Communication and sexual function and frequency in breast cancer patients 2 years after diagnosis: results from the VICAN 2 study.

BACKGROUND: Breast cancer treatments may have impacts on several aspects of sexual health, including psychological, psychosexual, physiological, physical, and relational. AIM: In this study we sought to assess sexual function and sexual frequency in breast cancer patients 2 years after diagnosis. METHODS: We selected all breast cancer participants from the the French national VIe après le CANcer 2 (VICAN 2) longitudinal study. Data sources included patient and medical questionnaires, along with medico-administrative databases. OUTCOMES: Outcomes assessed were the dimensions of sexual function and frequency from the Relationship and Sexuality Scale and communication about sexuality with healthcare providers. RESULTS: Out of 1350 participating women, 60.2% experienced a decrease in sexual desire, 61.4% reported a lower frequency of intercourse, and 49.5% faced decreased ability to orgasm. In contrast, 64.8% had engaged in sexual intercourse in the previous 2 weeks, 89.5% were "Somewhat" to "Very much" satisfied with the frequency of intimate touching and kisses with their partner, and 81.6% expressed satisfaction with their intercourse frequency. However, a mere 15% of women discussed sexuality with the healthcare providers. Independent factors associated with increased communication about sexuality included age younger than 50 years (OR = 1.90 95% CI [1.28-2.82], P = .001), being in a partner relationship (OR = 2.53 95% CI [1.28-2.82], P = .003), monthly income above 1,500 euros (OR = 1.73 95% CI [1.15-2.60], P = .009), and absence of diabetes (OR = 6.11 95% CI [1.39-26.93], P = .017). CLINICAL TRANSLATION: The study findings underscore the need for continuing education in oncosexology and dedicated sexual health interventions that should involve a holistic approach that takes into consideration age, treatments, relationship status, and whether the patient has diabetes. STRENGTHS AND LIMITATIONS: Strengths of the study are the sample size, the national representativeness, and data reliability. However, the cross-sectional design could introduce potential recall, recency, or social desirability biases. Also, social determinants influencing sexual health, such as ethnicity or geographic locations, have not been considered in the analyses. CONCLUSIONS: This study revealed that sexual disorders persist 2 years after a breast cancer diagnosis, with a noticeable communication gap regarding sexuality between patients and medical teams. These findings underscore the necessity for tailored sexual health interventions, particularly designed for women who are single, older aged, and diabetes patients.

STABILISE (Stent-Assisted Balloon-Induced Intimal Disruption and Relamination in Aortic Dissection Repair) Is Associated With Good Anatomical Results on the Distal Thoracoabdominal Aorta at 2 Years.

PURPOSE: The aim of this comparative study was to evaluate the increased aortic diameter of the distal aorta after implementing the STABILISE technique in complicated type B aortic dissection (AD). DESIGN: This is a comparative monocentric retrospective study. MATERIALS AND METHODS: All patients who underwent an STABILISE procedure for complicated AD between 2018 and 2020 were included and compared with a historic cohort treated with thoracic endovascular aortic repair (TEVAR) alone. Aortic diameters were measured at 6 different levels on the thoracic and abdominal aorta. The primary end point was an increased aortic diameter at 1 and 2 years. The exclusion criterion was the absence of a computed tomography (CT) scan at 1 or 2 years. RESULTS: A total of 55 patients were included: 24 in the TEVAR group and 31 in the STABILISE group. At the level of the stent graft, there was a decrease in aortic diameters in both groups without significant differences. At the level of the distal aorta, there was an increase in aortic diameters in both groups without significant differences. There were significantly more patients in the TEVAR group with an unfavorable increase in aortic diameter >5 mm of the distal aorta at 2 years than in the STABILISE group: 8 (33%) vs 1 (3%) (p=0.01). For chronic ADs, a significantly greater increase in aortic diameters of the distal aorta was observed in the STABILISE group. CONCLUSIONS: The STABILISE technique is technically feasible and potentially leads to decreased longer re-intervention rates; indeed, more patients had an unfavorable increase in aortic diameter in the TEVAR group than in the STABILISE group at 2 years. The high rate of long-term distal aortic aneurysm progression and reintervention after TEVAR alone suggests that this option is not sufficient to definitively treat these complex patients. CLINICAL IMPACT: This article reported the results of stent assisted balloon induced intimal disruption and relamination (STABILISE) with a follow-up at 2 years. This is the first comparative study between STABILISE, which has emerged as a new technique inducing aortic remodeling and therefore better long-term outcome, and the standard technique TEVAR alone. STABILISE technique is associated with good results on the distal aorta at 2 years with a rate of patient with unfavorable aortic diameter evolution greater in TEVAR group compared to STABILISE group and could improve the long-term results on the distal aorta by inducing extensive aortic remodeling.

