Reported Outcomes Measurement Information System Research Articles

Abstract P239: Impact of American Heart Association/American Stroke Association Online Support Network on Quality of Life

Introduction: Support of patients with cardiovascular (CV) disease and stroke is often associated with improved health-related quality of life (HRQOL). Hypothesis: We assessed the hypothesis that change in patient HRQOL, perception of emotional and informational support, and satisfaction with the American Heart Association/American Stroke Association’s (AHA/ASA) online Support Network (SN) would be observed from before joining the SN to two months after joining the SN. Methods: Using a pre/post-test design, between April 2018 and March 2020, 2,542 adult patients completed a baseline online survey, of whom 412 completed a survey two months later (response rate=16%). Self-report instruments included: Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Questionnaire, Emotional Support (ES), Informational Support (IS), and an AHA/ASA-developed measure of satisfaction with the SN. After converting raw scores into T-scores, linear mixed effects models were used to compare pre and post T-scores. Results: Patients were on average 56± 12.8 years of age, female (63.3%), non-Hispanic White (76.5%), married (58.3%), employed (49.8%), and >high school education (85.0%). 83.5% reported having a CV condition, most commonly hypertension (38.8%), myocardial infarction (31.3%), high cholesterol (31.1%), atrial fibrillation (25.2%); 58.0% reported ≤ 4 co-morbidities. T-scores (mean±SD) did not differ significantly from before to two months after joining the SN: physical health domain (pre=39.2±3.6, post=39.3±3.4) and mental health domain (pre=43.3±9.6, post=44.5±9.7); ES (pre=49.5±9.8, post=49.3±9.8), and IS (pre=49.8±10.3, post=50.5±10.5). At two months, satisfied, neutral, and dissatisfied with SN were 46.3%,44.2%, and 5.1% respectively. 61.5% were likely to recommend the SN to others. Conclusions: In conclusion, HRQOL measures remained stable. Before and after SN participation, physical and mental domain global health scores were lower than the U.S. general population mean of 50, while ES and IS scores approximated the U.S. general population mean. Satisfaction with the SN was moderate with the majority of respondents likely to recommend to others. Future research might explore extending the timeframe to observe change in global health scores.

One-food versus six-food elimination diet therapy for the treatment of eosinophilic oesophagitis: a multicentre, randomised, open-label trial

Empirical elimination diets are effective for achieving histological remission in eosinophilic oesophagitis, but randomised trials comparing diet therapies are lacking. We aimed to compare a six-food elimination diet (6FED) with a one-food elimination diet (1FED) for the treatment of adults with eosinophilic oesophagitis. We conducted a multicentre, randomised, open-label trial across ten sites of the Consortium of Eosinophilic Gastrointestinal Disease Researchers in the USA. Adults aged 18-60 years with active, symptomatic eosinophilic oesophagitis were centrally randomly allocated (1:1; block size of four) to 1FED (animal milk) or 6FED (animal milk, wheat, egg, soy, fish and shellfish, and peanut and tree nuts) for 6 weeks. Randomisation was stratified by age, enrolling site, and gender. The primary endpoint was the proportion of patients with histological remission (peak oesophageal count <15 eosinophils per high-power field [eos/hpf]). Key secondary endpoints were the proportions with complete histological remission (peak count ≤1 eos/hpf) and partial remission (peak counts ≤10 and ≤6 eos/hpf) and changes from baseline in peak eosinophil count and scores on the Eosinophilic Esophagitis Histology Scoring System (EoEHSS), Eosinophilic Esophagitis Endoscopic Reference Score (EREFS), Eosinophilic Esophagitis Activity Index (EEsAI), and quality of life (Adult Eosinophilic Esophagitis Quality-of-Life and Patient Reported Outcome Measurement Information System Global Health questionnaires). Individuals without histological response to 1FED could proceed to 6FED, and those without histological response to 6FED could proceed to swallowed topical fluticasone propionate 880 μg twice per day (with unrestricted diet), for 6 weeks. Histological remission after switching therapy was assessed as a secondary endpoint. Efficacy and safety analyses were done in the intention-to-treat (ITT) population. This trial is registered on ClinicalTrials.gov, NCT02778867, and is completed. Between May 23, 2016, and March 6, 2019, 129 patients (70 [54%] men and 59 [46%] women; mean age 37·0 years [SD 10·3]) were enrolled, randomly assigned to 1FED (n=67) or 6FED (n=62), and included in the ITT population. At 6 weeks, 25 (40%) of 62 patients in the 6FED group had histological remission compared with 23 (34%) of 67 in the 1FED group (difference 6% [95% CI -11 to 23]; p=0·58). We found no significant difference between the groups at stricter thresholds for partial remission (≤10 eos/hpf, difference 7% [-9 to 24], p=0·46; ≤6 eos/hpf, 14% [-0 to 29], p=0·069); the proportion with complete remission was significantly higher in the 6FED group than in the 1FED group (difference 13% [2 to 25]; p=0·031). Peak eosinophil counts decreased in both groups (geometric mean ratio 0·72 [0·43 to 1·20]; p=0·21). For 6FED versus 1FED, mean changes from baseline in EoEHSS (-0·23 vs -0·15; difference -0·08 [-0·21 to 0·05]; p=0·23), EREFS (-1·0 vs -0·6; difference -0·4 [-1·1 to 0·3]; p=0·28), and EEsAI (-8·2 vs -3·0; difference -5·2 [-11·2 to 0·8]; p=0·091) were not significantly different. Changes in quality-of-life scores were small and similar between the groups. No adverse event was observed in more than 5% of patients in either diet group. For patients without histological response to 1FED who proceeded to 6FED, nine (43%) of 21 reached histological remission; for patients without histological response to 6FED who proceeded to fluticasone propionate, nine (82%) of 11 reached histological remission. Histological remission rates and improvements in histological and endoscopic features were similar after 1FED and 6FED in adults with eosinophilic oesophagitis. 6FED had efficacy in just less than half of 1FED non-responders and steroids had efficacy in most 6FED non-responders. Our findings indicate that eliminating animal milk alone is an acceptable initial dietary therapy for eosinophilic oesophagitis. US National Institutes of Health.

