COLODETECT 1: comparative evaluation of endocuff with computer-aided detection versus computer-aided detection alone versus standard colonoscopy for enhancing adenoma detection rates during screening colonoscopy-a pilot study.

Background: Independent use of artificial intelligence with computer-aided detection (CADe) and Endocuff Vision (ECV) has demonstrated enhanced adenoma detection rates (ADRs). Objective: Our pilot study aimed to define the necessary participant number for future randomized controlled trials (RCTs) by comparing the ADR of combined CADe + ECV against CADe alone and standard colonoscopy. Design: This single-center pilot study retrospectively analyzed a prospectively maintained database, where patients underwent screening colonoscopies sequentially by standard method, CADe alone, and then CADe + ECV. Method: The allocation of the technique depended on the study period. Patients were randomly selected from the cohort to form three groups of 30 patients, with stratification based on factors influencing the ADR. The primary endpoint was the ADR. Results: From April to June 2021, 244 patients underwent screening colonoscopy. 198 were eligible, and after randomization, 90 patients were included across three groups (colonoscopy n = 30, CADe n = 30, CADe + ECV = 30). The ADR was higher in the CADe + ECV group compared to the CADe and colonoscopy groups: 60% versus 40%, and 30%, respectively (p = 0.03). The number of polyps ⩽3 mm detected was greater in the CADe + ECV group (n = 23) versus CADe (n = 7) and colonoscopy (n = 12) groups, respectively (p = 0.03). CADe + ECV identified more polyps in the cecum/right colon (n = 26) compared to CADe (n = 18) and colonoscopy (n = 12) groups (p = 0.04), and in the left colon/sigmoid (n = 14) compared to CADe (n = 5) and colonoscopy (n = 2) (p = 0.02). Conclusion: These findings underscore the synergic potential of combining CADe with ECV to enhance ADR and enable us to perform sample size calculations for future RCTs. Registration: Clinical Trials number: NCT05080088. Registration 06/06/2021.

Improving polyp detection during colonoscopy: comparing three techniques Colorectal cancer is a leading cause of cancer-related deaths, and early detection of adenomas (precancerous polyps) during colonoscopy is crucial in preventing this disease. Our study aimed to evaluate the effectiveness of three different colonoscopy techniques in detecting adenomas: standard colonoscopy, colonoscopy with computer-aided detection (CADe), and colonoscopy combining CADe with Endocuff Vision (ECV). We conducted a pilot study with 90 patients, divided into three groups of 30 each. One group underwent standard colonoscopy, another had colonoscopy with CADe, and the third group experienced colonoscopy with both CADe and ECV. Our results showed that the combined CADe + ECV technique detected the highest number of adenomas, significantly outperforming both standard colonoscopy and CADe alone. Specifically, 60% of patients in the CADe + ECV group had adenomas detected, compared to 40% in the CADe group and 30% in the standard colonoscopy group. This study highlights the potential benefits of using advanced technologies like CADe and ECV together to improve adenoma detection rates during colonoscopy, ultimately aiding in better prevention of colorectal cancer. Future larger-scale studies are needed to confirm these findings and refine the use of these technologies in clinical practice.

Development and psychometric properties of the Balance in Daily Life (BDL) scale in a population of frail older people.

BACKGROUND: Balance disorders in older people cause falls, which can have serious functional and economic consequences. No existing scale relates fall risk to daily life situations. This study describes the development, psychometric properties and construct validity of the Balance in Daily Life (BDL) scale, comprising seven routine tasks including answering a phone, carrying a heavy bag, and sitting down and getting up from a chair. METHODS: Frail patients aged 65 years or more were prospectively recruited from the geriatric rehabilitation department of a French university hospital. Inclusion criteria included autonomous walking over 20 m and modified Short Emergency Geriatric Assessment score 8-11. Patients with motor skills disorders and comprehension or major memory difficulties were excluded. Patients were assessed on Day 3 and Day 30 with the Balance in Daily Life scale, Timed Up and Go, one-leg stance time, sternal nudge and walking-while-talking tests. The scale was assessed for acceptability, quality, unidimensionality, internal consistency, reliability, temporal stability, responsiveness and construct validity. RESULTS: 140 patients (83 ± 6 years) were recruited, of whom 139 were assessed at Day 0 and 133 at Day 30. Acceptability was satisfactory (134/139 patients completed the test), quality assessment showed a slight floor effect (6 % of patients with minimal score) and evaluation of item redundancy found no strong correlation (Spearman <0.7). Unidimensionality was verified (Loevinger H coefficient > 0.5 for all items except item 6 = 0.4728). Internal consistency was good (Cronbach alpha = 0.86). Reliability and temporal stability were excellent (ICC = 0.97 and ICC = 0.92). Responsiveness was verified by significant score change p < 0.0001 between Day 0 and Day 30 (decreased by 1 [0; 2] point), in line with other score changes. Construct validity revealed that the Balance in Daily Life scale was convergent with results of the timed up-and-go and one-leg stance time (p < 0.0001 for both) and tended to be higher for participants who had not fallen in the previous 6 months (p = 0.0528). The new questionnaire was divergent to sternal nudge tests (p = 0.0002) and not related to the walking-while-talking test (p = 0.5969). CONCLUSION: The Balance in Daily Life scale has good psychometric properties for this population. Its simplicity and innovative nature mean that it can be applied in institutions while being easily modifiable to domestic settings. Study registration on clinicaltrials.gov: NCT0334382.

