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BACKGROUND: A better understanding is needed of the burdens and benefits of left ventricular assist device (LVAD) implantation on patients’ physical, mental, and social well-being. The purpose of this report was to evaluate the validity of Patient-Reported Outcomes Measurement Information System (PROMIS) measures for LVAD patients and to estimate clinically important score differences likely to have implications for patient treatment or care. METHODS: Adults from 12 sites across all US geographic regions completed PROMIS measures ≥3 months post-LVAD implantation. Other patient-reported outcomes (eg, Kansas City Cardiomyopathy Questionnaire-12 item), clinician ratings, performance tests, and clinical adverse events were used as validity indicators. Criterion and construct validity and clinically important differences were estimated with Pearson correlations, ANOVA methods, and Cohen d effect sizes. RESULTS: Participants’ (n=648) mean age was 58 years, and the majority were men (78%), non-Hispanic White people (68%), with dilated cardiomyopathy (55%), long-term implantation strategy (57%), and New York Heart Association classes I and II (54%). Most correlations between validity indicators and PROMIS measures were medium to large (≥0.3; p CONCLUSIONS: The findings provide convincing evidence for the relevance and validity of PROMIS physical, mental, and social health measures in patients from early-to-late post-LVAD implantation. Findings may inform shared decision-making when patients consider treatment options. Patients with an LVAD, their caregivers, and their clinicians should find it useful to interpret the meaning of their PROMIS scores in relation to the general population, that is, PROMIS may help to monitor a return to normalcy in everyday life. REGISTRATION: URL: https://clinicaltrials.gov ; Unique: identifier: NCT03044535.

Introduction: Improvement in social functioning is an important goal for advanced heart failure (HF) patients (pts) who receive left ventricular assist devices (LVADs). Self-reported social functioning and its association with clinical change is understudied. Methods: Adult HF pts who received LVADs at nine U.S. sites completed two measures of social functioning prior to, and 3-6 months after, surgery. Patient-Reported Outcomes Measurement Information System (PROMIS) measures were: Ability to Participate in Social Roles and Activities (Ability) and Satisfaction with Social Roles and Activities (Satisfaction). PROMIS uses T-scores standardized to a U.S. general population (mean=50; standard deviation, SD=10); higher scores represent better outcomes. New York Heart Association (NYHA) Functional Classification was assigned at both times by treating clinicians; change was subsequently categorized as Better, Same or Worse NYHA. Linear mixed effects models and least-squares means were estimated for Ability and Satisfaction. Results: Pts ( n =107) were primarily male (78%) and non-Hispanic White (68%); mean age (SD)=54 (12.5) years; 74% were NYHA Class IV prior to surgery and only 18% were NYHA IV at follow-up. NYHA was better for the majority ( n =75, 70%); 24% ( n =26) were the same, and 6% ( n =6) were worse. Mean Ability and Satisfaction were lower than the general population mean of 50 at both time points (Figure). Ability improved for the NYHA Better ( p p =0.030) groups, and nominally decreased for the Worse group ( p =0.800). Satisfaction improved for the Better ( p p >0.300). Conclusions: Self-reported social functioning measures were responsive to clinician-rated clinical change. Understanding these relationships may guide clinicians in providing targeted health-related quality of life therapies to improve social functioning.

