How valid are proxy assessment of mental health and sleep comorbidities of patients with epilepsy using standardized questionnaires?

BACKGROUND: The study aimed to determine the level of agreement between patients with epilepsy and their proxies when assessing psychiatric comorbidities, sleep disorders, and medication adherence using standardized questionnaires. METHODS: This agreement study is an ancillary analysis of the PRERIES study, a matched case-control study exploring SUDEP risk factors. Controls aged 15 years and older, with active epilepsy or in remission for less than 5 years were recruited between 01/01/2011 and 03/31/2019. An interview was carried out by a trained psychologist on both the patient and a proxy-respondent. During these independent interviews, the following comorbidities were explored: psychiatric comorbidities using the MINI, the STAI- Y2 and NDDI-E scales, sleep disorders with the SDQ-SA and Epworth scales and medication adherence. Level of agreement between patient and their proxy was estimated using Gwet's AC1&2. RESULTS: Among the 107 patient-proxy dyads recruited, proxy respondents were mainly family members (65.4%) or spouses (30.8%). Exploration of present major depression showed excellent agreement at 0.81 [0.65;0.97], as well as exploration of dysthymia at 0.96 [0.61;1]. Suicidal risk evaluation had a lesser agreement at 0.77 [0.60;0.94]. Agreement on anxiety was moderate 0.5 [0.38;0.62]. For sleep disorder, SDQ-SA presented a better agreement than the Epworth questionnaire with respectively 0.73 [0.51;0.95] and 0.45 [0.26;0.63]. For medication adherence, the overall agreement rate was excellent (0.90 [0.78;1]). CONCLUSION: Exploration of potential risk factors through families can give valuable and relatively robust information, especially if the respondent lives with the patient, and should be retrieved, when possible, in usual clinical setting.

Mid-Term Sequelae of Surviving Patients Hospitalized in Intensive Care Unit for COVID-19 Infection: The REHCOVER Study.

OBJECTIVES: The objective of this prospective, single-center study was to explore the mid-term outcomes 6 to 9 months after hospitalization in an Intensive Care Unit (ICU) for severe COVID-19 infection. METHODS: Patients systematically underwent biological tests, pulmonary function tests, chest computed tomography (CT) scan, and psychological tests. RESULTS: Among 86 patients, including 71 (82.6%) men, median age of 65.8 years (56.7; 72.4), 57 (71.3%) patients presented post-COVID-19 asthenia, 39 (48.1%) muscle weakness, and 30 (36.6%) arthralgia. Fifty-two (64.2%) patients had a decreased diffusion capacity for carbon monoxide (DLCO) <80% and 16 (19.8%) had DLCO <60%. Chest CT-scans showed ground glass opacities in 35 (40.7%) patients, and reticular changes in 28 patients (33.7%), including fibrosis-like changes in 18 (21.7%) patients. Reticular changes and DLCO <60% were associated with length of stay in ICU, and reticular changes with higher maximal CRP level. The psychological questionnaires found 37.7% suffered from depression, 23.5% from anxiety, 42.4% from insomnia, and 9.4% from post-traumatic stress. Being female was associated with a higher frequency of depression and anxiety, with depression scores being associated with obesity. CONCLUSIONS: Many patients hospitalized in ICU for severe COVID-19 infection have mid-term sequelae. Additional studies on the prognostic factors seem necessary.

Stratifying sudden death risk in adults with drug-resistant focal epilepsy: The SUDEP-CARE score.

BACKGROUND AND PURPOSE: A clinical risk score for sudden unexpected death in epilepsy (SUDEP) in patients with drug-resistant focal epilepsy could help improve prevention. METHODS: A case-control study was conducted including (i) definite or probable SUDEP cases collected by the French National Sentinel Mortality Epilepsy Network and (ii) control patients from the French national research database of epilepsy monitoring units. Patients with drug-resistant focal epilepsy were eligible. Multiple logistic regressions were performed. After sensitivity analysis and internal validation, a simplified risk score was developed from the selected variables. RESULTS: Sixty-two SUDEP cases and 620 controls were included. Of 21 potential predictors explored, seven were ultimately selected, including generalized seizure frequency (>1/month vs. <1/year: adjusted odds ratio [AOR] 2.6, 95% confidence interval [CI] 1.25-5.41), nocturnal or sleep-related seizures (AOR 4.49, 95% CI 2.68-7.53), current or past depression (AOR 2.0, 95% CI 1.19-3.34) or the ability to alert someone of an oncoming seizure (AOR 0.57, 95% CI 0.33-0.98). After internal validation, a clinically usable score ranging from -1 to 8 was developed, with high discrimination capabilities (area under the receiver operating curve 0.85, 95% CI 0.80-0.90). The threshold of 3 has good sensitivity (82.3%, 95% CI 72.7-91.8), whilst keeping a good specificity (82.7%, 95% CI 79.8-85.7). CONCLUSIONS: These results outline the importance of generalized and nocturnal seizures on the occurrence of SUDEP, and show a protective role in the ability to alert someone of an oncoming seizure. The SUDEP-CARE score is promising and will need external validation. Further work, including paraclinical explorations, could improve this risk score.

