Translation and validation of a French version of the Xerostomia Inventory.

OBJECTIVE: This study aimed to assess the transcultural adaptation and psychometric properties of the French-language version of the Xerostomia Inventory (XI-Fr). METHODS: In total, 65 patients aged 65 years or older were recruited from three departments of a single French hospital. Patients had to have a Mini Mental State Examination score of 10 or more and be able to read and write French. The XI-Fr was administered to all patients after transcultural adaptation, at the start of the study, and again at 7 days after inclusion. We assessed reliability, acceptability, validity, internal consistency and reproducibility of the instrument in its French-language version. RESULTS: The XI-Fr showed good internal consistency (Cronbach's alpha 0.79) and good reliability (intra-class correlation 0.83) at 7 days. Convergent validity showed no relation between salivary flow and XI-Fr score, as with the original instrument. Discriminant validity showed a positive correlation between the XI-Fr and the GOHAI, but no difference for the MNA or miniGDS scores. CONCLUSION: The XI-Fr is a valid and reliable measure of xerostomia in French, with psychometric properties comparable to those of the original English-language version.

Characteristics of COVID-19 Inpatients in Rehabilitation Units during the First Pandemic Wave: A Cohort Study from a Large Hospital in Champagne Region.

Background: Data describing patients hospitalized in medical rehabilitation wards after the acute phase of COVID-19 could help to better understand the rehabilitation needs in the current pandemic situation. Methods: Cohort including all patients with COVID-19 hospitalized in a single, large university hospital in Northeast France from 25 February to 30 April 2020. Results: 479 patients were admitted with COVID-19 during the study period, of whom 128 died (26.7%). Among the 351 survivors, 111 were referred to rehabilitation units, including 63 (17.9%) referred to physical and rehabilitation medicine (PRM) units. The median age of patients referred to rehabilitation units was 72 years. Patients who had been in intensive care, or who had had a long hospital stay, required referral to PRM units. Two biomarkers were associated with referral to rehabilitation units, namely, elevated troponin (p = 0.03) and impaired renal function (p = 0.03). Age was associated with referral to PRM units (p = 0.001). Conclusions: Almost one-third of COVID-19 patients required post-acute care, but only one-fifth had access to PRM units. The optimal strategy for post-acute management of COVID-19 patients remains to be determined. The need for rehabilitation wards during a pandemic is a primary concern in enabling the long-term functioning of infected patients.

Fatigue and quality-of-life in the year following SARS-Cov2 infection.

BACKGROUND: The SARS-COV2 pandemic has been ongoing worldwide since at least 2 years. In severe cases, this infection triggers acute respiratory distress syndrome and quasi-systemic damage with a wide range of symptoms. Long-term physical and psychological consequences of this infection are therefore naturally present among these patients. The aim of this study was to describe the state of health of these patients at 6 (M6) and 12 months (M12) after infection onset, and compare quality-of-life (QOL) and fatigue at these time-points. METHODS: A prospective cohort study was set up at Reims University Hospital. Patients were clinically assessed at M6 and M12. Three scores were calculated to describe patient's status: the modified Medical Research Council score (mMRC) used to determine dyspnoea state, the Fatigue Severity Scale (FSS) and the Short Form 12 (SF12) that was carried out to determine the QOL both mentally and physically (MCS12 and PCS12). Descriptive analysis and comparison of scores between M6 and M12 were made. RESULTS: 120 patients completed both follow-up consultations. Overall, about 40% of the patients presented dyspnoea symptoms. The median mMRC score was 1 Interquartile ranges (IQR) = [0-2] at the two assessment. Concerning FSS scores, 35% and 44% of patients experienced fatigue at both follow-ups. The two scores of SF12 were lower than the general population standard scores. The mean PCS12 score was 42.85 (95% confidence interval (95% CI [41.05-44.65])) and mean MCS12 score of 46.70 (95% CI [45.34-48.06]) at 6 months. At 12 months, the mean PCS12 score was 42.18 (95% confidence interval (95% CI [40.46-43.89])) and mean MCS12 score of 47.13 (95% CI [45.98-48.28]). No difference was found between SF12 scores at 6 and 12 months. CONCLUSIONS: This study pinpoints the persistence of fatigue and a low mental and physical QOL compared to population norms even after 1 year following infection. It also supports the claims of mental or psychological alterations due to infection by this new virus, hence a lower overall QOL in patients.

