Feasibility and Clinical Utility of Patient-Reported Outcome Measurement Information System-29 in a Newly Established Adolescent and Young Adult Oncology Program.

Purpose: Despite improvements in survival, adolescent and young adult (AYA) oncology patients are at high risk for experiencing negative health-related quality of life (HRQOL) outcomes. AYA cancer programs have attempted to develop assessment tools to identify areas of need. We aimed to demonstrate the feasibility/utility of the Patient-Reported Outcome Measurement Information System®-29 (PROMIS®-29) within an AYA oncology program clinic. Methods: AYA patients were referred by oncologists to the AYA oncology program at Prisma Health. The PROMIS-29 v2.0 survey was administered to AYAs at point of care. Feasibility of distribution and completion rate of surveys were determined. PROMIS surveys were self-reported and subsequently scored using standardized methods. The domains assessed included physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles/activities, pain interference, and pain intensity. Qualitative descriptions of AYA care delivery based on survey responses at the patient level and programmatic level are also presented. Results: Between May 2017 and 2019, 134 AYAs who were newly diagnosed or in treatment completed the survey. Distribution and completion rates for the PROMIS-29 were both 100%, and meaningful changes in program-level services were implemented as a result of PROMIS-29 score patterns. Within the entire cohort, T-scores for anxiety, fatigue, and physical function reached clinically relevant thresholds. Conclusion: PROMIS offers a feasible opportunity for AYA programs to measure clinically useful HRQOL outcomes in AYAs. The survey can be used to deliver real-time AYA care to recently diagnosed and in-treatment AYAs and make programmatic changes within AYA oncology programs.

Impact of the COVID-19 pandemic on psychosocial health in rheumatic patients: A longitudinal study.

AIM: To describe the impact of the COVID-19 on the psychosocial health of patients with rheumatoid arthritis (RA), spondyloarthritis (SpA), and systemic lupus erythematosus (SLE). DESIGN: Longitudinal observational study of a series of patients with rheumatic disease. METHODS: The main outcome measure was impairment of the ability to participate in social activities, as measured using the PROMIS-APS instrument Short Form-8a. We evaluated social activities in various settings and performed a multivariate analysis to study the association between worsening of social participation during the COVID-19 pandemic and implicated factors. RESULTS: One hundred and twenty-five patients had completed the prospective follow-up: 40 with AR (32%), 42 with SpA (33.6%), and 43 with SLE (34.4%). Overall, poorer mean PROMIS scores were recorded after the COVID-19 pandemic for: satisfaction with social roles (p=0.029), depression (p=0.039), and ability to participate in social activities (p=0.024). The factors associated with ability to participate in social activities after the COVID-19 pandemic were older age (ß=-0.215; p=0.012), diagnosis of SLE (ß=-0.203; p=0.015), depression (ß=-0.295; p=0.003) and satisfaction with social roles (ß=0.211; p=0.037). CONCLUSION: The ability to participate in social activities after the COVID-19 pandemic is affected in patients with rheumatic disease, especially in SLE.

Proximal humerus open reduction internal fixation with and without biceps tenodesis: assessment of early clinical outcomes.

Background: The role of biceps tenodesis (BT) during open reduction internal fixation (ORIF) of proximal humerus fractures (PHFs) remains unclear. A subset of patients undergoing ORIF have persistent pain with unclear etiology. The purpose of our study was to compare outcomes of ORIF of PHFs with and without concomitant BT. We hypothesize patients undergoing BT at the time of ORIF will have improved patient-reported outcome scores with fewer secondary procedures related to treatment of the biceps. Methods: In this retrospective cohort study, all patients undergoing ORIF for a PHF at a single level one trauma center from January 2019 to June 2022 were reviewed. Patients under the age of 18 were excluded. Primary outcomes were patient-reported outcomes measurement information system physical function, depression, and pain interference scores at 5 time points up to final follow-up. Secondary outcomes included total operative time, complications, subsequent procedures, steroid injections, and range of motion. Chi-square tests were performed for categorical values and paired t-tests for continuous variables. Results: 71 patients met inclusion criteria: 41 undergoing ORIF without BT and 30 undergoing ORIF with BT. Average follow-up was 11 months. There were no statistically significant differences in patient demographics between groups. There were no differences in patient-reported outcomes measurement information system scores at any time point postoperatively. At final follow-up patients in the ORIF with BT group had higher forward flexion than those who did not undergo BT (142 vs. 123 degrees, respectively, P < .02). There were no differences in surgical time, revision rates, postsurgical complications, or postoperative injections between groups. Conclusion: BT performed during ORIF of PHFs did not result in significantly different functional or patient-reported outcomes between groups, except for greater forward flexion at final follow-up. Although BT was done more commonly in severe PHFs, patients in both groups had similar rates of subsequent biceps-related procedures and revision surgery.

