Reported Outcomes Why Methods in Clinical Cancer 的病人报告结果为什么在临床癌症的方法课件.pptVIP

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Reported Outcomes Why Methods in Clinical Cancer 的病人报告结果为什么在临床癌症的方法课件.ppt

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Reported Outcomes Why Methods in Clinical Cancer 的病人报告结果为什么在临床癌症的方法课件

* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * Question In the mitoxantrone/Prednisone trial just discussed, how would do you account for missing data? Question a. Anticipate attrition, identify a proxy at the point at which the patient is unavailable b. the sample size should be large enough to dilute the effect of missing data c. anticipate loss of patient availability and identify proxies at the start of the study d. use of a proxy will never provide validated data in a study in which HRQoL is an important endpoint R A N D O M I Z E Bilateral Orchiectomy* + Flutamide *Within one week of registration. Bilateral Orchiectomy* + Placebo JNCI 1998; 90: 1537-44 SWOG 8894: Hormonal Therapy of Advanced Metastatic Prostate Cancer SWOG 9039: QOL Companion to S8894Activation History Therapeutic trial, S8894, opened 12/89 QOL Companion study, S9039, opened 10/90 ~ 290/1387 patients registered to therapeutic trial QOL sample size: 500 patients Both studies closed to accrual 9/94 S9039: Primary Quality of Life Endpoints Treatment-specific symptoms Diarrhea Gas Pain Body Image Emotional Functioning Physical Functioning HRQOL Results Placebo arm significantly better Emotional status Less diarrhea Consistent picture Placebo arm patients reported better HRQOL Flutamide not palliative Appears to worsen HRQOL relative to placebo Could have missed an important outcome if just measured symptoms Median Emotional Well-Being Scores Minor Med Cond CHF COPD Hyperten 100 90 80 70 60 0 Orch + Placebo Orch + Flutamide /// S9039 Patients at 6 Months General Population: Patientswith Medical Conditions 1. Integration of QOL outcomes in cancer clinical trials is challenging 2. Anticipation of design, data collection, and analysis will decrease some problems 3. Additional resources are required to incorporate QOL outcomes successfully-budget for them! CONCLUSIONS: Despite the Uphill Climb…we’re getting there Acknowle