Neuropsychological and biopsychosocial evolution, therapeutic adherence and unmet care needs during paediatric transplantation: study protocol of a mixed-methods design (observational cohort study and focus groups) - the TransplantKIDS mental health project.

The present article describes the protocol of a mixed-methods study (an observational cohort design and focus groups), aimed to examine neuropsychological functioning and other biopsychosocial outcomes, therapeutic adherence and unmet care needs in paediatric population undergoing solid organ or allogeneic hematopoietic transplant during the pre- and post-transplant phases. Following a multi-method/multi-source approach, neuropsychological domains will be comprehensively measured with objective tests (SDMT, K-CPT 2/CPT 3, TAVECI/TAVEC, WISC-V/WAIS-IV Vocabulary and Digit Span subtests, Verbal Fluency tests, Stroop, ROCF, and TONI-4); ecological executive functioning, affective and behavioral domains, pain intensity/interference, sleep quality and therapeutic adherence will be assessed through questionnaires (parent/legal guardians-reported: BRIEF-2 and BASC-3; and self-reported: BASC-3, BPI, PROMIS, AIQ and SMAQ); and blood levels of prescribed drugs will be taken from each patient's medical history. These outcomes will be measured at pre-transplant and at 4-weeks and 6-months post-transplant phases. The estimated sample size was 60 patients (any type of transplant, solid organ, or hematopoietic) from La Paz University Hospital (Madrid, Spain). Finally, three focus group sessions will be organized with patients, parents/guardians, and transplant clinicians (n = 15, with 5 participants per group), in order to qualitatively identify unmet care needs during the pre-, and post-transplant stages of the process. The study protocol was registered at ClinicalTrials.gov (NCT05441436).

Optimizing Pain Intensity Assessment in Clinical Trials: How Many Ratings are Needed to Best Balance the Need for Validity and to Minimize Assessment Burden?

Pain intensity is the most commonly used outcome domain in pain clinical trials. To minimize the chances of type II error (ie, concluding that a treatment does not have beneficial effects, when in fact it does), the measure of pain intensity used should be sensitive to changes produced by effective pain treatments. Here we sought to identify the combination of pain intensity ratings that would balance the need for reliability and validity against the need to minimize assessment burden. We conducted secondary analyses using data from a completed 4-arm clinical trial of psychological pain treatments (N = 164 adults). Current, worst, least, and average pain intensity in the past 24 hours were assessed 4 times before and after treatment using 0 to 10 numerical rating scale-11. We created a variety of composite scores using these ratings and evaluated their reliability (Cronbach's alphas) and validity (ie, associations with a gold standard score created by averaging 16 ratings and sensitivity for detecting between-group differences in treatment efficacy). We found that for each measure, reliability increased as the number of ratings used to create the measures increased and that ratings from 3 or more days were needed to have adequately strong associations with the gold standard. Regarding sensitivity, the findings suggest that composite scores made up of ratings from 4 days are needed to maximize the chances of detecting treatment effects, especially with smaller sample sizes. In conclusion, using data from 3 or 4 days of assessment may be the best practice. PERSPECTIVE: Composite scores made up of at least 3 days of pain ratings appear to be needed to maximize reliability and validity while minimizing the assessment burden. TRIAL REGISTRATION: clinicaltrials.gov NCT01800604.

ANF therapy® for pain management, feasibility, satisfaction, perceived symptom reduction and side effects: a real-world multisite observational study.

[Purpose] Non-invasive and drug-free interventions for pain are being developed. One of them is ANF (which stands for "Amino Neuro Frequency") Therapy®, which consists in the application of carbonized metal devices on a patient's skin. We aimed to: 1) test perceived changes in pain intensity after ANF application, 2) record frequency and severity of side effects, 3) assess clinician and patient satisfaction, 4) explore effects on swelling and range of motion (ROM). [Participants and Methods] In this real-world multisite observational study, N=113 physical therapists in 45 countries, applied ANF to N=1,054 patients (Mage=45.2, 56.2% female) with pain complaints. Demographic data, pain intensity (NRS-11), effects of ANF on swelling and ROM, clinician and patient satisfaction and side effects were collected. [Results] Main pain locations were: low back (14.9%), knee (12.4%), neck (10%), and shoulder (9.6%). Pre-treatment pain intensity was high (Mean=7.6, SD=1.9). It significantly decreased post-treatment (Mean=3.1, SD=2.0), t(1053)=7.25, with a large effect size (Cohen's d=2.2). Swelling decreased and ROM increased. Average satisfaction with ANF was 92/100. Patients often experienced mild side effects (42.3%): dry mouth, headache and fatigue. [Conclusion] Results show large effect sizes, high satisfaction, and mild and short-term side effects. This is very promising but should be interpreted with caution considering the study limitations.

