Measures Of Pain Interference Research Articles

P041 DEVELOPMENT OF PROMIS PEDIATRIC PATIENT-REPORTED OUTCOME SHORT FORMS FOR FATIGUE AND PAIN INTERFERENCE IN CHILDREN WITH CROHN’S DISEASE

Abstract Introduction There is a need for reliable, valid patient-reported outcome (PRO) measures to assess the health and quality of life in pediatric Crohn’s disease (PCD). The development of PROs for this population may be facilitated by using Patient-Reported Outcomes Measurement Information System (PROMIS) item banks, which were developed using rigorous psychometric methods. We aimed to develop disease-specific PROMIS short forms by conducting qualitative research to identify the items that are most relevant to children with PCD. Methods Participants in an initial card sorting study included 42 children with CD (ages 8–17), 70 parents of children with CD, and 26 clinicians with expertise in CD. Using an online program, participants rated the importance of PROMIS items for pediatric CD patients. This exercise indicated that children, parents, and clinicians endorse Fatigue and Pain Interference items as important for PCD. In a separate study, trained research coordinators conducted one-on-one semi-structured interviews with 37 children with CD to further explore their experiences with fatigue and pain. Research coordinators also conducted one-on-one cognitive interviews with 14 children with CD. Each participant completed a questionnaire and then was interviewed about the reasoning for their answers. All interviews were transcribed and coded for meaning units, defined as conceptually distinct statements in the words of the participant. Results In semi-structured interviews, highly reported facets of fatigue and its impact included feelings of tiredness, friendships, and sports/exercise. Highly reported facets of pain and its impact included feelings of hurt, friendships, family, attention, and sports/exercise. Participants’ responses revealed the same breadth and types of lived experiences of fatigue and pain as children from the development samples drawn from the general population. Ratings of children’s reasoning and logic in cognitive interviews showed strong understanding of PROMIS items. Final item selection for the PCD-specific PROMIS short forms involved consideration of the concepts that participants identified as important, item understandability, psychometric evaluation of precision and coverage, and balance across different facets of each domain. Conclusions Results support the content validity and comprehensibility of PROMIS Pediatric Fatigue and Pain Interference measures in PCD. This work contributed to the development of 8-item short forms that are tailored to assess the lived experiences of fatigue and pain interference in PCD.

P052 VALIDITY AND INTERPRETABILITY OF PROMIS PEDIATRIC PATIENT-REPORTED OUTCOMES FOR CHILDREN WITH INFLAMMATORY BOWEL DISEASE

Abstract Introduction Patient-Reported Outcome Measurement Information System (PROMIS) instruments were developed using rigorous psychometric methods to assess health and quality of life across the life course. In two studies, we aimed to evaluate the clinical validity of PROMIS measures for children with inflammatory bowel disease (IBD) and to increase the interpretability of scores on these measures. Methods Study 1 recruitment and clinical data collection took place within 14 pediatric gastroenterology practices located across the United States. PROMIS Pediatric measures of Pain Interference, Fatigue, Psychological Stress Experiences, Global Health, and Life Satisfaction were completed by 1,049 children and youth (8–24 years old) with IBD and linked to an IBD registry that included disease activity measures. Study 2 utilized baseline data from a large, multi-center clinical trial to compare the effectiveness of anti-TNF monotherapy versus combination therapy with methotrexate. A total of 199 participants (8–20 years old) across 35 sites completed PROMIS Pediatric measures of Pain Interference, Fatigue, and Positive Affect. PROMIS measures were scored on a T-score metric (mean = 50; standard deviation = 10). Scores on symptom measures were classified as “severe” if they were at or above the 95th percentile, and scores on positive health measures were classified as “poor” if they were at or below the 5th percentile, relative to the United States general population of children ages 8–17. Results For nearly all domains across both studies, PROMIS scores were significantly associated with clinical measures of IBD severity. PROMIS measures indicated worse health and/or functioning with corresponding increases in disease activity (inactive to mild to moderate/severe). Comparisons between inactive and mild IBD groups resulted in medium or large effect sizes (Cohen’s d = 0.5 – 0.96) for Pain Interference, Fatigue, Psychological Stress, Global Health, and Life Satisfaction (Table 1). Proportions of children with IBD who were classified as “severe” or “poor” were higher than in the general population and increased with increasing levels of IBD severity (Table 2). Conclusions These studies support the clinical validity of PROMIS instruments for assessing the lived experiences of children with IBD. Effect sizes associated with differences between inactive and mild IBD translate to 5–10 points on the PROMIS T-scale, suggesting that 5–10 points is a clinically important difference between group average scores. To aid interpretation of an individual’s score, percentiles derived from the general population may be used to determine whether the score falls within the range of severe/poor scores for the measure.

Factors Related to Agreement Between Child and Caregiver Report of Child Functioning With Chronic Pain: PROMIS Pediatric and Parent Proxy Report.

