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Immunosuppression is a critical aspect of post-transplant management, yet practices at intermediate and late time points after liver transplantation (LT) are poorly characterized.A retrospective cohort of 11 326 adult first LT alone recipients between 2007 and 2016 was identified by linking United Network for Organ Sharing transplant data to Medicare administrative claims. The immunosuppression regimen was obtained from Medicare billing claims. Factors associated with calcineurin inhibitor (CNI) monotherapy at 1-, 3-, and 5-y post-LT were investigated using mixed-effects logistic regression. Center practice heterogeneity was evaluated. The association of immunosuppression regimen (time-updating) with patient and graft survival was studied.CNI monotherapy was used in 51.9% at 1-y post-LT and 68.6% at 5-y post-LT. Center-specific rates ranged from 20.0%-79.9% to 15.4%-95.2%, respectively. CNI monotherapy at 1- and 3-y post-LT was less likely among Black recipients ( P = 0.027 and P = 0.015 versus White, respectively). CNI plus antimetabolite was associated with improved adjusted patient (hazard ratio, 0.59; P0.001) and graft (hazard ratio, 0.62; P0.001) survival versus CNI monotherapy. The benefit of CNI plus antimetabolite on patient and graft survival increased with older age.In this first longitudinal analysis of LT immunosuppression practices among Medicare beneficiaries, a CNI plus antimetabolite approach led to improved outcomes. Significant center heterogeneity in practice was observed.

Many patients with Crohn's disease (CD) lose response or become intolerant to antitumor necrosis factor (TNF) therapy and subsequently switch out of class. We compared the effectiveness and safety of ustekinumab to vedolizumab in a large, geographically diverse US population of TNF-experienced patients with CD.We conducted a retrospective cohort study using longitudinal claims data from a large US insurer (Anthem, Inc.). We identified patients with CD initiating vedolizumab or ustekinumab with anti-TNF treatment in the prior 6 months. Our primary outcome was treatment persistence for52 weeks. Secondary outcomes included (i) all-cause hospitalization, (ii) hospitalization for CD with surgery, (iii) hospitalization for CD without surgery, and (iv) hospitalization for infection. Propensity score fine stratification was used to control for demographic and baseline clinical characteristics and prior treatments.Among 885 new users of ustekinumab and 490 new users of vedolizumab, we observed no difference in treatment persistence (adjusted risk ratio 1.09 [95% confidence interval 0.95-1.25]). Ustekinumab was associated with a lower rate of all-cause hospitalization (adjusted hazard ratio 0.73 [0.59-0.91]), nonsurgical CD hospitalization (adjusted hazard ratio 0.58 [0.40-0.83]), and hospitalization for infection (adjusted hazard ratio 0.56 [0.34-0.92]).This real-world comparative effectiveness study of anti-TNF-experienced patients with CD initiating vedolizumab or ustekinumab showed similar treatment persistence rates beyond 52 weeks, although secondary outcomes such as all-cause hospitalizations, nonsurgical CD hospitalizations, and hospitalizations for infection favored ustekinumab initiation. We, therefore, advocate for individualized decision making in this medically refractory population, considering patient preference and other factors such as cost and route of administration.

Let $X/{\mathbb C}$ be a smooth projective variety. We consider two integral invariants, one of which is the level of the Hodge cohomology algebra $H^*(X,{\mathbb C})$ and the other involving the complexity of the higher Chow groups ${\mathrm {CH}}^*(X,m;{\mathbb Q})$ for $m\geq 0$ . We conjecture that these two invariants are the same and accordingly provide some strong evidence in support of this.

Malnutrition is associated with poor outcomes in hospitalized adults. We aimed to assess the effectiveness of hospital-initiated interventions for patients with malnutrition.Data sources included MEDLINE, Embase, Cochrane Library from January 1, 2000 to June 3, 2021. We included randomized controlled trials (RCTs) assessing interventions for hospitalized adults diagnosed or identified as at-risk for malnutrition using malnutrition screening and diagnostic assessment tools. Individual reviewers extracted study data and performed quality checks for accuracy. Meta-analysis was conducted using a random-effects model with variance correction. We assessed the overall strength of evidence at the outcome level. The risk of bias was assessed using the Cochrane Risk of Bias 2.0 tool.We found 11 RCTs that assessed two types of interventions: specialized nutrition care (8 RCTs) and increased protein provision (3 RCTs). The pooled findings of 11 RCTs found moderate strength of evidence that specialized nutrition care and increased protein provision reduced mortality by 21% (relative risk [RR]: 0.79, 95% confidence interval [CI]: 0.63-0.98; absolute risk reduction [ARR]: -0.02, 95% CI: -0.03 to -0.00). Pooled estimates indicated a nonsignificant decrease of 0.18 days in the length of stay (9 RCTs) and a 10% reduction in readmissions (7 RCTs). No eligible RCTs assessed parenteral or enteral nutrition.Certain malnutrition-focused hospital-initiated interventions (e.g., specialized nutrition care and increased protein provision) reduce mortality and may improve the quality of life among patients at risk for or diagnosed with malnutrition. Future trials are needed to assess the effectiveness of parenteral and enteral nutrition.

Background & Aims Laboratory studies have demonstrated that antibiotic use in conjunction with bowel purgatives causes alterations to the gut microbiota. Because gut microbiota changes may be a trigger for the development of irritable bowel syndrome (IBS), we sought to assess whether individuals who undergo bowel cleansing for colonoscopy and have concurrent antibiotic exposure develop IBS at higher rates than individuals who undergo colonoscopy without antibiotic exposure. Methods We used data from Optum’s de-identified Clinformatics Data Mart Database in the United States to study a cohort of 50- to 55-year-olds who underwent screening colonoscopy. Individuals exposed to antibiotics within 14 days of colonoscopy were propensity-score matched to individuals who were not exposed to antibiotics around colonoscopy. The primary outcome was a new IBS diagnosis, and the composite outcome was a new claim for IBS, IBS medications, or IBS symptoms. The association of antibiotic exposure and the outcomes was calculated using Cox proportional hazards regression. Results There were 408,714 individuals who met criteria for the screening colonoscopy cohort. Of these, 24,617 (6.0%) were exposed to antibiotics around the time of colonoscopy, and they were propensity-score matched to 24,617 individuals not exposed to antibiotics. There was no statistically significant association between antibiotic use and IBS (hazard ratio, 1.11; 95% confidence interval, 0.89–1.39), but there was a weak association between antibiotic use and the composite outcome (hazard ratio, 1.12; 95% confidence interval, 1.02–1.24; number needed to harm, 94). Conclusions Individuals concurrently exposed to antibiotics and bowel purgative had slightly higher rates of surrogate IBS outcomes compared with matched controls who did not receive antibiotics concurrently with bowel purgative.