Protocol for a multi-phase, multi-center, real-world, hybrid effectiveness-implementation study of a digital intervention for pediatric chronic pain co-designed with patients (Digital SPA).

Background: Children and adolescents with chronic pain are a vulnerable population who often lack the resources to manage their condition. Due to high personal, social, and economic consequences, proper management in its early stages is key to reducing disability. The aim of this project is to co-develop a digital intervention for pediatric chronic pain (Digital SPA) with end-users and to evaluate its effectiveness and implementation outcomes in Spain. Methods: (Phase 1) Focus groups with patients, parents, and clinicians (n = 5-6 each) will inform about unmet pain care needs and provide a starting point for co-designing the intervention. (Phase 2) Content creation and usability testing will be based on the results of Phase 1, and the theory-driven development will follow the latest available evidence. The intervention will use validated psychological techniques focused on improving functioning by teaching pain coping skills. (Phase 3) Hybrid effectiveness-implementation trial. Participants (n = 195) will be adolescents aged 12-17 years old with chronic pain and one of their parents. Assessments include physical function, pain, sleep, anxiety, mood, satisfaction and adherence to the treatment, and number of visits to the emergency room. A qualitative framework analysis will be conducted with data from Phase 1. Effects of the intervention will be evaluated using linear multilevel modeling. The Consolidated Framework for Implementation Research (CFIR) and Behavioral Interventions Using Technology (BIT) frameworks will be used to evaluate implementation. Discussion: This study is expected to produce a co-created evidence-based digital intervention for pediatric chronic pain and a roadmap for successful implementation. Trial registration number TRN and date of registration: ClinicalTrials.gov (registered on 26 June 2023: https://clinicaltrials.gov/study/NCT05917626). Contributions to the literature The implementation of digital health interventions has two major gaps: (1) adherence to treatment is suboptimal, and (2) the process of making the interventions available to the end-user in a sustainable way is often unsuccessful.In this study, we expect that assessing users' needs and co-designing an intervention with them will improve adherence.Documenting the implementation process from the project inception and integrating the results into an implementation framework will allow for replication and extension in different contexts.This study will increase the knowledge about implementation in a vulnerable population: adolescents with chronic pain without access to in-person multidisciplinary pain care.

Physicians' perception about predictors of opioid abuse in patients with chronic non-cancer pain: a Delphi study.

Background: Opioids are being prescribed widely, and increasingly, for the treatment of chronic non-cancer pain (CNCP). However, several side effects are associated with mid- and long-term opioid use and, for certain patients, with the risk of problematic opioid use. The aim of this study is to know the perception of the physicians about which variables could be associated with increased risk of patients with CNCP developing a problem of abuse or misuse of the prescribed opioid medication. Methods: Twenty-nine physicians with experience in CNCP pain management and opioids prescription participated in a two-round Delphi study focused on the risk factors for opioid misuse and abuse. Results: The variables that reached consensus regarding their relationship with the increased risk of suffering a problem of opioid abuse or misuse were: (1) Experiencing pain on a daily basis, (2) previous use of high-dose opioids, (3) generalized anxiety, (4) hopelessness, (5) benzodiazepine intake, (6) use of opioids for reasons other than pain, (7) family problems, family instability or family breakdown, and (8) having access to several opioid prescribers. The only variable that reached consensus regarding it not being associated to a possible risk of abuse or misuse was having mild pain intensity (0-4 on a NRS-11). Conclusions: This study provides useful information that could help make decisions about the use of opioids for CNCP treatment and prevent future difficulties. Prospective studies testing the relationship of the variables that reached consensus with the risk of opioid misuse and abuse are warranted. Significance: This study shows the variables of CNCP that the professional must take into account in order to avoid possible problems when prescribing opioids.

Mediating Role of Treatment Perceptions in the Relationship Between Individual Characteristics and Engagement With a Digital Psychological Intervention for Pediatric Chronic Pain: Secondary Data Analysis.

