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 principle 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 CDISC. The PIs are allowing the NIH HEAL Initiative to share the data dictionaries with other HEAL PIs. The Redcap data dictionaries can be found on the HEAL CDE Box account. (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 questionnaire 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
The HEAL Initiative core pain questionnaires are posted in the HEAL CDE repository.
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. 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 our 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:
- Share the case report form.
- 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.
- 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 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 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 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.
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, the program managers 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.
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