Common Data Elements (CDEs) Program

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About the Common Data Elements (CDE) Program

The NIH HEAL Initiative research portfolio spans a broad array of data types that are a rich resource for future studies. Maximizing the value of data collected through the initiative is part of the initiative’s collective responsibility, given the magnitude of the opioid crisis and needs of individuals experiencing pain and addiction.

The NIH HEAL Initiative’s CDE Program supports the initiative’s Public Access and Data Sharing policy, which requires researchers to develop plans to share their project’s underlying primary data through a repository that is appropriate for the data type and research discipline, and will connect and expose data via the HEAL Platform.

To facilitate cross-study comparisons and improve the interpretability of findings, clinical pain research grantees collaborate and agree to use common data elements for patient-reported outcomes (PROs). 

All HEAL studies collecting data from human participants and planning to use CDEs (even studies outside the clinical pain research portfolio) are strongly encouraged to search for applicable CDEs within the HEAL CDE repository, and use questionnaires from this database if possible. Studies using CDEs, regardless of whether they are part of the HEAL repository, will be required to report which questionnaires are being used.

What is a common data element (CDE)?

CDEs are defined fields describing the data to be collected (e.g., identifying specific variables) along with how to gather the data (e.g., PROs), and how the response is represented in a dataset (e.g., allowable responses or variable coding). CDEs are structured as indivisible units of data. This can be either an individual field (e.g., sex) or multiple fields taken together (e.g., the composite score of a scale).

A common data element can be used in multiple clinical studies, with content standards that can be applied to different data collection models that are dynamic and may evolve over time. CDEs enable interoperability among data systems.

NIH HEAL Initiative clinical pain research studies are required to collect a core group of CDEs, a minimal and defined set of PROs, for nine of the most important domains for pain. Investigators can use supplemental CDEs as appropriate for their study.

What are the core CDEs?

NIH staff, in collaboration with NIH HEAL Initiative investigators and other pain research experts, went through a comprehensive process to identify the nine core pain domains and the appropriate questionnaires that studies should use to collect these data.

The nine core pain domains are:

Demographics:

Required demographic information for both adult and pediatric studies are:

  • Date of Birth
  • Age
  • Sex at Birth
  • Gender Identity
  • Ethnicity, Race
  • Highest Level of Education
  • Employment Status
  • Relationship Status
  • Annual Household Income
  • Applied for Disability Insurance
  • Pain Duration

RUCA Code: As of August 2022, the NIH HEAL Initiative is now asking studies to ask respondents for a postal code and then submit a corresponding RUCA (Rural Urban Commuting Area) code to the HEAL Data Ecosystem. Instructions for obtaining a RUCA code are found on the demographic questionnaire.

User-friendly tool to batch numbers and export a file.

Prescription Opioid Use:

The NIH HEAL Initiative requires that clinical pain studies monitor legitimate prescription opioid use reported in morphine milligram equivalents (MME). Studies must report the following information:

  • Name of opioid
  • Dose of opioid
  • Prescription duration
  • Total days exposed (if different from prescription duration)
  • Days elapsed during follow-up, hospital stay or enrollment (if different)
  • MME conversion factor
    • If known: MME value
      • If MME value is provided, please indicate how it was calculated (i.e., Total Days Supply, On-therapy Days, Fixed Observation Window, or Maximum Daily Dose)

Please note: The TAPS substance use screener is not an acceptable way to monitor this type of opioid use.

The following tables show the questionnaires to be used depending on whether the study focuses on chronic pain or acute pain, or has adult or pediatric study participants.

Adult Acute Pain

Pain Intensity Pain Interference Physical Functioning/QOL Sleep Pain Catastrophizing Depression Anxiety Global Satisfaction with Treatment Substance Use Screener
BPI Pain Severity BPI Pain Interference PROMIS Physical Functioning Short Form 6b PROMIS Sleep Disturbance 6a + Sleep Duration Question Pain Catastrophizing Scale – Short Form 6 or 13-item version* PHQ-2 or PHQ-8* or PHQ-9* GAD-2 or GAD-7* PGIC TAPS 1

Adult Chronic Pain

Pain Intensity Pain Interference Physical Functioning/QOL Sleep Pain Catastrophizing Depression Anxiety Global Satisfaction with Treatment Substance Use Screener
PEG PEG PROMIS Physical Functioning Short Form 6b PROMIS Sleep Disturbance 6a + Sleep Duration Question Pain Catastrophizing Scale – Short Form 6 or 13-item version* PHQ-2 or PHQ-8* or PHQ-9* GAD-2 or GAD-7* PGIC TAPS 1