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Are Anticholinergic Symptoms a Risk Factor for Falls in Older General Practice Patients With Polypharmacy? Study Protocol for the Development and Validation of a Prognostic Model

Background: Cumulative anticholinergic exposure, also known as anticholinergic burden, is associated with a variety of adverse outcomes. However, studies show that anticholinergic effects tend to be underestimated by prescribers, and anticholinergics are the most frequently prescribed potentially in...

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Autores principales: Dinh, Truc Sophia, González-González, Ana Isabel, Meid, Andreas D., Snell, Kym I. E., Rudolf, Henrik, Brueckle, Maria-Sophie, Blom, Jeanet W., Thiem, Ulrich, Trampisch, Hans-Joachim, Elders, Petra J. M., Donner-Banzhoff, Norbert, Gerlach, Ferdinand M., Harder, Sebastian, van den Akker, Marjan, Glasziou, Paul P., Haefeli, Walter E., Muth, Christiane
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7845421/
https://www.ncbi.nlm.nih.gov/pubmed/33519441
http://dx.doi.org/10.3389/fphar.2020.577747
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author Dinh, Truc Sophia
González-González, Ana Isabel
Meid, Andreas D.
Snell, Kym I. E.
Rudolf, Henrik
Brueckle, Maria-Sophie
Blom, Jeanet W.
Thiem, Ulrich
Trampisch, Hans-Joachim
Elders, Petra J. M.
Donner-Banzhoff, Norbert
Gerlach, Ferdinand M.
Harder, Sebastian
van den Akker, Marjan
Glasziou, Paul P.
Haefeli, Walter E.
Muth, Christiane
author_facet Dinh, Truc Sophia
González-González, Ana Isabel
Meid, Andreas D.
Snell, Kym I. E.
Rudolf, Henrik
Brueckle, Maria-Sophie
Blom, Jeanet W.
Thiem, Ulrich
Trampisch, Hans-Joachim
Elders, Petra J. M.
Donner-Banzhoff, Norbert
Gerlach, Ferdinand M.
Harder, Sebastian
van den Akker, Marjan
Glasziou, Paul P.
Haefeli, Walter E.
Muth, Christiane
author_sort Dinh, Truc Sophia
collection PubMed
description Background: Cumulative anticholinergic exposure, also known as anticholinergic burden, is associated with a variety of adverse outcomes. However, studies show that anticholinergic effects tend to be underestimated by prescribers, and anticholinergics are the most frequently prescribed potentially inappropriate medication in older patients. The grading systems and drugs included in existing scales to quantify anticholinergic burden differ considerably and do not adequately account for patients’ susceptibility to medications. Furthermore, their ability to link anticholinergic burden with adverse outcomes such as falls is unclear. This study aims to develop a prognostic model that predicts falls in older general practice patients, to assess the performance of several anticholinergic burden scales, and to quantify the added predictive value of anticholinergic symptoms in this context. Methods: Data from two cluster-randomized controlled trials investigating medication optimization in older general practice patients in Germany will be used. One trial (RIME, n = 1,197) will be used for the model development and the other trial (PRIMUM, n = 502) will be used to externally validate the model. A priori, candidate predictors will be selected based on a literature search, predictor availability, and clinical reasoning. Candidate predictors will include socio-demographics (e.g. age, sex), morbidity (e.g. single conditions), medication (e.g. polypharmacy, anticholinergic burden as defined by scales), and well-being (e.g. quality of life, physical function). A prognostic model including sociodemographic and lifestyle-related factors, as well as variables on morbidity, medication, health status, and well-being, will be developed, whereby the prognostic value of extending the model to include additional patient-reported symptoms will be also assessed. Logistic regression will be used for the binary outcome, which will be defined as “no falls” vs. “≥1 fall” within six months of baseline, as reported in patient interviews. Discussion: As the ability of different anticholinergic burden scales to predict falls in older patients is unclear, this study may provide insights into their relative importance as well as into the overall contribution of anticholinergic symptoms and other patient characteristics. The results may support general practitioners in their clinical decision-making and in prescribing fewer medications with anticholinergic properties.