Regulatory T and B cells in pediatric Henoch-Schönlein purpura: friends or foes?

BACKGROUND AND OBJECTIVES: Henoch-Schönlein purpura (HSP) is the most common immunoglobulin A-mediated systemic vasculitis in childhood. We studied immune dysregulation in HSP by analyzing regulatory T (Treg), T helper 3 (Th3), and regulatory B cell (Breg) subpopulations that might intervene in immune activation, IgA production, and HSP clinical manifestations. METHODS: This prospective study included 3 groups of children: 30 HSP on acute phase, 30 HSP on remission, and 40 healthy controls (HCs) matched on age. Treg, Breg, and Th3 were analyzed by flow cytometry. Serum immunoglobulin and cytokine levels were quantified by ELISA and Luminex. RESULTS: Treg frequencies were higher in acute HSP than in remitting HSP and HCs (6.53% [4.24; 9.21] vs. 4.33% [3.6; 5.66], p = 0.002, and vs. 4.45% [3.01; 6.6], p = 0.003, respectively). Activated Th3 cells (FoxP3 + Th3 cells) tend to be more abundant in HSP than in HCs (78.43% [50.62; 80.84] vs. 43.30% [40.20; 49.32], p = 0.135). Serum IgA, IL-17, and latency-associated peptide (a marker of the anti-inflammatory cytokine TGF-beta production) were significantly and inflammatory cytokines TNF-alpha, IL-1-beta, and IL-6 were non-significantly higher in HSP than HCs. Bregs were identical between the groups, but, in patients with renal impairment, Breg percentage was lower compared to those without. Treg removal in PBMC culture resulted in an increase in IgA production in HSP proving a negative regulatory role of Tregs on IgA production. CONCLUSIONS: In pediatric HSP, immune activation persists in spite of an increase in Th3 and Tregs. Th3 could be involved in IgA hyperproduction, inefficiently downregulated by Tregs. Lack of Bregs appears linked to renal impairment.

Teleconsultation compared with face-to-face consultation in the context of pre-anesthesia evaluation: TELANESTH, a randomized controlled single-blind non-inferiority study.

STUDY OBJECTIVE: During the COVID crisis, pre-anesthesia teleconsultations were widely used leading to savings in time and money. However, the non-inferiority of this system has not yet been evaluated. DESIGN: Prospective, randomized, controlled, single-blind non-inferiority study. SETTING: University hospital. PATIENTS: Patients scheduled for surgery requiring a single pre-anesthesia consultation (PAC). INTERVENTION: Pre-anesthesia teleconsultation (PATC) from patient's home. MEASUREMENTS: Primary outcome: concordance between the pre-anesthesia visit (PAV), performed on the day of surgery, and PAC or PATC on: Secondary outcomes: cancellation rate, immediate perioperative complications, patient satisfaction, organization, and economic and ecological costs. MAIN RESULTS: Out of 172 patients included, 149 were analyzed. PATC was no less effective than PAC in terms of the primary outcome or each of its components: the difference between groups was: - 0.044[90% CI: -0.135; 0.047] (p = 0.0002). There was no difference in cancellation rates (PAC 1.99% vs. PATC 1.27%, p = 0.6) or in immediate perioperative complications (none). Satisfaction was 9.48 (±1.45) in the PAC group and 8.96 (±1.68) in the PATC group (p = 0.0006). In the PATC group, the mean savings per patient were 30 km (± 29), 36 min (± 27), and 18 (± 18) euros, respectively. CONCLUSIONS: According to our criteria, PATC was not inferior to PAC for preoperative patient evaluation and may be an interesting economical, ecological alternative.

