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Background: Following COVID-19 infection, as many as a third of patients have long-term symptoms, known as post-acute sequelae (PASC). The mechanisms contributing to PASC remain largely unknown and, due to the heterogeneity of symptoms, treating PASC provides unique challenges. Objective: Our study sought to (1) identify clinical symptom profiles based on PROMIS Global Health (GH) items, (2) evaluate demographic and clinical differences across profiles, and (3) identify predictors of change in health-related quality of life (HRQL) over time. Design: This was an observational cohort study of patients with PASC who completed PROMIS-GH between 2/11/21 and 12/3/21 as part of routine care, with data extracted from the electronic health record. Participants: There were 1407 adult patients (mean age 49.6 ± 13.7, 73% female, 81% White race) with PASC seen in the recovery clinic between 2/11/21 and 12/3/21, with 1129 (80.2%) completing PROMIS-GH as routine care. Main Measures: HRQL was measured with PROMIS-GH at initial visit and after 12 months. Key Results: Latent profile analysis identified symptom classes based on five PROMIS-GH items (mental health, ability to carry out physical activities, pain, fatigue, and emotional problems). Four latent profiles were identified: (1) "Poor HRQL" (n = 346), (2) "Mixed HRQL: good mental/poor physical" (n = 232), (3) "Mixed HRQL: poor mental/good physical" (n = 324), and (4) "Good HRQL" (n = 227). Demographics and comorbidities varied significantly across profile with patients with more severe COVID-19 infection more likely to be in profiles 1 and 2. Overall, patients improved 2 T-score points on PROMIS-GH after 12 months, with differences by profile. Predictors of improved HRQL included profile, lower body mass index, and fewer COVID symptoms. Conclusions: Patients with PASC have distinct HRQL symptom profiles which were able to differentiate across COVID-19 severity and symptoms. Improvement over 12 months differed by profile. These profiles may be used to better understand the mechanisms behind PASC. Future research should evaluate their ability to guide treatment decisions to improve HRQL. [ABSTRACT FROM AUTHOR]

Identifying optimal stratification techniques for subgrouping patients with low back pain (LBP) into treatment groups for the purpose of identifying optimal management and improving clinical outcomes is an important area for further research. Our study aimed to compare performance of the STarT Back Tool (SBT) and 3 stratification techniques involving PROMIS domain scores for use in patients presenting to a spine clinic for chronic LBP. Retrospective cohort study. Adult patients with chronic LBP seen in a spine center between November 14, 2018 and May 14, 2019 who completed patient-reported outcomes (PROs) as part of routine care, and were followed up with completed PROs 1 year later. Four stratification techniques, including SBT, and 3 PROMIS-based techniques: the NIH Task Force recommended Impact Stratification Score (ISS), symptom clusters based on latent class analysis (LCA), and SPADE symptom clusters. The 4 stratification techniques were compared according to criterion validity, construct validity, and prognostic utility. For criterion validity, overlap in characterization of mild, moderate, and severe subgroups were compared to SBT, which was considered the gold standard, using quadratic weighted kappa statistic. Construct validity compared techniques' ability to differentiate across disability groups defined by modified Oswestry LBP Disability Questionnaire (MDQ), median days in the past month unable to complete activities of daily living (ADLs), and worker's compensation using standardized mean differences (SMD). Prognostic utility was compared based on the techniques' ability to predict long-term improvement in outcomes, defined as improvement in global health and MDQ at 1-year. There were 2,246 adult patients with chronic LBP included in our study (mean age 61.0 [SD 14.0], 55.0% female, 83.4% white). All stratification techniques resulted in roughly a third of patients grouped into mild, moderate, and severe categories, with ISS and LCA demonstrating substantial agreement with SBT, while SPADE had moderate agreement. Construct validity was met for all techniques, with large effects demonstrated between mild and severe categories for differentiating MDQ, ADLs, and worker's compensation disability groups (SMD range 0.57–2.48). All stratification techniques demonstrated ability to detect improvement by 1-year, with severe groups experiencing the greatest improvement in multivariable logistic regression models. All 4 stratification techniques demonstrated validity and prognostic utility for subgrouping patients with chronic LBP based on risk of long-term disability. ISS and LCA symptom clusters may be the optimal methods given the improved feasibility of including only a few relevant PROMIS domains. Future research should investigate multidisciplinary treatment approaches to target mild, moderate, and severe patients based on these techniques. [ABSTRACT FROM AUTHOR]

Background Debilitating symptoms of recurrent Clostridioides difficile infection (rCDI) often lead to long-term effects on health-related quality-of-life (HRQOL). In ECOSPOR III, SER-109, an investigational oral microbiome therapeutic, was superior to placebo in reducing rCDI. We investigated the validity, reliability, and responsiveness of a 32-item, CDI-specific questionnaire—the Clostridium difficile Quality of Life Survey (Cdiff32)—across mental, physical, and social domains in patients with rCDI. Methods In this post hoc analysis of a phase 3 clinical trial, 182 outpatients with rCDI completed Cdiff32 and EQ-5D at baseline and at 1 and 8 weeks. Cdiff32 was evaluated for item performance, internal reliability, and convergent validity. To assess known-groups validity, Cdiff32 scores were compared by disease recurrence status at week 1; internal responsiveness was evaluated in the nonrecurrent disease group by 8 weeks by means of paired t test. Results All 182 patients (mean age [standard deviation], 65.5 [16.5] years; 59.9% female) completed baseline Cdiff32. Confirmatory factor analysis identified 3 domains (physical, mental, and social relationships) with good item fit. High internal reliability was demonstrated (Cronbach α = 0.94 with all subscales >0.80). Convergent validity was evidenced by significant correlations between Cdiff32 subscales and EQ-5D (r = 0.29–0.37; P <.001). Cdiff32 differentiated patients by disease recurrence status at week 1 (effect sizes, 0.38–0.42; P <.05 overall), with significant improvement from baseline through week 8 in patients with nonrecurrent disease at week 1 (effect sizes, 0.75–1.02; P <.001 overall). Conclusions Cdiff32 is a valid, reliable, and responsive disease-specific HRQOL questionnaire that is fit for purpose for interventional treatment trials. The significant improvement in patients with nonrecurrent disease by 8 weeks demonstrates the negative impact of rCDI on HRQOL. [ABSTRACT FROM AUTHOR]

Purpose: Patient-reported outcome measures (PROMs), including global health and construct-specific measures, are collected across healthcare systems. Efforts should be made to reduce data collection burden and individualize survey administration to patient needs. Our study evaluated the ability of utilizing items on a global health measure to identify patients who may require additional screening. Methods: A cross-sectional study was conducted of patients who completed PROMIS Global Health (GH) as part of routine care, as well as additional construct-specific surveys, in a large healthcare system from 1/1/2016 to 12/31/2018. Receiver operating characteristic (ROC) analysis identified optimal thresholds for PROMIS GH items identifying clinically meaningful thresholds on construct-specific PROMs: PHQ-9 score ≥10, Neuro-QoL Cognitive Function, PROMIS Physical Function, and Satisfaction with Social Roles and Activities T-score ≤40, PROMIS Anxiety, Fatigue, Sleep Disturbance, and Pain Interference T-score ≥60. Results: There were 206,685 patients who completed PROMIS GH and additional construct-specific surveys. Scores ≤3 on PROMIS GH item 10 (emotional problems) had 90.0% sensitivity (area under the curve (AUC) = 0.821) for identifying patients with moderate-severe depressive symptoms on PHQ-9. Similarly high sensitivities and AUCs were demonstrated for PROMIS GH items assessing mental and physical health, fatigue, and pain to identify poor scores on their corresponding construct-specific PROMs. Conclusions: Our study provides preliminary support for the ability of utilizing PROMIS GH items as screening tools to identify patients with poor scores on additional construct-specific PROMs. Through directing construct-specific PROMs to patients for whom they are most applicable, survey burden could be reduced for many patients, allowing a more efficient and targeted use of PROMs in healthcare decision-making. [ABSTRACT FROM AUTHOR]

Introduction/Aims: Riluzole improves survival in amyotrophic lateral sclerosis (ALS), but optimal time and duration of treatment are unknown. The aim of this study was to examine if timing of riluzole initiation and duration of treatment modified its effect on survival. Methods: Patients from the PRO‐ACT dataset with information on ALS Functional Rating Scale, time from onset to enrollment (TFOE), and riluzole use were selected for analysis. Survival from enrollment was the outcome. Multivariable Cox proportional hazard models were examined for interactions between riluzole and TFOE. Inverse probability of treatment weighting (IPTW) was used to assess average treatment effect. Results: Of 4778 patients, 3446 (72.1%) had received riluzole. In unadjusted analyses, riluzole improved median survival significantly (22.6 vs. 20.2 months, log‐rank p < 0.001). In multivariable analyses, no significant interaction between TFOE and riluzole was found. Riluzole effect was uniform during follow‐up. By IPTW, estimated riluzole hazard ratio was 0.798 (95% confidence interval 0.686–0.927). Delaying riluzole initiation by 1 y (6 to 18 months from onset) may translate to reducing median survival from onset by 1.9 months (40.1 to 38.2 months). Discussion: Riluzole appears to reduce risk of death uniformly, regardless of time from onset to treatment, and duration of treatment. Earlier treatment with riluzole may be associated with greater absolute survival gain from onset. Early diagnosis of ALS will facilitate early treatment and is expected to improve survival. [ABSTRACT FROM AUTHOR]

