Publications by authors named "J Randall Curtis"

3,215 Publications

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Improving communication about goals of care for hospitalized patients with serious illness: Study protocol for two complementary randomized trials.

Contemp Clin Trials 2022 Aug 10:106879. Epub 2022 Aug 10.

Cambia Palliative Care Center of Excellence at UW Medicine, University of Washington, Seattle, WA, United States of America; Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA, United States of America.

Background: Although goals-of-care discussions are important for high-quality palliative care, this communication is often lacking for hospitalized older patients with serious illness. Electronic health records (EHR) provide an opportunity to identify patients who might benefit from these discussions and promote their occurrence, yet prior interventions using the EHR for this purpose are limited. We designed two complementary yet independent randomized trials to examine effectiveness of a communication-priming intervention (Jumpstart) for hospitalized older adults with serious illness.

Methods: We report the protocol for these 2 randomized trials. Trial 1 has two arms, usual care and a clinician-facing Jumpstart, and is a pragmatic trial assessing outcomes with the EHR only (n = 2000). Trial 2 has three arms: usual care, clinician-facing Jumpstart, and clinician- and patient-facing (bi-directional) Jumpstart (n = 600). We hypothesize the clinician-facing Jumpstart will improve outcomes over usual care and the bi-directional Jumpstart will improve outcomes over the clinician-facing Jumpstart and usual care. We use a hybrid effectiveness-implementation design to examine implementation barriers and facilitators.

Outcomes: For both trials, the primary outcome is EHR documentation of a goals-of-care discussion within 30 days of randomization; additional outcomes include intensity of end-of-life care. Trial 2 also examines patient- or family-reported outcomes assessed by surveys targeting 3-5 days and 4-8 weeks after randomization including quality of goals-of-care communication, receipt of goal-concordant care, and psychological symptoms.

Conclusions: This novel study incorporates two complementary randomized trials and a hybrid effectiveness-implementation approach to improve the quality and value of care for hospitalized older adults with serious illness.

Clinical Trials Registration: STUDY00007031-A and STUDY00007031-B.
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http://dx.doi.org/10.1016/j.cct.2022.106879DOI Listing
August 2022

Abnormal Left Atrial Body Stiffness is Predicted by Appendage Size: Impact of Appendage Occlusion on Left Atrial Mechanics Assessed by Pressure-Volume Analysis.

Am J Physiol Heart Circ Physiol 2022 Aug 12. Epub 2022 Aug 12.

Division of Cardiovascular Medicine, Department of Internal Medicine, Keck School of Medicine of University of Southern California, Los Angeles, CA, United States.

Atrial cardiomyopathy has been recognized as having important consequences for cardiac performance and clinical outcomes. The pathophysiological role of the left atrial (LA) appendage and the effect of percutaneous left atrial appendage occlusion (LAAO) upon LA mechanics is incompletely understood. We evaluated if changes in LA stiffness due to endocardial LAAO can be detected by LA pressure-volume (PV) analysis and whether stiffness parameters are associated with baseline characteristics. Patients undergoing percutaneous endocardial LAAO (N = 25) were studied using a novel PV analysis using near-simultaneous 3D LA volume measurements by transesophageal echocardiography (TEE) and direct invasive LA pressure measurements. LA stiffness (dP/dV, change in pressure with change in volume) was calculated before and after LAAO. Overall LA stiffness significantly increased after LAAO compared to baseline (median, 0.41 to 0.64 mm Hg/mL; p <<0.001). LA body stiffness after LAAO correlated with baseline LA appendage size by indexed maximum depth (Spearman's rank correlation coefficient Rs = 0.61; p <0.01). LA stiffness change showed an even stronger correlation with baseline LA appendage size by indexed maximum depth (Rs = 0.70; p <0.001). We found that overall LA stiffness increases after endocardial LAAO. Baseline LA appendage size correlates with the magnitude of increase as well as LA body stiffness. These findings document alteration of LA mechanics after endocardial LAAO and suggest that the LA appendage modulates overall LA compliance.
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http://dx.doi.org/10.1152/ajpheart.00083.2022DOI Listing
August 2022

Indications for Left Atrial Appendage Occlusion in the United States and Associated In-Hospital Outcomes: Results From the NCDR LAAO Registry.

Circ Cardiovasc Qual Outcomes 2022 Aug 12:101161CIRCOUTCOMES121008418. Epub 2022 Aug 12.

Center for Outcomes Research and Evaluation Yale New Haven Health Services Corporation, New Haven, CT (Y.W., D.J.F., C.D., J.P.C., J.V.F.).

Background: The Food and Drug Administration approved left atrial appendage occlusion with the Watchman device for patients who are at increased stroke risk and are suitable for oral anticoagulation but who have an appropriate reason to seek a nondrug alternative. These broad criteria raise the question of their interpretation in clinical practice. There is a lack of studies comprehensively evaluating the indications for Watchman implantation among a large series of patients from contemporary, real-world practice in the United States.

Methods: We used the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry to identify Watchman procedures performed between 2016 and 2018. We assessed procedural indications for Watchman implantation in the United States and evaluated the association between procedural indications and in-hospital adverse events.

Results: A total of 38 314 procedures were included. The mean patient age was 76.1±8.1 years, and 58.9% were men. The mean CHADS-VASc score was 4.8±1.5, whereas the mean hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol (HAS-BLED) score was 3.0±1.1. Prior stroke or transient ischemic attack was reported in 40.2% and prior bleeding in 70.1%, with gastrointestinal bleeding being most common (41.9%). The most common site-reported procedural indications for Watchman implantation were increased thromboembolic risk (64.8%) and history of major bleed (64.3%), followed by high fall risk (35.5%). Most (71.9%) had ≥2 procedural indications. Patients with high fall risk had increased risk of in-hospital adverse events (adjusted OR, 1.12; =0.025), but no other differences were found in the risk of in-hospital adverse events by procedural indication.

