Early mortality benefit with COVID-19 convalescent plasma: a matched control study.

Convalescent plasma can provide passive immunity during viral outbreaks, but the benefit is uncertain for the treatment of novel coronavirus disease 2019 (COVID-19). Our goal is to assess the efficacy of COVID-19 convalescent plasma (CCP). In all, 526 hospitalized patients with laboratory-confirmed SARS-CoV-2 at an academic health system were analyzed. Among them, 263 patients received CCP and were compared to 263 matched controls with standard treatment. The primary outcome was 28-day mortality with a subanalysis at 7 and 14 days. No statistical difference in 28-day mortality was seen in CCP cases (25·5%) compared to controls (27%, P = 0·06). Seven-day mortality was statistically better for CCP cases (9·1%) than controls (19·8%, P < 0·001) and continued at 14 days (14·8% vs. 23·6%, P = 0·01). After 72 h, CCP transfusion resulted in transitioning from nasal cannula to room air (median 4 days vs. 1 day, P = 0·02). The length of stay was longer in CCP cases than controls (14·3 days vs. 11·4 days, P < 0·001). Patients with COVID-19 who received CCP had a decreased risk of death at 7 and 14 days, but not 28 days after transfusion. To date, this is the largest study demonstrating a mortality benefit for the use of CCP in patients with COVID-19 compared to matched controls.

Major acute cardiovascular events in patients with inflammatory bowel disease.

BACKGROUND: Systemic inflammation and immune-mediated diseases have been associated with ischemic heart disease in addition to traditional risk factors. In this study, we investigate associations between inflammatory bowel disease (IBD) and acute cardiovascular events. METHODS: An observational study where patient data were extracted from our health system patient pool of 3 917 894. Propensity scores were calculated for all 15 292 patients (0.39%) with IBD to assemble a 1:1 matched cohort balanced for age, gender, race and known cardiovascular risk factors including hypertension, hyperlipidemia, diabetes mellitus and smoking (current and former). Secondary analyses were performed independently for 6658 patients with ulcerative colitis and 9406 patients with Crohn's disease. ICD-9 and ICD-10 codes were used to identify cardiovascular risk factors and outcomes. RESULTS: Matched patients (n = 30 584) had a mean age of 51 years, with 58% being women, and 63% Caucasian. During the median follow-up of 4.4 years, all-cause mortality was observed in 1.7 versus 1.2% of patients from IBD and non-IBD groups, respectively [hazard ratio, 1.31; 95% confidence interval (CI), 1.08-1.58; P = 0.005]. Combined outcome for myocardial infarction or cardiovascular mortality was noted in 2.3 and 2.1% from IBD and non-IBD groups, respectively (hazard ratio, 1.04; 95% CI, 0.90-1.21; P = 0.588), while hazard ratios for cardiovascular mortality, myocardial infarction and unstable angina were 1.04 (0.74-1.47; P = 0.833), 1.05 (0.89-1.23; P = 0.591) and 1.10 (0.83-1.46; P = 0.524), respectively. CONCLUSIONS: Among patients with IBD, incidence of acute coronary events did not show a statistically significant difference when compared to the matched cohort.

Recruiting Control Participants into Stroke Biomarker Studies.

The number of scientists using -omics technologies to investigate biomarkers with the potential to gauge risk and aid in the diagnosis, treatment, and prognosis of stroke continues to rise, yet there are few resources to aid investigators in recruiting control participants. In this review, we describe two major strategies to match control participants to a stroke cohort-propensity score matching and one-to-one matching-including statistical approaches to gauge the balance between groups. We then explore the advantages and disadvantages of traditional recruitment methods including approaching spouses of enrolled stroke participants, direct recruitment from clinics, community outreach events, approaching retirement communities, and buying samples from a 3rd party vendor. Newer methods to identify controls by screening the electronic health record and using an online screening questionnaire are also described. Finally, we cover compensation for control participants and special considerations. The hope is that this review will serve as a roadmap whereby an investigator can successfully tailor their control recruitment strategy to the research question at hand and the local research environment. While this review is focused on blood-based biomarker studies, the principles will apply to investigators studying a broad range of biological materials.

