Sự khác biệt tối thiểu quan trọng trong các thử nghiệm lâm sàng ung thư tuyến tiền liệt đối với bảng hỏi chất lượng cuộc sống EORTC QLQ-C30

BMC Cancer - Tập 21 Số 1 - 2021
Eva‐Maria Gamper1, Jammbe Z. Musoro2, Corneel Coens2, Jean‐Jacques Stelmes3, Claudette Falato2, Mogens Grøenvold4, Galina Velikova5, Kim Cocks6, Hans‐Henning Flechtner7, Madeleine King8, Andrew Bottomley2
1Innsbruck Institute of Patient-centered Outcome Research (IIPCOR), Innsbruck, Austria. [email protected].
2European Organisation for Research and Treatment of Cancer (EORTC)Brussels Belgium
3Department of Radiation Oncology, University Hospital Zurich, Zurich, Switzerland
4Department of Public Health, University of Copenhagen and Bispebjerg Hospital, Copenhagen, Denmark.
5Leeds Institute of Cancer and Pathology, University of Leeds, St James’s Hospital, Leeds, UK
6Adelphi Value, Bollington, Cheshire, UK.
7Clinic for Child and Adolescent Psychiatry and Psychotherapy, University of Magdeburg, Magdeburg, Germany
8University of Sydney, Faculty of Science, School of Psychology, Sydney, NSW, Australia.

Tóm tắt

Tóm tắt Đặt vấn đề

Mục tiêu của nghiên cứu là ước lượng sự khác biệt tối thiểu quan trọng (MID) để diễn giải sự thay đổi ở cấp độ nhóm theo thời gian, cả trong một nhóm và giữa các nhóm, cho các điểm số bảng hỏi chất lượng cuộc sống EORTC QLQ-C30 ở bệnh nhân ung thư tuyến tiền liệt.

 Phương pháp

Chúng tôi sử dụng dữ liệu từ hai thử nghiệm EORTC đã công bố. Các điểm neo lâm sàng được chọn dựa trên mức độ tương quan với các thang đo QLQ-C30. Ngoài ra, ý kiến của các bác sĩ lâm sàng được thu thập để đánh giá tính hợp lý của các điểm neo được chọn. Phương pháp thay đổi trung bình được áp dụng để diễn giải sự thay đổi theo thời gian trong một nhóm bệnh nhân và các mô hình hồi quy tuyến tính được điều chỉnh để ước lượng MID cho sự khác biệt giữa các nhóm về sự thay đổi theo thời gian. Các ước lượng dựa trên phân phối cũng được đánh giá.

Từ khóa

#sự khác biệt tối thiểu quan trọng #ung thư tuyến tiền liệt #bảng hỏi chất lượng cuộc sống #EORTC QLQ-C30

Tài liệu tham khảo

Yost KJ, et al. Minimally important differences were estimated for the functional assessment of cancer therapy-colorectal (FACT-C) instrument using a combination of distribution- and anchor-based approaches. J Clin Epidemiol. 2005;58(12):1241–51.

Lydick E, Epstein RS. Interpretation of quality of life changes. Qual Life Res. 1993;2(3):221–6.

Guyatt GH, et al. Methods to explain the clinical significance of health status measures. Mayo Clin Proc. 2002;77(4):371–83.

Schünemann HJ, Guyatt GH. Commentary–goodbye M(C)ID! Hello MID, Where do you come from? Health Serv Res. 2005;40(2):593–7.

Schunemann HJ, Akl EA, Guyatt GH. Interpreting the results of patient reported outcome measures in clinical trials: the clinician's perspective. Health Qual Life Outcomes. 2006;4(1):62. https://doi.org/10.1186/1477-7525-4-62.

Revicki D, et al. Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol. 2008;61(2):102–9.

King MT. A point of minimal important difference (MID): a critique of terminology and methods. Expert Rev Pharmacoecon Outcomes Res. 2011;11(2):171–84.

Giesinger JM, Efficace F, Aaronson N, Calvert M, Kyte D, Cottone F, Cella D, Gamper EM. Past and current practice of patient-reported outcome measurement in randomized cancer clinical trials: a systematic review. Value Health. 2021 Apr;24(4):585–91.

Osoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol. 1998;16(1):139–44. https://doi.org/10.1200/JCO.1998.16.1.139.