Purpose To evaluate the validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) generic measures of social and physical function in patients with a left ventricular assist device (LVAD). Methods Adult heart failure (HF) patients at 12 U.S. sites in 2016-2020 enrolled in The Mechanical Circulatory Support: Measures of Adjustment and Quality Of Life Study (n=361). Post-LVAD implant, they completed PROMIS Ability to Participate in Social Roles and Activities, Satisfaction with Social Roles and Activities, and Physical Function; and Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Social and Physical Limitation measures. PROMIS is standardized to a general population (mean=50; SD=10). KCCQ-12 range is 0-100. Higher scores represent better outcomes. Construct validity was evaluated by Pearson correlations between PROMIS and KCCQ-12 scores. Known-groups validity was evaluated by analysis of variance to distinguish PROMIS means across NYHA and self-reported financial difficulties. Results Mean age was 58 years; 80% were male, 70% were Non-Hispanic White, 79% had financial difficulties due to condition/treatment, and 61% were NYHA I-II. Similar numbers enrolled at 3, 6, 12-26, and > 26 months post-implant. Mean scores for PROMIS and KCCQ-12 measures decreased (worsened) as NYHA worsened (p Conclusion PROMIS measures of social and physical function were associated with well-accepted measures commonly assessed in HF and post-LVAD. Unlike condition-specific measures, PROMIS scores can be compared to the general population or other clinical conditions, thus providing a useful way to interpret social and physical function after LVAD implant.

Purpose Patients with an LVAD face unique burdens in LVAD self-care (device management) in addition to heart failure (HF) self-care (diet, exercise, medications). We evaluated the impact of health literacy and social support on self-efficacy regarding self-care, and evaluated change in self-efficacy. Methods Patients at 9 centers enrolled in the study within 30 days prior to LVAD implantation. Assessments were at baseline and 3 and 6 months post-LVAD. Self-efficacy regarding HF self-care (13 items) and Self-efficacy regarding VAD self-care (12 items) used a 4-point scale: 1=not sure at all, 4=very sure of performing self-care activities. Health Literacy Assessment Using Talking Touchscreen Technology (10 items) was dichotomized as inadequate/low vs. adequate/high. Social support (emotional, instrumental, informational) was measured with PROMIS v2.0 (T-score of 50=general population mean). Participants who died, were transplanted, or were withdrawn before 6 months were excluded from analysis. Linear mixed effects models were estimated using all available longitudinal data, assuming a missing at random mechanism. Results The sample (n=126) was primarily male (72%), non-Hispanic White (62%) and had high health literacy (67%); mean (SD) age was 55 (11.7) years. Excluded participants (n=68) were similar on most variables (p>0.05). Emotional, instrumental and informational social support were substantially higher than the general population (mean (SD): 58 (7.6), 61 (6.4), 59 (8.7)) and positively associated with HF self-care efficacy and LVAD self-care efficacy (parameter estimates: 0.01-0.02; p 0.05). Self-efficacy regarding HF self-care and VAD self-care were high and did not change over time (p>0.05): least-squares means (adjusted for social support and health literacy) at all assessments were 3.7 to 3.9. Conclusion Social support was high and positively associated with higher self-efficacy regarding HF and VAD self-care. Strong social support might mitigate the impact of other risk factors, including low health literacy, on self-efficacy. More research is needed to understand these factors in a more diverse patient group.

Purpose Patients (pts) with advanced heart failure (HF) describe debilitating HF-related symptoms. Those who undergo left ventricular assist device (LVAD) implantation report new surgical and device-related symptoms. We sought to quantify change in both HF and LVAD-related symptoms over time. Methods Using a longitudinal design, we evaluated data at baseline, 3, and 6 months (mos) post implant at 9 U.S. sites from 10/26/16 - 9/9/19. Measures assessed HF symptoms: fatigue (PROMIS, v1.0), dyspnea (10-item short form), swelling in extremities, abdominal bloating, poor appetite (single items), and LVAD-related symptoms: severity of pain at driveline exit site and chest incision, severity of discomfort wearing LVAD peripherals, and frequency of dizziness and fluid leaking around driveline exit site (single items). Linear mixed effects models were estimated using all available longitudinal data, assuming a missing at random mechanism. Results Pts (n=126) were primarily male (72%) and non-Hispanic White (62%), with mean age= 55±11.7 years. HF symptoms (i.e., fatigue, dyspnea, extremity swelling, abdominal bloating, and poor appetite) decreased from before to after implant (table). From 3-6 months after LVAD implant, severity of driveline exit site pain was none-mild and did not change; severity of chest incision pain was mild and decreased from 3 to 6 months; discomfort wearing peripherals was mild-moderate with no change, dizziness occurred rarely to occasionally and did not change, and fluid leaking at the driveline exit site occurred never to rarely and did not change (table). Conclusion Using novel measures, pts with advanced HF experienced considerable improvement of HF symptoms after LVAD implant. However, pts also reported mild/moderate discomfort wearing LVAD-related peripherals, which did not change over time. Other LVAD-related symptoms were less frequent or no more than mild in severity. These findings provide important information for pt decision making and should guide device design.

