Organisation and management of clinical research in French intensive care units : a focus on clinical research professions

La recherche clinique une des pierres angulaires de la médecine et de l'activité des hôpitaux a pour but l'évaluation de nouvelles pratiques et de nouveaux traitements. Elle doit répondre à des exigences éthiques et réglementaires précises accompagnées de bonnes pratiques.Pour répondre à ces exigences, elle s'est professionnalisée au fil des années. Toutefois, peu d'études sur son organisation et ses métiers ont été réalisées. L'objectif de nos travaux était d'étudier l'organisation de la recherche clinique afin d'identifier d'éventuelles disparités des pratiques et proposer des axes d'amélioration.Bien que l'ensemble des services d'un hôpital accueillent des activités de recherche clinique, nos travaux se sont focalisés sur les unités de soins critiques, services prenant en charge les patients aux affections les plus graves et susceptibles de participer à de nombreuses thématiques de recherche.La première partie de nos travaux a consisté à la réalisation d'une revue exploratoire de la littérature afin de faire un état des lieux des recherches menées sur l'organisation des métiers de la recherche clinique. Le faible nombre des études recensées et l'hétérogénéité des organisations entre les pays voire au sein d'un même pays, ont montré l'insuffisance des connaissances disponibles sur le sujet. La seconde partie de nos travaux a permis - par une enquête en ligne auprès de professionnels impliqués dans la recherche clinique - de faire un état des lieux des métiers de la recherche clinique dans les unités de soins critiques en France. En plus d'avoir confirmé l'hétérogénéité des profils du personnel, notamment en matière de la formation initiale, nous avons montré que la polyvalence et l'autonomie étaient perçues comme l'aspect le plus apprécié des personnels, alors que le manque de temps ou de reconnaissance étaient perçus négativement.L'ensemble de ces résultats nous donnent la possibilité de continuer à enrichir ce sujet avec des perspectives d'étendre notre recherche au plan international et de proposer des pistes de réformes de structurations des formations du personnel de recherche clinique.Clinical research is one of the cornerstones of medicine and hospital activity. Its main aim is to evaluate new practices and treatments, and it must meet precise ethical and regulatory requirements, as well as good practice.To meet these requirements, it has become professional over the years. However, few studies have been carried out on the organisation of clinical research and the professions involved. The aim of our work was to study the organisation of clinical research in order to identify any disparities in practice and suggest areas for improvement.Although clinical research activities are carried out in all hospital departments, our work has focused on Intensive care units, where patients with the most serious conditions are treated, and which are likely to be involved in a wide range of research themes.The first part of our work consisted of a scoping review of the literature in order to take stock of the research carried out on the organisation of clinical research professions. The small number of studies identified and the heterogeneity of organisations between countries, and even within the same country, demonstrated the inadequacy of the knowledge available on the subject. The second part of our work - an online survey of professionals involved in clinical research - enabled us to take stock of the clinical research professions in Intensive care units in France. As well as confirming the heterogeneity of staff profiles, particularly in terms of initial training, we showed that multivalence and autonomy were perceived as the aspects most appreciated by the professional, whereas lack of time or recognition were perceived negatively.Taken together, these results give us the opportunity to continue enriching this subject, with the prospect of extending our research internationally and proposing ways of reforming the structure of training for clinical research professional

Organisation et gestion de la recherche clinique dans les réanimations françaises : regard sur les métiers de la recherche clinique

