Published registered reports are rare, limited to one journal group, and inadequate for randomized controlled trials in the clinical field.

OBJECTIVE: Registered reports (RR) are a publication format implying a peer-review of the protocol before the start of the study, followed by an in-principle acceptance (IPA) by the journal before the study starts. We aimed to describe randomized controlled trials (RCTs) in the clinical field published as RR. STUDY DESIGN AND SETTING: This cross-sectional study included RR results for RCTs, identified on PubMed/Medline and on a list compiled by the Center for Open Science. It explored the proportion of reports that received IPA (and/or published a protocol before inclusion of the first patient) and changes in the primary outcome. RESULTS: A total of 93 RCTs publications identified as RR were included. All but one were published in the same journal group. The date of the IPA was never documented. For most of these reports (79/93, 84.9%), a protocol was published after the date of inclusion of the first patient. A change in the primary outcome was noted in 40/93 (44%) of them. Thirteen of the 40 (33%) mentioned this change. CONCLUSIONS: RCTs in the clinical field identified as RR were rare, originated from a single journal group, and did not comply with the basic features of this format.

Patients Participating in Nasogastric Tube Insertion through Hypnoanalgesia during High-dose Chemotherapy-induced Aplasia.

The insertion of a nasogastric (NG) tube is often a difficult experience for both patients and caregivers. This often results in a high failure rate of NG insertion. This pilot study aimed to evaluate the effectiveness, tolerance, and acceptability of hypnoanalgesia to assist self-insertion of an NG tube. Patients undergoing high-dose chemotherapy for autologous or allogeneic hematopoietic stem cell transplantation (HSCT) or acute leukemia and with high risk of aplasia were included in the study. A total of 38 patients were included during 6 consecutive months. They all achieved successful NG tube self-insertion. The NG tube remained in place during hospitalization in 32 cases for an average duration of 15 days. Six patients rejected the NG tube during vomiting but they all voluntarily attempted it again later on and succeeded. The discomfort related to NG-tube insertion was mild. This pilot study suggests that NG tube self-insertion assisted by hypnoanalgesia may be effective, well-accepted, and well-tolerated in patients. These promising findings will need further confirmation.

Syphilis is a Rare Cause of Erythema Nodosum: A Case Report.

Erythema nodosum (EN) is a dermatological manifestation, the common etiologies of which are already widely described. Here, we report the case of a patient who presented an EN, where the etiology was found to be a rare diagnosis: syphilis, a sexually transmitted infection with various clinical presentations. A 42-year-old female patient without any medical condition presented with a clinical picture associating a maculopapular rash at first, and later on a well-defined hypodermic lesion, clinically suggestive of an EN, on the right forearm. The etiologic workup ruled out sarcoidosis, which was the first suspected diagnosis. Positive VDRL-TPHA and recovery within 15 days after benzathine benzylpenicillin administration allowed the diagnosis of syphilis to be made on the EN. EN is a rare manifestation of syphilis that should be kept in mind in these times of strong recrudescence of the disease among men who have sex with men in mainland France but also among heterosexuals in Reunion Island.

Evaluation of remote assessment reliability in the follow-up of patients with diabetic macular edema.

PURPOSE: To compare the reliability of office versus remote assessments in the decision to use intravitreal injection for patients with diabetic macular edema (DME). METHOD: We retrospectively evaluated office and remote assessments for decision agreement regarding treatment by intravitreal injection or non-treatment for DME. Remote assessment consisted in remote evaluation of patient medical data by three reviewers with different skills. Two OCT analysis strategies were performed with the same office assessment data: 1) macular mapping with only two OCT B-scans passing through the fovea, and 2) macular mapping with complete macular scans. Agreement for treatment decisions and OCT analysis strategies were analysed using Cohen's Kappa coefficient (κ). RESULTS: Data from 49 patients (96 eyes) were included. Treatment decision agreement with two OCT B-scans passing through the fovea was considered excellent for all reviewers (κ between 0.80 and 0.85, varying between reviewers). Treatment decision agreement with complete macular scans was considered excellent (κ between 0.85 and 0.93, varying between reviewers). Agreement between the two OCT analysis strategies and reviewers was considered excellent. CONCLUSION: Remote assessment in a telemedicine model can be a useful alternative for DME patient follow-up.

Diabetes incidence in subjects with PREDIABetes from ReUNion Island: the PREDIABRUN observational cohort study protocol.

