%0 Journal Article
%T Using patient management as a surrogate for patient health outcomes in diagnostic test evaluation
%A Lukas P Staub
%A Sarah J Lord
%A R Simes
%A Suzanne Dyer
%A Nehmat Houssami
%A Robert YM Chen
%A Les Irwig
%J BMC Medical Research Methodology
%D 2012
%I BioMed Central
%R 10.1186/1471-2288-12-12
%X We discuss the rationale for measuring patient management, describe the common study designs and provide guidance about how this evidence should be reported.Interpretation of patient management studies relies on the condition that patient management is a valid surrogate for downstream patient benefits. This condition presupposes two critical assumptions: the test improves diagnostic accuracy; and the measured changes in patient management improve patient health outcomes. The validity of this evidence depends on the certainty around these critical assumptions and the ability of the study design to minimise bias. Three common designs are test RCTs that measure patient management as a primary endpoint, diagnostic before-after studies that compare planned patient management before and after testing, and accuracy studies that are extended to report on the actual treatment or further tests received following a positive and negative test result.Patient management can be measured as a surrogate outcome for test evaluation if its limitations are recognised. The potential consequences of a positive and negative test result on patient management should be pre-specified and the potential patient benefits of these management changes clearly stated. Randomised comparisons will provide higher quality evidence about differences in patient management using the new test than observational studies. Regardless of the study design used, the critical assumption that patient management is a valid surrogate for downstream patient benefits or harms must be discussed in these studies.Before a new test is introduced in clinical practice, evidence is needed to demonstrate that its use will lead to improvements in patient health outcomes [1]. Studies reporting test accuracy may not be sufficient, and clinical trials of tests that follow patients over the whole pathway from testing to treatment outcomes, although ideal, are rarely feasible [2]. Therefore, studies investigating the consequences o
%U http://www.biomedcentral.com/1471-2288/12/12