Patient-Reported Outcomes Measurement Information System Anxiety Research Articles

Moderation Effects of Daily Behavior on Associations between Symptoms and Social Participation Outcomes after Burn Injury: A 6-month Digital Phenotyping Study

To examine the moderation effects of daily behavior on the associations between symptoms and social participation outcomes after burn injury DESIGN: A 6-month prospective cohort study SETTING: Community PARTICIPANTS: 24 adult burn survivors INTERVENTIONS: Not applicable MAIN OUTCOME MEASURES: Symptoms and social participation outcomes were assessed weekly using smartphone surveys, including symptoms of pain (Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity and Pain Interference), anxiety (PROMIS Anxiety), and depression (Patient Health Questionnaire (PHQ-8)), as well as outcomes of social interactions and social activities (Life Impact Burn Recovery Evaluation (LIBRE) Social Interactions and Social Activities). Daily behaviors were automatically recorded by a smartphone application and smartphone logs, including physical activity (steps, travel miles, and activity minutes), sleep (sleep hours), and social contact (number of phone call and message contacts). Multilevel models controlling for demographic and burn injury variables examined the associations between symptoms and social participation outcomes, and the moderation effects of daily behaviors. Lower (worse) LIBRE Social Interactions and LIBRE Social Activities scores were significantly associated with higher (worse) PROMIS Pain Intensity, PROMIS Pain Interference, PROMIS Anxiety, and PHQ-8 scores (p<0.05). Additionally, daily steps and activity minutes were associated with LIBRE Social Interactions and LIBRE Social Activities (p<0.05), and significantly moderated the association between PROMIS Anxiety and LIBRE Social Activities (p<0.001). Social participation outcomes are associated with pain, anxiety, and depression symptoms after burn injury, and are buffered by daily physical activity. Future interventions studies should examine physical activity promotion on improving social recovery after burns.

Preoperative opioid use is associated with worse two-year patient-reported outcomes after hand surgery: A retrospective cohort study

IntroductionOpioid overprescribing has caused a substantial increase in opioid related deaths and billions of dollars in additional healthcare costs. Orthopaedic surgeons commonly prescribe opioids in the perioperative period; however, research has shown preoperative opioid use may be associated with worse postoperative outcomes. Despite this body of evidence, there are few studies investigating the association between preoperative opioid use and two-year outcomes after hand surgery. Materials and methodsThis study evaluated two-year postoperative patient-reported outcomes in patients who used opioids prior to hand surgery, and those who did not. Patients completed pre and postoperative questionnaires including Patient-Reported Outcomes Measurement Information System (PROMIS) domains, the Brief Michigan Hand Questionnaire (BMHQ), and other questionnaires related to pain, function, and satisfaction. 342 patients undergoing upper-extremity surgery were enrolled into a prospective orthopaedic surgery outcome registry, and 69.9% completed the follow-up surveys. Preoperative opioid use and its association to patient outcome scores was analyzed through bivariate analysis. Significant associations were further tested by multivariable analysis to determine independent predictors. ResultsPreoperative opioid use was associated with worse two-year PROMIS Fatigue (p ​< ​.01), PROMIS Anxiety (p ​< ​.01), PROMIS Depression (p ​< ​.01), SSQ-8 (p ​= ​.01), BMHQ (p ​= ​.01), NPS Hand (p ​< ​.01) and MODEMS met expectations (p ​= ​.03). No significant differences were observed in patient-reported outcome change scores. Multivariable analysis demonstrated that preoperative opioid use was predictive of worse two-year PROMIS Fatigue (p ​< ​.01), PROMIS Anxiety (p ​< ​.01), PROMIS Depression (p ​= ​.02), BMHQ (p ​= ​.01), SSQ-8 (p ​< ​.01), NPS Hand (p ​= ​.02) and MODEMS met expectations (p ​< ​.01). ConclusionPreoperative opioid use was associated with worse patient-reported outcomes two years after elective hand surgery. There was no significant difference in the improvement from baseline between the two groups. Clinically significant differences were observed in follow-up PROMIS Anxiety, BMHQ and NPS – Hand scores. Clinically significant change scores were noted in both groups for PROMIS PF, PROMIS PI, PROMIS SS, BMHQ, and NPS – Hand.

Association between opioid utilization and patient reported outcome measures following lumbar spine surgery

