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Validity Studies Testing
Incorporating feedback and recommendations from the PROMIS NIH science officers as well as the Scientific Advisory Board regarding direction of the next wave (Validity Studies) of PROMIS network research activity, the SC decided to focus on validation of existing banks for the five domains versus development of new banks. The SC established a strategy for deciding on Validity Studies activity, which included defining study design and validation criteria for Validity Studies network protocols, defining clinical populations for study, and initiating draft protocols in:
* Depression and low back pain with a community sample comparison
* Arthritis
* Congestive heart failure (CHF)
* Chronic obstructive pulmonary disease (COPD)
* Mode of administration
* Cancer PROMIS Supplement
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PAIN AND DEPRESSION PROTOCOL
Title: Validating PROMIS Instruments in Depression and Back and Leg Pain
Study Type: Observational
Sponsor: National Institutes of Health
Collaborators: Paul A. Pilkonis, University of Pittsburgh, PI; Dagmar Amtmann, University of Washington, PI; Judith Turner, University of Washington; Janna Friedly, University of Washington; Jordan Karp, University of Pittsburgh; Jennifer Beaumont, NorthShore University HealthSystem; Karon Cook, University of Washington; Lan Yu, University of Pittsburgh; Angela Stover, University of Pittsburgh; Rana Salem, University of Washington
Brief Summary: This protocol is aimed at comparing the psychometric properties of the PROMIS item banks with non-PROMIS “gold standard” instruments currently used in our respective fields (pain and mental health). In this context, note that the proposed study is not intended to evaluate treatment effectiveness, and no control group has been included. The main consideration has been to design a study involving ecologically valid treatments with established efficacy that can be administered and evaluated over the short term (i.e., 3 months). Regardless of their impact in the aggregate, such treatments will generate considerable variability in individual outcomes, and this heterogeneity is optimal for examining relevant psychometric issues. The psychometric issue of greatest concern is the validity of the PROMIS item banks as evidenced in convergent and discriminant validity and responsiveness to change. We also will make initial estimates of clinically significant change as reflected in our PROMIS measures. By combining efforts of the two sites that led in the development of the item banks for emotional distress (University of Pittsburgh) and pain (University of Washington), the study will maximize total sample size and provide a fertile ground for analyses of psychometric functioning of the PROMIS banks.
In addition to psychometric questions, we will also address clinically meaningful questions related to pain, depression, and the relationship between the two. The complex relationship between pain and depression has been observed for years. Both syndromes are mutually exacerbating—pain worsens depression and depression worsens the experience of pain. The domain-related issues of greatest interest focus on the interaction between depression and pain and its impact on treatment outcome (including changes in symptoms of both depression and pain, in acute clinical status, and in social functioning).
Start Date: Depression: June, 2008; Pain: July, 2008
Complete Date: Depression: July, 2009; Pain: July, 2009
Study Design: Case Only
Time Perspective: Prospective
Enrollment Target: Depression, N=115; Pain, N=185
# of Groups/Cohorts: 1 for each
Outcome Measures: Primary outcome measures: Instruments will include PROMIS computerized adaptive tests (CATs) for pain, fatigue, social functioning, depression, anxiety, anger, sleep, wake, and physical functioning, and non-PROMIS measures (conventional instruments) also administered by computer. Secondary outcome measures: We also will make judgments of clinically significant change (via diagnostic interviews) and compare these with the changes reflected in our PROMIS measures.
Time frame: Assessments at baseline, 1 month, and 3-month follow-up
Group/Cohort Label: Depression: Depressed adults in open treatment; Pain: Patients with back and leg pain (sciatica) scheduled for and received an epidural steroid injection
Group/Cohort: Depression: Meets DSM-IV criteria for Major Depressive Disorder; Pain: Patients with back and leg pain (sciatica) scheduled for and received an epidural steroid injection
Intervention Type: Depression: this is an observational study in which outpatients receive uncontrolled active treatment including drug, behavioral intervention, or both; Pain: This is an observational study in which outpatients receive procedural intervention(s).
Study Population: Depression: Adults who have started treatment for an episode of Major Depressive Disorder in the last 4 months at Western Psychiatric Institute and Clinic in Pittsburgh, PA.; Pain: Patients with back and leg pain scheduled for epidural steroid injections that have had pain for at least 6 weeks.
