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Background: The COVID-19 pandemic has created an epidemic of distress-related mental disorders such as depression, while simultaneously necessitating a shift to virtual domains of mental health care; yet, the evidence to support the use of virtual interventions is unclear. Objective: The purpose of this study was to evaluate the efficacy of virtual interventions for depressive disorders by addressing three key questions: (1) Does virtual intervention provide better outcomes than no treatment or other control conditions (ie, waitlist, treatment as usual [TAU], or attention control)? (2) Does in-person intervention provide better outcomes than virtual intervention? (3) Does one type of virtual intervention provide better outcomes than another? Methods: We searched the PubMed, EMBASE, and PsycINFO databases for trials published from January 1, 2010, to October 30, 2021. We included randomized controlled trials of adults with depressive disorders that tested a virtual intervention and used a validated depression measure. Primary outcomes were defined as remission (ie, no longer meeting the clinical cutoff for depression), response (ie, a clinically significant reduction in depressive symptoms), and depression severity at posttreatment. Two researchers independently selected studies and extracted data using PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Risk of bias was evaluated based on Agency for Healthcare and Research Quality guidelines. We calculated odds ratios (ORs) for binary outcomes and standardized mean differences (SMDs) for continuous outcomes. Results: We identified 3797 references, 24 of which were eligible. Compared with waitlist, virtual intervention had higher odds of remission (OR 10.30, 95% CI 5.70-18.60; N=619 patients) and lower posttreatment symptom severity (SMD 0.81, 95% CI 0.52-1.10; N=1071). Compared with TAU and virtual attention control conditions, virtual intervention had higher odds of remission (OR 2.27, 95% CI 1.10-3.35; N=512) and lower posttreatment symptom severity (SMD 0.25, 95% CI 0.09-0.42; N=573). In-person intervention outcomes were not significantly different from virtual intervention outcomes (eg, remission OR 0.84, CI 0.51-1.37; N=789). No eligible studies directly compared one active virtual intervention to another. Conclusions: Virtual interventions were efficacious compared with control conditions, including waitlist control, TAU, and attention control. Although the number of studies was relatively small, the strength of evidence was moderate that in-person interventions did not yield significantly better outcomes than virtual interventions for depressive disorders. [ABSTRACT FROM AUTHOR]

Coronavirus disease 2019 (COVID‐19), mediated by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2), can manifest with flu‐like illness and severe pneumonia with acute respiratory distress syndrome (ARDS). Immunocompromised patients merit particular attention as altered host immunity may influence both disease severity and duration of viral shedding as is described with several other ribonucleic acid respiratory viruses. Yet immunocompromised status alone, in the absence of other comorbidities, may not necessarily predict severe illness presentations and poorer clinical outcomes as indicated by recent reports of COVID‐19‐infected solid organ transplant recipients and people living with human immunodeficiency virus (HIV). Such patients may even be spared the robust inflammatory response that precipitates ARDS associated with COVID‐19, complicating the management of iatrogenic immunosuppression in this setting. We present a case of an orthotopic liver transplant recipient with well‐controlled HIV who successfully recovered from a mild, flu‐like illness attributed to SARS‐CoV‐2. [ABSTRACT FROM AUTHOR]

