Common Data Elements (CDEs) Program

On this page:

• About the Common Data Elements (CDE) Program
• What is a common data element (CDE)?
• What are the core CDEs?
• REDCap Data Dictionaries
• What are supplemental CDEs?
• What are the benefits of the CDE Program?
• How can I access the core and supplemental CDEs?
• What is expected of your study?
• How can my questionnaire be included in the supplemental CDEs?

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, pain research grantees studying human subjects 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 pain research portfolio that include human subjects) are strongly encouraged to search for applicable CDEs within the HEAL CDE Repository, and use questionnaires from this database where 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 human subject 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 pain research studies involving human subjects are required to collect a core group of CDEs, a minimal and defined set of PROs, for ten of the most important domains for pain. Investigators can also 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 ten core pain domains and the appropriate questionnaires that studies should use to collect these data.

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). (Cook et al., 2013; 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). (National Institute on Drug Abuse Clinical Trials Network, 2016)
   
• 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.  (International Society for Quality of Life Research, 2019;Pogatzki-Zahn et al., 2021)
   
• Sleep: Perceptions of difficulty falling asleep, sleep quality, sleep depth, duration and restoration associated with sleep. (Harvey et al., 2008; 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. (Sullivan et al., 1995)
   
• Depression: Persistent feeling of sadness, irritability, emptiness or a loss of pleasure and/or interest in activities. (World Health Organization, 2021)
   
• Anxiety: An emotion characterized by feelings of worried thoughts, nervousness and tension. (American Physiological Association, 2010; Mayo Clinic, 2018)
   
• Global satisfaction with treatment: Participant’s perception of changes in pain following treatment. (Perrot and Lantéri-Minet, 2019)
   
• 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). (Gryczynski et al., 2017)
   
• 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. (Whoqol Group., 1997) 

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
• Rural Urban Commuting Area (RUCA) code - User-friendly tool to batch numbers and export a file
• Social Determinates of Health (SDoH)

Prescription Opioid Use:

The NIH HEAL Initiative requires that  pain studies involving human subjects 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.

Core questionnaires that are copyrighted: 
BPI Pain Interference; PedsQL Inventory; Pain Catastrophizing Scale (Short Form 6)

Core questionnaires with a validated Spanish translation:
BPI Pain Severity; BPI Pain Interference; PEG; PROMIS Physical Functioning Short Form 6b; PROMIS Sleep Disturbance 6a + Sleep Duration Question; Pain Catastrophizing Scale – Short Form 6; PHQ-2; GAD-2; TAPS1.

Core questionnaires without a validated Spanish translation: 
PedsQL Inventory; AWS-10 + Sleep duration Items; Pain Catastrophizing Scale for Children; Pain Catastrophizing Scale – Parent; PGIC; NIDA Modified Assist Tool - 2

The HEAL Initiative core pain questionnaires are posted in the HEAL CDE repository.

Publication:

View full references.

A detailed description of the domain and questionnaire selection process can be found in the following open-access publication. 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.

REDCap Data Dictionaries:

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 Clinical Data Interchange Standards Consortium (CDISC). The PIs are allowing the NIH HEAL Initiative to share the data dictionaries with other HEAL PIs. The REDCap data dictionaries are accessible via the HEAL CDE Box account. For access, please email us at [email protected]. Please note the NIH HEAL Initiative does not endorse the use of one particular data-collection software over another.  

The core questionnaires are also available in Spanish, though some of these translations were done by the National Library of Medicine on behalf of the NIH HEAL Initiative and have not been validated. Some core questionnaires have also been copyrighted.

What are supplemental CDEs?

In addition to the ten required core CDEs, the NIH HEAL Initiative has identified hundreds of potential 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 data for future secondary analyses.

Study teams are not required to use the supplemental questionnaires. However, if a study does use one of these questionnaires, it 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.

Our repository now includes patient-reported outcome questionnaires across dozens of health domains being used by NIH HEAL Initiative studies. We are requesting that newly-funded studies utilize questionnaires that are within our repository. Exceptions will be made on a case-by-case basis if your research is focusing on an area not covered within our current questionnaire offerings. The full list of supplemental questionnaires can be accessed by contacting [email protected].

