VIEWS AND REVIEWS
Training in reproductive endocrinology and infertility and assisted reproductive technologies: options and worldwide needs Dominique de Ziegler, M.D.,a Cpt. Nathalie de Ziegler,b Sokteang Sean, M.D.,c Osama Bajouh, M.D.,d and David R. Meldrum, M.D.e Paris Descartes, Paris Sorbonne Cite – Department of Obstetrics and Gynecology and Reproductive Medicine, Universite ^ te Analyse, Paris, France; c Fertility ^ pitaux de Paris, Centre Hospitalier Cochin; b Bureau Enque Assistance Publique Ho Clinic of Cambodia, Phnom Penh, Cambodia; d Department of Obstetrics and Gynecology, King Abdulaziz University, Jeddah, Saudi Arabia; and e Reproductive Partners La Jolla, San Diego, California a
Standardized, high-quality training in reproductive endocrinology, infertility, and assisted reproductive technologies (REI-ART) faces challenges owing to the high-tech nature of ART and the important country-to-country differences in clinical practice and regulations overseeing training. Moreover, while the training capacity of the classical by-fellowship training platforms is shrinking, an increasing demand for REI-ART specialists is coming from emerging countries. To meet this expanding need for REI-ART specialists, we propose a novel by-network model linking a reference training center to satellite practical training sites. Simulation should be used more extensively to achieve competency before initiating live clinical experience, analogous to the highly effective training systems that have been used in aviation for decades. Large ART databases that exist because of obligations to report ART activity and results constitute unique yet so far untapped sources for developing by-scenario simulation training models. Online training materials incorporating these state-of-the-art information technolUse your smartphone ogy tools could be developed as a means of fulfilling training needs worldwide. (Fertil SterilÒ to scan this QR code 2015;-:-–-. Ó2015 by American Society for Reproductive Medicine.) and connect to the Key Words: Reproductive endocrinology, infertility, training, medical simulation, network Discuss: You can discuss this article with its authors and with other ASRM members at http:// fertstertforum.com/dezieglerd-training-rei-art/
P
rofessional training is essential for the safety and efficacy of any complex operation, and medicine is no exception (1). In medicine, professional (clinical) training overlaps with academic education. The former, gained through basic medical, specialty, and subspecialty training, aims at optimizing the safety and efficacy of patient management.
The latter, anchored in the higher spheres of science, looks for new clues and tools for improving clinical care. By the nature of its activities—ranging from micromanipulating fertilization to genetically assessing embryos— reproductive endocrinology, infertility, and assisted reproductive technologies (REI-ART) relies on both for excellence.
Received March 9, 2015; revised March 31, 2015; accepted April 20, 2015. D.d.Z. has nothing to disclose. N.d.Z. has nothing to disclose. S.S. has nothing to disclose. O.B. has nothing to disclose. D.R.M. has nothing to disclose. Reprint requests: Dominique de Ziegler, M.D., Professor and Head, Reproductive Endocrinology and cologie Obste trique II, Groupe d'Ho ^ pitaux Paris Centre Cochin Broca Infertility, Service de Gyne ^ tel Dieu, Ho ^ pital Cochin, 53, Avenue de l'Observatoire, 75014 Paris, France (E-mail: Ho [email protected]). Fertility and Sterility® Vol. -, No. -, - 2015 0015-0282/$36.00 Copyright ©2015 American Society for Reproductive Medicine, Published by Elsevier Inc. http://dx.doi.org/10.1016/j.fertnstert.2015.04.031 VOL. - NO. - / - 2015
discussion forum for this article now.*
* Download a free QR code scanner by searching for “QR scanner” in your smartphone’s app store or app marketplace.
The training of REI-ART specialists confronts important country-tocountry differences in clinical practice and regulatory dispositions overseeing such training. These differences, which cause a lack of standardization in the worldwide treatment of infertility, also have an impact on training modalities, leaving us ill prepared for fulfilling the increasing needs for REI-ART specialists that are emanating from emerging countries. New training options therefore need to be envisioned, together with efforts from international societies and United Nations–related agencies for standardizing training modalities and in turn REI-ART practices. When discussing these issues, cogent comparisons are made by one 1
VIEWS AND REVIEWS of us (N.D.Z.) with the regulations overseeing training in a different discipline, aviation. Indeed, aviation has capably managed the challenge of achieving high international standards of performance in a field encompassing similarly advanced degrees of technical competence and knowledge in a constantly evolving profession. Herein we will discuss how similar progress could be achieved with REI-ART training.
REI-ART: INTERNATIONAL BY PRACTICE, COUNTRY-SPECIFIC BY REGULATION Needs for REI-ART Specialists REI-ART activities vary considerably across the world. In 2007, the number of ART cycles per million (Mi) population ranged from 79/Mi in India to 584/Mi in the United States and 1,135/Mi in France (2). Logically, the needs for REIART specialists are directly related to ART activity in each country. The above data notwithstanding, the worldwide need for REI-ART specialists is also experiencing an increasing demand from emerging countries that is sparked by their rapidly expanding middle classes (3).
Different Regulatory Systems ART has rapidly become one of the most supervised activities of medicine, but with regulatory measures that vary from country to country. The tight regulatory supervision of ART activity is rooted in the following two reasons: [1] From its inception, ART has been extremely media sensitive and prone to catch or inflame people's imaginations, with persistent high levels of media exposure. [2] Over the early years of ART, results cited for individual ART programs widely fluctuated. This was due to varying levels of expertise, reporting over arbitrary time intervals, or even reporting of national or published results as being representative of those to be expected by infertile couples in a local ART program. Such misuses of ART data have sparked backlashes across the world, with authorities mandating nearly everywhere that ART data must be reported following defined formats, usually to a national registry and often available to patients.