Socioeconomic and cultural factors associated with pap smear screening among French women living in Réunion Island.

BACKGROUND: Réunion Island is a French overseas territory located in the southern Indian Ocean, with a challenging socioeconomic and multicultural context. Compared to mainland France, Réunion has an overincidence and overmortality of cervical cancer. In order to investigate these two issues, it is important to evaluate the barriers and potential levers to Pap smear screening among female inhabitants of the island. We aimed to identify the specific socio-demographic factors, cultural factors, and living conditions associated with Pap smear screening in Réunion, with a view to increasing uptake. METHODS: We conducted a Knowledge Attitude Behavior and Practices (KABP) survey on cervical cancer screening practices among women aged between 25 and 65 years old living in Réunion Island, selected using random digit dialing sampling. Data were collected using Computer Assistant Telephone Interviews. Weighted chi-squared tests and Student's t-tests were used to compare women who had up-to-date Pap smear screening with women who did not. Weighted logistic models were used to identify the factors associated with not having up-to-date screening. RESULTS: A total of 1000 women were included in the study. Of these, 88.1% had a Pap smear test during the previous three years. Factors independently associated with not being up to date were as follows: aged over 55 (AOR 2.3 [1.2-4.3]), no children (AOR 2.5 [1.4-4.3]), having free universal health coverage (AOR 1.7 [1.1-2.7]), an income per unit consumption lower than 1500€ per month (AOR 2.0 [1.1-3.7]), low health literacy (AOR 2.7 [1.7-4.1]), not consulting a general practitioner in the prior 12 months (AOR 3.6 [2.0-6.5]), and a BMI > 30 (AOR 2.6 [1.5-4.4]). CONCLUSIONS: This is the first large-scale survey focusing on recommended Pap smear screening uptake in Réunion Island. Although self-reported screening incidence was higher than in mainland France, national screening policies must take into account the island's diverse social and cultural characteristics (e.g., an ageing population, low health literacy), while implementing actions to fight against poverty and increase general access to healthcare.

Entre santé et science : littératie en santé et perception de la recherche médicale.

OBJECTIVE: Biomedical innovation plays an important role in health care pathways and public debates. Nevertheless, existing measures of health literacy take little account of medical research. In this article, we explore the relationship between health literacy and attitudes toward medical research, from clinical trials to more general attitudes toward science. METHODS: We analyze the results of two self-administered questionnaires conducted on samples of the French adult population in 2020 and 2021 (N=2003 and N=2022). A series of twelve questions assessed health literacy (HLS19-Q12-EN) and ten questions addressed attitudes to clinical trials, medical research, and science in general. The analyses characterize the population’s perception of medical research issues and its association with health literacy. RESULTS: There is a significant association between health literacy and perception of research. A low level of literacy is associated with lower knowledge of clinical trials and a more negative attitude toward them, less confidence in science and its contributions to society. CONCLUSIONS: Given the continuity between care and research, health literacy is likely to be a relevant measure for characterizing disparity in attitudes toward clinical trials and improving access to innovation.

The Left Outflow Tract in Fetal Cardiac Screening Examination: Introduction of Quality Criteria Is Not Always Associated With an Improvement of Practice When Supervised by Humans.

OBJECTIVES: Since 2016, the French CNEOF included the left ventricular outflow tract (LVOT) in the second and third trimester of pregnancy in addition to the four-chamber view and the parasagittal view of the right outflow tract. The objective of this study was to define quality criteria for fetal LVOT assessment and to perform a human audit of past and current practices, before and after the implementation of those quality criteria at a large scale. METHODS: Seven quality criteria were investigated and rated from 0 to 1 during three periods of interest. Files were randomly selected from three centers, and average total and specific scores were calculated. RESULTS: LVOT pictures were present in more than 94.3% of reports. The average quality score was 5.49/7 (95% confidence interval [CI]: 5.36-5.62), 5.91/7 (95% CI: 5.80-6.03), and 5.70/7 (95% CI: 5.58-5.82) for the three centers in the three periods of interest. There was no significant difference following the introduction of the quality criteria, 2017 versus 2020, P = .054. CONCLUSION: Fetal LVOT images were present in most of ultrasound reports but the introduction of the proposed quality criteria under human supervision seems not associated with a significant change in practice.

The French General Population's Perception of New Information and Communication Technologies for Medical Consultations: National Survey.

