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Evaluation Of Immunization Cards And Parental Recall Against Gold Standard For Evaluating Immunization Coverage.

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Evaluation Of Immunization Cards And Parental Recall Against Gold Standard For Evaluating Immunization Coverage.

The Internet Journal of Epidemiology ISSN: 1540-2614
Evaluation Of Immunization Cards And Parental Recall Against Gold Standard For
Evaluating Immunization Coverage
Giridhara R. Babu MBBS, MBA, MPH, PGMLE PhD candidate Department of epidemiology, University of California
Jørn Olsen MD, Phd Department of Epidemiology, University of California
Sayantee Jana M.Sc. Tutor, Indian Institute of Public Health-Hyderabad
Siddhartha Nandy M.Sc. Tutor, Indian Institute of Public Health-Hyderabad
Muhammad N Farid Phd Candidate Department Of Epidemiology, University Of California
Sadhana SM, MBBS Research Officer, Victoria Foundation
Citation: G.R. Babu, J. Olsen, S. Jana, S. Nandy, M.N. Farid & . Sadhana: Evaluation Of Immunization Cards And Parental
Recall Against Gold Standard For Evaluating Immunization Coverage. The Internet Journal of Epidemiology. 2011 Volume 9
Number 2
Abstract
Introduction
India launched Expanded Programme on Immunization (EPI) in India in 1978 to control Vaccine Preventable Diseases (VPD). In
1978, EPI coverage was included for six diseases: diphtheria, peruses, tetanus, poliomyelitis, typhoid and childhood
tuberculosis. The aim of EIP was to cover 80% of all infants. Subsequently, the programme was universalized and renamed as
Universal Immunization Programme (UIP) in 1985. Measles vaccine was included in the programme and typhoid vaccine was
discontinued. The UIP was phased in from 1985 to cover all districts in the country by 1990, targeting all infants with the
primary Immunization schedule and all pregnant women with Tetanus Toxic Immunization.1 2
Table 1: National Immunization Schedule-India
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Earlier evaluations of routine immunization in India have shown wide differences between reported coverage by local health
agencies compared to evaluated coverage by external agencies. 3 4 5 6 Such differences are often ascribed to attempts by
local health agencies to meet with targets set by themselves or higher agencies. Our study aims at evaluating the quality of
sources of data and the reasons for the large variations in a high-risk district in Karnataka, India. The district of Bellary was
classified high-risk district because it had 18 confirmed cases of Poliomyelitis in the year 2003 and failure to implement routine
immunization services was been given as the predominant reason. Our objective is to evaluate the coverage of immunization in
the district of Bellary and further identify data source with highest reliability against a golden standard.
Subjects and Methods
A community-based study of children aged 0–2 years was carried out in Bellary district during the month of September 2007.
We used multistage cluster sampling for the selection of sample. We collected complete list of talks (administrative blocks in
district) and villages in Bellary district. After considering different sample designs such as simple random sampling, Probability
Proportion to Size (PPS) and EPI 30 X 7 cluster method, we chose systematic random sampling as it assured objectivity of
houses selection and helpful for planning service provision. 7 8 9 10 11 12 The study used a multi stage random cluster sample
of children in the age group of 0-12 months for collection of data.
All the taluks (administrative divisions) in the district were included for the study. In the first stage, two primary health centers
(PHC) were selected in each Taluk based on randomly selected number from random table. In the second stage, in each of the
PHC, two villages were randomly selected from the list of villages using random number table. In the third stage, the surveyors
would pick up the first house randomly and then would select every 3 rd house and conduct interview in 20 houses. First house
will be selected based on the random method of picking up houses. The guideline for picking the first house was that pick any
house randomly from the micro plan prepared for the purposes of implementing polio special immunization rounds (SIAs). The
micro plans for SIAs are updated every round and are expected to be complete for all the villages.
The eligibility criterion for the selection was any house having at least one childbirth in the last two years. Thus the study
period will comprise of calendar years starting from 1st April 2005 till 31st March 2005. From the first house, every 3rd house
visited in the entire village adding up to 20 houses. If any house does not contain any live births in the past two years, the
next house will be selected based on the eligibility criterion.
Figure 1: Scheme followed for selection of samples – Immunization survey
After data check and validation, a total of 1632 parent’s response was included in the survey data. The data corresponds to
information about 1632 children residing in Bellary district, Karnataka.
The participation in the study was voluntary and informed consent was taken from the subjects. The analysis was done at
University of California, Los Angeles with permission of IRB from University of California Los Angeles for data analysis. (IRB#
007-06-084-02)
Sources of Data: First, the collection of information about immunization history was sought from interviews of parents.
