The European Organization for Research and Treatment of Cancer QLQ-C30: A Quality-of-Life Instrument for Use in International Clinical Trials in Oncology
Identifieur interne : 00D835 ( Main/Exploration ); précédent : 00D834; suivant : 00D836The European Organization for Research and Treatment of Cancer QLQ-C30: A Quality-of-Life Instrument for Use in International Clinical Trials in Oncology
Auteurs : Neil K. Aaronson [Pays-Bas] ; Sam Ahmedzai [Royaume-Uni] ; Bengt Bergman [Suède] ; Monika Bullinger [Allemagne] ; Ann Cull [Royaume-Uni] ; Nicole J. Duez [Belgique] ; Antonio Filiberti [Italie] ; Henning Flechtner [Allemagne] ; Stewart B. Fleishman ; Johanna C. J. M. De Haes [Pays-Bas] ; Stein Kaasa [Norvège] ; Marianne Klee [Danemark] ; David Osoba [Canada] ; Darius Razavi [Belgique] ; Peter B. Rofe [Australie] ; Simon Schraub ; Kommer Sneeuw ; Marianne Sullivan [Suède] ; Fumikazu TakedaSource :
- JNCI: Journal of the National Cancer Institute [ 0027-8874 ] ; 1993-03-03.
Abstract
Background: In 1986, the European Organization for Research and Treatment of Cancer (EORTC) initiated a research program to develop an integrated, modular approach for evaluating the quality of life of patients participating in international clinical trials. Purpose: We report here the results of an international field study of the practicality, reliability, and validity of the EORTC QLQ-C30, the current core questionnaire. The QLQ-C30 incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. Several single-item symptom measures are also included. Methods: The questionnaire was administered before treatment and once during treatment to 305 patients with nonresectable lung cancer from centers in 13 countries. Clinical variables assessed included disease stage, weight loss, performance status, and treatment toxicity. Results: The average time required to complete the questionnaire was approximately 11 minutes, and most patients required no assistance. The data supported the hypothesized scale structure of the questionnaire with the exception of role functioning (work and household activities), which was also the only multi-item scale that failed to meet the minimal standards for reliability (Cronbach's alpha coefficient >.70) either before or during treatment. Validity was shown by three findings. First, while all interscale correlations were statistically significant, the correlation was moderate, indicating that the scales were assessing distinct components of the quality-of-life construct. Second, most of the functional and symptom measures discriminated clearly between patients differing in clinical status as defined by the Eastern Cooperative Oncology Group performance status scale, weight loss, and treatment toxicity. Third, there were statistically significant changes, in the expected direction, in physical and role functioning, global quality of life, fatigue, and nausea and vomiting, for patients whose performance status had improved or worsened during treatment. The reliability and validity of the questionnaire were highly consistent across the three language-cultural groups studied: patients from English-speaking countries, Northern Europe, and Southern Europe. Conclusions: These results support the EORTC QLQ-C30 as a reliable and valid measure of the quality of life of cancer patients in multicultural clinical research settings. Work is ongoing to examine the performance of the questionnaire among more heterogenous patient samples and in phase II and phase III clinical trials. [J Natl Cancer Inst 85: 365-376, 1993]
Url:
DOI: 10.1093/jnci/85.5.365
Affiliations:
- Allemagne, Australie, Belgique, Canada, Danemark, Italie, Norvège, Pays-Bas, Royaume-Uni, Suède
- Angleterre, Australie-Méridionale, Hollande-Septentrionale, Écosse
- Amsterdam
