21-Gene Assay to Inform Chemotherapy Benefit in Node-Positive Breast Cancer.

BACKGROUND: The recurrence score based on the 21-gene breast-cancer assay has been clinically useful in predicting a chemotherapy benefit in hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, axillary lymph-node-negative breast cancer. In women with positive lymph-node disease, the role of the recurrence score with respect to predicting a benefit of adjuvant chemotherapy is unclear. METHODS: In a prospective trial, we randomly assigned women with hormone-receptor-positive, HER2-negative breast cancer, one to three positive axillary lymph nodes, and a recurrence score of 25 or lower (scores range from 0 to 100, with higher scores indicating a worse prognosis) to endocrine therapy only or to chemotherapy plus endocrine (chemoendocrine) therapy. The primary objective was to determine the effect of chemotherapy on invasive disease-free survival and whether the effect was influenced by the recurrence score. Secondary end points included distant relapse-free survival. RESULTS: A total of 5083 women (33.2% premenopausal and 66.8% postmenopausal) underwent randomization, and 5018 participated in the trial. At the prespecified third interim analysis, the chemotherapy benefit with respect to increasing invasive disease-free survival differed according to menopausal status (P = 0.008 for the comparison of chemotherapy benefit in premenopausal and postmenopausal participants), and separate prespecified analyses were conducted. Among postmenopausal women, invasive disease-free survival at 5 years was 91.9% in the endocrine-only group and 91.3% in the chemoendocrine group, with no chemotherapy benefit (hazard ratio for invasive disease recurrence, new primary cancer [breast cancer or another type], or death, 1.02; 95% confidence interval [CI], 0.82 to 1.26; P = 0.89). Among premenopausal women, invasive disease-free survival at 5 years was 89.0% with endocrine-only therapy and 93.9% with chemoendocrine therapy (hazard ratio, 0.60; 95% CI, 0.43 to 0.83; P = 0.002), with a similar increase in distant relapse-free survival (hazard ratio, 0.58; 95% CI, 0.39 to 0.87; P = 0.009). The relative chemotherapy benefit did not increase as the recurrence score increased. CONCLUSIONS: Among premenopausal women with one to three positive lymph nodes and a recurrence score of 25 or lower, those who received chemoendocrine therapy had longer invasive disease-free survival and distant relapse-free survival than those who received endocrine-only therapy, whereas postmenopausal women with similar characteristics did not benefit from adjuvant chemotherapy. (Funded by the National Cancer Institute and others; RxPONDER ClinicalTrials.gov number, NCT01272037.).

Determinants of adherence to post-stroke/transient ischemic attack secondary prevention medications: A cohort study.

BACKGROUND: Adherence to post-stroke secondary prevention medications mitigates recurrence risk. This study aimed to measure adherence to secondary prevention medications during 3 years post-ischemic stroke/transient ischemic attack, using prescription and dispensing data, and identify factors associated with suboptimal adherence. METHODS: This multicenter, prospective, cohort study involved patients from the STROKE 69 cohort, which included all consecutive patients with suspected acute stroke admitted between November 2015 and December 2016 to any emergency department or stroke center in the Rhône area in France. Prescription data for antihypertensive agents, antidiabetic agents, lipid-lowering drugs, and antithrombotics were collected. Dispensing data were provided by the French regional reimbursement database. Adherence was calculated using the continuous medication acquisition index. Associations between suboptimal adherence and potential influencing factors across the World Health Organization's five dimensions were explored through univariate and multivariate analyses. RESULTS: From 1512 eligible patients, 365 were included. Optimal adherence to overall treatment (≥90%) was observed in 61%, 62%, and 65% of patients in the first, second, and third years, respectively. Education level (high school diploma or higher: OR = 3.24, 95% CI [1.49; 7.36]) and depression (Hospital Anxiety and Depression Scale-Depression scores 8-10: OR = 1.90, 95% CI [1.05; 3.44]) were significantly associated with suboptimal adherence. CONCLUSIONS: Overall adherence to secondary prevention medications was fairly good. Having an initial diagnosis of transient ischemic attack, a high level of education, or depression was associated with increased odds of suboptimal adherence, while having a history of heart rhythm disorder was associated with lower odds.

Assessment of health literacy in a French emergency department.

