issues that otherwise might be overlooked. This trial evaluated the effectiveness of using the PCI at routine outpatient clinics
for one year after treatment on health-related QOL (HRQOL).
Methods A pragmatic cluster preference randomised control trial with 15 consultants, 8 ‘using’ and 7 ‘not using’ the PCI
intervention. Patients treated with curative intent (all sites, disease stages, treatments) were eligible.
Results Consultants saw a median (inter-quartile range) 16 (13–26) patients, with 140 PCI and 148 control patients. Of the
pre-specified outcomes, the 12-month results for the mean University of Washington Quality of Life (UW-QOLv4) socialemotional
subscale score suggested a small clinical effect of intervention of 4.6 units (95% CI 0.2, 9.0), p = 0.04 after full
adjustment for pre-stated case-mix. Results for UW-QOLv4 overall quality of life being less than good at 12 months (primary
outcome) also favoured the PCI with a risk ratio of 0.83 (95% CI 0.66, 1.06) and absolute risk 4.8% (− 2.9%, 12.9%) but
without achieving statistical significance. Other non-a-priori analyses, including all 12 UWQOL domains and at consultant
level also suggested better HRQOL with PCI. Consultation times were unaffected and the number of items selected
decreased over time.
Conclusion This novel trial supports the integration of the PCI approach into routine consultations as a simple low-cost means
of benefiting HNC patients. It adds to a growing body of evidence supporting the use of patient prompt lists more generally.
- Head and neck cancer
- Patient concerns inventory
- quality of life
- patient-reported outcome
- randomised trial