BACKGROUND: The development of telehealth and telemedicine, in the form of increased teleconsultation and medical telemonitoring, accelerated during the COVID-19 health crisis in France to ensure continued access to care for the population. Since these new information and communication technologies (ICTs) are diverse and likely to transform how the health care system is organized, there is a need better to understand public attitudes toward them and their relationship with peoples' current experience of health care. OBJECTIVE: This study aimed to determine the French general population's perception of the usefulness of video recording/broadcasting (VRB) and mobile Health (mHealth) apps for medical consultations in France during the COVID-19 health crisis and the factors associated with this perception. METHODS: Data were collected for 2003 people in 2 waves of an online survey alongside the Health Literacy Survey 2019 (1003 in May 2020 and 1000 in January 2021) based on quota sampling. The survey collected sociodemographic characteristics, health literacy levels, trust in political representatives, and perceived health status. The perceived usefulness of VRB in medical consultations was measured by combining 2 responses concerning this technology for consultations. The perceived usefulness of mHealth apps was measured by combining 2 responses concerning their usefulness for booking doctor appointments and for communicating patient-reported outcomes to doctors. RESULTS: The majority (1239/2003, 62%) of respondents considered the use of mHealth apps useful, while only 27.6% (551/2003) declared VRB useful. The factors associated with the perceived usefulness of both technologies were younger age (≤ 55 years), trust in political representatives (VRB: adjusted odds ratio [aOR] 1.68, 95% CI 1.31-2.17; mHealth apps: aOR 1.88, 95% CI 1.42-2.48), and higher (sufficient and excellent) health literacy. The period of the beginning of the COVID-19 epidemic, living in an urban area, and being limited in daily activities were also associated with perceiving VRB positively. The perceived usefulness of mHealth apps increased with the level of education. It was also higher in people who had 3 or more consultations with a medical specialist. CONCLUSIONS: There are important differences in attitudes toward new ICTs. Perceived usefulness was lower for VRB than for mHealth apps. Moreover, it decreased after the initial months of the COVID-19 pandemic. There is also the possibility of new inequalities. Hence, despite the potential benefits of VRB and mHealth apps, people with low health literacy considered them to be of little use for their health care, possibly increasing their difficulties in accessing health care in the future. As such, health care providers and policy makers need to consider those perceptions to guarantee that new ICTs are accessible and beneficial to all.

Treatment of 120 adult osteosarcoma patients with metachronous and synchronous metastases: A retrospective series of the French Sarcoma Group.

Treatment options for metastatic osteosarcomas are scarce. Following failure of standard first line therapy, patients who relapse present a challenging treatment dilemma, and have a poor prognosis. Surgical removal of all metastases is essential. A retrospective analysis of patients with metastatic osteosarcomas was conducted in 15 French Sarcoma Group centers. From January 2009 to December 2018, we identified 120 adult patients; 36 with synchronous and 84 with metachronous metastases with 74 males and 46 females. Mean age was 30 years (18-53). Metastatic sites were lung, bone and other in 91, 11 and 24 patients, respectively. Mean time to first metachronous metastases was 22 months (4-97). All patients except 13 (10.8%) with metachronous metastases received a first line systemic treatment for relapse, and 39 patients (32.5%) were included in a clinical trial. Eighty-one patients (67.5%) had local treatment of distant metastases. Median progression free survival (PFS) and overall survival (OS) were 5.5 (95% CI 4.6-6.4) and 20.5 months (95% CI 13.2-27.7) respectively for the overall group. In multivariate analysis, more than five metastases, time to first metastases <24 months, were statistically significant negative prognostic factors for OS and PFS (P = .002, ≤.001 and P = .006, ≤.001, respectively). Surgery of metastases was associated with better prognosis on OS and PFS (P = .001 and .037, respectively). The presence of bone metastases was a negative prognostic factor on OS but not on PFS (P = .021). In reference sarcoma centers, relapsed osteosarcoma patients with more than one metastasis commonly receive more than one line of systemic therapy, and are included in clinical trial if available.

Risk Factors for Incomplete Aortic Remodeling With Stent-Assisted Balloon-Induced Intimal Disruption and Relamination in Aortic Dissection Repair for Complicated Aortic Dissection: Results of a Multicenter Study.

