16 research outputs found
Can the Brighton Collaboration case definitions be used to improve the quality of Adverse Event Following Immunization (AEFI) reporting? Anaphylaxis as a case study
No full textThe Brighton Collaboration (BC) was established in 2000 with the aim of developing globally accepted standardized case definitions for adverse events following immunizations (AEFI) as well as guidelines for the collection, analysis and presentation of surveillance data. Some of the BC case definitions are complex and this may limit their application for use in post-marketing vaccine surveillance. Barriers to the application of the BC case definitions include an incomplete description of an adverse event and inconsistencies in reporter use of adverse event terms. We have taken the BC case definition for anaphylaxis and developed a clinical checklist and glossary of terms used in the case definition. It is anticipated that these resources can be used at a community level by AEFI reporters. If used, these resources could improve the quality of adverse event reports which would facilitate the application of the BC case definition at a regional and/or national level.Michael S. Gold, Jane Gidudu, Mich Erlewyn-Lajeunesse, Barbara Law and Brighton Collaboration Working Group on Anaphylaxi
Anaphylaxis: revision of the Brighton Collaboration case definition (Manuscript Draft)
No full textThe Brighton Collaboration (BC) has formulated a number of case definitions which have primarily been applied to adverse events of special interest in the context of vaccine safety surveillance. This is a revision of the 2007 BC case definition for anaphylaxis. Recently, the BC definition has been widely used for evaluating reports of suspected anaphylaxis following COVID-19 vaccination. This has led to debate about the performance of the BC definition in comparison with those from the US National Institute of Allergy and Infectious Disease/Food Allergy Anaphylaxis Network (NIAID/FAAN) and the World Allergy Organization (WAO). BC convened an expert working group to revise the case definition based on their usual process of literature review and expert consensus. This manuscript presents the outcome of this process and proposes a revised case definition for anaphylaxis. Major and minor criteria have been re-evaluated with an emphasis on the reporting of observable clinical signs, rather than subjective symptoms, and a clearer approach to the ascertainment of levels of certainty is provided. The BC case definition has also been aligned with other contemporary and international case definitions for anaphylaxis.The SPEAC Project is funded in whole by CEPI
Anaphylaxis: case definition and guidelines for data collection, analysis, and presentation of immunization safety data
No full textJens U. Rüggeberg, Michael S. Gold, José-Maria Bayas, Michael D. Blum, Jan Bonhoeffer, Sheila Friedlander, Glacus de Souza Brito, Ulrich Heininger, Babatunde Imoukhuede, Ali Khamesipour, Michel Erlewyn-Lajeunesse, Susana Martin, Mika Mäkelä, Patricia Nell, Vitali Pool, Nick Simpson and The Brighton Collaboration Anaphylaxis Working Grouphttp://www.elsevier.com/wps/find/journaldescription.cws_home/30521/description#descriptio
Anaphylaxis: Case Definition Pictorial Algorithm
No full textThis post contains the Pictorial Algorithm for Anaphylaxis. They are included in the case definition companion guides, which contain resources and tools specific to events that have a published Brighton Collaboration case definition.The SPEAC project is funded by CEPI
J Allergy Clin Immunol
No full textBackgroundAnaphylaxis is a potentially life-threatening allergic reaction. The risk of anaphylaxis after vaccination has not been well described in adults or with newer vaccines in children.ObjectiveWe sought to estimate the incidence of anaphylaxis after vaccines and describe the demographic and clinical characteristics of confirmed cases of anaphylaxis.MethodsUsing health care data from the Vaccine Safety Datalink, we determined rates of anaphylaxis after vaccination in children and adults. We first identified all patients with a vaccination record from January 2009 through December 2011 and used diagnostic and procedure codes to identify potential anaphylaxis cases. Medical records of potential cases were reviewed. Confirmed cases met the Brighton Collaboration definition for anaphylaxis and had to be determined to be vaccine triggered. We calculated the incidence of anaphylaxis after all vaccines combined and for selected individual vaccines.ResultsWe identified 33 confirmed vaccine-triggered anaphylaxis cases that occurred after 25,173,965 vaccine doses. The