|Grant Number:||1R01CA174453-01 Interpret this number|
|Primary Investigator:||Reeve, Bryce|
|Organization:||Univ Of North Carolina Chapel Hill|
|Project Title:||Promis Validation in Prospective Population-Based Prostate Cancer Research Study|
DESCRIPTION (provided by applicant): Using innovative qualitative and quantitative methodologies, the Patient-Reported Outcomes Measurement Information System(r) (PROMIS(r)) initiative has developed high quality and clinically relevant patient-reported outcomes measures to be used to evaluate the impact of both disease and interventions on patients' lives. This study will add new knowledge of the reliability, validity, and responsiveness of PROMIS measures through an extensive psychometric evaluation within a population-based cohort of men with prostate cancer participating in a prospective comparative effectiveness research (CER) study. This includes a test of measurement equivalence across race, education, and age groups, as well as mode of administration of the PROMIS measures: via phone interviewer versus computer self-administered questionnaire. This evaluation will also include recently developed PROMIS domains including Sexual Function, Psychosocial Illness Impact, Sleep Related Impairment, and Gastro-Intestinal Symptoms - which are relevant for prostate cancer patients. In response to an Institute of Medicine report that indicated CER of prostate cancer treatments as a top 100 priority, the University of North Carolina was awarded a grant from the Agency for Healthcare Research Quality to conduct a prospective study. The North Carolina Prostate cancer Comparative Effectiveness & Survivorship Study is a population-based cohort of 1,400 prostate cancer patients with diverse race, education and age levels. Participants provide patient-reported data through phone interviews on their health-related quality of life (HRQOL) pretreatment, and at 3, 12, and 24 months post-treatment. These time points are critical as multiple studies have documented that many symptoms (i.e., sex, urinary, and bowel dysfunction; also fatigue, depression, anxiety) increase significantly from pretreatment to post-treatment, and then partially recover by 12 and 24 months. This trend provides an excellent opportunity to evaluate the responsiveness and to estimate minimally important differences of the PROMIS measures. The specific aims include: Aim 1: Evaluate the measurement properties of the PROMIS measures using item response theory models and other psychometric methods. Aim 2: Evaluate the ability of PROMIS measures to detect differences in health-related quality of life across age groups, race groups, treatment types, and comorbidity status. Aim 3: Evaluate the responsiveness of the PROMIS measures relative to legacy measures to detect clinically meaningful changes from baseline (pretreatment) through two years post-treatment. Aim 4: Test for measurement equivalence for the PROMIS measures for key prostate cancer subgroups including race, education, and age. Aim 5: Evaluate measurement equivalence across assessment modes of phone interview and computer self-administered survey. The multi-disciplinary team has extensive experience in psychometrics and prostate cancer care and research. Study results will significantly inform both the use of PROMIS in prostate cancer and provide key validation data on the PROMIS measures. PUBLIC HEALTH STATEMENT: Using innovative qualitative and quantitative methodologies, the NIH Patient-Reported Outcomes Measurement Information System(r) (PROMIS(r)) initiative has developed high quality and clinically relevant patient-reported measures to be used to evaluate the impact of both disease and interventions on patients' lives. This study will add new knowledge of the reliability, validity, and responsiveness of PROMIS measures through an extensive psychometric evaluation within a population-based cohort of men with prostate cancer participating in a prospective comparative effectiveness research (CER) study. Study results will provide key validation data on the PROMIS measures and will inform the adoption of PROMIS measures in prostate cancer CER and outcomes research.
Effect Of Glucagon-like Peptide-1 Receptor Agonists And Dipeptidyl Peptidase-4 Inhibitors On Colorectal Cancer Incidence And Its Precursors
Authors: Htoo P.T. , Buse J.B. , Gokhale M. , Marquis M.A. , Pate V. , Stürmer T. .
Source: European Journal Of Clinical Pharmacology, 2016 Aug; 72(8), p. 1013-23.
Comparison Of Diagnostic Evaluations For Cough Among Initiators Of Angiotensin Converting Enzyme Inhibitors And Angiotensin Receptor Blockers
Authors: Gokhale M. , Girman C. , Chen Y. , Pate V. , Funk M.J. , Stürmer T. .
Source: Pharmacoepidemiology And Drug Safety, 2016 May; 25(5), p. 512-20.
More Realistic Power Estimation For New User, Active Comparator Studies: An Empirical Example
Authors: Gokhale M. , Buse J.B. , Pate V. , Marquis M.A. , Stürmer T. .
Source: Pharmacoepidemiology And Drug Safety, 2016 Apr; 25(4), p. 462-6.
Trends In Prevalence And Determinants Of Potentially Inappropriate Prescribing In The United States: 2007 To 2012
Authors: Jirón M. , Pate V. , Hanson L.C. , Lund J.L. , Jonsson Funk M. , Stürmer T. .
Source: Journal Of The American Geriatrics Society, 2016 Apr; 64(4), p. 788-97.
Misinterpretation Of The Comparative Safety Of Testosterone Dosage Forms-reply
Authors: Layton J.B. , Stürmer T. , Brookhart M.A. .
Source: Jama Internal Medicine, 2015 Nov; 175(11), p. 1875-6.
Comparative Safety Of Testosterone Dosage Forms
Authors: Layton J.B. , Meier C.R. , Sharpless J.L. , Stürmer T. , Jick S.S. , Brookhart M.A. .
Source: Jama Internal Medicine, 2015 Jul; 175(7), p. 1187-96.
Short Look-back Periods In Pharmacoepidemiologic Studies Of New Users Of Antibiotics And Asthma Medications Introduce Severe Misclassification
Authors: Riis A.H. , Johansen M.B. , Jacobsen J.B. , Brookhart M.A. , Stürmer T. , Stĝvring H. .
Source: Pharmacoepidemiology And Drug Safety, 2015 May; 24(5), p. 478-85.
Serotonin-norepinephrine Reuptake Inhibitor And Selective Serotonin Reuptake Inhibitor Use And Risk Of Fractures: A New-user Cohort Study Among Us Adults Aged 50 Years And Older
Authors: Lanteigne A. , Sheu Y.H. , Stürmer T. , Pate V. , Azrael D. , Swanson S.A. , Miller M. .
Source: Cns Drugs, 2015 Mar; 29(3), p. 245-52.
Maternal Hormonal Contraceptive Use And Offspring Overweight Or Obesity
Authors: Jensen E.T. , Daniels J.L. , Stürmer T. , Robinson W.R. , Williams C.J. , Moster D. , Juliusson P.B. , Vejrup K. , Magnus P. , Longnecker M.P. .
Source: International Journal Of Obesity (2005), 2014 Oct; 38(10), p. 1275-81.
Trends In Glyburide Compared With Insulin Use For Gestational Diabetes Treatment In The United States, 2000-2011
Authors: Camelo Castillo W. , Boggess K. , Stürmer T. , Brookhart M.A. , Benjamin D.K. , Jonsson Funk M. .
Source: Obstetrics And Gynecology, 2014 Jun; 123(6), p. 1177-84.
The Challenges Of Comparing Results Between Placebo Controlled Randomized Trials And Non-experimental New User, Active Comparator Cohort Studies: The Example Of Olmesartan
Authors: Camelo Castillo W. , Delaney J.A. , Stürmer T. .
Source: Pharmacoepidemiology And Drug Safety, 2014 Apr; 23(4), p. 357-60.