Association between proactive esophageal cooling and increased lab throughput.

INTRODUCTION: Proactive esophageal cooling has been FDA cleared to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency (RF) cardiac ablation procedures. Data suggest that procedure times for RF pulmonary vein isolation (PVI) also decrease when proactive esophageal cooling is employed instead of luminal esophageal temperature (LET) monitoring. Reduced procedure times may allow increased electrophysiology (EP) lab throughput. We aimed to quantify the change in EP lab throughput of PVI cases after the introduction of proactive esophageal cooling. METHODS: EP lab throughput data were obtained from three EP groups. We then compared EP lab throughput over equal time frames at each site before (pre-adoption) and after (post-adoption) the adoption of proactive esophageal cooling. RESULTS: Over the time frame of the study, a total of 2498 PVIs were performed over a combined 74 months, with cooling adopted in September 2021, November 2021, and March 2022 at each respective site. In the pre-adoption time frame, 1026 PVIs were performed using a combination of LET monitoring with the addition of esophageal deviation when deemed necessary by the operator. In the post-adoption time frame, 1472 PVIs were performed using exclusively proactive esophageal cooling, representing a mean 43% increase in throughput (p < .0001), despite the loss of two operators during the post-adoption time frame. CONCLUSION: Adoption of proactive esophageal cooling during PVI ablation procedures is associated with a significant increase in EP lab throughput, even after a reduction in total number of operating physicians in the post-adoption group.

Atrioesophageal Fistula Rates Before and After Adoption of Active Esophageal Cooling During Atrial Fibrillation Ablation.

BACKGROUND: Active esophageal cooling reduces the incidence of endoscopically identified severe esophageal lesions during radiofrequency (RF) catheter ablation of the left atrium for the treatment of atrial fibrillation. A formal analysis of the atrioesophageal fistula (AEF) rate with active esophageal cooling has not previously been performed. OBJECTIVES: The authors aimed to compare AEF rates before and after the adoption of active esophageal cooling. METHODS: This institutional review board (IRB)-approved study was a prospective analysis of retrospective data, designed before collecting and analyzing the real-world data. The number of AEFs occurring in equivalent time frames before and after adoption of cooling using a dedicated esophageal cooling device (ensoETM, Attune Medical) were quantified across 25 prespecified hospital systems. AEF rates were then compared using generalized estimating equations robust to cluster correlation. RESULTS: A total of 14,224 patients received active esophageal cooling during RF ablation across the 25 hospital systems, which included a total of 30 separate hospitals. In the time frames before adoption of active cooling, a total of 10,962 patients received primarily luminal esophageal temperature (LET) monitoring during their RF ablations. In the preadoption cohort, a total of 16 AEFs occurred, for an AEF rate of 0.146%, in line with other published estimates for procedures using LET monitoring. In the postadoption cohort, no AEFs were found in the prespecified sites, yielding an AEF rate of 0% (P < 0.0001). CONCLUSIONS: Adoption of active esophageal cooling during RF ablation of the left atrium for the treatment of atrial fibrillation was associated with a significant reduction in AEF rate.

Improved 1-year outcomes after active cooling during left atrial radiofrequency ablation.

