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Patient Evaluation of Implantable Cardioverter Defibrillator Recall Communication Strategies

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Title:
Patient Evaluation of Implantable Cardioverter Defibrillator Recall Communication Strategies
Creator:
STUTT, LAUREN ASHLEY ( Author, Primary )
Copyright Date:
2008

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Anxiety ( jstor )
Clinical psychology ( jstor )
Defibrillators ( jstor )
Demography ( jstor )
Electrophysiology ( jstor )
Heart ( jstor )
International Statistical Classification of Diseases ( jstor )
Physicians ( jstor )
Psychology ( jstor )
Psychosociology ( jstor )

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University of Florida
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University of Florida
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Copyright Lauren Ashley Stutt. Permission granted to the University of Florida to digitize, archive and distribute this item for non-profit research and educational purposes. Any reuse of this item in excess of fair use or other copyright exemptions requires permission of the copyright holder.
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5/31/2009

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1 PATIENT EVALUATION OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR RECALL COMMUNICATION STRATEGIES By LAUREN ASHLEY STUTTS A THESIS PRESENTED TO THE GRADUATE SCHOOL OF THE UNIVERSITY OF FLOR IDA IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF MASTER OF SCIENCE UNIVERSITY OF FLORIDA 2007

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2 2007 Lauren Ashley Stutts

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3 To all who nurtured my intellectual curiosity, academic interests, and sense of scholarship throughout my lifetime, maki ng this milestone possible

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4 ACKNOWLEDGMENTS I am greatly appreciative of my mentor, Dr. Samuel F. Sears, for his thorough guidance and support from the preliminary stages of this project to the concluding chapters. I would like to extend gratitude to Dr. Jamie Conti, Dr. Juan Aranda, Dr. William Miles, Dr. Thomas Burkart, and all the other members of the electrophysiology service at Shands Hospital. Furthermore, I would like to thank Dr. Michael Marsiske of the Department of Clinical and Health Psychology for his consultation on statistical analyses. I wo uld also like to acknowledge the members of my supervisory committee (Dr. James Johnson, Dr. De idre Pereira, and Dr. William Perlstein). Additionally, I would like to thank my family, friends, and classmates for their support and encouragement. Finally, I would like to extend my heartfelt appreciati on to the ICD patients who participated in this research.

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5 TABLE OF CONTENTS page ACKNOWLEDGMENTS...............................................................................................................4 LIST OF TABLES................................................................................................................. ..........7 LIST OF FIGURES................................................................................................................ .........8 ABSTRACT....................................................................................................................... ..............9 CHAPTER 1 INTRODUCTION..................................................................................................................11 Device Malfunctions............................................................................................................ ...11 Recall Process................................................................................................................. ........12 Physician-Patient Communication..........................................................................................13 Current Study.................................................................................................................. ........15 2 MATERIALS AND METHODS...........................................................................................16 Procedure...................................................................................................................... ..........16 Participants................................................................................................................... ..........16 Measures....................................................................................................................... ..........18 3 RESULTS...................................................................................................................... .........23 Descriptive Analyses........................................................................................................... ...23 Source of Recall............................................................................................................... .......24 Personal Relevance of Recall.................................................................................................24 Post-Vignette Data............................................................................................................. .....24 4 DISCUSSION..................................................................................................................... ....34 Clinical and Research Implications........................................................................................35 Limitations.................................................................................................................... ..........37 5 SUMMARY AND CONCLUSION.......................................................................................39 Summary........................................................................................................................ .........39 Conclusion..................................................................................................................... .........39 APPENDIX A POST-VIGNETTE QUESTIONNAIRE................................................................................41 B DEVICE RECALL INFORMATION SHEET.......................................................................43

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6 LIST OF REFERENCES............................................................................................................. ..44 BIOGRAPHICAL SKETCH.........................................................................................................48

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7 LIST OF TABLES Table page 2-1 Demographic variables of total sample (N = 66)...............................................................21 2-2 Six vignette types by source and relevance.......................................................................22 2-3 Twelve statements related to vignette................................................................................23 3-1 Descriptive analyses of psychosocial measures.................................................................27 3-2 Descriptive analyses of vignette questions........................................................................28 3-3 Descriptive analyses of vignette ques tions by source and relevance group......................29

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8 LIST OF FIGURES Figure page 3-1 Confidence in source of recall...........................................................................................30 3-2 Personal relevance of a recall............................................................................................31 3-3 Actual recall source........................................................................................................... .32 3-4 Preferred recall source.......................................................................................................33

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9 Abstract of Thesis Presen ted to the Graduate School of the University of Florida in Partial Fulfillment of the Requirements for the Degree of Master of Science PATIENT EVALUATION OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR RECALL COMMUNICATI ON STRATEGIES By Lauren Ashley Stutts May 2007 Chair: Samuel F. Sears Major: Psychology Communication to patients about the unpreced ented number of implantable cardioverter defibrillator (ICD) recalls ha s proved challenging and may ha ve resulted in increased psychological distress. While st udies have explored the psychological impact of recalls on patients, the best way to communi cate recalls is not currently know n. This study investigated the factors that affect communication of a recall on psychological distress. Sixty-six ICD patients read one of six vigne ttes that informed them of a hypothetical device recall. Variables incl uded the source of recall dissemi nation (physician vs. media vs. manufacturer) and the pers onal relevance (own brand is recalled vs. different br and is recalled). Subsequently, patients rated thei r agreement to 12 statements c oncerning their discomfort in learning about the recall on a scale from 1 ( strongly disagree ) to 5 ( strongly agree ). Results indicated that patients were significan tly more confident in the accuracy of recall information from both their physician and their device manufacturer compared to the media, Pearson 2 (2) = 22.39, p < .01. Interestingly, patients were not differentially concerned about the recall based on whether their brand was reca lled or a different brand was recalled. Furthermore, survey results in dicated that approximately 78.6% of patients reported learning

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10 about recalls from the media. In stark contrast , 77% of patients asserted a preference for learning about recalls from their physician. ICD patients report equivale nt trustworthiness from phys icians and manufacturers compared to the media in reporting recall inform ation, which suggests that patients maintain perceived value in manufacturer integrity. Most ICD patients, however, le arn about recalls from the media. Collectively, these results connote a po ssible disconnect between the initial source of recall information compared to the patients’ desired sources.

