Diverticulitis is the inflammation or infection of small pouches that form along the walls of the intestines. The vast majority of people with diverticulitis have occasional abdominal pain that improves with oral antibiotics. Complications in diverticulitis can include the need for emergency surgery, which, for a very small portion of patients (approximately 2%) may result in the need for a patient to have a colostomy. A colostomy is an operation in which a piece of the colon is diverted to an opening in the abdominal wall.
Current practice in the United States recommends that diverticulitis be treated with a colectomy (removal of a section of the colon) after 2-3 episodes of diverticulitis, even if the diverticulitis responds to antibiotics with no other complications. However, guidelines have recently changed to recommend that the impacts that recurring diverticulitis attacks have on patient quality of life be considered when deciding whether or not to perform a colectomy.
University of Washington researchers are now asking the question, “for patients whose diverticulitis reduces their quality of life, is elective colectomy more effective than non-surgical management?” The study that the team at the University of Washington has developed is called the Comparison of Surgery and Medicine on the Impact of Diverticulitis Trial, or COSMID, and recently was funded by the Patient-Centered Outcomes Research Institute (PCORI). The COSMID team worked with clinicians and patients nationwide to develop study plans and confirm the important outcomes to report.
The Patient Advisory Network partnered with the University of Washington team to provide input and insights into diverticulitis treatment, along with representatives from the American College of Surgeons, the American Society for Colorectal Surgery, four statewide surgical quality improvement collaboratives, and two large self-insured employers to develop and prioritize the research topic on which COSMID focuses.
Partners in development provided input through surveys and interviews on questions such as:
- Is this a topic important enough for a large-scale research trial?
- Will clinicians be willing to ask their patients to participate in such a study, and will patients participate if asked?
- What information would patients need to be adequately informed to make a decision about participating in such a trial?
- What outcomes are most important, and will the results actually change practice?
Janice Tufte, a member of the Patient Advisory Network Steering Committee, was one of the patient advisors to participate in the study development. She assisted the team in thinking through how patients approached to participate in the study would think about whether or not to participate – what they would see as benefits and risks of participating, and how their personal experiences with diverticulitis would inform their decision making. “I appreciated the opportunity to tell the study team about my own experiences to help inform a study that will hopefully improve the lives of others living with diverticulitis,” Janice said.
The input of more than 150 patients and survey respondents and 30 surgeons helped shape and highlight the importance of the topic as well as point out expected challenges that needed to be addressed in its design. This engagement resulted in a uniquely stakeholder-informed proposal. COSMID will be a definitive, large-scale, pragmatic, randomized controlled trial of elective colectomy versus best medical management for quality of life–limiting diverticulitis. The COSMID trial focuses on both patient-reported outcomes and clinical outcomes that matter to patients. The results are expected to establish an evidence-based approach to the care of millions of patients per year in the United States and help people impacted by this common condition make more informed treatment decisions.
Interested in learning more about COSMID or getting involved in a patient advisory group? Let us know!