Continua Health Alliance and HL7 Result of the

Continua Health Alliance and HL-7 Result of the workshop with Lantana on investigating the options for Questionnaire Standardization Asim Muhammad (Philips, Chair E 2 E Architecture) Martin Rosner (Philips, Chair E 2 E Security ) Confidential Information Copyright© 2010 Continua Health Alliance ® All Rights Reserved

Outline • Continua Questionnaire Use Case • Sample Questions • Workshop with Lantana on the Realization of Continua Requirements – Options – Results • Discussion and next steps |

Current Architecture and Enhancements Application Hosting Device Personal Device (PAN/LAN/TAN) HRN Device WAN Device Thermometer Pulse Oximeter CCD Pulse / Blood Pressure PCD 01 Weight Scale NFC Glucose Meter Cardio / Strength Peak Flow Low Energy Adherence Monitor Independent Living Activity Water Gas Temperature Fall Wide Area Network (WAN) Interface Health Reporting Network (HRN) Interface EHR HIE PHR NHIN | Device Connectivity 3

Continua E 2 E Reference Topology (with real-world example devices overlayed) Application Hosting Device Current state: • Observations upload based on IHE PCD 01 -HL 7 v 2. 6 and WS-I basic profile • IHE XDR + HL 7 CDA R 2 Consent Directive IG WAN-Interface Future (2013): Enable questionnaires and questionnaire response | WAN Device (hosts telehealth services)

Questionnaire use case Questionnaire document (inc. branching logic) Out of scope for Continua Application Hosting Device Out of scope for Continua Questionnaire Response document WAN Device Patient fills-in the questionnaire The objective is to enable the interoperable representation and exchange of the questionnaire and questionnaire response across the WAN-IF. Defining the rendering / layout (XHTML, XForm etc. ) of the questionnaire on the AHD is an implementer responsibility and out of |scope for Continua.

Question Set 1 • Question Set – It groups questions related to a domain e. g. mental well-being. Element (or Attribute) Definition Multiplicity Question Set ID This uniquely identifies a question set within a Questionnaire document. [1. . 1] Question Set Title This is the title of the question set. For example, “Questions related to mental well-being”. These are the actual questions which may be asked and are organized within the Question Set 1 [1. . 1] Questions | Confidential Information [1. . *]

Question 1 Element (or Attribute) Definition Multiplicity Question ID This uniquely identifies a question within the Questionnaire document. [1. . 1] Question text “Compared to last week, how would you rate your health status in general? ” A 1 The same as last week A 2 Better than last week A 3 Worse than last week Indicates the type of question. In this example the type of question is “Multiple Choice”. Indicates whether it is allowed to skip this question (Skip=TRUE) or not (Skip=FALSE). By default the value of Skip could be “FALSE”. [1. . 1] Answer options Question type Skip | [2. . n] [1. . 1] [0. . 1]

Question 2 Element (or Attribute) Definition Multiplicity Question ID This uniquely identifies a question within a Questionnaire document. [1. . 1] Question text “Compared to last week, please rate your breathlessness. ” [1. . 1] Answer options Question type Skip | B 1 The same as last week B 2 Better than last week B 3 Worse than last week Indicates the type of question. In this example the type of question is “Multiple Choice”. Indicates whether it is allowed to skip this question (Skip=TRUE) or not (Skip=FALSE). By default the value of Skip could be “FALSE”. [2. . n] [1. . 1] [0. . 1]

Question 3 Element (or Attribute) Definition Multiplicity Question ID This uniquely identifies a question within a Questionnaire document. [1. . 1] Pre condition This element holds the logical expression. For example, Ask this question ONLY if answer to “Question 1” is “A 3” AND answer to “Question 2” is “B 3”. “Why do you feel worse? ” Answer could be “I didn’t drink coffee ”. Indicates the type of question. In this example, the type of question is “Free Text”. Indicates whether it is allowed to skip this question (Skip=TRUE) or not (Skip=FALSE). By default the value of Skip could be “FALSE”. [0. . 1] Question text Answer Question type Skip | [1. . 1] [1. . n] [1. . 1] [0. . 1]