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11 CHAPTER 1 INTRODUCTION Cardiovascular disease is the number one cause of death in the United States (American Heart Association, 2007). In fact, every year more than 335,000 individuals die from sudden cardiac death (SCD) due to ve ntricular arrhythmias (Myer burg & Castellanos, 1997). The implantable cardioverter defibrilla tor (ICD) is a biomedical device designed to contravene lethal arrhythmias by automatically delivering an electrical cardioverting shock to defibrillate the heart and restore a normal sinus rhythm. It was a pproved as a safe devi ce in 1985 and is now implanted in over 150,000 Americans every year. Research indicates that the ICD is superior to pharmacological treatment in preventing SC D due to ventricular arrhythmias (AVID Investigators, 1997; Bardy et al ., 2005; Buxton et al., 1999; Moss et al., 1996). As a result, the number of devices implanted a nd the number of lives saved has grown steadily each year. Device Malfunctions Despite the advantages of biomedical de vices, manufactured products often have malfunctions (Myerburg, Feigal, & Lindsay, 2006). The ICD, in particular, has periodically had complications in recent years (Alter, Waldhans, Plachta, Moos dorf, & Grimm, 2005; Glikson & Friedman, 2001; Wilkoff, 2006). Some procedur e-related malfunctions include atrial or ventricular lead dislodgment, device failure, pocke t infection, device migration, change in lead position, diaphragmatic stimulation, and subclavian stenosis. In spite of those malfunctions, implant mortality is typically low, however (< 1%). Post-implant complications could include lead conductor fracture, breach of insulation, or tip dislodgment. When a device fails or has a malfunction, indust ry and federal regulatory agencies issue what they deem a “recall” (Gould & Krahn, 2006) . The three major U.S. ICD manufacturers (Medtronic, St. Jude Medical, and Boston Scientif ic/Guidant) have all issued recalls in recent

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12 years. For example, St. Jude Medical issued a recall in October 2005 because their St Jude Photon DR, Photon Micro VR/DR, a nd Atlas VR/DR ICDs contained a memory chip that can be affected by atmospheric radiation, which can impa ir pacing and delivery of therapies (risk of failure = .17) (Gould & Krahn, 2006). Moreover, Gu idant’s Ventak Prizm 2 DR ICD had a short circuit caused by a wire insulation problem within the lead connector block and issued a recall in June 2005 (risk of failure = .1). Medtronic also had a recall for their Marquis ICD because an internal battery short caused an accelerated ba ttery depletion (risk of failure = .01). Although ICD malfunctions such as these have been increasi ngly frequent in the past several years, current ICD advisories associate devices with having a risk of failure ranging from 0.0009% to 2.6% of devices during a variable follow-up period (usu ally less than 24 months) (Gould & Krahn, 2006). Recall Process Fortunately, the United States has a system atic way for device malfunctions to be reported and regulated by the Food and Drug Admi nistration (FDA) (Maisel, 2004a). In fact, specific acts and policies have been passed to en sure their safety. Specifically, Congress enacted the Safe Medical Devices Act in 1990 and the Medical Device Amendments in 1992 (Maisel, 2005). These acts require manufact urers to report to the FDA a ny device malfunction that could cause serious injury to the patient. Additiona lly, registries are employed to monitor device malfunctions. For example, the Multicenter Registry funded by th e Minneapolis Heart Institute Foundation gathers data for ICD and pacemaker pulse generator and lead failures (Hauser et al., 2006). After reporting the device malfunction to the FDA, manufacturers typically notify physicians with a letter that cons ists of the following information: a description of deaths that have already occurred, a list of existing patient conditions th at could contribute to the malfunction, an assessment of the malfunction’s ef fects on different segments of the population,

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13 the severity of injur y, the likelihood of occurre nce of the malfunction, and the consequences of the malfunction (Heart Rhythm Society, 2005). A lthough this process is time-intensive, it is necessary to inform healthcare individuals abou t the malfunction thoroughly and appropriately. The response to device malfunctions is also ma rkedly cost-intensive. In fact, the U.S. spent $870 million in medical care in response to de vice-related recalls in the U.S. between 1990 and 2000; three-quarters of that cost was accounted for by ICD recalls (Maisel, Sweeney, Stevenson, Ellison, & Epstein, 2001). Moreover, reca lls have resulted in many lawsuits against manufacturers. For example, Bost on Scientific faces over 550 indivi dual or class suits related to the recalls of 2006 and will likely spend billio ns of dollars to defend and compensate for damages (Herper & Langreth, 2006). Whereas the reporting pro cess of physicians to manu facturers and the FDA about malfunctions is relatively systematic, the communication of the recalls to patients is not regulated effectively. In fact , the media often quickly receive s information about recalls and relays the information through th e newspaper, television, or other mass media means (Maisel et al., 2006; Meier, 2006; Moore, 2006). The media ha s often portrayed ICD recalls in a negative light; therefore, manufacturers and physicians have been particularly co ncerned that patients’ trust, in general, about ICDs was fractured by the cascade of reca ll events in the media. This attention has evoked questions concerning how pa tients should be informed about recalls. Physician-Patient Communication Physicians are typically the conduits of communicating individual negative health information to patients. The physician-patient relationship is already em otionally-laden because the possibility of having an illness evokes fears such as death, disability, bodily harm, and separation from loved ones (Zeldow & Makoul, 2006). Therefore, it is central for physicians to communicate information to patients as appropriately as possible.

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14 One key reason for attempting to evaluate this communication process is that psychological distress is already problematic for pa tients with ICDs (Burke , Hallas, Clark-Carter, White, & Connelly, 2003; Godemann et al., 2004; Sears & Conti, 2002, 2003). In fact, the most common psychological response of ICD patients has been symptoms of fear and anxiety, with 24% to 87% of patients reporting symptoms of anxiety (Lemon, Edelman, & Kirkness, 2004; Sears & Conti, 2003). Furthermore, approximate ly 24% to 38% report significantly elevated levels of depression (Sears et al., 1999). Significant eviden ce suggests that psychological distress can affect not only quality of life (QOL) but also health outcomes (Rozanski, Blumenthal, & Kaplan, 1999). It is likely that learning about a recall w ill increase patients’ anxiety. Therefore, physicians may need to tailor their means of communication to each indi vidual, as recalls will not likely affect all ICD patients equally. In fact, patients who m eet the following risk factors for poor psychological adjustment to the ICD may need to be co nsidered carefully: younger age (<50 years), female, multiple-shock experience, poor understanding of condition or device, severe co-morbidities, and history of psychologi cal difficulties (Sears, Todaro, Lewis, Sotile, & Conti, 1999). Two recent studies explored th e impact of device complications on patients’ psychosocial functioning and found discrepant re sults (Sears & Conti, 2006). For example, a study in Switzerland demonstrated decreased psychological distress in patients who learned their device was recalled compared to their amount of distre ss prior to learning a bout the recall (Cuculi, Herzig, Kobza, & Erne, 2006). On the other hand, a study in the Netherlands found increased psychological distress in patients after they learned their device was recalled (van den Broek,