BACKGROUND CONTEXTThe patient-reported outcomes measurement information system (PROMIS), created by the National institute of Health, is a reliable and valid survey for patients with lumbar spine pathology. Preoperative opioid use has been shown to be an important predictor variable of self-reported health status in legacy patient reported outcome measures. PURPOSETo investigate the impact of chronic preoperative opiate use on PROMIS survey scores. STUDY DESIGNRetrospective database analysis. PATIENT SAMPLEBetween March 2019 and November 2021, 227 patients underwent lumbar decompression ± ≤ 2 level fusion. Fifty-seven patients (25.11%) had chronic preoperative opioid use. OUTCOME MEASURESOswestry disability index (ODI) and PROMIS survey scores. METHODSA retrospective analysis of a prospectively maintained single center patient-reported outcome database was performed with a minimum of 2 year follow-up. PROMIS Anxiety, Depression, Fatigue, Pain Interference (PI), Physical Function (PF), Sleep disturbance (SD), and Social Roles (SR) surveys were recorded at preoperative intake with subsequent follow-up at 6, 12, and 24 months postoperatively. Patients were grouped into chronic opioid users as defined by >6-month duration of use. Differences in mean survey scores were evaluated using Welch t-tests. RESULTSTwo hundred and twenty-seven patients met our inclusion criteria of completed PROMIS surveys at the designated timepoints. A total of 57 (25.11%) were chronic opioid users (COU) prior to surgery. Analysis of patient-reported health outcomes shows that long term opioid use correlated with worse ODI and PROMIS scores at baseline compared to nonchronic users (NOU). At 1 and 2 year follow-up, the COU cohort continued to have significantly worse ODI, PROMIS Fatigue, PF, PI, SD, and SR scores. There is a statistical difference in the magnitude of change in health status between the 2 cohorts at 1 year follow-up in PROMIS Depression (-5.04±7.88 vs. -2.49±8.73, p=.042), PF (6.25±7.11 vs. 9.03±9.04, p=.019), and PI (-7.40±7.37 vs. -10.58±9.87, p=.011) and 2 year follow-up in PROMIS PF (5.58±6.84 vs. 7.99±9.64, p=.041) and PI (-6.71±8.32 vs. -9.62±10.06, p=.032). Mean improvement in PROMIS scores for the COU cohort at 2 year follow-up exceeded minimal clinically important difference (MCID) in all domains except PROMIS Depression, SR and SD. CONCLUSIONPatients with chronic opioid use status have worse baseline PROMIS scores compared with patients who had nonchronic use. However, patients in the COU cohort displayed clinically significant postoperative improvement in multiple PROMIS domains. These results show that patients with chronic opioid use can benefit greatly from surgical intervention and will allow physicians to better set expectations with their patients.

Improvements in Physical Function and Pain Interference and Changes in Mental Health Among Patients Seeking Musculoskeletal Care

Among patients seeking care for musculoskeletal conditions, there is mixed evidence regarding whether traditional, structure-based care is associated with improvement in patients' mental health. To determine whether improvements in physical function and pain interference are associated with meaningful improvements in anxiety and depression symptoms among patients seeking musculoskeletal care. This cohort study included adult patients treated by an orthopedic department of a tertiary care US academic medical center from June 22, 2015, to February 9, 2022. Eligible participants presented between 4 and 6 times during the study period for 1 or more musculoskeletal conditions and completed Patient-Reported Outcomes Measurement Information System (PROMIS) measures as standard care at each visit. PROMIS Physical Function and Pain Interference scores. Linear mixed effects models were used to determine whether improvements in PROMIS Anxiety and PROMIS Depression scores were associated with improved PROMIS Physical Function or Pain Interference scores after controlling for age, gender, race, and PROMIS Depression (for the anxiety model) or PROMIS Anxiety (for the depression model). Clinically meaningful improvement was defined as 3.0 points or more for PROMIS Anxiety and 3.2 points or more for PROMIS Depression. Among 11 236 patients (mean [SD] age, 57 [16] years), 7218 (64.2%) were women; 120 (1.1%) were Asian, 1288 (11.5%) were Black, and 9706 (86.4%) were White. Improvements in physical function (β = -0.14; 95% CI, -0.15 to -0.13; P < .001) and pain interference (β = 0.26; 95% CI, 0.25 to 0.26; P < .001) were each associated with improved anxiety symptoms. To reach a clinically meaningful improvement in anxiety symptoms, an improvement of 21 PROMIS points or more (95% CI, 20-23 points) on Physical Function or 12 points or more (95% CI, 12-12 points) on Pain Interference would be required. Improvements in physical function (β = -0.05; 95% CI, -0.06 to -0.04; P < .001) and pain interference (β = 0.04; 95% CI, 0.04 to 0.05; P < .001) were not associated with meaningfully improved depression symptoms. In this cohort study, substantial improvements in physical function and pain interference were required for association with any clinically meaningful improvement in anxiety symptoms, and were not associated with any meaningful improvement in depression symptoms. Patients seeking musculoskeletal care clinicians providing treatment cannot assume that addressing physical health will result in improved symptoms of depression or potentially even sufficiently improved symptoms of anxiety.

Safety and Efficacy of Lebrikizumab in Adolescent Patients with Moderate-to-Severe Atopic Dermatitis: A 52-Week, Open-Label, Phase 3 Study.

