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About CDEs

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 data management sharing plans, share and analyze data via the HEAL Data Ecosystem. To facilitate cross-study comparisons and improve the interpretability of data, pain research grantees studying human subjects collaborate and agree to use common data elements for patient-reported outcomes (PROs). The HEAL CDEs encompass numerous domains and are located within the HEAL CDE Repository.

Slides are available here.

What is a common data element (CDE)?

CDEs are defined fields describing the data to be collected (e.g., identifying specific variables) and how the response is represented in a dataset (e.g., allowable responses or permissible values) within an instrument to gather the data (e.g., PROs). 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).

Who are the HEAL CDEs for?

All research studies, whether affiliated with HEAL or not, can adopt and use the HEAL CDEs. For additional information or guidance, please contact heal_cde@hsc.edu.

All NIH HEAL Initiative pain research studies, involving human participants, are required to use the CDEs. Following award issuance, investigators will receive communications from the HEAL CDE Program (heal_cde@hsc.utah.edu) to complete an intake form to identify the CDEs to be utilized.

What are the core CDEs?

NIH HEAL Initiative pain research studies, involving human subjects, are required to collect a core set of CDEs, which are a minimal and defined set of PROs, for ten of the most vital domains for pain. In addition, studies are required to collect data on demographics and prescription opioid use. Studies must report the core CDEs at two timepoints (baseline and follow-up). Investigators may also use supplemental CDEs as appropriate for their study. NIH staff, in collaboration with NIH HEAL Initiative investigators and other pain research experts, conducted a comprehensive process to identify these ten core pain domains along with the recommended questionnaires that studies should use to collect the data. These ten domains also include all of the domains identified by the INTEGRATE-Pain consortium as minimal core sets for chronic and acute pain (). The ten core pain domains are:

• Pain intensity: Magnitude of the pain sensations experienced (in the past 24 hours or past week for acute or chronic pain, respectively). (; Hølen et al., 2006)
• Pain interference: The degree to which there are consequences of pain on aspects of a participant’s life (in the past 24 hours or past week for acute or chronic pain, respectively). ()
• Physical functioning/quality of life (QoL): Difficulty associated with carrying out activities requiring physical actions, such as instrumental activities of daily living, as well as problems with psychological state and social interactions.(; )
• Sleep: Perceptions of difficulty falling asleep, sleep quality, sleep depth, duration and restoration associated with sleep. (; Patient-Reported Outcomes Measurement Information System [PROMIS], 2021)
• Pain catastrophizing: Degree of negative attitudes a participant has towards their, or their child’s, pain experience. ()
• Depression: Persistent feeling of sadness, irritability, emptiness or a loss of pleasure and/or interest in activities. ()
• Anxiety: An emotion characterized by feelings of worried thoughts, nervousness and tension. (; )
• Global satisfaction with treatment: �ʲ����پ������貹�Գ�’s perception of changes in pain following treatment. ()
• Substance Use Screener: Screener for unhealthy use of tobacco, alcohol, illicit drugs, and non-medical prescriptions (in past 12 months for adults, in the past 2 weeks for pediatrics). ()
• Quality of Life (QoL): An individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards, and concerns. ()

Demographics

The following is the collection of a standardized core set of demographic CDEs for both adult and pediatric studies. These demographic CDEs include:

• Date of Birth
• Age
• Sex
• Ethnicity
• Race
• Highest Level of Education
• Employment Status
• Relationship Status
• Annual Household Income
• Applied for Disability Insurance
• Pain Duration
• Rural Urban Commuting Area (RUCA) code -  to batch numbers and export a file
• Social Determinates of Health (SDoH)

Prescription Opioid Use

The NIH HEAL Initiative requires pain studies, involving human subjects, to monitor legitimate prescription opioid use reported in morphine milligram equivalents (MMEs). The TAPS substance use screener is not an acceptable way to monitor this type of opioid use. Studies must report the following information at two timepoints:

• 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)
• 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)

Morphine Milligram Equivalent Online Calculator - For Research Purposes Only

HEAL developed an online calculator that will enable researchers to easily report the prescription opioid use that is required to be included in their studies’ datasets. While HEAL investigators are not required to use this online tool, they are required to report on the prescription opioid use variables above. HEAL clinical pain studies are encouraged to use this online MME calculator to streamline their MME data reporting.

