Sensitivity Analysis for Binary Outcome Misclassification in Randomization Tests via Integer Programming

Conducting a randomization test is a common method for testing causal null hypotheses in randomized experiments. The popularity of randomization tests is largely because their statistical validity only depends on the randomization design, and no distributional or modeling assumption on the outcome v...

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Vydané v:	Journal of computational and graphical statistics Ročník 34; číslo 4; s. 1528 - 1541
Hlavní autori:	Heng, Siyu, Shaw, Pamela A.
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	United States Taylor & Francis 02.10.2025 Taylor & Francis Ltd
Predmet:	Accuracy Design-based causal inference Fisher's sharp null Integer programming Matched observational studies Neyman's weak null Randomization Randomization inference Sensitivity analysis Warning randomization inference Neyman’s weak null Fisher’s sharp null integer programming matched observational studies design-based causal inference
ISSN:	1061-8600, 1537-2715
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Abstract	Conducting a randomization test is a common method for testing causal null hypotheses in randomized experiments. The popularity of randomization tests is largely because their statistical validity only depends on the randomization design, and no distributional or modeling assumption on the outcome variable is needed. However, randomization tests may still suffer from other sources of bias, among which outcome misclassification is a significant one. We propose a model-free and finite-population sensitivity analysis approach for binary outcome misclassification in randomization tests. A central quantity in our framework is "warning accuracy," defined as the threshold such that a randomization test result based on the measured outcomes may differ from that based on the true outcomes if the outcome measurement accuracy did not surpass that threshold. We show how learning the warning accuracy and related concepts can amplify analyses of randomization tests subject to outcome misclassification without adding additional assumptions. We show that the warning accuracy can be computed efficiently for large datasets by adaptively reformulating a large-scale integer program with respect to the randomization design. We apply the proposed approach to the Prostate Cancer Prevention Trial (PCPT). We also developed an open-source R package for implementation of our approach. Supplementary materials for this article are available online.
AbstractList	Conducting a randomization test is a common method for testing causal null hypotheses in randomized experiments. The popularity of randomization tests is largely because their statistical validity only depends on the randomization design, and no distributional or modeling assumption on the outcome variable is needed. However, randomization tests may still suffer from other sources of bias, among which outcome misclassification is a significant one. We propose a model-free and finite-population sensitivity analysis approach for binary outcome misclassification in randomization tests. A central quantity in our framework is "warning accuracy," defined as the threshold such that a randomization test result based on the measured outcomes may differ from that based on the true outcomes if the outcome measurement accuracy did not surpass that threshold. We show how learning the warning accuracy and related concepts can amplify analyses of randomization tests subject to outcome misclassification without adding additional assumptions. We show that the warning accuracy can be computed efficiently for large datasets by adaptively reformulating a large-scale integer program with respect to the randomization design. We apply the proposed approach to the Prostate Cancer Prevention Trial (PCPT). We also developed an open-source R package for implementation of our approach. Supplementary materials for this article are available online. Conducting a randomization test is a common method for testing causal null hypotheses in randomized experiments. The popularity of randomization tests is largely because their statistical validity only depends on the randomization design, and no distributional or modeling assumption on the outcome variable is needed. However, randomization tests may still suffer from other sources of bias, among which outcome misclassification is a significant one. We propose a model-free and finite-population sensitivity analysis approach for binary outcome misclassification in randomization tests. A central quantity in our framework is "warning accuracy," defined as the threshold such that a randomization test result based on the measured outcomes may differ from that based on the true outcomes if the outcome measurement accuracy did not surpass that threshold. We show how learning the warning accuracy and related concepts can amplify analyses of randomization tests subject to outcome misclassification without adding additional assumptions. We show that the warning accuracy can be computed efficiently for large data sets by adaptively reformulating a large-scale integer program with respect to the randomization design. We apply the proposed approach to the Prostate Cancer Prevention Trial (PCPT). We also developed an open-source R package for implementation of our approach.Conducting a randomization test is a common method for testing causal null hypotheses in randomized experiments. The popularity of randomization tests is largely because their statistical validity only depends on the randomization design, and no distributional or modeling assumption on the outcome variable is needed. However, randomization tests may still suffer from other sources of bias, among which outcome misclassification is a significant one. We propose a model-free and finite-population sensitivity analysis approach for binary outcome misclassification in randomization tests. A central quantity in our framework is "warning accuracy," defined as the threshold such that a randomization test result based on the measured outcomes may differ from that based on the true outcomes if the outcome measurement accuracy did not surpass that threshold. We show how learning the warning accuracy and related concepts can amplify analyses of randomization tests subject to outcome misclassification without adding additional assumptions. We show that the warning accuracy can be computed efficiently for large data sets by adaptively reformulating a large-scale integer program with respect to the randomization design. We apply the proposed approach to the Prostate Cancer Prevention Trial (PCPT). We also developed an open-source R package for implementation of our approach. Conducting a randomization test is a common method for testing causal null hypotheses in randomized experiments. The popularity of randomization tests is largely because their statistical validity only depends on the randomization design, and no distributional or modeling assumption on the outcome variable is needed. However, randomization tests may still suffer from other sources of bias, among which outcome misclassification is a significant one. We propose a model-free and finite-population sensitivity analysis approach for binary outcome misclassification in randomization tests. A central quantity in our framework is “warning accuracy,” defined as the threshold such that a randomization test result based on the measured outcomes may differ from that based on the true outcomes if the outcome measurement accuracy did not surpass that threshold. We show how learning the warning accuracy and related concepts can amplify analyses of randomization tests subject to outcome misclassification without adding additional assumptions. We show that the warning accuracy can be computed efficiently for large datasets by adaptively reformulating a large-scale integer program with respect to the randomization design. We apply the proposed approach to the Prostate Cancer Prevention Trial (PCPT). We also developed an open-source R package for implementation of our approach. Supplementary materials for this article are available online. Conducting a randomization test is a common method for testing causal null hypotheses in randomized experiments. The popularity of randomization tests is largely because their statistical validity only depends on the randomization design, and no distributional or modeling assumption on the outcome variable is needed. However, randomization tests may still suffer from other sources of bias, among which outcome misclassification is a significant one. We propose a model-free and finite-population sensitivity analysis approach for binary outcome misclassification in randomization tests. A central quantity in our framework is "warning accuracy," defined as the threshold such that a randomization test result based on the measured outcomes may differ from that based on the true outcomes if the outcome measurement accuracy did not surpass that threshold. We show how learning the warning accuracy and related concepts can amplify analyses of randomization tests subject to outcome misclassification without adding additional assumptions. We show that the warning accuracy can be computed efficiently for large data sets by adaptively reformulating a large-scale integer program with respect to the randomization design. We apply the proposed approach to the Prostate Cancer Prevention Trial (PCPT). We also developed an open-source R package for implementation of our approach.
Author	Heng, Siyu Shaw, Pamela A.
Author_xml	– sequence: 1 givenname: Siyu orcidid: 0000-0002-9313-3667 surname: Heng fullname: Heng, Siyu organization: Department of Biostatistics, New York University – sequence: 2 givenname: Pamela A. surname: Shaw fullname: Shaw, Pamela A. organization: Biostatistics Unit, Kaiser Permanente Washington Health Research Institute
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SubjectTerms	Accuracy Design-based causal inference Fisher's sharp null Integer programming Matched observational studies Neyman's weak null Randomization Randomization inference Sensitivity analysis Warning
Title	Sensitivity Analysis for Binary Outcome Misclassification in Randomization Tests via Integer Programming
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