scholarly journals Registers as the basis for data collection and evidence building

2021 ◽  
Vol 1 (1) ◽  
pp. 10-15
Author(s):  
A. V. Ivanov
Keyword(s):  
Clinical Practice ◽  
Data Collection ◽  
Medical Practice ◽  
Real World ◽  
Medical Science ◽  
Real World Data ◽  
Constant Increase ◽  
Medical Technologies ◽  
Clinical Registries ◽  
Real Clinical Practice

The development of medical science requires a constant increase in the effectiveness and safety of treatment. Collection of real-world data (RWD) is one way of solving these problems. Clinical registries are one of the most important parts of this process. Clinical registries allow collecting data on the use of medical technologies and monitoring the results of therapy in real clinical practice. The introduction of patient registers and the collection of RWD data into widespread medical practice can help to optimize costs in the treatment of high-cost diseases and to better plan the budget.

Information technology in the evaluation of RWD / RWE (Real-World Data / Real-World Evidence)

2021 ◽  
Author(s):  
OV Zhukova ◽  
AL Khokholov
Keyword(s):  
Health Care ◽  
Information Technology ◽  
Clinical Practice ◽  
Clinical Efficacy ◽  
Real World ◽  
Information Technologies ◽  
Real World Data ◽  
Real World Evidence ◽  
Software Modules ◽  
Real Clinical Practice

The features of evaluating data from real clinical practice are discussed. Approaches to material processing for decision support in medicine and health care are also given. The development of standardized methods of analysis with the possibility of obtaining a unified indicator for assessing data from routine clinical practice, combined with the development of information technology is the direction of development of the concept of result-oriented health care. The classification of information technologies used in medicine and public health is presented. The main characteristics and functioning features of the developed software modules for automated data evaluation of real clinical practice are presented: a program for the distribution of drugs on the levels of clinical efficacy, a program to assess the effectiveness of therapy for the specified period; a program to determine the interval of clinical efficacy of drugs.

scholarly journals Insulin doses requirements in patients with type 1 diabetes using glargine U300 or degludec in routine clinical practice

2021 ◽  
pp. jim-2020-001633
Author(s):  
Florentino Carral San Laureano ◽  
Mariana Tomé Fernández-Ladreda ◽  
Ana Isabel Jiménez Millán ◽  
Concepción García Calzado ◽  
María del Carmen Ayala Ortega
Keyword(s):  
Type 1 Diabetes ◽  
Clinical Practice ◽  
Retrospective Study ◽  
Real World ◽  
Glycosylated Hemoglobin ◽  
Routine Clinical Practice ◽  
Insulin Analogs ◽  
Total P ◽  
Real Clinical Practice

There are not many real-world studies evaluating daily insulin doses requirements (DIDR) in patients with type 1 diabetes (T1D) using second-generation basal insulin analogs, and such comparison is necessary. The aim of this study was to compare DIDR in individuals with T1D using glargine 300 UI/mL (IGlar-300) or degludec (IDeg) in real clinical practice. An observational, retrospective study was designed in 412 patients with T1D (males: 52%; median age 37.0±13.4 years, diabetes duration: 18.7±12.3 years) using IDeg and IGla-300 ≥6 months to compare DIDR between groups. Patients using IGla-300 (n=187) were more frequently males (59% vs 45.8%; p=0.004) and had lower glycosylated hemoglobin (HbA1c) (7.6±1.2 vs 8.1%±1.5%; p<0.001) than patients using IDeg (n=225). Total (0.77±0.36 unit/kg/day), basal (0.43±0.20 unit/kg/day) and prandial (0.33±0.23 unit/kg/day) DIDR were similar in IGla-300 and IDeg groups. Patients with HbA1c ≤7% (n=113) used significantly lower basal (p=0.045) and total (p=0.024) DIDR, but not prandial insulin (p=0.241), than patients with HbA1c between 7.1% and 8% and >8%. Patients using IGla-300 and IDeg used similar basal, prandial and total DIDR regardless of metabolic control subgroup. No difference in basal, prandial and total DIDR was observed between patients with T1D using IGla-300 or IDeg during at least 6 months in routine clinical practice.

scholarly journals Valuing new medicines in the early 21:st century

2017 ◽  
Vol 5 (1) ◽  
pp. 7-22
Author(s):  
Katarina Steen Carlsson ◽  
Bengt Jönsson
Keyword(s):  
Health Care ◽  
Clinical Practice ◽  
Real World ◽  
Patent Protection ◽  
New Technologies ◽  
New Technology ◽  
Treatment Strategies ◽  
Real World Data ◽  
Study Results ◽  
Pricing And Reimbursement

What is the actual value of new medicines? The answer to this question is the key to rational use of new technologies in health care and for design of appropriate incentives for innovation. In this paper we present methods, data and study results for valuing new medical technologies in a life cycle perspective, relevant for development of a new approach to contract and payment for innovation that can replace present systems for pricing and reimbursement.   Focus is on value in clinical practice, and on the data needs and methods needed for the development of outcome-based payment systems that balances risks and rewards for innovation in health care. We provide an overview of studies from the Swedish context on the value of new medicines introduced in the treatment of diabetes, cancer, cardiovascular disease and rheumatoid arthritis. These studies using national health data and quality registers emphasise the importance of continuing efforts to collect relevant data for assessment of value after a medicine reaches the market and starts to be used in clinical practice. It is only when medicines are used in clinical practice that the benefits for real-world patient populations can be identified, measured and valued. Analyses of real-world data will also assist further development and tailoring of treatment strategies to optimize the value of the new technology. While an effective patent system rewards innovation for a limited period of time, many innovations may continue to provide value to society long after patent protection, and these values must be included in the assessment of value of innovation.

