Articles: function.
-
Randomized Controlled Trial
Estimating individualized treatment effects using a risk-modeling approach: an application to epidural steroid injections for lumbar spinal stenosis.
Conventional "1-variable-at-a-time" analyses to identify treatment effect modifiers are often underpowered and prone to false-positive results. This study used a "risk-modeling" approach guided by the Predictive Approaches to Treatment effect Heterogeneity (PATH) Statement framework: (1) developing and validating a multivariable model to estimate predicted future back-related functional limitations as measured by the Roland-Morris Disability Questionnaire (RMDQ) and (2) stratifying patients from a randomized controlled trial (RCT) of lumbar epidural steroid injections (LESIs) for the treatment of lumbar spinal stenosis into subgroups with different individualized treatment effects on RMDQ scores at the 3-week follow-up. Model development and validation were conducted in a cohort (n = 3259) randomly split into training and testing sets in a 4:1 ratio. ⋯ R2 values in the training set, testing set, and RCT were 0.38, 0.32, and 0.34, respectively. There was statistically significant modification ( P = 0.03) of the LESI treatment effect according to predicted risk quartile, with clinically relevant LESI treatment effect point estimates in the 2 quartiles with greatest predicted risk (-3.7 and -3.3 RMDQ points) and no effect in the lowest 2 quartiles. A multivariable risk-modeling approach identified subgroups of patients with lumbar spinal stenosis with a clinically relevant treatment effect of LESI on back-related functional limitations.
-
Poor family functioning has been reported to be associated with the severity of chronic pain in outpatients, but the association has not been fully addressed in general populations. The present study aimed to examine the association between family dysfunction levels and the presence of chronic pain in a community-dwelling Japanese population. ⋯ A biopsychosocial burden due to family relationships could worsen the clinical presentation of pain. Social support or family therapy for dysfunctional families would be a potential initiative for the prevention or management of chronic pain.