The Development of an International Oncofertility Competency Framework: A Model to Increase Oncofertility Implementation.

BACKGROUND: Despite international evidence about fertility preservation (FP), several barriers still prevent the implementation of equitable FP practice. Currently, oncofertility competencies do not exist. The aim of this study was to develop an oncofertility competency framework that defines the key components of oncofertility care, develops a model for prioritizing service development, and defines the roles that health care professionals (HCPs) play. MATERIALS AND METHOD: A quantitative modified Delphi methodology was used to conduct two rounds of an electronic survey, querying and synthesizing opinions about statements regarding oncofertility care with HCPs and patient and family advocacy groups (PFAs) from 16 countries (12 high and 4 middle income). Statements included the roles of HCPs and priorities for service development care across ten domains (communication, oncofertility decision aids, age-appropriate care, referral pathways, documentation, oncofertility training, reproductive survivorship care and fertility-related psychosocial support, supportive care, and ethical frameworks) that represent 33 different elements of care. RESULTS: The first questionnaire was completed by 457 participants (332 HCPs and 125 PFAs). One hundred and thirty-eight participants completed the second questionnaire (122 HCPs and 16 PFAs). Consensus was agreed on 108 oncofertility competencies and the roles HCPs should play in oncofertility care. A three-tier service development model is proposed, with gradual implementation of different components of care. A total of 92.8% of the 108 agreed competencies also had agreement between high and middle income participants. CONCLUSION: FP guidelines establish best practice but do not consider the skills and requirements to implement these guidelines. The competency framework gives HCPs and services a structure for the training of HCPs and implementation of care, as well as defining a model for prioritizing oncofertility service development. IMPLICATIONS FOR PRACTICE: Despite international evidence about fertility preservation (FP), several barriers still prevent the implementation of equitable FP practice. The competency framework gives 108 competencies that will allow health care professionals (HCPs) and services a structure for the development of oncofertility care, as well as define the role HCPs play to provide care and support. The framework also proposes a three-tier oncofertility service development model which prioritizes the development of components of oncofertility care into essential, enhanced, and expert services, giving clear recommendations for service development. The competency framework will enhance the implementation of FP guidelines, improving the equitable access to medical and psychological oncofertility care.

Beyond the dichotomy: a tool for distinguishing between experimental, innovative and established treatment.

STUDY QUESTION: The precise delineation of the research phase is a recurrent subject of debate: When is the evidence base firm enough to decide that a new technology or treatment no longer needs to be regarded as 'experimental'? SUMMARY ANSWER: We propose a framework that distinguishes between three instead of two types of treatment and describes a continuum from experimental over innovative to established treatment, offering a tool meant to facilitate decision-making about the introduction of new technologies in the clinic. WHAT IS KNOWN ALREADY: Traditionally, guidelines from medical societies on the notion of 'experimental treatment' depart from a dichotomy between experimental and established treatment. However, in the field of reproductive medicine, there are several problems with a dichotomous framework. First, it does not offer an adequate account of the reality in the clinic. Secondly, this view may bring about several negative effects for the patient, such as techniques being considered established too early, holding risks unknown to patients. A further drawback of the dichotomy is that if a technique is no longer considered experimental, centres offering the technique may no longer consider it useful gathering and critically examining (follow-up) data. STUDY DESIGN, SIZE, DURATION: The framework and scoring tool were developed over several phases during which the authors operated as a consensus group of experts. PARTICIPANTS/MATERIALS, SETTING, METHODS: The scoring tool reflects the continuous progression of a new procedure from experimental through innovative to established. For this evolution, four criteria were considered relevant. The first (efficacy) is a categorical criterion (pass/fail). The other three criteria (safety, procedural reliability and transparency and effectiveness) are ordinal in nature. Thresholds have been introduced for all four criteria to avoid that a technology scoring high on procedure and effectiveness but extremely low on safety could move to the next level because of a sufficiently high overall score. MAIN RESULTS AND THE ROLE OF CHANCE: Only treatments that are rated above the thresholds for all four criteria could be considered at least innovative treatments. When they score 4 or higher on the last three criteria, they are considered established treatments. LIMITATIONS, REASONS FOR CAUTION: Knowledge about the procedures or techniques under discussion is essential in order to use the tool. WIDER IMPLICATIONS OF THE FINDINGS: The tool is designed to be used on a macro-level (e.g. by professional societies) although it could also be valuable in the local setting. Both the framework and the tool can bring more clarity on the notion of 'experimental treatment', especially with regard to how to decide when a specific technology or treatment falls in this category and when it can move into one of the other categories. STUDY FUNDING/COMPETING INTEREST(S): none. TRIAL REGISTRATION NUMBER: none.

