Outcome of patients with cystic fibrosis colonized by Scedosporium and Lomentospora species: A longitudinal cohort study.

Scedosporium and Lomentospora species rank second among the filamentous fungi colonizing the airways of cystic fibrosis (CF) patients. These fungi could be responsible for allergic bronchopulmonary mycosis (ABPM) and bronchitis before lung transplantation and invasive infections after. However, their role in CF lung disease is debated. This study aimed to identify clinical or environmental factors associated with an airway colonization by Scedosporium/Lomentospora species in patients with CF over a period of 7 years. A longitudinal cohort study was conducted from 2008 to 2014 in the CF reference centre in Lyon, France, to compare the characteristics of patients with Scedosporium/Lomentospora colonized and non-colonized patients. During the study period, 283 patients completed the clinical and microbiological follow-up. The analysis revealed that a higher number and duration of hospitalizations, an increased number of courses of parenteral antibiotic therapy, a history of ABPA, and treatment by itraconazole were significantly associated with an airway colonization by Scedosporium/Lomentospora species. The rate of decline of forced expiratory volume in the first second was not statistically different between colonized and non-colonized patients. This study provides evidence that patients colonized by Scedosporium/Lomentospora species require more medical care than non-colonized patients. Additional care could be in part explained by the management of Scedosporium/Lomentospora-related diseases such as ABPM or bronchitis. However, we did not demonstrate a faster rate of decline of respiratory function or body mass index in colonized patients, suggesting, as previously reported, that colonization of the airways by these fungi does not play a significant role in the progression of CF disease.

This prospective study did not demonstrate a faster rate of decline of respiratory function or body mass index in cystic fibrosis (CF) patients colonized by Scedosporium/Lomentospora species compared to non-colonized patients, suggesting that these fungi do not play a significant role in the progression of CF disease.

Impact of a nurse education programme on oral feeding in a neonatal unit.

BACKGROUND: Premature neonates often experience feeding difficulties during their hospital stay, and evidence-based interventions have been shown to improve feeding outcomes. AIM: This study investigated whether an infant-cue based nurse educational feeding bundle accelerates the achievement of independent oral feeding in neonates in a neonatal intensive care unit. STUDY DESIGN: A quality improvement study with a pre, during and post intervention test design. All premature neonates admitted to the unit were eligible. The feeding programme included a four-month nurse training module and nurse coaching. RESULTS: A hundred and twenty-five nurses or nurse assistants attended the programme and 706 neonates were included. The median time to independent oral feeding (IOF) was 40, 36 and 37 days, respectively, for pre, during and post intervention. The reduction in time to IOF observed during the post-intervention period compared with the baseline period was significant (HR = 1.32, CI 95%: 1.01-1.74). No difference was noted in the length of hospital stay between the three study periods. CONCLUSIONS: An infant-cue based nurse educational feeding bundle can promote earlier achievement of IOF in preterm neonates. RELEVANCE TO CLINICAL PRACTICE: This quality improvement study demonstrates the impact that a nurse-driven intervention in neonatal care can have on improving practice. Feeding interventions involve the early introduction of oral feeding, non-nutritive sucking (NNS), and oral motor stimulation, and should be individualized for each neonate. These individualized feeding interventions applied by all nurses and assistant nurses, can facilitate the achievement of earlier independent oral feeding in preterm infants and should be included in neonatal critical care nurse education programs.

Narrow-band imaging versus Lugol chromoendoscopy for esophageal squamous cell cancer screening in normal endoscopic practice: randomized controlled trial.

