Compliance with the pregnancy prevention program among women initiating isotretinoin treatment between 2014 and 2021: A nationwide cohort study on the French Health Data System (SNDS).

BACKGROUND: Despite the French pregnancy prevention program (PPP), a considerable number of pregnancies are potentially exposed to oral isotretinoin. New measures were taken by the French Medicines Agency, including the restriction of initial isotretinoin prescriptions to dermatology specialists in May 2015 and a new information campaign on teratogenicity in January 2019. OBJECTIVES: The aims were to: describe, between 2014 and 2021, compliance with PPP recommendations: isotretinoin use as a second-line treatment, first prescription by a dermatology specialist, monthly prescription renewal and pregnancy testing (PT); assess the effect of the 2015 and 2019 measures on PT compliance; and identify the determinants of PT noncompliance. METHODS: A retrospective cohort study was conducted among women aged 11-50 years initiating isotretinoin between 2014 and 2021 using the French Health Data System. PT compliance corresponded to pregnancy test completion and specific delays between prescription and dispensation. Time series analyses were performed to evaluate the effect of the 2015 and 2019 measures on PT compliance, and log-binomial and Poisson multivariate regression models were used to identify the determinants of PT noncompliance. RESULTS: Isotretinoin was prescribed as a second-line treatment in 64% of initiations, mainly by dermatology specialists (92%). A new monthly prescription was observed in 98% of dispensations. PT compliance reached 61%, 72% and 25% at initiation, renewals and end of treatment, respectively. The 2015 measure was associated with better PT compliance at initiation and renewals. The 2019 measure had no significant effect on PT compliance at the initiation or end of treatment but was associated with a decrease in PT compliance at renewals. Age, low socioeconomic level, initiation by a nondermatology specialist and during summer were associated with PT noncompliance. CONCLUSIONS: Understanding factors associated with PT noncompliance could help to target specific subpopulations of women treated with isotretinoin.

[Patient safety culture for health professionals in primary care : French adaptation of the MOSPSC questionnaire (Medical Office Survey on Patient Safety Culture)]. / Culture de sécurité des professionnels de santé en soins primaires : adaptation en langue française du questionnaire MOSPSC (« Medical Office Survey on Patient Safety Culture ¼).

BACKGROUND: Patient safety culture (PSC) takes into account a number of individual and organizational factors. Evaluation of PSC with the participation of primary health care professionals can be carried out through self-administered surveys such as the AHRQ's Medical Office Survey on Patient Safety Culture (MOSPSC) questionnaire. AIM: To translate the MOSPSC questionnaire into French, while analyzing its psychometric properties. METHODS: The MOSPSC questionnaire was first translated into French, with linguistic analysis included, and then back-translated into English, in accordance with the ISPOR recommendations. Lastly, the French version of the MOSPSC questionnaire was completed by health professionals from 36 outpatient structures. Study of the psychometric properties (test-retest, Cronbach's α, and factor analysis) was conducted based on the professionals' responses. RESULTS: After linguistic analysis, the notion of "team" was translated in the final questionnaire as "structure". This term was used in the pilot survey of 415 professionals. The participation rate was 64.1% (266/415); 51.9% (138/415) were paramedics (mainly nurses and physiotherapists). The Cronbach coefficient α inclusive of all dimensions was 0.94. A "reporting of safety incidents" dimension was added, and the "staff training" dimension was merged with "development and standardization of office processes", bringing to 13 the number of dimensions identified after factor analysis. CONCLUSIONS: Having been adapted and validated, the French version of the questionnaire can be used as a tool for assessment of PSC in France. It should not only facilitate the monitoring of PSC in primary care facilities, but also prove conducive to comparison of PSC evolution in different establishments. Lastly, it Could contribute to national and international research on risk management in primary care.

Factors contributing to patient safety incidents in primary care: a descriptive analysis of patient safety incidents in a French study using CADYA (categorization of errors in primary care).

