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.

抽象的项目概要/摘要拟议的生物伦理问题研究行政补充的重点是支持旨在为未来政策方向提供信息的证据基础的开发涉及知情同意对出生时躯体性别发育不典型的未成年人进行选择性泌尿生殖手术的做法，即差异 / 性发育障碍 (DSD) 是染色体、性腺或性发育障碍的先天性疾病。解剖学上的性别发育是不典型的，DSD 包括一系列的医学病症，这些病症共同具有。发病率约占人口的 1%，与不孕症、性腺癌风险增加有关，性别焦虑、社会心理困扰以及患者和社会心理适应的普遍挑战对于每个新发现 DSD 的人来说，有多种临床管理选择。考虑一下，其中大多数在情感和道德上都具有挑战性，会引发辩论和关注。跨专业、倡导和患者社区涉及在实施之前充分知情同意未成年人的选择性泌尿生殖手术。知情同意不仅意味着一种形式，而且意味着一个过程，以及作为该过程记录的签名文件当前知情同意实践的一个重大问题涉及决策者的访问。并理解所有信息材料以做出明智的决定，并结合权衡根据个人价值观和偏好当前的手术知情同意书的潜在危害和益处。然而，DSD 泌尿生殖手术使用的文件通常与任何其他泌尿生殖手术的文件相同。手术过程。鉴于围绕同意程序的具体担忧和争议，有关代理的现状对选择性和不可逆转的外科手术的知情“许可”似乎不够充分，原因尚不清楚。尚未使用更详细且DSD特定的语言和形式，以及实施过程中存在哪些障碍该项目的目标是设计新的手术同意书（或语言）。可以纳入既定表格或作为既定表格的必要附录）。通过创建有关当前标准外科手术知情特征的知识库来完成同意文件及应包含的内容（通过专家意见调查），综合比较确定的需求与当前状态，以拟议语言的形式总结调查结果纳入标准化知情同意文件，并系统识别和编目改变当前知情同意文件的障碍延伸到法律和政策层面领域。

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].