scholarly journals Correction to: Modern management of iron overload in thalassemia major patients guided by MRI techniques: real‑world data from a long‑term cohort study

2022 ◽  
Author(s):  
Selen Bayraktaroglu ◽  
Nihal Karadas ◽  
Sebnem Onen ◽  
Deniz Yılmaz Karapinar ◽  
Yesim Aydinok
Keyword(s):  
Cohort Study ◽  
Iron Overload ◽  
Real World ◽  
Thalassemia Major ◽  
Real World Data ◽  
World Data ◽  
Modern Management

Modern management of iron overload in thalassemia major patients guided by MRI techniques: real-world data from a long-term cohort study

2022 ◽  
Author(s):  
Selen Bayraktaroglu ◽  
Nihal Karadas ◽  
Sebnem Onen ◽  
Deniz Yılmaz Karapinar ◽  
Yesim Aydinok
Keyword(s):  
Cohort Study ◽  
Iron Overload ◽  
Real World ◽  
Thalassemia Major ◽  
Real World Data ◽  
World Data ◽  
Modern Management

scholarly journals Use of real-world data to study health services utilisation and comorbidities in long-term breast cancer survivors (the SURBCAN study): study protocol for a longitudinal population-based cohort study

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e040253
Author(s):  
Anna Jansana ◽  
Isabel Del Cura ◽  
Alexandra Prados-Torres ◽  
Teresa Sanz Cuesta ◽  
Beatriz Poblador-Plou ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cohort Study ◽  
Health Services ◽  
Cancer Survivors ◽  
Real World ◽  
Breast Cancer Survivors ◽  
Population Based ◽  
Real World Data ◽  
World Data

IntroductionBreast cancer has become a chronic disease due to survival improvement and the need to monitor the side effects of treatment and the disease itself. The aim of the SURBCAN study is to describe comorbidity, healthcare services use and adherence to preventive recommendations in long-term breast cancer survivors and to compare them with those in women without this diagnosis in order to improve and adapt the care response to this group of survivors.Methods and analysisPopulation-based retrospective cohort study using real-world data from cancer registries and linked electronic medical records in five Spanish regions. Long-term breast cancer survivors diagnosed between 2000 and 2006 will be identified and matched by age and administrative health area with women without this diagnosis. Sociodemographic and clinical variables including comorbidities and variables on the use of health services between 2012 and 2016 will be obtained from databases in primary and hospital care. Health services use will be assessed through the annual number of visits to primary care professionals and to specialists and through annual imaging and laboratory tests. Factors associated with healthcare utilisation and comorbidities will be analysed using multilevel logistic regression models. Recruitment started in December 2018.Ethics and disseminationThis study was approved by the Ethics Committee of Parc de Salut Mar. The results of the study will be published in a peer-reviewed journal and will be presented at national and international scientific conferences and at patient associations.Trial registration numberThis protocol is registered in Clinical Trials.gov (identifier: NCT03846999).

878-P: Real-World Data from U.S. Patients Using a Long-Term Implantable Continuous Glucose Monitoring (CGM) System: Age Effect on Glycemic Control

Diabetes ◽  
2020 ◽  
Vol 69 (Supplement 1) ◽  
pp. 878-P
Author(s):  
KATHERINE TWEDEN ◽  
SAMANWOY GHOSH-DASTIDAR ◽  
ANDREW D. DEHENNIS ◽  
FRANCINE KAUFMAN
Keyword(s):  
Glycemic Control ◽  
Continuous Glucose Monitoring ◽  
Real World ◽  
Glucose Monitoring ◽  
Age Effect ◽  
Real World Data ◽  
World Data

Long-term outcome of minimally invasive mitral valve annuloplasty in disproportionate mitral regurgitation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Albano ◽  
S Nagumo ◽  
M Vanderheyden ◽  
J Bartunek ◽  
C Collet ◽  
...  
Keyword(s):  
Mitral Valve ◽  
Mitral Regurgitation ◽  
Minimally Invasive ◽  
Real World ◽  
Independent Predictor ◽  
Real World Data ◽  
Long Term Outcome ◽  
World Data ◽  
Mitral Valve Annuloplasty

