How Do Prescribing Clinicians Obtain Consent to Initiate Gender-Affirming Hormones?

Purpose: Multiple consent models exist for initiating gender-affirming hormone therapy (GAHT). Our study aim was to examine the variety of approaches utilized by clinicians. Methods: Online and in-person recruitment of clinicians involved in gender-affirming care was undertaken from June 2019 through March 2020. Participants completed an online survey. Results: Of the 175 respondents, 148 prescribed GAHT. Sixty-one (41.2%) prescribed to adults only, 11 (7.4%) to minors only, and 76 (51.4%) prescribed to adults and minors. Of those who prescribed to adults, more than half (n=74, 54.4%) utilized a written consent model, one-fourth only verbal consent (n=33, 24.3%), and one-fifth required an additional mental health assessment (MHA) (n=29, 21.3%). Of those prescribing to minors, most required either written consent (n=39, 44.8%) or an additional MHA (n=35, 40.2%). Only 11 (12.6%) utilized only verbal consent for minors. Rationales provided for requiring an additional MHA in adults included protection from litigation, lack of competence in assessing psychosocial readiness for GAHT, and believing that this is the best way to ensure the patient has processed the information. Practicing in multidisciplinary clinics was associated with not requiring an MHA for adult GAHT. Conclusion: Clinicians across fields are utilizing different models to provide the same treatment, with varying rationales for the same model. As a result, patients receive nonstandard access to care despite similar clinical presentations. Our study highlights an important area for further improvement in GAHT care.

A retrospective study of adverse drug events in anticoagulant administration with relevance to COVID-19.

Initial studies in COVID-19 patients reported lower mortality rates associated with the use of the drug heparin, a widely used anticoagulant. The objective of this analysis was to determine whether there are adverse events associated with the administration of anticoagulants, and specifically how this might apply in patients known to have COVID-19. Data for this study were obtained from the Food and Drug Administration's Adverse Event Reporting System (FAERS) public database and from the NIH's clinical trials website. Proportional Reporting Ratios (PRR) with lower 95% confidence intervals (lower CI) and empirical Bayes geometric mean (EBGM) scores with lower 95% confidence limits were calculated for data from the FAERS database where the adverse events studied mimicked COVID-19 symptoms.

Prevalence and Risk Factors of Major Depression in Patients with Diabetic Retinopathy in a Nationally Representative Survey.

PURPOSE: Evaluate the prevalence and risk factors of depression in diabetic retinopathy (DR). Compare subjective and objective measures of visual function predictivity of depression. METHODS: National Health and Nutrition Examination Survey 2005-2008 participants aged ≥40 who underwent fundus photography, Patient Health Questionnaire (PHQ)-9, and Visual Function Questionnaire (VFQ-25) were included in the study. Multivariable logistic regression was used to evaluate whether DR was a significant risk factor for depression and to evaluate the risk factors for depression in those with DR. RESULTS: A total of 5704 participants, 47% male, and mean age 56.5 years were included in this study. Persons with moderate, severe non-proliferative diabetic retinopathy (NPDR), or proliferative retinopathy (PDR) had higher prevalence of depression than participants with mild retinopathy or no retinopathy (14.3%, 6.9%, 7.0%). Moderate-to-severe NPDR or PDR (OR: 2.36, p = .04) was associated with depression. Among persons with DR, best-corrected visual acuity and HbA1c were not associated with depression. However, self-reported measures of vision were associated with depression: some of the time spent worrying about eyesight (OR: 4.59, p = .010), vision limit activities some of the time (OR: 8.52, p < .001), vision limits activities most/all of the time (OR: 6.99, p < .001). CONCLUSIONS: A significant proportion of patients with DR in the NHANES population had co-morbid major depression. Best corrected visual acuity was not associated with depression in those with DR, while subjective, self-reported measures were associated with depression, suggesting subjective measures are a better determinant of poor mood and low functional status.

Ability of Video Telemetry to Predict Unplanned Hospital Admissions for Single Ventricle Infants.