Peri-operative Morbidity of Nissen Sleeve Gastrectomy: Prospective Evaluation of a Cohort of 365 Patients, Beyond the Learning Curve.

PURPOSE: Over the last decade, an important interest was taken to prevent the reflux following sleeve. A new variant, Nissen-sleeve, was described with the purpose to prevent GERD and to decrease the occurrence of leak. The current study reports the preliminary results of a prospective trial. MATERIALS AND METHODS: All consecutive patients who underwent a Nissen-Sleeve between January 2018 and September 2020 were included. Baseline characteristics including age, gender, weight, body mass index (BMI), GERD symptoms, and treatment were evaluated after 1 year. Operative time, length of stay, complication, and reoperation data were also collected. RESULTS: Three hundred sixty-five consecutive patients decided to undergo Nissen-sleeve: 75% females with median age of 41.2 years (+ / - 14.1) and an average BMI of 41.6 kg/m2 (+ / - 5.4). There were 16 cases (4.4%) of early postoperative complications (< 30 days): six cases of acute wrap perforation (1.6%), intraabdominal bleeding for 5 patients (1.4%), one case of wrap dilatation (0.3%), one case of acute complete aphagia, one case of incarcerated umbilical hernia, and 2 cases (0.5%) of pulmonary atelectasis/pneumonia and one venous pulmonary embolism. We recorded the following complications: 16 patients (4.4%) mild dysphagia; 3 patients (0.8%) chronic dysphagia; and 2 cases of wrap perforation that have been diagnosed 8 and 9 months respectively, after the procedure due to the use of steroids not associated with PPI intake. The mean operative time was 83 min (46-125 min). The conversion and mortality rates were nil. CONCLUSION: Following the initial learning curve and additional technical modifications, the Nissen-Sleeve appears to be a safe surgical technique with an acceptable early postoperative complication rate. CLINICAL TRIAL REGISTRATION: NCT02310178.

The triglycerides and glucose (TyG) index: A new marker associated with nonalcoholic steatohepatitis (NASH) in obese patients.

AIM: Diagnosis of nonalcoholic steatohepatitis (NASH) relies on liver biopsy. Noninvasive tools would be useful to target patients to refer for a biopsy. We aimed to determine the diagnostic value of the triglycerides and glucose (TyG) index, an insulin-resistance indicator, to predict NASH. METHODS: Our study included grade II-III obese patients aged 18-65 years undergoing bariatric surgery and included in the COMET (COllection of MEtabolic Tissues) biobank (NCT02861781). Liver biopsies performed during bariatric surgery were collected from the biobank along with blood derivatives. Biopsies were analysed according to the steatosis, activity and fibrosis (SAF) scoring system to diagnose NASH, nonalcoholic fatty liver disease (NAFLD), and fibrosis. Logistic regression models were performed to identify factors predicting NASH, NAFLD, and fibrosis. RESULTS: Of 238 analysed subjects (mean age 43±12 years, 33.6% men), 29% had type 2 diabetes. Steatosis was present in 67.2%, while NASH and advanced fibrosis (stage F3) were diagnosed in 18.1% and 2.9% respectively. TyG index was independently associated with NASH (odds ratio (OR): 4.7 [95% confidence interval: 2.3;9.5] P < 0.0001), NAFLD (OR: 2.0 [1.1;3.7] P = 0.03) and stages 2-3 fibrosis (OR: 4.0 [1.5;10.8] P = 0.007). NASH was also predicted by gamma-glutamyl transferase (GGT) with an area under the ROC curve: 0.79 [0.71;0.87 P = 0.04] for GGT and TyG index combined. CONCLUSION: In our cohort of severely obese patients, TyG index, when associated with GGT level, exhibited high diagnostic performance to predict NASH. Although validation in larger populations is needed, this result may be of considerable clinical value to predict need for liver biopsy.

Recommendations for risk management and better living with epilepsy. Phenomenological study of the experience of patients, relatives, and bereaved families.

OBJECTIVE: To understand the lived experience of people with epilepsy (PWE) and their relatives, the risks associated with epilepsy, the information received from healthcare professionals, and the reaction to this information. METHODS: Qualitative phenomenological study conducted between 2016 and 2018. Individual semi-directive in-depth interviews were performed based on a triangulation of sources in three study groups: PWE, relatives of PWE, and bereaved families. Interviews were analyzed continuously, using a semiopragmatic method until data saturation. RESULTS: Interviews with PWE (N = 16), relatives of PWE (N = 8), and bereaved families (N = 10) led to several observations: (i) The stigmatizing representations of epilepsy and its constraints lead to a feeling of abnormality which determines the behavior of patients and their relatives; (ii) The global uncertainty surrounding epilepsy is an obstacle to the delivery of clear and personalized information by professionals, and, consequently, to empowerment; (iii) The communication skills of the physician have an impact on the lived experiences of patients and relatives; (iv) Better knowledge on direct mortal epilepsy-related risk could influence the perception of danger to oneself, and help find a balance between overprotection and trivialization. The experience of the patients and relatives led them to formulate concrete recommendations: (i) for the general public: to run information campaigns in order to limit stigmatization; (ii) for caregivers: to provide personalized and detailed information without minimizing the risks, in order to enable patients to "live by setting these risks"; (iii) for patients: to have a trusted person who is informed and trained in seizure management, to join patient associations. CONCLUSION: Our study points out that stigma, uncertainty, and lack of clarity of information are all barriers to patient empowerment. In order to provide prompt and personalized information on how to live with epilepsy while managing the risks, physicians need to develop person-centered communication skills. Future research is also required for the development of tools to facilitate this communication.

