Objective: Although a large variety of automated blood pressure devices are available, only some have been validated for use in clinical practice. The British Hypertension Society (BHS) recommends separate validation of automated devices in special subgroups, e.g. the elderly and pregnant women. The aim of this study was to compare the Finometer (FM) and the earlier validated SpaceLabs 90207 (SL) with standard auscultatory blood pressure measurements in normal, pre-eclamptic and hypertensive pregnancy, following the guidelines of the BHS and the Association for the Advancement of Medical Instrumentation (AAMI).
Methods: The total study group consisted of 123 pregnant women, of whom were 54 normotensive, 31 pre-eclamptic and 38 hypertensive. Automated readings with the FM and SL were compared with auscultatory blood pressure measurements. Bland-Altman plots, BHS grades, mean pressure differences and 95% limits of agreement were used for analysis.
Results: Bland-Altman plots showed a wide scatter of the pressure differences between auscultatory and automated measurements. FM achieved BHS grades C/D, C/B, D/D and D/D in the total, normotensive, pre-eclamptic and hypertensive group, respectively. The AAMI criteria were only met for diastolic blood pressure in the normotensive group. For SL almost identical BHS grades and 95% limits of agreement as compared to our earlier study were found.
Conclusions: The accuracy and precision of the Finometer are not sufficient for determination of absolute blood pressure levels in individual pregnant women. Our present findings on the SpaceLabs 90207 reconfirm our earlier results.