Global Severity Score Research Articles

Predictive value of chest CT scoring in COVID-19 patients in Wuhan, China: A retrospective cohort study

BackgroundComputed tomography (CT) findings of COVID-19 patients were demonstrated by cases series and descriptive studies, but quantitative analysis performed by clinical doctors and studies on its predictive value were rarely seen. The aim of the study is to analyze CT score in COVID-19 patients and explore its predictive value. Materials and methodsWe conducted a retrospective cohort study among confirmed COVID -19 patients with available CT images between February 8, 2020 and March 7, 2020. The lung was divided into six zones by the level of tracheal carina and the level of inferior pulmonary vein bilaterally on CT. Ground-glass opacity (GGO), consolidation, crazy-paving pattern and overall lung involvement were rated by Likert scale of 0–4 or binary as 0 or 1. Global severity score for each targeted pattern was calculated as total score of six zones. ResultsThere were 53 patients and 137 CT scans included in the study. There were 18(34%) of the patients classified as moderate cases while 35(66%) patients were severe/critical cases. Severe/critical patients had higher CT scores in several types of abnormalities than moderate patients from the second week to the fourth week post symptom onset. Overall lung involvement score in the second week demonstrated predictive value for severity with a sensitivity of 81.0% and specificity of 69.2%. ConclusionsOur modified semi-quantitative CT scoring system for COVID-19 patients demonstrated feasibility. Overall lung involvement score on the second week had predictive value for clinical severity and could be indicator for further treatment.

Applying Item Response Theory to the OPD Structure Questionnaire: Identification of a Unidimensional Core Construct and Feasibility of Computer Adaptive Testing

Recent developments in the dimensional assessment of personality functioning have made the implementation of latent measurement models increasingly attractive. In this study, we applied item response theory (IRT) to a well-established personality functioning instrument (the OPD Structure Questionnaire) to identify a unidimensional latent trait and to evaluate the feasibility of computer adaptive testing (CAT). We hypothesized that the use of IRT could reduce the test burden – compared to a fixed short form – while maintaining high precision over a wide range of the latent trait. The OPD-SQ was collected from 1235 patients in a psychosomatic clinic. IRT assumptions were fulfilled. A 9-factor model yielded sufficient fit and unidimensionality in exploratory factor analysis with bifactor rotation. Items were iteratively reduced, and a graded-response IRT model was fitted to the data. Simulations showed that a CAT with approximately 7 items was able to capture an OPD-SQ global severity score with an accuracy similar to that of a fixed 12-item short form. The final item bank and CAT yielded satisfactory content validity. Strong correlations with depression and anxiety replicated previous results on the OPD-SQ. We concluded that IRT applications could be useful to reduce the test burden of personality functioning instruments.

Surgical Outcome of Open Carpal Tunnel Release Using Global Symptom Severity Score

Objective: Purpose of conducting this study was to evaluate the surgical outcome of open carpal tunnel release using Global Symptom Severity score (GSS) in our local setting.
 Material and Methods: This prospective analytical study was conducted in the Neurosurgery Department Hayatabad Medical Complex, Peshawar. We operated consecutive 105 Carpal tunnel syndrome cases over a period of 2 years via open carpal tunnel release (OCTR) method. All of these cases were surgically indicated. All patients were evaluated preoperatively with clinical assessment and NCS. Cases were operated under local anesthesia as a day case surgery. Patients were evaluated at 3 months follow-up visit using global symptom severity score (GSS) and compared with pre operative GSS. The paired sample test was applied to obtain p value.
 Results: Total 105 patients were operated during study period. 72 (69%) patients were women and 33 (31%) were men. The mean age of patients was 41 years. 70 (66.66%) procedures were done for the right hand and 35 (33.33%) were performed for left hand. Pre-op Mean GSS score was 27 ± 2.5 which decreased to 2.1 ± 0.43 postoperatively (P < 0.005).
 Conclusion: Carpal tunnel syndrome is more commonly affecting the dominant hand of middle aged females. Open carpal tunnel release procedure is the safe and effective treatment for this compressive neuropathy.

The safety of agomelatine in standard medical practice in depressed patients: A 26-week international multicentre cohort study.

