P124 COMPARISONS OF HOLISTIC PATIENT-REPORTED OUTCOMES BY BIOLOGIC DRUG CLASS IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE: A REAL-WORLD STUDY IN IBD PARTNERS

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S23-S24
Author(s):  
Millie Long ◽  
Xian Zhang ◽  
Wenli Chen ◽  
Trevor Lissoos
Keyword(s):  
Real World ◽  
Patient Reported Outcomes ◽  
Drug Class ◽  
Disease Duration ◽  
Pain Interference ◽  
Longitudinal Analyses ◽  
Social Satisfaction ◽  
Patient Reported ◽  
Anxiety Depression

Abstract Background Increasing numbers of biologic agents are now available for the treatment of Crohn’s disease (CD) and ulcerative colitis (UC). Limited data are available on clinical characteristics of populations initiating these therapies and relevant holistic patient-reported outcomes (PROs) in the real-world. Methods We used data from IBD Partners from May 2014-May 2019. Individuals initiating an anti-tumor necrosis factor (anti-TNF) agent or vedolizumab (VDZ) were included. A subgroup with at least 6 months of follow-up who had baseline data within 90 days of therapy initiation were included in longitudinal analyses. We aimed to: 1) compare clinical characteristics of patients initiating each biologic therapy and 2) compare PROs at follow-up by drug class. Outcomes included Patient-Reported Outcomes Measurement Information System (PROMIS) T scores for anxiety, depression, fatigue, pain interference, and social satisfaction. We used logistic regression models controlling for prior biologic exposure, age, sex, prior hospitalization, disease duration, surgery (for CD), and baseline values of each PRO to compare PROs at follow-up by drug class. Levels of each PRO within a half standard deviation of the general population T score represented wellness. Results A total of 878 patients initiating anti-TNF (625 CD, 253 UC) and 651 initiating VDZ (415 CD, 236 UC) were included. Patients with CD initiating VDZ were more likely to be older, had longer disease duration, increased IBD-related hospitalization, more prior surgeries, and were more likely to be biologic exposed (P<0.05 for all). Patients with UC initiating VDZ were more likely to be male and biologic exposed (P<0.05 for both) (Table 1). In longitudinal analyses, a total of 198 patients on anti-TNF and 168 on VDZ were included for CD; a total of 85 on anti-TNF and 96 on VDZ were included for UC. Individuals with CD initiating VDZ had significantly greater fatigue, pain interference, and reduced social satisfaction at baseline compared with the anti-TNF population. For UC, PROs at baseline were similar across drug groups. In both CD and UC, there were no significant differences in adjusted odds of wellness for each PRO at follow-up by drug class (Table 2). Conclusions CD patients initiating VDZ in this real-world cohort had multiple factors consistent with more severe disease compared with those initiating anti-TNF. In longitudinal analyses after at least 6 months of treatment with VDZ or anti-TNF, there were no differences in wellness of PROs, such as anxiety, depression, fatigue, pain interference, or social satisfaction by drug class for CD or UC.

Impact of Preoperative Opioid Use on 2-Year Patient-Reported Outcomes in Knee Surgery Patients

2020 ◽  
Author(s):  
Ali Aneizi ◽  
Patrick M. J. Sajak ◽  
Aymen Alqazzaz ◽  
Tristan Weir ◽  
Cameran I. Burt ◽  
...  
Keyword(s):  
Physical Function ◽  
Patient Reported Outcomes ◽  
Knee Surgery ◽  
The Body ◽  
Pain Interference ◽  
Opioid Use ◽  
Opioid Prescription ◽  
Social Satisfaction ◽  
Patient Reported ◽  
Met Expectations

