Effectiveness of a School- and Primary Care-Based HPV Vaccination Intervention: The PrevHPV Cluster Randomized Trial.

Importance: The human papillomavirus (HPV) vaccine is safe and effective, yet vaccination coverage remains below public health objectives in many countries. Objective: To examine the effectiveness of a 3-component intervention on HPV vaccination coverage among adolescents aged 11 to 14 years 2 months after the intervention ended, each component being applied alone or in combination. Design, Setting, and Participants: A cluster randomized trial with incomplete factorial design (PrevHPV) was conducted between July 1, 2021, and April 30, 2022, in French municipalities receiving 0, 1, 2, or 3 components of the intervention. Randomization was stratified by school district and municipalities' socioeconomic level. Analyses were carried out on 11- to 14-year-old adolescents living in all participating municipalities, regardless of what had been implemented. Intervention: The PrevHPV intervention had 3 components: (1) educating and motivating 11- to 14-year-old adolescents in middle schools, along with their parents; (2) training general practitioners (GPs) on up-to-date HPV information and motivational interviewing techniques; and (3) free HPV vaccination at school. Main Outcomes and Measures: The primary outcome was HPV vaccination coverage (≥1 dose) 2 months after the intervention ended among 11- to 14-year-old adolescents living in participating municipalities, based on the French national reimbursement database and data collected during the trial in groups randomized to implement at-school vaccination. Results: A total of 91 municipalities comprising 30 739 adolescents aged 11 to 14 years (15 876 boys and 14 863 girls) were included and analyzed. Half the municipalities were in the 2 lowest socioeconomic quintiles and access to GPs was poor in more than two-thirds of the municipalities. Thirty-eight of 61 schools (62.3%) implemented actions and 26 of 45 municipalities (57.8%) had at least 1 trained GP. The median vaccination coverage increased by 4.0 percentage points (IQR, 2.0-7.3 percentage points) to 14.2 percentage points (IQR, 9.1-17.3 percentage points) at 2 months. At-school vaccination significantly increased vaccination coverage (5.50 percentage points [95% CI, 3.13-7.88 percentage points]) while no effect was observed for adolescents' education and motivation (-0.08 percentage points [95% CI, -2.54 to 2.39 percentage points]) and GPs' training (-1.46 percentage points [95% CI, -3.44 to 0.53 percentage points]). Subgroup analyses found a significant interaction between at-school vaccination and access to GPs, with a higher effect when access was poor (8.62 percentage points [95% CI, 5.37-11.86 percentage points] vs 2.13 percentage points [95% CI, -1.25 to 5.50 percentage points]; P = .007 for interaction). Conclusions and Relevance: In this cluster randomized trial, within the context of the late COVID-19 pandemic period and limited school and GP participation, at-school HPV vaccination significantly increased vaccination coverage. The trial did not show a significant effect for training GPs and education and motivation, although it may be observed after more time has elapsed after the intervention. Trial Registration: ClinicalTrials.gov Identifier: NCT04945655.

Quality of Preanesthesia Teleconsultation: The TELECAM Randomized Controlled Trial.

Introduction: Preanesthesia teleconsultation helps reduce availability constraints as well as direct and indirect expenses. The TELECAM trial was performed to assess the quality of preanesthesia teleconsultation in terms of clinical parameters evaluation, feasibility, patient satisfaction and preoperative anxiety, and anesthesiologist satisfaction. Methods: TELECAM was an investigator-initiated, prospective, single-center, randomized, controlled, parallel group, evaluator-blinded, open-label study. Patients with a scheduled ambulatory surgery (orthopedic or hand surgery) were randomized into the in-person preanesthesia consultation group or the preanesthesia teleconsultation (conducted at the patient's home or workplace) group. The quality of the teleconsultation was evaluated through agreement on intubation difficulty, predictable mask ventilation difficulty, and American Society of Anesthesiologists (ASA) scores between the preanesthesia consultation and the preanesthesia in-person visit. Results: A total of 241 patients were included, and 208 were considered in the analyses. The feasibility of teleconsultation was high, with a feasibility ratio of 87.5%. The quality of the preanesthesia consultation regarding the evaluation of predictable intubation, mask ventilation difficulties, and ASA score, did not differ between the two groups (p = 0.23, 0.29, and 0.06, respectively). The preoperative satisfaction was higher for patients who had a preanesthesia teleconsultation (p = 0.04). Patients' preoperative anxiety did not differ between the two groups (p = 0.90). The median satisfaction of the anesthesiologists who performed the teleconsultation reached a maximum of 10 (IQR: 8.0; 10.0). Conclusion: This study showed positive results for the quality of preanesthesia teleconsultation on the evaluation of clinical parameters, with high feasibility and satisfaction of the patients and anesthesiologists. The trial was registered in ClinicalTrials (NCT03470896).

