Patient-Reported Outcomes Measurement Information System Sleep Disturbance Research Articles

Longitudinal Predictors of PROMIS Satisfaction With Social Roles and Activities After Shoulder and Knee Sports Orthopaedic Surgery in United States Military Servicemembers: An Observational Study.

Satisfaction with social roles and activities is an important outcome for postsurgical rehabilitation and quality of life but not commonly assessed. To evaluate longitudinal patterns of the Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction with Social Roles and Activities measure, including how it relates to other biopsychosocial factors, before and up to 6 months after sports-related orthopaedic surgery. Cohort study (diagnosis); Level of evidence, 3. Participants (N = 223) who underwent knee and shoulder sports orthopaedic surgeries between August 2016 and October 2020 completed PROMIS computer-adaptive testing item banks and pain-related measures before surgery and at 6-week, 3-month, and 6-month follow-ups. In a generalized additive mixed model, covariates included time point; peripheral nerve block; the PROMIS Anxiety, Sleep Disturbance, and Pain Behavior measures; and previous 24-hour pain intensity. Patient-reported outcomes were modeled as nonlinear (smoothed) effects. The linear (estimate, 2.06; 95% CI, 0.77-3.35; P = .002) and quadratic (estimate, 2.93; 95% CI, 1.78-4.08; P < .001) effects of time, as well the nonlinear effects of PROMIS Anxiety (P < .001), PROMIS Sleep Disturbance (P < .001), PROMIS Pain Behavior (P < .001), and pain intensity (P = .02), were significantly associated with PROMIS Satisfaction with Social Roles and Activities. The cubic effect of time (P = .06) and peripheral nerve block (P = .28) were not. The proportion of patients with a 0.5-SD improvement in the primary outcome increased from 23% at 6 weeks to 52% by 6 months postsurgery, whereas those reporting worsening PROMIS Satisfaction with Social Roles and Activities decreased from 30% at 6 weeks to 13% at 6 months. The PROMIS Satisfaction with Social Roles and Activities measure was found to be related to additional domains of function (eg, mental health, behavioral, pain) associated with postsurgical rehabilitation.

Performance of PROMIS Measures to Assess Fatigue and Sleep Symptom Severity Among African American Patients Newly Diagnosed With Obstructive Sleep Apnea.

This pilot study examined the concurrent validity of Patient-Reported Outcomes Measurement Information System (PROMIS), Short Form, measures with the longer Multidimensional Fatigue Inventory among patients living with obstructive sleep apnea (OSA). A total of 26 African American patients living with prediabetes and newly diagnosed with OSA completed the six-item short form versions of PROMIS Fatigue and PROMIS Sleep Disturbance, and the longer 20-item Multidimensional Fatigue Inventory. Both PROMIS Fatigue and Sleep Disturbance scales demonstrated high reliability with Cronbach's α of .91 and .92, respectively. PROMIS Fatigue scores were significantly correlated with Multidimensional Fatigue Inventory scores (rs = .53; p = .006) and demonstrated concurrent validity. However, PROMIS Sleep Disturbance scores and Multidimensional Fatigue Inventory scores were not associated with one another. The brief PROMIS Fatigue scale is a useful, succinct approach to assess fatigue severity among diverse patient populations living with OSA. This study is among the first to evaluate the performance of PROMIS Fatigue in a sample living with OSA.

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.

THE RELATIONSHIP BETWEEN SELF-REPORTED SLEEP, WRIST ACTIGRAPHY, AND SYMPTOMS AMONG ADULTS WITH INFLAMMATORY BOWEL DISEASE (IBD)

