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10. A core outcome set for future endometriosis research: an international consensus development study

Author

Duffy, Jmn, Hirsch, M, Vercoe, M, Abbott, J, Barker, C, Collura, B, Drake, R, Evers, Jlh, Hickey, M, Horne, Aw, Hull, Ml, Kolekar, S, Lensen, S, Johnson, Np, Mahajan, V, Mol, Bw, Otter, A‐s, Puscasiu, L, Rodriguez, Mb, Rombauts, L, Vail, A, Wang, R, Farquhar, Cm, Daniels, Jane P, Lim, Arianne C, Edmonds, Katie, Maclean, Claire E, Appleton, Amy C, Skelton, Sarah, Byrne, Dominic L, White, Rebecca K, Sardo, Margarida, Fowles, Rebecca C, Ata, Baris, Richatd, Sarah A, Puig Ybanez, Casandra C, Peterson, Matthew C, Elms, Jasmin L, Parks, Ann, De Bie Rocks, Bianca L F, Roe, Jodie C, Doran, Ruby, Ceccaroni, Marcello, Ferreira, Ceu A, Dias, Sofia, Pinnington, Tracey, Laupa‐santiago, Paula, Turner, Marie C, Schreurs, Anneke M F, Baggot, Eleanor, Socolov, Razvan V, Yossry, Menem, Hodges, Tania M, Barbossa, Marina W P, Mures, Târgu, Lytwyn, Tracy L, Egan‐reid, Sophia E L, Devlin, Susanna C L, Crees, Kira S, Baldwin, Bethany C, Scott, James R, Gravolin, Amy K, Chapman, Errin F, Bartley, Stephanie N, Hamilton, Alicia J, Thorpe, Kirstie J, Carmody, Denise M, Eyeson, Joanna, Davis, Madeleine D, Henry, Jo, Armour, Mike, Cummings, Presley Y F V, Cook, Lisa A, and RS: GROW - R4 - Reproductive and Perinatal Medicine

Subjects
Research design, endometriosis, medicine.medical_specialty, Biomedical Research, Consensus, Delphi Technique, Endpoint Determination, Health Personnel, Population, Endometriosis, modified nominal group technique, core outcome set, Miscarriage, 03 medical and health sciences, 0302 clinical medicine, Consensus development study, medicine, Humans, Prospective Studies, Intensive care medicine, education, Pregnancy, education.field_of_study, 030219 obstetrics & reproductive medicine, Ectopic pregnancy, business.industry, Obstetrics and Gynecology, medicine.disease, Research Personnel, Systematic review, Research Design, Female, Live birth, business, modified delphi method
Abstract

Objective To develop a core outcome set for endometriosis. Design Consensus development study. Setting International. Population One hundred and sixteen healthcare professionals, 31 researchers and 206 patient representatives. Methods Modified Delphi method and modified nominal group technique. Results The final core outcome set includes three core outcomes for trials evaluating potential treatments for pain and other symptoms associated with endometriosis: overall pain; improvement in the most troublesome symptom; and quality of life. In addition, eight core outcomes for trials evaluating potential treatments for infertility associated with endometriosis were identified: viable intrauterine pregnancy confirmed by ultrasound; pregnancy loss, including ectopic pregnancy, miscarriage, stillbirth and termination of pregnancy; live birth; time to pregnancy leading to live birth; gestational age at delivery; birthweight; neonatal mortality; and major congenital abnormalities. Two core outcomes applicable to all trials were also identified: adverse events and patient satisfaction with treatment. Conclusions Using robust consensus science methods, healthcare professionals, researchers and women with endometriosis have developed a core outcome set to standardise outcome selection, collection and reporting across future randomised controlled trials and systematic reviews evaluating potential treatments for endometriosis. TWEETABLE ABSTRACT: @coreoutcomes for future #endometriosis research have been developed @jamesmnduffy.

