Patient-centered outcomes research involves engagement of healthcare stakeholders to identify, define, develop, conduct, and translate research that will help people make personalized healthcare decisions. The idea for this proposed pragmatic trial emerged during a meeting of frontline clinicians working across Washington state’s Surgical Care and Outcomes Assessment Program, a statewide quality improvement collaborative of hospitals. Most surgeons in the collaborative were trained to recommend an elective colectomy for patients after two to three episodes of uncomplicated diverticulitis, but guidelines have changed to recommend individualizing the decision to operate based on the impact on quality of life of recurrent attacks. Unfortunately, the impact on quality of life of elective colectomy versus best medical management has not been adequately studied. A review of published studies identified only one small European randomized trial of elective colectomy versus best medical management, leaving unanswered a question that millions of patients face every year: Framed from a patient’s perspective, “Should I undergo elective colectomy for diverticulitis or try to avoid an operation via best medical management with a potentially worse quality of life?” Framed from a clinician’s perspective, “Is elective colectomy ‘better than’ best medical management?”
Since diverticulitis is a condition that impacts so many people and because clinicians have training and established practices that favor one approach or the other, to even entertain the question of a definitive randomized trial, we began a yearlong process of engaging stakeholders to assess their opinions. To engage stakeholders, we leveraged the existing stakeholder coordinating center of our ongoing PCORI-funded trial of appendectomy versus antibiotics. Using this established infrastructure and leveraging expertise in generating patient-informed comparative effectiveness research studies, stakeholders helped design the questions related to this topic and address questions of importance and feasibility, such as the following: 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? To answer these questions about feasibility and to inform the development of this proposal, we conducted a series of stakeholder activities, engaging individuals at risk for and individuals with a past history of diverticulitis, surgeons, and the leaders of professional societies. By applying the tools of surveys and one-on-one interviews with patients who had diverticulitis and clinicians who care for them, we used an evidence-based strategy to engage and incorporate their guidance. 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. The input of these stakeholders is represented throughout the grant using text boxes to signal examples of their input.
This engagement resulted in a genuine, stakeholder-informed proposal titled “Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial.” 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.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.