Weiner Bradley K, Patel Rikin, Noble Phillip
Department of Orthopaedics, The Methodist Hospital, 6550 Fannin Street, Suite 2500, Houston, TX 77030, USA.
Spine J. 2008 Nov-Dec;8(6):959-67. doi: 10.1016/j.spinee.2007.11.007. Epub 2008 Feb 19.
Patient factors (diabetes, osteoporosis, cardiopulmonary problems, previous surgery, smoking, worker's compensation, litigation) and surgeon factors (operative experience, patient selection, technical skill, setting) are known to significantly impact outcomes of spinal surgery. The impact of these factors is difficult to assess clinically given the volume of patients required to obtain statistically significant information, the costs involved, and ethical/equipoise considerations. Computer simulation offers a viable and useful alternative.
To establish a computer simulation for randomized trials (randomized controlled clinical trials)/registries and to examine the impact of surgeon and patient factors on surgical outcomes.
Computer simulation of randomized controlled trials and nonrandomized trials (registries).
On the basis of an extensive review of the literature regarding surgical outcomes (lumbar disectomy and decompression) and patient/surgeon factors affecting such outcomes, hazard functions were developed to model the distribution of relative outcome as a function of the risk profile of individual patients and surgeons. An iterative algorithm was used to randomly or nonrandomly pair patients and surgeons to create simulated randomized controlled clinical trials/registries encompassing 10,000 performed procedures per run.
When fully randomized, outcomes were as expected with 80% of patients obtaining a satisfactory result. When the best surgeons were paired with the best patients, success rates approached 98%; and when the worst surgeons were paired with the worst patients, success rates dropped to 53%. Other nonrandom combinations were also assessed.
The computer simulation obtains expected outcomes for randomized controlled clinical trials and closely mirrors the range of outcomes seen in available case-series/registry data--a very useful model allowing assessment of the impact of patient/surgeon factors on surgical outcomes. Multiple patient/surgeon combinations are assessed and the implications of findings discussed.
已知患者因素（糖尿病、骨质疏松症、心肺问题、既往手术史、吸烟、工伤赔偿、诉讼）和外科医生因素（手术经验、患者选择、技术技能、手术环境）会显著影响脊柱手术的结果。鉴于获取具有统计学意义的信息所需的患者数量、涉及的成本以及伦理/均衡性考虑，这些因素的影响在临床上很难评估。计算机模拟提供了一种可行且有用的替代方法。
建立用于随机试验（随机对照临床试验）/登记处的计算机模拟，并研究外科医生和患者因素对手术结果的影响。
随机对照试验和非随机试验（登记处）的计算机模拟。
在广泛回顾有关手术结果（腰椎间盘切除术和减压术）以及影响此类结果的患者/外科医生因素的文献的基础上，开发了风险函数，以将相对结果的分布建模为个体患者和外科医生风险概况的函数。使用迭代算法随机或非随机地将患者和外科医生配对，以创建每次运行包含10000例手术的模拟随机对照临床试验/登记处。
完全随机分组时，结果符合预期，80%的患者获得满意结果。当最佳外科医生与最佳患者配对时，成功率接近98%；而当最差外科医生与最差患者配对时，成功率降至53%。还评估了其他非随机组合。
计算机模拟得出了随机对照临床试验的预期结果，并紧密反映了现有病例系列/登记处数据中的结果范围——这是一个非常有用的模型，可用于评估患者/外科医生因素对手术结果的影响。评估了多种患者/外科医生组合，并讨论了研究结果的意义。
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