BACKGROUND: Health literacy (HL) has become a subject of major interest in public health worldwide. It is known to be linked to self-efficacy in care use and to global health status, and a non-negligible frequency of problematic or inadequate levels of HL in populations worldwide is reported. As this has yet to be evaluated in France, the present study aimed to evaluate the HL level of patients in a French emergency department (ED). METHODS: We conducted a descriptive, cross-sectional observational, single center study in the ED of the Lyon Sud hospital (Hospices civils de Lyon, Lyon, France). The primary endpoint was the HL level of the patients determined according to the score obtained using the 16-item European Health Literacy Survey Questionnaire. The secondary endpoint was the identification of sociodemographic factors associated with the HL level. RESULTS: A total of 189 patients were included for analysis. 10% (95% CI [3%; 17%]) of the patients had an inadequate HL, 38% (95% CI [31%; 45%]) had a problematic HL, and 53% (95% CI [46%; 61%] had an adequate HL. In multivariate analysis, age and perceived health status were independent predictors of the HL level; OR =0.82 (95% CI [0.69; 0.97]; p=0.026) for a 10-year increase in age, and OR =1.84 (95% CI [1.22; 2.82]; p=0.004]). CONCLUSIONS: The HL level of the patients in the ED studied herein was similar to that found in the population of France and other European countries and was influenced by age and perceived health status, which are both associated with care needs. It may be therefore interesting to explore in future studies how taking into consideration HL in the general population may lead to a better self-efficacy in care and optimize the use of the healthcare system.

Assessing patient partnership among emergency departments in France: a cross-sectional study.

OBJECTIVES: This study aims to describe the use of patient partnership, as defined by the Montreal Model, in emergency departments (EDs) in France and report the perception of patient partnership from both the practitioner and patient perspectives. METHODS: This cross-sectional study was conducted between July 2020 and October 2020. First, a survey was sent to 146 heads of EDs in both teaching hospitals and non-teaching hospitals in France to assess the current practices in terms of patient partnership in service organization, research, and teaching. The perceived barriers and facilitators of the implementation of such an approach were also recorded. Then, semi-structured telephone interviews were carried out with patients involved in a service re-organization project. RESULTS: A total of 48 answers (response rate 32.9%) to the survey were received; 33.3% of respondents involved patients in projects relating to service re-organization, 20.8% involved patients in teaching projects, and 4.2% in research projects. Overall, 60.4% of the respondents were willing to involve patients in re-organization or teaching projects. The main barriers mentioned for establishing patient partnership were difficulties regarding patient recruitment and lack of time. The main advantages mentioned were the improvement in patient/caregiver relationship and new ideas to improve healthcare. When interviewed, patients mentioned the desire to improve healthcare and the necessity to involve people with different profiles and backgrounds. A too important personal commitment was the most frequently raised barrier to their engagement. All the patients recognized their positive role, and more generally, the positive role of patient engagement in service re-organization. CONCLUSION: Although this preliminary study indicates a rather positive perception of patient partnership among heads of EDs in France and partner patients, this approach is still not widely applied in practice.

Interaction between cognitive and motor disorders for risk screening of incident falls: results of an elderly population-based observational cohort study.

BACKGROUND: This study aims to examine (1) the association of "Emergency Room Evaluation and Recommendations" (ER2) cognitive and motor items with incident falls (i.e., ≥ 1), their recurrence (i.e., ≥ 2) and post-fall fractures and (2) the performance criteria (i.e., sensitivity, specificity) of the greater identified association for each incident fall outcome in older community dwellers. METHODS: 7147 participants (80.5 ± 3.8; 100% female) of the EPIDémiologie de l'OStéoporose (EPIDOS) observational population-based cohort study were recruited in France. Inability to name the day's date and the use of a walking aid and/or an history of falls were recorded at baseline. Incident outcomes, which were ≥ 1 fall, ≥ 2 falls and post-fall fractures, were collected every 4 months over a period of 4 years. RESULTS: The overall incidence of ≥ 1 fall was 26.4%, 6.4% for ≥ 2 falls, and 19.1% for post-fall fractures. Cox regressions revealed that the use of a walking aid and/or an history of falls [Hazard ratio (HR) ≥ 1.03 with P ≤ 0.011], inability to name the day's date (HR ≥ 1.05 with P ≤ 0.003), and their combination (HR ≥ 1.37 with P ≤ 0.002) were significantly associated with both incident falls, regardless of their recurrence, and post-fall fractures. INTERPRETATION: A significant positive association between ER2 cognitive and motor items, both, respectively, and in combination, with an overall incidence of falls, regardless of their recurrence, as well as with post-fall fractures was demonstrated. However, the low sensitivity and high specificity of the combination of ER2 items suggest that these items cannot be used for risk screening of fall outcomes in the older population.

