Shi Yuan, Chen Yan-Ru, Chen Long
Department of Neonatology, Children's Hospital of Chongqing Medical University, Chongqing 400014, China.
Zhongguo Dang Dai Er Ke Za Zhi. 2018 Mar;20(3):169-173. doi: 10.7499/j.issn.1008-8830.2018.03.001.
Real world study (RWS) has attracted more and more attention of neonatologists since it involves less clinical intervention and is closer to actual clinical conditions. Generally speaking, RWS means to select treatment measures based on the internal efficacy and safety verified by randomized controlled trials (RCTs), more representative samples, and patients' actual conditions and their guardians' will and conduct follow-up evaluation of short- and long-term outcomes, in order to further evaluate the external efficacy and safety of interventional measures. Most guidelines for clinical practice are based on RCTs and lack the support of real world data. Strengthening of neonatal RWS helps to make these guidelines more practical and thus promotes the development of neonatal medicine.
真实世界研究(RWS)因其临床干预较少且更贴近实际临床情况,已越来越受到新生儿科医生的关注。一般来说,真实世界研究是指基于随机对照试验(RCT)验证的内在疗效和安全性、更具代表性的样本、患者的实际情况及其监护人的意愿来选择治疗措施,并对短期和长期结局进行随访评估,以进一步评估干预措施的外在疗效和安全性。大多数临床实践指南基于随机对照试验,缺乏真实世界数据的支持。加强新生儿真实世界研究有助于使这些指南更具实用性,从而推动新生儿医学的发展。