Identifying potential indicators to measure the outcome of translational cancer research: a mixed methods approach

International audienceAbstractBackgroundIn a context where there is an increasing demand to evaluate the outcome of bio-medical research, our work aims to develop a set of indicators to measure the impact of translational cancer research. The objective of our study was to explore the scope and issues of translational research relevant to evaluation, explore the views of researchers on the evaluation of oncological translational research, and select indicators measuring the outcomes and outputs of translational research in oncology by consensus.MethodsSemi-structured interviews amongst 23 researchers involved in translational cancer research were conducted and analysed using thematic analysis. A two-round modified Delphi survey of 35 participants with similar characteristics was then performed followed by a physical meeting. Participants rated the feasibility and validity of 60 indicators. The physical meeting was held to discuss the methodology of the new indicators.ResultsThe main themes emerging from the interviews included a common definition for translational research but disagreements about the exact scope and limits of this research, the importance of multidisciplinarity and collaboration for the success of translational research, the disadvantages that translational research faces in current evaluation systems, the relative lack of pertinence of existing indicators, and propositions to measure translational cancer research in terms of clinical applications and patient outcomes. A total of 35 participants took part in the first round survey and 12 in the second round. The two-round survey helped us select a set of 18 indicators, including four that seemed to be particularly adapted to measure translational cancer research impact on health service research (number of biomarkers identified, generation of clinical guidelines, citation of research in clinical guidelines, and citation of research in public health guidelines). The feedback from participants helped refine the methodology and definition of indicators not commonly used.ConclusionIndicators need to be accepted by stakeholders under evaluation. This study helped the selection and refinement of indicators considered as the most relevant by researchers in translational cancer research. The feasibility and validity of those indicators will be tested in a scientometric study

The Intestinal Gas Questionnaire (IGQ): Psychometric validation of a new instrument for measuring gas-related symptoms and their impact on daily life among general population and irritable bowel syndrome

Gas-related symptoms; Patient-reported outcomes; Quality of lifeSíntomas relacionados con los gases; Resultados informados por el paciente; Calidad de vidaSímptomes relacionats amb els gasos; Resultats informats pel pacient; Qualitat de vidaBackground Gas-related symptoms (GRS) are common in the general population (GPop) and among patients with disorders of gut-brain interactions but there is no patient-reported outcome evaluating these symptoms and their impact on daily life. We have previously developed a 43-item intestinal gas questionnaire (IGQ). The aim of the present study is to perform a psychometric validation of this instrument. Methods Participants (119 from the GPop and 186 irritable bowel syndrome (IBS) patients) were recruited from 3 countries (UK, Spain, France). IBS patients fulfilled ROME IV criteria with an IBS severity score between 150 and 300. Participants completed the IGQ, the functional Digestive Disorders Quality of Life (FDDQL), and the EQ-5D. A subgroup (n = 90) repeated the IGQ completion after 7 days on paper or electronically. Results From the original IGQ questionnaire, 26 items were deleted because of poor performance. Confirmatory factorial analysis on the remaining 17 items (7 symptom and 10 impact items) yielded a 6-factor structure accounting for 67% of the variance for bloating (6 items), flatulence (3), belching (2), bad breath (2), stomach rumbling (2), and difficult gas evacuation (2). Global score (0-100) was worse among IBS vs GPop (40 ± 15 vs 33 ± 17; p = 0.0016). At the second visit, the intraclass correlation coefficient of IGQ scores was between 0.71 and 0.86 (n = 67) for test-retest reliability and 0.61-0.87 (n = 64) for equivalence between electronic and paper versions of IGQ. Conclusion The IGQ available in paper and electronic versions in 3 languages is a robust instrument for capturing and measuring GRS and their impact on daily life.This Investigator Sponsored Study has been funded by Danone Research. Danone did not interfere with the analysis and interpretation of data. The work was supported in part by the Spanish Ministry of Economy and Competitiveness (Dirección General de Investigación Científica y Técnica, SAF 2016-76648-R). Ciberehd is funded by the Instituto de Salud Carlos II

The Intestinal Gas Questionnaire (IGQ) : Psychometric validation of a new instrument for measuring gas-related symptoms and their impact on daily life among general population and irritable bowel syndrome

