1607-P: Real-World Evidence of the Impact of Obesity on Residual Teeth in the Japanese Population

Diabetes ◽  
2020 ◽  
Vol 69 (Supplement 1) ◽  
pp. 1607-P
Author(s):  
MAYU HAYASHI ◽  
KATSUTARO MORINO ◽  
KAYO HARADA ◽  
MIKI ISHIKAWA ◽  
ITSUKO MIYAZAWA ◽  
...  
Keyword(s):  
Real World ◽  
Japanese Population ◽  
Real World Evidence ◽  
The Impact

The impact of anti-CGRP monoclonal antibodies in resistant migraine patients: a real-world evidence observational study

2021 ◽  
Author(s):  
Marta Torres-Ferrús ◽  
Victor J. Gallardo ◽  
Alicia Alpuente ◽  
Edoardo Caronna ◽  
Eulalia Gine-Cipres ◽  
...  
Keyword(s):  
Monoclonal Antibodies ◽  
Observational Study ◽  
Real World ◽  
Real World Evidence ◽  
The Impact

scholarly journals Real-world evidence on sodium-glucose cotransporter-2 inhibitor use and risk of Fournier’s gangrene

2020 ◽  
Vol 8 (1) ◽  
pp. e000985 ◽  
Author(s):  
Jeff Yufeng Yang ◽  
Tiansheng Wang ◽  
Virginia Pate ◽  
John B Buse ◽  
Til Stürmer
Keyword(s):  
Real World ◽  
Fournier’S Gangrene ◽  
Sensitivity Analyses ◽  
Standardized Mortality Ratio ◽  
Fournier's Gangrene ◽  
Diagnosis Codes ◽  
Sodium Glucose Cotransporter ◽  
Real World Evidence ◽  
Increased Risk ◽  
The Impact

BackgroundSodium-glucose cotransporter-2 inhibitors (SGLT2i) have been associated with increased occurrence of Fournier’s gangrene (FG), a rare but serious form of necrotizing fasciitis, leading to a warning from the Food and Drug Administration. Real-world evidence on FG is needed to validate this warning.MethodsWe used data from IBM MarketScan (2013–2017) to compare the incidence of FG among adult patients who initiated either SGLT2i, a dipeptidyl peptidase-4 inhibitor (DPP4i), or any non-SGLT2i antihyperglycemic medication. FG was defined using inpatient International Classification of Diseases, Ninth Edition and Tenth Edition diagnosis codes 608.83 and N49.3, respectively, combined with procedure codes for debridement, surgery, or systemic antibiotics. We estimated crude incidence rates (IRs) using Poisson regression, and crude and adjusted HRs (aHR) and 95% CIs using standardized mortality ratio-weighted Cox proportional hazards models. Sensitivity analyses examined the impact of alternative outcome definitions.ResultsWe identified 211 671 initiators of SGLT2i (n=93 197) and DPP4i (n=118 474), and 305 329 initiators of SGLT2i (n=32 868) and non-SGLT2i (n=272 461). Crude FG IR ranged from 3.2 to 3.8 cases per 100 000 person-years during a median follow-up of 0.51–0.58 years. Compared with DPP4i, SGLT2i initiation was not associated with increased risk of FG for any outcome definition, with aHR estimates ranging from 0.25 (0.04–1.74) to 1.14 (0.86–1.51). In the non-SGLT2i comparison, we observed an increased risk of FG for SGLT2i initiators when using FG diagnosis codes alone, using all diagnosis settings (aHR 1.80; 0.53–6.11) and inpatient diagnoses only (aHR 4.58; 0.99–21.21).ConclusionsNo evidence of increased risk of FG associated with SGLT2i was observed compared with DPP4i, arguably the most relevant clinical comparison. However, uncertainty remains based on potentially higher risk in the broader comparison with all non-SGLT2i antihyperglycemic agents and the rarity of FG.Trial registration numberEUPAS Register Number 30018.

scholarly journals P1.16-07 Real World Evidence of the Impact of Immunotherapy in Patients with Advanced Lung Cancer