Redesigning ambulatory care management for uncontrolled type 2 diabetes: a prospective cohort study of the impact of a Boot Camp model on outcomes.

Objective: Type 2 diabetes care management (DCM) is challenging. Few studies report meaningful improvements in clinical care settings, warranting DCM redesign. We developed a Boot Camp to provide timely, patient-centered, technology-enabled DCM. Impact on hemoglobin A1c (HbA1c), emergency department (ED) visits and hospitalizations among adults with uncontrolled type 2 diabetes were examined. Research design and methods: The intervention was designed using the Practical Robust Implementation and Sustainability Model to embed elements of the chronic care model. Adults with HbA1c>9% (75 mmol/mol) enrolled between November 2014 and November 2017 received diabetes education and medication management by diabetes educators and nurse practitioners via initial clinic and subsequent weekly virtual visits, facilitated by near-real-time blood glucose transmission for 90 days. HbA1c and risk for ED visits and hospitalizations at 90 days, and potential savings from reducing avoidable medical utilizations were examined. Boot Camp completers were compared with concurrent, propensity-matched chart controls receiving usual DCM in primary care practices. Results: A cohort of 366 Boot Camp participants plus 366 controls was analyzed. Participants were 79% African-American, 63% female and 59% Medicare-insured or Medicaid-insured and mean age 56 years. Baseline mean HbA1c for cases and controls was 11.2% (99 mmol/mol) and 11.3% (100 mmol/mol), respectively. At 90 days, HbA1c was 8.1% (65 mmol/mol) and 9.9% (85 mmol/mol), p<0.001, respectively. Risk for 90-day all-cause hospitalizations decreased 77% for participants and increased 58% for controls, p=0.036. Mean potential for monetization of US$3086 annually per participant for averted hospitalizations were calculated. Conclusions: Redesigning diabetes care management using a pragmatic technology-enabled approach supported translation of evidence-based best practices across a mixed-payer regional healthcare system. Diabetes educators successfully participated in medication initiation and titration. Improvement in glycemic control, reduction in hospitalizations and potential for monetization was demonstrated in a high-risk cohort of adults with uncontrolled type 2 diabetes. Trial registration number: NCT02925312.

Leveraging the electronic health record to eliminate hepatitis C: Screening in a large integrated healthcare system.

Highly efficacious and tolerable treatments that cure hepatitis C viral (HCV) infection exist today, increasing the feasibility of disease elimination. However, large healthcare systems may not be fully prepared for supporting recommended actions due to knowledge gaps, inadequate infrastructure and uninformed policy direction. Additionally, the HCV cascade of care is complex, with many embedded barriers, and a significant number of patients do not progress through the cascade and are thus not cured. The aim of this retrospective cohort study was to evaluate a large healthcare system's HCV screening rates, linkage to care efficiency, and provider testing preferences. Patients born during 1945-1965, not previously HCV positive or tested from within the Electronic Health Record (EHR), were identified given that three-quarters of HCV-infected persons in the United States are from this Birth Cohort (BC). In building this HCV testing EHR prompt, non-Birth Cohort patients were excluded as HCV-specific risk factors identifying this population were not usually captured in searchable, structured data fields. Once completed, the BC prompt was released to primary care locations. From July 2015 through December 2016, 11.5% of eligible patients (n = 9,304/80,556) were HCV antibody tested (anti-HCV), 3.8% (353/9,304) anti-HCV positive, 98.1% (n = 311/317) HCV RNA tested, 59.8% (n = 186/311) HCV RNA positive, 86.6% (161/186) referred and 76.4% (n = 123/161) seen by a specialist, and 34.1% (n = 42/123) cured of their HCV. Results from the middle stages of the cascade in this large healthcare system are encouraging; however, entry into the cascade-HCV testing-was performed for only 11% of the birth cohort, and the endpoint-HCV cure-accounted for only 22% of all infected. Action is needed to align current practice with recommendations for HCV testing and treatment given that these are significant barriers toward elimination.