BACKGROUND: Engagement predicts benefits from self-managed treatments. However, engagement is an important concern in digital interventions, with over 50% of patients being nonadherent to interventions in chronic conditions such as chronic pain. Little is known about the individual characteristics that contribute to engagement with a digital self-management treatment. OBJECTIVE: This study tested the mediating role of treatment perceptions (difficulty and helpfulness) in the association between individual baseline characteristics (treatment expectancies and readiness to change) and treatment engagement (online and offline) with a digital psychological intervention for adolescents with chronic pain. METHODS: A secondary data analysis of a single-arm trial of Web-based Management of Adolescent Pain, a self-guided internet intervention developed for the management of chronic pain in adolescents, was conducted. Survey data were collected at baseline (T1), midtreatment (ie, 4 weeks after the treatment started; T2), and post treatment (T3). Online engagement was assessed using back-end information on the number of days adolescents accessed the treatment website, while the offline engagement was assessed with the reported frequency of use of skills (ie, pain management strategies) learned at the end of the treatment. Four parallel multiple mediator linear regression models, using ordinary least square regression incorporating the variables were tested. RESULTS: In total, 85 adolescents with chronic pain (12-17 years old, 77% female) participated. Several mediation models were significant in predicting online engagement. A significant indirect effect was found for the path expectancies-helpfulness-online engagement (effect 0.125; SE 0.098; 95% CI 0.013-0.389) and for the path precontemplation-helpfulness-online engagement (effect -1.027; SE 0.650; 95% CI -2.518 to -0.054). Fourteen percent of the variance of online engagement was explained by the model including expectancies as a predictor (F3=3.521; P<.05), whereas 15% was explained by the model where readiness to change was the predictor (F3=3.934; P<.05). Offline engagement was partially explained in the model including readiness to change as the predictor but with marginal significance (F3=2.719; R2=0.111; P=.05). CONCLUSIONS: Treatment perception, specifically, perceived helpfulness, was a mediator of the pathway between both treatment expectancies and readiness to change and online engagement with a digital psychological intervention for chronic pain. Assessing these variables at baseline and midtreatment may help to determine the risk of nonadherence. Further work is needed to confirm these mediation pathways in larger samples. TRIAL REGISTRATION: ClinicalTrials.gov NCT04043962; https://clinicaltrials.gov/ct2/show/NCT04043962.

Does pain catastrophizing and distress intolerance mediate the relationship between PTSD and prescribed opioid misuse in people with chronic noncancer pain?

OBJECTIVE: There is an ongoing debate on the use of long-term high-dose medically prescribed opioid analgesics for patients with chronic noncancer pain. Such use is elevated when there is comorbid pain and PTSD, which is quite prevalent. Therefore, it is relevant to investigate the psychological variables that may explain opioid misuse in this population. The purpose of this study was to examine the interaction effect of PTSD severity, distress intolerance, and pain catastrophizing on prescribed opioid misuse in chronic noncancer pain patients. METHOD: A total of 168 participants (M age = 60 years, 74% women) were assessed regarding opioid medication, pain intensity, traumatic psychological events, PTSD, distress intolerance, pain catastrophizing, and current opioid misuse. RESULTS: Groups were formed according to the level of PTSD severity (no symptoms, moderate symptoms, and severe symptoms). Significant differences were found between the groups in pain intensity, catastrophizing, distress intolerance, and opioid misuse. The severe-symptoms group had the highest scores on all variables. There were no between-group differences in the prescribed medication. Mediation analysis showed that the relationship between PTSD severity and opioid misuse was completely and independently mediated by distress intolerance and pain catastrophizing. CONCLUSIONS: Distress intciolerance and pain catastrophizing may be theoretically and clinically relevant constructs in understanding the motivation for opioid misuse in people with concurrent chronic noncancer pain and PTSD. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

A Mobile Application to Help Self-Manage Pain Severity, Anxiety, and Depressive Symptoms in Patients with Fibromyalgia Syndrome: A Pilot Study.

