Investigating the Impact of Mode of Administration on Item Response
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Chronic Obstructive Pulmonary Disease, Depression, Rheumatoid Arthritis, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/27/2013 |
| Start Date: | April 2009 |
| End Date: | May 2009 |
| Contact: | Barbara L. Gandek, MS |
| Email: | bgandek@qualitymetric.com |
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.
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).
Inclusion Criteria:
- Diagnosis given by treating physician
- Respondents required to take one or more of the following medications for their
treatment:
1. 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)
2. DEP: Anti-depressive drugs (e.g., mirtazapine, escitalopram) and/or received a
recognized psychotherapeutic treatment for depression within the last year
3. 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
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