Association between Heparin Dose and 6-Week Mortality in Patients with COVID-19.

Background: Severe forms of SARS-CoV-2 infections are associated with high rates of thromboembolic complications. Professional societies and expert consensus reports have recommended anticoagulants for COVID-19 hospitalized patients. Our study aimed to compare the effect of therapeutic, intermediate and prophylactic doses of heparin on 6-week survival in patients hospitalized for COVID-19. Methods: The study sample is a French cohort of COVID-19 patients hospitalized between Feb 25th and Apr 30th 2020. Patients were assigned to one of 3 anticoagulation dose groups based on the maximum dose they received for at least three days (prophylactic, intermediate or therapeutic). The main outcome was survival up to 42 days after hospital admission. Multivariate Cox regression models were performed to adjust analyses for confounding factors. Results: A total of 323 patients were included. The mean age of the study sample was 71.6 ± 15 years, and 56.3% were men. Treatment with the intermediate versus prophylactic dose of anticoagulation (HR = 0.50, 95%CI = [0.26; 0.99], p = 0.047) and with therapeutic versus prophylactic dose (HR = 0.58 95%CI = [0.34; 0.98], p = 0.044) was associated with a significant reduction in 6-week mortality, after adjustment for potential confounding factors. Comparison of therapeutic versus intermediate doses showed no significant difference in survival. Conclusions: Our results reported a significant positive effect of intermediate and therapeutic doses of heparin on 6-week survival for hospitalized COVID-19 patients compared with a prophylactic dose.

Utility values and its time to deterioration in breast cancer patients after diagnosis and during treatments.

BACKGROUND: The potential effects of breast cancer (BC) on health-related quality of life (HRQoL) should be considered in clinical and policy decision-making, as the economic burden of BC management is currently assessed. In the last decades, time-to-HRQoL score deterioration (TTD) has been proposed as an approach to the analysis of longitudinal HRQoL in oncology. The main objectives of the current study were to investigate the evolution of the utility values in BC patients after diagnosis and during follow-ups and to evaluate the TTD in utility values among women in all stages of BC. METHODS: Health-state utility values (HSUV) were assessed using the EuroQol 5-Dimension 3-Level at diagnosis, at the end of the first hospitalization and 3 and 6 months after the first hospitalization. For a given baseline score, HSUV was considered to have deteriorated if this score decreased by ≥ 0.08 points of the EQ-5D utility index score and ≥ 7 points of the EQ visual analogue scale. TTD curves were calculated using the Kaplan-Meier estimation method. RESULTS: Overall 381 patients were enrolled between February 2006 and February 2008. The highest proportions of respondents at the baseline and all follow-ups reporting some and extreme problems were in pain discomfort and anxiety/depression dimensions; more than 80% of patients experienced a deterioration in EQ-5D utility index score and EQ VAS score with a median TTD of 3.15 months and 6.24 Months, respectively. CONCLUSIONS: BC patients undergoing therapy need psychological support to cope with their discomfort, pain, depression, anxiety, and fear during the process of diagnosis and treatment to improve their QoL.

Penetration rate of anti-TNF biosimilars and savings at 5 years after their introduction in French hospitals.

