Shock index thresholds to predict adverse outcomes in maternal hemorrhage and sepsis: A prospective cohort study.

INTRODUCTION: Shock index (SI) is a predictor of hemodynamic compromise in obstetric patients. The SI threshold for action is not well understood. We aimed to evaluate SI thresholds as predictors of outcomes in obstetric patients. MATERIAL AND METHODS: We undertook a prospective cohort study at three South African hospitals of women with postpartum hemorrhage (n = 283) or maternal sepsis (n = 126). The "first" and "worst" SI following diagnosis were recorded. SI was compared with conventional vital signs as predictors of outcomes. The performance of SI <.9, SI .9-1.69 and SI ≥1.7 to predict outcomes (maternal death; Critical Care Unit admission; major procedure; hysterectomy) and hemorrhage-specific outcomes (lowest hemoglobin <70 g/l; blood transfusion ≥4 IU) were evaluated. RESULTS: "First" SI was one of two best performing vital signs for every outcome in postpartum hemorrhage and sepsis. In hemorrhage, risk of all outcomes increased with increasing "first" SI; for blood transfusion ≥4 IU odds ratio was 4.24 (95% confidence interval 1.25-14.36) for SI ≥1.7 vs SI .9-1.69. In sepsis, risk of all outcomes increased with increasing "worst" SI. Sensitivity, specificity, positive and negative predictive values of "first" SI <.9 vs SI ≥.9 for maternal death were 100.0%, 55.2%, 4.6% and 100.0%, respectively, in hemorrhage and 80.0%, 50.4%, 12.3% and 96.7%, respectively, in sepsis. CONCLUSIONS: The shock index was a consistent predictor of outcomes compared with conventional vital signs in postpartum hemorrhage and sepsis. SI <.9 performed well as a rule-out test and SI .9-1.69 and SI ≥1.7 indicated increased risk of all outcomes in both cohorts. These thresholds may alert to the need for urgent intervention and prevent maternal deaths.

The CRADLE vital signs alert: qualitative evaluation of a novel device designed for use in pregnancy by healthcare workers in low-resource settings.

BACKGROUND: Vital signs measurement can identify pregnant and postpartum women who require urgent treatment or referral. In low-resource settings, healthcare workers have limited access to accurate vital signs measuring devices suitable for their environment and training. The CRADLE Vital Signs Alert (VSA) is a novel device measuring blood pressure and pulse that is accurate in pregnancy and designed for low-resource settings. Its traffic light early warning system alerts healthcare workers to the need for escalation of care for women with hypertension, haemorrhage or sepsis. This study evaluated the usability and acceptability of the CRADLE VSA device. METHODS: Evaluation was conducted in community and primary care settings in India, Mozambique and Nigeria and tertiary hospitals in South Africa. Purposeful sampling was used to convene 155 interviews and six focus groups with healthcare workers using the device (n = 205) and pregnant women and their family members (n = 41). Interviews and focus groups were conducted in the local language and audio-recorded, transcribed and translated into English for analysis. Thematic analysis was undertaken using an a priori thematic framework, as well as an inductive approach. RESULTS: Most healthcare workers perceived the CRADLE device to be easy to use and accurate. The traffic lights early warning system was unanimously reported positively, giving healthcare workers confidence with decision-making and a sense of professionalism. However, a minority in South Africa described manual inflation as tiring, particularly when measuring vital signs in obese and hypertensive women (n = 4) and a few South African healthcare workers distrusted the device's accuracy (n = 7). Unanimously, pregnant women liked the CRADLE device. The traffic light early warning system gave women and their families a better understanding of the importance of vital signs in pregnancy and during the postpartum period. CONCLUSION: The CRADLE device was well accepted by healthcare workers from a range of countries and levels of facility, including those with no previous vital signs measurement experience. The device motivated women to attend primary care and encouraged them to accept treatment and referral.

Validation of the Spacelabs 90227 OnTrak device according to the European and British Hypertension Societies as well as the American protocols.

