NEWS.md

In mds: Medical Devices Surveillance

mds 0.3.3

UNDER DEVELOPMENT - FUTURE RELEASE

mds 0.3.2

Implemented Updates

Bugfix - Replace ifelse() calls that return Dates with calls to ifelse_cp()

mds 0.3.1

Implemented Updates

General - Explicit declarations of stringsAsFactors=T in all data.frame() calls for cross-version compatibility

mds 0.3.0

Implemented Updates

General - Overall improvement of documentation & detailed descriptions of functions - Input parameter covariates specified in deviceevent() must be either factor or numeric, no longer character. - Input parameter match_levels specified in time_series() must be factor, no longer character. - Add to output of define_analyses() a function for adding dates in the units specified by date_level and date_level_n - Deprecated use_hierarchy parameter in time_series() - Explicit carry-forward of define_analysis id

Covariate Handling - Explicit handling of covariate level analysis in deviceevent(), define_analyses(), and time_series() - Added analysis data frame to time_series() output when covariate analysis is requested - Covariates can now be EITHER factor OR numeric types when defined in deviceevent(). Previously only characters (inferred as factors) werea allowed. - Covariate analysis definitions include as a whole (marginal effect) or as a subset by a factor covariate level - Covariate analysis is exempt if there is zero variation in the data of the covariate - Restructured exposure() to handle factors only in match_levels.

Implantable Devices / Time In-Vivo Handling - Explicit handling of time in-vivo in deviceevent(), define_analyses(), and time_series() - Added analysis data frame to time_series() output when time in-vivo analysis is requested - CHANGED PARAMETER deviceevent(implant_days) to deviceevent(time_invivo) and make all downstream changes.

To-Do List - Feature allowing total events (concept of reporting fraction) as an exposure data frame - Facility for handling multiple events on the same actual occurrence (such as stroke and bleeding during the same operation) - Explicit implementation of the Unique Device Identifier (UDI) - Implementation of IMDRF coding for product malfunctions, patient adverse events, and analysis findings

mds 0.2.1

Implemented Updates

• More descriptive define_analyses() and time_series() outputs, including explicit references to device, event, and covariate levels.
• Alongside more explicit references, corresponding updates to nLabels attribute of time_series()
• Outputs of define_analyses() and time_series() are clearer about the device and event one-up hierarchy levels
• Updated plot() method to support updates to define_analyses() and time_series()

mds 0.2.0

Implemented Updates

• Allow for list variable type in deviceevents() descriptors argument
• Wrote time_series() examples in documentation & provided sample time series dataset called mds_ts
• Better cross-referenced and linked documentation

Bugfixes

• exposure() total_events parameter now accepts integer class
• deviceevent(): Drop records with missing device_levels at all hierarchy levels
• deviceevent(): Drop records with missing event_levels
• deviceevent(): Drop records with missing covariate levels
• exposure(): Drop records with missing device_levels at all hierarchy levels
• exposure(): Drop records with missing event_levels
• exposure(): Drop records with missing match levels

mds 0.1.0

• Initial Release. Yay!

mds documentation built on July 1, 2020, 10:38 p.m.