Diagnostic Value of Patient-Reported and Clinically Tested Olfactory Dysfunction in a Population Screened for COVID-19.

Importance: Recent studies have suggested that olfactory dysfunction and gustatory dysfunction are associated with coronavirus disease 2019 (COVID-19). However, olfaction has been evaluated solely on reported symptoms, after COVID-19 diagnosis, and in both mild and severe COVID-19 cases, but rarely has it been assessed in prospectively unselected populations. Objective: To evaluate the diagnostic value of a semiobjective olfactory test developed to assess patient-reported chemosensory dysfunction prior to testing for the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in patients attending a COVID-19 screening facility. Design, Setting, and Participants: This prospective diagnostic study with participants and observers blinded to COVID-19 status was conducted in a COVID-19 screening center of a tertiary university hospital in France from March 23 to April 22, 2020. Participants were 854 consecutively included health care workers or outpatients with symptoms or with close contact with an index case. Exclusion criteria were prior chemosensory dysfunction, testing inability, or contraindications (n = 45). Main Outcomes and Measures: Participants were interviewed to ascertain their symptoms and then underwent Clinical Olfactory Dysfunction Assessment (CODA), an ad hoc test developed for a simple and fast evaluation of olfactory function. This assessment followed a standardized procedure in which participants identified and rated the intensity of 3 scents (lavender, lemongrass, and mint) to achieve a summed score ranging from 0 to 6. The COVID-19 status was assessed using reverse transcriptase-polymerase chain reaction to detect the presence of SARS-CoV-2 in samples collected via nasopharyngeal swab (reference standard) to calculate the diagnostic values of patient-reported chemosensory dysfunction and CODA. Results: Of 809 participants, the female to male sex ratio was 2.8, and the mean (SD) age was 41.8 (13.0) years (range, 18-94 years). All participants, if symptomatic, had mild disease at the time of testing, and 58 (7.2%) tested positive for SARS-CoV-2. Chemosensory dysfunction was reported by 20 of 58 participants (34.5%) with confirmed COVID-19 vs 29 of 751 participants (3.9%) who tested negative for COVID-19 (absolute difference, 30.6% [95% CI, 18.3%-42.9%]). Olfactory dysfunction, either self-reported or clinically ascertained (CODA score ≤3), yielded similar sensitivity (0.31 [95% CI, 0.20-0.45] vs 0.34 [95% CI, 0.22-0.48]) and specificity (0.97 [95% CI, 0.96-0.98) vs 0.98 [95% CI, 0.96-0.99]) for COVID-19 diagnosis. Concordance was high between reported and clinically tested olfactory dysfunction, with a Gwet AC1 of 0.95 (95% CI, 0.93-0.97). Of 19 participants, 15 (78.9%) with both reported olfactory dysfunction and a CODA score of 3 or lower were confirmed to have COVID-19. The CODA score also revealed 5 of 19 participants (26.3%) with confirmed COVID-19 who had previously unperceived olfactory dysfunction. Conclusions and Relevance: In this prospective diagnostic study of outpatients with asymptomatic or mild to moderate COVID-19, systematically assessed anamnesis and clinical testing with the newly developed CODA were complementary and specific for chemosensory dysfunction. Olfactory dysfunction was suggestive of COVID-19, particularly when clinical testing confirmed anamnesis. However, normal olfaction was most common among patients with COVID-19.

Evaluating the impact of the antrum size following laparoscopic sleeve gastrectomy: a randomized multicenter study.

