Secure Exchange of Clinical Information for Clinical Research. Using open source technology

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Laurel Lawrence
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1 Secure Exchange of Clinical Information for Clinical Research Using open source technology

2 TRANSCEND goals 1. Demonstrate the use of web-based case report forms (CRFs) to facilitate data collection and transmission to NCI. 2. Demonstrate the use of clinically based data collection in support of case report form generation in the I-SPY trial. 3. Demonstrate the integration of an electronic health record system (Tolven echr) with an established translational research infrastructure currently in place for the I-SPY trial. 4. Demonstrate the use of cabig standards in the integration of a clinical care system with other cabig tools (caintegrator, catissue). 5. Develop a general approach utilizing cabig standards for data elements, controlled vocabularies, and system interfaces in constructing a translational research platform spanning genomic/proteomic, radiographic, and clinical data. 6. Evaluate the effectiveness of the TRANSCEND infrastructure in collecting high quality (complete, correct, timely) structured phenotypic data for the I-SPY trial.

Demonstrate the integration of an electronic health record system (Tolven echr) with an established translational research infrastructure currently in place for the I-SPY trial. 4.

3 Trial sites

4 Leveraging Tolven technology for TRANSCEND The Tolven account structure A layer of the Tolven security structure The basis for secure sharing of information Tolven informatics foundation HL7 RIM Standard terminologies Terminology specializations/extensions The Tolven Rules environment Harvesting and de-identifying clinical data for clinical research

informatics foundation HL7 RIM Standard terminologies Terminology

5 Health information is created in many locations Ancillary Services Pharmacy Pager Laboratory Systems Pharmacy Systems Physician Office EMR Systems Acute Care Hospital EMR Systems Phone Emergency Care Wireless Emergency Care System Community Health Systems Patients and Families Personal Health Record Community Clinic

Care Hospital EMR Systems Phone Emergency Care Wireless Emergency Care System

6 Many accounts for many groups of users Physician Office Home Care Social Service Clinical Research Emergency Community Clinic Personal Health Record Hospital

7 Separation between accounts is absolute Physician Office Home Care Social Service Clinical Research Emergency Community Clinic Personal Health Record Hospital

8 Explicit copying for information sharing Physician Office Home Care Social Service Clinical Research Emergency Community Clinic Personal Health Record Hospital

9 Interacting with outside systems Pharmacy Imaging HIE Physician Office Home Care Social Service Clinical Research Laboratory Emergency Community Clinic Personal Health Record Hospital

10 Extending for TRANSCEND Participating cancer care centers utilize a separate cross-institution research account within a Tolven environment Research HIE Physician Office Home Care Social Service Day Surgery Clinical Research Emergency Community Clinic Personal Health Record Long Term Care Hospital

Research HIE Physician Office Home Care Social Service Day Surgery

11 Account boundaries in TRANSCEND Non Tolven Apps ecare CRF CDR Other ISPY Apps Pooled Study Data

12 Creating and transforming data Analyze the paper form Break down the data entry Establish the informatics foundation Create the data entry wizard for clinical care Refine the data for CRF data entry Embed the algorithms for transformation Establish the rules for processing after wizard submission

for clinical care Refine the data for CRF data entry Embed the algorithms

13 Portion of the On-Study form MENOPAUSAL STATUS (Mark one with an X.) Premenopausal (< 6 months since LMP AND no prior bilateral ovariectomy AND not on estrogen replacement) Perimenopausal (6 12 months since LMP AND no prior bilateral ovariectomy AND not on estrogen replacement) Postmenopausal (prior bilateral ovariectomy OR > 12 months since LMP with no prior hysterectomy) Above categories not applicable AND Age < 50 Above categories not applicable AND Age > 50

Perimenopausal (6 12 months since LMP AND no prior bilateral ovariectomy AND not on estrogen replacement)

14 Creating the data Patient s birth date (SCT date of birth): the application supports day/mo/year format a. Day/mo/year 2. When was the patient s last menstrual period? (fuzzy dates are accepted but the application supports day/mo/year format as well:c date of last menstrual period) a. Day/mo/year

15 Creating the data Is the patient on estrogen replacement therapy? (SCT hormone replacement therapy) Default is no a. yes no b. If yes, then display the following: How long has the patient been on estrogen replacement therapy? C duration) i. months ii. years

(SCT266717002 hormone replacement therapy) Default is no a. yes no b.

16 Creating the data Has the patient had bilateral oophorectomy? (SCT bilateral oophorectomy)? Default is no a. yes no b. If yes, then display the following: When was the oophorectomy performed? (fuzzy dates are accepted but the application supports day/mo/year format as well) i. Day/mo/year

If yes, then display the following: When was the oophorectomy performed?

17 Creating the data Has the patient had a hysterectomy? (SCT hysterectomy) Default is no a. yes no b. If yes, then display the following: When was the hysterectomy performed? (fuzzy dates are accepted but the application supports day/mo/year format as well) i. Day/mo/year

If yes, then display the following: When was the hysterectomy performed?

18 Using the algorithms - 1 To determine if the patient fits into the first category (called premenopausal SCT ), we check for the following: Time between now and time of last menstrual period is <6 months Answer to #3 is no Answer to #4 is no If all three criteria are met, then the first box is checked

Time between now and time of last menstrual period is <6 months Answer to #3

19 Using the algorithms - 2 To determine if the patient fits into the second category (called perimenopausal SCT ), we check for the following: Time between now and time of last menstrual period is >6 or =6 and =12 or <12 months Answer to #3 is no Answer to #4 is no If all three criteria are met, then the second box is checked.

and time of last menstrual period is >6 or =6 and =12 or <12 months Answer to #3 is

20 Using the algorithms - 3 To determine if the patient fits into the third category (called postmenopausal SCT ), we check the following: Answer to # 4 is yes or Time between now and time of last menstrual period is >12 months and answer to #5 is no If either criterion is met, then the third box is checked

to # 4 is yes or Time between now and time of last menstrual period is >12

21 Using the algorithms - 4 To determine if the patient fits into the fourth category, we only deal with patients who have not met the criteria for categories 1-3 and then check to see whether now minus date of birth <50. If that is true, then the fourth box is checked. To determine if the patient fits into the fifth category, we only deal with patients who have not met the criteria for categories 1-3 and then check to see whether now minus date of birth >50 or =50. If that is true, then the fifth box is checked.

22 Creating the wizard - 1

23 Creating the wizard - 2

24 Creating the wizard - 3

25 Submitting the data

26 TRANSCEND: summary The TRANSCEND (TRANslational Informatics System to Coordinate Emerging Biomarkers, Novel Agents, and Clinical Data) project provides a blueprint for bridging the gap between clinical research information, and clinical care information. TRANSCEND has achieved several key objectives in that it demonstrates the use of durable health information standards to create interoperable clinical care data in an open source clinical record system and to automatically transform and de-identify that clinically-driven data for use in a collaborative research repository and for reporting to federal agencies regulating and funding that research activity.

27 Thanks! Tom Jones, MD CEO, Tolven For further information:

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