Breast cancer: a randomized controlled trial assessing the effect of a decision aid on mammography screening uptake: study protocol

IntroductionBreast cancer (BC) is the primary cancer among women. The World Health Organization recommends a bilateral screening mammogram every 2 years for women aged 50 to 74 years. However, it has been shown that there is an absence of information about the benefits and risks of screening. Shared medical decision-making is important to ensure patients are involved in the decision process. Decision aids can facilitative this decision-making process. This article presents a protocol to evaluate the effect of a decision aid on participation rates in the French organized BC screening program.Methods and analysisDesign and setting. The design is a 2 arm randomized controlled study, performed in the Pays de la Loire region (French West Coast). Randomization will be based on general medicine practices (Primary Care).ParticipantsWomen aged between 50 and 74 years, eligible for BC screening. In this region, there are 75000 women, and 2800 general practitioners eligible for recruitment.InterventionIn the « Decision aid for organized cancer screening » arm, the intervention will distribute invitation letters to eligible women combined with the provision of decision aid to these women and their general practitioners and an incentive to implement shared medical decision-making. In the « Standard organized cancer screening » arm, only the screening invitation will be sent to eligible women.Primary endpointBC screening participation rates will be assessed after an 18-month follow-up period.Statistical analysisIn this non-inferiority trial, the percentage of women who are up-to-date with their screening at 18 months after the intervention will be compared across arms using a generalized mixed linear model.DiscussionThe research team expect to demonstrate that providing a better explanation of the benefits and risks of BC screening is not at odds with screening participation. The study results should help policy makers thinking about implementing shared medical decision-making within the framework of organized BC screening programs in the future.Ethics and disseminationOn 6 December 2021, the protocol received a favorable opinion from the French Committee for the Protection of Persons (2021-A01583-38). This study is registered with ClinicalTrials.gov, number NCT05607849. (Version 1, November 7, 2022; https://www.clinicaltrials.gov/ct2/show/NCT05607849). The study findings will be used for publication in peer-reviewed scientific journals and presentations in scientific meetings

Impact of STROBE Statement Publication on Quality of Observational Study Reporting: Interrupted Time Series versus Before-After Analysis

Background:In uncontrolled before-after studies, CONSORT was shown to improve the reporting of randomised trials. Before-after studies ignore underlying secular trends and may overestimate the impact of interventions. Our aim was to assess the impact of the 2007 STROBE statement publication on the quality of observational study reporting, using both uncontrolled before-after analyses and interrupted time series.Methods:For this quasi-experimental study, original articles reporting cohort, case-control, and cross-sectional studies published between 2004 and 2010 in the four dermatological journals having the highest 5-year impact factors (≥4) were selected. We compared the proportions of STROBE items (STROBE score) adequately reported in each article during three periods, two pre STROBE period (2004-2005 and 2006-2007) and one post STROBE period (2008-2010). Segmented regression analysis of interrupted time series was also performed.Results:Of the 456 included articles, 187 (41%) reported cohort studies, 166 (36.4%) cross-sectional studies, and 103 (22.6%) case-control studies. The median STROBE score was 57% (range, 18%-98%). Before-after analysis evidenced significant STROBE score increases between the two pre-STROBE periods and between the earliest pre-STROBE period and the post-STROBE period (median score2004-0548% versus median score2008-1058%, p<0.001) but not between the immediate pre-STROBE period and the post-STROBE period (median score2006-0758% versus median score2008-1058%, p = 0.42). In the pre STROBE period, the six-monthly mean STROBE score increased significantly, by 1.19% per six-month period (absolute increase 95%CI, 0.26% to 2.11%, p = 0.016). By segmented analysis, no significant changes in STROBE score trends occurred (-0.40%; 95%CI, -2.20 to 1.41; p = 0.64) in the post STROBE statement publication.Interpretation:The quality of reports increased over time but was not affected by STROBE. Our findings raise concerns about the relevance of uncontrolled before-after analysis for estimating the impact of guidelines

Improving the Management of Older Patients with Cancer : Identification Elements of Frailty