Design and rationale of a single-arm phase II study of neoadjuvant Durvalumab and Gemcitabine associated with Cisplatin or Carboplatin for upper urinary tract urothelial cancer: the iNDUCT trial (NCT04617756).

BACKGROUND: Upper urinary tract urothelial carcinoma (UTUC) is often locally advanced at initial diagnosis and is associated with high recurrence and mortality rates after radical nephroureterectomy (RNU). Adjuvant platinum-based chemotherapy has shown a recurrence-free survival benefit in a randomised phase III trial, while neoadjuvant treatment seems promising in retrospective series. On the contrary, little is known about the role of perioperative immunotherapy and its combination with chemotherapy for UTUC patients, although initial positive results have been published for muscle-invasive bladder cancer. STUDY DESIGN AND ENDPOINTS: Against this backdrop, we are running a multi-centre single-arm phase 2 trial of neoadjuvant Durvalumab, a monoclonal antibody targeting programmed cell death ligand 1, combined with Gemcitabine and Cisplatin or Carboplatin for high-risk UTUC patients. The primary outcome is pathological complete response rate at RNU. Secondary endpoints include the partial pathological response rate, safety, as well as disease-free and overall survival. A biomarker analysis is also planned. PATIENTS AND INTERVENTIONS: Included patients must have a good performance status and harbour a non-metastatic UTUC, considered at high risk of progression, defined as either biopsy-proven high-grade disease or invasive features at imaging with or, more recently, without high-grade cytology at the multidisciplinary team discretion, as specified in the latest amendment. Enrolled patients receive 3 cycles of neoadjuvant immuno-chemotherapy before RNU, and the standard of care thereafter. The trial is registered as NCT04617756 and is supervised by an independent data monitoring committee.

[Photobiomodulation and vulvovaginal disorders after anticancer treatments]. / Photobiomodulation et troubles vulvovaginaux après traitements anticancéreux.

Anticancer treatments induce vulvovaginal complications that alter the quality of life and sexuality of patients. New technologies, such as photobiomodulation, could address this problem, for which few effective therapeutic solutions exist. The objective of this study was to describe the characteristics of patients seeking treatment and to observe the effects of photobiomodulation. This is a prospective cohort of patients treated for cancer, in failure of first-line medical treatment, managed at the University Hospital of Nîmes. The history, symptoms and impact of the disorders on their quality of life were collected. At follow-up, improvement was assessed using the PGI-I and FSFI questionnaires. Twenty-eight patients were treated. They were all menopausal, half of them after anticancer treatments [chemotherapy (78%), radiotherapy (36%), hormone therapy (36%)]. The main symptom reported was vaginal dryness (72%). Seventy-one percent of patients (n=20) felt that their daily life was affected≥8/10. All patients had sexual dysfunction. Twenty-two patients received at least 6 sessions of photobiomodulation. Seventy-two percent (n=18) of patients felt better or much better after treatment (PGI-I≤2). The median improvement estimated by the patients was 65% (Q1=50%; Q3=72.5%). There was also a significant clinical improvement. No serious adverse events were reported. Due to the small number of patients in a heterogeneous population with no control group, we cannot extrapolate our results. However, the objective was to assess the status of these pathologies and the contribution of photobiomodulation in patients who have failed first-line treatment; and these results are encouraging.

Comparison of the Discovery A and Stratos DR densitometers for assessing whole-body and regional bone mineral density and body composition.

PURPOSE: The agreement between the Stratos DR and Discovery A densitometers was assessed for measurements of whole-body (WB) and regional fat mass (FM), fat-free soft tissue (FFST) and bone mineral density (BMD). Moreover, the precision of the Stratos DR was also evaluated. METHODS: Fifty participants (35 women, 70%) were measured consecutively, once on the Discovery A and once on the Stratos DR. In a subgroup of participants (n = 29), two successive measurements with the Stratos DR were also performed. RESULTS: FM, FFST and BMD measured with the two devices were highly correlated, with a coefficient of correlation ranging from 0.80 to 0.99. Bland-Altman analyses indicated significant bias between the two devices for all measurements. Thus, compared to the Discovery A, the Stratos DR underestimated WB BMD and WB and regional FM and FFST, with the exception of trunk FM and visceral adipose tissue (VAT), which were overestimated. Precision error for the Stratos DR, when expressed as root mean square-coefficient of variation (RMS-CV%) for FM, was 1.4% for WB, 3.0% for the gynoid and android regions, and 15.9% for VAT. The RMS-CV% for FFST was 1.0% for WB. The root mean square of standard deviation for WB BMD was 0.018 g/cm², corresponding to a 1.4% CV. The least significant change was 0.050 g/cm² (SD), and 4.0% was considered to be a significant biological change. CONCLUSIONS: Differences between the Stratos DR and Discovery A measurements are significant and require the use of translational cross-calibration equations. For most of the BMD and body composition parameters, our results demonstrated good Stratos DR precision.