Toward an Interdisciplinary Approach to Constructing Care Delivery Pathways From Electronic Health Care Databases to Support Integrated Care in Chronic Conditions: Systematic Review of Quantification and Visualization Methods.

BACKGROUND: Electronic health care databases are increasingly used for informing clinical decision-making. In long-term care, linking and accessing information on health care delivered by different providers could improve coordination and health outcomes. Several methods for quantifying and visualizing this information into data-driven care delivery pathways (CDPs) have been proposed. To be integrated effectively and sustainably into routine care, these methods need to meet a range of prerequisites covering 3 broad domains: clinical, technological, and behavioral. Although advances have been made, development to date lacks a comprehensive interdisciplinary approach. As the field expands, it would benefit from developing common standards of development and reporting that integrate clinical, technological, and behavioral aspects. OBJECTIVE: We aimed to describe the content and development of long-term CDP quantification and visualization methods and to propose recommendations for future work. METHODS: We conducted a systematic review following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) recommendations. We searched peer-reviewed publications in English and reported the CDP methods by using the following data in the included studies: long-term care data and extracted data on clinical information and aims, technological development and characteristics, and user behaviors. The data are summarized in tables and presented narratively. RESULTS: Of the 2921 records identified, 14 studies were included, of which 13 (93%) were descriptive reports and 1 (7%) was a validation study. Clinical aims focused primarily on treatment decision-making (n=6, 43%) and care coordination (n=7, 50%). Technological development followed a similar process from scope definition to tool validation, with various levels of detail in reporting. User behaviors (n=3, 21%) referred to accessing CDPs, planning care, adjusting treatment, or supporting adherence. CONCLUSIONS: The use of electronic health care databases for quantifying and visualizing CDPs in long-term care is an emerging field. Detailed and standardized reporting of clinical and technological aspects is needed. Early consideration of how CDPs would be used, validated, and implemented in clinical practice would likely facilitate further development and adoption. TRIAL REGISTRATION: PROSPERO CRD42019140494; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=140494. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2019-033573.

Factors perceived by health professionals to be barriers or facilitators to caries prevention in children: a systematic review.

BACKGROUND: Considered the most prevalent noncommunicable disease in childhood, dental caries is both an individual and a collective burden. While international guidelines highlight prevention as a major strategy for caries management in children, health professionals still struggle to implement prevention into their clinical practice. Further research is needed to understand the gap between the theoretical significance of dental prevention and its lack of implementation in the clinical setting. This systematic review aims to identify and classify factors perceived by health professionals to be barriers or facilitators to caries prevention in children. METHOD: A systematic literature search was conducted in three electronic databases (Medline, Web of Science and Cairn). Two researchers independently screened titles, abstracts and texts. To be selected, studies had to focus on barriers or facilitators to caries prevention in children and include health professionals as study participants. Qualitative and quantitative studies were selected. The factors influencing caries prevention in children were sorted into 3 main categories (clinician-related factors, patient-related factors, and organizational-related factors) and then classified according to the 14 domains of the theoretical domains framework (TDF). RESULTS: A total of 1771 references were found by combining manual and database searches. Among them, 26 studies met the inclusion criteria, of which half were qualitative and half were quantitative studies. Dentists (n = 12), pediatricians (n = 11), nurses (n = 9), and physicians (n = 5) were the most frequently interviewed health professionals in our analysis. Barriers and facilitators to caries prevention in children were categorized into 12 TDF domains. The most frequently reported domains were Environmental Context and Resources, Knowledge and Professional Role and Identity. CONCLUSION: This systematic review found that a wide range of factors influence caries prevention in children. Our analysis showed that barriers to pediatric oral health promotion affect all stages of the health care system. By highlighting the incompatibility between the health care system's organization and the implementation of caries prevention, this study aims to help researchers and policy-makers design new interventions to improve children's access to caries prevention. TRIAL REGISTRATION: PROSPERO CRD42022304545.

Frequency and determinants of technical procedures in French general practice: a cross-sectional study.

