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Consensus statements on vaccination in patients with haemophilia-Results from the Italian haemophilia and vaccinations (HEVA) project.

ABSTRACT: Vaccination against communicable diseases is crucial for disease prevention, but this practice poses challenges to healthcare professionals in patients with haemophilia. Poor knowledge of the vaccination requirements for these patients and safety concerns often result in vaccination delay or avoidance. In order to address this issue, a panel of 11 Italian haemophilia and immunization experts conducted a Delphi consensus process to identify the main concerns regarding the safe use of vaccines in patients with haemophilia. The consensus was based on a literature search of the available evidence, which was used by the experts to design 27 consensus statements. A group of clinicians then rated these statements using the 5-point Likert-type scale (1 = strongly disagree; 5 = strongly agree). The main issues identified by the expert panel included vaccination schedule for haemophilic patients; protocol and optimal route of vaccine administration; vaccination of haemophilic patients with antibodies inhibiting coagulation factor VIII (inhibitors); and vaccination and risk of inhibitor development. This manuscript discusses these controversial areas in detail supported by the available literature evidence and provides evidence- and consensus-based recommendations. Overall, participants agreed on most statements, except those addressing the potential role of vaccination in inhibitor formation. Participants agreed that patients with haemophilia should receive vaccinations according to the institutional schedule for individuals without bleeding disorders; however, vaccination of patients with haemophilia requires comprehensive planning, taking into account disease severity, type and route of vaccination, and bleeding risk. Data also suggest vaccination timing does not need to take into consideration when the patient received factor VIII replacement.

SUBMITTER: Santagostino E

PROVIDER: S-EPMC6850056 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Consensus statements on vaccination in patients with haemophilia-Results from the Italian haemophilia and vaccinations (HEVA) project.

Santagostino Elena E Riva Agostino A Cesaro Simone S Esposito Susanna S Matino Davide D Mazzucchelli Renata Ilde RI Molinari Angelo Claudio AC Mura Rosamaria R Notarangelo Lucia Dora LD Tagliaferri Annarita A Di Minno Giovanni G Clerici Mario M

Haemophilia : the official journal of the World Federation of Hemophilia 20190416 4

Vaccination against communicable diseases is crucial for disease prevention, but this practice poses challenges to healthcare professionals in patients with haemophilia. Poor knowledge of the vaccination requirements for these patients and safety concerns often result in vaccination delay or avoidance. In order to address this issue, a panel of 11 Italian haemophilia and immunization experts conducted a Delphi consensus process to identify the main concerns regarding the safe use of vaccines in ...[more]

PMID: 30990961

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Project description:ObjectiveThis study aimed to synthesize available evidence on the effectiveness and safety of COVID-19 vaccines for frail older adults through a rapid review, supplemented with geriatricians' consensus statements.MethodsReferences were identified through MEDLINE and Web of Science on 1st February 2021 using relevant terms related to COVID-19, vaccine, and older adults. Searches were also conducted on reference lists of review articles and Google Scholar. The content was updated on 8th April via hand searching. We included studies on Phase III randomized controlled trials, and data from real world administration of vaccines. A two-round Delphi study was conducted with 15 geriatricians to elicit their thoughts and recommendations regarding COVID-19 vaccination for frail older adults.ResultsFive Phase III randomized controlled efficacy trials reported vaccine efficacy ranging from 66.7% to 95% among participants aged 16 to 95. The vaccine efficacy for participants aged 65 and above is 94.7% and 86.4% for Pfizer-BioNTech and Moderna respectively. Sputnik V reported a vaccine efficacy of 91.8% for participants 60 and above. Serious adverse events were reported by 0.27% to 1% of participants who received at least one dose of the four vaccines. For the Delphi study, 16 out of 24 statements achieved consensus. The Delphi panel opined that frail or very old adults, except those with limited life expectancy, should be vaccinated due to their vulnerability. They also agree that vaccination decisions should be made by patients when possible, with the involvement of next-of-kin should the frail older adult be unable to do so. Lastly, the panel thought that frail older adults should be included in future clinical trials.ConclusionIn early clinical trials, there is paucity of evidence on efficacy and safety of current COVID-19 vaccines among frail older adults. Geriatricians' consensus indicate that frail older adults should be vaccinated except where life expectancy is limited. Future trials assessing efficacy and safety should include frail older adults.