BACKGROUND: The effect of laparoscopic sleeve gastrectomy (LSG) on gastroesophageal reflux disease (GERD) remains discordant and highly related to the surgical technique. GERD and weight regain are probably understudied by prospective clinical studies depending on different technical factors. OBJECTIVES: The purpose of this article is to evaluate the effect of extent to which the antrum is resected on GERD following LSG but also on early complications and short-term weight loss results. SETTING: University Hospital, France. METHODS: Patients were randomly assigned in group A (172 patients), LSG with antral resection, or group B (174 patients), LSG with antral preservation. The baseline characteristics collected were demographic characteristics and anthropometric data (age, sex, body mass index), presence of GERD clinical characteristics, ± pH-metry, postoperative complications, or gastrin level. RESULTS: A total of 279 patients underwent LSG and they were included in the final analysis. The GERD analyzed at 3 months postoperatively by pH-metry was observed for 57.8% in group A and for 52.4% of patients in group B (P = .4819). There was no statistically significant difference (P = .3755) between the 2 groups at 1 year after surgery (group A, 49.5% versus group B, 43.6%). The gastrin serum level was analyzed 1 year after surgery for a total of 107 patients. For group A, the mean gastrin level was 97.4 ± 85.9 pg/mL, which was inferior compared with group B (150.6 ± 152.4 pg/mL) with no statistical difference (P = .067). The recorded excess weight loss for group A was 79.67% (± 28.88) with no statistically significant difference with group B 74.46% (± 36.61) (P = .3678). The mortality rate was nil. We recorded 5 cases of staple line leakage (3 in group A and 2 in group B); 11 patients presented bleeding (3 in group A and 8 group B), and 4 patients presented with gastric stenosis (2 in group A and 2 in group B). CONCLUSIONS: The antrum preservation has no significant difference in terms of reflux, weight loss, or complications at 3 or 12 months following LSG. The only significant difference was achieved for nausea and vomiting symptoms, which were more significant for the antrum resection group. Further clinical trials with newer procedures will indicate the factors that can diminish the reflux following LSG. Furthermore, the conservation of a large part of the antrum may be helpful to convert the sleeve to another bariatric procedure (transit bipartition).

Efficacy of a Test-Retest Strategy in Residents and Health Care Personnel of a Nursing Home Facing a COVID-19 Outbreak.

OBJECTIVE: To assess the American Testing Guidance for Nursing Homes (NHs)-updated May 19, 2020-with a new COVID-19 case. DESIGN: Case investigation. SETTING AND SUBJECTS: All 79 residents and 34 health care personnel (HCP) of an NH. METHODS: Seven days after identification of a COVID-19 resident, all residents and HCP underwent real-time reverse-transcriptase polymerase chain reaction (rRT-PCR) testing for SARS-CoV-2 with nasopharyngeal swabs. This was repeated weekly in all previously negative subjects until the testing identified no new cases, and in all positive subjects until the testing was negative. COVID-19 infection prevention and control (IPC) measures were implemented in all residents and HCP with positive testing or with COVID-19 symptoms. Standard IPC was also implemented in all HCP. Six weeks after initial testing, all residents underwent testing for enzyme-linked immunosorbent assay-based IgG antibodies directed against the SARS-CoV-2. Symptoms were serially recorded in residents and HCP. RESULTS: A total of 36 residents had a positive rRT-PCR at baseline and 2 at day 7. Six HCP had a positive rRT-PCR at baseline and 2 at day 7. No new COVID-19 cases were diagnosed later. Among the SARS-CoV-2-positive cases, 6 residents (16%) and 3 HCP (37%) were asymptomatic during the 14 days before testing. Twenty-five residents (92.3%) and all 8 HCP (100%) with a positive rRT-PCR developed IgG antibodies against SARS-CoV-2. Among the residents and HCP always having tested negative, 2 (5%) and 5 (11.5%), respectively, developed IgG antibodies against SARS-CoV-2. These 2 residents had typical COVID-19 symptoms before and after testing and 2/5 HCP were asymptomatic before and after testing. CONCLUSIONS AND IMPLICATIONS: This study shows the validity of the updated American Testing Guidance for Nursing Homes (NHs). It suggests implementing COVID-19 IPC in both residents and HCP with positive testing or COVID-19 symptoms and warns that asymptomatic HCP with repeated negative rRT-PCR testing can develop antibodies against SARS-CoV-2.

Rehabilitation of the upper arm early after stroke: Video games versus conventional rehabilitation. A randomized controlled trial.

BACKGROUND: Few rehabilitation methods have proven their efficacy in increasing sensori-motor recovery and/or function of the upper limb (UL) after stroke. Video games (VGs) are promising tools in this indication. OBJECTIVE: To compare UL rehabilitation by using VGs and conventional rehabilitation (CR) in patients with sub-acute stroke. DESIGN: Single-blind, multicentric trial, with central randomization and stratification by center. SETTING: Physical and rehabilitation medicine departments of 2 university hospitals. PARTICIPANTS: Adults within 3 months after a first vascular cerebral accident, with UL Fugl Meyer Score (UL-FMS)<30/66 and without major cognitive impairment. INTERVENTION: A 45-min additional session of conventional occupational therapy (OT) or a VG-based OT session as add-on therapy to usual rehabilitation programs, 5 days/week for 6 weeks. MAIN OUTCOME MEASURES: Primary outcome: UL-FMS. Secondary outcome: Box and Block Test (BBT), Wolf Motor Function test (WMFT), Motor Activity Log (MAL), Barthel Index and quality of life (SF-36). RESULTS: We included 51 patients (20 women) at a mean (SD) of 27.2 (19.4) days post-stroke (mean age 58 years [range 24-83]), 26 in the CR group and 25 in the VG group (23 in each group at 6-month follow-up). The mean duration of the additional rehabilitation session was similar in both groups: 29.3 (4.3) vs 28.0 (4.4) min in CR and VG groups. Shoulder pain occurred in 4 patients in the VG group versus 7 in the CR group. At day 45, gain in UL-FMS did not significantly differ between the groups (CR mean 17.8 [14.6] vs VG 24.1 [14.8]; P=0.10), whereas gain in BBT was doubled in the VG group (CR 7.4 [12.2] vs VG 15.7 [16.3]; P=0.02). At 6-month follow-up, the study was inconclusive about between-group differences in UL-FMS, BBT and other criteria. Post-hoc analysis showed that gains in UL-FMS or BBT were significantly higher in the VG than CR group for patients included within 30 days post-stroke. CONCLUSION: In general, we cannot conclude that video gaming and conventional OT led to different long-term sensorimotor recovery of the UL after sub-acute stroke. However, when applied within the first month after stroke, video gaming was more efficient than conventional rehabilitation on both sensorimotor recovery and gross grasping function. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01554449).

