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.

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.

Transcriptomic responses from improved murine sepsis models can better mimic human surgical sepsis.

Historically, murine models of inflammation in biomedical research have been shown to minimally correlate with genomic expression patterns from blood leukocytes in humans. In 2019, our laboratory reported an improved surgical sepsis model of cecal ligation and puncture (CLP) that provides additional daily chronic stress (DCS), as well as adhering to the Minimum Quality Threshold in Pre-Clinical Sepsis Studies (MQTiPSS) guidelines. This model phenotypically recapitulates the persistent inflammation, immunosuppression, and catabolism syndrome observed in adult human surgical sepsis survivors. Whether these phenotypic similarities between septic humans and mice are replicated at the circulating blood leukocyte transcriptome has not been demonstrated. Our analysis, in contrast with previous findings, demonstrated that genome-wide expression in our new murine model more closely approximated human surgical sepsis patients, particularly in the more chronic phases of sepsis. Importantly, our new model of murine surgical sepsis with chronic stress did not reflect well gene expression patterns from humans with community-acquired sepsis. Our work indicates that improved preclinical murine sepsis modeling can better replicate both the phenotypic and transcriptomic responses to surgical sepsis, but cannot be extrapolated to other sepsis etiologies. Importantly, these improved models can be a useful adjunct to human-focused and artificial intelligence-based forms of research in order to improve septic patients' morbidity and mortality.

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.

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.

Impact of an Emergency Department-to-Home Transitional Care Intervention on Health Service Use in Medicare Beneficiaries: A Mixed Methods Study.

BACKGROUND: Hospital-based acute care [emergency department (ED) visits and hospitalizations] that is preventable with high-quality outpatient care contributes to health care system waste and patient harm. OBJECTIVE: To test the hypothesis that an ED-to-home transitional care intervention reduces hospital-based acute care in chronically ill, older ED visitors. RESEARCH DESIGN: Convergent, parallel, mixed-methods design including a randomized controlled trial. SETTING: Two diverse Florida EDs. SUBJECTS: Medicare fee-for-service beneficiaries with chronic illness presenting to the ED. INTERVENTION: The Coleman Care Transition Intervention adapted for ED visitors. MEASURES: The main outcome was hospital-based acute care within 60 days of index ED visit. We also assessed office-based outpatient visits during the same period. RESULTS: The Intervention did not significantly reduce return ED visits or hospitalizations or increase outpatient visits. In those with return ED visits, the Intervention Group was less likely to be hospitalized than the Usual Care Group. Interview themes describe a cycle of hospital-based acute care largely outside patients' control that may be difficult to interrupt with a coaching intervention. CONCLUSIONS AND RELEVANCE: Structural features of the health care system, including lack of access to timely outpatient care, funnel patients into the ED and hospital admission. Reducing hospital-based acute care requires increased focus on the health care system rather than patients' care-seeking decisions.

Secondary Analysis of a Randomized Clinical Trial of Naltrexone Among Women Living With HIV: Correlations Between Reductions in Self-Reported Alcohol Use and Changes in Phosphatidylethanol.

BACKGROUND: Direct biomarkers such as phosphatidylethanol (PEth) have the capability to detect heavy alcohol use, but it is unclear how strongly self-reported reduction in alcohol use correlates with reduction in PEth. We sought to explore the strength of correlation between reductions in self-reported alcohol use and change in PEth among a sample of women living with HIV (WLWH) who participated in a clinical trial to reduce heavy alcohol use. We also sought to determine whether this correlation was stronger in women with lower body mass index (BMI) and women without an alcohol use disorder (AUD). METHODS: 81 WLWH (mean age = 48.7, 80% Black) engaging in a randomized trial of naltrexone versus placebo with a positive baseline PEth (≥8 ng/ml), and alcohol use data at baseline, 2, and 7 months were included in this analysis. Spearman correlation coefficients were compared to measure the correlation between baseline PEth and number of drinks per week by demographic, biological, and alcohol use factors. Mini-International Neuropsychiatric Interview was used to screen for AUD. Further analyses were stratified by BMI and AUD. Spearman correlation coefficients were calculated for the change in PEth and the change in number of drinks per week over 7 months, including 3 time-points: baseline, 2, and 7 months. RESULTS: At baseline, the correlation between baseline PEth and the number of drinks per week was significantly stronger for those with a BMI ≤25 compared to those with a BMI > 25 (r = 0.66; r = 0.26, respectively). Similarly, the correlation between baseline PEth and number of drinks was stronger for those who did not screen positive for AUD compared with those who did (r = 0.66; r = 0.25, respectively). When stratifying by BMI, a low-to-moderate correlation (r = 0.32, p = 0.02) was present for persons with a BMI > 25; when stratifying by AUD, a moderate correlation (r = 0.50, p < 0.01) was present for persons without an AUD between 0 and 2 months only. CONCLUSIONS: In this sample of WLWH, BMI and AUD affected the strength of correlation between PEth and drinks per week. Future work examining changes in PEth over time in broader populations is needed, particularly to understand the sex differences in PEth levels.

