Blood stored in EDTA tubes provides accurate peanut basophil activation test results for 48 hours.

BACKGROUND: The peanut basophil activation test (BAT) has demonstrated excellent diagnostic accuracy with heparinized blood, but its clinical utility is limited by the short stability of samples stored in this anticoagulant. OBJECTIVE: Using EDTA anticoagulated blood, these investigations determined if Peanut BAT sample stability can be extended to 2 days, the minimum stability requirement for diagnostic tests currently offered through American reference laboratories. METHODS: Peanut non-allergic control (NAC), peanut IgE sensitized (PS), and peanut allergic (PA) children aged 6 months through 17 years were recruited from members of Kaiser Permanente Southern California. EDTA anti-coagulated blood samples were collected from participants, shipped to a centralized laboratory, and stored at 4oC for peanut BAT testing 1 and 2 days later. RESULTS: Peanut BAT results for 23 unblinded participants were used to establish sample rejection and interpretation criteria that were subsequently validated in a prospective double-blind study involving 112 additional children (39-NAC, 36-PS, 37-PA). Of 105 blinded blood samples tested on each study day, 88 (84%) day-1 and 90 (86%) day-2 peanut BAT results were considered interpretable, with diagnostic accuracies of 95.5% and 94.4%, respectively. Moreover, all interpretable PA results were considered positive (100% sensitivity). CONCLUSION: Using EDTA anti-coagulated blood samples collected remotely, 1 and 2 days before testing, study results highlight the favorable diagnostic performance characteristics of the peanut BAT and provide further evidence that the test could be readily operationalized for clinical use by interested commercial reference laboratories.

Effect of omalizumab on outcomes in patients with aspirin-exacerbated respiratory disease.

Background: The current treatment for patients with aspirin-exacerbated respiratory disease (AERD) who have uncontrolled asthma or chronic rhinosinusitis is aspirin desensitization. For patients who are unable to undergo or do not benefit from aspirin desensitization, treatment with biologics is an option, although efficacy data for AERD is scarce. Objective: We reported a series of patients with AERD who were started on omalizumab and measured the outcomes to assess improvement. Methods: Adult patients with AERD who were initiated on omalizumab from January 2007 to January 2018 were included. We compared outcomes 6-12 months before initiating biologic therapy and during the last 6-12 months while they were on biologic therapy. Our study investigated the number of oral steroid courses, short-acting beta-agonists (SABA), antibiotics for sinusitis or pneumonia, emergency department visits, hospitalizations, pulmonary function tests, and changes in controller medications. Results: Twenty-nine patients were placed on omalizumab. Sixty-two percent demonstrated a reduction in the number of steroid courses (p = 0.0014) and number of SABA canisters used (p = 0.0005) during their last 12 months while on omalizumab. Eighty-six percent of the patients with AERD and on omalizumab demonstrated either a decrease in the number of steroid courses or number of SABA canisters used in the last year of the study. The patients with AERD and with concomitant immunoglobulin E (IgE) mediated respiratory disease showed a statistically significant reduction in the number of steroid courses and number of SABA canisters used while on omalizumab for 1 year (p = 0.002 and p = 0.005, respectively), whereas those without concomitant IgE-mediated respiratory disease did not have a substantial reduction in steroids or SABA canisters used. Conclusion: Our case series reported that omalizumab could effectively be used as an adjunct treatment for AERD, but additional larger and longitudinal studies are needed to corroborate these findings.

Angioedema deaths in the United States, 1979-2010.

