A Prognostic System for Selecting Appropriate Level of Amputation

选择适当截肢程度的预后系统

• 批准号: 7871547
• 负责人: JOSEPH M CZERNIECKI
• 金额: --
• 依托单位: VA PUGET SOUND HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-07-01 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7871547
• 关键词: Accounting; Amendment; Amputation; Amputees; Anatomy; Caring; Clinical; Communication; Communities; Consent; Decision Making; Development; Distal; Ensure; Failure; Family; Funding; Future; Goals; Grant; Healed; Healthcare; Healthcare Systems; Hospitalization; Hospitals; Individual; Institution; Judgment; Lead; Life; Lower Extremity; Major Depressive Disorder; Measures; Medical; Medical Care Team; Medical center; Minor; Mission; Modeling; Morbidity - disease rate; Multi-Institutional Clinical Trial; Operative Surgical Procedures; Outcome; Patient Care; Patient Education; Patients; Performance; Peripheral Vascular Diseases; Policies; Population; Practice Guidelines; Probability; Prospective Studies; Provider; Quality of Care; Quality of life; Recruitment Activity; Recurrence; Rehabilitation Outcome; Rehabilitation therapy; Reporting; Research; Resources; Risk; Risk Factors; Services; Site; Surgeon; System; Time; Treatment outcome; Uncertainty; United States Department of Veterans Affairs; Validation; Vascular Diseases; Veterans; Work; abstracting; base; care systems; clinical care; clinical decision-making; diabetic; diabetic patient; disability; functional outcomes; healing; loss of function; mortality; multi-site trial; outcome forecast; prognostic; programs; prospective; psychologic; psychosocial; satisfaction; social; sound; success; tool

DESCRIPTION (provided by applicant): Project Summary/Abstract Our current prospective multi-site study has led to the development of a robust prognostic model among transfemoral (TF), transtibial (TT), and transmetatarsal (TM) amputees that we call AMPREDICT. AMPREDICT was developed to be used pre-operatively for treatment decision making by correlating outcome success with baseline demographic, physical and psychosocial measures. The ultimate goal of the proposed research is to validate AMPREDICT so that it can be recommended for widespread clinical use for the following purposes: (1) providing surgeons, rehabilitation teams, and patients with information about patient prognosis; (2) assisting surgeons, rehabilitation teams, and patients in planning the most appropriate level of amputation; (3) providing an objective tool for validly comparing treatment and rehabilitation outcomes; (4) assisting in the communication and exchange of information among clinicians and patients; and (5) assisting in VA-wide policy decisions to ensure sound judgment regarding the best level of care for each individual patient. To accomplish this, we plan to assess the performance of the prognostic model AMPREDICT by assessing its accuracy in different populations than the one it has been developed in. This research is critical before AMPREDICT is recommended for widespread clinical use. The primary aim for this study is to assess our current prognostic model's (AMPREDICT) performance for predicting both physical and psychosocial outcomes among TT and TM amputees in the same institution during a different time period (temporal transportability) and in different institutions (geographic transportability) so that it can be recommended for widespread clinical use. PUBLIC HEALTH RELEVANCE: Project Narrative About 10% of major amputations performed in the US are performed in Department of Veterans Affairs Medical Centers. Over 2600 major amputations were performed in DVA hospitals in fiscal year (FY) 2003. One of the primary determinants of functional outcome is the choice of amputation level. Amputation at the transfemoral level compared with the transtibial level significantly reduces the probability of attaining independent mobility and community ambulation. Choosing the optimum amputation level is complicated. The more distal the amputation the greater the potential for an enhanced functional outcome but the healing rate is reduced. A failure of healing may lead to prolonged or recurrent hospitalization with a need for additional surgery with its incumbent risks of additional morbidity and mortality. A recent VA Office of Patient Care Services Report entitled, "Lower Extremity Amputations in VHA; FY 1997-2003", demonstrates this inconsistency. It Compared 20 Veteran Integrated Service Networks (VISN) with respect to the TF/TT amputee ratio. Seven VISN's performed more TF amputations than TT amputations. The report illustrates there are VISN's that perform nearly twice as many transfemoral amputations as they perform transtibial amputations, and VISN's that perform 1/2 the number of transfemoral amputations as they perform transtibial amputations. It is clear that there is widespread variability in surgical practice. Over the past four years, our group has conducted the first prospective study of factors associated with treatment "success," and has developed a prognostic model we call AMPREDICT. This robust prognostic model examines baseline demographic, medical, physical and psychosocial risk factors predicting medical and psychosocial outcomes. Implementation of AMPREDICT will provide a valuable clinical decision-making tool to providers to help them determine the appropriate level of amputation for their patients. However, before a prognostic model can be recommended for widespread clinical use, its performance needs to be established. This is accomplished through temporal and external validation by assessing a model's performance in patients recruited at a later time point (temporal transportability) and in medical centers different from those used for model building (geographic transportability). Since this research takes 4 years to complete, it is paramount that we embark on a second prospective multi-site trial to accomplish these tasks as soon as possible. The Veterans Medical Programs Amendments of 1992 (PL 102-405) identified veterans with amputations as a special disability group and emphasized the importance for VHA to provide the highest quality of care. This year the VA Office of Patient Care Services approved and funded the development of a national amputation system of care with the goal of enhancing the quality and consistency of care. As noted above, there is considerable variability in decision making regarding amputation level. This is in part related to the combined uncertainty of an individual's constellation of medical, psychological, and social factors on their functional outcome. The proposed work in conjunction with the previously funded work will specifically result in a model of outcome prediction that can be used clinically. The tool will allow the preoperative prediction of outcome based upon an assessment of key variables. This will significantly reduce variability in health care practices, allow more effective prediction of functional outcome as a rehabilitation planning tool, and allow for more effective patient education and consent. These are all key issues that will assist the VA in its mission to enhance the clinical care of patients with amputation.

