Late Functional Changes Post-Severe Traumatic Brain Injury Are Related to Community Reentry Support: Results From the PariS-TBI Cohort.

OBJECTIVES: To explore late functional changes after a traumatic brain injury and their relation to patients' characteristics and reentry support. DESIGN: Prospective follow-up of an inception cohort of adults with severe traumatic brain injury recruited in 2005-2007 in the Parisian area, France. One and 4-year assessments were performed by trained neuropsychologists. One-to-4-year change in the Glasgow Outcome Scale-Extended defined 3 groups: "improvement," "stability," and "worsening." Relationships between these groups and patients' characteristics were analyzed. RESULTS: Among 504 recruited patients and 245 four-year survivors, 93 participated in both evaluations. Overall Glasgow Outcome Scale-Extended improved by 0.4. Forty percent of the sample improved, 44% were stable, and 16% worsened. Being in a more unfavorable group was related to preinjury alcohol abuse and to higher anxiety and depression at 4 years. Attendance to a specialized community reentry unit was related to higher chances of being in the "improvement" group in univariate analyses and after adjustment for age, time to follow command, preinjury alcohol and occupation, and mood disorders (adjusted odds ratio [OR] = 4.6 [1.1-20]). CONCLUSION: Late functional changes were related to psychosocial variables and to reentry support. The effect of reentry support on late recovery needs to be confirmed by further investigations.

Global ultrasound assessment of structural lesions in osteoarthritis: a reliability study by the OMERACT ultrasonography group on scoring cartilage and osteophytes in finger joints.

OBJECTIVE: Ultrasonography is sensitive for the evaluation of cartilage pathology and degree of osteophytes in patients with hand osteoarthritis (OA). High consistency of assessments is essential, and the OMERACT (Outcome Measures in Rheumatology) ultrasonography group took the initiative to explore the reliability of a global ultrasonography score in patients with hand OA using semiquantitative ultrasonography score of cartilage and osteophytes in finger joints. METHODS: Ten patients with hand OA were examined by 10 experienced sonographers over the course of two days. Semiquantitative scoring (0-3) was performed on osteophytes (carpo-metacarpal 1, metacarpo-phalangeal (MCP) 1-5, proximal interphalangeal 1-5 and distal interphalangeal 2-5 joints bilaterally with an ultrasonography atlas as reference) and cartilage pathology (MCP 2-5 bilaterally). A web-based exercise on static cartilage images was performed a month later. Reliability was assessed by use of weighted κ analyses. RESULTS: Osteophyte scores were evenly distributed, and the intraobserver and interobserver reliabilities were substantial to excellent (κ range 0.68-0.89 and mean κ 0.65 (day 1) and 0.67 (day 2), respectively). Cartilage scores were unevenly distributed, and the intraobserver and interobserver reliability was fair to moderate (κ range 0.46-0.66 and mean κ 0.39 (day 1) and 0.33 (day 2), respectively). The web-based exercise showed acceptable agreement for cartilage being normal (κ 0.47) or with complete loss (κ 0.68), but poor for the intermediate scores (κ 0.22-0.30). CONCLUSIONS: Use of the present semiquantitative ultrasonography scoring system for cartilage pathology in hand OA is not recommended (while normal or total loss of cartilage may be assessed). However, the OMERACT ultrasonography group will endorse the use of semiquantitative scoring of osteophytes with the ultrasonography atlas as reference.

EULAR recommendations for the use of imaging in the diagnosis and management of spondyloarthritis in clinical practice.

A taskforce comprised of an expert group of 21 rheumatologists, radiologists and methodologists from 11 countries developed evidence-based recommendations on the use of imaging in the clinical management of both axial and peripheral spondyloarthritis (SpA). Twelve key questions on the role of imaging in SpA were generated using a process of discussion and consensus. Imaging modalities included conventional radiography, ultrasound, magnetic resonance imaging, computed tomography (CT), positron emission tomography, single photon emission CT, dual-emission x-ray absorptiometry and scintigraphy. Experts applied research evidence obtained from systematic literature reviews using MEDLINE and EMBASE to develop a set of 10 recommendations. The strength of recommendations (SOR) was assessed by taskforce members using a visual analogue scale. A total of 7550 references were identified in the search process, from which 158 studies were included in the systematic review. Ten recommendations were produced using research-based evidence and expert opinion encompassing the role of imaging in making a diagnosis of axial SpA or peripheral SpA, monitoring inflammation and damage, predicting outcome, response to treatment, and detecting spinal fractures and osteoporosis. The SOR for each recommendation was generally very high (range 8.9-9.5). These are the first recommendations which encompass the entire spectrum of SpA and evaluate the full role of all commonly used imaging modalities. We aimed to produce recommendations that are practical and valuable in daily practice for rheumatologists, radiologists and general practitioners.

