VALIDATION OF A PATIENT-REPORTED OUTCOME (PRO) MEASURE AND A CLINICIAN-REPORTED OUTCOME (CRO) MEASURE TO ASSESS SATISFACTION AND PREFERENCE WITH PHARMACOLOGICAL STRESS AGENTS FOR SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT) MYOCARDIAL ...
Author(s)
Hudgens S1, Kothari S21Mapi Values, Boston, MA, USA, 2Astellas Pharma US, Deerfield, IL, USA
OBJECTIVES: The objective of this study was to validate clinician and patient measures of satisfaction and preference for pharmacological stress agents (PSAs) used in Single Photon Emission Computed Tomography (SPECT) Myocardial perfusion imaging (MPI) procedures using classical and novel psychometric methods. METHODS: Psychometric validation of the Clinician Satisfaction and Preference Questionnaire (CSPQ) and the Patient Satisfaction and Preference Questionnaire (PSPQ) was conducted in a sample of 90 patients and 15 clinicians. Due to the small sample size, a Bayesian Item Response Theory was utilized to validate the initial parameter estimates. Specifically, item difficulty was evaluated using patient characteristics as the known prior distributions. RESULTS: The CSPQ demonstrated strong internal consistency (alpha=0.99) and moderate point-biserial correlations between PSA satisfaction scores and agent preference (range 0.63-0.65). The PSPQ ‘preparation’ and ‘reaction to agent’ scales demonstrated strong internal consistency (alpha=0.90 and 0.87 respectively). Test-retest reliability was acceptable for all PSPQ scales (ICC range=0.73 to 0.86). Concurrent validity with the Treatment Satisfaction Questionnaire for Medication (TSQM) indicate low to moderate correlations between the Effectiveness, Convenience and Global Satisfaction scales of the TSQM with the PSPQ Satisfaction with Administration, Satisfaction with Effects and Overall Satisfaction items (range 0.46 to 0.78). The results of the Bayesian analysis indicated consistency between the two approaches. Specifically, item difficulty was invariant across the various patient demographics. CONCLUSIONS: The CSPQ and PSPQ were developed and validated using rigorous, gold standard methodology. The resulting instruments sufficiently represents meaningful domains demonstrate strong internal consistency, good test-retest reliability, and predictive validity associated with clinician and patient measures of satisfaction and preference for pharmacological stress agents (PSAs) used in Single Photon Emission Computed Tomography (SPECT) Myocardial perfusion imaging (MPI) procedures. The variance in the item parameters were fully explained by the summary demographic information on the patients and physicians as supported by the Bayesian analysis.
Conference/Value in Health Info
2011-11, ISPOR Europe 2011, Madrid, Spain
Value in Health, Vol. 14, No. 7 (November 2011)
Code
PMD62
Topic
Patient-Centered Research
Topic Subcategory
Stated Preference & Patient Satisfaction
Disease
Cardiovascular Disorders