Visualizing External Validity: Graphical Displays to Inform the Extension of Treatment Effects from Trials to Clinical Practice.
Epidemiology
; 35(2): 241-251, 2024 Mar 01.
Article
en En
| MEDLINE
| ID: mdl-38290143
ABSTRACT
BACKGROUND:
In the presence of effect measure modification, estimates of treatment effects from randomized controlled trials may not be valid in clinical practice settings. The development and application of quantitative approaches for extending treatment effects from trials to clinical practice settings is an active area of research.METHODS:
In this article, we provide researchers with a practical roadmap and four visualizations to assist in variable selection for models to extend treatment effects observed in trials to clinical practice settings and to assess model specification and performance. We apply this roadmap and visualizations to an example extending the effects of adjuvant chemotherapy (5-fluorouracil vs. plus oxaliplatin) for colon cancer from a trial population to a population of individuals treated in community oncology practices in the United States.RESULTS:
The first visualization screens for potential effect measure modifiers to include in models extending trial treatment effects to clinical practice populations. The second visualization displays a measure of covariate overlap between the clinical practice populations and the trial population. The third and fourth visualizations highlight considerations for model specification and influential observations. The conceptual roadmap describes how the output from the visualizations helps interrogate the assumptions required to extend treatment effects from trials to target populations.CONCLUSIONS:
The roadmap and visualizations can inform practical decisions required for quantitatively extending treatment effects from trials to clinical practice settings.
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Neoplasias del Colon
/
Fluorouracilo
Tipo de estudio:
Clinical_trials
/
Prognostic_studies
Límite:
Humans
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Epidemiology
Asunto de la revista:
EPIDEMIOLOGIA
Año:
2024
Tipo del documento:
Article