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.

Impact of kidney transplantation in obese candidates: a time-dependent propensity score matching study.

BACKGROUND: Although kidney transplantation (KT) is considered the best treatment for end-stage renal disease (ESRD), there are concerns about its benefit in the obese population because of the increased incidence of post-transplant adverse events. We compared patients who underwent KT versus patients awaiting KT on dialysis. METHODS: We estimated the life expectancy [restricted mean survival time (RMST)] for a 10-year follow-up by matching on time-dependent propensity scores. The primary outcome was time to death. RESULTS: In patients with a body mass index (BMI) ≥30 kg/m2 (n = 2155 patients per arm), the RMST was 8.23 years [95% confidence interval (CI) 8.05-8.40] in the KT group versus 8.00 years (95% CI 7.82-8.18) in the awaiting KT group, a difference of 2.71 months (95% CI -0.19-5.63). In patients with a BMI ≥35 kg/m2 (n = 212 patients per arm), we reported no significant difference [8.56 years (95% CI 7.96-9.08) versus 8.66 (95% CI 8.10-9.17)]. Hence we deduced that KT in patients with a BMI between 30 and 35 kg/m2 was beneficial in terms of life expectancy. CONCLUSION: Regarding the organ shortage, KT may be questionable for those with a BMI ≥35 kg/m2. These results do not mean that a BMI ≥35 kg/m2 should be a barrier to KT, but it should be accounted for in allocation systems to better assign grafts and maximize the overall life expectancy of ESRD patients.

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.

How is the minimal clinically important difference established in health-related quality of life instruments? Review of anchors and methods.

BACKGROUND: The aim of this systematic review is to describe the different types of anchors and statistical methods used in estimating the Minimal Clinically Important Difference (MCID) for Health-Related Quality of Life (HRQoL) instruments. METHODS: PubMed and Google scholar were searched for English and French language studies published from 2010 to 2018 using selected keywords. We included original articles (reviews, meta-analysis, commentaries and research letters were not considered) that described anchors and statistical methods used to estimate the MCID in HRQoL instruments. RESULTS: Forty-seven papers satisfied the inclusion criteria. The MCID was estimated for 6 generic and 18 disease-specific instruments. Most studies in our review used anchor-based methods (n = 41), either alone or in combination with distribution-based methods. The most common applied anchors were non-clinical, from the viewpoint of patients. Different statistical methods for anchor-based methods were applied and the Change Difference (CD) was the most used one. Most distributional methods included 0.2 standard deviations (SD), 0.3 SD, 0.5 SD and 1 standard error of measurement (SEM). MCID values were very variable depending on methods applied, and also on clinical context of the study. CONCLUSION: Multiple anchors and methods were applied in the included studies, which lead to different estimations of MCID. Using several methods enables to assess the robustness of the results. This corresponds to a sensitivity analysis of the methods. Close collaboration between statisticians and clinicians is recommended to integrate an agreement regarding the appropriate method to determine MCID for a specific context.

Are ovarian response and pregnancy rates similar in selected FMR1 premutated and mutated patients undergoing preimplantation genetic testing?

PURPOSE: To assess if the ovarian response of FMR1 premutated women undergoing preimplantation genetic testing (PGT) for Fragile X syndrome is lower compared with fully mutated patients, due to their frequent premature ovarian failure. METHODS: In a retrospective cohort study from January 2009 to March 2019, we compared PGT outcomes in 18 FMR1 premutated women and 12 fully mutated women and aimed to identify predictive factors of stimulation outcomes. RESULTS: Eighty-six IVF/PGT-M cycles for FMR1 PGT were analyzed. Premutation and full mutation patients were comparable in terms of age, body mass index (BMI), basal FSH, antral follicular count, and cycle length. However, premutation carriers had significantly lower AMH (1.9 versus 4.0 ng/mL, p = 0.0167). Premutated patients required higher doses of FSH (2740 versus 1944 IU, p = 0.0069) but had similar numbers of metaphase II oocytes (7.1 versus 6.6, p = 0.871) and embryos (5.6 versus 4.9, p = 0. 554). Pregnancy rates (37.1% versus 13.3%, p = 0.1076) were not statistically different in both groups. CONCLUSION: In spite of lower ovarian reserve and thanks to an increased total dose of FSH, FMR1 premutated selected patients seem to have similar ovarian response as fully mutated patients. Neither the number of CGG repeats in FMR1 gene nor FMR1 mutation status was good predictors of the number of retrieved oocytes.

