Skip to content

Commit 9dcc21d

Browse files
committed
added fcn docs and revised README structure
1 parent 855bb3c commit 9dcc21d

File tree

3 files changed

+20
-94
lines changed

3 files changed

+20
-94
lines changed

R/functions.R

+2-2
Original file line numberDiff line numberDiff line change
@@ -1,6 +1,6 @@
11
#' Download the Pediatric Drug Safety database
22
#'
3-
#' Download the database published in Giangreco et al. 2022. Warning, the size of the uncompressed 'sqlite' file is close to 0.9GB or 900 MB. Use with caution
3+
#' Download the database published in Giangreco et al. 2022. This function will prompt to download the database, so the cache directory will be identified and the database will be downloaded to it only after consent. Warning, the size of the uncompressed 'sqlite' file is close to 0.9GB or 900 MB. Use with caution.
44
#'
55
#' @param method The method to download the sqlite database. See \code{download.file}
66
#' @param quiet Whether to download quietly. See \code{download.file}
@@ -116,7 +116,7 @@ disconnect_sqlite_db <- function(con){
116116

117117
#' Return database cache
118118
#'
119-
#' This function identifies and returns the cache location for the database on your machine
119+
#' This function returns the URL, sqlite database file, and cache names to be used for downloading the database to your machine.
120120
#'
121121
#' @importFrom tools R_user_dir
122122
#'

