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Introduction: A better understanding of the determinants involved in general practitioners' (GPs) decision-making processes when it comes to prescribing statins as primary prevention in patients with multimorbidity could provide insights for improving implementation of primary prevention guidelines., Methods: We conducted a qualitative study using a deductive framework-based and inductive analysis of GPs' semi-structured interviews verbatim, from which expertise profiles of prescribers were also drawn. The analytical framework was built from a pragmatic synthesis of the evidence-based medicine, Modelling using Typified Objects (MOT) model of clinical reasoning processes, Theoretical Domains Framework, and shared decision-making frameworks., Results: Fifteen GPs were interviewed between June 2019 and January 2020. Diabetes seemed to represent a specific motivation for deciding about statin prescription for primary prevention purposes; and in situations of multimorbidity, GPs differentiated between cardiovascular and non-cardiovascular multimorbidity. Expert prescribers seemed to have integrated the utilisation of cardiovascular risk calculation scores throughout their practice, whereas non-expert prescribers considered them difficult to interpret and preferred using more of a "rule of thumb" process. One interviewee used the risk calculation score as a support for discussing statin prescription with the patient., Conclusion: Our results shed light on the reasons why statins remain under-prescribed for primary prevention and why non-diabetic multimorbid patients have even lower odds of being prescribed a statin. They call for a change in the use of risk assessment scores, by placing them as decision aids, to support and improve personalised shared decision-making discussions as an efficient approach to improve the implementation of recommendations about statins for primary prevention., (© The Author(s) 2023. Published by Oxford University Press.)

Background: Statins are a first line, evidence-based yet underprescribed treatment for cardiovascular primary prevention. In primary care settings, multimorbidity is a complex situation which makes it difficult to apply prevention guidelines., Aim: To assess the associations between multimorbidity and prescription of statins in accordance with the 2016 ESC recommendations ("appropriate prescription"), and to identify the factors and conditions associated with these prescriptions., Design and Setting: Cross-sectional prospective study in the French region of Rhône-Alpes among 40 general practitioners and their patients., Methods: We examined the association between appropriate statin prescription and several patient characteristics, including multimorbidity, using multivariate logistic regression models., Results: Between August 2017 and February 2019, 327 patients were included in the study. Seventy-four (22.6%) were on statin medication and 199 (60.9%) exhibited multimorbidity, defined as ≥2 diseases. Only 22.5% of eligible patients were prescribed statins for primary prevention. Diabetes was most strongly associated with appropriate statin prescription (aOR 8.10, CI 95: 3.81-17.80). Multimorbidity was not associated with appropriate statin prescription (aOR 1.31, CI 95: 0.54-3.26), except in the presence of diabetes which defined diabetic multimorbidity (aOR 10.46, CI 95: 4.87-23.35). Conversely, non-diabetic multimorbidity was associated with lower odds of being appropriately prescribed a statin (aOR 0.26, CI 95: 0.12-0.56)., Conclusion: Multimorbidity, in itself, does not seem to be a determinant factor for appropriate statin prescription. The latter appears to be determined by a patient's type of multimorbidity, especially the presence or not of diabetes. Differentiating between diabetic and non-diabetic multimorbidity may be a pragmatic way for GPs to improve primary prevention in a patient-centered and shared decision-making approach., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Onaisi, Dumont, Hasselgard-Rowe, Safar, Haller and Maisonneuve.)

Background: The emergency set-up and implementation of outpatient clinical trials on epidemic emerging infectious diseases such as COVID-19 raise many issues in terms of research structuration, regulations, and health systems organization. We aimed to describe the experience and points of view of different stakeholders involved in a French home-based outpatient trial on COVID-19 and to identify the early barriers and facilitators to the trial implementation., Methods: We conducted a mixed-methods study in July 2020. A self-administered questionnaire was emailed to 213 clinical, operational and research stakeholders involved in the Coverage trial; individual semi-directed interviews were conducted among 14 stakeholders. Questionnaire data and written interview notes are presented together by key theme., Results: One hundred fifty six stakeholders responded to the questionnaire. 53.4% did not have prior experience in clinical research. The motivation of most stakeholders to participate in the Coverage trial was to feel useful during the pandemic. 87.9% agreed that the trial had an unusual set-up timeframe, and many regretted a certain lack of regulatory flexibility. Mobile medical teams and specific professional skills were perceived as instrumental for outpatient research., Conclusions: The implementation of a home-based outpatient clinical trial on COVID-19 was perceived as relevant and innovative although requiring important adaptations of usual professional responsibilities and standard research procedures. Lessons learned from the Coverage trial underline the need for improved networks between hospital and community medicine, and call for a dedicated and reactive outpatient research platform on emerging or threatening infectious diseases., (© 2022. The Author(s).)

Background: Sexually transmitted infections are a major public health issue, both in France and worldwide. Primary healthcare professionals play a key role in sexual health and prevention, but few take on this subject. Prevention strategies are diverse, thus risk reduction strategies focussing on behavioural changes are still needed., Purpose: We conducted a systematic review to analyse risk reduction interventions focussing on behavioural change in OECD countries in primary healthcare settings to help develop a prevention tool easy to apply in primary care., Methods: We searched for English- or French-language controlled trials in PubMed, Cochrane Library, Scopus, PsycINFO, PsycArticle, PBSC, SocINDEX, Google Scholar, and CAIRN, supplemented with the bibliographies of previous systematic reviews. Thirty controlled, randomized, or nonrandomized trials were included in the systematic review. We did not conduct any meta-analysis due to the diversity of populations, outcomes and study designs., Results: There are efficient interventions in primary healthcare settings for reducing sexual risk behaviours and/or incident STI. Their efficiency seems to grow with the length and intensity of the intervention. Most interventions target only young, high-risk patients, and their long-term impact is uncertain. Most included studies had an overall risk of bias estimated as high or with some concerns., Conclusions: Some tools could be used in primary care, with possible efficiency though results are difficult to generalize, and value should be assessed in daily practice. Future research should also focus on older population given the epidemiological evolutions, but also lower-risk population to target all patients seen in primary care settings., (© The Author(s) 2021. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

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., (Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.)