Pain Scores as Secondary Outcomes —Opioid Reduction Studies

To the Editor In their article describing the effects of telehealth mindfulness on opioid use reduction, Cooperman and colleagues include pain as a secondary outcome. Pain is assessed at baseline, 8 weeks, and 16 weeks using the Brief Pain Inventory (BPI), and twice daily throughout using Ecological Momentary Assessment (EMA). At baseline, BPI pain scores are 5.1 and 5.2 (intervention and comparison, respectively); initial EMA pain scores are 5.79 and 5.19, respectively. This potentially suggests either a pain spike in the intervention group or excessive variance. After treatment, EMA pain scores are 5.17 and 4.97 respectively; it appears that the treatment-induced pain decrease has brought treatment-group pain levels back to just above baseline. Interpretation is limited as final BPI values and EMA time course data are not provided. Although the provided protocol does not include specific timeline details, it is not uncommon for randomization to follow baseline testing; typically, this promotes baseline outcome similarity. If, as we postulate, randomization occurred after BPI baseline and before initial EMAs, then assignment to intervention, with frequent therapy and video-supervised drug testing, may have prompted elevated EMA pain scores. Perhaps treatment assignment had an impact, but clarifying data are not provided. A minor concern is that the study protocol proposed that BPI analysis would average all 4 elements at baseline, 8 weeks, and 16 weeks; instead, the article ...
Source: JAMA Psychiatry - Category: Psychiatry Source Type: research