Clinical evaluation of an over-the-counter hearing aid (TEO First®) in elderly patients suffering of mild to moderate hearing loss.

BACKGROUND: Presbycusis has a direct influence on autonomy of the elderly but hearing aids lack of affordability. Moreover a recent review demonstrate that electroacoustic characteristics of OTC hearing aids were generally not suitable for the elderly people. In our study, we assessed the clinical value of a new over-the-counter (OTC) hearing aid device (TEO First®) in the elderly. METHOD: This prospective monocentric open label study included patients over 60 years of age with a mild to moderate presbycusis. Patients were assessed with acceptable noise level test (ANL), pure tone (PTA) and speech (SA) audiometry in silent and noisy environment, with and without TEO First®. A Glasgow Hearing Aid Benefit Profile, acceptability and satisfaction surveys were completed after one month of using the device. RESULTS: Thirty one patients were included. There was an improvement of hearing with TEO First® in silence (SA: +39.2 %, p < 0.01; PTA: -9.04 dB, p < 0.01) or in noise (SA +47.7 %, p < 0.01; PTA: -5.23 dB, p < 0.05). After one month of use of the device, quality of life has improved with regards to the following parameters: decrease of perceived hearing difficulties during conversation without background noise (-9.6 % p = 0.018), in conversation with several people (-16.2 % p = 0.0076), decrease of negative emotions while watching TV (-18.5 % p = 0.011), during conversation without background noise (-16.5 % p = 0.0024), during conversation in noisy background (-17.1 % p = 0.027) and during conversation with several people (-20 % p = 0.014). The acceptability of the device was low to moderate. CONCLUSION: TEO First® is an effective OTC hearing aid that improves the patient's quality of life. TRIAL REGISTRATION: Current Controlled Trials NCT01815788.

Quality of life and Comprehensive Geriatric Assessment (CGA) in older adults receiving Accelerated Partial Breast Irradiation (APBI) using a single fraction of Multi-Catheter Interstitial High-Dose Rate Brachytherapy (MIB). The SiFEBI phase I/II trial.

OBJECTIVES: The SiFEBI trial demonstrated that a post-operative Multicatheter Interstitial Brachytherapy (MIB) appears feasible and with acceptable toxicity in older adults aged 70 years and older presenting with low-risk breast cancer. The aim of the present ancillary study was to analyze the quality of life and Comprehensive Geriatric Assessment (CGA) domains within 6 months in older adults receiving Accelerated Partial Breast Irradiation (APBI) using a single fraction of MIB. MATERIALS AND METHODS: From 11/2012 to 09/2014, 37 patients were included and 26 were evaluable. Patients (pts) aged 70 years and older with a Balducci score of 1 or 2 and presenting with low-risk breast cancer were prospectively enrolled in this phase I/II trial (NCT01727011). After lumpectomy, intra-operative catheter implantation was performed for post-operative APBI after pathological findings. Quality of life (QoL) evaluation and CGA were scheduled at baseline and 1, 3, and 6 months after APBI. Autonomy decline was defined as a 1-point decrease in Activities of Daily Living (ADL). RESULTS: Mean age was 77 years. Within the first 6 months of follow-up, no autonomy decline was observed in ADL, 3 patients had an autonomy decline in Instrumental Activities of Daily Living (IADL) and 2 patients had a slower gait speed but no changes in cognitive function, nutritional status, and depression screening. Global QoL was quite similar at baseline compared to 1, 3, and 6 months. No differences were observed for functional items. CONCLUSION: APBI based on a single fraction of MIB in older adults with low-risk breast cancer appears to be feasible with a minimal loss of autonomy regarding IADL, no loss of autonomy in ADL, an acceptable decrease in other CGA domains, and with no impact on global quality of life.

Safety and efficacy of deep brain stimulation in refractory cluster headache: a randomized placebo-controlled double-blind trial followed by a 1-year open extension.

Chronic cluster headache (CCH) is a disabling primary headache, considering the severity and frequency of pain attacks. Deep brain stimulation (DBS) has been used to treat severe refractory CCH, but assessment of its efficacy has been limited to open studies. We performed a prospective crossover, double-blind, multicenter study assessing the efficacy and safety of unilateral hypothalamic DBS in 11 patients with severe refractory CCH. The randomized phase compared active and sham stimulation during 1-month periods, and was followed by a 1-year open phase. The severity of CCH was assessed by the weekly attacks frequency (primary outcome), pain intensity,sumatriptan injections, emotional impact (HAD) and quality of life (SF12). Tolerance was assessed by active surveillance of behavior, homeostatic and hormonal functions.During the randomized phase, no significant change in primary and secondary outcome measures was observed between active and sham stimulation. At the end of the open phase, 6/11 responded to the chronic stimulation(weekly frequency of attacks decrease [50%), including three pain-free patients. There were three serious adverse events, including subcutaneous infection, transient loss of consciousness and micturition syncopes. No significant change in hormonal functions or electrolytic balance was observed. Randomized phase findings of this study did not support the efficacy of DBS in refractory CCH, but open phase findings suggested long-term efficacy in more than 50% patients, confirming previous data, without high morbidity. Discrepancy between these findings justifies additional controlled studies (clinicaltrials.gov number NCT00662935).

The Desire to Better Understand Older Adults with Solid Tumors to Improve Management: Assessment and Guided Interventions-The French PACA EST Cohort Experience.