Clinical research is one of the cornerstones of medicine and hospital activity. Its main aim is to evaluate new practices and treatments, and it must meet precise ethical and regulatory requirements, as well as good practice.To meet these requirements, it has become professional over the years. However, few studies have been carried out on the organisation of clinical research and the professions involved. The aim of our work was to study the organisation of clinical research in order to identify any disparities in practice and suggest areas for improvement.Although clinical research activities are carried out in all hospital departments, our work has focused on Intensive care units, where patients with the most serious conditions are treated, and which are likely to be involved in a wide range of research themes.The first part of our work consisted of a scoping review of the literature in order to take stock of the research carried out on the organisation of clinical research professions. The small number of studies identified and the heterogeneity of organisations between countries, and even within the same country, demonstrated the inadequacy of the knowledge available on the subject. The second part of our work - an online survey of professionals involved in clinical research - enabled us to take stock of the clinical research professions in Intensive care units in France. As well as confirming the heterogeneity of staff profiles, particularly in terms of initial training, we showed that multivalence and autonomy were perceived as the aspects most appreciated by the professional, whereas lack of time or recognition were perceived negatively.Taken together, these results give us the opportunity to continue enriching this subject, with the prospect of extending our research internationally and proposing ways of reforming the structure of training for clinical research professional.La recherche clinique une des pierres angulaires de la médecine et de l'activité des hôpitaux a pour but l'évaluation de nouvelles pratiques et de nouveaux traitements. Elle doit répondre à des exigences éthiques et réglementaires précises accompagnées de bonnes pratiques.Pour répondre à ces exigences, elle s'est professionnalisée au fil des années. Toutefois, peu d'études sur son organisation et ses métiers ont été réalisées. L'objectif de nos travaux était d'étudier l'organisation de la recherche clinique afin d'identifier d'éventuelles disparités des pratiques et proposer des axes d'amélioration.Bien que l'ensemble des services d'un hôpital accueillent des activités de recherche clinique, nos travaux se sont focalisés sur les unités de soins critiques, services prenant en charge les patients aux affections les plus graves et susceptibles de participer à de nombreuses thématiques de recherche.La première partie de nos travaux a consisté à la réalisation d'une revue exploratoire de la littérature afin de faire un état des lieux des recherches menées sur l'organisation des métiers de la recherche clinique. Le faible nombre des études recensées et l'hétérogénéité des organisations entre les pays voire au sein d'un même pays, ont montré l'insuffisance des connaissances disponibles sur le sujet. La seconde partie de nos travaux a permis - par une enquête en ligne auprès de professionnels impliqués dans la recherche clinique - de faire un état des lieux des métiers de la recherche clinique dans les unités de soins critiques en France. En plus d'avoir confirmé l'hétérogénéité des profils du personnel, notamment en matière de la formation initiale, nous avons montré que la polyvalence et l'autonomie étaient perçues comme l'aspect le plus apprécié des personnels, alors que le manque de temps ou de reconnaissance étaient perçus négativement.L'ensemble de ces résultats nous donnent la possibilité de continuer à enrichir ce sujet avec des perspectives d'étendre notre recherche au plan international et de proposer des pistes de réformes de structurations des formations du personnel de recherche clinique

Organisation et gestion de la recherche clinique dans les réanimations françaises : regard sur les métiers de la recherche clinique