ObjectiveThe present observational cohort study documented the safety of agomelatine in current medical practice in out‐patients suffering from major depressive disorder.MethodThe 6‐month evolution of agomelatine‐treated patients was assessed with a focus on safety (emergent adverse events, liver acceptability), severity of depression using the Clinical Global Impression Severity (CGI‐S) score, and functioning measured by the Sheehan Disability Scale (SDS).ResultsA total of 8453 depressed patients from 761 centres in 6 countries were analysed (female: 67.7%; mean age: 49.1 ± 14.8 years). Adverse events reported were in accordance with the known safety profile of agomelatine. Cutaneous events were reported in 1.7% of the patients and increased hepatic transaminases values were reported in 0.9 % of the patients. The incidence of events related to suicide/self‐injury was 1.0%. Two completed suicides, not related to the study drug, were reported. CGI‐S total scores and SDS sub‐scores improved and numbers of days lost or underproductive decreased over the treatment period.ConclusionsIn standard medical practice, agomelatine treatment was associated with a low incidence of side effects. No unexpected events were reported. A decrease in the severity of the depressive episode and improved functioning were observed.Trial registration nameObservational cohort study to evaluate the safety of agomelatine in standard medical practice in depressed patients. A prospective, observational (non‐interventional), international, multicentre cohort study.Trial registration numberISRCTN53570733

Mental health status in veterans residing in rural versus non-rural areas: results from the veterans\u2019 health study

BackgroundThe majority of Veterans Affair (VA) hospitals are in urban areas. We examined whether veterans residing in rural areas have lower mental health service use and poorer mental health status.MethodsVeterans with at least 1 warzone deployment in central and northeastern Pennsylvania were randomly selected for an interview. Mental health status, including PTSD, major depression, alcohol abuse and mental health global severity, were assessed using structured interviews. Psychiatric service use was based on self-reported utilization in the past 12 months. Results were compared between veterans residing in rural and non-rural areas. Data were also analyzed using multivariate logistic regression to minimize the influence by confounding factors.ResultsA total of 1730 subjects (55% of the eligible veterans) responded to the survey and 1692 of them had complete geocode information. Those that did not have this information (n = 38), were excluded from some analyses. Veterans residing in rural areas were older, more often of the white race, married, and experienced fewer stressful events. In comparison to those residing in non-rural areas, veterans residing in rural areas had lower global mental health severity scores; they also had fewer mental health visits. In multivariate logistic regression, rural residence was associated with lower service use, but not with PTSD, major depression, alcohol abuse, and global mental health severity score after adjusting confounding factors (e.g., age, gender, marital status and education).ConclusionsRural residence is associated with lower mental health service use, but not with poor mental health in veterans with former warzone deployment, suggesting rural residence is possibly protective.

Testing a quality‐of‐life questionnaire in Dutch people with hand eczema

British Journal of DermatologyVolume 183, Issue 1 p. e11-e11 Plain Language SummaryFree Access Testing a quality-of-life questionnaire in Dutch people with hand eczema First published: 01 July 2020 https://doi.org/10.1111/bjd.19181AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat Abstract Hand eczema interferes with many aspects of everyday life. This is an important consideration but such interference is hard to measure. Any scoring system must itself be carefully assessed to make sure it is relevant, reliable and sensitive enough to pick up any meaningful change before and after any new treatment. Doctors in the Netherlands studied the Dutch version of an internationally recognised measurement instrument (system), the Quality Of Life in Hand Eczema Questionnaire (QOLHEQ). This instrument has 30 questions covering symptoms, emotions, functioning and treatment during the past week, with answers on a five-point scale. They tested it on 300 adults and repeated the test after 3 days and 4-12 weeks. They also photographed and scored the hand eczema severity and used several other quality of life measures for comparison. QOLHEQ scores from people whose eczema was unchanged after 3 days, according to a global severity score, were used to assess how reproducible this measurement was; and those whose global severity score changed after 3 days to 4-12 weeks were used to see how sensitive the test was to change. The authors used rigorous statistical tests to check that their findings were sound. They had to adjust the score in some respects and the final version of the Dutch QOLHEQ gave a maximum of 89 points made up of 21 for symptoms, 24 each for emotions and functioning and 20 for treatment. They conclude that the final version is valid, reproducible and responsive. The authors estimate that an improvement of at least 15 points represents a genuine improvement for Dutch patients. Linked Article: Oosterhaven et al. Br J Dermatol 2020; 183:86–95. Volume183, Issue1July 2020Pages e11-e11 RelatedInformation

Once-Daily Polymeric Tazarotene 0.045% Lotion for Moderate-to-Severe Acne: Pooled Phase 3 Analysis by Sex.

