Behavioral Interventions to Improve Breast Cancer Screening Outreach: Two Randomized Clinical Trials.

Importance: Despite public health efforts, breast cancer screening rates remain below national goals. Objective: To evaluate whether bulk ordering, text messaging, and clinician endorsement increase breast cancer screening rates. Design, Setting, and Participants: Two concurrent, pragmatic, randomized clinical trials, each with a 2-by-2 factorial design, were conducted between October 25, 2021, and April 25, 2022, in 2 primary care regions of an academic health system. The trials included women aged 40 to 74 years with at least 1 primary care visit in the past 2 years who were eligible for breast cancer screening. Interventions: Patients in trial A were randomized in a 1:1 ratio to receive a signed bulk order for mammogram or no order; in a factorial design, patients were concurrently randomized in a 1:1 ratio to receive or not receive text message reminders. Patients in trial B were randomized in a 1:1 ratio to receive a message signed by their primary care clinician (clinician endorsement) or from the organization (standard messaging); in a factorial design, patients were concurrently randomized in a 1:1 ratio to receive or not receive text message reminders. Main Outcomes and Measures: The primary outcome was the proportion of patients who completed a screening mammogram within 3 months. Results: Among 24 632 patients included, the mean (SD) age was 60.4 (7.5) years. In trial A, at 3 months, 15.4% (95% CI, 14.6%-16.1%) of patients in the bulk order arm and 12.7% (95% CI, 12.1%-13.4%) in the no order arm completed a mammogram, showing a significant increase (absolute difference, 2.7%; 95% CI, 1.6%-3.6%; P < .001). In the text messaging comparison arms, 15.1% (95% CI, 14.3%-15.8%) of patients receiving a text message completed a mammogram compared with 13.0% (95% CI, 12.4%-13.7%) of those in the no text messaging arm, a significant increase (absolute difference of 2.1%; 95% CI, 1.0%-3.0%; P < .001). In trial B, at 3 months, 12.5% (95% CI, 11.3%-13.7%) of patients in the clinician endorsement arm completed a mammogram compared with 11.4% (95% CI, 10.3%-12.5%) of those in the standard messaging arm, which was not significant (absolute difference, 1.1%; 95% CI, -0.5% to 2.7%; P = .18). In the text messaging comparison arms, 13.2% (95% CI, 12.0%-14.4%) of patients receiving a text message completed a mammogram compared with 10.7% (95% CI, 9.7%-11.8%) of those in the no text messaging arm, a significant increase (absolute difference, 2.5%; 95% CI, 0.8%-4.0%; P = .003). Conclusions and Relevance: These findings show that text messaging women after initial breast cancer screening outreach via either electronic portal or mailings, as well as bulk ordering with or without text messaging, can increase mammogram completion rates. Trial Registration: ClinicalTrials.gov Identifier: NCT05089903.

Practical alternative to hospitalization for emergency department patients (PATH): A feasibility study.

OBJECTIVE: We sought to determine the feasibility of the Practical Alternative to Hospitalization (PATH) program, an intervention that offers ED clinicians an outpatient care pathway for patients initially designated for inpatient admission or observation. METHODS: We evaluated a novel care delivery model that was piloted at a tertiary academic medical center in December 2019. An advanced practice provider screened patients designated for inpatient admission or observation and identified eligible participants. Outpatient services were customized for each patient but primarily included care coordination and monitoring through telemedicine and home health services. The primary feasibility outcome was the proportion of eligible patients who were enrolled in the program, as well as patient outcomes after discharge including return ED visits and averted ED boarding time. RESULTS: A total of 199 patients were designated for inpatient admission or observation during PATH program hours. Of 52 eligible patients, 30 (58%) were enrolled. The mean participant age was 62.5 years (SD 17.5), and 25 (83%) had non-Hispanic Black race/ethnicity. The most common disease conditions were chest pain, heart failure, and hyperglycemia. 4 (13%) enrolled patients returned to an ED within 30 days. We estimate that ED boarding time was reduced by 8.2 h (SD 8.1) per patient. CONCLUSION: Emergency physicians and patients were willing to use a novel service that provided an alternative disposition to hospitalization. IMPLICATIONS: alternative payment models that seek to reduce hospital utilization and cost may consider strengthening systems to monitor and coordinate care for patients after ED discharge.

First-to-invent versus first-to-file: impact of the AIA.

On March 16, 2013, the USPTO switched from a 'first-to-invent' to a 'first-to-file' patent system. Under the 2011 America Invents Act, patents will be awarded to the first inventor to file a patent application as opposed to the date of invention. Now, over a year since the main provisions of the America Invents Act (AIA) came into effect, Pharmaceutical Patent Analyst has invited a selection of IP specialists and researchers from the US to discuss the implications of this new law and how it will affect future pharmaceutical and medical R&D. Interview conducted by Alexandra Sklan, Commissioning Editor.

