Evaluating the impact of a standardised intervention for announcing decisions of withholding and withdrawing life-sustaining treatments on the stress of relatives in emergency departments (DISCUSS): protocol for a stepped-wedge randomised controlled trial.

INTRODUCTION: The decisions of withholding or withdrawing life-sustaining treatments are difficult to make in the context of emergency departments (EDs) because most patients are unable to communicate. Relatives are thus asked to participate in the decision-making process, although they are unprepared to face such situations. We therefore aimed to develop a standardised intervention for announcing decisions of withholding or withdrawing life-sustaining treatments in EDs and assess the efficacy of the intervention on the stress of relatives. METHODS AND ANALYSIS: The DISCUSS trial is a multicentre stepped-wedge cluster randomised study and will be conducted at nine EDs in France. A standardised intervention based on human simulation will be codesigned with partner families and implemented at three levels: the relatives, the healthcare professionals (HCP) and the EDs. The intervention will be compared with a control based on treatment as usual. A total of 538 families are planned to be included: 269 in the intervention group and 269 in the control group. The primary endpoint will be the symptoms of post-traumatic stress disorder (PTSD) at 90 days. The secondary endpoints will be symptoms of PTSD at 7 and 30 days, diagnosis of PTSD at 90 days and anxiety and depression scores at 7, 30 and 90 days. Satisfaction regarding the training, the assertiveness in communication and real-life stress of HCPs will be measured at 90 days. ETHICS AND DISSEMINATION: This study was approved by the ethics committee Est III from Nancy and the French national data protection authority. All relatives and HCPs will be informed regarding the study objectives and data confidentiality. Written informed consent will be obtained from participants, as required by French law for this study type. The results from this study will be disseminated at conferences and in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT06071078.

What are health professionals' perceptions and attitudes regarding children with early childhood caries and their families? A qualitative research protocol to assess oral health stigma in the medical setting.

INTRODUCTION: Dental caries is one of the most common non-communicable diseases in children. The disease management of caries relies on both a preventive individual approach (fluoridation, risk evaluation) and the surgical treatment of established carious lesions. Similar to other non-communicable diseases (obesity, mental diseases, etc), health professionals' negative perceptions of patients have been shown to affect the quality of disease management. Regarding dental caries in children, some data have indicated the presence of discriminating beliefs and behaviours towards these children and their families in the medical setting. However, oral health stigma related to dental care remains a largely unexplored issue. METHODS AND ANALYSIS: This study presents an exploratory research protocol focusing on the perceptions and attitudes of health professionals towards children with early childhood caries (ECC) and their parents. Semistructured interviews will be conducted among medical and dental health professionals, and verbatim quotations obtained from audio transcriptions will be analysed to identify health professionals' perceptions of ECC and the influence of these perceptions on clinical care for these children. ETHICS AND DISSEMINATION: The research ethics committee of the Department of Family Medicine at University Lyon 1 approved this protocol. The results will be published in peer-reviewed journals and presented at scientific meetings. TRIAL REGISTRATION NUMBER: NCT05284279.

Temporal Trend of Transient Ischemic Attack Management over a 10-Year Period: Data from the Rhône County, France.

BACKGROUND: Timely recognition and management of transient ischemic attack (TIA) offer the greatest opportunity to prevent subsequent stroke. But variability of TIA management quality exists across hospitals. Under the impetus of national plans, measures were adopted to improve TIA management, including a structured local pathway. Our objective was to compare TIA management between two periods over 10 years, before and after the implementation of these measures. METHODS: A before-and-after study was conducted with two identical population-based cohort studies in 2006-2007 (AVC69) and 2015-2016 (STROKE69) including all patients with TIA diagnosis over a 7-month period in six public and private hospitals in the Rhône county in France. The primary outcome was the adequate TIA management defined as brain and vessel imaging within 24 h of admission and the prescription of antithrombotic treatment at discharge. RESULTS: We identified 109 patients TIA patients in 2006-2007, and 458 over the same period in 2015-2016. A higher proportion of patients were adequately managed in 2015-2016 compared to 2006-2007 (14/96 [15%] in 2006-2007 vs. 306/452 [68%] in 2015-2016, p < 0.001). This difference was mainly driven by a marked increase of vessel imaging performed within 24 h of admission, most often by computed tomography angiography. Furthermore, patients called more often emergency medical dispatch before admission, were admitted with a shorter delay after symptom onset, and were more likely discharged to home in 2015-2016 compared to 2006-2007. CONCLUSION: Our study demonstrated an increasing rate of adequate TIA management, mainly driven by a marked increase of vessel imaging within 24 h of admission, over a 10-year period in the Rhône county in France.

