Common Data Elements (CDEs) Program
- 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, 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:
- 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)