Kristin Bjordal

Quality of Life in Head and Neck Cancer Patients: Validation of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-H&N35

PURPOSE The aim of this study was to define the scales and test the validity, reliability, and sensitivity of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N35, a questionnaire designed to assess the quality of life of head and neck (H&N) cancer patients in conjunction with the general cancer-specific EORTC QLQ-C30. PATIENTS AND METHODS Questionnaires were given to 500 H&N cancer patients from Norway, Sweden, and the Netherlands as part of two prospective studies. The patients completed the questionnaires before, during (Norway and Sweden only), and after treatment, yielding a total of 2070 completed questionnaires. RESULTS The compliance rate was high, and the questionnaires were well accepted by the patients. Seven scales were constructed (pain, swallowing, senses, speech, social eating, social contact, sexuality). Scales and single items were sensitive to differences between patient subgroups with relation to site, stage, or performance status. Most scales and single items were sensitive to changes, with differences of various magnitudes according to the site in question. The internal consistency, as assessed by Cronbachs alpha coefficient, varied according to assessment point and within subsamples of patients. A low overall alpha value was found for the speech and the senses scales, but values were higher in assessments of patients with laryngeal cancer and in patients with nose, sinus, and salivary gland tumors. Scales and single items in the QLQ-H&N35 seem to be more sensitive to differences between groups and changes over time than do the scales and single items in the core questionnaire. CONCLUSION The QLQ-H&N35, in conjunction with the QLQ-C30, provides a valuable tool for the assessment of health-related quality of life in clinical studies of H&N cancer patients before, during, and after treatment with radiotherapy, surgery, or chemotherapy.

A 12 country field study of the EORTC QLQ-C30 (version 3.0) and the head and neck cancer specific module (EORTC QLQ-H&N35) in head and neck patients

This study tests the reliability and validity of the European Organization for Research and Treatment of Cancer (EORTC) head and neck cancer module (QLQ-H&N35) and version 3.0 of the EORTC Core Questionnaire (QLQ-C30) in 622 head and neck cancer patients from 12 countries. The patients completed the QLQ-C30, the QLQ-H&N35 and a debriefing questionnaire before antineoplastic treatment or at a follow-up. 232 patients receiving treatment completed a second questionnaire after treatment. Compliance was high and the questionnaire was well accepted by the patients. Multitrait scaling analysis confirmed the proposed scale structure of the QLQ-H&N35. The QLQ-H&N35 was responsive to differences between disease status, site and patients with different Karnofsky performance status, and to changes over time. The new physical functioning scale (with a four-point response format) of version 3.0 of the QLQ-C30 was shown to be more reliable than previous versions. Thus, the QLQ-H&N35, in conjunction with the QLQ-C30, appears to be reliable, valid and applicable to broad multicultural samples of head and neck cancer patients.

The European Organization for Research and treatment of cancer approach to quality of life assessment: guidelines for developing questionnaire modules

The EORTC Study Group on Quality of Life (the Study Group) has adopted a modular approach to quality of life (QOL) assessment in cancer clinical trials. A ‘core’ instrument—the QLQ-C30—has been designed to cover a range of QOL issues relevant to a broad spectrum of cancer patients. It is intended that this QLQ-C30 be supplemented by more specific subscales (‘modules’) to assess aspects of QOL of particular importance to specific subgroups of patients. Since individual members of the Study Group were to be involved in module development, guidelines were required to standardize the module development process in order to ensure uniformly high quality across modules. These guidelines are presented in this paper. The term ‘module’ is defined, the composition of modules is outlined, and the criteria used to develop modules are specified. The module development process, consisting of four phases (generation of relevant QOL issues, operationalization of the QOL issues into a set of items, pretesting the module questionnaire, and large-scale field-testing) is described in detail. Further, issues related to cross-cultural instrument development, and the need for monitoring the module development process from within the Study Group are discussed. Finally, experiences with developing two site-specific modules (i.e., for head and neck, and breast cancer), are presented and the extent to which the guidelines meet practical requirements is discussed. The guidelines appear to provide a practical tool for module construction, that can facilitate the development of a comprehensive system for assessing the QOL of cancer patients internationally.