Optimizing Communication on HPV Vaccination to Parents of 11- to 14-Year-Old Adolescents in France: A Discrete Choice Experiment.

BACKGROUND: With the aim to optimize communication during HPV vaccination campaigns in France, we elicited parental preferences around HPV vaccination. METHODS: We conducted a single-profile discrete choice experiment (DCE) among parents of 11- to 14-year-old middle-school pupils, who completed an anonymous, self-administered, internet-based questionnaire during 2020-2021. The DCE comprised five attributes (vaccine-preventable disease, justification of optimal age, information on safety, indirect protection and coverage) of vaccination against an unnamed disease that were presented to respondents in ten choice tasks, or scenarios. We use fixed effect logit models to estimate attribute weights on theoretical vaccine acceptance, and random effect linear regression to estimate attribute coefficients on vaccine eagerness (decision and decision certainty). We estimated marginal effects of attributes on expected vaccine acceptance. RESULTS: Vaccination scenarios were accepted by 55.6-89.2% of the 1291 participants. The largest marginal effects on expected vaccine acceptance in the full sample arose from prevention of cancer versus genital warts (+ 11.3 percentage points); from a "severe side effect suspicion that was not scientifically confirmed" versus a statement about "more benefits than risks" (+ 8.9 percentage points), and information on 80% vaccine coverage in neighbouring countries versus on "insufficient coverage" (+ 4.2 percentage points). Explaining the early age of vaccination by sexual debut had a strong negative impact among French monolingual parents with lower education level (vs age-independent, OR 0.48, 95% CI 0.27-0.86), but not other socio-economic groups. After removing low-quality responses (unvaried certainty and short questionnaire completion), among serial non-demanders with children not vaccinated against HPV, only disease elimination impacted vaccine eagerness positively (coefficient 0.54, 0.06-1.02). DISCUSSION: Using DCEs to elicit parents' preferences around communication messages, notably on cancer prevention, vaccine coverage and information about vaccine safety, could help to optimize HPV vaccination promotion efforts.

Selection of proxy indicators estimating the appropriateness of antibiotic prescriptions in general practice: a national consensus procedure in France.

Background: GPs are responsible for more than 70% of outpatient antibiotic prescriptions in France. Metrics are important antibiotic stewardship tools that can be used to set targets for improvement and to give feedback to professionals and stakeholders. Objectives: The primary objective of the present study was to select a set of proxy indicators (PIs) based on 10 previously developed PIs, to estimate the appropriateness of antibiotic prescriptions by GPs. The secondary objective was to evaluate the clinimetric properties of the selected PIs. Methods: A RAND-modified Delphi consensus procedure was conducted with a multidisciplinary panel of stakeholders. This procedure consisted of two successive online surveys with a consensus meeting in between. Clinimetric properties (measurability, applicability and potential room for improvement) were evaluated for the PIs selected through the consensus procedure, using 2022 Regional Health Insurance data. Results: Seventeen experts participated in the first-round survey and 14 in the second-round. A final set of 12 PIs was selected. Among the 10 initial PIs, 3 were selected without modification and 7 were modified and selected. Moreover, two newly suggested PIs were selected. Ten of the 12 PIs presented good clinimetric properties. Conclusions: The 12 selected PIs cover the main situations responsible for inappropriate and unnecessary use of antibiotics in general practice. These PIs, easily calculable using routinely collected health insurance reimbursement data, might be used to give feedback to prescribers and stakeholders and help improve antibiotic prescriptions in primary care.

Perceptions of infection control professionals toward electronic surveillance software supporting inpatient infections: A mixed methods study.

BACKGROUND: Electronic surveillance software (ESS) collects multiple patient data from hospital software to assist infection control professionals in the prevention and control of hospital-associated infections. This study aimed to understand the perceptions of end users (i.e., infection control professionals) and the facilitators and barriers related to a commercial ESS named ZINC and to assess its usability. METHODS: A mixed-method research approach was adopted among infection control professionals 10 months after the implementation of commercial ESS in the university hospital of Nancy, France. A qualitative analysis based on individual semistructured interviews was conducted to collect professionals' perceptions of ESS and to understand barriers and facilitators. Qualitative data were systematically coded and thematically analyzed. A quantitative analysis was performed using the System Usability Scale (SUS). RESULTS: Thirteen infection control professionals were included. Qualitative analysis revealed technical, organizational and human barriers to the installation and use stages and five significant facilitators: the relevant design of the ESS, the improvement of infection prevention and control practices, the designation of a champion/superuser among professionals, training, and collaboration with the developer team. Quantitative analysis indicated that the evaluated ESS was a "good" system in terms of perceived ease of use, with an overall median SUS score of 85/100. CONCLUSIONS: This study shows the value of ESS to support inpatient infections as perceived by infection control professionals. It reveals barriers and facilitators to the implementation and adoption of ESS. These barriers and facilitators should be considered to facilitate the installation of the software in other hospitals.