Valid and efficient assessment of patient-reported outcomes remains a priority to guide pain treatment and research. PROMIS pediatric self-report and parent proxy measures offer feasible and rigorous evaluation of functioning in children with chronic conditions, including pain. A key challenge is determining the usefulness of multisource information from children and caregivers for understanding pain and function. Our primary aim examined child-caregiver agreement across child functioning domains. Our secondary aim examined child and caregiver factors associated with the child-caregiver agreement. A sample of 806 children with chronic pain (Mage=14.50 y; 72% female individuals) and a caregiver (Mage=45.82 y; 85% mothers) completed PROMIS pediatric self-report and parent proxy measures of anxiety, depression, fatigue, pain interference, and mobility before intake in an interdisciplinary outpatient pediatric chronic pain program. The agreement was poor to good depending on the evaluation method (effect size, intraclass correlation, and clinical significance interpretation). Caregivers generally reported worse child symptoms across domains compared with child self-report. The greatest discrepancy was observed for child anxiety, pain interference, and peer relations, with the greatest agreement for child mobility. The greater caregiver-child discrepancy was found for younger children, girls, with a higher child or caregiver pain catastrophizing, and poorer caregiver physical or mental health. Findings are discussed within the interpersonal context of pain and indicate the relevance of both child and caregiver perspectives to personalize chronic pain assessment and treatment. Findings can be used by clinicians and researchers to guide whether and how to integrate multi-informant reports about child chronic pain functioning.

A cohort study of the association between psychosocial factors and pain in patients with Spinal Cord Injury and Stroke.

To explore associations between psychosocial factors and pain intensity and pain interference in a population with a new neurological injury on admission to rehabilitation, and after six months. A longitudinal, prospective cohort study with participants with stroke or Spinal Cord Injury (SCI) completing questionnaires for pain intensity and interference, mental health, pain coping strategies and pain attitudes and beliefs within two weeks of admission to inpatient rehabilitation. After six months, participants completed measures of pain intensity and pain interference only. In all 32 participants completed the questionnaires at baseline and 19 after six months. Several associations between a person's mental health and certain beliefs were associated with pain outcomes. Additionally, poorer baseline mental health was associated with greater pain intensity and pain interference after six months, and a stronger belief in a medical cure for pain at baseline was associated with less pain intensity and pain interference after six months. Psychosocial factors are associated with pain early after stroke and SCI. Psychosocial factors are also associated with pain outcomes several months after stroke and SCI. This highlights the importance of psychosocial factors in both of these populations and their relationship with pain outcomes.

The vulnerability of executive functioning: The additive effects of recent non-restorative sleep, pain interference, and use of expressive suppression on test performance

Objective: Certain transient contextual factors (i.e. higher expressive suppression, pain, and non-restorative sleep) are all associated with temporary decrements in performance on measures of executive functioning (EF), making clinical interpretation of EF scores challenging. Additionally, pain, non-restorative sleep, and expressive suppression are thought to be mutually interrelated with one another and with depression. This study sought to investigate how these factors impact EF when considered simultaneously.Methods: A total of 95 community-dwelling older adults completed the Push-Turn-Taptap (PTT) task as a measure of EF, and self-report measures of expressive suppression, pain interference, non-restorative sleep, and depressive symptoms.Results: Expressive suppression and pain interference, but not non-restorative sleep, demonstrated unique relationships with EF performance when all factors were considered simultaneously. Expressive suppression fully mediated the relationship between non-restorative sleep and EF performance, but not when controlling for depression. When a single contextual burden composite was generated collapsing across transient contextual factors, a composite that included all three examined factors (i.e. including non-restorative sleep) accounted for more variance in EF scores beyond depression than a composite that only included expressive suppression and pain interference.Conclusion: Expressive suppression, pain interference, and non-restorative sleep share some overlap with one another and with depression, but nonetheless have an additive negative effect on EF performance beyond depression. Quantifying these transient contextual factors may improve the accuracy of EF assessment and, by extension, the utility of EF measures in predicting daily functioning. These transient contextual factors also represent targets that, if better managed, may reduce EF lapses in daily life.

An analysis of psychotherapies delivered online and in person for patients with chronic pain: protocol for a systematic review and network meta-analysis.