Purpose: The Modified Low Back Pain Disability Questionnaire (MDQ) is a commonly used tool to assess functioning of patients with low back pain (LBP). Recently, the Patient-Reported Outcomes Measurement Information System (PROMIS) was suggested as an alternative platform to assess LBP patient-reported health. We sought to map between the MDQ and PROMIS Physical Function (PROMIS-PF) and Pain Interference (PROMIS-PI) scales using multiple methods.Methods: In a retrospective analysis of LBP patients seen at Cleveland Clinic 11/14/18-12/11/19, T-scores from each PROMIS scale were mapped to MDQ total score individually and together. MDQ item and total scores were mapped to each PROMIS scale. Linear regression as well as linear and equipercentile equating were used. Split sample internal validation using root mean squared error (RMSE), mean absolute error (MAE), and correlations were used to assess accuracy of mapping equations.Results: 13585 patients completed the three scales. In the derivation cohort, average age was 59.0 (SD = 15.8); 53.3% female and 82.9% white. Average MDQ total, PROMIS-PF, and PROMIS-PI T-scores were 40.3 (SD = 19.0), 37.2 (SD = 7.6), and 62.9 (SD = 7.2), respectively. For estimating MDQ total scores, methods that used both PROMIS-PF and PROMIS-PI had closest estimated means, lowest RMSE and MAE, and highest correlations. For estimating each of PROMIS-PF and PROMIS-PI T-scores, the best performing method was equipercentile equating using the MDQ items.Conclusions: We created and internally validated maps between MDQ and PROMIS-PF and PROMIS-PI using linear regression, linear and equipercentile equating. Our equations can be used by researchers wishing to translate scores between these scales. [ABSTRACT FROM AUTHOR]

Post-acute COVID-19 syndrome (PASC) is a global public health crisis in which patients experience lingering and debilitating symptoms beyond 4 weeks after the acute onset of SARS-CoV-2 infection.[1] Sleep disturbance has a reported prevalence of 34-50% in PASC,[2],[3] but only a few studies have identified associated risk factors, and these have primarily described sleep quality and not symptom severity.[3],[4] Likewise, studies to date have not investigated the interaction of mood disorders and fatigue with sleep disturbance severity or the association of objective sleep study indices in PASC. With 58% of PASC patients completing PROMIS Sleep Disturbance, our study may suffer from selection bias. [Extracted from the article]

Background Context: Improving prognostic stratification for patients with low back pain (LBP) outside of a primary care setting has been identified as an important area for further research.Purpose: Our study aimed to identify clinical symptom classes of patients presenting to a spine clinic based on 4 Patient Reported Outcome Measurement Information System (PROMIS) domains and evaluate demographic and clinical differences across classes.Study Design: An observational cross-sectional study of patients seen in spine centers at a large health system.Patient Sample: Adult patients with LBP seen in a spine center between November 14, 2018 and May 14, 2019 who completed patient-reported outcomes as part of routine care.Outcome Measures: PROMIS physical function, pain interference, satisfaction with social roles and activities, and fatigue.Methods: Latent class analysis identified symptom classes based on PROMIS domain scores ≥1 standard deviation worse (meaningfully worse) than the general population. A multivariable multinomial logistic regression model was constructed to evaluate differences in symptom classes based on demographics and socioeconomic characteristics. Lastly, the ability of the profiles to discriminate across levels of disability, based on the modified Oswestry Disability Questionnaire (ODI), was evaluated.Results: There were 7,144 adult patients included in the study who visited spine clinics for a primary complaint of LBP and completed all 4 PROMIS domains (age 58.7±15.9, 54% female). Three distinct classes were identified. Class 1 ("Significant Symptoms," n=3238) had PROMIS scores that were meaningfully worse than the population average for all domains. Class 2 ("Mixed Symptoms," n=1366) had meaningfully worse scores on physical function and pain interference but average scores on other domains. Class 3 ("Mild Symptoms," n=2540) had average scores across all domains. Compared to patients in Class 3, those in Class 2 were more likely older, and those in Classes 1 and 2 were more likely to be divorced, have lower household income, and no employment. Level of disability was significantly different across each class (average (SD) ODI for Classes 1-3: 53.4 (14.3), 39.9 (12.5), 22.9 (12.1), p<.01).Conclusions: Patients presenting to specialty clinics for LBP demonstrate distinct clinical symptom classes which could be utilized to inform specific symptom-based treatment. Future research should evaluate the ability of these classes to predict long-term disability. [ABSTRACT FROM AUTHOR]

Objective The purpose of this study was to test the reliability of the Activity Measure for Post-Acute Care (AM-PAC) "6-Clicks" mobility and activity short forms between patients and therapist proxies. As a secondary aim, reliability was examined when patients completed their self-report before versus after the therapist evaluation. Methods Patients being seen for an initial physical therapist (N = 70) or occupational therapist (N = 71) evaluation in the acute care hospital completed the "6-Clicks" mobility short form (if a physical therapist evaluation) or activity short form (if an occupational therapist evaluation). Whether patients completed their self-assessment before or after the evaluation was randomized. Patient- and therapist-rated "6-Clicks" raw scores were converted to AM-PAC T-scores for comparison. Reliability was assessed with intraclass correlation coefficients (ICCs) and Bland–Altman plots, and agreement was assessed with weighted kappa values. Results The ICCs for the "6-Clicks" mobility and daily activity short forms were 0.57 (95% CI = 0.42–0.69) and 0.45 (95% CI = 0.28–0.59), respectively. For both short forms, reliability was higher when the patient completed the self-assessment after versus before the therapist evaluation (ICC = 0.67, 95% CI = 0.47–0.80 vs ICC = 0.50, 95% CI = 0.26–0.67 for the mobility short form; and ICC = 0.52, 95% CI = 0.29–0.70 vs ICC = 0.34, 95% CI = 0.06–0.56 for the activity short form). Conclusion Reliability of the "6-Clicks" total scores was moderate for both the mobility and activity short forms, though higher for the mobility short form and when patients' self-report occurred after the therapist evaluation. Impact Reliability of the AM-PAC "6-Clicks" short forms is moderate when comparing scores from patients with those of therapists responding as proxies. The short forms are useful for measuring participants' function in the acute care hospital; however, it is critical to recognize limitations in reliability between clinician- and patient-reported AM-PAC scores when evaluating longitudinal change and recovery. [ABSTRACT FROM AUTHOR]

Importance: Long-term health effects have been indicated following COVID-19; however, the impact of COVID-19 on health-related quality of life (HRQOL), including who may experience ongoing symptoms, is unknown. Objective: To identify change in HRQOL following COVID-19 compared to pre-infection HRQOL and a matched control group, and identify predictors of patients who worsen. Design: Retrospective pre-post cohort study with a matched control group. Setting: Large healthcare system in northeast Ohio. Participants: A total of 3,690 adult patients diagnosed with COVID-19 who completed HRQOL surveys during routine care for ambulatory visits before and after infection. Propensity-score 1:1 match was utilized to identify controls without COVID who completed HRQOL at two time points. Main Outcomes: HRQOL was assessed with PROMIS Global Health: global mental and physical health summary scores. Pre- and post-COVID PROMIS Global Health was completed as part of routine care from 1/1/2019 to 2/29/2020 and 4/4/2020 to 11/1/2021, respectively, and extracted from the electronic health record. Results: COVID-19 patients (mean age 53±15; 66% female) completed PROMIS Global Health in the year prior (median 11.1 months) and after diagnosis (median 7.8 months). Compared to before infection, COVID-19 patients had a significant reduction in global mental health and stable global physical health (−0.85 and 0.05 T-score points, respectively) with clinically meaningful reduction (≥5 T-score points) experienced by 27% and 23% of patients, respectively. Predictors of worsening global health included being female, having depression, being hospitalized for COVID-19, and better pre-COVID global health. Compared to the control group, there was significantly worse global mental and physical health decline following COVID-19 (−0.53 and −0.37 T-score points, respectively). Conclusions and Relevance: A quarter of patients with COVID-19 experienced meaningful reductions in HRQOL. Reductions in global mental and physical health were modest, although significantly worse than a control group. Additionally, identified predictors of patients who worsen may assist clinicians when counseling patients of their risk of worse HRQOL following COVID-19. [ABSTRACT FROM AUTHOR]

Objectives: Measures of health-related quality of life (HRQOL) are collected throughout healthcare systems and used in clinical, economic, and outcomes studies to direct patient-centered care and inform health policy. Studies have demonstrated increases in stressors unique to the COVID-19 pandemic, however, their effect on HRQOL is unknown. Our study aimed to assess the change in self-reported global health during the pandemic for patients receiving care in a large healthcare system compared with 1 year earlier.Methods: An observational cross-sectional study of 2 periods was conducted including adult patients who had a healthcare appointment and completed the Patient-Reported Outcomes Measurement Information System Global Health (PROMIS GH) as standard care during the COVID-19 pandemic and a year earlier. The effect of time on PROMIS global mental health (GMH) and global physical health (GPH) was evaluated through multiple statistical methods.Results: There were 38 037 patients (mean age 56.1 ± 16.6 years; 61% female; 87% white) who completed the PROMIS GH during the pandemic (August 2020) and 33 080 (age 56.7 ± 16.5 years; 61% female; 86% white) who had completed it 1 year earlier (August 2019). GMH was significantly worse, whereas GPH was similar during the pandemic compared with a year earlier (adjusted estimate [standard error]: -1.21 (0.08) and 0.11 (0.08) T-score points, respectively).Conclusions: Our study found modest, nonclinically meaningful decreases in GMH and similar GPH during the COVID-19 pandemic compared with a year earlier in patients cared for in a large healthcare system. Nevertheless, healthcare systems are likely seeing a biased sample of patients during these times. Findings from our study have implications for the interpretation of HRQOL during this pandemic. [ABSTRACT FROM AUTHOR]

Background and purpose: There is concern that the Patient Health Questionnaire‐9 (PHQ‐9) depression scale may be impacted by the presence of somatic symptoms (differential item functioning [DIF]) in patients with neurological conditions. We evaluated the PHQ‐9 for the presence and impact of DIF in large clinical samples of neurological patients. Methods: We conducted a cross‐sectional study of patients seen at the Cleveland Clinic Cerebrovascular, Headache, Movement Disorder, and Neuromuscular clinics who completed the PHQ‐9 and patient‐reported disease severity measures as part of standard care between 29 July 2008 and 21 February 2013. We evaluated PHQ‐9 items for DIF with respect to disease‐specific severity for each condition. Salient DIF impact was characterized as a difference between DIF‐adjusted and unadjusted PHQ‐9 scores. Results: Included in the study were 2112 patients with stroke, 8221 with migraine, 440 with amyotrophic lateral sclerosis (ALS), and 5022 with Parkinson disease (PD). Several PHQ‐9 items demonstrated DIF with respect to disease‐specific severity, although salient DIF was present in very few patients (stroke, n = 0; migraine, n = 1; ALS, n = 13; PD, n = 1). Conclusions: PHQ‐9 items function consistently across disease severity, with salient levels of DIF impact found only for a very small proportion of people. These results suggest that the PHQ‐9 provides a consistent measure of depression severity among people with neurological conditions associated with somatic symptoms that overlap with depression. [ABSTRACT FROM AUTHOR]

