Disorders/Differences of Sex Development (DSD) - Translational Research Network

性发育障碍/差异 (DSD) - 转化研究网络

基本信息

批准号：
10590830
负责人：
DAVID Eric. SANDBERG
金额：
$ 13.26万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-07-15 至 2024-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10590830
关键词：
Addendum Address Administrative Supplement Advocacy Anatomy Authorization documentation Award Bioethical Issues Bioethics Bioethics Consultants Caregivers Caring Cataloging Child Childhood Clinical Clinical Management Communities Consent Consent Forms Data Decision Making Development Disease Distress Documentation Elective Surgical Procedures Elements Emotional Endocrine Ethics Expert Opinion Family Foundations Future Genitourinary system Goals Incidence Infertility Informed Consent Institutional Policy Intervention Language Legal Light Medical Medical Records Minor Online Systems Operative Surgical Procedures Parents Patient Care Patients Persons Policies Population Procedures Process Professional Organizations Provider Proxy Research Research Personnel Risk Sexual Development Site Societies Standardization Surveys Time Translating Translational Research Urogenital Surgical Procedures Urology cancer risk community involvement design evidence base gender dysphoria gonadal cancer implementation barriers improved information gathering knowledge base medical specialties member preference psychosocial sex development disorder shared decision making

项目摘要

ABSTRACT Project Summary / Abstract The focus of the proposed administrative supplement for research on bioethical issues supporting the development of an evidence base intended to inform future policy directions involves informed consent practices for elective urogenital surgery in minors born with atypical somatic sex development, i.e., differences / disorders of sex development (DSD). DSD are congenital conditions in which chromosomal, gonadal, or anatomic sex development is atypical. DSD comprise a spectrum of medical conditions that, collectively, have an incidence of ~1% of the population and are associated with increased infertility, risks of gonadal cancer, gender dysphoria, psychosocial distress, and pervasive challenges to psychosocial adaptation for patients and their families. For every person with a newly identified DSD, there are multiple clinical management options to consider, most of which are emotionally and ethically challenging. One topic triggering debate and concern across professional, advocacy, and patient communities involves the adequacy of informed consent prior to elective urogenital surgery in minors. Informed consent implies not just a form, but a process, and signed documentation serving as a record of that process. A significant concern regarding current informed consent practices involves decision makers’ access to and understanding of all information material to making an informed decision, combined with weighing potential harms and benefits in light of personal values and preferences. Current surgical informed consent documents used for urogenital surgery in DSD are, however, generally the same as those for any other surgical procedure. Given specific concerns and controversies surrounding consent procedures, the status quo regarding proxy informed “permission” for elective and irreversible surgical procedures appears inadequate. It is unclear why more detailed and DSD-specific language and forms are not in use and what barriers exist in implementation of forms with augmented details. The goal of this project is to design new surgical consent forms (or language that can be incorporated into, or function as a required addendum to, established forms). This will be accomplished by creating a knowledge base regarding current the features of standard surgical informed consent documents and what should be included (via expert opinion survey), comprehensively comparing identified needs vs the current status, summarizing findings in the form of proposed language intended for inclusion in standardized informed consent documents, and systematic identification and cataloguing of barriers to altering current informed consent documents extending into legal and policy-level realms.

抽象的项目摘要 /摘要拟议的行政补充的重点是研究生物伦理问题的研究旨在告知未来政策指示的证据基础的发展涉及知情同意未成年人的泌尿生殖器手术的实践 /性发展疾病（DSD）。 DSD是先天性条件，染色体，性腺或解剖性发展是非典型的。 DSD包括一系列医疗状况约有1％的人口的事件与不育的增加有关，性腺癌的风险，性别烦躁不安，社会心理困扰以及对患者的社会心理适应的普遍挑战他们的家人。对于每个有新近识别DSD的人，都有多种临床管理选项考虑一下，其中大多数在情感和道德上都受到挑战。一个主题引发辩论和关注跨专业，倡导和患者社区涉及知情同意的适当性未成年人的泌尿生殖器手术。知情同意书不仅意味着一种表格，而且意味着一个流程，并签署了作为记录的文档过程。对当前知情同意惯例的一个重大关注涉及决策者的访问对所有信息材料的理解，以做出明智的决定，并结合加权根据个人价值观和偏好，潜在的危害和益处。当前的手术知情同意但是，用于DSD中泌尿生殖器手术的文档通常与其他任何文件相同外科手术。考虑到围绕同意程序的具体问题和争议，有关代理的现状明智的“许可”获得了选修和不可逆转的手术程序，这似乎不足。目前尚不清楚为什么不使用更详细和DSD特定的语言和形式，并且在实施中存在哪些障碍具有增强细节的表格。该项目的目的是设计新的手术同意书（或语言）可以将其合并到已建立的表格中所需的附录中或作为所需的附录中。这将是通过创建有关当前标准手术知情的特征的知识库来完成同意文件以及应包括的内容（通过专家意见调查），全面比较确定的需求与当前状态，以旨在的拟议语言的形式总结发现纳入标准化的知情同意文件，以及系统的识别和分类更改当前知情同意文件的障碍，该文件扩展到法律和政策级领域。

项目成果

期刊论文数量（27）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Towards improved genetic diagnosis of human differences of sex development.

DOI：
10.1038/s41576-021-00365-5
发表时间：
2021-09
期刊：
Nature reviews. Genetics
影响因子：
0
作者：
通讯作者：

Preface: Challenges in caring for patients with disorders of sex development.

前言：护理性发育障碍患者面临的挑战。

DOI：
10.1016/j.sempedsurg.2019.150837
发表时间：
2019
期刊：
Seminars in pediatric surgery
影响因子：
1.7
作者：
vanLeeuwen,Kathleen;Grimsby,Gwen;Weidler,EricaM
通讯作者：
Weidler,EricaM

Information sharing in differences of sex development: The creation of a caregiver-support tool.

性别发育差异的信息共享：创建护理人员支持工具。

DOI：
10.1037/fsh0000724
发表时间：
2023
期刊：
Families, systems & health : the journal of collaborative family healthcare
影响因子：
0
作者：
Moyer,DanielleN;Suorsa-Johnson,KristinaI;Weidler,EricaM;Ernst,MichelleM;DSD-TRNPsychosocialWorkgroup
通讯作者：
DSD-TRNPsychosocialWorkgroup

Gender identity: A psychosocial primer for providing care to patients with a disorder/difference of sex development and their families [individualized care for patients with intersex (Disorders/differences of sex development): Part 2].