Importance:Therapeutic hypothermia is widely used for neuroprotection following cardiac arrest, but clinical trials have not consistently demonstrated improved neurological outcomes, and the optimal duration of cooling remains uncertain. Objective:To determine the duration of therapeutic hypothermia that maximizes neurological recovery in comatose survivors of out-of-hospital cardiac arrest. Design, Setting, and Participants:Multicenter, randomized, adaptive-allocation clinical trial conducted at 71 hospitals in the US. Adults with out-of-hospital cardiac arrest who remained unconscious, achieved a target temperature less than 34 °C within 4 hours of cardiac arrest, and had a definitive temperature control device started were eligible. Patients were enrolled between June 2020 and June 2025. Interventions:Therapeutic hypothermia at 33 °C with adaptive randomized allocation to cooling durations of 6, 12, 18, 24, 30, 36, 42, 48, 60, and 72 hours. The first 200 patients were randomized to 12-, 24-, and 48-hour durations in a 1:1:1 ratio. Subsequently, a response-adaptive randomization algorithm allocated preferentially to the groups most likely to be optimal and to best inform the duration-response curve separately within each rhythm type. Main Outcomes and Measures:The primary outcome was neurological function at 90 days, measured using a weighted modified Rankin Scale score, analyzed using a bayesian duration-response model. The primary analysis estimated the posterior probability that each duration was optimal, wherein optimal indicates the shortest duration consistent with the best outcome observed at any duration. Results:A total of 1158 patients were randomized (883 with nonshockable rhythms and 275 with shockable rhythms). Participants had a median age of 61 (IQR, 50-70) years and 39.6% were female. The trial met a prespecified stopping rule at the interim analysis. For the nonshockable rhythm cohort, the posterior probability that 6 hours was the shortest duration achieving the maximal mean weighted modified Rankin Scale score was 0.51. Results were similar in the shockable rhythm cohort. No differences were observed in secondary outcomes or mortality across cooling durations. Conclusions and Relevance:Among comatose survivors of out-of-hospital cardiac arrest treated with therapeutic hypothermia at 33 °C, increasing cooling duration did not improve neurological outcomes. Trial Registration:ClinicalTrials.gov Identifier: NCT04217551.
Introduction: Emergency department (ED) patients exhibit higher rates of depression than those in primary care and the general population, but it is unclear whether these symptoms reflect chronic conditions or transient responses to acute stress. Our objective in this study was to evaluate the longitudinal trajectory of depression and anxiety identified in the ED to inform evidence-based screening and intervention strategies. Methods: Adult, English-speaking ED patients with adequate literacy who presented to two urban academic EDs with somatic (non-psychiatric) chief complaints completed six mental health screening assessments at enrollment. Of 262 approached patients, 188 were enrolled, representing approximately 0.5% of all adult ED visits (188/37,898) during the study period. Follow-up assessments were completed through a secure phone app at one, two, and four weeks after ED discharge. The primary outcome was the longitudinal stability of depression and anxiety symptoms. The secondary outcome was differences in follow-up completion rates by baseline mental health status. Results: Among 188 patients with baseline assessments, 44 (23%) screened positive for major depressive disorder, 17 (9%) for moderate/severe depression, and 34 (18%) for moderate/severe anxiety at baseline. Overall, 50 patients (27%) screened positive for at least one of these conditions. Follow-up responses at weeks 1 (n = 42, 22%), 2 (n = 41, 22%), and 4 (n = 27, 14%) showed no significant changes in levels of depression as measured by the Computerized Adaptive Test-Depression Inventory or severity of anxiety as per the Computerized Adaptive Test for Anxiety severity. High intraclass correlation coefficients (0.76-0.84) for all measures indicated inter-individual differences accounted for most variance. Stability of the Computerized Adaptive Diagnostic Test for Major Depressive Disorder ranged from moderate to substantial (Cohen kappa: 0.74 at week 1 to 0.46 at week 4). Patients who were positive for major depressive disorder had significantly higher follow-up completion rates at weeks 2 and 4 (P = .04). Conclusion: High baseline rates of depression and anxiety highlight the substantial mental health burden in ED patients. Among those who completed follow-up assessments, severity scores remained stable, suggesting these symptoms reflect ongoing conditions rather than transient stress. Future work should improve follow-up responses and assess whether ED-based identification and treatment improve outcomes.
