Magrini Nicola, Formoso Giulio, Capelli Oreste, Maestri Emilio, Nonino Francesco, Paltrinieri Barbara, Del Giovane Cinzia, Voci Claudio, Magnano Lucia, Daya Lisa, Marata Anna Maria
Drug Evaluation Area, Emilia-Romagna Regional Agency for Health and Social Care, Bologna, Italy.
Local Health Authority, Modena, Italy.
PLoS One. 2014 Oct 17;9(10):e109915. doi: 10.1371/journal.pone.0109915. eCollection 2014.
Information on benefits and risks of drugs is a key element affecting doctors' prescribing decisions. Outreach visits promoting independent information have proved moderately effective in changing prescribing behaviours.
Testing the short and long-term effectiveness on general practitioners' prescribing of small groups meetings led by pharmacists.
Two cluster open randomised controlled trials (RCTs) were carried out in a large scale NHS setting. Ad hoc prepared evidence based material were used considering a therapeutic area approach--TEA, with information materials on osteoporosis or prostatic hyperplasia--and a single drug oriented approach--SIDRO, with information materials on me-too drugs of 2 different classes: barnidipine or prulifloxacin. In each study, all 115 Primary Care Groups in a Northern Italy area (2.2 million inhabitants, 1737 general practitioners) were randomised to educational small groups meetings, in which available evidence was provided together with drug utilization data and clinical scenarios. Main outcomes were changes in the six-months prescription of targeted drugs. Longer term results (24 and 48 months) were also evaluated.
In the TEA trial, one of the four primary outcomes showed a reduction (prescription of alfuzosin compared to tamsulosin and terazosin in benign prostatic hyperplasia: prescribing ratio -8.5%, p = 0.03). Another primary outcome (prescription of risedronate) showed a reduction at 24 and 48 months (-7.6%, p = 0.02; and -9,8%, p = 0.03), but not at six months (-5.1%, p = 0.36). In the SIDRO trial both primary outcomes showed a statistically significant reduction (prescription of barnidipine -9.8%, p = 0.02; prescription of prulifloxacin -11.1%, p = 0.04), which persisted or increased over time.
These two cluster RCTs showed the large scale feasibility of a complex educational program in a NHS setting, and its potentially relevant long-term impact on prescribing habits, in particular when focusing on a single drug. National Health systems should invest in independent drug information programs.
Controlled-Trials.com ISRCTN05866587.
药物的益处和风险信息是影响医生处方决策的关键因素。推广独立信息的外展访问已被证明在改变处方行为方面有一定效果。
测试由药剂师主持的小组会议对全科医生处方的短期和长期效果。
在大规模的英国国家医疗服务体系（NHS）环境中进行了两项整群开放随机对照试验（RCT）。考虑到治疗领域方法（TEA），即使用关于骨质疏松症或前列腺增生的信息材料，以及单一药物导向方法（SIDRO），即使用关于两类不同的仿制药（巴尼地平或普卢利沙星）的信息材料，使用了临时准备的循证材料。在每项研究中，意大利北部地区的所有115个初级保健组（220万居民，1737名全科医生）被随机分配到教育小组会议，在会议上提供现有证据以及药物使用数据和临床案例。主要结果是目标药物六个月处方量的变化。还评估了长期结果（24个月和48个月）。
在TEA试验中，四个主要结果之一显示出减少（在良性前列腺增生中，与坦索罗辛和特拉唑嗪相比，阿夫唑嗪的处方量：处方率 -8.5%，p = 0.03）。另一个主要结果（利塞膦酸盐的处方量）在24个月和48个月时显示出减少（-7.6%，p = 0.02；和 -9.8%，p = 0.03），但在六个月时没有减少（-5.1%，p = 0.36）。在SIDRO试验中，两个主要结果均显示出统计学上的显著减少（巴尼地平的处方量 -9.8%，p = 0.02；普卢利沙星的处方量 -11.1%，p = 0.04），并且这种减少随着时间持续或增加。
这两项整群随机对照试验表明，在NHS环境中开展复杂教育项目具有大规模可行性，并且对处方习惯有潜在的长期影响，特别是在聚焦单一药物时。国家卫生系统应投资于独立的药物信息项目。
Controlled-Trials.com ISRCTN05866587