A Reduction in Opioid Prescription Size After Total Joint Arthroplasty Can be Safely Performed Without an Increase in Complications

BackgroundExcessive opioid prescriptions after total joint arthroplasty (TJA) increase risks for adverse opioid-related events, chronic opioid use, and unlawful opioid diversion. Decreasing postoperative prescriptions may improve quality after TJA. Concerns exist that a decrease in opioids prescribed may increase complications, such as readmissions, emergency department (ED) visits, or worsened patient-reported outcomes (PROs). The purpose of this study was to explore whether a reduction in opioids prescribed after TJA resulted in increased complications. MethodsData originated from a statewide database prospectively abstracted, including oral morphine equivalents prescribed at discharge, readmissions, ED visits, and PROs. Data were collected from 84,998 TJA occurring 1 year before and after the creation of an opioid-prescribing protocol that had decreased prescriptions by approximately 50%. Trends were monitored using Shewhart control charts. Regression models were used to determine statistically significant changes over time. ResultsAll groups showed a reduction in opioids prescribed by almost 50% without an increase in emergency room visits or readmissions and without a detrimental effect on PROs. Compared to baseline data before opioid reduction, opioid-naive total knee arthroplasty had significant improvements in all outcomes (P = .03, P = .02, P < .001, P < .001). Opioid-tolerant total knee arthroplasty and total hip arthroplasty had no worsened outcomes and significant improvement in (Knee Injury and Osteoarthritis Outcome score for Joint Replacement P = .03) and (Hip Disability and Osteoarthritis Outcome Score for Joint Replacement P = .03). Opioid-naive total hip arthroplasty had significant improvements in Hip Disability and Osteoarthritis Outcome Score Joint Replacement (P = .003) and Patient Reported Outcomes Measurement Information System (P = .001). ConclusionsPostoperative opioid prescription recommendations from a statewide registry decreased prescribing by approximately 50% without decreasing PROs or increasing ED visits or readmissions. A reduction in opioids prescribed after TJA can be accomplished safely and without increased complications.

Impact of Preoperative 12-item Short Form Mental Composite Scores on Clinical Outcomes in Cervical Disc Replacement.

Retrospective cohort study. We aim to examine the effects of preoperative mental health status on demographic, perioperative characteristics, and postoperative outcomes in patients undergoing cervical disc replacement (CDR). The effect of preoperative mental health status has not been widely studied in CDR. Patients undergoing primary CDR were retrospectively collected and stratified into 2 cohorts by 12-item Short Form Survey Mental Composite Score (SF-12 MCS) ≥48.9. Patients without preoperative SF-12 MCS scores or diagnosis of infection, malignancy, or trauma were excluded. Demographic information, perioperative characteristic, and patient reported outcome measures (PROMs) were collected. Patient reported outcome measurement information system physical function (PROMIS-PF)/SF-12 Physical Component Score (PCS)/SF-12 MCS/visual analog scale (VAS) neck/VAS leg/neck disability index (NDI) were collected preoperatively and 6 weeks/12 weeks/6 months/1 year postoperatively. Eighty-seven patients were included, (47 having SF-12 MCS≥48.9). For PROMs, both cohorts had significant improvement from preoperative baseline, besides SF-12 PCS/MCS at 1 year for the depressed cohort and SF-12 MCS at all time points. The non-depressed cohort demonstrated significantly higher PROMIS-PF preoperatively and at 12 weeks, SF-12 PCS at 12 weeks, SF-12 MCS at all time points, decreased VAS neck at 12 weeks and NDI preoperatively and at 12 weeks, overall minimal clinically important difference (MCID) in most patients in all PROMs besides SF-12 MCS, and higher MCID for PROMIS-PF at 12 weeks. The depressed cohort demonstrated overall MCID in most patients with PROMIS-PF/SF-12 MCS/VAS neck/NDI, and a higher MCID for 6 weeks/12 weeks/6 months postoperatively and overall SF-12 PCS. Whereas both cohorts demonstrated significantly improved PROMs from baseline, the non-depressed cohort demonstrated better physical function, mental health, decreased pain, and disability at various time points, whereas the depressed cohort demonstrated higher mental health MCID achievement at every time point except 1 year. These findings may be useful in managing expectations for patients undergoing cervical surgery.

