EP30 Understanding which patient-reported outcomes are important to rheumatology patients: findings from ArthritisPower

Abstract Background Little is known about PRO measures patients find most important for disease, treatment effectiveness/health outcomes. In this study, we examined PROs selected by patients with rheumatologic conditions to further elucidate which disease symptoms they found most important to track within ArthritisPower registry. As the study is ongoing, we discuss initial PRO selections of study participants. Methods Adult US patients with self-reported rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), systemic lupus erythematosus (SLE), osteoporosis (OP), osteoarthritis (OA), fibromyalgia syndrome (FMS) in ArthritisPower were invited to participate and prompted to select up to ten PRO (symptom) measures they felt were important to track their condition at baseline via ArthritisPower smartphone and Web-based app. PROs Measurement Information System (PROMIS) instruments focusing on symptoms of pain, physical and cognitive function, mental health, fatigue, social function, work impact, sexual function, and sleep, and Outcomes Measures in Rheumatology (OMERACT) RA flare instrument (only for those with RA) and Lilly-developed morning joint-stiffness duration question were offered. At Month (m)1, m2, m3, participants were given the option to continue tracking their selected PRO measures or change. At m3, participants complete an exit survey prioritizing all measures selected during participation and specifying other symptoms not available they would have wanted to track. Descriptive statistics were conducted on baseline data. Results As of May 2019, 292 participants enrolled (251 completed baseline assessments). Mean age was 55.6 (9.2) years, 89.6% female, 91.2% White, mean disease duration of 12 (10.7) years; similar to the overall ArthritisPower population. Majority (64.1%) self-reported OA, followed by RA (49.0%), FMS (40.6%), PsA (26.3%), OP (20.3%), AS (15.5%), SLE (5.6%), not mutually exclusive. Top 3 PRO domains chosen at baseline were fatigue, mental health, pain (Table 1). Average number of instruments selected for baseline completion was 6.9 (2.4). Conclusion Participants prioritised tracking fatigue, aspects of mental health, pain, physical function, social function, sleep, morning stiffness. These findings provide insights into symptoms rheumatology patients find most important; useful to inform the design of future patient-centric clinical trials and real-world evidence generation. Disclosures T. Daud (Non-Author Presenter) None. W.B. Nowell: Shareholder/stock ownership; WN has Ownership Interest (stocks, stock options, or other ownership interest excluding diversified mutual funds). C.L. Kannowski Corporate appointments; CLK is an employee of Eli Lilly and Company. Shareholder/stock ownership; CLK owns stock options at Eli Lilly and Company. K. Gavigan: None. Z. Cai: Corporate appointments; ZC is an employee of Eli Lilly and Company. Shareholder/stock ownership; shareholder of Eli Lilly and Company. A. Cardoso: Corporate appointments; AC is an employee of Eli Lilly and Company. Shareholder/stock ownership; AC is a stockholder of Eli Lilly and Company. T. Hunter: Corporate appointments; TH is an employee of Eli Lilly and Company. Shareholder/stock ownership; TH is a shareholder of Eli Lilly and Company. J. Birt: Corporate appointments; JB is an employee of Eli Lilly and Company. Shareholder/stock ownership; JB is a shareholder of Eli Lilly and Company. J. Workman: Corporate appointments; JW is an employee of Eli Lilly and Company. J. Curtis: Consultancies; JC has received Consulting Fees from AbbVie, Amgen, BMS, Corrona, Eli Lilly, Janssen, Myriad, Pfizer, Regeneron, Roche, UCB. Grants/research support; JC has received grants/research support from AbbVie, Amgen, BMS, Corrona, Eli Lilly, Janssen, Myriad, Pfizer, Regeneron, Roche, UCB.

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Which patient-reported outcomes do rheumatology patients find important to track digitally? A real-world longitudinal study in ArthritisPower

Arthritis Research & Therapy ◽

10.1186/s13075-021-02430-0 ◽

2021 ◽

Vol 23 (1) ◽

Author(s):

W. Benjamin Nowell ◽

Kelly Gavigan ◽

Carol L. Kannowski ◽

Zhihong Cai ◽

Theresa Hunter ◽

...