Published
2020
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12. The rationality of groundwater governance in the Vietnamese Mekong Delta’s coastal zone

Author

Hamer, Thomas, Dieperink, Carel, Tri, Van Pham Dang, Otter, Henriëtte S., Hoekstra, Piet, Environmental Governance, Proceskunde, Coastal dynamics, Fluvial systems and Global change, Environmental Governance, Proceskunde, and Coastal dynamics, Fluvial systems and Global change

Subjects
Groundwater governance, Corporate governance, Vietnamese, groundwater depletion, 0208 environmental biotechnology, rational governance, Rationality, 02 engineering and technology, stakeholder participation, 010501 environmental sciences, Development, 01 natural sciences, language.human_language, 020801 environmental engineering, Geography, Coastal zone, language, Water resource management, Mekong delta, Groundwater, Vietnamese Mekong Delta, 0105 earth and related environmental sciences, Water Science and Technology
Abstract

This article assesses the rationality of the governance of the Vietnamese coastal zone’s water system. We first specify five assessment criteria, which we apply to a case study. Based on document analysis, stakeholder surveys and in-depth interviews, we found an average score on the criterion that relevant water system knowledge must be available. The scores on the criteria that water usage is systematically monitored, that the legal framework is complied with, that long-term human and wider ecological interests are addressed, and that governance is decentralized appeared to be low. The article concludes with some recommendations to change the governance system.

Published
2020

13. The rationality of groundwater governance in the Vietnamese Mekong Delta’s coastal zone

Author

Environmental Governance, Proceskunde, Coastal dynamics, Fluvial systems and Global change, Hamer, Thomas, Dieperink, Carel, Tri, Van Pham Dang, Otter, Henriëtte S., Hoekstra, Piet, Environmental Governance, Proceskunde, Coastal dynamics, Fluvial systems and Global change, Hamer, Thomas, Dieperink, Carel, Tri, Van Pham Dang, Otter, Henriëtte S., and Hoekstra, Piet

Published
2020

15. Developing a core outcome set for future infertility research: an international consensus development study†  ‡.

Author

Duffy, J M N, AlAhwany, H, Bhattacharya, S, Collura, B, Curtis, C, Evers, J L H, Farquharson, R G, Franik, S, Giudice, L C, Khalaf, Y, Knijnenburg, J M L, Leeners, B, Legro, R S, Lensen, S, Vazquez-Niebla, J C, Mavrelos, D, Mol, B W J, Niederberger, C, Ng, E H Y, and Otter, A S

Subjects
INFERTILITY, ABORTION, HUMAN reproduction, MULTIPLE pregnancy, INFERTILITY treatment, RESEARCH, RESEARCH methodology, MEDICAL cooperation, EVALUATION research, PREGNANCY outcomes, COMPARATIVE studies
Abstract

Study Question: Can a core outcome set to standardize outcome selection, collection and reporting across future infertility research be developed?Summary Answer: A minimum data set, known as a core outcome set, has been developed for randomized controlled trials (RCTs) and systematic reviews evaluating potential treatments for infertility.What Is Known Already: Complex issues, including a failure to consider the perspectives of people with fertility problems when selecting outcomes, variations in outcome definitions and the selective reporting of outcomes on the basis of statistical analysis, make the results of infertility research difficult to interpret.Study Design, Size, Duration: A three-round Delphi survey (372 participants from 41 countries) and consensus development workshop (30 participants from 27 countries).Participants/materials, Setting, Methods: Healthcare professionals, researchers and people with fertility problems were brought together in an open and transparent process using formal consensus science methods.Main Results and the Role Of Chance: The core outcome set consists of: viable intrauterine pregnancy confirmed by ultrasound (accounting for singleton, twin and higher multiple pregnancy); pregnancy loss (accounting for ectopic pregnancy, miscarriage, stillbirth and termination of pregnancy); live birth; gestational age at delivery; birthweight; neonatal mortality; and major congenital anomaly. Time to pregnancy leading to live birth should be reported when applicable.Limitations, Reasons For Caution: We used consensus development methods which have inherent limitations, including the representativeness of the participant sample, Delphi survey attrition and an arbitrary consensus threshold.Wider Implications Of the Findings: Embedding the core outcome set within RCTs and systematic reviews should ensure the comprehensive selection, collection and reporting of core outcomes. Research funding bodies, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement, and over 80 specialty journals, including the Cochrane Gynaecology and Fertility Group, Fertility and Sterility and Human Reproduction, have committed to implementing this core outcome set.Study Funding/competing Interest(s): This research was funded by the Catalyst Fund, Royal Society of New Zealand, Auckland Medical Research Fund and Maurice and Phyllis Paykel Trust. The funder had no role in the design and conduct of the study, the collection, management, analysis or interpretation of data, or manuscript preparation. B.W.J.M. is supported by a National Health and Medical Research Council Practitioner Fellowship (GNT1082548). S.B. was supported by University of Auckland Foundation Seelye Travelling Fellowship. S.B. reports being the Editor-in-Chief of Human Reproduction Open and an editor of the Cochrane Gynaecology and Fertility group. J.L.H.E. reports being the Editor Emeritus of Human Reproduction. 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.J.M. reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. 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. A.S. reports consultancy fees from Guerbet. E.H.Y.N. reports research sponsorship from Merck. 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 work presented. All authors have completed the disclosure form.Trial Registration Number: Core Outcome Measures in Effectiveness Trials Initiative: 1023. [ABSTRACT FROM AUTHOR]