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Second, The information regarding immunization was also obtained independent of the information through interview, by cross
checking the details on immunization cards of children. Third, in the event where immunization cards are not available, the
same details were obtained by immunization register maintained in each village by the ICDS worker present in the village.
Finally, the information for BCG scar was obtained by cross checking the BCG scar (Gold standard) present generally on the
lateral side of the left arm. This too was obtained independent of information obtained from the interviews. The information
obtained by first above was classified as parental recall, second and third were classified as card and fourth was classified as
scar.
Data entry and analysis:All the information obtained was entered in a master sheet corresponding to the village by the
interviewer. The coded information was entered village wise in Microsoft excel. The names and all other personal identification
measures were removed from the data before data analysis. Initial data analysis was performed using SPSS for Windows (Rel.
11.0.1. 2001. 17.0, R 2.11. Chicago: SPSS Inc). The output for this paper was generated using SAS software. (Copyright, SAS
Institute Inc. SAS and all other SAS Institute Inc. product or service names are registered trademarks or trademarks of SAS
Institute Inc., Cary, NC, USA.)
Results
Out of the 1630 children were surveyed, we included only 1110 children between 9-24 months of age for our study. This was
because we wanted to check complete immunization status in these children and this could have been done only if they have
completed nine months of age.
Figure 2: Percentage of Completely Immunized children based on type of Data source
We assessed coverage of complete immunization (immunization against all antigens in UIP) according to the source of data; on
the basis of card alone, on the basis of BCG Scar and card and on the basis of parental recall. On analyzing information in
cards, complete immunization was found to be 96%, where as on the basis of parents recall alone, the coverage of complete
immunization was 87%.
Table 2: Status of Complete Immunization – Bellary district
The difference between two sources of data for complete immunization is significant since the confidence intervals are
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non-overlapping. To test the reliability of data source further, we wanted to compare the properties of two sources of data
(parental recall and immunization card) with that of Gold standard (BCG Scar). Administration of BCG to children provides
useful insight since the BCG scar is permanent. Hence the information obtained regarding BCG scar was independently plotted
along with information from parental recall and cards. (Figure.3)
Figure 3: Variations in coverage of BCG (against Tuberculosis) based on data source
The coverage of BCG according to presence of BCG scar in the children was 92.4%. From fig 3, we can infer that information
from cards overestimates the information compared to gold standard (BCG scar), whereas parental recall is more reliable.
We found that the sensitivity of Card for BCG dose history is similar to that of parental recall (overlapping confidence intervals,
Card: 98.9% (97.9-99.5), Parental recall: 97.1% (95.7-98.1). Our results show that parental recall has higher specificity for
capturing history of BCG dose. (Card: 11.7 % (3.8-28.4); Parental recall: 39.1% (27.8-51.6))
Table 3: Properties of Parental recall regarding Immunization history (of BCG card and parental recall compared to BCG Scar as
Gold standard)
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Table 4: Cohen’s Kappa Coefficients (for BCG card and Parental recall compared to BCG Scar as Gold standard)
Discussion
In their analysis of validity of reported coverage in 45 countries, 13Christopher Murray et al have shown that the officially
reported data could be misleading in assessing immunization coverage in developing countries. Hence coverage evaluation
surveys by external agencies are important for determining immunization coverage. Selection of reliable data source becomes
very important in such surveys. There is considerable literature available on evaluation of immunization coverage in different
areas of India. 14 15 16 17 18 19 20 21 22 23 In the recent years, there has been a greater emphasis to rely on the
information from immunization cards in developing countries like India. This can be supported by some studies that have
inferred that parental recall may not be a very good tool for evaluating vaccination history. 24 25 However, all such studies
were done in developed nations and hence need not apply to settings in developing nations.
Accepting results from any one source of data with wide difference can offer challenge to decision makers as the decisions
taken can be completely different. Our study shows that the information from parental recall is close to the data from BCG scar
for BCG, and has higher specificity compared to immunization cards. The overestimation of immunization coverage by cards
can be due to overestimation are errors due to multiple sources of registration, errors due to duplication of entries, lack of
crosschecks, possible errors in data collection and management and exaggerated coverage reports by local health authorities.
26 27
Our study compares sources of data with BCG scar as gold standard for vaccination against Tuberculosis, whereas earlier
studies have used either immunization cards 11 or prospective history 28 as gold standard. Developing countries like India
may not consider either immunization card or prospective history as gold standard to compare other data sources since these
countries have ineffective immunization card utilization absence of any reliable registry data. BCG vaccination offers unique
opportunity to cross check reliability of other data sources by permanent scarring.