OBJECTIVE: To assess the static device accuracy of the Spacelabs 90227 OnTrak according to the three most recognized validation protocols, in both adults and children. METHODS: Subjects were recruited and data gathered and analysed according to the European Society of Hypertension (ESH-IP2), the British Hypertension Society (BHS) and the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Standards Organization (ANSI/AAMI/ISO) protocols. RESULTS: The device achieved a mean difference ± SD between observers and device for SBP/DBP was 0.9 ± 7/-1.4 ± 6 mmHg (ESH-IP2) and 1.7 ± 8/-1.5/6 mmHg (BHS) Grade A/A. For the ANSI/AAMI/ISO protocol, the average device-observer difference for SBP/DBP was 0.4 ± 7/-1.5 ± 7 mmHg fulfilling the two criteria of the protocol. CONCLUSION: The Spacelabs 90227 OnTrak device achieved the criteria of all three recognised validation protocols and can therefore be recommended for clinical use as a static device.

Pregnancy-Related Acute Kidney Injury in Preeclampsia: Risk Factors and Renal Outcomes.

Preeclampsia is a common cause of acute kidney injury (AKI) in low- and middle-income countries, but AKI incidence in preeclampsia, its risk factors, and renal outcomes are unknown. A prospective observational multicenter study of women admitted with preeclampsia in South Africa was conducted. Creatinine concentrations were extracted from national laboratory databases for women with maximum creatinine of ≥90 µmol/L (≥1.02 mg/dL). Renal injury and recovery were defined by Kidney Disease Improving Global Outcomes creatinine criteria. Predefined risk factors, maternal outcomes, and neonatal outcomes were compared between AKI stages. Of 1547 women admitted with preeclampsia 237 (15.3%) met AKI criteria: 6.9% (n=107) stage 1, 4.3% (n=67) stage 2, and 4.1% (n=63) stage 3. There was a higher risk of maternal death (n=7; relative risk, 4.3; 95% CI, 1.6-11.4) and stillbirth (n=80; relative risk, 2.2; 95% CI, 1.8-2.8) in women with AKI compared with those without. Perinatal mortality was also increased (89 of 240; 37.1%). Hypertension in a previous pregnancy was the strongest predictor of AKI stage 2 or 3 (odds ratio, 2.24; 95% CI, 1.21-4.17). Renal recovery rate reduced with increasing AKI stage. A third of surviving women (76 of 230 [33.0%]) had not recovered baseline renal function by discharge. Approximately half (39 of 76; 51.3%) of these women had no further creatinine testing post-discharge. In summary, AKI was common in women with preeclampsia and had high rates of associated maternal and perinatal mortality. Only two-thirds of women had confirmed renal recovery. History of a previous hypertensive pregnancy was an important risk factor.

The Rossmax (ME 701 series) upper arm device: accuracy assessment in an adult population according to the International and the British Hypertension Society protocols.

OBJECTIVE: Any device intended for blood pressure measurement should be subjected to an independent accuracy assessment. This is particularly relevant to automated oscillometric devices that do not use Korotkoff sounds to identify blood pressure. Various validation protocols have been published with the view of standardizing the acceptable level of accuracy for such devices. We evaluated the accuracy of the Rossmax (ME 701 series, Taipei, Taiwan) device according to the International protocol of the European Society of Hypertension and the British Hypertension Society (BHS) protocol. METHODS: Local ethics committee approval was obtained and 91 participants were recruited from the staff and patients at a large teaching hospital. Two trained observers took nine sequential same arm measurements from each participant. Initially, the data from 33 participants were analysed according to the International protocol guidelines. A further 52 participants were then included to fulfil the BHS protocol requirement of 85 participants. RESULTS: The Rossmax (ME 701 series) device passed the criteria for both the International and the BHS protocols and achieved an A/A grade. The mean difference and standard deviation for systolic and diastolic pressures according to the International protocol [-0.1 (6.2) mmHg and -2.8 (5.3) mmHg] and the BHS protocol [1.5 (7.6) mmHg and -1.2 (6.1) mmHg] also meet the requirements of the Association for the Advancement of Medical Instrumentation that is

Validation of the Omron M7 (HEM-780-E) oscillometric blood pressure monitoring device according to the British Hypertension Society protocol.