Sampling Method: Non-probability sample for both depression and pain
Eligibility Criteria: Depression: Inclusion: Males and female; Age 18 or older ; Willing and able to give informed consent; English-speaking, able to read and understand English; Currently in the first 4 months of outpatient treatment at Western Psychiatric Institute and Clinic (WPIC) for major depressive disorder (MDD); Participants will be required to have a minimum score of 12 on the 17-item Hamilton Rating Scale for Depression; Exclusion: Lack of willingness or ability to provide informed consent; Dementia or other cognitive impairment that would interfere with questionnaire completion; Lifetime history of any psychotic disorder (e.g., schizophrenia, schizoaffective disorder) or bipolar disorder as evidenced in the participant’s medical records or reported during the SCID interview; Organic affective syndrome (i.e., mood disorder secondary to a general medical condition or substance-induced mood disorder; Current psychiatric inpatient treatment; A history of continuous care for one year or more in the mental health care system within the prior five years (in order to eliminate patients with more chronic presentations); Major medical conditions that influence the central nervous system (e.g., Parkinson’s disease, stroke, amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), systemic lupus erythematosus (SLE), seizure disorders, etc.) Note: Persons with common psychiatric comorbidities (e.g., anxiety disorders) will be included. The presence of psychiatric comorbidities will be documented.
Pain: Inclusion: 18+ years old; Have back pain with sciatica for at least 6 weeks; Scheduled for an epidural steroid injection (and did not receive ESI in past 3 months). Exclusion: NOT scheduled for ESI; Has dementia or other cognitive impairments that would interfere with questionnaire completion; Received an ESI within the last 3 months; History of prior lumbar surgery in the last year, unstable neurological symptoms (i.e. experiencing bowel or bladder incontinence, numbness in groin area, new or worsening weakness in legs or new numbness or tingling in legs), cauda equina syndrome, cancer, spinal cord injury, vertebral fractures or MS
Gender: Both
Age: 18 years and older
Facility: Depression: University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic, 3811 O’Hara St., Pittsburgh, PA 15213, USA; Pain: Harborview Medical Center: UW Medicine Spine Clinic. Seattle, WA 98104, USA and University of Washington Medical Center: UW Sports and Spine Physicians, Seattle, WA 98105, USA
Investigators: Depression: Paul A. Pilkonis, PhD, Principal Investigator; Co-I: Jordan Karp, MD ; Co-I: Lan Yu, PhD; Pain: Dagmar Amtmann, PhD, Principal Investigator
General Contact: Depression: Angela Stover, M.A, Program Coordinator, Pittsburgh PROMIS, 412-246-5551, stoveram@upmc.edu; Pain: Alyssa Bamer M.A., Research Scientist and Manager, adigiaco@u.washington.edu
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COPD PROTOCOL
Title: Validation of PROMIS Banks with COPD Exacerbations
Study Type: Observational
Sponsor: National Institutes of Health
Collaborators: University of North Carolina at Chapel Hill, University of Pittsburgh, Duke University, NorthShore University Health System
Brief Summary: This is a prospective, longitudinal study of adult patients with Chronic Obstructive Pulmonary Disease (COPD), patients who will be enrolled when their COPD is considered clinically stable or during an acute exacerbation. This design will allow both within-person and between person comparisons by exacerbation experience. Comprehensive clinical and patient-reported assessments will be performed at baseline and at 3 months (end of study). Subsets of items will be administered by interactive voice response (IVR) over the course of the study to measure changes in key symptoms over the course of recovery from an exacerbation. A subset of patients will be interviewed at the end of the study to assess content validity of PROMIS items in this patient population.
With such a study design, we will be able to evaluate the validity of the PROMIS items in this patient population under acute and stable conditions and evaluate responsiveness of several PROMIS item banks under conditions of known change in an underlying chronic disease. We will also evaluate stability of sub-domains that are not hypothesized to change with COPD exacerbations.
Start Date: July 1, 2008
Complete Date: June 30, 2009
Study Design: Cohort
Time Perspective: Prospective
Enrollment Target: N=180
# Groups/Cohorts: 2
Outcome Measures: Primary Outcome Measures: Changes in scores on PROMIS measures: Change in scores on PROMIS measures from baseline to 3 months. Comparing patients starting in stable state to patients having an exacerbation.
Group/Cohort Label: Stable, Exacerbation
Group/Cohort: Stable: Patients who are stable have not had a COPD exacerbation in the past 2 months; Exacerbation: Patients with an exacerbation have been diagnosed and started on treatment for an exacerbation within the past 3 days.
Intervention Type: None
Study Population: People presenting to primary care or specialty clinics with COPD either with exacerbation or not. People admitted to the hospital with a COPD exacerbation.
