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.

Productivity outcomes are of interest because they describe the consequence of disease in the workplace and impact on productivity. We conducted an analysis of work productivity (WP) endpoints in clinical studies. A keyword search was conducted on Clinicaltrials.gov for “work productivity” to identify relevant studies. Trials with terminated, withdrawn, or suspended status, those with non-drug interventions, and those without WP endpoints were excluded from analysis. A total of 170 studies were included (113 interventional and 57 observational studies). Of the 170 studies included, 44% were performed outside of the US, 31% were multinational studies including the US, and 25% were conducted exclusively in the US. The most common therapeutic categories investigated were autoimmune diseases (37%), neurology (14%), and psychiatry (9%). Most studies (84%) were sponsored by pharmaceutical manufacturers, with 11% sponsored by other institutions, or a combination of both (6%). The majority of trials investigated WP as a secondary measure (89%), with several, primarily observational studies, reporting WP as a primary outcome (11%). Survey instruments were utilized most commonly, representing 82% of studies, while 9% of studies evaluated WP based on time missed from work. Some studies utilized multiple measures. Generic instruments, such as the Work Productivity and Activity Impairment Questionnaire (WPAI), were used in 54% of studies, while 29% used disease-specific measures. In some cases (15%) a specific tool or instrument for WP was not identified. Most trials (93%) included other patient-reported endpoints, in addition to WP. WP endpoints were most commonly investigated in manufacturer-sponsored trials as secondary outcomes to demonstrate patient benefit in therapeutic areas where more concrete clinical outcomes are limited. Generic instruments are heavily utilized, with approximately one-third of studies utilizing disease specific measures.