BACKGROUND: Hospital admission data indicate that the angioedema incidence has increased during the past several decades. Little is known about mortality trends. OBJECTIVES: To count the number of deaths associated with angioedema in the United States, investigate correlations with age, sex, race, and other contributory causes, and analyze trends from 1979 to 2010. METHODS: All US death certificates in which angioedema was listed as an underlying or contributing cause of death during 1979 to 2010 were analyzed. Age-adjusted mortality rates were analyzed by age, sex, and race. Other conditions designated as the underlying cause of death were investigated. RESULTS: From 1979 to 2010, there were 5,758 deaths in which angioedema was listed as a contributing cause. The age-adjusted death rate for hereditary angioedema decreased from 0.28 (95% confidence interval [CI] 0.25-0.32) to 0.06 (95% CI 0.05-0.08) per million persons per year. Conversely, mortality for angioedema increased from 0.24 (95% CI 0.21-0.27) to 0.34 (95% CI 0.31-0.37) per million. Blacks constituted 55% of angioedema deaths that were associated with use of angiotensin-converting enzyme inhibitors. On death certificates that listed hereditary angioedema as the underlying cause of death, cancer (frequently lymphoma or leukemia) was the second most commonly listed cause. CONCLUSION: Angioedema-associated deaths were very rare from 1979 to 2010. Hereditary angioedema deaths became even more so, whereas nonhereditary angioedema deaths increased. Risks associated with angiotensin-converting enzyme inhibitors were higher in blacks. Lack of specific coding for acquired angioedema most likely explains the observed association between cancer and hereditary angioedema. In the future, more granular coding systems may help distinguish hereditary from acquired angioedema.

Patients' Willingness to Accept Social Needs Navigation After In-Person versus Remote Screening.

BACKGROUND: Social needs screening and referral interventions are increasingly common in health care settings. Although remote screening offers a potentially more practical alternative to traditional in-person screening, there is concern that screening patients remotely could adversely affect patient engagement, including interest in accepting social needs navigation. METHODS: We conducted a cross-sectional study using a multivariable logistic regression analysis and data from the Accountable Health Communities (AHC) model in Oregon. Participants were Medicare and Medicaid beneficiaries in the AHC model from October 2018 through December 2020. The outcome variable was patients' willingness to accept social needs navigation assistance. We included an interaction term (total number of social needs + screening mode) to test whether in-person versus remote screening was an effect modifier. RESULTS: The study included participants who screened positive for ≥1 social need(s); 43% were screened in person and 57% remotely. Overall, 71% of participants were willing to accept help with social needs. Neither screening mode nor interaction term were significantly associated with willingness to accept navigation assistance. CONCLUSIONS: Among patients presenting with similar numbers of social needs, results indicate that type of screening mode may not adversely affect patients' willingness to accept health care-based navigation for social needs.

"It Made Me Feel like Things Are Starting to Change in Society:" A Qualitative Study to Foster Positive Patient Experiences during Phone-Based Social Needs Interventions.

Many healthcare organizations are screening patients for health-related social needs (HRSN) to improve healthcare quality and outcomes. Due to both the COVID-19 pandemic and limited time during clinical visits, much of this screening is now happening by phone. To promote healing and avoid harm, it is vital to understand patient experiences and recommendations regarding these activities. We conducted a pragmatic qualitative study with patients who had participated in a HRSN intervention. We applied maximum variation sampling, completed recruitment and interviews by phone, and carried out an inductive reflexive thematic analysis. From August to November 2021 we interviewed 34 patients, developed 6 themes, and used these themes to create a framework for generating positive patient experiences during phone-based HRSN interventions. First, we found patients were likely to have initial skepticism or reservations about the intervention. Second, we identified 4 positive intervention components regarding patient experience: transparency and respect for patient autonomy; kind demeanor; genuine intention to help; and attentiveness and responsiveness to patients' situations. Finally, we found patients could be left with feelings of appreciation or hope, regardless of whether they connected with HRSN resources. Healthcare organizations can incorporate our framework into trainings for team members carrying out phone-based HRSN interventions.

The Organizational Risks Of Cross-Sector Partnerships: A Comparison Of Health And Human Services Perspectives.

