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Quality of Life Research
Gepubliceerd in: Quality of Life Research 3/2019

03-12-2018

Determining clinically important differences in health-related quality of life in older patients with cancer undergoing chemotherapy or surgery

Auteurs: C. Quinten, C. Kenis, L. Decoster, P. R. Debruyne, I. De Groof, C. Focan, F. Cornelis, V. Verschaeve, C. Bachmann, D. Bron, S. Luce, G. Debugne, H. Van den Bulck, J. C. Goeminne, A. Baitar, K. Geboers, B. Petit, C. Langenaeken, R. Van Rijswijk, P. Specenier, G. Jerusalem, J. P. Praet, K. Vandenborre, M. Lycke, J. Flamaing, K. Milisen, J. P. Lobelle, H. Wildiers

Gepubliceerd in: Quality of Life Research | Uitgave 3/2019

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Abstract

Purpose

Using the EORTC Global Health Status (GHS) scale, we aimed to determine minimal clinically important differences (MCID) in health-related quality of life (HRQOL) changes for older cancer patients with a geriatric risk profile, as defined by the geriatric 8 (G8) health screening tool, undergoing treatment. Simultaneously, we assessed baseline patient characteristics prognostic for HRQOL changes.

Methods

Our analysis included 1424 (G8 ≤ 14) older patients with cancer scheduled to receive chemotherapy (n = 683) or surgery (n = 741). Anchor-based methods, linking the GHS score to clinical indicators, were used to determine MCID between baseline and follow-up at 3 months. A threshold of 0.2 standard deviation (SD) was used to exclude MCID estimates too small for interpretation. Logistic regressions analysed baseline patient characteristics prognostic for HRQOL changes.

Results

The 15-item Geriatric Depression Scale (GDS15), Visual Analogue Scale (VAS) for Fatigue and ECOG Performance Status (PS) were selected as clinical anchors. In the surgery group, MCID estimates for improvement and deterioration were ECOG PS (5*, 11*), GDS15 (5*, 2) and VAS Fatigue (3, 9*). In the chemotherapy group, MCID estimates for improvement and deterioration were ECOG PS (8*, 7*), GDS15 (5, 4) and VAS Fatigue (5, 5*). Estimates with * were > 0.2 SD threshold. Patients experiencing pain or malnutrition (surgery group) or fatigue (chemotherapy group) at baseline showed a significantly stable or improved HRQOL (p < 0.05) after their treatment.

