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首页> 外文期刊>BMC Family Practice >Individualized versus standardized risk assessment in patients at high risk for adverse drug reactions (IDrug) – study protocol for a pragmatic randomized controlled trial
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Individualized versus standardized risk assessment in patients at high risk for adverse drug reactions (IDrug) – study protocol for a pragmatic randomized controlled trial

机译：药物不良反应高风险患者的个体化与标准风险评估（IDrug）–实用的随机对照试验研究方案

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Background Elderly patients are particularly vulnerable to adverse drug reactions, especially if they are affected by additional risk factors such as multimorbidity, polypharmacy, impaired renal function and intake of drugs with high risk potential. Apart from these clinical parameters, drug safety and efficacy can be influenced by pharmacogenetic factors. Evidence-based recommendations concerning drug-gene-combinations have been issued by international consortia and in drug labels. However, clinical benefit of providing information on individual patient factors in a comprehensive risk assessment aiming to reduce the occurrence and severity of adverse drug reactions is not evident. Purpose of this randomized controlled trial is to compare the effect of a concise individual risk information leaflet with standard information on risk factors for side effects. Methods/Design The trial was designed as a prospective, two-arm, randomized, controlled, multicenter, pragmatic study. 960 elderly, multimorbid outpatients in general medicine are included if they take at least one high risk and one other long-term drug (polymedication). As high risk “index drugs” oral anticoagulants and antiplatelets were chosen because of their specific, objectively assessable side effects. Following randomization, test group patients receive an individualized risk assessment leaflet evaluating their personal data concerning bleeding- and thromboembolic-risk-scores, potential drug-drug-interactions, age, renal function and pharmacogenetic factors. Control group patients obtain a standardized leaflet only containing general information on these criteria. Follow-up period is 9?months for each patient. Primary endpoint is the occurrence of a thromboembolic/bleeding event or death. Secondary endpoints are other adverse drug reactions, hospital admissions, specialist referrals and medication changes due to adverse drug reactions, the patients’ adherence to medication regimen as well as health related quality of life, mortality and resulting costs. Discussion Despite extensive evidence of risk factors for adverse drug reactions, there are few prospective trial data about an individualized risk assessment including pharmacogenetic information to increase patient safety. By conducting a health economic analysis, we will evaluate if the application of an individualized drug therapy in daily routine is cost-effective. Trial registration German Clinical Trials Register: DRKS00006256 , date of registration 09/01/15.
机译：背景技术老年患者特别容易受到药物不良反应的影响，特别是如果他们受到其他风险因素的影响，例如多发病，多药房，肾功能受损和高风险药物的摄入。除这些临床参数外，药物安全性和功效可能会受到药物遗传因素的影响。国际财团和药品标签已经发布了有关毒品基因组合的循证建议。但是，在旨在减少药物不良反应的发生和严重程度的全面风险评估中提供有关各个患者因素的信息的临床益处尚不明显。这项随机对照试验的目的是比较简明的个人风险信息单张与有关副作用风险因素的标准信息的效果。方法/设计该试验被设计为一项前瞻性，两臂，随机，对照，多中心，务实的研究。如果他们服用至少一种高风险药物和另一种长期药物（多药治疗），则包括960名老年，多病的普通科门诊患者。选择口服抗凝药和抗血小板药是高风险的“索引药”，因为它们具有特异性，可客观评估的副作用。随机分组后，测试组患者将收到一份个性化的风险评估单张，评估其有关出血和血栓栓塞风险评分，潜在药物相互作用，年龄，肾功能和药物遗传学因素的个人数据。对照组患者仅获得标准传单，其中仅包含有关这些标准的一般信息。每位患者的随访时间为9个月。主要终点是血栓栓塞/出血事件或死亡的发生。次要终点是其他药物不良反应，住院，专家转诊和药物不良反应引起的药物变化，患者对药物治疗的依从性以及与健康相关的生活质量，死亡率和由此产生的费用。讨论尽管有大量证据表明药物不良反应的危险因素，但很少有关于个体化风险评估的前瞻性试验数据，包括药物遗传学信息以提高患者安全性。通过进行卫生经济分析，我们将评估个性化药物治疗在日常中的应用是否具有成本效益。试验注册德国临床试验注册：DRKS00006256，注册日期为09/01/15。

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