BACKGROUND: Narrow-band imaging (NBI) is as sensitive as Lugol chromoendoscopy to detect esophageal squamous cell carcinoma (SCC) but its specificity, which appears higher than that of Lugol chromoendoscopy in expert centers, remains to be established in general practice. This study aimed to prove the superiority of NBI specificity over Lugol chromoendoscopy in the detection of esophageal SCC and high grade dysplasia (HGD) in current general practice (including tertiary care centers, local hospitals, and private clinics). METHODS: This prospective randomized multicenter trial included consecutive patients with previous or current SCC of the upper aerodigestive tract who were scheduled for gastroscopy. Patients were randomly allocated to either the Lugol or NBI group. In the Lugol group, examination with white light and Lugol chromoendoscopy were successively performed. In the NBI group, NBI examination was performed after white-light endoscopy. We compared the diagnostic characteristics of NBI and Lugol chromoendoscopy in a per-patient analysis. RESULTS: 334 patients with history of SCC were included and analyzed (intention-to-treat) from 15 French institutions between March 2011 and December 2015. In per-patient analysis, sensitivity, specificity, positive and negative likelihood values were 100 %, 66.0 %, 21.2 %, and 100 %, respectively, for Lugol chromoendoscopy vs. 100 %, 79.9 %, 37.5 %, and 100 %, respectively, for NBI. Specificity was greater with NBI than with Lugol (P = 0.002). CONCLUSIONS: As previously demonstrated in expert centers, NBI was more specific than Lugol in current gastroenterology practice for the detection of early SCC, but combined approaches with both NBI and Lugol could improve the detection of squamous neoplasia.

Women's dissatisfaction with inappropriate behavior by health care workers during childbirth care in France: A survey study.

BACKGROUND: Quality care during childbirth requires that health care providers have not only excellent skills but also appropriate and considerate attitudes and behavior. Few studies have examined the proportion of women in Western countries expressing dissatisfaction with such inappropriate or inconsiderate behavior. This study evaluated this proportion in a sample presumably representative of French maternity units. METHODS: This prospective multicenter study, using data from a selfadministered questionnaire, took place in 25 French maternity units during one week in September 2018. The primary outcome measure was mothers' self-reported dissatisfaction with blatantly inappropriate behavior (ie, inappropriate attitude, inadequate respect for privacy, insufficient gentleness of care, and/or inappropriate language) by health care workers in the delivery room. The secondary outcome was their self-reported dissatisfaction with these workers' inconsiderate behavior (ie, unclear and inappropriate information, insufficient participation in decision-making, or deficient consideration of pain). RESULTS: Of 803 potentially eligible women, 627 completed the questionnaire after childbirth; 5.62% (35/623, 95% CI: 3.94-7.73) reported dissatisfaction with blatantly inappropriate behaviors and 9.79% (61/623, 95% CI: 7.57-12.40) with inconsiderate behaviors. The main causes of dissatisfaction reported by women in this survey were the inadequate consideration of their pain and the failure to share decision-making. CONCLUSIONS: Most of the women were satisfied with how health care workers behaved towards them in the delivery room. Nonetheless, health care staff must be aware of women's demands for greater consideration of their expressions of pain and of their voice in decisions.

Improving patient self-reporting of antihypertensive adverse drug events in primary care: a stepped wedge cluster randomised trial.

BACKGROUND: About 25% of patients experience adverse drug events (ADE) in primary care, but few events are reported by the patients themselves. One solution to improve the detection and management of ADEs in primary care is for patients to report them to their general practitioner. The study aimed to assess the effect of a booklet designed to improve communication and interaction between patients treated with anti-hypertensive drugs and general practitioners on the reporting of ADEs. METHODS: A cluster randomized controlled cross-sectional stepped wedge open trial (five periods of 3 months) was conducted. A cluster was a group of general practitioners working in ambulatory offices in France. Adults consulting their general practitioner to initiate, modify, or renew an antihypertensive prescription were included. A booklet including information on cardiovascular risks, antihypertensive treatments, and ADE report forms was delivered by the general practitioner to the patient in the intervention group. The primary outcome was the reporting of at least one ADE by the patient to his general practitioner during the three-month period after enrolment. Two clusters were randomised by sequence for a total of 8 to receive the intervention. An intention-to-treat analysis was conducted. A logistic mixed model with random intercept was used. RESULTS: Sixty general practitioners included 1095 patients (median: 14 per general practitioner; range: 1-103). More patients reported at least one ADE to their general practitioner in the intervention condition compared to the control condition (aOR = 3.5, IC95 [1.2-10.1], p = 0.02). The modification and initiation of an antihypertensive treatment were also significantly associated with the reporting of ADEs (aOR = 4.4, CI95 [1.9-10.0], p <  0.001 and aOR = 11.0, CI95 [4.6-26.4], p <  0.001, respectively). The booklet delivery also improved patient satisfaction on general practitioner communication and high blood pressure management. CONCLUSION: A booklet can improve patient self-reporting of ADEs to their general practitioners. Future research should assess whether it can improve general practitioner management of ADEs and patient's health status. TRIAL REGISTRATION: Trial registry identifier NCT01610817 (2012/05/30).