Additional requirements (1/2) • • A question may also hold link to a multimedia item (e. g. image, video) A question may also consists of attributes that are used to signal the minimum and maximum number of answer option a patient must select (similar to Observation. Range construct) Additional elements to Question 1 (slide 7) Element (or Attribute) Definition Multiplicity Question ID This uniquely identifies a question within the Questionnaire document. [1. . 1] Question text “Compared to last week, how would you rate your health status in general? ” [1. . 1] Answer options A 1 The same as last week A 2 Better than last week A 3 Worse than last week Indicates the type of question. In this example the type of question is “Multiple Choice”. Indicates the minimum number of answer options a patient should select. [1. . n] Indicates the maximum number of answer options a patient should select. Reference to a multimedia item that needs to be rendered simultaneous with the question text. Indicates whether it is allowed to skip this question (Skip=TRUE) or not (Skip=FALSE). By default the value of Skip could be “FALSE”. [0. . 1] Question type Min. of Answers Max. of Answers Multimedia item Skip | Confidential Information [1. . 1] [0. . 1]

Additional requirements (2/2) • The answer to a question may be of numeric type. • Allowed range of values (e. g. 0 to 24) for an answer can be indicated using the Observation. Range construct. Element (or Attribute) Definition Multiplicity Question ID This uniquely identifies a question within the Questionnaire document. [1. . 1] Question text “How many hour do you sleep on average during the night? ” [1. . 1] Answer [1. . 1] Question type Low value High value Skip | Indicates the type of question. In this example the type of question is “numeric”. Used to indicate the low boundary e. g. “ 0” [1. . 1] Used to indicate the low boundary e. g. “ 24” Indicates whether it is allowed to skip this question (Skip=TRUE) or not (Skip=FALSE). By default the value of Skip could be “FALSE”. [0. . 1] Confidential Information [0. . 1]

Workshop with Lantana • Three day workshop with Lantana development team where we discussed Continua use case and requirements (slide 6 -10) and then developed a small prototype. • After several hours of discussion we agreed to focus on the following system diagram: | Confidential Information

Options • As a result of the three day workshop we identified the following options for expressing the Questionnaire Document in a standard format • Options CDA with extensions Could use mood. Code=”DEF” for defining questions derivation. Expr for holding the conditional logic custom extensions to transmit value sets (answer options) in IHE SVS (Sharing Value Sets) XML markup Update to HQMF Questions would be expressed as criteria Could modify the standard to define how a CDA document can be generated in response to criteria. This would benefit QRDA implementation as well as addressing questionnaire logic Need to address what, if any “populations” would be defined in a Continua questionnaire Template formalism? If this type of questionnaires are a collection of templates with conditional logic, then perhaps all we really need is a balloted template formalism (aka a wire format for templates) where templates encompass conditional logic Mash-up of all the above? Take bits of CDA, HQMF, template formalisms, etc. and build a new standard. | Confidential Information

Results (Questionnaire Document) • NOT a clinical document, used to extract the input from patient resulting in a response document • Extended the Questionnaire Assessment templates • If we go with CDA Extension option, then – – – Observation/code holds the question text Observation/value holds the answer option(s) Answer may be constrained as free text, an integer or multiple-choice expressed as a coded value set • Some questions include logic (pre condition- slide 9) that determines what question is shown next depending on the answer(s) to previous questions. – HL-7 Example • If observation/value in template A is “X-SOME-CODE” from LOINC, then template B is required – Continua equivalence • If the user answers question A with “SOME ANSWER”, then show question B next – We also looked at the HQMF IG • can be used to realize logical expressions (ex. a pre condition on slide 9) | Confidential Information

Results (Questionnaire Response) • We agreed that Questionnaire Response is a clinical document and can be easily mapped to CDA constructs similar to Questionnaire Assessment IG. | Confidential Information

Discussion and Next Steps • Feedback on the options – ? • Project scope statement(s) – Draft PSS(s) for Questionnaire and Questionnaire Response work items – Send draft statements to SDWG by Monday the 17 th of Dec. – Review and address comments up until F 2 F meeting | Confidential Information

Copyright© 2010 Continua Health Alliance ® All Rights Reserved

Would require extension to accommodate logical expression i. e. AND, OR (a precondition with multiple criterion or multiple preconditions). See slid 20 -22 for RIM related info. |

From the CDA Hierarchical Descriptor No 357 358 359 360 361 362 363 364 Element Name Card Mand Conf Rim Source precondition type. Code criterion class. Code mood. Code code text value | 0. . * 1. . 1 0. . 1 M M M R R R Act. Relationship Act Act Act Observation Confidential Information of Message Element Type SET<Precondition> CS Criterion CS CS CD ED ANY Src. Domain N D D D PRCN OBS EVN. CRT Act. Code CS Abst Nt CNE CNE CWE Default: PRCN Default: OBS Default: EVN. CRT

HL 7 RIM (1/3) | Confidential Information

HL 7 RIM (2/3) | Confidential Information

HL 7 RIM (3/3) | Confidential Information