OBJECTIVE: Since the expiry of the patents on originator anti-TNF agents in Europe, France has authorized the sale of biosimilars. The penetration rate of anti-TNF agents and their biosimilars, and the cost savings driven by the introduction of biosimilars appears to vary widely. This study aimed to describe the market share of anti-TNFs and their biosimilars, and the cost savings generated by the introduction of biosimilars in French hospitals 5 years ago. METHODS: The pharmaceutical component of the French national uniform hospital discharge data set database (PMSI) was used to study sales of infliximab, etanercept and adalimumab originators and biosimilars, and to estimate cost savings generated by the introduction of biosimilars onto the market, using the historical tariffs of the originators. RESULTS: The penetration rate of anti-TNF biosimilars in France in 76% for infliximab, 74% for etanercept and 77% for adalimumab. In 2020, Inflectra® (41%) was the Remicade® biosimilar with the highest sales volume, while Erelzi® (57%) and Amgevita® (64%) were the most widely sold biosimilars of Enbrel® and Humira® respectively. In terms of cost savings since the launch of biosimilars, overall, for all biosimilars taken together, over the 5-year period, a total of 824 million Euro was saved, in relation to the historical tariffs of the originators. CONCLUSIONS: This study shows firstly that the penetration rate of anti-TNF biosimilars in France 5 years after their launch is close to 80%. Secondly, we show that the cost savings generated by the use of biosimilars to anti-TNF agents exceed 820 million Euro over 5 years.

Acquired decrease of the C3b/C4b receptor (CR1, CD35) and increased C4d deposits on erythrocytes from ICU COVID-19 patients.

In order to study the mechanisms of COVID-19 damage following the complement activation phase occurring during the innate immune response to SARS-CoV-2, CR1 (the regulating complement activation factor, CD35, the C3b/C4b receptor), C4d deposits on Erythrocytes (E), and the products of complement activation C3b/C3bi, were assessed in 52 COVID-19 patients undergoing O2 therapy or assisted ventilation in ICU units in Rheims France. An acquired decrease of CR1 density on E from COVID-19 patients was observed (Mean = 418, SD = 162, N = 52) versus healthy individuals (Mean = 592, SD = 287, N = 400), Student's t-test p < 10-6, particularly among fatal cases, and in parallel with several parameters of clinical severity. Large deposits of C4d on E in patients were well above values observed in normal individuals, mostly without concomitant C3 deposits, in more than 80% of the patients. This finding is reminiscent of the increased C4d deposits on E previously observed to correlate with sub endothelial pericapillary deposits in organ transplant rejection, and with clinical SLE flares. Conversely, significant C3 deposits on E were only observed among » of the patients. The decrease of CR1/E density, deposits of C4 fragments on E and previously reported detection of virus spikes or C3 on E among COVID-19 patients, suggest that the handling and clearance of immune complex or complement fragment coated cell debris may play an important role in the pathophysiology of SARS-CoV-2. Measurement of C4d deposits on E might represent a surrogate marker for assessing inflammation and complement activation occurring in organ capillaries and CR1/E decrease might represent a cumulative index of complement activation in COVID-19 patients. Taken together, these original findings highlight the participation of complement regulatory proteins and indicate that E are important in immune pathophysiology of COVID-19 patients. Besides a potential role for monitoring the course of disease, these observations suggest that novel therapies such as the use of CR1, or CR1-like molecules, in order to down regulate complement activation and inflammation, should be considered.

COVID-19: A qualitative chest CT model to identify severe form of the disease.