Sampling Method: Non-probability sample
Eligibility Criteria: Inclusion: Gender: Male or Female (we will attempt to enroll approximately 50% men/women); Age: >= 40 years; Diagnosis: An established clinical history of COPD in accordance with the GOLD definition (chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease with some significant extrapulmonary effects that may contribute to the severity in individual patients. Its pulmonary component is characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and associated with an abnormal inflammatory response of the lung to noxious particles or gases.); A history of smoking (at least 10 pack/year history); Access to and able to communicate on a touch tone telephone; Read and speak English; Able to see and interact with a computer screen, mouse and keyboard; Informed Consent: A signed and dated written informed consent prior to study participation; For those enrolled into the exacerbation group, patients must have been diagnosed with an exacerbation within 3 days of the day of enrollment; For those enrolled in the stable state group, the patient will be considered stable if he or she has been exacerbation-free for a minimum of 2 months prior to enrollment.
Exclusion: A subject will not be eligible for inclusion in this study if in the investigator’s opinion the patient has any concurrent medical or psychiatric condition that may preclude participation in this study or completion of self-administered questionnaires (e.g., moderate to severe dementia and/or severe, uncontrolled schizophrenia, or other condition that would render them unable to complete a questionnaire); History of asthma without co-existent COPD as the primary diagnosis; Patients experiencing a current heart failure exacerbation. A diagnosis of heart failure is not in itself an exclusion criterion.
Gender: Both
Age: 40 years or older
Facility: University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; University of Pittsburgh and the Pittsburgh VA, Pittsburgh, PA, USA; NorthShore University HealthSystem, Evanston, IL, USA
Investigators: UNC: Darren DeWalt, MD, MPH, Site Principal Investigator; Debra Irwin, PhD, Co-Investigator; James Donohue, MD, Co-Investigator; Pittsburgh: Charles Atwood, MD, Site Principal Investigator; Duke: Neil MacIntyre, MD, Site Principal Investigator; NorthShore University HealthSystem: Susan Yount, PhD, Site Principal Investigator
General Contact: Kelli Scanlon: 919-843-6604; kscanlon@email.unc.edu
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CHF PROTOCOL
Title: Validating PROMIS Instruments in Congestive Heart Failure Patients Receiving A Heart Transplant
Study Type: Observational
Sponsor: National Institutes of Health
Collaborators: Duke University Medical Center, Stanford University and the University of Pittsburgh
Brief Summary: This project will assess the validity (including responsiveness) of selected Patient Reported Outcome Measurement Information System (PROMIS) instruments in patients with severe chronic heart failure (CHF) who receive heart transplants. The following is a list of goals for this project:
* To estimate the responsiveness of PROMIS domain scores by comparing scores in patients with severe heart failure before and after a clinically significant event (heart transplant). The specific PROMIS domains assessed are physical functioning, fatigue, satisfaction with discretionary social activities, depression, and global health.
* To estimate the responsiveness of a disease-specific PRO measure, the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the Medical Outcomes Study Short Form-36 Vitality subscale (SF-36v2) and the Patient Health Questionnaire (PHQ-2).
* To collect cross-sectional and longitudinal data on traditional clinical measures of heart failure outcome (6 minute walk test and NYHA class) that can inform the definition of a minimally important difference (MID) for the PROMIS domains of physical functioning, fatigue, satisfaction with discretionary social activities, depression, and global health.
Start Date: December, 2008
Complete Date: 2009
Study Design: Cohort
Time Perspective: Prospective
Enrollment Target: N=150
# Groups/Cohorts: 1
Label: Heart transplant recipients
Group/Cohort: To be eligible, heart failure had to represent the greatest medical limitation on daily function for the patient in the judgment of the attending cardiologist.
Intervention Type: Other; this is an observational study only. No treatment will be assigned to these patients through this protocol. The intervention decision (heart transplant surgery) will be made solely by patients and their physicians and reported to us. Usual clinical care for patients win this study will not be altered.
Study Population: Participants will be recruited through heart transplant program registries and in consultation with practicing cardiologists at Duke University, Stanford University and the University of Pittsburgh.
Sampling Method: Probability Sample
Eligibility Criteria: Inclusion: To be eligible, heart failure had to represent the greatest medical limitation on daily function for the patient in the judgment of the attending cardiologist; Must be 18 years old or older; Ability to read, write, and speak in English; Ability to understand and provide informed consent; No current diagnosis of psychosis or dementia; Placement on heart transplant registry (awaiting heart transplant surgery)
Gender: Both
Age: 18 years and older
Facility: Duke University Medical Center, Durham, NC, USA; Stanford University, Palo Alto, CA, USA; University of Pittsburgh Medical Center, Pittsburgh, PA, USA
Investigator: Kevin P. Weinfurt, Ph.D; Site Principal Investigator
Contact: Felicia L. Graham, MBA; 919-668-8670; Felicia.graham@duke.edu
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ARTHRITIS PROTOCOL
Title: Initial Validation Of PROMIS Physical Function/Disability Scales In Rheumatoid Arthritis (RA)
Study Type: Observational
Sponsor: National Institutes of Health
Collaborators: Stanford University, QualityMetric Inc.
