Quantifying Patient Expectations for Total Knee Arthroplasty: Expectations for Improvement Are Greater Than Minimal Clinically Important Difference.

BACKGROUND: Achieving a minimal clinically important difference (MCID) in patient-reported outcomes following total knee arthroplasty (TKA) is common, yet up to 20% patient dissatisfaction persists. Unmet expectations may explain post-TKA dissatisfaction. No prior studies have quantified patient expectations using the same patient-reported outcome metric as used for MCID to allow direct comparison. METHODS: This was a prospective study of patients undergoing TKA with 5 fellowship-trained arthroplasty surgeons at one academic center. Baseline Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference (PI) domains were assessed. Expected PROMIS scores were determined by asking patients to indicate the outcomes they were expecting at 12 months postoperatively. Predicted scores were generated from a predictive model validated in the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR) dataset. T-tests were used to compare baseline, expected, and predicted PROMIS scores. Expected scores were compared to PROMIS MCID values obtained from the literature. Regression models were used to identify patient characteristics associated with high expectations. RESULTS: There were 93 patients included. Mean age was 67 years (range, 30 to 85) and 55% were women. Mean baseline PROMIS PF and PI was 34.4 ± 6.7 and 62.2 ± 6.4, respectively. Patients expected significant improvement for PF of 1.9 times the MCID (MCID = 11.3; mean expected improvement = 21.6, 95% confidence interval [CI] 19.6 to 23.5, P < .001) and for PI of 2.3 times the MCID (MCID = 8.9; mean expected improvement = 20.6, 95% CI 19.1-22.2, P < .001). Predicted scores were significantly lower than expected scores (mean difference = 9.5, 95% CI 7.7 to 11.3, P < .001). No unique patient characteristics were associated with high expectations (P > .05). CONCLUSIONS: To our knowledge, this study is the first to quantify preoperative patient expectations using the same metric as MCID to allow for direct comparison. Patient expectations for improvement following TKA are ∼2× greater than MCID and are significantly greater than predicted outcome scores. This discrepancy challenges currently accepted standards of success after TKA and indicates a need for improved expectation setting prior to surgery.

Prevalence and burden of atopic dermatitis involving the head, neck, face, and hand: A cross sectional study from the TARGET-DERM AD cohort.

BACKGROUND: Atopic dermatitis (AD) is severely burdensome, and there has been poor characterization of any differences in impact based on the area affected. OBJECTIVE: To estimate the prevalence and HRQoL impact of head/face/neck/hand (HFNH) involvement among patients with moderate-to-severe atopic dermatitis. METHODS: All TARGET-DERM AD registry patients with moderate/severe Investigator Global Assessment (vIGA-AD) were assessed using the Patient Oriented SCORing Atopic Dermatitis, Patient Oriented Eczema Measure (POEM) and the (Children's) Dermatology Life Quality Index ((C)DLQI). RESULTS: 541 participants met the criteria (75.0% adults) and 84% (N = 453) reported HFNH involvement. HFNH and non-HFNH involved participants had similar characteristics; 55.2% female and 46.9% White. Compared to the non-HFNH involved, the involved had severe vIGA-AD (28.5% vs 16.3%, P = .02) and higher median body surface area affected (15% vs 10%, P ≤ .01) and were twice as likely to have higher (C)DLQI and POEM scores. LIMITATIONS: This was an analysis of real-world and patient reported outcome data. CONCLUSION: Real-world HFNH involved AD patients were associated with significantly worse quality of life, POEM/(C)DLQI, and more severe disease. Detailed assessments of specific areas affected by AD are needed to personalize treatment.

Outcome Measures and Patient-Reported Metrics in Cancer Rehabilitation.

PURPOSE OF REVIEW: The current panorama of measurement tools for use in cancer rehabilitation is reviewed. For rehabilitation purposes, evaluating function is of the highest priority. RECENT FINDINGS: From a patient-reported outcome (PRO) standpoint, SF-36 and EORTC-QLQ-C30 are in most common use in cancer rehabilitation research; these are quality of life measures that contain functional subdomains. Newer tools which are based on item response theory and have options for both computer assisted or short form (SF) administration, including the Patient-Reported Outcomes Measurement Information System (PROMIS) and Activity Measure for Post-acute Care (AMPAC) instruments, show increasing use, especially PROMIS Physical Function SF, and, recently, PROMIS Cancer Function Brief 3D, which has been validated in the cancer population, with domains of physical function, fatigue, and social participation, to track clinical rehabilitation outcomes. Evaluating objective measures of function in cancer patients is also crucial. Utilization of clinically feasible tools for cancer rehabilitation, to employ for both screening purposes and for monitoring of rehabilitation treatment efficacy, is an evolving area, much needed to promote further research and improved, consistent clinical care for cancer patients and survivors.