Keyword(s):

Physical Function ◽

Lupus Erythematosus ◽

Patient Reported Outcomes ◽

Treatment Effectiveness ◽

Time Window ◽

Joint Stiffness ◽

Summary Score ◽

Longitudinal Tracking ◽

Patient Reported

Abstract Background Patient-reported outcomes (PROs) are increasingly used to track symptoms and to assess disease activity, quality of life, and treatment effectiveness. It is therefore important to understand which PROs patients with rheumatic and musculoskeletal disease consider most important to track for disease management. Methods Adult US patients within the ArthritisPower registry with ankylosing spondylitis, fibromyalgia syndrome, osteoarthritis, osteoporosis, psoriatic arthritis, rheumatoid arthritis, and systemic lupus erythematosus were invited to select between 3 and 10 PRO symptom measures they felt were important to digitally track for their condition via the ArthritisPower app. Over the next 3 months, participants (pts) were given the option to continue tracking their previously selected measures or to remove/add measures at 3 subsequent monthly time points (month [m] 1, m2, m3). At m3, pts prioritized up to 5 measures. Measures were rank-ordered, summed, and weighted based on pts rating to produce a summary score for each PRO measure. Results Among pts who completed initial selection of PRO assessments at baseline (N = 253), 140 pts confirmed or changed PRO selections across m1–3 within the specified monthly time window (28 days ± 7). PROs ranked as most important for tracking were PROMIS Fatigue, Physical Function, Pain Intensity, Pain Interference, Duration of Morning Joint Stiffness, and Sleep Disturbance. Patient’s preferences regarding the importance of these PROs were stable over time. Conclusion The symptoms that rheumatology patients prioritized for longitudinal tracking using a smartphone app were fatigue, physical function, pain, and morning joint stiffness.

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Feasibility, Validity, and Reliability of the 10-item Patient Reported Outcomes Measurement Information System Global Health Short Form in Outpatients with Systemic Lupus Erythematosus

The Journal of Rheumatology ◽

10.3899/jrheum.170590 ◽

2018 ◽

Vol 45 (3) ◽

pp. 397-404 ◽

Cited By ~ 8

Author(s):

Shanthini Kasturi ◽

Jackie Szymonifka ◽

Jayme C. Burket ◽

Jessica R. Berman ◽

Kyriakos A. Kirou ◽

...

Keyword(s):

Mental Health ◽

Lupus Erythematosus ◽

Patient Reported Outcomes ◽

Short Form ◽

Measurement Information ◽

Physical And Mental Health ◽

Validity And Reliability ◽

Sf 36 ◽

Patient Reported ◽

Health Domains

Objective.To assess the feasibility, validity, and reliability of the Patient Reported Outcomes Measurement Information System Global Health Short Form (PROMIS10) in outpatients with systemic lupus erythematosus (SLE).Methods.SLE outpatients completed PROMIS10, Medical Outcomes Study Short Form-36 (SF-36), LupusQoL-US, and selected PROMIS computerized adaptive tests (CAT) at routine visits at an SLE Center of Excellence. Construct validity was evaluated by correlating PROMIS10 physical and mental health scores with PROMIS CAT, legacy instruments, and physician-derived measures of disease activity and damage. Test-retest reliability was determined among subjects reporting stable SLE activity at 2 assessments 1 week apart using intraclass correlation coefficients (ICC).Results.A diverse cohort of 204 out of 238 patients with SLE (86%) completed survey instruments. PROMIS10 physical health scores strongly correlated with physical function, pain, and social health domains in PROMIS CAT, SF-36, and LupusQoL, while mental health scores strongly correlated with PROMIS depression CAT, SF-36, and LupusQoL mental health domains (Spearman correlations ≥ 0.70). Active arthritis, comorbid fibromyalgia (FM), and anxiety were associated with worse PROMIS10 scores, but sociodemographic factors and physician-assessed flare status were not. Test-retest reliability for PROMIS10 physical and mental health scores was high (ICC ≥ 0.85). PROMIS10 required < 2 minutes to complete.Conclusion.PROMIS10 is valid and reliable, and can efficiently screen for impaired physical function, pain, and emotional distress in outpatients with SLE. With strong correlations to LupusQoL and SF-36 but significantly reduced responder burden, PROMIS10 is a promising tool for measuring patient-reported outcomes in routine SLE clinical care and value-based healthcare initiatives.

