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PURPOSE: Untreated obstructive sleep apnea (OSA) in patients with acute ischemic stroke (AIS) is associated with increased morbidity and mortality. However, diagnosing and treating OSA in AIS is challenging. We aimed to determine the feasibility of portable monitoring (PM) for diagnosis and positive airway pressure therapy for treatment of OSA in an inpatient stroke population. METHODS: We recruited inpatients with AIS from Cleveland Clinic. Those who consented underwent PM; participants with a respiratory event index (REI) ≥ 10 were offered auto-titrating positive airway pressure therapy (APAP). Ease-of-use questionnaires were completed. We summarized categorical variables using n(%) and continuous variables using mean ± SD or median [IQR]. RESULTS: 27 participants (age 59.8 ± 11.8, 51.9% female, 51.9% Black, BMI 33.4 ± 8.5) enrolled. The study ended early due to Medicare contracting that forced most patients to complete stroke rehabilitation outside the Cleveland Clinic health system. 59.3% had large vessel occlusions and 53.8% had moderate/severe disability (Modified Rankin score ≥ 2). PM was attempted in 21 participants, successful in 18. Nurses and patients rated the PM device as highly easy to use. 13 of 18 (72%) patients who had an REI ≥ 10 consented to APAP titration, but only eight (61.5%) of those 13 used APAP for more than one night, and only five (27.8%) used APAP up to 90 days with data captured for only one participant. Five required troubleshooting at titration, and only one had adherent APAP usage by objective assessment after discharge. CONCLUSIONS: This study demonstrates the real-world challenges of assessing and treating OSA in an AIS population, highlighting the necessity for further research into timely and feasible screening and treatment.

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INTRODUCTION: Given the prevalence and staggering cost of neurological disorders, there is dire need for effective early detection and intervention tools. Emerging evidence suggests that multidisciplinary lifestyle interventions (MLI) may mitigate the risk and progression of neurological disorders. The objectives of this protocol are (1) to test the impact of MLI on the progression of neurological disorders and (2) to identify multi-omic biomarkers for early stages of neurological disease and the impact of MLIs on these biomarkers. METHODS AND ANALYSIS: We present the Multidisciplinary lifestyle Interventions for Neurological Disorders during the Silent phase (MINDS) protocol, a randomized controlled trial of MLI in neurologically healthy older adults (≥ 50 years old) exhibiting elevated risk for common neurological disorders: stroke, epilepsy, Parkinson's Disease, or Alzheimer's disease and related dementias. Participants will be randomly assigned to intervention (n = 100) or control (n = 100) groups. The intervention group will receive 3 months of weekly 2-hour sessions on diet education, yoga, music therapy, and cognitive skills training. The participants' neurological health and engagement in relevant lifestyle practices will be assessed at regular intervals for 12 months. Neuroimaging and samples for multi-omic analyses will be collected at baseline, and at 3 months and 12 months after enrollment. Primary outcomes will be signs of progression of the neurological disorder risk that qualified them for study enrollment or a clinical diagnosis of the disorder. Secondary and exploratory outcomes will be based on self-reported health and multi-omic data. Data analysis will include between-group and longitudinal within-group analyses. PERSPECTIVES: The MINDS protocol and trial aims to clarify the impact of MLI on the progression of neurological disorder risk or diagnosis in older adults and to identify biomarkers that can be used to confirm MLI efficacy. The ability to validate the impact of MLI on neurological disorder progression based on biomarker data allows the identification of individuals most likely to benefit from such therapies in the early stages of neurological disease. TRIAL REGISTRATION: The trial is registered on the National Institutes of Health (NIH) ClinicalTrials.gov (NCT05984056) site. It was registered on August 2nd, 2023. The trial has full approval of the Cleveland Clinic Internal Review Board.

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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.

