Efficient measurement of multiple ventricular assist device patient-reported outcomes: Creation of a 20-item profile from the MCS A-QOL study.

BACKGROUND: Patient-reported outcome (PRO) measures of distinct concepts are often put together into patient profile assessments. When brief, profile assessments can decrease respondent burden and increase measure completion rates. In this report, we describe the creation of 5 self-reported 4-item short forms and the Mechanical Circulatory Support: Measures of Adjustment and Quality of Life (MCS A-QOL) 20-item profile to assess PROs specific to adjustment and health-related quality of life (HRQOL) among patients who undergo left ventricular assist device (LVAD) implantation. METHODS: Using a cross-sectional sample of patients (n = 620) who underwent LVAD implantation at 12 U.S. sites or participated in the MyLVAD.com support group, we created 5 4-item short forms: Satisfaction with Treatment, ventricular assist device (VAD) Team Communication, Being Bothered by VAD Self-care and Limitations, Self-efficacy Regarding VAD self-care, and Stigma, which we combined into a 20-item profile. Analyses included intercorrelations among measures, Cronbach's alpha (i.e., internal consistency reliability)/score-level-specific reliability, and construct validity. RESULTS: The 620 patients were mean age = 57 years, 78% male, 70% White, and 56% on destination therapy LVADs. Intercorrelations among the 5 4-item measures were low to moderate (≤0.50), indicating they are associated yet largely distinct, and correlations with calibrated measures and 6-item short forms were ≥0.76, indicating their ability to reflect full-item bank scores. Internal consistency reliability for the 5 4-item short forms ranged from acceptable (≥0.70) to good (≥0.80). Construct validity was demonstrated for these measures. CONCLUSIONS: Our 5 4-item short forms are reliable and valid and may be used individually or together as a 20-item profile to assess adjustment and HRQOL in patients who undergo LVAD implantation.

A comparison of quality-adjusted life years in older adults after heart transplantation versus long-term mechanical support: Findings from the SUSTAIN-IT study.

BACKGROUND: The quality-adjusted life year (QALY) measures disease burden and treatment, combining overall survival and health-related quality of life (HRQOL). We estimated QALYs in 3 groups of older patients (60-80 years) with heart failure (HF) who underwent heart transplantation (HT, with pre-transplant mechanical circulatory support [HT MCS] or HT without pre-transplant MCS [HT Non-MCS]) or long-term MCS (destination therapy). We also identified factors associated with gains in QALYs through 24 months follow-up. METHODS: Of 393 eligible patients enrolled (10/1/15-12/31/18) at 13 U.S. sites, 161 underwent HT (n = 68 HT MCS, n = 93 HT Non-MCS) and 144 underwent long-term MCS. Survival and HRQOL data were collected through 24 months. QALY health utilities were based on patient self-report of EQ-5D-3L dimensions. Mean-restricted QALYs were compared among groups using generalized linear models. RESULTS: For the entire cohort, mean age in years closest to surgery was 67 (standard deviation, SD: 4.7), 78% were male, and 83% were White. By 18 months post-surgery, sustained significant differences in adjusted average ± SD QALYs emerged across groups, with the HT Non-MCS group having the highest average QALYs (24-month window: HT Non-MCS = 22.58 ± 1.1, HT MCS = 19.53 ± 1.33, Long-term MCS = 19.49 ± 1.3, p = 0.003). At 24 months post-operatively, a lower gain in QALYs was associated with HT MCS, long-term MCS, a lower pre-operative LVEF, NYHA class III or IV before surgery, and an ischemic or other etiology of HF. CONCLUSIONS: Determination of QALYs may provide important information for policy makers and clinicians to consider regarding benefits of HT and long-term MCS as treatment options for older patients with HF.

Peak insulin drip rate associated with decreased infections post-solid organ transplant.

