French Committee Research Articles

L’accréditation en anatomie et cytologie pathologiques

The purpose of this article is to provide a simple explanation of the accreditation process applied to the field of pathology. After defining some basic notions in the field of quality in health, and then detailing the accreditation process in general, we focus on the specific field of pathology with the implementation of the quality management system, the validation or verification of the methods and then the audit of the structure by the French committee for accreditation COFRAC. We end with some general considerations, insisting on the benefits brought by the entry of a structure into this accreditation process.

Verification of analytical performance of the 25-OH vitamin D assay on the Abbott Alinity ci®: Experience of the central laboratory of Mohammed VI University Hospital of Oujda

The primary goal of our study was to verify the analytical performance of the 25-OH Vitamin D measurements conducted on the Abbott CI analyzer using the immuno-chemiluminescence method. This verification took place in the biochemistry laboratory at Mohammed VI University Hospital in Oujda. Our methodology was aligned with the recommendations outlined in the French accreditation committee (COFRAC) technical guide (GTA) 04, emphasizing the assessment of reproducibility and repeatability. Overall, the results of this evaluation were satisfactory and met the standards set by both the supplier and the French Society of Clinical Biology. This study illustrates that the biochemistry laboratory at Mohammed VI University Hospital of Oujda is equipped to provide accurate and precise results, which are crucial for effective clinical diagnosis and decision-making.

Verification of analytical performance of intact parathyroid hormone assay on the Abbott Alinity ci®: Experience of the central laboratory of Mohammed VI University Hospital of Oujda

The primary goal of our study was to verify the analytical performance of intact parathyroid hormone measurements conducted on the Abbott CI analyzer using the immuno-chemiluminescence method. This verification took place in the biochemistry laboratory at Mohammed VI University Hospital in Oujda. Our methodology was aligned with the recommendations outlined in the French accreditation committee (COFRAC) technical guide (GTA) 04, emphasizing the assessment of reproducibility and repeatability. Overall, the results of this evaluation were satisfactory and met the standards set by both the supplier and the French Society of Clinical Biology. This study illustrates that the biochemistry laboratory at Mohammed VI University Hospital of Oujda is equipped to provide accurate and precise results, which are crucial for effective clinical diagnosis and decision-making.

Real-world multidisciplinary outcomes of onasemnogene abeparvovec monotherapy in patients with spinal muscular atrophy type 1: experience of the French cohort in the first three years of treatment

BackgroundSpinal muscular atrophy type 1 (SMA1) is the most severe and early form of SMA, a genetic disease with motor neuron degeneration. Onasemnogene abeparvovec gene transfer therapy (GT) has changed the natural history of SMA1, but real-world data are scarce.MethodsA French national expert committee identified 95 newly diagnosed treatment-naive SMA1 patients between June 2019 and June 2022. We prospectively report on children treated with GT as the first and only therapy who had more than one-year of follow-up.ResultsForty-six SMA1 patients received GT. Twelve patients received other treatments. Patients with respiratory insufficiency were oriented toward palliative care after discussion with families. Twenty-nine of the treated patients with more than 12 months of follow-up were included in the follow-up analysis. Among them, 17 had 24 months of follow-up. The mean age at treatment was 7.5 (2.1–12.5) months. Twenty-two patients had two SMN2 copies, and seven had three copies. One infant died in the month following GT due to severe thrombotic microangiopathy, and another died due to respiratory distress. Among the 17 patients with 24 months of follow-up, 90% required spinal bracing (15/17), three patients required nocturnal noninvasive ventilation, and two needed gastrostomy. Concerning motor milestones at the 24-month follow-up, all patients held their head, 15/17 sat for 30 s unassisted, and 12/17 stood with aid. Motor scores (CHOPINTEND and HINE-2) and thoracic circumference significantly improved in all patients.ConclusionsOur study shows favorable motor outcomes and preserved respiratory and feeding functions in treatment-naive SMA1 infants treated by GT as the first and only therapy before respiratory and bulbar dysfunctions occurred. Nevertheless, almost all patients developed spinal deformities.