What factors do health and human services leaders assess when considering collaborative opportunities, and what do they worry about? How organizational decision makers perceive risk can influence the success or failure of cross-sector partnerships designed to address social determinants of health. This article captures insights from leaders at twenty-two health and human services organizations in Oregon who were involved in the Centers for Medicare and Medicaid Services' Accountable Health Communities initiative in 2019 and familiar with efforts by their local health systems to identify people with unmet social needs and refer them to community programs. We explore perspectives on the risks and benefits associated with this cross-sector work. Leaders from both sectors perceived collaboration risks to reputation, sustainability, and compliance with regulatory or funder requirements. They also had difficulty gauging the reliability of partners that were sometimes perceived as competitive or coercive. Risk perceptions were manifested differently across sectors, which has implications for the design, implementation, and governance of cross-sector initiatives.

Health policy roundtable--view from the state legislature: translating research into policy.

This roundtable examines the role of health services research from the perspective of the state legislature. Four research and policy experts-each of whom is a current or former legislator-explore how research can be translated effectively into state health policy, and how researchers and legislators can communicate clearly with one another and engage in productive collaborations.

Utility of an intervention to detect depression in primary care.

OBJECTIVE: To determine whether a 3-part intervention consisting of raising physicians` awareness of depression, mass depression screening using a 2-item version of the Prime MD Questionnaire, and communicating the results of the screening to the physician, will improve detection and treatment of depression in a primary care setting. METHODS: The study took place in Hilsboro, Oregon between July 1, 2001 and September 30, 2001. We distributed educational materials to the primary care physicians 2 months before screening patients. Over a 3 month period, 3431 consecutive patients who visited Tuality Health Care primary care clinics were screened using a 2-item version of the Prime MD depression-screening questionnaire. The primary care physicians conducted further assessment for certain patients to determine if any screened patient was depressed. We included all adult patients who visited Tuality Health Care primary care clinics between July 1, 2001 and September 30, 2001 in the study. We excluded patients attending the clinic for an emergency and children below 15 years of age. RESULTS: Out of 3431 subjects initially screened, we included 3290 subjects (96%) in the analysis. Of these, 360 subjects (10.9%) were already being treated for depression. The median age of the population was 48.5, 63.6% were females, and 36.4% were males. Physicians were more likely to conduct further assessment for depression when the screening result was positive (odds ratio [OR] = 119.13, 95% confidence interval [CI]: 81.017-175.17). They were also more likely to make a new diagnosis of depression when the screening result was positive (OR = 117.245, 95% CI: 51.67-266.02). CONCLUSION: The intervention is a useful depression screening effort in primary care. We should also consider implementation in other primary care settings.

Effects of a prior-authorization policy for celecoxib on medical service and prescription drug use in a managed care Medicaid population.

BACKGROUND: Prior authorization (PA) is a poorly studied but commonly employed policy used by health care payers to manage the rising costs of pharmacy benefits. OBJECTIVE: The aim of this study was to evaluate the intended and unintended effects of a PA policy for celecoxib on pharmacy and medical-service utilization in a Medicaid managed-care organization. METHODS: This was a retrospective, interrupted time-series analysis of 22 monthly health-related utilization rates from January 1, 1999, to October 31, 2000. All Medicaid claims for CareOregon (a managed-care organization) and a fee-for-service program were reviewed. A model was constructed to evaluate changes in utilization of therapeutically related drug classes (eg, conventional nonsteroidal anti-inflammatory drugs [NSAIDs], gastrointestinal agents), office and emergency-department encounters, and hospitalizations before and after the PA policy was implemented on November 16, 1999. A secondary analysis evaluated these changes among a sample of prior NSAID users. RESULTS: After the PA policy was implemented, use of celecoxib was immediately reduced from 1.07 to 0.53 days' supply per person-year (58.9%; 95% CI, 50.0%-67.9%). The monthly rate of increase was also reduced (P < 0.001). Utilization changes were not observed in other drug classes. Similar changes were observed in the secondary analysis. An 18% (95% CI, 2.2%-33.9%) nonsignificant increase in emergency-department visits was observed in the entire sample after the PA policy was implemented. However, a similar change was not observed in the secondary analysis of prior NSAID users. No other changes in medical service encounters were noted after the PA policy was activated. CONCLUSIONS: This observational study found that celecoxib use was substantially reduced after the implementation of a PA policy. No important changes in use of other drug classes were detected. The overall increase in emergency-department visits--although not observed among previous NSAID users--should be explored on the individual level.