Introduction: There is increasing evidence for the use of psychotherapies, including cognitive behavioural therapy, acceptance and commitment therapy, and mindfulness based stress reduction therapy, as an approach to management of chronic pain. Similarly, online psychotherapeutic interventions have been shown to be efficacious, and to arguably overcome practical barriers associated with traditional face-to-face treatment for chronic pain. This is a protocol for a systematic review and network meta-analysis aiming to evaluate and rank psychotherapies (delivered in person and online) for chronic pain patients. Methods/ design: Four databases, namely the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and PsycINFO will be searched from inception. Randomised controlled trials that have evaluated psychological interventions for pain management delivered online or in person will be included in the review. Data will be independently extracted in duplicate and the Cochrane Collaboration Risk of Bias Tool will be used to assess study quality. Measures of pain interference will be extracted as the primary outcome and measures of psychological distress will be extracted as the secondary outcome. A network meta-analysis will generate indirect comparisons of psychotherapies across treatment trials. Rankings of psychotherapies for chronic pain will be made available. Discussion: A variety of psychotherapies, delivered both online and in person, have been used in an attempt to help manage chronic pain. Although occasional head to head trials have been conducted, little evidence exists to help identify which psychotherapy is most effective in reducing pain interference. The current review will address this gap in the literature and compare the psychotherapies used for internet delivered and in person interventions for chronic pain in relation to the reduction of pain interference and psychological distress. Results will provide a guide for clinicians when determining treatment course and will inform future research into psychotherapies for chronic pain. PROSPERO registration: CRD42016048518 01/11/16.

Spasticity and pain in adults with cerebral palsy.

To evaluate whether spasticity measures are related to pain in adults with cerebral palsy (CP). This cross-sectional study recruited individuals aged 16 to 89years with a diagnosis of CP. Participants completed the Penn Spasm Frequency Scale (PSFS), Brief Pain Inventory (BPI), and PROMIS Pain Interference measures. The Modified Ashworth Scale (MAS) and Tardieu spasticity angles of six joints were rated and summed to composite MAS and Tardieu scores for each participant. Associations between spasticity and pain measures were evaluated. Forty-seven participants (27 females, 20 males) with a mean age of 35years 7months (range 18-77y) spanning all Gross Motor Function Classification System (GMFCS) levels were included. Twenty-six participants reported their average pain level on BPI as greater than 0 over the past week (median pain level 4.0). Median PSFS was 1.0 (range 0.0-1.0) and this correlated with average BPI and Pain Interference T scores (median 40.7; ρ=0.33 and ρ=0.31 respectively [both p=0.01]). When adjusted for pain medication use and age, MAS correlated with BPI (ρ=0.30; p=0.04). Other pain and spasticity measures, or GMFCS level, were not significantly related with pain interference or BPI rating. Age was weakly associated with BPI (slope=0.10; p<0.01). PROMIS Pain Interference was lower than population-based norms. Patient-rated spasm frequency demonstrated better association with pain levels and interference than physician-rated MAS and Tardieu. Pain was not associated with Gross Motor Function Classification System level. Pain increased with age, as anticipated. Self-reported spasm scores were associated with increased pain in contrast to clinical examination scales. Adjusted, summed spasticity on the Modified Ashworth Scalewas associated with painscores on the Brief Pain Inventory. Although pain is experienced by adults with cerebral palsy, pain did not interfere with activities.

Pain interference may be an important link between pain severity, impairment, and self-reported disability in participants with wrist/hand pain

Study DesignCross-sectional. IntroductionPain severity, sensory and motor impairment, and psychological (distress and anxiety) and social factors have previously been related to self-reported disability in persons with wrist and hand pain. Purpose of the studyThe purpose of this study to determine the relative contribution of pain severity, measures of impairment (sensory and motor function), psychosocial factors, and pain interference on self-reported disability experienced by persons with heterogeneous orthopedic injuries and conditions of the wrist and hand. MethodsMeasures of disability and pain severity as well as measures of sensory (pressure pain thresholds, joint position sense), motor (grip strength, Purdue pegboard), and cognitive performance (Stroop test) and psychosocial variables related to pain and participation (West Haven-Yale Multidimensional Pain Inventory) were administered to 60 participants with wrist and hand pain. Pearson product correlations controlled for age and sex, and multiple linear regression was performed to determine the relationship between measures of impairment, pain severity, psychosocial variables, and pain interference with self-reported disability assessed with the Disability of Arm, Shoulder and Hand (DASH) questionnaire. ResultsThe best-fitting regression model with DASH scores entered as the dependent variable (F4,50 = 28.8, P < .01) included MPI Pain Interference (β = −0.54), Life Control (β = −0.16), Purdue pegboard scores (β = −0.32), and Stroop test times (β = 0.21). Pain Interference had the strongest correlation with self-reported disability (adjusted R2 = 0.67, P < .01). ConclusionPain interference appears to be an important factor explaining the link between impairment, pain severity, and self-reported disability. Addressing pain interference may be important to improve outcomes in this population.

