Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment: A Systematic Review of the Literature.
Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment: A Systematic Review of the Literature.
复制标题
DOI：
10.3389/fphar.2017.00189
复制
发表时间：
2017
影响因子：
5.6
通讯作者：
Salek S
中科院分区：
文献类型：
--
作者：
Bujar M;McAuslane N;Walker SR;Salek S
简介：尽管制药公司、监管机构和卫生技术评估（HTA）机构越来越多地使用决策框架，但尚不确定这些框架是否能提高决策质量。这可以通过正式评价这些组织内部决策过程的质量来解决。这一文献综述的目的是确定当前的技术（工具，问卷调查，调查和研究）的决策过程中的三个利益相关者的质量进行测量。研究方法：使用MEDLINE、Web of Knowledge和其他基于互联网的搜索引擎，进行了文献综述，以系统地识别用于评估药物开发、监管审查和HTA中决策质量的技术。使用关键词进行结构化检索，并进行二次审查。此外，每种技术的测量性能进行了评估和比较。10个质量决策实践（QDMPs）以前开发的，然后作为一个框架，在审查中确定的技术进行评估。由于确定的研究存在差异，荟萃分析不合适。结果如下：该综述确定了13种技术，其中7种专门用于评估药物开发、监管审查或卫生技术评估中的决策; 2种检查了公司决策，4种一般决策。关于每种技术与10种QDMP的一致程度，13种技术评估的中位数为6种QDMP，模式为3种QDMP。只有两种技术评估所有10个QDMP，即组织智商和决策质量导向计划（QoDoS），其中只有一种技术，QoDoS可以应用于评估个人和组织的决策，它具有概括性，以捕捉相关的公司以及监管机构的问题。结论：这篇综述证实了这一领域研究的普遍缺乏，特别是关于评估质量决策的技术的开发和系统应用，没有围绕黄金标准达成共识。该综述已将QoDoS确定为评估药物生命周期中决策的最有前途的可用技术，下一步将进一步测试其有效性，灵敏度和可靠性。
Introduction: Although pharmaceutical companies, regulatory authorities, and health technology assessment (HTA) agencies have been increasingly using decision-making frameworks, it is not certain whether these enable better quality decision making. This could be addressed by formally evaluating the quality of decision-making process within those organizations. The aim of this literature review was to identify current techniques (tools, questionnaires, surveys, and studies) for measuring the quality of the decision-making process across the three stakeholders. Methods: Using MEDLINE, Web of Knowledge, and other Internet-based search engines, a literature review was performed to systematically identify techniques for assessing quality of decision making in medicines development, regulatory review, and HTA. A structured search was applied using key words and a secondary review was carried out. In addition, the measurement properties of each technique were assessed and compared. Ten Quality Decision-Making Practices (QDMPs) developed previously were then used as a framework for the evaluation of techniques identified in the review. Due to the variation in studies identified, meta-analysis was inappropriate. Results: This review identified 13 techniques, where 7 were developed specifically to assess decision making in medicines' development, regulatory review, or HTA; 2 examined corporate decision making, and 4 general decision making. Regarding how closely each technique conformed to the 10 QDMPs, the 13 techniques assessed a median of 6 QDMPs, with a mode of 3 QDMPs. Only 2 techniques evaluated all 10 QDMPs, namely the Organizational IQ and the Quality of Decision Making Orientation Scheme (QoDoS), of which only one technique, QoDoS could be applied to assess decision making of both individuals and organizations, and it possessed generalizability to capture issues relevant to companies as well as regulatory authorities. Conclusion: This review confirmed a general paucity of research in this area, particularly regarding the development and systematic application of techniques for evaluating quality decision making, with no consensus around a gold standard. This review has identified QoDoS as the most promising available technique for assessing decision making in the lifecycle of medicines and the next steps would be to further test its validity, sensitivity, and reliability.