PURPOSE: The purpose of this study was to identify clinical and chest computed tomography (CT) features associated with a severe form of coronavirus disease 2019 (COVID-19) and to propose a quick and easy to use model to identify patients at risk of a severe form. MATERIALS AND METHODS: A total of 158 patients with biologically confirmed COVID-19 who underwent a chest CT after the onset of the symptoms were included. There were 84 men and 74 women with a mean age of 68±14 (SD) years (range: 24-96years). There were 100 non-severe and 58 severe cases. Their clinical data were recorded and the first chest CT examination was reviewed using a computerized standardized report. Univariate and multivariate analyses were performed in order to identify the risk factors associated with disease severity. Two models were built: one was based only on qualitative CT features and the other one included a semi-quantitative total CT score to replace the variable representing the extent of the disease. Areas under the ROC curves (AUC) of the two models were compared with DeLong's method. RESULTS: Central involvement of lung parenchyma (P<0.001), area of consolidation (P<0.008), air bronchogram sign (P<0.001), bronchiectasis (P<0.001), traction bronchiectasis (P<0.011), pleural effusion (P<0.026), large involvement of either one of the upper lobes or of the middle lobe (P<0.001) and total CT score≥15 (P<0.001) were more often observed in the severe group than in the non-severe group. No significant differences were found between the qualitative model (large involvement of either upper lobes or middle lobe [odd ratio (OR)=2.473], central involvement [OR=2.760], pleural effusion [OR=2.699]) and the semi-quantitative model (total CT score≥15 [OR=3.342], central involvement [OR=2.344], pleural effusion [OR=2.754]) with AUC of 0.722 (95% CI: 0.638-0.806) vs. 0.739 (95% CI: 0.656-0.823), respectively (P=0.209). CONCLUSION: We have developed a new qualitative chest CT-based multivariate model that provides independent risk factors associated with severe form of COVID-19.

Optic Nerve and Perioptic Sheath Diameter (ONSD), Eyeball Transverse Diameter (ETD) and ONSD/ETD Ratio on MRI in Large Middle Cerebral Artery Infarcts: A Case-Control Study.

BACKGROUND: Despite recent progress in the multidisciplinary management of large middle cerebral artery infarcts, the neurological prognosis remains worrying in a non-negligible number of cases. The objective of this study is to analyze the contribution of optic nerve and perioptic sheath measurement on MRI to the acute phase of large middle cerebral artery infarcts. METHODS: A retrospective case-control study between January 2008 and December 2019 in a single academic medical center was performed. Cases and controls were selected by interrogation of International Classification of Diseases (ICD), 10th edition, with ischemic stroke as criterion (code I64). Decompressive hemicraniectomy was a criterion for large middle cerebral artery infarcts (cases). Cases were matched with controls (1:3) based on age (± 5 years), sex, and year of hospitalization (± 2 years) The examinations were performed on 3T MRI (Siemens IRM 3T Magnetom).Optic nerve and perioptic sheath diameter was calculated using electronic calipers, 3 mm behind retina and in a perpendicular vector with reference to the orbit in axial 3D TOF sequence. RESULTS: Of 2612 patients, 22 patients met all the criteria of large middle cerebral artery infarcts and they were paired with 44 controls. Patients were mainly women, mean age of 53.6 years. There is a significant difference in the size of the optic nerve and perioptic sheath diameter measured on MRI at patient's admission (right: 5.13 ± 0.2 mm vs. 4.80 mm ± 0.18, p <0. 0001, left: 5.16 ± 0.17 vs 4.78 ± 0.20, p<0.0001). The AUC of optic nerve and perioptic sheath diameter was 0.93 (95%IC [0.85-1.00]), for a threshold at 5.03 mm, the sensitivity was 0.82 (95%IC [0.6-0.93]), specificity 0.94 (95%IC [0.85-0.98]). The Odds Ratio of large middle cerebral artery infarcts was 46.4 for optic nerve and perioptic sheath diameter the (95%IC [6.15-350.1] p=0.0002). CONCLUSION: Optic nerve and perioptic sheath diameter in the first MRI can predict the risk of developing large middle cerebral artery infarcts requiring a decompressive hemicraniectomy.

Assessing abdominal aortic calcifications before performing colocolic or colorectal anastomoses: A case-control study.