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.

The Florida Cohort study: methodology, initial findings and lessons learned from a multisite cohort of people living with HIV in Florida.

In 2013, Florida had the highest rate of new HIV infections and only 56% of persons living with HIV (PLWH) were virally suppressed. In response, we initiated a new HIV cohort in Florida to better understand issues affecting HIV health outcomes. This manuscript will describe the procedures of the Florida Cohort; summarize information regarding enrollment, follow-up, and findings to date; and discuss challenges and lessons learned during the establishment of a multisite cohort of PLWH. Florida Cohort participants were enrolled from eight clinics and community-based organizations geographically diverse counties across Florida. Data were obtained from participant questionnaires, medical records, and state surveillance data. From 2014-2018, 932 PLWH (44% ≥50 years, 64% male, 55% black, 20% Latinx) were enrolled. At baseline, 83% were retained in care and 75% were virally suppressed. Research findings to date have focused on outcomes such as the HIV care continuum, HIV-related comorbidities, alcohol and drug use, and mHealth interventions interest. Strengths included the diversity of the sample and the linkage of participant surveys with existing surveillance data. However, the study had several challenges during planning and follow-up. The lessons learned from this study can be helpful when initiating a new longitudinal cohort study.

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.

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.

HIV-related stigma and life goals among people living with HIV (PLWH) in Florida.

PURPOSE: Goals are an important component of quality of life (QoL) as they provide motivation to accomplish tasks we strive to achieve. Stigma has been identified as a factor that may be deleterious to achieving personal goals. People living with HIV(PLWH) continue to face HIV-related stigma. As HIV prevalence continues to grow in the U.S., it is important to focus on factors that can help improve the health and QoL of PLWH. This study aims to examine the association between HIV-related stigma and goal-setting behaviors among PLWH in Florida. METHODS: We used baseline data collected from the Marijuana and Potential Long-term Effects (MAPLE) observational cohort study. We collected life goals data using an abbreviated version of the Personal Projects Analysis inventory. Participants listed up to three goals in five domains and were asked about each goal's difficulty and importance. HIV-related stigma was measured using an abbreviated version of the Herek HIV-related stigma scale. Relative risk estimates and 95% confidence intervals were estimated using multivariate linear regression models. RESULTS: The overall sample (n = 232) was majority male (52.4%), Black (72.4%), and non-Latino (84.9%). HIV-related stigma was positively associated with the total number of listed goals (ß = 0.042[0.003, 0.082]; p = 0.037) and perceived goal difficulty (ß = 0.010[0.003, 0.017]; p = 0.004), but not significantly associated with perceived goal importance (ß = 0.001[- 0.002, 0.004]; p = 0.562). CONCLUSION: The results suggest that HIV-related stigma may be affecting the pursuit of goals among PLWH. There is a need to develop and evaluate QoL interventions that are tailored to PLWH and focused on achieving goals in the face of HIV-related stigma.

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.

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.

Diaphragm weakness and proteomics (global and redox) modifications in heart failure with reduced ejection fraction in rats.

