## Summary

The Mediana R package uses the officer and flextable R packages to generate a Microsoft Word-based report that summarizes the results of Clinical Scenario Evaluation-based simulations.

The user can easily customize this simulation report by adding a description of the project as well as labels to each scenario, including data scenarios (sample size, outcome distribution parameters, design parameters) and analysis scenarios (multiplicity adjustment). The user can also customize the report’s structure, e.g., create sections and subsections within the report and specify how the rows will be sorted within each table.

In order to customize the report, the user has to use a PresentationModel object described below.

Once a PresentationModel object has been defined, the GenerateReport function can be called to generate a Clinical Scenario Evaluation report.

## Initialization

A presentation model can be initialized using the following command

Initialization with this command is highly recommended as it will simplify the process of adding related objects, e.g., the Project, Section, Subsection, Table, CustomLabel objects.

## Specific objects

Once the PresentationModel object has been initialized, specific objects can be added by simply using the ‘+’ operator as in data, analysis and evaluation models.

### Project object

#### Description

This object specifies a description of the project. The Project object is defined by three optional arguments:

• username defines the username to be included in the report (by default, the username is “[Unknown User]”).

• title defines the project’s in the report (the default value is “[Unknown title]”).

• description defines the project’s description (the default value is “[No description]”).

This information will be added in the report generated using the GenerateReport function.

A single object of the Project class can be added to an object of the PresentationModel class.

#### Examples

A simple Project object can be created as follows:

### Section object

#### Description

This object specifies the sections that will be created within the simulation report. A Section object is defined by a single argument:

• by defines the rules for setting up sections.

The by argument can contain several parameters from the following list:

• sample.size: a separate section will be created for each sample size.

• event: a separate section will be created for each event count.

• outcome.parameter: a separate section will be created for each outcome parameter scenario.

• design.parameter: a separate section will be created for each design parameter scenario.

• multiplicity.adjustment: a separate section will be created for each multiplicity adjustment scenario.

Note that, if a parameter is defined in the by argument, it must be defined only in this object (i.e., neither in the Subection object nor in the Table object).

A single object of the Section class can be added to an object of the PresentationModel class.

#### Examples

A Section object can be defined as follows:

Create a separate section within the report for each outcome parameter scenario:

Create a separate section for each unique combination of the sample size and outcome parameter scenarios:

### Subsection object

#### Description

This object specifies the rules for creating subsections within the simulation report. A Subsection object is defined by a single argument:

• by defines the rules for creating subsections.

The by argument can contain several parameters from the following list:

• sample.size: a separate subsection will be created for each sample size.

• event: a separate subsection will be created for each number of events.

• outcome.parameter: a separate subsection will be created for each outcome parameter scenario.

• design.parameter: a separate subsection will be created for each design parameter scenario.

• multiplicity.adjustment: a separate subsection will be created for each multiplicity adjustment scenario.

As before, if a parameter is defined in the by argument, it must be defined only in this object (i.e., neither in the Section object nor in the Table object).

A single object of the Subsection class can be added to an object of the PresentationModel class.

#### Examples

Subsection objects can be set up as follows:

Create a separate subsection for each sample size scenario:

Create a separate subsection for each unique combination of the sample size and outcome parameter scenarios:

### Table object

#### Description

This object specifies how the summary tables will be sorted within the report. A Table object is defined by a single argument:

• by defines how the tables of the report will be sorted.

The by argument can contain several parameters, the value must be contain in the following list:

• sample.size: the tables will be sorted by the sample size.

• event: the tables will be sorted by the number of events.

• outcome.parameter: the tables will be sorted by the outcome parameter scenario.

• design.parameter: the tables will be sorted by the design parameter scenario.

• multiplicity.adjustment: the tables will be sorted by the multiplicity adjustment scenario.

If a parameter is defined in the by argument it must be defined only in this object (i.e., neither in the Section object nor in the Subsection object).

A single object of class Table can be added to an object of class PresentationModel.

#### Examples

Examples of Table objects:

Create a summary table sorted by sample size scenarios:

Create a summary table sorted by sample size and outcome parameter scenarios:

### CustomLabel object

#### Description

This object specifies the labels that will be assigned to sets of parameter values or simulation scenarios. These labels will be used in the section and subsection titles of the Clinical Scenario Evaluation Report as well as in the summary tables. A CustomLabel object is defined by two arguments:

• param defines a parameter (scenario) to which the current set of labels will be assigned.

• label defines the label(s) to assign to each value of the parameter.

The param argument can contain several parameters from the following list:

• sample.size: labels will be applied to sample size values.

• event: labels will be applied to number of events values.

• outcome.parameter: labels will be applied to outcome parameter scenarios.

• design.parameter: labels will be applied to design parameter scenarios.

• multiplicity.adjustment: labels will be applied to multiplicity adjustment scenarios.

Several objects of the CustomLabel class can be added to an object of the PresentationModel class.

#### Examples

Examples of CustomLabel objects:

Assign a custom label to the sample size values:

Assign a custom label to the outcome parameter scenarios:

## GenerateReport function

### Description

The Clinical Scenario Evaluation Report is generated using the GenerateReport function. This function has four arguments:

• presentation.model defines a PresentationModel object.

• cse.result defines a CSE object returned by the CSE function.

• report.filename defines the filename of the Word-based report generated by this function.

• report.template defines a Word-based template (it is an optional argument).

The GenerateReport function requires the he officer and flextable R packages to generate a Word-based simulation report. Optionally, a custom template can be selected by defining report.template, this argument specifies the name of a Word document located in the working directory.

The Word-based simulation report is structured as follows:

1. GENERAL INFORMATION
1. PROJECT INFORMATION
2. SIMULATION PARAMETERS
2. DATA MODEL
1. DESIGN (if a Design object has been defined)
2. SAMPLE SIZE (or EVENT if an Event object has been defined)
3. OUTCOME DISTRIBUTION
4. DESIGN
3. ANALYSIS MODEL
1. TESTS
1. SECTION (if a Section object has been defined)
1. SUBSECTION (if a Subsection object has been defined)
This example illustrates the use of the GenerateReport function: