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

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.

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

2018 ◽  
Vol 45 (3) ◽  
pp. 397-404 ◽  
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.

scholarly journals The Association Between Increased Levels of Patient Engagement With an Internet Support Group and Improved Mental Health Outcomes at 6-Month Follow-Up: Post-Hoc Analyses From a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Emily M Geramita ◽  
Bea Herbeck Belnap ◽  
Kaleab Z Abebe ◽  
Scott D Rothenberger ◽  
Armando J Rotondi ◽  
...  
Keyword(s):  
Mental Health ◽  
Support Group ◽  
Patient Engagement ◽  
Short Form ◽  
Measurement Information ◽  
Depression And Anxiety ◽  
Patient Reported ◽  
Internet Support Group ◽  
Internet Support

BACKGROUND We recently reported that depressed and anxious primary care patients randomized to a moderated internet support group (ISG) plus computerized cognitive behavioral therapy (cCBT) did not experience improvements in depression and anxiety over cCBT alone at 6-month follow-up. OBJECTIVE The 1% rule posits that 1% of participants in online communities generate approximately 90% of new user-created content. The aims of this study were to apply the 1% rule to categorize patient engagement with the ISG and identify whether any patient subgroups benefitted from ISG use. METHODS We categorized the 302 patients randomized to the ISG as: superusers (3/302, 1.0%), top contributors (30/302, 9.9%), contributors (108/302, 35.8%), observers (87/302, 28.8%) and those who never logged in (74/302, 24.5%). We then applied linear mixed models to examine associations between engagement and 6-month changes in health-related quality of life (HRQoL; Short Form Health Survey Mental Health Component, SF-12 MCS) and depression and anxiety symptoms (Patient-Reported Outcomes Measurement Information System, PROMIS). RESULTS At baseline, participant mean age was 42.6 years, 81.1% (245/302) were female, and mean Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder scale (GAD-7), and SF-12 MCS scores were 13.4, 12.6, and 31.7, respectively. Of the 75.5% (228/302) who logged in, 61.8 % (141/228) created ≥1 post (median 1, interquartile range, IQR 0-5); superusers created 42.3 % (630/1488) of posts (median 246, IQR 78-306), top contributors created 34.6% (515/1488; median 11, IQR 10-18), and contributors created 23.1 % (343/1488; median 3, IQR 1-5). Compared to participants who never logged in, the combined superuser + top contributor subgroup (n=33) reported 6-month improvements in anxiety (PROMIS: –11.6 vs –7.8; P=.04) and HRQoL (SF-12 MCS: 16.1 vs 10.1; P=.01) but not in depression. No other subgroup reported significant symptom improvements. CONCLUSIONS Patient engagement with the ISG was more broadly distributed than predicted by the 1% rule. The 11% of participants with the highest engagement levels reported significant improvements in anxiety and HRQoL. CLINICALTRIAL ClinicalTrials.gov NCT01482806; https://clinicaltrials.gov/ct2/show/NCT01482806 (Archived by WebCite at http://www.webcitation.org/708Bjlge9).

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

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Tariq Daud ◽  
William B Nowell ◽  
Carol L Kannowski ◽  
Kelly Gavigan ◽  
Zhihong Cai ◽  
...  
Keyword(s):  
Mental Health ◽  
Lupus Erythematosus ◽  
Stock Options ◽  
Treatment Effectiveness ◽  
Joint Stiffness ◽  
Social Function ◽  
Stock Ownership ◽  
Measurement Information ◽  
Research Support ◽  
Patient Reported

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.

scholarly journals The PROMIS Global Health Questionnaire Correlates With the QuickDASH in Patients With Upper Extremity Illness

Hand ◽  
2017 ◽  
Vol 13 (1) ◽  
pp. 118-121 ◽  
Author(s):  
Nicky Stoop ◽  
Mariano E. Menendez ◽  
Jos J. Mellema ◽  
David Ring
Keyword(s):  
Mental Health ◽  
Global Health ◽  
Upper Extremity ◽  
Patient Reported Outcomes ◽  
Global Mental Health ◽  
Pearson Correlation ◽  
Measurement Information ◽  
Consistent Finding ◽  
Patient Reported ◽  
Mental Health Subscale

Background: The objective of this study is to evaluate the construct validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health instrument by establishing its correlation to the Quick-Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire in patients with upper extremity illness. Methods: A cohort of 112 patients completed a sociodemographic survey and the PROMIS Global Health and QuickDASH questionnaires. Pearson correlation coefficients were used to evaluate the association of the QuickDASH with the PROMIS Global Health items and subscales. Results: Six of the 10 PROMIS Global Health items were associated with the QuickDASH. The PROMIS Global Physical Health subscale showed moderate correlation with QuickDASH and the Mental Health subscale. There was no significant relationship between the PROMIS Global Mental Health subscale and QuickDASH. Conclusions: The consistent finding that general patient-reported outcomes correlate moderately with regional patient-reported outcomes suggests that a small number of relatively nonspecific patient-reported outcome measures might be used to assess a variety of illnesses. In our opinion, the blending of physical and mental health questions in the PROMIS Global Health makes this instrument less useful for research or patient care.