Purpose: Caregivers, or proxies, often complete patient-reported outcome measures (PROMs) on behalf of patients with stroke. The objective of our study was to assess the validity and responsiveness of proxy-responses compared to patient-responses across multiple domains of health. Methods: Stroke patients and their proxies were recruited to complete PROMs between 7/2018–11/2019. PROMs included Neuro-QoL cognitive function, PROMIS physical function, satisfaction with social roles, anxiety, fatigue, pain interference, sleep disturbance, Global Health, and PHQ-9. Internal consistency and convergent validity were compared between patient- and proxy-reported measures. Known-groups validity was assessed across levels of stroke disability. Internal responsiveness was evaluated using paired t-tests for a subset of patients who attended rehabilitation following stroke. Analyses were stratified by patients ≤ 3 vs > 3 months from stroke. Results: This cross-sectional study included 200 stroke patients (age 62.2 ± 13.3, 41.5% female) and their proxies (age 56.5 ± 13.9, 70% female, 72% spouses). PROMs had high internal consistency and were significantly correlated for patients and proxies. Patient- and proxy-reported measures worsened with increasing stroke disability. For 34 (17%) patients who attended rehabilitation, patients self-reported improvement on 5 domains whereas proxies reported no improvement. Compared to patient self-reports, validity was worse for proxy-reports on patients ≤ 3 months but better > 3 months from stroke. Conclusions: Both patient- and proxy-reported PROMs demonstrated strong validity. Only patient-reported PROMs were responsive to change, and proxies had worse validity for patients ≤ 3 months from stroke but better validity for patients > 3 months from stroke. These findings justify the utilization of proxy responses in stroke patients > 3 months from stroke. [ABSTRACT FROM AUTHOR]

Objectives: Patient-reported outcome measures (PROMs) are increasingly utilized in the evaluation of patients with rheumatic diseases. The aim of our study was to assess the patient experience with completing PROMs within rheumatology clinics, and identify patient characteristics associated with a more positive experience. Methods: We conducted a retrospective cross-sectional study of adult patients seen in rheumatology clinics between 1/1/2017 and 6/30/2017. Patients were included in the study if they completed at least one patient-reported experience question following completion of PROMs. Patient characteristics associated with more positive experiences were identified through multivariable proportional odds models. Results: 12,597 adult patients (mean age 59 ± 15; 76% female; 84% white) completed PROMs, as well as questions on their experience completing PROMs. Patients agreed/strongly agreed that PROM questions were easy to understand (97%), useful (84%), helped their physician understand their health (78%), improved communication with their provider (78%) and improved control over their own care (70%). Predictors of better experience with PROMs included being younger, non-white, having lower income, and being a new patient. Worse self-reported health also predicted better experience with PROMs. Conclusion: Our study found a positive patient experience with PROMs, which is a crucial component of their successful implementation and utilization. Findings from this study suggest PROMs may be particularly beneficial in new patients, minorities, those with lower income, and worse self-reported quality of life. Collecting PROMs could provide opportunities to improve patient–provider communication and enhance control over care for rheumatology patients who could most benefit. [ABSTRACT FROM AUTHOR]

Objective For patients diagnosed with the novel coronavirus, COVID-19, evidence is needed to understand the effect of treatment by physical therapists in the acute hospital on patient outcomes. The primary aims of this study were to examine the relationship of physical therapy visit frequency and duration in the hospital with patients' mobility status at discharge and probability of discharging home. Methods This retrospective study included patients with COVID-19 admitted to any of 11 hospitals in 1 health system. The primary outcome was mobility status at discharge, measured using the Activity Measure for Post-Acute Care 6-Clicks basic mobility (6-Clicks mobility) and the Johns Hopkins Highest Level of Mobility scales. Discharge to home versus to a facility was a secondary outcome. Associations between these outcomes and physical therapy visit frequency or mean duration were tested using multiple linear or modified Poisson regression. Potential moderation of these relationships by particular patient characteristics was examined using interaction terms in subsequent regression models. Results For the 312 patients included, increased physical therapy visit frequency was associated with higher 6-Clicks mobility (b = 3.63; 95% CI, 1.54–5.71) and Johns Hopkins Highest Level of Mobility scores (b = 1.15; 95% CI, 0.37–1.93) at hospital discharge and with increased probability of discharging home (adjusted relative risk = 1.82; 95% CI, 1.25–2.63). Longer mean visit duration was also associated with improved mobility at discharge and the probability of discharging home, though the effects were less pronounced. Few moderation effects were observed. Conclusion Patients with COVID-19 demonstrated improved mobility at hospital discharge and higher probability of discharging home with increased frequency and longer mean duration of physical therapy visits. These associations were not generally moderated by patient characteristics. Impact Physical therapy should be an integral component of care for patients hospitalized due to COVID-19. Providing sufficient physical therapist interventions to improve outcomes must be balanced against protection from viral spread. Lay Summary Patients with COVID-19 can benefit from more frequent and longer physical therapy visits in the hospital. [ABSTRACT FROM AUTHOR]

Self-reported measures of health-related quality of life (HRQOL) are increasingly used in clinical management and evaluation of patient outcomes. HRQOL measures are used to monitor patient progress and treatment response, investigate effects of medical interventions, and provide patient-based data for quality improvement initiatives and policy decisions. Given the importance of HRQOL, it is imperative that the instruments used to assess HRQOL are precise, valid, reliable, and responsive, and that the HRQOL data are appropriately collected, analyzed, and presented. This article reviews the key attributes of studies involving HRQOL data, discusses best practices for selecting appropriate instruments, and provides guidelines for the assessment, analysis, and presentation of these data. A checklist and a reviewer guide are included to serve as templates for authors and reviewers when submitting and reviewing studies involving HRQOL. [ABSTRACT FROM AUTHOR]

Self-reported measures of health-related quality of life (HRQOL) are increasingly used in clinical management and evaluation of patient outcomes. HRQOL measures are used to monitor patient progress and treatment response, investigate effects of medical interventions, and provide patient-based data for quality improvement initiatives and policy decisions. Given the importance of HRQOL, it is imperative that the instruments used to assess HRQOL are precise, valid, reliable, and responsive, and that the HRQOL data are appropriately collected, analyzed, and presented. This article reviews the key attributes of studies involving HRQOL data, discusses best practices for selecting appropriate instruments, and provides guidelines for the assessment, analysis, and presentation of these data. A checklist and a reviewer guide are included to serve as templates for authors and reviewers when submitting and reviewing studies involving HRQOL. [ABSTRACT FROM AUTHOR]

Study Design: Retrospective cohort study.Objective: To (1) confirm validity of Patient-Reported Outcomes Measurement Information System (PROMIS) physical function and pain interference computer-adaptive tests (CATs) and (2) assess the validity of PROMIS Global Health (GH) and five additional PROMIS CATs: social role satisfaction, fatigue, anxiety, depression, and sleep disturbance in a population of patients with chronic low back pain (cLBP) who completed a 3-month Interdisciplinary Pain Program (IPP).Summary Of Background Data: Recent recommendations for assessing outcomes in patients with cLBP have included PROMIS scales; however, there is a need for further evaluation, and PROMIS GH has not been studied in this population.Methods: The study cohort included patients with cLBP who completed the entirety of a 3-month IPP between August 2016 and December 2018. Patient-reported outcome measures (PROMs) were analyzed before the start of the IPP and at graduation. Convergent and discriminant validity were evaluated using Pearson correlation coefficients. Known groups' validity assessed the change in PROMIS scores stratified by improvement on the Modified LBP Disability Questionnaire. Responsiveness was evaluated with standardized response means based on global impression of change.Results: IPP was completed by 217 patients (67.7% women, age 53.8 ± 12.8). Convergent validity was supported (P < 0.01 for all pairwise PROMs comparisons). All PROMs improved significantly by graduation, with the largest improvement for PROMIS pain interference, physical function, social role satisfaction, and Modified LBP Disability Questionnaire. Known groups' validity demonstrated the greatest change on PROMIS physical function, social role satisfaction, pain interference, and depression. Responsiveness was supported for all PROMs in 170 (78.3%) patients who indicated at least minimal improvement (standardized response means 0.43-1.06).Conclusion: Our study provides support of PROMIS CATs, highlights the importance of including other meaningful outcome measures, such as social role satisfaction, and provides the first validation of PROMIS GH, in patients with cLBP. PROMs collection can be streamlined through the use of PROMIS CATs which offer advantages over legacy measures.Level Of Evidence: 3. [ABSTRACT FROM AUTHOR]

Objectives: To estimate the effect of riluzole on the stage-specific risk of progression of ALS. Methods: Patients from the PRO-ACT dataset were staged employing two methods (King's and FT9). Hazard ratios associated with riluzole treatment were estimated for forward transition between stages, using unadjusted and adjusted Markov multistate models. Results: Of 1903 patients, 1587 had received riluzole. Riluzole-treated patients survived non-significantly longer than those who did not (median 22.9 months vs. 18.3 months from time of initial observation, log rank p = 0.16). After adjusting for age and ALSFRS-R slope at first visit, riluzole significantly reduced risk of the following transitions: (1) King's stages: 1->2 (hazard ratio (HR) = 0.81), and 2->3 (HR = 0.82), 4->death (HR = 0.57), and (2) FT9 stages: 1->2 (HR = 0.84), 3->4 (HR = 0.71), and 4->death (HR = 0.67). In contrast, the beneficial effect of riluzole in bulbar-onset patients was in early rather than late King's stages. Conclusions: This examination of cohorts closely followed in clinical trials finds a beneficial effect of riluzole that is predominantly but not exclusively in later stages of ALS. This analytic framework has utility to discern stage-specific treatment effects, and for refined health economic analyses. [ABSTRACT FROM AUTHOR]