AbstractThe objectives of this study are to assess perioperative opioid use in patients undergoing knee surgery and to examine the relationship between preoperative opioid use and 2-year postoperative patient-reported outcomes (PROs). We hypothesized that preoperative opioid use and, more specifically, higher quantities of preoperative opioid use would be associated with worse PROs in knee surgery patients. We studied 192 patients undergoing knee surgery at a single urban institution. Patients completed multiple PRO measures preoperatively and 2-year postoperatively, including six patient-reported outcomes measurement information system (PROMIS) domains; the International Knee Documentation Committee (IKDC) questionnaire, numeric pain scale (NPS) scores for the operative knee and the rest of the body, Marx's knee activity rating scale, Tegner's activity scale, International Physical Activity Questionnaire, as well as measures of met expectations, overall improvement, and overall satisfaction. Total morphine equivalents (TMEs) were calculated from a regional prescription monitoring program. Eighty patients (41.7%) filled an opioid prescription preoperatively, and refill TMEs were significantly higher in this subpopulation. Opioid use was associated with unemployment, government insurance, smoking, depression, history of prior surgery, higher body mass index, greater comorbidities, and lower treatment expectations. Preoperative opioid use was associated with significantly worse 2-year scores on most PROs, including PROMIS physical function, pain interference, fatigue, social satisfaction, IKDC, NPS for the knee and rest of the body, and Marx's and Tegner's scales. There was a significant dose-dependent association between greater preoperative TMEs and worse scores for PROMIS physical function, pain interference, fatigue, social satisfaction, NPS body, and Marx's and Tegner's scales. Multivariable analysis confirmed that any preoperative opioid use, but not quantity of TMEs, was an independent predictor of worse 2-year scores for function, activity, and knee pain. Preoperative opioid use and TMEs were neither independent predictors of met expectations, satisfaction, patient-perceived improvement, nor improvement on any PROs. Our findings demonstrate that preoperative opioid use is associated with clinically relevant worse patient-reported knee function and pain after knee surgery.

Implementing routine assessment of patient-reported outcomes in cancer care.

2017 ◽  
Vol 35 (8_suppl) ◽  
pp. 229-229 ◽  
Author(s):  
Kathi Mooney ◽  
Joshua Biber ◽  
Rachel Hess ◽  
Howard Weeks ◽  
John W. Sweetenham
Keyword(s):  
Cancer Care ◽  
Patient Reported Outcomes ◽  
Clinic Visit ◽  
Computer Assisted ◽  
Patient Reported ◽  
Reported Data ◽  
Time Critical ◽  
Anxiety Depression ◽  
Routine Assessment

229 Background: Value based cancer care includes measurement of value to the patient. Patient reported outcomes (PRO) are central to assessing outcomes of cancer care but systematically measuring them creates adoption and work flow issues. We report the Huntsman Cancer Institute’s (HCI) experience implementing routine collection of PROs. Methods: Patients on a quarterly basis either prior to a scheduled visit via email or at the visit via tablet, complete 5 PROMIS measures (fatigue, pain interference, anxiety, depression and physical function) administered in computer-assisted test (CAT) format. Patients also complete a current health visual analog scale and general health question. Data are automatically and seamlessly populated to the electronic health record (EHR) for clinician review at the visit and are stored within the data warehouse. Results: Roll-out began sequentially to all HCI oncology outpatient clinics in July 2016, with a new clinic added every 2 weeks. To date PRO assessment is operational in every HCI clinic with over 9,800 assessments completed by 8,600 patients. Most assessments have been completed in the clinic as at-home completion was a recent option. Time to complete assessments average 5 minutes. Findings to date demonstrate that HCI patients are within average norms for cancer patients on the measures. Approximately 3% of depression assessments were at an elevated level and automatically routed to social work for follow-up. Initial assessments will serve as the basis for tracking quality improvement initiatives in the future. Missed assessments were common during initial startup. Completion was more likely when the clinicians valued having the data during the clinic visit and made it an expectation for collection by front end staff at visit registration. Conclusions: Technology-aided patient reported outcomes can be systematically and successfully collected during outpatient care, with triage of scores beyond acceptable thresholds for follow-up. Baseline scores will serve to evaluate improvements in care over time. Critical to success are clinical champions who value and understand the scoring and interpretation of patient reported data and make staff facilitation of data collection an expectation.