PURPOSE: The STABILISE technique has extended the treatment of aortic dissection to the thoracoabdominal aorta to achieve complete aortic remodeling. The aim of this multicenter study was to analyze the short- and midterm anatomical results of the STABILISE technique. MATERIALS AND METHODS: We retrospectively analyzed patients treated with the STABILISE technique for complicated aortic dissection at 3 French academic centers. The aortic diameter at different levels was measured preoperatively, postoperatively, and at 1 year. RESULTS: Between 2018 and 2020, 58 patients, including 47 men (average patient age: 60±11 years), were treated for type B aortic dissection in 34 cases and residual aortic dissection after type A repair in 24 cases. Three (5.2%) patients died postoperatively. Complete aortic remodeling (false lumen thrombosis and complete reapposition of the intimal flap) was achieved in 45/55 patients (81.8%), and false lumen thrombosis in the thoracic aorta was achieved in 52/55 patients (94.5%). At 1 year, with a computed tomographic (CT) scan available for 98.2% (54/55) of patients, we observed a significant decrease in the maximal thoracic aortic diameter and a significant increase in the aortic diameter at the bare-stent level compared with the preoperative CT scan. Severe aortic angulation (p=0.024) was a risk factor for incomplete aortic remodeling and significantly increased the aortic diameter (p=0.032). Chronic aortic dissection was associated with an increased risk of incomplete aortic remodeling (p=0.002). CONCLUSIONS: STABILISE for complicated aortic dissection results in false lumen thrombosis, complete reapposition of the intimal flap, and a decrease in the maximum aortic diameter in most cases. Incomplete reapposition of the intimal flap, which is more frequent in cases of chronic aortic dissection and severe aortic angulation, is a risk factor for a significant increase in the aortic diameter at the bare-stent level, and this risk justifies close follow-up and better patient selection. CLINICAL IMPACT: STABILISE technique for complicated aortic dissection results in false lumen thrombosis, complete aortic remodeling and a decrease in the maximum aortic diameter in most cases. At the bare-stent level, incomplete reapposition of the intimal flap, more frequent in chronic aortic dissection and severe aortic angulation, is a risk factor for an increased aortic diameter. This finding justifies close follow-up and better patient selection; thus, the STABILISE technique should be used with care in chronic aortic dissection and severe aortic angulation.

Self-reported functional assessment after treatment for prostate cancer: 5-year results of the prospective cohort VICAN.

Objective: We aimed to assess the long-term association of therapeutic strategies with urinary, sexual function and health-related quality of life (HR-QoL) for 5-year prostate cancer (PC) survivors. Materials & methods: The VICAN survey consisted of self-reported data prospectively collected, including living conditions, treatment side effects and quality of life (QoL) of cancer survivors. Results: Among the 434 PC survivors, 52.8% reported urinary incontinence (UI) and 55.8% reported erectile dysfunction (ED). Patients treated with radical prostatectomy with salvage radiotherapy reported significantly more UI (p = 0.014) and more ED (p = 0.012) compared with other strategies. UI was significantly associated with physical and mental health-related QoL (p = 0.045 and p = 0.049, respectively). Conclusion: Self-assessed functional outcomes 5 years after PC diagnosis remain poor and could have an impact on health-related QoL.

Patients treated for prostate cancer may have long-term consequences due to the treatment they receive ­ in particular urinary incontinence (UI) and erectile dysfunction (ED). We analyzed self-reported data from 434 patients diagnosed with prostate cancer 5 years earlier, focusing especially on treatment side effects and the impact on patient quality of life. Of these patients, 52.8% reported UI and 55.8% reported ED. Patients treated with surgery plus radiotherapy reported significantly more UI and more ED compared with other treatment strategies. We have also shown that UI has an impact on physical and mental quality of life of these patients. In conclusion, functional recovery 5 years after prostate cancer diagnosis remains poor and requires implementation of new, long-term management strategies for cancer survivors.

Cannabidiol use and perceptions in France: a national survey.

BACKGROUND: Cannabidiol (CBD), a safe, non-intoxicating cannabis component, is growing in popularity in Europe and worldwide. However, CBD EU regulation is blurry, and consequent labelling and product quality issues may have implications for public health. There is therefore a need to assess the prevalence and perceived harmfulness of CBD use in EU countries, as well as to characterise CBD users. We aimed to do so in the French population. METHODS: In December 2021, an online survey was conducted in a sample respecting the French adult population structure for key demographic variables. Sociodemographic, behavioural and CBD perception data were collected. Three separate regressions were performed to identify correlates of i) having heard of CBD, ii) using CBD, iii) perceived harmfulness of CBD. A hierarchical classification was also performed to identify profiles of CBD users. RESULTS: The study sample comprised 1969 adults, of whom 69.2% had heard of CBD and 10.1% used it. Less than half (46.8%) of the former considered it harmful. Having heard of CBD was associated with younger age, being born in France, tobacco use, and cannabis use. CBD use was associated with younger age, tobacco use, cannabis use, poor self-reported general health status, and positive perception of alternative medicines. Cluster analysis revealed four different CBD user profiles based on socio-demographics and behavioural characteristics. CONCLUSION: Ten percent of the adults in this French study used CBD, and several user profiles emerged. Our results indirectly advocate clearer European CBD regulations to ensure safe and high-quality products.

