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ISSN: 2375-4508
Journal of Fertilization: In Vitro - IVF-Worldwide, Reproductive Medicine, Genetics & Stem Cell Biology
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Medicine in Digital Age: The Obligation to Report Outcome Puts Infertility and ART in Pole Position for Leaping into the Realm of Digital Medicine

Dominique de Ziegler1*, Zeev Shoham2 and Charles Chapron1
1 Division Reproductive Endocrinology and Infertility, Université Paris Descartes, France
2 Department of Obstetrics and Gynecology, Kaplan Medical Center, Rehovot, Israel
*Corresponding Author : Dominique de Ziegler, MD
Professor and Head
Division Reproductive Endocrinology and Infertility
Université Paris Descartes-Hôp. Cochin
75014 Paris, France
Tel: 33176531616
E-mail: [email protected]
Received March 14, 2014; Accepted May 24, 2014; Published May 26, 2014
Citation: de Ziegler D, Shoham Z, Chapron C (2014) Medicine in Digital Age: The Obligation to Report Outcome Puts Infertility and ART in Pole Position for Leaping into the Realm of Digital Medicine. J Fertil In Vitro IVF Worldw Reprod Med Genet Stem Cell Biol 2:125. doi: 10.4172/jfiv.1000125
Copyright: © 2014 de Ziegler D, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided theoriginal author and source are credited.

 

