Real-world assessment of anaphylaxis and eosinophilic esophagitis with 12 SQ house dust mite SLIT-tablet sublingual immunotherapy.

Background: Sublingual immunotherapy (SLIT) with 12 SQ house dust mile SLIT-tablet (HDM SLIT-tablet) for dust mite-induced perennial allergic rhinitis is reported as effective and safe. Although serious allergic reactions (SARs) and eosinophilic esophagitis (EoE) have infrequently occurred under trial conditions, the safety of HDM SLIT-tablet challenge under real-world conditions is unknown. Objective: Our aim was to estimate the incidence of SARs and EoE due to HDM SLIT-tablet challenge. Methods: Through use of administrative data from Kaiser Permanente Southern California, this prospective observational study identified patients newly administered HDM SLIT-tablet with follow-up until SLIT discontinuation or end of study. Suspected cases of SARs and EoE were detected by using International Classification of Diseases, 10th Revision, diagnosis and Current Procedural Terminology procedure codes and medication dispensing records. A 3-member clinical review committee of allergists adjudicated suspected reactions. The incidence rate of confirmed SARs and EoE per 1000 person years of exposure were determined. Results: A total of 521 patients (93.9% adult and 6.1% pediatric) were exposed to HDM SLIT-tablet challenge from January 2018 through May 2023, for 440.4 person years of exposure. The patients' average age (SD) was 39.3 (14.1) years, 58.7% were female, 44.3% were non-Hispanic White, 40.3% had asthma, and 15.0% had gastroesophageal reflux disease. A SAR occurred in 1 adult patient, and during initial HDM SLIT-tablet challenge, SARs occurred in 2 pediatric adolescents, for an overall incidence of 6.8 SARs per 1000 patient years (95% CI = 2.2-21.1). EoE occurred in 1 adult patient, for an overall incidence of 2.3 cases of EoE per 1000 patient years (95% CI = 0.3-16.1). Conclusions: This real-world study demonstrated that SARs and EoE were infrequent events with HDM SLIT-tablet use, supporting the safety of HDM SLIT-tablets and need for physician supervision with initial challenge.

COVID-19-related Peripheral Arterial Thrombosis Treated in a Large Health Maintenance Organization.

BACKGROUND: COVID-19 was initially identified as an acute respiratory disease, but it was quickly recognized that multiple organ systems could be affected. Venous thrombosis and pulmonary embolism have been well reported. However, there is a paucity of data on COVID-19-related arterial thrombosis. We examined the incidence, characteristics, treatment, and outcome in patients with acute COVID-19-related arterial thrombosis in a large health maintenance organization (HMO). METHODS: A retrospective multicenter case review was performed from March 2020 to March 2021. Cases were identified through a questionnaire sent to vascular surgeons. Patient characteristics, imaging, treatment, and outcome were reviewed. Successful revascularization was defined as restoration of blood flow with viability of the end organ and absence of death within 30 days. Limb salvage was defined as prevention of major amputation (transtibial or transfemoral) and absence of death in 30 days. RESULTS: There were 37,845 patients admitted with COVID-19 complications during this time. Among this group, 26 patients (0.07%) had COVID-19-related arterial thrombosis. The mean age was 61.7 years (range, 33-82 years) with 20 men (77%) and 6 women (23%). Ethnic minorities comprised 25 of 26 cases (96%). Peripheral arterial disease (PAD) was present in 4 of 26 (15%), active smoking in 1 of 26 (3.8%), and diabetes in 19 of 26 (73%) cases. Most patients developed acute arterial ischemia in the outpatient setting, 20 of 26 (77%). Of the outpatients, 6 of 20 (30%) had asymptomatic COVID-19 and 14 of 20 (70%) had only mild upper respiratory symptoms. Distribution of ischemia was as follows: 23 patients had at least one lower extremity ischemia, one patient had cerebral and lower extremity, one had mesenteric and lower extremity, and one had upper extremity ischemia. Revascularization was attempted in 21 patients, of which 12 of 21 (57%) were successful. Limb salvage was successful in 13 of 26 (50%) patients. The overall mortality was 31% (8/26). CONCLUSIONS: Our experience in a large HMO revealed that the incidence of COVID-19-related arterial thrombosis was low. The actual incidence is likely to be higher since our method of case collection was incomplete. The majority of arterial thrombosis occurred in the outpatient setting in patients with asymptomatic or mild/moderate COVID-19 respiratory disease. Acute ischemia was the inciting factor for hospitalization in these cases. Acute lower extremity ischemia was the most common presentation, and limb salvage rate was lower than that expected when compared to ischemia related to PAD. Arterial thrombosis associated with COVID-19 portends a significantly higher mortality. Education of primary care providers is paramount to prevent delayed diagnosis as most patients initially developed ischemia in the outpatient setting and did not have a high cardiovascular risk profile.