Treatment for individuals with fibromyalgia syndrome (FMS) is complex and is not always accessible to those who could benefit. The aim of this study was to conduct a preliminary evaluation of a mobile-app-delivered, cognitive behavioral treatment (CBT)-based intervention in helping adults self-manage fibromyalgia symptoms. A total of 100 adults with FMS (M [SD] age = 49.81, [9.99] years; 94% women) were given access to the digital treatment program and downloaded the app. Pain severity, anxiety symptoms, depression symptoms, fatigue, and sleep quality were assessed at pre-treatment, post-treatment, and 3-month follow-up. Fifty-three of the potential participants completed the 47-day treatment. Data showed significant improvements in pain severity (p = 0.007, d = 0.43), anxiety (p = 0.011, d = 0.40) and depressive symptoms (p = 0.001, d = 0.50) from pre-treatment to post-treatment. The effect sizes associated with app use are consistent with improvements seen in previously published clinical trials of CBT for FMS. Improvements were generally maintained, although there was some decrease in the outcomes from post-treatment to the 3-month follow-up. Most participants reported that they were very satisfied with the app. The use of the app was associated with similar levels of improvements found with in-person CBT treatment for FMS. Research to evaluate the effectiveness of the app in a controlled trial is warranted.

Baseline Sleep Disturbances Modify Outcome Trajectories in Adolescents With Chronic Pain Receiving Internet-Delivered Psychological Treatment.

Over 50% of adolescents with chronic pain report comorbid sleep disturbances (eg, difficulties with falling asleep), which is associated with increased pain-related disability and poorer quality of life. However, limited longitudinal data are available to understand how sleep disturbance may impact response to psychological treatment. Our primary hypothesis was that baseline sleep disturbances would significantly modify how adolescents responded to an internet-delivered psychological intervention for chronic pain in terms of outcome trajectories. The sample included 85 adolescents, 12 to 17 years, with chronic pain recruited from a multidisciplinary pain clinic and headache clinic who received access to an internet-delivered psychological intervention for chronic pain. Baseline sleep assessment included actigraphy monitoring for 7 days and survey measures. Outcomes were assessed at baseline, 8 weeks, and 3 months including core pain-related outcomes, executive functioning, fatigue, positive and negative affect. Results demonstrated that greater baseline insomnia and poorer sleep quality was associated with worse outcome trajectories for pain-related disability, depression, anxiety, fatigue, negative affect, and executive functioning. Findings extend the limited studies that examine how sleep disturbance may modify effectiveness of psychological treatments for adolescent chronic pain and emphasize the importance of treating comorbid sleep disturbance. This trial was registered at clinicaltrials.gov (NCT04043962). PERSPECTIVE: Our study suggests that sleep deficiency, in particular insomnia and poor sleep quality, may modify the effectiveness of psychological treatments for chronic pain, highlighting the urgent need to screen youth for sleep problems prior to initiating treatment, and to consider implementation of sleep-specific treatments such as cognitive-behavioral therapy for insomnia.

Diagnostic and Predictive Capacity of the Spanish Versions of the Opioid Risk Tool and the Screener and Opioid Assessment for Patients with Pain-Revised: A Preliminary Investigation in a Sample of People with Noncancer Chronic Pain.

INTRODUCTION: Accurate assessment of the risk of opioid abuse and misuse in people with noncancer chronic pain is crucial for their prevention. This study aimed to provide preliminary evidence of the diagnostic and predictive capacity of the Spanish versions of the Opioid Risk Tool (ORT) and the Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R). METHODS: We used the Current Opioid Misuse Measure (COMM) as criterion measure to assess the capacity of each tool to identify patients misusing opioids at the time of the assessment. Eighteen months later, we used the COMM and the Drug Abuse Screening Test-10 (DAST-10) to assess their predictive capacity. In total, 147 people with noncancer chronic pain participated in the diagnostic study, and 42 in the predictive study. RESULTS: Receiver operating curve analysis showed that the SOAPP-R had an excellent capacity to identify participants who were misusing opioids at the time of assessment (area under the curve [AUC] = 0.827). The diagnostic capacity of the ORT was close to acceptable (AUC = 0.649-0.669), whereas its predictive capacity was poor (AUC = 0.522-0.554). The predictive capacity of the SOAPP-R was close to acceptable regarding misuse (AUC = 0.672) and poor regarding abuse (AUC = 0.423). CONCLUSION: In the setting of Spanish-speaking communities, clinicians should be cautious when using these instruments to make decisions on opioid administration. Further research is needed on the diagnostic and predictive capacity of the Spanish versions of both instruments.

Development of the Pain Responses Scale: A measure informed by the BIS-BAS model of pain.