Natural history, dynamics, and ecology of human papillomaviruses in genital infections of young women: protocol of the PAPCLEAR cohort study.

INTRODUCTION: Human papillomaviruses (HPVs) are responsible for one-third of all cancers caused by infections. Most HPV studies focus on chronic infections and cancers, and we know little about the early stages of the infection. Our main objective is to better understand the course and natural history of cervical HPV infections in healthy, unvaccinated and vaccinated, young women, by characterising the dynamics of various infection-related populations (virus, epithelial cells, vaginal microbiota and immune effectors). Another objective is to analyse HPV diversity within hosts, and in the study population, in relation to co-factors (lifestyle characteristics, vaccination status, vaginal microbiota, human genetics). METHODS AND ANALYSIS: The PAPCLEAR study is a single center longitudinal study following 150 women, aged 18-25 years, for up to 2 years. Visits occur every 2 or 4 months (depending on HPV status) during which several variables are measured, such as behaviours (via questionnaires), vaginal pH, HPV presence and viral load (via qPCR), local concentrations of cytokines (via MesoScale Discovery technology) and immune cells (via flow cytometry). Additional analyses are outsourced, such as titration of circulating anti-HPV antibodies, vaginal microbiota sequencing (16S and ITS1 loci) and human genotyping. To increase the statistical power of the epidemiological arm of the study, an additional 150 women are screened cross-sectionally. Finally, to maximise the resolution of the time series, participants are asked to perform weekly self-samples at home. Statistical analyses will involve classical tools in epidemiology, genomics and virus kinetics, and will be performed or coordinated by the Centre National de la Recherche Scientifique (CNRS) in Montpellier. ETHICS AND DISSEMINATION: This study has been approved by the Comité de Protection des Personnes Sud Méditerranée I (reference number 2016-A00712-49); by the Comité Consultatif sur le Traitement de l'Information en matière de Recherche dans le domaine de la Santé (reference number 16.504); by the Commission Nationale Informatique et Libertés (reference number MMS/ABD/AR1612278, decision number DR-2016-488) and by the Agence Nationale de Sécurité du Médicament et des Produits de Santé (reference 20160072000007). Results will be published in preprint servers, peer-reviewed journals and disseminated through conferences. TRIAL REGISTRATION NUMBER: NCT02946346; Pre-results.

The effect of excessive fat tissue on the measure of bone mineral density by dual X-ray absorptiometry: the impact of substantial weight loss following sleeve gastrectomy.

PURPOSE: Dual-energy X-ray absorptiometry (DXA) is used in clinical routine to determine areal bone mineral density (aBMD). However, it is not clear whether excessive fat mass or substantial weight loss modify the aBMD measurements. The aim of this study was to evaluate the effect of soft tissue composition on aBMD measured by DXA using a clinical model (i.e. sleeve gastrectomy: SG) that induces substantial body weight loss. METHODS: Areal bone mineral density and body composition (fat mass: FM and lean tissue mass: LTM) were determined by DXA in 41 obese patients (33 women, 80.5%) just before SG and 1 month later. RESULTS: One month after SG, mean weight loss was -9.8 ± 2.6 kg, with a significant decrease in LTM and FM (kg) ranging from -7.3% to -9.5%. The relative variation in aBMD was increased at the lumbar spine (2.45 ± 3.44%) and decreased at the hip (-1.47 ± 2.28%), whereas no variation was observed for the whole body and radius. The variation in aBMD at the lumbar spine was inversely correlated with variations in weight, whole-body FM and trunk FM, but not LTM. CONCLUSION: This study shows evidence of a potential effect of body composition, particularly FM, on aBMD. However, given the modest change in aBMD, which was close to the precision error of aBMD measurements, it appears that significant weight loss does not have a clinically significant impact on the evaluation of aBMD using DXA.

Effectiveness of a programme delivered in a falls clinic in preventing serious injuries in high-risk older adults: A pre- and post-intervention study.

