scholarly journals Study design of a prospective, open-label study comparing increased infusion parameters of a 20% subcutaneous immunoglobulin (IgPro20) in patients with primary immunodeficiency

2019 ◽  
Author(s):  
Mikhail Rojavin ◽  
Jutta Hofmann ◽  
Michaela Praus
Keyword(s):  
United States ◽  
Injection Site ◽  
Primary Immunodeficiency ◽  
Flow Rate ◽  
Infusion Pump ◽  
The United States ◽  
Responder Rate ◽  
Prospective Clinical Study ◽  
Flow Rates ◽  
Study Results

Abstract Background: Immunoglobulin G (IgG) replacement therapy can be administered subcutaneously (SCIG) using an infusion pump or by manual push. Both methods have shown similar serum IgG trough levels for the same total weekly/monthly dose as well as safety and tolerability profiles. The currently approved infusion parameters for the SCIG Hizentra® (IgPro20, CSL Behring, King of Prussia, PA, USA) in primary immunodeficiency (PID) in the United States are volumes of ≤25 mL and flow rates of ≤25 mL/h per injection site. Previously, clinical studies and case reports had demonstrated use of higher infusion parameters than those approved, but safety and tolerability of these have not been systematically evaluated. In the absence of regulatory guidance, we have developed a novel prospective clinical study applying forced upward titration design to evaluate the safety and tolerability of high infusion parameters of IgPro20 in PID patients using pump-assisted and manual push techniques (NCT03033745). Results: A total of 45 patients were planned for inclusion. Primary endpoints were defined as the proportion of patients successfully infusing certain infusion parameters (responder rate). The study included three cohorts (n=15 planned per group): 1) Pump-assisted Volume Cohort with weekly infusions at volumes of 25, 40 and 50 mL per injection site; 2) Pump-assisted Flow Rate Cohort with weekly infusions at flow rates of 25, 50, 75 and 100 mL/h per injection site, and 3) Manual Push Flow Rate Cohort with 2 to 7 infusions at flow rates 30, 60 and 120 mL/h per injection site. Each infusion parameter level was tested for 4 weeks, after which those who successfully infused at the current level (responders) were switched to the next level. Responder rate, safety and tolerability were assessed. Study results will be available in early 2020. Conclusions: This study applied a novel and rigorous prospective evaluation of individual safety and tolerability levels of pump-assisted and manual push SCIG at higher infusion parameters than currently approved in the United States and demonstrated their safety and tolerability.

Measurement of Perceived Interpersonal and Societal Anti-Muslim Discrimination in the United States

Assessment ◽  
2020 ◽  
pp. 107319112097338
Author(s):  
Naheed Ahmed
Keyword(s):  
United States ◽  
Online Survey ◽  
Qualitative Data ◽  
High Reliability ◽  
The United States ◽  
Discrimination Index ◽  
Muslim Americans ◽  
Study Results ◽  
Development And Validation ◽  
Component Models

Background: Hate crimes against Muslim Americans have increased exponentially in the past 20 years, but there is currently no scale for measuring perceived anti-Muslim discrimination in the United States. To fill this gap, this study used a mixed-method approach to develop scales for measuring perceived anti-Muslim discrimination. Method: Qualitative data informed the development and validation of the 19-item Societal Anti-Muslim Discrimination Index and the 9-item Interpersonal Anti-Muslim Discrimination Index. Quantitative data ( N = 347) were collected from Muslim Americans using an online survey and used to assess the anti-Muslim indexes. Results: Qualitative data contributed to the refinement scale items. Quantitative results indicated one-component models and modest to high reliability of the Interpersonal Anti-Muslim Discrimination Index (.77) and Societal Anti-Muslim Discrimination Index (.88) scales. Discussion: Study results established the validity of these novel scales for measuring the distinct facets of anti-Muslim discrimination not captured by the Everyday Discrimination Index. These scales will facilitate research on anti-Muslim discrimination and the health implications of this form of religious-based discrimination.

