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

Task interruptions from the perspective of work functions: The development of an observational tool applied to inpatient hospital care in France The Team'IT tool.

BackgroundIn France, hospital units responsible for providing inpatient care have few opportunities to address the issue of task interruptions. In Australia, the Dual Perspectives Method (DMP) has been developed to assess interruptions. The method makes it possible to link teamwork and interruptions, by considering the work functions that constitute the system.ObjectiveTo develop a tool that can characterize interruptions from the point of view of work functions that is tailored to French hospital units providing inpatient care. The aim was to adapt the items recorded using the DPM and their response categories, and to study the acceptability of observing interruptions for participating teams.MethodThe items recorded in the DPM were translated and adapted taking into account the French definition of interruptions. This step identified 19 items that targeted the interrupted professional, and 16 that targeted the interrupting professional. The characteristics of interruptions were recorded in September 2019 among 23 volunteer teams in a region in western France. Two observers simultaneously observed the same professional. Observations lasted seven consecutive hours, and targeted all professional categories within the same team.ResultsThe characteristics of 1,929 interruptions were noted. The observation period was well-received by teams. The following terminology regarding the work functions of the interrupting professional was clarified: "coordination of institutional resources", in relation to "the establishment's support processes", "patient services", and "the patient's social life". We believe that our categorization of response modes is exhaustive.ConclusionsWe have developed an observational tool, Team'IT, which is tailored to inpatient hospital care in France. Its implementation is the first step in a system to support teams in managing interruptions, and will enable them to reflect on their working methods, and whether interruptions can be avoided. Our work is part of an approach that seeks to improve and enhance the safety of professional practices, by contributing to the longstanding, complex debate about the flow and effectiveness of patient care.Trial registrationClinicalTrials.gov NCT03786874 (December 26, 2018)

Task interruptions from the perspective of work functions: The development of an observational tool applied to inpatient hospital care in France The Team’IT tool

Background In France, hospital units responsible for providing inpatient care have few opportunities to address the issue of task interruptions. In Australia, the Dual Perspectives Method (DMP) has been developed to assess interruptions. The method makes it possible to link teamwork and interruptions, by considering the work functions that constitute the system. Objective To develop a tool that can characterize interruptions from the point of view of work functions that is tailored to French hospital units providing inpatient care. The aim was to adapt the items recorded using the DPM and their response categories, and to study the acceptability of observing interruptions for participating teams. Method The items recorded in the DPM were translated and adapted taking into account the French definition of interruptions. This step identified 19 items that targeted the interrupted professional, and 16 that targeted the interrupting professional. The characteristics of interruptions were recorded in September 2019 among 23 volunteer teams in a region in western France. Two observers simultaneously observed the same professional. Observations lasted seven consecutive hours, and targeted all professional categories within the same team. Results The characteristics of 1,929 interruptions were noted. The observation period was well-received by teams. The following terminology regarding the work functions of the interrupting professional was clarified: “coordination of institutional resources”, in relation to “the establishment’s support processes”, “patient services”, and “the patient’s social life”. We believe that our categorization of response modes is exhaustive. Conclusions We have developed an observational tool, Team’IT, which is tailored to inpatient hospital care in France. Its implementation is the first step in a system to support teams in managing interruptions, and will enable them to reflect on their working methods, and whether interruptions can be avoided. Our work is part of an approach that seeks to improve and enhance the safety of professional practices, by contributing to the longstanding, complex debate about the flow and effectiveness of patient care. Trial registration ClinicalTrials.gov NCT03786874 (December 26, 2018)

What is the level of safety culture in French nursing homes? The EHPAGE study

International audienceBackground: French nursing homes (NHs) are in the early stages of implementing their risk management approach. The latter includes the development of a safety culture (SC) among professionals. A training package to support NHs in implementing a risk management strategy has been designed by QualiREL Santé, a regional body that provides support in quality and risk management. The aim is to improve SC. No data are available about the level of SC in French NHs. This study evaluates the level of SC and identifies predictors of SC scores in NHs that will subsequently benefit from the training package. Method: The study was proposed to NHs who are members of QualiREL Santé in 2 French departments. Inclusion criteria were voluntary participation, the commitment of top management to benefit from the training package, and the absence of previous risk management support provided by QualiREL Santé. The NHSOPS-F questionnaire (22 items measuring 7 dimensions of SC) was administered to professionals between January and March 2016. 14 variables related to the structural profile of the NHs and the strategic choices of top management in terms of healthcare safety were recorded. Scores for 7 dimensions were calculated for all of the included NHs. Further modelling identified predictive factors. Results: 58 NHs were included. The response rate for the NHSOPS-F (n = 1946 professionals) was 64% (Q1-Q3 = [49.4;79.0]). Staffing was the least-developed dimension (11.8%), while scores were highest for Feedback and communication about incidents (84.8%). Being attached to a public hospital was associated with poorer perceptions of SC, notably for the dimension "Overall perceptions of resident safety and organizational learning" (β = − 19.59;p-value< 0.001). A less-developed SC was also significantly linked to existing Quality initiatives. Conclusions: Overall, French NHs must prioritise issues of staffing, teamwork and compliance with procedures. The role of human factors within teams should be exploited by top management. Our initial findings will help to adapt improvement approaches and are particularly relevant to local and national policies during the ongoing pandemic