Examining transcranial random noise stimulation as an add-on treatment for persistent symptoms in schizophrenia (STIM'Zo): a study protocol for a multicentre, double-blind, randomized sham-controlled clinical trial.

BACKGROUND: One out of three patients with schizophrenia failed to respond adequately to antipsychotics and continue to experience debilitating symptoms such as auditory hallucinations and negative symptoms. The development of additional therapeutic approaches for these persistent symptoms constitutes a major goal for patients. Here, we develop a randomized-controlled trial testing the efficacy of high-frequency transcranial random noise stimulation (hf-tRNS) for the treatment of resistant/persistent symptoms of schizophrenia in patients with various profiles of symptoms, cognitive deficits and illness duration. We also aim to investigate the biological and cognitive effects of hf-tRNS and to identify the predictors of clinical response. METHODS: In a randomized, double-blind, 2-arm parallel-group, controlled, multicentre study, 144 patients with schizophrenia and persistent symptoms despite the prescription of at least one antipsychotic treatment will be randomly allocated to receive either active (n = 72) or sham (n = 72) hf-tRNS. hf-tRNS (100-500 Hz) will be delivered for 20 min with a current intensity of 2 mA and a 1-mA offset twice a day on 5 consecutive weekdays. The anode will be placed over the left dorsolateral prefrontal cortex and the cathode over the left temporoparietal junction. Patients' symptoms will be assessed prior to hf-tRNS (baseline), after the 10 sessions, and at 1-, 3- and 6-month follow-up. The primary outcome will be the number of responders defined as a reduction of at least 25% from the baseline scores on the Positive and Negative Syndrome Scale (PANSS) after the 10 sessions. Secondary outcomes will include brain activity and connectivity, source monitoring performances, social cognition, other clinical (including auditory hallucinations) and biological variables, and attitude toward treatment. DISCUSSION: The results of this trial will constitute a first step toward establishing the usefulness of hf-tRNS in schizophrenia whatever the stage of the illness and the level of treatment resistance. We hypothesize a long-lasting effect of active hf-tRNS on the severity of schizophrenia symptoms as compared to sham. This trial will also have implications for the use of hf-tRNS as a preventive intervention of relapse in patients with schizophrenia. TRIAL REGISTRATION: ClinicalTrials.gov NCT02744989. Prospectively registered on 20 April 2016.

Stroke Care in Brazil and France: National Policies and Healthcare Indicators Comparison.

OBJECTIVE: To identify the commonalities and discrepancies between national health policies to combat stroke in France and Brazil. JUSTIFICATION: Both healthcare systems were structured as universal access and comprehensive care attention, hierarchized by the level of care, politically and administratively decentralized. France is an industrialized, high-income country, with health care involving copayment and reimbursement of expenses, and spontaneous demand for services. Brazil is a member of the BRICs, of upper middle income with totally free health care, with an active search for hypertension and diabetes in the general population. METHODS: Data regarding policies, risk factors, and health indicators about stroke care, from 2010 to 2017, were obtained from both countries (publicly accessible information or on request) from the respective Ministries of Health or international agencies. RESULTS: About acute stroke hospitalizations, on average, Brazil has 0.75 per 1000 annual population hospitalizations versus 1.54 per 1000 in France. Brazil has 0.21 per 1000 population deaths per year versus 0.40 per 1000 in France. The in-hospital mortality rate in Brazil has 139 per 1000 hospitalized people versus 263 in France. The average length of stay of acute hospitalizations was 7.6 days in Brazil versus 12.6 in France. The prevalence of strokes by age group shows from 0 to 39 years old (this rate is stable); 40-59 years (it is increasing in both countries); and 60-79 and 80+ years (this rate has been increasing in France and decreasing in Brazil). CONCLUSION: No major differences were found about the health policies and the National Health Plans related to stroke. However, the data directly linked to the period of hospitalization differed substantially between countries. Subsequent studies can be implemented to identify the explanatory factors, notably among the risk factors and actions in primary care, and the moments after hospital care, such as secondary prevention and palliative care.

Usefulness of repetitive transcranial magnetic stimulation as a maintenance treatment in patients with major depression.