Acute brain injury (ABI)-mediated disruption of the microbiome causes inflammation and secondary brain injury (SBI). However, microbial-specific mediators and mechanisms remain unclear. Thirty-five consecutive patients with ABI admitted to the neuroscience critical care unit at the University of Chicago were prospectively studied. Injury severity at hospital admission was assessed using the Injury Severity Score (ISS) and the Glasgow Coma Scale (GCS). Final neurologic function was assessed via the Glasgow Outcome Score extended (GOSe). Serum, plasma, and stool targeted metabolomics, as well as stool shotgun metagenomics, were performed on longitudinal samples collected during hospitalization. Multivariate analysis identified microbiome-modified metabolites that were positively and negatively associated with functional outcomes after ABI. Novel identification of conjugated bile acid (BA) species and vitamin B12 precursors indicative of outcome were detected in the first collected samples (within 48 hours). Network analysis revealed greater integration of negatively associated metabolites across tissues and identified tauro-a/b-muricholic acid (TMCA) as central to the cross-tissue metabolomes. Microbiome metabolites may be useful in assessing brain injury outcomes to inform treatment, particularly with the convenience of blood collection.
Importance Therapeutic hypothermia is widely used for neuroprotection following cardiac arrest, but clinical trials have not consistently demonstrated improved neurological outcomes, and the optimal duration of cooling remains uncertain. Objective To determine the duration of therapeutic hypothermia that maximizes neurological recovery in comatose survivors of out-of-hospital cardiac arrest. Design, Setting, and Participants Multicenter, randomized, adaptive-allocation clinical trial conducted at 71 hospitals in the US. Adults with out-of-hospital cardiac arrest who remained unconscious, achieved a target temperature less than 34 °C within 4 hours of cardiac arrest, and had a definitive temperature control device started were eligible. Patients were enrolled between June 2020 and June 2025. Interventions Therapeutic hypothermia at 33 °C with adaptive randomized allocation to cooling durations of 6, 12, 18, 24, 30, 36, 42, 48, 60, and 72 hours. The first 200 patients were randomized to 12-, 24-, and 48-hour durations in a 1:1:1 ratio. Subsequently, a response-adaptive randomization algorithm allocated preferentially to the groups most likely to be optimal and to best inform the duration-response curve separately within each rhythm type. Main Outcomes and Measures The primary outcome was neurological function at 90 days, measured using a weighted modified Rankin Scale score, analyzed using a bayesian duration-response model. The primary analysis estimated the posterior probability that each duration was optimal, wherein optimal indicates the shortest duration consistent with the best outcome observed at any duration. Results A total of 1158 patients were randomized (883 with nonshockable rhythms and 275 with shockable rhythms). Participants had a median age of 61 (IQR, 50-70) years and 39.6% were female. The trial met a prespecified stopping rule at the interim analysis. For the nonshockable rhythm cohort, the posterior probability that 6 hours was the shortest duration achieving the maximal mean weighted modified Rankin Scale score was 0.51. Results were similar in the shockable rhythm cohort. No differences were observed in secondary outcomes or mortality across cooling durations. Conclusions and Relevance Among comatose survivors of out-of-hospital cardiac arrest treated with therapeutic hypothermia at 33 °C, increasing cooling duration did not improve neurological outcomes. Trial Registration ClinicalTrials.gov Identifier: NCT04217551
