Table 4

Challenges to objective performance criteria (OPC) generation identified by stakeholders

Biggest challengeRegistry representativeHealth system representativeClinicianPatient and Patient caregiverDevice manufacturerDevice application reviewersData coordinatorData analystData informaticianPayer/HTATotal (n=36)*Percentage
Stakeholder consensus1121112925
Meaningful, accessible, high-quality data source22311211131747
Identifying and measuring meaningful outcomes and covariates211411
Identifying medical devices that would benefit from OPC11138
Resources: funding, data sources, patient-centerd stakeholders1126
Disseminating the results correctly113
  • *Some stakeholders cited more than one challenge; thus, the total number of cited challenges is greater than the number of stakeholders engaged.

  • HTA, health technology assessment; OPC, objective performance criteria .