[Use of social and health primary care services for older people with complex needs: Comparison of three types of gerontological coordination]. / Utilisation des services d'aide et de soins à domicile pour les personnes âgées en situations complexes : comparaison entre trois types de coordination gérontologique.

BACKGROUND: Older people with complex needs live mainly at home. Several types of gerontological coordinations have been established on the French territory to meet their needs and to implement social and primary health care services. But we do not have any information on the use of these services at home as a function of the coordination method used. METHODS: We compared the use of home care services for older people with complex needs in three types of coordination with 12 months' follow-up. The three coordinations regrouped a gerontological network with case management (n=105 persons), a nursing home service (SSIAD) with a nurse coordination (n=206 persons) and an informal coordination with a non-professional caregiver (n=117 persons). RESULTS: At t0, the older people addressed to the gerontological network had less access to the services offered at home; those followed by the SSIAD had the highest number of services and of weekly interventions. Hours of weekly services were two-fold higher in those with the informal coordination. At t12, there was an improvement in access to services for the network group with case management and an overall increase in the use of professional services at home with no significant difference between the three groups. CONCLUSION: The use of social and primary health care services showed differences between the three gerontological coordinations. The one-year evolution in the use of home services was comparable between the groups without an explosion in the number of services in the network group with case management.

Predictive factors for 1-year outcome of a cohort of patients with severe traumatic brain injury (TBI): results from the PariS-TBI study.

OBJECTIVES: To assess outcome and predicting factors 1 year after a severe traumatic brain injury (TBI). METHODS: Multi-centre prospective inception cohort study of patients aged 15 or older with a severe TBI in the Parisian area, France. Data were collected prospectively starting the day of injury. One-year evaluation included the relatives-rating of the Dysexecutive Questionnaire (DEX-R), the Glasgow Outcome Scale-Extended (GOSE) and employment. Univariate and multivariate tests were computed. RESULTS: Among 257 survivors, 134 were included (mean age 36 years, 84% men). Good recovery concerned 19%, moderate disability 43% and severe disability 38%. Among patients employed pre-injury, 42% were working, 28% with no job change. DEX-R score was significantly associated with length of education only. Among initial severity measures, only the IMPACT prognostic score was significantly related to GOSE in univariate analyses, while measures relating to early evolution were more significant predictors. In multivariate analyses, independent predictors of GOSE were length of stay in intensive care (LOS), age and education. Independent predictors of employment were LOS and age. CONCLUSIONS: Age, education and injury severity are independent predictors of global disability and return to work 1 year after a severe TBI.

The reliability of musculoskeletal ultrasound in the detection of cartilage abnormalities at the metacarpo-phalangeal joints.

OBJECTIVE: To assess the reliability of ultrasound (US) in detecting cartilage abnormalities at the metacarpo-phalangeal (MCP) joints in people with cartilage pathology. METHODS: Nine expert ultrasonographers initially achieved consensus on definitions and scanning protocols. They then examined the second to fifth MCP joints of the dominant hand of eight people with hand osteoarthritis (OA). US examinations were conducted in two rounds, with independent blinded evaluations of cartilage lesions. Global cartilage abnormalities were assessed by applying a dichotomous (presence/absence) score; in addition, the following lesions were evaluated using the same scoring system: loss of anechoic structure and/or thinning of the cartilage layer, and irregularities and/or loss of sharpness of at least one cartilage margin. Reliability was assessed using kappa (k) coefficients. RESULTS: Thirty-two joints were examined. Intra-observer k values ranged from 0.52 to 1 for global cartilage abnormalities; k values ranged from 0.54 to 0.94 for loss of anechoic structure and/or thinning of cartilage layer and from 0.59 to 1 for irregularities and/or loss of sharpness of at least one cartilage margin. Values of k for inter-observer reliability were 0.80 for global cartilage abnormalities, 0.62 for loss of anechoic structure and/or thinning of cartilage layer, and 0.39 for irregularities and/or loss of sharpness of at least one cartilage margin. CONCLUSION: US is a reliable imaging modality for the detection of cartilage abnormalities in patients with cartilage pathology in the MCP joints. The analysis of specific cartilage measures showed more variable results that may be improved by modifying definitions and further standardization of US techniques.

