From f3ff79ac2336a6f9567f35e022f6f98d3781b679 Mon Sep 17 00:00:00 2001 From: Colleen McLaughlin Date: Mon, 10 Oct 2022 21:49:07 +0000 Subject: [PATCH 01/21] Working draft of data analysis vignette --- vignettes/DataAnalysis.Rmd | 73 ++++++++++++++++++++++++++++++++++++++ 1 file changed, 73 insertions(+) create mode 100644 vignettes/DataAnalysis.Rmd diff --git a/vignettes/DataAnalysis.Rmd b/vignettes/DataAnalysis.Rmd new file mode 100644 index 000000000..d15b693d5 --- /dev/null +++ b/vignettes/DataAnalysis.Rmd @@ -0,0 +1,73 @@ +--- +title: "Step-by-Step Analysis Workflow" +output: rmarkdown::html_vignette +vignette: > + %\VignetteIndexEntry{Step-by-Step Analysis Workflow} + %\VignetteEngine{knitr::rmarkdown} + %\VignetteEncoding{UTF-8} +--- + +```{r setup, include = FALSE} +library(gsm) +knitr::opts_chunk$set( + collapse = TRUE, + comment = "#>" +) +``` + +# Introduction + +This vignette walks users through the mechanics of the `Assess()` functions within the `{gsm}` package. The image below illustrates the supporting functions that are intrinsic to the workflow of the `Assess()` functions. + +![](vignettes/data-analysis.png) + +All of these functions will run automatically and sequentially when a user calls upon a given `Assess()` function. + +Each of these individual functions can also be run successfully outside of an `Assess()` function. + +For the purposes of this documentation, we will evaluate the input(s) and output(s) of each individual function to show the stepwise progression of how `Assess()` handles and processes data. + +## A Technical Demo - Step-By-Step + +We will use sample clinical data from the `{clindata}` package to run the Adverse Events (AE) Assessment, i.e., `AE_Assess()`. + +### 1. Create `dfInput` + +Generating input data is outside the scope of the assessment pipeline itself. However, the specifications for `dfInput` are designed to be simplistic enough so that this data frame can be generated from multiple clinical data standards. For example, users can run `Map_Raw()` or `Map_Adam()`, which will create `dfInput` from rawplus data or CDISC-compliant ADaM data, respectively. The [data pipeline](https://silver-potato-cfe8c2fb.pages.github.io/articles/DataPipeline.html) will be expanded upon in the future to incorporate data from various dashboards as well. + +The data frame `dfInput` needs to have one record per subject, with the following columns: + +- `SubjectID` = Subject Identifier +- `SiteID` = Site Identifier +- `StudyID` = Study Identifier +- `CustomGroupID` = Custom Group Identifier (in this example, set to Country Identifier) +- `Exposure` = Total Time on Treatment (measured in days; per subject) +- `Count` = Total Number of Incidences of the Event of Interest (in this example, the number of AEs reported; per subject) +- `Rate` = Rate of Event Incidence (calculated as `Exposure`/`Count`; per subject) + +```{r} +dfInput <- AE_Map_Raw( + dfs = list( + dfSUBJ = clindata::rawplus_dm, + dfAE = clindata::rawplus_ae + ) +) +``` + +```{r echo = FALSE} +dt(dfInput) +``` + +### 2. Create `dfTransformed` + +The data frame `dfTransformed` is derived from `dfInput` using one of the following functions (depending on the assessment being run): + +- `Transform_Rate()`: Calculates cumulative rate of the Event of Interest per site. In our example, the default metric for AEs is the number of AEs reported over time per site. +- `Transform_Count()`: Calculates cumulative count of the Event of Interest per site. This function is not used in `AE_Assess()` because the default metric for AEs is a rate. + +The resulting `dfTransformed` data frame using our example AE data will have the following columns: + +- `GroupID` = Group Identifier (in this example, Site ID) +- `Numerator` = Cumulative Count of the Incidence of the Event of Interest (in this example, number of AEs reported) +- `Denominator` = Cumulative Count of the Total Time on Treatment +- `Metric` = Rate of the Event of Interest (in this example, number of AEs reported over the course of treatment) From a1023760860e185c94701fdba7886e7d0f724680 Mon Sep 17 00:00:00 2001 From: Colleen McLaughlin <113617067+collleenmclaughlin@users.noreply.github.com> Date: Tue, 11 Oct 2022 14:00:26 -0400 Subject: [PATCH 02/21] Data Analysis Vignette Updated flowcharts to be used in data analysis vignette --- vignettes/data-analysis-ae-pd.PNG | Bin 0 -> 31043 bytes vignettes/data-analysis-consent-ie.PNG | Bin 0 -> 13515 bytes 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--git a/vignettes/DataAnalysis.Rmd b/vignettes/DataAnalysis.Rmd index d15b693d5..28982315a 100644 --- a/vignettes/DataAnalysis.Rmd +++ b/vignettes/DataAnalysis.Rmd @@ -8,18 +8,35 @@ vignette: > --- ```{r setup, include = FALSE} -library(gsm) knitr::opts_chunk$set( collapse = TRUE, comment = "#>" ) + +library(gsm) +library(tidyverse) +library(DT) +library(rmdformats) +library(gt) + +dt <- function(data){ + data %>% + DT::datatable( + extensions = 'FixedColumns', + options = list( + scrollX = TRUE, + fixedColumns = TRUE + ), + rownames = FALSE + ) +} ``` # Introduction -This vignette walks users through the mechanics of the `Assess()` functions within the `{gsm}` package. The image below illustrates the supporting functions that are intrinsic to the workflow of the `Assess()` functions. +This vignette walks users through the mechanics of the `Assess()` functions within the `{gsm}` package, which leverages Key Risk Indicators (KRIs) and thresholds to conduct study-level and site-level Risk Based Monitoring for clinical trials. The `Assess()` functions provide data frames, visualization, and metadata to be used in reporting and error checking. The image below illustrates the supporting functions that are intrinsic to the workflow of the `Assess()` functions. -![](vignettes/data-analysis.png) +![](data-analysis.PNG) All of these functions will run automatically and sequentially when a user calls upon a given `Assess()` function. @@ -27,13 +44,15 @@ Each of these individual functions can also be run successfully outside of an `A For the purposes of this documentation, we will evaluate the input(s) and output(s) of each individual function to show the stepwise progression of how `Assess()` handles and processes data. +------------------------------------------------------------------------ + ## A Technical Demo - Step-By-Step We will use sample clinical data from the `{clindata}` package to run the Adverse Events (AE) Assessment, i.e., `AE_Assess()`. ### 1. Create `dfInput` -Generating input data is outside the scope of the assessment pipeline itself. However, the specifications for `dfInput` are designed to be simplistic enough so that this data frame can be generated from multiple clinical data standards. For example, users can run `Map_Raw()` or `Map_Adam()`, which will create `dfInput` from rawplus data or CDISC-compliant ADaM data, respectively. The [data pipeline](https://silver-potato-cfe8c2fb.pages.github.io/articles/DataPipeline.html) will be expanded upon in the future to incorporate data from various dashboards as well. +Generating input data is outside the scope of the assessment pipeline