The tool converts participants’ prescription opioid use into variable level meta data to enable cross-study comparisons and to compare four different MME calculation methods to each other. For researchers using this online calculator, the data required on study participants is: medication name, dose, number of doses in the past 24 hours, and prescription duration (in days). The calculator will calculate MME values with or without buprenorphine. Once MME values are calculated, researchers can export the data. For questions related to the Morphine Milligram Equivalent Calculator, please contact: heal_cde@hsc.utah.edu

IMPORTANT: This tool is to be used for research purposes only, not for clinical decision-making. This tool applies to opioids for the purpose of pain management and should not be used for opioids to treat Opioid Use Disorder.

Additional Resources:

• MME Calculator FAQ
• MME Calculator How-to Guide
• MME Calculator Webinar PowerPoint

Reference:

Core Domain CDEs

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

Adult Acute Pain

Adult Chronic Pain

Pediatric (Acute and Chronic Pain)

For studies focused mainly on adolescents, investigators should use the adolescent table. For studies involving early childhood or spanning early childhood through adolescence, investigators should use the early childhood table.

Early Childhood (~ages 0-11 years)

The domains of “substance use” and “pain catastrophizing” do not need to be measured in children younger than 11.

Adolescents (~ages 12-17 years)

All adolescent questionnaires are self-reports, except:

• Prescribed Opioid Use: Can be completed by a parent or study staff
• Demographics: Can be completed by a parent

Parent, Guardian, or Caregiver for Pediatric Studies

For all pediatric participants (ages 0 to 17 years), their parent, guardian or caregiver completes the following questionnaires to provide their own report of these domains. Note that these are not proxy measures.

Pain Catastrophizing	Depression	Anxiety	Quality of Life
PCS for Parents	PHQ-2 or  PHQ-8* or PHQ-9*	GAD-2 or GAD-7*	WHOQOL - 2

Please Note:

• For each domain, data is required from only one of the questionnaires listed.
• Self-report should be prioritized where validated questionnaires are available for children 8 and above.
• PGIC vs. PGIS (**) - The PGIC should be used to evaluate the participants’ perspective on improvement or decline in their pain status from an intervention. The PGIS is used to assess the current state of severity of a condition or of their pain status. Studies that include samples with pain at baseline and an intervention to modify pain should use the PGIC, while studies examining only the state of participant at the end of assessment without applying an intervention or in samples where pain was not present at the beginning of the study should use the PGIS.
• For additional questions on the pediatric core CDEs, please review this Frequently Asked Questions on common queries.

Please contact the HEAL CDE program managers (heal_cde@hsc.utah.edu) if you have questions or need support.

Publication

A detailed description of the domain and questionnaire selection process can be found in the following open-access . Please cite this in any publications that result from your study.

Wandner LD, Domenichiello AF, Beierlein J, Pogorzala L, Aquino G, Siddons A, Porter L, Atkinson J; NIH Pain Consortium Institute and Center Representatives. NIH's Helping to End Addiction Long-term^® Initiative (NIH HEAL Initiative) Clinical Pain Management Common Data Element Program. J Pain. 2021 Sep 9:S1526-5900(21)00321-7. doi: 10.1016/j.jpain.2021.08.005. Epub ahead of print. PMID: 34508905.

If referencing the NIH HEAL Initiative CDE Program in your paper, please cite this web page.

Data Dictionaries - REDCap

Two principal investigators (PI)s have created REDCap data dictionaries for all of the core questionnaires within the HEAL CDE program. The REDCap data dictionaries include HEAL variable names and are mapped to the . REDCap data dictionaries are accessible via the HEAL CDE Box account. For access, please email us at HEAL_CDE@hsc.utah.edu. Please note the NIH HEAL Initiative does not endorse the use of one data-collection software over another.