Background To facilitate inflammatory bowel disease (IBD) research in the United States, we developed and validated claims-based definitions to identify incident and prevalent IBD diagnoses using administrative healthcare claims data among multiple payers. Methods We used data from Medicare, Medicaid, and the HealthCore Integrated Research Database (Anthem commercial and Medicare Advantage claims). The gold standard for validation was review of medical records. We evaluated 1 incidence and 4 prevalence algorithms based on a combination of International Classification of Diseases codes, National Drug Codes, and Current Procedural Terminology codes. The claims-based incident diagnosis date needed to be within ±90 days of that recorded in the medical record to be valid. Results We reviewed 111 charts of patients with a potentially incident diagnosis. The positive predictive value (PPV) of the claims algorithm was 91% (95% confidence interval [CI], 81%-97%). We reviewed 332 charts to validate prevalent case definition algorithms. The PPV was 94% (95% CI, 86%-98%) for ≥2 IBD diagnoses and presence of prescriptions for IBD medications, 92% (95% CI, 85%-97%) for ≥2 diagnoses without any medications, 78% (95% CI, 67%-87%) for a single diagnosis and presence of an IBD medication, and 35% (95% CI, 25%-46%) for 1 physician diagnosis and no IBD medications. Conclusions Through a combination of diagnosis, procedural, and medication codes in insurance claims data, we were able to identify incident and prevalent IBD cases with high accuracy. These algorithms can be useful for the ascertainment of IBD cases in future studies.

Studies on outcomes in bladder cancer rely on accurate methods to identify patients with bladder cancer and differentiate bladder cancer stage. Medical record and administrative databases are increasingly used to study cancer incidence, but few have distinguished cancer stage, and none have focused on bladder cancer. In this study, we used data from The UK Health Improvement Network (THIN) to identify patients with bladder cancer using at least one diagnostic code for bladder cancer, and distinguish muscle-invasive from non-invasive disease using a subsequent code for cystectomy. Algorithms were validated against a gold standard of physician-completed questionnaires, pathology reports, and consultant letters. Algorithm performance was evaluated by measuring positive predictive value (PPV) and corresponding 95% confidence interval (CI). Among all patients coded with bladder cancer (n = 194), PPV for any bladder cancer was 99.5% (95% CI, 97.2–99.9). PPV for incident bladder cancer was 93.8% (95% CI, 89.4–96.7). PPV for muscle-invasive bladder cancer was 70.1% (95% CI, 59.4–79.5) in patients with cystectomy (n = 95) and 83.9% (95% CI, 66.3–94.5) in those with cystectomy plus additional codes for metastases and death (n = 31). Using our codes for bladder cancer, the age- and sex-standardized incidence rate (SIR) of bladder cancer in THIN approximated that measured by cancer registries (SIR within 20%), suggesting that sensitivity was high as well. THIN is a valid and novel database for the study of bladder cancer. Our algorithm can be used to examine the epidemiology of muscle-invasive bladder cancer or outcomes following cystectomy for patients with muscle invasion. Cancer Epidemiol Biomarkers Prev; 24(1); 303–7. ©2014 AACR.

Supplementary Figure 1. Mailed questionnaire to general practitioner ; Supplementary Figure 2. Standardized incidence ratios (SIRs) for bladder cancer in THIN 2000-2011; Supplementary Table 1. Bladder cancer and cystectomy codes; Supplementary Table 2. Algorithm performance for detecting incident bladder cancer; Supplementary Table 3. Computation of the proportion of muscle-invasive bladder cancer that is captured by the algorithm for muscle-invasion among those with coded bladder cancer diagnosis in THIN

OBJECTIVE To assess the association of sodium–glucose cotransporter 2 (SGLT2) inhibitors with diabetic ketoacidosis compared with dipeptidyl peptidase 4 (DPP-4) inhibitors and sulfonylureas in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS We conducted a new-user active comparator cohort study to examine two pairwise comparisons: 1) SGLT2 inhibitors versus DPP-4 inhibitors and 2) SGLT2 inhibitors versus sulfonylureas. The main outcome was diabetic ketoacidosis present on hospital admission. We adjusted for confounders through propensity score matching. We used Cox proportional hazards regression with a robust variance estimator to estimate hazard ratios (HRs) and corresponding 95% CIs while adjusting for calendar time. RESULTS In cohort 1 (n = 85,125 for SGLT2 inhibitors and n = 85,125 for DPP-4 inhibitors), the incidence rates of diabetic ketoacidosis per 1,000 person-years were 6.0 and 4.3 for SGLT2 inhibitors and DPP4 inhibitors, respectively. In cohort 2 (n = 72,436 for SGLT2 inhibitors and n = 72,436 for sulfonylureas), the incidence rates of diabetic ketoacidosis per 1,000 person-years were 6.3 and 4.5 for SGLT2 inhibitors and sulfonylureas, respectively. In Cox proportional hazards regression models, the use of SGLT2 inhibitors was associated with a higher rate of diabetic ketoacidosis compared with DPP-4 inhibitors (adjusted HR [aHR] 1.63; 95% CI 1.36, 1.96) and sulfonylureas (aHR 1.56; 95% CI 1.30, 1.87). CONCLUSIONS In this comparative safety study using real-world data, patients with type 2 diabetes who were newly prescribed SGLT2 inhibitors had a higher rate of diabetic ketoacidosis compared with DPP-4 inhibitors and sulfonylureas. Clinicians should be vigilant about this association.

