Pain Intensity Items Research Articles

The PROMIS-16 reproduces the PROMIS-29 physical and mental health summary scores accurately in a probability-based internet panel.

The Patient-Reported Outcomes Measurement Information System® (PROMIS)-16 assesses the same multi-item domains but does not include the pain intensity item in the PROMIS-29. We evaluate how well physical and mental health summary scores estimated from the PROMIS-16 reproduce those estimated using the PROMIS-29. An evaluation of data collected from 4130 respondents from the KnowledgePanel. Analyses include confirmatory factor analysis to assess physical and mental health latent variables based on PROMIS-16 scores, reliability estimates for the PROMIS measures, mean differences and correlations of scores estimated by the PROMIS-16 with those estimated by the PROMIS-29, and associations between differences in corresponding PROMIS-16 and PROMIS-29 scores by sociodemographic characteristics. A two-factor (physical and mental health) model adequately fits the PROMIS-16 scores. Reliability estimates for the PROMIS-16 measures were slightly lower than for the PROMIS-29 measures. There were minimal differences between PROMIS physical and mental health summary scores estimated using the PROMIS-16 or the PROMIS-29. PROMIS-16 and PROMIS-29 score differences by sociodemographic characteristics were small. Using the PROMIS pain intensity item when scoring the PROMIS-16 produced similar estimates of physical and mental health summary scores. The PROMIS-16 provides similar estimates of the PROMIS-29 physical and mental health summary scores. The high reliability of these scores indicates they are accurate enough for use with individual patients.

Comparison of pain intensity measurements among patients with low-back pain

<p>Pain intensity is the most frequently assessed health domain in clinical studies among patients with low-back pain. Visual analogue scale (VAS) and Numeric rating scale (NRS) have been the mostly used measurement tools for pain intensity. We proposed to correlate these instruments to a generic health-related quality of life measurement tool in order to show the scale with superior clinical relevance.</p>. <p>We used cross-sectional, convenience sampling. 120 patients with chronic low-back pain administered the 29-item Patient Reported Outcomes Measurement Information System Profile with NRS included, and the VAS scale in the National Institute of Mental Health, Neurology and Neurosurgery. We determined the correlation between PROMIS domain T-scores and VAS and NRS scores.</p>. <p>We performed Spearman rank correlation test to calculate the correlation coefficient. We found VAS scales measuring pain had weak to moderate correlations with all PROMIS health domains (r = 0.24&ndash;0.55). Therefore, we compared correlation of PROMIS domain scores with PROMIS pain intensity numeric rating scale and VAS scales. PROMIS domains had moderate to strong correlations with pain intensity scale (r = 0.45&ndash;0.71). PROMIS physical function short form [r = &ndash;0.65, 95% CI (&ndash;0.75) &ndash; (&ndash;0.55)] and PROMIS pain interference short form (r = 0.71, 95% CI 0.63 &ndash; 0.79) had the strongest correlation with pain intensity item.</p>. <p>NRS has showed greater correlation with PROMIS domain T-scores than VAS scale. This may prove that NRS has greater connection to another health domains, thus it correlated more to health-related quality of life than visual scale. We recommend NRS to use in further clinical studies conducted among patients with low-back pain.</p>.

Estimating individual health-related quality of life changes in low back pain patients

BackgroundThere is a need to evaluate different options for estimating individual change in health-related quality of life for patients with low back pain.MethodsSecondary analysis of data collected at baseline and 6 weeks later in a randomized trial of 749 adults with low back pain receiving usual medical care (UMC) or UMC plus chiropractic care at a small hospital at a military training site or two large military medical centers. The mean age was 31; 76% were male and 67% were White. The study participants completed the Patient-Reported Outcomes Measurement Information System (PROMIS®)-29 v 1.0 physical function, pain interference, pain intensity, fatigue, sleep disturbance, depression, anxiety, satisfaction with participation in social roles, physical summary, and mental health summary scores (T-scored with mean = 50 and standard deviation (SD) = 10 in the U.S. general population).ResultsReliability estimates at the baseline ranged from 0.700 to 0.969. Six-week test–retest intraclass correlation estimates were substantially lower than these estimates: the median test–retest intraclass correlation for the two-way mixed-effects model was 0. 532. Restricting the test–retest reliability estimates to the subset who reported they were about the same as at baseline on a retrospective rating of change item increased the median test–retest reliability to 0.686. The amount of individual change that was statistically significant varied by how reliability was estimated, and which SD was used. The smallest change needed was found when internal consistency reliability and the SD at baseline were used. When these values were used, the amount of change needed to be statistically significant (p < .05) at the individual level ranged from 3.33 (mental health summary scale) to 12.30 (pain intensity item) T-score points.ConclusionsWe recommend that in research studies estimates of the magnitude of individual change needed for statistical significance be provided for multiple reliability and standard deviation estimates. Whenever possible, patients should be classified based on whether they 1) improved significantly and perceived they got better, 2) improved significantly but did not perceive they were better, 3) did not improve significantly but felt they got better, or 4) did not improve significantly or report getting better.

