Establishing Thresholds for Clinical Importance for EORTC Questionnaire Modules for Eight Specific Groups of Cancer Patients
Author(s)
Pilz MJ1, Thurner AMM1, Belancic A2, Arraras JI3, Bultijnck R4, De Ligt K5, Pogoda K6, Bjelic-Radisic V7, Moodley Y8, Schmidt H9, Mueller JA9, Turhal G10, Chalk T11, Grønvold M12, Giesinger J1
1Medical University of Innsbruck, Innsbruck, Austria, 2Cinical Hospital Centre Rijeka, Rijeka, 08, Croatia, 3Oncology Departments, Hospital Universitario de Navarra, Pamplona, Navarre, Spain, 4Department of Human Structure and Repair, Ghent University, Ghent, Ghent, Belgium, 5Department of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Amsterdam, North Holland, Netherlands, 6Maria Sklodowska-Curie Institute - Oncology Center, Warsaw, Warsaw, Poland, 7Breast Unit, Helios University Clinic Wuppertal, University Witten/Herdecke,, Wuppertal, Nordrhein-Westfalen, Germany, 8Division of Health Systems and Public Health, Stellenbosch University, Cape Town, Western Cape, South Africa, 9Department for Radiation Medicine, Medical Faculty Martin Luther University, Halle/Saale, Sachsen-Anhalt, Germany, 10Department of Otolaryngology, Ege University School of Medicine, Izmir, Izmir, Turkey, 11Supportive Oncology Research Team, East & North Hertfordshire NHS Trust incorporating Mount Vernon Cancer Centre, Northwood, London, UK, 12Palliative Care Research Unit,Bispebjerg and Frederiksberg Hospital, Copenhagen, Copenhagen City, Denmark
Presentation Documents
OBJECTIVES: This study aims to establish thresholds for clinical importance (TCIs) for eight questionnaire modules from the European Organisation for Research and Treatment of Cancer (EORTC) measurement system. The TCIs established for the questionnaire modules will support the interpretation of absolute PRO scores obtained from an individual patient at a single point in time.
The selected modules complement the QLQ-C30 core questionnaire and assess health-related quality of life and symptoms in patients with lung cancer (QLQ-LC29), prostate cancer (QLQ-PR25), breast cancer (QLQ-BR45), colorectal cancer (QLQ-CR29), endometrial cancer (QLQ-EN24), ovarian cancer (QLQ-OV28), head&neck cancer (QLQ-H&N43) and in elderly cancer patients (QLQ-ELD14).METHODS: In a multicentre study across 11 countries, we are currently recruiting N=225 patients from the target population of each module (i.e. N=1800 patients in total). Following the methodology previously developed for establishing TCIs for the QLQ-C30, the thresholds for the questionnaire modules are based on anchor items that assess the limitations of everyday life, worries, and the need for help/treatment for each individual questionnaire domain.
RESULTS: At the time of abstract submission, N=750 patients had been recruited. Preliminary analyses for determining thresholds were conducted. For example, for the QLQ-BR45 available data from N=200 breast cancer patients indicates that its 13 scales can identify clinically important symptoms and impairments with mostly good diagnostic accuracy (Area Under the Curve in the ROC analysis was highest for the scales Endocrine Sexual Symptoms with a value of 0.931, for Breast Symptoms with 0.878, and Arm Symptoms with 0.877). Detailed results will be presented at the conference.
CONCLUSIONS: TCIs will facilitate the use of the EORTC modules for symptom screening in daily clinical practice. Additionally, they can be used to calculate prevalence rates for symptoms and impairments and may be used for the definition of responders in trial endpoints.
Conference/Value in Health Info
Value in Health, Volume 27, Issue 12, S2 (December 2024)
Code
PCR98
Topic
Clinical Outcomes, Patient-Centered Research
Topic Subcategory
Clinical Outcomes Assessment, Instrument Development, Validation, & Translation, Patient-reported Outcomes & Quality of Life Outcomes
Disease
Oncology