Current issues in medically assisted reproduction and genetics in Europe: research, clinical practice, ethics, legal issues and policy.

STUDY QUESTION: How has the interface between genetics and assisted reproduction technology (ART) evolved since 2005? SUMMARY ANSWER: The interface between ART and genetics has become more entwined as we increase our understanding about the genetics of infertility and we are able to perform more comprehensive genetic testing. WHAT IS KNOWN ALREADY: In March 2005, a group of experts from the European Society of Human Genetics and European Society of Human Reproduction and Embryology met to discuss the interface between genetics and ART and published an extended background paper, recommendations and two Editorials. STUDY DESIGN, SIZE, DURATION: An interdisciplinary workshop was held, involving representatives of both professional societies and experts from the European Union Eurogentest2 Coordination Action Project. PARTICIPANTS/MATERIALS, SETTING, METHODS: In March 2012, a group of experts from the European Society of Human Genetics, the European Society of Human Reproduction and Embryology and the EuroGentest2 Coordination Action Project met to discuss developments at the interface between clinical genetics and ART. MAIN RESULTS AND THE ROLE OF CHANCE: As more genetic causes of reproductive failure are now recognized and an increasing number of patients undergo testing of their genome prior to conception, either in regular health care or in the context of direct-to-consumer testing, the need for genetic counselling and PGD may increase. Preimplantation genetic screening (PGS) thus far does not have evidence from RCTs to substantiate that the technique is both effective and efficient. Whole genome sequencing may create greater challenges both in the technological and interpretational domains, and requires further reflection about the ethics of genetic testing in ART and PGD/PGS. Diagnostic laboratories should be reporting their results according to internationally accepted accreditation standards (ISO 15189). Further studies are needed in order to address issues related to the impact of ART on epigenetic reprogramming of the early embryo. LIMITATIONS, REASONS FOR CAUTION: The legal landscape regarding assisted reproduction is evolving, but still remains very heterogeneous and often contradictory. The lack of legal harmonization and uneven access to infertility treatment and PGD/PGS fosters considerable cross-border reproductive care in Europe, and beyond. WIDER IMPLICATIONS OF THE FINDINGS: This continually evolving field requires communication between the clinical genetics and IVF teams and patients to ensure that they are fully informed and can make well-considered choices. STUDY FUNDING/COMPETING INTERESTS: Funding was received from ESHRE, ESHG and EuroGentest2 European Union Coordination Action project (FP7 - HEALTH-F4-2010-26146) to support attendance at this meeting.

[A comparison of reproductive rights in Europe: a right to reproduce?]. / Droit comparé en santé de la reproduction: un droit a se reproduire? Une vision européenne.

This article discusses the meaning of reproductive rights, and European attitudes to this issue, from both the ethical and legal standpoints. There is a difference in the international nomenclature between "reproductive rights "and a "right to reproduce", which translates in medical practice into a right to fertility treatment. Major national differences are outlined, particularly between France and the UK. Finally, the new phenomenon of cross-border reproductive care, a direct consequence of different national interpretations of reproductive rights, is discussed.

Implementing a good practice guide for CBRC: perspectives from the ESHRE Cross-Border Reproductive Care Taskforce.