The Use and Perceptions of the Defense and Veterans Pain Rating Scale by Nursing Personnel

BackgroundIn 2010, the Office of the US Army Surgeon General recommended the Veterans Administration (VA) assess pain using the Defense and Veterans Pain Rating Scale (DVPRS). One item in the DVPRS is for measuring pain intensity. This item contains a combination of five response metrics: categories, faces, colors, numbers, and functional descriptors. A few studies have supported patients’ and health care providers’ preferences for the DVPRS and its psychometric properties. However, they also left uncertainties about its usability and validity. AimsTo advance our understanding of the DVPRS, this study examined the use and perceptions of the DVPRS’ pain intensity item by nursing personnel during multi-modal care. DesignA cross-sectional survey design was used. SettingVA Community Living Center. ParticipantsNursing personnel. MethodsNursing personnel answered closed- and open-ended survey questions during a single session. ResultsNursing personnel reported sufficient training before implementing the measure and that patients primarily used the numeric metric. When patients used a non-numeric metric, the nursing personnel responded in variable ways. In addition, the nursing personnel interpreted the functional descriptors differently. The nursing personnel also noted the need to supplement the pain intensity item with patients’ pain duration and pain location. ConclusionsResults from this study inform the nursing community about the DVPRS’ pain intensity item, which combines multiple response metrics. The results support the need for nursing units to generate and standardize procedures for using the item to measure multi-site pain and for interpreting and documenting patients’ non-numeric responses. The effects of such procedures on the measure's usability and psychometric properties warrants additional investigation.

Pain and health-related quality of life in Duchenne muscular dystrophy: A multiple mediator analysis.

The objective was to investigate the serial mediating effects of daily activities, patient health communication, and disease-specific worry in the relationship between pain intensity and overall generic health-related quality of life (HRQOL) in pediatric patients with Duchenne muscular dystrophy from the patient perspective. Pain Intensity Item, Daily Activities Scale, Communication Scale and Worry Scale from Pediatric Quality of Life Inventory (PedsQL) Duchenne Muscular Dystrophy Module and PedsQL 4.0 Generic Core Scales were completed by 110 pediatric patients with Duchenne muscular dystrophy ages 8-17. A serial multiple mediator model analysis was conducted to test the hypothesized sequential mediating effects of daily activities, patient health communication, disease-specific worry as intervening variables in the association between the pain intensity predictor variable and overall generic HRQOL. Pain predictive effects on overall generic HRQOL were serially mediated by daily activities, patient health communication, and disease-specific worry. In a predictive analytics model utilizing hierarchical multiple regression analysis with age demographic covariate, patient-reported pain intensity, daily activities, patient health communication, and disease-specific worry accounted for 47% of the variance in overall generic HRQOL (P<0.001), representing a large effect size. Pain intensity, daily activities, patient health communication, and disease-specific worry explain in part the mechanism of pain predictive effects on overall generic HRQOL in pediatric patients with Duchenne muscular dystrophy. Identifying the mediators of pain intensity on overall generic HRQOL from the patient perspective may inform targeted clinical interventions and future patient-centered clinical research to improve overall daily functioning.

Feasibility of Patient-Reported Outcome Assessment in the Acute Phase after CAR T-Cell Therapy in Lymphoid Malignancies: A Pilot Study