Un médiateur dans un service d'urgences hospitalières : quelles missions selon les personnels ?

OBJECTIVES: Violence in emergency services has become a central issue in the daily work of hospital employees. While the use of video surveillance and the training of professionals in conflict management are the most common methods used, there are few cases using the setting up of a third part such as a mediator. We conducted a qualitative study with professionals to examine their representations associated with mediation. METHOD: Semi-directive interviews were conducted with professionals from four emergency units. The topics discussed in interviews were the definition of mediation and the missions that the mediators should fulfil. The content of 38 semi-directive interviews was analysed according to the inductive approach of the grounded theory. A content analysis was made, followed by an analysis aiming to bring out types and convergences/divergences. RESULTS: Professionals were not aware of the definition of mediation and of its missions. They linked to it an instrumental theme, making mediation a tool for conflict prevention and management, a tool for communication with patients about their care, and about the organisation of emergency unit. The upcoming presence of mediators was seen as an help. A potential competition between professionals and mediators in the tasks performed was identified. CONCLUSION: The study shows a favourable opinion towards mediation. It has allowed to identify obstacles to the well-functioning of the missions assigned to mediators. One of the challenges is the integration of this new actor, the mediator.

Using ESDM 12 hours per week in children with autism spectrum disorder: feasibility and results of an observational study.

BACKGROUND: Early intervention for Autism Spectrum Disorder (ASD) in France is heterogeneous and poorly evaluated to date. Early Start Denver Model (ESDM) is a developmental and behavioral model of intervention for toddlers with ASD which has already shown very interesting outcomes on the development of children with ASD in various studies with different settings. However, it is not possible with the current research to agree on the best setting. Thus, we implemented an ESDM program according to our context where children are often pre-schooling early from 30 months old. This therapy was applied by a multidisciplinary team working in close collaboration with parents and other partners. SUBJECTS AND METHODS: A prospective observational study including 19 toddlers with ASD was conducted. We evaluated improvement on the cognitive level of toddlers with ASD receiving therapist-delivered ESDM intervention for 12 hours per week. RESULTS: Significant improvements in verbal and nonverbal cognitive skills at the Mullen Scale of Early Learning were obtained after 10 months of intervention in our sample. The largest improvement was in receptive language development quotient with a mean improvement of 19.6 points. We also observed promising outcomes in daily adaptive behavior, with a slight improvement in communication at the Vineland Adaptive Behavioral Scale. These outcomes, when compared to the conclusions of previous studies, are leading us to the need for a therapy duration beyond 10 months. CONCLUSIONS: Our outcomes were very encouraging even with low cognitive and nonverbal children. These outcomes may be confirmed in a multicenter randomized controlled trial that is ongoing.

[Mediators in emergency services: what missions according to the staff?] / Un médiateur dans un service d'urgences hospitalières : quelles missions selon les personnels ?

OBJECTIVES: Violence in emergency services has become a central issue in the daily work of hospital employees. While the use of video surveillance and the training of professionals in conflict management are the most common methods used, there are few cases using the setting up of a third part such as a mediator. We conducted a qualitative study with professionals to examine their representations associated with mediation. METHOD: Semi-directive interviews were conducted with professionals from four emergency units. The topics discussed in interviews were the definition of mediation and the missions that the mediators should fulfil. The content of 38 semi-directive interviews was analysed according to the inductive approach of the grounded theory. A content analysis was made, followed by an analysis aiming to bring out types and convergences/divergences. RESULTS: Professionals were not aware of the definition of mediation and of its missions. They linked to it an instrumental theme, making mediation a tool for conflict prevention and management, a tool for communication with patients about their care, and about the organisation of emergency unit. The upcoming presence of mediators was seen as an help. A potential competition between professionals and mediators in the tasks performed was identified. CONCLUSION: The study shows a favourable opinion towards mediation. It has allowed to identify obstacles to the well-functioning of the missions assigned to mediators. One of the challenges is the integration of this new actor, the mediator.

