Reporting funding source or conflict of interest in abstracts of randomized controlled trials, no evidence of a large impact on general practitioners’ confidence in conclusions,...

Background: Systematic reporting of funding sources is recommended in the CONSORT Statement for abstracts. However, no specific recommendation is related to the reporting of conflicts of interest (CoI). The objective was to compare physicians’ confidence in the conclusions of abstracts of randomized controlled trials of pharmaceutical treatment indexed in PubMed. Methods: We planned a three-arm parallel-group randomized trial. French general practitioners (GPs) were invited to participate and were blinded to the study’s aim. We used a representative sample of 75 abstracts of pharmaceutical industry-funded randomized controlled trials published in 2010 and indexed in PubMed. Each abstract was standardized and reported in three formats: 1) no mention of the funding source or CoI; 2) reporting the funding source only; and 3) reporting the funding source and CoI. GPs were randomized according to a computerized randomization on a secure Internet system at a 1:1:1 ratio to assess one abstract among the three formats. The primary outcome was GPs’ confidence in the abstract conclusions (0, not at all, to 10, completely confident). The study was planned to detect a large difference with an effect size of 0.5. Results: Between October 2012 and June 2013, among 605 GPs contacted, 354 were randomized, 118 for each type of abstract. The mean difference (95% confidence interval) in GPs’ confidence in abstract findings was 0.2 (-0.6; 1.0) (P = 0.84) for abstracts reporting the funding source only versus no funding source or CoI; -0.4 (-1.3; 0.4) (P = 0.39) for abstracts reporting the funding source and CoI versus no funding source and CoI; and -0.6 (-1.5; 0.2) (P = 0.15) for abstracts reporting the funding source and CoI versus the funding source only. Conclusions: We found no evidence of a large impact of trial report abstracts mentioning funding sources or CoI on GPs’ confidence in the conclusions of the abstracts. Trial Registration: ClinicalTrials.gov identifier: NCT0167987

Reporting funding source or conflict of interest in abstracts of randomized controlled trials, no evidence of a large impact on general practitioners' confidence in conclusions, a three-arm randomized controlled trial.

ClinicalTrials.gov identifier: NCT01679873International audienceBACKGROUND: Systematic reporting of funding sources is recommended in the CONSORT Statement for abstracts. However, no specific recommendation is related to the reporting of conflicts of interest (CoI). The objective was to compare physicians' confidence in the conclusions of abstracts of randomized controlled trials of pharmaceutical treatment indexed in PubMed. METHODS: We planned a three-arm parallel-group randomized trial. French general practitioners (GPs) were invited to participate and were blinded to the study's aim. We used a representative sample of 75 abstracts of pharmaceutical industry-funded randomized controlled trials published in 2010 and indexed in PubMed. Each abstract was standardized and reported in three formats: 1) no mention of the funding source or CoI; 2) reporting the funding source only; and 3) reporting the funding source and CoI. GPs were randomized according to a computerized randomization on a secure Internet system at a 1:1:1 ratio to assess one abstract among the three formats. The primary outcome was GPs' confidence in the abstract conclusions (0, not at all, to 10, completely confident). The study was planned to detect a large difference with an effect size of 0.5. RESULTS: Between October 2012 and June 2013, among 605 GPs contacted, 354 were randomized, 118 for each type of abstract. The mean difference (95% confidence interval) in GPs' confidence in abstract findings was 0.2 (-0.6; 1.0) (P = 0.84) for abstracts reporting the funding source only versus no funding source or CoI; -0.4 (-1.3; 0.4) (P = 0.39) for abstracts reporting the funding source and CoI versus no funding source and CoI; and -0.6 (-1.5; 0.2) (P = 0.15) for abstracts reporting the funding source and CoI versus the funding source only. CONCLUSIONS: We found no evidence of a large impact of trial report abstracts mentioning funding sources or CoI on GPs' confidence in the conclusions of the abstracts.Trial Registration: ClinicalTrials.gov identifier: NCT01679873

Exclusion of patients with concomitant chronic conditions in ongoing randomised controlled trials targeting 10 common chronic conditions and registered at ClinicalTrials.gov: a systematic review of registration details