First Metatarsophalangeal Arthrodesis for Hallux Rigidus and Hallux Valgus: A Comparison of Patient Reported and Clinical Outcomes

Few prior studies have compared the patient reported outcomes of first metatarsophalangeal arthrodesis between hallux rigidus and hallux valgus patients. Furthermore, we sought to examine the impact of postoperative radiographic hallux alignment on outcomes scores within each group. A retrospective review of 98 patients who a received primary metatarsophalangeal arthrodesis from January 2010 to March 2020. Clinical complications including nonunion were collected. Patient Reported Outcomes Measurement Information Systems (PROMIS) Physical Function, PROMIS Pain Interference, and the foot function index (FFI) revised short form scores were obtained via telephone. Patients were grouped based on review of preoperative radiographs of the foot and this grouping 37 hallux rigidus and 61 hallux valgus patients. Clinical and patient reported outcomes were compared between these pathologies. No differences in the rate of wound complications, radiographic union, and revision surgery were found between the 2 subgroups. At a median of 2.4 years (3.9 IQR) postoperatively, PROMIS and FFI scores did not vary by pathology group. For both groups, PROMIS scores were similar to the general population of the United States. The postoperative first MTP dorsiflexion angle in the hallux rigidus group was correlated with decreased FFI Pain, FFI Total, and PROMIS Pain Interference domain scores (|r| ≥ 0.40, p < .05 for all). When performing MTP arthrodesis in patients with hallux rigidus, increasing the first MTP dorsiflexion angle may correlate with improved intermediate term patient reported outcomes. However, further studies will need to be done to confirm this theoretical relationship.

Effect of Velopharyngeal Insufficiency on Long-Term Patient-Reported Sleep-Related Impairment in Patients With Cleft Palate

Objective: Velopharyngeal insufficiency (VPI) surgery in patients with cleft palate increases the risk for airway obstruction acutely. However, the long-term effects of VPI surgery on airway obstruction are unknown. In this work, we prospectively evaluated patient-reported sleep-related impairment scores as a screening tool for airway obstruction in patients with cleft palate (CP). Methods: Patients with CP &gt; 14 years of age from 2 institutions were prospectively administered the Patient Reported Outcomes Measurement Information Systems sleep-related impairment short form. Patient characteristics, medical, and surgical histories were reviewed. Multivariable linear regression analyses were performed to assess the contribution of independent variables to sleep-related impairment scores. Results: Forty-four patients (mean age 20.5 ± 4.7 years) were included. Twenty-three patients (52.3%) were diagnosed with VPI. Seventeen patients (38.6%) underwent VPI surgery, of whom 14 patients (82.4%) were treated with sphincter pharyngoplasties at a mean age of 7.7 ± 4.1 years. Multivariable linear regression models to control for variables that could influence sleep-related impairment such as body mass index (BMI) ≥25 were developed to evaluate the contribution of VPI and VPI treatment. The diagnosis of VPI (β = .52, P = .004), VPI surgery (β = .48, P = .008), and sphincter pharyngoplasty (β = .47, P = .011) were found to independently predict sleep-related impairment in each of the respective regression models. Conclusions: A history of VPI, any type of VPI surgery, or sphincter pharyngoplasty were separately and independently predictive of patient-reported sleep-related impairment long-term. These data suggest that longitudinal airway obstruction screening in patients with cleft palate and VPI deserves consideration.

The Mediating Role of Sleep Disturbance on the Association Between Stress and Self-Rated Health Among Chinese and Korean Immigrant Americans.

Disturbed sleep may be a factor that links stress with poor health, especially among groups experiencing high levels of stress caused by racial and ethnic minority and nativity status. The objective of this study was to describe the potential mediating role of sleep disturbance in the associations between various types of stress and self-rated health among Chinese and Korean Americans. Our cross-sectional study consisted of 400 Chinese and Korean immigrants aged 50 to 75 years recruited from August 2018 through June 2020 from physicians' clinics in the Baltimore-Washington, DC, metropolitan area. We used the Patient Reported Outcomes Measurement Information System (PROMIS) short-form questionnaire to measure sleep disturbance. Linear regression analyses examined associations between 3 types of stress (acculturative stress, perceived stress, and distress) and self-rated health, accounting for demographic, socioeconomic, and health insurance factors. The Karlson-Holm-Breen method was used to estimate the total and direct effects of stresses on self-rated health and the indirect effects of stresses on health through sleep disturbance. Greater acculturative stress (β = 0.08; 95% CI, 0.01-0.14), perceived stress (β = 0.05; 95% CI, 0.03-0.08), and distress (β = 0.09; 95% CI, 0.05-0.13) were all associated with poorer self-rated health. Sleep disturbance was a partial mediator, with sleep disturbance accounting for 21.7%, 14.9%, and 18.7% of the associations between acculturative stress, perceived stress, and distress and self-rated health, respectively. Because sleep disturbance partially mediates the associations between stress and poor self-rated health, future interventions and research may consider mitigating sleep disturbances and stress among racial and ethnic minority populations to address health disparities.

