Chronic rhinosinusitis: a qualitative study of patient and clinician experiences of the MACRO randomised controlled trial of surgical versus medical management

Objectives
To explore patient and clinician experiences of participation in the MACRO randomised controlled trial (RCT)—which found endoscopic sinus surgery (ESS) to be clinically effective whereas clarithromycin was no better than placebo for chronic rhinosinusitis (CRS)—and to identify barriers and facilitators to the implementation of the trial results.


Design
Qualitative study embedded within the multicentre MACRO RCT. Semistructured interviews with patients and clinicians were analysed using thematic analysis.


Setting
21 secondary and tertiary ear, nose and throat centres in England and Scotland participating in the MACRO RCT.


Participants
20 CRS patients (16 with nasal polyps, 4 without) were interviewed approximately 6 months after trial completion, and 17 clinical staff including principal investigators (PIs), associate PIs and research nurses.


Results
This study explored patients’ and clinicians’ experiences of the trial to identify barriers and facilitators to implementing the findings. Adopting the outcomes of the trial would involve recommending surgery to more patients with CRS. Yet patient and clinician interviews highlighted polarised views on ESS among patients, between those with positive experiences and expectations of ESS and those expressing fear of complications and hesitancy to receive surgery. During the trial, many participants randomised to surgery reported rapid improvement in symptoms, but with postoperative challenges for some patients including pain, unexpected symptoms and variations in recovery period. Priorities for implementation include providing patients with information about risks and support to make informed choices. Clinicians also reflected on the resource implications for offering ESS to more patients.


Conclusions
ESS is effective for CRS, but patient hesitancy and recovery concerns persist. Implementation requires clear communication, recognition and respect for individual preferences, tailored support for decision-making and post-surgical care to optimise acceptance and outcomes.


Trial registration number

ISRCTN36962030
.