INTRODUCTION: Technical skills have many areas of application in general practice and are a dimension of medical competence. Several studies have attempted to describe the technical procedures performed in general practice but most had limitations in the data collection process, the scope of the procedures addressed, or the healthcare actors involved. No French comparable data have been published. The aim of the present study was therefore to describe the frequency and type of technical procedures in French general practice, and to assess their determinants, in particular rurality. METHODS: The present study was ancillary to the ECOGEN (Eléments de la COnsultation en médecine GENérale) study, which was an observational cross-sectional, multicentre, nationwide study conducted in 128 French general practices. Data were collected on 20 613 patient-GP encounters, including the characteristics of GPs and encounters, as well as the health problems managed during the encounter and their associated processes of care; the latter two variables were coded according to the International Classification of Primary Care classification. The GPs' practice location was first classified as rural area, urban cluster, or urban area; the former two categories were combined for analysis. The various technical procedures were classified according to the framework of the International Classification of Process in Primary Care. The frequency of each technical procedure was compared according to GP practice location. The dependent variable analysed was the performance of at least one technical procedure per each health problem managed. Bivariate analysis was performed for all independent variables followed by multivariate analysis for key variables, using a hierarchical model including three levels: the physician, the encounter, the health problem managed. RESULTS: The data included 2202 technical procedures performed. At least one technical procedure was performed in 9.9% of encounters and for 4.6% of health problems managed. The two most frequent groups of technical procedures performed were injections (44.2% of all procedures) and clinical laboratory procedures (17.0%). The following procedures were more often performed by GPs practicing in a rural area or an urban cluster than those practicing in an urban area: injection of joints, bursae, tendons and tendon sheaths (4.1% v 1.2% of all procedures), manipulation and osteopathy (10.3% v 0.4%), excision/biopsy of superficial lesions (1.7% v 0.5%), and cryotherapy (1.7% v 0.3%). Conversely, the following procedures were more often performed by GPs practicing in urban areas: vaccine injection (46.6% v 32.1%), point-of-care testing for group A streptococci (11.8% v 7.6%), and ECG (7.6% v 4.3%). GPs practicing in a rural area or an urban cluster performed more often technical procedures than those practising in an urban area (odds ratio=1.31, 95% confidence interval 1.04-1.65), according to the multivariate model. CONCLUSION: Technical procedures were more frequently performed and more complex when they were performed in French rural and urban cluster areas. More studies are required to assess patients' needs regarding technical procedures.

Mandatory immunizations for health students in Lyon (France), overview and evaluation / Obligations d'immunisation des étudiants en santé de Lyon, état des lieux et évaluation

OBJECTIVES: To establish an overview of vaccination amongst health students in Lyon 1 University and to evaluate the implementation of a new verification system of immunization obligations with an electronic vaccination card (EVC) from the “MesVaccins.net” website. METHODS: A questionnaire was sent by the Lyon 1 University Student Health Service (SHS) to the first-year health studies students over the age of 18 in Lyon in 2020-2021 who shared their EVC; exploitation of these EVCs’ data. RESULTS: Amongst all students, 67.4% transmitted their information to the SHS. They reported organizational difficulties in updating (33.3%) and certifying their EVC with a healthcare professional (55.9%). Global satisfaction of the students was 78.0%. This study highlighted many differences between Lyon Est and Lyon Sud campuses, especially about general knowledge of the SHS, visibility of the promotion campaign, rate of students who transmitted their information to the SHS and rate of up-to-date students. Regarding mandatory immunization, 83.4% of the students were up-to-date with diphtheria-tetanus-poliomyelitis, 56.8% with hepatitis B, and 64.7% had done a tuberculin intradermal test; 43.4% of the students were simultaneously up-to-date with these three immunizations. CONCLUSION: The rate of up-to-date students is insufficient. This study stresses the necessity of an early campaign of immunizations promotion, with better access to healthcare professionals able to certify EVCs.

