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Kit Beobachtungsepidemiologie

Beobachtende Gesundheitsforschung: Präregistrierung, SAP, Codebuch, Regression, Target Trial Emulation, STROBE, TRIPOD+AI und STARD.

9 Vorlagen in 3 Schritten, in der Reihenfolge der Nutzung. Öffnen Sie eine Vorlage im Editor, füllen Sie sie aus und exportieren Sie sie als PDF, DOCX oder HTML.

Schritt 1

Planung

  1. Study Preregistration Template

    Standard

    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)

    Vollständig

    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)

    Vollständig

    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
Schritt 2

Methode und Muster

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

    Vollständig

    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)

    Vollständig

    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)

    Vollständig

    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)
Schritt 3

Dokumentation erstellen

  1. Observational Study Report Template (STROBE)

    Vollständig

    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)

    Vollständig

    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)

    Vollständig

    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)