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

Content Provider	Springer Nature : BioMed Central
Author	Stingl, Julia Carolin Kaumanns, Katharina Luise Claus, Katrin Lehmann, Marie-Louise Kastenmüller, Kathrin Bleckwenn, Markus Hartmann, Gunther Steffens, Michael Wirtz, Dorothee Leuchs, Ann-Kristin Benda, Norbert Meier, Florian Schöffski, Oliver Holdenrieder, Stefan Coch, Christoph Weckbecker, Klaus
Abstract	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.
Related Links	https://bmcprimcare.biomedcentral.com/counter/pdf/10.1186/s12875-016-0447-6.pdf
Ending Page	8
Page Count	8
Starting Page	1
File Format	HTM / HTML
ISSN	27314553
DOI	10.1186/s12875-016-0447-6
Journal	BMC Primary Care
Issue Number	1
Volume Number	17
Language	English
Publisher	BioMed Central
Publisher Date	2016-04-26
Access Restriction	Open
Subject Keyword	General Practice Family Medicine Primary Care Medicine Individualized medicine Adverse drug reaction Elderly Pharmacogenetics Polymedication Drug interaction ADR risk assessment Clinical decision support system
Content Type	Text
Resource Type	Article
Subject	Family Practice
Journal Impact Factor	3.2/2023
5-Year Journal Impact Factor	3.3/2023

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

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

Individualized versus Standardized Risk Assessment in Patients at High Risk for Adverse Drug Reactions (The IDrug Randomized Controlled Trial)–Never Change a Running System?

Standardized warfarin monitoring decreases adverse drug reactions

Recruitment and reach in a pragmatic behavioral weight loss randomized controlled trial: implications for real-world primary care practice

Improving chronic disease prevention and screening in primary care: results of the BETTER pragmatic cluster randomized controlled trial

Group-delivered cognitive behavioural therapy versus waiting list in the treatment of insomnia in primary care: study protocol for a pragmatic, multicentre randomized controlled trial

A pragmatic randomized trial of a primary care antimicrobial stewardship intervention in Ontario, Canada

Effects of a lifestyle program in subjects with Impaired Fasting Glucose, a pragmatic cluster-randomized controlled trial

Absolute cardiovascular disease risk and shared decision making in primary care: a randomized controlled trial.

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

Similar Documents

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

Individualized versus Standardized Risk Assessment in Patients at High Risk for Adverse Drug Reactions (The IDrug Randomized Controlled Trial)–Never Change a Running System?

Standardized warfarin monitoring decreases adverse drug reactions

Recruitment and reach in a pragmatic behavioral weight loss randomized controlled trial: implications for real-world primary care practice

Improving chronic disease prevention and screening in primary care: results of the BETTER pragmatic cluster randomized controlled trial

Group-delivered cognitive behavioural therapy versus waiting list in the treatment of insomnia in primary care: study protocol for a pragmatic, multicentre randomized controlled trial

A pragmatic randomized trial of a primary care antimicrobial stewardship intervention in Ontario, Canada

Effects of a lifestyle program in subjects with Impaired Fasting Glucose, a pragmatic cluster-randomized controlled trial

Absolute cardiovascular disease risk and shared decision making in primary care: a randomized controlled trial.

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