A core outcome set for patient-reported dysphagia for use in head and neck cancer clinical trials: An international multistakeholder Delphi study.
Delphi study
core outcome set
head and neck cancer
patient reported outcomes
swallowing
Journal
Head & neck
ISSN: 1097-0347
Titre abrégé: Head Neck
Pays: United States
ID NLM: 8902541
Informations de publication
Date de publication:
10 Jan 2024
10 Jan 2024
Historique:
received:
11
10
2023
accepted:
24
12
2023
medline:
11
1
2024
pubmed:
11
1
2024
entrez:
11
1
2024
Statut:
aheadofprint
Résumé
Measuring dysphagia-related patient-reported outcomes (PROs) in Head and Neck Cancer (HNC) patients is challenging due to dysphagia's multidimensional impact, causing inconsistency in outcome reporting. To address this issue, this study derived a consensus-based core outcome set (COS) for patient-reported dysphagia in HNC clinical trials where swallowing is a primary or secondary endpoint. A sample of HNC clinicians, researchers, patients, and caregivers participated in a 2-Round Delphi technique. A Delphi survey, containing a comprehensive list of dysphagia-related PROs, was developed. In Round 1, participants rated item importance on a 5-point scale. Items rated ≥4 by >70% advanced to Round 2, where a consensus meeting addressed items with varied opinions, and the Delphi survey with remaining items was completed. Items rated ≥4 by >70% formed the final COS. Forty-five participants from nine countries were recruited. After Round 1, 40 items were excluded and 64 advanced to Round 2. After Round 2, a 7-outcome COS was established, comprising the domains of dysphagia symptoms, health status and quality of life. This study achieved consensus among HNC stakeholders on essential dysphagia PROs for HNC clinical trials. It is advisable to include these 7-core concepts in clinical trials involving people with HNC to facilitate treatment comparisons and data synthesis.
Sections du résumé
BACKGROUND
BACKGROUND
Measuring dysphagia-related patient-reported outcomes (PROs) in Head and Neck Cancer (HNC) patients is challenging due to dysphagia's multidimensional impact, causing inconsistency in outcome reporting. To address this issue, this study derived a consensus-based core outcome set (COS) for patient-reported dysphagia in HNC clinical trials where swallowing is a primary or secondary endpoint.
METHODS
METHODS
A sample of HNC clinicians, researchers, patients, and caregivers participated in a 2-Round Delphi technique. A Delphi survey, containing a comprehensive list of dysphagia-related PROs, was developed. In Round 1, participants rated item importance on a 5-point scale. Items rated ≥4 by >70% advanced to Round 2, where a consensus meeting addressed items with varied opinions, and the Delphi survey with remaining items was completed. Items rated ≥4 by >70% formed the final COS.
RESULTS
RESULTS
Forty-five participants from nine countries were recruited. After Round 1, 40 items were excluded and 64 advanced to Round 2. After Round 2, a 7-outcome COS was established, comprising the domains of dysphagia symptoms, health status and quality of life.
CONCLUSION
CONCLUSIONS
This study achieved consensus among HNC stakeholders on essential dysphagia PROs for HNC clinical trials. It is advisable to include these 7-core concepts in clinical trials involving people with HNC to facilitate treatment comparisons and data synthesis.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : Peterborough K. M. Hunter Charitable Foundation
Organisme : Canada Excellence Research Chairs, Government of Canada
Informations de copyright
© 2024 The Authors. Head & Neck published by Wiley Periodicals LLC.
Références
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394-424.
Garcia-Peris P et al. Long-term prevalence of oropharyngeal dysphagia in head and neck cancer patients: impact on quality of life. Clin Nutr. 2007;26(6):710-717.
Hutcheson KA, Nurgalieva Z, Zhao H, et al. Two-year prevalence of dysphagia and related outcomes in head and neck cancer survivors: an updated SEER-Medicare analysis. Head Neck. 2019;41(2):479-487.
Patterson JM, McColl E, Carding PN, Wilson JA. Swallowing beyond six years post (chemo)radiotherapy for head and neck cancer; a cohort study. Oral Oncol. 2018;83:53-58.
Greco E, Ringash J, Tomlinson G, et al. Presence and duration of feeding tube in a 5-year cohort of patients with head and neck cancer treated with curative intensity-modulated radiation therapy. Head Neck. 2021;43:1610-1620.