Long-term follow-up of a racially and ethnically diverse population of men with localized prostate cancer who did not undergo initial active treatment.

BACKGROUND: There is limited research on the racial/ethnic differences in long-term outcomes for men with untreated, localized prostate cancer. METHODS: Men diagnosed with localized, Gleason ≤7 prostate cancer who were not treated within 1 year of diagnosis from 1997-2007 were identified. Cumulative incidence rates of the following events were calculated; treatment initiation, metastasis, death due to prostate cancer and all-cause mortality, accounting for competing risks. The Cox model of all-cause mortality and Fine-Gray sub distribution model to account for competing risks were used to test for racial/ethnic differences in outcomes adjusted for clinical factors. RESULTS: There were 3925 men in the study, 749 Hispanic, 2415 non-Hispanic white, 559 non-Hispanic African American, and 202 non-Hispanic Asian/Pacific Islander (API). Median follow-up was 9.3 years. At 19 years, overall cumulative incidence of treatment, metastasis, death due to prostate cancer, and all-cause mortality was 25.0%, 14.7%, 11.7%, and 67.8%, respectively. In adjusted models compared to non-Hispanic whites, African Americans had higher rates of treatment (HR = 1.39, 95% CI = 1.15-1.68); they had an increased risk of metastasis beyond 10 years after diagnosis (HR = 4.70, 95% CI = 2.30-9.61); API and Hispanic had lower rates of all-cause mortality (HR = 0.66, 95% CI = 0.52-0.84, and HR = 0.72, 95% CI = 0.62-0.85, respectively), and API had lower rates of prostate cancer mortality in the first 10 years after diagnosis (HR = 0.29, 95% CI = 0.09-0.90) and elevated risks beyond 10 years (HR = 5.41, 95% CI = 1.39-21.11). CONCLUSIONS: Significant risks of metastasis and prostate cancer mortality exist in untreated men beyond 10 years after diagnosis, but are not equally distributed among racial/ethnic groups.

Cost of Hospitalization Associated With Respiratory Syncytial Virus Infection Versus Influenza Infection in Hospitalized Older Adults.

Despite the severity of respiratory syncytial virus (RSV) disease in older adults, data on its costs are limited. We compared hospitalization costs for 2090 adults aged ≥ 60 years hospitalized with RSV or influenza by assigning direct health care costs. Hospitalization with RSV was associated with longer hospitalization and increased frequency of diagnosis-related groups for pulmonary complications, resulting in costs at least as great as those for influenza ($16 034 vs $15 163; 95% confidence interval for the difference, -$811 to $2547). Awareness of RSV disease burden in adults is needed to facilitate vaccination and treatment when they become available.

Validation of pediatric diabetes case identification approaches for diagnosed cases by using information in the electronic health records of a large integrated managed health care organization.