Impact of 2 generational improvements in colonoscopes on adenoma miss rates: results of a prospective randomized multicenter tandem study.

BACKGROUND AND AIMS: Numerous randomized studies have shown that changing certain features of colonoscopes, usually incorporated when switching from one endoscope generation to the next, mostly do not increase adenoma yield. There is, however, indirect evidence that it may be necessary to skip one instrument generation (ie, changing from one generation to the next but one) to achieve this effect. METHODS: We compared the latest-generation colonoscopes from one company (Olympus Exera III, 190-C) with the next to last one (Olympus 160/5-C) in a prospective multicenter study randomized for the order of colonoscopes in a tandem fashion, involving 2 different examiners. Patients with increased risk for colorectal neoplasia undergoing colonoscopy (positive fecal occult blood test, personal/familial history of colorectal cancer/adenoma, rectal bleeding, recent change in bowel movements) were included. The primary outcome was the adenoma miss rate with the 190 (190-C) colonoscope in comparison with the 160/5 colonoscope (160/5-C). RESULTS: A total of 856 patients (48.8% male; mean age, 58.3 years) with a personal (41%) or family (38%) history of colorectal neoplasia, rectal bleeding (19%), and other indications were included. Of the 429 patients in the 190-C first group, 16.6% (95% confidence interval [CI], 13.0%-20.1%) had at least one adenoma missed during the first procedure, compared with 30.2% (95% CI, 25.9%-34.6%) in the group with 160/5-C first (P < .001). Similarly, the adenoma detection rate during the first colonoscopy was 43.8% versus 36.5% (P = .030) for 190-C versus 160/5-C, respectively. CONCLUSIONS: This randomized tandem trial showed lower adenoma miss rates and higher adenoma detection rates for the newer 190 colonoscopes compared with the 160/5 series. These results suggest that it takes multiple improvements, such as those implemented over 2 instrument generations, before an effect on adenoma (miss) rate can be observed. (Study registration number: ISRCTN 2010-A01256-33.).

[Emergence of the patient-actor in patient safety in France. A narrative review in social sciences and public health]. / L'émergence du patient-acteur dans la sécurité des soins en France : une revue narrative de la littérature entre sciences sociales et santé publique.

INTRODUCTION: For the last forty years, patients have been encouraged to take part in their care and to participate in improving the quality and safety of care. This phenomenon requires reflection on the conditions of emergence of this new role and its public health implications, particularly in the field of patient safety. METHODS: A narrative review of the international literature was conducted by searching Medline, Cairn and Persée databases. RESULTS: The database query identified 2,206 documents, 106 of which were included in the analysis. The emergence of the patient-actor is linked to sanitary crises and promoted by patient associations in the field of patient safety such as le Lien. This movement induces a transformation of the patient's role beyond the theme of patient safety: it revolutionizes the patient's contribution to the health system. CONCLUSION: This narrative review of the literature highlights the way in which health crises have encouraged the emergence of a new actor: the patient-actor, accompanied by new semantics concerning the power of the patient. The patient occupies a specific place in the field of safety of care. In collaboration with healthcare professionals, the patient must constitute a resource to improve patient safety. The various contributions of patients are described and an analysis of the acceptability of patient participation is proposed.

Adenoma detection with blue-water infusion colonoscopy: a randomized trial.