Background: Two identical phase 3 randomized, double-blind, vehicle-controlled, 12-week studies (NCT03168321 and NCT03168334) demonstrated the efficacy and safety of tazarotene 0.045% lotion in participants with moderate-to-severe acne. Data from these studies were pooled and analyzed post hoc to evaluate outcomes by sex. Methods: Patients aged ≥9 years with moderate-to-severe acne (score 3 or 4 on the Evaluator's Global Severity Score [EGSS]) were randomized (1:1) to once-daily tazarotene 0.045% lotion or vehicle lotion for 12 weeks. Outcomes comprised inflammatory/noninflammatory lesion counts, treatment success (proportion of participants achieving ≥2-grade reduction from baseline in EGSS and score of 0 [“clear”] or 1 [“almost clear”]), and treatment-emergent adverse events (TEAEs). Results: A total of 1,064 females and 550 males were included in this analysis. For both sexes, least-squares mean percent changes from baseline to week 12 in lesion counts were significantly greater with tazarotene 0.045% lotion versus vehicle (inflammatory: females, -60.1% vs -52.1%; males, -53.6% vs -39.8%; noninflammatory: females, -57.6% vs -44.9%; males, -52.9% vs -36.5%; P<0.001, all). The percentage of participants achieving treatment success at week 12 was also significantly higher with tazarotene 0.045% lotion versus vehicle in females and males (P<0.001, both). Compared with tazarotene-treated males, tazarotene-treated females had significantly greater changes from baseline in inflammatory and noninflammatory lesions and a greater proportion achieved treatment success at week 12 (P<0.05, all). TEAE rates were similar between tazarotene- and vehicle-treated males; rates were higher for tazarotene-treated females than vehicle-treated females. Conclusions: Tazarotene 0.045% lotion was efficacious and well tolerated in the treatment of moderate-to-severe acne in female and male participants. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5249

Immunosuppressive treatment in diffuse cutaneous systemic sclerosis is associated with an improved composite response index (CRISS)

BackgroundOutcomes of therapeutic studies in diffuse cutaneous systemic sclerosis (dcSSc) have mainly been measured for specific organs, particularly the skin and lungs. A new composite response index in dcSSc (CRISS) has been developed for clinical trials. The goal of this study was to determine whether, in an observational dcSSc cohort, immunosuppression was associated with global disease improvement measured with the CRISS.MethodsWe conducted a retrospective cohort study in a multi-centered SSc registry comparing 47 patients newly exposed to immunosuppression for ≥ 1 year to 254 unexposed patients. Inverse probability of treatment weighting (IPTW) was performed to create comparable exposed and unexposed groups by balancing for age, sex, disease duration, modified Rodnan skin score (mRSS), forced vital capacity, patient and physician global assessments, and Health Assessment Questionnaire score. A CRISS score ≥ 0.6 at 1 year was defined as improvement.ResultsExposed patients had shorter disease duration (5.5 versus 11.7 years, p < 0.01), more interstitial lung disease (67.4% versus 40.3%, p < 0.01), and worse physician global severity scores (4.2 versus 2.5 points, p < 0.01) compared to unexposed patients. Improvement in CRISS scores was more common in exposed patients after IPTW (odds ratio 1.85, 95% confidence interval 1.11, 3.09). Of the individual CRISS variables, only mean patient global assessment scores were significantly better among exposed than unexposed patients (− 0.4 versus 0 points, p = 0.03) while other variables including mRSS were similar.ConclusionUsing a composite response measure, immunosuppression was associated with better outcomes at 1 year in a dcSSc cohort. These results provide real-world data that align with clinical trials to support our current use of immunosuppression.

Novel Polymeric Tazarotene 0.045% Lotion for Moderate-to-Severe Acne: Pooled Phase 3 Analysis by Race/Ethnicity

