Patient self-appraisal of change and minimal clinically important difference on the European organization for the research and treatment of cancer quality of life questionnaire core 30 before and during cancer therapy

BMC Cancer

Donna L Berry²  Nigel Bush¹  Jaclyn L F Bosco²  Fanxing Hong³ 

[1]National Center for Telehealth and Technology, Joint Base Lewis-McChord, Tacoma, WA, USA

[2]Phyllis F. Cantor Center, Dana-Farber Cancer Institute, Department of Medicine, Harvard Medical School, Boston, MA, USA

[3]Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Harvard School of Public Health, Boston, MA, USA

关键词: Minimal clinically important differences;    Subject significance questionnaire;    Quality of life questionnaire-core;    Health related quality of life;    Cancer treatment;   

Others  :  1079825
DOI  :  10.1186/1471-2407-13-165

 received in 2012-08-13, accepted in 2013-03-13,  发布年份 2013

【 摘 要 】

Background

Clinical interpretation of health related quality of life (HRQOL) scores is challenging. The purpose of this analysis was to interpret score changes and identify minimal clinically important differences (MCID) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) before (T1) and during (T2) cancer treatment.

Methods

Patients (N = 627) in stem cell transplant (SCT) and medical (MED) or radiation (RAD) oncology at two comprehensive cancer centers, enrolled in the Electronic Self-Report Assessment-Cancer study and completed the QLQ-C30 at T1 and T2. Perceived changes in five QOL domains, physical (PF), emotional (EF), social (SF), cognitive functioning (CF) and global quality of life (QOL), were reported using the Subject Significance Questionnaire (SSQ) at T2. Anchored on SSQ ratings indicating “improvement”, “the same”, or “deterioration”, means and effect sizes were calculated for QLQ-C30 score changes. MCID was calculated as the mean difference in QLQ-C30 score changes reflecting one category change on SSQ rating, using a two-piece linear regression model.

Results

A majority of SCT patients (54%) perceived deteriorating global HRQOL versus improvement (17%), while approximately equal proportions of MED/RAD patients perceived improvement (25%) and deterioration (26%). Global QOL decreased 14.2 (SCT) and 2.0 (MED/RAD) units, respectively, among patients reporting “the same” in the SSQ. The MCID ranged 5.7-11.4 (SCT) and 7.2-11.8 (MED/RAD) units among patients reporting deteriorated HRQOL; ranged 2.7-3.4 units among MED/RAD patients reporting improvement. Excepting for the global QOL (MCID =6.9), no meaningful MCID was identified among SCT patients reporting improvement.

Conclusions

Cancer treatment has greater impact on HRQOL among SCT patients than MED/RAD patients. The MCID for QLQ-C30 score change differed across domains, and differed for perceived improvement and deterioration, suggesting different standards for self-evaluating changes in HRQOL during cancer treatment. Specifically, clinical attention can be focused on patients who report at least a 6 point decrease, and for patients who report at least a 3 point increase on QLQ-C30 domains.

Trial registration

The trial was registered with ClinicalTrials.gov: NCT00852852

【 授权许可】

   
2013 Hong et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

【 参考文献 】

• [1]Osthus AA, Aarstad AK, Olofsson J, et al.: Health-related quality of life scores in long-term head and neck cancer survivors predict subsequent survival: a prospective cohort study. Clin Otolaryngol 2011, 36:361-8.
• [2]Svensson H, Hatschek T, Johansson H, et al.: Health-related quality of life as prognostic factor for response, progression-free survival, and survival in women with metastatic breast cancer. Med Oncol; 2011.
• [3]Wan Leung S, Lee TF, Chien CY, et al.: Health-related quality of life in 640 head and neck cancer survivors after radiotherapy using EORTC QLQ-C30 and QLQ-H&N35 questionnaires. BMC Cancer 2011, 11:128. BioMed Central Full Text
• [4]Aaronson NK, Ahmedzai S, Bergman B, et al.: The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993, 85:365-76.
• [5]Osoba D, Rodrigues G, Myles J, et al.: Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol 1998, 16:139-44.
• [6]King MT: The interpretation of scores from the EORTC quality of life questionnaire QLQ-C30. Qual Life Res 1996, 5:555-67.
• [7]Grulke N, Albani C, Bailer H: Quality of life in patients before and after haematopoietic stem cell transplantation measured with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire QLQ-C30. Bone Marrow Transplant 2012, 47:473-82.
• [8]Cocks K, King MT, Velikova G, et al.: Evidence-based guidelines for determination of sample size and interpretation of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30. J Clin Oncol 2011, 29:89-96.
• [9]Ringash J, O’Sullivan B, Bezjak A, et al.: Interpreting clinically significant changes in patient-reported outcomes. Cancer 2007, 110:196-202.
• [10]Cella D, Hahn EA, Dineen K: Meaningful change in cancer-specific quality of life scores: differences between improvement and worsening. Qual Life Res 2002, 11:207-21.
• [11]Maringwa J, Quinten C, King M, et al.: Minimal clinically meaningful differences for the EORTC QLQ-C30 and EORTC QLQ-BN20 scales in brain cancer patients. Ann Oncol 2011, 22:2107-12.
• [12]Kvam AK, Fayers PM, Wisloff F: Responsiveness and minimal important score differences in quality-of-life questionnaires: a comparison of the EORTC QLQ-C30 cancer-specific questionnaire to the generic utility questionnaires EQ-5D and 15D in patients with multiple myeloma. Eur J Haematol 2011, 87:330-7.
• [13]Cocks K, King MT, Velikova G, et al.: Evidence-based guidelines for interpreting change scores for the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Eur J Cancer 2012, 48(11):1713-1721.
• [14]Jaeschke R, Singer J, Guyatt GH: Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials 1989, 10:407-15.
• [15]Osoba D: Interpreting the meaningfulness of changes in health-related quality of life scores: lessons from studies in adults. Int J Cancer Suppl 1999, 12:132-7.
• [16]Berry DL, Blumenstein BA, Halpenny B, et al.: Enhancing patient-provider communication with the electronic self-report assessment for cancer: a randomized trial. J Clin Oncol 2011, 29:1029-35.
• [17]Fayers P, Aaronson N, Bjordal K, et al.: EORTC QLQ-C30 Scoring Manual (ed 3rd). EORTC: Brussels; 2001.
• [18]Rodrigues G, Bezjak A, Osoba D, et al.: The relationship of changes in EORTC QLQ-C30 scores to ratings on the Subjective Significance Questionnaire in men with localized prostate cancer. Qual Life Res 2004, 13:1235-46.
• [19]Cohen J: Statistical power analysis for the behavioral sciences. Hillsdale: Erlbaum; 1988.
• [20]Frodin U, Borjeson S, Lyth J, et al.: A prospective evaluation of patients’ health-related quality of life during auto-SCT: a 3-year follow-up. Bone Marrow Transplant 2011, 46:1345-52.
• [21]Schwartz CE, Sprangers MA: Methodological approaches for assessing response shift in longitudinal health-related quality-of-life research. Soc Sci Med 1999, 48:1531-48.
• [22]Tierney DK, Facione N, Padilla G, et al.: Response shift: a theoretical exploration of quality of life following hematopoietic cell transplantation. Cancer Nurs 2007, 30:125-38.
• [23]Kamper SJ, Maher CG, Mackay G: Global rating of change scales: a review of strengths and weaknesses and considerations for design. The Journal of manual & manipulative therapy 2009, 17(3):163-170.