Efficacy and safety of oral corticosteroids to treat outpatients with acute exacerbations of COPD in primary care: a multicentre pragmatic randomised controlled study.

Aim: To compare prednisone and placebo for the treatment of outpatients treated for acute exacerbations of chronic obstructive pulmonary disease (COPD) in a primary care setting. Methods: A multicentre, parallel, double-blind, pragmatic randomised controlled trial was performed in France. A total of 66 general practitioners included patients aged ≥40 years with cumulative smoking of ≥10 pack-years and a diagnosis of certain or likely acute exacerbation of COPD. Oral prednisone (40 mg) or placebo were administered daily for 5 days. The main outcome was treatment failure at 8 weeks, defined as a composite criterion based on the occurrence of at least one of the following: unplanned visit to an emergency department or to a practitioner in the ambulatory setting, hospital admission or death. The planned sample size was 202 patients per group. Results: 175 patients were included from February 2015 to May 2017 (43% of the planned sample). All-cause 8-week treatment failure rate was 42.0% in the prednisone group and 34.5% in the placebo group (relative risk 1.22, 95% CI 0.87-1.69, p=0.25). Respiratory-related 8-week treatment failure rate was 27.6% in the prednisone group and 13.6% in the placebo group (relative risk 2.00, 95% CI 1.15-3.57, p=0.015). Conclusion: Although the planned sample size was not achieved, the study does not suggest that oral corticosteroids are more effective than placebo for the treatment of an acute exacerbation of COPD in a primary care setting.

Balint groups and narrative medicine compared to a control condition in promoting students' empathy.

BACKGROUND: The perceived importance of clinical empathy may decline among students during medical training. Several interventions have been shown to be effective in promoting or preserving medical students' empathic abilities, such as empathy skills training or Balint groups. Although narrative medicine training shares some features with these interventions, no randomized study to date examined the efficacy of narrative medicine training. This study aimed to assess the effects of Balint groups and narrative medicine training on clinical empathy measured by the self-rated Jefferson's School Empathy Scale - Medical Student (JSPE-MS©) among fourth-year medical students. METHODS: Students who gave their consent to participate were randomly allocated in equal proportion to Balint groups, narrative medicine training or to the control group. Participants in the intervention groups received either seven sessions of 1.5-h Balint groups or a 2-h lecture and five sessions of 1.5-h narrative medicine training from October 2015 to December 2015. The main outcome was the change in JSPE-MS© score from baseline to one week after the last session. RESULTS: Data from 362 out of 392 participants were analyzed: 117 in the control group, 125 in the Balint group and 120 in the narrative medicine group. The change in JSPE-MS© score from baseline to follow-up was significantly higher in the Balint group than in the control group [mean (SD): 0.27 (8.00) vs. -2,36 (11.41), t = 2.086, P = 0.038]. The change in JSPE-MS© score in the narrative medicine group [mean (SD): - 0.57 (8.76)] did not significantly differ from the changes in the control group (t = 1.355, P = 0.18) or the Balint group (t = 0.784, P = 0.43). Adjusting for participants' characteristics at baseline, Balint groups remained associated with better outcomes compared to the control group (ß = 2.673, P = 0.030). CONCLUSIONS: Balint groups may promote clinical empathy to some extent among medical students, at least in the short run.

Promoting empathy among medical students: A two-site randomized controlled study.

OBJECTIVE: To assess the effects of Balint groups on empathy measured by the Consultation And Relational Empathy Measure (CARE) scale rated by standardized patients during objective structured clinical examination and self-rated Jefferson's School Empathy Scale - Medical Student (JSPE-MS©) among fourth-year medical students. METHODS: A two-site randomized controlled trial were planned, from October 2015 to December 2015 at Paris Diderot and Paris Descartes University, France. Eligible students were fourth-year students who gave their consent to participate. Participants were allocated in equal proportion to the intervention group or to the control group. Participants in the intervention group received a training of 7 sessions of 1.5-hour Balint groups, over 3months. The main outcomes were CARE and the JSPE-MS© scores at follow-up. RESULTS: Data from 299 out of 352 randomized participants were analyzed: 155 in the intervention group and 144 in the control group, with no differences in baseline measures. There was no significant difference in CARE score at follow-up between the two groups (P=0.49). The intervention group displayed significantly higher JSPE-MS© score at follow-up than the control group [Mean (SD): 111.9 (10.6) versus 107.7 (12.7), P=0.002]. The JSPE-MS© score increased from baseline to follow-up in the intervention group, whereas it decreased in the control group [1.5 (9.1) versus -1.8 (10.8), P=0.006]. CONCLUSIONS: Balint groups may contribute to promote clinical empathy among medical students. TRIAL REGISTRATION: NCT02681380.

Bacterial resistance in urinary tract infections in patients with diabetes matched with patients without diabetes.