Comparison of the EQ-5D-5L and the patient-reported outcomes measurement information system preference score (PROPr) in the United States.

BACKGROUND: In contrast to prior research, our study presents longitudinal comparisons of the EQ-5D-5L and Patient-Reported Outcomes Measurement Information System (PROMIS) preference (PROPr) scores. This fills a gap in the literature, providing a much-needed understanding of these preference-based measures and their applications in healthcare research. Furthermore, our study provides equations to estimate one measure from the other, a tool that can significantly facilitate comparisons across studies. METHODS: We administered a health survey to 4,098 KnowledgePanel® members living in the United States. A subset of 1,256 (82% response rate) with back pain also completed the six-month follow-up survey. We then conducted thorough cross-sectional and longitudinal analyses of the two measures, including product-moment correlations between scores, associations with demographic variables, and health conditions. To estimate one measure from the other, we used ordinary least squares (OLS) regression with the baseline data from the general population. RESULTS: The correlation between the EQ-5D-5L and PROPr scores was 0.69, but the intraclass correlation was only 0.34 because the PROPr had lower (less positive) mean scores on the 0 (dead) to 1 (perfect health) continuum than the EQ-5D-5L. The associations between the two preference measures and demographic variables were similar at baseline. The product-moment correlation between unstandardized beta coefficients for each preference measure regressed on 22 health conditions was 0.86, reflecting similar patterns of unique associations. Correlations of change from baseline to 6 months in the two measures with retrospective perceptions of change were similar. Adjusted variance explained in OLS regressions predicting one measure from the other was 48%. On average, the predicted values were within a half-standard deviation of the observed EQ-5D-5L and PROPr scores. The beta-binomial regression model slightly improved over the OLS model in predicting the EQ-5D-5L from the PROPr but was equivalent to the OLS model in predicting the PROPr. CONCLUSION: Despite substantial mean differences, the EQ-5D-5L and PROPr have similar cross-sectional and longitudinal associations with other variables. We provide the OLS regression equations for use in cost-effectiveness research and meta-analyses. Future studies are needed to compare these measures with different conditions and interventions to provide more information on their relative validity.

Qualitative and Psychometric Evaluation of 29-Item Patient-Reported Outcomes Measurement Information System® to Assess General Health-Related Quality of Life in Patients With Moderately to Severely Active Inflammatory Bowel Disease.

OBJECTIVES: To evaluate content validity and psychometric properties of the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS-29) to determine its suitability in inflammatory bowel disease (IBD) clinical trials. METHODS: Content validity of PROMIS-29 was evaluated using qualitative interviews, including concept elicitation and cognitive debriefing, among patients living with Crohn's disease (Crohn's disease n = 20) or ulcerative colitis (UC, n = 19). PROMIS-29 validity, reliability, and responsiveness were assessed using data from phase II clinical trials of Crohn's disease (N = 360) and UC (N = 518). RESULTS: Common (≥74%) symptoms reported in qualitative interviews were increased stool frequency, fatigue, abdominal pain/cramping, blood/mucus in stool, bowel urgency, and diarrhea. Disease impact aligned with PROMIS-29 content (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles/activities). Cognitive debriefing indicated that PROMIS-29 instructions were easily understood, items were relevant, and the recall period was appropriate. Psychometric evaluations demonstrated that PROMIS-29 scores indicating worse symptoms/functioning were associated with lower health-related quality of life and greater disease activity and severity. PROMIS-29 domain scores correlated (rs ≥ 0.40) with IBD Questionnaire domains and EuroQol-5-Dimension-5-Level dimensions measuring similar concepts. Test-retest reliability among patients with stable disease was moderate-to-excellent (0.64-0.94) for nearly all domains in all studies. PROMIS-29 was responsive to change in disease status from baseline to week 12. Thresholds for clinically meaningful improvement ranged from ≥3 to ≥8, depending on domain. CONCLUSIONS: PROMIS-29 is valid, reliable, and responsive for assessing general health-related quality of life and treatment response in IBD clinical trials.

