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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

The value of combined cervical length measurement and fetal fibronectin testing to predict spontaneous preterm birth in asymptomatic high-risk women.

Objectives: To determine the value of the combined use of fetal fibronectin (fFN) testing and transvaginal ultrasound measurement of cervical length (CL) for prediction of preterm birth (PTB) in asymptomatic high-risk women.

Methods: One hundred and forty-seven asymptomatic women at high-risk of PTB were referred to specialist antenatal clinics and underwent CL and fFN testing over a 12-month period. Women had both tests undertaken between 22(+0) and 30(+0) weeks' gestation, on one or more occasions.

Accuracy assessment of the Dinamap ProCare 400 in pregnancy and preeclampsia.

Objective: To assess the accuracy of the Dinamap ProCare 400 in pregnancy and preeclampsia, according to the British Hypertension Society protocol.

Methods: Ethical approval was obtained. Forty-five women were recruited at two large teaching hospitals.

Validation of the Lloyds pharmacy BP11 oscillometric blood pressure monitor according to the international protocol of the European society of hypertension.

Background: The BP11 is currently one of the lowest-cost blood pressure (BP) monitors available in the UK and has sold approximately 1.5 million units since its launch in 2006. As access to home-use BP monitoring increases, it is important that such devices are validated so that consumers and clinicians can be confident of their accuracy.

Does fetal fibronectin testing change patient management in women at risk of preterm labour?

Objective: To determine clinicians' indications for, and actions following, fetal fibronectin testing in both symptomatic and asymptomatic women between 23(+0) and 34(+6) weeks' gestation.

Study Design: Following clinician education of the predictive ability of fetal fibronectin testing, results of all fetal fibronectin tests done at St Thomas' Hospital over a 6-week period were analysed. Clinicians were asked if the result changed management and if a reciprocal result would have altered management.

Validation of the Nissei DS-400 in a low-resource setting.

Objective: Hypertension affects approximately one billion individuals worldwide. The effective management of hypertension requires accurate measurement and monitoring of blood pressure. We evaluated the accuracy of a low cost self-measurement oscillometric device, with features suitable for use in a low-resource setting, in an adult population in the developing world according to the International Protocol of the European Society of Hypertension.

Validation of a non-mercury digital auscultatory device according to the European Hypertension Society protocol: Rossmax Mandaus II.

Objective: To assess the accuracy of the Rossmax Mandaus II for clinical use, according to the protocol of the European Society of Hypertension (ESH).

Methods: Thirty-nine participants were recruited to fulfill the 33 participant requirement of the protocol. Nine sequential same-arm blood pressure readings were taken by trained observers alternating between simultaneous mercury sphygmomanometer readings and the device readings.

Validation and compliance of a home monitoring device in pregnancy: microlife WatchBP home.

Objective: To assess the accuracy and patient compliance in using a novel home blood pressure monitoring device in high-risk pregnancy.

Methods: Device accuracy was assessed according to the British Hypertension Society protocol in 45 pregnant women, including 15 with preeclampsia. Twenty-one high-risk pregnant women used the device in addition to their antenatal care.

Accuracy of inflationary versus deflationary oscillometry in pregnancy and preeclampsia: OMRON-MIT versus OMRON-M7.

Objective: To assess the accuracy of the OMRON-MIT (inflationary) and OMRON-M7 (deflationary) devices for measuring blood pressure in a pregnant population, including women with preeclampsia, according to the British Hypertension Society protocol.

Methods: Forty-five pregnant women, including 15 with preeclampsia, were recruited at a large teaching hospital. Nine sequential same arm measurements were taken from each patient alternating between the test device and mercury sphygmomanometry.

Development of an accurate oscillometric blood pressure device for low resource settings.

Objective: To assess and develop an accurate blood pressure measurement device for use in low resource settings and by untrained staff, according to the World Health Organisation guidelines.

Methods: Ninety-nine adults were recruited to validate the device according to the International Protocol of the European Society of Hypertension. All participants provided written informed consent.

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.

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.

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.