Abstract BACKGROUND Recently, there has been a growing recognition of the bidirectional link between sleep and inflammation. Several studies have reported the prevalence of sleep disturbances in those with Inflammatory Bowel Disease (IBD) and found poor sleep has the potential to increase the risk of disease relapse. Additionally, sleep loss may adversely affect cognitive performance, mental health, metabolism, and pain perception. While previous research has indicated potential associations between sleep and symptoms commonly reported in IBD, few studies use objective measures of sleep. Wrist actigraphy can objectively and non-invasively measure sleep-wake cycles and has been found feasible for use in the IBD population. This study aimed to examine the relationship between self-reported sleep, wrist actigraphy, and symptoms among adults with IBD. METHODS Participants with IBD (ages 18-55) completed demographic and sleep questionnaires, a 28-day symptom diary, and wore a wrist actigraph for up to 15 days. Sleep questionnaires were the Pittsburgh Sleep Quality Index (PSQI), Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance, and PROMIS sleep-related impairment. Participants rated symptoms on a 4-point Likert scale, including gastrointestinal-related symptoms such as abdominal pain, diarrhea, bloating, constipation, fatigue, and extraintestinal symptoms, including anxiety, depression, and stress. Data analysis included descriptive statistics and Pearson correlations. RESULTS Twenty-five participants (Crohn’s Disease=18; Ulcerative Colitis=7) were included. The mean age was 33.5 (SD 8.3) years of age, 60% were female, 92% were White, 88% were non-Hispanic or Latino, and 36% had active endoscopic disease. Most (64%) participants had poor quality sleep (PSQI global ≥ 5). In contrast, the averages for onset latency, efficiency, wake after sleep onset (WASO), and total sleep time were all within normal values at 17.4 min (SD 26.7), 84.2% (SD 7.5), 48.7 min (SD 27.3), and 435.8 min (69.2), respectively. PROMIS sleep disturbance was significantly correlated with abdominal pain (r=0.56), bloating (r=0.43), constipation (r=0.46), fatigue (r=0.50), and stress (r=0.42). PROMIS sleep-related impairment was significantly correlated with bloating (r=0.47), constipation (r=0.50), fatigue (r=0.60), depression (r=0.42), and stress (r=0.46). Onset latency was significantly correlated with anxiety (r=0.41) and stress (r=0.42). Sleep time was significantly correlated with fatigue (r=0.42). CONCLUSION This study highlights sleep disturbances are prevalent in those with IBD and significantly correlated with both GI and extraintestinal symptoms. Future work is needed to explore these relationships further and the potential benefit of sleep interventions in this population.

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.

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.

Sex-based differences in remote monitoring of biometric, psychometric and biomarker indices in stable ischemic heart disease

BackgroundSex-based differences are crucial to consider in the formulation of a personalized treatment plan. We evaluated sex-based differences in adherence and remotely monitored biometric, psychometric, and biomarker data among patients with stable ischemic heart disease (IHD).MethodsThe Prediction, Risk, and Evaluation of Major Adverse Cardiac Events (PRE–MACE) study evaluated patients with stable IHD over a 12-week period. We collected biometric and sleep data using remote patient monitoring via FitBit and psychometric data from Patient-Reported Outcomes Measurement Information System (PROMIS), Kansas City Cardiomyopathy (KCC) and Seattle Angina Questionnaire-7 (SAQ-7) questionnaires. Serum biomarker levels were collected at the baseline visit. We explored sex-based differences in demographics, adherence to study protocols, biometric data, sleep, psychometric data, and biomarker levels.ResultsThere were 198 patients enrolled, with mean age 65.5 ± 11 years (± Standard deviation, SD), and 60% were females. Females were less adherent to weekly collection of PROMIS, KCC and SAQ-7 physical limitations questionnaires (all p < 0.05), compared to males. There was no difference in biometric physical activity. There was a statistically significant (p < 0.05) difference in sleep duration between sexes, with females sleeping 6 min longer. However, females reported higher PROMIS sleep disturbance scores (p < 0.001) and poorer psychometric scores overall (p < 0.05). A higher proportion of males had clinically significant elevations of median N-terminal pro-brain natriuretic peptide (p = 0.005) and high-sensitivity cardiac troponin levels (p < 0.001) compared to females.ConclusionsAmong females and males with stable IHD, there are sex-based differences in remote monitoring behavior and data. Females are less adherent to psychometric data collection and report poorer psychometric and sleep quality scores than males. Elevated levels of biomarkers for MACE are more common in males. These findings may improve sex-specific understanding of IHD using remote patient monitoring.