Measurement properties of the EQ-5D-Y-3L, PedsQL 4.0, and PROMIS-25 Profile v2.0 in pediatric patients with spinal muscular atrophy.

OBJECTIVE: The objective of this study was to examine the psychometric properties of the EQ-5D-Y-3 L, Patient Reported Outcomes Measurement System 25-item version profile v2.0 (PROMIS-25), and Pediatric Quality of Life Inventory™ version 4.0 Generic Core Scale (PedsQL 4.0) in Chinese pediatric patients with spinal muscular atrophy (SMA). METHODS: The data used in this study were obtained via a web-based cross-sectional survey. Parents of pediatric patients with SMA completed the proxy-reported EQ-5D-Y-3 L, PedsQL 4.0, and PROMIS-25 measures. Information about socioeconomic and health status was also obtained. The ceiling and floor effects, factorial structure, convergent validity, and known-group validity of the three measures were assessed. RESULTS: Three hundred and sixty-three parents of children aged from 5 to 12 completed the questionnaires. Strong floor effects were observed for the physical function components of the PROMIS-25 (41.3%) and PedsQL 4.0 (67.8%). For EQ-5D-Y-3 L, 84.6% of the respondents reported having "a lot of" problems with the dimensions "walking" and "looking after myself." Minimal ceiling or floor effects were observed for the EQ-5D-Y-3 L index value. The confirmatory factor analysis supported a six-factor structure for the PROMIS-25, but did not support a four-factor structure for the PedsQL 4.0. All hypothesized correlations of the dimensions among the three measures were confirmed, with coefficients ranging from 0.28 to 0.68. Analysis of variance showed that EQ-5D-Y-3 L demonstrated better known-group validity than the other two measures in 14 out of 16 comparisons. CONCLUSIONS: The EQ-5D-Y-3 L showed better discriminant power than the other two measures. The physical health dimensions of all three measures showed the significant floor effects. These findings provide valuable insights into the effectiveness of these measures at capturing and quantifying the impact of SMA on patients' health-related quality of life.

Anterior Cruciate Ligament Repair Leads to Improved Patient-Reported Outcomes Compared to Anterior Cruciate Ligament Reconstruction.

Introduction Anterior cruciate ligament (ACL) tears occur frequently in young athletes, and ligament repair and reconstruction are surgical treatments. Although there are suggested benefits for both approaches, there is a lack of direct comparisons between ACL repair and reconstruction.This study aims to compare the mid-term functional outcomes and quality of life measures between patients that have undergone ACL repair versus reconstruction. Methods A retrospective review was conducted for demographic and operative report data of patients who underwent an ACL repair or reconstruction between 2012 and 2018. Patients were contacted over the phone and underwent a Patient-Reported Outcomes Measurement Information System (PROMIS) survey evaluating pain interference, mobility, and function. Patients were excluded from the study if there was an incomplete operative note, missing contact information, or failure to answer phone calls. Results A total of 74 eligible patients were included, with n = 54 in the ACL reconstruction group (73.0%) and n = 20 in the ACL repair group (27.0%). Reconstruction patients had a PROMIS (median (IQR)) physical function score of 22.50 (16.00-59.00), as compared to repair patients' physical function score of 60.00 (21.50-60.00). There was a significant difference favoring repair (p = 0.040). In addition, ACL reconstruction patients had a significantly higher rate of additional procedures, with 63.0% of reconstruction patients receiving an additional operation as compared to 30.0% of repair patients (p = 0.017). The surgery type did not show a significant effect on physical function scores, while additional procedures remained significant in the linear regression analysis. Conclusion Although ACL repair is associated with improved physical function scores as compared to reconstruction in the univariate analysis, surgery type did not show significance when controlling for other variables. Further studies are necessary to compare patients with similar injuries to account for differences in additional procedures, but the results remain promising in assisting with patient-driven treatment decisions.

Translation and linguistic validation of 24 PROMIS item banks into French.

