Schwartz J S
Leonard Davis Institute of Health Economics, Philadelphia, PA 19104-6218, USA.
J Natl Cancer Inst Monogr. 1995(19):73-5.
The Prostate Cancer Intervention Versus Observation Trial (PIVOT) compares radical prostatectomy with palliative expectant management of patients with clinically localized prostate disease. As with all clinical trials, several of the assumptions underlying PIVOT are characterized by uncertainty. Economic analysis has the potential to clarify some of these important issues, thereby guiding study design and interpretation and enhancing the clinical usefulness of the findings. One important uncertainty about the trial relates to the true clinical state of potentially eligible patients. While clinical examination is an insensitive method by which to stage prostate cancer, several diagnostic tests, such as bone scanning and magnetic resonance imaging with rectal coil, are more accurate but more expensive. Another issue is whether to start the trial with the screening of patients or at the time of prostate cancer diagnosis. Economic analysis can assess these trade-offs between study cost and validity. A second potential role for health economics is in dealing with the considerable uncertainty surrounding the study's findings and conclusions and their interpretation. While the stated primary outcome of the trial is survival, a multidimensional outcome (particularly one that incorporates factors of survival, quality of life, and cost) is likely to be more clinically relevant in the prostate cancer population, given the only modest improvements in survival hypothesized for radical prostatectomy. To develop such a measure, quantitative assessment of patient preferences is required, in addition to the measures currently included in the study. Assessment of costs of care are important, given the large and growing size of the study's target population.(ABSTRACT TRUNCATED AT 250 WORDS)
前列腺癌干预与观察试验（PIVOT）将根治性前列腺切除术与临床局限性前列腺疾病患者的姑息性期待治疗进行比较。与所有临床试验一样，PIVOT所基于的一些假设存在不确定性。经济分析有可能澄清其中一些重要问题，从而指导研究设计和解读，并提高研究结果的临床实用性。该试验的一个重要不确定性涉及潜在合格患者的真实临床状态。虽然临床检查在前列腺癌分期方面并不敏感，但一些诊断测试，如骨扫描和直肠线圈磁共振成像，更准确但更昂贵。另一个问题是该试验应以筛查患者开始还是在前列腺癌诊断时开始。经济分析可以评估研究成本与有效性之间的这些权衡。卫生经济学的第二个潜在作用是处理围绕该研究的结果、结论及其解读的相当大的不确定性。虽然该试验规定的主要结果是生存，但考虑到根治性前列腺切除术对生存的改善较为有限，多维结果（特别是包含生存、生活质量和成本因素的结果）在前列腺癌人群中可能在临床上更具相关性。要制定这样一种衡量标准，除了目前研究中包含的指标外，还需要对患者偏好进行定量评估。鉴于该研究目标人群规模庞大且不断增长，护理成本评估很重要。
