Fourrier-Réglat Annie, Droz-Perroteau Cécile, Bénichou Jacques, Depont Fanny, Amouretti Michel, Bégaud Bernard, Moride Yola, Blin Patrick, Moore Nicholas
INSERM, Unité 657, IFR 99, Bordeaux, France.
Epidemiology. 2008 Mar;19(2):186-90. doi: 10.1097/EDE.0b013e31816326e9.
In pharmacoepidemiology studies where patients are selected by prescribers, there is concern that the patients of responding prescribers are not necessarily an unbiased sample of all patients. However, this usually cannot be explored. In the CADEUS study, patients and prescribers were independently contacted so that data are available for patients irrespective of whether their prescriber responded or not. Our objective was to compare the characteristics of patients whose prescriber did or did not respond.
The CADEUS study included patients treated with COX-2 inhibitors (celecoxib, rofecoxib) or traditional NSAIDs from September 2003 to August 2004. Redeemed prescriptions were randomly sampled on a monthly basis within the database of the French national healthcare insurance system for salaried persons during 1 year. Patients and prescribers were questioned independently. Data from patients and from the database were used to compare patients whose prescriber responded and those whose prescriber did not.
Of 45,217 patients, 26,618 had prescriber data. Patients whose prescriber responded were similar to patients whose prescriber did not respond for the main study outcomes: age (56.8 +/- 16.3 years vs. 56.1 +/- 16.3 years), sex (66.0% female vs. 64.8%), cardiovascular disease history (52.2% vs. 52.0%), gastrointestinal disease history (39.5% vs. 39.4%), concomitant prescription of gastroprotective agents (22.4% vs. 23.7%), and NSAID indication, prescription type, use, and duration.
We found no evidence for a difference between patients whose prescriber responded and patients whose prescriber did not participate in the study.
在由开处方者选择患者的药物流行病学研究中，有人担心做出回应的开处方者的患者不一定是所有患者的无偏样本。然而，这一点通常无法进行探究。在CADEUS研究中，患者和开处方者是被独立联系的，这样无论开处方者是否做出回应，患者的数据都是可得的。我们的目的是比较开处方者做出或未做出回应的患者的特征。
CADEUS研究纳入了2003年9月至2004年8月期间接受COX-2抑制剂（塞来昔布、罗非昔布）或传统非甾体抗炎药治疗的患者。在1年期间，从法国国家医疗保险系统中受薪人员数据库中每月随机抽取已兑换的处方。患者和开处方者被独立询问。来自患者的数据和数据库的数据被用于比较开处方者做出回应的患者和未做出回应的患者。
在45217名患者中，26618名有开处方者的数据。对于主要研究结果，开处方者做出回应的患者与未做出回应的患者相似：年龄（56.8±16.3岁对56.1±16.3岁）、性别（女性66.0%对64.8%）、心血管疾病史（52.2%对52.0%）、胃肠道疾病史（39.5%对39.4%）、胃保护剂的联合处方（22.4%对23.7%），以及非甾体抗炎药的适应证、处方类型、使用情况和疗程。
我们没有发现证据表明开处方者做出回应的患者与未参与研究的开处方者的患者之间存在差异。
