Roberts C T, Semb G, Shaw W C
University Dental Hospital Manchester, England.
Cleft Palate Craniofac J. 1991 Apr;28(2):141-9. doi: 10.1597/1545-1569_1991_028_0141_sftaos_2.3.co_2.
This paper examines the clinical research methodologies used for the evaluation of cleft lip and palate therapies. A survey of clinical reports in the Cleft Palate Journal between 1964 and 1988 revealed that almost all used retrospective methods (96%). The authors examine the merits and biases associated with retrospective evaluation of therapies and compared these to prospective randomized clinical trials. The strengths and weaknesses of clinical trials are discussed in relation to the long-term evaluation of primary surgery in cleft patients. For these to be successful, further work is needed to investigate questions such as sample size, possible predictors of long-term outcome, and improved methods of presurgical assessment. The authors conclude that if the uncertainties associated with the choice of primary cleft surgery are to be resolved, the challenge of multicenter prospective clinical trials must be faced by the various disciplines involved in cleft palate clinical research.
本文探讨了用于评估唇腭裂治疗方法的临床研究方法。对1964年至1988年期间《腭裂杂志》上的临床报告进行的一项调查显示，几乎所有报告都采用了回顾性方法（96%）。作者研究了与治疗方法回顾性评估相关的优点和偏差，并将其与前瞻性随机临床试验进行了比较。结合腭裂患者一期手术的长期评估，讨论了临床试验的优缺点。为了使这些评估取得成功，需要
进一步开展
工作来研究诸如样本量、长期结果的可能预测因素以及改进的术前评估方法等问题。作者得出结论，如果
要解决与
腭裂一期手术选择相关的不确定性问题
，
参与腭裂
临床研究
的
各个学科
必须
面对多中心前瞻性
临床试验的挑战
。
