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To determine the risks associated with zoster vaccine when administered to patients taking immunosuppressant medications. Patients enrolled in 1 of 7 managed care organizations affiliated with the Vaccine Safety Datalink between January 1, 2006, and December 31, 2009, were eligible. The exposure of interest was zoster vaccination in patients with current or remote immunosuppressant drug use. The primary outcomes were disseminated varicella zoster virus (VZV) and herpes zoster in the 42 days after vaccination. Automated data were collected on immunosuppressant drugs and baseline medical conditions. A logistic regression model using inverse probability treatment weights was used to estimate the odds of developing VZV or herpes zoster. A total of 14,554 individuals had an immunosuppressant medication dispensed around the time of vaccination, including 4826 with current use and 9728 with remote use. Most patients were taking low-dose corticosteroids. No cases of disseminated VZV were found in the current or remote users. The risk of herpes zoster was elevated in the 42 days after vaccination in current vs remote users (adjusted odds ratio, 2.99; 95% CI, 1.58-5.70). We found that patients taking immunosuppressant medications at the time of vaccination had a modest increased risk of herpes zoster in the 42 days after vaccination. The development of herpes zoster within 42 days after vaccination suggests that this is more likely due to reactivation of latent zoster virus than dissemination of the vaccine-derived varicella virus. These findings support the current zoster vaccination guidelines.

Objective To characterise the relationship between simvastatin and risk of acute pancreatitis (AP). Design We conducted a retrospective cohort study (2006–2012) on data from an integrated healthcare system in southern California. Exposure to simvastatin was calculated from time of initial dispensation until 60 days following prescription termination. AP cases were defined by ICD-9 CM 577.0 and serum lipase≥3 times normal. Patients were censored at death, last follow-up, and onset of AP or end-of-study. Incidence rate of pancreatitis among simvastatin users was compared with the adult reference population. Robust Poisson regression was used to generate risk ratio (RR) estimates for simvastatin use adjusted for age, gender, race/ethnicity, gallstone-related disorders, hypertriglyceridaemia, smoking and alcohol dependence. Analysis was repeated for atorvastatin. Results Among 3 967 859 adult patients (median duration of follow-up of 3.4 years), 6399 developed an initial episode of AP. A total of 707 236 patients received simvastatin during the study period. Patients that received simvastatin were more likely to have gallstone-related disorders, alcohol dependence or hypertriglyceridaemia compared with the reference population. Nevertheless, risk of AP was significantly reduced with simvastatin use, crude incidence rate ratio 0.626 (95% CL 0.588, 0.668), p<0.0001. In multivariate analysis, simvastatin was independently associated with reduced risk of pancreatitis, adjusted RR 0.29 (95% CL 0.27, 0.31) after adjusting for age, gender, race/ethnicity, gallstone disorders, alcohol dependence, smoking and hypertriglyceridaemia. Similar results were noted with atorvastatin, adjusted RR 0.33(0.29, 0.38). Conclusions Use of simvastatin was independently associated with reduced risk of AP in this integrated healthcare setting. Similar findings for atorvastatin suggest a possible class effect.

COVID-19 vaccinations protect against severe illness and death, but associations with post-COVID conditions (PCC) are less clear. We aimed to evaluate the association between prior COVID-19 vaccination and new-onset PCC among individuals with SARS-CoV-2 infection across eight large healthcare systems in the United States. This retrospective matched cohort study used electronic health records (EHR) from patients with SARS-CoV-2 positive tests during March 2021-February 2022. Vaccinated and unvaccinated COVID-19 cases were matched on location, test date, severity of acute infection, age, and sex. Vaccination status was ascertained using EHR and integrated data on externally administered vaccines. Adjusted relative risks (RRs) were obtained from Poisson regression. PCC was defined as a new diagnosis in one of 13 PCC categories 30 days to 6 months following a positive SARS-CoV-2 test. The study included 161,531 vaccinated COVID-19 cases and 161,531 matched unvaccinated cases. Compared to unvaccinated cases, vaccinated cases had a similar or lower risk of all PCC categories except mental health disorders (RR: 1.06, 95% CI: 1.02–1.10). Vaccination was associated with ≥10% lower risk of sensory (RR: 0.90, 0.86–0.95), circulatory (RR: 0.88, 0.83–0.94), blood and hematologic (RR: 0.79, 0.71–0.89), skin and subcutaneous (RR: 0.69, 0.66–0.72), and non-specific COVID-19 related disorders (RR: 0.53, 0.51–0.56). In general, associations were stronger at younger ages but mostly persisted regardless of SARS-CoV-2 variant period, receipt of ≥3 vs. 1–2 vaccine doses, or time since vaccination. Pre-infection vaccination was associated with reduced risk of several PCC outcomes and hence may decrease the long-term consequences of COVID-19. The impact of COVID-19 vaccination on post-COVID conditions is not well understood. Here, the authors use electronic health record data from a network of eight integrated healthcare systems in the United States to compare rates of post-COVID conditions in those with and without vaccination.