BACKGROUND: The behavioural inhibition system and activation system (BIS-BAS) model of pain focusses on two clusters of responses to pain-escape/avoidance (BIS) and approach (BAS) behaviours. While the BIS-BAS model emphasizes active responses to pain, deactivation responses such as despondence and relaxation are also common. This study sought to develop self-report scales assessing cognitive, behavioural intentions and affective responses to pain consistent with this extended BIS-BAS framework. We also sought to develop short-forms of the emerging scales. METHODS: Confirmatory factor analysis was performed to derive scales from a large item pool administered to a community sample with heterogeneous chronic pain (N = 476). RESULTS: The items resulted in 16 scales assessing Thoughts, Affective responses, Behavioural Intentions and Valence-Associated Thoughts, which loaded on to the four theorized types of pain responses-Escape, Approach, Despondence and Relaxation-with the four emerging short-form scales assessing these overarching factors. The internal consistency reliabilities of the long-forms generally ranged from good to excellent (αs ≥ 0.83), with the exception of the Relaxation-Behavioural Intentions scale (α = 0.64). The four short-forms demonstrated at least adequate internal consistency reliability (αs ≥ 0.79). An initial test of the construct validity of the scales in relation to pain-related outcomes is also reported. CONCLUSIONS: We anticipate that the Pain Responses Scale (PRS) developed from this research will be useful for assessing mechanisms targeted by many psychosocial pain treatments and will provide a nuanced understanding of the shared versus specific nature of these mechanisms. SIGNIFICANCE: The Pain Responses Scale emerging from this research assesses four theorized, overarching responses to pain: Escape, Approach, Giving Up and Relaxation. This measure will afford the capacity to test a reconceptualized BIS-BAS model of pain and inform treatments that are adapted based on this framework.

The prevalence of chronic pain in young adults: a systematic review and meta-analysis.

ABSTRACT: Previous systematic reviews have summarized the prevalence and impact of chronic pain in "average" pediatric (ie, school-age children) and adult (ie, middle-aged individuals) age groups. To the best of our knowledge, this is the first study to describe the prevalence of chronic pain in the subgroup of individuals who fall in between established boundaries of "childhood" and "adulthood"-known as young adulthood. The goal of this research was to meta-analyze prevalence data on pain in young adults based on available data published between 2008 and 2020. Searches were identified with MEDLINE, Embase, and PsycINFO. We included general population and university-based studies presenting prevalence estimates of chronic pain (pain lasting ≥3 months) in young adults. We identified 43 articles providing prevalence estimates across a combined population of 97,437 young adult respondents (age range: 15-34 years), with studies undertaken in 22 countries. Available data allowed for stratification of prevalence according to pain condition. The overall pooled random-effect prevalence rate of chronic pain in young adults was 11.6%, suggesting that 1 in every 9 young adults experience chronic pain worldwide. Prevalence rates varied considerably according to pain condition. Estimates did not vary according to sex, geographic location, and several study methodological characteristics (ie, population type, sampling area, sampling year, investigation period, and assessment method). Overall, young adult chronic pain is common and should be recognized as a major public health concern. Considering the difficulties young adults face accessing adult health care, greater attention is needed to develop transition programs and evidence-based treatments tailored to the unique needs of this age group.

The Silhouettes Fatigue Scale: a validity study with individuals with physical disabilities and chronic pain.

PURPOSE: Fatigue is known to interfere with function in individuals with physical disabilities. In order to monitor changes in fatigue over time and evaluate the efficacy of treatments, psychometrically sound measures of fatigue are needed. The aim of this work was to evaluate the validity of the Silhouettes Fatigue Scale with English instructions (SFS-EN) in a sample of adults with physical disabilities living in the USA. METHODS: Individuals with medical conditions associated with physical disabilities responded to an online survey that included the SFS-EN as well as another validated measure of fatigue (PROMIS short form-4a Fatigue Scale), and measures of pain intensity and pain catastrophizing. RESULTS: 523 individuals participated (mean age = 59.1 years; SD = 11.4). Most participants were Caucasian (89%), women (59%) and unemployed (71%). Results showed strong positive correlations between both measures of fatigue, supporting the convergent validity of the SFS-EN. In addition, the magnitude of this association was significantly greater than the association between the scores of the SFS-EN and the measures of pain intensity and pain catastrophizing, supporting the former's discriminant validity. CONCLUSIONS: The findings extend previous results supporting the SFS as a brief, easy to administer and understand, and valid measure of fatigue.IMPLICATIONS FOR REHABILITATIONFatigue is common in adults with physical disabilities and chronic pain.The Silhouettes Fatigue Scale (SFS) is a new single-item measure of general fatigue.Findings show that the SFS with English instructions (SFS-EN) is an easy to understand measure.Results support the convergent and discriminant validity of the SFS-EN score in adults with physical disabilities and chronic pain.

