Appendectomy vs. Antibiotics The CODA Randomized Trial Larry - - PowerPoint PPT Presentation

ANNUAL MEETING

• OCT. 31-NOV. 2, 2017

ARLINGTON, VA

#PCORI2017

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 1st, 2017

ANNUAL MEETING | #PCORI2017

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Larry Kessler

• Has nothing to disclose.

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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

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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

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CODA: Primary Study Questions

Are antibiotics as effective as appendectomy for appendicitis? Which patients are most likely to have a successful

• utcome with antibiotics-first?

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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

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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
• rganizations
• Commerc

rcial i intere rests

• Litigation
• CODA i

inves estigators c concer erned ed about t the l e latter er two

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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
• riginal 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?

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Learn More

• www.pcori.org
• info@pcori.org
• #PCORI2017
• www.codastudy.org

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Questions?

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Thank You!

Larry Kessler, Sc.D.

Professor, Department of Health Services, University of Washington CODA Executive Committee Chair @CertainWA November 1st, 2017