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15 Denollet, Nyklicek, & van der Voort, 2006). Theref ore, the psychological impact of a recall is not clearly understood. Although some studies have explored the psycho logical impact of r ecalls, there is very little research on the optimal way to communicate recalls to patients. In fact, it appears that there are substantial differences in opinion among physicians on how recalls should be managed (Maisel, 2004b). However, it is widely accep ted that recall information should be timely, accurate, updated, and complete (Heart Rhythm Society, 2005). Communicating effectively is important because accurate inform ation may allow patients to garner a sense of control during an uncontrollable event such as device recall. Current Study The overall purpose of the current study wa s to examine the preferred methods to communicate recall information to ICD patients. This study utilized vigne ttes to increase the salience of the recall. Research has shown that the vignette method has successfully been used as a research manipulat ion (Maisel, 2004b; Sears, Marhef ka, & Rodrigue, 2000). The specific aims of this study were as follows : (1) to investig ate how the source of hypothetical recall information (physician vs. media vs. manufactur er) may affect patients’ emotional responses, and (2) to investigate how the personal relevanc e of a hypothetical recall (recall of own brand vs. recall of a different brand) may affect patients ’ emotional responses. For the first aim, it was hypothesized that patients who learn about a reca ll from a physician will report more confidence in the accuracy of the recall in formation than patients who learn about a recall from the media or a manufacturer. For the second aim, it was hypot hesized that patients wh ose own brand of ICD is recalled will report more discomfort than patie nts who learn that a different brand is recalled.

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16 CHAPTER 2 MATERIALS AND METHODS Procedure ICD patients were recruited by medical staff at outpatient cardiac clinics at Shands Hospital at the University of Florida, Card iology West, and at an ICD support group meeting sponsored by Shands. Subsequently, patients we re referred to the Cardiac Psychology Research Team, who introduced the study and obtained informed consent from appropriate patients. Next patients were asked to complete an individual psychological asse ssment battery and return it to the researcher prior to leaving the clinic or fi nishing it at home and maili ng it to the researcher. The assessment battery took approximately 30 mi nutes to complete. It consisted of demographic, anxiety, health-related quality of life (QOL), and device acceptance questionnaires. Subsequently, patients were rand omly assigned to read one of six vignettes pertaining to a hypothetical recall of ICDs. Af ter reading the vignette, they rated their confidence, anxiety, and other feelings toward the recall on a Likert scale. Then patients completed a post-vignette questionnaire to meas ure their experiences with recalls, how they would want to hear about them, and how they w ould respond to the reca ll. Upon completion and submission of the assessment questionnaires, patien ts completed participa tion in the study. Data was subsequently entered into an SPSS database. Each patient was assigned a number to ensure anonymity and confidentiality. Medical record review was also conducted for information regarding illnesses and ICD-specific data. Participants Of the 66 participants, 44 were male (66.7%) and 22 were female (33.3%). The mean age of the sample was 61.09 ( SD = 13.87) with a range of 33 to 93 years of age. Ethnically, 89.4% of participants self-rated as Caucasian, 9.1% rated as African Am erican, and 1.5% rated

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17 as Hispanic. The majority of participants were reportedly married (66.7%), 16.7% reported being separated or divorced, 10.0% reported be ing widowed, 3.3% reported being single and never married, and 3.3% reported living with a pa rtner. Of the total sample, 69.4% reported obtaining a high school degr ee or less, 22.6% reported obtaini ng a college degree or less, and 8.0% reported obtaining some graduate education. The majority of participants were reportedly retired (48.5%), 28.8% reported receiving disability payments from the government, 12.1% reported working full-time, 7.6% reported wo rking part-time, and 3.0% reported being unemployed. Table 2-1 provides demographic information for the total sample of ICD patients. Patients’ medical records were reviewed to obtain information on bi omedical indices. Approximately 50% of patients were diagnosed with ischemic cardiomyopathy and 50% were diagnosed with nonischemic cardiomyopathy. Of th e entire sample, 34.8% were diagnosed with coronary artery disease and 15.2% met criteria for congest ive heart failure. This sample of ICD patients had a mean ejection fr action of approximately 27.95% ( SD = 14.88). The average length of time with the ICD was 3.32 years. Furthermore, patients were asked to provi de information on their past and present psychological treatment. Regard ing past psychological treatm ent, 12.1% patients reported undergoing psychotherapy and 16.7% patients reported taking psychotropic medications. Regarding current psychological treatment, 6.2% reported undergoing psychotherapy and 21.2% reported taking psychotropic medications. The number of patients in each group was as follows: (1) physician and own brand ( n = 13), (2) media and own brand ( n = 10), (3) manufacturer and own brand ( n = 12), (4) physician and different brand ( n = 10), (5) media a nd different brand ( n = 11), and (6) manufacturer and different brand ( n = 10). Chi-square analyses were c onducted for all demogr aphic and medical

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18 variables to assess for significan t demographic or medical differe nces among the six groups. No significant differences were found for any of th e variables. Therefore, the six groups are relatively homogeneous and differences in resp onses are likely due to the design manipulation. Measures Demographics. A standard demographics questionnair e gathered information such as age, gender, ethnicity, marital st atus, educational status, employ ment status, and past and/or present use of psychotropic medi cation and psychological treatment. Medical variables. Pertinent medical information was documented from the patient’s medical record including the medical reason/indica tion for the implant, th e most current ejection fraction, the amount of time with the ICD, and whether or not their device was included in a recall. Anxiety. The State Trait Anxiety Invent ory (STAI)-Trait version, a 20-item psychological test of anxiety in h ealth research, was utilized to a ssess trait anxiety, defined as a relatively enduring personality characteristic (S pielberger, 1983). It is widely used and psychometric reliability and validity have been es tablished. For example, test-retest stability coefficients for the STAI-Trait scale are re ported at .73 for males and .77 for females. Health-related quality of life. General health-related QOL was assessed with the Medical Outcomes Study-Short Fo rm-12 Health Survey (SF-12), a 12-item revision of the SF-36 Health Survey. It was designed to reproduce the Physical Component Summary (PCS) and the Mental Component Summary (MCS) scores of th e original SF-36 measure. Compared to its predecessor, each of the SF-12 summary scales acc ount for over 90% of the variance in the SF36 scales, demonstrate strong test -retest reliability (.89 for the PCS; .76 for the MCS) and correlate highly with the SF-36 summary scales (Ware, Kosinski, & Keller, 1996).