Published
2020
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16. Governance conditions for adaptive freshwater management in the Vietnamese Mekong Delta

Author

Ha, T. P., Dieperink, Carel, Dang Tri, Van Pham, Otter, Henriëtte S., Hoekstra, Piet, Ha, T. P., Dieperink, Carel, Dang Tri, Van Pham, Otter, Henriëtte S., and Hoekstra, Piet

Abstract

The Vietnamese Mekong Delta (VMD) is a region of utmost importance to Vietnam's national food security. However, the availability of required freshwater resources (from both surface and groundwater sources) is currently under great threats due to dry season salinity intrusion, surface water pollution, and over-exploitation of groundwater. Global climate change, sea level rise, and upstream and in situ development activities may worsen the situation. Assuming that adaptive management could be a promising strategy to address the increasingly complex and unpredictable water-related problems in the VMD, we design and apply a framework to identify the extent to which the governance regime in this region exhibits conditions that are likely to promote adaptive freshwater management. Using both primary and secondary data, our analysis reveals that the prospects for adaptive water management in the study area are limited since several conditions were not present. We observe among others limitations in vertical and horizontal integration and public participation, restraints in knowledge and information sharing, inadequate policy development and implementation, and insufficient diversification of financial resources. Following our findings, we conclude the paper with recommendations both for national, regional and local policy interventions and for future research.

Published
2018

17. Governance conditions for adaptive freshwater management in the Vietnamese Mekong Delta

Author

Environmental Governance, Faculteit Geowetenschappen, Coastal dynamics, Fluvial systems and Global change, Ha, T. P., Dieperink, Carel, Dang Tri, Van Pham, Otter, Henriëtte S., Hoekstra, Piet, Environmental Governance, Faculteit Geowetenschappen, Coastal dynamics, Fluvial systems and Global change, Ha, T. P., Dieperink, Carel, Dang Tri, Van Pham, Otter, Henriëtte S., and Hoekstra, Piet

Published
2018

23. Testing and validating the CERES-wheat (Crop Estimation through Resource and Environment Synthesis-wheat) model in diverse environments

Author

Otter-Nacke, S, Godwin, D. C, and Ritchie, J. T

Subjects
Earth Resources And Remote Sensing
Abstract

CERES-Wheat is a computer simulation model of the growth, development, and yield of spring and winter wheat. It was designed to be used in any location throughout the world where wheat can be grown. The model is written in Fortran 77, operates on a daily time stop, and runs on a range of computer systems from microcomputers to mainframes. Two versions of the model were developed: one, CERES-Wheat, assumes nitrogen to be nonlimiting; in the other, CERES-Wheat-N, the effects of nitrogen deficiency are simulated. The report provides the comparisons of simulations and measurements of about 350 wheat data sets collected from throughout the world.