BACKGROUND: Active esophageal cooling during pulmonary vein isolation (PVI) with radiofrequency (RF) ablation for the treatment of atrial fibrillation (AF) is increasingly being utilized to reduce esophageal injury and atrioesophageal fistula formation. Randomized controlled data also show trends towards increased freedom from AF when using active cooling. This study aimed to compare 1-year arrhythmia recurrence rates between patients treated with luminal esophageal temperature (LET) monitoring versus active esophageal cooling during left atrial ablation. METHOD: Data from two healthcare systems (including 3 hospitals and 4 electrophysiologists) were reviewed for patient rhythm status at 1-year follow-up after receiving PVI for the treatment of AF. Results were compared between patients receiving active esophageal cooling (ensoETM, Attune Medical, Chicago, IL) and those treated with traditional LET monitoring using Kaplan-Meier estimates. RESULTS: A total of 513 patients were reviewed; 253 received LET monitoring using either single or multi-sensor temperature probes; and 260 received active cooling. The mean age was 66.8 (SD ± 10) years, and 36.8% were female. Arrhythmias were 60.1% paroxysmal AF, 34.3% persistent AF, and 5.6% long-standing persistent AF, with no significant difference between groups. At 1-year follow-up, KM estimates for freedom from AF were 58.2% for LET-monitored patients and 72.2% for actively cooled patients, for an absolute increase in freedom from AF of 14% with active esophageal cooling (p = .03). Adjustment for the confounders of patient age, gender, type of AF, and operator with an inverse probability of treatment weighted Cox proportional hazards model yielded a hazard ratio of 0.6 for the effect of cooling on AF recurrence (p = 0.045). CONCLUSIONS: In this first study to date of the association between esophageal protection strategy and long-term efficacy of left atrial RF ablation, a clinically and statistically significant improvement in freedom from atrial arrhythmia at 1 year was found in patients treated with active esophageal cooling when compared to patients who received LET monitoring. More rigorous prospective studies or randomized studies are required to validate the findings of the current study.

Death or survival, which you measure may affect conclusions: A methodological study.

Background and Aims: Considering the opposite outcome-for example, survival instead of death-may affect conclusions about which subpopulation benefits more from a treatment or suffers more from an exposure. Methods: For case studies on death following COVID-19 and bankruptcy following melanoma, we compute and interpret the relative risk, odds ratio, and risk difference for different age groups. Since there is no established effect measure or outcome for either study, we redo these analyses for survival and solvency. Results: In a case study on COVID-19 that ignores confounding, the relative risk of death suggested that 40-49-year-old Mexicans with COVID-19 suffered more from their unprepared healthcare system, using Italy's system as a baseline, than their 60-69-year-old counterparts. The relative risk of survival and the risk difference suggested the opposite conclusion. A similar phenomenon occurred in a case study on bankruptcy following melanoma treatment. Conclusion: To increase transparency around this paradox, researchers reporting one outcome should note if considering the opposite outcome would yield different conclusions. When possible, researchers should also report or estimate underlying risks alongside effect measures.

Assessing risk factors for latent and active tuberculosis among persons living with HIV in Florida: A comparison of self-reports and medical records.

PURPOSE: This study examined factors associated with TB among persons living with HIV (PLWH) in Florida and the agreement between self-reported and medically documented history of tuberculosis (TB) in assessing the risk factors. METHODS: Self-reported and medically documented data of 655 PLWH in Florida were analyzed. Data on sociodemographic factors such as age, race/ethnicity, place of birth, current marital status, education, employment, homelessness in the past year and 'ever been jailed' and behavioural factors such as excessive alcohol use, marijuana, injection drug use (IDU), substance and current cigarette use were obtained. Health status information such as health insurance status, adherence to HIV antiretroviral therapy (ART), most recent CD4 count, HIV viral load and comorbid conditions were also obtained. The associations between these selected factors with self-reported TB and medically documented TB diagnosis were compared using Chi-square and logistic regression analyses. Additionally, the agreement between self-reports and medical records was assessed. RESULTS: TB prevalence according to self-reports and medical records was 16.6% and 7.5% respectively. Being age ≥55 years, African American and homeless in the past 12 months were statistically significantly associated with self-reported TB, while being African American homeless in the past 12 months and not on antiretroviral therapy (ART) were statistically significantly associated with medically documented TB. African Americans compared to Whites had odds ratios of 3.04 and 4.89 for self-reported and medically documented TB, respectively. There was moderate agreement between self-reported and medically documented TB (Kappa = 0.41). CONCLUSIONS: TB prevalence was higher based on self-reports than medical records. There was moderate agreement between the two data sources, showing the importance of self-reports. Establishing the true prevalence of TB and associated risk factors in PLWH for developing policies may therefore require the use of self-reports and confirmation by screening tests, clinical signs and/or microbiologic data.

