Information for Patients
Linking and analysing data in the quest for better cardiac health
Professor David Playford
Professor Geoff Strange
Professor David Celermajer
Professor Greg Scalia
Professor Tom Marwick
Associate Professor David Prior
Dr Majo Joseph
Dr Marcus Ilton
Professor Simon Stewart
Professor Jim Codde
Information for participants
To find out more about your participation in the NEDA Project, please read the following information. If you choose to not participate in the research, please complete the Opt Out Form located here Opt Out Form.
1. What is NEDA?
The National Echo Database Australia (NEDA) is a database collecting health information from adults who have undergone an echocardiogram at a participating hospital throughout Australia. The information in the NEDA database will be used to gain a better understanding of heart measurements and health outcomes.
NEDA is run by Coordinating Principal Investigators Professor David Playford & Professor Geoff Strange.
2. How is NEDA funded?
The study is funded from multiple sources, including pharmaceutical companies (GlaxoSmithKline, Actelion and Bayer) under an ‘unrestricted grant’ scheme. No individual data is shared with these funding sources. The funding is administered through NEDA Limited.
3. What is the purpose of this database?
The information collected on the NEDA database will be used for research purposes and aims to improve our understanding of how changes in heart measurements that may affect health and outcomes over time. The information within the database will help create new ways of detecting heart disease earlier, more effectively and accurately, and with higher quality. NEDA will be collecting data from adults who have an echocardiogram at participating hospitals in Australia.
4. What does participation involve?
If you are happy to have your health information included in the NEDA database, you do not have to do anything. Measurement information from your echocardiogram will be entered into NEDA which is a secure database. None of your heart images will be included in the database. The NEDA database will also collect information such as your name, date of birth, gender, body measurements, diagnosis and location of your treating institution. No other health information from your medical record will be collected. The limited information we collect will be linked to the National Death Index (NDI) and state and territory-based hospital morbidity datasets (admission and emergency data) periodically. Any research being conducted using NEDA will be performed using de-identified information that cannot be re-identified. De-identified data (from which you can never be identified) may also be used by authorised external national organisations for development of new systems for early diagnosis, such as artificial intelligence.
The NEDA program involves the following:
Formation of large echo database by combining data from each participant and multiple different locations around Australia, together into one repository of data.
Linkage with additional data sources, including the Australian Institute of Health and Welfare (AIHW) mortality database (NDI) and state and territory-based hospitalisation databases. Future linkage to other national databases including the Pharmaceutical Benefits Scheme (PBS) and Medicare Benefits Schedule (MBS) databases is also envisaged.
Use of the de-identified NEDA database to understand the risks associated with conditions identified by echocardiography, such as pulmonary hypertension, heart failure and heart valve disease.
Sharing of the de-identified NEDA database with approved researchers both locally and internationally, but only if ethical approval is granted first.
Communication of the results of the research through publications, guidelines and other methods to improve the quality of health care.
Participating in the NEDA Study will not require you to have any additional procedures or tests. There are no costs associated with participating in the NEDA study, nor will you be paid.
5. Do I have to take part in this program?
Participation in this database is voluntary. If you decide you do not want to take part, you do not have to and you can choose to “opt out”. You will be automatically included in the NEDA database, unless you decide to opt out within two (2) weeks of your heart scan (ECHO).
If you decide to take part and later change your mind, you are free to withdraw from the NEDA study at any stage and your information will be removed from the database and not used for future analysis.
If you would prefer not to participate in the study, you will need to tell us by entering your details at www.neda.net.au/optout. If we do not hear from you within two weeks, we will assume that you are happy for us to collect your information.
Your decision to take part or not to take part, or withdraw, will not affect your routine health care or your relationship with your heart doctor or your care at your treating hospital in any way.
6. What are the possible benefits of taking part?
While we intend that the information collected in the National Echo Database Australia will be used for research purposes to furthers medical knowledge and may improve the measurement of health outcomes in the future, it will not be of direct benefit to you.
7. What are the possible risks of taking part?
Your name and date of birth will only be used to link with outcome information with the Australian Institute of Health and Welfare mortality database (NDI) and state and territory-based hospital morbidity datasets (admission and emergency data), under strict privacy security conditions. The risk of a security breach is extremely small. All analysis is performed on a de-identified database that cannot be re-identified.
8. What will happen to information about me?
Information collected about you for the NEDA study that can identify you will remain confidential and will be permanently stored in a secure password protected online database on a secure server. Once the information is entered into the database, it will be given a unique identification number. This unique identification code will be used to link the information to your name and date of birth. De-identified information will be used for research purposes only and will be shared with local and international collaborators however ethical approval will be sought prior. You will not be identified in any reports or publications. The database is managed by Extential Solutions Pty Ltd with Azure servers located in Sydney NSW, and only the authorised researchers and database engineers involved with this project can have access to this information. As this is an ongoing study, data will be kept in a secure environment as long as the NEDA study exists. If the NEDA study ceases to exist, the information stored in the database will be destroyed in a secure manner.
9. Commercial Interest
NEDA may obtain funding and in-kind support from a variety of sources including device, pharmaceutical and technology companies. In order to execute some of the technical aspects of our research, de-identified data may be shared with our partners. However, your identity will never be shared with any commercial party. Any sharing of de-identified data uses secure technology involving encryption and password protection. NEDA researchers do not have a financial interest in any of these commercial companies. Among NEDA’s important objectives is the development of new technology to improve cardiac diagnosis. These may have future commercial implications, but since NEDA is a not-for-profit public research company, they will not directly benefit NEDA researchers.
10. Further Information and who can I contact?
If you would like to know more at any stage, please feel free to contact firstname.lastname@example.org
11. Ethics Approval and Complaints
This study has been approved by the Ethics Review Committee (RPAH Zone) of the Sydney Local Health District. Any person with concerns or complaints about the conduct of this study should contact the Executive Officer on 02 9515 6766 and quote protocol number X15-0387.