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 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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Author:Truc Sophia Dinh, Ana Isabel González-González, Andreas D. Meid, Kym I. E. SnellORCiD, Henrik Rudolf, Maria-Sophie BrückleGND, Jeanet W. Blom, Ulrich ThiemORCiDGND, Hans-Joachim Trampisch, Petra J. M. EldersORCiD, Norbert Donner-Banzhoff, Ferdinand M. GerlachORCiDGND, Sebastian HarderGND, Marjan van den AkkerORCiDGND, Paul P. Glasziou, Walter E. HaefeliORCiDGND, Christiane MuthORCiDGND
Parent Title (English):Frontiers in pharmacology
Publisher:Frontiers Media
Place of publication:Lausanne
Document Type:Article
Date of Publication (online):2021/01/14
Date of first Publication:2021/01/14
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Release Date:2021/01/29
Tag:accidental falls [MeSH]; aged [MesH]; anticholinergic burden; general practice; multimorbidity [MeSH]; polypharmacy; prediction model; prognosis research
Issue:Article 577747
Page Number:10
First Page:1
Last Page:10
PROPERmed was funded by the German Innovation Fund (grant number 01VSF16018). RIME was funded by the German Federal Ministry of Education and Research (grant number 01ET1005A). PRIMUM was funded by the German Federal Ministry of Education and Research (grant number 01GK0702). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Institutes:Medizin / Medizin
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Licence (German):License LogoCreative Commons - Namensnennung 4.0