Utilizing a learning health system to capture real-world patient data: Application of the reliable change index to evaluate and improve the outcome of a pain rehabilitation program.

BACKGROUND AND OBJECTIVES: The learning healthcare system (LHS) has been developed to integrate patients' clinical data into clinical decisions and improve treatment outcomes. Having little guidance on this integration process, we aim to explain (a) an applicable analytic tool for clinicians to evaluate the clinical outcomes at a group and an individual level and (b) our quality improvement (QI) project, analyzing the outcomes of a new outpatient pain rehabilitation program ("Back-in-Action": BIA) and applying the analysis results to modify our clinical practice. METHODS: Through our LHS (CHOIR; https://choir.stanford.edu), we administered the Pain Catastrophizing Scale (PCS), Chronic Pain Acceptance Questionnaire (CPAQ), and Patient-Reported Outcomes Measures (PROMIS)® before and after BIA. After searching for appropriate analytic tools, we decided to use the Reliable Change Index (RCI) to determine if an observed change in the direction of better (improvement) or worse (deterioration) would be beyond or within the measurement error (no change). RESULTS: Our RCI calculations revealed that at least a 9-point decrease in the PCS scores and 10-point increase in the CPAQ scores would indicate reliable improvement. RCIs for the PROMIS measures ranged from 5 to 8 T-score points (i.e., 0.5-0.8 SD). When evaluating change scores of the PCS, CPAQ, and PROMIS measures, we found that 94% of patients showed improvement in at least one domain after BIA and 6% showed no reliable improvement. CONCLUSIONS: Our QI project revealed RCI as a useful tool to evaluate treatment outcomes at a group and an individual level, and RCI could be incorporated into the LHS to generate a progress report automatically for clinicians. We further explained how clinicians could use RCI results to modify a clinical practice, to improve the outcomes of a pain program, and to develop individualized care plans. Lastly, we suggested future research areas to improve the LHS application in pain practice.

Empowered Relief, cognitive behavioral therapy, and health education for people with chronic pain: a comparison of outcomes at 6-month Follow-up for a randomized controlled trial.

Introduction: We previously conducted a 3-arm randomized trial (263 adults with chronic low back pain) which compared group-based (1) single-session pain relief skills intervention (Empowered Relief; ER); (2) 8-session cognitive behavioral therapy (CBT) for chronic back pain; and (3) single-session health and back pain education class (HE). Results suggested non-inferiority of ER vs. CBT at 3 months post-treatment on an array of outcomes. Methods: Here, we tested the durability of treatment effects at 6 months post-treatment. We examined group differences in primary and secondary outcomes at 6 months and the degree to which outcomes eroded or improved from 3-month to 6-month within each treatment group. Results: Empowered Relief remained non-inferior to CBT on most outcomes, whereas both ER and CBT remained superior to HE on most outcomes. Outcome improvements within ER did not decrease significantly from 3-month to 6-month, and indeed ER showed additional 3- to 6-month improvements on pain catastrophizing, pain bothersomeness, and anxiety. Effects of ER at 6 months post-treatment (moderate term outcomes) kept pace with effects reported by participants who underwent 8-session CBT. Conclusions: The maintenance of these absolute levels implies strong stability of ER effects. Results extend to 6 months post-treatment previous findings documenting that ER and CBT exhibit similarly potent effects on outcomes.

Application of multidisciplinary team conference for neuromodulation candidates facilitates patient selection and optimization.

Introduction: Psychological evaluation is required by insurance companies in the United States prior to proceeding with a spinal cord stimulation or a dorsal root ganglion stimulation trial. Since January 2017, we implemented a Multidisciplinary Team Conference for Neuromodulation in our center to facilitate the collaboration between pain physicians and psychologists and to optimize screening of neuromodulation candidates. This study aims to report the impact of this team conference on improvement of neuromodulation outcome in our center. Methods: Appropriateness of neuromodulation were discussed in the team conference after initial visit with the pain specialist and psychological evaluation. For this study, we prospectively and retrospectively collected data on neuromodulation candidates who went through the team conference and those who did not as controls. Results: We discussed 461 patients in the team conference sessions from January 2017 to July 2023. Out of these, a spinal cord stimulator or a dorsal root ganglion stimulator trial was performed in 164 patients with 80.5% (132 cases) trial success rate leading to 140 implants. Out of these implants, 26 (18.6%) explanted and 21 (15%) required revision in 41 (29.3%) patients. We performed neuraxial neuromodulation trial for 70 patients without going through the team conference from January 2016 to July 2023 with a trial success rate of 45.7% (32 cases). In this group, 7 (21.9%) and 6 (18.8%) patients underwent explant and revision. The differences between the groups were statistically significant for trial success rate (odds ratio of 4.9 with p-value of <0.01) but not for explant (odds ratio of 0.8 with p-value of 0.627) or revision (odds ratio of 0.8 with p-value of 0.595). Conclusion: Implementing Multidisciplinary Team Conference increased trial success rate in our center. Team conference provides therapeutic benefit for patients, and also provides the opportunity for an educational discussion for trainees.