Do boys have the same intentions to get the HPV vaccine as girls? Knowledge, attitudes, and intentions in France.

BACKGROUND: The vaccine coverage against human papillomavirus (HPV) vaccination remains low in France. The objective of this study was to study adolescent perceptions by comparing boys and girls, in order to build effective school-based interventions. METHODS: This paper presents a cross-sectional study in French middle school pupils. They completed online questionnaires on their knowledge and attitudes toward the HPV vaccine, HPV vaccination status, their intention, reasons to vaccinate or not to vaccinate, and psychological antecedents of vaccination. A structural equation modeling (SEM) analysis was used to test the hypothesized model. RESULTS: The participants are 818 pupils aged from 12 to 16 years (Mage = 13.78). Most pupils were in the pre-contemplative stage (62.7 % of boys and 40.8 % of girls). SEM analysis indicated that the relationship between the level of HPV knowledge, the representations of vaccines in general, and vaccine intention was mediated by attitudes towards the HPV vaccine among both boys and girls. CONCLUSIONS: These findings reveal a high percentage of boys who do not feel concerned by the HPV vaccine and highlight the need to consider the psychological antecedents of vaccination in general in addition to the specific attitudes to the HPV vaccine.

The intentions of French health university students to recommend and to receive the HPV vaccine are mainly influenced by vaccine knowledge, confidence in vaccines and personal HPV vaccination.

INTRODUCTION: Despite documented effectiveness in preventing several cancers, genital warts and safety of Human Papillomavirus (HPV) vaccine, immunization coverage among French adolescents remains far from the 80 % target. University health students (HS) in France may promote HPV vaccine through a national service (Service Sanitaire des Etudiants en Santé). We aimed to evaluate intentions to recommend the HPV vaccine to friends and relatives, to receive HPV vaccine, and to identify factors associated with these attitudes. METHODS: We conducted a cross-sectional survey in five French Universities from October 2019 to February 2020, using a self-administered online questionnaire. We used bivariable and multivariable logistic regression models to identify determinants of behavior around HPV vaccine: (i) individual intention for vaccination, and (ii) vaccine recommendation to friends and relatives. RESULTS: Among the 732 respondents (180 men, 552 women), 305 (41.7%) reported previous HPV vaccination (54.5 % among women), 504 (68.9%) would recommend the HPV vaccine to friends and relatives, 532 (72.7%) respondents would be vaccinated today if it was recommended for them. Intentions to recommend or to receive the HPV vaccine were less frequent in nursing students compared to medical and pharmacy students. After adjustment for demographical factors, HPV vaccine knowledge was associated with intention [aOR 1.30 (95%-confidence interval, 1.15-1.47)] and recommendation [1.26 (1.10-1.45)], respectively. Additionally, adjusting for knowledge about HPV infections, and confidence in vaccines in general was associated with vaccine intention [1.55, (1.30-1.84)] and recommendation [1.52 (1.24-1.86)]. HPV-vaccinated HS were more prone to recommend the HPV vaccine to friends and relatives [10.9 (6.6-17.9)]. CONCLUSION: A majority of HS would accept and/or recommend HPV vaccines. HS with greater knowledge about the HPV vaccine were more prone to recommend it. Strengthening knowledge about HPV and its vaccination is probably necessary before their Involvement in a HPV immunization program.

Barriers and facilitators to the HPV vaccine: a multicenter qualitative study of French general practitioners.

BACKGROUND: In France, human papillomavirus (HPV) vaccination coverage is low, with 30.7% of 17-year-old girls having received a complete HPV vaccination schedule in 2020. AIM: To determine the perspective and behaviors of general practitioners (GPs) regarding HPV vaccination with their patients and if a reluctance is observed. DESIGN AND SETTING: A qualitative study based on semi-directed individual interviews was conducted between December 2019 and December 2020. A representative sample of GPs with various profiles were included in 4 French regions. METHOD: A purposive sampling was used and interviews were continued until data saturation was reached. The analysis was based on the grounded theory. RESULTS: Twenty-six GPs aged 29-66 years were interviewed. The measures taken by the French health authorities (lowering the target age, reimbursing the vaccine, extending the target population to boys) were perceived as facilitators. The reported barriers were organizational, due to low attendance of adolescents, and relational, mainly due to parental vaccine hesitancy. Physicians had to deal with fears about the perceived risks and concerns about sexuality conveyed by HPV vaccination and linked to the socio-cultural characteristics of the families. Physicians developed strategies, including scientific knowledge mobilization, empowerment of families by promoting health through prevention, repetition of the vaccination proposals, personal experience and relationship. Different practices were identified according to three GP typologies: effective, convinced but unpersuasive, and reluctant physicians. CONCLUSION: Based on these results, specific interventions, including communication techniques, especially for hesitant or unpersuasive physicians, are needed to enable GPs to become more effective.

