Research Article

Real-World Evidence from the Integrative Medicine Primary Care Trial (IMPACT): Assessing Patient-Reported Outcomes at Baseline and 12-Month Follow-Up

Table 1

Summary of patient-reported outcome measures used in this study.

Measure

Short Form Health Survey 12-Item (SF-12)
Health-related quality of life measure comprising 12 items that yield overall General Health, Physical and Mental Component summary scores. General Health scores range from 0 (Poor) to 100 (Excellent). Physical and Mental Component Summary scores have an average of 50 and standard deviation of 10 in the general U.S. population. These scores are primarily based on the past 4 weeks. [9]
Perceived Stress Scale (PSS-4)
Four items yield a summary score of 0 to 16 – with higher scores indicating higher amount of perceived stress – considered representative of the general US population. Respondents are instructed to answer based on past month (4 weeks). [10, 11]
Stress Response and Amount
Two-item measure with combined ratings ranging from 0 to 12. Higher scores indicate higher stress or inability to handle stress. Stress amount item based on past year. [12]
Work Productivity & Activity Impairment (WPAI)
Seven item-measure of the percent of work productivity loss and impairment in daily activities over the past seven days due to health. WPAI examines two types of work productivity loss among employed respondents: absenteeism, which concerns the amount of time missed from work due to health reasons; and presenteeism, which concerns the amount of impairment while at work (i.e., reduced productivity) due to illness or other health related issues (e.g., pain, fatigue). The WPAI also combines absenteeism and presenteeism to provide an overall metric of work impairment. Impairment in daily activities is also measured separately for all respondents regardless of employment status. [13]
World Health Organization Well-Being Index (WHO-5)
Five-item measure of emotional well-being yielding an overall percentage score of 0 (worst possible) to 100 (best possible) based on past 2 weeks. Higher scores indicate higher well-being. [14]
Pain Visual Analog Scale (VAS)
Rated 0 = “No problem” to 10 = “Worst possible problem” based on today. [15]
Fatigue Visual Analog Scale (VAS)
Rated 0 = “No problem” to 10 = “Worst possible problem” based on past week.
Fatigue Severity Scale (FSS)
Completed if Fatigue VAS score is 5 or greater
Nine item rating summary containing response options ranging from 1 (“Strongly Disagree”) to 7 (“Strongly Agree”) based on the past week. [16]
Generalized Anxiety Disorder 2 (GAD-2)
Two item rating summary from 0 to 6 based on the past two weeks, with scores > 3 indicating need for further diagnostic evaluation. [17]
Patient Health Questionnaire 2 (PHQ-2 depression)
Two item rating summary from 0 to 6 based on the past two weeks, with scores > 3 indicating need for further diagnostic evaluation. [18]
Global Rating of Sleep Quality (Pittsburgh Sleep Quality Index [PSQI] item #9)
One item rating summary from 0 to 3 based on past month, with scores > 2 indicating need for further evaluation. [19]
Behavioral Risk Factor Surveillance System (BRFSS)
Five items assessing fruit and vegetable intake and nine items measuring exercise and physical activity based on past 30 days. [20]