Intermittent self-catheterization habits and opinion on aseptic VaPro catheter in French neurogenic bladder population.

STUDY DESIGN: Interventional, multi-center, open-label, randomized and crossover study. OBJECTIVES: The study objectives were to describe the current catheterization habits of the French neurogenic bladder patients using intermittent catheterization (IC), and to evaluate the ease of use, reliability and patients' comfort and patients' acceptance of the new 'no-touch', presumably easy-to-use VaPro catheter. SETTING: Patients were recruited from 11 centers in France. METHODS: In total, 106 men and women (age 18-65 years) with neurogenic bladder using IC at least four times a day were randomized into two groups. All subjects were trained to use the approved 'no-touch' method. A questionnaire evaluating patients' experiences was distributed before the start of the trial and after each 15-day period of catheter use, that is, VaPro vs conventional catheter. RESULTS: The majority of patients in this French IC user panel had very strong catheterization habits: 2/3 of them had been using IC for >2 years with high ease of use and comfort. Nevertheless, >50% of patients would recommend the VaPro catheter to other people who need IC. More than three out of four patients felt confident and more secure with the new catheter. Men and spinal cord injury (SCI) patients were significantly more positive about the VaPro catheter than women and patients without SCI, respectively. CONCLUSION: The VaPro catheter is an acceptable and reliable alternative to the existing hydrophilic-coated 'no-touch' catheter. SPONSORSHIP: This study was sponsored by Hollister France Inc.

Which knee and probe position determines the final diagnosis of knee inflammation by ultrasound? Results from a European multicenter study.

PURPOSE: To investigate which knee and probe position best identifies knee inflammation and to determine a cut-off level for abnormal synovial effusion. MATERIALS AND METHODS: 18 experienced sonographers (all rheumatologists) performed ultrasound examinations of the knee joint in patients with knee symptoms and in healthy controls. Each sonographer performed longitudinal suprapatellar ultrasound scans using 9 different configurations at each knee: Midline, parapatallar lateral and parapatellar medial from midline in neutral position (0°) with and without quadriceps muscle contraction and in 30° flexion of the knee. The presence of synovial effusion (SE), the effusion measured in millimeters and the presence of synovial hypertrophy (SH) was noted. RESULTS: A total of 298 knees of 149 subjects (129 patients and 20 controls) were examined. The detection of SH is more sensitive and specific than the detection of SE, independently of the knee and probe position, for the final diagnosis of abnormality. The detection of both synovial hypertrophy and effusion in the knee in neutral position (0°) with quadriceps contraction and with the probe in the midline position, are the best independent predictors for knee abnormalities. Knee effusion > 3.2 mm measured with the probe in the lateral aspect of the knee is the best diagnostic characteristics for predicting pathological SE. CONCLUSION: The best combination for detecting SH and SE is obtained by placing the probe in the midline position with the knee in 0° with quadriceps contraction. A cut-off value for pathological effusion may be obtained in the lateral aspect of the knee.

[Management of neurogenic bladder patients in France: a survey carried out by the French-speaking neurourology study group (GENULF)]. / Prise en charge des patients ayant une vessie neurologique en France: une enquête du groupe d'études de neuro-urologie de langue française (GENULF).

OBJECTIVE: To design and run a survey aiming at investigating urologists' and physiatrists' clinical practices in France when managing neurogenic bladder patients. PATIENTS AND METHODS: Three thousand one hundred and eighty questionnaires were sent to the members of four French societies involved in treating neurogenic bladder dysfunction. Questions were focused on consultations, clinical follow-up and patient management. RESULTS: Two hundred and seventy-four urologists and 109 physiatrists completed the questionnaire. The frequency of systematic follow-up differed between urologists (6 months) and physiatrists (12 months). Upper urinary tract imaging and systematic urodynamic follow-up were usually performed yearly. The latter was carried out by 56% urologists and 83% physiatrists. Urinary retention was essentially treated by intermittent catheterization. Less than 15% of urologists and physiatrists were treating bacteriuria. Symptomatic urinary infections were treated for 11 to 12 days (men) and for 8 to 9 days (women). To treat their patients, both specialists used self-catheterization education and botulinum toxin A injections. CONCLUSION: Our survey showed differences in approach between urologists and physiatrists in the management of patients with neurogenic bladder dysfunction. Their clinical practice was most of the time in line with national and international guidelines.

