Description of the Project: For the past 130 years, appendectomy (the surgical removal of the appendix) has been the standard treatment for appendicitis. However, recent studies from Europe have challenged the notion that surgery is the best option by showing that antibiotics alone can work to treat appendicitis. Five randomized trials involving over 1,000 patients have now shown that using antibiotics alone to treat appendicitis can result in acceptable outcomes without the need for surgery in most people. These results are starting to change the way surgeons in Europe treat appendicitis. For example last October, Rafael Nadal, the tennis superstar, was diagnosed with appendicitis at the start of the Shanghai Open. Hoping to go on playing in the tournament, he tried a course of antibiotics instead of surgery. Although he eventually went on to have an appendectomy, the decision he and his doctors made about antibiotics instead of surgery indicates just how influential these studies have been in Europe. Alternatively, US surgeons have pointed to problems with these studies and are reluctant to change their practice until a large-scale, rigorous trial is conducted. As of 2014, less than 1.5 percent of all people with appendicitis in the United States were treated with antibiotics.
Description of the Problem Your Project Seeks to Solve: Given the studies done in Europe, US surgeons and their patients are starting to ask, “Is it time to change our approach to treating appendicitis from offering appendectomy-first to antibiotics-first?”
Outcomes You Hope to Achieve: The proposed study titled “Comparison of Outcomes of Drugs and Appendectomy (CODA)” will be a definitive, large-scale, pragmatic, randomized controlled trial (RCT) comparing appendectomy to antibiotics-first for the treatment of uncomplicated appendicitis. The CODA trial focuses on both clinical outcomes and the patient-reported outcomes (PROs) that matter most to patients. The results are expected to establish an evidence-based approach to appendicitis care. These results will help hundreds of thousands of Americans each year make an important healthcare decision about this common condition.
Brief Background on Why This Project Is Important to Patients: The evidence from Europe supports the use of antibiotics-alone to treat appendicitis, but as with Rafael Nadal, the antibiotics do not always solve the underlying problem. The studies show that 35 percent to 50 percent of people starting antibiotics-first eventually ended up having an appendectomy. These studies did not assess whether or not the benefits of possibly avoiding an operation outweighed the burden of future appendicitis episodes, the number of days with antibiotics and symptoms, and anxiety about future episodes of appendicitis that may impact quality of life (QoL). No studies to date have compared the impact of these two treatments for appendicitis on the overall patient experience or included standard PROs in addition to clinical outcomes. In short, the studies to date have not asked “Is antibiotics-first as good an approach for me as appendectomy?” and that is what the CODA trial aims to address. The answers to this question can help inform hundreds of thousands of people making this high-stakes decision.
How Patients and Other Stakeholder Partners Will Help to Make the Project Successful: The patients’ voice has been incorporated throughout the development of this study and this proposal. The Washington State’s Comparative Effectiveness Research Translation Network (CERTAIN) includes a Patient Advisory Network that is an integral part of the entire research spectrum. In all of CERTAIN’s studies, the Patient Advisory Network participates in all Oversight and Operational Committees, are part of regular monthly meetings, participate in a patient advisor blog post, engage in tweet chats related to findings, and help prepare brief reports and manuscripts. They will continue in these roles for the CODA trial. Furthermore, Patient Partners selected from the CERTAIN Patient Advisory Network have been involved in refining educational materials and study protocols in preparation for this proposal.
The clinical voice has been incorporated into this proposal as well. Practice-site designated quality assurance professionals generated this research question and protocol and will serve as members of a Clinician Advisory Panel, provide input on finalizing the protocol and address site-specific workflow issues, be involved in Operational Committees, participate in regular monthly meetings, manuscript development, and presentations.
Demonstrating the relevance of this trial to employers and insurers, this study has also had high levels of support from these stakeholder groups. In planning this study, we engaged the leadership of major insurance companies (commercial insurers as well as Medicaid and Medicare) and CEOs of several Fortune 500 companies to make sure the CODA trial is most relevant to them and their beneficiaries’/employees’ interests. These groups have also pledged to help disseminate and implement the results through their networks of beneficiaries, employees, and families.
Partners in this proposal also include the largest professional societies of surgeons and emergency medicine clinicians in the United States (the American College of Surgeons and the American College of Emergency Physicians). Both groups have agreed to incorporate the results in educational materials and practice guidelines to improve dissemination and implementation and advise the study team in deploying and operationalizing this study.
Ehlers AP, Davidson GH, Bizzell BJ, et al., Engaging Stakeholders in Surgical Research: The Design of a Pragmatic Clinical Trial to Study Management of Acute Appendicitis, JAMA Surgery (June 2016).