Background: Acne vulgaris and inflammation-associated sequelae are highly prevalent in black and Hispanic populations. In a phase 2 study, a novel polymeric emulsion formulation of tazarotene 0.045% lotion had relatively fewer adverse events than tazarotene 0.1% cream, but with comparable efficacy. The objective was to evaluate tazarotene 0.045% lotion by race and ethnicity in the pivotal trials. Methods: In two phase 3, double-blind, 12-week studies (NCT03168334; NCT03168321), participants with moderate-to-severe acne were randomized 1:1 to tazarotene 0.045% lotion or vehicle lotion (N=1,614). This pooled, post hoc analysis included subsets of participants that self-identified as white (n=1191) or black (n=262) and Hispanic (n=352) or non-Hispanic (n=1262). Coprimary endpoints were inflammatory/noninflammatory lesion counts and treatment success (defined as at least a 2-grade reduction from baseline in Evaluator's Global Severity Score and a score of 'clear' or 'almost clear'). Treatment-emergent adverse events (TEAEs) and cutaneous safety and tolerability were evaluated. Results: At week 12, tazarotene 0.045% lotion led to significantly greater percent reductions in inflammatory and noninflammatory lesions compared with vehicle in white, Hispanic, and non-Hispanic participants (P<0.05, all). Black participants had significantly greater reductions in noninflammatory lesions following treatment with tazarotene 0.045% versus vehicle (P<0.05). Treatment success rates in all subpopulations were higher with tazarotene 0.045% lotion (29.4-34.1%) versus vehicle (16.4-23.1%). TEAE rates were similar across tazarotene-treated groups and most were mild-to-moderate in severity. The incidence of hyperpigmentation decreased in black tazarotene-treated participants from baseline to week 12. Conclusions: Tazarotene 0.045% lotion demonstrated efficacy and was well tolerated across racial and ethnic subpopulations in this pooled analysis. J Drugs Dermatol. 2020;19(7) doi:10.36849/JDD.2020.5125.

M23. ALTERATION OF REGIONAL CEREBRAL BLOOD FLOW MEASURED BY ARTERIAL SPIN LABELING IN PATIENTS WITH TREATMENT-RESISTANT SCHIZOPHRENIA

BackgroundApproximately 30% of patients with schizophrenia do not respond to antipsychotics, which is called treatment-resistant schizophrenia (TRS). A recent systematic review showed decreased regional cerebral blood flow (rCBF) in the cerebral cortex and increased rCBF in the putamen in patients with schizophrenia. However, to date, no study has examined rCBF using arterial spin labeling (ASL) in patients with TRS. Thus, we compared rCBF between patients with TRS and those with non-TRS to investigate neural basis of this condition.MethodsWe acquired whole-brain rCBF measurements using 1.5T magnetic resonance imaging (MRI) with pseudo-continuous ASL in those with TRS and non-TRS. TRS was defined as 1) a Clinical Global Impression Severity (CGI-S) score of ≧ 4 (moderate) and 2) a score of ≧ 4 (moderate) on two Positive and Negative Syndrome Scale (PANSS) positive symptom items after optimal antipsychotic treatment. Non-TRS was defined as 1) a CGI-S score of ≦3, 2) scores of ≦ 3 on all positive symptom items of the PANSS, and 3) no symptomatic relapse during the previous 3 months. Optimal antipsychotic treatment was defined as ≧ 6 consecutive weeks with ≧ 400 mg of chlorpromazine (CPZ) equivalent daily dose antipsychotic treatment. The rCBF maps were subsequently derived from the proton-density-weighted reference images. Group differences in rCBF between the two groups (non-TRS vs. TRS) were tested using two sample t-test with age, gender, and PANSS positive scores as covariates. Multiple comparisons were corrected using familywise error (FWE) method with a significance threshold of P <.05.ResultsA total of 32 participants were included (13 TRS [6 females, age= 41.2±9.8, PANSS=80.3±9.7] and 19 non-TRS [6 females, age= 40.6±11.9, PANSS=58.9±10.0]). rCBF in the cerebellum was increased in the TRS group compared with the non-TRS group. In addition, there are inverse correlation between rCBF in the cerebellum and PANSS positive score in the non-TRS group.DiscussionThese preliminary results suggest that perfusion in the cerebellum may be implicated in the pathophysiology of TRS. This study will continue to enroll participants (our target sample is 30/each group). To identify the abnormal rCBF in patients with TRS will facilitate elucidating the pathophysiology of TRS and pave a way of developing novel treatment of this difficult-to-treat population.

New Polymeric Once-Daily Tazarotene 0.045% Lotion Formulation for Moderate-to-Severe Acne: Pooled Phase 3 Pediatric Analysis