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Aaronson</name><affiliation wicri:level="3"><country>Pays-Bas</country><placeName><settlement type="city">Amsterdam</settlement><region nuts="2" type="province">Hollande-Septentrionale</region></placeName><wicri:orgArea>Division of Psychosocial Research and Epidemiology</wicri:orgArea></affiliation><affiliation wicri:level="1"><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Correspondence to: Neil K. Aaronson, Ph.D., Division of Psychosocial Research and Epidemiology. The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX Amsterdam</wicri:regionArea><wicri:noRegion>1066 CX Amsterdam</wicri:noRegion></affiliation></author><author><name sortKey="Ahmedzai, Sam" sort="Ahmedzai, Sam" uniqKey="Ahmedzai S" first="Sam" last="Ahmedzai">Sam Ahmedzai</name><affiliation wicri:level="2"><country>Royaume-Uni</country><placeName><region type="country">Angleterre</region></placeName><wicri:cityArea>The Leicestershire Hospice Leicester</wicri:cityArea></affiliation></author><author><name sortKey="Bergman, Bengt" sort="Bergman, Bengt" uniqKey="Bergman B" first="Bengt" last="Bergman">Bengt Bergman</name><affiliation wicri:level="1"><country xml:lang="fr">Suède</country><wicri:regionArea>Renstromska Hospital Göteborg</wicri:regionArea></affiliation></author><author><name sortKey="Bullinger, Monika" sort="Bullinger, Monika" uniqKey="Bullinger M" first="Monika" last="Bullinger">Monika Bullinger</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Biometric Center for Therapeutic Studies</wicri:regionArea></affiliation></author><author><name sortKey="Cull, Ann" sort="Cull, Ann" uniqKey="Cull A" first="Ann" last="Cull">Ann Cull</name><affiliation wicri:level="2"><country>Royaume-Uni</country><placeName><region type="country">Écosse</region></placeName><wicri:cityArea>Imperial Cancer Research Fund (ICRF) Medical Oncology Unit Edinburgh</wicri:cityArea></affiliation></author><author><name sortKey="Duez, Nicole J" sort="Duez, Nicole J" uniqKey="Duez N" first="Nicole J." last="Duez">Nicole J. Duez</name><affiliation wicri:level="1"><country xml:lang="fr">Belgique</country><wicri:regionArea>EORTC Central Office and Data Center Brussels</wicri:regionArea></affiliation></author><author><name sortKey="Filiberti, Antonio" sort="Filiberti, Antonio" uniqKey="Filiberti A" first="Antonio" last="Filiberti">Antonio Filiberti</name><affiliation wicri:level="1"><country xml:lang="fr">Italie</country><wicri:regionArea>Istituto Nazionale Tumori Milan</wicri:regionArea></affiliation></author><author><name sortKey="Flechtner, Henning" sort="Flechtner, Henning" uniqKey="Flechtner H" first="Henning" last="Flechtner">Henning Flechtner</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>University of Cologne</wicri:regionArea></affiliation></author><author><name sortKey="Fleishman, Stewart B" sort="Fleishman, Stewart B" uniqKey="Fleishman S" first="Stewart B." last="Fleishman">Stewart B. Fleishman</name><affiliation><wicri:noCountry code="subField">B)</wicri:noCountry></affiliation></author><author><name sortKey="Haes, Johanna C J M De" sort="Haes, Johanna C J M De" uniqKey="Haes J" first="Johanna C. J. M. De" last="Haes">Johanna C. J. M. De Haes</name><affiliation wicri:level="1"><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Academic Medical Center</wicri:regionArea></affiliation></author><author><name sortKey="Kaasa, Stein" sort="Kaasa, Stein" uniqKey="Kaasa S" first="Stein" last="Kaasa">Stein Kaasa</name><affiliation wicri:level="1"><country xml:lang="fr">Norvège</country><wicri:regionArea>The Norwegian Radium Hospital Oslo</wicri:regionArea></affiliation></author><author><name sortKey="Klee, Marianne" sort="Klee, Marianne" uniqKey="Klee M" first="Marianne" last="Klee">Marianne Klee</name><affiliation wicri:level="1"><country xml:lang="fr">Danemark</country><wicri:regionArea>Rigshospitalet</wicri:regionArea></affiliation></author><author><name sortKey="Osoba, David" sort="Osoba, David" uniqKey="Osoba D" first="David" last="Osoba">David Osoba</name><affiliation wicri:level="1"><country xml:lang="fr">Canada</country><wicri:regionArea>British Columbia Cancer Agency Vancouver</wicri:regionArea></affiliation></author><author><name sortKey="Razavi, Darius" sort="Razavi, Darius" uniqKey="Razavi D" first="Darius" last="Razavi">Darius Razavi</name><affiliation wicri:level="1"><country xml:lang="fr">Belgique</country><wicri:regionArea>Institut