Chiropractic and medical care costs of low back care: results from a practice-based observational study.

OBJECTIVE: To compare the 1-year costs for patients treated for acute and chronic ambulatory low back pain by medical physicians and chiropractors. STUDY DESIGN: Prospective, practice-based observational study undertaken in 13 general medical practices and 51 chiropractic community-based clinics. PATIENTS AND METHODS: Of 2872 study patients, 2263 had complete 1-year records of services. Service data, collected from billing records, chart audits, and provider questionnaires, were assigned relative value units that were converted into 1995 dollar costs. Prescription drug costs for medical patients were included. Patient data on health status, pain and disability, and socioeconomic characteristics were obtained from self-administered questionnaires. RESULTS: The direct office costs of treating both chiropractic and medical patients over a 1-year period were relatively small. Forty-three percent of chiropractic patients and 57% of medical patients incurred costs of less than $100. However, the mean costs associated with chiropractic patients ($214) were significantly higher than those for medical patients ($123), especially when compared with medical patients who were not referred for further treatment or evaluation ($103). Chiropractic patients had somewhat lower baseline levels of pain and disability than nonreferred medical patients, but the 2 groups were relatively similar on most patient characteristics. There also were no statistically significant differences in the improvements in pain and disability between these 2 groups of patients. CONCLUSION: The results of this study indicate that patients treated in chiropractic clinics incur higher costs over a 1-year period, but have about the same degree of relief as nonreferred patients treated in medical clinics.

Kaiser Permanente's Convergent Medical Terminology.

This paper describes Kaiser Permanente's (KP) enterprise-wide medical terminology solution, referred to as our Convergent Medical Terminology (CMT). Initially developed to serve the needs of a regional electronic health record, CMT has evolved into a core KP asset, serving as the common terminology across all applications. CMT serves as the definitive source of concept definitions for the organization, provides a consistent structure and access method to all codes used by the organization, and is KP's language of interoperability, with cross-mappings to regional ancillary systems and administrative billing codes. The core of CMT is comprised of SNOMED CT, laboratory LOINC, and First DataBank drug terminology. These are integrated into a single poly-hierarchically structured knowledge base. Cross map sets provide bi-directional translations between CMT and ancillary applications and administrative billing codes. Context sets provide subsets of CMT for use in specific contexts. Our experience with CMT has lead us to conclude that a successful terminology solution requires that: (1) usability considerations are an organizational priority; (2) "interface" terminology is differentiated from "reference" terminology; (3) it be easy for clinicians to find the concepts they need; (4) the immediate value of coded data be apparent to clinician user; (5) there be a well defined approach to terminology extensions. Over the past several years, there has been substantial progress made in the domain coverage and standardization of medical terminology. KP has learned to exploit that terminology in ways that are clinician-acceptable and that provide powerful options for data analysis and reporting.

Categorization of allergic disorders in the new World Health Organization International Classification of Diseases.

BACKGROUND: Although efforts to improve the classification of hypersensitivity/allergic diseases have been made, they have not been considered a top-level category in the International Classification of Diseases (ICD)-10 and still are not in the ICD-11 beta phase linearization. ICD-10 is the most used classification system by the allergy community worldwide but it is not considered as appropriate for clinical practice. The Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) on the other hand contains a tightly integrated classification of hypersensitivity/allergic disorders based on the EAACI/WAO nomenclature and the World Health Organization (WHO) may plan to align ICD-11 with SNOMED CT so that they share a common ontological basis. METHODS: With the aim of actively supporting the ongoing ICD-11 revision and the optimal practice of Allergology, we performed a careful comparison of ICD-10 and 11 beta phase linearization codes to identify gaps, areas of regression in allergy coding and possibly reach solutions, in collaboration with committees in charge of the ICD-11 revision. RESULTS: We have found a significant degree of misclassification of terms in the allergy-related hierarchies. This stems not only from unclear definitions of these conditions but also the use of common names that falsely imply allergy. The lack of understanding of the immune mechanisms underlying some of the conditions contributes to the difficulty in classification. CONCLUSIONS: More than providing data to support specific changes into the ongoing linearization, these results highlight the need for either a new chapter entitled Hypersensitivity/Allergic Disorders as in SNOMED CT or a high level structure in the Immunology chapter in order to make classification more appropriate and usable.

