup of patients, a matched case-control analysis was performed, with matching for age, sex, and location. RESULTS:From April 2016 through June 2019, a total of 970 infants with intussusception were enrolled, and 589 infants who were 28 to 365 days of age were included in the self-controlled case-series analysis. The relative incidence of intussusception after the first dose was 0.83 (95% confidence interval [CI], 0.00 to 3.00) in the 1-to-7-day risk window and 0.35 (95% CI, 0.00 to 1.09) in the 8-to-21-day risk window. Similar results were observed after the second dose (relative incidence, 0.86 [95% CI, 0.20 to 2.15] and 1.23 [95% CI, 0.60 to 2.10] in the respective risk windows) and after the third dose (relative incidence, 1.65 [95% CI, 0.82 to 2.64] and 1.08 [95% CI, 0.69 to 1.73], respectively). No increase in intussusception risk was found in the case-control analysis. CONCLUSIONS:The rotavirus vaccine produced in India that we evaluated was not associated with intussusception in Indian infants. (Funded by the Bill and Melinda Gates Foundation and others.).

Project description:India retains the world's largest burden of anemia despite decades of economic growth and anemia prevention programming. Accurate screening and estimates of anemia prevalence are critical for successful anemia control. Evidence is mixed on the performance of HemoCue, a point-of-care testing device most widely used for large-scale surveys. The use of dried blood spots (DBS) to assess hemoglobin (Hb) concentration is a potential alternative, particularly in field settings. The objective of this study is to assess Hb measurement agreement between capillary HemoCue and DBS among two age groups, children 6-59 months and females age 12-40 years. We analyzed data from the baseline round of a cluster randomized rice fortification intervention in Cuddalore district of Tamil Nadu, India. Capillary blood was collected from a subset of participants for Hb assessment by HemoCue 301 and DBS methods. We calculated Lin's concordance correlation coefficient, and tested bias by conducting paired t-tests of Hb concentration. Independence of the bias and Hb magnitude was examined visually using Bland-Altman plots and statistically tested by Pearson's correlation. We assessed differences in anemia classification using McNemar's test of marginal homogeneity. Concordance between HemoCue and DBS Hb measures was moderate for both children 6-59 months (ρc = 0.67; 95% CI 0.65, 0.71) and females 12-40 years (ρc = 0.67: 95% CI 0.64, 0.69). HemoCue measures were on average 0.06 g/dL higher than DBS for children (95% CI 0.002, 0.12; p = 0.043) and 0.29 g/dL lower than DBS for females (95% CI - 0.34, - 0.23; p < 0.0001). 50% and 56% of children were classified as anemic according to HemoCue and DBS, respectively (p < 0.0001). 55% and 47% of females were classified as anemic according to HemoCue and DBS, respectively (p < 0.0001). There is moderate statistical agreement of Hb concentration between HemoCue and DBS for both age groups. The choice of Hb assessment method has important implications for individual anemia diagnosis and population prevalence estimates. Further research is required to understand factors that influence the accuracy and reliability of DBS as a methodology for Hb assessment.

Dataset Information

Intussusception hospitalizations before rotavirus vaccine introduction: Retrospective data from two referral hospitals in Tamil Nadu, India.

Background

Methods

Results

Conclusions

Publications

Intussusception hospitalizations before rotavirus vaccine introduction: Retrospective data from two referral hospitals in Tamil Nadu, India.

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