Inspiratory dysfunction occurs in patients with heart failure with reduced ejection fraction (HFrEF) in a manner that depends on disease severity and by mechanisms that are not fully understood. In the current study, we tested whether HFrEF effects on diaphragm (inspiratory muscle) depend on disease severity and examined putative mechanisms for diaphragm abnormalities via global and redox proteomics. We allocated male rats into Sham, moderate (mHFrEF), or severe HFrEF (sHFrEF) induced by myocardial infarction and examined the diaphragm muscle. Both mHFrEF and sHFrEF caused atrophy in type IIa and IIb/x fibers. Maximal and twitch specific forces (N/cm2) were decreased by 19 ± 10% and 28 ± 13%, respectively, in sHFrEF (p < .05), but not in mHFrEF. Global proteomics revealed upregulation of sarcomeric proteins and downregulation of ribosomal and glucose metabolism proteins in sHFrEF. Redox proteomics showed that sHFrEF increased reversibly oxidized cysteine in cytoskeletal and thin filament proteins and methionine in skeletal muscle α-actin (range 0.5 to 3.3-fold; p < .05). In conclusion, fiber atrophy plus contractile dysfunction caused diaphragm weakness in HFrEF. Decreased ribosomal proteins and heighted reversible oxidation of protein thiols are candidate mechanisms for atrophy or anabolic resistance as well as loss of specific force in sHFrEF.

Phenotypic heterogeneity by site of infection in surgical sepsis: a prospective longitudinal study.

BACKGROUND: The role of site of infection in sepsis has been poorly characterized. Additionally, sepsis epidemiology has evolved. Early mortality has decreased, but many survivors now progress into chronic critical illness (CCI). This study sought to determine if there were significant differences in the host response and current epidemiology of surgical sepsis categorized by site of infection. STUDY DESIGN: This is a longitudinal study of surgical sepsis patients characterized by baseline predisposition, insult characteristics, serial biomarkers, hospital outcomes, and long-term outcomes. Patients were categorized into five anatomic sites of infection. RESULTS: The 316 study patients were predominantly Caucasian; half were male, with a mean age of 62 years, high comorbidity burden, and low 30-day mortality (10%). The primary sites were abdominal (44%), pulmonary (19%), skin/soft tissue (S/ST, 17%), genitourinary (GU, 12%), and vascular (7%). Most abdominal infections were present on admission and required source control. Comparatively, they had more prolonged proinflammation, immunosuppression, and persistent organ dysfunction. Their long-term outcome was poor with 37% CCI (defined as > 14 in ICU with organ dysfunction), 49% poor discharge dispositions, and 30% 1-year mortality. Most pulmonary infections were hospital-acquired pneumonia. They had similar protracted proinflammation and organ dysfunction, but immunosuppression normalized. Long-term outcomes are similarly poor (54% CCI, 47% poor disposition, 32% 1-year mortality). S/ST and GU infections occurred in younger patients with fewer comorbidities, less perturbed immune responses, and faster resolution of organ dysfunction. Comparatively, S/ST had better long-term outcomes (23% CCI, 39% poor disposition, 13% 1-year mortality) and GU had the best (10% CCI, 20% poor disposition, 10% 1-year mortality). Vascular sepsis patients were older males, with more comorbidities. Proinflammation was blunted with baseline immunosuppression and organ dysfunction that persisted. They had the worst long-term outcomes (38% CCI, 67% poor disposition, 57% 1-year mortality). CONCLUSION: There are notable differences in baseline predisposition, host responses, and clinical outcomes by site of infection in surgical sepsis. While previous studies have focused on differences in hospital mortality, this study provides unique insights into the host response and long-term outcomes associated with different sites of infection.

Validation of algorithms to estimate gestational age at birth in the Medicaid Analytic eXtract-Quantifying the misclassification of maternal drug exposure during pregnancy.