Specific real-time PCR for simultaneous detection and identification of Legionella pneumophila serogroup 1 in water and clinical samples.

Legionella pneumophila, a bacterium that replicates within aquatic amoebae and persists in the environment as a free-living microbe, is the causative agent of Legionnaires' disease. Among the many Legionella species described, L. pneumophila is associated with 90% of human disease, and within the 15 serogroups (Sg), L. pneumophila Sg1 causes more than 84% of Legionnaires' disease worldwide. Thus, rapid and specific identification of L. pneumophila Sg1 is of the utmost importance for evaluation of the contamination of collective water systems and the risk posed. Previously we had shown that about 20 kb of the 33-kb locus carrying the genes coding for the proteins involved in lipopolysaccharide biosynthesis (LPS gene cluster) by L. pneumophila was highly specific for Sg1 strains and that three genes (lpp0831, wzm, and wzt) may serve as genetic markers. Here we report the sequencing and comparative analyses of this specific region of the LPS gene cluster in L. pneumophila Sg6, -10, -12, -13, and -14. Indeed, the wzm and wzt genes were present only in the Sg1 LPS gene cluster, which showed a very specific gene content with respect to the other five serogroups investigated. Based on this observation, we designed primers and developed a classical and a real-time PCR method for the detection and simultaneous identification of L. pneumophila Sg1 in clinical and environmental isolates. Evaluation of the selected primers with 454 Legionella and 38 non-Legionella strains demonstrated 100% specificity. Sensitivity, specificity, and predictive values were further evaluated with 209 DNA extracts from water samples of hospital water supply systems and with 96 respiratory specimens. The results showed that the newly developed quantitative Sg1-specific PCR method is a highly specific and efficient tool for the surveillance and rapid detection of high-risk L. pneumophila Sg1 in water and clinical samples.

Outdoor sports and risk of ultraviolet radiation-related skin lesions in children: evaluation of risks and prevention.

BACKGROUND: Excessive ultraviolet (UV) radiation exposure can cause skin cancers, skin photoageing and cataracts. Children are targeted by sun-protection campaigns because high sun exposure and sunburn in childhood increase the risk of melanoma in adulthood. Little information is available about UV radiation risk and exposure in children who take part in outdoor sports. OBJECTIVE: To evaluate the risk of developing UV radiation-induced skin lesions run by children who practise outdoor sports, and UV radiation exposure and sun-protection measures during a soccer tournament. METHODS: Firstly, we evaluated the relationship between melanocytic naevus - a skin lesion linked with exposure to UV radiation - and outdoor sports in 660 11-year-old children. Secondly, we used the occasion of a 1-day soccer tournament held in the spring to evaluate UV radiation-protective measures used by soccer players and the public. We also evaluated the UV radiation index and cloud cover during the tournament, and calculated the UV radiation dose and minimal erythema dose depending on skin phototype. RESULTS: The naevus count and acquired naevus count measured over the 2 years of the study were higher in the 344 children who practised outdoor sports. Sun-protective measures were insufficient for soccer players and the public. CONCLUSIONS: This study shows that outdoor sports increase the risk of developing UV radiation-induced skin lesions in childhood. During a 1-day soccer tournament held in the spring, children and their parents were inadequately protected against the sun. These results suggest that sun-protection campaigns should be aimed at children who practise popular outdoor sports.

[Severe stroke: prognosis, intensive care admission and withhold and withdrawal treatment decisions]. / AVC graves : pronostic, critères d'admission en réanimation et décisions de limitations et arrêt de traitements.

