Investigating the Impact of Mode of Administration on Item Response
|ClinicalTrials.gov Identifier: NCT00783991|
Recruitment Status : Completed
First Posted : November 3, 2008
Last Update Posted : June 6, 2013
The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap initiative to develop a computerized system measuring patient-reported outcomes in respondents with a wide range of chronic diseases and demographic characteristics. In the first four years of its existence, the PROMIS network developed item banks for measuring patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical function, and social functioning. During the item banking process, the PROMIS network conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses to refine the meaning, clarity, and literacy demands of all items. The item banks were administered to over 20,000 respondents and calibrated using models based on item response theory (IRT). Using these IRT calibrations, computerized adaptive test (CAT) algorithms were developed and implemented. The network has designed a series of studies using clinical populations to evaluate the item attributes, examine their utility as CATs, and validate the item banks. More information on the PROMIS network can be found at www.nihpromis.org.
This study is designed to examine how differences in modes of data capture affect psychometric properties and score differences and to evaluate the consistency of these results across three PROMIS health domains: emotional distress-depression, fatigue, and physical function. Four modes of administration will be compared: interactive voice response (IVR) technology, paper and pencil questionnaire, personal computer, and personal digital assistant (PDA). A total of 800 patients will be enrolled from three diagnostic groups: chronic obstructive pulmonary disease (COPD), depression, and rheumatoid arthritis. The study will test for equivalence across modes of administration, with the hypothesis that there are no mode effects; if mode effects are found, their magnitude across modes will be estimated. This network project will result in an improved understanding of the effect of assessment mode on patient-reported outcome (PRO) data. Guidance from this project can help in planning future PROMIS activities beyond the present PROMIS program.
|Condition or disease|
|Chronic Obstructive Pulmonary Disease Depression Rheumatoid Arthritis|
|Study Type :||Observational|
|Actual Enrollment :||800 participants|
|Official Title:||Investigating the Impact of Mode of Administration on Item Response|
|Study Start Date :||April 2009|
|Primary Completion Date :||December 2009|
|Study Completion Date :||December 2009|
This group will have instruments administered through interactive voice response (IVR) and personal computer (PC).
This group will have instruments administered through paper and pencil (PP) and PC.
This group will have instruments administered by personal digital assistant (PDA) and PC.
This group will have all instruments administered through PC.
- IRT-derived scores from two parallel static short forms containing eight items each from three PROMIS domains (emotional distress-depression, fatigue, physical function) [ Time Frame: One time assessment ]
- Respondent preference and satisfaction with mode of administration [ Time Frame: One time assessment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00783991
|United States, California|
|Palo Alto, California, United States, 94301|
|United States, New York|
|Rheumatology Associates of Long Island|
|Smithtown, New York, United States, 11787|
|Principal Investigator:||John E. Ware, PhD||QualityMetrics|
|Principal Investigator:||Arthur Stone, PhD||Stony Brook University|