Background Atrial fibrillation (AF) patients are routinely prescribed medications to prevent and treat complications, including those from common co-occurring comorbidities. However, adherence to such medications may be suboptimal. Therefore, we sought to identify risk factors for general medication non-adherence in a population of patients with atrial fibrillation. Methods Data were collected from a large, ethnically-diverse cohort of Kaiser Permanente Northern and Southern California adult members with incident diagnosed AF between January 1, 2006 and June 30, 2009. Self-reported questionnaires were completed between May 1, 2010 and September 30, 2010, assessing patient socio-demographics, health behaviors, health status, medical history and medication adherence. Medication adherence was assessed using a previously validated 3-item questionnaire. Medication non-adherence was defined as either taking medication(s) as the doctor prescribed 75% of the time or less, or forgetting or choosing to skip one or more medication(s) once per week or more. Electronic health records were used to obtain additional data on medical history. Multivariable logistic regression analyses examined the associations between patient characteristics and self-reported general medication adherence among patients with complete questionnaire data. Results Among 12,159 patients with complete questionnaire data, 6.3% ( n  = 771) reported medication non-adherence. Minority race/ethnicity versus non-Hispanic white, not married/with partner versus married/with partner, physical inactivity versus physically active, alcohol use versus no alcohol use, any days of self-reported poor physical health, mental health and/or sleep quality in the past 30 days versus 0 days, memory decline versus no memory decline, inadequate versus adequate health literacy, low-dose aspirin use versus no low-dose aspirin use, and diabetes mellitus were associated with higher adjusted odds of non-adherence, whereas, ages 65–84 years versus < 65 years of age, a Charlson Comorbidity Index score ≥ 3 versus 0, and hypertension were associated with lower adjusted odds of non-adherence. Conclusions Several potentially preventable and/or modifiable risk factors related to medication non-adherence and a few non-modifiable risk factors were identified. These risk factors should be considered when assessing medication adherence among patients diagnosed with AF.

Pulmonary nodules are common incidental findings, but information about their incidence in the era of computed tomography (CT) is lacking. To examine recent trends in pulmonary nodule identification. We used electronic health records and natural language processing to identify members of an integrated health system who had nodules measuring 4 to 30 mm. We calculated rates of chest CT imaging, nodule identification, and receipt of a new lung cancer diagnosis within 2 years of nodule identification, and standardized rates by age and sex to estimate the frequency of nodule identification in the U.S. population in 2010. Between 2006 and 2012, more than 200,000 adult members underwent 415,581 chest CT examinations. The annual frequency of chest CT imaging increased from 1.3 to 1.9% for all adult members, whereas the frequency of nodule identification increased from 24 to 31% for all scans performed. The annual rate of chest CT increased from 15.4 to 20.7 per 1,000 person-years, and the rate of nodule identification increased from 3.9 to 6.6 per 1,000 person-years, whereas the rate of a new lung cancer diagnosis remained stable. By extrapolation, more than 4.8 million Americans underwent at least one chest CT scan and 1.57 million had a nodule identified, including 63,000 who received a new lung cancer diagnosis within 2 years. Incidental pulmonary nodules are an increasingly common consequence of routine medical care, with an incidence that is much greater than recognized previously. More frequent nodule identification has not been accompanied by increases in the diagnosis of cancerous nodules.

