Validation of a claims-based algorithm for identifying non-infectious pneumonitis in patients diagnosed with lung cancer.

PURPOSE: Non-infectious pneumonitis (NIP) is a common complication of treatments for lung cancer. We know of no existing validated algorithm for identifying NIP in claims databases, limiting our ability to understand the morbidity and mortality of this toxicity in real-world data. METHODS: Electronic health records (EHR), cancer registry, and administrative data from a National Cancer Institute-designated comprehensive cancer center were queried for patients diagnosed with lung cancer between 10/01/2015-12/31/2020. Health insurance claims were searched for ICD-10-CM codes that indicate an inpatient or outpatient diagnosis with possible NIP. A 20-code (Algorithm A) and 11-code (Algorithm B) algorithm were tested with and without requiring prescription with corticosteroids. Cases with a diagnosis of possible NIP in the 6 months before their first lung cancer diagnosis were excluded. The algorithms were validated by reviewing the EHR. The positive predictive value (PPV) for each algorithm was computed with 95% confidence intervals (CI). RESULTS: Seventy patients with lung cancer had a diagnosis code compatible with NIP: 36 (51.4%) inpatients and 34 (48.6%) outpatients. The PPV of Algorithm A was 77.1% (95% CI: 65.6-86.3). The PPV of Algorithm B was 86.9% (95% CI: 75.8-94.2). Requiring a documented prescription for a systemic corticosteroid improved the PPV of both Algorithm A and Algorithm B: 92.5% (95% CI: 79.6-98.4) and 100.0% (95% CI: 90.0-100.0), respectively. CONCLUSIONS: This study validated ICD-10-CM and prescription-claims-based definitions of NIP in lung cancer patients. All algorithms have at least reasonable performance. Enriching the algorithm with corticosteroid prescription records results in excellent performance.

Children with lower respiratory tract infections and serum 25-hydroxyvitamin D3 levels: A case-control study.

BACKGROUND: Pneumonia is the leading cause of death in children under age of 5 years worldwide. The role of vitamin D in respiratory infections including pneumonia is unclear; therefore, we aimed to determine if children with lower respiratory tract infections had low serum 25-hydroxyvitamin D3 . METHODS: We performed a case-control study of children ages 3-60 months from the Guatemala City metropolitan area, hospitalized with community-acquired pneumonia between September and December 2012. Controls were selected from the well-baby/care immunization clinics serving the population from which cases emerged. We analyzed serum 25-hydroxyvitamin D3 levels and conducted parental interviews to assess subject age, sex, race, feeding type, vitamin D supplementation, frequency of sun exposure, and maternal education. Height and weight were ascertained from medical records. Complete information was available for 70 (83%) of 84 eligible cases and 68 (60%) of 113 eligible controls. RESULTS: The median (IQR) serum 25-hydroxyvitamin D3 concentration for cases was 23.2 ng/ml (14.4-29.9) compared to 27.5 ng/ml (21.4-32.3) in controls (P = 0.006). Multiple regression analysis using an a priori cut-point for vitamin D of <20 ng/ml showed that children with lower respiratory tract infections were more likely to have low 25-hydroxyvitamin D3 levels than controls (adjusted odds ratio 2.4, 95% confidence interval 1.1-5.2, P = 0.02). CONCLUSIONS: Children with lower respiratory tract infections in Guatemala had low 25-hydroxyvitamin D3 levels. Pediatr Pulmonol. 2016;51:1080-1087. © 2016 Wiley Periodicals, Inc.

Population-representative incidence of drug-induced acute liver failure based on an analysis of an integrated health care system.