Background and aims Colonoscopy is currently the reference method to detect colorectal neoplasia, yet some adenomas remain undetected. The water infusion technique and dying with indigo carmine has shown interesting results for reducing this miss rate. The aim of this study was to compare the adenoma detection rate (adenoma and adenocarcinoma; ADR) and the mean number of adenomas per patient (MAP) for blue-water infusion colonoscopy (BWIC) versus standard colonoscopy. Methods We performed a multicenter, randomized controlled trial in eight units, including patients with a validated indication for colonoscopy (symptoms, familial or personal history, fecal occult blood test positive). Consenting patients were randomized 1:1 to BWIC or standard colonoscopy. All colonoscopies were performed by experienced colonoscopists. All colonoscopy quality indicators were prospectively recorded. Results Among the 1065 patients included, colonoscopies were performed completely for 983 patients (514 men; mean age 59.1). The ADR was not significantly different between the groups; 40.4 % in the BWIC group versus 37.5 % in the standard colonoscopy group (odds ratio [OR] 1.13; 95 % confidence interval [CI] 0.87 - 1.48; P = 0.35). MAP was significantly greater in the BWIC group (0.79) than in the standard colonoscopy group (0.64; P = 0.005). For advanced adenomas, the results were 50 (10.2 %) and 36 (7.3 %), respectively (P = 0.10). The cecal intubation rate was not different but the time to cecal intubation was significantly longer in BWIC group (9.9 versus 6.2 minutes; P < 0.001). Conclusion Despite the higher MAP with BWIC, the routine use of BWIC does not translate to a higher ADR. Whether increased detection ultimately results in a lower rate of interval carcinoma is not yet known. CLINICAL TRIALS REGISTRATION: EudraCT 2012-A00548 - 35; NCT01937429.

Pregnancy outcome in women with cystic fibrosis-related diabetes.

INTRODUCTION: With increasing life expectancy, more women with cystic fibrosis and diabetes mellitus become pregnant. We investigated how pre-gestational diabetes (cystic fibrosis-related diabetes) influenced pregnancy outcome and the clinical status of these women. MATERIAL AND METHODS: We analyzed all pregnancies reported to the French cystic fibrosis registry between 2001 and 2012, and compared forced expiratory volume (FEV1 ) and body mass index before and after pregnancy in women with and without pre-gestational diabetes having a first delivery. RESULTS: A total 249 women delivered 314 infants. Among these, 189 women had a first delivery and 29 of these had pre-gestational diabetes. There was a trend towards a higher rate of assisted conception among diabetic women (53.8%) than non-diabetic women (34.5%, p = 0.06), and the rate of cesarean section was significantly higher in diabetic women (48% vs. 21.4%, p = 0.005). The rate of preterm birth and mean infant birthweight did not differ significantly between diabetic and non-diabetic women. Forced expiratory volume before pregnancy was significantly lower in the diabetic group. The decline in forced expiratory volume and body mass index following pregnancy did not differ between the women with and those without pre-gestational diabetes. CONCLUSION: Pre-gestational diabetes in women with cystic fibrosis is associated with a higher rate of cesarean section but does not seem to have a clinically significant impact on fetal growth or preterm delivery. The changes in maternal pulmonary and nutritional status following pregnancy in women with cystic fibrosis were not influenced by pre-gestational diabetes.

[The emergence of patient safety issues in France]. / L'émergence de la question de la sécurité des patients en France.

INTRODUCTION: The objective of this study was to elucidate the conditions of emergence of patient safety issues in the public debate and the limits to implementation of patient safety in the current health system. METHOD: A narrative review of the international literature was conducted by searching PubMed, Cairn and Persée databases. RESULTS: The database search retrieved 2,206 documents, 48 of which were included in the study. The theme of patient safety has spread worldwide, but emerged late in France. The delayed emergence of patient safety in France is essentially related to the euphemistic approach to the problem of patient safety, the difficulty of adopting systematic reasoning, the lack of human resources management levers and the ambiguous position of patients in relation to patient safety.

Randomized comparative evaluation of endoscopic submucosal dissection self-learning software in France and Japan.