Cost analysis of prostate cancer detection including the prostate health index (phi).

OBJECTIVE: To assess the economic impact of introducing the prostate health index (phi) for prostate cancer (PCa) detection. METHODS: A total of 177 patients who presented in an academic institution with a tPSA between 2 and 10 ng/ml and underwent prostate biopsies within the 3 months were enrolled. With phi and tPSA thresholds of 43 and 4 ng/ml, respectively, probability for each branch of a decision tree model for PCa diagnosis and corresponding mean cost were estimated with "Monte Carlo" simulations. A sensitivity analysis was performed. RESULTS: With a similar sensitivity, phi strategy increased positive predictive value by 13.9 points and negative predictive value by 31.6 points in comparison to tPSA strategy. Mean costs per patient with tPSA and phi strategies were €514 and €528, respectively, for a phi test price at 50€. One-way sensitivity analysis showed that phi strategy was less expensive (508€/patient) than tPSA strategy with a phi test price below 30€. In multi-criteria sensitivity analysis, PPV and the rates of positive phi and tPSA were the parameters with the largest impact on the final cost as opposed to the cost of the biopsy or imaging which have less influence. With an expected rate of positive phi test < 60%, tPSA strategy was more expensive than phi strategy. CONCLUSIONS: The introduction of phi index in PCa detection would result in a significant clinical benefit compared to tPSA strategy. In our economic model, the phi strategy was equivalent or slightly more expensive than the current tPSA strategy.

Impact of mode of delivery of twins on the pelvic floor 3 and 12 months post-partum-part II.

INTRODUCTION AND HYPOTHESIS: To compare the impact of vaginal delivery (VD) versus cesarean section (CS) on the pelvic floor in twin primiparae at 3 and 12 months postpartum. METHODS: This comparative multicenter prospective cohort from a large French national cohort study consisted of primiparas who gave birth to live twins after 34 weeks of gestation. The primary end point was the postnatal urinary incontinence rate 3 months postpartum. The secondary end points were the pelvic floor dysfunction (PFD) at 3 and 12 months based on PFDI-20, PFIQ-7, PISQ-12, and SF-12 responses. RESULTS: A total of 2812 patients in 172 French maternity units were recruited between February 2014 and March 2015: 1076 (38%) responded at 3 and 12 months (61% at 3 months); 1155 were analyzed at 3 months (556 VD and 599 CS) and 800 at 12 months (394 VD and 406 CS). VD was associated with more symptoms at 3 months [median PFDI-20 score 25/300 (8-50) vs. 17/300 (4-36) after CS; p < 0.0001]. Vaginal bulge was more frequently reported after VD (9 vs. 4%; p = 0.0015). Abdnormal PFD-related quality-of-life scores (scores > 0) were more frequent after VD at 3 months (58 vs. 42%; p < 0.0001) and 12 months (57 vs. 43%; p = 0.0020), indicating greater discomfort. However, SF-12 scores were higher after VD [56 (53-59) vs. 55 (51-58)] at 12 months, indicating better general quality of life. CONCLUSIONS: Mode of delivery is significantly associated with pelvic organ prolapse symptoms 3 months postpartum, which regress by 12 months, probably because of the known spontaneous postnatal improvement of PFDs.

Risk of new-onset urinary incontinence 3 and 12 months after vaginal or cesarean delivery of twins: Part I.

INTRODUCTION AND HYPOTHESIS: Our purpose was to compare the prevalence of urinary incontinence (UI) 3 and 12 months after vaginal vs cesarean delivery of twins after 34 weeks of gestation. METHODS: This was a multicenter prospective cohort study conducted at 172 French maternity units and included 2812 primiparous women with twins with no prior history of UI. Participants were enrolled at the time of delivery and followed up to 12 months postpartum. The primary outcome was the prevalence of UI, both stress and urge, 3 months postpartum, based on the patient reporting any frequency of urine leakage to the first question of the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF). The Pelvic Floor Distress Inventory - Short Form 20 (PFDI-20), Pelvic Floor Impact Questionnaire - Short Form 7 (PFIQ-7), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), and Medical Outcome Study Short Form-12 (SF-12) were also used. RESULTS: The ICIQ-SF was completed by 1155 (39.8%) and 800 (27.5%) women, respectively, at 3 and 12 months postpartum; 556 (48%) had delivered vaginally and 599 (52%) by cesarean section. The prevalence of UI at 3 months was 26% overall and was significantly higher in the vaginal delivery group at both 3 months (35% vs 17% in the cesarean group, p < 0.0001) and 12 months postpartum (38% vs 24%, p < 0.0001). UI was predominantly stress or mixed. The risk factors for UI at 3 months, determined by multivariate modeling, were vaginal delivery [odds ratio (OR) 3.073, 95% confidence interval (CI) 2.3-4.105, p < 0.0001) and body mass index >25 in early pregnancy (OR 1.620, 95% CI 1.188-2.209, p = 0.0023). CONCLUSIONS: Vaginal delivery is a risk factor for UI at 3 months after twin birth.

