scholarly journals Real-world treatment patterns and patient-reported outcomes in episodic and chronic migraine in Japan: analysis of data from the Adelphi migraine disease specific programme

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Kaname Ueda ◽  
Wenyu Ye ◽  
Louise Lombard ◽  
Atsushi Kuga ◽  
Yongin Kim ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Real World ◽  
Patient Reported Outcomes ◽  
Treatment Patterns ◽  
Patient Reported ◽  
Disease Specific

scholarly journals Patient-Reported Outcomes from a 1-Year, Real-World, Head-to-Head Comparison of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine

2020 ◽  
Vol 11 ◽  
pp. 215013272095993 ◽  
Author(s):  
Andrew M. Blumenfeld ◽  
Atul T. Patel ◽  
Ira M. Turner ◽  
Kathleen B. Mullin ◽  
Aubrey Manack Adams ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Real World ◽  
Patient Reported Outcomes ◽  
Work Productivity ◽  
Preventive Treatment ◽  
Activity Impairment ◽  
Treatment Benefit ◽  
Study Results ◽  
Patient Reported ◽  
Headache Impact

Introduction/Objective: Chronic migraine (CM) is associated with impaired health-related quality of life and substantial socioeconomic burden, but many people with CM are underdiagnosed and do not receive appropriate preventive treatment. OnabotulinumtoxinA and topiramate have demonstrated efficacy (treatment benefit under ideal conditions) for the prevention of headaches in people with CM in clinical trials, but real-world studies suggest markedly different clinical effectiveness (treatment benefit based on a blend of efficacy and tolerability). This study sought to evaluate patient-reported outcomes (PROs) of onabotulinumtoxinA versus topiramate immediate release for people with CM. Methods: FORWARD was a prospective, multicenter, randomized, parallel-group, open-label, phase 4 study comparing onabotulinumtoxinA 155 U every 12 weeks with topiramate 50 to 100 mg/day for ≤36 weeks in people with CM. PROs measured included the Headache Impact Test (HIT-6), 9-item Patient Health Questionnaire Quick Depression Assessment (PHQ-9), Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP), and Functional Impact of Migraine Questionnaire (FIMQ). Results: A total of 282 patients were randomized and treated with onabotulinumtoxinA (n = 140) or topiramate (n = 142). From baseline to week 30, mean HIT-6 test scores improved significantly in patients taking onabotulinumtoxinA compared with topiramate ( P < .001). Improvements in depression over time were observed via larger changes in PHQ-9 scores with onabotulinumtoxinA than topiramate ( P < .001). Work productivity assessed via WPAI:SHP scores revealed significant improvements with onabotulinumtoxinA versus topiramate in Work Productivity Loss ( P = .024) and Activity Impairment ( P < .001) domains. Results from the FIMQ also revealed a larger reduction from baseline with onabotulinumtoxinA vs topiramate ( P < .0001). Conclusion: OnabotulinumtoxinA treatment had more favorable real-world effectiveness than topiramate on depression, headache impact, functioning and daily living, activity, and work productivity. The overall study results suggest that the beneficial effects on a range of PROs are the result of improved effectiveness when onabotulinumtoxinA is used as preventive treatment for CM. Trial Registration: ClinicalTrials.gov: NCT02191579; https://clinicaltrials.gov/ct2/show/NCT02191579

2327-PUB: Real-World Patient-Reported Outcomes (PROs) with Insulin Glargine 300 U/ml (Gla-300) in Basal Bolus-Treated People with Type 2 Diabetes (T2DM): The MAGE Study

Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 2327-PUB ◽  
Author(s):  
ANN A. VERHAEGEN ◽  
ANDRÉ SCHEEN ◽  
KATHY C. ALEXANDRE ◽  
JACQUES BRUHWYLER ◽  
IDES M. COLIN
Keyword(s):  
Type 2 Diabetes ◽  
Insulin Glargine ◽  
Real World ◽  
Patient Reported Outcomes ◽  
Patient Reported ◽  
Basal Bolus

scholarly journals OMERACT Endorsement of Patient-reported Outcome Instruments in Antineutrophil Cytoplasmic Antibody–associated Vasculitis