Background: Acne vulgaris affects approximately 85% of adolescents. Topical tazarotene is efficacious and safe for acne treatment but irritation limits its use. The objective was to evaluate efficacy, safety, and tolerability of a new tazarotene 0.045% lotion formulation in patients aged 10-13 and 14-17 years with moderate-to-severe acne. Methods: In two phase 3, double-blind, vehicle-controlled 12-week studies, patients with moderate-to-severe acne (N=1,614) were randomized (1:1) to receive tazarotene 0.045% lotion or vehicle once-daily. Efficacy assessments included changes from baseline in inflammatory/noninflammatory lesions and treatment success (≥2-grade reduction in Evaluator's Global Severity Score [EGSS] and a clear/almost clear score). Quality of life (QoL) and adverse events (AEs) were also assessed. Results: Patients aged 10-13 years (n=136) and 14-17 years (n=548) were pooled. At week 12, mean percent reductions in inflammatory and noninflammatory lesion counts were significantly greater with tazarotene versus vehicle in both age groups (least-squares mean inflammatory 10-13 years: -55.6 vs -37.0%; 14-17 years: -53.3 vs -41.2%; noninflammatory 10-13 years: -47.7 vs -28.2%; 14-17 years: -52.7 vs -32.9%; P<0.01 all). More patients achieved treatment success with tazarotene versus vehicle in both age groups (P<0.05, both). There were no significant differences between tazarotene-treated age groups in lesion counts or treatment success. Acne-QoL scores at week 12 in both age groups were numerically improved in most domains with tazarotene 0.045% lotion versus vehicle. Most treatment-emergent AEs with tazarotene or vehicle were of mild or moderate severity in both age groups. Conclusions: Tazarotene 0.045% lotion was efficacious and well tolerated in pediatric patients with moderate-to-severe acne. J Drugs Dermatol. 2020;19(6): doi:10.36849/JDD.2020.4959THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.

Impact of Sleep Bruxism on Oral Health-Related Quality of Life.

To determine the prevalence of possible tooth grinding (TG) and possible sleep bruxism (SB) and to examine their impacts on oral health-related quality of life (OHRQoL) among Asian adults. A total of 3,072 subjects (18 to 65 years of age) from 12 dental centers were invited to complete a self-administered questionnaire on TG/SB and OHRQoL, and 2,417 were included in the study. Participants were subsequently categorized into three groups (no TG/SB, possible TG, and possible SB) based on the International Classification of Sleep Disorders. The 14-item Oral Health Impact Profile (OHIP-14) severity, extent, and prevalence scores were subsequently computed and compared. Data were examined using Kruskal-Wallis and Mann-Whitney U tests, Spearman correlation, and univariate regression analysis (P < .05). Of the 2,417 subjects (mean age 24.79 ± 7.49 years), 42.82% reported either possible TG (n = 921; 38.11%) or possible SB (n = 114; 4.72%). Significant differences in global and domain OHIP-14 scores were found between the groups, except for the extent scores in functional limitation and physical disability. Mean global severity scores of the possible SB group (9.36 ± 9.45) were 1.5- and 2.2-fold larger than the possible TG (6.39 ± 7.61) and no TG/SB (4.22 ± 6.15) groups, respectively. A significant but weak correlation (r = 0.14 to 0.19) was found between the number of positive responses for TG/SB and OHIP-14 severity scores. A high prevalence of possible TG and SB was found among the Asian cohort studied. Possible TG and SB were significantly associated with poorer OHRQoL. The physical pain, psychologic discomfort, and psychologic disability domains were most influenced by TG/SB. More epidemiologic studies on the functional, physical, and psychosocial influences of SB are required.

Efficacy of Parent-Delivered, Home-Based Therapy for Tics

BackgroundAlthough behavioral therapy is an effective approach to reduce tics in children and adults, there is an insufficient availability and accessibility of behavioral therapy in the community. ObjectiveThe goal of the study was to test the clinical efficacy of home-based, parent-provided behavioral therapy in children with Tourette syndrome aged seven to 13 years. MethodAn instructional habit reversal training-based video and guide was developed for use by parents. Eligible families, in this 10-week study, were enrolled in either a home-based therapy (DVD) group (received disk and written instructions) or an in-person therapist group (had scheduled visits with the therapist). Outcome scales included the Yale Global Tic Severity Scale, both the total Tic Severity Score and total Global Severity Score, and the parent report of Clinical Global Impressions of Improvement. ResultsForty-four children (mean age = 10.21 ± 1.69 years) were enrolled into either the DVD (n = 33) or in-person therapist (n = 11) groups. Eighteen completed the study—eight in the DVD and 10 in the in-person therapist group. Outcome measures showed significant reductions in Yale Global Tic Severity Scale change ratios: mean improvement on the Tic Severity Score was DVD 32.4% (P < 0.001) and in-person therapist 26.6% (P = 0.01); and for the Global Severity Score, DVD 33.7% (P < 0.001) and in-person therapist 26.7% (P < 0.001). ConclusionsHome-based, parent-administered habit reversal training behavioral therapy is efficacious for reducing tics in children. Telephone contacts early in the DVD treatment course might reduce the number of dropouts.