INTRODUCTION: Improved knowledge of prediabetic subjects' profile and their risk of developing type 2 diabetes mellitus (T2DM) would enhance secondary prevention. The primary objective is to describe factors associated with incident T2DM in subjects with pre-diabetes diagnosed in primary care. METHODS AND ANALYSIS: The study is based on Reunion Island, a French overseas region that experiences a particularly high disease burden of T2DM. This is an observational, non-randomised prospective cohort study conducted in primary care in which private general practitioner (GP) investigators recruit participants with pre-diabetes from their practices regardless of the initial motive for consultation. Pre-diabetes is defined by WHO criteria, that is, fasting plasma glucose between 1.10 g/L and 1.25 g/L and/or plasma glucose 2 hours after ingestion of 75 g of glucose (2-hour post load plasma glucose) between 1.40 g/L and 1.99 g/L. The design is based on an annual follow-up by the GP (according to French National Health Authority recommendations) with collection of clinical and laboratory data and specific lifestyle questionnaires answered by telephone at three time points: inclusion, and at 2-year and 5-year follow-up visits. Follow-up clinical and laboratory data are collected by the investigating GP as part of the study, and study-specific laboratory collections (serum, DNA and urine) will be obtained 2 and 5 years after inclusion. The primary outcome is transition to T2DM. ETHICS AND DISSEMINATION: This protocol has been approved by the research ethics committee of Saint Etienne (CPP Saint Etienne reference number: 2019-03). Enrolment began in August 2019. Results will be disseminated in at least three papers published in peer-reviewed medical journals, one oral communication and a large-scale communication to the local population and healthcare policymakers. TRIAL REGISTRATION NUMBER: NCT04463160 and ID-RCB 2018-A03106-49.

Gender inequality among medical, pharmaceutical and dental practitioners in French hospitals: Where have we been and where are we now?

INTRODUCTION: Women are under-represented in senior academic and hospital positions in many countries. The authors aim to assess the place and the evolution of all appointed female and male health practitioners' working in French public Hospitals. MATERIALS AND METHODS: Data of this observational study were collected from the National Management Centre (Centre National de Gestion) from 2015 up to January 1, 2020. First, the authors described demographic characteristics and specialties of all appointed medicine, pharmacy, and dentistry doctors' working as Hospital Practitioners, Associate Professors, and Full Professors in French General and University-affiliated Hospitals in 2020. Then, they retrospectively reported the annual incidence of new entrance according to gender and professional status from 1999 to 2019 thanks to the appointment date of all practitioners in activity between 2015 and 2020. RESULTS: In 2020, 51 401 appointed practitioners (49.7% of female) were in activity in French public hospitals with a large majority being medical doctors (92.4%) compared to pharmacists (6%) and dentists (1.6%). Women represented 52.5% of the Hospital Practitioners, 48.6% of the Associate Professors, and 22.0% of the Full Professors (p < 0.001). There were disparities between the rates of female Full Professors in medicine (20.6%), pharmacy (36.1%), and dentistry (44.3%, p < 0.001). Women were appointed Hospital Practitioners and Associate Professors earlier than men (respectively 37.1 versus 38.8 years, p < 0.001 and 36.1 versus 36.5 years, p = 0.04), and at a later age among Full Professors (43.7 versus 41.9 years, p < 0.001). Compared to men, the annual proportion of appointed women varied significantly between 1999 and 2019 from 47.6% to 60.4% for Hospital Practitioners, from 50.0% to 44.6% for Associate Professors, and from 11.2% to 33.3% for Full Professors (p < 0.001 for trend). CONCLUSIONS: Although more and more women occupy positions in French hospitals, there is still a gender gap regarding access to Full Professor status in medicine and pharmacy, but not in dentistry. The disparity in numbers makes comparison difficult. Despite a trend towards gender equality during the last twenty years, it has not yet been achieved regarding access to the highest positions.

Drug-induced vitiligo: a case/non-case study in Vigibase® , the WHO pharmacovigilance database.

Vitiligo is a common depigmenting disorder ensuing the loss of epidermal melanocytes. It is a multifactorial disease with immunological, genetic and environmental factors including drug exposure. The purpose of the study was to investigate the drugs and therapeutic subclasses associated with vitiligo occurrence reported in VigiBase® , the WHO pharmacovigilance database. A case/non-case study was carried out by defining cases as vitiligo reports and non-cases as all other reports. The reporting odds ratio (ROR) was calculated for the 'suspected' drugs and drug classes according to ATC level 4. During the study period, 741 cases of vitiligo were registered. Mean age was 49 ± 20 years. The disproportionality analysis showed an association between vitiligo and pembrolizumab (ROR 116.9, 95% Confidence Interval (CI) 94.8, 144.3), nivolumab (ROR 22.6, 95% CI 15.8, 32.4), ipilimumab (ROR 41.7, 95% CI 25.0, 69.7), imiquimod (ROR 152.8, 95% CI 103.0, 226.7), adalimumab (ROR 3.8, 95% CI 2.5,5.8), infliximab (ROR 2.6, 95% CI 1.65, 4.01), alemtuzumab (ROR 27.8, 95% CI 17.6, 43.9), and ustekinumab (ROR 9.3, 95% CI 5.6, 15.6). Concerning the pharmacological classes ATC level 4, a significant association was found with monoclonal antibodies, interferons, selective immunosuppressants, TNF-alpha inhibitors, interleukin inhibitors, and topical antivirals. This study confirmed the expected associations between vitiligo and immune checkpoint inhibitors and strengthened the emerging signal about the association between vitiligo and imiquimod, TNF-alpha inhibitors and interferons. New signals were shown with selective immunosuppressants including alemtuzumab and interleukin inhibitors.