Objectives Sources of immunization data include state registries or immunization information systems (IIS), medical records, and surveys. Little is known about the quality of these data sources or the feasibility of using IIS data for research. We assessed the feasibility of collecting immunization information for a national children's health study by accessing existing IIS data and comparing the completeness of these data against medical record abstractions (MRA) and parent report. Staff time needed to obtain IIS and MRA data was assessed. Methods We administered a questionnaire to state-level IIS representatives to ascertain availability and completeness of their data for research and gather information about data formats. We evaluated quality of data from IIS, medical records, and reports from parents of 119 National Children's Study participants at three locations. Results IIS data were comparable to MRA data and both were more complete than parental report. Agreement between IIS and MRA data was greater than between parental report and MRA, suggesting IIS and MRA are better sources than parental report. Obtaining IIS data took less staff time than chart review, making IIS data linkage for research a preferred choice. Conclusions IIS survey results indicate data can be obtained by researchers using data linkages. IIS are an accessible and feasible child immunization information source and these registries reduce reliance on parental report or medical record abstraction. Researchers seeking to link IIS data with large multi-site studies should consider acquiring IIS data, but may need strategies to overcome barriers to data completeness and linkage.
Context The National Children’s Study (NCS) is a longitudinal study of environmental influences on children’s health. Recruitment of a representative birth cohort that will be followed until 21 years of age requires unique approaches across the nationwide study communities. Purpose To describe community outreach and engagement in preparation for household recruitment of women of childbearing age at a rural-classified NCS location that includes 4 adjacent Northern Plains counties spanning 2,500 square miles. Methods Outreach and engagement methods focused on rural community characteristics. The team established an advisory council, conducted outreach meetings with agencies and groups, participated in local events, and collaborated with stakeholders. Study awareness was raised using radio announcements, local television stories, and widespread distribution of print materials through churches, businesses and childcare centers. Impact evaluation examined the number of stakeholder events by type. Outcome evaluation examined the number of households contacted for recruitment, numbers of age-eligible women who completed the screening, and exploration of whether women had heard about the study. Findings Over 300 outreach events occurred, ranging from tribal council meetings to parade entries. Recruitment outcomes were as follows: (a) 80% of 14,700 non-vacant households were reached for potential recruitment, (b) screening interviews were conducted with 89% of the 5,800 age-eligible women identified; (c) 53% of women who completed the screening had heard about the study. Conclusions Outreach targeted to rural communities facilitated strong recruitment outcomes. Collaboration with the cooperative extension service was a unique rural asset that facilitated relevant activities. Participant retention is an ongoing priority.
Validity of prenatal immunization data from different sources has not been assessed. We evaluated prenatal 2009 H1N1 and seasonal influenza (FLU) data obtained from state immunization information systems (IIS), medical record abstraction (MRA), and participant recall using medical care logs (NCS–MCL). 2009 H1N1 and FLU data were obtained from IIS and MRA for 325 pregnant women participating in the National Children’s Study at three locations (SD/MN, NC, WI). Women recalled immunizations at first pregnancy visit and at 16–17 and 36 weeks’ gestation (NCS–MCL). The proportion of women with vaccine information obtainable from each data source was determined, and proportions immunized as determined using different data sources were compared. IIS data were available for 82 %, MRA for 97 %, and NCS–MCL for 93 % of women. No mention of either vaccine occurred in 29 % (range 4–48 %) of IIS, 40 % of MRA (25–59 %), and 59 % (43–82 %) in NCS–MCL. Best agreement between sources was 2009 H1N1 vaccine in MRA versus IIS [kappa (95 % CI) of 0.44 (0.32–0.55)], with poorest agreement for FLU in IIS versus NCS–MCL [0.11 (−0.03 to 0.25)]. IIS was the most sensitive method for identifying women receiving 2009 H1N1 vaccine (92 %); MRA was most sensitive for FLU vaccine (81 %). IIS provided the most complete and sensitive data for 2009 H1N1 immunizations and MRA the most complete and sensitive data for FLU; IIS data were available for a smaller percent of population than MRA. NCS–MCL was the least sensitive method for identifying vaccinated women.
We present a remarkable chain of events in which percutaneous umbilical cord sampling was performed in an attempt to clarify a situation of possible fetal sex chromosome mosaicism in an amniotic fluid culture and led to the discovery that the mother herself had a 45,X/46,XX/47,XXX chromosome constitution. This may have simply represented the chance concurrence of pseudo-mosaicism in the amniotic fluid culture of a woman with an abnormal sex chromosome constitution, but it is also possible that the 45,X colony was maternal in origin. Although clearly a most unusual circumstance, the possibility should be kept in mind when termination of a pregnancy is being considered because of apparent mosaicism in a prenatal diagnostic study.
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