Imrey P B, Chilton N W
Task Force on Design and Analysis, Inc., Lawrenceville, NJ.
J Periodontol. 1992 Dec;63(12 Suppl):1124-40. doi: 10.1902/jop.1992.63.12s.1124.
Aspects of the design and analysis of periodontal clinical trials are surveyed from a biostatistical perspective. Design issues discussed include protocol preparation, subject selection and its documentation, randomization, problems associated with the sample versus population paradigm in sampling of microbes and gingival fluid constituents, quality control, cross-over and split-mouth versus parallel-arm designs, blinding, and multicenter trials. Analytic discussion deals with the definition and choice of analytic unit, appropriate methods for the analysis of data from multiple sites within the same subject, the nature and application of randomization tests, interim analyses, subgroup analyses, and multiple comparison issues. Examples are provided to illustrate the feasibility of analyzing site-specific data while accounting for intra-subject correlation, which represents the increased similarity of sites chosen from the same mouth as compared to sites from different patients.
从生物统计学角度审视了牙周临床试验的设计与分析的各个方面。讨论的设计问题包括方案制定、受试者选择及其记录、随机化、微生物和龈沟液成分采样中样本与总体范式相关的问题、质量控制、交叉设计和分口设计与平行组设计、盲法以及多中心试验。分析讨论涉及分析单位的定义和选择、同一受试者内多个部位数据的合适分析方法、随机化检验的性质和应用、中期分析、亚组分析以及多重比较问题。提供了示例以说明在考虑受试者内相关性的情况下分析特定部位数据的可行性，受试者内相关性表示与不同患者的部位相比，从同一口腔中选取的部位具有更高的相似性。
