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Accelerating innovation translation is a priority for improving healthcare and health. Although dissemination and implementation (D&I) research has made significant advances over the past decade, it has attended primarily to the implementation of long-standing, well-established practices and policies. We present a conceptual architecture for speeding translation of promising innovations as candidates for iterative testing in practice. Our framework to Design for Accelerated Translation (DART) aims to clarify whether, when, and how to act on evolving evidence to improve healthcare. We view translation of evidence to practice as a dynamic process and argue that much evidence can be acted upon even when uncertainty is moderately high, recognizing that this evidence is evolving and subject to frequent reevaluation. The DART framework proposes that additional factors – demand, risk, and cost, in addition to the evolving evidence base – should influence the pace of translation over time. Attention to these underemphasized factors may lead to more dynamic decision-making about whether or not to adopt an emerging innovation or de-implement a suboptimal intervention. Finally, the DART framework outlines key actions that will speed movement from evidence to practice, including forming meaningful stakeholder partnerships, designing innovations for D&I, and engaging in a learning health system.
Nation-specific registries of ART treatments were established in the United States, Canada, and Mexico in 1985, 1999 and 1995 respectively. In the United States, reporting became mandatory in 1992, and 94% of nearly the 500 clinics report. In Canada, reporting is voluntary and all but one clinic is currently reporting. In Mexico, a small proportion (about 20%) of over 50 clinics report to their country’s registry. Initially these registries contained summaries of each clinic’s overall outcomes, but all have now become cycle-specific. While all registries have systems in place to ensure quality of data, prospective reporting and annual data validations are mandatory only in the United States. All registries have adjusted their online data collections systems to capture changes in clinical practice patterns. Clinic-specific ART reports are available online in all North American countries. Information from these registries has been valuable for research and to develop treatment guidelines; most significantly, guidelines regarding the number of embryos to transfer has led to a dramatic reduction in multiple pregnancy rates.
In many areas activities in assisted reproductive technology (ART) are being recorded and analyzed by registries, either on a voluntary or compulsory basis , and reports are generated producing cross-sectional data on an annual basis. Current ART is now developing towards a segmented longitudinal approach, in which single therapeutic steps are spread over prolonged time intervals, necessitating a cumulative approach in the handling of ART-data. This requires a unique identifier for each individual seeking fertility care together with an informed and signed consent. The identifier should reside with the institution offering fertility treatment and follow the infertile individual through the various therapeutic steps, even if leaving to another institution. The identifier should be added to all data submitted to the ART registry. This will allow the national health register to construct cumulative outcome data on all forms of fertility treatment, including long-term gamete and tissue freezing-related information.
Although, IUI is one of the most frequently used fertility treatments worldwide insemination with and without ovarian stimulation and cycle-monitoring (timed intercourse) are only included in very few large national and international data collections on ART monitoring. . IUI is easy accessible, low tech, cheap and patient friendly and is efficient in the treatment of unexplained infertility and mild to moderate male factor infertility. Yet, another indication for IUI is in addition to ovulation induction in women with anovulatory infertility. The European IVF-Monitoring Consortium (EIM), an institution of the European Society of Human Reproduction and Embryology (ESHRE) has collected data on IUI since 1997.
This chapter comprises a definition of MAR and an overview of the worldwide current MAR monitoring. Moreover, we discuss the importance of including MAR and IUI in the ART monitoring programs to assess the full quality and safety of fertility treatments.
Safety of medical treatments implies all their side and long-term effects on patients. With reference to ART, subjects involved are mothers and their children.
Since the early application of IVF, operators have agreed on the importance of monitoring these new techniques in order to build and maintain trust towards them.
Collecting data regarding assisted reproduction techniques worldwide is of the utmost usefulness to ensure safety and quality of treatments provided, to detect potential problems, as well as to implement practices aimed at reducing risks and improving outcomes.
Nowadays, well-functioning registries have been set up in most countries. Regulations and guidelines for the monitoring of all clinical and laboratory aspects of assisted reproduction techniques have been issued, also based on data collected so far.
Currently available evidence should be the basis for a further improvement of medical and laboratory practices.
After the first successes of ART, this technique showed a rapid development, in many countries. It soon appeared to the professionals themselves that a number of important health concerns were related to the new technique, in terms of practice, efficacy and safety. Moreover, the competition between centers requested solid data for the public and health authorities correct knowledge, based on large samples. This resulted in the development of national, regional, and world registries. It needed general agreements on definitions, numerators, denominators, ways of reporting, that were obtained through several workshops that included WHO. This chapter outlines, in a first section, general importance of surveillance, on efficacy, and safety (immediate and long term, women and children). The second section describes the history itself, from national to regional and world (ICMART) registries. It shows that a lot has already been done, even if efforts are still needed to improve quality, but it is better to have insufficient knowledge than none at all.