BACKGROUND: The Omron M7 (HEM-780-E) is an automated oscillometric upper arm blood pressure monitor for the professional and home use markets. The aim of this study was to validate the accuracy of this device according to the British Hypertension Society (BHS) and the Association for the Advancement of Medical Instrumentation (AAMI) SP10 validation criteria. METHODS: Participants were recruited until a total of 85 were obtained that filled the blood pressure ranges specified by the BHS protocol. Recruitment to the study was from the general medical and specialist clinics and from the staff at Guy's and St Thomas' Hospital in London, UK. Nine sequential same-arm blood pressure readings were taken from each participant by two trained observers, alternating between a mercury reference sphygmomanometer and the Omron M7 (HEM-780-E). The differences between the reference and test device readings, for both systolic and diastolic pressures, were compared with BHS and AAMI criteria to determine the outcome of the study. RESULTS: The Omron M7 (HEM-780-E) is graded 'A' for systolic and 'A' for diastolic blood pressures according to the BHS criteria. The mean (standard deviation) of the difference between the observer and the device measurements was 0.75+/-6.5) mmHg for systolic and 1.33+/-5 mmHg for diastolic pressures. The device, therefore, also satisfies the AAMI SP10 standard for the study population, which requires differences of <+/-5 (8) mmHg. CONCLUSION: The Omron M7 (HEM-780-E) achieved an 'A/A' performance classification under the BHS criteria and passed the AAMI requirements for the study population. It can be recommended for professional and home-use in this population.

Accuracy assessment of the Tensoval duo control according to the British and European Hypertension Societies' standards.

OBJECTIVE: Noninvasive blood pressure (BP) measurement is dependent on either auscultation or oscillometry. The Tensoval duo control device uses auscultatory and/or oscillometric technology to determine BP. We evaluated the accuracy of this device in adults according to the British Hypertension Society (BHS) protocol and the International Protocol of the European Hypertension Society. METHODS: Ethical approval was obtained and participants gave written informed consent. Eighty-five participants who fulfilled the protocol criteria were recruited. Nine sequential same arm measurements were taken from each participant by two trained observers, comparing the device to mercury sphygmomanometery. Data analysis was performed according to the respective protocol guidelines. RESULTS: The device achieved an A grade for both systolic and diastolic pressures with 68, 91 and 98% of systolic and 73, 91 and 98% of diastolic differences within the

A self-measurement device suitable for hospital use: validation of the Spengler Pro M according to the International Protocol of the European Society of Hypertension.

OBJECTIVE: Hypertension affects the global population. The effective management of hypertension requires accurate measurement and monitoring of blood pressure. We evaluated the accuracy of a self-measurement device, with features suitable for hospital practice, in an adult population according to the International Protocol of the European Society of Hypertension. METHODS: After ethical approval, trained observers using a double-headed stethoscope took nine sequential same arm measurements from 33 participants, alternating between mercury sphygmomanometry and the test device. Anyone with an arrhythmia or unclear Korotkoff sounds was excluded. Data was analyzed according to the protocol guidelines. RESULTS: The device passed all the criteria of the International Protocol with 79/94/97 and 72/92/97 of systolic and diastolic differences, respectively within 5/10/15 mmHg of the mercury standard. It also achieved the Association for the Advancement of Medical Instrumentation criteria with a mean difference (standard deviation) of -0.3 (5.8) mmHg for systolic and -0.4 (6.4) mmHg for diastolic pressure. CONCLUSION: The Spengler Pro M device can be recommended for clinical use in an adult population, according to the International Protocol of the European Society of Hypertension. Accuracy in special populations such as those with an arrhythmia or diabetes should be investigated separately.

Blood pressure measuring devices: ubiquitous, essential but imprecise.