PURPOSE: Accurate ascertainment of gestational age (GA) has been a challenge in perinatal epidemiologic research. To date, no study has validated GA algorithms in Medicaid Analytic eXtract (MAX). METHODS: We linked livebirths of mothers enrolled in Medicaid ≥30 days after delivery in 1999-2010 MAX to state birth certificates. We used clinical/obstetric estimate of gestation on the birth certificates as gold standard to validate claims-based GA algorithms. We calculated the proportions of deliveries with algorithm-estimated GA within 1-/2-weeks of the gold standard, the sensitivity, specificity, and positive/negative predictive value (PPV/NPV) of exposure to select medications during specific gestation windows, and quantified the impact of exposure misclassification on hypothetical relative risk (RR) estimates. RESULTS: We linked 1 336 495 eligible deliveries. Within 1-week agreement was 77%-80% overall and 47%-56% for preterm deliveries. The trimester-specific drug exposure status had high sensitivities and PPVs (88.5%-98.5%), and specificities and NPVs (>99.0%). Assuming a hypothetical RR of 2.0, bias associated with exposure misclassification during first trimester ranged from 10% to 40% under non-differential/differential misclassification assumptions. CONCLUSIONS: Claims-based GA algorithms had good agreement with the gold standard overall, but lower agreement among preterm deliveries, potentially resulting in biased risk estimated for pregnancy exposure evaluations.

Usability of encounter data for Medicaid comprehensive managed care vs traditional Medicaid fee-for-service claims among pregnant women.

BACKGROUND: The completeness of medical encounters capture among Medicaid enrollees in comprehensive managed care (CMC) has been shown to vary across states and years. CMC penetration has grown, and CMC encounter capture specific to pregnancy care is understudied. OBJECTIVES: To compare the completeness of encounter data for pregnant beneficiaries in CMC versus traditional fee-for-service (FFS) in Texas and Florida between 2007 and 2010. METHODS: Using Medicaid Analytic eXtract (MAX) data linked to Florida and Texas birth certificate records, for each state and study year, we compared proportions using seven themes: (a) delivery; (b) prenatal visits; (c) dispensed prescriptions during pregnancy; (d) gestational diabetes and blood glucose testing; (e) antidiabetics and diagnosis of diabetes mellitus; (f) antibiotics for urinary tract infection and outpatient encounter; and (g) bacterial vaginosis and dispensing for metronidazole or clindamycin. We considered CMC data to be acceptable if proportions were no less than 10% below the corresponding (2007 to 2010) FFS control values. RESULTS: Pregnancy-related characteristics of FFS vs CMC denominators were comparable. Proportions for the seven measures among FFS controls ranged from 26% to 98%. In Texas, CMC encounter data met the thresholds for all measures between 2007 and 2010. Florida had usable CMC encounter data starting from 2009 with incomplete medical and pharmacy records in 2007 and 2008. CONCLUSIONS: The quality of CMC encounter data in MAX files for pregnant women varied in Florida and Texas and improved over time. Use of pregnancy-specific measures can aid researchers in selecting states and years with acceptable encounter data quality.

Increased Risk of Acute Pancreatitis with Codeine Use in Patients with a History of Cholecystectomy.

BACKGROUND: Codeine has a spasmodic effect on sphincter of Oddi and is suspected to cause acute pancreatitis in patients with a history of cholecystectomy. AIMS: To assess the association between codeine use and acute pancreatitis in patients with a previous cholecystectomy. METHODS: We conducted a retrospective nested case-control study using the 2005-2015 MarketScan® Commercial Claims and Encounters Database. The cohort included patients aged 18-64; cohort entry began 365 days after cholecystectomy. Odds ratios (ORs) and 95% CIs for acute pancreatitis hospitalization were estimated comparing use of codeine with non-use of codeine. In a secondary analysis, use of codeine was compared with an active comparator: use of non-steroidal anti-inflammatory drugs (NSAIDs). RESULTS: Of the 664,083 patients included in the cohort, 1707 patients were hospitalized for acute pancreatitis (incidence 1.1 per 1000 person-years) and were matched to 17,063 controls. Compared with non-use of codeine, use of codeine was associated with an increased risk of acute pancreatitis (OR 2.67; 95% CI 1.63, 4.36), particularly elevated in the first 15 days of codeine use (OR 5.37; 95% CI 2.70, 10.68). Compared with use of NSAIDs, use of codeine was also associated with an increased risk of acute pancreatitis (OR 2.64; 95% CI 1.54, 4.52). CONCLUSION: Codeine is associated with an increased risk of acute pancreatitis in patients who have previously undergone cholecystectomy; greater clinician awareness of this association is needed.