Department of Anesthesiology, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong, People's Republic of China.
Department of Thoracic Surgery, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong, People's Republic of China.
BMJ Open. 2023 Feb 10;13(2):e066815. doi: 10.1136/bmjopen-2022-066815.
Postoperative pulmonary complications (PPCs) occur after up to 60% of non-cardiac thoracic surgery (NCTS), especially for multimorbid elderly patients. Nevertheless, current risk prediction models for PPCs have major limitations regarding derivation and validation, and do not account for the specific risks of NCTS patients. Well-founded and externally validated models specific to elderly NCTS patients are warranted to inform consent and treatment decisions.
We will develop, internally and externally validate a multivariable risk model to predict 30-day PPCs in elderly NCTS patients. Our cohort will be generated in three study sites in southern China with a target population of approximately 1400 between October 2021 and December 2023. Candidate predictors have been selected based on published data, clinical expertise and epidemiological knowledge. Our model will be derived using the combination of multivariable logistic regression and bootstrapping technique to lessen predictors. The final model will be internally validated using bootstrapping validation technique and externally validated using data from different study sites. A parsimonious risk score will then be developed on the basis of beta estimates derived from the logistic model. Model performance will be evaluated using area under the receiver operating characteristic curve, max-rescaled Brier score and calibration slope. In exploratory analysis, we will also assess the net benefit of Probability of PPCs Associated with THoracic surgery in elderly patients score in the complete cohort using decision curve analysis.
Ethical approval has been obtained from the Institutional Review Board of the Affiliated Cancer Hospital and Institute of Guangzhou Medical University, the Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine and the University of Hongkong-Shenzhen Hospital, respectively. The final risk prediction model will be published in an appropriate journal and further disseminated as an online calculator or nomogram for clinical application. Approved and anonymised data will be shared.
ChiCTR2100051170.
非心脏胸外科手术（NCTS）后，多达 60%的患者会发生术后肺部并发症（PPCs），尤其是对于多病的老年患者。然而，目前用于 PPCs 的风险预测模型在推导和验证方面存在重大局限性，并且没有考虑到 NCTS 患者的特定风险。有必要为老年 NCTS 患者制定基于证据且经过外部验证的特定风险预测模型，以便为知情同意和治疗决策提供信息。
我们将开发一个多变量风险模型，用于预测老年 NCTS 患者的 30 天 PPCs，并进行内部和外部验证。我们的队列将在中国南方的三个研究地点产生，目标人群约为 1400 人，研究时间为 2021 年 10 月至 2023 年 12 月。候选预测因素是根据已发表的数据、临床专业知识和流行病学知识选择的。我们的模型将使用多变量逻辑回归和引导技术的组合来减少预测因素。最终模型将使用引导验证技术进行内部验证，并使用来自不同研究地点的数据进行外部验证。然后，将根据来自逻辑模型的β估计值开发一个简约的风险评分。使用接收者操作特征曲线下面积、最大缩放 Brier 评分和校准斜率来评估模型性能。在探索性分析中，我们还将使用决策曲线分析评估 Probability of PPCs Associated with THoracic surgery in elderly patients 评分在整个队列中的净收益。
广州医科大学附属肿瘤医院和研究所、广州中医药大学第二附属医院和香港中文大学深圳医院的机构审查委员会分别批准了该研究。最终的风险预测模型将发表在适当的期刊上，并进一步作为在线计算器或列线图传播，用于临床应用。批准和匿名的数据将被共享。
ChiCTR2100051170。