Nursing home nurses' opinions on the potential evolution of their role in antibiotic stewardship: A French national cross-sectional survey.

AIMS: To assess French nursing home nurses' opinions on the potential evolution of their antibiotic stewardship role, facilitators and barriers, and nurses' characteristics associated with their opinion toward new roles regarding antibiotic prescribing. DESIGN: We conducted a cross-sectional study in French nursing homes with ≥20 beds and for which an email address was available in a national database managed by the French government between May and June 2022. METHODS: A self-administered internet-based questionnaire of 43 closed-ended Likert items was sent to directors of eligible nursing homes by email asking them to forward the link to the questionnaire to the nurses and head nurses of their institution. Data analysis included descriptive statistics and χ2 tests. RESULTS: 7215 nursing homes were sent the online questionnaire; 1090 participants completed it partially or totally and 923 fully filled in the questionnaire. A majority of nurses supported strengthening and expanding their antibiotic stewardship role. Regarding new roles, over 70% agreed that nurses could collect urine samples to perform a urine culture on their own initiative, prescribe microbiological laboratory tests, and change the drug formulation or the administration route of the antibiotic prescribed by the general practitioner. One-third declared that they could initiate antibiotics for some infections and/or change the empirical antibiotic treatment prescribed by the general practitioner. Nurses from public nursing homes with connection to a hospital (27.5% vs. >35% for other status) and with recent experience in nursing homes (31% for <5 years of practice vs. 41% for 10 years or more) were less likely to agree to prescribe antibiotics. CONCLUSIONS: This quantitative questionnaire survey identified potential new nurses' roles in antibiotic stewardship that seem to be acceptable and feasible for participants. These new nurses' roles need to be explored in future experimentations before considering implementation. REPORTING METHOD: The study adhered to relevant EQUATOR guidelines and followed the STROBE reporting guidelines. PATIENT OR PUBLIC CONTRIBUTION: A self-administered internet-based questionnaire was sent to directors of eligible nursing homes by email asking them to forward the link to the questionnaire to the nurses and head nurses of their institution. Nurses and head nurses who were interested and willing could complete the questionnaire online partially or fully. TRIAL AND PROTOCOL REGISTRATION: This study is not a clinical trial and is not eligible for trial registration. We used another suitable study registration site, the Center for Open Science.

Impact of a public commitment charter, a non-prescription pad and an antibiotic information leaflet to improve antibiotic prescription among general practitioners: A randomised controlled study.

BACKGROUND: This study evaluated the effect of a multifaceted antibiotic stewardship intervention on the overall prescription of systemic antibiotics in primary care. Secondary objectives evaluated the effect on the prescription of broad-spectrum antibiotics and the seasonal variation of both total antibiotic and quinolone prescriptions, as a proxy for unnecessary prescribing. METHODS: This pragmatic, randomised, controlled, before-after intervention study was conducted among general practitioners (GPs) who over prescribe antibiotics in Lorraine, France (Intervention group, n = 109; Control group, n = 236; Before period, 01/10/2017-30/09/2018; After period, 01/10/2018-30/09/2019). The intervention included a public commitment charter, a patient information leaflet and a non-prescription pad. Health Insurance data was obtained to calculate overall and broad-spectrum prescription rate (defined daily doses/1000 consultations) and the seasonal variation of prescriptions (%), by period. The intervention effect was measured with general linear mixed models including three independent variables (group, period and group x period interaction). RESULTS: Overall, compared to the Before period, GPs in both groups prescribed significantly fewer systemic antibiotics (p < 0.001) and broad-spectrum antibiotics (p < 0.001) after the intervention was implemented. However, the group x period interaction did not show any evidence that the intervention had an effect on these outcomes. Nevertheless, the intervention did result in a trend towards less seasonal variation in total systemic antibiotic prescription (p = 0.052). CONCLUSIONS: A tendency towards an effect of the intervention to reduce unnecessary antibiotic prescribing during winter months was observed. No effect was observed on the overall volume of systemic antibiotic prescription. This study invites discussion about the challenges faced when evaluating non-pharmacological interventions in primary care.

Can physicians and schools mitigate social inequalities in human papillomavirus vaccine awareness, uptake and vaccination intention among adolescents? A cross-sectional study, France, 2021 to 2022.