PURPOSE: The Patient-Reported Outcome Measurement Information System (PROMIS®) was developed to provide reliable, valid, and normed item banks to measure health. The item banks provide standardized scores on a common metric allowing for individualized, brief assessment (computerized adaptive tests), short forms (e.g. heart failure specific), or profile assessments (e.g. PROMIS-29). The objective of this study was to translate and linguistically validate 24 PROMIS adult item banks into French and highlight cultural nuances arising during the translation process. METHODS: We used the FACIT translation methodology. Forward translation into French by two native French-speaking translators was followed by reconciliation by a third native French-speaking translator. A native English-speaking translator fluent in French then completed a back translation of the reconciled version from French into English. Three independent reviews by bilingual translators were completed to assess the clarity and consistency of terminology and equivalency across the English source and French translations. Reconciled versions were evaluated in cognitive interviews for conceptual and linguistic equivalence. RESULTS: Twenty-four adult item banks were translated: 12 mental health, 10 physical health, and two social health. Interview data revealed that 577 items of the 590 items translated required no revisions. Conceptual and linguistic differences were evident for 11 items that required iterations to improve conceptual equivalence and two items were revised to accurately reflect the English source. CONCLUSION: French translations of 24 item banks were created for routine clinical use and research. Initial translation supported conceptual equivalence and comprehensibility. Next steps will include validation of the item banks.

The impact of pain on daily activities in patients with idiopathic inflammatory myopathies: Report from the OMERACT myositis working group.

BACKGROUND: International focus groups with patients with idiopathic inflammatory myopathies (IIM) conducted by the OMERACT Myositis Working Group over the years demonstrated the pain as an important symptom experienced by these patients. In this study, we aimed to examine the frequency and degree of pain interference, the aspects of daily life impacted by pain, and the factors associated with pain interference in adults with IIM. METHODS: This was a prospective observational study with two visits. The patients who fulfilled the probable/definite IIM (ACR/EULAR Myositis Classification Criteria) were enrolled. Pain interference was assessed with PROMIS pain interference form (6a). Myositis core set measures and PROMIS fatigue (7a) and physical function (8b) were obtained at both visits. Logistic regression and linear mixed models were performed to assess the association between pain interference and other parameters. RESULTS: A total of 129 patients with IIM (60 % females) were recruited from U.S., South Korea, Netherlands, Sweden, and Australia. Approximately 71 % reported pain interference. The patients in the greater pain interference group were more likely to be female, had significantly worse patient/physician global disease activity, fatigue, and physical function than those in the lower pain interference group. The most commonly impacted life aspect was household chores. Manual muscle testing, patient/physician global disease activity, fatigue, and physical function were all significantly associated with pain interference score >60. CONCLUSION: The majority of the patients with IIM experience the impact of pain on their daily activities, particularly household chores. Myositis disease activity, duration, and subtype could be associated with greater pain interference.

Linking patient-reported oral and general health-related quality of life.

Background: The relationship between oral and overall health is of interest to health care professionals and patients alike. This study investigated the correlation between oral health-related quality of life (OHRQoL) and health-related quality of life (HRQoL) in a general adult population. Methods: This cross-sectional study used a convenience sample of adult participants (N = 607) attending the 2022 Minnesota County and State fairs in USA, the 5-item Oral Health Impact Profile (OHIP-5) assessed OHRQoL, and the 10-item PROMIS v.1.2 Global Health Instrument assessed HRQoL. Spearman and Pearson correlations were used to summarize the bivariable relationship between OHRQoL and HRQoL (both physical and mental health dimensions). A structural equation model determined OHRQoL-HRQoL correlations (r). Correlations' magnitude was interpreted according to Cohen's guidelines (r = 0.10, 0.30, and 0.50 to demarcate "small," "medium," and "large" effects, respectively). Results: OHRQoL and HRQoL correlated with r = 0.52 (95% confidence interval, CI: [0.50-0.55]), indicating that the two constructs shared 27% of their information. According to Cohen, this was a "large" effect. OHRQoL, and the physical and mental HRQoL dimensions correlated with r = 0.55 (95% CI: [0.50-0.59]) and r = 0.43 (95% CI: [0.40-0.46]), respectively, indicating a "large" and a "medium" effect. OHRQoL and HRQoL were substantially correlated in an adult population. Conclusion: Using OHIP-5 to assess their dental patients' oral health impact allows dental professionals to gain insights into patients' overall health-related wellbeing.

Clinical and Radiographic Outcomes Following Volar-Locked Plating Versus Dorsal Bridge Plating for Distal Radius Factures.