For vaccines other than BCG used in UIP, determining a reliable data source poses greater challenge. This challenge is based
on assumption that the vaccine distribution system is efficient and health workers have administered the recommended
vaccines. The absence of gold standards such as BCG scar for other antigens makes it difficult for such comparisons. In the
absence of gold standards, use of modern epidemiological methods can be made for estimation of immunization coverage29 30
31 32 33 .
We had checked B.C.G scar prior to (on the first contact of child) and independently of parental recall for BCG vaccination.
Hence, we think that recall bias due to association of scar and parental recall might have significantly reduced.
We infer that in addition to the existing literature, there is a need of re-examining the stand several agencies of endorsing
immunization cards for evaluation of immunization coverage in Developing Countries. Most importantly, in the absence of gold
standards for other antigens and absence of reliable system for use of immunization cards, parental recall might be the best
available option for nearly reliable source of information in developing countries like India.
Endnotes
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26. A. Singh : Record-Based Immunization Coverage Assessment in Rural North India The Internet Journal of Third World
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27. Jishnu Das, Saumya Das, Trust, learning, and vaccination: a case study of a North Indian village, Social Science &
Medicine, Volume 57, Issue 1, July 2003, Pages 97-112
28. R. Ramakrishnan, T. Venkata Rao, L. Sundaramoorthy and Vasna Joshua,Magnitude of recall bias in the estimation of
immunization coverage and its determinants, Indian Pediatrics 1999; 36: 881-885.
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30. Babu GR (2008). Comment on ‘From risk factors to explanation in public health’. J Public Health 30: 515-516 .
31. Greenland S, Neutra R (1980). Control of confounding in the assessment of medical technology. Int J Epidemiol9:361-367
32. Greenland S, Lash TL (2008). Bias Analysis. In: Rothman KJ, Greenland S, Lash TL (ed). Modern Epidemiology, 3rd edn.
Lippincott Williams & Wilkins, Philadelphia, pp 348-352
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... A similar difference was found in an Indian study with a vaccination coverage rate significantly higher after analyzing vaccination cards than on the basis of parents recall. However, their study found an overestimation of the coverage calculated from immunization cards due to multiple sources of registration, duplication of entries, lack of crosschecks, possible errors in data collection and management and exaggerated coverage reports by local health authorities [14]. ...
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... A similar difference was found in an Indian study with a vaccination coverage rate significantly higher after analyzing vaccination cards than on the basis of parents recall. However, their study found an overestimation of the coverage calculated from immunization cards due to multiple sources of registration, duplication of entries, lack of crosschecks, possible errors in data collection and management and exaggerated coverage reports by local health authorities [14]. ...
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... There is considerable literature available on evaluation of Immunization coverage in different areas of India. [11][12][13][14][15][16][17][18][19][20] Our earlier study 21 showed that the information from parental recall is comparable to the data from BCG scar for BCG, and has higher specificity compared to Immunization cards. [22][23] Third, in the event where immunization cards are not available, the same details were obtained by Immunization register maintained in each village by the ICDS worker present in the village. ...
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The Integrated Child Development Services (ICDS) programme was launched by the Indian government in October 1975 to provide a package of health, nutrition and informal educational services to mothers and children. In 1988 we studied the impact of ICDS on the immunization coverage of children aged 12-24 months and of mothers of infants in 19 rural, 8 tribal, and 9 urban ICDS projects that had been operational for more than 5 years. Complete coverage with BCG, diphtheria-pertussis-tetanus (DPT) and poliomyelitis vaccines was recorded for 65%, 63%, and 64% of children, respectively, in the ICDS population. By comparison, the coverage in the non-ICDS group was only 22% for BCG, 28% for DPT, and 27% for poliomyelitis. Complete immunization with tetanus toxoid was recorded for 68% of the mothers in the ICDS group and for 40% in the non-ICDS group. Coverage was greater in the urban and lower in the tribal projects. Scheduled castes, scheduled tribes, backward communities, and minorities (groups that have a high priority for social services) had immunization coverages in ICDS projects that were similar to those of higher castes.
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Precision in estimation of relative risks using a standardized sampling method proposed by the WHO Global Programme on AIDS was evaluated using a Monte Carlo model simulating actual populations; the proposed survey design represents a modification of the methodology used by the WHO Expanded Programme on Immunization (EPI) to estimate immunization coverage among children. This study suggests that in actual populations the proposed survey strategy is a reasonable alternative to the use of simple random sampling (SRS) at the second stage of cluster sampling. Although varying such population characteristics as the seroprevalence rate, nonresponse rate, and rate of misclassification of exposure failed to demonstrate a clear advantage of one method over the other, the added cost and difficulty of implementing SRS under field conditions warrant further consideration of the EPI-like methodology for use in estimating relative risks.