Conclusion

The reported MCID for improvement and deterioration depended on the anchor used and treatment received. The estimates can be used to evaluate significant changes in HRQOL and to determine sample sizes in clinical trials.
vorige artikel Pre-injury health status of injured patients: a prospective comparison with the Dutch population
volgende artikel Early quality-of-life and psychological predictors of disease-free time and survival in localized prostate cancer
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Literatuur
1.
Zikos, E., Coens, C., Quinten, C., Ediebah, D. E., Martinelli, F., Ghislain, I., et al. (2016). The added value of analyzing pooled health-related quality of life data: A review of the EORTC PROBE initiative. Journal of the National Cancer Institute, 108(5), djv391.CrossRefPubMed
2.
King, M. T. (2011). A point of minimal important difference (MID): A critique of terminology and methods. Expert Review of Pharmacoeconomics & Outcomes Research, 11(2), 171.CrossRef
3.
Kane, R. C. (2008). The clinical significance of statistical significance. The Oncologist, 13(11), 1129–1133.CrossRefPubMed
4.
Revicki, D., Hays, R. D., Cella, D., & Sloan, J. (2008). Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. Journal of Clinical Epidemiology, 61(2), 102–109.CrossRefPubMed
5.
Terwee, C. B., Roorda, L. D., Dekker, J., Bierma-Zeinstra, S. M., Peat, G., Jordan, K. P., et al. (2010). Mind the MIC: Large variation among populations and methods. Journal of Clinical Epidemiology, 63(5), 524–534.CrossRefPubMed
6.
Wright, A., Hannon, J., Hegedus, E. J., & Kavchak, A. E. (2012). Clinimetrics corner: A closer look at the minimal clinically important difference (MCID). Journal of Manual & Manipulative Therapy, 20(3), 160–166.CrossRef
7.
Bedard, G., Zeng, L., Zhnag, L., Lauzon, N., Holden, L., Tsao, M., et al. (2014). Minimal important differences in the EORTC QLQ-C30 in patients with advanced cancer. Asia-Pacific Journal of Clinical Oncology, 10(2), 109–117.CrossRefPubMed
8.
Boyce, M. B., Browne, J. P., & Greenhalgh, J. (2014). The experiences of professionals with using information from patient-reported outcome measures to improve the quality of healthcare: A systematic review of qualitative research. BMJ Quality Safety, 23(6), 508–518.CrossRefPubMed
9.
10.
Osoba, D., Rodrigues, G., Myles, J., Zee, B., & Pater, J. (1998). Interpreting the significance of changes in health related quality of life scores. Journal of Clinical Oncology, 16(1), 139–144.CrossRefPubMed
11.
King, M. T. (1996). The interpretation of scores form the EORTC quality of life questionnaire QLQ-C30. Quality of Life Research, 5(6), 555–567.CrossRefPubMed
12.
Bedard, G., Zeng, L., Lam, H., Cella, D., Zhang, L., Lauzon, N., et al. (2012). Meaningful change in oncology quality-of-life instruments: A systematic literature review. Expert Review of Pharmacoeconomics & Outcomes Research, 12(4), 475–483.CrossRef
13.
14.
Coens, C., van der Graaf, W. T. A., Blay, J. Y., Chawla, S. P., Judson, I., Sanfilippo, R., et al. (2015). Health-related quality-of-life results from PALETTE: A randomized, double-blind, phase 3 trial of pazopanib versus placebo in patients with soft tissue sarcoma whose disease has progressed during or after prior chemotherapy-a European Organization for research and treatment of cancer soft tissue and bone sarcoma group global network study (EORTC 62072). Cancer, 121(17), 2933–2941.CrossRefPubMed
15.
Quidde, J., Hegewisch Becker, S., Graven, U., Lerchenmueller, C., Killing, B., Depenbusch, R., et al. (2016). Quality of life in patients with metastatic colorectal cancer receiving maintenance therapy after first-line inductive treatment: A quality of life sub-analysis of the AIO KRK 0207 phase III trial. Annals of Oncology. https://​doi.​org/​10.​1093/​annonc/​mdw370.​105.PubMedCrossRef
16.
17.
Wildiers, H., Heeren, P., Puts, M., Topinkova, E., Janssen-Heijnen, M., Extermann, M., et al. (2014). International society of geriatric oncology consensus on geriatric assessment in older patients with cancer. Journal of Clinical Oncology, 32(24), 2595–2603.CrossRefPubMedPubMedCentral
18.
Quinten, C., Kenis, C., Hamaker, M., Coolbrandt, A., Brouwers, B., Dal Lago, L., et al. (2018). The effect of adjuvant chemotherapy on symptom burden and quality of life over time; a preliminary prospective observational study using individual data of patients aged ≥ 70 with early stage invasive breast cancer. Journal of Geriatric Oncology, 9(2), 152–162.CrossRefPubMed
19.
Wedding, U., Röhrig, B., Klippstein, A., Brix, C., Pientka, L., & Höffken, K. (2007). Co-morbidity and functional deficits independently contribute to quality of life before chemotherapy in elderly cancer patients. Support Care Cancer, 15, 1097–1104.CrossRefPubMed
20.
Ediebah, D., Quinten, C., Coens, C., Ringash, J., Dancey, J., Zikos, E., et al. (2018). Quality of life as prognostic indicator of survival: A pooled analysis of individual patient data from Canadian Cancer Trials Group clinical trials. Cancer, 124(16), 3409–3416.CrossRefPubMed
21.
Folstein, M. F., Foldestein, S. E., & McHugh, P. R. (1975). “Mini-mental state”. A practical method for grading the cognitive state of patients for the clinician. Journal of Psychiatric Research, 12(3), 189–198.CrossRefPubMed
22.
Katz, S. (1983). Assessing self-maintenance: Activities of daily living, mobility, and instrumental activities of daily living. Journal of the American Geriatrics Society, 31(12), 721–727.CrossRefPubMed
23.