Published
1986

25. Greening Flood Protection—An Interactive Knowledge Arrangement Perspective.

Author

Janssen, Stephanie K.H., van Tatenhove, Jan P.M., Otter, Henriëtte S., and Mol, Arthur P.J.

Subjects
FLOOD damage prevention, ECOSYSTEM dynamics, KNOWLEDGE management, ENVIRONMENTAL policy, TECHNOLOGICAL innovations
Abstract

In flood protection, the dominant paradigm of ‘building hard structures’ is being challenged by approaches that integrate ecosystem dynamics and are ‘nature-based’. Knowledge development and policy ambitions on greening flood protection (GFP) are rapidly growing, but a deficit remains in actual full-scale implementation. Knowledge is a key barrier for implementation. To analyse conditions for the implementation of GFP, a knowledge-arrangement perspective is developed. The knowledge-arrangement perspective is applied on a case study of successful implementation of GFP in the Netherlands, the pilot Sand Engine Delfland, a large-scale (21.5 Mm3) sand nourishment project. This project confirms that an integrated knowledge arrangement enables GFP as it allows for multifunctionality. Effectiveness of the integrated arrangement in this project is explained by its ‘flexible’ nature providing ample design space. This was possible because core values in flood protection and nature were not part of the integrated arrangement. More generally the case study demonstrates the difficulties of implementing GFP in existing mainstream flood protection routines. These are not (yet) geared to incorporate uncertainty, dynamics and multifunctionality, characteristics associated with GFP. The Sand Engine project can be regarded as a ‘field laboratory’ of physical and institutional learning and an innovation for mainstream flood protection. [ABSTRACT FROM AUTHOR]

Published
2015
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28. A comparison of the performance of N simulation models in the prediction of Nminon farmers' fields in the spring

Author

Otter-Nacke, S. and Kuhlmann, H.

Abstract

The performance of three different models, which simulate changes in the inorganic N content of the soil, was evaluated in respect of their ability to predict Nmincontent in the spring under cereal crops. The models of British, Dutch and German origin, were tested using data from farmers' fields supplied by 70 farmers over two growing seasons in FRG. The models were run between harvest of the previous crop and spring of the following year, and predictions of Nminin the spring compared to soil measurements. The performance of the models was assessed by counting the number of cases in which predictions agreed within 10 or 20 kg (N) ha-1of the measurements. Predictions were less than ± 10 kg (N) ha-1of measured values in only 30–44% and 28–55% of cases in 1988 and 1989, respectively. Predictions were less than ± 20 kg (N) ha-1of measured values in 62–70% and 68–82% of cases in 1988 and 1989, respectively. Predictions in 1989 were better because the initial Nmincontent in the autumn was included in the model input. None of the models tested had been designed to use input data of the type available to farmers. It is concluded that, at present, the results are too variable for any of the models to be used with confidence as tools to aid in N fertilizer recommendations.

Published
1991
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29. Uncertainty in integrated coastal zone management

Author

Capobianco, Michele and Otter, Henriette S.

Subjects
CONSERVATION of natural resources, ECOLOGY, GEOMORPHOLOGY, MODELING (Sculpture), SIMULATION methods & models, UNCERTAINTY, COASTAL zone management
Abstract

Uncertainty plays a major role in Integrated Coastal Zone Management(ICZM). A large part of this uncertainty is connected to our lack ofknowledge of the integrated functioning of the coastal system and tothe increasing need to act in a pro-active way. Increasingly, coastal managers are forced to take decisions based on information which issurrounded by uncertainties. Different types of uncertainty can be identified and the role of uncertainty in decision making, scientific uncertainty and model uncertainty in ICZM is discussed. The issue of spatial variability, which is believed to be extremely important in ICZM and represents a primary source of complexity and uncertainty, isalso briefly introduced. Some principles for complex model building are described as an approach to handle, in a balanced way, the available data, information, knowledge and experience. The practical methodof sensitivity analysis is then introduced as a method for a posterior evaluation of uncertainty in simulation models. We conclude by emphasizing the need for the definition of an analysis plan in order to handle model uncertainty in a balanced way during the decision makingprocess. [ABSTRACT FROM AUTHOR]

Published
2000
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30. Developing a core outcome set for future infertility research: an international consensus development study.