Introduction Social health (i.e., ability and satisfaction with ability to participate in family, work, and leisure activities) among patients (pts) with advanced heart failure (HF) who undergo left ventricular assist device (LVAD) implantation is incompletely described. This report evaluated social health across three time periods (early, mid, and later) after implantation. Methods We evaluated data from 183 pts with LVADs who were ≤6 months, >6-24 months, and >24 months post-implant at 9 U.S. sites (10/26/16 - 12/31/18). Measures of social health included overall social health and satisfaction with social function (PROMIS v1.1) and multi-item measures of social function and satisfaction with social function (PROMIS v2.0). Tests for differences between implant groups included χ2 tests and ANOVAs. Results Pts at all 3 time periods were, on average, middle-aged; the majority were male, white, and well educated. Etiology of HF and pre-implant strategy were similar among groups. The majority of pts at all 3 time periods reported good to excellent overall ability to carry out usual social activities and roles, and satisfaction with social activities and relationships. Approximately 20% to 30% of patients in all 3 groups reported fair or poor overall social function/ability, and fair or poor satisfaction with social activities and relationships. For all 3 groups, ability to participate in social roles and activities, and satisfaction with social roles and activities approximated the U.S. general population mean of 50. Conclusions Regardless of time since implant, the majority of LVAD pts were able to participate in social activities and were satisfied with their social health. For the subset of patients who reported lower social functioning and satisfaction, future work should focus on developing effective interventions. These findings highlight the importance of assessing social health after LVAD implantation.

Purpose Physical health among patients (pts) with advanced heart failure (HF) who undergo continuous flow left ventricular assist device (CF-LVAD) implantation is incompletely described, especially long-term. Research is needed to identify pts at risk. This report compared physical health early (≤ 6 months), mid (>6-24 months), and later (> 24 months) after CF-LVAD implantation. Methods Using a cross-sectional design, we evaluated data from 250 pts with CF-LVADs who were ≥ 3 months post implant at 9 U.S. sites from 10/26/16 - 06/28/18. Measures of physical health included overall physical health (PROMIS, v1.1), physical function (PROMIS, v1.2), sleep disturbance (PROMIS, v1.0), sleep-related impairment (PROMIS, v1.0), and satisfaction with sexual function (PROMIS, v2.0, modified). Analyses included χ2 tests and ANOVAs. Results The majority of pts were male, white, and well educated; age differed by time period post implant. Etiology of HF and pre implant strategy were similar among groups. The majority of pts in all 3 groups reported fair to good overall physical health, although significant differences were detected by group. For all 3 groups, sleep disturbance and sleep-related impairment scores approximated the U.S. general population mean of 50, while physical function scores were about one standard deviation lower. A majority of pts in all groups were not satisfied with sexual function, and most reported that LVAD equipment affected their satisfaction adversely. See table. Conclusion Regardless of time since implant, while the majority of pts reported overall physical health as fair or good, self-reported physical function was lower than the U.S. population and LVAD equipment interfered with satisfaction with sexual function. These findings highlight the importance of assessing multiple indicators of physical health and may provide direction for physical health focused therapies after CF-LVAD implantation.