README.Rmd

+6-4
Original file line numberDiff line numberDiff line change
@@ -15,23 +15,27 @@ output: github_document
1515
knitr::opts_chunk$set(echo = TRUE)
1616
```
1717

18+
This R data package contains observation, summary, and model-level data from pediatric drug safety research developed by Nicholas Giangreco for his PhD dissertation in the Tatonetti lab at Columbia University.
19+
1820
# Installation
1921

22+
**The database is downloaded after consent is given when using the package. Installing the package will not download the database, but it will make it easier to download and connect to the database from your R session.**
23+
2024
```{r,eval=FALSE}
2125
install.packages('kidsides')
2226
remotes::install_github("ngiangre/kidsides")
2327
```
2428

2529
# Summary
2630

27-
This R data package contains observation, summary, and model-level data from pediatric drug safety research developed by Nicholas Giangreco for his PhD dissertation in the Tatonetti lab at Columbia University.
28-
2931
The database is comprised of 17 tables including a table with descriptions of the fields in each table. The main table, `ade_nichd`, contains quantitative data from nearly 500,000 pediatric drug safety signals across 7 child development stages spanning from birth through late adolescence (21 years of age).
3032

3133
The database was created using the methods and analyses in the references.
3234

3335
This data resource can be used under the [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/) license agreement.
3436

37+
**See the `Overview` vignette for more details on the data and the online portal**
38+
3539
# Usage
3640

3741
```{r}
@@ -61,8 +65,6 @@ kidsides::disconnect_sqlite_db(con)
6165
6266
```
6367

64-
** See the `Overview` vignette for more details on the data and the online portal**
65-
6668
# References
6769

6870

README.md

+12-88
Original file line numberDiff line numberDiff line change
@@ -11,19 +11,24 @@ coverage](https://codecov.io/gh/ngiangre/kidsides/branch/main/graph/badge.svg)](
1111
status](https://www.r-pkg.org/badges/version/kidsides)](https://CRAN.R-project.org/package=kidsides)
1212
<!-- badges: end -->
1313

14+
This R data package contains observation, summary, and model-level data
15+
from pediatric drug safety research developed by Nicholas Giangreco for
16+
his PhD dissertation in the Tatonetti lab at Columbia University.
17+
1418
# Installation
1519

20+
**The database is downloaded after consent is given when using the
21+
package. Installing the package will not download the database, but it
22+
will make it easier to download and connect to the database from your R
23+
session.**
24+
1625
``` r
1726
install.packages('kidsides')
1827
remotes::install_github("ngiangre/kidsides")
1928
```
2029

2130
# Summary
2231

23-
This R data package contains observation, summary, and model-level data
24-
from pediatric drug safety research developed by Nicholas Giangreco for
25-
his PhD dissertation in the Tatonetti lab at Columbia University.
26-
2732
The database is comprised of 17 tables including a table with
2833
descriptions of the fields in each table. The main table, `ade_nichd`,
2934
contains quantitative data from nearly 500,000 pediatric drug safety
@@ -36,6 +41,9 @@ references.
3641
This data resource can be used under the [CC BY
3742
4.0](https://creativecommons.org/licenses/by/4.0/) license agreement.
3843

44+
**See the `Overview` vignette for more details on the data and the
45+
online portal**
46+
3947
# Usage
4048

4149
``` r
@@ -176,90 +184,6 @@ dplyr::tbl(con,"ade_raw") %>%
176184
kidsides::disconnect_sqlite_db(con)
177185
```
178186

179-
# Background
180-
181-
Adverse drug reactions are a leading cause of morbidity and mortality
182-
that costs billions of dollars for the healthcare system. In children,
183-
there is increased risk for adverse drug reactions with potentially
184-
lasting adverse effects into adulthood. The current pediatric drug
185-
safety landscape, including clinical trials, is limited as it rarely
186-
includes children and relies on extrapolation from adults. Children are
187-
not small adults but go through an evolutionarily conserved and
188-
physiologically dynamic process of growth and maturation. We hypothesize
189-
that adverse drug reactions manifest from the interaction between drug
190-
exposure and dynamic biological processes during child growth and
191-
development.
192-
193-
We hypothesize that by developing statistical methodologies with prior
194-
knowledge of dynamic, shared information during development, we can
195-
improve the detection of adverse drug events in children. This data
196-
package downloads the SQLite database created by applying
197-
covariate-adjusted disproportionality generalized additive models
198-
(dGAMs) in a systematic way to develop a resource of nearly half a
199-
million adverse drug event (ADE) risk estimates across child development
200-
stages.
201-
202-
# Pediatric Drug Safety (PDS) data
203-
204-
## Observation-level data
205-
206-
The observation-level data, case reports for drug(s) potentially linked
207-
to adverse event(s), was collected by the Food and Drug Administration
208-
Adverse Event System (FAERS) in the US. This data is publicly available
209-
on the openFDA platform [here](https://open.fda.gov/data/downloads/) as
210-
downloadable [json files](https://api.fda.gov/download.json). However,
211-
utilizing this data as-is is non-trivial, where the drug event report
212-
data is published in chunks as a nested json structure each quarter per
213-
year since the 1990s. With an API key with extended permissions, I
214-
developed custom python notebooks and scripts available in the
215-
‘openFDA_drug_event-parsing’ github repository (DOI:
216-
<https://doi.org/10.5281/zenodo.4464544>) to extract and format all drug
217-
event reports prior to the third quarter of 2019. This observation-level
218-
data used, called Pediatric FAERS, for downstream analyses is stored in
219-
the table `ade_raw`.
220-
221-
## Summary-level data
222-
223-
The drugs and adverse events reported were coded into standard,
224-
hierarchical vocabularies. Adverse events were standardized by the
225-
Medical Dictionary of Regulatory Activities (MedDRA) vocabulary (details
226-
of the hierarcy founds
227-
[here](https://www.meddra.org/how-to-use/basics/hierarchy)). Drugs were
228-
standardized by the Anatomical Therapeutic Class (ATC) vocabulary
229-
(details found
230-
[here](https://www.who.int/tools/atc-ddd-toolkit/atc-classification)).
231-
The reporting of adverse events and drugs can be dependent on the
232-
disease context of a report’s subject. This was represented by
233-
summarizing the number of drugs of a therapeutic class for each report.
234-
235-
## Model-level data
236-
237-
We invented the disproportionality generalized additive model (dGAM)
238-
method for detecting adverse drug events from these spontaneous reports.
239-
We applied the logistic generalized additive model to all unique
240-
drug-event pairs in Pediatric FAERS. The drug-event GAM was used to
241-
quantify adverse event risk due to drug exposure versus no exposure
242-
across child development stages. Please see the references for the full
243-
specification and details on the GAM.
244-
245-
# PDSportal: accessible data access
246-
247-
We provide the [PDSportal](https://pdsportal.shinyapps.io/pdsportal/) as
248-
an accessible web application as well as a plaatform to download our
249-
database for the community to explore from identifying safety endpoints
250-
in clinical trials to evaluating known and novel developmental
251-
pharmacology.
252-
253-
# KidSIDES
254-
255-
The `kidsides` R package downloads a sqlite database to your local
256-
machine and connects to the database using the `DBI` R package. This is
257-
a novel data resource of half a million pediatric drug safety signals
258-
across growth and development stages. Please see the references for
259-
details on data fields and the [code
260-
repository](https://github.com/ngiangre/pediatric_ade_database_study)
261-
for the [paper](https://www.ssrn.com/abstract=3898786).
262-
263187
# References
264188

265189
Giangreco, Nicholas. Mind the developmental gap: Identifying adverse

0 commit comments

Comments
 (0)