Rationale and design of a multisite randomized clinical trial examining an integrated behavioral treatment for veterans with co-occurring chronic pain and opioid use disorder: The pain and opioids integrated treatment in veterans (POSITIVE) trial

BackgroundChronic pain and opioid use disorder (OUD) individually represent a risk to health and well-being. Concerningly, there is evidence that they are frequently co-morbid. While few treatments exist that simultaneously target both conditions, preliminary work has supported the feasibility of an integrated behavioral treatment targeting pain interference and opioid misuse. This treatment combined Acceptance and Commitment Therapy (ACT) and Mindfulness-Based Relapse Prevention (ACT+MBRP). This paper describes the protocol for the adequately powered efficacy study of this integrated treatment. MethodsA multisite randomized controlled trial will examine the efficacy of ACT+MBRP in comparison to a parallel education control condition, focusing on opioid safety and pain education. Participants include veterans (n = 160; 21–75 years old) recruited from three Veterans Administration (VA) Healthcare Systems with chronic pain who are on a stable dose of buprenorphine. Both conditions include twelve weekly 90 min group sessions delivered via telehealth. Primary outcomes include pain interference (Patient Reported Outcome Measurement Information System - Pain Interference) and hazardous opioid use (Current Opioid Misuse Measure), which will be examined at the end of the active treatment phase and through 12 months post-intervention. Secondary analyses will evaluate outcomes including pain intensity, depression, pain-related fear, and substance use, as well as treatment mechanisms. ConclusionThis study will determine the efficacy of an integrated behavioral treatment program for pain interference and hazardous opioid use among veterans with chronic pain and OUD who are prescribed buprenorphine, addressing a critical need for more integrated treatments for chronic pain and OUD. Trial registrationClinicalTrials.gov Identifier: NCT04648228

Physical Activity Habits Among Older Adults Living With Rheumatic Disease.

To describe levels of physical activity (PA) in older adults with rheumatic and musculoskeletal diseases (RMDs) and study the association between PA level and patient-reported outcomes. Using data from FORWARD, a cross-sectional analysis was performed among adults aged 65 years and older with RMDs to assess the levels of PA. PA was categorized as high (vigorously active for at least 30 minutes, 3 times per week), moderate (moderately active for at least 3 times per week) or low (seldom active). We assessed the self-reported levels of PA among patients with different types of RMDs and assessed the association between levels of PA and PROs, including the 29-item Patient Reported Outcomes Measurement Information System (PROMIS-29) assessment. Among the 3343 eligible participants, rheumatoid arthritis (68%) was the most common RMD. High PA was reported by 457 (13.6%) participants, and 1820 (54.4%) reported moderate activity. Overall, participants reported a median of 7 (IQR 0-15) days of moderate to vigorous level of PA for ≥ 30 min per month. Obese participants were significantly more likely to report low levels of activity (44% of obese compared to 25% of nonobese individuals). Participants with low PA levels had higher (worse) pain scores, higher (worse) Health Assessment Questionnaire-Disability Index scores, higher depression rates, and worse PROMIS-29 scores related to pain, sleep and fatigue. Among patients with RMDs, levels of high PA were relatively low among older patients. These observations, though descriptive, support a relationship between physical inactivity and obesity, depression, poor sleep, and fatigue in patients with RMDs.

Physical, Mental, and Social Health of Adult Patients with Sickle Cell Disease after Allogeneic Hematopoietic Stem Cell Transplantation: A Mixed-Methods Study

Patients with sickle cell disease (SCD) experience a considerable physical and psychosocial disease burden. In recent years, the application of allogeneic hematopoietic stem cell transplantation (HSCT) to treat adults with SCD has increased. A thorough understanding of patients' physical, mental, and social health before and after cure is needed to meet the needs of this growing group of patients. We aimed to explore the perspectives of adult SCD patients on the changes in their experienced health and personal life goals after being cured. A mixed-methods approach was used, comprising a semistructured interview and a set of 9 Patient Reported Outcomes Measurement Information System (PROMIS) measures. Adult SCD patients who underwent HSCT at least 1 year earlier were eligible to participate in the study. Interviews were thematically analyzed using MAXQDA software. PROMIS T scores were compared with reference scores of the general population using SPSS Statistics. Ten patients participated in the study; their median age was 29.5 years (range, 19 to 49 years), and their median time since HSCT was 2.7 years (range, 1.0 to 3.5 years). Themes from the interviews were (1) pain/living pain free, (2) physical well-being, (3) mental well-being, (4) perspective/ outlook, (5) education/work, (6) family/friends, and (7) activities/participation. Following the PROMIS framework, we described these themes in a narrative synthesis according to health domain and categorized in 4 chronological time phases: before HSCT, first year post-transplantation, current situation, and future expectations. Physical health improved greatly, but transplantation-related toxicity, ongoing pain from avascular osteonecrosis, and fatigue negatively impacted quality of life in some patients. Furthermore, emotional struggles during the post-transplantation period were common, and patients expressed a need for psychological help. Patients reported improvements in social health and the ability to pursue personal life goals. The mean T scores of all PROMIS measures fell within the normal symptom limits compared with reference data of the general population, although, large variations were observed among the participants, matching our qualitative findings. In general, adult SCD patients experienced improved physical, mental, and social health after cure by HSCT and were able to pursue personal life goals. Yet they found themselves confronted with a new and unfamiliar reality that brought different challenges. Pain due to irreversible avascular osteonecrosis continued to have a negative impact. Clinicians should aim to help patients have realistic expectations before transplantation and offer timely psychological care.