Enhancing precision through AI-enhanced method verification validating iron determination on the Alinity ci® Analyzer: Experience of the central laboratory of Mohammed VI University Hospital of Oujda

This study meticulously assessed the analytical performance of iron determination on the Alinity ci® analyzer, employing advanced AI-powered method verification techniques. Conducted at Mohammed VI University Hospital's central laboratory in Oujda, Morocco, the validation process strictly adhered to the rigorous guidelines outlined in the French accreditation committee's (COFRAC) Accreditation Technical Guide (GTA) 04. Through comprehensive assessments of repeatability and reproducibility, we definitively confirmed the assay's precision and reliability. Our evaluation yielded highly satisfactory results, consistently exceeding the established criteria set forth by both the instrument manufacturer and esteemed professional organizations like SFBC and RICOS. This unequivocally validates the laboratory's capability to deliver accurate and reproducible iron concentration measurements, crucial for enhanced clinical diagnostics and, ultimately, well-informed patient care decisions. This study underscores the importance of stringent validation processes in ensuring the reliability of diagnostic assays, thereby bolstering confidence in laboratory medicine practices and patient outcomes.

Verification of analytical performance of Unsaturated iron binding capacity (UIBC) assay on the Abbott Alinity ci®: Experience of the central laboratory of Mohammed VI University Hospital of Oujda

The verification of analytical methods is a requirement outlined by the International Organization for Standardization (ISO). This process involves evaluating the performance of an analytical method according to a well-defined protocol and subsequently comparing it with pre-established analytical objectives. In our study, we conducted an evaluation of the analytical performance of the unsaturated iron binding capacity assay using the Abbott kit on the Alinity CI analyzer in the biochemistry laboratory of Mohammed VI University Hospital in Oujda. The methodology employed adheres to the recommendations of the French accreditation committee (COFRAC) accreditation technical guide SH GTA 04, focusing on the assessment of reproducibility and repeatability. Overall, the results obtained from the study are considered satisfactory and align with the acceptability criteria recommended by the supplier. It's important to note that the accuracy and reliability of examination results are influenced not only by laboratory personnel, equipment, and environmental conditions, but also by the methods utilized and their eventual validation or verification.

Young urologists and kidney transplantation training: A survey designed by the French Transplantation Committee of the French Association of Urology (CTAFU) and the French Association of Urologists in training (AFUF)

ObjectiveIn France, kidney transplantations (KT) are mainly performed by urologist. Young urologists and residents are involved in this activity mostly performed in emergency. How do they feel about KT training? Is KT an attractive part of the urologist activity? MethodsThis survey has been designed in the form of a questionnaire by the French Committee of Kidney Transplantation (CTAFU) and the French Association of Urologists in training (AFUF). It has been sent by e-mail to all the AFUF members. Interest in KT and performance of the training were evaluated. ResultsIn total, 126 members filed the form. Among the residents, 51.5% feel secure to perform KT at the end of their residency. KT is considered as an interesting surgery for 92.1% of the participants: 76.5% are willing to get involved in KT during their residency/fellowship. Among the participants, 44% are willing to continue a long-term involvement. Among the residents, 65.9% consider their practical training insufficient: 56.8% have been supervised for a KT performance during their residency and 86% declare a lack of practical training and had a patient-based learning. Among the residents, 92.1% declare an insufficient theorical training. Among the residents, 33.3% say the schedules of transplantation limit their interest in KT. Among the participants, 34.4% receive a transplant bonus in addition to the usual on-call salary. ConclusionYoung urologists wish to continue their involvement in KT activity, but improved theoretical and practical training are essential. In addition, the conditions under which this activity is performed and remunerated are a matter of concern. Level of evidence3

A French nationwide survey of phototherapy in very preterm and moderately preterm infants

Phototherapy for jaundice in preterm infants should always be administered in accordance with specific guidelines. However, guidelines on phototherapy in very preterm and moderately preterm infants are currently lacking in France. We performed a nationwide quality improvement study of the management of jaundice in these preterm infants and compared the results with the international guidelines. Of the 275 maternity units initially contacted, 165 (60.0%) replied. Our results showed that clinical practice differs markedly from one unit to another – notably with regard to the prescription, administration, and monitoring of phototherapy and the reference curves used. Even though there is limited evidence on the safety and efficacy of phototherapy in very or moderately preterm infants, a French expert committee should be encouraged to develop consensus guidelines and thus improve quality of care in this setting.

Breast cancer: a randomized controlled trial assessing the effect of a decision aid on mammography screening uptake: study protocol.

