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Abstract INTRODUCTION DSC-MRI perfusion methods are commonly used to evaluate both primary and metastatic brain cancer with the creation of maps of relative cerebral blood volume (rCBV). Recently, guidelines were established to ensure a standard DSC-MRI acquisition protocol that reduces inter-site variability. The purpose of this study was to initiate the determination of rCBV benchmark values using the DSC-MRI consensus protocol in treatment-naïve brain metastases. METHODS Patients from three sites with treatment-naïve, contrast-enhancing brain metastases on MRI were considered for inclusion in this retrospective study. The MRIs included pre- and post-contrast T1w(T1+C) images obtained after administration of gadolinium-based contrast agent (GBCA) (0.1 mmol/kg), which serves as the recommended preload for the DSC-MRI data collection. A 2nd GBCA dose (0.1 mmol/kg) was administered 40-60sec after the collection of baseline GRE-EPI images using recommended settings (FA=60o, TE/TR=30ms/1100-1250ms) for 120s. Calibrated pre/post T1w difference maps (dT1) were used for delineation of enhancing lesion, and standardized (calibrated) rCBV (sRCBV) created. Mean sRCBV for metastases were compared to normal appearing white matter (NAWM) and treatment-naive glioblastoma (GBM) from a previous study. Pairwise comparisons were performed using the Mann-Whitney nonparametric test. RESULTS N=52 patients with primary histology of lung (n=27); breast (n=6); skin (n=7); gastrointestinal (GI: n=3) and genitourinary (GU: n=9) cancers were included in comparison to GBM (n=31). The mean sRCBV for all metastases (1.77+/-1.05) is significantly lower (p=0.0003) than for GBM (2.67+/-1.34) but with both statistically greater (p< 0.0001) than NAWM (0.706+/-0.163). Individually, lung (1.47+/- 0.61), breast (2.275+/-0.87), skin (2.10+/-1.22), GI (1.91+/- 0.64) and GU (2.01+/-0.63) mean sRCBV are statistically greater than for NAWM. CONCLUSION Using the consensus DSC-MRI acquisition protocol confirms use of sRCBV to identify biologically active, treatment-naive brain metastases setting benchmark values for future applications.

Telemedicine approaches provide many benefits to patients across both primary and specialty care. Patient acceptance is imperative to successful telemedicine implementation. As telemedicine utilization continues to surge, it is imperative that healthcare organizations have a method for evaluating the patient experience with these types of visits. Previous studies on experience with telemedicine have focused on smaller patient populations with narrow inclusion criteria and limited geographical reach. This research described how patients’ satisfaction with video telemedicine-based visits varied based on patient characteristics and how they compare with in-person visits. We obtained and analyzed results from standardized patient experience surveys to compare telemedicine and in-person clinic visits during the COVID-19 pandemic (between July 1, 2020, and June 30, 2021) across a diverse patient population. During the study timeframe, surveys were sent to 1,521,398 patients with a response rate of 20% (307,185). Our organization’s unique structure, size, and geographic spread allowed for a deeper and more comprehensive examination of telemedicine participants. Though a few trends emerged in the results, there were no significant differences in patient ratings of telemedicine visits and in-person clinic visits during the same period (p=0.672). This study demonstrated that patient satisfaction with telemedicine visits was non-inferior to in-person outpatient visits during the study timeframe. Experience Framework This article is associated with the Innovation & Technology lens of The Beryl Institute Experience Framework (https://www.theberylinstitute.org/ExperienceFramework). Access other PXJ articles related to this lens. Access other resources related to this lens

Study Design: Prospective randomized Food and Drug Administration investigational device exemption clinical trial. Objective: The purpose of the present study is to report the 1-year clinical and radiographic outcomes and safety profile of patients who underwent lumbar facet arthroplasty through implantation of the Total Posterior Spine System (TOPS) device. Summary of Background Data: Lumbar facet arthroplasty is one proposed method of dynamic stabilization to treat grade-1 spondylolisthesis with stenosis; however, there are currently no Food and Drug Administration-approved devices for facet arthroplasty. Methods: Standard demographic information was collected for each patient. Radiographic parameters and patient-reported outcome measures were assessed preoperatively and at regular postoperative intervals. Complication and reoperation data were also collected for each patient. Results: At the time of this study, 153 patients had undergone implantation of the TOPS device. The mean surgical time was 187.8 minutes and the mean estimated blood loss was 205.7cc. The mean length of hospital stay was 3.0 days. Mean Oswestry Disability Index, Visual Analog Score leg and back, and Zurich Claudication Questionnaire scores improved significantly at all postoperative time points (P>0.001). There were no clinically significant changes in radiographic parameters, and all operative segments remained mobile at 1-year follow-up. Postoperative complications occurred in 11 patients out of the 153 patients (7.2%) who underwent implantation of the TOPS device. Nine patients (5.9%) underwent a total of 13 reoperations, 1 (0.6%) of which was for device-related failure owing to bilateral L5 pedicle screw loosening. Conclusions: Lumbar facet arthroplasty with the TOPS device demonstrated a statistically significant improvement in all patient-reported outcome measures and the ability to maintain motion at the index level while limiting sagittal translation with a low complication rate.

