ANNUAL OCT. 31-NOV. 2, 2017 MEETING ARLINGTON, VA Appendectomy vs. Antibiotics The CODA Randomized Trial Larry Kessler, Sc.D. Professor, Department of Health Services, University of Washington CODA Executive Committee Chair @CertainWA November 1 st , 2017 #PCORI2017
ANNUAL MEETING | #PCORI2017 Larry Kessler • Has nothing to disclose. November 5, 2017 2
ANNUAL MEETING | #PCORI2017 Objectives At the conclusion of this activity, the participant should be able to: • Objective 1: understand the rationale for a trial comparing antibiotics vs. surgery for appendicitis • Objective 2: explain the design of the CODA study • Objective 3: understand the concerns of CODA investigators about the PCORI Open Science Pilot Project November 5, 2017 3
ANNUAL MEETING | #PCORI2017 CODA: We asked patients what they thought • Using focus groups, social media and sourced-based surveying • Interviews with patients who had appendicitis and were deciding about treatment • Input of 809 respondents November 5, 2017 4
ANNUAL MEETING | #PCORI2017 CODA: Primary Study Questions Are antibiotics as effective as appendectomy for appendicitis? Which patients are most likely to have a successful outcome with antibiotics-first? November 5, 2017 5
ANNUAL MEETING | #PCORI2017 CODA Study Design • Randomized-controlled trial ─ Large-scale (n=1,552) ─ Non-inferiority based • Antibiotics “just as good as” appendectomy ─ Pragmatic • Routine clinical practice settings, heterogeneous population • Parallel observational cohort (n=500) • 18 sites nationwide November 5, 2017 6
ANNUAL MEETING | #PCORI2017 November 5, 2017 7
ANNUAL MEETING | #PCORI2017 Key Governance Challenges in Data Sharing • 18 sites and their investigators – will want first access • CODA timeline – recruitment ends 2019; follow up ends December 2021 with CODA-investigator analysis approximately though 2021. Data not ready until 2022/3 • For what purpose would data be shared outside the original investigators? • To serve the wider scientific community for verification of results • To produce additional scientific inquiry • To address questions from other interested parties, e.g., patients, advocacy organizations • Commerc rcial i intere rests • Litigation • CODA i inves estigators c concer erned ed about t the l e latter er two November 5, 2017 8
ANNUAL MEETING | #PCORI2017 Key Governance Challenges in Data Sharing • Who should be given access? Qualifications? • Scientific review of request? Criteria for rejection? • How will specific aims that change after the original data request be handled? • Central repository or from the original investigators only? • Continuing role of the original investigators? • Questions will be asked of the data that only they will know • Communication about requests to the public and scientific community? November 5, 2017 9
ANNUAL MEETING | #PCORI2017 Learn More • www.pcori.org • info@pcori.org • #PCORI2017 • www.codastudy.org November 5, 2017 10
ANNUAL MEETING | #PCORI2017 Questions? November 5, 2017 11
ANNUAL MEETING | #PCORI2017 Thank You! Larry Kessler, Sc.D. Professor, Department of Health Services, University of Washington CODA Executive Committee Chair @CertainWA November 1 st , 2017 November 5, 2017 12
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