OBJECTIVE: To evaluate whether a multifactorial programme delivered in a real practice setting would help prevent serious fall-related injuries in high-risk older patients. DESIGN: A 6-month pre-post intervention study in 134 fallers (81.6 ± 7.2 years) consecutively referred to a fall prevention clinic after repeated falls in the previous year or after a fall associated with balance, gait, or strength disorders. The programme was delivered by a physiotherapist, an occupational therapist, a podiatrist, and a geriatrician based on a 3-hour fall risk assessment. RESULTS: The proportion of patients with serious and moderate fall-related injuries was significantly lower in the 6 months after than in the 6-months preceding clinic attendance [8 (6.1%) vs 40 (30.5%), and 11 (8.2%) vs 19 (14.2%), respectively; p < 0.0001], as were the overall proportion of fallers (32.1% vs 95.4%; p < 0.0001) and the number of falls per patient (-5.2 ± -20.4; p < 0.0001). When compared with baseline, fear of falling at 6 months was reduced (p < 0.05), mobility was maintained, and the proportion of patients with an ADL score ≤ 2 was increased (5.6% vs 9.7% respectively; p < 0.001). Adherence to the main recommendations and satisfaction with the programme were > 75% at 6 months post-clinic. CONCLUSIONS: A multifactorial fall prevention programme delivered by a multidisciplinary geriatric team in older patients at high risk of falling helps to reduce over a 6-month period the risk of serious and moderate injuries related to falls, the risk of falling, and the fear of falling, and helps to maintain mobility and improve functional status.

Relevance and feasibility of a systematic screening of multimorbidities in patients with chronic inflammatory rheumatic diseases.

OBJECTIVES: EULAR recently proposed to screen multimorbidities in chronic inflammatory rheumatic diseases. The aims of the study were to define the most common multimorbidities in chronic inflammatory rheumatic diseases, compare the screening approach performed in the clinic with the recent EULAR recommendations, validate the points to consider for the systematic standardized multimorbidity screening proposed by EULAR and assess feasibility of such a screening in a daily clinic. METHODS: Data were collected prospectively during a 1-day multimorbidity clinic. Diabetes, hypertension, CVD damage, chronic respiratory diseases, osteoporosis and preventive measures were assessed. The comparison with EULAR points to consider was performed retrospectively. RESULTS: We included 200 consecutive patients (157 with rheumatoid arthritis, 37 spondyloarthritis, and 6 connective tissue diseases or vasculitis). The most common multimorbidities already diagnosed in our patients were hypertension (26%) and diabetes (7.5%). Screening showed that 61.5% (CI95%: 54.6%-67.9%) patients presented at least one undiagnosed or uncontrolled diseases: diabetes (6%), hypertension (20.6%), dyslipidemia (16.1%) valvulopathies (16.8%), peripheral artery disease (4.5%); carotid stenosis (6.5%) and aortic aneurysm (5.5%). Overall, 39.9% patients had incomplete cancer screening and 52.8% incomplete vaccine schedule. Undiagnosed pulmonary obstruction and risk of sleep apnea were suspected in 15.5% and 40.1% patients, respectively. CONCLUSION: This study underlines the relevance of a systematic screening of multimorbidities in chronic inflammatory rheumatic diseases and its feasibility in a 1-day clinic. Spirometry and sleep apnea screening should be added to EULAR points to consider. The long-term impact of such screening needs to be evaluated.

Upper Limb Isokinetic Strengthening Versus Passive Mobilization in Patients With Chronic Stroke: A Randomized Controlled Trial.

OBJECTIVE: To assess the benefit of isokinetic strengthening of the upper limb (UL) in patients with chronic stroke as compared to passive mobilization. DESIGN: Randomized blinded assessor controlled trial. SETTING: Physical Medicine and Rehabilitation departments of 2 university hospitals. PARTICIPANTS: Patients (N=20) with incomplete hemiplegia (16 men; mean age, 64y; median time since stroke, 32mo). INTERVENTIONS: A 6-week comprehensive rehabilitation program, 3d/wk, 3 sessions/d. In addition, a 45-minute session per day was performed using an isokinetic dynamometer, with either isokinetic strengthening of elbow and wrist flexors/extensors (isokinetic strengthening group) or passive joint mobilization (control group). MAIN OUTCOME MEASURES: The primary endpoint was the increase in Upper Limb Fugl-Meyer Assessment (UL-FMA) score at day 45 (t1). Secondary endpoints were increases in UL-FMA scores, Box and Block Test scores, muscle strength, spasticity, and Barthel Index at t1, t2 (3mo), and t3 (6mo). RESULTS: Recruitment was stopped early because of excessive fatigue in the isokinetic strengthening group. The increase in UL-FMA score at t1 was 3.5±4.4 in the isokinetic strengthening group versus 6.0±4.5 in the control group (P=.2). Gains in distal UL-FMA scores were larger (3.1±2.8) in the control group versus 0.6±2.5 in the isokinetic strengthening group (P=.05). No significant group difference was observed in secondary endpoints. Mixed models confirmed those results. Regarding the whole sample, gains from baseline were significant for the UL-FMA at t1 (+4.8; P<.001), t2, and t3 and for the Box and Block Test at t1 (+3; P=.013) and t2. CONCLUSIONS: In a comprehensive rehabilitation program, isokinetic strengthening did not show superiority to passive mobilization for UL rehabilitation. Findings also suggest a sustained benefit in impairments and function of late UL rehabilitation programs for patients with stroke.