Different Financial Models Despite not being necessarily linked to an identifiable ailment, infertility is considered a disease. According to the International Committee for Monitoring Assisted Reproductive Technologies, infertility is ‘‘a disease of the reproductive system characterized by the failure to achieve a clinical pregnancy after R12 months of regular unprotected intercourse’’ (4). While infertility is officially a disease (4), infertility treatments—particularly ART—are still excluded from reimbursement in many countries. Hybrid options also exist, whereby ART alone is excluded from reimbursement, while infertility per se is covered. The Swiss High Court, for example, reiterated in 2011 that ART is excluded from mandatory reimbursement because it is experimental and of unproven efficacy (http://relevancy.bger.ch/php/aza/http/index.php?lang¼de 2
&zoom¼&type¼show_document&highlight_docid¼aza% 3A%2F%2F01-10-2012-9C_835-2011)! Such rulings create incentives for energetic non-ART ovarian stimulations—the ‘‘poor man's ART’’—increasing the risk of highorder multiple pregnancies that trainees need to be taught to avoid. Finally, in countries where ART is covered by insurance, certain financial rulings may also affect clinical practice. For example, authorities in Belgium have tied ART reimbursement to limiting the number of embryos transferred—one in most cases (5). These measures and similar ones in Turkey (6) and Quebec Province (7) have affected ART activity. To reduce multiple pregnancies and obstetrical costs and morbidity, they have increased overall ART activity, generally without having an impact on cumulative delivery rates.
Ethical and Administrative Restrictions A great disparity exists in the nature and extent of ethical and administrative restrictions that surround infertility treatments and notably ART. In certain countries, restrictive regulations bar doctors from using certain new ART advances. Genetically screening blastocysts (preimplantation genetic screening; PGS) to allow transfer of a single euploid embryo (8) without reducing the per-ET success rates (9) is banned in France, for example. For training, such bans will lead to ignorance unless REI-ART specialists are taught the intricacies of PGS-related measures despite local prohibitions. The ethical and/or administrative restrictions affecting ART are too numerous to list here. It suffices to say that the training of REI-ART specialists must cover all treatment options and measures that are deemed medically justified, even if not allowed locally, and particularly must facilitate cross-border care. Also, with time, ethical prohibitions tend to be removed when procedures become widely accepted elsewhere.
Different Subspecialty Certifications Training in REI-ART is regulated in North America and most European countries. The range of competence expected from REI-ART specialists remains a matter for debate and is evolving (10). In the United States, REI became a subspecialty of gynecology before ART existed. It therefore retains in its curriculum a broad theoretical knowledge that spans the entire REI domain. ART, however, because of its rapid adoption as a central fertility treatment and its markedly increasing success rates, has had a profound impact on the subspecialty itself (11). In Europe, training in REI-ART—sometimes called ‘‘advanced training’’—started being regulated after ART already existed. Certain countries—Switzerland, for example—offer ‘‘a la carte’’ models that grant advanced training certificates based on selecting only certain domains of expertise. As stressed by Sigman, the ultimate parameter that justifies expanding or restricting the extent of the subspecialty is when such changes will positively impact on the quality of patient care (12). VOL. - NO. - / - 2015
Fertility and Sterility® Academic and Private REI-ART Centers
Models from Other Industries
Because of its high-tech nature, one would have predicted at its inception that ART would primarily flourish in the academic sector. While this prophecy first appeared true—intyracytoplasmic sperm injection was created in an academic institution—the course of ART ultimately evolved differently. In the late nineties, Gardner and Schoolcraft's team working in a private ART clinic in Colorado was instrumental in the development of techniques for improved development of human embryos to the blastocyst stage (13) in sequential media tailored to embryo metabolic requirements at different stages of development (14). It was again a private ART program that first published on oocyte vitrification in 2008 (15, 16). More recently, it was also a private ART program that reported a randomized controlled trial on the value of transferring single genetically tested euploid blastocysts as compared with transfer of two untested blastocysts (9). In a provocative article, Soules queried whether private ART might have been detrimental to academic REI (17). This author contended that the sheer efficacy of ART—particularly in the United States—makes other infertility treatments, for example, tubal surgery, obsolete. Furthermore, the primarily private development of ART may interfere with the training of REI-ART specialists if this depends solely on the academic sector and no adjustments are done, as discussed below.
Other regulated industries have established different and often more functional types of regulator-operator interactions for overseeing their initial and recurrent training. Aviation, well known for nurturing advanced risk and safety management systems (1), also developed highly effective regulator-operator models for controlling training. These astutely mingle the needs of industry—the airlines—with the concerns of the supervising authority—that is, the Federal Aviation Agency (FAA). While defining the training domains for flight crews, the FAA also ‘‘encourages operators to be innovative and creative when developing training methods and techniques’’ http://www.faa.gov/licenses_certificates/airline_ certification/media/ntng_pro.doc). To make training as effective and focused as practically possible, the agency passes on to the trainer the responsibility of defining the training modalities: ‘‘although the FAA inspector may provide advice and guidance to the training provider, the development of the final training program submitted to the FAA is solely the responsibility of the training provider.’’ This regulator-operator relationship is therefore both top-down—instructions and framework given—and bottom-up—responsibility passed on to the operator for final definition of the training program. The functionality of such combined top-down and bottom-up regulator-operator interactions could inspire constructive changes in regulatory models in medicine. We believe that the predominantly one-way top-down regulation of professional training in REI-ART should be remedied in the interest of efficacy and safety, with appropriate pressure from medical societies.
TOP-DOWN AND BOTTOM-UP REGULATION ART Regulation As indicated above, ART activity and training are regulated in nearly all industrialized countries. This includes the obligation of periodically reporting ART activity, results, and complications. Practically, the stipulations defining how this is done—format, type of data, periodicity, and so on,—greatly differ from country to country. Moreover, intercountry differences also sometimes exist in how ART data are used by the regulator. In the United States, ART data are publicly accessible to infertile couples to aid in selection of a treatment provider. In Switzerland, the ART centers cannot be identified (18). In France, only weighted data, adjusted for the patients' age and other parameters, are available, as this is judged more informative for patients (http://www.agence-biomedecine.fr/AMP?lang¼fr). Generally, the regulations for [1] data reporting and [2] certifying ART activity and training are performed by the regulator and imposed on the operators following a topdown organization. With various degrees of input from groups of practitioners—depending on the countries—the regulator simply tells the operator—the ART center—what to do and how to do it. This operative mode is rather rigid and slow to implement, sometimes imposing guidelines that may be already outdated when issued. Moreover, regulations of the top-down type—whether dealing with clinical practice or controlling training—commonly govern one step of the process at a time. In reality, to be effective, clinical measures or training dispositions should be chosen as multiple-step or route strategies, rather than individually. VOL. - NO. - / - 2015
THE NEEDS OF OUR PROFESSION Problem Statement Training in REI-ART must produce specialists who offer the best—most efficient and safest—infertility care worldwide. This relies on acquiring [1] a theoretical curriculum of sufficient breadth and [2] practical skills—technical and clinical—covering the entire span of necessary competence, and [3] conducting research or a thesis project for the teaching of intelligent handling of available medical data.