BACKGROUND: Preoperative evaluation needs objective measurement of the risk of anastomotic leakage (AL). This study aimed to determine if cardiovascular disease, evaluated by abdominal aortic calcification (AAC), was associated with AL after colorectal anastomoses. We conducted a retrospective case-control study on patients who underwent colorectal anastomosis between 2012 and 2016 at Reims University Hospital (France). Abdominal aortic calcification was the main variable of measurement. MATERIALS AND METHODS: We reviewed all patients who had a left-sided colocolic or a colorectal anastomosis, all patients with AL were cases; 2 controls, or 3 when possible, without AL were randomly selected and matched by operation type, pathology, and age. For multivariate analysis, 2 logistic regression models were tested, the first one used the calcification rate as a continuous variable and the second one used the calcification rate ≥ 5% as a qualitative variable. RESULTS: Forty-five cases and 116 controls were included. In univariate analysis, the calcification rate and the percentage of patients with a calcification rate ≥5% were significantly higher in cases than in control groups (4.4 ± 5.5% vs. 2.5 ± 5.2%, odds ratio [OR] =1.6 95% CI: 1.1-2.5; n = 22, 49% and n = 34.3 3%, OR = 2.8 95% CI: 1.2-6.2). In multivariate models, calcification rate as a continuous variable and calcification rate ≥5% as qualitative variable were independent significant risk factors for AL (respectively, aOR = 1.8; 95% CI: 1.1-3, P = 0.01; aOR = 3.2; 95% CI: 1.4-7.55, P < 0.01). CONCLUSION: AAC ≥5% should alert on a higher risk of AL and should lead to discussion about the decision of performing an anastomosis.

Corticosteroid therapy for patients with COVID-19 pneumonia: a before-after study.

Anti-inflammatory drugs such as corticosteroids may beneficially modulate the host inflammatory response to coronavirus disease 2019 (COVID-19) pneumonia. The aim of this study was to evaluate the impact of addition of corticosteroids to the hospital protocol for treatment of suspected or confirmed COVID-19 pneumonia on rates of death or intensive care unit (ICU) admission. A before-after study was performed to evaluate the effect of addition of corticosteroids to our institution's COVID-19 treatment protocol on hospital mortality. A total of 257 patients with a COVID-19 diagnosis were included in this study between 3 March 2020 and 14 April 2020. As corticosteroids were widely used after 27 March 2020, two periods were considered for the purposes of this study: the 'before' period from 3-20 March 2020 (n = 85); and the 'after' period from 26 March-14 April 2020 (n = 172). The 'after' period was associated with a lower risk of death [adjusted hazard ratio (aHR) = 0.47, 95% confidence interval (CI) 0.23-0.97; P = 0.04] and a lower risk of ICU admission or of death before ICU admission (aHR = 0.37, 95% CI 0.21-0.64; P = 0.0005) by multivariate analysis adjusted for age, National Early Warning score and institutionalisation status. In conclusion, addition of corticosteroids to our institution's COVID-19 treatment protocol was associated with a significant reduction in hospital mortality in the 'after' period.

Copper for the Prevention of Outbreaks of Health Care-Associated Infections in a Long-term Care Facility for Older Adults.

OBJECTIVE: We aimed to study the efficacy of copper as an antimicrobial agent by comparing incidence rates during outbreaks in areas equipped vs not equipped with copper surfaces in a long-term facility for dependent older adults (nursing home). DESIGN: Prospective observational pilot study in a nursing home. SETTING AND PARTICIPANT: All persons resident in the nursing home belonging to Reims University Hospital, from February 1, 2015 to June 30, 2016, were included. METHODS: Incidence rates for health care-related infections during outbreaks occurring during the study period were compared between the wing that was equipped and the wing that was not equipped with copper surfaces. Results are expressed as relative risks (RRs) and 95% confidence intervals (95% CIs). RESULTS: During the study period, 556 residents were included; average age was 85.4 ± 9.2 years, and 76% were women. Four outbreaks occurred during the study period: 1 influenza, 1 keratoconjunctivitis, and 2 gastroenteritis outbreaks. The risk of hand-transmitted health care-associated infection was significantly lower in the area equipped with copper surfaces (RR 0.3, 95% CI 0.1-0.5). CONCLUSIONS AND IMPLICATIONS: In our study, copper was shown to reduce the incidence of hand-transmitted health care-associated infections and could represent a relatively simple measure to help prevent HAIs in nursing homes.

