Towards standardized measurement of adverse events in spine surgery: conceptual model and pilot evaluation
Towards standardized measurement of adverse events in spine surgery: conceptual model and pilot evaluation
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DOI：
10.1186/1471-2474-7-53
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发表时间：
2006-06-20
影响因子：
2.3
通讯作者：
Goodkin, Robert
中科院分区：
文献类型：
--
作者：
Mirza, Sohail K.;Deyo, Richard A.;Goodkin, Robert
背景：独立于疗效，关于外科手术安全性的信息对于知情选择至关重要。我们寻求发展标准化的方法来描述脊柱手术的安全性，并将这些方法应用于研究腰椎手术。我们提出了一个用于评价脊柱手术安全性的概念模型，并描述了测量该模型主要成分的工具的开发：（1）通过明确的不良事件定义、确定模式、原因、严重程度或可预防性的标准来指定结果，以及（2）定量测量预测因子，例如患者因素、合并症、退行性脊柱疾病的严重程度，方法：我们创建了176例不良事件的操作定义，并建立了多种报告机制。我们开发了新的方法来量化不良事件的严重程度，腰椎退行性变和脊柱手术的侵入性。使用kappa统计和组内相关系数，我们评估了以下方面的一致性：4名评价者独立编码141例不良事件的病因、可预防性和严重性，2名观察者编码10例选定病例的腰椎退行性变化，2名研究者编码50例初始病例的手术侵入性。结果：在前六个月的前瞻性监测中，严格的每日医疗记录审查确定了我们记录的92.6%的不良事件，提供者的自愿报告确定了38.5%（外科医生报告18.3%，住院查房团队报告23.1%，会议讨论6.1%）。经过培训的观察者对141例不良事件的病因分类有相当的一致性（kappa = 0.35），但对4个特定类别的一致性很高（kappa >= 0.61）：技术错误、沟通失败、系统故障和无错误。可移植性评估具有中度一致性（平均加权kappa = 0.44）。当使用基于JCAHO Sentinel事件政策的量表时，不良事件严重度评级具有相当的一致性（平均加权kappa = 0.33），但在新的11分数值严重度量表（ICC = 0.74）上，严重度评级具有实质性一致性。腰椎退行性疾病严重程度评分（ICC = 0.98）和手术侵入性指数（ICC = 0.99）的评分者间一致性良好。结论：疾病严重程度和手术侵入性的综合指标可能允许开发脊柱手术不良事件的风险调整预测模型。不良事件和风险调整的标准措施也有助于脊柱器械的上市后监测、有效性研究和质量改进。
Background: Independent of efficacy, information on safety of surgical procedures is essential for informed choices. We seek to develop standardized methodology for describing the safety of spinal operations and apply these methods to study lumbar surgery. We present a conceptual model for evaluating the safety of spine surgery and describe development of tools to measure principal components of this model: ( 1) specifying outcome by explicit criteria for adverse event definition, mode of ascertainment, cause, severity, or preventability, and ( 2) quantitatively measuring predictors such as patient factors, comorbidity, severity of degenerative spine disease, and invasiveness of spine surgery.Methods: We created operational definitions for 176 adverse occurrences and established multiple mechanisms for reporting them. We developed new methods to quantify the severity of adverse occurrences, degeneration of lumbar spine, and invasiveness of spinal procedures. Using kappa statistics and intra-class correlation coefficients, we assessed agreement for the following: four reviewers independently coding etiology, preventability, and severity for 141 adverse occurrences, two observers coding lumbar spine degenerative changes in 10 selected cases, and two researchers coding invasiveness of surgery for 50 initial cases.Results: During the first six months of prospective surveillance, rigorous daily medical record reviews identified 92.6% of the adverse occurrences we recorded, and voluntary reports by providers identified 38.5% ( surgeons reported 18.3%, inpatient rounding team reported 23.1%, and conferences discussed 6.1%). Trained observers had fair agreement in classifying etiology of 141 adverse occurrences into 18 categories ( kappa = 0.35), but agreement was substantial ( kappa >= 0.61) for 4 specific categories: technical error, failure in communication, systems failure, and no error. Preventability assessment had moderate agreement ( mean weighted kappa = 0.44). Adverse occurrence severity rating had fair agreement ( mean weighted kappa = 0.33) when using a scale based on the JCAHO Sentinel Event Policy, but agreement was substantial for severity ratings on a new 11-point numerical severity scale (ICC = 0.74). There was excellent interrater agreement for a lumbar degenerative disease severity score ( ICC = 0.98) and an index of surgery invasiveness ( ICC = 0.99).Conclusion: Composite measures of disease severity and surgery invasiveness may allow development of risk-adjusted predictive models for adverse events in spine surgery. Standard measures of adverse events and risk adjustment may also facilitate post-marketing surveillance of spinal devices, effectiveness research, and quality improvement.