How three focus groups and a patient advisory board changed a project 15 years in the making

Context: Acute rhinosinusitis (ARS) is a leading cause of antibiotic use in primary care settings and are prescribed in over 70% of outpatient ARS visits in the United States. In the U.S., one in seven adults (a total of 30 million office visits) every year are diagnosed with ARS, resulting in one in five antibiotics prescribed to adults. However, even with such significant public health issue very little funding has been approved for studying ARS in primary care. In 2009 we were awarded a planning grant (R34) from NIH but subsequently were rejected for study grants by PCORI and the NIH eleven times. We were approved for a large pragmatic trial by PCORI in the summer of 2022.

Objective: Since this was a pragmatic trial we thought it was important to hold focus groups with office workers, nurses, physicians, nurse practitioners and physician assistants. Additionally, a patient advisory board (PAB), that meets bimonthly was arranged.

Study Design and Analysis: Three focus groups were conducted and feedback about the trial design and implementation were sought. The PAB continues to meet and give feedback.

Setting: Six diverse practice-based research networks referred individuals for focus groups and standing PAB meetings.

Outcome Measures: Significant changes to many aspects of the trial resulted, such as changes in inclusion/exclusion, recruitment and outreach to clinical offices.

Outcomes: A conservative estimate is that the study protocol was reviewed and commented on by over 200 professional researchers plus the eleven study sections. Nonprofessional researchers, quickly identified flaws in our research design that should help improve our external validity and allow us to better achieve our sample size. If one wants to conduct a pragmatic trial-real world, generalizable and applicable to real practices-it is imperative to involve non-researchers to improve trial design.