Background Our Cardiac High Acuity Monitoring Program (CHAMP) uses home video telemetry (HVT) as an adjunct to monitor infants with single ventricle during the interstage period. This study describes the development of an objective early warning score using HVT, for identification of infants with single ventricle at risk for clinical deterioration and unplanned hospital admissions (UHA). Methods and Results Six candidate scoring parameters were selected to develop a pragmatic score for routine evaluation of HVT during the interstage period. We evaluated the individual and combined ability of these parameters to predict UHA. All infants with single ventricle monitored at home by CHAMP between March 2014 and March 2018 were included. Videos obtained within 48 hours before UHA were compared with videos obtained at baseline. We used binary logistic regression models and receiver operating characteristic curves to evaluate the parameters' performance in discriminating the outcome of interest. Thirty-nine subjects with 64 UHA were included. We compared 64 pre-admission videos to 64 paired baseline videos. Scoring was feasible for a mean of 91.6% (83.6%-98%) of all observations. Three different HVT score models were proposed, and a final model composed of respiratory rate, respiratory effort, color, and behavior exhibited an excellent discriminatory capability with an area under the receiver operating characteristic curve of 93% (89%-98%). HVT score of 5 was associated with specificity of 93.8% and sensitivity of 88.7% in predicting UHA. Conclusions We developed a feasible and reproducible HVT score that can serve as a tool to predict UHA in infants with single ventricle. Future directions involve prospective, multicenter validation of this tool.

Detecting Sepsis in an Emergency Department: SIRS vs. qSOFA.

Sepsis is a condition that can progress to serious illness and even death. The diagnosis of sepsis is difficult because no unique biomarker exists. With this, health care providers must rely on clinical diagnostic criteria to guide diagnosis. Systemic Inflammatory Response Syndrome (SIRS) criteria have been used for diagnosis since 1992. The more recent attempt to replace SIRS with the quick Sequential Organ Failure Assessment (qSOFA) for assessment of potentially septic patients is troublesome. The qSOFA was designed as a prognostic and not diagnostic tool. Using established processes of evidence-based medicine, it is shown herein that qSOFA fails to meet the definition of a diagnostic assessment tool. Thus, the SIRS assessment should remain the gold standard tool for detecting patients at risk of "sepsis."

Cavernous Malformation Surgery in the United States: Validation of a Novel International Classification of Disease, 10th Edition, Clinical Modification Code Search Algorithm and Volume-Driven Surgical Outcomes.

OBJECTIVE: The surgical decision-making process for cavernous malformation (CM) must weigh the risks of surgery against the burden of patient symptoms/hemorrhage and anticipated natural history. Here, we sought to internally validate an International Classification of Disease (ICD)-10 search algorithm for CM surgery to use to analyze a nationwide administrative database. METHODS: Institutional records were accessed to test the validity of a novel ICD-10 search algorithm for CM surgery. The algorithm identified patients with positive predictive value (92%), specificity (100%), and sensitivity of 55%. The algorithm was applied to extract our target population from the Nationwide Readmissions Database. Univariate and multivariable analyses were used to identify factors influencing patient outcomes. RESULTS: We identified 1235 operations for supratentorial (87%) or infratentorial (13%) CM surgery from the Nationwide Readmissions Database (2016-2017). The overall rate of adverse disposition and 30-day readmission were 19.7% and 7.5%, respectively. The rate of adverse disposition was significantly higher for infratentorial (vs. supratentorial cases) (34.3% vs. 17.6%, P = 0.001) and brainstem (vs. cerebellar) cases (55% vs. 28%, P = 0.03). Hospital case-volume percentile was associated with decreasing rates of adverse disposition (1-74th: 22%, 75th: 16%, 90th: 13%, 95th: 7%). Treatment at HVCs was also associated with shorter average length of stay (4.6 vs. 7.3 days, P < 0.001) without significant changes to average cost of hospitalization (P = 0.60). CONCLUSIONS: Our ICD-10 coding algorithm reliably identifies CM surgery with minimal false positives. Outcomes were influenced by patient age, clinical presentation, location of CM, and experience of institution. Centralization of care may improve outcomes and warrants further investigation.

