Key Cheryl, Layton Deborah, Shakir Saad A W
Drug Safety Research Unit, Burseldon Hall, Southampton SO31 1AA, UK.
Pharmacoepidemiol Drug Saf. 2002 Mar;11(2):143-8. doi: 10.1002/pds.690.
A Prescription Event Monitoring (PEM) study was carried out by the Drug Safety Research Unit (DSRU) to monitor the safety of irbesartan, an angiotensin II antagonist, immediately after launch in the United Kingdom in September 1997. The DSRU 'green form' questionnaire response rate was lower than expected. The manufacturer was conducting a concurrent postmarketing surveillance study. The aim of this cross-sectional study, was to identify reasons for non-response by general practitioners in England.
In PEM, questionnaires are posted to the prescribing general practitioner approximately 6 months after the date of the first prescription for each patient, requesting details of clinical events recorded in the patients' notes since starting treatment. Those that failed to respond were sent a second questionnaire, including tick box questions to elucidate reasons for non-response.
A total of 21.3% (3088/14502) second send forms were returned. There were 1747 tick box responses. The most common reason specified for non-response was 'I was too busy' (31.2%) followed by 'no payment included' (13.4%). Participation in another study accounted for only 3.4%.
The concurrent postmarketing surveillance study was not a significant factor. The general practitioner's workload appeared to have a far larger impact. While research remains a non-core activity and receives no payment, participation is likely to fall. Researchers need to find means of benefiting the general practitioner if participation is to continue.
药物安全研究单位（DSRU）开展了一项处方事件监测（PEM）研究，以监测1997年9月在英国上市后不久的血管紧张素II拮抗剂厄贝沙坦的安全性。DSRU“绿色表格”问卷的回复率低于预期。制造商同时在进行一项上市后监测研究。这项横断面研究的目的是确定英格兰全科医生不回复的原因。
在PEM中，问卷会在为每位患者开出第一张处方约6个月后寄给开处方的全科医生，要求提供自开始治疗以来患者病历中记录的临床事件详细信息。对未回复的医生发送第二份问卷，其中包括勾选框问题以阐明不回复的原因。
共返回了21.3%（3088/14502）的第二次发送表格。有1747份勾选框回复。指定的最常见不回复原因是“我太忙了”（31.2%），其次是“未包含报酬”（13.4%）。参与另一项研究仅占3.4%。
同时进行的上市后监测研究不是一个重要因素。全科医生的工作量似乎影响要大得多。当研究仍然是非核心活动且没有报酬时，参与度可能会下降。如果要继续让全科医生参与，研究人员需要找到使全科医生受益的方法。