Abstract Background Hypothetical concept of disproportionate secondary mitral regurgitation (SMR) has been recently introduced to facilitate patient's selection for mitral valve intervention. However, real world data validating this concept are unavailable. Purpose To investigate long-term effects of minimally invasive mitral valve annuloplasty (MVA) in patients with disproportionate (dSMR) versus proportionate SMR. Methods The study population consisted of 44 consecutive patients (age 67±9,5 years; 64% males) on guidelines-directed therapy with advanced heart failure (HF), reduced LV ejection fraction (EF) (32±9,7%) and SMR undergoing isolated mini-invasive MVA. Patients with organic mitral regurgitation or concomitant myocardial revascularization were excluded. To assess SMR disproportionality, the PISA-derived effective regurgitant orifice area (EROA) and regurgitant volume (RV) were compared to the estimated EROA and RV by using Gorlin formula and pooled real world data. Results According to EROA, a total of 20 (46%) and 24 (54%) patients, respectively, had dSMR and proportionate SMR (pSMR). According to RV, a total of 17 (39%) had dSMR and 27 (61%) had pSMR. Patients with dSMR showed significantly lower prevalence of male gender and higher prevalence of diabetes mellitus than patients with pSMR (p<0,001). Moreover, we observed smaller LV end-diastolic volume, larger EROA and RV (both p<0,01) and higher LV EF (p=0,02) in the dSMR versus the pSMR group. Other baseline characteristics were similar. During median follow up of 4.39 y (IQR 2,2–9,96y), a total of 25 (56%) patients died from any cause while 21 (47%) individuals were readmitted for worsening HF. Patients with dSMR versus pSMR according to both EROA and RV showed significantly lower rate of HF readmissions (both p<0.05) (Figure 1, 2). In Cox regression analysis combining clinical and imaging parameters, dSMR was the only independent predictor of HF readmissions (HR 0.20, 95% CI 0.07–0.60, p=0.004). In contrast, mortality was similar between dSMR and pSMR (NS) with age as the only independent predictor (HR 1,10; 95% CI 1,03–1,18, p=0,003). Conclusions Minimally invasive MVA is associated with significant reduction of HF readmissions in patients with dSMR versus pSMR while the mortality is similar. This suggests the importance of other parameters, i.e. age and degree of LV remodeling, to guide clinical management in SMR. Funding Acknowledgement Type of funding source: None

Fr518 LONG-TERM SAFETY OF TOFACITINIB: REAL WORLD DATA FROM A TERTIARY CENTER

2021 ◽  
Vol 160 (6) ◽  
pp. S-342-S-343
Author(s):  
Nathaniel A. Cohen ◽  
Joshua M. Steinberg ◽  
Alexa Silfen ◽  
Cindy Traboulsi ◽  
Jorie Singer ◽  
...  
Keyword(s):  
Real World ◽  
Real World Data ◽  
World Data ◽  
Tertiary Center

scholarly journals LDL-cholesterol change and goal attainment following statin intensity titration among Asians in primary care: a retrospective cohort study

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Hao Sen Andrew Fang ◽  
Qiao Gao ◽  
Mong Li Lee ◽  
Wynne Hsu ◽  
Ngiap Chuan Tan
Keyword(s):  
Primary Care ◽  
Clinical Trials ◽  
Cohort Study ◽  
Real World ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Goal Attainment ◽  
Real World Data ◽  
World Data ◽  
Asian Patients