Longitudinal course and phenotypes of health-related quality of life in adults with atopic dermatitis.

The real-world course of health-related quality of life (HRQoL) in atopic dermatitis (AD) is not well established. To examine predictors, longitudinal course and phenotypes of HRQoL in adult patients with AD. This was a prospective dermatology-practice based study of 955 patients with AD (age 18-97 years). Patients were assessed at baseline and approximately 6, 12, 18 and 24 months. HRQoL was assessed using the 10-item short-form Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health (PGH). AD severity and impact was assessed by patient-reported global AD severity, Patient-Oriented Eczema Measure (POEM), Eczema Area and Severity Index (EASI), Objective SCORing Atopic Dermatitis (O-SCORAD), Investigator's Global Assessment (IGA), Numerical Rating Scale (NRS) average and worst itch, PROMIS sleep-related impairment (SRI), and nine-item Patient Health Questionnaire (PHQ)-9. Repeated-measures regression models were constructed to examine itch over time. In multivariable linear regression models controlling for age, race/ethnicity, history of asthma, hay fever and food allergy, baseline PGH-physical (PGH-P4) T scores were inversely associated with patient-reported global AD severity, POEM, EASI, objective SCORAD, IGA, NRS average and worst itch, PROMIS SRI and PHQ-9, with stepwise decreases of physical health with worsening severity. PGH-mental health (PGH-M4) T scores were associated with all aforementioned severity measures aside from POEM. In multivariable repeated measures linear regression models, decreased PGH-P4 and PGH-M4 T scores and mapped five-dimension EuroQoL over time were associated with self-reported global AD severity, NRS worst and mean itch, POEM, PROMIS sleep disturbance and SRI, EASI, objective SCORAD, IGA and PHQ-9. Latent class analysis identified six classes of HRQoL, which were associated with measures of AD severity, nonwhite race, Hispanic ethnicity and having only public health insurance, but not age or sex. Patients with AD have a heterogeneous longitudinal course and distinct patterns of HRQoL. Many patients had fluctuating HRQoL over time. Most patients with moderate to severe disease at baseline had persistent HRQoL impairment over time.

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.

Measurement Properties of 4 Patient-Reported Outcome Measures to Assess Sleep Disturbance in Adults With Atopic Dermatitis.

The ideal patient-reported outcome measure to assess sleep disturbance in atopic dermatitis (AD) has not been determined. We sought to determine the measurement properties of the Patient-Reported Outcomes Measurement Information System (PROMIS) Itch Questionnaire Mood and Sleep (PIQ-MS), Sleep Disturbance (SD), Sleep-Related Impairment (SRI), and Epworth Sleepiness Scale (ESS) in adults with AD. A prospective dermatology practice-based study was performed using questionnaires and evaluation by a dermatologist (n=611). PIQ-MS, PROMIS SD, SRI, and ESS had good convergent validity with intensity and frequency of sleep disturbance, Patient-Oriented Eczema Measure, Eczema Area and Severity Index, total and objective-Scoring AD, Numerical Rating Scale of worst-itch and average-itch, and Dermatology Life Quality Index. PIQ-MS had significantly better correlations with other severity measures than the other sleep measures (Fisher z-scores, P≤0.007). PIQ-MS, and to lesser extent PROMIS SD, PROMIS SRI and ESS had good discriminant validity. All four sleep assessments showed fair responsiveness to change of severity of sleep-disturbance, AD and itch. PIQ-MS had the best reliability. PIQ-MS, PROMIS SD, SRI and ESS showed good internal consistency and were feasible for use in clinical practice. PIQ-MS, followed by PROMIS SD, had the best construct validity and reliability in adult AD.