Atopic dermatitis (AD) is a chronic inflammatory skin disorder with limited treatment options for adolescents with moderate-to-severe disease. Lebrikizumab, a monoclonal antibody targeting interleukin (IL)-13, demonstrated clinical benefit in previous Phase 3 trials: ADvocate1 (NCT04146363), ADvocate2 (NCT04178967), and ADhere (NCT04250337). We report 52-week safety and efficacy outcomes from ADore (NCT04250350), a Phase 3, open-label study of lebrikizumab in adolescent patients with moderate-to-severe AD. The primary endpoint was to describe the proportion of patients who discontinued from study treatment because of adverse events (AEs) through the last treatment visit. Adolescent patients (N = 206) (≥ 12 to < 18years old, weighing ≥ 40kg) with moderate-to-severe AD received subcutaneous lebrikizumab 500mg loading doses at baseline and Week 2, followed by 250mg every 2weeks (Q2W) thereafter. Safety was monitored using reported AEs, AEs leading to treatment discontinuation, vital signs, growth assessments, and laboratory testing. Efficacy analyses included Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body Surface Area (BSA), (Children's) Dermatology Life Quality Index ((C)DLQI), and Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety, and PROMIS Depression. 172 patients completed the treatment period. Low frequencies of SAEs (n = 5, 2.4%) and AEs leading to treatment discontinuation (n = 5, 2.4%) were reported. Overall, 134 patients (65%) reported at least one treatment-emergent AE (TEAE), most being mild or moderate in severity. In total, 62.6% achieved IGA (0,1) with ≥2-point improvement from baseline and 81.9% achieved EASI-75 by Week 52. The EASI mean percentage improvement from baseline to Week 52 was 86.0%. Mean BSA at baseline was 45.4%, decreasing to 8.4% by Week 52. Improvements in mean change from baseline (CFB) to Week 52 were observed in DLQI (baseline 12.3; CFB - 8.9), CDLQI (baseline 10.1; CFB - 6.5), PROMIS Anxiety (baseline 51.5; CFB - 6.3), and PROMIS Depression (baseline 49.3; CFB - 3.4) scores. Lebrikizumab 250mg Q2W had a safety profile consistent with previous trials and significantly improved AD symptoms and quality of life, with meaningful responses at Week 16 increasing by Week 52. ClinicalTrials.gov identifier, NCT04250350.

116 Relationship between Smartphone-tracked Physical Activities and Psychosocial Outcomes for Burn Survivors Living in the Community

Abstract Introduction Following burn survivors in the community is critical to understand their problems and needs. Physical activities automatically recorded by smartphones have shown to be a convenient and burdenless method for post-discharge assessment. However, it is unclear if physical activities are associated with burn survivors’ physical and psychosocial outcomes. This study aims to examine the relationship between smartphone-tracked physical activities and scale-based outcomes. Methods Adult burn survivors living in the community were included in this study. A mobile application was downloaded to participants’ smartphones and automatically recorded daily number of steps, travel miles and activity minutes. Participants received weekly surveys assessing pain (Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity and Interference), depression (Patient Health Questionnaire (PHQ-8)), anxiety (PROMIS Anxiety) and social participation (Life Impact Burn Recovery Evaluation (LIBRE) Social Interactions and Social Activities). Correlation coefficients between physical activities and survey results were examined and interpreted as “very weak” (|r|≤0.19), “weak” (0.20≤|r|≤0.39), “moderate” (0.40≤|r|≤0.59), “strong” (0.60≤|r|≤0.79), and “very strong” (0.80≤|r|≤1.00). Results There were 24 burn survivors with an average of 24 years after injury included in this study. The 180-week data collected between November 2021 and August 2022 was analyzed. Daily number of steps, travel miles and activity minutes separately showed relationships with PROMIS Pain Intensity (r=-0.312, p&amp;lt; 0.001; r=-0.247, p=0.001; r=-0.239, p=0.001), PROMIS Pain Interference (r=-0.375, p&amp;lt; 0.001; r=-0.318, p&amp;lt; 0.001; r=-0.291, p&amp;lt; 0.001), PHQ-8 (r=-0.403, p&amp;lt; 0.001; r=-0.357, p&amp;lt; 0.001; r=-0.311, p&amp;lt; 0.001), PROMIS Anxiety (r=-0.310, p&amp;lt; 0.001; r=-0.209, p=0.007; r=-0.150, p=0.054), LIBRE Social Interactions (r=0.272, p&amp;lt; 0.001; r=0.291, p&amp;lt; 0.001; r=0.328, p&amp;lt; 0.001) and LIBRE Social Activities (r=0.381, p&amp;lt; 0.001; r=0.414, p&amp;lt; 0.001; r=0.404, p&amp;lt; 0.001). Conclusions Daily number of steps demonstrated a moderate correlation with depression while both daily travel miles and activity minutes showed moderate correlations with social participation. The results support that smartphone-tracked physical activities are related to burn survivors’ psychosocial outcomes. Applicability of Research to Practice This study may inform future use of smartphone-tracked physical activities to understand and track burn recovery and ultimately improve care.

Impact of Sleep Disturbance on Clinical Outcomes in Lumbar Decompression.

