The field of clinical fertility research has been evolving over the past couple of decades, spurred on by the revolution brought about by assisted reproduction. With the maturity that has emerged, attention is now being paid to the real need to clarify and standardize terminology and definitions. The idea is not new; within national data registries definitions have had to be devised, but there has not been international consistency. The need for consistency is most pressing in relation to the reporting of success outcomes in assisted reproduction. This matter has been raised in recent articles in Human Reproduction (Barlow, 2003; Daya, 2003
; Vail and Gardner, 2003
).
In the reporting of ART success, a difficulty is that data can be reported to meet different purposes. At one end of the spectrum there is a need to have success measures which have validity for couples seeking treatment where live birth outcomes are accepted as the most valid. At a different extreme there is the use of ART success data as an indicator of the success of an individual clinic, possibly in a commercially competitive setting. This latter situation may encourage the use of statistics that produce the most favourable numbers. In calculating 'success rates', this might be selecting statistics that maximize numerators and/or minimize denominators, both of which maximize 'success'. Journals cannot control the use of statistics by clinics in the information they provide to patients and in advertising, but Journals do have a responsibility to seek to ensure that in scientific publishing there is a meaningful and consistent use of IVF outcome data. In this issue of Human Reproduction we open a debate on the subject of how IVF/ICSI data are reported, with a paper from the Monash Group suggesting that singleton, term gestation, live birth rate per cycle initiated should be accepted as the most relevant standard of success (Min et al., 2004). We have invited comments for this debate from an international spectrum of specialists and would welcome further divergent views.
We have recently published the view from Cochrane on the importance of the live birth endpoint in clinical trials (Johnson et al., 2003) and the issue was highlighted in my editorial (Barlow, 2003
). This journal would support an agreement on the use of a consistent method of reporting assisted reproduction outcomes and success rates in papers, and we look forward to a worthwhile debate.
A further contribution comes from ICMART (International Committee for the Monitoring of ART) and WHO, concerning definitions, which resulted in the publication of a WHO meeting in which a Glossary of Definitions in ART was provided (Current practices and controversies in Assisted Reproduction, 2002). The document can be downloaded from http://www.who.int/reproductive-health/infertility/index.htm. I note that the definition of 'clinical pregnancy' differs from that used by the UK Human Fertilisation and Embryology Authority (HFEA), in that it is based on evidence of a sac whereas the HFEA definition is based on the detection of a fetal heart beat. The WHO Glossary includes ectopic pregnancy within the definition of clinical pregnancy whereas the HFEA definition does not. Achieving standardized definitions in this field and agreed most acceptable success parameters for publication will be a major step forward.
As part of the move to standardization we can look forward to the result of the work of the European Classification of Infertility Taskforce which is currently active. I am sure all will welcome the publication of a revised 2003 ESHRE/ASRM consensus on diagnostic criteria in relation to PCOS. As an indication of the importance of this development, the Consensus document is published in this issue of Human Reproduction and in the parallel issue of Fertility and Sterility (The Rotterdam ESHRE/ASRM sponsored PCOS consensus workshop group, 2004a; The Rotterdam ESHRE/ASRM sponsored PCOS consensus workshop group, 2004b
). This consensus work on definitions and strategy is essential, not only for the meaningful reporting of scientific work, but also for the planning of approaches to management. Very often in the fertility field we lack well-powered randomized controlled trials on which we might base strategy and must depend on consensus. Such consensus might be based on a national practice standpoint but internationally there can be much to learn from well constructed nationally based work. A valuable recent example is the Strategy for fertility services for survivors of childhood cancer, published by a Working Group convened by the British Fertility Society (Andersen, 2003
).
Again, as part of the move to maximize clarity, Human Reproduction has agreed to request that authors of randomized controlled trials include the International Standard Randomized Controlled Trial Number ISRCTN (or National Library Medicine NLM) number in the abstract of their paper. This number is specific to a single trial, and will make clear to readers to which trials different papers refer, when over a period of time several papers result from a single trial. By placing the number in the abstract we can ensure that the identifying number will be seen by those who access the paper as an abstract in an electronic database, as well as by those who access the full paper. Information on this system can be obtained from http://www.controlled-trials.com/
Human Reproduction seeks to serve the reproductive medicine and reproductive science community by publishing a wide range of relevant research types. In assessing the consequences of reproductive treatments, much of the evidence must derive from observational long term studies rather than from clinical trials. Thus, as well as encouraging the publication of trials, the journal seeks to encourage the publication of reproductive epidemiology. At the other extreme, our field involves biological and disease processes that are not easily studied in the human, and we would wish to encourage the publication of relevant papers on animal models and stem cell research, both areas of increasing importance in reproduction.
In order to serve this broad base of scientific work, we have appointed a broad range of Associate Editors whose specialist role is key to the success of the journal. The burden carried by an Associate Editor is significant and when we set up the process with my appointment as Editor in Chief during 2000 we agreed that Associate Editors would normally be appointed for a period of 2 years, with some extensions in the initial phase so that we would not have all Associate Editors retiring at the same time. Our concept is that individuals might make a specialist expert commitment to the journal for a period of time, knowing that the significant workload involved is not of unlimited duration. Their service and commitment is key to the work of the journal. Sadly, at the beginning of 2004 we must once again lose some of our current Associate Editors and make new appointments. This is with the hope that some will feel able to make the significant commitment to serve the journal again in the future. Their service is marked by a listing in the journal of all former Associate Editors and we thank them for their invaluable support.
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Barlow DH (2003) The design, publication and interpretation of research in Subfertility Medicine: uncomfortable issues and challenges to be faced. Hum Reprod 18,899901.
Current Practices and Controversies in Assisted Reproduction (2002) Report of a Meeting on Medical, Ethical and Social Aspects of Assisted Reproduction held at WHO, Geneva, Switzerland, 1721 September 2001. Vayena, E., Rowe, P.J. and Griffin, P.D. (eds).
Daya S (2003) Pitfalls in the design and analysis of efficacy trials in subfertility. Hum Reprod 18,10051009.
Johnson NP, Proctor M and Farquhar CM (2003) Gaps in the evidence for fertility treatment An analysis of the Cochrane Menstrual Disorders and Subfertility Group Database. Hum Reprod 18,947954.
Min JK, Breheny S, Maclachlan V and Healy DL (2004) The singleton, term gestation, live birth rate: The BESST endpoint for assisted reproduction. Hum Reprod 19, in press.
The Rotterdam ESHRE/ASRM sponsored PCOS consensus workshop group (2004a) Revised 2003 consensus on diagnostic criteria and long-term health risks related to Polycystic Ovary Syndrome (PCOS). Hum Reprod 19, in press.
The Rotterdam ESHRE/ASRM sponsored PCOS consensus workshop group (2004b) Revised 2003 consensus on diagnostic criteria and long-term health risks related to Polycystic Ovary Syndrome (PCOS). Fertil Steril in press.
Vail A and Gardner E (2003) Common statistical errors in the design and analysis of subfertility trials. Hum Reprod 18,10001004.
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