53. Comparison of generic vs spine-specific pain surveys administered before surgery and fulfillment of expectations measured after surgery for lumbar degenerative spondylolisthesis

BACKGROUND CONTEXT Generic and spine-specific surveys are used before surgery for lumbar degenerative spondylolisthesis (LDS) to measure pain. While both types of surveys can discern various aspects of pain, such as pain intensity and pain-associated disability, their ability to capture how pain impacts other outcomes, such as fulfillment of expectations, is not known. PURPOSE To determine which pain surveys are most closely associated with fulfillment of expectations after surgery for LDS. STUDY DESIGN/SETTING Prospective 2-year longitudinal study, tertiary spine center. PATIENT SAMPLE A total of 146 patients undergoing surgery for LDS. OUTCOME MEASURES HSS Lumbar Spine Surgery Expectations Survey. METHODS Patients were interviewed several days before surgery with the valid 20-item Expectations Survey addressing symptoms, physical function, and psychological well-being. Patients rated how much improvement they expected for each item with response options of complete to no improvement. To measure pain, patients completed back-specific measures of global pain with a numeric rating scale (0-10) and the modified Oswestry Disability index (ODI) (0-100), and generic PROMIS measures of Pain Intensity and Pain Interference with computer adapted tests (T scores 50). Medical records were reviewed for surgeon-reported pain on flexion/extension and surgical complexity according to the Invasiveness Index (max 10 points/vertebral level). Two-year postop patients again completed the Expectations Survey rating how much improvement they actually received. A proportion of expectations fulfilled was calculated as total improvement received divided by total improvement expected (range 0 (no improvement), 1 (improved as expected), >1 (improved more than expected). In multivariable linear regression analyses controlling for complexity, the proportion was the dependent variable and various pain measures were independent variables, expressed as estimates with desired 95% confidence intervals (CI) not to cross 0. RESULTS Mean age was 68, 61% were women, 82% had LDS at only one level (69% L45), mean pelvic incidence was 61° (30-84), mean pelvic incidence minus lumbar lordosis was 10° ((-16)-50), and the median surgical complexity was 7 (1-22). With respect to pain, 60% of patients had pain with extension, 25% with flexion. The median global back pain was 6 (0-10), and mean values were: ODI 50 (6-88), PROMIS Intensity 55 (31-72), and PROMIS Interference 63 (3-100). The mean time to follow-up was 2.1 years. The mean Expectations Survey proportion of expectations fulfilled was .99 (0-3.53); 42% of patients had low, 21% had equivalent, and 36% had high proportions (ie, greater expectations fulfilled). Controlling for surgical complexity, higher proportions were associated with less ODI pain (1.1, CI 0.5-1.6, p=.0001), less global back pain (4.5, CI 1.6-7.3, p=002) and, to lesser extents, less generic PROMIS Pain Intensity (1.5, 0.3-2.6, p=.01) and Pain Interference (0.8, -0.1-1.6, p=.08). There were no associations between surgeon-reported pain on extension/flexion and proportions of expectations fulfilled (p>.10). CONCLUSIONS Compared to generic pain surveys, preop pain measured by spine-specific pain surveys were more closely associated with the outcome of fulfillment of expectations. Whether generic pain surveys, such as PROMIS, are sufficiently sensitive to explain other outcomes of LDS needs to be assessed further. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

Weight Gain Trajectory and Pain Interference in Young Adulthood: Evidence from a Longitudinal Birth Cohort Study.

Obesity is associated with chronic pain, but the contribution of body mass index (BMI) trajectories over the life course to the onset of pain problems remains unclear. We retrospectively analyzed how BMI trajectories during the transition to adulthood were associated with a measure of pain interference obtained at age 29 in a longitudinal birth cohort study. Data from the National Longitudinal Survey of Youth, 1997 Cohort (follow-up from 1997 to 2015), were used to determine BMI trajectories from age 14 to 29 via group trajectory modeling. At age 29, respondents described whether pain interfered with their work inside and outside the home over the past four weeks (not at all, a little, or a lot). Multivariable ordinal logistic regression was used to evaluate pain interference according to BMI trajectory and study covariates. Among 7,875 respondents, 11% reported "a little" and 4% reported "a lot" of pain interference at age 29. Four BMI trajectory groups were identified, varying in starting BMI and rate of weight gain. The "obese" group (8% of respondents) had a starting BMI of 30 kg/m2 and gained an average of 0.7 kg/m2/y. On multivariable analysis, this group was the most likely to have greater pain interference, compared with "high normal weight" (odds ratio [OR] = 1.47, 95% confidence interval [CI] = 1.14-1.88), "low normal weight" (OR = 1.45, 95% CI = 1.13-1.87), and "overweight" trajectories (OR = 1.33, 95% CI = 1.02-1.73). Obesity and rapid weight gain during the transition to adulthood were associated with higher risk of pain interference among young adults.

Assessing Perceived Success in Valued Living in Individuals With Long-Term Physical Health Conditions.