Novel Polymeric Lotion Formulation of Once-Daily Tazarotene (0.045%) for Moderate-to-Severe Acne: Pooled Phase 3 Analysis.

Background: As current tazarotene formulations indicated for acne (0.1%) can cause irritation, a new tazarotene 0.045% lotion formu-lation was developed using polymeric emulsion technology. The objective was to assess efficacy, safety, and tolerability of tazarotene 0.045% lotion in patients with moderate-to-severe acne in a pooled analysis of data from two identical phase 3, double-blind, random-ized, vehicle-controlled 12-week clinical studies. Methods: Patients aged ≥9 years with moderate-to-severe acne were randomized (1:1) to tazarotene 0.045% lotion or vehicle lotion applied once daily. Inflammatory and noninflammatory lesion counts and Evaluator's Global Severity Score (EGSS) were assessed. Treatment success was defined as a ≥2-grade improvement in EGSS and a score of 'clear'/'almost clear'. Adverse events (AEs) and cutaneous safety and tolerability were also assessed. Results: In total, 1614 patients (mean age: 20.5 years) were randomized to tazarotene 0.045% lotion (n=799) or vehicle (n=815). At week 12, tazarotene 0.045% lotion demonstrated statistically significant superiority versus vehicle in reducing inflammatory and non-inflammatory lesion counts (least-squares mean percent changes from baseline: inflammatory, -57.9% vs -47.8% [P<0.001]; noninflam-matory, -56.0% vs -42.0% [P<0.001]). Treatment success at week 12 was also greater with tazarotene 0.045% lotion versus vehicle (30.4% vs 17.9%; P<0.001). The most frequent treatment-emergent AEs related to tazarotene treatment were application site pain (5.3%), dryness (3.6%), and exfoliation (2.1%). Conclusions: The new tazarotene 0.045% lotion formulated with polymeric emulsion technology demonstrated statistically signifi-cantly superior efficacy versus vehicle and was well tolerated in pediatric and adult patients with moderate-to-severe acne in this pooled analysis of 2 vehicle-controlled phase 3 studies. J Drugs Dermatol. 2020;19(3):272-279. doi:10.36849/JDD.2020.4869.

Safety and efficacy of taurine as an add-on treatment for tics in youngsters.

The pathophysiological model of tics generally describes disruption of γ-aminobutyric acid transmission, and taurine is found to be an agonist of γ-aminobutyric acid receptors.The study aimed to evaluate the safety and efficacy of taurine as an add-on treatment for tics. Four hundred and four youngsters with tic disorders were randomly assigned to 12weeks of either oral taurine or placebo. The Yale Global Tic Severity Scale was used to measure tic severity. The primary outcome measure was global severity scores reduced by more than 60% compared with baseline scores. Three hundred and eighty-two patients were successfully treated. At week 4, no significant differences were found in the treatment effect and the total occurrence of adverse drug reactions between the taurine and placebo groups. At week 12, the proportion of significant improvement in tics was significantly higher in the taurine group than the placebo group (53.4% with taurine versus 34.5% without taurine; relative risk1.546; P<0.001), and no group differences were found in the total occurrence of adverse drug reactions. Taurine is safe and effective for tics.

Impact of a Terrorist Attack on the Mental Health of Directly Exposed French Adolescents: Study Protocol for the First Step of the AVAL Cohort Study.

Background: Several terrorist attacks have recently taken place in France and Europe. Various studies have shown a high prevalence of Post-Traumatic Stress Disorder (PTSD) and other psychiatric disorders among the victims of these attacks. Nevertheless, research in this field is scarce and no cohort study has been conducted yet to evaluate the impact of a terrorist attack on teenagers directly exposed to this type of events. Therefore, we decided to work on the AVAL (Adolescents Victimes de l’Attentat de Londres) cohort study in order to measure the psycho-traumatic impact of this attack and to describe these adolescents’ health care pathways.Material and method: The 53 students of a French high school who were directly exposed (criterion A1 of PTSD in DSM-5) to the terrorist attack perpetrated in London on March 22, 2017 constitute the target population of this monocentric cross-sectional observational study. We decided not to include the three students who were physically wounded and, therefore, didn’t have the same sensorial exposition. The primary endpoint will be the prevalence of PTSD 12 to 15 months after the attack, measured by the PCL-5 (Post-traumatic stress disorder Check-List for DSM-5) global severity score: the diagnosis of PTSD will be retained when the score is > 32. We will also use an extensive battery of clinical tests to assess the prevalence of anxiety disorders, mood disorders, sleep disorders, addictions, suicide risk, and alterations in social, family, and school functioning 12 to 15 months after the attack. We will also describe these adolescents’ health care pathways since the attack and collect data from the clinical evaluation performed during the initial intervention of the medico-psychological emergency cell within 10 days after the attack.Discussion: The findings of this study are intended to provide epidemiological data about the psycho-traumatic impact of a terrorist attack on the mental health of directly exposed adolescents and to describe these adolescents’ health care pathways, thus contributing to improve the immediate, post-immediate, and delayed response strategies after a major psycho-traumatic event involving adolescents (and in particular after terrorist attacks), as well as the identification and psychiatric care of the young survivors requiring specialized care.Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT03493243.Ethics and Dissemination: The regional ethics committee (Comité de Protection des Personnes Ouest IV—Nantes) approved the study protocol (Reference 10/18_3). All participants (and their legal guardians, for minors) must sign the informed consent to participate. The protocol was presented at the French congress of psychiatry in Nantes (France) in November 2018. After study completion, the results will be published and detailed in Marion Grenon’s MD thesis in psychiatry.

