Platt R, Davis R, Finkelstein J, Go A S, Gurwitz J H, Roblin D, Soumerai S, Ross-Degnan D, Andrade S, Goodman M J, Martinson B, Raebel M A, Smith D, Ulcickas-Yood M, Chan K A
Harvard Medical School, Boston, MA, USA.
Pharmacoepidemiol Drug Saf. 2001 Aug-Sep;10(5):373-7. doi: 10.1002/pds.607.
Research and education programs in therapeutics that combine the data, organizational capabilities, and expertise of several managed care organizations working in concert can serve an important role when a single organization is not large enough to address a question of interest, when diversity in populations or delivery systems is required, and when it is necessary to establish consistency of results in different settings. Nine members of the HMO Research Network, a consortium of health maintenance organizations (HMOs) that perform public domain research, have formed a Center for Education and Research on Therapeutics (CERT), sponsored by the Agency for Healthcare Research and Quality, to conduct multicenter research in therapeutics. The CERT uses a distributed organizational model with shared leadership, in which data reside at the originating organization until they are needed to support a specific study. Extraction of data from the host computer systems, and some manipulation of data, is typically accomplished through computer programs that are developed centrally, then modified for use at each site. For complex studies, pooled analysis files are created by a coordinating center, and then analysed by investigators throughout the HMOs. It is also possible to contact HMO members when necessary. This multicenter environment has several benefits, addressing: (1) a wide array of questions about the safety and effectiveness of therapeutics, (2) the impact of efforts to change clinicians' and patients' behavior, and (3) pharmacoeconomic and pharmacogenetic questions.
治疗学方面的研究和教育项目,若能将多个协同工作的管理式医疗组织的数据、组织能力及专业知识结合起来,当单个组织规模不足以解决感兴趣的问题时,当需要人群或医疗服务系统的多样性时,以及当有必要在不同环境中确立结果的一致性时,便可发挥重要作用。健康维护组织研究网络(HMO研究网络)由九个进行公共领域研究的健康维护组织(HMO)组成,它们在医疗保健研究与质量局的资助下,成立了治疗学教育与研究中心(CERT),以开展治疗学方面的多中心研究。CERT采用一种具有共享领导权的分布式组织模式,数据存于原始组织,直至为支持某项特定研究而需要时才使用。从主机系统提取数据以及对数据进行一些处理,通常是通过集中开发、然后针对每个站点进行修改的计算机程序来完成的。对于复杂的研究,由一个协调中心创建汇总分析文件,然后由各HMO的研究人员进行分析。必要时还可以联系HMO成员。这种多中心环境有诸多益处,包括:(1)解决有关治疗学安全性和有效性的一系列广泛问题;(2)改变临床医生和患者行为所做努力的影响;(3)药物经济学和药物遗传学问题。