Health-Related Quality of Life for Patients with Post-Acute COVID-19 Syndrome: Identification of Symptom Clusters and Predictors of Long-Term Outcomes.

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.

Utilities Estimated from PROMIS Scales for Cost-Effectiveness Analyses in Stroke.

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.

Clinical characteristics and patient-reported outcomes of chronic and episodic migraine patients at a US tertiary headache center: A retrospective observational study.

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.

Comparison of stratification techniques for optimal management of patients with chronic low back pain in spine clinics.

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.

Cognitive Impairment After Ischemic and Hemorrhagic Stroke: A Scientific Statement From the American Heart Association/American Stroke Association.

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.

Stratification of spine patients based on self-reported clinical symptom classes: Evaluation of long-term outcomes and subsequent interventions.

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.

Impact of acute symptomatic seizures and their management on patient-reported outcomes after stroke.

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.

PROMIS global health: potential utility as a screener to trigger construct-specific patient-reported outcome measures in clinical care.

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.

Mapping PROMIS physical function and pain interference to the modified low back pain disability questionnaire.

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.

Stratification of spine patients based on self-reported clinical symptom classes.

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.

Health-Related Quality of Life Mildly Affected Following COVID-19: a Retrospective Pre-post Cohort Study with a Propensity Score-Matched Control Group.

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.

Optimal Methods for Reducing Proxy-Introduced Bias on Patient-Reported Outcome Measurements for Group-Level Analyses.

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.

Evidence of Stability in Patient-Reported Global Health During the COVID-19 Pandemic.

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.

Patient-proxy agreement on change in acute stroke patient-reported outcome measures: a prospective study.

OBJECTIVES: Research has indicated proxies overestimate symptoms on patients' behalves, however it is unclear whether patients and proxies agree on meaningful change across domains over time. The objective of this study is to assess patient-proxy agreement over time, as well as agreement on identification of meaningful change, across 10 health domains in patients who underwent acute rehabilitation following stroke. METHODS: Stroke patients were recruited from an ambulatory clinic or inpatient rehabilitation unit, and were included in the study if they were undergoing rehabilitation. At baseline and again after 30 days, patients and their proxies completed PROMIS Global Health and eight domain-specific PROMIS short forms. Reliability of patient-proxy assessments at baseline, follow-up, and the change in T-score was evaluated for each domain using intra-class correlation coefficients (ICC(2,1)). Agreement on meaningful improvement or worsening, defined as 5+ T-score points, was compared using percent exact agreement. RESULTS: Forty-one patient-proxy dyads were included in the study. Proxies generally reported worse symptoms and functioning compared to patients at both baseline and follow-up, and reported less change than patients. ICCs for baseline and change were primarily poor to moderate (range: 0.06 (for depression change) to 0.67 (for physical function baseline)), and were better at follow-up (range: 0.42 (for anxiety) to 0.84 (for physical function)). Percent exact agreement between indicating meaningful improvement versus no improvement ranged from 58.5-75.6%. Only a small proportion indicated meaningful worsening. CONCLUSIONS: Patient-proxy agreement across 10 domains of health was better following completion of rehabilitation compared to baseline or change. Overall change was minimal but the majority of patient-proxy dyads agreed on meaningful change. Our study provides important insight for clinicians and researchers when interpreting change scores over time for questionnaires completed by both patients and proxies.

Changes in Health-Related Quality of Life After Transient Ischemic Attack.

Importance: Numerous studies have found that patients diagnosed with TIA have decreased health-related quality of life, which has been interpreted as suggesting that patients with TIA have residual symptoms after the event. Studies assessing health status in the same patients before and after an event are lacking but may allow a direct determination of the association of TIA with postevent health status. Objective: To examine patient-reported health before transient ischemic attack (TIA) among individuals diagnosed with this event and evaluate change in patient-reported health after the event overall and by TIA characterization subgroups. Design, Setting, and Participants: This cohort study was conducted among 236 patients with a clinical diagnosis of TIA from October 2015 to December 2017 in a large US health system that collects a patient-reported outcome measure in ambulatory setting as part of routine care. Included patients had patient-reported global health scale assessments completed as part of routine care before and after a TIA event. Data were analyzed from March through July 2020. Main Outcomes and Measures: The main outcome was Patient-Reported Outcome Measurement Information System Global Health (PROMIS GH) scale score before and after TIA. A change of 5 or more points in this score is considered clinically relevant. The secondary outcomes included change in patient-reported global health by clinical impression of the probability of a TIA event, pattern of neurological deficits, and short-term risk of stroke, as assessed by the ABCD2 score. Results: Among 263 patients who experienced TIA, mean (SD) age was 67.9 (13.4) years and 138 (52.5%) were women. The median (interquartile range) time between patient-reported global health scores was 152 (94-284) days. Mean (SD) baseline patient-reported global physical health and mental health scale summary scores were 43.4 (8.2) and 47.7 (9.7), respectively, and were statistically significantly decreased compared with the general population mean (SD) scores of 50 (10; P < .001) for physical and mental health. The difference between physical health summary score among study participants and the general population was clinically relevant. Mean (SD) summary scores were not statistically significantly different after the event compared with before the event overall (physical health: 44.1 [8.2], for a mean [SE] improvement of 0.65 [0.38] points; P = .09; mental health: 47.4 [9.1], for a mean [SE] worsening of 0.25 [0.38] points; P = .51) or within subgroups. Conclusions and Relevance: These findings suggest that impaired health status among patients diagnosed with TIA reflect, at least in part, an impaired premorbid state of health. This study did not find that TIA events were associated with worsening of health status overall or within subgroups.

