Proposal for a shared definition of « primary healthcare ¼ by health professionals: A national cross-sectional survey.

INTRODUCTION: Forty years passed between the two most important definitions of primary health care from Alma Alta Conference in 1978 to WHO's definition in 2018. Since then, reforms of healthcare systems, changes in ambulatory sector and COVID 19, have created a need for reinterpretations and redefinition of primary healthcare. The primary objective of the study was to precise the definitions and the representations of primary healthcare by healthcare professionals. METHODS: We conducted a descriptive cross-sectional study using a web-based anonymized questionnaire including opened-ended and closed-ended questions but also "real-life" case-vignettes to assess participant's perception of primary healthcare, from September to December 2020. Five case-vignette, describing situations involving a specific primary health care professional in a particular place for a determined task were selected, before the study, by test/retest method. RESULTS: A total of 585 healthcare practitioners were included in the study, 29% were general practitioners and 32% were midwives. Amongst proposed healthcare professions, general practitioners (97.6%), nurses (85.3%), midwives (85.2%) and pharmacists (79.3%) were those most associated with primary healthcare. The functions most associated with primary healthcare, with over 90% of approval were "prevention, screening", "education to good health", "orientation in health system". Two case-vignettes strongly emerged as describing a situation of primary healthcare: Midwife/Hospital/Pregnancy (74%) and Pharmacist/Pharmacy/Flu shot (90%). The profession and the modality of practice of the responders lead to diverging answers regarding their primary healthcare representations. CONCLUSIONS: Primary healthcare is an ever-evolving part of the healthcare system, as is its definition. This study explored the perception of primary healthcare by French healthcare practitioners in two complementary ways: oriented way for the important functions and more practical way with the case-vignettes. Understanding their differences of representation, according to their profession and practice offered the authors a first step to a shared and operational version of the primary healthcare definition.

A national platform for Covid-19 vaccine studies recruitment in France: Covireivac volunteer's characteristics.

During the Covid-19 pandemic, the urgent need for safe and effective vaccines has led to many vaccine trials, implying fast and extensive recruitment of volunteers. In France, until 2020, vaccine clinical research participants were usually recruited locally, through center-based pools of volunteers, and local communication plans. Covireivac is a French public online platform launched on 10/01/2020 that enables national, large-scale recruitment of volunteers for Covid-19 vaccine studies. On the Covireivac website, all adult participants registered online, gave their informed consent, and filled out two online forms with information on their identity, health status (comorbidities, treatments), and known exposure to SARS-CoV-2. Since July 2021, volunteers could mention if their children are interested in participating in a Covid-19 vaccine trial. The objective of this work is to describe Covireivac's volunteer characteristics registered from 10/01/2020 to 11/02/2022. To identify independent volunteer characteristics associated with a period of registration we performed a multivariate logistic regression. Among 54,424 registrations, 52,391 (96%) were analysed; 61% were male (n = 31,893), median age was 50 y; 13% (n = 6586) were healthcare workers. At registration, 15,879 volunteers (33%) reported at least one comorbidity, among whom 16% (n = 7349) were obese and 17% (n = 8346) had hypertension. Most volunteers registered during the first month (n = 35,876, 66%). The Covireivac platform allowed quick and large recruitment of potential volunteers for Covid-19 vaccine trials and could be used on a larger scale for vaccine trials in France. It could facilitate recruitment in vaccine trials and provide sponsors with better visibility of the recruitment capacities of clinical research centers.

Impact of a phone call with a medical student/general practitioner team on morbidity of chronic patients during the first French COVID-19 lockdown (COVIQuest): a cluster randomised trial.