Switching strategies forantipsychotic monotherapy inschizophrenia: amulti-center cohort study ofaripiprazole.

Changing antipsychotics of patients with chronic schizophrenia involves several risks. Switching to aripiprazole is especially difficult. We investigated switching methods and related factors for successful switching patients with chronic schizophrenia to aripiprazole. This study was a multi-center historical cohort study and approved by the research ethics committee of Okayama University Hospital and Okayama Psychiatric Medical Center. We compared survival proportions of 178 chronic schizophrenia patients who continued aripiprazole monotherapy for 6months after non-direct switching (add-on switching (n = 45), cross switching (n = 62)) or direct switching (n = 71). We adjusted possible confounders using a Cox proportional hazards model. Of patients with chronic schizophrenia, 56.7% (101/178) were switched to aripiprazole monotherapy, and 55.0% (98/178) showed improvement in symptoms as demonstrated by the Clinical Global Impression Severity score. Kaplan-Meier survival curves showed that non-direct switching had a higher survival proportion than direct switching (log-rank test, p = 0.012). Even after adjusting for several variables using a Cox proportional hazards model, add-on switching had a significantly lower hazard at 6months than direct switching (hazard ratio 0.42, 95% confidence interval 0.21-0.82, P= 0.01). In cases of switching to aripiprazole for psychiatric symptoms, non-direct switching had a lower hazard than direct switching (hazard ratio 0.41, 95% confidence interval 0.21-0.81, P= 0.01) but was not significant for adverse reaction. When aripiprazole was switched from olanzapine, add-on switch showed the lowest hazard ratio for continuation (hazard ratio 0.29, 95% confidence interval 0.07-1.11, P= 0.07). Flexibility in strategies when switching to aripiprazole may induce a better outcome for patients with chronic schizophrenia.

Treatment of brittle nail with a hydroxypropyl chitosan-based lacquer, alone or in combination with oral biotin: A randomized, assessor-blinded trial.

We evaluated in a randomized, assessor-blinded, study the efficacy of a hydroxypropyl chitosan-based nail lacquer (HPC-NL) alone or in combination with oral biotin (HPC-NL + B) in the treatment of brittle nail syndrome (BNS). Fifty subjects (21 men; mean age 64 years) with BNS were enrolled. Twenty-six were randomly assigned to HPC-NL and 24 to the HPC-NL and biotin, 10 mg/daily (+B). Topical and oral treatments lasted for 4 consecutive months. The primary outcome was the evolution of the Onychodystrophy Global Severity Score (OGSS) assessing nail dystrophy, lamellar and longitudinal splitting, dyschromia, and pitting. At baseline, the OGSS, mean (SD), was 8.4 (2.1) in the HPC-NL group and 11.8 (2.3) in the HPC-NL + B group. The OGSS was significantly reduced during treatments in both groups. At Month 4, OGSS was reduced by 57% (HPC-NL) and 62% (HPC-NL + B). At the end of study period, the percentage of subjects with an OGSS reduction of ≥50% in comparison with baseline was 53% in the HPC-NL group and 80% in the HPC-NL + B group (p = .05). Both treatments were well tolerated. In subjects with BNS, HPC-NL alone is associated with a clinically relevant improvement of nail appearance. The combination of HPC-NL and oral biotin is associated with further clinical improvement.

Aims, Study Design, and Enrollment Results From the Assessing Predictors of Infant Respiratory Syncytial Virus Effects and Severity Study.

