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Template Usage Information:

  1. Project Name and ID



Enter the name of the project here: Outcome Criteria Framework Implementation Guide

Project ID: 1633

Complete this section for all “Direct to Normative” ballot projects and when a project proceeds from “Informative to Normative” or “STU to Normative”.

Forward PSS to the TSC (via tscpm@HL7.org); this triggers American National Standards Institute (ANSI) Project Initiation Notification (PINS) submission.

 

TSC Notification:  Informative/STU to Normative 

Date:  Submission date

 

- or -                     Direct to Normative (no STU) (includes reaffirmations)       

 

Identify ISO, IEC or ISO/IEC standard to be adopted in text box below

Enter info here if an ISO, IEC, or ISO/IEC Standard is to be adopted as an American National Standard; Enter the designation of the standard(s) to be adopted:

Includes text from ISO, IEC or ISO/IEC standard: Check here if this standard includes excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption.

Yes

 

No

Select the unit of measure used in the standard; if no measurements are in the standard, select N/A

 

N/A

 

U.S.

Metric

 x

Both

 

Investigative Project (aka PSS-Lite)

Date : 

Check this box when the project is investigative or exploratory in nature, which allows limited project scope definition. Sections 1-Project Name, 2-Sponsoring Group(s)/Project Team, 3a-Project Scope, 3b-Project Need, 3e-Project Objectives/Deliverables/Target Dates, 3i-Project Document Repository, 6b-[Realm, if known], and 6d-[applicable Approval Dates] are required for Investigative Project. Investigative Project specific instructions are highlighted in yellow. An investigative project must advance in two WGM cycles, requiring a full scope statement. Otherwise the project will be closed.

2. Sponsoring Group(s) / Project Team

2.a. Primary Sponsor/Work Group

Primary Sponsor/Work Group
(1 (And Only 1) Allowed)

Clinical Quality Information

2.b. Co-sponsor Work Group(s)

Co-sponsor Work Group(s):

(Enter co-sponsor approval dates in Section 6.d Project Approval Dates)

Clinical Decision Support

Indicate the level of involvement that the co-sponsor will have for this project:
 Request formal content review prior to ballot
x Request periodic project updates. Specify periodduring ballot prep; during ballot reconciliation
 Other Involvement. Specify details here: 

2.c. Project Team

All names should have confirmed their role in the project prior to submission to the TSC.

Project facilitator (1Mandatory)

Michelle Leavy

Other interested parties and their roles


Multi-disciplinary project team (recommended)


     Modeling facilitator

Bob Dolin

    Publishing facilitator

Bob Dolin

    Vocabulary facilitator

Gay Dolin

     Domain expert rep

Michelle Leavy

     Business requirement analyst

Bob Dolin, Yan Heras

     Conformance facilitator (for IG projects)

Bob Dolin

     Other facilitators (SOA, etc)

Peter Emmanuel



Implementers (2Mandatory for STU projects)

FHIR Project Note: The implementer requirement will be handled by the “balloting” project.  Therefore work groups do not fill out the above section.  However, feel free to list implementers specific to your work group’s resources if you know of any.

1) Elimu Informatics

2) OM1

3. Project Definition

3.a. Project Scope

The AHRQ Outcome Measures Framework (OMF) defines six categories of outcomes: Survival, Clinical Response, Events of Interest, Patient-Reported, Resource Utilization, Impact on Non-Participant, and Experience of Care. Using this Framework, expert panels have converged on a core set of outcome definitions and criteria for a number of conditions, including Depression, Asthma, Lung Cancer, Lumbar Spondylolisthesis, and others. Depression outcomes include such items as 'improvement in depressive symptoms', 'suicidal ideation', and 'work productivity'. Lung Cancer outcomes include such items as 'progression', 'disease-free survival', 'healthcare utilization'. Asthma outcomes include such items as 'exacerbation', 'asthma control', 'quality of life'.

As one might expect, different groups with different use cases (e.g. research, quality measurement, clinical decision support) might define these outcomes differently, hampering data reuse.

We seek in this project to define a method and a formalism for representing outcome definitions and criteria, such that the criteria can be reused across different use cases. We propose aligning with the direction the United States is going with quality measurements and decision support, so that a common set of definitions can be used across quality measurement, decision support, research, and patient care; and so that we are better able to extract and use data captured in the process of patient care.

We will start with an example based on content available for depression outcomes including such items as those mentioned above. Other potential examples might include criteria in other expert panel reviewed domains. 

In scope for this project:

[1] Define a reproducible method and a formalism for representing condition outcome definitions and criteria, such that the representations can be reused across different use cases.

[2] Align the formalism with the direction the United States is going with quality measurements and decision support, using FHIR, QI-Core, and CQL.

[3] Demonstrate this process end to end through the development of a set of examples, beginning with Depression.  [The example will be used to demonstrate the use of the Framework and not to ballot the content.]

[4] Publish this process and set of examples in a FHIR Implementation Guide.