itself. However, the specifications for `dfInput` are designed to be flexible enough so that this data frame can be generated from multiple clinical data standards. For example, users can run the `Map_Raw()` or `Map_Adam()` functions, which will create `dfInput` from Raw+ data or CDISC-compliant ADaM data, respectively. The [data pipeline](https://silver-potato-cfe8c2fb.pages.github.io/articles/DataPipeline.html) will be expanded upon in the future to incorporate data from various dashboards as well. The data frame `dfInput` needs to have one record per subject, with the following columns: @@ -58,16 +77,145 @@ dfInput <- AE_Map_Raw( dt(dfInput) ``` +------------------------------------------------------------------------ + ### 2. Create `dfTransformed` The data frame `dfTransformed` is derived from `dfInput` using one of the following functions (depending on the assessment being run): -- `Transform_Rate()`: Calculates cumulative rate of the Event of Interest per site. In our example, the default metric for AEs is the number of AEs reported over time per site. +- `Transform_Rate()`: Calculates cumulative rate of the Event of Interest per site. In our example, the default metric for AEs is the number of AEs reported over the course of treatment per site. - `Transform_Count()`: Calculates cumulative count of the Event of Interest per site. This function is not used in `AE_Assess()` because the default metric for AEs is a rate. -The resulting `dfTransformed` data frame using our example AE data will have the following columns: +The resulting `dfTransformed` data frame will contain site-level transformed data, including KRI calculation. Using our example AE data, `dfTransformed` contains the following columns: + +- `GroupID` = Group Identifier (i.e., Site ID) +- `Numerator` = Cumulative Count of Incidence of the Event of Interest (in this example, number of AEs reported) +- `Denominator` = Cumulative Count of the Total Time on Treatment (in days) +- `Metric` = Rate of Event of Interest (in this example, number of AEs reported over the course of treatment in days) + +```{r} +dfTransformed <- Transform_Rate( + dfInput, + strNumeratorCol = "Count", + strDenominatorCol = "Exposure" +) +``` + +```{r, echo = FALSE} +dt(dfTransformed) +``` + +------------------------------------------------------------------------ + +### 3. Create `dfAnalyzed` + +The data frame `dfAnalyzed` is derived from `dfTransformed` using one of the following functions built from a specific statistical model (depending on the assessment being run): + +- `Analyze_Fisher()`: Uses Fisher's Exact Test to determine if there are nonrandom associations between a site and a given KRI +- `Analyze_Identity()`: Used in the data pipeline between `Transform()` and `Flag()` functions to rename KRI and Score columns +- `Analyze_Poisson()`: Uses a Poisson model to describe the distribution of events in the overall site population, i.e., determine how many times an event is likely to occur at a site over a specified period of time + +The resulting `dfAnalyzed` data frame will contain site-level analysis results data. The Poisson model is the default analysis function for AE data, so using our example AE data, `dfAnalyzed` contains the following columns: + +- `GroupID` = Group Identifier (i.e., Site ID) +- `Numerator` = Cumulative Count of Incidence of the Event of Interest (in this example, number of AEs reported); Carried from `dfTransformed` +- `Denominator` = Cumulative Count of the Total Time on Treatment (in days); Carried from `dfTransformed` +- `Metric` = Rate of Event of Interest (in this example, number of AEs reported over the course of treatment in days); Carried from `dfTransformed` +- `Score` = Calculated Residual (per site) +- `PredictedCount` = Calculated Predicted Count (per site) + +```{r} +dfAnalyzed <- Analyze_Poisson(dfTransformed) +``` + +```{r, echo = FALSE} +dt(dfAnalyzed) +``` + +------------------------------------------------------------------------ + +### 4. Create `dfFlagged` + +The data frame `dfFlagged` is derived from `dfAnalyzed` using one of the following functions (depending on the assessment and the specific statistical model that was run): + +- `Flag_Fisher()`: Default flagging function when `Analyze_Fisher()` function is used for an assessment +- `Flag_Poisson()`: Default flagging function when `Analyze_Poisson()` function is used for an assessment +- `Flag()`: Default flagging function when `Analyze_Identity()` function is used for an assessment + +The resulting `dfFlagged` data frame will contain site-level analysis results data with flagging incorporated based on a pre-specified statistical threshold to highlight possible outliers. The default threshold for the AE Poisson model is (-7, -5, 5, 7), so using our example AE data, `dfFlagged` contains the following columns: + +- `GroupID` = Group Identifier (i.e., Site ID) +- `Numerator` = Cumulative Count of Incidence of the Event of Interest (in this example, number of AEs reported); Carried from `dfAnalyzed` +- `Denominator` = Cumulative Count of the Total Time on Treatment (in days); Carried from `dfAnalyzed` +- `Metric` = Rate of Event of Interest (in this example, number of AEs reported over the course of treatment in days); Carried from `dfAnalyzed` +- `Score` = Calculated Residual (per site); Carried from `dfAnalyzed` +- `PredictedCount` = Calculated Predicted Count (per site); Carried from `dfAnalyzed` +- `Flag` = Flag Indicating Possible Statistical Outliers + +```{r} +dfFlagged <- Flag_Poisson(dfAnalyzed, vThreshold = c(-7, -5, 5, 7)) +``` + +```{r, echo = FALSE} +dt(dfFlagged) +``` + +------------------------------------------------------------------------ + +### 5. Create `dfSummary` + +The data frame `dfSummary` is derived from `dfFlagged` using the `Summarize()` function. The resulting `dfSummary` data frame will contain the most relevant columns from `dfFlagged` with data sorted in a meaningful way to provide a concise overview of the assessment. Flagged sites will appear earlier than unflagged sites, with the more "extreme" outliers displayed first. These columns include: + +- `GroupID` = Group Identifier (i.e., Site ID) +- `Metric` = Rate of Event of Interest (in this example, number of AEs reported over the course of treatment in days) +- `Score` = Calculated Residual (per site) +- `Flag` = Flag Indicating Possible Statistical Outliers + +```{r} +dfSummary <- Summarize(dfFlagged) +``` + +```{r, echo = FALSE} +dt(dfSummary) +``` + +------------------------------------------------------------------------ + +### 6. Data Visualization + +Data visualizations are built into each `Assess()` function/KRI using the following functions: + +- `Visualize_Scatter`: Creates scatterplot of Total Exposure (days, log scale) vs Total Incidence of Event of Interest (linear scale); Each data point represents one site; Outliers are plotted in red and the associated site label is present; Only created when statistical method is **not** defined as `identity` +- `Visualize_Score`: Provides a standard visualization for Score or KRI +- `Visualize_Workflow`: Provides a flowchart with a