Comparative effectiveness research in critically ill patients: risks associated with mischaracterising usual care.
Comparative effectiveness research in critically ill patients: risks associated with mischaracterising usual care.
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DOI：
10.51893/2020.2.r1
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发表时间：
2020-06
期刊：
影响因子：
--
通讯作者：
Natanson C
中科院分区：
文献类型：
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作者：
Applefeld WN;Wang J;Klein HG;Danner RL;Eichacker PQ;Natanson C
比较有效性研究可以帮助指导使用常见的常规医疗实践。然而，为了安全和提供信息，此类试验必须包括至少一个准确描述当前做法的治疗组。虽然比较有效性研究被广泛认为是安全的，没有或只有最小的风险，但如果在一个或多个研究组中存在未被认识到的与常规护理的偏差，这些假设可能不成立。特别是对于危重病人，这种做法偏差可能会增加死亡或受伤的风险，并破坏安全监测。此外，未被认可的不寻常护理似乎可能会破坏知情同意文件，在令人放心的“相对有效性”研究标签下，低估的风险被掩盖了。目前，监督措施不足以确保参加比较有效性试验的研究对象实际上得到通常而不是不寻常的护理。具有适当专业知识的政府和非政府实体的监督，有权确保目前的临床实践得到适当代表，可以帮助防止在临床试验中出现伪装成常规护理的不寻常护理。
Comparative effectiveness research can help guide the use of common, routine medical practices. However, to be safe and informative, such trials must include at least one treatment arm that accurately portrays current practices. While comparative effectiveness research is widely perceived as safe and to involve no or only minimal risks, these assumptions may not hold true if unrecognised deviations from usual care exist in one or more study arms. For critically ill subjects in particular, such practice deviations may increase the risk of death or injury and undermine safety monitoring. Furthermore, unrecognised unusual care seems likely to corrupt informed consent documents, with underappreciated risks shrouded under the reassuring "comparative effectiveness" research label. At present, oversight measures are inadequate to ensure that research subjects enrolled in comparative effectiveness trials are actually receiving usual and not unusual care. Oversight by governmental and non-governmental entities with appropriate expertise, empowered to ensure that current clinical practice has been properly represented, could help prevent occurrences in clinical trials of unusual care masquerading as usual care.