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2021 ◽  
pp. 108705472110442
Author(s):  
Erik Seesjärvi ◽  
Jasmin Puhakka ◽  
Eeva T. Aronen ◽  
Jari Lipsanen ◽  
Minna Mannerkoski ◽  
...  

Objective: To quantify goal-directed behavior and ADHD symptoms in naturalistic conditions, we developed a virtual reality task, EPELI (Executive Performance in Everyday LIving), and tested its predictive, discriminant and concurrent validity. Method: We collected EPELI data, conventional neuropsychological task data, and parent-ratings of executive problems and symptoms in 38 ADHD children and 38 typically developing controls. Results: EPELI showed predictive validity as the ADHD group exhibited higher percentage of irrelevant actions reflecting lower attentional-executive efficacy and more controller movements and total game actions, both indicative of hyperactivity-impulsivity. Further, the five combined EPELI measures showed excellent discriminant validity (area under curve 88 %), while the correlations of the EPELI efficacy measure with parent-rated executive problems (r = .57) and ADHD symptoms (r = .55) pointed to its concurrent validity. Conclusion: We provide a proof-of-concept validation for a new virtual reality tool for ecologically valid assessment of ADHD symptoms.


2021 ◽  
pp. svn-2021-001070
Author(s):  
Nawaf Yassi ◽  
Henry Zhao ◽  
Leonid Churilov ◽  
Bruce C V Campbell ◽  
Teddy Wu ◽  
...  

RationaleHaematoma growth is common early after intracerebral haemorrhage (ICH), and is a key determinant of outcome. Tranexamic acid, a widely available antifibrinolytic agent with an excellent safety profile, may reduce haematoma growth.Methods and designStopping intracerebral haemorrhage with tranexamic acid for hyperacute onset presentation including mobile stroke units (STOP-MSU) is a phase II double-blind, randomised, placebo-controlled, multicentre, international investigator-led clinical trial, conducted within the estimand statistical framework.HypothesisIn patients with spontaneous ICH, treatment with tranexamic acid within 2 hours of onset will reduce haematoma expansion compared with placebo.Sample size estimatesA sample size of 180 patients (90 in each arm) would be required to detect an absolute difference in the primary outcome of 20% (placebo 39% vs treatment 19%) under a two-tailed significance level of 0.05. An adaptive sample size re-estimation based on the outcomes of 144 patients will allow a possible increase to a prespecified maximum of 326 patients.InterventionParticipants will receive 1 g intravenous tranexamic acid over 10 min, followed by 1 g intravenous tranexamic acid over 8 hours; or matching placebo.Primary efficacy measureThe primary efficacy measure is the proportion of patients with haematoma growth by 24±6 hours, defined as either ≥33% relative increase or ≥6 mL absolute increase in haematoma volume between baseline and follow-up CT scan.DiscussionWe describe the rationale and protocol of STOP-MSU, a phase II trial of tranexamic acid in patients with ICH within 2 hours from onset, based in participating mobile stroke units and emergency departments.


Author(s):  
Roberto Caporali ◽  
Roberto Ravasio ◽  
Paola Raimondo ◽  
Fausto Salaffi

Purpose: The objective of this economic evaluation was to compare the cost per responder between upadacitinib and abatacept (intravenous [iv] or subcutaneous [sc]) in patients with moderate-to-severe Rheumatoid Arthritis (RA) in Italy. Methods: The clinical efficacy was assessed based on SELECT-CHOICE study results. The clinical efficacy of upadacitinib and abatacept (iv or sc) was measured by Clinical Remission (CR), Low Disease Activity (LDA) and American College of Rheumatology response (ACR20, 50 and 70). The treatment cost was based on the number of administrations dispensed at 12 or 24 weeks. The cost per responder was adopted as a cost-effectiveness indicator. Results: Independent of the clinical efficacy measure used and the duration of treatment considered, the cost per responder was consistently lower for upadacitinib compared to abatacept (iv or sc) across all clinical measures. For example, considering the CR at 24 weeks, the cost per responder for upadacitinib was € 9,417 compared to € 17,817 for abatacept sc or to € 23,110 for abatacept iv. The differences in the cost per responder between upadacitinib and abatacept (iv or sc) increased when higher ACR response levels were considered. Conclusions: These results suggested that upadacitinib is a cost-effectiveness option compared to abatacept (iv or sc) from the perspective of the Italian National Health Service in patients with moderate-to-severe Rheumatoid Arthritis in Italy.


2021 ◽  
Author(s):  
Erik Seesjärvi ◽  
Jasmin Puhakka ◽  
Eeva T. Aronen ◽  
Jari Lipsanen ◽  
Minna Mannerkoski ◽  
...  

Objective: In the assessment of attention deficit hyperactivity disorder (ADHD) there is a need for methods that would reflect ADHD symptoms in naturalistic yet controlled situations objectively. Method: We developed a novel virtual reality task, EPELI (Executive Performance in Everyday LIving), and used it to quantify goal-directed behavior in ADHD children (n = 38) and typically developing controls (n = 38) in everyday home situations. Results: The ADHD group exhibited higher percentage of irrelevant actions out of all actions, reflecting lower attentional-executive efficacy, and more controller movements and more total game actions, both indicative of hyperactivity-impulsivity. Five main EPELI measures combined exhibited excellent discriminatory ability, with area under curve being 88 %. The efficacy measure of EPELI was strongly correlated with parent evaluations of everyday executive problems (r = .57) and ADHD symptoms (r = .55). Conclusion: Virtual reality assessment can successfully quantify ADHD symptoms in a rich naturalistic context.


