Thresholds for clinical importance were defined for the European Organisation for Research and Treatment of Cancer Computer Adaptive Testing Core—an adaptive measure of core quality of life domains in oncology clinical practice and research

Abstract

The aim of this article was to establish thresholds for clinical importance (TCIs) for the European Organisation for Research and Treatment of Cancer (EORTC) Computer Adaptive Testing (CAT) Core measure, the new adaptive version of the EORTC QLQ-C30. Study Design and Setting: For our diagnostic study, we recruited cancer patients with mixed diagnoses and treatments from six European countries. Patients completed the EORTC CAT Core and a questionnaire with anchor items assessing criteria for clinical importance (limitations in everyday life, need for help/care, and worries by the patient/family/partner) for each EORTC CAT Core domain. We used a binary variable summarizing the anchor items for determining TCIs and for calculating the area under the curve (AUC) in receiving operator characteristic analysis as a measure of diagnostic accuracy. Results: Using data from 498 cancer patients (mean age 60.4 years, 55.2% women), we established TCIs for the 14 domains of the EORTC CAT Core. Median AUC across domains was 0.93 (range 0.84e0.94). Median sensitivity and specificity of the TCIs were 0.91 (range 0.80e0.96) and 0.77 (range 0.66e0.84), respectively. TCIs and AUCs were largely consistent across patient groups. Conclusion: We have generated TCIs for the 14 functional health and symptom domains of the EORTC CAT Core. The EORTC CAT Core showed high diagnostic accuracy in identifying clinically important symptoms and functional impairments.

Evaluating the Thresholds for Clinical Importance of the EORTC QLQ-C15-PAL in Patients Receiving Palliative Treatment

“…Moreover, the symptom and functional health levels observed in our study sample are broadly comparable with those of the target population. [43][44][45] Considering this and given the robustness of the thresholds for clinical importance across various patient groups observed in previous studies, 22,26,37 our findings may also be valid among patients during the last months of their lives.…”

“…For this cross-sectional study, we relied initially on data from patients with cancer receiving palliative treatment, who were already participating in a study on the development of thresholds for clinical importance for the EORTC QLQ-C30 26 and the EORTC Computer Adaptive Testing (CAT) Core measures. 37 We also utilized prospective data from additional patients who were recruited specifically for this study to reach the sample size required for the analyses (N = 225, see below for power analysis). Initial data were collected in an international study in Austria, Italy, the Netherlands, Poland, Spain, and the United Kingdom using the following inclusion criteria: any cancer diagnosis, any type of treatment, aged >18 years, no overt cognitive impairments, provided written informed consent, and language proficiency in the respective country's primary language.…”

“…39 The methodology is consistent with the previous studies that have developed thresholds for the QLQ-C30 26 and the EORTC CAT Core measures. 37…”

Thresholds and innovation: discussion on statistical significance

“…But too often authors do not recognize that 'no statistical significance' is not the same as 'no effect' and that 'statistically significant' does not mean 'proven'. Moreover, they often ignore the essential difference between statistical significance and clinical relevance of an effect (that must be a priori elaborated as minimal important effect to be detected, or as threshold for clinical importance [5]) As a consequence, clinicians, patients, media, and policy makers may be misled, and harm may be the result.…”

Pilot Clinical and Pharmacokinetic Study of Δ9-Tetrahydrocannabinol and Cannabidiol Oro-Buccal Spray in Advanced Cancer with Uncontrolled Pain.

“…Primary Endpoints: consisted of a clinical assessment of safety and tolerability from recorded adverse events/serious adverse events; quality of life scores as measured with The European Organisation for Research and Treatment of Cancer Quality of Life for Cancer Patients Questionnaire (EORTC QLQ-C30-v3) [22]. The minimum threshold for clinical importance for functioning scales scores were: physical functioning, 83; role functioning, 58; social functioning, 71; emotional functioning, 71; cognitive functioning, 75.…”