Responsiveness and interpretation of the PROMIS Cancer Function Brief 3D Profile.

BACKGROUND: Measuring function with valid and responsive tools in patients with cancer is essential for driving clinical decision-making and for the end points of clinical trials. Current patient-reported outcome measurements of function fall short for many reasons. This study evaluates the responsiveness of the Patient-Reported Outcomes Measurement Information System (PROMIS) Cancer Function Brief 3D Profile, a novel measure of function across multiple domains. METHODS: Two hundred nine participants across five geographically distinct tertiary care centers completed the assessment and pain rating at two outpatient cancer rehabilitation clinic visits. Patients and providers completed a global rating of change measure at the second visit to indicate whether the patient was improving or worsening in function. Multiple response indices and linear models measured whether the measure was responsive to self-reported and clinician-rated changes over time. Correlations between changes in function and changes in anchors (pain rating and performance status) were also calculated. RESULTS: Function as measured by the PROMIS Cancer Function Brief 3D Profile changed appropriately as both patients and clinicians rated change. Small to moderate effect sizes supported the tool's responsiveness. Function was moderately correlated with pain and more strongly correlated with performance status, and changes in function corresponded with changes in anchor variables. No floor/ceiling effect was found. CONCLUSIONS: The PROMIS Cancer Function Brief 3D Profile is sensitive to changes over time in patients with cancer. The measure may be useful in clinical practice and as an end point in clinical trials. LAY SUMMARY: We gave patients a questionnaire by which they told their physicians how well they were functioning, including how fatigued they were. This study tested that questionnaire to see whether the scores would change if patients got better or worse.

Health-related quality of life of people living with HIV/AIDS: the role of social inequalities and disease-related factors.

BACKGROUND: Health-related quality of life (HRQoL) serves as a direct measure of individuals' health, life expectancy and the impact that the utilization of health care has on quality of life. The purpose of this study is to assess the HRQoL of people living with HIV (PLHIV), and to ascertain its association with the social inequalities and clinical determinants among people living with HIV in Benishangul Gumuz Regional State, Ethiopia. METHODS: A cross-sectional study was conducted between December 2016 and February 2017; 390 people at two referral hospitals and three health centers participated in the study. The Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS Global 10) was used to measure key HRQoL domains. Global Physical Health (GPH) and Global Mental Health (GPH) summary scores were employed. GPH and GMH summary scores below 50 (the standardized mean score) were determined as poor HRQoL. Bivariate and multivariate logistic regression analyses were used to identify factors associated with GPH and GMH summary scores. RESULTS: This study included 259 (66.4%) females and 131 (33.6%) males. The GPH summary scores ranged from 16.2 to 67.7 with a mean of 48.8 (SD = 8.9). Almost 44.6% of the study population has a GPH summary score of below 50; the GMH summary scores ranged from 28.4 to 67.6 with a mean of 50.8 (SD = 8.1). About 41.8% of the study population has a GMH summary score of below 50. Unemployment, household food insecurity and comorbidities with HIV were associated with both poor GPH and poor GMH summary scores. Age below 25 years and being a member of Christian fellowship were inversely associated with poor GPH. The least wealth index score and CD4 count below 350 cells/mL were also associated with poor GMH. CONCLUSION: Overall, socioeconomic inequalities and HIV-related clinical factors play an important role in improving the HRQoL of PLHIV. Many of these determinants are alterable risk factors. Appropriate strategies can improve the holistic management of chronic HIV care and maximize PLHIVs' HRQoL. Such strategies require the adoption of comprehensive interventions, including policies and programmes that would improve the health, wellbeing and livelihood of PLHIV.

Cross-sectional validation of the PROMIS-Preference scoring system by its association with social determinants of health.