Cocks K, 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 Jul;48(11):1713-21.

King MT. The interpretation of scores from the EORTC quality of life questionnaire QLQ-C30. Qual Life Res. 1996;5(6):555–67. https://doi.org/10.1007/BF00439229.

Musoro ZJ, et al. Establishing anchor-based minimally important differences (MID) with the EORTC quality-of-life measures: a meta-analysis protocol. BMJ Open. 2018 Jan 10;8(1):e019117.

Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7–30.

Eton DT, Lepore SJ. Prostate cancer and health-related quality of life: a review of the literature. Psycho-Oncology. 2002;11(4):307–26. https://doi.org/10.1002/pon.572.

Luz MA, et al. Consensus on prostate Cancer treatment of localized disease with very low, low, and intermediate risk: a report from the first prostate Cancer consensus conference for developing countries (PCCCDC). JCO Glob Oncol. 2021 Apr;7:523–9.

Pratsinis M, Halabi S, Güsewell S, Gillessen S, Omlin A. In-depth analysis of the 2019 advanced prostate Cancer consensus conference: the importance of representation of medical specialty and geographic regions. Eur Urol Open Sci. 2021;26:14–7. https://doi.org/10.1016/j.euros.2021.01.010.

Bolla M, et al. Duration of androgen suppression in the treatment of prostate cancer. N Engl J Med. 2009;360(24):2516–27.

Bolla M, et al. Short Androgen Suppression and Radiation Dose Escalation for Intermediate- and High-Risk Localized Prostate Cancer: Results of EORTC Trial 22991. J Clin Oncol. 2016;34(15):1748–56.

Fayers P, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A. E ORTC QLQ-C30 Scoring Manual. 3rd ed. European Organisation for Research and Treatment of Cancer; 2001.

Musoro JZ, et al. Interpreting European Organisation for Research and Treatment for Cancer Quality of life Questionnaire core 30 scores as minimally importantly different for patients with malignant melanoma. Eur J Cancer. 2018;104:169–81.

Musoro JZ, et al. Minimally important differences for interpreting EORTC QLQ-C30 scores in patients with advanced breast cancer. JNCI Cancer Spectr. 2019;3(3):pkz037.

Musoro JZ, Coens C, Singer S, Tribius S, Oosting SF, Groenvold M, et al. Minimally important differences for interpreting European Organisation for Research and Treatment of Cancer quality of life questionnaire Core 30 scores in patients with head and neck cancer. Head & neck. 2020;42(11):3141–52. https://doi.org/10.1002/hed.26363.

Musoro JZ, Sodergren SC, Coens C, Pochesci A, Terada M, King MT, et al. Minimally important differences for interpreting the EORTC QLQ-C30 in patients with advanced colorectal cancer treated with chemotherapy. Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland. 2020;22(12):2278–87. https://doi.org/10.1111/codi.15295.

Liang KY, Zeger SL. Regression analysis for correlated data. Annu Rev Public Health. 1993;14(1):43–68. https://doi.org/10.1146/annurev.pu.14.050193.000355.

Cohen J. Statistical Power Analysis for the Behavioural Sciences. 2nd ed. Hillsdale: Lawrence Erlbaum Associates; 1988.

Cocks K, 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):1713–21.

Cocks K, 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(1):89–96.

Maringwa J, et al. Minimal clinically meaningful differences for the EORTC QLQ-C30 and EORTC QLQ-BN20 scales in brain cancer patients. Ann Oncol. 2011;22(9):2107–12.

Ringash J, et al. Interpreting clinically significant changes in patient-reported outcomes. Cancer. 2007;110(1):196–202.

Cella D, et al. Clinical consensus meeting group. Group vs individual approaches to understanding the clinical significance of differences or changes in quality of life. Mayo Clin Proc. 2002;77:384–92.

Maringwa JT, et al. Minimal important differences for interpreting health-related quality of life scores from the EORTC QLQ-C30 in lung cancer patients participating in randomized controlled trials. Support Care Cancer. 2011;19(11):1753–60.

Fairchild AT, et al. Interrater reliability in toxicity identification: limitations of current standards. Int J Rad Oncol Biol Phys. 2020;107(5):996–1000.

Thông tin
Thông tin xuất bản

BMC Cancer

Tập 21 Số 1

Thông tin tác giả