Selecting patients for randomized trials: a systematic approach based on risk group.

ABSTRACT:

Background

A key aspect of randomized trial design is the choice of risk group. Some trials include patients from the entire at-risk population, others accrue only patients deemed to be at increased risk. We present a simple statistical approach for choosing between these approaches. The method is easily adapted to determine which of several competing definitions of high risk is optimal.

Method

We treat eligibility criteria for a trial, such as a smoking history, as a prediction rule associated with a certain sensitivity (the number of patients who have the event and who are classified as high risk divided by the total number patients who have an event) and specificity (the number of patients who do not have an event and who do not meet criteria for high risk divided by the

SUBMITTER: Vickers AJ 

PROVIDER: S-EPMC1609186 | biostudies-literature | 2006 Oct

REPOSITORIES: biostudies-literature