Study Design: This is an observational cohort study.Objective: The aim of this study was to compare the effectiveness of PT to an interdisciplinary treatment approach in patients with chronic low back pain (CLBP).Summary Of Background Data: CLBP is a costly and potentially disabling condition. Physical therapy (PT), cognitive behavioral therapy, and interdisciplinary pain programs (IPPs) are superior to usual care. Empirical evidence is lacking to clearly support one treatment approach over another in patients with CLBP.Methods: One hundred seventeen adult patients who completed an IPP for individuals with ≥3 months of back pain were compared to 214 adult patients with similar characteristics who completed PT. The Modified Low Back Pain Disability Questionnaire was the primary outcome measure. Additional measures included: PROMIS physical function, global health, social role satisfaction, pain interference, anxiety, fatigue, sleep disturbance, and Patient Health Questionnaire. Patients who completed the IPP were matched by propensity score to a historical control group of patients who completed a course of PT. Change in functional disability was compared between IPP patients and matched controls. Patient-reported outcome measures were assessed pre to post participation in the IPP using paired t test and by calculating the proportion with clinically meaningful improvement.Results: Propensity score matching generated 81 IPP and 81 PT patients. Patients enrolled in the IPP had significantly greater improvement in MDQ scores upon completion compared to patients in PT (15.8 vs. 7.1, P < 0.001). The majority of IPP patients reached the threshold for clinically meaningful change of ≥10 point reduction (60.5%) compared to 34.6% of PT patients, P < 0.01. Patients in the IPP also showed statistically and clinically significant improvement in social role satisfaction, fatigue, and sleep disturbance.Conclusion: CLBP patients in an IPP demonstrated greater functional improvements compared to similar patients participating in PT.Level Of Evidence: 3. [ABSTRACT FROM AUTHOR]

Background: Mapping Patient-Reported Outcomes Measurement Information System-Global Health (PROMIS-GH) to EuroQol 5-dimension, three-level version (EQ-5D-3L) provides a utility score for use in quality-of-life and cost-effectiveness analyses. In 2009, Revicki et al. mapped the PROMIS-GH items to EQ-5D-3L utilities using linear regression (REVReg). More recently, regression was shown to be ill-suited for mapping to preference-based measures due to regression to the mean. Linear and equipercentile equating are alternative mapping methods that avoid the issue of regression to the mean. Another limitation of the prior models is that ordinal predictors were treated as continuous.Methods: Using data collected from the PROMIS Wave 1 sample, we refit REVReg, treating the PROMIS-GH items as categorical variables (CATReg). We applied linear and equipercentile equating to the REVReg model (REVLE, REVequip) and the CATReg model (CATLE, CATequip). We validated and compared the predictive accuracy of these models in a large sample of neurological patients at a single tertiary-care hospital.Results: In the neurological disease patient sample, CATLE produced the strongest correlations between estimated and observed EQ-5D-3L scores and had the lowest mean squared error. The CATequip model had the lowest mean absolute error and had estimated scores that best matched the overall distribution of observed scores.Conclusions: Using linear and equipercentile equating, we created new models mapping PROMIS-GH items to EQ-5D-3L utility scores. EQ-5D-3L utility scores can be more accurately estimated using our models for use in cost-effectiveness studies or studies examining overall health-related quality of life. [ABSTRACT FROM AUTHOR]

Purpose: Assessment of outcomes from a proxy is often substituted for the patient's self-report when the patient is unable or unwilling to report their status. Research has indicated that proxies over-report symptoms on the patient's behalf. This study aimed to quantify the extent of proxy-introduced bias on the Patient-Reported Outcomes Measurement Information System Global Health (PROMIS GH) scale for mental (GMH) and physical (GPH) scores.Methods: This retrospective cohort study included incident stroke patients seen in a cerebrovascular clinic who completed PROMIS GH between 10/12/15 and 6/6/18. Differential item functioning (DIF) evaluated measurement invariance of patient versus proxy responses. DIF impact was assessed by comparing the initial score to the DIF-adjusted score. Subgroup analyses evaluated DIF within strata of stroke severity, measured by modified Rankin Scale (≤ 1, 2, 3+), and time since stroke (≤ 30, 31-90, > 90 days).Results: Of 1351 stroke patients (age 60.5 ± 14.9, 45.1% female), proxy help completing PROMIS GH was required by 406 patients (30.1%). Proxies indicated significantly worse response to all items. No items for GMH or GPH were identified as having meaningful DIF. In subgroup analyses, no DIF was found by severity or 31-90 days post-stroke. In patients within 30 and > 90 days of stroke, DIF was detected for 2 items. Accounting for DIF had negligible effects on scores.Conclusions: Our findings revealed the overestimation of symptoms by proxies is a real difference and not the result of measurement non-invariance. PROMIS GH items do not perform differently or have spuriously inflated severity estimates when administered to proxies instead of patients. [ABSTRACT FROM AUTHOR]

Objectives: Propose an empirical amyotrophic lateral sclerosis (ALS) staging approach called Fine'til 9 (FT9) based on how many of the patient's ALS functional rating scale (ALSFRS-R) subscores are 9 or less (of normal 12). Gain insights into progression of ALS by applying Markov models to ALS stages by multiple systems (King's, Milan-Torino system (MITOS) and FT9). Methods: Patients from the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) dataset were staged using ALSFRS-R responses. Risks of progression through stages and death were estimated, as were effects of prognostic variables on these risks. Results: A total of 29,947 time points in 3199 patients from the PRO-ACT dataset were assigned stages. Although the three systems were moderately correlated, MITOS stages were heavily skewed toward advanced disease, whereas King's and FT9 stages were more balanced. Non-sequential progression was observed with King's system. Markov models adequately described transitions from stage to stage in the first year of observation, but underestimated risks beyond that point. Regardless of staging method, initial rate of ALSFRS-R decline had a powerful effect on rate of progression through sequential stages, whereas age predominantly influenced stage-specific mortality. Conclusion: King's and FT9 are more sensitive to observed progression of disease in clinical trials than MITOS. FT9 can partition the course similar to King's, and may have advantages of sequential progression and easy applicability to retrospective data. Markov transition intensity estimates may be of value for counseling, health economic studies, and research design. In particular, this framework permits estimation of multidimensional effects of variables (including treatment) on outcome. [ABSTRACT FROM AUTHOR]

Objectives: To examine the accuracy of general health cross-walk tables in a clinical sample of patients with spine disorders. Published tables (Schalet BD, Rothrock NE, Hays RD, et al. Linking physical and mental health summary scores from the Veterans RAND 12-Item Health Survey (VR-12) to the PROMIS(®) Global Health Scale. J Gen Intern Med 2015;30:1524-30) link scores from the Veterans RAND 12-Item Health Survey (VR-12) to the 10-Item Patient-Reported Outcome Measurement Information System (PROMIS), a global health scale metric for both mental (GMH) and physical (GPH) summary scores.Methods: We assessed the accuracy of administered PROMIS and VR-12 scores with scores predicted by cross-walks in 4606 adult patients seen in a spine clinic from October 2015 to 2016. Accuracy of linking scores was evaluated using Pearson correlation, intraclass correlation coefficients, and mean and SD of score differences. Bland-Altman plots were used to graphically assess the levels of agreement. The consistency in scores' discrimination across levels of pain severity, depression, and other patient characteristics was assessed. Bootstrap methods estimated linking precision across varying sample sizes.Results: Actual and cross-walked PROMIS scores showed moderate correlation (ICC(3,1): GMH 0.73; GPH 0.81), with Bland-Altman plots suggesting smaller differences between scores in patients with lower and higher general health. Significant discrimination between patient subgroups was demonstrated reliably by both actual and estimated scores. Bootstrapped resamples indicated adequate precision for 200 patients (95% confidence interval for mean difference: GMH -1.38 to 0.60; GPH 0.39 to 1.93).Conclusions: VR-12 and PROMIS global health scores can be accurately linked within a sample of patients with spine disorders; nevertheless, bias is high and precision is low for linking on the patient level. Linked scores at the group level for more than 200 patients can be used in comparative effectiveness research and for comparing results across studies. [ABSTRACT FROM AUTHOR]

Background: Home‐based primary care promotes aging in place but is not immediately responsive to urgent needs. Community paramedicine leverages emergency medical services clinicians to expedite in‐home care, though limited evidence supports this model. We evaluated the primary care and acute care use of older adults evaluated urgently by a community paramedic with telemedicine physician compared to a physician home visit model. Methods: This prospective cohort study enrolled older adults in home‐based primary care who requested an urgent evaluation. We allocated participants to the physician home visit model or physician home visit plus community paramedic model by ZIP code. We observed primary care and acute care use for 6 months following enrollment. The primary outcome was the median number of primary care and acute care visits per participant. Secondary outcomes included 30‐day readmission rates, median wait times, and physician productivity. Data analysis included descriptive statistics, comparison of means and proportions, and negative binomial regression modeling reported as incidence rate ratios (IRR). Results: We screened 255 participants, determined 203 eligible, allocated 199, and completed observation for 167 (84 community paramedicine, 83 physician home visit). Participants were mostly female, age 76–86 years, with 3–5 comorbidities, living in a home/apartment. Community paramedic participants had 29% more primary care visits (IRR 1.29, 95% confidence interval [CI] 1.06–1.57) and shorter wait times for urgent evaluations (1 vs. 5 days, p < 0.001) without increasing acute care use (IRR 0.75, 95% CI 0.48–1.18) or 30‐day readmissions (IRR 1.32, 95% CI 0.49–3.55). Physician productivity increased 81% (40 vs. 22 visits/week, p < 0.001). Conclusion: Older adults evaluated by a community paramedic for urgent needs were seen sooner, used acute care similarly to patients evaluated by a physician home visit, and nearly doubled physician efficiency. This suggests that older adults may benefit from combining emergency medical services and primary care resources for urgent evaluations. [ABSTRACT FROM AUTHOR]