68 Background: Accrual of racial and ethnic minority patients (pts) to clinical trials has been an ongoing challenge in research. Barriers exist at many levels of engagement including trial availability, screening biases, strict enrollment criteria, and structural racism. Lack of trial diversity has led to less generalizable medical evidence, suboptimal data for toxicity and efficacy of cancer treatments, poorer outcomes and continued mistrust by communities of color in research processes that exclude or marginalize them. Site factors and study design strategies associated with successful recruitment of diverse study populations are understudied. Methods: Alliance A191901 is an RCT testing combinations of text and telephone support to promote endocrine therapy adherence among breast cancer survivors. It oversamples Black participants and those < 50 years at thresholds of 30% each. Administrative enrollment data was used to track and describe monthly accrual trajectory by race among the initial 50% of participants (n = 590) and to examine associations between % Black participants accrued and accruing site characteristics, including site type, geographic region, % Black population in the site’s zip code and volume of pts by race accrued to recent (2018-2019) Alliance trials, using χ2 tests. We also examined patterns of Black participant accrual before and after closure of the A191901 study to non-Black participants. Results: At 50% accrual, 124 sites had enrolled at least 1 participant. Among 590 participants, 9.7% were Black and 22.5% were < 50 years. Neither site type nor volume was associated with % Black participants recruited. Sites in the South recruited higher proportions of Blacks (19.0% vs 5.6% for Midwest, the lowest region, p < 0.001). Neighborhood racial composition was positively associated with accrual of Black participants (17.2% at sites from highest Black composition vs. 2.3% in lowest, p < 0.001). Recruitment trajectories of Black participants consistently lagged those of non-Black participants in the first half of the study; however, Black participants recruited per month numerically increased after the study reached target accrual of non-Blacks and closed to non-Black participants. Conclusions: Sites in neighborhoods and geographic regions with larger Black populations recruited higher proportions of Black participants, but site type and volume were not associated with recruitment of Black participants. Closure of non-Black study strata based on predetermined accrual targets may positively impact recruitment trajectories of Black participants, but further study is needed. Site selection based on neighborhood composition and geography may be an appropriate tool for increasing trial diversity. Support: UG1CA189823. Clinical trial information: NCT04379570.

Objective As of early 2021, there have been over 3.5 million pediatric cases of SARS-CoV-2, including 292 pediatric deaths in the United States. Although most pediatric patients present with mild disease, they are still at risk for developing significant morbidity requiring hospitalization and intensive care unit (ICU) level of care. This study was performed to evaluate if the presence of concurrent respiratory viral infections in pediatric patients admitted to the hospital with SARS-CoV-2 was associated with an increased rate of ICU level of care. Design A multicenter, international, noninterventional, cross-sectional study using data provided through The Society of Critical Care Medicine Discovery Network Viral Infection and Respiratory Illness Universal Study database. Setting The medical ward and ICU of 67 participating hospitals. Patients Pediatric patients younger than 18 years hospitalized with SARS-CoV-2. Interventions None. Measurements and Main Results A total of 922 patients were included. Among these patients, 391 required ICU level care and 31 had concurrent non–SARS-CoV-2 viral coinfection. In a multivariate analysis, after accounting for age, positive blood culture, positive sputum culture, preexisting chronic medical conditions, the presence of a viral respiratory coinfection was associated with need for ICU care (odds ratio, 3.6; 95% confidence interval, 1.6–9.4; P < 0.01). Conclusions This study demonstrates an association between concurrent SARS-CoV-2 infection with viral respiratory coinfection and the need for ICU care. Further research is needed to identify other risk factors that can be used to derive and validate a risk-stratification tool for disease severity in pediatric patients with SARS-CoV-2.