Purpose: Distal radius fractures (DRFs) indicated for operative intervention are most commonly treated with volar-locked plating (VLP); however, dorsal bridge plating (DBP) has been used as an alternative fixation method. The purpose of this study was to use a propensity score to match and compare the radiographic and clinical outcomes of patients undergoing isolated VLP or DBP for DRFs. Methods: We performed a retrospective, propensity score-matched analysis of patients undergoing isolated VLP or DBP treatment for isolated DRFs from 2015 to 2022 at a single level-1 trauma center. Patients were propensity score-matched by a total of eight demographic and comorbidity factors, AO Foundation/Orthopedic Trauma Association classification, and preoperative Patient-Reported Outcomes Measurement Information System (PROMIS) scores. Our primary outcomes included postoperative complications, wrist and forearm range of motion (ROM), grip strength, and radiographic measurements, including radial height, radial inclination, volar tilt, and articular step-off. Results: Overall, 415 DBP and 2075 VLP were successfully propensity score-matched and included in this study. Grip strength and ROM measurements at the 6-month follow-up, including wrist flexion, wrist extension, forearm pronation, forearm supination, radial deviation, and ulnar deviation, were increased in the VLP compared with DBP (P < .05). Complication rates among both the groups were relatively low; however, the rates of malunion and nonunion were significantly higher among the DBP group (P < .05). Radial height, radial inclination, and articular step-off were improved in the VLP group compared with the DBP group (P < .05); however, volar tilt was similar between groups. PROMIS upper extremity and physical function were significantly higher among the VLP group (P < .05). No significant difference was noted in PROMIS pain interference between the groups. Conclusions: When compared with DBP, patients undergoing VLP are more likely to have improved clinical and radiographic outcomes. Although improvement in wrist and forearm ROM and radiographic parameters is statistically significant, it may not be clinically relevant. Type of study/level of evidence: Therapeutic III.

Responsiveness and clinically important differences of the PROMIS short form-depression 8a, anxiety 8a, and PASS-20 in individuals with chronic low back pain.

Introduction: Depression and anxiety are the most commonly reported mental health conditions. The Patient-Reported Outcomes Measurement Information System Short Form v1.0-Depression 8a (PROMIS-D-8a), Anxiety 8a (PROMIS-Anx8a), and Pain Anxiety Symptoms Scale-20 (PASS-20) measures were designed to assess depression, general anxiety, and pain-related anxiety, respectively. Objectives: To examine the responsiveness and estimate the clinically important differences (CIDs) of the Thai version of these measures in individuals with chronic low back pain (CLBP). Methods: The study sample comprised 144 participants with CLBP. Responsiveness was evaluated by calculating the change scores, effect sizes (ESs), standardized response means (SRMs), area under the curve (AUC), and correlations between the change scores and associated Global Perceived Effect (GPE). We also estimated CIDs by the difference in mean change score between improved and unchanged groups and standard error of measurement (SEM) for each measure. Results: Statistically significant differences in the mean change scores, ESs, and SRMs supported the responsiveness of all measures. The AUCs achieved acceptable discriminatory ability (0.71-0.72) for moderate improvement but not for any improvement (0.65-0.68). The correlations between GPE and change scores on all measures were low (r ranging 0.28-0.33). The estimated CIDs for the PROMIS-D-8a, PROMIS-Anx8a, and PASS-20 were 3.64, 4.20, and 8.80, respectively. Conclusion: The PROMIS-D-8a, PROMIS-Anx8a, and PASS-20 measures were sensitive for detecting clinical changes over time in individuals with CLBP. The CID values can be used as reference points for assessing meaningful improvements in the domains assessed by these scales in clinical and research practice.

The association between body mass index and physical function in adult burn survivors: A Burn Model System National Database study.

INTRODUCTION: An area of rehabilitation research in burns is the impact of co-morbidities on disease trajectory. Obesity is a comorbidity of increasing public health concern, but its role remains controversial regarding burn injury and physical recovery. Our aim was to evaluate the association between body mass index (BMI) categories as a measure of obesity at discharge and self-reported physical function (PF) during recovery of adult burn survivors. METHODS: This is a retrospective study on data collected by four major US burn centers, which contribute to the Burn Model System National Database. The data included BMI obtained at hospital discharge and self-reported PF-mobility, using the PROMIS measures assessed at 6, 12, and 24 months after burn. Subjects were classified into weight status categories based on BMI: underweight (BMI <18.5), normal weight (18.5 ≤ BMI <25), overweight (25 ≤ BMI <30), obesity class 1 (30 ≤ BMI <35), obesity class 2 (35 ≤ BMI <40), and obesity class 3 (BMI ≥40). Mixed-effects linear regression models were used to assess the association between BMI categories and PF scores over time, adjusted for patient and injury characteristics. RESULTS: A total of 496 adult burn patients aged 47 ± 16 years were included, with mean total body surface area (TBSA) burned of 18 ± 19 % and mean BMI at discharge of 28 ± 7 kg/m2. PROMIS PF scores significantly improved over time in the recovery phase after burn (time effect, p < 0.001). Compared to overweight burn patients, normal-underweights exhibited lower PF score by an average of 4.06 units (p = 0.001) but scores increased linearly by an estimated 0.17 units per month (p = 0.01) over the 24 months after discharge. Similarly, compared to overweight burn patients, class 1 obese reported lower PF score by a mean 2.67 units (p = 0.07) but PF increased linearly by 0.15 units per month (p = 0.07) over the 24 months after discharge. These findings were independent of the effects of age at discharge, sex, TBSA burned, and hand and leg burn. CONCLUSION: Being overweight was associated with improved and faster recovery of PF scores compared to normal, underweight, and obese burn patients during long-term recovery. Hence, our data suggests that long-term recovery and restoration of PF in adult burn survivors is not compromised by a small excess in body weight.

