Decision-making, emotional distress, and quality of life in patients affected by the recall of their implantable cardioverter defibrillator.
Europace
; 10(5): 540-4, 2008 May.
Article
em En
| MEDLINE
| ID: mdl-18442964
ABSTRACT
AIMS:
We sought to investigate whether patients with implantable cardioverter defibrillators (ICDs) were suffering from emotional distress related to the recent United States Food and Drug Administration (FDA) recalls, to better understand their decision process related to device replacement, and to assess any impact of recall on quality of life (QOL). METHODS ANDRESULTS:
Thirty-one patients experiencing device recalls answered questions regarding their knowledge about the recall and their decision whether to replace the device. Fifty patients whose devices were not recalled reported demographic data. In both groups, psychological factors were assessed. No significant differences were found for psychological factors. Most patients reported being informed of their recall by their physician. Most estimated the risk of device failure to be low or very low, but they overestimated the fail rate. Thirty-six per cent of patients reported feeling anxious about the recall.CONCLUSION:
No significant differences existed in psychological factors and QOL between patients whose ICDs were recalled compared with those whose devices were not. The majority of patients whose ICDs are the subject of an FDA advisory/recall have a realistic understanding of the risks of device failure. Prompt information, support, and reassurance provided by healthcare professionals may allay patient distress.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Vigilância de Produtos Comercializados
/
Qualidade de Vida
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Estresse Psicológico
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Atitude Frente a Saúde
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Aceitação pelo Paciente de Cuidados de Saúde
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Desfibriladores Implantáveis
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Tomada de Decisões
Idioma:
En
Ano de publicação:
2008
Tipo de documento:
Article