Galimberti Federica, Olmastroni Elena, Casula Manuela, Merlo Ivan, Franchi Matteo, Catapano Alberico Luigi, Orlando Valentina, Menditto Enrica, Tragni Elena, Edu Re Drug Group On Behalf Of
IRCCS MultiMedica, Sesto S. Giovanni, Italy.
Epidemiology and Preventive Pharmacology Service (SEFAP), Department of Pharmacological and Biomolecular Sciences, University of Milan, Milan, Italy.
Front Pharmacol. 2022 Apr 25;13:832169. doi: 10.3389/fphar.2022.832169. eCollection 2022.
EDU.RE.DRUG study is a prospective, multicentre, open-label, parallel-arm, controlled, pragmatic trial directed to general practitioners (GPs) and their patients. The study data were retrieved from health-related administrative databases of four local health units (LHUs) of Lombardy and four LHUs in Campania. According to the LHUs, the GPs/patients were assigned to (A) intervention on both GPs (feedback reports about appropriate prescribing among their patients and online courses) and patients (flyers and posters on proper drug use), (B) intervention on GPs, (C) intervention on patients, and (D) no intervention (control arm). A set of appropriate prescribing indicators (potential drug-drug interactions [pDDIs], potential and unnecessary therapeutic duplicates [pTDs], and inappropriate prescriptions in the elderly [ERD-list]) were measured at baseline and after the intervention phase. The effectiveness of the intervention was evaluated estimating the absolute difference in percentages of selected indicators carrying out linear random-intercept mixed-effect models. A cohort of 3,586 GPs (2,567 in intervention groups and 1,019 in the control group) was evaluated. In Campania, the mean pre-intervention percentage of patients with at least one pDDI was always greater than 20% and always lower than 15% in Lombardy. The pre-post difference was quite heterogeneous among the LHUs, ranging from 1.9 to -1.4 percentage points. The mean pre-intervention percentage of patients with pTDs ranged from 0.59 to 2.1%, with slightly higher values characterizing Campania LHUs. The magnitude of the pre-post difference was very low, ranging from -0.11 to 0.20. In Campania, the mean pre-intervention percentage of patients with at least one ERD criterium was considerably higher than in Lombardy (approximately 30% in Lombardy and 50% in Campania). The pre-post difference was again quite heterogeneous. The results from the models accounting for GP geographical belonging suggested that none of the interventions resulted in a statistically significant effect, for all the three indicators considered. The proposed strategy was shown to be not effective in influencing the voluntary changes in GP prescription performance. However, the use of a set of explicit indicators proved to be useful in quantifying the inappropriateness. Further efforts are needed to find more efficient strategies and design more tailored interventions.
EDU.RE.DRUG研究是一项针对全科医生(GP)及其患者的前瞻性、多中心、开放标签、平行组、对照、实用性试验。研究数据取自伦巴第大区四个地方卫生单位(LHU)和坎帕尼亚大区四个LHU的健康相关行政数据库。根据这些LHU,将全科医生/患者分为(A)对全科医生(关于其患者适当处方的反馈报告和在线课程)和患者(关于正确用药的传单和海报)均进行干预,(B)对全科医生进行干预,(C)对患者进行干预,以及(D)不进行干预(对照组)。在基线和干预期后测量了一组适当处方指标(潜在药物相互作用 [pDDI]、潜在和不必要的治疗重复 [pTD] 以及老年人不适当处方 [ERD清单])。通过估计采用线性随机截距混合效应模型的选定指标百分比的绝对差异来评估干预的有效性。评估了一组3586名全科医生(干预组2567名,对照组1019名)。在坎帕尼亚,至少有一个pDDI的患者干预前平均百分比始终大于20%,而在伦巴第始终低于15%。LHU之间的前后差异差异很大,范围从1.9到 -1.4个百分点。有pTD的患者干预前平均百分比范围为0.59%至2.1%,坎帕尼亚LHU的数值略高。前后差异的幅度非常小,范围从 -0.11到0.20。在坎帕尼亚,至少有一项ERD标准的患者干预前平均百分比明显高于伦巴第(伦巴第约为30%,坎帕尼亚为50%)。前后差异再次差异很大。考虑全科医生地理归属的模型结果表明,对于所考虑的所有三个指标,没有一种干预产生统计学上的显著效果。所提出的策略被证明在影响全科医生处方行为的自愿改变方面无效。然而,使用一组明确的指标被证明有助于量化不适当性。需要进一步努力寻找更有效的策略并设计更有针对性的干预措施。