BackgroundIn France, human papillomavirus (HPV) vaccination coverage varies across socioeconomic levels.AimWe aimed at assessing HPV vaccine awareness, uptake and vaccination intention among adolescents in France.MethodsIn a cluster-randomised study, 13-15-year-old students in 61 French middle schools completed a web-based questionnaire. We used multivariable logistic regression to evaluate determinants of HPV vaccine awareness, self-reported uptake and vaccination intention among unvaccinated students and interaction terms to explore effects of visits to family physician and remembering school lessons on vaccination. The French deprivation index of school municipalities served as proxy for socioeconomic levels.ResultsAmong 6,992 participants, awareness was significantly associated with parental education (odds ratio (OR) = 0.82; 95% confidence interval (CI): 0.71-0.95), language spoken at home (OR = 0.59; 95% CI: 0.52-0.66) and deprivation level (OR = 0.57; 95% CI: 0.44-0.71), regardless of physician visit or school lessons. Vaccine uptake was associated with parental education without a recent physician visit (OR = 0.31; 95% CI: 0.16-0.59, vs OR = 0.64; 95% CI: 0.52-0.78 with a visit, interaction p = 0.045). Vaccination intention among unvaccinated was associated with deprivation level (moderate-low vs low) among students not remembering school lessons on vaccination (OR = 0.17; 95% CI: 0.05-0.62, vs OR = 0.93; 95% CI: 0.51-1.67 remembering school lessons, interaction p = 0.022). Parental education was associated with vaccination intention among students reporting a physician visit (OR = 0.41; 95% CI: 0.26-0.64 vs OR = 1.05; 95% CI: 0.50-2.20 without a visit, interaction p = 0.034).ConclusionOur results suggest that healthcare and school could promote vaccination and mitigate social inequalities in HPV vaccination coverage.

Psychometric validation of a 7C-model of antecedents of vaccine acceptance among healthcare workers, parents and adolescents in France.

Support for vaccine decision-making requires a tailored approach taking into account psychological antecedents of vaccine acceptance. We aimed at validating an extended 7C-model of antecedents in three different target population groups (healthcare workers [n = 3870], parents [n = 2002] and adolescents [n = 7118]) and two vaccinations (COVID-19, HPV) in France. We performed a secondary analysis of questionnaires collecting sociodemographic characteristics, attitudes and knowledge on vaccination, and vaccine status and intention. We used standard psychometric techniques to validate a first and second order latent structure, and evaluated their association with vaccine intentionality in three levels (refusal, indecision, acceptance). In all populations, the 7C-model yielded a very good model fit (CFI and TLI > 0.90) and, in comparison with non-nested and nested 5C-models, significantly improved the model performance (Ω2, p < 0.05; Wald's test, p < 0.05). The resulting vaccine readiness score was strongly associated with vaccine intentionality (acceptance vs. indecision: ßHCW = 2.93, ßParents = 2.41, ßAdolescents = 1.34; refusal vs. indecision: ßHCW = - 1.68, ßParents = - 0.16, ßAdolescents = - 0.89.). The addition of confidence in the system and social conformism among antecedents of vaccine acceptance allowed a finer understanding of the continuum moving from refusal to indecision and acceptance. To work with these antecedents in interventional research, appropriate questionnaire items should be developed for various vaccines and target populations.

Intravitreal Injection of Bevacizumab for the Prevention of Postoperative Proliferative Vitreoretinopathy in High-Risk Patients Selected by Laser Flare Photometry.

INTRODUCTION: To evaluate the effect of an intravitreal injection of bevacizumab at the time of rhegmatogenous retinal detachment (RRD) surgery, on postoperative proliferative vitreoretinopathy (PVR) in high-risk patients selected by laser flare photometry. METHODS: This single-center observational retrospective cohort study included 137 consecutive patients who underwent pars plana vitrectomy and gas tamponade for primary RRD with increased aqueous flare between July 2016 and June 2021. From June 2019, an intravitreal injection of bevacizumab was administered as an adjunct to RRD repair. Patients who underwent surgery before this time and who did not receive intravitreal bevacizumab served as controls. The main outcome was the rate of retinal redetachment due to PVR. RESULTS: The median flare value was 22.0 (16.5-36.5) pc/ms in the control group and 28.2 (19.7-41.0) pc/ms in the bevacizumab group (p = 0.063). Eyes treated with bevacizumab were more likely to have macula-off RRD (p = 0.003), grade B PVR (p = 0.038), and worse visual acuity (p = 0.004) than controls. The rate of PVR redetachment was significantly lower in the bevacizumab group (11.1%) than in the control (30.1%) (p = 0.012). This difference was more pronounced after adjusting for potential confounding factors (p = 0.005); the risk of developing PVR was 4.5-fold higher in controls (95% CI, 1.6-12.8). After adjustment, the final median visual acuity was also significantly higher in eyes treated with bevacizumab (p = 0.025). CONCLUSION: This pilot study provides preliminary evidence that bevacizumab may reduce the risk of PVR-related recurrent RRD and improve visual outcomes in high-risk patients selected by laser flare photometry.