Psychometric Validation of the Eortc Core Quality of Life Questionnaire, 30-Item Version and A Diagnosis-Specific Module for Head and Neck Cancer Patients

A cancer-specific self-reporting quality of life questionnaire has been validated. The questionnaire is designed to assess physical functioning, role functioning, cognitive functioning, emotional functioning, social functioning, pain, fatigue, emesis and quality of life by means of multi-item scales, and other disease- and treatment-related symptoms by means of single items. The questionnaire was completed by 126 head and neck cancer patients with a mean age of 67 years. The internal consistency (scale reliability) was satisfactory for all scales but one. Correlations between scales and items assessing the same underlying dimension were also satisfactory. The questionnaire discriminates between patient subgroups and between acute, subacute and late toxicity. Patient compliance was high. The questionnaire provided valuable information, and most of the scales/items functioned well. A few problems were found, especially with the modified visual analogue scales, and minor modifications will be made.

Development of a European Organization for Research and Treatment of Cancer (Eortc) Questionnaire Module to be Used in Quality of Life Assessments in Head and Neck Cancer Patients

A head and neck cancer specific questionnaire module designed to be used in quality of life assessments before, during, and after radiotherapy and surgery, with or without combinations with chemotherapy has been developed in accordance with guidelines given by the EORTC Quality of Life Study Group. Relevant issues were generated by means of literature search, and interviews with specialists and patients. Pre-testing of a preliminary questionnaire module was performed in patients from Norway, Sweden, Denmark, United Kingdom and French-speaking Belgium. The resulting head and neck cancer module, the EORTC QLQ-H&N37, includes 37 items concerning disease and treatment related symptoms, social function and sexuality. By using a combination of the general EORTC QLQ-C30 and the EORTC QLQ-H&N37, health-related quality of life measurements may be compared between studies in different cancer populations, and still be sensitive to changes in the target population.

Test/retest study of the European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire.

PURPOSE The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) is a well-validated instrument that assesses health-related quality of life (HRQOL) in cancer patients. It is used in cancer clinical trials in Europe, Canada, and the United States, and has demonstrated high reliability and validity in different groups of cancer patients. Despite thorough testing of reliability and validity, we have not identified any reports on its test/retest reliability; thus, a test/retest study was performed at the Norwegian Radium Hospital (NRH). MATERIALS AND METHODS Cancer patients from the outpatient clinic who were off treatment for > or = 3 months were eligible for the study. The EORTC QLQ-C30 was given to the patients when they presented for their visit. The second questionnaire was received by the patients 4 days later. Of 291 eligible patients, 270 (93%) agreed to participate and 190 (73%) completed both questionnaires. RESULTS The test/retest reliability measured by Pearsons correlation coefficient was high for all functional scales, with a range from .82 for cognitive and role function to .91 for physical function. The r value for global HRQOL was .85. For the symptom scales--nausea/vomiting, fatigue, and pain--the coefficients were .63, .83, and .86, respectively. The single-item coefficients ranged from .72 for diarrhea to .84 for financial impact. The Spearman rank correlation was in the same range for all dimensions. CONCLUSION The EORTC QLQ-C30 seems to yield high test/retest reliability in patients with various cancer diagnoses whose condition is not expected to change during the time of measurement.