Blood pressure measurement is an essential, poorly performed skill, traditionally undertaken through auscultation and use of a mercury sphygmomanometer. However, its exclusivity to the clinical environment has changed substantially over the last 20 years with the introduction of automated blood pressure devices. This simplified self-measurement method has enabled increased patient involvement and surveillance, while also eliminating the observer error, measurement bias and white-coat effect associated with auscultatory measurement in the clinical setting. Rapid advances in technology have decreased the discrepancy between automated and auscultatory readings, evidenced by the increased number of devices to pass recognized validation standards. However, the limitation of automated device accuracy is still evident in certain patient groups, such as those with diabetes, an arrhythmia or preeclampsia. Therefore, careful consideration is warranted when selecting a noninvasive blood pressure measurement device to ensure optimum accuracy and reliability of readings.

Maternal and perinatal adverse outcomes in women with pre-eclampsia cared for at facility-level in South Africa: a prospective cohort study.

BACKGROUND: Hypertensive disorders of pregnancy contribute to 14% of all maternal deaths, the majority of which occur in low- and middle-income countries. The aim of the study was to describe the maternal and perinatal clinical outcomes of women with pre-eclampsia living in middle- and low-income countries. METHODS: The study was a prospective observational study of women with pre-eclampsia (n = 1547, 42 twin pregnancies) at three South African tertiary facilities. Using stepwise logistic regression model area under the receiver operating characteristic curve (AUROC) values, the association between maternal baseline and admission characteristics and risk of adverse outcomes was evaluated. Main outcome measures were eclampsia, kidney injury and perinatal death. RESULTS: In 1547 women with pre-eclampsia, 16 (1%) died, 147 (9.5%) had eclampsia, four (0.3%) had a stroke and 272 (17.6%) had kidney injury. Of the 1589 births, there were 332 (21.0%) perinatal deaths; of these, 281 (84.5%) were stillbirths. Of 1308 live births, 913 (70.0%) delivered <37 completed weeks and 544 (41.7%) delivered <34 weeks' gestation. Young maternal age (AUROC = 0.76, 95% confidence interval (CI) = 0.71-0.80) and low Body Mass Index BMI (AUROC 0.65, 95% CI = 0.59-0.69) were significant predictors of eclampsia. Highest systolic blood pressure had the strongest association with kidney injury, (AUROC = 0.64, 95% CI = 0.60-0.68). Early gestation at admission was most strongly associated with perinatal death (AUROC = 0.81, 95% CI = 0.77-0.84). CONCLUSIONS: The incidence of pre-eclampsia complications, perinatal death and preterm delivery in women referred to tertiary care in South Africa was much higher than reported in other low- and middle-income studies and despite access to tertiary care interventions. Teenage mothers and those with low BMI were at highest risk of eclampsia. This information could be used to inform guidelines, the research agenda and policy.

Early warning system hypertension thresholds to predict adverse outcomes in pre-eclampsia: A prospective cohort study.

OBJECTIVES: To evaluate the association between blood pressure (BP) measurements and adverse outcomes in women with pre-eclampsia. STUDY DESIGN: A prospective cohort study of women with pre-eclampsia admitted to three South African tertiary facilities. BP was measured using the CRADLE Vital Signs Alert (VSA), incorporated with a traffic light early warning system; green: systolic BP <140 mmHg and diastolic BP <90 mmHg, yellow: systolic BP 140-159 and/or diastolic BP 90-109 mmHg (but neither is above the upper threshold), red: systolic BP ≥160 mmHg and/or diastolic BP ≥110 mmHg. MAIN OUTCOME MEASURES: Maternal: death, eclampsia, stroke, kidney injury; process measures: magnesium sulfate use, Critical Care Unit (CCU) admission; perinatal: stillbirth, neonatal death, preterm delivery. RESULTS: Of 1547 women with pre-eclampsia (including 42 twin pregnancies), 33.0% of women triggered a red light on admission and 78.6% at their highest BP. Severe hypertension and adverse outcomes were common across yellow and red categories. Comparing admission red to yellow lights, there was a significant increase in kidney injury (OR 1.74, CI 1.31-2.33, trend test p = .003), magnesium sulfate use (OR 3.40, CI 2.24-5.18, p < .001) and CCU admission (OR 1.50, CI 1.18-1.91, p < .001), but not for maternal death, eclampsia, extended perinatal death or preterm delivery. CONCLUSION: The CRADLE VSA, with integrated traffic light early warning system, can identify women who are hypertensive, at increased risk of severe pre-eclampsia complications and in need of escalation of care. Women who triggered a red light were at increased risk of kidney injury, magnesium sulfate use and CCU admission.