Author

Duffy, J M N, AlAhwany, H, Bhattacharya, S, Collura, B, Curtis, C, Evers, J L H, Farquharson, R G, Franik, S, Giudice, L C, Khalaf, Y, Knijnenburg, J M L, Leeners, B, Legro, R S, Lensen, S, Vazquez-Niebla, J C, Mavrelos, D, Mol, B W J, Niederberger, C, Ng, E H Y, and Otter, A S

Subjects
*INFERTILITY treatment, *PROFESSIONAL practice, *RESEARCH, *RESEARCH methodology, *EVIDENCE-based medicine, *ACQUISITION of data, *MEDICAL cooperation, *EVALUATION research, *INFERTILITY, *MEDICAL protocols, *COMPARATIVE studies, *MEDICAL research, *REPRODUCTIVE health, *DELPHI method, *STANDARDS
Abstract

Study Question: Can a core outcome set to standardize outcome selection, collection, and reporting across future infertility research be developed?Summary Answer: A minimum data set, known as a core outcome set, has been developed for randomized controlled trials (RCT) and systematic reviews evaluating potential treatments for infertility.What Is Known Already: Complex issues, including a failure to consider the perspectives of people with fertility problems when selecting outcomes, variations in outcome definitions, and the selective reporting of outcomes on the basis of statistical analysis, make the results of infertility research difficult to interpret.Study Design, Size, Duration: A three-round Delphi survey (372 participants from 41 countries) and consensus development workshop (30 participants from 27 countries).Participants/materials, Setting, Methods: Healthcare professionals, researchers, and people with fertility problems were brought together in an open and transparent process using formal consensus science methods.Main Results and the Role Of Chance: The core outcome set consists of: viable intrauterine pregnancy confirmed by ultrasound (accounting for singleton, twin, and higher multiple pregnancy); pregnancy loss (accounting for ectopic pregnancy, miscarriage, stillbirth, and termination of pregnancy); live birth; gestational age at delivery; birthweight; neonatal mortality; and major congenital anomaly. Time to pregnancy leading to live birth should be reported when applicable.Limitations, Reasons For Caution: We used consensus development methods which have inherent limitations, including the representativeness of the participant sample, Delphi survey attrition, and an arbitrary consensus threshold.Wider Implications Of the Findings: Embedding the core outcome set within RCTs and systematic reviews should ensure the comprehensive selection, collection, and reporting of core outcomes. Research funding bodies, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement, and over 80 specialty journals, including the Cochrane Gynaecology and Fertility Group, Ferility and Sterility, and Human Reproduction, have committed to implementing this core outcome set.Study Funding/competing Interest(s): This research was funded by the Catalyst Fund, Royal Society of New Zealand, Auckland Medical Research Fund, and Maurice and Phyllis Paykel Trust. Siladitya Bhattacharya reports being the Editor-in-Chief of Human Reproduction Open and an editor of the Cochrane Gynaecology and Fertility group. Hans Evers reports being the Editor Emeritus of Human Reproduction. José Knijnenburg reports research sponsorship from Ferring and Theramex. Richard Legro reports consultancy fees from Abbvie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. Ben Mol reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. Craig Niederberger 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. Annika Strandell reports consultancy fees from Guerbet. Ernest Ng reports research sponsorship from Merck. Lan Vuong reports consultancy and conference fees from Ferring, Merck and Merck Sharp and Dohme. The remaining authors declare no competing interests in relation to the work presented. All authors have completed the disclosure form.Trial Registration Number: Core Outcome Measures in Effectiveness Trials Initiative: 1023. [ABSTRACT FROM AUTHOR]

Published
2021
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31. Interactive knowledge development in coastal projects

