Critical norepinephrine dose to predict early mortality during circulatory shock in intensive care: a retrospective study in 3423 ICU patients over 4-year period.

INTRODUCTION: The maximal norepinephrine (NE) dose >1 µg/kg/min during circulatory shock apparently is associated with higher mortality, but this threshold needs confirmation. This study aimed at investigating whether NE infusion at a dose >1 µg/kg/min could predict early intensive care unit (ICU) mortality (first 5 days). The secondary objective was to assess the day-by-day relationship between NE dose during the first four days of ICU stay and subsequent mortality. METHODS: We conducted a retrospective analysis of data from ICU patients receiving NE for circulatory shock at the Nimes University Hospital (France) from January/2016 to December/2019. RESULTS: 5,735 patients were admitted, 3,693 were screened and 3,423 were analyzed. NE infusion at a dose >1 µg/kg/min was associated with day-5 mortality (Hazard Ratio: 7.40, p < 0.0001). The area under the receiver operating characteristic was 0.79 to predict day-5 mortality in ICU for maximal NE > 1 µg/kg/min. The calculated threshold of 1.13 µg/kg/min for maximal NE was the best prognostic value (Sensitivity: 67%, Specificity: 80%, positive predictive value: 45%). When the 1.2 µg/kg/min threshold was crossed either on the first, second, third or fourth day of ICU stay, the probability of subsequent death was 47%, 49%, 60% and 40%, respectively. Along the first four days of ICU stay, the risk of death increased with increasing NE infusion dose. CONCLUSIONS: A NE infusion rate > 1.13 µg/kg/min predicts day-5 mortality in ICU patients with circulatory shock. The time to reach maximal NE infusion rate was shorter in survivors than in non-survivors.

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.

Diagnosis challenges in inception cohorts in axial spondyloarthritis: the case of the French national DESIR cohort.

BACKGROUND: Inception cohorts aim to describe chronic diseases from diagnosis and over years of follow-up. Axial spondyloarthritis (axSpA) diagnosis might be challenging during the first years of the disease. Thus, identifying the features that will be associated with a confirmed diagnosis over time is key. OBJECTIVES: To assess the frequency and the predisposing factors for a change of an initial diagnosis in an inception axSpA cohort. METHODS: DESIR is an ongoing national multicentre inception axSpA cohort with currently 12.5 years of follow-up. At the entry visit and confirmed at each visit, the diagnosis of axSpA was based on the opinion of the treating rheumatologist. Follow-up was interrupted in case of a change in this initial diagnosis. Multiple imputation was used to estimate the probability of a change in the initial diagnosis of axSpA for each patient lost to follow-up. Factors predisposing to an unchanged diagnosis of axSpA were then assessed using a multivariate logistic regression model on the imputed data sets. RESULTS: Of the 708 patients included, over 10 years of follow-up, 45 (6.4%) were excluded due to a diagnosis change and 300 (42.4%) patients were lost to follow-up. Based on the imputation of these 300 patients, a change in their initial axSpA diagnosis was estimated in 42 (14.0%). Factors predisposing to an unchanged initial axSpA diagnosis during follow-up were (ORs (95% CIs)): radiographic sacroiliitis: 17.0 (4.1 to 71.0); psoriasis: 5.3 (2.0 to 14.3); CRP≥6 mg/L: 2.7 (1.3 to 5.3); good NSAID response: 2.5 (1.5 to 4.2); HLA B27+: 2.0 (1.3 to 3.3); anterior chest wall pain: 2.0 (1.2 to 3.3) and female sex: 1.9 (1.2 to 3.0). CONCLUSION: These data suggest that a change in diagnosis in recent onset axSpA exists, but is not frequent, and is less likely to occur in the presence of objective features at baseline.

Prevalence of HIV, Hepatitis C and Hepatitis B Infection Among Detainees in a French Administrative Detention Centre.