Hyponatremia Is Associated With Increased Osteoporosis and Bone Fractures in Patients With Diabetes With Matched Glycemic Control.

CONTEXT: Patients with diabetes mellitus are at increased risk for bone fragility fracture secondary to multiple mechanisms. Hyperglycemia can induce true dilutional hyponatremia. Hyponatremia is associated with gait instability, osteoporosis, and increased falls and bone fractures, and studies suggest that compromised bone quality with hyponatremia may be independent of plasma osmolality. We performed a case-control study of patients with diabetes mellitus matched by median glycated hemoglobin (HbA1c) to assess whether hyponatremia was associated with increased risk of osteoporosis and/or fragility fracture. DESIGN: Osteoporosis (n = 823) and fragility fracture (n = 840) cases from the MedStar Health database were matched on age of first HbA1c ≥6.5%, sex, race, median HbA1c over an interval from first HbA1c ≥6.5% to the end of the encounter window, diabetic encounter window length, and type 1 vs type 2 diabetes mellitus with controls without osteoporosis (n = 823) and without fragility fractures (n = 840), respectively. Clinical variables, including coefficient of glucose variation and hyponatremia (defined as serum [Na+] <135 mmol/dL within 30 days of the end of the diabetic window), were included in a multivariate analysis. RESULTS: Multivariate conditional logistic regression models demonstrated that hyponatremia within 30 days of the outcome measure was independently associated with osteoporosis and fragility fractures (osteoporosis OR 3.09; 95% CI, 1.37 to 6.98; fracture OR, 6.41; 95% CI, 2.44 to 16.82). CONCLUSIONS: Our analyses support the hypothesis that hyponatremia is an additional risk factor for osteoporosis and fragility fracture among patients with diabetes mellitus.

The impact of environmental ultraviolet exposure on the clinical course of mycosis fungoides.

BACKGROUND: As phototherapy plays an important role in the treatment of early-stage mycosis fungoides (MF), it is possible that environmental ultraviolet (UV) exposure affects the natural history of the disease. OBJECTIVE: To assess the impact of environmental UV exposure on the clinical course of MF. METHODS: The National Solar Radiation Database was used to identify the top and bottom registries for UV exposure from the Surveillance, Epidemiology, and End Results-18 database. Incidence and survival were determined. RESULTS: The high-UV cohort had a 30% lower risk of developing MF than did the low-UV cohort (hazard ratio, 1.3; 95% confidence interval, 1.20-1.41; P < .001). When stratified by stage and race, this difference was appreciable only among those with early-stage disease and white race. There was no difference in survival between the high- and low-UV cohorts (P = .098); however, a small difference was observed among those with early-stage disease and white race, favoring high UV exposure. LIMITATIONS: Retrospective design, use of the National Solar Radiation Database as a surrogate for individual sunlight exposure. CONCLUSION: It is possible that environmental solar UV exposure may play a role in controlling early-stage MF among patients with photosensitive features.

Hyponatremia and the risk of kidney stones: A matched case-control study in a large U.S. health system.