Group-level analyses involving scores linked from legacy scales to PROMIS scales: A novel alternative using imputation.

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. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Somatic symptoms have negligible impact on Patient Health Questionnaire-9 depression scale scores in neurological patients.

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.

Patient-Reported Outcomes Predict Future Emergency Department Visits and Hospital Admissions in Patients With Stroke.

Background Identification of stroke patients at increased risk of emergency department (ED) visits or hospital admissions allows implementation of mitigation strategies. We evaluated the ability of the Patient-Reported Outcomes Information Measurement System (PROMIS) patient-reported outcomes (PROs) collected as part of routine care to predict 1-year emergency department (ED) visits and admissions when added to other readily available clinical variables. Methods and Results This was a cohort study of 1696 patients with ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, or transient ischemic attack seen in a cerebrovascular clinic from February 17, 2015, to June 11, 2018, who completed the following PROs at the visit: Patient Health Questionnaire-9, Quality of Life in Neurological Disorders cognitive function, PROMIS Global Health, sleep disturbance, fatigue, anxiety, social role satisfaction, physical function, and pain interference. A series of logistic regression models was constructed to determine the ability of models that include PRO scores to predict 1-year ED visits and all-cause and unplanned admissions. In the 1 year following the PRO encounter date, 1046 ED visits occurred in 548 patients; 751 admissions occurred in 453 patients. All PROs were significantly associated with future ED visits and admissions except PROMIS sleep. Models predicting unplanned admissions had highest optimism-corrected area under the curve (range, 0.684-0.724), followed by ED visits (range, 0.674-0.691) and then all-cause admissions (range, 0.628-0.671). PROs measuring domains of mental health had stronger associations with ED visits; PROs measuring domains of physical health had stronger associations with admissions. Conclusions PROMIS scales improve the ability to predict ED visits and admissions in patients with stroke. The differences in model performance and the most influential PROs in the prediction models suggest differences in factors influencing future hospital admissions and ED visits.

The validity of proxy responses on patient-reported outcome measures: Are proxies a reliable alternative to stroke patients' self-report?

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.

Magnitude and Variability of Stroke Patient-Proxy Disagreement Across Multiple Health Domains.

OBJECTIVES: To quantify the extent and variability of bias introduced when caregivers, or proxies, complete patient-reported outcome measures (PROM) on behalf of stroke patients. DESIGN: Cross-sectional survey study conducted between July 2018 and November 2019. SETTING: Ambulatory clinic of a cerebrovascular center or rehabilitation unit. PARTICIPANTS: A consecutive sample of stroke patients (N=200) and their proxies who were able and willing to complete PROMs. Proxies completed PROMs as they believed the patient would answer. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: PROMs included Neuro-QoL cognitive function, PROMIS physical function, social role satisfaction, anxiety, fatigue, pain interference, sleep disturbance, Patient Health Questionnaire-9 translated to PROMIS Depression, and PROMIS Global Health. RESULTS: The study included 200 stroke patients (age, 62.2±13.3; 41.5% women) and their proxies (age 56.5±13.9; 70% women, 72% spouses). Proxies reported worse functioning and more symptoms across all PROM domains compared with patients (average difference, 0.3-3.0 T score points). Reliability between dyad responses was moderate across all domains (intraclass correlation coefficients (2,1), 0.49-0.76) and effect sizes were small (d=0.04-0.35). Cognitive function, anxiety, and depression had the lowest agreement, whereas physical function, pain, and sleep had the highest agreement based on the Bland-Altman method. At the individual level, a large proportion of dyads had meaningfully different scores across domains (range, 40%-57%; dyads differed >5 T score points). Few predictors of disagreement were identified through multinomial regression models. CONCLUSIONS: At the aggregate level, small differences were detected between stroke patient-proxy pairs, with lower agreement on more subjective domains. At the individual level, a large proportion of dyads reported meaningfully different scores on all domains, affecting the interpretability of proxy responses on PROMs in a clinical setting.