Jules Bordet Brussels</wicri:regionArea></affiliation></author><author><name sortKey="Rofe, Peter B" sort="Rofe, Peter B" uniqKey="Rofe P" first="Peter B." last="Rofe">Peter B. Rofe</name><affiliation wicri:level="2"><country>Australie</country><placeName><region type="state">Australie-Méridionale</region></placeName><wicri:cityArea>Royal Adelaide Hospital Adelaide</wicri:cityArea></affiliation></author><author><name sortKey="Schraub, Simon" sort="Schraub, Simon" uniqKey="Schraub S" first="Simon" last="Schraub">Simon Schraub</name><affiliation><wicri:noCountry code="no comma">Centre Hospitalier Régional de Besancon France</wicri:noCountry></affiliation></author><author><name sortKey="Sneeuw, Kommer" sort="Sneeuw, Kommer" uniqKey="Sneeuw K" first="Kommer" last="Sneeuw">Kommer Sneeuw</name><affiliation><wicri:noCountry code="no comma">The Netherlands Cancer Institute</wicri:noCountry></affiliation></author><author><name sortKey="Sullivan, Marianne" sort="Sullivan, Marianne" uniqKey="Sullivan M" first="Marianne" last="Sullivan">Marianne Sullivan</name><affiliation wicri:level="1"><country xml:lang="fr">Suède</country><wicri:regionArea>Sahlgrenska Hospital Göteborg</wicri:regionArea></affiliation></author><author><name sortKey="Takeda, Fumikazu" sort="Takeda, Fumikazu" uniqKey="Takeda F" first="Fumikazu" last="Takeda">Fumikazu Takeda</name><affiliation><wicri:noCountry code="no comma">Saitama Cancer Center Japan</wicri:noCountry></affiliation></author></analytic><monogr></monogr><series><title level="j">JNCI: Journal of the National Cancer Institute</title><idno type="ISSN">0027-8874</idno><idno type="eISSN">1460-2105</idno><imprint><publisher>Oxford University Press</publisher><date type="published" when="1993-03-03">1993-03-03</date><biblScope unit="volume">85</biblScope><biblScope unit="issue">5</biblScope><biblScope unit="page" from="365">365</biblScope><biblScope unit="page" to="376">376</biblScope></imprint><idno type="ISSN">0027-8874</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0027-8874</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract">Background: In 1986, the European Organization for Research and Treatment of Cancer (EORTC) initiated a research program to develop an integrated, modular approach for evaluating the quality of life of patients participating in international clinical trials. Purpose: We report here the results of an international field study of the practicality, reliability, and validity of the EORTC QLQ-C30, the current core questionnaire. The QLQ-C30 incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. Several single-item symptom measures are also included. Methods: The questionnaire was administered before treatment and once during treatment to 305 patients with nonresectable lung cancer from centers in 13 countries. Clinical variables assessed included disease stage, weight loss, performance status, and treatment toxicity. Results: The average time required to complete the questionnaire was approximately 11 minutes, and most patients required no assistance. The data supported the hypothesized scale structure of the questionnaire with the exception of role functioning (work and household activities), which was also the only multi-item scale that failed to meet the minimal standards for reliability (Cronbach's alpha coefficient >.70) either before or during treatment. Validity was shown by three findings. First, while all interscale correlations were statistically significant, the correlation was moderate, indicating that the scales were assessing distinct components of the quality-of-life construct. Second, most of the functional and symptom measures discriminated clearly between patients differing in clinical status as defined by the Eastern Cooperative Oncology Group performance status scale, weight loss, and treatment toxicity. Third, there were statistically significant changes, in the expected direction, in physical and role functioning, global quality of life, fatigue, and nausea and vomiting, for patients whose performance status had improved or worsened during treatment. The