Apixaban and rivaroxaban are replacing vitamin K antagonists for the treatment of venous thromboembolism (VTE) in adults; however, head-to-head comparisons remain limited.To assess the effectiveness and safety of apixaban compared with rivaroxaban in patients with VTE.Retrospective new-user cohort study.U.S.-based commercial health care insurance database from 1 January 2015 to 30 June 2020.Adults with VTE who were newly prescribed apixaban or rivaroxaban.The primary effectiveness outcome was recurrent VTE, a composite of deep venous thrombosis and pulmonary embolism. The primary safety outcome was a composite of gastrointestinal and intracranial bleeding.Of 49 900 eligible patients with VTE, 18 618 were new users of apixaban and 18 618 were new users of rivaroxaban. Median follow-up was 102 days (25th, 75th percentiles: 30, 128 days) among apixaban and 105 days (25th, 75th percentiles: 30, 140 days) among rivaroxaban users. After propensity score matching, apixaban (vs. rivaroxaban) was associated with a lower rate for recurrent VTE (hazard ratio, 0.77 [95% CI, 0.69 to 0.87]) and bleeding (hazard ratio, 0.60 [CI, 0.53 to 0.69]). The absolute reduction in the probability of recurrent VTE with apixaban versus rivaroxaban was 0.006 (CI, 0.005 to 0.011) within 2 months and 0.011 (CI, 0.011 to 0.013) within 6 months of initiation. The absolute reduction in the probability of gastrointestinal and intracranial bleeding with apixaban versus rivaroxaban was 0.011 (CI, 0.010 to 0.011) within 2 months and 0.015 (CI, 0.013 to 0.015) within 6 months of initiation.Short follow-up.In this population-based cohort study, patients with VTE who were new users of apixaban had lower rates for recurrent VTE and bleeding than new users of rivaroxaban.None.

Some gastrointestinal conditions now have diet as a cornerstone to therapy. Three examples include the low-fermentable, oligosaccharide, disaccharide, monosaccharide, and polyol diet for irritable bowel syndrome, a gluten-free diet for celiac disease, and a hypoallergenic diet for eosinophilic esophagitis. All have been shown to be effective in Western or highly industrialized countries. However, these gastrointestinal conditions occur worldwide. Less is known regarding the effectiveness of dietary therapies in cultures and regions of dense religious and traditional practices where food is a central focus. This includes South Asia, the Mediterranean region, Africa, the Middle East, South America, and within Indigenous communities. Hence, there is a need to reproduce dietary intervention studies within cultures of dense traditional dietary practices to understand the applicability and acceptability of dietary therapy to establish generalizability. Furthermore, there is a need for nutrition experts to have a deep understanding of various cultural cuisines, practices, values, and customs. To achieve this, increasing the diversity of students in the sciences and having a diverse workforce of nutrition experts and health professionals that reflects the patient population will allow for more personalized care. In addition, there are social challenges, including a lack of medical insurance coverage, the cost of dietary interventions, and inconsistent nutrition messaging. Although there are many cultural considerations and social challenges to implementing effective dietary interventions around the world, these barriers are addressable through research methodologies that address culture and society challenges, and enhanced training of dietitians.

Marla C Dubinsky,1 Louise Newton,2 Laure Delbecque,3 Theresa Hunter,4 Aiste Guobyte,5 April N Naegeli,4 Shehan McFadden,5 Jill Donaldson,6 Tara Symonds,2 James D Lewis7 1Icahn School of Medicine, Mount Sinai, NY, USA; 2Clinical Outcomes Solutions, Folkestone, UK; 3Eli Lilly and Company, Brussels, Belgium; 4Eli Lilly and Company, Indianapolis, IN, USA; 5Clinical Outcomes Solutions, Chicago, IL, USA; 6Crohn’s and Colitis Foundation, New York, NY, USA; 7Perelman School of Medicine, Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, PA, USACorrespondence: Laure Delbecque, Principal Research Scientist, Eli Lilly and Company, Brussels, Belgium, Tel +32 (0)499 72 31 37, Email delbecque_laure@lilly.comPurpose: Achieving and maintaining symptom control is a key treatment goal in ulcerative colitis (UC). Bowel urgency is an important symptom of UC, thus measurement of urgency is critical. This research explored the patient experience of UC and “remission” in UC, with a focus on urgency, and cognitively debriefed the Urgency Numeric Rating Scale (NRS), including score interpretation and examination of meaningful improvement.Patients and Methods: Semi-structured hybrid concept elicitation and cognitive debriefing interviews with adults with moderately-severely active UC were conducted to explore experiences of UC and urgency, as well as examine meaningful improvement and score interpretation of the Urgency NRS. Purposive sampling was used to identify 20 eligible adult participants with UC. Concept elicitation data were analyzed using thematic analysis, and a deductive approach was used to analyze cognitive debriefing data. Thematic analysis was also applied to meaningful change-related data.Results: Twenty participants were interviewed (average age = 42.6 years old, 50% male); 14 with moderately active (70.0%) and 6 with severely active UC (30.0%). Disease remission was not consistently defined by participants and description varied in terms of definition (absence vs not complete absence of symptoms), duration (months vs days) and key symptoms to consider. Urgency was a prominent symptom for all participants, with 8 (40.0%) identifying it as the most bothersome aspect of UC. No issues were identified with the Urgency NRS. Participants were able to define different levels of urgency severity, describe how they relate to daily life impacts, and score them differently on the Urgency NRS. Participants were also able to reflect urgency improvement on the NRS and discuss how small changes in numeric ratings of urgency can reflect meaningful change in the symptom burden of their UC.Conclusion: The Urgency NRS is a content valid and interpretable measure to assess bowel urgency severity.Keywords: ulcerative colitis, qualitative, bowel urgency, content validity

ImportanceBariatric surgery procedures, in particular Roux-en-Y gastric bypass (RYGB), have been associated with subsequent alcohol-related complications. However, previous studies lack data to account for changes in body mass index (BMI) or alcohol use over time, which are key potential confounders.ObjectiveTo evaluate the association between RYGB, sleeve gastrectomy, or gastric banding on subsequent alcohol use disorder (AUD)–related hospitalization and all-cause mortality as compared with referral to a weight management program alone.Design, Setting, and ParticipantsThis cohort study included 127 Veterans Health Administration health centers in the US. Patients who underwent RYGB, sleeve gastrectomy, or gastric banding or who were referred to MOVE!, a weight management program, and had a BMI (calculated as weight in kilograms divided by height in meters squared) of 30 or greater between January 1, 2008, and December 31, 2021, were included in the study.ExposuresRYGB, sleeve gastrectomy, or gastric banding or referral to the MOVE! program.Main Outcomes and MeasuresThe primary outcome was time to AUD-related hospitalization from the time of bariatric surgery or MOVE! referral. The secondary outcome was time to all-cause mortality. Separate propensity scores were created for each pairwise comparison (RYGB vs MOVE! program, RYGB vs sleeve gastrectomy, sleeve gastrectomy vs MOVE!). Sequential Cox regression approaches were used for each pairwise comparison to estimate the relative hazard of the primary outcome in unadjusted, inverse probability treatment weighting (IPTW)–adjusted (generated from the pairwise logistic regression models), and IPTW-adjusted approaches with additional adjustment for time-updating BMI and categorical Alcohol Use Disorders Identification Test-Concise scores.ResultsA total of 1854 patients received RYGB (median [IQR] age, 53 [45-60] years; 1294 men [69.8%]), 4211 received sleeve gastrectomy (median [IQR] age, 52 [44-59] years; 2817 men [66.9%]), 265 received gastric banding (median [IQR] age, 55 [46-61] years; 199 men [75.1%]), and 1364 were referred to MOVE! (median [IQR] age, 59 [49-66] years; 1175 men [86.1%]). In IPTW Cox regression analyses accounting for time-updating alcohol use and BMI, RYGB was associated with an increased hazard of AUD-related hospitalization vs MOVE! (hazard ratio [HR], 1.70; 95% CI, 1.20-2.41; P = .003) and vs sleeve gastrectomy (HR, 1.98; 95% CI, 1.55-2.53; P P = .08). While RYGB was associated with a reduced mortality risk vs MOVE! (HR, 0.63; 95% CI, 0.49-0.81; P Conclusions and RelevanceThis cohort study found that RYGB was associated with an increased risk of AUD-related hospitalizations vs both sleeve gastrectomy and the MOVE! program. The mortality benefit associated with RYGB was diminished by increased alcohol use, highlighting the importance of careful patient selection and alcohol-related counseling for patients undergoing this procedure.

