title: Top 10 priorities for future infertility research: an international consensus development study†  ‡.

authors: Duffy, J.M.N.

subjects: Consensus science methods

abstract: STUDY QUESTION: Can the priorities for future research in infertility be identified? 
SUMMARY ANSWER: The top 10 research priorities for the four areas of male infertility, female and unexplained infertility, medically assisted reproduction and ethics, access and organization of care for people with fertility problems were identified. 
WHAT IS KNOWN ALREADY: Many fundamental questions regarding the prevention, management and consequences of infertility remain unanswered. This is a barrier to improving the care received by those people with fertility problems. 
STUDY DESIGN, SIZE, DURATION: Potential research questions were collated from an initial international survey, a systematic review of clinical practice guidelines and Cochrane systematic reviews. A rationalized list of confirmed research uncertainties was prioritized in an interim international survey. Prioritized research uncertainties were discussed during a consensus development meeting. Using a formal consensus development method, the modified nominal group technique, diverse stakeholders identified the top 10 research priorities for each of the categories male infertility, female and unexplained infertility, medically assisted reproduction and ethics, access and organization of care. 
PARTICIPANTS/MATERIALS, SETTING, METHODS: Healthcare professionals, people with fertility problems and others (healthcare funders, healthcare providers, healthcare regulators, research funding bodies and researchers) were brought together in an open and transparent process using formal consensus methods advocated by the James Lind Alliance. 
MAIN RESULTS AND THE ROLE OF CHANCE: The initial survey was completed by 388 participants from 40 countries, and 423 potential research questions were submitted. Fourteen clinical practice guidelines and 162 Cochrane systematic reviews identified a further 236 potential research questions. A rationalized list of 231 confirmed research uncertainties was entered into an interim prioritization survey completed by 317 respondents from 43 countries. The top 10 research priorities for each of the four categories male infertility, female and unexplained infertility (including age-related infertility, ovarian cysts, uterine cavity abnormalities and tubal factor infertility), medically assisted reproduction (including ovarian stimulation, IUI and IVF) and ethics, access and organization of care were identified during a consensus development meeting involving 41 participants from 11 countries. These research priorities were diverse and seek answers to questions regarding prevention, treatment and the longer-term impact of infertility. They highlight the importance of pursuing research which has often been overlooked, including addressing the emotional and psychological impact of infertility, improving access to fertility treatment, particularly in lower resource settings and securing appropriate regulation. Addressing these priorities will require diverse research methodologies, including laboratory-based science, qualitative and quantitative research and population science. 
LIMITATIONS, REASONS FOR CAUTION: We used consensus development methods, which have inherent limitations, including the representativeness of the participant sample, methodological decisions informed by professional judgment and arbitrary consensus definitions. 
WIDER IMPLICATIONS OF THE FINDINGS: We anticipate that identified research priorities, developed to specifically highlight the most pressing clinical needs as perceived by healthcare professionals, people with fertility problems and others, will help research funding organizations and researchers to develop their future research agenda. 
STUDY FUNDING/COMPETING INTEREST(S): The study was funded by the Auckland Medical Research Foundation, Catalyst Fund, Royal Society of New Zealand and Maurice and Phyllis Paykel Trust. G.D.A. reports research sponsorship from Abbott, personal fees from Abbott and LabCorp, a financial interest in Advanced Reproductive Care, committee membership of the FIGO Committee on Reproductive Medicine, International Committee for Monitoring Assisted Reproductive Technologies, International Federation of Fertility Societies and World Endometriosis Research Foundation, and research sponsorship of the International Committee for Monitoring Assisted Reproductive Technologies from Abbott and Ferring. Siladitya Bhattacharya reports being the Editor-in-Chief of Human Reproduction Open and editor for the Cochrane Gynaecology and Fertility Group. J.L.H.E. reports being the Editor Emeritus of Human Reproduction. A.W.H. reports research sponsorship from the Chief Scientist's Office, Ferring, Medical Research Council, National Institute for Health Research and Wellbeing of Women and consultancy fees from AbbVie, Ferring, Nordic Pharma and Roche Diagnostics. M.L.H. reports grants from Merck, grants from Myovant, grants from Bayer, outside the submitted work and ownership in Embrace Fertility, a private fertility company. N.P.J. reports research sponsorship from AbbVie and Myovant Sciences and consultancy fees from Guerbet, Myovant Sciences, Roche Diagnostics and Vifor Pharma. J.M.L.K. reports research sponsorship from Ferring and Theramex. R.S.L. reports consultancy fees from AbbVie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. B.W.M. reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. E.H.Y.N. reports research sponsorship from Merck. C.N. reports being the Co Editor-in-Chief of Fertility and Sterility and Section Editor of the Journal of Urology, research sponsorship from Ferring and retains a financial interest in NexHand. J.S. reports being employed by a National Health Service fertility clinic, consultancy fees from Merck for educational events, sponsorship to attend a fertility conference from Ferring and being a clinical subeditor of Human Fertility. A.S. reports consultancy fees from Guerbet. J.W. reports being a statistical editor for the Cochrane Gynaecology and Fertility Group. A.V. reports that he is a Statistical Editor of the Cochrane Gynaecology & Fertility Review Group and the journal Reproduction. His employing institution has received payment from Human Fertilisation and Embryology Authority for his advice on review of research evidence to inform their 'traffic light' system for infertility treatment 'add-ons'. N.L.V. reports consultancy and conference fees from Ferring, Merck and Merck Sharp and Dohme. The remaining authors declare no competing interests in relation to the present work. All authors have completed the disclosure form. 
TRIAL REGISTRATION NUMBER: N/A.

