Accuracy of automated cuff blood pressure monitors in special populations: International Organization for Standardization (ISO) Task Group report and call for research.

OBJECTIVE: Automated cuff blood pressure (BP) devices are widely used for ambulatory, home, and office BP measurement. However, an automated device, which is accurate in the general adult population may be inaccurate in some special populations. A 2018 Collaborative Statement by the US Association for the Advancement of Medical Instrumentation, the European Society of Hypertension, and the International Organization for Standardization (ISO) considered three special populations requiring separate validation (age <3 years, pregnancy, and atrial fibrillation). An ISO Task Group was appointed to identify evidence for additional special populations. METHOD: Evidence on potential special populations was identified from the STRIDE BP database, which performs systematic PubMed searches for published validation studies of automated cuff BP monitors. Devices that passed in a general population, but failed in potential special populations were identified. RESULTS: Of 338 publications (549 validations, 348 devices) in the STRIDE BP database, 29 publications (38 validations, 25 devices) involved 4 potential special populations: (i) age 12-18 years: 3 of 7 devices failed but passed in a general population; (ii) age more than 65 years: 1 of 11 devices failed but passed in a general population; (iii) diabetes type-2: 4 devices (all passed); (iv) chronic kidney disease: 2 of 7 devices failed but passed in a general population. CONCLUSION: Some evidence suggest that the automated cuff BP devices may have different accuracy in adolescents and in patients with chronic kidney disease than in the general population. More research is needed to confirm these findings and investigate other potential special populations.

A universal standard for the validation of blood pressure measuring devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement.

: In the last 30 years, several organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring and the International Organization for Standardization (ISO) have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers and manufacturers would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an international initiative was taken by AAMI, ESH and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.

A Universal Standard for the Validation of Blood Pressure Measuring Devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement.

In the past 30 years, several organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring, and the International Organization for Standardization (ISO), have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers, and manufacturers, would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an international initiative was taken by the AAMI, ESH, and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH, and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.

Comparison of an ecabet sodium and proton pump inhibitor (PPI) combination therapy with PPI alone in the treatment of endoscopic submucosal dissection (ESD)--induced ulcers in early gastric cancer: prospective randomized study.

BACKGROUND/AIMS: Ecabet sodium (ES) is a widely employed mucoprotective agent, for the treatment of gastric ulcers. The present paper prospectively evaluate the additive benefits of using ES in combination with the rabeprazole proton pump inhibitor (PPI) for the treatment of gastric ulcers after endoscopic submucosal dissection (ESD). METHODOLOGY: A total of 56 patients who had undergone ESD for early gastric cancers were randomly assigned to receive either PPI with ES (P/ES group, n=28) or PPI alone (PPI group, n=28) for 8 weeks. At 4 and 8 weeks after ESD, the healing rate and the diminution rate of the ulcers were compared between two groups by endoscopy. RESULTS: One patient in the PPI group developed a hemorrhage as a result of an ESD-induced ulcer. At 4 weeks, the healing rates were significantly higher in the P/ES group (40.7%) compared with the PPI group (11.5%), (p = 0.0013). This tendency was observed also at 8 weeks (p = 0.0446). In addition, at 4 weeks, the diminution rates of the ESD-induced ulcers were significantly higher in the P/ES group (95.8%) than in the PPI group (84.9%), (p=0.0033). CONCLUSIONS: ES in combination with PPI facilitates increased healing of ESD-induced ulcers, and can also improve the quality of ulcer healing.

The clinical characteristics, endoscopic treatment, and prognosis for patients presenting with duodenal varices.

BACKGROUND/AIMS: This study investigated the clinical characteristics, endoscopic appearances, usefulness of endoscopic treatments, and survival of patients with duodenal varices. METHODOLOGY: Twelve patients were evaluated in whom endoscopy confirmed duodenal varices (13 lesions), and patient data was retrospectively analyzed regarding underlying diseases, hepatic function, endoscopic appearance, previous treatment for other complicated varices, endoscopic treatment for hemorrhage from duodenal varices, and survival. RESULTS: Underlying diseases consisted of liver cirrhosis in 8 patients, and pancreatic cancer-related pylemphraxis in 4 patients. Endoscopic appearances of hemorrhage from duodenal varices revealed negative red color (RC) signs in all 6 lesions, and 5 of 6 lesions were F3 lesions. Three of 5 patients with hemorrhagic duodenal varices had received treatment for esophageal varices. Successful hemostasis and complete eradication by endoscopic treatments was achieved in all 5 patients (6 lesions). The 1, 3, and 5 year cumulative survival rates were 66.7%, 48.6%, and 36.5% in the patients with duodenal varices. CONCLUSIONS: The hemorrhagic factor of duodenal varices is F factor, but not RC sign. Changes of blood flow in the collateral circulatory pathway after treatment for esophageal varices may increase the risk of hemorrhage from duodenal varices. Endoscopic treatment is useful for hemorrhagic duodenal varices.

Endoscopic ultrasonography with three miniature probes of different frequency is an accurate diagnostic tool for endoscopic submucosal dissection.

BACKGROUND/AIMS: Endoscopic ultrasound (EUS) examinations are necessary to determine the vertical cancer invasion depth. In this study, we prospectively performed EUS with three miniature probes of different frequency (12, 20, and 30 MHz) in patients with early gastric cancer scheduled for endoscopic submucosal dissection (ESD) based on endoscopic findings. METHODOLOGY: The study included 142 early gastric cancer lesions in 132 patients in our hospital. We then evaluated the diagnostic accuracy of the use of three miniature probes of different frequency in the determination of vertical margins. Finally, we evaluated the value of EUS as an additional examination tool used along with conventional endoscopic findings for determination of indication for ESD. RESULTS: The accuracies of the early gastric cancer invasion depths of the m+sm1 group were 81.0%, 86.0% and 92.3% as measured by the 12-, 20- and 30-MHz probes, respectively. Even though ulceration was associated with the lesions, the 30-MHz probe was the most accurate as compared to the 12- or 20-MHz probes in the m+sml cancer group. CONCLUSIONS: EUS examinations with probes of varying frequency are useful for determining appropriate treatment strategies for early gastric cancer.