How can we improve the acceptability of vaccination against Human Papillomavirus (HPV) in France? An original qualitative study with focus groups comprising parents and school staff, interviewed separately.

BACKGROUND: It has been proven that vaccination is effective against Human Papillomavirus (HPV) infections, genital warts, and pre-cancerous and cancerous cervical lesions. Nevertheless, the HPV vaccine coverage of 37.4 % in 2021 in France is one of the lowest in Europe. To explore and understand the reason why French population is so late compared to its neighbours, we carried out focus groups with mothers and with National Education school staff. We aimed to identify knowledge and perceptions of HPV in both study populations, as well as factors influencing HPV vaccination. METHODS: Between January 2020 and March 2021, we performed a qualitative study using an inductive approach with a thematic content analysis (TCA). We conducted semi-structured focus groups with 29 people including 15 mothers of adolescents in middle schools and 14 school staff from the national education system. RESULTS: Different factors influenced the decision-making process of parents and school staff: knowledge and perceptions of HPV and its vaccine, sources of information about HPV and vaccination. Mothers' discourses differed from those of school staff. They mentioned the importance of gynaecological monitoring and the negative image of pharmaceutical companies, and questioned internet as a reliable source of information. For their part, school staff mentioned cultural and/or religious affiliation, municipalities' role to inform the population, and ethical dilemma or logistical challenges regarding HPV vaccination in schools. CONCLUSION: The results of these focus groups provided information on which elements may harm or help HPV vaccination. Identified perceptions, beliefs, knowledge, barriers, and facilitators will help us to build an intervention program focus on general practitioners (GP), school staff, parents, and adolescents.

Co-development of a school-based and primary care-based multicomponent intervention to improve HPV vaccine coverage amongst French adolescents (the PrevHPV Study).

INTRODUCTION: Despite various efforts to improve human papillomavirus (HPV) vaccine coverage in France, it has always been lower than in most other high-income countries. The health authorities launched in 2018 the national PrevHPV research programme to (1) co-develop with stakeholders and (2) evaluate the impact of a multicomponent complex intervention aimed at improving HPV vaccine coverage amongst French adolescents. OBJECTIVE: To describe the development process of the PrevHPV intervention using the GUIDance for rEporting of intervention Development framework as a guide. METHODS: To develop the intervention, we used findings from (1) published evidence on effective strategies to improve vaccination uptake and on theoretical frameworks of health behaviour change; (2) primary data on target populations' knowledge, beliefs, attitudes, preferences, behaviours and practices as well as the facilitators and barriers to HPV vaccination collected as part of the PrevHPV Programme and (3) the advice of working groups involving stakeholders in a participatory approach. We paid attention to developing an intervention that would maximise reach, adoption, implementation and maintenance in real-world contexts. RESULTS: We co-developed three components: (1) adolescents' and parents' education and motivation using eHealth tools (web conferences, videos, and a serious video game) and participatory learning at school; (2) general practitioners' e-learning training on HPV using motivational interviewing techniques and provision of a decision aid tool and (3) easier access to vaccination through vaccination days organised on participating middle schools' premises to propose free of charge initiation of the HPV vaccination. CONCLUSION: We co-developed a multicomponent intervention that addresses a range of barriers and enablers of HPV vaccination. The next step is to build on the results of its evaluation to refine it before scaling it up if proven efficient. If so, it will add to the small number of multicomponent interventions aimed at improving HPV vaccination worldwide. PATIENT OR PUBLIC CONTRIBUTION: The public (adolescents, their parents, school staff and health professionals) participated in the needs assessment using a mixed methods approach. The public was also involved in the components' development process to generate ideas about potential activities/tools, critically revise the successive versions of the tools and provide advice about the intervention practicalities, feasibility and maintenance.

Effect of weight-adjusted intermediate-dose versus fixed-dose prophylactic anticoagulation with low-molecular-weight heparin on venous thromboembolism among noncritically and critically ill patients with COVID-19: the COVI-DOSE trial, a multicenter, randomised, open-label, phase 4 trial.