Objective: To evaluate the reliability and validity of a brief measure of successful aging in a sample of adults with long-term health conditions. Method: The brief (eight-item) version of the valued living scale (VLS) and measures of pain intensity, pain interference, and depression were administered to 1,457 adults aging with one of four long-term health conditions. Results: Analyses indicated that the VLS items assessed two types of valued living domains: (a) a social and relational domain and (b) a health and productivity domain. The findings also supported the construct validity for the VLS items, in that both domains were associated significantly (and negatively) with the measures of pain intensity, pain interference, and depression. Discussion: The results provide preliminary support for the reliability and validity of the VLS items for assessing two important domains of successful aging in individuals with long-term health conditions.

PROMIS correlation with NDI and VAS measurements of physical function and pain in surgical patients with cervical disc herniations and radiculopathy.

The aim of this study was to compare the patient-reported outcome measures Neck Disability Index (NDI) and visual analog scale (VAS) with the Patient Reported Outcomes Measurement Information System (PROMIS) physical function (PF) and pain interference (PI) measures, respectively, and to determine their correlations in a surgical population longitudinally.Legacy outcome measures such as NDI and VAS are essential for analyzing treatments in spine surgery for cervical disc herniations with radiculopathy. Despite their usefulness, administrative burdens impose limits on completion of these measures. PROMIS was developed as a patient outcome measure in order to improve reporting of patient symptoms and function and to reduce administrative burden. Despite early positive results of PROMIS in orthopedics, NDI and VAS scores have not been compared with PROMIS scores in patients with cervical disc herniations with radiculopathy. Eighty patients undergoing surgery for cervical disc herniations with radiculopathy were included. All patients were treated at the same tertiary spine center. Patients were seen and PROMIS PF and PI, NDI, and VAS arm and neck pain scores were collected preoperatively and at 1 year postoperatively. Correlations between NDI, VAS, and PROMIS PF and PI were quantified using Pearson correlation coefficients. Two-tailed Student t-tests were used to demonstrate correlation significance, with alpha = 0.05. All 80 (100%) patients completed all preoperative questionnaires. Fifty-seven (72%) and 75 (94%) patients completed all questionnaires at baseline and at the 6-month and 1-year follow-ups, respectively. PROMIS PF and NDI scores demonstrated a strong negative correlation, with Pearson r values of -0.81, -0.77, and -0.75 at baseline, 6 months, and 1 year. PROMIS PI and VAS neck pain scores demonstrated a moderately positive correlation, with Pearson r values of 0.51, 0.61, and 0.6. PROMIS PI and VAS arm pain scores demonstrated a moderately positive correlation, with Pearson r values of 0.46, 0.47, and 0.45. PROMIS PF scores have a strong negative correlation with NDI scores at baseline and in the postoperative course in patients undergoing surgery for cervical disc herniations with radiculopathy. PROMIS PI scores have a moderately positive correlation with VAS neck and arm pain scores at baseline and in the postoperative course. Surgeons may factor these correlation results into the interpretation of patient-reported outcome measures in patients with cervical radiculopathy. Use of PROMIS PF and PI for this patient population may reduce administrative burden while providing reliable outcomes data.

The Mediating Effect of Pain Catastrophizing on PTSD Symptoms and Pain Outcome.

Coprevalence of chronic pain and posttraumatic stress disorder (PTSD) negatively impacts the course of both disorders. Patients diagnosed with both conditions report greater pain, affective distress, and disability when compared with those with either chronic pain or PTSD alone. While the prevalence and complexity of the comorbidity is widely acknowledged, there is a dearth of research examining potential mechanism variables that might account for the relationship between chronic pain and PTSD. The current study utilizes a series of mediation analyses to examine if pain catastrophizing mediates the relationship between PTSD symptomatology and chronic pain outcome. A total of 203 treatment-seeking participants admitted to a 3-week interdisciplinary pain rehabilitation program completed a battery of psychometrically validated measures of pain severity, pain interference, pain catastrophizing, depressive symptoms, and PTSD symptoms at program admission. A series of multiple parallel mediation analyses revealed that pain catastrophizing fully mediated the relationships between PTSD symptoms and pain outcome (ie, pain severity and pain interference) above and beyond the influence of depressive symptoms. Results suggest that pain catastrophizing may represent an important cognitive mechanism through which PTSD symptoms influence the experience of chronic pain. Psychosocial treatment approaches that directly target tendency to catastrophize in response to pain may hold the potential to have salutary effects on both chronic pain and PTSD.

Do Commonly Used Measures of Pain Intensity Only Reflect Pain Intensity in Youths With Bothersome Pain and a Physical Disability?