Obesity increases the incidence of new-onset lupus nephritis and organ damage during follow-up in patients with systemic lupus erythematosus

Lupus ◽  
2020 ◽  
Vol 29 (6) ◽  
pp. 578-586 ◽  
Author(s):  
Ji-Hyoun Kang ◽  
Haimuzi Xu ◽  
Sung-Eun Choi ◽  
Dong-Jin Park ◽  
Jung-Kil Lee ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Confidence Interval ◽  
Lupus Erythematosus ◽  
Odds Ratio ◽  
Global Assessment ◽  
Clinical Manifestations ◽  
Organ Damage ◽  
Physician Global Assessment ◽  
Systemic Lupus

Objective This study explored the effects of obesity on clinical manifestations, disease activity and organ damage in Korean patients with systemic lupus erythematosus (SLE). Methods We assessed 393 SLE patients annually for three consecutive years based on demographic information, clinical manifestations, laboratory findings and Physician Global Assessment, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2000 and Systemic Lupus International Collaborating Clinics (SLICC) damage index (SDI) scores. Patients were grouped by body mass index (BMI): normal weight, BMI <23 kg/m2; overweight, 23 kg/m2 ≤BMI <25 kg/m2; obese, BMI ≥25 kg/m2. The impact of obesity on clinical outcomes was assessed using univariate and multivariate analyses. Results Of the 393 patients, 59 (15.0%) were obese at enrollment. They had more comorbidities compared with non-obese patients, including diabetes, hypertension, hyperlipidemia and pulmonary hypertension. Nephritis at enrollment and newly developed nephritis during follow-up were more common ( p = 0.002 and p = 0.002, respectively) and Physician Global Assessment and SDI scores were higher in these patients for three consecutive years ( p = 0.017 and p = 0.039, respectively). Multivariate analysis revealed that obesity was significantly associated with development of nephritis during follow-up (odds ratio = 26.636; 95% confidence interval, 11.370–62.399; p < 0.001) and cumulative organ damage (odds ratio = 4.096; 95% confidence interval, 2.125–7.894, p < 0.001). Conclusions The incidences of newly developed nephritis and cumulative organ damage were higher in obese SLE patients than in non-obese SLE patients.

scholarly journals Utility of the Brief Illness Perception Questionnaire to Monitor Patient Beliefs in Systemic Vasculitis

2020 ◽  
Vol 47 (12) ◽  
pp. 1785-1792
Author(s):  
Mollie N. Schwartz ◽  
Casey A. Rimland ◽  
Kaitlin A. Quinn ◽  
Marcela A. Ferrada ◽  
K. Bates Gribbons ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Global Assessment ◽  
Illness Perceptions ◽  
Short Form ◽  
Illness Perception ◽  
Physician Global Assessment ◽  
Psychological Burden ◽  
Illness Perception Questionnaire ◽  
Patient Reported ◽  
Brief Illness Perception Questionnaire

ObjectiveTo assess the validity and clinical utility of the Brief Illness Perception Questionnaire (BIPQ) to measure illness perceptions in multiple forms of vasculitis.MethodsPatients with giant cell arteritis (GCA), Takayasu arteritis (TA), antineutrophil cytoplasmic antibody–associated vasculitis (AAV), and relapsing polychondritis (RP) were recruited into a prospective, observational cohort. Patients independently completed the BIPQ, Multidimensional Fatigue Inventory (MFI), Medical Outcomes Study 36-item Short Form survey (SF-36), and a patient global assessment (PtGA) at successive study visits. Physicians concurrently completed a physician global assessment (PGA) form. Illness perceptions, as assessed by the BIPQ, were compared to responses from the full-length Revised Illness Perception Questionnaire (IPQ-R) and to other clinical outcome measures.ResultsThere were 196 patients (GCA = 47, TA = 47, RP = 56, AAV = 46) evaluated over 454 visits. Illness perception scores in each domain were comparable between the BIPQ and IPQ-R (3.28 vs 3.47, P = 0.22). Illness perceptions differed by type of vasculitis, with the highest perceived psychological burden of disease in RP. The BIPQ was significantly associated with all other patient-reported outcome measures (rho = |0.50–0.70|, P < 0.0001), but did not correlate with PGA (rho = 0.13, P = 0.13). A change in the BIPQ composite score of ≥ 7 over successive visits was associated with concomitant change in the PtGA. Change in the MFI and BIPQ scores significantly correlated over time (rho = 0.38, P = 0.0008).ConclusionThe BIPQ is an accurate and valid assessment tool to measure and monitor illness perceptions in patients with vasculitis. Use of the BIPQ as an outcome measure in clinical trials may provide complementary information to physician-based assessments.

scholarly journals Mental Health Has No Predictive Association With Self-Assessed Knee Outcome Scores in Patients After Osteochondral Allograft Transplantation of the Knee

