Validation of the EORTC QLQ-C30 quality of life questionnaire through combined qualitative and quantitative assessment of patient-observer agreement

doi:10.1016/S0895-4356(96)00428-3

Journal of Clinical Epidemiology

Volume 50, Issue 4, April 1997, Pages 441-450

https://doi.org/10.1016/S0895-4356(96)00428-3 Get rights and content

Abstract

Patient-rated questionnaires are increasingly used to assess health-related quality of life. We studied one aspect of the validity of such measures that has rarely been investigated: do patients interpret questionnaires in the same way as do the researchers reporting the results? If not, there may be a problem. We employed the EORTC QLQ-C30 quality-of-life questionnaire to study 95 cancer patients and measured the agreement between (1) the patient's self-assessment and (2) an observer's rating of the patient's open-ended responses to the same questionnaire administered as an interview. The observer made qualitative recordings describing potential misinterpretations. The agreement between patients' and observers' ratings was high (median kappa = 0.85, range 0.49–1.00). The qualitative data revealed a few minor validity problems. One of these, selective reporting, may lead to systematic errors: some patients reported only what they considered “relevant” symptoms. The combination of quantitative and qualitative methods proved useful for questionnaire validation.

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The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 is a frequently used cancer-specific health-related quality of life (HRQoL) questionnaire. To aid interpretation of data obtained via EORTC QLQ-C30, general population norm data have been published for many countries. However, despite its frequent use in the United States, no normative data by sex and age exist to date. Therefore, this study aimed to generate sex- and age-specific EORTC QLQ-C30 normative data for the United States.
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Among trial participants (niraparib, n = 487; placebo, n = 246), PRO adherence exceeded 80% for all instruments across all cycles. Patients reported no decline over time in HRQoL measured via EORTC QLQ-C30 Global Health Status/QoL and FOSI overall scores. Scores for abdominal/gastrointestinal symptoms (EORTC QLQ-OV28) and nausea and vomiting, appetite loss, and constipation (EORTC QLQ-C30) were higher (worse symptoms) in niraparib-treated patients than placebo-treated patients; except for constipation, these differences resolved over time. Patients did not self-report any worsening from baseline of fatigue, headache, insomnia, or abdominal pain on questionnaires.
Despite some early, largely transient increases in gastrointestinal symptoms, patients with OC treated with niraparib first-line maintenance therapy reported no worsening in overall HRQoL.
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Cancer and its treatments significantly impact individuals’ lives and quality of life (QOL). Research on QOL examines these effects, encompassing physical, psychological, and social aspects. Understanding QOL factors is vital for both patients and clinicians. The evaluation of QOL of patients with cancer and its associated predictive factors has not been previously investigated within the Beni Mellal-Khenifra region of Morocco. Our primary aim was to assess the QOL experienced by patients while simultaneously identifying the determinants and predictors influencing it.
Patients were enrolled in a cross-sectional study conducted at the Beni Mellal Oncology Center. Each participant was required to fill out the Moroccan Arabic version of the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire, along with a supplemental questionnaire gathering sociodemographic information. A linear regression analysis was executed to ascertain predictors of the Global Health Status (GHS) and 5 functional scales. The statistical analysis was carried out using Statistical Package for Social Science (SPSS) v25 software.
Our study included 369 patients, with an average age of 52.89. The mean score on the QLQC30 GHS Scale was 64.97. Notably, this score exhibited positive correlations with emotional, social, and role functioning scales, while demonstrating negative correlations with prostate and lung cancers, as well as the presence of pain. Furthermore, the presence of fatigue exhibited associations with all functioning scales, except for social functioning.
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Out of the 1600 registered patients, 658 were treated for oligometastatic PCa, of which 233 had baseline QoL data and 132 patients had both baseline and follow-up HRQoL data. At baseline, most patients had a WHO performance status of 0 or 1 (87 %), were de-novo oligometastatic (79 %), had one metastasis (90 %), and had a good overall global health status (mean 80.81, SD16.11, IQR 75–92). 51 % received hormonal therapy as concomitant systemic treatment. Patients with comorbidities as assessed by the Charlson Comorbidity index had a worse global health status at baseline (-4.88, 95 % CI:-9.35, −0.42). No clinically meaningful significant difference in global health status was observed at first assessment following SBRT (median 3.0 months) compared with baseline (mean difference 2.27, 95 % CI:-1.54, 6.08). Upon evaluating the proportions, meaningful clinically important differences (a 10-point or more difference) was observed in, 17 % and 11 % of the patients reporting deterioration and improvement of global health status, respectively.
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To investigate the impact of the surgical extent on late adverse effects (LAE) following cytoreductive surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC).
A prospective cohort study including patients undergoing CRS + HIPEC due to peritoneal metastases from gastrointestinal tumour origin. From 2006 through 2019, consecutive patients treated with CRS + HIPEC were followed at 3, 6 and 12 months, and LAEs were assessed using the symptom scales and items from the European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC QLQ-C30). Surgical extent was categorized into three groups (major, intermediate, minor) based on peritonectomy procedures and colorectal resections performed as part of CRS. EORTC data were analysed using a linear mixed effects regression model adjusted for age, gender, origin of tumour and comorbidity.
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^☆: The study was supported by grants from the Danish Cancer Society. At the time that this study was conducted, Mirjam Sprangers was on the staff of the Division of Psychosocial Research and Epidemiology, the Netherlands Cancer Institute, and was supported by a grant from the Dutch Cancer Society (NKI-90A).

^☆☆: Elements from this manuscript were originally proposed by M. Groenvold to K. Avlund and were used in K. Avlund et al.'s article, “Are Self-Ratings of Functional Ability Reliable?”.

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Original articleValidation of the EORTC QLQ-C30 quality of life questionnaire through combined qualitative and quantitative assessment of patient-observer agreement☆,☆☆

Abstract

J Clin Epidemiol

J Clin Epidemiol

J Chron Dis

J Clin Epidemiol

J Clin Epidemiol

Who should measure quality of life, the doctor or the patient?

Br J Cancer

How to develop and validate a new quality of life instrument

A modular approach to quality-of-life assessment in cancer clinical trials

Recent Results Cancer Res

The EORTC Core Quality- of-Life Questionnaire: Interim results of an international field study

The European Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology

J Natl Cancer Inst

Psychometric validation of the EORTC core quality of life questionnaire, 30-item version and a diagnosis-specific module for head and neck cancer patients

Acta Oncol

Original article
Validation of the EORTC QLQ-C30 quality of life questionnaire through combined qualitative and quantitative assessment of patient-observer agreement☆,☆☆