Chronic, postsurgical pain (CPSP) is defined as pain that arises after a surgical procedure and that lasts at least 2 months and cannot be attributed to an alternative cause. Epidemiologic studies estimate that between 10% and 30% of patients undergoing surgery report persistent pain 1 year postoperatively. The etiology of CPSP does not have a clearly established or widely accepted pathophysiological cause, and diagnostic workups are often costly and fail to identify an identifiable etiology. CPSP may be treated with analgesics as the first-line therapy; however there are no well-established guidelines on management. In refractory cases, medications targeting neuropathic pain, further surgical evaluation, and acupuncture techniques can be considered.

Background Patient-Reported Outcomes Measurement Information System (PROMIS) measures are used increasingly in clinical care. However, for juvenile idiopathic arthritis (JIA), scores lack a framework for interpretation of clinical severity, and minimally important differences (MID) have not been established, which are necessary to evaluate the importance of change. Methods We identified clinical severity thresholds for pediatric PROMIS measures of mobility, upper extremity function (UE), fatigue, and pain interference working with adolescents with JIA, parents of JIA patients, and clinicians, using a standard setting methodology modified from educational testing. Item parameters were used to develop clinical vignettes across a range of symptom severity. Vignettes were ordered by severity, and panelists identified adjacent vignettes considered to represent upper and lower boundaries separating category cut-points (i.e., from none/mild problems to moderate/severe). To define MIDs, panelists reviewed a full score report for the vignettes and indicated which items would need to change and by how much to represent “just enough improvement to make a difference.” Results For fatigue and UE, cut-points among panels were within 0.5 SD of each other. For mobility and pain interference, cut-scores among panels were more divergent, with parents setting the lowest cut-scores for increasing severity. The size of MIDs varied by stakeholders (parents estimated largest, followed by patients, then clinicians). MIDs also varied by severity classification of the symptom. Conclusions We estimated clinically relevant severity cut-points and MIDs for PROMIS measures for JIA from the perspectives of multiple stakeholders and found notable differences in perspectives.

Abstract The Patient-Reported Outcomes Measurement Information System (PROMIS) initiative is a comprehensive strategy by the National Institutes of Health to support the development and validation of precise instruments to assess self-reported health domains across healthy and disease-specific populations. Much progress has been made in instrument development, but there remains a gap in the validation of PROMIS measures for pediatric chronic pain. The purpose of this study was to investigate the construct validity and responsiveness to change of 7 PROMIS domains for the assessment of children (ages: 8-18) with chronic pain—Pain Interference, Fatigue, Anxiety, Depression, Mobility, Upper Extremity Function, and Peer Relationships. The PROMIS measures were administered at the initial visit and 2 follow-up visits at an outpatient chronic pain clinic (CPC; N = 82) and at an intensive amplified musculoskeletal pain day-treatment program (N = 63). Aim 1 examined construct validity of PROMIS measures by comparing them with corresponding “legacy” measures administered as part of usual care in the CPC sample. Aim 2 examined sensitivity to change in both CPC and amplified musculoskeletal pain samples. Longitudinal growth models showed that PROMIS' Pain Interference, Anxiety, Depression, Mobility, Upper Extremity, and Peer Relationship measures and legacy instruments generally performed similarly with slightly steeper slopes of improvement in legacy measures. All 7 PROMIS domains showed responsiveness to change. Results offered initial support for the validity of PROMIS measures in pediatric chronic pain. Further validation with larger and more diverse pediatric pain samples and additional legacy measures would broaden the scope of use of PROMIS in clinical research.

As initial steps in a broader effort to develop and test pediatric pain behavior and pain quality item banks for the Patient-Reported Outcomes Measurement Information System (PROMIS), we used qualitative interview and item review methods to 1) evaluate the overall conceptual scope and content validity of the PROMIS pain domain framework among children with chronic/recurrent pain conditions, and 2) develop item candidates for further psychometric testing. To elicit the experiential and conceptual scope of pain outcomes across a variety of pediatric recurrent/chronic pain conditions, we conducted 32 semi-structured individual and 2 focus-group interviews with children and adolescents (8-17 years), and 32 individual and 2 focus-group interviews with parents of children with pain. Interviews with pain experts (10) explored the operational limits of pain measurement in children. For item bank development, we identified existing items from measures in the literature, grouped them by concept, removed redundancies, and modified the remaining items to match PROMIS formatting. New items were written as needed and cognitive debriefing was completed with the children and their parents, resulting in 98 pain behavior (47 self, 51 proxy), 54 quality, and 4 intensity items for further testing. Qualitative content analyses suggest that reportable pain outcomes that matter to children with pain are captured within and consistent with the pain domain framework in PROMIS.Perspective: PROMIS pediatric pain behavior, quality, and intensity items were developed based on a theoretical framework of pain that was evaluated by multiple stakeholders in the measurement of pediatric pain, including researchers, clinicians, and children with pain and their parents, and the appropriateness of the framework was verified. (C) 2015 by the American Pain Society

