1. Appendectomy vs. Antibiotics The CODA Randomized Trial
Name
Maine Medical Center
Portland, Maine

2. Surgical Research in Appendicitis-Europe

3. The Evidence N=1,724 Outcomes common to both treatments
Complications-higher for surgery
Pain-more for surgery
Days away from work-more for surgery
Length of stay-similar
Outcomes unique to one treatment only
Rates of appendectomy?
By 1 year 25-40% of those randomized to antibiotics had an appendectomy
No higher rate of perforation
Large proportion who had an eventual appendectomy did not have appendicitis

4. Big Evidence Gaps Selection bias Diagnostic criteria
Unusual treatment requirements
High rates of open surgery
Definition of antibiotic failure
Follow up
Standardized measures of patient experience

6. Are antibiotics as effective as appendectomy for appendicitis
Are antibiotics as effective as appendectomy for appendicitis? Which patients are most likely to have a successful outcome with antibiotics-first?
The CODA trial informs this health decision for appendicitis treatment by asking these two research questions.

7. 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)
Observational cohort accounts for selection bias and supports generalizability of study results and will include patients declining randomization. We will ask them to complete similar metrics to those consenting to the RCT.

8. Site Expansion East Coast: NYU-Tisch And Bellevue Hospital Centers
Beth Israel Deaconess Medical Center (BIDMC)
Boston University Medical Center (BMC)
Columbia University Medical Center
Weill Cornell Medicine
Maine Medical Center
Midwest:
University of Michigan
The Ohio State University
Henry Ford Health Systems
West:
University of Colorado Denver*
South:
University of Mississippi
Vanderbilt Medical Center
UT Health & LBJ Medical Center (TX)
Bolded sites have already launched
*Potential sites

9. Site launches UT Health, LBJ & Maine Medical expected launch April/May
Cornell expected launch this summer

10. CODA Current Study Sites
UW Medical Center
Harborview Medical Center
Madigan Army Medical Center
UCLA Medical Center – Olive View
UCLA Medical Center – Harbor
University of Mississippi Medical Center
Beth Israel Deaconess Medical Center
Columbia University Irving Medical Center
Vanderbilt University Medical Center
Boston Medical Center (Boston University)
Virginia Mason Medical Center
Providence Regional Medical Center – Everett
Swedish Medical Center – First Hill
University of Michigan Medical Center
Tisch Hospital NYU Langone Medical Center
Bellevue Hospital Center NYU School of Medicine
Henry Ford Health System
The Ohio State Wexner Medical Center

11. Minimal Exclusion Criteria
Pre-hoc Exclusions for Appendicitis
Abscess, free air, diffuse peritonitis, overwhelming sepsis
(Patients with CT imaging reporting perforation are being included in the study)
Pregnancy
Both treatments are not an option:
Allergic to all study antibiotics
Immunocompromised
Appendectomy would likely result in ileocecectomy b/c of advanced disease related to appendicitis (e.g., severe phlegmon)
We are including adult English and Spanish speaking patients who present with radiographic confirmed acute uncomplicated appendicitis without accepted contraindications to one of the treatment arms– for instance: diffuse peritonitis or septic shock all surgeons agree need an operation and are CI for antibiotics. Similarly, if a patient has such a large phlegmon or abscess then surgery may be CI and they would not be eligible to randomize.

12. Standardizing Patient Information
6-minute video given to all patients diagnosed with appendicitis
English and Spanish
Collaborative development: surgeons, ED docs, media team and patient advisors

13. Recruitment to Date (May 2nd, 2018 )
Giana, let me know if these don’t make sense to you for any reason… wasn’t sure what you wanted for the % in RCT so swapped it for actual numbers.

14. Reminder: CODA is Team-Based Care
Residents: the patient’s clinical diagnosis and care +
Research coordinators: the CODA protocol and tools to aid in recruitment
We understand you are the experts on the patient’s clinical diagnosis and care. We are working tirelessly to make sure that there is seamless coordination between the ED, surgical, and CODA teams. The research coordinators are the experts on CODA, and would be happy to answer any questions you have in regards to the protocol, eligibility, or next steps for these patients. We have numerous tools which aid in patient recruitment and give standardized information to the patients **(VIDEO). For example we have a 6 min video that ALL patients in the study watch to understand how RCTs work in general, and to give them a brief overview of the study details. We do rely on the clinical team to answer any clinical question the patient has after we walk them through the consent process.
Critical for seamless coordination between:
ED team
Surgery
CODA research coordinators

