Swipe om te navigeren naar een ander artikel
The online version of this article (https://doi.org/10.1007/s11136-018-2062-6) contains supplementary material, which is available to authorized users.
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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.
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.
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.
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.
Log in om toegang te krijgen
Met onderstaand(e) abonnement(en) heeft u direct toegang:
Supplementary material 1 (DOCX 17 KB)11136_2018_2062_MOESM1_ESM.docx
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
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
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
American Cancer Society. Treatments and side effects. Retrieved October 4, 2018, from http://www.cancer.org/treatment/treatmentsandsideeffects/index.
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
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
NIH. U.S.National Library of Medicine. Retrieved October, 4, 2018, from https://clinicaltrials.gov/ct2/show/NCT02395172.
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
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.
Drasgow, F. (2006). Polychoric and polyserical correlations. Encyclopedia of Statistical Sciences. https://doi.org/10.1002/0471667196.ess2014.pub2. CrossRef
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
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
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
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
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
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
Cohen, J. (1998). Statistical power analysis for the behavioural sciences. New York: Academic New York.
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
Anota, A., Bascoul-Mollevi, C., Conroy, T., Guillemin, F., Velten, M., Jolly, D., et al. (2014) Item response theory and factor analysis as a mean to characterize occurrence of response shift in a longitudinal quality of life study in breast cancer patients. Health and Quality of Life Outcomes, 12, 32. https://doi.org/10.1186/1477-7525-12-32. CrossRefPubMedPubMedCentral
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
Scott, N. W., Fayers, P. M., Aaronson, N. K., Bottomley, A., de Graeff, A., Groenveld, M., et al. (2010) Differential item functioning (DIF) analyses of health-related quality of life instrument using logistic regression. Health and Quality of Life Outcomes, 8, 81. https://doi.org/10.1186/1477-7525-8-81. PubMedPubMedCentralCrossRef
Musoro, Z. J., Hamel, J. F., Ediebah, D. E., Cocks, K., King, M. T., Groenveld, M., et al. (2018). Establishing anchor-based minimally import differences (MID) with the EORTC quality-of-life measures: A meta-analysis protocol. British Medical Journal Open, 8, e019117. https://doi.org/10.1136/bmjopen-2017-019117. CrossRef
- Determining clinically important differences in health-related quality of life in older patients with cancer undergoing chemotherapy or surgery
P. R. Debruyne
I. De Groof
H. Van den Bulck
J. C. Goeminne
R. Van Rijswijk
J. P. Praet
J. P. Lobelle
- Springer International Publishing