INTRODUCTION : La majorité des cancers survient chez la personne âgée. Cette population est hétérogène du fait de la prévalence de comorbidités, d’incapacités et de syndromes gériatriques contribuant à la fragilité. Ces éléments rendent complexe le choix de la stratégie thérapeutique à adopter. L’évaluation gériatrique approfondie (EGA) est recommandée pour évaluer la fragilité de ces patients. L’objectif général était d’identifier parmi les patients âgés de 70 ans et plus atteints de cancer, ceux qui présentaient un haut risque de morbi-mortalité afin de limiter les thérapeutiques agressives et proposer une prise en charge adaptée. Les objectifs spécifiques étaient : 1/d’identifier les facteurs oncologiques et paramètres de l’EGA conjointement associés au décès à 1 an, 2/d’identifier des profils de santé et de les valider sur la morbi-mortalité, 3/ d’évaluer la concordance entre 4 classifications de fragilité et de comparer leurs performances pronostiques. METHODES : ces travaux ont été réalisés à partir de la cohorte dynamique prospective ELCAPA (Elderly CAncer PAtient) qui inclut consécutivement tous les patients âgés de 70 ans et plus, avec un diagnostic de cancer solide ou hématologique et adressés en consultation d’oncogériatrie, dans 2 centres hospitalo-universitaires parisiens. Entre 2007 et 2012, 1 021 patients ont été inclus. Les critères de jugements étaient la mortalité globale à 1 an, les hospitalisations non programmées à 6 mois et la décision finale de traitement (curative, palliative). Nous avons analysé les facteurs associés au décès à 1 an de 993 patients à l’aide de modèles de Cox. Nous avons ensuite réalisé une analyse en classes latentes (ACL) sur cas-complets (n=821), avec analyses de sensibilité incluant les données manquantes (n= 1 021), puis selon le statut métastatique et validé cette typologie sur 375 nouveaux patients inclus dans la cohorte. La dernière étude a été réalisée sur 763 patients avec données complètes pour 4 classifications étudiées à l’aide de modèles de Cox (décès) et régression logistique (hospitalisations).RESULTATS: L’âge moyen était de 80,2 ans, 51,2% étaient des hommes, 21,4% avaient un cancer colorectal et 45% des métastases. Le nombre de comorbidités sévères (P≤0,05), la dénutrition (P80 ans (P≤0,05), le site tumoral et statut métastatique (P80 years (P<0.05), tumor site and metastatic status (P<0.001) were associated with death independently from impaired ECOG-PS (P<0.001), ADL (P<0.001), and GUG (P<0.001). LCA displayed 4 health profiles: those relatively healthy [LC1, 28.3%], malnourished [LC2, 35.8%], with cognitive and/or mood impairments [LC3, 15.1%], and gloablly impaired [LC4, 20 8%]. In adjusted pairwise comparisons, compared to LC1, the three other LCs were associated with higher risks of palliative treatment, death, and unplanned admission. LC4 was associated with 1-year mortality and palliative treatment compared to LC2 and LC3. For unplanned admissions, no differences were demonstrated across these three LCs. Patient distribution differed significantly across the four classifications, i.e., Latent class Typology, Balducci, SIOG1 and SIOG2 (P<0.001). Agreement between these four classifications was globally poor to moderate. For mortality, discrimination was good for the 4 models (C-index ≥0.70) with slightly better performance for SIOG 1-model. For hospitalizations, performance was good and close between the four models (C-index ≥0.70). None of the four classifications performed best for all the three tumor sites.CONCLUSIONS: We showed the usefulness of GA and especially some GA-parameters to identify among older patients, those who are frail. Intervention studies are needed to assess the impact of GA on morbi-mortality and quality of life of those patients

Les femmes ne participant pas au dépistage organisé du cancer du sein en raison de la réalisation du dépistage individuel : exploration des représentations par focus groups

