Patient-safety incidents during COVID-19 health crisis in France: An exploratory sequential multi-method study in primary care.

BACKGROUND: The COVID-19 pandemic has resulted in the rapid reorganisation of health and social care services. Patients are already at significant risk of healthcare-associated harm and the wholesale disruption to service delivery during the pandemic stood to heighten those risks. OBJECTIVES: We explored the type and nature of patient safety incidents in French primary care settings during the COVID-19 first wave to make tentative recommendations for improvement. METHODS: A national patient safety incident reporting survey was distributed to General Practitioners (GPs) in France on 28 April 2020. Reports were coded using a classification system aligned to the WHO International Classification for Patient Safety (incident types, contributing factors, incident outcomes and severity of harm). Analysis involved data coding, processing, iterative generation of data summaries using descriptive statistical analysis. Clinicaltrials.gov: NCT04346121. RESULTS: Of 132 incidents, 58 (44%) related to delayed diagnosis, assessments and referrals. Cancellations of appointments, hospitalisations or procedures was reported in 22 (17%) of these incidents. Home confinement-related incidents accounted for 13 (10%) reports and inappropriate medication stopping for five (4%). Patients delayed attending or did not consult their general practitioner or other healthcare providers due to their fear of contracting COVID-19 infection at an in-person visit in 26 (10%) incidents or fear of burdening their GPs in eight (3%) incidents. CONCLUSION: Constraints from the first wave of the COVID-19 pandemic have contributed to patient safety incidents during non-COVID-19 care. Lessons from these incidents pinpoint where primary care services in France can focus resources to design safer systems for patients

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

Targeted screening for melanoma after a 5-year follow-up: Comparison of melanoma incidence and lesion thickness at diagnosis in screened (versus unscreened) patients

Melanoma incidence and mortality rates are increasing worldwide. While screening appears to be inefficient, targeted screening might be effective. Objective: To assess the relative risk of developing a melanoma in a population that participated in targeted screening program compared with the general population. The secondary objective was to identify the factors related to melanoma thickness at the time of diagnosis. Design, setting, and participants: We assessed the incidence of melanoma from 2011 to 2015 in a cohort of 3832 patients at elevated risk of melanoma living on the west coast of France. The patients were older than 20 years, selected using the Self-Assessment of Melanoma risk score, and invited each spring to undergo a complete skin examination as part of a pilot targeted screening program for melanoma. Main outcome, measures: We calculated the relative risk of developing a melanoma, based on the comparison of melanoma incidence in patients who participated in the targeted screening and in the general population in the geographic area. Data collection was performed by the regional cancer registry, in accordance with international standards. Demographical variables and histological variables related to the identification of a thick melanoma (stage 2 and higher) were also analyzed. Results: 3 169 patients developed melanomas between April 2011 and December 2015. The relative risk of developing a melanoma during the five years of follow-up was 4.33 [4.17;4.50] in patients who participated in the pilot targeted screening program compared with the general population. The following factors were associated with the identification of thick melanomas: male gender (OR = 1.40; 95% CI [1.18−1.66]), age older than 75 years (OR = 1.72; 95% CI [1.38−2.14]), and residence in a rural area (OR = 1.48; 95% CI [1.21−1.80]). The targeted screening program did not lead to a lower proportion of thick melanomas at the time of diagnosis (OR=0.48 [0.11−1.40]). Conclusions and relevance: Targeted screening for melanoma allows general practitioners to focus their attention, energy, and time on at-risk populations with greater efficiency. However, participation in the pilot screening program was not associated with the identification of thinner melanomas at the time of diagnosis. Trial registration: This trial was registered in the Clinical Trials database before study enrollment commenced (ClinicalTrials.gov; Registration number: NCT01610531)

Anxiety, locus of control and sociodemographic factors associated with adherence to an annual clinical skin monitoring: a cross-sectional survey among 1000 high-risk French patients involved in a pilot-targeted screening programme for melanoma