Background: Venous thromboembolism is a major complication of coronavirus disease 2019 (COVID-19). We hypothesized that a weight-adjusted intermediate dose of anticoagulation may decrease the risk of venous thromboembolism COVID-19 patients. Methods: In this multicenter, randomised, open-label, phase 4, superiority trial with blinded adjudication of outcomes, we randomly assigned adult patients hospitalised in 20 French centers and presenting with acute respiratory SARS-CoV-2. Eligible patients were randomly assigned (1:1 ratio) to receive an intermediate weight-adjusted prophylactic dose or a fixed-dose of subcutaneous low-molecular-weight heparin during the hospital stay. The primary outcome corresponded to symptomatic deep-vein thrombosis (fatal) pulmonary embolism during hospitalization (COVI-DOSE ClinicalTrials.gov number: NCT04373707). Findings: Between May 2020, and April 2021, 1000 patients underwent randomisation in medical wards (noncritically ill) (80.1%) and intensive care units (critically ill) (19.9%); 502 patients were assigned to receive a weight-adjusted intermediate dose, and 498 received fixed-dose thromboprophylaxis. Symptomatic venous thromboembolism occurred in 6 of 502 patients (1.2%) in the weight-adjusted dose group and in 10 of 498 patients (2.1%) in the fixed-dose group (subdistribution hazard ratio, 0.59; 95% CI, 0.22-1.63; P = 0.31). There was a twofold increased risk of major or clinically relevant nonmajor bleeding: 5.9% in the weight-adjusted dose group and 3.1% in the fixed-dose group (P = 0.034). Interpretation: In the COVI-DOSE trial, the observed rate of thromboembolic events was lower than expected in patients hospitalized for COVID-19 infection, and the study was unable to show a significant difference in the risk of venous thromboembolism between the two low-molecular-weight-heparin regimens. Funding: French Ministry of Health, CAPNET, Grand-Est Region, Grand-Nancy Métropole.

A French single-center experience on allogeneic stem cell transplant cryopreservation during severe acute respiratory syndrome coronavirus 2 pandemic.

BACKGROUND AIMS: Allogeneic hematopoietic stem cell transplantation (allo-SCT) is a curative treatment for chemo-resistant hematological malignancies. Because of transport restriction imposed by the coronavirus disease 2019 pandemic, regulatory bodies and societies recommended graft cryopreservation before recipient conditioning. However, the freezing and thawing processes, including washing steps, might impair CD34+ cell recovery and viability, thereby impacting the recipient engraftment. Over 1 year (between March 2020 and May 2021), we aimed to analyze the results of frozen/thawed peripheral blood stem cell allografts in terms of stem cell quality and clinical outcomes. METHODS: Transplant quality was evaluated by comparing total nucleated cells (TNCs), CD34+ cells and colony-forming unit-granulocyte/macrophage (CFU-GM)/kg numbers as well as TNC and CD34+ cell viabilities before and after thawing. Intrinsic biological parameters such as granulocyte, platelet and CD34+ cell concentrations were analyzed, as they might be responsible for a quality loss. The impact of the CD34+ cell richness of the graft on TNC and CD34 yields was evaluated by designing three groups of transplants based on their CD34 /kg value at collection: >8 × 10 6/kg, between 6 and 8 × 106/kg and <6 × 106/kg. The consequences of cryopreservation were compared in the fresh and thawed group by evaluating the main transplant outcomes. RESULTS: Over 1 year, 76 recipients were included in the study; 57 patients received a thawed and 19 patients a fresh allo-SCT. None received allo-SCT from a severe acute respiratory syndrome coronavirus 2-positive donor. The freezing of 57 transplants led to the storage of 309 bags, for a mean storage time (between freezing and thawing) of 14 days. For the fresh transplant group, only 41 bags were stored for potential future donor lymphocyte infusions. Regarding the graft characteristics at collection, median number of cryopreserved TNC and CD34+ cells/kg were greater than those for fresh infusions. After thawing, median yields were 74.0%, 69.0% and 48.0% for TNC, CD34+ cells and CFU-GM, respectively. The median TNC dose/kg obtained after thawing was 5.8 × 108, with a median viability of 76%. The median CD34+ cells/kg was 5 × 106, with a median viability of 87%. In the fresh transplant group, the median TNC/kg was 5.9 × 108/kg, and the median CD34+ cells/kg and CFU-GM/kg were 6 × 106/kg and 276.5 × 104/kg, respectively. Sixty-one percent of the thawed transplants were out of specifications regarding the CD34+ cells/ kg requested cell dose (6 × 106/kg) and 85% of them would have had this dose if their hematopoietic stem cell transplant had been infused fresh. Regarding fresh grafts, 15.8% contained less than 6 × 106 CD34+ cells /kg and came from peripheral blood stem cells that did not reach 6 × 106 CD34+ cells /kg at collection. Regarding the factor that impaired CD34 and TNC yield after thawing, no significant impact of the granulocyte count, the platelet count or the CD34+ cells concentration/µL was observed. However, grafts containing more than 8 × 10 6/kg at collection showed a significantly lower TNC and CD34 yield. CONCLUSIONS: Transplant outcomes (engraftment, graft-versus-host disease, infections, relapse or death) were not significantly different between the two groups.

Promoting HPV vaccination at school: a mixed methods study exploring knowledge, beliefs and attitudes of French school staff.