Classical Fellowship-type Training Classically, all REI-ART subspecialists were trained in fellowship programs attached to academic institutions. This training modality, however, confronts a recent trend—in the United States and elsewhere—for major ART programs to primarily operate in the private sector, thus outside of classical academic-based fellowships (17). The risk therefore is that REI-ART fellows may be underexposed to high-end ART techniques if these are not performed, or are performed infrequently, in academic institutions. To alleviate possible harm to the quality of REI-ART training, several joint academicprivate collaborations have been successfully established between top ART centers and well-known academic institutions. One of us (D.R.M.) has been involved in establishing a 3
VIEWS AND REVIEWS
FIGURE 1
Theoretical curriculum accompanying REI-ART training encompassing a comprehensive—initial and final (validation)—course and series of 11–13 special advanced courses. de Ziegler. Training in REI-ART. Fertil Steril 2015.
successful collaboration—the Reproductive Partners-UCSD Regional Fertility Center—between a private ART center and an academic institution, the division of Reproductive Endocrinology of the University of California in San Diego (UCSD). Other successful collaborations between private ART centers and academic institutions exist throughout the United States—and should be developed abroad—to provide optimal training of REI-ART fellows.
Alternate By-network Training The rapidly increasing need for REI-ART specialists confronts a parallel shrinking of the ability of classical fellowship programs to accommodate foreign medical graduates. This situation therefore calls for developing innovative training modalities, such as the by-network training option, whereby institutions could team up to provide the theoretical and practical training.
Theory: Initial and Advanced Courses As stated earlier and discussed in other articles of this series of Views and Reviews, the breadth of REI-ART theoretical curriculums is defined in most countries, but with considerable country-to-country differences. Figure 1 illustrates a possible format for covering a series of topics that fulfill the North American recommendations. Typically, this format distinguishes two parts: [1] a generalized course curriculum possibly covered by two—initial and final or validating—5day sessions; and [2] sets of 11–13 specialized advanced 2– 3 day modules assuring the proper horizontal extension of knowledge, as offered, for example, by the list of topics emanating from the Royal College of Physicians of Canada (Table 1). These modules should be experienced over the 2to 3-year duration of the subspecialty training.
Practical Training Sites Practical training amounts to a clinical immersion in all the facets of everyday REI-ART practice, as typically offered during certified fellowships. Contrary to the theoretical courses, 4
practical training is currently more loosely controlled by regulators. These regulators most often assess only the number of cases and/or test candidates on their understanding of their individual case list during the final examination. The practical activity at the training site itself—overall activity, adherence to protocols, review of results, and quality assessment—is little controlled if at all in the specialty certification processes. Practical training offered in other industries such as aviation is again more functionally structured and assessed. In aviation, line training is the process by which the fieldwork of airline pilots—their performance in the cockpit—is followed and assessed. The line training modalities are defined by the operator—the airline—and ultimately certified and implemented after review by the regulator. Moreover, line training is assured by the operator for which the pilot flies, not by a distant academic institution. In medicine, it would be similarly constructive to consider the possibility of certifying practical training sites and programs on the basis of the global merit of their training package, irrespective of whether it was in an academic or private institution. As discussed below, practical and theoretical training could be offered at different sites.
TABLE 1 Extent of the theoretical curriculum accompanying REI-ART training recommended by the Royal College of Physicians and Surgeons of Canada. REI-ART: example of theoretical curriculum Minimally invasive surgery Medical endocrinology Pediatric and adolescent gynecology Menopause Urology/andrology Gynecologic ultrasound/radiology Genetics Clinical epidemiology and biostatistics Clinical investigation in GREI Bioethics Sex and couples therapy clinic de Ziegler. Training in REI-ART. Fertil Steril 2015.
VOL. - NO. - / - 2015
Fertility and Sterility® Novel By-network Training Options
Education with a ‘‘Safety Inside’’ Spirit
Administrative restrictions in the United Sates and Europe (19) have limited the possibilities of training foreign graduates, and novel training options are needed and, particularly, new certified practical training sites in REI-ART. The new practical training sites—typically accommodating one to three trainees simultaneously—would be certified on the basis of merit, as described below. One or several training sites would dovetail with a corresponding reference center hence, the bynetwork concept. The reference center would be responsible for delivering the theoretical curriculum and supervising each applicant and his/her thesis project and the affiliated training sites. As illustrated in Figure 2, by-network training is envisioned to rely on the following 3 components: A theoretical curriculum covering the full breadth of knowledge defined by the most stringent available regulators, with two comprehensive initial and final (validation) courses and 11–13 special advanced courses, as illustrated in Figure 1. Hands-on practical training would be offered at certified and supervised training sites participating in the by-network training program. Each participating site would be certified for training a given number of candidates on the basis of in-depth reviews of their clinical activity (volume, span of services, adherence to protocols, and access to data review). Research and thesis—as an important part of REI-ART training—would be conducted under the supervision of a thesis director. The financial model of by-network training still needs to be elaborated. Ideally, the trainee or institution supporting him/her and/or future employers would be responsible for the training fees of the theoretical curriculum. Other models would oversee the practical training, whereby one would expect the trainee to receive some stipend for his/her work as a person in training.