This article sets out views about cross-border reproductive care (CBRC) from the point of view of a professional clinicians' group. After publishing the first international European dataset measuring the phenomenon of CBRC in six European countries in June 2010, the European Society for Human Reproduction and Embryology (ESHRE) Taskforce on CBRC set out to write a good practice guide, which aims at advising clinicians and professionals dealing with patients interested in seeking fertility treatment outside their country of residence. The background, outline and possible means of implementation of this guide are discussed here. The aims of the guide are to ensure quality of care and safety for all concerned, from patients to their future offspring, via gamete donors and surrogates if involved. Patient centredness is also an important aspect, as well as fair treatment of all parties, based on appropriate and intelligible information.

EBCOG position statement on "Ethical analysis of cross-border reproductive care".

Cross border movement of couples to seek assisted conception treatments which are not available in their own countries are creating lots of ethical issues. Eu countires should work together to deliver couple centered care within a legal framework.

Globalised quests for assisted conception: Reproductive travel for infertility and involuntary childlessness.

The global movement of people across international borders to undergo assisted reproductive treatment is common, although there is little accurate data. In this article, we synthesise findings from our own empirical research on reproductive travel in addition to a review of clinical, ethical, legal, and regulatory complexities from studies on reproductive travel since 2010. Motivations for travel include legal and religious prohibitions; resource considerations; lack of access to gametes and reproductive assistors; quality and safety concerns; and personal preferences. Higher risks to mothers and children are associated with multiple embryo transfer and subsequent multiple and higher order pregnancies and the average older age of women undertaking reproductive travel. The potential exploitation of other women as providers of oocytes or surrogacy services, the lack of equity in access to assisted reproduction and the ambiguous legal status of children conceived from international reproductive travel are important ethical considerations. A range of significant legal issues remain given variable and limited international regulation. Scholarship on this trade necessarily engages with issues of power and gender, social inequities, global capitalism and the private decision-making of individuals seeking to form families. Research gaps remain given recent changes in the organisation, demands and destinations of the trade.

How can we improve oncofertility care for patients? A systematic scoping review of current international practice and models of care.

BACKGROUND: Fertility preservation (FP) is an important quality of life issue for cancer survivors of reproductive age. Despite the existence of broad international guidelines, the delivery of oncofertility care, particularly amongst paediatric, adolescent and young adult patients, remains a challenge for healthcare professionals (HCPs). The quality of oncofertility care is variable and the uptake and utilization of FP remains low. Available guidelines fall short in providing adequate detail on how oncofertility models of care (MOC) allow for the real-world application of guidelines by HCPs. OBJECTIVE AND RATIONALE: The aim of this study was to systematically review the literature on the components of oncofertility care as defined by patient and clinician representatives, and identify the barriers, facilitators and challenges, so as to improve the implementation of oncofertility services. SEARCH METHODS: A systematic scoping review was conducted on oncofertility MOC literature published in English between 2007 and 2016, relating to 10 domains of care identified through consumer research: communication, oncofertility decision aids, age-appropriate care, referral pathways, documentation, training, supportive care during treatment, reproductive care after cancer treatment, psychosocial support and ethical practice of oncofertility care. A wide range of electronic databases (CINAHL, Embase, PsycINFO, PubMed, AEIPT, Education Research Complete, ProQuest and VOCED) were searched in order to synthesize the evidence around delivery of oncofertility care. Related citations and reference lists were searched. The review was undertaken following registration (International prospective register of systematic reviews (PROSPERO) registration number CRD42017055837) and guidelines of Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). OUTCOMES: A total of 846 potentially relevant studies were identified after the removal of duplicates. All titles and abstracts were screened by a single reviewer and the final 147 papers were screened by two reviewers. Ten papers on established MOC were identified amongst the included papers. Data were extracted from each paper and quality scores were then summarized in the oncofertility MOC summary matrix. The results identified a number of themes for improving MOC in each domain, which included: the importance of patients receiving communication that is of a higher quality and in different formats on their fertility risk and FP options; improving provision of oncofertility care in a timely manner; improving access to age-appropriate care; defining the role and scope of practice of all HCPs; and improving communication between different HCPs. Different forms of decision aids were found useful for assisting patients to understand FP options and weigh up choices. WIDER IMPLICATIONS: This analysis identifies core components for delivery of oncofertility MOC. The provision of oncofertility services requires planning to ensure services have safe and reliable referral pathways and that they are age-appropriate and include medical and psychological oncofertility care into the survivorship period. In order for this to happen, collaboration needs to occur between clinicians, allied HCPs and executives within paediatric and adult hospitals, as well as fertility clinics across both public and private services. Training of both cancer and non-cancer HCPs is needed to improve the knowledge of HCPs, the quality of care provided and the confidence of HCPs with these consultations.

