Outcomes Calculators for Informed Decision Making in Back Surgery

项目总结（见说明）： 了解手术受益和伤害风险的个体化可能性的患者更有可能做出与其目标和价值观一致的治疗选择，但患者在考虑背部手术时往往缺乏与这些决定相关的信息。该项目基于达特茅斯的临床研究人员和一个非营利消费者研究组织（消费者联盟）之间的独特合作，将开发基于网络的工具，以促进从复杂的 临床试验直接提供给医生和患者，应用个体化结果来改善常规临床实践。我们将为NlAMS资助的脊柱患者结局研究试验中研究的三种常见背痛诊断中的每一种开发基于网络的计算器。预测模型将在内部进行验证，并使用来自缅因州腰椎研究（MISS，8. Atlas，PI）和一项大型荷兰腰椎间盘突出症随机试验。 该研究的第一阶段将根据SPORT中2，427名背部和腿部疼痛患者的最新8年结局，开发并验证用于预测腰椎手术获益和风险的结局模型。拟议研究的第二阶段将使用结构化的产品开发过程的计算器接口。一个由医生和方法学家组成的专家小组将就信息架构和设计进行咨询。将使用患者和专家医生小组进行认知访谈和迭代网络开发，以告知设计和数据呈现的修订。该项目的第三阶段将在对参与SPORT中心的供应商及其考虑手术的患者进行调查时评估计算器，并对消费者联盟订户进行便利抽样，以评估其可用性，可理解性以及对考虑背部手术的患者决策的影响。在验证和评估阶段成功完成后，计算器将作为vveb应用程序免费发布。

PROJECT SUMMARY (See instructions): Patients who understand their individualized likelihood of benefits and risk of harms with surgery are more likely to make treatment choices that are consistent with their goals and values, but patients often lack information pertinent to these decisions when considering back surgery. This project, based on a unique collaboration between clinical researchers at Dartmouth and a non-profit consumer research organization (Consumers Union), will develop web-based tools to facilitate the transfer of scientific results from complex clinical trials directly to physicians and patients, applying individualized results to improve routine clinical practice. We will develop a web-based calculator for each of three common back pain diagnoses studied in the NlAMS-funded Spine Patient Outcomes Research Trial . Prediction models will be validated internally and with data from the Maine Lumbar Spine Study (MISS, 8. Atlas, PI) and a large Dutch lumbar herniated disc randomized trial. The first phase of the study will develop and validate outcomes models for predicting benefits and risks of lumbar spine surgery based on newly available 8-year outcomes for the 2,427 back and leg pain patients in SPORT. The second phase of the proposed research will use a structured product development process for the calculator interface. An expert panel of physicians and methodologists will be consulted concerning information architecture and design. Cognitive interviews and iterative web development using patients and expert physician panels will be used to inform revisions in design and data presentation. The third phase of the project will evaluate the calculator in a survey of providers and their patients considering surgery at participating SPORT centers and a convenience sample of Consumers Union subscribers to evaluate its usability, understandability, and impact on decision-making in patients considering back surgery. Following the successful completion of the validation and evaluation phases, the calculator will be freely disseminated as a vveb application.