Agreement of respiratory viruses' detection between nasopharyngeal swab and bronchoalveolar lavage in adults admitted for pneumonia: a retrospective study.

OBJECTIVES: The COVID-19 pandemic has highlighted the high diagnostic accuracy of the nasopharyngeal swab (including in intensive care unit (ICU) patients). This study aimed to compare nasopharyngeal swab and bronchoalveolar lavage (BAL) results for non-SARS-CoV-2 viruses in patients with suspected pneumonia. METHODS: A retrospective analysis was performed in one French academic hospital on consecutive adults from 2012 to 2018 and tested nasopharyngeal swab and BAL within 24 hours by using multiplex PCR. The agreement in pathogen detection between nasopharyngeal swab and BAL was evaluated. RESULTS: Patients were primarily men (n = 178/276, 64.5%), with a median age of 60 years (IQR: 51-68 years). Of the 276 patients, 169 (61%) were admitted to the ICU for acute respiratory distress. We detected at least one respiratory virus in 34.4% of the nasopharyngeal swabs (n = 95/276) and 29.0% of BAL (n = 80/276). Two or more viruses were detected in 2.5% of the nasopharyngeal swabs (n = 7/276) and 2.2% of BAL (n = 6/276). Rhinovirus/enteroviruses were the most frequently detected viral group in 10.2% (n = 29/285) of the nasopharyngeal swabs and 9.5% (n = 27/285) of BAL, followed by influenza A, detected in 5.6% (n = 16/285) of the nasopharyngeal swabs and 4.9% (n = 14/285) of BAL. Overall agreement was 83.7% (n = 231/276 (95% CI [78.7%, 87.7%])) (i.e. same pathogen or pathogen combination was identified in the nasopharyngeal swab and BAL for 231 patients). Rhinovirus/enterovirus (n = 29/231) and respiratory syncytial virus (n = 13/231) had the lowest agreement of 62.1% (n = 18/29 (95% CI [42.4%-78.7%])) and 61.5% (n = 8/13 (95% CI [32.3%-84.9%])), respectively). CONCLUSIONS: There was a good agreement between nasopharyngeal swabs and BAL in detecting respiratory viruses among adult patients with suspected pneumonia. However, these data still encourage BAL in the case of a negative nasopharyngeal swab.

Hospitalization cost of Pressurized Intraperitoneal Aerosol chemotherapy (PIPAC).

INTRODUCTION: Pressurized Intraperitoneal Aerosol chemotherapy (PIPAC) is a new surgical technique for the treatment of unresectable peritoneal carcinomatosis. Very little data is available on the costs of this treatment in France as there is currently no code for PIPAC in the French Common Classification of Medical Acts (CCAM). Our objective was to estimate the mean cost of hospitalization for PIPAC in two French public teaching hospitals. METHODS: The mean cost of hospitalization was estimated from the mean fixed-rate remuneration paid to the hospital and the mean additional costs of treatment paid by the hospital. At discharge a patient's hospitalization is classified into a diagnosis related group, which determines the fixed-rate remuneration paid to the hospital (obtained from the national hospitals database - PMSI). Costs of medical devices and drug treatments specific to PIPAC, not covered by the fixed-rate remuneration, were obtained from the hospital pharmacies. RESULTS: Between July 2016 and November 2021, 205 PIPAC procedures were performed on 79 patients (mean procedures per patient = 2.6). Mean operating room occupancy was 165 min. The mean fixed-rate remuneration received by the hospitals per PIPAC hospitalization was €4031. The actual mean cost per hospitalization was €6562 for a mean length-of-stay of 3.3 days. Thus, each PIPAC hospitalization cost the hospital €2531 on average. CONCLUSION: The current reimbursement of PIPAC treatment by the national health system is insufficient and represents only 61% of the real cost. The creation of a new fixed-rate remuneration for PIPAC taking into account this cost differential is necessary.

