[COVID-19 and medical publications: How three articles have influenced the media and public decisions in France]. / Littérature médicale et COVID-19 : comment trois articles ont influencé les médias et la décision publique en France.

The present article details the publication process and the vicissitudes of three articles about SARS-CoV-2 and its related disease (COVID-19). The three articles were published one month apart between March and May 2020. Their mediatization led French health authorities to intervene. Our article does not focus on and does not assess the scientific quality of the articles presented, but only aims to open the reflection on medical publication. Beyond the description of these three specific cases, this article raises issues about article retraction, peer-reviewing, preprints, authorship and the dissemination of scientific medical information, including through the mass media. It discusses new publishing modes and the dissemination of published information in clinical research.

[One day diagnosis for breast lesions: Medical and psychological assessment--EVADIASEIN study]. / Diagnostic en un jour des lésions du sein: évaluation médicale et psychologique de la prise en charge--étude EVADIASEIN.

INTRODUCTION: Breast cancer is the most frequent feminine cancer in France and its incidence increases steadily. The time of access to medical care is an indicator of the quality of the treatments recommended by the Plan Cancer 2009-2013, as it influences the diagnosis and reduces psychological morbidity during the pre-diagnosis phase. The one-day diagnosis is a recently initiated concept, which offers to get the results of the biopsy on the day it is performed and facilitates the setting-up of therapeutic care with the surgeon met during the one-day medical consultations. The aim of this study is to evaluate the satisfaction of patients who benefited from a one-day breast lesion diagnosis, as well as confirm the decrease of time of access to medical treatment. METHODS: This is an observational, non-interventional and single-centre study based on 27 patients who benefited from one-day breast lesions diagnosis over two years. The patients were only included who had a classified lesion ACR 4 or 5 and visible in the ultrasound. We analyzed the histological concordance between the biopsy and the definitive histology, the time of access to medical care, and the therapeutic treatments We analyzed the psychological impact of such an organization by sending to the patients a questionnaire including the Psychological Consequence Questionnaire (PCQ) and the Breast Cancer Anxiety Indicator (BCA) allowing to estimate the anxiety generated by the pre-diagnostic phase, the DC-Sat allowing to estimate the satisfaction of the consultation of announcement, as well as the same day diagnosis benefit. RESULTS: The patients were 59.8 years old in average [33-87]. The average time between the date of the mammography and the one-day diagnosis consultation (including the biopsy) was 15.0 days [0-60]. Fifty-seven percent of the patients considered this time as short. The average time between the biopsy date and the start of the treatment was 15.9 days [4-30]. The one-day diagnosis took an average of 1.6 days [1-5]. The results of the PCQ showed an important emotional impact during the diagnosis phase, and the average BCA score reached an average of 3.9 on a scale of 5. However, the patients were very satisfied with the diagnosis consultation with an average of 8.7 on a scale of 10, and 95% think the one-day diagnosis is beneficial to the patients. DISCUSSION: This study shows that the one-day breast-damage diagnosis enables to improve the time of access to care, and meets the current recommendations. Even though faster access to treatment does not reduce the psychological morbidity of awaiting diagnosis, the patients express their satisfaction and find the rapidity of the pre-diagnosis phase beneficial. CONCLUSION: In view of this study, the one-day breast-damage diagnosis appears to be a quality feature in the process of access to care and treatment of the patients.

The Intestinal Gas Questionnaire: development of a new instrument for measuring gas-related symptoms and their impact on daily life.

BACKGROUND: Although gas-related symptoms (GRS) are common and intrusive, there are no questionnaires to quantitate this problem. This study aimed to develop an instrument to rectify this gap in our knowledge. METHODS: Concepts were initially identified from the literature and interviews with gastroenterologists. Exploratory one-to-one interviews and focus groups with irritable bowel syndrome (IBS) patients (n = 28) and non-IBS subjects (n = 27) with GRS were conducted in UK, France, and Spain leading to a conceptual framework for the questionnaire. Last, iterative rounds of cognitive debriefing were performed with IBS (n = 16) and non-IBS subjects (n = 14). KEY RESULTS: From the first three steps, nine GRS (bloating, distension, flatulence, odorous flatulence, difficult gas evacuation, stomach rumbling, belching, bad breath, and abdominal movement) were identified although abdominal movement was subsequently excluded. Twelve quality of life domains affected by these symptoms were identified as: Clothing, emotional, physical appearance, diet, daily living, work, social life, physical activity, relationships, sex life, sleep, and cognitive function. A 24-h recall for symptoms and a 7-day recall for impact assessment were supported by the qualitative findings. Cognitive debriefing confirmed the understanding of the instrument. Across the three languages, the instrument was conceptually and linguistically consistent. CONCLUSIONS & INFERENCES: The International Gas Questionnaire is a 2-part instrument, developed rigorously and simultaneously in three languages assessing seven symptoms (17 items) and their impact on 12 domains (26 items) in IBS and general population. It is now undergoing psychometric validation and should provide a unique tool for epidemiological surveys and clinical trials for developing new treatments for these symptoms.

