Rho Supports Manuscript Establishing Key Metrics For The Composite Asthma Severity Index
CRO serves as the Statistical and Clinical Coordinating Center for NIH-sponsored study
Chapel Hill, NC ? March 7, 2017 ? Rho, a full-service contract research organization (CRO) focused on bringing new products to market through a full range of product development services, co-authored a newly published letter to the editor of the Journal of Allergy and Clinical Immunology (JACI) expanding on the Composite Asthma Severity Index (CASI). Introduced in JACI in March 2012, CASI is a quantitative measure of asthma severity that incorporates 5 domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures and exacerbations. The CASI score ranges from zero to 20 points, with higher values indicating higher levels of severity. The letter builds on an earlier publication, comparing the CASI to an expert clinician assessment of asthma severity.
The report used statistical methodology and simulations to establish key metrics for the CASI, including risk levels, the minimally important difference (MID) and the minimally important effect size. Data were sourced from the Asthma Phenotypes in the Inner City Study, which enrolled children and adolescents with a wide range of asthma severities.
“Asthma severity is multidimensional in nature, which makes asthma a complicated condition for doctors and patients to manage,” said Rebecca Krouse, Senior Biostatistician, Rho. “The CASI score is intended to help merge asthma treatment, current symptoms and future risk into a single measure. This provides a comprehensive assessment of asthma severity that can serve as a research tool for intervention studies.”
Information and resources related to CASI, including publications, sample study forms and an online calculator, are publicly available at www.asthmaseverity.org.
As part of Rho’s federal market work, the company serves as the Statistical and Clinical Coordinating Center for the Inner-City Asthma Consortium, a nationwide clinical network supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. In this role, Rho supports 10 clinical research sites and three basic science sites in studies evaluating the efficacy of therapeutic agents for the treatment of asthma in inner-city children with the intent to better understand the underlying causes of the disease. Rho provides support for statistical analysis, safety monitoring, data management and clinical monitoring and also supports study protocol and manuscript development.
This work was funded in part by NIAID under award numbers HHSN272200900052C and HHSN272201000052I. GSK provided asthma and rhinitis medications. Additional details about the Asthma Phenotypes in the Inner City study are available at ClinicalTrials.gov using the identifier NCT01383941.
To learn more about Rho, please visit www.rhoworld.com.
About Rho
Rho, a privately-held, full-service contract research organization (CRO) located in Chapel Hill, NC, provides a full range of clinical research services across the entire drug development process. For more than 32 years, Rho has been a trusted partner to some of the industry’s leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. Our commitment to excellence, our innovative technologies, and our therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience. Please follow us on Twitter.
Chapel Hill, NC ? March 7, 2017 ? Rho, a full-service contract research organization (CRO) focused on bringing new products to market through a full range of product development services, co-authored a newly published letter to the editor of the Journal of Allergy and Clinical Immunology (JACI) expanding on the Composite Asthma Severity Index (CASI). Introduced in JACI in March 2012, CASI is a quantitative measure of asthma severity that incorporates 5 domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures and exacerbations. The CASI score ranges from zero to 20 points, with higher values indicating higher levels of severity. The letter builds on an earlier publication, comparing the CASI to an expert clinician assessment of asthma severity.
The report used statistical methodology and simulations to establish key metrics for the CASI, including risk levels, the minimally important difference (MID) and the minimally important effect size. Data were sourced from the Asthma Phenotypes in the Inner City Study, which enrolled children and adolescents with a wide range of asthma severities.
“Asthma severity is multidimensional in nature, which makes asthma a complicated condition for doctors and patients to manage,” said Rebecca Krouse, Senior Biostatistician, Rho. “The CASI score is intended to help merge asthma treatment, current symptoms and future risk into a single measure. This provides a comprehensive assessment of asthma severity that can serve as a research tool for intervention studies.”
Information and resources related to CASI, including publications, sample study forms and an online calculator, are publicly available at www.asthmaseverity.org.
As part of Rho’s federal market work, the company serves as the Statistical and Clinical Coordinating Center for the Inner-City Asthma Consortium, a nationwide clinical network supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. In this role, Rho supports 10 clinical research sites and three basic science sites in studies evaluating the efficacy of therapeutic agents for the treatment of asthma in inner-city children with the intent to better understand the underlying causes of the disease. Rho provides support for statistical analysis, safety monitoring, data management and clinical monitoring and also supports study protocol and manuscript development.
This work was funded in part by NIAID under award numbers HHSN272200900052C and HHSN272201000052I. GSK provided asthma and rhinitis medications. Additional details about the Asthma Phenotypes in the Inner City study are available at ClinicalTrials.gov using the identifier NCT01383941.
To learn more about Rho, please visit www.rhoworld.com.
About Rho
Rho, a privately-held, full-service contract research organization (CRO) located in Chapel Hill, NC, provides a full range of clinical research services across the entire drug development process. For more than 32 years, Rho has been a trusted partner to some of the industry’s leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. Our commitment to excellence, our innovative technologies, and our therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience. Please follow us on Twitter.