Infection and rejection outcomes were retrospectively analyzed in patients following liver transplant and separately following heart transplant with patients being stratified by their severity of immediate postoperative insulin resistance as measured by the peak insulin drip rate that was required to reduce glucose levels. For each group, these peak insulin drip rates were divided into quartiles (Q). In liver transplant patients (n = 207), those in Q4 (highest infusion rate) had significantly fewer infections up to 6 months post-transplant (42.3% vs. 60.0%, p = .036) and borderline fewer rejection episodes (25.0% vs. 40.0%, p = .066) compared to Q1-Q3 patients. To confirm these unexpected results, a subsequent similar analysis in heart transplant (n = 188) patients again showed that Q4 patients had significantly fewer infections up to 6 months (19.1% vs. 53.9%, p < .0001) compared to Q1-Q3 patients. Logistic regression in a subset of 103 cardiac transplant patients showed that the maximum glucose during surgery, prior MI, and hypertension were associated with severe insulin resistance (SIR) status, while the presence of pre-existing diabetes and BMI were not. We hypothesize that patients are who are able to mount a more robust counter-regulatory response that causes the insulin resistance may be healthier and thus able to mount a better response to infections.

Promoting maternal-child health by increasing breastfeeding rates: a National Canadian Baby-Friendly Initiative Quality Improvement Collaborative Project.

While breastfeeding has long been an important, globally recognized aspect of population health, disparities exist across Canada. The Baby-Friendly Initiative (BFI) is a WHO/UNICEF best-practice program that helps ensure families receive evidence-based perinatal care and is associated with improved breastfeeding rates. However, <10% of hospitals in Canada are designated as 'Baby-Friendly'.The Breastfeeding Committee for Canada (BCC) aimed to increase the number of hospitals that moved towards BFI designation by implementing a National BFI Quality Improvement Collaborative Project. Key activities included (1) implementing and evaluating the BFI Project with 25 hospital teams across Canada and (2) making recommendations for scaling up BFI in Canada.As of December 2023, three hospitals in the BFI Project have attained designation and six have started the official process towards designation with the BCC. Breastfeeding initiation rates remained high and stable (>80%); however, breastfeeding exclusivity rates did not meet targets. All BFI care indicators improved across participating facilities. All skin-to-skin indicators improved, with rates of immediate and sustained skin-to-skin meeting targets of >80% for vaginal births. BFI care indicators of documented assistance and support with breastfeeding within 6 hours of birth, rooming-in and education about community supports also met target levels. Leadership buy-in, parent partner engagement and collaborative activities of workshops, webinars and mentoring with BFI Project leadership were viewed as valuable.This BFI Project demonstrated that hospitals could successfully implement Baby-Friendly practices in various Canadian settings despite challenges introduced by the COVID-19 pandemic. Indicators collected as part of this work demonstrate that delivery of Baby-Friendly care improved in participating facilities. Sustainability and scaling up BFI implementation in both hospitals and community health services across Canada through implementation of a BFI Coach Mentor Program is ongoing to enable continued progress and impact on breastfeeding and maternal-child health.

Novel measures to assess ventricular assist device patient-reported outcomes: Findings from the MCS A-QOL study.

BACKGROUND: Generic and heart failure-specific measures do not capture unique aspects of living with a ventricular assist device (VAD). Using state-of-the-science psychometric measurement methods, we developed a measurement system to assess post-ventricular assist device adjustment and health-related quality of life (HRQOL). METHODS: Patients were recruited from 10/26/16-2/29/20 from 12 U.S. VAD programs. We created a dataset of participants (n = 620) enrolled before left (L)VAD implantation, with data at 3- or 6- months post-implantation (group1 [n = 154]), and participants enrolled after LVAD implantation, with data at one timepoint (group 2 [n = 466]). We constructed 5 item banks: 3 modified from existing measures and 2 new measures. Analyses included item response theory (IRT) modeling, differential item functioning tests for systematic measurement bias, and indicators of reliability and validity. RESULTS: Of 620 participants, 56% (n = 345) were implanted as destination therapy, 51% (n = 316) were <12 months post-implantation, mean age = 57.3 years, 78% (n = 485) male, 70% (n = 433) White, 58% (n = 353) married/partnered, and 58% (n = 357) with >high school education. We developed 5 new VAD item banks/measures: 6-item VAD Team Communication; 12-item Self-efficacy Regarding VAD Self-care; 11-item Being Bothered by VAD Self-care and Limitations; 7-item Satisfaction with Treatment; and 11-item Stigma. Cronbach's alpha reliability ranged from good (≥0.80) to excellent (≥0.90) for item banks/measures. All measures, except VAD Team Communication, demonstrated at least moderate correlations (≥0.30) with construct validity indicators. CONCLUSIONS: These measures meet IRT modeling assumptions and requirements; scores demonstrate reliability and validity. Use of these measures may assist VAD clinicians to inform patients about VADs as a treatment option and guide post-VAD interventions.