The SF-36 is a generic measure to assess health-related quality of life (HRQOL); whereas the MSIS-29 is a condition-specific PROM evaluating perceived physical and psychological impact of Multiple sclerosis (MS). Clinical trials and regulatory agencies historically have focused on clinical outcomes including clinician-rated disability measures, biomarkers, and imaging. The MSIS-29 and SF-36 as outcomes in secondary progressive MS trials. [Extracted from the article]

Introduction: Rate of decline of the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) score is a common outcome measure and a powerful predictor of mortality in ALS.Methods: Observed rate of decline (postslope) of ALSFRS-R, its linearity, and its relationship to decline at first visit (preslope) were examined in the Pooled Resource Open-Access ALS Clinical Trials cohort by using longitudinal mixed effects models.Results: Mean ALSFRS-R postslope in 3,367 patients was -0.99 points/month. Preslope and postslope were correlated and had powerful effects on survival. ALSFRS-R trajectories were slightly accelerated overall, but slope and direction/degree of curvature varied. Subscore decline was sequential by site of onset. Respiratory subscore decline was the least steep.Discussion: Variable curvilinearity of ALSFRS-R trajectories confounds interpretation in clinical studies that assume linear decline. Subscore trajectories recapitulate phenotypic diversity and topographical progression of ALS. ALSFRS-R is better used as a multidimensional measure. Muscle Nerve 57: 937-945, 2018. [ABSTRACT FROM AUTHOR]

Objective Subjective cognitive complaints are a frequent concern of patients with epilepsy. The Aldenkamp–Baker Neuropsychological Assessment Schedule (ABNAS) is a patient-reported scale validated to measure adverse cognitive effects of antiepileptic drugs (AEDs). The goals of this study were to identify predictors of patient-reported cognitive dysfunction and to assess the relationship between subjective and objective cognitive impairment. Methods The Cleveland Clinic Knowledge Program Data Registry was used to identify adult patients seen in outpatient epilepsy clinic from January to May 2015 and who completed the following scales: ABNAS for subjective cognitive impairment, Patient Health Questionnaire (PHQ-9) for depression, Generalized Anxiety Disorder 7-item (GAD-7) scale, Quality of Life in Epilepsy (QOLIE-10), and EuroQOL five dimensions questionnaire (EQ-5D) for health-related quality of life. Topiramate (TPM) was considered a high-risk medication for cognitive impairment. Patients were categorized into groups based on total ABNAS score: subjective cognitive impairment (ABNAS > 15; N = 270) and no subjective cognitive impairment (ABNAS ≤ 15; N = 400). Multivariable logistic regression models were constructed to identify independent predictors of subjective cognitive impairment. In a subset of patients who had neuropsychological testing within 6 months of completing the ABNAS (N = 60), Pearson correlations and multivariable logistic regression models, controlling for number of AEDs, depression, and anxiety, assessed the relationship between subjective cognitive impairment and objective cognitive performance on measures of intelligence, attention/working memory, verbal fluency, naming, processing speed, manual dexterity, visuomotor processing, and verbal memory. Results Forty percent of patients in the overall sample (N = 270/670) reported cognitive impairment. The variables most strongly associated with subjective cognitive impairment were PHQ-9 score, number of AEDs, and seizure frequency. In the subset of patients with neuropsychological testing, ABNAS score was correlated with anxiety (r = 0.44), depression (r = 0.38), and attention/working memory (r = − 0.31). After adjusting for depression and anxiety, patients who endorsed subjective cognitive impairment scored significantly lower on measures of nonverbal intelligence and attention/working memory, but not on other cognitive measures. Conclusions Subjective cognitive impairment as reported on the ABNAS is most strongly associated with depressive symptomatology, number of AEDs, and seizure frequency, but not with most objective cognitive measures. Identifying these three predictors provides a clear framework to understand and address subjective cognitive complaints in adult patients with epilepsy. [ABSTRACT FROM AUTHOR]

Introduction: With the increasing adoption of peroral endoscopic myotomy (POEM) as a first-line therapy for achalasia as well as a growing list of other indications, it is apparent that there is a need for effective training methods for both endoscopists in training and those already in practice. We present a hands-on-focused with pre- and post-testing methodology to teach these skills.Methods: Six POEM courses were taught by 11 experienced POEM endoscopists at two independent simulation laboratories. The training curriculum included a pre-training test, lectures and discussion, mentored hands-on instruction using live porcine and ex-plant models, and a post-training test. The scoring sheet for the pre- and post-tests assessed the POEM performance with a Likert-like scale measuring equipment setup, mucosotomy creation, endoscope navigation, visualization, myotomy, and closure. Participants were stratified by their experience with upper-GI endoscopy (Novices <100 cases vs. Experts ≥100 cases), and their data were analyzed and compared.Results: Sixty-five participants with varying degrees of experience in upper-GI endoscopy and laparoscopic achalasia cases completed the training curriculum. Participants improved knowledge scores from 69.7 ± 17.1 (pre-test) to 87.7 ± 10.8 (post-test) (p < 0.01). POEM performance increased from 15.1 ± 5.1 to 25.0 ± 5.5 (out of 30) (p < 0.01) with the greatest gains in mucosotomy [1.7-4.4 (out of 5), p < 0.01] and equipment (3.4-4.7, p < 0.01). Novices had significantly lower pre-test scores compared with Experts in upper-GI endoscopy (overall pre-score: 11.9 ± 5.6 vs. 16.3 ± 4.6, p < 0.01). Both groups improved significantly after the course, and there were no differences in post-test scores (overall post-score: 23.9 ± 6.6 vs. 25.4 ± 5.1, p = 0.34) between Novices and Experts.Conclusions: A multimodal curriculum with procedural practice was an effective curricular design for teaching POEM to practitioners. The curriculum was specifically helpful for training surgeons with less upper-GI endoscopy experience. [ABSTRACT FROM AUTHOR]

Background: Approximately 20-30 % of morbidly obese patients undergoing Roux-en-Y gastric bypass (RYGB) will experience significant weight regain in the years following surgery. Endoscopic gastrojejunal revision (EGJR) has been shown to be a safe, effective and less invasive alternative to revisional surgery, with promising weight loss outcomes. However, minimal data exist regarding how to perform the procedure most effectively and what factors may predict good outcomes. We compared weight loss outcomes between patients undergoing endoscopic stoma revision by one of two full-thickness suturing techniques.Methods: A retrospective review of patients undergoing EGJR between 06/2012 and 09/2015 was performed. Included patients were adults 18-74 years of age who had experienced weight regain ≥2 years after initial RYGB with stoma dilation ≥15 mm in diameter. Revision was done with either an interrupted (IRT) or purse-string (PST) suture technique. A linear mixed effects model was constructed to predict postoperative weight loss.Results: Fifty revisions (IRT = 36, PST = 14) were performed in 47 patients (92 % female, mean age of 50.9 ± 10.9 years and body mass index of 41.4 ± 7.1 kg/m2). Technical success (stoma diameter ≤10 mm) was achieved in all cases. Final diameter was significantly smaller in the PST group, 6.6 ± 2.2 mm versus 4.8 ± 1.8 mm (p < 0.01), resulting in a significantly greater % stoma reduction (76.8 ± 8.5 % vs. 84.2 ± 5.1 %, p < 0.01) versus the IRT group. PST resulted in greater % excess weight loss over time compared to IRT. Sixteen comorbid conditions resolved among 12 patients. No major complications occurred.Conclusion: Endoscopic revision of the gastric outlet results in meaningful weight loss and comorbidity resolution in select patients experiencing weight regain following RYGB. A PST revision likely results in higher and more sustainable weight loss when compared to IRT. [ABSTRACT FROM AUTHOR]

Background: Laparoscopic inguinal hernia repair has been shown to offer patients the benefit of less postoperative pain as compared to traditional open techniques. However, the risk of experiencing significant postoperative pain may affect patient's decision making. We aimed to elucidate potential patterns of pain and the predictors of such, up to 2 years postoperatively, using both generic and specific quality of life tools.Methods: Patients undergoing laparoscopic totally extra-peritoneal inguinal hernia repair were identified from a prospectively maintained database. Short form-36, Surgical Outcomes Measurement System (SOMS) and Carolinas Comfort Scale (CCS) surveys were administered pre- and postoperatively at 3 weeks, 6 months, 1 and 2 years. Patients with concomitant procedures were excluded. Significant pain was considered mild but bothersome or worse on either specific tool (SOMS scores ≥3/4, CCS scores ≥2). Predictors of significant pain were determined by logistic regression.Results: From 2009 to 2015, 482 patients enrolled in our database underwent elective TEP repair of 626 hernias and completed an assessment tool. Mean age was 57 (±15) years, with 93 % male. Reported pain on all three tools improved significantly from baseline over time (p < 0.01). Significant pain on either specific tool, related or unrelated to surgery, was reported by 52 % of respondents (158/301) preoperatively, and postoperatively by 50 % at 3 weeks (111/220), 21 % at 6 months (15/70), 13 % at 1 year (14/108), and 25 % at 2 years (30/121). Significant pain at 6 months-2 years correlated more significantly with general health status than surgical factors.Conclusions: Significant pain can be as high as 50 % at 3 weeks on surgery-specific quality of life measures, but with significant improvement by 6 months which is maintained through 2 years. Poor quality of life and general health were the main predictors of pain after 6 months. [ABSTRACT FROM AUTHOR]

