Age, Race, Ethnicity, and Sex of Participants in Clinical Trials Focused on Chronic Pain.

There is limited data on equitable inclusion in chronic pain trials. We aimed to 1) identify the frequency of reporting age, race, ethnicity, and sex in clinical trials targeting chronic pain, and 2) compare sociodemographic representation to the United States (US) population. We examined US-based intervention trials for chronic pain initiated between 2007 and 2021 and registered on ClinicalTrials.gov. We 1) assessed the frequency of reporting each demographic variable, 2) compared representation with US population estimates, and 3) explored change in reporting over time. Of 501 clinical trials, the frequency of reporting was as follows: 36.9% reported older adults, 54.3% reported race, 37.4% reported ethnicity, and 100% reported sex. Rates of race and ethnicity reporting increased, but older adult age reporting decreased over time (ps < .00001). Compared to 2020 US population estimates, there was an equitable representation of older adults, under-representation of individuals identifying as American Indian or Alaska Native (.8% vs .6%), Asian (5.6% vs 2.9%), Black or African American (12.6% vs 12.2%), with more than one race (2.9% vs 1.2%), and Hispanic/Latino (16.9% vs 14.1%). There was an over-representation of individuals identifying as Native Hawaiian or Pacific Islander (.2% vs .5%) or White (70.4% vs 72.9%), and of females (50.8% vs 68.4%). Some representation rates varied by chronic pain condition. Reporting of older adult age, race, and ethnicity was low in chronic pain trials in ClinicalTrials.gov, reinforcing the need for adhering to reporting guidelines. Representation varied across trials compared with US population data, particularly among those identifying as Hispanic/Latino and certain minority racial groups. PERSPECTIVE: Despite initiatives to increase the reporting of demographic information, doing so in clinical pain trials is far from ubiquitous. Moreover, efforts to improve diversity in these trials continue to be insufficient. Indeed, Black, Indigenous, and People of Color (BIPOC) remain under-represented in clinical pain trials.

Perioperative insomnia trajectories and functional outcomes after total knee arthroplasty.

ABSTRACT: Longitudinal total knee arthroplasty (TKA) studies indicate that a substantial percentage of patients continue to experience clinically significant pain and functional impairment after surgery. Insomnia has been associated with poorer surgical outcomes; however, previous work has largely focused on long-term postsurgical insomnia. This study builds on previous work by examining sleep and pain outcomes about perioperative insomnia trajectories. Insomnia symptoms (using the Insomnia Severity Index) during the acute perioperative period (2 weeks pre-TKA to 6 weeks post-TKA) were used to classify participants into perioperative insomnia trajectories: (1) No Insomnia (ISI < 8), (2) New Insomnia (baseline < 8; postoperative ≥ 8 or ≥6-point increase), (3) Improved Insomnia (baseline ≥ 8, postoperative < 8 or ≥6-point decrease), and (4) Persistent Insomnia (ISI ≥ 8). Insomnia, pain, and physical functioning were assessed in participants with knee osteoarthritis (n = 173; M age = 65 ± 8.3, 57.8% female) at 5 time points: 2 weeks pre-TKA, post-TKA: 6 weeks, 3 months, 6 months, and 12 months. Significant main effects were seen for insomnia trajectory and time, and trajectory-by-time interactions for postoperative insomnia, pain severity, and physical functioning ( P' s < 0.05). The Persistent Insomnia trajectory had the worst postoperative pain at all follow-ups and marked insomnia and physical functioning impairment post-TKA ( P' s < 0.05). The New Insomnia trajectory had notable long-term insomnia (6 weeks to 6 months) and acute (6 weeks) postoperative pain and physical functioning ( P' s < 0.05). Findings indicated a significant relationship between perioperative insomnia trajectory and postoperative outcomes. Results of this study suggest that targeting presurgical insomnia and preventing the development of acute postoperative insomnia may improve long-term postoperative outcomes, with an emphasis on persistent perioperative insomnia due to poorer associated outcomes.

Let's Get Physical! A Comprehensive Review of Pre- and Post-Surgical Interventions Targeting Physical Activity to Improve Pain and Functional Outcomes in Spine Surgery Patients.