Health Status in Heart Failure and Cancer: Analysis of the Medicare Health Outcomes Survey 2016-2020.

BACKGROUND: People with heart failure (HF) and cancer experience impaired physical and mental health status. However, health-related quality of life (HRQOL) has not been directly compared between these conditions in a contemporary population of older people. OBJECTIVES: The authors sought to compare HRQOL in people with HF vs those with lung, colorectal, breast, and prostate cancers. METHODS: The authors performed a pooled analysis of Medicare Health Outcomes Survey data from 2016 to 2020 in participants ≥65 years of age with a self-reported history of HF or active treatment for lung, colon, breast, or prostate cancer. They used the Veterans RAND-12 physical component score (PCS) and mental component score (MCS), which range from 0-100 with a mean score of 50 (based on the U.S. general population) and an SD of 10. The authors used pairwise Student's t-tests to evaluate for differences in PCS and MCS between groups. RESULTS: Among participants with HF (n = 71,025; 54% female, 16% Black), mean PCS was 29.5 and mean MCS 47.9. Mean PCS was lower in people with HF compared with lung (31.2; n = 4,165), colorectal (35.6; n = 4,270), breast (37.7; n = 14,542), and prostate (39.6; n = 17,670) cancer (all P < 0.001). Participants with HF had a significantly lower mean MCS than those with lung (31.2), colon (50.0), breast (52.0), and prostate (53.0) cancer (all P < 0.001). CONCLUSIONS: People with HF experience worse HRQOL than those with cancer actively receiving treatment. The pervasiveness of low HRQOL in HF underscores the need to implement evidence-based interventions that target physical and mental health status and scale multidisciplinary clinics.

Change in Caregiver Health-Related Quality of Life From Before to Early After Surgery: SUSTAIN-IT Study.

BACKGROUND: Information about health-related quality of life (HRQOL) among caregivers of older patients with heart failure who receive heart transplantation (HT) and mechanical circulatory support (MCS) is sparse. We describe differences and factors associated with change in HRQOL before and early post-surgery among caregivers of older heart failure patients who underwent 3 surgical therapies: HT with pretransplant MCS (HT MCS), HT without pretransplant MCS (HT non-MCS), and long-term MCS. METHODS: Caregivers of older patients (60-80 years) from 13 US sites completed the EQ-5D-3 L visual analog scale (0 [worst]-100 [best] imaginable health state) and dimensions before and 3 and 6 months post-surgery. Analyses included linear regression, t tests, and nonparametric tests. RESULTS: Among 227 caregivers (HT MCS=54, HT non-MCS=76, long-term MCS=97; median age 62.7 years, 30% male, 84% White, 83% spouse/partner), EQ-5D visual analog scale scores were high before (84.8±14.1) and at 3 (84.7±13.0) and 6 (83.9±14.7) months post-surgery, without significant differences among groups or changes over time. Patient pulmonary hypertension presurgery (ß=-13.72 [95% CI, -21.07 to -6.36]; P<0.001) and arrhythmia from 3 to 6 months post-operatively (ß=-14.22 [95% CI, -27.41 to -1.02]; P=0.035) were associated with the largest decrements in caregiver HRQOL; patient marital/partner status (ß=6.21 [95% CI, 1.34-11.08]; P=0.013) and presurgery coronary disease (ß=8.98 [95% CI, 4.07-13.89]; P<0.001) were associated with the largest improvements. CONCLUSIONS: Caregivers of older patients undergoing heart failure surgeries reported overall high HRQOL before and early post-surgery. Understanding factors associated with caregiver HRQOL may inform decision-making and support needs. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02568930.

