Abstract
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.
Highlights
Medications with anticholinergic (ACh) properties are commonly used for a variety of indications (Jessen et al, 2010; Wawruch et al, 2012; Mate et al, 2015) and, along with sedatives, are the most frequently prescribed potentially inappropriate medications (PIM) in older adults (Hukins et al, 2019)
Patients’ individual characteristics and patient-reported symptoms may reflect clinically relevant and feasible indicators to identify patients from a heterogeneous population that might be at high risk of experiencing falls
As one of the limitations of ACh scales’ is their failure to take into account individual patient characteristics, patient-reported symptoms may function as a surrogate for patient susceptibility to such medications and may help clinicians identify patients at high risk of falls
Summary
Medications with anticholinergic (ACh) properties are commonly used for a variety of indications (Jessen et al, 2010; Wawruch et al, 2012; Mate et al, 2015) and, along with sedatives, are the most frequently prescribed potentially inappropriate medications (PIM) in older adults (Hukins et al, 2019). The high volume of ACh drug prescriptions raises concerns in terms of appropriateness and patient safety This is especially true in older age, as it is associated with an increased likelihood of multiple chronic conditions (multimorbidity) and subsequent long-term medication use (polypharmacy), which may further lead to an accumulation of effects and result in substantial harm (Thomas and Brennan 2000; Hilmer et al, 2007a; Delafuente, 2008; Gnjidic et al, 2012; Kouladjian O’Donnell et al, 2017). 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 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.
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