The objective of the study was to quantify inter-subject variability in the dependence of the medial-olivocochlear reflex (MOCR) on noise bandwidth. Of specific interest was whether inter-subject variability in MOCR dependence on bandwidth explained variability in the MOCR response elicited by wideband noise.Thirty-two young adults with normal hearing participated in the study. Click-evoked otoacoustic emissions were measured in the ipsilateral ear with and without noise presented in the contralateral ear. Presentation of contralateral noise served to activate the MOCR. The MOCR was activated using five different noise stimuli with bandwidths ranging from 1- to 5-octaves wide (center frequency of 2 kHz; bandwidth incremented in 1-octave steps). Noise spectral levels (19.6 dB SPL/Hz) were held constant across all bandwidths. MOCR metrics included the normalized-percent change in the otoacoustic emission (OAE), the MOCR-induced OAE magnitude shift, and the MOCR-induced OAE phase shift. Linear mixed-effect models were fit to model the dependence of MOCR-induced OAE magnitude and phase changes on noise bandwidth. The use of a mixed-effect modeling approach allowed for the estimation of subject-specific model parameters that capture on- and off-frequency contributions to the MOCR effects. Regression analysis was performed to evaluate the predictive capacity of subject-specific model parameters on the MOCR response elicited by wideband noise.All OAE-based MOCR metrics increased as the noise bandwidth increased from 1- to 5-octaves wide. The dependence of MOCR-induced OAE magnitude and phase shifts on activator bandwidth was well approximated using a linear model with intercept and slope terms. On average, MOCR-induced magnitude and phase shifts increased at a rate of 0.3 dB/octave and 0.01 cycles/octave, respectively, as bandwidth extended beyond the predicted region of OAE generation. A statistically significant random effect of subject was found for both the intercept and slope parameter of each model. Subject-specific slope estimates were statistically significant predictors of a repeated measure of the wideband MOCR response. A higher slope was predictive of larger wideband MOCR effects.MOCR-induced changes to the OAE are greatest when the MOCR is elicited using wideband noise. Variability in the process of spectral integration within the MOCR pathway appears to explain, in part, inter-subject variability in OAE-based estimates of the MOCR response elicited by wideband noise.

OBJECTIVES The objective of this study was to evaluate the influence of music versus speech on a listener's signal-to-noise ratio (SNR) preferences when listening in a noise background. SNR preferences were quantified using acceptable noise level (ANL) and preferred SNR metrics. The measurement paradigm for ANL allows the listener to adjust the level of background noise while listening to the target at their most comfortable loudness level. A higher ANL indicates less tolerance for noise and a lower ANL indicates high tolerance for noise. The preferred SNR is simply the SNR the listener prefers when attending to a target in a fixed-amount (level) of background noise. In contrast to the ANL, the listener does not have control over the noise. Rather, they are only able to manipulate the target level. The first aim of the study was to determine if listeners' tolerances for noise, quantified using the ANL, when listening to music is different from that when listening to speech. The second aim of the study was to determine if listeners' tolerances for noise, quantified using their preferred SNR, when listening to music is different from that when listening to speech. The third aim of the study was to quantify the relationship between ANL and preferred SNR. DESIGN Ninety-nine normal-hearing, native-English speakers participated in this study. The ANL and preferred SNR were measured for speech and music targets. Music targets included two variations (with lyrics and without lyrics) of the song "Rocky Top." Measurements were made in the sound field at 0° azimuth, 1.5 m from a loud speaker. For both ANL and preferred SNR, targets were presented in 12-talker babble noise. The level of the noise was adjusted by the listener during ANL measurement but was fixed in level during the preferred SNR measurement (75 dB A). Repeated-measures analysis of variance was performed to identify any significant effect of target on the ANL and preferred SNR. Correlation analysis was performed to evaluate the relationship between ANL and preferred SNR. RESULTS Findings demonstrate a significant effect of target on ANL and preferred SNR. ANLs were highest for speech (mean = 7.2 dB), followed by music with lyrics (6.1 dB), and music without lyrics (2.5 dB). Preferred SNRs were highest for music with lyrics (mean = 2.3 dB), followed by speech (1.2 dB), and music without lyrics (-0.1 dB). A listener's ANL for a given target was strongly correlated with their ANL for a different target (the same was true for preferred SNR); however, ANL for a given target was not a statistically significant predictor of preferred SNR for the same target. CONCLUSIONS When listening in a background of noise, the listener's tolerance for noise depends on the target to which they are attending, whether music or speech. This dependence is especially evident for ANL measures, and less so for preferred SNR measures. Despite differences in ANL and preferred SNR across targets, a listener's ANL and preferred SNR for one target predicts their ANL and preferred SNR, respectively, for a different target. The lack of correlation between ANL and preferred SNR suggests different mechanisms underly these listener-preference metrics.