Kidney stones impose a large and increasing public health burden. Previous studies showed that hyponatremia is associated with an increased risk of osteoporosis and bone fractures, which are also known to be associated with kidney stones. However, the relation between hyponatremia and kidney stones is not known. To assess the relation between hyponatremia and kidney stones, we designed a matched case-control study by using the electronic health records of the MedStar Health system with more than 3.4 million unique patient records as of March 2016. Data were extracted for clinical factors of patients with kidney stones (cases) and those without kidney stones (controls). Cases (n = 20,199) and controls (n = 20,199) were matched at a 1:1 ratio for age, sex, race, and the duration of encounter window. Case and control exposures for each of the hyponatremia variables were defined by serum sodium laboratory measurements reported within the encounter windows, and divided into 3 categories: prior hyponatremia, recent hyponatremia, and persistent hyponatremia. In the final conditional logistic models adjusted for potential confounders, the risk of kidney stones significantly increased in both recent and persistent hyponatremia categories: prior hyponatremia odds ratio (OR) 0.93 (95% confidence interval [CI], 0.86-1.00); recent hyponatremia OR 2.02 (95% CI, 1.76-2.32); persistent hyponatremia OR 6.25 (95% CI, 3.27-11.96). In conclusion, chronic persistent hyponatremia is a significant and clinically important risk factor for kidney stones in patients in the U.S.

Acute Kidney Injury and In-Hospital Mortality after Coronary Artery Bypass Graft versus Percutaneous Coronary Intervention: A Nationwide Study.

BACKGROUND: Post-procedural acute kidney injury (AKI) is associated with significantly increased short- and long-term mortalities, and renal loss. Few studies have compared the incidence of post-procedural AKI and in-hospital mortality between 2 major modalities of revascularization - coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) - and results have been inconsistent. METHODS: We generated a propensity score-matched cohort that includes a total of 286,670 hospitalizations with multi-vessel coronary disease undergoing CABG or PCI (2004-2012) from the National Inpatient Sample database. We compared incidence of AKI, AKI requiring renal replacement therapy (RRT), in-hospital mortality, hospital stay, and charges between CABG and PCI groups. RESULTS: The incidence of AKI after CABG was higher than PCI (8.9 vs. 4.5%, OR 2.05, 95% CI 1.99-2.12, p < 0.001). The incidence of AKI requiring RRT was also higher after CABG (1.1 vs. 0.5%, OR 2.14, 95% CI 1.96-2.34, p < 0.001). Likewise, in-hospital mortality was higher after CABG than PCI (2.0 vs. 1.4%, OR 1.44, 95% CI 1.35-1.52, p < 0.001). Among patients with pre-existing chronic kidney disease (stages I-IV), those undergoing CABG was associated with 2.0-2.3-fold higher odds of developing AKI than those undergoing PCI. The patients treated with CABG had a significantly longer hospital stay and higher hospital charges. CONCLUSIONS: Patients undergoing CABG are associated with (1) increased risk of developing post-procedural AKI, (2) higher likelihood of receiving RRT, and (3) worse short-term survival. Long-term renal outcome remains to be studied.

Hyponatremia Is Associated With Increased Osteoporosis and Bone Fractures in a Large US Health System Population.

CONTEXT: The significance of studies suggesting an increased risk of bone fragility fractures with hyponatremia through mechanisms of induced bone loss and increased falls has not been demonstrated in large patient populations with different types of hyponatremia. OBJECTIVE: This matched case-control study evaluated the effect of hyponatremia on osteoporosis and fragility fractures in a patient population of more than 2.9 million. DESIGN, SETTING, AND PARTICIPANTS: Osteoporosis (n = 30 517) and fragility fracture (n = 46 256) cases from the MedStar Health database were matched on age, sex, race, and patient record length with controls without osteoporosis (n = 30 517) and without fragility fractures (n = 46 256), respectively. Cases without matched controls or serum sodium (Na(+)) data or with Na(+) with a same-day blood glucose greater than 200 mg/dL were excluded. MAIN OUTCOME MEASURES: Incidence of diagnosis of osteoporosis and fragility fractures of the upper or lower extremity, pelvis, and vertebrae were the outcome measures. RESULTS: Multivariate conditional logistic regression models demonstrated that hyponatremia was associated with osteoporosis and/or fragility fractures, including chronic [osteoporosis: odds ratio (OR) 3.97, 95% confidence interval (CI) 3.59-4.39; fracture: OR 4.61, 95% CI 4.15-5.11], recent (osteoporosis: OR 3.06, 95% CI 2.81-3.33; fracture: OR 3.05, 95% CI 2.83-3.29), and combined chronic and recent hyponatremia (osteoporosis: OR 12.09, 95% CI 9.34-15.66; fracture: OR 11.21, 95% CI 8.81-14.26). Odds of osteoporosis or fragility fracture increased incrementally with categorical decrease in median serum Na(+). CONCLUSIONS: These analyses support the hypothesis that hyponatremia is a risk factor for osteoporosis and fracture. Additional studies are required to evaluate whether correction of hyponatremia will improve patient outcomes.

