The Feasibility of Using N-Of-1 Trials to Investigate Deprescribing in Older Adults with Dementia: A Pilot Study
1
Sydney Pharmacy School, Faculty of Medicine and Health, University of Sydney, Camperdown, NSW 2006, Australia
2
Kolling Institute of Medical Research, Royal North Shore Hospital and Northern Clinical School, Faculty of Medicine and Health, University of Sydney, St Leonards, NSW 2064, Australia
3
Charles Perkins Centre, University of Sydney, Camperdown, NSW 2006, Australia
*
Author to whom correspondence should be addressed.
Healthcare 2019, 7(4), 161; https://doi.org/10.3390/healthcare7040161
Received: 6 September 2019
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Revised: 5 November 2019
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Accepted: 9 December 2019
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Published: 12 December 2019
(This article belongs to the Special Issue N-of-1 Trials in Healthcare)
N-of-1 trials may provide insights into the impact of deprescribing medications in populations where evidence is currently lacking, such as the effect of statins on cognition in people with dementia. For this pilot, N-of-1, double-blinded, deprescribing trial, adults over 80 years of age with dementia taking statins for at least 6-months were recruited from a hospital’s geriatric medicine outpatient clinic in Sydney, Australia. Participants discontinued and restarted statins over the study period. At enrolment, the hospital pharmacy—using a random number generator, randomised recruited participants to their usual statin or placebo regimen, with assessment and switching of treatment every 5 weeks from baseline (0-weeks) until Visit 4 (15-weeks). Primary outcome was measured using the rate of change in Alzheimer’s Disease Assessment Score-Cognitive Subscale (ADAS-CoG). Over 6-months, 81 participants were screened, 14 were eligible, and four were randomised. One participant (female, 88 years) completed all four assessments with no major harms reported. Cognitive impairment, as measured by ADAS-CoG score, was similar on placebo (15.5/70) compared to statin (15/70). This study suggests there are significant challenges in performing N-of-1 trials and recruiting people with dementia into deprescribing trials from outpatient settings.
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Keywords:
N-of-1 trials; deprescribing; dementia; statins; feasibility study
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MDPI and ACS Style
Clough, A.J.; Hilmer, S.N.; Naismith, S.L.; Gnjidic, D. The Feasibility of Using N-Of-1 Trials to Investigate Deprescribing in Older Adults with Dementia: A Pilot Study. Healthcare 2019, 7, 161. https://doi.org/10.3390/healthcare7040161
AMA Style
Clough AJ, Hilmer SN, Naismith SL, Gnjidic D. The Feasibility of Using N-Of-1 Trials to Investigate Deprescribing in Older Adults with Dementia: A Pilot Study. Healthcare. 2019; 7(4):161. https://doi.org/10.3390/healthcare7040161
Chicago/Turabian StyleClough, Alexander J., Sarah N. Hilmer, Sharon L. Naismith, and Danijela Gnjidic. 2019. "The Feasibility of Using N-Of-1 Trials to Investigate Deprescribing in Older Adults with Dementia: A Pilot Study" Healthcare 7, no. 4: 161. https://doi.org/10.3390/healthcare7040161
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