text: Top 10 priorities for future infertility research: an international consensus development study†  ‡. STUDY QUESTION: Can the priorities for future research in infertility be identified? 
SUMMARY ANSWER: The top 10 research priorities for the four areas of male infertility, female and unexplained infertility, medically assisted reproduction and ethics, access and organization of care for people with fertility problems were identified. 
WHAT IS KNOWN ALREADY: Many fundamental questions regarding the prevention, management and consequences of infertility remain unanswered. This is a barrier to improving the care received by those people with fertility problems. 
STUDY DESIGN, SIZE, DURATION: Potential research questions were collated from an initial international survey, a systematic review of clinical practice guidelines and Cochrane systematic reviews. A rationalized list of confirmed research uncertainties was prioritized in an interim international survey. Prioritized research uncertainties were discussed during a consensus development meeting. Using a formal consensus development method, the modified nominal group technique, diverse stakeholders identified the top 10 research priorities for each of the categories male infertility, female and unexplained infertility, medically assisted reproduction and ethics, access and organization of care. 
PARTICIPANTS/MATERIALS, SETTING, METHODS: Healthcare professionals, people with fertility problems and others (healthcare funders, healthcare providers, healthcare regulators, research funding bodies and researchers) were brought together in an open and transparent process using formal consensus methods advocated by the James Lind Alliance. 
MAIN RESULTS AND THE ROLE OF CHANCE: The initial survey was completed by 388 participants from 40 countries, and 423 potential research questions were submitted. Fourteen clinical practice guidelines and 162 Cochrane systematic reviews identified a further 236 potential research questions. A rationalized list of 231 confirmed research uncertainties was entered into an interim prioritization survey completed by 317 respondents from 43 countries. The top 10 research priorities for each of the four categories male infertility, female and unexplained infertility (including age-related infertility, ovarian cysts, uterine cavity abnormalities and tubal factor infertility), medically assisted reproduction (including ovarian stimulation, IUI and IVF) and ethics, access and organization of care were identified during a consensus development meeting involving 41 participants from 11 countries. These research priorities were diverse and seek answers to questions regarding prevention, treatment and the longer-term impact of infertility. They highlight the importance of pursuing research which has often been overlooked, including addressing the emotional and psychological impact of infertility, improving access to fertility treatment, particularly in lower resource settings and securing appropriate regulation. Addressing these priorities will require diverse research methodologies, including laboratory-based science, qualitative and quantitative research and population science. 
LIMITATIONS, REASONS FOR CAUTION: We used consensus development methods, which have inherent limitations, including the representativeness of the participant sample, methodological decisions informed by professional judgment and arbitrary consensus definitions. 
WIDER IMPLICATIONS OF THE FINDINGS: We anticipate that identified research priorities, developed to specifically highlight the most pressing clinical needs as perceived by healthcare professionals, people with fertility problems and others, will help research funding organizations and researchers to develop their future research agenda. 
STUDY FUNDING/COMPETING INTEREST(S): The study was funded by the Auckland Medical Research Foundation, Catalyst Fund, Royal Society of New Zealand and Maurice and Phyllis Paykel Trust. G.D.A. reports research sponsorship from Abbott, personal fees from Abbott and LabCorp, a financial interest in Advanced Reproductive Care, committee membership of the FIGO Committee on Reproductive Medicine, International Committee for Monitoring Assisted Reproductive Technologies, International Federation of Fertility Societies and World Endometriosis Research Foundation, and research sponsorship of the International Committee for Monitoring Assisted Reproductive Technologies from Abbott and Ferring. Siladitya Bhattacharya reports being the Editor-in-Chief of Human Reproduction Open and editor for the Cochrane Gynaecology and Fertility Group. J.L.H.E. reports being the Editor Emeritus of Human Reproduction. A.W.H. reports research sponsorship from the Chief Scientist's Office, Ferring, Medical Research Council, National Institute for Health Research and Wellbeing of Women and consultancy fees from AbbVie, Ferring, Nordic Pharma and Roche Diagnostics. M.L.H. reports grants from Merck, grants from Myovant, grants from Bayer, outside the submitted work and ownership in Embrace Fertility, a private fertility company. N.P.J. reports research sponsorship from AbbVie and Myovant Sciences and consultancy fees from Guerbet, Myovant Sciences, Roche Diagnostics and Vifor Pharma. J.M.L.K. reports research sponsorship from Ferring and Theramex. R.S.L. reports consultancy fees from AbbVie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. B.W.M. reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. E.H.Y.N. reports research sponsorship from Merck. C.N. reports being the Co Editor-in-Chief of Fertility and Sterility and Section Editor of the Journal of Urology, research sponsorship from Ferring and retains a financial interest in NexHand. J.S. reports being employed by a National Health Service fertility clinic, consultancy fees from Merck for educational events, sponsorship to attend a fertility conference from Ferring and being a clinical subeditor of Human Fertility. A.S. reports consultancy fees from Guerbet. J.W. reports being a statistical editor for the Cochrane Gynaecology and Fertility Group. A.V. reports that he is a Statistical Editor of the Cochrane Gynaecology & Fertility Review Group and the journal Reproduction. His employing institution has received payment from Human Fertilisation and Embryology Authority for his advice on review of research evidence to inform their 'traffic light' system for infertility treatment 'add-ons'. N.L.V. reports consultancy and conference fees from Ferring, Merck and Merck Sharp and Dohme. The remaining authors declare no competing interests in relation to the present work. All authors have completed the disclosure form. 
TRIAL REGISTRATION NUMBER: N/A.