Lawton, M. P., & Brody, E. M. (1969). Assessment of older people: Self-maintaining and instrumental activities of daily living. Gerontologist, 9(3), 179–186.CrossRefPubMed
24.
Vellas, B., Guigoz, Y., Garry, P. J., Nourhashemi, F., Bennahum, D., Lauque, S., et al. (1999). The mini nutritional assessment (MNA-SF) and its use in grading the nutritional state of elderly patients. Nutrition, 15(2), 116–122.CrossRefPubMed
25.
Sheikh, J. I., & Yesavage, J. A. (1986). Geriatric Depression Scale (GDS): Recent evidence and development of a shorter version. Clinical Gerontologist, 5(1/2), 165–173.
26.
Jensen, M. P., Chen, C., & Brugger, A. M. (2003). Interpretation of visual analogue scale rating and change scores: A reanalysis of two clinical trials of postoperative pain. The Journal of Pain, 4(7), 407–411.CrossRefPubMed
27.
28.
Samsa, S., Edelman, D., Rothman, M. L., Williams, G. R., Lipscomb, J., & Matchar, D. (1999). Determining clinically important differences in health status measures: A general approach with illustration to the Health Utilities Index Mark II. Pharmacoeconomics, 15(2), 141–155.CrossRefPubMed
29.
Eton, D., Cella, D., Yost, K. J., Yount, S. E., Peterman, A. H., Neuberg, D. S., et al. (2004). A combination of distribution- and anchor-based approaches determined minimally important differences (MIDs) for four endpoint in a breast cancer scale. Journal of Clinical Epidemiology, 57(9), 898–910.CrossRefPubMed
30.
Norman, G. R., Sloan, J. A., & Wyrwich, K. W. (2003). Interpretation of changes in health-related quality of life: The remarkable universality of half a standard deviation. Medical Care, 41(5), 582–592.PubMed
31.
Hjermstad, M. J., Fossa, S. D., Bjordal, K., & Kaasa, S. (1995). Test/retest study of the European Organization for research and treatment of cancer core quality of life questionnaire. Journal of Clinical Oncology, 13(5), 1249–1254.CrossRefPubMed
32.
Cella, D., Eton, D. T., Lai, J., Peterman, A. H., & Merkel, D. E. (2002). Combining anchor and distribution-based methods to derive minimal clinically important differences on the Function Assessement of Cancer Therapy (FACT) Anemia and Fatigue Scales. Journal of Pain and Symptom Management, 24(6), 547–561.CrossRefPubMed
33.
Szumilas, M. (2010). Explaining odds ratios. Journal of the Canadian Academy of Child and Adolescent Psychiatry, 19(3), 227–229.PubMedPubMedCentral
34.
Tashjian, R. Z., Deloach, J., Porucznik, C. A., & Powell, A. P. (2009). Minimal clinically important differences (MCID) and patient acceptable symptomatic state (PASS) for visual analog scale (VAS) measuring pain in patients treated for rotator cuff disease. Journal of Shoulder and Elbow Surgery, 18(6), 927–932.CrossRefPubMed
35.
Vinkers, D. J., Gussekloo, J., Stek, M. L., Westendorp, R. G., & Van Der Mast, R. C. (2004). The 15-item Geriatric Depression Scale (GDS-15) detects changes in depressive symptoms after a major negative life event. The Leiden 85-plus study. International Journal of Geriatric Psychiatry, 19(1), 80–84.CrossRefPubMed
36.
Cocks, K., King, M. T., Velikova, G., de Castro Jr. G., Martyn St-James, M., Fayers, P. M., Brown, J. M. (2012). Evidence-based guidelines for interpreting change scores for the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30. European Journal of Cancer, 48(11), 1713–1721.CrossRefPubMed
37.
38.
Ringash, J., O’Sullivan, B., & Bezjak, A. (2007). Interpreting clinically significant changes in patient-reported outcomes. Cancer, 110(1), 196–202.CrossRefPubMed
39.
Cohen, J. (1998). Statistical power analysis for the behavioural sciences. New York: Academic New York.
40.
Howard, G. S., Ralph, K. M., Gulanick, N. A., Maxwell, S. E., Nance, D. W., & Gerber, S. K. (1979). Internal invalidity in pretest-posttest self-report evaluations and a re-evaluation of retrospective pretests. Applied Psychological Measurement, 3(1), 1–23.CrossRef
41.
Oort, F. H., Visser, M. R. M., & Spranger, M. A. G. (2005). An application of structural equation modelling to detect response shifts and true change in quality of life data from cancer patients undergoing invasive surgery. Quality of Life Research, 14(3), 599–609.CrossRefPubMed
42.
43.
Verdam, M. G. E., Oort, F. J., & Sprangers, M. A. G. (2017). Structural equation modelling – based effect-size indices were used to evaluate and interpret the impact of response shift effects. Journal of Clinical Epidemiology, 85, 37–44.CrossRefPubMed
44.
Ousmen, A., Conroy, T., Guillemin, F., Velten, M., Jolly, D., Mercier, M., et al. (2016). Impact of the occurrence of a response shift on the determination of the minimal important difference in a health-related quality of life score over time. Health and Quality of Life Outcomes, 15, 167. https://​doi.​org/​10.​1186/​s12955-016-0569-5.CrossRef
45.
46.
Metagegevens
Titel
Determining clinically important differences in health-related quality of life in older patients with cancer undergoing chemotherapy or surgery
Auteurs
C. Quinten
C. Kenis
L. Decoster
P. R. Debruyne
I. De Groof
C. Focan
F. Cornelis
V. Verschaeve
C. Bachmann
D. Bron
S. Luce
G. Debugne
H. Van den Bulck
J. C. Goeminne
A. Baitar
K. Geboers
B. Petit
C. Langenaeken
R. Van Rijswijk
P. Specenier
G. Jerusalem
J. P. Praet
K. Vandenborre
M. Lycke
J. Flamaing
K. Milisen
J. P. Lobelle
H. Wildiers
Publicatiedatum
03-12-2018
Uitgeverij
Springer International Publishing
Gepubliceerd in
Quality of Life Research / Uitgave 3/2019
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-018-2062-6

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