Background and study aim: Endoscopic submucosal dissection (ESD) is currently the reference method to achieve an en bloc resection for large lesions; however, the technique is difficult and risky, with a long learning curve. In order to reduce the morbidity, training courses that use animal models are recommended. Recently, self-learning software has been developed to assist students in their training. The aim of this study was to evaluate the impact of this tool on the ESD learning curve. Methods: A prospective, randomized, comparative study enrolled 39 students who were experienced in interventional endoscopy. Each student was randomized to one of two groups and performed 30 ESDs of 30 mm standardized lesions in a bovine colon model. The software group used the self-learning software whereas the control group only observed an ESD procedure video. The primary outcome was the rate of successful ESD procedures, defined as complete en bloc resection without any perforation and performed in less than 75 minutes. Results: A total of 39 students performed 1170 ESDs. Success was achieved in 404 (70.9 %) in the software group and 367 (61.2 %) in the control group (P = 0.03). Among the successful procedures, there were no significant differences between the software and control groups in terms of perforation rate (22 [4.0 %] vs. 29 [5.1 %], respectively; P = 0.27) and mean (SD) procedure duration (34.1 [13.4] vs. 32.3 [14.0] minutes, respectively; P = 0.52). For the 30th procedure, the rate of complete resection was superior in the software group (84.2 %) compared with the control group (50.0 %; P = 0.01). Conclusion: ESD self-learning software was effective in improving the quality of resection compared with a standard teaching method using procedure videos. This result suggests the benefit of incorporating such software into teaching programs.

Impact of a transition nurse program on the prevention of thirty-day hospital readmissions of elderly patients discharged from short-stay units: study protocol of the PROUST stepped-wedge cluster randomised trial.

BACKGROUND: In France, for patients aged 75 or older, it has been estimated that the hospital readmission rate within 30 days is 14 %, a quarter being avoidable. Some evidence suggests that interventions "bridging" the transition from hospital to home and involving a designated professional (usually nurses) are the most effective in reducing the risk of readmission, but the level of evidence of current studies is low. Our study aims to assess the impact of a care transition program from hospital to home for elderly admitted to short-stay units. METHODS: This is a multicentre, stepped-wedge cluster randomised trial. The program will be implemented at three times of the transition: 1) during the patient's stay in hospital: development of a discharge plan, creation of a transitional care file, and notification of the primary care physician about inpatient care and hospital discharge by the transition nurse; 2) on the day of discharge: meeting between the transition nurse and the patient to review the follow-up recommendations; and 3) for 4 weeks after discharge: follow-up by the transition nurse. The primary outcome is the 30-day unscheduled hospital readmission or emergency visit rate after the index hospital discharge. The patients enrolled will be aged 75 or older, hospitalized in an acute care geriatric unit, and at risk of hospital readmission or an emergency visit after returning home. In all, 630 patients will be included over a 14-month period. Data analysis will be blinded to allocation, but due to the nature of the intervention, physicians and patients will not be blinded. DISCUSSION: Our study makes it possible to evaluate the specific effect of a bridging intervention involving a designated professional intervening before, during, and after hospital discharge. The strengths of the study design are methodological and practical. It permits the estimation of the intervention effect using between- and within-cluster comparisons; the study of the fluctuations in unscheduled hospital readmission or emergency visit rates; the participation of all clusters in the intervention condition; the implementation of the intervention in each cluster successively. TRIAL REGISTRATION: This study has been registered as a cRCT at clinicaltrials.gov (identifier: NCT02421133 ). Registered 9 March 2015.

Impact of a program to prevent incivility towards and assault of healthcare staff in an ophtalmological emergency unit: study protocol for the PREVURGO On/Off trial.