•No significant increased risk of pre-specified adverse events following PCV13.•An increased risk for encephalopathy was not confirmed by medical record review.•The association between PCV13 and Kawasaki disease needs further investigation. Although no increased risk was detected for serious adverse events in the prelicensure trials for the 13-valent pneumococcal vaccine, Prevnar 13® (PCV13), continued monitoring of rare but serious adverse events is necessary. A surveillance system using cohort study design was set up to monitor safety of PCV13 immediately after it was included in the childhood immunization program in the United States. The exposed population included children of 1 month to 2 years old who received PCV13 from April, 2010 to January, 2012 from the eight managed care organizations participating in the Vaccine Safety Datalink Project in the United States. The historical unexposed population was children of the same age who received the 7-valent pneumococcal conjugate vaccine Prevnar 7® (PCV7) in 2007 (or 2005 depending on the outcome of interest) to 2009. The risk of pre-specified adverse events in the risk window following PCV13 was repeatedly compared to that in the historical comparison group. The number of doses included in the study was 599,229. No increased risk was found for febrile seizures, urticaria or angioneurotic edema, asthma, thrombocytopenia, or anaphylaxis. An increased risk for encephalopathy was not confirmed following the medical record review. The relative risk for Kawasaki disease in 0–28 days following vaccination was 1.94 (95% confidence interval: 0.79–4.86), comparing PCV13 to PCV7. Comparing to PCV7 vaccine, we identified no significant increased risk of pre-specified adverse events in the Vaccine Safety Datalink study cohort. The possible association between PCV13 and Kawasaki disease may deserve further investigation.

Shoulder injury related to vaccine administration (SIRVA) accounts for more than half of all claims received by the National Vaccine Injury Compensation Program. However, due to the difficulty of finding SIRVA cases in large health care databases, population-based studies are scarce. The goal of the research was to develop a natural language processing (NLP) method to identify SIRVA cases from clinical notes. We conducted the study among members of a large integrated health care organization who were vaccinated between April 1, 2016, and December 31, 2017, and had subsequent diagnosis codes indicative of shoulder injury. Based on a training data set with a chart review reference standard of 164 cases, we developed an NLP algorithm to extract shoulder disorder information, including prior vaccination, anatomic location, temporality and causality. The algorithm identified 3 groups of positive SIRVA cases (definite, probable, and possible) based on the strength of evidence. We compared NLP results to a chart review reference standard of 100 vaccinated cases. We then applied the final automated NLP algorithm to a broader cohort of vaccinated persons with a shoulder injury diagnosis code and performed manual chart confirmation on a random sample of NLP-identified definite cases and all NLP-identified probable and possible cases. In the validation sample, the NLP algorithm had 100% accuracy for identifying 4 SIRVA cases and 96 cases without SIRVA. In the broader cohort of 53,585 vaccinations, the NLP algorithm identified 291 definite, 124 probable, and 52 possible SIRVA cases. The chart-confirmation rates for these groups were 95.5% (278/291), 67.7% (84/124), and 17.3% (9/52), respectively. The algorithm performed with high sensitivity and reasonable specificity in identifying positive SIRVA cases. The NLP algorithm can potentially be used in future population-based studies to identify this rare adverse event, avoiding labor-intensive chart review validation.

Background: Diabetic nephropathy is the leading cause of end-stage renal disease in the USA, yet most patients with type 2 diabetes mellitus are not formally evaluated with a renal biopsy. Our aim was to evaluate the prevalence of nondiabetic renal disease (NDRD) in patients with type 2 diabetes mellitus to determine common clinical indicators suggestive of NDRD. Methods: A retrospective analysis was performed on biopsy reports of patients who had undergone native renal biopsy between January 1, 1995, and December 31, 2005. Results: After exclusion of 57 patients, 233 patients with DM2 were included in our analysis. Mean age at the time of biopsy was 58.1 ± 13.7 years, and 53.0% of the study population were male. There were 124 cases (53.2%) with a pathologic diagnosis of NDRD, 64 (27.5%) with pure diabetic glomerulosclerosis (DGS) and 45 (19.3%) with concurrent NDRD and DGS (CD). Patients with NDRD tended to be younger than those with DGS and had significantly less associated diabetic retinopathy. Focal segmental glomerulosclerosis was the most common lesion found in patients with NDRD and accounted for 21.0% of all NDRD, followed by minimal-change disease (15.3%). IgA nephropathy (15.6%) and membranous glomerulonephritis (13.3%) were the most prevalent lesions found in patients with CD. Conclusions: The high prevalence of NDRD found in our population underscores the need for clinicians to consider renal biopsy in diabetic patients with an atypical clinical course, since additional disease-specific therapies may be helpful for this subset of the population.