Background: Infections are the most common cause of non‐relapse mortality in adult allogeneic hematopoietic stem cell transplant (allo HSCT) recipients. Acute gastrointestinal graft‐vs‐host disease (GI GVHD) often leads to friable mucosa as well as treatment interventions which can increase risk of infection. Our primary objective was to describe the relationship between increasing grades of acute GI GVHD and incidence of bloodstream infections (BSI). Methods: We reviewed 441 adults who underwent allo HSCT from 2011 to 2017 and were clinically diagnosed with GI GVHD, non‐GI GVHD, or no GVHD based on the modified Glucksberg scale within the first 100 days of transplantation. The maximum grades of acute GI GVHD and non‐GI GVHD were used in the analysis. BSI was defined based on the presence of a blood culture positive for bacteria or fungi and treatment with antibiotics. The incidence of BSI within the first 180 days of transplantation was estimated with the cumulative incidence method. Fine and Gray regression was used to assess association between clinical grade of acute GI GVHD and BSI risk, adjusting for grade of non‐GI GVHD and for other significant baseline patient risk factors for BSI identified by multivariable analysis. Results are shown as hazard ratio (HR) and 95% confidence interval (CI). A similar analysis was conducted in 130 patients with histologic grade of acute GI GVHD. Results: Overall BSI incidence by day 180 was 32%; gram‐negative bacilli were the predominant organisms, followed by gram‐positive cocci and fungi. Patients with grade 4 acute GI GVHD had higher risk of BSI as compared to patients with no GI GVHD (HR 2.98, CI 1.65‐5.37, P <.001), while those with grade 3 acute GI GVHD had similar BSI risk (HR 0.89, CI 0.36‐2.21, P =.81). Grade of GI GVHD had no association with risk of non‐BSI. Results were similar in patients with histologic grade acute GI GVHD. Patients who developed BSI or non‐BSI had significantly higher overall mortality risk compared to those without infectious complications (HR 2.52, CI 1.92‐3.31, P <.001 for BSI; HR 1.60, CI 1.20‐2.13, P =.001 for non‐BSI). Conclusions: Grade 4 acute GI GVHD is associated with a higher risk of BSI, which is in turn associated with a higher risk of overall mortality in this population. Understanding the relationships between acute GI GVHD, BSI, and overall mortality can guide future treatment strategies for adult allo HSCT recipients. [ABSTRACT FROM AUTHOR]

Background Infections are the most common cause of non-relapse mortality in adult allogeneic stem cell transplant (allo SCT) recipients. Acute gastrointestinal graft-vs.-host disease (GI GVHD) often leads to friable mucosa and interventions increasing infectious risk. We describe the relationships between increasing grades of acute GI GVHD and incidence of bloodstream infections (BSI) at our institution. Methods We reviewed 441 adults who underwent allo SCT from 2011 to 2017 and were diagnosed with GI GVHD, non-GI GVHD, or no GVHD based on the Modified Glucksberg Scale within the first 100 days of transplant. The maximum grades of GI GVHD and non-GI GVHD were used in the analysis. A BSI episode constituted a blood culture positive for bacteria or fungi and antibiotic treatment. The incidence of BSI within the first 180 days of transplantation was estimated with the cumulative incidence method. Results Overall BSI incidence by day 180 was 32%; Gram-negative bacilli were the predominant organisms. Adjusting for grade of non-GI GVHD, patients with acute grade 4 GI GVHD had higher risk of BSI as compared with patients with no GI GVHD (HR 3.02, P < 0.001), while those with grade 3 GI GVHD had similar risk (HR 1.01, P = 0.98). Patients with grade 1 or 2 GI GVHD demonstrated lower BSI risk compared with those with no GI GVHD (HR 0.48, P = 0.015; HR 0.44, P = 0.08, respectively). Results were similar after adjusting for patient- and transplant-related risk factors for BSI. Grade of GI GVHD had no association with non-BSI risk. Patients who developed BSI or non-BSI had significantly higher overall mortality risk compared with those without infectious complications (HR 2.52, P < 0.001 for BSI; HR 1.60, P = 0.001 for non-BSI). Conclusion Acute grade 4 GI GVHD may reliably indicate higher BSI and overall mortality risk in this population. Understanding the relationships between acute GI GVHD and BSI can guide future treatment strategies for adult allo SCT recipients. Disclosures All authors: No reported disclosures. [ABSTRACT FROM AUTHOR]