Comparative Safety of Sleeve Gastrectomy and Roux-en-Y: A Propensity Score Analysis.

BACKGROUND: Use of bariatric surgery has increased dramatically in the USA. However, there are growing concerns regarding the safety outcomes of different bariatric procedures. We aim to compare the safety of sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB), which includes hospital readmissions, emergency room (ER) visits, gastrointestinal bleeding, and revisional surgery. METHODS: A retrospective cohort analysis was conducted for adults (≥ 18 years) who received SG and RYGB in the USA. We used Truven MarketScan Commercial and Medicare supplemental claims databases from January 1, 2005, to October 1, 2015. To adjust for baseline demographic and clinical characteristics, we used stabilized inverse probability of treatment weighting using propensity score. Cox proportional hazard models was used to compare safety outcomes between SG and RYGB after bariatric surgery. RESULTS: A total of 194,248 patients met inclusion criteria; 79,813 patients (41%) received SG and 114,435 patients (59%) received RYGB. The use of SG was associated with a significantly lower 30-day hospital readmission rate [adjusted hazard ratios (aHRs) 0.77; 95% confidence interval (CI), 0.74-0.81] and ER visits [aHR, 0.82; 95% CI, 0.80-0.83], and decreased risk of gastrointestinal bleeding [aHR, 0.87; 95% CI, 0.78-0.98] compared to RYGB. However, SG was associated with an increased risk of revisional surgery, compared to RYGB [aHR,1.21; 95% CI, 1.08-1.35]. CONCLUSIONS: Among patients receiving bariatric surgery in a real-world setting, SG was associated with lower complication rate but a higher risk of revisional surgery compared to RYGB. Further longitudinal studies are needed to assess long-term findings.

Older Adults Demonstrate Biomarker Evidence of the Persistent Inflammation, Immunosuppression, and Catabolism Syndrome (PICS) After Sepsis.

BACKGROUND: Hospital deaths after sepsis have decreased substantially and most young adult survivors rapidly recover (RAP). However, many older survivors develop chronic critical illness (CCI) with poor long-term outcomes. The etiology of CCI is multifactorial and the relative importance remains unclear. Sepsis is caused by a dysregulated immune response and biomarkers reflecting a persistent inflammation, immunosuppression, and catabolism syndrome (PICS) have been observed in CCI after sepsis. Therefore, the purpose of this study was to compare serial PICS biomarkers in (i) older (vs young) adults and (ii) older CCI (vs older RAP) patients to gain insight into underlying pathobiology of CCI in older adults. METHOD: Prospective longitudinal study with young (≤45 years) and older (≥65 years) septic adults, who were characterized by (i) baseline predisposition, (ii) hospital outcomes, (iii) serial Sequential Organ Failure Assessment (SOFA) organ dysfunction scores over 14 days, (iv) Zubrod Performance status at 3-, 6-, and 12-month follow-up, and (v) mortality over 12 months, was conducted. Serial blood samples over 14 days were analyzed for selected biomarkers reflecting PICS. RESULTS: Compared to the young, more older adults developed CCI (20% vs 42%) and had markedly worse serial SOFA scores, performance status, and mortality over 12 months. Additionally, older (vs young) and older CCI (vs older RAP) patients had more persistent aberrations in biomarkers reflecting inflammation, immunosuppression, stress metabolism, lack of anabolism, and antiangiogenesis over 14 days after sepsis. CONCLUSION: Older (vs young) and older CCI (vs older RAP) patient subgroups demonstrate early biomarker evidence of the underlying pathobiology of PICS.

Prevalence of HIV-related stigma in adults living with HIV & disability in Florida, 2015-2016.