BACKGROUND & AIMS: Medications are a major cause of acute liver failure (ALF) in the United States, but no population-based studies have evaluated the incidence of ALF from drug-induced liver injury. We aimed to determine the incidence and outcomes of drug-induced ALF in an integrated health care system that approximates a population-based cohort. METHODS: We performed a retrospective cohort study using data from the Kaiser Permanente Northern California (KPNC) health care system between January 1, 2004, and December 31, 2010. We included all KPNC members age 18 years and older with 6 months or more of membership and hospitalization for potential ALF. The primary outcome was drug-induced ALF (defined as coagulopathy and hepatic encephalopathy without underlying chronic liver disease), determined by hepatologists who reviewed medical records of all KPNC members with inpatient diagnostic and laboratory criteria suggesting potential ALF. RESULTS: Among 5,484,224 KPNC members between 2004 and 2010, 669 had inpatient diagnostic and laboratory criteria indicating potential ALF. After medical record review, 62 (9.3%) were categorized as having definite or possible ALF, and 32 (51.6%) had a drug-induced etiology (27 definite, 5 possible). Acetaminophen was implicated in 18 events (56.3%), dietary/herbal supplements in 6 events (18.8%), antimicrobials in 2 events (6.3%), and miscellaneous medications in 6 events (18.8%). One patient with acetaminophen-induced ALF died (5.6%; 0.06 events/1,000,000 person-years) compared with 3 patients with non-acetaminophen-induced ALF (21.4%; 0.18/1,000,000 person-years). Overall, 6 patients (18.8%) underwent liver transplantation, and 22 patients (68.8%) were discharged without transplantation. The incidence rates of any definite drug-induced ALF and acetaminophen-induced ALF were 1.61 events/1,000,000 person-years (95% confidence interval, 1.06-2.35) and 1.02 events/1,000,000 person-years (95% confidence interval, 0.59-1.63), respectively. CONCLUSIONS: Drug-induced ALF is uncommon, but over-the-counter products and dietary/herbal supplements are its most common causes.

Vitamin and mineral use and risk of prostate cancer: the case-control surveillance study.

BACKGROUND: Many studies have evaluated the association between vitamin and mineral supplement use and the risk of prostate cancer, with inconclusive results. METHODS: The authors examined the relation of use of multivitamins as well as several single vitamin and mineral supplements to the risk of prostate cancer risk among 1,706 prostate cancer cases and 2,404 matched controls using data from the hospital-based case-control surveillance study conducted in the United States. Odds ratios (OR) and 95% confidence intervals (CI) for risk of prostate cancer were estimated using conditional logistic regression model. RESULTS: For use of multivitamins that did not contain zinc, the multivariable odds ratios of prostate cancer were 0.6 for 1-4 years, 0.8 for 5-9 years, and 1.2 for 10 years or more, respectively (p for trend = 0.70). Men who used zinc for ten years or more, either in a multivitamin or as a supplement, had an approximately two-fold (OR = 1.9, 95% CI: 1.0, 3.6) increased risk of prostate cancer. Vitamin E, beta-carotene, folate, and selenium use were not significantly associated with increased risk of prostate cancer. CONCLUSION: The finding that long-term zinc intake from multivitamins or single supplements was associated with a doubling in risk of prostate cancer adds to the growing evidence for an unfavorable effect of zinc on prostate cancer carcinogenesis.

A retrospective case-control study of the use of hormone-related supplements and association with breast cancer.

Hormone-related supplements (HRS), many of which contain phytoestrogens, are widely used to manage menopausal symptoms, yet their relationship with breast cancer risk has generally not been evaluated. We evaluated whether use of HRS was associated with breast cancer risk, using a population-based case-control study in 3 counties of the Philadelphia metropolitan area consisting of 949 breast cancer cases and 1,524 controls. Use of HRS varied significantly by race, with African American women being more likely than European American women to use any herbal preparation (19.2% vs. 14.7%, p=0.003) as well as specific preparations including black cohosh (5.4% vs. 2.0%, p=0.003), ginseng (12.5% vs. 7.9%, p<0.001) and red clover (4.7% vs. 0.6%, p<0.001). Use of black cohosh had a significant breast cancer protective effect (adjusted odds ratio 0.39, 95% CI: 0.22-0.70). This association was similar among women who reported use of either black cohosh or Remifemin (an herbal preparation derived from black cohosh; adjusted odds ratio 0.47, 95% CI: 0.27-0.82). The literature reports that black cohosh may be effective in treating menopausal symptoms, and has antiestrogenic, antiproliferative and antioxidant properties. Additional confirmatory studies are required to determine whether black cohosh could be used to prevent breast cancer.

Risk of serious upper gastrointestinal toxicity with over-the-counter nonaspirin nonsteroidal anti-inflammatory drugs.