Development and evaluation of a novel Vital Signs Alert device for use in pregnancy in low-resource settings.

OBJECTIVES: Haemorrhage, hypertension, sepsis and abortion complications (often from haemorrhage or sepsis) contribute to 60% of all maternal deaths. Each is associated with vital signs (blood pressure (BP) and pulse) abnormalities, and the majority of deaths are preventable through simple and timely intervention. This paper presents the development and evaluation of the CRADLE Vital Signs Alert (VSA), an accurate, low-cost and easy-to-use device measuring BP and pulse with an integrated traffic light early warning system. The VSA was designed to be used by all cadres of healthcare providers for pregnant women in low-resource settings with the aim to prevent avoidable maternal mortality and morbidity. METHODS: The development and the mixed-methods clinical evaluation of the VSA are described. RESULTS: Preliminary fieldwork identified that introduction of BP devices to rural clinics improved antenatal surveillance of BP in pregnant women. The aesthetics of the integrated traffic light system were developed through iterative qualitative evaluation. The traffic lights trigger according to evidence-based vital sign thresholds in hypertension and haemodynamic compromise from haemorrhage and sepsis. The VSA can be reliably used as an auscultatory device, as well as its primary semiautomated function, and is suitable as a self-monitor used by pregnant women. CONCLUSION: The VSA is an accurate device incorporating an evidence-based traffic light early warning system. It is designed to ensure suitability for healthcare providers with limited training and may improve care for women in pregnancy, childbirth and in the postnatal period.

The Health and Life device (HL888HA): accuracy assessment in an adult population according to the British Hypertension Society protocol.

OBJECTIVE: Over the last two decades, concerns over mercury toxicity have given rise to the continuous release of new and improved automated blood pressure measurement devices as a replacement for the mercury sphygmomanometer. Out-of-office blood pressure monitoring has been shown to have various advantages, including a reduced white-coat effect and observer error, as well as better prediction of cardiovascular risk/complications. We assessed the accuracy of the Health and Life device (HL888HA) (Health and Life Co. Ltd., Taipei, Taiwan) in an adult population according to the British Hypertension Society protocol. METHODS: Local ethics committee approval was obtained and participants were recruited from a large teaching hospital. Nine blood pressure measurements were taken from each participant, alternating between a mercury sphygmomanometer and the test device. Data from 85 participants who fulfilled the British Hypertension Society criteria were analysed according to the protocol guidelines. RESULTS: The device achieved the highest possible grade (A/A) according to the British Hypertension Society protocol. The mean difference and SD of 0.5 (7.3) mmHg for systolic and -2.1 (7.8) mmHg for diastolic pressure, which complies with the standard of the American Association for the Advancement of Medical Instrumentation. CONCLUSION: The Health and Life device (HL888HA) can be recommended for use in an adult population according to the criteria of the British Hypertension Society protocol.

Clinical assessment of the DINAMAP ProCare monitor in an adult population according to the British Hypertension Society Protocol.