Impact of Daily Bedside Echocardiographic Assessment on Readmissions in Acute Heart Failure: A Randomized Clinical Trial.

Acute heart failure (AHF) management is challenging, with high morbidity and readmission rates. There is little evidence of the benefit of HF monitoring during hospitalization. The aim of the study was to assess whether daily bedside echocardiographic monitoring (JetEcho) improved outcomes in AHF. In this prospective, open, two parallel-arm study (clinicaltrials.gov: NCT02892227), participants from two university hospitals were randomized to either standard of care (SC) or daily treatment adjustment including diuretics guided by JetEcho evaluating left ventricular filling pressure and volemia. The primary outcome was 30-day readmission rate. Key secondary outcomes were six-month cumulative incidence death, worsening HF during hospitalization and increasing of myocardial and renal biomarkers. From 250 included patients, 115 were finally analyzed in JetEcho group and 112 in SC group. Twenty-two (19%) patients were readmitted within 30 days in JetEcho group and 17 (15%) in SC group (relative risk [RR] 1.26; 95% confidence interval [CI], 0.70−2.24; p = 0.4). Worsening HF occurred in 17 (14%) patients in the JetEcho group and 24 (20%) in the SC group (RR 0.7; 95% [CI] 0.39 to 1.2; p = 0.2). No significant difference was found between the two groups concerning natriuretic peptides and renal function (p > 0.05 for all). The cumulative incidence rate of death from any cause at six months from discharge was 8.7% in the JetEcho group and 11.6% in the SC group (HR 0.63, 95% [CI] 0.3−1.4, p = 0.3). In AHF patients, a systematic daily bedside echocardiographic monitoring did not reduce 30-day readmission rate for HF and short-term clinical outcomes.

Personalized dietary advices provided by a dietitian increase calcium intake in outpatients with multiple sclerosis-Results from a randomized, controlled, single-blind trial.

Background and aims: Multiple sclerosis (MS) is associated with osteoporosis, possibly due to neurological disability and decreased calcium intake. The objective of this study was to evaluate the efficacy of a personalized nutritional advice program by a dietitian compared to the delivery of a standard advice form to optimize dietary calcium intake in outpatients with MS. Methods: We performed a randomized, controlled, parallel trial comparing the efficacy of a personalized dietary advice (PDA) program to standard advice form (SAF) to increase daily calcium intake in MS patients. The study population was composed by patients with relapsing-remitting MS aged 18-69 years old. PDA program consisted in dietary advice delivered by a dietitian at baseline, 1 month, and 3 months. Calcium and nutrient intake in patients from both groups was evaluated at baseline and 6 months using a dietary survey. Results: Of the 194 patients screened for inclusion, 182 patients were included (79% female, median age of 42 years, and median EDSS of 2.0), and randomized to SAF (n = 92) or PDA (n = 90). At 6 months, median calcium intake increased by 241 mg/day in the PDA group and decreased by 120 mg/day in the SAF group (p < 0.0001). However, the median calcium intake was 947 mg/day in the SAF group and 778 mg/day in the PDA group at baseline (p = 0.0077), potentially favoring the effect of dietary advice. Complementary analyses focusing on patients with insufficient calcium intakes at baseline revealed comparable values in both groups (p = 0.69). Of those, patients included in the PDA group obtained significantly higher calcium intakes at 6 months than patients from the SAF group (p = 0.0086) independently of EDSS, PASAT, HADS and EQ-5D scores. Conclusion: This work shows the efficacy of dietary management based on personalized advice program over 3 months to durably increase calcium consumption in MS patients with insufficient calcium intake. Clinical trial registration: clinicaltrials.gov, identifier NCT02664623.

Quality of life determinants in older patients with cancer: Results from a French prospective monocenter cohort.

