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Assessing treatment-selection markers using a potential outcomes framework.

ABSTRACT: Treatment-selection markers are biological molecules or patient characteristics associated with one's response to treatment. They can be used to predict treatment effects for individual subjects and subsequently help deliver treatment to those most likely to benefit from it. Statistical tools are needed to evaluate a marker's capacity to help with treatment selection. The commonly adopted criterion for a good treatment-selection marker has been the interaction between marker and treatment. While a strong interaction is important, it is, however, not sufficient for good marker performance. In this article, we develop novel measures for assessing a continuous treatment-selection marker, based on a potential outcomes framework. Under a set of assumptions, we derive the optimal decision rule based on the marker to classify individuals according to treatment benefit, and characterize the marker's performance using the corresponding classification accuracy as well as the overall distribution of the classifier. We develop a constrained maximum-likelihood method for estimation and testing in a randomized trial setting. Simulation studies are conducted to demonstrate the performance of our methods. Finally, we illustrate the methods using an HIV vaccine trial where we explore the value of the level of preexisting immunity to adenovirus serotype 5 for predicting a vaccine-induced increase in the risk of HIV acquisition.

SUBMITTER: Huang Y

PROVIDER: S-EPMC3417090 | biostudies-literature | 2012 Sep

REPOSITORIES: biostudies-literature

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Assessing treatment-selection markers using a potential outcomes framework.

Huang Ying Y Gilbert Peter B PB Janes Holly H

Biometrics 20120202 3

Treatment-selection markers are biological molecules or patient characteristics associated with one's response to treatment. They can be used to predict treatment effects for individual subjects and subsequently help deliver treatment to those most likely to benefit from it. Statistical tools are needed to evaluate a marker's capacity to help with treatment selection. The commonly adopted criterion for a good treatment-selection marker has been the interaction between marker and treatment. While ...[more]

PMID: 22299708

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Project description:IntroductionCountries are working hard to improve access to healthcare through Universal Healthcare Coverage. To genuinely address the problems of healthcare access, we need to recognize all the dimensions and complexities of healthcare access. Levesque's Conceptual Framework of Access to Health introduced in 2013 provides an interesting and comprehensive perspective through the five dimensions of access and the five abilities of the population to access healthcare. The objectives of this paper are to identify and analyze all empirical studies that applied Levesque's conceptual framework for access to healthcare and to explore the experiences and challenges of researchers who used this framework in developing tools for assessing access.MethodsA scoping review was conducted by searching through four databases, for studies citing Levesque et al. 2013 to select all empirical studies focusing on healthcare access that applied the framework. An initial 1838 documents underwent title screening, followed by abstract screening, and finally full text screening by two independent reviewers. Authors of studies identified from the scoping review were also interviewed.ResultsThere were 31 studies identified on healthcare access using the Levesque framework either a priori, to develop assessment tool/s (11 studies), or a posteriori, to organize and analyze collected data (20 studies). From the tools used, 147 unique questions on healthcare access were collected, 91 of these explored dimensions of access while 56 were about abilities to access. Those that were designed from the patient's perspective were 73%, while 20% were for health providers, and 7% were addressed to both. Interviews from seven out of the 26 authors, showed that while there were some challenges such as instances of categorization difficulty and unequal representation of dimensions and abilities, the overall experience was positive.ConclusionLevesque's framework has been successfully used in research that explored, assessed, and measured access in various healthcare services and settings. The framework allowed researchers to comprehensively assess the complex and dynamic process of access both in the health systems and the population contexts. There is still potential room for improvement of the framework, particularly the incorporation of time-related elements of access.

Dataset Information

Assessing treatment-selection markers using a potential outcomes framework.

Publications

Assessing treatment-selection markers using a potential outcomes framework.

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