Todays challenge in geriatric oncology is to screen patients who need geriatric follow-up. The main goal of this study was to analyze factors that identify patients, in a large cohort of patients with solid tumors, who need more geriatric interventions and therefore specific follow-up. Between April 2012 and May 2018, 3530 consecutive patients were enrolled in the PACA EST cohort (France). A total of 3140 patients were finally enrolled in the study. A Comprehensive Geriatric Assessment (CGA) was performed at baseline. We analyzed the associations between factors at baseline (geriatric and oncologic factors) and the need to perform more than three geriatric interventions. The mean age of the population was 82 years old with 59% of patients aged older than 80 years old. A total of 8819 geriatric interventions were implemented for the 3140 patients. The percentage of patients with three or more geriatric interventions represented 31.8% (n = 999) of the population. In multivariate analyses, a Mini Nutritional assessment (MNA) <17, an MNA ≤23·5 and ≥17, a performans status (PS) >2, a dependence on Instrumental Activities of Daily Living (IADL), a Geriatric Depression Scale (GDS) ≥5, a Mini Mental State Examination (MMSE) <24, and a Screening tool G8 ≤14 were independent risk factors associated with more geriatric interventions. Factors associated with more geriatric interventions could assist practitioners in selecting patients for specific geriatric follow-up.

Enterobacteria vaginal colonization among patients with preterm premature rupture of membranes from 24 to 34 weeks of gestation and neonatal infection risk.

AIM: Premature rupture of membranes (PROM) increases the neonatal morbidity and mortality, because of its association with a high risk of prematurity and infection. The group B streptococcus (GBS) prophylaxis using amoxicillin doesn't seem to be adapted to the emergence of new bacteria found in vaginal samples (VS). Our study aim was to assess, for PROM occurring at 23-34 weeks' gestation (WG), if the presence of ampicillin-resistant enterobacteria in the vaginal microbiome is predictive of an increased risk of early-onset neonatal infection. MATERIAL AND METHODS: We conducted a prospective, observational, single-center study at the Nice Academic Hospital (level 3 maternity ward), between March 16, 2014 and May 3, 2015, that evaluated patients with preterm PROM (24-34 WG). Two groups were constituted according to the VS bacteria isolates and the amoxycillin-resistant enterobacteria found. Two groups of newborns were constituted depending on the suspicion of perinatal maternal-fetal bacterial infection (MFI). An intent-to-treat analysis was performed. RESULTS: Among the 67 patients included, 12 newborns presented a strong MFI suspicion, 83% of which were associated to the group of patients with untreated or amoxycillin-resistant enterobacteria VS isolates. CONCLUSION: Our study showed that vaginal colonization of untreated or amoxycillin-resistant enterobacteria constitutes a major risk factor of neonatal infection.

Predicting early death in older adults with cancer.

BACKGROUND: Predicting early death after a comprehensive geriatric assessment (CGA) is very difficult in clinical practice. The aim of this study was to develop a scoring system to estimate risk of death at 100 days in elderly cancer patients to assist the therapeutic decision. METHODS: This was a multicentric, prospective cohort study approved by an ethics committee. Elderly cancer patients aged older than 70 years were enrolled before the final therapeutic decision. A standardised CGA was made before the treatment decision at baseline. Within 100 days, event (death), oncologic and geriatric data were collected. Multivariate logistic regression was used to select the risk factors for the overall population. Score points were assigned to each risk factor using the ß coefficient. Internal validation was performed by a bootstrap method. Calibration was assessed with the Hosmer-Lemeshow goodness of fit test and accuracy with the mean c-statistic. FINDINGS: One thousand fifty patients (mean age: 82 years) joined the study from April 2012 to December 2014. The independent predictors were metastatic cancers (odds ratio [OR] 2.5; 95% confidence interval [CI], [1.7-3.5] p<0 .001); gait speed<0.8 m/s (OR 2.1; 95% CI [1.3-3.3] p=0.001); Mini Nutritional Assessment (MNA) < 17 (OR 8; 95% CI; [3.7-17.3] p<0.001), MNA ≤23.5 and ≥ 17 (OR 4.4; 95% CI, [2.1-9.1) p<0.001); performance status (PS) > 2 (OR 1.7; 95% CI, [1.1-2.6)] p=0.015) and cancers other than breast cancer (OR 4; 95% CI, [2.1-7.9] p<0.001). We attributed 4 points for MNA<17, 3 points for MNA between ≤23.5 and ≥ 17, 2 points for metastatic cancers, 1 point for gait speed <0.8 m/s, 1 point for PS > 2 and 3 points for cancers other than breast cancer. The risk of death at 100 days was 4% for 0 to 6 points, 24% for 7 to 8 points, 39% for 9 to 10 points and 67% for 11 points. INTERPRETATION: To our knowledge, this is the first score which estimates early death in elderly cancer patients. The system could assist in the treatment decision for elderly cancer patients.

[Unexpected focal bowel 18-FDG uptake sites: should they be systematically investigated?]. / Hyperfixations intestinales focales de découverte fortuite sur la TEP au 18-FDG : faut-il proposer une exploration de façon systématique ?

The purpose of the present study was to retrospectively evaluate the nature and significance of unexpected focal 18-FDG uptake localized by PET/CT within the intestinal tract. Methods. The data of 4,033 PET/CT were retrospectively reviewed. One hundred and eighty PET/CT showed unexpected focal uptakes (patients with known intestinal neoplasia were excluded). Among them, 42 patients corresponding to 47 focal uptake sites were investigated by endoscopy or surgery. Results. Height endoscopy results were negative (17%). We found 25 adenomatous polyps (53.2%), 10 neoplasms (21.3%) and 4 inflammatory lesions (8.5%). 18-FDG uptake values were not statistically different between the 4 groups. Conclusion. Eighty-three percent of unexpected intestinal foci of hypermetabolism are either inflammatory, malignant or premalignant lesions. These results justify systematic investigation of these lesions.