PURPOSE: PROMIS-Preference (PROPr) is a generic, societal, preference-based summary score that uses seven domains from the Patient-Reported Outcomes Measurement Information System (PROMIS). This report evaluates construct validity of PROPr by its association with social determinants of health (SDoH). METHODS: An online panel survey of the US adult population included PROPr, SDoH, demographics, chronic conditions, and four other scores: the EuroQol-5D-5L (EQ-5D-5L), Health Utilities Index (HUI) Mark 2 and Mark 3, and the Short Form-6D (SF-6D). Each score was regressed on age, gender, health conditions, and a single SDoH. The SDoH coefficient represents the strength of its association to PROPr and was used to assess known-groups validity. Convergent validity was evaluated using Pearson correlations between different summary scores and Spearman correlations between SDoH coefficients from different summary scores. RESULTS: From 4142 participants, all summary scores had statistically significant differences for variables related to education, income, food and financial insecurity, and social interactions. Of the 42 SDoH variables tested, the number of statistically significant variables was 27 for EQ-5D-5L, 17 for HUI Mark 2, 23 for HUI Mark 3, 27 for PROPr, and 27 for SF-6D. The average SDoH coefficients were - 0.086 for EQ-5D-5L, - 0.039 for HUI Mark 2, - 0.063 for HUI Mark 3, - 0.064 for PROPr, and - 0.037 for SF-6D. Despite the difference in magnitude across the measures, Pearson correlations were 0.60 to 0.76 and Spearman correlations were 0.74 to 0.87. CONCLUSIONS: These results provide evidence of construct validity supporting the use of PROPr monitor population health in the general US population.

Does the Patient-Reported Outcomes Measurement Information System Correlate to Legacy Scores in Measuring Physical Health in Young Total Hip Arthroplasty Patients?

BACKGROUND: The Patient-Reported Outcomes Measurement Information System (PROMIS) was developed by the National Institutes of Health to collect outcome data in rapid dynamic fashion on electronic platforms. The potential role of PROMIS in monitoring pain and function in young total hip arthroplasty (THA) patients has been under-investigated. The purpose of this study is to investigate correlation between PROMIS Physical Function (PF) and PROMIS Pain Interference (PI) and legacy scores with similar considerations. METHODS: We identified 298 hips who underwent primary THA over 40 months. Patients without preoperative PROMIS or legacy scores, or >50 years were excluded. Demographic data included age, gender, and body mass index. Outcome data included PF, PI, modified Harris Hip Score (mHHS), Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) domains, and Short Form 12 components. Floor/ceiling effects were considered to be significant if ≥15% of patients responded with the lowest or highest possible score. Spearman correlation (R) was performed to investigate correlation between legacy scores and PROMIS domains. RESULTS: Mean age was 40 years, mean body mass index was 30.1 kg/m2, and 55% were female. None of the patient-reported outcome measures showed any floor/ceiling effects. PI showed moderate correlation to mHHS (R = -0.60), WOMAC Pain (R = -0.62), and WOMAC PF (R = -0.60). PF showed moderate correlation to mHHS (R = 0.66) and WOMAC PF (R = 0.55). Mean PF and PI scores differed significantly from the general population mean of 50 (36.7, 65.4, respectively; both P < .001). CONCLUSION: PROMIS is an attractive alternative to legacy scoring measures, showing moderate correlations between PROMIS physical domains and legacy PROMs of WOMAC and mHHS in young patients undergoing THA.

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

PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Measuring physical and mental health during pregnancy and postpartum in an Australian childbearing population - validation of the PROMIS Global Short Form.