We explored the utility of different algorithms for diabetes case identification by using electronic health records. Inpatient and outpatient diagnosis codes, as well as data on laboratory results and dispensing of antidiabetic medications were extracted from electronic health records of Kaiser Permanente Southern California members who were less than 20 years of age in 2009. Diabetes cases were ascertained by using the SEARCH for Diabetes in Youth Study protocol and comprised the "gold standard." Sensitivity, specificity, positive and negative predictive values, accuracy, and the area under the receiver operating characteristic curve (AUC) were compared in 1,000 bootstrapped samples. Based on data from 792,992 youth, of whom 1,568 had diabetes (77.2%, type 1 diabetes; 22.2%, type 2 diabetes; 0.6%, other), case identification accuracy was highest in 75% of bootstrapped samples for those who had 1 or more outpatient diabetes diagnoses or 1 or more insulin prescriptions (sensitivity, 95.9%; positive predictive value, 95.5%; AUC, 97.9%) and in 25% of samples for those who had 2 or more outpatient diabetes diagnoses and 1 or more antidiabetic medications (sensitivity, 92.4%; positive predictive value, 98.4%; AUC, 96.2%). Having 1 or more outpatient type 1 diabetes diagnoses (International Classification of Diseases, Ninth Revision, Clinical Modification, code 250.x1 or 250.x3) had the highest accuracy (94.4%) and AUC (94.1%) for type 1 diabetes; the absence of type 1 diabetes diagnosis had the highest accuracy (93.8%) and AUC (93.6%) for identifying type 2 diabetes. Information in the electronic health records from managed health care organizations provides an efficient and cost-effective source of data for childhood diabetes surveillance.

The Kaiser Permanente experience with ultrasound-guided percutaneous endovascular abdominal aortic aneurysm repair.

BACKGROUND: This study was conducted to determine the effect of ultrasound (US)-guided percutaneous access for percutaneous endovascular abdominal aortic aneurysm repair (PEVAR) on conversion to open repair by femoral cutdown. We also sought to identify other risk factors associated with failure of percutaneous access and conversion to femoral cutdowns. METHODS: This is a single-center, retrospective review of 101 patients who underwent PEVAR between January 1, 2005 and July 31, 2009 (56 months). Risk factors that were evaluated for unsuccessful PEVAR included gender, age (≤65 and ≥66 years), US-guided percutaneous access, mechanical failure, abdominal aortic aneurysm size, and the following comorbidities: diabetes, hypertension, vessel calcification, and obesity (body mass index: ≥30 kg/m(2)). RESULTS: There were 10 (9.9%) conversions from percutaneous to femoral cutdown, yielding a success rate of 90.1% for a total percutaneous approach. Each converted patient had one groin converted, resulting in a cutdown rate per groin of 10/202 (5%). There were no 30-day mortalities. Univariate analysis showed that hypertension (P = 0.261), age ≥66 years (P = 0.741), current smoking history (P = 0.649), past smoking history (P = .093), diabetes (P = 0.908), vessel calcification (P = 0.8281), and body mass index ≥30 kg/m(2) (P = 0.052) did not significantly predict conversion to endovascular aortic aneurysm repair (EVAR). Mechanical failure significantly predicted conversion to cutdown EVAR (P = 0.0002), whereas US-guided percutaneous access influenced successful PEVAR (P = 0.030). Multivariate analysis showed that mechanical failure significantly predicted conversion to cutdown EVAR (P = 0.003) and US-guided percutaneous access influenced successful PEVAR (P = 0.040) after adjusting for smoking history and obesity. CONCLUSION: PEVAR is a viable option for aortic aneurysm repair that may be improved with US-guided percutaneous access by reducing the rate of femoral cutdowns.

Preventive care and health behaviors among overweight/obese men in HMOs.