OBJECTIVES: To investigate the clinical efficacy of repetitive transcranial magnetic stimulation (rTMS), venlafaxine or a combination of both treatments as a maintenance treatment in patients with treatment-resistant depression (TRD). METHODS: In a three-arm open-label study, 66 patients, including 45 remitters, who responded to rTMS (n = 25), venlafaxine (n = 22), or a combination of both treatments (n = 19) continued to receive the treatment that led to a response as a maintenance treatment over 12 months. Maintenance rTMS was administered twice per week for 1 month, once per week for 2 months, and once every 2 weeks for 9 months. Venlafaxine was maintained at the dose that induced a clinical response (150 or 225 mg/day). RESULTS: After the 12-month follow-up, the rates of remitters (HDRS < 8) were not different between the three groups (χ2 = 1.25; P = .3). The rates of patients who not relapsed (HDRS < 15) were not different between groups (χ2 = 0.33; P = .8): 40.0% in the rTMS group, 45.1% in the venlafaxine group and 36.9% in the combination group. CONCLUSIONS: The three maintenance approaches exhibited similar efficacies in relapse prevention and the maintenance of remission in patients with TRD.

Research protocol on early palliative care in patients with acute leukaemia after one relapse.

OBJECTIVES: According to the American Society of Clinical Oncology palliative care referrals are made within the last 3 weeks of patients' lives and most frequently when oncological treatments have ceased especially for patients with haematological malignancies. Recent publications indicate that patients with acute leukaemia are prone to symptoms, an indication for which a close collaboration between the patient's haematologist and a palliative care team might result in improved symptom management. The object of this pilot study is to evaluate the feasibility of a clinical research trial to assess the effect of early palliative care in patients with acute leukaemia after one relapse. METHODS: This project is a multicentre, non-blinded, randomised, controlled trial. Patients in group 1 will receive standard haematological care associated with palliative care (intervention group). Patients in group 2 will receive standard haematological care with palliative care only if requested by the haematologist (control group). In order to measure an accurate sample size, patients who participate will complete a standardised questionnaire to assess their quality of life, as well as their psychological and physical symptoms, before being randomised to one of two groups in a 1:1 ratio without stratified randomisation. RESULTS: The aim of this study is to analyse causes of dropout, non-adherence and missing data in order to refine the protocol for the subsequent clinical research trial. CONCLUSION: The ultimate objective of this project is to develop collaboration between haematologists and palliative care teams in order to improve patients' quality of life.

Mayo Adhesive Probability Score Is an Independent Computed Tomography Scan Predictor of Adherent Perinephric Fat in Open Partial Nephrectomy.

OBJECTIVE: To evaluate predictive radiological elements for adherent perinephric fat (APF) and the Mayo adhesive probability (MAP) score in the setting of open partial nephrectomy, and to assess their reproducibility. PATIENTS AND METHODS: We performed a retrospective case-control study involving 86 patients who had open partial nephrectomies performed by a single surgeon between January 1, 2009 and April 1, 2015. Radiological elements were assessed by 4 readers blinded to patient APF status. Univariate and multivariate analyses were performed for all radiological and clinical factors. Reproducibility was analyzed using agreement coefficients. RESULTS: On univariate analysis for radiological findings, lateral and posterior fat thickness (odds ratio [OR]: 1.084 [1.033, 1.138], P < .001), stranding (OR: 2.179 [1.431, 3.318], P < .001), -80 HU fat area, and the MAP score (OR: 1.797 [1.332, 2.424], P < .001) were predictive of APF. On multivariate analysis, only age and the MAP score remained statistically significant (OR: 1.060 [1.005, 1.118], P = .03; and OR: 1.560 [1.137, 2.139], P = .0058, respectively). The reproducibility of the MAP score was fair (AC1 = 0.367 and kappa F = 0.353), as was that of stranding (AC1 = 0.499, kappa F = 0.376). The agreement was important if we defined a "low" (0 to 3) or "high" (4 or 5) score (AC1 = 0.706 and kappa F = 0.681). CONCLUSION: The MAP score was the element that best predicted APF in our study, although its reproducibility among our readers was only fair. The agreement becomes important if we defined "low or high" score.

The efficacy and safety of low frequency repetitive transcranial magnetic stimulation for treatment-resistant depression: the results from a large multicenter French RCT.

