Qualitative Assessment of Patient-reported Outcomes in Adults With Eosinophilic Esophagitis

2011 ◽  
Vol 45 (9) ◽  
pp. 769-774 ◽  
Author(s):  
Tiffany H. Taft ◽  
Emily Kern ◽  
Laurie Keefer ◽  
David Burstein ◽  
Ikuo Hirano
2017 ◽  
Vol 11 (2) ◽  
pp. 225-234 ◽  
Author(s):  
Martin J. Carney ◽  
Kate E. Golden ◽  
Jason M. Weissler ◽  
Michael A. Lanni ◽  
Andrew R. Bauder ◽  
...  

2016 ◽  
Vol 14 (1) ◽  
pp. 51-60 ◽  
Author(s):  
Alain Schoepfer ◽  
Alex Straumann ◽  
Ekaterina Safroneeva

Author(s):  
Alain M. Schoepfer ◽  
Camilla Schürmann ◽  
Sven Trelle ◽  
Marcel Zwahlen ◽  
Christopher Ma ◽  
...  

<b><i>Background:</i></b> Over the last 20 years, diverse outcome measures have been used to evaluate the effectiveness of therapies for eosinophilic esophagitis (EoE). This systematic review aims to identify the readouts used in observational studies of topical corticosteroids, diet, and dilation in adult EoE patients. <b><i>Methods:</i></b> We searched MEDLINE and Embase for prospective and retrospective studies (cohorts/case series, randomized open-label, and case-control) evaluating the use of diets, dilation, and topical corticosteroids in adults with EoE. Two authors independently assessed the articles and extracted information about histologic, endoscopic, and patient-reported outcomes and tools used to assess treatment effects. <b><i>Results:</i></b> We included 69 studies that met inclusion criteria. EoE-associated endoscopic findings (assessed either as absence/presence or using Endoscopic Reference Score) were evaluated in 24/35, 11/17, and 9/17 studies of topical corticosteroids, diet, and dilation, respectively. Esophageal eosinophil density was recorded in 32/35, 17/17, and 11/17 studies of topical corticosteroids, diet, and dilation, respectively. Patient-reported outcomes were not uniformly used (only in 14, 8, and 3 studies of topical corticosteroids, diet, and dilation, respectively), and most tools were not validated for use in adults with EoE. <b><i>Conclusions:</i></b> Despite the lack of an agreed set of core outcomes that should be recorded and reported in studies in adult EoE patients, endoscopic EoE-associated findings and esophageal eosinophil density are commonly used to assess disease activity in observational studies. Standardization of outcomes and data supporting the use of outcomes are needed to facilitate interpretation of evidence, its synthesis, and comparisons of interventions in meta-analyses of therapeutic trials in adults with EoE.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18068-e18068
Author(s):  
Andrew L. Laccetti ◽  
Rebecca Slack Tidwell ◽  
Nipa P Sheth ◽  
Christopher Logothetis ◽  
Michael VanAlstine

e18068 Background: Wearable activity trackers and frequent interrogation of remote patient reported outcomes (PROs) have the potential to revolutionize oncology clinical trial design, therapeutic sequencing and patient (pt) safety. Established feasibility and novel systems of data processing are necessary to substantiate value for these methods. Methods: Expanding upon our clinical research data platform, Prometheus, we have developed a HIPPA compliant, remote pt monitoring system capable of collecting minute-by-minute step count and heart rate (via Fitbit) in addition to smart phone derived symptom surveys. To pilot this program, a cohort of metastatic castration resistant prostate cancer (mCRPC) pts participated in continuous Fitbit monitoring and thrice weekly NCI-PRO-CTCAE survey for 26 weeks. Pre-specified interim feasibility results were examined with a focus on pt characteristics, treatment and compliance. Qualitative assessment of barriers to pt enrollment and device use was performed. Results: 15 mCRPC pts completed our pilot program: mean age 63.1 years (range 48-79), pre-treatment PSA 33.2 ng/mL (range 0.3 – 499.9), 80.0% stage M1b, ECOG 0 or 1. All pts were treated per protocol NCT02703623: abiraterone/prednisone/apalutamide for 8 weeks followed by continuation of therapy (5 pts), cabazitaxel/carboplatin (6 pts) or addition of ipilimumab (2 pts). 33.3% of pts reported grade 3 clinician interpreted adverse events. 14 pts had data available for compliance analysis. Mean Fitbit compliance was 62.6% (STD 35.5%) with rates trending down over the study duration (week 1 vs 26 = 86.7% vs 33.3%; p= 0.002; R2= 0.716). Mean smart phone derived NCI-PRO-CTCAE survey completion rate was 37.1%. Barriers to pt enrollment included slow Fitbit app download times, incompatible smart phones and the need for extensive device use education/counseling. Barriers to data collection were missed survey text prompts and inconsistent use of Bluetooth. Conclusions: MD Anderson’s novel, home-grown, remote pt monitoring platform, utilizing Fitbit and smart phone derived PROs, is feasible in function and pt use. Automated compliance checks, streamlined enrollment and pt education are critical to future application. This foundational work will facilitate longitudinal signal variation benchmarked against standard monitoring methods, ultimately aiming to improve outcomes and support of discovery through enriched access to pt experience.


2017 ◽  
Vol 225 (4) ◽  
pp. S86-S87
Author(s):  
Martin J. Carney ◽  
Kate E. Golden ◽  
Jason Weissler ◽  
Michael A. Lanni ◽  
Andrew R. Bauder ◽  
...  

2011 ◽  
Vol 140 (5) ◽  
pp. S-239
Author(s):  
Tiffany Taft ◽  
Emily Kern ◽  
Monika A. Kwiatek ◽  
Ikuo Hirano ◽  
Nirmala Gonsalves ◽  
...  

2010 ◽  
Vol 138 (5) ◽  
pp. S-175 ◽  
Author(s):  
Emily Kern ◽  
Tiffany Taft ◽  
Nelson Moy ◽  
Nirmala Gonsalves ◽  
Laurie Keefer ◽  
...  

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