high-level overview of the data pipeline for a given assessment + +For an AE assessment, a scatterplot is created using `dfTransformed` to define bounds and `dfFlagged` to plot the data. Using our example AE data, we see the following scatterplot: + +```{r} +dfBounds <- Analyze_Poisson_PredictBounds(dfTransformed, vThreshold = c(-8, 8)) + +chart <- Visualize_Scatter(dfFlagged, dfBounds) +``` + +```{r, echo = FALSE} +chart +``` + +------------------------------------------------------------------------ + +# Recap + +- `dfInput` used as original input; Can be created using `Map_Raw()` or `Map_Adam()`, if needed +- `dfTransformed` created from `dfInput` using `Transform_Count()` or `Transform_Rate()` +- `dfAnalyzed` created from `dfTransformed` using `Analyze_Poisson()`, `Analyze_Fisher()`, or `Analyze_Identity()` +- `dfFlagged` created from `dfAnalyzed` using `Flag_Poisson()`, `Flag_Fisher()`, or `Flag()` +- `dfSummary` created from `dfFlagged` using `Summarize()` +- Visualizations created from `dfTransformed` and `dfFlagged` + +What statistical models are available for each assessment? + +- Adverse Events (AE) and Protocol Deviations (PD): **Poisson or Identity** +- Subject Consent (Consent) and Inclusion/Exclusion (IE) Criteria: **Identity** +- Subject Disposition (Disp) and Laboratory (LB) Results: **Fisher or Identity** -- `GroupID` = Group Identifier (in this example, Site ID) -- `Numerator` = Cumulative Count of the Incidence of the Event of Interest (in this example, number of AEs reported) -- `Denominator` = Cumulative Count of the Total Time on Treatment -- `Metric` = Rate of the Event of Interest (in this example, number of AEs reported over the course of treatment) +![](data-analysis-combined.PNG) From 1a61057657c0e04c5286d394a022d92363d811ac Mon Sep 17 00:00:00 2001 From: Colleen McLaughlin Date: Tue, 11 Oct 2022 19:56:54 +0000 Subject: [PATCH 08/21] Minor updates --- vignettes/DataAnalysis.Rmd | 6 +++--- 1 file changed, 3 insertions(+), 3 deletions(-) diff --git a/vignettes/DataAnalysis.Rmd b/vignettes/DataAnalysis.Rmd index 28982315a..db5e4b4fb 100644 --- a/vignettes/DataAnalysis.Rmd +++ b/vignettes/DataAnalysis.Rmd @@ -34,7 +34,7 @@ dt <- function(data){ # Introduction -This vignette walks users through the mechanics of the `Assess()` functions within the `{gsm}` package, which leverages Key Risk Indicators (KRIs) and thresholds to conduct study-level and site-level Risk Based Monitoring for clinical trials. The `Assess()` functions provide data frames, visualization, and metadata to be used in reporting and error checking. The image below illustrates the supporting functions that are intrinsic to the workflow of the `Assess()` functions. +This vignette walks users through the mechanics of the `Assess()` functions within the `{gsm}` package. `{gsm}` leverages Key Risk Indicators (KRIs) and thresholds to conduct study-level and site-level Risk Based Monitoring for clinical trials. The `Assess()` functions provide data frames, visualization, and metadata to be used in reporting and error checking at clinical sites. The image below illustrates the supporting functions that are intrinsic to the workflow of the `Assess()` functions. ![](data-analysis.PNG) @@ -59,7 +59,7 @@ The data frame `dfInput` needs to have one record per subject, with the followin - `SubjectID` = Subject Identifier - `SiteID` = Site Identifier - `StudyID` = Study Identifier -- `CustomGroupID` = Custom Group Identifier (in this example, set to Country Identifier) +- `CustomGroupID` = Custom Group Identifier (in this example, set to Country ID) - `Exposure` = Total Time on Treatment (measured in days; per subject) - `Count` = Total Number of Incidences of the Event of Interest (in this example, the number of AEs reported; per subject) - `Rate` = Rate of Event Incidence (calculated as `Exposure`/`Count`; per subject) @@ -88,7 +88,7 @@ The data frame `dfTransformed` is derived from `dfInput` using one of the follow The resulting `dfTransformed` data frame will contain site-level transformed data, including KRI calculation. Using our example AE data, `dfTransformed` contains the following columns: -- `GroupID` = Group Identifier (i.e., Site ID) +- `GroupID` = Group Identifier (default is Site ID) - `Numerator` = Cumulative Count of Incidence of the Event of Interest (in this example, number of AEs reported) - `Denominator` = Cumulative Count of the Total Time on Treatment (in days) - `Metric` = Rate of Event of Interest (in this example, number of AEs reported over the course of treatment in days) From 97d8c79fd955577ec5a6fd64d7cdae097ce7fdb5 Mon Sep 17 00:00:00 2001 From: Colleen McLaughlin Date: Tue, 11 Oct 2022 21:45:31 +0000 Subject: [PATCH 09/21] Minor updates to V01 --- vignettes/DataAnalysis.Rmd | 60 +++++++++++++++++++------------------- 1 file changed, 30 insertions(+), 30 deletions(-) diff --git a/vignettes/DataAnalysis.Rmd b/vignettes/DataAnalysis.Rmd index db5e4b4fb..97dbe3c40 100644 --- a/vignettes/DataAnalysis.Rmd +++ b/vignettes/DataAnalysis.Rmd @@ -34,7 +34,7 @@ dt <- function(data){ # Introduction -This vignette walks users through the mechanics of the `Assess()` functions within the `{gsm}` package. `{gsm}` leverages Key Risk Indicators (KRIs) and thresholds to conduct study-level and site-level Risk Based Monitoring for clinical trials. The `Assess()` functions provide data frames, visualization, and metadata to be used in reporting and error checking at clinical sites. The image below illustrates the supporting functions that are intrinsic to the workflow of the `Assess()` functions. +This vignette walks users through the mechanics of the `Assess()` functions within the `{gsm}` package. `{gsm}` leverages Key Risk Indicators (KRIs) and thresholds to conduct study-level and site-level Risk Based Monitoring for clinical trials. The `Assess()` functions provide data frames, visualization, and metadata to be used in reporting and error checking at clinical sites. The image below illustrates the supporting functions that feed into the workflow of the `Assess()` functions. ![](data-analysis.PNG) @@ -52,7 +52,7 @@ We will use sample clinical data from the `{clindata}` package to run the Advers ### 1. Create `dfInput` -Generating input data is outside the scope of the assessment pipeline itself. However, the specifications for `dfInput` are designed to be flexible enough so that this data frame can be generated from multiple clinical data standards. For example, users can run the `Map_Raw()` or `Map_Adam()` functions, which will create `dfInput` from Raw+ data or CDISC-compliant ADaM data, respectively. The [data pipeline](https://silver-potato-cfe8c2fb.pages.github.io/articles/DataPipeline.html) will be expanded upon in the future to incorporate data from various dashboards as well. +Generating input data is outside the scope of the assessment pipeline itself. However, the specifications for `dfInput` are designed to be flexible enough so that this data frame can be generated from multiple clinical data standards. For example, users can run the `Map_Raw()` or `Map_Adam()` functions, which will create `dfInput` from Raw+ data or