Prenatal and postnatal bisphenol A exposure and asthma development among inner-city children.

BACKGROUND: Bisphenol A (BPA) is used widely to manufacture food container linings. Mouse models suggest exposure to BPA might increase allergic inflammation. OBJECTIVES: We hypothesized that BPA exposure, as assessed based on urinary BPA concentrations, would be associated with increased odds of wheeze and asthma and increased fraction of exhaled nitric oxide (Feno) values in children. METHODS: The Columbia Center for Children's Environmental Health recruited pregnant women for a prospective birth cohort study (n = 568). Mothers during the third trimester and children at ages 3, 5, and 7 years provided spot urine samples. Total urinary BPA concentrations were measured by using online solid-phase extraction, high-performance liquid chromatography, isotope-dilution tandem mass spectrometry. Wheeze in the last 12 months was measured by using questionnaires at ages 5, 6, and 7 years. Asthma was determined by a physician once between ages 5 and 12 years. Feno values were measured at ages 7 to 11 years. RESULTS: Prenatal urinary BPA concentrations were associated inversely with wheeze at age 5 years (odds ratio [OR], 0.7; 95% CI, 0.5-0.9; P = .02). Urinary BPA concentrations at age 3 years were associated positively with wheeze at ages 5 years (OR, 1.4; 95% CI, 1.1-1.8; P = .02) and 6 years (OR, 1.4; 95% CI, 1.0-1.9; P = .03). BPA concentrations at age 7 years were associated with wheeze at age 7 years (OR, 1.4; 95% CI, 1.0-1.9; P = .04) and Feno values (ß = 0.1; 95% CI, 0.02-0.2; P = .02). BPA concentrations at ages 3, 5, and 7 years were associated with asthma (OR, 1.5 [95% CI, 1.1-2.0], P = .005; OR, 1.4 [95% CI, 1.0-1.9], P = .03; and OR, 1.5 [95% CI, 1.0-2.1], P = .04, respectively). CONCLUSIONS: This is the first report of an association between postnatal urinary BPA concentrations and asthma in children.

Icatibant, a new bradykinin-receptor antagonist, in hereditary angioedema.

BACKGROUND: Hereditary angioedema is characterized by recurrent attacks of angioedema of the skin, larynx, and gastrointestinal tract. Bradykinin is the key mediator of symptoms. Icatibant is a selective bradykinin B2 receptor antagonist. METHODS: In two double-blind, randomized, multicenter trials, we evaluated the effect of icatibant in patients with hereditary angioedema presenting with cutaneous or abdominal attacks. In the For Angioedema Subcutaneous Treatment (FAST) 1 trial, patients received either icatibant or placebo; in FAST-2, patients received either icatibant or oral tranexamic acid, at a dose of 3 g daily for 2 days. Icatibant was given once, subcutaneously, at a dose of 30 mg. The primary end point was the median time to clinically significant relief of symptoms. RESULTS: A total of 56 and 74 patients underwent randomization in the FAST-1 and FAST-2 trials, respectively. The primary end point was reached in 2.5 hours with icatibant versus 4.6 hours with placebo in the FAST-1 trial (P=0.14) and in 2.0 hours with icatibant versus 12.0 hours with tranexamic acid in the FAST-2 trial (P<0.001). In the FAST-1 study, 3 recipients of icatibant and 13 recipients of placebo needed treatment with rescue medication. The median time to first improvement of symptoms, as assessed by patients and by investigators, was significantly shorter with icatibant in both trials. No icatibant-related serious adverse events were reported. CONCLUSIONS: In patients with hereditary angioedema having acute attacks, we found a significant benefit of icatibant as compared with tranexamic acid in one trial and a nonsignificant benefit of icatibant as compared with placebo in the other trial with regard to the primary end point. The early use of rescue medication may have obscured the benefit of icatibant in the placebo trial. (Funded by Jerini; ClinicalTrials.gov numbers, NCT00097695 and NCT00500656.)

Diagnosis and treatment of human seminal plasma hypersensitivity.

BACKGROUND: Human seminal plasma hypersensitivity is a rare disorder that is often misdiagnosed. While this disorder is well described in the allergy and immunology literature, few cases exist in the gynecologic literature. CASE: A young woman presented to our allergy clinic with recurrent vaginal burning, swelling, and itching occurring approximately 10 minutes postcoitally. Semen allergy was suspected. Using her partner's semen, intradermal testing produced 1.6-cm wheal and 6.0-cm flare. The patient underwent intravaginal desensitization, and she and her partner were instructed to have intercourse every 48 hours to maintain desensitization. At 5-month follow-up, they were practicing coitus interruptus with success. CONCLUSION: Human seminal plasma hypersensitivity may mimic chronic vaginitis. The intravaginal graded challenge, a form of immunotherapy used by allergists, remains a mainstay in treatment, but is only effective if maintained correctly.