Introduction: Although acute toxicities of chimeric antigen receptor T-cell (CAR T-cell) therapies are well described, there is a paucity of data on patient-reported outcomes (PROs) in the acute phase after CAR T-cell infusion. We performed a prospective pilot study to assess the feasibility of measuring PROs and trajectory of health-related quality of life (HRQoL) in the first 3 months after CAR T-cell therapy in lymphoid malignancies. Methods: We enrolled patients with aggressive B-cell non-Hodgkin lymphoma receiving CD-19 directed CAR T-cell therapy. PROs were assessed using 2 instruments: PROMIS-29 v2.0 (7 domains and 29 items) and FACT-Lym (6 domains and 48 items). PROs were assessed at the following time-points: baseline/prior to lymphodepleting chemotherapy, day#0 (day of CAR T-cell infusion [before infusion]), and post-CAR days 7 (±3), 14 (±3), 21 (±3), 28 (±3), 60 (±10), and 90 (±10). The primary endpoint was compliance rate of PRO instruments at each time-point. The key secondary endpoint was trajectory of QoL domains, as measured by PROMIS-29 and FACT-Lym. The raw score of each PROMIS-29 domain was converted to standardized T-score, which has a mean of 50 (±10) for general US population and a minimal clinically important difference (MCID) of 5 . Results: A total of 23 patients were enrolled, among which 3 died prior to baseline PRO assessment. In 20 evaluable patients, median age was 66 years (range, 50-78) and all had ECOG performance status 0 or 1. The CAR T product was tisa-cel in 11, axi-cel in 9, and experimental in 1 patient. Two patients died during the study period, one at day#35 and one at day#89 after CAR T-cell infusion. Proportion of patients with any missing PROMIS data increased from 0% at baseline to the highest of 50% at day#14 post CAR (p-value for trend=0.0001), and subsequently decreased to 22% at day 90 (p-value for trend [day#14 vs 90]=0.01) (Figure 1a). Proportion of patients with any missing FACT-Lym increased from 15% at baseline to the highest of 50% at day#14/21, and then decreased to 22.2% at day#90. The three domains of PROMIS-29 that showed significant change over time were physical function, fatigue, and satisfaction with social role (Figure 1b). The physical function T-score (46.5 [baseline]-->38.8 [day#21]-->43.6 [day#90]) and satisfaction with social role T-score (50.2 [baseline]-->43.0 [day#21]-->49.3 [day#90]) significantly decreased from baseline to day#21, and then significantly increased from day#21 to day#90, with fatigue T-score showing a significant increase-decrease pattern (50.6-->55.9-->49.1, at respective time-points). There were no significant difference between baseline and post-CAR day#90 for all three scores. There was also no significant change in pain over time, both by PROMIS pain interference domain and pain intensity item. The only FACT-Lym domain that showed significant change over time was Functional Well-Being (FWB). It decreased from baseline to day#21 (LS-mean 0.37 to 0.30, p=0.04 , and significantly increased from day#21 to day#90 (0.30 to 0.38, p=0.03). Conclusion: Our study adds novel data on feasibility of using PROMIS-29 for PRO assessment in CAR T-cell therapy recipients. The rate of missing data with both PROMIS-29 and FACT-Lym was greatest at day#14 and day#21 post-CAR, which correlated with a drop in HRQoL. Notably, PROMIS-29 demonstrated significant variability in PROs in the domains of physical function, fatigue, and satisfaction with social roles, whereas only one FACT-Lym domain (functional wellbeing) showed significant variability. Future clinical trials of CAR T-cell therapy should incorporate CMS-recommended PROMIS-29 for PRO assessment to reduce heterogeneity and enable comparison across products and trials. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

122 PTSD Symptom Clusters as Predictors of Pain Interference in Burn Survivors

IntroductionIndividuals who experience burns are at higher risk of developing post-traumatic stress disorder (PTSD) and chronic pain. There exists a synergistic relationship between PTSD and chronic pain in burn survivors. Theories exist about how aspects of each condition may perpetuate one another, or share underlying mechanisms. Both of these conditions are of relevance to pain-related disability. We sought to examine the role of individual PTSD symptom clusters as predictors of pain interference. We hypothesized that the hyperarousal and emotional numbing symptom clusters would be predictive of pain interference, even when accounting for the other two PTSD symptom clusters, pain intensity, and other covariates (burn size, hospital length of stay, age and gender).MethodsData were analyzed from the Burn Model System National Database. Inclusion criteria required participants to have a moderate to severe burn injury that required surgery for wound closure. Patient-reported outcome data: PTSD Checklist - Civilian, PROMIS-Pain Interference Short Form 4a, and a 0-10 average Pain Intensity item were analyzed at 6-months after injury. Hierarchical linear regression models were fit to examine the impact of PTSD symptom clusters on pain interference over and above that of pain intensity, and standardized betas were calculated (B).ResultsA total of 439 adult participants had complete responses on the measures of interest (e.g. PTSD symptoms, PROMIS-Pain Interference, and Pain Intensity) and were included in the analysis. Mean age, percent total body surface area burned, and hospital length of stay were 47 years, 18%, and 27 days, respectively. 69% were male and 82% were Caucasian. Results of a linear regression found that hyperarousal (B = .10, p = .03) and emotional numbing (B = .13, p = .01) PTSD symptom clusters were each significant predictors of pain-related disability, even when accounting for pain intensity (B = .64, p < .001). The covariates age, gender, days until discharge, and TBSA were all nonsignificant. The model accounted for 61% of the variance associated with pain-related disability.ConclusionsResults highlight the importance of the emotional numbing and hyperarousal PTSD symptom clusters in explaining pain interference. Future evaluations parsing out the longitudinal relationships (i.e., beyond 6-months postburn) between PTSD symptom clusters, pain intensity, and pain interference, as well as evaluating other underlying mechanisms, are warranted.

PSMAfore: A phase 3 study to compare 177Lu-PSMA-617 treatment with a change in androgen receptor pathway inhibitor in taxane-naïve patients with metastatic castration-resistant prostate cancer.