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3047 Patient-Reported Outcomes Measurement Information System (PROMIS®) Global Health Short Form is Responsive to Patient Reported Changes in Systemic Lupus Erythematosus

Journal of Clinical and Translational Science ◽

10.1017/cts.2019.344 ◽

2019 ◽

Vol 3 (s1) ◽

pp. 151-151

Author(s):

Shanthini Kasturi ◽

Jackie Szymonifka ◽

Jessica Berman ◽

Kyriakos Kirou ◽

Alana Levine ◽

...

Keyword(s):

Mental Health ◽

Lupus Erythematosus ◽

Global Assessment ◽

Short Form ◽

Global Mental Health ◽

Effect Sizes ◽

Measurement Information ◽

Physician Global Assessment ◽

Patient Reported

OBJECTIVES/SPECIFIC AIMS: The accurate and efficient serial measurement of patient centered outcomes is a priority in the clinical care of systemic lupus erythematosus (SLE). Patient-Reported Outcomes Measurement Information Systems (PROMIS®) Global Health Short Form (PROMIS10) is a 10-item universal patient reported outcome measure of global physical and mental health with construct validity in SLE. The longitudinal responsiveness (sensitivity to change) of PROMIS10 in SLE patients is unknown. We aimed to evaluate the responsiveness of PROMIS10 in SLE outpatients using patient and physician-derived anchors. METHODS/STUDY POPULATION: Adults meeting SLE classification criteria were recruited from an SLE Center of Excellence. Subjects completed PROMIS10 at two visits a minimum of one month apart. SLE disease activity was measured with a patient global assessment of change, a physician global assessment and the physician-derived SELENA-SLEDAI. Responsiveness over time of PROMIS10 scores was evaluated using known-groups validity. Effect sizes of changes in PROMIS global physical health and global mental health scores from baseline to follow up were compared across groups of patients who differed in their patient global assessment of change, physician global assessment, and SELENA-SLEDAI using Kruskal-Wallis tests. RESULTS/ANTICIPATED RESULTS: A diverse cohort of 228 SLE patients completed baseline surveys (Table 1), with 190 (83%) completing a follow up survey. Using the patient-based anchor, PROMIS10 demonstrated mild to moderate responsiveness to improvement (effect size 0.29) and worsening (effect sizes −0.27 and −0.54) of health status for both global physical health and global mental health (Table 2). Using the physician global assessment and SELENA-SLEDAI as anchors, there were no statistically significant differences in effect sizes across groups. DISCUSSION/SIGNIFICANCE OF IMPACT: PROMIS10 showed responsiveness over time to patient-reported, but not physician-derived changes in lupus health status. These data suggest that PROMIS10 can be used to efficiently measure and monitor important aspects of the patient experience of lupus not captured by physician-derived metrics. Further studies are needed to evaluate the role of PROMIS in optimizing longitudinal disease management in SLE.

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Prevalence of anxiety and depressive symptoms and impact on self-management among adults with chronic conditions in Chicago, Illinois, USA, during the COVID-19 pandemic: a cross-sectional survey

BMJ Open ◽

10.1136/bmjopen-2021-052495 ◽

2022 ◽

Vol 12 (1) ◽

pp. e052495

Author(s):

Rebecca M Lovett ◽

Lauren Opsasnick ◽

Andrea Russell ◽

Esther Yoon ◽

Sophia Weiner-Light ◽

...

Keyword(s):

