scholarly journals Generating Real-World Evidence on the Quality Use, Benefits and Safety of Medicines in Australia: History, Challenges and a Roadmap for the Future

2021 ◽  
Vol 18 (24) ◽  
pp. 13345
Author(s):  
Sallie-Anne Pearson ◽  
Nicole Pratt ◽  
Juliana de Oliveira de Oliveira Costa ◽  
Helga Zoega ◽  
Tracey-Lea Laba ◽  
...  
Keyword(s):  
Real World ◽  
Linked Data ◽  
Inappropriate Prescribing ◽  
Data Access ◽  
Well Being ◽  
Current Data ◽  
Data Sources ◽  
Safety Research ◽  
Real World Evidence ◽  
Evidence Generation

Australia spends more than $20 billion annually on medicines, delivering significant health benefits for the population. However, inappropriate prescribing and medicine use also result in harm to individuals and populations, and waste of precious health resources. Medication data linked with other routine collections enable evidence generation in pharmacoepidemiology; the science of quantifying the use, effectiveness and safety of medicines in real-world clinical practice. This review details the history of medicines policy and data access in Australia, the strengths of existing data sources, and the infrastructure and governance enabling and impeding evidence generation in the field. Currently, substantial gaps persist with respect to cohesive, contemporary linked data sources supporting quality use of medicines, effectiveness and safety research; exemplified by Australia’s limited capacity to contribute to the global effort in real-world studies of vaccine and disease-modifying treatments for COVID-19. We propose a roadmap to bolster the discipline, and population health more broadly, underpinned by a distinct capability governing and streamlining access to linked data assets for accredited researchers. Robust real-world evidence generation requires current data roadblocks to be remedied as a matter of urgency to deliver efficient and equitable health care and improve the health and well-being of all Australians.

scholarly journals Tools and Methods for Real-World Evidence Generation

2019 ◽  
Vol 45 (2) ◽  
pp. 275-289
Author(s):  
Jeffrey R. Curtis ◽  
P. Jeff Foster ◽  
Kenneth G. Saag
Keyword(s):  
Real World ◽  
Real World Evidence ◽  
Evidence Generation ◽  
Tools And Methods

OP170 Regulatory And Health Technology Assessment Considerations In Alzheimer's Disease

2018 ◽  
Vol 34 (S1) ◽  
pp. 61-62
Author(s):  
Jacoline Bouvy ◽  
Pall Jonsson
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
Data Access ◽  
Health Technology ◽  
Advisory Group ◽  
Real World Evidence ◽  
Disease Modifying

Introduction:There has been a move towards the development of disease-modifying agents in Alzheimer's disease (AD) and it is likely that early disease-modifying treatments will initially be offered to people who have positive AD markers and mild cognitive impairment (MCI). Consequently, disease-modifying drugs will have distinctive features as compared to currently licensed symptomatic treatments, which makes the implications of these new agents for regulatory and health technology assessment (HTA) processes unclear.Methods:The ROADMAP (Real-world Outcomes across the AD spectrum for better care: Multi-modal data Access Platform) project provides the foundation for a European data platform for real-world evidence in AD, and established an expert advisory group (EXAG) consisting of regulatory and HTA experts. This presentation will summarize the key lessons from the first year of ROADMAP's EXAG and identifies the next steps that are required to prepare Europe's healthcare systems for a disease-modifying drug.Results:The EXAG identified a need for: (i) establishing the rationale for the selection of priority outcomes in pre-clinical AD and MCI; (ii) establishing accepted outcomes for defining prevention of AD or delayed AD onset; (iii) exploring modern technology that could assist in testing cognition that could easily be used in clinical practice; and (iv) establishing caregiver-relevant outcomes (e.g. quality of life, loss of income, carer time) that are important to capture; and found that not all evidence to support modelling assumptions can be generated through RCTs, making the case for using real-world evidence.Conclusions:Many of the challenges that the EXAG identified can be solved by generating better real-world data in AD. There is a clear need to agree on the outcomes that will facilitate and inform regulatory and HTA decision-making. Once the gaps in the availability of outcomes in AD will be closed, we will be one step closer towards being ready for a disease-modifying drug.

scholarly journals Real-World Data Utility For Health Economic Modeling: An Assessment Of Current Data Sources

2015 ◽  
Vol 18 (3) ◽  
pp. A20
Author(s):  
M. Gavaghan ◽  
S. Armstrong ◽  
C. Taggart ◽  
S. Garfield
Keyword(s):  
Health Economic ◽  
Real World ◽  
Current Data ◽  
Economic Modeling ◽  
Data Sources ◽  
Real World Data ◽  
Data Utility ◽  
World Data

scholarly journals Population Data BC: Supporting population data science in British Columbia