Health-related quality of life in the general Norwegian population assessed by the European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire: The QLQ=C30 (+ 3)

PURPOSE To obtain reference data on health-related quality of life (HRQOL) for the functional and symptom scales and single items of the European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire (EORTC QLQ-C30 [+ 3]) in a representative sample of the Norwegian general population. PATIENTS AND METHODS A randomly selected sample of 3,000 people from the Norwegian population, aged 18 to 93 years, who represent geographic diversity, took part in this postal survey. The EORTC QLQ-C30 (+ 3) and a questionnaire about demographic data and health were sent by mail. A new questionnaire package was sent as a reminder after 3 weeks. RESULTS The survey yielded a high response rate with 1,965 of 2,892 eligible persons responding (68%). There was a low amount of missing data (1.8%). Internal consistency was highly satisfactory and yielded Cronbachs alpha coefficients greater than 0.70 for all but two functional scales and one symptom scale. The sensitivity of the questionnaire was shown by the excellent discrimination between age and sex groups. Clinical validity was shown by the distinct differences according to age and sociodemographic characteristics. Women reported lower functional status and global quality of life (mean scale scores from 71.7 to 91.0) than men (mean scale scores from 75.4 to 94.4), and also more symptoms and problems. This was remarkably consistent across age groups, as was a decline in functional status with an increase in age. CONCLUSION This is the first study that presented reference data from the EORTC QLQ-C30 (+ 3) in a sample from a general population and seems to provide valid measures of HRQOL within different age groups. The results may serve as a guideline for clinicians when interpreting HRQOL in their own groups of patients, and contributes to a better understanding of the significance of mean scores and their clinical relevance.

Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system.

There is need for multilingual cross-culturally valid quality of life (QOL) instrumentation to assess the QOL endpoint in international oncology clinical trials. We therefore initiated a multilingual translation of the Functional Assessment of Cancer Therapy (FACT) Quality of Life Measurement System (Version 3) into the following languages: Dutch, French, German, Italian, Norwegian and Swedish. Prior to this project, the FACT Measurement System was available in English, Spanish and Canadian French. The FACT is a self-report instrument which measures multidimensional QOL. The FACT (Version 3) evaluation system uses a 29–49 item compilation of a generic core (29 Likert-type items) and numerous subscales (9–20 items each) which reflect symptoms associated with different diseases, symptom complexes and treatments. The FACT-G (general version) and eight of 18 available cancer-related subscales were translated using an iterative forward-backward translation sequence. After subsequent review by 21 bilingual health professionals, all near final language versions underwent pretesting with a total of 95 patients in the native countries. Available results indicate good overall comprehensibility among native language-speakers. Equivalent foreign language versions of the FACT will permit QOL evaluation of people from diverse cultural backgrounds.

A Prospective Study of Quality of Life in Head and Neck Cancer Patients. Part II: Longitudinal Data†

Objectives To evaluate the health‐related quality of life (HRQL) of patients with head and neck cancer during and after treatment with radiotherapy, surgery, and chemotherapy.

The European organization for research and treatment of cancer approach to developing questionnaire modules: an update and overview

The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Study Group has adopted a modular approach to quality of life (QoL) assessment in cancer clinical trials. The core instrument (the EORTC QLQ-C30) covers a range of QoL issues relevant to a broad spectrum of patients with cancer. The QLQ-C30 is designed to be supplemented by more specific subscales (‘modules’) to assess aspects of QoL of particular importance to specific subgroups of patients. Since individual members of the study group were to be involved in module development, guidelines were established. The primary aim of these guidelines was to standardize the module development process in order to ensure uniformly high quality across modules. This paper gives an update of the work completed to date. First, while the guidelines proved practical for module development, producing modules that exhibit adequate levels of psychometric and cross-cultural validity, experience pointed to three areas where the guidelines required more precision. These amendments will be provided and include (1) stricter monitoring of the developmental process from within the study group, (2) the explicit requirement of involvement of the study group and (3) a more precise definition of the criteria to be fulfilled before modules are allowed to be called ‘EORTC modules’. Second, an overview of the modules currently under development or available for general use is provided. These modules include those for body image, high-dose chemotherapy, leukaemia, myeloma, palliative care and the following cancers: bladder, brain, breast, colorectal, head and neck, lung, oesophageal, ophthalmic, ovarian, pancreas and prostate. Finally, the need for the coordination of efforts in module development, both from within and outside the EORTC, is discussed.