1. Copyright© 2010 Continua Health Alliance ® All Rights Reserved Continua Health Alliance and HL-7 Result of the workshop with Lantana on investigating the options for Questionnaire Standardization Asim Muhammad (Philips, Chair E2E Architecture) Martin Rosner (Philips, Chair E2E Security ) Confidential Information

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

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

4. | WAN-Interface Application Hosting Device WAN Device (hosts telehealth services) Future (2013): Enable questionnaires and questionnaire response Continua E2E Reference Topology (with real-world example devices overlayed) Current state: Observations upload based on IHE PCD 01-HL7 v2.6 and WS-I basic profile IHE XDR + HL7 CDA R2 Consent Directive IG

5. | Questionnaire use case WAN Device Application Hosting Device Questionnaire document (inc. branching logic) Questionnaire Response document 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. Patient fills-in the questionnaire Out of scope for Continua

6. | Question Set 1 Question Set –It groups questions related to a domain e.g. mental well-being. Confidential Information Element (or Attribute) DefinitionMultiplicity Question Set IDThis 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. [1..1] QuestionsThese are the actual questions which may be asked and are organized within the Question Set 1 [1..*]

7. | Question 1 Element (or Attribute) DefinitionMultiplicity Question IDThis 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 A1The same as last week [1..n] A2Better than last week A3Worse than last week Question type Indicates the type of question. In this example the type of question is Multiple Choice. [1..1] SkipIndicates 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]

8. | Question 2 Element (or Attribute) DefinitionMultiplicity Question IDThis uniquely identifies a question within a Questionnaire document.[1..1] Question text Compared to last week, please rate your breathlessness. [1..1] Answer options B1B1The same as last week [1..n] B2B2Better than last week B3Worse than last week Question type Indicates the type of question. In this example the type of question is Multiple Choice. [1..1] SkipIndicates 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]

9. | Question 3 Element (or Attribute) DefinitionMultiplicity Question IDThis 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 A3 AND answer to Question 2 is B3. [0..1] Question text Why do you feel worse? [1..1] Answer Answer could be I didnt drink coffee. [1..n] Question type Indicates the type of question. In this example, the type of question is Free Text. [1..1] SkipIndicates 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]

10. | 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 ObservationRange construct) Confidential Information Element (or Attribute) DefinitionMultiplicity Question IDThis 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 A1The same as last week [1..n] A2Better than last week A3Worse than last week Question type Indicates the type of question. In this example the type of question is Multiple Choice. [1..1] Min. of AnswersIndicates the minimum number of answer options a patient should select.[0..1] Max. of AnswersIndicates the maximum number of answer options a patient should select.[0..1] Multimedia item Reference to a multimedia item that needs to be rendered simultaneous with the question text. [0..1] SkipIndicates 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] Additional elements to Question 1 (slide 7)

11. | Additional requirements (2/2) Confidential Information Element (or Attribute) DefinitionMultiplicity Question IDThis 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 Indicates the type of question. In this example the type of question is numeric. [1..1] Low valueUsed to indicate the low boundary e.g. 0[0..1] High valueUsed to indicate the low boundary e.g. 24[0..1] SkipIndicates 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] 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 ObservationRange construct.

12. | 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

13. | Options As a result of the three day workshop we identified the following options for expressing the Questionnaire Document in a standard format Options Confidential Information CDA with extensions Could use moodCode=DEF for defining questions derivationExpr 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.

14. | 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

15. | 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

16. | 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 F2F meeting Confidential Information