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BACKGROUND: The EQ-5D and Health Utilities Index Mark 3 (HUI-3) are preference-based measures used in cost-effectiveness studies. The Patient Reported Outcomes Measurement Information System (PROMIS) Preference scoring system (PROPr) is a new preference-based measure. In addition, algorithms were previously developed to map PROMIS Global Health (PROMIS-GH) items to HUI-3 using linear equating (HUILE) and 3-level EQ-5D using linear (EQ5DLE). We sought to evaluate and compare estimated utilities based on PROPr and PROMIS-GH in adult stroke survivors. METHODS: We performed a retrospective cohort study of adults diagnosed with 1 of ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage seen in an outpatient clinic between 2015 and 2019. Patients completed PROMIS scales and other measures. We computed a modified version of PROPr (mPROPr) and compared the distributional characteristics and correlations with stroke outcomes for mPROPr, HUILE, and EQ5DLE. RESULTS: T toal of 4,159 stroke survivors (average age 62.7 ± 14.7 y, 48.4% female, 77.6% ischemic stroke) were included. Mean utility estimates for mPROPr, EQ5DLE, and HUILE were 0.333 ± 0.244, 0.739 ± 0.201, and 0.544 ± 0.301, respectively. Correlations between the modified Rankin Scale and each of mPROPr and HUILE were both -0.48 and -0.43 for EQ5DLE. Regression analyses indicated that mPROPr scores may be too low for stroke patients in good health and that EQ5DLE scores may be too high for stroke patients in poor health. CONCLUSIONS: All 3 PROMIS-based utilities were associated with measures of stroke disability and severity, but the distributions of utilities were very different. Our study highlights the problem cost-effectiveness researchers face of valuing health states with certainty. For researchers using utilities estimated from PROMIS scales, our study indicates that mapping PROMIS-GH item scores to HUI-3 via linear equating may be most appropriate in stroke patients. HIGHLIGHTS: A new preference-based measure has been developed from the Patient Reported Outcomes Measurement Information System (PROMIS), known as the PROMIS-Preference (PROPr) scoring system, and published equations mapping PROMIS Global Health (PROMIS-GH) items to the Health Utilities Index Mark 3 (HUI-3) and EQ-5D-3L are available for use in cost-effectiveness studies.Our study provides distributional characteristics and comparisons of utilities estimated using a modified version of PROPr and equations mapping PROMIS-GH items to EQ-5D-3L and HUI-3 in a sample of stroke survivors.The results of our study show large differences in the distributions of utilities estimated using the different health state measures, and these differences highlight the ongoing difficulty researchers face in valuing health states with certainty.

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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.

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PURPOSE: Cognitive impairment is a common consequence of stroke and has direct implications for poststroke functioning and quality of life, including the ability to maintain a job, live independently, sustain interpersonal relationships, and drive a vehicle. In this scientific statement, we critically appraise the literature on the prevalence, diagnosis, and management of poststroke cognitive impairment (PSCI) and provide a framework for clinical care while highlighting gaps that merit further study. METHODS: We performed a scoping literature review of randomized controlled clinical trials, prospective and retrospective cohort studies, case-control studies, clinical guidelines, review articles, and editorials on the incidence and prevalence, natural history, diagnosis, and management of PSCI. Scoping reviews determine the scope of a body of literature on a given topic to indicate the volume of literature and the studies currently available and provide an overview of its focus. RESULTS: PSCI is common after stroke, especially in the first year, and ranges from mild to severe. Although cognitive impairment is reversible in some cases early after stroke, up to one-third of individuals with stroke develop dementia within 5 years. The pathophysiology is not yet fully elucidated but is likely attributable to an acute stroke precipitating a series of pathological events, often in the setting of preexisting microvascular and neurodegenerative changes. Screening for associated comorbidities and interdisciplinary management are integral components of the care of individuals with PSCI. There is a need for prospective studies evaluating the individual trajectory of PSCI and the role of the acute vascular event in the predisposition for Alzheimer disease and related dementias, as well as high-quality, randomized clinical trials focused on PSCI management.

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BACKGROUND CONTEXT: 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. PURPOSE: 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. STUDY DESIGN: Retrospective cohort study. PATIENT SAMPLE: 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. OUTCOME MEASURES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

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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.

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Background: Prior work by our group developed a stratification tool based on four PROMIS domains for patients with low back pain (LBP). Our study aimed to evaluate the ability of our previously developed symptom classes to predict long-term outcomes, and determine whether there were differential treatment effects by intervention. Methods: This was a retrospective cohort study of adult patients with LBP seen in spine clinics in a large health system between November 14, 2018 and May 14, 2019 who completed patient-reported outcomes as part of routine care at baseline and again at 12-months follow-up. Latent class analysis identified symptom classes based on PROMIS domain scores (physical function, pain interference, social role satisfaction, and fatigue) that were ≥1 standard deviation worse (meaningfully worse) than the general population. The ability of the profiles to predict long-term outcomes at 12-months was evaluated through multivariable models. Differences in outcomes by subsequent treatments (physical therapy, specialist visits, injections, and surgery) were investigated. Results: There were 3,236 adult patients (average age 61.1 ± 14.2, 55.4% female) included in the study with three distinct classes identified: mild symptoms (n = 986, 30.5%), mixed (n = 798, 24.7%) with poor scores on physical function and pain interference but better scores on other domains, and significant symptoms (n = 1,452, 44.9%). The classes were significantly associated with long-term outcomes, with patients with significant symptoms improving the most across all domains. Utilization differed across classes, with the mixed symptom class receiving more PT and injections and significant symptom class receiving more surgeries and specialist visits. Conclusions: Patients with LBP have distinct clinical symptom classes which could be utilized to stratify patients into groups based on risk of future disability. These symptom classes can also be used to provide estimates of the effectiveness of different interventions, further increasing the clinical utility of these classes in standard care.