Accuracy of Pain Tolerance Self-assessment Versus Objective Pressure Sensitivity.

Effective treatment of postoperative pain after elective surgery remains elusive, and the experience of pain can be variable for patients. The patient's intrinsic pain tolerance may contribute to this variability. We sought to identify whether there was a correlation between subjective report of intrinsic pain tolerance and objective measurement of pressure dolorimetry (PD). We also sought to identify whether a correlation existed between PD and Patient Reported Outcome Measurement Information System (PROMIS) scores of pain intensity, physical function, and mood. PD is a validated, objective method to assess pain tolerance. Markers of general mental and physical health are correlated with pain sensitization and may also be linked to pain tolerance. PROMIS scores, dolorimetry measurements, and survey data were collected on 40 consecutive orthopaedic foot and ankle surgery patients at the initial clinic visit. Patients were included if they had normal sensation on the plantar foot and no prior surgery or plantar heel source of pain. Objective dolorimetry data reflecting 5/10 pain for the patients were 24 N/cm 2 (±8.9). Patients estimated their pain threshold as 7.3/10 (±2.1). No correlation was found between objective and subjective pain threshold identified. A moderate negative correlation of R = -0.44 was observed regarding PROMIS-M with dolorimetry data ( P < -0.05). PROMIS-M score >60 had a significant decrease in pain threshold to 15.9 ± 8.5 N/cm 2 compared with 25.7 ± 8.9 N/cm 2 for those who were less depressed with a PROMIS<60 ( P < 0.05). Subjective pain tolerance is not correlated with the patient's own objective pain threshold or markers of mental health and should not be used to assist clinical decision making. PROMIS-M is inversely correlated with objective pain. Higher PROMIS-M scores are associated with a lower objective pain threshold. Level II-Lesser Quality Randomized Controlled Trial or Prospective Comparative Study.

Association of Baseline Frailty with Patient-Reported Outcomes in Systemic Lupus Erythematosus at 1 Year.

The relationship of baseline frailty with subsequent patient-reported outcomes in systemic lupus erythematosus (SLE) remains unclear. We assessed these associations in a pilot prospective cohort study. Frailty based on the FRAIL scale and the Fried phenotype and patient-reported outcomes, namely Patient Reported Outcomes Measurement Information System computerized adaptive tests and Valued Life Activities disability, were measured at baseline and 1 year among women aged 18-70 years with SLE enrolled at a single center. Differences in Patient Reported Outcomes Measurement Information System computerized adaptive tests between frail and non-frail participants were evaluated using Wilcoxon rank sum tests, and the association of baseline frailty with self-report disability at 1 year was estimated using linear regression. Of 51 participants, 24% (FRAIL scale) and 16% (Fried phenotype) met criteria for frailty at baseline despite median age of 55.0 and 56.0 years, respectively. Women with (versus without) baseline frailty using either measure had worse 1-year Patient Reported Outcomes Measurement Information System computerized adaptive test scores across multiple domains and greater self-report disability. Baseline frailty was significantly associated with self-report disability at 1 year (FRAIL scale: parameter estimate 0.55, 95% confidence interval (CI) 0.21-0.89, p<0.01; Fried phenotype: parameter estimate 0.61, 95% CI 0.22-1.00, p<0.01), including only slight attenuation after adjustment for SLE cumulative organ damage (FRAIL scale: parameter estimate 0.45, 95% CI 0.09-0.81, p=0.02; Fried phenotype: parameter estimate 0.49, 95% CI 0.09-0.90, p=0.02). These preliminary findings support frailty as an independent risk factor for clinically relevant patient-reported outcomes, including disability onset, among women with SLE.

