The French HSOPSC questionnaire showed acceptable psychometric properties. Classification of the dimensions should guide future development of safety culture improving action plans.

BackgroundThe study objectives were to describe the incidence and the nature of patient safety incidents (PSIs) in primary care general practice settings, and to explore the association between these incidents and practice or organizational characteristics.MethodsGPs, randomly selected from a national influenza surveillance network (n = 800) across France, prospectively reported any incidents observed each day over a one-week period between May and July 2013. An incident was an event or circumstance that could have resulted, or did result, in harm to a patient, which the GP would not wish to recur. Primary outcome was the incidence of PSIs which was determined by counting reports per total number of patient encounters. Reports were categorized using existing taxonomies. The association with practice and organizational characteristics was calculated using a negative binomial regression model.Results127 GPs (participation rate 79%) reported 317 incidents of which 270 were deemed to be a posteriori judged preventable, among 12,348 encounters. 77% had no consequences for the patient. The incidence of reported PSIs was 26 per 1000 patient encounters per week (95% CI [23‰ -28‰]). Incidents were three times more frequently related to the organization of healthcare than to knowledge and skills of health professionals, and especially to the workflow in the GPs’ offices and to the communication between providers and with patients. Among GP characteristics, three were related with an increased incidence in the final multivariable model: length of consultation higher than 15 minutes, method of receiving radiological results (by fax compared to paper or email), and being in a multidisciplinary clinic compared with sole practitioners.ConclusionsPatient safety incidents (PSIs) occurred in mean once every two days in the sampled GPs and 2% of them were associated with a definite possibility for harm. Studying the association between organizational features of general practices and PSIs remains a major challenge and one of the most important issues for safety in primary care.

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BackgroundAlthough many organizational culture questionnaires have been developed, there is a lack of any validated multidimensional questionnaire assessing organizational culture at hospital ward level and adapted to health care context. Facing the lack of an appropriate tool, a multidisciplinary team designed and validated a dimensional organizational culture questionnaire for healthcare settings to be administered at ward level.MethodsA database of organizational culture items and themes was created after extensive literature review. Items were regrouped into dimensions and subdimensions (classification validated by experts). Pre-test and face validation was conducted with 15 health care professionals.In a stratified cluster random sample of hospitals, the psychometric validation was conducted in three phases on a sample of 859 healthcare professionals from 36 multidisciplinary medicine services: 1) the exploratory phase included a description of responses’ saturation levels, factor and correlations analyses and an internal consistency analysis (Cronbach’s alpha coefficient); 2) confirmatory phase used the Structural Equation Modeling (SEM); 3) reproducibility was studied by a test-retest.ResultsThe overall response rate was 80 %; the completion average was 97 %. The metrological results were: a global Cronbach’s alpha coefficient of 0.93, higher than 0.70 for 12 sub-dimensions; all Dillon-Goldstein’s rho coefficients higher than 0.70; an excellent quality of external model with a Goodness of Fitness (GoF) criterion of 0.99. Seventy percent of the items had a reproducibility ranging from moderate (Intra-Class Coefficient between 50 and 70 % for 25 items) to good (ICC higher than 70 % for 33 items).ConclusionsCOMEt (Contexte Organisationnel et Managérial en Etablissement de Santé) questionnaire is a validated multidimensional organizational culture questionnaire made of 6 dimensions, 21 sub-dimensions and 83 items. It is the first dimensional organizational culture questionnaire, specific to healthcare context, for a unit level assessment showing robust psychometric properties (validity and reliability). This tool is suited for research purposes, especially for assessing organizational context in research analysing the effectiveness of hospital quality improvement strategies. Our tool is also suited for an overall assessment of ward culture and could be a powerful trigger to improve management and clinical performance. Its psychometric properties in other health systems need to be tested.Electronic supplementary materialThe online version of this article (doi:10.1186/s12913-016-1736-4) contains supplementary material, which is available to authorized users.