BACKGROUND: Health related quality of life is a critical concept during the perinatal period but remains under-researched. The International Consortium for Health Outcomes Measurement have included the Patient Reported Outcomes Measurement Information System (PROMIS®) Global Short Form (GSF) in their core outcome set for pregnancy and childbirth to measure health related quality of life. The PROMIS GSF has not been fully evaluated as a valid and reliable instrument in this population. This study assessed the psychometric properties of the PROMIS GSF during pregnancy and postpartum period. METHODS: PROMIS GSF was administered to a sample of 309 pregnant women at four time-points during pregnancy (≤ 27 and 36-weeks) and postpartum (6- and 26-weeks). The structural validity, internal consistency reliability, construct validity, and responsiveness of the PROMIS GSF were evaluated. The internal structure of the PROMIS GSF was explored using Rasch Measurement Theory. Response format, item fit, differential item functioning (item bias), dimensionality of the scale and its targeting were assessed. RESULTS: Two revised subscales (Mental Health: four items; and Physical Health: five items) showed good fit to the Rasch model. The revised mental health subscale demonstrated good internal consistency reliability during pregnancy and postpartum period (α = .88 and .87, respectively). The internal consistency reliability of the physical health subscale was adequate (α = .76 and .75, respectively). The revised mental health subscale was sensitive to group differences according to a history of mental health disorder, income, smoking status, drug use, stress levels and planned versus unplanned pregnancy. Differences in scores on the revised physical subscale were detected for groups based on obesity, income, drug use, smoking status, stress, and history of mental health disorders. Scores on both subscales recorded significant changes across the four time-points, spanning pregnancy and postpartum period. CONCLUSIONS: The revised version of the PROMIS GSF was better able to measure mental and physical health during pregnancy and postpartum period compared to the original version. Findings support the clinical and research application of the PROMIS GSF within the International Consortium for Health Outcomes Measurement Standard Set of Outcome Measures for Pregnancy and Childbirth. Ongoing psychometric analysis of the PROMIS GSF is recommended in other maternity populations.

Effects of Baseline Opioid Medication Use on Patient-Reported Functional and Psychological Impairment Among Hand Clinic Patients.

PURPOSE: To test the null hypothesis that baseline opioid use is not associated with functional or psychological impairment among new hand surgery clinic patients, as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) instruments. METHODS: New adult (≥ 18 years) patient visits to a tertiary academic orthopedic nonshoulder hand and upper extremity clinic between February 2014 and April 2018 were eligible. Collected outcomes include the question, "Are you currently taking narcotic pain medications?", the PROMIS Upper Extremity (UE) computerized adaptive testing (CAT), abbreviated version of the Disorders of the Arm, Shoulder, and Hand (QuickDASH), PROMIS Physical Function (PF) CAT, PROMIS Pain Interference (PI) CAT, PROMIS Depression CAT, and PROMIS Anxiety CAT. Patients responding to the opioid question, plus the UE CAT or QuickDASH, were included. Bivariate and multivariable logistic regression modelling were used to assess factors associated with baseline scores. RESULTS: Of 5997 included patients, 1,046 (17.4%) reported baseline opioid use. Patients in the opioid group demonstrated significantly worse scores on all patient-reported outcomes, and a significantly greater proportion of patients with PROMIS Depression CAT scores exceeding 60 (associated with a clinical diagnosis of depression; 29.5% vs 15.5%). Lower functional scores were observed in the opioid group after controlling for age, sex, other activity-limiting comorbidities, and either depression (UE CAT -7.0; QuickDASH +18.1; and PF CAT -6.6 points), anxiety (UE CAT -6.3; QuickDASH +16.4; PF CAT -6.3), or PI (UE CAT -3.7; QuickDASH +9.5; and PF CAT -4.2 points). Pain interference was greater among opiate users when controlling for age, sex, other activity-limiting comorbidities, and baseline function or psychological status: PI was 2.5, 5.0, or 4.3 points greater when controlling for the PROMIS UE CAT, Depression CAT, or Anxiety CAT. CONCLUSIONS: New patients presenting to a hand surgery clinic who endorse use of opioid medications at baseline report significantly decreased physical function, increased psychological burden, and greater levels of pain interference than nonusers. TYPE OF STUDY/LEVEL OF EVIDENCE: Diagnostic III.

Evaluation of Version 2.0 of the PROMIS Upper Extremity Computer Adaptive Test in Nonshoulder Upper Extremity Patients.

