Mendelsohn Aaron B, Dreyer Nancy A, Mattox Pattra W, Su Zhaohui, Swenson Anna, Li Rui, Turner J Rick, Velentgas Priscilla
1 Quintiles, Real-World & Late Phase Research, Cambridge, MA, USA.
2 Quintiles, Clinical Communications, NC, USA.
Ther Innov Regul Sci. 2015 Jan;49(1):146-154. doi: 10.1177/2168479014532259.
Patterns of missing data are seldom well-characterized in observational research. This study examined the magnitude of, and factors associated with, missing data across multiple observational studies. Missingness was evaluated for demographic, clinical, and patient-reported outcome (PRO) data from a procedure registry (TOPS), a rare disease (cystic fibrosis) registry (Port-CF), and a comparative effectiveness registry (glaucoma, RiGOR). Generalized linear mixed effects models were fit to assess whether patient characteristics or follow-up methods predicted missingness. Data from 156,707 surgical procedures, 32,118 cystic fibrosis patients, and 2373 glaucoma patients were analyzed. Data were rarely missing for demographics, treatments, and outcomes. Missingness for clinical variables varied by registry and measure and depended on whether a variable was required. Within RiGOR, PRO forms were missing more often when collected by e-mail compared with office-based paper data collection. In Port-CF, missingness varied based on insurance status and sex. Strategic consideration of operational approaches affecting missing data should be performed prior to data collection and assessed periodically during study conduct.
在观察性研究中，缺失数据的模式很少得到充分描述。本研究调查了多项观察性研究中缺失数据的规模以及与之相关的因素。对来自一个手术登记处（TOPS）、一个罕见病（囊性纤维化）登记处（Port-CF）和一个比较疗效登记处（青光眼，RiGOR）的人口统计学、临床和患者报告结局（PRO）数据的缺失情况进行了评估。采用广义线性混合效应模型来评估患者特征或随访方法是否能预测数据缺失情况。对156,707例外科手术、32,118例囊性纤维化患者和2373例青光眼患者的数据进行了分析。人口统计学、治疗和结局数据很少缺失。临床变量的缺失情况因登记处和测量指标而异，并取决于某个变量是否为必需变量。在RiGOR中，与基于办公室的纸质数据收集相比，通过电子邮件收集PRO表格时，缺失情况更为常见。在Port-CF中，缺失情况因保险状况和性别而异。在数据收集之前，应对影响缺失数据的操作方法进行策略性考虑，并在研究进行期间定期进行评估。
