Effect of Validated Skills Simulation with the Miya Model on Operating Room Performance of Vaginal Hysterectomy

Miya 模型经过验证的技能模拟对阴式子宫切除术手术室表现的影响

• 批准号: 10267677
• 负责人: Bruce D Anderson
• 金额: $ 99.8万
• 依托单位: MIYAZAKI ENTERPRISES, LLC
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-05-15 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10267677
• 关键词: Abdomen; American College of Obstetricians and Gynecologists; Anatomy; Assessment tool; Atopobium vaginae; Benchmarking; Bladder; Childbirth; Competence; Complex; Credentialing; Device or Instrument Development; Discipline of Nursing; Education; Educational Curriculum; Educational process of instructing; Environment; Equipment Design; Evaluation; Evaluation Studies; Faculty; Fecal Incontinence; Feedback; Female; Goals; Gynecologic; Gynecology; Health; Health Professional; Healthcare; Hospital Societies; Hospitals; Hysterectomy; Incontinence; Institution; International; Laparoscopic Surgical Procedures; Life; Measurable; Medical Care Costs; Medical Device; Medical Residency; Medical Societies; Modeling; Modification; Morbidity - disease rate; Operating Rooms; Operative Surgical Procedures; Organ Size; Palpable; Pap smear; Participant; Patients; Pelvic Examination; Pelvis; Performance; Phase; Procedures; Production; Program Development; Protocols documentation; Ptosis; Puncture procedure; Recovery; Research; Residencies; Risk; Skin; Small Business Innovation Research Grant; Speculums; Structure; Surgeon; System; Techniques; Testing; Trainers Training; Training; Training Programs; United States National Institutes of Health; Urinary Incontinence; Vagina; Vaginal Hysterectomy; Vascular System; Water; Woman; Women' s Health; base; commercial application; cost; cost efficient; curriculum development; design; equipment acquisition; experience; health training; improved; meetings; model design; pelvic organ prolapse; pressure; product development; programs; research and development; simulation; skills; tool; validation studies; virtual surgery; visual tracking

Miya Model™ Simulator: Phase II B Abstract OB/GYN Residents must develop numerous skills including pelvic exams, childbirth, open surgery, laparoscopic surgery, and vaginal surgery. Studies demonstrate that OB/GYN Residents lack training in vaginal surgical techniques, including Vaginal Hysterectomy (VH), the desired hysterectomy technique recommended by The American College of Obstetricians and Gynecologists (ACOG) because it is associated with less morbidity, quicker recovery and lower costs than abdominal hysterectomy. Furthermore, Residents do not receive adequate training in vaginal surgery techniques used to treat urinary incontinence, fecal incontinence or pelvic organ prolapse. The Miya Model™ is a complete female pelvic anatomy model designed to simulate real surgical experiences including lifelike skin and life-sized organs, realistic cutting and puncturing tensions, palpable surgical landmarks, a pressurized vascular system that bleeds when inadequate technique is used, and an inflatable bladder that can leak water if damaged. The model is modular in that all of the parts are designed as cartridges that are easily replaceable when damaged in a simulated surgery. The anatomic correctness of the model can be used to train a broad range of health professionals on general procedures like bimanual exam, speculum exam and pap smear, as well as advanced gynecologic vaginal surgeries. There is no commercially available simulator that can train vaginal surgery skills and basic gynecological procedures to a breadth of health professionals other than the Miya Model™. Phase I and II SBIR programs developed curriculua for performing VH, sling techniques for incontinence, and completed a Construct Validity study demonstrating that performance differences of novices and experts performing a VH on the Miya ModelTM were measurable. Construct Validity is a crucial step in a simulator being accepted as an assessment tool. Modifications suggested by surgeon feedback during the validation study were incorporated into a production design making the Miya Model™ and replacement cartridges more affordable while modifying the design based on surgeon feedback. Phase IIB will encompass four Specific Aims with the goal of determining if training on the Miya Model™ and its associated curricula will improve VH performance in the Operating Room (OR). This study will require assessing the baseline VH skills of Residents at six institutions, dividing the Residents into two groups for either standard or simulation training, and subsequently comparing the OR performance of both groups. When complete, the Miya Model™, curriculum, and assessment tools will be a complete training system used in OB/GYN residency programs to train vaginal surgery techniques and objectively assess surgical competency without any risk or harm to patients. It will be used in numerous and diverse residency, nursing and allied health educational programs for basic gynecology training. The Miya Model™ system will also be used by hospitals for credentialing and medical device companies for product development and training.

Miya Model™ 模拟器：II B 阶段摘要 妇产科住院医师必须培养多种技能，包括骨盆检查、分娩、开放手术、 腹腔镜手术、阴道手术。研究表明，妇产科住院医师缺乏以下方面的培训： 阴道手术技术，包括阴道子宫切除术 (VH)，即理想的子宫切除术技术 由美国妇产科医师学会 (ACOG) 推荐，因为它与 与经腹子宫切除术相比，发病率更低、恢复更快、成本更低。此外，居民 没有接受过用于治疗尿失禁、大便失禁的阴道手术技术的足够培训 失禁或盆腔器官脱垂。 Miya Model™ 是一个完整的女性骨盆解剖模型 旨在模拟真实的手术体验，包括逼真的皮肤和真人大小的器官、逼真的切割和 穿刺张力、可触及的手术标志、加压血管系统，当压力不足时会出血 使用了技术和充气气囊，如果损坏可能会漏水。该模型是模块化的，因为所有 这些部件被设计成盒式，在模拟手术中损坏时可以轻松更换。这 该模型的解剖学正确性可用于培训广泛的卫生专业人员 双手检查、窥器检查和子宫颈抹片检查等程序，以及高级妇科阴道检查 手术。目前还没有可以训练阴道手术技能和基本技能的市售模拟器 除 Miya Model™ 之外，还向众多健康专业人士提供妇科手术。第一期和第二期 SBIR 项目开发了用于实施 VH、失禁吊带技术的课程，并完成了 构建有效性研究证明执行 VH 的新手和专家的表现差异 Miya ModelTM 上的测量结果是可测量的。构造有效性是模拟器被接受为模拟器的关键一步 评估工具。纳入了验证研究期间外科医生反馈建议的修改 融入生产设计，使 Miya Model™ 和替换墨盒更加经济实惠，同时 根据外科医生的反馈修改设计。 IIB 阶段将包含四个具体目标，其目标是 确定 Miya Model™ 及其相关课程的培训是否会提高 VH 绩效 手术室（OR）。这项研究需要评估六个机构的住院医师的基线 VH 技能， 将住院医师分为两组进行标准训练或模拟训练，然后进行比较 两组的 OR 表现。完成后，Miya Model™、课程和评估工具将 是用于妇产科住院医师计划的完整培训系统，用于培训阴道手术技术和 客观评估手术能力，不对患者造成任何风险或伤害。它将被用于许多和 用于基本妇科培训的多样化住院医师、护理和联合健康教育计划。宫 Model™ 系统还将被医院用于认证，医疗器械公司用于产品认证 发展和培训。