Although apixaban and rivaroxaban are commonly used in patients with atrial fibrillation (AF) and valvular heart disease (VHD), there is limited evidence comparing the 2 drugs in these patients.To emulate a target trial of effectiveness and safety of apixaban and rivaroxaban in patients with AF and VHD.New-user, active comparator, cohort study design.Commercial health insurance database from 1 January 2013 to 31 December 2020.New users of apixaban or rivaroxaban who had a diagnosis of AF and VHD before initiation of anticoagulant therapy.The primary effectiveness outcome was a composite of ischemic stroke or systemic embolism. The primary safety outcome was a composite of gastrointestinal or intracranial bleeding. Cox proportional hazards regression with a robust variance estimator was used to estimate hazard ratios (HRs) and 95% CIs.When compared with rivaroxaban in a propensity score-matched cohort of 19 894 patients (9947 receiving each drug), apixaban was associated with a lower rate of ischemic stroke or systemic embolism (HR, 0.57 [95% CI, 0.40 to 0.80]) and bleeding (HR, 0.51 [CI, 0.41 to 0.62]). The absolute reduction in the probability of stroke or systemic embolism with apixaban compared with rivaroxaban was 0.0026 within 6 months and 0.011 within 1 year of treatment initiation. The absolute reduction in the probability of bleeding events with apixaban compared with rivaroxaban was 0.012 within 6 months and 0.019 within 1 year of treatment initiation.Short follow-up time and inability to ascertain some types of VHD.In this study of patients with AF and VHD, patients receiving apixaban had a lower risk for ischemic stroke or systemic embolism and for bleeding when compared with those receiving rivaroxaban.National Institutes of Health.

Background and aims Nutritional therapy with the Crohn’s Disease Exclusion Diet + Partial Enteral Nutrition [CDED+PEN] or Exclusive Enteral Nutrition [EEN] induces remission and reduces inflammation in mild-to-moderate paediatric Crohn’s disease [CD]. We aimed to assess if reaching remission with nutritional therapy is mediated by correcting compositional or functional dysbiosis. Methods We assessed metagenome sequences, short chain fatty acids [SCFA] and bile acids [BA] in 54 paediatric CD patients reaching remission after nutritional therapy [with CDED + PEN or EEN] [NCT01728870], compared to 26 paediatric healthy controls. Results Successful dietary therapy decreased the relative abundance of Proteobacteria and increased Firmicutes towards healthy controls. CD patients possessed a mixture of two metabotypes [M1 and M2], whereas all healthy controls had metabotype M1. M1 was characterised by high Bacteroidetes and Firmicutes, low Proteobacteria, and higher SCFA synthesis pathways, and M2 was associated with high Proteobacteria and genes involved in SCFA degradation. M1 contribution increased during diet: 48%, 63%, up to 74% [Weeks 0, 6, 12, respectively.]. By Week 12, genera from Proteobacteria reached relative abundance levels of healthy controls with the exception of E. coli. Despite an increase in SCFA synthesis pathways, remission was not associated with increased SCFAs. Primary BA decreased with EEN but not with CDED+PEN, and secondary BA did not change during diet. Conclusion Successful dietary therapy induced correction of both compositional and functional dysbiosis. However, 12 weeks of diet was not enough to achieve complete correction of dysbiosis. Our data suggests that composition and metabotype are important and change quickly during the early clinical response to dietary intervention. Correction of dysbiosis may therefore be an important future treatment goal for CD.

Patients with cirrhosis have increased risk of postoperative mortality. Several models have been developed to estimate this risk; however, current risk estimation scores cannot compare surgical risk with the risk of not operating.To identify clinical optimal thresholds to favor operative or nonoperative management for a common cirrhosis surgical scenario, the symptomatic abdominal hernia.This was a Markov cohort decision analytical modeling study evaluating elective surgery vs nonoperative management for a symptomatic abdominal hernia in a patient with cirrhosis. Transition probabilities and utilities were derived from the literature and from data using an established cirrhosis cohort in the Veterans Health Administration. Participants included patients who were referred to a surgery clinic for a symptomatic abdominal hernia. Data were obtained from patients diagnosed with cirrhosis between January 1, 2008 and December 31, 2018. Data were analyzed from January 1 to May 1, 2022.Expected quality-adjusted life-years (QALYs) were estimated for each pathway and iterated over baseline model for end-stage liver disease-sodium (MELD-Na) scores ranging from 6 to 25. Markov models were cycled over a 5-year time horizon.A total 2740 patients with cirrhosis (median [IQR] age, 62 [56-66] years; 2699 [98.5%] men) were referred to a surgery clinic for a symptomatic abdominal hernia; 1752 patients (63.9%) did not receive surgery. The median (IQR) follow-up was 42.1 (25.3-70.0) months. Using this cohort to estimate the mortality risk of operative and nonoperative pathways, an initial MELD-Na threshold of 21.3 points, below which surgery was associated with maximized QALYs was identified. Nonoperative management was associated with increased QALYs above this MELD-Na threshold. Although more patients experienced death with a surgical treatment decision across all initial MELD-Na values, this was counterbalanced by increased time spent in a resolved hernia state associated with increased utility. Model results were sensitive to the probability of hernia recurrence and hernia incarceration and utility decrement in the symptomatic hernia state.This decision analytical model study found that elective surgical treatment for a symptomatic abdominal hernia was favored even in the setting of relatively high MELD-Na scores. Patient symptoms, hernia-specific characteristics, and surgeon and center expertise may potentially impact the optimal strategy, emphasizing the importance of shared decision-making.

Background Clinical and molecular subcategories of inflammatory bowel disease (IBD) are needed to discover mechanisms of disease and predictors of response and disease relapse. We aimed to develop a study of a prospective adult research cohort with IBD (SPARC IBD) including longitudinal clinical and patient-reported data and biosamples. Methods We established a cohort of adults with IBD from a geographically diverse sample of patients across the United States with standardized data and biosample collection methods and sample processing techniques. At enrollment and at time of lower endoscopy, patient-reported outcomes (PRO), clinical data, and endoscopy scoring indices are captured. Patient-reported outcomes are collected quarterly. The quality of clinical data entry after the first year of the study was assessed. Results Through January 2020, 3029 patients were enrolled in SPARC, of whom 66.1% have Crohn’s disease (CD), 32.2% have ulcerative colitis (UC), and 1.7% have IBD-unclassified. Among patients enrolled, 990 underwent colonoscopy. Remission rates were 63.9% in the CD group and 80.6% in the UC group. In the quality study of the cohort, there was 96% agreement on year of diagnosis and 97% agreement on IBD subtype. There was 91% overall agreement describing UC extent as left-sided vs extensive or pancolitis. The overall agreement for CD behavior was 83%. Conclusion The SPARC IBD is an ongoing large prospective cohort with longitudinal standardized collection of clinical data, biosamples, and PROs representing a unique resource aimed to drive discovery of clinical and molecular markers that will meet the needs of precision medicine in IBD.

