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This trial evaluated the effectiveness of using the PCI at routine outpatient clinics for one year after treatment on health-related QOL (HRQOL).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>A pragmatic cluster preference randomised control trial with 15 consultants, 8 \u2018using\u2019 and 7 \u2018not using\u2019 the PCI intervention. Patients treated with curative intent (all sites, disease stages, treatments) were eligible.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Consultants saw a median (inter-quartile range) 16 (13\u201326) 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) social-emotional subscale score suggested a small clinical effect of intervention of 4.6 units (95% CI 0.2, 9.0), <jats:italic>p<\/jats:italic>\u2009=\u20090.04 after full adjustment for pre-stated case-mix. Results for UW-QOLv4 overall quality of life being less than good at 12\u00a0months (primary outcome) also favoured the PCI with a risk ratio of 0.83 (95% CI 0.66, 1.06) and absolute risk 4.8% (\u2212\u20092.9%, 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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>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.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s00405-020-06533-3","type":"journal-article","created":{"date-parts":[[2020,12,21]],"date-time":"2020-12-21T14:03:08Z","timestamp":1608559388000},"page":"3435-3449","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":31,"title":["Improving quality of life through the routine use of the patient concerns inventory for head and neck cancer patients: main results of a cluster preference randomised controlled trial"],"prefix":"10.1007","volume":"278","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5989-6142","authenticated-orcid":false,"given":"Simon N.","family":"Rogers","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"Allmark","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fazilet","family":"Bekiroglu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rhiannon Tudor","family":"Edwards","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gillon","family":"Fabbroni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Flavel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victoria","family":"Highet","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael W. 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We do not have financial disclosure or any conflict of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The PCI trial has ethical approval from North West-Liverpool Central Research Ethics Committee REC reference: IRAS 16\/NW\/0465, Project ID: 189554. It also has approval from the Health Research Authority (HRA). The Research and Development Department at Aintree University Hospital NHS Trust (AUH) is coordinating the trial and AUH is the sponsor for the trial. Trial registration: 32,382. Clinical Trials Identifier, NCT03086629. The study complied with all aspects of ethical standards of clinical research.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"As part of the trial patients consented to the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}