15. INSERT PHONE NUMBER Appy? Page CODA! What if it is after midnight?
Ask the patient: Are you willing to receive initial antibiotics and wait to speak with a CODA research coordinator at 6am?
Page CODA!
Give patient initial round of antibiotics and continue to update your clinical team on the status of this patient.
So what happens when you have an appendicitis case….. Page CODA! Our team will already been screening the ED dashboard to verify eligibility, but they will work with both the ED team and the surgical team to make sure the patient gets all the information necessary before making a decision.
The ED team is critical! You see the patient first. While the RCs do keep an eye on the ED dashboard for incoming appendicitis cases, receiving a page from the ED confirming a potential CODA patient is important to ensure we don’t miss any patients.
In a perfect world, all patients would come in during daylight hours! But this isn’t the case. So what do you do when you have a patient that presents after midnight?

16. Presenting CODA to Patients
Your CT scan confirms you’ve got appendicitis. We are participating in an important research project that is trying to figure out the best treatment for appendicitis.
I think you’re a great candidate for this national appendicitis study we’re participating in.
Can I invite a research coordinator in to show you a video and talk to you about this ground breaking study?
 We realize that patients might have lots of questions while they wait for the research team to arrive. It’s very helpful if you remain neutral on both treatments, so as not to bias the patient in their decision making. Some key points that many of you have used in the past are:
You’ve got appendicitis
This hospital is one of ten* participating nationwide in an important research study that is trying to figure out if the antibiotics approach is just as good as surgery
Our study allows you a 50% chance of getting antibiotics and a 50% chance of getting surgery
Antibiotics are started here in the ER; most patients go home and continue taking antibiotics
We’ve learned from studies in Europe that this approach is safe
Can a Research Coordinator show you a brief video that explains the different treatments for appendicitis in more detail?
(*10 because we are expanding)

17. What if the patient has questions?
Remind the patient that the RC is presenting this information because you believe either treatment is safe for the patient
Remain neutral
Partner with the RC to answer any study questions
What happens if the patient has questions before the RC gets there? Or after watching the video?
Remember that every comment you make – such as “antibiotics are “new” treatment” or “Surgery is the standard treatment”, can potentially bias the patient.
Remind the patient that the RC is presenting this information because you believe EITHER treatment is safe for the patient
Remain neutral
Partner with the RC to answer any study questions
In a perfect world, patients would always be eligible for CODA. Sometimes it’s not always so clear cut.

18. What if the patient asks me “what would YOU do?”
I’ll be honest, I’m biased because I’m a surgeon. That’s like asking a contractor if they think you should do a kitchen remodel.
That's a really common question we get.  The truth is that it is impossible for me to say what I would do if I were in your shoes because we don’t have answers for many of the questions my patients have, such as: “which treatment will get me back to work sooner” or “which will have less pain”. ?
We do know that you are a candidate for either treatment option
This is a question providers get all the time. Here are two examples of the kind of response you can give:
“That's a really common question we get.  The truth is that it is impossible for me to say what I would do if I were in your shoes because we don’t have answers for many of the questions my patients have, such as: “which treatment will get me back to work sooner” or “which will have less pain”.”
“I’ll be honest, I’m biased because I’m a surgeon. That’s like asking a contractor if they think you should do a kitchen remodel.”
This is a good time to restate that this the reason we are doing the CODA study.  And reminding the patient that they’re a great candidate for either treatment option and that participating in a RCT helps future patients make those decisions.”

19. Reminders…. Page CODA for ALL appy cases {INSERT SITE SPECIFIC NUMBER}
Remain neutral
Ask the patient if a CODA research coordinator can talk to them further about the study.
*For patients presenting to ED between midnight and 6 am: ASK: are you willing to receive initial antibiotics and wait to speak with a CODA research coordinator at 6am?
Just a last reminder:
Remain neutral
Ask the patient if a CODA research coordinator can talk to them further about the study.
*For patients presenting to ED between midnight and 6 am: ASK: are you willing to receive initial antibiotics and wait to speak with a CODA research coordinator at 6am?

20. Thank you for helping to make CODA a success
Thank you for helping to make CODA a success! I am happy to you all a copy of these slides if you’d like to revist them at a later date.