Author

Seijger, Chris, Dewulf, Geert, van Tatenhove, Jan P.M., Otter, Henriëtte S., Faculty of Engineering Technology, and University of Twente

Abstract

A sustainable future of the coastal environment is severely at risk since the coasts are deteriorating and human dependence on coastal space and resources continues to increase. Seeking solutions for coastal development is challenging. Problems of flood control, nature restoration and spatial development are complex, cover multiple interests of for instance economic growth and nature preservation and include large knowledge uncertainties like climate change and soil subsidence. Given this complex reality, the knowledge of researchers is not sufficient to respond to complex coastal problems. Instead, knowledge should be developed in interaction between researchers, policy makers and other societal actors. The objective of this PhD thesis is to explore how processes of interactive knowledge development function in coastal projects. A conceptual framework of project and knowledge arrangements is applied to analyse interactive knowledge development in coastal projects. An arrangement consists of four interrelated dimensions: actors, resources, rules and discourses. The project arrangement focuses on the overall project goals and the activities undertaken to achieve them. The knowledge arrangement conceptualises the process of interactive knowledge development for a particular solution in the project. The conceptual framework is applied in three case studies: the Texel dike reinforcement project in the Wadden Sea, the South Bay Salt Pond Restoration project in San Francisco Bay and the Marconi spatial development project in Delfzijl on the banks of the Ems estuary. Data were collected through interviews, observations of project meetings, project documents and field visits. The thesis presents eleven generic mechanisms that explain how a process of interactive knowledge development functions in the studied coastal projects. The mechanisms highlight that interactive knowledge development enhances the feasibility and public support of developed solutions. In addition, the mechanisms show that interactive knowledge development requires specific measures such as a facilitator and easily understood knowledge, to align the contributions of participating actors. Lastly, the mechanisms show that a process of interactive knowledge development consumes substantial more time than ‘basic’ research to address the concerns of participating actors. The thesis ends with recommendations for practitioners who aim to develop knowledge interactively.

Published
2014

32. Conquering complexity - Dealing with uncertainty and ambiguity in water management

Author

Hommes, Saskia, Hulscher, Suzanne J.M.H., Bressers, Hans T.A., Otter, Henriëtte S., and Marine and Fluvial Systems

Subjects
METIS-250177, IR-60258
Abstract

Water management problems are embedded in a natural and social system that is characterized by complexity. Knowledge uncertainty and the existence of divergent actors’ perceptions contribute to this complexity. Consequently, dealing with water management issues is not just a knowledge uncertainty problem; it is a problem of ambiguity too. This PhD-research focuses on decision-making processes for complex water management issues. We investigated how a decision-making process, for a complex water management issue, influences the creation of a knowledge base, the development of actors’ perceptions and the formulation of a problem-solution combination. Three case studies of complex water management issues are presented, two explorative case studies from practice and a comparative experiment. The first case study focuses on the decision-making process for the impact assessment of the extension of Mainport Rotterdam. This process can be characterized as an analytical decision-making process, as it is based on rationality and objectivity. The second case study focuses on the sustainable development of ecology, economy and society in the Delta region, in the southwest of the Netherlands. This project is a typical example of a participatory decision-making process, which actively involves actors and is open to divergent perceptions of the problem. In our third case study, two decision-making processes – analytical and participatory – are compared using an experimental setup. The comparison between the two decision-making processes was carried out within the framework of a multidisciplinary design project for Civil Engineering Bachelor-students of the University of Twente.

Published
2008

33. Top 10 priorities for future infertility research: an international consensus development study.

Author

Duffy JMN, Adamson GD, Benson E, Bhattacharya S, Bhattacharya S, Bofill M, Brian K, Collura B, Curtis C, Evers JLH, Farquharson RG, Fincham A, Franik S, Giudice LC, Glanville E, Hickey M, Horne AW, Hull ML, Johnson NP, Jordan V, Khalaf Y, Knijnenburg JML, Legro RS, Lensen S, MacKenzie J, Mavrelos D, Mol BW, Morbeck DE, Nagels H, Ng EHY, Niederberger C, Otter AS, Puscasiu L, Rautakallio-Hokkanen S, Sadler L, Sarris I, Showell M, Stewart J, Strandell A, Strawbridge C, Vail A, van Wely M, Vercoe M, Vuong NL, Wang AY, Wang R, Wilkinson J, Wong K, Wong TY, and Farquhar CM