Correlating the Patient Reported Outcomes Measurement Information System (PROMIS) to the Foot and Ankle Outcome Score and Patient Functional Testing in Total Ankle Arthroplasty Patients

Category: Ankle Arthritis; Other Introduction/ Purpose: The orthopaedic field, including foot and ankle surgery, continues to rely on patient reported outcome measures (PROMs) as the cornerstone of research studies. Various questionnaires exist, each with their advantages and disadvantages. The Patient-Reported Outcomes Measurement Information System (PROMIS) has become increasingly popular due to its reliability, validity, and efficiency. This system has been tested against the Foot and Ankle Outcome Score (FAOS) for foot and ankle conditions, however little is known about its validity for patients with ankle arthritis undergoing total ankle arthroplasty (TAA). Additionally, its relationship to functional tests is unknown, which could reveal whether it could be used in lieu of these resource-intensive assessments. Therefore, we aimed to validate PROMIS against the FAOS and functional tests in TAA patients. Methods: This prospective cohort study included 102 patients (mean age: 63.5 years) who were diagnosed with ankle arthritis and underwent subsequent TAA. Preoperative PROMIS scores, FAOS, and functional tests including the 4 square test (4SST), timed up and go (TUG), and sit-to-stand (STS) were gathered and analyzed preoperatively. PROMIS physical function and pain interference domains were tested for reliability using Rasch partial credit models. Convergent validity between PROMIS physical function and pain interference, and FAOS function, daily living was evaluated using Spearman’s correlation coefficient. In addition, the relationship between the functional tests and all 6 PROMIS domains were evaluated using Spearman’s correlation coefficient. Results: Infit and outfit mean squares (MSQs) for PROMIS physical function ranged from 0.61 – 0.78, indicating a good fit in the Rasch model. Similarly, infit and outfit MSQs for PROMIS pain interference ranged from 0.77 – 0.8, also indicating a good fit. Separation reliability was 0.89 for physical function and 0.85 for pain interference, indicating good reliability to actual patient function and pain levels. PROMIS physical function demonstrated a moderate positive correlation with FAOS function, daily living (r=0.52) while pain interference demonstrated a moderate negative correlation (r=-0.52). PROMIS physical function demonstrated statistically significant weak negative correlations for all 3 functional tests (r=-0.19 for 4SST, r=-0.27 for TUG, r=-0.2 for STS) [Figure 1]. Conclusion: Our study revealed good reliability of PROMIS physical function and pain interference domains, with a moderate correlation to FAOS function, daily living. Additionally, we found weak correlations between PROMIS physical function and functional tests and no significant correlations between pain interference and functional tests. This indicates acceptable convergent validity to the FAOS but not to functional tests. Therefore, while PROMIS provides reliable and valid measures, it does not replace the need for functional tests, which should be pursued in conjunction to deliver a complete assessment of TAA patients.

Risk Factors Associated With Worse Clinical Outcomes of Ankle Fractures Involving the Posterior Malleolus.

Ankle fractures involving the posterior malleolus (PM) tend to result in inferior clinical outcomes compared to other ankle fractures. However, it is unclear which specific risk factors and fracture characteristics are associated with negative outcomes in these fractures. The aim of this study was to identify risk factors for poor postoperative patient-reported outcomes in patients with fractures involving the PM. This retrospective cohort study included patients who sustained ankle fractures involving the PM between March 2016 and July 2020 and had preoperative computed tomography (CT) scans. In total, 122 patients were included for analysis. One patient (0.8%) had an isolated PM fracture, 19 (15.6%) had bimalleolar ankle fractures involving the PM, and 102 (83.6%) had trimalleolar fractures. Fracture characteristics including the Lauge-Hansen (LH) and Haraguchi classifications and posterior malleolar fragment size were collected from preoperative CT scans. Patient Reported Outcome Measurement Information System (PROMIS) scores were collected preoperatively and at a minimum of 1 year postoperatively. The association between various demographic and fracture characteristics with postoperative PROMIS scores was assessed. Involvement of more malleoli was associated with worse PROMIS Physical Function (P = .04), Global Physical Health (P = .04), and Global Mental Health (P < .001), and Depression scores (P = .001). Elevated BMI was also associated with worse PROMIS Physical Function (P = .0025), Pain Interference (P = .0013), and Global Physical Health (P = .012) scores. Time to surgery, fragment size, Haraguchi classification, and LH classification were not associated with PROMIS scores. In this cohort, we found that trimalleolar ankle fractures were associated with inferior PROMIS outcomes compared with bimalleolar ankle fractures involving the PM in multiple domains. Level III, retrospective cohort study.

Relationship between work performance and quality of life in long-term survivors of pediatric and adolescent hematopoietic cell transplant.

To assess work status, missed time at work (absenteeism), work performance (presenteeism), and their relationship with quality of life (QOL) among long-term survivors of childhood hematopoietic cell transplant (HCT). A single-center cross-sectional survey study of adult survivors of childhood allogeneic HCT (performed between 1985 and 2010). Work and QOL data were captured using the World Health Organization Health and Work Performance Questionnaire and the National Institutes of Health Patient Reported Outcomes Measurement Information System (PROMIS), respectively. Higher absenteeism and presenteeism scores meant higher missed time at work and productivity, respectively. PROMIS domains were scored on a T-score metric with a mean score of reference population at 50 and standard deviation of 10. Univariate linear regression was performed to study factors associated with increase in PROMIS scores. Forty-four survivors completed the survey. Median ages at HCT and survey were 11years (interquartile range [IQR] 7-13) and 30years (IQR 26-34), respectively. Seventy-three percent were working, 23% were unemployed, and 4% were students. Employed survivors reported less pain and sleep disturbance. Higher absolute presenteeism was associated with less pain interference and more satisfaction with social roles and activities and physical function. Higher relative presenteeism was associated with less cognitive concerns. We found significant associations between survivors' work status, performance, and QOL. Our findings provide an important insight on the implications of work outcomes on HCT survivors' physical, mental, and social health and emphasize the importance of longitudinal assessment of work status, performance, and QOL.