BACKGROUND: The emergency department has been identified as an area within the health care sector with the highest reports of violence. The best way to control violence is to prevent it before it becomes an issue. Ideally, to prevent violent episodes we should eliminate all triggers of frustration and violence. Our study aims to assess the impact of a quality improvement multi-faceted program aiming at preventing incivility and violence against healthcare professionals working at the ophthalmological emergency department of a teaching hospital. METHODS/DESIGN: This study is a single-center prospective, controlled time-series study with an alternate-month design. The prevention program is based on the successive implementation of five complementary interventions: a) an organizational approach with a standardized triage algorithm and patient waiting number screen, b) an environmental approach with clear signage of the premises, c) an educational approach with informational videos for patients and accompanying persons in waiting rooms, d) a human approach with a mediator in waiting rooms and e) a security approach with surveillance cameras linked to the hospital security. The primary outcome is the rate of incivility or violence by patients, or those accompanying them against healthcare staff. All patients admitted to the ophthalmological emergency department, and those accompanying them, will be enrolled. In all, 45,260 patients will be included in over a 24-month period. The unit analysis will be the patient admitted to the emergency department. Data analysis will be blinded to allocation, but due to the nature of the intervention, physicians and patients will not be blinded. DISCUSSION: The strengths of this study include the active solicitation of event reporting, that this is a prospective study and that the study enables assessment of each of the interventions that make up the program. The challenge lies in identifying effective interventions, adapting them to the context of care in an emergency department, and thoroughly assessing their efficacy with a high level of proof.The study has been registered as a cRCT at clinicaltrials.gov (identifier: NCT02015884).

A multifaceted risk management program to improve the reporting rate of patient safety incidents in primary care: a cluster-randomised controlled trial.

BACKGROUND: While patient safety incident reporting is of key importance for patient safety in primary care, the reporting rate by healthcare professionals remains low. This study aimed to assess the effectiveness of a risk management program in increasing the reporting rate within multiprofessional primary care facilities. METHODS: A nation-wide cluster-randomised controlled trial was performed in France, with each cluster defined as a primary care facility. The intervention included professional e-learning training, identification of a risk management advisor, and multidisciplinary meetings to address incident analysis. In the first observational period, a patient safety incident reporting system for professionals was implemented in all facilities. Then, facilities were randomised, and the program was implemented. Incidents were reported over the 15-month study period. Quasi-Poisson models were used to compare reporting rates. RESULTS: Thirty-five facilities (intervention, n = 17; control, n = 18) were included, with 169 and 232 healthcare professionals, respectively, involved. Overall, 7 out of 17 facilities carried out the entire program (41.2%), while 6 did not hold meetings (35.3%); 48.5% of professionals logged on to the e-learning website. The relative rate of incidents reported was 2.7 (95% CI = [0.84-11.0]; p = 0.12). However, a statistically significant decrease in the incident rate between the pre-intervention and post-intervention periods was observed for the control arm (HR = 0.2; 95% CI = [0.05-0.54]; p = 0.02), but not for the intervention arm (HR = 0.54; 95% CI = [0.2-1.54]; p = 0.23). CONCLUSION: This program didn't lead to a significant improvement in the patient safety incident reporting rate by professionals but seemed to sustain reporting over time. Considering that the program was fully implemented in only 41% of facilities, this highlights the difficulty of implementing such multidisciplinary programs in primary care despite its adaptation to the setting. A better understanding of how risk management is currently organized in these multiprofessional facilities is of key importance to improve patient safety in primary care. TRIAL REGISTRATIONS: The study has been registered at clinicaltrials.gov (NCT02403388) on 30 March 2015.

The challenge of adopting a collaborative information system for independent healthcare workers in France: a comprehensive study.

This study aimed to explore the perception of an underutilised collaborative information system through qualitative research, utilizing semi-structured, in-depth interviews with independent midwives and physician. PROSPERO, is a collaborative information system designed to bridge the communication gap between community-based healthcare workers and hospital-based care teams for parturients in Lyon, France. Through 27 semi-structured in-depth interviews with midwives, obstetricians, and general practitioners, we identified key themes related to the system's adoption: implementation challenges, utilisation barriers, interprofessional dynamics, and hidden variables affecting system use. Participants recognised the potential of PROSPERO to improve information sharing and care coordination but expressed concerns about the system's integration into existing workflows, time constraints, and the need for adequate training and technical support. Interprofessional dynamics revealed differing perspectives between hospital and independent practitioners, emphasising the importance of trust-building and professional recognition. Hidden variables, such as hierarchical influences and confidentiality concerns, further complicated the system's adoption. Despite the consensus on the benefits of a collaborative information system, its implementation was hindered by mistrust between healthcare workers (i.e. between independent practitioners and hospital staff). Our findings suggest that fostering trust and addressing the identified barriers are crucial steps towards successful system implementation. The study contributes to understanding the complex interplay of factors influencing the adoption of collaborative healthcare technologies and highlights the need for strategies that support effective interprofessional collaboration and communication.ClinicalTrials ID NCT02593292.