Risk Factors for Cerebral Vasospasm in Aneurysmal Subarachnoid Hemorrhage: A Population-Based Study of 8346 Patients.

BACKGROUND: A recent systematic review and meta-analysis found that there was a lack of consensus regarding risk factors for cerebral vasospasm in aneurysmal subarachnoid hemorrhage (aSAH). OBJECTIVE: To identify risk factors associated with increased likelihood of cerebral vasospasm after aSAH using the largest, all-payer, inpatient database in the United States. METHODS: The Nationwide Readmissions Database (2016) was queried using International Classification of Diseases, Tenth Revision codes to identify patients (age ≥18 years) treated (coiling or clipping) for aSAH. Exposure variables included demographics, comorbidities, location and clinical grade of aSAH, treatment type, and laboratory anomalies. Multivariable analysis was conducted to identify factors independently associated with cerebral vasospasm (ICD-10 code I67.84). RESULTS: The rate of vasospasm was 28.1% in 8346 patients with treated aSAH. In multivariable analysis, vasospasm risk was inversely proportional to age (P < 0.001). Substance abuse, particularly tobacco smoking and cocaine, was associated with vasospasm (P < 0.05). Advanced SAH severity (Hunt and Hess grade ≥2) approximately doubled risk of vasospasm (P < 0.001). Poor hemodynamic status, including anemia (odds ratio [OR], 1.8), hypovolemia (OR, 1.6), and hypotension (OR, 1.4), was correlated with vasospasm. Laboratory abnormalities, including leukocytosis (OR, 1.3), hyponatremia (OR, 1.4), and hypokalemia (OR, 1.3), were associated with vasospasm (all P < 0.05). CONCLUSIONS: In the first nationwide analysis of cerebral vasospasm, risk factors included younger age, female sex, smoking history, hemodynamic compromise, and clinical severity of aSAH. Recently proposed biomarkers, including leukocytosis and hypokalemia, were supported by our findings. This study may assist risk stratification and earlier detection of vasospasm.

Readmission following extracranial-intracranial bypass surgery in the United States: nationwide rates, causes, risk factors, and volume-driven outcomes.

OBJECTIVE: Extracranial-intracranial (EC-IC) bypass surgery remains an important treatment option for patients with moyamoya disease (MMD), intracranial arteriosclerotic disease (ICAD) with symptomatic stenosis despite the best medical management, and complex aneurysms. The therapeutic benefit of cerebral bypass surgery depends on optimal patient selection and the minimization of periprocedural complications. The nationwide burden of readmissions and associated complications following EC-IC bypass surgery has not been previously described. Therefore, the authors sought to analyze a nationwide database to describe the national rates, causes, risk factors, complications, and morbidity associated with readmission following EC-IC bypass surgery for MMD, ICAD, and aneurysms. METHODS: The Nationwide Readmissions Database (NRD) was queried for the years 2010-2014 to identify patients who had undergone EC-IC bypass for MMD, medically failed symptomatic ICAD, or unruptured aneurysms. Predictor variables included demographics, preexisting comorbidities, indication for surgery, and hospital bypass case volume. A high-volume center (HVC) was defined as one that performed 10 or more cases/year. Outcome variables included perioperative stroke, discharge disposition, length of stay, total hospital costs, and readmission (30 days, 90 days). Multivariable analysis was used to identify predictors of readmission and to study the effect of treatment at HVCs on quality outcomes. RESULTS: In total, 2500 patients with a mean age of 41 years were treated with EC-IC bypass surgery for MMD (63.1%), ICAD (24.5%), or unruptured aneurysms (12.4%). The 30- and 90-day readmission rates were 7.5% and 14.0%, respectively. Causes of readmission included new stroke (2.5%), wound complications (2.5%), graft failure (1.5%), and other infection (1.3%). In the multivariable analysis, risk factors for readmission included Medicaid/self-pay (OR 1.6, 95% CI 1.1-2.4, vs private insurance), comorbidity score (OR 1.2, 95% CI 1.1-1.4, per additional comorbidity), and treatment at a non-HVC (OR 1.9, 95% CI 1.1-3.0). Treatment at an HVC (17% of patients) was associated with significantly lower rates of nonroutine discharge dispositions (13.4% vs 26.7%, p = 0.004), ischemic stroke within 90 days (0.8% vs 2.9%, p = 0.03), 30-day readmission (3.9% vs 8.2%, p = 0.03), and 90-day readmission (8.6% vs 15.2%, p = 0.01). These findings were confirmed in a multivariable analysis. The authors estimate that centralization to HVCs may result in 333 fewer nonroutine discharges (50% reduction), 12,000 fewer hospital days (44% reduction), 165 fewer readmissions (43%), and a cost savings of $15.3 million (11% reduction). CONCLUSIONS: Readmission rates for patients after EC-IC bypass are comparable with those after other common cranial procedures and are primarily driven by preexisting comorbidities, socioeconomic status, and treatment at low-volume centers. Periprocedural complications, including stroke, graft failure, and wound complications, occurred at the expected rates, consistent with those in prior clinical series. The centralization of care may significantly reduce perioperative complications, readmissions, and hospital resource utilization.