year: 2020-11-30

title: Editorial: The rapid rise of streams and rivers in conservation assessment

authors: Collier, Kevin J.

subjects: stream or river conservation

abstract: The last few years have seen a remarkable rise in the number of publications on stream or river conservation planning or assessment, culminating most recently with a special issue of Freshwater Biology (Figure 1). There is no doubt that conservation planning for lotic systems has come a long way in the last 20 years. When I first delved into this field in the late 1980s, river ecologists were struggling to interpret and apply conservation criteria originally developed for terrestrial systems, and grappling with the seemingly intractable issues of how to deal with complex linear networks, multidimensional connections, and the high temporal and spatial variability of ecosystems with a paucity of biological data. This editorial takes stock of where we are now in terms of river conservation assessment, how we got here from the initial days of conservation criteria, and how far we have come along the journey towards achieving the goal of effective and enduring stream and river conservation. The focus is on developments since 1990 when the inaugural Conservation and Management of Rivers conference in York had a major focus on conservation assessment (Boon et al., 1992).

text: Editorial: The rapid rise of streams and rivers in conservation assessment The last few years have seen a remarkable rise in the number of publications on stream or river conservation planning or assessment, culminating most recently with a special issue of Freshwater Biology (Figure 1). There is no doubt that conservation planning for lotic systems has come a long way in the last 20 years. When I first delved into this field in the late 1980s, river ecologists were struggling to interpret and apply conservation criteria originally developed for terrestrial systems, and grappling with the seemingly intractable issues of how to deal with complex linear networks, multidimensional connections, and the high temporal and spatial variability of ecosystems with a paucity of biological data. This editorial takes stock of where we are now in terms of river conservation assessment, how we got here from the initial days of conservation criteria, and how far we have come along the journey towards achieving the goal of effective and enduring stream and river conservation. The focus is on developments since 1990 when the inaugural Conservation and Management of Rivers conference in York had a major focus on conservation assessment (Boon et al., 1992).

year: 2011

title: A trans-national analysis of equitable utilisation and minimisation of environmental harm under environmental laws at international, federal and national levels

authors: Hasan, Qaraman

subjects: International Environmental Law

abstract: Due to increasing demand for various human needs and climate change issues, rivers are now under enormous pressure. With increasing pressure on these valuable natural resources, responses among state and non-state actors are insufficient in the Anthropocene. To fill the gap, International Environmental Law (IEL) provides several principles for better management of these resources. Equitable utilisation and minimisation of environmental harm are among the most important principles of the IEL. From a theoretical perspective, these principles should lead to the sustainability of these resources and promote cooperation among relevant actors.