BACKGROUND: In France, migrants constitute a significant proportion of people diagnosed with HIV, hepatitis C (HCV) and B (HBV). This study estimated the prevalence of these three viruses among detainees at a French administrative detention centre (CRA), through systematic Rapid Diagnostic Test (RDT) screening. METHODS: This prospective, single-centre, cross-sectional, pilot study included detainees at the Nîmes CRA from February to December 2022. The primary endpoint was HIV, HCV and HBV prevalence determined by RDT. Secondary outcomes were: co-infections; study acceptability, reasons for non-inclusion, causes of non-contributory samples; and concordance between serological tests and RDT. RESULTS: Among the 350 people agreeing to participate of 726 eligible, five refused the RDT, leaving 345 analysable participants for a participation rate of 47.5% (345/726). Participants were predominantly male (90%) with an average age of 31 years. The most common country of origin was Algeria (34%). Twenty (6%) had taken drugs intravenously and 240 (70%) had had unprotected sex within a median of 4.92 [1.08; 15] months. Virus prevalence was: 0% HIV; 4.64 [2.42; 6.86] % HCV; and 2.32 [1.01; 4.52] % HBV. Eleven (73%) of the RDT HCV positive cases were confirmed serologically. RDT detected one false-positive HCV case, as an anti-HCV Ac serological test was negative. Of the eight patients with positive HBV RDT, one declined the serology testing, thus 100% (7/7) of the tested RDT positive cases were confirmed by serology. CONCLUSION: The study highlighted the need to screen detainees for HIV, HCV and HBV infection and suitability of RDTs.

The value of ultrasound-guidance of nerves and muscles for patient tolerance and parameters electrodiagnostic studies.

Objective: To assess impact of ultrasound guidance (USG) on patient's perception of nerve conduction studies (NCS). Methods: In this single-center, randomized, sham-controlled, parallel, single-blind trial, we evaluated ultrasound (US) in identifying NCS stimulation site. Consecutive adults (18-80 old) without neuropathy referred for NCS were electronically randomized 1:1 to USG or Sham US. The primary outcome was sensory supramaximal intensity (SSMI) for each site/nerve; motor supramaximal intensity (MSMI), amplitudes, number of non-routine muscle punctured, Visual Analogue Scale (VAS), satisfaction were secondary outcomes. Results: 290 participants were randomized, with 145 in the USG and 144 Sham US groups, respectively. No difference in SSMI, CMAP or SNAP, VAS, satisfaction was recorded. With USG, the median at the elbow and fibular MMSI were lower (p = 0.04; p = 0.02). With normal NCS or overweight and obese subgroups patients had lower median SSMI (p = 0.05/ p = 0.02), higher median and sural SNAP with normal NCS (p = 0.04; p = 0.007) and the sural SNAP for the expert US subgroup (p = 0.02). Conclusions: USG is useful for nerves, that are anatomically variable or in obesity. The sural SNAP gain with US in the normal NCS subgroup could facilitate routine NCS. Significance: In standard NCS the USG does not modify the patient's tolerance.Trial Registration: clinicaltrials.gov (NCT03868189).

Dementia and glaucoma: Results from a Nationwide French Study between 2006 and 2018.

PURPOSE: Glaucoma is the leading cause of irreversible blindness worldwide. The brain and eye share many characteristics, so the eye may provide an easy-access window on brain processes. The aim of the study was to evaluate the link between glaucoma as well as intraocular pressure (IOP)-lowering drops load and all-cause dementia. METHODS: This was a nested case-control study based on the French national healthcare database from 1 January 2006 to 31 December 2018in individuals aged ≥60 years. We compared cases of incident all-cause dementia with 1:5 controls matched by date of case diagnosis (index date), age, sex, and income. We set a 5-year exposure to glaucoma period ending 2 years before the index date (lag-time period to avoid protopathic bias). The main outcome was glaucoma defined with hospitalization related to POAG and/or dispensations of IOP-lowering drops. The secondary outcome was the IOP-lowering drops load. RESULTS: In total, 4810 incident all-cause dementia and 24 050 matched controls were analysed (median [IQR] age 82 [10] years; 66.6% women). The prevalence of glaucoma was 14.0% in controls and cases. Risk of all-cause dementia was not associated with glaucoma (crude OR, 1.02; 95% CI [0.93-1.11]; p = 0.7; adjusted OR, 0.99; 95% CI [0.91-1.09]; p = 0.9) or IOP-lowering drops load (p = 0.2). CONCLUSION: The present study in general population ≥60 years old in France did not find any association between glaucoma and incident all-cause dementia.

Ten-year clinical outcome of recent-onset axial spondyloarthritis: Results from the DESIR inception Cohort.

