An Open-Source Web Portal for Managing Self-reported Data and Real-world Data Donation in Diabetes Research: Feasibility Study. (Preprint)

2021 ◽  
Author(s):  
Drew Cooper ◽  
Tebbe Ubben ◽  
Christine Knoll ◽  
Hanne Ballhausen ◽  
Shane O'Donnell ◽  
...  
Keyword(s):  
Healthcare Professional ◽  
Data Management ◽  
Open Source ◽  
Medical Device ◽  
Real World ◽  
Diabetes Research ◽  
Real World Data ◽  
Follow Up Studies ◽  
Reported Data

BACKGROUND People with diabetes and their support networks have developed open-source automated insulin delivery systems to help manage their diabetes therapy, as well as to improve their quality of life and glycemic outcomes. Under the hashtag #WeAreNotWaiting, a wealth of knowledge and real-world data has been generated by users of these systems but has been left largely untapped by research; the opportunity for multimodal studies investigating this group remains open. OBJECTIVE Developing a mixed-methods study to evaluate several aspects of open-source automated insulin delivery presents challenges relating to data management and security across multiple disparate online platforms, and implementation of follow-up studies with study participants. This research article reports on the feasibility of such a multimodal concept. METHODS A web portal was developed to manage both front-end participant interactions with study elements and back-end data management of survey responses and donated anonymized diabetes data. Participant data in REDCap and Open Humans was pseudonymously and securely linked and stored within a custom-built database using both open-source and commercial software. Participants—which included adults and children with diabetes, their partners and caregivers—were recruited through multiple online diabetes community groups. Participants were later given the option to include their healthcare providers in the study; database architecture was designed specifically with this kind of extensibility in mind. RESULTS Of 1052 visitors to the study landing page, 930 participated and completed at least one or multiple questionnaires. After the implementation of healthcare professional validation of self-reported clinical outcomes to the study, an additional 145 individuals visited the landing page, with 124 completing at least one or multiple questionnaires. Of the optional study elements, 7 participant-healthcare professional dyads participated in the survey, and 97 participants who completed the survey joined Open Humans to also donate their anonymized medical device data. CONCLUSIONS The study design proved successful in being both accessible for participants and manageable for researchers while maintaining compliance with data regulations. The gateway proved scalable when tested with the later addition of validation of self-reported data. Custom software solutions like the gateway may become increasingly common in diabetes research, especially with medical device data donation and follow-up studies. The gateway portal code has been made available open-source and can also be leveraged by other research projects.

scholarly journals An Open-Source Web Portal for Managing Self-reported Data and Real-world Data Donation in Diabetes Research: Feasibility Study. (Preprint)

JMIR Diabetes ◽  
10.2196/33213 ◽  
2021 ◽  
Author(s):  
Drew Cooper ◽  
Tebbe Ubben ◽  
Christine Knoll ◽  
Hanne Ballhausen ◽  
Shane O'Donnell ◽  
...  
Keyword(s):  
Open Source ◽  
Feasibility Study ◽  
Real World ◽  
Diabetes Research ◽  
Web Portal ◽  
Real World Data ◽  
World Data ◽  
Reported Data

1043-P: Glycemic Profiles and Treatment Patterns: Real-World Data from 8,020 Adults with Type 1 Diabetes Using the Omnipod® Insulin Management System with Cloud-Based Data Management

Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 1043-P
Author(s):  
JENNIFER E. LAYNE ◽  
JIALUN HE ◽  
JAY JANTZ ◽  
YIBIN ZHENG ◽  
ERIC BENJAMIN ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Data Management ◽  
Real World ◽  
Management System ◽  
Treatment Patterns ◽  
Real World Data ◽  
World Data

928-P: Dulaglutide Has Higher Adherence and Persistence than Semaglutide and Exenatide QW: 6-Month Follow-Up from U.S. Real-World Data

Diabetes ◽  
2020 ◽  
Vol 69 (Supplement 1) ◽  
pp. 928-P
Author(s):  
REEMA MODY ◽  
MARIA YU ◽  
BAL K. NEPAL ◽  
MANIGE KONIG ◽  
MICHAEL GRABNER
Keyword(s):  
Real World ◽  
Real World Data ◽  
World Data ◽  
Exenatide Qw

scholarly journals Long Term Real-World Outcomes of Trifluridine/Tipiracil in Metastatic Colorectal Cancer—A Single UK Centre Experience