Objectifs: Établir un état des lieux de la vaccination des étudiants en santé de l'université Lyon 1 et évaluer la mise en place d'un nouveau dispositif de vérification des obligations d'immunisation à l'aide du carnet de vaccination électronique (CVE) MesVaccins.net. Méthodes: Questionnaire envoyé par le Service de santé universitaire (SSU) de Lyon 1 aux étudiants majeurs en première année de santé en 2020-2021 ayant partagé leur CVE ; exploitation des données de ces CVE. Résultats: Les étudiants étaient 67,4 % à avoir transmis leurs informations au SSU. Ils ont rapporté des difficultés organisationnelles pour se mettre à jour (33,3 %) et pour faire valider leur CVE par un professionnel de santé (55,9 %). La satisfaction globale des étudiants vis-à-vis de ce dispositif était de 78,0 %. Cette étude a mis en avant plusieurs différences entre les campus de Lyon Est et Lyon Sud, notamment sur la connaissance du SSU, la visibilité de la campagne, le pourcentage d'étudiants qui ont transmis leurs informations et le pourcentage d'étudiants à jour. Concernant les immunisations obligatoires, 83,4 % des étudiants étaient à jour du vaccin diphtérie-tétanos-poliomyélite, 56,8 % de l'hépatite B et 64,7 % avaient pratiqué une intradermoréaction ; 43,4 % des étudiants étaient à jour simultanément de ces trois immunisations. Conclusion: Le pourcentage d'étudiants à jour est insuffisant. Cette étude souligne la nécessité d'une campagne précoce de promotion des immunisations avec un meilleur accès des étudiants à des professionnels de santé validant les CVE.

[Learning motivational interviewing to better support patient medication adherence]. / Se former à l'entretien motivationnel pour mieux soutenir l'adhésion thérapeutique des patients.

Motivational interviewing (MI), developed in the 1980s, demonstrated efficacy in helping patients to change their health behavior, and more recently in supporting patient therapeutic adherence. However, the training in patient therapeutic adherence support is poor and unequally distributed within the initial and continuing training of health professionals. To cope, an interprofessional continuing training was designed by health professionals and researchers, aiming at acquiring fundamental knowledge in therapeutic adherence and MI skills. The results of the first training session should encourage health professionals to train, and decision-makers to promote wider dissemination of this training.

Depuis son développement dans les années 1980, l'entretien motivationnel (EM) s'est avéré efficace pour accompagner les patients à modifier leur comportement en santé, et plus récemment dans le soutien de leur adhésion thérapeutique. Cependant, la formation au soutien de l'adhésion thérapeutique est pauvre et inégalement répartie au sein de la formation initiale et continue des professionnels de santé. Face à ce constat, une formation continue interprofessionnelle a été conçue par des professionnels de santé et chercheur-e-s, visant à l'acquisition des connaissances fondamentales en adhésion thérapeutique et des compétences en EM. Les résultats objectivés par la première session de formation devraient inciter les professionnels de santé à se former et les décideurs à favoriser une diffusion plus large de ce type de formation.

Envisioning clinical trials as complex interventions.

Clinical trials are critical components of modern health care and infrastructure. Trials benefit society through scientific advancement and individual patients through trial participation. In fact, billions of dollars are spent annually in support of these benefits. Despite the massive investments, clinical trials often fail to accomplish their primary aims and trial enrollment rates remain low. Prior efforts to improve trial conduct and enrollment have had limited success, perhaps due to oversimplification of the complex, multilevel nature of trials. For these reasons, the authors propose applying implementation science to the clinical trials context. In this commentary, the authors posit clinical trials as complex, multilevel evidence-based interventions with significant societal and individual benefits yet with persistent gaps in implementation. An application of implementation science concepts to the clinical trials context as means to build common vocabulary and establish a platform for applying implementation science and practice to improve clinical trial conduct is introduced. Applying implementation science to the clinical trials context can augment improvement efforts and build capacity for better and more efficient evidence-based care for all patients and trial stakeholders throughout the clinical trials enterprise.

Considering health literacy in cardiovascular disease management: a qualitative study on healthcare professionals' and patients' perspectives.

BACKGROUND: Implementing practices adapted to patient health literacy (HL) is a promising avenue for improving their outcomes in the context of cardiovascular diseases (CVD). The health communication skills of healthcare professionals (HCPs) and the quality of information provided are essential for low-HL patients. We aimed to explore HCP knowledge about HL, patients' and HCPs' views on current practices regarding low-HL patients, and facilitators and barriers to adapting communication to patients' HL level, in order to prepare the implementation of a complex intervention dedicated to improve CVD management for low-HL patients. METHODS: We conducted face-to-face semi-structured interviews with HCPs practicing in cardiology units and patients hospitalized for CVD. The study design and analysis were based on the Theory of Planned Behavior for HCPs and on the framework of Health Literacy and Health Action for patients. Deductive and inductive thematic analysis were used. Barriers and facilitators were structured into an Ishikawa fishbone diagram and implementation strategies were selected to address resulting themes from the Expert Recommendations for Implementing Change (ERIC). RESULTS: Fifteen patients and 14 HCPs were interviewed. HCPs had partial knowledge of HL dimensions. Perceptions of HCPs and patients were not congruent regarding HCP-patient interactions and information provided by hospital and community HCPs. HCPs perceived they lacked validated tools and skills, and declared they adapted spontaneously their communication when interacting with low-HL patients. Patients expressed unmet needs regarding communication during hospital discharge and at return to home. CONCLUSION: To implement HL-tailored practices in this setting, our results suggest that several implementation strategies will be valuable at individual (engaging patients and their family), interactional (educating and training of HCPs about HL), and organizational levels (creating a multidisciplinary HCP interest group dedicated to HL). TRIAL REGISTRATION: ClinicalTrials.gov, (NCT number) NCT03949309, May 10, 2019.