BACKGROUND & AIMS: Use of prescription nonaspirin nonsteroidal anti-inflammatory drugs (NANSAIDs) increases the risk of serious upper gastrointestinal toxicity. Less is known about over-the-counter (OTC) NANSAIDs, which are typically used at lower doses and for shorter durations. This study assessed the risk of toxicity with OTC NANSAIDs. METHODS: A total of 359 case subjects hospitalized for upper gastrointestinal bleeding, perforation, or benign gastric outlet obstruction were recruited from 28 hospitals. A total of 1889 control subjects were recruited by random digit dialing from the same region. Data on medication use were collected via structured telephone interview. RESULTS: Use of OTC NANSAIDs on > or = 4 days during the most recent week had an adjusted odds ratio (OR) of 1.83 (95% confidence interval [CI], 1.14-2.95). Use of high-dose OTC NANSAIDs during the index week had an adjusted OR of 5.21 (95% CI, 2.32-11.69). In contrast, use of OTC NANSAIDs <4 times during the index week (adjusted OR, 0.67; 95% CI, 0.43-1.06) and use of very low doses of prescription or OTC NANSAIDs during the index week (adjusted OR, 0.74; 95% CI, 0.49-1.12) were not significantly associated with an increased risk of serious gastrointestinal toxicity. We did not observe a significant difference between the risk of toxicity with OTC naproxen versus OTC ibuprofen (adjusted OR, 0.84; 95% CI, 0.26-2.70). CONCLUSIONS: Use of OTC NANSAIDs at recommended doses has a relatively good safety profile compared with prescription NANSAIDs. However, use of high-dose OTC NANSAIDs (comparable to a prescription dose) is associated with serious gastrointestinal toxicity.

Patterns of complementary and alternative medicine use in a population of pediatric patients with inflammatory bowel disease.

Complementary and alternative medicine use is prominent in the United States. The use of complementary and alternative therapies appears to be common in patients with inflammatory bowel disease, but few studies have been completed in children. We sought to examine the extent that children with inflammatory bowel disease in the Greater Philadelphia area (Philadelphia County and the surrounding counties in Delaware, New Jersey, and Pennsylvania) use alternative therapies. We paid particular attention to the specific types of therapies used and whether certain demographic and disease associated factors influence the degree of usage. In this study, we questioned the families of all children diagnosed with inflammatory bowel disease, aged 6 to 16 years and living within Philadelphia and its surrounding counties, who were followed at 1 of the 2 academic pediatric gastroenterology programs that served the area. More than 80% of surveys were returned. Fifty-one percent (95% C.I. 45% to 56%) of patients surveyed reported some form of alternative medicine use within the previous year. Univariate analysis revealed increased use among patients who had Crohn disease, who used the Internet for research on their disease, who reported poor quality of life and had increased school absences in the past year. Therapies associated with alternative medicine use included biological and immunomodulatory therapy. Regression analysis revealed positive associations between use of alternative therapies and expenditure on nonprescription treatments, poor quality of life, Internet research, and the need for calorie supplementation, whereas there was a negative association with history of prior surgery for inflammatory bowel disease.

Prior antimicrobial drug exposure: a risk factor for trimethoprim-sulfamethoxazole-resistant urinary tract infections.

OBJECTIVES: Antimicrobial drug use is believed to be an important risk factor for the emerging problem of antimicrobial drug resistance, yet strong evidence for the causal relationship in community settings has been limited. Detailed analysis of this risk factor at the level of the individual patient has been hampered by limited availability of drug exposure data among patients with outpatient infections. We used a novel data system to identify patterns of individual antimicrobial drug exposures associated with trimethoprim-sulfamethoxazole-resistant urinary tract infections (UTIs). MATERIALS AND METHODS: This was a retrospective case-control study. Subjects were veterans with Gram-negative UTIs seen at the Philadelphia VA Medical Center from 1 July 1996 to 31 December 1999. Subjects were linked to a national VA outpatient pharmacy database. Cases and controls were identified based on the results of trimethoprim-sulfamethoxazole susceptibility testing. RESULTS: Three hundred and ninety-three veterans with UTIs could be linked to electronic pharmacy records. The overall rate of trimethoprim-sulfamethoxazole drug resistance was 13%, without significant annual variation. Antimicrobial drug exposure within 6 months was strongly associated with the probability of a trimethoprim-sulfamethoxazole-resistant infection (OR = 4.1, 95% CI 2.2-7.5). This association extended to exposure to other antimicrobial drugs in addition to trimethoprim-sulfamethoxazole and the overall association displayed a dose-response relationship in terms of the number of prior drug exposures. CONCLUSIONS: Prior antimicrobial drug exposure is a strong risk factor for infection with trimethoprim-sulfamethoxazole-resistant Gram-negative bacteria among patients with UTIs.