ART Data Monitoring
Last updated: 13 November 2009
Sub-Committee on National Anonymous ART Data Monitoring
The SASREG sub-committee on national anonymous ART data monitoring is one of several sub-committees of the society established to implement the objectives of SASREG.
Aims of the sub-committee on national anonymous ART data monitoring:
To implement national anonymous ART data monitoring through voluntary participation of ART clinics.
Objectives
To build an ART data register which reports annually on the collective number and outcome of ART procedures conducted in South Africa. All data submitted voluntarily to the register by individual participating centres will be made anonymous and entered into a national data pool.
The annual report will not contain any identifying information pertaining to the data of any individual clinic/laboratory (such as annual number of cycles or pregnancy rates). All clinics/laboratories that submitted their annual data will, however, be named and acknowledged in the report.
Name of the register
The register will be known as the South African Register of Assisted Reproductive Techniques (SARA).
Benefits of national anonymous ART data monitoring
The development of a national anonymous ART data register has several benefits which include:
- Relevant data on ART coverage. An annual report of the collective number of ART cycles conducted by all participating clinics will be an important indication of availability and access to ART in South Africa. It will help to determine to what extend the need for ART treatment, which is estimated at 1500 ART cycles/million people/annum, is being met.
- Relevant data on the efficacy and safety of ART treatment. Annual outcome measures will include, among others, national mean pregnancy rate or live birth rate per oocyte aspiration or embryo transfer; age-related pregnancy rates; multiple pregnancy rates; and the occurrence of complications such as severe ovarian hyperstimulation syndrome. These outcome measures allow patients, health care funders and health care providers to evaluate the costs and benefits of ART treatment and to make comparisons with different therapeutic options. The data is also relevant to other stakeholders such as the industry and the media.
- Furthering trust and acceptance from the public into techniques that are sometimes at risk of being perceived as 'unnatural', 'dangerous', 'unregulated' or 'unpredictable'.
- The ability to determine trends over time and to react appropriately.
- Participation in the global monitoring of ART and in international comparisons relating to ART access and practice.
- Improving the quality of infertility care in South Africa. Experience has demonstrated that the implementation of national or regional ART data monitoring is associated with improved quality of ART. Moreover, individual clinics/laboratories will have an important external quality control measure against which to evaluate their own performance data.
Progress and timelines
Visits to ART clinics in South Africa have been conducted by members of SASREG and discussions about ART data monitoring have been held. Input into the process of national anonymous ART data monitoring has been invited on several occasions and we have been grateful to receive valuable feedback from many of our colleagues.
A call for retrospective data for 2009 will be made in March 2010. This call will comprise very basic data only, the details of which will be forwarded to all clinics expressing interest in participating.
We are currently awaiting the finalisation of the software programme which will allow clinics/laboratories to capture ART data prospectively from January 2010 and to submit their data at the end of a reporting cycle. The programme is being developed by experts of the Latin American Register for ART (see below: International interest and support). Clinics/laboratories are, however, free to use their own systems of data capture and to enter their data into SARA at the end of the year.
Safeguarding anonymity and data
A confidentiality contract will be signed between parties (ie reporting clinics/laboratories, SASREG and the secretariat of SASREG).
Participating clinics/laboratories will submit their annual summary data to the secretariat of SASREG where all identifying information will be removed from the data by staff of the secretariat (that is staff not involved in health care/ART). The data will be pooled, and the pooled data will be analysed and reported to all stake holders.
All data will be safeguard through appropriate security measures.
Limitations of national anonymous ART data monitoring
The success of the register is dependant on the voluntary participation of ART clinics. Limited participation will not make the register less important in any way, but it will reduce the representativeness of the annual report. We therefore hope and encourage buy-in from all ART clinics/laboratories in South Africa.
The reliability of the register depends on the reliability of data submitted by each participating centre. This in turn depends on mutual trust and respect between all parties involved. It is not the aim or purpose of the register to 'police' or be suspicious of submitted data. There is no perceivable advantage in the submission of falsified data since all data will be anonymized and pooled.
National ART data monitoring is not a substitute for sound clinical or laboratory research, although it may assist in ART-related research. Answers to the question, for example, 'What is the optimal stimulation protocol for ART?' must be derived from randomized controlled trials not from national data registries. It is likely that national anonymous data monitoring will raise more research questions than it will initially help to answer.
International interest and support
In working towards national anonymous ART data monitoring the sub-committee has received support and interest from various official bodies. We wish to acknowledge:
- The office of the Latin American Register of Assisted Reproduction (RLA) which is part of the Latin American Network of Assisted Reproduction (REDLARA). Represented by Dr Fernando Zegers-Hochschild and Ms Verónica Galdames the RLA has provided invaluable expertise and support. They generously agreed to make their software programme available to South Africa and to modify it according to our local needs. As a result we do not only have their expert input, but the advantage of a single software programme capturing data in South America, South Africa and - hopefully in the future - sub-Saharan Africa.
- The International Committee for Monitoring Assisted Reproductive Technology (ICMART), the International Federation of Fertility Societies (IFFS) and the World Health Organisation (WHO). Representatives of these organisations have shown a keen interest in the implementation of national anonymous ART data monitoring in South Africa and have provided expert advice on several occasions. Moreover, a jointly conducted meeting on the ART glossary and International Data Monitoring held in Geneva in 2008 provided a member of the SASREG sub-committee with the opportunity to develop a better understanding of the functioning of ART data registers.
Funding the project
The sub-committee is currently in the process of raising funds to initiate and sustain national anonymous data monitoring in South Africa. We trust that this project will receive the support from the industry and other stakeholders. Any support obtained will be publicly acknowledged.
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