Wallerstedt Susanna M, Brunlöf Gertrud, Johansson Marie-Louise, Tukukino Carina, Ny Lars
Department of Clinical Pharmacology and Regional Pharmacovigilance Centre, Sahlgrenska University Hospital, SE-413 45, Göteborg, Sweden.
Eur J Clin Pharmacol. 2007 May;63(5):505-8. doi: 10.1007/s00228-007-0270-z. Epub 2007 Mar 9.
The purpose of this study was to investigate two different feedback alternatives to doctors reporting adverse drug reactions (ADRs) concerning (1) effects on reporting rates and (2) doctors' opinions.
When reporting an ADR during January through March 2006, doctors in the western part of Sweden were randomised according to working address to receive feedback I or feedback II. Feedback I consisted of the conventional mode of feedback. Feedback II consisted of the contents of feedback I supplemented with information on the reported drug from the regional drug information centre. A questionnaire was administered 2 weeks after the feedback. The doctors were asked to give their opinion on the feedback concerning amount of information, quality and overall impression on a 6-point scale, where 1 corresponded to too little/very bad and 6 to too much/very good. During the inclusion period and the 6-month follow-up period, additional ADR reports originating from receivers of either feedback I or II were identified and compared.
Sixty-six doctors received feedback I, and 49 received feedback II. The number of doctors reporting more than once was greater in the group receiving feedback II (39% vs. 22%; P = 0.039). Feedback II was judged to contain more information than feedback I (4.1 +/- 0.8 vs. 3.6 +/- 0.9; P = 0.014). No difference between the feedback alternatives concerning doctors' opinions on quality and overall impression could be detected. Sixty-five doctors (70%) stated that the content of the feedback letter could affect their willingness to report ADRs.
The content of the feedback to doctors reporting ADRs may influence reporting rates.
本研究旨在调查针对医生报告药品不良反应（ADR）的两种不同反馈方式，涉及（1）对报告率的影响，以及（2）医生的看法。
2006年1月至3月期间，瑞典西部的医生在报告ADR时，根据工作地址被随机分配接受反馈I或反馈II。反馈I采用传统的反馈方式。反馈II在反馈I的内容基础上，补充了来自地区药品信息中心的所报告药品的信息。在反馈两周后进行问卷调查。要求医生就反馈的信息量、质量和总体印象在6分制量表上给出意见，1分对应信息太少/非常差，6分对应信息太多/非常好。在纳入期和6个月的随访期内，识别并比较来自反馈I或反馈II接收者的额外ADR报告。
66名医生接受了反馈I，49名医生接受了反馈II。接受反馈II的组中多次报告的医生数量更多（39%对22%；P = 0.039）。反馈II被认为比反馈I包含更多信息（4.1±0.8对3.6±0.9；P = 0.014）。在医生对质量和总体印象的看法方面，两种反馈方式之间未发现差异。65名医生（70%）表示反馈信的内容会影响他们报告ADR的意愿。
向报告ADR的医生提供的反馈内容可能会影响报告率。