[Nutritional status of residents of a nursing home and optimisation of the working time of caregivers]. / État nutritionnel des résidents en Ehpad et optimisation du temps de travail des soignants.

The lack of time to devote to care is a frequent complaint of nurses and nursing assistants. The results of a study show that an improvement in the nutritional status of nursing home residents could help to improve their quality of life and to optimise the working time of the nursing teams, thanks to the reduction of pressure ulcers, diarrhoea, falls, fractures and infections.

In myotonic dystrophy type 1 reduced FDG-uptake on FDG-PET is most severe in Brodmann area 8.

BACKGROUND: In myotonic dystrophy type 1 (DM1), only one FDG-PET study used statistical parametric mapping (SPM) showing frontal reduced FDG-uptake. Our aim was to 1) identify the FDG-PET area with the most severe reduced FDG-uptake using SPM8 in a larger group of patients 2) assess potential correlation between CTG-numbers and FDG-PET. METHODS: FDG-PET was performed in 24 patients and compared to 24 controls. Pearson's correlation was used to analyse correlation. RESULTS: SPM8 revealed Brodmann area 8 as the area with the most severe reduced FDG-uptake. Weak, although not statistically significant, correlation was observed between CTG-numbers and reduced FDG-uptake in Brodmann area 8. CONCLUSION: In DM1, Brodmann area 8 is the area with the most severe reduced FDG-uptake on FDG-PET. Brodmann area 8 reduced FDG-uptake is correlated -although weakly- to CTG-repeat numbers.

Nationwide trends over 10 years in epidemiology and management of pancreatic ductal adenocarcinoma: A real-world study from the French administrative database.

BACKGROUND & AIMS: Significant progress has been made in the management of pancreatic ductal adenocarcinoma (PDAC) in recent years. In this population-based study, we aimed to compare incidence, therapeutic strategies, and survival outcomes of PDAC patients in France over a decade. METHODS: This study was performed using a nationwide French database. All patients receiving care for PDAC during years 2009, 2014 and 2018 were included. Treatment modalities and survival outcomes were analyzed. RESULTS: A total of 8143/8771/10494 patients were considered in 2009/2014/2018, respectively. Incidence increased mainly among patients aged >60 years. In localized PDAC, the proportion of patients receiving best supportive care (BSC) only decreased at 43.6/36.4/32.4 % and 27.8/29.1/34.3 % received chemo(radio)therapy alone. The rate of upfront surgery remained stable while 3/8/18 % of operated patients received neoadjuvant therapy. Median overall survival (OS) was 7.0/7.9/8.5 months in the overall population. Among treated patients, 1-year OS was 61.4/67.7/68.8 % and 30.3/36.3/38.8 % for localized and metastatic PDAC, respectively. CONCLUSIONS: This study confirms the rising incidence of PDAC. Improved outcomes were seen in localized PDAC, with a wider use of chemotherapy and neoadjuvant strategies, and in treated metastatic patients. A modest survival gain was seen overall, hindered by the still high rate of patients receiving BSC only.

Nitrous oxide provided during intensive physiotherapy for shoulder adhesive capsulitis does not improve function: A randomised controlled trial.