2021 ◽  
Vol 28 (3) ◽  
pp. 2260-2269
Author(s):  
Daniel Tong ◽  
Lei Wang ◽  
Jeewaka Mendis ◽  
Sharadah Essapen
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Real World ◽  
Systemic Treatment ◽  
Progression Free Survival ◽  
Median Number ◽  
Current Data ◽  
Real World Data

In the UK, Trifluridine-tipiracil (Lonsurf) is used to treat metastatic colorectal cancer in the third-line setting, after prior exposure to fluoropyrimidine-based regimes. Current data on the real-world use of Lonsurf lack long-term follow-up data. A retrospective evaluation of patients receiving Lonsurf at our Cancer Centre in 2016–2017 was performed, all with a minimum of two-year follow-up. Fifty-six patients were included in the review. The median number of cycles of Lonsurf administered was 3. Median follow-up was 6.0 months, with all patients deceased at the time of analysis. Median progression-free survival (PFS) was 3.2 months, and overall survival (OS) was 5.8 months. The median interval from Lonsurf discontinuation to death was two months, but seven patients received further systemic treatment and median OS gained was 12 months. Lonsurf offered a slightly better PFS but inferior OS to that of the RECOURSE trial, with PFS similar to real-world data previously presented. Interestingly, 12.5% had a PFS > 9 months, and this cohort had primarily left-sided and RAS wild-type disease. A subset received further systemic treatment on Lonsurf discontinuation with good additional OS benefit. Lonsurf may alter the course of disease for a subset of patients, and further treatment on progression can be considered in carefully selected patients.

scholarly journals Real world experience with coronary sinus reducer implantation for the treatment of refractory angina: a single-centre experience

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
J P Dias Ferreira Reis ◽  
R Ramos ◽  
P Rio ◽  
A Fiarresga ◽  
D Cacela ◽  
...  
Keyword(s):  
Coronary Sinus ◽  
Real World ◽  
Therapeutic Option ◽  
Objective Evaluation ◽  
Short Version ◽  
Refractory Angina ◽  
Single Centre ◽  
Real World Data ◽  
Serious Adverse Events

Abstract Background Coronary sinus Reducer device (CSF) implantation is a novel therapeutic option to relieve symptoms in patients with refractory angina (RA). There is limited real-world data describing its use outside of clinical trials. Aim To assess the safety and efficacy of this procedure in a real-world setting. Methods This is a report of a single centre prospective registry of consecutive patients with RA (CCS II-IV) deemed unsuitable for revascularization. Between May 2017 and August 2019, 17 patients were referred to CSF implantation. Baseline and follow-up evaluation consisted of clinical assessment, including completion of the short version of the Seattle Angina Questionnaire (SAQ-7) and CCS class evaluation and objective evaluation by transthoracic echocardiography and cardiopulmonary exercise test (CPET). Results A total of 13 patients (70,6±6,5 years, 76,9% male) underwent CSF implantation with a procedural success of 84.6%. No cases of periprocedural serious adverse events were reported. At 12-month follow-up, any reduction in CCS Class was achieved in 72.7% of cases, with 27.2% reducing 2 CCS classes. Baseline CCS score was reduced from 2.8±0.4 to 1.7±0.8 (p=0.009). Quality of life (QoL) was significantly improved as assessed by the improvement seen in all items of SAQ-7 (p<0.017 for all). CPET duration was significantly increased (p=0.034), but no change was noted in the remainder CPET variables. During follow-up, 3 patients suffered myocardial infarction, resulting in 1 death. Conclusion CSF implantation in patients with RA was safe and led to a significant reduction of the angina burden and improvement of QoL at 12-month follow-up. FUNDunding Acknowledgement Type of funding sources: None.