549 Measurement properties of four different patient-reported outcomes to assess sleep disturbance in adults with atopic dermatitis

Sleep is commonly impacted in atopic dermatitis (AD). However, the ideal patient-reported outcome measures to assess sleep in AD patients has not been determined. We sought to determine the measurement properties of the Patient-Reported Outcomes Measurement Information System (PROMIS) Itch Questionnaire (PIQ)-Mood and Sleep, Sleep Disturbance (SD), Sleep-Related Impairment (SRI), and Epworth Sleepiness Scale (ESS) in adults with AD. We performed a prospective dermatology practice-based study using questionnaires and evaluation by a dermatologist (n=491). PIQ Mood and Sleep, PROMIS SD, SRI, and ESS had good convergent validity with intensity and frequency of sleep disturbance, Patient-Oriented Eczema Measure, Eczema Area and Severity Index, total and objective-Scoring AD, Numerical Rating Scale of worst-itch and average-itch, and Dermatology Life Quality Index. PIQ Mood and Sleep had significantly better correlations with other severity measures than the other sleep measures (Fisher z-scores, P≤0.04 for all). PIQ Mood and Sleep had fair ability to distinguish between levels of severity of sleep disturbance, AD or itch, i.e. criterion validity. PROMIS SD, PROMIS SRI and ESS had poor to fair ability to distinguish between different levels of sleep, AD and/or itch severity. All four sleep assessments showed fair responsiveness to change of severity of sleep-disturbance, AD and itch, had good internal consistency, with no floor or ceiling effects, and were feasible for use in clinical practice. In conclusion, PIQ Mood and Sleep, PROMIS SD, PROMIS SRI and ESS showed good construct validity, internal consistency and responsiveness in adult AD. PIQ Mood and Sleep, followed by PROMIS SD, had the best measurement properties in adult AD.

0489 Initial Results from the Hypertension with Unsatisfactory Sleep Health (HUSH) Clinical Trial for Primary Care Patients with Insomnia and Comorbid Hypertension (INS-HTN)

Abstract Introduction Insomnia is commonly comorbid with, and may contribute to, hypertension. Cognitive-behavioral treatments improve insomnia, but their effects on hypertension are uncertain, and they are often unavailable in primary care practices, where most INS-HTN patients are treated. We evaluated the efficacy of Brief Behavioral Treatment for Insomnia (BBTI) and Sleep Healthy Using the Internet (SHUTi) compared to enhanced usual care (EUC) on insomnia and home blood pressure (HBP) in primary care patients with INS-HTN. Methods Patients were recruited via electronic health records from 67 primary care practices and randomized 2:2:1 to BBTI delivered via telephone/videoconferencing; SHUTi, an automated, web-based CBT-I program; or EUC including a patient education video. Assessments included self-report questionnaires, home sleep apnea testing, and one week of sleep diary and HBP, measured at Baseline and 9 weeks/ 6 months post-treatment. The primary outcome was the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance scale. Linear mixed models were fitted for continuous variables on the intent-to-treat sample (n=548), adjusting for age and sex. Chi-square tests were used for proportions. Results Patients were 61.8±11.3 years old, 67.2% female, and 55.9% were taking hypnotics. Insomnia Severity Index (ISI) was 15.4±4.4, Apnea-Hypopnea Index 9.8±11.4, and HBP 130±14/81±9. BBTI and SHUTi were significantly better than EUC (p≤.002) at 9 weeks and 6 months on PROMIS Sleep Disturbance and Sleep-Related Impairment scales, ISI, and diary sleep efficiency, but had inconsistent effects on PROMIS depression and anxiety scales (p=0.001-0.9). Greater proportions of BBTI and SHUTi vs. EUC-treated patients had 9-week and 6-month ISI scores &amp;lt;8 (p=.01, p=.04) and ISI changes scores ≥7 (p=.002, p=.003). HBP did not significantly differ by intervention group. Conclusion BBTI and SHUTi improved insomnia, but did not reduce HBP in patients with INS-HTN. These interventions appear suitable for dissemination and implementation in primary care, but may have limited effects on comorbid symptoms and conditions. Support NHLBI UH2/UH3 HL125103

Assessing Rheumatoid Arthritis Disease Activity With Patient-Reported Outcomes Measurement Information System Measures Using Digital Technology.

