PCORnet Opioid Surveillance Study

This is a two phase retrospective study. The goal of Phase I is to assess the utility of
PCORnet Common Data Mode (CDM) data to study risk factors, processes, and outcomes related to
opioid use, misuse, and abuse. Based on the results of the Phase I feasibility examination,
Phase II will be conducted and will analyze the relationships between patient- and
provider-level risk factors and policies, and opioid-related outcomes over time and within
geographic regions.

The study will leverage the existing data PCORnet data infrastructure and resources to
achieve its objectives and answer its research questions. Standardized analysis programs will
be distributed to participating sites within the PCORnet Distributed Research Network. Sites
will return aggregate, descriptive counts and summary statistics from regression analyses.
When data are unavailable or analysis is determined infeasible, results will be reported as
such.

The Aims of Phase I are:

1. Generate counts and proportion of patients with exposure (or potential exposure) to
opioids though prescription or dispensing records within a health system.

a. Compare results to CDC.

2. Characterize data elements in PCORnet data and assess suitability for opioid
surveillance.

1. Identify the relevant data elements

2. Examine data completeness and validity

3. Identify data limitations and gaps that limit surveillance

The Aims of Phase II are:

1. Examine whether and to what extent patient-level risk factors, provider processes, and
policies are associated with declines in outcomes of interest.

2. Examine whether and to what extent prescribing guidelines, related policies, processes,
and/or care procedures are associated opioid-related outcomes.

Inclusion Criteria:

• Patients with an opioid exposure (prescription or dispense) or diagnosis from an
encounter on record between 1/1/10-12/31/17.

Exclusion Criteria:

• Patients without an opioid exposure (prescription or dispense) or diagnosis from an
encounter on record between 1/1/10-12/31/17.