New medical education programs must be conceived from inception with concerns for risk and safety management. Training in REI-ART is no exception. Hence, the fundamentals of safety management—identifying hazards and risks, choosing and positioning defenses, and so on—must be integrated into the training curriculum (1). Ultimately, therefore, the REI-ART training programs must be conceived with a ‘‘safety inside’’ spirit. As addressed below, we foresee an increasing use of simulation as an adjunct to both the theoretical and practical parts of training.
FIGURE 2
International Integration Differences in REI-ART practices across the world primarily stem from divergent payment modalities, regulatory rulings, and ethical bans. Aviation may again be instructive when trying to integrate worldwide REI-ART practice standards. Indeed, the International Civil Aviation Organization (ICAO)—a UN-dependent structure laid out in 1944—develops the Standards and Recommended Practices (SARPs) for guiding national regulators in adopting SARP-compatible laws locally. This again leaves medicine far behind. One should stress therefore that the international societies representing gynecologists and urologists look at ICAO's role in aviation and strive to similarly standardize infertility-ART management worldwide.
BY-SIMULATION IN REI-ART Problem Statement By-simulation training is a novel education strategy gaining interest in medicine, which may progressively complement the efficacy of initial and continuing training courses. Generally, the efficacy of by-simulation training has not been demonstrated beyond an elementary introduction to certain procedures. Yet REI-ART may be a test case for expanding by-simulation training because the large databases resulting from the obligation of reporting outcomes are unique sources of realistic training scenarios.
Simulation in Aviation and Medicine
New REI-ART training option featuring a by-network regrouping and theory, certified practical training sites, and supervising training center. de Ziegler. Training in REI-ART. Fertil Steril 2015.
VOL. - NO. - / - 2015
Aviation relies extensively on by-simulation training. The public knows about flight simulators—boxes moving on long telescopic legs—that are used for training airline pilots. Their various applications are less known, however. In aviation, simulators serve for the following: Simulating flying at a lower cost than a modern jetliner. Simulating flying conditions that are too uncommon for anyone to be competent at handling them. Without flight simulators it would be impossible—and dangerous—to train pilots to competently handle extreme scenarios. It is, for example, evident that training for ‘‘engine-out situations while landing, in adverse meteorological conditions at night’’ could not be done. In medicine, the distinction between the above two functions of simulation is less clear. This is because teaching of new technical skills—the ‘‘flying’’—and the handling of rare 5
VIEWS AND REVIEWS occurrences—the ‘‘engine-out’’—commonly rely on different supports. Technical devices—the medical simulators—typically serve the former, while the latter mainly rely on scenario-type models. One day however, with larger uses of virtual world systems, we foresee that the better use of simulation in medicine will ultimately, like in aviation, nurture competence at handling the rare and unexpected. In aviation, a flight is successful if it takes off and lands without incident; ART is successful only if the procedure results in a successful birth. It should be as unacceptable for training to have an impact on ART success if simulation is available.
Medical Simulators Medical simulators—technical devices—have been designed for training doctors more rapidly and efficiently to perform certain procedures, such as, for example, laparoscopies (20, 21) or coloscopies (22). In both instances, the simulators helped transfer the skills required for performing these procedures to novices (20, 22). Simulation for teaching doctors how to perform obstetrical ultrasounds led to similar conclusions, showing that beginners quickly approached near-expert levels at performing normal ultrasounds (23). However, the usefulness of these approaches in advanced training is so far less clear. This discrepancy suggests that medical simulators mainly reproduce the normal flying, but not yet the improbable engine-out type situation.
Scenario-based Training Scenario-based training is a nontechnological—narrativedependent—method for simulating uncommon and rarely occurring clinical situations. Aimed at teaching safety reflexes for optimizing clinical management, they are currently targeted at the initial training stages (24). The primary challenge for further expanding the scenario-based by-simulation training in medicine is to be able to feed these systems with complex yet highly realistic clinical scripts. Here the very large ART databases established in parallel with obligatory ART reporting offer unique opportunities. Indeed, ART databases are untapped mines for scenarios of uncommon clinical occurrences of real world incidents otherwise altered when retrieved from memory only (25, 26).
Dyad or in Pairs Simulation-based Training Dyad or in-pairs type training is a way to improve the efficiency and reduce the time and cost of by-simulation programs by teaching two trainees at a time (27, 28). A dyad approach should be developed and tested for improving the training of REI-ART fellows at performing ETs.
Virtual Worlds Virtual worlds are rapidly becoming part of the educational landscape (29). Second Life (SL)—one of the best known of these environments (29)—offers a virtual hospital support for training health-related activities and improving real life behaviors (30). In a 1-hour SL-based interactive course on type 6
2 diabetes management (29), the participants improved their ability at selecting the initial insulin dose and conducting further adjustments. Here again, simulation is so far used for the very initial stages of training. We are not aware of any virtual reality program for REI-ART targeted at physicians, paramedical personnel, or patients. Certain models may soon exist, however, considering the amazingly rapid expansion and immense possibilities of virtual world–based education and smart game–type products.