Nighttime dexmedetomidine for delirium prevention in non-mechanically ventilated patients after cardiac surgery (MINDDS): a single-centre, parallel-arm, randomised, placebo-controlled superiority trial

The delirium-sparing effect of nighttime dexmedetomidine has not been studied after surgery. We hypothesised that a nighttime dose of dexmedetomidine would reduce the incidence of postoperative delirium as compared to placebo. This single-centre, parallel-arm, randomised, placebo-controlled superiority trial evaluated whether a short nighttime dose of intravenous dexmedetomidine (1μg/kg over 40min) would reduce the incidence of postoperative delirium in patients 60 years of age or older undergoing elective cardiac surgery with cardiopulmonary bypass. Patients were randomised to receive dexmedetomidine or placebo in a 1:1 ratio. The primary outcome was delirium on postoperative day one. Secondary outcomes included delirium within three days of surgery, 30-, 90-, and 180-day abbreviated Montreal Cognitive Assessment scores, Patient Reported Outcome Measures Information System quality of life scores, and all-cause mortality. The study was registered as NCT02856594 on ClinicalTrials.gov on August 5, 2016, before the enrolment of any participants. Of 469 patients that underwent randomisation to placebo (n=235) or dexmedetomidine (n=234), 75 met a prespecified drop criterion before the study intervention. Thus, 394 participants (188 dexmedetomidine; 206 placebo) were analysed in the modified intention-to-treat cohort (median age 69 [IQR 64, 74] years; 73.1% male [n=288]; 26·9% female [n=106]). Postoperative delirium status on day one was missing for 30 (7.6%) patients. Among those in whom it could be assessed, the primary outcome occurred in 5 of 175 patients (2.9%) in the dexmedetomidine group and 16 of 189 patients (8.5%) in the placebo group (OR 0.32, 95% CI: 0.10-0.83; P=0.029). A non-significant but higher proportion of participants experienced delirium within three days postoperatively in the placebo group (25/177; 14.1%) compared to the dexmedetomidine group (14/160; 8.8%; OR 0.58; 95% CI, 0.28-1.15). No significant differences between groups were observed in secondary outcomes or safety. Our findings suggested that in elderly cardiac surgery patients with a low baseline risk of postoperative delirium and extubated within 12h of ICU admission, a short nighttime dose of dexmedetomidine decreased the incidence of delirium on postoperative day one. Although non-statistically significant, our findings also suggested a clinical meaningful difference in the three-day incidence of postoperative delirium. National Institute on Aging (R01AG053582).

Normative data of modified romberg balance test for risk of fall in elderly population from Pakistan

Objective: To generate normative data of modified romberg balance test for the risk of fall among the elderly. Method: The crossectional study was conducted from July 1 to December 31, 2021, and comprised healthy adults of either gender aged 60 years and above from different cities of Pakistan. The participants were screened for balance issues using the Patient Reported Outcomes Measurement Information System Global Health Questionnaire. All th eindividuals were subjected to the modified romberg balance test. Data was analysed using SPSS 21. Results: Of the 2004 participants, 1,041(51.95%) were males and 963(48.05%) were females. The overall mean age was 70.36+6.20 years and mean body mass index was 21.92+3.08kg/m2. Overall, 207(10.33%) participants passed all the 4 conditions of the modified romberg balance test. Conclusion: With increasing age, the capability to perform modified romberg balance test decreased, increasing the chance of fall among the elderly. Key Words: Adult, Balance, Fall, Frail older, Musculoskeletal equilibrium.

The Cross-Sectional Association of Sleep Disturbance and Sleep Apnea With Complex Multimorbidity Among Chinese and Korean Americans.

A new concept called complex multimorbidity provides a more reliable measure of disease burden than multimorbidity based on a simple count of diseases, by categorizing diseases according to the body system they affect. This study examined associations between sleep measures and complex multimorbidity among Chinese and Korean Americans in the Baltimore-Washington DC Metropolitan Area, using cross-sectional data (n= 400) from the Screening to Prevent Colorectal Cancer study (2018-2020). Sleep disturbance was measured using the 8-item Patient Reported Outcomes Measurement Information System Sleep Disturbance scale and sleep apnea risk was assessed using the Berlin questionnaire. Complexmultimorbidity was defined as the coexistence of 3 or more of body system disorders assessed by self-report of physician-diagnosed diseases. Poisson regression models with adjustments indicated that individuals with sleep disturbance had 2.15 times the prevalence of having complex multimorbidity (95% confidence interval (CI): 1.07, 4.29). Individuals with a high risk of sleep apnea had 1.19 times the prevalence of having complex multimorbidity(95% CI: 0.47, 3.01). These findings suggest a need for interventions to increase awareness of the importance of sleep among health-care providers and the public and to educate them about causes, signs, and treatment of sleep disturbance and sleep apnea.