Clinical research is one of the cornerstones of medicine and hospital activity. Its main aim is to evaluate new practices and treatments, and it must meet precise ethical and regulatory requirements, as well as good practice.To meet these requirements, it has become professional over the years. However, few studies have been carried out on the organisation of clinical research and the professions involved. The aim of our work was to study the organisation of clinical research in order to identify any disparities in practice and suggest areas for improvement.Although clinical research activities are carried out in all hospital departments, our work has focused on Intensive care units, where patients with the most serious conditions are treated, and which are likely to be involved in a wide range of research themes.The first part of our work consisted of a scoping review of the literature in order to take stock of the research carried out on the organisation of clinical research professions. The small number of studies identified and the heterogeneity of organisations between countries, and even within the same country, demonstrated the inadequacy of the knowledge available on the subject. The second part of our work - an online survey of professionals involved in clinical research - enabled us to take stock of the clinical research professions in Intensive care units in France. As well as confirming the heterogeneity of staff profiles, particularly in terms of initial training, we showed that multivalence and autonomy were perceived as the aspects most appreciated by the professional, whereas lack of time or recognition were perceived negatively.Taken together, these results give us the opportunity to continue enriching this subject, with the prospect of extending our research internationally and proposing ways of reforming the structure of training for clinical research professional.La recherche clinique une des pierres angulaires de la médecine et de l'activité des hôpitaux a pour but l'évaluation de nouvelles pratiques et de nouveaux traitements. Elle doit répondre à des exigences éthiques et réglementaires précises accompagnées de bonnes pratiques.Pour répondre à ces exigences, elle s'est professionnalisée au fil des années. Toutefois, peu d'études sur son organisation et ses métiers ont été réalisées. L'objectif de nos travaux était d'étudier l'organisation de la recherche clinique afin d'identifier d'éventuelles disparités des pratiques et proposer des axes d'amélioration.Bien que l'ensemble des services d'un hôpital accueillent des activités de recherche clinique, nos travaux se sont focalisés sur les unités de soins critiques, services prenant en charge les patients aux affections les plus graves et susceptibles de participer à de nombreuses thématiques de recherche.La première partie de nos travaux a consisté à la réalisation d'une revue exploratoire de la littérature afin de faire un état des lieux des recherches menées sur l'organisation des métiers de la recherche clinique. Le faible nombre des études recensées et l'hétérogénéité des organisations entre les pays voire au sein d'un même pays, ont montré l'insuffisance des connaissances disponibles sur le sujet. La seconde partie de nos travaux a permis - par une enquête en ligne auprès de professionnels impliqués dans la recherche clinique - de faire un état des lieux des métiers de la recherche clinique dans les unités de soins critiques en France. En plus d'avoir confirmé l'hétérogénéité des profils du personnel, notamment en matière de la formation initiale, nous avons montré que la polyvalence et l'autonomie étaient perçues comme l'aspect le plus apprécié des personnels, alors que le manque de temps ou de reconnaissance étaient perçus négativement.L'ensemble de ces résultats nous donnent la possibilité de continuer à enrichir ce sujet avec des perspectives d'étendre notre recherche au plan international et de proposer des pistes de réformes de structurations des formations du personnel de recherche clinique

Organisation of clinical research in intensive care units: A scoping review

International audienceBackground: Clinical research is essential for the development and progress of therapies and procedures. Intensive care units (ICUs) manage the sickest patients. Numerous clinical trials are organised in ICUs to evaluate new treatments or support techniques. Concomitantly, new professions involved in clinical research set-ups are emerging.Aim: The aim of this scoping review was to identify the nature and extent of research evidence on the organisation of clinical research in ICUs.Methods: This review focusses on observational and qualitative narrative studies dealing with clinical research organisation in ICUs, with a special interest in structures coordinating research, the roles of clinical research professionals, and the training required. Medline and Embase were analysed between January 2000 and June 2024. Assessment of the study quality was based on the Let Evidence Guide Every New Decision evaluation system and the Newcastle-Ottawa quality assessment scale.Results: Of the 14 studies reviewed, four were narrative and 10 observational descriptive. All were based on cross-sectional surveys. Most studies were carried out in North America, the United Kingdom, and Australia/New Zealand. ICU clinical research professionals were mostly female nurses aged between 31 and 50 years who had a wide diversity of training profiles and performed greatly varied tasks from data collection to publication of the article. Reported job satisfaction depended on the degree of autonomy, the workload, the extent of professional recognition, and opportunities for professional promotion.Conclusions: The organisation of ICU clinical research reflects considerable diversity in training, tasks, job organisation, and responsibilities

Job description and perception of clinical research personnel working in a network of French intensive care units