Background: Prior “best practice guidelines” (BPG) have identified strategies to reduce the risk of acute deep surgical site infection (SSI), but there still exists large variability in practice. Further, there is still no consensus on which patients are “high risk” for SSI and how SSI should be diagnosed or treated in pediatric spine surgery. We sought to develop an updated, consensus-based BPG informed by available literature and expert opinion on defining high-SSI risk in pediatric spine surgery and on prevention, diagnosis, and treatment of SSI in this high-risk population. Materials and Methods: After a systematic review of the literature, an expert panel of 21 pediatric spine surgeons was selected from the Harms Study Group based on extensive experience in the field of pediatric spine surgery. Using the Delphi process and iterative survey rounds, the expert panel was surveyed for current practices, presented with the systematic review, given the opportunity to voice opinions through a live discussion session and asked to vote regarding preferences privately. Two survey rounds were conducted electronically, after which a live conference was held to present and discuss results. A final electronic survey was then conducted for final voting. Agreement ≥70% was considered consensus. Items near consensus were revised if feasible to achieve consensus in subsequent surveys. Results: Consensus was reached for 17 items for defining high-SSI risk, 17 items for preventing, 6 for diagnosing, and 9 for treating SSI in this high-risk population. After final voting, all 21 experts agreed to the publication and implementation of these items in their practice. Conclusions: We present a set of updated consensus-based BPGs for defining high-risk and preventing, diagnosing, and treating SSI in high-risk pediatric spine surgery. We believe that this BPG can limit variability in practice and decrease the incidence of SSI in pediatric spine surgery. Level of Evidence: Not applicable.

Abstract To develop a suite of quality indicators (QIs) for the management of patients with ventricular arrhythmias (VA) and the prevention of sudden cardiac death (SCD). The Working Group comprised experts in heart rhythm management including Task Force members of the 2022 European Society of Cardiology (ESC) Clinical Practice Guidelines for the management of patients with VA and the prevention of SCD, members of the European Heart Rhythm Association, international experts, and a patient representative. We followed the ESC methodology for QI development, which involves (i) the identification of the key domains of care for the management of patients with VA and the prevention of SCD by constructing a conceptual framework of care, (ii) the development of candidate QIs by conducting a systematic review of the literature, (iii) the selection of the final set of QIs using a modified-Delphi method, and (iv) the evaluation of the feasibility of the developed QIs. We identified eight domains of care for the management of patients with VA and the prevention of SCD: (i) structural framework, (ii) screening and diagnosis, (iii) risk stratification, (iv) patient education and lifestyle modification, (v) pharmacological treatment, (vi) device therapy, (vii) catheter ablation, and (viii) outcomes, which included 17 main and 4 secondary QIs across these domains. Following a standardized methodology, we developed 21 QIs for the management of patients with VA and the prevention of SCD. The implementation of these QIs will improve the care and outcomes of patients with VA and contribute to the prevention of SCD.

Background. There is no standard definition for “HLA incompatible” transplants. For the first time, we systematically assessed how HLA incompatibility was defined in contemporary peer-reviewed publications and its prognostic implication to transplant outcomes. Methods. We combined 2 independent searches of MEDLINE, EMBASE, and the Cochrane Library from 2015 to 2019. Content-expert reviewers screened for original research on outcomes of HLA-incompatible transplants (defined as allele or molecular mismatch and solid-phase or cell-based assays). We ascertained the completeness of reporting on a predefined set of variables assessing HLA incompatibility, therapies, and outcomes. Given significant heterogeneity, we conducted narrative synthesis and assessed risk of bias in studies examining the association between death-censored graft failure and HLA incompatibility. Results. Of 6656 screened articles, 163 evaluated transplant outcomes by HLA incompatibility. Most articles reported on cytotoxic/flow T-cell crossmatches (n = 98). Molecular genotypes were reported for selected loci at the allele-group level. Sixteen articles reported on epitope compatibility. Pretransplant donor-specific HLA antibodies were often considered (n = 143); yet there was heterogeneity in sample handling, assay procedure, and incomplete reporting on donor-specific HLA antibodies assignment. Induction (n = 129) and maintenance immunosuppression (n = 140) were frequently mentioned but less so rejection treatment (n = 72) and desensitization (n = 70). Studies assessing death-censored graft failure risk by HLA incompatibility were vulnerable to bias in the participant, predictor, and analysis domains. Conclusions. Optimization of transplant outcomes and personalized care depends on accurate HLA compatibility assessment. Reporting on a standard set of variables will help assess generalizability of research, allow knowledge synthesis, and facilitate international collaboration in clinical trials.