2019 ◽  
Vol 14 (10) ◽  
pp. S588
Author(s):  
C. Pettengell ◽  
J. Law ◽  
L. Le ◽  
M. Sung ◽  
S. Lau ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Real World ◽  
Advanced Lung Cancer ◽  
Real World Evidence ◽  
The Impact

scholarly journals N15 A ‘real-world’ observational multi-centre study comparing the side effects and patient acceptability of budesonide MMX with prednisolone in patients with mild to moderate ulcerative colitis

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S664-S665
Author(s):  
J Kearns ◽  
L Scullion ◽  
C Masterson ◽  
N Kennedy ◽  
C Butcher
Keyword(s):  
Ulcerative Colitis ◽  
Side Effects ◽  
Real World ◽  
Additional Data ◽  
Patient Acceptability ◽  
Multi Centre Study ◽  
Real World Evidence ◽  
Randomised Controlled ◽  
The Impact

Abstract Background Budesonide MMX is indicated for the induction of remission in mild to moderate Ulcerative Colitis (UC) patients when 5-ASA treatment is not sufficient. Unlike traditional first-generation glucocorticoid steroids such as prednisolone, budesonide MMX has demonstrated a robust safety profile, comparable to placebo in several randomised controlled trials1,2,3. There is however limited real-world evidence to substantiate this safety claim in clinical practice. The aim of this observational analysis is to evaluate the tolerability and ease of administration of budesonide MMX in the real-world setting using prednisolone as a benchmark. Methods Patients receiving treatment for mild to moderate UC were identified in 3 treatment centres between April and October 2019. After providing privacy and data consent, patients completed a detailed nurse-led questionnaire regarding their experiences with prednisolone treatment. Following 6 weeks of therapy with budesonide MMX, patients were sent a follow-up questionnaire. Data from both the initial and subsequent questionnaires were entered by the nurse into a database for assimilation and analysis. Results Twenty-eight patients completed initial and follow-up questionnaires. Of these, 78.6% (n = 22) had experienced ≥1 prednisolone-related side effects. In comparison, following treatment with budesonide MMX, 21.4% (n = 6) reported ≥1 side effects. Instances of these side effects are shown in Figure 1. 46.4% of patients (n = 13) reported the impact of prednisolone-related side effects on daily life as moderate or severe vs. 7.1% (n = 2) following treatment with budesonide MMX. By week 2 of treatment with budesonide MMX, rectal bleeding was resolved in 32.1% of patients (n = 9) and stool frequency in 35.7% (n = 10). 93.1% (n = 27) found the instructions to take budesonide MMX given by the health care professional very easy to understand and of those expressing a preference, 71.1% of patients (n = 19) would take budesonide MMX again if prescribed. Additional data will be presented. Conclusion Data from this ‘real-world’ observational study appear to support the safely profile of budesonide MMX reported in clinical trials. The incidence of patients who experienced > 1 side-effect was nearly 4 times lower for budesonide vs. prednisolone. In addition, budesonide MMX therapy was acceptable to the majority of patients and accompanying instructions easy to understand. Additional data will be presented. References

scholarly journals The impact of HPV multi-cohort vaccination: Real-world evidence of faster control of HPV-related morbidity

Vaccine ◽  
2020 ◽  
Vol 38 (6) ◽  
pp. 1345-1351 ◽  
Author(s):  
Madleen Orumaa ◽  
Susanne K. Kjaer ◽  
Christian Dehlendorff ◽  
Christian Munk ◽  
Anne Olaug Olsen ◽  
...  
Keyword(s):  
Real World ◽  
Real World Evidence ◽  
The Impact

