542 692
[8]
Harland S, Staffurth J, Molina A, et al. Effect of abiraterone acetate treatment on the quality of life of patients with metastatic castra- tion-resistant prostate cancer after failure of docetaxel chemother- apy. Eur J Cancer 2013;49:3648–57.[9]
Scher HI, Fizazi K, Saad F, et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med 2012;367: 1187–97.[10]
Shore ND, Chowdhury S, Villers A, et al. Efficacy and safety of enzalutamide versus bicalutamide for patients with metastatic prostate cancer (TERRAIN): A randomised, double-blind, phase 2 study. Lancet Oncol 2016;17:153–63.[11]
Farrar JT, Portenoy RK, Berlin JA, Kinman JL, Strom BL. Defining the clinically important difference in pain outcome measures. Pain 2000;88:287–94.
[12]
Little RJA, Rubin DB. Statistical analysis with missing data. ed 2. Hoboken, NJ: John Wiley & Sons, Inc; 2002.
[13]
O’Kelly M, Ratitch B. Clinical trials with missing data: A guide for practitioners. Chichester, UK: John Wiley & Sons; 2014.
[14]
Cook CE. Clinimetrics corner: The Minimal Clinically Important Change Score (MCID): A necessary pretense. J Man Manip Ther 2008;16:E82–3.
[15]
Basch E, Loblaw DA, Oliver TK, et al. Systemic therapy in men with metastatic castration-resistant prostate cancer: American Society of Clinical Oncology and Cancer Care Ontario clinical practice guideline. J Clin Oncol 2014;32:3436–48.
[16]
Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singapore 1994;23:129–38.
[17]
Scher HI, Morris MJ, Stadler WM, et al. Trial design and objectives for castration-resistant prostate cancer: updated recommenda- tions from the Prostate Cancer Clinical Trials Working Group 3. J Clin Oncol 2016;34:1402–18.
[18]
Halabi S, Vogelzang NJ, Kornblith AB, et al. Pain predicts overall survival in men with metastatic castration-refractory prostate cancer. J Clin Oncol 2008;26:2544–9.
[19]
Watts S, Leydon G, Birch B, et al. Depression and anxiety in prostate cancer: a systematic review and meta-analysis of prevalence rates. BMJ Open 2014;4:e003901.[20]
Yang YL, Sui GY, Liu GC, Huang DS, Wang SM, Wang L. The effects of psychological interventions on depression and anxiety among Chinese adults with cancer: a meta-analysis of randomized con- trolled studies. BMC Cancer 2014;14:956.[21]
Dale W, Bilir P, Han M, Meltzer D. The role of anxiety in prostate carcinoma: a structured review of the literature. Cancer 2005;104:467–78.[22] Penson DF, Armstrong AJ, Concepcion R, et al. Enzalutamide versus
bicalutamide in castration-resistant prostate cancer: The STRIVE
Trial. J Clin Oncol 2016;34:2098–106
. http://dx.doi.org/10.1200/ JCO.2015.64.9285.
[23]
Yost KJ, Eton DT. Combining distribution- and anchor-based approaches to determine minimally important differences: the FACIT experience. Eval Health Prof 2005;28:172–91.[24]
Esper P, Mo F, Chodak G, Sinner M, Cella D, Pienta KJ. Measuring quality of life in men with prostate cancer using the Functional Assessment of Cancer Therapy-prostate instrument. Urology 1997;50:920–8.
[25]
Cella D, Nichol MB, Eton D, Nelson JB, Mulani P. Estimating clinically meaningful changes for the Functional Assessment of Cancer Ther- apy-Prostate: Results from a clinical trial of patients with metastatic hormone-refractory prostate cancer. Value Health 2009;12:124–9.
[26]
Yount S, Cella D, Banik D, Ashraf T, Shevrin D. Brief assessment of priority symptoms in hormone refractory prostate cancer: The FACT Advanced Prostate Symptom Index (FAPSI). Health Qual Life Outcomes 2003;1:69.
[27]
Pickard AS, Neary MP, Cella D. Estimation of minimally important differences in EQ-5D utility and VAS scores in cancer. Health Qual Life Outcomes 2007;5:70.[28] EuroQol 2015. EQ-5D-3L User Guide. Available at:
http://www. euroqol.org/fileadmin/user_upload/Documenten/PDF/Folders_ Flyers/EQ-5D-3L_UserGuide_2015.pdf. Accessed December 4, 2015.
[29]
Dolan P. Modeling valuations for EuroQol health states. Med Care 1997;35:1095–108.[30]
Dworkin RH, Turk DC, Wyrwich KW, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain 2008;9:105–21.
E U R O P E A N U R O L O G Y 7 1 ( 2 0 1 7 ) 5 3 4 – 5 4 2
542