Perceived adverse drug events in heart failure: patients' perception and related factors.
BACKGROUND
Patients with heart failure (HF) often perceive adverse drug events (ADEs), affecting quality of life. For weighing the benefits and burden of medication in HF care, knowledge on patients' perception of ADEs is needed. Our aim was to assess these ADE perceptions and to identify factors related to these perceptions.


METHODS
A cross-sectional study was performed including HF patients recruited from primary care and outpatient clinics. Patients were included in the analysis if they perceived an ADE in the past 4 weeks. This information was collected using an open-ended question and a symptom checklist. Data on ADE perception were obtained using a modified version of the Revised Illness Perception Questionnaire. Demographic, clinical, and ADE characteristics were collected by self-administered questionnaire and chart review. The relations between these factors and ADE perceptions were analyzed using regression analyses.


RESULTS
In total, 261 HF patients perceived an ADE and completed the questionnaire. Patients reported 814 ADEs, of which 26% of the patients reported dizziness and 24% reported dry mouth as being the most prevalent. Almost half of the patients (46%) perceived their ADE as something serious, with major consequences for their daily life (40%) and reported to be worried (36%) about the ADE. Patients perceived the ADE as a chronic problem (91%), and the majority believed more in the ability of the health care provider to control the ADE (61%) than in their own ability (46%). Demographic and clinical variables had a limited contribution to the explained variance of ADE perceptions after adjusting for ADE characteristics, such as perceived severity.


CONCLUSIONS
Patients with HF perceive particular negative consequences and emotional distress of symptomatic ADE. Open communication between patients and providers with attention for patients ADE perceptions would be valuable during the decision process of ADE management and may result in a regimen aligned with patients' preferences and needs.
Department of Clinical Pharmacology, University of Medical Center Groningen, Graduate School for Health Research Share, University of Groningen, the Netherlands. r.h.e.de.smedt@med.umcg.nl
Ruth H E
RH
De Smedt
Flora M
FM
Haaijer-Ruskamp
Klaas H
KH
Groenier
Klaas
K
van der Meer
Tiny
T
Jaarsma
D000223:Adaptation, Psychological; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001294:Attitude to Health; D002317:Cardiovascular Agents / Q000009:adverse effects*; D003430:Cross-Sectional Studies; D005260:Female; D006333:Heart Failure / Q000188:drug therapy*; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D009426:Netherlands; D010817:Physician-Patient Relations; D011788:Quality of Life; D012044:Regression Analysis
D002317:Cardiovascular Agents