Department of Epidemiology and Medical Statistics, Peking Union Medical College.
Int J Med Sci. 2009 Oct 28;6(6):329-37. doi: 10.7150/ijms.6.329.
To assess the validation of a novel control selection design by comparing the consistency between the new design and a routine design in a large case-control study that was incorporated into a nationwide mortality survey in China.
A nationwide mortality study was conducted during 1989-1991. Surviving spouses or other relatives of all adults who died during 1986-1988 provided detailed information about their own as well as the deceased person's smoking history. In this study, 130,079 males who died of various smoking-related cancers at age 35 or over were taken as cases, while 103,248 male surviving spouses (same age range with cases) of women who died during the same period and 49,331 males who died from causes other than those related to smoking were used as control group 1 and control group 2, respectively. Consistency in the results when comparing cases with each of the control groups was assessed.
Consistency in the results was observed in the analyses using different control groups although cancer deaths varied with region and age. Equivalence could be ascertained using a 15% criterion in most cancer deaths which had high death rates in urban areas, but they were uncertain for most cancers in rural areas irrespective of whether the hypothesis testing showed significant differences or not.
Sex-matched living spouse control design as an alternative control selection for a case-control study is valid and feasible, and the basic principles of the equivalence study are also supported by epidemiological survey data.
通过将新设计与常规设计在一项大规模病例对照研究中的一致性进行比较,评估一种新的对照选择设计的有效性,该研究纳入了中国全国性死亡率调查。
1989 年至 1991 年进行了一项全国性死亡率研究。所有在 1986 年至 1988 年期间死亡的成年人的幸存配偶或其他亲属提供了有关他们自己以及死者吸烟史的详细信息。在这项研究中,将 130079 名年龄在 35 岁或以上因各种与吸烟有关的癌症而死亡的男性作为病例,而将 103248 名年龄与病例相同的女性死亡的幸存配偶(同期)以及 49331 名死于与吸烟无关原因的男性分别作为对照组 1 和对照组 2。评估了将病例与每个对照组进行比较时结果的一致性。
尽管癌症死亡因地区和年龄而异,但在使用不同对照组进行的分析中观察到结果的一致性。在大多数癌症死亡率较高的城市地区,可以使用 15%的标准确定等效性,但在农村地区的大多数癌症中,无论假设检验是否显示出显著差异,都不确定。
对于病例对照研究,性别匹配的幸存配偶对照设计作为对照选择的替代方案是有效且可行的,等效性研究的基本原则也得到了流行病学调查数据的支持。