Objective: To determine the extent to which low testosterone levels impact health-related quality of life in patients undergoing active surveillance (AS) for prostate cancer.Materials and Methods: Eligible AS patients were grouped as having low, low-normal, or normal testosterone levels (<300 vs 300-400 vs ≥400 ng/dL). Patients were surveyed with the Expanded Prostate Cancer Index Composite-26 (EPIC-26), Patient Reported Outcomes Measurement Information System (PROMIS), Memorial Anxiety Scale for Prostate Cancer, and treatment outlook satisfaction questions at enrollment and successively during follow-up.Results: The cohort consisted of 223 patients, 74 (33%) of which had low testosterone levels. The mean age was 66.8 ± 7.2 years, with 85% being Caucasian. Mean prostate-specific antigen did not differ between groups. Obesity was significantly higher for men with low testosterone levels (P < .01). All PROMIS-Global items were comparatively lower in men with lower testosterone. EPIC-26 scores for the sexual domain were worse in men with lower testosterone. After age and obesity adjustment, men with normal testosterone levels had significantly better PROMIS Physical, Overall, and Mental Health, EPIC-26 Hormonal, and treatment satisfaction responses when compared to those patients with low testosterone levels. Those with normal testosterone levels reported hormonal EPIC-26 domain responses 65% higher than for those with low testosterone, and 12% higher treatment satisfaction during 2-year follow-up when corrected for age and obesity (P < .05).Conclusion: Men with testosterone levels ≥400 ng/dL reported some improved measures of health-related quality of life including greater satisfaction with treatment outcome. These findings are hypothesis generating in the controversial area of exogenous testosterone administration in men on AS. [ABSTRACT FROM AUTHOR]

Despite declining physical function, individuals with ALS report relative preservation of overall health perception, or health-related quality of life (HRQoL). This paradoxical finding is attributed to psychological adaptation to deficits. The aim of this cross-sectional study was to examine reprioritization of factors that determine HRQoL with disease progression. As standard care, patients with ALS self-reported ALSFRS-R (measure of bulbar, motor, and respiratory function), PHQ-9 (measure of depression), and EQ-5D-3L (utility index that includes a visual analog scale asking about health perception [EQ-VAS]). ALS was staged by the FT9 method and classified into early (stages 0–2) and late (stages 3–4) disease. Multigroup structural equation modeling was used to evaluate weights of physical (PHY) and psychological well-being (PSY) for early and late disease, on EQ-VAS (as a measure of overall HRQoL). There were 578 patients (mean age 61.5 ± 11.9, 59% male) with ALS: 423 (73%) early and 155 (27%) late disease. A measurement model was established with good model fit (RMSEA = 0.076, CFI = 0.943, SRMR = 0.045). In adjusted models, standardized weights of PHY and PSY on HRQoL in early disease were 0.34 (standard error = 0.06) and 0.24 (0.06) respectively, whereas for late disease they were 0.39 (0.07) and 0.42 (0.07). Importantly, PHY and PSY were significantly correlated in early but not in late disease. Our study found health perception is more representative of psychological well-being and less representative of physical function across the disease progression. Greater allocation for psychological health would be the most effective strategy to maximize subjective health status as ALS advances. [ABSTRACT FROM AUTHOR]

Purpose Many unintended pregnancies occur due to to contraceptive misuse and nonuse, which is partly due to to lack of knowledge and low self-efficacy related to contraception. We conducted an exploratory, cross-sectional study among low-income women to examine the relationship between knowledge, skills, and confidence in managing one's health, measured using the Patient Activation Measure (PAM) and factors that influence contraceptive use. Methods A survey and chart review were conducted among 18- to 45-year-old women from a community health center in Chicago, Illinois, to measure the relationship between activation, self-confidence in avoiding pregnancy, contraception use, and contraceptive counseling. Associations between PAM and outcomes were evaluated using the χ 2 test and adjusted logistic regression models. Results Among 112 participants (61% Latina, 15% Black, 14% White), we found no differences in PAM by age, race/ethnicity, or parity. Women with higher PAM were more likely to be confident they could avoid pregnancy compared with women with lower PAM (50% vs. 7%; p = .02). Higher PAM remained a significant predictor for self-confidence after risk adjustment (odds ratio, 3.13; 95% CI, 1.11–8.78; p = .031). Greater confidence in avoiding pregnancy was associated with using a moderately or highly effective contraceptive method (43% vs. 14%; p = .047). Women with lower PAM were less likely to receive contraceptive counseling in the prior month (0% vs. 57%; p < .01). Conclusions Patient activation may be an important construct for understanding factors that influence women's contraceptive use, including self-confidence in avoiding pregnancy until it is desired and receiving contraceptive services in primary care. [ABSTRACT FROM AUTHOR]

Background Associations have been documented recently between some of the 23 single nucleotide polymorphisms newly discovered with the Collaborative Oncological Gene-environment Study iCOGS array that indicate prostate cancer (PCa) risk and aspects of disease aggressiveness. The utility of these iCOGS SNPs remains to be determined in active surveillance (AS). Objective To determine associations between iCOGS SNPs and upgrading among men who underwent surgical treatment and AS for low-risk PCa. Design, setting, and participants The genotypes of the 23 iCOGS SNPs were determined for all white subjects with biopsy Gleason score (GS) 6 including 950 men who underwent definitive treatment with surgery and 209 men who elected AS. The clinical and pathologic characteristics were documented for all subjects. Outcome measures and statistical analysis Men who underwent surgery were grouped according to their pathologic GS (upgraded was defined as GS ≥7; nonupgraded remained GS 6). Men who were enrolled in AS were also grouped according to their GS on subsequent surveillance biopsies. Statistical analyses were performed comparing the genotypes between the upgraded and nonupgraded groups. Results and limitations Overall, 31% and 34% of men were upgraded in the surgery and AS cohorts, respectively. Three iCOGS SNPs were significantly associated with the risk of upgrading in the surgical cohort. After correction for multiple testing, only rs11568818 on chromosome 11q22 remained significantly associated with upgrading. Assessment of this allele in the AS cohort reveals that it was present at noteworthy higher frequencies in men with high-grade disease on surveillance biopsies compared with nonupgraded men ( p = 0.003). This study was primarily limited by the homogeneous patient population. Conclusions This is the first report of a SNP on chromosome 11q22 associated with higher grade disease in a surgical cohort that is also validated for eventual upgrading in a prospective AS cohort. Patient summary We examined the relationship between a group of genetic markers and prostate cancer (PCa) aggressiveness in a group of patients who underwent surgery for PCa and a group of patients who were enrolled in active surveillance. We found that these genetic markers helped predict which patients had more aggressive disease in both groups. [ABSTRACT FROM AUTHOR]

Background: It is unknown whether acid/reflux control prevents progression in Barrett's esophagus. In this study, we investigate whether medical or surgical control of reflux is associated with a decreased risk of progression to dysplasia/esophageal adenocarcinoma.Methods: We retrospectively collected and analyzed data from a cohort of Barrett's esophagus patients participating in this single-center study comprised of all patients diagnosed with Barrett's esophagus at NorthShore University Health System hospitals and clinics over a 10-year period. Patients were followed in order to identify those progressing from Barrett's esophagus to low-grade dysplasia, high-grade dysplasia, and esophageal adenocarcinoma. We collected information from the patient's electronic medical records regarding demographic, endoscopic findings, histological findings, smoking/alcohol history, medication use including proton-pump inhibitors, and history of bariatric and antireflux surgery. Risk-adjusted modeling was performed using multivariable logistic regression.Results: This study included 1,830 total Barrett's esophagus patients, 102 of which had their Barrett's esophagus progress to low-grade dysplasia, high-grade dysplasia, or esophageal adenocarcinoma (confirmed by biopsy) with an annual incidence rate of 1.1%. Mean follow-up period was 5.51 years (10,083 patient-years). Compared to the group that did not progress, the group that progressed was older (69.3 ± 13.7 vs. 63.9 ± 13.4 years. p < 0.001) and likely to be male (75 vs. 61%, p < 0.01). In the multivariable analysis, patients who had a history of antireflux surgery (n = 44) or proton-pump inhibitor use without surgery (n = 1,641) were found to progress at significantly lower rates than patients who did not have antireflux surgery or were not taking PPI's (OR 0.18, 95% CI 0.09-0.36).Conclusions: Reflux control was associated with decreased risk of progression to low-grade dysplasia, high-grade dysplasia, or esophageal adenocarcinoma. These results support the use of reflux control strategies such as proton-pump inhibitor therapy or surgery in patients with non-dysplastic Barrett's esophagus for the prevention of progression to dysplasia/adenocarcinoma. [ABSTRACT FROM AUTHOR]

Background & Aims: Non-alcoholic steatohepatitis (NASH) is an independent risk factor for cardiovascular disease (CVD) morbidity after liver transplantation, but its impact on CVD mortality is unknown. We sought to assess the impact of NASH on CVD mortality after liver transplantation and to predict which NASH recipients are at highest risk of a CVD-related death following a liver transplant. Methods: Using the Organ Procurement and Transplantation Network database, we examined associations between NASH and post-liver transplant CVD mortality, defined as primary cause of death from thromboembolism, arrhythmia, heart failure, myocardial infarction or stroke. A physician panel reviewed cause of death. Results: Of 48 360 liver transplants (2/2002-12/2011), 5057 (10.5%) were performed for NASH cirrhosis. NASH recipients were more likely to be older, female, obese, diabetic and have history of renal failure or prior CVD vs. non-NASH (P < 0.001 for all). Although there was no difference in overall all-cause mortality (log-rank P = 0.96), both early (30-day) and long-term CVD-specific mortality was increased among NASH recipients (Odds ratio = 1.30, 95% Confidence interval (CI): 1.02-1.66; Hazard ratio = 1.42, 95% CI: 1.07-1.41 respectively). These associations were no longer significant after adjustment for pretransplant diabetes, renal impairment or CVD. A risk score comprising age ≥55, male sex, diabetes and renal impairment was developed for prediction of post-liver transplant CVD mortality (c-statistic 0.60). Conclusion: NASH recipients have an increased risk of CVD mortality after liver transplantation explained by a high prevalence of comorbid cardiometabolic risk factors that in aggregate identify those at highest risk of post-transplant CVD mortality. [ABSTRACT FROM AUTHOR]