Simulated ET One training deficiency that is documented as undermining many American REI-ART fellowships, and in turn the clinical care offered by those individuals, is the insufficient ET experience gained during the fellowship. Too many fellows finish their 3-year training without having done enough—at times, even none—actual ETs. This deficiency is commonly justified by indicating that it is improper to let untrained fellows do ETs in patients who pay for their treatments. While the argument may appear reasonable at first glance, actually it is not. Indeed there are many other industries where similar dilemmas have been dealt with to everyone's satisfaction. Using by-simulation and intelligent training modules, it is indeed possible to ascertain that trainees—in this case, REI-ART fellows—have become proficient at doing certain common tasks, for example, ETs, even before having performed an actual live procedure. In a recent publication, Lopez et al. used a cumulative summation (CUSUM) approach—originally developed in industry—for assessing the time taken for asserting competence (31). Using this approach, the authors determined that the five trainees became proficient at doing ET by procedure 15 at the latest (after procedure 15, 9, 7, 13 and 9) (31). Importantly, the pregnancy rates were lower when trainees had between-ET intervals of R10 days, as compared with
Training in reproductive endocrinology and infertility and assisted reproductive technologies: options and worldwide needs Dominique de Ziegler, M.D.,a Cpt. Nathalie de Ziegler,b Sokteang Sean, M.D.,c Osama Bajouh, M.D.,d and David R. Meldrum, M.D.e Paris Descartes, Paris Sorbonne Cite – Department of Obstetrics and Gynecology and Reproductive Medicine, Universite ^ te Analyse, Paris, France; c Fertility ^ pitaux de Paris, Centre Hospitalier Cochin; b Bureau Enque Assistance Publique Ho Clinic of Cambodia, Phnom Penh, Cambodia; d Department of Obstetrics and Gynecology, King Abdulaziz University, Jeddah, Saudi Arabia; and e Reproductive Partners La Jolla, San Diego, California a
Standardized, high-quality training in reproductive endocrinology, infertility, and assisted reproductive technologies (REI-ART) faces challenges owing to the high-tech nature of ART and the important country-to-country differences in clinical practice and regulations overseeing training. Moreover, while the training capacity of the classical by-fellowship training platforms is shrinking, an increasing demand for REI-ART specialists is coming from emerging countries. To meet this expanding need for REI-ART specialists, we propose a novel by-network model linking a reference training center to satellite practical training sites. Simulation should be used more extensively to achieve competency before initiating live clinical experience, analogous to the highly effective training systems that have been used in aviation for decades. Large ART databases that exist because of obligations to report ART activity and results constitute unique yet so far untapped sources for developing by-scenario simulation training models. Online training materials incorporating these state-of-the-art information technolUse your smartphone ogy tools could be developed as a means of fulfilling training needs worldwide. (Fertil SterilÒ to scan this QR code 2015;-:-–-. Ó2015 by American Society for Reproductive Medicine.) and connect to the Key Words: Reproductive endocrinology, infertility, training, medical simulation, network Discuss: You can discuss this article with its authors and with other ASRM members at http:// fertstertforum.com/dezieglerd-training-rei-art/
P
rofessional training is essential for the safety and efficacy of any complex operation, and medicine is no exception (1). In medicine, professional (clinical) training overlaps with academic education. The former, gained through basic medical, specialty, and subspecialty training, aims at optimizing the safety and efficacy of patient management.
The latter, anchored in the higher spheres of science, looks for new clues and tools for improving clinical care. By the nature of its activities—ranging from micromanipulating fertilization to genetically assessing embryos— reproductive endocrinology, infertility, and assisted reproductive technologies (REI-ART) relies on both for excellence.
Received March 9, 2015; revised March 31, 2015; accepted April 20, 2015. D.d.Z. has nothing to disclose. N.d.Z. has nothing to disclose. S.S. has nothing to disclose. O.B. has nothing to disclose. D.R.M. has nothing to disclose. Reprint requests: Dominique de Ziegler, M.D., Professor and Head, Reproductive Endocrinology and cologie Obste trique II, Groupe d'Ho ^ pitaux Paris Centre Cochin Broca Infertility, Service de Gyne ^ tel Dieu, Ho ^ pital Cochin, 53, Avenue de l'Observatoire, 75014 Paris, France (E-mail: Ho [email protected]). Fertility and Sterility® Vol. -, No. -, - 2015 0015-0282/$36.00 Copyright ©2015 American Society for Reproductive Medicine, Published by Elsevier Inc. http://dx.doi.org/10.1016/j.fertnstert.2015.04.031 VOL. - NO. - / - 2015
discussion forum for this article now.*
* Download a free QR code scanner by searching for “QR scanner” in your smartphone’s app store or app marketplace.
The training of REI-ART specialists confronts important country-tocountry differences in clinical practice and regulatory dispositions overseeing such training. These differences, which cause a lack of standardization in the worldwide treatment of infertility, also have an impact on training modalities, leaving us ill prepared for fulfilling the increasing needs for REI-ART specialists that are emanating from emerging countries. New training options therefore need to be envisioned, together with efforts from international societies and United Nations–related agencies for standardizing training modalities and in turn REI-ART practices. When discussing these issues, cogent comparisons are made by one 1
VIEWS AND REVIEWS of us (N.D.Z.) with the regulations overseeing training in a different discipline, aviation. Indeed, aviation has capably managed the challenge of achieving high international standards of performance in a field encompassing similarly advanced degrees of technical competence and knowledge in a constantly evolving profession. Herein we will discuss how similar progress could be achieved with REI-ART training.
REI-ART: INTERNATIONAL BY PRACTICE, COUNTRY-SPECIFIC BY REGULATION Needs for REI-ART Specialists REI-ART activities vary considerably across the world. In 2007, the number of ART cycles per million (Mi) population ranged from 79/Mi in India to 584/Mi in the United States and 1,135/Mi in France (2). Logically, the needs for REIART specialists are directly related to ART activity in each country. The above data notwithstanding, the worldwide need for REI-ART specialists is also experiencing an increasing demand from emerging countries that is sparked by their rapidly expanding middle classes (3).
Different Regulatory Systems ART has rapidly become one of the most supervised activities of medicine, but with regulatory measures that vary from country to country. The tight regulatory supervision of ART activity is rooted in the following two reasons: [1] From its inception, ART has been extremely media sensitive and prone to catch or inflame people's imaginations, with persistent high levels of media exposure. [2] Over the early years of ART, results cited for individual ART programs widely fluctuated. This was due to varying levels of expertise, reporting over arbitrary time intervals, or even reporting of national or published results as being representative of those to be expected by infertile couples in a local ART program. Such misuses of ART data have sparked backlashes across the world, with authorities mandating nearly everywhere that ART data must be reported following defined formats, usually to a national registry and often available to patients.