On-line hemodiafiltration did not induce an overproduction of oxidative stress and inflammatory cytokines in intensive care unit-acute kidney injury.

BACKGROUND: Though on-line intermittent hemodiafiltration (OL-IHDF) is a routine therapy for chronic dialysis patients, it is not yet widespread used in critically ill patients. This study was undergone to evaluate efficiency and tolerance of OL-IHDF and to appreciate inflammatory consequences of its use in intensive care unit (ICU)-acute kidney injury (AKI) patients. METHODS: In this prospective cohort study conducted in a medical academic ICU in France, 30 AKI patients who underwent OL-IHDF were included. OL-HDF used an ultrapure water production: AQ 1250 line with double reverse osmosis, a generator 5008 with a 1.8m2 dialyzer with Polysulfone membrane (Fresenius Medical Care). Tolerance and efficiency of OL-IHDF were evaluated as well as its inflammatory risk by the measurement of plasma concentrations of proinflammatory (Interleukin 6, IL1ß, IL8, Interferon γ) and anti-inflammatory (IL4, IL10) cytokines, Epidermal growth factor (EGF), Vascular Endothelial growth factor (VEGF) and Macrophage Chemoattractive Protein-1 (MCP-1) before and after sessions. RESULTS: Intradialytic hypotensive events were observed during 27/203 OL-IHDF sessions accounting for a mal-tolerated session's rate at 13.3%. Mean delivered urea Kt/V per session was 1.12 ± 0.27 with a percentage of reduction for urea, creatinine, ß2-microglobulin and cystatine C at 61.6 ± 8.8%, 55.3 ± 6.7%, 51.5 ± 8.7% and 44.5 ± 9.8% respectively. Production of superoxide anion by leukocytes, mean levels of pro- and anti-inflammatory cytokines and plasmatic concentrations of EGF, VEGF and MCP-1 did not differ before and after OL-IHDF sessions. We observed however a significant decrease of mean TNFα plasmatic concentrations from 8.2 ± 5.8 to 4.8 ± 3.5 pg/ml at the end of OL-IHDF. CONCLUSIONS: OL-IHDF was not associated with an increase in pro and anti-inflammatory cytokines, oxidative stress or EGF, VEGF and MCP-1 in AKI patients and seems therefore a secure and feasible modality in ICUs.

Laparoscopic sleeve gastrectomy: Effect on long-term remission for morbidly obese patients with type 2 diabetes at 5-year follow up.

BACKGROUND: In the short-term, laparoscopic sleeve gastrectomy has been shown to be effective for the treatment of the type 2 diabetes in patients with severe obesity. There are few data with greater follow-up. Our aim was to evaluate the results of laparoscopic sleeve gastrectomy on the control of type 2 diabetes in patients with severe obesity at 5 years at the University Hospital, France. METHODS: From a total of 355 patients with severe obesity operated between January 2006 and June 2010, 52 (15%) had a diagnosis of type 2 diabetes before undergoing laparoscopic sleeve gastrectomy. RESULTS: There were 31 females (60%) and 21 males (40%), with a mean age of 51 ± 10 years (range 27-67) with a mean body mass index of 48 ± 10 kg/m2 (range 35-82). The mean duration of type 2 diabetes was 10.8 ± 10.8 years before bariatric operation. The preoperative glycated hemoglobin was 8 ± 2% (range 5.9-12.8) in 45 patients; 17 patients (38%) had levels of glycated hemoglobin ≥9%. Three patients (6%) required insulin alone, 4 (8%) were taking oral antidiabetic medicine and insulin, and the remaining 45 patients (87%) were taking only oral antidiabetic medicines. The complete data regarding weight loss at 5-year follow-up were obtained for 46 patients, yielding an overall follow-up rate of 89%. The prolonged remission of type 2 diabetes achieved at 1 year that persisted at 5 years of follow-up was present in 9 patients (17%). No patient with complete remission of their type 2 diabetes required insulin preoperatively. Improvement of type 2 diabetes was observed in 30 patients (58%) at 1 year, which was maintained for 27 patients (52%) at 5-year follow-up. CONCLUSION: Laparoscopic sleeve gastrectomy has demonstrated a moderate efficacy in the treatment morbidly obese patients with type 2 diabetes. Markedly increased preoperative glycated hemoglobin levels, older age, and preoperative need for insulin treatment may be the factors predicting failure of complete remission of type 2 diabetes after laparoscopic sleeve gastrectomy.

Body composition changes in the first month after sleeve gastrectomy based on gender and anatomic site.

