Mosis Georgio, Dieleman Jeanne P, Stricker Bruno Ch, van der Lei Johan, Sturkenboom Miriam C J M
Department Medical Informatics, Erasmus University Medical Center, P.O. Box 1738, 30000 DR Rotterdam, The Netherlands.
J Clin Epidemiol. 2006 May;59(5):497-502. doi: 10.1016/j.jclinepi.2005.11.007. Epub 2006 Mar 13.
To assess patient recruitment and quality of data in a randomized database study.
A randomized database study was conducted in the Integrated Primary Care Information (IPCI) general practice research database. Software was built to allow for automated patient identification and recruitment, and randomization. As an application, we compared gastrointestinal tolerability in persons treated with diclofenac and celecoxib for osteoarthritis. The outcomes were assessed in the IPCI database. To assess accuracy of exposure and outcome, we also collected information by self-administrated patient questionnaires. For all eligible subjects, we assessed the main reason for noninclusion. Physicians were interviewed to evaluate the study and to identify the major obstacles.
Forty-two general practice physicians collaborated with the study and 7,127 potential study subjects were identified. Among these subjects, 170 were eligible for recruitment and 20 (11.8%) were randomized. Of the eligible patients, 96 (56.5%) were not recruited because the physician was too busy or the patient was treated by another healthcare provider and 54 (31.8%) were not recruited because of exclusion criteria.
Concordance between questionnaires and IPCI data and the outcome was good (kappa=0.7; SD=0.14). The physicians reported that recruitment during routine visits was too time-consuming, in particular because of the need for informed consent. Although a randomized database study is feasible, patient recruitment during routine consultations should be avoided.
在一项随机数据库研究中评估患者招募情况及数据质量。
在综合初级保健信息（IPCI）全科医疗研究数据库中进行了一项随机数据库研究。开发了软件以实现患者的自动识别、招募和随机分组。作为一项应用，我们比较了双氯芬酸和塞来昔布治疗骨关节炎患者的胃肠道耐受性。在IPCI数据库中评估结局。为评估暴露和结局的准确性，我们还通过患者自行填写的问卷收集信息。对于所有符合条件的受试者，我们评估了未纳入的主要原因。对医生进行访谈以评估该研究并确定主要障碍。
42名全科医生参与了该研究，共识别出7127名潜在研究对象。在这些对象中，170名符合招募条件，20名（11.8%）被随机分组。在符合条件的患者中，96名（56.5%）未被招募是因为医生太忙或患者由其他医疗服务提供者治疗，54名（31.8%）未被招募是因为排除标准。
问卷与IPCI数据及结局之间的一致性良好（kappa = 0.7；标准差 = 0.14）。医生报告称，在常规就诊期间进行招募耗时过长，尤其是因为需要获取知情同意书。尽管随机数据库研究是可行的，但应避免在常规会诊期间进行患者招募。