Background— Self-care training can reduce hospitalization for heart failure (HF), and more intensive intervention may benefit more vulnerable patients, including those with low literacy. Methods and Results— A 1-year, multisite, randomized, controlled comparative effectiveness trial with 605 patients with HF was conducted. Those randomized to a single session received a 40-minute in-person, literacy-sensitive training; the multisession group received the same initial training and then ongoing telephone-based support. The primary outcome was combined incidence of all-cause hospitalization or death; secondary outcomes included HF-related hospitalization and HF-related quality of life, with prespecified stratification by literacy. Overall, the incidence of all-cause hospitalization and death did not differ between intervention groups (incidence rate ratio, 1.01; 95% confidence interval, 0.83–1.22). The effect of multisession training compared with single-session training differed by literacy group: Among those with low literacy, the multisession training yielded a lower incidence of all-cause hospitalization and death (incidence rate ratio, 0.75; 95% confidence interval, 0.45–1.25), and among those with higher literacy, the multisession intervention yielded a higher incidence (incidence rate ratio, 1.22; 95% confidence interval, 0.99–1.50; interaction P =0.048). For HF-related hospitalization, among those with low literacy, multisession training yielded a lower incidence (incidence rate ratio, 0.53; 95% confidence interval, 0.25–1.12), and among those with higher literacy, it yielded a higher incidence (incidence rate ratio, 1.32; 95% confidence interval, 0.92–1.88; interaction P =0.005). HF-related quality of life improved more for patients receiving multisession than for those receiving single-session interventions at 1 and 6 months, but the difference at 12 months was smaller. Effects on HF-related quality of life did not differ by literacy. Conclusions— Overall, an intensive multisession intervention did not change clinical outcomes compared with a single-session intervention. People with low literacy appear to benefit more from multisession interventions than people with higher literacy. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00378950.

BACKGROUND We sought to examine the relationship between literacy and heart failure-related quality of life (HFQOL), and to explore whether literacy-related differences in knowledge, self-efficacy and/or self-care behavior explained the relationship. METHODS We recruited patients with symptomatic heart failure (HF) from four academic medical centers. Patients completed the short version of the Test of Functional Health Literacy in Adults (TOFHLA) and questions on HF-related knowledge, HF-related self-efficacy, and self-care behaviors. We assessed HFQOL with the Heart Failure Symptom Scale (HFSS) (range 0–100), with higher scores denoting better quality of life. We used bivariate (t-tests and chi-square) and multivariate linear regression analyses to estimate the associations between literacy and HF knowledge, self-efficacy, self-care behaviors, and HFQOL, controlling for demographic characteristics. Structural equation modeling was conducted to assess whether general HF knowledge, salt knowledge, self-care behaviors, and self-efficacy mediated the relationship between literacy and HFQOL. RESULTS We enrolled 605 patients with mean age of 60.7 years; 52% were male; 38% were African-American and 16% Latino; 26% had less than a high school education; and 67% had annual incomes under $25,000. Overall, 37% had low literacy (marginal or inadequate on TOFHLA). Patients with adequate literacy had higher general HF knowledge than those with low literacy (mean 6.6 vs. 5.5, adjusted difference 0.63, p

Objectives This study was designed to determine the association between race and atrial fibrillation (AF) among patients with heart failure (HF). Background Atrial fibrillation is known to complicate HF, but whether its prevalence varies by race, and the reasons why, are not well understood. Methods We identified adults hospitalized with confirmed HF within a large integrated healthcare delivery system. We obtained information on demographics, comorbidity, vital signs, medications, and left ventricular systolic function status. “Atrial fibrillation” was defined as AF or atrial flutter documented by electrocardiogram or prior physician-assigned diagnoses. We evaluated the independent relationship between race and AF using multivariable logistic regression. Results Among 1,373 HF patients (223 African Americans, 1,150 Caucasians), the prevalence of AF was 36.9% (95% confidence interval [CI] 34.3% to 39.5%). Compared with Caucasians, African Americans were younger (mean age 67 vs. 74 years, p Conclusions In a contemporary HF cohort, AF was significantly less common among African Americans than among Caucasians. This variation was not explained by differences in traditional risk factors for AF, HF etiology and severity, and treatment.