Background: Antibiotic allergy de‐labeling using penicillin allergy skin testing (PAST) can reduce the use and cost of alternative, non‐β‐lactam antibiotics in general inpatient populations. This strategy's role in hematopoietic stem cell transplant (HSCT) recipients is unclear. Methods: This study aimed to determine the effect of a pre‐transplant PAST protocol on antibiotic use, days of therapy (DOT), and cost in an immunocompromised population at a single center from 7/1/2010‐2/1/2019. Patients who received chimeric antigen receptor (CAR) T‐cell therapy and those who underwent transplantation in the outpatient setting were excluded. Results: Of 1560 patients who underwent inpatient HSCT during the study period, 208 reported β‐lactam allergy (136/844 [16%] pre‐ and 72/716 [10%] post‐implementation; P <.001). PAST was performed on 7% and 54% of HSCT recipients pre‐ and post‐implementation, respectively. Only two positive PAST were noted. There were no adverse reactions to PAST. There were no significant differences in the disease and transplant characteristics between the two groups. Days of therapy and cost of alternative antibiotics significantly decreased post‐implementation (mean 788 vs 627 days, P =.01; mean $24 425 vs $17 518, P =.009). Conclusion: Penicillin allergy skin testing adjudicates reported β‐lactam allergy in HSCT recipients, lowering use, DOT, and cost of alternative antibiotics and promoting effective formulary agents to treat immunocompromised HSCT recipients. [ABSTRACT FROM AUTHOR]

Background Clostridium difficile infection (CDI) is the leading cause of infectious diarrhea in the healthcare setting. Solid-organ transplant (SOT) recipients are at increased risk compared with the general hospitalized population (7.4–20% vs. 0.9%). Our center recently expanded its intestinal and multivisceral transplant (IMVT) program, providing the opportunity to examine the epidemiology of CDI in this vulnerable population. Methods We conducted a retrospective study of all IMVT recipients between 2009 and 2018. CDI was defined as presence of diarrhea with a positive polymerase chain reaction (PCR) test for the toxin B gene. Early CDI constituted an episode of CDI within the first 6 months post-transplant. Data were collected on demographics, transplant characteristics, CDI episode, and outcomes. Results We identified 86 patients who underwent a total of 94 transplants: 60 (64%) isolated intestinal transplants, 21 (22%) intestine/liver/pancreas, 10 (11%) intestine/pancreas, two (2%) intestine/liver/pancreas/kidney, and one (1%) intestine/kidney transplant. All but three patients received perioperative metronidazole. Four patients (5%) had CDI prior to transplant, but none of them recurred in the first 6 months post-transplant. Five patients developed a total of seven mild-moderate episodes of early CDI (attack rate = 5.9%). Three patients (60%) with early CDI developed rejection, similar to the incidence (70%) in patients without CDI. Two patients with early CDI developed recurrence; both underwent intestinal re-transplantation. One-year mortality was similar among patients with and without early CDI (20% vs. 23%). Conclusion CDI is associated with allograft loss, rejection, and mortality in some SOT recipients. Although limited by sample size, we observed that early CDI was not associated with those outcomes in our population. Multicenter studies are merited to explore risk factors for CDI and associations with outcomes in IMVT. Disclosures All authors: No reported disclosures. [ABSTRACT FROM AUTHOR]

The emergence of groundbreaking clinical targets and treatment modalities is fueling a surge in the number of clinical trials. This increased volume, coupled with the growing complexity of trials, is putting immense pressure on medicine's development process. One immediate area of opportunity for streamlining clinical trials is clinical and regulatory medical writing. Generative AI (GenAI) has the potential to revolutionize medical writing by automating routine tasks, improving consistency and quality, and enabling faster turnaround times. This frees medical writers from mundane work, allowing them to focus on strategic initiatives and exert greater influence within life sciences organizations. This article explores the current state of clinical and regulatory medical writing, the challenges posed by the increasing complexity of clinical trials, and how GenAI can be used to address these challenges. The article also discusses the ethical considerations of using GenAI in medical writing and the importance of human oversight and review. Overall, the article builds a compelling case for the use of GenAI in medical writing and outlines a roadmap for the future of this field. [ABSTRACT FROM AUTHOR]