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19 Patient acceptance of ICDs. The Florida Patient Acceptance Survey (FPAS) is a valid and reliable 18-item measure that was used to assess patient accep tance of cardiac device treatments (Burns, Serber, Keim, & Sears, 2005). Patient acceptan ce refers to achieving maximal benefit from a biomedical device such as an ICD. The FPAS is comprised of four consistent factors: Return to Life, Device-Rela ted Distress, Positive Appraisal, and Body Image Concerns. This measure has demonstrated conver gent, divergent, and predictive validity when compared to other self-report measures such as the SF-36, Atrial Fibri llation Symptom Severity Scale, CES-D, STAI, and the Illn ess Intrusive Rating Scale. Vignettes. Six written vignettes were designed. They differed on two main factors: source of recall information (phys ician vs. media vs. manufacturer ) and personal relevance of the recall (recall of the patient’s sp ecific brand of ICD vs. recall of a different brand). The vignette read as follows: Many companies manufacture implantabl e cardioverter defibrillators (ICDs) like the one you have. [One of th e six sentences in Table 2-2 inse rted here.] All people whose devices are affected by the recall have the pote ntial to experience serious adverse consequences or even death. Following each vignette, patients responde d to 12 statements on a 5-point Likert scale from 1 ( strongly disagree ) to 5 ( strongly agree ). Table 2-3 reports the 12 statements. For six of the questions, resp onding with “agree” indicated a positive response to th e recall and for six of the questions, responding w ith “agree” indicates a negative response to the recall. Positiveand negative-framed questions were alternated. A manipulation check of the vignette was also included such that pati ents reported being able to imagine themselves in the vignette setup on a scale from 1 ( not at all ) to 5 ( very much ).

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20 Post-vignette Questionnaire. The final questionnaire cons isted of nine items aimed to assess patients’ experiences with recalls, the method in which they would prefer to hear about a recall, and how they would respond to th e announcement of a recall (Appendix A).

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21 Table 2-1. Demographic variables of total sample (N = 66). Demographic variables n / % Gender Males Females 44 / (66.7%) 22 / (33.3%) Mean Age 61.09 ( SD = 13.87) Ethnicity Caucasian African American Hispanic 89.4% 9.1% 1.5% Marital Status Married, remarried Separated, divorced Widowed Single, never married Living with a partner 66.7% 16.7% 10.0% 3.3% 3.3% Education High school degree or less College degree or less Graduate 69.4% 22.6% 8.0% Employment Retired Disability/Government Full time Part time Unemployed 48.5% 28.8% 12.1% 7.6% 3.0%

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22 Table 2-2. Six vignette type s by source and relevance. SOURCE PERSONAL RELEVANCE Physician Media Manufacturer Own brand Imagine your physician informs you that there has been a device recall of your brand of ICD. Imagine the media (newspaper) informs you that there has been a device recall of your brand of ICD. Imagine your ICD manufacturer informs you that there has been a device recall of your brand of ICD. Different brand Imagine your physician informs you there has been a device recall by a company different than the one that manufactured your ICD. Imagine the media (newspaper) informs you that there has been a device recall by a company different than the one that manufactured your ICD. Imagine your manufacturer informs you that there has been a device recall by a company different than the one that manufactured your ICD.

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23 Table 2-3. Twelve statem ents related to vignette. 12 Statements 1. I would feel confident that ___ (the source) would provide accurate information about the device recall. 2. I would feel more anxious if I learned a bout device recall from my physician rather than from another source. 3. I would feel protected by my ICD af ter learning about the device recall. 4. I would want my device to be replaced immediately. 5. I would not be concerned about the device recall. 6. I would feel more depressed after find ing out about a device recall than I felt beforehand. 7. I don’t think my loved ones would be impacted by the device recall. 8. I would feel more anxious after finding out about a device recall than I felt beforehand. 9. I would acknowledge that IC Ds are technological devi ces subject to failure. 10. I would feel unprepared to handle the announcement of a device recall. 11. I would still be satisfied with my decision to receive an IC D despite the device recall. 12. I would feel that my loved ones woul d be anxious about the device recall.

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24 CHAPTER 3 RESULTS The following statistical analyses were c onducted to evaluate the hypotheses for this research project. The Statistical Package for So cial Sciences (SPSS) was used to analyze the data. An alpha level of .05 was used for all stat istical tests. Variables were examined on a list wise basis; therefore, patients who did not comple te all measures were not included in analyses. Descriptive Analyses As demonstrated based on the descriptive anal yses in Table 3-1, the mean levels of trait anxiety, general health, and device acceptance of th e sample were in the normal range (Burns et al., 2005; Spielberger, 1983; Ware et al., 1996). The Physical Component Scale of the SF-12 was mildly impaired; however, considering the sa mple of patients had cardiac conditions, it is normal for them to report mildly impaired phys ical functioning. Re garding relationships between the variables, there was an expected significant negative co rrelation between FPAS score and Trait Anxiety score [ r (64) = -0.66, p < .01], FPAS score and SF-Mental score [ r (64) = -0.49, p < .01], and Trait Anxiety score and SF-Mental score [ r (64) = -0.83, p < .01]. Therefore, when patient acceptance was low, patients tended to have high general anxiety and high mental health concerns. The descriptive analyses of the 12 vignette st atements are in Table 3-2. Eleven variables were all univariately normal according to the skewness and kurtosis values. However, item 11 had a significantly peaked kurtosi s. Table 3-3 presents the descriptive analyses of the 12 vignette statements separated by vignette source and personal relevance. Clearly, there was not significant variability among most of the items between groups. In fact, when factor analysis was attempted, clear factors did not emerge. Ther efore, chi-square anal yses were conducted on the two most pertinent items for the specific aims. For the two items, the frequency of

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25 agreement / disagreement were used in the an alyses for the vignette source and personal relevance variable. Source of Recall The first critical item targeted patients’ though ts about the source of the recall. Patients differentially agreed with the following statement: “I would feel confident that the source would provide accurate information abou t the device recall” (Figure 3-1). Chi-square analyses revealed a significant difference for the source factor, Pearson 2 (2) = 22.39, p < .01. As expected, patients were significantly more confident in th e accuracy of the information from the physician ( M = 4.87, SD = .34) than the media ( M = 2.62, SD = 1.16). However, it was surprising to find that patients were also significan tly more confident in the accuracy of the information from the manufacturer ( M = 4.36, SD = 1.05) than the media ( M = 2.62, SD = 1.16). Personal Relevance of Recall The second critical item targeted the importan ce of the personal rele vance of the recall. Patients largely disagreed with the following statement: “I woul d not be concerned about the device recall” (Figure 3-2). There was not a significant difference between the conditions; therefore, patients were concerned about recall s regardless of whether their brand was recalled ( M = 2.06, SD = 1.33) or a different brand was recalled ( M = 2.58, SD = 1.52). Post-Vignette Data Based on the post-vignette questionnaire, pati ents reported it was relatively easy to imagine themselves in the vignette across the six versions ( M = 3.63, SD = 1.22), which suggests the effectiveness of the hypothetical vignette in reflecting reality. In fact, this ability of patients to imagine themselves in the vignette did not differ significantly based on the six vignette versions ( M ranged from 3.11 to 3.92). Moreover, 88.5% of patients reported being aware of the recalls prior to this study. Of that percenta ge, 80% reported learning about recalls from the