Introduction Direct-to-consumer ads for testosterone replacement therapies have significantly increased over the past several years. Subsequently, testing for low serum testosterone has correspondingly increased. Aims We sought to determine the testing behaviors of practitioners as well as the characteristics of men who are undergoing testing for low testosterone. Methods Men aged 18-85 years were queried from the institutional electronic data warehouse from 2009 to 2012. Men were considered 'tested' if their serum total testosterone level had been measured for any purpose. Tested men ( TM) were compared with those not tested ( NT). Main Outcome Measures The frequency and timing of testing for low testosterone as well as patient demographics and clinical characteristics were compared between TM and NT using multivariable logistic regression models. Results Of the 321,674 total men, 10,133 (3.2%) underwent testing with a serum total testosterone (mean age of 55.2 ± 14.1 years). The frequency of testing increased from 2.5% to 3.6% during the study period ( P < 0.001). Multivariable analysis demonstrated that TM were significantly ( P < 0.001) more likely to be Caucasian and have increased body mass index. In addition, TM were significantly more likely to have comorbid conditions including decreased libido (adjusted odds ratio [ aOR] 10.0, 95% confidence interval [ CI] 8.5, 11.7), infertility ( aOR 4.8, 95% CI 3.6, 6.6), erectile dysfunction (a OR 3.6, 95% CI 3.4, 3.8), osteoporosis ( aOR 3.3, 95% CI 2.8, 3.8), depression ( aOR 1.7, 95% CI 1.6, 1.8), prostate cancer ( aOR 1.7, 95% CI 1.5, 1.8), hypertension ( aOR 1.3. 95% CI 1.2, 1.4), chronic obstructive pulmonary disease ( aOR 1.2, 95% CI 1.0, 1.4), and benign prostatic hyperplasia ( aOR 1.2, 95% CI 1.1, 1.2). Among TM, only 889 (9%) men underwent testing between 7 am and 12 pm. Conclusions The rate of testosterone testing is increasing with most testing practices directed toward a subset of men with comorbidities that are associated with hypogonadism. Compliance of physicians obtaining early morning serum testosterone levels is low. Further education of practitioners is required to appropriately test patients for hypogonadism. Malik RD, Lapin B, Wang CE, Lakeman JC, and Helfand BT. Are we testing appropriately for low testosterone?: Characterization of tested men and compliance with current guidelines. J Sex Med 2015;12:66-75. [ABSTRACT FROM AUTHOR]

Introduction: Barrett's esophagus (BE) is the most predictive risk factor for development of esophageal adenocarcinoma (EAC), a malignancy with the fastest increasing incidence in the US. The aim of this study was to investigate differences in exposures, demographics, and comorbidities between regressing and non-regressing patients. Methods and procedures: We retrospectively collected and analyzed data from a cohort of BE patients participating in a single-center study comprised of all patients diagnosed with BE over a 10-year period. We collected information from the patient's electronic medical records regarding demographic data, endoscopic findings, histological findings, exposures, and history of antireflux surgery. Results: This study included 1,342 BE patients, 505 (37.6 %) of which experienced regression. The regressed group was 52.3 % male, while the non-regressing group was 68.3 % male ( p < 0.001). Mean age was 65.2 ± 12.8 and 62.0 ± 13.1 years for non-regressing and regressing patients, respectively ( p < 0.001). No difference was seen in BMI between regressing and non-regressing groups (27.5 ± 5.7 vs. 27.7 ± 5.4, p = 0.52). No difference was seen between groups with respect to PPI use (93.5 % non-regressing vs. 94.1 % regressed patients, p = 0.70), but regressed patients were more likely to take vitamin D than non-regressing patients (34.1 vs. 42.1 %, p = 0.003). Regressed patients had an average segment length of 1.48 cm (±1.58 cm), in contrast to those not regressing (3.58 ± 3.09 cm ( p < 0.001)). Interestingly, one patient in the regression group progressed to dysplasia, while 101 of the non-regressing patients progressed to dysplasia/EAC, a result found to be independent of segment length on multivariate analysis ( p < 0.001). Conclusions: Currently, several studies have shown risk factors that can predict progression of non-dysplastic BE, but few investigate predictors for regression. Our study reports several factors that can be used to predict patients who will regress from BE and those who likely will not, tools that will be useful in tailoring therapeutic and surveillance strategies. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to conduct item reduction of the Memory Assessment Clinics Self-Rating Scale (MAC-S) to create a briefer measure that can be used to quickly evaluate subjective memory complaints in patients with epilepsy. Method: A total of 1333 adults with focal epilepsy completed the original 49-item MAC-S. The sample was randomly split into three subsamples, and a series of analyses (i.e. exploratory factor analysis, confirmatory factor analysis, and item response theory analyses) was conducted to identify an alternative factor structure, with a reduced number of items. A panel of 5 neuropsychologists independently reviewed the final model to assess appropriateness of each individual item as well as the factor loadings and overall factor structure. Final factor titles were subsequently decided as a group. Results: Five factors were identified: Attention, Working Memory, Retrieval, Semantic Memory, and Episodic Memory. The length of the MAC-S was reduced from 49 to 30 items, with items being removed because they failed to load onto any of the factors substantially, or because of poor item discrimination or threshold levels. Conclusions: The Memory Assessment Clinics Scale for Epilepsy (MAC-E), is an updated, brief measure of subjective memory functioning that can be used to efficiently assess relevant, every-day memory abilities in patients with epilepsy within both clinical and research settings. [ABSTRACT FROM AUTHOR]

Objective: Examine sequence of weakness in arm muscles from longitudinal hand-held dynamometry (HHD) data in ALS for congruence with contiguous spread of neurodegeneration along spinal cord segments. Methods: Longitudinal HHD data from the Ceftriaxone clinical trial were examined using nonlinear mixed models, assuming a logistic trajectory from normal to zero strength. Unobserved baseline normal strength of weak muscles was assumed using strength of the best-preserved muscle. A novel metric called "time from onset to midway strength" (TOMS) was estimated for each muscle group, and TOMS ratios were examined to identify sequence of weakness, overall and by onset site. Results: Shoulder flexion (SF), elbow flexion (EF), elbow extension (EE), wrist extension (WE), and first dorsal interosseous (FDI) were measured on each side. Over a median of 36 weeks, 513 subjects provided 2589 sets of HHD measures. TOMS increased sequentially in the following order: FDI, WE, SF, EF, and EE. TOMS ratios estimates with 95% CIs (adjusted for multiple comparisons) were: WE/FDI 1.32 (1.24–1.41), SF/WE 1.06 (1.01–1.10), EF/SF 1.06 (1.02–1.10), and EE/EF 1.18 (1.12–1.23). Elbow and shoulder flexors weakened sooner than did elbow extensors. The sequence of arm muscle weakness progression was similar regardless of onset site. Conclusion: Nonsegmental progression of arm muscle weakness that is similar for different onset sites favors cortical influence/network spread over contiguous spread of neurodegeneration in the spinal cord. Furthermore, this study confirms the "split elbow" pattern. TOMS and other proposed methods may have value as outcome measures in clinical research. [ABSTRACT FROM AUTHOR]

As the implementation of Patient-Reported Outcomes Measurement Information System (PROMIS) scales has increased, so has the number of studies linking legacy scale scores to PROMIS scale scores. Variability in linked scores for a given PROMIS score can be considerable, leading to potential bias. An alternative method is imputation using a bridge study. We sought to compare linking to this alternative novel method in group-level analyses using linked legacy scores. Adult patients who completed PROMIS Depression and Patient Health Questionnaire (PHQ-9) were included. We randomly allocated data samples to be missing either PROMIS Depression or PHQ-9. We estimated PROMIS T scores using six methods: Linking methods by Choi et al. (2014), linking in our internal data, imputation using bridge study data from external data and from our internal data, each with and without patient demographics. Estimated mean PROMIS T scores using the linking and imputation methods were compared to actual PROMIS T scores across varying proportions of missingness and sample size. We also compared regression coefficients for the six estimation methods to a model using actual PROMIS T scores. Mean estimated versus actual PROMIS T scores varied between 1 and 4 points for the linking methods and within 0.4 points for the imputation method using internal data with patient demographics. The imputation methods had estimated regression coefficients closer to that of the model using actual scores as compared to the linking methods. For group-level analyses, imputation using a bridge study may be a feasible alternative to using linked scores or can be used as a sensitivity analysis. Public Significance Statement: Many legacy scales have been linked to associated PROMIS scales using item response theory and other linking strategies. Group-level analyses involving such linked scores sometimes result in biased parameter estimates. We propose an alternative analysis approach: Imputation using a bridge study. The study findings indicate that imputation using a bridge study may be a feasible alternative to analyzing legacy scale data scored on a PROMIS metric. [ABSTRACT FROM AUTHOR]

A subset of patients with diabetic polyneuropathy (DPN) have significant pain. There is little information on how patients with painful diabetic polyneuropathy (DPN+P) differ from those with DPN without pain (DPN-P). The objective was to determine differences in demographics, socioeconomic characteristics, and patient-reported quality-of-life (QoL) between DPN+P and DPN-P patients. We used an algorithm of high sensitivity (90%) and moderate specificity (60%) to electronically classify patients within our institution between 2009 and 2016 as no DPN, DPN+P, or DPN-P. QoL was assessed as part of standard of care using PROMIS Global Health mental and physical summary scores, and PHQ-9 depression screen. We report clinically and statistically significant (p<0.05) differences between DPN+P and DPN-P. Independent associations with DPN+P were evaluated using multivariable logistic regression models.Of 43,945 patients with type 2 diabetes, 13,910 (32%) had DPN, of whom 9,104 patients had DPN+P (65%) and 4,806 had DPN-P (35%). Patients with DPN+P were significantly younger than DPN-P (68±13 vs. 66±13), and more likely to be female (55% vs. 44%). Compared to DPN-P, DPN+P patients were less frequently white (67% vs. 72%), less frequently married (47% vs. 54%), had lower median household income ($50.6k vs. $55.5k), and were more likely to be covered by Medicaid (14% vs. 7%) and less likely to have private health insurance (21% vs. 29%). QoL measures, PROMIS and PHQ-9 scores, were significantly worse for patients with DPN+P vs. DPN-P. Younger age, female sex, and worse QoL remained independently associated with DPN+P after adjustment. Demographic, socioeconomic, and QoL associations could be causative of pain, perhaps mediated through poorer diabetes care, and could be consequences of pain, mediated through loss of productivity. This reciprocal effect and the economic magnitude of the problem warrant longitudinal study of the risk factors and natural history of pain in DPN. Disclosure: B. Lapin: None. S. Morrison: None. A. Schuster: None. K. Johnson: Employee; Self; Novartis Pharmaceuticals Corporation. F. Boulos: Employee; Self; Novartis Pharmaceuticals Corporation. N.J. Thakore: Research Support; Self; Novartis Pharmaceuticals Corporation. A. Milinovich: Research Support; Self; Amgen Inc., Celgene Corporation, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Otsuka Pharmaceutical Co., Ltd. [ABSTRACT FROM AUTHOR]

