Form Definition and Questionnaire Response Documents

Form Definition and Questionnaire Response Documents

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Project Overview

This project will define a specification for the structured representation of a Form Definition and Questionnaire Response documents focusing initially on the requirements presented by the Continua Health Alliance Questionnaire Use Case. The specification will leverage HL7 CDA base standard and derived implementation guides.

In the context of remotely monitoring patients, there is a need to facilitate the exchange of questionnaires between practitioners and patients. Electronic interchange of patients’ vital signs to the monitoring service or medical practitioner is but the first step in enabling effective dialogue and health practice. Of equal importance is the electronic interchange of meaningful questions and answers between the practitioner and the patient. The Continua Health Alliance is recognizing this need and has identified the following main areas for the meaningful exchange of the questions and answers:

• structured Form Definition Document representation.
• structured Questionnaire Response Document representation

Our approach here is to represent the Questionnaires and Responses in a structured document by reusing and/or enhancing existing CDA templates where possible while creating new CDA templates where necessary.

Project Facilitators

The Form Definition and Questionnaire Response Documents project team comprises of the following project facilitators:

• Martin Rosner
• Brian Reinhold

Participants

Martin Rosner (Philips), Brian Scheller (Healthwise), Vin Sekar (National E-Health Transition Authority), Asim Muhammad (Philips), Vinayak Kulkarni (Siemens), Rick Geimer (Lantana), Stephen Chu (National E-Health Transition Authority). Lisa Nelson (Life Over Time Solutions) Lisa Brooks Taylor (AHIMA) Jessi Formoe (Intuit)

Project Meetings

No regular meetings scheduled at the moment.

Project Documents

The project documentation is provided below.

Project Scope Statements

• Structured Form Definition PSS (approvals -> WG: 2013-01-14; SD: 2013-Week8; TSC: 2013-Week9)
• Questionnaire Response PSS (approvals -> WG: 2013-01-15; SD: 2013-Week8; TSC: 2013-Week9)

Notice of Intent to Ballot

• Structured Form Definition NIB (submitted 2013-02-14)
• Questionnaire Response NIB (submitted 2013-02-14)

Meeting Minutes

• June 18, 2013
• June 11, 2013
• June 4, 2013
• May 28, 2013
• May 21, 2013
• May 14, 2013
• March 26, 2013
• March 21, 2013
• March 19, 2013
• March 12, 2013
• March 7, 2013
• March 5, 2013
• February 28, 2013
• February 26, 2013
• February 19, 2013
• February 12, 2013
• February 5, 2013
• January 28, 2013

Current IG Drafts

• Current draft of Form Definition IG - 03/26/2013
• Current draft of Questionnaire Response IG - 03/26/2013

Current XML Sample Drafts

• Current XML sample (.zip) for Form Definition - 03/26/2013
• Current XML sample (.zip) for Questionnaire Response - 03/26/2013

Ballot Packages - April 2013 Ballot

• Form Definition Package(.zip) - 03/28/2013
• Questionnaire Response Package (.zip) - 03/28/2013

Ballot Results

Voting Results

Ballot Number	Name	Ballot Level and Iteration	Affirmative Votes	Negative Votes	Abstains	No Vote Returned	Total Pool Size	Quorum	Affirmatives Needed
9	HL7 Implementation Guide for CDA® Release 2: Questionnaire Response Document, Release 1	D1	29	11	92	28	160	82.50%	24
10	HL7 Implementation Guide for CDA® Release 2: Structured Form Definition Document, Release 1	D1	28	7	92	28	155	81.94%	21

Comments Summary

Ballot Number	Name	Neg-Mj	Neg-Mi	A-T	A-S	A-Q	A-C	<blank>	Total	In person resolution requested by
9	HL7 Implementation Guide for CDA® Release 2: Questionnaire Response Document, Release 1	12	17	22	29	10	5	0	95	Gaye Dolin (rick.gaimer@lantana.com), Lisa Nelson, Benjamin Flessner
10	HL7 Implementation Guide for CDA® Release 2: Structured Form Definition Document, Release 1	8	10	8	17	7	18	4	72	Lisa Nelson, Benjamin Flessner