Different Financial Models Despite not being necessarily linked to an identifiable ailment, infertility is considered a disease. According to the International Committee for Monitoring Assisted Reproductive Technologies, infertility is ‘‘a disease of the reproductive system characterized by the failure to achieve a clinical pregnancy after R12 months of regular unprotected intercourse’’ (4). While infertility is officially a disease (4), infertility treatments—particularly ART—are still excluded from reimbursement in many countries. Hybrid options also exist, whereby ART alone is excluded from reimbursement, while infertility per se is covered. The Swiss High Court, for example, reiterated in 2011 that ART is excluded from mandatory reimbursement because it is experimental and of unproven efficacy (http://relevancy.bger.ch/php/aza/http/index.php?lang¼de 2
&zoom¼&type¼show_document&highlight_docid¼aza% 3A%2F%2F01-10-2012-9C_835-2011)! Such rulings create incentives for energetic non-ART ovarian stimulations—the ‘‘poor man's ART’’—increasing the risk of highorder multiple pregnancies that trainees need to be taught to avoid. Finally, in countries where ART is covered by insurance, certain financial rulings may also affect clinical practice. For example, authorities in Belgium have tied ART reimbursement to limiting the number of embryos transferred—one in most cases (5). These measures and similar ones in Turkey (6) and Quebec Province (7) have affected ART activity. To reduce multiple pregnancies and obstetrical costs and morbidity, they have increased overall ART activity, generally without having an impact on cumulative delivery rates.
Ethical and Administrative Restrictions A great disparity exists in the nature and extent of ethical and administrative restrictions that surround infertility treatments and notably ART. In certain countries, restrictive regulations bar doctors from using certain new ART advances. Genetically screening blastocysts (preimplantation genetic screening; PGS) to allow transfer of a single euploid embryo (8) without reducing the per-ET success rates (9) is banned in France, for example. For training, such bans will lead to ignorance unless REI-ART specialists are taught the intricacies of PGS-related measures despite local prohibitions. The ethical and/or administrative restrictions affecting ART are too numerous to list here. It suffices to say that the training of REI-ART specialists must cover all treatment options and measures that are deemed medically justified, even if not allowed locally, and particularly must facilitate cross-border care. Also, with time, ethical prohibitions tend to be removed when procedures become widely accepted elsewhere.
Different Subspecialty Certifications Training in REI-ART is regulated in North America and most European countries. The range of competence expected from REI-ART specialists remains a matter for debate and is evolving (10). In the United States, REI became a subspecialty of gynecology before ART existed. It therefore retains in its curriculum a broad theoretical knowledge that spans the entire REI domain. ART, however, because of its rapid adoption as a central fertility treatment and its markedly increasing success rates, has had a profound impact on the subspecialty itself (11). In Europe, training in REI-ART—sometimes called ‘‘advanced training’’—started being regulated after ART already existed. Certain countries—Switzerland, for example—offer ‘‘a la carte’’ models that grant advanced training certificates based on selecting only certain domains of expertise. As stressed by Sigman, the ultimate parameter that justifies expanding or restricting the extent of the subspecialty is when such changes will positively impact on the quality of patient care (12). VOL. - NO. - / - 2015
Fertility and Sterility® Academic and Private REI-ART Centers
Models from Other Industries
Because of its high-tech nature, one would have predicted at its inception that ART would primarily flourish in the academic sector. While this prophecy first appeared true—intyracytoplasmic sperm injection was created in an academic institution—the course of ART ultimately evolved differently. In the late nineties, Gardner and Schoolcraft's team working in a private ART clinic in Colorado was instrumental in the development of techniques for improved development of human embryos to the blastocyst stage (13) in sequential media tailored to embryo metabolic requirements at different stages of development (14). It was again a private ART program that first published on oocyte vitrification in 2008 (15, 16). More recently, it was also a private ART program that reported a randomized controlled trial on the value of transferring single genetically tested euploid blastocysts as compared with transfer of two untested blastocysts (9). In a provocative article, Soules queried whether private ART might have been detrimental to academic REI (17). This author contended that the sheer efficacy of ART—particularly in the United States—makes other infertility treatments, for example, tubal surgery, obsolete. Furthermore, the primarily private development of ART may interfere with the training of REI-ART specialists if this depends solely on the academic sector and no adjustments are done, as discussed below.
Other regulated industries have established different and often more functional types of regulator-operator interactions for overseeing their initial and recurrent training. Aviation, well known for nurturing advanced risk and safety management systems (1), also developed highly effective regulator-operator models for controlling training. These astutely mingle the needs of industry—the airlines—with the concerns of the supervising authority—that is, the Federal Aviation Agency (FAA). While defining the training domains for flight crews, the FAA also ‘‘encourages operators to be innovative and creative when developing training methods and techniques’’ http://www.faa.gov/licenses_certificates/airline_ certification/media/ntng_pro.doc). To make training as effective and focused as practically possible, the agency passes on to the trainer the responsibility of defining the training modalities: ‘‘although the FAA inspector may provide advice and guidance to the training provider, the development of the final training program submitted to the FAA is solely the responsibility of the training provider.’’ This regulator-operator relationship is therefore both top-down—instructions and framework given—and bottom-up—responsibility passed on to the operator for final definition of the training program. The functionality of such combined top-down and bottom-up regulator-operator interactions could inspire constructive changes in regulatory models in medicine. We believe that the predominantly one-way top-down regulation of professional training in REI-ART should be remedied in the interest of efficacy and safety, with appropriate pressure from medical societies.