The objective of this cross-sectional study was to evaluate the extent to which non-pain intensity factors influence the ratings of pain intensity on two commonly used measures: the Wong-Baker Faces pain rating scale (FACES) and the Verbal Rating Scale (VRS) in a sample of youths with physical disabilities and bothersome pain. Study participants came from a convenience sample of 115 youths (age: = 14.4 years; SD = 3.3), who participated in a survey on the impact of pain in young people with a physical disability. They were administered measures of pain intensity, pain catastrophizing, depressive symptoms, pain interference, and pain control beliefs. Zero-order correlation analyses were used to examine the associations among the pain intensity scores, while regression analyses were used to test the influence of the non-pain intensity factors on the pain intensity scores. Although pain intensity scores from all scales were significantly associated with one another, the correlations were moderate. Regression analyses showed that the FACES and VRS also reflect pain interference, in addition to pain intensity. The fact that the FACES and VRS ratings reflect more than pain intensity should be considered when selecting a pain measure. The results of this study also provide information to help interpret results after treatment.

Acceptance and commitment therapy for chronic pain: protocol of a systematic review and individual participant data meta-analysis

BackgroundAcceptance and commitment therapy (ACT) can be effective in treating chronic pain. Despite evidence supporting the effectiveness of ACT, uncertainties remain regarding which subgroups in the chronic pain population are likely to benefit most and least. This protocol describes the application for two meta-analytic approaches, one at the level of individual participant data and the other at the level of aggregated data, from randomized controlled trials of ACT for chronic pain (ACT-CP-MA).MethodsWe will systematically conduct literature searches in CENTRAL, MEDLINE, EMBASE, PsycINFO, and trial registers. Two reviewers will independently select studies for inclusion and data extraction. ACT-CP-MA will include randomized controlled trials with ACT for chronic pain compared to control conditions for adults (≥ 18 years) with chronic pain (> 3 months). We will invite the authors of all eligible trials to share individual participant data. Outcomes will include standardized measures of pain interference, pain intensity, depression, anxiety, health-related quality of life, participants’ rating of overall improvement, and ACT-related process variables. Using the Cochrane Collaboration’s tool and GRADE, reviewers will independently check for risk of bias, quality of evidence, and strength of recommendations. In the individual participant data meta-analysis, we will use a one-step approach where participants are clustered with studies and data from all studies are modeled simultaneously. For analyses, we will use mixed-effects models. Additionally, we will employ a meta-analysis with aggregate data and compare the results of both meta-analyses.DiscussionThis collaborative meta-analysis of individual participant data from randomized controlled trials of ACT for chronic pain versus control conditions will demonstrate how the known benefits of ACT for chronic pain vary across different subtypes of the chronic pain population. The results of the meta-analyses will be based on a comprehensive search of multiple databases and will help to inform future clinical trials and decision-making on the use of ACT in chronic pain and improve the quality, design, and reporting of future trials in this field.Systematic review registrationPROSPERO CRD42019120901.

PF731 A STRATEGY FOR THE MEASUREMENT OF SICKLE CELL DISEASE SYMPTOMS FROM THE PATIENT PERSPECTIVE

Please indicate where the abstract has been published before: Blood 2018Background:Sickle cell disease (SCD), an inherited blood disorder, impacts multiple organs leading to variable clinical presentation. In addition to severe pain episodes, patients may experience chronic symptoms (eg, pain, tiredness). Assessing treatment benefit using a patient‐reported outcome (PRO) measurement strategy is important in SCD research.Aims:To understand the SCD patient experience and inform the selection or development of fit‐for‐purpose PRO instrument(s) to assess daily chronic symptoms in clinical trials for adolescents and adults with SCD ≥16 years.Methods:A literature review and interviews with clinical experts (N = 5) and adolescents and adults with SCD (N = 20) were conducted to develop an SCD conceptual model summarizing important SCD signs, symptoms, and impacts. An instrument review identified and assessed the existing PRO measures used in SCD research and documented their development history and measurement properties. Concepts in the SCD conceptual model were compared to those assessed in reviewed PRO measures. Considerations for concept selection (eg, suitability of measuring symptoms via PRO measure) and item construction (eg, selection of recall period) in developing PRO measurement strategies were summarized.Results:Patients reported 22 symptoms that they experienced regularly and/or during pain crises, which were largely endorsed by the literature and/or clinical experts. Pain was reported by all patients, and tiredness was reported by 80%; both were reported as the most important to improve with treatment. Patients reported impacts of SCD on their daily lives across 9 domains (activities of daily living, cognitive, emotional, financial, leisure, physical, sleep, social, and work/school impacts).Five PRO measures used in SCD research were reviewed: The Adult Sickle Cell Quality of Life Measurement Information System (ASCQ‐MeSM), Pediatric Quality of Life Inventory (PedsQL™) sickle cell disease module, the Patient‐Reported Outcomes Measurement Information System (PROMIS) Fatigue and Pediatric Pain Interference measures, and Scribe Sickle Cell Record of Daily Symptom Burden™ (SSCRDSB). None of the measures assessed &gt;5 of the symptoms included in the SCD conceptual model, with the SSCRDSB assessing the greatest number (5/22 concepts). Pain was the most frequently measured concept (assessed by 3/5 PRO measures). The most frequently measured impact domain was physical impacts, assessed to varying degrees by all 5 measures. The PedsQL™ SCD module assessed the greatest number of impact domains in the SCD conceptual model (7/9 domains). The reviewed measures were determined to have limitations (eg, inadequate concept coverage and recall period) in assessing SCD symptoms daily as part of regulated clinical trials.Summary/Conclusion:These results suggest that 1) patients experience several SCD symptoms regularly and intermittently, 2) existing instruments, while perhaps suitable for other contexts of use or in conjunction with other tools, may be inadequate for evaluating important SCD symptoms in a way that can demonstrate treatment benefit when measured daily in regulated clinical research. Instruments developed for this purpose should have documented evidence of content validity (ie, relevant instrument measures and understandable concepts) and should include clear instructions, a short recall period, items that measure dimensions of importance to patients (eg, symptom intensity), and well‐defined response options that are sufficiently sensitive to detect change.