描述(由申请人提供)： 项目概述/摘要我们目前的前瞻性多点研究已经导致在经股(TF)、经胫骨(TT)和经跖骨(TM)截肢者中开发出一种可靠的预后模型，我们称之为AMPREDICT。AMPREDICT被开发用于手术前的治疗决策，通过将结果成功与基线人口统计、身体和心理社会措施相关联。拟议研究的最终目标是验证AMPREDICT，以便它可以被推荐用于以下目的的广泛临床应用：(1)为外科医生、康复团队和患者提供有关患者预后的信息；(2)协助外科医生、康复团队和患者计划最适当的截肢水平；(3)提供用于有效比较治疗和康复结果的客观工具；(4)协助临床医生和患者之间的沟通和信息交换；以及(5)协助退伍军人事务部的政策决策，以确保对每个患者的最佳护理水平做出合理判断。为了实现这一点，我们计划通过评估AMPREDICT预测模型在不同人群中的准确性来评估其性能，而不是它所在的人群。在AMPREDICT推荐广泛临床使用之前，这项研究是至关重要的。这项研究的主要目的是评估我们目前的预后模型(AMPREDICT)在预测同一机构中不同时间段(时间可迁移性)和不同机构(地理可迁移性)中TT和TM截肢者的身体和心理社会结果方面的表现，以便推荐广泛临床使用。 公共卫生相关性： 项目简介在美国，大约10%的大型截肢手术是在退伍军人事务部医学中心进行的。2003财政年度(FY)，DVA医院共实施了2600多例截肢手术。功能结局的主要决定因素之一是截肢水平的选择。与经胫骨水平截肢相比，经股水平截肢显著降低了获得独立活动和社区行走的可能性。选择最佳截肢水平是很复杂的。截肢越远，功能结果得到改善的可能性越大，但愈合率降低。治愈失败可能导致长时间或反复住院，需要额外的手术，其现有的风险是额外的发病率和死亡率。退伍军人事务部病人护理服务办公室最近一份题为《VHA中的下肢截肢；1997-2003财年》的报告显示了这种不一致。它比较了20家老牌综合服务网络(VISN)在TF/TT截肢率方面的差异。7例VISN患者接受的TF型截肢多于TT型截肢。报告显示，有VISN进行经股骨截肢的次数几乎是进行经胫骨截肢的两倍，而VISN执行经股骨截肢的次数是进行经胫骨截肢的一半。很明显，外科实践中存在着广泛的变异性。在过去的四年里，我们小组对与治疗“成功”相关的因素进行了第一次前瞻性研究，并开发了一种我们称为AMPREDICT的预后模型。这个稳健的预后模型考察了预测医疗和心理社会结果的基线人口、医疗、身体和心理社会风险因素。AMPREDICT的实施将为提供者提供一个宝贵的临床决策工具，帮助他们为患者确定合适的截肢水平。然而，在一个预后模型可以被推荐用于广泛的临床应用之前，它的性能需要被建立。这是通过时间和外部验证来实现的，方法是评估在稍后的时间点招募的患者的模型性能(时间可传输性)，以及不同于用于模型建立的医疗中心的模型的性能(地理可传输性)。由于这项研究需要4年的时间才能完成，因此我们必须着手进行第二次前瞻性多点试验，以尽快完成这些任务。1992年退伍军人医疗方案修正案(PL 102-405)将截肢退伍军人确定为特殊残疾群体，并强调了退伍军人管理局提供最高质量护理的重要性。今年，退伍军人事务部病人护理服务办公室批准并资助了国家截肢护理系统的发展，目的是提高护理的质量和一致性。如上所述，关于截肢水平的决策有相当大的变异性。这在一定程度上与个体的医学、心理和社会因素组合对其功能结果的不确定性有关。拟议的工作与之前资助的工作将特别产生一个可用于临床的结果预测模型。该工具将允许根据对关键变量的评估对结果进行术前预测。这将显著减少卫生保健实践中的可变性，允许更有效地预测作为康复计划工具的功能结果，并允许更有效地对患者进行教育和同意。这些都是有助于退伍军人管理局履行其使命的关键问题，即加强对截肢患者的临床护理。