BACKGROUND: Patient safety incidents (PSIs) frequently occur in primary care and are often considered to be preventable. Better knowledge of factors contributing to PSIs is required to build safer care. The aim of this work was to describe the underlying factors, specifically the human factors, that are associated with PSIs in primary care using CADYA ("CAtégorisation des DYsfonctionnements en Ambulatoire" or "Categorization of Errors in Primary Care"). METHODS: We followed a mixed method with content analysis and coding in CADYA of PSIs reported in the ESPRIT study, a French cross-sectional survey of primary care. For each incident, a main contributing factor (MD) and, if applicable, a secondary contributing factor (SD) were identified. Several descriptive keywords from an incremental glossary have been suggested to describe each identified human factor (attitudes or behaviours). A descriptive statistical analysis was then conducted. RESULTS: Among the 482 PSIs reported in the ESPRIT study, from 13,438 acts reported by 127 participating general practitioners (GPs), we identified 590 contributing factors (482 MDs and 178 SDs). Overall, 35% were related to the care process, 30% to human factors, 22% to the healthcare environment and 13% to technical factors. The contributing factors, in decreasing order of frequency, were communication errors (13.7%), human factors related to healthcare providers (12.9%) and human factors related to patients (12.9%). The human factors were mainly related to 'lack of attention', 'stress', 'anger' and 'fatigue'. CONCLUSIONS: Our results tend to prove that human factors are often involved in PSIs in primary care, with GPs and patients being equally responsible. Beyond the identification of communication errors, often found in other international research, we have described the attitudes and behaviours contributing to unsafe care. Further research exploring the links between working conditions and human factors is required.

Assessment of patient safety culture: what tools for medical students?

BACKGROUND: The assessment of patient safety culture refers mainly to surveys exploring the perceptions of health professionals in hospitals. These surveys have less relevance when considering the assessment of the patient safety culture of medical students, especially at university or medical school. They are indeed not fully integrated in care units and constitute a heterogeneous population. This work aimed to find appropriate assessment tools of the patient safety culture of medical students. METHODS: Systematic review of the literature. Surveys related to a care unit were excluded. A typology of the patient safety culture of medical students was built from the included surveys. RESULTS: Eighteen surveys were included. In our typology of patient safety culture of medical students (15 dimensions), the number of dimensions explored by survey (n) ranged from 1 to 12, with 6 "specialized" tools (n ≤ 4) and 12 "global" tools (N ≥ 5). These surveys have explored: knowledge about patient safety, acknowledgment of the inevitability of human error, the lack of skills as the main source of errors, the errors reporting systems, disclosure of medical errors to others health professionals or patients, teamwork and patient involvement to improve safety in care. CONCLUSIONS: We recommend using Wetzel's survey for making an overall assessment of the patient safety culture of medical students at university. In a specific purpose-e.g. to assess an educational program on medical error disclosure-the authors recommend to determine which dimensions of patient safety will be taught, to select the best assessment tool. Learning on patient safety should however be considered beyond the university. International translations of tools are required to create databases allowing comparative studies.

[Which definition and taxonomy of incident to use for a French reporting system in primary care settings?]. / Quelle définition et taxonomie utiliser pour un recueil d'événements indésirables associés aux soins primaires en France?

BACKGROUND: There is no widely accepted definition of incident for primary care doctors in France and no taxonomic classification system for epidemiological use. In preparation for a future epidemiological study on primary care incidents in France (the ESPRIT study), this work was designed to identify the definitions and taxonomic classifications used internationally along with the usual methods and results in terms of frequency in the literature. The goal was to determine a French definition and taxonomy. DESIGN: Systematic review of the literature and consensus methods. METHOD: An exhaustive search of epidemiological surveys was performed. A structured grid was used. After having identified the definitions used in the literature, a definition was chosen using the focus groups method. Taxonomies identified in the literature were classified by relationship, architecture, code number, and number of studies published. Subsequently, a consensus among experts, who independently tested these taxonomies on six incidents, was reached for choosing the most appropriate for epidemiological data collection (little information on a large number of cases). RESULTS: Twenty-four papers reporting 17 studies were selected among 139 articles. Five definitions and eight taxonomies were found. The chosen definition of incident was based on the WHO definition "A patient safety incident is an event or circumstance that could have resulted, or did result, in harm to a patient, and whose wish it is not repeated again". The test of incidents resulted in the choice of the TAPS version of the International Taxonomy of Medical Error in Primary Care for a reproducible and internationally recognized codification and the tempos method for its current use in French general practice. DISCUSSION: The definitions, taxonomies, data collection characteristics and frequency of incidents results in the international literature on incidents in primary care are key components for the preparation of an epidemiological survey on incidents in primary care.