The goal of this comprehensive review was to synthesize the recent literature on the efficacy of perioperative interventions targeting physical activity to improve pain and functional outcomes in spine surgery patients. Overall, research in this area does not yet permit definitive conclusions. Some evidence suggests that post-surgical interventions may yield more robust long-term outcomes than preoperative interventions, including large effect sizes for disability reduction, although there are no studies directly comparing these surgical approaches. Integrated treatment approaches that include psychosocial intervention components may supplement exercise programs by addressing fear avoidance behaviors that interfere with engagement in activity, thereby maximizing the short- and long-term benefits of exercise. Efforts should be made to test brief, efficient programs that maximize accessibility for surgical patients. Future work in this area should include both subjective and objective indices of physical activity as well as investigating both acute postoperative outcomes and long-term outcomes.

Brief Mindfulness-Based Cognitive Behavioral Therapy is Associated with Faster Recovery in Patients Undergoing Total Knee Arthroplasty: A Pilot Clinical Trial.

OBJECTIVE: To assess whether brief mindfulness-based cognitive behavioral therapy (MBCBT) could enhance the benefits of total knee arthroplasty (TKA) in improving pain and pain-related disability. Specifically, to determine 1) whether patients who received MBCBT differed from matched controls who received treatment-as-usual with regard to postsurgical pain outcomes and 2) whether changes in pain catastrophizing, depression, or anxiety explained the potential effects of MBCBT on pain outcomes. DESIGN: Pilot clinical trial. SETTING: An academic teaching hospital serving a large urban and suburban catchment area surrounding the Boston, Massachusetts metropolitan region. SUBJECTS: Sample of 44 patients undergoing TKA. Patients who completed a brief MBCBT intervention (n = 22) were compared with age-, race-, and sex-matched controls who received treatment-as-usual (n = 22). METHODS: The MBCBT intervention included four 60-minute sessions delivered by a pain psychologist in person and via telephone during the perioperative period. Participants were assessed at baseline and at 6 weeks, 3 months, and 6 months after surgery. RESULTS: Compared with matched controls, patients who received MBCBT had lower pain severity and pain interference at 6 weeks after surgery. Group differences in outcomes were mediated by changes in pain catastrophizing but not by changes in depression or anxiety. The MBCBT group had similar reductions in pain severity and interference as the control group did at 3 and 6 months after surgery. CONCLUSIONS: This work offers evidence for a safe and flexibly delivered nonpharmacological treatment (MBCBT) to promote faster recovery from TKA and identifies change in pain catastrophizing as a mechanism by which this intervention could lead to enhanced pain-related outcomes.

Racial Differences in Psychological Symptoms and Eating Behaviors Among Bariatric Surgery Candidates.

BACKGROUND: Black patients typically lose less weight than White patients following bariatric surgery; however, the reasons for this racial disparity are unclear. The purpose of the current study was to evaluate whether there are differences in psychiatric symptoms and problematic eating behaviors between White and Black patients pursuing bariatric surgery as this may aid in understanding postsurgical weight loss disparities and inform psychosocial assessment of bariatric candidates. METHODS: A retrospective chart review was conducted of participants (N = 284) who completed a psychological evaluation prior to surgery. Information collected included history of binge eating and purging as well as data from measures administered (i.e., the Hospital Anxiety and Depression Scale, the Emotional Eating Scale, and the Yale Food Addiction Scale 2.0). RESULTS: White patients reported higher levels of eating in response to anger/frustration (p = .03) and eating in response to depression (p = .01) than Black patients. White patients also reported more symptoms of food addiction, a difference that was trending toward significance (p = .05). No significant differences were found on measures of anxiety or depression. CONCLUSION: White patients appear to have higher levels of presurgical problematic eating as compared with Black patients pursuing bariatric surgery; thus, these measurements of problematic eating may not explain the racial disparity in outcomes. However, future research should determine whether measures are valid among diverse populations and identify additional factors that may contribute to racial disparities in bariatric outcomes.

Socioeconomic and Racial Disparities in Bariatric Surgery.

The purpose of this study was to examine the associations among race and socioeconomic factors (receiving social security disability, insurance type, and income) with undergoing bariatric surgery and weight loss outcomes in a racially diverse, urban cohort of bariatric surgery candidates (N = 314). Patients with private insurance and who identified as Caucasian were more likely to undergo bariatric surgery. Income significantly predicted percentage of excess weight loss 1 year after surgery, although this was no longer significant when accounting for race. Race and socioeconomic factors should be considered during psychosocial evaluations to support patients at risk of surgical attrition and poorer weight loss outcomes. Future research should explore policy solutions to improve access, while qualitative work may help with understanding racial disparities in bariatric surgery.