Feasibility of a Hybrid Web-Based and In-Person Self-management Intervention Aimed at Preventing Acute to Chronic Pain Transition After Major Lower Extremity Trauma (iPACT-E-Trauma): A Pilot Randomized Controlled Trial.

Objective 1) To assess the feasibility of research methods to test a self-management intervention aimed at preventing acute to chronic pain transition in patients with major lower extremity trauma (iPACT-E-Trauma) and 2) to evaluate its potential effects at three and six months postinjury. Design A pilot randomized controlled trial (RCT) with two parallel groups. Setting A supraregional level 1 trauma center. Methods Fifty-six adult patients were randomized. Participants received the intervention or an educational pamphlet. Several parameters were evaluated to determine the feasibility of the research methods. The potential efficacy of iPACT-E-Trauma was evaluated with measures of pain intensity and pain interference with activities. Results More than 80% of eligible patients agreed to participate, and an attrition rate of ≤18% was found. Less than 40% of screened patients were eligible, and obtaining baseline data took 48 hours postadmission on average. Mean scores of mild pain intensity and pain interference with daily activities (<4/10) on average were obtained in both groups at three and six months postinjury. Between 20% and 30% of participants reported moderate to high mean scores (≥4/10) on these outcomes at the two follow-up time measures. The experimental group perceived greater considerable improvement in pain (60% in the experimental group vs 46% in the control group) at three months postinjury. Low mean scores of pain catastrophizing (Pain Catastrophizing Scale score < 30) and anxiety and depression (Hospital Anxiety and Depression Scale scores ≤ 10) were obtained through the end of the study. Conclusions Some challenges that need to be addressed in a future RCT include the small proportion of screened patients who were eligible and the selection of appropriate tools to measure the development of chronic pain. Studies will need to be conducted with patients presenting more serious injuries and psychological vulnerability or using a stepped screening approach.

Japanese cross-cultural validation study of the Pain Stage of Change Questionnaire.

Introduction:Although evidence supports efficacy of treatments that enhance self-management of chronic pain, the efficacy of these treatments has been hypothesized to be influenced by patient readiness for self-management. The Pain Stage of Change Questionnaire (PSOCQ) is a reliable and valid measure of patient readiness to self-manage pain. However, there is not yet a Japanese version of the PSOCQ (PSOCQ-J), which limits our ability to evaluate the role of readiness for pain self-management in function and treatment response in Japanese patients with chronic pain.Objective:Here, we sought to develop the PSOCQ-J and evaluate its psychometric properties.Methods:We recruited 201 patients with chronic pain. The study participants were asked to complete the PSOCQ-J and other measures assessing pain severity, pain interference, catastrophizing, self-efficacy, and pain coping strategies.Results:The results supported a 4-factor structure of the PSOCQ-J. We also found good to excellent internal consistencies and good test–retest reliabilities for the 4 scales. The Precontemplation scale had weak to moderate positive correlations with measures of pain-related dysfunction and maladaptive coping. The Action and Maintenance scales had weak to moderate positive correlations with measures of self-efficacy and adaptive coping. The Contemplation scale had weak positive correlations with measures of pain interference and both adaptive and maladaptive coping.Conclusions:The PSOCQ-J demonstrated adequate psychometric properties in a sample of Japanese patients with chronic pain. This measure can be used to evaluate the role that readiness to self-manage pain may play in adjustment to chronic pain in Japanese pain populations.

A parallel randomized controlled trial examining the effects of rhythmic sensory stimulation on fibromyalgia symptoms.