Abstract Background Clinical trials have demonstrated that either initiating or up-titrating a statin dose substantially reduce Low-Density Lipoprotein-Cholesterol (LDL-C) levels. However, statin adherence in actual practice tends to be suboptimal, leading to diminished effectiveness. This study aims to use real-world data to determine the effect on LDL-C levels and LDL-C goal attainment rates, when selected statins are titrated in Asian patients. Methods A retrospective cohort study over a 5-year period, from April 2014 to March 2019 was conducted on a cohort of multi-ethnic adult Asian patients with clinical diagnosis of Dyslipidaemia in a primary care clinic in Singapore. The statins were classified into low-intensity (LI), moderate-intensity (MI) and high-intensity (HI) groups according to the 2018 American College of Cardiology and American Heart Association (ACC/AHA) Blood Cholesterol Guidelines. Patients were grouped into “No statin”, “Non-titrators” and “Titrators” cohorts based on prescribing patterns. For the “Titrators” cohort, the mean percentage change in LDL-C and absolute change in LDL-C goal attainment rates were computed for each permutation of statin intensity titration. Results Among the cohort of 11,499 patients, with a total of 266,762 visits, there were 1962 pairs of LDL-C values associated with a statin titration. Initiation of LI, MI and HI statin resulted in a lowering of LDL-C by 21.6% (95%CI = 18.9–24.3%), 28.9% (95%CI = 25.0–32.7%) and 25.2% (95%CI = 12.8–37.7%) respectively. These were comparatively lower than results from clinical trials (30 to 63%). The change of LDL-C levels due to up-titration, down-titration, and discontinuation were − 12.4% to − 28.9%, + 13.2% to + 24.6%, and + 18.1% to + 32.1% respectively. The improvement in LDL-C goal attainment ranged from 26.5% to 47.1% when statin intensity was up-titrated. Conclusion In this study based on real-world data of Asian patients in primary care, it was shown that although statin titration substantially affected LDL-C levels and LDL-C goal attainment rates, the magnitude was lower than results reported from clinical trials. These results should be taken into consideration and provide further insight to clinicians when making statin adjustment recommendations in order to achieve LDL-C targets in clinical practice, particularly for Asian populations.

VP08 Real-World Data Use In Health Technology Assessments: A Comparison Of Five Health Technology Assessment Agencies

2017 ◽  
Vol 33 (S1) ◽  
pp. 149-150
Author(s):  
Amr Makady ◽  
Ard van Veelen ◽  
Anthonius de Boer ◽  
Hans Hillege ◽  
Olaf Klunger ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
Relative Effectiveness ◽  
Internal Validity ◽  
Health Technology ◽  
Real World Data ◽  
World Data ◽  
The Impact

INTRODUCTION:Reimbursement decisions are usually based on evidence from randomized controlled trials (RCT) with high internal validity but lower external validity. Real-World Data (RWD) may provide complimentary evidence for relative effectiveness assessments (REA's) and cost-effectiveness assessments (CEA's) of treatments. This study explores to which extent RWD is incorporated in REA's and CEA's of drugs used to treat metastatic melanoma (MM) by five Health Technology Assessment (HTA) agencies.METHODS:Dossiers for MM drugs published between 1 January 2011 and 31 December 2016 were retrieved for HTA agencies in five countries: the United Kingdom (NICE), Scotland (SMC), France (HAS), Germany (IQWiG) and the Netherlands (ZIN). A standardized data-extraction form was used to extract data on RWD mentioned in the assessment and its impact on appraisal (for example, positive, negative, neutral or unknown) for both REA and CEA.RESULTS:In total, fourty-nine dossiers were retrieved: NICE = 10, SMC = 13, IQWiG = 16, HAS = 8 and ZIN = 2. Nine dossiers (18.4 percent) included RWD in REA's for several parameters: to describe effectiveness (n = 5) and/or the safety (n = 2) of the drug, and/or the prevalence of MM (n = 4). CEA's were included in 25/49 dossiers (IQWiG and HAS did not perform CEA's). Of the twenty-five CEA's, twenty (80 percent) included RWD to extrapolate long-term effectiveness (n = 19), and/or identify costs associated with treatments (n = 7). When RWD was included in REA's (n = 9), its impact on the appraisal was negative (n = 4), neutral (n = 2), unknown (n = 1) or was not discussed in the appraisal (n = 2). When RWD was included in CEA's (n = 11), its impact on the appraisal varied between positive (n = 2), negative (n = 5) and unknown (n = 4).CONCLUSIONS:Generally, RWD is more often included in CEA's than REA's (80 percent versus 18.4 percent, respectively). When included, RWD was mostly used to describe the effectiveness of the drug (REA) or to predict long-term effectiveness (CEA). The impact of RWD on the appraisal varied greatly within both REA's and CEA's.

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