Honesty among lawyers: Moral character, game framing, and honest disclosures in negotiations

2021 ◽  
Author(s):  
Taya R. Cohen ◽  
Erik G Helzer ◽  
Robert Creo
Keyword(s):  
United States ◽  
Moral Character ◽  
The United States ◽  
Law Students ◽  
Study Results ◽  
Cognitive Framing

Lawyers have broad discretion in deciding how honestly to behave when negotiating. We propose that lawyers’ choices about whether to disclose information to correct misimpressions by opposing counsel are guided by their moral character and their cognitive framing of negotiation. To investigate this possibility, we surveyed 215 lawyers from across the United States, examining the degree to which honest disclosure is associated with lawyers’ moral character and their tendency to frame negotiation in game-like terms—a construal of negotiation that we label game framing. We hypothesize that the more that lawyers view negotiation through a game frame—that is, the more they view negotiation as an adversarial context with arbitrary and artificial rules—the less honest they will be in situations in which honest disclosure is not mandated by professional rules of conduct. We further hypothesize that lawyers with higher levels of moral character will apply a game frame to negotiation to a lesser degree than will lawyers with lower levels of moral character, and that honesty when negotiating will be higher when lawyers have higher versus lower levels of moral character. Our study results support these hypotheses. This work suggests that focusing on game-like aspects of negotiation can induce a less moral and ethical mindset. To the extent that teaching law students to “think like a lawyer” encourages them to adopt a game frame of negotiation, we can expect such training to reduce the likelihood of honest disclosure.

scholarly journals Influence of the syringe model on the results of the International Dysphagia Diet Standardisation initiative flow test

Revista CEFAC ◽  
2018 ◽  
Vol 20 (3) ◽  
pp. 382-387 ◽  
Author(s):  
Roberto Oliveira Dantas ◽  
Luciana Oliveira
Keyword(s):  
United States ◽  
Potassium Chloride ◽  
Flow Rate ◽  
Barium Sulfate ◽  
Xanthan Gum ◽  
The United States ◽  
Flow Test ◽  
Food Thickener

ABSTRACT Objective: to investigate whether two different syringes yield different results in the International Dysphagia Diet Standardization Initiative (IDDSI) flow test to evaluate liquid consistency. Methods: two 10-mL syringes (Bencton and Dickinson, manufactured in the United States, and Saldanha Rodrigues, manufactured in Brazil) were compared. Flow rate of water added with food thickener (maltodextrin, xanthan gum and potassium chloride) at three concentrations, and of barium sulfate at three concentrations was measured immediately after preparation and at 8 hours and 24 hours thereafter. Results: flow rate of both water and barium sulfate was higher with the Bencton and Dickinson syringe, with discrepancies between the two syringes in the classification of fluid consistency according to the IDDI framework. Conclusion: in the evaluation of the consistency of liquids by the IDDSI flow test, a Bencton and Dickinson syringe should be used, following the recommendations of the IDDSI group.

scholarly journals The COVID-19 cannabis health study: Results from an epidemiologic assessment of adults who use cannabis for medicinal reasons in the United States

2020 ◽  
pp. 1-11 ◽  
Author(s):  
Denise C. Vidot ◽  
Jessica Y. Islam ◽  
Marlene Camacho-Rivera ◽  
Melissa B. Harrell ◽  
Devika R. Rao ◽  
...  
Keyword(s):  
United States ◽  
The United States ◽  
Health Study ◽  
Study Results

scholarly journals Long-Term Efficacy and Safety of Hizentra® in Patients with Primary Immunodeficiency in Japan, Europe, and the United States: a Review of 7 Phase 3 Trials

2018 ◽  
Vol 38 (8) ◽  
pp. 864-875 ◽  
Author(s):  
Stephen Jolles ◽  
Mikhail A. Rojavin ◽  
John-Philip Lawo ◽  
Robert Nelson ◽  
Richard L. Wasserman ◽  
...  
Keyword(s):  
United States ◽  
Primary Immunodeficiency ◽  
The United States ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Term Efficacy

A Look at the Second International Mathematics Study Results in the U.S.A. and Japan

1987 ◽  
Vol 80 (5) ◽  
pp. 359-368
Author(s):  
Patricia J. Horvath
Keyword(s):  
United States ◽  
High School ◽  
High School Students ◽  
Mathematics Achievement ◽  
The United States ◽  
School Students ◽  
Twelfth Graders ◽  
The Pacific ◽  
Study Results ◽  
Second International

Japanese results from the Second International Mathematics Study (SIMS) for first-year middle school and third-year high school students appeared in Septemher 1981 under the title Chuugakkoo-Kookoo no Suugaku no Seiseki (Mathematics Achievement of Middle and High School Students). United States' results for SIMS for the eighth and twelfth graders appeared, respectively, in the April 1985 editions of the Arithmetic Teacher and Mathematics Teacher (McKnight and Travers 1985a, 1985b). More detailed results were available in a report entitled Second International Mathematics Study Summary Report for the United States of January 1985. Given the current state of thinking and interest on both sides of the Pacific in mathematics achievement, a look at some of the results for Japan in comparison with those of the United States is very timely.

Sign in / Sign up

Export Citation Format

Share Document