Cirrhosis poses an increased risk of postoperative mortality, yet it remains challenging to accurately risk stratify patients in clinical practice. The VOCAL-Penn cirrhosis surgical risk score was recently developed and internally validated in the national Veterans Affairs health system; however, to date this score has not been evaluated in independent cohorts. The goal of this study was to compare the predictive performance of the VOCAL-Penn to the Mayo risk, Model for End-Stage Liver Disease (MELD), and MELD-sodium (MELD-Na) scores in 2 large health systems. We performed a retrospective cohort study of patients with cirrhosis undergoing surgical procedures of interest at the Beth Israel Deaconess Medical Center or University of Pennsylvania Health System from January 1, 2008, to October 1, 2015. The outcomes of interest were 30-day and 90-day postoperative mortality. Concordance statistics (C-statistics), calibration curves, Brier scores, and the index of prediction accuracy (IPA) were compared for each predictive model. A total of 855 surgical procedures were identified. The VOCAL-Penn score had the numerically highest C-statistic for 90-day postoperative mortality (eg, 0.82 versus 0.79 Mayo versus 0.78 MELD-Na versus 0.79 MELD), although differences were not statistically significant. Calibrations were excellent for the VOCAL-Penn, MELD, and MELD-Na; however, the Mayo score consistently overestimated risk. The VOCAL-Penn had the lowest Brier score and highest IPA at both time points, suggesting superior overall predictive model performance. In subgroup analyses of patients with higher MELD scores, the VOCAL-Penn had significantly higher C-statistics compared with the MELD and MELD-Na. The VOCAL-Penn score (www.vocalpennscore.com) has excellent discrimination and calibration for postoperative mortality among diverse patients with cirrhosis. Overall performance is superior to the Mayo, MELD, and MELD-Na scores. In contrast to the MELD/MELD-Na, the VOCAL-Penn retains excellent discrimination among patients with higher MELD scores.

Background Direct oral anticoagulants (DOACs) are increasingly used in place of warfarin, but evidence about their effectiveness and safety in patients with valvular atrial fibrillation (AF) remains limited. Objective To assess the effectiveness and safety of DOACs compared with warfarin in patients with valvular AF. Design New-user retrospective propensity score-matched cohort study. Setting U.S.-based commercial health care database from 1 January 2010 to 30 June 2019. Participants Adults with valvular AF who were newly prescribed DOACs or warfarin. Measurements The primary effectiveness outcome was a composite of ischemic stroke or systemic embolism. The primary safety outcome was a composite of intracranial or gastrointestinal bleeding. Results Among a total of 56 336 patients with valvular AF matched on propensity score, use of DOACs (vs. warfarin) was associated with lower risk for ischemic stroke or systemic embolism (hazard ratio [HR], 0.64 [95% CI, 0.59 to 0.70]) and major bleeding events (HR, 0.67 [CI, 0.63 to 0.72]). The results for the effectiveness and safety outcomes remained consistent for apixaban (HRs, 0.54 [CI, 0.47 to 0.61] and 0.52 [CI, 0.47 to 0.57], respectively) and rivaroxaban (HRs, 0.74 [CI, 0.64 to 0.86] and 0.87 [CI, 0.79 to 0.96], respectively); with dabigatran, results were consistent for the major bleeding outcome (HR, 0.81 [CI, 0.68 to 0.97]) but not for effectiveness (HR, 1.03 [CI, 0.81 to 1.31]). Limitation Relatively short follow-up; inability to ascertain disease severity. Conclusion In this comparative effectiveness study using practice-based claims data, patients with valvular AF who were new users of DOACs had lower risks for ischemic stroke or systemic embolism and major bleeding than new users of warfarin. These data may be used to guide risk-benefit discussions regarding anticoagulant choices for patients with valvular AF. Primary funding source None.

Background Bowel urgency is commonly experienced by patients with ulcerative colitis (UC) and is associated with reduced health-related quality of life (QoL). Mirikizumab, a humanized monoclonal antibody directed against the p19 subunit of IL-23, significantly reduced bowel urgency in a double-blind, randomized, placebo-controlled Phase 2 clinical trial in patients with moderate-to-severe UC (NCT02589665). Methods All patients (N = 249) reported symptoms including absence or presence of bowel urgency. Absence of urgency was defined as no urgency for the 3 consecutive days prior to each scheduled visit. Missing urgency data were imputed as present. After 12 weeks of induction treatment, patients who achieved clinical response continued maintenance mirikizumab treatment through Week 52. We assessed the relationship of urgency with QoL, clinical outcomes, and inflammatory biomarkers at Weeks 12 and 52. Results Patients with absence of urgency demonstrated significantly greater improvement in Inflammatory Bowel Disease Questionnaire (IBDQ) scores even after adjusting for rectal bleeding (RB) and stool frequency (SF), significantly higher rates of all clinical outcomes at Weeks 12 and 52, and a greater decrease in inflammatory biomarkers C-reactive protein and fecal calprotectin compared to those with presence of urgency. Absence of urgency at Week 12 was associated with improved IBDQ scores at Week 52, while Week 12 RB or SF status was not. Conclusions Absence of urgency is strongly associated with improvement in QoL as well as clinical measures of UC disease activity. These findings suggest urgency may be a useful surrogate marker of disease activity and an important treatment target for UC.

BACKGROUND: Patients with recent hematopoietic cell transplantation (HCT) are considered high risk for gastrointestinal endoscopy due to the potential for procedural bacterial translocation. Prior studies investigating these risks do not account for the higher baseline rate of infectious complications among those who are immunocompromised. We performed a retrospective cohort study of patients with recent HCT who underwent endoscopy and their matched controls who did not undergo endoscopy. METHODS: We identified patients who underwent HCT followed by upper and/or lower endoscopy at the University of Pennsylvania from 2000 to 2018. Individuals were matched 1:1 by age, sex, and type of HCT to controls who underwent HCT without subsequent endoscopy. Infectious adverse events were assessed by Sepsis-3 and Sepsis-2 criteria. Factors associated with infectious adverse events after endoscopy/index date were assessed using multivariable conditional logistic regression. RESULTS: We identified 149 patients who underwent HCT and endoscopy and 149 matched controls who underwent HCT without endoscopy. Sepsis-3 infectious adverse events occurred in 3.4% of patients in each group. Sepsis-2 infectious adverse events occurred in 20.1% of patients who underwent endoscopy compared to 19.5% of controls. There was no association between endoscopy and Sepsis-2 infectious adverse events in the multivariable regression analysis (adjusted odds ratio 1.65, 95% CI 0.51–5.26). CONCLUSIONS: When compared to controls with similar immune statuses, patients who underwent endoscopy after HCT did not have a higher risk of infectious adverse events. These results may inform clinical decision making regarding the risks and benefits of endoscopic management after HCT.