TPS211 Background: [177Lu]Lu-PSMA-617 (177Lu-PSMA-617) is a high-affinity prostate-specific membrane antigen (PSMA)-targeted radioligand therapy that delivers β-particle radiation to PSMA-expressing cells and their surrounding microenvironment. In the phase 3 VISION trial, 177Lu-PSMA-617 significantly prolonged radiographic progression-free survival (rPFS) and overall survival (OS) in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with ≥1 androgen receptor pathway inhibitor (ARPI) and 1–2 taxanes. PSMAfore is investigating the effect on rPFS in taxane-naïve patients with mCRPC treated with either 177Lu-PSMA-617 or a change in ARPI. Methods: PSMAfore (NCT04689828) is a multicenter, open-label, randomized phase 3 trial in adults with progressive mCRPC and confirmed PSMA expression by [68Ga]Ga-PSMA-11 PET/CT. Eligible patients are taxane-naïve in the metastatic setting and have: received one prior ARPI and are candidates for a change in ARPI; an Eastern Cooperative Oncology Group performance status of 0 or 1; a castrate level of serum/plasma testosterone ( &lt; 50 ng/dL or &lt; 1.7 nmol/L); and recovered to grade ≤2 from toxicities related to prior therapies. Approximately 450 patients will be randomized 1:1 to receive 177Lu-PSMA-617 (7.4 GBq i.v. every 6 weeks for 6 cycles) or a change in ARPI to either abiraterone or enzalutamide. Best supportive care is allowed in both arms. Stratification factors are prior ARPI use in castration-resistant vs hormone-sensitive prostate cancer settings and pain symptomatology (score 0–3 vs 4–10 on the worst pain intensity item of the Brief Pain Inventory–Short Form). The primary endpoint is rPFS according to PCWG3-modified RECIST v1.1 criteria. Participants with blinded independent centrally confirmed radiographic progression in the ARPI arm can crossover to the 177Lu-PSMA-617 arm. The planned sample size provides 95% power to detect a hazard ratio of 0.56 for rPFS after 156 events with an overall one-sided significance level of 0.025. The key secondary endpoint is OS; other secondary endpoints include safety and tolerability of 177Lu-PSMA-617 and health-related quality of life. Previously presented at the 2021 European Society for Medical Oncology Congress, FPN 942, Morris M et al. Reused with permission. Clinical trial information: NCT04689828.

Development and Psychometric Evaluation of the PROMIS Pediatric Pain Intensity Measure in Children and Adolescents with Chronic Pain

The goal of the current study was to enhance the measurement of the pediatric chronic pain experience through a methodologically rigorous approach. This paper outlines the development and initial validation of a pain intensity measure for pediatric patients with chronic pain using Patient-Reported Outcomes Measurement Information System methodology. Measure development incorporated feedback from children with painful conditions. Based on input from pediatric participants and content experts, 4 candidate items assessing pain intensity were included for large scale testing. Children completed self-report items pertaining to their pain experience that were developed as part of a larger pool of new candidate Patient-Reported Outcomes Measurement Information System pediatric pain domain items as well as measures of pain interference, depressive symptoms, fatigue, pain behavior, pain intensity, and pain catastrophizing. The final sample for the large scale testing included N = 442 pediatric patients between the ages 8 to 18 years (Mean age = 13.54, Standard Deviation = 2.78; 71.27% female) experiencing chronic pain. Psychometric analysis resulted in a final measure that included 3 items with evidence of reliability (Cronbach alpha = .82) and convergent validity. The Likert format of the response options may be preferable to the traditional numeric rating scale for use in pediatric populations who experience chronic pain based on patients’ feedback, which was directly utilized in designing the scale. Further, the inclusion of fewer and clinically meaningful response options should reduce ambiguity for young respondents. PerspectiveWe have developed and evaluated a clinically sensitive and psychometrically precise 3-item pain intensity measure with Likert-type responses for self-report use among children and adolescents ages 8 to 18 years with chronic pain. Development of the item content and response options included input from children and adolescents with chronic pain. The development of pain intensity items with pediatric appropriate language, and labeled, fewer response options to yield maximal clinically meaningful information improves the precision of pain intensity measurement in children.

Using PROMIS-29 to predict Neck Disability Index (NDI) scores using a national sample of cervical spine surgery patients

