Development of a Computerized Adaptive Test for Patients with HIV Infection
Small Business Information
640 GEORGE WASHINGTON HIGHWAY, SUITE 201, LINCOLN, RI, 02865
AbstractDESCRIPTION (provided by applicant): With improvements in the survival of patients with HIV and AIDS, maximizing patients' functional status and well-being is increasingly an important treatment goal. Existing instruments for assessing HIV patients' self- reported functional status and well-being are fixed-form static questionnaires. They have limitations in range and precision that can restrict their usefulness in situations such as small-group studies and routine clinical practice. The overall goal of our project is to develop dynamic measures that combine computerized adaptive testing (CAT) technology and item response theory (IRT) to select the most relevant questions for each patient and provide brief, yet comprehensive and precise, assessments of patient-reported outcomes (PRO) in patients with HIV infection. We will develop an HIV-specific computerized adaptive test (the HIV-CAT) and its constituent item banks and test the performance of this new measurement system. The aims in Phase I of this project are: (1) to develop a prototype HIV-CAT that assesses PRO in seven health domains of relevance in HIV disease; (2) to test the feasibility and acceptability of administering the prototype HIV-CAT in clinical settings and through the Internet; and (3) to initialize construction of item banks for five additional domains specifically relevant to HIV disease. The prototype HIV-CAT will use existing item banks for physical functioning, bodily pain, general health perception, vitality, social functioning and mental health. An item bank for role functioning will be developed in Phase I using existing data. The five new item banks with particular relevance for HIV will cover the domains of cognitive function, body image, sleep, gastrointestinal symptoms and sexual function. We will evaluate the prototype HIV-CAT and pilot the four preliminary item banks using a sample of 100 HIV-infected patients in the Johns Hopkins Moore (HIV) Clinic and another 100 answering via the Internet. The feasibility and acceptability of assessments using the prototype HIV-CAT will be evaluated according to administration time; data completeness; patient-reported burden, relevance, and importance of the assessment; as well as IRT-based tests of response consistency. The five preliminary item banks will be evaluated using both qualitative and quantitative methods. In Phase II of this project, the prototype HIV-CAT and its constituent item banks will be further developed and refined using data collected from large samples of HIV-infected patients and the measurement properties of the HIV-CAT (such as precision, validity, and responsiveness) will be critically evaluated. The final tool will be useful in clinical research and practice, and will help providers better understand and monitor the impact of HIV and its treatment, thus improving quality of care for people living with HIV/AIDS. Question 7. Project Narrative The outcome of phase I of this SBIR will be a pilot HIV-CAT assessment system encompassing 12 health domains of relevance in HIV disease: physical functioning, bodily pain, general health perception, vitality, social functioning, role functioning, mental health, cognitive function, body image, sleep, gastrointestinal symptoms and sexual function The final tool will be useful in clinical research and practice, and will help providers better understand and monitor the impact of HIV and its treatment, thus improving quality of care for people living with HIV/AIDS.
* information listed above is at the time of submission.