Doig G S
Department of Medicine, University of Western Ontario, London, Canada.
Crit Care Clin. 1998 Jul;14(3):513-24. doi: 10.1016/s0749-0704(05)70014-2.
In 1754, aboard HMS Salisbury, James Lind conducted a simple, controlled clinical trial. He took 12 patients with "pale and bloated skin, listlessness, an aversion to exercise, swollen gums, halitosis, ecchymotic mucous membranes, and limb edema" and allocated them to receive treatment with one of six different therapies. Since the patients receiving two of his six chosen interventions had such a dramatic recovery, he felt ethically obligated to end his trial and administer these treatments to all the remaining sailors. Today we fully recognize the impact that the controlled clinical trial can have on the development of new interventions. Unfortunately, very few of these interventions are likely to have as dramatic an impact on outcomes as lemons and oranges did on scurvy. Because the interventions we study tend to have relatively small treatment effects, and because the design and reporting of published RCTs has consistently been documented to be less than perfect, there is a real need for us to develop critical appraisal skills. This article is by no means the only approach to critical appraisal, but hopefully it serves as an adequate starting point for the journey.
1754年，詹姆斯·林德在皇家海军索尔兹伯里号军舰上进行了一项简单的对照临床试验。他选取了12名患有“皮肤苍白且肿胀、无精打采、厌恶运动、牙龈肿胀、口臭、粘膜瘀斑和肢体水肿”的患者，并将他们分配接受六种不同疗法中的一种治疗。由于接受他所选择的六种干预措施中的两种治疗的患者恢复情况显著，他认为从伦理角度有义务结束试验，并将这些治疗方法应用于所有剩余的水手。如今，我们充分认识到对照临床试验对新干预措施发展的影响。不幸的是，这些干预措施中很少有能像柠檬和橙子对坏血病那样对治疗结果产生如此显著的影响。因为我们研究的干预措施往往治疗效果相对较小，而且因为已发表的随机对照试验的设计和报告一直被证明不够完善，所以我们确实需要培养批判性评估技能。本文绝不是批判性评估的唯一方法，但希望它能成为这一旅程的一个适当起点。
