Following the successful conclusion of the pilot trial, Fifth Sense is delighted to announce that a full rollout of the MACRO research programme is now in progress.
Funding for clinical research into the causes of smell loss is hard to come by so the MACRO project is an initiative that Fifth Sense has supported wholeheartedly with members helping from the earliest stages of development. The project intends to define the best treatment for chronic rhinosinusitis, a major yet reversible cause of smell loss. The trial is comparing the effectiveness of endoscopic sinus surgery against a twelve-week course of an antibiotic drug called clarithromycin. In the trial all participants will undertake standard treatments of nasal rinsing combined with a corticosteroid nasal spray while being randomly assigned one of three additional treatments – the antibiotic tablets, visually identical placebo tablets (neither the patient nor their consultant will know which is which until the trial ends) or the surgery.
It requires robust and substantial research in order for NHS practitioners to take notice and be motivated to change treatment practices. MACRO certainly fulfils that criterion so it’s perhaps worth elaborating on what is presently happening within the programme.
The pilot involved 58 patients across six sites over 6 months. To support the national rollout, an investigators’ meeting was recently held in London to share the experiences of the pilot phase, to discuss the best ways to recruit patients onto the full-scale trial and to ensure that participants had the best possible experience. All participating consultants and research nurses were invited to the investigators’ meeting from the seventeen hospitals involved in the national trial. Short presentations were given by members of the MACRO research team. A Fifth Sense patient representative also presented and afterwards, panel sessions promoted discussion between the teams at each hospital. Potential patient concerns and questions about participating in the trial were raised and addressed with the aim of maximising both the initial recruitment and patient retention through to the end.
Data will be collected and analysed up to six months after treatment. However, patients will be encouraged to report symptoms up to five years post-trial, allowing the research team to monitor the extent or otherwise to which treatment benefits decline over time.
Full details of the MACRO research programme and the clinical trial hospitals taking part can be found on the MACRO website https://www.themacroprogramme.org.uk/ . Click on the ‘information about participating’ button on the right of the homepage. Be aware that patients are able to request their GP to refer them to a particular consultant for treatment rather than just to their local hospital.