PURPOSE: The Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Computer Adaptive Test (UE CAT) was recently updated to version 2.0 (v2.0). We hypothesized that the PROMIS UE CAT v2.0 would exhibit improved performance characteristics compared with the Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) when administered to a nonshoulder upper extremity patient population. METHODS: The UE CAT v2.0, Physical Function (PF) CAT v2.0, and the QuickDASH were each prospectively administered via tablet computer to all patients presenting to a tertiary hand and upper extremity clinic between April 2017 and October 2017. Patient responses were analyzed, and the mean, range, floor and ceiling effect, and correlations between instruments were calculated. RESULTS: Among 825 patients, the mean UE CAT v2.0 score was 38.3 (SD 10.7) with a range of 15 to 61 and interquartile range of 15.4. The UE CAT v2.0 had a strong correlation with the QuickDASH (r = -0.749) and the PF CAT v2.0 (r = 0.719). No patient scored between 56 and 60, indicating a gap in scoring in that range. The UE CAT v2.0 demonstrated a floor effect of 1%, a ceiling effect of 6.9%, and a high internal consistency with a Cronbach alpha of 0.99. CONCLUSIONS: The PROMIS UE CAT v2.0 demonstrated improved ceiling effects, range, and a decreased gap in scoring compared with prior versions. Limitations of the PROMIS UE CAT v2.0 are still present, but updates have led to an incremental improvement over prior versions, demonstrating the ability to influence PROMIS instrument performance through upgrades. CLINICAL RELEVANCE: The updated PROMIS UE CAT v2.0 still demonstrates a ceiling effect and gap in scores at the upper end of the instrument, both of which may limit discrimination between different levels of upper extremity function for high-functioning patients.

Physical function metric over measure: An illustration with the Patient-Reported Outcomes Measurement Information System (PROMIS) and the Functional Assessment of Cancer Therapy (FACT).

BACKGROUND: Measuring patient-reported outcomes (PROs) is becoming an integral component of quality improvement initiatives, clinical care, and research studies in cancer, including comparative effectiveness research. However, the number of PROs limits comparability across studies. Herein, the authors attempted to link the Functional Assessment of Cancer Therapy-General Physical Well-Being (FACT-G PWB) subscale with the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) calibrated item bank. The also sought to augment a subset of the conceptually most similar FACT-G PWB items with PROMIS PF items to improve the linking. METHODS: Baseline data from 5506 participants in the Measuring Your Health (MY-Health) study were used to identify the optimal items for linking FACT-G PWB with PROMIS PF. A mixed methods approach identified the optimal items for creating the 5-item FACT/PROMIS-PF5 scale. Both the linked and augmented relationships were cross-validated using the follow-up MY-Health data. RESULTS: A 5-item FACT-G PWB item subset was found to be optimal for linking with PROMIS PF. In addition, a 2-item subset, including only items that were conceptually very similar to the PROMIS item bank content, were augmented with 3 PROMIS PF items. This new FACT/PROMIS-PF5 provided superior score recovery. CONCLUSIONS: The PROMIS PF metric allows for the evaluation of the extent to which similar questionnaires can be linked and therefore expressed on the same metric. These results allow for the aggregation of existing data and provide an optimal measure for future studies wishing to use the FACT yet also report on the PROMIS PF metric. Cancer 2018;124:153-60. © 2017 American Cancer Society.

PROMIS measures can be used to assess symptoms and function in long-term hematopoietic cell transplantation survivors.

BACKGROUND: Patient-reported outcomes for hematopoietic cell transplantation (HCT) survivors are well characterized with established measures; however, there is little experience with the new, freely available Patient-Reported Outcomes Measurement Information System (PROMIS) measures in this population. The aim of this study was to compare the performance of the PROMIS measures in the HCT setting with the performance of the commonly used 36-Item Short Form Health Survey (SF-36). METHODS: Adult HCT survivors from the Fred Hutchinson Cancer Research Center (n = 4446) were mailed a survey that included the following as part of an annual follow-up survey: the Patient-Reported Outcomes Measurement Information System-Global Health (PROMIS-GH; 10 questions), the 29-Item Patient-Reported Outcomes Measurement Information System Profile (PROMIS-29), and the SF-36. RESULTS: Both the SF-36 and PROMIS measures were available for 1634 HCT recipients (503 autologous recipients and 1131 allogeneic recipients). The overall response rate was 46%. The median time after transplantation for allogeneic and autologous recipients was 12.0 years (range, 0.4-44.1 years) and 6.1 years (range, 0.4-30.1 years), respectively. With the SF-36 or PROMIS-GH, overall physical functioning was somewhat lower in comparison with the general population, but mental functioning was similar. Component and domain scores with similar contents were strongly correlated by Pearson correlation coefficients: the Global Health-Physical and SF-36 Physical Component Summary scores for autologous (r = 0.82) and allogeneic recipients (r = 0.83) and the PROMIS-29 and SF-36 physical function, pain, and vitality/fatigue scores for allogeneic (0.87, -0.82, and -0.82, respectively) and autologous recipients (0.84, -0.82, and -0.81, respectively). The correlation between the Global Health-Mental and SF-36 Mental Component Summary scores was lower (0.70 for autologous recipients and 0.72 for allogeneic recipients). CONCLUSIONS: Physical and mental symptoms and function in autologous and allogeneic HCT survivors can be adequately assessed with PROMIS-29 and PROMIS-GH. Cancer 2018;124:841-9. © 2017 American Cancer Society.

