Boers M, Tugwell P
Department of Internal Medicine, University Hospital Maastricht, The Netherlands.
J Rheumatol. 1993 Mar;20(3):552-4.
Just prior to the OMERACT conference, participants completed a questionnaire that solicited explicit opinions on the issues discussed at the conference. The response rate was 77%. To determine the minimum level of important difference in a clinical trial comparing 2 active drugs, participants were asked to think of each of 6 separate measures in turn as designated primary outcome measure. In this situation, to decide that an important difference between the 2 groups was present, participants required a median of 20% difference in painful joints, swollen joints, and in disability, 30% in pain and patient global assessment, and 40% in physician global assessment. On each measure, between 3 to 12% of participants felt they could not decide on an important difference in that situation. Similar questions were asked for the minimum important improvement in a patient; required levels of improvement were similar but slightly higher than the responses given for trials, and more participants felt they could not decide. Correspondents indicated that acute phase reactants are also very important for assessing minimum levels of important difference and improvement in trials and patients. A large majority was in favor of applying an index of aggregated outcome measures if sensible and valid: 72% in patients, and 93% in trials.
就在OMERACT会议召开前夕，参与者完成了一份问卷，该问卷征求了对会议所讨论问题的明确意见。回复率为77%。为了确定在比较两种活性药物的临床试验中重要差异的最低水平，要求参与者依次将6项单独的测量指标中的每一项视为指定的主要结局指标。在这种情况下，为了判定两组之间存在重要差异，参与者要求在疼痛关节、肿胀关节和残疾方面有20%的中位数差异，在疼痛和患者整体评估方面有30%的差异，在医生整体评估方面有40%的差异。在每项测量指标上，有3%至12%的参与者表示在这种情况下他们无法判定是否存在重要差异。针对患者的最小重要改善也提出了类似问题；所需的改善水平相似，但略高于试验给出的回复，并且更多参与者表示他们无法判定。通讯员指出，急性期反应物对于评估试验和患者中重要差异和改善的最低水平也非常重要。绝大多数人赞成在合理且有效的情况下应用综合结局指标：患者中有72%，试验中有93%。