• Fatigue is a common reported complaint in patients with mitochondrial disease. • Rates of fatigue were assessed in adult patients with genetic mitochondrial disease. • Rates of depression, anxiety and sleep disorders were also assessed. • Fatigue was found to be very common with 71–100% of patients reporting fatigue. • Depression, anxiety & sleep problems were present in rates seen in multiple sclerosis. Rates of perceived fatigue, anxiety, depression, sleepiness and mitochondrial disease severity were assessed prospectively in 2017–2018 using established validated questionnaires in 48 adult patients with genetically confirmed primary mitochondrial disease. Fatigue was found to be very common among patients with primary mitochondrial disease, with 34 to 48 (71–100%) patients reporting fatigue depending on the measure used, and the severity of fatigue correlating with the severity of disease. Moderate-to-severe depression (10/48; 20.8%) anxiety (28/48; 58.3%) and sleep problems (16/48; 33.3%) were frequent in our patients with fatigue and these conditions were even more prevalent in those with severe fatigue. In conclusion, perceived fatigue was common in patients with primary mitochondrial disease and appeared to correlate with disease severity. Depression, anxiety and sleep disorders were more common in the cohort than those with other chronic diseases but with rates similar to that seen in multiple sclerosis. The severity of perceived fatigue correlated with an increased risk of these comorbid conditions. The Fatigue Severity Scale may more selectively measure non-anxiety/sleep-related fatigue in primary mitochondrial disease and additional testing is planned. [ABSTRACT FROM AUTHOR]

Introduction: For adequate adenoma detection rate (ADR), guidelines recommend a mean withdrawal time (MWT) of ≥ 6 min. ADR has been shown to correlate strongly with proximal serrated polyp detection rate (PSP-DR), which is another suggested quality measure for screening colonoscopy. However, the impact of directly measured withdrawal time on PSP-DR has not been rigorously studied. We examined the relationship between MWT to ADR and PSP-DR, with the aim of identifying a functional threshold withdrawal time associated with both increased ADR and PSP-DR.Methods: This was a retrospective study of endoscopy and pathology data from average-risk screening colonoscopy examinations performed at a large system with six endoscopy laboratories. A natural language processing tool was used to determine polyp location and histology. ADR and PSP-DR were calculated for each endoscopist. MWT was calculated from colonoscopy examinations in which no polyps were resected.Results: In total, 31,558 colonoscopy examinations were performed, of which 10,196 were average-risk screening colonoscopy examinations with cecal intubation and adequate prep by 24 gastroenterologists. When assessing the statistical significance of increasing MWT by minute, the first significant time mark for PSP-DR was at 11 min at a rate of 14.2% (p = 0.01). There was a significant difference comparing aggregated MWT < 11 min compared to ≥ 11 min looking at the rates of adenomas [OR 1.65 (1.09-2.51)] and proximal serrated polyps [OR 1.81 (1.06-3.08)]. While ADR linearly correlated well with MWT (R = 0.76, p < 0.001), the linear relationship with PSP-DR was less robust (R = 0.42, p = 0.043).Conclusion: In this large cohort of average-risk screening colonoscopy, a MWT of 11 min resulted in a statistically significant increase in both ADR and PSP-DR. Our data suggest that a longer withdrawal time may be required to meet both quality metrics. [ABSTRACT FROM AUTHOR]

Objective: To describe differences in clinical and demographic characteristics between patients with episodic migraine (EM) or chronic migraine (CM) and determine the effect of migraine subtype on patient‐reported outcome measures (PROM). Background: Prior studies have characterized migraine in the general population. While this provides a basis for our understanding of migraine, we have less insight into the characteristics, comorbidities, and outcomes of migraine patients who present to subspecialty headache clinics. These patients represent a subset of the population that bears the greatest burden of migraine disability and are more representative of migraine patients who seek medical care. Valuable insights can be gained from a better understanding of CM and EM in this population. Methods: We conducted a retrospective observational cohort study of patients with CM or EM seen in the Cleveland Clinic Headache Center between January 2012 and June 2017. Demographics, clinical characteristics, and patient‐reported outcome measures (3‐Level European Quality of Life 5‐Dimension [EQ‐5D‐3L], Headache Impact Test‐6 [HIT‐6], Patient Health Questionnaire‐9 [PHQ‐9]) were compared between groups. Results: Eleven thousand thirty‐seven patients who had 29,032 visits were included. More CM patients reported being on disability 517/3652 (14.2%) than EM patients 249/4881 (5.1%) and had significantly worse mean HIT‐6 (67.3 ± 7.4 vs. 63.1 ± 7.4, p < 0.001) and median [interquartile range] EQ‐5D‐3L (0.77 [0.44–0.82] vs. 0.83 [0.77–1.00], p < 0.001), and PHQ‐9 (10 [6–16] vs. 5 [2–10], p < 0.001). Conclusions: There are multiple differences in demographic characteristics and comorbid conditions between patients with CM and EM. After adjustment for these factors, CM patients had higher PHQ‐9 scores, lower quality of life scores, greater disability, and greater work restrictions/unemployment. [ABSTRACT FROM AUTHOR]

• Patient-reported outcome measures (PROMs) of >500 stroke survivors with suspected acute symptomatic seizure (ASyS) evaluated. • One in 5 patients had convulsive or electrographic ASyS; 37.4% were discharged on antiseizure medications (ASMs). • Physical Function and Satisfaction with Social Roles and Activities were the most affected health domains. • PROMs comparable between groups: ASyS (electrographic and/or convulsive), ASM use (hospital discharge/day of PROM). • Lack of impact of ASyS and associated ASM use on PROMs suggests need to create ASyS-specific PROMs. Acute symptomatic seizures (ASyS) after stroke are not uncommon. However, the impact of ASyS and its management with anti-seizure medications (ASMs) on patient-reported outcome measures (PROMs) remains poorly investigated. The objective of our study is to evaluate the association between PROMs and ASyS and ASMs following stroke. We performed a retrospective cohort study of all stroke patients who underwent inpatient continuous EEG (cEEG) monitoring performed due to suspected ASyS, including the ones with observed convulsive ASyS, from 04/01/2012 to 03/31/2018, who completed PROMs within 6 months of hospital discharge. Patient-reported outcome measures, including one Neuro-QoL and six PROMIS v1.0 domain scales, were completed by patients as the standard of care in ambulatory stroke clinics. Since ASMs are sometimes used without clearly diagnosed ASyS, we performed group comparisons based on ASM status at discharge, irrespective of their ASyS status. T-tests or Wilcoxon rank sum tests compared continuous variables across groups and chi-square tests or Fisher's exact tests were used for categorical variables. A total of 508 patients were included in the study [mean age 62.0 ± 14.1 years, 51.6% female; 244 (48.0%) ischemic stroke, 165 (32.5%) intracerebral hemorrhage, and 99 (19.5%) subarachnoid hemorrhage]. A total of 190 (37.4%) patients were discharged on ASMs. At the time of the first PROM, conducted a median of 47 (IQR = 33–78) days after the suspected ASyS, and 162 (31.9%) were on ASMs. ASM use was significantly higher in patients diagnosed with ASyS. Physical Function and Satisfaction with Social Roles and Activities were the most affected health domains. Patient-reported outcome measures were not significantly different between groups based on ASyS (electrographic and/or convulsive), ASM use at hospital discharge, or ASM status on the day of PROM completion. There were no differences in multiple domain-specific PROMs in patients with recent stroke according to ASyS status or ASM use suggesting the possible lack of the former's sensitivity to detect their impact. Additional research is necessary to determine if there is a need for developing ASyS-specific PROMs. [ABSTRACT FROM AUTHOR]

Objectives: To compare clinical characteristics among outpatient headache clinic patients who do and do not self‐report visiting the emergency department for headache. Background: Headache is the fourth most common reason for emergency department visits, compromising 1%–3% of visits. Limited data exist about patients who are seen in an outpatient headache clinic but still opt to frequent the emergency department. Clinical characteristics may differ between patients who self‐report emergency department use and those who do not. Understanding these differences may help identify which patients are at greatest risk for emergency department overutilization. Methods: This observational cohort study included adults treated at the Cleveland Clinic Headache Center between October 12, 2015 and September 11, 2019, who completed self‐reported questionnaires. Associations between self‐reported emergency department utilization and demographics, clinical characteristics, and patient‐reported outcome measures (PROMs: Headache Impact Test [HIT‐6], headache days per month, current headache/face pain, Patient Health Questionnaire‐9 [PHQ‐9], Patient‐Reported Outcomes Measurement Information System [PROMIS] Global Health [GH]) were evaluated. Results: Of the 10,073 patients (mean age 44.7 ± 14.9, 78.1% [7872/10,073] female, 80.3% [8087/10,073] White patients) included in the study, 34.5% (3478/10,073) reported visiting the emergency department at least once during the study period. Characteristics significantly associated with self‐reported emergency department utilization included younger age (odds ratio = 0.81 [95% CI = 0.78–0.85] per decade), Black patients (vs. White patients) (1.47 [1.26–1.71]), Medicaid (vs. private insurance) (1.50 [1.29–1.74]), and worse area deprivation index (1.04 [1.02–1.07]). Additionally, worse PROMs were associated with greater odds of emergency department utilization: higher (worse) HIT‐6 (1.35 [1.30–1.41] per 5‐point increase), higher (worse) PHQ‐9 (1.14 [1.09–1.20] per 5‐point increase), and lower (worse) PROMIS‐GH Physical Health T‐scores (0.93 [0.88–0.97]) per 5‐point increase. Conclusion: Our study identified several characteristics associated with self‐reported emergency department utilization for headache. Worse PROM scores may be helpful in identifying which patients are at greater risk for utilizing the emergency department. [ABSTRACT FROM AUTHOR]