OBJECTIVES: This study aimed to evaluate the 10-year clinical outcome of patients with recent-onset axial spondyloarthritis (axSpA). METHODS STUDY DESIGN: The DESIR cohort is an inception cohort of axSpA patients. METHODS DIAGNOSIS AND MANAGEMENT: The diagnosis and management of patients were based on the decision of the treating rheumatologist. METHODS STATISTICAL ANALYSIS: Both complete cases and imputed data analyses were conducted. RESULTS: Of the 708 enrolled patients, 45 were excluded due to a change in the baseline diagnosis, 3 patients died, and 300 were lost to follow-up over the 10years. In the completer population, one patient required bilateral total hip replacement, and 56 patients received a pension due to invalidity. The prevalence of main extra-musculoskeletal features increased from baseline to year 10: psoriasis from 18% to 30%, acute anterior uveitis from 10% to 18%, and inflammatory bowel disease from 5% to 10%. The most frequent comorbidity was hypertension, with an increase from 5% to 15% from baseline to year 10. In the imputed data analysis the estimated proportions of patients with an acceptable status at year 10 were 70% [95% CI: 63; 77] for acceptable PASS, 43% [95% CI: 37; 49] for BASDAI<3, and 48% [95% CI: 41; 56] for ASDAS<2.1. CONCLUSION: These findings suggest that despite a quite favorable 10-year outcome exists for severe outcomes, a large proportion of patients present with an important disease burden reflected by patient-reported outcomes. This information can be valuable for providing patients with information at the time of diagnosis.

Cross-Calibration Study of The Stratos And Hologic QDR 4500A Dual-Energy X-Ray Absorptiometers to Assess Bone Mineral Density And Body Composition.

The objective of the study was to assess the agreement between the Stratos (DMS) and QDR 4500A (Hologic) DXAs in determining whole body and regional aBMD, as well as whole body composition. Fifty-five individuals (46 women: 84%) with a mean age of 41 ± 13.0 years (range: 20 to 64) and a mean BMI of 31.9 ± 10 kg/m² (range: 12.2 to 49.5) were consecutively scanned on the same day using the two devices. Predictive equations for areal bone mineral density (aBMD) and whole body composition (WBC) were derived from linear regression of the data. The two DXAs were highly correlated (p<0.001 for all parameters) with a correlation coefficient (r) ranging from 0.89 to 0.99 for aBMD (r=0.89 for whole body, r=0.92 for radius, r=0.95 for femoral neck, r=0.96 for total hip, and r=0.99 for L1-L4). For WBC, the r value was 0.98 for lean tissue mass (LTM) and 1.0 for fat mass (FM). Paired t-tests indicated a statistically significant bias between the two DXAs for the majority of measurements, requiring the determination of specific cross-calibration equations. Compared to QDR 4500A, Stratos underestimated whole body aBMD and LTM and overestimated neck and hip aBMD and whole body FM. Conversely, no significant bias was demonstrated for mean aBMD at L1-L4 and radius. For whole body aBMD and FM, the concordance between the two DXAs was influenced by BMI. Despite a high concordance between the two DXAs, the systematic bias for aBMD and WBC measurements illustrates the need to define cross-calibration equations to compare data across systems.

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.

Violence against nurses in the emergency department: an observational study.

OBJECTIVE: This study aimed to evaluate the number and risk factors of violent events encountered in the emergency department. An observation grid was developed following interviews with emergency department staff to target the most pertinent information to collect in a prospective study design. DESIGN: Observational study. SETTING: Emergency department of a tertiary hospital in France. OUTCOME MEASURES: Number of violent events occurring during a single shift, recorded over 6 months by two observers. Information collected included time and date of incident; number of male/female staff; number of patients and accompaniers present in the service and the waiting room and length of staff debriefing. Perpetrator, victim and patient information were collected. Victims were followed-up 72 hours later. RESULTS: Eighty-two periods were observed between November 2015 and April 2016 recording 35 violent incidents affecting 37 perpetrators and 48 victims, equally distributed over the days of the week and months of the year. The median interval until violence was 0 [0-96] min from entry. Eight (23%) events were officially reported, with two (6%) resulting in charges being pressed. No risk factors were significantly associated with violent incidents in multivariate analysis, although there was a tendency towards significance for fewer senior female doctors present (p=0.0787) and a resulting longer debriefing session (p=0.0712). CONCLUSIONS: We confirm the high rate of violence in the emergency department and poor level of official reporting. Strategies should be implemented to anticipate and reduce incidence and encourage reporting by affected staff. TRIAL REGISTRATION NUMBER: NCT02116439.