CDISC-compliant ADaM data, respectively. The [`{gsm}` data pipeline](https://silver-potato-cfe8c2fb.pages.github.io/articles/DataPipeline.html) will be expanded upon in the future to incorporate data from various dashboards as well. The data frame `dfInput` needs to have one record per subject, with the following columns: @@ -61,7 +61,7 @@ The data frame `dfInput` needs to have one record per subject, with the followin - `StudyID` = Study Identifier - `CustomGroupID` = Custom Group Identifier (in this example, set to Country ID) - `Exposure` = Total Time on Treatment (measured in days; per subject) -- `Count` = Total Number of Incidences of the Event of Interest (in this example, the number of AEs reported; per subject) +- `Count` = Total Number of Event(s) of Interest (in this example, the number of AEs reported; per subject) - `Rate` = Rate of Event Incidence (calculated as `Exposure`/`Count`; per subject) ```{r} @@ -83,15 +83,15 @@ dt(dfInput) The data frame `dfTransformed` is derived from `dfInput` using one of the following functions (depending on the assessment being run): -- `Transform_Rate()`: Calculates cumulative rate of the Event of Interest per site. In our example, the default metric for AEs is the number of AEs reported over the course of treatment per site. -- `Transform_Count()`: Calculates cumulative count of the Event of Interest per site. This function is not used in `AE_Assess()` because the default metric for AEs is a rate. +- `Transform_Rate()`: Calculates cumulative rate of Event(s) of Interest per site. In our example, the default metric for AEs is the number of AEs reported over the course of treatment per site. +- `Transform_Count()`: Calculates cumulative numer of Event(s) of Interest per site. *This function is not used in `AE_Assess()` because the default metric for AEs is a rate.* The resulting `dfTransformed` data frame will contain site-level transformed data, including KRI calculation. Using our example AE data, `dfTransformed` contains the following columns: - `GroupID` = Group Identifier (default is Site ID) -- `Numerator` = Cumulative Count of Incidence of the Event of Interest (in this example, number of AEs reported) -- `Denominator` = Cumulative Count of the Total Time on Treatment (in days) -- `Metric` = Rate of Event of Interest (in this example, number of AEs reported over the course of treatment in days) +- `Numerator` = Cumulative Number of Event(s) of Interest (in this example, number of AEs reported across subjects) +- `Denominator` = Cumulative Time on Treatment (in days, across subjects) +- `Metric` = Rate of Event(s) of Interest (in this example, number of AEs reported over the course of treatment in days) ```{r} dfTransformed <- Transform_Rate( @@ -109,18 +109,18 @@ dt(dfTransformed) ### 3. Create `dfAnalyzed` -The data frame `dfAnalyzed` is derived from `dfTransformed` using one of the following functions built from a specific statistical model (depending on the assessment being run): +The data frame `dfAnalyzed` is derived from `dfTransformed` using one of the following functions, which were built from a specific statistical model (depending on the assessment being run): -- `Analyze_Fisher()`: Uses Fisher's Exact Test to determine if there are nonrandom associations between a site and a given KRI +- `Analyze_Fisher()`: Uses Fisher's Exact Test to determine if there are non-random associations between a site and a given KRI - `Analyze_Identity()`: Used in the data pipeline between `Transform()` and `Flag()` functions to rename KRI and Score columns -- `Analyze_Poisson()`: Uses a Poisson model to describe the distribution of events in the overall site population, i.e., determine how many times an event is likely to occur at a site over a specified period of time +- `Analyze_Poisson()`: Uses a Poisson model to describe the distribution of events in the overall site population, i.e., determine how many times an event is likely to occur at a site over a specified treatment period The resulting `dfAnalyzed` data frame will contain site-level analysis results data. The Poisson model is the default analysis function for AE data, so using our example AE data, `dfAnalyzed` contains the following columns: -- `GroupID` = Group Identifier (i.e., Site ID) -- `Numerator` = Cumulative Count of Incidence of the Event of Interest (in this example, number of AEs reported); Carried from `dfTransformed` -- `Denominator` = Cumulative Count of the Total Time on Treatment (in days); Carried from `dfTransformed` -- `Metric` = Rate of Event of Interest (in this example, number of AEs reported over the course of treatment in days); Carried from `dfTransformed` +- `GroupID` = Group Identifier (default is Site ID) +- `Numerator` = Cumulative Number of Event(s) of Interest (in this example, number of AEs reported across subjects); Carried from `dfTransformed` +- `Denominator` = Cumulative Time on Treatment (in days, across subjects); Carried from `dfTransformed` +- `Metric` = Rate of Event(s) of Interest (in this example, number of AEs reported over the course of treatment in days); Carried from `dfTransformed` - `Score` = Calculated Residual (per site) - `PredictedCount` = Calculated Predicted Count (per site) @@ -138,19 +138,19 @@ dt(dfAnalyzed) The data frame `dfFlagged` is derived from `dfAnalyzed` using one of the following functions (depending on the assessment and the specific statistical model that was run): -- `Flag_Fisher()`: Default flagging function when `Analyze_Fisher()` function is used for an assessment -- `Flag_Poisson()`: Default flagging function when `Analyze_Poisson()` function is used for an assessment -- `Flag()`: Default flagging function when `Analyze_Identity()` function is used for an assessment +- `Flag_Fisher()`: Default flagging function when `Analyze_Fisher()` is used for an assessment +- `Flag_Poisson()`: Default flagging function when `Analyze_Poisson()` is used for an assessment +- `Flag()`: Default flagging function when `Analyze_Identity()` is used for an assessment -The resulting `dfFlagged` data frame will contain site-level analysis results data with flagging incorporated based on a pre-specified statistical threshold to highlight possible outliers. The default threshold for the AE Poisson model is (-7, -5, 5, 7), so using our example AE data, `dfFlagged` contains the following columns: +The resulting `dfFlagged` data frame will contain site-level analysis results data with flagging incorporated based on a pre-specified statistical threshold to highlight possible outliers. The default threshold for the AE Poisson model is (-7, -5, 5, 7) based on the available literature, so using our example AE data, `dfFlagged` contains the following columns: -- `GroupID` = Group Identifier (i.e., Site ID) -- `Numerator` = Cumulative Count of Incidence of the Event of Interest (in this example, number of AEs reported); Carried from `dfAnalyzed` -- `Denominator` = Cumulative Count of the Total Time on Treatment (in days); Carried from `dfAnalyzed` -- `Metric` = Rate of Event of Interest (in this example, number of AEs reported over the course of treatment in days); Carried