Le Dépistage organisé du cancer du sein (DOCS) impulsé par la DGS a été généralisé en 2004. L objectif est une participation de 70% selon les recommandations européennes pour obtenir une baisse de la mortalité. Ce taux s élevait à 52.8 % en 2008-2009 et à 45,8% dans le Val-de-Marne témoignant d une participation insuffisante. La thèse de Marina Brodbeck soutenue en 2010 à la faculté de médecine de Créteil étudiait les motifs de non participation au DOCS dans le Val de Marne. La raison principale de non participation au DOCS était la réalisation du dépistage individuel (DI) (39.4%). Le but de notre étude était d étudier les raisons et motivations des femmes non participantes au DOCS à réaliser le DI, à travers leurs représentations de la santé, de la féminité, du cancer et du dépistage du cancer du sein. Nous avons réalisé 3 focus groups constitués de 4 à 6 femmes recrutées à partir du travail de Marina Brodbeck. Les femmes attachent une grande attention à leur santé et à un dépistage personnalisé. Pour elles, le sein est surtout l organe de l allaitement. Elles ont peur du cancer et plus spécifiquement de localisation gynécologique. La mammographie est bien connotée et acceptée. Elles ne connaissent pas parfaitement les modalités du DOCS : la double lecture est souvent ignorée, le courrier d invitation leur semble peu explicite, elles expriment des doutes ou craintes concernant la fiabilité des centres ou des appareils de mammographies, et de la peur d un changement de centre lors du passage au DOCS. La discordance entre la date de réception du courrier et la réalisation de leur dernière mammographie, le caractère généralisé non individuel constituent des freins importants au DOCS. Ces éléments pourraient conduire à des actions permettant d améliorer la participation au DOCS notamment en y impliquant plus explicitement les médecins cliniciens.The organised screening for breast cancer (DOCS) driven by the DGS was widespread in 2004. The objective is a 70% participation rate according to European recommendations to obtain a decrease in mortality. This rate was 52.8% in 2008-2009 and 45.8% in the Val-de-Marne indicating insufficient participation. Marina Brodbeck s thesis sustained by 2010 at the Faculty of Medicine of Créteil was studying the reasons for non-participation in the DOCS in the Val de Marne. The main reason for non-participation in the DOCS was the realisation of individual screening (39.4%). The aim of our study was to investigate the reasons and motivations of not participating women in the DOCS to the DI through their representations of health, femininity, cancer screening and breast cancer. We conducted three focus groups consisting of 4 to 6 women recruited from Marina Brodbeck s work. Women attach great attention to their health and personal screening. For them, the breast is mainly the organ of breastfeeding. They are afraid of cancer and more specifically of gynecological localisation. Mammography is well connoted and accepted. They don t know perfectly modalities of the DOCS: double reading is often ignored, the invitation letter seems to be not very explicit, they express fears or doubts concerning the reliability of centers or equipment for mammography, and fear of change center during the transition to the DOCS. The discrepancy between the date of letter reception and the realisation of their last mammography, the general aspect rather than individual aspect are important brakes in the DOCS. These elements could lead to actions to improve participation in the DOCS particular by involving more explicitly clinical physicians.PARIS12-CRETEIL BU Médecine (940282101) / SudocSudocFranceF

General Practitioner trainers prescribe fewer antibiotics in primary care: Evidence from France

Purpose: Antibiotic prescription is a central public health issue. Overall, 90% of antibiotic prescriptions are delivered to patients in ambulatory care, and a substantial proportion of these prescriptions could be avoided. General Practitioner (GP) trainers are similar to other GPs in terms of sociodemographic and medical activities, but they may have different prescription patterns. Our aim was to compare the antibiotic prescribing rates between GP trainers and non-trainers.Methods: This observational cross-sectional study was conducted on administrative data claims from the French National Health Insurance. The antibiotic prescribing rate was calculated. The main independent variable was the training status of the GPs. Prescribing rates were adjusted for the various GPs' characteristics (gender, age, location of the practice, number of visits per GP and the case-mix) in a multiple linear regression analysis.Results: Between June 2014 and July 2015 the prescribing patterns of 860 GPs were analysed, among which 102 were GP trainers (12%). Over the year 363,580 patients were prescribed an antibiotic out of 3,499,248 visits for 1,299,308 patients seen over the year thus representing around 27.5% of patients. In the multivariate analyses, being a trainer resulted in a significant difference of 6.62 percentage points (IC 95%: [-8.55; -4.69]; p<0.001) in antibiotic prescriptions comparing to being a non-trainer, corresponding to a relative reduction of 23.4%.Conclusion: These findings highlight the role of GP trainers in antibiotic prescriptions. By prescribing fewer antibiotics and influencing the next generations of GPs, the human and economic burden of antibiotics could be reduced