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26 media. As is demonstrated by Figure 3-3, minima l patients reported lear ning about recalls from the manufacturer or the physician. In stark cont rast, 80% reported pref erring to learn about recalls from their physician and only 1% would pr efer to learn about recalls from the media (Figure 3-4). Concerning specific recall met hods from the physician, 54.5% of patients wanted to learn about recalls from their physician in person, 25.8% over the phone, and 10.6% in a letter. Furthermore, 61.9% of patients stated that th ey would not take le gal action against the manufacturer if their device was recalled.

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27 Table 3-1. Descriptive analys es of psychosocial measures. Domain Measures Mean (SD)Range Anxiety STAI – Trait Scores range 20-80 36.21 (11.01)Average Health-Related Quality of Life SF-12 Scores range 0-100 PCS: 33.72 (11.07) MCS: 50.97 (10.91) Mildly Impaired Average Device Acceptance FPAS Scores range 5 – 90 75.19 (16.10)Average

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28 Table 3-2. Descriptive anal yses of vignette questions. 12 Statements Skewness Kurtosis M ( SD ) 1. I would feel confident that ____ (the source) would provide accurate information about the device recall. -1.05-0.15 3.98 (1.32) 2. I would feel more anxious if I learned about device recall from my physician ra ther than from another source. -0.21-1.47 3.15 (1.55) 3. I would feel protected by my ICD after learning about the device recall. -0.10-0.92 3.12 (1.28) 4. I would want my device to be replaced immediately. -0.62-0.83 3.67 (1.37) 5. I would not be concerned about the device recall. 0.70-0.98 2.30 (1.44) 6. I would feel more depressed after finding out about a device recall than I felt beforehand. -0.03-1.41 2.85 (1.47) 7. I don’t think my loved ones would be impacted by the device recall. 0.71-0.84 2.26 (1.35) 8. I would feel more anxious after finding out about a device recall than I felt beforehand. -0.58-0.63 3.50 (1.30) 9. I would acknowledge that ICDs are technological devices subject to failure. -1.120.52 4.36 (0.82) 10. I would feel unprepared to handle the announcement of a device recall. 0.76-0.31 2.18 (1.32) 11. I would still be satisfie d with my decision to receive an ICD despite the device recall. -1.793.71 4.44 (1.55) 12. I would feel that my loved ones would be anxious about the device recall. -1.210.42 3.92 (1.28)

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29 Table 3-3. Descriptive analyses of vigne tte questions by source and relevance group. # Physician Own Brand M ( SD ) n = 13 Media Own Brand M ( SD ) n = 10 Manufacturer Own Brand M ( SD ) n = 12 Physician Diff Brand M ( SD ) n = 10 Media Diff Brand M ( SD ) n = 11 Manufacturer Diff Brand M ( SD ) n = 10 1 4.85 (0.38) 2.60 (1.26) 4.17 (1.27)4.90 (0.32)2.63 (1.12) 4.60 (0.70) 2 2.46 (1.76) 3.10 (1.52) 3.17 (1.47)3.00 (1.94)3.45 (1.04) 3.90 (1.37) 3 3.00 (1.22) 2.90 (1.45) 2.58 (1.24)3.70 (1.49)3.27 (0.79) 3.40 (1.43) 4 4.08 (0.86) 3.70 (1.25) 3.83 (1.53)3.80 (1.48)3.09 (1.58) 3.42 (1.52) 5 1.77 (1.01) 2.30 (1.70) 2.17 (1.34)3.20 (1.62)2.18 (1.25) 2.40 (1.65) 6 2.85 (1.52) 2.90 (1.20) 2.67 (1.30)2.90 (1.73)3.27 (1.62) 2.50 (1.65) 7 1.85 (1.21) 2.00 (1.25) 2.17 (1.40)2.60 (1.26)2.72 (1.35) 2.30 (1.70) 8 3.77 (1.48) 3.60 (1.35) 3.08 (1.16)3.50 (1.43)3.36 (1.29) 3.70 (1.25) 9 4.61 (0.65) 4.30 (0.67) 4.25 (0.97)4.00 (1.15)4.36 (0.67) 4.60 (0.70) 10 1.62 (0.77) 2.60 (1.07) 2.25 (1.29)2.70 (1.70)2.27 (1.19) 1.80 (1.03) 11 4.62 (0.51) 4.50 (0.71) 4.08 (1.31)4.60 (0.84)4.27 (0.79) 4.60 (0.70) 12 4.08 (1.26) 4.00 (1.25) 3.42 (1.44)3.90 (1.45)4.18 (0.87) 4.00 (1.41)

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30 1 2 3 4 5 PhysicianMedia Manufacturer SOURCEAGREEMENT (1 to 5) _ Own Brand Different Brand Figure 3-1. Confidence in source of recall. Ratings of agreemen t for the following statement: “I would feel confident in the accuracy of the source of r ecall information.” Error bars represent the standard error.

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31 0 1 2 3 4 5 PhysicianMedia Manufacturer SOURCEAGREEMENT (1 to 5) _ Own Brand Different Brand Figure 3-2. Personal relevance of a recall. Ratings of agreem ent for the following statement: “I would not be concerned about the device r ecall.” Error bars repr esent the standard error.

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32 0 10 20 30 40 50 60 70 80 90 100 PhysicianMediaManufacturer ACTUAL RECALL SOURCEPERCENTAGE _ Figure 3-3. Actual recall sour ce. Percentage of patients who learned about recalls from the physician, media, and manufacturer.

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33 0 10 20 30 40 50 60 70 80 90 100 PhysicianMediaManufacturer PREFERRED RECALL SOURCEPERCENTAGE _ Figure 3-4. Preferred recall source. Percenta ge of patients who would prefer to learn about recalls from the physician, media, and manufacturer.

