Measuring the performance of markers for guiding treatment decisions

Treatment selection markers, sometimes called predictive markers, are factors that help clinicians select therapies that maximize good outcomes and minimize adverse outcomes for patients. Existing statistical methods for evaluating a treatment selection marker include assessing its prognostic value,...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:Annals of internal medicine Jg. 154; H. 4; S. 253
Hauptverfasser: Janes, Holly, Pepe, Margaret S, Bossuyt, Patrick M, Barlow, William E
Format: Journal Article
Sprache:Englisch
Veröffentlicht: United States 15.02.2011
Schlagworte:
Biomarkers
Clinical Protocols - standards
Decision Making
Humans
Randomized Controlled Trials as Topic - methods
Randomized Controlled Trials as Topic - standards
Treatment Outcome
ISSN:1539-3704, 1539-3704
Online-Zugang:Weitere Angaben
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
Beschreibung
Zusammenfassung:Treatment selection markers, sometimes called predictive markers, are factors that help clinicians select therapies that maximize good outcomes and minimize adverse outcomes for patients. Existing statistical methods for evaluating a treatment selection marker include assessing its prognostic value, evaluating treatment effects in patients with a restricted range of marker values, and testing for a statistical interaction between marker value and treatment. These methods are inadequate, because they give misleading measures of performance that do not answer key clinical questions about how the marker might help patients choose treatment, how treatment decisions should be made on the basis of a continuous marker measurement, what effect using the marker to select treatment would have on the population, or what proportion of patients would have treatment changes on the basis of marker measurement. Marker-by-treatment predictiveness curves are proposed as a more useful aid to answering these clinically relevant questions, because they illustrate treatment effects as a function of marker value, outcomes when using or not using the marker to select treatment, and the proportion of patients for whom treatment recommendations change after marker measurement. Randomized therapeutic clinical trials, in which entry criteria and treatment regimens are not restricted by the marker, are also proposed as the basis for constructing the curves and evaluating and comparing markers.
Bibliographie:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
ISSN:1539-3704
1539-3704
DOI:10.7326/0003-4819-154-4-201102150-00006