CONTEXT: The aim of this study was to assess whether the combination of low frequency repetitive transcranial magnetic stimulation (rTMS) and venlafaxine (150-225 mg/day) is effective and safe for treatment-resistant unipolar depression (TRD). METHOD: In a multicenter (18 centers) randomized double blind controlled trial with three arms, 170 patients were allocated to receive active rTMS combined with active venlafaxine (n = 55), active rTMS combined with placebo venlafaxine (n = 60) or sham rTMS combined with active venlafaxine (n = 55). The patients received once daily sessions of active or sham 1 Hz rTMS applied over the right dorsolateral prefrontal cortex (360 pulses/day delivered at 120% of the resting motor threshold) for two to six weeks; rTMS was combined with active or sham venlafaxine (mean dose: 179.0 ± 36.6 mg/day). The primary outcome was the number of patients who achieved remission, which was defined as an HDRS17 score <8. RESULTS: We reported a similar significant antidepressant effect in the 3 groups (P < 10(-6)), with a comparable delay of action and a comparable number of remitters at the endpoint (28% in the combination group, 41% in the rTMS group and 43% in the venlafaxine group; P = 0.59). CONCLUSION: Low frequency rTMS appears to be as effective as venlafaxine and as effective as the combination of both treatments for TRD. Because of its short session duration (the duration of one session was 8.5 min) and its safety, slow rTMS might be a useful alternative treatment for patients with TRD.

Factors associated with adenoma detection rate and diagnosis of polyps and colorectal cancer during colonoscopy in France: results of a prospective, nationwide survey.

INTRODUCTION: Colonoscopy can prevent deaths due to colorectal cancer (CRC) through early diagnosis or resection of colonic adenomas. We conducted a prospective, nationwide study on colonoscopy practice in France. METHODS: An online questionnaire was administered to 2,600 French gastroenterologists. Data from all consecutive colonoscopies performed during one week were collected. A statistical extrapolation of the results to a whole year was performed, and factors potentially associated with the adenoma detection rate (ADR) or the diagnosis of polyps or cancer were assessed. RESULTS: A total of 342 gastroenterologists, representative of the overall population of French gastroenterologists, provided data on 3,266 colonoscopies, corresponding to 1,200,529 (95% CI: 1,125,936-1,275,122) procedures for the year 2011. The indication for colonoscopy was CRC screening and digestive symptoms in 49.6% and 38.9% of cases, respectively. Polypectomy was performed in 35.5% of cases. The ADR and prevalence of CRC were 17.7% and 2.9%, respectively. The main factors associated with a high ADR were male gender (p=0.0001), age over 50 (p=0.0001), personal or family history of CRC or colorectal polyps (p<0.0001 and p<0.0001, respectively), and positive fecal occult blood test (p=0.0005). The prevalence of CRC was three times higher in patients with their first colonoscopy (4.2% vs. 1.4%; p<0.0001). CONCLUSIONS: For the first time in France, we report nationwide prospective data on colonoscopy practice, including histological results. We found an average ADR of 17.7%, and observed reduced CRC incidence in patients with previous colonoscopy.

Survival advantage of hemodialysis relative to peritoneal dialysis in patients with end-stage renal disease and congestive heart failure.

Peritoneal dialysis (PD) has been proposed as a therapeutic option for patients with end-stage renal disease and associated congestive heart failure (CHF). Here, we compare mortality risks in these patients by dialysis modality by including all patients who started planned chronic dialysis with associated congestive heart failure and were prospectively enrolled in the French REIN Registry. Survival was compared between 933 PD and 3468 hemodialysis (HD) patients using a Kaplan-Meier model, Cox regression, and propensity score analysis. The patients were followed from their first dialysis session and stratified by modality at day 90 or last modality if death occurred prior. There was a significant difference in the median survival time of 20.4 months in the PD group and 36.7 months in the HD group (hazard ratio, 1.55). After correction for confounders, the adjusted hazard ratio for death in PD compared to the HD patients remained significant at 1.48. Subgroup analyses showed that the results were not changed with regard to the New York Heart Association stage, age strata, or estimated glomerular filtration rate strata at first renal replacement therapy. The use of propensity score did not change results (adjusted hazard ratio, 1.55). Thus, mortality risk was higher with PD than with HD among incident patients with end-stage renal disease and congestive heart failure. These results may help guide clinical decisions and also highlight the need for randomized clinical trials.

Risk factors for vitamin D deficiency in women aged 20-50 years consulting in general practice: a cross-sectional study.

