PMID- 33410972
OWN - NLM
STAT- MEDLINE
DCOM- 20211115
LR  - 20211115
IS  - 1432-1041 (Electronic)
IS  - 0031-6970 (Linking)
VI  - 77
IP  - 6
DP  - 2021 Jun
TI  - Older participant perspectives on permanent study drug discontinuation in an 
      ongoing primary prevention trial of statins.
PG  - 841-847
LID - 10.1007/s00228-020-03073-x [doi]
AB  - PURPOSE: Study drug discontinuation is commonplace in clinical trials of older 
      populations. Little is known about why older participants discontinue the study 
      drug. This qualitative study aimed to understand factors contributing to 
      permanent study drug discontinuation among participants aged >/= 70 years within an 
      ongoing primary prevention trial of statins by exploring their experiences and 
      perceptions. METHODS: Trial participants who had permanently discontinued the 
      study drug within 2 years of randomisation were purposively sampled by age (< 75 
      and >/= 75 years) and sex to participate in semi-structured phone interviews 
      between March 2019 and February 2020. Interviews were audio-recorded, transcribed 
      and analysed thematically. RESULTS: Thirty participants were interviewed (21 
      females; mean age, 77 years), and three themes were identified from the data. 
      Perceived adverse events (AEs) and their effect on daily living (mobility, 
      functional capacity, quality of life) were identified as the major factors 
      leading to the participants permanently discontinuing their study drug, despite 
      an ambiguity about the cause of the AE. For some, concurrent challenging life 
      circumstances further lowered their tolerance to perceived AEs thus making 
      discontinuation more likely. A few discontinuations were attributed to other 
      factors (e.g. GP advice, unrelated illness). CONCLUSION: Among healthy older 
      participants enrolled in a statin trial, perceived AEs and their related impact 
      were key factors contributing to the permanent study drug discontinuation. 
      Addressing anticipated participant-reported AEs and their concerns about 
      drug-related side effects at trial entry, as well as offering timely medical 
      assistance and support when AEs occur, may be useful to reduce drug 
      discontinuation rates.
FAU - Zhou, Zhen
AU  - Zhou Z
AUID- ORCID: 0000-0002-0835-8686
AD  - Menzies Institute for Medical Research, University of Tasmania, 17 Liverpool 
      Street, Hobart, TAS, 7000, Australia. zhen.zhou@utas.edu.au.
FAU - Jose, Kim
AU  - Jose K
AD  - Menzies Institute for Medical Research, University of Tasmania, 17 Liverpool 
      Street, Hobart, TAS, 7000, Australia.
FAU - Curtis, Andrea J
AU  - Curtis AJ
AD  - Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, 
      Australia.
FAU - Kost, Alissia
AU  - Kost A
AD  - Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, 
      Australia.
FAU - Breslin, Monique
AU  - Breslin M
AD  - Menzies Institute for Medical Research, University of Tasmania, 17 Liverpool 
      Street, Hobart, TAS, 7000, Australia.
FAU - Zoungas, Sophia
AU  - Zoungas S
AD  - Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, 
      Australia.
FAU - Nelson, Mark R
AU  - Nelson MR
AD  - Menzies Institute for Medical Research, University of Tasmania, 17 Liverpool 
      Street, Hobart, TAS, 7000, Australia.
CN  - STAREE Investigator Group
LA  - eng
PT  - Journal Article
DEP - 20210107
PL  - Germany
TA  - Eur J Clin Pharmacol
JT  - European journal of clinical pharmacology
JID - 1256165
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
SB  - IM
MH  - Age Factors
MH  - Aged
MH  - Aged, 80 and over
MH  - Female
MH  - Healthy Volunteers/*psychology
MH  - Humans
MH  - Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Interviews as Topic
MH  - Male
MH  - Medication Adherence/*psychology
MH  - Mobility Limitation
MH  - Primary Prevention/*methods
MH  - Qualitative Research
MH  - Quality of Life
MH  - Randomized Controlled Trials as Topic
MH  - Sex Factors
OTO - NOTNLM
OT  - Aged
OT  - Clinical trial
OT  - Medication adherence
OT  - Qualitative research
EDAT- 2021/01/08 06:00
MHDA- 2021/11/16 06:00
CRDT- 2021/01/07 12:16
PHST- 2020/09/02 00:00 [received]
PHST- 2020/12/15 00:00 [accepted]
PHST- 2021/01/08 06:00 [pubmed]
PHST- 2021/11/16 06:00 [medline]
PHST- 2021/01/07 12:16 [entrez]
AID - 10.1007/s00228-020-03073-x [pii]
AID - 10.1007/s00228-020-03073-x [doi]
PST - ppublish
SO  - Eur J Clin Pharmacol. 2021 Jun;77(6):841-847. doi: 10.1007/s00228-020-03073-x. 
      Epub 2021 Jan 7.