Current issues in medically assisted reproduction and genetics in Europe: research, clinical practice, ethics, legal issues and policy. European Society of Human Genetics and European Society of Human Reproduction and Embryology.

In March 2005, a group of experts from the European Society of Human Genetics and European Society of Human Reproduction and Embryology met to discuss the interface between genetics and assisted reproductive technology (ART), and published an extended background paper, recommendations and two Editorials. Seven years later, in March 2012, a follow-up interdisciplinary workshop was held, involving representatives of both professional societies, including experts from the European Union Eurogentest2 Coordination Action Project. The main goal of this meeting was to discuss developments at the interface between clinical genetics and ARTs. As more genetic causes of reproductive failure are now recognised and an increasing number of patients undergo testing of their genome before conception, either in regular health care or in the context of direct-to-consumer testing, the need for genetic counselling and preimplantation genetic diagnosis (PGD) may increase. Preimplantation genetic screening (PGS) thus far does not have evidence from randomised clinical trials to substantiate that the technique is both effective and efficient. Whole-genome sequencing may create greater challenges both in the technological and interpretational domains, and requires further reflection about the ethics of genetic testing in ART and PGD/PGS. Diagnostic laboratories should be reporting their results according to internationally accepted accreditation standards (International Standards Organisation - ISO 15189). Further studies are needed in order to address issues related to the impact of ART on epigenetic reprogramming of the early embryo. The legal landscape regarding assisted reproduction is evolving but still remains very heterogeneous and often contradictory. The lack of legal harmonisation and uneven access to infertility treatment and PGD/PGS fosters considerable cross-border reproductive care in Europe and beyond. The aim of this paper is to complement previous publications and provide an update of selected topics that have evolved since 2005.

Giving oocytes to women in need: permitted, forbidden, or pressured? A commentary.

There can be no starker contrast in egg donation than between Austria, where it is forbidden, and Israel, where it is encouraged to the extent that some Israeli women go abroad in order to obtain these precious reproductive cells. There are grave ethical issues in some of the transactions involved, which may fall out with the definition of a gift. The ESHRE taskforce on cross-border reproductive care is keen to promote standards in this field, including the ethical standard of avoiding coercion.This is a commentary on http://www.ijhpr.org/content/1/1/15/

Procreative liberty, or collective responsibility? Comment on the House of Commons report Human Reproductive Technologies and the Law, and on Dahl's response.

The matter of social sex selection is of universal interest. It is argued that it is so important that an insular response by the select committee on the subject must be replaced by one founded on an international human rights stance, in which light sex selection may only be seen as sexist per se.

Gamete donation: ethical implications for donors.

The interests of gamete donors have only recently been recognized in assisted reproduction; traditionally, the interests of the patients (typically a couple) and the prospective child are paramount. However, assisted reproduction would not be possible without donors, and the simple utilitarian view would be to place their interests first to maximize the availability of the practice. There are several ethical issues on both sides of the donor--recipient equation, some of which are mutual and others are in conflict. For example, the word 'donation' implies there is no payment. Informed consent for donation is essential if the autonomy of the donor is to be respected, and includes information about the results of screening. This is a sensitive issue, especially when pathology is found in a donor who is not being screened for his or her own immediate benefit. Counselling may result in donors refusing to take part, but may also lead to selection by the person recruiting the donors, sometimes as a consequence of examining the motivation of the donor. In this case, the main problem is the ethical basis of the selection process. Other aspects of gamete donation may lead to a conflict of interests between the donor, the recipients and even the prospective child, particularly in terms of anonymity and the information that is made available about the specific circumstances of donation. Implications and support counselling are essential tools in achieving an acceptable balance for all parties involved.