Background: Chlamydia trachomatis can lead to a persistent infection in the lower gastrointestinal tract, suggesting a potential role of autoinoculation of cervical chlamydial infection from the rectal site, contributing to repeat infections. Moreover, around 75% of women with urogenital C. trachomatis have concurrent anorectal infection. Current treatment guidelines for urogenital C. trachomatis infection recommend either a single 1 g dose of azithromycin or doxycycline 100 mg twice daily for 7 days. Doxycycline appears to be more effective in treating anorectal infections as suggested in a population of men who have sex with men, but no randomized controlled trial (RCT) had directly compared azithromycin with doxycycline for the treatment of rectal infections. We propose an open-label RCT to compare the microbial cure obtained with a single 1 g dose of azithromycin versus 100 mg of doxycycline twice daily for 7 days, for the treatment of anorectal C. trachomatis infection concurrent to urogenital infection in women. Methods and study design: A total of 460 women with C. trachomatis urogenital infection will be enrolled in the study. Women will be asked to provide self-collected anorectal swabs and will be randomized to receive either a 1 g single dose of azithromycin or doxycycline 100 mg twice daily for 7 days. Clinical and biological data will be collected and patients will complete questionnaires about their sexual behavior. The primary outcome is the microbial cure rate, defined as a C. trachomatis negative nucleic acid amplification test (NAAT) result in the anorectal specimens 6 weeks after treatment initiation among women with a C. trachomatis positive urogenital and anorectal NAAT result at the baseline. The secondary outcome is autoinoculation from the rectum to the vagina, which will be evaluated based on the number of women with the same C. trachomatis genotype profile that will be identified in an anorectal-positive specimen obtained 6 weeks after treatment initiation and in a vaginal-positive specimen obtained four months after treatment. Discussion: The results of this trial will establish which treatment is more efficacious against anorectal infection and could affect recommendations for the treatment of urogenital C. trachomatis infection, taking into account concurrent anorectal infection. Trial registration numbers: EudraCT number: 2017-002595-15. ClinicalTrials.gov Identifier: NCT03532464. Date of registration: May 31, 2018. World Health Organisation International Clinical Trials Registry: NTC03532464. Secondary ID: CHUBX 2016/26. Date of registration: May 09, 2018.

BackgroundStroke is a health problem with serious consequences, both in terms of mortality, and after-effects affecting patient quality of life. Stroke requires both urgent and chronic management involving the entire health care system. Although large variability in the management of stroke patients have been noticed, knowledge of the diversity and the scalability of post-stroke pathways, whether it is the care pathway or the life pathway, is currently not sufficient. Moreover the link between post-stroke pathways and patients sequelae have not been yet clearly defined. All this information would be useful to better target the needs to improve stroke patient management.The purposes are to identify the post-stroke life pathways components associated with sequelae (activity limitations – main purpose, cognitive disorders, anxio-depressive disorders, fatigue, participation restrictions) at 3 months and 1 year post-stroke, to define a typology of life pathways of patients during the post-stroke year and to analyze the social and geographical inequalities in the management of stroke.MethodsDesign: a prospective multicenter comparative cohort study with a follow up to 1 year after the acute episode.Participant centers: 13 hospitals in the Aquitaine region (France).Study population: patients diagnosed with a confirmed ischemic or hemorrhagic stroke included in the Aquitaine Observatory of Stroke (ObA2) cohort and voluntary to participate.Data sources are existing databases (ObA2 database and the French National Health Data System - SNDS) to collect information about care pathways, patient characteristics and stroke characteristics and Ad hoc surveys to collect information about life pathways and post-stroke sequelae. The endpoints of the study are post-stroke activity limitations evaluated by the modified Rankin score, other post-stroke sequelae (Cognitive disorders, anxio-depressive disorders, fatigue, restriction of participation) assessed by standardized and validated scales and Clusters of patients responding to pathways with common or similar characteristics.;DiscussionBy integrating a longitudinal dimension and relying on a large cohort, the project will make it possible to identify the sources of disturbances and the factors favorable to the outcome of the life pathways, important for the planning of the offer and the management of the public policies concerning stroke pathways.Trial registrationClinicalTrials.gov ID: NCT03865173, March 6th, 2019.

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IntroductionThe appropriateness of oral anticoagulant prescriptions is a major challenge to improve quality and safety of care. As indicators of the appropriateness of oral anticoagulant prescriptions are lacking, the aim of the study is to develop and validate a panel of such indicators, in hospitalised adults, from the hospital information system of two university hospitals in France.Methods and analysisThe study will be carried out in four steps: (1) a literature review to identify indicators of the appropriateness of oral anticoagulant prescriptions and their conditions of appropriateness; (2) a Delphi consensus method to assess the potential utility and operational implementation of the selected indicators; (3) techniques of medical data search to implement indicators from the hospital information system and; (4) a cross-sectional study to assess the ability of indicators to detect inappropriate oral anticoagulant prescriptions, performance of medical data search techniques for tracking or retrieving information and the ability of tools to be transferred into other institutions. The fourth step will include up to 80 patient hospital stays for each indicator, depending on the prevalence of inappropriate prescriptions estimated in interim analyses.Ethics and disseminationThis work addresses the current lack of quality indicators of the appropriateness of oral anticoagulant prescriptions. We aim to develop and validate such indicators for integrating them into hospital clinical practice, as part of a structured approach to improve quality and safety of care. As each hospital information system is different, we will propose tools transferable to other healthcare institutions to allow an automated construction of these indicators. The PACHA study protocol was approved by institutional review boards and ethics committees (CPP Sud-Ouest et Outre Mer III—DC 2016/119; CPP Ile-de-France II—CDW_2016_0014).Registration detailsClinical Trial.gov registration: NCT02898090.