Purpose Population-level studies on the treatment practices and comparative effectiveness of therapies in autoimmune hepatitis (AIH) are lacking due to the absence of validated methods to identify patients with AIH in large databases, such as administrative claims or electronic health records. This study ascertained the performance of International Classification of Diseases (ICD) codes for AIH, and developed and validated a novel algorithm that reliably identifies patients with AIH in health administrative data and claims. Methods This was a cross-sectional study of patients with ≥1 inpatient or ≥2 outpatient ICD codes for AIH between 2008 and 2019 at a single health system. In a random sample of 250 patients, definite or probable AIH was determined using the Simplified AIH score, Revised AIH score or expert adjudication. The positive predictive value (PPV) was obtained. Variations of this base algorithm were evaluated using additional criteria to increase its performance. Results Of the 250 patients, 143 (57.2%) patients had sufficient records available for review. The PPV of the base algorithm was 77.6% (95% CI: 69.9-84.2%). Exclusion of patients with ≥1 ICD code for primary biliary cholangitis or primary sclerosing cholangitis yielded a PPV of 89.7% (95% CI: 82.8-94.6%). Further exclusion of patients with recent immune checkpoint inhibitor therapy increased the PPV to 92.9% (95% CI: 86.5-96.9%). Conclusions The use of ICD codes for AIH alone are insufficient to reliably identify patients with AIH in health administrative data and claims. Our proposed algorithm that includes additional diagnostic and medication-related coding criteria demonstrates excellent performance.

ObjectiveOur aim was to explore the risk of infection with all classes of inflammatory bowel disease (IBD) medications and the impact of these medications on the disease course in a nationwide cohort of patients with IBD.DesignThis was a retrospective national cohort study of patients with IBD in the Veterans Affairs Healthcare System. We categorised IBD medication use immediately prior to the COVID-19 pandemic and used survival analysis methods to study associations with SARS-CoV-2 infection, as well as a combined secondary outcome of COVID-19 hospitalisation or COVID-19-related mortality.ResultsThe analytical cohort of 30 911 patients was primarily male (90.9%), white (78.6%) and with ulcerative colitis (58.8%). Over a median follow-up of 10.7 months, 649 patients (2.1%) were diagnosed with SARS-CoV-2 infection and 149 (0.5%) met the combined secondary outcome. In adjusted models, vedolizumab (VDZ) use was significantly associated with infection relative to mesalazine alone (HR 1.70, 95% CI 1.16 to 2.48, p=0.006). Patients on no IBD medications had increased risk of the combined secondary outcome relative to mesalazine alone (sub-HR 1.64, 95% CI 1.12 to 2.42, p=0.01), however, no other IBD medication categories were significantly associated with this outcome, relative to mesalazine alone (each p>0.05). Corticosteroid use was independently associated with both SARS-CoV-2 infection (HR 1.60, 95% CI 1.23 to 2.09, p=0.001) and the combined secondary outcome (sub-HR 1.90, 95% CI 1.14 to 3.17, p=0.01).ConclusionVDZ and corticosteroid were associated with an increased risk of SARS-CoV-2 infection. Except for corticosteroids no medications including mesalazine were associated with an increased risk of severe COVID-19.

Background and aims Patients with cirrhosis are at increased risk of postoperative mortality. Currently available tools to predict postoperative risk are suboptimally calibrated and do not account for surgery type. Our objective was to use population-level data to derive and internally validate cirrhosis surgical risk models. Approach and results We conducted a retrospective cohort study using data from the Veterans Outcomes and Costs Associated with Liver Disease (VOCAL) cohort, which contains granular data on patients with cirrhosis from 128 U.S. medical centers, merged with the Veterans Affairs Surgical Quality Improvement Program (VASQIP) to identify surgical procedures. We categorized surgeries as abdominal wall, vascular, abdominal, cardiac, chest, or orthopedic and used multivariable logistic regression to model 30-, 90-, and 180-day postoperative mortality (VOCAL-Penn models). We compared model discrimination and calibration of VOCAL-Penn to the Mayo Risk Score (MRS), Model for End-Stage Liver Disease (MELD), Model for End-Stage Liver Disease-Sodium MELD-Na, and Child-Turcotte-Pugh (CTP) scores. We identified 4,712 surgical procedures in 3,785 patients with cirrhosis. The VOCAL-Penn models were derived and internally validated with excellent discrimination (30-day postoperative mortality C-statistic = 0.859; 95% confidence interval [CI], 0.809-0.909). Predictors included age, preoperative albumin, platelet count, bilirubin, surgery category, emergency indication, fatty liver disease, American Society of Anesthesiologists classification, and obesity. Model performance was superior to MELD, MELD-Na, CTP, and MRS at all time points (e.g., 30-day postoperative mortality C-statistic for MRS = 0.766; 95% CI, 0.676-0.855) in terms of discrimination and calibration. Conclusions The VOCAL-Penn models substantially improve postoperative mortality predictions in patients with cirrhosis. These models may be applied in practice to improve preoperative risk stratification and optimize patient selection for surgical procedures (www.vocalpennscore.com).

Data on the epidemiology of autoimmune hepatitis (AIH) in the United States are limited. This study investigated the sociodemographic and geographic factors associated with AIH incidence and prevalence with and without cirrhosis.In a retrospective cohort of adults in the Optum Clinformatics Data Mart (2009-2018), we identified AIH cases using a validated claims-based algorithm. Incidence and prevalence were compared between sociodemographic subgroups. Logistic regression evaluated the association of US Census Division with AIH incidence and the factors associated with incident AIH with cirrhosis. From 2009 to 2018, the age- and sex-standardized prevalence of AIH in the Optum cohort was 26.6 per 100,000 persons with an incidence of 4.0 per 100,000 person-years. AIH incidence increased earlier among Hispanics (age 50-59 years) and later among Asians (≥80 years). Adjusted AIH incidence was higher in the Mountain Division (odds ratio [OR] 1.17) and lower in the Pacific (OR 0.68), Middle Atlantic (OR 0.81), and West North Central Divisions (OR 0.86 vs. East North Central; p 0.001). Male sex (OR 1.31, p = 0.003), Black race (OR 1.32, p = 0.022), and Hispanic ethnicity (OR 1.37 vs. non-Hispanic White, p = 0.009) were associated with incident AIH with cirrhosis. Incident AIH with cirrhosis was greater in the West South Central Division (OR 1.30 vs. South Atlantic; p = 0.008).AIH epidemiology differs according to sociodemographic and geographic factors in the United States. Studies are needed to determine the genetic, epigenetic, and environmental factors underlying the heterogeneity in AIH risk and outcomes.