---

This FHIR implementation guide will use the US Core profiles. If this FHIR implementation guide is unable to use a US Core profile, we will request approval from the US Realm Steering Committee, and provide the US Realm Steering Committee an approved rationale for deviation in the implementation guide where applicable.

3.b. Project Need

Learning Health Systems are hampered by differences in condition definitions and criteria across quality measurements, decision support, research, and direct patient care. These differences further add to provider data capture burden, and hamper our ability to reuse data generated in the process of patient care.

3.c. Security Risks

Will this project produce executable(s), for example, schemas, transforms, style sheets, executable program, etc.  If so the project must review and document security risks. Refer to the Cookbook for Security Considerations for additional guidance, including sample spreadsheets that may be used to conduct the security risk assessment. 

Yes

x

No

Unknown

3.d. External Drivers

This work is supported by the Office of the Secretary Patient-Centered Outcomes Research Trust Fund under Interagency Agreement 18-596R-18 through Agency for Healthcare Research and Quality contract no. 75Q80119C00005.


3.e. Project Objectives / Deliverables / Target Dates

Within each row, enter the explicit work product(s) / objective(s).  Indicate their target date at the right in WGM/Ballot Cycle format.  Include the project end date as the last objective (for standards projects, the end date will be the projected ANSI approval date). 

Target Date(in WGM or ballot cycle format, e.g.

‘2017 Sept WGM’ or

‘2017 Jan Ballot’)

Comment-Only ballot

  • Connectathon
  • Submit
  • Reconcile
  • Publish
  • May, 2021 connectathon
  • May, 2021 ballot cycle
  • 3 mo to reconcile and publish

STU ballot

  • Connectathon
  • Submit
  • Reconcile
  • Publish
  • Sept, 2021 connectathon
  • Sept, 2021 ballot cycle
  • 6 mo to reconcile and publish
Real world testing and possible additional STU ballot(s)Through Sept, 2022

Normative ballot

  • Connectathon
  • Submit
  • Reconcile
  • Publish
  • Sept, 2022 connectathon
  • Sept, 2022 ballot cycle
  • 6 mo to reconcile and publish

Project End Date (all objectives have been met)

Note:  For PSS-Lite/Investigative Project, End date must be no more than two WGM cycles, e.g. project initiated at January WGM must complete investigation by September WGM.

2023 May



3.f.   Common Names / Keywords / Aliases


Outcome Measures Framework, OMF


3.g. Lineage


NA

3.h. Project Dependencies


QI-Core; CQL; FHIR Library resource


3.i.   HL7-Managed Project Document Repository Location


Projects must adhere to the TSC's guidelines (which were approved on 2016-04-04 and summarized in Appendix A).

A template to create a Project Page on the HL7 Wiki is available at: http://wiki.hl7.org/index.php?title=Template:Project_Page.

Enter the SPECIFIC URL of the HL7-MANAGED SITE where supporting project documents, deliverables, ballot reconciliation work and other project information will be kept
https://confluence.hl7.org/display/CQIWC/Outcome+Criteria+Framework


3.j.   Backwards Compatibility


Are the items being produced by this project backward compatible?

Yes

No

Unknown

x

N/A

If you check 'Yes' please indicate the earliest prior release and/or version to which the compatibility applies:


For V3, are you using the current data types? 

(Refer to TSC position statement on new projects using R2B for more information on the current V3 data types)

Yes

No

Unknown

x

N/A



If you check no, please explain the reason:

If desired, enter additional information regarding Backwards Compatibility.


3.k. External Vocabularies


Will this project include/reference external vocabularies?

x

Yes

No


Unknown

N/A

If Yes, please enter the vocabularies: We currently anticipate at least SNOMED, ICD10CM, LOINC, RxNorm


4. Products (check all that apply)



Arden Syntax


V2 Messages – Administrative


Clinical Information Modeling Initiative (CIMI)


V2 Messages - Clinical


Clinical Context Object Workgroup (CCOW)


V2 Messages - Departmental


Domain Analysis Model (DAM)


V2 Messages – Infrastructure


Electronic Health Record (EHR) Functional Profile


V3 Domain Information Model (DIM / DMIM)


FHIR Extensions


V3 Documents – Administrative (e.g. SPL)

x

FHIR Implementation Guide (enter FHIR product version below)


V3 Documents – Clinical (e.g. CDA)


FHIR Profiles (enter FHIR product version below)


V3 Documents - Knowledge


FHIR Resources


V3 Foundation – RIM


Guidance (e.g. Companion Guide, Cookbook, etc)


V3 Foundation – Vocab Domains & Value Sets


Logical Model


V3 Messages - Administrative


New/Modified/HL7 Policy/Procedure/Process


V3 Messages - Clinical


New Product Definition (please define below)


V3 Messages - Departmental


New Product Family (please define below)


V3 Messages - Infrastructure


Non Product Project - (Educ. Marketing, Elec. Services, etc.)