BACKGROUND: There is no consensus on treatment for adhesive capsulitis of the shoulder. Physiotherapy is often used to increase range of motion but individuals may experience pain during mobilisation. OBJECTIVES: The objective of this study was to determine whether rehabilitation under N2O for shoulder AC improved pain and function more than rehabilitation alone (with placebo gas). METHOD: A randomised, 1:1 parallel arm, double-blind study in 4 university hospital outpatient centres. Adults with adhesive capsulitis for at least 3 months with intact cartilage were included. Participants were randomised in blocks of 4 and stratified by centre to receive 20 sessions of intensive physiotherapy over 10 days; the 10 morning sessions were performed with either nitrous oxide (intervention) or sham gas (placebo). PRIMARY OUTCOME: improvement in shoulder function at day 14 (D14) (Constant-Murley score). RESULTS: Seventy-five participants were included, and data from 69 were analysed: 37 in the placebo group and 32 in the intervention group. Improvements occurred in both groups after the intervention. No significant difference in the Constant-Murley score was found between groups at D14 (median score increase of 12.0, IQR 5.6; 19.5 points in placebo group vs. 13.7, 5.2; 18.2 in the N20 group, p = 0.78). Pain score during sessions reduced in the intervention group from the first to final session (-11.6, p = 0.053) but not for the placebo group (-4.2, p = 0.414). Seven serious adverse events were recorded, 4 in the intervention group and 3 in the placebo group, with 11 minor adverse events only in the intervention group (mostly shortness of breath). CONCLUSION: Nitrous oxide gas associated with intensive physiotherapy for shoulder adhesive capsulitis did not improve function, pain or quality of life more than physiotherapy alone. zHowever, pain experienced during physiotherapy sessions appeared lower. TRIAL REGISTRATION: Clinical Trial registration number NCT01087229.

Evaluating the costs of adverse drug events in hospitalized patients: a systematic review.

BACKGROUND: Adverse drug events (ADEs) are not only a safety and quality of care issue for patients, but also an economic issue with significant costs. Because they often occur during hospital stays, it is necessary to accurately quantify the costs of ADEs. This review aimed to investigate the methods to calculate these costs, and to characterize their nature. METHODS: A systematic literature review was conducted to identify methods used to assess the cost of ADEs on Medline, Web of Science and Google Scholar. Original articles published from 2017 to 2022 in English and French were included. Economic evaluations were included if they concerned inpatients. RESULTS: From 127 studies screened, 20 studies were analyzed. There was a high heterogeneity in nature of costs, methods used, values obtained, and time horizon chosen. A small number of studies considered non-medical (10%), indirect (20%) and opportunity costs (5%). Ten different methods for assessing the cost of ADEs have been reported and nine studies did not explain how they obtained their values. CONCLUSIONS: There is no consensus in the literature on how to assess the costs of ADEs, due to the heterogeneity of contexts and the choice of different economic perspectives. Our study adds a well-deserved overview of the existing literature that can be a solid lead for future studies and method implementation. TRIAL REGISTRATION: PROSPERO registration CRD42023413071.

Clinical impact of pharmaceutical consultations in patients treated for chronic obstructive pulmonary disease: Study protocol for a randomized controlled trial (BPCObs study).

Background: Chronic obstructive pulmonary disease (COPD) is an irreversible chronic respiratory disease which outcome depends on medication adherence. Pharmacists may increase this adherence by advising patients on inhaler devices proper use. This paper presents the protocol for a randomized controlled trial, which assesses impact of pharmaceutical consultations on COPD exacerbations, medical care, adherence to inhaler devices and quality of life. Methods: This trial will include 226 COPD patients treated with inhaler devices: 94 in a control group, 66 receiving a pharmaceutical consultation at hospital and 66 receiving up to 12 pharmaceutical consultations corresponding to dispensing at their community pharmacy. The aim of these interventions is to inform patients about COPD medication, train them in the use of inhaler devices and improve adherence. Patients included by hospital pharmacist will be randomly assigned to the control and hospital experimental groups. Community pharmacists (CP) will include patients in the experimental community group. CPs will follow-up all study patients for 12 months. Primary outcome is the mean number of COPD exacerbations. Secondary outcomes include number of medical consultations, emergency visits and hospitalizations, patients' adherence devices and quality of life. Discussion: This is the first French trial which assesses both hospital and community pharmaceutical interventions on COPD patients. Study limitations include recruitment and CP adherence to follow-up. Indeed, the success of this trial depends on the willingness of CPs to collect the data. This work is the first step towards building a network of CPs trained for clinical research. Trial registration: Clinicaltrials.gov, NCT03704545. Registered on October 12th, 2018. https://clinicaltrials.gov/ct2/show/NCT03704545?cond=COPD&cntry=FR&city=nimes&draw=2&rank=1.