Background Patients with inflammatory bowel disease (IBD) may be at risk for development of COVID-19 infection due to innate immune dysfunction and/or immunosuppressive medication use. Methods In a prospective cohort of adult IBD patients, we captured data on clinical risk factors and IBD medication utilization. The outcome of interest was development of patient-reported laboratory confirmed COVID-19. We calculated incidence rate and performed bivariate analyses to describe the effects of risk factors (age, immunosuppression use, obesity, and race) on development of COVID-19. We utilized logistic regression models to determine the independent risks associated with each factor. Results A total of 3953 patients with IBD were followed for a mean duration of 212 days (SD 157). A total of 103 individuals developed COVID-19 during follow-up (2.6%, rate of 45 per 1000 person-years). Severity of infection was generally mild. Clinical characteristics were similar among those who developed COVID-19 as compared to not. African American race was associated with incident COVID-19 infection (OR 3.37, 95% CI 1.18–9.59). Immunosuppression use was not associated with development of COVID-19 (OR 1.19, 95% CI 0.72–1.75), nor was age (OR 1.00, 95% CI 0.99–1.02), nor obesity (OR 1.01, 95% CI 0.61–1.66). Conclusions Immunosuppression use did not increase the risk of development of COVID-19. Therapeutic management of IBD should not be altered to prevent a risk of developing COVID-19.

Introduction Opioid use in patients with inflammatory bowel disease (IBD) is associated with increased mortality. Previous interventions targeting reduced intravenous opioid (IVOPI) exposure for all patients admitted to a general medical unit have decreased total opioid use without compromising pain control. We therefore performed a prospective evaluation of a multimodal intervention encouraging the use of nonopioid alternatives to reduce IVOPI exposure among patients with IBD hospitalized at our institution. Methods This was a prospective evaluation of a multimodal intervention to reduce IVOPI use among patients with IBD aged ≥18 years admitted to a general medical unit at a large urban academic medical center from January 1, 2019, to June 30, 2019. Intravenous and total (all routes) opioid exposures were measured as proportions and intravenous morphine milligram equivalents/patient day and compared with preintervention (January 1, 2018, to December 31, 2018) data. Hospital length of stay (LOS), 30-day readmission rates (RRs), and pain scores (1-10 scale) were also assessed. Results Our study involved 345 patients with IBD with similar baseline characteristics in preintervention (n = 241) and intervention (n = 104) periods. Between study periods, we observed a significant reduction in the proportion of patients receiving IVOPIs (43.6% vs 30.8%, P = 0.03) and total opioid dose exposure (15.6 vs 8.5 intravenous morphine mg equivalents/d, P = 0.02). We observed similar mean pain scores (3.9 vs 3.7, P = 0.55) and significantly reduced mean LOS (7.2 vs 5.3 days, P = 0.03) and 30-day RRs (21.6% vs 11.5%, P = 0.03). Discussion A multimodal intervention was associated with reduced opioid exposure, LOS, and 30-day RRs for hospitalized patients with IBD. Additional research is needed to determine long-term benefits of reduced opioid exposure in this population.

Introduction There are limited data on repeated basal cell cancer (BCC) occurrences among patients with inflammatory bowel disease (IBD), especially the impact of continuing immunosuppressive medications. Methods We conducted a retrospective cohort study of 54,919 patients with IBD followed in the Veterans Affairs Healthcare System. We identified patients who had an incident BCC after their IBD diagnosis. We defined patients' exposure based on their IBD medications use as follows: (i) only aminosalicylate (5-ASA) use, (ii) only active thiopurine (TP) use, (iii) past TP use (discontinued >6 months ago) and no antitumor necrosis factor (TNF) use, (iv) anti-TNF use after previous TP use, (v) only anti-TNF use, and (vi) active anti-TNF and TP use. The outcome of interest was the repeated occurrence of BCC. Adjusted and unadjusted hazard ratios with 95% confidence intervals were used to estimate the risk of repeated BCC occurrence. Results A total of 518 patients developed BCC after their IBD diagnosis. The numbers of repeated BCC occurrences per 100 person-years were 12.8 (5-ASA use only), 34.5 (active TP use), 19.3 (past TP use and no anti-TNF use), 25.4 (anti-TNF use after previous TP use), 17.8 (only anti-TNF use), and 22.4 (active anti-TNF and TP use). Compared with 5-ASA use alone, only active TP use was associated with an increased risk for repeated BCC occurrence (adjusted hazard ratio 1.65, 95% confidence interval 1.24-2.19; P = 0.0005). However, the increased risk was no longer present for other exposure categories. Discussion Among IBD patients who developed an incident BCC while taking a TP and continued it, there was an increased risk of repeated BCC occurrences.

Vacant spaces, such as unplanted, unmanaged, or infrequently accessed green roofs, may play a critical role in sustaining biodiversity in cities. Initial plant composition of these spaces likely is contingent on seed dispersal and growing medium, yet no studies have directly characterized the effects of location or growing medium depth on plant diversity of unplanted green roofs. To address this gap, we studied first-year community composition of five unplanted green roofs in New York City (NY, USA). On each roof, 12 plots were established with media depths ranging from 5 to 13 cm. Four months after installation, all plants were harvested. We observed 29 species across locations; five species were found on all five roofs, while 13 species each were observed on a single roof. Introduced species accounted for 14 of the 29 species found across roofs. Species richness and composition differed among roofs, while functional richness varied within, but not among, roofs. About 80% of the variation in species richness was accounted for by total green space in the neighborhoods within 100 to 200 m of each roof. Functional richness and plant cover increased with increased growing medium depth, as did the relative abundance of annual and forb species. Our results suggest both location and growing medium depth will affect initial community composition of unmanaged green roofs, but with differential effects on community assembly. These results also highlight the potential role of unmanaged vacant roofs as reservoirs of plant diversity, both native and invasive, in urban spaces.