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Table 3 Secondary outcomes measures

From: A digital health peri-operative cognitive-behavioral intervention to prevent transition from acute to chronic postsurgical pain in adolescents undergoing spinal fusion (SurgeryPalTM): study protocol for a multisite randomized controlled trial

Measure

Description

Respondent

Time point

T1

T2

T3

T4

Pediatric Quality of Life Inventory - Short form, acute versiona [32, 33]

15-item measure assessing health-related quality of life (HRQL) over the last 7 days across the following domains/subscales: physical health, psychosocial health, and total HRQL, reported on a 5-point Likert scale.

Adolescent

 

Opioid use [30]

2 items on the BPI assessing daily opioid use and pain relief from medications. Acute opioid use will be calculated as the number of days of opioid use during 14 days daily monitoring (T2).

Adolescent

NIDA-Modified ASSIST Toola [34, 35]

15-item measure assesses alcohol, smoking, substance, and opioid misuse in the past 2 weeks; additional questions about reasons for misuse (e.g., to treat pain, to get high, etc.) and source of opioids (e.g., prescription, from a friend or relative) will be used from the National Survey on Drug Use and Health [36].

Adolescent

 

PROMIS Pediatric Anxiety SF8a [37]

8-item measure used to assess adolescent self-reported anxiety. Adolescents endorse frequency of fear, anxiety, hyperarousal, and somatic symptoms experienced in the prior 7 days, on a 5-point Likert scale.

Adolescent

 

PROMIS Pediatric Depression SF8a [37]

8-item measure assess depressive symptoms. Frequency of negative mood, negative views of self, decreased positive affect, and decreased engagement in the prior 7 days reported on a 5-point Likert scale.

Adolescent

 

Patient Health Questionnaire-4a [38]

4-item screening measure of general anxiety and depressive symptoms experienced in the preceding 2 weeks by the respondent.

Adolescent, parent

 

Pain Catastrophizing Scale – Child Versiona [39]

13-item measure that assesses child pain catastrophizing. Adolescents report frequency of symptoms of rumination, magnification, and helplessness experienced when in pain using a 5-point Likert scale.

Adolescent

 

 

Pain Catastrophizing Scale – Parent Versiona [40]

13-item measure that assesses parents’ symptoms of rumination, magnification, and helplessness, in response to their child experiencing pain, on a 5-point Likert scale.

Parent

 

 

Adolescent Sleep Wake Scale 10a [41]

10–item measure of self-reported sleep quality in preceding month, including going to bed, falling asleep, reinitiating sleep, and returning to wakefulness using a 6-point Likert scale; four additional items from the Children’s Report of Sleep Patterns (CRSP) measure querying bedtime and wake time on weekdays and weekends will assess sleep duration [42].

Adolescent

 

Patient Global Impression of Severity Scalea

1-item assessing adolescent’s self-reported global impression of pain severity in the past 24 h (T2) or past week (T3 and T4), with response options “None” (0), “Mild” (1), “Moderate” (2), and “Severe” (3)

Adolescent

 

  1. aPediatric core Common Data Element (CDE) measures for the Help End Addiction Long Term (HEAL) Initiative. PROMIS, Patient-Reported Outcome Measurement Information System; NIDA, National Institute on Drug Abuse; ASSIST, Alcohol, Smoking and Substance Involvement Screening Test
  2. T1, pre-randomization baseline; T2, acute outcomes daily for 14 days post-hospital discharge; T3, chronic outcomes at 3 months post-surgery; T4, final follow-up at 6 months post-surgery