搜搜做题作业网英译汉 手动翻译高手进---十万个感谢
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英译汉 手动翻译高手进---十万个感谢
Clinical trials usually have a primary (ONE) endpoint.
Of course, investigators usually want more, as ne single outcome rarely captures the totality of information we desire to declare a treatment successful.
How do you choose an appropriate endpoint? A good
endpoint focuses on defined clinical events. They are
usually clinically meaningful outcomes, such as being
free of a particular bacteria, return of normal function,
ability to return to work, and so on. In myasthenia
gravis, a single clear outcome is often hard to define.
It might be return to function, or it could be reducing
the amount of depression experienced in one patient,
but the cushingoid symptoms in another. These are individual
treatment goals, but often too individualized for a trial result. Many times we seek simpler measures that are markers for clinical outcomes. These markers can fall into a class we call surrogates.
Prentice2 defines a surrogate endpoint in an extremely
rigorous manner. He calls “a response variable
[i.e., the surrogate endpoint] for which a test of the null hypothesis of no relationship to the treatment groups under comparison is also a valid test of the corresponding
null hypothesis based on the true endpoint”.Validation of a surrogate is a very arduous task.
Operationally, a surrogate outcome is considered valid
for a specific condition, if simultaneously the surrogate
is correlated with the true clinical outcome AND
the impact of the intervention on the true clinical outcome
is accurately captured by its effect on the surrogate
outcome. In essence, a change in a surrogate outcome must predict the change in the true clinical outcome. There are extensive evaluations required to meet the demands set forth by Prentice—concurrent validity, predictive validity, response to therapy, and
the capability to explain the effects of treatment on true outcome. Few real or accepted surrogates exist or work!
Clinical trials usually have a primary (ONE) endpoint.
Of course, investigators usually want more, as ne single outcome rarely captures the totality of information we desire to declare a treatment successful.
How do you choose an appropriate endpoint? A good
endpoint focuses on defined clinical events. They are
usually clinically meaningful outcomes, such as being
free of a particular bacteria, return of normal function,
ability to return to work, and so on. In myasthenia
gravis, a single clear outcome is often hard to define.
It might be return to function, or it could be reducing
the amount of depression experienced in one patient,
but the cushingoid symptoms in another. These are individual
treatment goals, but often too individualized for a trial result. Many times we seek simpler measures that are markers for clinical outcomes. These markers can fall into a class we call surrogates.
Prentice2 defines a surrogate endpoint in an extremely
rigorous manner. He calls “a response variable
[i.e., the surrogate endpoint] for which a test of the null hypothesis of no relationship to the treatment groups under comparison is also a valid test of the corresponding
null hypothesis based on the true endpoint”.Validation of a surrogate is a very arduous task.
Operationally, a surrogate outcome is considered valid
for a specific condition, if simultaneously the surrogate
is correlated with the true clinical outcome AND
the impact of the intervention on the true clinical outcome
is accurately captured by its effect on the surrogate
outcome. In essence, a change in a surrogate outcome must predict the change in the true clinical outcome. There are extensive evaluations required to meet the demands set forth by Prentice—concurrent validity, predictive validity, response to therapy, and
the capability to explain the effects of treatment on true outcome. Few real or accepted surrogates exist or work!
临床实验通常有一个第一终点.当然,调查者通常想要更多,单一结果都想要获得全部的信息,我们希望治疗痊愈.你如何选择合适的终点呢?一个好的终点侧重于定义临床实践.它们一般是临床上有意义的成果,例如,无特定细菌的存在,自然功能的返回,恢复体力的能力,等等.在重症肌无力的情况下,一个单一的结果往往难以确定.也许是回到正常生活,或者可以减少患抑郁症的可能性,类库欣氏症表征就得另当别论了.这些都是个别的治疗结果,但是,通常情况下,试验的结果都各不相同.我们为标记临床结果,进行了多次探索.这些标记可以归为一类,我们称之为替代物.学徒2以一种极为谨慎的态度定义替代物终点.他称之为"反应变量".[即
替代物终点]在那些没有任何关系的无效假设的考验下,各治疗组相当有效的测试了基于真正终点上的相对应的无效假设.一个替代物的确认是一项非常艰巨的任务.操作上,在一个替代物结果被视为有效的特定条件下,如果与此同时,替代物将真正的诊断结果和对真正的结果的干预联系起来,那么,这个结果将准确的捕捉到其对替代物的影响.从本质上讲,一个替代结果的变化必须能够预测出真正临床结果的变化.这里有广泛的符合规定要求的评价,关于学徒期同时进行的替代物的有效性,预见的有效性,对治疗的反馈和正确评价治疗效果的能力.很少有真正意义上的能够被接受的替代物的存在或者能真正操作的案例!
替代物终点]在那些没有任何关系的无效假设的考验下,各治疗组相当有效的测试了基于真正终点上的相对应的无效假设.一个替代物的确认是一项非常艰巨的任务.操作上,在一个替代物结果被视为有效的特定条件下,如果与此同时,替代物将真正的诊断结果和对真正的结果的干预联系起来,那么,这个结果将准确的捕捉到其对替代物的影响.从本质上讲,一个替代结果的变化必须能够预测出真正临床结果的变化.这里有广泛的符合规定要求的评价,关于学徒期同时进行的替代物的有效性,预见的有效性,对治疗的反馈和正确评价治疗效果的能力.很少有真正意义上的能够被接受的替代物的存在或者能真正操作的案例!