The Impairment and Functioning Inventory Revised-English version: A validation study in individuals with disabilities and bothersome pain.

BACKGROUND: Despite the relevance of daily function in individuals with chronic pain, few questionnaires have been designed to assess this domain in individuals with musculoskeletal pain. In addition, the Impairment and Functioning Inventory-Revised (IFI-R) is the only instrument that assesses perceived decreases in levels of daily activity after the onset of pain. OBJECTIVE: To evaluate the psychometric properties of the English version of the IFI-R. DESIGN: Cross-sectional study. SETTING: A database of individuals with medical conditions commonly associated with chronic pain maintained by the University of Washington. PATIENTS: A total of 470 individuals with chronic pain. METHODS: Factorial validity was analyzed by conducting a confirmatory factor analysis via structural equation modeling. Internal consistency was evaluated by calculating Cronbach's α coefficients. Convergent validity was assessed by calculating Pearson correlation coefficients between the two scales of the IFI-R and the Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference Scale. Criterion validity was analyzed by regression analysis via structural equation modeling. MAIN OUTCOME MEASURES: The English version of the IFI-R (IFI-R-EV) for individuals with chronic pain. RESULTS: The IFI-R-EV consists of 30 items with two related subscales: The Daily Function subscale (α = .86). and the Impairment subscale (α = .89). A significant correlation was found between these subscales and a measure of pain interference (r's = - .33, and .35 respectively; p's < .01). We also found statistically significant associations (p < .05) between daily function and depression (ß = -.14) and pain intensity (ß = -.13), between impairment and depression (ß = .14) and pain intensity (ß = .16), and between daily function and pain acceptance (ß = .14). CONCLUSIONS: The findings indicate that the IFI-R-EV provides valid and reliable measures of daily function and impairment in English-speaking individuals with a disability and chronic pain. These results are consistent with those obtained with the Spanish version.

A digital health peri-operative cognitive-behavioral intervention to prevent transition from acute to chronic postsurgical pain in adolescents undergoing spinal fusion (SurgeryPalTM): study protocol for a multisite randomized controlled trial.

BACKGROUND: Spinal fusion surgery is associated with severe acute postsurgical pain and high rates of chronic postsurgical pain in adolescents. Psychological distress, sleep disturbance, and low pain self-efficacy predict higher acute pain and likelihood of developing chronic postsurgical pain. Interventions targeting baseline psychosocial risk factors have potential to interrupt a negative trajectory of continued pain and poor health-related quality of life (HRQL) over time but have not yet been developed and evaluated. This randomized controlled trial will test effectiveness of a digital peri-operative cognitive-behavioral intervention (SurgeryPalTM) vs. education-control delivered to adolescents and their parents to improve acute and chronic pain and health outcomes in adolescents undergoing spine surgery. METHODS: Adolescents 12-18 years of age undergoing spinal fusion for idiopathic conditions, and their parent, will be recruited from pediatric centers across the USA, for a target complete sample of 400 dyads. Adolescents will be randomized into 4 study arms using a factorial design to SurgeryPalTM or education control during 2 phases of treatment: (1) pre-operative phase (one-month before surgery) and (2) post-operative phase (1 month after surgery). Acute pain severity and interference (primary acute outcomes) and opioid use will be assessed daily for 14 days following hospital discharge. Chronic pain severity and interference (primary acute outcomes), as well as HRQL, parent and adolescent distress, sleep quality, and opioid use/misuse (secondary outcomes), will be assessed at 3 months and 6 months post-surgery. DISCUSSION: Demonstration of effectiveness and understanding optimal timing of perioperative intervention will enable implementation of this scalable psychosocial intervention into perioperative care. Ultimately, the goal is to improve pain outcomes and reduce reliance on opioids in adolescents after spine surgery. TRIAL REGISTRATION: NCT04637802 ClinicalTrials.gov. Registered on November 20, 2020.

