Risk Management, Validation, Regulation, Haifa, Israel.
Zefat Academic College, Zefet, Israel.
Drug Deliv. 2022 Dec;29(1):1754-1763. doi: 10.1080/10717544.2022.2080889.
Current literature lacks structured methodologies for analyzing medical technologies' impact from the patient-centered care perspective. This study introduces, applies and validates 'Patient-Centered Care Impact Analysis' (PCIA) as a method for identifying patient-centered care associated demands and expectations for a particular technology and assessing its compliance with these demands. PCIA involves five stages: (1) demand identification, (2) ranking demands' impact magnitude, (3) scoring demand compliance (DC), (4) demand priority (DP) assignment based on impact magnitude and compliance, (5) generating a summative impact priority number (IPN). PCIA was performed as a comparative assessment of two central nervous system (CNS) drug-delivery platforms; SipNose, a novel noninvasive Direct-Nose-to-Brain (DNTB), vs. the standard-of-care invasive intrathecal/intracerebroventricular injection (Invasive I/I). Study participants included a ranking team (RT) without experience with the SipNose technology that based their scoring on experimental data; and a validation team (VT) experienced with the SipNose platform. All had experience with, or knowledge of, InvasiveI/I. Demand identification and impact magnitude were performed by one content and one assessment expert. Each participant assessed each technology's DC. DP scores, IPN's and IPN DNTB:InvasiveI/I ratios were generated for each technology, for each team, based on DC and summative DP scores, respectively. Both teams assigned DNTB higher DC scores, resulting in higher DNTB DP, IPN scores and DNTB:InvasiveI/I IPN ratios. Lack of difference between team assessments of DP and IPN ratio validate PCIA as an assessment tool capable of predicting patient-centered clinical care quality for a new technology. The significant differences between the platforms highlight SipNose's patient-care centered advantages as an effective CNS drug-delivery platform.
目前的文献缺乏从以患者为中心的护理角度分析医疗技术影响的结构化方法。本研究介绍、应用和验证了“以患者为中心的护理影响分析”（PCIA）方法，用于确定特定技术相关的以患者为中心的护理需求和期望，并评估其对这些需求的符合程度。PCIA 包括五个阶段：（1）需求识别，（2）需求影响程度的排名，（3）需求符合程度的评分（DC），（4）根据影响程度和符合程度分配需求优先级（DP），（5）生成综合影响优先级数（IPN）。PCIA 作为两种中枢神经系统（CNS）药物输送平台的比较评估，SipNose 是一种新型的无创直接鼻内脑输送（DNTB），与标准的侵入性鞘内/脑室内注射（Invasive I/I）相比。研究参与者包括一个没有 SipNose 技术经验的排名团队（RT），他们根据实验数据进行评分；以及一个有 SipNose 平台经验的验证团队（VT）。所有人都有侵入性 I/I 的经验或知识。需求识别和影响程度由一名内容和一名评估专家进行。每位参与者评估了每种技术的 DC。DP 分数、IPN 和 IPN DNTB:InvasiveI/I 比值是根据 DC 和综合 DP 分数分别为每种技术、每个团队生成的。两个团队都为 DNTB 分配了更高的 DC 分数，从而为 DNTB 获得了更高的 DP、IPN 分数和 DNTB:InvasiveI/I IPN 比值。团队对 DP 和 IPN 比值的评估缺乏差异，验证了 PCIA 作为一种评估工具的有效性，能够预测新技术的以患者为中心的临床护理质量。两个平台之间的显著差异突出了 SipNose 作为一种有效的 CNS 药物输送平台的以患者为中心的护理优势。