Co-design and evaluation of a patient-centred transition programme for stroke patients, combining case management and access to an internet information platform: study protocol for a randomized controlled trial - NAVISTROKE.

BACKGROUND: Stroke affects many aspects of life in stroke survivors and their family, and returning home after hospital discharge is a key step for the patient and his or her relatives. Patients and caregivers report a significant need for advice and information during this transition period. Our hypothesis is that, through a comprehensive, individualised and flexible support for patients and their caregivers, a patient-centred post-stroke hospital/home transition programme, combining an Internet information platform and telephone follow-up by a case manager, could improve patients' level of participation and quality of life. METHODS: An open parallel-group randomized trial will be conducted in two centres in France. We will recruit 170 adult patients who have had a first confirmed stroke, and were directly discharged home from the stroke unit with a modified Rankin score ≤3. Intervention content will be defined using a user-centred approach involving patients, caregivers, health-care professionals and social workers. Patients randomized to the intervention group will receive telephonic support by a trained case manager and access to an interactive Internet information platform during the 12 months following their return home. Patients randomized to the control group will receive usual care. The primary outcome is patient participation, measured by the "participation" dimension score of the Stroke Impact Scale 6 months after discharge. Secondary outcomes will include, for patients, quality of life, activation, care consumption, as well as physical, mental and social outcomes; and for caregivers, quality of life and burden. Patients will be contacted within one week after discharge, at 6 and 12 months for the outcomes collection. A process evaluation alongside the study is planned. DISCUSSION: Our patient-centred programme will empower patients and their carers, through individualised and progressive follow-up, to find their way around the range of available healthcare and social services, to better understand them and to use them more effectively. The action of a centralised case manager by telephone and the online platform will make it possible to disseminate this intervention to a large number of patients, over a wide area and even in cases of geographical isolation. TRIAL REGISTRATION: ClinicalTrials NCT03956160 , Posted: May-2019 and Update: September-2021.

Improving the delivery of team-based survivorship care after primary breast cancer treatment through a multi-level intervention: a pilot randomized controlled trial.

PURPOSE: We developed and tested a multi-level intervention, ConnectedCancerCare (CCC), which includes a tailored website and appointment reminder system for women with early-stage breast cancer and a provider summary letter sent to their medical oncologist and primary care provider to improve the delivery of team-based survivorship care. METHODS: We conducted a pilot randomized controlled trial to establish the feasibility and acceptability of CCC. Women diagnosed with stages 0-II breast cancer within one year of completing primary treatment were randomized to CCC (intervention) or a static online survivorship care plan (control). Participants completed baseline and 3-month follow-up surveys online. Post-trial interviews with 5 PCPs, 6 oncology providers, and 8 intervention patients were conducted. RESULTS: Of the 160 eligible women invited to participate, 66 completed the baseline survey and were randomized (41%) and 54 completed a follow-up survey (83%). Participants in the intervention arm found the CCC content to be acceptable, with 82% reporting it was easy to use and 86% reporting they would recommend it to other patients. Women randomized to CCC (vs. control) more often reported scheduling a PCP follow-up visit (64% vs. 42%), communicating with their PCP about provider roles (67% vs. 18%), and higher mean team-based cancer care knowledge scores (3.7 vs. 3.4). CONCLUSION: Deploying CCC in medical oncology practices was feasible, and the intervention content was acceptable. CCC shows promise for improving patient knowledge and patient-provider communication about provider roles in team-based cancer care and encouraging patients to engage with their PCP early in the survivorship period.