2017 ◽  
Vol 44 (10) ◽  
pp. 1529-1535 ◽  
Author(s):  
Joanna C. Robson ◽  
Gunnar Tomasson ◽  
Nataliya Milman ◽  
Sue Ashdown ◽  
Annelies Boonen ◽  
...  
Keyword(s):  
Physical Functioning ◽  
Working Group ◽  
Patient Reported Outcomes ◽  
Controlled Trial ◽  
Antineutrophil Cytoplasmic Antibody ◽  
Pain Interference ◽  
Disease Assessment ◽  
Measurement Information ◽  
Patient Reported ◽  
Disease Specific

Objective.The antineutrophil cytoplasmic antibody–associated vasculitides (AAV) are multiorgan diseases. Patients with AAV report impairment in their health-related quality of life (HRQOL) and have different priorities regarding disease assessment compared with physicians. The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group previously received endorsement for a core set of domains in AAV. Two approaches to measure patient-reported outcomes (PRO) were presented at OMERACT 2016.Methods.A novel 5-step tool was used to facilitate assessment of the instruments by delegates: the OMERACT Filter 2.0 Instrument Selection Algorithm, with a red-amber-green checklist of questions, including (1) good match with domain (face and content validity), (2) feasibility, (3) do numeric scores make sense (construct validity)?, (4) overall ratings of discrimination, and (5) can individual thresholds of meaning be defined? Delegates gave an overall endorsement. Three generic Patient-Reported Outcomes Measurement Information System (PROMIS) instruments (fatigue, physical functioning, and pain interference) and a disease-specific PRO, the AAV-PRO (6 domains related to symptoms and HRQOL), were presented.Results.OMERACT delegates endorsed the use of the PROMIS instruments for fatigue, physical functioning, and pain interference (87.6% overall endorsement) and the disease-specific AAV-PRO instrument (89.4% overall endorsement).Conclusion.The OMERACT Vasculitis Working Group gained endorsement by OMERACT for use of the PROMIS and the AAV-PRO in clinical trials of vasculitis. These instruments are complementary to each other. The PROMIS and the AAV-PRO need further work to assess their utility in longitudinal settings, including their ability to discriminate between treatments of varying efficacy in the setting of a randomized controlled trial.

scholarly journals A Real-World Rheumatology Registry and Research Consortium: The German RHADAR Registry (Preprint)

2021 ◽  
Author(s):  
Stefan Kleinert ◽  
Peter Bartz-Bazzanella ◽  
Cay von der Decken ◽  
Johannes Knitza ◽  
Torsten Witte ◽  
...  
Keyword(s):  
Real World ◽  
Patient Reported Outcomes ◽  
Closed Loop ◽  
Musculoskeletal Diseases ◽  
Closed Loop System ◽  
Real World Data ◽  
Patient Centered ◽  
Patient Reported ◽  
Integrated Medical Care ◽  
Research Consortium

UNSTRUCTURED Real-world data is crucial to continuously improve patients' management with rheumatic and musculoskeletal diseases (RMD). The German RHADAR registry encompasses a network of rheumatologists and researchers in Germany providing pseudonymized real-world patient data and allowing a timely and continuous improvement in RMD patients' care. The RHADAR modules allow automated anamnesis and adaptive coordination of appointments regarding individual urgency levels. Further modules focus on the collection and integration of electronic patient-reported outcomes in between consultations. The digital RHADAR modules ultimately allow a patient-centered, adaptive approach to integrated medical care starting as early as possible in the disease course. Such a closed-loop system consisting of various modules along the whole patient pathway enables comprehensive and timely patient management in an unprecedented manner.

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