Table 2. Validation Studies of Home Devices.
| Device | First Author (Year) | Protocol(s) | Population (N) | BHS Grade (SBP/DBP) | ESH Grade (SBP/DBP) | AAMI Grade (SBP/DBP) | Violations | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Pub | Adj | Pub | Adj | Pub | Adj | Major | Minor | ||||
| Microlife 3BTO-A | Nouwen (2012)∼ | ESH 02 Additional: BHS 93$ | Hypertensive preeclampsia (N=33) | B/B | B/B (BHS 93) C/C (BHS 90) | F/F | F/F | - | - | none | A, SBP, DBP |
| Reinders (2005) | BHS 93 Additional: AAMI | Pregnancy (N=105) | A/B | A/B | - | - | P/P | P/P | none | Circ | |
| Normotensive (N=35) | A/B | A/B | - | - | P/P | P/P | none | Circ | |||
| Hypertensive (N=35) | B/B | B/B | - | - | P/P | P/P | none | Circ | |||
| Preeclampsia (N=35) | A/B | A/B | - | - | P/P | P/P | none | Circ | |||
| Microlife WatchBP Home | Chung (2009) | BHS 93 Additional: AAMI | Pregnancy (N=30) | A/A | A/A | - | - | P/P | P/P | none | none |
| Preeclampsia (N=15) | B/A | B/A | - | - | P/P | P/P | none | N, Comp | |||
| Omron HEM 705 CP | Brown (1998) | Non-standard | Pregnancy (N=50) | - | - | - | - | - | - | - | - |
| Gupta (1997) | BHS 93 Additional: AAMI | Pregnant w/o preeclampsia (N=85) | B/B | B/B | - | - | F/F | F/F | none | Circ, SBP, DBP | |
| Preeclampsia (N=42) | C/D | C/D | - | - | F/F | F/F | none | Circ, SBP, DBP | |||
| Lo (2002) | Non-standard | Healthy pregnancy (N=101) | - | - | - | - | - | - | - | - | |
| Preeclampsia (N=45) | - | - | - | - | - | - | - | - | |||
| Omron-M7 | De Greeff (2009) | BHS 93 Additional: AAMI | Pregnancy & preeclampsia (N=45) | A/A | A/A | - | - | P/P | P/P | none | Circ ^ |
| Normotensive (N=30) | A/A | A/A | - | - | P/P | P/P | none | Circ ^ | |||
| Preeclampsia (N=15) | B/B | B/B | - | - | P/P | F/P | N, Comp | Circ ^ | |||
| Nouwen (2012)∼ | ESH 02 Additional: BHS 93$ | Hypertensive preeclampsia (N=33) | B/A | B/A (BHS 93) C/B (BHS 90) | F/P | F/P | - | - | none | A, SBP, DBP | |
| Omron-MIT | De Greeff (2009) | BHS 93 Additional: AAMI | Pregnancy & preeclampsia (N=45) | A/A | A/A | - | - | P/P | P/P | none | none |
| Normotensive (N=30) | A/A | A/A | - | - | P/P | P/P | none | none | |||
| Preeclampsia (N=15) | A/A | A/A | - | - | P/P | P/P | N, Comp | none | |||
| Omron-MIT Elite | Chung (2012)∼ | BHS 93 Additional: AAMI | Pregnancy & preeclampsia (N=45) | A/A | A/A | - | - | P/P | P/P | none | SBP, DBP |
| Normotensive (N=30) | A/A | A/A | - | - | P/P | P/P | none | none | |||
| Preeclampsia (N=15) | A/A | A/A | - | - | P/P | P/P | none | N, Comp | |||
| James (2017)† | BHS 93 | Pregnancy with arm circumference >= 32 cm (N=46) | D/D | C/D | - | - | - | - | none | none | |
| Omron T9P | Brown (2011)∼ | BHS 90 Additional: AAMI | Pregnancy (N=85) | A/A* | A/A (BHS 93) B/B (BHS 90) | - | - | P/P | P/P | G* | SBP, DBP |
| Takeda UA-751 | Brown (1991) | Non-standard | Pregnancy (N=79) | - | - | - | - | - | - | - | - |
| Withings BP-800 | Hay (2016) | BHS 93 | Normotensive, hypertensive, and preeclampsia (N=47) | C/B | C/B | - | - | - | - | none | none |
Note: When more than one protocol is listed, the first protocol is the methodology followed for the validation study and additional protocols are listed when their grading criteria were applied to the data.
Individual studies are indicated by bold type in the population column. Shaded rows indicate studies that passed the primary protocol.
authors state device can be used for home or clinical use; †authors do not specify device type, so prior authors' designation followed (data is also found in Table 3).
Protocol Modification: BHS 90 protocol cited in references, but BHS 93 grading was used.
Protocol Modification: BHS 90 protocol was followed, but BHS 93 grading was used.
two devices were tested MIT can only accommodate an arm circumference of 22-32 cm M7 can accommodate up to 42cm. Only women with an arm circumference 22-32 cm were included.
Abbreviations: Pub= published grade; Adj= adjudicated grade; A= age, T=trimester, SBP= systolic blood pressure range, DBP= diastolic blood pressure range, Circ= arm circumference, N= number of participants, Comp= number of BP comparisons, Timing= Device v. Mercury simultaneous/sequential, Obs= observer measurementssimultaneous/sequential, G= final grade; NR= not reported; NG= not able to adjudicate a grade.