[Prognostic value at one year of frailty as evaluated by the SEGA instrument for octogenarians presenting an acute coronary syndrome: PROSECO study]. / Valeur pronostique à 12 mois du niveau de fragilité évalué par la grille SEGA dans le cadre du syndrome coronaire aigu de l'octogénaire : étude PROSECO.

The SEGA instrument has demonstrated good performance in screening for frailty. However, its predictive ability in elderly patients presenting with acute coronary syndrome have never been evaluated. We aimed to study the prognostic value at one year of the frailty level assessed by the SEGA instrument, in a population of patients aged 80 years old or more hospitalised for acute coronary syndrome. All consecutive patients aged 80 years or older hospitalised for myocardial infarction type 1 between November 2016 and October 2017 were included. All underwent standardised geriatric assessment including estimation of frailty by the SEGA instrument. The primary outcome was the time to death from any cause. In all 64 patients were included for a mean age of 85.3±4 years. Using the SEGA instrument, 24% patients were classified "frail" and 44% "very frail"; 18 (28%) deaths were observed during follow-up. When adjusted for patient age, body mass index and arterial hypertension, survival status was not significantly related with frailty status (HR=1.1, 95% CI=0.4-3.1, p=0.8).

Factors related to use of potentially inappropriate psychotropic drugs in 2,343 residents of 19 nursing homes.

To identify factors that influence use of potentially inappropriate psychotropic drugs among elderly residents living in nursing homes (NH). Cross-sectional, multicentre study among 65+ years NH residents, based on queries performed on the PATHOS database and on prescription information from residents' medical data. Medications were coded using the Anatomical Therapeutical Chemical classification. Psychotropic agents were classed using Delay and Deniker's classification, and the Beers Criteria (Beers list 2015 update) were used to identify potentially inappropriate psychotropic drugs (PIPs). Logistic regression was performed to identify factors related to use of potentially inappropriate psychotropic drugs, and factors related to PIPs. The average number of drugs per subject (n=2,343) was 7.8±3.5. In total, 1,709 (71.6%) subjects were taking psychotropic drugs (1.8±0.9 psychotropic drugs per user). Psychotropic agents represented 17.4% of the 18,143 drugs used by the whole study population. The frequency of PIPs was 44.1%. By multivariable analysis, the use of psychotropic drug was significantly associated with behavioural disorders (OR 3.21, 95%CI [2.46-4.18]); depression (OR 8.79, 95%CI [6.64-11.6]); anxiety (OR 3.43, 95%CI [2.45-4.8]); psychosis (OR 2.05, 95%CI [1.28-3.30]), use of >4 drugs (OR 4.85, 95%CI [3.60-6.53]); and dehydration (OR 0.49, 95%CI [0.32-0.75]). PIPs was significantly associated to behavioural disorders (odds ratio (OR) 1.56, 95% confidence interval (CI) [1.89-1.29]); depression (OR 2.90, 95%CI [3.60-2.3]); anxiety (OR 1.68, 95%CI [2.32-1.22]); dementia (OR 2.43, 95%CI [2.96-1.99]); use of >4 drugs (OR 3.41, 95%CI [4.90-2.37]); dehydration (OR 0.53, 95%CI [0.76-0.37]), arthritis/arthrosis of the hip (OR 1.48, 95%CI [2.04-1.07]) and arthritis/arthrosis of the shoulder (OR 2.06, 95%CI [3.43-1.23]). Regular review of prescriptions and emphasis on non-drug therapy of behavioural disorders in elderly subjects can help to reduce the rate of prescription of psychotropic drugs and PIPs in NH residents.

Factors associated with quality of life in patients with Alzheimer's disease.