INTRODUCTION: Stroke can produce irreversible brain damage of massive proportion leading to severe disability and poor quality of life. Resuscitation and mechanical ventilation of these patients remain controversial because of the high mortality and severe disability involved. STATE OF ART: When prognosis is very poor, do-not-resuscitate orders (DNR orders) and withhold or withdrawal of treatment may be discussed. Studies have shown that DNR orders are relatively frequent in acute stroke: up to 30% of all patients, and 50% of which are given upon admission. DNR orders are closely associated with severity of the neurological deficit and age. Precise estimates of withhold and withdrawal of treatment are not available, but terminal extubations in severe stroke could contribute to 40,000 to 60,000 acute stage deaths per year. Little is known about the decision making process and palliative care in these situations. The neurological prognosis is the main explicit criterion. However, evaluation of neurological outcome is highly uncertain and difficult, and does not always reflect quality of life. Several studies have raised the issue of this disability paradox. Thus, physician estimation of prognosis has a profound impact on decisions for life sustaining therapies, and may lead to self-fulfilling prophecies in case of false appreciation of published evidence. Other criteria could influence the withhold and withdrawal of treatment decision, such as social conditions and patient values. PERSPECTIVES AND CONCLUSION: Decisions for life-sustaining therapies in severe stroke are always difficult and often based on subjective and uncertain criteria. We have to improve prognosis estimation and our understanding of patient preferences to promote patient-centered care. An ethical approach may guide these complex decisions.

Home-based exercise in autoimmune myasthenia gravis: A randomized controlled trial.

The tolerance of exercise and its effects on quality of life in myasthenia gravis are not currently backed up by strong evidence. The aim of this study was to determine whether exercise as an adjunct therapy is well tolerated and can improve health-related quality of life (HRQoL) in stabilized, generalized autoimmune myasthenia gravis (gMG). We conducted a parallel-group, multi-center prospective RCT using computer-generated block randomization. Adults with stabilized, gMG, and no contra-indication to exercise, were eligible. Participants received usual care alone or usual care and exercise. The exercise intervention consisted of 3-weekly 40 min sessions of an unsupervised, moderate-intensity home rowing program over 3 months. The primary endpoint was the change in HRQoL from randomization to post-intervention. Assessor-blinded secondary endpoints were exercise tolerance and effects on clinical, psychological and immunological status. Of 138 patients screened between October 2014 and July 2017, 45 were randomly assigned to exercise (n = 23) or usual care (n = 20). Although exercise was well tolerated, the intention-to-treat analysis revealed no evidence of improved HRQoL compared to usual care (MGQOL-15-F; mean adjusted between-groups difference of -0.8 points, 95%CI -5.4 to 3.7). Two patients hospitalized for MG exacerbation were from the usual care group.

Recurrence of spondylarthropathy among first-degree relatives of patients: a systematic cross-sectional study.

OBJECTIVE: To examine the recurrence of manifestations belonging to the spectrum of spondylarthropathy (SpA) in first-degree relatives of patients with SpA, and to estimate the recurrence risk ratio. METHODS: Parents and siblings of consecutive SpA probands have been thoroughly investigated, including clinical data collection, pelvic x ray and human leukocyte antigen (HLA)-B27 status determination. The diagnosis of SpA was made according to European Spondylarthropathy Study Group and/or the Amor criteria. The recurrence risk ratio lambda(1), which gives an estimate of the weight of genetic factors, was calculated as the ratio of the recurrence risk of SpA in first-degree relatives compared with the population prevalence of SpA. The lambda(non-HLA) was obtained by similar calculations restricted to HLA-B27+ individuals. RESULTS: Most manifestations of SpA were more frequent among the 157 HLA-B27+ relatives of 83 probands than among their 111 HLA-B27- relatives. A diagnosis of SpA was made in 50 relatives of 31 (37%) probands. Recurrence was very similar between parents and siblings, without gender difference, resulting in overall recurrence risk of 12% in first-degree relatives and of 22.7% in HLA-B27+ relatives. The lambda(1) value was 40 and the lambda(non-HLA) value was 6.5, very close to the lambda(HLA) value of 6.25 estimated from linkage study in SpA. CONCLUSIONS: A similar recurrence risk of SpA was observed between parents and siblings, consistent with a model of inheritance with no dominance variance and without sex influence. The weight of the non-HLA genetic component was equivalent to that estimated for the HLA locus, and fitted a model of multiplicative interaction between HLA and non-HLA genetic components.

Shopping for psoriasis medications on the Internet.

