Unintended effects associated with clinical interventions.

Data Element
Study
Description
Research study that the subject is enrolled in
Submitted By: Sandi Mitchell / J P Systems, Inc.
Data Element Information
Data Element Description Research study that the subject is enrolled in
Use Case Description(s)
Use Case Description Use case 6B - MedWatch Form FDA 3500B being used during a clinical trial:

A 64-year old woman (Janet) is participating in a breast cancer clinical trial. As part of her participation in the study, she was instructed to use a specific consumer facing FHIR application to report an adverse event that resulted in any of the following: hospitalization, required help to prevent permanent harm, disability or health problem, birth defect, life-threatening, death, other serious/important medical incident. (This list identifies serious events.)

Janet created an account in the consumer facing FHIR application and imported her health records from her three (3) health systems. The data from her health systems were aggregated to allow her a single view of all her medical information. Janet was able to add more information that was not included in her imported data (OTC drugs, vitamins, etc.).

After receiving the study drug (bresentrik) during a study visit, Janet went home and began vomiting uncontrollably. Her husband called an ambulance and Janet was taken to the hospital where she was treated in the ER and released.
The following morning, Janet opened the study designated consumer facing FHIR application and completed the MedWatch Form FDA 3500B as earlier directed. The form provides her the opportunity to choose to auto fill several of the areas to allow for faster/easier completion of the form (demographics, meds, allergies, conditions, labs). She is given the option to display and choose the relevant items from each category (example: only current meds she is taking, current labs, etc. which might be a subset of her full PHR).

When Janet clicked “Submit” on the electronic form, the data automatically flowed to the investigator (or to whomever was designated to receive the data). The data is then absorbed within the receiver’s system to auto populate a MedWatch Form FDA 3500B for submission to the FDA within 24 hours.
Estimate the breadth of applicability of the use case(s) for this data element (Level 1) – Use cases apply to several care settings or specialties / Criterion #2

An adverse event is the result of an intervention that caused unintentional harm to a specific subject or group of subjects. Examples of adverse events include the administration of an incorrect drug or an incorrect dose of a drug causing an adverse reaction, the use of an implanted device that causes an infection, or a biologic used during a research study that causes unanticipated renal failure. These events are characterized by the need to capture cause-and-effect (although they might not be known at the time of the event), severity, and outcome.

The context of an adverse event is also important. A subject may have condition(s) or current treatments (medications, diet, devices) that impact their response to a newly introduced medication, device or procedure. Knowledge of these variables is essential in establishing a cause-and-effect relationship for an adverse event.

In clinical care, a potential adverse event may also be called a near miss or an error. These are also events but, since they were detected, did not cause harm to a subject. Examples of potential adverse events include a product problem such as a faulty pacemaker that is detected prior implantation, a doctor working simultaneously on two electronic health records realizing the order for a drug was entered on the incorrect patient and then canceling the order, or a patient with a peanut allergy notices that his hospital dinner tray includes peanuts, and he does not eat the peanuts.
Link to use case project page https://confluence.hl7.org/pages/viewpage.action?pageId=49646529#AdverseEventUseCases-UseCase6-AdverseReactionreportingviaFDAMedWatchform
Use Case Description Use Case 7 - Clinical trial / Significant Adverse Event:

This scenario involves a phase 2, clinical study evaluating the safety and efficacy of a new oral agent administered daily for treatment of severe psoriasis unresponsive to FDA-approved treatments. There are two arms of the study – subjects receiving the new oral agent or a placebo. Only the research pharmacist is aware of the arm assignment. The fifth subject enrolled in the trial develops severe hepatic failure complicated by encephalopathy one month after starting the study.

The known risk profile of the new oral agent prior to this event included mild elevation of serum liver enzymes in 10% of subjects receiving the agent during previous clinical studies, but there was no other history of subjects developing clinically significant liver disease. The IRB approved protocol and informed consent document for the study identifies mild liver injury as a risk of the research.

The study sponsors determined that is an unanticipated problem that must be reported because although the risk of mild liver injury was foreseen, severe liver injury resulting in hepatic failure was unexpected in severity; possibly related to participation in the research; and serious.