Health information technology has enabled efficient measurement of patient-reported outcomes (PROs). The National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) is becoming more widely adopted for research and routine care, and some PROMIS instruments might be substituted for lengthier, legacy PRO instruments. Four PROMIS computer-adaptive testing (CAT) instruments (pain interference, physical function, sleep disturbance, and fatigue) and the Routine Assessment of Patient Index Data 3 (RAPID3), along with pain intensity and patient global assessment score, were administered to participants in the ArthritisPower registry. The RAPID3 was predicted using different combinations of these variables to create a new score (CAT-PROMIS RAPID3). Kappa statistics and Bland-Altman 95% limits of agreement were used to measure agreement between the observed versus predicted RAPID3. A total of 6,154 eligible patients contributed 11,275 observations. The mean ± SD age was 52.7 ± 10.5years, and 93% of patients were women. The median assessment times ranged from 29 seconds (PROMIS sleep disturbance) to 116 seconds (RAPID3). As single pairwise comparisons, the PROMIS CATs examined were modestly correlated (r approximately 0.4-0.7) to one other and RAPID3. Together with the pain intensity and patient global assessment, the PROMIS instruments explained a high fraction of total variance (R2 = 0.97) of the RAPID3 score. In the model with the highest agreement (κ = 0.93) between the observed RAPID3 and the CAT-PROMIS predicted RAPID3, Bland-Altman 95% limits of agreement showed minimal residual differences and no systematic biases. There was excellent agreement between the observed RAPID3 and predicted RAPID3 scores estimated using several PROMIS instruments. The Multidimensional Health Assessment Questionnaire and patient global assessment components of RAPID3 may be unnecessary if PROMIS scores are available.

Comparison of Patient-Oriented Eczema Measure and Patient-Oriented Scoring Atopic Dermatitis vs Eczema Area and Severity Index and other measures of atopic dermatitis: A validation study

BackgroundLittle is known about the measurement properties of Patient-Oriented Scoring Atopic Dermatitis (PO-SCORAD) in adults with atopic dermatitis (AD). Even less is known about how PO-SCORAD performs compared with the Patient-Oriented Eczema Measure (POEM). ObjectiveTo examine the measurement properties of PO-SCORAD and compare them with those of POEM. MethodsA prospective dermatology practice–based study of 291 patients with AD (age range, 18-72 years). ResultsPO-SCORAD and POEM were moderately correlated with each other (Spearman ρ = 0.56) and had weak-moderate correlations with the Numeric Rating Scale (NRS) worst itch and average itch, Dermatology Life Quality Index (DLQI), ItchyQOL, Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SD) and Sleep-Related Impairment (SRI), Patient Health Questionnaire-9 (PHQ-9), and Eczema Area and Severity Index (EASI) (P < .001). POEM had significantly stronger correlations with DLQI, ItchyQOL, and EASI than did PO-SCORAD. PO-SCORAD and POEM had fair discriminant validity. Changes from baseline in PO-SCORAD and POEM were moderately correlated with each other; were weakly to strongly correlated with NRS worst itch and average itch, DLQI, ItchyQOL, PROMIS SD, PROMIS SRI, PHQ-9, and EASI; and had good test-retest reliability. There was no differential item functioning of items or floor or ceiling effects for PO-SCORAD or POEM. The thresholds for meaningful change for PO-SCORAD and POEM were −15.5 and −5.0, respectively. Median completion times for PO-SCORAD and POEM were 3 minutes and 1 minute, respectively. ConclusionPO-SCORAD and POEM had good construct and cross-cultural validity, reliability, and responsiveness in adults with AD and were feasible for use in clinical trials and practice. However, POEM had better measurement properties than PO-SCORAD.

Validation of Patient-Reported Outcomes Information System Sleep Disturbance and Sleep-Related Impairment in adults with atopic dermatitis.

