Table 2.
Personalization of Per-DS Attributes Considered in PREEMPT Study10 11 12
| Category | Attribute | Options Considered/Offered to PREEMPT Participants | |
|---|---|---|---|
| Trial design | Pain management treatments to be compared | Same two treatments compared for all participants | * Each participant selects two treatment sets from list of suitable treatment options (e.g., NSAID, opioid, NSAID + opioid, complementary/alternative treatments) |
| Duration of treatment period | Fixed for all participants | * Two options: one vs. two weeks | |
| Stopping rule | * Fixed | Sequential or adaptive | |
| Total number of treatment periods under fixed stopping rule | Fixed for all participants | * Three options: four, six, or eight treatment periods | |
| Washout between treatment periods | Yes, set time with neither treatment between treatment periods | * No, treatment switched immediately without gap between periods, with option for subsequent “analytic washout” such as discarding outcomes at beginning of each treatment period. | |
| Blinding of treatment assignment | Yes | * No | |
| Outcomes | Outcomes to be measured | Fixed for all participants | * Core outcomes fixed, option for each participant to choose additional outcomes (like neuropathic pain) |
| Primary outcome for each personalized trial | Fixed for all participants | * Based on patient preference (may select an outcome different from primary outcome for overall study) | |
| Frequency of outcome assessments | * Daily | Multiple times per day, or ecological momentary assessment 89 | |
| Trial implement-tation | Use of reminders to take treatments and enter patient-reported outcomes | * Yes | No |
| Frequency and timing of reminders if used | Fixed | * Specify according to patient preference | |
| Ability for patient to adjust or turn off reminders | * Yes | No | |
| Data analysis | Ability for patient to access interim data and interim analysis results | * Yes | No |
| Analysis plan (both interim and final) | * Predetermined | Specified according to patient preference | |
| Presentation of results | Display format | * Graphical | Tabular or hybrid |
| Details provided | * Simple point estimates | * Comprehensive, including point estimates and margin of error | |
*
Attribute options marked with an asterisk were implemented in the PREEMPT Study. Other options were considered but not implemented.