PRO FHIR IG Proposal

Approved 2018-08-08

Patient Reported Outcomes

Patient Reported Outcomes FHIR IG

Owning work group name

FHIR-I

Committee Approval Date:

2018-02-05

Contributing or Reviewing Work Groups

• Patient Care
• BR&R
• O&O

FHIR Development Project Insight ID

1433

Scope of coverage

The IG is relevant to all organizations using PROs to collect data directly from patients to examine the treatment outcomes. Typically the feedback is obtained on services provided and the effectiveness of the treatments and procedures. This IG can also be used to collect Patient Generated Health Data using mobile devices and apps using standards that are interoperable.

The Scope of the IG is to use the following resources for Patient Reported Outcomes (PROs) capture and exchange.

• Questionnaire
• QuestionnaireResponse
• Observation
• ProcedureRequest

IG Purpose

A landscape analysis on the use of PROs in clinical care and research settings were conducted the outcomes of which have identified the lack of standardization in the creation, administration and sharing of PRO data even if they would help with the outcome for patients. In order to improve the use of PRO data in the clinical workflow the following needs have been identified for standardization • Need to identify relevant PROMs for each domain using defined data elements and vocabularies • Need to enable PROM administration within EMRs • Need to enable PROM administration using apps outside of EMRs • Need to share PROM responses to clinicians, researchers and care managers.

Content location

https://github.com/HL7/patient-reported-outcomes

Proposed IG realm and code

us/patient-reported-outcomes

Maintenance Plan

The current funding for the project expires in September 2019.

The intention is to follow the US Core Model, where the IG is developed and piloted by the various PRO implementers and then transitioned to an appropriate HL7 WG. We also intend to collaborate with Argonaut and other projects implementing Questionnaires and QuestionnaireResponses to increase the adoption base for the Implementation Guide.

Short Description

This IG provides the necessary guidance to use FHIR for Patient Reported Outcomes.

Long Description

A landscape analysis on the use of Patient Reported Outcomes (PROs) in clinical care and research settings were conducted the outcomes of which have identified the lack of standardization in the creation, administration and sharing of PRO data even if they would help with the outcome for patients. In order to improve the use of PRO data in the clinical workflow the following needs have been identified for standardization • Need to identify relevant Patient Reported Outcome Measures (PROMs) for each domain using defined data elements and vocabularies • Need to enable PROM administration within EMRs • Need to enable PROM administration using apps outside of EMRs • Need to share PROM responses to clinicians, researchers and care managers.

Involved parties

ONC

Expected implementations

REACHnet PCORnet CDRN

pSCANNER PCORnet CDRN

New Pilots expected to start in Fall 2018.

Content sources

SDC FHIR IG

Argonaut Questionnaire Work

Example Scenarios

• Creation and Administering a Physical Function PRO to a Patient after a hip replacement and scoring the results prior to their next appointment.

IG Relationships

Reuse SDC FHIR IG profiles of Questionnaire and QuestionnaireResponse as applicable.

Reuse US Core IG profiles for auto population of Questionnaires and converting QuestionnaireResponses to FHIR Resources.

Timelines

Ballot for Comment in September 2018 Cycle

STU Ballot in January 2019 Cycle

The project timelines are driven by new pilots and challenge grants starting in the fall of 2018. These pilots are intending to base their implementation on the IG as an official document to provide a common baseline for all activities.

In addition, there are currently ongoing pilots, who are actively started to use the IG and have started providing feedback and this can be directly captured as part of the ballot process. In addition coordination with Argonaut and the Northwestern Team implementing Questionnaires and PROs provides a good opportunity for collaboration with an existing IG that can be reviewed critically and feedback obtained and incorporated for the STU version.

All of the above activities are driven by the end date of September 2019 before which a robust IG is expected to be published that can be leveraged by PRO implementers including EHR vendors and other organizations.

When IG Proposal Is Complete

When you have completed your proposal, please send an email to FMGcontact@HL7.org