Opioid Adjunct Drug Therapy: Evaluating Effectiveness Using Text Analytics of Real World Data

By Veronin, Michael; Schumaker, Robert P. | Communications of the IIMA, January-December 2019 | Go to article overview

Opioid Adjunct Drug Therapy: Evaluating Effectiveness Using Text Analytics of Real World Data


Veronin, Michael, Schumaker, Robert P., Communications of the IIMA


INTRODUCTION

Opioid analgesics continue to be the mainstay of pharmacologic treatment of moderate to severe pain. An adjunct is a drug that in its pharmacological characteristic is not identified primarily as an analgesic, but that has been found in clinical practice to have either an independent analgesic effect or additive analgesic properties when used with opioids. By using an adjunct to maximize the level of analgesia, the required opioid dosage may be reduced, together with concomitant adverse effects.

BACKGROUND

Real World Data (RWD) refers to data that describe observations in normal clinical practice obtained by any non-interventional methodology, such as Randomized Controlled Trials (RCTs). The U.S. Food and Drug Administration (FDA) maintains one of the largest government databases in the country, the FDA Adverse Event Reporting System (FAERS). It is comprised of adverse event reports submitted to the FDA through the "MedWatch" reporting program and contains a plethora of Real World Data: thousands of case reports on opioids and adjunct drugs, comprised of unstructured textual data. The objective of this study is to identify the therapeutic effectiveness of adjunct drugs with opioids by examination of narrative text in MedWatch cases.

METHODS

This project follows the traditional approach of knowledge discovery in databases, comprised of five steps: 1) Data selection, 2) Pre-processing, 3) Transformation, 4) Data mining and 5) Interpretation. The strategy employed will transform the narrative text data into an organized and concise summary of key endpoints. An appropriate sample (500 to 1,000 relevant patient cases) that describe opioids and adjunct drugs will be included in the case report data set.

Key task 1: Data selection and pre-processing (Steps 1,2). MedWatch narratives of patient cases that describe the types of opioid and adjunct drug combinations used in real-life clinical settings will be obtained from the FAERS database. …

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