Patient Evaluation of ICD Recall Communication Strategies: A Vignette Study LAUREN A. STUTTS, M.S.,* JAMIE B. CONTI, M.D.,† JUAN M. ARANDA, JR., M.D.,† WILLIAM M. MILES, M.D.,† THOMAS A. BURKART, M.D.,† and SAMUEL F. SEARS, PH.D.* From the *Department of Clinical and Health Psychology, College of Public Health and Health Professions, †Division of Cardiovascular Medicine, College of Medicine, University of Florida Health Science Center, Gainesville, Florida Introduction: Communication about the unprecedented number of implantable cardioverter defibrillator (ICD) recalls has proved challenging. While initial studies have explored the psychological impact of recalls on patients, the optimal way to communicate recalls is not currently known. This study investigated the way communication of a recall can affect patients’ responses. Methods: Sixty-six ICD patients read one of six vignettes that detailed a hypothetical device recall. Vi- gnette variables included the source of recall dissemination (physician vs. media vs. device manufacturer) and the personal relevance (own brand is recalled vs. different brand is recalled). Subsequently, patients rated their agreement to 12 statements concerning their response to the recall on a scale from 1 (Strongly Disagree) to 5 (Strongly Agree). Results: Patients were significantly more confident in the accuracy of recall information from both their physician and their manufacturer compared with the media, F (2, 63) = 36.10, P < 0.01, η 2 = 0.53. Interestingly, patients were concerned about the recall regardless of whether their brand of ICD was recalled. Survey results indicated that 78.6% of patients reported learning about recalls from the media. In stark contrast, 77.0% of patients asserted preferring to learn about recalls from their physician. Conclusions: ICD patients report increased confidence in the accuracy of the recall information from physicians and manufacturers compared with the media in reporting recalls. Because it seems that most ICD patients learn about recalls from the media, these results demonstrate a disconnect between the initial source of recall information and the patients’ desired sources. (PACE 2007; 30:1105–1111) implantable cardioverter defibrillator, recall, anxiety, quality of life Introduction The major implantable cardioverter defibril- lator (ICD) manufacturers have issued an unprece- dented number of ICD recalls in the past several years. 1,2 In fact, the high number of recalls has led to an extraordinary amount of media attention. 3,4 Although the actual risk of failure is minimal, 5 the media reports seemed to present a markedly negative image of device-based care. 4,6 Manufac- turers and physicians have been particularly con- cerned that patients’ trust in ICDs was shaken by the cascade of recall events in the media. This at- tention has evoked questions concerning how pa- tients should be informed about recalls. Although studies have examined the psychological effects of recalls on ICD patients, 7,8 studies have not specif- ically investigated the optimal strategies to com- municate recall information to patients. 9 Research indicates that ICDs already induce significant anxiety. 10,11 In fact, 13% to 38% of ICD Address for reprints: Lauren Stutts, M.S., University of Florida, Department of Clinical and Health Psychology, Box 100165 UF Health Science Center, Gainesville, FL 32610. Fax: (352) 273- 6156; e-mail: lstutts@phhp.ufl.edu Received February 9, 2007; revised April 13, 2007; accepted June 11, 2007. patients experience diagnosable ICD-specific fears such as fear of shock and death. 11 Therefore, it is likely that having this device recalled could ex- acerbate the anxiety of an already apprehensive patient. Van den Broek et al. found that ICD pa- tients were significantly more likely to experience anxiety after a public statement about ICD recalls when compared with their baseline level of anxi- ety. 8 Alternatively, recalls could negatively affect potential ICD recipients. Specifically, patients may refuse ICD implantation because of fear of device malfunction. Increased anxiety in both ICD pa- tients and potential ICD patients is understandable because a recall threatens the reliability of an ICD and the secure knowledge that it will function cor- rectly. 9 The overall purpose of this study was to exam- ine the way communication of a recall can affect patients’ confidence in the accuracy of recall in- formation and concern about recalls. The specific aims of this study were as follows: (1) to investigate how the source of hypothetical recall information (physician vs. media vs. manufacturer) may affect patients’ responses, and (2) to investigate how the personal relevance of a hypothetical recall (recall of own brand vs. recall of a different brand) may affect patients’ responses. C 2007, The Authors. Journal compilation C 2007, Blackwell Publishing, Inc. PACE, Vol. 30 September 2007 1105