OBJECTIVE: Clinical recommendation of an automated blood pressure device is dependent on assessment according to a recognized protocol. The DINAMAP ProCare monitor is an oscillometric device intended for hospital, physician office or clinic use. The device algorithm was developed and tested against an auscultatory standard to increase comparability, in contrast to previous DINAMAP products that were designed to be accurate compared with an invasive central aortic reference, as specified in the Association for the Advancement of Medical Instrumentation-SP10 Standard (AAMI SP10 Standard: 1992, 2002). This device was validated in an adult population according to the protocol of the British Hypertension Society. METHODS: Local ethics committee approval was obtained and all patients were required to give written informed consent. Nine sequential same-arm measurements, alternating between observer and device, were taken from each patient. Data analysis was performed according to the guidelines of the British Hypertension Society protocol on 85 patients who fulfilled the blood pressure categories specified by the protocol. RESULTS: The DINAMAP ProCare monitor achieved an A grade for both systolic and diastolic pressures. It also achieved the passing criteria of the ANSI/AAMI SP10 with a mean difference (standard deviation) for systolic and diastolic pressures, respectively, of -0.3 (6.9) and -4.0 (5.9) mmHg. CONCLUSION: The DINAMAP ProCare monitor can be recommended for clinical use in an adult population according to the criteria of the British Hypertension Society.

Clinical accuracy of a low cost portable blood pressure device in pregnancy and pre-eclampsia: the Nissei DS-400.

Hypertensive disorders of pregnancy cause significant maternal morbidity and mortality worldwide, particularly in developing countries. This study evaluated the accuracy of the Nissei DS-400, a low cost blood pressure (BP) device, in pregnancy according to the British Hypertension Society protocol. Forty-five pregnant women (15 with pre-eclampsia), were recruited from a large teaching hospital. Nine sequential same-arm BP measurements were taken from each woman by trained observers, alternating between mercury sphygmomanometry and the device. The Nissei DS-400 achieved the highest accuracy grade (A/A) in all subjects (n = 45) and in pregnancy alone (n = 30). The mean difference ± standard deviation between the standard and the device in pregnancy were -1.0 ± 5.1 mmHg and -1.1 ± 5.0 mmHg for systolic and diastolic BP, respectively, and -2.6 ± 5.9 mmHg and -3.4 ± 5.8 mmHg in all subjects. The Nissei-DS 400 can be recommended for clinical use in pregnancy and has potential as a good screening tool for pre-eclampsia in low resource settings.

An accurate semiautomated oscillometric blood pressure device for use in pregnancy (including pre-eclampsia) in a low-income and middle-income country population: the Microlife 3AS1-2.

OBJECTIVES: To assess the accuracy of the Microlife 3AS1-2 blood pressure device in pregnancy and pre-eclampsia in a low-resource setting. METHODS: Prospective validation according to the British Hypertension Society protocol. A total of 45 pregnant women were recruited from Kimberley Hospital (South Africa), of whom 15 had pre-eclampsia. RESULTS: The Microlife 3AS1-2 device achieved an overall B/A grade in pregnancy (including pre-eclampsia), passing the British Hypertension Society protocol requirements and achieving the International Organization for Standardization standard with a mean difference and SD of -3.8 ± 7.3 and -1.5 ± 6.2 mmHg for systolic and diastolic pressures, respectively. CONCLUSION: The Microlife 3AS1-2 device can be recommended for use in pregnancy, including pre-eclampsia. In addition, it fulfils the requirements stipulated by the WHO for an automated blood pressure device suitable for use in a low-resource setting. This makes it the ideal device for antenatal clinics and primary healthcare facilities in low-income and middle-income countries.

Accuracy validation of the Microlife 3AS1-2 blood pressure device in a pregnant population with low blood pressure.

OBJECTIVE: To assess the accuracy of the Microlife 3AS1-2 blood pressure (BP) device in pregnant women with low BP to investigate suitability for hypotensive detection in low-income and middle-income countries. METHODS: A prospective observational study was carried out evaluating the Microlife 3AS1-2, a hand-held, upper-arm, semiautomated BP device, according to British Hypertension Society (BHS) protocol methods. Thirty (stable) pregnant women with a clinical systolic BP less than 100 mmHg and/or diastolic BP less than 60 mmHg were recruited from antenatal wards and clinics and their BP was measured by three trained observers at a district-level hospital in South Africa. Accuracy was assessed according to the BHS grading criteria (A/B=pass) and the ANSI/AAMI/ISO standard for mean difference and SD (≤5±8 mmHg). RESULTS: The device achieved an A/A grade according to the BHS grading criteria. The mean difference±SD between the observer and the test device was 0.5±6.2 and 1.3±5.4 mmHg for systolic and diastolic BP, respectively, fulfilling the standard required by the ANSI/AAMI/ISO protocol. All observer differences were within 4 mmHg. CONCLUSION: According to the BHS protocol, the Microlife 3AS1-2 BP device is accurate in pregnant women with low BP. The device has been validated previously in pregnancy and pre-eclampsia and also fulfils the criteria of the WHO for use in a low-resource setting. Although unstable women were not included in this validation (for safety and pragmatic reasons), this device could potentially improve the detection of shock secondary to obstetric haemorrhage or sepsis, as well as being used in pre-eclampsia, particularly in low-income and middle-income countries.

