title: Validation of a Patient-reported Outcome (PRO) Measure and a Clinician-reported Outcome (CRO) Measure to Assess Satisfaction with Pharmacologic Stress Agents for Single-photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI).
abstract: The objective of this study was to develop and validate clinician and patient measures of satisfaction for pharmacologic stress agents (PSAs) used in single-photon emission computed tomography myocardial perfusion imaging procedures.
  
  
  
  Two questionnaires were developed: the Clinician Satisfaction and Preference Questionnaire (CSPQ) and the Patient Satisfaction and Preference Questionnaire (PSPQ). Items were developed, and the content validity of the questionnaires was ensured by participants' involvement in the item generation (5 clinician and 18 patient face-to-face concept elicitation interviews) and item modification phases (5 clinician and 10 patient face-to-face cognitive debriefing interviews). Psychometric validation of the satisfaction component of the questionnaires was conducted in a sample of 9 clinicians and 90 patients.
  
  
  
  After initial patient interviews and cognitive interviews, two 8-item instruments were developed with each containing an optional PSA preference question. The PSPQ assessed patients' receptiveness and satisfaction with the PSA that they received. The CSPQ assessed clinicians' satisfaction with the time and ease of PSA preparation, administration, and monitoring of the PSA. The optional preference question in both instruments assesses preference among PSAs. In a multicenter observational study of 88 patients and 9 clinicians, the PSPQ Preparation and Reaction to Agent scales elicited reliability coefficients of 0.90 and 0.87, respectively. In addition, the test-retest reliability was acceptable for all PSPQ scales (intraclass correlation coefficient range, 0.73-0.86). Concurrent validity with the Treatment Satisfaction Questionnaire for Medication (TSQM) indicates 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, 0.46-0.78). Analysis of the CSPQ found that both the Preparation and Reaction to Agent subscales indicated strong internal consistency (α = 0.98 and 0.99, respectively).
  
  
  
  The PSPQ and CSPQ were developed and validated with rigorous methods. The instruments and their domains found strong internal consistency and good test-retest reliability. These questionnaires, when used as measures of treatment satisfaction in clinical trials, real-world observational studies, or by clinicians in their own laboratories, may help patients and clinicians better understand the impact of single-photon emission computed tomography myocardial perfusion imaging pharmacologic stress testing.
authors.affiliation: Clinical Outcomes Solutions, Tucson, Arizona. Electronic address: stacie.hudgens@clinoutsolutions.com.
authors.forename: Stacie
authors.initials: S
authors.lastname: Hudgens
authors.affiliation: Health Economics and Clinical Outcomes Research, Astellas Pharma Global Development, Northbrook, Illinois.
authors.forename: James
authors.initials: J
authors.lastname: Spalding
authors.affiliation: Health Economics and Clinical Outcomes Research, Astellas Pharma Global Development, Northbrook, Illinois.
authors.forename: Paresh
authors.initials: P
authors.lastname: Chaudhari
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D055414:Myocardial Perfusion Imaging / Q000379:methods*; D000071066:Patient Reported Outcome Measures; D017060:Patient Satisfaction; D011594:Psychometrics; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires; D015899:Tomography, Emission-Computed, Single-Photon / Q000379:methods*
keywords: CRO; PRO; clinician-reported outcome; patient-reported outcome; satisfaction; stress agents