The PAX LC Trial: A Decentralized, Phase 2, Randomized, Double-Blind Study of Nirmatrelvir/Ritonavir Compared with Placebo/Ritonavir for Long COVID.

BACKGROUND: Individuals with long COVID lack evidence-based treatments and have difficulty participating in traditional site-based trials. Our digital, decentralized trial investigates the efficacy and safety of nirmatrelvir/ritonavir, targeting viral persistence as a potential cause of long COVID. METHODS: The PAX LC trial (NCT05668091) is a Phase 2, 1:1 randomized, double-blind, superiority, placebo-controlled trial in 100 community-dwelling, highly symptomatic adult participants with long COVID residing in the 48 contiguous US states to determine the efficacy, safety, and tolerability of 15 days of nirmatrelvir/ritonavir compared with placebo/ritonavir. Participants are recruited via patient groups, cultural ambassadors, and social media platforms. Medical records are reviewed through a platform facilitating participant-mediated data acquisition from electronic health records nationwide. During the drug treatment, participants complete daily digital diaries using a web-based application. Blood draws for eligibility and safety assessments are conducted at or near participants' homes. The study drug is shipped directly to participants' homes. The primary endpoint is the PROMIS-29 Physical Health Summary Score difference between baseline and Day 28, evaluated by a mixed model repeated measure analysis. Secondary endpoints include PROMIS-29 (Mental Health Summary Score and all items), Modified GSQ-30 with supplemental symptoms questionnaire, COVID Core Outcome Measures for Recovery, EQ-5D-5L (Utility Score and all items), PGIS 1 and 2, PGIC 1 and 2, and healthcare utilization. The trial incorporates immunophenotyping to identify long COVID biomarkers and treatment responders. CONCLUSION: The PAX LC trial uses a novel decentralized design and a participant-centric approach to test a 15-day regimen of nirmatrelvir/ritonavir for long COVID.

Effect of fezolinetant on sleep disturbance and impairment during treatment of vasomotor symptoms due to menopause.

OBJECTIVES: To analyse the effect of fezolinetant on patient-reported sleep disturbance and impairment in individuals with vasomotor symptoms (VMS) using pooled data from the SKYLIGHT 1 and 2 studies. STUDY DESIGN: The SKYLIGHT studies were phase-3, double-blind investigations. Individuals (≥40-≤65 years) who were assigned female at birth and seeking treatment of/relief from moderate-to-severe VMS were enrolled. Participants were randomised to receive placebo, fezolinetant 30 mg, or fezolinetant 45 mg during a 12-week treatment period. MAIN OUTCOME MEASURES: Sleep assessments: Patient-Reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b (PROMIS SD SF 8b), PROMIS Sleep-Related Impairment - Short Form 8a (PROMIS SRI SF 8a), and Patient Global Impression of Change/Severity in SD (PGI-C SD and PGI-S SD). Assessments were completed at baseline (except PGI-C SD), weeks 4 and 12. RESULTS: Overall, 1022 individuals were randomised and took ≥1 dose of study drug. PROMIS SD SF 8b results showed that improvements in sleep disturbance were observed for fezolinetant 30 and 45 mg versus placebo (week 12, least squares [LS] mean differences: -0.6 [95 % confidence interval [CI]: -1.7, 0.4] for 30 mg and -1.5 [-2.5, -0.5] for 45 mg). Similar improvements in sleep impairment were reported using the PROMIS SRI SF 8a (week 12, LS mean differences: -1.1 [95 % CI: -2.1, -0.1] for 30 mg and -1.3 [-2.3, -0.3] for 45 mg). For PGI-C SD at week 12, 33.6 % (98/292 participants) of the placebo group felt much/moderately better versus 40.1 % (110/274) and 51.0 % (154/302) of the fezolinetant 30 mg and 45 mg groups, respectively. For PGI-S SD at week 12, 44.0 % (129/293) of the placebo group had severe/moderate problems versus 41.1 % (113/275) and 36.6 % (111/303) of the fezolinetant 30 mg and 45 mg groups, respectively. The 12-week timeframe for this analysis was limited by the length of the placebo-controlled period. CONCLUSIONS: Fezolinetant had a beneficial effect on four measures of sleep disturbance and impairment following treatment for VMS.

