Wu Zunyou, Rotheram-Borus Mary Jane, Detels Roger, Li Li, Guan Jihui, Liang Guojun, Yap Lorraine
National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.
AIDS. 2007 Dec;21 Suppl 8:S81-7. doi: 10.1097/01.aids.0000304701.93002.00.
This paper describes one option to select populations for randomized, controlled trials (RCT). We used a popular opinion leader intervention in Fuzhou, China, to: (1) identify population selection criteria; (2) systematically examine the suitability of potential target populations and settings; (3) briefly evaluate risk and stability in the population; and (4) evaluate regional and organizational support among administrators and government officials.
After comparing migrant villagers, truck drivers, factory workers, construction workers, and market employees in five regions of China, market employees in Fuzhou were identified as the optimal target population. Markets were the optimal sites for several reasons: (1) the population demonstrated a sufficient base rate of sexually transmitted diseases; (2) the population was stable over time; (3) a sufficient number of sites of manageable sizes were available; (4) stable networks existed; (5) local gatekeepers/stakeholders supported the intervention; (6) there was organizational capacity in the local health department to mount the intervention; (7) the demographic profile was similar across potential sites; and (8) the sites were sufficiently distanced to minimize contamination.
Evaluating intervention efficacy in an RCT requires a time-consuming and rigorous process that systematically and routinely documents selection criteria, evaluates multiple populations, sites, and organizations for their appropriateness.
本文描述了一种为随机对照试验(RCT)选择研究人群的方法。我们在中国福州开展了一项广为人知的意见领袖干预措施,以:(1)确定人群选择标准;(2)系统考察潜在目标人群和场所的适宜性;(3)简要评估人群中的风险和稳定性;(4)评估行政人员和政府官员的区域及组织支持情况。
在中国五个地区对农民工、卡车司机、工厂工人、建筑工人和市场雇员进行比较后,福州的市场雇员被确定为最佳目标人群。市场是最佳场所,原因如下:(1)该人群中存在足够比例的性传播疾病发病率;(2)人群随时间保持稳定;(3)有足够数量规模可控的场所;(4)存在稳定的网络;(5)当地把关人/利益相关者支持该干预措施;(6)当地卫生部门具备实施干预的组织能力;(7)潜在场所的人口统计学特征相似;(8)场所之间距离足够远,可将污染降至最低。
在随机对照试验中评估干预效果需要一个耗时且严格的过程,该过程要系统且常规地记录选择标准,评估多种人群、场所和组织的适宜性。