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观察性流行病学套件

观察性健康研究：预注册、SAP、编码手册、回归、目标试验模拟、STROBE、TRIPOD+AI 与 STARD。

9 个模板，按使用顺序分为 3 步。在编辑器中打开任一模板，填写后可导出为 PDF、DOCX 或 HTML。

第 1 步

规划

  1. Study Preregistration Template

    标准

    Preregistration of hypotheses, design, sampling plan and stopping rule, variables, analysis plan, exclusions and deviations log

    OSF preregistration (concepts)

  2. Statistical Analysis Plan Template (Statistics, Thesis or Project)

    完整

    Statistical analysis plan for a thesis or project: estimands, hypotheses, sample size, primary model, pre-set assumption fallbacks, missing data, multiplicity, sensitivity, deviations log

    ICH E9(R1) estimand framework (name); Gamble et al. (2017) SAP content; Holm (1979); Rubin (1987); Borm et al. (2007)

  3. Variable Codebook Template (Statistics, Measurement Levels, R and Python)

    完整

    Research question to variables, measurement levels, variable roles with a causal sketch, codebook table, Likert and reverse coding, R and Python codebook checks

    Stevens (1946) scales of measurement; Velleman and Wilkinson (1993); Likert (1932); DDI codebook practice (name); NIST/SEMATECH e-Handbook
第 2 步

方法与模式

  1. Logistic Regression Method Card Template (Statistics, R and Python)

    完整

    Binary logistic regression: logit link, odds ratios, Wald vs likelihood-ratio tests, profile vs Wald CIs, predicted probabilities and marginal effects, classification metrics, calibration, separation and EPV, with R and Python

    Cox (1958); Nelder and Wedderburn (1972); Albert and Anderson (1984); Firth (1993); Hanley and McNeil (1982); Peduzzi et al. (1996); APA JARS-Quant (name)

  2. Count Regression Method Card Template (Statistics, Poisson and NB, R and Python)

    完整

    Poisson and negative binomial regression for counts: rate ratios, offsets for exposure, overdispersion check, quasi-Poisson, theta vs alpha, zero-inflation note, with R and Python

    Nelder and Wedderburn (1972); Lawless (1987); Lambert (1992); Cameron and Trivedi (2013); Venables and Ripley (2002) MASS; NIST/SEMATECH e-Handbook (public domain)

  3. Target Trial Emulation Protocol and Report Template (TARGET 2025)

    完整

    Target trial emulation: causal question, data sources, target trial vs emulation table, time zero, estimands, assumptions, weighting, bias checks, TARGET map

    TARGET 2025 (21 items; JAMA 2025;334(12):1084-1093; BMJ 2025;390:e087179)
第 3 步

编写文档

  1. Observational Study Report Template (STROBE)

    完整

    Cohort, case-control or cross-sectional report by STROBE topics: variables, bias, OR/RR formulas, adjusted estimates with CI

    STROBE; TARGET for target trial emulation

  2. Prediction Model Study Report Template (TRIPOD+AI)

    完整

    Clinical prediction or AI model development and evaluation report: data, outcome, predictors, sample size, fairness, calibration, net benefit, open science, TRIPOD+AI item map

    TRIPOD+AI (BMJ 2024), 27 items

  3. Diagnostic Accuracy Study Report Template (STARD 2015)

    完整

    Diagnostic accuracy study report: STARD 2015 items, intended use, test methods, flow diagram, 2x2 table, sensitivity, specificity, likelihood ratios

    STARD 2015 (30 items, BMJ 2015;351:h5527)