Preparing Patients for Oral Immunotherapy (PPOINT): International Delphi consensus for procedural preparation and consent.

BACKGROUND: Despite the promise of oral immunotherapy (OIT) to treat food allergies, this procedure is associated with potential risk. There is no current agreement about what elements should be included in the preparatory or consent process. OBJECTIVE: We developed consensus recommendations about the OIT process considerations and patient-specific factors that should be addressed before initiating OIT and developed a consensus OIT consent process and information form. METHODS: We convened a 36-member Preparing Patients for Oral Immunotherapy (PPOINT) panel of allergy experts to develop a consensus OIT patient preparation, informed consent process, and framework form. Consensus for themes and statements was reached using Delphi methodology, and the consent information form was developed. RESULTS: The expert panel reached consensus for 4 themes and 103 statements specific to OIT preparatory procedures, of which 76 statements reached consensus for inclusion specific to the following themes: general considerations for counseling patients about OIT; patient- and family-specific factors that should be addressed before initiating OIT and during OIT; indications for initiating OIT; and potential contraindications and precautions for OIT. The panel reached consensus on 9 OIT consent form themes: benefits, risks, outcomes, alternatives, risk mitigation, difficulties/challenges, discontinuation, office policies, and long-term management. From these themes, 219 statements were proposed, of which 189 reached consensus, and 71 were included on the consent information form. CONCLUSION: We developed consensus recommendations to prepare and counsel patients for safe and effective OIT in clinical practice with evidence-based risk mitigation. Adoption of these recommendations may help standardize clinical care and improve patient outcomes and quality of life.

Bedroom exposure to airborne allergens in the Chicago area using a patient-operated sampling device.

BACKGROUND: In current practice, allergens in vacuum-collected dust are used as surrogates for inhalable allergens. We developed an air-sampling device that can be used by patients for direct measurement of airborne allergen concentrations in their own homes. OBJECTIVE: To demonstrate the use of this device to establish allergen concentration reference ranges in a target population and to evaluate associations between patient-reported information and measured allergen concentrations. METHODS: Patients from 5 allergist's practices in the Chicagoland region were provided with instructions, questionnaires, informed consent forms, and samplers to run for 5 days in their bedrooms. Samples were collected from cartridges and assayed by multiplex immunoassays for 12 common household allergens and enzyme-linked immunosorbent assay for ragweed. RESULTS: Unique allergen profiles were obtained for 102 patient homes. Samples with allergen concentrations above the limit of detection were as follows: total dust mite, 28%; cat, 61%; dog, 64%; mouse, 12%; rat, 0%; cockroach, 4%; Alternaria, 6%; Aspergillus, 21%; birch pollen 1%; grass, 8%; and ragweed, 5%. Of those, 75 completed questionnaires, providing meta-data for further analysis. Pet allergens correlated significantly with number of pets owned. Humidity correlated with dust mite allergens, open windows with Alternaria and mouse allergens, and high-efficiency particulate air filter use with reduced levels of several allergens. Many other variables showed no significant correlations. CONCLUSION: The combination of ease of use, high air-sampling rate, and sensitive immunoassays permitted the measurement of airborne allergen concentrations in homes and establishment of reference ranges. Patient-reported information permitted identification of factors that could relate to allergen concentrations and suggested remedial measures.

Success of a comprehensive school-based asthma intervention on clinical markers and resource utilization for inner-city children with asthma in Chicago: the Mobile C.A.R.E. Foundation's asthma management program.

Children with asthma in low-income households in Chicago were participants in a school-based mobile van clinic, Mobile C.A.R.E. Our objective was to investigate whether long-term follow-up changed clinical markers and resource utilization. Children were evaluated by a pediatrician in a mobile allergy clinic and classified and treated based on National Asthma Education and Prevention Program (NAEPP) guidelines. Intervention consisted of assessment of allergic environment with avoidance recommendations, institution of appropriate controller therapy and inhaler technique, education on asthma and asthma management, and expectations for asthma control. Over 20,000 children were screened, 2041 were examined at least once, and 677 children had four follow-up visits. With follow-up, there was a decrease in hospitalizations and emergency room visits. Symptomatic markers (daytime and nighttime cough, wheezing, and dyspnea symptoms), frequency of rescue inhaler use, and a quality-of-life score improved from baseline. These findings suggest that ongoing school interventions may reduce resource utilization and improve clinical symptoms. Primary care physicians may be able to deliver specialized care to large numbers of inner-city children with asthma.

Ketotifen fumarate and olopatadine hydrochloride in the treatment of allergic conjunctivitis: a real-world comparison of efficacy and ocular comfort.

This 3-week prospective, randomized, double-masked, parallel-group study compared ketotifen fumarate 0.025% ophthalmic solution and olopatadine hydrochloride 0.1% ophthalmic solution in 66 patients with seasonal allergic conjunctivitis. The drugs were instilled twice daily. Signs and symptoms were assessed on days 5 (visit 2) and 21 (visit 3). Other efficacy variables were the responder rate (patients with excellent or good global efficacy on days 5 and 21) and patient and investigator ratings of global efficacy. Comfort was evaluated immediately after instillation of the first drop and at each follow-up visit. The frequency of adverse events was the safety assessment. The responder rate was higher with ketotifen than with olopatadine on day 5 (72% vs 54% for patient assessment, 88% vs 55% for investigator assessment) and day 21 (91% vs 55%, 94% vs 42%). Global efficacy ratings were higher with ketotifen, and severity scores for hyperemia and itching were significantly lower. Both drugs elicited comparable comfort ratings. The most common adverse events were burning/stinging and headache.

Atrial fibrillation associated with anaphylaxis during venom and pollen immunotherapy.

BACKGROUND: Electrographic changes after insect stings have been reported both with and without systemic symptoms. To our knowledge, however, there have been no reported cases of arrhythmias in the maintenance phase of venom or pollen immunotherapy. OBJECTIVE: We report a case of a patient who developed paroxysmal atrial fibrillation after receiving venom and pollen immunotherapy. This patient was initially evaluated in an outpatient setting, and the events described occurred at an allergist's private office. We believe this is an atypical presentation and would be very pertinent to the practicing allergist. METHODS: This patient was under the care of a clinical allergist in a private practice with associations to a teaching hospital. Interventions were as described in the body of the paper, more specifically venom and pollen maintenance immunotherapy followed by two doses of 0.3 mL of 1:1,000 concentration epinephrine intramuscularly. RESULTS: Patient was found to be in atrial fibrillation along with systemic symptoms immediately after administration of immunotherapy. After epinephrine administration, patient converted back to normal sinus rhythm and systemic symptoms resolved. CONCLUSIONS: Atrial fibrillation is an atypical presentation of a systemic reaction to immunotherapy.