Vermaire JA, Raaijmakers CPJ, Monninkhof EM, et al. The course of swallowing problems in the first 2 years after diagnosis of head and neck cancer. Support Care Cancer. 2022;30(11):9527-9538.
Bressan V, Bagnasco A, Aleo G, et al. The life experience of nutrition impact symptoms during treatment for head and neck cancer patients: a systematic review and meta-synthesis. Support Care Cancer. 2017;25(5):1699-1712.
Denaro N, Merlano MC, Russi EG. Dysphagia in head and neck cancer patients: pretreatment evaluation, predictive factors, and assessment during radio-chemotherapy, recommendations. Clin Exp Otorhinolaryngol. 2013;6(3):117-126.
Lipscomb J, Donaldson MS, Hiatt RA. Cancer outcomes research and the arenas of application. J Natl Cancer Inst Monogr. 2004;33:1-7.
Di Maio M, Basch E, Denis F, et al. The role of patient-reported outcome measures in the continuum of cancer clinical care: ESMO Clinical Practice Guideline. Ann Oncol. 2022;33(9):878-892.
Rogers SN, Barber B. Using PROMs to guide patients and practitioners through the head and neck cancer journey. Patient Relat Outcome Meas. 2017;8:133-142.
Pedersen A, Wilson J, McColl E, Carding P, Patterson J. Swallowing outcome measures in head and neck cancer-how do they compare? Oral Oncol. 2016;52:104-108.
Arrese LC, Carrau R, Plowman EK. Relationship between the eating assessment Tool-10 and objective clinical ratings of swallowing function in individuals with head and neck cancer. Dysphagia. 2017;32(1):83-89.
Manduchi B, Che Z, Ringash J, Fitch M, Howell D, Martino M. “Patient-reported outcome measures for dysphagia in head and neck cancer: a systematic review and appraisal of content validity and internal structure”. Manuscript submitted for publication.
Nund RL, Brown B, Ward EC, et al. What are we really measuring? A content comparison of swallowing outcome measures for head and neck cancer based on the international classification of functioning, disability and health (ICF). Dysphagia. 2019;34(4):575-591.
Greco E, Simic T, Ringash J, Tomlinson G, Inamoto Y, Martino R. Dysphagia treatment for patients with head and neck cancer undergoing radiation therapy: a meta-analysis review. Int J Radiat Oncol Biol Phys. 2018;101(2):421-444.
Williamson PR, Altman DG, Bagley H, et al. The COMET handbook: version 1.0. Trials. 2017;18(Suppl 3):280.
Clarke M. Standardising outcomes for clinical trials and systematic reviews. Trials. 2007;8:39.
Williamson PR, de Ávila Oliveira R, Clarke M, et al. Assessing the relevance and uptake of core outcome sets (an agreed minimum collection of outcomes to measure in research studies) in Cochrane systematic reviews: a review. BMJ Open. 2020;10(9):e036562.
Cochrane Community Blog. Cochrane and COMET: Working Together to Improve Core Outcome Sets. 2017. Accessed April, 2021. https://community.cochrane.org/news/cochrane-and-comet-working-together-improve-core-outcome-sets
Kirkham JJ, Gorst S, Altman DG, et al. Core outcome set-STAndardised protocol items: the COS-STAP statement. Trials. 2019;20(1):116.
Muscedere J, Afilalo J, Araujo de Carvalho I, et al. Moving towards common data elements and Core outcome measures in frailty research. J Frailty Aging. 2020;9(1):14-22.
Williamson PR, Altman DG, Blazeby JM, et al. Developing core outcome sets for clinical trials: issues to consider. Trials. 2012;13:132.
Chera BS, Eisbruch A, Murphy BA, et al. Recommended patient-reported core set of symptoms to measure in head and neck cancer treatment trials. J Natl Cancer Inst. 2014;106(7):1-4.
Waters AM. A Core Outcome Set for Clinical Trials in Oropharyngeal Cancer. University of Liverpool; 2017.
Tschiesner U, Rogers S, Dietz A, Yueh B, Cieza A. Development of ICF core sets for head and neck cancer. Head Neck. 2010;32(2):210-220.
Manduchi B, Che Z, Fitch MI, Ringash J, Howell D, Martino R. Psychometric properties of patient-reported outcome measures for dysphagia in head and neck cancer: a systematic review protocol using COSMIN methodology. Syst Rev. 2022;11(1):27.
Dodd S, Clarke M, Becker L, Mavergames C, Fish R, Williamson PR. A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery. J Clin Epidemiol. 2018;96:84-92.