Spanish Translations

To improve accessibility for Spanish speakers, all core questionnaires are available in Spanish. Several of these measures have been validated in Spanish, while other were translated by the National Library of Medicine on behalf of the NIH HEAL initiative. Below is a list of core questionnaires that have been validated in Spanish:

Adult	Pediatric
BPI Pain Severity	BPI Pain Interference
BPI Pain Interference	CALI-9
PEG	NRS-11
PROMIS Physical Functioning 6b	PROMIS Early Childhood Global Health 8a
PROMIS Sleep Disturbance 6a	PROMIS Pediatric Sleep Disturbance 8a
Pain Catastrophizing Scale	PROMIS Early Childhood Sleep Problems 4a/ 8a
PHQ-2, PHQ-8, PHQ-9	PROMIS Pediatric Depressive Symptoms 6a/ 8a
GAD-2, GAD-7	PROMIS Early Childhood Depressive Symptoms 4a
TAPS1	PROMIS Pediatric Anxiety 8a
	PROMIS Parent Proxy Pediatric Anxiety 8a
	PROMIS Early Childhood Anxiety 8a

What are supplemental CDEs?

In addition to the required core CDEs, the NIH HEAL CDE program has hundreds of supplemental questionnaires that may be used depending on a study’s subject matter. The NIH HEAL Initiative is harmonizing the data that comes from the supplemental questionnaires to help enhance the utilization of the additional data.

Study teams are not required to use supplemental CDEs. However, if a study does use supplemental CDEs, the study will be required to use the NIH HEAL Initiative CDE details that are provided (variable names, variable coding, etc.).

After your grant has been funded, you and your team will work with your Program Officer and our HEAL CDE Program Managers to assess which of the existing supplemental questionnaires would be most appropriate for your study.

All studies must use questionnaires available within the HEAL CDE Repository. Exceptions may be granted on a case-by-case basis for research areas not adequately addressed by the current repository offerings. If a supplemental questionnaire qualifies as an exception, the HEAL CDE Program Managers will request the publication supporting its validation, a copy of the instrument, and any translations, if available. The full list of supplemental questionnaires can be obtained by contacting the HEAL CDE Program Managers at heal_cde@hsc.utah.edu.

PIs may use multiple languages in their studies. Please check the HEAL CDE Box account to see if the HEAL CDE program already has your supplemental questionnaires in the language necessary for your study. If the HEAL CDE program does not have the questionnaire in the language that you need for your study, your team is responsible for acquiring the questionnaire in that language. Once acquired, the HEAL CDE program asks that you share the following with the HEAL CDE program managers:

1. Share the case report form.
2. Indicate who translated the questionnaire – i.e., whether the translation was provided by the developer, found in an article, translated by a translation company, and/or if your study team translated the questionnaire.
3. Indicate whether the questionnaire has been validated in the necessary language – i.e., please share the article that indicates that the questionnaire has been validated in the new language.

Copyrighted CDEs

Certain Common Data Elements (CDEs) are copyrighted and require licenses for use.

Core Copyrighted CDEs

NIH HEAL pain research studies, involving human subjects, are required to use the designated core CDEs. The NIH will obtain the necessary licenses for the following copyrighted core measures:

• BPI Pain Interference
• Pain Catastrophizing Scale
• PedsQL Inventory
• FLACC

Following award issuance, investigators must respond in a timely manner to communications from the HEAL CDE Program Managers (heal_cde@hsc.utah.edu) and complete an intake form. This will initiate the license procurement process.

Supplemental Copyrighted CDEs

For supplemental copyright questionnaires, the responsibility for obtaining the appropriate license rests with the study team. NIH HEAL pain research studies, involving human participants, must secure the required licenses before the initiation of data collection.

Documentation of the license must be provided to both the HEAL CDE Program Managers and the NIH Program Officer prior to implementation.

References