Understanding characteristics of patients newly initiating ixekizumab: findings from the Corrona Psoriasis Registry

2020 ◽  
Author(s):  
Jashin J Wu ◽  
Ryan W Harrison ◽  
Baojin Zhu ◽  
Orin M Goldblum ◽  
William N Malatestinic ◽  
...  
Keyword(s):  
Surface Area ◽  
Body Surface Area ◽  
Body Surface ◽  
Real World ◽  
Patient Reported Outcomes ◽  
Disease Duration ◽  
Severe Disease ◽  
Work Productivity ◽  
Real World Data ◽  
Patient Reported

Background: Real-world data on patients newly initiating ixekizumab is limited. Our study describes the characteristics of patients who initiated ixekizumab and other biologics for psoriasis treatment in North American dermatological practices. Materials & methods: Characteristics of patients ascertained at registry enrollment are described via means and frequencies. Results: Compared with other biologic initiators, ixekizumab initiators had: longer disease duration (17.1 vs 15.1 years); more were considered least severe by body surface area (33 vs 26%); moderate-to-severe by IGA (56 vs 48%); were biologic-experienced (80 vs 52%); obese (54 vs 47%); and experienced greater impact in work productivity (5.3 vs 2.9%) versus other biologic initiators. Conclusion: Psoriasis patients initiating ixekizumab had more severe disease, biologic experience, and worse patient-reported outcomes than those initiating other biologics.

Anti-IL-6 Therapy Effect for Refractory Joint and Skin Involvement in Systemic Sclerosis: A Real-world, Single Center Experience

2021 ◽  
pp. jrheum.210273
Author(s):  
Stylianos T. Panopoulos ◽  
Maria G. Tektonidou ◽  
Vasiliki-Kalliopi Bournia ◽  
Aikaterini Arida ◽  
Petros P. Sfikakis
Keyword(s):  
Systemic Sclerosis ◽  
Real World ◽  
Disease Duration ◽  
Retention Rates ◽  
Skin Involvement ◽  
Hematopoietic Stem ◽  
Single Center Experience ◽  
Therapy Effect ◽  
Patient Reported

Objective To examine the efficacy and safety of interleukin-6 inhibition by tocilizumab in difficult-to-treat real-world patients with Systemic Sclerosis (SSc). Methods Twenty-one patients [20 women, 16 diffuse SSc, mean age: 52±10 years, 10 with early (<5 years) and 11 with long-standing disease (mean disease duration: 6.4±3.7 years)] with active joint and/or skin involvement refractory to corticosteroids (n=21), methotrexate (n=19), cyclophosphamide (n=10), mycophenolate (n=7), rituximab (n=1), leflunomide (n=2), hydroxychloroquine (n=2), and hematopoietic stem cell transplantation (n=2) who received weekly tocilizumab (162 mg subcutaneously) in an academic center, were monitored prospectively. Changes in modified Rodnan skin score (mRSS), disease activity score (DAS)28, lung function tests (LFTs) and patient reported outcomes (PROs) were analyzed after one year of treatment and at follow-up end. Results One patient discontinued tocilizumab after 3 months due to inefficacy. During the first year of treatment, improvement was evident in the remaining 20 patients regarding skin involvement (mean mRSS change: -6.9±5.9,p<0.001), polyarthritis (mean DAS28 change: -1.9±0.8,p<0.001) and PROs (all p<0.001); LFTs stabilization was observed in 16/20 patients. During the second year, 3 patients discontinued tocilizumab (cytomegalovirus infection in 1, inefficacy in 2) and one died. Beneficial effects were sustained in all 16 patients at follow-up end (2.2±1.1 years), except LFTs deterioration in 3. Apart from recurrent digital ulcer infection in 3 patients, tocilizumab was well-tolerated. Conclusion Tocilizumab was effective in refractory joint and skin involvement irrespective of SSc disease duration or subtype. Long-term retention rates and disease stabilization for most real-world patients suggest that tocilizumab might be a valuable choice for difficult-to-treat SSc.

