Table 1.

Outcome Measures.

Outcome Measure Source	Measure Description	Collection Method and Timing
Pain experience (primary) • Brief Pain Inventory (BPI)	Four-item survey asking subjects to rate their worst pain, least pain, average pain, and current pain using a 11-point numeric rating scale (where 0 = no pain and 10 = worst pain)	• Preoperative survey • Patient-reported eDiary entries for first 7 evenings and 7 mornings during the postoperative period • Postoperative survey
Pain control satisfaction (primary) • Pain Treatment Satisfaction Scale (PTSS)	Six questions from the PTSS. Four items asked subjects to rate on a 5-point Likert scale (where 1 = very satisfied, 2 = satisfied, 3 = neither satisfied or dissatisfied, 4 = dissatisfied, and 5 = very dissatisfied) the time it took for the pain medication to work, the amount of pain relief provided by their pain medication, the duration of pain relief provided by their pain medication, and overall satisfaction with their pain medication. A fifth item using a 5-point Likert scale (where 1 = generally exceeds my expectations, 2 = somewhat exceeds my expectations, 3 = meets my expectations, 4 = does not quite meet my expectations, and 5 = does not meet my expectations at all) asks subjects to rate whether the level of pain relief met their expectations. The sixth item using a 5-point Likert scale (where 1 = definitely yes, 2 = probably yes, 3 = I don’t know, 4 = probably not, and 5 = definitely not) requests subjects to rate whether their pain medication could have been more effective.	• Postoperative survey
Ability to sleep • Pittsburgh Sleep Questionnaire (PSQ-3) • Numeric Rating Scale (NRS)	PSQ-3: 3-item survey asking subjects whether they had trouble falling asleep, were awakened by pain during the night, and whether they were awakened by pain in the morning (yes = 1/no = 0 response). NRS: Overall rating of a subject’s overall quality of sleep using the 11-point numeric scale where 0 = excellent and 10 = very poor.	• Preoperative survey • Patient-reported eDiary entries for first 7 mornings during the postoperative period
Pain interference • Patient Report Outcomes Measures Information System (PROMIS-6b)	Six-item survey using a 5-point Likert scale. Five items (using a Likert scale where 1 = not all, 2 = a little bit, 3 = quite a bit, 5 = very much) include how much did pain interfere with a subject’s enjoyment of life, ability to concentrate, day-to-day activities, recreational activities, and doing tasks away from home. A sixth item asking subjects if pain kept them from socializing with others used a 5-point Likert scale where 1 = never, 2 = rarely, 3 = sometimes, 4 = often, and 5 = always.	• Preoperative survey • Patient-reported eDiary entries for first 7 evenings during the postoperative period • Postoperative survey
Adverse events	Fifteen of the most common adverse events experienced when taking hydrocodone, ibuprofen, and acetaminophen	• Preoperative survey • Patient-reported eDiary entries for first 7 evenings and 7 mornings during the postoperative period • Postoperative survey