Assessing bias in administrative database studies of RotaTeq vaccine completion due to exclusion of subjects with incomplete follow-up.

IF 3.6 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH
Emerging Themes in Epidemiology Pub Date : 2015-04-18 eCollection Date: 2015-01-01 DOI:10.1186/s12982-015-0027-6
Stephan Lanes, Scott C Quinlan, T Christopher Mast, Sander Greenland, Crystal N Holick
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引用次数: 6

Abstract

Background: RotaTeq® pentavalent human rotavirus vaccine (RV5) is effective against rotavirus illness and rotavirus-related hospitalizations and death. Effectiveness depends on adherence to the dosing schedule, which includes 3 doses at ages 2, 4 and 6 months. Two studies have used automated claims databases to estimate the proportion of vaccinated infants who complete the dosing schedule, but excluded from analysis vaccinated infants who were not enrolled in the database for a sufficient period to observe all 3 doses. Restricting study populations based on duration of follow-up can introduce bias if a large number of subjects are excluded due to insufficient follow-up, and if their outcomes differ from subjects who are included. To address the possibility that exclusions may have been extensive and led to biased estimates of completion rates, we conducted a claims database analysis in the HealthCore Integrated Research Database(SM) to evaluate the proportion of rotavirus vaccinated infants who completed the 3 dose series of RV5. We evaluated potential error introduced by restricting analyses to infants with complete follow-up by estimating completion rates among infants with complete follow-up, and using Kaplan-Meier analyses to estimate completion rates including infants with incomplete follow-up.

Results: The inclusion criterion requiring continuous enrollment for the first year of life resulted in only 108,533 (40%) of 233,143 vaccinated infants from 2006-2012 being included in the analysis. After relaxing inclusion criteria, we were able to include 86% of vaccinated infants. The estimated completion rate among infants with continuous enrollment from birth through the first year of life was 78.1% (95% confidence limits [CLs] 77.8%, 78.3%), and among the expanded population the estimated completion rate was 77.4% (95% CLs 77.2%, 77.6%).

Conclusions: These results indicate that most infants were not followed in the database through the first year of life, but the impact of excluding infants with incomplete follow-up was negligible when assessing RV5 completion rates for this commercially insured population. Nonetheless, to increase the size of study populations and reduce the potential for bias, it is preferable to include subjects with incomplete follow-up in automated database analyses, and adopt more robust approaches to defining and analyzing study populations that account for missing data.

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Abstract Image

由于排除了随访不完全的受试者,评估RotaTeq疫苗完成的行政数据库研究的偏倚。
背景:RotaTeq®五价人轮状病毒疫苗(RV5)对轮状病毒疾病和与轮状病毒相关的住院和死亡有效。有效性取决于是否遵守给药计划,包括在2个月、4个月和6个月时给药3次。两项研究使用自动索赔数据库来估计完成给药计划的接种婴儿的比例,但在分析中排除了未在数据库中登记足够时间以观察所有3种剂量的接种婴儿。如果由于随访不足而排除了大量受试者,并且受试者的结果与纳入的受试者不同,根据随访时间限制研究人群可能会引入偏倚。为了排除可能存在的广泛排除并导致对完成率估计有偏差的可能性,我们在HealthCore综合研究数据库(SM)中进行了索赔数据库分析,以评估完成3剂RV5系列轮状病毒疫苗接种的婴儿的比例。我们通过估计完全随访的婴儿的完成率来评估限制在完全随访的婴儿的分析所带来的潜在误差,并使用Kaplan-Meier分析来估计包括不完全随访的婴儿的完成率。结果:纳入标准要求在出生后第一年连续入组,结果在2006-2012年期间接种疫苗的233,143名婴儿中,只有108,533名(40%)被纳入分析。在放宽纳入标准后,我们能够纳入86%的接种过疫苗的婴儿。从出生到一岁连续入组的婴儿的估计完成率为78.1%(95%置信限[CLs] 77.8%, 78.3%),在扩大的人群中,估计完成率为77.4%(95%置信限[CLs] 77.2%, 77.6%)。结论:这些结果表明,数据库中大多数婴儿在出生后的第一年没有被随访,但是在评估商业保险人群的RV5完成率时,排除随访不完全的婴儿的影响可以忽略不计。尽管如此,为了增加研究人群的规模并减少潜在的偏倚,最好将随访不完全的受试者纳入自动化数据库分析,并采用更可靠的方法来定义和分析研究人群,以解释缺失的数据。
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来源期刊
Emerging Themes in Epidemiology
Emerging Themes in Epidemiology Medicine-Epidemiology
CiteScore
4.40
自引率
4.30%
发文量
9
审稿时长
28 weeks
期刊介绍: Emerging Themes in Epidemiology is an open access, peer-reviewed, online journal that aims to promote debate and discussion on practical and theoretical aspects of epidemiology. Combining statistical approaches with an understanding of the biology of disease, epidemiologists seek to elucidate the social, environmental and host factors related to adverse health outcomes. Although research findings from epidemiologic studies abound in traditional public health journals, little publication space is devoted to discussion of the practical and theoretical concepts that underpin them. Because of its immediate impact on public health, an openly accessible forum is needed in the field of epidemiology to foster such discussion.
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