Individualized versus standardized risk assessment in patients at high risk for adverse drug reactions (IDrug) – study protocol for a pragmatic randomized controlled trial

BMC Family Practice

Study Protocol

Florian Meier¹  Oliver Schöffski²  Gunther Hartmann³  Stefan Holdenrieder³  Christoph Coch³  Kathrin Kastenmüller⁴  Klaus Weckbecker⁴  Markus Bleckwenn⁴  Dorothee Wirtz⁵  Ann-Kristin Leuchs⁵  Norbert Benda⁵  Julia Carolin Stingl⁶  Katharina Luise Kaumanns⁶  Michael Steffens⁶  Katrin Claus⁶  Marie-Louise Lehmann⁶ 

[1] Department of Economics and Management, Wilhelm Löhe University of Applied Sciences, Merkurstraße 41, 90763, Fürth, Germany;Department of Health Management, University of Erlangen-Nürnberg, Lange Gasse 20, 90403, Nürnberg, Germany;Institute of Clinical Chemistry and Clinical Pharmacology, University of Bonn, Sigmund-Freud-Str. 25, 53127, Bonn, Germany;Institute of General Practice and Family Medicine, University of Bonn, Sigmund-Freud-Str. 25, 53127, Bonn, Germany;Research Division, Federal Institute for Drugs and Medical Devices, Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Germany;Research Division, Federal Institute for Drugs and Medical Devices, Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Germany;Centre for Translational Medicine, University of Bonn, Sigmund-Freud-Str. 25, 53127, Bonn, Germany;

关键词: Individualized medicine;    Adverse drug reaction;    Elderly;    Pharmacogenetics;    Polymedication;    Drug interaction;    ADR risk assessment;    Clinical decision support system;   

DOI  :  10.1186/s12875-016-0447-6

 received in 2016-03-29, accepted in 2016-04-14,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundElderly 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/DesignThe 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.DiscussionDespite 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 registrationGerman Clinical Trials Register: DRKS00006256, date of registration 09/01/15.

【 授权许可】

CC BY   
© Stingl et al. 2016