Background & Aims
The Patient Global Impression of Change (PGIC) is considered a core outcome for pediatric pain clinical trials. However, PGIC has not been formally evaluated in pediatric populations with chronic pain. Efforts to validate, optimize, and standardize the measurement and analysis of PGIC are needed. This study aims were (1) to provide a literature review regarding existing use of different versions of the PGIC in clinical trials of pediatric chronic pain and (2) to empirically validate a specific PGIC measure used in two completed clinical trials testing psychological interventions for youth with chronic pain.
Methods
For aim 1, we conducted a literature search in four databases (i.e., Medline, Web of Science, Scopus, PsycInfo). Inclusion criteria were: 1) clinical trials in pediatric chronic pain, 2) used PGIC as an outcome, and 3) published until August 2023. We extracted information on the study population, PGIC measurement, and analytic approach.
For aim 2, we analyzed data from 2 clinical trials testing digital psychological interventions in pediatric chronic pain: Trial 1 included youth with any chronic pain (n=143, 11-17 y, 82% female) and Trial 2 included youth with sickle cell pain (n=111, 12-18 y, 59% female). Construct validity was evaluated by estimating the added variance in pain-related outcomes explained by PGIC. Responsiveness was indicated by differences in PGIC response categories between the intervention and control arms. Interpretability was examined by comparing PGIC response between trials and by age (10-14 vs 15-18 years) and sex (male vs female).
Results
Our search yielded 15 clinical trials. Two types of scale were identified: “Patient Global Impression of Change”(PGIC) and “Global Rating of Change”(GROC). Few studies specified the question posed to participants for either PGIC or GROC. Differences exist in the questions used between Farrar, 2001, and Hurst, 2004. Diverse response items and anchors were used.
Analysis of 2 trials revealed meaningful differences across trials. In Trial 1, at post-intervention and 3-months follow-up, PGIC response categories predicted additional variance in pain and insomnia symptoms (8.1-14.3%) and in depression and anxiety (2.7-8.1%) and differentiated between intervention and control groups (Ps <0.05). In Trial 2, PGIC predicted extra variance in depression, anxiety, and mobility at post-intervention and 6-months follow-up (12.1-20.9%), but not in pain, with no response differences between groups at either time. There was no difference in PGIC response categories across trials or by age and sex.
Conclusions
Despite inclusion as a core outcome to assess in pediatric pain clinical trials, there is a lack of standardized use and analysis of PGIC in trials of youth with chronic pain. Further, there is not a PGIC scale validated within pediatric populations with chronic pain. The variability in its use, and the lack of a specific instrument for pediatrics, has hindered any consensus about its use in pediatric clinical trials. Our analysis of the Hurst, 2004 PGIC scale presents preliminary validity data of the PGIC in youth with chronic pain. Findings provide preliminary evidence supporting the construct validity, responsiveness, and interpretability validity of this PGIC in youth with chronic pain, however, evidence is inadequate in youth with sickle cell pain. We conclude, providing recommendations for future studies that aim to use a validated PGIC as an outcome measure in pediatric pain clinical trials.
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Presenting Author
Guillermo Ceniza-Bordallo
Poster Authors
Topics
- Pain in Special Populations: Adolescents