Aims and objectivesTo determine whether a single-item self-report medication adherence question predicts hospitalisation and death in patients with heart failure.BackgroundPoor medication adherence is associated with increased morbidity and mortality. Having a simple means of identifying suboptimal medication adherence could help identify at-risk patients for interventions.DesignWe performed a prospective cohort study in 592 participants with heart failure within a four-site randomised trial.MethodsSelf-report medication adherence was assessed at baseline using a single-item question: 'Over the past seven days, how many times did you miss a dose of any of your heart medication?' Participants who reported no missing doses were defined as fully adherent, and those missing more than one dose were considered less than fully adherent. The primary outcome was combined all-cause hospitalisation or death over one year and the secondary endpoint was heart failure hospitalisation. Outcomes were assessed with blinded chart reviews, and heart failure outcomes were determined by a blinded adjudication committee. We used negative binomial regression to examine the relationship between medication adherence and outcomes.ResultsFifty-two percent of participants were 52% male, mean age was 61years, and 31% were of New York Heart Association class III/IV at enrolment; 72% of participants reported full adherence to their heart medicine at baseline. Participants with full medication adherence had a lower rate of all-cause hospitalisation and death (0·71events/year) compared with those with any nonadherence (0·86events/year): adjusted-for-site incidence rate ratio was 0·83, fully adjusted incidence rate ratio 0·68. Incidence rate ratios were similar for heart failure hospitalisations.ConclusionA single medication adherence question at baseline predicts hospitalisation and death over one year in heart failure patients.Relevance to clinical practiceMedication adherence is associated with all-cause and heart failure-related hospitalisation and death in heart failure. It is important for clinicians to assess patients' medication adherence on a regular basis at their clinical follow-ups.

BackgroundLow literacy increases the risk for many adverse health outcomes, but the relationship between literacy and adverse outcomes in heart failure (HF) has not been well studied.MethodsWe studied a cohort of ambulatory patients with symptomatic HF (NYHA Class II-IV within the past 6months) who were enrolled in a randomized controlled trial of self-care training recruited from internal medicine and cardiology clinics at four academic medical centers in the US. The primary outcome was combined all-cause hospitalization or death, with a secondary outcome of hospitalization for HF. Outcomes were assessed through blinded interviews and subsequent chart reviews, with adjudication of cause by a panel of masked assessors. Literacy was measured using the short Test of Functional Health Literacy in Adults. We used negative binomial regression to examine whether the incidence of the primary and secondary outcomes differed according to literacy.ResultsOf the 595 study participants, 37% had low literacy. Mean age was 61, 31% were NYHA class III/IV at baseline, 16% were Latino, and 38% were African-American. Those with low literacy were older, had a higher NYHA class, and were more likely to be Latino (all p

Self-management is vital for achieving optimal health outcomes for patients with heart failure (HF). We sought to develop an intervention to improve self-management skills and behaviors for patients with HF, especially those with low health literacy. Individuals with low health literacy have difficulty reading and understanding written information and comprehending numerical information and performing calculations, and they tend to have worse baseline knowledge, short-term memory, and working memory compared to individuals with higher health literacy. This paper describes theoretical models that suggest methods to improve the design of educational curricula and programs for low literate audiences, including cognitive load theory and learning mastery theory. We also outline the practical guiding principles for designing our intervention, which includes a multi-session educational strategy that teaches patients self-care skills until they reach behavioral goals (“Teach to Goal”). Ourintervention strategy is being tested in a randomized controlled trial to determine if it is superior to a single-session brief educational intervention for reducing hospitalization and death. If this trial shows that the “Teach to Goal” approach is superior, this would support the value of incorporating these design principles into educational interventions for other diseases.