Using data collected from the Florida Medical Monitoring Project, we sought to compare the prevalence of overall HIV-related stigma, including its subdimensions among persons with HIV and disability(s) and persons with HIV without disability in Florida. Disability was classified as having difficulty in one or more areas: activity limitations, participation restrictions, and functional or sensory activities. HIV-related stigma was assessed using the HIV Stigma Scale, which measures (1) overall stigma (2) negative self-image, (3) personalized, and (4) anticipated stigma. Multivariate analysis indicates that the crude prevalence ratios of overall stigma, including negative self-image, personalized, and anticipated stigma among persons with HIV and disability(s) were 1.43, 1.24, 1.20, and 1.23 compared to persons with HIV without disability, respectively. After adjusting for confounders, the prevalence ratios of HIV-related stigma ranged from 1.33-1.07 among persons with HIV and disability(s) compared to persons with HIV without disability. The implications of these findings reveal that persons with HIV and disability(s) are more vulnerable to HIV-related stigma. Researchers could consider distinct stigma interventions tailored towards persons with HIV and disability(s) in Florida.

Clinical Trajectories of Acute Kidney Injury in Surgical Sepsis: A Prospective Observational Study.

OBJECTIVE: To characterize endothelial function, inflammation, and immunosuppression in surgical patients with distinct clinical trajectories of AKI and to determine the impact of persistent kidney injury and renal non-recovery on clinical outcomes, resource utilization, and long-term disability and survival. SUMMARY OF BACKGROUND DATA: AKI is associated with increased healthcare costs and mortality. Trajectories that account for duration and recovery of AKI have not been described for sepsis patients, who are uniquely vulnerable to renal dysfunction. METHODS: This prospective observational study included 239 sepsis patients admitted and enrolled between January 2015 and July 2017. Kidney Disease: Improving Global Outcomes (KDIGO) and Acute Disease Quality Initiative (ADQI) criteria were used to classify subjects as having no AKI, rapidly reversed AKI, persistent AKI with renal recovery, or persistent AKI without renal recovery. Serial biomarker profiles, clinical outcomes, resource utilization, and long-term physical performance status and survival were compared among AKI trajectories. RESULTS: Sixty-two percent of the study population developed AKI. Only one-third of AKI episodes rapidly reversed within 48 hours; the remaining had persistent AKI, among which 57% did not have renal recovery by discharge. One-year survival and proportion of subjects fully active 1 year after sepsis was lowest among patients with persistent AKI compared with other groups. Long-term mortality hazard rates were 5-fold higher for persistent AKI without renal recovery compared with no AKI. CONCLUSIONS: Among critically ill surgical sepsis patients, persistent AKI and the absence of renal recovery are associated with distinct early and sustained immunologic and endothelial biomarker signatures and decreased long-term physical function and survival.

Estimated vs measured energy expenditure in ventilated surgical-trauma critically ill patients.

BACKGROUND: The American and European guidelines recommend measuring resting energy expenditure (REE) using indirect calorimetry (IC). Predictive equations (PEs) are used to estimate REE, but there is limited evidence for their use in critically ill patients. The aim of this study is to evaluate the degree of agreement and accuracy between IC-measured REE (REE-IC) and 10 different PEs in mechanically ventilated critically ill patients with surgical trauma who met their estimated energy requirement. METHODS: REE-IC was retrospectively compared with REE-PE by 10 PEs. The degree of agreement between REE-PE and REE-IC was analyzed by the Bland-Altman test (BAt) and the concordance correlation coefficient (CCC). The accuracy was calculated by the percentage of patients whose REE-PE values differ by up to ±10% in relation to REE-IC. All analyses were stratified by gender and body mass index (BMI; <25 vs ≥25). RESULTS: We analyzed 104 patients and the closest estimate to REE-IC was the modified Harris-Benedict equation (mHB) by the BAt with a mean difference of 49.2 overall (61.6 for males, 28.5 for females, 67.5 for BMI <25, and 42.5 for BMI ≥25). The overall CCC between the REE-IC and mHB was 0.652 (0.560 for males, 0.496 for females, 0.570 for BMI <25, and 0.598 for BMI ≥25). The mHB equation was the most accurate with an overall accuracy of 44.2%. CONCLUSION: The effectiveness of PEs for estimating the REE of mechanically ventilated surgical-trauma critically ill patients is limited. [Correction added on 17 February 2022, after first online publication: The word "with" was deleted before "is limited" in the preceding sentence.] Nonetheless, of the 10 equations examined, the closest to REE-IC was the mHB equation.