Sleep disturbances are common in adults with atopic dermatitis (AD). Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SD) and Sleep-Related Impairment (SRI) are validated questionnaires to assess sleep in adults. Little is known about their measurement properties in adults with AD. To assess the measurement properties of the PROMIS SD and SRI eight-item short forms in AD. We performed a prospective dermatology-practice-based study using questionnaires and evaluation by a dermatologist (n = 420). PROMIS SD and SRI showed moderate correlations to each other (ρ = 0·67), and weak correlations with Patient-Oriented Eczema Measure (ρ = 0·43 and 0·39, respectively); average (ρ = 0·31/0·30) and worst numerical rating scale for itch (ρ = 0·32/0·30); Eczema Area and Severity Index (ρ = 0·41/0·31); and Scoring Atopic Dermatitis (SCORAD) (ρ = 0·44/0·30) (Spearman correlations, P < 0·001). PROMIS SD and SRI increased significantly and stepwise with more frequent sleep disturbance, severe itch and self-reported global AD severity (ancova,P < 0·001). PROMIS SD and SRI showed good internal consistency (Cronbach alpha 0·84 and 0·91). Changes from baseline in PROMIS SD and SRI were weakly to moderately correlated with each other and with changes of multiple patient-reported and clinician-reported AD outcomes. There were no floor or ceiling effects for PROMIS SD or SRI. The median completion time for PROMIS SD and SRI was 2 min. PROMIS SD and SRI showed good construct validity, internal consistency, responsiveness and feasibility to assess sleep in adult patients with AD. What is already known about this topic? The Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SD) and Sleep-Related Impairment (SRI) scales were found to be valid in adults with chronic disease. However, the validity and feasibility of PROMIS SD and SRI in atopic dermatitis remain unknown. What does this study add? This study demonstrated that PROMIS SD and SRI had good content, concurrent, convergent and discriminant validity; feasibility; and responsiveness, with no floor or ceiling effects observed. What are the clinical implications of this work? The PROMIS SD and SRI eight-item bank short forms appear to have sufficient validity and feasibility to be used as assessments for burden of sleep in adults with atopic dermatitis in clinical practice.

Abstract P313: Self-reported Sleep Disturbance is Associated With Poor Hypertension Self-management in Latinos

Background: Antihypertensive medication adherence is an important determinant of hypertension control. Although Latinos have high rates of uncontrolled hypertension, factors associated with anti-hypertensive medication adherence in this population are poorly understood. Self-reported sleep disturbance is associated with impaired chronic disease self-management in the general population. To date, no study has examined the association of sleep disturbance with hypertension self-management among Latinos. Hypothesis: Sleep disturbances will be associated with poor anti-hypertensive medication adherence and higher rates of uncontrolled hypertension in Latinos. Methods: We used cross-sectional data from the Washington Heights/Inwood Comparative Effectiveness Research (WICER) Project to assess the link between sleep disturbance with anti-hypertensive medication adherence and uncontrolled hypertension among Latinos with hypertension. The 8-item Morisky Medication Adherence Scale (MMAS) was used to assess medication adherence (alpha 0.75; range 0-8). The 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance measure was used (alpha 0.75; range 4-20). Uncontrolled hypertension was defined as a systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥80 mm Hg. Multiple logistic regression models were used to examine the associations of self-reported sleep disturbance with low medication adherence (MMAS &lt;6). In addition, we examined whether sleep disturbance was associated with uncontrolled hypertension. Models were adjusted for age, sex, education, preferred language, insurance status, comorbid conditions, and anxiety. Results: The final sample consisted of 1,116 Latino participants with hypertension (mean age 63.2, 76.8% were female, and 69.5% had completed less than a high school education). The mean MMAS and PROMIS sleep disturbance scores were 1.9 and 10.1, respectively. A total of 341 (30.4%) participants were classified as having low medication adherence. Participants with low medication adherence were more likely to be younger (p &lt;0.001), single (p &lt;0.001), and have lower educational attainment (p &lt;0.01). After covariate adjustment, a one-point increase in sleep disturbance was associated with higher odds of low medication adherence (AOR 1.05, 95% CI [1.01-1.09]). Sleep disturbance was also associated with higher odds of uncontrolled hypertension (AOR 1.04, 95% CI [1.01-1.07]). Conclusions: Reducing sleep disturbance in Latinos may be an important target for improving hypertension self-management. It remains unclear whether sleep disturbances are a cause of poor hypertension self-management in these patients. Additional research that incorporates longitudinal designs is needed to examine associations between sleep disturbance and hypertension self-management among Latinos.