BACKGROUND: With bacterial resistances having increased, patients with diabetes who are at higher risk of urinary tract infection (UTI) need to be studied. The study aim was to compare bacterial resistances to ofloxacin, cefixim, co-trimoxazole, nitrofurantoin and fosfomycin in UTI between patients with and without diabetes. METHODS: A cross-sectional study was conducted in ambulatory laboratories, including patients over 18 coming for urinalyses. Patients with diabetes were matched with two patients without diabetes based on risk factors for UTI using a propensity score. RESULTS: Among 1119 patients with UTI, 124 patients with diabetes were matched with 246 patients without diabetes. In patients with diabetes, the bacteria identified were: Escherichia coli (71%), Klebsiella (6%), Staphylococcus (5%), Enterococcus (4%), Proteus (2%) and Pseudomonas (1%); these findings were similar to those found in patients without diabetes. Resistances to ofloxacin and cefixim regardless of the bacteria were increased in patients with diabetes after matching on age, sex and history of UTI (respectively: OR=2.09; p=0.04 and OR=3.67; p=0.05). Regarding E. coli resistance, there was no difference whatever the antibiotic. CONCLUSION: The increased ofloxacin and cefixim resistance in patients with diabetes should be considered when prescribing probabilistic antibiotics, and could lead to changes in first-line treatments in UTI.

Impact of a Doctor's Invitation on Participation in Colorectal Cancer Screening: A Cluster Randomized Trial.

BACKGROUND: There is a need to improve participation in colorectal cancer screening. Our objective was to assess the impact of a signature from the patient's general practitioner on a letter inviting patients to participate in a colorectal cancer screening. METHOD: We conducted a cluster randomized controlled trial with 57 general practitioners established in Paris for more than 5 years, randomized to intervention or usual-care arms. There were 3422 patients included, ages 50-74 years, from general practitioner patient files, and eligible for an invitation letter or a reminder letter to participate in the national population-based screening program. In the intervention arm, patients received a standard letter signed by their general practitioner inviting them to visit the general practitioner's office for a fecal occult blood test if they were eligible. Control patients received the standard invitation letter or the standard reminder. All letters were sent by the district screening organization. The main outcome was the proportion of patients who took the fecal occult blood test within 6 months after the invitation. RESULTS: Among patients eligible for the study, 508 (14.8%) took a fecal occult blood test after being invited; 285 (15%; 95% confidence interval [CI], 13.5-16.7) in the intervention group and 223 (14.6%; 95% CI, 12.9-16.5) in the control group, with no statistical difference between the 2 groups (odds ratio 1.04; 95% CI, 0.83-1.31; P = .731). CONCLUSIONS: The addition of a general practitioner's signature to a standard letter inviting patients to take a fecal occult blood test had no impact on the frequency of patients taking the fecal occult blood test in the Paris program of colorectal cancer screening.

Suspected community-acquired pneumonia in an ambulatory setting (CAPA): a French prospective observational cohort study in general practice.

BACKGROUND: Few studies have addressed the pragmatic management of ambulatory patients with suspected community-acquired pneumonia (CAP) using a precise description of the disease with or without chest X-ray (X-ray) evidence. AIMS: To describe the characteristics, clinical findings, additional investigations and disease progression in patients with suspected CAP managed by French General Practitioners (GPs). METHODS: The patients included were older than 18 years, with signs or symptoms suggestive of CAP associated with recent-onset unilateral crackles on auscultation or a new opacity on X-ray. They were followed for up to 6 weeks. Descriptive analyses of all patients and according to their management with X-rays were carried out. RESULTS: From September 2011 to July 2012, 886 patients have been consulted by 267 GPs. Among them, 278 (31%) were older than 65 years and 337 (38%) were at increased risk for invasive pneumococcal disease. At presentation, the three most common symptoms, cough (94%), fever (93%), and weakness or myalgia (81%), were all observed in 70% of patients. Unilateral crackles were observed in 77% of patients. Among patients with positive radiography (64%), 36% had no unilateral crackles. A null CRB-65 score was obtained in 62% of patients. Most patients (94%) initially received antibiotics and experienced uncomplicated disease progression regardless of their management with X-rays. Finally, 7% of patients were hospitalised and 0.3% died. CONCLUSIONS: Most patients consulting GPs for suspected CAP had the three following most common symptoms: cough, fever, and weakness or myalgia. More than a third of them were at increased risk for invasive pneumococcal disease. With or without X-rays, most patients received antibiotics and experienced uncomplicated disease progression.

Evidence of Bordetella pertussis infection in adults presenting with persistent cough in a french area with very high whole-cell vaccine coverage.

Although France has had a vaccination program for 40 years, since 1990, an increase in whooping cough cases with parent-infant transmission has been observed. This study prospectively assessed the frequency of Bordetella pertussis infection in adults who consulted general practitioners for a persistent cough without an evident diagnosis. Among 217 patients, 70 (32%) confirmed whooping cough cases were identified. One case was culture positive, 36 were polymerase chain reaction positive, and 40 had increases or decreases of > or =2-fold in anti-pertussis toxin IgG titer between serum samples collected during the acute and convalescent phases. The median duration of cough in confirmed cases was 49 days (range, 13-123 days). Of the patients, 60% reported vaccination, and 33% reported whooping cough in infancy. Pertussis should be considered for diagnosis of acute and chronic cough in adults. Future studies should evaluate the public health interest of booster doses of pertussis vaccine in adults.