BACKGROUND CONTEXTPatient reported outcome measures (PROMs) are valuable tools for evaluating the success of spine surgery, with the Neck Disability Index (NDI) commonly used to assess pain-related disability. Recently, patient-reported outcomes measurement information system (PROMIS) has gained attention in its ability to measure PROs across general patient populations. However, PROMIS is not condition-specific so spine researchers are reluctant to incorporate it in place of common legacy measures. PURPOSETo compare the PROMIS-29 (v2.0) to the NDI and compute a conversion equation. STUDY DESIGNThis study retrospectively analyzes prospectively collected data from the cervical module of national spine registry, the Quality Outcomes Database (QOD). PATIENT SAMPLEThe QOD was queried for cervical spine surgery patients with PROMIS-29 and NDI scores. The cervical module of QOD includes patients undergoing primary or revision surgery for cervical degenerative spine diseases. Exclusion criteria included age under 18 years and diagnoses of infection, tumor, or trauma as the cause of cervical-related pain. OUTCOME MEASURESThe outcome of interest for this study was a conversion equation from PROMIS-29 to NDI. METHODSThe PROMIS-29 includes seven 4-item domains each rated on a 5-point scale: Physical function, depression, anxiety, fatigue, sleep disturbance, ability to participate in social roles and activities (social roles), and pain interference plus one stand-alone pain intensity item. The NDI contains 10 pain-related questions scored from 0 (no pain) to 5 (most severe pain).Outcomes were collected prior to surgery and at 3- and 12-month post surgery. Patients were included in the current analysis if they had outcome data available at one or more time points. Multivariable mixed effects regression models predicting NDI scores from PROMIS-29 domains were conducted in a development data set and validated in a separate data set. Predicted NDI scores were plotted against NDI scores to determine how well PROMIS-29 domains predicted NDI. Conversion equations were created from the PROMIS-29 regression coefficients. RESULTS2,018 patients from 18 US hospitals were included (mean age=57 years (SD=12)) with 48% female, 87% Caucasian, and 11% had revision surgery. Strong correlations were found between NDI and pain interference (r=0.79), pain intensity (r=0.74), social roles (r=−0.71), physical function (r=−0.69), sleep disturbance (r=0.63), fatigue (r=0.63), and anxiety (r=0.54). Correlation between NDI and depression (r=0.49) was slightly weaker. The pattern of correlations was consistent across timepoints. Four conversion equations were created for NDI using (1) only pain interference, (2) only physical function, (3) pain interference and physical function, and (4) the five statistically significant domains of pain interference, physical function, social roles, sleep disturbance, and anxiety, plus the pain intensity item. Equations 1, 3, and 4 were the best predictors of NDI, predicting approximately 80% of NDI scores within 15 points in the validation data set. Equation 4 (NDI%=18.897+0.855*[pain interferenceraw]–0.694*[physical functionraw]+2.010*[pain intensityraw]−0.663*[social rolesraw]+0.732*[sleep disturbanceraw]+0.426*[anxietyraw]) predicted NDI most accurately with an R2 between the predicted and actual NDI scores of 0.72. Model 1 (R2 = 0.62; NDI%=−4.055+3.164*[pain interferenceraw])) and Model 3 (R2=0.65; NDI%=17.321+2.543*[pain interferenceraw]–1.012*[physical functionraw]) also had good accuracy. CONCLUSIONSFindings suggest accurate NDI scores can be derived from PROMIS-29 domains. Clinicians who want to move from NDI to PROMIS-29 can use this equation to obtain estimated NDI scores when only collecting PROMIS-29. These results support the use of PROMIS-29 in cervical surgery populations and underscore the idea that PROMIS-29 domains have the potential to replace disease-specific traditional PROMs.

Frequency of Gastro-Esophageal Reflux symptoms in Healthy Children Determined by MM GERD Questionnaire in Mexico: An Exploratory Study

Background: GERD is a common disorder in children representing an important cause of consultation. Questionnaires have been proposed as a useful tool for primary care medicine but also as a cost effective option. However, it ’ s use still controversial in pediatric population. In this exploratory study, we have used the MM GERD Questionnaire in 2 elementary schools. Objective: An exploratory study to evaluate the MM GERD questionnaire in children of 5-17 years old of 2 elementary schools in Mexico City. Methods: A prospective, descriptive exploratory study including male and female children 5-17 years in which parents or tutors accept and sign ICF and willing to answer the 4 scale multi-dimensional GERD scale symptom (10 items), pain intensity scale (3 items); disability scale (3 items) and satisfaction scale (2 items). Results: A total of 223 children were included with 123 male and 99 female with mean age of 8.64 ± 2.7, weight 32.94 ± 14.17 kg, height 1.30 ± 0.17 mt and BMI of 18.67 ± 4.9. There was good construct validity among 4 scales measured with Pearson coefficient. The inter-item consistency (Cronbach’s co-efficient alpha) for the symptoms items, pain intensity items, disability items and satisfaction items were 0.41, 0.78, 0.87 and 0.4, respectively, demonstrating adequate reliability of the measure. Conclusion: MM GERD is a not a reliable questionnaire to explore the presence of upper gastrointestinal symptoms in healthy children from 5-17 years old. Thus several limitations, it is necessary to assess language, methodological and clinical validation of MM GERD to extrapolate these results into clinical practice.

Translation, cross-cultural and construct validity of the Dutch-Flemish PROMIS® upper extremity item bank v2.0.