Ensuring content validity of patient-reported outcomes: a shadow-test approach to their adaptive measurement.

PURPOSE: Most computerized adaptive testing (CAT) applications in patient-reported outcomes (PRO) measurement to date are reliability-centric, with a primary objective of maximizing measurement efficiency. A key concern and a potential threat to validity is that, when left unconstrained, individual CAT administrations could have items with systematically different attributes, e.g., sub-domain coverage. This paper aims to provide a solution to the problem from an optimal test design framework using the shadow-test approach to CAT. METHODS: Following the approach, a case study was conducted using the PROMIS® (Patient-Reported Outcomes Measurement Information System) fatigue item bank both with empirical and simulated response data. Comparisons between CAT administrations without and with the enforcement of content and item pool usage constraints were examined. RESULTS: The unconstrained CAT exhibited a high degree of variation in items selected from different substrata of the item bank. Contrastingly, the shadow-test approach delivered CAT administrations conforming to all specifications with a minimal loss in measurement efficiency. CONCLUSIONS: The optimal test design and shadow-test approach to CAT provide a flexible framework for solving complex test-assembly problems with better control of their domain coverage than for the conventional use of CAT in PRO measurement. Applications in a wide array of PRO domains are expected to lead to more controlled and balanced use of CAT in the field.

Feasibility and diagnostic accuracy of the Patient-Reported Outcomes Measurement Information System (PROMIS) item banks for routine surveillance of sleep and fatigue problems in ambulatory cancer care.

BACKGROUND: Routine screening for problematic symptoms is emerging as a best practice in cancer systems globally. The objective of this observational study was to assess the feasibility and diagnostic accuracy of Patient-Reported Outcomes Measurement Information System (PROMIS) computerized adaptive testing (CAT) for fatigue and sleep-disturbance items compared with legacy measures in routine ambulatory cancer care. METHODS: Patients who attended outpatient clinics at the Princess Margaret Cancer Center completed PROMIS CAT item banks and legacy measures (the Functional Assessment of Chronic Illness Therapy [FACIT]-Fatigue scale and the Insomnia Severity Index [ISI]) using tablet computers during clinic visits. The completion rates, patient acceptability, and diagnostic accuracy of PROMIS CAT were evaluated against legacy measures using receiver operating characteristic (ROC) curve analysis. RESULTS: Participants consisted of 336 patients (mean age ± standard deviation, 57.4 ± 15.7 years; 55% females; 75% Caucasian). Over 98% of patients did not find symptom screening was burdensome, although only 65% were willing to complete the survey at every visit. PROMIS CAT scores were significantly correlated with both FACIT-Fatigue scores (r = -0.83) and ISI scores (r = -0.57; p < 0.0001 for all). Areas under the curve (AUC) by ROC analysis for fatigue were 0.946 using the FACIT-Fatigue cutoff ≤30, 0.910 for sleep disturbance, and 0.922 for sleep impairment using the ISI cutoff ≥15. The recommended T-score cut-off for PROMIS CAT Fatigue was 57, Sleep Disturbance was 57, and Sleep Impairment was 57. CONCLUSIONS: The current results support the feasibility and accuracy of PROMIS CAT and its potential for use in routine ambulatory cancer care. Future research will assess feedback of these data to clinicians and evaluate effects on earlier identification of and intervention for these problems. Cancer 2016. © 2016 American Cancer Society. Cancer 2016;122:2906-2917. © 2016 American Cancer Society.

Responsiveness to Change in PROMIS(®) Measures among Children with Asthma: A Report from the PROMIS(®) Pediatric Asthma Study.