2020 ◽  
Vol 4 (2) ◽  
Author(s):  
Tavinder Kaur Ark ◽  
Sarah Kesselring ◽  
Brent Hills ◽  
Kim McGrail
Keyword(s):  
Linked Data ◽  
Large Scale ◽  
Data Science ◽  
Data Linkage ◽  
Population Data ◽  
Cost Effective ◽  
Data Access ◽  
Well Being ◽  
Third Party ◽  
Individual Level

BackgroundPopulation Data BC (PopData) was established as a multi-university data and education resourceto support training and education, data linkage, and access to individual level, de-identified data forresearch in a wide variety of areas including human and community development and well-being. ApproachA combination of deterministic and probabilistic linkage is conducted based on the quality andavailability of identifiers for data linkage. PopData utilizes a harmonized data request and approvalprocess for data stewards and researchers to increase efficiency and ease of access to linked data.Researchers access linked data through a secure research environment (SRE) that is equipped witha wide variety of tools for analysis. The SRE also allows for ongoing management and control ofdata. PopData continues to expand its data holdings and to evolve its services as well as governanceand data access process. DiscussionPopData has provided efficient and cost-effective access to linked data sets for research. After twodecades of learning, future planned developments for the organization include, but are not limitedto, policies to facilitate programs of research, access to reusable datasets, evaluation and use of newdata linkage techniques such as privacy preserving record linkage (PPRL). ConclusionPopData continues to maintain and grow the number and type of data holdings available for research.Its existing models support a number of large-scale research projects and demonstrate the benefitsof having a third-party data linkage and provisioning center for research purposes. Building furtherconnections with existing data holders and governing bodies will be important to ensure ongoingaccess to data and changes in policy exist to facilitate access for researchers.

scholarly journals NEPS Starting Cohort 6 survey data linked to administrative data of the IAB (NEPS-SC6-ADIAB)

2018 ◽  
Vol 3 (2) ◽  
Author(s):  
Nadine Bachbauer
Keyword(s):  
Survey Data ◽  
Administrative Data ◽  
Linked Data ◽  
Panel Study ◽  
Data Access ◽  
Data Sources ◽  
Employment Agency ◽  
Educational Trajectories ◽  
Analytical Potential ◽  
Site Access

BackgroundNEPS-SC6-ADIAB is a new linked data product containing survey data of Starting Cohort 6 of the German National Educational Panel Study (NEPS) and administrative employment data from the Institute for Employment Research (IAB), the research institute of the Federal Employment Agency. NEPS is provided by the Leibniz Institute for Educational Trajectories (LIfBi). Starting Cohort 6 of this panel survey includes adults in their professional life, the survey focuses on education in adulthood and lifelong learning. The administrative data in NEPS-SC6-ADIAB consist of comprehensive information on the employment histories. ObjectivesCombining these two data sources increases for example the information about individual employment history. Overall, the data volume is increased by the linkage between the survey data and the administrative data. MethodsA record linkage process was used to link the two data sources. The data access is free for the whole scientific community. In addition to a large number of On-site access locations within Germany, there are also international On-site access locations. Including London and Colchester. In addition a Remote Data Access is offered. ConclusionsThis data linkage project is very innovative and creates an extensive database, which results in extensive analytical potential. A short application example is made to exemplify the comprehensive analytical potential of NEPS-SC6-ADIAB. This ongoing project deals with nonresponse in survey data. The linked data has a variety of variables collected in both data sources, administratively and through the NEPS survey, allowing for comparative analyses. In this case an idea to compensate nonresponse in income data with administrative data is drawn.

scholarly journals Do Real-World Prosociality Programs Predict Greater Psychological Well-Being in Kids?

2021 ◽  
Author(s):  
Jason Douglas Edward Proulx ◽  
Julia W. Van de Vondervoort ◽  
Kiley Hamlin ◽  
John Helliwell ◽  
Lara Beth Aknin
Keyword(s):  
Real World ◽  
Care Home ◽  
Well Being ◽  
Post Intervention ◽  
Term Care ◽  
Psychological Well Being ◽  
Disadvantaged Children ◽  
Real World Evidence ◽  
Prosocial Action

Numerous laboratory studies suggest that engaging in prosocial action predicts greater psychological well-being, yet little work has examined whether kids (aged 5–12) experience these benefits in real-world community settings. In Study 1, we surveyed 24/25 students who completed their entire Grade 6 curriculum in a long-term care home alongside residents called “Elders.” We found that the meaning that kids derived from interacting with the Elders strongly predicted greater psychological well-being. In Study 2, we conducted a pre-registered field experiment with 238 kids who were randomly assigned to package essential items for disadvantaged children who were either demographically similar or dissimilar to them. Kids self-reported their happiness both pre- and post-intervention. While happiness increased from pre- to post-intervention, this change did not differ for kids who helped a similar or dissimilar recipient. These studies offer real-world evidence that engaging in prosocial action—over an afternoon or year—may enhance kids’ psychological well-being.

Sign in / Sign up

Export Citation Format

Share Document