International audienceThere is a lack of information about the organisation and management of clinical research personnel in Europe and of their professional activity in intensive care. We therefore conducted a cross-sectional survey among personnel currently working in a French intensive care research network that involves 41 centres nationwide. The aim of the survey was to describe the personnel's personal and institutional organisation and management, their job perception in terms of satisfaction and stress, and suggestions for improvement.Methods Over 3 months in 2023, the research personnel received an electronic questionnaire on their personal and professional profile, past and present training, workplace and functions currently performed, personal knowledge about job skills required, job satisfaction and stress by as measured on a rating scale, and suggested ways of improvement. ResultsNinety seven people replied to the questionnaire (a response rate of 71.3%), of whom 78 (57.3%) were sufficiently involved in intensive care to provide complete answers. This core sample had profiles in line with French recruitment policies and comprised mainly Bachelor/Master graduates, with nurses accounting for only 21.8%. The female to male ratio was 77:23%. Many responders declared to have a shared activity of technician (for investigation) and assistant (for quality control). More than 70% of the responders considered that most of the tasks required of each worker were major. Figures were much lower for project managers, who were few to take part in the survey. On a scale of 10, the median of job satisfaction was 7 for personal work organisation, 6 for training and for institutional organisation, and only 5 for personal career management. The median of job stress was 5 and was inversely correlated with satisfaction with career management. Respect of autonomy, work-sharing activity between investigation and quality control, a better career progression, financial reward for demanding tasks, and participation in unit staff meetings were the main suggestions to improve employee satisfaction. ConclusionThis nationwide survey provides a new insight into the activity of French clinical research personnel and points to ways to improve the quality and efficiency of this workforce.</div

Additional file 1 of Job description and perception of clinical research personnel working in a network of French intensive care units

Additional file 1. Details of the survey questionnaire

One year after ICU admission for severe community-acquired pneumonia of bacterial, viral or unidentified etiology. What are the outcomes?

Introduction Multiplex polymerase chain reaction (mPCR) for respiratory virus testing is increasingly used in community-acquired pneumonia (CAP), however data on one-year outcome in intensive care unit (ICU) patients with reference to the causative pathogen are scarce. Materials and methods We performed a single-center retrospective study in 123 ICU patients who had undergone respiratory virus testing for CAP by mPCR and with known one-year survival status. Functional status including dyspnea (mMRC score), autonomy (ADL Katz score) and need for new home-care ventilatory support was assessed at a one-year post-ICU follow-up. Mortality rates and functional status were compared in patients with CAP of a bacterial, viral or unidentified etiology one year after ICU admission. Results The bacterial, viral and unidentified groups included 19 (15.4%), 37 (30.1%), and 67 (54.5%) patients, respectively. In multivariate analysis, one-year mortality in the bacterial group was higher compared to the viral group (HR 2.92, 95% CI 1.71–7.28, p = 0.02) and tended to be higher compared to the unidentified etiology group (p = 0.06); but no difference was found between the viral and the unidentified etiology group (p = 0.43). In 64/83 one-year survivors with a post-ICU follow-up consultation, there were no differences in mMRC score, ADL Katz score and new home-care ventilatory support between the groups (p = 0.52, p = 0.37, p = 0.24, respectively). Severe dyspnea (mMRC score = 4 or death), severe autonomy deficiencies (ADL Katz score ≤ 2 or death), and major adverse respiratory events (new home-care ventilatory support or death) were observed in 52/104 (50.0%), 47/104 (45.2%), and 65/104 (62.5%) patients, respectively; with no difference between the bacterial, viral and unidentified group: p = 0.58, p = 0.06, p = 0.61, respectively. Conclusions CAP of bacterial origin had a poorer outcome than CAP of viral or unidentified origin. At one-year, impairment of functional status was frequently observed, with no difference according to the etiology. </jats:sec

SARS-CoV2 pneumonia patients admitted to the ICU: Analysis according to clinical and biological parameters and the extent of lung parenchymal lesions on chest CT scan, a monocentric observational study

