| Medicine has succeeded in the research and development of extraordinary implantable cardiac biomedical devices that provide targeted therapies for cardiac arrhythmias. However, a theoretical framework and common metric for studying the quality of life and psychosocial adjustment of these patients has not been empirically investigated. The purposes of our study were (a) to develop an instrument to measure patient acceptance of implantable devices; (b) to begin validation of the instrument; and (c) to compare, using the developed and validated measure, acceptance and quality of life in patients with pacemakers, implantable cardioverter defibrillators (ICD), or implantable atrioverter defibrillators (IAD).; We constructed 47 items of patient acceptance. Through statistical analyses we reduced these to 15 essential items. By using exploratory factor analysis, we extracted four factors: Return to Life (RTL), Device-Related Distress (DRD), Positive Appraisal (PA), and Body Image Concerns (BIC). The four factors were internally consistent, and a reliable higher-order factor also was found. The validity of the measure was addressed using a battery of instruments that assessed each component of the biopsychosocial model of illness. In between-group comparisons, the patient acceptance measure revealed that, overall, device acceptance was significantly greater for pacemaker patients then for ICD patients. Device-related distress was lower for pacemaker patients than for either ICD or IAD patients. Concerns about returning to their former lives are fewer for pacemaker and IAD patients than for ICD patients. The patient acceptance measure is the first empirically investigated device-specific instrument to provide a common metric used to study this unique group of patients. The information obtained has important implications for the development and implementation of psychosocial interventions that address the distress associated with the implantation of a cardiac device. |
