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      • Record: found
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      Is Open Access

      Responsiveness of EORTC QLQ-C30, QLQ-CR38 and FACT-C quality of life questionnaires in patients with colorectal cancer

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          Abstract

          Background

          The aim of this study was to compare the responsiveness of the European Organization for Research and Treatment (EORTC) quality of life questionnaires (QLQ-C30, QLQ-CR38) and the Functional Assessment of Cancer Therapy-colorectal version 4 questionnaire (FACT-C).

          Method

          This prospective study included 127 patients with colorectal cancer: 71 undergoing chemotherapy and 56 radiation therapy. Responsiveness statistics included the Standardized Response Mean (SRM) and the Effect Size (ES). The patient's overall assessment of his/her change in state of health status was the reference criterion to evaluate the responsiveness of the QoL questionnaires.

          Results

          34 patients perceived their health as stable and 17 as improved between the first and the fourth courses of chemotherapy. 21 patients perceived their health as stable and 22 as improved between before and the last week of radiotherapy.

          The responsiveness of the 3 questionnaires differed according to treatments. The EORTC QLQ-C30 questionnaire was more responsive in patients receiving chemotherapy, particulary functional scales (SRM > 0.55). The QLQ-CR38 and the FACT-C questionnaires provided little clinically relevant information during chemotherapy or radiotherapy.

          Conclusion

          The EORTC QLQ-C30 questionnaire appears to be more responsive in patients receiving chemotherapy.

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          Most cited references24

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          Measurement of health status. Ascertaining the minimal clinically important difference.

          R Jaeschke, J Singer, G H Guyatt (1989)
          In recent years quality of life instruments have been featured as primary outcomes in many randomized trials. One of the challenges facing the investigator using such measures is determining the significance of any differences observed, and communicating that significance to clinicians who will be applying the trial results. We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change. Using this approach we have established a plausible range within which the minimal clinically important difference (MCID) falls. In three studies in which instruments measuring dyspnea, fatigue, and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item, when responses were presented on a seven point Likert scale. Furthermore, we have established ranges for changes in questionnaire scores that correspond to moderate and large changes in the domains of interest. This information will be useful in interpreting questionnaire scores, both in individuals and in groups of patients participating in controlled trials, and in the planning of new trials.
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            Interpreting the significance of changes in health-related quality-of-life scores.

            J. R. Pater, Barry Zee, Acácio Rodrigues … (1997)
            To determine the significance to patients of changes in health-related quality-of-life (HLQ) scores assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30). A subjective significance questionnaire (SSQ), which asks patients about perceived changes in physical, emotional, and social functioning and in global quality of life (global QL) and the QLQ-C30 were completed by patients who received chemotherapy for either breast cancer or small-cell lung cancer (SCLC). In the SSQ, patients rated their perception of change since the last time they completed the QLQ-C30 using a 7-category scale that ranged from "much worse" through "no change" to "much better." For each category of change in the SSQ, the corresponding differences were calculated in QLQ-C30 mean scores and effect sizes were determined. For patients who indicated "no change" in the SSQ, the mean change in scores in the corresponding QLQ-C30 domains was not significantly different from 0. For patients who indicated "a little" change either for better or for worse, the mean change in scores was about 5 to 10; for "moderate" change, about 10 to 20; and for "very much" change, greater than 20. Effect sizes increased in concordance with increasing changes in SSQ ratings and QLQ-C30 scores. The significance of changes in QLQ-C30 scores can be interpreted in terms of small, moderate, or large changes in quality of life as reported by patients in the SSQ. The magnitude of these changes also can be used to calculate the sample sizes required to detect a specified change in clinical trials.
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              Integrating response shift into health-related quality of life research: a theoretical model.

              M A G Sprangers, C E Schwartz (1999)
              Patients confronted with a life-threatening or chronic disease are faced with the necessity to accommodate to their illness. An important mediator of this adaptation process is 'response shift' which involves changing internal standards, values and the conceptualization of quality of life (QOL). Integrating response shift into QOL research would allow a better understanding of how QOL is affected by changes in health status and would direct the development of reliable and valid measures for assessing changes in QOL. A theoretical model is proposed to clarify and predict changes in QOL as a result of the interaction of: (a) a catalyst, referring to changes in the respondent's health status; (b) antecedents, pertaining to stable or dispositional characteristics of the individual (e.g. personality); (c) mechanisms, encompassing behavioral, cognitive, or affective processes to accommodate the changes in health status (e.g. initiating social comparisons, reordering goals); and (d) response shift, defined as changes in the meaning of one's self-evaluation of QOL resulting from changes in internal standards, values, or conceptualization. A dynamic feedback loop aimed at maintaining or improving the perception of QOL is also postulated. This model is illustrated and the underlying assumptions are discussed. Future research directions are outlined that may further the investigation of response shift, by testing specific hypotheses and predictions about the QOL domains and the clinical and psychosocial conditions that would potentiate or prevent response shift effects.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Health Qual Life Outcomes
                Title: Health and Quality of Life Outcomes
                Publisher: BioMed Central
                ISSN (Electronic): 1477-7525
                Publication date Collection: 2011
                Publication date (Electronic): 22 August 2011
                Volume: 9
                Page: 70
                Affiliations
                [1 ]Centre Alexis Vautrin, Department of Medical Oncology, Nancy, France
                [2 ]Nancy-University, Paul Verlaine Metz University, Paris Descartes University, EA 4360 Apemac, Nancy, France
                [3 ]INSERM, CIC-EC CIE6, Nancy, France
                [4 ]Quality of Life in oncology platform, Canceropole Grand-Est, Nancy, France
                [5 ]University hospital Jean Minjoz, Department of Radiation Oncology, Besançon, France
                [6 ]Medical and Pharmaceutical University, Department of Biostatistics, Besançon, France
                [7 ]Centre Alexis Vautrin, Department of Radiation Oncology, Nancy, France
                [8 ]Clinique Saint-Vincent, Medical Oncology, Besançon, France
                [9 ]Centre Alexis Vautrin, Department of Surgery, Nancy, France
                Article
                Publisher ID: 1477-7525-9-70
                DOI: 10.1186/1477-7525-9-70
                PMC ID: 3170175
                PubMed ID: 21859485
                SO-VID: 49e2d3f2-408a-40e7-ad12-dd7a30ea007e
                Copyright © Copyright ©2011 Uwer et al; licensee BioMed Central Ltd.
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 11 April 2011
                Date accepted : 22 August 2011
                Categories
                Subject: Research

                ScienceOpen disciplines: Health & Social care
                Keywords: fact-c,responsiveness,eortc qlq-c30,quality of life,eortc qlq-cr38,colorectal cancer
                Data availability:
                ScienceOpen disciplines: Health & Social care
                Keywords: fact-c, responsiveness, eortc qlq-c30, quality of life, eortc qlq-cr38, colorectal cancer

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