S100B serum level: A relevant biomarker for the management of non-traumatic headaches in emergency care?

BACKGROUND: The diagnostic of primary or secondary headaches in emergency units is mostly based on brain imaging, which is expensive and sometimes hardly accessible. An increase in serum S100B protein has already been found in several neurological conditions inducing brain damage. The objective of this study was to assess the diagnostic performance of S100B serum assay to distinguish primary and secondary headaches among patients with non-traumatic headaches in the emergency department. METHODS: This was a phase 2, prospective, monocentric diagnostic study. Eighty-one adult patients with non-traumatic headaches in the emergency department were included. In addition to the usual management, a blood assay of the S100B protein was performed in the emergency department, as well as a brain MRI between 48 and 96 h if not performed during the initial management. The primary or secondary headache diagnosis was made at one month by an expert committee, blindly of the results of the S100B assay. The primary outcome was the blood assay of the S100B protein. RESULTS: There was 63 patients for analysis in the primary headache group and 17 in the secondary headache group. The S100B protein assay was significantly higher in secondary headaches than primary headaches, with an AUC of the ROC curve of 0.67. The optimal threshold of 0.06 µg.L-1 allowed to obtain those diagnostic characteristics: sensitivity 75% [48; 93], specificity 62% [48; 74], PPV 35% [20; 54] and NPV 90% [76; 97]. The association between the S100B protein level and the onset of pain was significantly higher for patients with headaches <3 h. CONCLUSION: The assay of the S100B protein could be useful in the management of this pathology in emergencies. Future studies taking into account dosing time and etiologies could be conducted in order to refine its use in practice.

Association between brain metabolism and clinical course of motor functional neurological disorders.

Features of resting brain metabolism in motor functional neurological disorder are poorly characterized. This study aimed to investigate the alterations of resting brain metabolism in a cohort of patients experiencing a first episode of motor functional neurological disorder with recent symptom onset and their association with persistent disability after 3 months. Patients eligible for inclusion were diagnosed with first episode of motor functional neurological disorder, were free from bipolar disorder, substance use disorder, schizophrenia, psychogenic non-epileptic seizure or any chronic or acute organic neurological disorder. Exclusion criteria included current suicidal ideation, antipsychotic intake and previous history of functional neurological disorder. Nineteen patients were recruited in Psychiatry and Neurology departments from two hospitals. Resting brain metabolism measured with 18F-fluorodeoxyglucose positron emission computed tomography at baseline and 3 months was compared to 23 controls without neurological impairment. Disability was scored using Expanded Disability Status Scale and National Institutes of Health Stroke Scale score at baseline and 3 months. Correlations were calculated with Spearman correlation coefficient. Hypometabolism was found at baseline in bilateral frontal regions in patients versus controls, disappearing by 3 months. The patients with Expanded Disability Status Scale score improvement showed greater resting state activity of prefrontal dorsolateral cortex, right orbito-frontal cortex and bilateral frontopolar metabolism at 3 months versus other patients. The resting state metabolism of the right subgenual anterior cingular cortex at baseline was negatively correlated with improvement of motor disability (measured with Expanded Disability Status Scale) between inclusion and 3 months (r = -0.75, P = 0.0018) and with change in motor symptoms assessed with the National Institutes of Health Stroke Scale (r = -0.81, P = 0.0005). The resting state metabolism of the left subgenual anterior cingular cortex at baseline was negatively correlated with improvement in Expanded Disability Status Scale and National Institutes of Health Stroke Scale scores between inclusion and 3 months (r = -0.65, P = 0.01 and r = -0.75, P = 0.0021, respectively). The negative association between the brain metabolism of the right subgenual anterior cingular cortex at baseline and change in National Institutes of Health Stroke Scale score remained significant (r = -0.81, P = 0.0414) after correction for multiple comparisons. Our findings suggest the existence of metabolic 'state markers' associated with motor disability and that brain markers are associated with motor recovery in functional neurological disorder patients.

