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The goal of Project CODE-PRO (Capturing Opioid Use Disorder Electronically and Patient Reported Outcomes) was to build clinical data research infrastructure that will begin to enhance capacity to use electronic health record (EHR) data and patient reported outcomes measures (PROs) to conduct opioid related research in emergency departments (EDs). The project builds data capacity for research in four main areas, including standardized collection of standardized clinical data, collection of participant provided information, linking of clinical and other data for research, and use of clinical data for research in ED settings. As such, the project included three distinct tasks and objectives, including:

1. Identifying existing or potential common data elements (CDEs) for OUD that are relevant to the ED setting (Task 1)
2. Demonstrating that CDEs from the EHRs can be transmitted or integrated into the American College of Emergency Physicians (ACEP) Clinical Emergency Data Registry (CEDR) (Task 2)
3. Exploring the feasibility and acceptability of collecting PRO measures electronically in patients with non-medical opioid use in the ED setting (Task 3)

Together, these tasks were designed to improve interoperability and linkages between EHRs, research networks and registries for research relevant to the opioid epidemic. Enhanced clinical data research infrastructure in ED settings has the potential to facilitate research to address key strategic priorities, such, as improving access to treatment and recovery services, promoting use of overdose-reversing drugs, providing support for cutting edge research on addiction and pain, and advancing better practices for management of OUD and pain.

Related protocols: CTN-0081

In November 2008, the CTN Executive Committee approved the formation of an ad hoc task force to address two goals and make a recommendation to the CTN Steering Committee. The first of these goals was to develop a clinically meaningful outcome standard for drug use to be used in CTN clinical trials, as well as a method to capture that outcome. The second goal was to recommend a set of key screening and assessment questionnaires and instruments to be used CTN-wide. This document represents the task force’s recommendations, including discussion of the importance of capturing drug use consequence information as well as information about successful or failed abstinence, examination of the strengths and weaknesses of various screening instruments, and a comparison of the task force’s recommendations with the CTN Common Assessment Battery (CAB).

The Methamphetamine and Other Drugs (MOD) in American Indian and Alaska Native communities (AIAN) project grew from NIDA?s commitment to reducing health disparities with a specific emphasis on a better understanding of the epidemiology and treatment of drug abuse, and its health consequences in minority populations in general, and AIAN communities in particular. Because few data exist on methamphetamine and other drug use in AIAN communities, NIDA’s National Drug Abuse Treatment Clinical Trials Network (CTN) funded several exploratory and developmental projects in order to develop collaborative research partnerships with AIAN communities. Each participating Node has specific processes in place for reporting and disseminating research findings that require Tribal approval from its respective research partners and findings from these projects will be presented in future publications and at professional meetings — in full partnership with our community research partners.

The purpose of this brief report is to describe the process followed by each of the Nodes as they have developed their research partnerships with AIAN communities; lessons learned and recommendations for others interested in ethical research with AIAN communities are also presented.

Related protocols: CTN-0033-Ot, CTN-0033-OT-1, CTN-0033-Ot-2, CTN-0033-Ot-3, CTN-0033-Ot-4, CTN-0033-Ot-5