Simon N Rogers1,2, Christine Allmark3, Fazilet Bekiroglu4, Rhiannon Tudor Edwards5, Gillon Fabbroni3, Robert Flavel6, Victoria Highet7, Michael W S Ho3, Gerald M Humphris8, Terry M Jones9, Owais Khattak4, Jeffrey Lancaster4, Christopher Loh4, Derek Lowe10, Cher Lowies7, Dominic Macareavy11, James Moor3, T K Ong3, A Prasai3, Nicholas Roland4, Cherith Semple12,13, Llinos Haf Spencer5, Sank Tandon4, Steven J Thomas14, Andrew Schache4, Richard J Shaw4, Anastasios Kanatas3. 1. Faculty of Health and Social Care, Edge Hill University, Ormskirk, Liverpool, L39 4QP, UK. simonn.rogers@aintree.nhs.uk. 2. Liverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK. simonn.rogers@aintree.nhs.uk. 3. Leeds Teaching Hospitals and St James Institute of Oncology, Leeds Dental Institute and Leeds General Infirmary, Leeds, UK. 4. Liverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK. 5. Centre for Health Economics and Medicines Evaluation (CHEME), School of Health Sciences, College of Human Sciences, Ardudwy Hall, Normal Site, Bangor University, Bangor, Wales, UK. 6. , Southway, Guilford, Surrey, UK. 7. Liverpool Head and Neck Clinical Trials, Clinical Sciences Building, University Hospital Aintree, Liverpool, UK. 8. School of Medicine, Medical & Biological Sciences, North Haugh, St Andrews, UK. 9. Liverpool Head and Neck Centre, University of Liverpool, Cancer Research Centre, University of Liverpool, 200 London Road, Liverpool, L3 9GA, UK. 10. Astraglobe Ltd, Congleton, Cheshire, UK. 11. Chair of the Head and Neck Patient and Carer Research Forum, Liverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK. 12. Institute of Nursing and Health Research, Ulster University, Shore Road, Belfast, Newtownabbey, Co, BT37 0QB, Antrim, Belfast, UK. 13. South Eastern Health and Social Care Upper Newtownards Road, Belfast, BT16 1RH, UK. 14. Oral and Maxillofacial Surgery Department, Bristol University, Lower Maudlin Street, Bristol, UK.
Abstract
PURPOSE: The patient concerns inventory (PCI) is a prompt list allowing head and neck cancer (HNC) patients to discuss 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) social-emotional 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.
RCT Entities:
PURPOSE: The patient concerns inventory (PCI) is a prompt list allowing head and neck cancer (HNC) patients to discuss 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) social-emotional 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.
Authors: Simon N Rogers; Christine Allmark; Fazilet Bekiroglu; Rhiannon Tudor Edwards; Gillon Fabbroni; Robert Flavel; Victoria Highet; Michael W S Ho; Gerald M Humphris; Terry M Jones; Owais Khattak; Jeffrey Lancaster; Christopher Loh; Derek Lowe; Cher Lowies; Dominic Macareavy; James Moor; T K Ong; A Prasai; Nicholas Roland; Cherith Semple; Llinos Haf Spencer; Sank Tandon; Steven J Thomas; Andrew Schache; Richard J Shaw; Anastasios Kanatas Journal: Eur Arch Otorhinolaryngol Date: 2020-12-21 Impact factor: 2.503
Authors: I C van der Meulen; A M May; J R J de Leeuw; R Koole; M Oosterom; G-J Hordijk; W J G Ros Journal: Br J Cancer Date: 2013-11-26 Impact factor: 7.640
Authors: Claire Surr; Alys W Griffiths; Rachael Kelley; Laura Ashley; Fiona Cowdell; Ann Henry; Hayley Inman; Michelle Collinson; Ellen Mason; Amanda Farrin Journal: Support Care Cancer Date: 2020-09-21 Impact factor: 3.603
Authors: Simon N Rogers; Christine Allmark; Fazilet Bekiroglu; Rhiannon Tudor Edwards; Gillon Fabbroni; Robert Flavel; Victoria Highet; Michael W S Ho; Gerald M Humphris; Terry M Jones; Owais Khattak; Jeffrey Lancaster; Christopher Loh; Derek Lowe; Cher Lowies; Dominic Macareavy; James Moor; T K Ong; A Prasai; Nicholas Roland; Cherith Semple; Llinos Haf Spencer; Sank Tandon; Steven J Thomas; Andrew Schache; Richard J Shaw; Anastasios Kanatas Journal: Eur Arch Otorhinolaryngol Date: 2020-12-21 Impact factor: 2.503