Drolet Brian C, Lorenzi Nancy M
Department of Plastic and General Surgery, Alpert Medical School, Brown University, Providence, Rhode Island 02903, USA.
J Craniofac Surg. 2012 Jan;23(1):301-3. doi: 10.1097/SCS.0b013e318241dbee.
Evidence-based medicine is a vital process for maintaining and improving quality and value in health care. However, evidence-based practice is most limited by the availability of research and outcomes data. Although randomized controlled trials (RCTs) have been identified by numerous research organizations as the criterion standard for research methodology (eg, "level I evidence"), the execution of well-designed RCTs has proved either challenging or impossible in many surgical fields and with rare disease conditions. In particular, craniofacial and plastic surgery has been noted to be lacking in both the number and quality of RCTs. Many reasons are discussed for this dearth of research including inadequate sample size and challenges in randomization, blinding, and clinical equipoise. Yet, data for outcomes assessment are highly valued by surgeons and by consumers and payers. Therefore, alternative and more practical means for research and data collection must be sought. Observational studies of clinical practice are particularly useful for outcomes assessment despite relegation to a lower tier of evidence (eg, "level II evidence"). Functional databases with well-defined processes for data collection, called medical data registries, are an essential informatics tool to collect and store outcomes data and produce high-quality observational, practice-based research studies. A properly designed and implemented registry can provide surgeons with an abundance of data to perform research and quality improvement projects. In fact, registries may be superior in many ways to RCTs for craniofacial and plastic surgeons both pragmatically and functionally. In this commentary, we discuss the production of such registries in the framework of evidence-based practice and the relevant studies in craniofacial surgery.
循证医学是维持和提高医疗保健质量与价值的关键过程。然而，循证实践在很大程度上受到研究和结果数据可用性的限制。尽管许多研究机构已将随机对照试验（RCT）确定为研究方法的标准（例如，“一级证据”），但在许多外科领域以及罕见病情况下，实施精心设计的RCT已被证明具有挑战性或根本无法实现。特别是，颅面外科和整形外科在RCT的数量和质量方面都存在不足。对于这种研究匮乏，人们讨论了许多原因，包括样本量不足以及随机化、盲法和临床 equipoise 方面的挑战。然而，结果评估数据受到外科医生、消费者和支付方的高度重视。因此，必须寻求替代的、更实用的研究和数据收集方法。尽管临床实践观察性研究被归类为较低级别的证据（例如，“二级证据”），但它对于结果评估特别有用。具有明确数据收集流程的功能数据库，即医学数据登记处，是收集和存储结果数据以及开展高质量观察性、基于实践的研究的重要信息学工具。一个设计和实施得当的登记处可以为外科医生提供大量数据，以开展研究和质量改进项目。事实上，对于颅面外科和整形外科医生来说，登记处在实用性和功能性方面可能在许多方面优于RCT。在本评论中，我们将在循证实践的框架内讨论此类登记处的建立以及颅面外科的相关研究。