INTRODUCTION:To develop fast, intuitive, and accurate suicide risk screening, this study aimed to optimize 0-to-10 point suicide risk rulers. METHODS:662 adult patients from two emergency departments (EDs) completed five risk rulers, two best-practice screeners, and the Columbia Suicide Severity Rating Scale (CSSRS). Using the CSSRS as the reference, we calculated optimized cutoffs, performance metrics, and AUROCs for differentiating between negligible vs. elevated risk and non-high vs. high risk. Performances of rulers and best-practice screeners were compared. RESULTS:The rulers demonstrated acceptable performance when identifying elevated risk (AUROCs: 0.71-0.81) and stronger performance when identifying high risk (AUROCs: 0.91-0.95). The sadness ruler best predicted elevated risk (AUROC: 0.81 [95% CI: 0.76-0.86]; optimized score: 5 [3-7]; sensitivity: 0.71 [0.50-0.88]; specificity: 0.74 [0.61-0.89]). The suicidal ideation frequency ruler best predicted high risk (AUROC: 0.95 [0.85-1.00], optimized score: 2 [2-5]; sensitivity: 0.89 [0.60-1.00]; specificity: 0.95 [0.93-0.98]). The rulers outperformed a three-item primary screener, but not a longer 10-item primary and secondary screener, which best predicted both risk thresholds. CONCLUSIONS:Suicide risk rulers offer a fast, intuitive primary screening method for initial risk detection with acceptable operating characteristics. Our findings can inform the screening approach that best fits the needs of a given ED.
Importance:Presenteeism-defined as continuing to work during an illness-poses a public health risk in the workplace and is especially hazardous within health care institutions where vulnerable patients may be exposed to nosocomial infections. Understanding the frequency and characteristics of health care personnel (HCP) who report presenteeism while ill with COVID-19 may help mitigate SARS-CoV-2 spread in hospitals and other health care institutions. Objectives:To determine the frequency of presenteeism among HCP with symptomatic COVID-19, and to evaluate the demographic, occupational, and clinical factors associated with it. Design, Setting, and Participants:This is an observational cohort study that uses data from the Preventing Emerging Infections Through Vaccine Effectiveness Testing (PREVENT) project: a test-negative, case-control vaccine effectiveness study that enrolled HCP who had COVID-19 symptoms at 24 academic medical centers from December 2020 through April 2024. Exposure:Exposures include demographic, occupational, and clinical characteristics of participants. Main Outcomes and Measures:Having confirmed symptomatic COVID-19 infection and reporting presenteeism; overall frequency of presenteeism through the study period and the association of the exposure characteristics with presenteeism, adjusting for confounders using 3 multivariable models. Presenteeism was defined as HCP who did not stop working during their illness, but the study did not differentiate whether they continued working remotely. Results:A total of 3721 HCP were included in the analysis (2842 [76.4%] aged 18-49 years; 2993 [80.4%] female; 278 [7.5%] Asian, 406 [10.9%] Black, and 2912 [78.3%] White). Overall, 293 (7.9%) reported presenteeism during the study period, and the frequency of presenteeism increased each year of the study period (from 1 of 73 [1.4%] in 2020 to 16 of 105 [15.2%] in 2024). Presenteeism was associated with HCP who have minimal patient contact (adjusted odds ratio [aOR], 3.73; 95% CI, 2.39-4.37), a graduate or professional degree (aOR, 1.90; 95% CI, 1.45-2.50), and income over $100 000 (aOR, 1.74; 95% CI, 1.12-2.69). Conclusion and Relevance:In this observational cohort study of 3721 HCP, there was an increasing frequency of presenteeism from 2020 through 2024, and job role and socioeconomic factors were associated. More studies are needed to understand the rationale behind the decision to continue working and the exact causes of presenteeism's rising incidence among HCP with COVID-19.