Infections following left ventricular assist device implantation and 1-year health-related quality of life.

BACKGROUND: Left ventricular assist device (LVAD) implantation leads to substantial and sustained improvement in health-related quality of life (HRQOL) among patients. Infection following device implantation remains an important and frequent complication and adversely affects patient-reported HRQOL. METHODS: Patients in The Society of Thoracic Surgeons' Interagency Registry for Mechanically Assisted Circulatory Support receiving a primary LVAD between April 2012 to October 2016 were included. The primary exposure was one-year post-implant infection, characterized by: (1) any infection; (2) total number of infections and (3) type (LVAD-specific, LVAD-related, non-LVAD). The association between infection and the primary composite adverse outcome (defined as EuroQoL Visual Analog Scale< 65, too sick to complete the survey, or death at 1-year) was estimated using inverse probability weighting and Cox regression. RESULTS: The study cohort included 11,618 patients from 161 medical centers with 4,768 (41.0%) patients developing an infection, and 2,282 (19.6%) patients having> 1 infection during the follow up period. The adjusted odds ratio for the primary composite adverse outcome was 1.22 (95% CI, 1.19-1.24, p < 0.001) for each additional infection. Each additional infection was associated with a 3.49% greater probability of the primary composite outcome and was associated with worse performance across multiple dimensions of HRQOL as assessed by the EQ-5D for patients who survived to 1 year. CONCLUSIONS: For patients undergoing LVAD implantation, each additional infection within the first post-implantation year was associated with an incremental negative effect on survival free of impaired HRQOL.

Impact of adverse events on health-related quality of life after left ventricular assist device implantation: An STS INTERMACS analysis.

BACKGROUND: We sought to quantify the impact of pre- and postoperative variables on health-related quality of life (HRQOL) after left ventricular assist device (LVAD) implantation. METHODS: Primary durable LVAD implants between 2012 and 2019 in the Interagency Registry for Mechanically Assisted Circulatory Support were identified. Multivariable modeling using general linear models assessed the impact of baseline characteristics and postimplant adverse events (AEs) on HRQOL as assessed by the EQ-5D visual analog scale (VAS) and the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ) at 6 months and 3 years. RESULTS: Of 22,230 patients, 9,888 had VAS and 10,552 had KCCQ reported at 6 months, and 2,170 patients had VAS and 2,355 had KCCQ reported at 3 years postimplant. VAS improved from a mean of 38.2 ± 28.3 to 70.7 ± 22.9 at 6 months and from 40.1 ± 27.8 to 70.3 ± 23.1 at 3 years. KCCQ improved from 28.2 ± 23.9 to 64.3 ± 23.2 at 6 months and from 29.8 ± 23.7 to 63.0 ± 23.7 at 3 years. Preimplant variables, including baseline VAS, had small effect sizes on HRQOL while postimplant AEs had large negative effect sizes. Recent stroke, respiratory failure, and renal dysfunction had the largest negative effect on HRQOL at 6 months, while recent renal dysfunction, respiratory failure, and infection had the largest negative effect at 3 years. CONCLUSIONS: AEs following LVAD implantation have large negative effects on HRQOL in early and late follow-up. Understanding the impact of AEs on HRQOL may assist shared decision-making regarding LVAD eligibility. Continued efforts to reduce post-LVAD AEs are warranted to improve HRQOL in addition to survival.

PROMIS: Physical, Mental and Social Health Outcomes Improve From Before to Early After LVAD Implant: Findings From the Mechanical Circulatory Support: Measures of Adjustment and Quality of Life (MCS A-QOL) Study.

Study participants (n = 272) completed 12 Patient-Reported Outcomes Measurement Information System (PROMIS) physical, mental and social health measures (questionnaires) prior to implantation of a left ventricular assist device (LVAD) and again at 3 and 6 months postimplant. All but 1 PROMIS measure demonstrated significant improvement from pre-implant to 3 months; there was little change between 3 and 6 months. Because PROMIS measures were developed in the general population, patients with an LVAD, their caregivers and their clinicians can interpret the meaning of PROMIS scores in relation to the general population, helping them to monitor a return to normalcy in everyday life.

