The Development and Validation of a Generic Instrument, QoDoS, for Assessing the Quality of Decision Making.
The Development and Validation of a Generic Instrument, QoDoS, for Assessing the Quality of Decision Making.
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DOI：
10.3389/fphar.2016.00180
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发表时间：
2016
影响因子：
5.6
通讯作者：
Salek S
中科院分区：
文献类型：
--
作者：
Donelan R;Walker S;Salek S
简介：药品开发和监管审查过程中决策的影响极大地影响新药品的交付。目前，还没有可以用来评估决策质量的通用工具。本研究描述了用于评估决策质量的决策质量定向计划 QoDoS© 工具的开发。方法：对来自制药行业（10 名）、监管机构（9 名）和合同研究组织（10 名）的 29 名高级决策者进行了半结构化访谈。访谈提供了对参与新药交付的个人和组织的主观决策方法、影响、行为和其他影响此类过程的因素的合格理解。使用 NVivo8® 软件对转录的采访进行主题分析。内容有效性由专家小组使用定性和定量数据进行，从而产生了 QoDoS 的开发版本。进行了进一步的心理测量评估，包括因素分析、项目减少、可靠性测试和结构验证。结果：访谈的主题分析产生了包含 94 项的 QoDoS© 初始版本，采用 5 点李克特量表。专家小组对该工具的内容有效性进行了语言清晰度、完整性、相关性和规模的测试，小组成员一致同意，组内相关系数值为 0.89（95% 置信区间 = 0.56, 0.99）。内容验证产生了包含 76 项的 QoDoS©（版本 2）。因子分析产生了包含四个领域的 47 项测量值。 47 项 QoDoS©（版本 3）显示出高内部一致性（n = 120，Cronbach's alpha = 0.89）、高再现性（n = 20，类内相关性 = 0.77）和平均完成时间为 10 分钟。成功进行了可靠性测试和结构验证。结论：QoDoS© 既可靠又有效。它具有被制药行业和监管机构广泛用于药物开发的潜力。 QoDoS© 可用于评估决策质量并告知决策者影响决策的因素。
Introduction: The impact of decision-making during the development and the regulatory review of medicines greatly influences the delivery of new medicinal products. Currently, there is no generic instrument that can be used to assess the quality of decision-making. This study describes the development of the Quality of Decision-Making Orientation Scheme QoDoS© instrument for appraising the quality of decision-making. Methods: Semi-structured interviews about decision-making were carried out with 29 senior decision makers from the pharmaceutical industry (10), regulatory authorities (9) and contract research organizations (10). The interviews offered a qualified understanding of the subjective decision-making approach, influences, behaviors and other factors that impact such processes for individuals and organizations involved in the delivery of new medicines. Thematic analysis of the transcribed interviews was carried out using NVivo8® software. Content validity was carried out using qualitative and quantitative data by an expert panel, which led to the developmental version of the QoDoS. Further psychometric evaluations were performed, including factor analysis, item reduction, reliability testing and construct validation. Results: The thematic analysis of the interviews yielded a 94-item initial version of the QoDoS© with a 5-point Likert scale. The instrument was tested for content validity using a panel of experts for language clarity, completeness, relevance and scaling, resulting in a favorable agreement by panel members with an intra-class correlation coefficient value of 0.89 (95% confidence interval = 0.56, 0.99). A 76-item QoDoS© (version 2) emerged from content validation. Factor analysis produced a 47-item measure with four domains. The 47-item QoDoS© (version 3) showed high internal consistency (n = 120, Cronbach's alpha = 0.89), high reproducibility (n = 20, intra-class correlation = 0.77) and a mean completion time of 10 min. Reliability testing and construct validation was successfully performed. Conclusion: The QoDoS© is both reliable and valid for use. It has the potential for extensive use in medicines development by both the pharmaceutical industry and regulatory authorities. The QoDoS© can be used to assess the quality of decision-making and to inform decision makers of the factors that influence decision-making.