Association of persistent acute kidney injury and renal recovery with mortality in hospitalised patients.

OBJECTIVES: Acute kidney injury (AKI) affects up to one-quarter of hospitalised patients and 60% of patients in the intensive care unit (ICU). We aim to understand the baseline characteristics of patients who will develop distinct AKI trajectories, determine the impact of persistent AKI and renal non-recovery on clinical outcomes, resource use, and assess the relative importance of AKI severity, duration and recovery on survival. METHODS: In this retrospective, longitudinal cohort study, 156 699 patients admitted to a quaternary care hospital between January 2012 and August 2019 were staged and classified (no AKI, rapidly reversed AKI, persistent AKI with and without renal recovery). Clinical outcomes, resource use and short-term and long-term survival adjusting for AKI severity were compared among AKI trajectories in all cohort and subcohorts with and without ICU admission. RESULTS: Fifty-eight per cent (31 500/54 212) had AKI that rapidly reversed within 48 hours; among patients with persistent AKI, two-thirds (14 122/22 712) did not have renal recovery by discharge. One-year mortality was significantly higher among patients with persistent AKI (35%, 7856/22 712) than patients with rapidly reversed AKI (15%, 4714/31 500) and no AKI (7%, 22 117/301 466). Persistent AKI without renal recovery was associated with approximately fivefold increased hazard rates compared with no AKI in all cohort and ICU and non-ICU subcohorts, independent of AKI severity. DISCUSSION: Among hospitalised, ICU and non-ICU patients, persistent AKI and the absence of renal recovery are associated with reduced long-term survival, independent of AKI severity. CONCLUSIONS: It is essential to identify patients at risk of developing persistent AKI and no renal recovery to guide treatment-related decisions.

Fidelity of a Traffic Safety Education Intervention for Combat Veterans.

Equipoise, feasibility, and fidelity were studied for the control condition of an occupational therapy driving intervention in a randomized controlled trial. We ranked equipoise and feasibility of six traffic safety education methods and created an implementation fidelity competency checklist. Education method selection was informed using the proportion of concordant ranks analysis while literature and a peer review informed competency checklist development. A proctored-online course delivery had the highest rater agreement (equipoise = .96 [.87-1.00]; feasibility = .99 [.97-1.00]). Implementation fidelity was supported by a 19-component training and evaluation checklist. This study supports promoting the scientific rigor of the RCT via - equipoise, feasibility, and implementation fidelity.

Use of negative controls in a prescription sequence symmetry analysis to reduce time-varying bias.

PURPOSE: There is an increased use in the (prescription) sequence symmetry analysis (PSSA); however, limited studies have incorporated a negative control, and no study has formally quantified and controlled for within-patient time-varying bias using a negative control. Our aim was to develop a process to incorporate the effect of negative controls into the main analysis of a PSSA. METHODS: Using a previously assessed dihydropyridine calcium channel blocker (DH-CCB) and loop diuretic PSSA, we directly compared the adjusted sequence ratios (aSRs) of DH-CCBs to each of the two negative control index drugs (levothyroxine and angiotensin converting enzyme [ACE] inhibitor/angiotensin-2 receptor blocker [ARB]) using the ratio of the aSRs to estimate a relative aSR with a Z test. Further, we utilized the relative aSR in stratum-specific analyses and varying exposure windows. RESULTS: The relative aSR of DH-CCBs decreased from 1.87 to 1.72 (95% CI 1.66-1.78) using levothyroxine as a negative control index drug. ACE inhibitor/ARB negative control index drug resulted in an aSR of 1.27 thus reducing the relative aSR for DH-CBB from 1.84 to 1.45 (95% CI 1.41-1.49). When restricting the exposure window to 180 and 90 days, the relative aSR of DH-CCBs increased to 1.68 (95% CI 1.62-1.74) and 1.86 (95% CI 1.78-1.94), respectively, relative to the ACE inhibitor/ARB negative control index drug. CONCLUSION: We illustrated how to incorporate negative control index drugs into a PSSA and generate relative aSRs. Stratum-specific assessments and varying the exposure windows while using negative control index drugs can yield more informative results.