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.

Comparison of interface pressures in two dynamic pressure ulcer prevention supports (NIMBUS 3 and SUMMIT): A randomized controlled trial.

BACKGROUND: Pressure ulcers are a risk for bedridden patients and various supports exist to prevent them. The Pressure Relief Index (PRI) evaluates pressure relief of dynamic mattresses over time. This study compared the PRI of the SUMMIT mattress (AKS-France) and the NIMBUS 3 (HNE Medical). METHODS: In this non-blinded, randomized, crossover, non-inferiority study, patients aged ≥60 with a BMI of 16-35 kg/m2, predominantly confined to bed, able to walk with aid and with pelvic symmetry were recruited from a hospital rehabilitation department from March-April 2012. Exclusion criteria included past or present pressure ulcers, inability to remain supine and deep vein thrombosis. Peak pressures of the sacrum were recorded at 0.1 Hz during a single complete 10-min inflating cycle on both mattresses, with the order determined via electronic randomization allocation. RESULTS: Thirty-one subjects were included and randomized; with 14 finally analyzed in the SUMMIT-NIBMUS 3 order group and 16 in the NIMBUS 3-SUMMIT group. The difference in PRI <30 mmHg between the two mattresses was 13.2% [0.3-26.1] (p < 0.05), allowing a non-inferiority - superiority switch. The SUMMIT mattress demonstrated a significantly higher percentage of time <30 mmHg (p = 0.0454). No significant difference in mean minimal pressure was seen (p = 0.3231) and mean maximal pressure was in favor of SUMMIT mattress (p = 0.0096). BMI did not affect pressure profile. There were no adverse events. CONCLUSIONS: Evaluated by the PRI, the SUMMIT mattress had a better interface pressure profile than the NIMBUS 3 in older patients. The PRI is a promising tool for clinical decision-making and research, warranting validation.

Evaluation of the effect of multipoint intra-mucosal vaginal injection of a specific cross-linked hyaluronic acid for vulvovaginal atrophy: a prospective bi-centric pilot study.

BACKGROUND: Vulvo-vaginal atrophy (VVA) is one of the common consequences of estrogen deficiency especially after the menopause. Several studies have assessed the effects of Hyaluronic acid (HA) on physical and sexual symptoms associated with VVA with promising results. However, most of these studies have focused on subjective assessment of symptom response to topically administered preparations. Nonetheless, HA is an endogenous molecule and it is logical that its effects are best realized if injected in the superficial epithelial layers. Desirial® is the first crosslinked HA that is administered by injection in the vaginal mucosa. The aim of this study was to explore the effect of multipoint vaginal intra-mucosal injections of specific cross-linked hyaluronic acid (DESIRIAL®, Laboratoires VIVACY) on several clinical and patient reported core outcomes. METHODS: A cohort bi-centric pilot study. The chosen outcomes included change in vaginal mucosa thickness, biological markers for collagen formation, vaginal flora, vaginal pH, vaginal health index, vulvo-vaginal atrophy symptoms and sexual function 8 weeks post Desirial® injection. Patients' satisfaction was also assessed using the patient global impression of improvement (PGI-I) scale. RESULTS: A total of 20 participants were recruited between 19/06/2017 and 05/07/2018. At the end of the study, there was no difference in the median total thickness of the vaginal mucosa or in procollagen I, III or Ki67 fluorescence. However, there was a statistically significant increase in COL1A1 and COL3A1 gene expression (p = 0.0002 and p = 0.0010 respectively). There was also a significant reduction in reported dyspareunia, vaginal dryness, vulvar pruritus, vaginal chafing and significant improvement in all female sexual function index dimensions. Based on PGI-I, 19 patients (95%) reported varying degrees of improvement where, 4 (20%) felt slightly better; 7 (35%) better and 8 (40%) much better. CONCLUSIONS: Multi-point vaginal intra-mucosal injections, of Desirial® (a crosslinked HA) was significantly associated with the expression of CoL1A1 and CoL3A1 suggesting stimulation of collagen formation. Furthermore, there was a significant reduction in VVA symptomatology and a significant improvement in patient satisfaction and sexual function scores. However, there was no demonstrable change in the total vaginal mucosal thickness. Study registration ID-RCB: 2016-A00124-47, Protocol code number: LOCAL/2016/PM-001.