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34 CHAPTER 4 DISCUSSION The current study examined ICD patient res ponses to hypothetical r ecall situations and demonstrated that both physicia ns and manufacturers are significan tly more desirable sources of information than the media. This result is su rprising considering the manufacturers’ possible role in the malfunctions. However, when examin ing patients’ responses to other items, they reported acknowledging that devices are subject to failure, which c ould lead them to absolve the manufacturer of that role. Moreover, it is likely patients realize that manufacturers are responsible for rectifying the malf unctions. Therefore, an elemen t of trust is inherent in the manufacturer-patient relationship and ha s not been eradicated by the recalls. The second aim of this study examined IC D patient concerns about recalls and demonstrated that patients are concerned about recalls regardless of whether their brand or a different brand is recalled. Although this is in contrary to expectations , it is an interesting finding because it suggests that re calls can initiate anxiety in all ICD patients, regardless of the brand. There are several reasons why this lack of difference could have resulted. For example, many patients are unaware of their specific bra nd of ICD and might become concerned because the recall could be targeted to their device. Fu rthermore, patients may be extra cautious because of the critical nature of the ICD. Lastly, pa tients could think the reca lls are indicative of a general problem with all ICDs and their device could be next. Based on the post-vignette data, patients reported learning about recalls predominantly from the media but reported preferring to le arn about them from their physician. These discrepant findings connote a disconnection in the current recall communication methods. However, practical issues arise from this discrepancy. It is likely not feasible to have physicians personally meet with patients to inform them about the recall. However, this research

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35 demonstrates that physicians should make an effort to meet patients in person or have an allied healthcare professional communicate information to patients over the phone. The importance of this type of communication is supported by Cuculi et al.’s (2006) finding of decreased psychosocial distress in patients with actual recalled devices. In their Swiss study, only six of their patients (20%) knew about the ICD recall before being contacted by the Department of Cardiology. As such, it follows that they would be less distressed because they learned about recalls from a trusted source, whereas 80% of U.S. patients in the cu rrent study learned about recalls from the media. Moreover, van den Broe k et al.’s (2006) study in the Netherlands found that patients’ anxiety was increa sed after learning about recalls from a public statement; this result provides additional evid ence for the negative effects of media communication about recalls on patients. Collectively, these results prov ide support for a change in communication of a recall in the United States. Clinical and Research Implications In light of this study’s findings, there are many clinical and research implications. First, this research provides potentia l guidelines for physicians, ma nufacturers, and the media for reducing the psychological impact of a recall. Re garding physicians, this research could show them appropriate ways to convey recalls to patien ts and manage them clinically. Moreover, it can help physicians respond to the concerns of potential ICD patient s. If a potential lCD patient over-rates the risk of a recall, then he or she may decide not to get an ICD for fear of it malfunctioning. Negative facts tend to be more sa lient than positive facts; therefore, cardiac patients may impulsively reject the ICD without weighing the costs and the benefits. As such, physicians need to be able to explain why getting an ICD would be worth the risk of a recall. Increased communication is needed between the physician and the patient such that patients receive timely, accurate, and individual ized information about recalls (Heart Rhythm

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36 Society, 2005). In fact, research has demonstrated that effect ive communication has been linked to increases in physician and patient satisfaction, adherence to treatment plans, improved health outcomes, and decreased incide nce of malpractice lawsuits (Zeldow & Makoul, 2006). The physician should create an environment of privacy, comfort, and sufficient time. In fact, it is often recommended that physicians follow the SEGUE framework, which is the most widely used model for teaching and assessing communicati on skills in North America. It involves setting the stage, el iciting information, giving inform ation, understanding the patient’s perspective, and ending the encounter appropr iately (Zeldow & Makoul, 2006). Additionally, physicians may want to distribut e information sheets to their pot ential or current ICD patients that delineate what patients should know if ther e is a device recall. In fact, the Heart Rhythm Society designed a recall handout for patient s, which is presented in Appendix B. Furthermore, this research could influence public policy and facilitate ongoing discussion about recall management (Carlson et al., 2006; Heart Rhythm Society, 2005). For example, since patients do not want to learn about recalls from the media, perhaps stricter regulations could be implemented on the media’s ability to release recall information. The implications of ICD recall research will be even further reaching as ICD indications are expanding (Maisel, 2003). In fact, research demonstrates that ICDs improve survival in an expanding population of patients as primary and s econdary prophylaxis; therefore, it is likely that implantation rates will increase (Goldberger & Lampert, 2006). Moreover, ICDs are becoming increasingly complex, which increases the probabi lity of malfunctions and subsequent recalls (Newman, Crystal, & Goldman, 2003). The result s of this study do not simply apply to ICD patients, however. In fact, ICD recall rese arch could generalize to communicating adverse effects of other medical devices and medications. As our so ciety becomes more and more

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37 technologically advanced, it is likely that future devices will have similar problems. Therefore, an effective communication model for recalls is vital. Limitations The current study contains notable limitations in the areas of part icipants, procedure, measures, and statistical analyses. Regarding pa rticipants, the sample size was relatively small and homogenous. A larger, more diverse sample is necessary to increase the external validity of this study’s findings. In fact, it would be efficacious to recruit pa tients from different areas of the United States and from different countries. It is likely that the methods of communication and preferences of communicati on vary across populations, whic h could markedly affect how patients would respond to a recall announcement. Regarding the procedure, this study examined data from a single time point and may not represent psychological responses to a recall over time. More over, the hypothetical vignette method could be improved. For example, a more powerful simulation could be using an actual newspaper to communicate a hypoth etical recall, havi ng the patient watch a physician relay recall information on a computer, and giving pa tients an actual letter from a manufacturer detailing the recall. Regarding the measures, the post-vignette qu estionnaire has not been psychometrically validated. Since clear factors did not emerge and since there was not a significant amount of variability between our variables, then more discriminating questions need to be added. With distinct factors, more powerful statistical te sts like analyses of variance (ANOVAs) could be utilized in lieu of the less pow erful chi-square analyses. Furthermore, the use of self-report meas ures may be influenced by patient demand characteristics, such as patient perception of how they should respond or how they would like themselves to be perceived (e.g., social desirab ility bias). Although attempts were made to

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38 minimize those effects (e.g., ensuring anonymity and confidentiality), patients’ responses could have been affected by those factors.