The optimal strategy for promoting self-care for heart failure (HF) is unclear.We conducted a randomized trial to determine whether a "teach to goal" (TTG) educational and behavioral support program provided incremental benefits to a brief (1 hour) educational intervention (BEI) for knowledge, self-care behaviors, and HF-related quality of life (HFQOL). The TTG program taught use of adjusted-dose diuretics and then reinforced learning goals and behaviors with 5 to 8 telephone counseling sessions over 1 month. Participants' (n = 605) mean age was 61 years; 37% had marginal or inadequate literacy; 69% had ejection fraction0.45; and 31% had Class III or IV symptoms. The TTG group had greater improvements in general and salt knowledge (P.001) and greater increases in self-care behaviors (from mean 4.8 to 7.6 for TTG vs. 5.2 to 6.7 for BEI; P.001). HFQOL improved from 58.5 to 64.6 for the TTG group but did not change for the BEI group (64.7 to 63.9; P.001 for the difference in change scores). Improvements were similar regardless of participants' literacy level.Telephone reinforcement of learning goals and self-care behaviors improved knowledge, health behaviors, and HF-related QOL compared to a single education session.

Dyspnea is a common symptom among patients with heart failure. Currently, there is no standardized, rapid, precise method to assess dyspnea.From a review of the literature, we pooled questions from various questionnaires assessing dyspnea. A total of 201 patients with heart failure completed all questions in the preliminary item bank. Each item asks how much shortness of breath the patient had when doing an activity. Medical charts were reviewed for hospitalization within 1 or 3 months of completing the questions. We created a dyspnea item bank of 44 items. Computer adaptive tests (CAT) generated from this item bank can assess dyspnea by administering on average 10 questions. Simulation CAT scores were generated to compare with the item bank scores. The CAT scores had a correlation of 0.98 with item bank scores. Logistic regression models predicting the probability of being hospitalized from the dyspnea score were statistically significant (P.05). A 5-point score increase was associated with a 32% increased odds of hospitalization in 1 month and a 20% increased odds of hospitalization in 3 months.This computer-based tool for dyspnea assessment obtains similar precision to that of answering the entire dyspnea item bank with less patient burden.

Background Heart failure (HF) is common, costly and associated with significant morbidity and poor quality of life, particularly for patients with low socioeconomic status. Self-management training has been shown to reduce HF related morbidity and hospitalization rates, but there is uncertainty about how best to deliver such training and what patients benefit. This study compares a single session self-management HF training program against a multiple session training intervention and examines whether their effects differ by literacy level. Methods/Design In this randomized controlled multi-site trial, English and Spanish-speaking patients are recruited from university-affiliated General Internal Medicine and Cardiology clinics at 4 sites across the United States. Eligible patients have HF with New York Heart Association class II-IV symptoms and are prescribed a loop diuretic. Baseline data, including literacy level, are collected at enrollment and follow-up surveys are conducted at 1, 6 and 12 months Upon enrollment, both the control and intervention groups receive the same 40 minute, literacy-sensitive, in-person, HF education session covering the 4 key self-management components of daily self assessment and having a plan, salt avoidance, exercise, and medication adherence. All participants also receive a literacy-sensitive workbook and a digital bathroom scale. After the baseline education was completed, patients are randomly allocated to return to usual care or to receive ongoing education and training. The intervention group receives an additional 20 minutes of education on weight and symptom-based diuretic self-adjustment, as well as periodic follow-up phone calls from the educator over the course of 1 year. These phone calls are designed to reinforce the education, assess participant knowledge of the education and address barriers to success. The primary outcome is the combined incidence of all cause hospitalization and death. Secondary outcomes include HF-related quality of life, HF-related hospitalizations, knowledge regarding HF, self-care behavior, and self-efficacy. The effects of each intervention will be stratified by patient literacy, in order to identify any differential effects. Discussion Enrollment of the proposed 660 subjects will continue through the end of 2009. Outcome assessments are projected to be completed by early 2011. Trial Registration ClinicalTrials.gov http://www.clinicaltrials.gov/ NCT00378950

