Development of a patient decision aid for COVID-19 vaccination with the Comirnaty vaccine.
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ABSTRACT: Background
SARS-CoV-2 has been responsible for a pandemic since the beginning of 2020. Vaccine arrival brings a concrete solution to fight the virus. However, vaccine hesitancy is high. In France, the first available vaccine was Comirnaty from Pfizer-BioNTech. Shared decision-making, based on tools such as patient decision aids (PtDAs), can help patients make an informed choice about vaccination with Comirnaty.Objective
The French College of Teachers in General Practice (CNGE) aimed to create a PtDA for people who have to decide whether they will receive the Comirnaty vaccine.Methods
Development of the PtDA was performed according to the International Patient Decision Aids Standards (IPDAS). The initial design was based on a literature review and semistructured interviews with 17 patients to explore and clarify patients' expectations. A first draft of the PtDA was then alpha tested by a patient expert group and a physician expert group. The PtDA was finally beta tested in 14 prevaccine consultations. A steering group was consulted throughout the work. Patient support, community groups and the French National Authority for Health (HAS) were involved in the development process.Results
A literature review identified one randomized trial on Comirnaty efficacy and safety. The first part of the PtDA allows patients to identify their own risk factors. The second part of the PtDA provides information on vaccination: benefits and risks, unknown data, and technical explanations about the mRNA vaccine.Conclusions
We developed a PtDA to be used in primary care settings for shared decision-making regarding vaccination with Comirnaty.
SUBMITTER: Vincent YM
PROVIDER: S-EPMC8690143 | biostudies-literature |
REPOSITORIES: biostudies-literature
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| S-EPMC8233960 | biostudies-literature
Project description:BackgroundWith a number of vaccines against COVID-19 now widely available globally, it is opportune to determine what tips the decision to get vaccinated. In most countries like the Philippines where the government provides these vaccines for free to all its citizens, their COVID-19 vaccine awareness and COVID-19 information sources as well as their socio-demographic profile were considered as primary factors that could possibly affect vaccination decisions. Participants' income level was considered as a possible financial consideration that can affect vaccination decision as transport to vaccination sites might entail costs to them.MethodsThis study used a cross sectional survey design wherein participants came from all regions of the Philippines. An online questionnaire was voluntarily answered by Filipinos aged 18-80 years of age.ResultsA total of 2,268 participated in the survey with 1,462 having complete responses which were included in the analysis. Those who are younger, with higher educational attainment, with public health insurance, with employers requiring vaccination, high awareness about COVID-19 vaccination, and high vaccine confidence are more likely to get vaccinated. On the other hand, those with long-standing illness and those residing outside the national capital region are less likely to get vaccinated.ConclusionVaccination decisions among Filipinos are determined by their age, educational attainment, health insurance, employer requirement, high awareness of the disease, and a high level of vaccine confidence.
| S-EPMC10170431 | biostudies-literature
Project description:IntroductionDifferent subtypes of vaccines have been developed to help protect populations from COVID-19. Currently, three vaccines have been authorized by the United States Food and Drug Administration for emergency use to combat the COVID-19 pandemic. With COVID-19 vaccination rates increasing, it is important to know whether immunodeficient patients have the capacity to mount an immune response with the available vaccines.Case reportA 78-year-old female with Common Variable Immunodeficiency and anti-IgA antibodies who is naïve to IVIgG treatment responded positively to a COVID-19 mRNA vaccine. Successful seroconversion was proved by having positive COVID-19 spike protein IgG antibodies weeks after the vaccination. Her recent IgG, IgA, and IgM levels were all significantly reduced. Previously, she had no response to the polysaccharide pneumococcal vaccine, but did maintain titers afterTdap vaccination.DiscussionImmunodeficient patients are a susceptible population during a pandemic. Unfortunately, there is a paucity of research on the infectivity, vaccination, and outcome of these patients during the COVID-19 outbreak. Our patient with CVID was able to respond to protein/toxoid vaccines, but did not respond to polysaccharide pneumococcal vaccine. After inoculation with an mRNA COVID-19 vaccine she was able to create COVID-19 spike protein IgG antibodies.ConclusionWe present a case of successful vaccination to COVID-19 by an mRNA vaccine in an IVIgG naïve CVID patient.