Multidisciplinary peer-led sexual and reproductive health education programme in France, a prospective controlled-study.

BACKGROUND: Sexual education is an international priority to promote sexual and reproductive health (SRH) and to reduce risky sexual behaviour. Experts recommend holistic and comprehensive SRH peer-led education. In 2018, the French government launched a new public peer-led health prevention programme called the "Service Sanitaire" (SeSa), consisting of health education provided by healthcare students (peer educators) to teenagers. For the first time in France, the impact of the programme was prospectively evaluated during its first year to examine whether the programme improved the SRH knowledge of healthcare students and teenagers. Risk perception and risky sexual behaviour among these populations were also evaluated. METHOD: A prospective multicentre controlled study was conducted from November 2018 to May 2019. SRH knowledge was compared before and after the SeSa programme, and the evolution of this knowledge was compared, with linear regression, between healthcare students part of the SRH SeSa programme and those who were part of another programme. The same analysis of knowledge was performed with respect to teenagers who received SRH interventions as part of the SeSa compared to teenagers who did not participate in a specific SRH education programme. Risk perception and risky behaviour were studied before and after the programme among healthcare students and teenagers. RESULTS: More than 70% of the targeted population participated in the study, with 747 healthcare students and 292 teenagers. SRH peer educators increased their knowledge score significantly more than other peer educators (a difference of 2.1 points/30 [95% CI 1.4-2.9] (p [between group] <  0.001)). Teenagers participating in the SeSa interventions also had a greater increase in their knowledge score than the other teenagers (+ 5.2/30 [95% CI 3.2-7.4] p [between group] < 0.001). There was no evidence of change in sexual risk behaviours for the healthcare student population. CONCLUSION: The "Service Sanitaire" programme significantly improved the sexual and reproductive health knowledge of peer-educator healthcare students and teenagers compared to a classic education programme. Longer and/or qualitative studies are needed to evaluate changes in sexual behaviour as well as positive impacts on sexuality.

From contact tracing to COVID-19 pass holder; the tortured journey of the French TousAntiCovid contact tracing app.

OBJECTIVES: Our study aimed to provide an updated overview of the use of the French contact tracing application, TousAntiCovid, and identify evolutions since the beginning of the pandemic. STUDY DESIGN: We conducted a survey study on a representative sample of the French adult population. METHODS: Our data were collected by the Obervatoire Régional de la Santé (ORS) using a self-administered online questionnaire. This was completed by a sample of 2,022 people stratified to match French official census statistics for gender, age, occupation, and area of housing. We conducted statistical analysis using Python (Pandas - Scipy - Statsmodels) with chi-squared and Wilcoxon rank-sum tests to control for statistical significance. RESULTS: A small majority of respondents used TousAntiCovid (55.5%), while 41.0% had never downloaded it. Only one-quarter of the respondents (23.3%) used it for contact tracing with Bluetooth, while a third (32.2%) used it only for storing their health pass. The app's use increased with education level, income, and younger age. A large majority (85%) of non-vaccinated respondents had never downloaded TousAntiCovid. CONCLUSION: Our results suggest that the role and use of France's official COVID-19 app TousAntiCovid has evolved in line with the government's strategy; while initially focusing on contact tracing, its development has led to the possibility to store test and vaccination documentation. The survey also confirmed previous results pointing to the lasting differences in socio-economic status in terms of adoption of the app. This is problematic because the long-term nature of the pandemic could require the government to keep a range of strategies open, including contact tracing. Public discussion of the current and future roles of the French contact tracing app is therefore needed.

Progression of adenomyosis magnetic resonance imaging features under ulipristal acetate for symptomatic fibroids.

RESEARCH QUESTION: What is the evolution of adenomyosis on magnetic resonance imaging (MRI) after a 3-month treatment course of daily 5 mg doses of ulipristal acetate (UPA) for symptomatic fibroids? DESIGN: A monocentric prospective pilot study on patients who underwent a 3-month treatment course of UPA for symptomatic fibroids between January 2014 and December 2017. Patients underwent pelvic MRI shortly before (pre-MRI) and after treatment (post-MRI). The diagnosis of adenomyosis on MRI was defined by the observation of intramyometrial cysts and/or haemorrhagic foci within these cystic cavities and/or a thickening of the junctional zone >12 mm. The progression of adenomyosis was defined by the presence of at least one of the aforementioned criteria of adenomyosis on the pre-MRI and by at least one of the following on the post-MRI: (i) increased thickness of the junctional zone ≥20% and/or (ii) increased number of intramyometrial cysts. The appearance of adenomyosis was defined by the absence of the aforementioned criteria of adenomyosis on the pre-MRI and the presence of at least one of these criteria on the post-MRI. RESULTS: Seventy-two patients were included. The MRI features of adenomyosis progressed for 12 of 15 patients (80.0%) for whom adenomyosis was identified on the pre-MRI. An appearance of adenomyosis was identified after treatment for 15 of 57 patients (26.3%) for whom adenomyosis was not identified on the pre-MRI. CONCLUSIONS: A 3-month treatment course of daily 5 mg doses of UPA could provoke a short-term progression or an emergence of typical adenomyosis intramyometrial cysts on MRI examinations.