2018 ◽  
Vol 6 (12) ◽  
pp. 232596711881236 ◽  
Author(s):  
Jakob Ackermann ◽  
Takahiro Ogura ◽  
Robert A. Duerr ◽  
Alexandre Barbieri Mestriner ◽  
Andreas H. Gomoll
Keyword(s):  
Mental Health ◽  
Linear Regression ◽  
Functional Outcomes ◽  
Regression Models ◽  
Short Form ◽  
Osteochondral Allograft ◽  
Linear Regression Models ◽  
Bivariate Correlation ◽  
Patient Reported

Background: Patient-reported outcome (PRO) measures are progressively utilized as evaluation tools in preoperative and postoperative assessments in orthopaedic practice. Identifying the potential utility of psychosocial factors to predict patient-reported pain and functional outcomes is of increasing interest to determine which patients will derive the greatest benefit from surgical treatment. Purpose/Hypothesis: The purpose of this study was to determine potential predictive associations between the preoperative 12-Item Short Form Health Survey Mental Component Summary (SF-12 MCS) score, patient characteristics or osteochondral allograft (OCA) morphology, and PROs in patients who underwent OCA transplantation. We hypothesized that poor preoperative mental health is associated with diminished PROs at final follow-up. Study Design: Case-control study; Level of evidence, 3. Methods: A total of 67 patients with a mean follow-up of 2.7 ± 1.0 years (range, 2-6 years) with complete preoperative and at least 24-month postoperative SF-12 MCS, Knee injury and Osteoarthritis Outcome Score (KOOS), Tegner, Lysholm, and International Knee Documentation Committee (IKDC) scores were included in this study. Pearson correlation coefficients and linear regression models were used to distinguish associations between age, sex, smoking status, body mass index, workers’ compensation, previous surgery, concomitant surgery, number of grafts, defect location, total graft size, SF-12 MCS score, and postoperative PRO scores as well as their improvement from baseline (delta). Results: The SF-12 MCS showed significant correlation with the KOOS Activities of Daily Living subscale ( P = .015), KOOS Sport/Recreation subscale ( P = .024), and IKDC ( P = .039). In the multivariable linear regression models, the SF-12 MCS had no predictive association with any PRO measure. Patient sex contributed significantly to the final regression models of the KOOS Sport/Recreation ( P = .042), Tegner score ( P = .024), and Lysholm score ( P = .031). The SF-12 MCS showed no bivariate correlation with changes in any PRO score (delta) ( P > .05). Conclusion: Preoperative mental health status did not predict perceived functional outcomes as assessed by PRO measures at final follow-up. Female sex was negatively correlated with KOOS Sport/Recreation, Tegner, and Lysholm scores.

scholarly journals Stress, Self-Efficacy, Worries, and Challenges for Caregivers of Children with Type 1 Diabetes During the COVID-19 Pandemic

2020 ◽  
Vol 3 ◽  
Author(s):  
Breanne Hand ◽  
Priya Soni ◽  
Rebecca Oyetoro ◽  
Anastasia Albanese-O’Neill ◽  
Heba Ismail ◽  
...  
Keyword(s):  
Mental Health ◽  
Type 1 Diabetes ◽  
Self Efficacy ◽  
Diabetes Management ◽  
Short Form ◽  
Severe Disease ◽  
Measurement Information ◽  
Increased Risk ◽  
Patient Reported

Background:  Approximately 200,000 American youth live with Type 1 Diabetes (T1D). Intensive daily management is critical to optimize disease outcomes. Little is known about COVID-19 pandemic effects on persons with T1D and their caregivers. We hypothesized caregivers would report increased stress, lower self-efficacy (SE), and more difficult diabetes management associated with the pandemic.     Methods: A 49-item survey using Likert scales and open-ended response questions was distributed via email and T1D-related social media platforms from May 4-June 2,2020 to caregivers of children with T1D <18 years of age. The Patient-Reported Outcomes Measurement Information System (PROMIS) SE short form was used to measure general SE.     Results:  260 caregivers completed surveys: 94.2% female, mean age 42.4±7.7 years, 80.3% college degree or higher, 53.8% annual income >$99,000, 77.3% privately insured. Mean child age 11.0±4.1 years, mean T1D duration 4.2±3.4 years. 24.2% reported having COVID-19 or knowing someone diagnosed with COVID-19. 71.9% reported greater stress than before the pandemic. 9.6% reported job loss, 25.8% financial difficulty related to COVID-19. General SE levels were high, significantly correlated with overall COVID-19-related SE (r=0.394, p<0.001), and T1D care-SE during COVID-19 (r=0.421, p<0.001). 210 respondents provided open-ended response qualitative information on worries: 87.6% reported a worry, remainder not worried.  Common worries were COVID-19-related diabetes complications including uncontrolled blood sugars, diabetic ketoacidosis, and worry about child’s increased risk for severe disease, including death. 209 reported about challenges; 90.9% stated they had at least one challenge. Family isolation and mental health were the most-stated challenges.     Conclusion:  Despite reporting high overall SE, caregivers of T1D children during the pandemic reported greater overall stress, worries, and challenges. Given that data do not suggest that children with T1D are at increased risk of COVID-19 complications, healthcare providers should work to address this knowledge gap while providing families with social and mental health supports. 

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