PRESKORN and ARMSTRONG: Department of Psychiatry and Behavioral Sciences, University of Kansas School of Medicine-Wichita, Wichita, KS.
J Psychiatr Pract. 2023 Mar 1;29(2):137-141. doi: 10.1097/PRA.0000000000000701.
This column provides some criteria for evaluating whether a case series or case report may warrant publication. It will emphasize the value of having biomarker data in addition to clinical data to enhance the potential validation of the report and provide ways to test the findings in randomized, controlled clinical trials (RCTs). The potential validity of the case series or report is also high if the outcome is something that would not normally be expected such as, by way of example but not limited to, sudden death or malignant hypertension in someone who had always been normotensive. Examples illustrating how case series/case reports have changed the course of clinical practice or regulatory rules governing drug approval by the US Food and Drug Administration are presented, as well as examples of how those reports have been validated by more rigorous studies including RCTs. The column also includes a discussion of situations in which case series/case reports might have an endpoint (eg, sudden death) that would not be ethical to investigate in an RCT, as well as how biomarkers have been used in such instances to avoid serious untoward outcomes for a participant while still testing the hypothesis.
本专栏提供了一些评估病例系列或病例报告是否值得发表的标准。它将强调除了临床数据外，拥有生物标志物数据的价值，以增强报告的潜在验证，并提供在随机对照临床试验 (RCT) 中检验发现的方法。如果结果是不寻常的，例如，通过举例但不限于，一直正常血压的人突然死亡或恶性高血压，那么病例系列或报告的潜在有效性也很高。本文介绍了病例系列/病例报告如何改变临床实践或美国食品和药物管理局 (FDA) 监管药物批准规则的例子，以及这些报告如何通过更严格的研究（包括 RCT）进行验证的例子。该专栏还讨论了在 RCT 中研究病例系列/病例报告的终点（例如，突然死亡）可能不道德的情况，以及在这种情况下如何使用生物标志物来避免参与者出现严重不良后果，同时仍检验假设。