BACKGROUND: Evaluation of health-related quality of life (HRQoL) in patients with Alzheimer's disease (AD) is necessary to ensure optimal management. Several scales for assessing HRQoL of patients with AD exist, in particular the Quality of Life in Alzheimer's Disease (QoL-AD), which includes an evaluation by the caregiver of the patient's HRQoL. The aim of this study was to identify factors associated with patient, caregiver and overall HRQoL as assessed by the QoL-AD. METHODS: Cross-sectional multicenter study in subjects aged 65 years and older, with mild to moderate AD. HRQoL scores from the QoL-AD were recorded (3 scores, corresponding to patient, caregiver and overall), as well as sociodemographic variables for the patient and the caregiver, and data from the geriatric cognitive assessment (cognitive, psycho-behavioral, functional evaluations). Caregiver burden was evaluated using the Zarit caregiver burden scale. Factors associated with each QoL-AD score were identified by multivariate linear regression using t-tests and ß estimations. Study was registered in Clinical Trial.gov (NCT02814773). RESULTS: In total, 123 patients with AD were included. For the patient QoL-AD evaluation, depression was significantly associated with lower HRQoL (ß = - 2.56 ± 1.28, p = 0.04), while polypharmacy (ß = - 1.80 ± 0.99, p = 0.07) and anxiety (ß = - 1.70 ± 1.01, p = 0.09) tended to be associated with lower HRQoL scores. In terms of caregiver evaluations, depression (ß = - 3.46 ± 1.09, p = 0.002), polypharmacy (ß = - 1.91 ± 0.92, p = 0.04) and the presence of caregiver burden (ß = - 3.50 ± 0.91, p = 0.0002) were associated with lower HRQoL. For the overall evaluation, depression (ß = - 3.26 ± 1.02, p = 0.002) and polypharmacy (ß = - 1.85 ± 0.81, p = 0.03) were significantly related to lower HRQoL. CONCLUSIONS: Depression and polypharmacy were two factors influencing HRQoL in patients with AD, both by patient self-report and on the caregiver report. Thus, despite the discrepancies between HRQoL as assessed by patients with AD and HRQoL as assessed by their caregiver, the caregiver's assessment may be used to guide patient management when the patient can no longer complete QoL evaluations. Moreover, the association between caregiver burden and the caregiver's QoL-AD score underlines the need to take caregivers into consideration in the overall management of the AD patient.

Cost Effectiveness of Intra-Articular Hyaluronic Acid and Disease-Modifying Drugs in Knee Osteoarthritis.

BACKGROUND: The place of disease-modifying osteoarthritis drugs (DMOADs) and intra-articular hyaluronic acid (IAHA) in the therapeutic arsenal for knee osteoarthritis (OA) remains uncertain. Indeed, these treatments have demonstrated symptomatic efficacy but no efficacy for disease modification. OBJECTIVE: This report reviews the cost effectiveness of IAHA and DMOADs used in the treatment of knee OA. METHODS: A systematic literature search of the MEDLINE, Scopus, EMBASE and Cochrane databases was performed independently by two rheumatologists who used the same predefined eligibility criteria to identify relevant articles. Papers without abstracts and in languages other than English or French were excluded. Extracted costs were annualised and converted to 2015 euros (€) using the Consumer Price Index of the relevant countries and the 2013 Purchasing Power Parities between these countries and the European Union average. RESULTS: A total of 95 abstracts were selected, and 13 articles were considered for the review: nine articles on IAHA and four on DMOADs. Only one article directly compared different IAHA compounds. Articles showed substantial heterogeneity in methodological approaches. The incremental cost-effectiveness ratios (ICERs) ranged from €4000 to €57,550 and from €240 to €53,225 per quality-adjusted life-year (QALY) gained for DMOADs and IAHA, respectively. CONCLUSIONS: This review highlights substantial heterogeneity between studies, ranging from a cost saving (or dominating) position to very high ICERs, far above the acceptability threshold of €50,000/QALY. Additional research is needed to determine reliable and robust ICER estimates for knee OA therapies.

A comparison between intravascular and traditional cooling for inducing and maintaining temperature control in patients following cardiac arrest.