Survey of Experiences of Transgender and Gender Nonbinary Patients During Imaging Encounters and Opportunities for Improvement.

OBJECTIVE. The purpose of this study was to assess the inclusivity of imaging centers for transgender and gender nonbinary (TGNB) patients and those patients' level of comfort during imaging center visits. MATERIALS AND METHODS. A survey of TGNB persons was developed to explore their experiences during imaging encounters. The survey was distributed via purposive snowball sampling with link sharing on social media and listservs as well as at TGNB community events and conferences during the period from January to December 2018. RESULTS. Of the 555 respondents who initiated the survey, 363 (65.4%) completed it and satisfied inclusion criteria. Of the 363, 257 (70.8%) reported having had at least one negative imaging encounter. Nearly one-third (32.4%, 116/358) had to instruct imaging facility staff about TGNB persons to receive appropriate care. Ultrasound examinations and image-guided procedures contributed to the highest rates of unexpected emotional discomfort (49.1% [109/222] and 38.1% [16/42], respectively). Noninvasive modalities also contributed to unexpected emotional discomfort, with the highest percentage of patients (23.5%) reporting emotional discomfort during MRI. Many imaging environments were considered unwelcoming toward TGNB patients, with 45.2% (164/363) of respondents noting no visible reading materials or other postings that could be considered to be affirming to lesbian, gay, bisexual, transgender, or queer patients and 39.1% (142/363) noting a lack of all-gender or gender-neutral restrooms. CONCLUSION. To our knowledge, our data provide the largest documentation and first quantification of the experiences of TGNB patients during imaging encounters. The data show several aspects of imaging encounters that may contribute toward negative experiences for TGNB patients, which may be improved through education of imaging personnel in TGNB cultural competency, redesign of facilities with sensitivity toward TGNB persons, and incorporation of TGNB patient feedback in the adoption of departmental policies.

Insurance Does Not Affect Adverse Events While Awaiting Surgery for Ankle Trauma in One System.

INTRODUCTION: Ankle injuries that are not properly cared for can have devastating effects on a patient's health and ability to maintain an active lifestyle. Recommended outpatient surgery may be difficult to obtain for many groups of patients, including those without insurance or minority races. Patients who are of low socioeconomic status also have worse outcomes following trauma. The purpose of this study was to examine whether insurance status impacts the number of adverse events that patients face prior to receiving surgical treatment following an emergency department (ED) visit for an acute ankle injury. METHODS: We conducted a retrospective chart review at two medical centers within the same healthcare system. The sample included 192 patients presenting to the ED with an unstable ankle injury between October 1, 2015- May 1, 2018. We used chi-square and t-test analysis to determine differences in rates of adverse events occurring while awaiting surgery. RESULTS: Few (4%) patients presented as being self-pay. Neither Medicare (χ2 (1) (N = 192) = 2.389, p = .122), Medicaid (χ2 (1), (N = 192) = .084, p = .772), other insurances (χ2 (1) (N = 192) = .567, p = .452), or private insurance (χ2 (1) (N=192) = .000, p = .982) was associated with a difference in rates of adverse events. Likewise, gender (χ2 (1) (N = 192) = .402, p = .526), race (χ2 (3) (N = 192) = 2.504, p = .475), and all other demographic variables failed to show a difference in occurrence of adverse events. Those admitted to the hospital did show a lower rate of adverse events compared to those sent home from the ED (χ2 (1) (N = 192) = 5.452, p = .020). Sampled patients were admitted to the hospital at a high rate (49%). CONCLUSION: The sampled facilities did not have adverse event rates that differed based on insurance status or demographic features. These facilities, with hospital-based subsidy programs and higher than expected admission rates, may manage their vulnerable populations well and may indicate their efforts to eliminate health disparity are effective.

