Toward Minimum Standards for Certifying Patient Decision Aids: A Modified Delphi Consensus Process
Toward Minimum Standards for Certifying Patient Decision Aids: A Modified Delphi Consensus Process
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DOI：
10.1177/0272989x13501721
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发表时间：
2014-08-01
影响因子：
3.6
通讯作者：
Elwyn, Glyn
中科院分区：
文献类型：
--
作者：
Joseph-Williams, Natalie;Newcombe, Robert;Elwyn, Glyn
目标。IPDAS合作开发了一份核对表和一种工具(IPDASi v3.0)，以评估患者决策辅助设备(PDA)的开发过程和共享决策设计组件的质量。美国和其他地方对掌上电脑的认证越来越感兴趣。我们报告了修改后的德尔福共识过程，以商定应被视为PDA认证的最低标准的IPDASi(v3.0)项目，以包括在改进的IPDASi(v4.0)中。方法：研究方法。德尔福两阶段投票程序将IPDASi(v3.0)项目作为最低标准纳入。分析项目分数和定性评论，然后进行专家组讨论。结果。101人在第一轮投票；87人在第二轮投票。47个项目被减少到44个项目，涉及3个新类别：1)资格标准，这是将干预视为决策辅助所必需的(6个项目)；2)认证标准，如果没有这些标准，则被判定为有害偏见的高风险(10个项目)；以及3)质量标准，据信可以加强决策辅助，但其遗漏不会带来有害偏见的高风险(28个项目)。结论。这项研究为PDA提供了初步的认证标准。评分和评级过程需要进行测试和最终确定。然而，评估PDA报告的临床证据质量的过程应该用来补充这些标准；拟议的标准旨在评估开发过程和共享决策设计元素的质量，而不是PDA的临床内容的质量。
Objective. The IPDAS Collaboration has developed a checklist and an instrument (IPDASi v3.0) to assess the quality of patient decision aids (PDAs) in terms of their development process and shared decision-making design components. Certification of PDAs is of growing interest in the US and elsewhere. We report a modified Delphi consensus process to agree on IPDASi (v3.0) items that should be considered as minimum standards for PDA certification, for inclusion in the refined IPDASi (v4.0). Methods. A 2-stage Delphi voting process considered the inclusion of IPDASi (v3.0) items as minimum standards. Item scores and qualitative comments were analyzed, followed by expert group discussion. Results. One hundred and one people voted in round 1; 87 in round 2. Forty-seven items were reduced to 44 items across 3 new categories: 1) qualifying criteria, which are required in order for an intervention to be considered a decision aid (6 items); 2) certification criteria, without which a decision aid is judged to have a high risk of harmful bias (10 items); and 3) quality criteria, believed to strengthen a decision aid but whose omission does not present a high risk of harmful bias (28 items). Conclusions. This study provides preliminary certification criteria for PDAs. Scoring and rating processes need to be tested and finalized. However, the process of appraising the quality of the clinical evidence reported by the PDA should be used to complement these criteria; the proposed standards are designed to rate the quality of the development process and shared decision-making design elements, not the quality of the PDA's clinical content.