OBJECTIVES: To examine potential weight-related disparities in receipt of preventive screening exams and to compare several quality indicators and health behaviors among overweight/obese men and healthy-weight men enrolled in 2 large managed care plans. STUDY DESIGN: Cross-sectional analysis nested within a diverse cohort of men participating in the California Men's Health Study (CMHS) (N = 80,771). METHODS: We extracted utilization of serum cholesterol, triglycerides, glucose, glycosylated hemoglobin, sigmoidoscopy exams, and prostatespecific antigen tests from health plan electronic sources. CMHS survey data provided information about diet and physical activity. Adjusted odds ratios and 95% confidence intervals were estimated to assess the association of screening exams and behaviors with categories of body mass index (BMI). RESULTS: Tests for cholesterol, glucose, and diabetes control increased across categories of BMI, while overweight and obese men were less likely to undergo screening exams for colorectal and prostate cancer. Smoking and alcohol consumption were less frequent among overweight/obese men; however, they reported diets higher in fat and lower in fruits and vegetables, and were much less likely to report moderate/vigorous activity and much more likely to be sedentary. CONCLUSIONS: Managed care organizations might reduce weight-related health risks and disparities in care with targeted efforts to promote cancer screenings, healthy diets, and physical activity among overweight and obese patients.

Correlates for human papillomavirus vaccination of adolescent girls and young women in a managed care organization.

The authors studied the characteristics of those who initiated the human papillomavirus (HPV) vaccine versus those who did not. Female members of Kaiser Permanente Southern California aged 9-26 years were identified and assessed for HPV vaccination between October 2006 and March 2008. Multivariable log-binomial regression was used to examine the association of the following factors with vaccine initiation: 1) demographics, 2) provider characteristics, 3) health care utilization, 4) women's health-related conditions, and 5) selected immune-related conditions. The study included 285,265 females. All analyses were stratified by 2 age groups: 9-17 years and 18-26 years. Black race (relative risk (RR)(9-17 years) = 0.93, RR(18-26 years) = 0.82), having a male primary care provider (RR(9-17 years) = 0.93, RR(18-26 years) = 0.84), and history of hospitalizations were associated with a lower likelihood of vaccine initiation. Higher neighborhood income level, physician office visits, and history of influenza vaccination (RR(9-17 years) = 1.20, RR(18-26 years) = 1.34) were associated with higher HPV vaccine uptake. Those with a history of sexually transmitted diseases were more likely and those with immune-related conditions were not less likely to initiate the HPV vaccine. These findings are helpful for interpreting the results of observational safety studies and providing insights for developing targeted HPV vaccination programs.

Correlates for completion of 3-dose regimen of HPV vaccine in female members of a managed care organization.

OBJECTIVE: To examine the rate and correlates of completion of the quadrivalent human papillomavirus vaccine (HPV4) 3-dose regimen because nonadherence to the regimen may adversely affect vaccine efficacy. PARTICIPANTS AND METHODS: Female members of Kaiser Permanente Southern California who were 9 to 26 years old, received the first dose of HPV4 between October 2006 and March 2007, and maintained health plan membership 12 months afterward were identified and followed up for regimen completion. We examined the following: (1) demographics/socioeconomic status, (2) primary care physician characteristics, (3) historical health service utilization, (4) women's health-related conditions, and (5) selected immune-related conditions for their association with completion in 2 age groups: 9 to 17 years and 18 to 26 years. Multivariable log-binomial regression was used to directly estimate relative risk (RR). RESULTS: Of the 34,193 females who initiated HPV4, the completion rate was 41.9% in the 9- to 17-year-old group and 47.1% in the 18- to 26-year-old group. Black race (RR, 0.70; 95% confidence interval [CI], 0.64-0.77) and lower neighborhood education level were associated with lower regimen completion. However, those in the 9- to 17-year-old group who were covered by the state-subsidized program Medi-Cal were more likely to complete the regimen (RR, 1.14; 95% CI, 1.07-1.22). Historical hospitalizations and emergency department visits (RR, 0.92; 95% CI, 0.87-0.96; and RR, 0.96; 95% CI, 0.94-0.98 per visit, respectively) and having a pediatrician were also predictors of noncompletion. A history of sexually transmitted diseases, abnormal Papanicolaou test results, and immune-related conditions (eg, asthma/infections) were not associated with regimen completion. CONCLUSION: These findings suggest that factors such as race or socioeconomic status should be considered when human papillomavirus vaccination programs are being designed and evaluated.