ABO blood group and von Willebrand factor levels partially explained the incomplete penetrance of congenital thrombophilia.

OBJECTIVE: We aimed to study the association among ABO blood group, von Willebrand factor, factor VIII plasma levels, and the risk of venous thrombosis (VT) in a cohort of 1774 relatives from 500 families with inherited thrombophilia. METHODS AND RESULTS: One hundred sixty-one of the 1774 relatives had a VT. Different risk groups were formed: no, low-(factor V Leiden or F2G20210A heterozygous carriers), and high-risk thrombophilia (antithrombin, protein C, protein S, factor V Leiden, or F2G20210A homozygous carriers and combined defects). Compared with group O, AB blood group was associated with increased risk of VT: hazard ratio (HR)=3.8 (2.0-7.2). The effect of blood group A and B was milder (HR=1.6 [1.1-2.5] and 1.8 [1.0-3.3], respectively). An increased risk of VT was observed with increasing levels of von Willebrand factor and factor VIII plasma levels (HR=2.96 [1.92-4.56] and HR=2.60 [1.92-4.56] for third versus first tertile of von Willebrand factor and factor VIII plasma levels, respectively). In multivariate analysis, AB group (HR=2.3 [1.1-4.8]), high-risk thrombophilia (HR=2.8 [1.6-4.6]), and high von Willebrand factor levels (HR=2.3 [1.3-4.0]) were significantly associated with increased risk of VT. The risk of VT in individuals with high-risk thrombophilia and AB group was 14.4× higher than in those without thrombophilia and O group (5.0-41.4). CONCLUSIONS: ABO blood group modifies the risk of VT in families with hereditary thrombophilia. Phenotyping of the ABO blood group should be performed to better assess the risk of VT in asymptomatic individuals from thrombophilic families.

Clinical and Serological Follow-Up of 216 Patients with Hematological Malignancies after Vaccination with Pfizer-BioNT162b2 mRNA COVID-19 in a Real-World Study.

Hematological malignancies (HMs) have heterogeneous serological responses after vaccination due to disease or treatment. The aim of this real-world study was to analyze it after Pfizer-BioNT162b2 mRNA vaccination in 216 patients followed up for 1 year. The first 43 patients had an initial follow-up by a telemedicine (TM) system with no major events reported. The anti-spike IgG antibodies were checked 3-4 weeks post-first vaccination and every 3-4 months, by two standard bioassays and a rapid serological test (RST). Vaccine boosts were given when the level was <7 BAU/mL. Patients who did not seroconvert after 3-4 doses received tixagevimab/cilgavimab (TC). Fifteen results were discordant between two standard bioassays. Good agreement was observed between the standard and RST in 97 samples. After two doses, 68% were seroconverted (median = 59 BAU/mL) with a median of 162 BAU/mL and 9 BAU/mL, respectively, in untreated and treated patients (p < 0.001), particularly for patients receiving rituximab. Patients with gammaglobulin levels < 5 g/L had reduced seroconversion compared to higher levels (p = 0.019). The median levels were 228 BAU/mL post-second dose if seroconverted post-first and second, or if seroconverted only post-second dose. A total of 68% of post-second dose negative patients were post-third dose positive. A total of 16% received TC, six with non-severe symptomatic COVID-19 within 15-40 days. Personalized serological follow-up should apply particularly to patients with HMs.

Health economic evaluation of a clinical pharmacist's intervention on the appropriate use of devices and cost savings: A pilot study.

BACKGROUND: Good management of disposable and reusable supplies may improve surgical efficiency in the operating room (OR) and also corresponds to the best eco-responsible approach. The purpose of this study was to assess the impact of a clinical pharmacist's intervention in the OR on the non-compliant use of medical devices. We also assessed the economic impact of the pharmaceutical intervention. MATERIALS AND METHODS: We conducted a monocentric prospective study in the OR of a University hospital over one year. Three surgical specialties: urologic, digestive and gynecologic were audited after a preparatory phase to optimize usage of medical devices used for surgeries. The supply costs concerning the three specialties were compared before and after the pharmacist intervention. RESULTS: One hundred and fifty surgical procedures were audited in digestive (33.3%, n = 50), gynecologic (32%, n = 48) and urologic (34.7%, n = 52) surgeries. With the pharmacist in OR, 51 procedures (34% CI95%[26.4%; 41.6%]) with a non-compliance concerning at least one medical device were found compared to the 50% rate without the pharmacist reported previously (P < .0001). Eighteen percent of surgical procedures had at least one circulator retrieval for the reason "incomplete case cart despite device listed on the case cart list" versus 29.1% before pharmacist intervention (P = .0028). A €33 014 saving associated with the presence of the pharmacist in OR was observed. CONCLUSIONS: This prospective interventional study showed that the intervention of a pharmacist specialized in the medical device field could significantly reduce non-compliances in medical device use and reduce costs in OR.