To develop a Dutch-Flemish translation of the PROMIS® upper extremity (PROMIS-UE) item bank v2.0, and to investigate its cross-cultural and construct validity as well as its floor and ceiling effects in patients with musculoskeletal UE disorders. State of the art translation methodology was used to develop the Dutch-Flemish PROMIS-UE item bank v2.0. The item bank and four legacy instruments were administered to 205 Dutch patients with musculoskeletal UE disorders visiting an orthopedic outpatient clinic. The validity of cross-cultural comparisons between English and Dutch patients was evaluated by studying differential item functioning (DIF) for language (Dutch vs. English) with ordinal logistic regression models and McFadden's pseudo R2-change of ≥ 2% as critical value. Construct validity was assessed by formulating a priori hypotheses and calculating correlations with legacy instruments. Floor/ceiling effects were evaluated by determining the proportion of patients who achieved the lowest/highest possible raw score. Eight items showed DIF for language, but their impact on the test score was negligible. The item bank correlated, as hypothesized, moderately with the Dutch-Flemish PROMIS pain intensity item (Pearson's r = - 0.43) and strongly with the Disabilities of the Arm, Shoulder and Hand questionnaire, Subscale Disability/Symptoms (Spearman's ρ = - 0.87), the Functional Index for Hand Osteoarthritis (ρ = - 0.86), and the Michigan Hand Outcomes Questionnaire, Subscale Activities of Daily Living (ρ = 0.87). No patients achieved the lowest or highest possible raw score. A Dutch-Flemish PROMIS-UE item bank v2.0 has been developed that showed sufficient cross-cultural and construct validity as well as absence of floor and ceiling effects.

Translation, psychometric validation, and baseline results of the Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric measures to assess health-related quality of life of patients with pediatric lymphoma in Malawi.

Internationally validated tools to measure patient-reported health-related quality of life (HRQoL) are available, but efforts to translate and culturally validate such tools in sub-Saharan Africa (SSA) are scarce, particularly among children. The Patient-Reported Outcomes Measurement Information System 25-item pediatric short form (PROMIS-25) assesses six HRQoL domains-mobility, anxiety, depression, fatigue, peer relationships, and pain interference-by asking four questions per domain. There is a single-item pain intensity item. The PROMIS-25 was translated into Chichewa and validated for use in Malawi using mixed qualitative and quantitative methods. The validity and reliability of the PROMIS-25 was assessed. Fifty-four pediatric patients with lymphoma completed the PROMIS-25. Structural validity was supported by interitem correlations and principal component analysis. Reliability of each scale was satisfactory (range alpha=0.71-0.93). Known group validity testing showed that anemic children had worse fatigue (P=0.016) and children with poor performance status had worse mobility (P<0.001) and pain interference (P=0.005). Compared to children with cancer in the United States, children from Malawi reported lower levels of mobility, higher anxiety, higher depressive symptoms, higher fatigue, better satisfaction with peer relationships, and higher pain interference. Translation and cultural validation of the PROMIS-25 into Chichewa for Malawi was successful. Baseline HRQoL for patients with pediatric lymphoma in Malawi is poor for all domains except peer relationships. This emphasizes an urgent need to address HRQoL among children undergoing cancer treatment in SSA using self-reported instruments validated within the local context.

The Impact of Social Isolation on Pain Interference: A Longitudinal Study.

Evidence suggests social interactions play an important role in pain perception. The aim of this study was to determine whether social isolation (SI) in people with persistent pain determines pain interference (PI) and physical function over time. Patients seeking care at a tertiary pain management referral center were administered the Patient Reported Outcome Measurement Information System (PROMIS®) SI, PI, physical function, depression, and average pain intensity item banks at their initial consultation and subsequent visits as part of their routine clinical care. We used a post hoc simulation of an experiment using propensity score matching (n = 4,950) and carried out a cross-lagged longitudinal analysis (n = 312) of retrospective observational data. Cross-lagged longitudinal analysis showed that SI predicted PI at the next time point, above and beyond the effects of pain intensity and covariates, but not vice versa. These data support the importance of SI as a factor in pain-related appraisal and coping and demonstrate that a comprehensive assessment of the individuals' social context can provide a better understanding of the differential trajectories for a person living with pain. Our study provides evidence that the impact of pain is reduced in individuals who perceive a greater sense of inclusion from and engagement with others. This study enhances the understanding of how social factors affect pain and have implications for how the effectiveness of therapeutic interventions may be improved. Therapeutic interventions aimed at increasing social connection hold merit in reducing the impact of pain on engagement with activities.

Validation of the Standardized Universal Pain Evaluations for Rheumatology Providers for Children and Youth (SUPER-KIDZ).