This double-blind, two-arm parallel randomized controlled trial investigated the effects of gamma-frequency rhythmic sensory stimulation on fibromyalgia. We were interested in whether rhythmic sensory stimulation would promote significant changes in fibromyalgia and associated symptoms, and whether treatment effects would differ between two distinct treatment parameters. Fifty patients with a formal diagnosis of fibromyalgia were randomly assigned to two test groups. One group received vibrotactile stimulation from a continuous sine wave single-frequency stimulation (40 Hz) for 30 minutes, five days per week, over five weeks, concomitant with usual care. The second group completed the same treatment protocol but received a different stimulation, consisting of random and intermittent complex wave gamma-range vibrotactile stimulation. Fibromyalgia symptoms, pain severity and interference, depression symptoms, quality of life and sleep quality were assessed at baseline and post-intervention. Results indicated that there were statistically significant changes from baseline to post-treatment in measures of fibromyalgia symptom severity, pain interference, depression, and sleep quality. However, treatment outcomes did not differ significantly between groups. These findings provide preliminary evidence that gamma-frequency rhythmic vibroacoustic stimulation may decrease fibromyalgia symptoms and ease associated comorbidities, opening new avenues for further investigation of the effects of rhythmic sensory stimulation on chronic pain conditions.

Clinical Meaning of Promis Pain Interference and Pain Behavior Measures for Children with Sickle Cell Disease

Introduction: The Patient Reported Outcomes Measurement Information System (PROMIS) includes tools to assess pain interference and pain behavior for pediatric patients. These domains are especially relevant for children with sickle cell disease who have recurring pain. Though these domains have been shown to be reliable and valid in this patient population, their adoption in practice is significantly limited by lack of clinical interpretation of the scores. The objective of this study was to add clinical meaning to the self-reported pain inference and pain behavior scores for children with sickle cell disease.Methods: We recruited a convenience sample of children with sickle cell disease, 8-17 years of age at Children's Hospital of Wisconsin to complete PROMIS surveys. The pediatric PROMIS measures are scored on a T-score metric with a mean of 50 and standard deviation of 10, where 50 represents the mean of the pediatric sample in which the item response theory parameters for the measures were estimated. The PROMIS measures for pain interference and pain behavior use a Likert response scale and have a one week recall period. The Likert scale responses were characterized into three groups to support clinical interpretation of PROMIS scores. Patients who reported “never” or “almost never” for all items on the pain interference domain were considered to be having “no or minor pain”. Patients who reported “often” or “almost always” for all items were considered to be having “substantial” pain. All other patients were classified as having “mixed” pain interference. Similarly, in the pain behavior domain, patients were categorized as having ‘no or minor’ (response to all items: “had no pain”, “never”, “almost never”), or ‘substantial’ (response to all items: “often” and “almost always”) pain behavior, with remaining considered as having mixed pain behavior. For the domains of pain interference and pain behavior, higher scores mean more impairment. The range of scores for patients with no or minor, mixed and substantial problems on the measures were used to determine the clinical thresholds to identify those with mild, moderate and severe symptoms. The thresholds were validated by comparing the distribution of patients who needed to take pain medications in the past 7 days among the groups of patients with mild, moderate and severe symptoms, using Chi-square tests and adjusting for multiple pairwise comparisons.Results: Our study included 115 eligible children (mean (sd) age = 11.8 (2.8) years), of which 54% were females and 95% were African Americans. For pain interference, there were 36 patients reporting no or minor issues, 16 had substantial issues and the remaining 62 were considered to have mixed pain interference (T-score was missing for one patient). Based on the T-score ranges of these groups, the clinical thresholds of mild and severe pain interference were set to be ≤ 48.3 and ≥ 63.6 respectively. For the domain of pain behavior, 30 children reported having no or minor problems, 6 had substantial problems and the remaining 79 endorsed mixed responses on the items. The range-based thresholds for mild and severe pain behavior were similar at ≤ 41.3 and ≥ 57.3 respectively. Figure 1 shows an example of the distribution of item-level response for one item within the severity groups. There were significant differences in the proportion of patients needing to take pain medications at home in the prior 7 days among those with mild, moderate and severe pain interference (% patients needing pain medications, Mild= 7%; Moderate = 28%; Severe = 44%; p = 0.0095) and pain behavior (% patients needing pain medications, Mild= 6%; Moderate = 32%; Severe = 30%; p = 0.0013). The pairwise comparisons indicate that there were significant differences in proportion of patients needing pain medications between the mild and the moderate/severe groups. However, there were no significant differences in pain medication use between the moderate and severe patients.Conclusions: We show that T-scores ≤ 48.3 and ≤ 41.3 on the respective pain interference and pain behavior domains serve as thresholds for children with no or only mild pain. Whereas children with severe pain have T-scores ≥ 63.6 and ≥ 57.3 on pain interference and pain behavior domains respectively. This facilitates the clinical interpretation of PROMIS pain interference and pain behavior scores for children with sickle cell disease. [Display omitted] DisclosuresPanepinto:National Institute of Arthritis and Musculoskeletal and Skin Diseases: Research Funding; Health Resources and Services Administration: Research Funding.