Darsaut Tim E, Raymond Jean
Mackenzie Health Sciences Centre, Department of Surgery, Division of Neurosurgery, University of Alberta Hospital, 8440 - 112 Street, Edmonton, Alberta, T6G 2B7, Canada.
Department of Radiology, Service of Interventional Neuroradiology, Centre Hospitalier de l'Université de Montréal - CHUM, 1000 St-Denis, room D03-5462B, Montreal, QC, H2X 0C1, Canada.
Trials. 2021 Feb 15;22(1):143. doi: 10.1186/s13063-021-05084-0.
The current research-care separation was introduced to protect patients from explanatory studies designed to gain knowledge for future patients. Care trials are all-inclusive pragmatic trials integrated into medical practice, with no extra tests, risks, or cost, and have been designed to guide practice under uncertainty in the best medical interest of the patient.
Patients need a distinction between validated care, previously verified to provide better outcomes, and promising but unvalidated care, which may include unnecessary or even harmful interventions. While validated care can be practiced normally, unvalidated care should only be offered within declared pragmatic care research, designed to protect patients from harm. The validated/unvalidated care distinction is normative, necessary to the ethics of medical practice. Care trials, which mark the distinction and allow the tentative use of promising interventions necessarily involve patients, and thus the design and conduct of pragmatic care research must respect the overarching rule of care ethics "to always act in the best medical interest of the patient." Yet, unvalidated interventions offered in contexts of medical uncertainty cannot be prescribed or practiced as if they were validated care. The medical interests of current patients are best protected when unvalidated practices are restricted to a care trial protocol, with 1:1 random allocation (or "hemi-prescription") versus previously validated care, to optimize potential benefits and minimize risks for each patient.
Pragmatic trials can regulate medical practice by providing (i) a transparent demarcation between unvalidated and validated care; (ii) norms of medical conduct when using tests and interventions of yet unknown benefits in practice; and eventually (iii) a verdict regarding optimal care.
当前引入的研究与医疗分离旨在保护患者免受旨在为未来患者获取知识的解释性研究的影响。医疗试验是融入医疗实践的全面务实试验，没有额外的检查、风险或成本，其设计目的是在不确定性情况下以患者的最佳医疗利益为导向指导实践。
患者需要区分经过验证的医疗（先前已证实能带来更好的治疗效果）和有前景但未经验证的医疗，后者可能包括不必要甚至有害的干预措施。虽然经过验证的医疗可以正常实施，但未经验证的医疗仅应在已声明的务实医疗研究范围内提供，旨在保护患者免受伤害。经过验证/未经验证的医疗区分是规范性的，对于医疗实践的伦理来说是必要的。医疗试验标志着这种区分，并允许暂时使用有前景的干预措施，必然涉及患者，因此务实医疗研究的设计和实施必须遵循医疗伦理的首要规则“始终以患者的最佳医疗利益行事”。然而，在医疗不确定性情况下提供的未经验证的干预措施不能像经过验证的医疗那样被开出处方或实施。当未经验证的做法仅限于医疗试验方案，与先前经过验证的医疗进行1:1随机分配（或“半处方”）时，当前患者的医疗利益能得到最佳保护，以优化每个患者的潜在益处并将风险降至最低。
务实试验可以通过提供以下几点来规范医疗实践：（i）在未经验证和经过验证的医疗之间进行透明的划分；（ii）在实践中使用益处尚不明的检查和干预措施时的医疗行为规范；最终（iii）关于最佳医疗的判定。