Unsupervised clustering analysis of data from an online community to identify lupus patient profiles with regards to treatment preferences.

OBJECTIVE: Lupus is a chronic complex autoimmune disease. Non-adherence to treatment can affect patient outcomes. Considering patients' preferences into medical decisions may increase acceptance to their medication. The PREFERLUP study used unsupervised clustering analysis to identify profiles of patients with similar treatment preferences in an online community of French lupus patients. METHODS: An online survey was conducted in adult lupus patients from the Carenity community between August 2018 and April 2019. Multiple Correspondence Analysis (MCA) was used with three unsupervised clustering methods (hierarchical, kmeans and partitioning around medoids). Several indicators (measure of connectivity, Dunn index and Silhouette width) were used to select the best clustering algorithm and choose the number of clusters. RESULTS: The 268 participants were mostly female (96%), with a mean age of 44.3 years 83% fulfilled the American College of Rheumatology (ACR) self-reported diagnostic criteria for systemic lupus erythematosus. Overall, the preferred route of administration was oral (62%) and the most important feature of an ideal drug was a low risk of side-effects (32%). Hierarchical clustering identified three clusters. Cluster 1 (59%) comprised patients with few comorbidities and a poor ability to identify oncoming flares; 84% of these patients desired oral treatments with limited side-effects. Cluster 2 (13%) comprised younger patients, who had already participated in a clinical trial, were willing to use implants and valued the compatibility of treatments with pregnancy. Cluster 3 (28%) comprised patients with a longer lupus duration, poorer control of the disease and more comorbidities; these patients mainly valued implants and injections and expected a reduction of corticosteroid intake. CONCLUSIONS: Different profiles of lupus patients were identified according to their drug preferences. These clusters could help physicians tailor their therapeutic proposals to take into account individual patient preferences, which could have a positive impact on treatment acceptance and then adherence. The study highlights the value of data acquired directly from patient communities.

Acute kidney injury in patients treated with anti-programmed death receptor-1 for advanced melanoma: a real-life study in a single-centre cohort.

BACKGROUND: Immune checkpoints inhibitors have transformed the prognosis of advanced melanoma but are associated with immune-related adverse events (irAEs). We evaluated the incidence, risk factors and causes of acute kidney injury (AKI) in a monocentric real-life cohort of patients treated with anti-programmed death receptor-1 (anti-PD1) antibodies for advanced melanoma. METHODS: Retrospective collection of medical charts and comprehensive analysis of lab results from patients treated with nivolumab or pembrolizumab for advanced melanoma between 2014 and 2018 was carried out. AKI was defined by Kidney Disease Improving Global Outcomes criteria, and causes were determined by chart review. Overall survival, survival without AKI and impact of AKI on survival were analysed. Risk factors for death and for AKI were identified. RESULTS: Two hundred and thirty-nine patients were included. Forty-one (17%) had at least one episode of AKI. Independent risk factors for AKI were treatment with renin-angiotensin-aldosterone system inhibitors (RAASi), pre-existing chronic kidney disease (CKD) and cumulated doses of anti-PD1. The main cause of AKI was prerenal, and only eight patients (3.3%) developed acute interstitial nephritis; 8% of patients developed CKD. The median overall survival was 13.4 months and was not affected by AKI. In multivariate analysis, the overall mortality was lower in overweight and obese patients and higher in patients treated with proton-pump inhibitors (PPI) or corticosteroids. CONCLUSIONS: AKI is common in patients treated with anti-PD1 for advanced melanoma but is mostly prerenal and favoured by the use of RAASi; renal irAE is rare. PPI and corticosteroids were associated with poor survival in this population, while overweight/obesity was protective.

Percutaneous lung and liver CT-guided ablation on swine model using microwave ablation to determine ablation size for clinical practice.

