Clinical Observations Interoperability: A Use Case Scenario Rachel Richesson, PhD, MPH * University of South Florida College of Medicine Clinical Observations Interoperability Session HCLSIG Face to Face, November 8, 2007 http://esw.w3.org/topic/HCLS/ ClinicalObservationsInteroperability * Acknowledgements to the members of the COI Task Force
19
Embed
Clinical Observations Interoperability: A Use Case Scenario
Clinical Observations Interoperability: A Use Case Scenario. Rachel Richesson, PhD, MPH * University of South Florida College of Medicine Clinical Observations Interoperability Session HCLSIG Face to Face, November 8, 2007 http://esw.w3.org/topic/HCLS/ClinicalObservationsInteroperability - PowerPoint PPT Presentation
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
Clinical Observations Interoperability:A Use Case Scenario
Rachel Richesson, PhD, MPH*
University of South Florida College of MedicineClinical Observations Interoperability Session
* Acknowledgements to the members of the COI Task Force
Outline
• Motivation and Background
• Need
• Use Case Scenario– Eligibility Criteria– Sample Protocols
• Challenges
• Next Steps
Clinical Sites
Toronto,Canada
Paris, France
Edinburgh,UK
Cambridge,UK
Groningen, Netherlands
TokyoJapan
Melbourne,Australia
Sao Paulo,Brazil
Lyon,France
QuebecCanada
Bad Bramstedt,Germany
London
Motivation and Background• Identification & recruitment of eligible subjects is an
obstacle for the conduct of clinical research.
• Current screening mostly manual.
• Unlikely that all of the data required to assess eligibility for a given protocol will be available in the EMR.
• Final eligibility determined by the clinical research staff with F2F assessment.
• Applications that identify likely candidates (“probably eligible”) would help researchers target recruitment efforts.
Need for Patient Recruitment
• Ability to rapidly identify and recruit children for the right Clinical Trial– Children get access to the latest advances in medicine– Clinical researchers get cohorts to conduct studies
• Use Case Scenario:– Can we leverage existing EMR data to identify and
recruit appropriate patients for Clinical Trials?
Use Case
• Patient Recruitment for Clinical Trials using EMR data• Team effort• Several iterations• Final use-case posted to wiki (URL below):
• EMR data-driven triggers– Certain values/clinical scenarios in the EMR data for a patient
would trigger retrieval and analysis of more EMR data
– This could lead to a dynamic identification of the patient as a recruit for an ongoing clinical trial.
• Physician-directed recruitment – Identify appropriate clinical trials for which a patient is eligible,
based on his/her data.
Sample Protocol
Ages Eligible for Study: 18 Years - 95 Years, Genders Eligible for Study: Both
Inclusion Criteria:• Patients will be eligible if they are 18 years of age or older • Fluent in English • Have a known diagnosis of asthma • Will receive treatment for asthma during the current hospitalization or
emergency room visit.
Exclusion Criteria:• Cognitive deficits • Other pulmonary diseases or severe comorbidity • Do not have out-patient access to a telephone
Eligibility Criteria:Based on Sampled RDCRN Eligibility Criteria (n=452) ; Rachel Richesson, Unpublished Data – DO NOT CITE
Constructs Example # %
diagnosis Confirmed diagnosis of PCD. 66 15%
consent Is the subject or legal representative able to give informed consent? 60 13%
finding
Known or suspected PHA (or variant PHA), which might include elevated (or borderline) sweat Cl- values. 54 12%
disease Other disorders of chronic sino-pulmonary disease. 46 10%
condition Intercurrent infection at initiation of study drug. 31 7%
lab Decreased AS enzyme activity in cultured skin fibroblasts or other appropriate tissue. 34 8%
mutation Atypical deletion. 30 7%
logic One of three criteria above is met when other affected family members meet the other two criteria. 26 6%
patient characteristic Age between 1 day and 5 years old. 22 5%
medication High dose folate or derivative within last 12 months/ 19 4%
procedure done Has had liver transplant. 15 3%
Construct Example # %
reproductive potential If female of child bearing potential and sexually active, agrees to use an acceptable method of birth control. 12 3%
study arm Group A: Low Risk. 10 2%
procedure findings An abnormal long exercise CMAP test. 8 2%
administration Sibling with AGS enrolled in study. 6 1%
family history Cardiac : Do any other family members have either cardiac feature? 5 1%