To examine the impact of Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (PROMIS-SD) on clinical outcomes in patients undergoing lumbar decompression. Patients undergoing lumbar decompression with preoperative PROMIS-SD scores were retrospectively included. Patients were separated into 2 cohorts: none to slight sleep disturbance (PROMIS-SD <55) and mild to severe sleep disturbance (PROMIS-SD ≥55). Patient-reported outcome measures including PROMIS Physical Function, PROMIS Anxiety, PROMIS Pain Interference, PROMIS SD, 9-item Patient Health Questionnaire, visual analog scale back/leg, and Oswestry Disability Index were collected preoperatively and up to 1 year postoperatively. Of 87 patients identified, 48 patients had PROMIS-SD scores ≥55. Regardless of preoperative PROMIS-SD score, patients reported significant improvement in physical function, anxiety, pain interference, depression, pain, and disability outcomes in at least 1 time point. Patients in the PROMIS-SD ≥55 cohort reported postoperative improvement in sleep disturbance. Patients in the PROMIS-SD <55 cohort reported superior preoperative patient-reported outcome measures in all domains and superior postoperative improvement in pain interference and sleep disturbance. Minimum clinically important difference attainment rates were higher in the PROMIS-SD ≥55 cohort in physical function, anxiety, pain interference, sleep disturbance, and pain. Patients undergoing lumbar decompression demonstrated significant postoperative improvement in most clinical outcomes regardless of preoperative sleep disturbance. Patients with mild to severe sleep disturbance had higher minimum clinically important difference attainment rates for physical function, mental function, and pain. Patients undergoing lumbar decompression with greater preoperative sleep disturbance may experience more clinically noticeable improvement.

Impact of body mass index on PROMIS outcomes following lumbar decompression.

No studies have examined the impact of body mass index (BMI) on newer Patient-Reported Outcomes Measurement Information System (PROMIS) outcomes in patients undergoing lumbar decompression (LD). Patients undergoing LD with preoperative PROMIS measures were stratified into four cohorts: normal (18.5 ≤ BMI < 25kg/m2), overweight (25 ≤ BMI < 30kg/m2), obese I (30 ≤ BMI < 35kg/m2), and obese II-III (BMI ≥ 35kg/m2). Demographics, perioperative characteristics, and patient-reported outcomes (PROs) were obtained. PROs of PROMIS Physical Function (PROMIS-PF), PROMIS Anxiety (PROMIS-A), PROMIS Pain Interference (PROMIS-PI), PROMIS Sleep Disturbance (PROMIS-SD), Patient Health Questionnaire-9 (PHQ-9), Visual Analog Scale (VAS) Back Pain (VAS-BP), VAS Leg Pain (VAS-LP), and Oswestry Disability Index (ODI) were collected at preoperative and up to 2-year postoperative time points. Minimum clinically important difference (MCID) achievement was determined through comparison of previously established values. Comparison between cohorts were determined through inferential statistics. A total of 473 patientswere identified, with stratification of 125 patients in the normal cohort, 161 in the overweight cohort, 101 in the obese I cohort, and 87 in the obese II-III cohort. Mean postoperative follow-up time was 13.51 ± 8.72months. Higher BMI patients had higher operative times, longer postoperative length of stay, and greater narcotic consumption (p ≤ 0.001, all). Patients with higher BMI (obese I, obese II-III) reported inferior preoperative PROMIS-PF, VAS-BP, and ODI scores (p ≤ 0.003, all). Postoperatively, obese I-III cohorts demonstrated inferior PROMIS-PF, PHQ-9, VAS-BP, and ODI scores at final follow-up (p ≤ 0.016, all). However, patients demonstrated similar postoperative changes and MCID achievement regardless of preoperative BMI. Patients undergoing lumbar decompression demonstrated similar postoperative improvement in physical function, anxiety, pain interference, sleep disturbance, mental health, pain, and disability outcomes independent of preoperative BMI. However, obese patients reported worse physical function, mental health, back pain, and disability outcomes at final postoperative follow-up. Patients with greater BMI undergoing lumbar decompression demonstrate inferior postoperative clinical outcomes.

Did the Physical and Mental Health of Orthopaedic Patients Change After the Onset of the COVID-19 Pandemic?

Did the Physical and Mental Health of Orthopaedic Patients Change After the Onset of the COVID-19 Pandemic?

Pain Interference Influence on Postoperative Clinical Trajectory in Patients Undergoing Lumbar Decompression

Newer Patient-Reported Outcomes (PROs) may offer benefits over legacy PROs in ease of administration and interpretation. We aim to study the influence of preoperative pain interference (PI) using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PROMIS-PI) on postoperative clinical outcomes in patients undergoing lumbar decompression. Patients undergoing lumbar decompression without fusion were separated into 2 cohorts: PROMIS-PI < 64 (lesser PI) and PROMIS-PI ≥ 64 (greater PI). PROs included PROMIS physical function, PROMIS anxiety (PROMIS-A), PROMIS sleep disturbance (PROMIS-SD), PROMIS-PI, Patient Health Questionnaire-9, Visual Analog Scale (VAS) back, VAS leg, and Oswestry Disability Index (ODI) and were collected at preoperative and postoperative time points. Demographics, perioperative characteristics, PROs, and Minimum Clinically Important Difference (MCID) were compared among groups through non-parametric inferential statistics. One-hundred and seven patients were identified. Independent of preoperative PI, patients reported significant postoperative improvement in PROMIS physical function, PROMIS-A, PROMIS-PI, VAS back, VAS leg, and ODI. The greater PI cohort reported significant postoperative improvement in Patient Health Questionnaire-9 and PROMIS-SD. The lesser PI cohort reported superior preoperative PROs in all domains. Postoperatively, the lesser PI cohort reported superior 6-week PROMIS-A and PROMIS-SD. MCID achievement rates were higher in the greater PI cohort for PROMIS-PI, VAS back, VAS leg, and ODI. Patients with lower preoperative PI reported superior postoperative anxiety and sleep disturbance. Patients with greater preoperative PI had higher MCID achievement rates in PI, pain, and disability. Patients with greater preoperative PI undergoing lumbar decompression may demonstrate higher rates of clinically tangible improvement.