Study Design Longitudinal observational clinimetric study with repeated measures. Background No validated multidimensional pain measure for children and youth with juvenile idiopathic arthritis exists. Objective To determine the test-retest reliability, construct validity, and responsiveness of English and French versions of the Standardized Universal Pain Evaluations for Rheumatology Providers for Children and Youth (SUPER-KIDZ). Methods Measurement properties of the SUPER-KIDZ (older child, younger child, and parent versions) were prospectively evaluated in patients (aged 4 to 18 years) with juvenile idiopathic arthritis at 2 centers. Internal consistency of the 3 subscales was measured using ordinal reliability alpha. Test-retest reliability for each subscale was evaluated with intraclass correlation coefficients (ICCs) from participants assumed to have stable pain (over a 1-week period with no change in treatment). Correlations of SUPER-KIDZ scores with validated measures determined construct validity. Responsiveness of SUPER-KIDZ subscales was evaluated in patients with improvement in pain, using standardized response mean and linear mixed-model regression. Results Seventy-one children aged 8 to 18 years and 29 parent-child dyads aged 4 to 7 years were included. Seventy-four percent of participants were female, with a median of 3 active joints (interquartile range, 1-5). Internal consistency was strong (α = .78-.96) for pain characteristics, interference, and emotional functioning SUPER-KIDZ subscales. Good test-retest reliability (ICC≥0.80) was found for the pain characteristics subscale in older- and younger-child versions. Most other subscales had satisfactory reliability coefficients (ICC≥0.70). Correlations of 0.50 or greater were found between the older-child SUPER-KIDZ scores and the Childhood Health Assessment Questionnaire and Patient-Reported Outcomes Measurement Information System depressive symptoms items, as well as the younger-child pain-intensity item and the Faces Pain Scale-Revised. Strong responsiveness was found for all subscales (standardized response mean, 0.63-1.54; significant linear mixed-model regression), except for the older-child emotional functioning subscale. Conclusion The SUPER-KIDZ has shown good internal consistency and responsiveness, and satisfactory test-retest reliability. Construct validity was moderate for the younger- and older-child versions, but weak for the parent version. J Orthop Sports Phys Ther 2017;47(10):731-740. Epub 4 Sep 2017. doi:10.2519/jospt.2017.7375.

Pain management intervention targeting nursing staff and general practitioners: Pain intensity, consequences and clinical relevance for nursing home residents

Although chronic pain is common in older adults, its treatment is frequently inappropriate. This problem is particularly prevalent in nursing home residents. We therefore developed an intervention to optimize pain management and evaluated its effects on pain intensity and pain interference with function in nursing home residents in Germany. In a cluster-randomized controlled intervention, 195 residents of 12 Berlin nursing homes who were affected by pain were surveyed at three points of measurement. A modified German version of the Brief Pain Inventory was used to assess pain sites, pain intensity and pain interference with function in various domains of life. The intervention consisted of separate training measures for nursing staff and treating physicians. The primary objective of reducing the mean pain intensity by 2points was not achieved, partly because the mean pain intensity at baseline was relatively low. However, marginal reductions in pain were observed in the longitudinal assessment at 6-month follow up. The intervention and control groups differed significantly in the intensity sum score and in the domain of walking. Furthermore, the proportion of respondents with pain scores >0 on three pain intensity items decreased significantly. Given the multifocal nature of the pain experienced by nursing home residents, improving the pain situation of this vulnerable group is a major challenge. To achieve meaningful effects not only in pain intensity, but especially in pain interference with function, training measures for nursing staff and physicians need to be intensified, and long-term implementation appears necessary. Geriatr Gerontol Int 2017; 17: 1534-1543.

How does pain experience relate to the need for pain relief? A secondary exploratory analysis in a large sample of cancer patients.

To explore (1) the information obtained from related but conceptually different approaches to pain assessment and (2) the extent to which the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) can be used as a screening tool to predict patient-reported need for pain relief. Cancer patients randomly sampled from 56 hospital departments were included. Questionnaire items assessed patients' (a) pain experience using the EORTC QLQ-C30 pain scale and its two pain items separately (pain intensity and pain interference) and (b) pain burden and (c) need for pain relief using the Three-Levels-of-Needs Questionnaire (3LNQ). Of the 2364 patients contacted by mail, 1447 (61%) completed the questionnaires. Among these, 51% reported at least "a little" pain on the pain intensity item. The number of patients reporting pain to be a burden was similar, and pain experience and pain burden were highly correlated (correlation coefficients ranged from 0.85 to 0.91). Pain experience and pain burden were moderately correlated with the need for pain relief. A receiver-operating characteristic (ROC) curve analysis showed that the EORTC QLQ-C30 discriminated between patients with and without a need for pain relief to an acceptable degree (area under the curve (AUC) 0.73-0.77). The cut-point a little gave a sensitivity of 84% and specificity of 59% for the item "Have you had pain?" and a sensitivity of 72% and a specificity of 72% for the pain scale. The majority of patients who experienced pain felt it to be a problem. Pain experience and pain burden were substantially related to need for pain relief, and the latter could be predicted from the EORTC QLQ-C30.

Using Linear Equating to Map PROMIS(®) Global Health Items and the PROMIS-29V2.0 Profile Measure to the Health Utilities Index Mark3.

