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Identifying optimal dosage regimes under safety constraints: An application to long term opioid treatment of chronic pain.

ABSTRACT: There is growing interest and investment in precision medicine as a means to provide the best possible health care. A treatment regime formalizes precision medicine as a sequence of decision rules, one per clinical intervention period, that specify if, when and how current treatment should be adjusted in response to a patient's evolving health status. It is standard to define a regime as optimal if, when applied to a population of interest, it maximizes the mean of some desirable clinical outcome, such as efficacy. However, in many clinical settings, a high-quality treatment regime must balance multiple competing outcomes; eg, when a high dose is associated with substantial symptom reduction but a greater risk of an adverse event. We consider the problem of estimating the most efficacious treatment regime subject to constraints on the risk of adverse events. We combine nonparametric Q-learning with policy-search to estimate a high-quality yet parsimonious treatment regime. This estimator applies to both observational and randomized data, as well as settings with variable, outcome-dependent follow-up, mixed treatment types, and multiple time points. This work is motivated by and framed in the context of dosing for chronic pain; however, the proposed framework can be applied generally to estimate a treatment regime which maximizes the mean of one primary outcome subject to constraints on one or more secondary outcomes. We illustrate the proposed method using data pooled from 5 open-label flexible dosing clinical trials for chronic pain.

SUBMITTER: Laber EB

PROVIDER: S-EPMC6293986 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Identifying optimal dosage regimes under safety constraints: An application to long term opioid treatment of chronic pain.

Laber Eric B EB Wu Fan F Munera Catherine C Lipkovich Ilya I Colucci Salvatore S Ripa Steve S

Statistics in medicine 20180221 9

There is growing interest and investment in precision medicine as a means to provide the best possible health care. A treatment regime formalizes precision medicine as a sequence of decision rules, one per clinical intervention period, that specify if, when and how current treatment should be adjusted in response to a patient's evolving health status. It is standard to define a regime as optimal if, when applied to a population of interest, it maximizes the mean of some desirable clinical outcom ...[more]

PMID: 29468702

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Project description:ImportanceThe overprescription of pain medications has been implicated as a driver of the burgeoning opioid epidemic; however, few guidelines exist regarding the appropriateness of opioid pain medication prescriptions after surgery.ObjectivesTo describe patterns of opioid pain medication prescriptions after common surgical procedures and determine the appropriateness of the prescription as indicated by the rate of refills.Design, setting, and participantsThe Department of Defense Military Health System Data Repository was used to identify opioid-naive individuals 18 to 64 years of age who had undergone 1 of 8 common surgical procedures between January 1, 2005, and September 30, 2014. The adjusted risk of refilling an opioid prescription based on the number of days of initial prescription was modeled using a generalized additive model with spline smoothing.ExposuresLength of initial prescription for opioid pain medication.Main outcomes and measuresNeed for an additional subsequent prescription for opioid pain medication, or a refill.ResultsOf the 215 140 individuals (107 588 women and 107 552 men; mean [SD] age, 40.1 [12.8] years) who underwent a procedure within the study time frame and received and filled at least 1 prescription for opioid pain medication within 14 days of their index procedure, 41 107 (19.1%) received at least 1 refill prescription. The median prescription lengths were 4 days (interquartile range [IQR], 3-5 days) for appendectomy and cholecystectomy, 5 days (IQR, 3-6 days) for inguinal hernia repair, 4 days (IQR, 3-5 days) for hysterectomy, 5 days (IQR, 3-6 days) for mastectomy, 5 days (IQR, 4-8 days) for anterior cruciate ligament repair and rotator cuff repair, and 7 days (IQR, 5-10 days) for discectomy. The early nadir in the probability of refill was at an initial prescription of 9 days for general surgery procedures (probability of refill, 10.7%), 13 days for women's health procedures (probability of refill, 16.8%), and 15 days for musculoskeletal procedures (probability of refill, 32.5%).Conclusions and relevanceIdeally, opioid prescriptions after surgery should balance adequate pain management against the duration of treatment. In practice, the optimal length of opioid prescriptions lies between the observed median prescription length and the early nadir, or 4 to 9 days for general surgery procedures, 4 to 13 days for women's health procedures, and 6 to 15 days for musculoskeletal procedures.

Dataset Information

Identifying optimal dosage regimes under safety constraints: An application to long term opioid treatment of chronic pain.

Publications

Identifying optimal dosage regimes under safety constraints: An application to long term opioid treatment of chronic pain.

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