International audienceOBJECTIVE:The aim of the study was to assess whether adherence to annual clinical skin monitoring is dependent on patient sociodemographic characteristics or personality traits.DESIGN:The study was a questionnaire survey.SETTING AND PARTICIPANTS:Data were collected between February and April 2013 in a sample of 1000 patients at high risk of melanoma who participated in a pilot-targeted screening programme in western France.OUTCOME MEASURES:Sociodemographic data, overall anxiety level (State-Trait Anxiety Inventory questionnaire), locus of control (Multidimensional Health Locus of Control scale) and levels of anxiety specifically associated with screening and melanoma were collected. Actual participation in the skin monitoring examination was reported by 78 general practitioner investigators.STATISTICAL ANALYSIS:Statistical analysis was performed using R statistical software. Factors associated with non-adherence were identified by multivariate analysis.RESULTS:Our analysis included 687 responses (526 adherent patients and 161 non-adherent patients). Non-adherence was higher in younger patients and in men (OR=0.63 (0.41-0.99)). Viewing health status as dependent on external persons (OR=0.90, 95% CI 0.83 to 0.97) or determined by chance (OR=0.89, 95% CI 0.80 to 0.98) and overall anxiety (OR=0.98, 95% CI 0.97 to 0.99) were also factors associated with non-adherence. In contrast, there was no link between anxiety specifically associated with the screening performed or melanoma and patient adherence to monitoring. Adherence was higher in married patients (OR=1.68 95% CI 1.08 to 2.60).CONCLUSIONS:The results of this study suggest that sociodemographic and psychological characteristics should be considered when including patients at elevated risk of melanoma in a targeted screening programme

Development and evaluation of a decision aid for women eligible for organized breast cancer screening according to international standards: A multi-method study

Backgroundand purpose:In France, women lack information to make a shared decision to start breast cancer screening. Decision aids are useful to facilitate this discussion, yet few meet international standards. The objective of this project was to build, validate and measure the quality of a decision aid for organized breast screening in France, in line with international standards, intended for both women and healthcare professionals.Materials and methodsThis mixed-methods study was conducted between January 2017 and June 2022. The prototype was developed from a qualitative study, systematic review and targeted literature review and alpha tested during two Delphi rounds. Readability was evaluated with the Flesch score and content with International Patient Decision Aid Standards Instrument (IPSASi).ResultsAn online decision aid, accessible at www.Discutons-mammo.fr, written in French was developed. The content included eligibility, information about breast screening the advantages and disadvantages of screening, patient preferences and a patient-based discussion guide using text, infographics, and videos. The Flesch readability test score was 65.4 and the IPDASi construct quality score was 176 out of 188.ConclusionsThis decision aid complies with IPDASi standards and could help women eligible for breast screening in France make a shared decision with a specialized healthcare professional about whether or not to participate in organized breast screening

Implementation of shared decision-making and patient-centered care in France: Towards a wider uptake in 2022

International audienceWe present the evolution of patient-centered care (PCC) and shared decision-making (SDM) in France since 2017, highlighting advantages and drawbacks of their implementation at the macro level. We then focus on several key policy and legislative milestones that are aimed to develop PCC and SDM. These milestones underline the importance of patient movements to support and fund the development of research and practice in the field. We shall conclude by presenting the growing research agenda and selected key topics. These key topics notably include the increase in both patient and healthcare professional trainings on PCC and SDM provided by healthcare users' and patients' representatives. PCC and SDM continue to be central preoccupations at the macro level, supported by public health policies and patients/healthcare users' actions. This overview, however, suggests that although implementation initiatives have increased since 2017, implementation remains scarce in routine clinical practice. Funding, not only for research projects, but for the implementation of PCC and SDM in real-life settings (e-decision aids, clinical guidelines integrating PCC/SDM, human resources dedicated to PCC/SDM, etc.) are needed to promote sustained adoption. More systematic training for both healthcare professionals and patients is also warranted for a true acculturation to occur