Quality of opioid prescribing in older adults with or without Alzheimer disease and related dementia.

BACKGROUND: Pain is common among individuals with Alzheimer's disease and related dementias (ADRD), and use of opioids has been increasing over the last decade. Yet, it is unclear to what extent opioids are appropriately prescribed for patients with ADRD and whether the appropriateness of opioid prescribing differs by ADRD status. The objective of this study is to compare the quality of opioid prescribing among patients with or without ADRD who have chronic noncancer pain. METHODS: A nationally representative cohort study of Medicare beneficiaries aged 50 years or older who had chronic pain but who had no cancer, hospice, or palliative care from 2011 to 2015. Four indicators of potentially inappropriate opioid prescribing were measured in patients residing in communities (75,258 patients with and 435,870 patients without ADRD); five indicators were assessed in patients in nursing homes (NHs) (37,117 patients with and 5128 patients without ADRD). Each indicator was calculated as the proportion of eligible patients with inappropriate opioid prescribing in the year after a chronic pain diagnosis. Differences in proportions between ADRD and non-ADRD groups were estimated using a generalized linear model adjusting for covariates through inverse probability weighting. RESULTS: Patients with ADRD versus those without had higher concurrent use of opioids and central nervous system-active drugs (community 44.1% vs 33.3%; NH 58.8% vs 54.1%, both P < 0.001) and no opioids or scheduled pain medications for moderate or severe pain (NH 60.1% vs 52.5%, P < 0.001). The ADRD versus non-ADRD group had higher use of long-term opioids for treating neuropathic pain in communities (21.7% vs 19.5%, P = 0.003) but lower use in NHs (26.9% vs 36.0%, P < 0.001). Use of strong or high-dose opioids when naive to opioids (community 1.5% vs 2.8%; NH 2.5% vs 3.5%) and use of contraindicated opioids (community 0.08% vs 0.12%; NH 0.05% vs 0.21%) were rare for either group. CONCLUSION: Potential inappropriate opioid prescribing in 2 areas of pain care was more common among patients with ADRD than among patients without ADRD in community or NH settings. Further studies aimed at understanding the factors and effects associated with opioid prescribing patterns that deviate from guidelines are warranted.

Negative Consequences of Alcohol Use among People Living with HIV.

Introduction: Among people living with HIV (PLWH), alcohol use can have negative impacts beyond HIV-related outcomes. The objectives of this study are to identify the most common alcohol-related consequences among PLWH in Florida and describe factors associated with experiencing more alcohol-related consequences. Methods: Data were collected from PLWH in the Florida Cohort study who drank at least monthly in the past year (n=397). Self-reported consequences were assessed by the 15-item Short Inventory of Problems Revised (SIP-2R). Nonparametric tests and a generalized estimating equation model with inverse probability of exposure weighting were used to evaluate associations between the total SIP-2R score and socio-demographics, mental health, and substance use while controlling for alcohol use. Results: Over half (56%) endorsed at least one consequence and 29% endorsed 5 or more consequences. The most common consequences were doing something they regretted and taking foolish risks (both endorsed by 37% of participants), both in the impulse control domain. After controlling for alcohol use and other covariates, homelessness and injection drug use remained significantly associated with greater SIP-2R scores. Conclusion: PLWH who are experiencing homelessness or injecting drugs could benefit from receiving additional screening for alcohol-related consequences if they report any alcohol use.

Impact of Reduction in Drinking vs. complete Cessation on the Severity and Type of Alcohol-Related Problems in Women Living with HIV.