Kirkham JJ, Gorst S, Altman DG, et al. Core outcome set-STAndards for reporting: the COS-STAR statement. PLoS Med. 2016;13(10):e1002148.
Manduchi B, Fitch M, Ringash J, Howell D, Martino R. A Delphi Study to Derive a Core Outcome Set for Patient-Reported Outcomes Related to Dysphagia in Head and Neck Cancer. 2021. Accessed August, 2023. https://www.comet-initiative.org/Studies/Details/1870
Bjordal K, Ahlner-Elmqvist M, Tollesson E, et al. Development of a European Organization for Research and Treatment of cancer (EORTC) questionnaire module to be used in quality of life assessments in head and neck cancer patients. EORTC Quality of Life Study Group. Acta Oncol. 1994;33(8):879-885.
Singer SAC, Arraras JI, Baumann I, et al. Measuring quality of life in patients with head and neck cancer: update of the EORTC QLQ-H&N module, phase III. Head Neck. 2015;37(9):1358-1367.
Chan KMK, Chan HKW, Siu JYL, Pu D, Nund RL, Ward EC. Impact of head and neck cancer treatment on survivors' mealtime experience. Laryngoscope. 2019;129(7):1572-1578.
Chen AY, Frankowski R, Bishop-Leone J, et al. The development and validation of a dysphagia-specific quality-of-life questionnaire for patients with head and neck cancer: the M. D. Anderson dysphagia inventory. Arch Otolaryngol Head Neck Surg. 2001;127(7):870-876.
Al Wattar BH, Tamilselvan K, Khan R, et al. Development of a core outcome set for epilepsy in pregnancy (E-CORE): a national multi-stakeholder modified Delphi consensus study. BJOG. 2017;124(4):661-667.
Jones J, Hunter D. Consensus methods for medical and health services research. BMJ. 1995;311(7001):376-380.
Sinha IP, Gallagher R, Williamson PR, Smyth RL. Development of a core outcome set for clinical trials in childhood asthma: a survey of clinicians, parents, and young people. Trials. 2012;13:103.
Duncan S, Mc Gaughey J, Fallis R, McAuley DF, Walshe M, Blackwood B. Development of a Core Outcome Set for Trials of Dysphagia Interventions in Critical Care. 2020. Accessed August, 2023. https://www.comet-initiative.org/Studies/Details/1565
Hirschwald J, Hofacker J, Duncan S, Walshe M. Development of a Core Outcome Set for Trials of Dysphagia Interventions in Parkinson's Disease (COS-DIP). 2020. Accessed August, 2023. https://www.comet-initiative.org/Studies/Details/1942
Fan X, Du Y, Wang S, Li L, Liu J. Development of Core Outcome Set for Clinical Trials of Traditional Chinese Medicine in Dysphagia. 2022. Accessed August, 2023. https://www.comet-initiative.org/Studies/Details/2102
COREOS Collaborators, Ma C, Schoepfer AM, et al. Development of a core outcome set for therapeutic studies in eosinophilic esophagitis (COREOS). J Allergy Clin Immunol. 2022;149(2):659-670.
van Tuyl LH, Boers M. Patient-reported outcomes in core domain sets for rheumatic diseases. Nat Rev Rheumatol. 2015;11(12):705-712.
Ramsey I, Eckert M, Hutchinson AD, Marker J, Corsini N. Core outcome sets in cancer and their approaches to identifying and selecting patient-reported outcome measures: a systematic review. J Patient Rep Outcomes. 2020;4(1):77.
Murphy BA, Wulff-Burchfield E, Ghiam M, Bond SM, Deng J. Chronic systemic symptoms in head and neck cancer patients. J Natl Cancer Inst Monogr. 2019;2019(53):72-85.
Rosenthal DI, Mendoza TR, Fuller CD, et al. Patterns of symptom burden during radiotherapy or concurrent chemoradiotherapy for head and neck cancer: a prospective analysis using the University of Texas MD Anderson Cancer Center Symptom Inventory-Head and Neck Module. Cancer. 2014;120(13):1975-1984.
Wulff-Burchfield E, Dietrich MS, Ridner S, Murphy BA. Late systemic symptoms in head and neck cancer survivors. Support Care Cancer. 2019;27(8):2893-2902.
van Beek FE, Jansen F, Mak L, et al. The course of symptoms of anxiety and depression from time of diagnosis up to 2 years follow-up in head and neck cancer patients treated with primary (chemo)radiation. Oral Oncol. 2020;102:104576.