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39 CHAPTER 5 SUMMARY AND CONCLUSION Summary This study investigated the factors that affect communication of a recall on patients’ emotional responses. Sixty-six IC D patients read one of six vignett es that detailed a hypothetical device recall. Variables incl uded the source of recall dissemi nation (physician vs. media vs. manufacturer) and the pers onal relevance (own brand is recalled vs. different br and is recalled). Subsequently, patients rated th eir agreement to 12 statements concerning their emotional response in learning about the recall. Patients were significantly more confident in the accuracy of recall information from both their physician and their device manufacturer compar ed to the media. Interestingly, patients were not differentially concerned about the recall based on whethe r their brand was recalled or a different brand was recalled. As such, recalls can initiate anxiety in all ICD patients. Furthermore, survey results indi cated that patients re ported learning about recalls from the media but asserted a preference for l earning about recalls from thei r physician. Collectively, these results demonstrate a disconnection between the init ial source of recalls and the patients’ desired sources, suggesting that proactive dissemination of recalls from the physician would decrease recall anxiety. Conclusion Device safety issues will undoubtedly become more prevalent as physicians increasingly rely on technological advances to treat medical conditions and prol ong life. Most importantly, it appears that the method of comm unicating device malfunctions s hould occur in the context of the physician-patient relationship. Future studi es could address the changes indicated by our limitations; investigate what specific information patients need and want to learn about recalls;

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40 and assess the effects of recalls on other populations such as the family members of patients with recalled devices, potential ICD recipients, and physicians. Recall is just one end of th e continuum of potential advers e effects of treatment with medical devices. This research could genera lize into helping people handle learning about potential side effects of their de vices or medications. Therefore, public health could benefit from this information. Since technology is cons tantly evolving and becoming increasingly complicated, there will likely be more biomedical device recalls in the future (Maisel et al., 2001; Shang & Hooker, 2005). By developing an effective management plan for recall communication, patients have th e potential to respond calmly a nd appropriately, which could likely decrease the aversive ps ychological and possi ble physical effects of learning about a recall.

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41 APPENDIX A POST-VIGNETTE QUESTIONNAIRE 1. How much were you able to place yourself in the scenario? 1 2 3 4 5 Not at all Very much 2. What was the source of information in the scenario? Physician Media (Newspaper) Manufacturer 3. Which brand was recalled in the scenario? My brand Different brand 4. Are you aware of the recent ICD device recalls? Yes No If yes, how did you first hear about the recalls? (check all that apply) In person Internet Over the phone Newspaper Letter Television Email Other:__________________________________ 5. Has your device ever been recalled? Yes No If yes, when was your device recalled? Date: _________ Who was the manufacturer of that device? ___________________________ 6. If your device was recalled, from whom would you prefer to hear about the recall? (please rank 1-4 in order of preference) ___ Physician ___ Manufacturer ___ Media ___ Federal organization like the Food and Drug Administration 7. How would you prefer to be notified in the event of a recall? (please rank 17 in order of preference) ___ In person ___ Over the phone ___ Letter ___ Email ___ Internet

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42 ___ Newspaper ___ Television ___ Other:____________________________________________________ 8. What questions would come to mind if you learned your device was recalled? (check all that apply) Is the device still able to protect my life? Is it necessary to replace my device? Is there anything I can do to immediately protect myself? How quickly do I need to address this problem? Other:_____________________________________________________ 9. If your device was recalled, would you consider taking legal action against the manufacturer? Yes No If yes, under which circumstan ces? (check all that apply) If the manufacturer knew about th e defective devices but did not immediately inform the public If the defective device would nega tively affect my personal health I would consider taking legal action no matter what the reason for the recall

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43 APPENDIX B DEVICE RECALL INFORMATION SHEET Ves

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44 LIST OF REFERENCES Alter, P., Waldhans, S., Plachta, E., Moosdorf, R., & Grimm, W. (2005). Complications of implantable cardioverter defibrillator therapy in 440 consecutive patients. Pacing and Clinical Electrophysiology, 28 (9), 926-932. American Heart A ssociation. (2007). Heart disease and stroke statistics-2007 update . Retrieved January 15, 2007, from http://www.amer icanheart.org/downloadable/heart/ 1166712318459HS_StatsInsideText.pdf AVID Investigators. (1997). A comparison of an tiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. The Antiarrhythmics versus Implantable De fibrillators (AVID) Investigators. New England Journal of Medicine, 337 (22), 1576-1583. Bardy, G. H., Lee, K. L., Mark, D. B., Poole, J. E., Packer, D. L., Boineau, R., et al. (2005). Amiodarone or an implantable cardioverter-d efibrillator for congestive heart failure. New England Journal of Medicine, 352 (3), 225-237. Burke, J. L., Hallas, C. N., Clark-Carter, D ., White, D., & Connelly, D. (2003). The psychosocial impact of the implantable cardioverter defibrillator: A meta-analytic review. British Journal of Health Psychology, 8 (Pt 2), 165-178. Burns, J. L., Serber, E. R., Keim, S., & Sears, S. F. (2005). Measuri ng patient acceptance of implantable cardiac device therapy: Initial ps ychometric investiga tion of the Florida Patient Acceptance Survey. Journal of Cardiovascul ar Electrophysiology, 16 (4), 384390. Buxton, A. E., Lee, K. L., Fisher, J. D., Josephson, M. E., Prystowsky, E. N., & Hafley, G. (1999). A randomized study of the prevention of sudden death in patients with coronary artery disease. Multicenter Unsustai ned Tachycardia Trial Investigators. New England Journal of Medicine, 341 (25), 1882-1890. Carlson, M. D., Wilkoff, B. L., Maisel, W. H., Ellenbogen, K. A., Saxon, L. A., Prystowsky, E. N., et al. (2006). 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 Ameri can Heart Association (AHA) and the International Coalition of Pacing and Electrophysiology Organizations (COPE). Heart Rhythm, 3 (10), 1250-1273. Cuculi, F., Herzig, W., Kobza, R., & Erne, P. ( 2006). Psychological distress in patients with ICD recall. Pacing and Clinical Electrophysiology, 29 (11), 1261-1265.

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45 Glikson, M., & Friedman, P. A. (2001). The implantable cardioverter defibrillator. Lancet, 357 (9262), 1107-1117. Godemann, F., Butter, C., Lampe, F., Linde n, M., Werner, S., & Behrens, S. (2004). Determinants of the quality of life (QoL) in patients with an implantable cardioverter/defibrillator (ICD). Quality of Life Research, 13 (2), 411-416. Goldberger, Z., & Lampert, R. (2006). Implan table cardioverter-defib rillators: Expanding indications and technologies. Journal of the American Medical Association, 295 (7), 809818. Gould, P. A., & Krahn, A. D. ( 2006). Complications associated with implantable cardioverterdefibrillator replacement in re sponse to device advisories. Journal of the American Medical Association, 295 (16), 1907-1911. Hauser, R. G., Hayes, D. L., Epstein, A. E., Cannom, D. S., Vlay, S. C., Song, S. L., et al. (2006). Multicenter experience with faile d and recalled implantable cardioverterdefibrillator pulse generators. Heart Rhythm, 3 (6), 640-644. Heart Rhythm Society. (2005). Draft recommendations report by the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines. Retrieved October 16, 2005, from http://www.hrsonline.org/ uploadDocs/ HRS_Device-Performance-RecommendationsApr06.pdf Herper, M., & Langreth, R. (2006, November 27). Dangerous devices. Forbes, 94-104. Lemon, J., Edelman, S., & Kirkness, A. (2004) . Avoidance behaviors in patients with implantable cardioverter defibrillators. Heart and Lung, 33 (3), 176-182. Maisel, W. H. (2003). Impact of expanding indications on the safety of pacemakers and defibrillators. Cardiac Electrophysiology Review, 7 (1), 30-32. Maisel, W. H. (2004a). Medical device regulatio n: An introduction for the practicing physician. Annals of Internal Medicine, 140 (4), 296-302. Maisel, W. H. (2004b). Physician management of pacemaker and implantable cardioverter defibrillator advisories. Pacing and Clinical Electrophysiology, 27 (4), 437-442. Maisel, W. H. (2005). Safety issues involvi ng medical devices: implications of recent implantable cardioverter-defibrillator malfunctions. Journal of the American Medical Association, 294 (8), 955-958.

