随机临床试验和观察性试验:为个性化外科疼痛管理护理模型提供临床证据
Ivo Abraham1, Kai-Uwe Lewandrowski2,3,4, John C Elfar5
1Pharmacy Medicine, and Clinical Translational Sciences, University of Arizona, Roy P. Drachman Hall, Rm. B306H, Tucson, AZ 85721, USA.
Journal of personalized medicine
|July 29, 2023
概括
进行针对个性化外科疼痛管理的临床试验是困难的,因为在标准化程序和控制患者变量方面存在挑战. 本综述探讨了这些问题,并提出了更好的外科手术试验设计的实际解决方案.
科学领域:
- 手术研究的研究.
- 疼痛管理 疼痛管理
- 临床试验设计 临床试验设计
背景情况:
- 证明个性化手术疼痛管理的临床优越性受到手术程序固有的复杂性和可变性的阻碍.
- 在手术试验中,标准化干预,控制患者特异性因素,如并发病和解剖学,避免偏见是重大挑战.
- 样本规模小,参与者和调查人员盲目的困难进一步复杂化了个性化手术方法的评估.
研究的目的:
- 识别和审查在进行个性化外科疼痛管理的临床试验中遇到的多方面的挑战.
- 为克服这些障碍提供实际解决方案和策略,并改进外科试验的设计和执行.
- 强调需要高质量的证据来支持疼痛管理传统治疗方案的变化.
主要方法:
- 作者对现有文学和临床实践进行了全面的审查,这些实践与疼痛管理中的手术试验有关.
- 分析的重点是确定偏见的常见来源,后勤困难和针对个性化手术干预的特定伦理考虑.
- 该审查综合了这些发现,为未来的研究提出了可行的建议.
主要成果:
- 关键的挑战包括无法标准化复杂的外科手术步骤,患者群体的变化,以及有效的盲目和随机化的困难.
- 事后偏见,限制性资格标准和与患者安全相关的伦理问题可能会对试验结果产生重大影响.
- 复杂的手术干预的成本和长期后续要求增加了试验设计的复杂性.
结论:
- 克服手术试验中固有的挑战需要创新的方法和仔细考虑患者特定因素.
- 实施实际解决方案可以为个性化疼痛管理策略带来更强有力的证据.
- 高质量的证据对于在传统的基于图像的标准之外推进手术疼痛管理至关重要.
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