OBJECTIVES: The first COVID-19 lockdown led to a significantly reduced access to healthcare, which may have increased decompensations in frail patients with chronic diseases, especially older patients living with a chronic cardiovascular disease (CVD) or a mental health disorder (MHD). The objective of COVIQuest was to evaluate whether a general practitioner (GP)-initiated phone call to patients with CVD and MHD during the COVID-19 lockdown could reduce the number of hospitalisation(s) over a 1-month period. DESIGN: This is a cluster randomised controlled trial. Clusters were GPs from eight French regions. PARTICIPANTS: Patients ≥70 years old with chronic CVD (COVIQuest_CV subtrial) or ≥18 years old with MHD (COVIQuest_MH subtrial). INTERVENTIONS: A standardised GP-initiated phone call aiming to evaluate patients' need for urgent healthcare, with a control group benefiting from usual care (ie, the contact with the GP was by the patient's initiative). MAIN OUTCOME MEASURES: Hospital admission within 1 month after the phone call. RESULTS: In the COVIQuest_CV subtrial, 131 GPs and 1834 patients were included in the intervention group and 136 GPs and 1510 patients were allocated to the control group. Overall, 65 (3.54%) patients were hospitalised in the intervention group vs 69 (4.57%) in the control group (OR 0.82, 95% CI 0.56 to 1.20; risk difference -0.77, 95% CI -2.28 to 0.74). In the COVIQuest_MH subtrial, 136 GPs and 832 patients were included in the intervention group and 131 GPs and 548 patients were allocated to the control group. Overall, 27 (3.25%) patients were hospitalised in the intervention group vs 12 (2.19%) in the control group (OR 1.52, 95% CI 0.82 to 2.81; risk difference 1.38, 95% CI 0.06 to 2.70). CONCLUSION: A GP-initiated phone call may have been associated with more hospitalisations within 1 month for patients with MHD, but results lack robustness and significance depending on the statistical approach used. TRIAL REGISTRATION NUMBER: NCT04359875.

No association of low-dose aspirin with severe COVID-19 in France: A cohort of 31.1 million people without cardiovascular disease.

Background: Aspirin at low doses has been reported to be a potential drug candidate to treat or prevent severe coronavirus disease 2019 (COVID-19). Objectives: We aimed to explore whether low-dose aspirin used for primary cardiovascular prevention was associated with a lower risk of severe COVID-19. Method: A large cohort of patients without known cardiovascular comorbidities was constructed from the entire French population registered in national health care databases. In total, 31.1 million patients aged ≥40 years, including 1.5 million reimbursed for low-dose aspirin at least at three time points during the 6 months before the epidemic, were followed until hospitalization with a COVID-19 diagnosis or intubation/death for hospitalized patients. Results: Cox models adjusted for age and sex showed a positive association between low-dose aspirin and the risk of hospitalization (hazard ratio [HR], 1.33; 95% confidence interval (CI), 1.29-1.37]) or death/intubation (HR, 1.40 [95% CI, 1.33-1.47]). In fully adjusted models, associations were close to null (HR, 1.03 [95% CI, 1.00-1.06] and 1.04 [95% CI, 0.98-1.10], respectively). Conclusion: There was no evidence for an effect of low-dose aspirin for primary cardiovascular prevention in reducing severe COVID-19.

Inhaled ciclesonide for outpatient treatment of COVID-19 in adults at risk of adverse outcomes: a randomised controlled trial (COVERAGE).

OBJECTIVES: To assess the efficacy of inhaled ciclesonide in reducing the risk of adverse outcomes in COVID-19 outpatients at risk of developing severe illness. METHODS: COVERAGE is an open-label, randomized controlled trial. Outpatients with documented COVID-19, risk factors for aggravation, symptoms for ≤7 days, and absence of criteria for hospitalization are randomly allocated to either a control arm or one of several experimental arms, including inhaled ciclesonide. The primary efficacy endpoint is COVID-19 worsening (hospitalization, oxygen therapy at home, or death) by Day 14. Other endpoints are adverse events, maximal follow-up score on the WHO Ordinal Scale for Clinical Improvement, sustained alleviation of symptoms, cure, and RT-PCR and blood parameter evolution at Day 7. The trial's Safety Monitoring Board reviewed the first interim analysis of the ciclesonide arm and recommended halting it for futility. The results of this analysis are reported here. RESULTS: The analysis involved 217 participants (control 107, ciclesonide 110), including 111 women and 106 men. Their median age was 63 years (interquartile range 59-68), and 157 of 217 (72.4%) had at least one comorbidity. The median time since first symptom was 4 days (interquartile range 3-5). During the 28-day follow-up, 2 participants died (control 2/107 [1.9%], ciclesonide 0), 4 received oxygen therapy at home and were not hospitalized (control 2/107 [1.9%], ciclesonide 2/110 [1.8%]), and 24 were hospitalized (control 10/107 [9.3%], ciclesonide 14/110 [12.7%]). In intent-to-treat analysis of observed data, 26 participants reached the composite primary endpoint by Day 14, including 12 of 106 (11.3%, 95% CI: 6.0%-18.9%) in the control arm and 14 of 106 (13.2%; 95% CI: 7.4-21.2%) in the ciclesonide arm. Secondary outcomes were similar for both arms. DISCUSSION: Our findings are consistent with the European Medicines Agency's COVID-19 task force statement that there is currently insufficient evidence that inhaled corticosteroids are beneficial for patients with COVID-19.