Linking QuickDASH and PROMIS Upper-Extremity Computer-Adaptive Test Scores in Hand Surgery: A Crosswalk Study.

PURPOSE: Assessment of patient-reported outcome measures (PROMs) for hand and upper-extremity surgery patients using measures such as the Quick Disabilities of the Arm, Shoulder, and Hand (qDASH), as well as general measures including the Patient-Reported Outcomes Measurement Information System Upper Extremity Physical Function domain via a Computer-Adaptive Test (PROMIS UE CAT), has become commonplace. The aim of this study was to link, for crosswalking, the qDASH measure to both versions of the PROMIS UE CAT (v1.2 and v2.0). METHODS: We included 18,944 hand and upper-extremity patients who completed both versions of the PROMIS UE CAT and the qDASH at the same clinical encounter. Shoulder pathology was excluded. Score linkage was performed using the R package equate, and multiple equating models (linear regression, identity, mean, linear, equipercentile, and circle-arc models) were used to establish crosswalk tables. RESULTS: Mean qDASH and PROMIS UE CAT v1.2 scores were 38.2 (SD = 23.1) and 36.6 (SD = 9.8), respectively. Mean qDASH and PROMIS UE CAT v2.0 scores were 37.3 (SD = 21.8) and 38.3 (SD = 10.4), respectively. Pearson correlations had very strong linear relationships between the qDASH and the PROMIS UE CAT v1.2 and PROMIS UE CAT v2.0 (r = -0.83 [-0.84, -0.92] and r = -0.80 [-0.81, -0.80], respectively). For the equipercentile equating models, the intraclass correlation coefficient (ICC) had very strong positive relationships to linking measures with ICC = 0.85 (0.84, 0.86) for the qDASH-UE CAT v1.2 crosswalk and ICC = 0.83 (0.82, 0.84) for the qDASH-UE CAT v2.0 crosswalk. CONCLUSIONS: The linkages establish crosswalk tables using equipercentile equating models to convert the PROMIS UE CAT v1.2 and v2.0 scores to the qDASH and vice versa. CLINICAL RELEVANCE: This study provides crosswalk tables for commonly collected PROMs in hand surgery, increasing the comparability of results between centers using different PROMs to study the same conditions or treatments.

Preoperative opioid use is associated with worse preoperative patient-reported outcomes in hip arthroscopy patients.

OBJECTIVES: The purpose of this study was to define the rate of preoperative opioid use among patients undergoing hip arthroscopy, ascertain which clinical factors are associated with opioid use, and assess the effect of preoperative opioid usage on preoperative patient-reported outcome (PRO) measures. METHODS: A single institution orthopedic registry was retrospectively analyzed for patients undergoing hip arthroscopy for femoroacetabular impingement (FAI) syndrome with or without labral tear between 2015 and 2022. Patients completed Patient-Reported Outcomes Measurement Information System (PROMIS) in six domains, Numeric Pain Scores (NPS), and Musculoskeletal Outcomes Data Evaluation and Management System expectations domain preoperatively. Patients' charts were reviewed to determine demographic factors and identify any active opioid prescription within 6 weeks before surgery. Bivariate analysis was used to determine associations between preoperative opioid use and baseline PROs. Statistically significant bivariate associations were further tested by multivariate analysis to determine independent predictors. RESULTS: A total of 123 patients were included (age 39.7 â€‹± â€‹12.0 years; 87 females; body mass index 27.4 â€‹± â€‹5.7 kg/m2). There were 21 patients (17%) using opioids preoperatively. Prior orthopedic or other surgery and lower education level were associated with preoperative opioid use. Patients with preoperative opioid use scored statistically significantly worse compared with those without preoperative opioid use on baseline PROMIS Physical Function (38.6 vs 40.5, p â€‹= â€‹0.01), Pain Interference (65.9 vs 60.2, p â€‹= â€‹0.001), Fatigue (60.7 vs 51.6, p â€‹= â€‹0.005), Social Satisfaction (38.2 vs 43.2, p â€‹= â€‹0.007), and Depression (54.2 vs 48.8, p â€‹= â€‹0.01). Preoperative opioid use was also associated with statistically significantly worse preoperative NPS for both the operative hip (6.3 vs 4.6, p â€‹= â€‹0.003) and whole body (3.0 vs 1.4, p â€‹= â€‹0.008). Preoperative opioid use was an independent predictor of worse baseline PROMIS Pain Interference, Fatigue, Social Satisfaction, and NPS for the operative hip. CONCLUSION: Patients using opioids preoperatively had worse baseline PROs for physical function, pain, social satisfaction, and depression than those not using opioids preoperatively. When controlling for confounding variables, preoperative opioid use was independently predictive of worse baseline pain, fatigue, and social satisfaction. LEVEL OF EVIDENCE: Level III, prognostic study.