V3 Rules - GELLO


White Paper


V3 Services – Java Services (ITS Work Group)


Creating/Using a tool not listed in the HL7 Tool Inventory


V3 Services – Web Services (SOA)

If you checked New Product Definition or New Product Family, please define below:


For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

FHIR 4


5. Project Intent (check all that apply)



Create new standard


Supplement to a current standard

Revise current standard (see text box below)


x

Implementation Guide (IG) will be created/modified

Reaffirmation of a standard


Project is adopting/endorsing an externally developed IG:

New/Modified HL7 Policy/Procedure/Process


Specify external organization in Sec. 6 below;





Externally developed IG is to be (select one):


White Paper (select one):


Adopted  - OR -

?

Endorsed


Balloted Informative OR

Non-balloted WG White Paper


N/A  (Project not directly related to an HL7 Standard)











If revising a current standard, indicate the following:


-    Name of the standard being revised:
-    Date it was published (or request for publication, or ANSI designation date)
-    Rationale for revision
-    The relationship between the new standard and the current standard (is it designed to replace the current standard, a supplement to the current standard, etc.)


5.a. Ballot Type (check all that apply)


Comment (aka Comment-Only)


Joint Ballot (with other SDOs)

Informative


N/A  (project won’t go through ballot)

x

STU to Normative     - OR -

Normative (no STU)











If necessary, add any additional ballot information here.  If artifacts will be jointly balloted with other SDOs, list the other groups.



5.b. Joint Copyright

Check this box if you will be pursuing a joint copyright.  Note that when this box is checked, a Joint Copyright Letter of Agreement must be submitted to the TSC in order for the PSS to receive TSC approval.

Joint Copyrighted Material will be produced?


Yes

x

No


6. Project Logistics

6.a. External Project Collaboration


Include SDOs or other external entities you are collaborating with, including government agencies as well as any industry outreach.  Indicate the nature and status of the Memorandum of Understanding (MOU) if applicable.

For projects that have some of their content already developed:

How much content for this project is already developed?

Portions of the examples, but none of the normative content

Was the content externally developed ? :

Y

AHRQ

Is this a hosted (externally funded) project?  (not asking for amount just if funded)

x

Yes

No


6.b. Realm


Universal 

- OR -

 x

Realm Specific



 

Check here if this standard balloted or was previously approved as realm specific standard

U.S.



6.c. Stakeholders / Vendors / Providers

This section must be completed for projects containing items expected to be ANSI approved, as it is an ANSI requirement for all ballots

 

Stakeholders

 

Vendors

 

Providers

 

Clinical and Public Health Laboratories

  

Pharmaceutical

  

Clinical and Public Health Laboratories

  

Immunization Registries

  

EHR, PHR

  

Emergency Services

x  

Quality Reporting Agencies

  

Equipment

  

Local and State Departments of Health

  

Regulatory Agency

  

Health Care IT

  

Medical Imaging Service

  

Standards Development Organizations (SDOs)

 x 

Clinical Decision Support Systems

  

Healthcare Institutions (hospitals, long term care, home care, mental health)

  

Payors

  

Lab

  

Other (specify in text box below)

  

Other (specify in text box below)

  

HIS

  

N/A

  

N/A

  

Other (specify below)


 

 


  

N/A

 

 


Other:  Indicate other stakeholders, vendors or providers not listed above.










6.d. Project Approval Dates

Click here to go to HL7 Project Scope Statement Instructions#Appendix A for more information regarding this section.
Approvals are by simple majority vote of the approving body

Sponsoring Work Group (CQI) Approval Date:

WG Approval Date

2020-04-10; 2020-05-08

Administrative review – in parallel with Work Group Approval

Co-Sponsor Group (CDS) Approval Date


List each Co-Sponsor and their Approval Date

2020-04-29

Family Management Group Approval Date(s)

CIMI Projects: CIMI Management Group

CIMI MG Approval Date

NA

CDA Projects: CDA Management Group

CDA MG Approval Date

NA

FHIR Projects: FHIR Management Group

FMG Approval Date

2020-05-20

V2/Publishing Projects: V2 Management Group

V2 MG Approval Date

NA

US Realm Projects: US Realm Steering Committee Approval
(Email WG approved PSS to: tscpm@HL7.org)

USRSC Approval Date

2020-05-19

Affiliate Specific Projects: Affiliate Approval Date

Affiliate Approval Date

NA

Submit PSS to Steering Division after all of the above approvals are received

Steering Division (of Primary Sponsor WG) Approval Date:

SD Approval Date CCYY-MM-DD

2020-06-17

Last PBS Metrics Score:

 Green

 Yellow

 Red

PBS Metrics Reviewed? (required for SD Approval if not green)

 Yes

 No

ARB and Steering Division approval may be in parallel

Architectural Review Board Approval Date:

(required for externally developed content)

ARB Approval Date

NA (in May 2020, ARB took a motion that there was no external content to review)

TSC Approval

If applicable, TSC has received a Joint Copyright/Distribution Agreement (containing the verbiage outlined within the SOU),
signed by both parties.

Yes

No

 N/A


Technical Steering Committee Approval Date:
(Email SD WG approved PSS to: tscpm@HL7.org)

TSC Approval Date

2020-06-29