Impact of the presence of a mediator on patient violent or uncivil behaviours in emergency departments: a cluster randomised crossover trial.

BACKGROUND AND IMPORTANCE: Several studies reported that violent behaviours were committed by patients against healthcare professionals in emergency departments (EDs). The presence of mediators could prevent or resolve situations of tension. OBJECTIVE: To evaluate whether the presence of mediators in EDs would have an impact on violent behaviours committed by patients or their relatives against healthcare professionals. Design, settings and participants A 6-period cluster randomised crossover trial was performed in 4 EDs during 12 months. Patients aged ≥18 and their relatives were included. INTERVENTION: In order to prevent or resolve situations of tension and conflict, four mediators were recruited.Outcome measure and analysis Using a logistic regression mixed model, the rate of ED visits in which at least one act of violence was committed by a patient or their relatives, reported by healthcare professionals, was compared between the intervention group and the control group. RESULTS: A total of 50 429 ED visits were performed in the mediator intervention group and 50 851 in the control group. The mediators reported 1365 interventions; >50% of the interventions were to answer questions about clinical management or waiting time. In the intervention group, 173 acts of violence were committed during 129 ED visits, and there were 145 acts of violence committed during 106 ED visits in the control group. The rate of ED visits in which at least one act of violence was committed, was 0.26% in the intervention group and 0.21% in the control group (OR = 1.23; 95% CI [0.73-2.09]); on a 4-level seriousness scale, 41.6% of the acts of violence were rated level-1 (acts of incivility or rudeness) in the intervention group and 40.0% in the control group. CONCLUSION: The presence of mediators in the ED was not associated with a reduction in violent or uncivil behaviours committed by patients or their relatives. However, the study highlighted that patients had a major need for information regarding their care; improving communication between patients and healthcare professionals might reduce the violence in EDs. TRIAL REGISTRATION: Clinicaltrials.gov (NCT03139110).

Multifaceted intervention to enhance the screening and care of hospitalised malnourished children: study protocol for the PREDIRE cluster randomized controlled trial.

BACKGROUND: Hospital malnutrition is an underestimated problem and as many as half of malnourished patients do not receive appropriate treatment. In order to extend the management of malnutrition in health care facilities, multidisciplinary teams focusing on clinical nutrition were established in France. The establishment of such teams within hospital facilities remains nonetheless difficult. We have consequently developed a multifaceted intervention coordinated by a Nutritional Support Team (NST). Our study aims to evaluate the impact of this multifaceted intervention coordinated by a NST, in adherence to recommended practices for the care of malnourished children, among health care workers of a paediatric university hospital. METHODS/DESIGN: We carried out 1) a six-month observational phase focusing on the medical care procedures relative to malnourished children followed by 2) a cluster randomised controlled trial phase to evaluate the impact of a multidisciplinary nutrition team over an 18 month time frame.Based on power analyses and assuming a conservative intracluster correlation coefficient, 1289 children were needed to detect a 25% difference in rates between the two groups of the cluster trial.The implementation of our intervention was coordinated by the NST and had three major components: a) access to a computerised malnutrition screening system associated with an automatic alert system, b) an awareness campaign directed toward the health care workers and c) a leadership based strategy.Main outcomes included the number of daily weighings during hospitalisation, the investigation of malnutrition etiology and the management of malnutrition by a dietician and/or the NST.Due to the clustered nature of the data with children nested in departments, a generalized estimated equations approach will be used to analyse the impact of the multifaceted intervention on primary and secondary outcomes. DISCUSSION: Our results will provide an overall response regarding the effectiveness of our multifaceted intervention and we should be able to suggest an organization and mode of operation of NST. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01081587.