Faculty Bibliography

BACKGROUND/UNASSIGNED:In team science, invitation to writing groups can be subjective and secretive. Confronted with this challenge in the ISCHEMIA trial, with 320 participating sites, 4 coordinating centers, 6 core laboratories, and numerous committees, we adapted an existing model to develop a transparent, objective, and equitable method for determining authorship eligibility. METHODS/UNASSIGNED:We developed a scoring system based on site performance of tasks critical to trial success that meet the ICJME criteria for authorship. Sites were ranked according to points earned, and points required for potential authorship were communicated to all sites. Site investigators were surveyed for their manuscript topic preferences for writing groups. Beyond the point-based system, authorship positions were also reserved for trial contributors who were not site investigators. RESULTS/UNASSIGNED:To date, 50 original, peer-reviewed ISCHEMIA trial manuscripts have been published. In total, 208 authors from 33 countries participated in at least one publication. Of the 87 sites that randomized at least 15 participants over a mean of 5 years, 72% had authorship positions across published manuscripts. Surveys were sent to 334 site investigators and 27% responded. Among respondents, 61% indicated that ISCHEMIA was the first trial they had worked on with performance-based criteria for authorship invitation. Respondents agreed the system was transparent (81%), objective (83%), and equitable for early career researchers (70%) and underrepresented minorities in research (57%). CONCLUSIONS/UNASSIGNED:ISCHEMIA employed a point-based authorship eligibility system that most authors found objective, merit-based, transparent, and equitable. Implementation of such a system should be considered for team science publications.

IMPORTANCE/UNASSIGNED:Lung cancer screening (LCS) with low-dose computed tomography (CT) remains underused in the US, partly because of incomplete smoking history documentation in electronic health records (EHRs) and limited time for shared decision-making in primary care. OBJECTIVE/UNASSIGNED:To determine whether a patient-facing, EHR-integrated tool combined with clinician-facing clinical decision support improves the identification of LCS-eligible patients and the ordering of low-dose CT compared with clinician-facing tools alone. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This pragmatic, unstratified, randomized clinical trial with parallel groups was conducted from March 29, 2024, to March 28, 2025, at primary care clinics at University of Utah Health and New York University Langone Health. Adults aged 50 to 79 years with a documented smoking history, an active patient portal account, and a primary care visit in the preceding year were included. Study 1 enrolled patients with uncertain LCS eligibility (10 to 19 pack-years, unknown pack-years, or missing quit date); study 2 enrolled patients with documented eligibility (20 or more pack-years and currently smoking or quit smoking within 15 years). INTERVENTIONS/UNASSIGNED:The control included the clinician-facing Decision Precision+ tool (preventive care reminders and a shared decision-making tool). The intervention included the Decision Precision+ tool as well as the MyLungHealth tool, which collected detailed smoking history (study 1) and delivered personalized education and risk/benefit information (studies 1 and 2) via the patient portal in English and Spanish. MAIN OUTCOMES AND MEASURES/UNASSIGNED:The primary outcomes were the proportion of patients newly identified as eligible for LCS (study 1) and low-dose CT ordering rates (study 2) over 12 months. Analyses used intention-to-treat mixed-effects logistic regression. RESULTS/UNASSIGNED:There were 31 303 randomized participants, including 26 729 in study 1 (13 144 [49.2%] female; 13 580 [50.8%] male; median [IQR] age, 62 [55-69] years) and 4574 in study 2 (2230 [48.8%] female; 2344 [51.2%] male; median [IQR] age, 63 [56-69] years). In study 1, the MyLungHealth tool increased new LCS eligibility identification (635 of 13 412 [4.7%] vs 308 of 13 317 [2.3%]; adjusted odds ratio, 2.19; 95% CI, 1.99-2.42; P < .001). In study 2, low-dose CT ordering was higher in the intervention arm (474 of 2312 [20.5%] vs 434 of 2262 [19.2%]; adjusted odds ratio, 1.16; 95% CI, 1.04-1.30; P = .008). CONCLUSIONS AND RELEVANCE/UNASSIGNED:In this randomized clinical trial, integrating a patient-centered tool into primary care EHR workflows increased the identification of patients eligible for LCS and the ordering of low-dose CTs. The relative increases in these primary outcomes were substantial, but absolute increases were more modest. Research on more intensive interventions is warranted to evaluate their ability to further improve LCS screening. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT06338592.