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.

Extending the PROMIS item bank "ability to participate in social roles and activities": a psychometric evaluation using IRT.

OBJECTIVE: Our objective was to explore whether the extension of the PROMIS item bank Ability to Participate in Social Roles and Activities (APSRA) with new items would result in more effective targeting (i.e., selecting items that are appropriate for each individual's trait level), and more reliable measurements across all latent trait levels. METHODS: A sample of 1,022 Dutch adults completed all 35 items of the original item bank plus 17 new items (in Dutch). The new items presented in this publication have been translated provisionally from Dutch into English for presentation purposes. We evaluated the basic IRT assumptions unidimensionality, local independence, and monotonicity. Furthermore, we examined the item parameters, and assessed differential item functioning (DIF) for sex, education, region, age, and ethnicity. In addition, we compared the test information functions, item parameters, and θ scores, for the original and extended item bank in order to assess whether the measurement range had improved. RESULTS: We found that the extended item bank was compatible with the basic IRT assumptions and showed good reliability. Moreover, the extended item bank improved the measurement in the lower trait range, which is important for reliably assessing functioning in clinical populations (i.e., persons reporting lower levels of participation). CONCLUSION: We extended the PROMIS-APSRA item bank and improved its psychometric quality. Our study contributes to PROMIS measurement innovation, which allows for the addition of new items to existing item banks, without changing the interpretation of the scores and while maintaining the comparability of the scores with other PROMIS instruments.

Socioeconomic Status Correlates With Initial Patient-Reported Outcomes Measurement Information System-Pain Interference (PROMIS-PI) Scores but Not the Likelihood of Spine Surgery.

Objective To explore how socioeconomic status and patient characteristics may be associated with initial self-reports of pain and determine if there was an increased association with undergoing spine surgery. Methods Patients at an academic center between 2015 and 2021 who completed the Patient-Reported Outcomes Measurement Information System-Pain Interference (PROMIS-PI) questionnaire were included. Multivariable linear regression models were used to determine the association between insurance type and patient factors with initial reports of pain. Multivariable logistic regression models were used to determine the association between PI and the likelihood of surgery in two time periods, three and 12 months. Results The study included 9,587 patients. The mean PROMIS-PI scores were 61.93 (SD 7.82) and 63.74 (SD 6.93) in the cervical and lumbar cohorts, respectively. Medicaid and Workers' Compensation insurance patients reported higher pain scores compared to those with private insurance: Medicaid (cervical: 2.77, CI (1.76-3.79), p<0.001; lumbar (2.05, CI (1.52-2.59), p<0.001); Workers' Compensation (cervical: 2.12, CI (0.96-3.27), p<0.001; lumbar: 1.51, CI (0.79-2.23), p<0.001). Black patients reported higher pain compared to White patients (cervical: 1.50, CI (0.44-2.55), p=0.01; lumbar: 1.51, CI (0.94-2.08), p<0.001). Higher PROMIS-PI scores were associated with a higher likelihood of surgery. There was no increased association of likelihood of surgery in Black, Medicaid, or Workers' Compensation patients when controlling for pain severity. Conclusion Black patients and patients with Medicaid and Workers' compensation insurance were likely to report higher pain scores. Higher initial pain scores were associated with an increased likelihood of surgery. However, despite increased pain scores, Black patients and those with Medicaid and Workers' Compensation insurance did not have a higher likelihood of undergoing surgery.