Subjects
Consensus, Delphi Technique, Female, Fertility Clinics organization & administration, Fertility Clinics standards, Fertility Clinics trends, Humans, International Cooperation, Male, Practice Guidelines as Topic standards, Pregnancy, Reproductive Medicine organization & administration, Reproductive Medicine standards, Research organization & administration, Research standards, Infertility etiology, Infertility therapy, Reproductive Medicine trends, Research trends
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 were 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 judgement, 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. Geoffrey Adamson 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. Hans Evers reports being the Editor Emeritus of Human Reproduction. Andrew Horne 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. Louise Hull reports grants from Merck, grants from Myovant, grants from Bayer, outside the submitted work and ownership in Embrace Fertility, a private fertility company. Neil Johnson reports research sponsorship from Abb-Vie and Myovant Sciences and consultancy fees from Guerbet, Myovant Sciences, Roche Diagnostics, and Vifor Pharma. José Knijnenburg reports research sponsorship from Ferring and Theramex. Richard Legro reports consultancy fees from Abbvie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. Ben Mol reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. Ernest Ng reports research sponsorship from Merck. Craig Niederberger 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. Jane Stewart 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. Annika Strandell reports consultancy fees from Guerbet. Jack Wilkinson reports being a statistical editor for the Cochrane Gynaecology and Fertility Group. Andy Vail reports that he is a Statistical Editor of the Cochrane Gynaecology & Fertility Review Group and of the journal Reproduction. His employing institution has received payment from HFEA for his advice on review of research evidence to inform their 'traffic light' system for infertility treatment 'add-ons'. Lan Vuong 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: Not applicable., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Published
2021
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34. Top 10 priorities for future infertility research: an international consensus development study†  ‡.

Author

Duffy JMN, Adamson GD, Benson E, Bhattacharya S, Bhattacharya S, Bofill M, Brian K, Collura B, Curtis C, Evers JLH, Farquharson RG, Fincham A, Franik S, Giudice LC, Glanville E, Hickey M, Horne AW, Hull ML, Johnson NP, Jordan V, Khalaf Y, Knijnenburg JML, Legro RS, Lensen S, MacKenzie J, Mavrelos D, Mol BW, Morbeck DE, Nagels H, Ng EHY, Niederberger C, Otter AS, Puscasiu L, Rautakallio-Hokkanen S, Sadler L, Sarris I, Showell M, Stewart J, Strandell A, Strawbridge C, Vail A, van Wely M, Vercoe M, Vuong NL, Wang AY, Wang R, Wilkinson J, Wong K, Wong TY, Farquhar CM, AlAhwany H, Balaban O, Barton F, Beebeejaun Y, Boivin J, Bosteels JJA, Calhaz-Jorge C, D’Angelo A, F. Dann L, J. De Jonge C, du Mez E, A. Ferriani R, Gerval MO, J. Gingel L, Greenblatt EM, Hartshorne G, Helliwell C, Hughes LJ, Jo J, Jovanović J, Kiesel L, Kietpeerakool C, Kostova E, Kucuk T, Kumar R, Lawrence RL, Lee N, Lindemann KE, Loto OM, Lutjen PJ, MacKinven M, Mascarenhas M, McLaughlin H, Mourad SM, Nguyen LK, Norman RJ, Olic M, Overfield KL, Parker-Harris M, Repping S, Rizzo R, Salacone P, Saunders CH, Sengupta R, Sfontouris IA, Silverman NR, Torrance HL, Uphoff EP, Wakeman SA, Wischmann T, Woodward BJ, and Youssef MA

Subjects
Consensus, Female, Humans, Male, New Zealand, Ovulation Induction, Infertility therapy, State Medicine
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., (© The Author(s) 2020. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.)

Published
2020
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