Adaptation of independent midwives to the COVID-19 pandemic: A national descriptive survey.

OBJECTIVE: The main objective of this survey was to identify how independent midwives, mainly working in primary care, adapted their practices at the beginning of the COVID-19 pandemic in France. Our assumption was that this practice adaptation would vary according to both geographical area (timing of pandemic effect) and whether they practiced alone or in a group. DESIGN: We conducted an online national survey of independent midwives in France from March 16-23, 2020. SETTING: All districts in mainland France and the overseas territories. PARTICIPANTS: Respondents from the population of all independent midwives working in France. MEASUREMENTS AND FINDINGS: The primary outcome measure was the proportion of midwives reporting that they had adapted their practices to the context of the COVID-19 pandemic, and the rank, in order of frequency, of the postponed or cancelled activities. RESULTS: Of the 1517 midwives who responded, i.e., 20.3% of the independent midwives in France, 90.6% reported adapting one or more of their practices . The main adjustment was the postponement or cancellation of consultations deemed non-essential, listed in descending order: postpartum pelvic floor rehabilitation (n = 1270, 83.7%), birth preparation (n = 1188, 78.3%), non-emergency preventive gynaecology consultation (n = 976, 64.3%), early prenatal interview (n = 170, 11.2%), and postnatal follow-up (n = 158, 10.4%). KEY CONCLUSIONS: Without guidelines, each midwife had to decide individually if and how to adapt her practice. Postpartum pelvic floor rehabilitation and birth preparation have been strongly affected. The results of this national survey indicate that a large majority of midwives have adapted their practices, independently of the local course of the pandemic, and that this reduction of contacts with women raises questions in this period of anxiety about intermediate-term adaptations to guarantee the continuity and safety of care. IMPLICATIONS FOR PRACTICE: This study's results can be used to develop tools to handle cancelled consultations. Video, also called virtual, visits and coordination between independent practitioners and hospitals are probably the major challenges in the current context.

How GPs adapted their practices and organisations at the beginning of COVID-19 outbreak: a French national observational survey.

OBJECTIVES: To describe how general practitioners (GPs) adapted their practices to secure and maintain access to care in the epidemic phase. A secondary objective was to explore if GPs' individual characteristics and type of practice determined their adaptation. DESIGN: Observational study using an online questionnaire. Organisational changes were measured by a main question and detailed in two specific outcomes. To identify which GPs' characteristics impacted organisational changes, successive multivariate logistic modelling was performed. First, we identified the GPs' characteristics related to organisational changes with a univariate analysis. Then, we tested the adjusted associations between this variable and the following GPs' characteristics: age, gender and type of practice. SETTING: The questionnaire was administered online between 14 March and 21 March 2020. Practitioners were recruited by email using the contact lists of different French scientific GP societies. PARTICIPANTS: The target population was GPs currently practising in France (n=46 056). We obtained a total of 7481 responses. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome: Proportion of GPs who adapted their practice. Secondary outcome: GPs' characteristics related to organisational changes. RESULTS: Among the 7481 responses, 5425 were complete and were analysed. 3849 GPs (70.9%) changed their activity, 3605 GPs (66.5%) increased remote consultations and 2315 GPs (42.7%) created a specific pathway for probable patients with COVID-19. Among the 3849 GPs (70.9%) who changed their practice, 3306 (91.7%) gave more answers by phone, 996 (27.6%) by email and 1105 (30.7%) increased the use of video consultations. GPs working in multi-professional group practices were more likely to have changed their activity since the beginning of the epidemic wave than GPs working in mono-professional group or single medical practices (adjusted OR: 1.32, 95% CI 1.12 to 1.56, p=0.001). CONCLUSIONS: French GPs adapted their practices regarding access to care for patients in the context of the COVID-19 epidemic. This adaptation was higher in multi-professional group practices.