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Table 1 Overview of available specification parameters

From: Simulating complex patient populations with hierarchical learning effects to support methods development for post-market surveillance

Parameter

Description of feature

Patient generation

 # of institutions

Total number of institutions to represent in the dataset

 Provider distribution

Distribution of number of providers within each institution

 Patient feature set

Distributions and correlations of patient features specified by EHR dataset or user definitions

 Provider patient volumes

Distribution of the annual number of patients treated by a provider

 Provider entry

Whether provider entry into case series should be staggered

Treatment assignment

 Treatment prevalence

Proportion of patients receiving each treatment

 Treatment associations

Associations specifying how patient features influence treatment assignment

Patient and treatment associated risk

 Treatment risk

Difference in the risk of an adverse outcome associated with a novel treatment compared to the reference treatment

 Outcome risk factors

Associations specifying how patient features influence the risk of an adverse outcome

 Population adverse event rate

Proportion of the population experiencing an adverse outcome due to patient risk factor and treatment risk

Provider learning-associated risk

 Provider learning – form

Functional form of learning curve (impacts steadiness or steepness of learning)

 Provider learning – speed

Number of patients receiving the novel treatment before providers reach 95% of asymptotic performance

 Provider learning—magnitude

Magnitude of learning-associated risk when a provider first starts using the novel treatment

Institutional learning-associated risk

 Institutional learning – form

Functional form of learning curve (impacts steadiness or steepness of learning)

 Institutional learning – speed

Number of patients receiving the novel treatment before institutions reach 95% of asymptotic performance

 Institutional learning – magnitude

Magnitude of learning-associated risk when an institution first starts using the novel treatment

Data finalization

 Missingness

Proportion of missing values

 Noise

Additional random noise in outcome generation

 Omitted variables

Patient features to be excluded from final data