rate of anaphylaxis was 1.31 (95% CI, 0.90-1.84) per million vaccine doses. The incidence did not vary significantly by age, and there was a nonsignificant female predominance. Vaccine-specific rates included 1.35 (95% CI, 0.65-2.47) per million doses for inactivated trivalent influenza vaccine (10 cases, 7,434,628 doses given alone) and 1.83 (95% CI, 0.22-6.63) per million doses for inactivated monovalent influenza vaccine (2 cases, 1,090,279 doses given alone). The onset of symptoms among cases was within 30 minutes (8 cases), 30 to less than 120 minutes (8 cases), 2 to less than 4 hours (10 cases), 4 to 8 hours (2 cases), the next day (1 case), and not documented (4 cases).ConclusionAnaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat.CC999999/Intramural CDC HHSUnited States/T32 AI074492/AI/NIAID NIH HHSUnited States
A clinical approach to the investigation of suspected vaccine anaphylaxis
No full textVaccine anaphylaxis is rare, despite the increased incidence of atopic disease and food allergies and an increase in the number of vaccines administered to young children. The mechanism of vaccine anaphylaxis is poorly understood and may be IgE- or non-IgE- mediated. The first step is to assess if the reported symptoms and signs are consistent with anaphylaxis, using the Brighton Collaboration case definition of anaphylaxis. Skin-prick and intradermal testing may support the diagnosis. If vaccine anaphylaxis is diagnosed, re-vaccination with the same vaccine antigens or other vaccines containing the same excipients is contraindicated, but the risk of anaphylaxis to other vaccines is not increased. The measles, mumps, rubella (MMR) and influenza vaccines are safe in egg-allergic children. Influenza vaccination in children with egg anaphylaxis may be given under specialist medical supervision. Misdiagnosis of vaccine anaphylaxis may prevent an individual from receiving vaccinations, possibly resulting in a vaccine-preventable illness. All healthcare providers must report suspected vaccine anaphylaxis and record in detail all symptoms and signs when they occur. Signs and symptoms suggestive of anaphylaxis following vaccination should be managed as anaphylaxis and the vaccinee treated with intramuscular adrenaline.Michael Goldhttp://www.sabinet.co.za/abstracts/caci/caci_v25_n2_a3.htm
Diagnostic utility of two case definitions for anaphylaxis: a comparison using a retrospective case notes analysis in the UK
No full textBackground: anaphylaxis is a clinical diagnosis with no gold-standard test. Recent case definitions have attempted to provide objective criteria for diagnosis.Objective: the aim of this study was to compare the diagnostic concordance of the Brighton Collaboration case definition (the ‘Brighton’ case definition) to the consensus case definition from the Second Symposium on the Definition and Management of Anaphylaxis (the ‘Symposium’ definition).Method: the study setting was a hospital-based emergency department in the UK. We identified cases of anaphylaxis by physicians’ discharge diagnoses over a 2-year period from 2005 to 2006, and used randomly selected cases of allergic reaction, asthma and urticaria as a control group. Data was extracted by clinicians (who were unaware of the content of either case definition), and the two case definitions were applied by Boolean operators in a Microsoft® Excel spreadsheet. Concordance between the case definitions was measured using Cohen’s kappa (κ) statistic.Results: we reviewed 128 sets of notes, with 47 cases of anaphylaxis. Brighton and Symposium definitions had sensitivities of 0.681 and 0.671, respectively, and specificities of 0.790 and 0.704, respectively. A discordant result was found in 36/128 cases (28.1%; κ = 0.414 [95% CI 0.253, 0.574]), which represents a moderate level of agreement between case definitions.Conclusions: the Brighton case definition has a similar diagnostic concordance to the Symposium case definition. It does not seem to over-or underestimate cases and is sufficiently unique that the identification of an allergic trigger does not have to form part of the case definition. This will be important in the recognition of anaphylaxis resulting from the administration of drug and vaccines, where causality should be examined separately from case ascertainment
Positive predictive value of ICD-10 codes to detect anaphylaxis due to vaccination: A validation study
