This study assessed patient and clinician satisfaction with three pharmacological stress agents (PSAs)-- regadenoson (REG), adenosine (ADE) and dipyridamole (DIP)— used in single photon emission computerized tomography myocardial perfusion imaging (SPECT-MPI), a non-invasive imaging test commonly used for the diagnosis and assessment of coronary artery disease. This multisite, non-interventional, non-randomized study involved patients undergoing PSA-facilitated SPECT-MPI and clinicians administering or assisting in the test. Patients completed two patient-reported outcome (PRO) questionnaires: the Patient Satisfaction Questionnaire (PSQ), to assess satisfaction with services provided at the site, and the Patient Satisfaction and Preference Questionnaire (PSPQ), to assess satisfaction specifically with the PSA. Clinicians completed one of two clinician-reported outcome (ClinRO) questionnaires: the Clinician Satisfaction and Preference Questionnaire (CSPQ; for physicians) or the modified CSPQ (mCSPQ; for nurses and technologists) to assess satisfaction utilizing a specific PSA. Differences on the PSPQ and PSQ between the PSAs were assessed using analysis of variance and Tukey tests. Differences on the CSPQ and mCSPQ with the PSAs were reported descriptively. Across 10 sites, 291 patients (n=147, 100, and 44 with REG, ADE and DIP, respectively), and 47 clinicians (physicians n=11; nurses/technologists n=36) participated. Patients receiving REG rated their satisfaction with services experienced at the site (PSQ) more favorably relative to those receiving ADE (p<.05). There were no significant pairwise differences for PSA-related Overall Satisfaction (PSPQ), but patients rated REG more favorably relative to ADE on Satisfaction with Administration (p<.05), and DIP more favorably relative to ADE for Visit Preparation (p<.05). Clinicians reported highest satisfaction for REG on Preparation, Administration, Monitor, Side Effects, and Overall Satisfaction domains of the CSPQ and mCSPQ. This study shows that clinicians and patients have quantifiable differences in satisfaction with PSAs. A cross-over clinical trial would be needed in order to measure actual preference between agents.

This study examined the psychometric properties of scores from three COAs assessing satisfaction with dobutamine for echocardiography. Previous work documented psychometric properties of these COAs to assess satisfaction with PSAs used with single-photon emission computed tomography myocardial perfusion imaging. This evaluation used data from 95 patients and 20 clinicians. Patients completed two questionnaires within 24-hours after the procedure: Patient Satisfaction and Preference Questionnaire (PSPQ) assessing PSA satisfaction, and the Patient Satisfaction Questionnaire (PSQ) assessing satisfaction with the site (for concurrent validity). Physicians completed the Clinician Satisfaction and Preference Questionnaire (CSPQ), and nurses/technicians completed the modified CSPQ (mCSPQ), within 2 weeks of site initiation. Though responses sometimes clustered at either the upper or lower end of item scales, results suggest that patients and clinicians utilized the range of responses available. For PSPQ, floor effects for the “Preparation” and “Reaction to Agent” domains were >40%. Ceiling effects for “Administration” “Effects” and “Overall Satisfaction” domains were also >40%, which implied high levels of satisfaction in these areas. For CSPQ, ceiling effects for “Image Quality” was 33.3%. Internal consistency was strong in most instances [PSPQ: “Preparation” (α=.93), “Reaction to Agent” (α=.40); CSPQ and mCSPQ: “Preparation” (α=.99, .99) and “Administration” (α=.93, .92). Inter-item correlations for PSPQ ranged from -0.01 to 0.96, which are small to strong; CPSQ ranged from 0.15 to 0.96, which are small to strong; mCPSQ ranged from 0.81 to 0.99, which are strong. Results suggest that when administered in real-world clinical settings, the PSPQ, CPSQ, and mCPSQ are capable of generating scores across the distribution of available responses (though clustering at upper and lower bound was observed in some instances), that are sufficiently reliable for most research purposes.