In 1790, John Hunter a Scottish surgeon and one of the most distinguished scientists at that time wrote the first report on artificial insemination in medical literature about a cloth merchant with severe hypospadias, who collected his semen escaping during coitus in a warmed syringe and inject this sample into the vagina.
Intrauterine insemination (IUI) is not included in the definition of assisted reproductive technology (ART) as ART comprises techniques, where oocytes are cultured in-vitro, but IUI is included in the definition of Medically Assisted Reproduction (MAR).
The International Committee Monitoring Assisted Reproductive Technologies (ICMART) has reported global ART results, helped create and improve national and regional registries, and promoted standardization of international terminology through development and revision of glossaries. These accomplishments have required the dedication and expertise of many professionals over several decades. ICMART’s history is instructive for those developing or improving their own registries. Creation of a formal structure is essential to success and sustainability of a registry. Development of relationships and formal partnerships hastens progress and benefits all stakeholders. The initial development of the glossary involved the World Health Organization (WHO). The third revision has the participation of essentially all major global stakeholders. Registries have significant value for professionals, patients and policy makers. ICMART’s registry reports utilization, profile of procedures and patients, effectiveness and safety. Despite much progress, many data collection and reporting difficulties remain. However, collaboration in addressing these challenges is resulting in major progress and also bringing many collateral benefits, especially enhanced professional relationships and harmonized approaches to problems. The future will see more comprehensive and higher quality registries, harmonized data collection, the use of “big data” analytics and artificial intelligence to increase the value of registries for patient care, research, public education and policy makers.
ART was pioneered in Africa in the 1980’s. Subsequently, ART centres emerged around the continent, mostly by specialists acquiring skills abroad. Despite this, ART activity remains scant in most African countries and absent in several others.
Historically, ART surveillance in Africa has been similarly scant and fragmented. Recently however, the African Network and Registry for ART (ANARA) has been established with the vision to reduce the high burden of infertility in Africa through ART; and its mission to bring together ART centres within and across countries and to collect data pertaining to availability, utilization, effectiveness and safety of ART. First registry data, collected from 40 centres in 13 countries, and will be published shortly. ANARA protects the anonymity of centres and patients and the ownership of data.
The successful establishment of ANARA is rooted in a collaborative spirit of engagement with ART centres and other stakeholders, developmental assistance from both the Latin American and World Registry, and the importance of data in reducing the burden of infertility in Africa.
Asia is composed of more than 40 countries where about 60% of the global population live. Since Asia is the largest and geographically variable continent, where cultural and social backgrounds are very diverse in every part of this area, it is almost impossible to describe the whole area in one chapter. Rapid decline of birth rates in multiple countries, particularly in eastern Asia, drew wide public attention and promoted the treatment and care for infertile couples. Particularly, assisted reproductive technology (ART) has significantly spread in many Asian countries and its growth is still ongoing. Although ART registries were established in several Asian countries many years ago, there is no Asian regional registry because of this diverse situation of this area.
While many countries recognize the importance of collecting and using ART data, ART surveillance systems and other ART data collection tools, such as registries or repositories, vary according to ownership, reporting responsibility, type of data being reported, information being reported, data quality and validation activities, public reporting of success rates, reporting requirements, and data protection around the world. However, there is a need for ART surveillance systems to be simple, flexible, acceptable, representative, timely, and stable as well as to have high data quality, sensitivity, and positive predictive values. This chapter will explore each of these areas as they relate to ART surveillance.
Infertility affects an estimated 80 million individuals worldwide, or 10–15% of couples of reproductive age. The number of assisted reproductive technology (ART) cycles in the United States more than doubled between 2000 and 2013. In 2015, about 1.7% of all live births in the United States were the result of this technology. In the US, studies of the long-term outcomes of ART involve the challenge of linking databases, in which one database has information on the treatment parameters, and the other database captures the outcomes of interest. This chapter discusses the linkage efforts, methodologies, and resulting research in the US by the Society for Assisted Reproductive Technology (SART) and the Centers for Disease Control and Prevention (CDC), and the health linkages routinely performed in the Nordic countries. Strengths and limitations of these approaches are also discussed.
Surveillance is an international project that was undertaken by the International Federation of Fertility Societies (IFFS) in 1998 to document current practices and trends pertaining to the Assisted Reproductive Technology (ART) in countries performing ART services. Data are compiled from responses submitted to a triennial online questionnaire from unpaid volunteer representatives from the participating countries. Eight editions have been published which have reflected a wide range of methods for recording and reporting data and ensuring oversight. The successive editions have noted trends including an increase in the volume of services provided and broader acceptance and access to ART services.