When Janet clicked “Submit” on the electronic form, the data automatically flowed to the investigator (or to whomever was designated to receive the data). The data is then absorbed within the receiver’s system to auto populate a MedWatch Form FDA 3500B for submission to the FDA within 24 hours.
Estimate the breadth of applicability of the use case(s) for this data element Unknown, but stakeholders include implementors of HL7.org FHIR R4.
Link to use case project page https://confluence.hl7.org/pages/viewpage.action?pageId=49646529#AdverseEventUseCases-UseCase7-Clinicaltrial:significantadverseevent
Use Case Description Use Case 15 - Serious Adverse Event Research Study:

Patient SCHJO on Research Study XYZ, Study ID XYZ-123, Subject number XYZ-123-002. SCHJO was enrolled in the study on 12-Jun-2021 taking Study Medication ABC 10 mg orally daily every morning for atrial fibrillation to prevent thromboembolism. On 2-Dec-2021, the subject XYZ-123-002 was hospitalized with a Gastrointestinal (GI) bleed. The investigator was notified of the event on the day of admission when the patient presented with vomiting a large amount of coffee-ground like hematemesis. The investigator stopped the study drug because the event was “Possibly related” to the study drug. The patient’s hemoglobin dropped to 6.5 g/dL and received 2 units of PRBCs. The patient had an upper endoscopy that showed a moderate amount of bleeding from the esophagus. The site was cauterized, and the patient had no further bleeding after the procedure. The GI bleed resolved within one week after discontinuation of study drug and the patient was discharged on 9-Dec-2021 in good condition.
Estimate the breadth of applicability of the use case(s) for this data element Unknown, but stakeholders include implementors of HL7.org FHIR R4.
Link to use case project page https://confluence.hl7.org/pages/viewpage.action?pageId=49646529#AdverseEventUseCases-Usecase15-SeriousAdverseEventResearchStudyMedication
Use Case Description Use Case 16 - Non-Serious Adverse Event Research Study Medication:

Patient MOUMIC on Research Study DISNEY, Study ID DUCK-828, Subject number DUCK-828-012. MOUMIC was enrolled in the study on 21-Jan-2022 taking Study Medication 20 mg subcutaneously daily every morning for diabetes. At visit 3 on 21-Feb-2022, the patient stated that he had started to experience intermittent headaches on 1-Feb-2022 that were mild. They occurred once a week and resolved with Tylenol but were still ongoing. The investigator said the headaches were “UNLIKELY RELATED” to study drug. The action taken with the study treatment was the “DOSE NOT CHANGED” and the outcome was noted to be “NOT RECOVERED/NOT RESOLVED”.
Estimate the breadth of applicability of the use case(s) for this data element Unknown, but stakeholders include implementors of HL7.org FHIR R4.
Link to use case project page https://confluence.hl7.org/pages/viewpage.action?pageId=49646529#AdverseEventUseCases-Usecase16-Non-SeriousAdverseEventResearchStudyMedication
ONC Priority
  • Address public health interoperability needs of reporting, investigation, and emergency response
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) HL7.org FHIR R4 v4.0
https://hl7.org/fhir/R4/
Additional Specifications https://github.com/HL7/fhir-ae-care-ig.git
Current Use (Level 1) Captured, stored, or accessed in at least one production EHR or HIT module
Extent of exchange (Level 1) Between two production EHRs or other HIT modules using available interoperability standards
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) None
Restrictions on Use (e.g. licensing, user fees) None
Privacy and Security Concerns Standard HIPAA concerns.
Estimate of Overall Burden Unknown burden to implement; however, the need for implementation is enormous. COVID-19 pandemic required use of adverse event reporting. It is expected this need will continue and expand.
ASTP Evaluation Details
Each submitted Data Element has been evaluated based on the following criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI
Criterion #1
Maturity - Current Standards		 Level 2 - Data element is represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Criterion #2
Maturity - Current Use 		Level 1 - Data element is captured, stored, or accessed in at least one production EHR or HIT module.
Criterion #3
Maturity - Current Exchange		 Level 1 - Data element is electronically exchanged between two production EHRs or other HIT modules using available interoperability standards.
Criterion #4
Use Case(s) - Breadth of Applicability		 Level 0 - Use cases apply to a limited number of care settings or specialties, or data element represents a specialization of other, more general data elements.
Evaluation Comment This data element represents a specialized use or subset of an existing Level 0 data element Outcomes in the Outcomes data class in USCDI https://www.healthit.gov/isa/taxonomy/term/7869/level-0.

Comment

Log in or register to post comments

FormGuide

Help

1. Optional: Background Text / Cover Letter

The "Optional Background Text / Cover Letter" field provides space for additional context or introductory information related to your comment.

If you wish to provide context, explanation, or an introduction to your comment, enter this information in the field labeled "Optional Background Text / Cover Letter." This is entirely optional and is most useful when submitting multiple related comments or when additional background would help reviewers understand your feedback.

If you are only commenting on a single data class or element, you may leave this field blank.

