Demerjian Garabed G, Barkhordarian Andre, Chiappelli Francesco
Oral Biology & Medicine, Center for the Health Sciences UCLA, Los Angeles, USA.
Center for TMJ and Sleep Therapy, Glendora, CA, USA.
J Transl Med. 2016 Aug 2;14(1):231. doi: 10.1186/s12967-016-0991-9.
Traditional research in the health sciences has involved control and experimental groups of patients, and descriptive and inferential statistical analyses performed on the measurements obtained from the samples in each group. As the novel model of translational healthcare, which integrates translational research and translational effectiveness, becomes increasingly established in modern contemporary medicine, healthcare continues to evolve into a model of care that is evidence-based, effectiveness-focused and patient-centered. Patient-centered care and patient-targeted therapies require the timely and critical development and validation of a new research paradigm, individual patient research (IPR), as opposed to the customary group research approach. Here, we propose a model of individual patient research to define and characterize the effectiveness of a novel therapeutic intervention for temporomandibular joint disorder. The intervention must be tailor-made for each individual patient, and the data from each patient must be analyzed individually. We propose that this endeavor is best achieved by means of an adaptive cluster randomized stepped wedge blinded controlled trial, because it permit individual patient outcomes research and analysis, ensures equipoise, and maintains adequate power. The patient targeted therapies section of the Journal of Translational Medicine must endeavor to facilitate the dissemination of studies that focus broadly on translational research for the ultimate benefit of individual patients.
健康科学领域的传统研究涉及患者的对照组和试验组,并对从每组样本中获得的测量数据进行描述性和推断性统计分析。随着整合转化研究与转化效果的新型转化医疗模式在现代医学中日益确立,医疗保健正不断演变为一种基于证据、注重效果且以患者为中心的护理模式。以患者为中心的护理和针对患者的治疗需要及时且关键地开发和验证一种新的研究范式,即个体患者研究(IPR),以取代传统的群体研究方法。在此,我们提出一种个体患者研究模型,以界定和描述一种针对颞下颌关节紊乱的新型治疗干预措施的效果。该干预措施必须为每个个体患者量身定制,且每个患者的数据必须单独进行分析。我们认为,通过适应性整群随机阶梯楔形盲法对照试验能够最好地实现这一目标,因为它允许进行个体患者结局研究与分析,确保了均衡性,并保持了足够的效能。《转化医学杂志》的“针对患者的治疗”板块必须致力于促进广泛关注转化研究以最终造福个体患者的研究成果的传播。