This study was designed to determine the association between race and atrial fibrillation (AF) among patients with heart failure (HF).Atrial fibrillation is known to complicate HF, but whether its prevalence varies by race, and the reasons why, are not well understood.We identified adults hospitalized with confirmed HF within a large integrated healthcare delivery system. We obtained information on demographics, comorbidity, vital signs, medications, and left ventricular systolic function status. "Atrial fibrillation" was defined as AF or atrial flutter documented by electrocardiogram or prior physician-assigned diagnoses. We evaluated the independent relationship between race and AF using multivariable logistic regression.Among 1,373 HF patients (223 African Americans, 1,150 Caucasians), the prevalence of AF was 36.9% (95% confidence interval [CI] 34.3% to 39.5%). Compared with Caucasians, African Americans were younger (mean age 67 vs. 74 years, p0.001) and more likely to have hypertension (86.6% vs. 77.7%, p0.01) and prior diagnosed HF (79.4% vs. 70.7%, p0.01). African Americans had less prior diagnosed coronary disease, revascularization, hypothyroidism, or valve replacement. Atrial fibrillation was much less prevalent in African Americans (19.7%) than Caucasians (38.3%, p0.001). After adjustment for risk factors for AF and other potential confounders, African Americans had 49% lower odds of AF (adjusted odds ratio 0.51, 95% CI 0.35 to 0.76).In a contemporary HF cohort, AF was significantly less common among African Americans than among Caucasians. This variation was not explained by differences in traditional risk factors for AF, HF etiology and severity, and treatment.

Background Weight monitoring is an important element of HF self-care, yet the most clinically meaningful way to evaluate weight monitoring adherence is uncertain. We conducted this study to evaluate the association of (1) self-reported recall and (2) daily diary-recorded weight monitoring adherence with heart failure-related (HF-related) hospitalization. Methods We conducted a prospective cohort study among 216 patients within a randomized trial of HF self-care training. All patients had an initial self-care training session followed by 15 calls (median) to reinforce educational material; patients were also given digital scales, instructed to weigh daily, record weights in a diary, and mail diaries back monthly. Weight monitoring adherence was assessed with a self-reported recall question administered at 12 months and dichotomized into at least daily versus less frequent weighing. Diary-recorded weight monitoring was evaluated over 12 months and dichotomized into ≥80% and

Background The Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation study demonstrated that implantable cardioverter defibrillators (ICDs) significantly reduce the risk of sudden cardiac death in patients with nonischemic cardiomyopathy and an ejection fraction of 35% or less, with no statistically significant decrease in overall mortality. The impact of ICD placement and shock on health-related quality of life (HRQL) in this population is unknown. Methods The 12-Item Medical Outcomes Short-Form Health Survey and the Minnesota Living with Heart Failure Questionnaire were administered to 458 patients with nonischemic cardiomyopathy, an ejection fraction of 35% or less, and either nonsustained ventricular tachycardia or 10 or more premature ventricular depolarizations per hour at baseline, 1 month after randomization, and every 3 months thereafter throughout the trial. The subjects were randomized to an ICD or standard medical therapy. Outcomes were compared using hierarchical linear regression. Results Overall, there were no significant differences in HRQL throughout the trial between patients randomized to an ICD or standard medical therapy. However, in patients with 1 or more ICD shocks, HRQL declined 0.5 ± 0.2 (mean ± SD) points per shock on the emotional scale of the Minnesota Living with Heart Failure Questionnaire ( P = .04) and 1.0 ± 0.5 points per shock on the mental component score of the 12-Item Medical Outcomes Short-Form Health Survey ( P = .04). Conclusions Overall, HRQL was not affected by ICD implantation in patients in the Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation study. Implantable cardioverter defibrillator shock was associated with a reduction in some measures of HRQL, but the effects were unlikely to result in a clinically observable alteration until 5 or more shocks were experienced.