However, many river basins are still not allocated equitably and suffer from environmental damage. By using comparative, doctrinal, and empirical research methods, this thesis evaluates the two principles at the international level in Tigris and Euphrates River Basin, the federal level in Murray Darling Basin and at the local level in the Waikato River catchment. The research discovered major challenges for implementing the two principles. One major challenge is sovereignty, another is a lack or weakness of local voices and transparency. As the nature and status of all basins are different, the challenges are not exactly the same. For example, hearing local voices and better information transparency have significantly improved in the Waikato River.

As the challenges for implementing the two principles are not purely legal, the responses should blend legal solutions with political and socio-economic solutions. Therefore, this thesis strongly supports shared sovereignty among states at the international level as well as shared sovereignty with indigenous and minority groups at the national level. Cooperation among national and international actors in the river basins is also crucial for implementing the two principles effectively. Finally, there is the opportunity to establish basin institutions or organisations to manage river basins integrated and sustainable. This is vital in the case of TE-RB because the basin still lacks an institution. Furthermore, the basin institution in the MDB requires more robust compliance and monitoring power because the provisions of the Water Act 2007 and the basin plan still have not been implemented effectively.

Finally, the thesis concludes with two common lessons in comparing these cases. The first lesson is that equitable utilisation cannot be implemented effectively if it is not accepted by the local community in a broad and deep meaning. It means that the equitable allocation should be extended from only the riparian states to equitable allocation among the people within each state. The second lesson is that the minimisation of environmental harm cannot be implemented without determining the minimum flow of rivers, particularly transboundary rivers. Determining an environmental impact assessment for water projects and taking advantage of available solutions of nature contributes significantly in implementing the two principles and sustainable management of our rivers.

text: A trans-national analysis of equitable utilisation and minimisation of environmental harm under environmental laws at international, federal and national levels Due to increasing demand for various human needs and climate change issues, rivers are now under enormous pressure. With increasing pressure on these valuable natural resources, responses among state and non-state actors are insufficient in the Anthropocene. To fill the gap, International Environmental Law (IEL) provides several principles for better management of these resources. Equitable utilisation and minimisation of environmental harm are among the most important principles of the IEL. From a theoretical perspective, these principles should lead to the sustainability of these resources and promote cooperation among relevant actors.

However, many river basins are still not allocated equitably and suffer from environmental damage. By using comparative, doctrinal, and empirical research methods, this thesis evaluates the two principles at the international level in Tigris and Euphrates River Basin, the federal level in Murray Darling Basin and at the local level in the Waikato River catchment. The research discovered major challenges for implementing the two principles. One major challenge is sovereignty, another is a lack or weakness of local voices and transparency. As the nature and status of all basins are different, the challenges are not exactly the same. For example, hearing local voices and better information transparency have significantly improved in the Waikato River.

As the challenges for implementing the two principles are not purely legal, the responses should blend legal solutions with political and socio-economic solutions. Therefore, this thesis strongly supports shared sovereignty among states at the international level as well as shared sovereignty with indigenous and minority groups at the national level. Cooperation among national and international actors in the river basins is also crucial for implementing the two principles effectively. Finally, there is the opportunity to establish basin institutions or organisations to manage river basins integrated and sustainable. This is vital in the case of TE-RB because the basin still lacks an institution. Furthermore, the basin institution in the MDB requires more robust compliance and monitoring power because the provisions of the Water Act 2007 and the basin plan still have not been implemented effectively.

Finally, the thesis concludes with two common lessons in comparing these cases. The first lesson is that equitable utilisation cannot be implemented effectively if it is not accepted by the local community in a broad and deep meaning. It means that the equitable allocation should be extended from only the riparian states to equitable allocation among the people within each state. The second lesson is that the minimisation of environmental harm cannot be implemented without determining the minimum flow of rivers, particularly transboundary rivers. Determining an environmental impact assessment for water projects and taking advantage of available solutions of nature contributes significantly in implementing the two principles and sustainable management of our rivers.

year: 2023