OBJECTIVE: Vitamin D deficiency is often unidentified, although treatment is simple and inexpensive. Our objective was to estimate the influence of concealing clothes and other risk factors for vitamin D deficiency in women aged 20 to 50 years consulting general practitioners. METHODS: 13 GPs in the Rhone Alps area planned to recruit 300 women (100 veiled and 200 non-veiled) from January to March 2008. Serum 25(OH)D and PTH were measured in one single laboratory (Biomnis(®)) by a radio-immunoassay method. A survey was administered about dietary habits, sun exposure, and quality of life. RESULTS: Among 247 women enrolled, 196 were analysed: 61 wearing concealing clothes (31.2%) and 135 without (68.8%). As expected, 25(OH)D serum level was significantly lower in covered women (20.1 versus 38.9 nmol/l P < 0.001). Of women who did not wear concealing clothing, 39.3% had severe hypovitaminosis D (25(OH)D concentration < 30 nmol/l). Women wearing concealing clothes had more often other known risk factors such as dark skin (P < 0.001), less sunlight exposure, or a higher Body Mass Index (P = 0.009). Besides concealing clothing (OR 6.37, 95% CI: 1.35-30.09), multivariate analyses revealed two independent risk factors for vitamin D deficiency: no full-body sun exposure (OR: 3.06, 95% CI: 1.18-7.94) and no outdoor sports (OR: 2.81, 95% CI: 1.11-7.12) for threshold 52 nmol/l. CONCLUSION: Young women consulting their GP had hypovitaminosis D more often than expected. Besides concealing clothing, absence of full body sun exposure during summer and of outdoor sports practice could suggest a possible vitamin D deficiency.

Self-perception of quality of life by adolescents with neuromuscular diseases.

PURPOSE: Little is known about quality of life of adolescents with neuromuscular diseases or the factors that influence it. We searched whether physical impairment, physical disability, and medical complications were predictors of low quality of life. METHODS: Motor function, health, orthopedic status, and rehabilitation were assessed in 43 adolescents with neuromuscular diseases (mean age, 13.8 years, standard deviation 1.7 year; sex ratio 2.9/1). Quality of life was measured with the VSP-A ("Vécu Santé Perçu par l'Adolescent"; self-perceived health state in adolescents), a validated health-related quality of life self-perception test. A mixed linear regression related quality of life to impairment, disability, and respiratory status. Comparisons were made with results from an age/sex-matched nondisabled group. RESULTS: On the average, the VSP-A scores in physically disabled adolescents were: (1) similar to those of the nondisabled group with regard to vitality, body image, relationships with parents and friends, and physical and psychological well-being; (2) higher with regard to school performance (score 68 vs. 52.8) and relationships with teachers (67.4 vs. 43.2); and (3) lower with regard to leisure activities (43.9 vs. 60.9). Physical disability and physical impairment were not negatively associated with seven of the nine VSP-A dimensions, but physical impairment was negatively associated with leisure activities and vitality (p < .001 and p < .01, respectively). Adolescents with ventilatory support did not express lower scores than adolescents not requiring ventilatory support (67.7+/-11 vs. 62.9+/-15, p=.39). CONCLUSIONS: These surprising results should lead us question our medical, educational, and rehabilitation practices. Already well-managed disabled adolescents should benefit from less compassionate but more daring and dynamic interpersonal contacts.

Assessment of the 10-year probability of osteoporotic hip fracture combining clinical risk factors and heel bone ultrasound: the EPISEM prospective cohort of 12,958 elderly women.

This study aimed to develop a hip screening tool that combines relevant clinical risk factors (CRFs) and quantitative ultrasound (QUS) at the heel to determine the 10-yr probability of hip fractures in elderly women. The EPISEM database, comprised of approximately 13,000 women 70 yr of age, was derived from two population-based white European cohorts in France and Switzerland. All women had baseline data on CRFs and a baseline measurement of the stiffness index (SI) derived from QUS at the heel. Women were followed prospectively to identify incident fractures. Multivariate analysis was performed to determine the CRFs that contributed significantly to hip fracture risk, and these were used to generate a CRF score. Gradients of risk (GR; RR/SD change) and areas under receiver operating characteristic curves (AUC) were calculated for the CRF score, SI, and a score combining both. The 10-yr probability of hip fracture was computed for the combined model. Three hundred seven hip fractures were observed over a mean follow-up of 3.2 yr. In addition to SI, significant CRFs for hip fracture were body mass index (BMI), history of fracture, an impaired chair test, history of a recent fall, current cigarette smoking, and diabetes mellitus. The average GR for hip fracture was 2.10 per SD with the combined SI + CRF score compared with a GR of 1.77 with SI alone and of 1.52 with the CRF score alone. Thus, the use of CRFs enhanced the predictive value of SI alone. For example, in a woman 80 yr of age, the presence of two to four CRFs increased the probability of hip fracture from 16.9% to 26.6% and from 52.6% to 70.5% for SI Z-scores of +2 and -3, respectively. The combined use of CRFs and QUS SI is a promising tool to assess hip fracture probability in elderly women, especially when access to DXA is limited.