A randomized, placebo-controlled phase 2 study of paclitaxel in combination with reparixin compared to paclitaxel alone as front-line therapy for metastatic triple-negative breast cancer (fRida).

PURPOSE: CXCR1, one of the receptors for CXCL8, has been identified as a druggable target on breast cancer cancer stem cells (CSC). Reparixin (R), an investigational oral inhibitor of CXCR1, was safely administered to metastatic breast cancer patients in combination with paclitaxel (P) and appeared to reduce CSC in a window-of-opportunity trial in operable breast cancer. The fRida trial (NCT02370238) evaluated the addition of R to weekly as first-line therapy for metastatic (m) TNBC. SUBJECTS AND METHODS: Subjects with untreated mTNBC were randomized 1:1 to R or placebo days 1-21 in combination with weekly P 80 mg/m2 on days 1, 8, 15 of 28-day cycles. The primary endpoint was PFS by central review. RESULTS: 123 subjects were randomized (62 to R + P and 61 to placebo + P). PFS was not different between the 2 groups (median 5.5 and 5.6 months for R + P and placebo + P, respectively; HR 1.13, p = 0.5996). ALDH+ and CD24-/CD44+ CSC centrally evaluated by IHC were found in 16 and 34 of the 54 subjects who provided a metastatic tissue biopsy at study entry. Serious adverse events (21.3 and 20% of subjects) and grade ≥ 3 adverse reactions (ADR) (9.1 and 6.3% of all ADRs) occurred at similar frequency in both groups. CONCLUSION: fRida is the first randomized, double-blind clinical trial of a CSC-targeting agent in combination with chemotherapy in breast cancer. The primary endpoint of prolonged PFS was not met. CLINICAL TRIAL REGISTRATION/DATE OF REGISTRATION: NCT01861054/February 24, 2015.

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.

Poor Involvement of General Practitioners in Decisions of Withholding or Withdrawing Life-Sustaining Treatment in Emergency Departments.

BACKGROUND: Decisions of withholding or withdrawing life-sustaining treatment are frequent in emergency departments (ED) and patients are often unable to communicate their wishes concerning end of life desires. OBJECTIVE: To evaluate the participation of general practitioners (GPs) during the decision-making process of withholding or withdrawing life-sustaining treatments in ED. DESIGN: Prospective observational multicenter study. PATIENTS: We included patients for whom a decision of withdrawing or withholding life-sustaining treatments was made in ED. For each patient, we enrolled one general practitioner. MAIN MEASURES: GPs were interviewed about their perception of end of life patient's management and the communication with ED and families. KEY RESULTS: There were 109 potential patient participants. We obtained answers from 54 (49.5%) of the patient's associated GPs. Only 4 (7.4%) GPs were involved during the decision-making process of withholding or withdrawing life-sustaining treatments. Among GPs, 29 (53.7%) were contacted by family after the decision, most often to talk about their difficult experience with the decision. A majority (94%) believed their involvements in these decisions were important and 68% wished to "always" participate in end of life decisions despite the fact that they usually don't participate in these decisions. Finally, 66% of GPs believed that management of end of life in the emergency department was a failure and should be anticipated. CONCLUSIONS: GPs would like to be more involved and barriers to GP involvement need to be overcome. We do not have any outcome data to suggest that routine involvement of GPs in all end of life patients improves their outcomes. Moreover, it requires major system and process-based changes to involve all primary care physicians in ED decision-making. NIH TRIAL REGISTRY NUMBER: NCT02844972.

Choice of Initial Brain Imaging in Patients with Suspected Acute Stroke: STROKE69, a Population-Based Study.