French validation of the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire-IUGA revised (PISQ-IR).

INTRODUCTION AND HYPOTHESIS: The aim of this study was to clinically validate the French-translated PISQ-IR in a French-speaking population of women with pelvic floor disorders. METHODS: We aimed to recruit 300 women to account for potential attrition secondary to failure to respond or loss to follow-up. Women were enrolled as part of an RCT and from a separate specific study. Both studies included surgically managed patients. Data were collected at recruitment, visit 1 (V1), V2 (9-12 months postoperatively) and V3 (V2 + 5-15 days). Participants also completed a PFDI 20, ICI-Q and FSFI and were assessed by POP-Q. RESULTS: A total of 297 women were recruited between 18 January 2013 and 18 January 2016. Data were available for 291, 148 and 110 participants at V1, V2 and V3, respectively. The non-response rate for the NSA items varied from 5% to 30%, while for SA women, the non-response rate for the items varied from 0% to 15%. The tool was deemed reliable for five domains of the summary score. We also identified that several sections demonstrated acceptable to good temporal stability. A statistically significant score change was identified in different domains in the participants categorized as improved on either PGI-I or POP-Q. We also identified moderate to strong correlations between PISQ-IR and FSFI. CONCLUSIONS: The French translated PISQ-IR has several strengths in support of its validity. Our findings confirm the validity of the summary scores in addition to the item-based initial scoring system.

Post-operative opioid-related adverse events with intravenous oxycodone compared to morphine: A randomized controlled trial.

BACKGROUND: The value of intravenous oxycodone compared to morphine remains controversial. The purpose of this trial was to compare opioid-related adverse events (ORAES) of intravenous oxycodone and morphine after total hip arthroplasty. METHODS: Patients scheduled for total hip arthroplasty were enrolled in this study of post-operative pain treatment with intravenous oxycodone or intravenous morphine (ratio 1:1). After surgery, patients received similar drug regimens for titration in the post-operative care unit followed by intravenous patient-controlled analgesia (PCA). The primary outcome was the number of patients with ≥1 ORAEs within the first 24 hours defined as either nausea, vomiting, respiratory depression, pruritus, urinary retention requiring evacuation, allergy, hallucinations. Secondary outcomes included pain scores and opioid consumption. RESULTS: The analysis included 238 patients with similar characteristics. There were 55 patients with at least one ORAEs in the oxycodone group vs 46 in the morphine group: 48% vs 40%, P = .19; relative risk = 1.22 (0.91:1.63). Intravenous oxycodone vs intravenous morphine requirements were respectively (median, IQR): 6 (0-11) vs 8 (0-12) mg (P = .06) for titration, 15 (8-26) vs 8 (5-16) mg (P = .001) for PCA, and 22 (12-37) mg vs 19 (11-28) mg for cumulated intravenous consumption (P = .048). During the first 24 hours, there was no difference in secondary outcomes (oxycodone vs morphine, respectively, in %): nausea (15 vs 13), vomiting (5 vs 5), urinary retention (20 vs 12) or pain scores. CONCLUSION: This study demonstrates that IV oxycodone did not significantly reduce ORAEs within the first 24 hours compared to similar ratio of IV morphine.

Unilateral versus bilateral sacral neuromodulation test in the treatment of refractory idiopathic overactive bladder: A randomized controlled pilot trial.

AIM: To compare treatment success rate in terms of improvement of bladder overactivity between unilateral and bilateral sacral neuromodulation testing. METHODS: A multicentric, parallel, randomized, open pilot trial (October 2012-September 2017) was conducted. Participants presented primary overactive bladder resistant to first-line treatments. Patients were excluded in case of secondary bladder, pelvic, or neurological condition. Patients were randomized between bilateral testing (n = 28) or unilateral testing (n = 27), to determine the best functional response before final implantation. The primary outcome was the rate of patients presenting at least 50% of clinical improvement at 1 month on urinary frequency, number of urge incontinence episodes or number of urinary urgency episodes. Symptom severity, implantation success rate, uroflowmetry, device tolerance, complications, and quality of life were also assessed. RESULTS: Fifty-five patients have been included. The rate of patients presenting at least one significant clinical improvement at month 1 was 62% in the bilateral group versus 84% in the unilateral group (P = .0891), RR = 0.74 (0.51; 1.07). There was no significant difference between bilateral and unilateral groups in terms of improvement of urinary frequency (0% and 17%; P = .1115), number of urge incontinence episodes (52% and 63%; P = .4929) or number of urinary urgency episodes (57% and 74%; P = .2411). More complications were reported in the bilateral group than in the unilateral group (9 [47%] vs 4 [16%], respectively; P = .0239). CONCLUSION: Systematic bilateral sacral neuromodulation testing before final implantation did not appear to increase success rate compared with unilateral stimulation in the treatment of overactive bladder.