Impact of pharmacist-led multidisciplinary medication review on the safety and medication cost of the elderly people living in a nursing home: a before-after study.

Objectives: Adverse drug events (ADE) are a common cause of morbidity and mortality in elderly patients. In this study, we assessed the impact of multidisciplinary medication review (MMR) for nursing home residents on patient safety and costs incurred by the hospital and the national health service. Methods: Medical files of residents were retrospectively assessed for medications prescribed in the previous six months. A pharmacist reviewed the prescriptions and suggested modifications to the patient's medical team. Patients were followed for six months. Trivalle's ADE geriatric risk score was calculated before and after MMR, as were number of potentially inappropriate medications, and economic impact from the perspective of the health care system and the nursing home. Results: Forty-nine patients were recruited. ADE score dropped one risk level (median score of 4 before versus 1 after, p < 0.0001). The number of patients taking at least one potentially inappropriate medication decreased from 30.6% before to 6.1% after MMR (p = 0.005). A mean saving of €232 per patient was made from the nursing home perspective following MMR (p = 0.008). Conclusion: The MMR reduced the iatrogenic drug risk for elderly residents and costs from the nursing home perspective, particularly drug expenditure.

Analgesic gas for rehabilitation of frozen shoulder: Protocol for a randomized controlled trial.

BACKGROUND: There is little evidence regarding the best way to treat adhesive capsulitis. Physical therapy can reduce pain and improve function and range of motion. However, we lack clear indications on the regimen, techniques or intensity of physical therapy to achieve better results. Intensive physical therapy seems to be confined to the later stages of adhesive capsulitis (chronic stage) given that rehabilitation-induced pain could worsen the outcomes. Here we describe a protocol for a study comparing the efficacy of a standardized program of intensive mobilization under analgesic gas to a similar program under placebo gas and questioning the impact of pain. METHOD/DESIGN: A randomized, double-blind, multicenter study - the MEOPA Trial - was designed to include adults with strictly defined clinical adhesive capsulitis for a 14-day intensive physical rehabilitation program under an equimolar mixture of oxygen and nitrous oxide or sham gas administration. Efficacy will be assessed by the Constant-Murley score. Data for secondary criteria including pain, disability, quality of life and perceived efficacy by the patient or physiotherapist will be collected over 6 months. DISCUSSION: This randomized controlled trial has been designed to test the effectiveness of intensive physical therapy under a simple and safe analgesic method. This study will also address the effect of pain during rehabilitation in adhesive capsulitis. Furthermore, results from the 6-month multidimensional follow-up of painful mobilization for this condition could be extrapolated to other musculoskeletal conditions. TRIAL REGISTRATION: ClinicalTrials.gov No. NCT01087229.

Methodological considerations in cost of prostate cancer studies: a systematic review.

OBJECTIVES: Cost-of-illness (COI) studies estimate the overall economic burden of a specific disease, rather than simply treatment-related costs. While having been criticized for not allowing resource prioritization, COI studies can provide useful guidance, so long as they adhere to accepted methodology. Prostate cancer is an important disease in terms of economic implications because of its increasing incidence and health-care costs and therefore provides a relevant example with which to review COI study methodologies. The aim of this study was to review published COI studies on prostate cancer to analyze the methods used. METHODS: First, we provide a general description of the COI method. COI studies relating to prostate cancer were then systematically reviewed, focussing on an analysis of the different methods used. RESULTS: The methods, data sources, and estimated cost categories in each study varied widely. The review showed that COI studies adopted significantly different approaches to estimate the costs of prostate cancer, reflecting a lack of consensus on the methodology of COI studies in this area. CONCLUSION: To increase its credibility, closer agreement among researchers on the methodological principles of the COI studies would be desirable.