A retrospective record-linkage study (RLS) based on medical records containing drug prescription histories involves immortal time bias (ITB). Thus, it is necessary to control for this bias in the research planning and analysis stages. Furthermore, a summary of a metaanalysis including RLSs that did not control for ITB showed that specific drugs had a preventive effect on the occurrence of the disease. Previous meta-analytic results of three systematic reviews evaluating the association between statin intake and gastric cancer risk showed that the summary hazard ratio (sHR) of the RLSs was lower than 1 and was statistically significant. We should consider the possibility of ITB in the sHR of RLSs and interpret the results carefully.
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Korean summary
이차자료를 활용하여 구축한 코호트 추적연구는 immortal time bias가 개입될 개연성을 염두에 두어야 한다. 이들 연구결과들을 제외한 메타분석 결과 스타닌 복용에 따른 위암발생 위험 감소는 관련성이 없다는 결과를 도출하였다.
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OBJECTIVES The authors conducted the study to evaluate bias when potentially diseased subjects were included in cohort members while analyzing risk factors of chronic liver diseases. METHODS: Total of 14,529 subjects were followed up for the incidence of liver diseases from January 1993 to June 1997. We have used databases of insurance company with medical records, cancer registry, and death certificate data to identify 102 incident cases. The cohort members were classified into potentially diseased group(n=2,217) when they were HBsAg positive, serum GPT levels higher than 40 units, or had or has liver diseases in baseline surveys. Cox' model were used for potentially diseased group, other members, and total subjects, respectively. RESULTS: The risk factors profiles were similar for total and potentially diseased subjects: HBsAg positivity, history of acute liver disease, and recent quittance of smoking or drinking increased the risk, while intake of pork and coffee decreased it. For the potentially diseased, obesity showed marginally significant protective effect. Analysis of subjects excluding the potentially diseased showed distinct profiles: obesity increased the risk, while quitting smoking or drinking had no association. For these intake of raw liver or processed fish or soybean paste stew increased risk; HBsAg positivity, higher levels of liver enzymes and history of acute liver diseases increased the risk. CONCLUSIONS: The results suggested the potential bias in risk ratio estimates when potentially diseased subjects were included in cohort study on chronic liver diseases, especially for lifestyles possibly modified after disease onset. The analytic strategy excluding potentially diseased subjects was considered appropriate for identifying risk factors for chronic liver diseases.