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46 Maisel, W. H., Moynahan, M., Zuckerman, B. D., Gro ss, T. P., Tovar, O. H., Tillman, D. B., et al. (2006). Pacemaker and ICD generator malfunctions: Analysis of Food and Drug Administration annual reports. Journal of the American Medical Association, 295 (16), 1901-1906. Maisel, W. H., Sweeney, M. O., Stevenson, W. G., Ellison, K. E., & Epstein, L. M. (2001). Recalls and safety alerts i nvolving pacemakers and implantabl e cardioverter-defibrillator generators. Journal of the American Medical Association, 286 (7), 793-799. Meier, B. (2006, June 7). Papers show Guid ant considered warning doctors of hazards . New York Times . Moore, J. (2006, April 11). Recalls have weakened defibrillator demand . Star Tribune . Moss, A. J., Hall, W. J., Cannom, D. S., Daubert , J. P., Higgins, S. L., Klein, H., et al. (1996). Improved survival with an implanted defibrilla tor in patients with coronary disease at high risk for ventricular arrhythmia. Multi center Automatic Defibrillator Implantation Trial Investigators. New England Journal of Medicine, 335 (26), 1933-1940. Myerburg, R. J., & Castellanos, A. (1997). Card iac arrest and sudden cardiac death. In E. Braunwald (Ed.), Heart disease: A textbook of cardiac medicine (pp. 742-779). Philidelphia: W.B. Saunders. Myerburg, R. J., Feigal, D. W., Jr., & Lindsay, B. D. (2006). Li fe-threatening malfunction of implantable cardiac devices. New England Journal of Medicine, 354 (22), 2309-2311. Newman, D., Crystal, E., & Goldman, B. (2003). The recall genie: Time to go back in the bottle. Pacing and Clinical Electrophysiology, 27 , 435-436. Rozanski, A., Blumenthal, J. A., & Kaplan, J. (1999). Impact of psychological factors on the pathogenesis of cardiovascular dise ase and implications for therapy. Circulation, 99 (16), 2192-2217. Sears, S. F., Jr., & Conti, J. B. (2002). Qua lity of life and psychological functioning of ICD patients. Heart, 87 (5), 488-493. Sears, S. F., & Conti, J. B. (2003). Understand ing implantable cardioverter defibrillator shocks and storms: medical and psychosocial consider ations for research and clinical care. Clinical Cardiology, 26 (3), 107-111. Sears, S. F., Jr., & Conti, J. B. (2006). Psychol ogical aspects of cardiac devices and recalls in patients with implantable cardioverter defibrillators. American Journal of Cardiology, 98 (4), 565-567.

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47 Sears, S. F., Conti, J. B., Curtis, A. B., Saia, T. L., Foote, R., & Wen, F. (1999). Affective distress and implantable cardioverter defi brillators: Cases for psychological and behavioral interventions. Pacing and Clinical Electrophysiology, 22 (12), 1831-1834. Sears, S. F., Marhefka, S. L., & Rodrigue, J. R. (2000). The role of patients' ability to pay, gender, and smoking history on public attitudes toward cardiac transplant allocation: An experimental investigation. Health Psychology, 19 (2), 192-196. Sears, S. F., Todaro, J. F., Lewis, T. S., Sotile, W., & Conti, J. B. (1999). Examining the psychosocial impact of implantable cardiov erter defibrillators: A literature review. Clinical Cardiology, 22 (7), 481-489. Shang, W., & Hooker, N. H. (2005). Improving recall crisis manage ment: Should retailer information be disclosed? Journal of Public Affairs, 5 , 329-341. Spielberger, C. D., Gorsuch, R. L., Lushene, R., Vagg, P. R., & Jacobs, G. A. (1983). Manual for the State-Trait Anxiety Inventory (Se lf Evaluation Questi onnaire: Form Y). Palo Alto: Consulting Psychologist Press, Inc. van den Broek, K. C., Denollet, J., Nyklicek, I ., & van der Voort, P. H. (2006). Psychological reaction to potential malfunctioning of implantable defibrillators. Pacing and Clinical Electrophysiology, 29 (9), 953-956. Ware, J., Kosinski, M., & Keller, S. D. (1996). A 12-item short-form health survey: construction of scales and preliminary tests of reliability and validity. Medical Care, 34 (3), 220-233. Wilkoff, B. L. (2006). Pacemaker and ICD malfunction: An incomplete picture. Journal of the American Medical Association, 295 (16), 1944-1946. Zeldow, P., & Makoul, G. (2006) . Communicating with patients. In D. Wedding & M. Stuber (Eds.), Behavior & medicine (4th ed., pp. 201-218). Cambridge, MA: Hogrefe.

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48 BIOGRAPHICAL SKETCH Lauren Ashley Stutts was born in Charlotte, North Carolina, on July 8th, 1983, to George and Karen Stutts. She has an older sister, Er yn, and a younger brother, Derek. Lauren graduated magna cum laude from Davidson College in May 2005 with a Bach elor of Science in psychology and a concentration in medical humanities. Lauren is currently residing in Gainesville, Florida and is pursuing a doctorate in clin ical and health psychology at the Un iversity of Florida. Lauren has had extensive clinical traini ng in a variety of medical set tings, specifically in inpatient pediatric units, helping children with cancer, sickle cell anemia, and diabetes, and in a physical rehabilitation unit assisting people with spinal cord injuries. Currentl y, Lauren volunteers at Shands Rehabilitation Hospital, predominantly wo rking with patients who have sustained spinal cord injuries. While she enjoys the rigors of conducting psychol ogical research, it is her clinical experiences with patients that have inspired her to pursue a professional care er in clinical health psychology. Lauren’s research interests in the fi eld include positive psychology, medical ethics, and general issues in the biopsyc hosocial care of patient health.