Ballot Reconciliation

Disposition Approval

Structured Form Definition (SFD)	Questionnaire Response (QR)
SFD Comments - before SDWG F2F Meeting in Atlanta - May 2013	QR Comments - before SDWG F2F Meeting in Atlanta - May 2013
SFD Comments - after SDWG F2F Meeting in Atlanta - May 2013	QR Comments - after SDWG F2F Meeting in Atlanta - May 2013
SFD May 14 Project Call
SFD May 21 Project Call
SFD May 23 SDWG Call Block Vote: Bvote - May232013
SFD May 28 Project Call	QR May 28 Project Call
SFD May 30 SDWG Call Block Vote: Bvote - May302013
SFD June 4 Project Call	QR June 4 Project Call
SFD June 6 SDWG Call Block Vote: Bvote - June062013	QR June 6 SDWG Call Block Vote: Bvote - June062013
SFD June 11 Project Call	QR June 11 Project Call
SFD June 13 SDWG Call Block Vote: Bvote - June132013	QR June 13 SDWG Call Block Vote: Bvote - June132013
SFD June 18 Project Call	QR June 18 Project Call
June 20 block vote for SFD postponed to June 27	QR June 20 SDWG Call Block Vote: Bvote - June202013
SFD June 27 SDWG Call Block Vote: Bvote - June272013 - SDWG approved full ballot reconciliation spreadsheet on Aug. 15, 2013	QR Aug 15 SDWG Call Vote on last comment: last comment - Aug152013 - SDWG approved full ballot reconciliation spreadsheet on Aug. 15, 2013
SFD October 10 SDWG Call Vote on re-opened comment #13: Re-opened Vote - Oct102013 - SDWG re-opened and approved one comment in the approved (Approved Aug.15) full ballot reconciliation spreadsheet on Oct. 10, 2013	QR October 10 SDWG Call Vote on re-opened comment #22: Re-opened Vote - Oct102013 - SDWG re-opened and approved one comment in the approved (Approved Aug.15) full ballot reconciliation spreadsheet on Oct. 10, 2013

Disposition Implementation

Structured Form Definition (SFD)	Questionnaire Response (QR)
SFD Resolved Package - Ready for SDWG review - October 2013 - http://www.hl7.org/documentcenter/public/wg/structure/CDAR2_IG_SFDEFDOC_R1_D1_2013APR_RES_10102013.zip	QR Resolved Package - Ready for SDWG review - October 2013 - http://www.hl7.org/documentcenter/public/wg/structure/CDAR2_IG_QRDOC_R1_D1_2013MAY_Dispositions_(version_10_October_2013).zip

Publication Prep

Publication Request Forms

Questionnaire Form Definition (QFD)	Questionnaire Response (QR)
QFD Publication Request Form	QR Publication Request Form

STU Comment Period

The STU period started on February 1, 2014 and will end on February 1, 2016. Review and comments can be performed via the links below.

Links to STU pages

Questionnaire Form Definition (QFD)	Questionnaire Response (QR)
http://www.hl7.org/dstucomments/showdetail.cfm?dstuid=116	http://www.hl7.org/dstucomments/showdetail.cfm?dstuid=117

Getting to Normative 1

As of August 2016, the STU period for both IGs has been extended and it is time to ballot towards Normative.

2016 NIBs towards Normative 1

Questionnaire Form Definition (QFD)	Questionnaire Response (QR)
QFD Normative 1 NIB	QR Normative 1 NIB

Normative Ballot Packages - January 2017 Ballot

Pre-submission review versions

• Questionnaire Form Definition Package(.zip) - 11/22/2016
• Questionnaire Response Package (.zip) - 11/22/2016

Submitted versions

• Questionnaire Form Definition Package(.zip) - 12/02/2016
• Questionnaire Response Package (.zip) - 12/02/2016

Normative Ballot Results - N1 - January 2017 Ballot

Voting Results

Name	Ballot Level and Iteration	Affirmative Votes	Negative Votes	Abstains	No Vote Returned	Total Pool Size	Quorum	Affirmatives Needed
HL7 CDA® R2 Implementation Guide: Questionnaire Response Document, Release 1 (PI ID: 977)	N1	64	8	67	23	162	85.8%	54
HL7 CDA® R2 Implementation Guide: Structured Form Definition Document, Release 1 (PI ID: 976)	N1	59	9	50	21	139	84.89%	51

Amalgamated Ballot Spreadsheets

• Questionnaire Form Definition
• Questionnaire Response

Normative Ballot (N1) Reconciliation

Ballot Reconciliation Meeting Minutes

• February 6, 2017 minutes and resulting ballot sheet for Form Definition
• February 13, 2017 minutes - Cancelled
• February 20, 2017 minutes and resulting ballot sheet for Form Definition
• March 13, 2017 minutes and resulting ballot sheet for Form Definition
• April 3, 2017 minutes and resulting ballot sheet for Form Definition
• April 24, 2017 minutes and resulting ballot sheet for Questionnaire Response
• May 15, 2017 minutes and resulting ballot sheet for Questionnaire Response
• June 5, 2017 minutes and resulting ballot sheet for Questionnaire Response
• June 12, 2017 minutes and resulting ballot sheet for Questionnaire Response
• June 19, 2017 minutes and resulting ballot sheet for Questionnaire Response
• June 26, 2017 minutes and resulting ballot sheet for Questionnaire Response
• July 10, 2017 minutes and resulting ballot sheet for Form Definition

Structured Documents Working Group Review / Approval

• Block Vote 1 for Structured Form Definition (SFD) and Questionnaire Response (QR) submitted to SDWG on August 4, 2017. SFD block vote BV1 was approved by SDWG during the Aug.10.2017 conference call (opp-0; abs-0; for-23). QR block vote BV1 was approved by SDWG during the Aug.10.2017 conference call (opp-0; abs-0; for-24).