Breast cancer (BC) is the primary cancer among women. The World Health Organization recommends a bilateral screening mammogram every 2 years for women aged 50 to 74 years. However, it has been shown that there is an absence of information about the benefits and risks of screening. Shared medical decision-making is important to ensure patients are involved in the decision process. Decision aids can facilitative this decision-making process. This article presents a protocol to evaluate the effect of a decision aid on participation rates in the French organized BC screening program. Design and setting. The design is a 2 arm randomized controlled study, performed in the Pays de la Loire region (French West Coast). Randomization will be based on general medicine practices (Primary Care). Women aged between 50 and 74 years, eligible for BC screening. In this region, there are 75000 women, and 2800 general practitioners eligible for recruitment. In the « Decision aid for organized cancer screening » arm, the intervention will distribute invitation letters to eligible women combined with the provision of decision aid to these women and their general practitioners and an incentive to implement shared medical decision-making. In the « Standard organized cancer screening » arm, only the screening invitation will be sent to eligible women. BC screening participation rates will be assessed after an 18-month follow-up period. In this non-inferiority trial, the percentage of women who are up-to-date with their screening at 18 months after the intervention will be compared across arms using a generalized mixed linear model. The research team expect to demonstrate that providing a better explanation of the benefits and risks of BC screening is not at odds with screening participation. The study results should help policy makers thinking about implementing shared medical decision-making within the framework of organized BC screening programs in the future. On 6 December 2021, the protocol received a favorable opinion from the French Committee for the Protection of Persons (2021-A01583-38). This study is registered with ClinicalTrials.gov, number NCT05607849. (Version 1, November 7, 2022; https://www.clinicaltrials.gov/ct2/show/NCT05607849). The study findings will be used for publication in peer-reviewed scientific journals and presentations in scientific meetings.

Study protocol of the CREDO randomised controlled trial: evaluation of a structured return home consultation for patients suffering from metastaticcancer

IntroductionPatients suffering from cancer are often managed by multiple health professionals. General practitioners with specific skills in oncology could facilitate care coordination between hospital and general practice in the management...

Androgen deprivation therapy prescription, blood and bone-density testing in a French population-based study exploring adherence to the French prostate cancer guidelines

The safety profile of androgen deprivation therapy (ADT) is well known, and cardiovascular and osteoporosis risk factors should be assessed before ADT initiation. In order to examine whether the French Committee of Urologic Oncology Prostate Cancer (PCa) Guidelines were properly followed by clinicians, including urologists, oncologists and radiotherapists, we used a nationwide comprehensive cohort of prostate cancer patients, who were new ADT users in 2011 and were followed-up to 2013. Reimbursements for biological examinations and prescribers were identified, as well as PCa specialist consultations at drug initiation. Our results in this French cohort showed that the proportions of patients resorting to specialized care between one year and 3 months before ADT initiation and in the 6 months following was around 40% for fasting glucose and 30% for lipid assessments. Bone densitometry was performed in approximately 1% of patients. In the 12 months after ADT initiation, 75% of the patients were seen by a urologist and about 47% by an oncologist or a radiotherapist. Overall, there is still room for improvement in terms of ADT monitoring by clinicians and in the information provided to general practitioners and patients regarding the expected adverse effects of this treatment.

Internationalized science and human rights activism during the late Cold War: The French Committee of Mathematicians.

This article examines the ties between an internationalised science and transnational activism, in particular for causes considered universal, such as defending human rights, during the late Cold War. It focuses on a scientific network that supported mathematicians persecuted for their political views by both left- and right-wing undemocratic regimes. The Committee of Mathematicians was founded in 1974 and was active for a decade, built incrementally as a transnational advocacy network located in several Western countries. Focussing primarily on the Committee's French component, this article investigates the social and organisational underpinnings of its transnational action and defence of universal principles. It examines the modes of action and how they were shaped by scientists' professional and even disciplinary affiliations. These focal points allow an interrogation of the place the committee occupied within the space of human rights activism. The article aims to contribute to a historical sociology of the ties between science and politics and of the transnational trends that strained national frameworks, while moving away from an approach focussed solely on political macrotrends that fuelled the Cold War.

P0022 - 5-year continuation rate of intra-vesical BoNTA injections in multiple sclerosis patients with lower urinary tract dysfunction: A retrospective study from the French Committee of Neuro-Urology

P0022 - 5-year continuation rate of intra-vesical BoNTA injections in multiple sclerosis patients with lower urinary tract dysfunction: A retrospective study from the French Committee of Neuro-Urology

L'Espagne Républicaine: French Policy and Spanish Republicanism in Liberated France

L'Espagne Républicaine: French Policy and Spanish Republicanism in Liberated France

Early Identification of Severe COVID-19 in Hospitalised Patients: A Large, French Multicentre Case Series