The NIH Patient Reported Outcomes Measurement Information System (PROMIS) has created publicly available patient reported outcomes measures in several domains of physical, social and emotional health. Measurement of pediatric pain in PROMIS is currently limited to pain interference. Pain behaviors are observable actions orreactions that communicate pain including verbal, nonverbal and pain reducing behaviors. Numerous validated parent/provider-rating scales of pain behavior in children exist but there are currently no validated self-report measures of pain behavior in school-age children and adolescents. Such measures could be useful in establishing targets for treatment and assessing outcomes. The aim of this study is to enhance PROMIS pediatric pain assessment by developing and testing pediatric pain behavior item banks for self- and proxy-report. Candidate items were developed through a qualitative item review process, and were in the format, “In the past 7 days, when I was in pain …” Patients ages 8 to 17 years, or parents/guardians of children, with a chronic painful condition (fibromyalgia, juvenile idiopathic arthritis, sickle cell disease) were recruited through outpatient clinics at 3 centers. Child participants completed approximately 100 PROMIS items concerning their pain (including 47 candidate pain behavior items), physical function, fatigue, and psychosocial well/being. Proxies responded to sociodemographic and health history items and 51 new candidate proxy-report pain behavior items were collected. A confirmatory factor analysis (CFA) was performed on the child and guardian pain behavior data, with model fit assessed by the comparative fit index (CFI) and root mean square error of approximation (RMSEA). Item response theory (IRT) analysis was performed on the pain behavior items based on the graded response model. Differential item functioning (DIF) was assessed by age group and disease group. 450 children (71% female, Mage 13.54), and 232 proxies participated. CFA indicated unidimensionality in the child (CFI = 0.962; RMSEA = 0.079) and proxy pain behavior responses (CFI = 0.970; RMSEA = 0.080). The responses for the child and proxy data had good IRT model fit and were free of local dependence. Slopes for the pediatric responses ranged from 1.81 (“rubbed body where hurt”) to 4.40 (“moved slower”), and thresholds ranged from −2.00 to 4.95. For the proxy data, slopes ranged from 1.51 (“think of something fun”) to 3.48 (“tried not to move”), and thresholds ranged from −3.02 to 2.43. Items performed well across disease groups and age. There was little DIF either by age group (8–12, 13–18) or by sample (child vs. proxy). Child and proxy scores were correlated at 0.70. Correlations between pain behavior and pain intensity were 0.60 in children and 0.65 in proxy sample. The PROMIS pediatric pain behavior item-banks for self and proxy report are suitable for use in non-adaptive format as short forms or in dynamic format as computerized adaptive tests in clinical research with the potential for adoption into clinical care.

Objectives To examine the content validity of the Patient-Reported Outcomes Measurement Information System pediatric measures, including the pain interference scale, among children and adolescents (aged 8-18 years) who experience chronic pain. To describe children's understandings of the health domain constructs and elucidate verbal and conceptual aspects of self-reported pain-related functioning, which shape disclosure and reporting. Methods 34 children and youth with diagnoses of juvenile idiopathic arthritis or noninflammatory chronic pain completed semistructured and cognitive interviews exploring the meaning, experience, and expression of up to 4 of the Patient-Reported Outcomes Measurement Information System pediatric domains: anger, anxiety, depressive symptoms, fatigue, pain interference, and peer relationships. Team-based thematic and content analyses were conducted. Results Clear verbal and social-cognitive differences were observed in representations and accounts of the domain-experiences across age-groups, but we noted little, if any, evidence of problems with content validity. Conclusions Findings suggest the importance of a rigorous developmental approach for understanding the verbal and cognitive dimensions of pediatric self-reports and patient-reported outcomes.

Understanding the language youth use to describe their pain experience is essential to developing relevant and meaningful measures of pediatric pain quality and pain behavior for research or clinical care. The primary objective of this study was to elicit feedback from children and adolescents on candidate items developed for inclusion in the Patient Reported Outcomes Measurement Information System (PROMIS®). Cognitive interviews were conducted with youth ages 8-18 with chronic painful conditions to assess linguistic and conceptual understanding of items, as well as relevance and resonance to patient experience. Fifteen parents reviewed proxy items to measure pain behavior. Experts in pain research and assessment provided external review. Fifteen participants (mean=13.9 years) were interviewed on a total of 126 items (pain behavior=51 items; pain quality=71 items; pain intensity/global pain=4 items). Each item was reviewed by at least five participants. All participants demonstrated the ability to communicate which items they found confusing or difficult to understand, with older children more adept at articulation. Items found difficult to comprehend were deleted from the item bank (n=28), or revised for clarification (n=11). Ten pain behavior items were dropped because items did not resonate or it was unclear how the behavior related to pain. Eight pain quality items were dropped due to difficulty understanding word meanings. When appropriate, new items suggested by participants or pain experts were added (n=14). Parents differed from children in endorsement of relevant pain behavior items. While children tended to deny anger as a result of pain, parents were more inclined to report these behaviors. Children in this study were able to discuss their experience with pain. This study highlights the importance of obtaining children's input, as developmental, cognitive, and linguistic factors influence children's interpretation of items. Supported: PROMIS and NIH (1U01AR057940).