Worry and Rumination Have Distinct Associations with Nighttime versus Daytime Sleep Symptomology

ABSTRACT Objective: To assess whether worry and rumination differ in predicting nighttime sleep disturbance versus daytime sleep-related impairment, as assessed using short forms from the Patient Reported Outcomes Measurement Information System (PROMIS). Participants: Adults recruited from the United States population (N = 459) via an online crowdsourcing service. Methods: Factor analysis explored whether items comprising validated measures of worry and rumination loaded onto separate factors. Hierarchical multiple regression models entered worry and rumination in a stepwise fashion to assess their relative strength in predicting PROMIS sleep disturbance and sleep-related impairment, after controlling for 17 covariates. All analyses were run twice using sleep-specific and general measures of worry and rumination. Results: Worry and rumination items loaded onto separate factors. In the regression analysis of sleep-specific cognition, only worry entered the model predicting sleep disturbance, whereas rumination entered after worry in the model predicting sleep-related impairment. In the analysis of general cognition, both cognitive process variables significantly predicted the PROMIS outcomes. Worry was the stronger predictor of sleep disturbance, whereas rumination was the stronger predictor of sleep-related impairment. Conclusions: Worry and rumination were observed to be distinct constructs that separately contributed to predicting daytime sleep-related impairment. Future studies should more closely examine how cognitive processes relate to insomnia symptomology during the day.

Caregiver Patient Reported Outcomes Measurement Information System (PROMIS) profiles in patients undergoing total joint arthroplasty and spine surgery: a prospective observational cohort study

Background/ObjectiveThe role of caregiver psychosocial characteristics and their relation to postsurgical caregiving capability remains unclear. The objective of this study was to explore caregiver psychosocial variables following surgery of patients...

An Onsite Fitness Facility and Integrative Wellness Program Positively Impacted Health-Related Outcomes Among Teachers and Staff at an Urban Elementary/Middle School.

BackgroundGiven the large number of obesity-focused studies conducted in schools, there is a surprising lack of data regarding teacher workplace health behaviors in the United States.ObjectiveTo determine the feasibility and effectiveness of an onsite fitness facility with a structured integrative wellness program to improve health-related outcomes among teachers and staff at an urban elementary/middle school.MethodsA 2-year mixed-methods analysis using Patient-Reported Outcomes Measurement Information System (PROMIS) measures and qualitative interviews included 39 teachers and staff employed at an urban elementary/middle school in Baltimore, Maryland. The fitness facility was dedicated exclusively to teachers and staff and the integrative wellness program included group exercise classes, yoga, mindfulness, and nutrition competitions. T tests were used to compare quantitative outcomes at baseline, the end of year 1, and the end of year 2.ResultsCompared to baseline, at year 1, there was a significant improvement in the PROMIS Sleep Disturbance score. From baseline to end of year 2, there were significant increases in the PROMIS Global Physical Health as well as significant decreases in Sleep Disturbances, Fatigue, and Social Isolation. Qualitative interviews conducted at the end of year 1 indicated that teachers who used the facility felt that it improved their mood, increased their energy, motivated them to eat healthily, and gave them opportunities to socialize with their colleagues in new ways. This impact was further enhanced in year 2.ConclusionsAn onsite fitness facility with an integrative wellness program may improve health-related outcomes among urban elementary school teachers and staff, with the greatest benefits seen after 2 years of implementation.