Association Between Caregiver Burden and Patient Recovery After Left Ventricular Assist Device Implantation: Insights From Sustaining Quality of Life of the Aged: Heart Transplant or Mechanical Support.

INTRODUCTION: After left ventricular assist device (LVAD) implantation, caregivers may experience increasing burden because of new roles and responsibilities. We examined the association between caregiver burden at baseline and patient recovery after long-term LVAD implantation in patients ineligible for heart transplantation. METHODS: Between October 1, 2015, and December 31, 2018, data from 60 patients with a long-term LVAD (age, 60-80 years) and caregivers through 1 postoperative year were analyzed. Caregiver burden was measured using the Oberst Caregiving Burden Scale, a validated instrument used for measuring caregiver burden. Patient recovery post-LVAD implantation was defined by change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) overall summary score and rehospitalizations over 1 year. Multivariable regression models (least-squares for change in KCCQ-12 and Fine-Gray cumulative incidence for rehospitalizations) were used to assess for association with caregiver burden. RESULTS: Patients were 69.4 ± 5.5 years old, 85% men, and 90% White. Over the first year post-LVAD implantation, there was a 32% cumulative probability of rehospitalization; 72% (43/60) of patients had an improvement of ≥5 points in KCCQ-12 scores. Caregivers were 61.2 ± 11.5 years old, 93% women, 81% White, and 85% married. Median Oberst Caregiving Burden Scale Difficulty and Time scores at baseline were 1.13 and 2.27, respectively. Higher caregiver burden was not significantly associated with hospitalizations or change in patient health-related quality of life during the first year post-LVAD implantation. CONCLUSIONS: Higher caregiver burden at baseline was not associated with patient recovery in the first year after LVAD implantation. Understanding the associations between caregiver burden and patient outcomes after LVAD implantation is important as excessive caregiver burden is a relative contraindication for LVAD implantation.

Caregiver burden before heart transplantation and long-term mechanical circulatory support: Findings from the sustaining quality of life of the aged: Transplant or mechanical support (SUSTAIN-IT) study.

BACKGROUND: Caregiving for heart failure (HF) patients is burdensome. We examined differences in caregiver burden for 3 groups of older advanced HF patients: (1) supported with mechanical circulatory support (MCS) before heart transplantation (HT MCS), (2) awaiting transplant without MCS (HT non-MCS), and (3) prior to long-term MCS and factors associated with burden. METHOD: From October 1, 2015 to December 31, 2018, we enrolled 276 caregivers for HF patients from 13 U.S. sites: 85 HT MCS, 96 HT non-MCS, and 95 prior to long-term MCS. At enrollment, caregivers completed the Oberst Caregiving Burden Scale (15 items, 2 subscales: time (range = 1-5; higher score = more time spent on task) and difficulty (range = 1-5; higher score = higher difficulty of task) and other measures. Statistical analyses included descriptive statistics, ANOVA, chi-square tests, and linear regression. RESULT: Overall, caregivers were aged 60.8 ± 9.8 years and predominantly white, female, spouses, well educated, and reported ≥1 comorbidities. Caregivers overall reported a moderate amount of time spent on tasks and slight task difficulty. Caregivers for HT non-MCS candidates reported significantly less perceived time spent on tasks than caregivers for HT MCS candidates and caregivers for patients prior to long-term MCS (2.2 ± 0.74 vs 2.4 ± 0.74 vs 2.5 ± 0.71, respectively, p = 0.02) and less perceived difficulty of tasks (1.2 ± 0.33 vs 1.4 ± 0.53 vs 1.4 ± 0.54, respectively, p = 0.01). Caregiver and patient factors were associated with caregiver burden. CONCLUSIONS: Prior to HT and long-term MCS, caregiver burden was low to moderate. Caregiver factors were predominantly associated with caregiver burden. Understanding caregiver burden and factors affecting caregiver burden may enhance preoperative advanced therapies discussions and guide caregiver support.