FRI0362 COMPARATIVE EFFECTIVENESS OF USTEKINUMAB (UST) AND TNF INHIBITORS (TNFI) IN PATIENTS WITH PSORIATIC ARTHRITIS (PSA) IN THE REAL-WORLD, MULTINATIONAL PSABIO STUDY: 12-MONTH FOLLOW-UP

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 778-779
Author(s):  
J. S. Smolen ◽  
S. Siebert ◽  
T. Korotaeva ◽  
P. Bergmans ◽  
K. De Vlam ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Real World ◽  
Activity Index ◽  
Treatment Options ◽  
Disease Activity Index ◽  
Rapid Screening ◽  
Research Support ◽  
Real World Data

Background:Among treatment options for PsA, IL-12/23 inhibition with UST was the first new biologic mode of action after TNFi. Few real-world data comparing UST with TNFi are available.Objectives:Comparison of UST and TNFi treatment effectiveness within the prospectively followed PsABio cohort at 12-month (mo) follow-up.Methods:The PsABio study (NCT02627768) evaluates effectiveness, tolerability and persistence of 1st, 2nd or 3rd-line UST or TNFi in PsA. Proportions of patients (pts) reaching MDA/very low disease activity (VLDA) and clinical Disease Activity index for PSoriatic Arthritis (cDAPSA) LDA/remission are described. Comparison across UST and TNFi cohorts was done on last observation carried forward up to 12 (±3) mo, with non-response imputation for pts who had stopped/switched initial treatment. Logistic regression analysis was used, including propensity score (PS) analysis to adjust for imbalanced prognostic baseline (BL) covariates: country, age, sex, BMI, smoking (yes/no), comorbidities (cardiovascular/metabolic syndrome), PsA type (axial, polyarticular, oligoarticular), psoriasis body surface area (BSA), disease duration, cDAPSA, 12-item PsA Impact of Disease (PsAID-12), dactylitis, enthesitis, Fibromyalgia Rapid Screening Tool (FiRST) score, line of biologic (b)DMARD, synthetic DMARD use, and steroid or NSAID use.Results:Of 929 eligible pts, 893 had evaluable data at BL and at follow-up; 438 (95.6%) were treated with UST and 455 (96.6%) with TNFi (including stoppers/switchers). UST and TNFi groups had BL differences in mean age (51.0 vs 48.5 years, respectively), concurrent comorbidities (68.7% vs 60.9%), time since diagnosis (7.5 vs 6.2 years), line of treatment (1st-line 45.0% vs 55.2%; 3rd-line 20.5% vs 12.1%), NSAID use (54.8% vs 68.8%), concomitant MTX use (29.9% vs 42.0%) and psoriasis skin involvement (BSA >10% in 26.6% vs 14.8%).In 714 pts with available data, mean (standard deviation) BL cDAPSA was 30.6 (20.2; n=358) for UST and 29.3 (18.6; n=356) for TNFi. Observed data showed differences in proportion of pts achieving MDA/VLDA and cDAPSA LDA/remission in favour of TNFi, but after PS adjustment for BL differences (such as line of therapy, skin psoriasis, concomitant conventional DMARD, etc.), odds ratios for reaching targets at 12 mo did not significantly differ between UST and TNFi groups (Fig. 1).Comparison of 6- and 12-mo unadjusted data showed sustained MDA/VLDA responses with both UST (21.8%) and TNFi (29.5%), with comparable proportions of additional pts achieving these targets between 6 and 12 mo (17.0% and 20.3%, respectively). Sustained efficacy became lower with successive lines of treatment (data not shown).Conclusion:Various factors, including patient characteristics such as comorbidities, influence the physician’s selection of treatment modality for patients needing a bDMARD. Our real-world results demonstrate differences in observed clinical effectiveness between UST and TNFi. However, after PS adjustment for a number of BL differences, clinical results at 12 mo were comparable between UST and TNFi groups. Data at 12 mo also show sustained response with both UST and TNFi treatment, as well as a similar rate of pts achieving targets after 6 to 12 mo of treatment.Acknowledgments:This study was funded by Janssen.Disclosure of Interests:Josef S. Smolen Grant/research support from: AbbVie, AstraZeneca, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO, Janssen, Novartis-Sandoz, Pfizer Inc, Samsung, Sanofi, Consultant of: AbbVie, AstraZeneca, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO, Janssen, Novartis-Sandoz, Pfizer Inc, Samsung, Sanofi, Stefan Siebert Grant/research support from: BMS, Boehringer Ingelheim, Celgene, GlaxoSmithKline, Janssen, Novartis, Pfizer, UCB, Consultant of: AbbVie, Boehringer Ingelheim, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Celgene, Janssen, Novartis, Tatiana Korotaeva Grant/research support from: Pfizer, Consultant of: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Speakers bureau: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Paul Bergmans Shareholder of: Johnson & Johnson, Employee of: Janssen, Kurt de Vlam Consultant of: Celgene Corporation, Eli Lilly, Novartis, Pfizer, UCB – consultant, Speakers bureau: Celgene Corporation, Eli Lilly, Novartis, Pfizer, UCB – speakers bureau and honoraria, Elisa Gremese Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Sanofi, UCB, Roche, Pfizer, Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Sanofi, UCB, Roche, Pfizer, Beatriz Joven-Ibáñez Speakers bureau: Abbvie, Celgene, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Wim Noel Employee of: Janssen Pharmaceuticals NV, Michael T Nurmohamed Grant/research support from: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Consultant of: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Speakers bureau: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Petros Sfikakis Grant/research support from: Grant/research support from Abvie, Novartis, MSD, Actelion, Amgen, Pfizer, Janssen Pharmaceutical, UCB, Elke Theander Employee of: Janssen-Cilag Sweden AB, Laure Gossec Grant/research support from: Lilly, Mylan, Pfizer, Sandoz, Consultant of: AbbVie, Amgen, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Sandoz, Sanofi-Aventis, UCB

