A METHODOLOGICAL INVESTIGATION TO DEFINE A CLINICALLY RELEVANT CUT-OFF POINT IN THE ORDINAL SCALE OF THE EORTC QLQ-C30 QUESTIONNAIRE

Author(s)

Chantal Quinten, MSc, Quality of Life Researcher1, Francesca Martinelli, MSc, Fellow1, Corneel Coens, MSc, Biostatistician1, John Maringwa, PhD, Fellow1, Charles Cleeland, PhD, Professor2, Henning Fechtner, PhD, Director3, Carolyn Gotay, PhD, Professor4, Eva Greimel, PhD, Associate Professor5, Madeleine King, PhD, Director6, David Osoba, PhD, Consultant7, Martin J. B. Taphoorn, PhD, Professor8, Bryce Reeve, PhD, Program Director and Psychometrician9, Jolie Ringash, PhD, Associate Professor10, Joseph Schmucker-Von Koch, PhD, Professor11, Joahcim Weis, PhD, Professor12, Andrew Bottomley, PhD, Assistant Director, Head Quality of Life Department11EORTC, Brussels, Belgium; 2 U.T.M.D. Anderson Cancer Center, Houston, TX, USA; 3 City Hospital Magdeburg, Magdeburg, Germany; 4 University of British Columbia, Vancouver, BC, Canada; 5 Medical University Graz, Graz, Austria; 6 University of Sydney, Sydney, Australia; 7 QOL Consulting, West Vancouver, BC, Canada; 8 VU University Medical Center/Medical Center Haaglanden, Den Haag, Netherlands; 9 National Cancer Institute, Bethesda, MD, USA; 10 The Princess Margaret Hospital, Toronto, ON, Canada; 11 University of Regensburg, Regensburg, Germany; 12 University of Freiburg, Freiburg, Germany

Presentation Documents

OBJECTIVES The objective of this analysis was to develop a new analytic methodology to identify a clinically relevant cut-off point in the EORTC QLQ-C30 ordinal pain score by comparing patient and clinician reporting for the same symptom. Ability to translate between clinician and patient reported symptoms will be useful in planned future analyses. METHODS Closed European Organisation for Research and Treatment of Cancer Randomized Controlled Trials, where the symptom pain was scored at baseline by the patient (EORTC QLQ-C30) and the clinician [Common Toxicity Criteria (CTC)], were pooled and analysed to test the optimal cut-off point. The CTC was dichotomized as 0,1,2 vs. 3,4; defined as a clinical relevant cut-off point for clinical practice. Percent agreement with various dichotomizations of the QLQ-C30 pain scale was calculated, and McNemar's test applied. Verification of the accuracy and generalizibility of the findings was evaluated with a validation set and by applying the same cut-off point on another symptom, i.e. fatigue. RESULTS Data were available for pain [number of trials (t)=8, number of patients (n)=1214] and fatigue [t=5, n=1237]. Model and validation set were obtained by splitting the dataset in half. Percentage agreement and p values for McNemar tests, between patient and clinician dichotomized scores using different cut-off points for the QLQ-scale, were: median (<2.19 vs. >2.19, 64%, p<.01), quartile (

Conference/Value in Health Info

2009-05, ISPOR 2009, Orlando, FL, USA

Value in Health, Vol. 12, No. 3 (May 2009)

Code

PCN90

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Oncology, Systemic Disorders/Conditions

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