Table 3.
Study data items by category.
| Data categories | Data items |
|---|---|
| Study design | Research objective |
| Study groups | |
| Funding source | |
| Geographic location | |
| Setting type | |
| Setting description | |
| Study design | |
| Primary outcomes | |
| Measurement intervals | |
| Patient characteristics | Sampling strategy |
| Unit of randomization | |
| Process of randomization | |
| Inclusion/exclusion criteria | |
| Number eligible | |
| Number randomized | |
| Number completers | |
| Number analyzed | |
| Mean age (or age range) | |
| Number female (%) | |
| Number race (%) | |
| Number ethnicity (%) | |
| Median income (%) | |
| Number insured (%) | |
| Number education (%) | |
| Number health literacy (%) | |
| Other baseline characteristics | |
| Interventions | Comparator(s) description |
| Intervention format | |
| Intervention delivery agent | |
| Intensity of the intervention | |
| Theory-based intervention | |
| Intermediate outcomes | Intermediate outcome(s) description |
| Exact measure(s) used | |
| Timing of measurement | |
| Data source | |
| Number analyzed for outcome(s) | |
| Results by group | |
| Differences by group | |
| Controlled covariates | |
| Statistical methods used | |
| Analysis adjusted for multiple comparisons | |
| Analysis adjusted for clustering effect | |
| Intention to treat analysis | |
| Ultimate outcomes | Stated outcome(s) |
| Exact measure used to measure outcome(s) | |
| Timing of measurement | |
| Data source | |
| Number analyzed for outcome(s) | |
| Results by group | |
| Differences by group | |
| Controlled covariates | |
| Statistical methods used |