Association of Days Alive and Out of the Hospital After Ventricular Assist Device Implantation With Adverse Events and Quality of Life.

Importance: There is a need to better assess the cumulative effect on morbidity and mortality in patients undergoing durable left ventricular assist device (LVAD) implantation. This study evaluates a patient-centered performance metric (days alive and out of hospital [DAOH]) for durable LVAD therapy. Objective: To determine the incidence of percent of DAOH before and after LVAD implantation and (2) explore its association with established quality metrics (death, adverse events [AEs], quality of life). Design, Settings, and Participants: This was a retrospective national cohort study of Medicare beneficiaries implanted with a durable continuous-flow LVAD between April 2012 and December 2016. The data were analyzed from December 2021 to May 2022. Follow-up was 100% complete at 1 year. Data from The Society of Thoracic Surgeons Intermacs registry were linked to Medicare claims. Main Outcomes and Measures: The number of DAOH 180 days before and 365 days after LVAD implantation and daily patient location (home, index hospital, nonindex hospital, skilled nursing facility, rehabilitation center, hospice) were calculated. Percent of DAOH was indexed to each beneficiary's pre- (percent DAOH-BF) and postimplantation (percentage of DAOH-AF) follow-up time. The cohort was stratified by terciles of percentage of DAOH-AF. Results: Among the 3387 patients included (median [IQR] age: 66.3 [57.9-70.9] years), 80.9% were male, 33.6% and 37.1% were Interfaces Patient Profile 2 and 3, respectively, and 61.1% received implants as destination therapy. Median (IQR) percent of DAOH-BF was 88.8% (82.7%-93.8%) and 84.6% (62.1-91.5%) for percent of DAOH-AF. While DAOH-BF was not associated with post-LVAD outcomes, patients in the low tercile of percentage of DAOH-AF had a longer index hospitalization stay (mean, 44 days; 95% CI, 16-77), were less likely to be discharged home (mean. -46.4 days; 95% CI, 44.2-49.1), and spent more time in a skilled nursing facility (mean, 27 days; 95% CI, 24-29), rehabilitation center (mean, 10 days; 95% CI, 8-12), or hospice (mean, 6 days; 95% CI, 4-8). Increasing percentage of DAOH-AF was associated with patient risk, AEs, and indices of HRQoL. Patients experiencing non-LVAD-related AEs had the lowest percentage of DAOH-AF. Conclusions and Relevance: Significant variability existed in the percentage of DAOH within a 1-year time horizon and was associated with the cumulative AEs burden. This patient-centered measure may assist clinicians in informing patients about expectations after durable LVAD implantation. Validation of percentage DAOH as a quality metric for LVAD therapy across centers should be explored.

Validity of Patient-Reported Outcomes Measurement Information System Physical, Mental, and Social Health Measures After Left Ventricular Assist Device Implantation and Implications for Patient Care.

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<0.01). Most validity analyses demonstrated medium-to-large effect sizes (≥0.5) and clinically important differences in mean PROMIS scores (up to 14.8 points). Ranges of minimally important differences for 4 PROMIS measures were as follows: fatigue (3-5 points), physical function (2-3), ability to participate in social roles and activities (3), and satisfaction with social roles and activities (3-5). 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.

Pan-Canadian caregiver experiences in accessing government disability programs: A mixed methods study.

BACKGROUND: At present, little is known about the factors that contribute to the relatively low uptake of government-funded disability programs in Canada. AIM: Understand how parents/caregivers of Canadian youth with neurodevelopmental disability (NDD) experience the process of applying for and accessing disability programs. METHODS AND PROCEDURES: This mixed methods sequential explanatory study utilized two phases: an online survey (quantitative), followed by semi-structured interviews (qualitative). The quantitative phase gathered sociodemographic information and preliminary information about participant experiences applying for and accessing programs. The qualitative phase provided greater depth by asking participants to describe barriers and facilitators to program access. OUTCOMES AND RESULTS: 499 participants completed the online survey and 81 participants completed an interview. Analysis of survey data revealed that many participants are not accessing disability programs and experience difficulty when applying. Regression analyses revealed that factors relating to the process of applying and applicant/family attributes are significantly associated with program access. Inductive thematic analysis of interview data revealed four barriers and three facilitators to access. Integration of findings provided an overview of the multi-faceted journey to program access. CONCLUSIONS AND IMPLICATIONS: The results of this study highlight policy changes that are needed to ensure disability programs adequately support Canadian families.