PURPOSE: Microwave ablation (MWA) provides an effective treatment of lung and liver tumors but suffers from a lack of reproducibility of ablation size among currently available technologies. In-vitro evaluations are far removed from clinical practices because of uninfused tissue. This study is in-vivo preclinical testing of a new MWA system on swine lungs and liver. MATERIALS AND METHODS: All ablations were performed under CT guidance and multiple algorithms were tested with a power of 50, 75, and 100 W for durations of 3, 5, 8, 10, and 15 min. A 3 D-evaluation of the ablation zone was carried out using enhanced-CT. The sphericity index, coefficients of variation, and energy efficiency (which corresponds to the volume yield according to the power supplied) were calculated. RESULTS: Fifty liver and 48 lung ablations were performed in 17 swine. The sphericity index varies from 0.50 to 0.80 for liver ablations and from 0.40 to 0.69 for lung ablations. The coefficient of variation was below 15% for 4/5 and 4/8 protocols for lung and liver ablations, respectively. The energy efficiency seems to decrease with the duration of the ablation from 0.60 × 10-3 cm3/J (75 W, 3 min) to 0.26 × 10-3 cm3/J (100 W, 15 min) in the liver and from 0.57 × 10-3 cm3/J (50 W, 10 min) to 0.42 × 10-3 cm3/J (100 W, 12 min) in the lungs. CONCLUSION: A shorter treatment time provides the best energy efficiency, and the best reproducibility is obtained for a 10 min treatment duration. The system tested provides an interesting reproducibility in both lung and liver measurements. Our results may help interventional radiologists in the optimal selection of treatment parameters.

Cross-cultural adaptation into French and validation of the SCAR-Q questionnaire.

PURPOSE: Most questionnaires designed to evaluate patient-reported outcomes regarding scarring are available in English. The objective was to generate a validated French version of the SCAR-Q questionnaire. METHODS: The SCAR-Q questionnaire (including Appearance, Symptom and Psychological impact scales) was translated into French using a translation-back-translation process in accordance with international guidelines (ISPOR and WHO). For validation, two hundred patients consulting in our tertiary center completed the questionnaire. We tested scale reliability (Cronbach's α), floor/ceiling effects and item redundancy (inter-item correlations). Structural validity was tested using confirmatory factor analysis (CFA) with the robust weighted least squares (WLSMV) estimator and Delta parameterization. Model fit was examined using the root mean square error of approximation (RMSEA), the comparative fit index (CFI) and the Tucker-Lewis index (TLI). Correlations between scales and scale repeatability were tested (Spearman coefficient, Intra-class-coefficient). RESULTS: Four steps were required to obtain a translation consistent with the original version. Two hundred patients completed the questionnaire for validation. Internal consistency analysis found Cronbach's alphas > 0.7 for all scales (0.90 < α < 0.97). No floor or ceiling effect was found for all items (max = 85%). A ceiling effect was observed for all scales. Appearance and psychosocial impact scale items showed redundancy, with many inter-item correlations above 0.7. The CFA of the original structure displayed a reasonable fit, with RMSEA = 0.065, CFI = 0.974 and TLI = 0.972. Scales were positively correlated (0.45 < ρ < 0.65; p < 0.001). Test-retest intra-class correlation coefficients ranged from 0.94 to 0.99 for all scales. CONCLUSION: A French version of the SCAR-Q questionnaire is validated, ready for use.

Kidney biopsy in very elderly patients: indications, therapeutic impact and complications.

BACKGROUND: Few data is available on the risk/benefit balance of native kidney biopsy (KB) in very elderly patients. METHODS: Multicenter retrospective cohort study in the Aix-Marseille area: the results of KB and medical charts of all patients over 85 years biopsied between January 2010 and December 2018 were reviewed. RESULTS: 104 patients were included. Median age was 87 years. Indications for KB were: acute kidney injury (AKI) in 69.2% of patients, nephrotic syndrome (NS) with AKI in 13.5%, NS without AKI in 12.5%, and proteinuria in 4.8%. Median serum creatinine was 262 µmol/L, 21% of patients required dialysis at the time of KB. Significant bleeding occurred in 7 (6.7%) patients, requiring blood cell transfusion in 4 (3.8%), and radiological embolization in 1 (1%). The most frequent pathological diagnoses were: non-diabetic glomerular diseases (29.8%, including pauci-immune crescentic glomerulonephritis in 9.6%), hypertensive nephropathy (27.9%), acute interstitial nephritis (16.3%), renal involvement of hematological malignancy (8.7%), and acute tubular necrosis (6.7%). After KB, 51 (49%) patients received a specific treatment: corticosteroids (41.3%), cyclophosphamide (6.7%), rituximab (6.7%), bortezomib (3.8%), other chemotherapies (3.8%). Median overall survival was 31 months. CONCLUSIONS: KB can reveal a diagnosis with therapeutic impact even in very elderly patients. Severe bleeding was not frequent in this cohort, but KB may have not been performed in more vulnerable patients.