Mental Health ◽

Depressive Symptoms ◽

Chronic Conditions ◽

Least Square ◽

Self Management ◽

Secondary Outcome ◽

Measurement Information ◽

Cross Sectional Survey ◽

Cross Sectional ◽

Patient Reported

ObjectivesTo examine the prevalence of mental health symptoms during the first surge of COVID-19 in the USA, and their associations with COVID-19-related emotional distress, health self-management and healthcare utilisation.DesignCross-sectional analysis of wave 3 (1–22 May 2020) survey data from the ongoing Chicago COVID-19 Comorbidities (C3) study.SettingSeven academic and community health centres in Chicago, Illinois.Participants565 adults aged 23–88 with one or more chronic conditions completing at least one prior C3 study wave.Primary and secondary outcome measuresClinically relevant anxiety and depressive symptoms as measured using Patient-Reported Outcomes Measurement Information System short forms. Self-reported emotional and health-related responses to COVID-19 were measured through a combination of single-item questions and validated measures.ResultsRates of anxiety and depressive symptoms were 14% (81/563) and 15% (84/563), respectively. Anxiety and depressive symptoms were then each separately associated with greater worry about contracting COVID-19 (relative risk (RR) 2.32, 95% CI 1.52 to 3.53; RR 1.67, 95% CI 1.10 to 2.54), greater stress (RR 4.93, 95% CI 3.20 to 7.59; RR 3.01, 95% CI 1.96 to 4.61) and loneliness (RR 3.82, 95% CI 2.21 to 6.60; RR 5.37, 95% CI 3.21 to 8.98), greater avoidance of the doctor (RR 1.62, 95% CI 1.06 to 2.49; RR 1.54, 95% CI 1.00 to 2.36) and difficulty managing health (least square means (LS Means) 6.09, 95% CI 5.25 to 6.92 vs 4.23, 95% CI 3.70 to 4.75; LS Means 5.85, 95% CI 5.04 to 6.65 vs 4.22, 95% CI 3.70 to 4.75) and medications (LS Means 3.71, 95% CI 2.98 to 4.43 vs 2.47, 95% CI 2.02 to 2.92) due to the pandemic.ConclusionsIdentifying and addressing mental health concerns may be an important factor to consider in COVID-19 prevention and management among high-risk medical populations.

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Implementation of a Mental Health Screening Program in a Pediatric Tertiary Care Setting

Clinical Pediatrics ◽

10.1177/0009922819862613 ◽

2019 ◽

Vol 58 (10) ◽

pp. 1078-1084

Author(s):

Linda Herbert ◽

Steven Hardy

Keyword(s):

Mental Health ◽

Screening Program ◽

Tertiary Care ◽

Health Screening ◽

Mental Health Screening ◽

Measurement Information ◽

Pediatric Allergy ◽

Patient Reported ◽

Almost All ◽

Pediatric Subspecialty

We evaluated the acceptability and usefulness of brief mental health screening during pediatric subspecialty clinic visits. Patients (8-17 years) and parents (of patients 5-17 years) in pediatric allergy, immunology, and hematology clinics completed the PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Profile. Medical providers reviewed results and interpretations to guide discussion of mental health during visits. Almost all providers (96%) reported discussing mental health during visits but fewer parents (60%) said this discussion occurred. All parents who reported that mental health discussions occurred liked that this happened. Some parents (25%) who said no mental health discussion occurred wished it had. Most parents strongly agreed that screening completion was easy and appropriate. Most providers (79%) believed the screening was useful and 87% reported using screening results to guide discussion. Brief electronic mental health screening in pediatric subspecialty clinics is feasible, useful in guiding discussion, and viewed favorably by providers and parents of children with chronic illnesses.

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Characteristics of Clients Seeking Yoga Therapy in a University-Based Student Clinic

International Journal of Yoga Therapy ◽

10.17761/2021-d-20-00003 ◽

2020 ◽

Author(s):

Steffany Moonaz ◽

Marlysa Sullivan ◽

Daryl Nault ◽

Irene Bright-Dumm ◽

Ryan Bradley

Keyword(s):

Mental Health ◽

Patient Reported Outcomes ◽

The United States ◽

Study Data ◽

Measurement Information ◽

Physical And Mental Health ◽

Yoga Therapy ◽

Highly Educated ◽

Clinical Encounters ◽

Patient Reported

Abstract Yoga therapy is an emerging profession with recent development of educational competencies, training program accreditation, and practitioner certification. In the United States, most yoga therapy training programs are studio-based and data on mentored clinical encounters are lacking. This study aimed to characterize the client population in a university-based mentored student clinic. As part of a larger feasibility study, data were collected at all clinic visits for 70 consenting clients. Data collected included demographic characteristics, reasons for pursuing care, use of other healthcare approaches, and the Patient-Reported Outcomes Measurement Information System (PROMIS) for physical and mental health. Participants were mostly middle-aged, White, and highly educated. Common reasons for pursuing care were pain and mental health. Most used multiple healthcare approaches. Average scores for most patient-reported outcomes fell within normal range at baseline. Future studies are needed to better characterize yoga therapy users and to expand access for populations in whom the modality is underutilized despite emerging evidence of relevance.

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