| S-EPMC8514739 | biostudies-literature
Project description:In the last two years, the coronavirus disease 19 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been a scientific and social challenge worldwide. Vaccines have been the most effective intervention for reducing virus transmission and disease severity. However, virus genetic variants are still circulating among vaccinated individuals with different symptomatology disease cases. Understanding the protective or disease associated mechanisms in vaccinated individuals is relevant to advance in vaccine development and implementation. To address this objective, serum protein profiles were characterized by quantitative proteomics and data analysis algorithms in four cohorts of vaccinated individuals uninfected and SARS-CoV-2 infected with asymptomatic, nonsevere and severe disease symptomatology. The results showed that immunoglobulins were the most overrepresented proteins in infected cohorts when compared to PCR-negative individuals. The immunoglobulin profile varied between different infected cohorts and correlated with protective or disease associated capacity. Overrepresented immunoglobulins in PCR-positive individuals correlated with protective response against SARS-CoV-2, other viruses, and thrombosis in asymptomatic cases. In nonsevere cases, correlates of protection against SARS-CoV-2 and HBV together with risk of myasthenia gravis and allergy and autoantibodies were observed. Patients with severe symptoms presented risk for allergy, chronic idiopathic thrombocytopenic purpura, and autoantibodies. The analysis of underrepresented immunoglobulins in PCR-positive compared to PCR-negative individuals identified vaccine-induced protective epitopes in various coronavirus proteins including the Spike receptor-binding domain RBD. Non-immunoglobulin proteins were associated with COVID-19 symptoms and biological processes. These results evidence host-associated differences in response to vaccination and the possibility of improving vaccine efficacy against SARS-CoV-2.
2022-10-14 | PXD031969 | Pride
Project description:Background Coronavirus disease-19 (COVID-19) due to acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is the largest emergency that humanity had to be dealing with in the last century. During the last months, different types of vaccines have been designed to contain the ongoing SARS-CoV-2 pandemic, with successful results in many countries. Comirnaty (Pfizer/BioNtech) COVID-19 vaccine is a lipid nanoparticle-formulated, nucleoside mRNA vaccine encoding the prefusion spike glycoprotein of SARS-CoV-2. Although vaccines have an undeniable efficacy, they can also present several neurological side effects, including headache. According to ICHD-3 Classification, status migrainosus (SMg) is described as a debilitating migraine attack lasting for more than 72 h. Symptoms of SMg can be very severe, preventing the normal daily activities of the individual. Case presentation In the present report, we describe a case of SMg that lasted 11 days, time correlated with the second dose of COVID-19 vaccine (Pfizer/Comirnaty) in a 37-year-old woman with a history of migraine without aura. Conclusions In patients with a history of migraine, COVID-19 vaccination could lead to a worsening of headache and, in rare cases, to the development of a SMg. This may be related to the inflammatory response that occurs after vaccination. Supplementary Information The online version contains supplementary material available at 10.1007/s10072-021-05741-x.
| S-EPMC8607053 | biostudies-literature
Project description:The SARS-CoV-2 Delta (B.1.617.2) variant is capable of infecting vaccinated persons. An open question remains as to whether deficiencies in specific vaccine-elicited immune responses result in susceptibility to vaccine breakthrough infection. We investigated 55 vaccine breakthrough infection cases (mostly Delta) in Singapore, comparing them against 86 vaccinated close contacts who did not contract infection. Vaccine breakthrough cases showed lower memory B cell frequencies against SARS-CoV-2 receptor binding domain (RBD). Compared to plasma antibodies, antibodies secreted by memory B cells retained a higher fraction of neutralizing properties against the Delta variant. Inflammatory cytokines including IL-1β and TNF were lower in vaccine breakthrough infections than primary infection of similar disease severity, underscoring the usefulness of vaccination in preventing inflammation. This report highlights the importance of memory B cells against vaccine breakthrough, and suggests that lower memory B cell levels may be a correlate of risk for Delta vaccine breakthrough infection.