TOP-DOWN AND BOTTOM-UP REGULATION ART Regulation As indicated above, ART activity and training are regulated in nearly all industrialized countries. This includes the obligation of periodically reporting ART activity, results, and complications. Practically, the stipulations defining how this is done—format, type of data, periodicity, and so on,—greatly differ from country to country. Moreover, intercountry differences also sometimes exist in how ART data are used by the regulator. In the United States, ART data are publicly accessible to infertile couples to aid in selection of a treatment provider. In Switzerland, the ART centers cannot be identified (18). In France, only weighted data, adjusted for the patients' age and other parameters, are available, as this is judged more informative for patients (http://www.agence-biomedecine.fr/AMP?lang¼fr). Generally, the regulations for [1] data reporting and [2] certifying ART activity and training are performed by the regulator and imposed on the operators following a topdown organization. With various degrees of input from groups of practitioners—depending on the countries—the regulator simply tells the operator—the ART center—what to do and how to do it. This operative mode is rather rigid and slow to implement, sometimes imposing guidelines that may be already outdated when issued. Moreover, regulations of the top-down type—whether dealing with clinical practice or controlling training—commonly govern one step of the process at a time. In reality, to be effective, clinical measures or training dispositions should be chosen as multiple-step or route strategies, rather than individually. VOL. - NO. - / - 2015
THE NEEDS OF OUR PROFESSION Problem Statement Training in REI-ART must produce specialists who offer the best—most efficient and safest—infertility care worldwide. This relies on acquiring [1] a theoretical curriculum of sufficient breadth and [2] practical skills—technical and clinical—covering the entire span of necessary competence, and [3] conducting research or a thesis project for the teaching of intelligent handling of available medical data.
Classical Fellowship-type Training Classically, all REI-ART subspecialists were trained in fellowship programs attached to academic institutions. This training modality, however, confronts a recent trend—in the United States and elsewhere—for major ART programs to primarily operate in the private sector, thus outside of classical academic-based fellowships (17). The risk therefore is that REI-ART fellows may be underexposed to high-end ART techniques if these are not performed, or are performed infrequently, in academic institutions. To alleviate possible harm to the quality of REI-ART training, several joint academicprivate collaborations have been successfully established between top ART centers and well-known academic institutions. One of us (D.R.M.) has been involved in establishing a 3
VIEWS AND REVIEWS
FIGURE 1
Theoretical curriculum accompanying REI-ART training encompassing a comprehensive—initial and final (validation)—course and series of 11–13 special advanced courses. de Ziegler. Training in REI-ART. Fertil Steril 2015.
successful collaboration—the Reproductive Partners-UCSD Regional Fertility Center—between a private ART center and an academic institution, the division of Reproductive Endocrinology of the University of California in San Diego (UCSD). Other successful collaborations between private ART centers and academic institutions exist throughout the United States—and should be developed abroad—to provide optimal training of REI-ART fellows.
Alternate By-network Training The rapidly increasing need for REI-ART specialists confronts a parallel shrinking of the ability of classical fellowship programs to accommodate foreign medical graduates. This situation therefore calls for developing innovative training modalities, such as the by-network training option, whereby institutions could team up to provide the theoretical and practical training.
Theory: Initial and Advanced Courses As stated earlier and discussed in other articles of this series of Views and Reviews, the breadth of REI-ART theoretical curriculums is defined in most countries, but with considerable country-to-country differences. Figure 1 illustrates a possible format for covering a series of topics that fulfill the North American recommendations. Typically, this format distinguishes two parts: [1] a generalized course curriculum possibly covered by two—initial and final or validating—5day sessions; and [2] sets of 11–13 specialized advanced 2– 3 day modules assuring the proper horizontal extension of knowledge, as offered, for example, by the list of topics emanating from the Royal College of Physicians of Canada (Table 1). These modules should be experienced over the 2to 3-year duration of the subspecialty training.
Practical Training Sites Practical training amounts to a clinical immersion in all the facets of everyday REI-ART practice, as typically offered during certified fellowships. Contrary to the theoretical courses, 4
practical training is currently more loosely controlled by regulators. These regulators most often assess only the number of cases and/or test candidates on their understanding of their individual case list during the final examination. The practical activity at the training site itself—overall activity, adherence to protocols, review of results, and quality assessment—is little controlled if at all in the specialty certification processes. Practical training offered in other industries such as aviation is again more functionally structured and assessed. In aviation, line training is the process by which the fieldwork of airline pilots—their performance in the cockpit—is followed and assessed. The line training modalities are defined by the operator—the airline—and ultimately certified and implemented after review by the regulator. Moreover, line training is assured by the operator for which the pilot flies, not by a distant academic institution. In medicine, it would be similarly constructive to consider the possibility of certifying practical training sites and programs on the basis of the global merit of their training package, irrespective of whether it was in an academic or private institution. As discussed below, practical and theoretical training could be offered at different sites.
TABLE 1 Extent of the theoretical curriculum accompanying REI-ART training recommended by the Royal College of Physicians and Surgeons of Canada. REI-ART: example of theoretical curriculum Minimally invasive surgery Medical endocrinology Pediatric and adolescent gynecology Menopause Urology/andrology Gynecologic ultrasound/radiology Genetics Clinical epidemiology and biostatistics Clinical investigation in GREI Bioethics Sex and couples therapy clinic de Ziegler. Training in REI-ART. Fertil Steril 2015.
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Fertility and Sterility® Novel By-network Training Options
Education with a ‘‘Safety Inside’’ Spirit
Administrative restrictions in the United Sates and Europe (19) have limited the possibilities of training foreign graduates, and novel training options are needed and, particularly, new certified practical training sites in REI-ART. The new practical training sites—typically accommodating one to three trainees simultaneously—would be certified on the basis of merit, as described below. One or several training sites would dovetail with a corresponding reference center hence, the bynetwork concept. The reference center would be responsible for delivering the theoretical curriculum and supervising each applicant and his/her thesis project and the affiliated training sites. As illustrated in Figure 2, by-network training is envisioned to rely on the following 3 components: A theoretical curriculum covering the full breadth of knowledge defined by the most stringent available regulators, with two comprehensive initial and final (validation) courses and 11–13 special advanced courses, as illustrated in Figure 1. Hands-on practical training would be offered at certified and supervised training sites participating in the by-network training program. Each participating site would be certified for training a given number of candidates on the basis of in-depth reviews of their clinical activity (volume, span of services, adherence to protocols, and access to data review). Research and thesis—as an important part of REI-ART training—would be conducted under the supervision of a thesis director. The financial model of by-network training still needs to be elaborated. Ideally, the trainee or institution supporting him/her and/or future employers would be responsible for the training fees of the theoretical curriculum. Other models would oversee the practical training, whereby one would expect the trainee to receive some stipend for his/her work as a person in training.
New medical education programs must be conceived from inception with concerns for risk and safety management. Training in REI-ART is no exception. Hence, the fundamentals of safety management—identifying hazards and risks, choosing and positioning defenses, and so on—must be integrated into the training curriculum (1). Ultimately, therefore, the REI-ART training programs must be conceived with a ‘‘safety inside’’ spirit. As addressed below, we foresee an increasing use of simulation as an adjunct to both the theoretical and practical parts of training.
FIGURE 2
International Integration Differences in REI-ART practices across the world primarily stem from divergent payment modalities, regulatory rulings, and ethical bans. Aviation may again be instructive when trying to integrate worldwide REI-ART practice standards. Indeed, the International Civil Aviation Organization (ICAO)—a UN-dependent structure laid out in 1944—develops the Standards and Recommended Practices (SARPs) for guiding national regulators in adopting SARP-compatible laws locally. This again leaves medicine far behind. One should stress therefore that the international societies representing gynecologists and urologists look at ICAO's role in aviation and strive to similarly standardize infertility-ART management worldwide.
BY-SIMULATION IN REI-ART Problem Statement By-simulation training is a novel education strategy gaining interest in medicine, which may progressively complement the efficacy of initial and continuing training courses. Generally, the efficacy of by-simulation training has not been demonstrated beyond an elementary introduction to certain procedures. Yet REI-ART may be a test case for expanding by-simulation training because the large databases resulting from the obligation of reporting outcomes are unique sources of realistic training scenarios.
Simulation in Aviation and Medicine
New REI-ART training option featuring a by-network regrouping and theory, certified practical training sites, and supervising training center. de Ziegler. Training in REI-ART. Fertil Steril 2015.
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Aviation relies extensively on by-simulation training. The public knows about flight simulators—boxes moving on long telescopic legs—that are used for training airline pilots. Their various applications are less known, however. In aviation, simulators serve for the following: Simulating flying at a lower cost than a modern jetliner. Simulating flying conditions that are too uncommon for anyone to be competent at handling them. Without flight simulators it would be impossible—and dangerous—to train pilots to competently handle extreme scenarios. It is, for example, evident that training for ‘‘engine-out situations while landing, in adverse meteorological conditions at night’’ could not be done. In medicine, the distinction between the above two functions of simulation is less clear. This is because teaching of new technical skills—the ‘‘flying’’—and the handling of rare 5
VIEWS AND REVIEWS occurrences—the ‘‘engine-out’’—commonly rely on different supports. Technical devices—the medical simulators—typically serve the former, while the latter mainly rely on scenario-type models. One day however, with larger uses of virtual world systems, we foresee that the better use of simulation in medicine will ultimately, like in aviation, nurture competence at handling the rare and unexpected. In aviation, a flight is successful if it takes off and lands without incident; ART is successful only if the procedure results in a successful birth. It should be as unacceptable for training to have an impact on ART success if simulation is available.
Medical Simulators Medical simulators—technical devices—have been designed for training doctors more rapidly and efficiently to perform certain procedures, such as, for example, laparoscopies (20, 21) or coloscopies (22). In both instances, the simulators helped transfer the skills required for performing these procedures to novices (20, 22). Simulation for teaching doctors how to perform obstetrical ultrasounds led to similar conclusions, showing that beginners quickly approached near-expert levels at performing normal ultrasounds (23). However, the usefulness of these approaches in advanced training is so far less clear. This discrepancy suggests that medical simulators mainly reproduce the normal flying, but not yet the improbable engine-out type situation.
Scenario-based Training Scenario-based training is a nontechnological—narrativedependent—method for simulating uncommon and rarely occurring clinical situations. Aimed at teaching safety reflexes for optimizing clinical management, they are currently targeted at the initial training stages (24). The primary challenge for further expanding the scenario-based by-simulation training in medicine is to be able to feed these systems with complex yet highly realistic clinical scripts. Here the very large ART databases established in parallel with obligatory ART reporting offer unique opportunities. Indeed, ART databases are untapped mines for scenarios of uncommon clinical occurrences of real world incidents otherwise altered when retrieved from memory only (25, 26).
Dyad or in Pairs Simulation-based Training Dyad or in-pairs type training is a way to improve the efficiency and reduce the time and cost of by-simulation programs by teaching two trainees at a time (27, 28). A dyad approach should be developed and tested for improving the training of REI-ART fellows at performing ETs.
Virtual Worlds Virtual worlds are rapidly becoming part of the educational landscape (29). Second Life (SL)—one of the best known of these environments (29)—offers a virtual hospital support for training health-related activities and improving real life behaviors (30). In a 1-hour SL-based interactive course on type 6
2 diabetes management (29), the participants improved their ability at selecting the initial insulin dose and conducting further adjustments. Here again, simulation is so far used for the very initial stages of training. We are not aware of any virtual reality program for REI-ART targeted at physicians, paramedical personnel, or patients. Certain models may soon exist, however, considering the amazingly rapid expansion and immense possibilities of virtual world–based education and smart game–type products.
Simulated ET One training deficiency that is documented as undermining many American REI-ART fellowships, and in turn the clinical care offered by those individuals, is the insufficient ET experience gained during the fellowship. Too many fellows finish their 3-year training without having done enough—at times, even none—actual ETs. This deficiency is commonly justified by indicating that it is improper to let untrained fellows do ETs in patients who pay for their treatments. While the argument may appear reasonable at first glance, actually it is not. Indeed there are many other industries where similar dilemmas have been dealt with to everyone's satisfaction. Using by-simulation and intelligent training modules, it is indeed possible to ascertain that trainees—in this case, REI-ART fellows—have become proficient at doing certain common tasks, for example, ETs, even before having performed an actual live procedure. In a recent publication, Lopez et al. used a cumulative summation (CUSUM) approach—originally developed in industry—for assessing the time taken for asserting competence (31). Using this approach, the authors determined that the five trainees became proficient at doing ET by procedure 15 at the latest (after procedure 15, 9, 7, 13 and 9) (31). Importantly, the pregnancy rates were lower when trainees had between-ET intervals of R10 days, as compared with
