Journal article
Recommendations and Practical Guidance for performing and reporting validation studies according to the Universal Standard for the validation of blood pressure measuring devices by the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO)
- Abstract:
- In the past 30 years, several organizations have developed protocols for clinical validation of blood pressure measuring devices. An international initiative was recently launched by the US Association for the Advancement of Medical Instrumentation (AAMI), the European Society of Hypertension Working Group on Blood Pressure Monitoring (ESH) and the International Organization for Standardization (ISO), aiming to reach consensus on a universal AAMI/ESH/ISO validation standard. The purpose of this statement by the ESH Working Group on Blood Pressure Monitoring is to provide practical guidance for investigators performing validation studies according to the AAMI/ESH/ISO Universal Standard (ISO 81060–2:2018), to ensure that its stipulations are meticulously implemented and data are fully reported. Thus, this statement provides: a list of key recommendations for validation studies of intermittent non-invasive automated blood pressure measuring devices according to the AAMI/ESH/ISO Universal Standard; practical stepwise guidance for researchers performing these validation studies; a checklist for authors and reviewers of such studies; an example of a complete validation study report.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
Actions
Access Document
- Files:
-
-
(Preview, Accepted manuscript, pdf, 710.7KB, Terms of use)
-
- Publisher copy:
- 10.1097/HJH.0000000000002039
Authors
- Publisher:
- Lippincott, Williams and Wilkins
- Journal:
- Journal of Hypertension More from this journal
- Volume:
- 37
- Issue:
- 3
- Pages:
- 459–466
- Publication date:
- 2019-03-01
- Acceptance date:
- 2018-12-10
- DOI:
- EISSN:
-
1473-5598
- ISSN:
-
0263-6352
- Language:
-
English
- Keywords:
- Pubs id:
-
pubs:927454
- UUID:
-
uuid:bfa57abe-b668-4ca9-9a1c-2402e94e4316
- Local pid:
-
pubs:927454
- Source identifiers:
-
927454
- Deposit date:
-
2018-10-15
Terms of use
- Copyright holder:
- Wolters Kluwer Health
- Copyright date:
- 2019
- Rights statement:
- Copyright © 2019 Wolters Kluwer Health, Inc.
- Notes:
-
This is the accepted manuscript version of the article. The final version is available online from Lippincott, Williams and Wilkins at: https://doi.org/10.1097/HJH.0000000000002039
Note: an erratum exists for this article, originally published and available at: https://doi.org/10.1097/HJH.0000000000002383
If you are the owner of this record, you can report an update to it here: Report update to this record