Preference-based health-related quality of life (HR-QOL) scores are useful as outcome measures in clinical studies, for monitoring the health of populations, and for estimating quality-adjusted life-years. This was a secondary analysis of data collected in an internet survey as part of the Patient-Reported Outcomes Measurement Information System (PROMIS(®)) project. To estimate Health Utilities Index Mark3 (HUI-3) preference scores, we used the ten PROMIS(®) global health items, the PROMIS-29V2.0 single pain intensity item and seven multi-item scales (physical functioning, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, sleep disturbance), and the PROMIS-29V2.0 items. Linear regression analyses were used to identify significant predictors, followed by simple linear equating to avoid regression to the mean. The regression models explained 48% (global health items), 61% (PROMIS-29V2.0 scales), and 64% (PROMIS-29V2.0 items) of the variance in the HUI-3 preference score. Linear equated scores were similar to observed scores, although differences tended to be larger for older study participants. HUI-3 preference scores can be estimated from the PROMIS(®) global health items or PROMIS-29V2.0. The estimated HUI-3 scores from the PROMIS(®) health measures can be used for economic applications and as a measure of overall HR-QOL in research.

Qigong or Yoga Versus No Intervention in Older Adults With Chronic Low Back Pain-A Randomized Controlled Trial.

The aim of this study was to assess the effectiveness of the reduction of chronic lower back pain in older adults using either yoga classes or qigong classes compared with no intervention. Older adults (65years of age and older) with chronic low back pain were enrolled in and randomly allocated to: 1) yoga (24 classes, 45minutes each, during 3months), 2) qigong (12 classes, 90minutes each, during 3months), or 3) a control group who received no additional intervention. The pain intensity item of the Functional Rating Index after 3months was used as primary outcome parameter. A total of 176 patients were randomized (n=61 yoga, n=58 qigong, n=57 control; mean age73±5.6years, 89% female). The mean adjusted pain intensity after 3months was 1.71 for theyoga group (95% confidence interval [CI], 1.54-1.89), 1.67 for the qigong group (95% CI, 1.45-1.89), and 1.89 for no intervention (95% CI, 1.67-2.11). No statistically significant group differences were observed. Possible explanations for this lack of pain relief might include the ineffectiveness of interventions, inappropriate outcomes, or differences in pain perception and processing in older adults. The aim of this study was to assess the effectiveness of the reduction of chronic lower back pain in older adults using either yoga classes or qigong classes compared with no intervention. This 3-armed randomized trial with 176 older adults showed that yoga and qigong were not superior to no treatment in reducing pain and increasing quality of life.

MP31-18 UTILIZATION OF NIH PROMIS® TOOL FOR EVALUATION OF PATIENT REPORTED OUTCOMES IN UROLITHIASIS

You have accessJournal of UrologyGeneral & Epidemiological Trends & Socioeconomics: Practice Patterns, Quality of Life and Shared Decision Making III1 Apr 2016MP31-18 UTILIZATION OF NIH PROMIS® TOOL FOR EVALUATION OF PATIENT REPORTED OUTCOMES IN UROLITHIASIS Giulia Lane, Suzanne Neises, and Andrew Portis Giulia LaneGiulia Lane More articles by this author , Suzanne NeisesSuzanne Neises More articles by this author , and Andrew PortisAndrew Portis More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.1271AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The National Institutes of Health Patient Reported Outcome Measurement Information System (PROMIS®) is a validated system of questionnaires intended to measure patients′ symptoms and health-related quality of life across several domains. This is the first report of PROMIS® utilized through the course of acute stone management. METHODS PROMIS® Pain Intensity Short Form 3a and Pain Interference Short Form 6b were offered to all patients at a subspecialty kidney-stone clinic from 6/1/14-9/1/15. Pain intensity items address current, worst, and average pain severity in the preceding week. Pain interference items address life enjoyment and ability to concentrate and perform daily, recreational, and social activities. PROMIS® survey items consist of 5-point Likert scales, which are translated to normally distributed T-scores using a scoring guide. A T-score of 50 represents the American population mean. RESULTS A total of 1707 patients (age 52.0±16 years, 52% male, mean) completed 3965 surveys. Patients surveyed during acute phases of stone management reported T-scores one standard deviation above the mean (T-score>60) for pain interference more often than for pain intensity. (Table 1) Multivariate logistic regression demonstrates strong impact of phase of acute care relative to patients in long-term follow up. (Figure 1) New and post-operative patients were more likely than follow-up patients to report T-scores >60s for both domains. Whereas male patients and those >65 years old were less likely to report scores >60 in both domains. CONCLUSIONS This is the first report describing PROMIS® pain intensity and interference in urolithiasis. PROMIS® scores for these domains are responsive to the phase of acute care for urolithiasis and are influenced by age and gender. The finding of higher patient reported interference as compared to intensity may be useful in management of patient experience. Future association of PROMIS® pain scores with clinical outcomes may provide a valuable tool for stone management. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e426 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Giulia Lane More articles by this author Suzanne Neises More articles by this author Andrew Portis More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...