BACKGROUND: Sleeve gastrectomy (SG) induces acute weight loss, but its impact on the very early postoperative changes in body composition (BC) is less clear. OBJECTIVES: This longitudinal study examined the BC changes in the first month after SG according to gender and anatomic site. METHODS: BC (lean tissue mass [LTM] and fat mass [FM]) were determined by dual-energy x-ray absorptiometry in 41 obese patients (33 women, 80.5%) just before SG and 1 month later. SETTING: University hospital of Montpellier, France. RESULTS: One month after SG, mean weight loss was -9.8±2.6 kg, with a significant decrease in LTM and FM (kg) ranging from -7.3% to 9.5%, depending on site. FM (kg) loss in men exceeded that in women at whole body, upper limbs, and trunk. FM (%) and the LTM/FM ratio decreased only in the trunk in men and the lower limbs in women, but the gender difference was only observed for the trunk. In women, age was positively correlated with relative FM variation (% and kg) in the lower limbs and negatively correlated with LTM and LTM/FM. In men, weight was negatively correlated with the relative LTM and FM (kg) variations in the upper limbs. CONCLUSION: SG induces acute weight loss, but this loss comprises losses in both FM and LTM. Because excessive LTM loss can have deleterious consequences, preventive strategies should be implemented soon after bariatric surgery. The specific changes in BC are highlighted according to gender and anatomic site.

Treatment tolerance and patient-reported outcomes favor online hemodiafiltration compared to high-flux hemodialysis in the elderly.

Large cohort studies suggest that high convective volumes associated with online hemodiafiltration may reduce the risk of mortality/morbidity compared to optimal high-flux hemodialysis. By contrast, intradialytic tolerance is not well studied. The aim of the FRENCHIE (French Convective versus Hemodialysis in Elderly) study was to compare high-flux hemodialysis and online hemodiafiltration in terms of intradialytic tolerance. In this prospective, open-label randomized controlled trial, 381 elderly chronic hemodialysis patients (over age 65) were randomly assigned in a one-to-one ratio to either high-flux hemodialysis or online hemodiafiltration. The primary outcome was intradialytic tolerance (day 30-day 120). Secondary outcomes included health-related quality of life, cardiovascular risk biomarkers, morbidity, and mortality. During the observational period for intradialytic tolerance, 85% and 84% of patients in high-flux hemodialysis and online hemodiafiltration arms, respectively, experienced at least one adverse event without significant difference between groups. As exploratory analysis, intradialytic tolerance was also studied, considering the sessions as a statistical unit according to treatment actually received. Over a total of 11,981 sessions, 2,935 were complicated by the occurrence of at least one adverse event, with a significantly lower occurrence in online hemodiafiltration with fewer episodes of intradialytic symptomatic hypotension and muscle cramps. By contrast, health-related quality of life, morbidity, and mortality were not different in both groups. An improvement in the control of metabolic bone disease biomarkers and ß2-microglobulin level without change in serum albumin concentration was observed with online hemodiafiltration. Thus, overall outcomes favor online hemodiafiltration over high-flux hemodialysis in the elderly.

Five-year results of laparoscopic sleeve gastrectomy for the treatment of severe obesity.

BACKGROUND: Since 2011, the most used bariatric technique in France has been the sleeve gastrectomy. There are still few studies exploring the medium and long-term results of this technique. OBJECTIVE: To describe medium-long-term (5 years) results of a cohort of CHU Montpellier experience in sleeve gastrectomy for morbid obesity. METHODS: All patients that underwent laparoscopic sleeve gastrectomy (LSG) from January 2005 to June 2013 were included in this study. RESULTS: A total of 1050 patients were operated. 72.86% were women. The mean preoperative BMI was 44.58 kg/m2 (±7.71). A total of 183 patients (18.5%) were super-obese (BMI > 50 kg/m2). LSG was proposed as primary procedure, and also after failure of adjustable gastric banding in 169 patients (16.9%) or after vertical banded gastroplasty in 7 cases (0.7%). There were 38 postoperative gastric fistulas (3.8%) and 3 of them required some kind of bypass to be definitively treated. There were also 34 hemorrhages (3.4%) of which 21 were reoperated for hemostasis. Two gastric stenoses at the angulus (0.2%) were managed with dilation or RYGB. Overall reoperative rate was 6.8%. One patient died of pulmonary embolism. Most common late complication was GERD (39.1%). After 3, 4 and 5 years of LSG, the average of %EBL was, respectively, 75.95% (±29.16) (382 patients), 73.23% (±31.08) (222 patients) and 69.26% (±30.86) (144 patients). The success rate at 5 years was 65.97% (95 patients). The improvement or remission of comorbidities was found, respectively, in 88.4 and 57.2% of diabetic patients; 76.9 and 19.2% for hypertensive patients and 98 and 85% for patients with sleep apnea syndrome. CONCLUSION: LSG is a bariatric surgery technique that presents a very good risk/benefit ratio. Five-year results are very convincing. GERD is the main long-term complication.