from `dfAnalyzed` +- `GroupID` = Group Identifier (default is Site ID) +- `Numerator` = Cumulative Number of Event(s) of Interest (in this example, number of AEs reported across subjects); Carried from `dfAnalyzed` +- `Denominator` = Cumulative Time on Treatment (in days, across subjects); Carried from `dfAnalyzed` +- `Metric` = Rate of Event(s) of Interest (in this example, number of AEs reported over the course of treatment in days); Carried from `dfAnalyzed` - `Score` = Calculated Residual (per site); Carried from `dfAnalyzed` - `PredictedCount` = Calculated Predicted Count (per site); Carried from `dfAnalyzed` -- `Flag` = Flag Indicating Possible Statistical Outliers +- `Flag` = Flag Indicating Possible Statistical Outliers; Valid values for this variable include -2, -1, 0, 1, and 2, which determine the "extremeness" of the outlier. -2 and 2 represent more extreme outliers, -1 and 1 represent less extreme outliers, and 0 represents a non-outlier. ```{r} dfFlagged <- Flag_Poisson(dfAnalyzed, vThreshold = c(-7, -5, 5, 7)) @@ -164,12 +164,12 @@ dt(dfFlagged) ### 5. Create `dfSummary` -The data frame `dfSummary` is derived from `dfFlagged` using the `Summarize()` function. The resulting `dfSummary` data frame will contain the most relevant columns from `dfFlagged` with data sorted in a meaningful way to provide a concise overview of the assessment. Flagged sites will appear earlier than unflagged sites, with the more "extreme" outliers displayed first. These columns include: +The data frame `dfSummary` is derived from `dfFlagged` using the `Summarize()` function. The resulting `dfSummary` data frame will contain the most relevant columns from `dfFlagged` with data sorted in a meaningful way to provide a concise overview of the assessment. Flagged sites will sort earlier than non-flagged sites, with the more "extreme" outliers displayed first. The columns in `dfSummary` include: -- `GroupID` = Group Identifier (i.e., Site ID) -- `Metric` = Rate of Event of Interest (in this example, number of AEs reported over the course of treatment in days) +- `GroupID` = Group Identifier (default is Site ID) +- `Metric` = Rate of Event(s) of Interest (in this example, number of AEs reported over the course of treatment in days) - `Score` = Calculated Residual (per site) -- `Flag` = Flag Indicating Possible Statistical Outliers +- `Flag` = Flag Indicating Possible Statistical Outliers; Valid values for this variable include -2, -1, 0, 1, and 2, which determine the "extremeness" of the outlier. -2 and 2 represent more extreme outliers, -1 and 1 represent less extreme outliers, and 0 represents a non-outlier. ```{r} dfSummary <- Summarize(dfFlagged) @@ -185,11 +185,11 @@ dt(dfSummary) Data visualizations are built into each `Assess()` function/KRI using the following functions: -- `Visualize_Scatter`: Creates scatterplot of Total Exposure (days, log scale) vs Total Incidence of Event of Interest (linear scale); Each data point represents one site; Outliers are plotted in red and the associated site label is present; Only created when statistical method is **not** defined as `identity` +- `Visualize_Scatter`: Creates scatter plot of Total Exposure (in days, on log scale) vs Total Number of Event(s) of Interest (on linear scale). Each data point represents one site. Outliers are plotted in red with the site label attached. This plot is only created when statistical method is **not** defined as `identity`. - `Visualize_Score`: Provides a standard visualization for Score or KRI - `Visualize_Workflow`: Provides a flowchart with a high-level overview of the data pipeline for a given assessment -For an AE assessment, a scatterplot is created using `dfTransformed` to define bounds and `dfFlagged` to plot the data. Using our example AE data, we see the following scatterplot: +For an AE assessment, a scatter plot is created using `dfTransformed` to define bounds and `dfFlagged` to plot the data. Using our example AE data, we see the following scatter plot: ```{r} dfBounds <- Analyze_Poisson_PredictBounds(dfTransformed, vThreshold = c(-8, 8)) From 90ad9394724700f5e6135e4511ed2362dafa9cdf Mon Sep 17 00:00:00 2001 From: Colleen McLaughlin <113617067+collleenmclaughlin@users.noreply.github.com> Date: Thu, 13 Oct 2022 15:31:56 -0400 Subject: [PATCH 10/21] Update vignettes/DataAnalysis.Rmd Co-authored-by: Matt Roumaya <40671730+mattroumaya@users.noreply.github.com> --- vignettes/DataAnalysis.Rmd | 2 +- 1 file changed, 1 insertion(+), 1 deletion(-) diff --git a/vignettes/DataAnalysis.Rmd b/vignettes/DataAnalysis.Rmd index 97dbe3c40..cea6a114f 100644 --- a/vignettes/DataAnalysis.Rmd +++ b/vignettes/DataAnalysis.Rmd @@ -36,7 +36,7 @@ dt <- function(data){ This vignette walks users through the mechanics of the `Assess()` functions within the `{gsm}` package. `{gsm}` leverages Key Risk Indicators (KRIs) and thresholds to conduct study-level and site-level Risk Based Monitoring for clinical trials. The `Assess()` functions provide data frames, visualization, and metadata to be used in reporting and error checking at clinical sites. The image below illustrates the supporting functions that feed into the workflow of the `Assess()` functions. -![](data-analysis.PNG) +![](data-analysis.PNG){width=100%} All of these functions will run automatically and sequentially when a user calls upon a given `Assess()` function. From 560b6202ccd0f591c8c4b55d17aa0d9ee8efa2be Mon Sep 17 00:00:00 2001 From: Colleen McLaughlin <113617067+collleenmclaughlin@users.noreply.github.com> Date: Thu, 13 Oct 2022 15:32:30 -0400 Subject: [PATCH 11/21] Update vignettes/DataAnalysis.Rmd Co-authored-by: Matt Roumaya <40671730+mattroumaya@users.noreply.github.com> --- vignettes/DataAnalysis.Rmd | 2 +- 1 file changed, 1 insertion(+), 1 deletion(-) diff --git a/vignettes/DataAnalysis.Rmd b/vignettes/DataAnalysis.Rmd index cea6a114f..aac82ae26 100644 --- a/vignettes/DataAnalysis.Rmd +++ b/vignettes/DataAnalysis.Rmd @@ -40,7 +40,7 @@ This vignette walks users through the mechanics of the `Assess()` functions with All of these functions will run automatically and sequentially when a user calls upon a given `Assess()` function. -Each of these individual functions can also be run successfully outside of an `Assess()` function. +Each of these individual functions can also be run independently outside of an `Assess()` function. For the purposes of this documentation, we will evaluate the input(s) and output(s) of each individual function to show the stepwise progression of how `Assess()` handles and processes data. From 04e8d48a4cff6b08dccf2dbf3e5f7e8f35626e59 Mon Sep 17 00:00:00 2001 From: Colleen McLaughlin <113617067+collleenmclaughlin@users.noreply.github.com> Date: Thu, 13 Oct 2022 15:32:48 -0400 Subject: [PATCH 12/21] Update vignettes/DataAnalysis.Rmd Co-authored-by: Matt Roumaya <40671730+mattroumaya@users.noreply.github.com> --- vignettes/DataAnalysis.Rmd | 2 +- 1 file changed, 1 insertion(+), 1 deletion(-) diff --git a/vignettes/DataAnalysis.Rmd b/vignettes/DataAnalysis.Rmd index aac82ae26..6d8365691 100644 --- a/vignettes/DataAnalysis.Rmd +++ b/vignettes/DataAnalysis.Rmd @@ -54,7 +54,7 @@ We will use sample clinical data from the `{clindata}` package to run the Advers Generating input data is outside the scope of the assessment pipeline itself. However, the specifications for `dfInput` are designed to be flexible enough so that this data frame can be generated from multiple clinical data standards. For example, users can run the `Map_Raw()` or `Map_Adam()` functions, which will create `dfInput` from Raw+ data or CDISC-compliant ADaM data, respectively. The [`{gsm}` data pipeline](https://silver-potato-cfe8c2fb.pages.github.io/articles/DataPipeline.html) will be expanded upon in the future to incorporate data from various dashboards as well. -The data frame `dfInput` needs to have one record per subject, with the following columns: +The data frame `dfInput` for an Adverse Event will be created by running `AE_Map_Raw()` and will have one record per subject, with the following columns: - `SubjectID` = Subject Identifier - `SiteID` = Site Identifier From a244fe6e8a725b157e63d57bad326ee1b6bb270c Mon Sep 17 00:00:00 2001 From: Colleen McLaughlin <113617067+collleenmclaughlin@users.noreply.github.com> Date: Fri, 14 Oct 2022 11:15:47 -0400 Subject: [PATCH 13/21] Update vignettes/DataAnalysis.Rmd Co-authored-by: Jeremy Wildfire --- vignettes/DataAnalysis.Rmd | 2 +- 1 file changed, 1 insertion(+), 1 deletion(-) diff --git a/vignettes/DataAnalysis.Rmd b/vignettes/DataAnalysis.Rmd index 6d8365691..4f077372a 100644 --- a/vignettes/DataAnalysis.Rmd +++ b/vignettes/DataAnalysis.Rmd @@ -52,7 +52,7 @@ We will use sample clinical data from the `{clindata}` package to run the Advers ### 1. Create `dfInput` -Generating input data is outside the scope of the assessment pipeline itself. However, the specifications for `dfInput` are designed to be flexible enough so that this data frame can be generated from multiple clinical data standards. For example, users can run the `Map_Raw()` or `Map_Adam()` functions, which will create `dfInput` from Raw+ data or CDISC-compliant ADaM data, respectively. The [`{gsm}` data pipeline](https://silver-potato-cfe8c2fb.pages.github.io/articles/DataPipeline.html) will be expanded upon in the future to incorporate data from various dashboards as well. +Generating input data is outside the scope of the assessment pipeline itself. However, the specifications for `dfInput` are designed to be flexible enough so that this data frame can be generated from multiple clinical data standards. For example, users can run the `Map_Raw()` or `Map_Adam()` functions, which will create `dfInput` from Raw+ data or CDISC-compliant ADaM data, respectively. The data frame `dfInput` for an Adverse Event will be created by running `AE_Map_Raw()` and will have one record per subject, with the following columns: From dfc9fbd2ba6558e45cd1347ad08cc9ea7ccd418f Mon Sep 17 00:00:00 2001 From: Colleen McLaughlin <113617067+collleenmclaughlin@users.noreply.github.com> Date: Fri, 14 Oct 2022 11:15:54 -0400 Subject: [PATCH 14/21] Update vignettes/DataAnalysis.Rmd Co-authored-by: Jeremy Wildfire --- vignettes/DataAnalysis.Rmd | 2 +- 1 file changed, 1 insertion(+), 1 deletion(-) diff --git a/vignettes/DataAnalysis.Rmd b/vignettes/DataAnalysis.Rmd index 4f077372a..3ba1b11d9 100644 --- a/vignettes/DataAnalysis.Rmd +++ b/vignettes/DataAnalysis.Rmd @@ -46,7 +46,7 @@ For the purposes of this documentation, we will evaluate the input(s) and output ------------------------------------------------------------------------ -## A Technical Demo - Step-By-Step +## Case Study - Step-by-step Adverse Event KRI We will use sample clinical data from the `{clindata}` package to run the Adverse Events (AE) Assessment, i.e., `AE_Assess()`. From 7f74889110952c40b617b81e66e589c932c27158 Mon Sep 17 00:00:00 2001 From: Colleen McLaughlin Date: Fri, 14 Oct 2022 17:32:29 +0000 Subject: [PATCH 15/21] Updates based on comments --- vignettes/DataAnalysis.Rmd | 91 ++++++++++++++++++++++---------------- 1 file changed, 53 insertions(+), 38 deletions(-) diff --git a/vignettes/DataAnalysis.Rmd b/vignettes/DataAnalysis.Rmd index 3ba1b11d9..6ddf26030 100644 --- a/vignettes/DataAnalysis.Rmd +++ b/vignettes/DataAnalysis.Rmd @@ -36,25 +36,27 @@ dt <- function(data){ This vignette walks users through the mechanics of the `Assess()` functions within the `{gsm}` package. `{gsm}` leverages Key Risk Indicators (KRIs) and thresholds to conduct study-level and site-level Risk Based Monitoring for clinical trials. The `Assess()` functions provide data frames, visualization, and metadata to be used in reporting and error checking at clinical sites. The image below illustrates the supporting functions that feed into the workflow of the `Assess()` functions. -![](data-analysis.PNG){width=100%} +![](data-analysis.PNG){width = 100%} All of these functions will run automatically and sequentially when a user calls upon a given `Assess()` function. Each of these individual functions can also be run independently outside of an `Assess()` function. -For the purposes of this documentation, we will evaluate the input(s) and output(s) of each individual function to show the stepwise progression of how `Assess()` handles and processes data. +For the purposes of this documentation, we will evaluate the input(s) and output(s) of each individual function for a specific KRI to show the stepwise progression of how `Assess()` handles and processes data. ------------------------------------------------------------------------ -## Case Study - Step-by-step Adverse Event KRI +## Case Study - Step-by-Step Adverse Event KRI -We will use sample clinical data from the `{clindata}` package to run the Adverse Events (AE) Assessment, i.e., `AE_Assess()`. +We will use sample clinical data from the `{clindata}` package to run the Adverse Events (AE) Assessment, i.e., `AE_Assess()`, using the Poisson statistical model. + +Additional statistical methods and supporting functions are explored in [Appendix 1](#appendix-1). ### 1. Create `dfInput` -Generating input data is outside the scope of the assessment pipeline itself. However, the specifications for `dfInput` are designed to be flexible enough so that this data frame can be generated from multiple clinical data standards. For example, users can run the `Map_Raw()` or `Map_Adam()` functions, which will create `dfInput` from Raw+ data or CDISC-compliant ADaM data, respectively. +Generating input data is outside the scope of the assessment pipeline itself. However, the specifications for `dfInput` are designed to be flexible enough so that this data frame can be generated from multiple clinical data standards. For example, users can run the `Map_Raw()` function, which will create `dfInput` from Raw+ data. -The data frame `dfInput` for an Adverse Event will be created by running `AE_Map_Raw()` and will have one record per subject, with the following columns: +The data frame `dfInput` for an AE assessment will be created by running `AE_Map_Raw()` and will have one record per subject, with the following columns: - `SubjectID` = Subject Identifier - `SiteID` = Site Identifier @@ -81,10 +83,7 @@ dt(dfInput) ### 2. Create `dfTransformed` -The data frame `dfTransformed` is derived from `dfInput` using one of the following functions (depending on the assessment being run): - -- `Transform_Rate()`: Calculates cumulative rate of Event(s) of Interest per site. In our example, the default metric for AEs is the number of AEs reported over the course of treatment per site. -- `Transform_Count()`: Calculates cumulative numer of Event(s) of Interest per site. *This function is not used in `AE_Assess()` because the default metric for AEs is a rate.