Investigating the Impact of Mode of Administration on Item Response
Recruitment status was Not yet recruiting
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Purpose
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 |
|---|
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Chronic Obstructive Pulmonary Disease Depression Rheumatoid Arthritis |
| Study Type: | Observational |
| Study Design: | Time Perspective: Cross-Sectional |
| Official Title: | Investigating the Impact of Mode of Administration on Item Response |
- 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 ] [ Designated as safety issue: No ]
- Respondent preference and satisfaction with mode of administration [ Time Frame: One time assessment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 800 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | May 2009 |
| Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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IVR-PC
This group will have instruments administered through interactive voice response (IVR) and personal computer (PC).
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PP-PC
This group will have instruments administered through paper and pencil (PP) and PC.
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PDA-PC
This group will have instruments administered by personal digital assistant (PDA) and PC.
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PC-PC
This group will have all instruments administered through PC.
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Detailed Description:
This study is designed to systematically test the impact of mode of administration on patient-reported outcomes measures included in the PROMIS item banks. It is designed as a randomized cross-over study. Two non-overlapping alternate forms (Form A [FA] and Form B [FB]) with eight unique items each from three of the PROMIS domains (emotional distress-depression, fatigue, physical function) will be developed. Respondents will answer one of the forms by automated phone interview using interactive voice response (IVR) technology, paper and pencil questionnaire (PP), personal computer (PC), or personal digital assistant (PDA) technology. The other form will always be answered by PC. The order in which the forms are administered will be randomized. The two assessments will be separated by a short interval (e.g., 5 to 10 minutes), but will take place on the same day. The study is powered to evaluate equivalence within a score difference of +/-2.0 on a T-score metric (standard deviation of 10) with 85% power. Data for the IVR-PC, PP-PC, and PC-PC modes will be collected via Polimetrix (n=200 per arm, with random assignment to arm); data for the PDA-PC mode will be collected via Stony Brook (n=200). Respondents will have one or more of the chronic conditions studied in other Wave 2 studies (COPD, depression, or rheumatoid arthritis).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Community samples with at least one of these conditions: chronic obstructive pulmonary disease (COPD), depression (DEP), or rheumatoid arthritis (RA).
Inclusion Criteria:
- Diagnosis given by treating physician
Respondents required to take one or more of the following medications for their treatment:
- COPD: Inhalative steroids (e.g., budesonide, beclometasone), oral medication with theophylline (dimethylxanthine), 2 mimetic (e.g., formoterol, salmeterol), leukotriene antagonists (e.g., montelukast), or oral corticosteroids (e.g., prednisolone)
- DEP: Anti-depressive drugs (e.g., mirtazapine, escitalopram) and/or received a recognized psychotherapeutic treatment for depression within the last year
- RA: Anti-inflammatory medications (e.g., Cox-2 inhibitors, acetylsalicylic acid of more than 500mg/d, diclofenac, ibuprofen), immunosuppressants (e.g., methotrexate, leflunomide), immune modulators (e.g., infliximab, etanercept), or steroids (e.g., prednisolone) for current treatment of RA
- Fluent in English
- Have Internet access and an e-mail address (for the IVR-PC, PP-PC and PC-PC arms)
- Willing and able to give informed consent
Contacts and Locations| Contact: Barbara L. Gandek, MS | bgandek@qualitymetric.com |
| United States, California | |
| Polimetrix | Not yet recruiting |
| Palo Alto, California, United States, 94301 | |
| Contact: Barbara L. Gandek, MS 781-419-6564 bgandek@qualitymetric.com | |
| United States, New York | |
| Rheumatology Associates of Long Island | Not yet recruiting |
| Smithtown, New York, United States, 11787 | |
| Contact: Arthur Stone, PhD 631-632-8833 arthur.stone@sunysb.edu | |
| Principal Investigator: | John E. Ware, PhD | QualityMetrics |
| Principal Investigator: | Arthur Stone, PhD | Stony Brook University |
More Information
No publications provided
| Responsible Party: | John E. Ware, QualityMetrics |
| ClinicalTrials.gov Identifier: | NCT00783991 History of Changes |
| Other Study ID Numbers: | 07-05 |
| Study First Received: | October 30, 2008 |
| Last Updated: | April 7, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
|
IVF PDA PC CAT |
COPD MDD RA |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Depression Depressive Disorder Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Joint Diseases |
Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Behavioral Symptoms Mood Disorders Mental Disorders Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013