OBJECTIVES: The aim of this study is to describe determinants of quality of life (QOL) quoted by vulnerable older patients with cancer and compare them with domains included in cancer-specific QOL questionnaires. MATERIAL AND METHODS: This prospective, monocenter, observational study was performed in a French university hospital. Cancer patients Patients with cancer aged over 74 years were recruited when referred for an out-patient geriatric evaluation (n = 102). After geriatric assessment, they were invited to respond to open-ended questions, Q1: "For you, what is most important to have a good QOL?" Q2: "What could improve your QOL?" Q3: "What could worsen your QOL?" A Delphi process was conducted to categorize patient responses according to content analysis. RESULTS: The most frequently patient-reported determinants for high quality of life were maintaining close ties with family/friends or social relations, autonomy for decision and mobility without depending on others, being in good health, not suffering from pain and the absence of problems concerning relatives. Global health status, physical functioning/mobility, social functioning and worries about others were the more frequently mentioned QOL domains related to the EORTC QLQ-C30 and ELD14 questionnaires. Some determinants of QOL were not linked to pre-defined domains, some others without a 100% consensus after the Delphi process, illustrating the subjectivity of QOL analysis by a single practitioner. CONCLUSION: Patient interview with open-ended questions provides valuable supplementary information to QOL questionnaires, in order to personalize health related (cancer treatment, pain management…) and global (maintenance of autonomy and family/social relations…) assessment and intervention.

Characterisation of pragmatic postoperative PAin Trajectories over seven days and their association with CHronicity after 3 months: a prospective, pilot cohort study (PATCH study).

BACKGROUND: Reliable outcome measurement providing information both on early and late postoperative pain outcomes are still lacking. The purpose of this study was: 1) to characterise postoperative pain trajectories according to an innovative pragmatic concept: ideal pain trajectory (rapid and sustained pain relief) vs non-ideal pain trajectories (late, transient, or no pain relief); and 2) to assess the incidence of persistent post-surgical pain (PPSP) and the potential association between non-ideal pain trajectories and PPSP. METHODS: This prospective observational pilot cohort study was performed from March until June 2016. A total of 344 patients undergoing major general surgery were invited to complete a self-assessment of pain intensity using numerical rating scale (NRS; 0 = no pain to 10 = worst pain) from day 1 until day 7 after surgery, in order to establish their pain trajectory. Three months after surgery, patients were screened for PPSP. RESULTS: Rest pain score was analysed in 308 participants. Among them, 210 (68% - 95% CI: 63-73) had an "ideal" pain trajectory, while 98 (32% - 95% CI: 27-37) had "non-ideal" pain trajectories. Three months after surgery, 31% (95% CI: 26-37) reported PPSP. Multivariable analysis showed that "non-ideal" pain trajectories [OR 2.25; (95% CI: 1.26-4.01) P = 0.006] were significantly associated with PPSP. CONCLUSIONS: The present study proposes an innovative pragmatic concept of postoperative pain trajectories: ideal vs non-ideal pain trajectories, providing information both on acute postoperative pain resolution and early identification patients at risk for developing PPSP. TRIAL REGISTRATION: NCT02599233; November, 6, 2015, with clinicaltrials.gov.

Early Results of Unilateral Prostatic Artery Embolization as a Focal Therapy in Patients with Prostate Cancer under Active Surveillance: Cancer Prostate Embolisation, a Pilot Study.

PURPOSE: To evaluate the feasibility of prostatic artery embolization in patients with low-risk prostate cancer (PC) under active surveillance (AS). METHODS: This monocentric prospective pilot study, running from June 2018 to June 2019, included 10 patients with low-risk PC under AS, median age 72 years (range, 62-77 years), with a unilateral focal lesion visible on magnetic resonance (MR) imaging, with Prostate Imaging Reporting and Data System v2 score ≥3/5 confirmed by multiparametric MR imaging-targeted biopsy and Gleason score 6. The patients underwent unilateral prostatic artery embolization with 300-500 µm Embospheres in the affected prostatic lobe. The primary endpoint was technical feasibility (prostate and no off-target ischemia in the imaging). The secondary endpoints included safety, negative biopsies/MR imaging response/functional outcomes at 6 months, and oncologic efficacy at 1 year. RESULTS: Embolization was successfully achieved in all patients; prostate ischemia was confirmed on multiparametric MR imaging, and no off-target ischemia was reported. No major complications were reported. Four patients (40%) presented with both negative targeted and systematic biopsies at 6 months. No lesions were seen on the MR imaging in 30% of patients. The mean International Prostate Symptom Score and International Index of Erectile Function score were 7 and 19 and 5 and 20 at baseline and 6 months, respectively, with no significant difference. Nine patients (90%) were still under AS at 1 year. One patient (10%) had PC progression outside the target lesion and was switched over to curative radiotherapy. CONCLUSIONS: Prostatic artery embolization is feasible and appears safe for prostate cancer patients under AS, with no impact on erectile function or continence status. These results justify the pursuit of further studies.

