2013 — 2014 |
Butt, Zeeshan Ahmad |
R03Activity Code Description: To provide research support specifically limited in time and amount for studies in categorical program areas. Small grants provide flexibility for initiating studies which are generally for preliminary short-term projects and are non-renewable. |
Improving Longitudinal Quality of Life Assessment in Hepatocellular Carcinoma @ Northwestern University At Chicago
DESCRIPTION (provided by applicant): Hepatocellular carcinoma (HCC) is a primary hepatic malignancy that affects individuals with chronic liver disease. The incidence of HCC has been increasing in recent years; it is currently the third leading cause of cancer death worldwide and the ninth leading cause of cancer death in the United States. Although there are a variety of treatment options available for patients with HCC, no comprehensive treatment model exists. Quality of life (QOL) outcomes are frequently omitted in HCC research but would provide useful information for the creation of any treatment decision model. Specifically, there is a need for additional data on the longitudinal course of QOL among patients with HCC, particularly those undergoing therapy. To that end, the overarching goals of this pilot study are: (1) to develop, test, and assess a web-based, tablet PC data collection application that will allow seamless integration of QOL data with the electronic health record, and (2) to conduct a longitudinal study of health-related QOL in a cohort of patients with newly diagnosed HCC. Such data will provide needed preliminary data to inform larger observational or intervention trials and will provide initial estimates of the impact of cancer stage, progression, performance status, underlying liver disease, and demographic variables on relevant QOL domains. Our goal is to use these pilot data, which would be one of the largest datasets of longitudinal HCC QOL to date, to inform a multi-center study, with an eye toward development of a data-driven treatment decision model.
|
0.952 |
2019 |
Butt, Zeeshan Ahmad |
U01Activity Code Description: To support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies. |
Development of a Context of Use and Promis Physical Function Outcome Assessment For Patients With Sarcopenia @ Northwestern University At Chicago
Sarcopenia is the age-related decline in skeletal muscle mass concomitant with decreased strength and/or function. All hospitalization, sarcopenia malignancies, conditions related to reduced muscle activity predispose to sarcopenia (e.g., sedentary lifestyle, immobilization, prolonged bed rest). Certain diseases can also promote the development of through chronic inflammation and metabolic derangements, such as endocrine disorders, chronic inflammatory diseases, and advanced organ failure (heart, lung, liver, kidney or brain). Sarcopenia has been linked to falls, physical frailty and disability. A valid measure of physical function, such as the PROMIS physical function item bank, can help evaluate whether new therapies for sarcopenia can produce an overall benefit to the patient. Our primary aims for the current proposal are to respond to the FDA request to our approved COA Letter of Intent (DDT #085), to (1) develop an appropriate context of use and (2) develop a fit-for-purpose measure of physical function for patients with sarcopenia. In November, 2015, our team of researchers at Northwestern University received a request from the Division of Endocrine/Metabolism at the US Food and Drug Administration (FDA). Highlighting an unmet need for well-defined and reliable outcome assessment of physical function in sarcopenia, the FDA asked us to submit the PROMIS measure of Physical Function as a clinical outcome assessment (COA) under their Drug Development Tools (DDT) qualification program. Based on feedback we received form the FDA on our initial Letter of Intent, our work on this initiative will begin by identifying one or more specific contexts of use (COUs) in which the assessment of physical function serves as the primary metric for labeling claims related to sarcopenia. Insights from our expert consultants will greatly influence these decisions. We will also solicit patient and other expert feedback to develop a targeted PROMIS Short Form of Physical Function for use in patients with sarcopenia. This work will put us closer to developing a qualification plan for submission to the FDA that will detail the development of the Physical Function item bank and present relevant PROMIS Physical Function data to support the validity of the bank (or short forms derived from the bank) for patient reported clinical trial outcomes. At the end of the year of funding, we anticipate having a targeted PROMIS Physical Function short form that can be further tested and used within clinical trials to benefit patients with sarcopenia.
|
0.952 |
2019 — 2021 |
Butt, Zeeshan Ahmad |
P30Activity Code Description: To support shared resources and facilities for categorical research by a number of investigators from different disciplines who provide a multidisciplinary approach to a joint research effort or from the same discipline who focus on a common research problem. The core grant is integrated with the center's component projects or program projects, though funded independently from them. This support, by providing more accessible resources, is expected to assure a greater productivity than from the separate projects and program projects. |
Outcomes Measurement and Survey Core Facility Shared Resource @ Northwestern University At Chicago
ABSTRACT ? OUTCOMES MEASUREMENT AND SURVEY CORE The goal of the Outcomes Measurement and Survey Core (OMSC) is to provide consultation and support for projects that involve collecting, analyzing and interpreting self-report data, and to promote the understanding of measurement fundamentals and the improvement of survey research practice. By offering our expertise gained from years of experience with research on self-report data and community-based participatory research, this shared resource provides vital support services for clinical trials, observational studies and health services research projects. OMSC personnel have expertise in survey research methodology, Patient-Reported Outcomes (PRO) measurement, qualitative research methods, psychometrics, as well as study recruitment and retention for adults and children with diverse language, literacy, cognitive, functional and computer skills. The aims of the core are: 1) to provide consultative and practical expertise on self-report measurement, analysis, and interpretation in culturally diverse populations across the lifespan; 2) to serve as a central resource for state- of-the-science PRO instruments and survey methods; and 3) to provide assistance with recruitment of community participants for research studies. To accomplish these aims, OMSC members work closely with Lurie Cancer Center (LCC) investigators and interact with several other complementary Shared Resource Facilities, particularly the Quantitative Data Science Core. During the current usage reporting period, the OMSC worked with 43 different LCC members on 52 projects, across six different LCC research programs. Over the next funding period, the OMSC will continue to provide the Lurie Cancer Center with psychometric and survey research support in the areas of study design, data collection, analysis and interpretation, and will add support for recruitment and retention of community participants in cancer-relevant research.
|
0.952 |