Gas-related symptoms (GRS) are common in the general population (GPop) and among patients with disorders of gut-brain interactions but there is no patient-reported outcome evaluating these symptoms and their impact on daily life. We have previously developed a 43-item intestinal gas questionnaire (IGQ). The aim of the present study is to perform a psychometric validation of this instrument. Participants (119 from the GPop and 186 irritable bowel syndrome (IBS) patients) were recruited from 3 countries (UK, Spain, France). IBS patients fulfilled ROME IV criteria with an IBS severity score between 150 and 300. Participants completed the IGQ, the functional Digestive Disorders Quality of Life (FDDQL), and the EQ-5D. A subgroup (n = 90) repeated the IGQ completion after 7 days on paper or electronically. From the original IGQ questionnaire, 26 items were deleted because of poor performance. Confirmatory factorial analysis on the remaining 17 items (7 symptom and 10 impact items) yielded a 6-factor structure accounting for 67% of the variance for bloating (6 items), flatulence (3), belching (2), bad breath (2), stomach rumbling (2), and difficult gas evacuation (2). Global score (0-100) was worse among IBS vs GPop (40 ± 15 vs 33 ± 17; p = 0.0016). At the second visit, the intraclass correlation coefficient of IGQ scores was between 0.71 and 0.86 (n = 67) for test-retest reliability and 0.61-0.87 (n = 64) for equivalence between electronic and paper versions of IGQ. The IGQ available in paper and electronic versions in 3 languages is a robust instrument for capturing and measuring GRS and their impact on daily life. Intestinal Gas Quesitonnaire (IGQ): a new tool to measure Gas-Related Symptoms and their impact on daily life

Benchmarking facilities providing care: An international overview of initiatives

We performed a literature review of existing benchmarking projects of health facilities to explore (1) the rationales for those projects, (2) the motivation for health facilities to participate, (3) the indicators used and (4) the success and threat factors linked to those projects. We studied both peer-reviewed and grey literature. We examined 23 benchmarking projects of different medical specialities. The majority of projects used a mix of structure, process and outcome indicators. For some projects, participants had a direct or indirect financial incentive to participate (such as reimbursement by Medicaid/Medicare or litigation costs related to quality of care). A positive impact was reported for most projects, mainly in terms of improvement of practice and adoption of guidelines and, to a lesser extent, improvement in communication. Only 1 project reported positive impact in terms of clinical outcomes. Success factors and threats are linked to both the benchmarking process (such as organisation of meetings, link with existing projects) and indicators used (such as adjustment for diagnostic-related groups). The results of this review will help coordinators of a benchmarking project to set it up successfully

Tendances et évolutions de la recherche française sur le cancer du sein : étude bibliométrique

National audienceThis article presents a bibliometric study carried out in order to describe the trends and evolutions of French breast cancer research from 2003 to 2013. The results show an increase in the number of publications, especially international publications coordinated by non-French institutions. The most visible topics, in terms of number of publications by keywords, are related to biology, clinical trials and genetics. Most publications are written by authors affiliated to comprehensive cancer centres, followed by universities, research centres, university hospitals and governmental agencies. The importance of publications by topic varies throughout the years: there has been an increase of the number of publications related to targeted therapies or genomics. The importance of institutions or country affiliation of authors varies with the topics. This study, especially the analysis by keywords, enables the coordinators of research programs to identify the predominant actors and themes.Cet article présente une étude bibliométrique réalisée afin de décrire les tendances et évolutions de la recherche française contre le cancer du sein de 2003 à 2013. Les résultats montrent une augmentation du nombre de publications, notamment des publications internationales coordonnées par des institutions étrangères. Les thématiques les plus visibles, en termes de nombre de publications par mots clés concernent la biologie, les essais cliniques, la chimiothérapie, les facteurs de risque et la génétique. La majorité des publications est rédigée par des auteurs issus de centres de lutte contre le cancer, suivis de près par des universités, puis par des centres de recherche, centres hospitalo-universitaires et agences gouvernementales. Le poids des publications par thématique varie selon les années : on constate notamment une augmentation du nombre de publications liées aux thérapies ciblées et à la génomique. L’importance des institutions et des pays d’affiliation des auteurs varie selon les thématiques. Cette étude, et notamment l’analyse à partir des mots clés, peut permettre aux coordinateurs de programmes de recherche d’identifier les acteurs et thématiques principales

Outcomes used in randomised controlled trials of nutrition in the critically ill: a systematic review

International audienceBackground: No evidence exists to date on which to base the selection of outcome measures for assessing nutritional interventions in critically ill patients. We conducted a systematic literature review to describe the outcomes used in recent randomised controlled trials (RCTs) assessing nutritional interventions in critically ill patients. Our objective was to set the foundation for the development of a core set of outcome measures for use in future RCTs.Methods: We searched the PubMed/MEDLINE, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases for RCTs of nutritional interventions in critically ill patients aged 18 years or older, published and/or registered between January 2000 and August 2018. Outcomes were divided into six categories (mortality, length of stay, duration of organ dysfunction, complications, functional outcomes, and others) and analysed according to the study characteristics and publication year.Results: Of the 885 references retrieved, 170 were included in the review. Of these, 136 (80%) defined a primary outcome, 114 (67%) defined secondary outcomes (two per study on average), and 34 (20%) did not specify whether outcomes were primary or secondary. We identified 24 different outcomes in all, of which 19 were primary. Complications were the most widely used primary outcome (65/136, 48%). Mortality was the primary outcome in 17/136 (13%) studies, with six different timepoints. The main secondary outcomes were length of stay (90/114, 79%), mortality (82/114, 72%), and duration of organ dysfunction (75/114, 65%).Conclusions: This systematic review highlights the heterogeneity of outcomes used in recent randomized controlled trials evaluating nutritional interventions in critically ill patients. The results of our systematic review may have implications for designing future RCTs of nutritional interventions in the ICU