2. Select the Data Class

To specify which data class your comment addresses:

  1. In the "Data Class" drop-down menu, select the appropriate data class you want to comment on.
  2. If you are providing a general comment that is not specific to a data element, select "General" from the options. Comments with this designation will be displayed on the USCDI landing page.
  3. Note that the Data Class field will automatically populate based on your current location in the platform:
    1. If you are on a data class page, the field will be set to that specific data class
    2. If you are on a data element page, the corresponding data class will be pre-selected
       

3. Select the Data Element

To specify which data element your comment addresses:

  1. In the "Data Element" drop-down menu, select the specific data element you want to comment on.
  2. The drop-down menu will display only the elements available under the data class you selected in the previous step.
  3. You can use the search function within the drop-down to quickly locate a specific data element.
  4. If you are commenting on the data class itself rather than a specific element, you may leave this field blank.

Note: Comments on a specific data element will appear on the respective data element page, while comments on a data class (without a specific element selected) will appear on the landing page for that data class.
 

Data Class and Data Element

Fig 1 The "Data Class" and "Data Element" dropdown menus allow users to specify the exact content they wish to comment on.

4. Optional: Propose New Data Class or Element

If you cannot find the appropriate data class or element for your comment:

  1. Instead of clicking the "Comment On An Existing Data Class Or Element" button, click the adjacent button labeled "Propose a New Data Class or Data Element."
  2. This will redirect you to the ONDEC (ONC New Data Element and Class) Submission System.
  3. In the ONDEC system, follow the provided instructions to submit your proposal for a new data class or element.
  4. Once your proposal is submitted through ONDEC, it will be reviewed separately from the commenting process.
Propose New Data Class or Element

Fig 2 The "Propose a New Data Class or Data Element" button redirects users to the ONDEC Submission System for proposing new data elements not currently available in the system.

5. Complete the Comment Form

Fill out the required fields in the comment form:

Subject: Enter a brief, descriptive title that summarizes your comment. This helps reviewers quickly understand the nature of your feedback.

Comment: In this field, provide the full details of your comment or feedback. Be as clear and specific as possible about your suggestions, concerns, or observations. Include any relevant details that support your position.

6. Optional: Add Additional Comments

If you need to comment on multiple data classes or elements:

  1. After completing your first comment, click the link labeled "Comment on another data element" at the bottom of the form.
  2. A new comment section will appear, allowing you to enter details for your additional comment.
  3. For each additional comment, you must select the appropriate data class and data element from the drop-down menus.
  4. Complete the Subject and Comment fields for your additional comment.
  5. Repeat this process for each additional comment you wish to submit.

Fig 3 The "Comment on another data element" link enables users to create multiple comments addressing different elements within a single submission.

7. Optional: Upload Supporting Files

The platform allows you to upload supporting documentation to enhance your comment:

  • Locate the "File Upload" section at the bottom of the comment form.
  • Click to upload any files (such as PDFs or documents) that provide additional context, evidence, or clarification for your comment.

Important: If you have already entered your comments using the form fields, there is no need to upload duplicate content in PDF format. The file upload feature is intended for supplementary materials only. Please avoid uploading files that contain the same information already provided in your comment text.

Upload Supporting Files

Fig 4 The "File Upload" section permits users to attach supporting documentation that supplements their written comments.

8. Optional: Save and Exit

If you need to pause your work and return to complete your comment later:

  1. Click the "Save and Exit" button at the bottom of the form.
  2. Your comment will be saved as a draft that you can access and complete later.
  3. When you return to the platform, you will see a red triangle with an exclamation mark next to the “Return to saved Comment” button, indicating that you have saved comments in draft status.
  4. Click this button to continue working on your draft.
  5. You will be taken to a review page where you can:
    1. Select "Submit Comment" to officially submit your feedback.
    2. Click "Edit" to return to the comment form and make changes
    3. Select "Discard Draft" to delete the saved draft and start fresh

Fig 5 A red triangle with exclamation mark indicator appears next to the “Return to saved Comment” button when draft comments are saved in the system.

9. Review and Submit

Once you have completed your comment:

  1. Click the "Review and Submit" button at the bottom of the form.
  2. This will take you to a review screen displaying your comment(s) in full.
  3. Review all information for accuracy and completeness.
  4. On this review screen, you have three options: 
    1. Click "Submit Comment" to officially submit your feedback
    2. Click "Edit" to return to the comment form and make changes
    3. Click "Discard Draft" to delete the comment and start fresh
  5. The review screen also includes a "Print" button that allows you to create a printed copy of your comments for your records. 
  6. If you choose to submit, your comment will be recorded in the system and made available for review by the appropriate stakeholders.
Review and Submit

Fig 6 The review screen allows users to verify comment content and make any necessary modifications before final submission.

USCDI Comments

Close

Add a New Comment

Review comment and Submit

Edit
Comment #1