BACKGROUND: HPV vaccine coverage in France remained lower than in most other high-income countries. Within the diagnostic phase of the national PrevHPV program, we carried out a mixed methods study among school staff to assess their knowledge, beliefs and attitudes regarding HPV, HPV vaccine and vaccination in general, and regarding schools' role in promoting HPV vaccination. METHODS: Middle school nurses, teachers and support staff from four French regions participated between January 2020 and May 2021. We combined: (i) quantitative data from self-administered online questionnaires (n = 301), analysed using descriptive statistics; and (ii) qualitative data from three focus groups (n = 14), thematically analysed. RESULTS: Less than half of respondents knew that HPV can cause genital warts or oral cancers and only 18% that no antiviral treatment exists. Almost 90% of the respondents knew the existence of the HPV vaccine but some misunderstood why it is recommended before the first sexual relationships and for boys; 56% doubted about its safety, especially because they think there is not enough information on this topic. Schools nurses had greater knowledge than other professionals and claimed that educating pupils about HPV was fully part of their job roles; however, they rarely address this topic due to a lack of knowledge/tools. Professionals (school nurses, teachers and support staff) who participated in the focus groups were unfavourable to offering vaccination at school because of parents' negative reactions, lack of resources, and perceived uselessness. CONCLUSIONS: These results highlight the need to improve school staff knowledge on HPV. Parents should be involved in intervention promoting HPV vaccination to prevent their potential negative reactions, as feared by school staff. Several barriers should also be addressed before organizing school vaccination programs in France.

Impact of selective reporting of antibiotic susceptibility testing results for urinary tract infections in the outpatient setting: a prospective controlled before-after intervention study.

OBJECTIVES: The use of selective reporting of antibiotic susceptibility testing (AST) results is a recommended antimicrobial stewardship strategy to improve the appropriateness of antibiotic prescriptions. We conducted a large, pragmatic, prospective, multicentre, controlled (selective reporting versus complete reporting) before-after intervention study to assess the impact of selective reporting of AST results for Escherichia coli-positive urine cultures on the prescription of broad-spectrum antibiotics carrying a higher risk of selection of resistance (i.e. amoxicillin-clavulanate, third-generation cephalosporins, and quinolones) in the outpatient setting. We also looked for possible unintended clinical consequences of the intervention leading to consultations and/or hospitalizations. METHODS: We compared two groups of laboratories located in a French region. We collected data from the health insurance databases before (2017) and after the implementation of the intervention (2019). The primary outcome was the prescription proportion of broad-spectrum antibiotics. RESULTS: We included 42,956 Escherichia coli-positive urine cultures with AST. The decrease in the proportion of broad-spectrum antibiotic prescriptions between 2017 and 2019 was significantly higher for selective reporting of AST, attributable to a decrease in the prescription proportion of third-generation cephalosporins (-8.5% for selective reporting versus -0.1% for complete reporting, p < 0.001). This impact was more marked for targeted therapy and female patients. Requests from clinicians for the complete reporting of AST results were infrequent (1.2% of all the selective AST results reported in 2019). No unintended consequences were observed. DISCUSSION: The results showed a positive impact of the selective reporting of AST results, but room for improvement is still important.

Nurses' perceptions of the potential evolution of their role in antibiotic stewardship in nursing homes: a French qualitative study.

Background: In nursing homes, infections and antibiotic prescriptions are frequent. Nursing home nurses (NHNs) and advanced practice registered nurses (APRNs) could promote antibiotic stewardship (ABS). Few studies have explored nurses' knowledge, perceptions and practices towards ABS in nursing homes and none has investigated the potential evolution of their roles. Objectives: To explore French nurses' perceptions on ABS, current and future potential roles in ABS in nursing homes, as well as facilitators and barriers. Methods: We conducted a qualitative study in north-eastern France between October 2020 and March 2021 using semi-structured individual interviews with NHNs and a focus group with APRNs. Transcripts of the interviews were analysed using a thematic analysis. Results: Twenty NHNs and seven APRNs participated. They were aware of antibiotic misuse and potential adverse events but lacked knowledge on some ABS aspects. NHNs' current ABS roles ranged from the detection of clinical infectious signs to clinical monitoring of residents, with some heterogeneity between nurses. They had positive opinions towards playing a more prominent role in ABS. In the future, with additional training, changes in the legislative framework and greater multidisciplinary teamwork, NHNs thought they could prescribe laboratory microbiological analyses and some targeted antibiotic treatments. APRNs thought they could prescribe first-line antibiotics for urinary tract infections. Conclusions: French NHNs' current ABS roles could be expanded and new roles might be considered while taking into account several facilitators and barriers. According to APRNs, they could help to compensate for the limited presence of doctors in nursing homes and develop infectious diseases skills.