Unique characteristics of patients who choose an intensive lifestyle medicine program to address chronic musculoskeletal pain.

Factors that motivate musculoskeletal patients to pursue an intensive, lifestyle medicine-based approach to care are poorly understood. To determine whether, compared to patients seeking musculoskeletal care through traditional pathways, patients who choose an intensive lifestyle medicine program for musculoskeletal pain endorse greater physical dysfunction, worse psychological health, and/or more biopsychosocial comorbidities. Cross-sectional analysis of existing medical records from 2018 to 2021. Orthopedic department of one academic medical center. Fifty consecutive patients who enrolled in an intensive lifestyle medicine program to address a musculoskeletal condition. Comparison groups were the following: (1) 100 patients who presented for standard nonoperative musculoskeletal care, and (2) 100 patients who presented for operative evaluation by an orthopedic surgeon and qualified for joint arthroplasty. Not applicable. Primary outcomes were age-adjusted, between-group differences in Patient-Reported Outcomes Measurement Information System (PROMIS) physical and psychological health measures. Secondary outcomes were between-group differences in sociodemographic and medical history characteristics. Patients who enrolled in the intensive lifestyle medicine program were more racially diverse (non-White race: lifestyle cohort 34% vs. comparison cohorts 16%-18%, p ≤ .029) and had a higher prevalence of obesity and diabetes than both comparison groups (mean body mass index: lifestyle cohort 37.6kg/m2 vs. comparison cohorts 29.3-32.0, p < .001; diabetes prevalence: lifestyle cohort 32% vs. comparison cohorts 12%-16%, p ≤ .024). Compared to standard nonoperative patients, there were no clear between-group differences in PROMIS physical or psychological health scores. Compared to standard operative evaluation patients, patients in the lifestyle program reported worse anxiety but less pain interference (PROMIS Anxiety: B=3.8 points [95% confidence interval, 0.1 to 7.4], p=.041; Pain interference: B=-3.6 [-6.0 to -1.2], p=.004). Compared to musculoskeletal patients who sought care through traditional pathways, patients who chose an intensive lifestyle medicine pathway had a higher prevalence of metabolic comorbidities, but there was substantial overlap in patients' physical, psychological, and sociodemographic characteristics.

Construct Validity of Pediatric PROMIS Computerized Adaptive Testing Measures in Children With Adolescent Idiopathic Scoliosis.

The use of patient-reported outcome measures, especially Patient-Reported Outcomes Measurement Information System (PROMIS) measures, has increased in recent years. Given this growth, it is imperative to ensure that the measures being used are validated for the intended population(s)/disease(s). Our objective was to assess the construct validity of 8 PROMIS computer adaptive testing (CAT) measures among children with adolescent idiopathic scoliosis (AIS). We prospectively enrolled 200 children (aged 10 to 17 y) with AIS, who completed 8 PROMIS CATs (Anxiety, Depressive Symptoms, Mobility, Pain Behavior, Pain Interference, Peer Relationships, Physical Activity, Physical Stress Experiences) and the Scoliosis Research Society-22r questionnaire (SRS-22r) electronically. Treatment categories were observation, bracing, indicated for surgery, or postoperative from posterior spinal fusion. Construct validity was evaluated using known group analysis and convergent and discriminant validity analyses. Analysis of variance was used to identify differences in PROMIS T -scores by treatment category (known groups). The Spearman rank correlation coefficient ( rs ) was calculated between corresponding PROMIS and SRS-22r domains (convergent) and between unrelated PROMIS domains (discriminant). Floor/ceiling effects were calculated. Among treatment categories, significant differences were found in PROMIS Mobility, Pain Behavior, Pain Interference, and Physical Stress Experiences and in all SRS-22r domains ( P <0.05) except Mental Health ( P =0.15). SRS-22r Pain was strongly correlated with PROMIS Pain Interference ( rs =-0.72) and Pain Behavior ( rs =-0.71) and moderately correlated with Physical Stress Experiences ( rs =-0.57). SRS-22r Mental Health was strongly correlated with PROMIS Depressive Symptoms ( rs =-0.72) and moderately correlated with Anxiety ( rs =-0.62). SRS-22r Function was moderately correlated with PROMIS Mobility ( rs =0.64) and weakly correlated with Physical Activity ( rs =0.34). SRS-22r Self-Image was weakly correlated with PROMIS Peer Relationships ( rs =0.33). All unrelated PROMIS CATs were weakly correlated (| rs |<0.40). PROMIS Anxiety, Mobility, Pain Behavior, and Pain Interference and SRS-22r Function, Pain, and Satisfaction displayed ceiling effects. Evidence supports the construct validity of 6 PROMIS CATs in evaluating AIS patients. Ceiling effects should be considered when using specific PROMIS CATs. Level II, prognostic.