Validation of the Tensoval Duo Control II blood pressure monitor for clinic use and self-measurement according to the British Hypertension Society protocol and the European Society of Hypertension International Protocol Revision 2010.

OBJECTIVE: The Tensoval Duo Control II is an automated upper arm device that uses a combination of oscillometric and auscultatory technology to determine blood pressure noninvasively. The accuracy of this device was assessed according to the British Hypertension Society (BHS) protocol and the European Society of Hypertension International Protocol revision 2010 (ESH-IP2) in an adult population. METHODS: Ethical approval was obtained. Eighty-five and 33 adult individuals, respectively, were recruited to fulfil the requirements of each protocol. Trained observers took nine sequential same-arm measurements alternating between a mercury sphygmomanometer and the device. The device had to achieve at least a B grade for both systolic and diastolic pressures to pass the BHS protocol and had to fulfil the criteria of all three phases of the ESH-IP2 protocol to receive recommendation. RESULTS: The device achieved an A/A grading for the BHS protocol and passed all three phases of the ESH-IP2 protocol. The mean difference±SD for the BHS/ESH protocols, respectively, was -1.8±6.5/-0.7±5.7 mmHg for systolic pressure and 1.9±5.1/2.4±4.5 mmHg for diastolic pressure. The device maintained its A/A grading throughout the low-pressure, medium-pressure and high-pressure ranges. CONCLUSION: The Tensoval Duo Control II device is recommended for clinical and home use according to both the BHS and the ESH-IP2 standard.

Introduction of automated blood pressure devices intended for a low resource setting in rural Tanzania.

Regular blood pressure (BP) monitoring is a cost-effective means of early identification and management of hypertensive disease in pregnancy. In much of rural sub-Saharan Africa, the ability to take and act on accurate BP measurements is lacking as a result of poorly functioning or absent equipment and/or inadequate staff education. This study describes the feasibility of using validated automated BP devices suitable for low-resource settings (LRS) in primary health-care facilities in rural Tanzania. Following a primary survey, 19 BP devices were distributed to 11 clinics and re-assessed at one, three, six, 12 and 36 months. Devices were used frequently with high levels of user satisfaction and good durability. We conclude that the use of automated BP devices in LRS is feasible and sustainable. An assessment of their ability to reduce maternal and perinatal morbidity and mortality is vital.

Accuracy assessment of a novel blood pressure measurement device in a South African adult population: Tensoval duo control.

OBJECTIVE: The Tensoval duo control device uses a novel combination of auscultatory and oscillometric technology to measure blood pressure. We assessed the accuracy of this device in a South African adult population according to the International Protocol of the European Society of Hypertension. METHODS: Ethical approval was obtained and 33 participants were recruited from Kimberley Hospital Complex (South Africa). Trained observers took sequential same arm blood pressure measurements from each participant, alternating between mercury sphygmomanometery and the device. RESULTS: The Tensoval duo control passed all the phases of the protocol and achieved a mean difference ± SD of -3.2 ± 7.2 and 2.0 ± 6.0 mmHg for systolic and diastolic pressures, respectively. CONCLUSION: This study confirms the accuracy and recommendation for clinical use of the Tensoval duo control device in adults. Accuracy in special patient groups is yet to be assessed, but this novel technology could be particularly valuable in those with vascular disease.