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Thirty Years Later, Neither 0% nor 100%
An enduring characteristic of assisted reproductive technologies (ART) is the fact that its outcome has remained-as it was at outsetneither 0%, nor 100%. The fact that pregnancy rates (PR) remain in between these extremes has been a source of concerns that lead to further scrutiny from the supervising authorities. Indeed, had pregnancy rates (PR) in ART been either 0% or 100%, the issues discussed today wouldn’t be issues anymore. With PRs of or nearing 0%, ART wouldn’t be an option for treating infertility. At the opposite end, if PRs constantly neared 100%, quality assessment would be greatly simplified, needing less discussion. In the latter case, one single failure would be in itself evidence of a problem in a realm where normally all pregnancy tests should be positive. In case of anesthesia for example, awakening the patient after surgery is expected to be 100% effective. In this context, one single failure is by itself evidence of a problem that needs close and immediate attention.
But, year’s after-over three decades’ later-PRs in ART still hover between 0% and 100%. Of course improvements have been made over time and ART numbers have been steadily rising. In today’s environment, a first attempt at ART in a patient of < 37 years of age is expected to yield PRs of ≥ 50%. Whether actual outcome is either closer to 40%, or 60% do not fundamentally change the problem, which is that ART failures do exist and are thus part of the picture. But how do failures occur? For quality control purposes, it would be nice if a clinic having PRs of say 50% in a given subgroup of patients would witness a predictable alternation of positive and negative outcomes. We however know that this is never the case. Cases-positive and negativetend to cluster for reasons that escape our understanding. Therefore the question is: How many successive negative pregnancy tests exceed what can be explained by chance alone and thus, constitute evidence that a problem occurred and affects ART outcome? Conversely, how many cases are needed in a series of above-average positive pregnancy tests for constituting evidence of an overall improvement in ART efficacy, rather than being an effect of chance alone? With small numbers, it is often hard to tell a true improvement from a bout of good fortune. If they are too hasty, interpretations can easily drift and lead to deceptive reports based on clusters of good cases.
For all these very reasons data reported over limited period of time may be misleading. Considering the sensitive nature of these data and their opaque nature in the past, the public has long been demanding for more non-impeached visibility on ART outcome. As discussed below, this expectation of the public for more transparent information on ART outcome weighed heavily in the decisions taken to mandate that ART centers report their results following a formalized format.
The Obligation to Report Outcome
For the reasons laid out above and because of the highly media sensitive character of infertility issues, ART has been required nearly worldwide to report results to government agencies in standardized fashion. This is notably the case in the US, Canada, and most European countries, Israel, Australia and New Zeeland. In several countries, reports must be made prospectively online within a few days of starting the control ovarian stimulation (COS) cycle.
Issues exist on what ART outcome should be tied to. Classically, results have been computed on per embryo transfer (ET) or per oocyte retrieval bases. Certain claim however that ART outcome ought to be reported instead on per given periods of time during which infertility treatment is provided-i.e. yearly. This is meant to better reflect the relative benefit of the so-called minimal-stimulation ART, which provide smaller oocyte, harvests. Indeed minimal-stimulation ART yields lower per ET results, but can be more frequently repeated over time. Ultimately therefore, minimal stimulation may provide an overall outcome that equals, or certain claim surpasses classical treatments if it is computed on per-year bases. One could also argue that ART data need to be reported according to the cause of infertility as well, as this piece of information may be of public health relevance.
Irrespective of the enduring debate on the mode of reporting ART outcome it is important to note that ART is a nearly unique position by having to conduct those reports. Indeed, only limited other medical activities are required to report such detailed treatment outcomes. As discussed below, having to report outcome can be an asset.
Data Management System for Reporting Outcome
The obligation to report ART data to governmental agencies, which has generalized worldwide, created needs for data management systems capable of preparing and executing such reports. Several systems dedicated to ART are commercially available and chosen by an increasing large number of ART programs. Other groups prefer relying on ‘home-made’ data management systems specially crafted for them. Dedicated systems such as offered by notably, Baby Sentry®, Meditext® and others are gaining interest however. This is in part because they offer novel features such as notably, ‘aps’ that allow patients to check their results and receive their instructions directly on their smart phone. In might be of interest that the authorities requesting the ART reports also look at the systems used by clinicians for generating these reports in order to establish some degree of standardization that might allow some cross talk between these systems.
An important point too would be that data management systems also extract standardized reports targeted at the lay people in order to better inform the infertility population and better respond to their expectations. Indeed the standardization of lay-public reports of ART data would prevent that further degrees of distortion exist in the translations of the existing reports that are made to the public.
Data Reporting, a Burden to Take Advantage of
The obligation to report outcome to government agencies has been perceived as a burden if not an infringement on individual freedom and greeted with moderate enthusiasm in the world of ART. Today however, we must realize that there is no coming back and that the obligation to report outcome is here to stay. Hence, the need for ART reports and the necessity of funneling clinical activity through data management systems capable of conducting such reports should be seen as an opportunity rather than a strain that befell on ART. As discussed below, ART has indeed the unique possibility of showing the way to other areas of medicine on how data reporting systems can open to multiple new uses notably, in education (Figure 1).
Infertility and ART in Pole Position for Leaping in Digital-age Medicine
Data management systems, an opportunity for ART
The need to report outcome actually puts infertility and ART in pole position for leaping forward into the modern realm of digital-age medicine. Infertility and ART are indeed in the privileged position of showing to other fields how to venture into this new frontier of medicine. As discussed below, one of the first possible applications of data management system conceived and implemented for reporting ART data to the government is the domain of education.
A library of virtual cases
ART data management systems-particularly, if coupled with Electronic Medical Records (EMR) constitute a mine of medical information capable of offering far more benefit than merely reporting data to the government. One of the opportunities offered by data management systems originally designed for reporting ART data is to serve as a source of clinical experience capable of illustrating training in this field. For this, we envision a system capable of extracting in an anonym way and storing actual clinical cases encountered in daily infertility and ART practice for further use in education.
A 3D Central Education Unit (CEU)
The clinical cases selected for their ability to illustrate a given segment of infertility treatment and ART treatment must be stored in a system that allows easy on-demand retrieval in order to facilitate practical use in education. For this, we have conceived a ‘Le DU’ central education unit-it is already used by us for storing all classical teaching materials dedicated to infertility and ART-whereby all education materials are stored in individual compartments. As illustrated in Fig. 1, six functional categories exist. The categories are classified following a functional classification that shadows the clinical management of infertility patients, going from the 1. Workup to 2. Diagnosis, 3. Risk assessment, 4. Treatment, 5. Complication and 6. Final assessment steps. Each category contains six compartments in which education materials and virtual cases are stored according to three depths of increasing complexity, categorized as the must-know, nice-to-know and expert levels. The ‘3D’-CEU storage system developed for harboring teaching materials therefore constitutes an ideal basis for also hosting the library of virtual clinical cases meant to serve in education.
Conclusion
Rather than seeing the obligation of reporting data to government agencies solely as a burden, infertility and ART programs should view the existence of data management systems dedicated to that task, as an opportunity. ART data management systems can indeed become the data basis for developing library of virtual cases aimed at exposing doctors in training to circumstances too uncommon for being encountered during their training program (fellowship). Furthermore, standardized reports of ART activity offer a unique opportunity of comparing two facets of medical services emanating from the public and private sectors in a way that should emulate creativity and competition.
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