SBIR-STTR Award

The project introduces a new approach to standardizing disease-specific assessments of Health-Related Quality of Life (HRQOL) to achieve the advantages of both generic questionnaires, which can be compared across which have greater sensitivity and specificity. The approach builds on: (1) an item bank representing the most frequently measured domains of disease impact (e.g., role functioning, social functioning, and psychological distress), standardized across diseases, and (2) instructions to assess the impact of a specific disease (e.g., arthritis, diabetes) in answering each questionnaire item. The approach uses item response theory (IRT) and computerized adaptive testing (CAT) software to yield more practical and precise assessments over a wide range of disease conditions and severity levels - eliminating "ceiling" and "floor" effects. CAT software will be programmed to select and administer the most informative and relevant disease impact questions for each patient, with consideration of the clinical application. Standardization of the content of disease-specific impact items and calibration of these items across diseases makes it possible to achieve more responsive outcomes measures, while enabling meaningful comparisons across diseases/-treatments. Previous work has used IRT methodology to develop a bank of items with equivalent item calibrations across five diseases. The aims of Phase I of this project are to analyze existing data sets to evaluate the equivalence of these item calibrations across age groups and to test the feasibility of the Disease Impact CAT approach for elderly patients in a clinical setting. The feasibility study will use a prototype Disease Impact CAT to collect new data from 100 middle aged and elderly patients within five groups: arthritis, depression, chronic obstructive pulmonary disease, diabetes, and osteoporosis. Separate feedback reports will be developed for the patients and the clinicians. Feasibility will be evaluated in terms of respondent burden, range of levels measured, item usage, and response consistency, as well as the clinicians' and patients' experience using the prototype CAT tool and the feedback reports. The product of Phase I will be a prototype Disease Impact CAT with preliminary evidence regarding feasibility and acceptance. Phase II will develop and further evaluate the potential of a comprehensive Disease Impact CAT Assessment System, standardized across primary and comorbid chronic diseases/conditions, in terms of psychometric performance and usefulness in clinical research and practice.

Thesaurus Terms:
chronic disease /disorder, computer assisted medical decision making, computer system design /evaluation, data collection methodology /evaluation, health survey, human middle age (35-64), human old age (65+), quality of life age difference, chronic obstructive pulmonary disease, computer data analysis, depression, diabetes mellitus, mathematical model, osteoarthritis, osteoporosis, primary care physician behavioral /social science research tag, clinical research, human subject, psychometrics

This SBIR Phase II project will develop and evaluate a more practical and comprehensive approach to standardizing the self-assessment of disease-specific Health-Related Quality of Life (HRQOL) in the growing population of aging (45+ years) adults with, and at-risk of, co-morbid chronic conditions. Specifically, we propose to simplify disease impact screening (for prevention and early warning), and monitoring of HRQOL outcomes by adapting a consumer-focused Smart Measurement" system, developed using item response theory (IRT) to improve outcomes measures, utilizing computerized adaptive testing (CAT) software to improve data capture and score estimation, and deliver content via the Internet. Phase I demonstrated administrative feasibility and supported the assumptions underlying the standardization of the content of disease-specific impact items and their calibration across diseases to achieve measures that are more responsive to outcomes as well as meaningfully comparable across diseases. Other complimentary SBIR projects focusing on single diseases have demonstrated the potential for more practical and precise assessments over a wide range of severity levels - and the possibility of eliminating "ceiling" and "floor" effects. In Phase II we will combine these efforts and expand our tests of standardized disease-specific and generic measurement models among larger samples of aging adults with multiple co-morbid conditions by administering items from new standardized disease specific item banks as well as previously-validated disease-specific and generic HRQOL measures to address the following aims: (1) Improve the instrument and item pools using (a) qualitative methods and expert/consumer evaluation, (b) quantitative studies among large samples of the most prevalent and burdensome chronic conditions (e.g., asthma, CHF, CKD, depression, diabetes, headache, obesity, osteoarthritis), and (c) head-to-head comparisons between more efficient static and dynamic short forms versus "legacy" (previously-validated) tools; (2) Develop and evaluate aggregated disease-specific and generic feedback report(s), suitable for consumers (who are and are not currently "patients") and their clinicians, with user-friendly normative/benchmark interpretive information; (3) Evaluate the self-assessment system in a longitudinal prospective panel study to replicate tests of psychometric properties, test predictive validity (medical expenditures, role/social participation, mortality) and responsiveness, and address data quality, context and mode effects, accessibility of the Internet, and effects of respondent characteristics; (4) Gather norms by administering generic and disease specific measures to representative US population samples with and without chronic conditions. The Phase II product will be a fully operational self-assessment system for screening and monitoring disease impact for the aging population with multiple co-morbid conditions, including: improved "static" and dynamic (CAT) short forms for assessing disease impact and generic health outcomes, user-friendly feedback reports and documentation.