BACKGROUND: In patients with suspected stroke, brain imaging is recommended in the acute phase for appropriate management and treatment. Both computed tomography (CT) and magnetic resonance imaging (MRI) are considered reasonable choices for initial brain imaging. When both techniques are available, choosing one or the other might be associated with specific factors related either to patients, stroke symptoms, and severity or management organization. METHODS: The study was performed within the STROKE 69 database, a population-based cohort of all adult patients with suspected stroke admitted in one of the emergency departments (ED), primary stroke center, or stroke center of the Rhône County, from November 2015 to December 2016. Patients were included if they were admitted within 24 h following either symptom onset or last known normal. To identify factors potentially associated with the choice of initial brain imaging, a multivariate logistic regression was performed. RESULTS: Among the 3,244 patients with suspected stroke enrolled in the STROKE69 cohort, 3,107 (95.8%) underwent brain imaging within the first 24 h after admission. Among those 74.6% underwent CT as initial imaging while 25.4% had an MRI. In multivariate analyses, several factors were associated with a lower probability of having an MRI as initial brain imaging versus CT. These were either patient characteristics: older age (>80 years old, OR 0.39 [95% CI 0.28-0.54]), preexisting disability (OR 0.55 [95% CI 0.36-0.84]), use of anticoagulants (OR 0.52 [95% CI 0.33-0.81]), stroke characteristics: stroke of unknown onset (OR 0.42 [95% CI 0.31-0.58]) or factors associated with overall management: onset-to-door time (>6 h, OR 0.38 [95% CI 0.23-0.60]), initial admission to ED (OR 0.02 [95% CI 0.02-0.04]) or intensive care unit (OR 0.01 [95% CI 0.001-0.08]), personal transport (OR 0.66 [95% CI 0.45-0.96]), and admission during working hours (OR 0.65 [95% CI 0.51-0.84]). CONCLUSIONS: Besides CT or MRI availability, a number of other parameters could influence the choice of first imaging in case of stroke suspicion. These are related to patient characteristics, type of stroke symptoms, and type of organization.

Impact of a theory-informed and user-centered stroke information campaign on the public's behaviors, attitudes, and knowledge when facing acute stroke: a controlled before-and-after study.

BACKGROUND: Public awareness of stroke symptoms is a key factor to ensure access to reperfusion strategies in due time. We designed and launched a regional theory-informed and user-centered information campaign and assessed its impact on emergency medical services (EMS) calls for stroke suspicion, time-to-call, and public attitudes and awareness concerning stroke. METHODS: A controlled before-and-after study was conducted during 3 sequential time-periods in 2 separate counties. Key messages of the campaign were underpinned by stroke representations and the theory of planned behavior, and focused on recognition of stroke warning signs and the need to call EMS urgently. The campaign included posters, leaflets, adverts and films displayed in bus and subway stations, internet, social networks, and local radio. Outcome measures on behavior, attitudes, and knowledge were assessed before the launch of the campaign, at 3 months, and 12 months. RESULTS: The number of EMS calls for stroke suspicion increased by 21% at 12 months in the intervention county and this change was significantly different to that observed in the control county (p = 0.02). No significant changes were observed regarding self-reported attitudes in case of stroke. An 8% significant increase in recognizing at least 2 stroke warning signs was observed in the intervention county (p = 0.04) at 3 months, while it did not change significantly in the control county (p = 0.6). However, there was no significant difference in warning sign recognition between both counties (p = 0.16). CONCLUSION: The campaign significantly improved public's behavior of calling EMS, although stroke knowledge was not improved as much as expected. Repeating these campaigns over time might further help improve timeliness and access to reperfusion strategies. TRIAL REGISTRATION: Clinical Trial Registration-URL: http://www.clinicaltrials.gov . Unique identifier: NCT02846363 .

Myocardial infarction: Economic, health, and social impacts on informal caregivers.

OBJECTIVES: The aim of the study was to measure the economic impact of informal care (IC) on caregivers assisting myocardial infarction (MI) survivors in France. Health and social impacts were also described. METHODS: Data from the prospective 2008 Health and Disabilities Households Survey (Enquête Handicap-Santé), carried out among the French general population, were used to obtain information about patients with MI and their informal caregivers. To estimate the approximate monetary value of IC, three methods were used: the proxy good method, opportunity cost method (OCM), and contingent valuation method (CVM). A multivariate analysis was performed to determine the associations of the IC duration and the existence of professional care with the health indicators stated by caregivers. RESULTS: The analysis included data from 147 caregivers. The mean value of IC ranged from €9,679 per year using the CVM to €11,288 per year using the OCM (p > .05). The mean willingness to pay for an additional hour of IC was €10.9 (SD = 8.3). A total of 46.2 percent of caregivers reported that IC negatively affected theirs physical condition, and 46.3 percent reported that it negatively affected their psychological health. In addition, 40.1 percent declared that caregiving activity made them anxious and 38.8 percent stated they felt alone. Associations were identified between the duration of IC and feeling the need to be replaced, feeling alone and making sacrifices (p < .05). CONCLUSIONS: Informal caregiver burden may be recognized in health technology assessment in order not to underestimate the cost of strategies and to facilitate the comparability of cost-effectiveness outcomes between studies.