Effect of facial rejuvenation surgery on perceived attractiveness, femininity, and personality.

IMPORTANCE: To date, the conversation about facial rejuvenation surgery has focused on one goal: youthfulness. However, human beings are judged throughout life based on many other characteristics and personal qualities conveyed by their faces. The term facial profiling has been used to describe this act of determining personality attributes through visual observation. OBJECTIVES: To introduce the concept of facial profiling to the surgical literature and to evaluate and quantify the changes in personality perception that occur with facial rejuvenation surgery. DESIGN, SETTING, AND PARTICIPANTS: This study was a retrospective evaluation of preoperative and postoperative photographs of 30 white female patients who underwent facial rejuvenation surgery between January 1, 2009, and December 31, 2013. Procedures included rhytidectomy (face-lift), upper blepharoplasty, lower blepharoplasty, eyebrow-lift, neck-lift, and/or chin implant. The 60 photographs (30 preoperative and 30 postoperative) of these patients were split into 6 groups, each with 5 preoperative and 5 postoperative photographs. The same patient's preoperative and postoperative photographs were not included in any single group to avoid any recall bias. At least 24 individuals rated each photograph for 6 personality traits (aggressiveness, extroversion, likeability, trustworthiness, risk seeking, and social skills), as well as for attractiveness and femininity. The raters were blinded as to the intent of the study. MAIN OUTCOMES AND MEASURES: Ratings of personality traits, attractiveness, and femininity. RESULTS: Of the 8 traits that were evaluated, analysis revealed 4 traits with statistically significant improvements when comparing preoperative and postoperative scores: likeability (+0.36, P < .01), social skills (+0.38, P = .01), attractiveness (+0.36, P = .01), and femininity (+0.39, P = .02). Improvement in scores for perceived trustworthiness (+0.22, P = .06), aggressiveness (-0.14, P = .32), extroversion (+0.19, P = .14), and risk seeking (+0.10, P = .27) did not demonstrate statistically significant changes. CONCLUSIONS AND RELEVANCE: Facial plastic surgery changes the perception of patients by those around them. Traditionally, these interventions have focused on improvements in youthful appearance, but this study illuminates the other dimensions of a patient's facial profile that are influenced by facial rejuvenation surgery. The data in this sample population demonstrate an increase in the perception of likeability, social skills, attractiveness, and femininity. To our knowledge, this is the first study in the surgical literature to evaluate these broader outcome measures after facial rejuvenation surgery. LEVEL OF EVIDENCE: NA.

Postoperative wound dehiscence: Predictors and associations.

The Agency for Healthcare Research and Quality patient safety indicators (PSI) were developed as a metric of hospital complication rates. PSI-14 measures postoperative wound dehiscence and specifically how often a surgical wound in the abdominal or pelvic area fails to heal after abdominopelvic surgery. Wound dehiscence is estimated to occur in 0.5-3.4% of abdominopelvic surgeries, and carries a mortality of up to 40%. Postoperative wound dehiscence has been adopted as a surrogate safety outcome measure as it impacts morbidity, length of stay, healthcare costs and readmission rates. Postoperative wound dehiscence cases from the Nationwide Inpatient Sample demonstrate 9.6% excess mortality, 9.4 days of excess hospitalization and $40,323 in excess hospital charges relative to matched controls. The purpose of the current study was to investigate the associations between PSI-14 and measurable medical and surgical comorbidities using the Explorys technology platform to query electronic health record data from a large hospital system serving a diverse patient population in the Washington, DC and Baltimore, MD metropolitan areas. The study population included 25,636 eligible patients who had undergone abdominopelvic surgery between January 1, 2008 and December 31, 2012. Of these cases, 786 (2.97%) had postoperative wound dehiscence. Patient-associated comorbidities were strongly associated with PSI-14, suggesting that this indicator may not solely be an indicator of hospital safety. There was a strong association between PSI-14 and opioid use after surgery and this finding merits further investigation.