Use of commercial anti-penicillin IgE fluorometric enzyme immunoassays to diagnose penicillin allergy.

BACKGROUND: The intermittent unavailability of penicilloyl-polylysine since September 2000 has focused interest on commercial anti-penicillin IgE fluorometric enzyme immunoassay (FEIA) tests to evaluate penicillin allergy. There has been no published comparison of commercial anti-penicillin IgE FEIAs and penicillin skin testing performed in the United States. OBJECTIVE: To determine whether the current commercial anti-penicillin IgE FEIAs can replace or augment penicillin skin testing and oral challenges when evaluating individuals with a history of penicillin allergy for future therapeutic penicillin tolerance. METHODS: A prospective convenience sample of 150 individuals with a history of penicillin allergy were evaluated between January 23, 2007, and August 4, 2009, with both penicillin skin tests and commercial anti-penicillin IgE FEIAs to penicillin G, penicillin V, and amoxicillin. All individuals with a negative penicillin skin test result underwent oral penicillin class antibiotic challenges. All individuals with a positive anti-penicillin IgE FEIA result also underwent oral penicillin class antibiotic challenges. RESULTS: Six individuals (4.0%; 95% confidence interval [CI], 0.9% to 7.1%) had positive penicillin skin test results, and none had positive FEIA results. Four individuals (2.7%; 95% CI, 0.1% to 5.3%) had positive FEIA results, and none had positive penicillin skin test results. Three individuals (2.0%; 95% CI, -0.2% to 4.2%) had positive oral challenge results, 1 with hives at 6 hours after challenge and 2 with delayed-onset (at >24 hours) nonurticarial rashes, and none had positive FEIA results. CONCLUSIONS: The current commercial anti-penicillin IgE FEIAs are not useful in diagnosing penicillin allergy in patients with remote histories of penicillin allergy. Penicillin skin testing and, if the results are negative, an oral challenge remain the criterion standard tests to determine therapeutic penicillin tolerance.

The association of family continuity with infant health service use.

PURPOSE: Continuity of care is a fundamental component of family medicine that has been shown to improve health care quality. Family continuity, when different family members are seen by the same clinician or practice, has not been well studied. METHODS: We performed a retrospective cohort study of Medicaid enrollees in Oregon using administrative data. Infants were determined to have family continuity if they received well-baby care at the same clinic as that in which their mothers received prenatal care. RESULTS: Of the 1591 infants identified for participation in this study, 749 (47.1%) had family continuity. Infants had a mean of 4.55 well-child visits, 1.23 emergency department visits, and 0.17 hospitalizations in the first 13 months of life. Multivariate analyses found that infants with family continuity had increased numbers of well-child visits (relative risk, 1.05; P = .041), increased numbers of emergency department visits (relative risk, 1.36; P < .0001), and no difference in the number of hospitalizations (relative risk, 0.85; P = .282) when compared with infants without family continuity. CONCLUSIONS: Family continuity, when measured at the clinic level, is associated with a variable effect on infant health service use. This finding suggests that clinic-level continuity is not sufficient for achieving all the benefits of continuity.

Detection of IgE antibodies to bacitracin using a commercially available streptavidin-linked solid phase in a patient with anaphylaxis to triple antibiotic ointment.