Background Bone mineral density is one parameter used to decide whether patients with primary hyperparathyroidism (PHPT) should undergo parathyroidectomy. However, the influence of bone mineral density and parathyroidectomy on subsequent fracture risk is unclear. Methods The authors conducted a retrospective cohort study of patients with PHPT based on administrative discharge abstract data. The dual energy x-ray absorptiometry (DEXA) scan T-scores at the femur were collected by chart review, and 10-year fracture-free survival (FFS) was the main outcome measured. Results A total of 533 patients were identified, most of them ≥ 50 years old (89%) and female (87%). Seventeen percent of the patients were black. Mean initial calcium, parathormone, and creatinine levels were 11.1 mg/dl, 116 pg/ml, and 0.9 mg/dl, respectively. Parathyroidectomy was performed in 159 (30%) patients, and 374 (70%) were observed. The 10-year FFS after PHPT diagnosis was 94% in patients treated with parathyroidectomy and 81% in those observed ( p  = 0.006). Compared to observation, parathyroidectomy improved the 10-year FFS by 9.1% ( p  = 0.99), 12% ( p  = 0.92), and 12% ( p  = 0.02) in patients with normal bones (T-score ≥ −1.0), osteopenia (T-score ≤ −1.0, ≥ −2.5), and osteoporosis (T-score < −2.5), respectively. On multivariate analysis, parathyroidectomy was independently associated with decreased fracture risk (HR = 0.41; 95%CI 0.18, 0.93), whereas non-black race (HR = 2.94; 95%CI 1.04, 8.30) and T-score < −2.5 (HR = 2.29; 95%CI 1.08, 4.88) remained independently associated with increased fracture risk. Conclusions Parathyroidectomy decreases the risk of fracture in patients with normal, osteopenic, and osteoporotic bones. The largest impact from parathyroidectomy is in patients with osteoporosis. The highest risk of fracture is in non-blacks and in patients with osteoporosis.

In patients with new-onset heart failure (HF), coronary artery disease (CAD) testing remains underutilized. Whether widespread CAD testing in patients with new-onset HF leads to improved outcomes remains to be determined. We sought to examine whether CAD testing, and its timing, among patients hospitalized with new-onset HF with reduced ejection fraction (HFrEF), is associated with improved outcomes. Retrospective cohort study. Adult (≥ 18 years) non-pregnant patients with new-onset HFrEF hospitalized within one of 15 Kaiser Permanente Southern California medical centers between 2016 and 2021. Key exclusion criteria included history of heart transplant, hospice, and a do-not-resuscitate order. Primary outcome was a composite of HF readmission or all-cause mortality through end of follow-up on 12/31/2022. Among 2729 patients hospitalized with new-onset HFrEF, 1487 (54.5%) received CAD testing. The median age was 66 (56-76) years old, 1722 (63.1%) were male, and 1074 (39.4%) were White. After a median of 1.8 (0.6-3.4) years, the testing group had a reduced risk of HF readmission or all-cause mortality (aHR [95%CI], 0.71 [0.63-0.79]). These results were consistent across subgroups by history of atrial fibrillation, diabetes, renal disease, myocardial infarction, and elevated troponin during hospitalization. In a secondary analysis where CAD testing was further divided to early (received testing before discharge) and late testing (up to 90 days after discharge), there was no difference in late vs early testing (0.97 [0.81-1.16]). In a contemporary and diverse cohort of patients hospitalized with new-onset HFrEF, CAD testing within 90 days of hospitalization was associated with a lower risk of HF readmission or all-cause mortality. Testing within 90 days after discharge was not associated with worse outcomes.