[How can an effective drug to treat irritable bowel syndrome be successfully developed?]. / Développer un médicament dans le syndrome de l'intestin irritable : une mission impossible ?

BACKGROUND: Irritable bowel syndrome (IBS) is a prevalent disorder, and although the pharmaceutical industry knows the potential fallout of a successful drug launch in this area, effective drug treatments are rare. AIM: To give an overview of the main factors interfering with the development of IBS drugs and to provide pertinent methodological indications to improve their investigation in clinical trials. RESULTS: Developing IBS drugs remains a major challenge, as numerous factors, related or unrelated to the nature of the disease itself, interfere with the demonstration of efficacy : the multiplicity of physiopathological mechanisms, wide variation in symptoms across patients and over time, associated psychological traits and environmental aspects, and a very significant placebo effect. There can be no question of developing drugs to target a single receptor in the hope of thereby impacting the whole range of factors involved in the genesis of IBS symptoms. Drug safety is, moreover, a prime consideration, given that this pathology, while certainly disabling, is not life-threatening. If a significant difference between a new treatment and placebo is to be demonstrated on a clinical trial, inclusion and efficacy criteria and study treatment duration must be predefined very precisely. The primary endpoint is abdominal pain, but the assessment of relief of the patient's symptoms has been also recommended, even if there is as yet no consensus as to its definition. The impact of a new IBS drug on patient's quality of life is an important secondary endpoint. CONCLUSION: In IBS more, perhaps, than in other pathologies, study design needs very careful consideration if new IBS drug trials are to be conclusive. However, some critical methodological issues (e.g., definite primary endpoint, interpretation of results, and definition of responders) are still unresolved.

Validation of a questionnaire for assessment of asthma patient knowledge and behaviour.

BACKGROUND: For several years, educational programmes have been highlighted because care success depends on patient's knowledge and patient's asthma management. However, no tool is available to assess change in patient knowledge and behaviour before and after completing an educational programme. OBJECTIVE: To validate a questionnaire measuring the knowledge and behaviour of asthmatics participating in an educational programme and to gauge the benefit of such a programme. METHODS: The Asthma Behaviour Change (ABC) questionnaire was generated from literature, patient surveys and clinical situations. It was organized in eight dimensions assessing patient behaviour in seven different clinical situations and two assessing patient (pathophysiology and therapeutic) knowledge. A total of 139 asthmatics filled out the questionnaire before, during and after the educational programme. RESULTS: The principal component analysis confirmed the structure empirically made by clinical situations. Internal consistency analysis yielded high Cronbach's alpha values. Different dimensions and the two global scores were able to discriminate patients according to asthma severity. Finally, the effect size of difference before and after educational programme was at least 0.47, and was larger than 0.74 for both global behaviour and knowledge scores. The difference between visit 1 and 3 for global behaviour and knowledge scores reached 18.84 +/- 20.83 (P < 0.001, 95% CI: 13.18-24.43) and 11.06 +/- 14.98 (P < 0.001, 95% CI: 7.10-15.03), respectively. CONCLUSION: ABC questionnaire is a valid tool to assess asthmatics' knowledge and behaviour. Furthermore, this study confirmed that educational programmes lead to better awareness of asthma by patients.

Ethics and clinical trials.

The current reference guideline about ethics in clinical trials is the Declaration of Helsinki of human rights in medical research. Three major principles are emphasised: respect of the patient to accept or not to participate in a trial, the constraints and the presumed risks must be acceptable for patients included in a study, and vulnerable subjects should not participate in studies. The investigator is responsible for obtaining a free and well-informed consent from patients before their inclusion in a study. Where possible, a new drug should always first be compared to placebo in order to prove its superiority. Else, a small-sized trial comparing a new drug versus a reference treatment can lead to an erroneous conclusion of absence of difference. Moreover, good results or improvement are obtained in at least 30% of cases with placebo, whatever the disease. The use of placebo is unethical in life-threatening diseases and when an effective proved drug exists. The use of placebo is ethical in severe diseases with no efficient drug, in some severe diseases even when an active reference treatment is available, and in all moderate and functional diseases. In order to detect flawed studies, most journals now ask for any manuscript submitted and reporting results of a randomised clinical trial to join a checklist in order to verify the quality of the trial. Finally, it remains the responsibility of the doctor to decide whether or not a protocol is ethical, to participate or not and to include patients or not.