Feasibility of remote digital monitoring using wireless Bluetooth monitors, the Smart Angel™ app and an original web platform for patients following outpatient surgery: a prospective observational pilot study.

BACKGROUND: Remote monitoring of mean arterial blood pressure (MAP), heart rate (HR) or oxygen saturation (SpO2) remains a challenge in outpatient surgery. This study evaluates a new digital technology (Smart Angel™) for remotely monitoring hemodynamic data in real time: data transmitted from the patient's home to a central server, using a dedicated web-based software package. METHODS: Adults scheduled for elective outpatient surgery were prospectively enrolled. In the first 5 postoperative days, patients completed a self-report questionnaire (pain, comfort, nausea, vomiting) and recorded SpO2, HR and MAP via two wireless Bluetooth monitors connected to a 4G tablet to transmit the data to a website, in real time, using Smart Angel™ software. Before transmission to the website, these data were also self-reported by the patient on a paper form. The primary outcome was the proportion of variables (self-monitored physiological data + questionnaire scores) correctly transmitted to the hospital via the system compared with the paper version. On Day 5, a system usability scale survey (SUS score 1-100) was also attributed. RESULTS: From May 2018 to September 2018, data were available for 29 out of 30 patients enrolled (1 patient was not discharged from hospital after surgery). The remote monitoring technology recorded 2038 data items (62%) compared with 2656 (82%) items recorded on the paper form (p = 0.001). The most common errors with the remote technology were software malfunctioning when starting the MAP monitor and malfunctioning between the tablet and the Bluetooth monitor. No serious adverse events were noted. The SUS score for the system was 85 (68-93) for 26 patients. CONCLUSION: This work evaluates the ability of a pilot system for monitoring remote physiological data using digital technology after ambulatory surgery and highlights the digital limitations of this technology. Technological improvements are required to reduce malfunctioning (4G access, transmission between apps). TRIAL REGISTRATION: ClinicalTrials.gov ( NCT03464721 ) (March 8, 2018).

[Development of a standardized guide for optimizing drug adherence information to be dispensed during a pharmaceutical counseling with a multiple myeloma patient: Final validation]. / Élaboration d'un guide standardisé d'informations d'optimisation de l'adhésion médicamenteuse à dispenser lors d'une consultation pharmaceutique au patient atteint de myélome multiple : validation finale.

An initial validation of a standardized pharmaceutical counselling guide was carried out in a previous study to improve medication adherence in patients treated for multiple myeloma with oral anticancer therapies. The main objective of this work was the final validation of this guide with 10 naive patients. The main secondary objectives were to assess for the patient the evolution of knowledge about the treatment, understanding of the purpose of the pharmaceutical counselling, adherence to the tools. Each patient completed a self-administered questionnaire: before and after the first pharmaceutical counselling. The primary endpoint was the average success rate per question after the pharmaceutical counselling (a value of ≥ 90% validated knowledge acquisition). Secondary judgement criteria were: change in average success rates per patient and question, rate of reformulation of the objective of the pharmaceutical counselling, response rate to presentation questions, readability and understanding. No average success rate per question after the pharmaceutical counselling was statistically less than 90%. The average success rates per patient before and after the pharmaceutical counselling were 78.9±13.7% vs 96.1±3.9% (P=0.01). The average success rates per question were different for 4 questions. All patients were able to reformulate the objective of the pharmaceutical counselling and validated the presentation, readability and understanding of the documents. This study led to the final validation of the pharmaceutical counselling guide.

Management of acute heart failure: Contribution of daily bedside echocardiographic assessment on therapy adjustment with impact measure on the 30-day readmission rate (JECICA).

There are currently one million heart failure (HF) patients in France and the rate is progressively increases due to population aging. Acute decompensation of HF is the leading cause of hospitalization in people over 65 years of age with a 25% re-hospitalization rate in the first month. Expenses related to the management of HF in France in 2013 amounted to more than one billion euros, of which 65% were for hospitalizations alone. The management of acute decompensation is a challenge, due to the complexity of clinical and laboratory evaluation leading to therapeutic errors, which in turn leads to longer hospitalization, high early re-hospitalization and complications. Therapeutic adjustment, especially diuretic, in the acute phase (during hospitalization) affects early re-hospitalization rates (within 30 days). These adjustments can be based on clinical estimation and laboratory parameters, but echocardiography has been shown to be superior in estimating filling pressures (FP) compared to clinical and laboratory parameters. We hypothesize that a simple daily bedside echocardiographic assessment could provide a reproducible estimation of FP with an evaluation of mitral inflow and the inferior vena cava (IVC). This could allow a more reliable estimate of the true blood volume of the patient and thus lead to a more suitable therapeutic adjustment. This in turn should lead to a decrease in early re-admission rate (primary endpoint) and potentially decrease six-month mortality and rate of complications.

