Table 1.
Input values and data sources used in base case models and sensitivity analyses.
| Description | Base case | Low | High | Distribution | Data source |
|---|---|---|---|---|---|
| Costs and other resources | |||||
| Registry-related costs/resources | |||||
| Programmer salary | $74,831 | $37,746 | $150,986 | Gamma Mean: 74,831 SD: 8000 | Glassdoor (USA) |
| Programmer time to write initial query | 4.2 hours* | 2.75 hours | 11 hours | Normal Mean: 5.5 SD: 0.5 | Informed by interviews with programmers |
| Programmer time to implement query per centre | 2 hours* | 0.67 hours | 5 hours | Normal Mean: 2.5 SD: 1.25 | Informed by interviews with programmers |
| Programmer support time per centre | 2 hours | 0.5 hours | 4 hours | Normal Mean: 2.0 SD: 0.5 | Informed by interviews with programmers |
| Data manager salary | $69,638 | $36,292 | $145,168 | Gamma Mean: 69,638 SD: 9000 | Glassdoor (USA) |
| Statistician salary | $80,203 | $40,101 | $160,406 | Gamma Mean: 80,203 SD: 10,500 | Glassdoor (USA) |
| Research coordinator time to upload the query | 0.33 hours | 0.25 hours | 0.42 hours | Normal Mean: 0.33 hour SD: 0.08 hour | Informed by interviews with research coordinators |
| Number of software platforms per registry accessed | 1 | 1 | 100 | Uniform | Informed by interviews with investigators |
| Data coordinating centre analyst (statistician) time to write code to clean and link data registry case | 30 hours* | 10 hours | 80 hours | Normal Mean: 40 SD: 5 | Informed by interviews with trial statisticians |
| Individual centre data manager time to run query | 1.0 hour | 0.2 hour | 3.0 hour | Normal Mean: 1.0 SD: 0.25 | Informed by interviews with data managers |
| Number of centres involved in the study | 10 | 1 | 200 | Uniform | Informed by interviews with investigators |
| Data manager time to run the query | 0.76 hours* | 0.2 hours | 3.0 hours | Normal Mean: 1.0 SD: 0.25 | Informed by interviews with data managers |
| Cost of accessing data registry | $0 | $0 | $500,000 | Uniform | Informed by interviews with investigators |
| Standard abstraction-related costs/resources | |||||
| Clinical research coordinator salary | $57,596 | $29,407 | $117,628 | Gamma Mean: 57,596 SD: 9000 | Glassdoor (USA) |
| Statistician salary | $80,203 | $40,101 | $160,406 | Gamma Mean: 80,203 SD: 10,500 | Glassdoor (USA) |
| Data manager salary | $69,638 | $36,292 | $145,168 | Gamma Mean: 69,638 SD: 9000 | Glassdoor (USA) |
| Statistician time to clean data in standard case | 30 hours | 15 hours | 60 hours | Normal Mean: 30 SD: 5 | Informed by interviews with trial statisticians |
| Data manager time to clean data in standard case | 10 hours | 5 hours | 20 hours | Normal Mean: 10 SD: 1.5 | Informed by interviews with trial statisticians |
| Research coordinator time to manually enter data (per patient per variable) | 1.5 minutes | 10 seconds | 15 minutes | Beta Mean: 0.025 hours SD: 0.0125 hours | Informed by interviews with research coordinators |
| Number of patients involved in the study | 500 | 100 | 10,000 | Beta Mean: 500 SD: 250 | Informed by interviews with investigators |
| Number of discrete variables able to be abstracted from the registry | 200 | 50 | 1000 | Beta Mean: 200 SD: 100 | Informed by interviews with investigators |
| Fringe rate | 0.5 | 0.2 | 0.7 | Normal Mean: 0.5 SD: 0.1 | Department of Health and Human Services |
| Indirect cost rate | 0.7 | 0.5 | 0.9 | Normal Mean: 0.7 SD: 0.1 | Department of Health and Human Services |
| Probabilities | |||||
| Registry-related probabilities | |||||
| Percentage of variables able to be abstracted from the registry | 0.90 | 0.01 | 1.00 | Beta Mean: 0.90 SD: 0.05 | Informed by interviews with investigators |
| Probability that the centre will need additional query support/query rewrite | 0.75 | 0.25 | 1.00 | Beta Mean: 0.75 SD: 0.05 | Informed by interviews with programmers |
| Probability that the query data out of range (i.e. does need to be entered again manually) | 0.02 | 0.001 | 0.05 | Beta Mean: 0.02 SD: 0.005 | Informed by interviews with trial statisticians |
| Standard trial-related probabilities | |||||
| Percentage of erroneously manually entered variables | 0.02 | 0.001 | 0.05 | Beta Mean: 0.02 SD: 0.005 | Informed by interviews with trial statisticians |
*
Indicates that base case values include an “experience” or “efficiency” factor. All registry time-related variables were scaled using an experience function to account for the fact that, in the current era, staff may not be familiar with registry-based trial techniques and that there is a learning curve associated with implementation of these methods. The experience factor was defined by 1/(1.5^experience level), with an assumed a hyper-exponential distribution, with lambda = 1.5 and p = 0.4. Experience level grossly represents the number of times study personnel have previously implemented a registry-based trial. It was assumed that personnel involved in standard clinical trials are well versed in the nature of the work, as this has been the long-term trial strategy. SD = standard deviation.