Randomized Controlled Trials and real life studies. Approaches and methodologies: a clinical point of view.

S Saturni, F Bellini, F Braido, P Paggiaro… - Pulmonary …, 2014 - Elsevier
Abstract Randomized Controlled Trials (RCTs) are the “gold standard” for evaluating
treatment outcomes providing information on treatments “efficacy”. They are designed to test …

Impact of real-world data on market authorization, reimbursement decision & price negotiation

AA Pulini, GM Caetano, H Clautiaux… - … Innovation & Regulatory …, 2021 - Springer
Real-world data (RWD) and real-world evidence (RWE) appear now as complementary to
traditional randomized controlled trials (RCT), that remain the gold standard of the evidence …

Cost effectiveness of support for people starting a new medication for a long-term condition through community pharmacies: an economic evaluation of the new …

RA Elliott, L Tanajewski, G Gkountouras, AJ Avery… - …, 2017 - Springer
Abstract Background The English community pharmacy New Medicine Service (NMS)
significantly increases patient adherence to medicines, compared with normal practice. We …

Projecting the COPD population and costs in England and Scotland: 2011 to 2030

S McLean, M Hoogendoorn, RT Hoogenveen… - Scientific reports, 2016 - nature.com
We aimed to estimate the prevalence, healthcare costs and number of deaths among people
with chronic obstructive pulmonary disease (COPD) in England and Scotland 2011–2030 …

Systematic review and quality appraisal of cost-effectiveness analyses of pharmacologic maintenance treatment for chronic obstructive pulmonary disease …

S van der Schans, LMA Goossens, MRS Boland… - …, 2017 - Springer
Background Worldwide, chronic obstructive pulmonary disease (COPD) is a highly prevalent
chronic lung disease with considerable clinical and socioeconomic impact. Pharmacologic …

Utilities for asthma and COPD according to category of severity: a comprehensive literature review

TR Einarson, BG Bereza, TA Nielsen… - Journal of Medical …, 2015 - Taylor & Francis
Background: Asthma and chronic obstructive pulmonary disease (COPD) are incurable
diseases that impact quality-of-life. Objective: To summarize original research articles that …

[HTML][HTML] Health and healthcare: assessing the real world data policy landscape in Europe

C Miani, E Robin, V Horvath, C Manville… - Rand health …, 2014 - pmc.ncbi.nlm.nih.gov
Real-world data (RWD) is an umbrella term for different types of data that are not collected in
conventional randomised controlled trials. RWD in the healthcare sector comes from various …

Quality-adjusted life-years gain and health status in patients with OSAS after one year of continuous positive airway pressure use

CF Rizzi, MB Ferraz, D Poyares, S Tufik - Sleep, 2014 - academic.oup.com
Abstract Study Objectives: To estimate the health utility score and quality-adjusted life-years
(QALY) index of obstructive sleep apnea syndrome (OSAS) in patients over 1 y of …

Big data and real-world data based cost-effectiveness studies and decision-making models: a systematic review and analysis

ZK Lu, X **ong, T Lee, J Wu, J Yuan… - Frontiers in …, 2021 - frontiersin.org
Background: Big data and real-world data (RWD) have been increasingly used to measure
the effectiveness and costs in cost-effectiveness analysis (CEA). However, the …

Cost-effectiveness of endobronchial valve therapy for severe emphysema: a model-based projection based on the VENT study

JB Pietzsch, A Garner, FJF Herth - Respiration, 2014 - karger.com
Background: Endobronchial valve (EBV) therapy is an innovative treatment that has been
shown to be safe and effective in selected subgroups of patients with severe emphysema …