Therapeutic temperature control has been widely used during the last decade to improve clinical outcomes. We conducted this retrospective observational study to compare traditional cooling with endovascular cooling in post-cardiac arrest comatose survivors and to compare results with current guidelines. PATIENTS AND METHODS: All patients admitted to our ICU for cardiac arrest and for whom temperature control was performed were included. Traditional cooling included cold infusions, ice packs and cooling blankets. Endovascular cooling consisted in the insertion of a catheter in which cold fluid circulates in a closed circuit provided by a heat exchanger. Temperature control was started at a target temperature of 32°C to 34°C. Rewarming was performed passively in the traditional group and via computer-assistance in endovascular group. We evaluated the delay prior to and speed of cooling, thermic stability during the maintenance phase and the speed of rewarming. RESULTS: Thirty-four patients were included. The speed of cooling was faster with the endovascular (-0.66±0.35°C/h) compared to the traditional (-0.35±0.38°C/h, P=0.006) technique, with target temperatures reached in 4.0 and 6.0h, respectively (P=0.14). Temperatures were more stable with the endovascular technique (0.03±0.05°C2) than with the traditional technique (0.26±0.16°C2, P<10-4). There were more deviations from the guideline target range in the traditional group (64.7% versus 17.6%, P=0.008). Rewarming was faster in the traditional group (+0.64±0.33°C/h, versus +0.36±0.12°C/h, P=0.01). No significant difference was found concerning mortality or length of stay in the ICU. CONCLUSION: Temperature control with a cooling catheter was associated with faster cooling, improved thermic stability in the target range, less overcooling or overheating and slower rewarming in comparison with traditional techniques.

[Clinical research and data collection during the investigation: Influence of a dedicated staff]. / Recherche clinique et recueil de données lors de l'investigation : influence d'un personnel dédié.

OBJECTIVE: In clinical research, the recourse to a staff dedicated as CRA with the investigator is common practice to facilitate the work of collection and limiting the missing data (MD). We, therefore, looked for the interest of the recourse of such personnel to data collection. METHODS: MD were classified according to five categories: clinical, para-clinical, treatment, adverse events (serious) and others. Studies were separated in two designs, one-off studies during a single visit (so-called "no follow") and studies on the duration and including several visits (say "with follow"). Similarly, studies were differentiated according to their type of collection "Without ARC" if the data were collected by an investigator, and studies "With ARC". RESULTS: The presence of a CRA can reduce the number of MD whatever their type (Student test: P<0.0001): With CRA mean of MD is 4.8%±8.4% and Without CRA mean of MD is 22.1%±17.0%. CONCLUSION: The delegation of data collection to a staff dedicated reduces significantly the percentage of missing data.

Is functional mobility an independent mortality risk factor in subjects with dementia?

OBJECTIVE: To investigate whether functional mobility is a predictor of 12-month mortality in elderly subjects with dementia. STUDY DESIGN: Prospective multicentre study performed in nine French university hospitals. Patients aged 75 years or more and hospitalised in medical wards via the emergency department were eligible. Those with a diagnosis of dementia were considered in the analyses. MAIN OUTCOME MEASURES: Patients' characteristics obtained through comprehensive geriatric assessment performed during the first week of hospitalisation. Functional mobility was assessed using the timed "Up & Go" test. The main outcome was time to death within the 12 months of follow-up. Bivariable relationships between each risk factor and mortality were assessed using a Cox regression model with one explanatory variable. For multivariable analysis, the Cox regression model was used in a stepwise method after examining potential confounders and interactions. RESULTS: In all, 589 patients had a diagnosis of dementia, and were considered in the present analyses. Their mean age was 86±6years and most (69%) were female. The prevalence of functional mobility disorders was 86%. After 12 months, 232 (39%) had died. After adjustment for potential confounders, functional mobility was associated with a significantly higher risk of 12-month mortality (HR=1.66; 95% CI=1.02-2.71; p=0.04). CONCLUSIONS: Impaired functional mobility as assessed by the timed Up & Go test identifies subjects with dementia at risk of unfavourable outcome.