Background: Early identification of patients at risk for severe coronavirus disease 2019 (COVID-19) is a major issue to help clinicians optimise patient-flow management and allocation of healthcare resources. Methods: This retrospective, observational, multicentre study included all consecutive patients admitted to hospital with COVID-19 across 24 centres in France between February 26 and April 20, 2020. Comprehensive data, including clinical, biological, and imaging variables, were recorded at admission. The primary outcome was a composite of transfer to intensive care unit (ICU) or in-hospital death without transfer to ICU. Findings: Among 2878 patients (57·9% men, 67±17 years), the primary outcome occurred in 838 (29·3%) patients: 19·1% were transferred to ICU and 10·0% died in-hospital without transfer to ICU. Based on the derivation cohort (n=2105), 12 variables were independently associated with the primary outcome in the final model: demographics (age, sex), triage vitals (body temperature, Glasgow coma scale, dyspnoea, respiratory frequency, fraction of inspired oxygen), biological (platelets, C-reactive protein, aspartate aminotransferase, glomerular filtration rate), and imaging (degree of scanographic lesions) data. A risk-stratification score was developed that displayed accurate calibration and discrimination, with C-statistics of 0·80 (95% confidence interval 0·78 to 0·82) in the derivation cohort and 0·79 (95% confidence interval 0·75 to 0·83) in validation cohort. Interpretation: Using data from a multicentre series of patients with COVID-19, we identified independent predictors of severe COVID-19 in hospitalised patients, including clinical, biological, and imaging variables at admission. An accurate integrative risk score was developed and externally validated to optimise early triage of patients. Trial Registration: NCT04344327 Funding Statement: None. Declaration of Interests: None. Ethics Approval Statement: The CCF study was declared to and authorised by the French data protection committee (Commission Nationale Informatique et Liberte, CNIL, authorisation n°2207326v0), and was conducted in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments.

A simple and fast LC-MS/MS method for the routine measurement of cabozantinib, olaparib, palbociclib, pazopanib, sorafenib, sunitinib and its main active metabolite in human plasma

Targeted therapies such as cabozantinib (CABO), pazopanib (PAZO), sorafenib (SORA), sunitinib (SUNI) and its main active metabolite N-desethyl-sunitinib (DST-SUNI), olaparib (OLA) and palbociclib (PALBO) display large pharmacokinetics variability impacting their responses in terms of efficacy or toxicity. For the monitoring of these drugs, an analytical method allowing to routinely measure their concentrations in human plasma is needed. Such a method has been developed and validated and is presented here.The chromatographic separation is achieved on a Zorbax Bonus-RP analytical column using an isocratic elution of 92% V/V of acetonitrile and 8% of water in 0.1% formic acid at a flow rate of 500 µl/min for 0.5 min and then 300 µl/min for 2 min. After a liquid-liquid extraction of plasma samples, a step of filtration is performed. This method was validated based on the EMA and French committee of accreditation guidelines.The analysis time is 2.5 min per run, and all analytes eluted within 0.53–1.61 min. The standard curves are linear over the range from 1 to 380 ng/ml for SUNI; from 4.3 to 450 ng/ml for DST-SUNI; from 6 to 1000 ng/ml for PALBO; from 75 to 5000 ng/ml for CABO, from 0.17 to 20 µg/ml for OLA; from 0.35 to 40 µg/ml for SORA and from 1.7 to 200 µg/ml for PAZO. The method also showed satisfactory results in terms precision (below 9.5% for within-run and below 13% for between-run) and accuracy (below 13.5% for within-run and below 14% for between-run). After sampling, all the compounds are stable in whole blood at ambient temperature at least for 6 h and plasma are stable for 48 h at ambient temperature or 4 °C.The method presented here allows to measure the concentrations of 7 targeted therapies in a routine setting. We moreover present here a method that is, to our knowledge, one of the first detailed method aimed at the measurement of palbociclib in human plasma in a routine setting, together with data useful for the management of samples in routine hospital practice.

LUCSO-1—French pilot study of LUng Cancer Screening with low-dose computed tomography in a smokers population exposed to Occupational lung carcinogens: study protocol

IntroductionGuidelines concerning the follow-up of subjects occupationally exposed to lung carcinogens, published in France in 2015, recommended the setting up of a trial of low-dose chest CT lung cancer screening...

Compulsive eating behaviors in Parkinson's disease.

