Common Data Elements (CDEs) Program
- About the Common Data Elements (CDE) Program
- What is a common data element (CDE)?
- What are the core CDEs?
- 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, clinical pain research grantees collaborate and agree to use common data elements for patient-reported outcomes (PROs).
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:
- 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: 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)
A detailed description of the domain and measurement 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.
All core measures outside of the demographic questions must be asked at a minimum of two times (baseline and follow-up). The NIH HEAL Initiative also requires that clinical pain studies monitor opioid use, but studies have discretion over how it is measured (patient-reported outcome, electronic health records, or otherwise).
Required demographic information for both adult and pediatric studies are:
- Date of Birth
- 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.
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|
Pediatric Acute and Chronic Pain
|Respondent||Pain Intensity||Pain Interference||Physical Functioning/AOL||Sleep||Pain Catastrophizing||Depression||Anxiety||Global Satisfaction with Treatment||Substance Use Screener|
|Child||BPI Pain Severity||BPI Pain Interference||PedsQL Inventory||AWS+ Sleep Duration Items||Pain Catastrophizing Scale for Children||PHQ-2 or PHQ-8* or PHQ-9*||GAD-2 or GAD-7*||PGIC||NIDA Modified Assist Tool - 2|
|N/A||N/A||N/A||N/A||Pain Catastrophizing||PHQ-2 or PHQ-8* or PHQ-9*||GAD-2 or GAD-7*||N/A||N/A|
*For these domains, longer-form versions of the questionnaires are acceptable for collecting this information. While the shorter versions listed can be found in the Core Questionnaires folders, the longer versions can be found in the Supplemental Folders.
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 measures have been copyrighted.
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
What are supplemental CDEs?
In addition to the core CDEs, the NIH HEAL Initiative has identified hundreds of potential supplemental questionnaires that may be used depending on a study’s subject matter. Investigators also will be asked to submit supplemental questionnaires that they plan to use and that are not already available within the HEAL CDE Program, to ensure there can be uniform collection of data that ensures compatibility across studies as the field considers unique or innovative research questions. The full list of supplemental questionnaires can be accessed by contacting [email protected].
The NIH HEAL Initiative will provide web-based access to clinical pain case report forms (CRFs) and CDE details that can be utilized to conduct secondary analyses.
Study teams are not required to use the supplemental measures. However, if a study does use one of these measures, it will be required to use the NIH HEAL Initiative CDE details that are provided (variable names, variable coding, etc.).
Investigators planning to use Spanish-language supplemental measures are responsible for sending NIH the Spanish-language CRF.
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 of pain domains will lead to a more nuanced understanding of how pain affects different patients 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 patients 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.
NIH HEAL Initiative clinical pain data 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 experience 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 database of CDEs and associated case-report forms (questionnaires) are available upon request. For more information, please contact: [email protected].
NIH HEAL Initiative clinical studies 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.
If your study is planning to use a supplemental measure that is not on the list of measures that have been converted, please email [email protected] with the following information:
- Name of the measure
- Copy of the CRF (English and Spanish – if applicable)
- Reference for the CRF
- Scoring instructions for the CRF
The NIH HEAL Initiative will convert the CRF into a document that meets accessibility requirements and may be used by other studies, and will create a spreadsheet with CDE details so that data generated is consistent across studies.
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 your questionnaire is not already included in the supplemental CDEs, it can be considered for inclusion by the HEAL CDE Program team by contacting [email protected].
All new NIH HEAL Initiative clinical pain studies are required to submit their case-report forms/questionnaires to the CDE Program. The program will create the CDE files containing standardized variable names, responses, coding, and other information. The program 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) if applicable, instructions about how to score the questionnaire, and 3) a copy of the questionnaire.
New investigators must submit their list of questionnaires, case-report forms, references, and scoring instructions 3 months in advance of their study’s anticipated start.
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The HEAL Data Ecosystem aims to transform research data, findings, and publications into a virtual, annotated, searchable catalog in which datasets and findings from different studies can be analyzed, compared, and combined.
Public Access and Data Sharing Plan
Through the NIH HEAL Initiative Public Access and Data Sharing Policy (the Policy), NIH seeks to create an infrastructure that addresses the need for researchers, clinicians, and patients to collaborate.
Access the HEAL Platform
Visit the HEAL Platform to search for HEAL-funded studies, access and analyze data, and more.
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