Comparison of a Single-Session Pain Management Skills Intervention With a Single-Session Health Education Intervention and 8 Sessions of Cognitive Behavioral Therapy in Adults With Chronic Low Back Pain: A Randomized Clinical Trial.

Importance: Chronic low back pain (CLBP), the most prevalent chronic pain condition, imparts substantial disability and discomfort. Cognitive behavioral therapy (CBT) reduces the effect of CLBP, but access is limited. Objective: To determine whether a single class in evidence-based pain management skills (empowered relief) is noninferior to 8-session CBT and superior to health education at 3 months after treatment for improving pain catastrophizing, pain intensity, pain interference, and other secondary outcomes. Design, Setting, and Participants: This 3-arm randomized clinical trial collected data from May 24, 2017, to March 3, 2020. Participants included individuals in the community with self-reported CLBP for 6 months or more and an average pain intensity of at least 4 (range, 0-10, with 10 indicating worst pain imaginable). Data were analyzed using intention-to-treat and per-protocol approaches. Interventions: Participants were randomized to (1) empowered relief, (2) health education (matched to empowered relief for duration and format), or (3) 8-session CBT. Self-reported data were collected at baseline, before treatment, and at posttreatment months 1, 2, and 3. Main Outcomes and Measures: Group differences in Pain Catastrophizing Scale scores and secondary outcomes at month 3 after treatment. Pain intensity and pain interference were priority secondary outcomes. Results: A total of 263 participants were included in the analysis (131 women [49.8%], 130 men [49.4%], and 2 other [0.8%]; mean [SD] age, 47.9 [13.8] years) and were randomized into 3 groups: empowered relief (n = 87), CBT (n = 88), and health education (n = 88). Empowered relief was noninferior to CBT for pain catastrophizing scores at 3 months (difference from CBT, 1.39 [97.5% CI, -∞ to 4.24]). Empowered relief and CBT were superior to health education for pain catastrophizing scores (empowered relief difference from health education, -5.90 [95% CI, -8.78 to -3.01; P < .001]; CBT difference from health education, -7.29 [95% CI, -10.20 to -4.38; P < .001]). Pain catastrophizing score reductions for empowered relief and CBT at 3 months after treatment were clinically meaningful (empowered relief, -9.12 [95% CI, -11.6 to -6.67; P < .001]; CBT, -10.94 [95% CI, -13.6 to -8.32; P < .001]; health education, -4.60 [95% CI, -7.18 to -2.01; P = .001]). Between-group comparisons for pain catastrophizing at months 1 to 3 were adjusted for baseline pain catastrophizing scores and used intention-to-treat analysis. Empowered relief was noninferior to CBT for pain intensity and pain interference (priority secondary outcomes), sleep disturbance, pain bothersomeness, pain behavior, depression, and anxiety. Empowered relief was inferior to CBT for physical function. Conclusions and Relevance: Among adults with CLBP, a single-session pain management class resulted in clinically significant improvements in pain catastrophizing, pain intensity, pain interference, and other secondary outcomes that were noninferior to 8-session CBT at 3 months. Trial Registration: ClinicalTrials.gov Identifier: NCT03167086.

Effectiveness of a multidisciplinary rehabilitation program in real-world patients with chronic back pain: A pilot cohort data analysis.

BACKGROUND: Randomized clinical trials (RCT) suggest a multidisciplinary approach to pain rehabilitation is superior to other active treatments in improving pain intensity, function, disability, and pain interference for patients with chronic pain, with small effect size (ds= 0.20-0.36) but its effectiveness remains unknown in real-world practice. OBJECTIVE: The current study examined the effectiveness of a multidisciplinary program to a cognitive and behavioral therapy (pain-CBT) in real-world patients with chronic back pain. METHODS: Twenty-eight patients (M𝑎𝑔𝑒= 57.6, 82.1% Female) completed a multidisciplinary program that included pain psychology and physical therapy. Eighteen patients (M𝑎𝑔𝑒= 58.9, 77.8% Female) completed a CBT-alone program. Using a learning healthcare system, the Pain Catastrophizing Scale, 0-10 Numerical Pain Rating Scale, and Patient-Reported Outcomes Measurement Information System® measures were administered before and after the programs. RESULTS: We found significant improvement in mobility and pain behavior only after a multidisciplinary program (p's < 0.031; d= 0.69 and 0.55). We also found significant improvement in pain interference, fatigue, depression, anxiety, social role satisfaction, and pain catastrophizing after pain-CBT or multidisciplinary programs (p's < 0.037; ds = 0.29-0.73). Pain ratings were not significantly changed by either program (p's > 0.207). CONCLUSIONS: The effect of a multidisciplinary rehabilitation program observed in RCT would be generalizable to real-world practice.