中华流行病学杂志
中華流行病學雜誌
중화류행병학잡지
CHINESE JOURNAL OF EPIDEMIOLOGY
2010年
1期
92-95
,共4页
阶梯设计%随机对照试验%设计延迟%分阶段引入%分阶段实施
階梯設計%隨機對照試驗%設計延遲%分階段引入%分階段實施
계제설계%수궤대조시험%설계연지%분계단인입%분계단실시
Stepped-wedge design%Randomized controlled trials%Designed delay%Staged/ phased introduction%Phased implementation
介绍阶梯设计的基本原理和实施方法,探讨其在随机对照试验中的应用.当研究者希望在一定范围内全面推行某项通常来说"利大于弊"的措施,又想通过随机对照试验来对该措施的效果进行评价,尤其是当资源有限使得本来就只能分步实施干预的时候,阶梯设计非常适用.另外,该方法还可用来发现或控制时间趋势对效果评价的影响.但与传统设计相比,阶梯设计的试验周期更长,统计学问题也要复杂得多.因此,在设计和实施的过程中应严格把握有关注意事项,以保证研究结果的稳健性.
介紹階梯設計的基本原理和實施方法,探討其在隨機對照試驗中的應用.噹研究者希望在一定範圍內全麵推行某項通常來說"利大于弊"的措施,又想通過隨機對照試驗來對該措施的效果進行評價,尤其是噹資源有限使得本來就隻能分步實施榦預的時候,階梯設計非常適用.另外,該方法還可用來髮現或控製時間趨勢對效果評價的影響.但與傳統設計相比,階梯設計的試驗週期更長,統計學問題也要複雜得多.因此,在設計和實施的過程中應嚴格把握有關註意事項,以保證研究結果的穩健性.
개소계제설계적기본원리화실시방법,탐토기재수궤대조시험중적응용.당연구자희망재일정범위내전면추행모항통상래설"리대우폐"적조시,우상통과수궤대조시험래대해조시적효과진행평개,우기시당자원유한사득본래취지능분보실시간예적시후,계제설계비상괄용.령외,해방법환가용래발현혹공제시간추세대효과평개적영향.단여전통설계상비,계제설계적시험주기경장,통계학문제야요복잡득다.인차,재설계화실시적과정중응엄격파악유관주의사항,이보증연구결과적은건성.
In this article, two research cases are employed to show the rationale of the stepped-wedge design, under what situations that such a design is desirable, and how it can be implemented. Stepped-wedge design seems to suit to randomized controlled trials in which the entire study population will receive intervention programs as they would "provide more advantages than harm". When intervention can not be given to all the targets simultaneously due to limited resources, this design is particularly useful. The stepped-wedge design is also relevant when there is a hope to detect or control the time trend effect on the effectiveness of the intervention strategy. On the other hand, however, this design requires longer trial duration and presents a number of statistical challenges. Hence, careful planning and monitoring are essential to ensure that a robust evaluation is undertaken.
