Division of Clinical Neuroscience, University of Nottingham, Queen's Medical Centre, Nottingham, UK.
Department of Anaesthesia, Sheffield Teaching Hospitals, Sheffield, UK.
Anaesthesia. 2020 Jun;75(6):809-815. doi: 10.1111/anae.14967. Epub 2020 Feb 5.
The applicability of the results of any clinical trial will depend to a large extent on whether the study population is representative of the population seen in clinical practice. The growing older surgical population presents challenges for peri-operative researchers to ensure there is adequate representation of patients in terms of their age, sex, race and ethnicity in clinical trials. A review of purposively sampled published randomised controlled trials was performed to establish the age, sex, race and ethnicity of study participants. These data were compared with national registry data for the relevant surgical populations. We included 224 peri-operative trials that were cited in 469 retrieved meta-analyses. Of these, 50 (22.3%) had an upper age limit to recruitment. The median (range [IQR]) difference in study population age from the registry population age was: -2.4 (-6.2 to 1.0 [-34.7 to 14.5]) years for all randomised controlled trials; -6.2 (-9.4 to -2.8 [-18.6 to 4.6]) years for randomised controlled trials of patients undergoing hip arthroplasty; and -3.4 (-9.6 to -1.1 [-34.7 to 2.9]) years for randomised controlled trials of patients undergoing hip fracture surgery. In 92 (41.1%) randomised controlled trials, the proportion of each sex in the study population was more than 25% different from the proportion in the registry population. Only 5 (2.2%) trials published data on the race or ethnicity of participants. We conclude that peri-operative randomised controlled trials are unlikely to be representative of the age and sex of clinically treated surgical populations. Researchers must endeavour to ensure representative study populations are recruited to future clinical trials.
研究结果的适用性在很大程度上取决于研究人群是否具有代表性，即是否与临床实践中所见的人群具有代表性。随着手术人群年龄的增长，围手术期研究人员面临着挑战，需要确保临床试验中患者在年龄、性别、种族和民族方面有足够的代表性。为此，我们对有目的抽样的已发表的随机对照试验进行了综述，以确定研究参与者的年龄、性别、种族和民族。然后将这些数据与相关手术人群的国家登记数据进行比较。我们纳入了 224 项围手术期试验，这些试验被引用在 469 项检索到的荟萃分析中。其中，50 项（22.3%）试验对入组有最高年龄限制。研究人群的年龄中位数（范围[IQR]）与登记人群的年龄差异为：所有随机对照试验为-2.4（-6.2 至 1.0[-34.7 至 14.5]）岁；髋关节置换术随机对照试验为-6.2（-9.4 至-2.8[-18.6 至 4.6]）岁；髋关节骨折手术随机对照试验为-3.4（-9.6 至-1.1[-34.7 至 2.9]）岁。在 92 项（41.1%）随机对照试验中，研究人群中每个性别的比例与登记人群的比例相差超过 25%。只有 5 项（2.2%）试验公布了参与者种族或民族的数据。我们的结论是，围手术期随机对照试验不太可能代表临床治疗的手术人群的年龄和性别。研究人员必须努力确保在未来的临床试验中招募到有代表性的研究人群。