2021 ◽  
Vol 13 (2) ◽  
pp. 19
Author(s):  
Mirvat Y. Amirah ◽  
Khaldoun A. Najadat ◽  
Sara J. Mubarak

This study aimed to examine the perceived self-efficacy of the resource room teachers for the distance learning experience in the capital Amman, Jordan in terms of some variables. To achieve this goal, 124 female resource teachers in government schools in the capital governorate were selected. The perceived self-efficacy measure was used to collect data. It is a valid and reliable measure that contains 25 items. The results showed that the level of perceived self-efficacy of the resource room teachers for the distance learning experience was moderate, as the mean of the overall tool was (3.16) with a moderate evaluation score. Table (3) shown that the averages of the tool's items ranged between (2.15-4.07). These averages didn't indicate statistically significant differences at (α≤0.05) for the variables: specialization, teacher's educational level, and number of students who receive service in the room. The data showed statistically significant differences at the (α≤0.05) for teacher's age variable in favor of the younger group. Also, the data showed statistically significant differences at the (α≤0.05) for the variable years of experience in favor of the least experience, less than 5 years.


2021 ◽  
Vol 9 (1) ◽  
pp. 87-96
Author(s):  
Patil Vishwanath Malagonda ◽  
Vikas S. Minchekar

Aggressive behavior in sports and group performance is critical in today's scenario. Self-efficacy can play a crucial role in aggressive behavior. Hence, to test this assumption study was undertaken to assess the association between self-efficacy and aggression. It was hypothesized that self-efficacy and aggression are positively and significantly related to each other. This study's sample contained 80 students, and they were recruited from Dr. Ghali College, Gadhinglaj. The sampling technique was non probability sampling in which everyone doesn’t have the same chance for being chosen as a sampling. This study administered self-efficacy measure using the scale by G. P. Mathur and Dr. Raj Kumari Bhatnagar and aggression scale by G. P. Mathur and Dr. Raj Kumari Bhatnagar to 40 male and 40 female college students. Obtained data were analyzed by Student t-test and PPMCC test. Results revealed that there is a significant sex difference in self-efficacy and aggression. Moreover, the association between self-efficacy and aggression among college students was also found significant.


SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A195-A195
Author(s):  
Nancy Foldvary-Schaefer ◽  
Isabelle Arnulf ◽  
Karel Šonka ◽  
Patricia Chandler ◽  
Abby Chen ◽  
...  

Abstract Introduction Idiopathic hypersomnia (IH) is a rare central hypersomnolence disorder with no approved treatment, characterized by excessive daytime sleepiness, prolonged sleep time, and sleep inertia. The Idiopathic Hypersomnia Severity Scale (IHSS) is a 14-item, self-reported questionnaire that assesses severity of IH symptoms, including symptoms related to night/inertia (component I) and day/performance (component II). Individual IHSS items measure symptom frequency, intensity, and consequences using 3- or 4-point Likert scales, yielding a total score (range, 0–50), comprising component I (range, 0–16) and component II (range, 0–34). Higher scores indicate worse symptoms. In a recent clinical trial of the efficacy and safety of lower-sodium oxybate (LXB; Xywav™) for the treatment of IH, the IHSS was a key efficacy measure. Methods Eligible participants 18–75 years of age with IH began LXB treatment with an open-label treatment titration and optimization period (OLTTOP; 10–14 weeks), followed by a 2-week stable-dose period (SDP). Participants were randomized to placebo or continued LXB treatment during a 2-week, double-blind, randomized withdrawal period (DBRWP). The IHSS was completed at baseline, during OLTTOP (weeks 1, 4, and 8), and at the end of OLTTOP, SDP, and DBRWP. Change in IHSS total score from SDP to DBRWP was a key secondary endpoint. Results The efficacy population included 115 participants (mean±SD age, 41±14 years; 71% female). At baseline and the end of SDP, respectively, mean±SD IHSS scores were 31.6±8.3 and 15.3±8.5 for total score, 10.3±3.6 and 5.4±2.8 for component I (night/inertia), and 21.2±5.8 and 9.9±6.5 for component II (day/performance). Worsening from SDP to DBRWP was observed in patients randomized to placebo compared with LXB in IHSS total scores (estimated median difference [95% CI], −12.0 [−15.0, −8.0]; significant P<0.0001), component I scores (LS mean difference [95% CI], −3.9 [−4.9, −2.9]; nominal P<0.0001), and component II scores (LS mean difference [95% CI], −7.8 [−9.6, −5.9]; nominal P<0.0001). Results on all individual IHSS items reflected an improvement with LXB treatment over time during OLTTOP, which remained consistent during SDP. Conclusion These results support the efficacy of LXB for the treatment of IH symptoms, as assessed with the IHSS. Support (if any) Jazz Pharmaceuticals


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