BACKGROUND: Numerous consumer products, including medicines, can be bought over the Internet. Previous reports indicate that patients are able to purchase the current available treatments, including expensive systemic and biological agents with side-effects, available for use on an outpatient basis. In France, as in most industrialized countries, these drug treatments are available only by prescription. Objective To evaluate whether psoriatic outpatients can buy the full range of psoriasis medications, including biological therapies, without a prescription, via the Internet. METHODS: One investigator acted as a consumer to purchase psoriasis treatments and complementary medicines over the Internet. The website search was limited to a 4-h period. All products had to be available for delivery in France, without a prescription, and be suitable for outpatient use. Key words for the Internet search were combinations of medicinal product names, 'psoriasis', 'shopping', 'pharmacy', 'parapharmacy', entered into two major search engines, Google and Yahoo. RESULTS: The investigator identified 47 websites offering a total of 340 products. All treatments, including biological therapies (etanercept, adalumimab and efaluzimab), were available for purchase with the exception of calcitriol and alefacept, with median prices being higher than the French price. CONCLUSION: This study shows that it is possible for consumers to purchase the majority of treatments for psoriasis via the Internet, including systemic therapies and even the most recent and expensive products such as biological agents, without a prescription.

Association between Hospitalization and Change of Frailty Status in the GAZEL Cohort.

OBJECTIVES: To assess the relationship between changes of frailty status and intervening hospitalizations, using information of the GAZEL cohort, matched with the data of the French National Health Data System. DESIGN: Observational cohort study. PARTICIPANTS: Community-dwelling adults of the GAZEL cohort (n = 12145; aged between 58 and 73 years in 2012). MEASUREMENTS: Frailty was determined with the Strawbridge questionnaire in 2012, 2013 and 2014. Data regarding hospitalizations (notably their number, length of stay, emergency department use, and main diagnosis) were collected from the French National Health Data System. The relationship between intervening hospitalizations and changes of frailty status over time was assessed with multivariate Markov models. RESULTS: The prevalence of frailty was 14% in 2012 and 2013 and 17% in 2014. A total of 2715 changes in frailty status were observed from 2012 to 2014. At least one hospitalization was recorded for 1453 people (12%) between the 2012 and 2013 questionnaires, and 1472 (13%) between the 2013 and 2014 questionnaires. No association was found between intervening hospitalizations and changes of frailty status (aHR 1.14 [0.97-1.35] for robust to frail transition and aHR 0.89 [0.73-1.08] for frail to robust transition). However, repeated hospitalizations, hospitalizations after emergency department use, surgery and several diagnosis groups were significantly associated with transitions towards frailty or its recovery. CONCLUSION: Hospitalizations encompass a wide range of clinical situations, some of them being associated with incident frailty. An early recognition of these situations could help to better prevent and manage frailty in the early old age.

Case volume and mortality in haematological patients with acute respiratory failure.

High case volume is associated with improved survival in medical and surgical conditions. The present study sought to determine whether intensive care unit (ICU) case volume was associated with survival of critically ill patients with haematological malignancies and acute respiratory failure (ARF). A regional database containing data from 1,753 haematological patients with ARF admitted to 28 medical ICUs from 1997 to 2004 was used. Multivariate analysis using mixed models was performed to adjust for severity of illness and other confounding factors, including a propensity score that incorporates differences between ICUs with different case volumes. The three case volume tertiles were: low volume (<12 admissions per year), intermediate volume (12-30 admissions per year), and high volume (>30 admissions per year). In univariate analyses, ICU case volume was not associated with ICU mortality. After adjusting for prognostic factors for ICU mortality and the propensity score, patients in high-volume ICUs had lower mortality than other patients. A case volume increase of one admission per year led to a significant mortality reduction with an odds ratio of 0.98 (95% confidence limits 0.97-0.99). Mortality was independently associated with severity of organ dysfunction. In intensive care units admitting larger numbers of critically ill haematological patients with acute respiratory failure, mortality was lower than in other intensive care units. The mechanisms of the relationship between volume and outcome among haematological patients with acute respiratory deserve additional studies.

[Non-inferiority and equivalence trials: Key methodological issues]. / Essais de non-infériorité et d'équivalence : les points clés de leur méthodologie.