* +The data frame `dfTransformed` is derived from `dfInput` using a `Transform()` function. In our example, the analysis pipeline pulls in `Transform_Rate()` since the default metric for AEs is the number of AEs reported over the course of treatment per site, i.e., a rate. The resulting `dfTransformed` data frame will contain site-level transformed data, including KRI calculation. Using our example AE data, `dfTransformed` contains the following columns: @@ -109,13 +108,7 @@ dt(dfTransformed) ### 3. Create `dfAnalyzed` -The data frame `dfAnalyzed` is derived from `dfTransformed` using one of the following functions, which were built from a specific statistical model (depending on the assessment being run): - -- `Analyze_Fisher()`: Uses Fisher's Exact Test to determine if there are non-random associations between a site and a given KRI -- `Analyze_Identity()`: Used in the data pipeline between `Transform()` and `Flag()` functions to rename KRI and Score columns -- `Analyze_Poisson()`: Uses a Poisson model to describe the distribution of events in the overall site population, i.e., determine how many times an event is likely to occur at a site over a specified treatment period - -The resulting `dfAnalyzed` data frame will contain site-level analysis results data. The Poisson model is the default analysis function for AE data, so using our example AE data, `dfAnalyzed` contains the following columns: +The data frame `dfAnalyzed` is derived from `dfTransformed` using an `Analyze()` function, which incorporates a specific statistical model. The resulting `dfAnalyzed` data frame will contain site-level analysis results data. The Poisson model is the default statistical model for AE data, so the analysis pipeline automatically runs `Analyze_Poisson()`. Using our example AE data, `dfAnalyzed` contains the following columns: - `GroupID` = Group Identifier (default is Site ID) - `Numerator` = Cumulative Number of Event(s) of Interest (in this example, number of AEs reported across subjects); Carried from `dfTransformed` @@ -136,13 +129,7 @@ dt(dfAnalyzed) ### 4. Create `dfFlagged` -The data frame `dfFlagged` is derived from `dfAnalyzed` using one of the following functions (depending on the assessment and the specific statistical model that was run): - -- `Flag_Fisher()`: Default flagging function when `Analyze_Fisher()` is used for an assessment -- `Flag_Poisson()`: Default flagging function when `Analyze_Poisson()` is used for an assessment -- `Flag()`: Default flagging function when `Analyze_Identity()` is used for an assessment - -The resulting `dfFlagged` data frame will contain site-level analysis results data with flagging incorporated based on a pre-specified statistical threshold to highlight possible outliers. The default threshold for the AE Poisson model is (-7, -5, 5, 7) based on the available literature, so using our example AE data, `dfFlagged` contains the following columns: +The data frame `dfFlagged` is derived from `dfAnalyzed` using a `Flag()` function. The resulting `dfFlagged` data frame will contain site-level analysis results data with flagging incorporated based on a pre-specified statistical threshold to highlight possible outliers. The default flagging function for the AE Poisson model is `Flag_Poisson()` and the default threshold is (-7, -5, 5, 7) based on the available literature. Using our example AE data, `dfFlagged` contains the following columns: - `GroupID` = Group Identifier (default is Site ID) - `Numerator` = Cumulative Number of Event(s) of Interest (in this example, number of AEs reported across subjects); Carried from `dfAnalyzed` @@ -183,13 +170,7 @@ dt(dfSummary) ### 6. Data Visualization -Data visualizations are built into each `Assess()` function/KRI using the following functions: - -- `Visualize_Scatter`: Creates scatter plot of Total Exposure (in days, on log scale) vs Total Number of Event(s) of Interest (on linear scale). Each data point represents one site. Outliers are plotted in red with the site label attached. This plot is only created when statistical method is **not** defined as `identity`. -- `Visualize_Score`: Provides a standard visualization for Score or KRI -- `Visualize_Workflow`: Provides a flowchart with a high-level overview of the data pipeline for a given assessment - -For an AE assessment, a scatter plot is created using `dfTransformed` to define bounds and `dfFlagged` to plot the data. Using our example AE data, we see the following scatter plot: +Data visualizations are built into each `Assess()` function/KRI. For a Poisson AE assessment, a scatter plot of Total Exposure (in days, on log scale) vs Total Number of Event(s) of Interest (on linear scale) is created. Each data point represents one site with outliers displayed in red. The `Visualize_Scatter()` function takes inputs of `dfTransformed` to define bounds and `dfFlagged` to plot the data. Using our example AE data, we see the following scatter plot: ```{r} dfBounds <- Analyze_Poisson_PredictBounds(dfTransformed, vThreshold = c(-8, 8)) @@ -203,16 +184,50 @@ chart ------------------------------------------------------------------------ -# Recap +# Recap - Poisson Adverse Event KRI -- `dfInput` used as original input; Can be created using `Map_Raw()` or `Map_Adam()`, if needed -- `dfTransformed` created from `dfInput` using `Transform_Count()` or `Transform_Rate()` -- `dfAnalyzed` created from `dfTransformed` using `Analyze_Poisson()`, `Analyze_Fisher()`, or `Analyze_Identity()` -- `dfFlagged` created from `dfAnalyzed` using `Flag_Poisson()`, `Flag_Fisher()`, or `Flag()` +- `dfInput` used as original input using `Map_Raw()` +- `dfTransformed` created from `dfInput` using `Transform_Rate()` +- `dfAnalyzed` created from `dfTransformed` using `Analyze_Poisson()` +- `dfFlagged` created from `dfAnalyzed` using `Flag_Poisson()` - `dfSummary` created from `dfFlagged` using `Summarize()` -- Visualizations created from `dfTransformed` and `dfFlagged` +- Scatter plot created from `Visualize_Scatter()` using `dfTransformed` and `dfFlagged` + +------------------------------------------------------------------------ + +# Appendix 1 - Supporting Functions (#appendix-1) + +The following sections include various examples of supporting functions and statistical models that can be employed in the `Assess()` functions. Please note that this is **not** an exahustive list, but includes some of the most commonly called upon functions. + +### Mapping Functions + +- `Map_Raw()`: Creates input data using Raw+ data +- `Map_Adam()`: Creates input data using CDISC-compliant ADaM data + +### Transform Functions + +- `Transform_Rate()`: Calculates