Ventricular Assist Device Self-care Education at Tertiary Care Medical Centers.

Ventricular assist device (VAD) implantation requires patients and caregivers to attain self-care knowledge and skills before discharge from implant hospitalization. Inability to perform these skills can have devastating outcomes (i.e., death from pump malfunction, driveline site infections, and stroke). No standard-of-care guiding VAD self-care education exists. We sought to describe how select tertiary care VAD implant centers across the United States currently educate VAD patients and their caregivers. Using a multiple case studies design with a purposive sampling strategy, we conducted semistructured interviews of VAD coordinators responsible for VAD education at 18 centers. From audio recording of interviews, we used rapid qualitative analysis to organize and analyze the data. All centers spent significant time and effort educating patients and caregivers on VAD self-care. Although centers teach similar content, the rigor of assessments and follow-up education differed vastly. Only 3/18 (17%) centers performed competency-based assessments with a skills checklist and minimum passing standard assessing readiness to perform VAD self-care independently. Twelve of 18 (67%) centers provided formal follow-up education to address skills decay, yet wide variation existed in timing and content of education. Due to the diversity among centers regarding VAD self-care education, more prescriptive practice guidelines are needed.

Health-Related Quality of Life in Older Patients With Heart Failure From Before to Early After Advanced Surgical Therapies: Findings From the SUSTAIN-IT Study.

BACKGROUND: Restoring health-related quality of life (HRQOL) is a therapeutic goal for older patients with advanced heart failure. We aimed to describe change in HRQOL in older patients (60-80 years) awaiting heart transplantation (HT) with or without pretransplant mechanical circulatory support (MCS) or scheduled for long-term MCS, if ineligible for HT, from before to 6 months after these surgeries and identify factors associated with change. METHODS: Patients from 13 US sites completed the EuroQol 5-dimension 3L questionnaire and Kansas City Cardiomyopathy Questionnaire-12 at baseline and 3 and 6 months after HT or long-term MCS. Analyses included univariate comparisons and multivariable linear regression. RESULTS: Among 305 participants (cohort mean age=66.2±4.7 years, 78% male, 84% White, 55% New York Heart Association class IV), 161 underwent HT (n=68 with and n=93 without pretransplant MCS), and 144 received long-term MCS. From baseline to 3 months, EuroQol 5-dimension visual analog scale scores improved in HT patients without pretransplant MCS (54.5±24.3 versus 75.9±16.0, P<0.001) and long-term MCS patients (45.7±22.9 versus 66.2± 20.9, P <0.001); while Kansas City Cardiomyopathy Questionnaire-12 overall summary scores improved in all 3 groups (HT without pretransplant MCS: 47.2±20.9 versus 77.4±20.1, P <0.001; long-term MCS: 35.3±20.2 versus 58.6±22.0, P <0.001; and HT with pretransplant MCS: 58.3±23.6 versus 72.1±23.5, P=0.002). No further HRQOL improvement was found from 3 to 6 months. Factors most significantly associated with change in HRQOL, baseline 3 months, were right heart failure and 3-month New York Heart Association class, and 3 to 6 months, were 6-month New York Heart Association class and major bleeding. CONCLUSIONS: In older heart failure patients, HRQOL improved from before to early after HT and long-term MCS. At 6 postoperative months, HRQOL of long-term MCS patients was lower than one or both HT groups. Understanding change in HRQOL from before to early after these surgeries may enhance decision-making and guide patient care. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02568930.

Incompleteness of health-related quality of life assessments before left ventricular assist device implant: A novel quality metric.