• Block Vote 2 for Structured Form Definition (SFD) and Questionnaire Response (QR) submitted to SDWG on August 11, 2017. SFD block vote BV2 was approved by SDWG during the Aug.17.2017 conference call (opp-0; abs-4; for-19). QR block vote BV2 was approved by SDWG during the Aug.17.2017 conference call (opp-0; abs-5; for-18).

• Block Vote 3 for Structured Form Definition (SFD) and Questionnaire Response (QR) submitted to SDWG on October 30, 2017. SFD block vote BV3 was approved by SDWG during the Nov.09.2017 conference call (opp-0; abs-2; for-21). QR block vote BV3 was approved by SDWG during the Nov.09.2017 conference call (opp-0; abs-2; for-21).

• Full ballot reconciliation spreadsheets for Structured Form Definition (SFD) and Questionnaire Response (QR) submitted to SDWG for approval on January 4, 2018. Approved by SDWG during the Jan.11.2018 conference call (opp-0; abs-1; for-22).

• The final approved ballot reconciliation spreadsheets with substantive changes marked for Structured Form Definition (SFD) and Questionnaire Response (QR).

Getting to Normative 2

Ballot reconciliation for the Normative 1 ballot is resulting in substantive changes. As such, corresponding modifications will require a re-ballot. The following are draft NIBs for the May 2017 ballot.

UPDATE (June 2017): this second Normative ballot was postponed as the content from previous ballot (N1) has not yet been updated based on the comment resolution from N1 ballot that took place on Jan. 2017.

UPDATE (October 2018): The ballot reconciliation spreadsheet with comments from the last (N1 in Jan of 2017) ballot has been approved in Jan. 2018. While the spreadsheet has been approved, the implementation of the resolutions has stalled due to resource constraints from Personal Connected Health Alliance (PCHA). Recently, PCHA has allocated resources to finalize this work and implement the comment resolutions towards a new ballot (N2). This implementation guide (STU version) is already profiled by the guidelines developed by the PCHA, but needs to be finalized as Normative to fully be adopted by the PCHA guidelines.

UPDATE (February 2019) We are working towards submitting both IGs as N2 normative ballot in April.

UPDATE (May 2019) We decided to only ballot the Questionnaire Response and delay the Form Definition IG until the precondition extension issue is resolved.

UPDATE (June 2019) The QFD precondition extension was discussed during the Montreal F2F meeting. The current proposal was reviewed and accepted. See meeting notes: https://confluence.hl7.org/display/SD/SD+WGM+May+%2719+Wed+Q3+Minutes

NIBs towards Normative 2

Questionnaire Form Definition (QFD)	Questionnaire Response (QR)
QFD Normative 2 NIB	QR Normative 2 NIB
QFD Normative 2 NIB (voted and approved on 02/14/2019 CDWG call with 0-0-22 vote)	(Latest) QR Normative 2 NIB (voted and approved on 02/14/2019 CDWG call with 0-0-22 vote)
(this ballot never happened as there was a need to fix the precondition extension) QFD Normative 2 NIB for the Sept. 2019 ballot (voted and approved on 06/20/2019 CDWG call with 0-0-24 vote)	ballot postponed
(Latest) QFD Normative 2 NIB for the Sept. 2019 ballot (voted on SDWG Nov.7.2019 telco (opp-0; abs-0; for-19))	(Latest) QR Normative 2 NIB for the Sept. 2019 ballot (voted on SDWG Nov.7.2019 telco (opp-0; abs-0; for-19))

Normative Ballot Results - N2 - May 2019 Ballot Voting Results

Name	Ballot Level and Iteration	Affirmative Votes	Negative Votes	Abstains	No Vote Returned	Total Pool Size	Quorum	Affirmatives Needed
HL7 CDA® R2 Implementation Guide: Questionnaire Response Document, Release 1 (PI ID: 977)	N2	46	4	84	27	161	83.23%	38
HL7 CDA® R2 Implementation Guide: Structured Form Definition Document, Release 1 (PI ID: 976) (not yet balloted)

Ballot Reconciliation Worksheets

Questionnaire Form Definition (QFD)	Questionnaire Response (QR)
QFD Approved by SDWG during the Jan.11.2018 conference call (opp-0; abs-1; for-22). See above.	QR Normative 2 Amalgamated Worksheet
QFD Approved by SDWG during the Jan.11.2018 conference call (opp-0; abs-1; for-22). See above.	QR Normative 2 Final Ballot Reconciliation Worksheet (voted on SDWG Nov.7.2019 telco (opp-0; abs-0; for-19))

Structured Documents Working Group Review / Approval

• Block Vote 1 for Questionnaire Response (QR) submitted to SDWG on Sept 27, 2019. QR block vote BV1 was approved by SDWG during the Oct.3.2019 conference call (opp-0; abs-0; for-14).
• Block Vote 2 for Questionnaire Response (QR) submitted to SDWG on Oct 4, 2019. QR block vote BV2 was approved by SDWG during the Oct.10.2019 conference call (opp-0; abs-0; for-24).
• Vote to go to Jan 2020 ballot for both documents submitted to SDWG on Dec. 11, 2019 and approved by the SDWG to go to ballot during the Dec.19.2019 conference call (opp-0; abs-0; for 17).