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

Background: SARS-CoV-2 has been responsible for a pandemic since the beginning of 2020. Vaccine arrival brings a concrete solution to fight the virus. However, vaccine hesitancy is high. In France, the first available vaccine was Comirnaty from Pfizer-BioNTech. Shared decision-making, based on tools such as patient decision aids (PtDAs), can help patients make an informed choice about vaccination with Comirnaty. Objective: The French College of Teachers in General Practice (CNGE) aimed to create a PtDA for people who have to decide whether they will receive the Comirnaty vaccine. Methods: Development of the PtDA was performed according to the International Patient Decision Aids Standards (IPDAS). The initial design was based on a literature review and semistructured interviews with 17 patients to explore and clarify patients' expectations. A first draft of the PtDA was then alpha tested by a patient expert group and a physician expert group. The PtDA was finally beta tested in 14 prevaccine consultations. A steering group was consulted throughout the work. Patient support, community groups and the French National Authority for Health (HAS) were involved in the development process. Results: A literature review identified one randomized trial on Comirnaty efficacy and safety. The first part of the PtDA allows patients to identify their own risk factors. The second part of the PtDA provides information on vaccination: benefits and risks, unknown data, and technical explanations about the mRNA vaccine. Conclusions: We developed a PtDA to be used in primary care settings for shared decision-making regarding vaccination with Comirnaty

L’approche centrée patient (ACP) : à propos d’une situation clinique en médecine générale

International audienc

Prescription of benzodiazepines and Z-drugs among older patients in primary care: a French, national, cohort study

Abstract Background In France, general practitioners (GPs) prescribe benzodiazepines and Z-drugs (BZD/ZDs) widely, and especially to older adults. Several characteristics of patients and/or GPs linked to BZD/ZD overprescription have been described in the general population but not among older patients in primary care. Objectives To estimate the proportion of GP consultations by patients aged 65 and over that resulted in a BZD/ZD prescription, and determine whether any GP-related factors predicted BZD/ZD overprescription in this setting. Methods We analyzed sociodemographic and practice-related GP characteristics, and aggregated data on consultations recorded prospectively by 117 GPs in a database between 2000 and 2010. Next, we used logistic regression models to look for factors potentially associated with BZD/ZD overprescription (defined as an above-median prescription rate). Results The GPs’ mean age at inclusion was 47.4 (7.1), and 87.9% were male. During the study period, the median (95% confidence interval) proportion of consultations with patients aged 65 and over resulting in a BZD/ZD prescription was 21.8% (18.1–26.1) (range per GP: 5–34.1%). In a multivariable analysis, a greater number of chronic disease (OR [95% CI] = 2.10 [1.22–3.64]), a greater number of drugs prescribed per consultation (5.29 [2.72–10.28]), and shorter study participation were independently associated with BZD/ZD overprescription. Conclusions BZD/ZD overprescription was associated with a greater chronic disease burden and the number of drugs prescribed per consultation but not with any sociodemographic or practice-related GP characteristics. Targeted actions are needed to help GPs limit their prescription of BZD/ZDs to older patients with multiple comorbidities and polypharmacy

Inappropriate direct oral anticoagulant prescriptions in patients with non-valvular atrial fibrillation: cross-sectional analysis of the French CACAO cohort study in primary care

International audienceBackground Direct oral anticoagulants (DOACs) account for an increasing proportion of prescriptions in patients with non-valvular atrial fibrillation (NVAF) in primary care. Inappropriate dosing of DOACs is a common problem, with under-dosing being a particular issue. However, conflicting results have been reported about the factors independently associated with inappropriate dosing. Aim To describe inappropriate prescriptions of DOACs among patients in the CACAO French nationwide general practice cohort, and to identify the factors independently associated with inappropriate DOAC doses. Design and setting Cross-sectional baseline analysis of the CACAO French national multicentre prospective cohort of adult patients in primary care receiving an oral anticoagulant who were recruited between April and October 2014. Method A total of 1111 patients from the CACAO cohort who received a DOAC for NVAF were included in this study. Inappropriate prescriptions of DOACs were described (inappropriate dosage, contraindications, non-indications, interactions, and non-compliance with the precautions for use). Multivariate logistic models were used to investigate factors associated with inappropriate DOAC dosing (under-dosing and over-dosing). Results Overall, 438 patients (39.4%) received at least one inappropriate DOAC prescription. The most common inappropriate prescription was inappropriate dosage ( n = 374, 33.7%), particularly under-dosing ( n = 348, 31.3%). Multivariate analysis revealed that factors independently associated with under-dosing were older age, prescription of apixaban or dabigatran, and a CHA2DS2-VASc score ≥2 vs. a score = 1. Factors with over-dosing were kidney failure, a HAS-BLED score ≥3, and older age. Conclusion The appropriateness of DOAC prescribing for NVAF can be improved, especially in older patients, and in patients with kidney failure, a higher risk of ischaemic stroke, and/or a higher risk of bleeding. GPs have a key role in increasing the proportion of appropriate DOAC prescriptions via informational, educational, and/or management strategies