P048 QUALITY OF LIFE AND OTHER PATIENT REPORTED OUTCOMES IN PATIENTS WITH POUCHITIS

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S65-S66
Author(s):  
Edward Barnes ◽  
Millie Long ◽  
Laura Raffals ◽  
Xian Zhang ◽  
Anuj Vyas ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Sleep Disturbance ◽  
Patient Reported Outcomes ◽  
Pain Interference ◽  
Social Emotional ◽  
Specific Patient ◽  
Social Satisfaction ◽  
Patient Reported ◽  
Global Quality Of Life

Abstract Background While restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the preferred surgical approach in patients with medically refractory ulcerative colitis (UC) or UC-related dysplasia, a significant proportion of patients develop pouchitis and/or report decreased health related quality of life (HRQOL) at some point after IPAA. We designed this study to 1) evaluate the association between recently reported pouchitis and specific Patient-Reported Outcome Measurement Information System (PROMIS) domains (anxiety, depression, fatigue, pain interference, sleep disturbance, and social role satisfaction) and HRQOL as assessed by the Cleveland Global Quality of Life (CGQL) scale, and 2) describe the correlations between specific PROMIS domains and overall HRQOL. Methods IBD Partners is an internet-based cohort that collects patient reported survey data every 6 months. In patients who reported having an IPAA for UC, we performed cross sectional analyses to compare patient characteristics and patient reported outcomes among patients who reported pouchitis in the prior 6 months versus those without reported pouchitis. To identify the specific social, emotional, and physical domains most associated with HRQOL, we evaluated the correlations between PROMIS domains (measured in T-scores) and CGQL scores using Pearson’s test. Results Among 118 patients, 70 (59%) reported pouchitis in the prior 6 months. There were no significant differences in age, sex, race, or number of stages of IPAA between patients with and without recent pouchitis (Table 1). Patients with recent pouchitis were more likely to demonstrate higher levels of anxiety (53.8 vs. 48.5, p=0.005), depression (52.2 vs. 46.9, p=0.005), fatigue (55.8 vs. 47.8, p&lt;0.001), pain interference (54.4 vs. 48.1, p=0.001), sleep disturbance (54.3 vs. 48.8, p=0.001), and lower levels of social satisfaction (47.4 vs. 53.6, p=0.001). As assessed by the CGQL, patients with pouchitis demonstrated decreased Quality of Life (6.64 vs. 7.71, p=0.007), Quality of Health (6.31 vs. 7.63, p=0.001), and Quality of Energy (5.77 vs. 7.17, p=0.001). Social satisfaction was the PROMIS domain that most strongly correlated with Quality of Life among patients with recent pouchitis (r= 0.62, Table 2) while sleep demonstrated the strongest correlation among those without pouchitis (r= -0.74). Conclusions Patients with recent pouchitis demonstrated a significant reduction in overall HRQOL as well as decrements in specific areas of social, emotional, and physical health. Among patients without pouchitis, strong correlations between multiple PROMIS domains and HRQOL were also demonstrated. These findings indicate that the PROMIS measures may be useful in assessing these areas of health that are clinically important after IPAA, allowing for tailored interventions in this population.

scholarly journals Changes in Patient-Reported Outcomes With Vedolizumab Therapy in Patients With Inflammatory Bowel Diseases (IBD): Results From the IBD Partners Patient Powered Research Network