Assessment of five different probes for lung ultrasound in critically ill patients: A pilot study.

INTRODUCTION: The present study was aimed at comparing the diagnosis concordance of five echo probes of lung ultrasound (LUS) with CT scans in intensive care and emergency patients with acute respiratory failure. MATERIALS: This prospective, observational, pilot study involved 10 acute patients in whom a thoracic CT scan was performed. An expert performed an LUS reference exam using five different probes: three probes with a high-quality conventional echo machine (cardiac phased-array probe, abdominal convex probe, linear probe) and two probes (cardiac and linear) with a pocket ultrasound device (PUD). Then, a trained physician and a resident performed 'blinded' analyses by viewing the video results on a computer. The primary objective was to test concordance between the blinded echo diagnosis and the CT scan. RESULTS: In the 100 LUS performed, the phased-array probe of the conventional machine and linear array probe of the PUD have the best concordance with the CT scan (Kappa coefficient=0.75 [CI 95%=0.54-0.96] and 0.62 [CI 95%=0.37-0.86], respectively) only for experts and trained physicians. The agreement was always poor for residents. Convex (abdominal) and linear transducers of conventional machines and the phased-array transducers (cardiac) of PUD have poor or very poor agreement, regardless of the physician's experience. CONCLUSION: Among the probes tested for LUS in acute patients, the cardiac probe of conventional machines and the linear probes of PUDs provide good diagnosis concordance with CT scans when performed by an expert and trained physician, but not by residents.

[Development of a standardized guide for optimizing drug adherence information to be dispensed during a pharmaceutical counseling with a multiple myeloma patient: Initial validation]. / Élaboration d'un guide standardisé d'informations d'optimisation de l'adhésion médicamenteuse à dispenser lors d'une consultation pharmaceutique au patient atteint de myélome multiple : validation initiale.

The safety of the community treatment with oral anticancer therapies is a strong theme of the cancer plan 2014-2019. The objective of this study was to develop a Pharmaceutical Counseling Guide to improve medication adherence in patients treated for multiple myeloma with oral anticancer therapies. A multidisciplinary professional working group selected a list of relevant medication adherence-related items that served as the framework for the design of the pharmaceutical counseling support materials in patient-accessible language. The readability, understanding and memorization of the information were validated in ten patients treated for myeloma. Twelve items were selected for treatment information (5 items), treatment planning (5 items), and adverse drug effects (2 items). A pharmacist guide, a patient guide, a medication schedule, and three self-questionnaires to evaluate medication knowledge and understanding of patients were developed. The patient test resulted in changes in these documents. This study carried out the initial validation of documents to standardize the pharmaceutical counseling for patients treated for myeloma so that it can be reproduced from one patient to another regardless of the pharmacist, by standardizing the information issued. This study needs to be completed by a final validation in myeloma patients, free from oral anticancer therapies.

Coronary heart disease and HRT in France: MISSION study prospective phase results.

OBJECTIVE: To determine the morbidity incidence associated with Hormone Replacement Therapy (HRTs) in postmenopausal women. This paper presents the results concerning the incidence of coronary heart disease (CHD). DESIGN: MISSION study started on 5 January 2004, the cutoff for data collection was June 2006 (follow-up no. 1). 'Exposed group': postmenopausal women currently on HRT, commonly prescribed in France or stopped < or =5 years previously. 'Unexposed group': never received HRT or stopped >5 years previously. RESULTS: Data were available for 4949 patients (without CHD at the beginning of the follow-up): 2693 Exposed group and 2256 Unexposed group. The incidence during follow-up no. 1 of postmenopausal CHD was not significantly different in the Exposed group (0.11%) compared with the Unexposed group (0.13%). In the Exposed group the time between start of HRT and menopause was 2.93 +/- 4.46 years in those who experienced CHD and 1.53 +/- 3.20 years in those who had no incidence of CHD (p = 0.3). CONCLUSION: In the MISSION cohort, no increased risk of CHD was found in the Exposed group compared with the Unexposed group.