Ren JL, Rojo RD, Perez JVD, Yeung SCJ, Hanna EY, Reyes-Gibby CC. Variations in pain prevalence, severity, and analgesic use by duration of survivorship: a cross-sectional study of 505 post-treatment head and neck cancer survivors. BMC Cancer. 2021;21(1):1304.
Macfarlane TV, Wirth T, Ranasinghe S, Ah-See KW, Renny N, Hurman D. Head and neck cancer pain: systematic review of prevalence and associated factors. J Oral Maxillofac Res. 2012;3(1):e1.
Cohen EE, LaMonte S, Erb NL, et al. American Cancer Society head and neck cancer survivorship care guideline. CA Cancer J Clin. 2016;66(3):203-239.
Bossi P, di Pede P, Guglielmo M, et al. Prevalence of fatigue in head and neck cancer survivors. Ann Otol Rhinol Laryngol. 2019;128(5):413-419.
Fan CY, Chao HL, Lin CS, et al. Risk of depressive disorder among patients with head and neck cancer: a nationwide population-based study. Head Neck. 2018;40(2):312-323.
Ghazali N, Cadwallader E, Lowe D, Humphris G, Ozakinci G, Rogers SN. Fear of recurrence among head and neck cancer survivors: longitudinal trends. Psychooncology. 2013;22(4):807-813.
Hammermuller C, Hinz A, Dietz A, et al. Depression, anxiety, fatigue, and quality of life in a large sample of patients suffering from head and neck cancer in comparison with the general population. BMC Cancer. 2021;21(1):94.
Mehnert A, Brähler E, Faller H, et al. Four-week prevalence of mental disorders in patients with cancer across major tumor entities. J Clin Oncol. 2014;32(31):3540-3546.
Martino R, Beaton D, Diamant, NE. Using different perspectives to generate items for a new scale measuring medical outcomes of dysphagia (MOD). J Clin Epidemiol. 2009;62(5):518-526. doi:10.1016/j.jclinepi.2008.05.007
Patterson JM. Late effects of organ preservation treatment on swallowing and voice; presentation, assessment, and screening. Front Oncol. 2019;9:401.
Meyer TK, Pisegna JM, Krisciunas GP, Pauloski BR, Langmore SE. Residue influences quality of life independently of penetration and aspiration in head and neck cancer survivors. Laryngoscope. 2017;127(7):1615-1621.
Prinsen CA, Vohra S, Rose MR, et al. How to select outcome measurement instruments for outcomes included in a “core outcome set”-a practical guideline. Trials. 2016;17(1):449.
Woisard V, Andrieux MP, Puech M. Validation of a self-assessment questionnaire for swallowing disorders (Deglutition Handicap Index). Rev Laryngol Otol Rhinol (Bord). 2006;127(5):315-325.
Belafsky PC, Mouadeb DA, Rees CJ, et al. Validity and reliability of the Eating Assessment Tool (EAT-10). Ann Otol Rhinol Laryngol. 2008;117(12):919-924.
Nie M, Liu C, Pan YC, et al. Development and evaluation of oral cancer quality-of-life questionnaire (QOL-OC). BMC Cancer. 2018;18(1):523.
Cooperstein E, Gilbert J, Epstein JB, et al. Vanderbilt Head and Neck Symptom Survey version 2.0: report of the development and initial testing of a subscale for assessment of oral health. Head Neck. 2012;34(6):797-804.
Cella D, Riley W, Stone A, et al. The patient-reported outcomes measurement information system (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010;63(11):1179-1194.
EORTC Quality of Life Group. EORTC Quality of Life Item Library. Accessed July, 2023. https://qol.eortc.org/item-library/
de Ligt KM, de Rooij BH, Hedayati E, et al. International development of a patient-centered core outcome set for assessing health-related quality of life in metastatic breast cancer patients. Breast Cancer Res Treat. 2023;198(2):265-281.
Ramsey I, Corsini N, Hutchinson AD, Marker J, Eckert M. A core set of patient-reported outcomes for population-based cancer survivorship research: a consensus study. J Cancer Surviv. 2021;15(2):201-212.
Reynolds KA, Schlessinger DI, Vasic J, et al. Core outcome set for actinic keratosis clinical trials. JAMA Dermatol. 2020;156(3):326-333.