Questioning the "Ease" in disease: Was living with HIV a burden or boost during the first wave of Covid-19 in France? A qualitative study (COVIDHIV).

IntroductionClinical research has focused on risk factors and treatment for severe acute respiratory syndrome coronavirus 2 (SARS-COV-2), particularly in people with a comorbidity including the human immunodeficiency virus (HIV), but little attention has been paid to the care pathway. This article aims to show how living with HIV may have been a biopsychosocial burden or boost in care pathways for Covid-19.MethodPeople living with HIV (PLHIV) from 9 clinical centers were invited to participate in this qualitative study. The sampling was purposive with a maximum variation in their sociodemographic profiles. Semi-structured interviews were conducted until data saturation, then coded for thematic analysis, using an inductive general approach.ResultsWe interviewed 34 PLHIV of which 20 had SARS-COV-2 once. They were 24 males, 26 born in France; median age: 55. Twenty had a CD4 number above 500, and all were on antiretroviral therapy (ART). HIV appeared as a burden when Covid-19 symptoms reminded HIV seroconversion, fear of contamination, and triggered questions about ART effectiveness. HIV was not considered relevant when diagnosing Covid-19, caused fear of disclosure when participants sought SARS-COV-2 testing, and its care in hospitals was disrupted by the pandemic. ART-pill fatigue caused avoidance for Covid-19 treatment. As a boost, living with HIV led participants to observe symptoms, to get advice from healthcare professionals, and screening access through them. Some participants could accept the result of screening or a clinical diagnosis out of resilience. Some could consider ART or another drug prescribed by their HIV specialist help them to recover from Covid-19.ConclusionLiving with HIV could function as a burden and/or a boost in the care pathways for Covid-19, according to patients' relationship to their HIV history, comorbidities and representation of ART. Covid-19 in PLHIV needs further qualitative study to gain a more comprehensive assessment of the pandemic's consequences on their lives and coping strategies

« Un bien pour un mal ». Consommation et arrêt du tabac chez les migrants en France : une étude qualitative (TATAMI)

International audienceIntroduction: The aim of this study is to identify factors related to smoking and smoking cessation as well as preferences for cessation methods reported by migrants in France.Methods: Qualitative study using semi-directive interviews with migrants in the Parisian area thematically analyzed using an inductive approach.Results: Sixteen interviews conducted. The stress and isolation induced by migration favor the increase of tobacco consumption. These two factors, as well as the lack of information on the resources available for quitting smoking, were identified as obstacles to cessation. The main motivations for quitting are the identified or experienced effects of smoking on their health and pressure from family members, especially children. Quitting is essentially a personal strategy centered on the true will to quit. The most popular method identified by the participants as the most effective in helping them to quit, is follow-up or therapy by a health professional combining listening and psychological support.Discussion: For migrants, smoking is a resource to combat stress that increases during the migration process and upon arrival in the host country and presents a psychosocial dimension for the most isolated individuals. Smoking cessation must be accompanied and must take into account the specificities of this population as well as the expressed need for psychosocial support, as suggested by our results, to be most effective.IntroductionThe aim of this study is to identify factors related to smoking and smoking cessation as well as preferences for cessation methods reported by migrants in France.MethodsQualitative study using semi-directive interviews with migrants in the Parisian area thematically analyzed using an inductive approach.ResultsSixteen interviews conducted. The stress and isolation induced by migration favor the increase of tobacco consumption. These two factors, as well as the lack of information on the resources available for quitting smoking, were identified as obstacles to cessation. The main motivations for quitting are the identified or experienced effects of smoking on their health and pressure from family members, especially children. Quitting is essentially a personal strategy centered on the true will to quit. The most popular method identified by the participants as the most effective in helping them to quit, is follow-up or therapy by a health professional combining listening and psychological support.DiscussionFor migrants, smoking is a resource to combat stress that increases during the migration process and upon arrival in the host country and presents a psychosocial dimension for the most isolated individuals. Smoking cessation must be accompanied and must take into account the specificities of this population as well as the expressed need for psychosocial support, as suggested by our results, to be most effective