No full textPURPOSE: To validate the use of selected International Classification of Disease Codes 10th revision (ICD-10) to predict (positive predictive value) anaphylaxis due to vaccination using emergency department (ED) data. METHODS: We conducted a retrospective study using ED encounter data from a large tertiary-care teaching hospital, Monash Medical Centre, Melbourne, Australia. We searched all ED encounters potentially due to anaphylaxis after vaccination, between 1 January 2010 and 31 December 2018, using ICD-10-CM codes T80.5, T80.6, T88.1, T88.6, and T78.2. Health records of potential cases were examined to determine if they met the Brighton Collaboration (BC) criteria for anaphylaxis. We calculated the PPV to evaluate the accuracy of the selected ICD-10-CM codes in predicting anaphylaxis due to vaccination. RESULTS: Of the 69 health records identified and reviewed, 29 (42.2%) met the criteria for anaphylaxis regardless of the cause, and 24.6% (17/69) of records were confirmed as anaphylaxis triggered by vaccination (low positive predictive value). However, of the 23 records identified using ICD-10-CM code T80.5, 22 were classified as anaphylaxis cases regardless of the cause, and 12 were anaphylaxis due to vaccination cases giving PPV of 95.7% and 52.2%, respectively. CONCLUSIONS: Given that there is no specific ICD-10-CM code for anaphylaxis due to vaccination, ICD-10-CM code T80.5 may be suitable to monitor anaphylaxis due to vaccination in the ED setting. The current study was conducted at a single centre and needs to be confirmed by future multicentre studies
Use of adrenaline to manage suspected anaphylaxis following COVID-19 vaccination : an Australian retrospective cohort study
No full textBackground: The rate of anaphylaxis following COVID-19 vaccinations is estimated to be 2–11 cases per million doses administered. However, adrenaline is occasionally used in individuals who are later diagnosed with immunisation stress-related responses, as their initial presenting signs and symptoms can appear similar to that of anaphylaxis. This study aims to describe the clinical profile of individuals who had received adrenaline following a COVID-19 vaccine and their subsequent revaccination outcomes. Methods: We examined notifications of cases who had received adrenaline following a COVID-19 vaccine in New South Wales, Australia. The cases were classified into Brighton Collaboration Case Definition (BCCD) for anaphylaxis, their clinical presentation, management and subsequent revaccination outcomes were compared. Results: From 22 February 2021 to 30 September 2021, there were 222 cases where adrenaline was administered. Of these, 32 (14 %) fulfilled Level 1 BCCD, 59 (27%) Level 2, 2 (1%) Level 3, 97 (44%) Level 4 and 32 (14 %) Level 5. The most commonly reported symptoms were sensation of throat closure (n = 116, 52%), difficulty breathing (n = 82, 37%) and nausea (n = 55, 25 %). Of the 176 (79%) individuals who proceeded to further vaccination, 89 (51%) received the same vaccine formulation and only 14 (8%) experienced another allergic adverse event with 9 (5%) receiving adrenaline. Conclusion: Less than one in five individuals who received adrenaline met Level 1 BCCD criteria for anaphylaxis. Many reactions that were treated with adrenaline had little to no diagnostic certainty of anaphylaxis and in such cases repeat vaccination had a high likelihood of being tolerated. Increased awareness and education on objective signs and symptoms of anaphylaxis is required to ensure appropriate use of adrenaline
Interprofessional simulation for nursing and paramedicine students: Community anaphylaxis management following immunization
No full textBackground: Interprofessional simulations are becoming an important aspect of learning for nursing students. Still, the execution of these types of simulations can prove challenging.
Problem: Educational institutions often struggle to access faculties from different health care fields for interprofessional simulations. There is limited literature on operationalizing and implementing interprofessional simulations related to scenarios in the community, which makes creating these simulations challenging.
Approach: Nursing and paramedicine educators from a university and a community college collaborated on a simulation centered on the management of immunization anaphylaxis in the community.
Outcomes: Feedback from facilitators and students was positive. Both disciplines agreed that collaborative learning significantly enhanced role clarification, team functioning, conflict resolution, collaboration, and communication skills with team members. Challenges included coordinating schedules, space, and training of facilitators.
Conclusions: Collaborating with other educational institutions to establish an interprofessional simulation can be complex, but the benefits significantly outweighed the challenges