Long-term outcomes of a randomized controlled trial comparing trans-obturator vaginal mesh with native tissue repair in the treatment of anterior vaginal wall prolapse.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to report the long-term subjective and objective outcomes after transvaginal mesh (TVM) or native tissue repair. METHODS: Prospective, randomized, multicenter study conducted between April 2005 and December 2009 comparing anterior colporrhaphy with trans-obturator vaginal mesh (Pelvitex/Ugytex®, Sofradim, Trevoux, France) for the treatment of anterior vaginal wall prolapse. The primary endpoint was functional recurrence rate 5-8 years after surgery. Secondary endpoints consisted of anatomical results, mesh-related morbidity and patient satisfaction measured through validated questionnaires. RESULTS: Of the 147 women originally included, 75 (51%) were successfully re-contacted a median of 7 years after the initial surgery. The primary outcome, subjective recurrence of prolapse, was similar between the TVM and the anterior colporrhaphy groups (31 vs 34% respectively). Anatomical recurrence was less likely in the TVM group (67 vs 24%, p = 0.004). Mesh exposure occurred in 4 of the 39 patients (13%) during follow-up, 2 of which had a surgical reintervention. Reintervention for prolapse took place in 7 patients (9%). CONCLUSION: Seven-year follow-up showed similar functional outcomes for mesh and native tissue repair in anterior vaginal wall prolapse. TVM did not reduce repeat surgery in the long term; it did, however, reduce anatomical recurrence. Mesh exposure rates were relatively high, but no difference in outcome of pain or dyspareunia was noted.

Inertial measurement unit compared to an optical motion capturing system in post-stroke individuals with foot-drop syndrome.

BACKGROUND: Functional electrical stimulation (FES) can be used for compensation of foot-drop for post-stroke individuals by pre-programmed fixed stimulation; however, this stimulation seems no more effective than mechanical ankle foot orthoses. OBJECTIVE: We evaluated the metrological quality of inertial sensors for movement reconstruction as compared with the gold-standard motion capturing system, to couple FES with inertial sensors to improve dorsiflexion on the paretic side, by using an adaptive stimulation taking into account individuals' performance post-stroke. METHODS: Adults with ischemic or hemorrhagic stroke presenting foot-drop and able to walk 10m, were included from May 2016 to June 2017. Those with passive ankle dorsiflexion<0° with the knee stretched were excluded. Synchronous gait was analyzed with the VICON© system as the gold standard and inertial measurement units (IMUs) worn by participants. The main outcome was the dorsiflexion angle at the heel strike and mid-swing phase obtained from IMUs and the VICON system. Secondary outcomes were: stride length, walking speed, maximal ankle dorsiflexion velocity and fatigue detection. RESULTS: We included 26 participants [18 males; mean age 58 (range 45-84) years]. During heel strike, the dorsiflexion angle measurements demonstrated a root mean square error (RMSE) of 5.5°; a mean average error (MAE) of 3.9°; Bland-Altman bias of -0.1° with limits of agreement -10.9° to+10.7° and good intra-class correlation coefficient (ICC) at 0.87 between the 2 techniques. During the mid-swing phase, the RMSE was 5.6; MAE 3.7°; Bland-Altman bias -0.9° with limits of agreement -11.7° to+9.8° and ICC 0.88. Good agreement was demonstrated for secondary outcomes and fatigue detection. CONCLUSIONS: IMU-based reconstruction algorithms were effective in measuring ankle dorsiflexion with small biases and good ICCs in adults with ischemic or hemorrhagic stroke presenting foot-drop. The precision obtained is sufficient to observe the fatigue influence on the dorsiflexion and therefore to use IMUs to adapt FES.