The European Organization for Research and treatment of cancer approach to quality of life assessment: guidelines for developing questionnaire modules Special Report Received: 09 June 1993 Accepted: 09 June 1993 DOI:
Cite this article as: Sprangers, M.A.G., Cull, A., Bjordal, K. et al. Qual Life Res (1993) 2: 287. doi:10.1007/BF00434800 Abstract
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.
Keywords Quality of life assessment cross-cultural questionnaire construction
This work was supported, in part, by grants from the Dutch Cancer Society (NKI 90-A), the Imperial Cancer Research Fund (ICRF), and the Norwegian Cancer Society.
Bergner, M, Bobbit, RA, Carter, WB, Gilson, BS. The Sickness Impact Profile: Development and final revision of a health status measure.
Hunt, S, McKenna, SP, McEwen, J, et al. The Nottingham Health Profile: Subjective health status and medical consultations.
Soc Sci Med
Ware, JE, Sherbourne, CD. The MOS 36-Item Short-Form Health Survey (SF-36).
Meenan, RF, Gertman, PM, Mason, JH. Measuring health status in arthritis: The Arthritis Impact Measurement Scales.
Schipper, H, Clinch, J, McMurray, A. Measuring the quality of life of cancer patients: The Functional Living Index-Cancer: Development and validation.
J Clin Oncol
Schag, CC, Heinrich, RL.
The CAncer Rehabilitation Evaluation System (CARES)
. Manual. Los Angeles: CARES Consultants, 1989.
Aaronson, NK, Bullinger, M, Ahmedzai, SA. A modular approach to quality-of-life assessment in cancer clinical trials.
Rec Results in Cancer Res
Aaronson, NK, Ahmedzai, SA, Bergman, B, et al. The EORTC QLQ-C30: A quality of life instrument for use in international clinical trials in oncology.
J Natl Cancer Inst
Sprangers M, Cull A for the EORTC Study Group on Quality of Life.
Guidelines for Module Development. Amsterdam/Edinburgh: 1992, internal report.
Aaronson, NK, Ahmedzai, SA, Bullinger, M, et al. The EORTC Core Quality of Life Questionnaire: interim results of an international field study. In: Osoba, D (ed).
The Effect of Cancer on Quality of Life
. Boston: CRC Press. 1991: 185–204.
The Design and Understanding of Survey Questions
. Aldershot, England: Gower, 1982.
Converse JM, Presser S.
Survey Questions. Handcrafting the Standard Questionnaire. Sage University Paper (63). Beverly Hills, 1986.
Kornhauser, A, Sheatsley, PB. Questionnaire construction and interview procedure. In: Selltiz C, Wrightsman LS, Cook SW.
Research Methods in Social Relations
. Holt, Rhinehart and Winston. New York, 1976.
The Art of Asking Questions
. Princeton, NJ: Princeton University Press, 1951.
Schuman, H, Presser, S.
Questions and Answers in Attitude Surveys: Experiments of Question Form, Wording, and Context
. New York: Academic Press, 1981.
Studman, S, Bradburn, N.
Asking Questions: A Practical Guide to Questionnaire Design
. San Fransisco: Jossey-Bass, 1982.
Aaronson, NK, Acquadro, C, Alonso, J, et al. International quality of life assessment (IQOLA) project.
Quality Life Res
Hunt, SM. Cross-cultural issues in the use of sociomedical indicators.
European Group for Health Measurement and Quality of Life Assessment: Hunt SM, Alonso J, Bucquet D, Niero M, Wiklund I, McKenna S. Cross cultural adaptation of health measures.
Deyo, RA. Pitfalls in measuring the health status of Mexican Americans: Comparative validity of the English and Spanish Impact Profile.
Am J Public Health
Bjordal, K, Kaasa, S, Ahlner-Elmqvist, M, Tollesson, E, Bonde, A. Development of a head and neck cancer-specific module for use with the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30).
Quality Life Res.
Sprangers M, Groenvold M, te Velde A,
et al. for the EORTC Study Group on Quality of Life. The Construction of a Breast Cancer Module. Amsterdam: 1992, internal report.
Groenvold M. Quality of life in breast cancer adjuvant therapy. What should be measured? Poster presented at the ECCO-6, Florence, 1991.
Gilson, BS, Erickson, D, Chavez, CT, Bobbit, RA, Bergner, M, Carter, WB. A chicano version of the Sickness Impact Profile (SIP).
Culture Med Psychiatr
Jacobs, HM, Luttik, A, Touw-Otten, FWMM, Kastein, M, Melker, RAde. Measuring impact of sickness in patients with nonspecific abdominal complaints in a Dutch family practice setting.
Patrick, DL, Sittampalam, Y, Somerville, SM, Carter, WB, Bergner, M. A cross-cultural comparison of health status values.
Am J Publ Health
Hunt, SM, Wiklund, I. Cross-cultural variation in the weighting of health statements: a comparison of English and Swedish valuations.
Alonso, J, Anto, JM, Moreno, C. Spanish version of the Nottingham Health Profile: translation and preliminary validity.
Am J Publ Health
Preliminary Manual Functional Assessment of Cancer Therapy (FACT) Scales
. Rush-Presbyterian-St. Luke's Medical Center, 1992.
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