Brief Summary: Conduct initial validation studies of the PROMIS physical function, fatigue, and Pain Interference short forms in patients with rheumatoid arthritis (RA).
Start Date: June, 2008
Complete Date: July, 2009
Study Design: Observational Study Model
Cohort: Randomized to questionnaire order
Time Perspective: Prospective
Enrollment Target: N=525
# of Groups/Cohorts: 1
Outcome Measure: Primary outcome: ability of Legacy or PROMIS instruments to detect change over 6 and 12 months in rheumatoid arthritis: (a) when an antiTNFdrug has been begun, (b) when the patients reports improvement over the prior period, (c) when the patient global has improved over the prior period.
Group/Cohort Label: Legacy HAQ-DI first, PROMIS 20item short form first
Group/Cohort: Rheumatoid arthritis patients, before and after comparisons of physical function using Legacy HAQDI and PROMIS 20item short forms; all in cohort receive both questionnaires at the same administration, with the randomized to eliminate order effects
Intervention Type: Comparative questionnaire study for sensitivity to change of alternative questions
Study Population: Patients from 3 sources will be included in the study: ARAMIS RA cohort, Stanford RA registry, and Stanford RA clinical trials patients
Sampling Method: Probability Sample
Eligibility Criteria: rheumatologist diagnosed RA; meets one of the conditions for treatment intensification as described in the protocol; ability to read, write, speak English, ability to understand and provide informed consent
Gender: Both
Age: 18 years and older
Facility: Stanford University School of Medicine, 1000 Welch Rd. Suite 203, Palo Alto, CA 94304 USA, 6507254612
Investigator: James F. Fries, MD, Site Principal Investigator
Facility Contact: Karen Fisher, Research Process Manager, Kfisher@stanford.edu
General Contact: Deborah Ambrosini, dka@stanford.edu
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MODE OF ADMINISTRATION PROTOCOL
Title: Investigating the Impact of Mode of Administration on Item Response
Study Type: Observational
Sponsor: National Institutes of Health
Collaborators: QualityMetric Incorporated, Stony Brook University, NorthShore University HealthSystem, Stanford University
Brief Summary: 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, 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 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 crossover study. Two nonoverlapping 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., 510 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 Tscore metric (standard deviation of 10) with 85% power. Data for the IVRPC, PPPC and PCPC modes will be collected via Polimetrix (n=200 per arm, with random assignment to arm); data for the PDAPC mode will be collected via Stony Brook (n=200). Respondents will have one or more of the chronic conditions studied in other Validity Studies (COPD, depression, or rheumatoid arthritis)
Start Date: November, 2008
Complete Date: July, 2009
Study Design: Other. This is a randomized intervention study using a cross-over design. The “intervention” is the different modes of data collection.
Time Perspective: Cross-sectional
Enrollment Target: N=800
# Groups/Cohorts: 200 people in each of 4 groups: (IVR-PC, paper/pencil-PC, PDA-PC, PC-PC)
Label: IVR-PC, PP-PC, PC-PC, and PDA-PC
Outcome Measures: IRT derived scores from two parallel static short forms containing eight items each from three PROMIS domains (emotional distress-depression, fatigue, physical function)
Primary Outcome Measure: Emotional distress-depression, fatigue, and physical function; Secondary Outcome Measure: Respondent preference and satisfaction
Time Frame: One time assessment
Group/Cohort: The study groups differ in terms of modes of data capture.
Intervention Type: Other: The intervention is mode of survey administration.
Study Population: Community samples with at least one of these conditions: chronic obstructive pulmonary disease (COPD), depression (DEP), or rheumatoid arthritis (RA).