BackgroundThe majority of infants hospitalized with primary respiratory syncytial virus (RSV) infection have no obvious risk factors for severe disease.ObjectiveThe aim of this study (Assessing Predictors of Infant RSV Effects and Severity, AsPIRES) was to identify factors associated with severe disease in full-term healthy infants younger than 10 months with primary RSV infection.MethodsRSV infected infants were enrolled from 3 cohorts during consecutive winters from August 2012 to April 2016 in Rochester, New York. A birth cohort was prospectively enrolled and followed through their first winter for development of RSV infection. An outpatient supplemental cohort was enrolled in the emergency department or pediatric offices, and a hospital cohort was enrolled on admission with RSV infection. RSV was diagnosed by reverse transcriptase-polymerase chain reaction. Demographic and clinical data were recorded and samples collected for assays: buccal swab (cytomegalovirus polymerase chain reaction, PCR), nasal swab (RSV qualitative PCR, complete viral gene sequence, 16S ribosomal ribonucleic acid [RNA] amplicon microbiota analysis), nasal wash (chemokine and cytokine assays), nasal brush (nasal respiratory epithelial cell gene expression using RNA sequencing [RNAseq]), and 2 to 3 ml of heparinized blood (flow cytometry, RNAseq analysis of purified cluster of differentiation [CD]4+, CD8+, B cells and natural killer cells, and RSV-specific antibody). Cord blood (RSV-specific antibody) was also collected for the birth cohort. Univariate and multivariate logistic regression will be used for analysis of data using a continuous Global Respiratory Severity Score (GRSS) as the outcome variable. Novel statistical methods will be developed for integration of the large complex datasets.ResultsA total of 453 infants were enrolled into the 3 cohorts; 226 in the birth cohort, 60 in the supplemental cohort, and 78 in the hospital cohort. A total of 126 birth cohort infants remained in the study and were evaluated for 150 respiratory illnesses. Of the 60 RSV positive infants in the supplemental cohort, 42 completed the study, whereas all 78 of the RSV positive hospital cohort infants completed the study. A GRSS was calculated for each RSV-infected infant and is being used to analyze each of the complex datasets by correlation with disease severity in univariate and multivariate methods.ConclusionsThe AsPIRES study will provide insights into the complex pathogenesis of RSV infection in healthy full-term infants with primary RSV infection. The analysis will allow assessment of multiple factors potentially influencing the severity of RSV infection including the level of RSV specific antibodies, the innate immune response of nasal epithelial cells, the adaptive response by various lymphocyte subsets, the resident airway microbiota, and viral factors. Results of this study will inform disease interventions such as vaccines and antiviral therapies.

Combination of the Centre for International Blood and Marrow Transplant Registry Risk Score and the Global Severity Score Enhances Prognostic Risk Stratification in Patients Receiving Frontline Therapy for Chronic Graft-versus-Host Disease

The Centre for International Blood and Marrow Transplant Registry (CIBMTR) score has been shown to be prognostic for overall survival (OS) and nonrelapse mortality (NRM) but has been shown in several single-center studies to classify a large proportion of patients with chronic graft-versus-host disease (cGVHD) in the lower risk groups (RG1 to RG2), thereby limiting its prognostic utility for those patients. We evaluate the CIBMTR score, the Global Severity Score (GSS), and a novel risk score developed to improve on the limitations of the CIBMTR with respect to clinically relevant outcomes, including failure-free survival (FFS), in patients receiving frontline systemic treatment for cGVHD. We identified 277 patients between 2002 and 2012 at the Princess Margaret Cancer Centre in Toronto, Canada, who developed cGVHD and were treated with at least 1 line of systemic therapy. cGVHD was graded by GSS, and patients were stratified by CIBMTR. We evaluated OS, NRM, relapse, and FFS within GSS grade groups, as well as CIBMTR RGs, and used a novel prognostic risk score. The median FFS duration was 164 days in the severe GSS group versus 238 days in the moderate-grade group and 304 days in mild-grade group (P= .001). The median FFS duration was 501 days in CIBMTR RG1 versus 291 days in RG2 and 166 days in RG3 to RG6 (P = .003). A novel risk score combining the GSS and CIBMTR scores was prognostic of OS, NRM, and FFS and was able to subdivide patients with cGVHD in CIBMTR RG1 to RG2 into distinct prognostic risk categories. The CIBMTR risk score and the GSS are well correlated with FFS, OS, and NRM following frontline systemic treatment for cGVHD. A new risk score model combining the CIBMTR risk score and the GSS could enhance risk stratification in the lower CIBMTR risk groups.