Association of modifiable factors with financial burden and health literacy among patients with cancer.

6573 Background: Cancer patients are at a higher risk of financial burden compared to those with other chronic illnesses and those without cancer. Additionally, cancer patients with low health literacy are at risk for poor health outcomes and poor self-management. Aside from factors such as education and insurance, there is limited information on the role of modifiable factors in predicting financial burden and health literacy. The aim of this study was to identify risk factors associated with financial burden and health literacy among cancer patients. Methods: Participants were 2,260 adult, English- or Spanish-speaking patients who were recruited from an NCI-designated cancer center in the Chicagoland area as part of a trial on symptom management. Participants completed measures on depressive symptoms and anxiety using the Patient-Reported Outcomes Measurement Information System (PROMIS). Financial burden was assessed using a Comprehensive Score for Financial Toxicity (COST FACIT) item (FT12) and health literacy was assessed by the Single Item Literacy Screener (SILS). Additional information on insurance and cancer diagnosis were extracted from medical records. The area deprivation index (ADI) was calculated using national percentile rankings for the patient’s block group. All patient-reported outcomes were assessed at study baseline. Cross-sectional logistic regression models were fit with the FT12 item [dichotomized as high (somewhat/quite a bit/very much) vs. low (not at all/a little bit) financial burden] and SILS [dichotomized as high (quite a bit/extremely) vs. low (not at all/a little bit/somewhat) health literacy] as separate outcomes. The primary covariates of interest were anxiety and depressive symptoms T-scores (dichotomized reflect normal limits vs. elevated distress). Analyses were adjusted for socio-demographic and clinical characteristics. Results: After adjusting for covariates, significant associations of greater financial burden were PROMIS depression [odds ratio (OR): 1.63 (95% CI: 1.22-2.19)] and PROMIS anxiety (OR: 1.60; 95% CI: 1.22-2.10). In addition, higher ADI score, lower education, unemployment, and low health literacy were significantly associated with greater financial burden. PROMIS depression (OR: 2.15; 95% CI: 1.38-3.40) was associated with low heath literacy, along with disability/leave of absence, Medicare/Medicaid/uninsured and lower education. Conclusions: Modifiable factors are associated with financial burden and health literacy. These results support the systematic screening for financial burden and health literacy in addition emotional well-being. Interventions targeting the modifiable factors elucidated in this study may further efforts to provide quality and equitable comprehensive cancer care. Future work should evaluate the potential causal pathways between depression, health literacy, and financial burden.

An Exploratory Factor Analysis of the National Institutes of Health Patient-Reported Outcomes Measurement Information System and the Single Assessment Numeric Evaluation in Knee Surgery Patients.

Patient-Reported Outcomes (PROs) have been suggested for use in measuring treatment effectiveness. To minimize patient burden, two approaches have been proposed: An orthopedic-specific Single Assessment Numeric Evaluation (SANE) or computer adaptive testing methods such as the National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS). The goal of this work was to examine the constructs measured by the SANE and PROMIS system in a military orthopedic population undergoing knee surgery. In 732 patients and 2,166 complete observations, the SANE-Knee PRO and PROMIS surveys for Depression, Anxiety, Pain Interference, Sleep Disturbance, and Physical Function were obtained. A correlation matrix between the PROs was calculated, the number of latent factors to extract was determined via parallel plot, and the final principal axis exploratory factor analysis was performed. The parallel plot analysis indicated that two latent factors existed. One latent factor corresponded to measures of psychological distress (PROMIS Sleep Disturbance, Depression, and Anxiety) and the second latent factor corresponded to physical capability (SANE, PROMIS Physical Function, Pain Interference, and Sleep Disturbance). Both PROMIS Physical Function (0.83) and Pain Interference (-0.80) more strongly weigh on the physical capability latent factor than SANE (0.69). In a knee surgical population, the SANE, PROMIS Physical Function, and PROMIS Pain Interference measure the same human dimension of physical capability; however, PROMIS Physical Function and Pain Interference may measure this construct more effectively in isolation. The SANE may be a more viable option to gauge physical capability when computer adaptive testing is not possible.

Evaluation of the Pathways for Survivors Program to Address Breast Cancer Survivorship-Associated Distress: Survey Study.