BACKGROUND:Keloids are common in genetically predisposed individuals and in darker skin types, and treatment is especially challenging; the most commonly used therapeutic options return inconsistent results and often result in recurrence. Despite their prevalence and therapeutic challenges, keloids remain understudied and are often conflated with hypertrophic scars in the literature, though these conditions likely have distinct biomechanical etiologies. There remains a need for better optimization and comparison of existing treatment modalities to more effectively manage keloidal scarring. METHODS:Thirteen patients with two similar keloids or one large keloid completed four treatments of a fractionally ablative erbium YAG laser, followed by application of either triamcinolone 10 mg/mL solution to one keloid or one half of the keloid or 5-fluorouracil solution 50 mg/mL solution to the second keloid or the other half of the keloid. Photos and measurements of the keloids were taken at each visit. The Patient and Observer Scar Assessment Scale (POSAS) score was recorded by the participants and the blinded physician observer at each visit. Blinded dermatologist observers completed the Hamilton score based on the scar photographs. RESULTS:; there was not a statistically significant difference between the two (p = 0.56). Ten out of 13 patients were Fitzpatrick skin types IV-VI. There were no serious adverse events reported. CONCLUSION/CONCLUSIONS:In this pilot study of keloid patients, POSAS scores significantly improved after both laser-assisted TAC delivery and laser-assisted 5-FU delivery, with no statistically significant difference between the two treatment arms. However, there was a noted discrepancy in patient reports of post-procedural hyperpigmentation, with more patients experiencing this adverse effect within the 5-FU arm than in the TAC arm. While fractionally ablative laser-assisted drug delivery with either 5-FU or TAC is a safe and effective method to treat keloids, special attention should be paid to hyperpigmentation as a possible adverse effect in patients with darker skin tones, who are disproportionately affected by both keloids and hyperpigmentation.

OBJECTIVES/OBJECTIVE:To evaluate whether ultrasound-guided preoperative localization of soft tissue masses in the musculoskeletal system using a wireless radar reflector reduces operative times and reoperation rates compared to a control group referred by the same oncology team. METHODS:Retrospective review of SAVI SCOUT radar localizations performed preoperatively for soft tissue masses between 2021 and 2025. All imaging, clinical details, and operative times were evaluated. Comparison was made between the localized group and a control group matched for demographics (age and sex), comorbidities (American Society of Anesthesiologists score), location (trunk versus appendicular; subcutaneous versus deep/subfascial), histopathology (benign versus malignant), and case complexity (primary closure versus flap reconstruction). Cases were performed by the same oncological surgical team referred directly or via the multidisciplinary tumor board during the same time course. RESULTS:Twenty-four radar localized cases were compared with 24 control cases. Median case time in the SAVI SCOUT group was 52.0 minutes (interquartile range 38.0) and there was no significant difference in case times between the localized and control groups (p > .05). There were no reoperations in the localized group whereas 5 patients in the non-localized control group underwent reoperation for positive margins, though this difference fell short of statistical significance (p = .056). The most common lesions in the localized group were metastatic melanoma (12.5%) and intramuscular myxoma (8.3%), liposarcoma (8.3%), and metastatic leiomyosarcoma (8.3%). CONCLUSIONS:Preoperative localization demonstrated no substantial improvement in operative time compared to the non-localized group. However, re-resection rates were higher in the non-localized group.

BACKGROUND:Access to liver transplantation (LT) for pediatric registrants is complex and impacted by many factors. Assessing the state of pediatric LT requires understanding the balance between policy, the availability of livers, and the quantity of pediatric patients requiring LT. METHODS:Using Scientific Registry of Transplant Recipients data with Cox regression (to compare rates) and competing risk regression (to compare cumulative incidence), we evaluated pediatric patient characteristics, number of registrants transplanted, and waitlist mortality from (January 1, 2017-February 4, 2020) to (May 1, 2020-June 4, 2023) using the implementation of acuity circles to divide the eras. RESULTS:In 4314 pediatric LT registrants, transplantation rate increased in the post-policy era, compared with the pre-policy era (adjusted hazard ratio [HR], 1.05 1.12 1.20 ; P  < 0.001). When accounting for competing risks, the increase was attenuated and not statistically significant (adjusted subdistribution HR, 0.99 1.06 1.14 ; P  = 0.08); recipients were no more likely to die on the waitlist (adjusted subdistribution HR, 0.78 1.01 1.30 ; P  = 0.99). Importantly, the prevalent pediatric waitlist dropped from 396 (2017) to 225 (2023), the rate of deceased donor LT from pediatric donors increased (weighted HR, 1.20 1.31 1.42 ; P  < 0.001), and access to living donor LT increased, compared with the pre-policy era (weighted HR, 1.11 1.33 1.59 ; P  = 0.002). The transplant rate for pediatric patients did not decrease during the study period despite the introduction of acuity circles. During the study period, the prevalent waitlist shrank, access to LT from pediatric donors increased, and access to living donor LT increased. CONCLUSIONS:Comprehensive assessment following the policy change is necessary to ensure that pediatric candidates maintain priority. Changes in pediatric transplantation are modest and likely related to changes in the pool, rather than to the policy of acuity circles.