Preoperative characteristics are associated with increased likelihood of low early postoperative mobility after adult spinal deformity surgery

BACKGROUND CONTEXTLow early postoperative mobility (LEPOM) has been shown to be associated with increased length of hospital stay, complication rates, and likelihood of nonhome discharge. However, few studies have examined preoperative characteristics associated with LEPOM in adult spinal deformity (ASD) patients. PURPOSETo investigate which preoperative patient characteristics may be associated with LEPOM after ASD surgery. DESIGNRetrospective review. PATIENT SAMPLEIncluded were 86 ASD patients with fusion of ≥5 levels for whom immediate-postoperative AM-PAC Basic Mobility Inpatient Short Form (6-Clicks) scores had been obtained. OUTCOME MEASURESThe primary outcome of this study was the likelihood of LEPOM, defined as an AM-PAC score ≤15, which is associated with inability to stand for more than 1 minute. METHODSSignificant cutoffs for preoperative characteristics associated with LEPOM were determined via threshold linear regression. Multivariable logistic regression was used to assess the impact of preoperative characteristics on the likelihood of LEPOM. RESULTSLEPOM was recorded in 38 patients (44.2%). Threshold regression identified the following cutoffs to be associated with LEPOM: preoperative Patient Reported Outcomes Measurement Information System (PROMIS) scores of ≥68 for Pain, <28.3 for Physical Function, and ≥63.4 for Anxiety; preoperative Oswestry disability index (ODI) score of ≥60; and body mass index (BMI) of ≥35.2. On multivariate analysis, preoperative PROMIS scores of ≥68 for Pain (odds ratio [OR] 5.3, confidence interval [CI] 1.2–22.8, p=.03), <28.3 for Physical Function (OR 10.1, CI 1.8–58.2, p=.01), and ≥63.4 for Anxiety (OR 4.7, CI 1.1–20.8, p=.04); preoperative ODI score ≥60 (OR 38.8, CI 4.0–373.6, p=.002); BMI ≥35.2 (OR 14.2, CI 1.3–160.0, p=.03), and male sex (OR 5.4, CI 1.2–23.7, p=.03) were associated with increased odds of LEPOM. CONCLUSIONSPreoperative PROMIS Pain, Physical Function, and Anxiety scores; ODI score; BMI; and male sex were associated with LEPOM. Several of these characteristics are modifiable risk factors and thus may be candidates for optimization before surgery. LEVEL OF EVIDENCEIII

Understanding Correlation of Electroclinical Findings With Functional and Neuropsychiatric Outcomes in Patients with LGI1-Encephalitis

Objective To evaluate the interplay between seizures, quality of life (QoL), and neuropsychiatric outcomes in patients with leucine-rich glioma-inactived 1 antibody encephalitis (LGI1-Ab-E). Background Patients with LGI1-Ab-E experience varied seizure semiologies, but their potential differing impact on long-term outcomes remains under-explored. Design/Methods We conducted a single-center retrospective cohort study of patients with antibody-confirmed LGI1-Ab-E with seizures. Patients were categorized as having faciobrachial dystonic seizures (FBDS) or non-faciobrachial dystonic seizures (non-FBDS). Patient Health Questionnaire-9 (PHQ-9), Neuro-QoL, Patient Reported Outcomes Measurement Information System (PROMIS), and modified Rankin Scale (mRS) were abstracted. Outcomes were compared using two-tailed independent sample t-tests for continuous variables and chi-square and Fisher's exact test for categorical variables. Change over time was evaluated using Wilcoxon signed-rank test. Results 21 patients (33% female, median 65 years) were included, 10 (47.6%) with FBDS and 11 (53.4%) with non-FBDS. Levetiracetam (66%), lacosamide (42.9%), and valproate (19.0%) were the most common anti-seizure medications; 19 (90.5%) underwent immunotherapy. In patients with at least one year of follow-up, all patients with FBDS (n = 7) and 75% with non-FBDS (n = 6) achieved seizure freedom (p = 0.48). From 8 months to 30 months post-diagnosis, PHQ-9 improved in the FBDS cohort (median 6, IQR 5.5—9.5 to median 2.5, IQR 2.0—4.5, p = 0.06), but remained stable in the non-FBDS cohort (median 5.5, IQR 2.3—9.3 to median 5, IQR 3.0 to 8.0, p = 0.75). Both groups had similar mRS baselines (median mRS 1 for both, p = 0.91) and experienced similar significant mRS worsening at median 23 months post-symptoms onset (median increase 1, p &lt; 0.001 over time). Neuro-QoL and PROMIS scores were similar between groups (for all, p &gt; .05). Conclusions Patients with LGI1-Ab-E who experience exclusively non-FBDS may be at higher risk of sustained depressive symptoms than those with FBDS. Regardless of seizure type, patients with LGI1-Ab-E are at risk for significantly worsening disability despite treatment and seizure freedom.