This report evaluated responsiveness validity (sensitivity to change) for five ventricular assist device (VAD)-specific patient-reported outcomes (PROs). Patients at 12 U.S. sites completed PRO measures at months 3 and 6 post-VAD including: Being Bothered by VAD, Self-care and Limitations, Self-efficacy Regarding VAD Self-care, Treatment Satisfaction, VAD Team Communication, Stigma, Kansas City Cardiomyopathy Questionnaire (KCCQ-12), EQ-5D-3L, and Intermacs Post-Implant Quality of Life Form. Statistical methods included linear mixed effect models, analysis of variance methods and Pearson correlation coefficients (r). To evaluate sensitivity to change, VAD change scores were mapped to change in indicator variables (better, no change, worse). The VAD-specific PRO measures demonstrated preliminary evidence of responsiveness to change from month 3 to month 6. Use of these measures may assist VAD clinicians to inform patients about VADs as a treatment option and identify areas of concern that may guide interventions to support adjustment to having a VAD and enhance life quality. Clinical Trial Registration:ClinicalTrials.gov ID: NCT03044535.
BACKGROUND Acute brain injury (ABI)-mediated disruption of the microbiome may potentiate inflammation and secondary brain injury (SBI). However, microbial-specific mediators and mechanisms remain unclear. METHODS Thirty-five consecutive patients with ABI admitted to the neuroscience critical care unit at the University of Chicago were prospectively studied. Injury severity at hospital admission was assessed using the Injury Severity Score (ISS) and the Glasgow Coma Scale (GCS). Final neurologic function was assessed via the Glasgow Outcome Score extended (GOSe). Serum, plasma, and stool targeted metabolomics, as well as stool shotgun metagenomics, were performed on longitudinal samples collected during hospitalization. RESULTS Multivariate analysis identified microbiome-modified metabolites that were positively and negatively associated with functional outcomes after ABI. Novel identification of conjugated bile acid (BA) species and vitamin B12 precursors indicative of outcome were detected in the first collected samples (within 48 hours). Network analysis revealed greater integration of negatively associated metabolites across tissues and identified tauro-α/μ-muricholic acid (TMCA) as central to the cross-tissue metabolomes. CONCLUSIONS Microbiome metabolites may be useful in assessing brain injury outcomes to inform treatment. Bile acid species transformed by the gut microbiome are predictive of ABI outcome. ### Competing Interest Statement The authors have declared no competing interest. * TBI : traumatic brain injury ABI : acute brain injury SBI : secondary brain injury GCS : Glasgow Coma Scale ISS : Injury Severity Score GOSe : Glasgow Outcome Scale extended
Manual pulse checks for assessing return of spontaneous circulation (ROSC) during planned pauses of cardiopulmonary resuscitation (CPR) are central to all internationally endorsed cardiac arrest algorithms for advanced cardiac life support.1–3 Despite this, the rapid and accurate detection of central pulses in patients with spontaneous circulation by health care providers, even under laboratory conditions, is notoriously challenging.4–6 Manual pulse sensitivity can be further degraded under conditions of hypotension or large patient body habitus leading to a paradoxical scenario, termed pseudo-pulseless activity (pseudo-PEA), where manual pulses are not detected despite the presence of spontaneous coordinated cardiac activity on point-of-care ultrasound (POCUS).