The detection and identification of intracranial tumours is limited by the lack of accurate biomarkers and requires invasive biopsy procedures. We investigated a machine perception liquid biopsy approach to detect and identify intracranial tumours from peripheral blood and to discover biomarkers responsible for the predictions. Quantum well defect-modified single-walled carbon nanotubes stabilized with single-stranded DNA, interrogating 739 plasma samples from brain tumour patients, were used to train and validate machine-learning models to detect intracranial tumours with 98% accuracy and identify tumour type. The protein corona of the top model-contributing nanosensor was interrogated using quantitative proteomics, resulting in the identification of tumour ecosystem-secreted factors, both previously reported and newly discovered, originating from intracranial tumour cells, the tumour microenvironment and the innate immune system of patients with glioblastoma and meningioma. Newly discovered factors elicited linear nanosensor responses and were elevated in one or both tumour types, matching the original protein corona enrichment. This investigation reveals that a perception-based detection of disease in blood can identify biomarkers responsible for the signal and also amplify cancer detection signals by detecting factors beyond tumour cells, thereby recruiting the entire tumour ecosystem for cancer diagnosis.

OBJECTIVE:To evaluate whether the risk of long COVID among individuals infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during pregnancy differs from that of individuals who were not pregnant at time of virus acquisition. METHODS:We conducted a multicenter observational cohort study at 79 NIH RECOVER (Researching COVID to Enhance Recovery) sites. Individuals assigned female at birth aged 18-45 years with an index (first) SARS-CoV-2 infection on or after December 1, 2021, were included. The exposure was pregnancy (any gestational age) at the time of index SARS-CoV-2 infection. The primary outcome was long COVID 6 months after index infection , defined as RECOVER-Adult Long COVID Research Index score 11 or higher based on a detailed symptom survey. To account for confounding and differential selection between participants who were pregnant and not pregnant at infection, propensity score-matching methods were used to balance the groups on variables potentially associated with both pregnancy status and long COVID. RESULTS:Overall 2,423 participants were included; 580 (23.9%) were pregnant at index SARS-CoV-2 infection. The median age at infection was 33 years (interquartile range 28-38 years), and 2,131 of participants (90.0%) with known vaccination status were vaccinated. After propensity score matching, the adjusted long COVID prevalence estimates 6 months after index infection were 10.2% (95% CI, 6.2-14.3%) among those pregnant at infection and 10.6% (95% CI, 8.8-12.4%) among those not pregnant at infection. Pregnancy was not associated with a difference in adjusted risk of long COVID (adjusted risk ratio 0.96, 95% CI, 0.63-1.48). CONCLUSION/CONCLUSIONS:Acquisition of SARS-CoV-2 during pregnancy was not associated with a differential risk of long COVID at 6 months compared with similar-aged individuals who acquired SARS-CoV-2 outside of pregnancy.

BACKGROUND/UNASSIGNED:It remains unknown how often, and to which extent, patients with diabetes and non-ST-segment-elevation myocardial infarction are revascularized. This study aimed to identify practice patterns and clinical outcomes in patients with diabetes and non-ST-segment-elevation myocardial infarction according to completeness of revascularization. METHODS/UNASSIGNED:All patients with diabetes and multivessel disease hospitalized for non-ST-segment-elevation myocardial infarction in Ontario, Canada, between April 2009 and March 2020 and undergoing coronary angiography were included. Patients with previous coronary artery bypass grafting (CABG) at any time, percutaneous coronary intervention (PCI) in the previous 90 days, or an ST-segment-elevation myocardial infarction in the previous 90 days were excluded, as were patients with hemodynamic instability at hospital admission. Patients were classified into 4 groups, from the most to the least complete revascularization strategy: CABG, complete revascularization with PCI, incomplete PCI, or no revascularization. The primary outcome was all-cause death at 5 years. Cox regression adjusted for multiple baseline characteristics was used to compare outcomes between groups. RESULTS/UNASSIGNED:We included 14 511 patients (mean age: 68.7±11.5 years; 69.6% male patients); 4525 (31.2%) were treated with CABG, 3008 (20.7%) with complete PCI, 3624 (25.0%) with incomplete PCI, and 3354 (23.1%) did not receive any revascularization procedure. Adjusted 5-year risks of all-cause death after CABG, complete PCI, incomplete PCI, and no revascularization were progressively increased: 25.9%, 29.8%, 32.2%, and 39.4% respectively. Compared with no revascularization, a 46% reduction in all-cause death was observed after CABG (hazard ratio, 0.54 [95% CI, 0.50-0.58]), 35% after complete PCI (hazard ratio, 0.65 [95% CI, 0.60-0.71]), and 27% after incomplete PCI (hazard ratio, 0.73 [95% CI, 0.68-0.79]), over a median follow-up of 5.8 years (interquartile range, 3.3-8.6). CONCLUSIONS/UNASSIGNED:Almost a quarter of the patients with diabetes and non-ST-segment-elevation myocardial infarction did not receive any revascularization procedure. There was an incremental mortality reduction associated with CABG or complete revascularization with PCI, compared with incomplete revascularization with PCI or no revascularization.