Outpatient healthcare and clinical trials in the care pathway: Organisational and regulatory aspects and tools.

Clinical research in outpatient healthcare, particularly in general practice, which is the first line of contact with the population, is now a public health issue. However, this type of research has specific characteristics that differentiate it from clinical research conducted in a hospital setting and requires an adaptation of its conditions of practice: in terms of organisation, the development of research in outpatient healthcare relies on the appropriation of its fundamentals by the investigators, which implies their presentation, upstream, from the initial cycle, and the participation of practitioners in training modules adapted to research in primary care, such as those already organised by several GIRCI (Groupement Inter régional de la Recherche Clinique et de l'Innovation [French Interregional Clusters for Clinical Research and Innovation]). To compensate for the fragmented nature of their location, on the model of the EMRCs (équipes mobiles de recherche clinique [mobile clinical research teams]) in oncology, mobile research teams should enable general medical practices to participate in clinical trials. This presupposes, on the one hand, the allocation of earmarked funding to ensure the sustainability of a base of dedicated personnel and, on the other hand, the impetus of a national dynamic through the setting up of a multi-organisation thematic institute for "research in primary care" associated, at the operational level, with a national scale investigation network supported by a platform of excellence. The use of digital tools and innovations (telemedicine; data collection via connected tools; e-consent; electronic signature) which make it possible to digitise and relocate all or part of the research procedures for both the participant and the investigation teams. An adaptation of the legal framework in order to bring the place of research closer to the patient and not the other way round, which means moving the equipment and investigations closer to the patient. Taking into account the acceptability of the patient, thus limiting the disruption that may be caused by his or her participation in a research protocol and motivating the practitioner by valuing his or her contribution and providing all the guarantees of scientific relevance and independence of practice. In view of the contextual analysis, positive feedback and the availability of organisational and digital support points facilitating the delocalisation and digitisation of the conduct of research activity as close as possible to the patient and his or her doctor, the round table concluded that opportunities exist today which favour the development of clinical research in general practice. It is important to seize this opportunity and make the most of it without delay.

Changes in prostate cancer screening practice by blood PSA testing between 2011 and 2017, a French population-based study.

OBJECTIVE: The aim of the study was to determine the trend of first blood prostate-specific antigen (PSA) test prescription in France between 2011 and 2017, based on the assumption that prostate cancer (PCa) screening is expected to decline over the years. METHOD: Using a representative sample of the French population from the French Health Insurance database, we identified 50-52-year-old men without PCa and without any blood PSA test in the five years before 2011, 2014 and 2017 (January 1-December 31 of each year). For each of these three years, the primary outcome was the first reimbursement of a blood PSA test. We used a logistic regression model with first blood PSA test as the outcome and year as the main explanatory variable. As secondary objectives, we also identified the prescriber's specialty, the urological consultation frequency, and the number of prostate biopsies in the year after the first blood PSA test reimbursement (only for 2011 and 2014). RESULTS: In 2011, 2014 and 2017, 5 275, 5 792 and 5 887 50-52-year-old men, respectively, were included. The percentage of patients with a first blood PSA test prescription decreased linearly from 2011 to 2017: 15.7% in 2011, 13.2% in 2014, and 12.4% in 2017 (p < .001). Blood PSA testing was mainly prescribed by general practitioners (>95%). The median interval between PSA tests was 13 months in 2011 and 14 months in 2014. Fewer than 10% of men had ≥1 consultation with an urologist during the year after the first blood PSA test. After the first blood PSA test, eight prostate biopsies were performed in 2011 and two in 2014. CONCLUSION: Our results suggest that in France, PCa screening is a primary care issue. Although PCa screening remains controversial and confusion exists about the best practice, our study showed a linear decrease of blood PSA test prescriptions for 50-52-year-old men between 2011 and 2017, although the reason for screening was unknown. As clinical information was not available, additional evidence is needed to determine the real impact of this decrease on the cancer-specific and overall mortality.

Use of the COPD Assessment Test (CAT) to screen for COPD in dairy farmers: AIRBAg study.

OBJECTIVES: People at risk of chronic obstructive pulmonary disease (COPD) can benefit from appropriate medical management before severe symptoms appear. This study assesses the value of the COPD Assessment Test (CAT) questionnaire for screening dairy farmers, who tend to be slow or reluctant to seek health care. METHODS: During the time period 2012-2017, 2089 randomly selected dairy farmers in Brittany (France) were invited to complete self-administered questionnaires (including the CAT) and to undergo an occupational health check-up using an electronic mini-spirometer and conventional spirometry. Those showing symptoms suggestive of COPD and/or a ratio FEV1 /FEV6 < 80% were sent to a pulmonologist for a further check-up, including spirometry with a reversibility test. Multivariate logistic models based on CAT scores and socio-demographic or work-related factors were developed to predict COPD. RESULTS: The 1231 farmers who underwent the occupational health check-up included 1203 who met the inclusion/exclusion criteria. Pulmonologist identified 16 (1.3%) cases of COPD. A multivariate logistic regression model (covariates: CAT sum score, on-farm time, BMI, smoking status, free-stall mulching) provided an area under the receiver-operating characteristic curve (AUC) of 0.87 (95% CI: 0.75-0.98). Using a cut-off of 0.007 gave a sensitivity of 93.8% and a specificity of 62.4%. Another model that included CAT breathlessness and the same covariates performed marginally better (AUC = 0.88, 95% CI: 0.77-0.98). CONCLUSION: Our predictive models can both benefit dairy farmers by providing early diagnosis and management of their COPD and avoid unnecessary, costly spirometry during the screening process.

