Schneider H
Universitäts-Frauenklinik, Bern.
Geburtshilfe Frauenheilkd. 1996 Aug;56(8):397-400. doi: 10.1055/s-2007-1023252.
The first prospective randomised study comparing intermittent auscultation of the fetal heart rate with continuous electronic monitoring during labour and delivery, which showed an increased rate of Caesarean sections in the group with electronic monitoring without significant benefit to the newborn, met with great scepticism on the part of many perinatologists. Meanwhile, 8 additional prospective randomised trials confirmed the first results. The debate concerning the benefit and need of fetal monitoring during labour has even generated doubts regarding the need for, and benefit of, prospective randomised studies. Various study designs have been used in clinical research to test new diagnostic and therapeutic methods. Observational studies generally provide first impressions which are then strengthened by comparison of study patients with historical controls from the time before the introduction of the new method. Retrospective or prospective matched pair studies may also support the initial hypothesis. The gold standard of all designs is undoubtedly the prospective randomised trial. A double blind randomisation should be performed if feasible, in which neither the subject concerned nor the investigator are aware as to how the patient has been assigned. Only by a prospective randomised study design, known and unknown variables which may affect the outcome can be controlled and will not interfere with the assessment of the new method, since they will appear in equal measure both in the study and in the control group. In view of the rapid development of the discipline of perinatal medicine, with the evolvement of manifold new diagnostic and therapeutic methods, a critical assessment of these methods using the principle of the prospective randomised study design, is imperative. The clinical investigator has a moral obligation towards the patient to select that method which is of maximum benefit with minimum risk to the patient. In addition, in view of the drastic need for controlling expenditure in health care, it is in the interest of society that the use of methods with questionable benefit or with an unreasonable cost-benefit ratio is avoided by means of critical assessment and selection.
第一项关于分娩期间将胎儿心率间歇性听诊与连续电子监测进行比较的前瞻性随机研究表明，在电子监测组中剖宫产率有所上升，但对新生儿并无显著益处，这一研究遭到了许多围产医学专家的极大怀疑。与此同时，另外8项前瞻性随机试验证实了最初的结果。关于分娩期间胎儿监测的益处和必要性的争论甚至引发了对前瞻性随机研究的必要性和益处的质疑。临床研究中使用了各种研究设计来测试新的诊断和治疗方法。观察性研究通常提供初步印象，然后通过将研究患者与新方法引入之前的历史对照进行比较来强化这些印象。回顾性或前瞻性配对研究也可能支持最初的假设。所有设计的金标准无疑是前瞻性随机试验。如果可行，应进行双盲随机化，即相关受试者和研究者都不知道患者是如何被分配的。只有通过前瞻性随机研究设计，才能控制可能影响结果的已知和未知变量，并且这些变量不会干扰对新方法的评估，因为它们将在研究组和对照组中以相等的程度出现。鉴于围产医学学科的快速发展，随着众多新诊断和治疗方法的不断涌现，使用前瞻性随机研究设计的原则对这些方法进行批判性评估势在必行。临床研究人员对患者负有道德义务，要选择对患者益处最大且风险最小的方法。此外，鉴于控制医疗保健支出的迫切需求，通过批判性评估和选择来避免使用益处存疑或成本效益比不合理的方法，这符合社会的利益。