| S-SCDT-EMM-2021-15227 | biostudies-other
Project description:BackgroundPatient decision aids (PtDAs) support patients and clinicians in shared decision-making (SDM). Real-world outcome information may improve patients' risk perception, and help patients make decisions congruent with their expectations and values. Our aim was to develop an online PtDA to support kidney failure treatment modality decision-making, that: 1) provides patients with real-world outcome information, and 2) facilitates SDM in clinical practice.MethodsThe International Patient Decision Aids Standards (IPDAS) development process model was complemented with a user-centred and convergent mixed-methods approach. Rapid prototyping was used to develop the PtDA with a multidisciplinary steering group in an iterative process of co-creation. The results of an exploratory evidence review and a needs-assessment among patients, caregivers, and clinicians were used to develop the PtDA. Seven Dutch teaching hospitals and two national Dutch outcome registries provided real-world data on selected outcomes for all kidney failure treatment modalities. Alpha and beta testing were performed to assess the prototype and finalise development. An implementation strategy was developed to guide implementation of the PtDA in clinical practice.ResultsThe 'Kidney Failure Decision Aid' consists of three components designed to help patients and clinicians engage in SDM: 1) a paper hand-out sheet, 2) an interactive website, and 3) a personal summary sheet. A 'patients-like-me' infographic was developed to visualise survival probabilities for each treatment modality on the website. Other treatment outcomes were incorporated as event rates (e.g. hospitalisation rates) or explained in text (e.g. the flexibility of each treatment modality). No major revisions were needed after alpha and beta testing. During beta testing, some patients ignored the survival probabilities because they considered these too confronting. Nonetheless, patients agreed that every patient has the right to choose whether they want to view this information. Patients and clinicians believed that the PtDA would help patients make informed decisions, and that it would support values- and preferences-based decision-making. Implementation of the PtDA has started in October 2020.ConclusionsThe 'Kidney Failure Decision Aid' was designed to facilitate SDM in clinical practice and contains real-world outcome information on all kidney failure treatment modalities. It is currently being investigated for its effects on SDM in a clinical trial.
| S-EPMC9257566 | biostudies-literature
Project description:ObjectivesThe immunogenicity of the Comirnaty® vaccine against coronavirus disease 2019 (COVID-19) has not been adequately studied in elderly people with comorbidities. We assessed antibody and T-cell responses targeted to the S protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) following full vaccination in nursing-home residents.MethodsSixty nursing-home residents (44 female, age 53-100 years), of whom ten had previously been diagnosed with COVID-19, and 18 healthy controls (15 female, age 27-54 years) were recruited. Pre- and post-vaccination blood specimens were available for quantification of total antibodies binding the SARS-CoV-2 S protein and for enumeration of SARS-CoV-2 S-reactive IFN-γ CD4+ and CD8+ T cells by flow cytometry.ResultsThe seroconversion rate in (presumably) SARS-CoV-2-naïve nursing-home residents (41/43, 95.3%) was similar to that in controls (17/18, 94.4%). A booster effect was documented in post-vaccination samples of nursing-home residents with prior COVID-19. Plasma antibody levels were higher (p < 0.01) in recovered nursing-home residents (all 2500 IU/mL) than in individuals across the other two groups (median 1120 IU/mL in naïve nursing-home residents and 2211 IU/ml in controls). A large percentage of nursing-home residents had SARS-CoV-2 S-reactive IFN-γ CD8+ (naïve 31/49, 63.2%; recovered 8/10, 80%) or CD4+ T cells (naïve 35/49, 71.4%; recovered 7/10, 70%) at baseline, in contrast to healthy controls (3/17, 17.6% and 5/17, 29%, respectively). SARS-CoV-2 IFN-γ CD8+ and CD4+ T-cell responses were documented in 88% (15/17) and all control subjects after vaccination, respectively, but only in 65.5% (38/58) and 22.4% (13/58) of nursing-home residents. Overall, the median frequency of SARS-CoV-2 IFN-γ CD8+ and CD4+ T cells in nursing-home residents decreased in post-vaccination specimens, whereas it increased in controls.ConclusionThe Comirnaty COVID-19 vaccine elicits robust SARS-CoV-2 S antibody responses in nursing-home residents. Nevertheless, the rate and frequency of detectable SARS-CoV-2 IFN-γ T-cell responses after vaccination was lower in nursing-home residents than in controls.