Public Health Relevance:
The Disease Impact Assessment Tool will measure the impact of multiple co-morbidities across the spectrum of physical functioning and mental well-being. It will simplify disease burden screening and provide more actionable information for use in early warning and health care stratification, and enable more practical monitoring of health outcomes for use by providers, payors, governments, researchers and most importantly, consumers that encourage self-management and patient-centered care delivery.

Public Health Relevance Statement:
7. Project Narrative The Disease Impact Assessment Tool will measure the impact of multiple co-morbidities across the spectrum of physical functioning and mental well-being. It will simplify disease burden screening and provide more actionable information for use in early warning and health care stratification, and enable more practical monitoring of health outcomes for use by providers, payors, governments, researchers and most importantly, consumers that encourage self-management and patient-centered care delivery. 1

Project Terms:
21+ years old; Address; Adult; Affect; Age; Age Group Unspecified; Aged 65 and Over; Aging; American; Area; Arthritis, Degenerative; Asthma; Benchmarking; Best Practice Analysis; Bronchial Asthma; CDC; Calibration; Care, Health; Caring; Centers for Disease Control; Centers for Disease Control (U.S.); Centers for Disease Control and Prevention; Centers for Disease Control and Prevention (U.S.); Cephalalgia; Cephalgia; Cephalodynia; Cephalodynias; Characteristics; Chronic; Chronic Disease; Chronic Illness; Clinical; Clinical Trials; Clinical Trials, Unspecified; Computer Programs; Computer software; Computers; Cranial Pain; Data; Data Collection; Data Quality; Degenerative polyarthritis; Development; Diabetes Mellitus; Disease; Disorder; Documentation; Drugs, Nonproprietary; Economic Burden; Elderly; Elderly, over 65; Emotional well being; Evaluation; Expenditure; Feedback; Feels well; Floor; Generic Drugs; Government; Head; Head Pain; Headache; Health; Health Care Costs; Health Care Research; Health Costs; Health Services Evaluation; Health Services Research; Health Status; Health Surveys; Health system; Healthcare; Healthcare Costs; Healthcare Research; Human, Adult; Individual; Internet; Investigators; Knowledge; Language; Level of Health; Life; Logic; Measurement; Measures; Medical; Medical Care Research; Mental well-being; Methods; Metric; Modeling; Monitor; Morbidity; Morbidity - disease rate; Mortality; Mortality Vital Statistics; Normal mental condition; Normal mental state; Normal psyche; Obesity; Osteoarthritis; Osteoarthrosis; Outcome; Outcome Measure; Outcome Study; Outcomes Assessments, Patient; PROV; Patient Outcomes Assessments; Patient Reported Outcomes; Patient-Centered Care; Patients; Performance; Phase; Physical Function; Population; Prevalence; Prevention; Property; Property, LOINC Axis 2; Provider; Psychological Well Being; Psychometric; Psychometrics; Public Health; QOL; Qualitative Methods; Quality of life; Questionnaires; Reporting; Research Personnel; Researchers; Respondent; Risk; Role; SBIR; SBIRS (R43/44); Sampling; Science; Screening procedure; Selection for Treatments; Self Assessment; Self Assessment (Psychology); Self Management; Senescence; Sense of well-being; Severities; Shipping; Ships; Small Business Innovation Research; Small Business Innovation Research Grant; Social Role-Participation; Software; Source; Standardization; Stratification; Survey Instrument; Surveys; System; System, LOINC Axis 4; Technical Expertise; Technology; Testing; Therapeutic; Time; Treatment outcome; United States Centers for Disease Control; United States Centers for Disease Control and Prevention; WWW; Well in self; adiposity; adult human (21+); advanced age; age group; aging population; base; burden of disease; burden of illness; chronic disease/disorder; chronic disorder; clinical investigation; clinical practice; computer program/software; computerized; corpulence; corpulency; corpulentia; degenerative joint disease; depression; diabetes; disease burden; disease/disorder; elders; generic; geriatric; health economics; health related quality of life; hypertrophic arthritis; improved; innovate; innovation; innovative; instrument; late life; later life; obese; obese people; obese person; obese population; older adult; older person; patient centered; patient oriented; population health; population survey; prospective; prototype; psychological wellness; public health medicine (field); public health relevance; response; screening; screenings; self wellness; senescent; senior citizen; services research; social; social role; technology development; theories; tool; user-friendly; web; world wide web; years of life lost to disability; years of life lost to disease