Colina 111 PET results in a nonmetastatic castration-resistant cancer (nmCRPC) in population that is negative by conventional imaging: True incidence from real-world evidence data.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e17522-e17522
Author(s):  
Martin Pitzzu ◽  
Luciana Gennari ◽  
Norberto Olguin ◽  
Gustavo Jankilevich
Keyword(s):  
Prostate Cancer ◽  
Real World ◽  
Drop Out ◽  
Conventional Imaging ◽  
Castration Resistant Prostate Cancer ◽  
True Incidence ◽  
Castration Resistant ◽  
Real World Evidence ◽  
Metastatic Setting ◽  
The Impact

e17522 Background: Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC) is characterized by a rising prostate-specifing antigen (PSA) level, castrate testosterone levels,and no evidence of distant metastases by conventional bone scan and croos-sectional image of the chest,abdomen and pelvis. SPARTAN and PROSPER trials recently demonstrated metastasis free survival in patients with nmCPRC treated with apalutamide with androgen blockade therapy and enzalutamide respectively, Real incidence of nmCPRC in latinoamerican population is unknown. Therefore, patients with negative conventional imaging could be metastatic with PET use, fall the percentage of non metastatic setting PET Colina demonstrated improved sensitivity and specificity used for biochemically recurrent hormone – sensitive patients and staging advanced disease. Colina – PET performance in nmCPRC remain largely unknown and requires evaluation. In this study we examined the incidence of nmCPRC in an Argentinian population by conventional imaging studies and the impact of use of Colina Pet. Methods: Overall 300 patients from public and private insitutions were assessed. Real World Evidence Prostate cancer database were retrospectively screened for records of patients with nmCPRC. Results: Three hundred medical records of consecutive patients with prostate cancer were assessed. All patients were evaluated by multidisciplinary team Localized disease 214 patients and metastatic Prostate Cancer Castration Sensitive 86 patients. With a median a six years of median follow up, 43 patients developed Prostate Cancer Castration Resistant. Six patients showed nmCPRC criteria, in all of them Colina Pet was indicated. After PET colina 5 cases were positives and only one patient were negative. Conclusions: The incidence or nmCPRC is 0,02% in argentine cohort and drop out to 0,003% with PET use. Colina-PET detected loco-regional of M1 disease in nearly all patients with CPRC and no detectable metastasis by conventional imaging. Further epidemiologic with real world evidence data studies with cost-efective evaluations should be launched to put in context the rol of PET in this setting.

OP29 Building A Global, Public Repository Of Patient Experience Data

2019 ◽  
Vol 35 (S1) ◽  
pp. 7-7
Author(s):  
Catherine Holliday
Keyword(s):  
Health Technology Assessment ◽  
Patient Experience ◽  
Technology Assessment ◽  
Real World ◽  
Muscular Atrophy ◽  
Health Technology ◽  
Structured Interview ◽  
Real World Evidence ◽  
Qualitative Component ◽  
The Impact

IntroductionThe Patient Experience, Expectations and Knowledge (PEEK) protocol was developed so that a holistic, comprehensive, independent, proactive and systematic approach could be taken to inform decisions made in the context of health technology assessment and other parts of the health sector. Each PEEK study is made publicly available which over time will result in a global repository of patient experience data.MethodsThe PEEK protocol is a single protocol that can be implemented across disease areas and includes a quantitative and qualitative component. The quantitative component is based on a series of validated tools that provide baseline health and demographic data for the study population. The qualitative component is the result of two years of protocol testing to develop a structured interview that solicits comprehensive and holistic patient experience data, and provides participants with the opportunity to provide advice on their future expectations.ResultsPEEK studies in breast cancer, bladder cancer, lung cancer, spinal muscular atrophy, atopic dermatitis, chronic kidney disease, chronic heart failure and mitochondrial disease have been completed in the Australian context (www.cc-dr.org/peek). Holistic patient experience themes are presented commencing with symptoms and diagnosis experience, through to communication, information, treatments experienced and quality of life. Information is also available in relation to participant's expectations of future treatment, care, information and communication. The result is a freely available repository of patient experience data that anyone in the sector can access to complement clinical and economic evidence.ConclusionsThe process of providing patient feedback and real-world evidence in the context of health technology assessment is often ad-hoc. The lack of consistency means that it has been difficult to assess the impact of patient engagement and feedback in the context of health technology assessment. The PEEK protocol and program is an example of a systematic, independent and holistic approach to patient experience and real-world evidence data collection that provides the sector with an opportunity to proactively engage the community in decisions that are made about treatment, care and support.

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