Data Element
Study
Description

Research study that the subject is enrolled in
Submitted By: Sandi Mitchell / J P Systems, Inc.
Data Element Information
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.
ONC 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.

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