A Modification History

Table A.1: History of Modifications
Version Date Modification Input File Changes
4.0.0 9/30/2024
  • Added summary table for outcomes in a descriptive pregnancy (Type 4) analysis
  • Added the ability to conduct a time to event analysis in pregnancy
  • Removed MILGRP as a valid value in the BASELINEFILE and LABELFILE and replaced with ability to specify individual exposure or reference cohorts
  • Minor package updates
,Type 4 Level 1 Table File Lookup Table
  • Added T7 (t4cida) table
Table Columns File
  • Added columns for T7
3.2.0 7/30/2024
  • Added ability to conduct signal identification with a tree-based scan Poisson statistic using unweighted/weighted PS stratification and inverse probability of treatment weighting
  • Added ability to produce a report for Type 3 signal identification queries and removed the ability to execute tree aggregation stand alone without creating a report
  • Produced TreeScan™ compatible datasets in csv format
  • Minor package updates
,Create Report File
  • Added T3 and removed TREE2, TREE3, and TREE4 as valid values for REPORTTYPE
3.1.1 4/11/2024
  • Minor package updates
None
3.1.0 3/7/2024
  • Implemented functionality for compatibility with Sentinel Views 2.0.0
  • Added ability to report on medical product use in the post-partum period by gestational week
  • Minor package updates
None
3.0.1 1/18/2024
  • Minor package updates
None
3.0.0 12/13/2023
  • Added ability to report on medical product use during pregnancy when analyzing cohorts that include non-live pregnancy outcomes
  • Added ability to report on covariates defined in both mother and linked infant records
  • Added ability to report medical product use in the post-partum period
  • Minor package updates
Table Columns File
  • Added new columns to T1-T4
2.2.0 9/8/2023
  • Updated reporting tool to align with QRP’s new pregnancy identification algorithm
  • Added risk scores to characteristics table
  • Changed characteristics table footnote describing covariates not included in propensity score model to describe covariates included in propensity score model
  • Minor package updates
BaselineFile
  • Removed COVNOTINPS
  • Added COVINPS
2.1.0 4/14/2023
  • Added ability to conduct a propensity score (PS) analysis adjusting for inverse probability of treatment weights, PS stratification weights, and variable ratio PS matching when conduing PS analyses in pregnant cohorts
  • Sunset the ability to produce an effect estimate using individual level data
  • Sunset the ability to adjust odds ratios for selection bias when conducting PS analyses in pregnant cohorts
  • Added ability to produce datasets for inferential analyses for Sentinel Views
  • Minor package updates
L2 Comparison File
  • Removed CLASSVARS and NOCLASSVARS
Create Report File
  • Added JIRAKEY and USERID and STUDYTITLE
Removed Selection Probabilities File
2.0.0 10/28/2022
  • Added ability to define laboratory covariates in the Characteristics Table in Propensity Score reports
  • Added the ability to use input files that are .csv instead of .sas7bdat (with limitations)
  • Added the ability to produce datasets for Sentinel Views
  • Minor package updates
Create Report File
  • Added OUTPUTVIEWSDATA
1.4.0 8/17/2022
  • Added LABCHARACTERISTICS parameter to allow display of lab covariates in the Characteristics Table
  • Modified comma delimited parameters to be space delimited
  • Added ability to include DEMOGRAPHIC.RACE = M in reports, introduced in SCDM 8.1.0
  • Added site stratified Kaplan-Meier curves, 95% confidence intervals, and Kaplan-Meier curves for IPTW and PS Stratum Weighted analyses in Propensity Score reports
  • Added cumulative incidence curves for Type 6 reports
  • Added automated log checker
  • Minor package updates
Baseline File
  • Renamed BASELINEROWITALICS to COVNOTINPS
  • Added new parameter LABCHARACTERISTICS
Multiple Files
  • Removed quotes from all multi-select parameters; removed commas from all multi-value parameters
1.3.0 4/4/2022
  • Added Type 4 Medical Product of Interest by trimester and by gestational week summary tables
  • Added L2 baseline tables, figures, and appendices for subgroup analyses
  • Added ability to collapse race categories for L1 tables and figures and implemented missing value indicator when race is not available at a data partner
  • Added ability to report year, year-month, and year-quarter metrics for Type 5 summary tables
  • Changed the name of REDACTCOLUMNS to CUSTOMIZECOLUMNS and added new parameter options
  • Updated column labels and available columns in the TABLECOLUMNSFILE for Types 1 and 2 summary tables
  • Added default footnotes in tables for all Type 4 reports
  • Minor package updates
Create Report File
  • Renamed REDACTCOLUMNS to CUSTOMIZECOLUMNS
  • Added COLLAPSEVARS
Selection Probabilities File
  • Added SUBGROUP and SUBGROUPCAT
  • Removed COVARNUM
1.2.4 1/21/2022
  • Minor package updates
None
1.2.3 11/22/2021
  • Minor package updates
None
1.2.2 11/8/2021
  • Minor package updates
None
1.2.1 11/3/2021
  • Minor package updates
None
1.2.0 11/2/2021
  • Integrated Type 6 censor tables
  • Added the ability to report quarter-year stratifications for Type 1 and Type 2 tables
  • Minor package updates
None
1.1.0 10/21/2021
  • Integrated Type 1 tables
  • Integrated standard Type 2 and concomitant use tables
  • Integrated Type 5 figures
  • Minor package updates
None
1.0.0 9/30/2021 Original published version