BACKGROUND:Few study authors examined factors influencing health-related quality of life (HRQOL) early after left ventricular assist device (LVAD) implantation. OBJECTIVE:The purpose of this study was to determine whether 5 novel self-report measures and other variables were significantly associated with overall HRQOL at 3 months after LVAD surgery. METHODS:Patients were recruited between October 26, 2016, and February 29, 2020, from 12 US sites. Data were collected before LVAD implantation and at 3 months post LVAD implantation. Overall HRQOL measures included the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) overall summary score (OSS) and EuroQol 5-dimension- 3L visual analog scale. Potential factors associated with overall HRQOL included 5 novel self-report measures (Satisfaction with Treatment, Being Bothered by VAD Self-care and Limitations, VAD Team Communication, Self-efficacy regarding VAD Self-care, and Stigma), and demographic and clinical characteristics. Statistics included regression analyses. RESULTS:Of enrollees, 242 completed self-report measures at baseline, and 142 completed measures 3 months postoperatively. Patients were 55 ± 13 years old, with 21% female, 24% non-White, 39% high school or lower educated, and 47% destination therapy. Using the KCCQ-12 OSS, higher Satisfaction with Treatment was associated with a higher KCCQ-12 OSS; Being Bothered by VAD Self-care and Limitations, high school or lower education, chest incision pain, cardiac dysrhythmias within 3 postoperative months, and peripheral edema were associated with a worse KCCQ-12 OSS ( R2 = 0.524). Factors associated with a worse 3-month EuroQol 5-dimension-3L visual analog scale were female sex, adverse events within 3 months post implantation (cardiac dysrhythmias, bleeding, and venous thrombosis), and chest incision pain ( R2 = 0.229). No factors were associated with a higher EuroQol 5-dimension-3L visual analog scale score at 3 months. CONCLUSIONS:Two novel measures, demographics, postimplantation adverse events, and symptoms were associated with post-LVAD KCCQ-12 OSS early after surgery.
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. J Heart Lung Transplant 2024;43:1308-1317 (c) Published by Elsevier Inc. on behalf of International Society for Heart and Lung Transplantation.
Given the recent COVID-19 pandemic, there has been a push in the medical community for reliable, remote medical care. The ubiquity of smartphone devices has brought about much interest in the estimation of patient vital signs via an audio or video signal. Objective: In this paper, our objective is to estimate and compare respiratory rates from video, from audio, and jointly from video and audio for emergency department patients. Methods and procedures: For video, we use signal processing techniques, whereas for audio, we compare respiration rate estimates obtained using signal processing methods and learning-based methods due to the public availability of a large annotated audio corpus of breathing sounds. Results: On our collected audio-video corpus, we achieve the best Mean Absolute Error (MAE) of 2.53 when using video features. For the publicly available respiratory rate corpus, we achieve MAE of 1.63 when using signal processing methods. Conclusion: Based on the experimental results from our clinical data, we draw the conclusion that the video modality yields more accurate estimates when compared to the audio modality. Clinical impact: Accurate, contactless estimation of vital signs using video or audio is significant, because it can be performed remotely. Additionally, it is contactless and does not require extra measurement equipment.
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 de-veloped 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.J Heart Lung Transplant 2024;43:36-50 (c) 2023 International Society for Heart and Lung Transplantation. All rights reserved.
Background: Bivalent mRNA vaccines were recommended since September 2022. However, coverage with a recent vaccine dose has been limited, and there are few robust estimates of bivalent VE against symptomatic SARS-CoV-2 infection (COVID-19). We estimated VE of a bivalent mRNA vaccine dose against COVID-19 among eligible U.S. healthcare personnel who had previously received monovalent mRNA vaccine doses. Methods: We conducted a case-control study in 22 U.S. states, and enrolled healthcare personnel with COVID-19 (case-participants) or without COVID-19 (control-participants) during September 2022-May 2023. Participants were considered eligible for a bivalent mRNA dose if they had received 2-4 monovalent (ancestral-strain) mRNA vaccine doses, and were >= 67 days after the most recent vaccine dose. We estimated VE of a bivalent mRNA dose using conditional logistic regression, accounting for matching by region and four-week calendar period. We adjusted estimates for age group, sex, race and ethnicity, educational level, underlying health conditions,
The COVID-19 pandemic has underscored the need for low-cost, scalable approaches to measuring contactless vital signs, either during initial triage at a healthcare facility or virtual telemedicine visits. Remote photoplethysmography (rPPG) can accurately estimate heart rate (HR) when applied to close-up videos of healthy volunteers in well-lit laboratory settings. However, results from such highly optimized laboratory studies may not be readily translated to healthcare settings. One significant barrier to the practical application of rPPG in health care is the accurate localization of the region of interest (ROI). Clinical or telemedicine visits may involve sub-optimal lighting, movement artifacts, variable camera angle, and subject distance. This paper presents an rPPG ROI selection method based on 3D facial landmarks and patient head yaw angle. We then demonstrate the robustness of this ROI selection method when coupled to the Plane-Orthogonal-to-Skin (POS) rPPG method when applied to videos of patients presenting to an Emergency Department for respiratory complaints. Our results demonstrate the effectiveness of our proposed approach in improving the accuracy and robustness of rPPG in a challenging clinical environment.