Does Pain Acceptance Buffer the Negative Effects of Catastrophizing on Function in Individuals With Chronic Pain?

OBJECTIVES: Pain catastrophizing and pain acceptance are psychological factors that have been shown to be associated with pain-related outcomes and predict multidisciplinary pain treatment outcomes. However, they are rarely examined in the same study. This study aimed to: (1) assess the independent roles of pain catastrophizingand pain acceptance as predictors of pain intensity, pain interference, and depression; and (2) evaluate the potential moderating role of pain acceptance on the association between pain catastrophizing and both pain and function. MATERIALS AND METHODS: A sample of 467 adults with chronic pain completed an online survey including measures of pain intensity, pain interference, depression, pain catastrophizing, and pain acceptance. RESULTS: Pain catastrophizing and pain acceptance were independent predictors of pain interference. Only pain catastrophizing and the activity engagement domain of pain acceptance were independent predictors of pain intensity and depression. Activity engagement moderated the association between pain catastrophizing and depression, indicating a buffering effect on the negative effects of catastrophizing on depression. Pain willingness moderated the association between pain catastrophizing and pain interference, such that endorsing low pain willingness may override any negative effects of pain catastrophizing. DISCUSSION: The findings suggest that pain catastrophizing and pain acceptance are independently important to adjustment to chronic pain. Research is needed to determine if treatments that target both for change are more effective than treatments that target only one.

Core outcome set for pediatric chronic pain clinical trials: results from a Delphi poll and consensus meeting.

Appropriate outcome measures and high-quality intervention trials are critical to advancing care for children with chronic pain. Our aim was to update a core outcome set for pediatric chronic pain interventions. The first phase involved collecting providers', patients', and parents' perspectives about treatment of pediatric chronic pain to understand clinically meaningful outcomes to be routinely measured. The second phase was to reach consensus of mandatory and optional outcome domains following the OMERACT framework. A modified Delphi study with 2 rounds was conducted including 3 stakeholder groups: children with chronic pain (n = 93), their parents (n = 90), and health care providers who treat youth with chronic pain (n = 52). Quantitative and qualitative data from round 1 of the Delphi study were summarized to identify important outcomes, which were condensed to a list of 10 outcome domains. Round 2 surveys were analyzed to determine the importance of the 10 domains and their relative ranking in each stakeholder group. A virtual consensus conference was held with the steering committee to reach consensus on a set of recommended outcome domains for pediatric chronic pain clinical trials. It was determined, by unanimous vote, that pain severity, pain interference with daily living, overall well-being, and adverse events, including death, would be considered mandatory domains to be assessed in all trials of any type of intervention. Emotional functioning, physical functioning, and sleep were important but optional domains. Last, the research agenda identifies several important emerging areas, including biomarkers. Future work includes selecting appropriate validated measures to assess each outcome domain.

Systematic Review: Psychosocial Correlates of Pain in Pediatric Inflammatory Bowel Disease.

BACKGROUND: Pain is a common symptom in pediatric inflammatory bowel disease (IBD) and is associated with poor health outcomes, yet additional knowledge about the psychosocial correlates of pain is needed to optimize clinical care. The purpose of this study is to systematically review the psychosocial factors associated with pain and pain impact in youth diagnosed with IBD within a developmentally informed framework. METHODS: Manual and electronic searches yielded 2641 references. Two authors conducted screening (98% agreement), and data extraction was performed in duplicate. Average study quality was rated using the National Institutes of Health Quality Assessment Tool. RESULTS: Ten studies (N = 763 patients; N = 563 Crohn disease, N = 200 ulcerative/ indeterminate colitis) met the inclusion criteria. Findings showed consistent evidence that higher levels of child depression symptoms and child pain catastrophizing were associated with significantly greater pain and pain impact (magnitude of association ranged from small to large across studies). Greater pain and pain impact were also associated with higher levels of child anxiety symptoms, child pain threat, child pain worry, and parent pain catastrophizing. Within the included studies, female sex and disease severity were both significantly associated with pain and pain impact. Study quality was moderate on average. CONCLUSIONS: There is evidence that child psychosocial factors are associated with pain and pain impact in pediatric IBD; more studies are needed to examine parent- and family-level psychosocial factors. Youth with IBD should be routinely screened for pain severity, pain impact, and psychosocial risk factors such as anxiety/depression.