BACKGROUND: Bacitracin is a commonly used topical antibiotic that has on occasion been reported to cause anaphylaxis. Evidence of the role of bacitracin specific IgE in such reactions has been demonstrated by skin testing. Because of the potential for provoking a systemic reaction by skin testing, it would be advantageous to develop an in vitro test for bacitracin specific IgE. OBJECTIVE: To report our experience coupling bacitracin to a solid phase and using it to detect specific IgE to bacitracin by fluorescent enzyme immunoassay. METHODS: A patient with a history of recurrent anaphylaxis that developed after application of triple antibiotic ointment to an open wound underwent skin testing with triple antibiotic ointment. Bacitracin was biotinylated and coupled to streptavidin ImmunoCAPs. IgE against bacitracin in the patient's serum was detected by fluorescent enzyme immunoassay. RESULTS: Topical application of triple antibiotic ointment to intact skin produced a 7 X 8-mm wheal with pseudopods. IgE against bacitracin was detected using biotinylated bacitracin-streptavidin ImmunoCAPs at a level of approximately 0.6 KUA/L and confirmed with ImmunoCAPs using direct coupling of bacitracin to the solid phase. CONCLUSIONS: We demonstrate the presence of IgE antibodies to bacitracin in a patient with anaphylaxis to triple antibiotic ointment using a recently described procedure for producing custom allergen solid phases for immunoassay.

Penicilloyl-polylysine stability and clinical use over time.

BACKGROUND: The major penicillin skin test reagent, penicilloyl-polylysine, has not been commercially available since October 2004. The minimal concentration of penicilloyl-polylysine necessary for safe penicillin skin testing has not been determined. METHODS: Penicillin skin testing was performed on 596 individuals between October 2004 and October 2006 using out-of-date commercially produced penicilloyl-polylysine as part of a complete panel of reagents. The concentration of active penicilloyl-polylysine was measured. Outcomes were compared with those for 921 individuals tested between October 2002 and September 2004 using in-date commercially produced penicilloyl-polylysine. RESULTS: There was no significant difference in the fraction of patients who had positive skin test results using indate (5.1%) versus out-of-date (4.7%) penicilloyl-polylysine. There were four mild but no serious adverse reactions in the patients tested with the outdated reagent who were then challenged with oral penicillin class antibiotics. CONCLUSION: Penicillin skin testing can be safely done using penicilloyl-polylysine down to a concentration of 4.29 × 10(-5) M.

A practice-based study of patients with acute and chronic low back pain attending primary care and chiropractic physicians: two-week to 48-month follow-up.

OBJECTIVE: This study reports pain and disability outcomes up to 4 years for chiropractic and medical patients with low back pain (LBP) and assesses the influence of doctor type and pain duration on clinical outcomes. DESIGN: Prospective, longitudinal, nonrandomized, practice-based, observational study. SETTING: Fifty-one chiropractic and 14 general practice community clinics. SUBJECTS: A total of 2870 acute and chronic ambulatory patients with LBP of mechanical origin. METHODS: Sixty chiropractic (DC) and 111 general practice (MD) physicians participated. Primary outcomes were pain, using a 100-point visual analogue scale (VAS), and functional disability, using the Revised Oswestry Disability Questionnaire. These were measured at baseline and 8 time points. Regression analysis compared acute and chronic DC and MD patients after correcting for baseline differences in the 4 cohorts. RESULTS: Most improvement was seen by 3 months and sustained for 1 year; exacerbation was seen thereafter. Acute patients demonstrated greater relief at all time points. A clinically important advantage for chiropractic patients was seen in chronic patients in the short-term (>10 VAS points), and both acute and chronic chiropractic patients experienced somewhat greater relief up to 1 year (P<.000). The advantage for DC care was prominent for chronic patients with leg pain below the knee (P<.001). More than 50% of chronic patients had over 50 days of pain in the third year. CONCLUSION: Study findings were consistent with systematic reviews of the efficacy of spinal manipulation for pain and disability in acute and chronic LBP. Patient choice and interdisciplinary referral should be prime considerations by physicians, policymakers, and third-party payers in identifying health services for patients with LBP.