Ootes Daan, Buijze Geert A, Ring David
Orthopaedic Hand and Upper Extremity Service, Massachusetts General Hospital, Harvard Medical School, Yawkey Center, Suite 2100, 55 Fruit Street, Boston, MA 02114 USA.
Hand (N Y). 2012 Jun;7(2):177-80. doi: 10.1007/s11552-012-9411-7.
Missed research appointments may bias the outcome of prospective clinical trials if the participants that miss appointments differ in important ways from those that do not. The purpose of this study was to determine the predictors of missed research appointments in patients enrolled in clinical trials.
We retrospectively evaluated 665 participants enrolled in ten prospective clinical trials conducted at our outpatient office between 2001 and 2010. Demographic data (sex, race, date of birth, date of enrollment, age at enrollment, educational level, and work status), study coordinator, and study type were analyzed for association with missed a research appointment in bivariate and multiple logistic regression analyses.
One hundred and forty-four (21.7 %) participants missed research appointments during their follow-up. There were no statistical differences between those who missed appointments and those who did not, regarding sex, race, and age at enrollment. Educational level and work status were independent predictors of missed appointments.
This study suggests that educational level and work status are predictors of missed appointments in prospective clinical research.
如果错过研究预约的参与者与未错过的参与者在重要方面存在差异,那么错过研究预约可能会使前瞻性临床试验的结果产生偏差。本研究的目的是确定参与临床试验的患者错过研究预约的预测因素。
我们回顾性评估了2001年至2010年在我们门诊进行的十项前瞻性临床试验中的665名参与者。在双变量和多因素逻辑回归分析中,分析了人口统计学数据(性别、种族、出生日期、入组日期、入组时年龄、教育程度和工作状态)、研究协调员和研究类型与错过研究预约之间的关联。
144名(21.7%)参与者在随访期间错过研究预约。在错过预约者与未错过预约者之间,在性别、种族和入组时年龄方面无统计学差异。教育程度和工作状态是错过预约的独立预测因素。
本研究表明,教育程度和工作状态是前瞻性临床研究中错过预约的预测因素。