Sampling Method: Non-Probability Sample
Eligibility Criteria: Inclusion: 1. Diagnosis given by treating physician; 2. Respondents required to take one or more of the following medications for their treatment. COPD: Inhalative steroids, oral medication with theophylline, 2 mimetica, leukotrien antagonists or oral corticosteroids; DEP: Anti-depressive drugs and/or received a recognized psychotherapeutic treatment for depression within the last year; RA: Anti-inflammatory medications, immunosuppressants, immune modulators, or steroids for current treatment of RA; 3. Age 18 or older; 4. Fluent in English; 5. Internet access and an e-mail address (for the IVR-PC, PP-PC and PC-PC arms)
Gender: Both
Age: 18 years and older
Facility: IVRPC, PPPC, PCPC arms: Internet data collection through Polimetrix, Palo Alto, CA, USA; PDAPC arm: Rheumatology Associates of Long Island, NY, USA
Investigator: John E. Ware, Jr., Ph.D., Principal Investigator; Arthur Stone, Ph.D., Co-Principal Investigator
Central Contact: Barbara L. Gandek, MS, bgandek@qualitymetric.com
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CANCER PROMIS SUPPLEMENT
Title: Identifying Minimally Important Difference Scores in PROMIS-Cancer Measures: A Cancer PROMIS Supplement (CaPS) Initiative
Study Type: Observational
Sponsor: National Cancer Institute
Collaborators: Center on Outcomes, Research & Education (CORE)
Brief Summary: This is a prospective, longitudinal study of adult patients with cancer who are enrolled when beginning a new cancer treatment. The primary study aim is to identify minimally important difference (MID) scores for the following PROMIS-Cancer (PROMIS-CA) item banks developed by CaPS: Pain Interference, Fatigue, Physical Function, Anxiety and Depression. Converging anchor- and distribution-based methods, we will identify MIDs for item response theory (IRT) scores derived from static, fixed-length forms as well as computer adaptive test (CAT)-derived scale scores. These MIDs will be compared to classical “raw score” MIDs in a sensitivity analysis so that conversions from one to the other can be made by end-users. This will be done in two sub-studies: the first (N=80) uses only PROMIS-CA static short-forms and includes extensive collection of clinical activity data via physician query and chart extraction; the second (N=200) uses PROMIS-CA CATs and static short-forms and more limited collection of clinical activity data. Both sub-studies include the same clinically-relevant anchor measures.
At baseline, participants complete PROMIS-CA CATs and/or short forms, PROMIS global items, and domain-specific clinically relevant anchors (e.g., Hospital Anxiety & Depression Scale; Brief Pain Inventory). At follow-up (6-12 weeks later), participants repeat the CATs and/or short forms, global items, and clinical anchors, and complete global ratings of change scores. Medical information (e.g., treatment changes; disease status) is collected at both time points, with updates noted.
Distribution based analyses will use standard deviation and standard error measures as meaningful change estimates. Cross-sectional anchor-based analyses will categorize patients into clinically distinct groups based on clinical anchor scores; mean group differences in PROMIS-CA scores will represent MID estimates. Longitudinal anchor-based analyses will use clinical anchor changes to categorize patients; mean changes in PROMIS-CA scores will represent MID estimates. We will compare these empirically-derived MIDs to clinical activity data and symptom/functioning severity levels established by a panel of multidisciplinary clinical experts in a standard setting exercise.
Start Date: June 15, 2005
Complete Date: July 31, 2009
Study Design: Cohort
Time Perspective: Prospective
Enrollment Target: N=80 (short form only study); N=200 (CAT & short form study)
# Groups/Cohorts: 2
Outcome Measure: MID scores for PROMIS-CA measures: Pain Interference, Fatigue, Physical Function, Anxiety and Depression. Associations between MIDs and clinical activity data and symptom/functioning severity levels established by an expert clinical panel.
Group/Cohort Label: CAT & short form study; short form only study
Group/Cohort: Patient eligibility is the same for both sub-studies. Along with other measures, participants in the first sub-study complete the PROMIS-CA short forms; those in the second sub-study complete CAT & short forms.
Intervention Type: None
Study Population: Adults with any kind of cancer beginning a new outpatient cancer treatment.
Sampling Method: Non-probability sample
Eligibility Criteria: Inclusion: male or female; >= 18 years old; any cancer diagnosis; at or near the beginning of new treatment (up to first cycle); able to interact with a touch screen computer; able to read and understand English; signed and dated written informed consent prior to study participation.
Exclusion: Patients with any concurrent medical or psychiatric condition that may preclude participation in this study or completion of self-administered questionnaires (e.g., moderate to severe dementia and/or severe, uncontrolled schizophrenia). Patients whose planned treatment is not schedule to last through the course of the study.
Gender: Both
Age: 18 years or older
Facility: CORE, NorthShore University HealthSystem, Evanston, IL, USA
Investigators: David Cella, Ph.D., Principal Investigator, CORE
General Contact: Sofia Garcia, Ph.D., Project Director & Co-Investigator, CORE
sgarcia@northshore.org
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