BackgroundPatients with breast cancer frequently experience escalation of anxiety after completing curative treatment.ObjectiveThis study evaluated the acceptability and psychological impact of a 1-day workshop to emphasize behavioral strategies involving intention and self-efficacy.MethodsBreast cancer survivors who attended a 1-day Pathways for Survivors workshop provided feedback and completed electronic quality of life (QOL) questionnaires at baseline, 1 and 6 weeks, and 6 months after the workshop. Attendees’ baseline QOL scores were compared to follow-up (FUP) scores. Scores from patients receiving routine FUP care were also compiled as a reference population.ResultsIn total, 77 patients attended 1 of 9 workshops. The mean satisfaction score was 9.7 out of 10 for the workshop and 9.96 out of 10 for the moderator. Participants’ baseline mean Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety and depression scores were 57.8 (SD 6.9) and 55.3 (SD 7.5), respectively, which were significantly higher than those of patients receiving routine FUP care (49.1, SD 8.3 and 47.3 SD 8.0, respectively). PROMIS anxiety and depression scores decreased, and the Happiness Index Profile (HIP-10) score—measuring intention and resiliency—increased significantly at 1- and 6-week FUPs.ConclusionsThe Pathways for Survivors program was favorably received. Anxiety and depression decreased significantly at 1- and 6-weeks after the workshop and remained below baseline at 6 months. Increased HIP-10 scores suggest that patients acquired and implemented skills from the workshop. A 1-day workshop led by a lay moderator significantly improved several psychological measures, suggesting that it may be a useful and time-efficient strategy to improve QOL in breast cancer survivors. We are investigating whether an abbreviated “booster” of the intervention at a later date could further improve and maintain QOL gains.

Pediatric hematology/oncology healthcare professional emotional health during COVID-19.

ObjectivesLittle is known about the impact of coronavirus disease 2019 (COVID‐19) on healthcare professional emotional health in pediatric hematology/oncology. Primary objective was to describe anxiety, depression, positive affect, and perceived stress among pediatric hematology/oncology healthcare professionals following a COVID‐19 outbreak. Secondary objectives were to compare these outcomes based on contact with a positive person, and to identify risk factors for worse outcomes.Materials and methodsWe included 272 healthcare professionals working with pediatric hematology/oncology patients. We determined whether respondents had direct or indirect contact with a COVID‐19‐positive individual and then measured outcomes using the Patient‐Reported Outcomes Measurement Information System (PROMIS) depression, anxiety, and positive affect measures, and the Perceived Stress Scale.ResultsAmong eligible respondents, 205 agreed to participate (response rate 75%). Sixty‐nine (33.7%) had contact with a COVID‐19‐positive person. PROMIS anxiety, depression, and positive affect scores were similar to the general United States population. Those who had contact with a COVID‐19‐positive individual did not have significantly different outcomes. In multiple regression, non‐physicians had significantly increased anxiety (nurses: p = 0.013), depression (nurses: p = 0.002, pharmacists: p = 0.038, and other profession: p = 0.021), and perceived stress (nurses: p = 0.002 and other profession: p = 0.011) when compared to physicians.ConclusionsPediatric hematology/oncology healthcare professionals had similar levels of anxiety, depression, and positive affect as the general population. Contact with a COVID‐19‐positive individual was not significantly associated with outcomes. Non‐physician healthcare professionals had more anxiety, depression, and perceived stress when compared to physicians. These findings may help to develop programs to support healthcare professional resilience.

Latent Factor Analysis of the PROMIS and Single Assessment Numeric Evaluation in Patients Undergoing Shoulder Surgery.

Patient-reported outcomes (PROs) are reporting tools that quantify patients' perceptions of their mental and physical health. Many PROs may inadvertently measure the same or overlapping theoretical constructs (e.g., pain, function, depression, etc.), which is both inefficient and a patient burden. The purpose of this study was to examine the functional relationship of the Single Assessment Numeric Evaluation (SANE) score and general constructs measured with the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) in young patients undergoing shoulder surgery. This study was an institutional review board approved retrospective case control of the Military Orthopaedics Tracking Injuries and Outcomes Network using 805 patients and 1,373 observations. All patients underwent shoulder surgery and had multiple observations ranging from 28 days pre-surgery to 428 days post-surgery. Correlation matrices and exploratory factor analysis were used to examine how each of the measured variables (PROMIS physical function, PROMIS pain interference, PROMIS sleep disturbance, PROMIS anxiety, PROMIS depression, and SANE surveys) contribute or "weigh" on latent factors, which are then mapped to a theoretical construct. This statistical method helps uncover structural relationships between measured variables. The PROMIS and SANE surveys collectively weigh on two latent factors: psychological health (measured variables: PROMIS anxiety [0.95] and PROMIS depression [0.86]) and physical capabilities (measured variables: PROMIS physical function [0.81], PROMIS pain interference [-0.82], PROMIS sleep disturbance [-0.51], and SANE [0.68]). Although the physical capability construct is functionally related to psychological health (-0.45), there is no direct relation between SANE and measures of depression or anxiety. This study supports the use of the SANE as a valid single question to assess physical function providing similar information to the PROMIS in regard to measuring physical capabilities. Its simplicity makes it easy to use and implement with minimal uplift or change in workflow.