Background Protection against symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (coronavirus disease 2019 [COVID-19]) can limit transmission and the risk of post-COVID conditions, and is particularly important among healthcare personnel. However, lower vaccine effectiveness (VE) has been reported since predominance of the Omicron SARS-CoV-2 variant. Methods We evaluated the VE of a monovalent messenger RNA (mRNA) booster dose against COVID-19 from October 2021 to June 2022 among US healthcare personnel. After matching case-participants with COVID-19 to control-participants by 2-week period and site, we used conditional logistic regression to estimate the VE of a booster dose compared with completing only 2 mRNA doses >150 days previously, adjusted for multiple covariates. Results Among 3279 case-participants and 3998 control-participants who had completed 2 mRNA doses, we estimated that the VE of a booster dose against COVID-19 declined from 86% (95% confidence interval, 81%-90%) during Delta predominance to 65% (58%-70%) during Omicron predominance. During Omicron predominance, VE declined from 73% (95% confidence interval, 67%-79%) 14-60 days after the booster dose, to 32% (4%-52%) ≥120 days after a booster dose. We found that VE was similar by age group, presence of underlying health conditions, and pregnancy status on the test date, as well as among immunocompromised participants. Conclusions A booster dose conferred substantial protection against COVID-19 among healthcare personnel. However, VE was lower during Omicron predominance, and waning effectiveness was observed 4 months after booster dose receipt during this period. Our findings support recommendations to stay up to date on recommended doses of COVID-19 vaccines for all those eligible.
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. (J Cardiac Fail 2023;29:1398-1411)
Purpose We developed 4 new measures: 1) Satisfaction with Treatment, 2) Being Bothered by Ventricular Assist Device (VAD) Self-care and Limitations, 3) VAD Team Communication, and 4) Self-efficacy Regarding VAD Self-care to assess adjustment of patients to living with a VAD. We aimed to evaluate the association of these new measures with health-related quality of life (HRQOL) 3 months after implant. Methods Patients with a left (L)VAD were recruited from 12 U.S. sites (10/26/16-9/9/19). HRQOL was measured pre- and 3 months post-implant using the EQ-5D Visual Analog Scale (VAS) and KCCQ-12 overall summary score (OSS). Covariates included the 4 new measures, pre-implant HRQOL, demographics, adverse events (within 3 months post-implant), implant strategy, and resources. Analyses included backward selection regressions using full information maximum likelihood estimation to account for missing values of covariates, p<0.05. Results Our sample, n=111 LVAD patients, were mean(SD) age=55(13) years, 21% female, 78% non-Hispanic White, and 47% destination therapy. Factors associated with worse 3-month VAS after adjustment for baseline VAS were female sex, adverse events within 3 months post-implant (cardiac arrhythmias, bleeding, and venous thrombosis), and chest pain (R2=0.229). None of the 4 new measures were independently associated with 3-month VAS. Satisfaction with Treatment was associated with better KCCQ-12 OSS; Being Bothered by VAD Self-care and Limitations, cardiac arrythmias, ≤ high school education, chest pain, and peripheral edema were associated with worse OSS (R2=0.501) (Table). Conclusion In addition to demographics, post-implant adverse events, and symptoms, 2 of our new measures (Treatment Satisfaction and Being Bothered by VAD Self-care and Limitations) were associated with post-LVAD KCCQ-12 OSS, but not EQ-5D VAS. Our study supports the importance of these new VAD self-report measures for understanding HRQOL.