Abstract

BackgroundClinical interpretation of health related quality of life (HRQOL) scores is challenging. The purpose of this analysis was to interpret score changes and identify minimal clinically important differences (MCID) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) before (T1) and during (T2) cancer treatment.MethodsPatients (N = 627) in stem cell transplant (SCT) and medical (MED) or radiation (RAD) oncology at two comprehensive cancer centers, enrolled in the Electronic Self-Report Assessment-Cancer study and completed the QLQ-C30 at T1 and T2. Perceived changes in five QOL domains, physical (PF), emotional (EF), social (SF), cognitive functioning (CF) and global quality of life (QOL), were reported using the Subject Significance Questionnaire (SSQ) at T2. Anchored on SSQ ratings indicating “improvement”, “the same”, or “deterioration”, means and effect sizes were calculated for QLQ-C30 score changes. MCID was calculated as the mean difference in QLQ-C30 score changes reflecting one category change on SSQ rating, using a two-piece linear regression model.ResultsA majority of SCT patients (54%) perceived deteriorating global HRQOL versus improvement (17%), while approximately equal proportions of MED/RAD patients perceived improvement (25%) and deterioration (26%). Global QOL decreased 14.2 (SCT) and 2.0 (MED/RAD) units, respectively, among patients reporting “the same” in the SSQ. The MCID ranged 5.7-11.4 (SCT) and 7.2-11.8 (MED/RAD) units among patients reporting deteriorated HRQOL; ranged 2.7-3.4 units among MED/RAD patients reporting improvement. Excepting for the global QOL (MCID =6.9), no meaningful MCID was identified among SCT patients reporting improvement.ConclusionsCancer treatment has greater impact on HRQOL among SCT patients than MED/RAD patients. The MCID for QLQ-C30 score change differed across domains, and differed for perceived improvement and deterioration, suggesting different standards for self-evaluating changes in HRQOL during cancer treatment. Specifically, clinical attention can be focused on patients who report at least a 6 point decrease, and for patients who report at least a 3 point increase on QLQ-C30 domains.Trial registrationThe trial was registered with ClinicalTrials.gov: NCT00852852

Highlights

  • Clinical interpretation of health related quality of life (HRQOL) scores is challenging

  • Quality of Life Questionnaire-Core 30 (QLQ-C30) scores and Subject Significance Questionnaire (SSQ) ratings The mean QLQ-C30 scores were significantly lower at T2 than T1 for Physical function (PF), Social function (SF), cognitive functioning (CF) and the global QOL domains for both MED/RAD and stem cell transplant (SCT) patients, while higher at T2 for EF among both patient groups

  • Based on the guidelines on longitudinal QOL change recommended by Cocks et al [13], the decrease is considered medium in PF (−15.8), SF (−11.76), and CF (−9.51), large in global QOL (−19.19) among SCT patients; and is considered trivial in PF (−4.10), SF(−2.91), CF (−1.46) and global QOL (−3.40) among MED/RAD patients

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Summary

Introduction

Clinical interpretation of health related quality of life (HRQOL) scores is challenging. The purpose of this analysis was to interpret score changes and identify minimal clinically important differences (MCID) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) before (T1) and during (T2) cancer treatment. Health-related quality of life (HRQOL) is an important patient outcome measure following cancer treatment in randomized trials. Significance of differences (or changes) in HRQOL are often interpreted with statistical hypothesis testing using p-values [3]. Clinical investigators are challenged to interpret important changes in HRQOL over time and to determine a minimal clinically important difference (MCID). Understanding the MCID may help clinicians address HRQOL related issues during cancer treatment

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