High prevalence of comorbid autoimmune diseases in adults with type 1 diabetes from the HealthFacts database.

BACKGROUND: Patients with type 1 diabetes (T1D) are at risk for other autoimmune diseases (ie, polyautoimmunity). The prevalence and risk factors of this phenomenon have been underreported in adults and ethnic minorities, and data are lacking regarding non-endocrine autoimmune diseases. METHODS: Study population data were gathered from HealthFacts, a deidentified patient database compiled from electronic medical records systems in the US. Patients with an International Classification of Diseases diagnosis code specifying T1D were included in the study, whereas those with a diagnosis of type 2 diabetes were excluded. RESULTS: The cross-sectional study cohort comprised 158 865 adults with T1D (mean [±SD] age 51.4 ± 18.9 years, 52.5% female). The most common autoimmune diseases were thyroid disease (20.1%), systemic rheumatic diseases (3.4%), rheumatoid arthritis specifically (2.0%), and gastrointestinal autoimmune diseases (1.4%). Most of the autoimmune diseases were more common in women (eg hypothyroidism, hyperthyroidism, celiac disease, rheumatoid arthritis, lupus, and Sjögren syndrome). Caucasians were more likely than other ethnicities to have an additional autoimmune disease. The prevalence of autoimmune diseases increased with increasing age, significantly in women, such that 38.5% of women over 80 years of age had an additional autoimmune disease, compared with 17.9% of women aged ≤29 years. CONCLUSIONS: Additional autoimmunity represents a significant comorbidity in patients with T1D. Autoimmune diseases are more common in Caucasians and in women, and increase with age. Clinicians treating patients with T1D should be aware of the risk factors for additional autoimmune diseases.

Diagnosis and disposition are changed when board-certified emergency physicians use CT for non-traumatic abdominal pain.

OBJECTIVES: To determine the effect of abdominal computed tomographic (CT) scan results on diagnosis and disposition of patients with non-traumatic abdominal pain who were evaluated by board-certified emergency physicians (EPs). METHODS: Prospective, observational study conducted at a safety-net facility with an emergency medicine residency and 65000 annual adult visits. Patients with non-traumatic abdominal pain who underwent an abdominal CT from 3/2011 through 8/2011 were included. Decision to obtain CT was made by the EP. The computer order entry system required the EP to report the most likely diagnosis, and the management and disposition plan. After CT results, the same EP electronically again entered the most likely diagnosis and the planned management and disposition. CTs were interpreted by an attending radiologist. Descriptive statistics and χ(2) tests were used. RESULTS: Six hundred twenty-nine patients were entered and 547 remained after exclusions; 298 (54%) subjects had a change in diagnosis. In 6 categories, there was a statistically significant change, with non-specific abdominal pain the most common(P < .001); followed by renal colic (P < .001), appendicitis (P < .001), diverticulitis (P < .001), small bowel obstruction (P < .029), and gynecologic process (P < .001). The most common disposition plan was "admit for observation," which was reported in 262 patients and remained in only 122 post CT (47%); 301 (54%) patients whose initial plan was admission were ultimately managed otherwise. CONCLUSIONS: Abdominal CT use by board certified EPs for nontraumatic abdominal pain changed diagnosis and disposition, with more sent home in lieu of admission. Diagnostic accuracy did not appear to be related to years of clinical experience.