BACKGROUND: Women living with HIV (WLWH) often report heavy alcohol use and may experience substantial alcohol-related problems, but it is unclear whether it is necessary to completely quit drinking to reduce such problems. OBJECTIVES: To assess whether complete reduction of alcohol use produced significantly greater improvement in alcohol-related problems than a partial reduction of alcohol use (reducing alcohol use to ≤7 or ≤14 drinks per week). METHODS: We used data from a randomized clinical trial examining the effectiveness of Naltrexone in WLWH who reported heavy drinking (>7 drinks/week) at baseline. The primary outcome (alcohol-related problems) was measured using the Short Inventory of Problems. The primary predictor (drinking status: quit drinking, reduced drinking, continue heavy drinking) was measured using a 30-day timeline followback. RESULTS: The sample consisted of 163 WLWH (50% 50 years or older, 85% Black). WLWH who reported past violence had significantly greater mean SIP scores at baseline (19.9 vs. 10.5, p<.0001). Forty-eight percent of women quit drinking by 7 months and 28% reduced drinking to ≤7 drinks/week; these women had significant reduction in alcohol-related problems compared to those who continued heavy drinking (-8.2 and -4.8 vs. -0.8, p = 0.0003). Quitting and reducing drinking were also associated with statistically significant decreases among the physical, interpersonal, intrapersonal, and social subscales of the SIP (p<.05), although a similar pattern, while not statistically significant, exists for the impulse control subscale. CONCLUSIONS: While completely quitting drinking produced the greatest improvement, reducing drinking to ≤14 drinks per week can significantly reduce alcohol-related problems in WLWH.

US national trends in bariatric surgery: A decade of study.

BACKGROUND: Since the 1990s, the number of bariatric surgeries has dramatically increased, including the number of bariatric centers in the United States; no recent studies have yet assessed trends of bariatric surgery. This study aims to assess the trends of bariatric surgery and the change in utilization by the type of surgery, from 2006 to 2015, using real-world data. METHODS: A cross-sectional analysis of MarketScan databases of privately insured beneficiaries aged equal to or more than 18 years, to assess the annual incidence rate of bariatric surgery type of surgery from 2006 to 2015. Linear regression analysis was used to assess the significance of bariatric surgery changes over time. RESULTS: A gradual increase in overall bariatric surgery was observed from 43.5 per 100,000 in 2006 to 70.6 per 100,000 in 2009. This increasing trend plateaued from 2010 to 2015. Among all bariatric surgeries performed, the sleeve gastrectomy showed a significant increase from (n = 596) 11% in 2006 to (n = 15,425) 70% in 2015 (P < .001), whereas there was a decrease in Roux-en-Y from (n = 10,129) 45% in 2010 to (n = 5074) 24% in 2015 (P < .001). CONCLUSION: Utilization of bariatric surgery showed a gradual increase in the first 5 years, with steady rates in the last 5 years of the study period. Sleeve gastrectomy and Roux-en-Y remain the most performed bariatric procedures. Laparoscopic surgery continues to dominate bariatric surgery compared with open surgery.

Non-steroidal anti-inflammatory drug-associated acute kidney injury: does short-term NSAID use pose a risk in hospitalized patients?

PURPOSE: While renal risk associated with short-term use of non-steroidal anti-inflammatory drugs (NSAID) has been anecdotally documented, no conclusive evidence is available on the renal safety, especially among hospitalized patients with reduced renal function. This study is to evaluate the risk of acute kidney injury (AKI) associated with NSAID use in hospital. METHODS: A retrospective matched cohort study utilizing electronic health records from two large academic tertiary-care hospitals was conducted. We defined AKI based on changes in SCr according to published AKI criteria. The hospital acquired AKI risk associated with inpatient NSAID use was assessed using a time-dependent Cox proportional hazard regression in pooled cohort as well as two sub cohorts stratified by baseline renal function. RESULTS: A total of 18,794 admissions were included in the final cohort. Of 9397 admissions exposed to NSAIDs, 7914 and 1483 admissions were in the "without" and "with baseline renal impairment" cohort, with the same number of matching non-exposed admissions in each of the stratified cohort. The AKI incidences were 6 and 22 events per 1000 patient-days in "without" and "with preexisting renal impairment" cohort, respectively. The adjusted analyses suggested that NSAID use increased AKI risk in patients with preexisting renal impairment (hazard ratio [HR]: 1.38 [1.04-1.83]) but not in the patients without preexisting renal impairment (HR: 0.83 [95% CIs: 0.63-1.08]) or in the pooled cohort (HR: 1.01 [95% CIs: 0.83-1.24]). CONCLUSION: Our findings suggested that NSAID use is associated with an increased risk of AKI in the hospitalized patients with preexisting renal impairment but the association is not statistically significant in those who have preserved renal function. Further randomized controlled trials are needed to validate these observational findings.

