Patient evaluation of ICD recall communication strategies: A vignette study

PACE - Pacing and Clinical Electrophysiology

Volumn 30, Issue 9, 2007, Pages 1105-1111

  Stutts, Lauren A ^a,c   Conti, Jamie B ^b   Aranda Jr , Juan M ^b   Miles, William M ^b   Burkart, Thomas A ^b   Sears, Samuel F ^a  

^a Clinical and Health Psychology   (United States)

^b UNIVERSITY OF FLORIDA HEALTH   (United States)

^c UNIVERSITY OF FLORIDA   (United States)

Author keywords

Anxiety; Implantable cardioverter defibrillator; Quality of life; Recall

Indexed keywords

ACCURACY; ADULT; AGED; ARTICLE; COMPARATIVE STUDY; CONFIDENTIALITY; DEFIBRILLATOR; DEVICE; EVALUATION; FEMALE; HUMAN; INFORMATION; INTERPERSONAL COMMUNICATION; LEARNING; MAJOR CLINICAL STUDY; MALE; PATIENT ASSESSMENT; PHYSICIAN; PHYSICIAN SELF-REFERRAL; RATING SCALE; RECALL; VIGNETTE;

ADULT; AGED; AGED, 80 AND OVER; COMMUNICATION; DEFIBRILLATORS, IMPLANTABLE; DISCLOSURE; EQUIPMENT FAILURE; EQUIPMENT FAILURE ANALYSIS; EQUIPMENT SAFETY; FEMALE; FLORIDA; HUMANS; MALE; MIDDLE AGED; PATIENT SATISFACTION; PRODUCT SURVEILLANCE, POSTMARKETING;

EID: 34548126894     PISSN: 01478389     EISSN: 15408159     Source Type: Journal    
DOI: 10.1111/j.1540-8159.2007.00820.x     Document Type: Article

References (17)

1. Maisel WH. Safety issues involving medical devices: Implications of recent implantable cardioverter-defibrillator malfunctions. JAMA 2005 294 : 955 958.
2. Myerburg RJ, Feigal DW, Jr., Lindsay BD. Life-threatening malfunction of implantable cardiac devices. N Engl J Med 2006 354 : 2309 2311.
3. Meier B. Papers show Guidant considered warning doctors of hazards. New York Times. June 7, 2006.
4. Moore J. Recalls have weakened defibrillator demand. Star Tribune. April 11, 2006.
5. Maisel WH, Moynahan M, Zuckerman BD, Gross TP, Tovar OH, Tillman DB, Schultz DB. Pacemaker and ICD generator malfunctions: Analysis of Food and Drug Administration annual reports. JAMA 2006 295 : 1901 1906.
6. Moore J. ICD recalls should be handled better. Today Cardiol 2005 8 : 1 9.
7. Cuculi F, Herzig W, Kobza R, Erne P. Psychological distress in patients with ICD recall. Pacing Clin Electrophysiol 2006 29 : 1261 1265.
8. Van Den Broek KC, Denollet J, Nyklicek I, Van Der Voort PH. Psychological reaction to potential malfunctioning of implantable defibrillators. Pacing Clin Electrophysiol 2006 29 : 953 956.
9. Sears SF Jr., Conti JB. Psychological aspects of cardiac devices and recalls in patients with implantable cardioverter defibrillators. Am J Cardiol 2006 98 : 565 567.
10. Burke JL, Hallas CN, Clark-Carter D, White D, Connelly D. The psychosocial impact of the implantable cardioverter defibrillator: A meta-analytic review. Br J Health Psychol 2003 8 (Pt 2 165 178.
11. Sears SF, Conti JB, Curtis AB, Saia TL, Foote R, Wen F. Affective distress and implantable cardioverter defibrillators: Cases for psychological and behavioral interventions. Pacing Clin Electrophysiol 1999 22 : 1831 1834.
12. Spielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA. Manual for the State-Trait Anxiety Inventory (Self Evaluation Questionnaire: Form Y). Palo Alto, CA, Consulting Psychologist Press, 1983.
13. Ware J, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: Construction of scales and preliminary tests of reliability and validity. Med Care 1996 34 : 220 233.
14. Burns JL, Serber ER, Keim S, Sears SF. Measuring patient acceptance of implantable cardiac device therapy: Initial psychometric investigation of the Florida Patient Acceptance Survey. J Cardiovasc Electrophysiol 2005 16 : 384 390.
15. Heart Rhythm Society. Proceedings document from the policy conference on pacemaker and ICD performance. Available at : http://www.hrsonline.org/ uploadDocs/HRS_A Device-Perfor mance-Recommendations-Apr06.pdf. Accessed October 16, 2006.
16. Carlson MD, Wilkoff BL, Maisel WH, Carlson MD, Ellenbogen KA, Saxon LA, Prystowsky EN, et al. Recommendations from the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines Endorsed by the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) and the International Coalition of Pacing and Electrophysiology Organizations (COPE). Heart Rhythm 2006 3 : 1250 1273.
17. Maisel WH, Sweeney MO, Stevenson WG, Ellison KE, Epstein LM. Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillator generators. JAMA 2001 286 : 793 799.