BACKGROUND: Improved health-related quality of life (HRQOL) is an important outcome following durable left ventricular assist device (LVAD) implant. However, half of pre-implant HRQOL data are incomplete in The Society of Thoracic Surgeons' Intermacs registry. Pre-implant HRQOL incompleteness may reflect patient status or hospital resources to capture HRQOL data. We hypothesized that pre-implant HRQOL incompleteness predicts 90 day outcomes and serves as a novel quality metric. METHODS: Risk factors for pre-implant HRQOL (EQ-5D-5L visual analog scale; 12-item Kansas City Cardiomyopathy Questionnaire "KCCQ") incompleteness were examined by stepwise logistic modeling. Direct standardization method was used to calculate adjusted incompleteness rates using a mixed effects logistic model. Hospitals were dichotomized as low or high based on median adjusted incompleteness rates. Andersen-Gill models were used to associate pre-implant HRQOL adjusted incompleteness rate with adverse events within 90 day post-implant. RESULTS: The study cohort included 14,063 patients receiving a primary LVAD (4/2012-8/2017). HRQOL incompleteness at high-rate hospitals was more often due to administrative reasons (risk difference, EQ-5D: 10.1%; KCCQ-12: 11.6%) and less likely due to patient reasons (risk difference, EQ-5D: -8.9%; KCCQ-12: -11.4%). A 10% increase in the adjusted pre-implant EQ-5D incompleteness rate was significantly associated with higher risk of infection-related mortality (HR: 1.09), infection (HR: 1.05), and renal dysfunction (HR: 1.03). A 10% increase in the adjusted pre-implant KCCQ-12 incompleteness rate was significantly associated with higher risk of infection (HR: 1.04). CONCLUSIONS: Hospital adjusted pre-implant HRQOL incompleteness was predictive of 90-day post-implant outcomes and may serve as a novel quality metric.

The development and initial validation of the PROMIS®+HF-27 and PROMIS+HF-10 profiles.

AIMS: Heart failure (HF) is a common and morbid condition impacting multiple health domains. We previously reported the development of the PROMIS®-Plus-HF (PROMIS+HF) profile measure, including universal and HF-specific items. To facilitate use, we developed shorter, PROMIS+HF profiles intended for research and clinical use. METHODS AND RESULTS: Candidate items were selected based on psychometric properties and symptom range coverage. HF clinicians (n = 43) rated item importance and clinical actionability. Based on these results, we developed the PROMIS+HF-27 and PROMIS+HF-10 profiles with summary scores (0-100) for overall, physical, mental, and social health. In a cross-sectional sample (n = 600), we measured internal consistency reliability (Cronbach's alpha and Spearman-Brown), test-retest reliability (intraclass coefficient; n = 100), known-groups validity via New York Heart Association (NYHA) class, and convergent validity with Kansas City Cardiomyopathy Questionnaire (KCCQ) scores. In a longitudinal sample (n = 75), we evaluated responsiveness of baseline/follow-up scores by calculating mean differences and Cohen's d and comparing with paired t-tests. Internal consistency was good to excellent (α 0.82-0.94) for all PROMIS+HF-27 scores and acceptable to good (α/Spearman-Brown 0.60-0.85) for PROMIS+HF-10 scores. Test-retest intraclass coefficients were acceptable to excellent (0.75-0.97). Both profiles demonstrated known-groups validity for the overall and physical health summary scores based on NYHA class, and convergent validity for nearly all scores compared with KCCQ scores. In the longitudinal sample, we demonstrated responsiveness for PROMIS+HF-27 and PROMIS+HF-10 overall and physical summary scores. For the PROMIS+HF overall summary scores, a group-based increase of 7.6-8.3 points represented a small to medium change (Cohen's d = 0.40-0.42). For the PROMIS+HF physical summary scores, a group-based increase of 5.0-5.9 points represented a small to medium change (Cohen's d = 0.29-0.35). CONCLUSIONS: The PROMIS+HF-27 and PROMIS+HF-10 profiles demonstrated good psychometric characteristics with evidence of responsiveness for overall and physical health. These new measures can facilitate patient-centred research and clinical care, such as improving care quality through symptom monitoring, facilitating shared decision-making, evaluating quality of care, assessing new interventions, and monitoring during the initiation and titration of guideline-directed medical therapy.