reliability and validity of the questionnaire were highly consistent across the three language-cultural groups studied: patients from English-speaking countries, Northern Europe, and Southern Europe. Conclusions: These results support the EORTC QLQ-C30 as a reliable and valid measure of the quality of life of cancer patients in multicultural clinical research settings. Work is ongoing to examine the performance of the questionnaire among more heterogenous patient samples and in phase II and phase III clinical trials. [J Natl Cancer Inst 85: 365-376, 1993]</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Belgique</li><li>Canada</li><li>Danemark</li><li>Italie</li><li>Norvège</li><li>Pays-Bas</li><li>Royaume-Uni</li><li>Suède</li></country><region><li>Angleterre</li><li>Australie-Méridionale</li><li>Hollande-Septentrionale</li><li>Écosse</li></region><settlement><li>Amsterdam</li></settlement></list><tree><noCountry><name sortKey="Fleishman, Stewart B" sort="Fleishman, Stewart B" uniqKey="Fleishman S" first="Stewart B." last="Fleishman">Stewart B. Fleishman</name><name sortKey="Schraub, Simon" sort="Schraub, Simon" uniqKey="Schraub S" first="Simon" last="Schraub">Simon Schraub</name><name sortKey="Sneeuw, Kommer" sort="Sneeuw, Kommer" uniqKey="Sneeuw K" first="Kommer" last="Sneeuw">Kommer Sneeuw</name><name sortKey="Takeda, Fumikazu" sort="Takeda, Fumikazu" uniqKey="Takeda F" first="Fumikazu" last="Takeda">Fumikazu Takeda</name></noCountry><country name="Pays-Bas"><region name="Hollande-Septentrionale"><name sortKey="Aaronson, Neil K" sort="Aaronson, Neil K" uniqKey="Aaronson N" first="Neil K." last="Aaronson">Neil K. Aaronson</name></region><name sortKey="Aaronson, Neil K" sort="Aaronson, Neil K" uniqKey="Aaronson N" first="Neil K." last="Aaronson">Neil K. Aaronson</name><name sortKey="Haes, Johanna C J M De" sort="Haes, Johanna C J M De" uniqKey="Haes J" first="Johanna C. J. M. De" last="Haes">Johanna C. J. M. De Haes</name></country><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Ahmedzai, Sam" sort="Ahmedzai, Sam" uniqKey="Ahmedzai S" first="Sam" last="Ahmedzai">Sam Ahmedzai</name></region><name sortKey="Cull, Ann" sort="Cull, Ann" uniqKey="Cull A" first="Ann" last="Cull">Ann Cull</name></country><country name="Suède"><noRegion><name sortKey="Bergman, Bengt" sort="Bergman, Bengt" uniqKey="Bergman B" first="Bengt" last="Bergman">Bengt Bergman</name></noRegion><name sortKey="Sullivan, Marianne" sort="Sullivan, Marianne" uniqKey="Sullivan M" first="Marianne" last="Sullivan">Marianne Sullivan</name></country><country name="Allemagne"><noRegion><name sortKey="Bullinger, Monika" sort="Bullinger, Monika" uniqKey="Bullinger M" first="Monika" last="Bullinger">Monika Bullinger</name></noRegion><name sortKey="Flechtner, Henning" sort="Flechtner, Henning" uniqKey="Flechtner H" first="Henning" last="Flechtner">Henning Flechtner</name></country><country name="Belgique"><noRegion><name sortKey="Duez, Nicole J" sort="Duez, Nicole J" uniqKey="Duez N" first="Nicole J." last="Duez">Nicole J. Duez</name></noRegion><name sortKey="Razavi, Darius" sort="Razavi, Darius" uniqKey="Razavi D" first="Darius" last="Razavi">Darius Razavi</name></country><country name="Italie"><noRegion><name sortKey="Filiberti, Antonio" sort="Filiberti, Antonio" uniqKey="Filiberti A" first="Antonio" last="Filiberti">Antonio Filiberti</name></noRegion></country><country name="Norvège"><noRegion><name sortKey="Kaasa, Stein" sort="Kaasa, Stein" uniqKey="Kaasa S" first="Stein" last="Kaasa">Stein Kaasa</name></noRegion></country><country name="Danemark"><noRegion><name sortKey="Klee, Marianne" sort="Klee, Marianne" uniqKey="Klee M" first="Marianne" last="Klee">Marianne Klee</name></noRegion></country><country name="Canada"><noRegion><name sortKey="Osoba, David" sort="Osoba, David" uniqKey="Osoba D" first="David" last="Osoba">David Osoba</name></noRegion></country><country name="Australie"><region name="Australie-Méridionale"><name sortKey="Rofe, Peter B" sort="Rofe, Peter B" uniqKey="Rofe P" first="Peter B." last="Rofe">Peter B. 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