Non-inferiority and equivalence trials aim to promote new treatments that are not expected to be superior to existing ones in a given indication. In order to compensate for a possible loss of efficacy, the new treatment should offer other advantages compared to the reference treatment, a better safety of use for example. Their methods somewhat differ from those of superiority trials, often better known to the medical community. This article presents the key points of the methodology of non-inferiority and equivalence trials in order to inform the readers of such trials about the issues and critical points. The general methodology (hypotheses, decision rules, number of subjects required, and strategy of analysis) is presented using examples and graphic illustrations. The issues and critical points are identified and discussed, in particular the choice of the comparator and of the margin of non-inferiority.

[Evaluation of a multifaceted intervention for implementing national guidelines: the case of physical restraint in geriatric care]. / Evaluation d'une intervention multiple pour implanter des recommandations nationales: le cas de la contention physique passive en gériatrie.

BACKGROUND: There is a growing interest in developing guidelines. The French Agency for accreditation and Evaluation (Anaes) published in October 2000 guidelines on the use of restraint in geriatric care settings because in spite of the risks this practice remains widespread in that type of care setting. A multifaceted intervention was conducted in a Parisian geriatric hospital in order to improve the implementation of the published guidelines. An epidemiological study was conducted to assess the outcomes of this intervention. METHODS: The intervention consisted in distributing educational materials and a specific prescription sheet, and in staff training sessions. A time series study was used to assess outcomes. The three time points were: before the intervention, just after the end of the intervention and one year later. Two dimensions were studied: implementation of the guidelines using markers collected from patients' charts and restraining practices noted in an observational study of hospitalized patients. RESULTS: The results of the study suggest that five recommendations were followed better: restraint prescription (8.7 to 57.4%), writing in the patient chart the reasons for restraining (3.5 to 35.3%), follow-up prescription, assessment of potential benefits and risks for the patient and patient information (0% to 19-34%). Nevertheless, the prevalence of restraint and of devices employed (around 70%) remained unchanged after the intervention. The various outcomes of the intervention might be explained by the guidelines themselves, which were variably practical or precise. Moreover, the effect of certain factors directly related with the use of restraint, a routine practice strongly supported by myths about its efficacy, as well as factors related to intervention design may merely have prevented any decrease in the use of restraint practices. CONCLUSION: Multifaceted intervention can favour implementation of certain national guidelines such as prescribing restraint, but can also fail in stimulating the implementation of others such as decreasing the prevalence of restraint in geriatric practice. Therefore the next intervention should emphasize alternatives to physical restraint practices.

The effect of transcranial direct current stimulation (tDCS) on locomotion and balance in patients with chronic stroke: study protocol for a randomised controlled trial.

BACKGROUND: Following stroke, patients are often left with hemiparesis that reduces balance and gait capacity. A recent, non-invasive technique, transcranial direct current stimulation, can be used to modify cortical excitability when used in an anodal configuration. It also increases the excitability of spinal neuronal circuits involved in movement in healthy subjects. Many studies in patients with stroke have shown that this technique can improve motor, sensory and cognitive function. For example, anodal tDCS has been shown to improve motor performance of the lower limbs in patients with stroke, such as voluntary quadriceps strength, toe-pinch force and reaction time. Nevertheless, studies of motor function have been limited to simple tasks. Surprisingly, the effects of tDCS on the locomotion and balance of patients with chronic stroke have never been evaluated. In this study, we hypothesise that anodal tDCS will improve balance and gait parameters in patients with chronic stroke-related hemiparesis through its effects at cortical and spinal level. METHODS/DESIGN: This is a prospective, randomised, placebo-controlled, double-blinded, single-centre, cross-over study over 36 months. Forty patients with chronic stroke will be included. Each patient will participate in three visits: an inclusion visit, and two visits during which they will all undergo either one 30-min session of transcranial direct current stimulation or one 30-min session of placebo stimulation in a randomised order. Evaluations will be carried out before, during and twice after stimulation. The primary outcome is the variability of the displacement of the centre of mass during gait and a static-balance task. Secondary outcomes include clinical and functional measures before and after stimulation. A three-dimensional gait analysis, and evaluation of static balance on a force platform will be also conducted before, during and after stimulation. DISCUSSION: These results should constitute a useful database to determine the aspects of complex motor function that are the most improved by transcranial direct current stimulation in patients with hemiparesis. It is the first essential step towards validating this technique as a treatment, coupled with task-oriented training. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02134158 . First received on 18 December 2013; last updated on 14 September 2016. Other study ID numbers: P120135 / AOM12126, 2013-A00952-43.