预测模型 | 临床预测模型开发checklist详解

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简介：近年来关于预测模型的文章很多，但很多相关研究都存在各种各样的不规范，也就是开发的模型成千上万，正能用的少之又少。关于那些 prognostic gene model就更不用说了，今天灌明天灌肯定是不行的。

前文我们已经对TRIPOD声明的内容即背景进行了介绍预测模型第3篇|你的预测模型文章报告是规范的吗？，本文对TRIPOD checklist-开发预测模型进行详细解读。

要发表高质量的临床预测模型研究，应该参考真正规范的报告模型，我们根据这一的一个checklist来帮助我们查缺补漏。绝知此事要躬行，这里白介素2整理阅读了来自 TRIPOD checklist文件，全文如下，如有不当之处，请诸位斧正。

标题-Title

1. Identify the study as developing and/or validating a multivariable prediction model, the target population, and the outcome to be predicted.

• 文章标题应该指出是开发一个多因素预测模型

• 指出目标人群

• 指出预测的结局

摘要-Abstrat

1. Provide a summary of objectives, study design, setting, participants, sample size, predictors, outcome, statistical analysis, results, and conclusions.

文章的摘要部分应该概括 目的，研究设计，纳入人群，样本量，预测因素，预测结局，统计分析，结果，文章结论 。一个好的摘要通常是简明扼要的，但又不缺失这些信息，在临床预测模型文章准备过程中应该按照这些核心元素去撰写。

前言-Introduction

3a. Explain the medical context (including whether diagnostic or prognostic) and rationale for developing or validating the multivariable prediction model, including references to existing models.

• 介绍医学背景，是诊断模型还是预后模型以及开发或验证多因素模型的理论基础，同时也应该说明该具体问题之前的其它预测模型的研究情况，是否已有前人研究，效果如何。

3b. Specify the objectives, including whether the study describes the development or validation of the model or both.

• 明确点明目的，说明是 开发还是 验证预测模型

方法学

数据来源-Source of data

4a. Describe the study design or source of data (e.g., randomized trial, cohort, or registry data), separately for the development and validation data sets, if applicable

• 描述 研究设计和 数据来源，分别描述开发集和验证集的数据来源是随机试验，队列，还是登记数据。

4b. Specify the key study dates, including start of accrual; end of accrual; and, if applicable, end of follow-up.

• 描述研究的关键日期

参与对象- Participants

5a. Specify key elements of the study setting (e.g., primary care, secondary care, general population) including number and location of centres.

5b. Describe eligibility criteria for participants.

5c. Give details of treatments received, if relevant.

• 描述研究关键的研究设定， Care， 中心的位置和数量

• 描述纳入人群的标准

• 必要时给出治疗信息

结局-Outcome

6a. Clearly define the outcome that is predicted by the prediction model, including how and when assessed.

6b. Report any actions to blind assessment of the outcome to be predicted.

• 明确定义预测模型预测的结局，应该指出是如何和何时进行评估的。

• 报告预测结局的盲法，如果有的话

预测因素-Predictors

7a. Clearly define all predictors used in developing or validating the multivariable prediction model, including how and when they were measured.

7b. Report any actions to blind assessment of predictors for the outcome and other predictors.

• 清楚的报告用以开发或者验证预测模型的预测因素，包括它们是何时以及如何测定的

• 报告预测因素的盲法，如果有的话

样本量-Sample size

1. Explain how the study size was arrived at.

• 说明样本量的大小

缺失数据-Missing data

1. Describe how missing data were handled (e.g., complete-case analysis, single imputation, multiple imputation) with details of any imputation method.

• 描述 缺失数据是如何处理的，比如完整案例分析，单纯插补， 多重插补方法。如有插补应该描述插补方法的细节。

统计方法-Statistical analysis methods

10a. Describe how predictors were handled in the analyses.

10b. Specify type of model, all model-building procedures (including any predictor selection), and method for internal validation.

10d. Specify all measures used to assess model performance and, if relevant, to compare multiple models.

• 描述 预测因素（变量）在分析中是如何处理的

• 指出模型的类型，完整的模型构建步骤（包括变量选择），以及内部验证的方法

• 指出用以评估模型表现的方法，如果相关的话，比较多个模型的表现

风险分组-Risk group

1. Provide details on how risk groups were created, if done.

• 如果模型进行了风险分组，应该提供风险分组是如何得出的

结果

参与对象

13a. Describe the flow of participants through the study, including the number of participants with and without the outcome and, if applicable, a summary of the follow-up time. A diagram may be helpful.

13b. Describe the characteristics of the participants (basic demographics, clinical features, available predictors), including the number of participants with missing data for predictors and outcome.

• 描述参与对象选择的流程，包括有结局，无结局的对象；包括对随访时间的概括；最好以图形的形式呈现

• 描述纳入人群的基线特征，临床特征，可以获得的预测变量，包括含有缺失数据的纳入人群

模型开发-Model development

14a. Specify the number of participants and outcome events in each analysis

14a. If done, report the unadjusted association between each candidate predictor and outcome.

• 指出每个分析中纳入人群的数目，结局发生的数目

• 必要时，报告潜在未校正的可能与结局相关的预测因素

模型的具体说明-Model specification

15a. Present the full prediction model to allow predictions for individuals (i.e., all regression coefficients, and model intercept or baseline survival at a given time point).

15b. Explain how to the use the prediction model.

• 完整的呈现模型的具体参数：例如回归系数，基线生存的时间点

• 解释模型如何使用

模型的性能-Model performance

1. Report performance measures (with CIs) for the prediction model.

• 报告预测模型性能的参数 （包括可信区间）

讨论

局限性-Limitations

1. Discuss any limitations of the study (such as  nonrepresentative sample, few events per predictor, missing data).

• 讨论研究的局限性 （例如样本的代表性局限，结局事件少，缺失数据等）

解释-Interpretation

19b. Give an overall interpretation of the results, considering objectives, limitations, and results from similar studies, and other relevant evidence.

• 整体的解释结果，考虑其它类似研究的目的，局限性，结果以及其它相关证据

启示-Implications

1. Discuss the potential clinical use of the model and implications for future research.

• 讨论模型的潜在临床应用价值和将来研究的方向

其它信息-Other information

补充信息-Supplementary information

1. Provide information about the availability of supplementary resources, such as study protocol, Web calculator, and data sets.

• 提供其它补充的信息，例如研究的步骤，网页版的计算器，数据集信息

资助信息-Funding

1. Give the source of funding and the role of the funders for the present study

• 给出基金来源及资助方在研究中的作用

参考文献

https://www.tripod-statement.org

TRIPOD checklist: Prediction model development