2019 ◽  
Vol 1 (2) ◽  
Author(s):  
Millie D Long ◽  
Christopher F Martin ◽  
Wenli Chen ◽  
Michelle Luo
Keyword(s):  
Odds Ratio ◽  
Patient Reported Outcomes ◽  
Adjusted Odds Ratio ◽  
Research Network ◽  
Social Satisfaction ◽  
Patient Reported ◽  
Remission Rates ◽  
Bowel Diseases ◽  
Inflammatory Bowel

Abstract Background We described changes in patient-reported outcomes (PROs) with vedolizumab (VDZ) use in inflammatory bowel disease (IBD). Methods We included patients initiating VDZ with at least 6 months of follow-up in the IBD Partners cohort. We stratified by biologic naive (BN) or biologic exposed (BE) status. Outcomes included PROs. Results We included 380 patients with IBD. Remission rates at follow-up were higher for BN versus BE (65.1% vs 45.5%, P &lt; 0.01). BN patients experienced significant improvements in social satisfaction (P &lt; 0.01). BN status was associated with remission (adjusted odds ratio, 3.36; 95% confidence interval, 1.67–6.77). Conclusions Improvements in PROs were seen with VDZ, particularly in BN populations.

scholarly journals The longitudinal relationship between patient-reported outcomes and clinical characteristics among patients with focal segmental glomerulosclerosis in the Nephrotic Syndrome Study Network

2019 ◽  
Vol 13 (4) ◽  
pp. 597-606
Author(s):  
Jonathan P Troost ◽  
Anne Waldo ◽  
Noelle E Carlozzi ◽  
Shannon Murphy ◽  
Frank Modersitzki ◽  
...  
Keyword(s):  
Nephrotic Syndrome ◽  
Global Health ◽  
Focal Segmental Glomerulosclerosis ◽  
Patient Reported Outcomes ◽  
Pain Interference ◽  
Social Satisfaction ◽  
Sleep Impairment ◽  
Segmental Glomerulosclerosis ◽  
Patient Reported ◽  
Multivariable Analyses

Abstract Background Understanding the relationship between clinical and patient-reported outcomes (PROs) will help support clinical care and future clinical trial design of novel therapies for focal segmental glomerulosclerosis (FSGS). Methods FSGS patients ≥8 years of age enrolled in the Nephrotic Syndrome Study Network completed Patient-Reported Outcomes Measurement Information System PRO measures of health-related quality of life (HRQoL) (children: global health, mobility, fatigue, pain interference, depression, anxiety, stress and peer relationships; adults: physical functioning, fatigue, pain interference, sleep impairment, mental health, depression, anxiety and social satisfaction) at baseline and during longitudinal follow-up for a maximum of 5 years. Linear mixed-effects models were used to determine which demographic, clinical and laboratory features were associated with PROs for each of the eight children and eight adults studied. Results There were 45 children and 114 adult FSGS patients enrolled that had at least one PRO assessment and 519 patient visits. Multivariable analyses among children found that edema was associated with global health (−7.6 points, P = 0.02) and mobility (−4.2, P = 0.02), the number of reported symptoms was associated with worse depression (−2.7 per symptom, P = 0.009) and anxiety (−2.3, P = 0.02) and the number of emergency room (ER) visits in the prior 6 months was associated with worse mobility (−2.8 per visit, P &lt; 0.001) and fatigue (−2.4, P = 0.03). Multivariable analyses among adults found the number of reported symptoms was associated with worse function in all eight PROMIS measures and the number of ER visits was associated with worse fatigue, pain interference, sleep impairment, depression, anxiety and social satisfaction. Laboratory markers of disease severity (i.e. proteinuria, estimated glomerular filtration rate and serum albumin) did not predict PRO in multivariable analyses, with the single exception of complete remission and better pain interference scores among children (+9.3, P = 0.03). Conclusions PROs provide important information about HRQoL for persons with FSGS that is not captured solely by the examination of laboratory-based markers of disease. However, it is critical that instruments capture the patient experience and FSGS clinical trials may benefit from a disease-specific instrument more sensitive to within-patient changes.

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