Impact of a health literacy intervention combining general practitioner training and a consumer facing intervention to improve colorectal cancer screening in underserved areas: protocol for a multicentric cluster randomized controlled trial.

BACKGROUND: Colorectal cancer (CRC) is a leading cause of cancer burden worldwide. In France, it is the second most common cause of cancer death after lung cancer. Systematic uptake of CRC screening can improve survival rates. However, people with limited health literacy (HL) and lower socioeconomic position rarely participate. Our aim is to assess the impact of an intervention combining HL and CRC screening training for general practitioners (GPs) with a pictorial brochure and video targeting eligible patients, to increase CRC screening and other secondary outcomes, after 1 year, in several underserved geographic areas in France. METHODS: We will use a two-arm multicentric randomized controlled cluster trial with 32 GPs primarily serving underserved populations across four regions in France with 1024 patients recruited. GPs practicing in underserved areas (identified using the European Deprivation Index) will be block-randomized to: 1) a combined intervention (HL and CRC training + brochure and video for eligible patients), or 2) usual care. Patients will be included if they are between 50 and 74 years old, eligible for CRC screening, and present to recruited GPs. The primary outcome is CRC screening uptake after 1 year. Secondary outcomes include increasing knowledge and patient activation. After trial recruitment, we will conduct semi-structured interviews with up to 24 GPs (up to 8 in each region) and up to 48 patients (6 to 12 per region) based on data saturation. We will explore strategies that promote the intervention's sustained use and rapid implementation using Normalization Process Theory. We will follow a community-based participatory research approach throughout the trial. For the analyses, we will adopt a regression framework for all quantitative data. We will also use exploratory mediation analyses. We will analyze all qualitative data using a framework analysis guided by Normalization Process Theory. DISCUSSION: Limited HL and its impact on the general population is a growing public health and policy challenge worldwide. It has received limited attention in France. A combined HL intervention could reduce disparities in CRC screening, increase screening rates among the most vulnerable populations, and increase knowledge and activation (beneficial in the context of repeated screening). TRIAL REGISTRATION: Registry: ClinicalTrials.gov. TRIAL REGISTRATION NUMBER: 2020-A01687-32 . Date of registration: 17th November 2020.

Is the Natural Anatomical Evolution of Type B Intramural Hematomas Reliable to Identify the Patients at Risk of Aneurysmal Progression?

BACKGROUND: The natural history of type B intramural hematomas is little-known. Aneurysmal progression or an aortic dissection occurs in 15 to 20% of the cases. The study of the natural anatomical evolution could help identify the patients at risk of unfavorable evolution. METHODS: All the patients monitored for a type B intramural hematoma between 2009 and 2018 were included in this monocentric retrospective study. Computed tomography angiography centerline measurement of diameters was obtained in various points of aortic segmentation on day (D) 0 and at one month (M1). Aortic volumes (lumen, intramural hematoma, and total volume) were calculated. The circulating volume was calculated using the volume rendering method. The volume of the intramural hematoma was measured using a manual section-by-section segmentation tool, and the total volume was obtained by summing up the two preceding volumes. Two groups of patients were compared: group 1 (favorable anatomical evolution) and group 2 (unfavorable anatomical evolution). RESULTS: Between January 2008 and August 2018, 25 patients were managed for a type B intramural hematoma in our center. After an average follow-up of 15.5 months (1-52), 13 patients (52%) presented a favorable evolution and 12 (48%) an unfavorable evolution. At M1, a significant increase of the luminal diameters (37 mm vs. 32 mm; P < 0.01) and a significant reduction in the longitudinal extension (19 mm vs. 26 mm; P < 0.01) were observed. The maximum aortic diameter evolved significantly between D0 and M1 in the unfavorable evolution group (49 mm vs. 44 mm, respectively; P = 0.038). Such a difference was not found in the favorable evolution group (37.4 vs. 37.1, respectively; P = 0.552). An overall significant reduction in the total aortic volume (166 cm3 vs. 219 cm3; P < 0.01), the circulating volume (124 cm3 vs. 145 cm3; P = 0,026), and the volume of the hematoma (42 cm3 vs. 39 cm3; P < 0.01) was observed. The circulating volume decreased significantly between D0 and M1 in the favorable evolution group (110 cm3 vs. 135 cm3; P = 0.05), whereas no difference was noted in the unfavorable group (142 cm3 vs, 157 cm3; P = 0.24). CONCLUSIONS: The progression of the maximum aortic diameter and of the circulating volume after one month of follow-up could be predictive factors of the poor long-term evolution of type B intramural hematomas.