Eating disorders are common in Parkinson's disease (PD) patients and often class in Impulse control disorders, however, little is known about their phenomenology. Specific symptoms and comorbidities were described in a group of PD patients in this preliminary study. Over a period of 6 months, 51 PD patients who experienced significant changes in eating habits following diagnosis of PD and were interviewed during regularly scheduled follow-up visits. We assessed each patient's height and weight, impulsivity, psychological distress, current eating disorder symptoms, food addiction, food habits and craving. Among the PD patients who experienced modified dietary habits following diagnosis, few exhibited binge eating disorders (BED) full criteria (3.9%). However, 21.6% of patients experienced episodes of out-of-control eating with a large quantity of food in short time and 39.2% satisfied food addiction (FA) criteria without binge eating disorder. Food cravings more than once a week were experienced in approximately half of the population including all FA patients. Regarding comorbidities, FA PD patients present impulsive features and anxiety. This study confirms the existence of FA profile in PD patients. Eating disorders even in PD are complex and have a cross-cutting criteria related to out-of-control eating, FA, and BED. The association of anxiety with PD-related food addiction, contrary to L-dopa equivalent daily dose mean score or the presence of dopamine agonists, underline the complex sustainability of the dopaminergic brainstem support. A study on their detailed prevalence in this population could be helpful to better understand unspecified feeding or eating disorder. DR-2012-007. French Committee for the Protection of Persons (CPP) & French National Commission on Computing and Liberty (CNIL). Level V, descriptive study.

Cost-effectiveness of pirfenidone compared to all available strategies for the treatment of idiopathic pulmonary fibrosis in France

ABSTRACTObjective: To update the health economic evaluation of pirfenidone in the treatment of idiopathic pulmonary fibrosis (IPF) compared to all available alternatives strategies (Best supportive care – BSC and nintedanib), based on a cost-utility model previously validated by the CEESP’s (French Committee for Economic Evaluation) in 2014.Methods: A standard Markov cohort model, adapted to French methodology guidelines, was used to simulate the therapeutic management and the course of IPF patients (including potential adverse events) using the collective perspective. Cost-effectiveness was evaluated regarding life years (LY); quality-adjusted life-years (QALY); average cumulative costs; the incremental cost-effectiveness ratio (ICER) expressed in cost per QALY gained. Data were retrieved from trials, meta-analysis, literature, health insurance and hospitalisation databases, and national tariffs.Results: Over 15 years, total costs accumulated in the pirfenidone strategy were estimated at €99,477 per patient, €104,610 in nintedanib, and €14,177 in Best Supportive Care (BSC). The total number of QALYs accumulated equalled 5.20 (6.91 LYs), 4.52 (5.98 LYs), and 3.79 (4.98 LYs), respectively. Pirfenidone was estimated to be dominant over nintedanib with incremental costs of -€5,133 and 0.67 more QALYs accumulated. Incremental cost versus BSC was €85,300 and 1,404 QALY gained. The cost-effectiveness ratio was estimated at 60,738€/QALY when compared to BSC.Conclusion: Pirfenidone is likely to be a cost–effective strategy compared to BSC and seems more efficient and less costly compared to nintedanib for the treatment of patients with IPF in France.

Reliability of ultrasound measurements of quadriceps muscle thickness in critically ill patients

BackgroundMuscle wasting in critically ill patients is associated with negative clinical outcomes. Ultrasound quadriceps femoris muscle assessment may constitute a convenient tool to evaluate muscle wasting. Nevertheless, its reliability remains uncertain. Our primary aim was to study the intra- and inter-observer reliability of this technique. Our secondary aim was to assess the evolution of the quadriceps muscle during the first 3 weeks after ICU admission and its possible association with nutritional intake.MethodsThis observational study included patients expected to stay more than 7 days in the ICU. Ultrasound quadriceps muscle thickness was measured with a 12 MHz linear transducer, by two trained physicians, on D1, D3, D5, D7 and D21. Two measurements sites were evaluated: on the midpoint or on the two-thirds of the length between the anterior superior iliac spine and the upper border of the patella. Intra and inter-observer reliability was assessed by calculating the intra-class correlation coefficient (ICC).ResultsA total of 280 ultrasound quadriceps thickness measurements were performed on 29 critically ill patients. Intra-observer reliability’s ICC was 0.74 [95% CI 0.63; 0.84] at the “midpoint” site and 0.83 [95% CI 0.75; 0.9] at the “two-thirds” site. Inter-observer reliability’s ICC was 0.76 [95% CI, 0.66; 0.86] at the “midpoint” site and 0.81 [95% CI, 0.7; 0.9] at the “two-thirds” site. Quadriceps femoris muscle thickness decreased over 16% within the first week after ICU admission. No correlation was found between muscle loss and caloric (p = 0.96) or protein (p = 0.80) debt over the first week.ConclusionThe assessment by ultrasonography of the quadriceps muscle thickness reveals good intra- and inter-observer reliability and may constitute a promising tool to evaluate the effect of nutritional-based interventions on muscle wasting in critically ill patients.Trial registration“Committee for the Protection of Human Subjects in Biomedical Research” - Paris Ile de France VI Pitié-Salpêtrière – 10/07/2014.French Data Protection Committee (“Commission Nationale Informatique et Libertés”) - #1771144.