Table 4.
Main reasons for rejecting validation studies by STRIDE BP (129 studies) and for rejecting studies that were published in PubMed journals as “Pass” (79 studies)
| Main reasons of validation study rejection by STRIDE BP* | STRIDE BP rejected studies (%) | ||
|---|---|---|---|
|
All (N = 129) |
Published as “Pass” (N = 79) |
||
| Device inaccurate | Key validation criteria not fulfilled | 57 (44%) | 7 (9%) |
| Incorrect study execution | Inappropriate sample size | 16 (12%) | 11 (14%) |
| Incorrect study execution | Single observer | 22 (17%) | 18 (23%) |
| Incorrect study execution | BP measurements protocol violation (sequence, number, repeats) | 37 (29%) | 29 (37%) |
| Incorrect study execution | Inadequate reference device, or cuffs for reference and test device | 13 (10%) | 8 (10%) |
| Incorrect data analysis | Inappropriate data analysis | 27 (21%) | 27 (34%) |
| Incorrect data reporting | Key validation criteria not reported | 35 (27%) | 30 (38%) |
*
Some studies with more than one major reason for rejection.