cumulative rate of Event(s) of Interest per site +- `Transform_Count()`: Calculates cumulative numer of Event(s) of Interest per site + +### Analyze Functions + +- `Analyze_Fisher()`: Uses Fisher's Exact Test to determine if there are non-random associations between a site and a given KRI +- `Analyze_Identity()`: Used in the data pipeline between `Transform()` and `Flag()` functions to rename KRI and Score columns +- `Analyze_Poisson()`: Uses a Poisson model to describe the distribution of events in the overall site population, i.e., determine how many times an event is likely to occur at a site over a specified treatment period + +### Flag Functions + +- `Flag_Fisher()`: Default flagging function when `Analyze_Fisher()` is used for an assessment +- `Flag_Poisson()`: Default flagging function when `Analyze_Poisson()` is used for an assessment +- `Flag()`: Default flagging function when `Analyze_Identity()` is used for an assessment + +### Visualization Functions + +- `Visualize_Scatter`: Creates scatter plot of Total Exposure (in days, on log scale) vs Total Number of Event(s) of Interest (on linear scale). Each data point represents one site. Outliers are plotted in red with the site label attached. This plot is only created when statistical method is **not** defined as `identity`. +- `Visualize_Score`: Provides a standard visualization for Score or KRI +- `Visualize_Workflow`: Provides a flowchart with a high-level overview of the data pipeline for a given assessment -What statistical models are available for each assessment? +### What Statistical Models Are Available For Each Assessment? - Adverse Events (AE) and Protocol Deviations (PD): **Poisson or Identity** - Subject Consent (Consent) and Inclusion/Exclusion (IE) Criteria: **Identity** From 7a11fb6ce071818329162ca225e939df8fd2209a Mon Sep 17 00:00:00 2001 From: Colleen McLaughlin Date: Fri, 14 Oct 2022 19:05:37 +0000 Subject: [PATCH 16/21] Finishing touches --- vignettes/DataAnalysis.Rmd | 16 ++++++++-------- 1 file changed, 8 insertions(+), 8 deletions(-) diff --git a/vignettes/DataAnalysis.Rmd b/vignettes/DataAnalysis.Rmd index 6ddf26030..3c7be1ed5 100644 --- a/vignettes/DataAnalysis.Rmd +++ b/vignettes/DataAnalysis.Rmd @@ -24,7 +24,7 @@ dt <- function(data){ DT::datatable( extensions = 'FixedColumns', options = list( - scrollX = TRUE, + scrollX = FALSE, fixedColumns = TRUE ), rownames = FALSE @@ -36,7 +36,7 @@ dt <- function(data){ This vignette walks users through the mechanics of the `Assess()` functions within the `{gsm}` package. `{gsm}` leverages Key Risk Indicators (KRIs) and thresholds to conduct study-level and site-level Risk Based Monitoring for clinical trials. The `Assess()` functions provide data frames, visualization, and metadata to be used in reporting and error checking at clinical sites. The image below illustrates the supporting functions that feed into the workflow of the `Assess()` functions. -![](data-analysis.PNG){width = 100%} +![](data-analysis.PNG){width=100%} All of these functions will run automatically and sequentially when a user calls upon a given `Assess()` function. @@ -170,7 +170,7 @@ dt(dfSummary) ### 6. Data Visualization -Data visualizations are built into each `Assess()` function/KRI. For a Poisson AE assessment, a scatter plot of Total Exposure (in days, on log scale) vs Total Number of Event(s) of Interest (on linear scale) is created. Each data point represents one site with outliers displayed in red. The `Visualize_Scatter()` function takes inputs of `dfTransformed` to define bounds and `dfFlagged` to plot the data. Using our example AE data, we see the following scatter plot: +Data visualizations are built into each `Assess()` function/KRI. For a Poisson AE assessment, a scatter plot of Total Exposure (in days, on log scale) vs Total Number of Event(s) of Interest (on linear scale) is created. Each data point represents one site with outliers displayed in yellow or red, depending on the "extremeness" of the KRI value. The `Visualize_Scatter()` function takes inputs of `dfTransformed` to define bounds and `dfFlagged` to plot the data. Using our example AE data, we see the following scatter plot: ```{r} dfBounds <- Analyze_Poisson_PredictBounds(dfTransformed, vThreshold = c(-8, 8)) @@ -178,7 +178,7 @@ dfBounds <- Analyze_Poisson_PredictBounds(dfTransformed, vThreshold = c(-8, 8)) chart <- Visualize_Scatter(dfFlagged, dfBounds) ``` -```{r, echo = FALSE} +```{r, echo = FALSE, fig.width=7, fig.height=5} chart ``` @@ -195,9 +195,9 @@ chart ------------------------------------------------------------------------ -# Appendix 1 - Supporting Functions (#appendix-1) +# Appendix 1 - Supporting Functions {#appendix-1} -The following sections include various examples of supporting functions and statistical models that can be employed in the `Assess()` functions. Please note that this is **not** an exahustive list, but includes some of the most commonly called upon functions. +The following sections include various examples of supporting functions and statistical models that can be employed in the `Assess()` functions. Please note that this is **not** an exhaustive list, but includes some of the most commonly called upon functions. ### Mapping Functions @@ -207,7 +207,7 @@ The following sections include various examples of supporting functions and stat ### Transform Functions - `Transform_Rate()`: Calculates cumulative rate of Event(s) of Interest per site -- `Transform_Count()`: Calculates cumulative numer of Event(s) of Interest per site +- `Transform_Count()`: Calculates cumulative number of Event(s) of Interest per site ### Analyze Functions @@ -233,4 +233,4 @@ The following sections include various examples of supporting functions and stat - Subject Consent (Consent) and Inclusion/Exclusion (IE) Criteria: **Identity** - Subject Disposition (Disp) and Laboratory (LB) Results: **Fisher or Identity** -![](data-analysis-combined.PNG) +![](data-analysis-combined.PNG){width=100%} From 8a57e5ed424831f2c870671a166e3876225e212b Mon Sep 17 00:00:00 2001 From: Colleen McLaughlin Date: Fri, 14 Oct 2022 19:48:26 +0000 Subject: [PATCH 17/21] Troubleshooting CI --- DESCRIPTION | 1 + vignettes/DataAnalysis.Rmd | 2 -- 2 files changed, 1 insertion(+), 2 deletions(-) diff --git a/DESCRIPTION b/DESCRIPTION index a87a3c715..2efc34a36 100644 --- a/DESCRIPTION +++ b/DESCRIPTION @@ -40,6 +40,7 @@ Suggests: clindata, covr, devtools, + DT, here, kableExtra, pander, diff --git a/vignettes/DataAnalysis.Rmd b/vignettes/DataAnalysis.Rmd index 3c7be1ed5..57290bdb2 100644 --- a/vignettes/DataAnalysis.Rmd +++ b/vignettes/DataAnalysis.Rmd @@ -14,9 +14,7 @@ knitr::opts_chunk$set( ) library(gsm) -library(tidyverse) library(DT) -library(rmdformats) library(gt) dt <- function(data){ From 73d571921d80ad15de4fb86ba696b23175705d6d Mon Sep 17 00:00:00 2001 From: Colleen McLaughlin <113617067+collleenmclaughlin@users.noreply.github.com> Date: Mon, 17 Oct 2022 12:32:51 -0400 Subject: [PATCH 18/21] Delete data-analysis-combined.PNG --- vignettes/data-analysis-combined.PNG | Bin 36707 -> 0 bytes 1 file changed, 0 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