Quality of Life Outcomes in Primary Caregivers of Children with Esophageal Atresia

To investigate the quality of life (QoL) impact on primary caregivers of children with esophageal atresia. We used a prospective cohort study design, inviting primary caregivers of children with esophageal atresia to complete the following questionnaires: Parent Experience of Child Illness (PECI), Patient-Reported OutcomesMeasurement Information System (PROMIS) Anxiety, PROMIS Depression, 12-Item Short Form Survey (SF-12), and Pediatric Quality of Life Inventory (PedsQL). The PECI, PROMIS Anxiety and Depression, and SF-12 assessed caregiver QoL, and the PedsQL assessed patient QoL. Patients with Gross type E esophageal atresia served as controls. The primary caregivers of 100 patients (64 males, 36 females; median age, 4.6years; range, 3.5months to 19.0years) completed questionnaires. The majority (76 of 100) of patients had Gross type C esophageal atresia. A VACTERL (vertebral anomalies, anorectal malformation, cardiac anomalies, tracheoesophageal fistula, renal anomalies, limb anomalies) association was found in 30, ≥1 esophageal dilatation was performed in 57, and fundoplication was performed in 11/100. When stratified by esophageal atresia types, significant differences were found in 2 PECI subscales (unresolved sorrow/anger, P=.02; uncertainty, P=.02), in PROMIS Anxiety (P=.02), and in SF-12 mental health (P=.02) and mental component summary scores (P=.02). No significant differences were found for VACTERL association, nor esophageal dilatation. Requirement for fundoplication resulted in lower SF-12 general health score, and lower PedsQL social and physical functioning scores. We have demonstrated that caring for a child with esophageal atresia and a previous requirement for fundoplication impacts caregiver QoL.

Determining validity, discriminant ability, responsiveness, and minimal clinically important differences for PROMIS in adult spinal deformity.

The aim of this study was to determine the concurrent validity, discriminant ability, and responsiveness of the Patient-Reported Outcomes Measurement Information System (PROMIS) in adult spinal deformity (ASD) and to calculate minimal clinically important differences (MCIDs) for PROMIS scores. The authors used data obtained in 186 surgical patients with ASD. Concurrent validity was determined through correlations between preoperative PROMIS scores and legacy measure scores. PROMIS discriminant ability between disease severity groups was determined using the preoperative Oswestry Disability Index (ODI) value as the anchor. Responsiveness was determined through distribution- and anchor-based methods, using preoperative to postoperative changes in PROMIS scores. MCIDs were estimated on the basis of the responsiveness analysis. The authors found strong correlations between PROMIS Pain Interference and ODI and the Scoliosis Research Society 22-item questionnaire Pain component; PROMIS Physical Function and ODI; PROMIS Anxiety and Depression domains and the 12-Item Short Form Health Survey version 2, Physical and Mental Components, Scoliosis Research Society 22-item questionnaire Mental Health component (anxiety only), 9-Item Patient Health Questionnaire (anxiety only), and 7-Item Generalized Anxiety Disorder questionnaire; PROMIS Fatigue and 9-Item Patient Health Questionnaire; and PROMIS Satisfaction with Participation in Social Roles (i.e., Social Satisfaction) and ODI. PROMIS discriminated between disease severity groups in all domains except between none/mild and moderate Anxiety, with mean differences ranging from 3.7 to 8.4 points. PROMIS showed strong responsiveness in Pain Interference; moderate responsiveness in Physical Function and Social Satisfaction; and low responsiveness in Anxiety, Depression, Fatigue, and Sleep Disturbance. Final PROMIS MCIDs were as follows: -6.3 for Anxiety, -4.4 for Depression, -4.6 for Fatigue, -5.0 for Pain Interference, 4.2 for Physical Function, 5.7 for Social Satisfaction, and -3.5 for Sleep Disturbance. PROMIS is a valid assessment of patient health, can discriminate between disease severity levels, and shows responsiveness to changes after ASD surgery. The MCIDs provided herein may help clinicians interpret postoperative changes in PROMIS scores, taking into account the fact that they are pending external validation.

Influences of health and environmental deprivation on family relationships among children with chronic disease.

Families play a key role in managing chronic illness. Among chronically ill children, we describe the Patient-Reported Outcomes Measurement Information System (PROMIS) Family Relationships measure over time and its associations with sociodemographics, environmental deprivation, and health. Parents of children aged 8-18years with asthma (n = 171), type 1 diabetes (n = 199), or sickle cell disease (n = 135), recruited in pediatric clinics and emergency departments (ED), completed demographic surveys. Every six months for up to three years, children completed PROMIS Family Relationships, Anxiety, and Depressive Symptoms short forms (T-scores; mean 50, SD = 10), and a 5-level health status item. Linear mixed models were fit to estimate associations. Older baseline age was associated with weaker family relationships. For example, for each 3-year higher baseline age, relationships were 3 points weaker for males (- 3.0; 95%CI - 5.7 to - .0.2) and females (- 3.1; 95%CI - 6.0 to - 0.3) with asthma recruited in the ED. For each 1-unit higher mean overall health, relationships were 4.6 points (95%CI 3.2-6.1) stronger for children with diabetes and about 2 points stronger for children with asthma (2.3; 0.7-3.9) and sickle cell disease (2.1; 0.3-3.9). Family relationships were 0.3-0.5 points weaker for each 1-unit increment in mean anxiety or depressive symptoms across all three diseases. Relationships were not significantly associated with environmental deprivation and generally stable over time. Family relationships were weaker among older children and generally stable over time, yet fluctuated with physical and mental health. Monitoring PROMIS Family Relationships scores may facilitate referrals for chronically ill children who need support.