Conclusions: Among patients in the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry, the most common procedural indications for Watchman implantation were increased thromboembolic risk, history of major bleed, and high fall risk. A majority of patients had multiple procedural indications. High fall risk conferred a modestly increased risk of in-hospital adverse events.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.121.008418DOI Listing
August 2022

The Effect of Guselkumab on Work Productivity in Biologic-Naïve Patients with Active Psoriatic Arthritis Through Week 52 of the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Trial.

Adv Ther 2022 Aug 10. Epub 2022 Aug 10.

Department of Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, USA.

Introduction: The phase 3 DISCOVER-2 trial evaluated the effect of guselkumab on impaired work productivity and nonwork activity in biologic-naïve patients with psoriatic arthritis (PsA).

Methods: Adults with active PsA were randomized (1:1:1) to guselkumab 100 mg every 4 weeks (Q4W), guselkumab 100 mg at weeks 0 and 4 and then every 8 weeks (Q8W), or placebo (with crossover to guselkumab Q4W at week 24). Least squares mean change from baseline in Work Productivity and Activity Impairment Questionnaire for PsA (WPAI-PsA) domains and employment were assessed by treatment group. Multivariate analysis of data from weeks 0 through 24 assessed independent associations between PsA clinical features and WPAI-PsA domains.

Results: In total, 738 patients were evaluated (guselkumab Q4W n = 245; guselkumab Q8W n = 248; placebo n = 245). At week 24, improvements (reduced impairment) in presenteeism (Q4W -20.1%, Q8W -19.6%, placebo -10.5%), work productivity (Q4W -20.1%, Q8W -19.2%, placebo -10.6%), and nonwork activity (Q4W -20.5%, Q8W -21.2%, placebo -9.9%) were greater in guselkumab-treated versus placebo-treated patients. At week 52, following placebo crossover at week 24, improvements were similar among groups. Baseline absenteeism was minimal and did not change in any group. By week 52, 23.1-25.9% of guselkumab-treated patients who were unemployed at baseline were employed. All WPAI-PsA domains were positively associated with C-reactive protein level, fatigue, and pain. All domains except absenteeism were positively associated with enthesitis and Psoriasis Area and Severity Index score. Age was negatively associated with presenteeism and work productivity loss, female sex and tender joint count were positively associated with nonwork activity impairment, and dactylitis was positively associated with presenteeism.

Conclusion: Both guselkumab regimens reduced work productivity loss and nonwork activity impairment in patients with active PsA. Association of work productivity loss and nonwork activity impairment with PsA joint and skin features suggests that improvement in both features is beneficial for optimizing improved work productivity loss and nonwork activity impairment.

Trial Registration: ClinicalTrials.gov identifier, NCT03158285.
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http://dx.doi.org/10.1007/s12325-022-02270-7DOI Listing
August 2022

The Effect of Guselkumab on General Health State in Biologic-Naïve Patients with Active Psoriatic Arthritis Through Week 52 of the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Trial.

Adv Ther 2022 Aug 10. Epub 2022 Aug 10.

Department of Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, USA.

Introduction: In DISCOVER-2, guselkumab, an interleukin-23 p19 subunit inhibitor, was efficacious in biologic-naïve psoriatic arthritis (PsA) patients. We report the effect of guselkumab on health-related quality of life (HRQoL) using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index and Visual Analog Scale (EQ-VAS) through Week 52.

Methods: Adults with active PsA were randomized to guselkumab 100 mg every 4 weeks (Q4W) or Weeks 0, 4, then every 8 weeks (Q8W), or placebo (crossover to guselkumab Q4W at Week 24). Least squares (LS) mean changes in EQ-5D-5L Index (0-1, US-based value set) and EQ-VAS (0-100) from baseline through Week 52 were assessed. Proportions of patients achieving minimally important differences (MIDs) were assessed through Week 52. Associations between patient clinical features and EQ-5D-5L Index and EQ-VAS scores were examined cross-sectionally with pooled data through Week 24.

Results: The analysis included 738 patients (Q4W n = 245; Q8W n = 248; placebo n = 245). At Week 24, LS mean changes from baseline in the Q4W, Q8W, and placebo groups were 0.12, 0.12, and 0.05, respectively, for EQ-5D-5L Index, and 18.2, 18.4, and 6.8, respectively, for EQ-VAS. At Week 52, improvement was maintained in the guselkumab groups and increased in the placebo crossover group. EQ-5D-5L Index MID was achieved by 56.0% in each guselkumab group at Week 24 and 66.2% in Q4W, 68.5% in Q8W, and 66.1% in placebo crossover group at Week 52. Higher C-reactive protein level, Psoriasis Area and Severity Index score, fatigue, and pain were correlated with worse EQ-5D-5L Index and EQ-VAS, based on pooled data through Week 24. Higher tender joint count was correlated with worse EQ-5D-5L, while higher swollen joint count was correlated with worse EQ-VAS.

Conclusions: Guselkumab improved HRQoL through 52 weeks in patients with active PsA. Impairment in HRQoL was correlated with increased inflammation, fatigue, pain, and measures of skin and joint symptom severity.

Clinicaltrials: GOV: NCT03158285.
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http://dx.doi.org/10.1007/s12325-022-02269-0DOI Listing
August 2022
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