In CTU-Bern/CTUtemplate: Example RStudio Project Templates

knitr::opts_chunk$set(echo = TRUE)

# create CLO file required by the Latex template
CTUtemplate::use_ubreportclo(
  # Personal info
  sign = params$author,
  email = params$email,
  job = params$job,
  # Project info
  projnum = params$projnum,
  projname = params$projname,
  # Report info
  version = params$version,
  reporttype = params$reportname
)

Administrative Information {-}

Project number r params$projnum Protocol version V1

\chapter{Study objective}

Primary objective

Describe study objective. The study objective will usually be defined according to: Patients: Which patients are included in the study? Interventions: Which are the intervention groups? Comparisons: Which are the control groups? Outcome: Which is the primary outcome?

Primary outcome

Description of primary outcome, including: Type of data (binary, ordinal, continuous, count, time-to-event) Time point of assessment * In case of continuous outcomes, the measurement scale/units of measurements

Hypothesis (if applicable)

Description of null and alternative hypothesis
Testing framework (e.g. superiority)

\chapter{Methods and assumptions}

Allocation ratio,
Type I and II error rate,
Effect measure, e.g. relative risk, difference in means
Minimal clinically relevant difference between the groups (or non-inferiority margin),
Assumptions about any further parameter that is used, e.g. standard deviation for continuous outcomes, baseline proportion/rate for binary/survival outcomes.
Any corrections for dropouts or withdrawals (if applicable),
Method or test used for the sample size calculation,
Statistics software used (unless standard test/method is used)