Development of a patient decision aid for COVID-19 vaccination with the Comirnaty vaccine.

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.

Impact of a health literacy intervention combining general practitioner training and a consumer facing intervention to improve colorectal cancer screening in underserved areas: protocol for a multicentric cluster randomized controlled trial.

BACKGROUND: Colorectal cancer (CRC) is a leading cause of cancer burden worldwide. In France, it is the second most common cause of cancer death after lung cancer. Systematic uptake of CRC screening can improve survival rates. However, people with limited health literacy (HL) and lower socioeconomic position rarely participate. Our aim is to assess the impact of an intervention combining HL and CRC screening training for general practitioners (GPs) with a pictorial brochure and video targeting eligible patients, to increase CRC screening and other secondary outcomes, after 1 year, in several underserved geographic areas in France. METHODS: We will use a two-arm multicentric randomized controlled cluster trial with 32 GPs primarily serving underserved populations across four regions in France with 1024 patients recruited. GPs practicing in underserved areas (identified using the European Deprivation Index) will be block-randomized to: 1) a combined intervention (HL and CRC training + brochure and video for eligible patients), or 2) usual care. Patients will be included if they are between 50 and 74 years old, eligible for CRC screening, and present to recruited GPs. The primary outcome is CRC screening uptake after 1 year. Secondary outcomes include increasing knowledge and patient activation. After trial recruitment, we will conduct semi-structured interviews with up to 24 GPs (up to 8 in each region) and up to 48 patients (6 to 12 per region) based on data saturation. We will explore strategies that promote the intervention's sustained use and rapid implementation using Normalization Process Theory. We will follow a community-based participatory research approach throughout the trial. For the analyses, we will adopt a regression framework for all quantitative data. We will also use exploratory mediation analyses. We will analyze all qualitative data using a framework analysis guided by Normalization Process Theory. DISCUSSION: Limited HL and its impact on the general population is a growing public health and policy challenge worldwide. It has received limited attention in France. A combined HL intervention could reduce disparities in CRC screening, increase screening rates among the most vulnerable populations, and increase knowledge and activation (beneficial in the context of repeated screening). TRIAL REGISTRATION: Registry: ClinicalTrials.gov. TRIAL REGISTRATION NUMBER: 2020-A01687-32 . Date of registration: 17th November 2020.

Construction of a patient decision aid for the treatment of uncomplicated urinary tract infection in primary care.

BACKGROUND: Uncomplicated urinary tract infection (uUTI) is very common among women in primary care. The risk of developing pyelonephritis remains low after uUTI, nonetheless, empiric antibiotic therapy is frequently prescribed for symptomatic purposes. This may lead to adverse effects and antibiotic resistance. Furthermore, patients may express the will to limit the use of antibiotics. Some European countries recommend discussing a delayed prescription with the patient and developing a shared decision. The aim of this study is to create a patient decision aid (PtDA) used in primary care settings to make a shared decision between practitioners and women about whether or not to treat uUTI with antibiotics. METHODS: We followed the steps recommended by the International Patient Decision Aids Standards, with a scoping phase, a design phase (including focus groups and literature review), and an alpha-testing phase. A steering group, made of patients and physicians, met throughout the study to develop a prototype PtDA. RESULTS: The information included in the PtDA is the definition of uUTI, information on the options, their benefits, risks, and consequences, based on a review of the literature. The results of the focus group made possible to determine the patient's values and preferences to consider in decision-making, including: the discomfort felt, the impact on daily life, patients' perceptions of antibiotics, and the position relative to the risk of adverse effect. The choices in presentation, organisation and design are the result of the work of the steering group, improved by feedback from alpha testing. We confirmed the need for shared decision-making and the equipoise in this situation. CONCLUSIONS: We developed a PtDA to be used in primary care for sharing decision on the use of antibiotic in uUTI. It needs to be validated in a beta-testing phase, with complementary advice from peers, and then tested in a clinical study comparing its use with the systematic prescription approach.

Perceived impact of discussions with a healthcare professional on patients' decision regarding COVID-19 vaccine.

There is evidence that advice from Healthcare Professionals (HCPs) plays an important role in patients' decision to get vaccinated, but the extent to which patients perceive this impact is unclear. The aim of this study was to assess the perceived impact of a discussion with a HCP on participants' decision to be vaccinated against COVID-19. A cross-sectional survey was conducted among adults who consulted a general practitioner (GP) or a pharmacist in Ile-de-France, France, after COVID-19 vaccines became available (October-November 2021 period). A total of 344 participants were included, 65.2% of whom reported having had a discussion about COVID-19 vaccines with a HCP. Overall, 55% of participants were advised to be vaccinated by their HCP. Most of the discussions took place with a GP (n = 203, 48.9%). According to 52.5% of participants, the discussion had a positive impact, i.e. it was perceived as encouraging vaccination. The latter reported that, among HCPs, GPs had the greatest number of discussions with a positive impact on the decision to be vaccinated against COVID-19 (93.1%). In the study population, the COVID-19 vaccine hesitancy rate, according to the WHO definition, was high (38.1%), although the COVID-19 vaccine coverage rate was 87.1%. Vaccine hesitant participants were more likely to report a discussion that had a perceived negative impact on their decision to get vaccinated (20.0%) than non-hesitant participants (5.8%, p = .004).

[Health issues in precarious people]. / Particularités des questions de santé chez les sujets en situation de précarité.

Health issues in precarious people. Though if it is not possible to draw a single picture of the health of precarious people, many works on social inequalities in health underline their vulnerability and an increased frequency of a variety health problems. We can cite certain harmful behaviors for health (smoking, consumption of psychoactive substances, insufficient food or, conversely, too rich and not very diversified, sedentary lifestyle, delay in screening and prevention, violence, etc...), for certain diseases (cardiovascular diseases, skin diseases, dental problems, respiratory diseases, mental distress, infectious diseases including tuberculosis and HIV, etc.) and in terms of access to care and prevention. Thus, despite the resources to reduce social inequalities in health in France, the state of health of people in precarious situations continues to deteriorate and should constitute a public health priority for health authorities and for caregivers.

Particularités des questions de santé chez les sujets en situation de précarité. Même s'il n'est pas possible de généraliser ni de dresser un tableau unique de l'état de santé des personnes en situation de précarité, de nombreux travaux sur les inégalités sociales de santé soulignent leur vulnérabilité et une fréquence augmentée d'une variété de problèmes de santé. C'est le cas pour certains comportements délétères pour la santé (tabagisme, consommation de substances psychoactives, alimentation insuffisante ou, à l'inverse, trop riche et peu diversifiée, sédentarité, non-recours aux dépistages et à la prévention, violences subies, etc.), pour certaines maladies (maladies cardiovasculaires, dermatoses, problèmes dentaires, pathologies respiratoires, la souffrance psychique, les maladies infectieuses dont la tuberculose et l'infection par le VIH, etc.) et en termes d'accès et de recours aux soins et à la prévention. Ainsi, malgré la mobilisation de moyens pour réduire les inégalités sociales de santé en France, l'état de santé des personnes en situation de précarité continue de se dégrader et devrait constituer une priorité de santé publique pour les autorités de santé et pour les soignants.