Project description:BACKGROUND:Adult-onset Still's disease (AOSD) is a rare inflammatory condition characterized by fever, rash, and arthritis. Because of its rarity, clinical trials are inherently small and often uncontrolled. Our objective was to develop recommendations for the use of interleukin (IL)-1 inhibitors in the management of patients with AOSD, based on the best evidence and expert opinion. METHODS:A panel of 10 experts (9 rheumatologists and 1 pediatrician) was established. The first step was dedicated to a comprehensive literature review and development of statements. Two separate literature searches were performed on the MEDLINE (Pubmed), EMBASE, and BIOSIS databases through April 2018 to identify (1) differences and similarities between AOSD and pediatric Still's disease (systemic juvenile idiopathic arthritis [SJIA]) and (2) the efficacy and safety of IL-1 inhibitors in AOSD treatment. In the second step, the statements were submitted in a Delphi process to a panel of 67 rheumatologists. Consensus threshold was set at 66%: positive, >?66% of voters selected scores 3 to 5; negative, >?66% of voters selected scores 1 or 2. In the third step, the voting results were analyzed, and the statements were finalized. RESULTS:Eleven statements were developed. Forty-six of 67 rheumatologists (72%) participated in the Delphi process. A positive consensus was reached after the first round of voting and was full (>?95%) on the majority of statements. A large consensus was achieved in considering AOSD and SJIA as the same disease. The use of anti-IL-1 therapies in refractory patients was considered quite safe and effective both as the first and as a subsequent line of biologic treatment, especially in systemic patients. Because of the lack of head-to-head comparisons, a different profile of efficacy among IL-1 inhibitors could not be established. There was a large consensus that failure of the first IL-1 inhibitor does not preclude response to another one. The lack of studies comparing early versus late treatment did not allow to draw conclusions; however, data from SJIA suggest a better response in early treatment. CONCLUSIONS:The Delphi method was used to develop recommendations that we hope will help clinicians in the management of patients with AOSD refractory to conventional therapies.

Project description:PurposeHospital policies forbidding or limiting families from visiting relatives on the intensive care unit (ICU) has affected patients, families, healthcare professionals, and patient- and family-centered care (PFCC). We sought to refine evidence-informed consensus statements to guide the creation of ICU visitation policies during the current COVID-19 pandemic and future pandemics and to identify barriers and facilitators to their implementation and sustained uptake in Canadian ICUs.MethodsWe created consensus statements from 36 evidence-informed experiences (i.e., impacts on patients, families, healthcare professionals, and PFCC) and 63 evidence-informed strategies (i.e., ways to improve restricted visitation) identified during a modified Delphi process (described elsewhere). Over two half-day virtual meetings on 7 and 8 April 2021, 45 stakeholders (patients, families, researchers, clinicians, decision-makers) discussed and refined these consensus statements. Through qualitative descriptive content analysis, we evaluated the following points for 99 consensus statements: 1) their importance for improving restricted visitation policies; 2) suggested modifications to make them more applicable; and 3) facilitators and barriers to implementing these statements when creating ICU visitation policies.ResultsThrough discussion, participants identified three areas for improvement: 1) clarity, 2) accessibility, and 3) feasibility. Stakeholders identified several implementation facilitators (clear, flexible, succinct, and prioritized statements available in multiple modes), barriers (perceived lack of flexibility, lack of partnership between government and hospital, change fatigue), and ways to measure and monitor their use (e.g., family satisfaction, qualitative interviews).ConclusionsExisting guidance on policies that disallowed or restricted visitation in intensive care units were confusing, hard to operationalize, and often lacked supporting evidence. Prioritized, succinct, and clear consensus statements allowing for local adaptability are necessary to guide the creation of ICU visitation policies and to optimize PFCC.

Dataset Information

Consensus statements on vaccination in patients with haemophilia-Results from the Italian haemophilia and vaccinations (HEVA) project.

Publications

Consensus statements on vaccination in patients with haemophilia-Results from the Italian haemophilia and vaccinations (HEVA) project.

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