Cross-sectional evaluation of noninvasively detected skin intrinsic fluorescence and mean hemoglobin a1c in type 1 diabetes.

BACKGROUND: This study evaluated the relationship between skin intrinsic fluorescence (SIF) and long-term mean hemoglobin A1c (HbA1c) in individuals with type 1 diabetes. SUBJECTS AND METHODS: We undertook a cross-sectional analysis of 172 individuals with type 1 diabetes followed longitudinally with HbA1c data available over an average of 16.6 years. SIF was evaluated cross-sectionally using the SCOUT DS device (VeraLight Inc., Albuquerque, NM) and correlated with most recent HbA1c and long-term mean HbA1c. Potential determinants of this relationship, including age, gender, smoking status, duration of diabetes, and renal function, were also evaluated. RESULTS: Age-adjusted skin intrinsic fluorescence significantly correlated with long-term mean HbA1c (R=0.44, P<0.0001). In contrast, there was no significant relationship between SIF and most recent HbA1c (R=0.14, P=0.075). The best-fit model describing the relationship between SIF and mean HbA1c controlled for factors of age, duration of disease, renal function, and site of study conduct. Controlling for these factors was also important in understanding the relationship between most recent HbA1c and SIF. Evaluating longer-term HbA1c data also strengthened the relationship between SIF and mean HbA1c. In the presence of renal dysfunction or damage, as indicated by an estimated glomerular filtration rate of <60 mL/min/1.73 m2 or presence of gross proteinuria, there was no significant correlation between SIF and mean HbA1c. CONCLUSIONS: Noninvasive detection of SIF significantly correlates with long-term mean HbA1c, providing insight into long-term glycemic exposure. Age, duration of diabetes, and renal function are potential contributors to this relationship.

Poor long-term blood pressure control after intracerebral hemorrhage.

BACKGROUND AND PURPOSE: Hypertension is the most important risk factor associated with intracerebral hemorrhage. We explored racial differences in blood pressure (BP) control after intracerebral hemorrhage and assessed predictors of BP control at presentation, 30 days, and 1 year in a prospective cohort study. METHODS: Subjects with spontaneous intracerebral hemorrhage were identified from the DiffErenCes in the Imaging of Primary Hemorrhage based on Ethnicity or Race (DECIPHER) Project. BP was compared by race at each time point. Multivariable linear regression was used to determine predictors of presenting mean arterial pressure, and longitudinal linear regression was used to assess predictors of mean arterial pressure at follow-up. RESULTS: A total of 162 patients were included (mean age, 59 years; 53% male; 77% black). Mean arterial pressure at presentation was 9.6 mm Hg higher in blacks than whites despite adjustment for confounders (P=0.065). Fewer than 20% of patients had normal BP (<120/80 mm Hg) at 30 days or 1 year. Although there was no difference at 30 days (P=0.331), blacks were more likely than whites to have Stage I/II hypertension at 1 year (P=0.036). Factors associated with lower mean arterial pressure at follow-up in multivariable analysis were being married at baseline (P=0.032) and living in a facility (versus personal residence) at the time of BP measurement (P=0.023). CONCLUSIONS: Long-term BP control is inadequate in patients after intracerebral hemorrhage, particularly in blacks. Further studies are needed to understand the role of social support and barriers to control to identify optimal approaches to improve BP in this high-risk population.