International audienceBackground CT-scan and inflammatory and coagulation biomarkers could help in prognostication of COVID-19 in patients on ICU admission. Objective The objectives of this study were to measure the prognostic value of the extent of lung parenchymal lesions on computed tomography (CT) and of several coagulation and inflammatory biomarkers, and to explore the characteristics of the patients depending on the extent of lung parenchymal lesions. Design Retrospective monocentric observational study achieved on a dataset collected prospectively. Setting Medical ICU of the university hospital of Clermont-Ferrand, France. Patients All consecutive adult patients aged ≥18 years admitted between 20 March, 2020 and 31 August, 2021 for COVID-19 pneumonia. Interventions Characteristics at baseline and during ICU stay, and outcomes at day 60 were recorded. The extent of lung parenchyma lesions observed on the chest CT performed on admission was established by artificial intelligence software. Measurements Several clinical characteristics and laboratory features were collected on admission including plasma interleukin-6, HLA-DR monocytic–expression rate (mHLA-DR), and the extent of lung parenchymal lesions. Factors associated with day-60 mortality were investigated by uni- and multivariate survival analyses. Results 270 patients were included. Inflammation biomarkers including the levels of neutrophils, CRP, ferritin and Il10 were the indices the most associated with the severity of the extent of the lung lesions. Patients with more extensive lung parenchymal lesions (≥ 75%) on admission had higher CRP serum levels. The extent of lung parenchymal lesions was associated with a decrease in the PaO2/FiO2 ratio(p&lt;0.01), fewer ventilatory-free days (p = 0.03), and a higher death rate at day 60(p = 0.01). Extent of the lesion of more than 75% was independently associated with day-60 mortality (aHR = 1.72[1.06; 2.78], p = 0.03). The prediction of death at day 60 was improved when considering simultaneously biological and radiological markers obtained on ICU admission (AUC = 0.78). Conclusions The extent of lung parenchyma lesions on CT was associated with inflammation, and the combination of coagulation and inflammatory biomarkers and the extent of the lesions predicted the poorest outcomes

One year after ICU admission for severe community-acquired pneumonia of bacterial, viral or unidentified etiology. What are the outcomes?

IntroductionMultiplex polymerase chain reaction (mPCR) for respiratory virus testing is increasingly used in community-acquired pneumonia (CAP), however data on one-year outcome in intensive care unit (ICU) patients with reference to the causative pathogen are scarce.Materials and methodsWe performed a single-center retrospective study in 123 ICU patients who had undergone respiratory virus testing for CAP by mPCR and with known one-year survival status. Functional status including dyspnea (mMRC score), autonomy (ADL Katz score) and need for new home-care ventilatory support was assessed at a one-year post-ICU follow-up. Mortality rates and functional status were compared in patients with CAP of a bacterial, viral or unidentified etiology one year after ICU admission.ResultsThe bacterial, viral and unidentified groups included 19 (15.4%), 37 (30.1%), and 67 (54.5%) patients, respectively. In multivariate analysis, one-year mortality in the bacterial group was higher compared to the viral group (HR 2.92, 95% CI 1.71-7.28, p = 0.02) and tended to be higher compared to the unidentified etiology group (p = 0.06); but no difference was found between the viral and the unidentified etiology group (p = 0.43). In 64/83 one-year survivors with a post-ICU follow-up consultation, there were no differences in mMRC score, ADL Katz score and new home-care ventilatory support between the groups (p = 0.52, p = 0.37, p = 0.24, respectively). Severe dyspnea (mMRC score = 4 or death), severe autonomy deficiencies (ADL Katz score ≤ 2 or death), and major adverse respiratory events (new home-care ventilatory support or death) were observed in 52/104 (50.0%), 47/104 (45.2%), and 65/104 (62.5%) patients, respectively; with no difference between the bacterial, viral and unidentified group: p = 0.58, p = 0.06, p = 0.61, respectively.ConclusionsCAP of bacterial origin had a poorer outcome than CAP of viral or unidentified origin. At one-year, impairment of functional status was frequently observed, with no difference according to the etiology