A generalized reaction to thimerosal from an influenza vaccine.

BACKGROUND: Thimerosal is a preservative commonly used in ophthalmic solutions, otic drops, and vaccines because of its bactericidal property. OBJECTIVE: To report a case of a generalized reaction to thimerosal in a patient who received an influenza vaccine. METHODS: We describe a patient who developed a generalized maculopapular eruption after receiving a thimerosal-containing influenza vaccine. Patch testing was performed to determine if there was an allergy to thimerosal. RESULTS: Patch testing confirmed a T-cell-mediated sensitivity to thimerosal. CONCLUSIONS: Physicians need to be aware that thimerosal is found in many products, including vaccinations. Clinicians should also be aware that allergic reactions occur with exposure to thimerosal even in vaccines. To our knowledge, this is the first case report in the literature of a generalized reaction to thimerosalfrom an influenza vaccine.

Localized seminal plasma protein hypersensitivity.

Human seminal plasma protein hypersensitivity is a rare disorder. Since the first case report in 1958, allergic reactions to semen have gone relatively unnoticed or improperly diagnosed. Dozens of medical case reports and research prove that allergy to seminal fluid is a legitimate health concern.

The approach to conception for women with seminal plasma protein hypersensitivity.

PROBLEM: Allergic reactions to human seminal plasma protein has become increasingly recognized in the medical community. Treatment for most allergic conditions usually begins with avoidance of the offending allergen. For women with seminal plasma protein hypersensitivity (SPH) who desire to conceive, this approach is unacceptable. We describe a case report of a woman with an SPH who desired to have unprotected intercourse in order to conceive. METHODS: The patient underwent skin prick testing to her fiancé's fresh undiluted semen. Serum-specific IgG and IgE was performed by ELISA to the fiancé's whole seminal plasma and seminal plasma proteins (SPP). The patient underwent an intravaginal graded challenge to whole seminal fluid. Intrauterine insemination with washed spermatozoa was attempted but in vitro fertilization was subsequently required. RESULTS: The patient had a positive prick test to whole seminal plasma but negative specific IgG and IgE ELISA to SPPs. An intravaginal graded challenge to whole seminal plasma was well tolerated. However, she experienced a subsequent severe local reaction after unprotected intercourse. She deferred treatment with systemic desensitization to relevant SPPs. She failed intrauterine insemination but successfully conceived with in vitro fertilization. CONCLUSION: This case report emphasizes that SPH is not associated with sterility. It also indicates that whole seminal plasma graded challenge is not uniformly successful for the treatment of SPH.

An individualized intervention to improve asthma management among urban Latino and African-American families.

We hypothesized that an educational intervention based on a readiness model would lead to improved health outcomes among patients with asthma. Within a randomized control design in an urban Latino and African-American community we conducted an intensive three-month pediatric intervention. A Family Coordinator provided patient education based on a readiness-to-learn model, and facilitated improved interactions between the patient and the doctor. Family education addressed the most basic learning needs of patients with asthma by improving their perception of asthma symptom persistence using asthma diaries and peak flown measures. The physician intervention focused cliniciancs' attention on patients' diary records and peak flow measures, and encouraged physicians to use stepped action plans. Patients were also tested for allergic sensitization and provided strategies to reduce contact with allergens and other asthma triggers. The results showed significant improvements by intervention group families on measures of knowledge, health belief, self-efficacy, self-regulatory skill, and adherence; decreases in symptom persistence and activity restriction; and increased prescription of anti-inflammatory medication by the physicians of the intervention group families.

Case report of an anaphylactoid reaction to arginine.

BACKGROUND: Arginine is an agent commonly used to evaluate adequacy of growth hormone (GH) secretion. Because arginine is a simple amino acid, it is considered safe and rarely causes adverse reactions. OBJECTIVE: To report the second anaphylactoid reaction to arginine in a child undergoing stimulation testing with arginine for assessing GH secretion. METHODS: Allergy skin testing to arginine was performed with a protocol similar to penicillin testing 4 weeks after the anaphylactoid reaction. RESULTS: Testing revealed a positive response to the arginine. CONCLUSIONS: The use of intravenous arginine as a test of GH reserve remains safe and effective, but it is prudent to have the equipment and medication available to treat an allergic reaction.