Département de Pharmacologie, Université Victor Segalen, Bordeaux, France.
Pharmacoepidemiol Drug Saf. 2010 May;19(5):474-81. doi: 10.1002/pds.1951.
Various data sources may be used in pharmacoepidemiological studies. When they cannot be obtained from valid databases, medical data must be obtained from physicians or patients. In the CADEUS study, both patients and their prescribers reported medical data allowing investigation of the concordance between these sources.
CADEUS is a French national cohort study of traditional non-steroidal anti-inflammatory drug (NSAID) and coxib users conducted between September 2003 and August 2004 in France that employed self-administered questionnaires to obtain medical data from patients and their prescribers. The Kappa statistic (kappa) was used to measure concordance between patients and prescribers in 18 530 pairs with regard to previous medical history and index NSAID indication.
For previous medical history, the proportion of agreement ranged from 70.7 to 99.2% and concordance was: substantial (kappa = 0.61-0.80) for hypertension, myocardial infarction, stroke and diabetes; moderate (kappa = 0.41-0.60) for angina pectoris, peripheral arterial disease and hypercholesterolaemia; fair (kappa = 0.21-0.40) for unstable angina, cardiac insufficiency, dyspepsia, gastroesophageal reflux and gastric ulcer; slight (kappa < 0.21) for upper gastrointestinal haemorrhage. For index NSAID indication, the proportion of agreement ranged from 84.3 to 99.4% and concordance was almost perfect (kappa = 0.81-1.00) for inflammatory rheumatism, flu-like symptoms, dysmenorrhoea and dental pain; substantial for arthritis, back pain and headache; moderate for osteoarticular pain.
Concordance was better for specific or serious conditions both regarding previous medical history and indication. Prescriber or patient perception and understanding may reduce concordance for certain items.
在药物流行病学研究中，可以使用各种数据源。当无法从有效数据库中获得数据时，必须从医生或患者那里获取医疗数据。在 CADEUS 研究中，患者及其处方医生均报告了医疗数据，从而可以调查这两种数据源之间的一致性。
CADEUS 是一项法国全国性队列研究，研究对象为 2003 年 9 月至 2004 年 8 月期间使用传统非甾体抗炎药（NSAID）和昔布类药物的患者，采用自填式问卷从患者及其处方医生处获取医疗数据。采用 Kappa 统计量（kappa）衡量 18530 对患者和处方医生关于既往病史和 NSAID 适应证的一致性。
在既往病史方面，一致性比例范围为 70.7%至 99.2%，一致性程度为：高血压、心肌梗死、中风和糖尿病为高度一致（kappa=0.61-0.80）；心绞痛、外周动脉疾病和高胆固醇血症为中度一致（kappa=0.41-0.60）；不稳定型心绞痛、心功能不全、消化不良、胃食管反流和胃溃疡为轻度一致（kappa=0.21-0.40）；上消化道出血为不一致（kappa<0.21）。在 NSAID 适应证方面，一致性比例范围为 84.3%至 99.4%，一致性程度为：炎症性风湿病、流感样症状、痛经和牙痛为高度一致（kappa=0.81-1.00）；关节炎、背痛和头痛为中度一致（kappa=0.61-0.80）；骨关节炎疼痛为轻度一致（kappa=0.41-0.60）。
既往病史和适应证的特定或严重疾病的一致性更好。对于某些项目，处方医生或患者的感知和理解可能会降低一致性。