Patients with Hidradenitis Suppurativa (HS) experience painful abscesses and nodules primarily in the skin flexures, along with other disease-related impact and symptoms, which can further diminish their health-related quality of life. No HS-specific tools exist to assess those symptoms and impacts. We aimed to report the development and initial psychometric evaluation of the Hidradenitis Suppurativa Symptom Assessment (HSSA) and the Hidradenitis Suppurativa Impact Assessment (HSIA). The HSSA and HSIA were developed based on a literature review and concept elicitation interviews with HS patients (n=20). Following initial construction, the questionnaires were cognitively debriefed among HS patients (n=20) to test their readability and comprehensiveness. Next, the HSIA and HSSA were implemented in a multi-center, non-interventional study with HS patients (n=40) to evaluate their item and scale score distributions and indices of reliability and validity. The literature review and input from patients indicates that HS is associated with a range of symptoms (e.g., pain, drainage, itchiness) and impacts (e.g., difficulty with movement and interference with sexual activities). These concepts were organized into a conceptual model to facilitate the construction of the questionnaires. Results from the cognitive interviews indicated that both the HSSA and HSIA are easily understood by patients and characterize their condition well. Forty subjects completed the observational study (females = 58%; Caucasian = 65%; and age [mean] = 41 years). The HSIA and HSSA scores were found to perform well psychometrically, with strong evidence of test-retest (ICC=0.92 and 0.80, respectively) and internal consistency (α=0.97 and 0.96, respectively) reliability and known groups (P<0.001 and P<0.006, respectively) and construct-related validity (via correlations between the target measures and other, concurrently administered tools). There is robust evidence supporting the HSIA and HSSA as content valid and psychometrically sound questionnaires for assessing symptoms and impacts in patients with HS.

Mobility impairments affect most multiple sclerosis (MS) patients (93%), yet many patients (~40%) “rarely or never” discuss trouble walking with a health care provider (HCP). To facilitate patient-HCP dialogue and early identification of mobility impairments, the Early Mobility Impairment Questionnaire (EMIQ) was developed based on qualitative research with patients diagnosed with MS and in collaboration with key opinion leaders. To minimize the burden associated with administration of the EMIQ, psychometric analyses were applied to the initial draft to produce a parsimonious yet robust instrument. The EMIQ’s psychometric performance was evaluated in a multi-center, prospective, observational study in subjects with an Expanded Disability Status Scale (EDSS) score of 2.0 to 6.0. Iterative exploratory factor analysis (EFA) was used to guide item reduction; subsequently, an item response theory (IRT) graded response model was applied to confirm the robustness of the instrument. Logistic regression analyses (using EDSS scores) were used to confirm discriminatory power. In total, 124 subjects with moderate MS (EDSS mean score = 4.2) were included in the study. Discriminant validity, factor analysis, and IRT modeling identified six items for reduction. The resulting 9-item scale had one strong underlying domain (first eigenvalue explained 60% of variance). The information curve showed sufficient sensitivity (I>3.3 for -2.6≤θ≤2.4) throughout the scale (mild to severe), with the most precise information provided at ½ SD above the mean (I=12 at θ=0.4). Logistic regression showed that the EMIQ was able to discriminate between patients with and without walking impairment (p<0.05). The psychometric analyses resulted in a streamlined scale that is appropriate for the screening of subjects experiencing early mobility impairments due to MS. In addition to a potential role in guiding clinical assessment and intervention, the EMIQ may also prove useful in the longitudinal assessment of mobility, as patients’ conditions decline.

To test the reliability of the Patient Reported Scar Evaluation Questionnaire (PR-SEQ) in a general scar population at two time points and in two formats (pen/paper and electronic). The PR-SEQ, a 30-item 4-domain measure of scar experience, was administered to a total of 512 clinic- and self-recruited subjects with qualifying scars. The 101 clinic-recruited subjects were administered the PR-SEQ in a pen/paper format at Baseline and at Timepoint 1 (T1) and Timepoint 2 (T2) about 7 +/- 2 days apart using a computer-based version on the internet. The 413 self-recruited subjects were administered only the internet version at T1 and T2. Internal consistency reliability was assessed using Cronbach’s alpha for the total T1 cohort (n=512); test-retest reliability was assessed using the intraclass correlation coefficient (ICC) based on an ANOVA model for the T1-T2 retest cohort (n=359); and between forms reliability was assessed using the ICC for the clinic cohort data from baseline and T1 (n=100). Cronbach’s alpha was 0.96 for the PR-SEQ total score and 0.86 for Appearance (5 items), 0.68 for Symptoms (3 items), 0.92 for Bother (8 items), and 0.95 for Impact (14 items) domains. The ICC for the test-retest cohort was 0.85 for the total score and 0.76, 0.78, 0.80, and 0.81 for the domains of Appearance, Symptoms, Bother, and Impact, respectively. Between forms reliability was similarly acceptable with scores of 0.84, 0.90, 0.92, and 0.95 for the domains, and 0.94 for the total score. Overall, the two versions of the PR-SEQ demonstrated acceptable levels of reliability across the domains and total score, with the possible exception of the internal consistency of the 3-item Symptom domain. Further item reduction may be possible without significant risk to the reliability of the instrument.