International audienceObjectives To systematically assess registration details of ongoing randomised controlled trials (RCTs) targeting 10 common chronic conditions and registered at ClinicalTrials.gov and to determine the prevalence of (1) trial records excluding patients with concomitant chronic condition(s) and (2) those specifically targeting patients with concomitant chronic conditions.Design Systematic review of trial registration records.Data sources ClinicalTrials.gov register.Study selection All ongoing RCTs registered from 1 January 2014 to 31 January 2015 that assessed an intervention targeting adults with coronary heart disease (CHD), hypertension, heart failure, stroke/transient ischaemic attack, atrial fibrillation, type 2 diabetes, chronic obstructive pulmonary disease, painful condition, depression and dementia with a target sample size ≥100.Data extraction From the trial registration records, 2 researchers independently recorded the trial characteristics and the number of exclusion criteria and determined whether patients with concomitant chronic conditions were excluded or specifically targeted.Results Among 319 ongoing RCTs, despite the high prevalence of the concomitant chronic conditions, patients with these conditions were excluded in 251 trials (79%). For example, although 91% of patients with CHD had a concomitant chronic condition, 69% of trials targeting such patients excluded patients with concomitant chronic condition(s). When considering the co-occurrence of 2 chronic conditions, 31% of patients with chronic pain also had depression, but 58% of the trials targeting patients with chronic pain excluded patients with depression. Only 37 trials (12%) assessed interventions specifically targeting patients with concomitant chronic conditions; 31 (84%) excluded patients with concomitant chronic condition(s).Conclusions Despite widespread multimorbidity, more than three-quarters of ongoing trials assessing interventions for patients with chronic conditions excluded patients with concomitant chronic conditions

‘Intern life’: a longitudinal study of burnout, empathy, and coping strategies used by French GPs in training

Background: More than half of French medical GP trainees (GPTs) suffer from burnout. Aim: To define and follow the evolution of risk factors, such as empathy and coping strategies, associated with burnout in this population. Design & setting: Prospective longitudinal study involving volunteers of 577 Parisian university GPTs in 2012. Method: Self-reported anonymous online questionnaires were sent three times every 6 months to all participants. Stress was measured using the Intern-Life scale and burnout using the Maslach Inventory, and anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS). Sociodemographic, professional, and personal data, including coping strategies and measures of empathy were also collected. Results: In total 343 questionnaires were fully completed at baseline (T0): 304 were usable at baseline, 169 were usable at 6 months (T1) and 174 at 1 year (T2). Stress rates decreased sharply between T1 (scores 42.96) and T2 (17.08), while scores for burnout remained relatively stable: more than 13% of GPTs had high scores in all three dimensions of burnout. Depersonalisation increased from 61% (T1) to 66% (T2). One hundred and four paired samples were analysed between T0 and T1, and between T1 and T2. Emotion-centred coping was associated with emotional exhaustion (P<0.05), while professional support reduced it. Experiences of aggression increased depersonalisation (P<0.05). Social support, problem-centred coping, perspective-taking empathy, and professional support improved the sense of personal accomplishment (P<0.05). Conclusion: Tools to help GPTs are available but are underused. More training in doctor–patient relationships and understanding of medical hidden curricula are necessary to decrease burnout among GPTs and improve their wellbeing and patient care

Personality traits are associated with cognitive empathy in medical students but not with its evolution and interventions to improve it

International audienceObjectiveCognitive empathy might decrease during medical school. Factors associated with its evolution remain poorly understood, as well as whether such factors could moderate the effect of an intervention to preserve cognitive empathy. The aim was to explore the associations between personality traits and both cognitive empathy at baseline and its changes at follow-up. The possible effect of an intervention depended upon personality traits was also examined.MethodsThe cohort consisted of fourth year medical students and the associations between personality traits, using the Short Big Five Inventory, and cognitive empathy changes at 3-month, using the Jefferson Scale of Empathy-Student version (JSE-S), were examined. A randomization in two groups (Balint groups versus no intervention) allowed examining whether the effect of the intervention depended upon personality traits. Linear regressions were adjusted for gender, anticipated specialty choice, parental education, living status, financial insecurity, randomization group and baseline JSE-S.ResultsThe cohort included 311 participants from October 2015 to December 2016 at Paris Diderot and Paris Descartes University. At follow-up, there was a JSE-S total score increase of 1.22(SD:9.10) in the intervention group, compared to a decrease of 1.64(SD:10.74) in the other group. Baseline JSE-S was positively associated with Extraversion and Conscientiousness and negatively with Neuroticism. In contrast, we found no associations between baseline personality traits and JSE-S change. There were no interactions between personality traits and randomization group.ConclusionAlthough personality might be linked with cognitive empathy, medical students may benefit from strategies designed for improving cognitive empathy regardless of their personality

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

International audienceBackground: 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