| S-EPMC8223011 | biostudies-literature
Project description:BACKGROUND:An individualized approach using shared decision-making (SDM) and goal setting is a person-centred strategy that may facilitate prioritization of treatment options. SDM has not been adopted extensively in clinical practice. An interprofessional approach to SDM with tools to facilitate patient participation may overcome barriers to SDM use. The aim was to explore decision-making experiences of health professionals and people with diabetes (PwD), then develop an intervention to facilitate interprofessional shared decision-making (IP-SDM) and goal-setting. METHODS:This was a multi-phased study. 1) Feasibility: Using a descriptive qualitative study, individual interviews with primary care physicians, nurses, dietitians, pharmacists, and PwD were conducted. The interviews explored their experiences with SDM and priority-setting, including facilitators and barriers, relevance of a decision aid for priority-setting, and integration of SDM and a decision aid into practice. 2) Development: An evidence-based SDM toolkit was developed, consisting of an online decision aid, MyDiabetesPlan, and implementation tools. MyDiabetesPlan was reviewed by content experts for accuracy and comprehensiveness. Usability assessment was done with 3) heuristic evaluation and 4) user testing, followed by 5) refinement. RESULTS:Seven PwD and 10 clinicians participated in the interviews. From interviews with PwD, we identified that: (1) approaches to decision-making were diverse and dynamic; (2) a trusting relationship with the clinician and dialog were critical precursors to SDM; and, (3) goal-setting was a dynamic process. From clinicians, we found: (1) complementary (holistic and disease specific) approaches to the complex patient were used; (2) patient-provider agendas for goal-setting were often conflicting; (3) a flexible approach to decision-making was needed; and, (4) conflict could be resolved through SDM. Following usability assessment, we redesigned MyDiabetesPlan to consist of data collection and recommendation stages. Findings were used to finalize a multi-component toolkit and implementation strategy, consisting of MyDiabetesPlan, instructional card and videos, and orientation meetings with participating patients and clinicians. CONCLUSIONS:A decision aid can provide information, facilitate clinician-patient dialog and strengthen the therapeutic relationship. Implementation of the decision aid can fit into a model of team care that respects and exemplifies professional identity, and can facilitate intra-team communication. TRIAL REGISTRATION:Clinicaltrials.gov Identifier: NCT02379078. Date of Registration: 11 February 2015.
| S-EPMC6749701 | biostudies-literature
Project description:BackgroundGout treatment is not optimized globally, often due to therapeutic inertia by physicians or poor adherence to urate-lowering medications by patients. A patient decision aid (PDA) to facilitate shared decision making (SDM) in gout treatment may overcome these physician-patient barriers.ObjectiveThe study explored the views of physicians and patients on a novel locally designed gout treatment PDA prototype.DesignQualitative descriptive design was used to gather data from in-depth-interviews (IDI) and focus group discussions (FGD). Data analysis was via thematic analysis. Emergent themes shaped a revised version of the PDA.Setting and participantsAdult Asian patients with recent acute gout exacerbations and local Primary Care Physicians (PCP) in Singapore were purposefully chosen. 15 patients with gout and 11 PCPs participated across three IDIs and six FGDs, with the investigators exploring their views of a prototype gout treatment PDA.ResultsPatients and physicians generally concurred with the content and design of the PDA prototype. However, while patients preferred fewer treatment details, the PCPs desired more information. Patients preferred the display of statistics, while PCPs felt that numbers were not relevant to patients. The latter were hesitant to include treatment options that were unavailable in primary care. Both stakeholders indicated that they would use the PDA during a consultation. PCPs would need further training in SDM, given a lack of understanding of it.Conclusion and patient contributionPatients will be the prime users of the PDA. While their views differed partially from the physicians, both have jointly developed the novel gout treatment PDA.
| S-EPMC8077153 | biostudies-literature