Table 3

Saturation grid of elements identified through published literature and engaged stakeholders (pages 1–2 of 3)

Previously published literatureRegistry representativeHealth system representativeClinicianPatient and Patient caregiverDevice manufacturerDevice application reviewersData coordinatorData analystData informaticianPayer/HTATotal
Identification of medical devices for the development of OPCXXXXXXXXXXX11
Device selection is a careful and conscientious processXXXXX6
Sufficiently mature device with sufficient collected real-world dataXXXXX5
Sufficient level of understanding associated with the technologyXXX3
Natural history of the indication understoodXXX3
Priority given to medical devices with specific characteristicsXXX3
Previously published literature ought to be reviewed for existing OPCXXXX4
Engagement of key stakeholdersXXXXXXXXXXX11
OPC generation is a collaborative effortXXXXXXXX8
Stakeholders involved
Regulatory and notified bodiesXXXXXXXXXX10
Industry/device manufacturersXXXXXXXXX9
Data ownersXX2
Payers and HTA bodiesXXXXXX6
Hospital health systemsXX2
Professional organizationsXXX3
Epidemiologists and analystsXXX3
Data informaticianX1
Multistakeholder collaborative a priori decision makingXXXXXXX7
Determination of minimally clinically important differencesXXXX4
Selection of an appropriate data sourceXXXXXXXXXX10
Differing data sources for OPG (Objective Performance Goals) versus OPC (Objective Performance Crtieria) creationXXXX4
Prioritize data sources with standardized data elements and librariesXXXXX5
Prioritize data sources that capture clinically meaningful relevant outcomes to patientsXXXXXXXX8
Data quality assessed using the IMDRF’s (International Medical Device Regulators Forum) eight characteristics of a registryXX2
Consider national registries, international registries, claims and linked data sourcesXXXX4
Performance of appropriate statistical analysesXXXXXXXXXXX11
Identification of the study Population
Clearly define the study cohort with appropriate inclusion and exclusion criteriaXXXX4
Consult stakeholders, expert opinion and literature to determine appropriate inclusion/exclusion criteriaXXX3
Required sample size needs to be statistically justified and hypothesis drivenX1
Assess and include effectiveness and safety endpointsXXXXXXXXX9
Discuss the determination of appropriate endpoints and their definitionsXXXXXXXXX9
Include short-term and long-term outcomesXXXXXXX7
Select endpoints relevant to the patientXXXXXXXX8
Engage patients to capture any endpoints due to unintended consequences of the deviceXXXXX5
When available, include functional outcomes such as patient-reported outcomesXXXXX5
When possible, assess soft endpointsXX2
When possible, assess quality endpointsXX2
Assess endpoints at relevant time points to provide suitable comparisons in single-armed trialsXXX3
Assess long-term endpoints at the most prolonged time possibleXXX3
Identification and selection of covariates
Report available patient-level, provider-level, facility-level and device-level characteristicsXXXX4
Capture common co-occurring illnessesXXXX4
Differentiate between covariates and confoundersXXX3
Remove irrelevant independent variables from the modelX1
Missing data
Assess the level of missingnessXX2
Attempt to determine the type of missingnessXX2
Discuss how missing data were handledXX2
Statistical analyses
Report and justify the model identification methodXXX3
  • HTA, health technology assessment; OPC, objective performance criteria.