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OBJECTIVE: 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. METHODS: 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. RESULTS: 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. SIGNIFICANCE: 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.

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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.

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The functional medicine model of care is focused on patient-centered rather than disease-centered care. Patient-centered care incorporates the patient's voice or experience of their condition alongside conventional biological factors to provide a "more complete" account of health. PROMIS Global, an NIH-validated patient-reported outcome (PRO) measure that evaluates the health-related quality of life, can be incorporated within the functional medicine model of care to evaluate self-reported physical, mental and social well-being across various conditions and guide personalized management strategies. Proper incorporation of PROMIS Global into clinical care and research is warranted to expand the available evidence base.

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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.

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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.

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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.

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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.

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BACKGROUND: Caregivers, or proxies, often complete patient-reported outcomes (PROs) on behalf of patients; yet, research has demonstrated proxies rate patient outcomes worse than patients rate their own outcomes. To improve interpretability of PROs in group-level analyses, our study aimed to identify optimal approaches for reducing proxy-introduced bias in the analysis of PROs. METHODS: Data were simulated based on 200 patients with stroke and their proxies who both completed 9 PROMIS domains as part of a cross-sectional study. The sample size was varied as 50, 100, 200, and 500, and the proportion of patients with proxy-respondents was varied as 10%, 20%, and 50%. Six methods for handling proxy-completions were investigated: (1) complete case analysis; (2) proxy substitution; (3) Method 2 plus proxy adjustment; (4) Method 3 including inverse-probability of treatment weighting; (5) multiple imputation; (6) linear equating. These methods were evaluated by comparing average bias in PROMIS T-scores (estimated versus observed patient-only responses), as well as by comparing estimated regression coefficients to models using patient-only responses. RESULTS: Overall mean T-score differences ranged from 0 to 1.75. The range of mean differences varied by the 6 methods with methods 1 and 5 providing estimates closest to the observed mean. In regression models, all but inverse-probability of treatment weighting resulted in low bias when proxy-completions were 10% to 20%. With 50% proxy-completions, method 5 resulted in less accurate estimations while methods 1 to 3 provided less proxy-introduced bias. Bias remained low across domain and varying sample sizes but increased with larger percentages of proxy-respondents. CONCLUSIONS: Our study found modest proxy-introduced bias when estimating PRO scores or regression estimates across multiple domains of health. This bias remained low, even when sample size was 50 and there were large proportions of proxy-completions. While many of these methods can be chosen for including proxies in stroke PRO research with <20% proxy-respondents, proxy substitution with adjustment resulted in low bias with 50% proxy-respondents.

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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.

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OBJECTIVE: To investigate the factors associated with the long-term continuation of anti-seizure medications (ASMs) in acute stroke patients. METHODS: We performed a retrospective cohort study of stroke patients with concern for acute symptomatic seizures (ASySs) during hospitalization who subsequently visited the poststroke clinic. All patients had continuous EEG (cEEG) monitoring. We generated a multivariable logistic regression model to analyze the factors associated with the primary outcome of continued ASM use after the first poststroke clinic visit. RESULTS: A total of 507 patients (43.4% ischemic stroke, 35.7% intracerebral hemorrhage, and 20.9% aneurysmal subarachnoid hemorrhage) were included. Among them, 99 (19.5%) suffered from ASySs, 110 (21.7%) had epileptiform abnormalities (EAs) on cEEG, and 339 (66.9%) had neither. Of the 294 (58%) patients started on ASMs, 171 (33.7%) were discharged on them, and 156 (30.3% of the study population; 53.1% of patients started on ASMs) continued ASMs beyond the first poststroke clinic visit [49.7 (±31.7) days after cEEG]. After adjusting for demographical, stroke- and hospitalization-related variables, the only independent factors associated with the primary outcome were admission to the NICU [Odds ratio (OR) 0.37 (95% CI 0.15-0.9)], the presence of ASySs [OR 20.31(95% CI 9.45-48.43)], and EAs on cEEG [OR 2.26 (95% CI 1.14-4.58)]. INTERPRETATION: Almost a third of patients with poststroke ASySs concerns may continue ASMs for the long term, including more than half started on them acutely. Admission to the NICU may lower the odds, and ASySs (convulsive or electrographic) and EAs on cEEG significantly increase the odds of long-term ASM use.

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