Incidence of Adverse Events Associated with Technical Care and Support in French Nursing Homes: The EHPAGE Project

International audienceA rise in the number of dependent elderly people has made nursing homes an important part of the French health system. Through the struggle against adverse events associated with treatments, the question of the residents' safety and wellbeing has been paramount. To get an estimation of the highest incidence rates of adverse events in nursing homes, we carried out a follow-up study on 536 residents over 15-day periods between November 2016 and May 2017 in 8 French nursing homes. Notifications by professionals coupled with explorations by an investigating physician helped evidence the different typologies and degrees of seriousness of treatment-related adverse events. The 149 treatment-related adverse events that were identified belonged to 13 risk domains. Four of these domains accounted for 60% of treatment-related adverse events: 'medication and medical provision', 'living environment', 'technical care and accompaniment', 'care organization and coordination'. Four treatment-related adverse events out of the 149 (2.7%) had a level of seriousness rated as 4; 16 (10.7%) had a seriousness level rated as 3. Finally, particular attention should be paid to suicide risk. These first results need to be corroborated, but they will help develop messages of prevention aimed at professionals

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Cervical cancer screening uptake: A randomized controlled trial assessing the effect of sending invitation letters to non-adherent women combined with sending their general practitioners a list of their non-adherent patients (study protocol)

International audienceIntroduction Cervical cancer (CC) is the fourth most common cancer among women. It can be cured if diagnosed at an early stage and treated promptly. The World Health Organization suggests that 70% of women should be screened with a high-performance test by the age of 35. This paper reports a protocol to assess the effect of two modalities of organized CC screening programmes on CC screening uptake. Methods and analysis Design and setting: The design involves a 3-arm randomized controlled study performed in a French geographic area on the west coast. A total of 1,395 general practitioners will be randomized, depending on their general practice surgeries. Participants: The design is based on a total of 94,393 women aged 40 to 65 years who are eligible for CC screening. Intervention: In the “optimized cancer screening” group, the intervention will combine sending invitation letters to non-adherent women with sending general practitioners (GPs) a list of their non-adherent patients. In the “standard cancer screening” group, the intervention will be limited to sending invitation letters to non-adherent women. In the “usual care” group, no letter will be sent either to women or to their GPs. Primary endpoint: CC screening test uptake will be assessed after a 6-month follow-up period. Statistical analysis: The percentage of women who are up-to-date with their screening at 6 months after the intervention will be compared across arms using a generalized mixed linear model. Discussion A large-scale randomized trial of this nature is unprecedented. The study will enable us to assess a strategy relying on GPs, identified as the coordinators in this screening strategy. The study results should help policy makers to implement organized CC screening programs in the future. Ethics and dissemination The study was approved was approved by the Ethics Committee of the National College of Teaching General practitioners (IRB00010804). It was recorded in ClinicalTrials.gov on the number NCT04689178 (28 December 2020). The study findings will be used for publication in peer-reviewed scientific journals and presentations in scientific meetings

Transcultural adaptation and psychometric study of the French version of the nursing home survey on patient safety culture questionnaire

International audienceBACKGROUND:The Nursing Home Survey on Patient Safety Culture (NHSOPS) questionnaire was developed by the Agency for Healthcare Research and Quality (AHRQ), particularly as an intervention to raise staff awareness about patient safety issues. The main objective of the present study was to provide a validated French-language measure of the safety culture (SC) in nursing homes. Thus the aim was i) to carry out a transcultural adaptation into French of the NHSOPS questionnaire, ii) to assess its psychometric properties in a sample of professionals working in French EHPAD facilities and iii) to develop our own tool.METHODS:The study was carried out on volunteering professionals from 61 nursing homes (from January to March 2016). Two phases were conducted: an initial phase involving the translation and cultural adaptation of the questionnaire, and a second phase in which the psychometric properties of the questionnaire were assessed. A Structural Equation Model (SEM) with a maximum likelihood estimation method was used to evaluate the construct validity of the questionnaire. As the fit of the structure was not sufficient, an exploratory factor analysis using a principal axis factoring with an oblique rotation was then performed. Internal consistency was evaluated and we examined test-retest reliability using Intra-class Correlation Coefficients (ICC).RESULTS:During the initial phase, all items were retained and minor adjustments were made. The participation rate by professionals was 58.4%. The exploratory analysis led to the identification of seven dimensions: Teamwork, Staffing, Compliance with procedures, Handoffs, Feedback and communication about incidents, Supervisor expectations and actions promoting resident safety, Overall perceptions of resident safety and Organizational learning. The SEM confirmed the existence of the seven latent dimensions (CFI = 0.946; TLI = 0.933; SRMR = 0.059; RMSEA = 0.061); internal consistency was acceptable. ICC per item ranged from 0.19 to 0.88.CONCLUSIONS:The results from this study were robust on seven dimensions. This French version is the first on Patient SC to have been applied to the medical-social sector caring for dependent elderly people in France. The NHSOPS questionnaire provides the opportunity to broach this subject. A national evaluation campaign should provide the opportunity to confirm or improve this measure.TRIAL REGISTRATION:NCT02908373 (September 21, 2016) «Retrospectively registered»

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