A qualitative study embedded within the MACRO randomized controlled trial explored how patients with chronic rhinosinusitis and clinicians experienced participation in the study comparing endoscopic sinus surgery, clarithromycin, and placebo. Investigators also examined factors that may influence how the trial’s findings are implemented in clinical practice.
Patients with chronic rhinosinusitis (CRS), a chronic inflammatory condition affecting the nasal and paranasal sinus mucosa, commonly present with nasal obstruction, rhinorrhea, facial pain or pressure, and anosmia. The condition can substantially affect quality of life.
The MACRO trial was conducted across 21 secondary and tertiary ear, nose, and throat centers in England and Scotland between 2018 and 2023. In the main trial, 514 patients who had CRS with and without nasal polyps were randomly assigned to endoscopic sinus surgery (ESS), clarithromycin, or placebo. At 6 months, ESS produced greater improvement in patient-reported Sino-Nasal Outcome Test–22 scores compared with clarithromycin or placebo, whereas clarithromycin didn't demonstrate benefit over placebo.
To better understand experiences related to the trial and its treatments, the investigators conducted semistructured interviews with 20 patients approximately 6 months following trial completion and with 17 clinical staff members, including principal investigators, associate investigators, and research nurses. The interviews were analyzed using thematic analysis.
The participants described a range of motivations for joining the trial. Many patients had experienced persistent symptoms despite prior treatment and were seeking additional options. The clinicians reported that patients often entered the study after exhausting standard medical therapies and were interested in exploring alternative approaches.
Patient views on treatment differed. Some of the participants viewed surgery as a logical next step in management, particularly those with nasal polyps. Conversely, other participants expressed concerns about surgical risks, postoperative recovery, or time away from work. The clinicians also noted that some patients were uncomfortable with treatment randomization.
Further, the patients assigned to undergo ESS frequently reported rapid symptom relief, including improved nasal airflow, reduced facial pain, and the recovery of smell. However, postoperative experiences varied. Some patients reported expected symptoms such as congestion, bleeding, or pain, while others experienced complications, including infections or prolonged recovery.
The patients receiving medical therapy generally described more gradual or limited symptom improvement. Some of the participants reported reductions in congestion and the partial recovery of smell, although several of the participants attributed improvement to daily sinus rinsing rather than trial medication. Gastrointestinal symptoms were the most commonly reported adverse effects among the patients receiving clarithromycin.
The clinicians indicated that the MACRO trial findings supporting ESS could help guide discussions with patients about treatment options. Nonetheless, they also identified potential barriers to implementation, including operating theater capacity, surgical waiting lists, and patient hesitancy about surgery.
The investigators concluded that while ESS demonstrated clinical effectiveness in the MACRO trial, implementation will depend on clear communication with patients, support for shared decision-making, and adequate health system resources to support surgical care.
The study was funded by the National Institute for Health and Care Research Programme Grants for Applied Research. The funders had no role in study design, data collection or analysis, the decision to publish, or preparation of the manuscript. The authors reported no competing interests.
Source: BMJ Open