An Electronic Tool to Support Patient-Centered Broad Consent: A Multi-Arm Randomized Clinical Trial in Family Medicine.

PURPOSE: Patients are frequently asked to share their personal health information. The objective of this study was to compare the effects on patient experiences of 3 electronic consent (e-consent) versions asking patients to share their health records for research. METHODS: A multi-arm randomized controlled trial was conducted from November 2017 through November 2018. Adult patients (n = 734) were recruited from 4 family medicine clinics in Florida. Using a tablet computer, participants were randomized to (1) a standard e-consent (standard), (2) an e-consent containing standard information plus hyperlinks to additional interactive details (interactive), or (3) an e-consent containing standard information, interactive hyperlinks, and factual messages about data protections and researcher training (trust-enhanced). Satisfaction (1 to 5), subjective understanding (0 to 100), and other outcomes were measured immediately, at 1 week, and at 6 months. RESULTS: A majority of participants (94%) consented to future uses of their health record information for research. No differences in study outcomes between versions were observed at immediate or 1-week follow-up. At 6-month follow-up, compared with the standard e-consent, participants who used the interactive e-consent reported greater satisfaction (B = 0.43; SE = 0.09; P <.001) and subjective understanding (B = 18.04; SE = 2.58; P <.001). At 6-month follow-up, compared with the interactive e-consent, participants who used the trust-enhanced e-consent reported greater satisfaction (B = 0.9; SE = 1.0; P <.001) and subjective understanding (B = 32.2; SE = 2.6, P <.001). CONCLUSIONS: Patients who used e-consents with interactive research details and trust-enhancing messages reported higher satisfaction and understanding at 6-month follow-up. Research institutions should consider developing and further validating e-consents that interactively deliver information beyond that required by federal regulations, including facts that may enhance patient trust in research.

Calibration of Chronic Lung Disease Severity as a Risk Factor for Respiratory Syncytial Virus Hospitalization.

BACKGROUND: Guidelines assume children with chronic lung disease (CLD) who require medical support within 6 months before the second respiratory syncytial virus (RSV) season remains at high risk of severe RSV disease. We determined the number of days since the last treatment (DSL) when the risk of RSV hospitalization among children with CLD becomes equivalent to the risk for those not qualified for immunoprophylaxis. METHODS: The study cohort was assembled using Medicaid billing records from 1999 to 2010 linked to Florida and Texas birth certificate records. We developed DSL-trend discrete time logistic regression models within a survival analysis framework, adjusting for use of immunoprophylaxis, to compare the hospitalization risk of CLD infants at 4 age points to that of term infants at 1 month of age with siblings. RESULTS: The study cohort included 858 830 healthy term and 5562 preterm infants with CLD. Among 1-month-old term infants, the RSV hospitalization risk averaged across all covariate strata was 14.8 (95% confidence interval [CI], 13.5-16.1) per 1000 patient season-months. Risk for preterm CLD children reached the threshold derived from term infants when DSL was 76 (95% CI, 22-198.5), 52 (95% CI, 6.5-123), 35 (95% CI, 0-93.5), and 12 (95% CI, 0-61.5) at the respective ages of 12, 15, 17.2, and 21 months. CONCLUSIONS: The 180-day threshold used to define CLD severity at season start can be shortened to 120 days, 90 days, and 60 days for children with CLD at age 15, 17.2, and 21 months, respectively.