scholarly journals Application of Health Technology Assessment (HTA) to Evaluate New Laboratory Tests in a Health System: A Case Study of Bladder Cancer Testing

2020 ◽  
Vol 7 ◽  
pp. 237428952096822
Author(s):  
Erik J. Landaas ◽  
Ashley M. Eckel ◽  
Jonathan L. Wright ◽  
Geoffrey S. Baird ◽  
Ryan N. Hansen ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Pilot Study ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
Health Technology ◽  
Test System ◽  
Real World Data ◽  
World Data

We describe the methods and decision from a health technology assessment of a new molecular test for bladder cancer (Cxbladder), which was proposed for adoption to our send-out test menu by urology providers. The Cxbladder health technology assessment report contained mixed evidence; predominant concerns were related to the test’s low specificity and high cost. The low specificity indicated a high false-positive rate, which our laboratory formulary committee concluded would result in unnecessary confirmatory testing and follow-up. Our committee voted unanimously to not adopt the test system-wide for use for the initial diagnosis of bladder cancer but supported a pilot study for bladder cancer recurrence surveillance. The pilot study used real-world data from patient management in the scenario in which a patient is evaluated for possible recurrent bladder cancer after a finding of atypical cytopathology in the urine. We evaluated the type and number of follow-up tests conducted including urine cytopathology, imaging studies, repeat cystoscopy evaluation, biopsy, and repeat Cxbladder and their test results. The pilot identified ordering challenges and suggested potential use cases in which the results of Cxbladder affected a change in management. Our health technology assessment provided an objective process to efficiently review test performance and guide new test adoption. Based on our pilot, there were real-world data indicating improved clinician decision-making among select patients who underwent Cxbladder testing.

Continuous Glucose Monitoring in Adults with Type 1 Diabetes: Real-World Data from the German/Austrian Prospective Diabetes Follow-Up Registry

2020 ◽  
Vol 22 (8) ◽  
pp. 602-612
Author(s):  
Dirk Sandig ◽  
Julia Grimsmann ◽  
Christina Reinauer ◽  
Andreas Melmer ◽  
Stefan Zimny ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Continuous Glucose Monitoring ◽  
Real World ◽  
Glucose Monitoring ◽  
Real World Data ◽  
World Data

scholarly journals P335 Long-term follow-up of switching from original infliximab to infliximab biosimilar: real-world data

2019 ◽  
Vol 13 (Supplement_1) ◽  
pp. S268-S269
Author(s):  
M Guerra Veloz ◽  
M Belvis Jimenez ◽  
T Valdes Delgado ◽  
L Castro Laria ◽  
B Maldonado Pérez ◽  
...  
Keyword(s):  
Real World ◽  
Real World Data ◽  
World Data ◽  
Long Term Follow Up
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