OBJECTIVE: To compare the responsiveness to change of the Patient-Reported Outcomes Measurement Information System (PROMIS(®)) asthma impact, pain interference, fatigue, depressive symptoms, mobility, and peer relationship scales to a legacy scale, the Paediatric Asthma Quality of Life Questionnaire (PAQLQ). METHODS: Two hundred and twenty-nine child-parent dyads from public insurance programs were enrolled. PROMIS pediatric short forms (SFs) and the PAQLQ were used to measure health-related quality of life across four time points (T1-T4) over 2 years. The Asthma Control and Communication Instrument was used to measure the change in asthma control, and the Global Rating of Change (GRC) Index for breathing problems and overall health was used to measure the change in health status. Responsiveness was tested by comparing the changes in health-related quality of life with the changes in asthma control and health status over time using t tests, generalized estimating equations, and relative validity approaches. Magnitudes of the responsiveness between the Pediatric PROMIS and PAQLQ were assessed through statistical significance, Cohen's d effect size (ES), and standardized response mean (SRM). RESULTS: The PROMIS asthma impact scale and all PAQLQ scales exhibited significant responsiveness (p's<0.05) and small to medium ES/SRM when anchored to asthma control, GRC breathing problems, and overall health. Relative validity, especially related to change in asthma control status and GRC breathing problems, was equivalent. PROMIS pain interference, fatigue, and mobility SFs also indicated adequate responsiveness. CONCLUSIONS: The PROMIS asthma impact SF indicated similar responsiveness to the PAQLQ scales. Due to its brevity and responsiveness, the PROMIS asthma impact SF is useful for clinical practice or research.

Known-groups validity of the Patient-Reported Outcomes Measurement Information System (PROMIS(®)) in adolescents and young adults with special healthcare needs.

PURPOSE: To examine known-groups validity of the Patient-Reported Outcomes Measurement Information System (PROMIS(®)) Short Forms (SFs) for adolescents and young adults with special healthcare needs (SHCN) using data collected from the PROMIS Linking Study. METHODS: In total, 292 adolescents aged 14-17.9 years and 300 young adults aged 18-20 years with SHCN from the PROMIS Linking Study were used for analyses. Presence of SHCN was classified into three categories (medication use, service use, and functional limitations). HRQoL was measured with the PROMIS Pediatric and Adult SFs. Differences in health-related quality of life (HRQoL) domain scores between SHCN sample and the norms of the PROMIS pediatric and adult calibration samples, respectively, were compared using t tests. Associations of HRQoL scores with the presence of individual SHCN categories were tested using linear regression. RESULTS: All HRQoL domain scores for the SHCN samples were significantly worse than the respective calibration samples. Adolescents and young adults with SHCN-related service use and functional limitations reported worse HRQoL than those without service use and functional limitations (p's < 0.01). CONCLUSIONS: PROMIS Pediatric and Adult SFs possess satisfactory known-groups validity related to SHCN status.

The Emotion Dysregulation Inventory-Young Child: Psychometric Properties and Item Response Theory Calibration in 2- to 5-Year-Olds.

OBJECTIVE: The Emotion Dysregulation Inventory (EDI) was designed and validated to quantify emotion dysregulation (ED) in children aged 6+ years. The purpose of this study was to adapt the EDI for use in young children (EDI-YC). METHOD: Caregivers of 2,139 young children (aged 2-5 years) completed 48 candidate EDI-YC items. Factor and item response theory (IRT) analyses were conducted separately for clinical (neurodevelopmental disabilities; N = 1,369) and general population (N = 768) samples. The best-performing items across both samples were selected. Computerized adaptive testing simulations were used to develop a short-form version. Concurrent calibrations and convergent/criterion validity analyses were performed. RESULTS: The final calibrated item banks included 22 items: 15 items for Reactivity, characterized by rapidly escalating, intense, and labile negative affect, and difficulty down-regulating that affect; and 7 items for Dysphoria, characterized primarily by poor up-regulation of positive emotion, as well an item each on sadness and unease. The final items did not show differential item functioning based on age, sex, developmental status, or clinical status. IRT co-calibration of the EDI-YC Reactivity with psychometrically robust measures of anger/irritability and self-regulation demonstrated its superiority in assessing emotion dysregulation in as few as 7 items. EDI-YC validity was supported by expert review and its association with related constructs (eg, anxiety, depression, aggression, temper loss). CONCLUSION: The EDI-YC captures a broad range of emotion dysregulation severity with a high degree of precision in early childhood. It is suitable for use in all children aged 2 to 5 years, regardless of developmental concerns, and would be an ideal broadband screener for emotional/behavioral problems during well-child checks and to support early childhood irritability and emotion regulation research.