Some PIs are using 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.

What are the benefits of the CDE Program?

The CDE Program will make it easier to consistently code and harmonize data across studies in a way that is cost-effective and efficient and provides rapid access to data. NIH encourages the use of CDEs in part to create “opportunities for comparison or combination of data from multiple studies.” Secondary data analysis is used to compare interventions across studies or lend statistical power to subgroup analysis to help find solutions for minority populations, rare disease patients, or others who are typically underrepresented in research.

The CDE program will enable an unprecedented opportunity for data harmonization that could help prompt secondary-data analyses that go beyond the purposes of the original data collection.

Other possible benefits of the CDE Program include:

• The ability to compare interventions. CDEs could enable researchers to more easily compare the effects of different interventions and combine study samples to enable analysis of subgroups that may be too small to separately analyze in a single study.  
• Access to a source of preclinical data. The existence of a large, open-source dataset thanks to the harmonized data from across HEAL-funded pain studies and beyond should make it easier to source preclinical information from existing human data, rather than the animal models from which it is typically drawn.
• A better understanding. Requiring the full core set of pain domains will lead to a more nuanced understanding of how pain affects those with lived experience differently, and how different therapies affect the whole spectrum of pain-related effects.
• A larger evidence base. Uniform data collection, in conjunction with access to data and results generated by the NIH HEAL Initiative, will also be useful in the clinical setting, as practitioners could have a better evidence base to help make treatment decisions for people with lived experience in minority groups or with underlying health conditions who may not be well represented in individual studies. Similarly, larger, standardized evidence bases collected with uniform clinical pain measures could help inform coverage decisions by health insurers, and decisions made by federal, state, and local policymakers and government officials who are trying to address opioid misuse and pain.

Data from human subjects in NIH HEAL Initiative pain studies could also help guide future research in unforeseen ways, as it will be available for hypothesis generation and pilot testing to a community of clinical pain investigators with diverse experiences and perspectives. Creating straightforward, secure access to NIH HEAL Initiative data, publications, and research findings enriches the overall data ecosystem and can be used well into the future for new discovery and translation efforts.

How can I access the core and supplemental CDEs?

The HEAL Initiative core pain questionnaires are posted in the HEAL CDE repository.

The database of supplemental CDEs and associated case-report forms (questionnaires) are available upon request. For more information, please contact: [email protected].

NIH HEAL Initiative pain studies involving human subjects that are using copyrighted questionnaires are required to obtain licenses for use prior to initiating data collection. When requesting copyrighted licenses from the organization which holds the copyright, please specify that the license is for a HEAL study when you make the request. Licenses must be shared with the HEAL CDE team and the program officer prior to use of copyrighted materials.

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

What is expected of your study?

Review the core CDEs that you will be required to use. NIH will purchase the licenses for the copyrighted core CDEs.

After your grant is awarded, please reply to messages sent by the NIH HEAL CDE Program managers ([email protected]) in a timely manner and work with them to fill out the intake form to understand which questionnaires your study will be using.

New investigators must use the intake form to submit their list of questionnaires and (if applicable), case-report forms, references, and scoring instructions 3 months in advance of their study’s anticipated start.

If a study plans to use a copyrighted supplemental questionnaire, the study is responsible for buying the license.

How can my questionnaire be included in the supplemental CDEs?

If the NIH HEAL Initiative determines that a new supplemental questionnaire should be added to the HEAL CDE Repository, the Program Managers will create the CDE files containing standardized variable names, responses, coding, and other information. The program staff will also format the case-report forms in a standardized way that is compliant with accessibility standards under Section 508 of the Rehabilitation Act of 1973 (29 U.S.C § 794 (d)), which “require[s] Federal agencies to make their electronic and information technology (EIT) accessible to people with disabilities.”

The HEAL CDE Program will also ask for 1) a reference for the CRF, 2) instructions about how to score the questionnaire (if applicable), and 3) a copy of the questionnaire.

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