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spelling pubmed-78454212021-01-30 Are Anticholinergic Symptoms a Risk Factor for Falls in Older General Practice Patients With Polypharmacy? Study Protocol for the Development and Validation of a Prognostic Model Dinh, Truc Sophia González-González, Ana Isabel Meid, Andreas D. Snell, Kym I. E. Rudolf, Henrik Brueckle, Maria-Sophie Blom, Jeanet W. Thiem, Ulrich Trampisch, Hans-Joachim Elders, Petra J. M. Donner-Banzhoff, Norbert Gerlach, Ferdinand M. Harder, Sebastian van den Akker, Marjan Glasziou, Paul P. Haefeli, Walter E. Muth, Christiane Front Pharmacol Pharmacology Background: Cumulative anticholinergic exposure, also known as anticholinergic burden, is associated with a variety of adverse outcomes. However, studies show that anticholinergic effects tend to be underestimated by prescribers, and anticholinergics are the most frequently prescribed potentially inappropriate medication in older patients. The grading systems and drugs included in existing scales to quantify anticholinergic burden differ considerably and do not adequately account for patients’ susceptibility to medications. Furthermore, their ability to link anticholinergic burden with adverse outcomes such as falls is unclear. This study aims to develop a prognostic model that predicts falls in older general practice patients, to assess the performance of several anticholinergic burden scales, and to quantify the added predictive value of anticholinergic symptoms in this context. Methods: Data from two cluster-randomized controlled trials investigating medication optimization in older general practice patients in Germany will be used. One trial (RIME, n = 1,197) will be used for the model development and the other trial (PRIMUM, n = 502) will be used to externally validate the model. A priori, candidate predictors will be selected based on a literature search, predictor availability, and clinical reasoning. Candidate predictors will include socio-demographics (e.g. age, sex), morbidity (e.g. single conditions), medication (e.g. polypharmacy, anticholinergic burden as defined by scales), and well-being (e.g. quality of life, physical function). A prognostic model including sociodemographic and lifestyle-related factors, as well as variables on morbidity, medication, health status, and well-being, will be developed, whereby the prognostic value of extending the model to include additional patient-reported symptoms will be also assessed. Logistic regression will be used for the binary outcome, which will be defined as “no falls” vs. “≥1 fall” within six months of baseline, as reported in patient interviews. Discussion: As the ability of different anticholinergic burden scales to predict falls in older patients is unclear, this study may provide insights into their relative importance as well as into the overall contribution of anticholinergic symptoms and other patient characteristics. The results may support general practitioners in their clinical decision-making and in prescribing fewer medications with anticholinergic properties. Frontiers Media S.A. 2021-01-14 /pmc/articles/PMC7845421/ /pubmed/33519441 http://dx.doi.org/10.3389/fphar.2020.577747 Text en Copyright © 2021 Dinh, González-González, Meid, Snell, Rudolf, Brueckle, Blom, Thiem, Trampisch, Elders, Donner-Banzhoff, Gerlach, Harder, van den Akker, Glasziou, Haefeli and Muth. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) (http://creativecommons.org/licenses/by/4.0/) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pharmacology
Dinh, Truc Sophia
González-González, Ana Isabel
Meid, Andreas D.
Snell, Kym I. E.
Rudolf, Henrik
Brueckle, Maria-Sophie
Blom, Jeanet W.
Thiem, Ulrich
Trampisch, Hans-Joachim
Elders, Petra J. M.
Donner-Banzhoff, Norbert
Gerlach, Ferdinand M.
Harder, Sebastian
van den Akker, Marjan
Glasziou, Paul P.
Haefeli, Walter E.
Muth, Christiane
Are Anticholinergic Symptoms a Risk Factor for Falls in Older General Practice Patients With Polypharmacy? Study Protocol for the Development and Validation of a Prognostic Model
title Are Anticholinergic Symptoms a Risk Factor for Falls in Older General Practice Patients With Polypharmacy? Study Protocol for the Development and Validation of a Prognostic Model
title_full Are Anticholinergic Symptoms a Risk Factor for Falls in Older General Practice Patients With Polypharmacy? Study Protocol for the Development and Validation of a Prognostic Model
title_fullStr Are Anticholinergic Symptoms a Risk Factor for Falls in Older General Practice Patients With Polypharmacy? Study Protocol for the Development and Validation of a Prognostic Model
title_full_unstemmed Are Anticholinergic Symptoms a Risk Factor for Falls in Older General Practice Patients With Polypharmacy? Study Protocol for the Development and Validation of a Prognostic Model
title_short Are Anticholinergic Symptoms a Risk Factor for Falls in Older General Practice Patients With Polypharmacy? Study Protocol for the Development and Validation of a Prognostic Model
title_sort are anticholinergic symptoms a risk factor for falls in older general practice patients with polypharmacy? study protocol for the development and validation of a prognostic model
topic Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7845421/
https://www.ncbi.nlm.nih.gov/pubmed/33519441
http://dx.doi.org/10.3389/fphar.2020.577747
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