Do Maladaptive Imaging Beliefs Predict Self-Reported Pain Interference and Physical Function in Patients With Musculoskeletal Disorders?

OBJECTIVE: To determine if maladaptive imaging beliefs correlated with, and predicted pain interference and physical function outcomes in people with musculoskeletal pain disorders. DESIGN: A prospective cohort study of patients with musculoskeletal disorders receiving outpatient physical therapy from April 2022 to August 2023. METHODS: Four questions about imaging were asked to assess maladaptive beliefs, the need to rule out serious conditions, guide treatment, determine diagnosis, and validate symptoms. Correlations with beliefs and outcomes were assessed using Kendall's tau rank and Spearman's rho correlation coefficients. Generalized linear models determined if these beliefs predicted outcomes at baseline and 6 weeks. RESULTS: The cohort included 152 participants (mean [standard deviation] age: 56.13 [15.13]; 32.2% male). Maladaptive imaging beliefs correlated positively with pain interference and negatively with physical function. The need to rule out serious conditions and validate symptoms correlated with pain interference (range: τb = 0.17, 0.20; P = .003, .0121) and physical function (range: ρ = -0.22, -0.22; P = .006, .008). All but 1 belief correlated with pain interference (range: τb = 0.19, 0.24; P<.001, .004) and physical function (range: ρ = -0.26, -0.21; P = .001, .009) at 6 weeks. Each additional belief slightly increased pain interference at 6 weeks (ß = 0.01; 95% CI: 0.001, 0.03; P = .04) and lowered physical function at both baseline (ß = -0.97; 95% CI: -1.66, -0.28; P = .01) and 6 weeks (ß = -0.76; 95% CI: -1.37, -0.15; P = .02). CONCLUSION: Maladaptive imaging beliefs were significantly (albeit weakly) correlated with pain and physical function. Each additional maladaptive imaging belief increased pain interference at 6 weeks and lowered physical function at baseline and 6 weeks. Beliefs about the necessity of imaging to properly manage musculoskeletal disorders may influence outcomes. J Orthop Sports Phys Ther 2024;54(9):1-10. Epub 5 July 2024. doi:10.2519/jospt.2024.12625.

Telemedicine-Based Digital Cognitive Behavioral Intervention for Perioperative Anxiety and Depression for Total Knee Arthroplasty.

Introduction: Preoperative anxiety and depression have been shown to increase postoperative pain and opioid consumption by up to 50% in patients undergoing primary unilateral Total Knee Arthroplasty (TKA). We hypothesized that the use of a telemedicine-based digital Cognitive Behavioral Intervention program (RxWell®) started one month prior to surgery would control anxiety and depression prior to surgery. Materials and methods: This was a randomized, controlled trial that enrolled patients undergoing primary unilateral TKA. At least a month prior to surgery, patients who gave consent to participate were asked to complete PROMIS® (Patient-Reported Outcomes Measurement Information System) emotional anxiety short form 8a and PROMIS® emotional depression short form-8a questionnaires. Patients with T-scores of ≥ 57 were randomized to either a no intervention (control group) or a RxWell® program (treatment group) for a month prior to surgery. The primary outcome of this proof-of-concept study was the ability of the RxWell® to normalize patients' PROMIS anxiety T scores. Results: T scores for anxiety and depression among patients randomized to the RxWell® group significantly decreased from 64.3 ± 3.0 at the time of randomization to 58.5 ± 2.6 prior to surgery (n=5, p=0.006), whereas no changes in T scores were recorded in the control group (59.4 ± 4.2 at the time of randomization vs. 57.7 ± 6.2; n=6, p=0.559). Conclusion: These preliminary data suggest that the use of a RxWell® program represents an effective approach to control anxiety and depression prior to surgery. In contrast, it seems that in the absence of treatment, anxiety level remains similar over a month prior to surgery.