Defensive Medicine

2021 ◽  
pp. 99-124
Author(s):  
Michael J. Saks ◽  
Stephan Landsman
Keyword(s):  
Medical Practice ◽  
Real World ◽  
Healthcare Providers ◽  
Defensive Medicine ◽  
Self Report ◽  
Healthcare Industry ◽  
Clinical Scenario ◽  
Real World Data ◽  
Considerable Uncertainty ◽  
Legal Response

“Defensive Medicine: A Response to the Legal Response?” discusses the origins, meaning, purposes, and uncertain existence of defensive medicine. The concept has been most useful for those promoting changes in the law to economically benefit the healthcare industry. In the span of several decades, healthcare providers reversed their stance on whether or not they practice defensively. Why would providers commit defensive medicine? Why would they admit to practices that are universally seen as unethical, illegal (fraud), and unsound medical practice? Different types of empirical research have tried to determine whether defensive medicine occurs and, if so, its extent, cost, and effects on patients: physician self-report surveys, clinical scenario surveys, and multivariate analyses of real-world data. The chapter explores the possibility that defensive practices mostly occur in those situations where considerable uncertainty about diagnosis exists and the risk of serious harm is great if the patient is not treated correctly.

Real-World Data, Clinical Practice So Far

2021 ◽  
pp. 151-166
Author(s):  
Eleonora De Matteis ◽  
Raffaele Ornello ◽  
Simona Sacco
Keyword(s):  
Clinical Practice ◽  
Real World ◽  
Real World Data ◽  
World Data

Use of Real-World Data for advancing clinical practice

2020 ◽  
Vol 19 (s) ◽  
pp. 1-1
Author(s):  
K. Taraldsen ◽  
S. Mellone
Keyword(s):  
Clinical Practice ◽  
Real World ◽  
Real World Data ◽  
World Data

Glucose Tolerance in Patients with Cystic Fibrosis – Results from the German Cystic Fibrosis Registry

2020 ◽  
Vol 232 (04) ◽  
pp. 210-216
Author(s):  
Nicole Prinz ◽  
Julia Wosniok ◽  
Doris Staab ◽  
Manfred Ballmann ◽  
Christian Dopfer ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Glucose Tolerance ◽  
Real World ◽  
Normal Glucose Tolerance ◽  
Oral Glucose ◽  
Real World Data ◽  
Clinical Registries ◽  
Normal Glucose ◽  
Multivariable Regression ◽  
Adjusted Model

Abstract Background Oral glucose tolerance (OGT) deteriorates progressively in cystic fibrosis (CF). Clinical registries provide a unique basis to study real-world data. Patients & methods OGT tests (OGTTs) documented in the German CF-registry in 2016 were classified according WHO, modified by ADA: normal glucose tolerance (NGT), indeterminate glycaemia (INDET), impaired fasting glucose (IFG), impaired glucose tolerance (IGT), IFG+IGT, diabetes mellitus (DM). To study the association with lung function, multivariable regression adjusted for age, sex, and CFTR mutation was performed. Results Overall, OGTT screening was done in 35% of CF patients ≧10 years. Of the 996 patients (46.4% females; median age (IQR): 19 (14–27) years) with evaluable OGTTs, 56.2% had either NGT or INDET, whereas 34% had a pre-diabetic OGTT (IFG; IGT; IFG+IGT) and 9.8% a diabetic OGTT. 7 patients had glucose tolerance abnormalities <10 years. DM was more common in females or patients with F508del homozygote mutation, whereas IFG was more frequent in males (all p<0.05). Nearly 75% of patients after transplantation and about half with enteral/parental nutrition and/or steroid use had either a pre-diabetic or diabetic glucose tolerance. In the adjusted model, age (p<0.001) and OGTT category (p=0.013) had both a significant impact on %FEV1. Conclusion Our data of the German CF-registry highlights incidence of glucose tolerance abnormalities in second decade of life in CF patients. However, it also underlines the need for improvement of the documentation and/or performance of OGTT screening in real-world CF care.

scholarly journals Comparison of Cycling Behavior between Keyboard-Controlled and Instrumented Bicycle Experiments in Virtual Reality

2020 ◽  
Vol 2674 (7) ◽  
pp. 244-257
Author(s):  
Martyna Bogacz ◽  
Stephane Hess ◽  
Chiara Calastri ◽  
Charisma F. Choudhury ◽  
Alexander Erath ◽  
...  
Keyword(s):  
Virtual Reality ◽  
Experimental Design ◽  
Data Collection ◽  
Real World ◽  
Head Movements ◽  
Behavioral Data ◽  
Experimental Setup ◽  
Real World Data ◽  
World Data ◽  
Cycling Behavior

The use of virtual reality (VR) in transport research offers the opportunity to collect behavioral data in a controlled dynamic setting. VR settings are useful in the context of hypothetical situations in which real-world data does not exist or in situations which involve risk and safety issues making real-world data collection infeasible. Nevertheless, VR studies can contribute to transport-related research only if the behavior elicited in a virtual environment closely resembles real-world behavior. Importantly, as VR is a relatively new research tool, the best-practice with regards to the experimental design is still to be established. In this paper, we contribute to a better understanding of the implications of the choice of the experimental setup by comparing cycling behavior in VR between two groups of participants in similar immersive scenarios, the first group controlling the maneuvers using a keyboard and the other group riding an instrumented bicycle. We critically compare the speed, acceleration, braking and head movements of the participants in the two experiments. We also collect electroencephalography (EEG) data to compare the alpha wave amplitudes and assess the engagement levels of participants in the two settings. The results demonstrate the ability of VR to elicit behavioral patterns in line with those observed in the real-world and indicate the importance of the experimental design in a VR environment beyond the choice of audio-visual stimuli. The findings will be useful for researchers in designing the experimental setup of VR for behavioral data collection.

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