Adverse events of targeted therapies reported by patients with cancer treated in primary care.

BACKGROUND: Targeted Therapies (TT) are among the therapeutic innovations for cancer treatment in outpatient settings. TT-related Adverse Events (AEs) are a source of loss of opportunity for patients if their management is inappropriate. OBJECTIVES: The objective of this study was to describe the AE frequency and severity as reported by patients with cancer who received TT in ambulatory settings. A second objective was to describe the role of the general practitioner (GP) in the management of AEs. METHODS: All patients who started TT at a French Regional Cancer Centre in 2017-2018 were eligible for this 12-month prospective study. A self-administered questionnaire was distributed at inclusion and returned after three months. In the questionnaire, patients listed all AEs that occurred during this period and rated their severity. Occurrence and severity were compared with the rating by a specialised nurse. Patients also indicated the health professional they contacted first for the reported AE. RESULTS: Among the 247 eligible patients, 15 were excluded and 144 responded to the questionnaire. Fourteen different TTs have been prescribed. Asthenia (92.4%) and anorexia (64.6%) were the most frequent AE. Patients' AE severity rating was more severe than the nurse's rating for all drugs (p < 0.001). Patients first contacted their GP for 15.6% of AEs, whereas 20.7% of AEs were not reported to any health professional. CONCLUSION: Patients experienced an average of 4 AEs. AE severity rating was significantly different between patients and nurses. Patients do not always communicate AEs to health care professionals.

Association between gifts from pharmaceutical companies to French general practitioners and their drug prescribing patterns in 2016: retrospective study using the French Transparency in Healthcare and National Health Data System databases.

OBJECTIVE: To evaluate the association between gifts from pharmaceutical companies to French general practitioners (GPs) and their drug prescribing patterns. DESIGN: Retrospective study using data from two French databases (National Health Data System, managed by the French National Health Insurance system, and Transparency in Healthcare). SETTING: Primary care, France. PARTICIPANTS: 41 257 GPs who in 2016 worked exclusively in the private sector and had at least five registered patients. The GPs were divided into six groups according to the monetary value of the received gifts reported by pharmaceutical, medical device, and other health related companies in the Transparency in Healthcare database. MAIN OUTCOME MEASURES: The main outcome measures were the amount reimbursed by the French National Health Insurance for drug prescriptions per visit (to the practice or at home) and 11 drug prescription efficiency indicators used by the National Health Insurance to calculate the performance related financial incentives of the doctors. Doctor and patient characteristics were used as adjustment variables. The significance threshold was 0.001 for statistical analyses. RESULTS: The amount reimbursed by the National Health Insurance for drug prescriptions per visit was lower in the GP group with no gifts reported in the Transparency in Healthcare database in 2016 and since its launch in 2013 (no gift group) compared with the GP groups with at least one gift in 2016 (-€5.33 (99.9% confidence interval -€6.99 to -€3.66) compared with the GP group with gifts valued at €1000 or more reported in 2016) (P<0.001). The no gift group also more frequently prescribed generic antibiotics (2.17%, 1.47% to 2.88% compared with the ≥€1000 group), antihypertensives (4.24%, 3.72% to 4.77% compared with the ≥€1000 group), and statins (12.14%, 11.03% to 13.26% compared with the ≥€1000 group) than GPs with at least one gift between 2013 and 2016 (P<0.001). The no gift group also prescribed fewer benzodiazepines for more than 12 weeks (-0.68%, -1.13% to -0.23% compared with the €240-€999 group) and vasodilators (-0.15%, -0.28% to -0.03% compared with the ≥€1000 group) than GPs with gifts valued at €240 or more reported in 2016, and more angiotensin converting enzyme (ACE) inhibitors compared with all ACE and sartan prescriptions (1.67%, 0.62% to 2.71%) compared with GPs with gifts valued at €1000 or more reported in 2016 (P<0.001). Differences were not significant for the prescription of aspirin and generic antidepressants and generic proton pump inhibitors. CONCLUSION: The findings suggest that French GPs who do not receive gifts from pharmaceutical companies have better drug prescription efficiency indicators and less costly drug prescriptions than GPs who receive gifts. This observational study is susceptible to residual confounding and therefore no causal relation can be concluded. TRIAL REGISTRATION: OSF register OSF.IO/8M3QR.